The pair said the study, which included 2,260 children between the ages of 12 and 15, showed not only 100% efficacy from the BNT162b2 vaccine, but also a robust antibody response. Pfizer said the data exceeded results from a trial of 16 to 26 year olds, and said it will submit the figures to the U.S. Food and Drug Administration in hopes of receiving approval for the expansion of its vaccine cohort.
“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 Pfizer CEO Albert Bourla. “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.”
Pfizer shares were marked 0.8% higher in pre-market trading immediately following publication of the trial results, indicating an opening bell price of $36.40 each. BioNTech's U.S.-listed shares, meanwhile, were last seen 2.6% higher at $107.17 each.
Pfizer said last week that it would start trials of BNT162b2 on children under the age of 12 later this year, with the aim of administering doses in early 2022.
Pfizer and BioNTech said the trial will involve 144 participants who will receive different dosage levels of the two-shot vaccine over a four-week period. The trial will then be expanded to around 4,500 participants once safety and tolerance data is confirmed.