FDA Stops Recommending Covid Vaccine Boosters for Most Americans

In a paper published today in The New England Journal of Medicine, Martin Makary, the commissioner of the Food and Drug Administration, and Vinay Prasad, the newly appointed head of the FDA’s vaccine division, have unveiled a new policy in which the government will no longer recommend Covid booster shots for healthy Americans ages 64 and younger.

In addition, as of today, Covid vaccine manufacturers like Moderna and Pfizer will have to conduct trials to prove that their updated vaccines offer clinical benefits such as fewer symptoms, hospitalizations, or deaths. Previously, pharmaceutical companies only had to show that their updated booster shots produced antibodies. That less rigorous standard will still apply for people 65 and older and the immunocompromised.

It is well established that people 65 and older account for the vast majority of Covid deaths, while most children, in particular, show few effects from the virus.

In an exclusive interview with The Free Press, Prasad said that the previous one-size-fits-all approach—in which the federal government recommended Covid vaccine boosters for everyone, including healthy 6-month-olds—“fatigued” the country.