FDA authorizes Johnson & Johnson’s one-dose COVID vaccine, doses expected to start rolling next week

The U.S. Food and Drug Administration has authorized a third COVID-19 vaccine for public use.

As expected on Saturday, acting Commissioner Dr. Janet Woodcock granted an emergency use authorization for a vaccine developed by Janssen Pharmaceuticals, a Johnson & Johnson company.

About 4 million doses of the new vaccine should be made available next week, 20 million total during March, and another 80 million by the end of June. Because the vaccine requires only one dose, it will help protect 100 million people and take effect more rapidly than the two-dose vaccines.

The J&J vaccine joins two others, one from Pfizer-BioNTech and the other from Moderna, which have been given to nearly 50 million Americans since they were authorized in December.

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An FDA advisory committee voted Friday to support J&J’s vaccine, finding that its benefits far outweighed its risks.

Woodock agreed.

“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 in a statement. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

The Moderna and Pfizer-BioNTech vaccines appear to be more effective, showing better than 94% effectiveness in large trials they ran last year.

Although they can’t be compared directly, because the trials were conducted at different times, J&J’s vaccine appeared to be 72% effective among U.S. trial participants. It was less effective in South Africa and Latin America, where newer strains of the virus are circulating.

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The one-shot J&J vaccine also should be easier to distribute to rural areas and other places without pharmaceutical-grade freezers, because it can be stored for longer in a refrigerator.

And it may cause fewer side effects than the other two vaccines, with only about half of trial participants reporting injection site pain compared to nearly 80% for the Pfizer-BioNTech and Moderna vaccines, particularly with second shots.

An advisory committee to the Centers for Disease Control and Prevention will meet Sunday and Monday to discuss how the J&J vaccine should be used. Dr. Rochelle Walensky, the head of the CDC, will then review the vaccine, and it should be ready for distribution early next week.

Contact Karen Weintraub at kweintraub@usatoday.com

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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