The EU regulator gives the go-ahead for the first covid injection for 5-11-year-olds

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

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  • The move comes when EU battles register infections
  • USA, Canada, Israel have approved shots at younger children
  • The first EU deliveries of lower-dose syringes are expected on 20 December

Nov 25 (Reuters) – The European Medicines Agency 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 shot as Europe struggles with an increase in cases.

The European Medicines Agency (EMA) recommended that Pfizer-BioNTechs (PFE.N)(22UAy.DE) vaccine, approved for EU use in adolescents between 12 and 17 years of age since May, is given as an 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 again the epicenter of the epidemic again, which accounts for about half of the cases and deaths.

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Inoculation of children and adolescents, who may unknowingly transmit covid-19 to others, is considered a crucial step in taming the pandemic. In Germany and the Netherlands, children now account for the majority of cases.

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

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

Although the final approval is up to the European Commission, it usually follows the EMA’s recommendations and an EU source told Reuters that a decision would probably come on Friday.

“Today’s recommendation (…) is clear that 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.

Countries will not be able to start rolling out the shots among younger children until next month. The first of the low-dose pediatric versions will be delivered on December 20, a spokeswoman for BioNTech said.

Polish Health Ministry spokesman Wojciech Andrusiewicz told the state news agency PAP that Poland would begin vaccinating children aged 5-11 in December when they receive the first batch of 1.1 million doses for the younger children.

The EU joins one growing number of countries, including the United States, Canada, Israel, China and Saudi Arabia, which have approved vaccines for children aged 5-11 years 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, BioNTech’s spokeswoman said.

The Czech government said it expects to receive 300,000 doses, which would inoculate about a fifth of its younger population.

For pediatric shots, the US regulator approved a new version of the vaccine, which uses a new buffer and allows them to be stored in the refrigerator for up to 10 weeks.

The World Health Organization said on Wednesday that because children and adolescents are at lower risk for severe covid-19, countries should prioritize adults and share doses with the COVAX program, which aims to provide the world’s poorest countries that have struggled to get vaccines. Read more


Swelling cases in Europe have caused new unpopular curbs for movement When winter grips the region and people gather indoors to celebrate before Christmas, which provides perfect conditions for covid-19 to spread. Read more

Slovakia started a two-week lockdown on Thursday, following Austrian leadership, 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 being overwhelmed when immunity to previous shots fades, vaccinating younger people is another tool to fight the virus. Read more

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

Anthony Fauci, the United States’ top infectious disease officer, told Reuters this week that there had been no sign of any new safety concerns since the launch 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.

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Reporting of Pushkala Aripaka in Bengaluru; Further reporting by Francesco Guarascio in Brussels, Patricia Weiss in Frankfurt, Alan Charlish in Warsaw and Jan Lopatka in Prague; Author of Josephine Mason; Edited by Alexander Smith

Our standards: Thomson Reuters Trust Principles.


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