[US National Institutes of Health]

12 August, 2019

The Pamoja Tulinde Maisha (PALM [together save lives]) study is a randomized, controlled trial of four investigational agents (ZMapp, remdesivir, mAb114 and REGN-EB3) for the treatment of patients with Ebola virus disease. The study began on Nov. 20, 2018 in the Democratic Republic of the Congo (DRC) as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces.

As of Aug. 9, 2019, the trial had enrolled 681 patients toward an enrollment total of 725. Patients were enrolled at four Ebola Treatment Centers (ETCs) in Beni, Katwa, Butembo and Mangina. These ETCs have been overseen by staff from the Institut National de Recherche Biomédicale (INRB); the DRC Ministry of Health; and three medical humanitarian organizations: the Alliance for International Medical Action (ALIMA), the International Medical Corps (IMC), and Médecins Sans Frontières (MSF).

The Pamoja Tulinde Maisha (PALM) study logo. “Pamoja Tulinde Maisha” is a Swahili phrase which roughly translates to “Together Save Lives.”

The trial is monitored by an independent data and safety monitoring board (DSMB) that meets periodically to review interim safety and efficacy data and to make recommendations to the study team and the sponsors. As a result of their Aug. 9, 2019 review, the DSMB recommended that the study be stopped and that all future patients be randomized to receive either REGN-EB3 or mAb114 in what is being considered an extension phase of the study. This recommendation was based on the fact that an early stopping criterion in the protocol had been met by one of the products, REGN-EB3. The preliminary results in 499 study participants indicated that individuals receiving REGN-EB3 or mAb114 had a greater chance of survival compared to participants in the other two arms.

The principal investigators of the study, its statistician and its co-sponsors accepted this recommendation, and the ETC staff at the sites were promptly informed. In addition to limiting future patient randomizations to REGN-EB3 and mAb114, patients who were randomized to ZMapp or remdesivir in the last 10 days now have the option, at the discretion of their treating physician, to receive either REGN-EB3 or mAb114.

While the final analysis of the data can occur only after all the data are generated and collected (likely late September/early October 2019), the DSMB and the study leadership felt the preliminary analysis of the existing data was compelling enough to recommend and implement these changes in the trial immediately. The complete results will be submitted for publication in the peer-reviewed medical literature as soon as possible.

The study is co-sponsored and funded by the INRB and the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health; carried out by an international research consortium coordinated by the World Health Organization (WHO); and supported by four pharmaceutical companies (MappBio, Gilead, Regeneron, and Ridgeback Biotherapeutics).

NIAID, INRB and the WHO thank the extraordinary team of individuals who have worked under extremely difficult conditions to carry out this study, the members of the DSMB, and, most importantly, the patients who participated in the study and their families. It is through this type of rapidly implemented, rigorous research that we can quickly and definitively identify the best treatments and incorporate them into the Ebola outbreak response.

Image Credits: WHO/Chris Black, PALM.

[Sabin Vaccine Institute]

LONDON / WASHINGTON, D.C. – GSK and the Sabin Vaccine Institute (Sabin) announced exclusive agreements for Sabin to advance the development of the prophylactic candidate vaccines against the deadly Ebola Zaire, Ebola Sudan and the closely related, but lesser known, Marburg virus. No licensed vaccines against these three viruses are currently available. All three cause hemorrhagic fever with subsequent death in an average of 50 percent of cases [1,2]. More than 1,600 people have already died during the ongoing Ebola Zaire outbreak in the Democratic Republic of Congo (DRC) [3], leading the World Health Organization (WHO) to recently declare it a Public Health Emergency of International Concern [4].

Under the agreements between GSK and Sabin announced Tuesday 6 August, Sabin has exclusively licensed the technology for all three candidate vaccines and acquired certain patent rights specific to these vaccines. The three candidate vaccines were initially developed collaboratively by the U.S. National Institutes of Health and Okairos, which was acquired by GSK in 2013. The candidate vaccines, based on GSK’s proprietary ChAd3 platform, were further developed by GSK, including the Phase II development for the Ebola Zaire vaccine.

Sabin Chief Executive Officer Amy Finan commented, “As an organization committed to improving lives through immunization, Sabin is dedicated to preventing devastating outbreaks of the Ebola and Marburg viruses. Thanks to GSK’s longstanding engagement in global health, as well as its scientific expertise, the ChAd3 vaccine program is well positioned to be an effective weapon in the global community’s arsenal against Ebola. Sabin appreciates GSK’s years of work to advance the ChAd3 Ebola program and the productive partnership the two organizations have established. Sabin plans to continue the development and seek regulatory approval of Ebola and Marburg vaccines with our shared goal of making them available to the millions of people potentially at risk.”

Thomas Breuer, Chief Medical Officer of GSK Vaccines, said: “These agreements with the Sabin Vaccine Institute are an important next step in the fight against Ebola and Marburg viruses. Enabling Sabin to build on the scientific progress GSK has delivered up to Phase II increases the likelihood these candidate vaccines may help prevent potential future outbreaks, and exemplifies GSK’s approach to global health vaccines which supports partners in taking forward our innovations in a sustainable way. I am proud of the work that our world-leading vaccines scientists at GSK have contributed so far to the development of these vaccine candidates, including the Ebola Zaire candidate vaccine which has demonstrated encouraging results in studies to date.”

To further develop the ChAd3 Ebola and Marburg vaccines, Sabin has entered into a Research Collaboration Agreement with the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID). The ChAd3-based vaccines against Ebola Zaire, Ebola Sudan, and Marburg viruses have demonstrated a strong safety profile and encouraging immunogenicity results after being administered to more than 5,000 adults and 600 children, in 13 different clinical trials to date.
Specifically, the majority of the clinical volunteers were tested using the ChAd3 Ebola Zaire vaccine. In addition to numerous Phase I trials, the Ebola Zaire vaccine has been tested in three Phase II trials in Africa; two trials were conducted by GSK and one was conducted by the Partnership for Research on Ebola Virus in Liberia (PREVAIL), a clinical research partnership between NIAID and the Liberian Ministry of Health. The Ebola Sudan vaccine has been evaluated in three Phase I trials in Africa and the United States as a bivalent formulation with Ebola Zaire and will be evaluated in an upcoming Phase I study as monovalent formulation. A Phase I study of the Marburg vaccine is ongoing in the United States.

