Progress in the battle against malaria has been achieved through large-scale deployment of insecticides and effective drugs in the last decade. However, successful implementation of these interventions is highly resource –intensive and acutely dependent on strong public health systems, continued donor support and sustained collaboration across sectors.
There are no vaccines against malaria on the market, and they are increasingly needed because of :
a) the size of the health problem;b) the soon coming lack of effective treatment;c) the superiority of prevention over cure;d) vaccines have by far the best cost-effectiveness ratio both in financial as in Public Health terms.
1. Very low safety risk with 2nd-Generation MSP3 Bio-fusion
As it combines 2 very-well tolerated molecules: the first generation MSP3-LSP with safety records in 6 clinical trials (4 of them in young African children) and CRM 197 with safety records in hundred millions of individuals.
2. Very high chances of efficacy
In the children vaccinated by MSP3, higher anti-MSP3 antibodies are associated with higher protection, and the second generation Bio-fusion induces a major increase in the same antibodies.
3. Unusually short time to Proof-of-concept, as Key milestones are
- At one year: expected Immunogenicity reached and Safety
- At 2 years: Improved Clinical Efficacy in field trials (MSP3-Biofusion); or in malaria infected mosquitoes challenge trials (LSA3-Biofusion)
4. Due Diligence already performed by Sanofi & precise Roadmap of development defined
Why Invest in Vaccines against Malaria
- Safe malaria vaccines that are highly protective and easy to deploy would greatly complement current prevention and treatment measures. Malaria vaccines would safeguard against widespread drug and insecticide resistance that could erase all the gains achieved in the last decade. Vaccines have the record of being a cost-effective medical tool against serious infectious diseases and in the case of smallpox, polio and measles, an indispensable tool of elimination.
- There are no malaria vaccine on the market, and limitations of the first-generation malaria vaccines, such as GSK RTS,S, underscore the need for better second generation vaccines.
- Over the last decade, there have been efforts to address health inequities, which have increased access to life-saving vaccines and this has changed the landscape for the public health. For vaccines, the most influential effort is the Global Alliance for Vaccines and Immunizations (GAVI). GAVI spends up to US$1.3-1.5 Billion annually on vaccine purchase for eligible countries and recently has prioritized malaria vaccines as a future purchase.
- Donors are also looking to create additional incentives for industry such as malaria vaccines pre-market commitments where donor subsidies for the future successful vaccine act as a guarantee of a viable market, something already in place for second-generation pneumococcal vaccines. This, along with the emergence of new and alternative markets and pharmaceutical industries, all represent both demand-stimulating mechanisms and potential market opportunities for vaccines against malaria.
There are two main and very distinct markets :
1. The market of endemic area populations or the Southern Market
The endemic area market is very wide as 3.5 Billion live in regions where they are exposed to malaria. It is influenced by several parameters, the main being the vaccine profile :
- For this market, a relatively costly vaccine (30 USD) with side effects, such as GSK-Gates RTSS, would be administered only to the most exposed;
- A low cost (1 USD), well-tolerated vaccine which corresponds to MSP3-Biofusion target profile, would be administered to all “exposed“ population, starting with intertropical Africa, extending later to the African continent, plus the many endemic areas in Asia & South America.
Other factors modulating the shape of the southern market are :
- The population growth is exploding and the size of the population requiring most to be protected against malaria is dramatically increasing. Today the majority of cases and fatalities prevail in Africa, a region where mothers have an average 8 children, where health care has progressed, and where the current estimated one billion inhabitants is expected to double to reach about two billion within the next 10 years.
- The groups at risk in Africa were, until recently, children under 5 and pregnant women but today as a result of control measures, the group at risk extends to older children and adolescents, multiplying by about 5-fold those in need of protection.
- The malaria-drugs pipeline has not been supplying the drug(s) which could take over, once artemisinin resistance has spread. This also stresses the need to prepare for a likely severe lack of treatments.
- Vaccines have a superior track record as a control tool, and with a richer pipeline than drugs, can be developed faster than new drugs which are yet to be identified.
2. The Travelers Market - Northern Market
The travelers (army, tourists, business travelers) market is the best defined: there are about 40 million annually who travel from EU-US to malaria endemic areas. More travel for leisure, commerce and family reasons occur to and from developing countries than ever before. Traveling and migration patterns and behavior have evolved dramatically over the last fifty years, with the democratization of air travel and the globalization of industrial activities.
With increase in travel to these areas, it is projected that this will increase to 60 million projected in 2020. Many travelers fail to protect themselves efficiently while traveling to areas of high incidence, as necessary measures are cumbersome, expensive and do not provide complete protection. Considering the variation in traveler behavior, attitudes towards travel and duration of stay, it was conservatively estimated that the market demand from travelers would be approximately 3.8 million people per year in 2025.
Recent studies in Europe (Switzerland and United Kingdom) and the US have estimated the cost of malaria prophylaxis to be around 44 USD to 300 USD per week or visit, varying depending on the drug regimen, duration of travel and health insurance reimbursement. Considering that efficacy is dependent on compliance to a daily regimen that many find challenging, a vaccine would be easily a more welcome and popular alternative.
Personnel, both military and non-military deployed to endemic areas are expected to take malaria prophylactic drugs as instructed and to use personal protective measures such as mosquito nets and insecticide-impregnated uniforms.
Compliance with chemoprophylaxis is poor and the rapid emergence of malaria drug resistance and the dwindling number of options for chemoprophylaxis make this a risky strategy to rely on. Personal protective measures are not 100 percent effective on their own, and insecticide resistance is an additional threat to the continued effectiveness of impregnated materials. Both chemoprophylaxis and mosquito net availability depend on supply chains that may not be fully operative in combat and emergency deployment situations, presenting another situation of potential demand for a malaria vaccine.
Why Invest in Vac4All
- Although numerous initiatives support malaria vaccine development, the call for malaria elimination and eradication has caused some major funders to focus on only vaccines that target transmission interruption and to disavow the development of blood-stage vaccines like MSP3 and question the value of mimicking natural immunity as a vaccinology strategy. This leaves a real and unfortunate gap in the development for vaccines that address the most urgent and pressing medical need, vaccines that directly reduce diseases and infections. Vac4All’s portfolio specifically targets this gap.
- We strongly believe that with a puzzle as complex and persistent as malaria, to shut the doors of opportunity presented by existing human models of immunity is premature, especially when mimicking human immunity represents the foundation of much of successful vaccinology today. The reality is that highly effective vaccines against disease and infection will also have an effect on disease transmission and could contribute to its elimination. No other malaria vaccine developers are fully exploiting clinical malaria immunity models, giving our company a major competitive advantage, as this has been the foundation on which our vaccines emerge.
- Over the years, in-house analytical knowledge and tools have been developed, including more relevant screening strategies such as the HIMM which has also allowed investigation of T-regulatory regions, an approach which could lead not only to reproducing natural immunity but improving it. Finally the use of the carrier protein is a unique approach to increase the magnitude and durability of vaccine responses needed for ultimate success.