The first step towards possible approval suggests that the shot builds resistance against the coronavirus after studies.
The European Union’s drug regulator has begun a rotation review of the COVID-19 vaccine, manufactured by the Chinese pharmaceutical company Sinovac, to evaluate its efficacy and safety, identifying it as the first step in its potential approval for use in the 227-nation block.
The European Medicines Agency (EMA) said on Thursday that the decision to launch the review was based on preliminary results from laboratory and clinical studies involving animals and humans, suggesting that the vaccine builds resistance against the coronavirus.
“These studies demonstrate that this vaccine triggers the production of antibodies … and can protect against this disease,” the agency said in a statement.
The Synovac vaccine contains an inactive or dead version of the SARS-Cavi-2 virus to help the human body produce antibodies to its immune system.
It has shown efficacy rates ranging from 50 percent to 90 percent in various studies.
The shot is currently approved for use in China, Indonesia, Brazil and Turkey.
In April, Sinovak said its third production center had doubled its annual capacity for the BRAC-coronavac vaccine in several regions.
The agency says more than 200 million doses of the Sinovac vaccine have been delivered worldwide.
Synovac is the first Chinese vaccine that EMA is studying in real time.
The company is conducting a revolving review of three more vaccines: a German biotech firm KuriVac, another US company NovaVax and a third – Russia’s Sputnik V.
Rolling reviews aim to speed up the approval process by allowing researchers to submit research in real time before final test data becomes available.
The company said its experts would evaluate the data to determine if the benefits of the Synovac shot were “greater than the risk”.
No Phase 3 study data on the vaccine has yet been published in the Peer-Review Journal.
The most closely monitored study involved about 12,000 health workers in Brazil, where researchers reported a 50.7 percent efficacy against the notable COID-19 and a much stronger defense against serious diseases.
The EMA’s rolling review will continue until “sufficient evidence is found to apply for a formal marketing approval”, the agency said, adding that it could not predict the deadline and that no such approval application had yet been submitted for the synovac vaccine.
The announcement from the Amsterdam-based agency comes a day after a top World Health Organization (WHO) official said the UN agency would decide this week whether to approve two Chinese COVID-19 vaccines for emergency use.
As a result of such approval, for the first time a so-called emergency vaccine was given to a Chinese vaccine by the UN health agency, and China will introduce a comprehensive rollout of vaccines already used in some countries outside of China.