Pfizer’s COVID jab is first in EU to be approved for 12-15 year olds

A 13 year-old child receives his first dose of the Pfizer-BioNTech vaccine on Thursday, May 13, 2021, after it was approved for use in the US for 12-15 year-olds.
A 13 year-old child receives his first dose of the Pfizer-BioNTech vaccine on Thursday, May 13, 2021, after it was approved for use in the US for 12-15 year-olds. Copyright Chris Dillmann/AP
Copyright Chris Dillmann/AP
By Christopher Pitchers
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The European Medicines Agency gave the green light to member states to use the Pfizer/BioNTech vaccine against COVID-19 in children between the age of 12 and 15.


The Pfizer/BioNTech vaccine has become the first COVID jab in the European Union to be approved for use in children aged 12-15.

Before now, inoculations against COVID-19 had only been available to those aged 16 and above.

"The European Medicines Agency’s (EMA) human medicines committee has today approved the use of the vaccine from Pfizer/BioNTech called Comirnaty for adolescents from 12 to 15 years old," said Marco Caveleri, Head of Biological Health Threats and Vaccines Strategy). "The vaccine was already authorised in people from the age of 16 and above and now we have data that shows that the vaccine is safe in the age of 12 to 15 years."

The EMA, which is in charge of the evaluation and supervision of medicinal products in the EU, concluded that the benefits of Pfizer's shot in this age group outweigh the risks, but it also said that due to the limited number of children included in the study, the trial could not have detected rare side effects.

Stella Kyriakides the European Commissioner for Health has welcomed the EMA's decision, tweeting on Friday: "I welcome @EMA_News opinion on approving the BioNTech/Pfizer vaccine for 12-15 year olds. Beyond the decisions of governments, this is ultimately a decision to be made by parents for their children. Every step we take together brings us one step closer to ending the pandemic."

The EU is not the first major western power to allow youngsters to get the jab. Earlier this month, the United States approved the Pfizer/BioNTech for emergency use in 12 to 15 year-olds, where the country's Food and Drug Administration said that the benefits outweighed the potential risks.

However, in mid-May, the World Health Organization director-general Tedros Adhanom Ghebreyesus said that countries that are already vaccinating youngsters should stop doing so since they are less vulnerable to the disease.

He said instead that these doses should be donated to poorer countries through the organisation's COVAX initiative aimed at equitable access to COVID-19 vaccines.

Pfizer is due to start further trials for use of its shot in younger children, with Moderna also expected to apply for approval of using its jab in adolescents.

The EMA's findings will now be passed on to the European Commission, which will then issue a formal decision that applies legally to all 27 member states.

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