Poliovirus Vaccine Inactivated (Human Diploid Cell) - Poliovax; IPV
Status: approved but not marketed in U.S.; marketed internationally
Organizations involved:
Sanofi Pasteur Ltd. – Manuf.; R&D; Tech.
Sanofi Pasteur S.A. – Intl. mark.; Parent
Cross ref: See the Polio Vaccine Products entry (#516). See the entries for the other inactivated poliovirus vaccines, including the current U.S. inactivated vaccine.
Description: Poliovirus Vaccine Inactivated is a sterile suspension of three strains of inactivated poliovirus, Type 1 (Mahoney), Type 2 (MEF-1) and Type 3 (Saukett), grown in a continuous human diploid cell line (MRC-5) using microcarrier culture. The viruses are concentrated, purified, and inactivated with formalin (formaldehyde in solution).
Nomenclature: Poliovirus Vaccine (IPV)/Sanofi [BIO]; Poliovax [TR]; Poliovirus Vaccine Inactivated (Human Diploid Cell) [FDA]; Poliovirus Vaccine Inactivated [USAN]; Poliovirus Vaccine Inactivated USP [USP]; IPV [SY CDC]; EIPV [SY]; Enhanced IPV [SY]
Companies.: The vaccine is currently approved, but was never launched in the U.S. market. Approval for manufacture of the vaccine is held by Sanofi Pasteur Ltd. (Toronto, Canada), CBER/FDA est. no. 1726. This vaccine may be marketed internationally by Sanofi Pasteur S.A.
Manufacture: Anchorage-dependent cells, such as MRC-5, are difficult to culture in liquid media. Microcarrier culture involves use of microscopic positively-charged dextran beads suspended in culture medium to which these cells can attach, allowing large-scale culture at high concentrations.
FDA class: Biologic PLA
CBER class: Viral And Rickettsial Vaccines
Approvals: Date = 19871120; first approval (PLA) for Poliovirus Vaccine Inactivated (Human Diploid Cell) from Connaught Labs. Ltd. (now Sanofi Pasteur Ltd.) according to CBER/FDA database and other official FDA sources. However, as with a large number of pre-1980s biologics approvals, FDA has lost and/or mangled its legacy approval information. The Nov. 20, 1987 FDA approval letter reports this was approved as a PLA supplement, not an original PLA, based on the PLA for a totally different vaccine (cultured in monkey vs. human cells), Poliovirus Vaccine Inactivated (Monkey Kidney Cell) (see entry above, #517) manufactured by Connaught Labs. Ltd. (Canada; now Sanofi Pasteur Ltd.). This approval allowed for a switch from monkey kidney cells to human diploid cells for virus culture (and also a new FDA proper name). Thus, this currently approved (but not U.S. marketed) human diploid cell product appears not to have received an original approval.
Date = 2000224; approval revoked from Connaught Labs. Ltd. and reissued to new owner, Aventis Pasteur Ltd.
Indications: product insert/labeling not available; for active immunization of infants, children and adults for the prevention of poliomyelitis (polio) [unofficial]
Status: The FDA approval for this vaccine is still valid. However this vaccine was never launched in the U.S. This vaccine is currently used in Canada and many other countries. The inactivated poliovirus vaccine, IPOL, now distributed in the U.S. by Sanofi Pasteur Inc. is cultured in monkey kidney cells.
Companies involvement:
Full monograph
518 Poliovirus Vaccine (IPV)/Sanofi
Nomenclature:
Poliovirus Vaccine (IPV)/Sanofi [BIO]
Poliovax [TR]
Poliovirus Vaccine Inactivated (Human Diploid Cell) [FDA]
Poliovirus Vaccine Inactivated [USAN]
Poliomyelitis Vaccine [former USAN]
Poliovirus Vaccine Inactivated USP [USP]
EIPV [SY]
Enhanced IPV [SY]
IPV [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1987
Date of 1st FDA approval = 19871120
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
human materials used<!-- humansource -->
vaccines, inactivated
vaccines, viral
cells, human
fibroblasts, human
mammalian cell culture
microcarrier culture
MRC-5 human diploid fibroblast cells
poliovirus type 1
dextran matrix
formaldehyde
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
EU000 Not yet/Never filed with EU
UM999 Not Available/Not Marketed in US
US200 Currently Approved in US
EM001 Marketed Product in EU
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