EU approves Pfizer's Covid vaccine for five to 11-year-olds as continent battles ferocious fourth wave that 'could kill 700,000 Europeans this winter'
- European Medicines Agency has approved Pfizer's jab in five- to 11-year-olds
- At least one country facing spiking infections did not wait for the EMA approval
- Children in the age group have already started receiving jabs in Austria
Children as young as five are set to be given the Pfizer Covid vaccine in Europe after the EU's drug regulator approved the company's jab for the age group.
The move appears to be a direct response to the fourth wave sweeping across the continent and sending nations back into draconian lockdowns.
It is the first time the European Medicines Agency has cleared a Covid vaccine for use in children below the age of 11. Britain's vaccine rollout remains unaffected by the move, with children having to be at least 12 to receive a shot in the UK.
The agency said it 'recommended granting an extension of indication for the Covid vaccine to include use in children aged 5 to 11'.
Authorities in Austria — which is currently in lockdown and has the worst case rate in Europe — already began jabbing children in the age group before the EMA approval.
It comes after the European Centre for Disease prevention and Control (ECDC) yesterday announced third vaccine booster doses should be dished out to all adults on the continent, in a dramatic U-turn.
Europe is currently at the epicentre of the pandemic and the World Health Organization warned the continent could see 700,000 more Covid deaths by the spring unless urgent measures are taken.
Approval comes despite ongoing concerns about a rare type of heart inflammation known as myocarditis spotted in around one in 24,000 children aged 12 to 15 after two doses of Pfizer's jab.
The EU's drug regulator today approved Pfizer's Covid vaccine for children aged five to 11. Pictured: Hartford Hospital in Connecticut, US, vaccinated six children minutes after the CDC officially signed off on approval of the use of the Covid vaccine for for five to 11-year-olds on November 3
Fears over a very rare heart condition side effect — called myocarditis — led No10's vaccine advisers, the Joint Committee on Vaccination and Immunisation (JCVI), to opt against routinely jabbing healthy 12 to 15-year-olds, who face a tiny risk of getting seriously ill from the virus. It said the risk of healthy children being admitted to ICU from Covid was two in a million, rising to 100 per million among those with underlying conditions. Meanwhile, there would be three to 17 cases of myocarditis for every first dose dished out and 21 to 42 cases following each second dose given to under-16s
Just 62 per 100,000 people in England would be hospitalised if they were exposed to Covid with no further restrictions put in place, according to research by the London School of Hygiene and Tropical Medicine. It has the lowest expected admissions in Europe thanks to its successful vaccine rollout and high levels of prior infection
The number of Covid intensive care in-patients in European countries like Belgium, Germany, the Netherlands and France are on the rise and heading into levels not seen since the start of the year. In comparison the UK's number of patients requiring intensive care is levelling off
Austria has the highest Covid cases per million people in Europe, followed by the Netherlands, Belgium and Ireland
The UK's booster drive has steamed ahead of others on the continent. More than 20 per cent of Brits have now got a booster, which is almost double the level in Austria
Earlier this week, Germany's health minister Jens Spahn said shipping of vaccines for younger children in the EU would begin on December 20.
The United States signed off on Pfizer's kids-sized shots earlier this month, followed by other countries including Canada.
Professor Russell Viner, an expert in child and adolescent health at University College London (UCL) said: 'This is welcome news as it provides the option for children 5-11 years to be vaccinated against Covid in the European Union.
'Following the FDA decision in the USA and now the EMA, I suspect it would be unlikely for our MHRA not to provide a similar license in the UK.
'A license to use a vaccine in this age-group in the UK, should it eventuate, does not necessarily mean we should vaccinate all primary-school children. But it would mean that children with serious other medical conditions, who are at much higher risk from Covid, would have access to the protection from the virus that they don't currently have.
'There were no serious side-effects identified in the trial, which is excellent news and reassuring that the vaccine appears to work much as it does in teenagers and adults despite the reduced dose. However we will only be reassured about rare side effects once we have data on millions having had the vaccine.
He continued: 'It is important to recognise the very early stage of our knowledge on vaccination of children against Covid. In the normal course of things, we would rarely approve widespread use of a drug in potentially many millions of children based upon data on only a few thousand.
'Yet the pandemic has challenged our business as usual. We will have decisions ahead about vaccinating children with other medical conditions and healthy children.
'Decisions on the first group will be easier. The second set of decisions around vaccinating healthy children will need to balance the risks and benefits to the child and consider the ethical issues of vaccinating children to benefit broader society.
'The challenge will be to take a considered view which puts the rights of the child first, within a rapid time-scale. We will soon have data on over a million children vaccinated in the USA to help in our deliberations.'
Pfizer tested a dose that is a third of the amount given to adults for elementary school-age children.
Even with the smaller shot, children who are five to 11 years old developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr Bill Gruber, a Pfizer senior vice president, said in September.
Earlier this month, the EMA said it began evaluating the use of Moderna's vaccine for children ages six to 11. It estimated that a decision would be made within two months.
Pfizer's own study suggested unjabbed 12 to 15-year-olds are just three per cent more likely to catch Covid compared to fully vaccinated children earlier this week
Although children mostly only get mild symptoms of Covid, some public health experts believe immunising them should be a priority to reduce the virus' continued spread, which could theoretically lead to the emergence of a dangerous new variant.
Researchers disagree on the extent to which children have influenced the course of the pandemic.
Early research suggested they did not contribute much to viral spread.
But some experts say children played a significant role this year spreading the Alpha and Delta variants.
In a statement this week, the WHO said because children and teens tend to have milder Covid disease than adults, 'it is less urgent to vaccinate them than older people, those with chronic health conditions and health workers'.
It has appealed to rich countries to stop immunising children and asked them to donate their doses immediately to poor countries who have yet to give a first vaccine dose to their health workers and vulnerable populations.
Still, WHO acknowledged that there are benefits to vaccinating children and adolescents that go beyond the immediate health benefits.
'Vaccination that decreases Covid transmission in this age group may reduce transmission from children and adolescents to older adults, and may help reduce the need for mitigation measures in schools,' WHO said.
Pfizer's own study suggested unjabbed 12 to 15-year-olds are just three per cent more likely to catch Covid compared to fully vaccinated children earlier this week.
Just 30 of around 1,100 youngsters (2.7 per cent) tested positive for the virus in the four months of the clinical study in the US last winter.
None of the children were hospitalised or died from the virus and they were either asymptomatic or had a very mild illness.
In the group of around 1,100 youngsters that were given two doses of the vaccine, none tested positive for the virus.
Vaccinating children remains a contentious issue among some parents and by November 14 just 38.4 per cent of 12 to 15-year-olds in England were vaccinated.
Pfizer monitored 2,228 children, half of whom were given two injections of its vaccine — a 30 microgram dose, the same dose given to adults — three weeks apart, while the other group received a placebo jab.
It said its vaccine has an efficacy rate of 100 per cent, because no one who had the jab tested positive between seven days and four months after their second dose.
And the jab worked well among all children, regardless of their gender, race, weight or underlying health conditions.
Meanwhile, 30 children who were not given the jab tested positive.
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