Masterstudiengang "Drug Regulatory Affairs"


Adjuvants in Human Vaccines ***

Dr. Carolina Cassara (Abschlußjahr: 2011)

“Immunization is one of the most powerful and cost effective of all health interventions”(State of the world´s vaccine and immunization, WHO, 2009). Despite significant effort, infectious diseases continue to be the main cause of death. Diseases like malaria, dengue and other re-emerging threats have increased. Additionally, new strategies need to be reviewed to prolong vaccine supply in case of pandemic, natural disasters and bioterrorism situations. Furthermore, improved and new vaccines are needed for special populations (pediatric, elderly or immunosuppressed). Under this context, adjuvants are playing a major role to reach the above objectives. Effective adjuvant systems are crucial for manufacturing vaccines in a shorter period of time and in higher quantities. Alternatively, adjuvants can increase and direct the immune response, lengthen effectiveness and trigger a different set of protective response beyond the traditional antigen/antibody approach.

The current regulations identify adjuvants as component of the vaccine formulation. Thus, each individual adjuvant/antigen formulation will be licensed. Guidance documents identifying the distinctive features of adjuvant are actually scarce.

The selection of the adjuvant depends on the disease pathogenesis, antigens involved, target population, and understanding of the mechanism of action of the adjuvant. The challenge is to address the gaps in our knowledge to define the criteria for acceptability and define the pathway to licensure. For more than 70 years aluminium salt was the only vaccine adjuvant licensed for clinical use, showing the hurdles of licensing a vaccine containing a novel adjuvant.

This work attempted to underline the regulatory challenges of licensing an adjuvanted vaccine formulation for human use within the actual scientific framework.

Furthermore, it describes the actual regulatory approaches and global efforts to keep pace on this field, leaving open questions in some of the gaps that need to be faced.

Pages: 57