Pfizer Covid vaccine is safe and effective for children aged 12 to 15, new trial data show

Findings open door to mass vaccination of schoolchildren

The Pfizer-BioNTech vaccine is safe to use and provides high levels of protection against Covid-19 in children aged 12 to 15, trial data show.

Taken from a study of 2,260 adolescents in the US, the findings raise hope that schoolchildren can start to be vaccinated against coronavirus – a major step forward that would provide coverage to more people and help to further bring the pandemic under control.

Researchers reported “robust” antibody responses in the children who were vaccinated, higher than in studies of young adults aged 16 to 25. The vaccine was 100 per cent effective in preventing symptomatic Covid-19, Pfizer added.

The preliminary data, which has yet to be peer-reviewed, showed there were no cases of Covid-19 among fully vaccinated adolescents, compared to 18 infections that were reported among participants who received the placebo.

Children had side effects similar to young adults, the company said. These include fever, chills and fatigue – particularly after the second dose. The study will continue to track volunteers for two years for more information about long-term protection and safety.

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In the UK, the Pfizer vaccine is currently licensed for use in people aged 18 and over, while a study was launched last month to assess the safety and immune response of the Oxford jab in children aged six to 17.

Johnson & Johnson is planning its own paediatric studies. And in China, Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as three.

Pfizer and its German partner BioNTech meanwhile intends to ask the US Food and Drug Administration and European regulators to allow emergency use of the vaccine starting at age 12. It is currently authorised for use in people aged 16 and over.

“We share the urgency to expand the use of our vaccine,” Albert Bourla, CEO of Pfizer, said in a statement. He expressed “hope of starting to vaccinate this age group before the start of the next school year” in the US.