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FDA commissioner on new COVID-19 vaccine rules: ‘Can’t be blind’

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September 3, 2025
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FDA commissioner on new COVID-19 vaccine rules: ‘Can’t be blind’
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Food and Drug Administration (FDA) Commissioner Marty Makary says the agency will not overlook anything in developing new guidelines for updated COVID-19 vaccines.

“A lot of people report vaccine injury,” Makary told “Elizabeth Vargas Reports” on Tuesday evening. “A lot of people report complications, including children who have died from the vaccine. So, we can’t just be blind.”

COVID-19 vaccine guidelines continue to be a hot button as President Trump is calling for drug companies to justify the success of the medicine nearly five years after the pandemic.

“I have been shown information from Pfizer, and others, that is extraordinary, but they never seem to show those results to the public. Why not???” Trump wrote in part on Truth Social earlier Tuesday.

The president’s critics say the Centers for Disease Control and Prevention (CDC) is being ripped apart by the vaccine debate, even though most medical experts say the evidence is clear that the vaccines worked.

FDA has timeline for new COVID-19 vaccine

Access to a COVID vaccine presently is more limited than it was four years ago. The FDA also recently narrowed its criteria for who qualifies for the vaccine.

Now, Makary said, “we have an agreement … with the large vaccine makers that make the COVID vaccine that they will conduct a randomized control placebo trial and have those results back to us by May.”

The new study, which will begin this winter, will hopefully provide answers to whether the benefits outweigh the risks of the vaccine moving forward.

“That is the question,” Makary said. “Let’s blindfold ourselves and insist that everybody take this. Look at the last administration, rubber-stamping COVID boosters every year with no updated clinical trial.”

“And we said, ‘We’re not going to keep going down this road.’ We don’t believe in COVID vaccine boosters forever unless we have evidence to support it,” the FDA chief continued. “We’re bringing back gold standard science and common sense.”

COVID-19 vaccine data released will provide transparency: NIH director

Dr. Jay Bhattacharya, director of the National Institutes of Health, feels that drug companies releasing the COVID-19 data will help more than hurt the American people.

“It’s really healthy to open up a discussion, an honest scientific discussion, uncensored, on the evidence on the COVID-19 vaccine,” he said.

Bhattacharya adds that all the mandates that were in place years ago brought about a level of distrust among the public.

“For me, the most important thing is we need to have public health be honest with the American public,” he continued “That’s, to me, that’s the upshot of the president’s take, which I really just admire.”

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