The first validated component comes after research says that the shot releases the immune system against the coronavirus.
A European Union pharmaceutical company has begun a review of the COVID-19 vaccine developed by the Chinese company Sinovac to monitor its effectiveness and safety, and indicate the first phase to be approved for use in 27 countries.
The European Medicines Agency (EMA) said Thursday that its decision to re-evaluate was based on preliminary results from laboratory and clinical, animal and human studies, indicating that the vaccine produces antibodies against coronavirus.
“This study shows that the vaccine triggers the production of antibodies … and can help protect against the disease,” the agency said in a statement.
The Sinovac vaccine contains inactive or dead SARS-CoV-2 viruses to help the human immune system make antibodies.
It will also show an increase in activity between 50 percent and 90% in various studies.
The shot is approved for use in China, Indonesia, Brazil and Turkey.
In April, Sinovac said its third vaccine plant, CoronaVac in some areas, was ready, doubling its annual value by 2 billion units.
The company said more than 200 million Sinovac vaccines have been distributed worldwide.
Sinovac is the first Chinese vaccine that EMA is studying in real time.
The commission is also considering three other vaccines: one developed by the German company CureVac, another by the US company Novavax, and a third – Sputnik V.
Rolling comments are intended to speed up the process of retrieval by allowing researchers to present their findings in real time.
The agency said its experts would look into more “to see if the benefits outweigh the risks” of Sinovac’s shooting.
No Phase 3 study section on the vaccine has been reprinted in peer-reviewed journals.
The most closely monitored study affected approximately 12,000 health care workers in Brazil, where researchers reported that 50.7% were effective against COVID-19 and strong immunity to chronic diseases.
The EMA review will continue until “there is sufficient evidence to permit advertising”, the agency said, adding that it did not specify the time and that no request for approval for the Sinovac vaccine has yet to be submitted.
The announcement from Amsterdam came a day after the World Health Organization (WHO) said the United Nations should decide this week to approve two Chinese vaccines for COVID-19 for emergency use.
Such approval would be the first time that a Chinese vaccine would be named after a UN official, and it could result in a large number of Chinese vaccines already in use in other countries far from China.