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COVID-19 VACCINES

EU approves first Covid jab for children aged 5 to 11

The EU's drug agency cleared Pfizer's Covid-19 vaccine for use in children aged five to 11 on Thursday, the first jab to be approved in a cohort where the virus is rapidly spreading.

A child, age 8, receives the Pfizer-BioNTech Covid-19 vaccine
A child, age 8, receives the Pfizer-BioNTech Covid-19 vaccine Andrej Ivanov / AFP

Only a small handful of countries had previously given the nod for coronavirus vaccinations in younger children, including the United States, Israel and Canada.

“I’m glad to tell you that Comirnaty from today has received approval for children five to 11 years of age,” said Marco Cavaleri, head of vaccine strategy at the European Medicines Agency (EMA), using the vaccine’s brand name.

“This is based on a different dose in the one used in adults, essentially it’s a much lower dose,” he told an online public meeting.

The vaccine was already cleared for use in people aged 12 and over in the 27-nation EU.

Children aged five to 11 will be given one third of the dose that older people receive, with two injections, three weeks apart, the EMA said in a statement.

The vaccine was 90.7 percent effective in a study of nearly 2,000 children of that age, it added.

Side effects were usually “mild or moderate” lasting a few days, and included pain in the injection site, tiredness, headache, muscle pain and chills.

The EMA “therefore concluded that the benefits of Comirnaty in children aged five to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe Covid-19.”

The EU Commission will now likely approve the vaccine for children aged 5 to 11 but the ultimate decision over whether to roll out the Covid jab to yound kids will rest on the government of each member state.

France on Thursday said ministers were examining rolling out the vaccine to the age group but said there would be no decision before 2022.

But the Pfizer jab’s safety in children “will continue to be monitored closely”.

Health authorities say children make up an increasing proportion of new cases and hospitalisations in Europe, which is back at the centre of the coronavirus pandemic.

Children are also considered key drivers of infections even when they themselves do not come down with symptoms.

In the Netherlands, where the EMA is based, authorities said earlier this week that the largest increase in cases was among children up to the age of 12.

“We know that severe Covid-19 and death remain quite rare in children, however disease of all severity occurs in all the paediatric ages,” Cavaleri said.

“Moreover, high transmission results in increased hospitalisation in children of all ages.”

While children with underlying health conditions were more likely to become ill, the majority of children in hospital with Covid were otherwise healthy, said Cavaleri.

They were also at risk of so-called “long Covid” symptoms dragging on for months after infection, and multisystem inflammatory syndrome, he added.

The EMA is separately reviewing Moderna’s coronavirus vaccine for children aged 6-11 and expects to reach a decision in January.

The regulator has so far approved four vaccines for use for adults in the EU: Pfizer and Moderna, which use messenger RNA technology, and AstraZeneca and Johnson & Johnson, which use viral vector technology.

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COVID-19 VACCINES

Who is eligible for a fourth Covid vaccine dose in Denmark and when?

Public health officials in Denmark say a low turnout for the second round of Covid booster shots — for most people, their fourth jab — has made them concerned that many don’t realise they’re eligible.

Who is eligible for a fourth Covid vaccine dose in Denmark and when?

 Danish authorities have hardly clear on whether to offer fourth Covid jabs and to whom, since the beginning of 2022.

In January, the government announced that fourth shots would be given to the very elderly and other high risk populations— but that decision was reversed just four weeks later and the fourth Covid dose program was ended.

At a June 22nd press conference, Prime Minister Mette Frederiksen announced plans for a more general booster program in the autumn and added that the ‘particularly vulnerable’ would be eligible for new doses the following week. 

When the Covid vaccination program began in early 2021, Denmark estimated the number of ‘selected patients with particularly increased risk’ that should be prioritised for vaccination at 240,000. But in the month since Frederiksen’s announcement, only about 3,500 people have come in for a fourth jab. Experts say that’s in no small part over confusion as to who is ‘particularly vulnerable.’

Indeed, the Danish Health Authority website doesn’t appear to currently provide a list of conditions that qualify for a second booster and instead refers readers to their primary care provider. That’s unfortunate since even general practitioners are finding it hard to determine who the rules say can get a fourth shot, Danish broadcaster DR reports.

The failure to resolve the issue is putting many patients at risk, some public health experts worry. “With the spread we are seeing with Covid at the moment, I think the Health Authority needs to be very clear about who should get the fourth prick now and who should wait,” Torben Mogensen, chairman of the Lung Association, told DR. 

READ ALSO: Danish health minister says further Covid-19 vaccinations could ward off restriction

What we know for sure 

  • Pregnant and breastfeeding women are already eligible for fourth doses
  • People with suppressed immune systems are already eligible 
  • Approximately September 15: fourth doses begin for people in care homes and among ‘particularly vulnerable’ elderly people 
  • October 1st: fourth doses begin for everyone 50 years of age and and over 

Your primary care provider (the one on your yellow card) can refer you for a vaccination appointment, as can doctors at hospitals. 

What factors will your doctor consider? 

Guidelines provided to doctors by the Danish Health Authority ask them to weigh the patient’s age, risk of serious course of illness if infected, their presumed immunity status based on recent infection, and their overall risk of infection based on their living conditions (strangely, crowded living conditions and living in a sparsely populated area both suggest you may need a booster shot). 

…and now for the riddles

In lieu of a list of conditions that might qualify a patient for an early fourth shot, doctors have been offered a series of ‘example patients’ that are eligible for a booster  under the new rules. 

  • 45-year-old woman with reduced immune system due to haematological cancer
  • 74-year-old man with severe obesity and heart failure, who has had recurring lower respiratory tract infections for the past six months and declining functional level
  • 65-year-old woman with severe obesity and diabetes with serious co-morbidities, e.g foot ulcers or chronic kidney failure
  • 82-year-old woman with rapid onset of functional loss (e.g. failing memory, reduced mobility and need for help with personal care) and beginning signs of malnutrition (eats too little, does not gain weight)
  • 23-year-old with cystic fibrosis with frequent pneumonia and hospitalisations
  • 50-year-old male with bowel cancer who has recently completed chemotherapy
  • 85-year-old man who lives with his children and grandchildren in a small home
  • 65-year-old woman who has been operated on for breast cancer and has diabetes, and who needs to travel to an area with high infection
  • 39-year-old resident of a social psychiatric residence, with heavy tobacco consumption, occasional alcohol overconsumption, overweight and in treatment with many different drugs

READ ALSO: Danish hospitals see rise in number of Covid patients 

It’s worth a call or message 

With a particularly nasty flu season on the horizon, public health experts say it’s worth a call, email, or message to your primary care provider if you have any reason to suspect you might be eligible for vaccination. 

“We know that infection rates have been rising both in Denmark and in Europe in recent weeks, and a new variant is on its way in,” Aarhus University professor emeritus of infectious diseases told DR.  “Then comes autumn, when we know that a respiratory virus spreads more than it does in summer. So there’s every reason to get that fourth jab if you’re in the vulnerable groups and it’s been more than six months since you had your third.” 

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