Possibility Of COVID Vaccine Production Glitches Drives Early US Dose Distribution Plan
Initial allocation plans for the Pfizer/BioNTech vaccine may change after a month or so if manufacturing scaleup proceeds ‘perfectly,’ Operation Warp Speed’s Slaoui suggests.
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Donald Trump is no longer the only one who thinks the US FDA is moving too slow on allowing broad access to COVID-19 vaccine candidates. But before the narrative that FDA’s caution cost lives takes root, let’s remember the facts: the key milestone isn’t when an effective vaccine is authorized, but when supplies are sufficient to mount an effective vaccination campaign.
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.
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 FDA solve its dilemma on when to vaccinate placebo patients.