FDA may pull authorization of Pfizer’s Covid vaccine for children under 5, company says

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 to CNBC on Tuesday. 

The move could leave many kids with no available shot against the virus, as jabs from Moderna and Novavax are cleared for more limited populations. While Covid typically causes mild symptoms in most children, others, such as infants under 1 or those with certain health conditions, can be at a higher risk of severe illness and hospitalization.

If the FDA pulls the authorization, it would add to a string of recent efforts by U.S. health agencies to change and undermine immunization policy since Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic, took the helm. HHS did not immediately respond to a request for comment.

The FDA told Pfizer it might not renew its longstanding emergency use authorization for children ages 6 months to 4 years, the company said in a statement. Pfizer said it has requested the authorization to remain in place for the upcoming fall and winter season and is “currently in discussions with the agency on potential paths forward.”

The company said that the FDA’s “deliberations” are not related to the safety and efficacy of the shot, “which continues to demonstrate a favorable profile.”

The Guardian first reported on the FDA’s potential move. Moderna is working with the Centers for Disease Control and Prevention to boost supplies of its own Covid shot for children, the Guardian reported Saturday.

In July, the FDA granted full approval to Moderna’s Covid vaccine for children — but only for those with one more more health conditions that may put them at increased risk of severe illness if they become infected. The shots from both Moderna and Pfizer use messenger RNA technology.

Kennedy has targeted those vaccines in the past, filing a petition in May 2021 demanding that the agency revoke authorization of the jabs.  

Meanwhile, Novavax‘s protein-based shot has never been available for children under 12. 

In May, Kennedy announced that the Centers for Disease Control and Prevention has removed its recommendation of Covid vaccines for healthy children and pregnant women. 

But in updated guidance days later, the CDC said the shots “may” be given to those kids if a doctor agreed that it was necessary. Covid vaccines during pregnancy are now listed as “No Guidance/Not Applicable,” where they were previously recommended for all pregnant adults.