Pfizer to seek US vaccine approval for children between 6 months and 5 years in November
Pfizer and BioNTech expect to apply for approval from the U.S. Food and Drug Administration (FDA) for their coronavirus vaccine for use in children between the ages of 6 months and 5 years old in November, the company’s Chief Financial Officer Frank D’Amelio told an industry conference on Tuesday.
Pfizer had previously flagged that it planned to apply for U.S. approval for the jab 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 aged between 6 months and 5 years would be filed “in the weeks shortly thereafter the filing of the data for the 5 to the 11 year-olds … assuming all of the 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 the BioNTech/Pfizer and the Moderna vaccines are authorized by the European Medicines Agency for children aged over 12 years.