“FDA Plans to Limit COVID-19 Vaccines to High-Risk Groups”
In a significant policy shift, the U.S. Food and Drug Administration (FDA) announced Tuesday that it will narrow its approval for updated COVID-19 vaccines to Americans over 65 and individuals with at least one health condition that places them at heightened risk for severe illness. This change marks a departure from previous years, when vaccines were broadly recommended to the general population, including children and healthy adults.
Under the new framework, updated shots will likely become available this fall for high-risk individuals, including those with asthma, diabetes, cancer, obesity, and pregnant women. FDA officials estimate more than 100 million Americans will be eligible under the revised criteria.
What remains uncertain is whether healthy individuals under 65 will have access to the updated vaccines—or if insurers will cover them. Public health experts, such as Dr. Michael Osterholm of the University of Minnesota, warned that without clear permissions, payers may decline to fund vaccines for those outside the approved groups, effectively limiting access. “It’s the equivalent of taking away a vaccine from someone,” Osterholm said.
Traditionally, it is the Centers for Disease Control and Prevention (CDC) that sets vaccine recommendations. The CDC’s advisory panel could add language allowing broader access, ensuring insurance coverage for individuals who still want protection. Dr. William Schaffner, a member of the CDC’s COVID-19 working group, said such a line could safeguard access for those “very focused on prevention.”
FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, recently appointed as the agency’s top vaccine regulator, outlined the agency’s new position in an article published in the New England Journal of Medicine. They emphasized the need for rigorous, randomized clinical trials to support vaccine use in low-risk populations.
“The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” they wrote, arguing that this data will inform future regulatory decisions and improve transparency for healthcare providers and the public.
According to CDC data, roughly 74% of adults in the U.S. have at least one underlying condition that increases the risk of severe COVID-19.
This policy shift occurs amid broader changes in federal health leadership. Dr. Prasad replaced Dr. Peter Marks, who had overseen the rapid development of COVID-19 vaccines and was dismissed by the Trump administration in March. Robert F. Kennedy Jr., now serving as Health Secretary, has publicly expressed skepticism toward the safety testing of vaccines and is leading efforts to reform vaccine approval standards, sparking debate among medical experts.
Kennedy’s appointment and recent comments have raised alarms within the scientific community. Critics argue that undermining trust in established vaccine protocols could have lasting consequences on public confidence. While Kennedy has claimed he seeks better data, his past remarks—such as calling the COVID-19 vaccine “the deadliest ever made”—continue to generate controversy.
Both Pfizer and Moderna responded cautiously to the FDA’s new framework. Pfizer said it is reviewing the agency’s guidance and emphasized the extensive safety data generated from administering its vaccine to over one billion people. Moderna pledged to provide the data needed to support continued access to updated vaccines for Americans.
Ethical questions are also emerging around the clinical trials proposed by the FDA. Some public health experts worry that enrolling healthy adults in randomized trials where some may receive a placebo could be ethically problematic, especially for those over 50, a group still recommended to receive the vaccine under current guidelines.
The CDC’s Advisory Committee on Immunization Practices is scheduled to meet June 25 to vote on new COVID-19 vaccination recommendations for the fall. If adopted, the updated guidance would replace the standing universal recommendation with a more targeted one aligned with the FDA’s revised approval criteria. Once ratified, insurance companies would be required to cover the vaccines for eligible groups without out-of-pocket costs.
As COVID-19 continues to pose health risks—albeit with reduced severity for most—public confidence in vaccines remains mixed. According to a recent KFF poll, just over half of U.S. adults express confidence in the safety of COVID-19 vaccines, with opinions divided sharply along political lines.
The FDA’s decision comes just days before a scheduled meeting of its independent advisory committee, which is set to recommend the specific strain of COVID-19 vaccine to be used in the coming season.
DailyClout will continue to provide updates as more details emerge.
Source article posted here: https://www.washingtonpost.com/health/2025/05/20/covid-vaccine-elderly-high-risk-fda
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