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The company announced that it is asking the Food and Drug Administration to amend its emergency use authorization, which was granted for people ages 16 and up late last year.
Now, Pfizer is looking to expand its usage to adolescents as they work to get students back to full in-person learning for the fall semester.
Clinical trials of the Pfizer/BioNTech’s COVID-19 vaccine have shown that it has a 100 percent efficacy in adolescents and is well-tolerated in minors between the ages of 12 and 15, paving the way for distribution, the companies announced in March.
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.
“These submissions represent a critical step in Pfizer’s and BioNTech’s ongoing efforts to support governments in broadening global vaccination efforts," researchers said about expanding usage.
”The companies look forward to working closely with the U.S. Food and Drug Administration (FDA) and other worldwide regulatory authorities as part of the companies’ efforts to expand emergency or conditional authorization of their COVID-19 vaccine in 12- to 15-year-olds as quickly as possible.”
While more than 66 million Americans have received two doses, more than a third of the country’s population, approximately 112 million, has received at least one dose, according to data published Thursday, April 8, by the US Centers for Disease Control and Prevention.
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