mpox virus
Both Clade I and II strains of mpox are circulating in outbreak stricken DRC

WHO officials said that they are trying to expedite delivery of mpox vaccines to outbreak-stricken DR Congo through talks with the world’s only two mpox vaccine manufacturers, as well as appeals for vaccine donations and negotiations with DRC officials.

But speaking at a press briefing on Thursday, WHO’s Dr Mike Ryan, Executive Director of Health Emergencies, and technical lead Maria Van Kerkhove were unable to provide concrete details as to when significant quantities of vaccines could be rolled out – and how many, in light of the global shortage of supplies.  

Despite two years of millions of doses of global mpox vaccine rollout, there has been no mass administration of the vaccines so far in DRC or other west African countries. This is despite the fact that the region, and DRC in particular, is now the epicenter of the largest and deadliest mpox outbreak to date. 

The problems are multiple – ranging from global supply lines to local regulatory hurdles, stigma around mpox and vaccine hesitancy. 

Mpox lesions

At the global level, the production line of Bavarian Nordic, the Belgium-based manufacturer of one the world’s two available mpox vaccines, MVA-BN, halted its production for months in 2022 due to building renovations.  

Then in August, 2023, it received a $120 million contract from the US Biomedical Advanced Research and Development Authority (BARDA) to manufacture new mpox vaccine product in bulk.  But that has only partly restored the depleted US stockpile – believed to be the world’s largest.  

At the same time, stigma around the disease, which can be sexually transmitted, as well as around vaccines more generally has also held back progress in the DRC – one of the most vaccine-hesitant countries in Africa. 

An attempt to donate doses of mpox vaccine was stalled for more than a year, Bavarian Nordic Chief Executive Paul Chaplin said in a statement to Reuters, in December 2023. National regulatory approval of vaccines and medicines has thus inched forward at snail’s pace. 

Taking gloves off to join in partnership

Dr Mike Ryan mpox press conference
Dr Mike Ryan, WHO Executive Director of Health Emergencies at a recent press conference

“We know that production capacity of the manufacturers is closely held proprietary information sometimes, but we have an idea of production,” Ryan said, adding. “I think Bavarian Nordic has been very open to discussing how they could scale up production. 

“And I do know that GAVI and others are willing to engage around how the existing vaccines beyond donations could also be procured.  

“So we are taking the gloves off to join hands in partnership – not to beat anyone around on the head,” Ryan said. 

The MVA-BN vaccine as well as a second vaccine, LC16 KMB, produced by the Japanese firm KM Biologics, both present technical challenges in terms of their administration as well, Ryan pointed out. The MVA-BN requires two jabs – a challenge in settings like DRC wracked by conflict and insecurity.  

The LC16 vaccine, on the other hand, requires intradermal administration – a relatively simple skin jab, but still a procedure requiring training for the health workers unfamiliar with the technique.  

In addition, Ryan added, neither vaccine has yet been formally approved for use in children – and amongst the 250 deaths seen so far in DRC this year, most victims have been children under the age of 15. 

Targeting vaccines due to limited supplies 

“Given limited supply, limited availability of vaccines need to really be able to use those vaccines in a targeted way to reach those who are most at risk,” Van Kerkhove said. 

“We’re currently looking at a number of different ways the vaccines could enter into the country, led by our country office, the Ministry of Health and their partners. We’re looking at bilateral donations, at the use of vaccines as part of a response strategy – at a number of different options apply, but we’re also looking at supply,” she stressed, adding:  “We’re looking at how many doses could be available. And then of course the strategies in which those vaccines can be used in outbreak situations.”

Still trying to understand the epidemiology ’

While the barriers remain, virus transmission continues to expand within communities and geographies. 

“In 2024 alone there have been more than 3000 suspected cases and about 250 deaths with a crude case fatality ratio around 7.8%,” said Van Kerkhove, of the outbreak, the largest ever seen by the DRC to date.  

The high fatality rate is due to the fact that most cases seen so far in the DRC have been of the Clade I mpox virus, which very deadly. 

