Influenza Virus Vaccine, Trivalent, Types A and B (chromatograph- and filter-purified subvirion antigen) - FluShield
Status: withdrawn from the market
Organizations involved:
Wyeth – Manuf.; R&D; Tech.; World mark.; Former
American Home Products Corp. – Former
New York Blood Center – Tech.
Cross ref: See the Influenza Virus Vaccines entry (#470).
Description: FluShield was a conventional injectable trivalent split (sub-virion) influenza virus vaccine. FluShield was supplied in multiple use vials containing 5 mL, and in packages of ten TUBEX Sterile Cartridge-Needle Units (disposable syringes) each containing a single 0.5 mL dose. FluShield contained 1:10,000 thimerosal, a mercury derivative, as an antimicrobial preservative (see #939).
Nomenclature: Influenza Vaccine/Wyeth [BIO]; FluShield [TR]; Influenza Virus Vaccine [FDA USAN]; Influenza Virus Vaccine, Trivalent, Types A and B (chromatograph- and filter-purified subvirion antigen) [FDA full name on 1999-2000 insert/labeling]; Influenza Virus Vaccine USP [USP]; NDC 0008-0982-01; NDC 0008-0982-02 [NDC]
Companies.: The vaccine was manufactured and marketed by Wyeth Laboratories, Inc., FDA CBER est. lic. no. 0003. Wyeth has closed and sold its Marietta, PA, facilities where this and other older vaccines were manufactured.
Manufacture: FluShield was manufactured from influenza viruses cultured in the allantoic fluid of fertile chicken embryos (eggs). The fluid was harvested, concentrated, and purified by a column chromatography procedure. Tri(n)butyl phosphate (TNBP) and Polysorbate 80, USP were added to the column eluate to effect both solvent detergent viral inactivation and disruption of a significant portion of virus to smaller subunit particles. The recovered subvirion (split-virus) suspension was subjected to dialysis to remove the inactivation/disruption agents, and further purified by filtration through membranes of controlled pore size. The final bulk was standardized by immunodiffusion assays. Not more than 5 µg/mL of the antibiotic gentamicin was added during processing. Gentamicin was not detectable in the final product.
FDA class: Biologic PLA
CBER class: Viral And Rickettsial Vaccines
Approvals: Date = 19611213; first approval, PLA
Indications: see the other influenza vaccine entries.
Status: In Nov. 2002, Wyeth announced it was finishing out the 2002-2003 flu season, halting future manufacture of Flu-Shield, and would subsequently exclusively market FluMist, a live intranasal influenza vaccine (#190, #191), (but Wyeth dropped marketing of FluMist after a disastrous product launch in the 2003-4 flu season). Wyeth manufactured about 20 million doses for the 2002-2003 flu season, but sold only about 14 million. The product license was voluntarily revoked in 2003.
Tech. transfer: Solvent detergent viral inactivation technology was developed by and presumably nonexclusively licensed from the New York Blood Center. For example, see U.S. patent 4,820,805. See the entry for Pooled Plasma, Solvent Detergent Treated (SD Plasma) (#799) for further information about solvent detergent viral inactivation, used primarily for inactivation of enveloped viruses.
Market: The National Immunization Program, Centers for Disease Control and Prevention (CDC), reported (Dec. 2000) that it purchased the vaccine in bulk for $2.365/dose (contract ending 1/31/01).
Companies involvement:
Full monograph
480 Influenza Vaccine/Wyeth
Nomenclature:
Influenza Vaccine/Wyeth [BIO]
FluShield [TR]
Influenza Virus Vaccine [FDA USAN]
Influenza Virus Vaccine, Trivalent, Types A and B (chromatograph- and filter-purified subvirion antigen) [FDA full name on 1999-2000 insert/labeling]
Influenza Virus Vaccine USP [USP]
NDC 0008-0982-01; NDC 0008-0982-02 [NDC]
FDA Class: Biologic PLA
Year of approval (FDA) = 1961
Date of 1st FDA approval = 19611213
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
chicken source materials
vaccines, inactivated
vaccines, subunit
vaccines, viral
allantoic fluid
chicken embryo (egg) culture
influenza virus
virus culture
ethyl ether
gentamicin (gentamycin)
hemagglutinin (HA) antigen, influenza A virus
polysorbate 80 (Tween 80)
thimerosal (mercury derivative)
tri-n-butyl phosphate (TNBP)
viral inactivation, solvent detergent
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
EU000 Not yet/Never filed with EU
UM999 Not Available/Not Marketed in US
US011 Approved Formerly in US/withdrawn
EM999 Not Available/Not Marketed in EU
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