A delegate at the 24th International AIDS Conference.

MONTREAL – People with mental health conditions are more likely to get HIV, while people with HIV often struggle with depression and other mental health issues – but few countries offer psychosocial support as part of their HIV services.

“As a result of systemic inequalities, mental health issues keep coming up and you have to deal with them head-on,” said Lucy Njenga from Positive Young Women Voices, who works with women and girls with HIV in some of the poorest communities in Kenya.

“Violence against women and girls and poor socio-economic conditions are the key challenges ,” Njenga told International AIDS Conference delegates.

Her organisation has a counsellor available but addressing poverty through cash transfers that enabled girls to remain in school and food parcels “that made them feel that they are loved” have also proved important.

“Mental health is a necessary, essential part of any HIV programme,” Dr Don Operario from Brown University’s School of Public Health in the US, told delegates.

“Mental health and HIV aren’t two co-occurring, siloed epidemics, but operate interactively, exacerbating each other’s negative effects in the most marginalised populations,” he added.

“We’re seeing a consistently high prevalence of depression, anxiety, suicidality, post-traumatic stress disorder and substance abuse in men who have sex with men (MSM), and substantially higher relative to heterosexual peers,” said Operario, who is one of the authors of a Lancet-published series on mental health iand HIV.

South Africa’s mission to broaden HIV services

Aside from mental health, few HIV programmes include screening and treatment for a host of other non-communicable diseases (NCDs) that prey on people with HIV – including diabetes, hypertension and cervical cancer. 

In South Africa, which has the biggest population of people living with HIV in the world, more people are now dying of diabetes than AIDS. People with HIV are living longer thanks to antiretroviral treatment, and having to confront a range of NCDs.

South Africa’s health minister, Dr Joe Phaahla, told Health Policy Watch that his mission in Montreal is to persuade donors to allow his country the flexibility to build screening for diabetes and hypertension into HIV programmes as a start.

“Of course, HIV and TB are still important because they are still killing people, but we want donors to accept that the HIV resources we get for training health workers, for laboratories and so on, will be expanded to include diabetes and hypertension screening and diagnosis,” said Phaahla.

“The cancers are more complicated, but diabetes and hypertension are our priorities.”

Phaahla’s targets for persuasion are the Global Fund to Fight AIDS, TB and Malaria and the US President’s Emergency Plan for AIDS Relief  (PEPFAR). 

Earlier, a presentation at the conference that involved spatial mapping data of people’s health needs in rural KwaZulu-Natal, a province in South Africa, found that people living with HIV also had a high burden of diabetes and hypertension.

The Global Fund’s replenishment conference is being held in September and much of the focus of the conference involves discussion about how money raised should be spent.

Marijke Wijnroks from the Global Fund’s secretariat conceded that the fund had only made “small scale” investments in mental health so far, citing Zimbabwe as one example of a country that is trying to address this in its HIV services – but that there is a global growing impetus for integrated services.

Last year, the United Nations Political Declaration on HIV/AIDS pledged to ensure that 90% of people living with, or at risk of, HIV should be able to get essential health services, including mental health and other NCD care by 2025. 

Wijnroks said that the fund had not been “explicit enough” about the importance of integrated care in the past although the evidence of its impact was “clear”.

However, the fund’s new 2023-2028 funding strategy adopted in December includes integrated people-centred primary health care with “explicit language” about including NCD diagnosis and treatment in HIV services, she said.

“It’s really about looking at a person and trying to provide support to that person in a comprehensive way because people don’t live in siloes. They have a whole range of issues that they need support with,” said Wijnroks. 

Integration makes financial sense too. Modelling by the non-profit United for Global Mental Health estimates that reducing new HIV infections could be at least 10% faster if mental health services and psychosocial support are included as a core part of HIV services – and up to 20% faster if included in tuberculosis care.

24th International AIDS Conference (AIDS 2022), Montreal, Canada.

NCD Alliance appeals to Global Fund

Despite the growing realisation that NCDs have to be factored into HIV services, the AIDS conference offered few successful models – and only two sessions focused on NCDs and HIV.

In an open letter to the Global Fund issued shortly before the AIDS conference, the NCD Alliance (NCDA) called on the fund to “prioritize the inclusion of NCD interventions” in its  2023-2028 strategy.

This should include financial and technical support for HIV and NCD prevention and care at the primary healthcare level, said the NCDA.

