EMA approves use of Pfizer Covid-19 vaccine for 12-15 year olds

European Medicines Agency assessment follows approval in the US

The European Medicines Agency approved the Pfizer-BioNTech Covid-19 vaccine for use in 12 to 15-year olds on Friday.

It will be the first Covid vaccine available for adolescents.

Until now, the vaccine has been approved for use in the EU in those aged 16 and over, but the regulator announced earlier this month that its Committee for Medicinal Products for Human Use had begun evaluating evidence of its safety and efficacy in younger groups.

“The CHMP concluded that the benefits of Comirnaty in this age group outweigh the risks,” the EMA said in a statement.


To come to its decision, the EMA examined the results of a trial of almost 2,000 children from 12 to 15 years of age.

Dummy injection

It found that of the 1,005 children who received the vaccine, none developed Covid-19. In comparison, 16 children out of the 978 who received a dummy injection in the trial did develop the disease.

“This means that, in this study, the vaccine was 100 per cent effective at preventing Covid-19,” the EMA said.

The side effects observed were similar to those seen in older groups, were generally mild to moderate effects that wore off within days like “pain at the injection site, tiredness, headache, muscle and joint pain, chills and fever”.

The vaccine has already been approved for emergency use in the 12-15 age group in the United States, with the Food and Drug Administration announcing on May 10th that trial data showed the benefits of the vaccine outweighed known and potential risks.

"Youngsters that belong to a risk group due to being affected by the Down syndrome, serious lung diseases like cystic fibrosis, cardiac failure or severe obesity must be vaccinated as soon as possible because they have a higher risk to have a serious condition when infected," said Peter Liese, a German MEP who is the spokesman on health for the largest group in the European Parliament.

“The question if other youngsters should be vaccinated must be discussed carefully, because although the risk for completely healthy youngsters is much lower than for elderly citizens, the risk still exists.”

German chancellor Angela Merkel said the country plans to expand Covid-19 inoculations to children aged 12 and older from June 7th. She emphasised that immunisations for children would be voluntary and wouldn't impact school participation.

Poorer countries

Earlier this month, the director general of the, World Health Organisation Dr Tedros Adhanom Ghebreyesus, appealed to countries to stop vaccinating teenagers and children, who are less at risk of serious illness from Covid-19, and instead donate doses to poorer countries where they are needed for vulnerable groups.

“In low and lower-middle income countries, Covid-19 vaccine supply has not been enough to even immunise healthcare workers, and hospitals are being inundated with people that need lifesaving care urgently,” he told a press conference.

Further trials of the Pfizer vaccine for use in younger children are due to start, and Moderna is also expected to apply for approval of its vaccine for use in teenagers.

Once the EMA reaches an opinion on a medicine, the finding is forwarded to the European Commission, which issues a formal decision that is legally applicable in all EU member states.

Naomi O’Leary

Naomi O’Leary

Naomi O’Leary is Europe Correspondent of The Irish Times