FDA Advisory Committee Rejects Pfizer Booster for General Public, Recommends It for High-Risk Groups

China News Service, Sept. 18 -- According to the US Chinese Network, on the 17th local time, an advisory committee of the U.S. Food and Drug Administration (FDA) rejected the plan to distribute Pfizer's COVID-19 vaccine boosters to the general public, but recommended vaccination for high-risk groups aged 65 and older and individuals with underlying medical conditions.

According to reports, on that day, the FDA's Vaccines and Related Biological Products Advisory Committee reviewed data submitted by Pfizer regarding its booster shots, ultimately voting 16-2 against the plan to administer boosters to the general public. Committee members expressed doubts about the safety of administering boosters to young adults and adolescents, and cited a lack of data on the safety and long-term efficacy of the booster doses.

However, in the subsequent second round of voting, the experts unanimously agreed that elderly and vulnerable populations should receive a booster dose 6 months after being fully vaccinated with the Pfizer vaccine.

According to reports, Pfizer stated in data submitted to the FDA that immunity wanes approximately six months after individuals complete the two-dose vaccination series, and that a third dose administered between six and eight months can restore immunity.

However, Krause, Deputy Director of the FDA's Office of Vaccines Research and Review, pointed out at the meeting on the 17th that the data used by Pfizer had not been reviewed by experts.

Michael Kurilla, an infectious disease expert at the National Center for Advancing Translational Sciences, also noted that research supporting booster doses relies heavily on antibody measurements, without considering other important aspects of the immune response. However, Kurilla added, "this (booster) is absolutely necessary for high-risk groups."

Additionally, the U.S. Centers for Disease Control and Prevention (CDC) also plans to hold a two-day meeting next week for a separate discussion on booster doses.

In August, the Biden administration announced plans to begin offering booster shots to the public as early as September 20. However, as the boosters had not yet received FDA approval, the plan faced criticism from some scientists and health experts, who argued that the data cited by federal health officials was unconvincing and that the rollout of booster shots was premature.