Status: approvals withdrawn

Organizations involved:

Connaught Labs., Ltd. – Manuf; R&D; Tech.; Former

Connaught Laboratories, Inc. – USA mark.; Former

Cross ref: See the Polio Vaccine Products entry (#516). See the entry above for the currently marketed, improved equivalent of this vaccine from Sanofi Pasteur S.A. (France).

Description: Poliovirus Vaccine Inactivated was a sterile suspension of three strains of inactivated poliovirus: Type 1 (Mahoney), Type 2 (MEF-1) and Type 3 (Saukett) grown in a continuous monkey kidney cell line using micro-carrier culture. The viruses were concentrated, purified, and inactivated with formalin (formaldehyde in aqueous solution).

Nomenclature: Poliovirus Vaccine (IPOL)/old [BIO]; IPOL [TR]; Poliovirus Vaccine Inactivated (Monkey Kidney Cell) [FDA]; Poliomyelitis Vaccine [FDA former]; IPV [SY CDC]

Companies.: The vaccine was manufactured by Connaught Labs. Ltd. (Canada), now Sanofi Pasteur Ltd. It was marketed in the U.S. by Connaught Labs., Inc., now Sanofi Pasteur Inc.

FDA class: Biologic PLA

CBER class: Viral And Rickettsial Vaccines

Approvals: Date = 19630124; first approval, PLA, granted to Connaught Labs., Ltd.

Date = 19871120; license voluntarily revoked

Indications: active immunization of infants, children and adults for the prevention of poliomyelitis [unofficial]

Status: This vaccine was replaced in the U.S. by the current IPOL vaccine (see entry above). The culture methods and improvements in purification, concentration, and standardization of poliovirus antigen used for manufacture of the current IPOL vaccine yield a more potent and consistently immunogenic vaccine than this older inactivated poliovirus vaccine previously manufactured by the same company in Canada.

This vaccine is no longer approved or marketed in the U.S. See the entry (#518) for the Poliovirus Vaccine Inactivated (Human Diploid Cell) or Poliovax for discussion of the uncertainty of whether this newer vaccine was approved as a PLA supplement based on this older vaccine’s PLA or whether it received an original PLA.