Trump administration to stop recommending COVID-19 booster vaccine for most Americans

Donald Trump administration officials explained that the Food and Drug Administration will set conditions for COVID-19 vaccination for young adults and healthy children.

In that regard, the senior officials indicated, in guidelines published in the New England Journal of Medicine, that for adults 65 years of age and older, as well as for people as young as 6 months of age with certain preexisting health conditions, the FDA will consider that the benefits of the vaccine outweigh its potential risks if there is sufficient evidence of immunogenicity, meaning that the vaccine generates an adequate antibody response.

However, for healthy people aged 6 months to 64 years with no risk factors, the agency plans to require more rigorous evidence. This will have to come from randomized, controlled clinical trials that demonstrate concrete clinical benefits, such as a decrease in cases of infection or hospitalizations, before granting full approval of the vaccine.

"Insofar as possible, when approving a COVID-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their postmarketing commitment," the panel detailed.

The update was written by FDA commissioner Marty Makary and FDA vaccines chief Vinay Prasad.

"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 stated.