EU Regulator Eyes Mid-September For Decision On Comirnaty BA.4/BA.5 Booster Approval
Agency Also Expects Adapted Spikevax Filing From Moderna This Month
As regulators continue to process and approve applications for new kinds of COVID-19 booster vaccines, evidence is still awaited on the real-world benefits conferred by the latest variant-adapted products. The European Medicines Agency and the European Centre for Disease Prevention and Control plan to issue a joint statement on the use of adapted vaccines next week, and the EMA has OKd a booster version of the Novavax vaccine.
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Coronavirus Notebook: UK OKs Second Bivalent Vaccine, European Companies Warn On Joint Vaccine Procurement Plans
The Swiss medicines regulator has approved the bivalent version of Spikevax and given the green light to use of the Novavax COVID-19 vaccine in younger people.
The European Commission will shortly issue marketing authorizations for bivalent versions of Comirnaty and Spikevax targeting the Omicron BA.1 subvariant, after the European Medicines Agency recommended their approval for EU-wide use. Bivalent Spikevax has also been provisionally approved in Australia.
Regulatory bodies from Australia, Canada and the UK say a new pilot program will reduce the need for multiple inspections of the same site, while an MoU signed by Australia and Canada will cut the amount of documentary evidence required from drug sponsors seeking GMP clearances.