RotaFlash, August 2014
Rotavirus vaccines have been introduced in Niger and Eritrea, bringing the global...
Insufficient supply and high prices are major factors that can delay the availability of lifesaving vaccines in low-income countries—sometimes for decades following their adoption by wealthy countries. Shortening these timelines and improving accessibility for populations that natural market forces often leave behind takes a collective effort from an intricate web of partners along the vaccine development continuum. Luckily, we know someone who is an expert at building partnerships.
Meet Linda Nyari, director of the commercialization and corporate partnerships team for PATH’s vaccine development program, which advances the development of new, affordable vaccines for low-resource countries. Her team of business and legal professionals is responsible for shaping the strategic partnerships that steer a new vaccine’s journey from the laboratory to saving the life of a child in need. We sat down with her to get a behind-the-scenes look at what it takes to set these partnerships up for success.
How does your team help make vaccines accessible for underserved populations?
As a nonprofit organization, PATH doesn’t have its own vaccine development laboratories. So for us to accelerate access to new vaccines for our target populations, we have to collaborate with various partners that can develop, manufacture, and distribute the vaccines appropriately. These partners include nonprofit organizations like universities and research institutions, and commercial partners like vaccine manufacturers, biotechnology, and multinational pharmaceutical companies. My team negotiates the agreements to work with these partners—the legal written word that describes how the parties are going to work together. We put provisions in place (such as appropriate license rights or price structures) that keep doors open for the vaccine to become available for underserved populations, while also building in protections to help our partners be successful.
What does success look like?
The objective of our work is to enable a vaccine to be commercially sold at a price that is affordable and sustainable for low-resource countries and to ensure an appropriate supply of the vaccine so that it can be introduced into those countries. Since our work is integral to the partnerships required to achieve these objectives, we engage throughout the entire vaccine development process from preclinical research through to product registration. Critical to success is ensuring the sharing of data, which can help advance a specific vaccine or the larger vaccine development field. A catch phrase that is often used for what we’re trying to accomplish through this body of work is ‘global access.’
What is in it for the partners?
Due to perceived difficulties in achieving a return on investment, vaccine developers with good ideas are often reluctant to pursue a vaccine primarily needed in low-resource countries if the countries could have difficulty paying for it. Others may simply need assistance to develop the vaccine or to enter developing-world markets. Our program incentivizes companies to pursue such vaccines by providing donor funds to support the work and technical expertise to help successfully move the development forward.
To take a product forward and actually sell it, you need a champion, and usually that’s a for-profit company (either in the developed or developing world). So, we’re saying to such partners that they can move forward with whatever business strategy they want in the developed world, as long as the technology is made affordable and accessible for public-sector markets in low-resource countries. Overall, we try to make it a win-win for both sides. If it’s too skewed, you can’t have a successful relationship.
Are there any success stories that you can share?
In the fight against deadly childhood diarrhea, solid relationships with strong partners have helped us near the point of seeing more than one new rotavirus vaccine being successfully developed. We’re also advancing vaccine development against the leading causes of bacterial diarrhea—enterotoxigenic Escherichia coli and Shigella—for which no vaccine currently exists. In this case, the developed-world market for such vaccines is not big enough to attract large pharmaceutical companies, but vaccines against these pathogens are greatly needed in the developing world. So through our partnerships with smaller biotech companies and research institutions, we’ve seen a broadening of awareness and the value put on such vaccines, which will hopefully lead to a positive vaccine development success story.
What do you find inspires you about your work?
A positive for me is marrying science, law, and business. Providing the business and legal expertise in support of finding a vaccine that is beneficial for children in low-resource countries makes for what I’ve always considered to be both meaningful and interesting work, particularly because the outcome is not how much profit can be achieved, but rather how society can benefit. It’s how quickly we can facilitate the development of a safe and efficacious vaccine that we can introduce where it’s most needed. I am proud to be a part of that effort.
Photo credit: PATHRead more
The mothers’ group in Chorm Trach meets to discuss preventing and treating diarrhea. Photo: PATH/Anne Aumell.
PATH’s Anne Aumell, a member of our Development team, traveled recently in Southeast Asia, where she saw some of the innovative work our generous donors have made possible. Here’s her report from Cambodia on our efforts to help mothers protect their children from potentially deadly diarrhea.
