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EMA gives green light for use of Pfizer-BioNTech COVID-19 vaccine for 12-15 year olds

DUBLIN: The EU’s drug watchdog has approved the use of the Pfizer/BioNTech COVID-19 vaccine in children aged 12 to 15 after similar clearances in the United States and Canada. This is the first vaccine approved in the European Union for this age group.

The vaccine is already being used in the EU for those aged 16 and above, but the EMA has now approved it for use in children as young as 12 after its Committee for Medicinal Products for Human Use found that the jab is highly preventive and that the benefits outweigh the risks. The regulator said the vaccine was “well tolerated” in children and there were no “major concerns” in terms of side effects.

The Pfizer/BioNTech vaccine is already approved for use in the 12-15 age group in the US and Canada. Following EMA approval, Germany said that it will begin vaccinating children aged 12 to 15 from June 7, while Italy aims to expand its vaccination program to include children of the same age.

EMA says the vaccine is 100% effective

The EMA made its decision after reviewing the results of a trial involving nearly 2,000 adolescents aged 12 to 15. According to the findings, none of the 1,005 children who received the vaccine developed COVID-19. At the same time, 16 children out of the 978 who received a dummy injection in the trial developed infection. The EMA said the study shows that the vaccine is 100% effective in preventing COVID-19 in children aged 12 to 15.

Side effects

The EMA said that the side effects of vaccine in children are similar to those seen in older groups. These include mild to moderate side effects such as injection site soreness, tiredness, headache, muscle and joint pain, chills and fever.

Peter Liese, a German MEP who is the spokesman on health for the largest group in the European Parliament, said children who are affected by the Down syndrome, serious lung diseases like cystic fibrosis, cardiac failure or severe obesity must be vaccinated as soon as possible. He warned that if these children are infected with COVID-19, they are more likely to have a serious condition.

At the same time, the German MEP said that it should be discussed further whether other children who are not affected by major health issues should be vaccinated. This is because, while the risk for healthy children is significantly smaller than for elderly people, it still exists.

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