Trump FDA overhauls COVID-19 vaccine approval to focus on older populations, high-risk individuals

The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the virus, and those older than age 65.

Dr. Vinay Prasad and Dr. Marty Makary said in their essay that the U.S. will move away from a "one-size-fits-all" paradigm that promoted COVID-19 vaccines for the vast majority of Americans.  (Getty Images)

"While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe Covid-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months," the health leaders wrote in the New England Journal. 

"The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations," they wrote. "We reject this view." 

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Americans' trust in the scientific community has cratered since the COVID-19 pandemic, Dr. Vinay Prasad and Dr. Marty Makary noted.  (AP Photo, File)

The pair added during the roundtable that Americans' trust in the scientific community has cratered since the pandemic. 

"Survey after survey shows trust in institutions like the FDA and scientists in general, it's rock bottom," Prasad said during the roundtable. "I mean, we have lower trust than Congress, and that's saying something, you know. And we need to rebuild that trust. And part of rebuilding that trust is having conversations like this, writing articles like we've done in the New England Journal, and having a common-sense evidence-based framework for rebuilding that trust." 

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The pair cited in their article in the New England Journal that "public trust in vaccination in general has declined," including for "vital immunization programs such as that for measles–mumps–rubella (MMR) vaccination, which has been clearly established as safe and highly effective."

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