4 January 2022 - - The US Food and Drug Administration has expanded the Emergency Use Authorization of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 12 years of age and older, US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) and German biotechnology company BioNTech SE (NASDAQ: BNTX) said.

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.

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

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 five months after the primary series, which revealed no new safety concerns in adults.

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 US 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 1bn doses of the Pfizer-BioNTech COVID-19 Vaccine to low- and middle-income countries. The companies expect to deliver an additional 1 bn doses to these nations in 2022.

These doses are part of Pfizer and BioNTech's previously announced pledge to provide 2bn 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.

Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA.