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. 

The JCVI — which normally rules who should get a vaccine — is expected to tell No10 that jabbing children is a ‘political’ decision and will leave the ball in ministers’ court. 

Vaccinating children against the virus is a controversial issue because youngsters only have a tiny risk of getting seriously ill and their immunity would likely only protect older adults. 

More than 100 cross-party MPs and the World Health Organization have said the priority should be to get vaccine doses abroad to poorer countries where vulnerable people still haven’t been jabbed before giving them to low-risk children.

More than 6million under-17s have already been vaccinated in the US after it became the first country to approve the jab for children last month. 

While Pfizer’s trials have not seen any new side effects and very few serious ones, seven American teenage boys developed heart inflammation after second dose of and were taken to hospital. 

None were critically ill, and all were healthy enough to be sent home after two to six days in the hospital. Similar reports of young men suffering inflamed hearts have emerged in Israel, too.

But pressure to vaccinate children in the UK 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. 

This afternoon Health Secretary Matt Hancock said: ‘Following a robust review of the evidence, the MHRA has concluded the Pfizer/BioNTech Covid-19 vaccine meets its high standards, authorising use for those aged 12-15. 

‘The government has asked the JCVI to advise whether routine vaccination should be offered to those aged 12-17. ‘

Dr June Raine, chief of the the Medicines and Healthcare products Regulatory Agency (MHRA) 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.’

Pfizer’s 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. 

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.

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.’ 

Critics say vaccinating children is ethically dubious because pre-teens are at such a low risk of the virus and the jabs can cause uncomfortable side effects.

There are growing calls for the plan to be ditched and for doses to be shipped to poorer nations where elderly and vulnerable people are yet to be jabbed.

Ultimately, the UK wants to achieve herd immunity – when so many people are protected against a virus, either through vaccination or previous illness, that it peters out.

Scientists disagree on what the exact herd immunity threshold is but top US medical official Dr Anthony Fauci has previously suggested it could be as high as 90 per cent.

The UK government’s Chief Scientific Advisor Sir Patrick Vallance quoted a figure of 60 per cent back in March 2020 but scientists now believe it is much higher than that because the virus is more transmissible than previously thought.

Some argue that vaccinating children is the only way to achieve herd immunity, even if the threshold is lower than the 90 per cent touted by some. 

It comes after seven teenage boys in the US developed heart inflammation after second dose of the Pfizer vaccine.

An article on seven U.S. teen boys in several states, published online Friday in Pediatrics, is among the latest reports of young men getting heart inflammation after their second COVID-19 vaccination, though a link to the vaccine has not been proven.

The boys in the study, between the ages of 14 and 19, received Pfizer shots in April or May and developed chest pain within a few days. Heart imaging tests showed a type of heart muscle inflammation called myocarditis.

None were critically ill, and all were healthy enough to be sent home after two to six days in the hospital. They are all ‘doing pretty well,’ according to Dr. Preeti Jaggi, an Emory University infectious disease specialist who co-authored the report.

She said more follow-up is needed to determine how the seven fare, but that it is likely the heart changes were temporary.

Only one of the seven boys in the Pediatrics report had evidence of a possible previous COVID-19 infection, and doctors determined none of them had a rare inflammatory condition linked with the coronavirus.

The cases echo reports from Israel in young men diagnosed after receiving Pfizer shots. 

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.