US Officials Hope To Identify Correlates of Protection For COVID-19 Vaccines Shortly
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.
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Ability to bridge from adult effectiveness data to children in the absence of an identified correlate of protection could be affected by proposed dosing regimen and expected similarity in pediatric response, US FDA official says.