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Vaccinations for five to eleven year olds could soon be approved
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Then Tardif / LWA / Getty Images
The vaccine manufacturer Biontech / Pfizer has released the data of its clinical study for a Covid-19 vaccine for children under 12 years of age.
The vaccination was safe and well tolerated for the test subjects between five and eleven years of age, according to a message available to SPIEGEL.
It also led to a robust immune response.
The vaccine from Biontech / Pfizer - Comirnaty - has only been approved for ages 12 and above.
The manufacturers had already announced two weeks ago that it would not be long before the vaccination would also be tested for younger people.
The study results for this age group will be presented to the authorities worldwide in the coming weeks and approval will be applied for, said Özlem Türeci, chief physician at Biontech.
Biontech / Pfizer is the first manufacturer in the world to officially apply for approval for children under the age of 12.
Stiko recommendation could take a while
Federal Health Minister Jens Spahn (CDU) announced on Monday that he did not expect to be vaccinated against Covid-19 until the beginning of 2022. The minister pointed out that time would pass again 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.
Stiko checks data collected on vaccines around the world and makes vaccination recommendations on this basis. In the spring, she hesitated for a long time before issuing a vaccination recommendation for 12 to 17-year-olds because the panel had assessed the data situation for this age group as inadequate. The politicians therefore ignored the Stiko and promised vaccination offers to 12 to 17-year-olds without a corresponding Stiko recommendation. Many saw it as dismantling the Stiko and ignoring scientific evidence. Spahn may now hold back with hasty promises in order to avoid a renewed dissent.
Biontech's study results now sound promising. The children between five and eleven years of age received a lower dose than the elderly in the study. Instead of the usual 30 micrograms per vaccine dose for over 12-year-olds, the younger children only received ten micrograms per vaccination. They also have to be vaccinated twice, according to the information, in order to produce a sufficient number of neutralizing antibodies. The time interval between vaccinations in the study was 21 days.
"We are pleased to be able to submit the study results for school-age children to the regulatory authorities before winter," said Biontech founder Uğur Şahin, according to the announcement.
"The safety profile and immunogenicity data in children between five and eleven years of age at a lower dose are the same as those in the older population at a higher dose."
The phase II / III study was carried out with 2268 children between the ages of five and eleven.
One month after the second vaccination dose, the children showed a strong antibody response.
According to Biontech, the effectiveness of the vaccine is 95 percent - just as high as that of the elderly.
Babies could also be vaccinated soon
The study data for even smaller children, between two and five and babies between six months and two years, are currently being collected.
Corresponding results are expected by the end of the year.
In an interview with SPIEGEL, the Biontech founders announced that they were already preparing the lower dosages for the younger generation.
At the same time, the two Biontech founders asked to do everything possible to convince undecided people to vaccinate in the coming weeks.
It is not clear from the communication whether the side effects of five to eleven year olds were different from those of the older group.
The manufacturers only refer generally to the possibility of allergies and the occasional occurrence of myocarditis after vaccination.
Some doctors are already vaccinating children under the age of 12 against Covid-19.
This so-called off-label use can be justified if there is a specific indication - for example if the children are at a very high risk of seriously contracting Covid-19.
The attending physician can then decide, together with the legal guardian, whether the children should already be vaccinated.
The vaccination rate in Germany is currently around 63 percent, hardly any people can be vaccinated.
In order to protect children and adolescents from the virus as well as possible and also to be able to achieve the goal of containing the pandemic, experts consider vaccination of children to be essential.
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