Pandemic Logistics: US FDA Has Not Verified Some Moderna COVID-19 Vaccine Data And Analyses
Older patients appear to have lower efficacy in a Moderna application amendment that the agency hasn’t fully digested, but along with the original submission, data still supports evaluation for an emergency use authorization, the FDA said.
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As FDA Advisers Grow Comfortable With EUAs, Harder Decisions On J&J’s Vaccine Fall To States, Individuals
J&J’s COVID-19 vaccine sails through its US FDA advisory panel, but that just means the subpopulation efficacy questions need to be wrestled with by other public health space, as CDC and the states must figure out the best way to distribute multiple vaccines with differing efficacy profiles, regimens and storage requirements.
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 looks better than Pfizer/BioNTech’s at preventing severe disease and like it may offer some benefit in preventing asymptomatic infections, but these advantages may be short-lived and hard to capitalize on due to supply limitations.