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

[Continued from previous Web Page]

Comments regarding number of required immunizations

 Several commentators stated that the vaccine schedule has increased over threefold from the mid-1980s, when there were 23 vaccines on the schedule. One commentator stated that there are over 500,000 reports in VAERS, and that these reports include deaths and disabilities. The commentator stated that public health officials claim that the two events are not linked, but that parents of disabled children frequently cite recent vaccination as the catalyst for their children's decline. One commentator stated that it comes as no surprise that children are required to receive an ever increasing amount of immunizations to attend school, since many of government officials also have heavy ties to the major pharmaceutical companies, demonstrating a major conflict of interest to the American people. The commentator stated that in 1983 a child was only required to have 10 vaccines during his lifetime, but in 2013 a child will be required to have 36 to 38 vaccines, nearly 4 times the amount.

 One commentator stated that his children were his to raise, and not the Commonwealth's. He stated that in the 1960s students received around eight vaccines. In the 1980s, students received around 11 vaccines. He stated that the Department was asking parents to allow their children to have 70 plus vaccines, and asked why. He asked whether there was one safety study showing that these vaccines are safe for all children. He stated that children with peanut allergies are not asked to eat peanuts for school lunches. He stated that people react differently to penicillin, and all children should not be expected to be served by one route of prevention.

 One commentator stated that another drug should not be added to the absolutely unprecedented number of vaccines currently on the child vaccination schedule, especially because there was zero data on giving this extremely high number of vaccines to children.

 The Department respects the commentators' views, but disagrees with them. The Department does not adopt the entire vaccine schedule recommended by ACIP, and only adds those immunizations it believes are appropriate for children in this Commonwealth. For example, influenza vaccine is not required for school entry or attendance, although it is recommended by ACIP. In fact, the Department requires ten immunizations for school attendance, and has added only four new immunizations since 1998 (Hepatitis B, varicella, MCV and Tdap). The Department did add a second MMR dose prior to this final-form rulemaking and is now, in effect, requiring a pertussis dose for attendance because ACIP recommendations are to give doses of DTaP and diphtheria and tetanus toxoids and pertussis as a vaccination for diphtheria and tetanus. The Department is also now adding an MCV dose in 12th grade. ACIP recommends many more vaccines for children. However, the Department does not adopt the ACIP recommendations wholesale. The Department reviews ACIP's recommendations and determines which it believes are appropriate for children in this Commonwealth, obtains the approval of the Board and then proposes to add them to the existing list, as it has done in this final-form rulemaking.

 The Department also disagrees that there is no data regarding the safety of providing this number of vaccinations, as discussed in this preamble.

 One commentator stated that the decision to vaccinate should be based on the heavy consideration of factors such as the severity of different illnesses, their speed of transmission and the number of people sickened when weighing their benefits versus their adverse reactions and potential permanent injury. The commentator stated that in current society, vaccines are being overused with mandated legislation being passed very quickly, removing a parent or guardian's right to make informed decisions regarding a child's vaccine schedules and health. The commentator stated that she just turned 40 years of age, and when she was a child, the vaccine schedule for school aged children was shorter than it is now and spaced out so that combinations of different antigens to various diseases were not administered all at once. The commentator noted that more and more childhood vaccinations, including Hepatitis B, rotavirus and HPV, contain genetically engineered components with foreign DNA segments and adjuvants, such as aluminum, capable of triggering autoimmune responses which can contribute to multiple disabilities later on in life, such as allergies and autism. Because of these uncertainties, the commentator is against the Department's proposed rulemaking.

 The Department disagrees with the commentator. The Department, with the approval of the Board, is acting within its statutory authority by promulgating this final-form rulemaking. The Department is not seeking to include all ACIP recommended vaccines for attendance at school. The regulations in this final-form rulemaking do not involve all vaccines available for children, or even all vaccines on the Department's current list of immunizations that are required for school entry and attendance. This final-form rulemaking only adds one dose of MCV in the 12th grade and the de facto requirement of pertussis for school attendance because of the unavailability of single antigen vaccines.

 The Department agrees with the commentator that severity of illness, speed of transmission and safety of the immunization should be considered in deciding whether or not to require an immunization for school entry and attendance. The Department does take all this into account, and considers the advice of experts on staff, the Board and recommendations made by ACIP. ACIP, which is a committee made up of physicians and scientists with extensive experience in the field of infectious disease, immunology and vaccine research, performs a cost-benefit analysis, makes determinations of how to use vaccines and then issues recommendations. See Vaccines: What You Should Know, p. 24. The Department also considers the FDA's decisions to license vaccines. The FDA reviews vaccines to determine whether or not to license them, and considers the safety of the vaccine and its efficacy. See Vaccines: What You Should Know, p. 24. Neither the FDA nor ACIP requires that a child be given immunizations. The Department, based on the authority given to it by the General Assembly, and with the approval of the Board, has the discretion to review these determinations and decide what will be added to the list of diseases and conditions against which a child should be immunized.

 The Department notes that the MMR vaccination and a requirement for immunization against hepatitis B are already in place. The MMR is only the subject of this final-form rulemaking to the extent that the Department rewrote the requirements to acknowledge that, in the United States, the vaccine is given as a combination vaccine. Because single antigen vaccines are still available outside of the United States, the Department left that requirement in this final-form rulemaking to account for the possibility that a child could enter school from another country with single antigen vaccines.

 The Department is also not requiring a rotavirus immunization or an HPV immunization for school entry or attendance, although both are recommended by ACIP. The Department also agrees that several immunizations have been added to the list of required immunizations since the commentator was a child. When the commentator was at school age, in the early 1980s, several of the required immunizations were not available. For example, the varicella vaccination was not licensed in the United States until 1995, and was not added to the list of required immunizations until 1998. Vaccines against meningitis only became available in the mid-2000s. The Department addressed the reputed link of the MMR vaccine to autism previously in this preamble.

 One commentator stated that researchers have shown that waning immunity is a problem with vaccines and diseases that previously occurred in children, so that the outbreaks are pushed off to a later date in older individuals, when they are more serious. The commentator stated that perhaps the Department should investigate ways to increase a healthy immune response instead of promoting more and more vaccines.

 The Department disagrees with the commentator. Vaccine efficacy is still high regardless of waning immunity in some vaccines. No vaccine is 100% effective. Even if immunity wanes, as, for example, with pertussis, the vaccinated child is less likely to contract the disease, and is still protected against the most severe case of the disease.

Unvaccinated children have at least an eightfold greater risk for pertussis than children fully vaccinated with DTaP. . . .Although vaccinated children can develop pertussis, they are less infectious, have milder symptoms and shorter illness duration, and are at reduced risk for severe outcomes, including hospitalization. . . .[V]accination continued to be the single most effective strategy to reduce morbidity and mortality caused by pertussis.

See ''Pertussis Epidemic,'' p. 4.

 Several commentators stated that medical ''experts'' disagreed over vaccine safety and effectiveness, and that many studies that were done were epidemiological in nature, where data can be manipulated to show whatever one wishes to show. The commentators stated that few people believe that pharmaceutical companies are ethical or have the best interests of the public at heart, the opposite is true. The commentators stated that no one should be required to accept their products when one knows they are criminal (remember VIOXX). According to the commentators, it has been proven that the CDC has close contacts to pharmaceutical companies, and that ''Vaccinate Adults,'' a newsletter published by the Immunization Action Coalition, condones and promotes increasing vaccine rates among adults. The commentators pointed out that the major supporters whose generosity they appreciate are eight drug companies and that the CDC is their primary supporter. The commentators asked how anyone can ever think the CDC is truly in the business of controlling diseases and most especially controlling them for children.

 The Department disagrees with the commentators' views, but is not in a position to convince them otherwise. The commentators have a particular viewpoint with regard to the motives of pharmaceutical companies, epidemiologists and the CDC. The Department is charged by the General Assembly with making decisions regarding which immunizations are required for school-aged children to protect them and the public's health. The Department has been carrying out this function for many years to the best of its ability and with great care for the safety of the children of this Commonwealth. The Department reviews and has relied upon the opinion of ACIP.

 ACIP 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. ACIP does not include any person who is currently employed by or involved with employees of vaccine manufacturing companies or who holds a patent for a vaccine. In addition, ACIP includes ex officio members from Federal agencies involved with vaccine issues and nonvoting liaison representatives from medical and professional societies and organizations. Smith, J. C. (2010), ''The Structure, Role, and Procedures of the U.S. Advisory Committee on Immunization Practices (ACIP),'' Vaccine, 28(S 1), A68—A75, retrieved from https://www.cdc.gov/vaccines/acip/committee/downloads/article-2010-role-procedures-ACIP.pdf. ACIP's charter states:

The committee shall provide advice for the control of diseases for which a vaccine is licensed in the U.S. The guidance will address use of vaccines and may include recommendations for administration of immune globulin preparations and/or antimicrobial therapy shown to be effective in controlling a disease for which a vaccine is available. Guidance for use of unlicensed vaccines may be developed if circumstances warrant. For each vaccine, the committee advises on population groups and/or circumstances in which a vaccine or related agent is recommended. The committee develops guidance on route, dose and frequency of administration of the vaccine, associated immune globulin, or antimicrobial agent. The committee also provides recommendations on contraindications and precautions for use of the vaccine and related agents and provides information on recognized adverse events. Committee deliberations on use of vaccines to control disease in the U.S. shall include consideration of disease epidemiology and burden of disease, vaccine efficacy and effectiveness, vaccine safety, economic analyses and implementation issues. The committee may revise or withdraw their recommendation(s) regarding a particular vaccine as new information on disease epidemiology, vaccine effectiveness or safety, economic considerations or other data become available.

The committee also may provide recommendations that address the general use of vaccines and immune globulin preparations as a class of biologic agents. These general recommendations may address principles that govern administration technique; dose and dosing interval; recognized contraindications and precautions; reporting adverse events; correct storage, handling, and recording of vaccines and immune globulin preparations; and special situations or populations that may warrant modification of the routine recommendations.

In accordance with Section 1928 of the Social Security Act, the ACIP also shall establish and periodically review and, as appropriate, revise the list of vaccines for administration to children and adolescents eligible to receive vaccines through the Vaccines for Children Program, along with schedules regarding the appropriate dose and dosing interval, and contraindications to administration of the pediatric vaccines. The Secretary, and as delegated the CDC Director, shall use the list established by the ACIP for the purpose of the purchase, delivery, and administration of pediatric vaccines in the Vaccines for Children Program.

Further, under provisions of the Affordable Care Act (Section 2713 of the Public Health Service Act, as amended), immunization recommendations of the committee that have been adopted by the Director of the Centers for Disease Control and Prevention must be covered by applicable health plans.

 Retrieved from http://www.cdc.gov/vaccines/acip/committee/charter.html. The Department's own experts review ACIP recommendations, considering the unique needs of the children of this Commonwealth and with the approval of the Board, as required by law, determines to add those immunizations to the list that it believes are necessary for that protection.

Comments regarding communication of proposed rulemaking

 Several commentators asked whether the proposed rulemaking was communicated to family practice doctors and pediatricians in this Commonwealth. One commentator stated she had heard many doctors' offices were not aware of the proposed rulemaking, and asked what was being done to inform them so that they do not become a barrier to care. Several commentators recommended that the Department educate new and existing health care practitioners regarding the school immunization requirements, because in her opinion some licensed practitioners were not familiar with them. One commentator expressed concern that in her experience immunizations were being given on the wrong schedule. One commentator stated that physicians would have to play a major role in implementing this final-form rulemaking.

 Several commentators recommended educating parents as well as health care practitioners and school staff. One commentator stated that she hoped the general public would be educated as well as physicians and their offices.

 PSEA and several other commentators expressed a need for education of the groups impacted by this final-form rulemaking. PSEA recommended that the Department do an educational campaign for parents, schools and health care providers that administer immunizations, including pediatricians, family physicians, internists, CRNPs, pharmacists and health clinics. PSEA recommended that the campaign include model guidance and educational materials that schools can use for educating parents about vaccine requirements, provisional periods, exceptions and reporting. PSEA recommended that the training for providers, including support staff, include medically sound information about the revised immunization requirements, schedule and timing of shots, and indications and contraindications, as well as best practices for maximizing patient contacts, including acute office visits for minor illnesses, to keep a child's immunizations current.

 The Department agrees that education of health care providers and practitioners that provide vaccines, including pharmacies, regarding these requirements would be useful and helpful, and will reach out to stakeholders and medical organizations for this purpose when this final-form rulemaking is approved. The Department will ensure that the immunization requirements are made available to schools prior to kindergarten registration, which begins in March 2017, so that all affected persons are aware of the new requirements 5 to 6 months before the start of the 2017-2018 school year.