About the Sabin Vaccine Institute

The Sabin Vaccine Institute, a non-profit organization founded in 1993, is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Sabin’s R&D strategy focuses on continuing the development of candidate vaccines that have demonstrated early scientific value and target disease primarily impacting the world’s most vulnerable populations, but have little commercial value. The Blavatnik Family Foundation and the David E.I. Pyott Foundation provided seed funding to launch Sabin’s ChAd3 Ebola program. In past years, Sabin received more than $110 million for vaccine R&D programs from public and philanthropic funding sources, including the Bill & Melinda Gates Foundation, European Commission, Dutch Ministry of Foreign Affairs, Global Health Innovative Technology Fund and the Michelson Medical Research Foundation.

Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on Twitter, @SabinVaccine.

About GSK

GSK – a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK is the world’s leading vaccine company, with a portfolio that helps protect people throughout life and an innovative pipeline of 16 vaccines in development. Our vaccines help prevent illnesses such as hepatitis A and B, diphtheria, tetanus, whooping cough, measles, mumps, rubella, polio, pneumococcal disease, influenza, rotavirus, shingles and meningitis. At GSK, more than 17,000 people worldwide deliver around two million vaccine doses per day to people in 158 countries. For further information, please visit www.gsk.com.

About Ebola Zaire, Ebola Sudan and Marburg

Ebola Zaire, Ebola Sudan and Marburg are members of the Filoviridae virus family and are commonly referred to as filoviruses. All can cause severe hemorrhagic fever in humans and nonhuman primates. No therapeutic treatment of the hemorrhagic fevers caused by filoviruses has been licensed to date.

The 2014-2016 outbreak in West Africa, the largest Ebola outbreak in history, was caused by Ebola Zaire, starting in Guinea and then moving across land borders to Sierra Leone and Liberia. The outbreak eventually spread to 10 countries and took the lives of more than 11,000 people. The ongoing 2018-2019 outbreak in eastern DRC is also caused by Ebola Zaire and has claimed the lives of more than 1,600 people. The outbreak has been further complicated by significant security issues adversely affecting public health response activities, and on July 17, WHO declared it a Public Health Emergency of International Concern.

Marburg and Ebola viruses are transmitted to humans by infected animals, particularly fruit bats. Once a human is infected, the virus can spread to others through close personal contact or contact with bodily fluids. Isolation of infected people is currently the centerpiece of filovirus control.

Marburg was the first filovirus to be recognized in 1967 when a number of laboratory workers, including some in Marburg, Germany, developed hemorrhagic fever. Ebola was identified in 1976 when two simultaneous outbreaks occurred in northern Zaire (now the DRC) in a village near the Ebola River and southern Sudan. The outbreaks involved what eventually proved to be two different species of Ebola virus; both were named after the nations in which they were discovered.

Citations:

[1] WHO fact sheet, Ebola virus disease, accessed 30 July 2019 – available at: https://www.who.int/news-room/fact-sheets/detail/ebola-virus-disease
[2] WHO fact sheet, Marburg virus disease, accessed 30 July 2019 – available at: https://www.who.int/news-room/fact-sheets/detail/ebola-virus-disease
[3] WHO, Ebola in the Democratic Republic of the Congo – Health Emergency Update, accessed 30 July 2019 – available at: https://www.who.int/emergencies/diseases/ebola/drc-2019
[4] WHO press release, Ebola outbreak in the Democratic Republic of the Congo declared a Public Health Emergency of International Concern, 17 July 2019 – available at: https://www.who.int/news-room/detail/17-07-2019-ebola-outbreak-in-the-democratic-republic-of-the-congo-declared-a-public-health-emergency-of-international-concern

Image Credits: Sabin Vaccine Institute.

A transformation of global diets away from red meat consumption and towards healthier plant-based alternatives is critical for the world to combat climate change and land degradation that threatens food systems, while meeting the nutrition requirements of a growing population, says a new report by the Intergovernmental Panel on Climate Change (IPCC).

The report, Climate Change and Land, by the UN’s top body of climate scientists, said that food security could be jeopardised unless there is a shift away from red meat to diets richer in plant-based foods, such as fruits, vegetables and legumes, supplemented by animal protein sources like poultry, eggs, pork and milk products – whose production generates comparatively fewer climate emissions than red meat.

The IPCC report, released Thursday in Geneva, is likely to shift the conversation around health and climate change – which has tended to focus on the health impacts of extreme weather and air pollution – to the less-traveled territory of sustainable agriculture, nutrition and food security.

Photo: USDA/Lance Cheung

“Consumption of healthy and sustainable diets presents major opportunities for reducing GHG [greenhouse gas] emissions from food systems and improving health outcomes,” says the 1500-page report by 103 experts from 52 countries.

“Examples of healthy and sustainable diets are high in coarse grains, pulses, fruits and vegetables, and nuts and seeds,” and are “low in energy-intensive animal-sourced and discretionary foods (such as sugary beverages),” the report notes.

The new IPCC report now says that shifts may not only be critical to health, but to the basic food security of millions of people, as the global population is expected to grow by several billion more people by the end of the century.

“Replacing beef in the US diet with poultry can meet caloric and protein demands of about 120 to 140 million additional people consuming the average American diet,” the report points out.

And because red meat production requires such heavy inputs of land, energy, and water, as well as grain for cattle feed, reduced meat consumption would also lessen pressure on those resources, and thus vulnerability to climate change, the report emphasises. For example, beef products sold in the US account for just 4 percent of food products sold (by weight), but 36 percent of climate emissions associated with food production.

The strong health messages in the report echo those issued by WHO at the last UN Climate Change Conference in December 2018.

A WHO Health & Climate Change report released at the conference in Katowice, Poland stated that: “Moderation of red meat consumption by high-income populations could result in some of the largest reductions in climate change and the greatest improvements in health associated with the agricultural sector, as a significant proportion of agricultural emissions come from livestock, especially methane from ruminants.”

Global Food System Threatened on Multiple Fronts

The IPCC report goes even further to explain that the global food production system is threatened on multiple fronts. Those include climate-induced changes in weather such as more droughts and flooding, other climate and environmental drivers of land degradation and desertification, and finally non-climate stressors, such as population and income growth.

“Without inclusion of comprehensive food system responses in broader climate change policies… food security will be jeopardized,” it warns.

Despite a 30 percent increase in global food production since 1961, current food production patterns have led to tremendous nutrition imbalances, which affect both rich and poor. For instance, an estimated 821 million people are currently undernourished and 151 million children under 5 are stunted, while 2 billion adults are overweight or obese, the report notes, citing WHO nutrition data.

