Pfizer Starts Process for US Approval of COVID-19 Booster Shot

By Reuters Staff

August 26, 2021

(Reuters) - Pfizer Inc and BioNTech have started the process for a full approval of a booster dose of their COVID-19 vaccine in people aged 16 years and older, the drugmakers said on Wednesday.

The companies intend to complete the submission by the end of this week. This could potentially pave the way for a third dose that can be offered to people with compromised immune systems.

U.S. officials have said that COVID-19 vaccine booster shots will be made widely available to Americans starting Sept. 20.

Earlier this week, U.S. regulators granted full approval to the two-dose vaccine based on updated data from the companies' clinical trial and manufacturing review.

A third dose of the Pfizer-BioNTech vaccine is not currently authorized for broad use in the United States. However, under the amended Emergency Use Authorization, a third dose was authorized for administration to individuals at least 12 years of age who were immunocompromised.