The Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100% efficacy in a Phase 3 trial in adolescents 12 to 15 years old with or without prior evidence of SARS-CoV-2 infection, Pfizer announced Wednesday.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Albert Bourla, Pfizer’s chairman and chief executive officer. “We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”
The Phase 3 trial enrolled 2,260 adolescents 12 to 15 years of age in the United States. During the study, 18 cases of COVID-19 were observed in the placebo group versus zero in the vaccinated group. Additionally, BNT162b2 demonstrated robust antibody responses, with numbers comparable to those exhibited by 16 to 25 years old in the previous trial. No harmful side effects were recorded. Minimal common effects such as soreness in the arm were again consistent with those previously observed in participants 16 to 25 years of age.
All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose, as per new CDC COVID-19 guidelines.
Pfizer and BioNTech said they plan to submit the Phase 3 trial data to the FDA and EMA as soon as possible to request an age-related expansion of the already existing Emergency Use Authorization and Conditional Marketing Authorization.
But, 12-years-old is not the youngest Pfizer intends to protect from COVID-19.
Last week, the pharma giant and its partner dosed the first healthy children in a global Phase 1/2/3 study to further evaluate the safety, tolerability and immunogenicity of the BNT162b2 vaccine in children 6 months to 11 years of age. The vaccine is being given on a two-dose schedule—approximately 21 days apart—to children across three age groups: 5 to 11 years, 2 to 5 years, and 6 months to 2 years. The 5- to 11-year-olds were dosed last week, with plans to initiate dosing in the 2- to 5-year-old group next week.
As of last Friday, transportation and storage of the Pfizer/BioNTech vaccine will be easier. Both the European Medicines Agency and the FDA have approved storage of the COVID-19 vaccine at -25°C to -15°C for two weeks. Previously, the vaccine needed to be stored at -70°C all along the cold chain, making it difficult at times for smaller entities to distribute the vaccines without ultra-low freezers—which are not common infrastructure. This set of approvals allows the vaccine to be stored at higher, common temperatures found in standard pharmaceutical freezers.