Europe

The European regulator has questions about the quality of the AstraZeneca vaccine

The European Medicines Agency has asked for more information about a developed by Oxford University and the British-Swedish pharmaceutical company AstraZeneca.





This is stated in a press release from the regulator.

The agency is reviewing the data as part of a phased review. The latest set of such data related to clinical trials was received on December 21. At the same time, the press release notes that the company “was requested for additional scientific information related to the quality, safety, and efficacy of the vaccine, necessary for the issuance of an interim marketing authorization.”

In addition, EMA expects more information on ongoing clinical trials during the first quarter of 2021.

The agency is aware that the authorities have approved the use of this vaccine in the country. But this process has nothing to do with the issuance of an interim marketing authorization by the European regulator, which must ensure that the drug “meets the strictest standards for quality, efficacy, and safety.”

We will also remind, on December 27, AstraZeneca announced an increase in the effectiveness of its vaccine against .


Google News

Leave a Reply

Your email address will not be published. Required fields are marked *