The U.S. Food and Drug Administration (FDA) is changing how it approves updated COVID-19 vaccines, focusing eligibility on older adults and individuals with underlying health conditions that put them at high risk for severe COVID-19.
The change, announced by Commissioner Dr. Marty Makary and Dr. Vinayak Prasad in The New England Journal of Medicine, reflects a shift toward what the agency describes as a more rigorous, evidence-based approval process that prioritizes stronger clinical trial data for broader population recommendations.
Going forward, updated COVID-19 vaccines will likely be recommended primarily for those most at risk of severe illness. The FDA says this more focused approach brings the United States in line with vaccine strategies already in place in the UK, Canada, and Australia. Expanded recommendations could still be considered for healthy children and adults if supported by additional data.
Supporters believe the policy shift could help rebuild public confidence in vaccines after years of mistrust.
“The emphasis on vaccine safety and caution is a welcome change and a strong step toward restoring Americans’ trust in their healthcare agencies,” said Dr. Joseph Varon, president of the Independent Medical Alliance, in a news release.
David Mansdoerfer, former HHS Deputy Assistant Secretary, also welcomed the shift.
“HHS & FDA are making a common-sense, evidence-based approach on the approval process for updated COVID vaccines,” he told The Dallas Express. The evidence has come a long way since the beginning of COVID, and it is now clear that trust in these vaccines has plummeted due to draconian mandates.”
However, some experts question the reasoning behind the new framework. Dr. Paul Offit, a member of the FDA’s independent advisory group, disagrees with the idea that previous vaccine decisions lacked solid evidence.
“We have been using an evidence-based approach to COVID-19 vaccination,” Offit said, per CNN. “But they kind of swoop in and believe that for the first time, we’re going to get … robust data, for the first time, because according to them, we don’t have that. But we do have that.”
The FDA says it remains open to reviewing new research as it becomes available.