Future access to COVID vaccinations could be limited because of a stricter FDA policy
The FDA’s New Direct Directive on Vaccines for Covid-19 Associated Hospitalizations: A Warning to the Public and the Public’s Choice
Many Americans don’t know what to think about getting a seventh or eighth or ninth or tenth COVID-19 booster.
The rate of covid-19-associated hospitalizations was 71.2 per 100,000 people during the 2024–25 season, according to the CDC — although hospitals haven’t been required to report covid-related hospital admissions to HHS since May of last year. Vaccines are important for people with weakened immune systems. The FDA’s new directive raises questions about whether people considered healthy will be able to get vaccinated if they want to protect someone close to them who’s at greater risk.
It is possible that the changes will mean that yearly boosters are not recommended for everyone. They’d be aimed at people with health risks. For other adults and children additional studies would have to show the benefits of vaccination outweigh risks.
This multiyear campaign of booster after booster and distrust of the American public is over. There is no gold-standard science to support this for low risk Americans, according to the new director of the FDA’s Center for Biologics Evaluation and Research.
The federal health officials say the steps will bring the US in line with other countries that have taken a more high income approach to vaccines than the U.S.
From 100 million to 200 million Americans would be eligible for COVID vaccines under the new approach, according to an estimate cited in the journal article. That’s a change from the current approach, which recommends vaccines for almost everyone.
“Secretary Kennedy had made it clear that he would never take vaccines away from anyone,” Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said in an interview with NPR, referring to Health and Human Services Secretary Robert F. Kennedy Jr., who oversees the FDA. “This violates that in every way possible” because if insurance companies won’t pay for the vaccine many people simply won’t be able to afford it.”
Critics think that the new requirements are unnecessary because of the overwhelming evidence that COVID vaccines are safe and effective.
They also worry the regulatory move sends the misleading message that the vaccines have not been adequately evaluated and that it would limit the availability of the vaccines because insurers would no longer pay for the shots for everyone.
Others are of the opinion that the new approach doesn’t take other issues into account, such as the fact that younger people with better genes can get long carbon dioxide and immunization can help reduce that risk.
Others at low risk themselves may want to get vaccinated to protect other people, such as older family members and those with weak immune systems, Hotez says.
There’s no group that is not at risk since there’s no vaccine that will eradicate the spread of the disease, and there’s a vaccine that works.
Paul Offit, the Associated Press, and Peter Marks, Director of the Center for Biologics Evaluation and Research, and Comments on “Vaccines for the Prevention of Covid-19”
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Paul Offit, a vaccine scientist, and professor of pediatrics at Children’s Hospital of Philadelphia, told The Associated Press that vaccines would become less insurable and less available.
A commentary by the New England Journal of Medicine states that they do not know whether a woman with a normal number of Covid-19 vaccines will benefit from the seventh dose.
But previous CDC studies have shown that getting a booster can help prevent mild to moderate cases of covid up to six months after getting the shot regardless of whether a person is at higher risk or not, Offit tells The Associated Press. The Centers for Disease Control and Prevention suggests that getting a vaccine can make a illness shorter and less severe if someone does get sick.
Peter Marks said in his resignation letter that he wanted to resign from his post as director of the FDA’s Center for Biologics Evaluation and Research because he felt that truth and transparency were not desired by the Secretary.
The US Food and Drug Administration (FDA) has issued a directive saying that COVID-19 vaccines are “safe and effective” even if a person is at higher risk for contracting the virus. It added that people at low risk would be able to get vaccinated, while those at higher risk would be asked to get a booster shot.