• The FDA is reconsidering its approach to COVID-19 vaccine approvals for the upcoming season, citing insufficient data on booster effectiveness and declining public trust in vaccination recommendations.
• FDA Commissioner Dr. Marty Makary emphasizes the need for robust clinical data before endorsing new boosters, marking a shift from earlier rapid approvals. He highlights low booster uptake among healthcare workers (85 percent declined the latest shot) and skepticism about vaccinating low-risk children.
• The CDC may narrow its vaccine guidelines, moving from universal recommendations to a risk-based approach, potentially limiting boosters to high-risk groups – a significant reversal from previous policies.
• Pharmaceutical companies and former FDA officials criticize the agency’s stricter data requirements, arguing it could delay approvals and stifle innovation. Makary defends the caution – citing past failures like Merck’s Vioxx, which was linked to deaths after rushed approval.
• The FDA’s stance reflects tensions between evidence-based policymaking and concerns that inconsistent messaging may worsen vaccine hesitancy. The outcome could reshape COVID-19 strategies and set a precedent for future health crises.

The Food and Drug Administration (FDA) is reevaluating its approach to approving Wuhan coronavirus (COVID-19) vaccines for the upcoming winter season, citing a lack of data on booster effectiveness and declining public confidence in vaccination recommendations.

FDA Commissioner Dr. Marty Makary, in interviews with CBS News and MedPage Today, emphasized the need for robust clinical evidence before endorsing new boosters. His stance is a notable shift from the rapid approvals seen during the Biden administration.

“I think there’s a void of data,” Makary told CBS News on Tuesday, April 29. “Rather than allow that void to be filled with opinions, I’d like to see some good data.”

In a separate interview with MedPage Today Editor-in-Chief Dr. Jeremy Faust also published on Tuesday, Makary acknowledged that public trust toward vaccines has eroded. He pointed to low uptake among healthcare workers and skepticism about vaccinating low-risk children.

“Look, 85 percent of healthcare workers declined the latest COVID-19 booster vaccine last fall,” Makary told Faust. “Should we accept that and just keep pounding on parents to get their healthy 12-year-old daughter a seventh COVID-19 jab this fall?” (Related: Growing number of physicians now refusing to get COVID-19 booster shots.)

The high-stakes debate over vaccine approvals

The regulator’s hesitation comes as the Centers for Disease Control and Prevention (CDC) considers narrowing its vaccine guidelines, potentially moving from universal recommendations to a risk-based approach. The CDC’s advisory committee is now debating whether to limit recommendations to high-risk groups, a move that could mark a significant policy reversal.

Makary’s stance reflects growing scrutiny of past approval processes, such as the FDA’s 2022 authorization of Omicron-targeted boosters for children as young as five without direct safety or efficacy data. But the FDA’s demand for new trials has drawn criticism from pharmaceutical companies and former officials.

Novavax, which expected full approval by April 1, now faces delays and millions in costs for additional research. Former FDA leaders Phil Krause and Luciana Borio argued in a commentary that the agency should “stick to its normal processes,” warning that shifting standards could deter innovation.

But Makary defended the decision – citing lessons from past failures like Merck’s Vioxx, a painkiller linked to thousands of deaths after its rushed approval. “I’d rather have a sound decision a few days after the target date than have another Vioxx,” he said.

The debate underscores broader tensions in public health policy. While Makary and CDC advisors push for evidence-based adjustments, critics fear inconsistent messaging will deepen vaccine hesitancy. The outcome could reshape COVID-19 strategies ahead of the winter season – and set a precedent for how regulators balance speed, science and public trust in future health crises. As the FDA weighs its next steps, the spotlight remains on whether stricter data requirements will restore confidence or further polarize the nation’s approach to pandemic preparedness.

For now, Makary’s mantra is clear: “Upholding gold standard science” comes before corporate or political pressures. The question is whether that standard will be enough to mend a fractured public health landscape.

Visit FDA.news for more similar stories.

Watch Dr. Marty Makary disclosing to Tucker Carlson that public health officials are proposing annual COVID-19 mRNA vaccinations for all people in this clip from Fox News.

This video is from the In Search Of Truth channel on Brighteon.com.

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FDA has “gone rogue” by approving new COVID booster shots without clinical trials, warns Dr. Robert Malone.

Vaccine advocate Paul Offit declares healthy Americans do NOT need a COVID “booster” shot.

EU, WHO both warn that covid ‘booster” shots are dangerous.

Sources include:

ChildrensHealthDefense.org

CBSNews.com

InsideMedicine.Substack.com

FoxNews.com

Brighteon.com