PHARMACEUTICAL GIANT NOVAVAX has applied for authorisation for their coronavirus vaccine in the European Union with a decision possible “within weeks”, Europe’s drugs regulator said today.
The jab, if approved, would be the fifth authorised for use within the EU – the other four are made by BioNTech/Pfizer, AstraZeneca, Moderna and Johnson & Johnson.
The vaccine’s assessment, which goes under the brand name Nuvaxovid, would be carried out “under an accelerated timeline”, the European Medicines Agency said.
An opinion on the marketing authorisation could be issued within weeks “if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the vaccine”, the medicines watchdog said.
“If EMA concludes that the benefits of Nuvaxovid outweigh its risks in protecting against Covid-19, it will recommend granting a conditional marketing authorisation,” it said.
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