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The European Union's pharmaceutical regulator began a rolling review of the COVID-19 vaccine produced by Chinese pharmaceutical company Sinovac to ascertain its effectiveness and safety in the first step towards its possible approval for use continent-wide
The European Medicines Agency (EMA) said that its decision to begin a review was based on preliminary results from laboratory and clinical studies, which suggest the vaccine produces an immune response against the coronavirus.
The agency said in a statement that "these studies suggest that the vaccine triggers the production of antibodies … and may help protect against the disease."
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The vaccine contains inactivated or dead versions of the SARS-CoV-2 virus to assist the body’s immune system produce antibodies.
It has shown efficacy rates of up to 90 percent in some studies and is currently authorized for use in China, Indonesia, Brazil, and Turkey.
In April, Sinovac announced its third production plant for its vaccine, branded CoronaVac in various regions, and was ready to double its annual production capacity to two billion doses.
The company said more than 200 million doses of Sinovac’s vaccine had been delivered globally.
Meanwhile, the EMA is also conducting rolling reviews of three other vaccines: the German CureVac, the US' Novavax, and Russia’s Sputnik V.
Europe's medicines regulator says it has begun a real-time review of Sinovac's COVID-19 vaccine. https://t.co/kvKXK81XJc
— euronews (@euronews) May 4, 2021
Rolling reviews are designed to expedite the approval process by allowing researchers to submit findings in real-time before final trial data become available.
The EMA said its experts would evaluate data “to decide if the benefits outweigh the risks” of the Sinovac vaccine.
The EMA’s rolling review will go on until “enough evidence is available for a formal marketing authorization application,” and the agency said that neither could it predict timelines nor that an application seeking authorization for the Sinovac vaccine had been submitted yet.
Just yesterday, 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 a Chinese vaccine would be granted such authorization from the UN health agency. It would also generate a broader rollout of Chinese vaccines that have already been used in many countries beyond China.
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