The company’s Chief Financial Officer, Frank D’Amelio, said that Pfizer and BioNTech are waiting to apply for approval from the US Food and Drug Administration (FDA) for the coronavirus vaccine to be used in children aged 6 months to 5 years in November. Industry conference on Tuesday.
Pfizer previously said it plans to apply for US approval for the vaccine for children ages 5 to 11 in early October. Speaking at the Morgan Stanley Global Health Conference, D’Amelio said the application for children aged 6 months to 5 years will be filed “in the weeks after data is filed for 5 to 11 year olds.” assuming all the data are positive,” says Pfizer transcript from his comments.
FDA approved The BioNTech/Pfizer vaccine’s release in late August makes it the first fully licensed COVID-19 vaccine 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.