Pfizer and BioNTech plan to seek U.S. Food and Drug Administration (FDA) approval for their coronavirus vaccine for children aged 6 months to 5 years in November, the company’s chief financial officer said, Frank D’Amelio. industry conference Tuesday.
Pfizer previously reported that it planned to seek US approval for the jab for children ages 5 to 11 in early October. Speaking at the Morgan Stanley Global Healthcare conference, D’Amelio said the application for children aged 6 months to 5 years would be filed “within weeks shortly after the data was filed for the 5 to 5 years old. 11 years … assuming all data is positive, “according to Pfizer’s transcript of his comments.
The FDA approved the BioNTech / Pfizer vaccine in late August, making it the first COVID-19 vaccine to be fully licensed for use in the United States.
Both BioNTech / Pfizer and Moderna vaccines are authorized by the European Medicines Agency for children over 12 years of age.