EU regulators start the review of China's Sinovac vaccine: Details
European Union drug regulator announced on Tuesday that it has started a rolling review of China's Sinovac coronavirus vaccine to assess its effectiveness and safety, the 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.
No application seeking marketing authorization for Sinovac submitted yet
"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. The EMA, which so far has approved four coronavirus vaccines namely—Pfizer-BioNtech, Moderna, Oxford-AstraZeneca, and Johnson & Johnson, added that no application seeking marketing authorization for the Sinovac vaccine has been submitted yet.
Experts will evaluate data regarding the benefits of the vaccine
The agency said that its experts will evaluate 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 agency added.
WHO to take a decision on two Chinese COVID-19 vaccines
The announcement from the Amsterdam-based agency came a day after a top World Health Organization official said that the WHO is set to decide this week whether to approve two Chinese COVID-19 vaccines—Sinopharm and Sinovac for emergency use. Such approval would mark the first time that a Chinese vaccine had been granted a so-called emergency use listing from the UN health agency.
Approval would trigger a broader roll-out of Chinese vaccines
The approval would also trigger a broader roll-out of Chinese vaccines that are already being used in some countries beyond China. Mariangela Simao, Assistant Director-General for access to medicines, vaccines, and pharmaceuticals, says that some final arrangements remain to be made before the crucial word from a WHO technical advisory group comes on the Sinopharm and Sinovac vaccines.
Sinovac has supplied 260 million doses globally so far
Earlier in April, Sinovac's Chief Executive Yin Weidong told Reuters that the company has supplied 260 million doses of its vaccines globally. The countries which received the Sinovac vaccine are—Brazil, Indonesia, Nepal, Chile, and Turkey, amongst others.