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. 

New data released ahead of 10 December advisory committee is raising questions about whether the US government’s plan to hold back doses of Pfizer/BioNTech’s vaccine is the right move. Still, most experts don’t expect this to be a one-and-done vaccine. But testing the hypothesis might help the FDA solve its dilemma on when to vaccinate placebo patients.

New data released ahead of 10 December advisory committee is raising questions about whether the US government’s plan to hold back doses of Pfizer/BioNTech’s vaccine is the right move. Still, most experts don’t expect this to be a one-and-done vaccine. But testing the hypothesis might help FDA solve its dilemma on when to vaccinate placebo patients.