EU regulator begins real-time review of first Chinese Covid-19 vaccine
Europe's medicines regulator
said on Tuesday it has started a real-time review of Sinovac's COVID-19
vaccine, based on preliminary results from animal and human trials that
suggested the vaccine produces an immune response against the coronavirus.
Data on the vaccine will be
assessed as they are made available to help speed up potential approvals, the
European Medicines Agency (EMA) said.
This is the first Chinese
vaccine the EMA is studying in real-time, and the fourth COVID-19 vaccine under
such a review, including those from CureVac, Novavax Inc and Russia's Sputnik
V.
Sinovac's vaccine has shown
efficacy rates between 50% and 90% in different studies and is currently
authorised for use in China, Indonesia, Brazil and Turkey.
The vaccine contains inactivated
or dead versions of the SARS-CoV-2 virus to help the human body's immune system
make antibodies.
In early April, Sinovac said its
third production plant for its vaccine, branded CoronaVac in some regions, was
ready, doubling its annual capacity to 2 billion doses. The firm said more than
200 million doses of Sinovac's vaccine have been delivered globally.
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.