Biontech applies for vaccine approval for children

So far there are no corona vaccinations for boys and girls under 16 years of age.

Corona vaccination

Mainz (dpa) – The German vaccine manufacturer Biontech and its US partner Pfizer have, according to their own information, applied to the European approval authority EMA for approval of their corona vaccine for children and adolescents aged 12 to 15 years.

The company announced on Friday that it was about adapting and expanding the existing approval to this age group. As soon as the EMA approves the change, the modified conditional approval will be valid in all 27 member states of the EU.

The product from Biontech / Pfizer has so far only been conditionally approved in the EU and the USA for people aged 16 and over. In the USA, the two partners have already submitted an application to the Food and Drug Administration (FDA) to extend the existing emergency approval for the vaccine to include the 12 to 15 year olds group.

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.

The EMA usually needs a few weeks to review applications for approval for corona vaccines. This means that, in the best case scenario, EU approval could take place between the beginning of June and mid-June with a processing time of four to six weeks. Then vaccinations for 12 to 15 year olds could start, provided that sufficient vaccine is available. 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.

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 old is ongoing. According to its own information, Biontech assumes that reliable data will be available by September. 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 more weeks.

© dpa-infocom, dpa: 210430-99-417055 / 2