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Emergency Use Authorization Request to Be Submitted to FDA Today for COVID-19 Vaccine


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Pfizer Inc and BioNTech SE announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the United States by the middle to end of December 2020.

The submission is based on a vaccine efficacy rate of 95% (P < .0001) demonstrated in the companies’ phase III clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The first primary objective analysis was based on 170 confirmed cases of COVID-19.

This submission is also supported by solicited safety data from a randomized subset of approximately 8,000 participants at least 18 years old and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of 2 months following the second dose of the vaccine candidate. The submission includes solicited safety data on approximately 100 children aged 12 to 15 years. Approximately 42% of global participants and 30% of U.S. participants in the phase III study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56 to 85 years old. To date, the data monitoring committee for the study has not reported any serious safety concerns related to the vaccine.

Additional Submissions and Manufacturing Capabilities

The companies have already initiated rolling submissions with several regulatory agencies around the world, including the European Medicines Agency and the Medicines & Healthcare Products Regulatory Agency in the United Kingdom, and intend to submit applications to other regulatory agencies worldwide in the coming days. The companies will be ready to distribute the vaccine candidate within hours after authorization.

While Pfizer and BioNTech await potential authorization or approval from regulatory agencies, the companies continue to work in collaboration with governments and Ministries of Health around the world that will distribute the vaccine, subject to authorization or approval, to help ensure it can reach those most in need as quickly as possible. Pfizer and BioNTech’s combined manufacturing network has the potential to supply up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021 (subject to clinical success, manufacturing capacity, and regulatory approval or authorization).

About the Study

The phase III clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the United States, Germany, Turkey, South Africa, Brazil, and Argentina. Participants will continue to be monitored for long-term protection and safety for an additional 2 years after their second dose.

Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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