It also called for people living with the fund’s target diseases – HIV, TB and malaria – and NCDs to be properly consulted about their “ full health care needs to improve quality of life and physical and financial barriers to access”, and for proper data to be collected about needs and gaps in health coverage.

Image Credits: Marcus Rose/IAS, Jordi Ruiz Cirera/IAS.

monkeypox
MVA-BN, marketed under the trade name IMVAMUNE, is the world’s only vaccine marketed against Monkeypox.

The manufacturer of the world’s only vaccine approved for monkeypox, Bavarian Nordic, closed its European vaccine production plant this spring and won’t reopen again until late 2022 – leading to a global monkeypox vaccine shortage, Health Policy Watch has learned.

With only 16.4 million doses of the MVA-BN vaccine available worldwide, it is unclear how the company plans to meet rising demand for its monkeypox vaccine following the global health emergency of international concern recently declared by the World Health Organisation.

With no new doses expected to leave the facility until early 2023, donations from the few high-income countries that have stockpiled the vaccine, notably the United States, will be crucial to the world’s ability to respond to the outbreak.

Without a new licensing deal to speed up production of their vaccine, Bavarian Nordic risks catalysing a preventable repeat of the inequities seen in the early global response to the Covid pandemic.

Vaccine equity – no better today than before the COVID pandemic?  

Currently, the Danish-based company holds the patent to the only European Medicines Agency and US Food and Drug Agency approved monkeypox vaccine, the technology upon which any vaccination campaign the world might launch to combat the expanding epidemic of cases.  

The lack of clarity, and resulting confusion over the actual state of play in terms of Bavarian Nordic’s own production capacity, and the distribution of available vaccines amongst high-risk countries, is a sharp reminder that the world may be no better prepared today to roll out vaccines rationally and equitably than it was before the COVID pandemic. 

With the rights to the manufacture and distribution of the vaccine solely in Bavarian Nordic’s hands, and more than a dozen countries inquiring about doses, it is the US government that will be in possession of, or contracted to receive, the overwhelming majority of MVA-BN doses due to be delivered in 2022 – roughly adding up to about 14.4 million doses.

The US Defence Department, through the Biomedical Advanced Research and Development Authority (BARDA), financed key elements of the vaccine’s development with contracts amounting to nearly $2 billion between 2003 and 2020, a review of those contracts by Health Policy Watch shows. 

The net result means that, either via donations, or by persuasion of Bavarian Nordic to scale up its production, Washington, once more, could be called upon to take the lead in ensuring equitable access to monkeypox treatments.  That is unless Bavarian Nordic signs new licensing deals with other manufacturers to produce the vaccine.  So far, however, the company’s only recent deals were for the fill-and-finish of 2.5 million doses of already-produced monkeypox, with the US government, along with a recently-announced license deal was with the Chinese firm, Nuance Pharma, to support the development and commercialization in Asia of the company’s MVA-BN® RSV vaccine for prevention of Respiratory Syncytial Virus, which can afflict babies and older people in particular.   

European plant shuttered – production won’t restart until 2023 

Bavarian Nordic’s European vaccine production line, key to its generation of new volumes of the MVA-BN monkeypox vaccine, was closed this spring and will not be reopened until the third quarter of 2022, according to a 9 May investor report. The plant was shuttered prior to the emergence of the global health emergency presented by monkeypox in order to create new production lines for vaccines against rabies and tick-borne encephalitis, Rabipur and Encepur, recently acquired by Bavarian Nordic from GSK.

The investor report states flatly that, “the bulk facility is currently shut down and will not reopen until third quarter of 2022, thus restricting manufacturing capacity in 2022”.

Bavarian Nordic investor report describes the plant closure which aims to diversity its European production lines.

Once re-opened, the company will only begin producing new volumes of the vaccine in early 2023, global health sources in Geneva told Health Policy Watch. 

Company so far silent on offers to help with  ‘fill and finish’ 

Of the roughly 16 million doses of MVA-BN vaccine said to be available now, most – about 15 million are still in bulk form, according to statements this week by WHO.   

Most of the available 1-1.4 million finished and delivered doses are held in the strategic stockpile of the US, which heavily financed the development of the vaccine, according to the global health forecasting firm Airfinity. 

MVA-BN orders in the US, according data provided by Airfinity.

Virtually all of the 15 million remaining doses, stored in bulk formulation, are already promised to a tiny handful of high-income customers – mostly the United States. 

