EU drugs watchdog receives Astra-Oxford vaccine approval application (Update)

The European medicines regulator said on Tuesday it had received an application from AstraZeneca for the conditional approval of the drugmaker’s COVID-19 vaccine being developed along with the University of Oxford.

The European Medicines Agency said it would assess the application under an accelerated timeline.

An opinion on the conditional marketing authorisation could be issued by Jan. 29 during the meeting of the European Medicines Agency’s (EMA) human medicines committee (CHMP), the EMA said in its statement.

The watchdog also said that during its rolling review of the vaccine, it had assessed data from ongoing trials in Britain, Brazil and South Africa. Additional information was also provided by AstraZeneca at the request of CHMP and is currently being studied.

Meanwhile the European Commission plans to conclude this week preliminary talks with French company Valneva over the advance purchase of its COVID-19 vaccine candidate, EU top negotiator Sandra Gallina told lawmakers on Tuesday.

“We intend to launch this week a tender procedure for Valneva,” Gallina said in a hearing in the EU Parliament, confirming a Reuters report from Monday.

She said the EU was also trying to conclude a supply deal with Novavax.

“We hope to be buying doses of Novavax,” she said. Preliminary talks with the U.S. vaccine makers were wrapped up on Dec. 17. for the supply of up to 200 million doses.