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Two doses of Pfizer’s Covid vaccine is safe, effective and produces a strong immune response in five to 11-year-olds, according to trial data.
Researchers from the drug giant, working in tandem with academics at several top universities, calculated the jabs were 90.7 per cent effective at preventing infection.
Publishing the results in the prestigious New England Journal of Medicine, scientists said policies to vaccinate under-12s were ‘urgently needed’.
The US and a handful of other nations have already pressed ahead with the rollout to under-12s but the UK has yet to follow suit, despite mounting pressure from certain corners of the medical community.
Experts today warned the trial, of just 2,000 children, was too small to spot serious adverse reactions to the jab.
Dr James Doidge, a statistician based at the Intensive Care National Audit & Research Centre, called for clearer data on the precise risks and benefits on giving youngsters the jabs.
Fears over a very rare heart condition side effect — called myocarditis — led British health chiefs to opt against routinely jabbing healthy 12 to 15-year-olds, who face a tiny risk of getting seriously ill.
Eventually No10 went ahead with the move after modelling showed it would prevent tens of thousands of school absences.
But only one dose if offered to the cohort currently because myocarditis was most common after the second jab.
The Government’s vaccine advisers on the JCVI, the Joint Committee on Vaccination and Immunisation, will soon debate jabbing over-fives. But the panel, which didn’t recommend vaccinating healthy teens, is even less likely to green light the move for younger children, insiders say.
American researchers said jabs for children aged below 12 are ‘urgently needed’. Their study of more than 2,000 children, funded by Pfizer, showed the injections had a similar effect to that seen in 16 to 25-year-olds
The graphs show the side effects at the site of the injection recorded among 1,500 children who received two doses of the Pfizer jab, compared around 750 children who received two placebo injections. The researchers said all side effects relating to the arm — redness, swelling and pain — were mild to moderate and went away within two days. But those who received the Pfizer jab reported worse arm-related side effects than those who did not get the vaccine, with three-quarters of the group experiencing them
The graphs show the prevalence of other side effects — including fever, tiredness and headaches — recorded among the two groups after each dose. Overall, 10.9 per cent of children vaccinated with Pfizer reported side effects, compared to 9.2 per cent of placebo patients. Tiredness and headaches were the most common side effects. And severe fatigue (0.9 per cent), headaches (0.3 per cent) and muscle pain (0.1 per cent) were reported after the first and second dose of Pfizer’s injection. And 8.3 per cent of Pfizer recipients had a fever after the first or second jab. One person vaccinated with Pfizer had a fever exceeding 40°C two days after their second jab, but this went away the following day. No myocarditis, pericarditis or anaphylaxis was reported among any Pfizer recipients
The graph shows the number of Covid cases recorded among the five to 11-year-olds who received a placebo injection (blue line) compared to those who were double-jabbed with Pfizer (red line). Just three Covid cases were recorded among the group of 1,500 children who received Pfizer, while 16 were recorded among the 750 who got the placebo jab. The researchers used this data to calculate that the injection was 90.7 per cent effective at preventing infection
Data for children 12 to 15-year-olds showed up to one in 30,000 would be struck down with myocarditis after the second dose, according to the JCVI.
Health chiefs insist cases are mild but warn its long-term effects are still a mystery.
If the rate stood true for infants, the trial would need to be twenty times bigger for one case to be spotted.
The latest Pfizer-funded trial only gave around 1,500 children two 10μg doses — a third of the amount given to adults. It’s not clear if this will cut the risk of myocarditis because the trial was too small.
The injections, dished out between June and September in the US, Finland, Spain and Poland, were given three weeks apart.
Results were then compared to around 700 children also aged between five and 11 who weren’t given the vaccine.
Three double-jabbed children had caught Covid seven days after their second jab, compared to 16 among those who got a placebo.
Academics led by Emmanuel Walter at Duke University said the jab had a ‘favourable safety profile’ — no serious vaccine-related side effects were recorded.
Tests showed five to 11-year-olds given the jab had slightly more Covid neutralising antibodies after a month, compared to older teenagers and young adults.
In a phase 1 ‘dose-finding’ trials, which took place in March, the researchers gave 48 children aged give to 11 a 10μg, 20μg or 30μg dose of the vaccine.
The scientists selected the 10μg dose based on its immune response and the fact it had fewer side effects.
