Pfizer asks UK regulator to approve vaccinations in teenagers following approval in the US

Pfizer has asked the UK regulator to approve its vaccine for use in young teenagers, as US watchdogs signalled their approval.

The pharmaceutical giant has formally asked the Medicines and Healthcare products Regulatory Agency (MHRA) for permission to use the jab in 12- to 15-year-olds, one of the age groups most responsible for spreading the virus.

Given the organisation's fast-track review process, it is likely the vaccine would be approved well before the end of July, the point at which the Government aims to have offered a jab to all adults.

Ministers secured an extra 60 million doses of the drugs last month, on top of the 40 million originally purchased.

It follows a trial which showed 100 per cent efficacy among 12- to 15-year-olds.

In a statement on Monday, the US Food and Drug Administration hailed their emergency approval as a “significant step” in the fight against Covid.

On Tuesday night, a spokesman for Pfizer told The Telegraph: “We can confirm that the companies have submitted a request to the MHRA to expand the use of the Pfizer/BioNTech Covid vaccine in the UK to adolescents.”

However, as a senior vaccine advisor to the Government questioned the ethical basis of rolling out the drug to teenagers.

Professor Anthony Harnden, deputy chair of the Joint Committee on Vaccination and Immunisation (JCVI), which advises ministers who should get the vaccine following MHRA approval, said the group would be closely watching the US rollout for safety signals.

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“The overwhelming majority of children and young people don’t seem to suffer severe effects from Covid,” he said.

“Although there is a minority that get very sick, the vast, vast, majority don’t.”

Professor Harnden acknowledged a risk from long-Covid and the educational harm of going off sick.

But he added: “Those are the only direct benefits [from a vaccine] for children, and therefore most of the benefits of vaccinating children would be for the protection of the wider community, those unvaccinated adults or those adults for whatever reason who haven’t responded as well.

“You would be vaccinating a group of children essentially to prevent illness in the community, so you’d have to be absolutely sure of the safety of these vaccines in children.

“There are a lot of ethical considerations.”

Unlike with the AstraZeneca jab, the Pfizer vaccine has not been associated with an increased risk of blood clots or any other serious complication.

However, Professor Harnden said children are “not little adults”.

“You’ve still got safety considerations to look at quite carefully because they can respond differently to different pharmaceutical drug interventions.

“So we can’t be absolutely clear that just because it’s completely safe in adults it will be safe in children.

“We need to find that out from the data.”

A paediatrics specialist, he said the JCVI would closely watch the use of Pfizer in US teenagers before recommending it for use in the UK.

The group has not yet formally discussed the matter.

It comes as trials of the Pfizer vaccine are ongoing in children aged from six months to 11 years.

Any decision to roll out the jab in children would place greater stress on supplies, particularly after the JCVI last week decided to extend its recommendation that 28- to 29-year-olds avoid the AstraZeneca jab to thirty-somethings.

Meanwhile, the EU has announced that it will not renew its AstraZeneca contract as it pivots towards Pfizer.

The firm has also applied to the European Medicines Agency to use the jab in people aged 12 to 15.

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