Both Moderna and Johnson & Johnson have submitted requests for emergency use authorization of their booster shots of the COVID vaccines, but when could federal regulators make a decision?
The FDA is convening its outside panel of advisers next week to review booster data from both J&J and Moderna. It’s the first step in a review process that also includes sign-off from the leadership of both the FDA and the Centers for Disease Control and Prevention. If both agencies give the go-ahead, Americans could begin getting J&J and Moderna boosters later this month.
Last month, the FDA authorized booster shots of Pfizer’s vaccine for older Americans and other groups with heightened vulnerability to COVID-19, but that authorization did not apply to J&J and Moderna recipients. Boosters of the Moderna vaccine for immunocompromised individuals have been authorized, but that also did not apply to the J&J vaccine.
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U.S. officials don't recommend mixing and matching different vaccine brands.
Johnson & Johnson asked the FDA on Tuesday to allow extra shots of its COVID-19 vaccine as the U.S. government moves toward expanding its booster campaign to millions more vaccinated Americans.
The timing of the J&J filing was unusual given that the FDA had already scheduled its meeting on the company's data. Companies normally submit their requests well in advance of meeting announcements. A J&J executive said the company has been working with FDA on the review.
J&J previously released data suggesting its vaccine remains highly effective against COVID-19 at least five months after vaccination, demonstrating 81% effectiveness against hospitalizations in the U.S.
But company research shows a booster dose at either two or six months revved up immunity even further. Data released last month showed giving a booster at two months provided 94% protection against moderate-to-severe COVID-19 infection. The company has not yet released clinical data on a six-month booster shot.
FDA's advisers will review studies from the company and other researchers next Friday and vote on whether to recommend boosters.
“Both J&J and FDA have a sense of urgency because it’s COVID and we want good data out there converted into action as soon as possible,” said Dr. Mathai Mammen, head of research for J&J's Janssen unit.
Bloomberg, citing people familiar with the matter, reported last week that the FDA was leaning toward authorizing half-dose booster shots for those who received Moderna's two-shot mRNA vaccine.
Moderna submitted data to the FDA seeking evaluation for its booster shot on Sept. 1.
“We are pleased to initiate the submission process for our booster candidate at the 50 µg dose with the FDA. Our submission is supported by data generated with the 50 µg dose of our COVID-19 vaccine, which shows robust antibody responses against the Delta variant,” Stéphane Bancel, Moderna's CEO, said in a statement.
Moderna previously released data on breakthrough cases, saying it supports the push for wide use of COVID-19 vaccine booster shots.