Polyvalent Bacterial Vaccines with “No U.S. Standard of Potency” - MRV; Mixed Respiratory Vaccine
Status: FDA approval withdrawn
Organizations involved:
Hollister-Stier Laboratories LLC – Former
Bayer Corp. – Former
Bayer AG – Parent; Former
Cross ref: See also the entry (#405) for Polyvalent Bacterial Antigens with “No U.S. Standard of Potency.”
Description: Polyvalent Bacterial Vaccines with “No U.S. Standard of Potency” or MRV Mixed Respiratory Vaccine is an aqueous suspension of phenol inactivated whole bacteria – Staphylococcus aureus (1,200 million/mL), Streptococcus viridans and nonhemolytic strains (200 million/mL); Streptococcus pneumoniae (Diplococcus pneumoniae) (150 million/mL); Moraxella catarrhalis (Branhamella catarrhalis; Neisseria catar-rhalis) (150 million/mL); Klebsiella pneumoniae (150 million/mL); and Haemophilus influenzae (100 million/mL of type a; 150 million/mL of type b). Each mL of vaccine contains two billion inactivated bacteria in 0.9% sodium chloride solution, with 0.4 phenol as preservative. Traces of bovine (beef) brain and heart tissues, peptones, yeast extract, agar, and sheep (ovine) blood used in the culture media may act in allergens in sensitive persons. The vaccine is packaged in a 20 mL multiple-dose vial. It should be stored at 2-8˚C (refrigerated), with a shelf life of 18 months.
Nomenclature: Bacterial Antigens/Mixed [BIO]; MRV Mixed [TR]; Polyvalent Bacterial Vaccines with “No U.S. Standard of Potency” [FDA]; MRV Mixed Respiratory Vaccine [SY]; NDC 00118-9012-00 [NDC]
Biological.: The mechanism of action apparently involves potentiation of immune responses. The mechanism of action, onset of immunity, duration of immunity, and other aspects of this vaccine remain unknown.
History: Companies previously licensed to manufacture Polyvalent Bacterial Vaccines with “No U.S. Standard of Potency:” Eli Lilly & Co. (Dec. 1901-March 1978) and Parke-Davis Div., Warner-Lambert Co. (Dec. 1901-Nov. 1977).
Companies.: The vaccine was developed, manufactured and formerly marketed by the Cutter Labs. or Hollister-Stier Labs. LLC subsidiaries of Bayer Corp. (now Bayer Schering Pharma) Hollister-Stier became an independent company through a management buyout in 1999, and was acquired by Jubilant Organosys (India) in April 2007.
Manufacture: The bacteria are independently cultured in beef brain and heart infusion media. Harvested bacteria are inactivated with phenol, pooled, and formulated.
FDA class: Biologic PLA
CBER class: Bacterial Antigens and Vaccines
Approvals: Date = 19140803; first approval; granted to Cutter Labs. (Miles/Bayer); according to the CBER/FDA database
Date = 19420000; first approval; according to an older CBER approvals listing
Date = 19760427; first approval; according to a 1979 Office of Technology Assessment (OTA) approvals list (wrong)
Date = 20000803; license voluntarily revoked
Status: The product is no longer approved, manufactured, or marketed. License revocation was announced in the Federal Register:, May 29, 2001, vol. 66, no. 103, p. 29148-9. FDA considered this product unsafe, because there were no standards or assays to assure consistency. See 21 CFR Sec. 610.19; Federal Register, Jan. 5, 1979, vol. 44, p. 1544-9; and Federal Register, Nov. 8, 1977, vol. 42, p. 58266-318.
Medical: This vaccine was used for treatment of bacterial respiratory infections, primarily before the availability of antibiotics. Adults and children received 0.5 mL by subcutaneous injection on day one; 0.05 to 0.1 mL repeated 4-7 days apart; with a maintenance dose of 0.5-1.0 mL every 1-2 weeks. Patients exhibiting hypersensitivity required dosage delay and/or adjustment. For treatment of more acute disease, the initial dose was 0.2 mL, followed by increasing increments of 0.02-0.05 mL every 3-5 days.
Companies involvement:
Full monograph
406 Bacterial Antigens/Mixed
Nomenclature:
Bacterial Antigens/Mixed [BIO]
MRV Mixed [TR]
Polyvalent Bacterial Antigens with "No U.S. Standard of Potency" [FDA]
Mixed Respiratory Vaccine [SY]
NDC 00118-9012-00 [NUM NDC]
FDA Class: Biologic PLA
Year of approval (FDA) = 1914
Date of 1st FDA approval = 19140803
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
bovine materials used<!-- bovinesource -->
ovine (sheep) source materials
vaccines, bacterial
vaccines, subunit
agar
bacterial culture <!-- bacterialculture -->
blood infusion media, ovine
bovine brain infusion media
bovine heart
bovine heart infusion media
brains, bovine media
Branhamella catarrhalis
Diplococcus pneumoniae
Klebsiella pneumoniae
Moraxella catarrhalis
Neisseria catarrhalis
ovine blood infusion media
peptone (medium)
Staphyloococcus aureus
Streptocccus pneumoniae
Streptococcus viridans
yeast extract
phenol
sodium chloride
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
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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