EU medical agency chief: Two weeks needed to study COVID-19 vaccines' effectiveness on omicron
Pfizer plans to seek vaccine authorization in November for kids under 5
Pfizer and BioNTech plan to file for Food and Drug Administration (FDA) emergency authorization in November for their COVID-19 vaccine for children younger than 5, Pfizer Chief Financial Officer Frank D'Amelio said this week.
Pfizer has previously said the company expects to file in early October for emergency use authorization in children ages 5 to 11.
Presenting during an industry conference Tuesday, D'Amelio said the company plans to file for emergency use authorization for younger kids "in a month shortly thereafter," so long as all the data is positive.
D'Amelio said the company expects to have data for the 5 to 11 group by the end of September. Data for the even younger group is expected later in October, he said.
Once the application is submitted, the availability of the vaccine in children will depend on the speed of FDA review. Former FDA Commissioner Scott Gottlieb has suggested the review could take between four and six weeks, while Reuters reported it could be as short as three weeks.
Pfizer-BioNTech's vaccine has been currently authorized for children aged 12 to 15 in the United States and is fully approved for people over 16.
The FDA is under pressure to authorize a vaccine for children younger than 12, as many parents say they are anxious to get their children vaccinated as schools reopen and the highly contagious delta variant continues to spread.