EU drug regulator approves first COVID shot for 5-11 year olds By Reuters

© Reuters. FILE PHOTO: A well being employee 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 authorized using Pfizer-BioNTech’s COVID-19 vaccine for kids between the ages of 5 and 11 on Thursday, paving the way in which for them to be given a first shot as Europe battles a surge in infections.

Pfizer-BioNTech’s vaccine, which has been authorized for European Union use in youngsters between 12 and 17 years outdated since May, will likely be given in two doses of 10 micrograms three weeks aside as an injection within the higher arm, the European Medicines Agency (EMA) really helpful.

The approval comes as Europe is once more the epicentre of the pandemic once more, accounting for about half of circumstances and deaths.

The firms have stated their vaccine, which is known as Comirnaty, confirmed 90.7% efficacy towards the coronavirus in a scientific trial of youngsters aged 5 to 11. Adult doses of the vaccine comprise 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 stated

While last approval is as much as the European Commission, it usually follows EMA suggestions.

“Today’s recommendation (…) is clear the BioNTech-Pfizer vaccine is safe and effective for young children, and can offer them additional protection,” EU well being commissioner Stella Kyriakides stated on Twitter (NYSE:).

Countries won’t be able to begin rolling out the pictures amongst youthful kids till subsequent month. The first of the low-dose paediatric model will likely be delivered on Dec. 20, a spokeswoman for BioNTech stated on Thursday.

The EU joins a rising variety of nations, together with the United States, Canada, Israel, China and Saudi Arabia, which have cleared vaccines for kids within the 5-11 year age group and youthful.

Tens of thousands and thousands of youngsters on this age group will likely be eligible for the shot within the EU. Germany will get 2.Four million doses with the first cargo, sufficient to inoculate about half the nation’s kids aged 5-11, the BioNTech spokeswoman stated.

For paediatric pictures, the U.S. regulator authorised a brand new model of the vaccine, which makes use of a brand new buffer and permits them to be saved in fridges for as much as 10 weeks.


Surging circumstances in Europe have prompted new unpopular curbs on motion as winter grips the area and folks collect indoors for celebrations within the run-up to Christmas, offering good circumstances for COVID-19 to unfold.

On Thursday, Slovakia began a two-week lockdown, following the instance of neighbouring Austria, whereas the French and Portuguese governments had been contemplating extra restrictions.

Health consultants have pushed the broader use of booster pictures to attempt to keep away from hospitals being overwhelmed as immunity from earlier vaccinations wanes.

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