Stakeholder Opinions: Vaccine Adjuvants - Uncertainties Rule

By Author: Bharat Book Bureau
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Adjuvants are coming increasingly into focus for vaccine developers since many novel split- and subunit vaccines are insufficiently immunogenic on their own. Adjuvants offer a solution: they can accelerate, enhance and prolong the immune response to vaccination but also enable the use of antigen-sparing formulations. This makes them an attractive option for prophylactic and therapeutic vaccines.

Scope of this report

In-depth analysis of key TLR-dependent and TLR-independent adjuvant candidates in clinical development

Thorough assessment of key opportunities and risks for novel adjuvants

Review of clinical trials and available data for adjuvants in development

In-depth discussion of regulatory hurdles and strategic advice on how to overcome them

Research and analysis highlights

In order to overcome the high regulatory barriers, adjuvant developers should focus on indications with high unmet need and no available vaccines. As safety and reactogenicity will be key factors in the FDA's evaluation of novel adjuvants, the barrier to approval of novel adjuvants is lower for therapeutic ...
... than for prophylactic indications.

It sees combinations of immunostimulatory adjuvants with efficacious delivery systems as a promising approach, but hurdles to approval for these combinations will be higher than for single-component adjuvants. The future regulatory performance of GSK's AS04 will have a crucial impact on the prospects of such combination approaches.

Most available licensed adjuvants, such as alum and MF59, stimulate a strong Th2 response, making them unsuitable for a large number of indications requiring a CTL-mediated immune responses. Novel adjuvants could significantly improve the prospects of vaccine development in indications with a high unmet need, including cancer and tuberculosis.

Key reasons to read this report

Review profiles and clinical data of key adjuvants both marketed and in clinical development and assess their future potential

Gain insight into the current state of the vaccine adjuvant industry and its future chances and challenges

Understand regulatory hurdles and develop strategies to maximize chances of approval for novel adjuvants

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