Wednesday morning around 9 a.m., the FDA reported the detailed case of Pfizer to the agency and its external advisors to authorize the booster doses of Covid-19. Three hours later, the FDA released its own analysis.
For most documents, it’s as if the agency and the company are having two different conversations.
The documents provide a prelude to an advisory committee hearing that will discuss whether the agency should approve the reinforcement shots. The issue has proven to be deeply polarizing. President Biden has pledged to authorize data-driven proponents in Israel and elsewhere, angering some public health officials inside and outside the FDA, who fear the president will interfere with the agency’s independence and they argue that existing data do not support these traits, especially when much of the world remains unvaccinated.
Continue reading the endpoints with a free subscription
Unlock this story instantly and join over 117,400 biopharma professionals by reading Endpoints daily, and it’s free.