Last minute: European Medicines Agency launches Chinese vaccine pre-assessment process

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The European Union (EU) medicines regulator, the European Medicines Agency (EMA), has launched the process of pre-evaluation of the vaccine developed by the Chinese company Sinovac against the new type of coronavirus (Kovid-19) and used in Turkey.

In the EMA statement, it was stated that the decision to start the pre-evaluation of the “inactive Kovid-19 vaccine (Vero Cell)” had been taken on the basis of the initial results obtained from laboratory studies. and clinical studies. In the first results, the vaccine was reported to produce antibodies against the virus that causes Kovid-19 disease.

The agency will continue its assessment as data on the vaccine becomes available. The evaluation process will continue until sufficient evidence is obtained for the formal application for approval of the vaccine for use in the EU. In this process, it will be assessed whether the vaccine meets EU standards in terms of efficacy, safety and quality.

EMA officials did not provide information on the duration of the assessment. However, thanks to the pre-assessment process, the EMA can make decisions in a much shorter time frame than usual when the company applies for marketing approval.

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After successfully passing the pre-evaluation process for previously approved vaccines, the vaccines that EMA is currently pre-evaluating are Curevac, Novavax, Sputnik V.

The vaccine from Chinese company Sinovac was added to these.

Previously, the BioNTech-Pfizer, AstraZeneca, Moderna and Johnson and Johnson vaccines were approved for use in the EU.

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