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May 25, 2012

Rwanda introduces rotavirus vaccines to save children from deadly diarrhea Rollout of rotavirus vaccines across Africa continues
Rwanda today became the third GAVI-eligible African country to introduce vaccines against rotavirus, the leading cause of severe and deadly diarrhea in young children. Rotavirus is responsible for close to 3,500 deaths in children under five years of age every year in Rwanda, which amounts to 8.8% of all under five deaths nationwide. Vaccines are the best way to protect children in Rwanda and the rest of the world from severe rotavirus disease and the deadly dehydrating diarrhea that it causes. Now that Rwandan children will have access to life-saving rotavirus vaccines, much of this death and suffering can be prevented. "Introducing rotavirus vaccines gives us the opportunity to save many lives and to reduce the impact of illness on our hospitals and within our communities," said Maurice Gatera, EPI Manager, Rwanda Ministry of Health. Burden of rotavirus in Africa
Children in Africa bear the heaviest burden of rotavirus disease—approximately 40 percent of children hospitalized for diarrhea test positive for rotavirus. Nearly 50 percent of the more than 450,000 deaths annually from rotavirus occur in Africa where access to treatment for the deadly dehydrating diarrhea caused by rotavirus is limited or unavailable. Rotavirus surveillance was initiated in Rwanda in October 2010 to track the burden of rotavirus disease. The Ministry of Health is working to strengthen the surveillance system to effectively monitor the impact of vaccine introduction on child deaths and hospitalizations. Expected impact of rotavirus vaccines in Rwanda
In April 2009, Rwanda became the first developing country to introduce pneumococcal vaccines into its routine immunization program, which led to a significant decline in respiratory infections. Ministry of Health officials expect the introduction of rotavirus vaccines have a similar dramatic impact on the incidence of severe infant diarrhea as it has in other countries already using the vaccine. GAVI support for rotavirus vaccines in Africa
With widespread use of rotavirus vaccines, we can drastically reduce the numbers of young children who are hospitalized or die from severe diarrhea and greatly improve child health in the developing world. Rwanda is the third African country to utilize GAVI support for rotavirus vaccine introduction after Sudan (July 2011) and Ghana (April 2102). This brings to seven the total number of GAVI-eligible countries that have introduced rotavirus vaccines. GAVI plans to vaccinate more than 50 million children in 40 of the world’s poorest countries by 2015 and last year approved an additional 16 countries—12 in Africa—for rotavirus vaccine support. Last month, GAVI announced it had secured low prices on rotavirus vaccines from both GlaxoSmithKline (GSK) and Merck & Co. Inc. (Merck), the two manufactures with licensed and approved rotavirus vaccines. While the first six GAVI-eligible countries introduced GSK’s Rotarix® vaccine into their national immunization programs, today’s introduction in Rwanda marks the first rollout of Merck’s RotaTeq® vaccine in a GAVI-eligible country. In developing countries such as Rwanda, where the toll of rotavirus disease is devastating, GAVI’s support for the affordable and financially sustainable introduction of rotavirus vaccines in national immunization programs will make a significant impact on global efforts to achieve Millennium Development Goal 4, the reduction of child mortality.

April 24, 2012

Rotavirus vaccines projected to save more than 2.4 million lives in developing countries by 2030 Special supplement to the journal Vaccine provides critical insights to maximize vaccine impact in low-resource settings
Rotavirus vaccines offer the best hope for preventing severe rotavirus disease and the deadly dehydrating diarrhea that it causes, particularly in low-resource settings where treatment for rotavirus infection is limited or unavailable, according to studies published in the April 2012 special supplement to the journal Vaccine. The special supplement, “Rotavirus Vaccines for Children in Developing Countries,” summarizes data on the performance of rotavirus vaccines to help maximize their impact in developing countries, which stand to experience the greatest overall public health benefit from the introduction of rotavirus vaccines due to their extremely high rates of severe rotavirus disease and death. Swift and significant declines in hospitalization and deaths due to rotavirus and all causes of diarrhea have been observed in many of the 30 countries that have introduced rotavirus vaccines into their national immunization programs to date. The studies in the supplement provide critical insights on factors that contribute to varying efficacy of rotavirus vaccines in different populations, and add to the growing body of evidence demonstrating that rotavirus vaccines are a safe, proven, cost-effective intervention. The GAVI Alliance recently secured a new low price of US$2.50 per dose for rotavirus vaccines, which enables GAVI to respond to developing country demand for this lifesaving intervention.
figure 1. More than 2.4 million lives saved in developing countries by 2030

More than 2.4 million lives saved in developing countries by 2030
Supplement Highlights
Highlights of the findings in “Rotavirus Vaccines for Children in Developing Countries” include:

  • Rotavirus vaccines are highly cost-effective and are projected to substantially reduce child deaths. In GAVI-eligible countries, where 95 percent of deaths due to rotavirus occur, more than 2.4 million child deaths can be prevented by 2030 by accelerating access to lifesaving rotavirus vaccines.
  • Each year in GAVI-eligible countries, use of rotavirus vaccines could prevent an estimated 180,000 deaths and avert 6 million clinical and hospital visits, thereby saving US$68 million in treatment costs annually.
  • Rotavirus vaccines significantly reduce serious rotavirus disease and save lives in rural settings, where children often die from rotavirus infection because access to lifesaving rehydration treatment for severe rotavirus-related diarrhea is limited or unavailable.

