The U.S. Department of Health and Human Services (HHS) announced a significant shift in vaccine policy on Wednesday, stating that all new vaccines must undergo placebo-controlled clinical trials before receiving licensure. The change, described by the agency as a “radical departure from past practices,” has raised immediate questions about the future of updated COVID-19 vaccines, which have followed a streamlined seasonal approval process since 2020.
“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure,” HHS said in a statement. “This is a radical departure from past practices.”
Since their initial emergency use authorization in 2020, COVID-19 vaccines have been updated annually using a system modeled after influenza vaccines. This approach allows the vaccines to be reformulated to match circulating variants without undergoing new placebo-controlled trials each year. The core structure of the vaccines remains consistent, while only the targeted viral strains are updated.
Experts warn that mandating full placebo-controlled trials for each new version of the vaccine could significantly delay their availability, potentially leaving high-risk populations unprotected during peak respiratory virus seasons.
“The benefit of updating vaccines annually to match circulating strains is improved antibody response for four to six months,” said Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia. “That is critical, especially for people 75 and older or those who are immunocompromised.”
It remains unclear whether the new testing requirements will apply to updated COVID-19 boosters specifically. An HHS spokesperson did not respond directly to that question, but an agency official told CNN on Saturday that “COVID vaccines, including updated versions by Pfizer and Moderna, are considered new and must meet higher scientific standards to ensure safety and efficacy.” The official contrasted these vaccines with flu shots, which have decades of safety data behind them.
The Centers for Disease Control and Prevention (CDC) is expected to continue recommending biannual COVID-19 vaccinations for older adults and immunocompromised individuals under a risk-based framework.
Speculation about the future of COVID-19 vaccine approvals intensified when the FDA missed an April 1 deadline to make a decision on full approval for the Novavax COVID-19 vaccine, which uses a traditional protein-based platform. According to a source familiar with the matter, the vaccine had been on track for approval.
Novavax later confirmed that the FDA had requested a post-marketing clinical trial as a condition for approval, adding further uncertainty about the regulatory pathway for future vaccines. The new HHS policy suggests such trials may be required prior to approval, not just post-authorization, for both new vaccines and reformulated versions from companies like Moderna and Pfizer.
“If that’s the case, it signals a fundamental shift in how COVID vaccines are regulated,” said Dorit Reiss, a law professor at UC Law San Francisco. “The FDA had adopted an approach that treated boosters like flu shots. Now they appear to be reversing that stance.”
Though the overall lethality of COVID-19 has declined, particularly due to widespread immunity, the virus continues to pose significant risks. Between September 2023 and August 2024, over 36,000 people aged 65 and older died from COVID-19, according to CDC data.
HHS also criticized the current vaccine safety monitoring infrastructure, including the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink, calling them insufficient. The agency described these systems as “templates of regulatory malpractice” and announced plans to develop new tools that will more accurately assess vaccine risks and benefits.
However, Dr. Offit pushed back strongly on those claims.
“Where is the evidence for that?” he asked. “All the available data suggest the opposite.”
He noted that the current systems were able to detect rare side effects shortly after vaccine rollout, including myocarditis in about 1 in 50,000 recipients of mRNA vaccines, and blood clotting events in approximately 1 in 250,000 people who received the now-discontinued Johnson & Johnson vaccine.
“That level of surveillance is very effective,” he added. “The idea that people have lost trust in vaccines because of poor safety monitoring systems is simply inaccurate.
Source;CNN. Com
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