EU regulators are giving the go-ahead for the first COVID shot for 5-11 year olds

  • EMA approval comes as EU battles register infections
  • USA, Canada, Israel have approved shots at younger children
  • The first EU deliveries of shots with lower doses are expected on 20 December
  • Many EU states plan nationwide inoculation programs

November 25 (Reuters) – The EU Drugs Authority 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 get a first chance while Europe struggles with an increase in cases.

The European Medicines Agency (EMA) recommended that the Pfizer-BioNTech (PFE.N) (22UAy.DE) vaccine, approved for use in the EU in adolescents between 12 and 17 years old since May, be given as an injection into the upper arm in two doses of 10 micrograms at three-week intervals. Adult doses contain 30 micrograms.

The approval comes as Europe is again the epicenter of the pandemic, accounting for about half of the cases and deaths.

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Inoculating children and adolescents, who may inadvertently transmit COVID-19 to others, is considered a critical step in taming the pandemic. In Germany and the Netherlands, children now account for most cases.

Pfizer and BioNTech have stated that their vaccine, called Comirnaty, showed 90.7% efficacy against the coronavirus in a clinical study in children aged 5 to 11 years. read more

“The benefits of Comirnaty in children aged 5 to 11 years outweigh the risks, especially in those with conditions that increase the risk of severe COVID-19,” the EMA said.

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

“Today’s recommendation (…) is clear that the BioNTech-Pfizer vaccine is safe and effective for young children, and can offer them extra protection,” EU Health Commissioner Stella Kyriakides said on Twitter.

EU countries, including Austria, Poland, Hungary and the Czech Republic, are now preparing nationwide inoculation programs for young children, although the first of the low-dose pediatric syringes will not be delivered until 20 December.

Portuguese President Marcelo Rebelo de Sousa welcomed the “good news” and noted the growing number of infections among unvaccinated children.

In France, where the number of infections doubles every 11 days, Minister of Health Olivier Veran said he would ask the health authorities to investigate whether 5- to 11-year-olds should be able to get the vaccine.

Norway is considering limiting its use to children with serious underlying conditions, such as cancer and transplant patients, says Geir Bukholm, director of infection control at the National Institute of Public Health (NIPH), to Reuters.

The EU joins a growing number of countries, including the United States, Canada, Israel, China and Saudi Arabia, which have approved vaccines for children aged 5-11 and younger. read more

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

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

The Czech Republic said it expects to receive 300,000 doses, which will cover about a fifth of the younger population.

In Austria, where the government has reintroduced a nationwide blockade, some provinces began vaccinating children of that age earlier this month, even without official EMA approval.

After Thursday’s announcement, the Austrian Minister of Health Wolfgang Mueckstein said that the government will now prepare a nationwide program.


Increasing cases in Europe have led to new unpopular curbs as winter grips the region and people gather indoors for celebrations in the run-up to Christmas, providing perfect conditions for the spread of COVID-19. read more

Slovakia started a two-week lockdown on Thursday, led by Austria, while the Portuguese and French authorities are considering several restrictions. read more

While health experts have pushed for the broader use of booster shots to try to prevent hospitals from being overwhelmed as immunity to previous shots diminishes, vaccinating younger people is another tool to fight the virus. read more

However, the World Health Organization said on Wednesday that as children and adolescents have a lower risk of severe COVID-19, countries should prioritize adults and share doses with the COVAX program, which aims to supply the world’s poorest countries that have struggled to get vaccines. read more

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

U.S. infectious disease chief Anthony Fauci told Reuters this week that there had been no sign of any new safety concerns since the rollout of vaccines for young children began earlier this month. read more

At least 10% of the 28 million eligible American children have received 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 cautiously, saying that since children may not get as sick as adults, it was less urgent.

“There is a great deal of public, political and social pressure for school children to be vaccinated to avoid outbreaks in schools, but public health cannot be taken on the basis of ‘guesswork,'” said Ana Rita Cavaco, leader of the Portuguese Nurses’ Association.

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Reporting of Pushkala Aripaka in Bengaluru; Further reporting by Francesco Guarascio in Brussels, Victoria Klesty in Oslo, Patricia Rua in Lisbon, Patricia Weiss in Frankfurt, Alan Charlish in Warsaw, Jan Lopatka in Prague and Francois Murphy in Vienna; Author by Josephine Mason; Edited by Alexander Smith

Our standards: Thomson Reuters Trust Principles.

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