NEW YORK, N.Y. — Pfizer and BioNTech announced Tuesday that they’ve made a petition for the Food and Drug Administration (FDA) to authorize their COVID-19 booster changeable for each adults.
Specifically, the companies person requested that the FDA amend the exigency usage authorization it granted for its booster dose to see each individuals 18 years of property and older.
The petition is based connected results from a Phase 3 randomized, controlled proceedings evaluating the efficacy and information of a 30-microgram booster dose of the Pfizer vaccine, according to the companies.
Under the FDA’s existent emergency usage authorization granted successful September, Pfizer’s booster dose is disposable to those 65 and older, radical betwixt 18 and 64 who are astatine a precocious hazard of terrible COVID-19, and those 18 to 64 whose predominant vulnerability to the coronavirus puts them astatine hazard of superior complications from COVID-19.
This communicative is breaking and volition beryllium updated.