Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) shared new data from their Phase 3 study of the Comirnaty vaccine, concluding that two 30-µg doses were 100% effective against COVID-19 between seven days and four months after the second dose.
The safety profile of the vaccine in the study was broadly consistent with other clinical safety data. In addition, clinical trial investigators reported no serious safety concerns in participants in the six months following receipt of the second dose.
Data from 2,228 individuals were included in the analysis.
In the U.S., the Comirnaty vaccine is available under emergency use authorization for adolescents 12 to 15. The FDA approved the vaccine for individuals at least 16 years of age in August. In late October, the companies received emergency use authorization for the vaccine in children 5 to 11.
Pfizer and BioNTech plan on including the recent data in a planned supplemental Biologics License Application (sBLA) to extend approval of the vaccine to include individuals 12 and older.
Pfizer and BioNTech received permission from the FDA to allow the use of their vaccine as a booster in all individuals 18 and older at least six months after receiving the second dose of the vaccine.
Given the expanding use of the Comirnaty vaccine, SVB Leerink analyst Geoffrey Porges recently projected that it would generate global sales of up to $59 billion in 2021 and $48 billion in 2022.
Filed Under: clinical trials, Drug Discovery, Infectious Disease