Pfizer, BioNTech to Submit EUA Request to FDA Today for COVID-19 Vaccine

Pfizer and BioNTech will file for emergency use authorization (EUA) to the FDA today for their coronavirus disease 2019 (COVID-19) vaccine candidate BNT162b2, according to a press release.

The companies released positive results from their final analysis of its phase 3 study, which reported a 95% vaccine efficacy rate. The vaccine also showed an observed efficacy rate over 94% in adults older than 65 years of age. The submission is based on results of this study.

Operation Warp Speed (OWS) officials held a news briefing on Wednesday, in which Health and Human Services (HHS) Secretary Alex Azar, MD, said that 40 million doses of an approved vaccine could be available by the end of the year. According to Azar, this distribution would be enough to vaccinate 20 million Americans at high risk for COVID-19. The government plans to distribute doses of a vaccine within 24 hours after an EUA is approved.

According to Pfizer, the company has developed specially designed, temperature-controlled shippers for BNT162b2 that can maintain recommended storage conditions (-70°C ±10°C) for up to 15 days. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. Once thawed, the vaccine vial can be stored for up to 5 days at refrigerated (2-8°) conditions.

Additionally, Pfizer and BioNTech’s combined manufacturing network has the potential to supply up to 50 million doses globally in 2020, and up to 1.3 billion doses by the end of 2021, according to the 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,” Dr Albert Bourla, chairman and CEO of Pfizer, said in a 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.”

Reference:

1. 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