It is with great pride and joy – and even a little relief – that I can say that our request for Emergency Use Authorization for our potential COVID-19 vaccine is now in the FDA’s hands.
This is a historic day for science. It took just 248 days to get from the day we announced our plans to collaborate with BioNTech to our FDA submission date. We have operated at extraordinary speed in our clinical development program from concept to regulatory filing, while always maintaining our focus on safety.
So many things went into making this happen: advances in technology, tremendous collaboration, thousands of courageous trial volunteers around the world, and, of course, the purpose-driven colleagues at both companies.
Today we were able to submit a very robust data set that we believe meets the FDA’s high standards. Our vaccine candidate has demonstrated efficacy of 95% against COVID-19, with no serious safety concerns observed to date.
Of course, the journey is not yet complete. In addition to today’s submission to the FDA, we have already initiated rolling submissions in Australia, Canada, Europe, Japan and the UK, and we plan to submit immediately to other regulatory agencies around the world.
Lastly, we will continue the work already underway to make sure we can begin shipping the vaccine immediately after authorization or approval. Based on current projections, we expect to produce globally up to 50 million doses in 2020 – and up to 1.3 billion doses by the end of 2021.
I want to thank everyone who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who have been working day and night to help ensure that science will win.
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The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheet here.
