This is the first coronavirus vaccine to get a regulatory fix in the United States.
Their vaccine candidate, known as BNT 162B2, will likely be available for use in high-risk people in the United States by the end of December, the companies said in a statement.
The submission to the FDA is based on the results of a Phase 3 clinical trial of the Pfizer vaccine, which began in the United States on July 27 and registered more than 43,000 volunteers.
The final analysis of the trial found that even in older adults, the coronavirus vaccine was 95% effective in preventing infection, and with no serious safety concerns, Pfizer and its German partner, Bioentek, announced this week. The submission includes safety data about 100 children between the ages of 12 and 15.
About 42% of global participants in the Phase 3 study and 30% of U.S. participants have racially and ethnically diverse backgrounds, the companies said in a news release, and 41% of global and U.S. Participants range in age from 56 to 85.
“Filing in the U.S. represents a critical milestone in our journey to deliver the COVID-19 vaccine to the world and we now have a more complete picture of both our vaccine effectiveness and safety profile, giving us confidence in its potential,” Borla said in a statement.
Another pharmaceutical company, Moderna, announced on Monday that preliminary clinical trial results showed its vaccine was 94.5..5% effective. The company plans to apply to the FDA for authorization after collecting more security data later this month.
Emergency use author authorization from the FDA, or EUA, is not the same as full approval. The EU allows products to be used in special circumstances before all evidence is available for approval. For the EU, the agency says it will determine whether the product’s “known and potential benefits outweigh its known and potential risks.”
What happens after the EU
The FDA has scheduled a meeting of its Vaccine and Related Biological Products Advisory Committee, a group of outside experts, for Dec. 8, 9 and 10, a source familiar with the process told CNN this week. The agency may decide at the end of its meeting on December 10 whether to allow the use of an emergency, the source said.
“It would make sense that in all likelihood the FDA would consider both applications together,” the source said, adding that both Pfizer and Moderna vaccines use similar technology and appear to have yielded similar safety and efficacy results from their larger-scale clinical. Tests.
If the FDA authorizes the vaccines, they can then be distributed to the states immediately, according to the U.S. Department of Disease Control and Prevention. According to a presentation made at the centers last month.
However, the CDC Advisory Committee will not review the data, recommend the vaccine, and decide which groups will receive it first.
If the FDA approves the vaccines, the CDC’s advisory committee, Immunization Practice, an independent panel of experts, will meet within 24 to 48 hours, a CDC spokesman said.
At that meeting, the committee will decide whether everyone should be vaccinated, or whether some people should be excluded.
“We have all been warned at ACIP that we should be very simple with our calendars, as not many advanced instructions will be given for this meeting. It will be done very quickly,” said Dr. William Schaffner, a. A member of the committee told CNN this week.
Once the ACIP releases its recommendations, the vaccine can be given.
“The FDA has vaccinated so that the vaccine is safe and effective. At the moment we have a plan that the vaccine can be started within 24 hours, sent to hospitals and healthcare officials, and vaccinated after 24 hours. Pence said during a White House coronavirus task force briefing on Thursday.
States are currently working on details of running vaccination clinics. The Pfizer vaccine is particularly complex, as it must be stored at minus 75 degrees Celsius, and doctors’ offices do not usually have freezers that come low.
The first groups to expect to receive the vaccine include essential functions such as health care workers, the elderly, police personnel, and underlying medical conditions.
Elizabeth Cohen of CNN contributed to this report.
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