The phase two and three trial, from which today’s results were plucked from, is still administering two doses to children as young as six months.
Critics say children are better off catching Covid and getting protection naturally because the risk of being admitted to ICU is about one in 500,000, according to the JCVI.
Top scientists have said natural immunity among children means the virus is running out of people to infect and driving down cases.
But some studies have suggested myocarditis is even more common after Covid infection itself, which complicates the matter further.
Professor Jonathan Ball, a molecular virologist at the University of Nottingham, said the findings show the jab is ‘highly effective’ in young children.
He added: ‘Importantly, none of the children recruited into the trial reported serious adverse effects.
‘Whilst severe Covid is rare in young people, it can happen, and cases and ensuing isolation has severely disrupted children’s education.
The US last week approved vaccinating five to 11-year-olds with the Pfizer jab. Pictured: Christopher Reyes, nine, receives a jab at a vaccination pop-up site at on November 8 in the Lower East Side in New York City
In September, the JCVI said it could not recommend Covid jabs for healthy 12 to 15-year-olds because the direct benefit to their health was only marginal. It also looked at the risk of health inflammation – known as myocarditis – in young people given the Pfizer vaccine, which was still very small but slightly more common after a second dose
‘Vaccination is an effective way to interrupt virus spread and reduce the overall disease burden.’
Dr Doidge said: ‘Questions about the risks and benefits of vaccinated children against Covid are currently weighing heavily on the minds of most parents.
‘Unfortunately, this trial does not provide the answers we seek.
‘The reason for this is that severe outcomes of Covid among children and severe complications from vaccination are both thankfully rare – too rare to be measured even in this study of over 2,000 children.
‘All that this study tells us is the Pfizer vaccine induces a similar immune response in children and provide similar protection against infection as in adults, which was to be expected.
‘How much benefit this translates into with respect to serious illness, and at what cost that comes in terms of serious adverse reactions, will only be answered with much larger studies that are unlikely to be feasible as randomised controlled trials.’
Dr Doidge said emerging real-world data and the protection offered by previous infection should be considered to determine the likely risks and benefits of jabbing younger children.
Dr Peter English, former chair of the BMA Public Health Medicine Committee, said the trial was too small to detect rare vaccine side effects, but ‘it provides fairly good estimates of vaccine safety’.
He said: ‘Taken together with the large amount of data from countries who are already vaccinating children of this age group, the evidence is much stronger.
‘We should not procrastinate in starting to vaccinate children of this age group in the UK as we did with older children.’
But Dr English noted it was a small trial of around 2,000 children, compared to around 40,000 for the adult Pfizer trials, so is unlikely to record many Covid cases.
This means there is more uncertainty around the vaccine efficacy estimate of 90.7 per cent, so a more accurate figure would not be available until it was rolled out in the population, he said.
It comes after the US Centers of Disease Control and Prevention last week approved Pfizer’s vaccine to immunise children aged five to 11, concluding the benefits outweighed the risk.
Members of its advisory committee unanimously voted 14-0 to approve the move.
CDC director Dr Rochelle Walensky later signed off on the decision, meaning roughly 28million children in the US are now eligible for the shots.
Countries including Argentina, Bahrain, China and the UAE have even authorised Covid vaccines for under-threes.
And children aged six and older are already receiving their first doses in El Salvador, Chile, Ecuador and Indonesia.
Meanwhile, in Cuba, children as young as age two are receiving the jabs.
Professor Johnathan Van-Tam, England’s deputy chief medical officer, said last week that the UK is unlikely to follow in the US’ footsteps in the near future.
He said the US ‘are in a different position to us’ because they had already licensed the Pfizer vaccine in five to 11-year-olds.
Professor Van-Tam said: ‘I would anticipate but don’t know that the manufacturer Pfizer may well file in Europe and the UK in the next few months.
‘But that’s not a matter that I can influence in any way, it’s up to the manufacturers.
‘Then at that point, were it to be the case that the vaccine became licensed in five to 11-year-olds, there would need to be a JCVI consideration of this point.
‘But that decision is some way down the tracks and the big priority is the people who need the boosters, the partially vaccinated and unvaccinated adults. But the JCVI will get to that in due course.’
Professor Van-Tam said he is sure the JCVI ‘will be considering’ whether to follow the US.
But he said they first need to monitor the effect of the booster campaign and decide whether any other Britons should be eligible for it.
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