On 31 March 2021, Pfizer and BioNTech released top-line data from their phase 3 clinical trial showing 100% efficacy against COVID-19 in teenagers aged 12–15 years old following vaccination with Comirnaty™. A robust antibody response and tolerable side effects were consistent with those seen in adults aged 16–25.
The trial included 2,260 adolescents in the United States, with and without evidence of prior SARS-CoV-2 infection. There were 18 cases of COVID-19 in the placebo group and none in the vaccinated group. A strong antibody response was observed in a subset of adolescents one month after the second dose.
Pfizer/BioNTech plans to submit this data to regulatory authorities to expand the use of Comirnaty™ to adolescents aged 12–15. Further clinical trials have commenced in children aged 5–11 and are expected to begin in younger children aged 2–5 in early April, followed by ages 6 months–2 years old.
Immunisation Advisory Centre Clinical Director Dr Nikki Turner says: “It is no surprise to see this vaccine looking so effective in younger adolescents and the results are very promising. This data now needs to be scientifically scrutinised and well-reviewed by authorising bodies, including Medsafe. Once that is done, we should be close to being able to offer this vaccine to younger adolescents in New Zealand.
“Hopefully, with data looking this promising, we will not be too far away from being able to broaden our New Zealand COVID-19 immunisation programme to children as well. In doing so we will ensure more New Zealanders are protected individually and also, with more New Zealanders vaccinated, the more we will be in a position to reduce the risk of community spread.”