Coronavirus Update: EMA To Update Comirnaty And Spikevax Labels On Cardiac Safety
Plus, New REGEN-COV Filing And Novel Vaccine Progress
Comirnaty and Spikevax to get EU label update on cardiac safety, Japanese filing for REGEN-COV, plus vaccine progress for ReiThera and Genexine.
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Japan has granted an emergency approval to Chugai/Roche/Regeneron's antibody cocktail after a rapid review, while India has emerged as one of the top purchasers globally of COVID-19 vaccines as it looks to protect more of its population.
US FDA will rapidly update fact sheets with information on myocarditis/pericarditis occurring primarily in young men and adolescent males following the second dose, agency's Doran Fink tells the CDC’s Advisory Committee on Immunization Practices, which said benefit-risk of the Pfizer/BioNTech and Moderna vaccines remains favorable.
Identifying patients who have not mounted an immune response to SARS-CoV2 and treating them with the antibody cocktail cuts risk of death by a fifth.