CNN
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The U.S. Department of Health and Human Services states that all new vaccines should be tested in placebo-controlled trials before they are approved for use, and raises urgent questions about the system used to clear each respiratory virus season in the updated COVID-19 booster.
“Under Secretary Kennedy’s leadership, all new vaccines will be subject to safety testing in pre-licensed placebo-controlled trials, a fundamental deviation from past practices,” HHS said in a statement Wednesday.
The Covid-19 vaccine, first removed by the US Food and Drug Administration in the second half of 2020, is updated annually with a system similar to the one used for influenza vaccines, allowing better targeting circulating strains of the virus. The vaccine structure remains the same every year, but you can tweak the version of the virus it protects. The FDA usually selects strains of the vaccine that were updated in June, so it will be available for distribution by fall.
Experts warn that you will need a placebo-controlled trial before clearing the new version – participants will be enrolled, given some vaccines and placebo shots, and that you may be waiting for some time to assess safety and efficacy.
“The benefit of renewing vaccines annually to approach circulating strains is that they reveal protection against mild to moderate diseases for 4-6 months, especially for frail people, as antibody responses improve.”
A spokesman for the HHS did not immediately respond to an investigation into whether the new guidance is linked to the updated Covid-19 vaccine, but officials told CNN on Saturday that “the new Pfizer and Moderna vaccines are new and we need more gold standard science to ensure safety and efficacy for the public.” The formula drew a distinction from shots of flu that have been “tested and tested” for decades.
Questions about the fate of the Covid vaccine began to swirl after the FDA missed the April 1 deadline to decide whether to give full approval to the Novavacs vaccine, the only non-MRNA vaccine available to protect against the coronavirus. Novavax shots use more traditional protein-based techniques. A source familiar with situations where he was not permitted to speak on behalf of the agency told CNN that the vaccine is expected to be approved.
Novavax later suggests that the FDA would require a “off-the-counter commitment” for clinical trials and that vaccine research is necessary after receiving full approval (available through emergency use permits since 2022). The latest statement from HHS will be added to questions about whether a trial is required prior to approval, not only for the Novavax vaccine, but also for the latest versions of Moderna and Pfizer.
Experts said if that were the case, it would mark a new standard for the Covid vaccine.
“The FDA obviously took an approach that has been retained for years after the deliberation process, treating Covid-19 vaccine boosters like new products,” said Dorit Reiss, law professor at UC Law San Francisco. “They adopted the standard and now they’re changing it.”
Covid-19 is not fatal due to the height of the pandemic as the population develops broad immunity through both infection and vaccination, but the virus remains murdered and is particularly dangerous for the elderly. Between September 2023 and August 2024, there were over 36,000 deaths between Covid-19 and people over 65 years of age, CDC data shows.
In a statement Wednesday, HHS also alleged that the current system for monitoring vaccine safety, including vaccine adverse event reporting systems and vaccine safety data links, did not get enough vaccine injuries and “has become a template for regulatory errors.” HHS said it is currently building a surveillance system. “We will accurately measure the risks and benefits of vaccines.”
Offit, who co-invented the rotavirus vaccine and serves an independent panel of FDA vaccine advisors, said the claim that these systems are inadequate is wrong.
“Where is the evidence?” he asked. “I argue that all the evidence is on the other side.”
He noted that within weeks the system picked up very rare side effects, such as myocarditis and myocardial inflammation. This noted that it happened in about one in every 50,000 people who received the mRNA Covid-19 vaccine and rare blood clots in people who received the current discontinued vaccine, which affected around 250,000 people.
“That’s very good,” he said. “This kind of conception that people have lost faith in vaccines due to lack of safety surveillance systems is wrong.”