Comments regarding HIPAA and the sharing of immunization information between physicians and schools

 Several commentators who identified themselves as school nurses stated that doctors' offices refuse to provide immunization records to school nurses, claiming that it was a violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub.L. No. 104-191). Two commentators stated that it would be helpful if HIPAA did not apply between doctors' offices and schools, because it would be helpful to get records directly from doctors' offices instead of having to depend upon parents who do not follow through with obtaining the required information. One commentator stated that she had actually excluded a student from school who had already had a vaccine but the doctor refused to send her the record, and the parent refused to pick up the record at the doctor's office. She did not find out that this is why the child's record indicated the child did not have the vaccine until after the exclusion had occurred, but she found the situation to be ''just ridiculous.''

 One commentator recommended that the Commonwealth allow for the free exchange of immunization records between school nurses, doctors' offices and health clinics without the need for a medical release and that doctors' offices should be required to comply with this ''mandate.''

 PSEA and several commentators strongly supported the Department's Statewide Immunization Information System (SIIS) as a very useful tool to allow for sharing of information between health care providers and schools. SIIS allows for the voluntary participation of providers to report immunization delivery in an electronic information system. PSEA encouraged the Department to determine effective strategies to increase physician and health care provider participation and utilization of SIIS. PSEA noted that central collection of the immunization information would help address some health care providers' hesitation, based on HIPAA and privacy concerns, in sharing immunization information with schools without parental consent.

 Several commentators recommended that persons authorized to administer immunizations should be required to record immunizations given in SIIS. One commentator noted that a school nurse could look in SIIS to find the immunizations and would be able to concentrate on students who do not have the necessary immunizations. One commentator recommended that general and pediatric practitioners need to make sure that all vaccinations given at the 4th year well baby visit are entered into SIIS. The commentator stated that it did not appear that licensed practitioners are familiar with mandated school immunizations. The commentator noted that if the immunizations were given and put into SIIS, the school nurses would at least be able to locate them and avoid many phone calls, unanswered certified letters and attempts to enforce compliance through education, which many parents have already had, as well as threats of exclusion. Another commentator stated that many times the child has the immunization, but the school nurse does not have the proper documentation. The commentator stated that parents are often charged a form fee when they request a print out of their children's immunization records at a time other than at the regular well child checkup. SIIS would eliminate this issue.

 Two commentators expressed surprise and frustration that more practitioners did not use SIIS and input all immunization data into it. One of these commentators suggested a monetary fine might force practitioners to participate. She stated that physician participation in SIIS was a critical component for stricter provisional enrollments to be enforced.

 PSEA and another commentator noted that it made sense to use an electronic system, since children who were homeless or who switched schools frequently would always have their electronic immunization information available, whatever school district they were in.

 One commentator recommended that the Department strongly consider a Statewide system of online school-based charting for kindergarten to 12th grade to which all school nurses would have access. According to the commentator, this is the only way to seamlessly track the health of students in this Commonwealth. She recommended that new students be immediately entered upon registering in schools, and parents, or in the case of children in the custody of Children and Youth, the Children and Youth Worker responsible for the child, should be required to sign a release. The commentator stated that at the present time, they do not always receive records from schools out-of-State or from school districts in this Commonwealth because children move around.

 While the Department understands the frustration of school nurses over the difficulty in obtaining immunization information, the Department cannot change the requirements of HIPAA, which is a Federal law. Health care providers are legally correct in hesitating to turn over immunization information to schools without parental consent. The Department understands the need for an option that provides immunization information more quickly. HIPAA does have an exception for public health programs, including reporting programs. If the Department were to add a section to Chapter 27 (relating to communicable and noncommunicable diseases) requiring reporting of vaccine administration to the Department's SIIS, this could address the concerns raised by school nurses on this issue. The Department has the authority to do so under the Disease Prevention and Control Law of 1955. This action would require a separate rulemaking.

 The Department agrees that no child should be required to be revaccinated or excluded from school if there is a record that is obtainable. The only way the Department can eliminate the need for a consent under HIPAA to transfer personal health information is for the Department to bring the requirement for provision of the information under the public health laws of the Commonwealth. Reporting to SIIS is voluntary. The Department cannot set up a system for school health records.

 One commentator stated that vaccinations are a medical procedure and do not belong in a virtual database. This is a violation of privacy and HIPAA laws. The commentator stated that it was no wonder physicians were not entering their vaccination records there. The commentator stated that this played right into the vaccine industry's billion dollar business of using the government to force their agenda of more vaccines on children. Neither the Commonwealth nor the Federal government has the right to have citizens' medical records in their databases.

 As the Department has stated, use of SIIS is voluntary and does not require reporting of student identifying information to the Department. Information reported by schools to the Department under § 23.86 (relating to school reporting) does not contain student names or health records. Under § 23.86, schools report aggregate data to the Department, for example, numbers of immunizations by type and in certain years. No identifying information is passed between the school and the Department through the SILR. The Department does have SIIS, its vaccine registry. As has been stated, reports to SIIS by providers are voluntary, and the only information included in that registry comes from providers who have obtained the appropriate consents from their patients to include that information in the Department's system. There is no HIPAA violation.

 Should the Department choose to promulgate separate regulations requiring the reporting of vaccine delivery by persons administering vaccines, the Department has the authority to do so. See section 3 of the Disease Prevention and Control Law of 1955 (35 P.S. § 521.3), section 16(a)(6) and (b) of the Disease Prevention and Control Law of 1955 and Section D of this preamble. If vaccine delivery does, at some future time, become a reportable disease, infection or condition under the Disease Prevention and Control Law of 1955, the information in SIIS going forward would be protected under the confidentiality provisions of this law. The Department would be prohibited from releasing that information with three very limited exceptions: upon the consent of the individual; for research purposes under Department supervision; and if the Department determines that to release the information would further the prevention and control of the spread of disease. See section 15 of the Disease Prevention and Control Law of 1955 (35 P.S. § 521.15). Because HIPAA contains a public health exception in these instances, there would be no HIPAA violation. See 45 CFR 164.512 (relating to uses and disclosures for which an authorization or opportunity to agree or object is not required).

Comments regarding insurance coverage for immunizations

 One commentator stated that the cost for vaccinations needed to be covered by the parent or guardian's health care insurance, or some form of Statewide health care. The commentator stated that the cost could not be passed on to the schools.

 The Department appreciates the commentator's concern regarding cost. It was not the Department's intention that the cost of the vaccinations be passed on to schools. If a school elects to request participation in the Department's School Immunization Catch-Up Program, the school is provided the vaccine by the Department, free of charge.

 One commentator asked what the required immunizations were for children in pre-kindergarten through 12th grade.

 The list of diseases against which children shall be immunized to attend school is in § 23.83, which is amended in this final-form rulemaking. The list of diseases against which children attending a child care group setting shall be immunized are in § 27.77 (relating to immunization requirements for children in child care group settings). That list will not be impacted by this final-form rulemaking.

 One commentator asked whether the Department would provide clinics over the summer for students to get the required immunizations since doctors' offices might not be able to accommodate the increase in number of children seeking vaccinations.

 One commentator stated that she knew the Department was increasing clinics to get children vaccinated, but said she could not understand why these were only open to those children who did not have health insurance or whose insurance did not cover vaccinations. The commentator stated she thought it would be more helpful if the clinics were open to all who felt they needed an alternative.

 The Department no longer has the ability to run clinics for all children due to changes in Federal funding requirements that limit the provision of the vaccine the Department obtains through its Federal grant to uninsured or underinsured children (that is, children whose insurance does not cover vaccines) or because they are American Indian or Alaskan Native. See sections 1902(a)(62) and 1928 of the Social Security Act. Schools may apply for the Department's School Immunization Catch-Up Program, which provides VFC Program vaccines to eligible children.

 One commentator asked what the role of the Department of Health would be and whether school nurses could send students to State health centers if they had insurance.

 One commentator stated that there was a State health center within 10 miles of the commentator's school, but noted that families still lack transportation and other resources to access the State health center. The commentator noted that her school district was rural and covered over 224 square miles. The commentator questioned how the proposed rulemaking would help those families.

 The Department cannot immunize children who are insured, so the ability of an insured child to access a State health center does not impact the regulations. By law, the vaccine received by the Department through its Federal grant through the Federal VFC Program may only be given to children who are uninsured and underinsured, or meet one of the program's other eligibility requirements. Under that program, the Department may give vaccine to schools if there is a need to catch up the VFC-eligible children in the school's population. Any school may apply to the Department for vaccine for this purpose. There are VFC Program providers throughout this Commonwealth. In addition, a child who is eligible for the VFC Program may also obtain vaccine at a Federally qualified health center (FQHC). The Department also administers vaccine to VFC Program-eligible children in most of its State health centers through agreements with FQHCs. The Department has a list of these FQHCs and VFC Program providers, and can provide that information to a parent or guardian with a VFC Program eligible child seeking to find a provider.

 One commentator asked how parents were to pay for the immunizations if an insurer claimed the child's coverage would not cover the immunizations before the start of the school year. The commentator stated that she received calls on many occasions that an insurer would not cover the visit until after the start of the school year.

 Under the Patient Protection and Affordable Care Act (ACA) (Pub.L. No. 111-148), enacted March 23, 2010, an insurer is required to cover all immunizations recommended by ACIP. See section 2713(a)(2) of the ACA (42 U.S.C.A. § 300gg-13(a)(2)), regarding coverage of preventative health services. Failure to do so is a violation of the law. The immunizations required for school attendance by the Department are ACIP recommended vaccinations. Both the health care practitioner and the parent should be aware of the insurance coverage, and plan to receive the required vaccinations in accordance with the Department's requirements and their insurance coverage. Delay in obtaining the vaccinations could create problems.

General comments

 One commentator asked what steps a school nurse should take if a child did not comply with mandated health screening. The commentator stated that some parents will turn in forms that state that the children will have a private dental or physical examination, and then turn nothing in.

 This final-form rulemaking does not deal with mandated health screenings. Questions regarding those screenings should be directed to the Department's Division of School Health.

 One commentator stated that she hoped the Department would have a sufficient supply of vaccine available to accommodate the new requirements.

 The Department does not anticipate any vaccine shortages in the near future. The Department no longer provides vaccine to the general public and would only make vaccine available for children eligible for the VFC Program.

 One commentator asked whether the Department would provide a form letter to send home to kindergarten students currently in a provisional status if the regulations were effective for the 2015-2016 school year. The commentator also asked whether there will be a form letter available for future kindergarten students.

 This final-form rulemaking will be effective August 1, 2017. Publication of this final-form rulemaking is expected to be in time for registration for the 2017-2018 school year to enable schools to provide information to parents and guardians regarding the amendments to the regulations. The Department will not be providing a form letter.

 Two commentators raised issues about children with late summer birthdays or who are ''young for their grade.'' One commentator stated that she had taken her son for a physical required for entry into 6th grade, but the doctor would not give him his immunizations because he was not yet 11 years of age. He was 13 days from turning 11 years of age and had to make a return trip to the doctor's office. The commentator noted that there are children who have skipped grades or have moved from areas where school start dates are different, which places them in a pocket of not being able to receive the vaccine and then not being able to go to school. The commentator noted that medical immunizations are based on age, while school immunizations are based on grade, which causes problems with compliance. One commentator asked that a delay exemption be added to the regulations so that children who enter school early, or who advance more quickly, are not forced to receive vaccinations at an accelerated rate relative to their biological age if the medical recommendations for their biological age conflict with educational requirements.

 The Department is not aware that the immunization requirements would conflict with the possible age of a child entering school. Most vaccinations necessary for school entry and attendance are licensed for a child younger than 5 years of age, and, therefore, school entry and attendance is not an issue. The same applies for a child at entry into 7th grade. There is no issue with respect to Tdap and the first dose of MCV is recommended at 11 to 12 years of age. If there were to be an issue with an exceptionally accelerated child, the medical exemption is available for use. With respect to the commentator's son, there is a 4-day grace period built into the regulations, that is to say that a child receiving a vaccination within 4 days of the minimum age for vaccination may be counted, but a dose given further than 4 days before may not. See § 23.83(f). The Department encourages parents to take this into consideration when seeking immunizations.

 One commentator stated that he was very concerned because he did not understand how the Department and the Department of Education had overlapping duties and roles. He stated that the Department of Education was to educate and the Department was to keep this Commonwealth safe. According to the commentator, only when a wild virus might happen should the Department be involved in local schools. The commentator stated he thought it was ''really weird'' when the Department and the Department of Education have joined the CDC as the experts, in the jurisdiction of medicine, dictating to children, families and health care practitioners what to ingest and inject and when to do so. The commentator recommended that the Department read an article in on the Washington Post web site posted on May 3, 2016, ''Researchers: Medical Errors Now the Third Leading Cause of Death in the United States.'' He also asked that the Department look at the top ten causes of death, stating that only one cause, the flu, can possibly be prevented by vaccination, and those deaths usually occur in the elderly and not in school-aged children.

