FDA may pull authorization of Pfizer Covid shot for youngsters under 5

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 kids, others, equivalent to infants under 1 or those with certain health conditions, could be at the next risk of severe illness and hospitalization.

If the FDA pulls the authorization, it could add to a string of recent efforts by U.S. health agencies to alter and undermine immunization policy since Health and Human Services Secretary Robert F. Kennedy Jr., a distinguished vaccine skeptic, took the helm. HHS didn’t immediately reply to a request for comment.

The FDA told Pfizer it won’t renew its longstanding emergency use authorization for youngsters ages 6 months to 4 years, the corporate said in a press release. Pfizer said it has requested the authorization to stay in place for the upcoming fall and winter season and is “currently in discussions with the agency on potential paths forward.”

The corporate said that the FDA’s “deliberations” will not be related to the security and efficacy of the shot, “which continues to display a good profile.”

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

In July, the FDA granted full approval to Moderna’s Covid vaccine for youngsters — but just for those with another more health conditions that will put them at increased risk of severe illness in the event that they develop into infected. The shots from each Moderna and Pfizer use messenger RNA technology.

Kennedy has targeted those vaccines up to now, 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 youngsters under 12. 

In May, Kennedy announced that the Centers for Disease Control and Prevention has removed its suggestion 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 health care provider agreed that it was needed. Covid vaccines while pregnant at the moment are listed as “No Guidance/Not Applicable,” where they were previously really useful for all pregnant adults.