The Food and Agriculture Organization (FAO) estimates that based on current trends, 50 percent more food would need to be produced by 2050 in order to accommodate the world’s growing population. But IPCC concludes that based on current production models, such an increase would “engender significant increases in GHG emissions and other environmental impacts, including loss of biodiversity,” which would contribute to further spiraling of climate change.

The IPCC report therefore calls for more sustainable patterns of global food production as well as consumption, in order to both mitigate and adapt to a changing climate, using measures that would also improve nutrition and food security.

“Agriculture and the food system are key to global climate change responses,” the report concludes. “Combining supply side actions such as efficient production, transport, and processing with demand-side interventions such as modification of food choices, and reduction of food loss and waste, reduces GHG emissions and enhances food system resilience.”

“Such combined measures can enable the implementation of large-scale land-based adaptation and mitigation strategies without threatening food security from increased competition for land for food production and higher food prices.”

Food Waste and Food Loss Also Big Problems

Tackling another neglected aspect of food systems, the IPCC estimates that between 25 to 30 percent of all food produced is lost or wasted. Such waste and loss is in turn responsible for 8-10 percent of all climate emissions from agriculture and land use.

Food loss refers to any food that is lost in the supply chain between the producer and the market. Food waste refers to more deliberate disposal of food that would still be fit for consumption. “A large share of produced food is lost in developing countries due to poor infrastructure, while a large share of produced food is wasted in developed countries,” the report notes. In 2007, for instance, around 20 percent of the food produced went to waste in Europe and North America, while around 30 percent of the food produced was lost in sub-Saharan Africa. Problems with food waste thus reflect the underlying problems developed countries face with over-consumption and obesity, while food loss is a problem in countries where many people also face food insecurity.

Technical solutions to food loss include improved harvesting techniques, on-farm storage, infrastructure, transport, and packaging to keep food fresher for longer, although some of these can also create new costs on local environments, the report noted. Non-technical solutions could include changes in behaviours and attitudes across the food system.

“Food loss and waste can be recovered by distributing food surplus to groups affected by food poverty or converting food waste to animal feed,” the report states. “Unavoidable food waste can also be recycled to produce energy based on biological, thermal and thermochemical technologies.” Additionally, the report notes that strategies for reducing food loss and waste should consider gender dynamics – involving participation of women throughout the food supply.

Image Credits: USDA/Lance Cheung.

A new study suggests that the deadly drug-resistant fungus, Candida auris, may have adapted to warmer ambient temperatures caused by climate change, enabling it to survive in human body temperatures and infect humans with weakened immune systems, primarily in hospitals.

The study, published in the journal of The American Society for Microbiology in July, posits that Candida auris may have originated as an environmental fungus in wetlands, and due to its adaptation to rising temperatures, it may have infected birds as an intermediary species before further adapting to the higher body temperatures of humans.

It proposes that Candida auris “is the first example of a new pathogenic fungus emerging from human-induced global warming,” and warns that as temperatures continue to rise in the 21st century, it may be the first of other fungal lineages to become more thermally tolerant and capable of infecting humans.

Primarily affecting people with weakened immune systems in hospitals, between 30 and 60 percent of people infected with the fungus die, according US Centers for Disease Control (CDC) estimates.

Candida auris was first discovered in 2009 in Japan and isolated in human ear canals, one of the cooler parts of the human body. The fungus was identified as causing disease in 2011 in South Korea, and subsequently spread through Asia and Europe, first appearing in the United States in 2013.

Below is an illustration from the study of the possible factors operating on the emergence of Candida auris:

Image Credits: Science Media Centre.

NEW YORK – Negotiations over a planned United Nations political declaration on universal health coverage (UHC) reopened last week after about a dozen countries reportedly objected to language in the final draft covering two sensitive issues – sexual and reproductive health and rights (SRHR) and the health needs of migrants, refugees, internally displaced persons and indigenous peoples.

The United States was one of the 10-14 countries posing objections, sources told Health Policy Watch, after negotiations over the draft were closed on 24 July. The draft was then put under a “silence procedure” for five days, a period in which countries may file objections to effectively reopen debate.

“We regret to inform you that the silence procedure has been broken by several delegations on paragraphs 29, 68, 69, 70 and 71,” the Ambassadors of Georgia and Thailand, co-facilitators of the UN High-Level Meeting on Universal Health Coverage, wrote in a 29 July letter to the president of the UN General Assembly, María Fernanda Espinosa Garcés.

As of Monday, 5 August, it remained unclear which other countries besides the US had broken the silence procedure, and over which paragraphs. But time is now running out for negotiators to reach agreement on the declaration, which will be the focal point of the 23 September UN High-Level Meeting on Universal Health Coverage, bringing heads of state and other political and health leaders to the UN in New York.

After the silence was broken, the negotiations were elevated from the level of expert to the level of ambassador, in order to ensure that national representatives with the highest possible level of authority would be engaged to finalise the declaration as soon as possible, sources said.

The emerging dispute over language on SRHR and migrants represented a shift in focus of the debate over the painstakingly negotiated declaration text. Earlier debates had centred around language calling for greater public disclosure of prices of health products, more transparency for related research and development (R&D), and alternative incentives for R&D beyond conventional patent monopolies.  However, member states have now reached consensus on those issues, according to civil society observers.

The sections of text that are now under debate (noted below) include final draft paragraphs 29, 68 and 69 on women’s and girls’ rights to “sexual and reproductive health, free of coercion, discrimination and violence;” as well as paragraphs 70 and 71 on addressing “the particular needs and vulnerabilities of migrants, refugees, internally displaced persons and indigenous peoples.”

According to sources, the US objected to the language on SRHR in the declaration because it can be interpreted to include abortion, which is inconsistent with the US rule under the “Protecting Life in Global Health Assistance” policy to not commit funds to international health activities that are in any way related to abortion.

The recent US pick for the Ambassador to the UN in Geneva, Andrew Bremberg, has also vowed to oppose any UN resolutions that allow for abortion, even in the case of sexual violence and conflict.

Health Policy Watch previously reported that the silence procedure was likely to be broken according to sources close to the negotiations, and due to the fact that the paragraphs on SRHR had remained unchanged since the initial draft of the declaration, despite the controversy in previous UN fora that SRHR can be interpreted to include abortion.

Sources said that the United States ultimately hopes to reach consensus on the declaration before the 23 September high-level meeting.

More information on universal health coverage and the UN High-Level Meeting on UHC is available here.

Medicus Mundi International, an international network of health NGOs, published a comparison of the revisions of each of the drafts of the UHC declaration, since the initial “zero draft” was released on 17 May.