When I plan a trip, I think a lot about my shoes. They need to be solid for city sidewalks, sturdy for muddy and dusty roads, and fashionable in case I decide to wear a dress. And I must have red Mary Jane’s whenever possible.
Last week, when I was in Siem Reap, Cambodia, a man offered to clean my shoes. They needed it, but I declined. I wanted the dust and mud to be with me a little bit longer. I wanted this evidence of meeting the people of Xem in Vietnam and Kampong Thom province in Cambodia to remain.
A few days earlier, I stepped out of a PATH truck in the Cambodian village of Chorm Trach. I was there to attend a mothers’ group, a quarterly meeting led by the village leader, who in this case is also the village health worker. My PATH colleagues, Vichit Ork, Thunvuth Nop, and Mary Prum, stepped easily into the wooden building with the corrugated metal roof and took seats on the opposite side of the room. I hesitated because, frankly, I was overcome with emotion: I was actually attending a mothers group in Cambodia.
A year ago, two PATH donors said yes to my request that they fund our diarrheal disease program in Cambodia. One, Susanna Cunningham, is on the nursing faculty at the University of Washington and has traveled to Cambodia to train nursing students. The other, Laurie Michaels of Open Road Alliance, funds high-potential projects that need fast, flexible funding. I had never been to Cambodia, but when the two of them decided to support our work, I imagined the mothers who would learn to recognize diarrheal disease in their children, obtain treatment for it, and even prevent it. Now here I was, sitting among them.
The meeting began with a presentation on how to get oral rehydration solution and zinc treatments and continued with information about acquiring latrines. The quarterly mothers’ group meeting presents information like this as part of PATH’s work to prevent diarrhea in the community.
Hem Taing Oy’s latrine. Photo: PATH/Anne Aumell.
After the meeting, Hem Taing Oy showed us her latrine, purchased for $450 by her son, a construction worker, and her daughter, a house maid. Both work in Phnom Penh. When they return home, they want a safe and clean place to “go.” Her latrine is one of only six among 106 households in this village.
As we walked along the road in Chorm Trach, children waved from their yards, and we saw that a new wing for the school is being built. In a couple of years, there will be more latrines, more water filters, and fewer cases of diarrheal disease. As I said in my earlier post from Vietnam, PATH’s in this for the long haul. Our donors are too.
For more information:
-- We're combining forces in Cambodia to overcome diarrhea and pneumonia.
-- Policy change to improve child health in Cambodia.Read more
Hazel loved the taste of her rotavirus vaccine
As a founding member of the Poo Crew, I’ve always been pretty confident that I know my shit. For eight years now, I’ve been helping to craft messages about the threat of diarrheal disease, and I’ve travelled to communities where diarrhea presents a very real danger to children and legitimate fear among their parents.
And then I became a mother – and, well, shit got real. Since my daughter Hazel was born this past July, I have discussed, analyzed, and pondered poop more than ever before… and that was during maternity leave - a million virtual miles from my laptop, logged off defeatDD.org, and on hold from my contributions to PATH’s clinical trials of vaccines against the most deadly diarrhea. Sure, I had written all manner of materials about baby poop, but my own baby taught me that, actually (and in so many more ways than one), I could be pretty clueless. And then, by week 8 or so, I found myself in her pediatrician’s office, internally ashamed, asking, “How do I know if my baby has diarrhea?”
Hazel taking care of "business"
The frequency of her dirty diapers had suddenly increased, and since she’s exclusively breastfed… well, let me put this delicately: there never is any solid to speak of. So how would we know if she entered dangerous territory when a major diarrhea symptom is runniness? That’s a given on a good day! Our daughter was just fine; turns out we’re the ones who were a bit sick with the over-anxiety of new parents. But my mortification at not knowing the real-world answer to such a fundamental question about diarrhea introduced a new realm of respect for other mothers, particularly those in situations where a helpful pediatrician isn’t simply a phone call or quick car ride away.
