ViiV’s Deborah Waterhouse and MPP’s Charles Gore announcing the new licensing agreement.

MONTREAL – Ninety countries will benefit from a voluntary licensing agreement announced on Thursday that will enable generic companies to produce a long-acting injectable antiretroviral, cabotegravir (CAB-LA), to protect people from HIV infection.

CAB-LA’s manufacturer, UK pharmaceutical company ViiV, has given the license to the Medicines Patent Pool (MPP) for patents in least-developed, low-income, lower-middle-income and sub-Saharan African countries. 

CAB-LA is administered as an injection every two months for pre-exposure prophylaxis (PrEP), and is aimed at protecting those most at risk of HIV infection, including sex workers, people injecting drugs, men who have sex with men, and transgender people.

These groups, designated “key populations” by UNAIDS because of their vulnerability to HIV, accounted for 70% of new infections in 2021, according to UNAIDS.

“From here we’ll work with the MPP to help enable generic manufacturing as quickly as possible. We’ve committed to offering a not-for-profit price for public programmes in low-income, least developed, and all sub-Saharan African countries until a generic is available,” ViiV’s Deborah Waterhouse told a media briefing on Thursday, on the eve of the opening of the International AIDS Conference on Friday.

ViiV also produces the antiretoviral drug, dolutegravir, and has a voluntary license for this with the MPP.

“By applying this proven modern model to prevention and sharing our intellectual property and enabling generic versions of CAB-LA for PrEP, we hope we can play an important role in preventing new cases of HIV, particularly in women and girls, where challenges with adherence, limited efficacy and stigma have hindered the impact of current PrEP options,” said Waterhouse.

Currently, PrEP has been restricted to oral pills that need to be taken every day, which is often hard for the high-risk groups that PrEP is aimed at.

New coalition to address price

MPP executive director Charles Gore said that the license “enables MPP to issue sub-licences to qualified manufacturers who will then develop generic versions”. 

Aside from the 90 countries covered, language in the licence indicates that additional countries where there are no patents or patent applications may also qualify for generic versions, said Gore. 

“Licensees will be required to obtain approval from WHO pre-qualification or from a stringent regulatory authority. The sales are almost all royalty-free. Just in 10 countries, they’ll be a 5% royalty on net sales,” said Gore.

CAB-LA was approved for the prevention of HIV infection by the US Food and Drug Administration (FDA) in December 2021, but its price per vial is around $3,700.

Tenu Avafia, Deputy Executive Director of Unitaid

A new coalition to accelerate access to long-acting PrEP was also announced on Thursday. Convened by the World Health Organization (WHO), Unitaid, UNAIDS and The Global Fund, and with HIV prevention advocacy group AVAC as the secretariat, the coalition will develop strategies to overcome access barriers to new PrEP options, including the price in wealthier countries.

ViiV is also collaborating with Unitaid, MedAccess and donors Children’s Investment Fund Foundation (CIFF) and the Gates Foundation, to speed up equitable access to its product.

“New HIV prevention options now reaching the market, such as injectable cabotegravir, hold the promise to transform HIV prevention,” Tenu Avafia, Deputy Executive Director of Unitaid, said.

“But we must move far more quickly than we did with oral PrEP if we are to have real impact on the epidemic. This new coalition being formed will prioritize the acceleration of affordable, equitable and widespread access to injectable long-acting cabotegravir for PrEP without delay.

AVAC executive director Mitchell Warren described the agreement as “a major step forward, and we applaud ViiV Healthcare and MPP for agreeing to a voluntary license”.

“But this is just one step, and there is much more to be done. All stakeholders need to step up to accelerate access to CAB for PrEP at the lowest possible price while building a sustainable market for generics.”

Community representative Jacque Wambui from Afrocab said that community partners had been encouraged to see the responsiveness and engagement from global partners .

“However, we recognize this is just the first step on this path for long-acting cabotegravir for PrEP. Speedy technology transfer and low-cost pricing have still not been secured. Until then, the promise of accessible, affordable CAB-LA will not be realized. Afrocab and our community partners will continue to advocate around these issues until they are resolved.”

New WHO guidelines, new research

The WHO also released new guidelines for the use of CAB-LA on Thursday.

“Long-acting cabotegravir is a safe and highly effective HIV prevention tool, but isn’t yet available outside study settings,” said Meg Doherty, WHO director of HIV, Hepatitis and Sexually Transmitted Infections. 

“We hope these new guidelines will help accelerate country efforts to start to plan and deliver CAB-LA alongside other HIV prevention options, including oral PrEP and the dapivirine vaginal ring.”

Meanwhile, results from a recent study that followed 3,223 women who were using PrEP – both oral pills and the CAB-LA injections – were also released at the media briefing.

The women, based in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, and Zimbabwe, had initially been part of a clinical trial to compare oral and injectable PrEP (CAB-LA).

The trial was unblinded in November 2020 after proving that CAB-LA was 66% more effective than oral PrEP, but the trial participants continued to use either oral or injectable PrEP while waiting for a protocol amendment to enable all to get open-label CAB-LA.

In the year after the unblinding, three participants using CAB-LA became infected with HIV and 20 in the group using the oral pills.

“Women in sub-Saharan Africa bear a disproportionate burden of HIV and while there have been incredible efforts to expand access to oral PrEP, many women experienced social and structural barriers to daily pill taking,” said Dr Sinead Delany-Moretlwe, the trial’s protocol chair and research professor at the University of the Witwatersrand in South Africa.

Researchers also announced that the first trans-specific analysis of data confirmed that CAB-LA is a safe and highly effective HIV prevention option for trans women.

The study involved 570 transgender women, 58% of whom were using gender-affirming hormone therapy, and CAB-LA was also safe and effective for those on hormonal treatment.

Agreement is ‘limited’

Reacting to the licensing announcement, Medecins sans Frontieres (MSF) described it as “a welcome yet limited step given its restrictive geographical scope”.

“The license allows only up to three generic companies globally to produce and supply,” said Leena Menghaney, South Asia head of the MSF Access Campaign. “It is disappointing to note that a number of developing countries with generic manufacturing capacities in Latin America and Asia are currently excluded from this license agreement.”

Health GAP Executive Director Asia Russell said that the agreement was the result of activist pressure as “just four months ago, ViiV announced it would not pursue voluntary licensing for CAB-LA to allow generic manufacturing and accessible pricing for low- and middle-income countries.

“But generics won’t reach the market for years and years. ViiV must cut the price now to one equivalent to the price of oral PrEP, and make sufficient supply available so people can actually access it,” added Russell.

“This license is not open, doesn’t include tech transfer, and doesn’t include all countries where it is needed. With the current direct and indirect territorial coverage included in this licensing deal, there are still far too many people left behind, including those who stand to benefit the most from this scientific advancement. Brazil is an excluded country–when gay men and other men who have sex with men and trans women participated in clinical trials that delivered the data to make CAB-LA a marketable product for ViiV.”

