Rubella and Mumps Virus Vaccine Live - BIAVAX II
Status: withdrawn from the U.S. market
Organizations involved:
Merck & Co., Inc. – Manuf.; R&D; Tech.; world mark.
Cross ref: See the entries for component vaccines – Rubella Vaccine Live (Meruvax II) (#533) and Mumps V irus Vaccine Live (Mumpsvax) (#504). See the Measles, Mumps and Rubella Virus Vaccine Live (M-M-R II) entry (#493).
Description: Rubella and Mumps Virus Vaccine Live or Biavax II is a lyophilized (freeze-dried) formulation combining Rubella Vaccine Live (Meruvax II) and Mumps Virus Vaccine Live (Mumpsvax). The vaccines are mixed in final liquid bulk form before lyophilization.
After the vaccine is reconstituted, each 0.5 mL dose contains >1,000 TCID50 of the U.S. Reference Rubella Virus (maintained by CBER, FDA) and 20,000 TCID50 of the U.S. Reference Mumps Virus, along with about 25 µg of neomycin, and sorbitol and hydrolyzed gelatin (bovine) as stabilizers. The product contains no preservatives.
Nomenclature: Rubella & Mumps Virus Vaccine [BIO]; BIAVAX [TR]; Rubella and Mumps Virus Vaccine Live [FDA]; Rubella and Mumps Virus Vaccine, Live [FDA former]; NDC 0006-4746-00; NDC 0006-4669-00 [NDC]
Companies.: Biavax II was developed and manufactured by Merck & Co., Inc. (West Point, PA), CBER/FDA lic. no. 0002. It was marketed in the U.S. by Merck & Co., Inc., and internationally by Merck & Co. affiliates. It is apparently no longer manufactured.
FDA class: Biologic PLA
CBER class: Viral And Rickettsial Vaccines
Approvals: Date = 19700803; first approval, PLA
Date = 19860106; product license revoked under old proper name and granted (reissued) under current FDA proper name
Indications: prophylaxis against disease due to rubella virus infection and mumps virus infection [unofficial]
Status: FDA approval was voluntarily revoked in recent years. With rubella vaccination now using M-M-R II or new ProQuad, there likely was negligible need or demand for Biavax. Market: Average Wholesale Price (AWP) not available (not in 2005 or 2004 Red Book).
Competition: This bivalent vaccine has no competition in the U.S. market. However, most measles vaccinations in the U.S. involves use of the triple combination Measles, Mumps and Rubella Virus Vaccine Live (M-M-R II) or a newer quadruple combination vaccine, ProQuad.
Companies involvement:
Full monograph
534 Rubella & Mumps Virus Vaccine
Nomenclature:
Rubella & Mumps Virus Vaccine [BIO]
BIAVAX [TR]
Rubella and Mumps Virus Vaccine Live [FDA]
Rubella and Mumps Virus Vaccine, Live [FDA former ]
NDC 0006-4746-00; NDC 0006-4669-00 [NUM NDC]
FDA Class: Biologic PLA
Year of approval (FDA) = 1970
Date of 1st FDA approval = 19700830
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
bovine materials used<!-- bovinesource -->
chicken source materials
human materials used<!-- humansource -->
live microorganisms (as active agent)
vaccines, combination
vaccines, live
vaccines, viral
cells, human
chicken embryo (egg) culture
Jeryl Lynn strain, mumps virus
mammalian cell culture
mumps virus Jeryl Lynn strain
RA 27/3 Wistar Inst. strain, rubella virus
rubella virus Wistar Inst. RA 27/3 strain
virus culture
Albumin (Human)
bovine serum, fetal (FBS)
gelatin (bovine source)
lyophilized (freeze-dried)
neomycin
sodium chloride
sodium phosphate
sorbitol
sucrose
U.S. Reference Mumps Virus
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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