[47 Pa.B. 1300]
[Saturday, March 4, 2017]

[Continued from previous Web Page]

§ 23.83(b)(1)—Diphtheria, tetanus and pertussis

 The March of Dimes supported the Department's proposal to require immunization against pertussis. The March of Dimes stated that pertussis is a very contagious bacterial disease that invades the upper respiratory system and releases toxins, which cause airways to swell. The disease is very contagious, and is spread by coughing or sneezing, or by spending time in close proximity to another person. According to the March of Dimes, many babies who get pertussis are infected by older siblings, parents or caregivers who are unaware they have the disease. According to the March of Dimes, infected individuals are most contagious about 2 weeks after the cough begins and the best way to prevent pertussis is to receive the vaccination.

 The Department agrees with the March of Dimes.

 One commentator stated that she supported the addition of pertussis as a required vaccination. According to the commentator, requiring a vaccine with a pertussis component is essential to slow down the increasing number of students being diagnosed with the disease. The commentator stated that the diagnosis is typically made after the child has been in school during the time of active disease transmission. Further, according to the commentator, the student often misses several days of school until a 5-day course of antibiotics is completed and suffers a prolonged recovery period of suboptimal health due to persistent cough and fatigue.

 The Department is in agreement with the commentator. The Department needs to clarify the statements it made in its preamble to the proposed rulemaking that it was adding a dose of pertussis to the required list of immunizations. In fact, this is not completely accurate. The Department added pertussis to the list of diseases against which a child shall be immunized before entering and attending school in acknowledgment of the fact that single antigen diphtheria, single antigen tetanus and single antigen pertussis vaccine are not available in the United States. Children being immunized against diphtheria and tetanus in this Commonwealth prior to this final-form rulemaking are receiving DTaP, in accordance with ACIP recommendations (unless the child had a contraindication for the pertussis vaccine or a religious/philosophical exemption) and are already receiving a pertussis component in their vaccination. There is also a pertussis component in Tdap, which the Department currently requires for entry into the 7th grade. See § 23.83(c)(1). Because of the recent outbreaks of pertussis, the Department found the addition of pertussis to the list of diseases to ensure vaccination to be appropriate. A child who has contraindications to the pertussis immunization may, as indicated in the regulation, receive the less widely available DT vaccination to complete the series.

 One commentator asked why the Department includes tetanus vaccine in its list of immunizations, when it is not a communicable disease.

 The requirement that children be immunized against tetanus is already in place under § 23.83(b) and is not impacted by this final-form rulemaking. In fact, tetanus is a communicable disease, as defined by the Disease Prevention and Control Law of 1955. A ''communicable disease'' is defined in section 2 of the Disease Prevention and Control Law of 1955 (35 P.S. § 521.2) as ''[a]n illness due to an infectious agent or its toxic products which is transmitted, directly or indirectly, to a well person from an infected person, animal or arthropod, or through the agency of an intermediate host, vector [or] the inanimate environment.'' The Department and the Board have the authority under the section 16(a)(6) of the Disease Prevention and Control Law of 1955 to ''issue rules and regulations with regard to. . .the immunization and vaccination of persons. . . ,'' as well as to create a list of diseases against which a child shall be immunized to enter school under section 1303(a) of the Public School Code of 1949, and to make and revise a list of communicable diseases against which children are required to be immunized against as a condition of attendance at a public, private or parochial school under section 2111(c.1) of The Administrative Code of 1929. Therefore, the Department, with the approval of the Board, has the authority to include tetanus on the list. Tetanus is a disease that is often fatal and can result from a small puncture wound or an animal bite. Often times there is no history of injury. From 2001—2008, the last years for which data was compiled, the case fatality rate was 13%. Pink Book, p. 345. This can vary depending on whether experienced intensive care unit personnel and resources are available. Once contracted, tetanus is extremely difficult to treat. Because it is characterized by painful muscular contractions, first of the jaw and neck, and then of the trunk, there is the possibility that the child would be hospitalized and on a ventilator for some time. A full recovery without lasting effects is not assured. Control of Communicable Disease Manual, p. 529. ACIP recommends the immunization, and the Department has not seen a reason to remove it from the list, despite the fact that it is not spread through human-to-human contact. The efficacy rate of tetanus vaccination is 100%. Pink Book, p. 347.

 One commentator recommended the addition of a requirement allowing for parental confirmation of pertussis, since the commentator knew a school-aged child who had had pertussis, and the vaccination would be pointless for him.

 The Department disagrees with this recommendation, and has not revised this final-form rulemaking. Diagnosis of pertussis can be difficult to confirm, particularly with tests other than a culture for B. pertussis. Kretsinger, MD, K., et al. (2006), ''Preventing Tetanus, Diphtheria, and Pertussis Among Adults: Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and Recommendation of ACIP, Supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for Use of Tdap Among Health-Care Personnel,'' MMWR, 55(RR 17), retrieved from http://www.cdc.gov/mmwr/pdf/rr/rr5517.pdf. Further, vaccination with Tdap for children with a history of pertussis disease is recommended, because the duration of the protection by pertussis is unknown. Pink Book, p. 271.

 Multiple commentators, including PACIC, opposed the inclusion of a pertussis vaccination. PACIC stated that it was not effective, and did not add to herd immunity, according to a 2013 study. The commentators stated that given the fact that the CDC and top doctors are verifying that the vaccine lacks efficacy and there is early waning of immunity from the vaccine, it is hasty to add a vaccine that is already under scrutiny from the medical community. PACIC and another commentator cited the FDA as stating the vaccine does not prevent transmission of pertussis. The other commentator quoted the CDC as saying that despite high levels of vaccination pertussis outbreaks continue to occur, and as reporting no school-aged deaths from 2012 to 2014. The deaths were in children younger than 3 months of age. The commentator stated that since the vaccine comes with severe risks of adverse effects up to and including death, the benefits must be weighed against the risks. One of these commentators noted outbreaks of pertussis among fully vaccinated. Several commentators cited a February 2016 AAP publication that stated Tdap provided moderate defense against pertussis during the first year of vaccination but not much longer, immunity waned in the second year and little protection remained after 2 to 3 years. One commentator cited the period as from 2 to 4 years, another as 2 to 5 years. One commentator stated that immunization might prevent clinical symptoms, but could not block infection, carriage or transmission. The commentator stated that people who get four to six vaccinations can get silently infected and transmit infection without any symptoms, showing the illusory nature of vaccine acquired herd immunity.

 One commentator stated that she had personally studied the CDC, FDA, the National Institutes of Health and other scientific documents concerning this particular vaccine showing that historically and presently it has been and is a complete failure since its inception. The commentator has watched the rate of pertussis skyrocket since 2005 when ACIP gave a recommendation for pregnant and post-partum women to receive this vaccine, despite the fact that the majority of physicians' opinions are that the safety of this practice had not and still has not been established. The commentator stated that pregnant women are being experimented on without their knowledge. The commentator stated that the vaccine manufacturers clearly state in all their brochures that the pertussis vaccine does not prevent the carrying or transmitting of pertussis. According to the commentator, it simply potentially decreases an individual's symptoms to that of a common cold or the flu allowing them to further perpetuate the disease unknowingly with extensively delayed diagnosis and treatment of antibiotics. The commentator stated that ACIP also found indicators that when the mother has received Tdap, it lessened the potential benefit of pertussis vaccine in their children due to cellular changes. The commentator stated that Bordetella pertussis has a long history of outsmarting the vaccine industry by RNA changes and mutation. The commentator stated also that there are 32 different strains of Bordetella all with similar signs and symptoms and that makes it difficult to diagnose the particular disease.

 The Department disagrees with the commentators and has not revised this final-form rulemaking. Although there have been breakthrough pertussis outbreaks, the response of the CDC and AAP has been to recommend booster vaccines and other vaccination strategies, not to recommend no vaccination. See ''FDA Approval of Expanded Age Indication for a Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine'' (FDA Approval of Expanded Age Indication), MMWR, 60(37) (2011), 1279-1280, retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6037a3.htm; and American Academy of Pediatrics (2011), ''AAP Updates TDAP Recommendations,'' retrieved from https://www.aap.org/en-us/about-the-aap/aap-press-room/pages/AAP-Updates-TDAP-recommendations.aspx.

 Even if there is some waning of immunity from the vaccine, there is still also some protection being afforded by it. Several studies of outbreaks have noted that those who refused pertussis immunizations were at greater risk for contracting the disease than those who had the immunization. See ''Parental Refusal of Pertussis Vaccination'' and ''Pertussis Epidemic,'' p. 4 (''[u]nvaccinated children have at least an eightfold greater risk for pertussis than children fully vaccinated with DTaP.''). In addition, pertussis vaccine is already present in DTaP, which is recommended by ACIP for vaccination against diphtheria and tetanus, which has been on the list of diseases against which children shall be immunized to enter and attend school in this Commonwealth. See former § 23.83(b)(1) and (2). It is also a component of Tdap, which has been required for entry into the 7th grade since 2011. See former § 23.83(c)(1)(i). The Department has also taken into account the need to address possible pertussis vaccine contraindications, and has allowed for a child to have DT to complete the vaccination series. See final-form § 23.83(b)(1). A parent may also obtain a medical or religious exemption for a child. See § 23.84 (relating to exemption from immunization).

 Multiple commentators opposed the inclusion of pertussis vaccine for kindergarten. One commentator stated that she had a very severe reaction to the DTaP vaccine as an adult, when her child was born, and it has changed her and left her the shell of a person she used to be. She stated that she is only starting to regain her health 7 years later. She stated that every case of pertussis she sees in the area is in fully vaccinated children, which leads her to believe there is a problem with the vaccine, not the unvaccinated children. The commentator stated that she is coming from a place of wanting informed decisions made for her family between her doctor and herself. One commentator stated that he had a friend whose child received the vaccination only to be infected with whooping cough. The commentator said that 40 years ago a child was asked to stay home for 5 days of school. He asked when was the last time there was a whooping cough outbreak among the nonvaccinated. There has not been one in this Commonwealth to his knowledge. One commentator stated that she opposes vaccinating her child again with the vaccine for kindergarten admission. She stated that her child had the vaccine and still had to undergo whooping cough testing, so not only did her child have to undergo vaccination, but also the testing, which was equally painful. One commentator stated that they are the parents of a child who had a severe reaction to the shot and needed two brain surgeries which they believe were related to the vaccine side effect. The commentators believed that a parent has the right to consider family history and predisposition to negative reactions and reject it if they choose.

 One commentator's son, on receiving the first of diptheria, pertussis and tetanus (DPT) as an infant, reacted within hours with inconsolable crying. The commentator stated that a State health department worker recommended not giving the remaining doses of DPT. The commentator stated that not all children can receive all vaccines.

 The Department agrees that not all children can receive all vaccines. In fact, if a child has a medical contraindication, there is a medical exemption available. Further, in a case where it appears there may be a medical contraindication to the pertussis component of the vaccine, the regulation provides for the completion of the series with DT, which does not include a pertussis component. See § 23.83(b)(1).

 One commentator quoted Tetyana Obukhanych, an immunologist, as stating that the introduction of the acellular pertussis vaccine in the late 1990s was followed by an unprecedented resurgence of whooping cough. She quotes her as further stating that an experiment with deliberate pertussis infection in primates revealed that the acellular pertussis vaccine is not capable of preventing colonization and transmission of B. pertussis, citing a study in 2015 for the finding that acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model. The FDA issued a warning regarding this crucial finding. The commentator further cited the 2013 meeting of the Board of Scientific Counselors at the CDC as revealing additional alarming data that pertussis variants currently circulating in the United States acquired a selective advantage to infect those who are up to date for the DTaP boosters, meaning that people who are up to date are more likely to be infected, and thus contagious, than people who are not vaccinated. The commentator stated that it did not make sense for the Department to require more doses of a problematic vaccine. The commentator stated that this would place an undue burden on those who might react with no benefit to them or anyone else.

 Another commentator stated that there is much scrutiny with the pertussis vaccine, that the first pertussis vaccine did not work and the second one has mutated. The commentator stated that the outbreaks of pertussis are all persons vaccinated with the newer vaccine. The commentator stated that due to the mutation of the virus, it has become more virulent and people who get the disease are getting sicker than people in previous outbreaks. The commentator believed it would be irresponsible to force another skeptical vaccine on innocent children especially when it is another mixed vaccine like Tdap. The commentator stated parents and grandparents must insist on vaccines that are properly tested for longer periods of time by independent organizations, and that overloads of mixed vaccines are not forced on infants and children. The commentator stated that the testing is done by the vaccine manufacturers who are not liable or accountable for safety or efficacy.

 The commentator went on to state that according to VAERS, there have been more than 21,014 reports of serious adverse reactions associated with pertussis-containing vaccines, with the vast majority, 15,535, in children under 3 years of age. According to the commentator, 93% of the 2,628 deaths reported in association with pertussis-containing vaccines are also in children under 3 years of age. Requiring an additional dose for children entering kindergarten may result in an increase in deaths for that age group and, since the vaccine does not prevent the disease, there would be no benefit to balance the risk.

 The commentator stated that not every vaccine works as well as advertised, and that some can do irreparable harm. The commentator stated that more and more catastrophic reactions are being reported, and that there are increasing reports of vaccine failure, such as the recent outbreak of mumps, which was tied not to the failure of the herd to vaccinate, but to manufacturer fraud. The commentator stated that the knee-jerk response of requiring more and more vaccines and tying the right to attend to school to more and more vaccines is not the answer.

 One commentator stated that it has been proven that pertussis is often spread by persons that are recently vaccinated, and until more studies are done, and it can be determined how and why this is happening, or an alternative is developed that is safer, it should not be mandated. The commentator stated that parents should be able to choose between Td and Tdap.

 The Department disagrees with the commentators and has not revised this final-form rulemaking based on the comments. As the Department has explained, many students are already being immunized against pertussis at school entry and for attendance due to the fact that single antigen diphtheria, tetanus and pertussis vaccines are not available in the United States. In addition, ACIP recommends vaccination of children with an acellular pertussis vaccine. ''Pertussis Vaccination: Use of Acellular Pertussis Vaccines Among Infants and Young Children: Recommendations of the Advisory Committee on Immunization Practices (ACIP)'' (Use of Acellular Pertussis Vaccines), MMWR, 46(RR 7) (1997), 1—25. The AAP also recommends vaccination against diphtheria, tetanus and pertussis. See American Academy of Pediatrics (2015), ''DTaP Vaccine: What You Need to Know (VIS),'' retrieved from https://www.healthychildren.org/English/safety-prevention/immunizations/Pages/diphtheria-Tetanus-Pertussis-Vaccines-What-You-Need-to-Know.aspx.

 Children in this Commonwealth are being immunized with DTaP to attend school. The SILR data shows that this is occurring because schools are providing the Department with information on the number of students being vaccinated with DTaP and Tdap in kindergarten and 7th grade. See School Level Data for 2014 and 2015 included in the RAF for this final-form rulemaking. The Department acknowledges that no vaccine is completely safe, and that adverse effects do occur. ACIP recommended the use of DTaP and the FDA licensed it, taking safety issues into consideration. See generally ''Use of Acellular Pertussis Vaccines.'' The Department, and the Board, are following ACIP's recommendations. If the pertussis antigen is contraindicated for a child, as contraindications are described by ACIP (Pink Book, p. 274), or if a practitioner giving the vaccination believes there is a contraindication, the child has the option of receiving DT to complete the series (see final-form § 23.83(b)(1)), or if the child would be receiving Tdap (see final-form § 23.83(c)(1)(i)).

