EU regulator starts review of China’s Sinovac vaccine

The European Medicines Agency has begun a rolling review of China’s Sinovac coronavirus vaccine, the drugs regulator announced Tuesday.

Preliminary data from lab studies show that the jab produces an immune response, the EMA wrote in a press release.

The rolling review allows EU regulators to assess data as it becomes available until there’s enough evidence to file a formal conditional marketing authorization application.

The EMA didn’t 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.

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.

“EMA will assess the compliance of [the vaccine] with the usual EU standards for effectiveness, safety and quality,” the EMA wrote.

Sinovac has posted differing efficacy rates in various real-world studies that range between 51 and 82 percent. It has been approved by Chinese regulators, along with three other homegrown vaccines, but they have mostly posted relatively low efficacy rates compared to their Western counterparts.

The World Health Organization is expected to make a decision about the vaccine at the end of this week.

This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email for a complimentary trial.
Read More