Johnson & Johnson submits single-dose COVID-19 vaccine candidate to the FDA for emergency use authorization

Johnson & Johnson submitted its single-dose vaccine candidate COVID-19 for emergency use authorization to the Food and Drug Administration on Thursday, calling it a “key step” in “ending the pandemic.”

The pharmaceutical giant’s move comes after data released last week showing it was about 72% effective in protecting against the virus in the United States. If approved, it would be the third vaccine authorized in the United States, after Pfizer-BioNTech and Moderna, which received authorization in December.

“Today’s submission for the Emergency Use Authorization for our experimental single-dose COVID-19 vaccine is a key step in reducing the burden of disease for people around the world and ending the pandemic,” said the scientific director. and Johnson & Johnson vice president Paul Stoffels, MD, said in a statement on Thursday.

Once authorized, the vaccine is “ready to start shipping,” said Stoffels, adding that the company, in conjunction with health officials around the world, “is working with great urgency to make our experimental vaccine available to the public. as soon as possible”.

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Johnson & Johnson said earlier that it expects to deliver 100 million doses to the United States by June.

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If authorized, the vaccine is estimated to remain stable for two years at -4 degrees Fahrenheit, or -20 degrees Celsius, and in most standard refrigerators at temperatures from 36 to 46 degrees Fahrenheit for at least three months.

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This December 2, 2020 photo provided by Johnson & Johnson shows vials of the Janssen COVID-19 vaccine in the United States. On Thursday, February 4, 2021, Johnson & Johnson asked U.S. regulators to release the world’s first single-dose COVID-19 vac

The effectiveness of the J&J vaccine varies from country to country. Although it was 72% effective internally, the number has dropped to 66% in Latin America and 57% in South Africa, where a new highly contagious strain called B.1.351 is spreading rapidly.

The first cases of variant B.1.351 in the United States were identified in South Carolina earlier this month.

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Janssen, the company’s pharmaceutical subsidiary, plans to distribute doses of vaccines to the federal government immediately after FDA authorization, and expects to supply 100 million doses in the United States during the first half of 2021.

The Department of Health and Human Services announced in August that it had reached an agreement with Janssen to buy 100 million doses for $ 1 billion. The deal gives the government the option to buy 200 million additional doses.

The US Centers for Disease Control and Prevention reported on Thursday that more than 35.2 million doses of vaccine have been administered so far. According to Johns Hopkins University, the coronavirus has infected more than 26.6 million Americans and has killed more than 455,000 Americans since the pandemic began.

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