MVA-BN orders are already promised to high-income countries such as the US, Canada, and the EU.

According to the Airfinity data, as of 20 July 2022, the US had another 13 million doses on order for 2022,  with another 2 million doses spread between Canada, the United Kingdom the European Union, Germany and another “undisclosed European country”. 

Nearly 30 million more doses delivered in earlier years to the US have already expired. 

Company has just one fill-and-finish deal with a US Contractor 

JYNNEOS smallpox vaccine produced by Bavarian Nordic, approved by the FDA for use against monkeypox.

In an exchange with Health Policy Watch, a source at Bavarian Nordic pointed to the recent conclusion of a deal with the US government to fill-and-finish 2.5 million more doses from bulk supplies available, with a US-based firm.

But despite the current closure of the company’s European manufacturing line, there are no current plans to outsource or out-license the bulk manufacturing of MVA-BN, the source indicated.

The company is scaling up production of the MVA-BN vaccine, based on “customer demand” and has “planned our production to satisfy the demand for our vaccine in both the short and the medium term,” the source added, without referring to impacts of the plant closure.  

In a statement hailing the agreement on fill-and finish with the US, Bavarian Nordic CEO Paul Chaplin stated, “expanding our manufacturing capabilities into the United States allows Bavarian Nordic to deliver more monkeypox vaccines to meet the immediate worldwide demand for JYNNEOS”. 

However, without more external licensing agreements, it is unclear how Bavarian Nordic indeed expects to meet increasing demand. 

‘Not enough’ in fill and finish form

Tim Nguyen, Unit Head
High Impact Events Preparedness

Company executives have so far remained silent in the face of offers by the WHO, as well as individual pharma firms, to support more production scale-up, or more rapid “fill-and-finish” of the 15 million vaccines available right now in bulk at a critical point for the global response to the spread of monkeypox. 

Speaking at a press briefing on Wednesday, WHO’s Tim Nguyen noted:

“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.

South Africa’s Aspen Pharmacare is one such firm that came forward recently with a public offer to support the fill and finish of monkeypox vaccines. 

“At the onset of the COVID-19 pandemic, Aspen was able to swiftly respond by making its extensive sterile formulation, fill and finish capabilities available in response to immediate surging demands”, Aspen said in a press release on Thursday, adding “it would be in a position to step in and replicate this for Monkeypox should global circumstances and demands require this.”

Paradoxically, Aspen’s COVID-19 facility, whose opening was touted last year by WHO officials as a “transformative moment” in the mission to drive down stark vaccine inequalities, is also at risk of closure due to lack of demand for its version of the Johnson & Johnson vaccine “Aspenovax”, which was a flagship product of Africa’s aspirations to localize more vaccine capacity on the continent.  So a contract to fill-and-finish Monkeypox could be a perfect match – if only the suitor was interested. 

Approached by Health Policy Watch, Bavarian Nordic’s spokesperson Thomas Duschek declined to provide further details of the company’s vaccine production and distribution plans – or whether the company would negotiate with Gavi to sell Monkeypox vaccines in bulk for low- and middle-income countries. 

World needs between 180,000 and 10 million doses – WHO  

Speaking at Wednesday’s WHO press briefing, Tim Nguyen, the Unit Chief of the High Impact Events Preparedness divison at the WHO, estimated that the world would need some 180,000-360,000 doses based on an extrapolation of the 18,000 global cases confirmed at the time to immediately begin vaccinating the contacts of those already infected, estimated to be at 10 to 20 people per infected person.

Following Nguyen’s model, the current number of vaccines required would be between 217,550 and 435,550. If a strategy of vaccinating high risk groups was adopted, however, demand would stand at up to 10 million doses, Nguyen said. 

As the vaccine is a two-dose jab, however taking several weeks to take effect, WHO officials have admitted that even if vaccine campaigns were immediately and systematically launched, the burden of the infection will only continue to grow. 

And indeed it already has. From the estimated baseline of 18,000 cases reported by WHO on Wednesday, nearly 21,256 cases had been reported today, according to the WHO’s health emergency dashboard. 

Monkeypox cases as of 29 July, as reported by Global Health

Meanwhile, according to data from the global research consortium, Global Health, co-sponsored by Harvard and Oxford University, the caseload of confirmed and suspected cases totals 23,454 cases across 77 countries. 