 The Department agrees with the commentator insofar as the Department's intention is to keep this Commonwealth safe and healthy. The Department disagrees that childhood diseases cannot be prevented by vaccination. Vaccination has prevented disease and death among children and will continue to do so. See ''Benefits from Immunization.'' Falling disease and death rates in measles, mumps, rubella, diphtheria and other diseases bear this out as well. See Pink Book, Appendix E.

 With respect to the comment that the Department has made itself an expert, the General Assembly has provided the Department with the legal authority to set the list of diseases against which children shall be immunized to enter and to maintain attendance at schools. See Section E of this preamble. The Department and the Department of Education share responsibilities in schools, as it is for school administrators to enforce the requirements set out by the Department under the Public School Code of 1949, unless there is an unusual expression of illness or any type of disease outbreak. The Department's authority to prevent and control the spread of disease in public and private schools is specifically set out in section 3 of the Disease Prevention and Control Law of 1955. Parents and guardians with strong objections to the regulations may still seek a medical or religious/philosophical exemption to obtaining an immunization, but in the event of a disease outbreak necessitating isolation or quarantine measures, or measures involving exclusion of persons not adequately vaccinated, an unvaccinated child will be excluded from school. See Chapter 27, Subchapter C (relating to quarantine and isolation) and sections 5, 7 and 11 of the Disease Prevention and Control Law of 1955 (35 P.S. §§ 521.5, 521.7 and 521.11).

 One commentator recommended that everyone in a position of authority to change vaccination laws should watch ''VAXXED: From Cover-up to Catastrophe'' and get educated as to what is really going on. Another commentator recommended that everyone should see ''VAXXED: From Cover-up to Catastrophe,'' which is a very important documentary. The commentator stated that this is not an anti-vaccination documentary, it is a documentary explaining a CDC fraud regarding the MMR vaccine. The commentator stated that locations where the documentary are playing are limited because the pharmaceutical/vaccine industry is doing everything they can to keep this out of the mainstream.

 One commentator asked that the Department hear the cries of concerned mothers from this Commonwealth who oppose the proposed amendments to current vaccination policy.

 The Department understands that some parents are concerned about the efficacy and safety of vaccines. As previously noted, vaccines, like medication, can cause side effects, and no vaccine is 100% effective. The most common side effects are mild, but many vaccine-preventable diseases can be serious, or even deadly. Although many of these diseases are now rare in the United States, they are present in other parts of the world and can be brought into this country, putting unvaccinated children and adults at risk. The Department recommends that parents talk further about their concerns with their children's primary care physician.

Comments opposing imposition of school vaccine requirements in violation of parental and human rights

 Multiple commentators opposed what they considered to be mandatory vaccination in general, provided anecdotal reasons why requiring immunizations was illegal and immoral, and a violation of individual rights. The Department has detailed those comments as follows, and then provided a response to all of the comments.

 Multiple commentators stated that parents should have rights to make decisions for the best interests of their children and about their children's health, including whether or not to vaccinate their children. One commentator was opposed to government regulations interfering in the choices of the commentator's health concerns. One commentator stated that it was a violation of human rights to force vaccines on people. One commentator opposed changes to vaccine policy that interferes with a parent's God-given right to make medical decisions for their children. The commentator stated that informed consent is a priority. The commentator opposed an increase to the number of vaccines currently on the childhood schedule and opposed adding more vaccines as a requirement for school. One commentator said that one size fits all is not a safe policy. One commentator stated that it was a disgrace to have that right taken from parents. The commentator expressed the belief that this was headed toward socialism. The commentator prayed that the Department take the time to listen to the voice of the people, and defend the rights of parents and citizens of the United States. The commentator stated that this was not about vaccinations, but about government control of personal rights, and where rights and freedoms lie, with citizens or with government officials.

 One commentator stated that she completely opposed the mandatory vaccine requirement for all school-aged children. The commentator stated that these policies are unconstitutional, and that the Department, the Department of Education and individual schools will be subjected to massive future liability as there is increasingly more evidence past and present, being exposed by individuals across multiple spectrums and disciplines within and without the medical and scientific communities of the injury and death caused by vaccines. The commentator stated that by removing an individual or parental right to take responsibility for their own or their children's health, these entities are taking on full responsibility and liability for this child's health and any injury or death that may occur due to these mandates. The commentator stated that the Department, the Department of Education and individual schools for all levels of education are placing themselves in an extremely liable position of not giving parents and college students true informed consent. The commentator stated that the current illegal, unconstitutional practice of the these entities threatening, bullying, coercing, administering vaccines without signed informed consent and misinforming (deceiving by downplaying and omitting risks and alternatives to vaccines) parents and students into vaccinating to attend any educational institution, public or private, must be stopped. The commentator stated that vaccines cause injury and death as even the Federal government acknowledges. The commentator asked that the Department be informed, and defend the constitutional rights of the citizens of the United States and the residents of this Commonwealth. The commentator stated that this was the citizens' inalienable right. The commentator stated that she respected science, and that while people lie, that science never lies. People manipulate data. Science never manipulates data. She stated that people compromise for gain, science never compromises for gain.

 One commentator stated that it is very important to the commentator's family and other families that elected officials uphold a family's right to decide what is best for the family's children, including choices involving vaccines: whether, when and which vaccines to give the child. The commentator stated that the list of vaccines continues to grow, and parents must have the right to decide whether or not the list and schedule are what is truly best for children in this Commonwealth. The commentator appreciated the Department working to ensure parental freedoms were not compromised.

 One commentator stated that she was very concerned that the proposed rulemaking would compromise the commentator's rights as a parent to provide the commentator's child with proper medical care and might even be dangerous to the children affected by the amendments.

 One commentator stated that it was not the government that would be living with death or mental or physical disabilities that the vaccination might cause, and that the loss was bad enough, but no one could be sued for the loss.

 One commentator stated that many people have deep personal convictions and religious beliefs that are strongly against vaccination, and many children have reactions to them. According to the commentator, taking parental choice out of vaccination is wrong. The choice of whether the commentator wants these inoculations is a basic human right.

 Several commentators supported comments provided by PACIC. One commentator stated that it was the inalienable right of citizens in a free country to maintain informed consent for all medical procedures, including vaccines.

 One commentator stated that the Department should not take her God-given right to choose for her child away from her or her family. The commentator stated that some vaccines have been banned in other countries, and forcing these on kids against the will of the parent should be illegal, but the Department is trying to legalize it and say it is helping. Too many people die from these vaccines to say this is helping. The commentator stated that no one should be forced into receiving an injection or procedure of any kind that they or their parent or guardian does not agree with, especially when the injection contains known carcinogens, neurotoxins, and animal or fetal tissue, or both.

 One commentator stated that she valued the opportunity to be an active voice on behalf of children, and for ourselves as members of a country unique in the world for its enshrined defense of individual conscience and religious conviction.

 One commentator stated that the citizens of the United States have medical freedom, freedom over their own bodies, without fear of losing the privileges of citizenship, like education or employment. The commentator stated that vaccines are a medical intervention involving risk, and the right to opt out of them must be maintained. Because it is unknown how sensitive a child or adult might be to a vaccination, the right to opt out of them must be maintained. This is a very basic human freedom and must be preserved. The commentator stated that this is a vital matter that concerns every parent and child in this Commonwealth and should be fully publicized so that citizens may give input to their legislators. The commentator urged the protection of parental choice.

 One commentator stated that this Commonwealth was not a third world country, and that there was only one single reported measles case in this Commonwealth last year. The commentator stated that there was absolutely no threat to the public's health. The commentator stated that adding more questionably safe vaccines to the mix is pointless and expensive. The commentator stated that above all it is imperative that a parent decide their child's health, and not some bureaucrat. The commentator stated that vaccines can and have injured children. The commentator stated that unvaccinated children pose no more threat than vaccinated children. The commentator was personally aware of several children who are exceptionally healthy and intelligent and have never had a vaccine through childhood. The commentator counts himself as one of many that live productive lives without vaccines, boosters or prescription drugs. The commentator asked that parents be allowed to exercise their human rights to raise children in their own way. The commentator stated that vaccines are not for everyone just as prescription drugs are not for everyone, and that everyone deserves a choice.

 One commentator opposed the proposed rulemaking in solidarity with a friend whose life had been affected by a routine vaccination, and to amplify her words.

 One commentator stated that given links of problems to vaccines and the unreliability of the CDC to conduct unbiased studies, no additional vaccines should be mandated.

 One commentator stated that there is much concern over vaccines right now due to the number and type of vaccines that are being given to babies and young children. The commentator stated that more and more information and research is coming out every day and people are starting to become educated on what they are injecting into their children. The commentator asked that the Department slow down changes and additions to the vaccine policy for young children. The commentator stated that we must take responsibility for the safety of children in this Commonwealth because the vaccine manufacturers do not.

 One commentator stated that there should be no further mandates pushed on the citizens of this Commonwealth without the provision of choice based on the negative side effects the vaccines could have.

 One commentator stated that the proposed rulemaking should be withdrawn and no additional vaccine mandates be issued.

 Several commentators stated that they had done intensive research on vaccines and their effects. One commentator stated that from her research she had ascertained that today's vaccines contain ingredients which are highly toxic synergistically or alone, or both. The commentator stated that vaccines cause life-long autoimmune disease, such as autism, paralysis pain and death, and they are usually ineffective. The commentator stated that people have been given a highly effective immune system, and vaccines make it less effective. She stated that she has many friends who have received the flu vaccine which is full of toxic mercury and then have come down with the flu in 3 weeks. The commentator stated that vaccines should never ever be mandated. The commentator stated that this was a gross violation of the Fourth Amendment to the United States Constitution. The commentator stated that the sale and use of vaccines is a crime against nature solely for the profit of big pharma.

 HSLDA commented that the law should generally defer to a parent's right to make medical decisions for a child.

 Two commentators stated that it was a violation of human rights to force vaccines on people. Vaccinations should be recommendations and not requirements. Vaccinations are medical treatments with serious risks that should be a private matter between patients and doctors, and should only be administered by family doctors and pediatricians in their offices, and not in drug stores or schools. The commentators stated that schools should not be allowed to ask for medical information, such as vaccination status. The commentators stated that if it is not permissible to discriminate against people who have communicable diseases like AIDS, hepatitis or herpes, then no one should discriminate against disease-free people and prevent them from keeping jobs or attending school because of vaccination status.

 One commentator stated that it was wrong and unethical to strip Americans of their freedom to make decisions regarding medical procedures for themselves and their families. The commentator asked that the Department withdraw the proposed rulemaking and not issue mandates regarding vaccinations.

 One commentator stated that she prided herself on teaching her chiropractic patients about true health to take charge of their health and the health of their families. According to the commentator, a large part of this involves having the right to choose what medical procedures are best given the specific health needs of the family. The commentator stated that she had made it her life's work to better understand the human body and how to restore and maintain health, and that she was appalled that the Commonwealth wants to completely strip the individual's freedom to choose what is best for the individual's family. The commentator stated that she had spent more time studying to understand vaccinations than most politicians who are often blinded by the truth given their political positions.

 One commentator stated that parents care more about children than life itself. They should be able to make informed decisions. The commentator asked that no more laws be passed to ''keep us safe.'' The commentator stated that the United States is the ''land of the free,'' not land of the legislated.

 Another commentator stated that every child has a right to a free and public education without discrimination for not having a dangerous procedure—vaccinations. The commentator stated that vaccines have serious side effects and are known to actually shed the diseases they supposedly protect persons from. Outbreaks like the one in California occur in populations that are 100% vaccinated. According to the commentator, there is an urgent need to require legal protection of parental rights regarding medical and religious exemptions to vaccinations for minor children. The commentator stated that she was proud to have been born and raised in this Commonwealth, and she would be saddened to have this Commonwealth known for restrictive and unjust amendments to the law on vaccines.

 One commentator stated that parents who interact with their children daily are more adept to make medical decisions than medical doctors who see children for 15-minute to 30-minute well child annual visits. The commentator stated that herd immunity debases the individual needs of each child of all races. The commentator believed that some immunizations are an effective means of keeping children healthy. The commentator stated that they chose to immunize when their children are otherwise healthy. The commentator stated that they chose to spread out their immunizations, ten immunizations at one time is unhealthy. The commentator stated that they respect other parents' decisions not to immunize their children. The commentator stated that the number of immunizations demanded in today's world is disconcerting. The commentator stated that antibiotics exist in today's world which quickly heal. The commentator stated that her nephew had seized after immunizations. The commentator stated that friends have children who, after the chickenpox vaccine, have developed severe allergies, lameness and hearing loss. The commentator stated that a parent whose child adversely reacts to an immunization is legally and morally responsible for the child's well-being. Because of that responsibility, the parent should be able to make the choice.

