HHS to require placebo testing of ‘all new vaccines,’ raising questions about approval of updated Covid-19 shots
CNN
The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled trials before they’re licensed for use, raising urgent questions about the system used to clear updated Covid-19 boosters each respiratory virus season.
The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled trials before they’re licensed for use, raising urgent questions about the system used to clear updated Covid-19 boosters each respiratory virus season. “Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices,” HHS said in a statement Wednesday. Covid-19 vaccines, first cleared by the US Food and Drug Administration in late 2020, have been updated each year in a system similar to that used for flu vaccines, so they can better target circulating strains of the virus. The vaccine constructs remain the same each year, but the version of the virus they protect against can be tweaked. The FDA typically selects strains for the updated vaccines in June so they can be ready for distribution by the fall. Experts warn that requiring placebo-controlled trials before clearing new versions - which could involve enrolling participants, giving some the vaccine and some a placebo shot, and waiting some period of time to assess safety and efficacy - would delay availability of updated Covid shots by months, putting vulnerable people at risk. “The advantage of updating the vaccine every year to make it more close to the circulating strain is, you get better antibody responses, so for four to six months,you will clearly have better protection against mild to moderate disease, and that matters especially for people who are more frail,” particularly people 75 and older, said Dr. Paul Offit, a vaccine scientist at the Children’s Hospital of Philadelphia. A spokesperson for HHS didn’t immediately respond to an inquiry about whether the new guidance pertains to updated Covid-19 vaccines, but an official told CNN on Saturday that “the covid vaccines, including new ones by Pfizer and Moderna, are new and must have more gold standard science to ensure safety and efficacy for the public.” The official drew a distinction from the flu shot, “which has been tried and tested” for decades.
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