I do not support the requested action to mandate vaccines for students.

My understanding of the petition is summarized below.

Requested Action:

Petition requests that the board mandate vaccines for all school employees, with only medical exemptions allowed, and for all students for whom the vaccine has been fully approved, just as many other vaccines are mandated.

Justification provided in the petition for the requested action.

1. we are already seeing constant disruptions to education for far too many due to infections, possible infections based on symptoms, and mandatory quarantines.

2. [All] students should have a right to be able to attend school without being unnecessarily put at risk by other students and teachers who refuse to be vaccinated, and without constant disruptions to their education.

3. And it sure would be great for them to be able to go to school without masks and without worrying about lunch and other unmasked times, as well as overcrowded busses.

4. The irrational minority should not be dictating the public health policy for VA or the schools.

The petition appears to request amendment of the Code of Virginia, Chapter 110. “Regulations for the Immunization of School Children,” and in particular, Sections 70, “Immunization requirements” and 80 “Exemptions from immunization requirements”, as well as additional amendments of other regulations that support the applicable requirements in, cite or refer to these Sections.

The petition makes a broad request to require vaccines for school employees and students, but does not specify which vaccines should be mandated, other than specifying that the vaccines be “fully approved” for the students. News articles have conveyed that this petition is a request to mandate COVID-19 vaccinations, but the petition does not mention COVID-19 nor specify (if that was the intent) which of the currently available COVID-19 vaccines should be required.

The following comments apply to the portion of the request regarding mandating vaccinations for students.  I do not have any comments regarding the request to mandate vaccinations for teachers.

As a general principle, a petition such as this should not be granted if the requested action is already met by existing requirements or regulations. The following is a brief summary of select existing regulations in the Code of Virginia applicable to requirements for student vaccinations.

The Code of Virginia includes regulations applicable to vaccinations for Students attending school in Virginia and for the Virginia Board of Health to establish rules and regulations regarding immunization requirements. Specifically, the Code of Virginia, Section § 22.1-271.2. “Immunization requirements” and the Virginia Administrative Code 12VAC5-110-70. “Immunization requirements” identify multiple vaccinations that are required for all Students to attend school in Virginia, unless the student is exempted from immunization pursuant to § 22.1-271.2., subsection C and Section 80 of 12VAC5-110. Paragraph G. of Section § 22.1-271.2 specifies that “The Board of Health shall promulgate rules and regulations for the implementation of this section in congruence with rules and regulations of the Board of Health promulgated under § 32.1-46 and in cooperation with the Board of Education.”

The Code of Virginia, Section § 32.1-46. “Immunization of patients against certain diseases” requires that “each child within this Commonwealth [shall be] immunized in accordance with the Immunization Schedule developed and published by the Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP).” Paragraph C. of this section requires “The vaccines required by this section shall meet the standards prescribed in, and be administered in accordance with, the State Board of Health Regulations for the Immunization of School Children. The State Board of Health shall amend the State Board of Health Regulations for the Immunization of School Children as necessary from time to time to maintain conformity with evidence-based, routinely recommended vaccinations for children.” (emphasis added). With respect to exemptions from these requirements, Paragraph D. of specifies that the requirements in this section “shall not apply if:

1. The parent or guardian of the child objects thereto on the grounds that the administration of immunizing agents conflicts with his religious tenets or practices, unless an emergency or epidemic of disease has been declared by the Board;

2. The parent or guardian presents a statement from a physician licensed to practice medicine in Virginia, a licensed nurse practitioner, or a local health department that states that the physical condition of the child is such that the administration of one or more of the required immunizing agents would be detrimental to the health of the child;”

In addition, Section 80 of 12VAC5-110 provides the following exemptions from the immunization requirements:

A. Religious and medical exemptions:

1. The student or his parent or guardian submits a notarized Certificate of Religious Exemption (Form CRE 1), to the admitting official of the school to which the student is seeking admission.

2. The school has written certification on either of the documents specified under "documentary proof" in 12VAC5-110-10 from a physician, registered nurse, or a local health department that one or more of the required immunizations may be detrimental to the student's health.

B. Demonstration of existing immunity. The demonstration in a student of antibodies against mumps, measles, rubella, or varicella in sufficient quantity to ensure protection of that student against that disease, shall render that student exempt from the immunization requirements contained in 12VAC5-110-70 for the disease in question.

Note that paragraph A also authorizes upon the identification of an outbreak, potential epidemic, or epidemic of a vaccine-preventable disease in a public or private school, that the commissioner has the authority to require the exclusion from such school of all children who are not immunized against that disease, but does not allow mandating that children with one of the approved exemptions must receive a vaccination. This provision is also addressed in § 22.1-272. “Contagious and infectious diseases.”

