Pfizer Asks FDA To Expand Use Of Its COVID Vaccine In Kids Ages 12 To 15
By Bill Galluccio
April 9, 2021
Pfizer has asked the U.S. Food and Drug Administration for permission to start administering its coronavirus vaccine to children between the ages of 12 to 15. The filing comes after the pharmaceutical company released data that its vaccine, which it developed with German biotechnology company BioNTech, was 100% effective in teenagers.
The two companies said they will file the same request with health agencies in other countries in the coming days.
"These submissions represent a critical step in Pfizer's and BioNTech's ongoing efforts to support governments in broadening global vaccination efforts. 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," the companies said in a joint statement.
The FDA has not said when it will make the decision to give the vaccine to adolescents, but Pfizer CEO Albert Bourla said he hopes vaccinations can begin by the start of the new school year this fall.
The two companies also began a trial in March to test the safety and efficacy of the vaccine in children between the ages of 6 months to 11 years old.
Pfizer's vaccine is the only one authorized in the United States for people between the ages of 16 to 18. The vaccines made by Moderna and Johnson & Johnson are both authorized for adults over the age of 18.
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