 In addition, the waning of pertussis immunity among vaccinated and unvaccinated individuals has been documented. However, ACIP and AAP have recommended booster vaccines, not the elimination of the vaccine requirement. As with any vaccine, there are known adverse effects. A more effective vaccine, which contained whole cell pertussis vaccine, was disfavored because of potential health issues, and acellular pertussis vaccines were developed. ''Use of Acellular Pertussis Vaccines,'' p. 1. The Department is aware that not every vaccine is 100% effective, but, as studies have shown, vaccinated children have a less virulent form of the disease and are less likely to contract it. See ''Parental Refusal of Pertussis Vaccination'' and ''Pertussis Epidemic,'' p. 4 (''[u]nvaccinated children have at least an eightfold greater risk for pertussis than children fully vaccinated with DTaP.'').

 According to ACIP, in studies it considered in recommending the Tdap vaccination, pertussis disease has three phases, catarrhal, which is characterized by an intermittent cough and coryza, which lasts 1 to 2 weeks; a paroxysmal phase: characterized by spasmodic cough, posttussive vomiting and an inspiratory whoop, which lasts 4 to 6 weeks; and a convalescent phase, during which symptoms slowly improve, but which can last months. Broder, MD, K. R., et al. (2006), ''Preventing Tetanus, Diphtheria, and Pertussis Among Adolescents: Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP)'' (Preventing Tetanus, Diphtheria, and Pertussis), MMWR, 55(RR 3), 1—34, retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5503a1.htm. Complications during the illness include hypoxia, pneumonia, seizures, weight loss, encephalopathy and death. See ''Preventing Tetanus, Diphtheria, and Pertussis.'' The Department and the Board, relying on ACIP's and AAP's recommendations, and the FDA's licensure of the vaccine, determined to include pertussis in the list of diseases against which children shall be immunized. The Department notes, again, that a parent or guardian has recourse to the medical and religious/philosophical exemptions if the child qualifies for those exemptions.

 With respect to the comment that a parent should be able to choose between Tdap and Td, the Department notes that Tdap is already a required vaccination. Nothing in this final-form rulemaking changes that requirement. If a child has a contraindication for pertussis, the response for entry into 7th grade would be to obtain a medical exemption, not to vaccinate the child with an additional diphtheria and tetanus combination. The Department added Tdap to the list of immunizations required for entry into 7th grade in 2011 to account for the waning pertussis immunity being seen across the United States. See 40 Pa.B. 2747.

 One commentator stated that the current outbreak of pertussis among fully vaccinated and up-to-date children suggests real challenges for vaccine manufacturers, particularly in regard to the efficacy of vaccines containing pertussis bacteria. The commentator suggested that the inefficacy of the vaccine merits a cessation of any new regulation, and respect for parents who wish to preemptively condition their child for pertussis immunity by homeoprophylaxis or homeopathic ''vaccination,'' as studied and directed by Dr. Isaac Golden, PhD (MA), D.Hom. N.D., B.Ec (Hon), Australia.

 The Department disagrees with the commentator. In promulgating this final-form rulemaking, the Department notes that it, with the approval of the Board, is following the recommendations of ACIP and in agreement with the recommendations of AAP. The Department notes that a parent or guardian has recourse to the medical and religious/philosophical exemptions to if their child qualifies for those exemptions.

 PACIC stated that pertussis should not be included in a combination vaccination because it is highly possible that the vaccine type or procedure used may be altered in the near future, and combining it with tetanus and diphtheria antigens in one paragraph will make future changes more difficult while creating no notable benefit now.

 The Department has not revised this final-form rulemaking. The Department notes that there is no single antigen pertussis vaccine available. ''Preventing Tetanus, Diphtheria, and Pertussis,'' p. 2. Pertussis vaccine is only available as part of DTaP or Tdap vaccines, and so cannot be listed separately. Any child with a possible contraindication to the pertussis vaccine can, as permitted by the regulation, finish the series with DT; in the case of the Tdap requirement or if the child's physician or physician's designee finds it to be appropriate, the child may obtain a medical exemption.

§ 23.83(b)(2)—Poliomyelitis

 Multiple commentators recommended that the Department change final-form § 23.83(b)(2) from ''enhanced activated polio vaccine'' to ''enhanced inactivated'' polio vaccine. One commentator stated that the existing polio vaccine is being phased out, and there are numerous complications from polio vaccines, from causing polio to SV40 related cancers and mutations. Another commentator stated that problems with the polio vaccine have required a massive effort to destroy all vials of it. The commentators stated that this is a reason why caution should be exercised in adding new vaccines to the schedule.

 The Department revised ''enhanced activated polio vaccine'' to ''inactivated polio vaccine'' in final-form § 23.83(b)(2). This accords with ACIP recommendations in July 1999 that inactivated polio vaccine be used exclusively in the United States, beginning in 2000. Pink Book, p. 304. Exclusive use of inactivated polio vaccine in the United States eliminated the shedding of live vaccine virus, which was responsible for vaccine-associate paralytic polio. Pink Book, p. 301 and 302. ''Exclusive use of [inactivated polio vaccine] eliminated the shedding of live vaccine virus, and eliminated any indigenous VAPP.'' Pink Book, p. 304. The Department notes that the near eradication of polio in the last century was one of the greatest achievements in public health.

 One commentator stated that a fourth polio dose is unnecessary.

 The Department disagrees with the commentator and has not revised this final-form rulemaking. The Department notes that former § 23.83(b)(3) regarding polio stated that three or more doses were required. Specifying four doses in this final-form rulemaking clarifies the regulation.

 PACIC stated that the Department stated that polio had not been eradicated, but that while this was true globally, it has been eliminated in the United States.

 The Department agrees that polio has been eliminated in the United States. The Department notes that this is attributable to the introduction of the polio vaccine in the United States. Polio still exists in other countries like Afghanistan, Pakistan and Nigeria, where efforts to eradicate it have been stymied by the killing of persons trying to provide vaccines to the population. BBC (2016), ''Pakistan Polio: Seven Killed in Anti-vaccination Attack,'' retrieved from http://www.bbc.com/news/world-asia-36090891; see also Scales, D. (2013), ''At Least Nine Polio Workers Killed in Nigeria,'' The Disease Daily, retrieved from http://www.healthmap.org/site/diseasedaily/article/least-nine-polio-workers-killed-nigeria-21113. The possibility of a case coming to the United States cannot be discounted.

§ 23.83(b)(3)(iii)—Evidence of immunity (for measles, mumps, rubella)

 IRRC commented that the Department's use of ''nurse practitioner'' and ''physician's assistant'' were inaccurate, since the first was not sufficiently specific to detail what type of a practitioner was intended and the second was an inaccurate use of the term. IRRC noted the appropriate term should be ''physician assistants'' not ''physician's assistant.''

 The Department revised § 23.83(b)(3)(iii) to more specifically refer to a ''certified registered nurse practitioner'' and to use the correct term ''physician assistant.''

§ 23.83(b)(5)(ii)—Evidence of immunity for varicella (chickenpox)

 The Department received many comments opposing the proposed amendment to the proof of immunization requirements for varicella.

 Several commentators misunderstood the Department's intentions regarding the regulation. One commentator opposed the proposed amendment to immunize for chickenpox. The commentator stated that she thought this requirement was bogus, and that it should be her right to vaccinate her child as she sees fit. She stated that there is no data that having the varicella vaccine wards off having shingles in later years. She stated that there are more cases of flu than of chickenpox on a yearly basis, and that she is sure more people die from flu than chickenpox.

 One commentator stated that while she is not opposed to other vaccinations, she is ethically opposed to the varicella vaccination.

 HSLDA and one other commentator stated that children who have had chickenpox should not be required to obtain the vaccine because they have natural immunity.

 The commentators were confused as to the proposed amendment to the regulation. Varicella immunization has been a required immunization since 2001. See 31 Pa.B. 5525 (September 29, 2001). The Department did not intend to require children who have already had the disease to be revaccinated. The Department proposed to amend the proof of immunity provision that allowed a parent to provide a history of varicella disease as proof of immunity with language that would only permit a history of disease from a physician, CRNP or PA. This is in accordance with ACIP recommendations. Marin, MD, M., et al. (2007), ''Prevention of Varicella: Recommendations of the Advisory Committee on Immunization Practices (ACIP),'' MMWR, 56(RR 4), 1—40, retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5604a1.htm. The amendment was recommended because it is difficult to determine whether a rash is in fact chickenpox, and the Department is concerned that a child actually be immune, in part so that the child is not at risk in the event of an outbreak. After reviewing other comments, the Department decided to keep the parental history requirement in place as previously discussed. In originally proposing the amendment, the Department was following CDC recommendations through its advisory body, ACIP, and was merely concerned with ensuring that children with rashes have really had chickenpox, and are thus actually immune. It is difficult for a nonclinical individual, even a parent, to definitively identify the etiology of any rash.

 PASA and two other commentators agreed with the Department's requirement that a history be provided by a physician, CRNP or PA. One commentator stated that parents are not able to determine with any validity whether a particular combination of symptoms and rash is an actual case of varicella.

 The Department thanks the commentators for the support, and agrees that it is difficult for a nonclinical individual to definitively identify the etiology of any rash. The Department is not adopting the proposed deletion and will allow the submission of a parental history of disease to continue to stand as proof of immunity for varicella. In the proposed rulemaking, the Department proposed to adopt ACIP recommendations and amend the existing regulation to require a history of disease from a doctor, PA or CRNP, rather than a parent or guardian. The Department proposed this amendment because, particularly with diseases involving rashes, it is difficult for anyone to make a definitive identification of the disease, and because it is more likely that a doctor, CRNP or PA, for whom either diagnosis or examination is within the scope of practice, and with clinical experience, can more accurately identify a particular rash.

 After reviewing comments regarding cost to parents and guardians and time constraints on them, the Department rethought that requirement. The Department still believes that the most effective method of determining actual immunity, other than from history of the vaccination, is to require a history from a doctor, CRNP or PA. The Department decided not to make the proposed amendment that would have only allowed a history from those practitioners. The Department will adopt the amendment expanding the type of practitioners allowed to provide a history in addition to a physician, but making the requested changes to ''nurse practitioner'' and ''physician's assistant'' as IRRC recommended. The Department will keep the provision allowing, in the alternative, a history from the parent or guardian in § 23.83(b)(5)(ii)(B).

 The Department acknowledges that many parents and guardians may not take a child to be seen by a health care practitioner for a potential case of chickenpox, and that a health care practitioner may not wish to see the child in the office. If a physician, CRNP or PA refuses to see a child, or if a child has had the disease in the past and not seen a physician, CRNP or PA, the only way to satisfy this requirement would be by a blood test. A blood test would involve the parent or guardian in additional costs that are potentially not covered by insurance. Because of this, the Department has not adopted this proposed amendment. Parents and guardians may still provide history of disease under § 23.83(b)(5)(ii)(B).

 The Department notes that in the event of an outbreak of disease in a school, children who are listed as having immunity due to a history of disease, but are not actually immune, may create additional problems in containing the disease. They can catch the disease, be ill, and involve their parents and guardians in expenses attendant to that illness. They can also potentially continue to spread the disease unknowingly into a wider area until they become ill and are quarantined themselves. Because the universe of persons susceptible to disease cannot be known, the outbreak may be more difficult to contain.

 IRRC noted that multiple commentators stated that parents should be permitted to provide evidence since chickenpox is a mild disease that does not require medical intervention and that contagious children should not be taken into medical facilities where other children are present. IRRC noted these commentators also raised the financial burden on families. IRRC asked whether the ACIP and CDC guidelines allowed parents to diagnose varicella. If this is the case, IRRC stated that the Department should provide further support for changing this practice. IRRC stated that the Department should also explain the reasonableness of imposing new financial burdens when the existing practice is acceptable to the CDC.

 Multiple commentators stated that amending the regulation would require the child to be seen in a health care practitioner's office. The commentators stated that many practitioners do not want a child who may have chickenpox coming to the office because it would expose others in the waiting room. Multiple commentators stated that requiring the child to go to the doctor's office or to the emergency room would be a burden upon the ill child and put a financial burden on families. Several commentators, including PACIC, stated that it was irresponsible of the Department to force a child with a highly contagious disease to visit a medical facility where other children, including those who are medically fragile, will likely be present and therefore be at high risk to spread the disease. One commentator stated that normal advice was to avoid public places when a child was sick with chickenpox.

 One commentator asked whether the Department was proposing that parents parade their contagious children into a medical office to receive confirmation of chickenpox. She stated that asking for proof of immunity for a nondangerous virus was unnecessary. One commentator stated that normal advice to those with chickenpox is to avoid public places. One commentator noted that if one sibling spreads chickenpox to another, the only documentation would be parental history.

 One commentator asked where the big epidemic was that would make anyone think that parents do not know what is going on and sending their children to school to infect others. The commentator stated that the regulation would cause parents to carry the financial burden of paying for an unnecessary office visit to confirm what can be easily seen, and would increase the possibility of spreading disease.

 Many commentators stated that it appeared as if the Department did not trust parents and guardians to be honest regarding whether or not their child had had chickenpox. One commentator stated that chickenpox could be recognized by the fluid-filled itchy vesicles. Another commentator stated that her children had chickenpox when they lived outside this Commonwealth and no responsible doctor would provide her with a verification of this since over a decade had passed. She stated that this would lead to the impression to students and parents that parents cannot be trusted, and damages the bigger picture issue.

 Several commentators suggested that it was difficult for anyone to make a determination that a child had varicella. One commentator stated that she had recently cared for a child with chickenpox and strongly opposed requiring proof of natural immunity to be provided by a medical professional. The commentator stated that chickenpox misdiagnoses occur frequently and the symptoms are vague and similar to diseases such as the common flu. The commentator stated that chickenpox can be confused with other infectious diseases that cause a rash such as strep, measles and roseola. The commentator stated that a diagnosis could be overlooked because a child has already been vaccinated. The commentator asked what the purpose of a diagnosis is when a test is required to determine the disease accurately. Another commentator noted that a friend traveled to Texas and his son came down with an extreme case of hand, foot and mouth disease, which was diagnosed as chickenpox by an urgent care center in Texas. He was not able to travel home since they thought it was chickenpox.

 Many commentators stated that chickenpox was not life-threatening and children, including them, recovered without going to the doctor. One commentator stated that since parents would not be taking the child to the office, the health care provider would simply be forwarding the parent's assessment of the infection anyway.

 Several commentators stated that many parents choose not to take their child to the doctor when the child is infected by varicella, and should not be required to do so, since it is not usually the case that a child ill with chickenpox needs a physician's care. This would create an undue burden on the parent and on the doctor's office. Another commentator stated that requiring a physician, CRNP or PA to provide a history of immunity for chickenpox rather than a parent was unnecessary, and did not make allowances for a child who never went to a doctor when the child had chickenpox.

 One commentator stated that parents and medical staff did not need to be burdened with more unnecessary medical paperwork; the commentator stated that there is now a 2-week time frame for processing and a charge for the completion of the paperwork at the commentator's provider. The commentator asked the Department to think how that would affect a family with two children in school with sports, camp and school activities. The commentator stated that it was a lot of running back and forth and costs add up.

 One commentator stated that the Department's requirements were unreasonable and ignorant. She stated that clearly none of the Department staff involved in drafting the proposed rulemaking had children. She stated that if she called her child's pediatrician and asked for an appointment just because she needed documentation from a physician, they would refuse to see the child, and she would have hardships from taking time from work and having to pay the office copay.

