(FDA) announced on Tuesday that it will limit access to seasonal Covid-19 boosters for healthy Americans
The Food and Drug Administration (FDA) announced on Tuesday that it will limit access to seasonal Covid-19 boosters for healthy Americans under 65 without clear evidence of clinical benefit.
Newly-installed FDA commissioner, Marty Makary, and Vinay Prasad, the controversial director of the Center for Biologics Evaluation and Research, laid out the new guidelines in a commentary piece published in the New England Journal of Medicine.
Top officials at the FDA outlined a new framework for approving Covid-19 vaccines, saying that the US would make the boosters available for Americans over the age of 65 and for adults and children above the age of 6 months with at least one condition that increases their risk of severe Covid-19.
They wrote that manufacturers would have to conduct randomized, controlled clinical trials before updated vaccines would receive approval for healthier people.
Elsewhere in the piece, the officials argue that the US is an outlier among countries in Europe and other high-income countries where Covid-19 boosters are recommended only for older adults and people at high risk. They estimate that more than 100 million Americans will still qualify for the annual shots under the new terms.
The US Centers for Disease Control and Prevention lists many conditions that make a person higher-risk for getting very sick from Covid, including obesity, diabetes, asthma or chronic lung disease as well as those with a compromised immune system, pregnant people and people with disabilities.
Makary, appointed by Donald Trump, and Prasad are both vocal critics of pandemic-era policies and of the government’s response to Covid-19.
The agency is overseen by the Health and Human Services, which is now run by Robert F Kennedy Jr, a long-time vaccine skeptic who has been slashing the department as part of the White House’s effort to downsize the federal government.
