FDA Stops Recommending COVID-19 Boosters for Healthy People, Introduces Stricter Approval Standards

The Food and Drug Administration (FDA) has stopped recommending COVID-19 booster shots for healthy adults and children and introduced new standards for approval.

The Details: Martin Makary, the FDA commissioner, and Vinay Prasad, the head of the FDA’s vaccine division, unveiled the new policy in a paper published in the The New England Journal of Medicine Tuesday. The FDA's new strategy will require that randomized controlled trials show clinical outcomes, such as fewer infections or hospitalizations, before granting full approval of a COVID-19 booster shot. The requirement will be costly for pharmaceutical companies and could potentially limit who gets new vaccines each year. For adults 65 and older and for people as young as 6 months who have underlying health conditions, the FDA will continue to accept immunogenicity data for approval.

For Context: "The original Covid-19 shots were tested in large, randomized controlled trials against placebos. Subsequent versions, updated to match new strains, were tested to ensure they triggered immune systems to fight the virus," according to The Wall Street Journal (Center bias). The FDA previously recommended annual shots for all Americans above six months old. Makary and Prasad noted low uptake for Covid-19 vaccines and said more evidence would increase trust in the shots. 

Key Quotes: “We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,” They wrote. However, Dr. Paul Offit, who serves on an FDA vaccine advisory committee, said, “I don’t think this is going to do anything to make vaccines safer, more effective or to lessen concerns people have about public health agencies.”

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