“Rotavirus causes more than 450,000 deaths each year in children under five and is responsible for millions of hospitalizations and clinic visits. A better understanding of the science and performance of rotavirus vaccines allows developing countries, which shoulder 95 percent of the global death toll from rotavirus, a vital opportunity to save more lives,” said Dr. Kathy Neuzil, co-editor of the supplement and incoming Director of the Vaccine Access and Delivery Global Program at PATH. PATH: Maximizing Impact of Rotavirus Vaccines PATH’s commitment to maximizing the impact of rotavirus vaccines in low-resource settings and accelerating their access to children most in need is longstanding and resolute. First under the GAVI-supported Rotavirus Vaccine Program (RVP) (2003-2009), and now as part of the GAVI-supported Accelerated Vaccine Introduction initiative (2009-present), and the Bill & Melinda Gates Foundation-supported Rotavirus Vaccine Impact project, PATH has been instrumental in the design and conduct of rigorous scientific studies to demonstrate safety, efficacy, impact, and cost-effectiveness of rotavirus vaccines. Dr. Neuzil, who served as Clinical Director of RVP, provides a first-person account of PATH’s efforts to increase the scientific evidence base to support policymaker and donor decision-making around the acceleration of access to and delivery of rotavirus vaccines.

June 6, 2011 Substantial Price Reductions for Rotavirus Vaccines for GAVI-eligible Countries In the lead-up to GAVI’s pledging conference on June 13, 2011, multinational and emerging market manufacturers offered steep price cuts on rotavirus vaccines and other GAVI-supported vaccines. The substantial price reductions coupled with the expected high number of rotavirus vaccine applications from GAVI-eligible countries will maximize GAVI’s ability to provide life-saving rotavirus vaccines to children in the world’s poorest countries.

GlaxoSmithKline has offered to supply up to 125 million doses of its Rotarix® vaccine over five years to the GAVI Alliance at US$2.50/dose ($5.00/course), which is approximately a 95% reduction to the Western market price and a 67% reduction from the lowest price available on the public market today. Merck has offered to supply its RotaTeq® vaccine to the GAVI Alliance at $5.00/dose ($15.00/course), with the purchase price decreasing to $3.50/dose ($10.50/course) once the purchase volume increases to 30 million doses. Bharat Biotech (pdf) has offered a future price to the GAVI Alliance of $1.00/dose ($3.00/course) for ROTAVAC®, its rotavirus vaccine currently in Phase 3 clinical trials, which is anticipated to be ready for purchase through UNICEF by 2015. The Serum Institute of India and Shantha Biotechnics, a subsidiary of Sanofi Pasteur, are also developing rotavirus vaccines for GAVI-eligible countries. Part of GAVI’s 2011–2015 strategic plan includes market-shaping activities (PDF) to minimize the cost of vaccines to GAVI and eligible countries, while providing a sufficient and uninterrupted supply of high-quality vaccines and fostering an environment for innovation. The reduction in vaccine prices achieved by GAVI reflects the power of pooled procurement and predictable financing. Helen Evans, GAVI’s interim CEO, welcomed the manufacturers’ commitment to lower prices and stated that "if rotavirus vaccine could be purchased this year at a $2.50 price, the impact on public health could be significant and would allow GAVI to save approximately $500 million through to 2020, or about $140 million through to 2015." The PATH Rotavirus Vaccine Trials Partnership is a collaboration between PATH, the World Health Organization, the US Centers for Disease Control, clinical study sites, and vaccine manufacturers. The partnership's activities are funded by the GAVI Alliance. For background information on rotavirus and diarrheal disease, please see www.rotavirusvaccine.org and www.defeatDD.org. For background information on the GAVI Alliance's support for rotavirus vaccine introduction, see www.gavialliance.org

March 23, 2010

US FDA: Evidence of porcine circovirus in rotavirus vaccine does not pose public health risk The US Food and Drug Administration (FDA) has temporarily suspended use of the Rotarix® rotavirus vaccine, pending further investigation of the presence of porcine circovirus within the vaccine. Porcine circovirus is commonly found in meat and other food products, and is not known to cause disease in either humans or other animals. The FDA stressed that there is no evidence of an associated health risk. An investigation by the European Medicines Agency similarly concluded that there is no evidence of a public health risk, and the World Health Organization concurred with both the FDA and the European Medicines Agency. While rotavirus occurs worldwide, developing countries suffer the greatest burden, with more than half a million children dying every year due to severe infections. Recent publications in the New England Journal of Medicine showed a substantial reduction in deaths of Mexican children due to diarrheal disease after the introduction of Rotarix®, and in clinical trials in impoverished, high-mortality communities in Africa, the vaccine significantly reduced severe rotavirus disease in African infants. Because of the tremendous burden of disease in developing countries, the director of the US Centers for Disease Control and Prevention stressed that the known benefits of continued use of Rotarix® far outweigh a theoretical risk of harm and encouraged its continued use in countries where rotavirus burden is acute.

February 3, 2010 Rotavirus vaccines demonstrate impact through routine use and efficacy in the developing world New data published last week in the New England Journal of Medicine reveal the impact of rotavirus vaccines and their lifesaving potential for the developing world. Data from Mexico, which began immunizing children against rotavirus in 2006, illustrate the real-world impact of rotavirus vaccines when added to routine immunization programs. During the 2009 rotavirus season, diarrheal disease death rates dropped by more than 65 percent among children aged two years and younger. In addition, vaccination may also have protected unimmunized children in the same community by reducing their exposure to rotavirus. In South Africa and Malawi, a clinical trial in high-mortality, low-income settings showed that the vaccine significantly reduced severe rotavirus disease—by 61.2 percent—among African infants. Coordinated by PATH's Rotavirus Vaccine Trials Partnership and vaccine manufacturer GlaxoSmithKline, the study provided crucial data that was instrumental to informing the World Health Organization's recent recommendation that rotavirus vaccines be included in every country's immunization program. Data from a clinical trial of Merck Sharp & Dohme's rotavirus vaccine, RotaTeq®, (conducted in Bangladesh, Vietnam, Ghana, Kenya, and Mali) are expected later this year. Rotavirus vaccines can save lives when introduced in the high-burden countries where they are most needed. In the developing world, where rates of severe rotavirus disease are order of magnitudes higher than industrialized countries, rotavirus vaccines can have a major public health impact. In countries where rotavirus vaccines have already been introduced, progress is evident, and organizations such as the GAVI Alliance and WHO are working to make sure momentum is maintained and rotavirus vaccines soon reach all children who need them. Watch a new video from PATH to learn more about the progress and promise of rotavirus vaccines.

