The Pfizer Effect: Moderna Tries To Escape Big Pharma’s Shadow At US FDA Vaccines Panel
Sponsor and agency sought to proactively address questions about the potential for anaphylactic reactions with the COVID-19 vaccine given the early real-world experience with Pfizer’s inoculation, which is also uses mRNA technology.
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The FDA granted emergency authorization for Moderna's mRNA-1273 following a 17 December advisory committee vote in its favor. There have also been more supply deals and approvals in Asia.
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.
Agency could revisit contraindications and warnings regarding allergic reactions and anaphylaxis management depending upon what it hears from the MHRA; FDA and Pfizer say there was no signal for severe allergic reactions in the Phase III trial, but advisory committee member Paul Offit suggests a dedicated study is needed.