J&J vaccine gets FDA EUA

Over the weekend, U.S. FDA issued an emergency use authorization for the third vaccine for the prevention of COVID-19, allowing Johnson & Johnson's Janssen vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

Over the weekend, U.S. FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of COVID-19, allowing Johnson & Johnson's Janssen vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

Unlike the Pfizer and Moderna vaccines, the Janssen COVID-19 vaccine is manufactured using an adenovirus type 26 (Ad26) to deliver a piece of the  genetic material used to make the distinctive “spike” protein of the SARS-CoV-2 virus. The vaccine leverages the company’s AdVac viral vector technology, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates.

Importantly, it's a single dose, and it doesn't require special storage. 

The available safety data to support the EUA include an analysis of 43,783 participants enrolled in an ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination.

J&J said last week that it was prepared to ship up to 4 million doses of the vaccine as soon as the EUA was given, 20 million by the end of March, and a total of 100 million doses by June.

Read the Janssen press release

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