 One commentator stated that there are too many questions without answers regarding vaccine safety. The commentator stated that there are recalls, failures and many are for diseases that would not cause great danger to the public. The commentator stated that vaccines need to remain a personal decision because they are not safe for all people and therefore cannot be required of all.

 One commentator stated that people deserve the right to deny vaccinations under the United States Constitution. The commentator requested that the Department represent the citizens of this Commonwealth as it should. If the Department were to read the ingredients in the vaccinations, it would know they were not safe for humans.

 One commentator stated that she homeschooled her seven children, three of whom she adopted from China, which has decided it knows what is best for its families—the two-child policy, which causes millions of baby girls to be abandoned every year. She stated that she adopted these three children in an effort to protect, love and provide a home for them, and she is working for the parental rights of all parents to do that. She stated that the United States has always been regarded as the land of liberty, and was founded on the principles of individual liberty and self-government. She stated that more and more the rights of American parents to direct the care and upbringing of their children is being lost. She stated that it is the function of government to protect individual liberty and prosecute crime, and the rights of good parents, who know and love their children best, should be protected and not infringed. She stated that to assume the government knows best how to raise children is to assume that it has some superior intelligence or ability. The commentator asked that if the decisions made by people are so bad that it is not good to permit people to be free, how is it that the decisions made by legislators are always good. She asked whether legislators belonged to the human race. She asked whether the Department believed that if left undirected, mankind would destroy itself because the people's ability to self-govern is inadequate. She asked whether the Department believed that it had a superior intelligence that placed it above them. She asked that the Department give up its idea of forcing parents to acquiesce to the latest vaccination requirements. Not only are they oppressive and unjust, they imply that the government thinks it is infallible and parents are incompetent. The commentator stated that parents are not required to immunize their children until they are admitted to school, and this should be left unchanged. She asked that the rights of parents to raise and direct the upbringing of children in the way the parent believes is right be protected.

 One commentator stated that the Federal government has shielded the vaccine industry from effective oversight and liability, and that horrific scandals continue to emerge. The commentator stated that the public has been willfully misled about ''vaccine safety and effectiveness,'' as succeeding generations continue to suffer permanent injury and death. The commentator stated that in this decades-long battle for the truth, people who share her beliefs state that ''vaccines should not be mandated, vaccines should be banned.'' She provided ten reasons why this was the case, and included links and citations to articles supporting these positions, as well as additional information, movies, videos and books regarding vaccine dangers, vaccine reaction symptoms:

 (1) Vaccines cause catastrophic and permanent damage and death. The commentator stated that total compensation from the Vaccine Court over the life of the VAERS program was $3.3 billion, that since 1988 over 16,878 petitions have been filed with the VAERS program but only 4,582 of those were determined to be compensable. The commentator stated that the flu vaccine is the most dangerous shot in the United States, and in June 2014, a report covering a 3-month period shows that 78 cases were awarded settlements for vaccine injuries, with 55 being for the flu shot, including 1 death. Flu vaccine injuries include GBS, chronic inflammatory demyelinating polyneuropathy, rheumatoid arthritis, shingles, brachial plexus neuropathy, Bell's palsy, brachial neuritis, transverse myelitis, lichenoid drug eruption and narcolepsy.

 (2) There is massive underreporting in a government-operated passive reporting system of adverse reactions to vaccines. The Federal Department of Health and Human Services (HHS) admits that there is systemic underreporting in VAERS, since it is a system of passive reporting, and information is not automatically collected, but can be voluntarily submitted by anyone. The commentator noted that reports vary in quality and completeness. The National Vaccine Information Center states that it is estimated that less than 10% of vaccine-related health problems are reported to VAERS.

 (3) HHS promotes the ''coincidence myth'' of sudden infant death syndrome and other adverse health effects of vaccines. The commentator quoted an HHS statement that 10 million vaccines a year are given to children between 2 and 6 months of age, and at this age infants are at greatest risk for certain medical adverse events, including high fevers, seizures and sudden infant death syndrome. The commentator highlighted a statement by HHS that some infants experience these events shortly after a vaccination by coincidence.

 (4) Vaccines contain numerous toxic ingredients. The commentator provided several links to government and industry documents to support this statement. The commentator stated that a highly toxic mercury preservative remains in flu vaccines, including nonmercury flu shots, and provided several links in support of this information. The commentator stated that the government admitted that even in single dose flu vaccines thimerosal is present in trace amounts. The commentator stated that mercury has been replaced by aluminum, which some consider even more toxic than mercury.

 (5) Vaccines spread disease. The commentator stated that the vaccinated population actually threatens the unvaccinated population by spreading or shedding disease. The commentator stated that herd immunity is a shocking reversal of the truth by the vaccine industry to confuse the issue, deny responsibility for spreading diseases and target those who refuse to be vaccinated.

 (6) There is no effective Federal oversight of vaccine studies, of vaccines' safety or effectiveness, or the actual number of people who have been harmed. The commentator stated that the Federal government created a passive reporting system, VAERS, which relies upon reports from the industry, medical professionals and victims, but does not check the accuracy of the reporting system.

 (7) There is no effective Federal oversight of manufacturers' facilities, including foreign manufacturers in China and India who produce the most vaccines and medicines. The commentator stated that these manufacturers are not being inspected by the main United States regulatory agency charged with protecting the health of the American consumer.

 (8) Government institutions are protecting the ''vaccine industry from liability and lawsuits and are not protecting the public's health.'' The commentator asked why, if vaccines are stated to be ''extraordinarily safe'' by a major vaccine proponent physician why are they shielded by Congress and the United States Supreme Court from pharmaceutical corporation product liability and physician malpractice lawsuits when vaccinations cause the death or injury of an individual. The commentator stated that the vaccine industry was going out of business due to law suits from vaccination victims until Congress came to its rescue in 1986, by passing the National Childhood Vaccine Injury Act of 1986 (42 U.S.C.A. §§ 300aa-1—300aa-34), which created the National Vaccine Injury Compensation Program and the Vaccine Court. The commentator stated that the Vaccine Court places the burden on victims to prove harm, rather than on vaccine manufacturers to prove safety. According to the commentator, despite these onerous burdens $3.3 billion has been awarded to victims since then. The commentator stated that the National Childhood Vaccine Injury Act of 1986 allows vaccine injury victims to sue manufacturers when they did not receive compensation. Since 2011, the Supreme Court has shut off all access to the courts.

 (9) The history of the vaccine fraud is the all-to-familiar history of collusion between government and business.

 (10) Vaccinations are a violation of the ''precautionary principle'' and the Hippocratic Oath, ''first do no harm.'' The commentator stated that the medical profession's reputation is in shambles because preventable medical errors are the third leading cause of death in the United States and claim the lives of approximately 400,000 patients each year. The commentator stated that the medical profession's general support for vaccination will worsen these statistics and justifiably destroy the public's trust.

 The Department disagrees with these commentators, and has not changed the final-form rulemaking regarding this topic. The Department has the authority, through the delegation of the General Assembly and the application of its police powers, to require certain immunizations for school entry and attendance, and the Department and the Department of Education have the authority through the application of their police powers to exclude a child who fails to comply with that requirement. The Fourth Amendment to the United States Constitution protects individuals from unreasonable searches and seizures by the government. The commentator raising the Fourth Amendment to the United States Constitution neither explained how a requirement that children be vaccinated prior to school attendance or entry is an unreasonable search or seizure, nor has the commentator cited any case law to that effect. In fact, the Department's ability to require vaccinations upon school entry and attendance is in Commonwealth law and has been upheld by the Pennsylvania Supreme Court, which stated that it is within the police powers of the Commonwealth to exclude from school children who have not been appropriately vaccinated. Stull.

 In Stull, the plaintiff received notice from the school that his daughter, beginning December 11, 1905, would be excluded from school in violation of the act of June 18, 1895 (P.L. 203, No. 124), which requires students be vaccinated prior to admission into school. In deciding the case, the Pennsylvania Supreme Court pointed out that the question in the case, whether the act that requires vaccination as a condition precedent is a valid exercise of the police powers of the Commonwealth, had been decided twice—once in Duffield v. School District of Williamsport, 162 Pa. 476 (1894) and again in Field v. Robinson, 198 Pa. 638 (1901). In Stull, the court stated that ''vaccination is a highly useful ameliorative if not always a preventive of one of the greatest scourges that have in past times afflicted humanity, and that the regulation of it by statute is not only a justifiable but a wise and beneficent exertion of the police power over the public health.'' See also Nissley v. Hummelstown Borough School Directors (Nissley), 18 Pa.C.C. 481 (1896). The case law is old, but remains good law.

 Although the Department, with the approval of the Board, has the authority to create the list of immunizations for school attendance, it is still the case that a parent who chooses to refuse vaccinations for his child because of a religious belief or a strongly held moral belief that rises to the level of a religious belief, or because a child has a medical contraindication to a vaccine, may seek an exemption from these requirements. With an exemption, the child may still attend school.

 The Department does question several statements made by these commentators. For example, the statement by a commentator that vaccines are not effective and they are full of toxic mercury because several friends developed influenza after having been vaccinated against influenza. While the Department notes that it is not adding flu vaccine to the list of recommended immunizations, the Department believes some discussion of the flu vaccine is warranted. The Department is aware that not all vaccinations are 100% effective; in fact, the yearly flu vaccine may or may not be effective dependent on which strain of flu is actually present in this Commonwealth. Flu vaccine is developed several months before flu season in the United States, and it contains antigens against strains that are being seen in other countries, whose flu season occurs before that of the United States. The flu vaccine usually includes antigens against three strains, and some years the vaccine is a better match for the actual strain than others. In all cases, getting the flu vaccine tempers the severity of the flu if the individual happens to get it in spite of being vaccinated. In no case can the flu vaccine cause the flu. It is a killed vaccine, and cannot give any person the flu. A person may have a reaction to the flu vaccine that includes achiness and a low-grade fever for a short period of time. This, again, is minimal compared to the 2-week to 4-week time frame of the actual flu, complete with fever, pains, malaise and cough. Further, many persons believe they have had the flu, but have not. There are viruses that include the same types of symptoms. It is impossible to tell whether one actually has the flu without having a test done.

 With respect to the statement that the Department, the Department of Education and schools are acting unconstitutionally and bullying, coercing and administering vaccines without true informed consent, the Department reiterates that its actions with respect to setting a list of diseases against which children shall be immunized is a legal delegation of legislative authority to it through the Public School Code of 1949, and falls within the accepted police powers of the Commonwealth. See Stull. The Department notes that it does promote vaccination and require childhood immunizations for school entry and attendance because it strongly believes based on its research and its experts that vaccines are important, safe and effective in preventing childhood disease.

 The Department notes that while consent may be required for a child to be vaccinated, ''informed consent'' is not. The term ''informed consent'' is specific in Commonwealth law. In fact, although a parent or guardian (or a minor in some cases) is requested to give consent to a vaccination, a vaccination does not, by law, fall upon the list of medical procedures that requires ''informed consent.'' See section 504(a) of the Medical Care Availability and Reduction of Error (MCARE) Act (40 P.S. § 1303.504(a)). The Department, when it does provide vaccinations, provides a Vaccine Information Statement to a child receiving a vaccine from the Department, which contains side effects and risks of vaccines, and does seek written consent from the child's parent or guardian.

 The Department reiterates that a parent or guardian has the power to withhold consent for a child to be vaccinated. If the parent or guardian refuses, the heath care provider does not vaccinate the child against the will of the parent or guardian. The Department has no authority to change that requirement, and would not forcibly vaccinate a child without consent. The Department is, under law and its police power, requiring a child to have certain immunizations to attend school. A parent or guardian who has a firmly held conviction in the nature of a religious belief, or who obtains a medical exemption, can have the child admitted to school even if he does not consent to a vaccination.

 With respect to concerns regarding schools obtaining medical information, that information is required to be provided to schools by law and becomes part of the student's education record. The requirements for education record information in schools are covered by section 444 of the Family Educational Rights and Privacy Act of 1974 (FERPA) (20 U.S.C.A. § 1232g), which protects a student's privacy. A student's immunization records are not considered to be a student education record within the purview of FERPA. See http://www.astho.org/programs/preparedness/public-health-emergency-law/public-health-and-schools-toolkit/comparison-of-ferpa-and-hipaa-privacy-rule/.

 In any case, what school districts report to the Department regarding vaccines is in the aggregate, and does not include any child's identifying information. The Department does note that if an outbreak of diseases were to occur in a school that requires the Department's public health intervention, the Department would be able to obtain information regarding the outbreak, including identifying information regarding children. Once the Department had that information, the information could only be released by the Department to prevent and control the spread of disease. See Chapter 27, Subchapter C and sections 3 and 15 of the Disease Prevention and Control Law of 1955.

