'Taking away vaccine': No Covid jab for healthy adults in US? FDA to limit vaccine to 65+ and high-risk groups

The US Food and Drug Administration (FDA) has announced that future coronavirus vaccine approvals will focus only on older adults and those with health conditions that increase the risk of serious illness.

The move marks a significant change in vaccine policy, which until now encouraged wide public access, including for healthy individuals and children.

Under the new approach, updated Covid-19 vaccines are likely to be available this autumn only for people aged 65 and older, and for those over 6 months old who have conditions such as diabetes, asthma, obesity, cancer, or are pregnant.

According to FDA estimates, more than 100 million Americans would still qualify under these revised guidelines.

Healthy under-65s may no longer get free Covid shots

It remains unclear whether healthy people under 65 will be allowed to get vaccinated, or whether insurers will cover the cost if they are. Some experts warn that if the recommendation is not extended to include these groups, they might have to pay out of pocket.

“If they do not make it permissive, meaning that individuals who are not in a risk group or who are under 65 years of age want to be vaccinated, it’s likely now that payers will not pay for that vaccine,” said infectious-disease expert Michael Osterholm, as per The Washington Post. “Therefore, in a sense, it’s the equivalent of taking away a vaccine from someone,” he added.

CDC could make room for broader access

It will be up to the Centres for Disease Control and Prevention (CDC) to decide who should get the vaccine, within the limits of what the FDA allows.

FDA to demand stronger data for healthy groups

In a New England Journal of Medicine article, FDA Commissioner Marty Makary and vaccine regulator Vinay Prasad explained that vaccine makers will now need to carry out full clinical trials before the FDA approves Covid vaccines for healthy people aged 6 months to 64 years.

“The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” wrote Makary and Prasad. “These clinical trials will inform future directions for the FDA, but more important, they will provide information that is desperately craved by health care providers and the American people,” they added.

For now, the agency says it will “encourage” vaccine manufacturers to conduct these trials after they receive approval for high-risk groups, a costly and time-consuming process.

Most adults fall under high-risk category

The CDC has said that around 74% of American adults have at least one condition that puts them at a higher risk of serious COVID-19 outcomes. The policy change, therefore, still leaves a majority of adults eligible.

The FDA’s new direction follows a wider shift in the pandemic response, with most people now having some level of immunity from previous infections or vaccinations. Covid is also causing fewer severe cases overall, although it still poses a danger to vulnerable individuals.

Vaccine policy now in political spotlight

The Trump administration has raised questions recently about how vaccines are tested for safety, adding uncertainty about whether updated jabs will be available on time in the autumn. Robert F. Kennedy Jr., who now heads the Department of Health, has publicly challenged current vaccine practices and called for changes in the testing process.

Kennedy, a long-time critic of vaccinations, has falsely claimed the Covid vaccine is “the deadliest ever made”. However, he now insists his aim is to improve vaccine data quality. His department has since indicated plans to re-examine how coronavirus vaccines are developed and approved.