A first: European regulators give thumbs up to malaria candidate vaccine

Group of women holding infants.

If licensed, the RTS,S malaria vaccine candidate, when used with other malaria prevention tools such as bednets, could help prevent millions of cases of malaria each year. Photo: PATH/Doune Porter.

A partnership with pharmaceutical company GlaxoSmithKline (GSK), PATH’s Malaria Vaccine Initiative, and research centers across Africa has achieved a significant scientific milestone in the quest to develop a malaria vaccine. GSK’s RTS,S (Mosquirix™) has received a positive scientific opinion from European regulators, bringing it one critical step closer to possible implementation.

RTS,S is the first vaccine against the malaria parasite that has reached this far. This positive opinion is an important step in the process of developing a vaccine for use alongside existing malaria prevention tools, such as bednets, drugs, and indoor residual spraying. The opinion underscores that it is technically possible to develop malaria vaccines, although a number of steps remain before one might be available for use. It also validates the continued investment in next-generation vaccines.

The need for new tools

Despite incredible progress over the last decade, this mosquito-borne disease remains a major public health problem:

  • Nearly half the world’s population is at risk of contracting malaria.
  • The World Health Organization (WHO) estimates that 198 million cases and 584,000 deaths occur annually.
  • The majority of these deaths are among children in sub-Saharan Africa younger than age five.

In addition to the need for robust, predictable, and sustained financing to accelerate the fight against malaria, we need new interventions that address the emergence of resistance to the drugs and insecticides that are used in malaria programs today to help ensure the gains we’ve made are not lost.

Portrait of David Kaslow.

Author Dr. David Kaslow is vice president of Product Development for PATH. Photo: Merck.

RTS,S is the malaria vaccine candidate most advanced in development globally. Final results from a large-scale Phase 3 efficacy and safety trial, published in the Lancet earlier this year, showed that RTS,S helped protect children and infants from clinical malaria for at least three years. In all, clinical trials in the Phase 3 program involved more than 16,000 infants and young children in eight African countries.

Where to from here?

This scientific opinion by European regulators paves the way for WHO to further assess how the vaccine may be implemented in national immunization programs. The organization could issue a policy recommendation as soon as the end of the year. This recommendation would provide additional critical guidance to countries about where, how and under what conditions the vaccine may be used.

Other key steps in the policy and regulatory process include prequalification (another WHO process to ensure that the manufacture of medical products, such as vaccines, meets global standards for quality, safety, and efficacy), procurement and financing decisions by key entities like UNICEF and Gavi, the Vaccine Alliance, and eventually, review by individual African countries to make decisions about whether to license the vaccine and make it available for use within national immunization programs.

While there is still further to go for RTS,S and licensure is not guaranteed, Dr. Kwaku Poku Asante, a principal investigator at the Phase 3 clinical trial site in Kintampo, Ghana, is finding cause to celebrate.

“On behalf of the network of clinical trial sites that provided the data that underpins the opinion, I can say that we are all very proud of how far this vaccine candidate has come,” he said. “While the story is far from over, we have already made history, demonstrating once again the capacity of African research scientists to conduct world-class research here at home and the willingness of African families to contribute to the well-being of their communities and nations.”

To learn more about this milestone, please read the announcement.

Author Dr. David Kaslow is vice president of Product Development at PATH.

Friday Think: why infrastructure investments matter

Man surrounded by paper records with a computer on a desk.

Standardized information systems and strong infrastructures influence national economies, but governments must be willing to invest in them. Photo: PATH/Will Boase.

It’s not enough to make an app for a phone or develop a logistics management information system, you must also have the infrastructure—and the power—to support the technology. And without deliberate infrastructure investments, we risk getting stuck in the past.

To me, one of the defining characteristics of countries that are effectively using technology is the recognition by their respective government leadership that national-level infrastructure and standardized information systems matter if they want to grow their economies. It’s in this atmosphere that true creativity flourishes and local problems meet local solutions.

Kate Wilson

Kate Wilson, director of Digital Health Solutions at PATH. Photo: PATH.

In a recent article in the New York Times, reporter Norimitsu Onishi discusses the challenges faced in sub-Saharan Africa due to an aging infrastructure that is challenged daily to create a sufficient, reliable power supply.

