Pfizer COVID Vaccine Trial Proved Remote Monitoring, Other Innovations Work, ICON CEO Says
Steve Cutler, head of the CRO that conducted Pfizer’s study, tells the Pink Sheet that starting clinical trials in weeks, as opposed to months, should be possible post-pandemic.
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Plus deals involving Sanofi/SIRION, Merck KGAA/Day One, Beijing Tide/Graviton, Vaccinex/Surface Oncology, Athena/Tris, Biomunex/Onward, Cellectis/Cytovia
Pfizer moved aggressively and early as COVID-19 became a global health threat, and now the company, with its partner BioNTech, is the first to secure an emergency use authorization for a COVID vaccine from the US FDA.
Pfizer’s COVID Vaccine Raises No Safety Red Flags, But Managing Reactogenicity May Be Practical Challenge
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.