 One commentator mentioned that chickenpox was a right-of-passage in the 1980s when she was a child. She stated that she was not aware of any children in her community, school or family seriously injured with chickenpox. She stated that children whose mothers have had chickenpox are unlikely to catch it before they are 1 year of age, because of antibodies in the mother's blood. She stated that before the vaccine, of 4 million children per year affected with the virus, only 100 deaths occurred annually. According to the commentator, unlike with the vaccine, life-long immunity is acquired through having the disease.

 Two commentators stated that when they were children, their physicians instructed their parents to have all of the siblings sleep in the same room to contract it. Two commentators stated that the disease was no worse than hoof and mouth, and that their children had contacted hoof and mouth in daycare centers. Several commentators stated that a child should not be required to receive the vaccine if the child has natural immunity. These commentators stated that a written statement from the parents should be enough evidence to state a history of immunity and should be trusted. One commentator said that it was absurd to tell a parent they could not be trusted to be honest about their child's history of chickenpox, and that it was also insulting and a financial burden to make an additional visit to the doctor's office.

 After reviewing all the comments and giving consideration to the potential costs of this requirement, the Department eliminated the proposed requirement that only physicians, CRNPs and PAs may provide history of disease, as previously discussed. The Department makes it clear in response to IRRC's comment regarding whether parents may diagnose that only certain health care practitioners are permitted, within the scope of their practice, to diagnose. The issue here was not one of diagnosis since neither the CDC nor ACIP can set rules on a practitioner's scope of practice. The issue was also not one of whether the parent or guardian is telling the truth relating to a child's history of disease. The issue was that it is extremely difficult for a lay person to see a rash and know that it is definitively one thing or another. Therefore, in outbreak cases, a child may be noted as having immunity when in fact the child does not.

 The Department acknowledges that many parents and others believe chickenpox to be a mild illness that does not necessitate a visit to a health care practitioner, and in those cases when a child has not seen a physician, CRNP or PA for the disease, there is no physician, CRNP or PA who would be capable of providing a history of disease. Because this would then require a blood test that is expensive and not covered by insurance, the Department has withdrawn the proposed amendment. The Department makes it clear that the Department does not and has never taken the position that chickenpox is simply a mild childhood disease. In the preamble to the final-form rulemaking published at 31 Pa.B. 5525 adopting varicella immunity as required for school entry and entry into the 7th grade in 2001, the Department stated:

Prior to the availability of varicella vaccine, there were approximately 4 million cases of varicella a year in the United States. It is correct that most cases are free from complications. However, although varicella is frequently perceived as a disease that does not cause serious illness, especially among healthy children, 11,000 hospitalizations and 100 deaths from complications relating to varicella occurred every year in the United States before the varicella vaccine became available. The majority of deaths and complications occurred in previously healthy individuals.

 One commentator cited these figures to show that varicella is not a disease to give concern. The Department disagrees and has always disagreed. For that reason, the Department added varicella immunity to the list of diseases against which immunity is required in 2001.

 In response to commentators' concerns that to require a child to see a physician, CRNP or PA in the office for a case of chickenpox would place a potentially infectious child in a situation to spread the disease, the Department notes that there are ways of dealing with issues of spread of disease in doctors' offices that do not put either the child or the other patients at risk.

 In addition, with respect to comments that it is insulting that the Department does not believe a parent can recognize chickenpox, or that it is easily identifiable, the Department disagrees. The proposed amendment was prompted by the fact that obtaining a history of disease from a nonmedical individual, even if the nonmedical individual is a parent, is fraught with the possibility of mistake. It is difficult to determine whether or not a rash is chickenpox simply from clinical symptoms, although a health care practitioner who deals with rashes and fevers on a daily basis, and through education and experience, has a better opportunity of making that determination.

 In response to IRRC's comment that the Department should explain the financial reasonableness of imposing a new requirement when the existing practice of accepting a parental history was acceptable to the CDC, the Department notes that ACIP, which advises the CDC regarding childhood immunizations, recommended that the criteria for evidence of varicella immunity should not include a self-reported vaccine dose or a history of vaccination provided by a parent, without more. ACIP recommended that evidence of immunity should be either a diagnosis of varicella by a health-care provider or a health-care provider verification of a history of disease rather than parental or self-reporting. ''Prevention of Varicella,'' p. 15. (''ACIP has approved criteria for evidence of immunity to varicella. Only doses of varicella vaccines for which written documentation of the date of administration is presented should be considered valid. Neither a self-reported dose nor a history of vaccination provided by a parent is, by itself, considered adequate evidence of immunity.'') The proposed amendment was recommended by an advisory group to the CDC, which does not believe that a parental history is sufficient to accurately identify those children who may be at risk for the disease.

 One commentator stated that this proposed amendment would remove the individual's right to a health system of his own choosing. The commentator stated that agencies cannot constitutionally demand or define how or through what means or entity an individual shall receive medical care.

 The proposed amendment did not attempt to tell an individual how or where to receive health care. The proposed amendment simply would have disallowed the use of a parental history of disease to prove that a child was immune to chickenpox. For other reasons, the Department decided to delete this requirement from this final-form rulemaking and leave the parental history of chickenpox in place as proof of immunity.

 PACIC asked that data be provided relating to proof of immunity. PACIC asked whether there was data showing that parents stating that their children have chickenpox is untrue. The commentator stated that there was data showing that parents are no longer capable of identifying chickenpox. Another commentator stated that if the Department was proposing this amendment because the current system was being abused, the Department should produce proof of the abuse. The commentator did not believe that there was any basis for this proposed amendment. One commentator asked whether the Department had data showing that parents were no longer capable of identifying childhood diseases such as chickenpox.

 The Department revised the regulation in this final-form rulemaking, so the request for data is moot. The Department notes that ACIP recommendation was based on the following from ''Prevention of Varicella'':

Historically, self-reporting of varicella disease by adults or by parents for their children has been considered valid evidence of immunity. The predictive value of a self-reported positive disease history was extremely high in adults in the prevaccine era although data on positive predictive value are lacking in parental reports regarding their children (131—133). As disease incidence decreases and the proportion of vaccinated persons with varicella having mild cases increases, varicella will be less readily recognized clinically. A recent study demonstrated that only 75% of unvaccinated children aged 12 months—4 years who reported a positive history of varicella were in fact immune (confirmed by serological testing), compared with 89% of children aged 5—9 years and 10—14 years (134). To limit the number of false-positive reports and ensure immunity, ACIP recommends that evidence of immunity should be either a diagnosis of varicella by a health-care provider or a health-care provider verification of a history of disease rather than parental or self-reporting.

 The Department did not intend to suggest that parents and guardians were lying about the status of their children, or that this provision was being abused. The proposed amendment was prompted by the fact that obtaining a history of disease from a nonmedical individual, even if the nonmedical individual is a parent, is fraught with the possibility of mistake. It is difficult to determine whether or not a rash is chickenpox simply from clinical symptoms, although a health care practitioner who deals with rashes and fevers on a daily basis has a better opportunity, through education and experience, of making that determination. The Department understands the cost-related issues and decided to maintain the requirement that parents be able to provide a history of disease for varicella.

 One commentator noted that in an urban high school setting with a transient population, many children do not have insurance and titers are expensive.

 The Department recognizes that titers are expensive and, factoring that into other considerations, decided against adopting the proposed amendment.

 Multiple commentators, including PACIC, stated that not all families have existing relationships with the list of specified medical workers, and this provision could force a family to enter into a contractual relationship with unknown medical staff. These commentators stated that families would have the financial burden of copays, charges and laboratory fees. Two commentators stated that this would be around $250 for two children. One commentator stated that making a trip to a medical professional and getting testing done to verify that the child has immunity is a huge cost for parents. Several commentators stated that even if the Commonwealth paid for every child to be tested, taxpayers would still be paying for this requirement through their taxes. Lastly, these commentators stated that this could create an environment of distrust between the school staff and the parents if the parents' word appeared to be questioned.

 The Department revised this final-form rulemaking after consideration of the potential costs of the requirement. In response to the commentators' concerns, although the Department is aware that there are families without primary care providers, that is, the list of medical staff referenced by the commentator, the passage of the ACA, which requires all persons to be insured, gives more families the opportunity to be connected to a medical home, since for most insurance plans, a primary care provider is required and can be assigned. For families who lack insurance coverage, and are uninsured or underinsured, the Department, through its VFC providers, can provide the vaccine, which may be necessary if there is no provider to sign the history of immunity. The Department suggests that if a child does not have a medical home, being forced to find one may not be catastrophic in terms of the child's general health and wellbeing.

 One commentator stated that her daughter had caught a mild case of chickenpox from the vaccine that was supposed to protect her. The commentator stated that she wanted to bring the child into the doctor's office because she had a serious upper respiratory infection along with the mild case of pox on her body. The commentator stated that the doctor would not allow her to bring the child in because the child was contagious. The commentator noted that this was interesting—she could not bring the child in to get medical confirmation. The commentator stated that for the next 10 years she had to fight every time someone wanted to make her child have a chickenpox booster, because a child does not need a booster if the child had the disease, and she could not prove that the child had the disease. She stated that when it was time for college, she had to prove the child had the disease, and this was very expensive. The commentator stated that this remains a problem. According to the commentator, the child will be unable to obtain a proof of immunity from a medical professional, so the child will either have to be revaccinated or pay for titer testing. The commentator asked that the Department not allow or encourage the pharmaceutical industry to push its agenda of money making vaccines on the general public by forcing parents to expose their children to unnecessary and unsafe numbers of vaccines because parents or guardians cannot afford to have titers done.

 The Department understands the commentator's frustration with her health care practitioner, but cannot comment on the reasons for which that practitioner may or may not have chosen to see her child. The Department has chosen not to amend the regulation. With respect to the commentator's comments regarding the pharmaceutical industry, the Department has no control over that industry, and cannot either allow or encourage it to do anything.

 The Department notes, further, that it cannot fix the commentator's problem of having to prove immunity of varicella for college entry or retake the vaccination. This will continue to occur in those colleges that choose not to accept a history of immunity from a parent or guardian. The Department has no control over what requirements a college or university might have, and although the possible expense of obtaining a history of varicella disease from a physician, CRNP or PA or obtaining a blood test to prove immunity will now be avoided in elementary or secondary school, since the Department is not amending the regulation, it is possible that, like the commentator, a parent or guardian may have to incur the expense of a blood test or a visit to the physician, CRNP or PA prior to admission to a college or university.

 One commentator asked when the elimination of the ability to accept a parental history of varicella would go into effect.

 This requirement will not go into effect, since the Department revised the regulation to maintain the requirement that a parent may give a history of disease as proof of immunity for varicella.

 PSEA recommended that the Department create an educational campaign for providers and parents regarding the requirement that a history of disease can only be obtained from a physician, CRNP or PA.

 The Department revised the regulation so that no education on this point will be required.

 HSLDA stated that this requirement was not recommended by the Joint State Government Commission's report. HSLDA stated that varicella vaccine rates already meet Healthy People 2020 target vaccination rates.

 The Department has not adopted the proposed amendment this regulation. The Department would like to point out that while the Department appreciates that the Joint State Government Commission's report did not include the language in the Department's proposal, ACIP, made up of vaccine experts from throughout the country, did. See ''Prevention of Varicella.'' In addition, the Department is pleased that varicella vaccine rates meet the Healthy People 2020 target vaccination rates. However, the proposed amendment was not to improve rates. The Department revised the regulations to ensure that if and when an outbreak occurs, children who are presumed to be immune actually are immune.

§ 23.83(c)—Special requirements for tetanus and diphtheria toxoids and acellular pertussis vaccine and meningococcal conjugate vaccine

 The Department received multiple comments regarding the Tdap vaccine and the MCV vaccine required for entry into the 7th grade. The Department has not substantively amended the regulation, and addresses those comments as follows. The Department did make nonsubstantive changes to subsection (c), including in the heading of the subsection and in paragraph (1)(i) to correct references to the Tdap vaccine. Both diphtheria and tetanus toxoids are included in Tdap, and therefore ''tetanus and diphtheria toxoid'' has been amended to ''tetanus and diphtheria toxoids.'' The Department also added ''conjugate'' to the heading of this subsection to clarify that the type of meningococcal vaccine being added in paragraph (2) is MCV, as has been required for entry into the 7th grade since 2011. See 40 Pa.B. 2747.

 The March of Dimes supported the addition of the pertussis vaccine and the addition of a second meningitis vaccine before entry into 12th grade. According to the March of Dimes, meningococcal disease can result in permanent disability or death. The March of Dimes cited the CDC as stating that about 1,000 to 1,200 people get meningococcal disease each year in the United States, and even when they are treated with antibiotics, 10%—15% of these people die. The March of Dimes further cited the CDC as stating that of those who live, 11%—19% lose their arms or legs, have problems with their nervous systems, become deaf, or suffer seizures or stroke. The March of Dimes stated that there is a vaccine to immunize children and young adults that covers four of the five major causes of bacterial meningitis and the vaccine is readily available. The March of Dimes stated that the CDC recommends routine administration of this vaccine at 11 or 12 years of age, with a booster shot at 16 years of age.

 The Department agrees with the March of Dimes, although it notes as discussed as follows that diphtheria and tetanus toxoids and acellular pertussis vaccine have been required for entry into the 7th grade since 2011. See 40 Pa.B. 2747.

 One commentator stated that requiring a combination form of MCV and Tdap was a decision that placed children at risk. The commentator stated that if the requirement was adopted, children who received separate forms of these immunizations would be required to be revaccinated, not for any medical reason, but to comply with a nonsensical regulation that did not recognize their immunization status. The commentator stated that this placed children at risk if they needed separate antigen vaccinations for their health, and pitted their health against their education.

 The Department disagrees with the commentator. The commentator incorrectly read the proposed rulemaking. The Department is requiring combination forms of these vaccinations going forward, but will not require revaccination of children who are already immunized. As the Department has noted, there is no single antigen pertussis vaccine licensed in the United States. ''Preventing Tetanus, Diphtheria, and Pertussis,'' p. 3. Tdap was added by the Department in 2011 to provide a booster dose of pertussis, in accordance with ACIP recommendations. See 40 Pa.B. 2747. In the event a child has a medical contraindication to the pertussis vaccine, the child may obtain a medical exemption for the 7th grade Tdap requirement. With respect to MCV, the Department deleted any reference to either the single antigen form or combination form, and is simply requiring the vaccine.

 Several commentators opposed adding Tdap for 7th graders. Two commentators stated that the B. pertussis microbe has evolved to evade both whole cell and acellular pertussis vaccines in creating new strains that produce more toxin to suppress immune function and cause more serious disease. According to the commentators, immunity wanes and millions of fully vaccinated children and adults are silently infected with pertussis every year. The commentators stated that children show few or no symptoms but spread pertussis to unvaccinated and vaccinated children without doctors reporting the cases. The commentators quoted the July 2015 issue of Pediatrics as stating that lack of long-term protection after vaccination is likely contributing to increases in pertussis among adolescents. The commentators suggested that parents that wanted their children to have the vaccine could get it without the Department requiring the immunization.

