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EU medicines regulator approves Pfizer Covid vaccine for children aged 12-15

The decision needs to be rubber-stamped by the European Commission and individual national regulators.

THE EUROPEAN MEDICINES Agency (EMA) has recommended the use of the Pfizer/BioNTech Covid-19 vaccine be expanded to children aged 12 to 15.

Marco Cavaleri, who heads the EMA, said the European Union regulator had received the necessary data to authorise the vaccine for younger teenagers and found it to be highly effective against Covid-19.

The decision needs to be rubber-stamped by the European Commission and individual national regulators, he said.

The recommendation follows similar decisions by regulators in Canada and the US last month, as rich countries slowly approach their vaccination targets for adults.

The Pfizer/BioNTech vaccine was the first one granted authorisation across the EU when it was licensed for use in anyone 16 and over in December.

A 79-year-old Dublin woman became the first to receive a Covid-19 vaccine in the Republic of Ireland on 29 December last year. 

The EMA’s recommendation was based on a study in more than 2,000 adolescents in the US that showed the vaccine was safe and effective.

Researchers will continue to monitor the vaccine’s long-term protection and safety in the children for another two years.

Most Covid-19 vaccines worldwide have been authorised for adults, who are at higher risk of severe disease and death from the coronavirus, but vaccinating children of all ages could be critical to stopping outbreaks, since some research has shown older children may play a role in spreading the virus even though they do not typically fall seriously ill.

In the US, children represent about 14% of the country’s coronavirus cases and at least 316 have died, according to the American Academy of Paediatrics. Doctors have also identified a rare inflammatory syndrome in a very small proportion of children suffering with Covid-19.

Vaccinating children against Covid-19 might also give authorities more confidence to keep schools open, as getting children to wear face masks and social distance has been challenging.

But the World Health Organization has criticised rich countries for moving on to vaccinate their younger and less at-risk populations, saying that the extremely limited number of Covid-19 vaccines should be shared with poor countries so they can protect their health workers and those most vulnerable.

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“I understand why some countries want to vaccinate their children and adolescents, but right now I urge them to reconsider and to instead donate vaccines to Covax,” WHO chief Tedros Adhanom Ghebreyesus said earlier this month, referring to the UN-backed initiative to distribute vaccines.

Of more than a billion Covid-19 vaccines administered globally, fewer than 2% have gone to poor countries.

Other vaccine makers are studying whether their vaccines are safe and protective in children.

Earlier this week, Moderna said its jab strongly protects children as young as 12. 

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Press Association

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