Image Credits: Diana Polekhina/ Unsplash.

UN General Assembly resolution recognizes human right to a healthy environment.

UNGA decision comes on the heels of an about-face by coal-promoting US Senator Joe Manchin, to support the inclusion of a climate mitigation package as part of President Joe Biden’s flagship domestic spending package, potentially enabling its passage after months of deadlock.

As regions as diverse as Southeast Asia, Europe and the Americas scorched under record July temperatures, the UN General Assembly on Thursday adopted a landmark resolution recognizing the human right to a “clean, healthy, and sustainable environment” as an indelible part of broader human rights guaranteed by the global governance body.

The historic resolution was five decades in the making said the UN Environment Programme, that described it as a “victory for people and the planet.” UN Secretary General Antonio Guterres called it “an important tool for accountability and climate justice.”

Until now, legal recognition of the right to a healthy environment in binding UN treaties and Conventions is patchy and vague. The General Assembly resolution sets the stage for more explicit recognition of this right in existing and future UN legal instruments – including new climate measures negotiated at the COP 27 UN Climate Conference in November.

Climate mitigation advocates face an uphill battle to win approval at the Conference of Parties, due to be held in Sharm el Sheikh, Egypt for more ambitious climate commitments that would  keep average temperature rise under 1.5 C during this century.  Under existing national commitments made last year at COP26 in Glasgow, the world remains on a trajectory to well exceed that target.

UN Vote comes hours after key US Senator withdraws opposite to US climate bill

Sun obscured by heavy smoke during last summer’s forest fire season in the United States.

Hours before the UN General Assembly vote, news of a dramatic turnabout in Washington DC by coal-promoting West Virginia Senator Joel Manchin, to support a raft of new US tax credits and incentives promoting green tech and renewable energy. His sudden turnabout,  raised hopes among climate advocates that the United States could indeed assume a stronger leadership role in the global drive to sharpen climate commitments – which fail woefully short of what is needed to keep average temperature rise below 1.5 C in this century.

After weeks in which record US temperatures, wildfires and in other places, violent floods have vividly underscored that the climate crisis is real, Manchin said that he would support a massive US domestic tax and spending bill that includes $369 billion in credits and financial incentives for clean energy and climate mitigation –  as long as the package “invests in the technologies needed for all fuel types – from hydrogen, nuclear, renewables, fossil fuels and energy storage” and “does not arbitrarily shut off our abundant fossil fuels”.

The domestic spending package includes tax incentives and finance for renewable energy projects, climate friendly agriculture and other green-tech, and pollution reduction, as well as a $7,500 tax break on new electric vehicles. That includes $30 billion in production tax credits for solar panels, wind turbines, batteries and processing of minerals input; $10 billion for clean industrial tech, , according to the New York Times and other media reports.

And the bill would include $60 billion to clean up pollution hotspots in low-income communities; $27 billion for a “green bank” aimed at delivering financial support to clean energy projects; $20 billion to cut agriculture emissions. sector; and a methane fee on leaks from oil and gas facilities.

UN General Assembly delivered a “victory for people and planet”

Meanwhile, the UN Environment Programme’s Inger Andersen celebrated the passage of the UN General Assembly Resolution as a “victory for the planet and people.”

In a press statement, she noted that billions of people are suffering “under the weight of the triple planetary crisis of climate change, nature and biodiversity loss, and pollution and waste,” and the UN move ” will help people stand up for their right to a safe climate, their right to breathe clean air and their rights to access clean and safe water, adequate food, healthy ecosystems and nontoxic environments.”

But now we must build on this victory and implement the right, because the triple planetary crisis is a huge threat to present and future generations. If nations implement this right fully, it will change so much – by empowering action on the triple planetary crisis, providing a more predictable and consistent global regulatory environment for businesses, and protecting those who defend nature.

“The resolution has the potential to be a turning point for humanity, improving the life and enjoyment of human rights of billions of individuals as well as the health of our extraordinary planet,” said the UN Special Rapporteur on human rights and the environment, David R. Boyd in another statement.

“The health and quality of life of everyone directly depend on clean air to breathe, safe water to drink, sustainably produced food to eat, non-toxic environments, a safe climate, and healthy biodiversity and ecosystems,” the UN expert said. “The human right to a clean, healthy and sustainable environment, as recognised universally today, includes all of those substantial elements.”

Draft US legislation also moves to lower prescription drug costs

The new US tax and spending bill also includes a landmark initiative to lower the cost of healthcare and particularly of prescription drugs in the US – where costs of the same medications are often far higher than those in Canada or other developed countries, including the European Union.

To lower costs, the draft US legislation would empower Medicare for the first time ever to directly negotiate with pharma providers over the price of prescription drugs that it procures, beginning in 2023. It would also cap out-of-pocket costs for older people drawing Medicare at $2000 a year, provide free vaccines to seniors – and expand subsidies and provisions of the Affordable Care Act, which aims to provide access to health insurance to all Americans.

The plan would raise an estimated $313 billion by closing tax loopholes used by some of the largest US corporations to reduce their tax rates below the US 21 percent corporate income tax rate.  And the plan would raise another $14 billion by reducing preferential tax treatment of venture capitalists and private equity firms.

Image Credits: Todd Petit.

UNAIDS director Winnie Byanyima (centre), with Dr Adeeba Kamarulzaman, co-chair of the International AIDS Society, and PEPFAR’s head, Dr John Nkengasong

MONTREAL – Progress against HIV has slowed down during the COVID-19 pandemic as donors pull back, countries test and treat fewer people and miss key targets, UNAIDS revealed on Wednesday.

“Progress in prevention and treatment is faltering around the world, putting millions of people in grave danger. Eastern Europe and central Asia, Latin America, and the Middle East and North Africa have all seen increases in annual HIV infections,” UNAIDS director Winnie Byanyima revealed at the release of the global body’s annual report, aptly named In Danger.

“In Asia and the Pacific, UNAIDS data now shows new HIV infections are rising where they had been falling. Action to tackle the inequalities driving AIDS is urgently required to prevent millions of new HIV infections this decade and to end the AIDS pandemic.”

Countries with the biggest increases in new HIV infections include Philippines, Madagascar, Congo and South Sudan, according to the report, issued just ahead of Friday’s opening of the 24th Annual AIDS conference, which opens Friday in Montreal, Canada. 

‘Key populations’ account for 70% of new infections

Some 70% of new infections are in groups designated by UNAIDS as “key populations” for their particular vulnerability to infection: men who have sex with men (MSM), sex workers, transgender people, people who inject drugs, and prisoners.

