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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
Potential Risk of Clinical Summary of Data/Rationale for Risk Mitigation Strategy
Significance
Study Procedures
Participants will be required to attend Without appropriate social distancing and Pfizer will work with sites to ensure an appropriate COVID-19 prevention
healthcare facilities during the global PPE, there is a potential for increased strategy. Potential COVID-19 illness visits can be conducted via telehealth,
SARS-CoV-2 pandemic. exposure to SARS-CoV-2. without the need for an in-person visit, if required, with the participant
performing a self-swab.
Venipuncture will be performed There is the risk of bleeding, bruising, Only appropriately qualified personnel would obtain the blood draw.
during the study. hematoma formation, and infection at the
venipuncture site.
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