africa
Africa recorded the world’s highest gain in life expectancy in the new WHO report.

Africa recorded the world’s highest gain in healthy life expectancy over the past decade. But the lack of sustainable finance for health systems is a major threat to the gains recorded.

Africa recorded the world’s highest growth in healthy life expectancy—or the number of years an individual is in a good state of health—between 2000 and 2019. Healthy life expectancy increased on average 10 years per person, the World Health Organization (WHO) assessment reported.

The Tracking Universal Health Coverage in the WHO African Region 2022 report shows that healthy life expectancy—or the number of years an individual is in a good state of health—increased to 56 years in 2019, compared to 46 in 2000. While still well below the global average of 64, over the same period global healthy life expectancy increased by only five years.  

At a press briefing launching the report Thursday, WHO officials and other invited experts attributed the gains to increased universal health coverage (UHC) on the continent. But sustainable financing remains a major challenge for the 47 sub-Saharan countries that belong to WHO’s Africa Region – with all but seven of the 47 WHO African region countries depending on outside donors for more than 50% of the costs of health services delivery.  

Many WHO Afro countries rely on outside funding for health care costs.

At the same time, increased provision of essential health services, including for reproductive, maternal, newborn and child health were among the factors to which the gains of the past decade could be attributed. Other contributors are progress in the fight against infectious diseases notably rapid scale-up of HIV, tuberculosis, and malaria control measures from 2005. 

“The sharp rise in healthy life expectancy during the past two decades is a testament to the region’s drive for improved health and well-being of the population,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. 

“It means that more people are living healthier, longer lives, with fewer threats of infectious diseases and with better access to care and disease prevention services,” she said. “But the progress must not stall. Unless countries enhance measures against the threat of cancer and other noncommunicable diseases, the health gains could be jeopardized.”  

Most governments in Africa fund less than 50% of their national health budgets 

Progress in healthy life expectancy could also be undermined by the impact of the COVID-19 pandemic unless robust catch-up measures are instituted, WHO and other experts at the briefing warned. Insofar as the report’s data ends at 2019 – the COVID years were not captured by the data presented. 

On average, for instance, African countries reported greater disruptions across essential services compared with other regions, according to a 2021 WHO survey.  

Efforts have been made to restore essential services affected by the pandemic. However, to ensure long-term sustainability, it is crucial for governments to step up self-financing of services – weaning their countries away from heavy reliance on international donors.  

Most governments in Africa fund less than 50% of their national health budgets, the report notes.. Only Algeria, Botswana, Cabo Verde, Eswatini, Gabon, Seychelles and South Africa fund more than 50% of their national health budgets. 

“COVID-19 has shown how investing in health is critical to a country’s security. The better Africa can cope with pandemics and other health threats, the more our people and economies thrive. I urge governments to invest in health and be ready to tackle head on the next pathogen to come bearing down on us,” said Dr Moeti.      

UHC coverage increased in the region an average of 22 points.

According to the report, UHC coverage across the region increased by an average of 22 points on a scale of 0 to 100, rising to 46 in 2019 up from from 24 in 2000, along the lines of a Service Coverage Index (SCI). The scale measures some 14 UHC indicators including those for reproduction, material and child health, infectious diseases, and non-communicable diseases.  Even so, only four countries had a UHC index between 56 and 75, with the highest values in southern and northern African subregions respectively. 

“This progress, though significant, falls short of meeting the SDG 3.8.1 global target of a minimum of 80% coverage of essential health services by 2030,” the report notes.

Inequality across many countries remains a crucial determinant of the level of health service coverage.

Botswana provides good practice 

Moses Keetile, of Botswana’s Ministry of Health and Wellness Botswana

Botswana is one of the African countries making appreciable progress in public funding for healthcare, the report says, with almost 80% of its health spending in 2019 going towards the government’s domestic programs.

Speaking at the briefing, Moses Keetile, of Botswana’s Ministry of Health and Wellness Botswana, told Health Policy Watch the country’s ability to sustain its gains on UHC  largely hinges on ensuring that health ranks high on the priority list of politicians.