In El Salvador between 2019 and 2021 HIV prevalence among MSM attending HIV testing clinics almost doubled, and increased eight-fold among transgender people. 

UNAIDS key populations data show MSM have 28 times the risk of acquiring HIV compared to people of the same age and gender identity. People who inject drugs have 35 times the risk, sex workers 30 times the risk, and transgender women 14 times the risk. “UNAIDS data showed insufficient progress on removing punitive laws that increase the risk of HIV infection and death for marginalized people including LGBTI people, people who inject drugs, and sex workers,” according to the report.

“Closing the inequalities by removing punitive laws, promoting human rights and expanding community-led services is working in countries like Thailand,” said Byanyima.

Gender inequality is also pushing infection, with an adolescent girl being infected with HIV every two minutes. In sub-Saharan Africa, girls and young women are three times more likely to acquire HIV than boys and young men their age. 

“Effective pandemic response means addressing gender inequalities. Botswana, for example, extended universal secondary education and found that for each additional year of schooling, there was a 12% reduction in girls’ risk of acquiring HIV,” said Byanyima.

Racial inequalities also exacerbate HIV risk. In the UK and US, HIV declines have been greater amongst whites than blacks. In Australia, Canada and the US, indigenous communities are disproportionately affected by HIV. 

Caribbean, central and west Africa make progress

“We have to sound the alarm. But let me be clear: this is not a council of despair. It is a call to action because even amidst these crises, we see remarkable resilience in some cases,” noted Byanyima. 

The bright spots include robust declines in annual HIV infections in the Caribbean, western and central Africa. 

South Africa, Nigeria, India and Tanzania had some of the most significant reductions in the numbers of HIV infections even amidst COVID-19. 

In eastern and southern Africa, cases decreased too – but fewer people started antiretroviral (ARV) treatment, fewer HIV tests were conducted, and voluntary medical male circumcision dropped by a third.

A person dies of AIDS every minute

“Every minute of 2021, the AIDS pandemic took someone’s life,” Byanyima revealed.

Globally, 4000 people a day are still being infected with HIV and if current trends continue, 1.2 million people will be newly infected with HIV in 2025, which is three times more than the 2025 target of 370 000 new infections.

UNAIDS is particularly concerned about treatment for children living with HIV, revealing that only half (52%) have access to life-saving medicine.

While new HIV infections are still falling globally, last year the drop was only 3.6%, the smallest annual reduction since 2016. 

“These figures are about political will. Do we care about empowering and protecting our girls? Do we want to stop AIDS deaths among children? Do we put saving lives ahead of criminalization?” asked Byanyima. 

Donor funds plummet by 57%

A key concern for UNAIDS is that HIV funds from bilateral donors other than the US has plummeted by 57% over the last decade. The 2022 replenishment of the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund) in September is a focal point for HIV activists at the International AIDS Conference due to start on Friday.

Domestic HIV investments have not replaced lost international funding, mainly due to worsening economic conditions. 

“The World Bank projects that 52 countries, home to 43% of people living with HIV, will experience a significant drop in their public spending capacity through 2026,” according to the UNAIDS report.

Dr Anthony Fauci, head of the US National Institute of Allergy and Infectious Diseases, described the report as a “wake-up call”.

“There has been backsliding in the HIV response amid the COVID 19 pandemic,” said Fauci, who joined the media briefing virtually. “HIV diagnoses decreased in many countries, including in my own country. Harm reduction services to people who use drugs, and other vulnerable people have been widely disrupted. Reduced access to TB diagnosis and treatment resulted in an increase in TB deaths among persons with HIV in 2020.”

Fauci added that US President Joe Biden was seeking $7.4 billion for the US President’s Emergency Plan for AIDS Relief (PEPFAR) in 2023, noting that  PEPFAR has saved 21 million lives so far.

“Over the past two and a half years, I have seen many similarities between COVID-19 and HIV. It saddened me how hard some patient groups need to fight for recognition, how stigma, misinformation, and denialism can promote illness and death, and how slowly interventions reach vulnerable populations,” said Fauci. 

Dr John Nkengasong, speaking for the first time as head of PEPFAR, said that the HIV response was “at a crossroads”.

“If we have to bring back HIV to the fore, we have to think about political commitment, political will and political boldness to make sure that HIV AIDS is again not considered as the pandemic of the past,” said Nkengasong.

Nkengasong committed to working with UNAIDS to address the “structural determinants” of HIV, particularly “on rights and issues of discrimination and stigmatisation of key populations”. 

Dr Zipporah Ali of the NCD Alliance of Kenya.

MONTREAL – South Africa is home to the biggest community of people with HIV, but more of its citizens are now dying of diabetes than HIV and the country is grappling with how to integrate treatment for non-communicable diseases (NCDs) into HIV care.

This is something that all African countries with large communities of people are grappling with as the disease burden on the continent shifts from infectious diseases to NCDs and people with HIV get older and become more vulnerable to hypertension, diabetes, cancer and other NCDs.

A good place to start is by expanding the HIV infrastructure built by years of solid investment in clinics, hospitals, data collection and drug supply chains to include treatment for key NCDs, advised Dr Zipporah Ali, chair of the NCD Alliance of Kenya.

“But we need to look at supply chains, cost and the availability of NCD medicines,” Ali cautioned at an event hosted by the NCD Alliance (NCDA) in Montreal on Wednesday ahead of the international AIDS conference that starts on Friday.

Last year’s United Nations High-Level Meeting on HIV resolved that 90% of people with HIV should have access to NCD treatment and mental health services and this has accelerated countries’ motivation to integrate care, according to Jose Luis Castro, CEO of Vital Strategies.

Castro added that TB and HIV had been treated together for many years and could provide a model for integrated care.

Putting integration into practice

In Tanzania, six hospital sites are starting to integrate diabetes and hypertension into HIV programmes. But Dr Kaushik Ramaiya, CEO of Shree Hindu Mandal Hospital in Tanzania, stressed that, while a lot of money has been invested in HIV, the same was not true for NCDs.

“HIV drugs are free, TB drugs are free, but NCD drugs are not free and most of them have to come from out-of-pocket expenditure,” said Ramaiya. “With the HIV/AIDS and TB programme, you’re able to track each and every individual. Unfortunately, NCDs do not have that system in place, and service providers might be doing multiple accountings and lose track of your clients.”

Dr Kim Green, global program director of primary health care at the health provider, PATH, also cautioned that the supply of NCD medicines was not nearly as stable as that of ARVs in many countries. – mostly because more money had been invested in ensuring a stable supply of HIV medication.

“In Kenya, PATH is integrating NCD and HIV services so that people living with HIV are able to access medicines for hypertension and diabetes, with their ARVs. But the challenge is, the ARVs are there and they’re pretty consistently always there but the NCD meds are not,” said Green.

