Times of India, May 2013
A pivotal clinical study of India's first indigenous rotavirus vaccine...
Sometimes history is made at the ballot box, sometimes on a battlefield. Today it was made in a hotel ballroom. That is where I was able to witness an historic breakthrough as the Indian Government and Bharat Biotech announced positive results from a Phase III clinical trial of a rotavirus vaccine developed and manufactured in India.
I was one of many at the International Symposium on Rotavirus Vaccines for India—The Evidence and the Promise to learn that ROTAVAC® is safe and protects children against rotavirus infections, the most severe and lethal cause of childhood diarrhoea.
Of course, the ballroom wasn’t really where history was made – just where we heard about it. It really happened in hospitals, scientific laboratories, vaccine production lines, and health clinics.
The idea for an Indian-based rotavirus vaccine arose in the mid-1980s, when two different groups of scientists working in India discovered unusual strains of rotavirus that infected newborns in hospital nurseries but didn’t make them sick. Dr. M.K. Bhan, who later became the Secretary of India’s Department of Biotechnology (DBT), was among the scientists at the All India Institute of Medical Sciences who discovered one of these strains, called 116E, during routine diagnostics of newborns in New Delhi.
Dr. Bhan went on to lead a global team contributing to the development of a vaccine using the 116E strain that included scientists and health experts across several Government of India agencies, the Society for Applied Studies in India, Bharat Biotech International, Ltd., Stanford University School of Medicine, the US National Institutes of Health, the US Centers for Disease Control and Prevention, and PATH. Dr. Bhan, along with his colleague, Dr. T. S. Rao, was tireless in fostering the social innovation partnership and ensuring the highest standards for the vaccine that is now called ROTAVAC®.
Along the way, PATH was pleased and privileged to be one of the partners contributing to this public health effort, and we are now tremendously excited by these scientific results. This vaccine, if licensed, has the potential to save the lives of thousands of children each year in India.
We congratulate Dr. Bhan and all his colleagues in the Government of India, Bharat Biotech, and the diligent group of researchers who were the principal investigators for this pivotal clinical trial, as well as all of the dedicated and visionary individuals and institutions who helped make history today.Read more
One year ago this month, the plans were well underway – plenty of ideas, not too many specifics, and uncontainable excitement: The defeatDD team was heading to Zambia!
I had actually been once already, before joining PATH. Nine years prior, my team at Columbia University gave me the chance to help convene clinicians from around the continent to share their stories—the highs, lows, and logistics—of providing antiretroviral therapy to patients living with HIV. Zambia had proven to be a leader in HIV prevention and treatment. Not long after, Zambia became a model in malaria control. And last year, Zambia established itself as a pioneer in conquering yet another major health obstacle—protecting children from deadly diarrhea.
We are indebted to the many gracious hosts who welcomed the defeatDD team to Zambia last year, not to mention the warm and inviting PATH office in Lusaka. Several organizations not only shared with us their stories, they inspired us to share these stories with you. With two new videos produced and released in recent weeks, we are thrilled to highlight the dedicated work of our esteemed colleagues—our friends—at the Ministry of Health; the Centre for Infectious Disease Research, Zambia; Africare; Water & Sanitation for the Urban Poor; and Lusaka Water & Sewerage. And don’t miss our profile of the innovators at ColaLife!
Schools are cosmopolitan meccas for all types of bacteria and viruses. Whether in the United States, Haiti, Malaysia, or Angola, schools are breeding grounds for a dangerous mix of recurring gastrointestinal illness. The sheer amount of children with underdeveloped immune systems situated in a small space, sharing food, materials, and sanitation facilities makes for a public health perfect storm.
Recent statistics from UNICEF demonstrate that “more than 40 percent of diarrhea cases in schoolchildren result from transmission in schools rather than homes.” Accordingly, the impact of diarrhea and gastrointestinal illness on education is direct. Students that lack access to adequate sanitation facilities, soap for hand washing, and potable water to drink in schools are exposed and vulnerable to fall sick with parasite infection and diarrheal disease. These students then miss critical school days, which is exacerbated within education systems that are already underserved and underperforming. UNICEF also presents a solution to the public health perfect storm in schools that it recognizes: “Hand washing practiced in facilities such as day-care centers and primary schools reduces cases of diarrhea by 30 percent.” WASH in Schools, otherwise known as water, hygiene, and sanitation services, are therefore an important service to building a healthy and productive student body.
WWR Program Manager and Director explain the benefits of drinking and handwashing stations in the schools and how they are not only for the students but that in each school, there is one for the community as well.
World Water Relief focuses on implementing WASH in Schools projects in Haiti and the Dominican Republic to create a hygienic, healthy, and safe learning environment. Our projects feature safe water, hand washing, and improved sanitation that represent an immense opportunity to reduce the diarrheal illness that millions of students battle every day. To ensure long-term impact and sustainability of our projects, we especially focus on ensuring that kids bring their lessons beyond the typical classroom. From engaging students to sing songs about water in the classroom, to teaching parents to practice hygiene at home, to teachers being a role model and washing their hands with students side-by-side, we believe that long-lasting impact occurs when students, teachers, and their parents are all involved. Instead of seeing the school environment as a dangerous breeding grounds for bacteria, we must embrace the opportunity that this platform provides by improving appropriate WASH infrastructure to vastly improve the overall health and productivity of students around the world.
