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BioNTech to seek approval soon for vaccine for children as young as 5
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FRANKFURT — 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 is 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 6 months to 2 years later this year. ...
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FDA official hopeful younger kids can get shots this year
The Food and Drug Administration’s vaccine chief said Friday the agency will rapidly evaluate COVID-19 vaccinations for younger children as soon as it gets the needed data — and won’t cut corners.
Dr. Peter Marks told The Associated Press he is “very, very hopeful” that vaccinations for 5- to 11-year-olds will be underway by year’s end. Maybe sooner: One company, Pfizer, is expected to turn over its study results by the end of September, and Marks say the agency hopefully could analyze them “in a matter of weeks.” ...