Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of an Additional Booster Dose of their COVID-19 Vaccine for Older Adults

•    Submission based on real-world safety and efficacy data from Israel 
•    Data showed rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among individuals who received an additional booster dose of Pfizer-BioNTech COVID-19 Vaccine compared to individuals who received only an initial booster

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of an additional booster dose for adults 65 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. The submission is based on two real-world data sets from Israel analyzed at a time when the Omicron variant was widely circulating. These data showed evidence that an additional mRNA booster increases immunogenicity and lowers rates of confirmed infections and severe illness.

An analysis of Israeli Ministry of Health records was conducted for over 1.1 million adults 60 years of age and older who had no known history of SARS-CoV-2 infection and were eligible for an additional (fourth dose) booster. These data showed rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among individuals who received an additional booster dose of the Pfizer-BioNTech COVID-19 Vaccine administered at least four months after an initial booster (third) dose compared to those who received only one booster dose.

Also included in the submission are results from an ongoing, open-label, non-randomized clinical trial in healthcare workers 18 years of age and older at a single study center in Israel who had been vaccinated with three doses of the Pfizer-BioNTech COVID-19 Vaccine. Among the 154 (out of 700) participants who received an additional booster (fourth) dose of the Pfizer-BioNTech COVID-19 Vaccine at least four months following the initial booster, neutralizing antibody titers increased approximately 7-fold to 8-fold at two and three weeks after the additional booster (fourth) dose compared to five months after the initial booster (third) dose.

Emerging evidence, including data from Kaiser Permanente Southern California (KPSC), suggests that effectiveness against both symptomatic COVID-19 1,2,3,4,5 and severe disease1,5 caused by Omicron wanes 3 to 6 months after receipt of an initial booster (third) dose. Thus, additional booster doses may be needed to ensure individuals remain adequately protected. The data being reviewed by the FDA from Israel suggest that an additional booster dose of the Pfizer-BioNTech COVID-19 Vaccine administered at least 4 months after an initial booster dose could restore antibody titers to peak post-third dose titer levels, 7 improve protection against both infection and severe disease in individuals 60 years of age and older in Israel,7 and have a similar safety profile to that of previous doses.6 The data from KPSC were provided to the FDA as an example of waning of the Pfizer-BioNTech COVID-19 Vaccine, but have not been reviewed by the agency.

The Pfizer-BioNTech COVID-19 Vaccine is currently authorized as a single booster dose administered at least five months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals 12 years of age and older. A single booster dose can also be administered to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 Vaccine. Clinical and real-world data continue to show that people who are vaccinated, particularly those who have received a booster, maintain a high level of protection, particularly against severe disease and hospitalization. The companies remain vigilant and continue to collect data to explore new vaccine approaches and regimens to reduce the risk of infection and the risk of severe COVID-19 disease.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

About Pfizer: Breakthroughs That Change Patients’ Lives
At 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 170 years, we have worked to make a difference for all who rely on us.
About BioNTech
Biopharmaceutical 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.

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