The Slatest

FDA Grants Emergency Authorization for Johnson & Johnson’s One-Shot COVID Vaccine

Empty vials that contained a dose of the Johnson & Johnson vaccine against the COVID-19 coronavirus lie on a table as South Africa proceeds with its inoculation campaign at the Klerksdorp Hospital on February 18, 2021.
Empty vials that contained a dose of the Johnson & Johnson vaccine against the COVID-19 coronavirus lie on a table as South Africa proceeds with its inoculation campaign at the Klerksdorp Hospital on February 18, 2021. PHILL MAGAKOE/Getty Images

There is now a third COVID-19 vaccine authorized for use in the United States. The Food and Drug Administration gave the all-clear for Johnson & Johnson’s vaccine for emergency use. This vaccine stands apart from the others because it is the first that has been authorized that requires only one shot. Acting Commissioner Dr. Janet Woodcock granted the emergency use authorization for the vaccine developed by Janssen Pharmaceuticals, a Johnson & Johnson company. “The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” Woodcock said.

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The approval was widely expected after the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted to recommend authorizing the vaccine on Friday. The vaccine was tested globally and found to be 66.1 percent effective against moderate to severe COVID-19 four weeks after vaccination. Specifically in the United States it was found to be 72 percent effective while providing 86 percent protection against severe COVID-19 and none of the participants in the clinical trials died of the virus. Although the vaccine does provide protection against the new variants, it was shown to be less effective in South Africa and Latin America, where the new strains of the virus are circulating more heavily.

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The new vaccine won’t immediately boost the numbers of available shots for Americans by that much. The company has said it has less than 4 million doses ready to ship immediately. By the end of March, the company expects to be able to delivery around 20 million doses with a total of 100 million expected in the first half of the year.

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This latest vaccine can be stored longer than the others in a refrigerator, meaning it could be a game-changer for access because it is easier to distribute to rural areas where it isn’t easy to come by pharmaceutical-grade freezers. That isn’t the only thing that sets this vaccine apart from the Moderna and Pfizer vaccines that are already being used in the United States. While the Moderna and Pfizer vaccines use new messenger RNA technology the Johnson & Johnson vaccine uses viral vector technology. The vaccine involves a genetically engineered common cold virus called adenovirus 26.

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The different efficacy rates have led some to see the Johnson & Johnson vaccine as less desirable than the other two but experts say that isn’t the case. On Sunday, Dr. Anthony Fauci said Americans should take any of the three vaccines. “These are three highly efficacious vaccines. I can tell you I have been fully vaccinated with one that was available. It was the Moderna,” he told CNN. “If I were not vaccinated now and I had a choice of getting a J&J vaccine now or waiting for another vaccine, I would take whatever vaccine would be available to me as quickly as possible for the simple reason of what I said a moment ago, we want to get as many people vaccinated as quickly and expeditiously as possible.” Fauci cautioned against comparing efficacy rates between different vaccines. “We’ve got to get away from that chain of thought,” Fauci said on ABC. “The only way you really know the difference between vaccines is by comparing them head-to-head. We have three highly efficacious vaccines that are safe and efficacious. That’s the bottom line.”

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