Johnson & Johnson Requests Emergency Authorization of Its Single Shot Vaccine, Says It Can Ship Immediately

Johnson and Johnson
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Johnson & Johnson announced last night that it had submitted an application to the U.S. Food and Drug Administration for an emergency use authorization for its single-dose COVID-19 vaccine candidate.

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Last week, the company released data showing that its vaccine candidate is 66% effective overall at preventing moderate to severe COVID cases. In the statement last night, the company said it expected to have the products available to ship “immediately following authorization.”

If approved, it would be the third vaccine in the U.S. and the first one requiring only one dose, facilitating and accelerating distribution amid a rollout that has been less than seamless.

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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, M.D., vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, said in a statement. “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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The Johnson & Johnson vaccine would be relatively easy to store, as this single-dose vaccine is estimated to remain stable for two years at minus-4 degrees Fahrenheit (minus-20 degrees Celsius), at least three months of which can be stored in most standard refrigerators at temperatures of 36 degrees Fahrenheit to 46 degrees Fahrenheit (2 degrees Celsius to 8 degrees Celsius). “The company will ship the vaccine using the same cold chain technologies it uses today to transport other innovative medicines,” according to the statement.  Moderna’s COVID vaccine has to be stored in a freezer at between  minus-13 degrees Fahrenheit and 5 degrees Fahrenheit (minus-25 degrees Celsius and minus-15 degrees Celsius), according to the Centers for Disease Control, adding that “these temperatures are within the appropriate range for routinely recommended vaccines but the temperature range for this vaccine is tighter.”

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Meanwhile, Pfizer’s vaccine has to be stored in an ultra-cold freezer at between minus-112 degrees Fahrenheit and minus-76 degrees Fahrenheit (minus-80 degrees Celsius and minus-60 degrees Celsius), the CDC says.

Last week, Johnson & Johnson announced its fourth-quarter and full-year 2020 results beating analysts’ expectations.

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About the Author

Yaël Bizouati-Kennedy is a former full-time financial journalist and has written for several publications, including Dow Jones, The Financial Times Group, Bloomberg and Business Insider. She also worked as a vice president/senior content writer for major NYC-based financial companies, including New York Life and MSCI. Yaël is now freelancing and most recently, she co-authored  the book “Blockchain for Medical Research: Accelerating Trust in Healthcare,” with Dr. Sean Manion. (CRC Press, April 2020) She holds two master’s degrees, including one in Journalism from New York University and one in Russian Studies from Université Toulouse-Jean Jaurès, France.

Johnson & Johnson Requests Emergency Authorization of Its Single Shot Vaccine, Says It Can Ship Immediately
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