The FDA has denied two citizen petitions filed on behalf of the Informed Consent Action Network (ICAN) requesting the agency revoke its Emergency Use Authorizations (EUAs) for the use of the Pfizer-BioNTech and Moderna COVID-19 vaccines for children ages 5-17.
In its denials, the Agency amalgamated a detailed body of the bases for its EUA authorities and decisions that is not limited to the individual petitions, but rather provides high value maps of the EUA landscape and FDA’s thought process in navigating it.
A detailed analysis of the petitions and denials can be found here. At a high level, the petitions and FDA’s denial can be summarized as follows:
1. There are four criteria for issuance of an EUA:
- An agent (here, the SARS-CoV-2 virus) can cause a serious or life-threatening disease or condition (here, COVID-19).
- There is sufficient evidence that the product (here, the vaccines) may be effective in diagnosing, treating, or preventing the life-threatening disease or condition.
- The known and potential benefits of the product outweigh the known and potential risks.
- There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.
2. FDA has permissive, not mandatory, authority to revoke an EUA under any of three conditions:
- The circumstances described in the Declaration no longer exist
- The four criteria under for issuance of such authorization are no longer met.
- Circumstances make such revision or revocation appropriate to protect the public health or safety.
3. The criteria for issuance of the EUA continue to be met
- COVID-19 is a serious or life-threatening disease or condition
In asking FDA to revoke the EUAs for individuals 5-17 years of age, ICAN asserted that there is “no health emergency” for children. However, FDA noted that section 564(b)(1)(C) of the FD&C Act does not contemplate separate public health emergency determinations by age group. Rather, it addresses the threat to the population as a whole.
Thus, in order to show grounds for revocation of the EUA for individuals aged 5-17, the petitions would have had to demonstrate that the circumstances writ large for the EUA no longer exist. Since the petitions made no such argument or showing, they failed to meet the first condition.
- There is sufficient evidence of effectiveness.
Petitioners asserted that the testing for children and adolescents was inadequate because “it was limited to assessing antibody levels and comparing those levels to adult levels using immunobridging.” However, describing in the studies in detail, FDA noted that they indeed included safety and effectiveness data from children and adolescents. In addition, to the extent they also used immunobridging, FDA noted that it is well-established regulatory precedent with other preventive vaccines. For these reasons, FDA found the petitions failed to establish the second criterion was no longer met.
- The benefits outweigh the risks.
The petitioners lodged numerous objections to the adequacy of clinical trial safety data for children and adolescents used in determining that the benefits of the vaccines outweigh the risks. FDA responded with a detailed reply setting out the following: that the determination was properly supported by pre-evaluation of age-specific study plans and protocols, assessment of sufficiently representative trials that follow FDA’s EUA Vaccine Guidance, and a focused review of safety data, in addition to ongoing analysis of all reported child and adolescent events showing them to be uncommon, representative of medical events expected, and not suggestive of a causal relationship to the medical product.
Moreover, FDA rejected out of hand the petitioner’s position that vaccines are required to show 100 percent effectiveness in order to have substantial benefit.
Finally, FDA rejected the petitioner’s citations to individual studies claiming to have discovered certain post-trial adverse events because the studies cited were not peer-reviewed and published, did not demonstrate the claims being made by ICAN, and were cited selectively in the Petition to ignore key statements that contravened their claims.
- There are no sufficient alternatives
The petitions did not assert that there are adequate and approved alternatives to the vaccines, but FDA nonetheless reconfirmed that, because the vaccines are the only FDA-approved drugs or biologics indicated to prevent COVID-19 in any population, there are in fact no adequate, approved and available alternatives.
4. There are no circumstances making such revision or revocation appropriate to protect the public health or safety.
The petitioners asserted, and FDA found, no circumstances making revision or revocation of the vaccine EUAs appropriate to protect the public health or safety.
The citizen petitions and FDA’s responses are available at Docket Number FDA-2022-P-1399 and Docket Number FDA-2022-P-0872.