Pfizer and BioNTech have applied today for emergency use authorization (EUA) of their COVID-19 vaccine candidate BNT162b2, with the first doses set to reach people at high risk of the virus as soon as next month.
The companies said they supported their EUA application in part with final efficacy data they announced earlier this week showing BNT162b2 to be 95% effective in their nearly 44,000-patient Phase III trial (NCT04368728) of the vaccine in participants without prior SARS-CoV-2 infection.
In addition, BioNTech and Pfizer said, they supported their EUA application with positive safety data. The companies will combine solicited safety data from a randomized subset of approximately 8,000 participants ≥18 years of age, with unsolicited safety data from approximately 38,000 trial participants who were followed for a median of two months following the second dose of the two-dose vaccine candidate—the time period for safety data specified in FDA EUA guidance for emergency use applications.
The submission also included solicited safety data on approximately 100 children 12–15 years of age, the companies added.
Of the trial’s 43,661 participants, approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, the companies said.
In the U.S., 13.1% identified as Hispanic or LatinX; 10.1% as Black; 5.5% as Asian, and 1% as Native American. Globally, 26.1% was Hispanic/LatinX; 10%, Black; 4.5%, Asian; and 0.8%, Native American.
“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,” Albert Bourla, DVM, PhD, Pfizer’s chairman and CEO, said in a statement.
“We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion, and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible,” Bourla added.
Pfizer and BioNTech have studied BNT162b2, BNT162b1, and two other constructs of BNT162: a uridine containing mRNA (uRNA) candidate; and a candidate using self-amplifying mRNA (saRNA).
Pfizer and BioNTech said they will be ready to distribute BNT162b2 “within hours after authorization”—a promise echoed yesterday by General Gustave F. Perna, chief operations officer for Operation Warp Speed—the Trump administration’s effort to facilitate development and distribution of 300 million doses of COVID-19 vaccines by January.
“I can look you in the face and say to you, EUA comes, 24 hours later, vaccines will be distributed out to the American people and be ready for administration,” Perna declared yesterday at a public briefing of the White House Coronavirus Task Force.
“The planning began almost immediately following our ceremony in the Rose Garden on 15 May” announcing the creation of Operation Warp Speed, Perna added. “A couple of things we decided upfront. One, we were going to be able to deliver the vaccine within 24 hours after EUA. That is distribution 24 hours after EUA. That is distribution to the entire United States of America to include territories and metropolitan cities.”
That distribution will begin with healthcare facilities, to be followed a day later with distribution to healthcare workers and other high-risk populations: “We have a system in place to begin within 24 hours shipping that vaccines to hospitals, healthcare facilities, and 24 hours after that literally injecting that vaccine into Americans,” Vice President Mike Pence said at the briefing.
Pfizer and BioNTech repeated today previous statement that they will be able to manufacture thorugh their combined facilities up to 50 million vaccine doses globally by the end of 2020, and up to 1.3 billion doses by the end of 2021—subject to positive clinical results, manufacturing capacity, and regulatory approval or authorization.
The FDA is not the only regulatory agency worldwide that is considering BNT162b2. BioNTech and Pfizer said they have already begun rolling submissions with the European Medicines Agency and the U.K.’s Medicines & Healthcare Products Regulatory Agency (MHRA). Applications will be submitted to other regulatory agencies worldwide “in the coming days,” the companies added.
“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,” stated Ugur Sahin, MD, CEO and co-founder of BioNTech.
“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,” Sahin added.