 With respect to comments regarding manufacturer's labels, manufacturers of products warn users of products of possible problems with products in part out of concern for liability. The studies of the safety for MCV and pertussis were sufficient for ACIP to determine that the vaccine's benefits outweigh its risks. The Department has accepted, and the Board has approved, these recommendations.

 The Department previously addressed comments regarding vaccine safety and the risks versus the benefits of pertussis and MCV vaccines in this preamble.

General comments in opposition to vaccination and vaccine additives

 One commentator provided a letter he sent to United States Senator Pat Toomey stating that vaccines never healed anyone and have done massive damage to the people throughout history. The commentator stated that mercury, aluminum, formaldehyde, antifreeze, live virus from degraded (rotted) monkey kidney tissue, cancer-causing S40 in blood, or cow or dog blood and aborted baby's human cells are found in vaccines. The commentator stated that vaccines contain monosodium glutamate (MSG), and that this toxin blocked leptin, which signals to the brain that the body is full. The commentator stated that this was a major causative in the obesity in the United States. The commentator asked why this was in vaccines, and what good it did. The commentator asked whether there was any sanity to this scenario, and whether the Department really believed in the safety of vaccines. The commentator stated that the Department was reviewing only one side of the story, ''reports coming from the CDC and so called peer reviews from reliable, hmm, sources.'' The commentator stated that the peer review issue was a scam, and that facts and numbers do not lie. The commentator provided a number of links to various articles that prove the truth about vaccinations and about herd immunity, and stated that herd immunity is a lie.

 The commentator stated that he has hundreds of links that show who the CDC and the World Health Organization really are, how they have been caught lying and defrauding people for many years and how they have caused damage to people worldwide throughout the ages. The commentator stated that the measles pandemic is nothing more than a lie on the part of vaccine manufacturers fueled by propaganda of the ''MSM.'' The commentator stated that there were 176 cases of measles in the United States related to the Disneyland outbreak and that there are about 650 cases of measles Nationwide every year. No deaths and a lifetime of immunity for the unvaccinated. It is common knowledge that there are vaccine-related deaths and permanent disabilities from vaccines by the thousands. The commentator noted that there is no liability for vaccine manufacturers and no repercussions. Drug manufacturers are permitted to continue maiming and killing over 100,000 people every year. The commentator asked how this is saving lives. The commentator asked if United States Senator Pat Toomey would be willing to have his children and grandchildren vaccinated fully, with the 300 vaccines that are awaiting the mandate. The commentator stated that this was not in line with the United States Constitution, particularly the Fourteenth Amendment. The commentator stated that one child or one adult compromised or killed by vaccines is one too many. The commentator stated that those who do not learn from their mistakes are bound to repeat them.

 One commentator stated that much of the commentator's concern rested with the presence of life-destroying aluminum salts, preservatives and fetal human cells in vaccines. The commentator stated that the safety of aluminum in humans rests on a study in which healthy adults were given a miniscule amount of aluminum intravenously. According to the commentator, most medical professionals can testify that intravenous intake is vastly different in kind from intramuscular injection. The commentator stated that it is this single study on which the claim that aluminum or aluminum salts in vaccines is safe rests. The commentator cites an article which confirms that there is no safe alternative antigen prepared for market. Jefferson, T., Rudin, M. and Di Pietrantonj, C. (2004), ''Adverse Events after Immunisation with Aluminium-Containing DTP Vaccines: Systematic Review of the Evidence,'' The Lancet Infectious Diseases, 4(2), 84—90. The commentator quoted the article as stating ''[d]espite a lack of good quality evidence, we do not recommend that any further research on this topic is undertaken.'' According to the commentator, this means that because there is no safe alternative, the problem will not be looked at too closely. The commentator cited other studies examining aluminum intramuscular injection into children and rabbits, and stated that these studies confirmed that aluminum did not exit the body but went directly to organs and to bone mass. The commentator provided a list of peer reviewed articles on the damage of aluminum and aluminum hydroxide. The commentator stated that they are waiting for an effective and safe vaccine, and until then should not be required to inject a verifiably corrosive and neurological damaging antigen. The commentator claimed the ongoing and untouchable freedom of religious conscience, along with the freedom of parents to assume the financial and time burden of homeschooling without medical interference from the government.

 One commentator stated that she is a mother of four children and has done research into the issue of immunizations. She stated that she vaccinated her first two children because that is what she was led to believe. She stated that she then started educating herself and that there was so much change with the amount of vaccines given when smallpox was an issue, and even then there was an increase in the disease. The commentator stated that there is no herd immunity and that no resurgent epidemics have occurred. The commentator stated that vaccine effectiveness cannot be determined unless one is exposed to the disease following vaccination, but she has not found research. The commentator stated that vaccines contain toxic poisons linked to neurological damage, including aluminum, thimerosal, antibiotics, MSG, formaldehyde, lead, cadmium, glycerine, acetone and yeast proteins. She commented that one cannot even sue a manufacturer if there is harm because Congress has eliminated the ability to directly sue providers or manufacturers responsible for vaccine injuries. Knowing all this, she asks why she would choose to vaccinate her child. The commentator stated that if people choose to vaccinate their children or themselves for protection against a harmful disease because that is what they believe, why should they concern themselves that others have not. The commentator states that they would then have to have faith that they are protected and the ones that are not vaccinated would get the disease. She asked why we are letting the government tell us what to do with our children.

 Several commentators mentioned that vaccines are derived from fetal tissue. One commentator stated that vaccines are derived from murdered babies, through abortions. The commentator stated that it is a common myth that the cell lines being used to develop vaccines were taken from an abortion in the 1960s and that they self-replicate, making it possible to produce more vaccines without procuring more abortions. According to the commentator, this could not be farther from the truth, and a new cell line called WALVAX2 has been developed from new abortions recently.

 The Department is not in a position to dissuade these commentators from their beliefs. The Department has given its reasons for relying on herd immunity. The Department and those who choose to vaccinate most likely do not do so through a belief or faith that they will be protected by the vaccination, but rather through an informed choice, just as one commentator stated that she made in choosing not to vaccinate her children. Religious/philosophical and medical exemptions remain available for those who are eligible for them.

 With respect to concerns raised about vaccine ingredients, particularly about the statement that vaccines cause healthy children to become unhealthy and their immune systems are becoming compromised, children are exposed to many foreign antigens every day. Adverse Events Associated with Childhood Vaccines, p. 63. Eating food introduces new bacteria into the body, and numerous bacteria live in the mouth and nose, exposing the immune system to still more antigens. An upper respiratory viral infection exposes a child to from 4 to 10 antigens, and a case of strep throat exposes a child to from 25 to 50 antigens. According to Adverse Events Associated with Childhood Vaccines. According to Adverse Events Associated with Childhood Vaccines, ''[i]n the face of these normal events, it seems unlikely that the number of separate antigens contained in childhood vaccines. . .would represent an appreciable added burden on the immune system that would be immunosuppressive.'' Available scientific data show that simultaneous vaccination with multiple vaccines has no adverse effect on the normal childhood immune system.

 Millions of doses of vaccines are administered to children in this country each year. Ensuring that those vaccines are potent, sterile and safe requires the addition of minute amounts of chemical additives. Chemicals are added to vaccines to inactivate a virus or bacteria and stabilize the vaccine, helping to preserve the vaccine and prevent it from losing its potency over time. The amount of chemical additives found in vaccines is very small. The Department does not believe this concern invalidates this final-form rulemaking. The possibility that the small amount of additives may cause a serious allergic response is outweighed by the efficacy of the vaccine in preventing serious disease and disease outbreaks. Formaldehyde is used to inactivate toxic proprieties in vaccines that contain toxins (for example, tetanus). It is also used to kill unwanted viruses and bacteria that might be found in cultures used to produce vaccines. Aluminum gels or salts of aluminum are added as adjuvants to help the vaccine stimulate production of antibodies to fight off diseases and aid other substances in their action. In vaccines, adjuvants may be added to help promote an earlier response, more potent response or more persistent immune response to disease. Some, like gelatin and MSG, are added to prevent deterioration and to stop the vaccine sticking to the side of the vial. Some, like antibiotics, yeast protein and egg protein, are remains of the vaccine production process. ''Clear Answers and Smart Advice,'' p. 5. None have proven harmful in animals or humans. ''Clear Answers and Smart Advice,'' citing Offit, MD, P. A. and Hackett, PhD, C. J. (2003), ''Addressing Parents' Concerns: Do Vaccines Cause Allergic or Autoimmune Diseases,'' Pediatrics, 111(3), 653—659, retrieved from http://pediatrics.aappublications.org/content/111/3/653.

 Specific attention was drawn by commentators to aluminum. If a baby follows the standard immunization schedule, he is exposed to about 4 to 6 milligrams of aluminum at 6 months of age. By comparison, a baby is exposed to 10 milligrams if he is breastfed, 40 milligrams if he is fed cow's milk-based formula or 120 milligrams if he is fed soy formula. There are about 200 milligrams of aluminum in a standard antacid tablet. ''Clear Answers and Smart Advice,'' p. 6, citing Children's Hospital of Philadelphia, Vaccine Education Center, www.vaccine.chop.edu/service/vaccine-education-center/hot-topics/aluminum.html (accessed July 30, 2016).

 Specific concern is also raised relating to thimerosal, which contains ethyl mercury. This differs from methyl mercury, which is the type of mercury that has given concerns in connection to the consumption of fish. These two forms of mercury are processed differently in the human body. While methyl mercury is known to cause psychiatric problems, including mad hatters disease, ethyl mercury is rapidly eliminated from the body within 1 week. The inclusion of mercury in vaccines is a frequent concern raised by persons who are of the opinion that vaccines are more dangerous to health than the disease itself. While most vaccines became thimerosal free after 2001, some, like flu vaccines, still include it. ''Clear Answers and Smart Advice,'' p. 4. Most importantly, influenza vaccine is not on the Department's list of required immunizations. The only vaccine on the Department's list that still retains a small amount of thimerosal is one of the MCV vaccines, although there are thimerosal alternatives. The Department notes that if a person receives single antigen doses of vaccines against tetanus, rather than Tdap or DTaP, there would be small amounts of thimerosal in the vaccine. Levels of thimerosal in vaccines may be found at www.vaccinesafety.edu.

 In addition, commentators raised issues regarding fetal tissue, and specifically stated, in some instances, that babies were being killed to make vaccines. The Department has not revised this final-form rulemaking in response to these comments. Fetal tissue is not currently used to produce vaccines. Cell lines generated from a single fetal tissue source are used to produce vaccines. Some vaccines, including varicella vaccine, are made from human cell line cultures. Vaccine manufacturers obtain human cell lines from FDA-certified cell banks. Commentators stated that existing cell lines are dying out, and that studies show that new fetal tissue lines are being used, citing a Chinese researcher as developing these lines. The Department is unaware that any existing vaccine includes any new cell line, or that it is likely to do so. In any event, these commentators, and persons with religious objections to the use of cell lines in vaccines, may make use of the religious and philosophical exemption to refuse a vaccination and continue to attend school.

 Several commentators also raised issues regarding formaldehyde use in vaccines. Formaldehyde has a long history of safe use in the manufacture of certain viral and bacterial vaccines. It is used to inactivate viruses so that they do not cause disease (for example, polio virus used to make polio vaccine) and to detoxify bacterial toxins, such as the toxin used to make diphtheria vaccine. Formaldehyde is diluted during the vaccine manufacturing process, but residual quantities of formaldehyde may be found in some current vaccines. The amount of formaldehyde present in some vaccines is so small compared to the concentration that occurs naturally in the body that it does not pose a safety concern.

 Formaldehyde is also produced naturally in the human body as a part of normal functions of the body to produce energy and build the basic materials needed for important life processes. This includes making amino acids, which are the building blocks of proteins that the body needs.

 Formaldehyde is also found in the environment and is present in different ways. It is used in building materials, as a preservative in labs and to produce many household products.

 The body continuously processes formaldehyde, both from what it makes on its own and from what it has been exposed to in the environment. When the body breaks down formaldehyde, it does not distinguish between formaldehyde from vaccines and that which is naturally produced or environmental. The amount of formaldehyde in a person's body depends on their weight; babies have lower amounts than adults. Studies have shown that for a newborn of average weight of 6 to 8 pounds the amount of formaldehyde in their body is 50 to 70 times higher than the upper amount that they could receive from a single dose of a vaccine or from vaccines administered over time.

 Excessive exposure to formaldehyde may cause cancer, but the latest research has shown that the highest risk is from the air when formaldehyde is inhaled from breathing, and occurs more frequently in people who routinely use formaldehyde in their jobs. There is no evidence linking cancer to infrequent exposure to tiny amounts of formaldehyde through injection as occurs with vaccines. See FDA (2014), ''Common Ingredients in U.S. Licensed Vaccines,'' retrieved from http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm187810.htm.

