Pfizer-BioNTech, Moderna Set To Get FDA Nod For Omicron Booster Shots As Early As Wednesday: Report

Booster shots for Omicron variants of the novel coronavirus could officially be made available in the U.S. just after Labor Day, Politico reported on Monday.

What Happened: The Food and Drug Administration (FDA) will likely authorize the booster shots of Pfizer, Inc. (NYSE: PFE)/BioNTech SE (NASDAQ: BNTX) and Moderna, Inc. (NASDAQ: MRNA) as early as Wednesday, the report said, citing people with the knowledge of the matter.

Pfizer and Moderna filed for emergency use authorizations last week.

In June, the FDA asked vaccine makers to develop modified vaccines by adding an omicron BA.4/5 spike protein component to the current vaccine composition to create a two-component or bivalent booster vaccine. The agency had said then these boosters would be used in the U.S. at the beginning of fall 2022.

The Center for Disease Control and Prevention said in a release earlier this month its Advisory Committee on Immunization Practices will convene a meeting for discussing potential recommendations after the FDA’s emergency authorization comes through.

See also: Moderna Entangles Pfizer/BioNTech In COVID-19 Vaccine Patent Lawsuits: All You Need To Know

Why It's Important: Potential authorization, according to the report, will likely help ward off the BA.4 and BA.5 Omicron variants as well as the original coronavirus strain. This assumes importance in the wake of the increase in the cases of COVID-19 incidences in the U.S.

Pfizer/BioNTech’s omicron booster will likely be authorized for people, ages 12 years and older, while Moderna’s is meant for adults, ages 18 years and older. The bivalent COVID-19 vaccines are expected to be authorized as a single dose in people who have completed a primary vaccination series.

The CDC also noted that the U.S. government has bought 175 million doses of the omicron booster for distribution.