It 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, would potentially be available for use in high-risk populations in the United States by mid to late December.
The FDA’s presentation 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 involved more than 43,000 volunteers.
The final analysis of the study found that the coronavirus vaccine is 95% effective in preventing infections, even in the elderly, and does not cause serious safety concerns, Pfizer and its German partner BioNTech announced this week. The presentation also includes safety data for about 1
About 42% of global participants and 30% of US participants in Phase 3 are of racial and ethnic diversity, the companies said in a news release, and 41% of global and 45% of US participants are between 56 and 85 years old.
“Submission to the United States is a critical milestone in our journey to deliver the COVID-19 vaccine around the world, and we now have a fuller picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.” Pfizer CEO Albert Burla said in a statement.
Moderna, another pharmaceutical company, announced on Monday that the results of early clinical trials show that its vaccine is 94.5% effective. The company plans to apply for an FDA approval after more safety data is collected later this month.
An emergency authorization or EUA from the FDA is not the same as full approval. The EUA allows products to be used in certain circumstances before all the evidence is available for approval. For the EUA, the agency says it will determine whether “the known and potential benefits of a product outweigh its known and potential risks”.
What happens after the EUA
The FDA has scheduled a meeting of its Advisory Committee on Vaccines and Related Organic Products, a group of outside experts, for Dec. 8, 9 and 10, a source familiar with the process told CNN this week. The agency could decide at the end of the meeting on December 10th whether to issue an emergency use permit, the source said.
“It would make sense for the FDA to 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 trials.
If the FDA approves the vaccines, they can be distributed immediately in the states, according to a presentation made last month at the US Centers for Disease Control and Prevention.
However, no one can be vaccinated until the CDC’s advisory committee has reviewed the data, recommended the vaccine and decided which groups will receive it first.
If the FDA approves the vaccines, the CDC’s Immunization Practices Advisory Committee, an independent group of experts, will meet within 24 to 48 hours, according to a CDC spokesman.
At this meeting, the committee will determine whether everyone should get the vaccine or some people should be excluded.
“We have all been warned by ACIP that we need to be very flexible with our calendars, because there will probably not be much advance notice of this meeting. This will be done very, very quickly, “said Dr. William Schaffner, a member of the commission, to CNN this week.
Once ACIP has issued its recommendations, vaccinations can be given.
“We have a plan in places that once the FDA concludes that this vaccine is safe and effective, we have a system that starts within 24 hours to send it to hospitals and health professionals and 24 hours later to injects this vaccine into Americans, “said Vice President Mike Pence during a White House Coronavirus Task Force briefing on Thursday.
Countries are currently developing details on working vaccination clinics. The Pfizer vaccine is particularly complex, as it must be stored at minus 75 degrees Celsius, and doctors and pharmacies usually do not have such low freezers.
The first groups expected to receive the vaccine are health workers, the elderly, key activities such as police officers and those with concomitant medical conditions.
CNN’s Elizabeth Cohen contributed to this report.