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.
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Placebo Unblinding Process For Pfizer’s COVID Vaccine No Detriment To US FDA Safety Analysis
Despite initial concerns among FDA staff and its advisory committee about unblinding the Comirnaty pivotal trial after emergency authorization, agency’s review of the first COVID vaccine to receive full licensure suggests its safety conclusions were not adversely affected.
Permanent Vaccine Facility Should Be On Standby For Future Pandemics, Moncef Slaoui Says
Operation Warp Speed confirmed the necessity of having a facility on hand to develop and manufacture a vaccine for the next crisis, the outgoing advisor says.
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.