Pfizer starts process for U.S. approval of COVID-19 booster shot

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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.