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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