 One commentator stated that section 18 of the RAF fails to discuss the fact that vaccines are drugs, and therefore carry an inherent risk of injury and death, and opposed the requirement that Tdap be required in the 7th grade. She stated that even after six doses of Tdap, vaccine effectiveness declined to 34% after 2 to 4 years, likely contributing to increases in pertussis among adolescents. The commentator also stated that bundling diphtheria and pertussis with tetanus gives students unnecessary doses of vaccines for diseases they are unlikely to catch. Tetanus is not a communicable disease, and diphtheria is extremely rare in the United States.

 The commentators misunderstand the purpose of the amendment to this subsection. The Department is not adding Tdap for 7th graders. Tdap has been required for entry into the 7th grade by the regulations since 2011. See former subsection (c)(1) and 40 Pa.B. 2747. Under the previous regulation, Tdap could be administered as a single antigen vaccine or in a combination form. Because single antigen vaccinations are no longer available in the United States, the Department amended the regulation to require a dose of Tdap in combination form only. The combination form did and still does include a pertussis vaccine component. Pertussis vaccine and the importance of tetanus vaccine are discussed previously in this preamble. In addition, to eliminate both tetanus and diphtheria from the list of diseases against which children shall be vaccinated, the Department would have to propose a separate rulemaking, and the Department has no intention of taking that action.

 PACIC stated that contraindications for pertussis vaccine are listed with the pertussis requirement for school entry, but not for the newly proposed 7th grade Tdap requirement. IRRC also recommended that the Department include a similar exception regarding contraindications for pertussis in subsection (c)(1)(i).

 As the Department has stated, the requirement for Tdap is not new, but was added to the required list in 2011. See 40 Pa.B. 2747. The Department has merely amended the requirement that the vaccine could be given in single antigen forms to a requirement that the vaccine be given in the combination form because there is no single antigen form of pertussis vaccine licensed in the United States. ''Preventing Tetanus, Diphtheria, and Pertussis,'' p. 3. PACIC is correct that ACIP recommends that the DTaP series to be completed with DT (a combination form vaccine) if there is a contraindication to the pertussis component. This provides immunity from diphtheria and tetanus, even if pertussis is contraindicated. There is no similar recommendation relating to Tdap if there is a contraindication for the pertussis component because Tdap was added for 7th grade entry in 2011 to address the need for additional pertussis immunity. The appropriate response would be for the child's physician or the physician's designee to provide a medical exemption for the Tdap dose. The Department has not amended the regulation.

 One commentator recommended that the Department work with vaccine manufacturers to produce single antigen vaccines.

 The Department does not work with vaccine manufacturers to discuss production of vaccinations.

 IRRC also noted that commentators said that some doctors will not provide vaccine to children at the 6th grade physical if the child is not 12 years of age at the time of the physical. IRRC recommended that the Department ensure that the implementation of the requirement is clear for the regulated community.

 Two commentators asked what the Department's advice would be in the event a pediatrician chooses to wait to vaccinate a child until the 12 years of age well child examination. This may not be scheduled, for insurance purposes, until after the beginning of 7th grade.

 Another commentator stated that a large pediatric practice in her area would not give Menactra (a meningococcal vaccine) until the student was 12 years of age, so that if the child was not 12 years of age at the time of the 6th grade physical, the practice would not give the vaccine. The commentator stated that the physician would tell the parents that the child is up to date, even though the child is not up to date with respect to the school immunization requirements. The commentator asked that the Department tie the meningococcal immunization requirement to the requirement that a child have a physical in the 6th grade, because having the two together might help with the compliance of both requirements.

 Another commentator pointed out that getting 7th graders up to date on immunizations is a school nurse's greatest challenge. The commentator also pointed out that 6th grade students are required by the Commonwealth to have a physical examination. She stated that many of these children are only 11 years of age at the time they get this physical, and although they can get Tdap at this time, they are not eligible for MCV until they are 12 years of age. Because of this, the student gets the physical, but gets neither the Tdap vaccine nor the MCV because the thought is the student will get both vaccines together. According to the commentator, because the next required examination in 7th grade is a dental examination, the child often gets neither vaccine because the family does not want to return to the physician's office and pay an additional fee just to get these immunizations. She recommended that the Department switch the dental and the physical examination so that the dental examination is required in 6th grade and the physical in 7th grade.

 One commentator stated that if Tdap and MCV are required for entry into 7th grade without a provisional enrollment period, then the Department should write the regulation to require these immunizations by May 1 of the year the child is in 6th grade. According to the commentator, it would be easier to encourage parents to get the child immunized with the 6th grade physical and school nurses would have additional time to notify parents and exclude students if that became necessary.

 The Department has not amended the regulation. The Department believes, in response to IRRC's comment, that the implementation of the requirement is clear for the regulated community, which only tangentially includes health care practitioners. The Department does not have the authority to regulate the practice decisions made by a licensed health care practitioner. The Department and the Board are following ACIP recommendations in setting these vaccine requirements. ACIP recommendations allow for adolescents at 11 years of age through 18 years of age, depending on previous vaccine history, to receive one dose of Tdap instead of tetanus or diphtheria toxoids ''preferably at a preventative-care visit at age 11 or 12 years.'' See ''FDA Approval of Expanded Age Indication.'' ACIP recommends routine administration of a meningococcal vaccine for all persons 11 through 18 years of age. See ''Prevention and Control (2013),'' p. 14. If a practitioner chooses to wait until the 12 years of age well child examination to provide either the Tdap or MCV immunization, or both, and that occurs after entry into the 7th grade, it may be necessary for the physician or a designee to provide a medical exemption for that particular period of time until the physician believes the immunization may be safely given. Nothing in the recommendations from ACIP or in the regulations require the vaccines to be given in an unsafe or a medically inappropriate manner.

 In addition, school nurses may start to encourage children and parents to obtain the required immunizations at any time. If the Department moved the requirement up 6 months, from the start of 7th grade to the end of 6th grade, a child could potentially be excluded at the end of a school year, raising questions of the child's promotion to the next grade.

 Further, the requirements regarding school health examinations are beyond the scope of this final-form rulemaking, which are promulgated, in part, under the Department's authority, with the approval of the Board, to set out a list of diseases against which children shall be immunized to attend or enter school. See section 1303(a) of the Public School Code of 1949, section 16(a)(6) and (b) of the Disease Prevention and Control Law of 1955 and section 2111(c.1) of The Administrative Code of 1929.

 One commentator asked whether, given the Department's statement that pertussis was only being added by requiring a combination vaccine that included that antigen, Tdap should be considered to be part of a multidose series vaccination. The commentator asked whether the Department's statement in the preamble of the proposed rulemaking that it was adding pertussis toxoid to an ''existing vaccination requirement, that of diphtheria and pertussis'' was a mistake.

 The commentator was correct that the Department's statement was a mistake, and ''tetanus'' should be read for ''pertussis'' in the quoted text. With respect to the remainder of the commentator's question, the Department considers Tdap to be a single dose vaccine. ACIP recommendation is for one dose of Tdap. A child who does not have a vaccine for which only a single dose is required may not be admitted to school. See § 23.85(e)(2). Tdap is the only vaccine in the list of required immunizations that is a single dose vaccine.

 Another commentator asked whether the statement that if a child is in 7th grade and has not had either Tdap or MCV immunizations, does not receive those immunizations throughout the 7th grade and enters the 8th grade still unvaccinated, the child is to be provisionally enrolled in the 8th grade.

 The commentator's statement is incorrect. The child should not be provisionally enrolled, the child should be excluded on the first day of school and remain excluded until the vaccinations are given. Section 23.83(c)(1)(iii), which the Department added in this final-form rulemaking to clarify this issue, states that if a child does not have an exemption as permitted by § 23.84 and does not receive the immunizations as required in subsection (c)(1)(i) and (ii) as required, the child may be excluded in that school year and each succeeding school year that the child fails to obtain the required immunization. Although MCV may be a multidose vaccine, the child should not have been provisionally admitted without a medical certificate setting out the time frame for obtaining the remaining required immunizations. If the child comes into the next school year and is out of compliance with that medical certificate, the child may be excluded without waiting for the 5-day provisional period to end. The Department notes that the same holds true for any other immunization in the regulations. The regulations require the immunizations in § 23.83(b) for continued attendance at school, not just for school entry.

 One commentator asked whether the 5-day provisional period applied to the single dose of MCV required in 7th grade, or whether a child that did not have the dose on the first day should be excluded.

 One commentator asked what the requirements would be for a child who had not been enrolled in a school in this Commonwealth for 7th grade and did not receive the first MCV shot.

 The Department clarified the regulation to respond to these questions. The Department added subsection (c)(1)(iii) to state that a child who does not have an exemption as permitted by § 23.84, and who does not receive the appropriate Tdap or MCV upon entry into 7th grade, may be excluded in that school year and each succeeding school year that the child fails to obtain the required immunization.

 Further, the MCV dose in 7th grade is the first of a multidose series. Therefore, because § 23.85(e)(1) states that ''if a child has not received all of the antigens for a multiple dose vaccine series. . .the school administrator or the school administrator's designee may not provisionally admit the child to school, unless the child has at least one dose'' and, in this case, the child has not received at least one dose, the child may not be admitted.

 The Department also added language to the MCV requirement for 12th grade to make it clear that a dose received after the child turns 16 years of age should be counted as the dose required for entry into 12th grade. See subsection (c)(2). This comports with the ACIP recommendations.

 With respect to the question regarding a child who is entering school in this Commonwealth without the required dose of MCV, the Department notes that the regulation allows a child moving or transferring into a school in this Commonwealth a 30-day period in which to provide immunization records to show proof of immunization, or to satisfy the requirements for and exemption under § 23.84. See § 23.85(g)(2). To clarify that the Department expects all immunization requirements to be met by the end of that 30-day period, the Department added language to § 23.85(g)(2) requiring the child to provide a medical certificate if the child cannot provide proof of immunization or an exemption under § 23.84. Therefore, a child without an MCV dose who cannot provide proof of immunization, a medical certificate or an exemption, or a combination of these records may be excluded at the end of the 30-day period until immunization requirements are met, and may also be excluded in each succeeding school year that they remain unmet.

§ 23.83(c)(2)—MCV required for entry into 12th grade

 The Department received many comments on the proposal to add a dose of MCV in the 12th grade. As stated, to clarify the requirements, the Department adds language in subsection (c)(2) to make it clear that a dose received after the child turns 16 years of age should be counted as the dose required for entry into 12th grade. This comports with the ACIP recommendations. The Department has not otherwise revised the regulation from the proposed rulemaking.

Comments in support of the 12th grade MCV requirement

 NMA, the March of Dimes, PAIC and PASA and one other commentator agreed with the Department's recommendation to add a dose of MCV for entry into the 12th grade. PASA stated that with nearly 70% of high school graduates planning to pursue postsecondary education opportunities, the additional immunization will ensure that students are protected from this potentially life-threatening disease.

 The President of NMA stated that it was an organization founded by families of children who were affected by meningococcal meningitis. She stated that she and three of the original five founders had lost children to the disease, and the other two founders had children who survived as quad amputees. She stated that they did not know that the disease was potentially vaccine preventable until it was too late. She stated that the only way to prevent the disease was through vaccination, and commended the Department's efforts to ensure that adolescents in this Commonwealth receive vaccines as recommended by ACIP.

 One commentator stated that she has already reviewed 1,100 9th to 12th grade immunization records in preparation for the addition of these requirements.

 The Department appreciates the support of these commentators.

 One commentator stated that she intended to send parents a letter with the proposed guidelines regarding the MCV requirement for 12th grade. The commentator requested a sample letter for parents, if one existed.

 The Department does not have a sample letter to parents. The Department cautions the commentator that until publication of this final-form rulemaking with an order making the regulations effective on a specific date, the requirements in the final-form rulemaking are not in place and no action should be taken.

Comments requesting addition of other meningitis vaccines

 One commentator recommended that the Department add all meningococcal vaccines receiving an A or B recommendation from ACIP, which would then allow the new meningitis B vaccines to be included in addition to MCV as a single dosage series. The commentator noted that there have been multiple outbreaks with meningitis B at college campuses within the last few years and ACIP now recommends meningitis B vaccine for children 16 to 23 years of age to provide short-term immunity against Neisseria Meningitidis serogroup B.

 The March of Dimes also pointed out that a vaccine exists for the remaining major circulating strain of the bacterial disease, meningitis B. The March of Dimes further commented that following outbreaks on college campuses, the FDA approved two vaccines for this strain. According to the March of Dimes, the CDC recommended permissive use of this vaccine in all children and young adults, 10 to 25 years of age, with the preferred age of administration at 16 to 18 years of age.

 PACIC noted that there are five different types of meningitis, however the CDC recommended vaccine only includes four strains of bacterial type A. PACIC noted that the vaccine does not contain strain B, which is the strain associated with more than 50% of meningococcal cases and deaths, particularly in children under 5 years of age.

 The Department acknowledges that the CDC has recommended permissive use of the meningitis B vaccination, however, it is not yet an ACIP recommendation. Until ACIP further reviews and recommends that vaccination, the Department will not add it to the recommended list.

Comments opposing the addition of an MCV requirement for cost and potential side effects

 Multiple commentators, including PACIC, disagreed with the Department's decision to require a dose of MCV prior to 12th grade. IRRC also noted that commentators state that this is unnecessary and significantly raises costs, and asked the Department to further explain the need for the additional dose and how the benefits outweigh the costs.

 Multiple commentators, including PACIC, cited the Department's Enterprise Data Dissemination Informatics Exchange database in 2014 as reporting only 16 new cases of meningitis. According to the other commentators, vaccinating the estimated 147,040 seniors in 2014 would have cost parents and taxpayers over $16 million. Another commentator stated that even if every 12th grader was vaccinated, and the vaccine prevented all cases of meningitis, this would cost citizens in this Commonwealth $1 million for each case of meningitis prevented. One commentator stated that the vaccine was very expensive. Several commentators stated that the CDC has recognized that the majority of the 320 million citizens in the United States will experience asymptomatic infection as children or young adults without complications and will develop antibodies against meningococcal disease that will protect them.

 One commentator cited the Pink Book as stating that 0.3% of those with serious adverse events will die. The commentator went on to say that using Colorado data, if 400,000 of Colorado's college students were inoculated with older vaccines, 4,000 adverse events can be expected, and 12 persons can be expected to die. The commentator states that the effects of widespread vaccination with the hastily-expedited B vaccine is not known, but according to the package inserts, 2% of students who receive the B vaccine will be sickened or hospitalized with a serious event. The commentator states that this could translate into an additional 8,000 sick students and 24 deaths, for a total of 12,000 sick and 36 dead in an attempt to prevent 3 meningitis cases. The commentator stated that before the Department could even recommend the meningitis vaccine, let alone mandate it, it must do a detailed analysis of the number of cases of B strain meningitis in this Commonwealth in 1 year and compare that number with the 0.3% of 12th graders who are likely to have serious adverse events. The commentator asked how many serious adverse events the Department considers as acceptable collateral damage, and why does the Department not think a parent has a say in whether or not their child risks that collateral damage.

 Several commentators raised issues regarding MCV's potential side effects. These commentators quoted the manufacturer's insert as predicting that 1% to 1.3% of inoculated children will suffer ''serious adverse effects.'' These commentators stated that, therefore, the risk of dying from the vaccine was greater than dying from the disease. These commentators also cited the Pink Book as forecasting that 0.3% of these will die from the vaccine. One of these commentators stated that since more people will die than will be helped by the vaccine, which costs $84 to $117 per shot, the vaccination is a financial windfall for the manufacturers at the expense of the public's health.

