Researchers trying to devise an updated coronavirus vaccine for use this fall would have to settle on a formula as early as June to meet that deadline, federal officials said on Wednesday, even though some clinical trials are just now getting underway.
The assessment came during a daylong meeting of outside advisers to the Food and Drug Administration, who convened to strategize about what the nation’s coronavirus vaccine policy should look like moving forward. The session underscored how deeply the road ahead is studded with uncertainties.
Among the most basic questions debated: At what point would officials decide that the existing vaccines are not working well enough? And if better vaccines are deemed necessary, when might clinical trials provide answers about suitable replacements?…
“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” by fall, he said. Dr. Peter Marks, who oversees vaccine regulation at the F.D.A., also described the time frame as highly compressed, saying regulators may need to settle on a new vaccine formula by May or June if they want to switch from the existing ones.
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