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

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Johnson & Johnson has submitted its single-dose COVID-19 vaccine candidate for an emergency use authorization from the Food and Drug Administration.

“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. “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.”

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If the application is approved, it would be the third vaccine available for emergency use, following vaccines from Pfizer and BioNTech and Moderna.

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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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The announcement comes after Johnson & Johnson released data from the vaccine candidate’s Phase 3 clinical trial which showed 66 percent effectiveness overall against moderate to severe COVID-19 cases 28 days post-vaccination.

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

However, the efficacy of the vaccine varies from country to country. The level of protection against moderate to severe COVID-19 infection was 72 percent in the United States, 66 percent in Latin America and 57 percent 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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