Placebo-Unblinding Should Be Uniform Across COVID Vaccine Trials, Advisory Committee Says
US FDA’s outside advisors say Moderna should offer vaccine to placebo-arm patients when they are eligible, the same plan adopted for the Pfizer/BioNTech COVID-19 vaccine.
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Pfizer relies on investigators to determine when prioritization recommendations apply, Moderna offers unblinding to everyone.
US FDA’s global first for Moderna’s vaccine gets a small mention as agency looks to pharmacovigilance, follow-up studies for both coronavirus inoculations that have now been authorized. Moderna's 18 December EUA comes after an even faster review than for Pfizer/BioNTech's vaccine.
Moderna’s COVID-19 vaccine got a more solid ‘yes’ vote than Pfizer/BioNTech’s, but committee chair cautions against drawing any comparisons between the products from the different tallies. Last-minute bickering over FDA’s phrasing of voting question complicated meeting but resulted in minimal harm.