Last Minute Allocation Shake Up? Pfizer’s One-Dose Data Could Change COVID-19 Vaccine Rollout
New data released ahead of 10 December advisory committee is raising questions about whether the US government’s plan to hold back doses of Pfizer/BioNTech’s vaccine is the right move. Still, most experts don’t expect this to be a one-and-done vaccine. But testing the hypothesis might help the FDA solve its dilemma on when to vaccinate placebo patients.
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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.
Pfizer intends to notify placebo patients that an EUA has been issued and offer the vaccine to keep them in the study, but FDA appears to want to maintain placebo control for as long as possible.