January 29, 2010 PATH’s Enhanced Diarrheal Disease Control Initiative is pleased to share with you a new video about the promise and potential of rotavirus vaccines: http://www.path.org/media/common-disease-promising-solution.php. We are thrilled to launch this video in the midst of several exciting developments this week. Here’s what’s causing the buzz:

  • To usher in the new year, Bono, lead singer of U2 and co-founder of the ONE Campaign, published an editorial in the New York Times that proposed "10 ideas that might make the next 10 years more interesting, healthy, or civil." Rotavirus vaccines make the list.
  • Yesterday (Thursday, January 28), the New England Journal of Medicine published two studies that provide ground-breaking data for accelerating the introduction of rotavirus vaccines. Click here to view PATH’s press release.
  • Today (Friday, January 29), at the World Economic Forum, Bill Gates announced that he would commit $10 billion over the next 10 years to help research, develop, and deliver vaccines to developing countries. The Gates Foundation cites PATH's Rotavirus Vaccine Program and the New England Journal of Medicine research on rotavirus vaccines as examples of the encouraging progress that inspired them to commit more resources to this endeavor.

These developments make the video all the more timely as an important resource to sustain momentum and get the vaccines to the children who need them most. We’d be grateful if you could assist us in our outreach by sharing the video as widely as possible with your colleagues, in your newsletter, and on your website. If you engage in social media outreach, we would also like to invite you to update your Facebook status with the video link and re-tweet some of the recent announcements we've been making on PATHtweets about rotavirus vaccines (http://twitter.com/PATHtweets).

December 3, 2009 Vaccine journal’s special edition chronicles a decade of rotavirus surveillance in Asia A new, special edition of the journal Vaccine broadens understanding of the tremendous burden of rotavirus disease in Asia. The Asian Rotavirus Surveillance Network, established in 1999, worked during the past decade to gather and disseminate rotavirus disease and strain burden data in 23 countries/regions, 11 of which are eligible for support from the GAVI Alliance. In addition to documenting severe rotavirus and resulting hospitalizations in countries throughout Asia—from Kyrgyzstan, Pakistan, and India to China, Vietnam, and the rest of the Pacific Rim region—the edition also covers the distribution of rotavirus genotypes across the region. Vaccine introduction efforts, including evidence of rotavirus vaccines’ impact through routine immunization programs, are also highlighted. A commentary article, “Rotavirus vaccines: The role of researchers in moving evidence to action,” explores how researchers apply their data to inform policymaking, encouraging them to build partnerships with organizations advocating for child survival and to explain the significance of their research findings to decision-makers. To request full text of specific articles, contact [email protected].

November 6, 2009 Journal of Infectious Diseases special edition highlights rotavirus burden data and role of vaccines to save lives This week, the Journal of Infectious Diseases published a special edition highlighting crucial data collected from rotavirus surveillance networks around the world. Expanded surveillance over the past several years has provided important insight on rotavirus disease burden and the potential impact of rotavirus vaccines. The tremendous burden documented by regional surveillance networks and presented here supports the need for widespread use of rotavirus vaccines, as recommended by the World Health Organization. Articles in the journal supplement also cover strain diversity, the need for continued disease surveillance, and vaccine cost-effectiveness.

Rotavirus: Every child should be vaccinated against diarrheal disease, WHO says
NY Times (6/8/09)

GAVI rotavirus vaccine introduction support expands to Nicaragua

The GAVI Alliance announced provision of support for rotavirus vaccine introduction to Nicaragua, which will allow the public sector to administer rotavirus vaccine to approximately 334,600 children. GAVI also announced support for pneumococcal vaccine introduction in Cameroon, Congo, and Yemen, while Armenia, Bhutan, Cambodia, Laos, and Sao Tome will receive support for introduction of a vaccine against Haemophilus influenzae type b (Hib). The decision follows an October board meeting at which GAVI committed to seek the US$3 billion necessary to continue existing programs and expand its portfolio of new vaccine support through 2015.

Expert group reviews data on rotavirus vaccine safety and efficacy in Africa

A recent meeting of the WHO’s Strategic Advisory Group of Experts (SAGE) featured an update on rotavirus disease and vaccines, including preliminary results of vaccine safety and efficacy trials in Africa. The trials, which PATH is sponsoring in collaboration with manufacturers GlaxoSmithKline (GSK) and Merck, will provide important data that speak to a previous SAGE recommendation that studies be conducted in these regions to inform a review of available data toward a global recommendation on the use of rotavirus vaccines. SAGE will review complete results in April 2009. A full report of the November 2008 meeting will soon be available on the SAGE website.

Successful trial results could lead to global recommendation on use of rotavirus vaccines

A recent summary of global rotavirus surveillance in the WHO’s Weekly Epidemiological Record emphasized the importance of data on epidemiology and burden of rotavirus disease for decision-makers considering vaccine introduction. Also essential for building an evidence base for review by country- and global-level officials are forthcoming data from clinical trials in Africa and Asia, which PATH is supporting in collaboration with the vaccine manufacturers. “If they demonstrate that the vaccine is efficacious,” states the article, “rotavirus vaccines might soon be recommended for global use by WHO.”

Data generated through surveillance networks in all regions of the world not only provide information on existing disease burden, but they also provide a baseline for evaluating the future impact of routine rotavirus vaccination. Click here to read the full article.

Enrollment underway for rotavirus vaccine effectiveness study in Bangladesh

In late September, investigators at the International Centre for Diarrheal Disease Research, Bangladesh, in partnership with RVP, GSK, the Government of Bangladesh, and UNICEF, initiated a phase IV cluster-randomized effectiveness study of RotarixTM. The study will evaluate the population effectiveness of RotarixTM and its impact on reducing rates of hospitalization for acute diarrhea due to rotavirus.

Study reveals RotarixTM is well tolerated among HIV-positive infants in South Africa

Results from a phase II study of the safety and immunogenicity of RotarixTM among HIV-infected infants in South Africa demonstrated that the vaccine was well tolerated and immunogenic when co-administered with routine childhood vaccines. Additionally, the rotavirus vaccine did not impact the clinical status of the HIV-positive infants. Presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, DC, in October, the data add to a growing evidence base on rotavirus vaccines’ performance in Africa.