“Allocation of national resources is very important,” he said. “To what extent is health given a priority? What is it that we are spending our resources on? Is it on health, physical education, or is it in the military. So it’s very important that we speak to our politicians for that political will and ownership.” 

He also described reliance on external funds as unsustainable for Botswana and other African countries. Countries have to implement innovative ways of creating revenue and funding for health care delivery, he said, stressing that the private sector is also an important partner in advancing UHC. 

“The Botswana UHC experience is still predominantly government but that is not the most ideal situation. It is important to have all the necessary sectors, including the private sector, to be part of it,” he concluded.

The exception, rather than the norm

The overall change in out-of-pocket expenditure between 2000 and 2019.

Botswana remains the exception, rather than the norm, however, the report says.  

Government coverage of catastrophic and out-of-pocket expenditures through health insurance or free health care systems is one of the measures key to improving health coverage. Health expenditure is considered “not catastrophic” when families spend less than 10% of their annual income on it, irrespective of their poverty level. 

Yet over the past 20 years out-of-pocket spending stagnated or increased in 15 countries out of the African Region’s 46 countries, the report finds. And out- of-pocket expenditure increased by more than 90% in at least three countries.

Conversely, a total of 15 countries are faring above the regional average, in terms of combined service coverage and financial risk protection. 

Good performance among that latter group of countries is not entirely income driven, the report says. Rwanda, Malawi and Mozambique are low-income countries among the 15 good performers on that scale of measurement.  Angola, Nigeria, Mauritania, Côte d’Ivoire, Cameroon and Comoros are middle-income countries with low performance in both service coverage and financial risk protection.

Lack of investment in health threatens economic and national security

Professor Muhammad Ali Pate, of the Harvard T. H. Chan School of Public Health

Professor Muhammad Ali Pate,of the Harvard T. H. Chan School of Public Health agreed with Keetile. He noted that public and private investments in health in Africa can also be pitched to policymakers as contributing to economic growth.

“There is scope to harness private capital to invest in laboratories in hospitals. But with a public mission protected, every citizen should be guaranteed basic access to quality health care. The public health function should be publicly financed, and tax financing is a key part of that,” he told Health Policy Watch. 

According to Pate, enhancing the private sector’s role should not, however, absolve African governments from domestically investing in health services, including through robust tax collection.  

“What we have seen with the pandemic is a lack of investment in health that threatens economic and national security,” he said. “Finance ministers and economic planning ministers have a vested interest to ensure the public health outbreaks are contained, and that equipment and the test kits are available and produced locally so they also contribute to economic growth.”

Dr Lindiwe Makubalo, Assistant Director, WHO Regional Office for Africa

Dr Lindiwe Makubalo, assistant director of WHO’s Regional Office for Africa, also highlighted the importance of multi-party partnerships. She noted that the new report provides guidance towards properly building health systems and ensuring health security in Africa.

“We elaborate the different components of what needs to be done. At the end of the day, I think it’s the value of understanding the value of health and health security, and appreciating all of the wider sector approach that is really what is going to be important,” she told Health Policy Watch.

Image Credits: World , WHO Afro.

Breastfeed
Woman breastfeeding her child.

Nearly $575 million in global economic and human capital is lost every year due to insufficient government promotion of, and support for, breastfeeding, according to data from the latest report on  The Cost of Not Breastfeeding. 

The 2022 report, released for World Breastfeeding Week (1 August – 7 August) finds that these losses are the result of increased child and maternal mortality and other healthcare costs, and account for an average 0.7% of a nation’s gross national income. 

However, increasing country-level support for breastfeeding could save not only 515,000 lives each year, it could also save the global economy $1.5 billion each day, according to the report by the Alive and Thrive initiative and Nutrition International. 

This support would be in line with the World Health Organization’s recommendations, which include initiating breastfeeding within the first hour of birth, exclusive breastfeeding for the first six months, and continuing breastfeeding alongside complementary feeding from six months to two years and beyond.

