CDC Advisory Panel Recommends Adding COVID Shots to Child Vaccination Schedule Without FDA License for Use in Children Under 12
On Oct. 20, 2022, the Advisory Committee on Immunization Practices (ACIP) voted 15-0 to add the mRNA COVID-19 shots to the list of vaccines recommended by the U.S. Centers for Disease Control and Prevention (CDC) for children as young as six months old, even though no COVID vaccine has been officially licensed by the U.S. Food and Drug Administration (FDA) for use by children under age 12. Currently, the Pfizer/BioNTech messenger RNA (mRNA) Comirnaty biologic and Moderna/NIAID’s mRNA Spikevax biologic are being distributed under an Emergency Use Authorization (EUA) for children over age 12 years old (Pfizer) and for individuals over age 18 (Moderna). 1 2 3 4 5
The CDC usually follows the counsel of its vaccine advisory panel, whose members are appointed by the Secretary of the U.S. Department of Health and Human Services (DHHS). The CDC staff is
expected to officially sign off on the ACIP recommendation and add the shots to the new childhood vaccination schedule published in February 2023.6The COVID vaccine is the first vaccine that has been widely distributed in the U.S. under an EUA, rather than meeting evidence criteria that legally allows the FDA to grant full licensure. COVID vaccine is also the first EUA-approved vaccine to be added to the CDC’s recommended child vaccine schedule for children as young as six months old, even though it has not been licensed for children under age 12. On the FDA website, federal health officials state:
Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.7
States Mandate Vaccines, Not the CDC
Neither the recommendation by the ACIP nor whatever decision the CDC ultimately takes regarding adding COVID vaccine to the recommended childhood vaccine schedule would require that students receive COVID shots before enrolling in school. The CDC does not have the legal authority to mandate vaccines nationally and confirms on its website that it “only makes recommendations for use of vaccines, while school-entry vaccination requirements are determined by state or local jurisdictions.” In the U.S., most public health laws, including vaccine laws, are enacted by state legislatures or, in some states, the authority to add CDC recommended vaccines to school attendance requirements has been handed to state health department officials by the state legislature.2 8
After the FDA granted Pfizer and Moderna an EUA to distribute their mRNA COVID biologicals in the U.S. in December 2020, there were efforts in 2021 and 2022 at the federal level to mandate the vaccine for federal workers and contractors, but it has been challenged and temporarily blocked in the courts. In 2021, the only COVID vaccine mandates enacted were created by state governors, state or local officials, or by private employers. No state legislature mandated the COVID vaccine for children to attend school this year.9 10
NVIC Opposed to COVID Vaccine Mandates
On Oct. 19, Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC) submitted a referenced public comment to the CDC on behalf of NVIC opposing the addition of COVID vaccine to the federally recommended childhood vaccine schedule and cited that (1) FDA has not licensed the COVID vaccine for children under age 12; (2) there have been more than 1.3 million adverse events following receipt of mRNA COVID vaccinations to the federal Vaccine Adverse Event Reporting System (VAERS); (3) mRNA COVID vaccine was fast tracked and distributed under an EUA before full scientific evaluation of the product’s ability to prevent symptomatic and asymptomatic infection and transmission of SARS-CoV-2 and without full scientific evaluation of the product’s ability to cause serious complications, including inflammation of the heart and other reactions that may cause sudden death; and (4) there has been widespread acknowledgement that SARS-CoV-2 infections in the majority of children are asymptomatic or mildly symptomatic and rarely cause injury or death, and (5) the COVID vaccine is available for parents who choose to give it to their children.
After the ACIP vote, Fisher made the following statement:
The novel mRNA COVID biological product, which is notoriously reactive and also ineffective at blocking infection and transmission of SARS-CoV-2, continues to be distributed to young children under an Emergency Use Authorization (EUA) granted by the FDA. I suppose we should not be surprised that the ACIP has voted to add it to the CDC’s recommended childhood vaccine schedule, even though it has not been fully licensed by FDA for use in children.3
She added:
The past three years has taught us that federal health officials have politicized the COVID vaccine development, licensing and policymaking process and rubber-stamped the questionable science provided by pharmaceutical companies. Now it is up to parents to let their state legislators know they want vaccine informed consent protections in public health laws and are opposed being forced to give their children the COVID vaccine as a condition of attending school, receiving medical care or for any other reason.3
ACIP Vaccine Recommendations Often Become State Mandates for School Attendance
While ACIP and CDC vaccination recommendations do not carry the weight of law, they are often adopted as law by state legislatures. According to NVIC, which has operated the online NVIC Advocacy Portal since 2010 to help residents in every state secure and defend informed consent protections in vaccines laws:
[H]istorically, after a new vaccine is put on the CDC’s childhood vaccine schedule and recommended for universal use by all children, there is an immediate push by lobbyists representing public health officials, medical trade associations and institutions committed to mandatory use of all government recommended vaccines to add the vaccine to state law requirements for daycare and school attendance.2
In the past two years, a number of states have enacted laws that specifically protect students and others from COVID vaccine mandates. Currently, 21 states in the U.S. prohibit forcing students to get COVID shots as a requirement to attend school, either through legislation or by executive order. Three states prohibit school COVID vaccine mandates for students under 12 years old. Twenty-six states have no prohibition for any ages. But this can change (either way) depending on the political makeup of state legislatures and governorships.11
As NVIC points out, in the past decade “a number of states have removed or restricted vaccine exemptions and some state health departments have been given the authority to automatically add vaccines included on the CDC’s recommended childhood vaccine schedule to legal requirements for children to attend daycare and school.”3
While no state has yet to implement a COVID vaccine mandate for children to attend school, the District of Columbia passed a COVID vaccine mandate that applies to children attending school this year. That mandate is being challenged in Congress. California does have a COVID vaccine mandate pending. Students in California will not be required to receive COVID shots during this school year, but may be required to get the shots as early as July 1, 2023.12 13
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