FDA: Johnson & Johnson’s Single-Dose COVID Vaccine Safe, Effective

Clinical Trial - Vaccine: Covid-19, Coronavirus in vial with syringe on white background.
Bill Oxford / Getty Images/iStockphoto

The U.S. Food and Drug Administration said today that Johnson & Johnson’ s COVID vaccine candidate has a “favorable safety profile,” which brings the vaccine a step closer to being granted emergency use approval by the agency.

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The FDA is meeting Friday to determine whether it will authorize Johnson & Johnson’s vaccine, according to an FDA report released today. Authorization would make it the third vaccine in the U.S.

The company had submitted an application for an emergency use authorization for its single-dose COVID-19 vaccine candidate earlier this month. Data the company released at that time showed that its vaccine candidate is 66% effective overall at preventing moderate to severe COVID cases. In that statement, Johnson & Johnson said it expected to have the products available to ship “immediately following authorization.”

“The analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA [emergency use authorization],” the FDA said in its new report.

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The report explains that as the COVID-19 pandemic constitutes a public health emergency “with a significant potential to affect national security or the health and security of United States citizens living abroad,” it may issue an EUA after determining that certain statutory requirements are met.

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If approved, Johnson & Johnson’s candidate would be the first vaccine requiring only one dose, facilitating and accelerating distribution amid a rollout that has been less than seamless.

In addition, 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 earlier statement.

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In comparison, 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.”

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.

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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.
FDA: Johnson & Johnson’s Single-Dose COVID Vaccine Safe, Effective
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