 Multiple commentators stated that the Pink Book states that 2% of the children to receive the vaccine suffer serious adverse events. The commentators stated that there have only been 390 cases of meningitis in the last year in the United States. The commentators stated that weighing the risks of serious adverse events having mandated meningitis vaccine and contracting the disease and having a serious reaction to receiving it shows that the vaccine is likely to cause more illness and death than it claims to stop.

 Several commentators, including PACIC, listed the side effects from the MCV vaccine manufacturer package insert, stating that post marketing surveillance for the meningitis vaccine has shown hypersensitivity reactions such as anaphylaxis/anaphylactic reaction, wheezing, difficulty breathing, upper airway swelling, urticaria, erythema, pruritus, hypotension, GBS, paresthesia, vaso- vagal syncope, dizziness, convulsion, facial palsy, acute disseminated encephalomyelitis, transverse myelitis and myalgia. One commentator stated that the most frequently reported adverse events were fever (16.8%), headache (16.0%), injection site erythema (14.6%) and dizziness (13.4%). The commentator stated that syncope was reported in 10% of reports and 6.6% were coded as serious (that is, resulted in death, life-threatening illness, hospitalization, prolongation of hospitalization or permanent disability). The commentator stated that serious events included headache, fever, vomiting and nausea. The commentator stated that the proposed rulemaking did not include costs of the serious side effects.

 PACIC stated that the clinical results of the brand name vaccine Menactra, a vaccine for meningitis, showed that 6.6% of events were coded to serious, that is, resulting in death, life-threatening illness, hospitalization, prolongation of hospitalization or permanent disability. Serious advents included headache, fever, vomiting and nausea, and a total of 24 deaths (0.3%) were reported. PACIC and another commentator asked if the 147,040 12th graders were given Menactra, the Commonwealth could expect 9,704 to have serious side effects and 29 to die. PACIC stated that this mandate would most benefit vaccine manufacturers who just happen to have offices in this Commonwealth. PACIC stated that the Department did not include costs of the serious side effects from the students who could suffer a reaction to the vaccine, and that this could clearly amount to millions more as many of the reactions will cause lifelong health problems.

 PACIC stated that the MCV vaccine had an inherent risk since it was an invasive medical procedure with documented side effects. PACIC commented that the vaccine only had an 80% to 85% efficacy rate, and that after 2 to 5 years, the vaccine has been found to be, at best, only 58% effective. PACIC stated that from 10% to 20% of the cases are fatal, with another 10% to 20% ending in brain damage or loss of limbs.

 Although the Department agrees that the case fatality rate from meningococcal disease is between 10% to 20%, and that very serious effects from the disease may occur, the Department disagrees with the commentators. The Department would not expect 29 of the children who receive the MCV vaccine for entry into 12th grade to die. MCV has been required for entry into the 7th grade since 2011, and the Department has not been made aware of this type of death rate among 7th grade children getting the vaccine. The Department also does not expect to get a financial windfall from the vaccine.

 The Department has not revised the regulation in response to these comments. Commentators postulated certain costs using the cost of the vaccine and the number of students who would be seniors in a particular year. Some commentators have taken the figures given by the Department in the RAF for the proposed rulemaking of approximately $16 million and have stated that for only 16 children who might get the disease, this cost is too great. This statement is misleading. The Department qualified this cost figure by stating on page 18 of the RAF for the proposed rulemaking that this would be the cost to the regulated community ''if every child were required to purchase the dose through private pay methods'' (emphasis added). In fact, parents and guardians will not be required to pay for the cost of the vaccine itself, although there may be a copay depending on the type of insurance the parent or guardian has. In the case of no insurance, the child's immunization will be paid for through the Federal VFC Program. The Department went on to say on page 18 of the RAF for the proposed rulemaking that:

Because, however, fully one-half of the population is be [sic] eligible for the Vaccines for Children Program, and would receive the vaccine either free of charge or for a vaccine administration fee, the cost. . .would be roughly $1,701,253. This is calculating the cost at the maximum regional charge in the Commonwealth, which is $23.14 per administration of the dose.

 Further, the MCV vaccine is covered by insurance under section 2713(a)(2) of the ACA so that parents or guardians who have insurance (and according to theInsurance Department, roughly 92% of residents of this Commonwealth are covered), should again only be paying a copay or administration fee. Section 2713(a)(2) of the ACA requires insurers to cover those vaccines that are recommended by ACIP, and MCV is recommended by ACIP. See generally ''Prevention and Control (2013).'' See also generally Bilukha, MD, PhD, O. O. and Rosenstein, MD, N (2005), ''Prevention and Control of Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP)'' (Prevention and Control (2005)), MMWR, 54(RR 7), 1—21, retrieved from http://www.cdc.gov/mmwr/pdf/rr/rr5407.pdf.

 Obviously, whether the parent or guardian purchases insurance or the child is covered by the VFC Program, there is cost to the parent or guardian for the premiums, on the one hand, and to the taxpayer, on the other, since Federal tax dollars support the VFC Program. The Department's addition of a second dose of MCV for students entering 12th grade should not impact either of these costs. Since ACIP includes MCV on its recommended list of immunizations, the cost of that immunization is already being calculated into the cost of insurance offered; the ACA requires MCV to be covered, regardless of whether it is on the Department's list. Further, even if the parent or guardian fails to obtain insurance, or the insurance does not cover the immunization, the Federal VFC Program provides vaccines to children who are uninsured or underinsured. Again, the VFC Program covers MCV independently of whether the Department adds it to the list of required immunizations for school.

 Further, the Department notes that as a part of ACIP's recommendation for administration of meningococcal vaccine, both in 2005 for the dose at 11 to 12 years of age, and again in 2013 with a second dose, a cost-effectiveness analysis was done. The latter study was done to determine the cost effectiveness of each of three strategies, a single dose at 11 years of age, a single dose at 15 years of age and a dose at 11 years of age with a booster dose at 16 years of age. According to the recommendation:

A multivariable analysis was performed with a Monte Carlo simulation in which multiple parameters were varied simultaneously over specified probability distributions. These parameters included disease incidence (46%—120% of the 10-year average), case-fatality ratio (34%—131% of the 10-year average), rates of long-term sequelae, acute meningococcal disease costs (i.e., inpatient care, parents' work loss, public health response, and premature mortality costs), lifetime direct and indirect costs of meningococcal disease sequelae (i.e., long-term special education and reduced productivity), and cost of vaccine and vaccine administration (range: $64—$114). Vaccination coverage (37%—90%) and initial vaccine efficacy (39%—99%) also were varied for evaluation purposes. The vaccine was assumed to be 93% effective in the first year, and then waning immunity was modeled as a linear decline over the next 9 years unless a booster dose was administered. The vaccine effectiveness of the second dose was assumed to be higher with a slower rate of waning immunity. The results of the cost-effectiveness analysis indicate that a 2-dose series at ages 11 years and 16 years has a similar cost-effectiveness compared with moving the single dose to age 15 years or maintaining the single dose at 11 years. However, the number of cases and deaths prevented is substantially higher with the 2-dose strategy (Table 5).

 ''Prevention and Control (2013),'' p. 13. According to ACIP, the two-dose strategy averted 184 cases (range 92—308), prevented 22 deaths (range 11—40) and saved 1,442 quality-adjusted life years (range 610—2,130) with a cost of $212,000 quality-adjusted life years saved (range 67,000—535,000). Based on this cost-effectiveness analysis, ACIP recommended the latter two-dose strategy.

 In 2005, when ACIP first considered the cost effectiveness of recommending a dose of MCV, it specifically addressed the cost of vaccine for college students. The analysis considered the economic costs and benefits of vaccinating a cohort of approximately 600,000 freshmen who lived in dormitories, and of all freshmen enrolled in United States' colleges, regardless of housing status. The analysis assumed that the vaccine benefit would last 4 years. ''Prevention and Control (2005).'' In the analysis, costs were varied: costs vaccine and administration (range $54—$88), costs per hospitalization ($10,924—$24,020), the value of premature death on the basis of lifetime productivity ($1.3 million—$4.8 million), the cost per case of vaccine side effects ($7,000—$24,540 per 1 million doses) and the average long-term costs of treating a case of sequelae of disease ($1,298—$14,000). The study also varied vaccine efficacy and coverage for evaluation purposes. According to ACIP's analysis, the vaccination of freshmen living in dormitories would result in the administration of approximately 345,950—591,590 doses of vaccine each year, preventing from 16 to 30 cases of meningococcal disease and 1 to 3 deaths each year. The analysis found that a cost of case prevented was an estimated $617,000 to $1.85 million, at a cost per death prevented of $6.8 to $20.4 million and a cost per life-year saved of $62,042 to $458,185. Given this data, ACIP recommended, in 2005, that there be routine vaccination of children 11 to 12 years of age. ACIP also recommended that routine vaccination for certain persons with a risk of meningococcal disease, including, college freshmen living in dormitories. ''Prevention and Control (2005).''

 At that time, the Department adopted ACIP's recommendation for children 11 to 12 years of age, but did not include a second dose. See 40 Pa.B. 2747. This cost analysis remains relevant, and the Department reconsidered its original decision, particularly given ACIP's 2015 recommendations and analyses regarding MCV.

 With respect to the statement that the cost of preventing only 16 children from getting meningococcal disease is too great for the community to bear, the Department again disagrees with the commentators and directs them to the comments of NMA.

 The Department acknowledges that there are risks to all vaccines. The only adverse events relevant to this final-form rulemaking are those in relation to MCV and to pertussis, which are the two vaccines added. The Department notes that in either case, a physician who has concerns about giving a child either vaccine may provide the child with a medical exemption. With respect to meningitis, the Department notes that the fatality rate is 10% to 15%, and 11% to 19% of survivors have long-term sequelae, including neurologic disabilities, limb or digit loss, and hearing loss. ''Prevention and Control (2013),'' p. 4; Control of Communicable Diseases Manual, p. 359. The fatality rate had been 50%, but antibiotics, intensive care units and improved supportive measures have decreased the fatality rate. Control of Communicable Diseases Manual, p. 359. MCV is transmitted from human to human through direct contact, including respiratory droplets. Control of Communicable Diseases Manual, p. 361. These are the same types of cost (that is, health care costs, potential deaths and loss of income for parents) to the Commonwealth and families that the commentators contend arise from the vaccine itself; however, the disease is preventable. All of these circumstances have costs to the Commonwealth, the parents of the affected child, the health system and the school system.

 The Department disagrees with the statement that meningitis vaccine potentially causes GBS. After reviewing safety studies, ACIP voted to remove the precaution for persons with a history of GBS because the benefits of meningococcal vaccination outweigh the risk for recurrent GBS in those persons. ''Prevention and Control (2013),'' p. 12. Since June 2010, no specific concerns have been raised about GBS in persons who have a history of that condition and who have been vaccinated with MCV. ''Prevention and Control (2013),'' p. 13.

 The Department considered the costs, including the possibility of side effects, and notes that ACIP's original analysis assigned a cost to possible adverse effects, and still recommended the vaccination. See ''Prevention and Control (2005),'' p. 12. In its most recent recommendation, ACIP has outlined the potential side effects as follows:

MenACWY-D

From licensure of MenACWY-D in January 14, 2005, through September 30, 2011, VAERS received 8,592 reports involving receipt of MenACWY-D in the United States; 89.0% reports involved persons aged 11 through 19 years. MenACWY-D was administered alone in 22.5% of case reports. The median time from vaccination to onset of an adverse event was 1 day. Males accounted for 40.6% of the reported events. The most frequently reported adverse events were fever 16.8%, headache 16.0%, injection site erythema 14.6%, and dizziness 13.4%. Syncope previously has been identified as an adverse event following any vaccination, with a higher proportion of syncope events reported to VAERS having occurred in adolescents compared with other age groups (89). Syncope was reported in 10.0% of reports involving MenACWY-D. Among all MenACWY-D reports, 563 (6.6%) were coded as serious (i.e., resulted in death, life-threatening illness, hospitalization, prolongation of hospitalization, or permanent disability).

Among those reports coded as serious, the most frequent adverse events reported included headache (37.5%), fever (32.5%), vomiting (23.6%), and nausea (22.2%). Cases of Guillain-Barré Syndrome (GBS) were recorded in 86 (15.3%) reports coded as serious, although the diagnosis has not been validated by medical records for all reports. A total of 24 (0.3%) deaths were reported, each of which was documented by autopsy report or other medical records and occurred in persons aged 10 through 23 years.

Among the 24 reports of death, 11 (45.8%) indicated that the cause of death was meningococcal infection (nine with a serogroup included in the vaccine and two with a nonvaccine serogroup). Among the other 13 (54.2%) reports of death, which occurred from the day of vaccination to 127 days following vaccination, stated causes of death were cardiac (five), neurologic (two), infectious (two), behavioral (i.e., suicide) (two), rheumatologic (one), and unexplained (one). There was no pattern among these reports. Except for the finding of GBS, which was further evaluated and is discussed below, no signals were identified in VAERS after MenACWY-D vaccination.

MenACWY-CRM

During February 19, 2010—September 30, 2011, VAERS received 284 reports of adverse events following receipt of MenACWY-CRM in the United States. Approximately three fourths (78.9%) of the reported events concerned persons aged 11 through 19 years. Males were the subject of 44.0% of reports; 45.4% of reports involved other vaccines administered at the same time, and 4.2% of reports were coded as serious. One death was reported, with the cause of death stated as unexplained. The median time from vaccination to adverse event onset was 0 days (the day of vaccination). The most common adverse event reported was injection-site erythema (19.7%) followed by injection-site swelling (13.7%). Syncope was reported in 8.8% of reports. No cases of GBS were reported. Administration errors (e.g., wrong diluent used or subcutaneous injection) without adverse events were described in 15.5% of reports involving MenACWY-CRM.

 ''Prevention and Control (2013),'' p. 12. Based on this data, and ACIP's recommendation, which included a cost-benefit analysis, and the FDA's licensure of the vaccine, which included a safety analysis, the Department chose to include a dose of MCV for entry into the 12th grade.

 The Department notes that there is a choice regarding costs, the choice of getting the vaccination and potentially having a side effect of the magnitude referenced by commentators, or potentially contracting the disease. The Department also has the authority to weigh the risks and benefits and choose to add a disease to the list, and has done so with meningitis. The Department takes the recommendations of ACIP and its own staff seriously, and believes the risks are greater than if the vaccine is not required.

 The Department notes that the General Assembly balanced that risk with regard to students living in high risk situations in college. The General Assembly considered the disease enough of a concern for college students, living in close proximity, and presumably sharing cups, toothbrushes and other items, to require that all institutions of higher education prohibit a student from residing in a dormitory or housing unit unless the student has been vaccinated against meningococcal disease. See the College and University Student Vaccination Act (35 P.S. §§ 633.1—633.3).¹⁰ The cost to obtaining the vaccine is covered, either by insurance or by the VFC Program, and is already factored into the costs of both. A parent may still take the position that the risk of the vaccine is too great for their child. In that case, the exemption process is still in place.