 One commentator pointed out that the HHS' National Vaccine Injury Compensation Program has a Vaccine Injury Table that supplies a run-down of health conditions and associated vaccines. The commentator noted that there is quite a list of health consequences that result from getting vaccines. The commentator also noted the list of warnings on the package inserts placed there by pharmaceutical companies. The commentator pleaded with the Department, for the sake of children and future generations, not to make the amendments in the proposed rulemaking.

 The commentator stated that her grandchildren have an exemption based on medical, philosophical and religious reasons, out of a legitimate concern for her grandchildren's safety.

 The Department is not in a position to dissuade the commentator from her beliefs. The Department notes that the exemptions exist in the law for those who have a strong moral and ethical aversion to vaccination. The Department agrees that there are potential health consequences listed with respect to vaccines in the Vaccine Injury Table issued by HHS' National Vaccine Injury Compensation Program. With respect to manufacturer's labels, manufacturers of products warn users of products of possible problems with products in part out of concern for liability. Because a manufacturer cannot prove that a vaccine is effective for a lifetime, it cannot say so without the possibility of legal difficulties. Safety studies have been done of both MCV and pertussis, which are included in this final-form rulemaking, and the Department has chosen to follow ACIP recommendations in including these vaccines.

Comments regarding combination vaccines

 IRRC noted that many commentators opposed the idea of doses of vaccines being administered in a combined form and asked the Department to state this clearly in this preamble and in the RAF to clearly explain the need for the amendment.

 Multiple commentators, including PACIC, opposed the Department's requiring combination vaccinations and recommended that the Department list each antigen separately. According to some commentators this would simplify the amendment process should combinations change in the future. This would also ensure accuracy in data collection and publication. Commentators noted that some vaccines were still available separately, and listing each antigen separately is best, and should not be changed. Further, the commentators stated that evidence of immunity was different for some of the vaccines, and that the regulation was unclear. Commentators recommended that each disease individually list what could be given as evidence of immunity. One commentator stated that the Department should list antigens and number of doses separately and that this would make the regulations easier to understand. Since vaccines are regularly changing, and some children get vaccinations in other countries where other options are available, this would be easier. The commentator recommended a chart which explains what can be used as evidence would also be easier.

 One commentator stated that she disagreed with the Department's proposed amendment to delete separate listings for measles, mumps, rubella, tetanus, diphtheria and pertussis vaccines that are currently most commonly consumed as combination shots. The commentator stated that instead of listing them separately, they will only be listed in their combination forms. The commentator stated that she was against this, and her information comes from the FDA's vaccine insert web page. The commentator stated that she did not believe in mixing vaccines and giving them in combination. The commentator stated that changing the listings by eliminating single vaccinations that are still available is not fair and not necessary and only encourages vaccine manufacturers to eliminate individual vaccines.

 One commentator stated that he and his siblings had typical childhood diseases without complications or visits to the doctor. He stated that when he was a child, it was rare to know any child who had cancer, diabetes, allergies, asthma, ADHD or autism. He stated that these chronic conditions are much more prevalent since the vaccine schedule has tripled, and common and reasonable people have to ask why public health officials refuse to examine the connection between them and vaccines. He stated that this is especially troubling when thousands of parents link the decline in their children's health to vaccinations. He stated that administering multiple doses of combination vaccines overloads the fragile systems of babies and young children.

 One commentator stated that it is common for vaccines to be given in combination and not spaced out as previously practiced. The commentator stated that the safety and efficacy of these vaccines have not been studied and it is quite possible that a lifetime of immunity is not being established, which is the intended result of vaccination. The commentator stated that vaccines have to be changed periodically for the goal of herd immunity to take place over a period of several decades. The commentator stated that since most vaccines are made by one manufacturer, essentially there is a monopoly when fair competition does not exist, and possibly a superior vaccine is not being delivered to the public.

 The commentator specifically referenced the MMR vaccine, stating that people are starting to be educated on the dangers of mixing vaccines in one dose. The commentator stated that the MMR vaccine is currently under scrutiny by reputable medical professionals and hopefully will one day be removed from the schedule completely. The commentator asked that the Department help her to educate persons on what is actually in the vaccine and the dangers listed on the vaccine insert sheet from Merck. The commentator stated that the vaccine has three different live viruses in one injection. The commentator stated that there are live measles virus cultured in a chicken embryo cell culture, which is chicken DNA, live mumps virus, cultured in chicken embryo cells, which is chicken DNA, and live rubella virus cultured in human DNA, which is aborted fetal lung cells. The commentator stated, as if that is not repulsive enough, these cultures are then mixed with growth medium of fetal bovine serum, which is fetal cow blood. The commentator stated that the cow blood is screened, but that does not guarantee that a person will not be infected by Creutzfeldt-Jakob disease. The commentator noted that there would be no liability for the manufacturer. The commentator stated that the Merck insert clearly states that the MMR vaccine has not been evaluated for carcinogenic or mutagenic potential. The commentator stated that no studies have been done but let's keep injecting babies and do it again as young children. The commentator stated that it makes absolutely no sense to inject a perfectly healthy infant with these diseases all at once in a vaccine filled with toxins and do it again right before they start school. The commentator asked that the Department not remove individual vaccines from the list, and stated that she was counting on the Department to help keep children in this Commonwealth safe, and to keep the door opened for individual vaccines, not bundling vaccines.

 One commentator stated that it was misleading to list vaccinations in their combination forms, since parents are not aware that combination vaccinations are actually multiple vaccinations in one dosage. The commentator stated that they should be listed separately since it is still optional to receive combination vaccinations separately, and this will ensure accuracy in reporting.

 One commentator stated that referencing combination shots rather than individual antigens further reinforces the misinformed and dangerous concept that vaccines are one size fits all. Not all antigens are appropriate for all children. Many people strongly advocate for safer vaccines through single antigens. In many countries combination shots are not required due to safety concerns.

 Two commentators stated that the antigens for MMR and Tdap should be listed separately as they are separately available. The commentators stated that information should not be general, and should be as specific as possible.

 One commentator stated that with combination vaccinations, if a child has an allergic reaction, how will parents know to which of the antigens the child reacted. The commentator stated that it would probably be after the autopsy.

 The Department has not revised this final-form rulemaking regarding this topic. Even if the Department listed the diseases separately, there are no single antigen vaccines available in the United States for measles, mumps, rubella, diphtheria, tetanus or pertussis. The Department originally added language allowing for combination vaccinations in 2010, to take into account the fact that single antigen vaccinations were becoming scarce:

The Department supports the commentator's position that combination vaccines are preferable because of the reduction in cost by eliminating multiple visits, stocking and storing multiple vaccines and stress on the child. The Department's existing regulations neither encourage nor discourage the use of combination vaccines; it should be noted that many vaccines are not available in this Commonwealth or United States as single antigen vaccines. The Department believes that health care professionals, if they have single antigen vaccines available to them, will take these issues into consideration in deciding which vaccine to use. Given the concern expressed by commentators, however, the Department has decided to revise this subsection to add language acknowledging that a combination vaccine is an acceptable vaccine for purposes of school attendance, as well as a single antigen vaccine. The Department added this language even in situations when a combination vaccine currently does not exist to anticipate the continuing development of these vaccines. The Department agrees with the commentators and strongly encourages the use of combination vaccines when appropriate and available.

 40 Pa.B. 2747. See generally § 23.83(b). Since that time, certain single antigen vaccines have become unavailable. Tetanus toxoid vaccine production was discontinued in 2013. The CDC, when asked, was unaware of any diphtheria toxoid single-antigen vaccines historically being available or used in the United States.

 The Department is acknowledging that single antigen vaccines for measles, mumps, rubella, diphtheria, tetanus and pertussis are no longer available in the United States. The Department did not deleted the single antigen vaccinations for the MMR vaccine. The Department amends § 23.83 to specifically reference all three diseases at once, rather than separately, and to specifically allow for both a combination antigen vaccine in § 23.83(b)(3)(i) and single antigen vaccines in § 23.83(b)(3)(ii). The language allowing for the immunization to be given as a single dose vaccine and as a multiple dose vaccine was in the regulation prior to this final-form rulemaking and still exists.

 The Department currently takes into account the issue of what immunizations are available in other countries, and would provide advice to a school nurse in that regard were he to question whether or not an immunization could be accepted. The Department notes that for this reason the language regarding single antigens for MMR vaccination has not been amended, but the paragraphs have been combined into one paragraph to acknowledge that the individual antigen vaccines are no longer available in the United States.

 The Department also disagrees that what is required for evidence of immunity is unclear. In addition to proof of the immunization, immunity to measles and rubella may be shown by evidence of immunity proved by laboratory testing, immunity to mumps may be shown by a written history of mumps disease from a physician, CRNP or PA, and immunity to varicella may be shown by a history of disease either by a parent or guardian or physician, CRNP or PA. Immunity for any other listed disease requires a record of the immunization itself. This is specifically set out in the regulation. The Department believes that there is no need to create a chart for the four instances in which a history of disease or a laboratory test is acceptable as proof of immunity.

 The Department disagrees with the commentators regarding the safety and efficacy of combination vaccines. Studies have found that combination vaccines in fact benefit children, because fewer injections will be required to protect against disease, allowing for the introduction of new vaccines into the immunization schedule, and thereby preventing additional disease. ''Combination Vaccines for Childhood Immunization,'' (Combination Vaccinations), MMWR, 48(RR 5) (1999), 1—15, retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/rr4805a1.htm; Halsey, MD, N. A. (2001), ''Safety of Combination Vaccines: Perception Versus Reality,'' The Pediatric Infectious Disease Journal, 20(11), S40—S44. The Department notes that a study done by the University of Rochester with a grant from GlaxoSmithKline Biologicals, makers of Pediarix, a DTaP and inactivated poliovirus vaccination, published in The Journal of Pediatrics, also found that no efficacy or safety is compromised when clinicians administer a combination vaccine that streamlines the process. See https://www.urmc.rochester.edu/news/story/1673/combination-vaccine-okay-for-infants-rochester-study-shows.aspx. According to ACIP, the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP), ''[t]he use of combination vaccines is a practical way to overcome the constraints of multiple injections, especially for starting the immunization series for children behind schedule. The use of combination vaccines might improve timely vaccination coverage.'' ''Combination Vaccinations,'' p. 6. ACIP, AAP and AAFP stated that ''use of licensed combination vaccines is preferred over separate injection of their equivalent component vaccines. Only combinations approved the U.S. Food and Drug Administration (FDA) should be used.'' ''Combination Vaccinations,'' p. 6. The Department, with the approval of the Board, is following the recommendations of ACIP, AAP and AAFP, and allowing combination vaccines that are licensed by the FDA.

 With respect to one commentator's statements regarding the safety of the MMR vaccine, and her wish to see it eliminated, the Department's regulation regarding the requirement of an MMR for school attendance is in place, and is not impacted by this final-form rulemaking. The Department does note that no peer reviewed valid scientific study has yet shown the link between vaccines and autism. What had been the seminal study in this area, a 1998 research study, was severely criticized, discredited and later retracted by The Lancet, the British medical journal that published it. The Department discussed the issue of autism previously in this preamble.

 Further, the Department notes that between 1950 and 1963, when a licensed measles vaccine was introduced, there were 320,000 to 760,000 cases of measles yearly in the United States, the highest year being 1958 with 763,094 cases reported and 552 deaths. Measles is a highly contagious acute viral illness with a fever of equal to or greater than 101°F, rash, cough, coryza and conjunctivitis. It is airborne or droplet spread. Persons are communicable 4 days before the rash appears through 4 days after the rash appears. Measles can remain infectious for up to 2 hours after the infected person has left the room. Complications include otitis media, pneumonia, laryngotracheobronchitis (croup), diarrhea and encephalitis. It is more severe in the very young and may be associated with hemorrhagic rash, protein losing enteropathy, oral sores, dehydration, diarrhea, otitis media, blindness and severe skin infection.

 From the introduction of the measles vaccine in 1962 to 1989, when a spike in the number of measles cases occurred, the number of cases Nationwide dropped roughly from 1481,530 with 408 deaths in 1962 to 3,396 with 3 deaths in 1988. See Pink Book, Appendix E. A spike in measles cases occurred in 1989 to 1991, with the number of cases increasing to 27,786 in 1990. See Pink Book, Appendix E. This was attributable to low immunization rates. See Pink Book, p. 214 and 215. A second dose was recommended by the American Academy of Family Practitioners in 1989. In 1991, the number of cases fell to 9,643 Nationwide. Endemic measles was eliminated from the United States in 2000, although spikes in cases continue to be seen. No vaccine is either 100% effective or 100% safe. According to the Pink Book, the efficacy rates for these vaccinations are as follows: measles, 95%; mumps, 88% (range 66%—95%); and rubella, 95%.

