EU regulator starts review of China’s Sinovac vaccine
- The EMA did not provide a time frame for its final decision, but it said the process should ‘take less time than normal’
Preliminary data from laboratory studies show that the jab produced an immune response, the EMA said in a press release.
The rolling review allows EU regulators to assess data as it becomes available until there is enough evidence to file a formal conditional marketing authorisation application.
The EMA did not provide a time frame for its final decision, but it said the process should “take less time than normal to evaluate ... because of the work done during the rolling review”. Its EU applicant, Life’On S.r.l., filed the application.
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The agency also has ongoing rolling reviews of three other vaccines, including Sputnik’s viral vector vaccine, CureVac’s mRNA vaccine and Novavax’s protein-based vaccine. Sinovac’s vaccine uses an inactivated virus that cannot cause the disease.