Johnson & Johnson seeks emergency authorization from FDA for COVID-19 vaccine

Johnson & Johnson applied for an emergency use authorization from the U.S. Food and Drug Administration for its one-shot COVID-19 vaccine.

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“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, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson. “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.”

If Johnson & Johnson’s application is approved, it would be the third COVID-19 vaccine authorized for emergency use in the United States. Vaccines developed by Pfizer-BioNTech and Moderna have already been approved. Pfizer’s vaccine was authorized by the FDA on Dec. 11, and Moderna’s was authorized a week later, CNBC reported.

The Johnson & Johnson vaccine is 66% effective broadly against moderate to severe infection, but provides strong protection against hospitalization and death, Politico reported, citing a global study.

Dr. Anthony Fauci, the nation’s leading infectious disease expert, said the most important finding of the Johnson & Johnson data was the vaccine appeared to be 85% effective in preventing severe disease, CNBC reported.

“The most important thing, more important than whether you prevent someone from getting aches and a sore throat, is preventing people” from getting severe disease, Fauci told reporters on Jan. 29. “That will alleviate so much of the stress and human suffering and death in this epidemic.”

The company initiated rolling submissions with several health agencies outside the United States and will submit a conditional marketing authorization application (cMAA) with the European Medicines Agency in the coming weeks.

The FDA is asking its independent advisers to publicly debate all the data behind the single-dose shot before approving it, according to The Associated Press.

Peter Marks, the FDA’s vaccine chief, cautioned against making comparisons before the evidence is all in regarding the Johnson & Johnson vaccine, the AP reported.

“With so much need to get this pandemic under control, I think we can’t ignore any tool in the tool chest,” Marks told the American Medical Association last week. “We will have to do our best to try to make sure that we find the populations that benefit the most from each of these vaccines and deploy them in a very thoughtful manner.”

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