In contrast, it was the much milder Clade II virus that triggered WHO’s declaration of a global health emergency in 2022 – which it began circulating widely outside of Africa, primarily among men who have sex with men. The emergency  was declared to be over in 2023, after the successful rollout of millions of vaccines among at-risk groups in high and middle income countries.  

As well as being more deadly, the patterns of transmission of the Clade I virus in DRC and West Africa, also appear to be much more varied – although sexual transmission is a factor, it is not the only one.

DRC and global health officials are thus struggling to “better understand the epidemiology,” of the outbreak, which is happening amongs a wide variety of communities and populations – from children to sex workers.  

“There are clearly different outbreaks that are happening, some are happening among sex workers, some are zoonotic transmission and some family clusters,” Van Kerkhove said. 

“We’re working with our country office in DRC, our regional office and many different partners to look at the types of interventions that can prevent infections, but also stop transmission,” Van Kerkhove said. “And one of those interventions is vaccines.”  

“We had a big partnership meeting yesterday. A lot of people are now actively engaged. But let’s be real here.  We do have to look at the different types of scenarios and be realistic about how much vaccine is available, how quickly the vaccines can be used, and how they can optimally be used in different parts of DRC and beyond. To have the biggest impact in stopping human-to-human transmission.”

Image Credits: National Foundation for Infectious Diseases , Tessa Davis/Twitter , WHO.

What actions and strategies are required for countries and communities to have more agency in their health?

This is the topic of the latest episode of the Global Health Matters “Dialogues” podcast series, in which host Dr. Garry Aslanyan tries to “blow up some of the echo chambers that exist in global health.”

In this episode, he talks with Olusoji Adeyi, a seasoned Nigerian global health practitioner who has held many prominent leadership positions, about overhauling the existing power dynamics in global health.

Dr. Garry Aslanyan (left) and Olusoji (Soji) Adeyi
Dr. Garry Aslanyan (left) and Olusoji (Soji) Adeyi

“Aid is still used as a lever to exert power over nations at times,” Aslanyan said.

Adeyi proposed six essential changes to turn the situation around.

No. 1—Have clarity of purpose.

No. 2—Consider the needs, realities, and interests of recipient countries as the starting point for any deliberation.

No. 3—Emphasise learning.

“All too often, it’s almost as if principal actors in global health resist learning because such learning might threaten the status quo,” said Adeyi. “When it threatens the status quo, it threatens the current imbalance. And so it’s shut down or suffocated.”

No. 4—Overhaul the legacy foreign aid paradigm, including ending aid for basic health services and commodities and goods.

“This is not a call for an abrupt cessation today,” Adeyi stressed, “but it ought to be done, say by the year 2030, that’s a six to seven-year period so that there’s a finite date in sight and there is a transition out of it, with exceptions only for say countries at war, because then we’re talking about humanitarian purposes or countries that have suffered sudden and devastating natural disasters. Those would be sensible exceptions there.”

No. 5—End the current practice of technical assistance so that the aid given via technical assistance is no longer tied to the source of financing for that technical assistance.

No. 6—Developing/improving/supporting mission-critical institutions in low- and lower-middle-income countries.

Systemic Flaws in Vaccine Distribution

Adeyi highlighted the vaccine distribution process during the COVID-19 pandemic as a prime illustration of systemic flaws. He told Aslanyan that during the pandemic’s peak, “a few individuals convened at Davos and hastily drafted what would essentially become global policy for distributing COVID-19 vaccines and related technologies to low- and middle-income nations.”

Those initial sketches materialized into ACT-A for accelerated access to COVID technologies and COVAX, managed by Gavi. Consequently, during the pandemic’s peak, high-income nations stockpiled vaccines, leaving African countries in a predicament where even those countries that wanted to buy vaccines had to rely on donations rather than purchase vaccines themselves.

“If you go to buy a car, a computer, or a pair of shoes, you are empowered as the buyer,” Adeyi explained. “But if you are waiting for somebody to donate a car, a pair of shoes, or a computer to you, you are disempowered, and you are at the mercy of the donor. And, of course, COVID did not live up to the hype.

