EU regulator gives go-ahead to 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 accredited the usage of 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 primary shot as Europe struggles to include a surge in infections.

The European Medicines Company (EMA) advisable that Pfizer-BioNTech’s vaccine, accredited for European Union use in youngsters between 12 and 17 years outdated since Might, be given as an injection within the higher arm in two 10 microgram doses, three weeks aside. Grownup doses include 30 micrograms.

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

Inoculating kids and younger folks, who can unwittingly transmit COVID-19 to others, is taken into account a crucial step in the direction of taming the pandemic. In Germany and the Netherlands, youngsters now account for almost all of circumstances.

Pfizer (NYSE:) and BioNTech have stated their vaccine, which is known as Comirnaty, confirmed 90.7% efficacy towards the coronavirus in a scientific trial of kids aged 5 to 11.

“The advantages of Comirnaty in kids aged 5 to 11 outweigh the dangers, notably in these with circumstances that enhance the chance of extreme COVID-19,” the EMA stated comirnaty-covid-19-vaccine-ema-recommends-approval-children-aged-5-11.

Whereas closing approval is as much as the European Fee, it usually follows EMA suggestions and an EU supply informed Reuters {that a} determination would seemingly come on Friday.

“As we speak’s suggestion (…) is evident the BioNTech-Pfizer vaccine is protected and efficient for younger kids, and might provide them further safety,” EU well being commissioner Stella Kyriakides stated on Twitter (NYSE:).

International locations will be unable to begin rolling out the pictures amongst youthful kids till subsequent month. The primary of the low-dose pediatric model will probably be delivered on Dec. 20, a spokeswoman for BioNTech stated.

Polish Well being Ministry and Wojciech Andrusiewicz informed state-run information company PAP that Poland would begin vaccinating kids aged 5-11 in December.

The EU joins a rising variety of nations, together with the USA, Canada, Israel, China and Saudi Arabia, which have cleared vaccines for kids within the 5-11 12 months age group and youthful.

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

For pediatric pictures, the US regulator licensed 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 excellent circumstances for COVID-19 to unfold.

Slovakia began a two-week lockdown on Thursday, following the lead of Austria, whereas the Portuguese and French governments are contemplating extra restrictions.

Whereas well being specialists have pushed the broader use of booster pictures to attempt to keep away from hospitals being overwhelmed as immunity from earlier pictures wanes, vaccinating youthful folks is one other software in preventing the virus.

Some nations, nevertheless, have restricted the usage of COVID-19 pictures primarily based on the so-called mRNA know-how utilized by Pfizer-BioNTech to youthful folks after experiences of attainable uncommon cardiovascular side-effects.

High US infectious illness official Anthony Fauci informed Reuters this week there had been no signal of any new issues of safety because the rollout of vaccines for youthful youngsters began earlier this month.

At the very least 10% of the 28 million eligible US kids have had a primary dose.


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