Dr Kiyali Ouattara, Cote d’Ivoire Director of health non-profit Jhpiego, said that his organisation had been training HIV healthcare providers in conditions like diabetes and hypertension as well as HIV.

“Instead of having the siloed HIV programme looking at HIV-positive clients only at the health facility level, we have an integrated chronic disease platform. All patients with chronic conditions are now seen by the same provider,” said Ouattara.

Minding mental health

Professor Pamela Collins from the Department of Global Health at the University of Washington made a special plea for mental health services.

“If there’s anything COVID has taught us, it’s about the importance of mental health,” said Collins.

“Around 970 million people around the world have an identifiable mental disorder in any given year, and we know that these conditions disproportionately affect the 38 million people living with HIV,” said Collins, adding that about half of mental disorders started by the age of 14 and could be disabling if not treated early.

Professor Linda-Gail Bekker

Professor Linda-Gail Bekker, Director of the Desmond Tutu Health Centre in South Africa and former chair of the International AIDS Society, said that each country would have different priorities.

“Which NCDs are we going to prioritise? That may depend from setting to setting. But undoubtedly, the emphasis now needs to be on the implementation, and how we actually put all of this together – from prevention, to demand creation through to the clinical aspects, laboratory work and the medicine supply chain.”

Alignment of global plans

Dr Meg Doherty, director of HIV at the World Health Organization (WHO), said this year was a crucial time for service integration.

“There are so many opportunities and innovations coming forward,” said Doherty, listing the new Global Fund replenishment and new PEPFAR funding models.

“As we go to the next UN high-level meeting on NCDs [in 2025], it’s critical that we bring those together because the implementation will be based upon political leadership and ensuring that there’s funding and focus.”

Starting with communities

International AIDS Society chair Dr Abeeda Kamarulzaman (left) and NCDA CEO Katie Dain.

Concluding the session, NCDA CEO Katie Dain appealed for countries to collect data about integration models that worked and were cost-effective to present to Ministers of Finance.

“Multiple speakers have spoken about the fact that the stars have aligned around the global policy frameworks, the Global Fund’s new strategy, the UNAIDS strategy, as well as COVID-19 really reinforcing the importance of integration,” said Dain.

“We absolutely need to start with communities and make this about people-centred care, and in order to do that, we need to understand patient needs. We need to be shaping policies and services with people living with HIV and NCDs.”

The NCDA and HIV organisations including UNAIDS and StopAIDS have identified 15 proposals to “achieve the best possible health outcomes” for people living with HIV and NCDs globally.

These are based on applying lessons from the struggle for HIV treatment and care  – including context-responsive, human-rights-based programmes – to build integrated universal health care.

The event was co-hosted by the Quality of Life partnership, UNAIDS, International AIDS Society, the Leona M and Harry B Helmsley Charitable Trust, and the Norwegian Agency for Development Cooperation.

Seafood and fresh food market in Wuhan, Hubei, China. Most of the earliest confirmed cases of SARS-CoV2 could be traced back to Huanan Wholesale Seafood Market, although some of the early cases never visited the market, a new study found.

The Huanan Wholesale Seafood Market in Wuhan, China, was the epicenter of the early outbreaks of SARS-CoV2, a new, peer-reviewed study asserts, following its examination of early COVID-19 cases in the region and environmental samples originating from the market. 

The study, published by Science Magazine, reinforces the theory that the emergence of SARS-COV2 occurred via the live wildlife trade in China, which was an active part of the Huanan market in late 2019 and early 2020. 

These results hone in on preprint versions of the same research, led by the University of Arizona’s Michael Worobey, that piece together spatial and biological evidence about the virus’ presence and evolution among Wuhan residents in early 2020, as well as environmental samples taken from Wuhan’s live animal markets between December 2019 and February 2020.

Higher concentration of cases around the market than expected based on population distirbution and density

The study examined the spatial density and geographical location of 155 of the 174 SARS-CoV2 cases confirmed in Hubei province in December 2019 from the 2021 World Health Organization mission report, for which locations were identified. 

While early COVID-19 cases occurred across Wuhan, the December 2019 cases were all “significantly closer” to the Huanan market than would be expected given Wuhan’s population density and distribution, the researchers found – averaging around 4-6 kilometers from the market in comparision to 16.11 kilometers for the population as a whole.  

The clusters of early cases around the market also occured at a frequency that was far higher than could be expected in comparison to the volumes and frequency of visitors to other major commercial locations in the city.

The researchers also found that both early lineages of SARS-CoV-2, dubbed A and B were “geographically associated” with the market: “Until a report in a recent preprint, only lineage B sequences had been sampled at the Huanan market,” the researchers added.

Finally, the study also found that SARS-CoV2 susceptible mammals, such as red foxes, hog badgers, and common raccoon dogs, were sold at the market in late 2019. Within the market, SARS-CoV2 environmental samples were associated with vendors selling those live mammals. 

“If SARS-CoV2 did not emerge at the Huanan market, how surprised should we be at the coincidence of finding the first cluster of a new respiratory virus at – of all places – one of a handful of markets in a city of 11 million,” said Michael Worobey of the University of Arizona and one of the authors of the study, said in a tweet on the study.  

Majority of early cases clustered near Huanan market 

Spatial patterns of COVID-19 cases in Wuhan in December 2019 and January-February 2020.  A) Locations of the 155 cases extracted from the WHO mission report. (B) Probability density contours reconstructed by a kernel density estimate (KDE) using all 155 COVID-19 cases locations from December 2019. (C) Probability density contours reconstructed using the 120 COVID-19 cases locations from December 2019 that were unlinked to the Huanan market. (D) Locations of 737 COVID-19 cases from Weibo data dating to January and February of 2020. (E) The same highest probability density contours (50% through 1%) for 737 COVID-19 case locations from Weibo data

Interestingly, even ‘unlinked’ early COVID-19 patients, those who neither worked at the market or knew someone who did, nor had not recently visited the market, resided significantly closer to the market than those patients with a direct link.  

“This is clear indication that they were infected as the virus moved from the market into the local community surrounding the market,” said Worobey in a series of tweets about the research.

This clustering of COVID-19 cases in December contrasts with the pattern of widely dispersed cases across Wuhan by early January through mid-February 2020, which was mapped by data from individuals using a COVID-19 assistance app on the Chinese social media app Weibo. 

Unlike early COVID-19 cases, by January and February many of the sick who sought help resided in a a range of highly populated areas of the city, particularly in areas with a high density of older people.  

Live mammal sales and cases linked to positive SARS-CoV2 samples 

Aggregated environmental sampling and human case data from Huanan Market. Positive samples of SARS-CoV2 (in red, map C) were found in the southwest corner, and were associated with live mammal sales and human cases.
A indicates cages with racoon dogs and birds from stalls with positive samples.

