1. Pink Sheet

Pfizer’s COVID Vaccine Raises No Safety Red Flags, But Managing Reactogenicity May Be Practical Challenge

 
• By Sue Sutter

Phase III data show no specific safety concerns that would preclude issuance of an EUA, US FDA says in advisory committee briefing document; however, high rate of local injection site and systemic adverse events could complicate compliance with 21-day, two-dose regimen.

Senior citizen couple taking a walk in a park during autumn morning.
Injection site and systemic reactions with Pfizer's COVID-19 vaccine will be no walk in the park. • Source: Shutterstock

Adverse events reported in the Phase III study for Pfizer Inc./BioNTech SE’s COVID-19 vaccine do not appear to preclude an emergency use authorization at this point in time, based upon US Food and Drug Administration review documents.

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