EU drugs watchdog receives Astra-Oxford vaccine approval application

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. Additional information was also provided by AstraZeneca at the request of CHMP and is currently being studied.

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. (https://bit.ly/2XuWmm3)

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.