Covid: EU approves Pfizer-BioNTech's vaccine for children aged 12 to 15

Pfizer-BioNTech shot is first to be authorised for children by EU regulators

A 12-year-old boy is given the Pfizer-BioNTech Covid-19 vaccine in California after the US approved it for children. AP

EU regulators have cleared the way for children to be immunised against Covid-19 after the Pfizer-BioNTech shot was approved for adolescents aged 12 to 15.

The decision by the European Medicines Agency makes the vaccine the first in Europe to be approved for anyone under 16 years of age, and follows a similar move by US regulators.

Marco Cavaleri, the EMA’s head of vaccine strategy, said data showed the vaccine was safe for the younger age group.

In a study involving 2,000 adolescents in the US, none of those who received the vaccine developed Covid-19 compared with 16 in a control group, Dr Cavaleri said.

“Extending the protection of a safe and effective vaccine in this younger population is an important step forward in the fight against this pandemic,” he said.

Children should receive the same dosing regime as adults with two doses spaced at least 21 days apart, he said.

Researchers will continue to monitor the Pfizer-BioNTech shot’s efficacy and and safety in children for another two years.

The Moderna, AstraZeneca and Johnson & Johnson shots are authorised only for use in adults.

Moderna is seeking a similar approval for children aged 12 to 15 after a trial showed its vaccine was 96 per cent effective in that age group.

In a separate trial, Moderna is testing its vaccine on children aged between six months and 12 years.

Participants in that trial were given their first doses in March and the results have yet to be reported.

It will be up to the governments of the EU’s 27 member states whether to go ahead with vaccinating children.

German Chancellor Angela Merkel said vaccines would be offered to children but vaccination would not become mandatory for school attendance.

“We will be able to make every citizen including children a vaccination offer by the end of summer,” she said.

Immunising children is seen as a central step towards achieving herd immunity in the fight against the pandemic.

But the head of the World Health Organisation said this month that wealthy countries should donate spare doses to the global Covax programme instead of giving them to children.

“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,” Dr Tedros Adhanom Ghebreyesus said.