FDA Approves Pfizer Covid Vaccine but Adds Restrictions on Its Use

Health and Human Services Secretary Robert F. Kennedy Jr. said the FDA removed emergency use authorizations for Covid-19 vaccines. (Getty Images)

Health and Human Services Secretary Robert F. Kennedy Jr. said Wednesday that the U.S. Food and Drug Administration rescinded the emergency use authorizations for Covid-19 vaccines enacted under the previous administration and limited the availability of Pfizer’s shot to certain young children and adults.

“The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” Kennedy wrote on X.

While Moderna’s Covid vaccine is available to children as young as 6 months, the orders limit the availability of the Pfizer vaccine to those aged 5 and older. The Novavax vaccine, meanwhile, is available to those aged 12 and up.

The stricter limits mark a departure from policy under the Biden administration that recommended an annual Covid shot for all Americans aged 6 months and older.

“The American people demanded science, safety, and common sense,” Kennedy wrote. “This framework delivers all three.” The FDA itself has yet to issue a formal announcement reflecting the changes.

Also on Wednesday, the FDA approved a supplemental Biologics License Application for Pfizer’s updated Covid shot, which is available under the brand name Comirnaty.

The application pertains to patients aged 65 and older, as well as people aged 5 through 64 years with at least one underlying condition “that puts them at high risk for severe outcomes from COVID-19.”

Questions remain regarding the availability for otherwise healthy people without preexisting conditions, and whether insurance plans will continue to cover the vaccine for those people.

The development came as no surprise to the market. Stocks barely budged: Moderna and Pfizer were flat and up 0.4%, respectively, while Novavax was down 0.6%. The Health Care Select Sector SPDR exchange-traded fund , which counts Pfizer among its major holdings, was up slightly.

Write to Mackenzie Tatananni at mackenzie.tatananni@barrons.com