Pfizer and BioNTech expect to apply for approval from the US Food and Drug Administration (FDA) for their coronavirus vaccine for use in children aged 6 months to 5 years in November, the company’s CFO Frank D’Amelio told an industry conference on Tuesday.
Pfizer had previously indicated that it planned to apply for U.S. approval of 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 between the ages of 6 months and 5 years would be submitted “in the weeks shortly following the submission of data for the 5 to 11-year-olds … provided all data are positive, “according to Pfizers printout 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 Moderna vaccines are approved by the European Medicines Agency for children aged 12 years.