“If you had accountable leadership, they would acknowledge that failure and find ways to do better,” he continued. “But the leadership of Gavi did the exact opposite by claiming they had established a blueprint for how to get vaccines to poor people in an emergency, which was just the exact opposite of what had happened.”

Adeyi said that this illustrates how significant power imbalances result in policies, decisions, and practices that counter the interests of those intended to benefit.

Previous “Dialogues” episode: A Conversation with Daisy Hernández.

Listen to previous episodes of Global Health Matters on Health Policy Watch.

Image Credits: Screenshot, Global Health Matters Podcast.

Tired INB co-chairs Roland Driece and Precious Matsoso brief stakeholders.

Negotiations for a pandemic agreement currently underway in Geneva have made  little progress over the past four days, with member states still reading the current revised draft in plenary, and there is now talk of a further meeting in late April.

Co-chairs of the process believe that the best way forward is for member states with opposing views on particular clauses to negotiate directly with one another in smaller groups.

This emerged at a 90-minute briefing given to civil society organisations on Thursday night.

Roland Driece, co-chair of the World Health Organization’s (WHO) intergovernmental negotiating body (INB), told the briefing that the current revised draft had “not been matured” enough for a new draft to be issued, and could not predict when a new version would be available.

“We still have the stage of many countries adding textual suggestions to the text,” said Driece.

His co-chair counterpart, Precious Matsoso, said that the INB has dealt with the section on “objectives and principles”, and completed “a first reading” of articles 4, 5, 6, 7, 8, 9 and 10. 

Despite Ramadan, delegates had been meeting for additional evening sessions from 8pm-10pm and would be meeting for the whole of Saturday, she noted. The talks are scheduled to end next Thursday (28th March) but the process is very unlikely to have yielded an agreement by then.

Very few delegates were in the negotiating room at the WHO headquarters for the briefing, as two regions – most likely Africa and the European Union – were holding an informal discussion, while others were attending a briefing, said Matsoso. 

Both she and Driece expressed support for such meetings to find consensus.

Driece said there were a number of challenges, the biggest being the “time-consuming” nature of talks.

“Basically, I think these texts are progressing. But a lot of these ideas we already had on the table for a long time,” he said.

“Procedurally, the biggest challenge is, of course, the fact that you are here with a lot of countries. So if 50 of them speak out for three minutes, you can imagine that it takes a long time just to go around for one article”.

Devil in the detail

Content-wise, “the deeper you go into the details, the more difficult it is to agree”, said Driece. For example, while there was broad agreement on the need for technology transfer, discussing how this could be achieved touched on intellectual property – a point of disagreement. 

Increasing countries’ capacity to prevent pandemics had come up against poorer countries’ lack of resources to do so.

The contentious pathogen access and benefit-sharing (PABS) system is currently being discussed. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) proposing a way forward this week that involves manufacturers getting access to information about pathogens with pandemic potential in exchange for their support for certain equity-related measures.

IFPMA Director General Thomas Cueni at the CSO briefing

IFPMA Director-General Thomas Cueni, who attended the briefing, articulated the pharma industries’ proposal: “We do want a pandemic accord and companies are willing to accept mandatory commitments to delivering equitable access to essential countermeasures provided the system is workable.

“These commitments do include allocation of a percentage of real-time production of relevant therapeutics or vaccines after the pandemic is declared on the basis of a public health risk needs and demand,” said Cueni, who addressed the INB directly for the first time.

“It can include part portion expected as a donation, don’t exclude that, and part on the basis of equity based tiered pricing,” said Cueni, adding that manufacturers from the Global North and South were “fully aligned” on their position.

“We urge you to develop a flexible and agile approach to equitable access [to pathogen information], which will induce a critical mass of companies to sign up,” said Cueni.

“Coercion sadly will not work. You need to induce them, and I’m confident that it can be done,” he added, appealing for the industry to be included in a partnership to govern the proposed PABS system.