The study also points to the links between live mammal sales and positive environmental samples of SARS-CoV2 found in and around some of the animal stalls after the outbreak began. 

In addition to selling seafood, poultry, and other commodities, the Huanan market was among four markets in Wuhan reported to consistently sell a variety of live, wild-captured or farmed, mammal species in the years and months leading up to the COVID-19 pandemic. 

While there was a general slowdown of live animal sales during winter months, it was reported that animals, including raccoon dogs, were consistently available for sale up until at least November 2019, the study relates.

Five of the SARS-CoV2 positive environment samples were linked to a single stall that sold live mammals in late 2019. Objects sampled showed an association with animal sales, including a metal animal cage, carts used to transport animals, and hair/feather removers. 

This same stall was visited by one of the researchers of the paper in 2014, who had then observed live raccoon dogs housed in a cage at the same stall, on top of a cage with live birds. 

In analyzing potential regions of the market with increased density of positive samples, researchers found that ‘distance to the nearest vendor selling live mammals’ and ‘distance to the nearest human case’ were associated with the positive identification SARS-CoV-2 in environmental samples taken from the stalls. 

Live animal trade and live animal markets ‘common theme’ in virus spillover 

Based on these findings, the researchers described both the live animal trade and live animal markets a “common theme in virus spillover events”. 

“Maximum effort must now be applied to elucidate the upstream events that might have brought SARS-CoV2 into the Huanan market, culminating in the COVID-19 pandemic,” the study concludes.

“To reduce the risk of future pandemics we must understand, and then limit, the routes and opportunities for virus spillover.” 

WHO complements study, but calls for further research 

Maria Van Kerkhove, Technical Lead COVID-19

Commenting on the study at the weekly WHO press briefing, Wednesday, WHO’s technical lead on COVID-19 Dr Maria Van Kerkhove noted that some of the findings presented by Worobey and his colleagues had been noted in the most recent WHO report on the virus origins, published in June 2022 – which drew from pre-print versions of the research.

Overall, the researchers had presented “good analyses” but “without those serologic studies in the markets, at the source farms, without tracing those animals back, it still leaves some open questions,” Van KerKhove said.  

“Unfortunately, it’s not enough. We need more studies to be done in China and elsewhere,” she said, so as to make a definitive determination of the SARS-CoV2 origins. “The goal is not just to figure out how this pandemic began, it’s to learn how we better prepare for the future.”   

Added Dr Mike Ryan, Executive Director of WHO’s Health Emergencies Programme: “It’s important for us to remember that all hypotheses remain on the table. But we’re very pleased to see this kind of work being done, which advances us and advances our common understanding of the origins of this disease.”

Image Credits: Arend Kuester/Flickr, Worobey et al, 26 Science, July 2022, Worobey et al (2022) .

Men receiving doses of monkeypox vaccine.

About 10% of people with Monkeypox require hospitalization and children are at the highest risk of severe disease, says WHO. Meanwhile, there are only about 1 million doses of the EMA and US FDA-approved MVA-BN vaccine readily available today across the globe – but that vaccine is also untested against monkeypox at large scale.

The world would need about 180,000 to 360,000 Monkeypox vaccine doses to immunize people who may have recently been exposed to monkeypox, said WHO officials on Wednesday. That was the first ballpark estimate of vaccine need to be made by the global public health agency, since the public health emergency was declared on Saturday, July 26. 

If, however, countries eventually opted for a strategy of vaccinating all of those people and groups at risk – the demand could swell to some 5-10 million doses of the two-dose vaccine, said WHO’s Tim Nguyen, speaking at a WHO press conference on Wednesday. 

Tim Nguyen, Unit Head
High Impact Events Preparedness

Currently, there are about 1 -1.4 million available doses worldwide of the MVA-BN vaccine, the only one approved by the European Medicines Agency and the US Food and Drug Administration, both WHO and other pharma sources have said. 

That vaccine is manufactured in Europe as Imvanax and JYNNEOS in the United States by the Danish pharma firm, Bavarian Nordic, the sole producer of the vaccine.  

Estimates based on potential number of contacts with 18,000 people infected now 

WHO Emergency Dashboard for Monkeypox as of 27 July 2022

Nguyen said that the estimates were made on the basis that there are right now some 18,000 cases reported globally, and “if you look at a post-exposure strategy and extrapolate the global number of cases, by 10-20 contacts each, you get to 180,000-360,000 vaccine doses. 

“As for pre-exposure prophylaxis, among what countries define as high risk groups, this could account for something between 5-10 million doses of the vaccine. These are preliminary ballpark figures and we are looking at further modeling studies.” 

He added that in terms of pre-exposure strategies, “when it comes to the supply, we know that there is not enough in fill-and-finish form. So the key is what are their [Bavarian Nordic’s] plans for gearing up on fill and finish capacity.” 

He added that WHO has already “received offers” from other manufacturers to help the Danish firm to “scale up the fill and finish” – and passed those onto the manufacturer.  

Said WHO’s Chief Scientist, Soumya Swaminathan, “We are in discussions with the manufacturers to get an idea of availability of doses.. Many of them have already been committed to countries, we would like to explore the possibility of a donation from countries that do have doses, to put them in a stockpile.”

Soumya Swaminathan, WHO Chief Scientist

Reached for comment, a Bavarian Nordic spokesperson did not comment directly on the WHO’s appeals. However, he told Health Policy Watch that “We are scaling up our production of the MVA-BN vaccine based on customer demand.” 

The spokesperson added that the company had already “made agreements with a contract manufacturer for filling of vaccines as per our announcement on July 15.”

Other approved smallpox vaccines are ACAM2000 and LC-16, the latter produced by the Japanese firm KM Biologics- but neither have been authorized for use against monkeypox. 

WHO calls for men who have sex with men to reduce number of partners  

Tedros Adhanom Ghebreyesus, WHO Director General

 In light of the vaccine supply constraints as well as outstanding questions about the vaccine, non-pharmaceutical measures such as contact tracing and self-isolation of infected people remain very important, the WHO officials said. 

In an unusual appeal, WHO’s Director General Dr Tedros Adhanom Ghebreyesus also called upon the LGBTI community, and particularly men who have sex with men, to reduce their number of sexual partners, in order to get the virus under control. 

“This is an outbreak that can be stopped if countries, communities, and individuals themselves take the risk seriously, and take the steps needed to stop transmission and protect vulnerable groups,” he said. 

“The best way to do that is to reduce the risk of exposure. That means making safe choices for yourself. And for men who have sex with men: this includes for the moment, reducing your number of sexual partners. Reconsider sex with new partners and exchange contact details with any new partners to enable follow up if needed,” he stressed. 

Virus can be transmitted via hugging, kissing, and infected surfaces 

The WHO official noted that while 98% of cases are among men who have sex with men, the virus can be transmitted to household members, through hugging and kissing, and contact with infected towels and betting. 