“Breastfeeding is the primary building block of a healthy food system and one of the best ways to give a child the right start in life,” said Joel Spicer, President and CEO, Nutrition International. 

“But women around the world aren’t getting the support, resources, and protection they need to begin breastfeeding soon enough and sustain it for the recommended period. Governments need to make breastfeeding a top public policy priority, and with the Cost of Not Breastfeeding Tool, policymakers can see the real-world benefits of doing just that.”

The revamped report includes tools like a new user-friendly dashboard and data from 180 countries. In addition to mortality rates and healthcare costs, the report offers new calculations for the impact of not breastfeeding on childhood obesity, IQ losses and education. 

Inadequate breastfeeding has negative impacts for children ‘down the line’ 

Investment in breastfeeding can improve health outcomes later in life.

Inadequate rates of exclusive and continued breastfeeding can lead to increased healthcare costs down the line, as well as decreased cognitive ability for children, impacting their education and future income potential. 

The lack of support may have to do with the increased promotion for breast milk substitutes, which were found by WHO to undermine breastfeeding through use of digital ads and other forms of advertisement. 

For families, not breastfeeding also increases the cost of living, as household income is redirected to formula or other breastmilk substitutes. 

The Global Breastfeeding Collective recommends seven policy actions that national governments can implement to support and promote breastfeeding, including enacting paid leave and workplace breastfeeding practices, strengthening the links between health facilities and communities, and implementing the International Code of Marketing of Breastmilk Substitutes.

The Code is meant to stop the “aggressive and inappropriate marketing of breast milk substitutes.”

“Increasing breastfeeding rates through supportive actions and policies can help to save the lives of mothers and children, and protect economies from preventable losses,” said Sandra Remancus, Director, Alive & Thrive.

Image Credits: WHO, UNICEF.

food crisis
Millions of lives are at risk due to an unprecedented food crisis in the greater Horn of Africa.

In light of an unprecedented food crisis in the Horn of Africa, the World Health Organization has launched a $123.7 million funding appeal for urgently needed supplies to treat severe malnutrition and related health conditions. 

Driven by conflict, changes in climate and the COVID-19 pandemic, this largely arid Eastern African region of some 2 million square kilometres spanning the Indian Ocean to the sources of the Nile, traditionally home to pastoralists and subsistence farmers living off of livestock and harvests of rain-fed crops, has become a hunger hotspot with disastrous consequences for the health and lives of its people.

“Hunger is a direct threat to the health and survival of millions of people in the greater Horn of Africa, but it also weakens the body’s defenses and opens the door to disease,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, in a statement. 

Four consecutive failed rainy seasons have decimated locally grown crops such as maize, wheat and caused abnormally high numbers of livestock deaths, in a crisis considered to be one of the worst climate change-related disasters in over 40 years. 

In addition, Russia’s invasion of Ukraine has disrupted supply chains and sent prices of imported wheat, cooking oil, and other cooking staples soaring, further worsening the crisis.

Prior to war, Russia and Ukraine supplied 40% of Africa’s grain

Children across the Horn of Africa are at risk for acute malnutrition. 

Prior to the war, Russia and Ukraine supplied Africa with more than 40% of the continent’s grain. Somalia alone used to import more than 92% of its wheat from these two countries, but supply lines have since been blocked. 

Now over 80 million people in the 7 countries spanning the region – Djibouti, Ethiopia, Kenya, Somalia, South Sudan, Sudan and Uganda — are estimated to be food insecure, as a result of this food crisis. 

Upwards of 37.5 million people are classified by WHO as being in a Phase 3 food crisis, a stage where people have to sell their possessions in order to feed themselves and their families, and where malnutrition is rife.

Additionally, more than 1.7 million children across parts of Somalia, Ethiopia, and Kenya urgently need treatment for acute malnutrition, according to UNICEF. 

