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.


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