US limits Covid-19 boosters to over-65s or those at high risk
The FDA will require vaccine makers to run fresh clinical trials before offering shots to younger and healthier individuals
The United States will limit Covid-19 boosters to people over 65 or those at risk of serious illness, while requiring vaccine makers to run fresh clinical trials before offering shots to younger and healthier individuals, officials said Tuesday.
Writing in the New England Journal of Medicine, the Food and Drug Administration’s Vinayak Prasad and Commissioner Martin Makary framed the policy shift as “evidence-based” and would align the US more closely with guidance in Europe.
But it comes as US Health Secretary Robert F. Kennedy Jnr, a long-time vaccine sceptic, pushes to remake federal public health policy.
Kennedy previously led a non-profit group that was critical of immunisation programmes, and during the pandemic petitioned the FDA to revoke Covid vaccine authorisations, citing rare side effects including heart inflammation.
Prasad and Makary praised the initial Covid-19 vaccine roll-out as “a major scientific, medical, and regulatory accomplishment”, but argued that the benefits of repeated boosters for low-risk individuals are uncertain.
They criticised the US approach of recommending boosters for all adults regardless of age or health status, calling it a “one-size-fits-all” model based on the mistaken belief that Americans could not handle more nuanced, risk-based advice.