| 19 April 2024, Friday |

EU drug regulator approves first COVID shot for 5-11 year old

On Thursday, the European Union’s drug regulator approved the use of Pfizer-COVID-19 BioNTech’s vaccine for children aged five to eleven, paving the way for them to receive their first shot as Europe battles an outbreak of infections.

Pfizer-vaccine, BioNTech’s which has been approved for use in teenagers aged 12 to 17 in the European Union since May, will be administered in two doses of 10 micrograms three weeks apart as an injection in the upper arm, according to the European Medicines Agency (EMA).

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

The companies 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. Adult doses of the vaccine contain 30 micrograms.

“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.

While final approval is up to the European Commission, it typically follows EMA recommendations.

“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.

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

The EU joins a growing number of countries, 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, the BioNTech spokeswoman said.

For paediatric shots, the U.S. regulator authorized a new version of the vaccine, which uses a new buffer and allows them to be stored in refrigerators for up to 10 weeks.


Surging cases in Europe have prompted new unpopular curbs on movement 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. read more

On Thursday, Slovakia started a two-week lockdown, following the example of neighboring Austria, while the French and Portuguese governments were considering more restrictions.

Health experts have pushed the wider use of booster shots to try and avoid hospitals being overwhelmed as immunity from earlier vaccinations wanes.

  • Reuters