 PACIC and multiple commentators stated that the disease is very rare. Two commentators cited Robert F. Kennedy, Jr. as stating that meningitis was a rare disease that affected only 390 people Nationally last year. Another commentator stated that with only 30% of new cases being cause by the B strain, the conversation is about preventing only about 100 cases Nationwide each year. Another commentator cited Robert F. Kennedy, Jr. as stating that the package inserts of Menactra and Menveo¹¹ produce serious adverse events in 1% of recipients. Multiple commentators stated that the FDA and industry testing show that the vaccine is unusually low efficacy and high risk. Several commentators, including PACIC, stated that meningococcal bacteria become invasive only rarely, stating that ''[i]n a small proportion (less than 1%) of colonized persons, the organism penetrates the mucosal cells and enters the bloodstream.'' Multiple commentators, including PACIC, cited the CDC as giving the incidence rate as 0.3—0.5/100,000. Multiple commentators cited the Pink Book as saying that these bacteria become invasive only rarely. PACIC commented that it is difficult to develop the disease because an individual must be susceptible and have regular close personal contact, such as sharing a toothbrush or kissing a person who is colonizing meningococcal organisms.

 One commentator stated that the CDC's web site says that the disease is extremely rare and that death happens to an even smaller percentage of persons than are colonized with the bacteria. The commentator stated that all vaccines come with risk, and the risk of injecting all teenagers with yet another vaccine with a lot of risk for a disease they will not get is unfair.

 One commentator stated that the vaccine is superfluous and that communicability is rare and that there are about 3,000 cases in the United States annually. The commentator stated that this would be costly for 12th graders, and cost money through additional staff hours for paperwork and follow-ups.

 Several commentators cited the CDC as stating that all serogroups of this disease are on the decline. Several commentators noted that Serogroup B, not included in the vaccine, declined along with the serogroups included in the vaccine for unknown reasons. These commentators cited the CDC as saying that the communicability of Neisseria meningitidis is generally limited. ''In studies of households in which a case of meningococcal disease has occurred, only 3%-4% of households had secondary cases.'' Furthermore, ''in the United States, meningococcal outbreaks account for less than 2% of reported cases (98% of cases are sporadic).'' Therefore, according to these commentators, transmission in the school setting is very unlikely. One commentator opposed any amendment to the immunization regulations, but particularly an additional dose of MCV in the 12th grade.

 The Department disagrees with the commentators and has not revised the regulation in response to the comments. Although a case of meningitis is rare, a single case of meningitis has a 10% risk of death and a high risk of long-term disability (deafness, limb loss or intellectual impairment). The disease is misleading and may at first appear to be something less serious. The initial symptoms are similar to those caused by influenza (fever, intense headache, nausea, vomiting, stiff neck and sensitivity to light). The onset is very fast, and serious symptoms develop quickly. The most severe form of infection includes petechial rash (caused by subcutaneous hemorrhage), hypotension, disseminated intravascular coagulation and multiple organ failure. Control of Communicable Disease Manual, p. 359. The case fatality rate had exceeded 50%. However, antibiotics, intensive care units and improved supportive measures have allowed more people to survive. Control of Communicable Disease Manual, p. 359.

 Further, for each case, all close contacts require antibiotic prophylaxis, which creates a substantial effort and cost for the public health community. Four cases have been seen at Pennsylvania State University since 2008. In one case, no additional public health intervention was required. In a case in 2009, the student was hospitalized in serious condition, and all fraternity members of the fraternity where he lived were advised to seek treatment and 40 did so. See http://news.psu.edu/tag/meningitis.

 The Department recognizes that the MCV vaccine does have side effects, and that no vaccine is 100% safe. In making the decision to license a vaccine, the FDA takes into consideration and weighs potential side effects and deaths in determining whether the vaccine is in fact safe for use. The FDA licensed MCV because it determined that the risks to contracting meningitis far outweigh the risks from the vaccine. ACIP recommended it for that reason. Further, during 2009-2010, when routine vaccine use was recommended and supply of the vaccine sufficient, the CDC suggests that the decline seen in two serogroups, C and Y among adolescents 11 to 18 years of age, suggested an impact of vaccination on adolescent disease. ''Prevention and Control (2013),'' p. 5.

 Further, studies of cost-effectiveness of the first dose of MCV, performed by groups other than ACIP, determined that routine vaccination of United States adolescents would prevent 270 meningococcal cases and 36 deaths in the vaccinated cohort over 22 years, which is a decrease of 46% in the expected burden of disease. Shephard, C. W., Ortega-Sanchez, I. R., Scott, II, R.D. and Rosenstein, N. E. (2005), ''Cost-Effectiveness of Conjugate Meningo- coccal Vaccination Strategies in the United States,'' Pediatrics, 115(5), 1220—1232.

 Again, those parents who have lost children to meningitis, or have had their children severely disabled because the vaccine was not available or they were not aware of the vaccine, feel as strongly that the vaccine should be required.

 The Department, reviewing ACIP recommendations and relying upon the cost-benefit analysis done over both doses of the vaccine, determined that the risks outweigh the benefits, and that for a child to die from a preventable illness is unconscionable.

 PACIC and another commentator stated that the meningitis vaccines contain neurotoxins such as formaldehyde, aluminum hydroxide, polysorbate 80 and thimerosal in multidose vials, among others.

 The Department addressed comments regarding vaccine additives previously in this preamble.

 PACIC stated that VAERS, which includes only a small fraction of the health problems that occur after vaccination in the United States, reports 1,799 severe adverse effects resulting from meningococcal vaccine, which only began to be used in 2005. PACIC stated that when Haemophilus influenzae type b (Hib) vaccine is included, the number jumps to 62,676. PACIC stated that there are more than 2,000 serious health problems, hospitalizations and injuries reported following meningococcal shots, including 33 deaths, with half the deaths occurring in children under 6 years of age.

 The Department disagrees with the commentator. These numbers are not accurate for the vaccine that the Department is requiring. The Department is not requiring the Hib vaccine. The Department is requiring MCV for children in the 12th grade. Children under 6 years of age do not receive the same meningococcal vaccine as children entering 12th grade. The Department is not requiring meningococcal vaccine for school entry.

 One commentator provided several studies on efficacy, adverse events and conflicts of interest, pointing out that vaccine companies provided financial support and employment to some of the researchers, there were adverse effects noted in the studies that caused some participants to drop out, there was evidence that immunity waned after 5 years, cost effectiveness in a vaccine used for meningitis B was not as impressive as it had appeared pre-licensure, the MMR vaccine caused measles inclusion body encephalitis and six other vaccines, including one for meningitis caused syncope (fainting) and frozen shoulder, and there was a possibility of Henoch-Schonlein purpura.

 The Department disagrees with the commentators and has not revised the regulation. The Department relied upon the opinion of ACIP, which is made up of experts in the fields of immunization practices and public health, use of vaccines and other immunobiologic agents in clinical practice or preventive medicine, clinical or laboratory vaccine research, assessment of vaccine efficacy and safety, consumer perspectives and/or social and community aspects of immunization programs.

 The Department, with the approval of the Board, following ACIP recommendations, is of the opinion that the vaccine will save the lives of children, and that the cost effectiveness of the vaccine has been reviewed and the vaccine is determined to be cost effective. In any case, raising the cost of the vaccine is misleading. The Department has discussed this more fully previously in this preamble.

Comments regarding vaccine ''kick-backs''

 Several commentators stated that this sounded like an income driven mandate and that someone would make a lot of money with this single vaccine in this Commonwealth. One commentator stated that this was a game of profit for vaccine manufacturers and those who accept their money in government and health departments.

 The Department will not receive money from the addition of this requirement.

Comments regarding reporting and paperwork requirements

 Several commentators stated that adding MCV in the 12th grade will add a third reporting requirement, placing a burden on schools, adding more staff hours, paperwork regarding provisional timelines, filing of waivers and individual follow ups.

 The Department disagrees with the commentators. The addition of MCV into the 12th grade does not add additional reporting requirements for schools. Schools are required to report on children in kindergarten and in the 7th grade because those are the requirements on the Department's reporting form. See § 23.86(f)(2)—(7). There will be no additional reporting requirements for the 12th grade dose of MCV.

 The additional 12th grade vaccine dose will require schools to conduct the same type of review prior to the start of school for compliance, and the same type of follow-up after the 5-day provisional period as is required for any child who fails to obtain any required vaccination under this final-form rulemaking. The Department extended the time period for implementation of this final-form rulemaking so that schools, school nurses, parents and guardians will have nearly 6 months to obtain this required immunization for children entering 12th grade in fall 2017. This vaccine is not required for the entire student population, but only for those students entering 12th grade in fall 2017. The number of students in 12th grade in the 2015-2016 school year was 146,320. The Department is hopeful that the 5-month to 6-month period prior to the implementation of this requirement, and the outreach the Department intends to do, will significantly reduce the numbers of students who will need to obtain a second dose of MCV at the beginning of the 2017-2018 school year.

Comments regarding college attendance

 One commentator stated that MCV is already required by many colleges, and students would be receiving the vaccine in a year or so already without adding a requirement to the public school schedule. The commentator stated that most cases of meningitis are sporadic and do not cause outbreaks.

 One commentator stated that she disagreed strongly with this requirement because students who choose to go to college are not required to get a meningitis vaccine or can file for an exception. One commentator stated that the MCV regulation was not required until a child went to college. One commentator stated that it was ludicrous to add a vaccination for every high school student with a reasoning that it is good for them for entering college, which they are not doing yet. The commentator stated that it should be a college requirement.

 The Department has not revised the regulation to eliminate the requirement. The Department did not add the requirement to the regulation to ensure a child's admittance to college, but to protect that child and other children to the greatest extent possible from a very serious illness that can result in death. In adding the requirement, the Department is following ACIP's recommendation, adopted by both AAP and AAFP, to ensure that the child receives the vaccination at the appropriate time to boost the child's immune system, and provide immunity if the child does enter college at a later date.

 In fact, by law, children are required to have MCV vaccination before they may live in a college dormitory under the College and University Student Vaccination Act. It is partly in preparation of this requirement that the Department added the 12th grade requirement in these regulations. The Department added one dose of MCV for entry into the 7th grade in 2011. ACIP now recommends an additional dose to ensure immunity. ''Prevention and Control (2013),'' p. 12. Failure to receive this dose in a timely manner could result in a student being excluded from dormitories, and could thus result in additional cost to parents and students attending college.

 With respect to the comment regarding the sporadic nature of the disease, while that is true, as the Department has stated, a single case of meningitis has a 10% risk of death and a high risk of long-term disability (deafness, limb loss or intellectual impairment). The Department previously discussed this. Further, for each case of meningitis, the public health response is intensive and expensive. Health departments shall locate all close contacts, by contact tracing methods, and then all close contacts require antibiotic prophylaxis, which is a substantial public health effort.

Legislative action to require 12th grade dose

 Multiple commentators, including PACIC, noted that the General Assembly was considering a bill to require MCV for children entering 12th grade, but the bill did not pass. Therefore, according to PACIC and these commentators, the Department is seeking to circumvent the legislative process.

 One commentator said the Department's continuing in this regard after the General Assembly refused to entertain the bill seems both unethical at best and at worst motivated by something other than care for these precious young people on the brink of their adult future, and begged the Department to reject the pressure from vaccine manufacturers with billions of dollars at stake.

 The Department disagrees with the commentators' statement that it is circumventing the legislative process by adding MCV to the list of required immunizations through regulation. The Department also disagrees that it is acting unethically or is motivated by money promised by vaccine manufacturers. The commentators should note that, as part of the regulatory process, the Department is required to serve its regulations on the standing committees of the House of Representatives and the Senate of Pennsylvania, and the standing committees have the ability to review and approve or disapprove the regulations.

 In addition, the General Assembly gave to the Department the authority to determine against which diseases, infections and conditions a child shall be immunized before entering or attending school. Section 16(a) of the Disease Prevention and Control Law of 1955 provides the Board with the authority to issue rules and regulations on a variety of matters regarding communicable and noncommunicable diseases, including what control measures are to be taken with respect to which diseases, provisions for the enforcement of control measures, requirements concerning immunization and vaccination of persons and animals, and requirements for the prevention and control of disease in public and private schools. Section 16(b) of the Disease Prevention and Control Law of 1955 gives the Secretary of Health (Secretary) the authority to review existing regulations and make recommendations to the Board for changes the Secretary considers to be desirable.

 The Department also finds general authority for the promulgation of its regulations in The Administrative Code of 1929. Section 2102(g) of The Administrative Code of 1929 gives the Department this general authority. Section 2111(b) of The Administrative Code of 1929 provides the Board with additional authority to promulgate regulations deemed by the Board to be necessary for the prevention of disease, and for the protection of the lives and the health of the people of this Commonwealth. That section further provides that the regulations of the Board shall become the regulations of the Department.

 The Department's specific authority for promulgating regulations regarding school immunizations is found in The Administrative Code of 1929 and in the Public School Code of 1949. Section 2111(c.1) of The Administrative Code of 1929 provides the Board with the authority to make and revise a list of communicable diseases against which children are required to be immunized as a condition of attendance at any public, private or parochial school, including kindergarten. Section 2111(c.1) of The Administrative Code of 1929 requires the Secretary to promulgate the list, along with any rules and regulations necessary to insure the immunizations are timely, effective and properly verified.

 Section 1303 of the Public School Code of 1949 provides that the Board will make and review a list of diseases against which children shall be immunized, as the Secretary may direct, before being admitted to school for the first time. That section provides that the school directors, superintendents, principals or other persons in charge of any public, private, parochial or other school, including kindergarten, shall ascertain whether the immunization has occurred, and certificates of immunization will be issued in accordance with rules and regulations promulgated by the Secretary with the sanction and advice of the Board. Merely because the General Assembly may itself, from time to time, attempt to legislate in the area of public health does not mean it in any way has diminished the Department's authority to promulgate regulations under legitimately delegated authority.

Comments regarding the National Childhood Vaccine Injury Act of 1986 and program

 Multiple commentators stated that persons injured because of vaccines will not be able to sue the manufacturer for damages because the manufacturer is protected by the National Childhood Vaccine Injury Act of 1986, which grants liability protection to manufacturers. These commentators stated that the National Childhood Vaccine Injury Act of 1986 partially shields companies selling vaccines in the United States from civil liability, and in 2011 the United States Supreme Court completely shielded vaccine manufacturers from liability for FDA-licensed and CDC-recommended vaccines. According to the commentators, there is no product liability or accountability for pharmaceutical companies marketing Federally-recommended and State-mandated vaccines that injure Americans or cause their death, which makes flexible medical and nonmedical vaccine exemptions in vaccine policies and laws the only way Americans can protect themselves and their children from vaccine risks and failures. One commentator stated that in this program records are sealed and there is no discovery so that the true extent of acknowledged vaccine injuries is hidden from the public.

 One commentator stated that until vaccine manufacturers are held accountable for the vaccines they produce, just like the drugs they produce, vaccines should not be added to the schedule. The commentator stated that there are over 300 vaccines in the works right now, and children already receive 30 vaccines by the time they are 6 years of age.

 Several commentators stated that both MCV and Tdap carry risks of injury or death. The commentators stated that Congress passed the National Childhood Vaccine Injury Act of 1986 in recognition of this fact. The commentators stated that the National Vaccine Injury Compensation Program has awarded more than $3.2 billion to children, adults and families injured by vaccines. One commentator states that it is $3.3 billion, and this with the majority of claims being denied in the closed government run process. According to the commentators, two out of three persons are denied compensation.

 One commentator took issue with the Department's failure to reference the National Childhood Vaccine Injury Act of 1986 in section 9 of the RAF for the proposed rulemaking, which asks for any relevant Federal or State court decisions that impact upon the proposed rulemaking. The commentator is of the opinion that the National Childhood Vaccine Injury Act of 1986, which created the Vaccine Court, is of great relevance, since it prevents families in this Commonwealth from suing vaccine manufacturers if they are injured by a vaccine. The commentator stated that all decisions by the Vaccine Court are relevant to the regulations.

