FDA says Johnson & Johnson vaccine meets requirements for authorization

FDA says Johnson & Johnson vaccine meets requirements for authorization

An FDA advisory committee is set to discuss the vaccine in a Friday hearing.

February 24, 2021, 1:58 PM

• 2 min read

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Johnson & Johnson and the FDA on Wednesday released respective detailed analysis on the one-shot COVID-19 vaccine, with the FDA announcing the company's data meets the requirements for the emergency use authorization review process.

The vaccine won't be authorized until Friday or later. First, there will be a public hearing Friday, in which the FDA's independent advisory committee will give an authorization recommendation for or against. The FDA could then make its decision as early as Friday evening.

If authorized, J&J expects it could have 20 million doses by March, and 100 million doses by the end of June.

Empty vials that contained a dose of the Johnson & Johnson vaccine against the COVID-19 coronavirus at the Klerksdorp Hospital on Feb. 18, 2021.

The data released Wednesday is a more detailed version of what the company previously outlined in a press release.

Importantly, the data released shows the vaccine works against all variants. The vaccine was less effective at preventing symptomatic illness in South Africa, where the variant first detected there is dominant, but it was still highly effective at preventing severe disease there.

J&J also released preliminary data indicating the vaccine likely helps prevent asymptomatic infections, and that the Brazil variant doesn't appear to have as much of an impact on vaccine efficacy as the South African variant

This is a developing story. Please check back for updates.

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