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Officials said that initial trials were fruitful, and they plan to submit the data to the U.S. Food and Drug Administration for expanded emergency use authorization of the two-dose vaccine in adolescents.
According to Pfizer, the third phase of the clinical trial included 2,260 participants between the ages of 12 and 15, which found that strong antibody responses developed within a month after the second dose was administered.
The data showed that the vaccine may even be more effective in adolescents than it is in adults between the ages of 16 and 25.
Researchers sad there were 18 COVID-19 cases among 1,129 participants who were given a placebo, and none in 1,131 volunteers who got the vaccine. The data is yet to be peer-reviewed.
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.
Currently, the Pfizer vaccine has only been approved for those who are 16 and older, though if the FDA grants emergency use authorization, the new age group could be included in upcoming vaccination plans.
According to Pfizer, the side effects in the 12 to 15 age group were minimal and similar to those seen in those between the ages of 16 and 25.
Albert Bourla, chairman and chief executive officer of Pfizer said that: “We share the urgency to expand the use of our vaccine to additional populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15.”
Pfizer plans to submit the data to the FDA in the coming weeks with the hope of starting to vaccinate younger children before the beginning of the new school year in the fall. The company also said it plans to start its trial of children 11 and under by dosing participants in the 2 to the 5-year-old range next week.
“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,” Bourla added. "With the hope of starting to vaccinate this age group before the start of the next school year."
Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children's Hospital, said on CNN's New Day Wednesday that schools will be permitted to open back up without adolescent vaccinations, though the vaccine for younger children could be helpful in the fight against COVID-19.
“The bottom line is that by the fall I think there's a good possibility we'll be vaccinating teenagers, 12 and up, and for middle schools, junior high schools, high schools, it's really good news in the United States for both teachers and staff,” he said. “We'll have teachers and staff vaccinated, we'll have the students vaccinated in those middle schools and high schools.”
BioNTech CEO Ugur Sahin added: “We are longing for a normal life,” he said in a statement. “This is especially true for our children.”
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