• Tue. Oct 26th, 2021

Covid, Ema starts review of Chinese Sinovac vaccine


May 4, 2021

Ema starts the evaluation process of the Chinese vaccine against Covid-19 Vero Cell, developed by Sinovac Life Sciences. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has started the rolling review process for the inactivated vaccine, which contains the coronavirus that cannot cause disease. The EU applicant is Life’On Srl. The decision of the CHMP to initiate the continuous review procedure – in which the data on the product is evaluated by the regulatory body as it becomes available – is based on the preliminary results of studies of laboratory (preclinical) and clinical studies. “These studies suggest that the vaccine triggers the production of antibodies targeted against Sars-CoV-2 – explains the EMA – and can help protect against the disease.” “The EMA will evaluate the data as they become available to decide whether the benefits outweigh the risks “, reads a note. “The rolling review will continue until sufficient evidence is available to support a formal marketing authorization application” Aic, adds the regulatory authority. “The Ema – he specifies – will assess the compliance of the inactivated Covid-19 vaccine (Vero Cell) with the usual EU standards” relating to “efficacy, safety and quality. Although Ema is not able to predict the general timing”, the rolling review process “should take less time than normal”, reminds the body that will communicate when the Aic for the vaccine will be presented. The product, based on the inactivated Sars-CoV-2 coronavirus, also contains an adjuvant, which is a substance that helps strengthen the immune response induced by the vaccine.