Moderna Asks FDA to Approve Its Booster Shot for All Adults

THURSDAY, Nov. 18, 2021 (HealthDay News) — Moderna asked the U.S. Food and Drug Administration on Wednesday to allow emergency use of the company’s COVID-19 vaccine booster for all adults aged 18 years and older.

Currently, the booster is approved for people 65 years and older, along with adults in long-term care homes, those with underlying medical conditions, and those with jobs that put them at high risk for exposure, the company said in a news release. The booster is given six months after the second shot of the two-dose initial vaccination series. The Moderna booster is half the dose of the initial vaccination series: 50 mcg versus 100 mcg. New York City and some states are not waiting for federal approval and have already made Moderna booster shots available to all adults.

The Moderna vaccine has been shown to be safe overall, but is associated with a small increased risk for myocarditis, particularly in young men. “These cases are typically mild,” Moderna Chief Medical Officer Paul Burton, M.D., said at a news briefing earlier this month, NBC News reported. “While we don’t fully understand the reasons and the etiology behind this, we think that it may be driven by testosterone.” He noted that no cases of myocarditis in young men have been reported in clinical trials of the booster doses and added that the benefits of vaccination far outweigh any risks.

The FDA is expected to soon give the green light to the Pfizer COVID-19 vaccine booster shot for all adults, and it will be discussed at a U.S. Centers for Disease Control and Prevention advisory panel meeting scheduled for Friday.

NBC News Article