Coronavirus: UK regulator approves Pfizer Covid vaccine for 12 to 15-year-olds


The Pfizer Covid vaccine is safe and effective for children aged 12 to 15, the UK’s regulator ruled today.

It was approved for over-15s in December last year and it will now be allowed to be given to anyone over the age of 12 because the ‘benefits outweigh any risk’.

Ministers have asked the Joint Committee on Vaccination and Immunisation (JCVI) whether to give the jab to teenagers – the current rollout is set to stop at age 18 except for children with serious health conditions. 

Children aren’t yet given vaccines because their risk of getting serious Covid is so tiny and their immunity would likely only protect older adults, making it a complex issue.

But ministers and government advisers will be emboldened by the fact Pfizer’s trials have not seen any new side effects and very few serious ones, with most teenagers suffering only ‘mild to moderate’ effects like sore arms and tiredness.

A clinical trial of around 2,000 teenagers found nobody given two doses tested positive for coronavirus, compared to 16 who were unvaccinated. The jab appears to work just as well as it does in adults, health chiefs said. 

Pressure to vaccinate children could build up in the coming months as it emerges the now-dominant Indian variant is spreading quickly among them and may be more likely to make them sick. 

Ministers might be forced to give youngsters a jab if they want to keep the super-infectious strain under control.

The UK’s vaccine regulator today gave the green light for the Pfizer jab to be given to 12 to 15-year-olds (Pictured: A teenager is given the jab in Florida, US)

Pfizer's vaccine was the first in the world to be approved for adults when the UK led the way by green-lighting it in December, and it is now the first jab to be approved for under-16s in Britain (stock image)

Pfizer’s vaccine was the first in the world to be approved for adults when the UK led the way by green-lighting it in December, and it is now the first jab to be approved for under-16s in Britain (stock image)

Dr June Raine, chief of the MHRA – the Medicines and Healthcare products Regulatory Agency – said: ‘We have carefully reviewed clinical trial data in children aged 12 to 15 years and have concluded that the Pfizer/BioNTech Covid-19 vaccine is safe and effective in this age group and that the benefits of this vaccine outweigh any risk.’

She added: ‘No extension to an authorisation would be approved unless the expected standards of safety, quality and effectiveness have been met.’

The decision comes at a pivotal time in Britain’s outbreak as cases are back on the rise and there are fears the new Indian ‘Delta’ variant is going to spark a third wave.

Children’s role in fuelling the next surge is unlikely but they will have some of the highest infection rates because they aren’t vaccinated, which will allow the virus to keep circulating and increase the risk of spillover into high-risk older people.

DECISION ON CHILDREN’S JABS COULD FALL TO BORIS JOHNSON 

The decision on whether to vaccinate children could fall to Boris Johnson and his government ministers, instead of health chiefs and scientists, because it is ethically complicated. 

The Joint Committee on Vaccination and Immunisation (JCVI) is expected to ‘come up with a menu of options’ for the Prime Minister but not to offer a definitive recommendation on jabs for those under the age of 18.   

Children aren’t yet given vaccines because their risk of getting serious Covid is so tiny and their immunity would likely only protect older adults, making it a complex issue – vaccinating against measles, for example, directly protects the child so is more clear-cut.

Ministers will be forced to decide whether the tiny risk of side effects in children is worth the benefit of protecting more adults and stifling the virus. 

 JCVI deputy chair Professor Anthony Harnden said on BBC Breakfast in May: ‘We do know that the majority of children do not have huge risk of complications, whether we vaccinate for educational purposes, whether we vaccinate to protect others in the population, these are the ethical issues, there are a lot of issues to think about.

‘It’s a complicated position to decide on the immunisation of children, of course, then there’s the wider global ethical argument about the use of vaccine in children when there are other people in the world that are at risk of not being vaccinated.

‘So we need to think about all these issues, we probably will give the Government a range of options.’ 

Public Health England data published yesterday showed that 10 to 19-year-olds had the highest infection rate in the last week of May, with 72 cases per 100,000 people and rising.

This was ahead of 52 per 100,000 in the next worst-affected group, people in their 20s, who had seen a 65 per cent surge in that week.

And separate figures show that the Indian variant is fuelling outbreaks in schools, with 97 clusters definitively triggered by the strain in the last month and potentially many more.

Although children are unlikely to get severely ill and die of coronavirus, how they are affected by long Covid still remains to be seen and it is possible they face long-term health effects that aren’t obvious when they first get infected.

Speaking about today’s approval, a Department of Health spokesperson said: ‘The government has asked the independent experts at the JCVI to advise whether routine vaccination should be offered to younger people aged 12 to 17.

‘We will be guided by the expert advisors and will update in due course.’

Professor Punir Mohammed, chair of the Commission on Human Medicines which conducted the review alongside the MHRA, added: ‘We have concluded that based on the data we have seen on the quality, effectiveness and safety of the vaccine, its benefits do outweigh any risk.

‘Over 2,000 children aged 12-15 years were studied as part of the randomised, placebo-controlled clinical trials. 

‘There were no cases of Covid-19 from seven days after the second dose in the vaccinated group, compared with 16 cases in the placebo group. 

‘In addition, data on neutralising antibodies showed the vaccine working at the same level as seen in adults aged 16-25 years. These are extremely positive results.’ 

It comes after the Pfizer jab was linked to a tiny risk of heart inflammation in Israel. 

Analysis of the jab rollout there found there had been 148 cases of myocarditis, the medical name for swelling in the heart, shortly after the patient had been vaccinated.

A total of 275 cases have been spotted so far out of around five million people given the Pfizer jab in Israel, which has had one of the world’s most successful jab rollouts. The remaining 127 are thought to have happened later so a link was unclear.

This was equivalent to just 0.005 per cent of recipients, or one in 20,000 people. 

For the 148 cases ‘probably’ linked to the jab, the rate was 0.003 per cent – although half of them had other underlying health problems.

Pfizer said it had not seen a higher rate of the condition during its clinical trials than would be expected in the general population.

Linking the illness to the vaccine is complicated because it often causes no symptoms and goes away on its own, and it can be caused by viral infection so coronavirus could cause it rather than the jab. 

Men aged 16 to 30 made up the vast majority of cases, Israel’s Health Ministry said, but 95 per cent of them had mild cases. Two patients in the group died. 

Israel is still pressing ahead with plans to vaccinate children aged 12 to 16, after its pandemic co-ordinator said the risk from the virus outweighed any concerns over the jab.

The warning is one of the first health concerns linked to the Pfizer vaccine, which was not caught up in the blood clot scare with the AstraZeneca and Johnson & Johnson jabs because it works differently. 

Israeli health officials first raised concerns Pfizer’s jab could trigger heart problems in April after detecting 60 cases, mostly among young men.

The US-based Centres for Disease Prevention and Control (CDC) launched an investigation into the issue last month.

But it said monitoring had not picked up a higher number of cases of the condition among those who had been vaccinated than would be expected normally.

The UK’s medical regulators have not raised any concerns about health issues among people who have had the jab.

And the European Medicines Agency (EMA) said last week it had not found higher rates of heart problems among those who got the jab compared to the general population, adding young men were particularly prone to the condition.

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