The New York Times, October 2015
"What if there were a remedy that could save more children...
This post is part of the #ProtectingKids blog series. Read the whole series here.
While on a visit to a district hospital in Hoa Binh Province, Vietnam, in the summer of 2013, I saw a newborn baby boy lying with his mother in the hospital. Although the hospital had available stocks of hepatitis B birth-dose vaccine, I learned that the doctor did not vaccinate him. This left the infant at risk of mother-to-child transmission of hepatitis B and the chronic infection and complications it can cause later in life, such as liver cancer.
The baby missed his chance for protection because of general fear, confusion, and misinformation about vaccines. That summer, a flurry of negative media attention about vaccine safety had led to steep drops in immunization coverage for hepatitis B and many other vaccines. As I witnessed in Hoa Binh Province, one of the key factors was that many physicians, nurses, and midwives working in provincial and district hospitals were unsure of their responsibility to deliver vaccines to newborns and children to protect them from hepatitis B and other childhood diseases. Thisresulted in outbreaks of measles and Japanese encephalitis in Vietnam.
While Vietnam had long had a robust National Expanded Program on Immunization (NEPI), the situation in 2013 was paralyzing the immunization system. It revealed opportunities for improvement in the way that the Ministry of Health (MOH) manages, distributes, and communicates about vaccines.
This was especially important to address as Vietnam will soon graduate from the support of Gavi, the Vaccine Alliance and will need to sustain vaccination services on its own. Additionally, several new lifesaving vaccines—rotavirus, pneumococcal, and HPV—have not yet been introduced into Vietnam’s routine immunization system, and vaccines remain uncovered by public health insurance, making them too expensive for many families.
The opportunity: A Decree on Immunization
Recognizing all of this, the MOH decided to develop a Decree on Immunization—a law that would reform, restructure, and strengthen the immunization system. Because of PATH’s long history of providing technical assistance and strategic support for important child health policies, the MOH called on PATH to help develop the decree. I was pleased to get this opportunity to help create a policy that can improve vaccine access and help save more children’s lives.
Over the past year, PATH’s expertise in delivery and regulation of vaccines in the Mekong region has helped inform and influence the design of a new system. With financial and technical support from PATH, the first draft of the decree was finalized in late 2014 and is now under review by the MOH and other relevant ministries. It will also be circulated to collect public opinions before final approval.
I am grateful to the MOH for acknowledging this important and lifesaving Decree on Immunization for the health of the Vietnamese people. I am confident that, once enacted, the decree will provide a framework to improve vaccination coverage and strengthen the NEPI and the broader health system.
Vaccines save lives. My dream is that, with the needed reforms in place, babies like the one I saw in Hoa Binh Province will receive the protection they need to live long and healthy lives.
This post is part of the #ProtectingKids blog series. Read the whole series here.Read more
This post is part of the #ProtectingKids blog series. Read the whole series here.
“During the day, he is an angel. But during the night, he really gives me hell.”
We may as well have been two friends catching up over coffee. In actuality, we had just met and were in a makeshift interview space in small side room of Chainda Health Centre in Lusaka, Zambia. I scribbled on a notepad; Teresa balanced a newly updated vaccination card and her one month old son, Vusi, sleeping peacefully underneath several fluffy white layers of tiny clothes and blankets.
Vusi had just received his DPT vaccine and his rotavirus vaccine. It was 2012, and the rotavirus vaccine was new for Zambia. The government, with support from Gavi, the Vaccine Alliance, was piloting the vaccine introduction in Lusaka Province before rolling it out across the rest of the country as part of an integrated prevention and treatment approach to drive down the diarrhea burden.
The nurses told our DefeatDD team that mothers were thrilled when they heard about the rotavirus vaccine, and Teresa was no exception. She recounted her moments of fear and helplessness with her first son, who she rushed to the hospital again and again with severe diarrhea. “I was a first-time mother, with no relatives nearby, and I didn’t know what to do. He was near death at times, had lost his appetite, and all this has affected his growth also.”
Cognitive dissonance: That’s the best way I can describe how her story struck me, because there were many ways in which I related to Teresa. She was well-educated, earning a steady income as a schoolteacher. She owned a TV and an indoor toilet, and seemed to enjoy a comfortable living. And yet in her country, diarrhea causes one out of every five child deaths, whereas in mine that number is virtually zero.
