Pfizer and BioNTech anticipate filing with the U.S. Food and Drug Administration (FDA) for approval of their coronavirus vaccine for use in children between the ages of 6 months and 5 years in November, the company’s chief financial officer said, Frank D’Amelio industry conference on Tuesday.
Pfizer had previously announced that it would apply for US approval for vaccination for children between the ages of 5 and 11 in early October. Speaking at the Morgan Stanley Global Healthcare Conference, D’Amelio said the application for children between the ages of 6 months and 5 years will be “in the weeks shortly after the 5-11 year old data is submitted … assuming all data is positive “says Pfizers transcript his comments.
The FDA approved the BioNTech / Pfizer vaccine in late August, making it the first COVID-19 vaccine to be fully approved for use in the United States.
Both the BioNTech / Pfizer and Moderna vaccines are approved by the European Medicines Agency for children over 12 years of age.