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The European Medicines Agency (EMA) has requested additional information from the pharmaceutical company AstraZeneca about its corona vaccine, which has already been approved in the UK. The agency received the latest package of clinical data on Dec. 21 and is currently under evaluation, the EMA reported Wednesday. For a conditional approval of the vaccine in the European Union, more information on its quality, safety and efficacy is necessary.
US targets April for approval
These were requested from the company. Also, more information is expected from ongoing clinical studies in January. Interim data from a large study in the US is expected in the first quarter of 2021. A spokesperson for AstraZeneca said the group had submitted a full data package to the EMA. In the US, if all goes well, the vaccine is expected to receive emergency approval sometime in April, said Moncef Slaoui, head of Operation Warp Speed, which is pushing and overseeing development of the vaccine in the US. USA
So far, only the crown vaccine from Biontech and Pfizer has been approved in the EU. On Tuesday, EMA deputy director Noel Wathion stated that approval of the AstraZeneca vaccine in January was unlikely. AstraZeneca’s vaccine is cheaper to manufacture and easier to store than Pfizer / Biontech and Moderna drugs.
