EU approves Pfizer vaccine for children 12-15

Berlin: The European Medicines Agency on Friday recommended that the use of the coronavirus vaccine made by Pfizer and BioNTech be expanded to children ages 12 to 15, a decision that offers younger and less at-risk populations across the continent access to a COVID-19 shot for the first time during the pandemic.

Marco Cavaleri, who heads the EMA body that reviewed the vaccine, said the European Union regulator had received the necessary data to authorise the vaccine for younger teens 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 United States last month, as rich countries slowly approach their vaccination targets for adults and look to immunize as many people as possible.

The Pfizer-BioNTech COVID-19 vaccine was the first one granted authorisation across the 27-nation EU when it was licensed for use in anyone 16 and over in December.

The EMA's recommendation that the vaccine's authorization be expanded to children 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 shot'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 don't 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 Pediatrics. Doctors have also identified a rare inflammatory syndrome in a very small proportion of children sickened by COVID-19. Immunising children against COVID-19 might also give authorities more confidence to reopen schools, as getting children to wear masks and social distance has been challenging at times.

But the World Health Organisation 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 instead be shared with poor countries so they too can protect their health workers and those most vulnerable.