The U.S. Food and Drug Administration on Saturday granted emergency-use authorization of Johnson & Johnson’s one-dose coronavirus vaccine.
The decision comes a day after the FDA’s Vaccines and Related Biological Products Advisory Committee recommended the vaccine by a 22-0 vote.
The vaccine becomes the United States’ third against COVID-19, but the only one that provides enough protection with a single dose, The Washington Post reported. Experts said it could expedite efforts to inoculate the population as virus variants spread, the newspaper reported.
“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,” acting FDA Commissioner Janet 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 Johnson & Johnson vaccine does not have to be kept frozen and there is no need for a second round of appointments, the Post reported. That makes it an advantageous vaccine for rural areas and other hard-to-reach communities, and for distribution to community health centers and physician offices that might not have the freezers needed for the other vaccines, the newspaper reported.
Johnson & Johnson officials have pledged to provide the United States with 100 million doses by the end of June, The New York Times reported. That will be combined the 600 million doses from the two-shot vaccines made by Pfizer-BioNTech and Moderna that are scheduled to arrive by the end of July, thew newspaper reported. That should be more than enough shots to cover any U.S. adult who wants a vaccine, according to the Times.
Under an emergency use authorization, the FDA has the authority to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions during a declared public health emergency.
“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.”
Coronavirus vaccines made by Pfizer and Moderna have already been approved for emergency use in the U.S. Unlike Johnson & Johnson’s shot, those vaccines require two doses each but are reported to be about 95% effective, the AP reported.
Friday’s advisory meeting came two days after the committee said in briefing documents that Johnson & Johnson’s coronavirus vaccine has a “favorable safety profile with no specific safety concerns.”
Johnson & Johnson’s Janssen Pharmaceuticals unit applied to the FDA for emergency use authorization for the vaccine on Feb. 4, submitting clinical trial data involving 44,000 participants in eight countries. On Wednesday, the agency released its analysis that the vaccine was safe and effective. On Friday, the agency’s outside vaccine advisers voted unanimously to recommend authorization.
An analysis of data from a Phase 3 clinical trial found that Johnson & Johnson’s vaccine is about 66% effective overall at preventing moderate to severe cases of COVID-19, according to The Associated Press. Johnson & Johnson previously announced that its vaccine had a higher efficacy of 72% among U.S. participants, compared with 66% in Latin America and 57% in South Africa.
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