 The Department disagrees with the commentators. Section 9 of the RAF asks ''Is the regulation mandated by any federal or state law or court order, or federal regulation? Are there any relevant state or federal court decisions? If yes, cite the specific law, case or regulation as well as, any deadlines for action.'' In fact, there is no State or Federal law, regulation or court order that has an impact on these regulations. The Department does not believe the decisions made by the Vaccine Court impact these regulations, as they involve individual petitioners bringing cases with circumstances unique to them. Nothing in those cases requires the Department to, or prohibits the Department from, amending its regulations.

 The Department is aware of the Vaccine Court and the National Childhood Vaccine Injury Program, created by the National Childhood Vaccine Injury Act of 1986. The purpose of the National Childhood Vaccine Injury Act of 1986 was both to set up a route to compensation for persons injured by vaccines that would be less costly and difficult than typical tort litigation and to encourage vaccine manufacturers to continue production and development of new vaccines. Bruesewitz, p. 226 and 227. Awards are paid out of a fund created by an excise tax on each vaccine dose. Bruesewitz, p. 226 and 227.

 The program allows children who are harmed by vaccines to obtain compensation for injuries suffered after receiving immunizations. To receive an award, a petitioner must make a number of factual demonstrations, including that the child received a vaccination covered by the National Childhood Vaccine Injury Act of 1986, received it in the United States, suffered a serious long lasting injury and received no previous award or settlement on account of the injury. Cedillo v. Secretary of Health and Human Services (Cedillo) (2009 WL 331968), slip op. at 2, affirmed, Cedillo v. Secretary of Health and Human Services, 617 F.3d 1328 (Fed. Cir. 2010). The petitioner shall also establish a causal link between the vaccine and the injury. Cedillo, slip op. at 2. If the petitioner is able to show that the vaccine recipient suffered an injury listed on the Vaccine Injury Table created through the National Childhood Vaccine Injury Act of 1986, and corresponding to the vaccine in question, within an applicable time frame, then there is a presumption that the vaccine caused the injury, and the child is automatically entitled to compensation, unless it is affirmatively shown that the injury was caused by some other factor. Cedillo, slip op. at 2.

 If the injury is not included in the table, the petitioner may still receive compensation if the petitioner is able to show causation in fact, and the petitioner must show by a preponderance of the evidence that the vaccine actually caused the injury in question. Cedillo, slip op. at 3. The petitioner must show that the vaccination was at least a substantial factor in causing the condition, and must show proof of a logical sequence of cause and effect that the vaccine was the reason for the injury. The logical sequence must be supported by reputable medical or scientific explanation. Cedillo, slip op at p. 3. The United States Supreme Court characterized the National Vaccine Injury Compensation Program as ''a no-fault compensation program.'' Bruesewitz, p. 223.

 The existence of the National Vaccine Injury Compensation Program does not completely shield a vaccine manufacturer from liability as alleged by commentators. The commentators make this claim because in Bruesewitz the United States Supreme Court stated that a vaccine manufacturer could not be held liable for a design-defect, and that the act expressly eliminated liability for a vaccine's unavoidable, adverse side effects. Bruesewitz, p. 230. Commentators would like to prohibit all vaccines that are not 100% safe and effective. The United States Supreme Court, like the CDC, AAP, AAFP, the Department and the Board, recognized the importance of childhood vaccines, Bruesewitz, p. 226, and the need for their use and development despite the fact that they cannot be made 100% safe. This does not mean that manufacturers are shielded from all liability. A petitioner under the National Childhood Vaccine Injury Act of 1986 who is not satisfied with his award may reject it and seek tort relief from the vaccine manufacturer. Bruesewitz, p. 228. Further, a vaccine manufacturer who fails to comply with regulatory requirements (which include certain warning requirements to physicians or the petitioner), who commit fraud, who intentionally or wrongfully withhold information, or who engage in other criminal or illegal activity are not shielded from liability. Bruesewitz, p. 229.

 With respect to the comment that 300 vaccines are currently ''in the works right now,'' and children already receive 30 vaccines by the time they are 6 years of age, the Department has no way of knowing how many vaccinations are in research and development. The Department previously addressed the fact that although ACIP may recommend many vaccinations, the Department and the Board do not adopt all vaccinations for school entry and attendance.

 The Department previously discussed safety of the MCV, DTaP, combination vaccines, multiple doses of vaccines, the number of vaccines and the issues of the credibility of the CDC and the Federal government elsewhere in this preamble.

 PACIC and another commentator stated that at any given time between 20% and 40% of the population are asymptomatically colonizing meningococcal organisms in nasal passages and throats, which boosts innate immunity to invasive bacterial infection. PACIC and the commentator stated that by the time American children enter adolescence, the vast majority have asymptomatically developed immunity to meningitis.

 The Department disagrees with the commentators. While somewhere around 10% of the population carries Neisseria meningitidis in their nasopharyngeal tract at any given time, carriage is transient and does not result long-term immunity. In addition, there are multiple serogroups of the organism, with little cross-immunity. The strains that cause colonization may not be the same as those that cause invasive disease. See Control of Communicable Diseases Manual, p. 361.

 PACIC stated that the Department already mandates 25 doses of 12 vaccines. PACIC stated that the meningococcal vaccine is available for those who would like to use it.

 The Department requires ten vaccinations for school entry. If a child has a medical or religious exemption, he may attend school without those requirements. The Department agrees that the MCV vaccine is available for those who choose to use it, but after reviewing recommendations by ACIP, and noting that AAP and AAFP have adopted ACIP's recommendations, the Department, with the approval of the Board, is requiring this immunization for entry into 12th grade.

Application of 12th grade MCV requirements

 Several commentators questioned how the requirements for the 12th grade MCV would apply. One commentator asked the Department to revise the language regarding the meningitis vaccine to make the requirements more clear. IRRC also asked that the Department clarify whether the requirements apply only to those students entering kindergarten, 7th and 12th grades, whether they apply retroactively to all current students and how they apply to students moving into new school districts. IRRC also asked that the Department clarify whether a third dose would be required for students who get MCV after 7th grade but before the child's 16th birthday.

 Two commentators asked if a student going into the 12th grade would be required to have a second dose of MCV unless the student had received a dose of MCV on or after the student's 16th birthday. The commentators asked how this would affect a child in the 8th through 11th grades who does not have proof of even one MCV vaccine. The commentators asked whether the child would be required upon entry into any of those grades to get the first dose of MCV, and should they be excluded.

 One commentator stated that school nurses had been asking for MCV to be required not just for entry into 7th grade, but for students in 7th grade and in every grade thereafter until graduation. Therefore, to have a second dose before 12th grade is really requiring two doses before entry into 12th grade.

 Two commentators recommended that the Department revise the regulation to require all children from 7th through 12th grades to receive the Tdap vaccine. One commentator recommended that this include both students transferring from outside this Commonwealth as well as homeschooled students.

 One commentator asked if a child had a MCV shot for entry into the 7th grade and one at 16 years of age, whether an additional shot would be required upon entry into 12th grade.

 The Department revised the regulation to add language clarifying its intent. The language provides that if a child does not have MCV or Tdap upon entry into the 7th grade, a child may be excluded in the 7th grade and in each succeeding school year that the child fails to obtain the required immunization. See § 23.83(c)(1)(iii). The Department previously discussed the requirements regarding Tdap and MCV in 7th grade. With respect to MCV, because ACIP recommends a single dose for a child who has not received a previous dose on or after the 16th birthday, as commentators noted, the Department added language to § 23.83(c)(2) to make it clear that a dose of MCV received at 16 years of age or older is to be counted as the 12th grade dose. There is no ACIP recommendation for a third MCV dose and the regulations do not contemplate a third dose.

 IRRC asked how the final-form rulemaking would apply to children entering kindergarten and whether they apply retroactively. The regulations apply to all students throughout their school careers, although the Department would not use the term ''retroactively.'' The regulations do not state that specific vaccines are required only upon entry to kindergarten, and that the immunizations required are ''once and done.'' The regulations require that certain immunizations be obtained for school attendance, not simply for school entry. See § 23.83(a). The Department made this change to the regulations several years ago to take into account and to emphasize the fact that immunizations were not just required when the child enters school for the first time, but throughout the child's attendance at school. If a child reaches the 6th grade, for example, without being excluded for not having the required polio immunizations, the child may still be excluded at any time during the 6th grade, since the immunization is required for attendance. Thus, a child may be excluded during any school year in which the child lacks the required immunizations and neither fits within a waiver nor has an exemption.

 Further, the Department added language to § 23.83(c) to clarify that a child who does not have an exemption as permitted by § 23.84 and who does not receive the immunizations as required under § 23.83(c)(1)(i) and (ii) may be excluded in that school year and each succeeding school year that the child fails to obtain the required immunization. See § 23.83(c)(1)(iii).

 One commentator asked whether a child who had not previously received a dose of MCV before the child turned 16 years of age would fall within the exclusionary period regarding single dose vaccines. She stated that if that was the case, many seniors would be one-dose candidates, which could lead to exclusion on day one of school. She stated that school nurses and schools would need adequate preparation.

 The Department does consider the meningitis conjugate vaccine to be a multiple dose series. The Department agrees that adequate time for preparation and informing students and parents is necessary to avoid unnecessary exclusions, particularly in the senior year. To provide sufficient time for adequate preparation by parents, guardians, health care practitioners, schools and school nurses, the Department revised the time frame for implementation of this final-form rulemaking to the 2017-2018 school year. This will provide schools and school staff adequate time to provide information to parents and guardians and their children. The change in the time frame will also allow the Department adequate time to provide guidance to schools, school nurses and health care practitioners regarding these requirements.

 Two commentators asked why the Department did not require MCV in the 11th grade, at which time a child is required to have a physical, rather than on entry into the 12th grade. One of these commentators stated that this would be more cost effective to the parents because this would require only one trip to the doctor.

 The Department has not revised the final-form rulemaking. The Department is requiring that the child have the vaccine upon entry into the 12th grade. See § 23.83(c)(2). If the child gets the vaccine at the 11th grade physical and the child is 16 years of age or older, the immunization would be considered valid for the requirement that the child have the immunization upon entry into the 12th grade. See subsection (c)(2) (''[a] dose of MCV received at 16 years of age or older shall count as the 12th grade dose.'').

 One commentator asked when it would be required that 12th grade students have the second dose of MCV, and whether it would be required for all students at that age level.

 The requirement for MCV is for all students at entry into 12th grade, or in an ungraded class, for students in the school year that the student is 18 years of age. See § 23.83(c)(2). This is the case unless the child has a medical or religious/philosophical exemption, or if some other waiver is in place as contemplated by the regulations. See § 23.85(g). This requirement will be effective August 1, 2017, allowing for 5 to 6 months' notice to parents, guardians and schools.

 IRRC asked that the Department clarify what would happen if a child came from out-of-State without the first dose of MCV. One commentator asked the Department to clarify what would happen if a child moved from another state into Commonwealth schools in 9th to 11th grades without a meningitis vaccination. The commentator asked whether the child would be excluded until one meningitis vaccination was obtained. Another commentator asked if a child was not in this Commonwealth for 7th grade and missed the first dose, would the vaccine now be considered to be a two series vaccine.

 The Department revised the regulation to clarify this issue. The Department considers the MCV vaccine to be a two-dose series, now that a second dose will be required for entry into the 12th grade. See § 23.83(c)(2). The fact that a child is not in this Commonwealth for the first dose does not have a bearing on the question of whether or not the vaccination is a one-dose or two-dose vaccination. There are other provisions that cover what action to take regarding a child who comes into this Commonwealth without a 7th grade dose of MCV and what would happen in succeeding years if child continued to remain unvaccinated. This final-form rulemaking provides that a child who moves into this Commonwealth has a 30-day period to obtain records of immunizations. See § 23.85(g)(2). If the child moves into this Commonwealth after 7th grade with no record of a Tdap or an MCV dose, or without records of a required immunization, the child may be excluded at the end of that 30-day period until the requirements of Chapter 23, Subchapter B (relating to school nurse services) are met. This exclusion may continue into subsequent school years. The Department added language to § 23.85(g)(2) to clarify that fact. These regulations apply to children transferring into a school from outside this Commonwealth unless one of the provisions of § 23.85(g) applies. As a point of clarification, this final-form rulemaking does apply to children being homeschooled, and has done so prior to this final-form rulemaking, as the definition of ''school'' has not been amended and includes home education programs. See § 23.83(a).

 As the Department has noted, MCV is a two-dose series. A third dose is not recommended by ACIP, or required by the Department.

§ 23.85. Responsibilities of schools and school administrators

§ 23.85(e)(1)—Multiple dose vaccine series—provisional period

 The Department received many comments on the proposed amendment to change the 8-month provisional period to a requirement that a child have all single dose vaccines on the first day of the school year and the most up-to-date dose of a multiple dose vaccination series within 5 days of the start of school, along with a signed medical certificate providing dates for the remaining required doses. Many of the comments received were from school nurses. Some commentators spoke up in support of the proposed amendment, some disagreed with the proposed amendment and recommended other time frames, and some disagreed with the 5-day time frame but did not offer recommendations. Some commentators expressed concern with the time frame for implementation expected by the Department, which was for the proposed rulemaking to be effective for the 2016-2017 school year.

 IRRC noted that commentators generally supported the proposed amendment, but that those commentators felt that the length of time was not feasible for school nurses or parents, and that it might put a child who needed multiple vaccines at risk. IRRC asked the Department to explain the reasonableness of the time frame and how it adequately protects the public's health.

 In the following paragraphs, the Department will explain its rationale for the 5-day provisional period within which children are expected to become vaccinated to enter and attend school. The Department will then detail the specific comments received, as well as the different time frames proposed by commentators but without reiterating its rationale each time a comment relates to the 5-day period.

 The Department reviewed data regarding disruption and cost of outbreaks of vaccine-preventable diseases in schools and other settings, some of which is within its own experience, some of which is the experience of other states. All of this experience is relevant, since disease surveillance and control methodologies may differ from disease to disease, but not from state to state. In the Department's view, and as the agency charged with protecting the health and safety of the citizens of this Commonwealth, and with choosing the most efficient and effective way of doing so, see section 2102(a) of The Administrative Code of 1929, the Department decided to adopt the 5-day period for a number of reasons.

 A key reason for the 5-day period is to achieve herd or community immunity as quickly as possible. The Department discussed the concept of herd or community immunity at length in the ''comments regarding 'herd' or community immunity, vaccine effectiveness and natural immunity'' section of this preamble and will not repeat it here.

 The Department notes that this final-form rulemaking will be effective August 1, 2017. The Department acknowledges the need for education and outreach on these regulations, particularly the 5-day requirement, and intends to do both with health care practitioners, schools and parents.

 In addition, as a number of commentators pointed out, too lengthy a provisional period requires school nurses to send multiple written notices and make multiple phone calls to parents to attempt to gather all necessary immunization information.