Vietnam launches plans for renewed commitment to diarrheal disease control

PATH and the Vietnam Ministry of Health (MOH) formally initiated an effort to strategize for diarrheal disease control. A day-long workshop brought together officials from a range of MOH divisions, pediatricians from national and provincial hospitals, and representatives from PATH, UNICEF, and the Pasteur Institute. Presentations provided an overview of the diarrheal disease burden in Vietnam and information about interventions for diarrheal disease control, as well as a summary of an Enhanced Diarrheal Disease Control Initiative (EDD) project in Kenya.

Led by the Vice Minister of Health, the MOH and PATH will establish a technical working group to develop new national guidelines for diarrheal disease control, including the use of zinc treatment, low-osmolarity ORS, enteric vaccines, and the appropriate use of antibiotics. Development of the national strategy will be informed in part by an EDD demonstration project in the central province of Binh Dinh, where a community-based program will build awareness of interventions and train health care workers on proper management of diarrheal disease.

Vaccine slashes diarrheal illness in kids
Associated Press (10/25/08)

September 2008

WHO meeting on new vaccines yields recommendations on rotavirus vaccine introduction

The annual meeting on new and underutilized vaccines implementation (NUVI), convened by WHO, brings together global-, regional- and country-level stakeholders representing both the private and public sectors. The 2008 meeting, held June 23–25 in Geneva, featured a discussion on introduction issues related to rotavirus vaccines. The resulting recommendations include the following:

  • Partners should continue to advocate for political and financial commitment for new vaccine introduction.
  • Solid technical and cost-effectiveness data should be the basis for country-level decisions.
  • Countries should undertake effective planning prior to vaccine introduction, particularly with regard to training, cold chain capacity assessment, and vaccine supply requirements, given the markedly increased storage volumes required by the current presentations of rotavirus vaccine.

Further details on the 2008 NUVI meeting and the NUVI web page on rotavirus are available online.

Murdoch Children’s Research Institute collaborates with PATH to develop new rotavirus vaccine candidate

Under a new partnership, Murdoch Children’s Research Institute (MCRI) and PATH will support the further development of the MCRI rotavirus vaccine candidate, RV3. PATH will provide up to US$350,000 to assist MCRI in the production of clinical trial lots of RV3 under Good Manufacturing Practices (GMP) at Meridian Life Science in Memphis, Tennessee, in preparation for Phase 1 and 2 clinical trials to be conducted by MCRI.

The RV3 vaccine candidate was developed from a strain of rotavirus that was discovered in babies at a newborn nursery in Melbourne, Australia. Babies who were naturally infected with the RV3 strain had no symptoms and were protected from contracting rotavirus disease in the first three years of life.

Enhanced diarrheal disease control efforts expand to Asia

While studies to determine the safety and efficacy of rotavirus vaccines in Asia are ongoing, PATH is helping to raise awareness in the region, placing rotavirus in the context of broad diarrheal disease control planning. A new collaboration with the Ministry of Health (MOH) in Indonesia’s South Sulawesi province is educating health workers about diarrheal disease control interventions and distributing updated standards of practice. Future activities will look to expanding use of these standards to improve clinical case management nationwide.

In Vietnam, PATH is collaborating with the MOH and other in-country partners to evaluate the evidence for and feasibility of rotavirus vaccine uptake, along with the potential for future enteric vaccines. A pilot project in Binh Dinh province will scale up use of diarrheal disease treatment interventions, including zinc and low-osmolarity oral rehydration solution, and results will inform national planning.

Rotavirus Surveillance News summarizes ongoing vaccine effectiveness studies

The latest issue of Rotavirus Surveillance News provides an update on vaccine effectiveness studies in Latin America. The Pan American Health Organization, the US Centers for Disease Control and Prevention, and the Rotavirus Vaccine Program (RVP) are collaborating with the MOH in Nicaragua on a case control study to evaluate the effectiveness of RotaTeq®, manufactured by Merck & Co., Inc. These partners also are working with the MOH in El Salvador on a similar study of Rotarix®, manufactured by GlaxoSmithKline. Both studies were initiated in 2007 and are ongoing. Further details are available in the July 2008 surveillance newsletter.

In other rotavirus surveillance news, a recent article in Vaccine summarizes activities of the Asian Rotavirus Surveillance Network, including measurement of disease burden in GAVI-eligible countries and economic evaluations of the cost-effectiveness of rotavirus vaccine introduction.

US immunization recommendations updated to include Rotarix® vaccine

Following FDA approval of the Rotarix® vaccine manufactured by GlaxoSmithKline, the US Advisory Committee on Immunization Practices updated its recommendations on rotavirus vaccination to include information on administering the newly licensed vaccine. Data on both Rotarix® and Merck’s RotaTeq® presented to the ACIP during its June 2008 meeting are available online.

Survey highlights need to elevate priority of diarrheal disease

A recent PATH research report shows that global health policymakers, donors, and scientists are concerned that diarrheal disease does not receive enough attention among global health priorities. The research, conducted by FSG Social Impact Advisers, included interviews and surveys of 100 international stakeholders to gain insight into the global policy and funding environment surrounding diarrheal disease. Respondents expressed great interest in efforts that promote an integrated approach to diarrheal disease control, and they identified water and sanitation, oral rehydration solution/therapy, breastfeeding, and vaccines as the key elements that should be included in a “package” of interventions.

Improved access to rotavirus resources on the web

PATH’s online rotavirus resources were recently enhanced with the redesign of the Vaccine Resource Library (VRL) and updates to the RVP program website.

Continuing to offer high-quality, scientifically accurate documents and links, the new VRL is easier to navigate, with a web-based database that provides several ways to access content. The VRL is geared for health professionals in the developing and industrialized worlds, as well as journalists, policymakers, community leaders, parents, and anyone else interested in vaccine-related resources.

