Status: approvals withdrawn; formerly a vaccine component

Organizations involved:

Lederle Labs./Wyeth – Former

Wyeth – Parent; Former

Cross ref: See the entry for Polio Vaccine Products (#516); and the entry above for Poliovirus Vaccine Live Oral Trivalent (Orimune) (#521), of which this vaccine was a component.

Description: Poliovirus Vaccine Live Oral Type I is an aqueous formulation of live attenuated poliovirus Sabin type 1 in maintenance medium. It was used only for further manufacture of Poliovirus Vaccine Live Oral Trivalent or Orimune.

Nomenclature: Poliovirus Vaccine, type 1 [BIO]; Poliovirus Vaccine Live Oral Type I [FDA]

Companies.: This type I OPV was commercially developed and manufactured by Lederle Labs./Wyeth (Pearl River, NY; formerly a subsidiary of American Cyanamid, then American Home Products Corp., now Wyeth), FDA CBER est. no. 0017.

FDA class: Biologic PLA

CBER class: Viral And Rickettsial Vaccines

Approvals: Date = 19620327, first approval, PLA

Indications: for further manufacturing use, as a component of Poliovirus Vaccine Live Oral Trivalent or Orimune

Status: FDA approval was voluntarily revoked.