Mainz (dpa) – Children and young people from 12 years old can possibly be vaccinated against Corona before the new school year.
German vaccine manufacturer Biontech and its US partner Pfizer are looking to request approval for their vaccine for children aged 12 to 15 in the EU soon, a Biontech spokeswoman said. Federal Health Minister Jens Spahn assumed that children of this age group could receive their first vaccination during the summer holidays at the latest when admitted. “As of today, if nothing out of the ordinary happens,” said the CDU politician.
The approval request is expected to be submitted to the European approval authority EMA “in the coming days,” said Biontech’s spokeswoman for the German news agency. 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 Ugur Şahin. It usually takes several weeks to process an application for approval for corona vaccines at the EMA. So far, no vaccine has been approved in Germany for children under 16 years of age.
Pharmaceutical products must be individually adapted for children and adolescents, as their organism does not function according to the “small adult” principle. That’s why our own studies are also needed before a vaccine is approved.
Vaccinations for the youngest of the population seem more urgent now than at the start of the pandemic – at least children were not considered motorists at the time. However, according to the Robert Koch Institute in Germany, their role has changed due to the dominance of the more contagious virus variant B.1.1.7.
The number of infections in children is increasing significantly, RKI chairman Wieler said on Thursday. “Children certainly contribute to the infection process.” The long-term consequences, which also occur in children, should not be overlooked in the risk assessment.
The weekly incidence is currently between 141 cases in the very youngest up to four years old and 260 in the 15-19 year olds, calculated for every 100,000 inhabitants. In older teens, these are the highest incidence rates in any age group. For 10 to 14-year-olds, this is currently 234 per 100,000 inhabitants, according to the RKI.
Covid-19-related outbreaks currently mainly affect private households and the professional environment, but also daycare centers and schools, according to the RKI management report. President Lothar Wieler makes it no secret that he thinks the national incidence of 165 emergency brakes for school closures is far too high from a health protection point of view.
The Biontech / Pfizer product has so far only been conditionally approved in the EU and 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.