I am happy to share with you that Pfizer and our collaborator, BioNTech, announced positive efficacy results from our Phase 3, late-stage study of our potential COVID-19 vaccine. The vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.
The results demonstrate that our mRNA-based vaccine can help prevent COVID-19 in the majority of people who receive it. This means we are one step closer to potentially providing people around the world with a much-needed breakthrough to help bring an end to this global pandemic.
This is a first but critical step in our work to deliver a safe and effective vaccine.
It’s important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone. More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study.
We estimate that a median of two months of safety data following the second and final dose of the vaccine candidate - required by FDA’s guidance for potential Emergency Use Authorization – will be available by the third week of November.
We are also generating data to show that our vaccine can be consistently manufactured to meet quality standards.
Efficacy, safety and consistent manufacturing are the three requirements that are needed before we are able to file for authorization.
We look forward to sharing additional updates in the coming weeks and will continue to work closely with regulatory authorities to provide access to our anticipated vaccine for those who need it most.
I want to thank the thousands of people 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 are dedicating their time to this crucial endeavor.
We could not have come this far without the tremendous commitment of everyone involved. Their dedication and courage are the reasons we continue to believe that science will win.
Thank you all.
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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 16 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 at www.cvdvaccine.com.
