EU approves Pfizer’s Covid vaccine for five to 11-year-olds

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

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

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

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

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

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

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

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

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

Austria has the highest Covid cases per million people in Europe, followed by the Netherlands, Belgium and Ireland

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

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

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

EU says vaccine boosters should be considered for all adults 

The head of the European Union’s public health agency Andrea Ammon said on Wednesday that Covid vaccine boosters should be considered for all adults, with priority for those above 40 years, in a major change to the agency’s guidance.

Recommendations issued by the European Centre for Disease prevention and Control (ECDC) are not binding on EU governments but are used to make health policy decisions.

‘Booster doses should be considered for all adult individuals prioritising persons above 40 years of age,’ Ammon said in a recorded statement, noting that boosters should be administered at least six months after completing the primary vaccine schedule.

In its previous guidance issued in September alongside the European Medicines Agency (EMA), the ECDC said there was no urgent need for the administration of booster doses to fully vaccinated individuals in the general population, but suggested that additional doses should be considered for people with weakened immune systems and could be used as a precaution for older frail individuals.

‘Available evidence emerging from Israel and the UK shows a significant increase in protection against infection and severe disease following a booster dose in all age groups in the short term,’ the ECDC said in a report published on Wednesday.

It advised giving boosters to all adults with priority ‘for those aged 40 years and over’.

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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.

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.

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.

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

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

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 

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.

What are other countries doing about Covid vaccinations for children 

The United States starting rolling out Pfizer’s vaccines for children aged 5 to 11 at the start of the month.

A panel of outside experts met on November 2 to vote on how broadly the shot should be recommended in the age group by the US Centers for Disease Control and Prevention (CDC). 

The vaccine was authorized by the U.S. Food and Drug Administration in the age group on November 29.

But with many parts of the world still awaiting doses for more vulnerable people, the World Health Organisation has urged countries and companies that control the global supply of the vaccines to prioritize supply to COVAX.

The following is a list of some countries that have approved or are considering vaccinating children:

EU COUNTRIES

  • On November, the EU’s medicines regulator said it had approved the use of Pfizer and BioNTech’s Covid vaccine in five to 11-year-old children.
  • In June, Denmark said it would offer COVID-19 shots to children aged 12-15 to boost its overall immunity against the virus.
  • France has started vaccinating those from 12 years upwards, provided they have parental consent.
  • Germany in August agreed to make vaccination available to all children aged 12-17.
  • Austria has started vaccinating children aged 12-15.
  • Estonia could start vaccinating teenagers by the autumn, public broadcaster ERR reported, citing the head of the government’s COVID-19 council.
  • Hungary started vaccinating 16 to 18-year-olds in mid-May, according to Xinhua news agency.
  • Italy on May 31 approved extending the use of Pfizer’s vaccine to 12- to 15-year-olds. On July 28, it also endorsed the use of Moderna’s vaccine for 12- to 17-year-old children.
  • Lithuania’s prime minister said the country could start vaccinating children from age 12 in June, news site Delfi reported.
  • Spain begun vaccinating children between 12 and 17 years old around two weeks before the academic year in September, the health minister said.
  • Swedish PM says children aged 12-15 will be offered Covid vaccine later this autumn.
  • Greece in July said children aged 12-15 could be vaccinated against Covid with Pfizer/BioNTech and Moderna shots.
  • Finland’s capital Helsinki in June said it will begin giving Covid vaccines to children aged 12 to 15 who are at risk of contracting a severe coronavirus infection.
  • On July 27, Ireland lowered the age for Covid vaccination to 12 years.
  • Poland started offering Covid vaccines to children of ages 12 to 15.

EUROPE (NON-EU)

  • On October 19, UK said it will open up COVID vaccine booking service to those aged 12 to 15.
  • Switzerland approved on June 4 vaccinating 12- to 15-year-olds with Pfizer’s shot, while Moderna’s shot was approved in August for the age group.
  • In September, Norway started to offer one dose of Pfizer and BioNTech Covid vaccine to children aged 12 to 15.

MIDDLE EAST

  • In August, Israel began offering a Covid booster to children as young as 12.
  • The United Arab Emirates said in August rolled out China’s Sinopharm vaccine to children aged three to 17. On November 1, UAE approved Pfizer-BioNtech shot for children aged five to 11 for emergency use.
  • Bahrain approved Sinopharm Covid vaccine for children aged three to 11 from October 27, while on November 2, the Gulf state approved the Pfizer vaccine for emergency use for children aged between five and 11 years.

ASIA-PACIFIC

  • Indonesia on November 1 authorised China’s Sinovac vaccine for children aged 6 and above.
  • Malaysia on October 29 said it would procure the Pfizer/BioNTech vaccine for children aged five to 11, following a US expert panel’s recommendation
  • Vietnam will begin inoculating children aged 16 and 17 with parental consent from next month using the Pfizer-BioNTech vaccine.
  • An advisory committee to the Indian regulator recommended emergency use of Bharat Biotech’s Covid shot in the two to 18 age group. The regulator’s nod is awaited.
  • New Zealand’s medicines regulator in June provisionally approved use of Pfizer’s vaccine for 12- to 15-year-olds.
  • Australia said on September 12 it will expand its COVID-19 vaccination drive to include around one million children aged 12 to 15.
  • China on June 5 approved emergency use of Sinovac’s vaccine for those between three and 17.
  • Hong Kong said on June 3 it would open its vaccine scheme to children over the age of 12.
  • Singapore opened up its vaccination programme to adolescents aged 12 to 18 from June 1.
  • Japan on May 28 approved the use of Pfizer’s vaccine for those aged 12 and above.
  • The Philippines on May 26 decided to allow the Pfizer-BioNTech’s vaccine for emergency use in children aged 12 to 15.
  • Jordan in July begun vaccinating children aged 12 years and older against Covid.

AMERICAS

  • The Covid vaccine by Pfizer-BioNTech will be the only one used in Mexico for at-risk children aged 12 to 17.
  • Brazil on June 11 approved use of Pfizer’s vaccine for children over 12.
  • On September 6, Chile approved the Covid vaccine produced by China’s Sinovac Biotech Ltd for use in children over 6 years of age.
  • US FDA has authorized the Pfizer vaccine for children aged five to 11 years. CDC Director Rochelle Walensky must make her recommendations before it can be rolled out.
  • Canada in early May approved use of Pfizer’s vaccine for use in children aged 12 to 15 but the decision for children between 5 an 11 years is not likely to come before mid- to end-November.
  • Cuba’s vaccination campaign includes children as young as two.
  • On September 13, El Salvador cleared the use of COVID-19 vaccine in 6 to 11-year-old children. 
  • Argentina is vaccinating children as young as three with Sinopharm COVID-19 vaccine. 
  • Ecuador’s vaccination includes kids as young as six with the China’s Sinovac vaccine
  • Columbia is offering Pfizer, AstraZenenca, Moderna, Sinopharm and J&J’s Covid vaccines for children 12 years and above.
  • Costa Rica is vaccinating 12 years and above.

AFRICA

  • South Africa will start vaccinating children between the ages of 12 and 17 next week using the Pfizer vaccine.

Reporting by Reuters 

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