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EU regulator gives go-ahead to first COVID shot for 5-11 year olds

WorldNov 25, 2021 01:16PM ET
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© Reuters. FILE PHOTO: A health worker receives a dose of the Pfizer-BioNTech COVID-19 vaccine in Madrid, Spain, February 4, 2021. REUTERS/Sergio Perez

By Pushkala Aripaka

(Reuters) -The EU's drug regulator approved the use of Pfizer-BioNTech's COVID-19 vaccine for children between the ages of five and 11 on Thursday, paving the way for them to be given a first shot as Europe struggles with a surge in cases.

The European Medicines Agency (EMA) recommended that Pfizer-BioNTech's vaccine, approved for European Union use in teenagers between 12 and 17 years old since May, be given as an injection in the upper arm in two 10 microgram doses, three weeks apart. Adult doses contain 30 micrograms.

The approval comes as Europe is again the epicentre of the pandemic again https://reut.rs/32yJp0j, accounting for about half of cases and deaths.

Inoculating children and young people, who can unwittingly transmit COVID-19 to others, is considered a critical step towards taming the pandemic. In Germany and the Netherlands, kids now account for the majority of cases.

Pfizer (NYSE:PFE) and BioNTech have said their vaccine, which is called Comirnaty, showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.

"The benefits of Comirnaty in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19," the EMA said https://www.ema.europa.eu/en/news/comirnaty-covid-19-vaccine-ema-recommends-approval-children-aged-5-11.

While final approval is up to the European Commission, it typically follows EMA recommendations and an EU source told Reuters that a decision would likely come on Friday.

"Today's recommendation (...) is clear the BioNTech-Pfizer vaccine is safe and effective for young children, and can offer them additional protection," EU health commissioner Stella Kyriakides said on Twitter (NYSE:TWTR).

EU countries, including Austria, Poland, Hungary and the Czech Republic are now preparing nationwide inoculation programmes for younger children, although the first of the low-dose paediatric shots will not be delivered until Dec. 20.

Portugal's President Marcelo Rebelo de Sousa welcomed the "good news", noting the rising number of infections among unvaccinated children.

In France, where the number of infections is doubling every 11 days, Health Minister Olivier Veran said he would ask health regulators to examine whether 5- to 11-year-olds should be able to be given the vaccine.

Norway was considering limiting its use to kids with serious underlying conditions, such as cancer and transplant patients, Geir Bukholm, infection control director of the Norwegian Institute of Public Health (NIPH), told Reuters.

The EU joins a growing number of countries https://reut.rs/3COxM1t, including the United States, Canada, Israel, China and Saudi Arabia, which have cleared vaccines for children in the 5-11 year age group and younger.

Tens of millions of children in this age group will be eligible for the shot in the EU. Germany will get 2.4 million doses with the first shipment, enough to inoculate about half the country's children aged 5-11, a BioNTech spokeswoman said.

Polish Health Ministry spokesman Wojciech Andrusiewicz told Reuters the country is expecting a first batch of 1.1 million doses for the younger age group in December.

The Czech Republic said it expects to get 300,000 doses, which would cover about a fifth of its younger population.

In Austria, where the government has reimposed https://www.reuters.com/world/europe/austria-reimposes-full-lockdown-makes-vaccination-compulsory-2021-11-19 a nationwide lockdown, some provinces started vaccinating children of that age earlier this month even without official EMA approval.

After Thursday's announcement, Austrian Health Minister Wolfgang Mueckstein said the government would now prepare for a nationwide programme.

EPICENTRE AGAIN

Surging cases in Europe have prompted new unpopular curbs on movement https://reut.rs/3nPYov1 as winter grips the region and people gather indoors for celebrations in the run-up to Christmas, providing perfect conditions for COVID-19 to spread.

Slovakia started a two-week lockdown https://www.reuters.com/world/europe/europe-rethinks-booster-shot-policy-covid-cases-hit-records-2021-11-24 on Thursday, following the lead of Austria, while the Portuguese and French governments are considering more restrictions.

While health experts have pushed the wider use of booster shots to try and avoid hospitals being overwhelmed as immunity from earlier shots wanes, vaccinating younger people is another tool in fighting the virus.

However, the World Health Organization said on Wednesday that as children and adolescents are at lower risk of severe COVID-19, countries should prioritise adults and sharing doses with the COVAX programme aimed at supplying the world's poorest countries which have struggled to get vaccines.

Some countries have limited the use of COVID-19 shots based on the so-called mRNA technology used by Pfizer-BioNTech to younger people after reports of possible rare cardiovascular side-effects.

Top U.S. infectious disease official Anthony Fauci told Reuters this week there had been no sign of any new safety issues since the rollout of vaccines for younger kids started earlier this month.

At least 10% of the 28 million eligible U.S. children have had a first dose.

No serious safety concerns related to the vaccine have been identified in trials, Pfizer and BioNTech said in a statement.

Some medics reacted with caution, saying that as children may not get as sick as adults, there was less urgency.

"There is great public, political, and social pressure for school children to be vaccinated to avoid outbreaks in schools, but the safeguarding of public health cannot be taken based on 'guessing'," Ana Rita Cavaco, head of Portugal's nurses association, said.

EU regulator gives go-ahead to first COVID shot for 5-11 year olds
 

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Comments (9)
Forex Harbingers
Forex Harbingers Nov 25, 2021 2:57PM ET
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It doesnt matter what adults refuse. In the end, the children and our future generations are the target.
Matt Brackley
Matt Brackley Nov 25, 2021 1:36PM ET
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population control?
Todd Gray
Todd Gray Nov 25, 2021 1:26PM ET
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This is the only vaccine ever forced on kids for a "virus" that can NEVER be cured. All the other vaccines given kids have been for curable "diseases".
Dave Jones
Dave Jones Nov 25, 2021 1:24PM ET
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and now they want to come for the children
Todd Gray
Todd Gray Nov 25, 2021 1:19PM ET
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Eligible!, as in - it's a privilege? Like ice cream after completing your chores! All those kids could end up with serious consequences from the vaccine. But, that would be good for the health sector. What! Are those caring liberal healers farming for future income? They say the German people followed Adolf to be eligible to fit in with the crazies they were among.
Jo Pa
Jo Pa Nov 25, 2021 12:20PM ET
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Those who can convince you of absurdities, can convince you to commit atrocities.
Allatra Yiveh
AllatraYiveh Nov 25, 2021 12:05PM ET
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Have they ever show the study and justification of vaccination risk vs COVID-19 death on children age 5-11 (because both vax and unvax can still spread the virus equally likely)?
Felipe Daniel
Felipe Daniel Nov 25, 2021 9:59AM ET
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What is the risk of children for Covid?
Jo Pa
Jo Pa Nov 25, 2021 9:59AM ET
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Not a single known case of a child dying from covid, only with covid.
Bob Collins
Bob Collins Nov 25, 2021 9:31AM ET
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How many children must they harm? How many will die from the vaccines before the mothers rise up and this madness ends?
 
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