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Covid-19: EMA announces launch of continuous review of Chinese Sinovac vaccine


This procedure opens the way to a possible application for future authorization in the European Union. Four vaccines are currently in

The European Medicines Agency announced on Tuesday the launch of a “continuous review” procedure for the Chinese Sinovac vaccine against Covid-19.

This analysis paves the way for a possible application for future authorization in the European Union.

The decision of the Committee for Medicinal Products for Human Use of the EMA "to start the continuous review is based on preliminary results of laboratory studies (non-clinical data) and clinical studies", explains in a press release the European regulator based in Amsterdam.

Read also Covid-19: gray areas around vaccines produced in China

"These studies suggest that the vaccine triggers the production of antibodies that target Sars-CoV-2, the virus that causes Covid-19, and could help protect against the disease," adds the EMA.

100% effective in preventing deaths according to the laboratory

Already distributed in twenty countries, the CoronaVac from the Sinovac laboratory will be subject to review, "until sufficient evidence is available for an official marketing authorization application".

The EMA "will assess the data as soon as it becomes available to decide whether the benefits outweigh the risks," adds the text.

"The EMA cannot foresee an overall timetable but the assessment of a possible request should take less time than usual due to the work carried out during the continuous review", according to the agency.

Sinovac claims to have already delivered 200 million doses and to have received authorizations to market its product in more than thirty countries.

Also according to the laboratory, large-scale clinical trials in Brazil have shown an overall effectiveness rate of its Coronavac vaccine of around 50%, 80% against more serious forms and 100% in preventing death.

This vaccine uses the classic inactivated virus technique.

Currently, four vaccines are authorized in the EU: Pfizer-BioNTech, Moderna, AstraZeneca and Johnson & Johnson - the latter two under certain age conditions in most European countries.

Source: leparis

All life articles on 2021-05-04

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