The European Union’s medicines regulator has started a rolling review of the COVID-19 vaccine produced by Chinese pharmaceutical company Sinovac to assess its effectiveness and safety, marking the first step towards its possible approval for use in the 27-nation bloc.
The European Medicines Agency (EMA) said on Thursday that its decision to start the review was based on preliminary results from laboratory and clinical studies, involving animals and humans, which suggest the vaccine produces an immune response against the coronavirus.
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“These studies suggest that the vaccine triggers the production of antibodies … and may help protect against the disease,” the agency said in a statement.
Sinovac’s vaccine contains inactivated or dead versions of the SARS-CoV-2 virus to help the human body’s immune system make antibodies.
It has shown efficacy rates between 50 percent and 90 percent in different studies.
The shot is currently authorised for use in China, Indonesia, Brazil and Turkey.
In April, Sinovac said its third production plant for its vaccine, branded CoronaVac in some regions, was ready, doubling its annual capacity to two billion doses.
The company said more than 200 million doses of Sinovac’s vaccine have been delivered globally.
Sinovac is the first Chinese vaccine the EMA is studying in real time.
The agency is also conducting rolling reviews of three other vaccines: one developed by German biotech firm CureVac, another by the US company Novavax, and a third – Russia’s Sputnik V.
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 agency said its experts will evaluate data “to decide if the benefits outweigh the risks” of the Sinovac shot.
No Phase 3 study data on the vaccine has yet been published in peer-reviewed journals.
The most closely watched research involved about 12,000 health workers in Brazil, where researchers reported 50.7 percent effectiveness against symptomatic COVID-19 and much stronger protection against severe disease.
The EMA’s rolling review will continue until “enough evidence is available for a formal marketing authorisation application”, the agency said, adding that it could not predict timelines and that no application seeking such authorisation for the Sinovac vaccine has been submitted yet.
The announcement from the Amsterdam-based agency came a day after a top World Health Organization (WHO) official said the United Nations body 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 a so-called emergency use listing from the UN health agency, and would trigger a broader rollout of Chinese vaccines that are already being used in some countries beyond China.