Where healthcare is scarce, how do mothers know how to recognize danger signs? The parents I visited in rural Zambia last year certainly couldn’t scramble to the clinic every time their babies’ business was questionable. I found myself reflecting on Agnes, and the pivotal, lifesaving role she plays as a community health volunteer for her village. Daily, without fail, Agnes visits the mothers around her to help them recognize the symptoms of diarrhea and the simple steps to prevent it. She also tells them about the new rotavirus vaccine, rolled out in 2012 to protect infants from diarrhea’s most dangerous cause. Without Agnes, the children in her community might very well be in grave danger. She’d say her contributions were training and education. From my new perspective as a mother, I now see that Agnes provides a crucial, compassionate lifeline.
Agnes Mulunga visits a neighbor in Chigwilizano Village to talk about health and hygiene.
While I may have found myself a novice at motherhood, after so many years writing about diarrhea, there was one thing I certainly did know: Hazel was getting her rotavirus vaccine. Protection from the most dangerous cause of diarrhea connected my daughter to babies we saw in Zambia, and me to their mothers. Mothers in the clinics we visited were excited about the new vaccine, and I shared that enthusiasm on our trip back to the pediatrician for Hazel’s first round of immunizations… though my excitement may have been a bit more than our nurse was used to. When I saw that tiny dropper in my own baby’s mouth, I let the full-circle moment sink in. I had learned in ways I never could have imagined how vulnerable my little one could be—and how powerful the vaccines that keep her safe.
I’ve learned how pivotal it is to teach mothers everywhere, in every community, how to recognize when their babies are threatened by diarrhea; how even when I thought I already knew, motherhood had still so much more to teach me. And the real-world gratitude for the vaccine that can protect my daughter from a life-threatening rotavirus infection? Well, let’s just call that lesson “Number Two."
Who knew poo could be so profound?Read more
Dr. Lou Bourgeois, scientific officer for enterotoxigenic Escherichia coli (ETEC) at PATH’s Enteric Vaccine Initiative, recently attended the biennial Vaccines for Enteric Diseases (VED) conference (held November 6-8, 2013 in Bangkok, Thailand). He also served on the scientific advisory panel for the conference, playing a role in reviewing presentation abstracts and shaping the agenda. I recently had a chance to sit down with Lou to hear about some highlights from this year’s conference.
What did you enjoy most about this year’s VED conference?
VED continues to be a fertile ground for sharing new information on vaccines against diarrheal diseases, facilitating synergies, and building partnerships. This year was really energizing because the sheer scope and number of participants was larger than ever. I think the growing interest and participation in VED is wonderful, because it shows just how much increased investment in the field is paying off.
At one time, VED was really only about the great success of rotavirus vaccines, and the other enteric diseases were not represented as much. Just by looking at this year’s agenda, you can see that so many more diseases and types of research are represented. The greater investments from big donors to support enteric vaccine development, such as from the Bill & Melinda Gates Foundation, the UK’s Department for International Development, the European Union, and the Research Council of Norway, along with continuing commitments from the Division of Microbiology and Infectious Diseases at the US National Institutes of Health and the US Department of Defense, are really starting to bear fruit.
In addition, many participants, including the team from PATH, were also involved in targeted side meetings to extend conference interactions with current and prospective vaccine development partners and project donors around specific topics. VED provides such a unique opportunity to bring all of these players together in the same place and have these types of conversations face-to-face. I also enjoyed seeing how much PATH was woven into the fabric of the conference, with so many of our projects on diarrheal diseases represented or involved in a wide range of presentations.
What were some of the most interesting presentations?
Some really exciting developments were presented at VED this year. One is the potential role of a new adjuvant called “dmLT,” which cut across a number of presentations. [Adjuvants are ingredients that may enhance the effectiveness of some vaccines, and “double-mutant heat-labile toxin” or dmLT is an ETEC antigen that may protect against both diarrhea and intestinal infection.] It was encouraging to see that it’s proven to be so safe when given orally, which means that we can now test the dmLT in younger age groups. The actual effect of the dmLT on vaccine effectiveness is still to be determined, but the early results look promising. The stage is also set for testing the parenteral administration [intradermal or intramuscular injection] of dmLT for the first time with a subunit vaccine next year.