“WHO is looking to the international community to support our work on the ground responding to this dual threat, providing treatment for malnourished people, and defending them against infectious diseases,” Tedros said. 

“Hunger is a direct threat to the health and survival of millions of people in the greater Horn of Africa, but it also weakens the body’s defenses and opens the door to disease,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. 

“WHO is looking to the international community to support our work on the ground responding to this dual threat, providing treatment for malnourished people, and defending them against infectious diseases.”

The funds raised from the appeal will go towards urgent measures to protect lives in the region, including increasing countries’ capacity to detect and respond to disease outbreaks, procuring and ensuring the supply of life-saving medicines and equipment, identifying and filling gaps in health care provisions, and providing treatment to sick and severely malnourished children. 

Situation continues to worsen

With the start of the autumn rainy season expected to be delayed once more, thus delaying the planting of new crops, the food insecurity in the Horn of Africa is expected to continue to grow through the autumn. 

In Somalia alone, about 7.1 million people — almost half the population — will confront crisis-level food insecurity or worse until at least September and 213,000 of them face catastrophic hunger and starvation, according to the Integrated Food Security Classification (IPC), an intergovernmental consortium including UNICEF, the World Food Programme and the UN Food and Agriculture Organization, that tracks and ranks food insecurity hotspots.  

“Ensuring people have enough to eat is central. Ensuring that they have safe water is central. But in situations like these, access to basic health services is also central,” said Dr Michael Ryan, Executive Director of WHO’s Health Emergencies Programme. 

“Services like therapeutic feeding programmes, primary health care, immunization, safe deliveries and mother and child services can be the difference between life and death for those caught up in these awful circumstances.”

 Violence, disease outbreaks, and displacement result from food crisis  

The food crisis has resulted in avoidable death of children and women in childbirth.

The food crisis has also resulted in increased violence, outbreaks of disease, and mass displacement. 

​​There are already reports of avoidable deaths among children and women in childbirth. Gender-based violence is on the rise. There are outbreaks of measles in 6 of the 7 countries, against a background of low vaccination coverage, in addition to the mass displacement of people and relaxation of social distancing norms. 

Countries are also simultaneously fighting cholera and meningitis outbreaks as hygiene conditions have deteriorated, with clean water becoming scarce as people migrate.

The region already has an estimated 4.2 million refugees and asylum seekers, with this number expected to increase as more people are forced to leave their homes in search of food, water, and pasture for their animals. When on the road, communities find it harder to access health care, a service already in short supply following years of underinvestment and conflict.

WHO has already released US$ 16.5 million from its Contingency Fund for Emergencies to ensure people have access to health services, to treat sick children with severe malnutrition and to prevent, detect, and respond to infectious disease outbreaks.

The global health agency has also set up a hub in Nairobi to coordinate delivery of medical supplies and other WHO support to areas of the region in the throes of conflict, humanitarian and climate-related crises.

Image Credits: Mohammed Omer Mukhier/Twitter , WHO/Twitter , HBNonline/Twitter .

Twelve African nations have joined with the United Nations and other international organizations in forming a new alliance that will work to prevent new infant HIV infections and to ensure no child living with HIV is denied treatment by the end of the decade.

Proponents of the new Global Alliance for Ending AIDS in Children by 2030 announced its creation on Tuesday at an International AIDS Conference wrapping up in Montreal, Canada.

The first phase includes Angola, Cameroon, Côte d’Ivoire, Democratic Republic of the Congo, Kenya, Mozambique, Nigeria, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe.

Three UN agencies — UNAIDS, UNICEF and the World Health Organization (WHO) — are behind it along with the Global Network of People Living with HIV (GNP+), the Global Fund to Fight AIDS, Tuberculosis and Malaria and the U.S. President’s Emergency Plan For AIDS Relief (PEPFAR).

At the conference, UNAIDS revealed that progress against HIV slowed down during the COVID-19 pandemic as donors pull back, countries test and treat fewer people and miss key targets.

