The move sets the single-dose vaccine up for emergency use authorization by the Food and Drug Administration.
A FOOD AND DRUG Administration advisory committee on Friday unanimously endorsed Johnson & Johnson’s coronavirus vaccine candidate, likely setting it up for an imminent emergency use authorization from the agency.
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All members of the Vaccines and Related Biological Products Advisory Committee voted that the benefits of the single-dose vaccine outweigh the risks for individuals 18 years of age and older.
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If the agency follows the committee’s recommendation, which it typically does, and grants an emergency use authorization, the Biden administration said it is ready to deliver up to 4 million doses as soon as next week.
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The U.S. has purchased 100 million total doses of the vaccine, and Johnson & Johnson expects to have 20 million available by the end of March. Because it is a single-dose vaccine that only requires standard refrigeration, it will be much easier to deploy than other vaccine options.
The vaccine, which was developed by Johnson & Johnson’s vaccine arm Janssen Biotech, would be the third coronavirus vaccine approved by the agency. FDA staff released a brief earlier this week that found the vaccine has a “favorable safety profile.”
Clinical trials of the vaccine in the U.S. showed an efficacy of 72% in preventing moderate to severe disease after one month.
Over 70 million doses of the Pfizer and Moderna vaccines have been administered in the U.S., according to a tracker from the Centers for Disease Control and Prevention.
Vaccinations are “our path out” of the pandemic, CDC Director Rochelle Walensky said at a press briefing on Friday.
A Centers for Disease Control and Prevention advisory committee will meet over the weekend to vote on recommendations for the vaccine.
Cecelia Smith-Schoenwalder, Staff Writer
Cecelia Smith-Schoenwalder writes about space, science and the environment for U.S. News & … READ MORE
Tags: vaccines, coronavirus, Johnson & Johnson