The European Medicines Agency announced this Tuesday that it has already received the application for conditional approval of the Covid-19 vaccine developed by the University of Oxford and AstraZeneca, and their decision could be issued by 29th January.
1. Accelerated assessment
The EMA has received the application for conditional marketing authorisation (CMA) for the the vaccine, known as COVID-19 Vaccine AstraZeneca, and plans to complete its assessment with an accelerated timeline, with the decision on the vaccine possibly being issued by 29th January. However this is provided that the data submitted on the quality, safety and efficacy of the vaccine is sufficiently robust and complete, and any additional information required to complete the assessment must also be promptly submitted.
This accelerated assessment is possible because EMA has already reviewed some data on the vaccine during a rolling review, in which it assessed data from laboratory studies, data on the vaccine’s quality (its ingredients and how it is made), and some evidence on its safety and efficacy from an analysis of interim clinical data from four ongoing clinical trials in the United Kingdom, Brazil and South Africa. Additional scientific information on issues related to quality, safety and efficacy of the vaccine was also provided by the company at the request of CHMP (Committee for Medicinal Products for Human Use), and is currently being assessed.
2. Conditional marketing authorisation
According to EU legislation, CMA is the fast-track authorisation procedure used to speed up the approval of treatments and vaccines during public health emergencies, such as the current Covid-19 pandemic, to fulfil a medical need using less complete data than is usually required. This is used when the benefit of a medicine or vaccine’s immediate availability to the population outweighs the risks caused by not all the data being available yet. A CMA guarantees that the approved medicine/vaccine meets rigorous EU standards for safety, efficacy and quality, and is manufactured and controlled in approved, certified facilities in line with high pharmaceutical standards compatible with large-scale commercialisation. Once a CMA is granted, companies must also provide further data from ongoing or new studies within pre-defined deadlines in order to confirm that its benefits continue to outweigh the risks.
3. Next steps
If the EMA concludes that the benefits of the COVID-19 Vaccine AstraZeneca outweigh its risks in protecting against COVID‑19, it will recommend granting a CMA, and once this is granted the European Commission will then fast-track its decision-making process with a view to granting a CMA, which will be valid in all EU and EEA Member States within days.