 The Department notes that while some vaccines only have one manufacturer and, therefore, the quality of the vaccine may suffer because of the lack of competition, there are several vaccines that are manufactured by more than one company. Meningococcal conjugate vaccine, for example, is made by Sanofi Pasteur and Novartis. DTaP is manufactured by Sanofi Pasteur and GlaxoSmithKline. The Department does not mandate the brand name vaccine, but lists the disease against which the child shall be vaccinated. The Department notes that all vaccines that are added to the list of those required for school entry are first licensed by the FDA and then reviewed and approved by ACIP.

 With respect to the comment regarding fetal bovine serum, and concerns that this additive may expose children to Creutzfeldt-Jakob disease, commonly referred to as ''mad cow disease,'' the Department disagrees with the commentator. Fetal bovine serum is used in some vaccines as a growth medium. A ''mad cow disease'' scare regarding vaccines arose in the early 2000s following publications of newspaper articles regarding a ''mad cow disease'' outbreak in the United Kingdom and the potential that several drug manufacturers had used fetal bovine serum from countries at risk for ''mad cow disease.'' Vaccines: What You Should Know, p. 112 and 113. The FDA asked the Transmissible Spongiform Encephalopathy Advisory Committee and the Vaccines and Related Biological Products Advisory Committee to meet on July 27, 2000, to discuss this matter and the CDC then issued a public health service statement in the MMWR on December 22, 2000. The FDA found the threat of ''mad cow disease'' to be remote and theoretical, and no known case of transmission exists. FDA (2013), ''Vaccines and Variant CJD (vCJD) Questions and Answers'' (Vaccines and Variant CJD), retrieved from http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm143522.htm. However, to maintain public trust in immunizations, the FDA recommended the elimination of the use of bovine materials from countries at risk for ''mad cow disease.'' Vaccines: What You Should Know, p. 115; also cited by Children's Hospital of Philadelphia, ''Vaccines and Mad-Cow Disease'' (CHOP Vaccines), retrieved from http://www.chop.edu/centers-programs/vaccine-education-center/vaccines-and-other-conditions/vaccines-mad-cow-disease#.V6YC1k_2aUk. The FDA stated:

The FDA has looked at the benefit of vaccines and the risk of contamination of vaccines with the BSE agent. The Public Health Service, FDA, and FDA's advisory committees on Transmissible Spongiform Encephalopathy (TSEAC) and Vaccines and Related Biological Products (VRBPAC) believe the risk that anyone will get vCJD from a vaccine to be remote and theoretical. Vaccines have a proven benefit in reducing the incidence of serious, often life-threatening diseases. The absence of high levels of routine vaccination leads to an increased incidence of vaccine preventable diseases. Therefore, removal of licensed vaccines from the market for a remote, theoretical risk can have serious medical and public health consequences. In considering the balance of risks and benefits, the use of all vaccines, even those which were manufactured with bovine derived materials from unapproved sources, should continue.

 ''Vaccines and Variant CJD,'' p. 2. It should also be noted that in terms of the use of fetal bovine serum in the vaccine process, serum comes from blood, and blood from infected animals or blood from infected people has never been shown to be a source of infection to humans. Vaccines: What You Should Know, p. 115; see also ''CHOP Vaccines.'' The serum is diluted and eventually removed from cells during the growth of vaccine viruses. Prions are propagated in mammalian brains and not in cell culture used to make vaccines. Therefore, prions are unlikely to be propagated in the cells used to grow vaccine viruses. See ''CHOP Vaccines.'' The Department has not revised this final-form rulemaking regarding this topic.

 The Department addressed concerns regarding vaccine additives and the safety of multiple vaccines being given at one time elsewhere in this preamble.

Comments regarding vaccine safety

 Two commentators stated that they had recently become grandparents for the first time, and that the granddaughter received her 3-month vaccinations in accordance with CDC recommendations. The commentators stated that she had a very severe reaction, which included fever, diarrhea and an encephalitic cry, which each of the commentators recognized because each is a nurse in the health care industry. The commentators stated that with each cry she thrashed her arm backwards. The commentators stated that the behavior lasted 10 days before she returned to a more normal status. The commentators stated they would like to have her sensibilities tested before proceeding with the recommended scheduled vaccines to ensure she will not suffer more permanent damage. The commentators stated that they did not understand why the United States Supreme Court has labeled vaccines as unavoidably unsafe but that the Department is not taking safeguards. The commentators stated that it was absurd that great risks were being taken with the lives of so many young and fragile children.

 One commentator stated that she is a parent of a child whose health declined with every round of routine immunizations. The commentator stated that her child is now suspected of having a mitochondrial disorder that has been noted in medical literature and vaccine compensation court legal proceeding as being associated with childhood vaccination. The commentator stated that she did not understand how vaccines could be labeled as ''unavoidably unsafe'' and yet precautions are not being taken on a public health level to screen for those children and individuals who may be vulnerable or most harmed by vaccine injury and vaccine reactions in an attempt to prevent vaccine harm.

 One commentator stated that she is not opposed to the development and distribution of vaccinations to support the therapy involved in developing immunities. However, the commentator is opposed to basic freedoms being restricted by over-complicated legislation. The commentator stated that her own children were vaccinated, but shortly after vaccinating each one they were hospitalized with complications that she did not recognize as being related to the vaccines. The commentator stated that she chose to vaccinate because she was told that it had to be done, and if the children were not vaccinated, the children would likely contract the diseases which the vaccines were supposed to prevent. The commentator stated that one daughter ended up with whooping cough after she went to the doctor's office for an unrelated vaccine, and the commentator had to care for her day and night for nearly a month. The commentator stated that another daughter was hospitalized as an infant and had to suffer through a spinal tap before the commentator realized that the child's condition was due to the vaccine she had been given 2 weeks before. The commentator stated that she has since spent a great deal of time learning about vaccinations, immunization and the risk associated with undergoing the schedule of vaccines dictated by the Department. The commentator uses the word ''dictated,'' because she sees her freedom to choose how the health and well-being of children are being managed being taken away.

 One commentator stated that she had studied vaccinations as a lay person for several years, and has concluded that she is not comfortable with their safety. She declined Tdap and MCV for 7th grade for her children for this reason. She raised the following issues in general:

 • Litigation against HPV manufacturers began in June 2016 in Japan; the Japanese government removed HPV from the recommended vaccine list.

 • A CDC whistleblower, granted whistleblower status by the Obama administration and requested to be subpoenaed by Congress, has yet to be acknowledged; his story was made public in 2014, and he submits that he and his colleagues at the CDC destroyed documents that supported a link between the MMR vaccine and autism in certain cohorts.

 • A letter of complaint by Sin Hang Lee, MC, FRCP, FCAP, Director, Milford Molecular Diagnostics Laboratory, Milford, CT, was written to the Director General of the World Health Organization against the Global Advisory Committee on Vaccine Safety, the CDC and others for misrepresentation of facts regarding safety of the HPV vaccine.

 • The American College of Pediatrics issued a statement in January 2016 regarding new concerns about the HPV vaccine.

 • Pharmaceutical representatives are coming out of the woodwork with stories about horrible corruption within the pharmaceutical industry.

 Because of this she stated that she believes there is a high likelihood of corruption surrounding how recommendations for vaccinations are made. The commentator stated that because of this her choice is to be conservative and hold off on further vaccines for her own children.

 One commentator stated that although everyone wants to protect immunocompromised children, all children need to be protected from the excessive number of vaccinations they are being given. The commentator stated that we need to work together and demand accountability from vaccine manufacturers, and require cleaner, safer vaccines before they are mandated on healthy children. The commentator stated that we need to demand that the CDC does its job and require longer testing on vaccines before clearing them for use and mandating them on children. The commentator stated that parents who have exemptions are sometimes the children of vaccine injured children that want to protect their other children. The commentator asked who were we to stand to protect immunocompromised children and not stand to protect children that have already been injured by vaccinations. The commentator stated that there are millions of these children and they are not being supported. The commentator stated that vaccine manufacturers have absolutely no liability so they have no incentive to make safer vaccines. The commentator stated that when a lawsuit is filed and won by these families, which is rare, taxpayers are paying for it instead of the vaccine companies. The commentator stated that pharmaceutical companies have all the money and their lobbyists and representatives are out there making sure the laws and regulations are in place for them to keep selling the government unsafe vaccines.

 Several commentators stated that the government and the medical and pharmaceutical industries should first do no harm. One commentator expressed concern that children were being harmed, families were being devastated and futures were being destroyed. The commentator stated that a parent has the right to make a truly informed choice about what is injected into a child's body which has the risk of permanent injury and death. The commentator stated that the government has a moral and ethical imperative to provide that right. One commentator stated that she had been a registered nurse for 16 years and had worked in a hospital all that time. She stated that as a citizen of the United States and as a resident of this Commonwealth, she must defend the United States Constitution and the Pennsylvania Constitution and she expected the Department to do the same. The commentator stated that she had taken an oath to be an advocate for the truth regarding the persons she cares for, and if medical personnel compromise, and do not defend these oaths, there is no limit to the evil and atrocities that will be committed in the name of medicine. She stated that together Federal, state and local governments should be held accountable to defend Constitutional rights to maintain truth and integrity in the process and conveyance of all medical and scientific information (all benefits, risks and alternatives) to obtain an individual's true consent. She stated that this true consent includes defending a citizen's or a resident's right to refuse based on the integrity of these truths.

 The Department has not revised this final-form rulemaking regarding this topic. The Department is not creating a new immunization program. The only new immunization requirements the Department is adding are a dose of MCV for entry into the 12th grade, or, in an ungraded class, for entry into the school year where the child turns 18 years of age, and a pertussis component, since certain vaccines, like single antigen diphtheria, single antigen tetanus and single antigen pertussis vaccine, are not available in the United States. The Department addressed the safety of those vaccines in the specific sections relating to those requirements. The Department is not adding HPV to the list of required immunizations for school entry and attendance. Further, the Department notes that exemptions still exist in law to allow concerned parents to exempt children from vaccinations under certain circumstances. Any claim of a link between MMR and autism has been sufficiently debunked by the retraction in 2010 by The Lancet, the British medical journal, of what was until then the seminal study in England. Further, safety of combination vaccines, multiple vaccines at one time, the number of required vaccines and additives to vaccines and other safety issues have been discussed elsewhere in this preamble.

 In addition, the Department notes that the right to request a medical, religious, or strong moral or ethical conviction exemption still exists in the law and in the regulations. The Department addresses the issue of informed consent previously in this preamble.

 PACIC asked that the Department provide the average number of children in this Commonwealth who are ''medically unable to obtain a vaccination.'' PACIC stated that the CDC is seeking to severely limit the conditions for which children may be eligible for a medical exemption. PACIC stated that requiring someone else to undergo a medical procedure that carries inherent risks for the sake of another individual is a novel concept in the United States where individual rights have always been honored. PACIC stated that upending this foundational principle should not be taken cavalierly.

 With respect to the commentator's question regarding the Department's reference to children who are medically unable to receive the vaccination, these are children with medical contraindications, for example, children with a contraindication to pertussis. A child with a medical exemption is medically unable to receive a vaccination. Although the Department has provided the number of children in school years 2014-2015 and 2015-2016 who had medical exemptions at the time data was collected, the Department also notes that a child's situation may change, and that a doctor may determine that a child cannot receive a vaccine at one point, but may be able to receive it at a later date. The Department has no way of knowing whether these children are in a provisional status at the present time, or have medical exemptions.

 Further, the CDC has no authority to limit what condition may warrant a medical exemption, nor does the Department. The decision that a particular condition warrants a medical exemption is determined by the child's doctor. ACIP lists contraindications to certain vaccines, but the decision regarding whether to a child should receive a medical exemption is within the scope of practice of the physician or a designee. The regulations do not affect that relationship. Further, the Department notes that, while it strongly encourages persons to think about whether their actions regarding vaccination impact other persons, it has not impinged on personal liberty by promulgating this final-form rulemaking. Acting under the statutory authority, the Department has added to the list of diseases and conditions for which an immunization is required to enter and attend school. The Department has not, and cannot, change the General Assembly's directive that children be able to obtain medical and religious exemptions to these requirements. A child who possesses an exemption is not impacted by this final-form rulemaking. That child may, in the case of an outbreak of a vaccine-preventable disease in a school, be excluded from school under the Department's authority to prevent and control disease in schools. See section 3(a) of the Disease Prevention and Control Law of 1955. In the event that the child contracts the disease, the child may be isolated or quarantined under that same authority. See section 11 of the Disease Prevention and Control Law of 1955. The Department notes that these exclusionary principles have long been upheld in the Commonwealth. Stull and Nissley.

