Pfizer Inc and BioNTech SE said on Monday their Covid-19 vaccine induced a robust immune response in five to 11-year-olds.
Pfizer and BioNTech say their Covid-19 vaccine has shown positive and safe results in trials with children aged five to 11. Stock photo.Pfizer Inc and BioNTech SE said on Monday their Covid-19 vaccine induced a robust immune response in five to 11-year-olds, and they plan to ask for authorisation to use the vaccine in children in that age range in the US, Europe and elsewhere as soon as possible.
“These trial results provide a strong foundation for seeking authorisation of our vaccine for children five to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”on whether the shot is safe and effective in younger children within three weeks of the companies submitting a request for authorisation, two sources told Reuters earlier this month.
The companies' vaccine, called Comirnaty, is already authorised for use in children as young as 12 in many countries, including the US. The vaccine was originally authorised for emergency use in people 16 or older in the US in December 2020 and received full US approval in that age group last month. Unlike the larger clinical trial the drugmakers previously conducted in adults, the 2,268 participant paediatric trial was not primarily designed to measure the vaccine's efficacy by comparing the number of Covid-19 cases in vaccine recipients to those who received a placebo.
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