WASHINGTON (TNND) — Annual COVID-19 shots for healthy young adults and children will no longer be necessary under new guidelines suggested by the Food and Drug Administration (FDA).
Top officials for the FDA said they are changing the standard of evidence required for vaccine approval in the U.S., according to an editorial published in the New England Journal of Medicine.
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,” FDA Commissioner Marty Makary and FDA vaccine chief Vinay Prasad wrote.
The FDA said moving forward, it will adopt a framework that requires proof that a vaccine can generate antibodies in people over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe COVID-19.
“Estimates suggest that 100 million to 200 million Americans will have access to vaccines in this manner,” experts said.
Just like with flu vaccines, until now, the FDA has approved updated COVID-19 shots when manufacturers provide evidence that they spark just as much immune protection as the previous year’s version.
Makary and Prasad criticized the U.S.’s “one-size-fits-all” approach and said the change will more closely align with vaccine recommendations in the U.K., Canada and Australia.
We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,” they wrote.
They also pointed out that over the past two seasons, uptake of the booster has been poor, according to the Centers for Disease Control and Prevention (CDC).
“Even health care workers remain hesitant, with less than one-third participating in the 2023–2024 fall booster program,” Makary and Prasad wrote. “There may even be a ripple effect: public trust in vaccination in general has declined, resulting in a reluctance to vaccinate that is affecting even vital immunization programs such as that for measles–mumps–rubella (MMR) vaccination, which has been clearly established as safe and highly effective.”
The FDA’s new guidance appears to align with the beliefs of Health Secretary Robert F. Kennedy Jr., who has previously mentioned wanting to aim for gold-standard science.
“The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” the editorial read. “These clinical trials will inform future directions for the FDA, but more important, they will provide information that is desperately craved by health care providers and the American people.”