“Anyone can get monkeypox, so we must take action to reduce the risk of transmission to other vulnerable groups, including women, children, and immunocompromised groups,” he said. 

WHO, meanwhile, has called upon countries that have already purchased the vaccine and are beginning to roll out the vaccine to collect information on its efficacy – in light of the dearth of information that exists on the mass deployment of the vaccine in a real life setting. 

Most cases reported in WHO’s European Region 

Currently, some 70 percent of the more than 18,000 Monkeypox cases reported have been in WHO’s European Region, while about 25 percent have been reported in the Americas, mostly North America. Some 365 cases have been confirmed in Africa, where the disease is endemic, but that excludes more than 2,000 suspected cases for which laboratory tests were unavailable, in light of the dearth of capacity. In other WHO regions, reported cases has been negligible although that, too, may be due to lack of test capacity and stigmatization that makes infected people reluctant to seek care at all. 

However, while some countries already are beginning to roll out the vaccine, it’s still unclear how well the vaccine works. 

Symptoms in children are the most acute – can lead to dehydration, encephalitis, potential blindness

monkeypox
Positive monkeypox test.

While there have only been 5 deaths reported, the 10% rate of hospitalization – often for pain management – reflects the seriousness of the disease. And while 98% of cases seen today are among men who have sex with men, those children who have been affected have also been the hardest hit, officials said. 

“There is a preponderance of children, pregnant women and immune-compromised persons amongst those who do develop severe disease,” said Rosamund Lewis, WHO’s monkeypox lead.

Both current and classic forms of monkeypox appear on the neck and lymph nodes and can become significantly enlarged making it difficult to swallow, she said. 

“So, for example if the rash is very extensive, there can be fluid loss. Because these lymph nodes can become significantly enlarged, making it difficult to swallow – which can also contribute to dehydration.  There can be severe pain in the mouth and throat, which contributes to difficulty eating.

“Taking care of the rash is important for children who develop significant rashes,” she added. “And of course monkeypox can also affect the other mucosal surfaces, especially including the eyes.”

Rosamund Lewis, Technical lead for monkeypox

“And certainly in the African setting, we’ve seen a number of people who develop scarring over the cornea become blind due to monkeypox because of the lesions that appear in the eyes and on the cornea. So there are a number of other things that can happen. 

“We are starting to see a few cases of encephalitis which is inflammation of the brain. This has been reported in the past.”

There also could be “consequences” for a woman that becomes infected during  pregnancy, added Lewis concluding: “so these are people that are vulnerable… either because of their age, their immune status, and children are still building their immunity, and others may have their immunity compromised, whether through pregnancy, untreated HIV or chemotherapy or other immuno-suppressive treatments.” 

-Stefan Anderson in Brussels helped contribute to the research of this story.

Image Credits: The Hill/Twitter , WHO , TRT World Now/Twitter .

hiv awareness

MONTREAL – A fourth person has been “cured” of HIV after receiving a stem cell transplant for leukaemia at the City of Hope Hospital in the US.

The 66-year-old man, who was diagnosed with HIV in 1988, has been in remission 17 months after stopping antiretroviral therapy (ART) following a stem cell transplant for leukaemia.

The City of Hope patient received the transplant nearly three and a half years ago, and is older than the three previous patients with HIV who have gone into remission after receiving stem cell treatment for a blood cancer.

Like Timothy Ray Brown, the “Berlin patient” and Adam Castillejo, the “London patient”, the City of Hope patient developed a blood cancer and received stem cells from a donor who had a rare gene mutation (CCR5 Delta 32 on the CD4 cells) making them nearly immune to HIV. 

Earlier this year, a woman in the US was also reported to have been in remission from HIV for over a year following a stem cell transplant using cells from an umbilical cord of a donor, an unrelated newborn child, with the same genetic mutation. Cord blood is used to supply blood stem cells for transplants for patients unable to find matched adult donors. Like the others, she had been living with HIV for a number of years and needed treatment for leukaemia.

The City of Hope patient was the oldest patient to undergo a transplant with HIV and leukaemia and go into remission from both conditions. 

“We were thrilled to let him know that his HIV is in remission and he no longer needs to take antiretroviral therapy that he had been on for over 30 years,” said Dr Jana Dickter, City of Hope associate clinical professor in the Division of Infectious Diseases, who presented the data at an AIDS 2022 press conference on Wednesday. 

“He saw many of his friends die from AIDS in the early days of the disease and faced so much stigma when he was diagnosed with HIV in 1988. But now, he can celebrate this medical milestone.” 

“The City of Hope patient’s case, if the right donor can be identified, may open up the opportunity for more older patients living with HIV and blood cancers to receive a stem cell transplant and go into remission for both diseases,” Dickter added. 

“When I was diagnosed with HIV in 1988, like many others, I thought it was a death sentence,” the man, who wishes not to be identified, said. “I never thought I would live to see the day that I no longer have HIV. City of Hope made that possible, and I am beyond grateful.” 

Under the care of City of Hope hematologist Dr Ahmed Aribi, the patient received three different therapies to get him into remission before receiving a transplant. Most patients achieve remission after one therapy. The remission is necessary because a transplant is an intensive procedure that can cause serious complications. 

City of Hope is a leader in treating patients with blood cancers, and has pioneered the use of gene-modified blood stem cell transplants to test whether stem cells can be engineered to be resistant to HIV infection. 

Leveraging their expertise in cellular immunotherapy, City of Hope scientists have also developed chimeric antigen receptor (CAR) T cells that can target and kill HIV-infected cells and control HIV in preclinical research. 

City of Hope CAR T scientist working in a lab.

They are working to start a clinical trial using CAR T therapy, which has the potential to provide HIV patients with a lifelong viral suppression without ART. 

“The City of Hope patient is another major advancement. It demonstrates that research and clinical care developed and led at City of Hope are changing the meaning of an HIV diagnosis for patients across the United States and the world,” said Dr John Zaia, director of City of Hope’s Center for Gene Therapy.

Under the care of City of Hope hematologist Dr Ahmed Aribi, the patient received three different therapies to get him into remission before receiving a transplant. Most patients achieve remission after one therapy. The remission is necessary because a transplant is an intensive procedure that can cause serious complications. The patient did not experience serious medical issues after transplant. 

“This patient had a high risk for relapsing from acute myeloid leukaemia, making his remission even more remarkable,” Aribi said.

Image Credits: NIAID/Flickr, City of Hope.

Sally Agallo Kwenda

Sally Agallo Kwenda’s first baby only lived for two days. She fell pregnant again almost immediately but her second son was born prematurely and died soon afterwards. Shortly after his death, she learnt that she had AIDS. 

