FDA Advisory Committee Convenes to Discuss Moderna Booster

October 15, 2021

Yesterday, an advisory committee to the FDA convened to discuss the use of booster shots by Moderna. The committee voted unanimously in favor (19 to 0) of a booster dose for the following groups:

• those 65+ years in age
• those 18-64 years in age who are at high risk of severe COVID-19
• those 18-64 years in age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications due to COVID-19, including severe COVID-19

This parallels the committee’s recommendation for Pfizer boosters last month. On a different note, the Moderna booster shot will be 50 micrograms, compared to doses in the primary series, which are 100 micrograms. The reason for a smaller dose comes down to observing less side effects (such as fever), without compromising an increase in antibody titers when a primary series elicited a robust immune response. Committee members clarified that a third dose (for those who are immunocompromised) is 100 micrograms. They also clarified that “risk of exposure” does not necessarily equate to being at higher risk for severe disease.

While Moderna has stated that its vaccine does not require a booster to continue preventing severe COVID-19, a booster will increase prevention of infection, as well as mild to moderate disease. 

The committee will be discussing booster doses for the Johnson & Johnson vaccine, as well as mix-and-matching doses in today’s meeting, around 1:15pm and 3:30 pm EST, respectively.