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09 December 2016
Alfred Romann / BioWorld
DOHA, Qatar – Tuberculosis, malaria, pandemic flu and an unknown disease are among the scariest infectious disease threats according to a group of experts gathered in Qatar for a global health summit. And, on a scale of one to 10, the state of readiness of the world to deal with such an outbreak was a resounding three.
One key area of concern for these experts gathered at the World Innovation Summit for Health (WISH) in Qatar recently is the global ability to effectively develop, manufacture and distribute vaccines in both developed and developing countries. At the heart of this generally poor preparedness is a lack of a global infrastructure for research and distribution into new and innovative medical technologies, including drugs and vaccines.
"Vaccines are the most cost-effective interventions in health care," said Seth Berkley, CEO of Switzerland-based vaccine alliance GAVI, but "vaccines don't deliver themselves."
"What we need to have is a system to be able to get vaccines out, new ones . . . but also to make sure those vaccines have a market. They will be purchased; they will be stockpiled," he said.
And for this, a multilateral or global effort is needed because a lot of the developing countries that need the vaccines the most don't have the drawing power or financial resources that will create the type of innovation that is needed.
An example of how this could play out is with the new malaria vaccine RTS,S (also known as Mosquirix) developed by Glaxosmithkline plc. RTS,S addresses only one strain of malaria and requires four doses, three of which are outside of the GAVI system. Still, in phase III trials, the vaccine demonstrated 39 percent efficacy against clinical malaria so it could emerge as a powerful tool.
Another example of innovation in the deployment of innovative treatments is a new Gavi experiment to use drones in Rwanda to deliver vaccines. And yet, despite the many options and innovative vaccines available and in development, there are chronic concerns around distribution. A case in point is the lack of preparedness related to influenza.
A serious pandemic could prove devastating and is almost certain to happen at some point. During the 2009 outbreak of pandemic flu, for example, there were simply no vaccines to get to developing markets, said Berkley. The world dodged a bullet with a relatively mild strain of flu, but the reality is the outbreak highlighted the stark fact that global capacity to deal with an infectious disease outbreak is surprisingly weak. This is despite the fact that the existing market for a flu vaccine is a good one.
"Influenza is a profitable market . . . but to prepare for a pandemic situation we really need to transition from an old-fashioned manufacturing situation," said John Arne Røttingen, interim chief executive director of the Coalition for Epidemic Preparedness Innovation (CEPI). This reality became painfully evident during the Ebola outbreak in West Africa in 2015. But the outbreak also demonstrated that the technology to address these shortages in vaccine production is available.
"We had no Ebola vaccines tested on humans, at least among the promising candidates, at the time of the Ebola outbreak," said Røttingen. "And within less than a year we managed to conduct more than 50 clinical trials both in Europe and North America and most importantly in the affected countries."
THE REAL PROBLEM: DEPLOYMENT
The challenge, then, appears to be not in the availability of technology but on how it is deployed.
All these challenges play out in countries like Vietnam, a rapidly growing economy in Southeast Asia that has to deal with both emerging and well-established infectious diseases, from Zika to Middle Eastern Respiratory Syndrome (MERS) along with malaria, dengue and more, said Vietnam's Minister of Health Nguyen Ti Kim Thien.
"We should produce [vaccines) by ourselves," said Nguyen, but pointed out that Vietnam needs international support to produce vaccines or buy them. As Vietnam has grown richer, global support has faded. The problem is that the country is nowhere near rich enough yet to stand on its own, nor can it support domestic vaccine manufacturers.
The private sector and the market can play key roles in driving innovation and the deployment and distribution of innovative products.
"Because of the close collaboration [between the] public and the private sector, the national regulatory authorities, ethics review boards and everything . . . we demonstrated quite solidly so that there can be an effective vaccine and we demonstrated that in Guinea," said Røttingen. "And that leads back to the global architecture."
"We need a division of labor. We need a marketplace for [vaccines]," said Røttingen. "It doesn't make sense that each country goes it alone instead of doing it collectively."
"The technology is fine, but we have to use the technology," said George Alleyne, director emeritus at the Pan-American Health Organization (PAHO). Polio, for example, was eradicated in the Americas because the infrastructure was there to deliver a vaccine, said Alleyne.
The market and the cost of manufacturing vaccines are important considerations.
"You can't have vaccine producers in every country. The plants are hugely expensive. The quality of vaccines and the complexity of them are getting much harder," said Berkley. "So the challenge, again, is having a global scheme that says not one manufacturer for every vaccine but not 100. The most cost-effective point is going to have to be a marketplace with five to seven manufacturers."
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