Covid vaccine, Novavax asks for ok Ema: when it arrives in Italy

The Novavax vaccine against covid could arrive, even in Italy, within a few weeks. Today, the European medicines agency EMA received the conditional marketing authorization application for the vaccine and began evaluating the application. The vaccine contains tiny particles made up of a version of the protein found on the surface of SARS-CoV-2 (the S spike protein), which was made in the laboratory. It also contains an “adjuvant”, a substance that helps strengthen immune responses. The process, the EU regulatory body communicates in a note, “will proceed with accelerated times and an opinion on the authorization could be issued within weeks if the data presented are sufficiently robust and complete to demonstrate the efficacy, safety and quality of the vaccine “. “Such a short period of time – the EMA points out – is only possible because a substantial part of the data” on the Nuvaxovid vaccine (also known as Nvx-CoV2373) “has already been examined during the review. human use Chmp Ema evaluated data from laboratory studies (non-clinical), some information on the quality of the vaccine and how it will be produced and data on its safety, immunogenicity (how well it triggers a response against the virus) and efficacy against Covid from clinical trials in adults “. In parallel, the Prac safety committee of the EU body completed the preliminary assessment of the risk management plan proposed by the company, which outlines the measures to identify, characterize and minimize the risks of the drug. In addition, the Committee for Medicinal Products for Children (PDCO) issued its opinion on the company’s pediatric investigation plan (PIP), which describes how the medicine should be developed and studied for use in children. If the EMA concludes that the benefits of Nuvaxovid outweigh the risks in protecting against Covid, it will recommend granting conditional clearance. The European Commission will therefore speed up the decision-making process in order to grant it within a few days and it will be valid in all EU Member States and the European Economic Area.