US Closer to Having a Third Vaccine Option

Johnson & Johnson asks FDA to OK its one-shot COVID-19 vaccine
By Newser Editors and Wire Services
Posted Feb 5, 2021 12:05 AM CST
Johnson & Johnson Asks US to Clear Its Vaccine for Use
This Dec. 2, 2020 photo provided by Johnson & Johnson shows vials of the Janssen COVID-19 vaccine in the United States.   (Johnson & Johnson via AP)

Johnson & Johnson asked US regulators Thursday to clear the world’s first single-dose COVID-19 vaccine, an easier-to-use option that could boost scarce supplies, the AP reports. J&J’s vaccine was safe and offered strong protection against moderate to severe COVID-19, according to preliminary results from a massive international study. It didn’t appear quite as strong as two-dose competitors made by Pfizer and Moderna—a finding that may be more perception than reality, given differences in how each was tested. But the FDA is asking its independent advisers to publicly debate all the data behind the single-dose shot—just like its competitors were put under the microscope—before it decides whether to green light a third vaccine option in the US. The panel will meet Feb. 26. NBC News reports the agency is expected to greenlight the vaccine.

Overall, the single-dose vaccine was 66% effective at preventing moderate to severe COVID-19, according to early findings from a study of 44,000 people in the US, Latin America, and South Africa. But it was 85% protective against the most serious symptoms—and starting 28 days after their shot, researchers found no one who got the vaccine needed hospitalization or died. The one-dose option worked better in the US—72% effective against moderate to severe COVID-19—compared with 66% in Latin America and 57% in South Africa, where a more contagious mutant virus is spreading. Scientists have been looking for real-world evidence about how vaccines work as the world races to stay ahead of the rapidly mutating virus, and welcomed the news that the J&J option—while weaker—did still offer protection. Testing of the Pfizer and Moderna vaccines was completed before the record virus surges of recent months and the appearance of the worrisome mutants, meaning such testing might not turn out the same if repeated today.

(More coronavirus vaccine stories.)

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