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Attenuated parasite vaccine: When and How?

Source: TropIKA

Title of the session: Attenuated parasite vaccine: When and How?

Date: 3rd November 2009

Agenda item: Controversy 2

Session theme:

Meeting room: Amphitheatre

Chair(s): Patrick Duffy/Seattle

Presenters:

• Stephen Hoffman/Sanaria Inc, Rockville
• Egeruan Babatunde Imoukhuede/ European vaccine initiative, Heidelberg, Germany

Official rapporteur:

TropIKA rapporteur: Onikepe Folarin

Major topics:

Keywords:

• Vaccine
• attenuated
• safety
• efficacy
• clinical development plan

Scope: The session is a controversy on whether malaria vaccine should be or not particularly in Africa where the scourge of malaria is very high

REPORT ON ORIGINAL SESSION

Overview

The controversy concentrates more on whether there is the need for malaria vaccine particularly in Africa or not. Babatunde Imoukhuede gave an overview of characteristics of a good vaccine which include safety and effectiveness in terms of immunogenicity. However, the efforts required to produce, maintain and deploy are too enormous for the African community. Issues such as cost, administration, accessibility, lack of data on stability in terms of storage in countries where there is limited power supply and the enormous cost of purchasing liquid nitrogen were some points raised against malaria vaccine development. Other points of argument were the ethical issues and lack of pre-clinical studies to confirm route of administration. Overall, according to Babatunde Imoukhuede, malaria vaccine production is not cost effective and ultimately will be too expensive for resource poor countries and indirectly mean that malaria vaccine is produced for the US military and not for widespread use.

Stephen Hoffman of Sanaria Inc in his argument for malaria vaccine agreed that the hurdles and price for the production of malaria vaccine are enormous. He was, however, optimistic that it is possible and can be done from his group experience. For malaria vaccines, the first goal is to produce a safe and highly effective vaccine that prevents malaria and if successful the next is producing adequate quantities and delivering to population with highest requirement at a reasonable cost. He recognizes the fact that a single vaccine candidate may not be very effective and that means a need for hybrid malaria vaccine but he concludes that if a very good malaria vaccine is produced for the developing world then it can generate funds for the developing world.

In the argument against malaria vaccine, it is obvious that there are no clinical development plans which include route of administration, feasibility and unguaranteed batch consistency among others for population at risk. Lack of data on stability and the astronomically high cost of production will also make availability too costly for the populations that require the vaccines most. Stephen Hoffman also agreed to the fact that the challenges are enormous but the fact that other vaccine production and implementation were successful makes malaria vaccine also possible.

From formal presentations

Public health Implications

If a safe and effective vaccine is produced and clinical trials successfully carried out, then millions of life will be saved and there will be an overall reduction in the malaria burden.

From open discussions/debates

The issues raised were how to overcome the challenges of vaccine development, implementation and good clinical development plan. Other questions were how malaria vaccine will be manufactured such that it will be pure by avoiding contamination and how safety will be assessed. The final question was when it is likely to have first malaria vaccine in the market

Identified conclusions

Main points of agreement

Malaria vaccine production is very costly and might not be feasible.

Main points of divergence

The feasibility of malaria vaccine considering all the challenges

Comments

Stephen Hoffman, who is favorable disposed to development of malaria vaccine, noted that single vaccine candidate will not be effective considering the parasite biology but a combination of vaccine candidates into one will give the best result

Comments