Operation Warp Speed’s Difficult Holiday Season
The US missed even its revised year-end target for COVID vaccines, but the news isn’t all bad; there’s steady progress on clinical research even as federal officials seem out of ideas for how to speed actual vaccinations.
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However, recruitment for adult trials remains robust, OWS’ Slaoui says.
Accelerated approval might soon be in the cards for COVID-19 vaccines if an immune correlate of protection can be identified through ongoing work by FDA and NIH. Meanwhile, to speed more vaccines to Americans, FDA is trying to help ramp up manufacturing. Sanofi is set to commence a Phase IIb trial with an active comparator.
Rather than holding half of all vaccines produced to ensure administration of the second dose, only a portion would be held to cover for manufacturing or other problems.