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UPDATE 3-Pfizer seeks UK approval for use of COVID-19 vaccine in teenagers

05/11/2021 17:12
UPDATE 3-Pfizer seeks UK approval for use of COVID-19 vaccine in teenagers

Pfizer submits data from trials in 12- to 15-year olds

EU also reviewing shot for same group

Canada, U.S. have started vaccinating children with Pfizer shot

Adds details on vaccine, background

- Pfizer PFE.N is seeking British approval for the use of its COVID-19 vaccine among 12- to 15-year olds and has submitted data to the health regulator, a company representative said on Tuesday, paving the way for inoculation of adolescents in the country.

The vaccine, developed along with Germany's BioNTech 22UAy.DE, has already been approved in the United States and Canada for use against COVID-19 infections in children and young adults. nL1N2MX2HH

"I can confirm we've submitted data on the efficacy of the vaccine in 12 to 15 year olds for review by U.K. MHRA," an official for the U.S. drugmaker told Reuters, referring to the Medicines and Healthcare products Regulatory Agency.

Health officials are banking on vaccines to end the pandemic, but are worried that some parents will be hesitant in vaccinating their children due to fears of potential side effects and long-term risks. Kids under 12 have so far been less susceptible to COVID-19.

The drugmakers have said their shot is safe, effective and produced robust antibody responses in children as young as 12 years of age. nL1N2LT16A

The vaccine, which uses mRNA technology to deliver instructions to the human body to build immunity against the illness, is also being tested in children aged two to 11, with safety and efficacy data expected in September, Pfizer has said.

Although other drugmakers, including AstraZeneca AZN.L, Moderna MRNA.O and Johnson & Johnson , are working on vaccines for children, Pfizer and BioNTech have managed to steal a march.

Pfizer's vaccine, branded Comirnaty, is also under an EU review for use in children aged 12 to 15 years, with the head of the region's medicines regulator saying an approval could come as early as end-May. nL8N2MY321

The Telegraph earlier reported on the British review, saying the vaccine was likely to be approved before the end of July.

The MHRA did not immediately respond to a Reuters request for comment.


(Reporting by Pushkala Aripaka, Nandakumar D and Derek Francis in Bengaluru, Alistair Smout in London; Editing by Richard Pullin, Stephen Coates and Anil D'Silva)

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