Studies to Address Emerging Variants
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.
Third Dose of BNT161b2 and Ongoing Variant Vaccine Updates
As the SARS-CoV-2 virus continues to evolve and the pandemic rages in many places, Pfizer and BioNTech are continuing with our work to understand long term immunity, the potential need for booster shots, and any threat from circulating or new variants of concern on vaccine protection. We are taking a multi-pronged scientific approach to gather data and be prepared if needed with an updated vaccine.
1) Ongoing boosting studies
Pfizer and BioNTech initiated a global Phase 3 clinical study in July 2021 in the United States, Brazil, and South Africa, to evaluate a third booster dose of its COVID-19 vaccine (BNT162b2) on immunity against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants. The Phase 3 study, which plans to enroll 10,000 participants who participated in the landmark Phase 3 trial, will evaluate the safety, tolerability, and efficacy of a third, booster dose of the COVID-19 vaccine compared to placebo.
This Phase 3 study builds on efforts we started back in February to gain an early understanding of the safety and immunogenicity of a third dose of BNT162b2.
2) Efforts against variants of concern
While Pfizer and BioNTech believe a third dose of their COVID-19 vaccine has the potential to preserve the highest levels of protective efficacy against all currently known variants, the Companies are remaining vigilant and are developing updated versions of the Pfizer-BioNTech COVID-19 vaccine to potentially address specific variants. The Companies are studying a Beta-variant-specific construct, the results of which are meant to establish a regulatory pathway for any updated vaccine that might be needed to address any future variant of potential concern, as well as a Delta-variant-specific construct. The Companies anticipate the clinical studies for the Delta-variant-specific construct to begin in August 2021, subject to regulatory approvals.
We are constantly conducting surveillance efforts focused specifically on monitoring for neutralization of emerging variants. You can learn more about the findings from this ongoing work under peer-reviewed publications.