J&J COVID vaccine heads to FDA for emergency use decision
Late yesterday Johnson & Johnson submitted a request for an emergency use authorization (EUA) for its COVID-19 candidate. If the EUA is granted by the Food and Drug Administration (FDA), the vaccine will become the third COVID-19 vaccine approved for use in the United States, and the first that requires only one dose.
Last week Johnson & Johnson released results from a phase 3 trial of the drug that showed an overall efficacy rate of 66%. The vaccine, however, was more than 85% effective in preventing severe illness from COVID-19 infections and 100% effective in preventing hospitalizations and deaths.
“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” said Paul Stoffels, MD, the chief scientific officer for Johnson & Johnson in a press statement.
“With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”
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If approved, the vaccine may be ready for use in the United States by the end of March. Through Operation Warp Speed, Johnson & Johnson has a contract to fulfill 100 million doses of vaccine in the coming year. Last year, the FDA said it would likely approve any vaccine that proved to be more than 50% effective against the novel coronavirus.