Coronavirus: Johnson & Johnson seeking vaccine candidate EUA

Johnson & Johnson has submitted an application to the Food and Drug Administration (FDA) seeking emergency use authorization (EUA) for the company’s single-shot Janssen COVID-19 coronavirus vaccine candidate.

According to a news release, the company intends to send doses to the federal government as soon as the EUA is granted and plans to supply 100 million doses of the vaccine in the first half of 2021.

"Today's submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic," Paul Stoffels, MD, vice chairman of the Executive Committee and chief scientific officer at Johnson & Johnson, says in the release. "Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. 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."

The New York Times reports that the FDA’s outside advisory panel plans to vote on the EUA application on Feb. 26.

Previously, Johnson & Johnson’s vaccine candidate was shown to be 66 percent effective overall in preventing moderate to severe. COVID-19 after 28 days with the onset of protection observed as early as 14 days after vaccination. As part of the multinational Phase 3 ENSEMBLE study, the candidate showed the level of protection was 72 percent in the U.S., 66 percent in Latin America, and 57 percent in. South Africa, according to a news release.

“Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic," Alex Gorsky, chairman of the board of directors and CEO of Johnson & Johnson, says in the release. "We're proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere."

The trial also showed the candidate was 85 percent effective in preventing severe disease across all regions 28 days after injection and the efficacy grew over time with no cases in vaccinated participants after 49 days, the release says.