EMA starts a rolling review of Sinovac's COVID-19 vaccine

The agency’s human medicines committee (CHMP) started a rolling review of China’s Sinovac Covid-19 vaccine.

“The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and clinical studies. These studies suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease,” the medicines regulator said in a statement.

“EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for a formal marketing authorization application.”

!! EMA human medicines committee (#CHMP) has started a rolling review of #COVID19vaccine (Vero Cell) Inactivated, developed by Sinovac Life Sciences Co., Ltd.

Link to the announcement ?https://t.co/DK7qcNGLbu pic.twitter.com/fsq6TNVzjF

— EU Medicines Agency (@EMA_News) May 4, 2021

“EMA will assess the compliance of COVID-19 Vaccine (Vero Cell) Inactivated with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review,” EMA stated.

“EMA will communicate further when the marketing authorization application for the vaccine has been submitted,” it added.

The EMA has already approved the Pfizer, Moderna, AstraZeneca, and Johnson & Johnson jab, and three other vaccines are already in the EMA’s rolling review process — CureVac, Novavax, and Russia’s Sputnik V vaccine. (ILKHA)