FDA Panel Votes Overwhelmingly Against Approving Pfizer COVID-19 Booster Shots

The Epoch Times

The U.S. Food and Drug Administration (FDA) advisory panel on Friday voted 16-3 to recommended against providing booster shots of the Pfizer COVID-19 vaccine for individuals aged 16 and older.

Throughout the meeting, independent scientists to the FDA struck a skeptical tone on the need for boosters, or third doses, for Pfizer’s mRNA COVID-19 vaccine for the general public. The advisory panel’s discussion is the first major test for the Biden administration’s vaccination agenda as top health officials last month announced they would try to roll out boosters for everyone by Sept. 20.

While U.S. health officials, some other countries and vaccine makers have argued that boosters are needed, many scientists, including some inside the FDA and the U.S. Centers for Disease Control and Prevention (CDC), have disagreed. Booster doses have been previously recommended by the CDC for immunocompromised individuals.

But to boost arguments against boosters being recommended for the general population, an FDA slide said the risk of COVID-19 for a or healthy 30-year-old is just 0.0004 percent, or 1 in 250,000. Some recommended a booster for older individuals but several experts said they want more data about whether the booster shots can contributed to myocarditis.

Dr. James Hildreth, a voting member on the FDA expert panel, said that he “[has] a serious concern of myocarditis in young people,” referring to a type of heart inflammation. The FDA previously issued warnings that while rare, Pfizer and Moderna vaccines could cause myocarditis among younger individuals.

“I honestly don’t think there is enough good quality data at this point to make an informed decision,” Brittany Kmush, an epidemiologist at Syracuse University, said of the Israeli study, noting the 12-day follow-up period and the variability of the authors’ estimates.

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