HealthDay News – Pfizer Inc. announced Wednesday that its COVID-19 vaccine is safe and remarkably effective in children 12 years and older.
In a press release from Pfizer and its vaccine development partner BioNTech, company executives announced that data from a study of the vaccine in nearly 2,300 people between the ages of 12 and 15 will be submitted to the U.S. Food and Drug Administration over the coming weeks . The Pfizer BioNTech vaccine is now FDA approved for emergency use in people 16 years and older.
“We share the urgency to expand our vaccine approval for use in younger populations and are encouraged by data from clinical trials in adolescents aged 12-15,” said Dr. Albert Bourla, Chairman and CEO of Pfizer, in the press release. “We plan to submit this data to the FDA and other regulatory agencies around the world in the coming weeks as a proposed change to our emergency clearance in the hopes of starting vaccination for this age group before the start of the next school year.”
In the phase 3 study, the vaccine was 100 percent effective in preventing symptomatic disease within the study. 18 cases of COVID-19 in the group that received a placebo and none in the group that received the vaccine, the companies said. The vaccine triggered immune responses that were even more robust than in young adults.
Last week Pfizer-BioNTech also started a study in younger children, ages 6 months to 11 years. This study will determine a safe dose first in children ages 5 to 11, then in children ages 2 to 5, and then in children ages 6 months to 2 years, the companies say. Moderna is also conducting similar studies to test its COVID-19 vaccine in teenagers and young children. The vaccine is FDA approved for emergency use in people over the age of 18.
Pfizer press release
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