Pfizer, BioNTech submit emergency authorization request to FDA Friday for COVID-19 vaccine

A final analysis of the phase 3 trial shows the drug is more than 95% effective.

November 20, 2020, 7:30 AM

Pfizer and partner BioNTech announced they have submitted a request on Friday to the U.S. Food and Drug Administration for emergency use authorization of their COVID-19 vaccine candidate.

"It is with great pride and joy, and even a little relief, but I can say that our request for emergency use authorization for our COVID-19 vaccine is now in the FDA's hands," Dr. Albert Bourla, chairman and CEO of Pfizer, said in a video statement Friday afternoon. "This is a historic day, a historic day for science and for all of us. It took just 248 days to get from the day we announced our plans to collaborate with BioNTech to our FDA submission day."

"Today we were able to submit a very robust data set, that we believe meets and in many cases exceeds the FDA's high standards," he added.

Late Friday, the FDA said it has set a date of Dec. 10 to meet with Pfizer and BioNTech representatives about authorization. It will be a public meeting, and a chance for both FDA career scientists and members of the independent advisory board to ask Pfizer questions about its product. After that, the board will make a recommendation.

FDA will take that recommendation into account when it decides whether to authorize the vaccine.

Bourla said the companies have already initiated rolling submissions with several drug regulatory agencies around the world, including in Australia, Canada, Europe, Japan and the United Kingdom, and "we plan to submit immediately to other regulatory authorities around the world."

The submission, which is based on a vaccine efficacy rate of 95% demonstrated in the phase 3 clinical study with no serious safety concerns to date, will potentially enable the use of the drug in high-risk populations in the United States by the middle to end of December, according to a joint press release.

"Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally," Bourla said in a statement Friday prior to completing the official request. "Filing in the U.S. represents 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 the efficacy and safety profile of our vaccine, giving us confidence in its potential."

The companies said they will be ready to distribute the vaccine within hours after authorization.

A file photo provided by the University of Maryland School of Medicine, shows the first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore.
Courtesy of University of Maryland School of Medicine via AP, FILE

Based on current projects, the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021, according to the press release.

"Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible," Dr. Ugur Sahin, CEO and co-founder of BioNTech, said in a statement Friday. "We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process."

The FDA requires at least two months of safety data among at least half of the trial volunteers before it will consider granting a limited emergency authorization.

Pfizer, a New York City-based pharmaceutical company, and BioNTech, a German biotechnology firm, announced earlier this week that their COVID-19 vaccine candidate, called BNT162b2, is more than 95% effective in the final analysis of their massive Phase 3 trial and has reached a key safety milestone that will allow them to apply for the FDA authorization "within days."

Syringes are seen in front of the displayed logos of BioNTech and Pfizer in this illustration taken on Nov. 10, 2020.
Dado Ruvic/Reuters

Among the 170 volunteers to develop COVID-19 in the clinical trial, 162 had been given placebo shots while only eight volunteers to become infected were administered the real vaccine. Pfizer and BioNTech didn't record any serious safety concerns in the clinical trial. Like most vaccines, BNT162b2 -- which is administered in two doses over the course of three weeks -- caused mild side effects. The most common "grade 3" adverse effects were fatigue, which happened in about 3.7% of volunteers, and headache, in 2%, according to a joint press release issued Wednesday.

Just last week, Pfizer and BioNTech announced that BNT162b2 was more than 90% effective according to a preliminary analysis based on the first 94 patients to develop symptomatic COVID-19 in a trial of more than 43,000 volunteers.

The updated efficacy data follows news from competitor Moderna, which announced Monday that its vaccine candidate was 94.5% effective in its own preliminary analysis.

Once the FDA receives the application for emergency use authorization, it will review the data and convene a panel of outside experts to offer an opinion about whether the vaccine should be approved. Then, the agency will make its final decision.

If the FDA gives the Pfizer/BioNTech vaccine the green light, the companies will likely make history as the first with an FDA-authorized COVID-19 vaccine. The limited authorization would come as the United States reports record-high numbers of COVID-19 cases, deaths and hospitalizations.

ABC News' Sony Salzman and Teri Whitcraft contributed to this report.