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Pfizer asks UK's MHRA to approve its COVID-19 vaccine in adolescents

The vaccine has been authorised in the US for 12- to 15-year-olds

A spokesman for Pfizer confirmed today that the company has submitted data for its BioNTech-partnered COVID-19 vaccine in 12- to 15-year-olds to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

In the UK, the Pfizer/BioNTech is currently only approved for use to prevent COVID-19 in individuals aged 16 and over.

Earlier this month, NHS England created contingency plans for vaccination of children of secondary school age later this year, with this proposal to be included in ‘core planning scenario’ documents showing that a single dose could be offered to children aged 12 and over at the start of the autumn term.

The decision to submit the vaccine to UK regulators closely follows the news that the US Food and Drug Administration (FDA) has expanded the emergency use authorisation (EUA) of the Pfizer/BioNTech vaccine to include this age group.

“[The] expansion of our EUA represents a significant step forward in helping the US government broaden its vaccination programme and help protect adolescents before the start of the next school year,” said Albert Bourla, chairman and chief executive officer of Pfizer.

In March, Pfizer and BioNTech revealed positive data for their vaccine in adolescents aged 12 to 15, both with or without prior evidence of SARS-CoV-2 infection.

In this age group, the vaccine demonstrated 100% efficacy and also produced robust antibody responses, which exceeded those recorded earlier in vaccinated participants aged 16 to 25.

The vaccine was also well tolerated, with side effects in this study found to be ‘generally consistent’ with those seen in participants aged 16 to 25.

“The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant,” said Ugur Sahin, chief executive officer and co-founder of BioNTech.

“It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones,” he added.

The companies also announced earlier this week that they have submitted the data from this trial to a number of additional global regulators, including the European Medicines Agency (EMA).

Article by
Lucy Parsons

13th May 2021

From: Research, Regulatory



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