The European Medicines Agency has begun an evaluation of China’s Sinovac vaccine, the drug regulator said on Tuesday. Preliminary data from laboratory studies show that the vaccine produces an immune response, the EMA said in a press release.
The “continuous review” process that the Sinovac vaccine will go through allows EU regulators to assess the data as they become available until there is sufficient evidence to submit a formal application for conditional marketing authorization.
The EMA did not specify a timeframe for a final decision, but said the process should “take less time than normal”.
The agency also has ongoing evaluations of three other vaccines, including the Sputnik vaccine, the CureVac mRNA vaccine and the Novavax protein vaccine. Sinovac vaccine uses an inactivated virus.
“The EMA will assess the vaccine’s compliance with standard EU standards for efficacy, safety and quality,” the EMA said.
Sinovac has shown different efficacy rates in studies conducted in several countries, ranging from 51% to 82%. It has been approved by Chinese regulators, along with three other domestic vaccines.
The World Health Organization is expected to make a decision on the vaccine later this week.
Source: Cotidianul RO by www.cotidianul.ro.
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