Placebo-Control Strategy After EUA Remains Big Question For Pfizer/BioNTech COVID-19 Vaccine
Executive Summary
Pfizer intends to notify placebo patients that an EUA has been issued and offer the vaccine to keep them in the study, but FDA appears to want to maintain placebo control for as long as possible.
You may also be interested in...
Pfizer Doesn’t Like Crossover Design For Placebo Patients In COVID-19 Vaccine Trial
Only vaccinating the placebo group would be much easier once the US FDA grants an EUA for its coronavirus vaccine, Pfizer says.
Last Minute Allocation Shake Up? Pfizer’s One-Dose Data Could Change COVID-19 Vaccine Rollout
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.
Last Minute Allocation Shake Up? Pfizer’s One-Dose Data Could Change COVID-19 Vaccine Rollout
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.