Final Draft Paragraphs 29, 68 and 69 on Sexual and Reproductive Health and Rights

  1. “Take measures to reduce maternal, neonatal, infant and child mortality and morbidity and increase access to quality health-care services for newborns, infants, children as well as all women before, during and after pregnancy and childbirth, including in the area of sexual and reproductive health;”
  1. “Ensure, by 2030, universal access to sexual and reproductive health-care services, including for family planning, information and education, and the integration of reproductive health into national strategies and programmes, which is fundamental to the achievement of universal health coverage, while reaffirming the commitments to ensure universal access to sexual and reproductive health and reproductive rights in accordance with the Programme of Action of the International Conference on Population and Development and the Beijing Platform for Action and the outcome documents of their review conferences;
  2. Mainstream a gender perspective on a systems-wide basis when designing, implementing and monitoring health policies, taking into account the specific needs of all women and girls, with a view to achieving gender equality and the empowerment of women in health policies and health systems delivery and the realization of their human rights, consistent with national legislations and in conformity with universally recognized international human rights, acknowledging that the human rights of women include their right to have control over and decide freely and responsibly on all matters related to their sexuality, including sexual and reproductive health, free of coercion, discrimination and violence;”

Final Draft Paragraphs 70 and 71 on the Health of Migrants, Refugees, Internally Displaced Persons and Indigenous Peoples

  1. “Ensure that no one is left behind, with an endeavour to reach the furthest behind first, founded on the dignity of the human person and reflecting the principles of equality and non discrimination, as well as to empower those who are vulnerable or in vulnerable situations and address their physical and mental health needs which are reflected in the 2030 Agenda for Sustainable Development, including all children, youth, persons with disabilities, people living with HIV/AIDS, older persons, indigenous peoples, refugees and internally displaced persons and migrants;
  2. Address the particular needs and vulnerabilities of migrants, refugees, internally displaced persons and indigenous peoples which may include assistance, health care, psychological and other counselling services, in accordance with relevant international commitments, and in line with national contexts and priorities;”

Image Credits: Wikimedia Commons.

Thursday, 1 August, marked the one-year anniversary of the Ebola outbreak in the Democratic Republic of the Congo (DRC), as daily reports of new infections, including 3 more cases in Goma along DRC’s border with Rwanda, fueled new concerns about regional spread of the deadly disease. Meanwhile, the World Health Organization called on international donors to close a huge gap in the estimated US$ 350 million required to fund just the health activities related to the response for the next 6 months.

Uncertainty also remained over whether the DRC government would agree to deploy a second vaccine, produced by Johnson & Johnson, alongside the Merck Ebola vaccine, that is already being used on health care workers and identified contacts of Ebola victims. The Merck vaccine, while highly effective, is only available in limited supplies, and the “ring vaccination” strategy being used has not succeeded in containing the outbreak.

“This first year, the Ebola anniversary, is not a milestone we ever wanted to mark,” said Dr Matshidiso Moeti, Director of the WHO Regional Office for Africa, in a press conference Wednesday, just two weeks after WHO declared the outbreak to be a Public Health Emergency of International Concern (PHEIC).

Some 13 new cases were reported by the DRC’s Ministry of Health on Thursday, including at least one new case in Goma, a city of around 2 million people. According to other reports, two more people had fallen ill, including both the wife and child of a miner who had died of Ebola in Goma on Wednesday. Rwanda reportedly closed its border, a heavily trafficked site, for several hours Thursday after learning of the new Ebola cases.

A joint statement by WHO and other UN agencies warned that the miner’s death “in such a dense population center underscores the very real risk of further disease transmission, perhaps beyond the country’s borders, and the very urgent need for a strengthened global response and increased donor investment.”

Administering an Ebola vaccine at Himbi Health Center in Goma this month. Photo: Olivia Acland/Reuters

The disease had previously passed into Uganda with three confirmed cases in June, but was effectively contained with no further spread into the country, largely due to the high level of preparedness of the Ugandan health system, which had previously dealt with outbreaks of Ebola. WHO is now increasing efforts to ramp up preparedness in other countries that share a border with the DRC, including Rwanda, Burundi and South Sudan, while continuing efforts to contain the disease in the DRC.

The WHO has called on international donors to increase funding to implement its 4th Strategic Response Plan (SRP) for the period of July through December, which is currently being developed and was reported to be released soon. WHO estimates the health response of the plan to cost US$ 350 million, significantly more than the estimated US$ 200 million contributed to the health response since the outbreak began in August 2018.

Dr Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, said in a press conference on Wednesday that WHO had firm funding commitments amounting to only about US$ 45 million of the US$ 350 million needed to fund the next 6 months of the public health response in the DRC, as well as better preparedness in neighboring countries. This leaves a gap of US$ 305 million to fully fund these two health pillars of the response plan.

Over the past two weeks, the United States pledged US$ 38 million to help end the ongoing outbreak, bringing the total amount of US assistance to US$ 136 million since the outbreak began last year. Additionally, the World Bank pledged to mobilise up to US$ 300 million for a financing facility to provide loans for the Ebola response at the national level, while the United Kingdom pledged £50 million to help deal with the outbreak.

However, Dr Ryan said that it was unclear what proportion of those funds would actually be dedicated to the health activities, as compared to other areas such as security and humanitarian efforts. He said WHO was still discussing the issue with the US and the UK, but anticipated that their contributions to the health efforts “would represent much smaller amounts” than the total pledges.

Effectiveness of the Merck Vaccine; Concerns Regarding Sufficiency of Supply

Controlling the outbreak has been largely supported by the widespread use of the experimental Ebola vaccine developed by Merck, shown to be up to 97 percent effective in preventing Ebola. But there are growing concerns regarding whether the supply of the Merck vaccine will be sufficient to meet the needs of the current vaccine strategy, and whether this strategy should be expanded.

Experts note that the Merck vaccine has likely saved hundreds if not thousands of lives in the current outbreak, and in light of this, they question whether the current outbreak may be even more severe than the previous West Africa outbreak, despite its lower death toll, which is fast approaching 2,000.

The vaccine has been used as part of a “ring vaccination” strategy to vaccinate contacts, and contacts of contacts, of people found to have Ebola. Recently, “pop-up” vaccination centers have also offered vaccination to anyone interested. While over 175,000 people have been vaccinated in the DRC according to WHO, many contacts exposed to the virus have evaded voluntary vaccination efforts, in part due to community mistrust, and in part due to the challenge of tracing every contact.

To meet the needs of these vaccination efforts, the dosage of the Merck vaccine has already been reduced by half in order to extend the supply of the vaccine. There are varying accounts regarding the actual amount of the vaccine that is available, with MSF reporting shortages of the vaccine on the ground in DRC, and WHO reporting that the supply has so far been sufficient.

