EMA starts rolling review of China’s Sinovac Covid vaccine

Evidence will be scrutinised in real time as it emerges from animal and human trials

The rolling reviews will continue until enough evidence is available for the vaccine manufacturers to make a formal application for conditional marketing authorisation. Photograph: iStock

The rolling reviews will continue until enough evidence is available for the vaccine manufacturers to make a formal application for conditional marketing authorisation. Photograph: iStock

 

The European Medicines Agency has begun a rolling review of evidence of the safety and efficacy of China’s Sinovac Covid-19 vaccine, after studies suggested it produces an immune response.

It means that evidence will be scrutinised in real time as it emerges from animal and human trials, a process designed to ensure that the vaccine can be approved as quickly as possible if it proves to be effective.

“EMA will evaluate data as they become available to decide if the benefits outweigh the risks,” the medicines regulator said in a statement.

Three other vaccines are already in the EMA’s rolling review process — CureVac, Novavax and Russia’s Sputnik V vaccine — while the EMA previously conducted rolling reviews on the four vaccines from Pfizer, Moderna, AstraZeneca, and Johnson & Johnson that have since been approved.

Rolling reviews continue until enough evidence is available for the vaccine manufacturers to make a formal application for conditional marketing authorisation.

The Sinovac vaccine contains inactivated Covid-19 virus that cannot cause the disease, along with an “adjuvant”, a substance that helps strengthen the body’s immune response.

The vaccine is intended to work by provoking an immune response, as the body identifies the inactivated virus and creates antibodies to combat it. The immune system is then ready to recognise Covid-19 and defend the body against it if it later encounters the virus.

Different studies have shown efficacy rates of between 50 per cent and 90 per cent for the Sinovac vaccine, which is currently authorised for use in China, Brazil, Egypt, Indonesia, and Turkey.

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. – Additional reporting, Reuters