Possible Moderna and Johnson & Johnson Boosters in U.S. Timing Is Murky

An advisory committee to the Food and Drug Administration is weighing the merits of Pfizer-BioNTech’s application on Friday to provide third shots of its coronavirus vaccine to people 16 and older. But there is still no clear timeline for when the F.D.A. might consider signing off on booster shots for the two other vaccines available for use in the United States.

Moderna and Johnson & Johnson make those vaccines, which have both been authorized for emergency use by the F.D.A. for those 18 and older. (Pfizer’s vaccine is the only one that has been fully approved for use in people 16 and older; it is available under emergency use authorization for those 12 to 15.)

The question of whether booster shots are necessary has become the subject of intense debate and multiple studies since President Biden announced in August his plan to make booster shots available to adult recipients of the Pfizer-BioNTech and Moderna vaccines in September. The White House has already been forced to delay offering boosters to Moderna recipients, and for now, it is planning third shots only for those who received the Pfizer vaccine if the F.D.A. signs off. In its application to the F.D.A., Pfizer is asking for boosters to be given six months after the second dose, not eight months after, as Mr. Biden called for.

Dr. Janet Woodcock, the acting commissioner of the F.D.A., had hoped that booster shots could be offered this month not only for Pfizer and Moderna recipients, but for recipients of Johnson & Johnson’s one-dose vaccine as well, according to people familiar with the deliberations. But the administration had to limit its plan to Pfizer recipients, officials said, because neither Moderna nor Johnson & Johnson delivered the necessary data to the F.D.A. in time.

Moderna submitted an application for its booster dose to the F.D.A. earlier this month. A spokeswoman for the company said in an email on Thursday that she did not have an update on when a booster might be cleared.

Johnson & Johnson has not yet applied for booster clearance. A Johnson & Johnson spokesman said in an email on Thursday that the company planned to file for federal approval for the vaccine by the end of the year, but did not provide a timeline for when the company might submit a booster application.

Sharon LaFraniere and Noah Weiland contributed reporting.


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