Some years later, after struggling with depression and grief, Kwenda was diagnosed with stage two cervical cancer – something to which people with HIV are far more susceptible, but which is often diagnosed late in Africa and other low-income countries because of the sharp disconnect between diagnosis and treatment of HIV/AIDs, and non-communicable diseases (NCDs) – at primary health care level.

In late May, the World Health Organization approved a roadmap to accelerate the battle against NCDs, which now claim the heaviest mortality in low- and middle-income countries ill-equipped to prevent, diagnose and treat chronic lung and heart conditions, hypertension, diabetes and cancer.  The Roadmap aims to put countries back on track to reach the SDG target 3.4 of reducing premature deaths from NCDs by one-third by 2030 -following severe setbacks created by the COVID pandemic.

But key to that aim, says the NCD Alliance and other advocates, is better integration of NCD prevention and treatment with well-established primary health care services for HIV and other infectious diseases.

“What I went through with cancer I would not wish on my worst enemy,” said Kwenda in a film produced recently by the NCD Alliance (NCDA).

Kwenda has become a vocal advocate for the integration of HIV and NCD treatment and care and was due to address an NCD Alliance event on the issue on Wednesday ahead of the International AIDS Conference in Montreal, which opens on Friday.

But, like many African delegates have reported, she was unable to get a visa to travel to Canada and will advocate for integrated care via online links to the conference.

“I would be very happy that, before I die, I would see the integration of care happen,” says Kwenda, who runs support groups for people living with HIV in Kenya.

After all that she has gone through, Kwenda says that she is not a survivor but a “warrior” for patients’ rights.

Africa’s emerging NCD problem  

NCDs now cause 15 million premature deaths of people between the ages of 30 and 70 each year, 85% of them in low- and middle-income countries.

“In most of sub-Saharan Africa, the biggest causes of death or illness have been due to infectious diseases: malaria, tuberculosis, diarrhoeal diseases in children and HIV,” says Professor Gerald Yonga, a Ugandan cardiologist who represents civil society at the World Health Organization (WHO) Working group on NCDs.

“But NCDs are an emerging problem, increasing a lot over the last 20 years such that now NCDs cause about 30 to 35% of mortality and 50% of hospitalisation and illness.”

Yonga explains that people with HIV have a greater chance of getting an NCD, and that “cervical cancer is as high as six times more likely to occur in people living with HIV”.

Professor Gerald Yonga

HIV is also a risk factor for more serious illness and mortality with COVID-19.

In 2021, United Nations member states adopted a Political Declaration on HIV and AIDS that pledged to ensure that 90% of people living with HIV have access to NCD prevention and care services, including for mental health, by 2025. 

The NCD Alliance says that the global declaration “offers an unprecedented opportunity” to build on multi-sectoral, rights-based and people-centred approaches of the HIV response and to use HIV service delivery platforms to integrate other health services, like “NCD prevention, screening, diagnosis, treatment, care, rehabilitation and palliative care”. 

“There is strong support from in-country stakeholders to pursue greater integration of NCD and HIV services as part of universal health care,” the NCDA adds.

The NCDA and HIV organisations including UNAIDS and StopAIDS have identified 15 proposals to “achieve the best possible health outcomes” for people living with HIV and NCDs globally.

These are based on applying lessons from the struggle for HIV treatment and care  – including context-responsive, human-rights-based programmes – to build integrated universal health care.

The NCDA will use the Montreal conference to build support for these proposals, including calling more more resources to address NCDs.

 

Dr Hans Kluge, WHO Regional Director for Europe.

WHO’s Regional Director for Europe, Hans Kluge, has asked the 53 countries in the WHO region to “act with urgency” in halting the Monkeypox emergency that has hit the region hardest  – noting that “vaccines alone won’t end the outbreak”. 

Kluge’s statement Tuesday followed Saturday’s declaration by WHO of a global public health emergency over the spread of the virus, which has now infected over 18,000 people in 78 countries, according to Tuesday’s data. That is not including several thousand more suspected cases in areas of central and west Africa where the animal-borne disease is endemic, but testing capacity is low.  

Among those, some 81 children under the age of 17 have been reported with infections around the world, said WHO’s Rosamund Lewis, speaking at another press briefing in Geneva. 

“We do still believe that this outbreak of monkeypox can be stopped, with the right strategies in the right groups,” Lewis said at a briefing. “But time is going by and we all need to pull together.”

Europe has been the epicenter of the recent outbreak, with 37 countries affected so far and the public health risk in the region described as “high”, Kluge said: 

“From 13 May through 22 July, close to 12 000 probable or confirmed cases, mostly in men who have sex with men, have been reported in the Region, of whom 8% were hospitalized with, fortunately, no deaths to date.”  WHO’s dashboard put the number of cases in the European region at 13,000.  

WHO monkeypox dashboard as of 26 July. Dark blue shows highest concentrations of confirmed cases since global reporting began in May, 2022. Not including over 2,000 suspected cases also reported in the African Region’s endemic zones, since the beginning of 2022.

Remove health care barriers, confront stigmatization, limit sexual partners 

Kluge called upon health providers to “remove any and all barriers” for patients to access care, as well as battle stigmatization.

“Any barrier, however large or small, will act to prevent patients from coming forward,” Kluge stressed, adding that healthcare providers also need to watch out for “atypical” presentations of the virus, marked by skin lesions, that can mimic others disease as well as removing “any judgment or stigma from the patient pathway – the lessons of HIV/AIDS must not be forgotten. 

Limit sexual partners, for time being at least

But he also called upon men who have sex with men – who are in the highest risk groups to “consider limiting your sexual partners and interactions at this time.” 

“This may be a tough message, but exercising caution can safeguard you and your wider community. While vaccination may be available to some people with higher exposure risks, it is not a silver bullet, and we still ask you to take steps to lower that risk for the time being,” said Kluge in the statement. 

Public health authorities – boost national capacities & collaborate regionally  

monkeypox
Monkeypox skin lesions

Meanwhile, Kluge called upon national public health authorities to “significantly and swiftly boost national capacities for monkeypox surveillance, investigation, diagnostics and contact tracing to help identify and track every possible case. Many cases are likely going undetected, further fuelling the outbreak.  

He also admonished policymakers to “Genuinely work together with at-risk groups and communities and their leaders – including organizers of community events such as summertime Pride festivities – to develop and disseminate crucial messages aimed at curtailing transmission and encouraging uptake of health services.”

There is a “burning need for cross-regional collaboration” he added, calling upon countries to  “ensure vaccines and antivirals reach those who need them the most, as opposed to stockpiling supplies and “going it alone” – actions that are only detrimental to the wider public good, as we’ve seen during the response to COVID-19.” 

Testing capacity low in central Africa where several thousand cases suspected

But there are major holes in testing capacity – in the very countries that have traditionally been endemic for the disease. 