Here’s an excerpt from the article “Weak Power Grids in Africa Stunt Economies and Fire Up Tempers.” Continue reading »

A day in the life of a global health advocate

Jenny Howell in front of the US Capitol Building in Washington, DC.

A passion for policy and global health led Jenny Howell to PATH, where she advocates for US Congressional support for maternal child health, immunization, and malaria control. Photo: PATH/Allie Mooney.

This is how Jenny Howell describes what it’s like to be a global health advocate on Capitol Hill:

So, you have a population, ridden with disease. You have a vaccine that can prevent that disease or an effective drug to treat it. How do you get the support of the influential people who can direct resources and shape policies to get these tools to the people who need them most? How do you get the support of policymakers?

Howell pauses to add this caveat:

You have 20 minutes to make them care.

Jenny Howell is the face of PATH’s US congressional advocacy on Capitol Hill in Washington, DC. She spends her days advocating for evidence-based policies to save the lives of women and children around the world and to stop diseases like malaria.

Supporting global health is an easier sell for some than others. Continue reading »

A very small hero and a lifesaving vaccine

Samba Sibiry and his mother.

Today, Samba Sibiry is growing up strong. In 2007, he became one of the first people to receive the MenAfriVac® vaccine. Photo: PATH.

Samba Sibiry: a hero for meningitis

In 2007, two-year-old Samba Sibiry became a hero. At the time, he had no way of knowing the significance of his role. But the part he played as a toddler was crucial in saving the lives of millions against a scourge that has plagued sub-Saharan Africa for more than 100 years.

One of the first of millions

Samba was one of the first children in the world to participate in a clinical trial of a vaccine against meningococcus type A, the strain most destructive to people living in Africa’s meningitis belt. It’s an insidious disease that can strike anyone, but primarily targets infants, adolescents, and young adults. The disease can damage their brains and spinal cords, causing deafness, mental retardation, seizures, or paralysis.

Thanks to MenAfriVac, millions of people, many of them children like Samba, will now be protected against meningitis. Watch Samba’s story. Video: PATH.

Continue reading »

Friday Think: a vaccine trial with a cosmic twist

The International Space Station.

A view of the International Space Station and Earth from the Space Shuttle Atlantis. Photo: NASA/Crew of STS-132.

Orbiting 249 miles above our terrestrial home is the International Space Station (ISS), the largest peace-time international project in human history. It’s also one of the sites of a year-long experiment involving twin astronauts, Mark and Scott Kelly.

The subject? Flu shots with a twist.

Earlier this year, both brothers received their flu vaccinations. But while Mark stayed home on terra firma, Scott Kelly took a ride up to the ISS for a year-long stint. Both brothers will continue to be studied by NASA researchers to track how extended stays in space affect human immune systems. They’ll receive a second flu shot in November, this time while Mark is on Earth and Scott is aboard the ISS.

Francesco Berlanda-Scorza, a senior technical officer in PATH’s Vaccine Development Program, is keenly aware of the challenges hard-to-reach locations can pose during vaccine trials, let alone one that is miles above the surface of Earth. He shares this perspective after reading a recent article in Time: Continue reading »

Meeting demand: access and equity in reproductive health

Jane Hutchings, Seema Kapoor, and Christopher Brady of PATH share how PATH’s work helps family planning resources reach the most vulnerable populations. Following is an excerpt from an article that originally appeared on the NextBillion health care blog.

Health worker showing an unwrapped male condom.

Around the world, there is increasing demand for family planning products and services. Here, health workers are demonstrating proper condom use. Photo: PATH/Felix Masi.

For decades, governments in low- and lower middle–income countries have been, often with significant development assistance, the primary provider of health care services, including family planning. What happens when public-sector and donor resources cannot meet demand?

Against a backdrop of 1.8 billion young people entering reproductive age—the largest cohort in the history of the world—many governments across the globe are committing to expanding access to contraceptives and family planning services. Yet, public health systems alone cannot keep pace with the growing demand. Beyond the public sector lies the private sector, which consists of nongovernmental organizations, a range of social marketing organizations providing subsidized products and services, and the largely untapped potential of the commercial sector. Using the total market—strategically working across all sectors—is one way to effectively deploy resources to meet family planning needs. . . . Continue reading »

Friday Think: can parks help prevent disease?

Child swinging on swing set.

