FDA Unanimously Recommends Johnson & Johnson Emergency Use Authorization

Mandatory Credit: Photo by Dania Maxwell/Los Angeles Times/Shutterstock (11759695k)Evelin Nunez, left, gives Concepcion Ponez the Pfizer vaccine during an event to inoculate about 500 health care workers and adults over the age of 65 against COVID-19 put on by the Labor Community Services, the Los Angeles Federation of Labor and St.
Dania Maxwell/Los Angeles Times/Shutterstock / Dania Maxwell/Los Angeles Times/Shutterstock

The Food and Drug Administration Vaccines and Related Biological Products Advisory Committee recommended the emergency use authorization of Johnson & Johnson’s single shot COVID vaccine candidate during an all-day meeting yesterday.

See: FDA – Johnson & Johnson’s Single-Dose COVID Vaccine Safe, Effective
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Johnson & Johnson’s candidate, the Janssen Biotech Inc. COVID-19 Vaccine, will be the third vaccine being granted an EUA and the first one requiring only one dose, facilitating and accelerating distribution amid a rollout that has been less than seamless.

The company 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.”

Earlier this week, the FDA said that Johnson & Johnson’ s COVID vaccine candidate has a “favorable safety profile.” The analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA,” the FDA said in its report released Wednesday.

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According to the FDA advisory committee’s supporting documents, the vaccine offers “substantial protection, especially against severe COVID-19 including hospitalization and death, irrespective of variant.”

The vaccine’s single, 0.5ml dose, with five doses per vial, also offers the ability to vaccinate the population faster, according to the FDA committee documents.

In addition, it would be relatively easy to store compared to the other two vaccines, as it can be stored for 3 months at normal refrigerator temperatures of 36 degrees Fahrenheit to 46 degrees Fahrenheit (2 degrees Celsius to 8 degrees Celsius) and has a two-year shelf life when frozen at minus-13 degrees Fahrenheit to 5 degrees Fahrenheit (minus-25 degrees Celsius to minus-15 degrees Celsius), according to the documents.

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“The company will ship the vaccine using the same cold chain technologies it uses today to transport other innovative medicines,” according to an earlier Johnson & Johnson statement.

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. 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.

The committee said today it expects “to supply 100 million doses to the U.S. in the first half of 2021,” and that “shipping fits into existing supply chain infrastructure,” according to the documents.

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Jeff Zients, White House coronavirus response coordinator, said in a briefing Wednesday that he had updated and reviewed with the nation’s governors the plans to distribute the Johnson & Johnson vaccine if the EUA is granted, according to a statement.

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“The governors are carefully planning their efforts and getting ready for the possible new vaccine. If authorized, we are ready to roll out this vaccine without delay. Our distribution approach will mirror the current allocations process across jurisdictions, pharmacies and community health centers,” he said.

“If an EUA is issued, we anticipate allocating three to four million doses of Johnson & Johnson vaccine next week. Johnson & Johnson has announced it aims to deliver a total of 20 million doses by the end of March. We’re working with the company to accelerate the pace and timeframe by which they deliver the full 100 million doses, which is required by contract by the end of June,” Zients said.

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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.

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