 Finally regarding the 5-day period, and contrary to some commentators' assumptions, neither the Department nor the regulation requires a child to obtain all immunizations at the same time on the same date or within the 5-day period. The Department's intention is not to require a child to obtain all required immunizations at the same time on the same date. Presumably the number of children lacking all vaccines at school entry are minimal, and those children may have some type of medical or philosophical/moral exemption. To the extent there are no grounds for either a medical or religious/philosophical exemption, the Department presumes that parents and guardians are acting responsibly, on the medical advice of their primary care practitioners, and are giving their children vaccinations on schedule. This final-form rulemaking requires a child to have any single dose vaccine upon school entry, or risk exclusion. In the case of a multidose vaccine, this final-form rulemaking requires that the child have at least one dose of the vaccine upon entry into that school year, and then, if additional doses are required and are medically appropriate within the first 5 days of school, the child must have either the final dose during that 5-day period or have the next scheduled dose and also provide a medical certificate setting out the schedule for the remaining doses. If the child has at least one dose, but needs additional doses, and those doses are not medically appropriate during the first 5 days of school, the child may provide a medical certificate on or before the 5th school day scheduling those doses. The medical certificate shall be signed by a physician, CRNP or PA. If the child receives the immunizations from the Department or a public health department, a public health official may sign the medical certificate. A child who fails to meet these requirements risks exclusion.

 If it takes longer than 5 days to obtain the number of immunizations required, the child may still continue to attend school so long as the child continues to receive immunizations according to the schedule in the medical certificate. This should allow for the child to receive vaccinations in a safe and medically appropriate way according to the child's health care practitioner.

 Regarding commentators' concerns that multiple vaccines put children at risk, the Department disagrees. The Department has addressed those comments throughout this preamble when raised in connection with other parts of this final-form rulemaking. A number of studies have been conducted to examine the effects of giving various combinations of vaccines simultaneously. In fact, neither ACIP nor AAP would recommend the simultaneous administration of any vaccines until these studies showed the combinations to be both safe and effective. These studies have shown that the recommended vaccines are as effective in combination as they are individually, and that these combinations carry no greater risk for adverse side effects. Consequently, ACIP and AAP recommend simultaneous administration of all routine childhood vaccines when appropriate.

 The Department discussed combination vaccines in more detail previously in this preamble.

 One commentator was not in favor of the 8-month provisional period. The commentator stated that this would extend noncompliance from one school year to another. The commentator recommended that the Department implement a mass immunization model similar to ones carried out in the 1950s and 1960s. The commentator recommended utilizing school nurses to provide in-school team health screenings, and get the nursing staff more intimately involved with the student population, including discussions of subjects like hand hygiene to decrease the spread of disease. The commentator suggested that the mass immunization administration program could be designated as a revenue enhancement through allocated funding to the schools in support of improved health outcomes as demonstrated by decreased school absenteeism, and possibly improved academic scores.

 The Department agrees that the 8-month provisional period is too long, and potentially harmful to students and the public. This concern is what led to the Department's determination to reduce that 8-month period to 5 days for multidose vaccines along with a medical certificate for remaining doses, and to immediate possibility of exclusion for single dose vaccines. While the Department appreciates the recommendations regarding mass immunization clinics and increased school nurse involvement in the student population, unlike the 1950s and 1960s, vaccines received by the Department through its Federal immunization grant are reserved by the terms of that grant for a limited area of the population. Schools are able to utilize this vaccine in catch up programs for that population, but it is not available to the general public as it once was. Recommendations regarding the best use of school nurses and school health programs are beyond the scope of this particular regulation.

 One commentator stated that the time period difference in the provisional period between single dose and multiple dose immunizations was a great idea.

 The Department appreciates the commentator's support.

 Several commentators recommended that all students beginning school in this Commonwealth have their immunizations before school starts. One of these commentators said that the process is extremely long, and involves many telephone calls and letters to get immunizations updated. The commentator complained that many times addresses and telephone numbers are incorrect, or messages cannot be left because of phone issues. The commentator said that it was very hard to get people to understand the process, even using the language line, because every school does immunizations differently.

 The Department appreciates that school nurses work very hard to ensure that the children under their care have the appropriate immunizations. The Department acknowledges the difficulties a language barrier must make. The Department points out that while the Department has authority to list the diseases against which a child shall be immunized, the Department does not have the authority to dictate the manner in which a school chooses to inform parents, guardians and students of those requirements. So long as the requirements are implemented, the Department cannot require schools to act uniformly in implementing them.

 One commentator identified himself as an assistant principal, and stated that he strongly supported any effort that requires students to be immunized to attend school. He stated that he believed in protecting individuals who could not be immunized by immunizing those who can be.

 The Department appreciates the commentator's support.

 Several commentators supported the Department's decision to change the 8-month provisional period, which they felt to be a logistical nightmare for school nurses due to letters and phone calls to parents who do not follow through with the required immunizations. One of these commentators stated that as a public health nurse, and having lived in states with no exemptions except for immediate homelessness and medical reasons, she strongly supported the Department's regulation. She stated that a child should not be allowed to enter school without adequate immunizations.

 The Department appreciates the commentators' support. The Department believes that allowing a child to continue in school with a medical certificate adequately balances the need for up-to-date immunizations for protection of the child and others along with the importance of a child's education.

 One commentator stated that she was in support of the proposed rulemaking, but that she was concerned about the increase in clerical time for the school nurses who will need to review the immunization records before the first day of school. Without a provisional period, the time needed to do this review would be increased. The commentator also noted the need for publicity and mentioned that some small Christian schools have low vaccination rates, so that the amendments will be a big adjustment for them.

 The Department appreciates the support of the commentator, but points out that the provisional period is being reduced, not eliminated. The immunization requirements have not changed in the past 5 years. The Department added one entirely new immunization requirement in this final-form rulemaking, MCV in the 12th grade. Children being immunized against diphtheria and tetanus in this Commonwealth prior to these amendments were receiving DTaP, in accordance with ACIP recommendations (unless the child had a contraindication for the pertussis vaccine or a religious/philosophical exemption) and so are already receiving a pertussis component in their vaccination. As is borne out by the Department's SILR, the majority of students do have up-to-date vaccinations. The Department's hope is that the tightening of requirements will ensure that those parents, guardians and students who simply wait to get immunizations until the last minute will be encouraged to meet those requirements sooner, with less ensuing paperwork and follow-up for school nurses.

 The Department agrees that there is a need for education and outreach on these regulations, and intends to do both with schools, school nurses, health care practitioners, parents and guardians. The Department will ensure that this final-form rulemaking is published prior to kindergarten registration in March 2017, which should provide ample time for information to be given to parents. The Department has already presented the regulations to the State Board of Medicine and intends to continue outreach efforts to health care practitioners on this subject. Finally, with respect to small religious schools, to the extent there is a need, the statutory religious exemption is still in place and may be used, but the Department will ensure that information regarding the change in the requirements is provided to them as well.

 One commentator suggested that children not be permitted to start school until they received the necessary vaccinations, or they received the first dose of a vaccine series, and then the certificates be reviewed every 30 days.

 The Department has not revised the regulation, because this is, in part, what the final-form rulemaking requires. The amendments require a child to have the single dose vaccinations at school entry or face exclusion, although it should be noted that the only single dose vaccine required at the present time is Tdap. In the case of a multidose vaccine, the amendments require that the child have at least one dose of the vaccine upon school entry. If additional doses are required and are medically appropriate within the first 5 days of school, the child shall have either the final dose during that 5-day period, or shall have the next scheduled dose and also provide a medical certificate setting out the schedule for the remaining doses. If the child has at least one dose, and needs additional doses, and those doses are not medically appropriate during the first 5 days of school, the child may provide a medical certificate on or before the 5th school day scheduling those doses. The medical certificate shall be signed by a physician, CRNP or PA. If the child receives the immunizations from the Department or a public health department, a public health official may sign the medical certificate. A child who fails to meet these requirements risks exclusion. This final-form rulemaking requires the schedule of immunizations set out in the medical certificate to be reviewed every 30 days for compliance.

 One commentator stated that all children should have immunizations before attending school, and that there should be no grace period. The 5-day grace period is unrealistic due to the heavy amount of work expected of school nurses at the start of school. According to the commentator, school nurses should be required to come in over the summer to check immunizations.

 The Department has not revised this final-form rulemaking. The Department cannot require school nurses to work over the summer because the Department has no authority over school nurse schedules. The Department addressed the commentator's other concerns regarding the appropriateness of the 5-day provisional period elsewhere in this preamble.

 Two commentators noted that it was difficult to have kindergarten students immunized by the start of the school year because many of the children do not have their 5-year checkups until after the start of the school year. These commentators suggested that it be made standard practice that the fourth and fifth doses of DPT, the third and fourth doses of polio, and the second MMR/V vaccinations be given at the 4-year checkup and not at the 5-year checkup. Since, according to these commentators, all children are 4 years of age when they enter kindergarten, this would eliminate many of those children whose insurance does not cover a well visit until 1 year after the 4-year checkup.

 The Department has not revised this final-form rulemaking. The Department notes that the requirement for a child to be immunized by the start of school has long antedated this final-form rulemaking. The Department cannot dictate how the child's health care practitioner chooses to provide vaccinations to the child, but, as the Department follows ACIP guidelines with regard to setting the immunization requirements for school entry and attendance, the Department assumes that the health care practitioners act in a similar manner. If there is the need for a delay in a vaccination due to a health care practitioner's medical concern over whether or not a vaccination required for school should be given prior to school entry, a medical exemption is available.

Concerns with implementation timeline

 Multiple commentators, including PSEA, PASA, PSBA and IRRC, expressed concern about the final-form rulemaking being effective for the 2016-2017 school year. Several commentators asked when the final-form rulemaking would be effective and what the transition time would be. PSBA and PASA stated that school entities would not have time to develop policies, implement procedures or communicate with parents and guardians about the amendments. PSBA raised concerns about ensuring consistency with information given to current, transfer and newly-enrolled kindergarten students, and ensuring that the information is available in a format other than English for families with limited English proficiency. PSBA noted that this will be a particular issue for the 12th grade MCV requirement, since there are no vaccines currently required for entry into the 12th grade and students in that grade often postpone medical visits to prepare for any medical documentation and additional vaccinations required for college. PSEA stated that, from the perspective of the school nurse, it would be important for schools to develop processes to ensure that the 5-day time frame could be met within the framework of the responsibilities school nurses currently have to carry out during the first week of school. PSEA asked that policy makers consider the challenges for implementation and barriers to compliance that would be presented should the regulations take effect at the start of the 2016-2017 school year. PSBA, PASA, PSEA and other commentators recommended making this final-form rulemaking effective July 2017 or for the 2017-2018 school year. IRRC asked that the Department ensure that the effective date provides sufficient time for school entities to plan, implement policies, and communicate with parents and guardians about the new requirements.

 Several commentators stated that although they are proponents of immunizations, and agreed that children should be immunized to attend school, if the final-form rulemaking were to be effective for the 2016-2017 school year, implementing them would be a difficult task for school nurses. School nurses do not work over the summer and collecting data and informing parents of the requirements would be difficult. School nurses would have to come in on their own time to send letters to parents, make phone calls and type up letters outlining the amended regulations.

 One commentator stated that many less students would be excluded from school if the final-form rulemaking were not implemented until the 2017-2018 school year. This would allow an extra year for parents to learn about the new requirements, and would avoid them getting the information in the middle of the summer and right before children start school.

 After reviewing the comments, the Department agrees with the commentators. The Department expects this final-form rulemaking to be published in time for kindergarten registration for the 2017-2018 school year to enable schools to provide information to parents and guardians regarding the amendments to the regulation, and to give parents of children who have not yet attended school ample time to consult with the child's health care practitioner and obtain the necessary immunizations or exemptions. This should give schools time to develop policies, implement procedures or communicate with parents and guardians about the amendments to the regulations.

 Two commentators asked whether the commentators should send notification to parents of the proposed immunization regulations before the end of the 2015-2016 school year, and if a sample notice was available.

 It was not the Department's intention that the proposed amendments be presented to parents and guardians of school-aged children before completion of the regulatory process, which allows for public comment and discussion. To avoid confusion, particularly in case a regulation is revised or is not approved, the requirements are published as a final-form rulemaking before official notice of new requirements may be provided to parents and guardians. Further, the Department does not intend to provide a sample notice. Communication with parents in this case should be left up to individual school districts.

 PSEA stated that reviewing immunization records and communicating with parents about the need for the second dosage within 5 days could be done but the change would need to go into effect with the establishment of clear systems and protocols to ensure implementation did not overwhelm parents, health care providers, school nurses and school administrators. PSEA stated that, from the perspective of the school nurse, it would be important for schools to develop processes to ensure that the 5-day time frame could be met within the framework of the responsibilities school nurses currently have to carry out during the first week of school. According to PSEA, for school nurses that week is focused on collecting student emergency cards, writing student health plans, reviewing student paperwork for necessary medications, developing emergency plans for students with disabilities, life-threatening food allergies, asthma and other things, and notifying teachers about student health needs.

 The Department agrees with PSEA that it is important for schools to develop processes and communication strategies as it discusses. The Department also notes that, given the fact that the only new immunization added to the list of immunization requirements is MCV in the 12th grade, the number of children lacking all immunizations, or a good portion of those immunizations, should be limited, except in certain schools with low immunization rates. With the Department's decision to change the implementation date of this final-form rulemaking for the 2017-2018 school year, there will be sufficient time for schools and school nurses to develop processes for implementation, for schools and school nurses to provide information to parents and guardians regarding the amendments to the regulation, and for the Department to conduct outreach to schools, school nurses, parents, guardians and health care practitioners.

In favor of a 5-day provisional period

 Several commentators agreed with the Department's proposal reducing the provisional period to 5 days. One of these commentators stated that the 8-month provisional was too long, and that this required school nurses to send multiple written notices and make multiple phone calls to attempt to gather the necessary immunization information. One of these commentators stated that she sends a provisional letter in July of each year, sends a second letter the last week of August, allows 7th graders to start school and after the Labor Day excludes children who are not up to date. The commentator stated that she sends home ten children on average every year, and the next day eight of the ten are compliant. The remaining two may miss 3 to 4 days of school, but they then get their immunizations.

 Another commentator stated that although the change in the provisional period would require additional end-of-the-year groundwork involving 6th graders, it would save an immense amount of time, paperwork and money in the future, including postage and paper.

 One commentator stated that she was aware first hand of the amount of time and money is used dealing with vaccine-preventable diseases and outbreaks.

 One commentator stated that she had been a nurse for the past 45 years, and that if people have 8 months to get appropriately vaccinated, they will take 8 months, and if they have 1 day, they will get vaccinated in 1 day. She stated that if the Department required complete immunization on the first day of kindergarten it would get complete immunization.

 Two commentators stated that they felt parents who do not immunize their children are a bit lazy. Both of these commentators stated that these parents feel no urgency to comply with the law. One commentator suggested if a child could not start school or there was a more realistic deadline to get the immunizations, parents might be more efficient about obtaining immunizations for their children. One commentator noted that parents often use the excuse that vaccines might cause autism. This commentator stated she did not think education would help in this regard, because studies show parents do not understand the benefits of mass immunization, since they have not lived through epidemics of these preventable diseases. She commented that herd immunity needs to be created for the benefit of those who cannot be vaccinated.

 One commentator stated that most of these requirements are already in place in her school district, and that these regulations will merely shorten the time frame.

 The Department appreciates the support of all of these commentators.

 One commentator stated that she supported the 5-day provisional period only if a child may be excluded the day after the proposed second, third or fourth dose of a multidose vaccination is missed.

 The Department appreciates the commentator's support. As the regulation is written, a child may be excluded if the second, third or fourth dose of a multidose vaccination is missed.

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¹⁰  Section 3(b) of the College and University Student Vaccination Act (35 P.S. § 633.3(b)) does provide for religious and medical exemptions.

¹¹  These are brand names of meningococcal vaccines.

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