“We have not experienced any shortage of vaccine on the ground so far during this outbreak,” a WHO official told Health Policy Watch, “but there are concerns about overall supplies of the vaccine. Accelerating the availability of vaccine is a priority.”

The WHO official said that “WHO continues to collaborate with Merck and to monitor and explore scenarios of Ebola vaccine supply and demand. Whether or not the available doses are sufficient to fulfill the demands depends on the evolution of the outbreak, the access to the communities and the successful expansion of the production of additional doses by Merck in early 2020.”

According to Merck, the company has 245,000 1.0 mL doses of the vaccine currently available, which is enough to vaccinate nearly 500,000 people at the reduced 0.5 mL dose. The company also reported plans to produce up to 550,000 additional 1.0 mL doses over the next 12 months.

Dr Mike Ryan of WHO’s Health Emergencies Programme said in Wednesday’s press conference that the “clinical efficacy of an individual dose of the vaccine is very high. The difficulty we face is if everybody doesn’t get vaccinated who needs to, then the overall effectiveness of vaccination as a program is lower than it should be, and that is the case. We haven’t been able to reach every high risk contact with the vaccine.”

Photo: WHO

WHO & Partners Recommend Introducing a Second Vaccine from Johnson & Johnson 

Organisations involved with the Ebola health response, including Médecins Sans Frontières (MSF/Doctors Without Borders) and Wellcome Trust, are calling on the DRC government to introduce the second experimental vaccine developed by Johnson & Johnson (J&J) as part of a more comprehensive vaccination programme, with a focus on prevention around the periphery of the high-transmission areas.

“WHO supports the introduction of a second vaccine, in line with the SAGE [Strategic Advisory Group of Experts on Immunization] recommendations, but subject to the appropriate national approvals,” the WHO official told Health Policy Watch.

Dr Ryan of WHO’s Health Emergencies Programme acknowledged in a 18 July press conference that “the [DRC] Ministry has expressed concerns about introducing a second vaccine, mainly around confusion of the local population… We are working through those issues with them… They still remain open to deploy in areas not affected. We are working with government and [the vaccine] consortium to find the solutions that would allow the vaccine to be deployed.”

“The J&J vaccine has been tested in various countries in over 6000 volunteers, has been proven safe and volunteers developed a strong immune response. Although it has not yet been used in an epidemic situation, and this has to be studied further, it seems likely that it will demonstrate a protective effect,” Dr Natalie Robert, MSF’s Operations Manager, told Health Policy Watch. 

“While obviously the role of the two different vaccines will have to be explained clearly to the affected population, and no-one will ever be forced to accept vaccination, we would encourage the deployment of this second vaccine as well as expanded use of the rVSV Merck vaccine in a coordinated strategy – both to allow more people in the region to access a potentially effective means of protection against Ebola, and to expand our arsenal of tools to better fight this and future epidemics. Any decision within DRC to do so would be welcome,” she said.

In an interview with Health Policy Watch earlier this month, Wellcome Trust’s Epidemics Lead, Josie Golding stressed that the J&J vaccine could be an important “preventative” tool complementing the Merck vaccine. Since there are 1.5 million doses available, it could also be deployed now in areas or populations at more peripheral risk, enhancing preparedness throughout the wider region.

Golding acknowledged that the concerns of the DRC government were understandable, insofar as the Merck vaccine, previously used in the 2014-15 West Africa epidemic, had developed a clear track record in the DRC emergency, provoking a very rapid and effective immune response. Notwithstanding, Golding said that the second vaccine could be used as a second-line of prevention.

Regarding the Merck vaccine, MSF said Wednesday in an update: “If doubts about its future availability persist, we ask the Congolese authorities to reconsider their opposition to using a second investigational vaccine to contain the outbreak.”

Burial workers dressed in protective gear carry the remains of a patient who died from Ebola in Beni, DRC. Photo: AP/Jerome Delay

The former DRC Minister of Health Oly Ilunga opposed the use of the second J&J vaccine, citing lack of sufficient clinical trials to establish efficacy; other safety risks; and potential complications of gaining community trust with the introduction of the new vaccine. He also questioned the likelihood that the vaccine would be decisive in curbing the outbreak, and said he did not support the use of the vaccine as an “experiment” on the DRC population.

In an interview in Le Monde, he said “[translated from French] we have had access to information from the US government forwarded to WHO regarding this vaccine, and its effectiveness is very clearly questioned. Nevertheless, people have tried to force it, in a non-transparent, non-respectful way. And to introduce the vaccine in full epidemic, without the approval of the Congolese health authorities. This is serious both from the point of view of medical ethics and in terms of attacks on the sovereignty of the DRC. I could not accept it.”

The former DRC Health Minister resigned last week after DRC President Felix Tshisekedi relieved him of the responsibility of leading the Ebola response, placing this responsibility directly under the presidency, to be managed by an Ebola response team led by Dr Jean-Jacques Muyembe Tamfum, Director of DRC’s Institut National de Recherche Biomédical. Dr Muyembe, who has been researching Ebola for four decades, has previously supported deployment of the second investigational vaccine under study conditions, and some speculate that he may be more likely to recommend introducing the second vaccine.

As of today, the Congolese government has not said whether or not it plans to introduce the second J&J vaccine.

Current Status of the Ebola Outbreak in DRC

“In the last year, there have been more than 2,600 confirmed cases, including more than 1,800 deaths in parts of Ituri and North Kivu provinces. Almost one in three ‘cases’ is a child. Every single ‘case’ is someone who has gone through an unimaginable ordeal. More than 770 have survived,” said the joint statement by WHO and other UN agencies.

Beni remains the hotspot, accounting for 61 percent of the 79 new cases last week, according to the latest WHO Africa Region situation report.

Source: WHO

“The public health response to an Ebola outbreak requires an exceptional level of investment; 100 per cent of cases must be treated and 100 per cent of contacts must be traced and managed,” the joint statement says, adding that WHO and other UN agencies “will continue to accelerate our response, and we ask partners old and new to do the same.”

“At this critical juncture, we reaffirm our collective commitment to the people of the DRC; we mourn for those we have lost; and we call for solidarity to end this outbreak,” it concludes.

This story was updated on 2 August.

Elaine Ruth Fletcher contributed reporting to this story. 

Image Credits: Olivia Acland/Reuters, WHO, AP/Jerome Delay.