The RVP website now offers updates on strategic programmatic objectives to address country needs, convene key partners, and conduct rigorous science. An interactive timeline also depicts the many advancements in rotavirus surveillance and control, achieved by several committed partners in just a few short years.

Editorial highlights health-environment connection for diarrheal disease control in Africa

A recent editorial from the director of PATH’s Enteric Vaccine Initiative emphasized the potential of diarrheal disease control in addressing Millennium Development Goals on child health and environmental sustainability. Marking the close of the First Inter-Ministerial Conference on Health and the Environment in Africa, the article calls for action in addressing “one of Africa’s great, but ignored, health crises.”

Mauritius: "Increasing the population's health increases its wealth"
AllAfrica.com (7/23/08)

June 2008

Rotavirus symposium presents scientific developments with public health perspective

The 8th International Rotavirus Symposium brought together country leaders and scientific experts to discuss progress and remaining challenges in making rotavirus vaccines accessible to children around the world. The event, convened by the Albert B. Sabin Vaccine Institute, the Fogarty International Center, the Norwegian Institute of Public Health, the US Centers for Disease Control and Prevention (CDC), and PATH, welcomed more than 400 participants from 67 countries—the symposium’s highest-ever participation. Presentations provided scientific and programmatic updates on rotavirus disease surveillance, clinical trials to address vaccine safety and efficacy in developing countries, country experiences with vaccine introduction, development of candidate rotavirus vaccines, and evidence to inform country decision-making. Presentations will soon be available on the symposium’s website.

Preliminary data reveal high efficacy of rotavirus vaccine in South Africa

Interim results from a clinical trial of rotavirus vaccine in South Africa and Malawi, presented for the first time at the International Rotavirus Symposium, offer a very promising signal about the potential of rotavirus vaccines in the world’s poorest countries. Principal investigator Dr. Shabir Mahdi of Dr. George Mukhari Hospital presented the data, which reveal that Rotarix® manufactured by GlaxoSmithKline was 83 percent efficacious in preventing severe rotavirus gastroenteritis among infants in impoverished populations of South Africa. The full results, which will include data from children in Malawi, will be available in early 2009.

While rotavirus vaccines are currently licensed and used in several countries, the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) recommended clinical trials in Asia and Africa where rotavirus disease burden is very high and where oral vaccines have the potential to perform differently. In addition to the Rotarix® trial, PATH is conducting trials of Rotateq® in impoverished populations of five additional countries in Africa and Asia in partnership with manufacturer Merck & Co., Inc, with results expected in late 2009. SAGE will review the evidence from these trials to inform its recommendation on the global use of rotavirus vaccines.

Lessons learned in Latin America will inform future rotavirus vaccine introduction

Rotavirus vaccine introduction in several countries of Latin America has yielded important lessons learned, as presented at the symposium by Dr. Lucia Helena de Oliviera, regional advisor for new vaccines with the Pan American Health Organization (PAHO). In particular, countries need to address the issue of cold chain storage capacity with new rotavirus vaccines; evaluate systems to monitor immunization coverage; train and supervise vaccine providers; and conduct rotavirus strain surveillance. The experiences of early adopters in considering and implementing these activities will be important for facilitating rotavirus vaccine introduction in other countries, as well as ensuring sustainable programs throughout the region and the world. Dr. Oliviera and collegues further expand upon these issues and experiences (summary only without subscription) in a study recently published in Expert Review of Vaccines.

Study shows rotavirus vaccines are cost-effective in GAVI-eligible countries

Introducing rotavirus vaccines in developing countries not only has the potential to save millions of lives, but the intervention is also cost-effective. At the recent rotavirus symposium, PATH senior health economist and policy officer Dr. Deborah Atherly reviewed an analysis of the cost-effectiveness and impact of rotavirus vaccines in GAVI-eligible countries. The analysis combined cost-effectiveness results with estimates of vaccine adoption over time. Results indicate that rotavirus vaccination is cost-effective in all GAVI-eligible countries and could avert the deaths of 225,000 children per year at peak adoption and 2.5 million deaths between 2008 and 2025. In addition, cost-effectiveness ratios improve and vaccine impact increases substantially over time, primarily due to adoption in higher-burden countries and estimated price decline.

Dr. Atherly noted market-related issues that must be addressed to achieve these significant outcomes. These include improving demand forecasting to assure sustainable supply, understanding and closely monitoring the supplier landscape to ensure that supply matches demand, and continuing to address vaccine affordability so that countries can support sustainable immunization programs.

Partners undertake broad range of activities to address rotavirus research priorities

While progress continues with the currently available rotavirus vaccines, significant efforts are underway to lay a foundation for future candidates. Dr. Duncan Steele, PATH’s senior advisor on diarrheal disease, discussed research priorities—as recommended by SAGE and the WHO Global Advisory Committee on Vaccine Safety—along with the activities PATH and partners are currently conducting to address them:

  • Several countries have initiated post-marketing surveillance to assess vaccine safety with respect to intussusception and other potential rare adverse events;
  • PATH is working closely with emerging manufacturers in India and China to develop the next generation of rotavirus vaccines, providing clinical expertise and an “enabling platform” of technology support to expand the manufacturers’ capacity; and
  • Surveillance activities continue to monitor strain diversity and genotypes in various global settings.

Partner profile: Curatio International Foundation

Manana Khotchava, a pediatrician in Georgia, shakes her head sadly when asked about the problem of diarrheal disease in her country. “This is a real issue,” she says. “Many children are suffering, but it is a struggle to get our policymakers to take action because we don’t yet have the information to convince them.”

Underreporting and unconfirmed diagnoses of diarrheal disease are common in Georgia, Dr. Khotchava explains. While severe cases are reported as they come across with the health care system, she says, those are just “the tip of the iceberg.”

In Georgia, as in other former Soviet countries, the transition to a free-market economy spurred semi-privatization of health care. For many Georgians, though, the introduction of private health care has meant skyrocketing costs, hindering some from seeking care for their children for common illnesses like diarrhea. At the same time, low pay for providers has contributed to underreporting of diarrheal disease.

