GSK/Vir’s Xevudy Begins EU Review For COVID-19
EMA Issues Scientific Opinion On Molnupiravir
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.
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Coronavirus Update: Pfizer/BioNTech Vaccine Effective Against Omicron
Also, AstraZeneca scores an emergency use authorization from the FDA for its COVID-19 PrEP antibody Evusheld, while Merck files for Japanese approval of molnupiravir.
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.
Novavax COVID-19 Vaccine Could Get EU Approval ‘In Weeks’
Having completed a rolling review, the vaccine is now being evaluated by the European Medicines Agency for conditional marketing authorization under an accelerated timeline.