BioNTech to seek global approval to use its COVID-19 vaccine in 5-11 year olds: report
2021-09-10 from cbc.ca
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 German 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.
BioNTech has said it expected to file its regulatory dossier on the five to 11 year olds in September. It has also laid out plans to seek approval in children aged six months to two years later this year.
Tuereci also told Spiegel that final production steps were being adjusted to bottle a lower-dose pediatric version of its established Comirnaty vaccine. It is currently approved for adults and youngsters at least 12 years of age.
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