Surveillance and information systems have been strengthened during recent years, explains Ivdity Chikovani, a program manager at the Curatio International Foundation (CIF), a nongovernmental organization created in 1994 to help reform health systems in transition economies. “However, they are far from perfect,” she explains, “and it is important to work on multiple fronts to strengthen policy, information systems, and laboratory procedures.”

In January 2008, CIF partnered with PATH to host a regional conference in Tbilisi, Georgia. Bringing together academics, health care workers, and policymakers, the workshop generated significant interest in rotavirus vaccines and broader diarrheal disease control measures. CIF and PATH continue to work with Georgian academics, health care providers, and the Ministry of Health to address barriers to diarrheal disease control.

The partnership has resulted in a draft nationwide plan on prevention and treatment interventions, and has facilitated new diarrheal disease management guidelines. The plan aims to facilitate education of clinicians and medical students, assist with the introduction of the new ORS and zinc preparations on the local pharmaceutical market, create standard diagnostic laboratory procedures to improve the disease surveillance system, implement a system for measuring intervention impact, and revise the national multi-year immunization plan to set the stage for introduction of the rotavirus vaccine in the coming years.

CIF’s history of strengthening health systems in the region, as well as increasing interest in diarrheal disease control, gives Chikovani and her colleagues hope for progress and scale-up. “We really hope the work we are doing in Georgia will be able to be applied to other countries in the region as well.”

World’s leading health experts urge countries to use newly released data to prevent the death of millions of children due to rotavirus
Yahoo News (6/4/08)

May 2008

PATH implements diarrheal disease control initiative in Kenya

PATH recently launched a pilot program in Kenya’s Western Province aimed at building awareness for new diarrheal disease control interventions. Interactions with provincial and district public health officials informed the project’s planned activities, which include workshops with parents and providers over the coming weeks to assess current practices and knowledge gaps around diarrheal disease control. Building on the needs identified through these workshops, PATH will then begin training providers and educating community members on diarrheal disease control interventions, including rotavirus vaccines, zinc treatment, and low-osmolarity oral rehydration solution, while also generating greater support for hand washing and exclusive breastfeeding. Results from the project will be help develop Kenya’s National Plan for Diarrheal Disease Control, and activities were recently endorsed by Kenya’s Child Health Inter-agency Coordinating Committee (ICC). The ICC has appointed a technical advisory group to monitor progress and make recommendations.

GAVI Alliance conference notes achievements and barriers in global childhood immunization

A recent symposium in Barcelona highlighted the impact of immunization on saving children’s lives in the world’s poorest countries. Policymakers, researchers, and funders came together at the event, “Advancing Immunization in Developing Countries: New Horizons in Children’s Health,” to review achievements, explore options for overcoming barriers, and call for continued support for immunization in developing countries. According to WHO estimates, GAVI programs have saved the lives of nearly 3 million children since 2000. Among the achievements noted was the accelerated availability of new vaccines, including rotavirus, in developing countries that carry the greatest burden.

The event marked three years since stakeholders signed the Barcelona Declaration toward increased investment in current and future vaccines. Both the Government of Spain and La Caixa, the country’s largest corporate foundation—which cosponsored the event along with the Barcelona Centre for International Health Research—have made considerable contributions to global childhood immunization programs, particularly to GAVI’s International Finance Facility for Immunization.

Read the GAVI press release.

Merck updates RotaTeq® label information

Merck & Co., Inc., updated the post-marketing section of its US Product Circular for RotaTeq® to indicate the occurrence of death following intussception (a rare, life-threatening blockage of the intestine). The US Food and Drug Administration (FDA) and Merck agreed to update the label to stimulate early reporting of potential adverse events and to note the potential severity of intussusception. A report to the Vaccine Adverse Events Reporting System (VAERS) does not mean that a causal relationship between an event and vaccination has been established—just that the event occurred after vaccination.

Prior to the FDA’s approval of RotaTeq® in 2006, a clinical trial with more than 70,000 subjects found that the vaccine was not associated with an increased risk of intussusception, or other serious adverse events, when compared to placebo. Data presented to the CDC’s Advisory Committee on Immunization Practices following the first year of RotaTeq® use in the US demonstrated that the rate of intussusception in infants receiving the vaccine was not greater than expected by chance alone, indicating that the vaccine does not pose an elevated risk for intussusception (specific data and limitations are presented in the slide set entitled “RotaTeq® vaccine reports to VAERS.”) In the US, the expected background rate of naturally-occurring intussusception in unvaccinated infants of the same age is 18 to 43 cases per 100,000, according to the US Centers for Disease Control and Prevention (CDC).

Because of a suspected association between intussusception and an earlier rotavirus vaccine (RotaShield®), the CDC and FDA are closely monitoring the safety of new rotavirus vaccines. PATH is supporting a collaboration between the CDC, FDA, and the Pan American Health Organization to establish active surveillance of intussusception among vaccinated and unvaccinated children in two Latin American countries that have introduced rotavirus vaccines.

The 8th International Rotavirus Symposium

Registration is ongoing for the 8th International Rotavirus Symposium, June 3 to 4, 2008, in Istanbul, Turkey. This event will bring together public health professionals, ministry officials, and representatives from industry and the donor community to provide updates on clinical trials of new rotavirus vaccines, early post-marketing data on vaccine impact and safety, issues in vaccine policy and introduction, and other relevant topics. Simultaneous English/Russian translation will be provided.

Registration details and other relevant information, including a preliminary program, are available at the conference website.

Award recognizes contributions of leader in global rotavirus efforts

Rotavirus expert Dr. Roger Glass was honored at this week’s Annual Conference on Vaccine Research, where he received the Charles Merieux Award for his extensive work to bring rotavirus vaccines to the developing world. Currently serving as director of the US National Institutes of Health Fogarty International Center, Dr. Glass established the Viral Gastroenteritis Unit of the US CDC, which has led national and global rotavirus efforts, including surveillance and vaccine introduction, for several years.

