Sunday, 9 May 2021

EMA opens review of China's Sinovac coronavirus jab

THE HAGUE (AFP) – The European Medicines Agency said on Tuesday (May 4) it has started a “rolling review” of China’s Sinovac coronavirus jab, a process that could lead to eventual approval for the European market.

Made by Sinovac’s Beijing-based Life Sciences unit, the vaccine contains an inactivated coronavirus that cannot cause a disease, but helps a person to develop antibodies against the virus.

The EMA’s human medicines committee’s “decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and clinical studies,” the Amsterdam-based agency said.

“These studies suggest that the vaccine triggers the production of antibodies that target Sars-CoV-2, the virus that causes Covid-19, and may help protect against the disease,” it said in a statement.

The EMA will now continue the review until there is enough information for the company to make a formal application for it to be released to the market.

“While the EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review,” it said.

Sinovac’s shot was approved by China’s medicines regulator for use in February.

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