After four years advocating for rotavirus vaccine introduction in developing countries, Vusi was the first child I ever met who had received the vaccine.
The silver lining in her scary trips to the hospital with her first son were the lessons Teresa learned there about diarrhea prevention and treatment. She enthusiastically explained the steps for preparing oral rehydration solution, as well as the importance of simple precautions, like washing her hands after she changes the baby’s diaper and before she prepares food. “Because these little things are the things that affect babies and expose them to diarrhea and other infections,” she said.
When Teresa learned about the rotavirus vaccine, she did not hesitate. She rushed her older son to the clinic, only to learn that he was too old to receive the vaccine. But it brought her joy to know that Vusi would be eligible for protection. “I’m very glad this vaccine has come to help our babies, because diarrhea is one of the major problems we face here in Zambia.”
With the formal portion of my Q&A over, I turned to my favorite part of our interview: asking Teresa her hopes and dreams for Vusi as he grows up.
She considered it thoughtfully for a moment before she answered, “Much as I can have plans for my children, when they grow they will have their own analysis of things and their own way of thinking. But for my side, I would love him to become a responsible man and also care for his children like I cared for him.”
“He’s very lucky to have you,” I told her.
“Yes.” She smiled coyly down at her little bundle, now protected from the life-threatening diarrhea his older sibling suffered. “Yes, he is very lucky, in fact.”
For more information:
- Read Teresa’s story and others in the DefeatDD series, “Together Against Diarrhea”
Photo credits: PATH/Gareth Bentley.Read more
Me in December 1991, just a few weeks before getting sick.
This post is part of the #ProtectingKids blog series. Read the whole series here.
There was once a healthy little girl who, just a few months before her second birthday, started to feel sick. Her tummy hurt, her forehead began to burn up, and then aggressive diarrhea and vomiting started. The girl became weak, pale, and severely dehydrated: although the girl was crying, her tears had stopped flowing. She was listless and limp, lying on the couch like a rag doll.
Her parents tried both juice and Pedialyte, a type of oral rehydration solution (ORS), but nothing would stay down. They were terrified. After 36 hours, they decided to bring her to the hospital. Doctors ran a few tests and quickly determined that the diarrhea was due to rotavirus. Since there is no treatment for rotavirus other than rehydration, they gave her intravenous (IV) fluids—a feat for the nurse, given that the girl’s dehydrated veins were so tiny.
That girl was me in January 1992. I only learned the full story recently. I had known I was hospitalized as a toddler, but I had no idea it was due to rotavirus, and I had never heard my parents’ testimony of how horrible it was. This came as a surprise because, at the time I learned about it, I had been working at PATH for about a year on rotavirus vaccine advocacy and communications. I had been telling my parents about our newest projects when my dad remarked:
“We felt so helpless when you had rotavirus.”
“Wait… what?!” I said, stunned.
The rest of the story takes a more positive turn—my parents said I began to feel dramatically better after the first day in the hospital. My color brightened, my tears returned, and my fever dropped. On the second day, when it was time for my dad and sister to go home after a visit, I determined, "I go too!" and tried to rip my IV catheter out of my arm. “I(B) out!”
Much to my parents’ relief, I only stayed in the hospital for two nights, returning home on the third day. I fully recovered thanks to the IV fluids.
My mom’s entry in my baby book describing the incident.
After learning about this, there was first the mindboggling realization that the disease I had been researching and writing about every day had touched my family and me personally, and I had had no idea. Not only had rotavirus sent me to the hospital, it had also forced my mom to miss two days of work and cost my family a lot of stress and expenses.
I then had the revelation that the little girl described above could be almost any little girl or boy, anywhere in the world, whether decades ago or today. Rotavirus is called a “democratic” virus—without protection from vaccines, rotavirus infects nearly all children everywhere, rich or poor, by the age of five and is the most common cause of severe diarrhea in the world. It does not matter if you are in the United States or Nepal, if you live in a mansion or a grass hut, or if you drink water from a river or a well: rotavirus is everywhere.
In many places in the world, however, a child in the same situation I was in may not be able to go to the hospital, or even if she is, the hospital may not have ORS or IV equipment. In those situations, diarrhea can become a death sentence. Rotavirus alone is estimated to cause hundreds of thousands of deaths—the vast majority in Africa and Asia—and millions of diarrhea-related hospitalizations in children under five each year. I am unimaginably lucky that my parents were able to get me the proper treatment. Without the IV fluids, they might have lost their little girl.
