In a thrilling twist reminiscent of a medical thriller plot, the FDA has declared that many Americans will not see the green light for COVID-19 vaccine approvals without robust trial data to back them up. This announcement was made on May 20, with officials emphasizing that the trials are essential for ensuring the American public isn’t subjected to a perpetual cycle of booster shots based on little more than hope.
FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, who leads the FDA’s Center for Biologics Evaluation and Research, explained that the new vaccine approval framework is structured in two distinct tiers. For those aged 65 and older, or for individuals with certain risk factors that put them at higher risk for severe COVID-19 outcomes, manufacturers will only need to demonstrate that a vaccine can stimulate antibody production. Meanwhile, for everyone else—those who are young and sprightly without risk factors—the FDA is calling for rigorous randomized controlled trials to showcase that a vaccine actually prevents symptomatic COVID-19 and its more sinister side effects, such as mortality.
“The FDA can only approve products if it concludes, based on scientific evidence, that the benefits outweigh the risks. We simply need more data to have that confidence for younger individuals at low risk of severe disease,” Prasad stated in prepared remarks from the FDA’s headquarters in Maryland.
These trials won’t be an annual affair, but they’re expected to occur every few years. An estimated 100 million to 200 million Americans will fall into that first tier, according to estimates from a New England Journal of Medicine article.
“Finally, the FDA is acknowledging the need for ‘evidence-based medicine’ and controlled trials to support the concept of unending boosters,” remarked Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons, in an email to The Epoch Times.
While Novavax chose to remain tight-lipped, Pfizer and Moderna were nowhere to be found for comment. However, Dr. Sean O’Leary, chair of the American Academy of Pediatrics’ Committee on Infectious Diseases, expressed his concerns regarding the FDA’s decision to limit COVID-19 vaccine availability. “Vaccination provides significant protection from post-COVID conditions,” he argued. “As demonstrated by the current measles outbreak, lower vaccination rates lead to more disease. Widespread access to immunizations keeps our communities and children healthier.”
In a not-so-distant memory, the FDA had previously approved updated versions of the Pfizer and Moderna vaccines for most Americans in 2024, extending emergency authorization despite the absence of trial data for those formulations. Not to be overshadowed, the agency also approved Novavax’s COVID-19 vaccine for adults aged 65 and older, while those aged 12 to 64 could receive it only if they had high-risk conditions.
Currently, the Centers for Disease Control and Prevention recommends that individuals aged six months and older receive one of the latest COVID-19 vaccines. However, only 13 percent of children and 23 percent of adults have bothered to follow this guidance.
Makary and Prasad pointed out that numerous other nations, including Australia and Germany, limit vaccine recommendations to specific populations. “While high-income countries generally restrict vaccine recommendations to older adults or those at high risk for severe COVID-19, the U.S. has adopted a one-size-fits-all approach, granting broad marketing authorization to all Americans over six months old,” they noted. “This policy has sometimes been defended by suggesting that the American public lacks the sophistication to understand age- and risk-based recommendations. We reject this view.”
Despite the impressive speed with which COVID-19 vaccines were developed—a genuine scientific triumph—the benefits of repeated dosing remain murky. The proposed trials will evaluate the prevention of symptomatic COVID-19, with secondary outcomes such as severe disease, hospitalization, and death. Participants who contracted COVID-19 within the past year will be monitored for at least six months to ensure that any initial booster benefits hold up over time. The control group could receive a saline placebo, a method that has not been lost on those familiar with the scientific method.
“Ultimately, these studies can provide assurance that the American strategy of continuous booster shots is indeed grounded in evidence,” they concluded.
Health Secretary Robert F. Kennedy Jr. recently expressed a commitment to requiring placebo-controlled trials for new vaccines—a move that raises eyebrows and expectations alike. Orient emphasized that the FDA should have previously disclosed the safety risks associated with the vaccines.
The FDA has been redirecting requests for comment to the Department of Health and Human Services. A spokesperson for the department informed The Epoch Times that current vaccine safety systems are inadequate and that efforts are underway to build better systems.
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