Studies to Address Emerging Variants

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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.

Third Dose of BNT161b2

In February 2021, Pfizer and BioNTech initiated an evaluation of the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine to understand the effect of a booster on immunity against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants.

What are the objectives of the third dose trial with participants from the Phase 1 study?

This study will evaluate the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine to understand the safety and impact of a booster dose on immunity against COVID-19 caused by the circulating SARS-CoV-2 variants.

Who will be participating in the third dose trial? How many people are you planning to enroll?

The study will draw upon participants from the original U.S. Phase 1 study who will be offered the opportunity to receive the 30 microgram booster of the current vaccine at least six months after receiving the initial two-dose regimen. The study will evaluate up to 144 Phase 1 participants in two age cohorts, 18-55 and 65-85 years of age.