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J&J Seeks Emergency Approval of Single-Dose COVID-19 Vaccine

FRIDAY, Feb. 5, 2021 (HealthDay News) — The world’s first single-dose COVID-19 vaccine, from Johnson & Johnson, has been submitted to the U.S. Food and Drug Administration for emergency use approval.

Preliminary findings from a large international study suggest the vaccine isn’t quite as strong as the two current FDA-approved vaccines from Pfizer and Moderna, which are two-dose vaccines, the Associated Press reported.

However, the J&J vaccine is easier to use and could ease COVID-19 vaccine shortages.

An FDA advisory panel will review data on the new vaccine on Feb. 26. The FDA will then decide whether to approve it.

FDA Vaccine Chief Dr. Peter Marks has cautioned against making comparisons between vaccines before all of the evidence is collected.

“With so much need to get this pandemic under control, I think we can’t ignore any tool in the tool chest,” he told the American Medical Association last week, the AP reported. “We will have to do our best to try to make sure that we find the populations that benefit the most from each of these vaccines and deploy them in a very thoughtful manner.”

The J&J vaccine was 66% effective at preventing moderate to severe COVID-19, and 85% protective against the most serious symptoms, according to early results of the clinical trial that included 44,000 people in the United States, Latin America and South Africa, the AP reported.

And starting 28 days after receiving the vaccine, no one who got it required hospitalization or died.

Copyright © 2020 HealthDay. All rights reserved.

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