The U.S. Food and Drug Administration (FDA) has announced a major shift in its COVID-19 vaccination strategy, narrowing eligibility for future shots to older adults and individuals at higher risk of severe illness.
New Standards for Vaccine Approval
In an editorial published in the New England Journal of Medicine, FDA’s Dr. Vinay Prasad and Commissioner Dr. Marty Makary explained that the agency will now require stronger clinical evidence—such as placebo-controlled trials—before approving updated vaccines for the general population.
This change will likely restrict routine COVID-19 booster access to those aged 65 and above or individuals with underlying health conditions.
Aligning With Global Practices
The FDA’s updated policy brings the U.S. in line with countries like the UK, Canada, and Australia, where updated COVID-19 shots are mainly offered to at-risk groups. Experts argue that this strategy better reflects current evidence and risk profiles.
Dr. Noel Brewer, a public health expert and CDC advisor, called the policy “a welcome development” that introduces a more globally aligned approach to vaccination.
Vaccine Makers Face New Research Demands
To expand eligibility beyond high-risk groups, companies like Moderna, Pfizer, and Novavax will now need to conduct more rigorous trials. While Moderna expressed openness to working with the FDA, Pfizer and Novavax have yet to comment.
The FDA recently approved Novavax’s COVID-19 vaccine, but only for people over 65 and those aged 12 and up with chronic conditions. Novavax CEO John Jacobs acknowledged that these groups are the most likely to seek vaccination seasonally.
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Age 50–64: A Gray Area
For adults between 50 and 64 years old, the FDA says the benefit of additional COVID-19 shots remains unclear. “We are genuinely uncertain,” Prasad said, highlighting inconsistencies in international guidelines and the need for more data.
Room for Industry-Led Research
The FDA isn’t closing the door on vaccines for younger or healthier groups—it just wants better data. “Companies are free to conduct their own randomized studies,” Prasad said. “We will consider the results.”
Public Health in a Post-Pandemic World
This shift in vaccine policy reflects broader changes in how the U.S. is approaching COVID-19—no longer as an all-population emergency, but as a manageable health risk focused on protecting the most vulnerable.
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