"Safety analysis through the January 22, 2021 data cutoff included 43,783 randomized (1:1) participants ≥18 years of age with 2-month median follow-up," the FDA briefing notes said. "The analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA."
"Non-fatal serious adverse events, excluding those attributed to COVID-19, were infrequent and balanced between study groups with respect to rates and types of events (0.4% in both groups)," the FDA added. "One serious event of a hypersensitivity reaction, not classified as anaphylaxis, beginning two days following vaccination was likely related to receipt of the vaccine."
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