UK approves Pfizer jab for 12 to 15-year-olds

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Boy being immunised

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The UK regulator has approved the use of the Pfizer-BioNTech vaccine in children aged 12-15, saying it is safe and effective in this age group and the benefits outweigh any risks.

The MHRA said it had carried out a “rigorous review” of the vaccine in adolescents.

The UK’s vaccines committee will now decide whether children should get the jab.

The Pfizer vaccine is already approved for use in people aged 16 and over.

Dr June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA) said the safety of the vaccine in 12-15 year olds would be carefully monitored.

“No extension to an authorisation would be approved unless the expected standards of safety, quality and effectiveness have been met,” she said.

The Joint Committee on Vaccination and Immunisation (JCVI) must now advise government on whether this age group should be vaccinated as part of the UK rollout.

A spokesperson for the Department of Health and Social Care said it would be “guided by the expert advisors and will update in due course”.

At present, there is no routine vaccination of under 18s against Covid in the UK.

However, current advice is that 16-18 years old who are in a priority group or who live in the same house as someone who is extremely vulnerable, should be offered a Covid vaccine.

The EU recently approved the Pfizer-BioNTech vaccine for 12-15 year olds, and the US and Canada started vaccinating children in this age group earlier this month.

Germany has indicated it will start vaccinating children over 12 from 7 June.

Alongside the regulator, a UK independent advisory group also analysed data on the quality, effectiveness and safety of the vaccine in adolescents against any potential risk of side effects.

The Commission on Human Medicines concluded that “its benefits outweigh any risk”.

The data is based on more than 2,000 children aged 12-15 years old who took part in trials of the Pfizer vaccine. There were no cases of Covid from a week after the second dose – compared to 16 cases in the placebo group, and the vaccine appeared to work as well in adolescents as in young adults aged 16-25.