Control and lot release of meningococcal group C conjugate vaccines.
Meningococcal group C conjugate vaccines were first introduced to the UK in 1999. To date, the vaccines have been demonstrated to have an efficacy of approximately 90% and have since been adopted by other countries worldwide. The development of control tests used for lot release of meningococcal group C vaccines has been based on those used for Haemophilus influenzae type b conjugates, the key criteria being measurement of free saccharide and conjugate integrity by physicochemical means. In future, meningococcal group C vaccines are likely to be replaced by multivalent formulations containing different components in combination. This will present a new challenge for regulatory authorities and more extensive testing will be required to ensure vaccine safety and efficacy.
National Institute for Biological Standards and Control, South Mimms Potters Bar, UK. jsuker@nibsc.ac.uk
Janet
J
Suker
Ian M
IM
Feavers
Michael J
MJ
Corbel
Christopher
C
Jones
Barbara
B
Bolgiano
D017607:Aluminum Compounds / Q000737:chemistry; D000818:Animals; D004355:Drug Stability; D006801:Humans; D009682:Magnetic Resonance Spectroscopy; D022401:Meningococcal Vaccines / Q000737:chemistry* / Q000276:immunology; D038542:Neisseria meningitidis, Serogroup C; D011135:Polysaccharides, Bacterial / Q000032:analysis*; D011786:Quality Control; D018074:Vaccines, Conjugate / Q000737:chemistry / Q000276:immunology
D017607:Aluminum Compounds; D022401:Meningococcal Vaccines; D011135:Polysaccharides, Bacterial; D018074:Vaccines, Conjugate; C037676:meningococcal group C polysaccharide; C410218:serogroup C meningococcal conjugate vaccine