U.S. HHS new testing requirements raise questions about timely approval of updated Covid-19 shots

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. Meg Tirrell CNN

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.

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