EU Renews Moderna’s Spikevax Approval, Clarifies Stance On Comirnaty Booster
The European Medicines Agency has explained the grounds for its decision to recommend an extension of the approval for Moderna’s coronavirus vaccine, and why it differed from the US FDA in its advice on a booster dose of the Pfizer/BioNTech product.
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Coronavirus Notebook: Sanofi Under Pressure To Hand mRNA Vaccine To Africa, EMA OKs Booster Dose For Comirnaty
The European Medicines Agency says there is a possible link between the Janssen vaccine and rare cases of venous thromboembolism, and that immune thrombocytopenia should be added as an adverse reaction to the Janssen and AstraZeneca vaccines. The agency has also begun evaluating a marketing authorization application for Celltrion’s regdanvimab in COVID-19 patients.
One Down, Two To Go: Pfizer/BioNTech Booster Decision Creates Pressure For More Extra Shot Authorizations
Inequity created by limiting the mRNA vaccine’s third dose to only those individuals who received a primary series of the same vaccine, as well as resulting operational complexities, warrant consideration of a mix-and-match approach with Moderna and J&J products, CDC advisors say; however, FDA appears most focused on vetting manufacturer-specific data on homologous boosting.
Age limit wasn’t part of advisory committee’s vote on third shot of the COVID vaccine, but aligns with concerns about myocarditis in younger recipients.