In addition, paragraph B recognizes that demonstrated protection from infectious diseases from a prior protection can be equivalent to, if not more effective than an immunization.

Conclusion:

With respect to the action requested by the petition for the board to mandate vaccines for all students, the request is already met by the existing regulations in the Code of Virginia described above. As such, no further action is needed and none should be considered under this petition.

With respect to the request that only medical exemptions be allowed, this would require amending the current regulations, and can be considered under the petition. However, the existing regulations provide longstanding exemptions that are based on strongly held religious beliefs (i.e., religious freedom provided by the United States Constitution and Virginia Constitution), potential harm that could be incurred due to an existing medical condition, and alternative means to demonstrate that an individual is already protected from the infections agent. The regulations also provide a means for the case by case basis protection of students with existing exemptions in situations where an outbreak occurs within their school. The petition does not address whether these existing exemptions are or are not appropriate, why they should be removed or revised, whether they are sufficient to protect the students, and does not address why the existing exemption provisions would “unnecessarily put [students] at risk.” The petition also does not address why protections provided by prior infections that provide natural immunity should not be allowed or would “unnecessarily put [students] at risk.” There is no compelling basis provided for revising the existing exemptions; therefore, the board should not consider changing the existing regulations based on the petition. The purpose of the required immunizations is to protect the students, which can be effectively accomplished by having them stay out of the school during an outbreak. With the continuing ability of students to utilize remote learning, this can also be accomplished without compromising the student’s ability to continue their studies.

Although not specified by the petition, the remaining comments address the “implied” request to mandate that students be vaccinated against COVID-19.

It is clear in Jacobson v. Massachusetts that state governments have the authority to enforce laws that require their citizens to be immunized, and the existing regulations described above clearly provide the process and requirements in the State of Virginia to require certain for vaccinations for students.

A key premise of the Jacobson v. Massachusetts decision is that a state can limit individual rights to support a public health necessity through reasonable regulation.

So the questions that must be considered before taking the actions requested in the petition must be:
  1. Is there a public health necessity that requires the board to take action now?
  2. if so, is a mandate that all teachers and students must be vaccinated against COVID-19, as discussed in the proposed action, the only reasonable regulation available to address the public health necessity.

To grant the proposed action, both of these must be answered in the affirmative.

It is clear that the COVID-19 pandemic has presented a clear public health emergency, consistent with the declaration of a “STATE OF EMERGENCY DUE TO NOVEL CORONAVIRUS (COVID-19)” in Virginia. This declaration implemented or resulted in numerous actions to protect the citizens of Virginia during the public health emergency, and those actions been renewed and amended multiple times. These actions have included requiring remote learning for Virginia public schools through most of the 2020 school year, the August 12, 2021, declaration by the State Health Commissioner for a Statewide Requirement to Wear Masks in K-12 Schools, and making available to and the distribution of COVID-19 vaccines to all Virginia eligible to receive the vaccines under the FDA emergency use approval. Such actions have been effective in reducing the spread of COVID-19 and protecting individuals who contract COVID-19. Until mid-2021, these vaccines were only available for adults19 years and older. This was appropriate due to the high level of sensitivity of children 18 years and younger to vaccines and other medications, and the need for caution when approving vaccines for use on children due to the high level of uncertainty as to the short and long term affects they may have in children.

As indicated above, Section § 32.1-46 of the Code of Virginia requires that “each child within this Commonwealth [shall be] immunized in accordance with the Immunization Schedule developed and published by the Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP). None of the Immunization Schedules developed by these organizations currently list immunization against COVID-19. However, based on a recommendation from the ACIP the CDC, AAP, and AAFP, each recommend use of COVID-19 vaccines for everyone ages 12 and older within the scope of the Emergency Use Authorization for the particular vaccine. Currently, only the Pfizer-BioNTech vaccine is authorized and recommended for persons aged ≥12 years and the Moderna and Janssen vaccines are only authorized and recommended for persons aged ≥18 years. A modified version of the Pfizer-BioNTech COVID-19 Vaccine has been approved (i.e., not an emergency authorization), and is marketed as Comirnaty. The Comirnaty vaccine was approved by the FDA on August 23, 2021 for the prevention of COVID-19 disease in individuals 16 years of age and older. The FDA states that these vaccines are legally distinct with certain differences that do not impact safety or effectiveness. However, only the Comirnaty formulation is “fully approved” by the FDA, and is only authorized for people 16 years or older. Currently, the Comirnaty vaccine is not widely available, and will likely not be available for many months as Phizer ramps up its production.

