Coronavirus Notebook: Adapted Comirnaty Vaccine Under EU Review, Sanofi & GSK Laud Next-Gen Booster
Valneva expects its vaccine candidate to be approved this month. Meanwhile, the core functions of the UK’s Vaccine Taskforce are to be transferred to the UK Health Security Agency and the Office for Life Sciences.
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Coronavirus Notebook: UK Supplying Bivalent Spikevax Via Special Mechanism, Next-Generation BA.4/BA.5 Vaccines Filed In EU
The European Medicines Agency could make an EU approval recommendation on two bivalent Omicron BA.1-targeting vaccines on 1 September.
The European Medicines Agency says regulators are currently discussing the extent to which clinical data will have to be submitted to support the approval of an adapted vaccine against Omicron variants.
Will BioMarin be second time lucky with its hemophilia gene therapy Roctavian in the EU? The European Medicines Agency could soon decide whether the product should be approved.