European medicines watchdog clears COVID-19 vaccine for use in 5-11 age group

Portfolio
The European Medicines Agency (EMA) recommends approval for the use of Pfizer-BioNTech's COVID-19 vaccine Comirnaty for children aged 5 to 11. Based on previous remarks by government officials, Hungary may soon start to administer the vaccine in this age group. 
oltás vakcina korona járvány

The human medicines committee (CHMP) of the European Medicines Agency (EMA) has on Thursday recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 5 to 11. The vaccine, developed by BioNTech and Pfizer, is already approved for use in adults and children aged 12 and above.

If there is a vaccine for the 5-12 age group, those affected may organise another vaccination campaign week,

said Zoltán Maruzsa, state secretary in charge of public education, earlier this week. He estimated that the approval for this age group (in fact, this is the 5-11 age group) could arrive in the following weeks.

Israel officially started to inoculate children aged 5-11 against SARS-CoV-2 on Tuesday, becoming the second country after the United States to do so.

In children from 5 to 11 years of age, the dose of Comirnaty will be lower than that used in people aged 12 and above (10 µg compared with 30 µg). As in the older age group, it is given as two injections in the muscles of the upper arm, three weeks apart.

A main study in children aged 5 to 11 showed that the immune response to Comirnaty given at a lower dose (10 µg) in this age group was comparable to that seen with the higher dose (30 µg) in 16- to 25-year-olds (as measured by the level of antibodies against SARS-CoV-2).

The efficacy of Comirnaty was calculated in almost 2,000 children from 5 to 11 years of age who had no sign of previous infection. These children received either the vaccine or a placebo (a dummy injection). Of the 1,305 children receiving the vaccine, three developed COVID-19 compared with 16 out of the 663 children who received placebo.

This means that, in this study,

the vaccine was 90.7% effective at preventing symptomatic COVID-19

(although the true rate could be between 67.7% and 98.3%).

The most common side effects in children aged 5 to 11 are similar to those in people aged 12 and above. They include pain at the injection site, tiredness, headache, redness and swelling at the site of injection, muscle pain and chills. These effects are usually mild or moderate and improve within a few days of vaccination.

The CHMP therefore concluded that 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 safety and efficacy of the vaccine in both children and adults will continue to be monitored closely as it is used in vaccination campaigns in EU Member States through the EU pharmacovigilance system and ongoing and additional studies conducted by the company and by European authorities.

The CHMP will now send its recommendation to the European Commission, which will issue a final decision.

How Comirnaty works
Comirnaty works by preparing the body to defend itself against COVID-19. It contains a molecule called messenger RNA (mRNA) which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells.

When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.

If, later on, the person comes into contact with the SARS-CoV-2 virus, their immune system will recognise it and be ready to defend the body against it.
The mRNA from the vaccine does not stay in the body but is broken down shortly after vaccination.

Cover photo: Getty Images

 

More in Economy

varga mihály mnb elnök jegybankelnök
September 18, 2025 13:37

Hungary has never had so much foreign currency reserves - What happened?

Forint buyers chill in August

4S6A0625
September 18, 2025 11:30

A digital Cold War is raging around the world, Europe may be left behind in this enormous battle

Economy Ministry State Secretary speaks at Portfolio conference

Banai Ádám
September 18, 2025 11:10

Hungary's Home Start could boost house prices 15-20% in worst case scenario - central bank

Interest subsidies not enough to ensure that companies and households take out sufficient loans

September 18, 2025 09:44

Goodbye, cash! Big changes are coming to Croatian motorways

Tolls would be paid only electronically

September 18, 2025 09:13

Spar remains profitable in Slovenia

Magyarországon komoly veszteséget hozott össze tavaly.

D_NOE20250911012
September 17, 2025 16:25

Hungarian gov't decides on supplementary pension hike

In view of inflation

LATEST NEWS
Charting is displayed using TradingView's technology, a platform, where you can build advanced charts, spot upcoming trends in the stock screener, and find inspiration in multiple trading ideas

Detailed search