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Friday, April 9th, 2021

FDA advisory committee expected to recommend Johnson & Johnson COVID-19 vaccine for emergency use in United States

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The Food and Drug Administration (FDA) is holding an advisory committee meeting on Friday during which the committee is expected to recommend a single-dose Johnson & Johnson (J&J)-Janssen Biotech SARS-CoV-2  vaccine to become the third COVID-19 vaccine available for emergency use to millions of Americans.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will spend the entire day discussing whether to recommend the J&J COVID-19 shot for use in adults. The results of a Phase Three trial earlier this month concluded the vaccine offered an overall efficacy of 66 percent in preventing moderate cases, 85 percent in preventing severe cases, and 100 percent in preventing hospitalization.

This did vary by region, though. In the United States, the vaccine was found to be 72 percent effective for all ethnic, racial, and age groups. Results in South Africa and Latin America, where COVID-19 variants have taken root, were much lower.

If approved, the vaccine could go a long way to increasing supply at a time when President Joe Biden has committed to ever-higher doses. Unlike the Pfizer-BioNTech and Moderna vaccines, the J&J vaccine requires only one dose instead of  two. It can also be refrigerated for three months, rather than frozen, making it easier to distribute and store. If frozen, it can last for up to two years.

Notably, this panel is only making a recommendation for emergency use authorization. It still requires approval from the FDA’s acting commissioner. Still, its recommendation is likely, as the vaccine has largely met all the criteria for authorization already established by the FDA, and J&J has proven it can manufacture the vaccine consistently.

J&J has pledged to provide 100 million doses of the vaccine by June if approved and to reach a milestone of 20 million by the end of March. This will be on top of the 600 million total doses already being delivered by Pfizer-BioNTech and Moderna by the end of July.

VRBPAC members will pore over all available data on the vaccine before making their decision, addressing FDA requirements, clinical study results, J&J’s plans, and the benefits and risks associated. Based on the scientific evidence, it will then vote on the recommendation.