Another COVID replay: WHO and Gavi urge rich countries to donate vaccines

While vaccine demands are spread among those countries now reporting cases, only a handful of nations, and primarily the United States, hold the keys to available supplies that could be used right away to stem the pandemic tide.  

This has left the WHO and its associates asking for vaccine donations, another striking replay of the early days of the COVID vaccine rollout. 

“We urge countries with stockpiles – or supplies on order – to be generous and flexible in releasing doses to countries with cases that do not have access to ensure equality,”  a spokesperson for the Vaccine Alliance (GAVI) told Health Policy Watch. 

HO’s Chief Scientist, Soumya Swaminathan also speaking at last Wednesday’s WHO briefing, echoed that, saying: “we are in discussions with the manufacturers to get an idea of availability of doses. Many of them have already been committed to countries, so we would like to explore the possibility of a donation from countries that do have doses, to put them in a stockpile.”

But the United States also announced last week that it will begin deploying some 800,000 doses of its available MVA-BN stock to vaccinate at risk groups at home.  That leaves little in its strategic stockpile for donations – until at least the 2.5 million doses of fill-and-finish are delivered.  

Asked for more details about the WHO’s “discussions” with the pharma firm, a WHO spokesperson suggested that Health Policy Watch, “speak to Bavarian Nordic.”

Replay of COVID Vaccine playbook?  Global health officials tread carefully  

Gavi’s CEO Seth Berkley

Despite the emerging tensions between vaccine demand and supply, leading global health officials have so far tread gently in their comments about the Danish vaccine company, perhaps due to the world’s dependence on this single company’s policies to get the pandemic under control.

“I look at Bavarian Nordic, and it’s a good company,” GAVI CEO Seth Berkley noted in a press briefing Thursday. 

But, he added, Bavarian Nordic “doesn’t have a large fill finish production facility, so it may be that if four doses are needed, then moving towards a fill and finishing approach as Aspen or the few other manufacturers have offered would be a way to move forward”. 

Anne Simon, Unit Chief of the EU’s Health Emergency and Preparedness Response Authority (HERA), told Health Policy Watch, “the European Commission, notably through HERA and the European Medicines Agency, stand ready to support Bavarian Nordic to scale up vaccine production as is needed”.

The Global Fund was more blunt: “The global COVID-19 response demonstrated structural global health inequities which left low and middle-income countries exposed to harmful vaccine nationalism”, a spokesperson for the Global Fund told Health Policy Watch, “we must acknowledge the very real global double standards, and we must strive to do better”. 

Other Vaccines: Unsuitable or Unavailable

The smallpox vaccine supply is still limited and concentrated in only a few countries.

In theory, there are two other vaccines available against smallpox – and thus potentially effective against monkeypox. But neither are licensed for monkeypox as such. 

First is the LC16, manufactured by Japanese pharmaceutical KM Biologics, the only second or third-generation smallpox vaccine to be licensed for use in children by the WHO. Officials at the WHO, however, have noted that Japan views the vaccine as a national asset, and the country has no plans to share its stockpiles. 

When KM Biologics was asked about plans for production scaling and prospects of working with WHO or GAVI to provide vaccines for distribution in low and middle-income countries, the company told Health Policy Watch: “we are afraid we cannot be of help in the matters described in your email”. 

The world also possesses around 100 million doses of the older generation ACAM2000 vaccine that contributed to the eradication of smallpox, but experts deem the risk of adverse effects too high to deploy unless absolutely necessary.

“The available vaccines are not routinely used because of the risk of adverse events”, notes the New England Journal of Medicine in a 2018 study, “they would not be used in the general population unless Variola Virus (VARV) exposure were either known or suspected”.  

“This is a global challenge”, GAVI CEO Seth Berkley explained at a press conference on Thursday, “if you have rare diseases, or small producers for disease, there’s not enough attraction to have them produced by many different manufacturers”. 

‘Threats Anywhere Can Become Threats Everywhere’

US signs launched mass vaccination of at-risk groups with 800,000 doses of its available stock of monkeypox vaccine

“The unanticipated emergence of monkeypox outside of Africa is a perfect case study of how threats anywhere can become threats everywhere”, Oxford Professor of Emerging Infections and Global Health Peter Hornby said on behalf of the European Clinical Research Alliance for Infectious Diseases in a press release responding to the monkeypox outbreak, “it exemplifies the need to work as a global community to identify and counter all infectious disease problems, wherever they occur, and whomever they affect”.  

