Pfizer and BioNTech decide to file for Food and Drug Administration emergency authorization in November for his or her COVID-19 vaccine in children than 5 years old, Pfizer’s Chief financial officer Frank D’Amelio said.
Pfizer has previously said the corporate expects to enter 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” the filing of the info for the 5 to the 11 year-olds, goodbye as all the data is positive.
D’Amelio said the corporate expects to possess data for the 5-11-year-old group by the top of September. Data for the even younger group is predicted later in October, he said.
Once the appliance is submitted, the supply of the vaccine in children will depend upon the speed of FDA review. Former FDA commissioner Scott Gottlieb has suggested the review could take between four and 6 weeks, while Reuters reported it might be as short as three weeks.
Pfizer-BioNTech’s vaccine has been currently authorized for youngsters aged 12 to fifteen within us , and is fully approved for people over 16.
The FDA is struggling to authorize a vaccine in children younger than 12, as many parents say they’re anxious to urge their children vaccinated as schools reopen, and therefore the highly contagious delta variant continues to spread.