The U.S. Department of Health and Human services says it will require all new vaccines to be tested in placebo-controlled trials before they can be licensed for use.
According to an HHS spokesperson, this policy change reflects Health Secretary Robert F. Kennedy Jr.'s pledge for "radical transparency" about vaccine safety, claiming the former CDC practice suppressed information about vaccine injuries and "badly eroded trust in our public health agencies."
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"The CDC's own research has shown that the post-licensure surveillance system, VAERS, captures fewer than 1% of vaccine injuries," the spokesperson said in a statement. "It's a system that was designed to fail."
"HHS is now building surveillance systems that will accurately measure vaccine risks as well as benefits — because real science demands both transparency and accountability," the spokesperson continued.
The policy change, however, could raise questions about clearing the use for new COVID-19 booster shots, as those vaccines get updated every year to better target circulating strains of the virus. Experts warn that requiring placebo-controlled trials before clearing new versions of vaccines would delay availability of updated shots by months.
"It'll delay the process such that by the time the vaccine is approved, it may already be out of date," said Dr. Ravi Jhaveri, a professor of infectious diseases in the Feinberg School of Medicine at Northwestern University.
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The head of the Food and Drug Administration said earlier this week the agency is "taking a look" at whether it will approve new COVID-19 vaccines for the winter, citing a lack of data.
"I can't comment on any particular application," FDA Commissioner Dr. Marty Makary told CBS News. "As you know, we have a bunch of applications for those booster shots."
"I think there's a void of data," he added. "And I think rather than allow that void to be filled with opinions, I'd like to see some good data."
There are also concerns over the ethics of placebo testing established vaccines, because it could leave the group taking the placebo exposed to a known dangerous disease, according to Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University Medical Center.
"If we have a vaccine available that we know works, we can't withhold that vaccine from volunteers and give them a salt solution instead," Schaffner said.
The HHS said the new policy would apply to existing vaccines with "significant updates ... such as those addressing seasonal strain changes or antigenic drift." The agency also said it wouldn't apply to the flu vaccine because it "has been tried and tested for more than 80 years."