“It is frustrating to see the same pattern repeating itself again”, Oxford Professor Piero Olliaro and Emmanuel Nakoune of Institut Pasteur,  leaders of a key study in the Central African Republic on the efficacy of antiviral agent tecovirimat in treating monkeypox, wrote in the British Medical Journal during the early stages of the high-income country outbreak.

“Attention is only paid when certain diseases hit high-income countries, exemplifying our collective failure to properly address “epidemic preparedness” and “global health,” though they are nominally on top of our agenda with the COVID-19 pandemic”. 

Paradoxically, while the MVA-BN vaccine is registered in Europe, where the recent monkeypox outbreak first became apparent and the heaviest burden has now occurred, it is not even registered in the 9 to 12 central and West African countries where the disease is endemic. 

Several thousand suspected cases have been reported by WHO in front-line countries where monkeypox is endemic this year, including cases of the deadlier Monkeypox Clade 1, that circulates in central Africa, and has a 10% mortality rate. To date, no deaths have been reported from the variant affecting high-income countries.

This lack of regulatory approval can also create barriers to access, even if supplies are adequate, Oxford professor and former senior WHO official Piero Olliaro explained in an interview with Health Policy Watch. 

“There are huge asymmetries: both treatments and vaccines are registered in high-income countries, but not in endemic low-income countries,” said Olliaro, “Ebola medicines are in exactly the same situation, with two drugs registered in the US for treating Ebola, but not registered or available in the endemic countries, not even in the Democratic Republic of Congo where the studies were done”. 

But this is just one issue among a whole spectrum of public health and health system challenges that are faced in rolling out new vaccines or drugs.

Fixing the market failure – but not the public health failure 

On supply issues, a series of public sector incentives have succeeded in stimulating R&D in some historically neglected diseases, including SARS-COV2, Ebola and Monkeypox, Olliaro notes.  

“Essentially, there are pull and push mechanisms in place, which have been set up and have succeeded in fixing the market failure, at least for some diseases,” he said. 

“The whole market for neglected diseases suffers, by default, from market failure,” Olliaro explained, “massive packages of incentives to develop certain products, including the subsidizing and de-risking of development for pharmaceuticals dealing with these niche diseases.

The mechanism referred to by Olliaro is the US Government’s Priority Review Voucher programme, a sort of pharma ‘prize’ that` allows the developer  of a new drug or vaccine for qualifying “tropical diseases” to obtain more rapid FDA review of another upcoming product, or to trade off the voucher to another firm for their use on an upcoming drug, earning benefits of millions or tens of millions of dollars.

“These mechanisms fix the market failure, but they do not fix the public health failure, which is the availability of these drugs in the countries where these diseases are endemic,” Olliaro explained, adding, “this system has been developed to deal with a rich country problem.”

“Like for COVID, through a combination of having a single producer monopoly, suddenly increasing demand, and hoarding, then if we need vaccines in Africa or any other low and middle income countries, there is none, unless someone is prepared to donate.” 

R&D Contracts of Bavarian Nordic by the US

Since 2003, the total value of R&D contracts awarded to Bavarian Nordic by the United States government sits north of 1.9 billion USD, according to US public records.

And yet, the world still faces a shortage of this same vaccine.

Part one of a Health Policy Watch series on global monkeypox preparedness. 

–updated on 1 August 2022 with correction in description of Bavarian Nordic’s MVA-BN® RSV vaccine as a candidate for prevention of respiratory syncytial virus. 

Image Credits: FIH Partners , Bavarian Nordic, Barda , Global Health , The Hill/Twitter , USA Spending .

24th International AIDS Conference (AIDS 2022), Montreal, Canada. 
Opening Session
.

MONTREAL – Activists took over the stage at the opening of the International AIDS conference in Montreal on Friday morning to protest Canada’s denial of visas to hundreds of delegates, primarily from Africa, and the inequality and lack of funding that is driving new HIV infections.

South African activist Vuyiseka Dubula, former head of the Treatment Action Campaign, told the conference that activists needed to speak on behalf of those who were denied access to the conference:

“TB [HIV co-]infections are increasing. Our governments do very little to address the opportunistic infection cryptococcal meningitis.  Young women are used in clinical trials to test [HIV] products but when these products are ready, they are not accessible,” said Dubula, as the crowd chanted “Another minute, another death, AIDS is not over.”

