Coronavirus: EMA Receives Application for CMA of COVID-19 Vaccine AstraZeneca
15 gennaio 2021 – On 12 January 2021, the EMA has announced that it has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. CMAs allow for the authorisation of medicines that fulfil an unmet medical need on the basis of less complete data than normally required. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January, provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete and that any additional information required to complete the assessment is promptly submitted. If EMA concludes that the benefits of the vaccine outweigh its risks in protecting against COVID 19, it will recommend granting a conditional marketing authorisation. The European Commission will then fast-track its decision-making process with a view to granting a conditional marketing authorisation valid in all EU and EEA Member States within days.
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