EMA Assessing Moderna’s Spikevax Against COVID-19 In 6-11 Year-Olds
Phase II Study Showed A ‘Robust’ Response
Moderna says this is the first filing for the vaccine in this age group, and that it will be followed by submissions to other world regulators.
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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.
New EU guidance will cover non-clinical and clinical development, trial design, endpoints, safety issues and comparators, as well as the use of immunobridging studies.