Pfizer, BioNTech Submit Emergency Use Authorization Request to FDA for COVID-19 Vaccine

Pfizer and BioNTech announced their intention to apply to the FDA today for an emergency use authorization (EUA) for their coronavirus disease 2019 (COVID-19) vaccine. The companies said they expect to produce up to 50 million doses globally before the end of the year, in a statement announcing the EUA application.

The submission is based on a vaccine efficacy rate of 95% demonstrated in a phase 3 trial that enrolled participants both with and without prior COVID-19 infection, measured from 7 days after the second dose. The first primary objective analysis—efficacy in patients without prior infection—was based on 170 confirmed cases of COVID-19.

According to the companies’ announcement, the submission is also supported by solicited safety data from a randomized subset of approximately 8000 participants ages 18 years or older, as well as unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of 2 months after receiving the second dose of the vaccine. The submission also includes safety data on approximately 100 children between the ages of 12 and 15 years. Furthermore, approximately 42% of global participants and 30% of US participants in the phase 3 trial have racially and ethnically diverse backgrounds, and 41% of global participants and 45% of US participants are between the ages of 56 and 85 years.

“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,” said Albert Bourla, PhD, Pfizer chairman and CEO, in a prepared statement. “Filing in the US 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 have already initiated rolling submissions in multiple other countries, including Australia, Canada, Japan, and the United Kingdom, according to the announcement. In addition to producing up to 50 million doses globally in 2020, the release said they expect to product up to 1.3 billion doses by the end of 2021 and will be ready to distribute the vaccine within hours after authorization.

“Filing for Emergency Use Authorization in the US is a critical step in making our vaccine candidate available to the global population as quickly as possible,” said Ugur Sahin, MD, CEO and co-founder of BioNTech, in a prepared statement. “We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally.”

REFERENCE

Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the US FDA for COVID-19 Vaccine [news release]. Pfizer; November 20, 2020. Accessed November 20, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-emergency-use-authorization.