Milestones :: Perspectives

Milestones :: Perspectives

Editor’s Note:
We urge readers to invest the time necessary to read and absorb the “Five Most Important Points” below excerpted from this first report of the Transition Independent Monitoring Board (TIMB). We are reflecting on their strategic impact to the poliovirus eradication effort, early planning for GVAP 2.0, and, indeed, the “immunization enterprise” overall.

THE END OF THE BEGINNING – First Report of the Transition Independent Monitoring Board of the Polio Programme
July 2017 :: 35 pages
This report
The Transition Independent Monitoring Board (TIMB) was created by the Global Polio Eradication Programme (GPEI) to monitor and guide the process of polio transition planning. This is our first report. It provides an initial analysis of the priorities, plans, risks and opportunities as the eradication of polio appears to be drawing closer. In this first report, we have concluded by identifying areas of further work. Our subsequent reports will make recommendations for action.

F I V E  M O S T  I M P O R TA N T  P O I N T S
:: On average, 25% to 50% of staff funded through the Global Polio Eradication Initiative (GPEI) spend time on non-polio activities such as routine immunisation, broader disease surveillance, laboratory support, and responding to public health emergencies; some countries’ health systems have been heavily dependent on polio funding for decades; 95% of the polio asset footprint is concentrated in 16 countries that are the most vulnerable to withdrawal of funding; many of the same countries face simultaneous withdrawal of funding from Gavi and some other sources.

:: If polio eradication succeeds but poorer countries’ public health services collapse in the initiative’s wake, it would be a major failure of global governance and stewardship. The risks to global health and to vulnerable populations are high if the polio transition process is mismanaged. They include: disruption of the path to eradication so that polio resurges; failure to secure and sustain staff, infrastructure and expertise necessary to detect, prevent and control other communicable diseases; direct threats to global biosecurity; rises in death rates from vaccine preventable diseases; humanitarian crises in fragile states; lost opportunities to develop health systems; a drop in resources to respond to public health crises.

:: The transition planning process initiated by the Global Polio Eradication Initiative (GPEI) is predicated on four assumptions: firstly, that to the degree possible, countries will absorb the costs of sustaining polio assets within their public health systems; secondly, that countries will prepare national plans that map out the role polio assets play in their health systems and the deficits that will be created when the GPEI closes; thirdly, that the national plans will align with the targets laid out in the Global Vaccine Action Plan (GVAP) approved and endorsed by all WHO member states; fourthly, that by-and-large donors will be prepared to fill the gap.

:: The GPEI is not a donor. It has been a vehicle for receipt of donations and targeting expenditure for 30 years. As polio eradication nears, the GPEI’s legitimacy to mobilise and oversee resources for the resulting gaps in public health provision is fading. It will not be in a position to receive, coordinate, or allocate donor funding for such purposes; soon it will not exist. Once at the end of polio eradication, funding gaps for routine immunisation and other services will be recurrent and permanent; there will be less donor tolerance towards those countries that they feel should be providing their own resources for non-polio public health services.

:: Beyond the world of polio leaders, academics, donors, and enthusiasts, there is little awareness or understanding of the enormity, complexity, and urgency of the action needed to deal effectively winding down of polio funding begun in 2017; nor is there enough appreciation that the poliovirus will not feel the need to comply with an orderly series of planned measures that will allow itself to be eradicated; polio eradication is progressing alongside polio transition planning and if the latter speeds too far ahead, there is a huge risk that resources will not be available to respond to polio and other disease outbreaks.
Experimental HIV vaccine regimen is well-tolerated, elicits immune responses
NIH   Monday, July 24, 2017
Results from early-stage NIH-funded trial support further development of candidate vaccines.
Results from an early-stage clinical trial called APPROACH show that an investigational HIV vaccine regimen was well-tolerated and generated immune responses against HIV in healthy adults. The APPROACH findings, as well as results expected in late 2017 from another early-stage clinical trial called TRAVERSE, will form the basis of the decision whether to move forward with a larger trial in southern Africa to evaluate vaccine safety and efficacy among women at risk of acquiring HIV.

The APPROACH results will be presented July 24 at the 9th International AIDS Society Conference on HIV Science in Paris.

The experimental vaccine regimens evaluated in APPROACH are based on “mosaic” vaccines designed to induce immunological responses against a wide variety of HIV subtypes responsible for HIV infections globally. Different HIV subtypes, or clades, predominate in various geographic regions around the world. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, funded pre-clinical development of these vaccines. Together with other partners, NIAID supported the APPROACH trial, which is sponsored by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The manufacture and clinical development of the mosaic vaccines are led by Janssen.

“A safe and effective HIV vaccine would be a powerful tool to reduce new HIV infections worldwide and help bring about a durable end to the HIV/AIDS pandemic,” said NIAID Director Anthony S. Fauci, M.D. “By exploring multiple promising avenues of vaccine development research, we expand our opportunities to achieve these goals.”…

Johnson & Johnson Announces Encouraging First-in-Human Clinical Data for Investigational HIV Preventive Vaccine
…In Phase 1/2a APPROACH study, HIV-1 antibody response observed in all healthy volunteers
…Mosaic-based vaccine regimen is designed to elicit an immune response against a wide variety of HIV subtypes prevalent worldwide
…Positive clinical and preclinical results inform selection of lead mosaic HIV vaccine regimen for further evaluation in Phase 2b proof-of-concept study
July 24, 2017
PARIS, France–(BUSINESS WIRE)–Johnson & Johnson today announced encouraging first-in-human clinical data for an investigational HIV-1 vaccine regimen in development at its Janssen Pharmaceutical Companies. In an oral presentation of the early stage Phase 1/2a APPROACH study at the 9th IAS Conference on HIV Science (IAS 2017), the “mosaic”-based vaccine regimen from Janssen Vaccines & Prevention B.V. (Janssen) appeared to be well-tolerated and elicited HIV-1 antibody responses in 100% of healthy volunteers (n=393).