Update on surveillance activities in Africa

The latest issue of the African Rotavirus Surveillance Network newsletter provides an update on surveillance activities in participating countries and summarizes recent training activities.

Open positions with PATH immunization programs

At PATH we believe that every child deserves a healthy start in life. PATH's Immunization Solutions Strategic Program supports the integration of vaccines for disease control in developing countries by determining disease burden; conducting clinical trials; establishing the health economics of vaccine use; and advocating for appropriate policies. In addition, we implement activities that improve the accessibility of high-quality immunization services. If you'd like to help lead our growing efforts, consider applying for one of these positions:

  • Senior Scientific Advisor (position #3274)
  • Program Officer (postion #3258)
  • AVI Director (position #3252)

If you are interested in applying for any of these positions with PATH's Immunizations Solutions Strategic Program—visit PATH's employment page to see the relevant job announcement and application instructions. Help us spread the word! Forward this e-mail or let us know of people we should reach out to.

Letter to the editor: Diarrheal disease
New York Times (5/26/08)

Rotavirus vaccine shows promise in Latin American infants
Medical News Today (4/4/08)

Rotarix® rotavirus vaccine receives US FDA approval
RotaFlash (4/4/08)

February 2008

Workshop informs diarrheal disease control planning in Eastern Europe

Child health experts and immunization program managers from Eastern Europe and Central Asia discussed new opportunities for controlling diarrheal disease at a two-day workshop in Tbilisi, Georgia, sponsored by PATH in partnership with the Republic of Georgia’s Ministry of Labor, Health, and Social Affairs and the Curatio International Foundation. Health officials from Kyrgyzstan, Ukraine, Uzbekistan, Armenia, Azerbaijan, Moldova, Tajikistan, and Georgia discussed the burden of diarrheal disease in their own countries and summarized existing control strategies. Representatives from UNICEF, the World Health Organization (WHO), the GAVI Alliance, and PATH presented regional morbidity and mortality data, along with evidence on zinc treatment, low-osmolarity oral rehydration solution, and rotavirus vaccines as critical tools for an integrated approach to enhance diarrheal disease control.

PATH is now working with the Georgian MOH to develop a national diarrheal disease control plan, and the workshop opened the door to future collaborations with other countries interested in developing or updating control plans, introducing rotavirus vaccines, or accelerating uptake of other interventions.

Advisory panel recommends Rotarix® licensure in US

The US Advisory Committee on Vaccines and Related Biological Products issued a positive recommendation this week that the US Food and Drug Administration (FDA) approve GlaxoSmithKline’s application for licensure of Rotarix® for use in the US.

The panel’s recommendation followed a review of data from clinical trials on the safety and efficacy of Rotarix®. The FDA should make its ultimate decision on Rotarix® licensure in the US within the coming weeks. The other currently available rotavirus vaccine, RotaTeq® manufactured by Merck & Co., Inc., received FDA approval in 2006.

US government acknowledges Merck contributions to public health in Nicaragua

In recognition of an innovative partnership with the Nicaraguan MOH to introduce RotaTeq®, the US State Department selected Merck & Co., Inc., as a finalist for its 2007 Award for Corporate Excellence (ACE). Representatives from project partners including the Pan American Health Organization, NicaSalud, UNICEF, the Nicaraguan Pediatric Society, and PATH attended a ceremony to acknowledge the nomination, held at the US embassy in Managua on February 8, 2008.

The vaccine’s launch on October 27, 2006, made Nicaragua the first GAVI-eligible country to introduce rotavirus vaccine and marked the first time a vaccine was introduced in the public sector of a developing country during the same year it was introduced in the industrialized world. Historically, it has taken up to 15 years for new vaccines to reach the world’s poorest countries.

Announcing the 8th International Rotavirus Symposium; Call for abstracts

The 8th International Rotavirus Symposium will bring together public health professionals, ministry officials, and representatives from industry and the donor community to provide updates on clinical trials of new rotavirus vaccines, early post-marketing data on vaccine impact and safety, issues in vaccine policy and introduction, and other relevant topics. The symposium will be held June 3 to 4, 2008, at the Sheraton Istanbul Maslak Hotel in Istanbul, Turkey. Registration details and other relevant information, including a working agenda and session abstracts, will soon be posted at http://www.rotavirus2008.com (under construction).

The Scientific Organizing Committee is now accepting abstracts for posters relevant to rotavirus, rotavirus vaccines, and rotavirus vaccine introduction. Click here for guidelines. Submissions should be sent to mailto:[email protected].

Moldova joins European Rotavirus Surveillance Network

Representatives from PATH and the WHO Europe regional office recently visited Moldova to establish rotavirus surveillance and generate data for officials to consider regarding a potential application to GAVI for vaccine introduction support. The Children’s Infectious Disease Hospital in Chisinau will establish sentinel surveillance, with diagnostic support from the national polio laboratory. With the initiation of these activities, Moldova became the seventh country in the European Rotavirus Surveillance Network, with activities supported by the US Centers for Disease Control and funding provided by the PATH Rotavirus Vaccine Program. Click here to read more about the European Rotavirus Surveillance Network.

New staff join PATH to advance control of diarrheal disease and cervical cancer

Two key staff members recently joined PATH to bring their experience to new initiatives. Dr. Duncan Steele joined PATH as a technical advisor on projects to develop vaccines against enteric diseases and rotavirus. Most recently a scientist with the WHO Department of Immunization, Vaccines, and Biologicals, where he served as primary liaison and advisor for PATH’s Rotavirus Vaccine Program, Dr. Steele has worked in various fields of diarrheal disease control since the early 1980s.

Dr. Juan José Amador joined PATH’s Nicaragua office as Director of Technology and Health Systems for the START-UP project, aimed at creating sustainable cervical cancer treatment programs in low-resource countries. Prior to joining PATH, Dr. Amador worked for the Nicaraguan MOH as National Director of Epidemiology. His leadership was instrumental in reinvigorating diarrheal disease control strategies, including the successful introduction of RotaTeq® in Nicaragua in October 2006.

