Moderna Announces it Has Filed for EUA of COVID-19 Booster with FDA

On Nov. 17, Moderna announced via a press release it filed for Emergency Use Authorization (EUA) of its COVID-19 booster vaccine at the 50 µg dose level for all adults ages 18 and older with the U.S. Food and Drug Administration (FDA).

On Oct. 20, the FDA announced that it had taken action to expand the use of a booster dose for COVID-19 vaccines in certain populations, including the use of each of the available COVID-19 vaccines as a heterologous booster dose

On Nov. 9, Pfizer and BioNTech asked federal regulators to authorize their coronavirus booster shot for individuals 18 and older, citing results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety

The release from Moderna states that “The Moderna COVID-19 booster vaccine is authorized for adults ages 18 and above regardless of occupational risk factors in many international markets.”

According to an article from The New York Times by Sharon LaFraniere and Noah Weiland, “Even if federal regulators do not act on Moderna’s request this week, the FDA and the CDC are expected to allow all fully vaccinated adults access to Pfizer’s booster. At a White House briefing on Wednesday, Dr. Anthony S. Fauci, the government’s top infectious disease expert, defended the administration’s approach of broad access to boosters, saying vaccines should protect against symptomatic illness, not just hospitalization and death.”