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Janssen COVID-19 Vaccine Receives FDA Emergency Use Authorization

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eMediNexus    01 March 2021

The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) for the third COVID-19 vaccine, developed by Janssen, for the prevention of the disease. The vaccine can now be distributed in the U.S for use in individuals 18 years of age and above.

The available data clearly suggest that the Janssen COVID-19 vaccine may be effective in preventing COVID-19 and the known and potential benefits of the vaccine outweigh its known and potential risks. The vaccine is manufactured using the adenovirus type 26 (Ad26). This vaccine is given as a single dose and the safety data supporting the EUA come from an evaluation of 43,783 participants recruited in an ongoing randomized, placebo-controlled trial being done in South Africa, some countries in South America, Mexico, and the U.S… (FDA, February 27, 2021)

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