Coronavirus vaccines are introduced in the EU through the marketing authorisation process
The EU Commission decides on the granting of a comprehensive EU marketing authorisation after receiving a positive recommendation from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use. The evaluation of the EMA centralised procedure includes several coronavirus vaccines, and the first that was authorised was the Pfizer-BioNTech vaccine on 21 December 2020.
EMA’s assesment on the evaluation of the Astra-Zeneca coronavirus vaccine
EMA is also currently evaluating the coronavirus vaccine developed by Astra-Zeneca and the University of Oxford in a so-called rolling submission procedure. Further information on extensive clinical trials in progress is expected in January and early next year.
EMA is aware of the decision taken by the pharmaceutical regulatory authorities in the UK (MHRA) to authorise the vaccine for temporary use due to the epidemic situation. The UK decision is not a marketing authorisation with comprehensive safety, efficacy and quality assessments, but a temporary authorisation granted in an emergency situation for the placing in service of a medicinal product, and it can also be removed in the event of a change in the situation or the emergence of new information.
While EMA will not compromise on the necessity of demonstrating the efficacy, safety and quality of the medicinal product during the assessment of coronavirus vaccines, it will improve the efficiency of the process by further resourcing and speeding up the process. New marketing authorisations for coronavirus vaccines are expected in early 2021.
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- Jukka Sallinen, tel. + 358 29 522 3410
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