J&J applies for emergency approval for COVID vaccines
February 5, 2021 – Johnson & Johnson’s world’s first single-dose COVID-19 vaccine has been submitted to the U.S. Food and Drug Administration for emergency approval.
Preliminary results from a large international study suggest the vaccine is not quite as potent as the two currently FDA-approved Pfizer and Moderna vaccines, which are two-dose vaccines, the Associated Press reported.
However, the J&J vaccine is easier to use and could reduce the shortage of COVID-19 vaccines.
An FDA advisory panel will review the new vaccine dates on Feb.26. The FDA will then decide if it should be approved.
FDA vaccine chief Dr. Peter Marks has warned against making comparisons between vaccines before all of the evidence has been gathered.
“Given the need to get this pandemic under control, I don’t think we can ignore any tool in the toolbox,” he told the American Medical Association last week, the AP reported. “We have to do our best to make sure we find the populations that will benefit most from each of these vaccines and use them thoughtfully.”
The J&J vaccine was 66% effective in preventing moderate to severe COVID-19 and 85% protected from the most serious symptoms. This yielded early results from the clinical study, which included 44,000 people in the US, Latin America and South Africa, AP reported.
And from 28 days after receiving the vaccine, no one who got it went to hospital or died.
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