EU regulator gives green light to first COVID injection for 5-11 year olds

A health worker receives a dose of the Pfizer-BioNTech COVID-19 vaccine in Madrid, Spain, Feb. 4, 2021. REUTERS/Sergio Perez

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  • Move comes as EU battles record infections
  • US, Canada and Israel have approved shot to younger children
  • First EU deliveries of lower dose injections scheduled for December 20

Nov. 25 (Reuters) – The EU drug regulator on Thursday approved the use of Pfizer-BioNTech’s COVID-19 vaccine for children between the ages of five and 11, paving the way for them to get a first chance while Europe is struggling with a wave of cases.

The European Medicines Agency (EMA) has recommended that the vaccine from Pfizer-BioNTech (PFE.N)(22UAy.DE), which has been approved for use in the European Union in the European Union since May in teenagers between 12 and 17 years old, be administered as a injection into the upper arm in two doses of 10 micrograms, three weeks apart. Adult doses contain 30 micrograms.

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

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Vaccinating children and young people, who can unknowingly transmit COVID-19 to others, is considered a critical step towards taming the pandemic. In Germany and the Netherlands, children are now responsible for the majority of cases.

Pfizer and BioNTech have said their vaccine, called Comirnaty, showed 90.7% efficacy against the coronavirus in a clinical trial of children ages 5 to 11. read more

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

While final approval is up to the European Commission, it mostly follows EMA’s recommendations and an EU source told Reuters a decision was likely to be made on Friday.

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

Countries can’t start rolling out the injections to younger children until next month. The first of the low-dose pediatric version will be delivered on Dec. 20, a BioNTech spokeswoman said.

The spokesman for the Polish Ministry of Health, Wojciech Andrusiewicz, told the state-run news agency PAP that Poland would start vaccinating children aged 5-11 in December when it receives the first batch of 1.1 million doses for the younger generation. receives children.

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

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

The Czech government said it expects 300,000 doses, which would vaccinate about a fifth of the younger population.

For pediatric injections, the US regulator approved a new version of the vaccine, which uses a new buffer and can keep them in refrigerators for up to 10 weeks.

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


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

Slovakia began a two-week lockdown on Thursday, following Austria’s lead, while the Portuguese and French governments are considering more restrictions. read more

While health experts have pushed for the wider use of booster shots to try to prevent hospitals from becoming overwhelmed as immunity from previous shots wanes, vaccinating younger people is another tool in fighting the virus. read more

However, some countries have restricted the use of COVID-19 injections based on the so-called mRNA technology used by Pfizer-BioNTech to younger people after reports of possible rare cardiovascular side effects. read more

Anthony Fauci, the US’s top infectious disease official, told Reuters this week there has been no sign of new safety concerns since the introduction of vaccines for younger children earlier this month. read more

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

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Reporting by Pushkala Aripaka in Bengaluru; Additional coverage by Francesco Guarascio in Brussels, Patricia Weiss in Frankfurt, Alan Charlish in Warsaw and Jan Lopatka in Prague; Writing by Josephine Mason; Editing by Alexander Smith

Our Standards: The Thomson Reuters Trust Principles.


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