80 percent of people with viral hepatitis lack access to services for prevention, testing & treatment. To address this gap, the World Health Organization calls on countries to invest in scaling up hepatitis services as part of their universal health coverage (UHC) plans.

On the occasion of World Hepatitis Day (28 July), WHO raised alarm over the lack of sufficient access to hepatitis services and funding to fight the disease, and in a press release made the case for increased investment by countries as well as affordable access to hepatitis medicines.

“On World Hepatitis Day, we’re calling for bold political leadership, with investments to match. We call on all countries to integrate services for hepatitis into benefit packages as part of their journey towards universal health coverage,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the WHO, quoted in the release.

People wait to receive free hepatitis testing and treatment in Lahore, Pakistan, at a dedicated Hepatitis Prevention and Treatment Clinic. Photo: PKLI

While member states broadly supported WHO’s 2016 hepatitis elimination strategy, with 124 out of 194 countries developing hepatitis plans, WHO noted in the release that there has been insufficient domestic investment to fight the disease – “over 40% of country plans lack dedicated budget lines to support elimination efforts.”

“By investing in diagnostic tests and medicines for treating hepatitis B and C now, countries can save lives and reduce costs related to long-term care of cirrhosis and liver cancer that result from untreated hepatitis,” the release said.

According to a WHO study published in The Lancet Global Health earlier this year, investing US$ 58 billion in hepatitis elimination through 2030 could avert 4.5 million premature deaths and lead to a gain of 51.5 million healthy life-years by 2030. It notes that this amount is small in relation to the overall cost of UHC, and compared to the cost of inaction.

The study also found that access to affordable medicines will be key to reaching targets for hepatitis elimination, noting that “if affordable HCV medicines remained inaccessible in 13 countries where medicine patents are protected, the additional cost of the ambitious scenario would increase to $118 billion.”

In the release, WHO highlighted the actions some countries are taking to scale up their public health services for hepatitis. “The Government of India, for example, has announced that it will offer free testing and treatment for both hepatitis B and C, as part of its universal health coverage plan.” WHO noted that this investment in hepatitis services was facilitated through the reduction in prices of hepatitis medicines.

Pakistan, a country with one of the highest rates of new hepatitis C infections, has also just launched a new infection control and injection safety plan aimed at stopping transmission, according to the release. It noted that Pakistan was also able to procure hepatitis C treatments at low prices.

Insufficient Access to Prevention, Testing & Treatment

There are five types of viral hepatitis infections – A, B, C, D and E – but over 95 percent of deaths are caused by chronic hepatitis B and C infections, according to the WHO release.

“Of the estimated 257 million living with hepatitis B infection:

  • 5% (27 million) knew their infection status in 2016.
  • Of those people diagnosed, only 17% (4.5 million) received treatment in 2016.
  • In 2016, 1.1 million people newly developed chronic hepatitis B infection—a primary cause of liver cancer.

Of the estimated 71 million people living with chronic hepatitis C infection in 2015:

  • 19% (13.1 million) knew their infection status in 2017.
  • Of those people diagnosed, 15% (2 million) received curative treatment in that same year. Overall, between 2014 and 2017, 5 million people have received hepatitis C curative treatment.
  • In 2017, 1.75 million people newly developed chronic hepatitis C infection.”

Image Credits: PKLI .

The last decade has seen dramatic progress in the fight against tobacco, with some 136 countries having implemented policies such as smoking bans in public places, higher taxes or graphic packaging on tobacco products. But there is a huge unmet demand for services to help smokers quit, a critical intervention that lags behind other tobacco control measures, according to the latest World Health Organization report on the tobacco epidemic, launched Friday.

Today, 5 billion people live in countries that have implemented at least one of WHO’s six recommended tobacco control measures – four times more people than a decade ago. This, however, still leaves 2.6 billion people unprotected by tobacco control policies, and “at risk from the health and economic harms caused by tobacco use,” the report warns. The report also found that only 2.4 billon people, or 32 percent of the world’s population, live in countries providing comprehensive smoking cessation services.

WHO’s “Report on the global tobacco epidemic, 2019: Offer help to quit tobacco use” was launched Friday in Rio de Janeiro, Brazil, the second country after Turkey to implement all six of the WHO-recommended tobacco control measures, known as MPOWER.

“Today’s tobacco users will make up the majority of future tobacco-related deaths, which will disproportionately affect low- and middle-income countries,” Dr Tedros Adhanom Ghebreyesus, Director-General of the WHO, said in the report, highlighting the importance of tobacco cessation services in achieving universal health coverage (UHC).

While the report found that per capita tobacco use has declined in most countries, population growth has kept the total number of people using tobacco “stubbornly high” – today, there are an estimated 1.1 billion smokers, of which 80 percent live in low- and middle-income countries, according to a WHO press release that accompanied the report.

“More countries are making tobacco control a priority and saving lives, but there’s still much more work to be done,” said Michael Bloomberg, WHO Global Ambassador for Noncommunicable Diseases (NCDs) and Injuries and founder of Bloomberg Philanthropies, in the report. “The WHO’s new report shines a spotlight on global efforts to help people quit using tobacco and it details some of our most important gains.”

But these global efforts have faced a number of setbacks and challenges, including political obstacles and interference from the tobacco industry. “[T]he fight against an aggressive and ever evolving industry is far from over,” Bloomberg noted in the report.

A new database, released yesterday by STOP (Stopping Tobacco Organizations and Products), an initiative of Bloomberg Philanthropies, is aimed at exposing the groups that help tobacco companies undermine public health, in order to reduce support for the industry and aid in global efforts to implement tobacco control measures.

In 2007, the WHO Framework Convention on Tobacco Control (FCTC) launched its MPOWER measures, designed to promote government action across a set of evidence-based interventions to reduce tobacco use, save lives and reduce healthcare costs. These include:

  • Monitor tobacco use and prevention policies.
  • Protect people from tobacco smoke.
  • Offer help to quit tobacco use.
  • Warn people about the dangers of tobacco.
  • Enforce bans on tobacco advertising, promotion and sponsorship.
  • Raise taxes on tobacco.

“Quitting tobacco is one of the best things any person can do for their own health,” Dr Tedros said, quoted in the release. “The MPOWER package gives governments the practical tools to help people kick the habit, adding years to their life and life to their years.”

Progress Slow on the “O” of MPOWER: “Offer Help to Quit Tobacco Use”

While there is overall progress in the fight against tobacco, the report highlights the important gap of unmet demand for cessation services, noting that many tobacco users want to quit and need help to do so.

There are 2.4 billion people living in countries now providing comprehensive cessation services, which is 2 billion more than in 2007, but only 23 countries are providing cessation services at the best-practice level.

