The Food and Drug Administration is considering revoking its authorization of Pfizer's COVID-19 vaccine for healthy children under the age of 5, the drugmaker confirmed Tuesday. The potential move could leave many young children with no available protection against the virus, as alternative vaccines from Moderna and Novavax are cleared for more limited populations.
The FDA informed Pfizer it might not renew the longstanding emergency use authorization for children ages 6 months to 4 years, according to a company statement. Pfizer has requested the authorization remain in place for the upcoming fall and winter season and is "currently in discussions with the agency on potential paths forward."
Limited Vaccine Options for Young Children
If the FDA proceeds with revoking the authorization, it would remove the only remaining COVID vaccine available for all children under five from the market. Moderna's COVID vaccine received FDA approval in July for pediatric use, but only for children with one or more health conditions that increase their risk of severe illness. Novavax's protein-based shot has never been available for children under 12.
"It certainly would create a hole in the availability of vaccines," said Georges Benjamin, executive director of the American Public Health Association. "And to do it this late in the season – I think clearly it's inappropriate."
Safety Profile Remains Favorable
Pfizer emphasized that the FDA's deliberations are not related to the safety and efficacy of the shot, "which continues to demonstrate a favorable profile." The company noted that it expects its COVID vaccine for children aged five to 11 to be fully licensed this fall.
The vaccine has proven extremely effective, especially against hospitalization and death. However, vaccination rates remain low among young children, with only 5.6% of children aged six months to four years vaccinated against COVID-19, and about 15% of children aged five to 17 vaccinated, according to CDC data.
Ongoing Health Concerns
Despite lower vaccination rates, children continue experiencing hospitalization rates from COVID similar to levels seen in 2020 and 2021. While COVID typically causes mild symptoms in most children, infants under 1 and those with certain health conditions face higher risks of severe illness and hospitalization.
"We don't know the long-term impact for kids who have gotten Covid as a disease. We do know it does cause a multi-systemic inflammatory process in a number of kids, which is very severe, and we don't know the long-term implications for long Covid in kids," Benjamin explained.
Supply Chain Response
The Centers for Disease Control and Prevention is working with Moderna to address potential supply gaps. According to an email from the National Center for Immunization and Respiratory Diseases sent to state and local vaccination grantees, the CDC is "in discussions" with Moderna about rapidly increasing its COVID vaccine supply for young children, including internal planning about volume, timing, and potential supply gaps.
"We are working to ensure there will be sufficient supply," said Chris Ridley, a Moderna spokesperson.
Policy Context
The potential authorization revocation adds to recent efforts by U.S. health agencies to modify immunization policy since Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic, assumed leadership. Kennedy previously filed a petition in May 2021 demanding the FDA revoke authorization of mRNA COVID vaccines and announced in May that the CDC removed its recommendation of COVID vaccines for healthy children and pregnant women.
Benjamin noted that Kennedy's "unscientific statements about the safety and efficacy of vaccines, particularly Covid vaccines, for both pregnant women and kids" have "muddied the waters of what people know about the safety and efficacy of the vaccine."