This is why rotavirus vaccines are so crucial. They are the best way to protect kids from rotavirus and the deadly, dehydrating diarrhea it can cause. First introduced in seven countries in 2006, rotavirus vaccines are now available in the national immunization programs of more than 75 countries worldwide, nearly half of which are lower-income countries supported by Gavi, the Vaccine Alliance.Where children have access to them, rotavirus vaccines are saving lives, money, and a lot of parental grief.
Let’s keep advocating until everyone, everywhere can be protected, because no parent should have to see his or her child suffer from a disease that is now vaccine-preventable.
My parents couldn’t agree more.Read more
To ensure a vaccine is safe and effective, it must be carefully studied in the laboratory and go through several rigorous phases of clinical trials. If safety is not assured at any point, the vaccine candidate simply does not advance. Photo: PATH/Gabe Bienczycki.
You may not know that the DefeatDD team is housed within PATH's Vaccine Development Global Program, since our diarrheal disease advocacy originated with rotavirus vaccines. Today, we advocate for an integrated approach, including other vaccines against diarrheal disease that are on the horizon. Here, John Donnelly, director of our Vaccine Development Program, describes the rigorous research that goes into ensuring a vaccine's safety and efficacy. This post was originally featured on the PATH blog.
Before a drop of an oral immunization reaches a newborn’s mouth or a syringe delivers a first shot, vaccines have cleared a multitude of hurdles, each carefully designed to ensure that they are safe and effective.
“It takes a village to raise a child,” the saying goes, and one of the first instances of collective care a child receives is immunization. Bringing a vaccine through research and into the clinic or field takes a veritable village of scientists, experts, and ethicists, and a rigorous process that ensures they collaborate at the highest standards.
My role as director of theVaccine Development Program at PATH, and a long career in vaccine research and development, have afforded me valuable insight on the need for vaccines throughout the world and the commitment of scientists in making sure vaccines safely protect our children.
From the initial stages of early research and clinical development through regulatory approval and use, vaccines are painstakingly evaluated for safety and efficacy. By the time a physician prepares an injection and administers it to stimulate a child’s immune system, the vaccine contained within has been carefully studied in the laboratory and through several phases of clinical trials.
Each phase builds on the information received from the previous one, and if safety is not assured at any point, the vaccine candidate simply does not advance.
PATH and our partners led an 11-year effort to turn a little-known vaccine from China into an internationally approved tool to fight Japanese encephalitis. By 2017, the JE vaccine is expected to reach nearly 290 million people—a turning point in the battle to protect children from this dreaded disease. Photo: PATH/Satvir Malhotra.
A trial’s researchers aren’t the only ones to evaluate vaccine safety: expert, independent advisors make pivotal contributions throughout.
Ethical committees, independent safety review boards, and regulatory agencies—among these the US Food and Drug Administration and its counterparts in other countries—must approve a trial’s design before it commences.
Each trial incorporates multiple levels of oversight to ensure the safety of its subjects. These groups join safety monitors and local community advisors in routinely checking standards, ensuring informed consent, and reviewing data collection. They evaluate all reported adverse events, both expected and unexpected, their severity and frequency, and whether such events call for halting the trial.
From this village of scientists and experts, ultimately we derive our intended impact—affordable, safe and effective vaccines for all children around the world, and particularly those in villages themselves: rural communities where the luxuries of our everyday lives aren’t available to help keep kids healthy.
In communities where safe drinking water, access to routine health care, or appropriate nutrition are beyond reach, immunization may be the only health intervention that is both affordable and effective. Even today, children are suffering needlessly from diseases that we know vaccines can prevent. With infectious diseases like polio, measles, and Haemophilus influenzae type b all but eradicated in the US, many have forgotten how threatening and devastating they can be.
A mistaken interpretation of the risks and benefits of vaccination may lead some parents to incorrectly conclude that the vaccines themselves pose a greater risk than the diseases they prevent. When vaccines spare us from fear of disease—a reassurance that can too easily lead to complacency—lack of attention to vaccination can allow the diseases to return, causing needless illness and death.
Where pneumonia, diarrhea, measles, influenza, and other vaccine-preventable diseases are still viewed as a common, lethal threats, the promise of vaccines takes on vital value and priority among families.
