This article about the FDA’s actions on a petition from ICAN to revoke EUAs for COVID-19 vaccines was written by Viridiana Ordonez. Ms. Ordonez has contributed other articles to this website and is a J.D. candidate at the University of California, Hastings College of Law.
Del Bigtree‘s Informed Consent Action Network (ICAN) submitted a Citizen Petition to the Food and Drug Administration (FDA) on September 27, 2021. In its petition, ICAN requested that the FDA revoke the Emergency Use Authorization (EUA) granted to ModernaTX, Inc. (Moderna) and JNJ Jansen Biotech, Inc. (Janssen) for their COVID-19 vaccines.
ICAN argued that because the FDA has now approved Comirnaty – the COVID-19 vaccine created by Pfizer-BioNTech – the requirements for issuance of the EUA for the other vaccines are no longer met.
The FDA replied to the petition on October 20, 2021, and rejected the request, explaining that ICAN’s petition did not contain facts demonstrating any reasonable grounds for its request. This post summarizes FDA’s response.
First, the FDA explained that the COVID-19 pandemic, caused by SARS-CoV-2, created extraordinary challenges to global health. As a result, the Department of Health and Human Services (HHS) issued a declaration of public health emergency on March 27, 2020. The Secretary declared these circumstances sufficient to issue an emergency use authorization (EUA) for a vaccine. The FDA described that since the start of the pandemic, it has taken the following actions:
- Issued EUAs for three vaccines to prevent COVID-19. These vaccines were sponsored by Pfizer, Moderna, and Janssen.
- Approved a Biologics Licensure Application (BLA) for Comirnaty (COVID-19 Vaccine, mRNA) to BioNTech Manufacturing GmbH specifically for use in individual sixteen years of age or older.
- Approved continued use of Comirnaty under the EUA for certain uses that are not included in Comirnaty BLA for Pfizer-BioNTech COVID-19 Vaccine.
- Reissued EUA for use of a single booster dose of Comirnaty or Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years or age or older, for other individuals at high risk, and for individuals frequently exposed to COVID-19.
Vaccines are safe
The FDA explained that the COVID-19 vaccines that are FDA-licensed or that received a EUA meet relevant statutory requirements that make them safe. First, the FDA has a stringent regulatory process for licensing vaccines because prior to approval, vaccines are extensively tested in non-clinical studies and in large clinical trials in people.
Additionally, a vaccine sponsor must submit extensive data to the FDA that demonstrates the product’s safety before the FDA will even consider licensing a vaccine. Some of that information includes evidence establishing the product’s safety, purity, and potency (as required in the public health service act), a description of manufacturing methods, and data establishing stability.
After this data is provided to the FDA, the FDA has review teams that evaluate the laboratory and clinical data along with other information to determine whether the standards have been met. Only then will the FDA license a vaccine. Thus, any vaccine used in the United States that has been approved by the FDA has been demonstrated to be safe for use.
Similar rigorous standards apply for the issuance of the EUA for a COVID-19 vaccine. The EUA was only issued when the statutory standards were met. The EUA exists for situations such as this pandemic and was established by Congress to provide potentially life-saving medical products before being approved.
Particularly, the FDA requires that a vaccine demonstrate clear and compelling safety and effectiveness in Phase 3 clinical trials. A Phase 3 trial is a large clinical trial in which many people receive the investigational vaccine or control, in this case, a saline placebo. The individuals in the study do not know who received the vaccine and who received the control.
During the study, individuals are monitored for safety events. The results of Phase 3 trials are then submitted to the FDA for support of the EUA request. Further, the FDA periodically reviews EUAs and can ultimately revise or revoke it at any time if it no longer meet the criteria.
Response to ICAN petition against COVID-19 vaccines EUA
ICAN argued that the EUA for Moderna and the Janssen COVID-19 vaccines must be revoked because the FDA approved Comirnaty, which is an adequate, approved, and viable alternative to the EUAs already issued for vaccines.
ICAN claimed that because Comirnaty is a viable alternative, the conditions permitting issuing EUAs for other COVID-19 vaccines (which include the absence of adequate viable alternatives) are no longer met. However, as the FDA explained, while these conditions are required to issue the EUA, the FD&C Act gives discretion to the FDA and the Act does not require the FDA to revoke a EUA simply because of the conditions that gave rise to their issuance are no longer applicable. While the FDA may revoke the EUA, it is not required.
Further, ICAN did not provide any data that shows that the availability of Comirnaty means that there is now an adequate, available, approved COVID-19 vaccine, making the continuation of the EUAs no longer justified. The opposite is true. T
he FDA explained that there is still a high demand for COVID-19 vaccines and having sufficient supply is essential to protect individuals against the disease. There is an unvaccinated and partially vaccinated population which indicates that there is still a need and demand for the vaccine.
For example, individuals who are partially vaccinated because they have received the first dose of the Moderna vaccine still require a second dose and ideally, must receive a second dose of the same vaccine to be fully vaccinated. Additionally, there are individuals who are immunocompromised that received both doses of the vaccine but will require a third dose as recommended and should receive the third dose of the same vaccine. The FDA anticipates that of the unvaccinated population, some will contribute to the demand for the vaccines approved under EUAs.
Additionally, unlike ICAN’s argument, Comirnaty may not be a viable alternative for all individuals as some will be allergic to some of the ingredients contained in Comirnaty. Specifically, Comirnaty is not recommended for individuals with a history of severe allergic reactions to ingredients contained in Comirnaty. Thus, the EUAs for other vaccines must remain in place to ensure that individuals with severe allergies have access to the COVID-19 vaccines authorized under EUA.
Finally, other considerations such as accessibility must be taken into consideration. The FDA explained that for some individuals who might experience difficulties accessing healthcare or for communities who are unable to provide the proper storage conditions for Comirnaty, the dose of the Janssen vaccine might be the best option. The Janssen vaccine requires one dose only and simpler storage requirements. The FDA also emphasized that the COVID-19 pandemic is not over, it is still evolving and still has the potential of impacting the availability of the vaccines.