FDA advisers weigh COVID-19 booster shots for fall

Outlining a daunting timeline for development of any updated COVID-19 vaccine for next fall, federal health officials told an expert advisory panel on Wednesday that clinical trials of potential candidates would have to begin by next month, and a final formula chosen by June, to meet that tight deadline.

The assessment came during a daylong meeting of outside advisers to the U.S. Food and Drug Administration, who met to discuss what the nation’s COVID-19 vaccine policy should look like moving forward.

But time is of the essence. While numerous clinical studies of retooled shots are ongoing from vaccine manufacturers and the U.S. National Institutes of Health (NIH), they are too small to provide the kind of efficacy data that were produced for earlier vaccines, The New York Times reported.

Once larger trials are completed, vaccine manufacturers would need several months to produce hundreds of millions of doses of a reconfigured vaccine, Robert Johnson, director of an infectious disease division within the U.S. Department of Health and Human Services, told the panel, The Times reported. “If you’re not on your way to that clinical trial by the beginning of May, it is very difficult to have collectively across manufacturers enough product to meet that demand.”

Vaccine experts are still guessing at what the ever-changing pandemic will bring. Questions include whether new variants will emerge and, if so, whether they will change the virus substantially. Many experts think another surge is likely this fall. Another question is how to modify existing vaccines so they work better.

Source: Read Full Article