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Mainz (dpa) - The German vaccine manufacturer Biontech and its US partner Pfizer want to apply for approval of their corona vaccine for children from the age of twelve in the EU shortly.
A company spokeswoman for the German press agency said that this application will probably be made “in the next few days” to the European approval authority EMA. The «Spiegel» had previously reported that this application should be submitted next Wednesday. "We have submitted the study data for 12 to 15-year-olds in the USA for conditional approval, in Europe we are on the last legs before submission," said the news magazine Biontech boss Uğur Şahin as saying. The examination of an application for approval for corona vaccines at the EMA usually takes a few weeks. So far, children cannot be vaccinated in Germany.
The product from Biontech / Pfizer is only conditionally approved in the EU and the USA for people aged 16 and over.
If the application is submitted to the EMA in the next few days and the examination takes around four to six weeks, EMA approval could take place in the beginning to mid-June in the best case.
After that, vaccinations for 12 to 15 year olds could begin.
With a view to the coming school year and the desired expansion of the vaccinated population groups with the aim of herd immunity, this would be an important step.
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Biontech and Pfizer recently announced that a clinical study in the age group 12 to 15 years in the US had shown 100 percent effectiveness. The vaccination was well tolerated. The side effects would have corresponded to those in the age group from 16 to 25 years, the companies said. For safety reasons, the health of the nearly 2,300 participants in the study in the USA would be monitored for up to two years after receiving the first dose of the vaccine, it said.
In parallel, the clinical study by Biontech and Pfizer on the effectiveness and safety of their corona vaccine in children between six months and eleven years inclusive is ongoing.
Biontech is assuming that reliable data will be available by September, said the company spokeswoman for the dpa.
It will therefore take some time before the first children in this age group can be vaccinated with the vaccine, as Biontech / Pfizer will only submit an application for approval to the EMA after this intermediate step.
Its examination will then probably take a few weeks again.
© dpa-infocom, dpa: 210429-99-400423 / 4