“Population-level, cost-effective tobacco cessation interventions must be a priority for countries. At the same time, innovation is to be encouraged and mobile technologies should be fully harnessed to improve access to large and hard-to-reach populations,” Dr Tedros said in the report.

Tobacco cessation services include counseling by primary health care providers, cost-covered nicotine replacement therapy, national toll-free quit lines and mobile-based services to reach larger populations.

The report notes that progress has been slower in the “O” of MPOWER – “Offer help to quit tobacco use” – compared to other measures since 2007, and that the proportion of the world’s population covered by comprehensive cessation services actually decreased by 1 percent between 2016 and 2018.

It clarified that this slower overall progress is still significant, with best-practice adoption of cessation services increasing from “10 countries (5% of the world’s population) in 2007 to 23 countries (32% of the world’s population) in 2018 – meaning 2 billion more people are now protected by this measure.”

In addition to the 23 countries implementing cessation support policies at the highest level, 116 more countries are providing “fully or partially cost-covered services in some or most health facilities, and another 32 offer services but do not cost-cover them, demonstrating a high level of public demand for support to quit,” the release noted.

The report details that “four countries with a combined population of 60 million (Czechia, Saudi Arabia, Slovakia, Sweden) began offering comprehensive cessation services in the past 2 years. Disappointingly, however, the number of people protected by these countries newly adopting best practice is offset by six countries – representing 97 million people – that dropped out of the best-practice group in the same period.”

“Of these countries that reduced services, five were high-income (Brunei Darussalam, Estonia, Israel, Malta and Panama) and one was middle-income (Islamic Republic of Iran). Three of the countries (Brunei Darussalam, Israel and Panama) discontinued their toll-free quit line, and the other three discontinued cost-coverage of nicotine replacement therapy (NrT),” it said.

“There has been incredible progress in the 11 years since MPOWER monitoring began, including millions of lives saved, but it is only the beginning. It is important that we all recommit to ensuring all the people of the world are protected fully from the great harms of the tobacco epidemic,” the report concludes.

Image Credits: WHO.

NAIROBI – Neonatal sepsis is one of the leading causes of newborn deaths globally, and increasing pathogen resistance to available first-line treatments is a prime example of rising antimicrobial resistance.

That is why the Global Antibiotic Research and Development Partnership (GARDP) – a non-profit research organisation that develops new or improved antibiotic treatments – is seeking alternatives. GARDP’s first clinical trial of one such candidate, Fosfomycin, is taking place right now in the coastal region of Kenya to determine safety and appropriate dosing for infants.

GARDP’s research was one feature of a three-day conference that took place in Nairobi this week (23-25 July) on tackling antimicrobial resistance in Africa. The ReAct Africa and South Centre Conference, “Achieving Universal Healthcare While Addressing Antimicrobial Resistance,” drew together experts from 24 African countries to the event, co-sponsored by the United Kingdom-based Fleming Fund, along with the South Centre, Wellcome Trust, Swedish International Development Agency Sida, and others.

Antimicrobial resistance (AMR) is fast becoming a major public health problem worldwide. Estimates from a recent UN report suggest that up to 10 million people could lose their lives annually by 2050 if nothing is done to address the AMR threat, which can render anti-viral and anti-fungal medications, as well as antibiotics, ineffective. Along with overuse of medications in some countries, the lack of access to safe, affordable medicines in low- and middle-income countries can drive AMR, conference participants stressed.

“If we don’t address the problem of the inappropriate use and misuse of antibiotics then this is leading us to more untreatable infections, as well as infections that are more costly and difficult to treat,” said Viviana Muñoz Tellez – Coordinator, Health, Intellectual Property and Development Programme South Centre during the conference.

Lack of Data on AMR a Major Barrier

Addressing this problem means formulating appropriate policy, which ultimately is informed by data. However, availability of AMR data, especially in developing countries has been, and continues to be, a challenge. So generating better data is one key area in which players in the antimicrobial debate are increasingly focused. This is particularly true of the Wellcome Trust, a research charity organisation based in the UK, which has made surveillance and monitoring of AMR one of the pillars guiding it’s 5-year AMR programme.

“We are trying to build an evidence-base and improve data that is available for all sorts of decision-making – at the clinical level, at the doctor-patient level and policy-making levels,” said Jeremy Knox, Policy and Advocacy Lead on AMR at Wellcome Trust. Welcome Trust is working with WHO as well as research and civil society institutions around the world to explore how it can make better use of alternative and conventional sources of data. This includes data from the private and pharmaceutical sectors, as well.

Wellcome has also been supporting efforts to develop country by country evidence of what is the health burden of AMR today. And it is working with the Innovative Medicines Initiative (IMI) to improve rapid diagnostics, which can help ensure the right treatment and avoid unnecessary use of antibiotics.

Presenting political leaders with the data and the evidence showing why AMR is such a significant problem will help them prioritise actions to address the issue, Knox said, adding: “We are interested in behaviour change… We are trying to understand how we can turn awareness into lasting behaviour change, how we we can bring behavioural science to bear in AMR, be that public behaviour or even veterinarian behaviour.”

Jeremy Knox, Policy Advocacy Lead on AMR at Wellcome Trust

Counterfeit & Substandard Medicines Another Major Driver 

While overuse or misuse of antibiotics play a major role in the evolution of microbes, the same is true of the use of counterfeit and substandard medicines. This is a major contributing factor in exacerbating resistance, said Philip Nguyen, Director of the Quality Institute, US Pharmacopeial Convention (USP).

“There is a common saying in the US that what doesn’t kill you, makes you stronger. This is true of microbes [which go] through an incomplete course of antimicrobial treatment,” said Nguyen, who is also Advisor to MedsWeCanTrust Campaign (MWCT), a platform promoting the right to safe and quality medicines.

Counterfeits and substandard medicines may not have sufficient active ingredients to kill the pathogen in question. In other instances, they may not even contain any active parts or ingredients in the first place. Or, they may have the wrong type of active ingredients, in which case, they could be the wrong drug used to treat the problem.

“Either way, you are creating a system or environment to encourage resistance for microbes, which may lead to overuse of drugs” he explained. According to Nguyen, the need to prevent, detect and respond to pathogen resistance cannot be overstated. But the need to understand the complex interactions between counterfeit drugs and the human body is equally important.

“That is why there is active research happening all around the world, which USP is a part of, that tries to find out what happens when the body interacts with substandard or broken down components of medicine,” said Nguyen. He called for better market surveillance of drugs, especially the substandard versions, which is the job of regulators and regulatory systems.

