Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 12 years of age and older. The booster dose is the same dosage strength (30-μg) as the dose approved in the primary series.

A booster dose of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized by the FDA for emergency use after completion of a primary series in individuals 16 years of age and older. The vaccine is also authorized for eligible individuals 18 and older who have completed primary vaccination with a different authorized COVID-19 vaccine.

"The recent rise in COVID-19 cases is concerning to all and today's decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic,2 said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations."

"The booster vaccination increases the level of immunity and improves protection against COVID-19 across all age groups that have been authorized to receive one," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "In the current situation, it is important to offer all eligible individuals a booster, particularly against the backdrop of the newly-emerging variants such as Omicron."

Real world evidence from the Ministry of Health of Israel on the administration of over 4.1 million third doses of the Pfizer-BioNTech COVID-19 Vaccine given at least 5 months after the primary series revealed no new safety concerns in adolescents 12 through 17 years of age.(1)

Additional EUA Amendments

Separately, the FDA is also amending the existing EUA to reduce the time for administration of a booster dose from at least six months to at least five months following completion of the primary series for individuals 12 years of age and older. The reduction of time between the primary series is supported by real world evidence from the Ministry of Health of Israel on the administration of third doses of the Pfizer-BioNTech COVID-19 Vaccine given at least 5 months after the primary series, which revealed no new safety concerns in adults.(1)

Finally, the FDA has expanded the current Emergency Use Authorization to include administration of a third primary series dose at least 28 days following the second dose for individuals 5 through 11 years of age who have who have been determined to have certain kinds of immunocompromise. This authorization is based on information extrapolated from an independent report evaluating safety and effectiveness of a third dose in adults who received solid organ transplants. A third primary dose of the Pfizer-BioNTech vaccine was previously authorized for administration to individuals at least 12 years of age who have been determined to have certain kinds of immunocompromise.

The companies continue to supply the vaccine, including booster doses, under their existing supply agreement with the U.S. government, which continues through April 2022. The companies do not expect that today’s news will impact the existing supply agreements in place with governments and international health organizations around the world. As of December 29, 2021, Pfizer and BioNTech have delivered 1 billion doses of the Pfizer-BioNTech COVID-19 Vaccine to low- and middle-income countries. The companies expect to deliver an additional 1 billion doses to these nations in 2022. These doses are part of Pfizer and BioNTech’s previously announced pledge to provide 2 billion doses of the COVID-19 vaccine to low- and middle-income countries between 2021 and 2022.

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 other countries, 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, health care products suppliers, 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.

1. Ministry of Health of Israel. Division of Epidemiology. (December 15, 2021). Corona Vaccine Safety [PowerPoint presentation]. Vaccine Efficacy & Safety Follow-up Committee, Israel. https://www.gov.il/BlobFolder/reports/vaccine-efficacy-safety-follow-up-committee/he/files_publications_corona_vaccine-safty-15122021.pdf