Pfizer said the data, which showed both a high efficacy rate of 100% against COVID 19 in adolescents between 12 and 15 years of age, measured seven days through over four months after the second dose, with no serious safety concerns noted in the phase 3 trial.
Pfizer said the data will be submitted to the U.S. Food & Drug Administration for expanded approval of the vaccine, based on the Emergency Use Approval Authorization it was granted earlier this year.
Pfizer submitted data to the FDA from a late-stage trial of the 'Comirnaty' vaccine it developed with its German partner BioNTech (BNTX) - Get BioNTech SE Report, on children between the ages of 5 and 11 in late September, noting a "favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses".
“As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine’s safety and effectiveness profile in adolescents," said CEO Albert Bourla.
"This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed," he added. "We look forward to sharing these data with the FDA and other regulators."
Pfizer shares were marked 0.4% higher in early trading Monday to change hands at $505 each, a move that would extend the stock's six-month gain to around 26.2%.
Pfizer posted stronger-than-expected third quarter earnings of $1.34 per share earlier this month, and boosted its full-year profit forecast while lifting its vaccine sales estimate to around $36 billion.
Group revenues, Pfizer said, nearly doubled from last year to $24.1 billion, again topping analysts' estimates of an $22.71 billion tally. Around $13 billion of the topline came from vaccine sales, Pfizer said.
Looking into the final months of the year Pfizer said its sees adjusted earnings in the region of $4.13 to $4.18 per share, up from its prior forecast of $3.95 to $4.05 per share, on improved revenues of between $81 billion and $82 billion.