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

Nearly Half of All Children with HIV Lack Life-Saving Treatment

Just 52% of all children living with HIV are receiving treatment that can save their lives, far behind the 76% of all adults that are receiving antiretrovirals. That’s according to data released in the UNAIDS Global AIDS Update 2022.

Because of that the alliance says over the next eight years it will focus on closing the treatment gap and breastfeeding adolescent girls and women living with HIV and optimizing continuity of treatment, and on preventing and detecting new HIV infections among pregnant and breastfeeding adolescent girls and women.

Its other priorities include ensuring there is accessible testing, optimized treatment, and comprehensive care for infants, children, and adolescents exposed to and living with HIV, and that the rights, gender equality, and social and structural barriers that hinder access to services are adequately addressed.

“The wide gap in treatment coverage between children and adults is an outrage. Through this alliance, we will channel that outrage into action,” UNAIDS Executive Director Winnie Byanyima said.

“By bringing together new improved medicines, new political commitment, and the determined activism of communities, we can be the generation who end AIDS in children,” said Byanyima. We can win this, but we can only win together.”

Aids in children prompts call for community leadership

AIDS in Children
A mother from Lesotho, Limpho Nteko, who serves as a spokesperson for the female-led mothers2mothers program (Credit: m2m.org)

A mother from Lesotho, Limpho Nteko, who serves as a spokesperson for the female-led mothers2mothers programme that works to combat HIV pregnancy transmission, told the conference that community leadership is an important factor.

“To succeed, we need a healthy, informed generation of young people who feel free to talk about HIV, and to get the services and support they need to protect themselves and their children from HIV,” said Nteko, who found out she had HIV while pregnant at age 21 with her first child.

WHO’s Director-General Dr Tedros Adhanom Gheberyesus said no child should be born with or grow up with HIV, and no child with HIV should go without treatment.

“The fact that only half of children with HIV receive antiretrovirals is a scandal, and a stain on our collective conscience,” he said. “The Global Alliance to End AIDS in Children is an opportunity to renew our commitment to children and their families to unite, to speak and to act with purpose and in solidarity with all mothers, children and adolescents.”

Image Credits: Emmanuel Museruka/DNDi, m2m.org.

Demonstrators at the 24th International AIDS Conference in Montreal, Canada.

MONTREAL – HIV is one of the most studied diseases of all time and an arsenal of treatment and prevention tools have been amassed over the past 40 years – the latest being an antiretroviral (ARV) injection taken every eight weeks that can prevent 99% of infections.

But HIV is still spreading – primarily amongst people who have been deemed criminals or invisible by their governments.

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

Adolescent girls in sub-Saharan Africa, many of whom are infected during coerced sex, are another vulnerable group.

“We have the tools. We know what we are supposed to do. But we need a people-centred approach to meet people where they are,” Professor Linda-Gail Bekker, head of the Desmond Tutu Health Centre and infectious diseases expert, told the International AIDS Conference in Montreal.

Global battles at UN forums

Yet growing political conservatism means that, despite the scientific tools, many governments operate according to prejudice rather than science, ensuring that HIV continues to flourish in the crevices of restrictive societies that chose not to recognise behaviours they find unacceptable.

These conservative forces are increasingly raising their voices at international forums to undermine proven methods to address HIV.

During the United Nations High-Level Meeting on AIDS in June last year, Russia refused to support the final political declaration as it opposed references to “rights”, the decriminalisation of sex work, and harm reduction in the context of the battle against HIV/AIDS.

HIV infections in Russia re rising, driven by people who inject drugs, and less than a quarter of Russians living with HIV know their status.

This June, the World Health Assembly – the highest decision-making body of the World Health Organization (WHO) – was delayed for hours as countries fought over terms in the body’s new strategy on HIV, hepatitis B and sexually transmitted infections. 

Member states primarily from North Africa and the Middle Eastern led the assault on the guide for including “sexual orientation”, “men who have sex with men” and “comprehensive sexuality education” (CSE) for school children.