Several presentations related to disease burden were also very interesting. A team from the University of Virginia shared their work on new methods for assessing disease burden, results from which solidifies the field’s assumption that many kids actually have two or three pathogens in their stool at the same time. In addition, presentations on recent results from the Global Enterics Multicenter Study (GEMS) and the Interactions of Malnutrition and Enteric Infections: Consequences for Child Health and Development (MAL-ED) project made a strong case for the important pathogens that we really need to focus on. For example, the GEMS data found that Cryptosporidium is among the top causes of diarrhea in young children in Africa and Asia, which is not something that the enteric vaccine field has been focusing on at all. So, I expect that will be a bigger topic at future VED conferences.
The MAL-ED research, which is looking at home visit-based disease burden at the community level, brought up the question of whether or not we are focusing enough on sub-clinical infections [when the pathogen is detected in the stool, but the child is not showing symptoms]. For example, a child can be carrying something like Campylobacter in their gastrointestinal track since early in infancy, which causes an inflamed intestine, without showing any outward signs of disease. So, what is the significance of this, and how might it affect their longer-term health? Although these studies are providing us with lots of new information, there are still a lot of questions to answer!
Were there any negatives?
It was really unfortunate that we weren’t able to have more participation from US military researchers. The US Army and Navy have done a lot for the enteric vaccine field. However, due to increased scrutiny on government spending on conferences, especially in the military arms, it was really tough for many of their leading researchers to get approval to attend VED.
What’s next on the horizon for VED?
Right now, we are working on writing up a summary of the meeting for publication in a scientific journal. Although we have two years until the next VED, because the conference was so successful this year, we are already starting to think about how to continue making it a positive experience for the participants. With VED getting to be so popular, we may have to look at using a new format next time. There are just too many things to cover and so much research going on, that it’s really hard to fit it in to just three days and still allow enough time for discussion. But, we think that this is probably a good problem to have!Read more
As Co-Chair of the All Party Group for Child Health and Vaccine Preventable Diseases, I have been extremely fortunate to visit a number public health programmes in the developing world. With each visit I have been privileged to meet with some of the committed staff that make these programmes possible and have learned more about how sustainable aid programmes can be delivered on the ground.
In recent years I’ve been to Kenya, Bangladesh and Tanzania to see how UK money is being spent on vaccinating children against pneumonia and diarrhoeal disease, the two leading killers of children under five in the developing world. Despite being largely preventable, these diseases kill 1.1 million and 760,000 children every year respectively. Ensuring that safe, effective vaccines reach the communities that need them is a key priority in international development and it rightly forms the backbone of our global health and development efforts.
Despite all of this positive work, I also witnessed something which shocked and concerned me - the lack of adequate sanitation and hygiene practices in some of the clinics I visited. As a microbiologist I understand only too well that access to water, sanitation and hygiene (WASH) is an essential underpinning to any health system. I was alarmed by the thought that the children I had seen being vaccinated could remain at risk from future infection because they simply didn’t have access to basic WASH facilities.
These experiences lead me to think that we need to be more joined-up in our thinking about public health and development. For me, this means not only better integration of project funding and delivery but also more effective communication between the Governments, NGOs and international institutions involved. With this in mind I have been working with the Earl of Dundee, Chair of the Council of Europe Subcommittee on Public Health, to bring stakeholders together to establish how we achieve our goal of greater integration, in particular organisations like PATH and WaterAid who have a real interest and have shown true leadership in this area. Following a roundtable event at the end of October I am convinced that there is a collective will to work together more effectively to achieve better health outcomes for children around the world.
There is also a growing weight of evidence in favour of greater integration and coordination. Earlier this year UNICEF and the WHO published their Global Action Plan for Pneumonia and Diarrhoea (GAPP-D), which recommended an integrated ‘Prevent, Protect and Treat’ approach to reducing the global burden of these diseases. This integrated approach encompasses vaccines, WASH, nutrition and basic treatments like antibiotics. Similarly, a recent Action for Global Health report highlighted the success of joined-up initiatives and called for greater incentivisation for integrated approaches to child health.
My message is a simple one. We don’t need to completely overhaul international development policy to achieve better results. Vertical integrations, such as vaccines programmes, can be highly effective. We just need to look for ways to better coordinate and complement these existing efforts. We teach our children that working together can reap greater rewards than acting alone. It’s high time that we remembered this lesson when trying to save the lives of vulnerable children around the world.
-- Jim Dobbin MP is Co-Chair of UK's All Party Group for Child Health and Vaccine Preventable Diseases
Photo credit: PATH/Heng Chivoan.Read more