Canada authorises use of Pfizer, BioNTech's COVID-19 vaccine in younger teens

Pfizer and BioNTech said Wednesday that Health Canada expanded the authorisation for the COVID-19 vaccine BNT162b2 to include children 12 to 15 years old. The inoculation has been authorised in Canada since December for anyone 16 or older, with the latest decision marking the first country to clear a COVID-19 vaccine for use in this age group.

The FDA is also expected to authorise BNT162b2 for 12-to-15 year olds by next week, while a filing recently submitted to EU regulators is being reviewed under an accelerated assessment.

Health Canada based its decision on data from a Phase III paediatric trial that enrolled 2260 adolescents 12 to 15 years of age in the US. Topline results reported recently showed that BNT162b2 produced "robust antibody responses," with no cases of COVID-19 among vaccinated adolescents, compared with 18 among those given placebo. Side effects were also generally consistent with those observed in people 16 to 25 years of age.

Protection in time for next school year

"The department determined that this vaccine is safe and effective when used in this younger age group," remarked Supriya Sharma, a senior advisor at Canada's federal ministry. She said about one-fifth of all cases of COVID-19 in the country have occurred in children and adolescents, noting that while most do not experience serious illness, a vaccine would also help protect their friends and family who may be at higher risk of complications.

Meanwhile, Fabien Paquette, who heads the vaccines division at Pfizer's Canada unit, called the expanded authorisation "a significant step forward" in helping the country broaden its vaccination programme, and "[protecting] adolescents before the start of the next school year." Pfizer and BioNTech recently initiated another paediatric trial of BNT162b2, involving children under 12, with a data readout expected in the second half of this year.

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