When is the corona vaccination expected to be approved for five to eleven year old children in Europe?
Biontech and Pfizer filed an application with the European Medicines Agency in mid-October to obtain an extension of their vaccine for the group of five to eleven year olds. If the EMA evaluates the study data as positive, approval could take place around mid / end of November. Because the authority needed about four to six weeks after the application was submitted for comparable previous examinations.
It is questionable whether the mRNA vaccine will then be used equally widely in Germany once it has been approved in Europe. Experts assume that the Standing Vaccination Commission (Stiko) will maintain its current course and, as before with the vaccination for older children, will initially not give a generally applicable recommendation for vaccinating children under 12 years of age.
When the EMA approved Biontech’s vaccine for 12 to 15-year-olds at the end of May, Stiko only gave a limited recommendation, for example for young people with previous illnesses or other risk factors. At the time, the experts considered the data to be insufficient in view of possible side effects. Stiko only issued an unreserved recommendation in mid-August – two and a half months after approval in the EU. The experience after ten million vaccinated adolescents in the USA had shown that the benefits of vaccination outweigh the risk of very rare vaccine side effects, the panel said at the time.
The Stiko always placed the focus on the benefit for the children in the evaluation, while in politics the call for the vaccination of the children was also called for for social reasons and reasons of herd immunity. Jörg Dötsch, President of the German Society for Child and Adolescent Medicine, shares the Stiko attitude, as he recently said in an interview with the Handelsblatt: “Children must not be vaccinated to protect the adult group. Adults need to have the sense of responsibility to do this themselves, ”he says. He advises parents to wait for the assessment of the risk of child vaccination.
How safe is the vaccination for five to eleven year olds?
The corona vaccine from Biontech and Pfizer shows an effectiveness of 90.7 percent against symptomatic corona infections in children between the ages of five and eleven in advanced clinical studies. This emerges from the published documents that the US company Pfizer has submitted to the FDA for emergency approval. The information is based on a study with 2,250 participants. A severe course of the disease was not registered.
There were three Covid-19 cases in the vaccine group and 16 cases in the placebo group. In the study, twice as many children received the vaccine as the placebo. The children between the ages of five and eleven received two doses of ten micrograms at an interval of 21 days, which is significantly fewer than those over 12 years old, for whom a dose of 30 micrograms is approved.
The immunologist Prof. Carsten Watzl rated the study data positively on Twitter: The younger children would have produced more antibodies to the vaccination than those over 12, including more neutralizing antibodies against the Delta variant. “The vaccination seems to be tolerated very well in the five to eleven year olds and generates high antibodies and very good protection,” said Watzl.
Serious side effects such as inflammation of the heart muscle (myocarditis), which occasionally occurred in adults, were not observed after the vaccination of the five to eleven year olds. But Watzl also notes that only 1,518 vaccinated children were examined – an order of magnitude in which one would not see rare side effects.
Who else is doing research on vaccines for young children?
The US vaccine manufacturer Moderna announced on Monday this week that it had successfully tested its vaccine against Covid-19 in children. According to Moderna, the results of a phase 2/3 study with 4753 participants between the ages of six and eleven showed a “robust” number of antibodies.
Complete data sets have not been published, and the study has not yet been presented in any specialist journal. Moderna plans to submit the data to the American and European Medicines Agency and other regulatory authorities shortly. In the study, the children were given two doses of 50 micrograms each – half the dose for adults. The most common side effects included fatigue, headache, fever, and pain at the injection site. Moderna’s corona vaccine is already approved in Europe for children and adolescents from the age of twelve.
In addition, Moderna and Biontech are also researching their vaccines in babies and children of preschool age. Biontech and Pfizer plan to present their first results later this quarter, for age groups from two to five years and from six months to two years.
More: Stiko now recommends corona vaccination for all children from the age of twelve.