Pfizer, BioNTech to submit Emergency Use Authorization to the US FDA – COVID-19

In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K., and plan to submit applications immediately to other regulatory agencies around the world

Based on current projections, 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; the companies will be ready to distribute the vaccine within hours after authorization

BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date

NEW YORK & MAINZ, Germany (STL.News) Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.

The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 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 also is supported by solicited safety data from a randomized subset of approximately 8,000 participants ≥18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate.  The submission also includes solicited safety data on approximately 100 children 12-15 years of age.  Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. To date, the Data Monitoring Committee (DMC) for the study has not reported any serious safety concerns related to the vaccine.

“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.  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,” said Dr. Albert Bourla, Pfizer Chairman and CEO.  “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.”

“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,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.  “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 companieshave already initiated rolling submissions with several regulatory agencies around the world, including the EMA and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and intend to submit applications to other regulatory agencies worldwide in the coming days.  In some cases, governments may have regulatory pathways similar to an EUA.  The companies will be ready to distribute the vaccine candidate within hours after authorization.

Pfizer and BioNTech are extremely grateful to the study volunteers and investigative site staff in the clinical trial program, as their involvement was crucial to today’s important milestone in the companies’ efforts to address the COVID-19 global pandemic.

The BNT162b2 vaccine candidate is not currently approved for distribution anywhere in the world.  Both collaborators are committed to developing this novel vaccine with preclinical and clinical data at the forefront of all their decision making.

NOTE: this is NOT the complete release.

View complete release at: https://investors.pfizer.com/investor-news/press-release-details/2020/Pfizer-and-BioNTech-to-Submit-Emergency-Use-Authorization-Request-Today-to-the-U.S.-FDA-for-COVID-19-Vaccine/default.aspx

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