A new study shows the potential that conservation efforts have on better health. Photo: PATH/Mike Wang.

You might assume that higher rates of respiratory infections occur next to roads that produce environmental risk factors such as vehicle exhaust and increased particulates. However, in the Brazilian Amazon, new roads are linked to fewer cases of acute respiratory infections, likely because roads provide easier access to health care. And yet these same roads are also linked to higher occurrences of malaria.

This prompted researchers to ask the question, “Can we cultivate surroundings to prevent diseases?” In other words: can protected areas like parks help keep people healthy?

Julie Beck of The Atlantic shares a look at a new study that explores the health impacts of rapid land-use change and conservation efforts in the Brazilian Amazon rainforest. The study focuses on three health areas: diarrhea, acute respiratory infections, and malaria. Continue reading »

Why PATH’s growing presence in Uganda is “no accident”

Portrait of Emmanuel Mugisha.

Dr. Emmanuel Mugisha, our country program leader in Uganda, shares why PATH’s work in that country is growing rapidly. Photo: PATH/Lynn Heinisch.

Q: What is contributing to PATH’s growth in Uganda?

A: Our staff and programs have grown tremendously. That isn’t an accident; it’s due to positive, long-term collaborations between Ugandan and headquarters staff.

Girls in light blue uniforms stand before a man writing in a ledger. Photo: PATH/Robin Biellik.

Schoolgirls in Uganda, some still holding their arms, line up to confirm they just received the HPV vaccine. PATH/Robin Biellik.

We’ve welcomed many PATH projects and programs, along with internal and external visitors.

Most importantly, I think that every piece of work we have been asked to do, we have done it efficiently and with great results.

In the last eight years, we have evaluated more than 20 health technologies and products in Uganda—including the widely celebrated Sayana® Press. Continue reading »

A first in 50 years: how a new diaphragm design made its US debut

Editor’s note: We’re celebrating the US product launch of the Caya® contoured diaphragm*—the first new diaphragm design to enter the US market in more than 50 years. PATH, CONRAD, and our research partners designed this single-size diaphragm, originally developed as the SILCS diaphragm, to expand women’s options for nonhormonal contraception.

Here to look back at the development story is SILCS team leader Maggie Kilbourne-Brook, a program officer with PATH’s Devices and Tools Program.

Group of researchers holding diaphragms.

Caya® contoured diaphragm is a new contraceptive option now available in the US. PATH and our partners are working to bring this one-size fits-most diaphragm to more women in low-resource settings. Photo: MatCH Research, South Africa.

The first new diaphragm design in over 50 years

Portrait of Maggie Kilbourne-Brook.

Author Maggie Kilbourne-Brook is the SILCS team leader and a program officer with PATH’s Devices and Tools Program.

The US product launch of the Caya diaphragm is an important step toward introducing diaphragms to a new generation of women who may never have seen or heard of this method.

Like a traditional diaphragm, the Caya, originally called the SILCS diaphragm during development, is inserted into the vagina before sex. It covers the cervix to help prevent pregnancy and is used with a contraceptive gel.

What makes the Caya diaphragm different is that its special features—such as the one-size fits-most design—were based on inspiration and input from women and health care providers. Continue reading »

Strengthening markets for reproductive health needs

Amie Batson, PATH’s chief strategy officer, shares how PATH’s partnerships play a hand in developing and sustaining a market for reproductive health commodities. Following is an excerpt from an article that originally appeared on the NextBillion Health Care blog. 

Two women holding a female condom in packaging.

PATH and our partners talk with women all over the world about reproductive health options. Photo: PATH.

I believe—as do my colleagues at PATH—that every woman around the world, no matter where she lives, should have access to options to meet her reproductive health needs. Access to these options—characterized by the widespread availability of well-designed, high-quality, acceptable, and affordably priced products—relies upon strong, healthy markets.

Portrait of Amy Batson.

Amie Batson is chief strategy officer at PATH. Photo: PATH/Patrick McKern.

So what do we do differently in low- and middle-income countries?

In these settings, there are frequently many intermediary funders, which creates additional uncertainty about the size and growth of a market. Coupled with this uncertainty, these markets are typically characterized by low profit margins and high-volume needs, so the economics have to line up just right in order to support development and production and ensure sustainability. Continue reading »