This is the first coronavirus vaccine to seek regulatory OK in the United States.
The companies said in a statement that their vaccine candidate, known as BNT162b2, will potentially be available for use in high-risk populations in the US in mid to late December.
The submission to the FDA is based on results from the Phase 3 clinical trial of Pfizer’s vaccine, which started in the United States on July 27 and enrolled more than 43,000 volunteers.
The final analysis from the trial showed that the coronavirus vaccine was 95% effective in preventing infections, even in older adults, and did not cause any serious safety concerns, Pfizer and its German partner, BioNTech, announced this week. The submission also includes safety data for about 1
About 42% of global participants and 30% of U.S. participants in the Phase 3 survey have racially and ethnically diverse backgrounds, companies said in a press release, and 41% of global and 45% of U.S. participants are aged 56 to 85 years.
“Filing in the United States is a critical milestone in our journey to deliver a COVID-19 vaccine to the world, and we now have a more complete picture of both our vaccine’s efficacy and safety profile, giving us confidence in its potential,” Pfizer CEO Albert Bourla said in a statement.
Moderna, another pharmaceutical company, announced on Monday that the results of the early clinical trials show that the vaccine is 94.5% effective. The company plans to apply for FDA approval after it accumulates more safety data later this month.
Emergency use permit or EUA from the FDA is not the same as full approval. An EUA allows products to be used in special circumstances before all documentation is available for approval. For an EUA, the agency says it will determine whether a product’s “known and potential benefits outweigh its known and potential risks.”
What happens after an EUA
The FDA has scheduled a meeting of its advisory committee on vaccines and related biological products, a group of external experts, on Dec. 8, 9 and 10, a source familiar with the process tells CNN this week. The agency could make a decision at the end of the December 10 meeting on whether to issue an emergency use permit, the source said.
“It would make sense that the FDA would in all likelihood consider both applications together,” the source said, given that both Pfizer and Moderna vaccines use the same technology and appear to have very similar safety and efficacy results from their large-scale clinical. experiments.
If the FDA approves the vaccines, they can then be immediately distributed to states, according to a presentation made last month at the U.S. Centers for Disease Control and Prevention.
However, no one can be vaccinated until a CDC advisory committee reviews the data, recommends the vaccine, and decides which groups will receive it first.
If the FDA approves the vaccines, the CDC’s Advisory Committee on Immunization Practice, an independent panel of experts, will meet within 24 to 48 hours, according to a CDC spokesman.
At this meeting, the committee will decide whether everyone should get the vaccine or whether some people should be excluded.
“We have all been warned about ACIP, we need to be very flexible with our calendars because it will probably not be given very advanced notice for this meeting. It will be done very, very quickly,” Dr. William Schaffner, a committee member, told CNN this week.
Once ACIP has issued its recommendations, vaccinations may be given.
“We have a plan in place that the moment the FDA concludes that the vaccine is safe and effective, we have a system that should begin within 24 hours of sending it to hospitals and healthcare professionals and 24 hours after the vaccine is injected into Americans, ”said Vice President Mike Pence during a briefing by the Coronavirus Task Force at the White House on Thursday.
States are currently working out the details of running vaccination clinics. The Pfizer vaccine is particularly complicated as it must be stored at minus 75 degrees Celsius, and doctors’ offices and pharmacies typically do not have freezers that go that low.
The first groups expected to receive the vaccine are healthcare professionals, the elderly, important workers such as police officers and people with underlying medical conditions.
CNN’s Elizabeth Cohen contributed to this report.