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AMSTERDAM (dpa-AFX) – The European Medicines Agency (EMA) has recommended conditional marketing authorization for the corona vaccine of the British-Swedish group Astrazeneca in the EU. Admission is to apply to people aged 18 and over. The EMA announced on Friday in Amsterdam. The final decision on approval must now be made by the EU Commission – this is a formal matter and could still be made on Friday. This clears the way for the third vaccine against Covid-19 in the EU.
In Great Britain, the preparation that Astrazeneca developed together with the University of Oxford has been in widespread use since the beginning of January. So far, only vaccines from the manufacturers Pfizer / Biontech and Moderna have been approved in the EU. The vaccine from Astrazeneca is considered particularly inexpensive and handy for mass vaccinations.
Despite concerns previously expressed by other experts, EMA experts recommend approval for people of all ages 18+. Even if there were only comparatively few test persons over 55 years of age, this is justifiable. The EMA justifies this decision with the good test results in the other age groups and experience with other vaccines. The manufacturer had previously rejected reports as false that the vaccine was only eight percent effective in people over 65.
The big question, however, is when will the vaccine be delivered? The EU Commission is involved in an open dispute with the manufacturer. Because of alleged production problems, large quantities of the vaccine for Germany and other EU countries will not be delivered until weeks or months later. The EU had ordered a total of 400 million vaccine doses.
The data on this active ingredient have been thoroughly checked, said EMA boss Emer Cooke, “the scientific basis of our work underscores our firm commitment to ensure the health of EU citizens.” Even after the recommendation and a conditional marketing authorization, the experts would continue to monitor data on safety and effectiveness.
In the case of conditional approval, the manufacturer is obliged to submit data to the EMA afterwards, for example on the long-term effect. Information on possible side effects will also continue to be checked. / Ab / DP / men