The pharmaceutical industry often comes under heavy criticism for creating medicines for western or mature markets “where the money lies”. In recent times it has come in for even harsher, yet misplaced, criticism for “cashing in” on the rare disease sector, despite the fact that therapies for this area are desperately needed and complex to develop.
Some 30 years in the making, GSK’s malaria candidate vaccine, Mosquirix, however, is testimony to the fact that the industry takes seriously its obligation to the developing world and is committed to finding new therapies and preventatives to tackle infectious diseases across the globe.
Mosquirix has just been given the thumbs up by the European Medicines Agency and represents a break-through on several levels. In fact, it is impossible to overstate the value of this preventative jab. In simple terms, it is the first vaccine to target malaria – a noteworthy coup in its own right. The reality, though, is that Mosquirix is even more prodigious: while we already have vaccines against bacteria and viruses, this it is the first vaccine ever to take aim at a parasitic disease.
The fact that some 3.2 billion people – almost half the world’s population – are at risk of contracting malaria, and there are about 200 million cases each year, puts the true value of this vaccine into perspective.
GSK’s Mosquirix offers a pre-emptive strike against the plasmodium falciparum parasite, the most prevalent malaria parasite in sub-Saharan Africa, which was responsible for a significant portion of the estimated 584,000 malaria-related deaths in this geographical area in 2013. Moreover, it is because the plasmodium falciparum parasite is capable of adapting to the human host and escaping its immune responses, that the development of this vaccine has been both a serious challenge and a resounding success.
While it is not 100% effective, it is an enormous step in the right direction and forms part of the armoury – including, for example, bed nets, insecticides and rapid diagnostics tests – that we now have in place against one of the developing world’s most devastating diseases. What’s more, clinical trials have shown that the vaccine has an acceptable safety profile for use in humans. This offers vital reassurance to all parties involved in its development and eventual distribution, given that a large proportion of those receiving the jab will be babies and young children.
The next step is to secure early access to the drug, but this is no simple matter. First, the World Health Organization has to make a policy recommendation for the vaccine candidate and this may be possible by the end of 2015. GSK will then need to apply for a WHO ‘pre-qualification’, following this up with applications for marketing authorisations in sub-Saharan African countries.
Partnership has been central to the development of Mosquirix. Phase 2 and 3 trials in Africa were run with the PATH Malaria Vaccine Initiative – an NGO that had financial support from the Bill & Melinda Gates Foundation – in addition to prominent African research centres and their Northern research partners.
Against this backdrop, it is interesting to note that Sanofi has taken a different route to developing another vaccine, this time aimed at combatting another mosquito-borne disease. The French manufacturer is on target to create a vaccine against dengue – in itself an astounding breakthrough – but has self-financed the entire process, thereby taking the entire risk on its own shoulders.
Sanofi has also embarked upon a different authorisation route, registering directly in countries in which dengue is prevalent and applying for WHO pre-qualification, essentially the stamp of approval of the international community.
Both GSK and Sanofi have showcased the commitment of the pharmaceutical industry to the long-term future of the developing world. The will is clearly there. Production capacity, though – and the incredible, additional investment this requires – might prove to be the main hurdle to achieving widespread supply quickly.