Syringes of Pfizer’s COVID-19 vaccine at a pop-up community vaccination center in Valley Stream, N.Y., February 23, 2021. (Brendan McDermid/Reuters) The FDA is influenced by much more than science.
On September 1, the Food and Drug Administration announced the sudden retirements of the director and deputy director of the FDA’s Office of Vaccine Research and Review. Most news reports characterized the departures of Dr. Marion Gruber and Dr. Philip Krause as resignations. The respected scientists were purportedly disturbed by political pressure from the White House and the Centers for Disease Control and Prevention to quickly approve giving COVID-19 booster shots to everyone over age twelve whose second jab was at least eight months earlier. According to Politico, the FDA is “facing a potential mutiny” by its staff and outside vaccine advisers, angry that they are being bypassed and that the FDA is being pressured by the administration into deciding on boosters prematurely.
Recent studies show antibodies against COVID waning over time. This has led some countries, such as Israel, to offer booster shots to anyone over age twelve who got their second Pfizer dose more than five months ago. This may be why President Biden muddied the waters last week by suggesting that boosters might be given to people whose vaccinations are just five months old, after the administration announced two weeks earlier that boosters will be given to people with eight-month-old vaccinations starting September 20.
Many experts in the field are not yet convinced of the need for boosters. Some contend that antibody levels tell only part of the story. They argue that although it is common for antibody levels to wane over time, T-cell immunity and immune memory often persist and recharge antibody production and the immune response if the virus attacks again. They and others worry that public-health officials may be “jumping the gun” by recommending boosters. Pfizer has submitted only early trial results to the FDA to support its claim that boosters are needed, and phase III trial data have not yet been delivered. The FDA needs the data to determine if giving a
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