Covid vaccine for younger people: BioNTech drives approval for children

Following positive study results, BioNTech and Pfizer want to apply for approval of their Covid-19 vaccine for use in children as soon as possible. Health Minister Spahn expects approval for the beginning of 2022.

BioNTech and Pfizer want to apply for approval of their corona vaccine for children aged five to eleven as soon as possible. The vaccine has been shown to be safe and effective in studies, announced the two pharmaceutical companies in Mainz. Previously, the first results of the registration study for the vaccine Comirnaty for children under twelve had been evaluated.

In the study, five to eleven year old children were vaccinated twice with an interval of three weeks – but the dose was only a third of what people aged twelve and over were vaccinated. The study included data from almost 2,270 children in this age group. According to the company, the vaccine was “safe, well tolerated and showed robust neutralizing antibody responses”.

The antibodies formed after the corona vaccination therefore have a good protective effect. The antibody responses in the children are comparable to those from a previous study of 16 to 25 year olds who received three times the dose. Possible side effects are also comparable.

Application “before the start of winter”

“We are pleased that we can present the data for this group of school-age children to the regulatory authorities before the start of winter,” said BioNTech co-founder Ugur Sahin. Pfizer boss Albert Bourla sees the study data as a “solid basis” for the approval of the vaccine also for younger people. This is also urgent in view of the spread of the delta variant and the associated considerable risk for children.

BioNTech and Pfizer are expected to apply to the FDA for emergency approval for the vaccine in the United States. According to Pfizer, this should be done by the end of September. The data should also be submitted as quickly as possible to the European approval authority EMA and other approval authorities around the world. The US vaccine manufacturer Moderna is also examining the use of its vaccine in children of primary school age. BioNTech and Pfizer expect results of the registration study for children under five years of age later this year. These children receive an even lower dose than five to eleven year olds.

Spahn: STIKO recommendation will take longer

Federal Minister of Health Jens Spahn is now expecting approval for a corona vaccine for children at the beginning of next year. “I assume that the approval for a vaccine for children under twelve years of age will come in the first quarter of 2022,” said the CDU politician to the newspapers of the Funke media group. “Then we could protect the younger ones even better.” At the same time, the minister pointed out that time could again pass between approval and a vaccination recommendation by the Standing Vaccination Commission (STIKO). “A recommendation from the Standing Vaccination Commission will also come a little later in this case,” said Spahn.