title: Standardization may suffice for licensure of conjugate vaccines.
abstract: Standardization schemes devised by Control Agencies have followed clinical trials of experimental vaccines. The wealth of information about the pathogenesis of and immunity to bacteria, whose surface polysaccharides are protective antigens, now permits standardization to predict the efficacy of polysaccharide-based vaccines. There has been tacit acceptance of this notion with the licensure of groups Y and W135 meningococcal vaccines and of many of the pneumococcal types whose frequency in patients was too low for statistical significance to be assigned for their clinical efficacy. In fact, this was also the case for licensure of polio virus type 2 vaccine. We can reliably measure the level of anti-polysaccharide antibodies for meningococci, pneumococci, GBS and the Vi of S. typhi. Haemophilus type b conjugates have been reliably standardized by physico-chemical assays. New conjugates, therefore, may be licensed by data provided by standardization without awaiting the results of costly and time-consuming efficacy trials. Adoption of this scientifically-based approach to licensure will hasten the implementation of new and more effective vaccines.
authors.affiliation: National Institute of Child Health and Human Development, NIH, Bethesda, MD 20892, USA.
authors.forename: J B
authors.initials: JB
authors.lastname: Robbins
authors.forename: R
authors.initials: R
authors.lastname: Schneerson
authors.forename: S C
authors.initials: SC
authors.lastname: Szu
authors.forename: D A
authors.initials: DA
authors.lastname: Bryla
authors.forename: F Y
authors.initials: FY
authors.lastname: Lin
authors.forename: E C
authors.initials: EC
authors.lastname: Gotschlich
mesh_terms: D001428:Bacterial Vaccines / Q000276:immunology / Q000592:standards; D002648:Child; D022121:Cholera Vaccines / Q000276:immunology / Q000592:standards; D004335:Drug and Narcotic Control; D018073:Haemophilus Vaccines / Q000276:immunology / Q000592:standards; D006801:Humans; D009345:Neisseria meningitidis / Q000276:immunology; D022242:Pneumococcal Vaccines; D011135:Polysaccharides, Bacterial / Q000276:immunology; D012015:Reference Standards; D013292:Streptococcus agalactiae / Q000276:immunology; D013296:Streptococcus pneumoniae / Q000276:immunology; D014436:Typhoid-Paratyphoid Vaccines / Q000276:immunology / Q000592:standards; D018074:Vaccines, Conjugate / Q000276:immunology / Q000592:standards*
chemical_list: D001428:Bacterial Vaccines; D022121:Cholera Vaccines; D018073:Haemophilus Vaccines; D022242:Pneumococcal Vaccines; D011135:Polysaccharides, Bacterial; D014436:Typhoid-Paratyphoid Vaccines; D018074:Vaccines, Conjugate