Milan, May 4 beraking latest news Salute) – The EMA starts the evaluation process of a Chinese vaccine against Covid-19. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has started the rolling review process for the inactivated Vero Cell vaccine – which contains the killed Sars-CoV-2 coronavirus, therefore not capable of causing disease – developed by Sinovac Life Sciences Co. The EU applicant is Life’On Srl.
The CHMP’s decision to initiate the ongoing review procedure – in which product data is evaluated by the regulatory body as it becomes available – is based on preliminary results from 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 it becomes available to decide whether the benefits outweigh the risks,” a statement read. “The rolling review will continue until sufficient evidence is available to support a formal marketing authorization application” Aic, adds the regulatory authority. “Ema – he specifies – will assess the compliance of the inactivated Covid-19 (Vero Cell) vaccine with the usual EU standards” relating to “efficacy, safety and quality. Although Ema is unable 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.
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