EMA Confirms Fast-Track EUA-Style Review For Molnupiravir In COVID-19
Rolling Review Is Under Way But Could Take Some Time
The EU regulator says it is taking the emergency use route for molnupiravir because of the worrying rise in coronavirus infections and deaths.
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The European Medicines Agency’s advice that Lagevrio could be considered for emergency use still stands despite new data.
Coronavirus Notebook: Molnupiravir EU Approval Likely By Year End, Special CHMP Session Due On Comirnaty in 5 to 11-year-olds
The EMA is assessing the Janssen vaccine as a booster, and Switzerland is evaluating the use of the Pfizer/BioNTech and Moderna COVID-19 vaccines in younger age groups. The WHO has announced the first voluntary global license on a COVID-19 antibody detection technology.
Things are happening very quickly on the COVID-19 front, with sotrovimab, molnupiravir, Paxlovid and Novaxovid all under EU review for marketing authorization or emergency use, and EMA decisions expected on boosters and the use of vaccines in younger age groups.