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August 26, 2021 "At this stage it has not yet been determined when a booster dose for Covid vaccines may be needed and for which population groups", but the EU is already working with Member States and producers to speed up procedures in case of need.
This was clarified by the European Medicines Agency (Ema) by answering ANSA's questions on the "third dose".
Final reports on clinical trials of Pfizer-BioNtech (Comirnaty) vaccine are expected to be submitted in December 2023, enabling EU authorization to be transformed from conditional to standard. This was clarified by the European Medicines Agency (EMA) by answering ANSA's questions, after the full approval of the Pfizer / BioNtech vaccine by the US authorities. But, the Amsterdam-based agency underline, "compared to the emergency use approvals that other regions of the world have used, Covid-19 vaccines have received marketing authorization from the beginning in the EU" , even if conditioned to "specific obligations". In this way, the green light could be "valid in all Member States at the same time".The authorizations granted to the four vaccines approved by the EU, the EMA explain, impose specific obligations on the manufacturer, such as the submission of data on long-term safety and efficacy, and "are subject to annual renewal".
Once these data are presented, at the annual review, the conditional authorization can be transformed into a standard. The European agency has already set "a schedule for each vaccine within which we expect the latest pending data to be submitted: for all vaccines, these will be the final clinical trial reports of the pivotal study." For the Comirnaty, final clinical trial reports are expected to be submitted in December 2023.