Philip Nguyen, Director of the Quality Institute, US Pharmacopeial Convention

How Universal Health Coverage Can Combat AMR

Universal health coverage can therefore lead to better AMR control – by assuring people’s access to a reputable supply of medicines – and to advice from medical practitioners about how they should be used. Ghana is one example of this principle in action. It has provided health insurance coverage for the majority of its population – 18 million people out of a population of 28 million.

As a result, pregnant women and infants are now able to access healthcare at zero cost, courtesy of the universal health insurance programme, initiated in 2006. Since the programme also provides for key drug products free of charge, through hospital suppliers, patients do not have to buy products themselves from the pharmacy.

“All you need to do is simply present the health insurance card when seeking treatment and the medicine is provided free of charge,” said Boi Kikimoto, Head of Public Health and Food Safety, AMR Focal Point of Ghana. According to Kikimoto, provision of health insurance will go a long way towards addressing the issue of self-medication, which can in turn lead to over-use or misuse of drugs, resulting in antimicrobial resistance. Funding for this insurance programme comes from a small value-added tax imposed on goods and services sold in the country.

Repurposing Medicines to Combat AMR-Resistant Bacteria

As for the GARDP study of Fosfomycin, it is an example of the kind of research that needs to be done to find alternative treatments in cases where pathogen resistance has already developed. This is already the case for neonatal sepsis, a bacterial infection of the blood – where the WHO recommended treatment regime has not been updated in more than 50 years, and pathogen resistance to the first line of treatment, Ampicillin and Gentamicin, has already become significant in East Africa and South-East Asia.

Fosfomycin is approved in Europe and the US, but only for the treatment of uncomplicated urinary tract infection or cystitis. It has also been shown to be efficacious against neonatal sepsis. However, there is no information on neonatal safety and dosing for sepsis.

The Kenyan study of the safety and pharmacokinetics (the movement of a drug in and out of the body) of Fosfomycin will establish this information. This will also serve to generate data on drug resistance and effectiveness or lack thereof of the new treatment.

“GARDP is re-purposing an existing drug (Fosfomycin) for use in a combination regimen for the treatment of clinically diagnosed neonatal sepsis,” explained Dr. Monique Wasunna, Director of the Africa Regional Office of Drugs for Neglected Diseases initiative (DNDi).

GARDP was founded in 2016 by DNDi in partnership with the World Health Organization (WHO). It was hosted within DNDi before becoming a legal entity in 2019. GARDP is also conducting a global observation study in 19 sites in 11 countries to collect clinical information on confirmed sepsis in up to 3,000 newborns.

“So, we are trying to perform clinical trials to find out if a combination of Fosfomycin and another drug might be a better alternative to Ampicilin/Gentamicin that is currently being used,” reiterated Wasunna. The pharmacokinetics study is over – enrollment having been completed in February this year.

Once the safety issues of treatment are resolved and the pharmacokinetics results are satisfactory, a bigger clinical trial of the combination therapy will follow in a number of countries. In addition to Kenya, the study will be conducted in Uganda and Thailand – countries that have Ampicilin/Gentamicin as the first line treatment against neonatal sepsis.

“So, we are just doing the safety analysis and hopefully we will have the results by the end of August,” explained Wasunna. The new, bigger study involving several countries will potentially take place in 2020. It will take another two to three years before the effectiveness of a combination therapy involving Fosfomycin is known.

The first, smaller study in Kenya involved 120 patients, half of whom were put on Fosfomycin medication. The other half were on the current Ampicilin/Gentamicin regimen. However, the Phase III clinical trials will involve a minimum of 100 participants in each country taking part.

Lucy Andrews, Head of The Fleming Fund addresses the 2019 ReAct Africa and South Centre Conference by video, while Mirfin Mpundu, Conference Head, looks on from podium

Image Credits: GARDP, Geoffrey Kamadi.

[Wellcome Press Release]

A world-first research project will unravel how human embryos develop in the first weeks and months after fertilisation, improving our understanding of fertility, birth defects and regenerative medicine.

The £10 million Wellcome-funded Human Developmental Biology Initiative (HDBI) will build a ‘family tree’ of how cells divide and specialise following fertilisation*, to understand how tissues and organs develop and reveal new insights into how this process can go wrong.

Coloured scanning electron micrograph of a human embryo at the eight-cell stage. Photo: Science Photo Library

Around 3% of babies are born with developmental defects – problems that often start very early in pregnancy such as heart defects, spina bifida and cleft palate. But we know very little about why and how they happen.

The Initiative will create ‘family histories’ of cells from four particular time-points in development or organ systems – the early human embryo, the brain and spinal cord, the blood and immune system, and the heart and lungs.

For many years, developmental studies have relied on cellular and animal models. While this has provided important information, it’s also become clear that our understanding of early human development remains extremely limited.

To address this, the HDBI will tackle some of the biggest challenges that are holding the field back. Very few labs have access to human embryo tissue samples meaning that key pieces of research that will underpin the field have yet to be carried out. And when available, this tissue is incredibly diverse, reflecting the genetic and environmental origins, making insights hard to define.

By bringing the research community together, along with recent advances in embryo and organoid models, more sophisticated imaging techniques and genome editing mean that researchers can now gain an unprecedented insight into human development.

Professor Rick Livesey, based at UCL and one of the researchers leading the HDBI, said: “We know surprisingly very little about how humans develop. By understanding what is ‘normal’ in development we will be able to see how things can go wrong, offering new avenues for research. In addition, the insights from this work could help regenerative medicine reach its full potential.”

The project will involve donated human embryos and human foetal tissue. The UK has a strong regulatory and legal framework and the HDBI will work within and respect these regulations. The Initiative will actively work to consider the ethical issues raised by this growing area of research and includes a specific ethics programme and public engagement programme.

Andrew Chisholm, head of cellular and developmental science at Wellcome, said: “This new initiative brings together a diverse group of biologists from across the country to share their expertise and work together to build a ‘family tree’ of how different cells and tissues come together to form organs. This will create a treasure trove of data and technologies that will be made available to the community.

“Thanks to new techniques and technologies to study human development the HDBI will provide insights that could help our understanding of developmental disorders

The Human Development Biology Initiative is a five-year programme which involves researchers from UCL, the Francis Crick Institute, the Babraham Institute, University of Oxford, the University of Cambridge, the University of Dundee and the University of Newcastle. In addition, it will partner closely with the MRC-Wellcome Human Developmental Biology Resource.

Image Credits: Science Photo Library.