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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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.
Instead of celebrating the EUA for Pfizer/BioNTech’s COVID vaccine, officials at FDA and Operation Warp Speed once again have to answer questions about President Trump’s apparent interference in the process. But while Joe Biden isn't likely to rage-tweet about the agency, the incoming administration so far hasn't shown that much respect or understanding of FDA processes either.