PATH resources summarize diarrheal disease control interventions

A new set of fact sheets from PATH aims to raise awareness about new and established tools to fight rotavirus and other causes of diarrheal disease in the world's poorest countries. Click the title below to access a fact sheet on each intervention:

Partner Profile: Noguchi Memorial Institute for Medical Research, Ghana

An avid investigator of rotavirus for more than 25 years, Dr. George Armah hopes that his own drive is reflected in the momentum of future policy decisions on rotavirus vaccines in Africa. Such policies will be boosted by data from critical studies including the one he directs on behalf of PATH and Merck to evaluate RotaTeq® in Ghana. Above all, he would like to see his team’s work ease the burden of parents traveling miles on bicycle or by foot to seek treatment for their ailing children. Prevention with rotavirus vaccines as could be an important solution.

Dr. Armah’s initial work with rotaviruses focused on strain identification and epidemiology, eventually leading to his post as co-investigator and researcher on immunogenicity studies of rotavirus vaccines manufactured by Wyeth and GSK. In mid-2006, PATH partnered with the Noguchi Memorial Institute for Medical Research, University of Ghana, where Dr. Armah leads a team of researchers at the Navrongo Health Research Centre to evaluate the safety and efficacy of RotaTeq® among infants. The partnership allows the site to build capacity in human resources and research skills, and in turn the investigators are contributing crucial data to not only inform the use of rotavirus vaccines in Ghana but also to benefit the global public health community. The trial’s enrollment is now complete, and the site is actively participating in subject follow-up visits. Dr. Armah expects study results by the end of 2009.

New resource to assist countries applying for GAVI support of rotavirus vaccines

Developed by PATH in partnership with GAVI and WHO, Introduction of rotavirus vaccine with support from the GAVI Alliance: Information to assist the national decision-making and application process summarizes scientific evidence and operational guidelines for introducing rotavirus vaccines. As a supplement to GAVI’s detailed guidelines, the document aims to support decision-making by GAVI-eligible countries in the WHO European region and provides information on the burden of rotavirus disease; efficacy, safety, and cost-effectiveness of available rotavirus vaccines; eligibility criteria; application procedures; co-financing requirements; and health system considerations.

The information pack is also available in Russian, and updates will be posted on GAVI’s website in accordance with new information and GAVI decisions on eligibility in other WHO regions.

Glaxo rotavirus vaccine appears safe -- US FDA panel
Reuters (2/20/08)

December 2007

GAVI Alliance approves rotavirus vaccine applications in Latin America

Following up on its November 2006 pledge to subsidize rotavirus vaccines in developing countries, the GAVI Alliance recently approved applications from Bolivia, Guyana, and Honduras. Introduction in these countries as early as next year brings to fruition the primary goal of GAVI’s Accelerated Development and Introduction Plans—PATH’s Rotavirus Vaccine Program and the PneumoADIP housed at Johns Hopkins University—toward dramatically reducing the timeline for access to new vaccines in the poorest parts of the world. Historically, it has taken more than 15 years for new vaccines to reach the developing world. In 2006, that timeline was significantly reduced, with rotavirus vaccines introduced in the US and several countries of the European Union, as well as in Nicaragua—marking the first time ever that a vaccine was introduced in a GAVI-eligible country in the same year that it was approved in the industrialized world. Introduction in Bolivia, Guyana, and Honduras will bolster this important achievement.

GAVI also announced support for pneumococcal vaccine introduction in Nicaragua, Ghana, and Honduras, in addition to funding for a significant increase in countries introducing Hib vaccine. Click here to learn more.

All sites enrolling participants for PATH/Merck collaboration in Asia and Africa

In late September, a site in Nha Trang, Vietnam, began enrolling infants for the clinical trial of RotaTeq®, a collaboration between PATH and Merck & Co., Inc. All sites, which also include facilities in Mali, Kenya, Ghana, and Bangladesh have now completed or will complete enrollment during the next couple of months, with follow-up activities ongoing.

PATH is working in partnership with both Merck and GSK to determine the safety and efficacy of new rotavirus vaccines in Africa and Asia, as recommended by the WHO Strategic Advisory Group of Experts.

Long-term efficacy data on rotavirus vaccines show continued protection

Efficacy profiles of the rotavirus vaccines produced by Merck and GSK were recently boosted by additional data. New RotaTeq® prescribing information reveals that the vaccine reduced hospitalizations and emergency room (ER) visits by 100 percent for serotype G9P1A(8). These data are based on healthcare usage by participants in the manufacturer’s vaccine previously published Phase 3 safety and efficacy trial.

An article in The Lancet presents data that show high efficacy for GSK’s Rotarix® administered with routine vaccines. Over two seasons, Rotarix® demonstrated 90 percent efficacy against severe rotavirus among European children and 79 percent against all rotavirus infections. This issue of The Lancet also included a commentary on the relevance of these data for rotavirus vaccine introduction in the developing world and the need for specific studies to determine efficacy among infants in Africa and Asia. Please note that these articles are available to the public, but individual registration on The Lancet website is required.

Rotavirus Surveillance News: African Regional Network

The latest issue of Rotavirus Surveillance News provides an update on active surveillance activities in seven African countries. Data collected through the network reveal important information that will be relevant for decision-making on rotavirus vaccine introduction. Two regional reference laboratories (based in Ghana and South Africa) support the network and provide routine training.

WHO publishes Global Framework for Immunization Monitoring and Surveillance

WHO recently released a new comprehensive approach to tackle challenges in immunization monitoring and disease surveillance. The Global Framework for Immunization Monitoring and Surveillance was developed by WHO and the US CDC. It responds to the need for timely and valid epidemiological and program information that is crucial in measuring progress towards immunization goals and controlling vaccine-preventable diseases, including rotavirus. An editorial in the December 2007 issue of the WHO Bulletin outlines the resources and guidance provided through the document, along with the rationale for its development.

updated: 23 August, 2019