Adjuvants: present regulatory challenges.
Research on new adjuvants and delivery systems has expanded dramatically in the last decade. New generation vaccines, based on recombinant proteins, synthetics, and conjugated antigens have emerged but they have limitations because of their poor immunogenic properties, and therefore more cooperative adjuvants for the promotion of the immune response are required. Different molecules have been screened for their ability to enhance the immune response to vaccine antigens, e.g. liposomes, protein cochleate formulations, ISCOMs and cytokines, to name the few. However, most of the vaccines that are currently licensed use aluminum salts or calcium phosphate.
Pascual
Danay Mora
DM
Biological Department, State Control Center for the Quality of Drugs (CECMED), 200 Street No. 1706, P.O. Box 16065, CP 11600 Havana, Cuba. danay@cecmed.sld.cu
Morales
Rolando Dominguez
RD
Gil
Erich Duque
ED
Muñoz
Lázara Martínez
LM
López
Juliette Escoto
JE
Casanueva
Olga L Jacobo
OL
D000276:Adjuvants, Immunologic / Q000009:adverse effects* / Q000494:pharmacology*; D017277:Drug Approval; D016503:Drug Delivery Systems / Q000009:adverse effects; D004335:Drug and Narcotic Control; D017408:Guidelines as Topic
D000276:Adjuvants, Immunologic