FDA Narrows COVID Vaccine Approvals to Seniors and High-Risk Groups — But Millions Still in the Crosshairs

In a significant policy shift, the U.S. Food and Drug Administration (FDA) announced it will now limit approvals of updated COVID-19 vaccines to seniors over 65 and individuals with high-risk health conditions, including depression, obesity and immune compromise.

This marks a major retreat from the agency’s previous blanket policy, which approved COVID vaccines for nearly all age groups, including babies as young as six months.

Under the new framework, healthy individuals between 6 months and 64 years old will require new, outcome-based clinical trials — showing clear benefits like reduced illness or hospitalization — before receiving future COVID shots. However, for high-risk groups, no new trials will be needed, and approvals can still be based solely on antibody response.

The shift comes as CDC insiders reportedly plan to stop recommending the shots for pregnant women, children, and teens, although no formal update has been issued.

FDA officials Dr. Vinay Prasad and Dr. Marty Makary, who co-authored a New England Journal of Medicine piece outlining the new approach, acknowledged that U.S. vaccine policy has been far more aggressive than that of other developed nations. They also cited plummeting booster uptake and growing public distrust in vaccination.

Despite this recalibration, the agency insists it is not anti-vaccine and remains committed to future vaccine development — while declining to discuss unresolved long-term safety concerns and the need for greater informed consent.

While the new policy may appear more cautious, Prasad said between 100-200 million Americans would still be eligible for the shots.

The FDA’s vaccine advisory panel is set to meet May 22 to determine the makeup of the next round of COVID shots.

CHD Canada will be watching closely as thus far, there has been no new announcements from Health Canada. 

Read the original CHD article from The Defender HERE.

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