CBER Will Need About A Week To Complete COVID Vaccine Assessment Following Advisory Cmte., Marks Says
Timeline is the most pessimistic public projection to date, but still incredibly fast. Clinical trial patients on placebo could be contacted and offered the vaccine after an EUA is granted.
You may also be interested in...
Only vaccinating the placebo group would be much easier once the US FDA grants an EUA for its coronavirus vaccine, Pfizer says.
The allergic reactions ‘just occurred yesterday and they haven’t been fully investigated,’ CBER Director Marks says.
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.