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

Johnson & Johnson vaccine trial data looks really good: Infectious disease expert

Infectious disease expert Dr. Amesh Adalja argues the J&J vaccine is ‘logistically’ much easier to give and there could be emergency use authorization by the end of January 2021.

Johnson & Johnson submitted its single-dose COVID-19 vaccine candidate for emergency use authorization to the Food and Drug Administration on Thursday calling it a "pivotal step forward" to "putting an end to the pandemic."

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

“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,” Johnson & Johnson chief scientific officer and vice-chairman Paul Stoffels, M.D., said in a statement Thursday.

Once authorized, the vaccine is "ready to begin shipping," stated Stoffels who added that the company in conjunction with health authorities around the world "are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”

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Johnson & Johnson has previously said it expects to supply 100 million doses to the U.S. 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 of 36 to 46 degrees Fahrenheit for at least three months.

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

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

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

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Janssen, the company's pharmaceutical subsidiary, intends to distribute vaccine doses to the federal government immediately following authorization from the FDA, 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 purchase 100 million doses for $1 billion. The agreement gives the government the option to purchase an additional 200 million doses.

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

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