Comments regarding pharmaceutical companies and vaccines

 One commentator stated that the pharmaceutical industry was stirring up hysteria to continue this revenue stream, whether it is necessary, beneficial or not. The commentator stated that there are too many uncertainties about the safety and effectiveness of so many vaccines just to bulldoze ahead because of media hype. The commentator stated that the inclusion of heavy metals like mercury in some of these vaccines is horrible. The commentator asked how pumping mercury into her grandchildren could improve their health.

 One commentator said that it should be up to the parents to decide if a child should get more immunizations, but if a pediatrician recommends it, most persons will comply.

 The Department hopes that physicians and parents discuss the medical issues, including immunizations, relating to their children and make decisions that are in the best medical interests of children. The medical exemption is in place for those who need it.

 One commentator stated that she was vehemently opposed to mandatory vaccinations, and that she and her sister had nearly died from the pertussis vaccination. The commentator stated that she believed strongly in scientific-based evidence that childhood illnesses build the immune system. The commentator stated that the proposed rulemaking was a violation of personal rights in many ways. The commentator stated that in these times of ''sinister profits'' being made by the ''likes of Dick Cheney'' and others, who buy up patents on vaccinations prior to ramping up general hysteria about Zika virus, flus and other diseases, it is imperative that the government is not allowed to control protecting immune systems from the hubris of scientists and their financial partners.

 One commentator stated that the number of vaccines on the childhood vaccination schedule have tripled since the 1980s and doubled since 2000. The commentator noted that the pharmaceutical industry has become a multibillion dollar industry attracting individuals looking to make money from all ends. The commentator stated that we must be mindful of an industry paying large sums of money to control the conversation regarding the health and safety of children. Another commentator hoped that, as a voting citizen in this Commonwealth, that the Department would choose to represent the commentator's views rather than those of ''big pharma.''

 One commentator stated that the only benefit of vaccines is the great financial gains of the pharmaceutical companies and the government that makes laws based on the companies' lobbyists. According to the commentator, vaccines cannot produce health or protection from disease. The commentator stated that they are loaded with nothing but toxic chemicals and DNA and RNA fragments from the tissues on which the bacteria and viruses are grown. The commentator stated that they have historically been and are now contaminated with retroviruses. The commentator stated that the health risks of vaccines are great, and are listed in the package inserts of the vaccines. The commentator stated that a vaccine is a pharmaceutical drug, and that healthy people do not need drugs to maintain their health. The commentator stated that the right to refuse vaccinations and any other medical treatment is a basic human freedom. The Hippocratic Oath states first do no harm but the Department is doing harm.

 One commentator said she would thank the Department for doing what was right and not giving in to pharmaceutical company bullying.

 The Department disagrees with any inference that its decisions to add to the list of immunizations required for entry and attendance at school is controlled by the pharmaceutical companies. The Department bases its decisions on recommendations from ACIP, and only adds those immunizations to the list that it believes are appropriate for children in this Commonwealth. The Department added varicella immunity to the list shortly after that vaccine became licensed for use. The Department then added Tdap and MCV for entry into the 7th grade when those vaccines became available and as recommended by ACIP, and is now adding a second dose of MCV in accordance with ACIP recommendations. As the Department has explained, the addition of pertussis to the list is made de facto due to the fact that single antigen diphtheria, tetanus and pertussis immunizations are not available in the United States. Currently, a child will either receive DTaP or Tdap to meet the requirement in the existing regulations that children be immunized against diphtheria and tetanus, depending upon the age of the child and previous vaccination status in accordance with ACIP recommendations, unless he has a contraindication to the pertussis component. Pink Book, p. 114. A child who has a contraindication to the pertussis component of the vaccine may obtain the DT vaccination to finish the DTaP series, and, for entry into the 7th grade, may obtain a medical exemption from the Tdap vaccination. The Department added Tdap to the list of immunizations required for entry into the 7th grade in 2011 to account for the waning pertussis immunity being seen across the United States. See 40 Pa.B. 2747. If the child does not receive Tdap in the 7th grade, there is no alternative other than an exemption.

 The Department also acknowledges that an individual may indeed choose to refuse a certain medical treatment for the individual or the individual's children, but notes that that choice may have consequences. For example, a person with tuberculosis may choose to refuse treatment, but if the person does so, the Department has the authority, by law, to quarantine that person until he undergoes medical treatment or recovers. See section 11 of the Disease Prevention and Control Law of 1955. In this case, the General Assembly has given the Department the authority to set a list of diseases against which children shall be vaccinated to attend school. If the parent refuses the vaccination for the child without a religious or medical exemption, the child may be excluded from school because, as with tuberculosis, the implications of the parent's choice go beyond the health of the child. Particularly in cases of mumps and of measles, the child's lack of immunity can seriously impact not only children who are unable to be vaccinated, but adults as well. The decision is still within the parent or guardian's purview to make.

Comments regarding accuracy of electronic medical records

 The commentator stated that at her son's 5 years of age well child checkup, the nurse refused to provide 5-year vaccinations that she had requested, and as a parent she knew her child needed the shots. Upon investigation of the electronic medical record, the commentator determined that the nurse was reviewing the wrong medical record. The commentator stated that she has had to correct her child's electronic vaccination records showing dated, hand-written copies as documentation.

 The Department acknowledges the commentator's concerns regarding accuracy of records and information. The Department cannot and does not regulate the use of medical records in physician offices.

Comments regarding specific sections of this final-form rulemaking

§ 23.82. Definitions

 IRRC requested that the Department make clear its use of ''health care provider'' in the definition of ''medical certificate'' to clarify which professions may fill out and sign a medical certificate.

 The Department revised this definition. The Department intends for only those practitioners within whose scope of practice diagnosis or examination fall to be able to make a determination of the appropriateness of the scheduling of future vaccines and to sign the medical certificate. The Department revised the definition of ''medical certificate'' to clarify that only a physician, CRNP or PA may sign that medical certificate. The Department notes that in a situation when the immunizations are being received from the Department, or a local health department, a public health official may sign the medical certificate, as they may sign the certificate of immunization.

§ 23.83. Immunization requirements

§ 23.83(a)—Duties of a school director, superintendent, principal or other person in charge of a public, private, parochial or nonpublic school

 Three commentators suggested that school administrators be required to ''buy-in'' to the regulations and that repercussions should occur if the immunization laws were not followed. One of these commentators stated that in the 2015-2016 school year, she had 30 of 190 kindergarten students who were not fully immunized. Under the 5-day provisional rule, she would have had to exclude those students. She would have needed the support of her school administrator.

 One commentator requested that the Department enforce the regulation regarding medical certificates and noted that although the Philadelphia School District would not exclude a child who lacked the required immunizations, she herself excluded a child transferring from that district for that reason. She complained that it is unfair that those who enforce the immunization laws, and who are stretched to the limit by having so much to do in the school health setting, to have to deal with school districts in this Commonwealth who ignore them.

 Several commentators, including PSEA, stated that they supported the proposed rulemaking and recommended that the regulations state ''shall exclude'' rather than ''may exclude.'' According to several commentators, unless exclusion is required, school districts will not exclude, and there will be no change for the better. One commentator noted that the administrators in her school district take their exclusion responsibility seriously, but this has not always been the case. One commentator wondered why the Department would go to the trouble to amend the regulation and then leave a loop hole for administrators to use. PSEA stated that without this language, there would not be consistent application across this Commonwealth or even across school buildings. PSEA stated that even though the provision was intended to provide local discretion, the effect is to undermine the goal of achieving optimal immunization levels for students.

 IRRC asked why the Department would allow discretion when requiring immunizations for attendance. IRRC asked the Department to explain the reasonableness of providing flexibility in the regulation and how allowing nonimmunized children to attend school adequately protects the public's health.

 Two commentators stated that the Department should change ''may'' to ''will'' in proposed § 23.85(e)(1)—''the child may not be admitted to school, unless the child has at least one dose of the multiple dose. . . .''

 The proposed rulemaking did require exclusion of children not meeting immunization requirements. The term ''may not'' used in a regulatory context is a prohibition on an action. ''May not'' denotes the curtailment of a right, power or privilege'' under § 6.7 (relating to use of ''shall,'' ''will,'' ''must'' and ''may'') of the Pennsylvania Code and Bulletin Style Manual. The Department revised § 23.85(e)(1) to emphasize that, even though obtaining certain immunizations to attend school is a requirement, a school administrator or a designee may provisionally admit a child under certain circumstances. Under this final-form rulemaking, a child who lacks the single dose of a single dose vaccine, or who does not meet the requirements for provisional admittance for multiple dose vaccines under § 23.85(e)(1), may not be admitted to school, absent a medical or religious/philosophical exemption or under another waiver provision. See § 23.85(e)(2) and (g). The Department notes that the only required vaccination that meets this single dose definition is Tdap.

 In addition, the Department acknowledges the hard and dedicated work of school nurses in this Commonwealth, and understands that they may at times be frustrated. The Department notes that enforcement of these provisions is not an easy matter. The enforcement provisions of the Public School Code of 1949 and the various public health statutes under which the Department derives its authority to require certain immunizations for school entry and attendance with Board approval make violation of those statutory provisions a summary offense, with corresponding monetary fines or imprisonment. See section 1303(b) of the Public School Code of 1949,⁹ section 16(a)(6) of the Disease Prevention and Control Law of 1955, section 20 of the Disease Prevention and Control Law of 1955 (35 P.S. § 521.20), section 2111(c.1) of The Administrative Code of 1929 and section 16 of the act of April 27, 1905 (P.L. 312, No. 218) (71 P.S. § 1409). Some of these statutes date back to 1905, a time period when failure to comply with certain orders of health departments were considered to be akin to criminal offenses because of the severity of the consequences attendant on ignoring those orders (for example, failure to comply with an immunization requirement for smallpox, an easily spread disease with an extremely high mortality rate (between 20% and 50%)).

 Although these penalty provisions remain available at the present time, the Department has not used one in recent memory. The Department's position in areas of compliance with public health laws has been that cooperation and voluntary compliance are more effective than coercion, and this holds true for immunizations and at the local level as well. For the Department or the Department of Education to take action to force a school administrator to enforce the regulations in a particular way would require the Department to file a private criminal complaint, seek the approval of the local district attorney to prosecute the case and would, at the least, impinge upon local control of schools. School administrators know their student populations and how to reach those populations better than the Department does or could. Allowing school administrators to encourage voluntary compliance from their school populations in a way best suited to the unique local needs of those populations is, in the Department's opinion, the best way to ensure that there is compliance with the requirements, and, therefore, that students are appropriately protected. The Department notes that the Department itself can, under its public health authority, exclude children and ''susceptibles'' (that is, persons lacking immunity from a particular disease, whether because of lack of vaccination or waning immunity) from schools during an outbreak of disease. See Chapter 27, Subchapter C and sections 3(a), 7 and 11 of the Disease Prevention and Control Law of 1955. The day-to-day decisions regarding administration of school immunization requirements more appropriately rest with school administrators and their designees. Section 1303(a) of the Public School Code of 1949 states that ''[i]t shall be the duty of all school directors, superintendents, principals, or other persons in charge of any public, private, parochial, or other school including kindergarten, to ascertain that every child, prior to admission to school for the first time has been immunized. . .'' (emphasis added).

§ 23.83(b)—Required for attendance

General

 One commentator stated that a child at 7 years of age beginning a series of DTaP would not get four doses of pertussis, the child would only get one dose of Tdap, and asked if this was correct. The commentator referenced the Department's current regulations and guidance manual for school nurses and noted that it provides the amount of adult tetanus and diphtheria toxoid (Td) needed, but not pertussis vaccine. She asked if there would be a section such as this in the new manual, because she did not believe this followed ACIP guidelines.

 The commentator is correct that for children 7 years of age and older, ACIP recommends that a child would not get four doses, and would get one dose of Tdap:

Vaccines containing reduced diphtheria (i.e., Td and Tdap) are indicated for children 7 years and older and for adults. A primary series is three or four doses, depending on whether the person has received prior doses of diphtheria-containing vaccine, and the age these doses were administered. . . . For unvaccinated persons 7 years and older. . .the primary series is three doses. The first two doses should be separated by at least 4 weeks, and the third dose given at 6 to 12 months after the second. ACIP recommends that one of these doses (preferably the first) be administered as Tdap.

 Pink Book, p. 114. A child entering the 7th grade who cannot receive a dose of Tdap would need to obtain an exemption; the Department added Tdap to the list of immunizations required for entry into the 7th grade in 2011 to account for the waning pertussis immunity being seen across the United States. See 40 Pa.B. 2747.

 The Department will update its immunization manual for school nurses upon approval of this final-form rulemaking. The Department believes its regulations follow ACIP requirements and will ensure that the updated manual does as well.

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⁹  This section does not specify whether the prosecution would be carried out at the instigation of the Department or the Department of Education, or both.

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