-- Ben Seidl, Program Director, World Water Relief
Photo credits: World Water ReliefRead more
Dr. Mark Alderson is the director of the pneumococcal vaccine project at PATH. Since 2006, his team has been advancing the development of vaccines tailor-made to protect the world’s poorest children from pneumonia—a disease that, together with diarrhea, claims more than two million lives each year. We sat down with him to get insights into strategies that could be child survival game-changers for the future.
As the global health community mobilizes around an integrated strategy to take on the top two infectious diseases threatening children today—pneumonia and diarrhea—what is important to know about pneumonia?
Pneumonia is the leading cause of child deaths worldwide, killing roughly 18 percent of children under age five. Multiple causes of pneumonia exist, but the most common and deadliest is the pneumococcus bacterium, responsible for close to half of the cases of pneumonia in children. Overall, investment in an integrated strategy that combines vaccines, treatments, clean air, and proper diagnosis can bring pneumococcus and other causes of pneumonia under better control—with even greater improvements for child survival if further integrated with diarrhea control efforts.
What is being done to prevent pneumococcal disease and how is the project that you direct contributing?
On the vaccine front, two licensed pneumococcal vaccines exist for young children. They are quite effective against 10 and 13 of the more than 90 varieties of pneumococcus. Groups like the GAVI Alliance have made remarkable progress in helping low-resource countries introduce these vaccines relatively quickly. However, there is still an urgent need for inherently more affordable and broadly protective vaccines targeted to children in the developing world where most of the pneumococcal deaths occur, and this is where our project is advancing the development of new vaccines.
Why are additional vaccines needed and what does an ideal pneumococcal vaccine for the developing world look like?
Current pneumococcal vaccines save many lives, but are not designed to cover all pneumococcal varieties. They are also difficult for low-resource countries to afford without substantial help. An ideal new vaccine would be easy to make, inherently affordable for even the poorest populations, and offer broad coverage across all pneumococcal varieties.
What’s an example of a vaccine currently in development that could achieve this goal?
We’re particularly excited about the potential of a novel killed pneumococcal whole cell vaccine that we’ve been working on in partnership with Boston Children’s Hospital. This vaccine has been effective in preclinical models and recently completed a Phase 1 clinical trial designed to demonstrate safety and immunogenicity. This whole cell vaccine targets proteins common across all pneumococcal varieties and should be very affordable. If it pans out the way we hope, it could eventually be the standard in the developing world.
Who needs to come together to make a vaccine like this possible?
In advancing a novel vaccine designed for the developing world, rather than for the industrialized world, we are treading on new territory and need a lot of people to come together. We started with a small number of development and research partners, but will need to bring in other collaborators such as manufacturers, regulatory authorities, international organizations, and target countries as we move forward.
What has to happen to ensure access for children in low-resource countries?
Our long-term strategy is to get the vaccine licensed in a high-burden, low-resource country and then gain World Health Organization prequalification that will enable procurement of the vaccine in the developing world. We go through careful partner selection and negotiation processes to ensure alignment of global access goals with our partners. We also work with developing-country manufacturers that can make vaccines available to underserved populations at a low price.
As we look forward to new developments in vaccines, what key opportunities do you see for tackling pneumonia and diarrhea now?
Children get a lot of vaccines now, so one of the things we can do is find ways of integrating pneumonia and diarrhea vaccine strategies into routine immunization programs. Beyond vaccines, leveraging common resources for improving access to treatment, clean air, and sanitation is critical. So is continuing to build public awareness that these are the top killers of kids and that the recipe for success is to tackle them together, with equal vigor.
For more information:
-- Learn about the GAPPD, the new global strategy by WHO and UNICEF to simultaneously tackle pneumonia and diarrhea.
Photo credit: Richard FrancoRead more
We can prevent 95% of deaths from diarrhea and 65% of deaths from pneumonia by scaling up cost-effective interventions. How cool is that? That was the bottom line from US AID’s briefing about the Integrated Global Action Plan for the Prevention and Control of Pneumonia and Diarrhoea (GAPPD). Speaking at the event, Samira Aboubaker of the World Health Organization (WHO) invoked US President Obama’s campaign slogan, “yes, we can.”
So, the next challenge is to turn yes, we can into yes, we will.
While the GAPPD from UNICEF and WHO maps out the key steps that are needed, it will be up to national governments to actually take those steps. They will need the help of civil society organizations (CSOs), nongovernmental organizations (NGOs), donors, multilateral institutions, and the private sector. CSOs and NGOs have an important role in keeping attention on the GAPPD and its implementation. Because the effort now shifts to what will change within countries of high burden, PATH partnered with World Vision International to compile an Advocacy Tool Kit for our colleagues and allies working in country.
We hope the toolkit will help CSOs, NGOs, and other advocacy groups or individuals to advocate for the successful implementation of the GAPPD. In addition to concrete tips and tactics, it includes links to useful resources, and templates for creating effective materials tailored to local needs.
When our team first heard rumors that the work was underway on the GAPPD, we were quite excited. You might find that strange and suggest we need a bit more excitement in our lives (and you might be right) but what an opportunity to focus attention on these two leading killers of children under five and the solutions needed to significantly reduce the death and illness they cause. And it turns out, we’re in good company with the over 100 organizations and pediatric societies expressed their enthusiasm by signing the statement of support.
We know from our work in Cambodia and Kenya, among other places, that governments are eager to bring together the right package of solutions to protect children from diarrhea and pneumonia. We are excited that advocates everywhere can use the GAPPD and the Advocacy Toolkit to bring these ideas to the countries and communities most in need.Read more