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.
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Marketing applications for 10 new drugs have been added to the latest list of products under review by the European Medicines Agency.
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.
The French drug maker isn’t moving its mRNA COVID-19 vaccine into Phase III, instead focusing on a GSK-partnered protein SARS-CoV-2 vaccine and applying mRNA technology elsewhere.