Biontech wants to apply for vaccination approval for children 12 years and older | Free press

Until now, there are no corona vaccinations for boys and girls under the age of 16. That could change quickly: an important step in this regard will be taken in the coming days.

Mainz (dpa) – The German vaccine manufacturer Biontech and its American partner Pfizer want to apply for approval for their corona vaccine for children from the age of 12 in the EU soon.

A company spokeswoman for the German news agency said that this application will likely be submitted to the European approval authority EMA “in the coming days”. De Spiegel had previously reported that this application must be submitted next Wednesday. “We have submitted the research data for 12-15 year olds in the US for conditional approval, in Europe we are on the last legs before submitting,” said news magazine Biontech boss Uğur Şahin. It usually takes several weeks to process an application for approval for corona vaccines at the EMA. So far, children in Germany cannot be vaccinated.

Federal Health Minister Jens Spahn announced vaccinations for more than 12-year-olds over the summer. “As of today, if nothing out of the ordinary happens: by summer holidays at the latest, we can vaccinate more than 12-year-olds when the approval is given,” said the CDU politician. We must of course wait for the approval to come, Spahn said. But he expects it soon.

The Biontech / Pfizer product is only conditionally approved in the EU and the US for people 16 years of age and older. If the application is submitted to the EMA in the next few days and the investigation takes approximately four to six weeks, the EMA approval can ideally take place early to mid-June. After that, the vaccinations for 12-15 year olds could start. In view of 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.

Biontech and Pfizer recently announced that a clinical study in the age group of 12 to 15 years in the US had shown 100 percent effectiveness. The vaccination was well tolerated. The side effects would be similar to those in the 16 to 25-year-old age group, the companies said. For safety reasons, the health of the nearly 2,300 study participants in the United States would be monitored for up to two years after receiving the first vaccine dose, the company said.

In parallel, the clinical study conducted by Biontech and Pfizer on the effectiveness and safety of their corona vaccine in children between six months and eleven years old. Biontech expects reliable data to be available in September, the company spokeswoman for the DPA said. 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. The investigation will then probably take a few more weeks.

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