BioNTech has said it is expected to file its regulatory dossier on the five to 11-year-olds in September.
Pfizer-BioNTech is set to request approval across the globe to use its COVID-19 vaccine in children as young as five over the next few weeks and preparations for a launch are on track, the biotech firm's two top executives told Der Spiegel.
"Already over the next few weeks we will file the results of our trial in five to 11-year-olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe," Chief Medical Officer Oezlem Tuereci told the news weekly. The confident statements underscore the lead that BioNTech, which collaborates with Pfizer, holds in the race to win broad approval to vaccinate children below the age of 12 in Western countries.Related
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