To study the effect of these mutations, three engineered viruses with key mutations were tested against the panel of human sera from 20 participants in the previously reported Phase 3 trial who had been immunized with the Pfizer-BioNTech COVID-19 vaccine. Of the three recombinant variants, one has a mutation common to both the U.K. and South Africa variants (N501Y), one has mutations common to the U.K. variant (Δ69/70+N501Y+D614G), and the third has mutations common to the South Africa variant (E484K+N501Y+D614G). The sera from individuals vaccinated with the Pfizer-BioNTech COVID-19 vaccine neutralized all the SARS-CoV-2 strains tested.
Consistent with recent reports of the neutralization of variant SARS-CoV-2 or corresponding pseudoviruses by convalescent or post-immunization sera,i,ii neutralization against the virus with the three key mutations present in the South African variant (E484K+N501Y+D614G) was slightly lower when compared to neutralization of virus containing the other mutations that were evaluated. However, the Companies believe the small differences in viral neutralization observed in these studies are unlikely to lead to a significant reduction in the effectiveness of the vaccine.
Pfizer and BioNTech are encouraged by these early in vitro study findings and are currently evaluating the full set of mutations in the spike protein of the South African variant. While these findings do not indicate the need for a new vaccine to address the emerging variants, the Companies are prepared to respond if a variant of SARS-CoV-2 demonstrates evidence of escaping immunity by the COVID-19 vaccine. Pfizer and BioNTech will continue to monitor emerging SARS-CoV-2 strains and continue to conduct studies to monitor the vaccine’s real-world effectiveness. Pfizer and BioNTech believe that the flexibility of BioNTech's proprietary mRNA vaccine platform is well suited to develop new vaccine variants if required.
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 Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com.
About Pfizer: Breakthroughs That Change Patients' LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.
About BioNTechBiopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.