Poliovirus Vaccine Live Oral Type I
Status: approvals withdrawn; formerly a vaccine component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.
Companies involvement:
Full monograph
522 Poliovirus Vaccine, type 1
Nomenclature:
Poliovirus Vaccine, type 1 [BIO]
Poliovirus Vaccine Live Oral Type I [FDA]
FDA Class: Biologic PLA
Year of approval (FDA) = 1962
Date of 1st FDA approval = 19620327
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
live microorganisms (as active agent)
vaccines, live
vaccines, viral
mammalian cell culture
poliovirus type 1
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
North American coral snake
EU011 Approved Formerly in EU/withdrawn
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
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