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The European Medicines Agency (EMA) could decide by Christmas whether to approve Biontech and Pfizer’s CoV vaccine for children as young as five. “The current timeline for the evaluation is approximately two months,” the EMA told Redaktionsnetzwerk Deutschland (RND) today.
The agency is committed to “doing everything in its power to complete the evaluation within the shortest possible time,” RND quoted an EMA spokeswoman as saying. At the same time, however, a careful and robust evaluation of all available efficacy and safety data in this very young age group must be ensured, the spokeswoman added.
More studies expected
Additional data from ongoing pediatric studies by Biontech and Pfizer would also be included in the assessment. Those are expected later in November, she said.
Additional information or analysis may be needed that could delay a recommendation, the spokeswoman added. In any case, she said, the current timetable is a shortened one compared with similar trials outside of a pandemic.
The vaccine, from manufacturers Biontech and Pfizer, has so far been approved in the EU for people aged 12 and older. Now it is being tested whether it may also be used for the age group of five to eleven. According to the report, the EMA had begun the corresponding review on October 18.
-source: orf.at/picture/pixabay.com
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