Wednesday, August 25, 2021

Has This Safety Monitoring Been Done? If So, What Were The Results?

FDA  | From Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum  - Page 44


5.2. Pharmacovigilance Activities
Pfizer submitted a Pharmacovigilance Plan (PVP) to monitor safety concerns that could be associated with Pfizer-BioNTech COVID-19 Vaccine. The Sponsor identified vaccine-associated enhanced disease including vaccine-associated enhanced respiratory disease as an important potential risk.


0 comments:

Do What I Do - ENJOY THE CHASE - And Stay Amused....,

  "Many years ago I was convinced the Heisenberg uncertainty principle was incomplete, and people shouldn't just believe it becaus...