“Finding a preventive vaccine has proven to be one of the biggest scientific challenges in the 35-year quest to end the HIV pandemic. A successful preventive vaccine for HIV will need to provide broad protection against a wide range of viral strains,” said Professor Dan Barouch, Harvard Medical School, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a key collaborator for APPROACH. “These promising, early-stage results suggest that these vaccines utilizing mosaic immunogens should be evaluated further for their potential ability to achieve this historic goal.”

Significant progress has been made in the global battle against HIV/AIDS, including the development of critical antiretroviral treatments and HIV prevention tools, yet the disease remains one of the greatest global health threats of our time. An estimated 37 million people are currently living with HIV-1 globally, and nearly 2 million people become newly infected each year. An effective HIV vaccine is elusive due to the unique properties of the virus – including its genetic diversity and ability to mutate rapidly.

Mosaic-based vaccines contain immunogens created using genes from different HIV subtypes responsible for HIV-1 infections worldwide. These immunogens are delivered through viral vectors, including Janssen’s AdVac® technology based on adenovirus serotype 26 (Ad26). The viral vectors are combined with other components such as soluble proteins to form mosaic-based prime-boost vaccine regimens that first prime and then boost the immune system, with the aim of producing stronger and longer-lasting immunity to HIV.

Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson said, “In recent years, a new optimism has emerged that we will find an effective HIV vaccine in our lifetime. The results from today’s study add to that belief and we look forward to advancing to the next stage of clinical development as quickly as possible.”

In pre-clinical studies, regimens incorporating mosaic vaccines demonstrated protection against infection with an HIV-like virus. The most effective prime-boost regimen in these studies reduced the per-exposure risk of infection by 94 percent and resulted in 66 percent complete protection after six exposures.

Based on immunologic responses observed in APPROACH, as well as protection observed in pre-clinical studies, a lead HIV-1 vaccine regimen comprising Janssen’s Ad26 mosaic candidate and the Clade C gp140 soluble protein has been selected as the basis for further evaluation in a potential Phase 2b proof-of-concept efficacy study. Should this study move forward, Janssen and its global partners anticipate initiating this investigation in southern African countries in late 2017 or early 2018…
Statement by UNICEF Executive Director, Anthony Lake, WFP Executive Director, David Beasley and WHO Director-General, Dr Tedros Adhanom Ghebreyesus, following their joint visit to Yemen
Joint WHO/UNICEF/WFP statement
26 JULY 2017 | ADEN/SANA’A – “As the heads of three United Nations agencies – UNICEF, the World Food Programme (WFP) and WHO – we have travelled together to Yemen to see for ourselves the scale of this humanitarian crisis and to step up our combined efforts to help the people of Yemen.

“This is the world’s worst cholera outbreak in the midst of the world’s largest humanitarian crisis. In the last 3 months alone, 400 000 cases of suspected cholera and nearly 1900 associated deaths have been recorded. Vital health, water and sanitation facilities have been crippled by more than 2 years of hostilities, and created the ideal conditions for diseases to spread.

“The country is on the brink of famine, with over 60 per cent of the population not knowing where their next meal will come from. Nearly 2 milllion Yemeni children are acutely malnourished. Malnutrition makes them more susceptible to cholera; diseases create more malnutrition. A vicious combination…

“Amid this chaos, some 16 000 community volunteers go house to house, providing families with information on how to protect themselves from diarrhea and cholera. Doctors, nurses and other essential health staff are working around the clock to save lives.

“More than 30 000 health workers haven’t been paid their salaries in more than 10 months, but many still report for duty. We have asked the Yemeni authorities to pay these health workers urgently because, without them, we fear that people who would otherwise have survived may die. As for our agencies, we will do our best to support these extremely dedicated health workers with incentives and stipends.

“We also saw the vital work being done by local authorities and NGOs, supported by international humanitarian agencies, including our own. We have set up more than 1000 diarrhoea treatment centres and oral rehydration corners. The delivery of food supplements, intravenous fluids and other medical supplies, including ambulances, is ongoing, as is the rebuilding of critical infrastructure – the rehabilitation of hospitals, district health centres and the water and sanitation network. We are working with the World Bank in an innovative partnership that responds to needs on the ground and helps maintain the local health institutions.

“But there is hope. More than 99 per cent of people who are sick with suspected cholera and who can access health services are now surviving. And the total number of children who will be afflicted with severe acute malnutrition this year is estimated at 385,000.

“However, the situation remains dire. Thousands are falling sick every day. Sustained efforts are required to stop the spread of disease. Nearly 80 percent of Yemen’s children need immediate humanitarian assistance.

“When we met with Yemeni leaders — in Aden and in Sana’a — we called on them to give humanitarian workers access to areas affected by fighting. And we urged them – more than anything – to find a peaceful political solution to the conflict.

“The Yemeni crisis requires an unprecedented response. Our 3 agencies have teamed up with the Yemeni authorities and other partners to coordinate our activities in new ways of working to save lives and to prepare for future emergencies.

“We now call on the international community to redouble its support for the people of Yemen. If we fail to do so, the catastrophe we have seen unfolding before our eyes will not only continue to claim lives but will scar future generations and the country for years to come.”
[See UN OCHA – L3 Emergencies below for Yemen cholera response plan and status of OCV as an intervention]