Adeeba Kamarulzaman, president of the International AIDS Society and co-chair of this year’s conference, said that she was “deeply upset” about the visa denials that were a result of “global inequality and systemic racism”.

IAS re-evaluating future conference venues

“IAS is re-evaluating to ensure that future conferences remain inclusive events. Those most affected must be part of the conversation,” said Kamarulzaman.

Canada’s Minister of International Development, Harjit Sajjan, withdrew from speaking at the opening, apparently after hearing about the planned protest.

Expressing her disappointment at the Canadian official’s no-show, UNAIDS executive director Winnie Byanyima paid tribute to the protestors, saying that no progress had ever been made in HIV without activism.

“Every two minutes an adolescent girl or young woman acquires HIV, too often from a sexual act that was forced on her,” Byanyima told the conference.

“There were 650,000 AIDS-related deaths last year, a life lost every minute despite effective HIV treatment and tools to prevent, detect and treat opportunistic infections,” Byanyima said. 

“What we need to do is not a mystery. We know it from what we’ve repeatedly seen succeed across different contexts: shared science, strong services and social solidarity. We can end AIDS by 2030. But the curve will not bend itself. We have to pull it down, together, ” Byanyima said. 

Earlier in the week, the UNAIDS director herself was almost refused permission to board her flight from Geneva to Montreal, making her flight only after she placed a number of high-level calls.  “Unjust and racist” she declared on Twitter: 

Donor retreat

South African AIDS activist Vuyiseka Dubula at AIDS Conference in Montreal, Canada.

The conference takes place at a difficult time in the battle against HIV, with a substantial slowdown in progress against the pandemic – in part because of COVID-19.

HIV funds from bilateral donors other than the US plummeted by 57% over the last decade, according to the UNAIDS Global AIDS update, In Danger.

Addressing the cooling of global donor support for HIV, Professor Linda-Gail Bekker said that the disease was still uppermost in the minds of the 28 million people on ARV treatment and those at risk of infection.

“We lose sleep over the 10 million people not on treatment. We have not reached our destination yet. It’s time to get back on the bus,” said Bekker, an infectious disease expert and Director of the Desmond Tutu Health Centre in South Africa.

“The time is running out. If we do not re-engage, and apply our all the science we will backslide and lose all the considerable investment in HIV of the past 40 years,” she warned.

Over Five Million Babies born HIV-free 

Dr John Nkengasong, former head of Africa CDC and the newly-appointed head of the US President’s Emergency Plan for AIDS Relief (PEPFAR), said that 5.5 million babies have been born HIV-free as a result of PEPFAR.

“This is an incredible milestone for our programme and for the next generation,” Nkengasong said, but warned that without the replenishment of the “war chest” to fight HIV, it would be hard to keep hope alive.

This September, US President Joe Biden will host the Global Fund’s Seventh Replenishment with the aim of raising at least $18 billion to fund the next three years of the Global Fund partnership’s activities.

“Success in raising those funds is a matter of life and death. With $18 billion we could save at least 20 million lives over just three years and cut the annual death toll from HIV, TB and malaria by almost two-thirds,” said Global Fund executive director Peter Sands.

“We would also make everyone in the world safer from future infectious disease threats, by strengthening health and community systems and making them more inclusive and resilient.”

More than 9,500 in-person and nearly 2,000 virtual participants are registered to attend the fully hybrid AIDS 2022, the 24th International AIDS Conference, which ends on 2 August.

Image Credits: Jordi Ruiz Cirera/IAS, Steve Forrest/Workers’ Photos/IAS.

Meningitis A vaccination in Chad.

Two years of the COVID-19 pandemic led to a cumulative 5% decline in basic vaccine coverage and disrupted routine immunizations globally from 2020 – 2021, reports a new analysis of the state of routine immunizations across 57 lower-income countries.

The analysis, by Gavi, the Vaccine Alliance, indicates that signs of recovery are beginning to emerge in some countries, such as Pakistan, although in other countries such as the Democratic Republic of Congo, the setbacks persist.  

“Even though more than half of countries have increased or maintained their campaigns, we can still see that we are not getting ourselves out of the woods when it comes to the pandemic,” declared Thabani Maphosa, Gavi Managing Director of Country Programmes, at a press briefing just before the report’s release.

The analysis used data from the recently published WHO/UNICEF Estimates of National Immunization Coverage (WUENIC) to examine the state of immunization in 57 lower-income countries supported by Gavi for bulk procurement and rollout of basic vaccines, mostly to children. 

