EU regulators start review of China's Sinovac vaccine

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The European Union's drug regulator has started a rolling review of China's Sinovac coronavirus vaccine, a first step toward possible approval for use in the 27-nation bloc.
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The European Union’s drug regulator said that it has started a rolling review of China’s Sinovac coronavirus vaccine to assess its effectiveness and safety, a first step toward possible approval for use in the 27-nation bloc.

The European Medicines Agency said on Tuesday that its decision to start the review is based on preliminary results from laboratory studies and clinical studies.

“These studies suggest that the vaccine triggers the production of antibodies” that fight the coronavirus “and may help protect against the disease,” the agency said in a statement.

Rolling reviews are aimed at speeding up the approval process by allowing researchers to submit findings in real-time before final trial data is available.

The EMA, which so far has approved four coronavirus vaccines, added that no application seeking marketing authorization for the Sinovac vaccine has been submitted yet. The agency is also conducting rolling reviews of three other vaccines: the one developed by German biotech company CureVac, the American-developed Novavax and Russia’s Sputnik V. The agency said its experts will “valuate data as they become available to decide if the benefits outweigh the risks” of the vaccine. The rolling review will continue until “enough evidence is available for a formal marketing authorization application,” the EMA said.

The announcement from the Amsterdam-based agency came a day after a top World Health Organization official said the WHO is set to decide this week whether to approve two Chinese COVID-19 vaccines for emergency use.

Such approval would mark the first time that a Chinese vaccine had been granted an emergency use listing from the UN health agency, and would trigger a broader rollout of Chinese vaccines that are being used in some countries beyond China.

Mariangela Simao, assistant director-general for access to medicines, vaccines and pharmaceuticals, says some “final arrangements” remain to be made before the crucial word from a WHO technical advisory group comes on the Sinopharm and Sinovac vaccines.

China and some other countries, including Brazil, Mexico, Indonesia and Turkey, are already using the Sinovac vaccine, which contains inactivated or dead versions of the SARS-CoV-2 virus to help the human body’s immune system make antibodies.

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