EMA Agrees Monovalent XBB Vaccines Best For Coming COVID-19 Campaigns
The European Medicines Agency says it is talking with international partners and pharmaceutical companies about the epidemiological situation with SARS-CoV-2 and how authorized COVID-19 vaccines can best be adapted to emerging variants.
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The European Medicines Agency’s CHMP was set to adopt opinions on SK Bioscience’s COVID-19 vaccine and Mycovia/Gedeon’s Vivjoa for vulvovaginal candidiasis during its September meeting, but both marketing authorization filings were voluntarily withdrawn.
During the pandemic, the EU drugs regulator became more flexible and agile and went beyond the formal boundaries of its mandate, says its executive director Emer Cooke, who also warns of the need for the agency to retain the trust of the public.
A workshop led by the European Medicines Agency and the US Food and Drug Administration sought to reach alignment on adapting COVID-19 vaccines to emerging virus variants.