The Food and Drug Administration (FDA) confirmed that it could revoke Pfizer's authorization to provide COVID-19 vaccine shots to healthy children under the age of five.
If the revocation does occur, it could limit parents' vaccine options for their children ahead of the winter respiratory virus season. The situation comes months after President Donald Trump's Department of Health and Human Services (HHS) started implementing limits on COVID-19 vaccines.
Pfizer's COVID-19 Vaccine
Since 2021, updated coronavirus vaccines have been made available in the fall for the majority of American citizens before the cold sets in. The FDA recently told Pfizer that it may not renew the emergency use authorization (EUA) for the company's COVID-19 vaccine Comirnaty for children aged six months to four years.
A spokesperson for Pfizer said they are currently in discussions with the FDA on potential paths moving forward. They have already requested that the EUA for this particular age group remain in place for the 2025-26 season, according to USA Today.
The spokesperson added that it is crucial for them to note that the deliberations between the two organizations are not related to the safety and efficacy of the vaccine in question. The shot continues to demonstrate a favorable profile in keeping children safe.
On the other hand, a spokesperson for the HHS, Andrew Nixon, declined to predict what the agency might do moving forward. He said they cannot comment on potential, future regulatory changes. He noted that unless it is announced by the agency, discussion about future agency action should be regarded as pure speculation.
Potential To Not Renew Authorization
The situation comes as Pfizer expects the FDA to approve its vaccine for children aged five to 11 with the same limitations as Moderna and Novavax. In July, the FDA approved Moderna's shot for children aged six months and older, but only if they have a health condition that makes them more likely to have severe COVID-19, The Hill reported.
The idea of the FDA revoking emergency authorization on a product if a competitor gains approval for an alternative is not unusual. Additionally, Pfizer has not yet applied for full approval of its COVID-19 vaccine for the youngest age group.
The HHS's restrictions come as Secretary Robert F. Kennedy Jr., who is a prominent vaccine skeptic, worked to change and undermine immunization policy. He has continuously targeted COVID-19 vaccines and was the one who filed a petition in May 2021 demanding that the FDA revoke authorization for the shots, as per CNBC.
