FDA Advisory Panel Unanimously Recommends Moderna Booster Shot (Comprehensive)

Second After Pfizer
For Elderly and High-Risk Groups

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] The advisory committee of the U.S. Food and Drug Administration (FDA) unanimously recommended Moderna's COVID-19 vaccine booster shot on the 14th (local time). This is the second recommendation following Pfizer last month.

According to AP News and others, the FDA advisory committee, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), made this decision by unanimous vote at the meeting that day.

The eligible recipients are high-risk groups including those aged 65 and older who received two doses of the Moderna vaccine at least six months ago, patients with underlying conditions, immunocompromised individuals, and healthcare workers. The administered dose is half of the regular first and second doses.

This is the same eligibility criteria as the Pfizer booster shot approved by the FDA last month. Although Pfizer and Moderna applied for approval for the general adult population, health authorities significantly narrowed the target group.

The FDA advisory committee's decision is a recommendation and not binding, but the FDA generally accepts it. However, even after FDA approval, the Centers for Disease Control and Prevention (CDC) must go through a discussion process for use within the United States.

Moderna emphasized at the meeting that the booster shot is effective in preventing breakthrough infections or illnesses with mild to moderate symptoms. However, many advisory committee members felt that the related clinical trial data was insufficient.

The advisory committee's recommendation despite these concerns was made considering comprehensively that the Pfizer booster shot has already been approved. Some members pointed out, "The FDA set a bad precedent by approving the Pfizer booster shot citing an emergency situation."

The FDA had planned to discuss expanding the booster shot eligibility for Pfizer and Moderna to the general adult population that day, but the plan was scrapped as some members opposed it.

Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia and an advisory committee member, criticized, "I do not agree at all with expanding booster shot administration to the general adult population," adding, "It could send the wrong message that (general adults) are not protected from COVID-19 unless they receive a third dose."

This content was produced with the assistance of AI translation services.