And for those who graciously participate in vaccine trials, researchers provide comprehensive information when requesting their consent for enrollment and sharing background about the disease, the vaccine candidate and manufacturer, risks, benefits, and how the clinical trial will be conducted.When our team and partners select clinics and communities to participate in large vaccine field trials—culminating steps in the long process to demonstrate safety and efficacy—we find that parents are eager to help investigate a vaccine that could literally mean the difference between life and death.
After clinical trials, once a vaccine has demonstrated appropriate safety and significant potential for preventing disease, after it is licensed and put into practice, the science continues.
Effectiveness studies allow us to see direct real-world impact as well as the value of herd immunity, which emphasizes the urgency to immunize children eligible for vaccination to better protect those who cannot be vaccinated because they are too young or their immune systems are compromised.
Routine surveillance shows us how well vaccines perform but also how rapidly risk can rise when families forego immunization.
Manufacturers and public health authorities monitor the experience of many thousands of children over many years to identify adverse events that are potentially related to vaccination but so rare that they may never appear in clinical trials. Ongoing evaluations of these very rare adverse events occurring in both vaccinated and unvaccinated populations, together with other data collected in post-marketing studies, enable us to further define vaccines’ real-world risk/benefit ratio.
Clinical studies are crucial steps along the journey to make sure that every child is protected from vaccine-preventable diseases. Careful study allows PATH and our partners to ensure that new vaccines are safe and effective and ultimately close gaps in access to lifesaving immunizations.
By also strengthening health systems, accelerating research and development, and creating innovative technology solutions, PATH is working to make safe and effective vaccines affordable and available to all families.Read more
The 50 kilometer drive from Phnom Penh to Ponhea Leu, Kandal province took a good two hours, reminding me of similar roads in India. In Cambodia, on an assignment for Amplify Markets to support businesses providing WASH solutions to low income consumers, it’s difficult not to draw comparisons with the situation back home.
Both countries face the same challenges in sanitation where availability of affordable toilets is limited. Organizations like IDE have been supporting small toilet businesses to address this gap.These providers are still learning basic business skills and lack access to capital. On the demand side, in both countries, there is an absence of formal savings by low-income families. This leaves families without the cash flow to purchase big ticket item like a toilet and adoption remains constrained. Both countries leverage microfinance loans to address this, but funds for such loans remain limited. Low-income families in both India and Cambodia aspire to have a ‘nice’ toilet with septic tanks. This limits demand for viable and affordable technologies like leech pits, while people wait to be able to afford a nice toilet.
A relief for Cambodia, though, is its lower density of population compared to India, where dense populations face space constraints for toilet construction. During my short stay, what was evident was the dependence on external stakeholders. Cambodia has a high number of international NGOs dependent on foreign aid and expats. This has translated into a lack of ownership of their programs by local communities, which is likely to pose a problem for transition from aid to self-reliance. Because of this, I feel it is imperative to use grant funds to build capacity of solution providers (like sanitation businesses) and knowledge of consumers rather than just give away WASH products.
Interestingly, in my interactions I could not help wondering what was helping things along in Cambodia. Being a matriarchal society it was far easier in Cambodia to approach women, who in any society are more sensitive to issues concerning the family’s health. This definitely has a spin off for sanitation and makes it much easier to communicate the benefits of a toilet to the family. Once women were convinced they needed toilets, they took the decision to buy as opposed to India where male members of the family are the purchase decision-makers for expensive items like toilets. Hence, convincing a family in India to adopt a toilet means convincing two or more people and makes the exercise more difficult.
Cambodia, like India, is one of the countries in the world where the vast majority of deaths from diarrhea occur. Low-income families in both the countries are at risk as a result of open defecation and lack of access to safe water or to lifesaving treatment. Coming back to bad roads: WASH products - toilets, water filters and others will obviously cost more in Cambodia too, because of the high logistics costs due to bad roads.
At this point awareness is simply not enough. Consistent supply of good quality and affordable toilets will help both countries inch towards their MDGs.
-- Tanya Mahajan has been working in the WASH sector for the past five years. She is the co-founder of Zariya, a development consulting firm that leverages businesses as a way to increase access to safe water and appropriate sanitation.
Photo credits: Tanya Mahajan/PATH.Read more