Where do Moderna and Johnson & Johnson stand on full FDA approval?


RALEIGH, N.C. (WNCN) – While the FDA approval of the Pfizer COVID-19 vaccine is welcome news for public health officials hoping it boosts vaccine uptake, it’s just one of the three COVID-19 vaccines in the U.S. So far, Moderna and Johnson & Johnson are still under Emergency Use Authorization.

Back in June, Moderna announced it would start “rolling submission” of data to the FDA for approval over the coming weeks. Moderna said it would request a Priority Review. This designation would call for the FDA to make a decision within six months rather than the typical 10-month waiting period.

Pfizer started that process in May and the FDA made a decision four months later. It means Moderna’s full FDA approval could come as early as next month.

Johnson & Johnson has not started the approval process yet. In February, when its vaccines first came out, the company said it would file for full approval later in 2021 but did not lay out a specific timeline. For full approval, the FDA wanted to see at least six months’ worth of safety data for all the vaccines. It means Johnson and Johnson recipients may still have to wait a few months to get their full approval.

While Pfizer got full approval for its two-dose series of the COVID-19 vaccine, the approval does not cover third doses for the immunocompromised, boosters for the general public, or vaccines in children under 16. Those three are still authorized for emergency use. Pfizer must apply for FDA approval for those specific uses.

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