An individual’s decision to take a vaccine approved under an FDA emergency use authorization is required to be voluntary. The authorizations issued for each of the three currently approved COVID-19 vaccines were issued consistent with this FDA requirement. As such, a vaccine approved under an FDA emergency use authorization should not be included as a required immunization for entry in a Virginia school. Doing so would be contrary to the FDA regulation and emergency use authorization. However, doing so may be appropriate in very limited circumstances, such as when the risk posed by the infectious agent is significant (i.e., can result in sever complications or death) to a large portion of students if not protected. The existing requirements for immunization are for infectious agents that can result in such significant risks, and each has an FDA approved vaccine that has been shown through significant testing, FDA evaluation, and years of use to be safe for use in children. None are approved under emergency use. Requiring a vaccine for children that has been approved under an FDA emergency authorization should only be considered when there is a clear and demonstrated threat to the children that can only be mitigated by the vaccine.

Although the latest ACIP report (August 2021) recommends the COVID-19 vaccines for persons >12 years old, the ACIP provides no information on the potential detrimental effects on children from 12-18 years of age. The ACIP provides only information concerning affects for adults greater than 18 years old. However, a search of the CDC VARS database for reports of “Serious” (potentially life threatening) events involving children 18 years old or younger for all three of the current COVID-19 vaccines provided 1,299 reports, including numerous deaths. This is likely due to the use of the vaccine for children down to 12 years old only being approved shortly before their August report was issued. The ACIP has not issued any additional updates since August, and does not plan to issue another update until late in the month of October.

To date, the CDC Reports 419 “provisional” deaths from COVID-19 infection for persons between the ages of 5-18 years old. This represents a death rate of 0.00078% for the ~54 million children in the US between ages 5-18 years and 0.06% of all COVID-19 related deaths in the US. For adults 19-44 years old, the death from COVID-19 increase to 25,952. The current case-fatality rate in the US (deaths/known COVID-19 cases) is 1.6%, while the overall death rate in the US from COVID-19 (deaths/total population) is 0.22% (see Mortality Analyses - Johns Hopkins Coronavirus Resource Center (jhu.edu)). In comparison, the case-fatality rate for influenza is similar to or greater than that of COVID-19 for children. Although influenza vaccinations are listed in the immunization schedules for the CDC, ACIP, AAP, and AAFP, they are not generally listed as required immunizations for students due to the low risk that influenza presents to persons 18 years old or younger.

The above statistics provides strong evidence that COVID-19 is not a significant health threat to children of 18 years or younger. The CDC also does not have evidence of a significant percentage of children less than 18 years old who have had COVID-19 having serious complications from the virus, with the vast majority being asymptomatic. This provides strong evidence that children may actually be at greater risk from experiencing serious, potentially life-threatening complications from getting a COVID-19 vaccine than from having serious complications or dying from contracting COVID-19.

In addition to the above, the CDC and NIH are currently reviewing alternative treatments that could be effective against COVID-19, some of which are existing medicines that have a long track record of being safe for persons of all ages. As such, prior to considering an immunization requirement for COVID-19, the Board of Health should also consider the effectiveness of these alternative treatments and whether they could provide equivalent protection for students. See the following links for information on the CDC and NIH investigations concerning alternative treatments for COVID-19 (Therapeutic Options for COVID-19 Patients | CDC, COVID-19 Treatments | NIH COVID-19 Research and Available COVID-19 Treatment Options | combatCOVID.hhs.gov).

Summary of Conclusions:

There is strong evidence that COVID-19 is not a significant health threat to children of 18 years or younger. Therefore, additional actions to protect students from COVID-19, beyond those already taken, are not necessary.

Mandating that all students must be vaccinated against COVID-19 may be at greater risk from complications from the vaccines than would be posed from an infection from COVID-19. If students do develop systems from COVID-19 (many are asymptomatic), there are alternative treatments available that would pose a lower risk than the current vaccines. Little to no information is available on the potential long term effects on children from the currently available COVID-19 vaccines.

With respect to the action requested by the petition for the board to mandate vaccines for all students, the request is already met by the existing regulations in the Code of Virginia described above. As such, no further action is needed and none should be considered under this petition.

With respect to the request that only medical exemptions be allowed, the existing regulations provide longstanding exemptions and the petition did not provide any compelling basis for revising or removing any of the existing exemptions. The board should not consider changing the existing regulations based on the petition.

The petition does not provide any supporting facts that would justify the requested actions, the bases provided for the requested actions are not fact based nor are based on scientific evidence. When actual scientific evidence is considered, there is not a sufficient basis to take the action requested.