For instance, in the entire WHO African region, where 12 central and eastern African countries are endemic for the disease, only 328 cases have been confirmed by WHO -although Africa is the only region having reported deaths from Monkeypox – five in total.  

In countries such as the Democratic Republic of the Congo, DRC, it over 2000 suspected cases have been reported since the start of the year WHO’s Afrian Region has reported.  But only 163 cases have been confirmed.  

That is largely a reflection of the severe limitation of testing in Africa, and other low- and middle-income regions, which require more WHO support, Lewis said. The WHO global dashboard does not include suspected cases.

 

Traditionally, the clade of monkeypox circulating in DRC and elsewhere in Central Africa has been much more deadly than west African clade, which had seen an upswing in cases in countries such as Nigeria in recent years. A variant of the milder clade was likely transmitted to via international travel to Europe, where person-to-person transmission became more intense and more sustained, triggering the current outbreak.   

Meanwhile, the Americas is the second most heavily-affected region, with some 4,600 cases, with the United States and Brazil most heavily affected. Only 61 cases and 25 have been reported in the WHO’s Western Pacific and Eastern Mediterranean regions respectively. WHO’s South East Asian Regional Office has reported only 5 cases. 

Some 16.4 million vaccines available in bulk, but need to be “filled and finished”

Rosamund Lewis Technical lead for monkeypox, WHO Health Emergencies Programme

As for vaccines, WHO officials have said that some 16.4 million doses of the most effective vaccines  (MVA-BN) are currently available in bulk.  However only about 1 million have been processed into the “fill and finish” of vials ready for delivery. 

Lewis said that the WHO was working with Member States and the European Union on strategies for releasing monkeypox vaccines – along with the creation of a global coordination mechanism. A dashboard with regularly updated data on cases has also been created online.

In combatting monkeypox, mass vaccination is not required, she said, but rather targeted vaccination of health workers, men at high risk because they have had multiple sex partners, and family members of other infected people.  WHO also has recommended post-exposure vaccination of contacts.

Targeted vaccination strategies recommended

Historically smallpox vaccines have been very effective against monkeypox. However, the so-called ‘third’ generation vaccines have remain somewhat untested due to their lack of widespread deployment, and “because they are more attenuated, it is possible they are less effective” against the monkeypox virus, she said. 

The third generation vaccine MVA-BN vaccine, produced by Bavarian Nordic, is the vaccine currently is the most demand. It is regarded as the safest because the vaccinia virus injected does not replicate inside the body. 

MVA-BN is being produced in Denmark and the United States, under the trade names of JYNNEOS and Imvanex, with about 16.4 million doses available in bulk but only about 1 million doses readily available for distribution in a “fill and finish” state, according to WHO’s Tim Nguyen, speaking at Saturday’s press briefing. 

Japan produces another third generation smallpox/monkeypox vaccine, LC-16 but it has not offered to share it beyond its national stockpiles.   A large global stockpile exists of the second generation ACAM2000® vaccine, which was seen to be highly effective against monkeypox when used in smallpox eradication campaigns that ended in the 1970s.  But it has more side effects and is therefore not in high demand presently. 

Lewis called upon countries and manufacturers with vaccines or therapeutics manufacturing capacity to “increase production, and increased availability and … to work with WHO to ensure that diagnostics, vaccines, therapeutics and other necessary supplies are made available based on public health needs, human rights, solidarity and at reasonable cost to countries that most need them to stop the monkeypox outbreak.”  

Image Credits: ET Times Lifestyle/Twitter, WHO.

hepatitis e
Medicins Sans Frontieres and the South Sudan Ministry of Health vaccinate people in Bentiu, the largest internally displaced persons camp in South Sudan.

In a global first – over 25,000 people in South Sudan have been vaccinated in the world’s first mass vaccination campaign to contain an outbreak of hepatitis E, a disease especially fatal for pregnant women.

The outbreak occurred in Bentiu, the largest internally displaced persons camp in South Sudan. Outbreaks of hepatitis E have been seen there since 2015, due to appalling living conditions, including inadequate water, sanitation, and hygiene. 

The most recent outbreak has seen 759 patients with confirmed hepatitis E, 17 of whom have died. 

Hepatitis E is the most common cause of acute viral hepatitis, causing approximately 20 million infections and 44,000 deaths every year. It is transmitted through faecal contamination of food and water. Large scale outbreaks typically occur in mass displacement camps, where water and sanitation are inadequate. 

While hepatitis E has a fatality rate of up to 25% among pregnant women, as well as an increased risk of spontaneous abortions and stillbirths, there is no specific treatment for the disease, so preventing its spread is critical.  

“The fight against hepatitis E has been long and frustrating,” said Dr Monica Rull, Medical Director, Médecins Sans Frontières (MSF). 

First time vaccine has been used in a public health emergency

In response to the outbreak, Médecins Sans Frontières (MSF) and South Sudan’s Ministry of Health jointly carried out the first two rounds of a hepatitis E vaccination campaign in Bentiu in March and April 2022. 

Around 25,000 people, including pregnant women, received Hecolin, the only available hepatitis E vaccine, developed and tested in China, where it is licensed and used primarily to vaccinate travellers. While the World Health Organization has recommended that it be used in outbreak response since 2015, the campaign in Bentiu was the first time the vaccine had been used at scale, in response to a public health emergency.

A third and final round of vaccinations will be conducted in October 2022. South Sudan’s Ministry of Health and MSF are monitoring and reporting on the results of the vaccination campaign.

Hepatitis E vaccination campaign considered a success

Hepatitis E factors in South Sudan’s high maternal death toll.

Both MSF and the South Sudan Ministry of Health have praised the ‘successful’ response to the vaccination campaign, saying it can be a model replicated in future outbreaks. 

“Given the successful implementation and the community’s enthusiastic response in the first two rounds, this innovative vaccination campaign can serve as an example and be replicated in similar settings managing hepatitis E outbreaks,” said Dr John Rumunu, Director General for Preventive Health Services, South Sudan Ministry of Health. 

“I hope the vaccine will help reduce infections and deaths from hepatitis E in Bentiu and beyond.”

“Over the last two decades, MSF has been responding to hepatitis E outbreaks in a wide range of displacement camps, trying to control the disease in challenging conditions and seeing the devastating impact on extremely vulnerable communities,” said Rull. 

“With the experience of this vaccination campaign, we hope to change the way we tackle hepatitis E in the future.”

WHO has called the campaign a “significant milestone” in the fight against hepatitis E. Melanie Marti, a WHO Medical Officer for the Department of Immunization, Vaccines & Biologicals, said, “It is the first time a vaccine has been used to combat the effects of this potentially devastating disease.”

Image Credits: MSF Innovation/Twitter , Stephen Rynkiewicz/Twitter .