Sept. 28 Quick Takes: Quick decision for Comirnaty with Marks at helm?
Plus Biogen, Eisai seeking approval of lecanemab for Alzheimer’s, Transcenta IPO, ViiV, Innovent-Union and more
With Peter Marks taking over as acting head of FDA’s vaccine division this week, a decision on an emergency use authorization for Comirnaty COVID-19 vaccine could come quickly now that Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have submitted data to the agency from a Phase II/III study in volunteers aged five to less than 12 years.
The antibody responses in children dosed with 10 μg were comparable to the study in people 16-25 years of age, given 30 μg dose. A formal EUA request will be submitted in coming weeks. Top-line readouts from studies in children two years to five years of age, and 6 months to two years of age are expected as soon as 4Q21...