Eventually, an almost unprecedented vote was held and a watered-down version of the strategy was passed, but around 120 countries either abstained or were absent.

HIV infections rose in the Middle East and North Africa last year, along with Eastern Europe, Central Asia and Latin America, according to the UNAIDS latest report, In Danger.

Human rights backlash

UNAIDS executive director Winnie Byanyima acknowledged at the launch of the report that “today we see a huge backlash against certain human rights that some were won many years ago, for example, sexual and reproductive health and rights”. 

“We’re seeing countries that are pushing back against the human rights of LGBTQ people and we’re seeing further enforcement of punitive laws against people who inject drugs, sex workers, and LGBTQ people,” Byanyima said in response to a Health Policy Watch question.

“The international community must stand together on human rights. Human rights are an important part of creating the enabling environment for everyone to access what science has to offer.”

UNAIDS is supporting “key populations” in many countries to “have a voice to defend their human rights”, she added. 

“This is a critical part of HIV and indeed, in the United Nations system, UNAIDS will continue to advance international legislation to strengthen those rights but it is a battleground today.”

Rights-based approach saves lives

Groundbreaking research published in the BMJ last year by Dr Matthew Kavanagh has quantified the effect of official discrimination, concluding that countries where same-sex acts, sex work and drug use were criminalised “had approximately 18%–24% worse outcomes” in preventing HIV infections.

“One of the most powerful lessons from the history of the fight against HIV is that success in confronting such a formidable disease cannot be achieved through biomedical interventions alone,” said Peter Sands, Executive Director of the Global Fund. 

“We must also confront the injustices that make some people especially vulnerable to the disease and unable to access the health services they need. The same is true for TB, malaria, and other diseases, including COVID-19.”

Since 2017, the Global Fund has provided financial and technical support in 20 countries to address “stigma, discrimination, criminalisation and other human rights-related obstacles” that undermine progress against HIV, tuberculosis (TB), and malaria.

A progress report released by the Global Fund on Sunday showed that this initiative, called Breaking Down Barriers, is slowly starting to make progress.

One of the strategies of the initiative is to empower the groups facing discrimination to take legal action to protect and advance their rights in the 20 countries – Benin, Botswana, Cameroon, Côte d’Ivoire, Democratic Republic of the Congo, Ghana, Honduras, Indonesia, Jamaica, Kenya, Kyrgyzstan, Mozambique, Nepal, Philippines, Senegal, Sierra Leone, South Africa, Tunisia, Uganda and Ukraine.

Successes include human rights training for health care workers and police as well as legal literacy and “know your rights” campaigns for key populations. 

Jamaica has trained over 1,000 police officers in protecting the human rights of people living with HIV and key populations, while Sierra Leone has explained its needle and syringe exchange programme to key government officials and police officers.

In Kenya, community activists have been trained to document human rights violations of key populations.

The Viva+ Project in Mozambique has implemented community dialogues and radio programmes to address stigma and discrimination in 11 provinces and 63 districts. 

Botswana has held community dialogues with traditional chiefs to discuss men who have sex with men and transgender people.

A partnership of civil society organisations led by the Global Network of People with HIV (GNP+) launched a “Not a Criminal” campaign over the weekend at the AIDS conference to decriminalise HIV non-disclosure, exposure and transmission; same-sex relationships; sex works and drug use.

The goal of the campaign is to “mobilise a multifaceted community action to hold governments, law, and decision-makers accountable for their global political commitments to ensure access to health and respect human rights”.

“We call on countries to retract laws that criminalise people based on their HIV status, who they choose to love and what they choose to do with their bodies in the form of sex work or the use of drugs,” said the group.

According to the group, 134 countries “criminalise HIV transmission, non-disclosure of or exposure to HIV” and a 2021 international review found that almost 90% of nations globally criminalise drug use in full, three-quarters similarly police sex work and in nearly 40% of countries, being in a same-sex relationship is either partially (24) or completely (39) illegal.

 

Image Credits: Marcus Rose/ IAS.

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.