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UPDATE 2-Pfizer asks UK regulator to approve vaccine for teenagers

05/11/2021 17:12
UPDATE 2-Pfizer asks UK regulator to approve vaccine for teenagers

Changes sourcing, adds details and background

- Pfizer Inc PFE.N has submitted data on its COVID-19 vaccine among 12- to 15-year olds to Britain's health regulator, a company spokesman said on Tuesday, paving the way for its authorization to inoculate children in the country.

"I can confirm we've submitted data on the efficacy of the vaccine in 12 to 15 years olds for review by U.K. MHRA," the spokesman told Reuters by email.

The move comes a day after U.S. regulators authorized the vaccine made by Pfizer and BioNTech SE 22UAy.DE for use in children as young as 12. nL1N2MX2HH

In March, Pfizer and BioNTech said their COVID-19 vaccine was safe, effective and produced robust antibody responses in 12- to 15-year olds, citing a trial of 2,260 adolescents, which resulted in 100% efficacy in preventing the illness.nL1N2LT16A

Pfizer has said it expects to have safety and efficacy data on the vaccine for children aged 2 to 11 in September, when it plans to ask for that age group to be included in the emergency authorization.

The Telegraph earlier reported that Pfizer had asked Britain's Medicines and Healthcare products Regulatory Agency for approval for the vaccine.

(Reporting by Nandakumar D and Derek Francis in Bengaluru; Editing by Richard Pullin and Stephen Coates)

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