J&J Single-Dose Covid-19 Vaccine Gets Review From FDA Advisory Panel

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An all-day meeting, which will provide the FDA with the perspective of outside experts, is the last step before the agency decides whether to authorize the single-dose J&J Covid-19 vaccine

A committee of independent medical experts convenes Friday to review Johnson & Johnson ’s Covid-19 single-dose vaccine, the final step before U.S. health regulators decide whether to authorize use of a third shot.

The panel, which includes 22 medical specialists in fields like internal medicine, pediatrics, vaccines and epidemiology, regularly advises the U.S. Food and Drug Administration about experimental vaccines. It voted to recommend shots from Pfizer Inc. and Moderna Inc.If the panel votes to endorse the J&J shot, the agency is expected to permit the product’s wide use as soon as Saturday.

During the all-day public meeting, representatives from the FDA and J&J will discuss the safety and effectiveness of the company’s vaccine in a 44,000-plus subject study, according to an agenda. The vaccine was 66% effective at protecting people from moderate to severe Covid-19, an FDA review found, and even more effective at preventing severe disease alone.

 

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