Basic vaccine coverage in lower-income countries dropped by one percentage to 77% in 2021, after a four-percentage point fall in 2020, the first year of the pandemic, the report found. Basic vaccine coverage is defined as receiving three doses of a diphtheria, tetanus, pertussis shot (DTP3). 

The number of zero-dose children – those who have not received a single routine vaccine shot – rose for the second year running to 12.5 million. 

“Hiding behind these figures is a human tragedy on an enormous scale” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance.  “Millions of children have missed out on life saving vaccines, leaving them vulnerable to some of the world’s deadliest diseases.”

‘Country specific impacts’ leading to decline found in larger countries

coverage
Heat map for change in routine immunization in lower-income countries, 2020 – 2021. Countries with further decline in coverage are indicated in red, such as DRC and Mozambique.

The overall decline since 2019 has been primarily driven by larger countries, including the DRC and India. DRC, after a strong growth trajectory in previous years, fell from vaccinating 73% of children in 2019 to 65% in 2021. India dropped from a high coverage level of 91% to 81%.

The Democratic People’s Republic of Korea (North Korea), Myanmar, and Mozambique also saw further declines in coverage in 2021, in addition to those of 2020. 

“This analysis represents a very sobering assessment of the impact the pandemic continues to have on essential routine immunization,” said Anuradha Gupta, Deputy CEO of Gavi.

Many of these declines in coverage can be attributed to what Gavi called ‘country specific impacts’, including natural disasters that struck Mozambique and attacks on health care workers amid conflict in DRC.  

“While health systems have certainly been placed under great stress [due to the pandemic], other factors, for example, health worker strikes, political crises, or internal conflict are all having major country specific impact,” said Berkley, in a press briefing on Thursday. 

Earlier this month the World Health Organization and UNICEF had also reported that 18 million of the 25 million unvaccinated children who did not receive a single DTP3 dose in 2021 were located in low- and middle-income countries such as India, Nigeria, Indonesia, the Philippines, and others. 

Signs of recovery: one-third of countries increased coverage

Polio vaccination campaign with COVID-19 prevention measures

On the brighter side, however, one-third, or 19 of the 57 countries included in the analysis, increased vaccine coverage in 2021. Two-thirds of African countries brought coverage back up to pre-pandemic levels or close to that marker. 

Chad and Niger both increased coverage across the pandemic period from 2019 – 2021, reducing the number of zero dose children by 16% and 20% respectively. Pakistan saw strong recovery in 2021, reducing the number of zero-dose children by over 400,000, bringing numbers back to pre-pandemic levels. 

Interestingly, however, other fragile and conflict-affected countries saw a lower decline in vaccine coverage than other countries, with Gavi maintaining coverage at 67% over the course of 2021. 

Heroic efforts to administer both routine immunization shots and COVID vaccines 

A health worker administers COVID-19 vaccinations in Islamabad, Pakistan.

Notably, including COVID-19 vaccinations, lower-income countries administered more vaccines in 2021 than any year in history. 

“Gavi-supported countries not only administered routine vaccines to 65 million children, but they did so alongside frankly heroic efforts to administer more than 2 billion COVID-19 vaccines,” Berkley said.  He asserted, however, that it was not the additional burden of COVID vaccinations, per se, that kept routine coverage rates lower in some countries but rather a “more complex” array of factors, related to civil and political strife, in particular.

Gavi will now be working with lower-income countries towards further recovery – focusing on restoring coverage to pre-pandemic levels, with a laser focus on zero dose children.

The Vaccine Alliance had launched a new $100 million initiative, the Zero-Dose Immunization Programme (ZIP) last month in partnership with the International Rescue Committee (IRC) and World Vision (WV) to reach unvaccinated children specifically in the Horn of Africa and Sahel regions. 

Gavi will also be dedicating a further $2 billion towards strengthening health systems and immunization delivery, with half of that dedicated to reaching zero dose children and missed communities. 

The challenges are evermore greater due to population increases, Maphosa said, which mean that there are 1.2 million more children annually that need to be vaccinated.

“We have our challenges, but I’m confident that we can build routine immunization back even stronger especially on the backbone of what we have been able to achieve in our pandemic response,” said Maphosa. 

Image Credits: Gavi, Gavi, UNICEF/Pakistan , Gavi/2021/Asad Zaidi.

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 .