FDA Panel Endorses Moderna’s COVID-19 Booster Shot

An influential U.S. Food and Drug Administration (FDA) advisory committee has unanimously recommended giving booster shots of Moderna’s (NASDAQ:MRNA) COVID-19 vaccine to elderly and vulnerable Americans.

The committee vote was a crucial step before the U.S. can start administering third shots to some of the more than 69 million people who originally received Moderna’s vaccine.

The nonbinding decision by the FDA’s Vaccines and Related Biological Products Advisory Committee would bring guidelines for Moderna in line with third shots of the Pfizer (NYSE:PFE) vaccine.

Pfizer’s booster shot was approved by the FDA less than a month ago for a wide array of vulnerable Americans, including the elderly, adults with underlying medical conditions and those who work or live in high-risk settings.

While the FDA hasn’t always followed the advice of its committee, it often does. A final FDA decision on Moderna’s booster vaccine could come within days. If approved, Moderna booster shots could begin immediately for eligible Americans who completed their immunizations at least six months ago.

Booster shots have been a contentious topic for scientists, especially as many people in the U.S. and other parts of the world have yet to receive even one dose of a vaccine.

The World Health Organization is urging wealthy countries to hold off on distributing booster vaccinations, and some scientists say they aren’t convinced most Americans need booster shots right now.

When the FDA committee met last month, they rejected a proposal to distribute booster shots of Pfizer’s vaccine to the general public. Some committee members at the time said they were concerned there wasn’t enough data to make a recommendation, while others argued third shots should be limited to vulnerable populations.

The administration of U.S. President Joe Biden hopes that giving the U.S. population additional doses will ensure long-term and durable protection against severe disease, hospitalization and death as the fast-moving Delta variant of COVID-19 continues to spread.

Moderna applied for FDA authorization of its booster vaccine on September 1. Moderna has said that a third shot at half the dosage used for the first two shots was safe and produced a strong immune response in people.