Vaccinating children against Covid-19 in Germany: The Standing Committee on Immunisation (Stiko) does not recommend vaccinating children under 12 years of age with BioNTech / Pfizer.
The German concern BioNTech and its American partner Pfizer have applied for approval in Europe of the vaccine against Covid-19 for children aged 5 to 11 years.
Both companies say they have submitted a clinical trial report to the European Medicines Agency (EMA). The same data has already been submitted to the U.S. Medicines Agency (FDA) on October 7 for emergency anti- COVID 19 serum approval , Deutsche Welle reports.
Vaccinating children against Covid-19 in Germany. STIKO objection
The Standing Committee on Immunisation (Stiko) has objections to the BioNTech / Pfizer regulation. Commission member Dr. Martin Terhardt believes that the report does not yet provide sufficient data on possible rare side effects of vaccination with this preparation in young children.
In his opinion, the group on which the vaccine was tested was too small. Such data may only be available after the use of the serum on a larger scale. “It is different from the formulation for 12-year-olds that was already used in other countries when we made the recommendation,” says Terhardt in an interview with Tagesspiegel.
According to the expert, until sufficient data are available, Stiko may recommend the BioNTech / Pfizer vaccine in the first phase , only to children with existing medical conditions. “I am thinking especially of overweight children and teenagers,” says Terhardt, and adds. “They have an increased risk of contracting COVID-19.”
Children, he says, have a much lower risk of developing severe forms of the coronavirus compared to adults. “Schools and kindergartens often don’t become infection centers, but children can transmit the virus,” says Terhardt. If the number of infections increases, the rate of more serious diseases will also increase. “This is the problem that concerns us, not the normal symptoms of a cold caused by a virus.”
The European Medicines Agency (EMA) has started a process to evaluate the use of BioNTech / Pfizer in children aged 5 to 11 years
“EMA’s Committee for Medicines for Human Use (CHMP) will review data on the vaccine, including the results of an ongoing clinical trial in children 5 to 11 years of age, with a view to deciding whether to recommend extending the use of the vaccine. The CHMP opinion will then be forwarded to the European Commission, which will issue a final decision, ”reads the press release sent by EMA to media representatives.
The evaluation is to be completed “in a few months, unless additional information is needed”.