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Vaccination against Covid-19
Photo: Sina Schuldt / picture alliance / dpa
Most recently, the European Medicines Agency Ema assumed it would take several months until a possible approval of a corona vaccine for children.
But now it seems to be going faster.
A decision could already be made by Christmas whether the vaccine from Biontech / Pfizer will be approved for children from the age of five.
"The current schedule for the evaluation is about two months," said the Ema on Wednesday to the editorial network Germany (RND).
A spokeswoman was quoted as saying that the agency is striving "to do everything in its power to complete the assessment as quickly as possible."
At the same time, however, a careful and solid assessment of all available efficacy and safety data in this very young age group must be ensured, the spokeswoman said.
Additional data from ongoing pediatric studies by Biontech and Pfizer would also be included in the assessment.
These are expected in November.
"The evaluation depends on the incoming data and what it shows."
Additional information or analysis may be required that could delay a recommendation, the spokeswoman said.
The current schedule is already a shorter one compared to similar exams outside of a pandemic.
The vaccine from the manufacturers Biontech and Pfizer has so far been approved in the EU for people aged twelve and over.
On Tuesday, an advisory body to the US FDA had spoken out in favor of emergency approval of the corona vaccine from Biontech / Pfizer for children between the ages of five and eleven.
The recommendation is not binding, but the FDA usually follows the experts.
A final FDA decision is expected later this week.
Sars-CoV-2 is currently being detected in Germany in particular in children and adolescents.
The seven-day incidence in 5- to 14-year-olds was given by the Robert Koch Institute (RKI) on Wednesday at 218.1, and the trend is rising.
as / dpa / AFP
