The US Food and Drug Administration is about to make it harder for people to get a COVID-19 vaccine.
According to new regulatory guidance published Tuesday, the FDA won't approve vaccines for healthy adults and children without additional clinical trials, The New York Times reports, needlessly making it harder for these life-saving interventions to reach the public.
The new guidance was outlined in a paper published in the New England Journal of Medicine, whose authors, FDA vaccine division chief Vinay Prasad and agency commissioner Martin Makary, cast doubt on whether COVID booster shots offer any additional benefits to anyone younger than 65 years of age. Both were outspoken critics of vaccine mandates during the COVID-19 pandemic, the NYT noted.
Pointing to how European nations typically confine vaccine recommendations to older adults and those at severe COVID risk, Prasad and Makary also criticize the US's policy of adopting a "one-size-fits-all regulatory framework" for marketing vaccines.
Now, they plan to reverse that by demanding a more stringent review process for vaccines for groups that aren't high-risk.
"The FDA's new COVID-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science," Prasad and Makary wrote in the paper. "The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk."
Many experts think this action goes too far.
"This is overly restrictive and will deny many people who want to be vaccinated a vaccine," Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University, told the NYT, adding that the new guidance does "not make sense from a public health perspective."
The policy shift reflects the Trump administration's open hostility towards vaccines — with no figure exemplifying this more than Robert F. Kennedy Jr, who has long been an outspoken anti-vaxxer and now chairs the Department of Health and Human Services, which the FDA falls under.
RFK's tenure has already seen one of the worst measles outbreaks in the country since the disease was declared eliminated within its borders a quarter century ago. While RFK did eventually endorse the measles vaccine, his decision angered many in the Trump base — an alarming sign that, like a pernicious virus, the anti-vaxx sentiment was thriving.
To justify this latest policy, the FDA authors argue that it's unclear if there are any real benefits for administering additional COVID boosters to people outside of the most at-risk groups — contrary to a mountain of scientific evidence.
"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 in the paper.
But some studies — including from the CDC itself — have, in fact, shown that boosters offer long-term COVID protection for patients who take multiple doses, even among those who had already recovered from previous infections. If there was evidence showing that loading up on boosters had serious side effects, that'd be a different story. But there simply isn't.
Even more questionably, the FDA cites the fact that less than 25 percent of Americans got booster shots over the past two seasons. This seems like an extraordinarily simple reason to start limiting vaccine access altogether.
What about the people who still want them? The authors assure that, under the FDA's new direction, 100 to 200 million Americans will still have access to COVID vaccines. That's as high as two-thirds of the country's population that they're nonchalantly brushing aside.
More on vaccines: Trump's Crackpot Secretary of Health Admits That Literally Nobody Should Be Taking Medical Advice from Him
Share This Article