“Time is running short. So we really call for realism and pragmatism to find an agreement. We believe that the recently submitted proposal by the European Union, we don’t like it, but we do believe it does includes quite a number of elements which could make a workable system,” he concluded.

Civil society organisations raised more questions that answers during the session – most of which went unanswered by the co-chairs, who sounded tired and out of ideas.

Oxfam’s Mogha Kamal-Yanni at the INB briefing.

Pressure mounts on negotiators 

Country delegates negotiating the pandemic agreement are facing increasing pressure from a number of quarters.

Representatives from civil society organisations are camped on the doorstep of the INB  meeting room, along with journalists.

At each INB open session, a consistent set of civil society stakeholders speak and while they all represent different constituencies, they convey a similar complaint: when a pandemic strikes, they will be needed – so why aren’t they allowed in the room?

Meanwhile, a series of global campaigning efforts have converged this week. A powerful group of over 100 global leaders, including former presidents and prime ministers, sent the negotiators an open letter on Wednesday reminding them of their  “opportunity to safeguard the world” and urging progress.

The former world leaders reminded INB members of the seven million dead (officially) and the $2 trillion wiped from the world economy.

“Only a strong global pact on pandemics can protect future generations from a repeat of the COVID-19 crisis, which led to millions of deaths and caused widespread social and economic devastation, owing not least to insufficient international collaboration,” the leaders write in their joint letter. 

Signatories include former UN General Secretary Ban-ki Moon, former New Zealand Prime Minister Helen Clark, former UK Prime Ministers Gordon Brown and Tony Blair, former Malawi President Joyce Banda, and former Peru President Franciso Sagasti.

Earlier in the week, religious leaders also sent a letter to negotiators, urging that they prioritise equity.

“A bitterly inequitable vaccine distribution protected people in the Global North but left the world’s poorest to face COVID-19 unprotected for too long. Countless lives were lost unnecessarily as a result. As world leaders/negotiators, you have a moral duty to ensure that this never happens again,” they noted.

Young leaders has campaigned online in support of an equitable agreement, while Global Citizen has a petition urging world leaders to  “find a common ground” to achieve a strong agreement.

On Tuesday, 12 prominent U.S. political leaders led by Senator Bernie Sanders published a letter pressuring the US to “support strong, binding equitable access standards.”

Then there are those outside the tent, spewing out misinformation that the agreement will enable the WHO to impose global lockdowns who hope that the talks will fail – amongst them, anti-vaxxers, staunch nationalists and extreme libertarians.

Thomas Cueni, director general, IFPMA at a briefing with UN press on Wednesday in Geneva.

Pharmaceutical giants could support a formula whereby companies are guaranteed free and immediate access to pathogens with pandemic potential in exchange for binding equity agreements as part of a proposed World Health Organization (WHO) pandemic agreement, says a leading industry figure.   

The statement by Thomas Cueni, director-general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), aims to turn the classic formula for industry pathogen access in exchange for benefit-sharing (PABS) on its head. 

Cueni honed out key details of the offer to Health Policy Watch in an exclusive interview Thursday, following a press briefing for UN accredited journalists in Geneva on Wednesday where he outlined the main features of the offer. He spoke against the backdrop of intensifying debate among WHO member states meeting this week in the Intergovernmental Negotiating Body (INB) over the final shape of a pandemic accord, which is supposed to be ready for approval by May’s World Health Assembly. 

Instead of a PABS system that requires industry to pay a cash benefit outright to get pathogen samples or genetic material critical to new drug and vaccine R&D, as some civil society groups and low-income countries have proposed, he suggests focusing on “in-kind benefits” in the form of clear industry commitments for the allocation of drugs, diagnostics and vaccines. 

Depending on the final outlines of the agreement negotiated by member states, this could include mandatory set-asides of free or discounted drugs, vaccines and other countermeasures by companies that sign up to the WHO PABS system that is currently proposed as part of the draft agreement. 

“Commitment is what is voluntary. But industry offers to sign up to binding obligations if the system is workable. And for the system to be workable, it really needs to have this free access to pathogens,” Cueni said. 

He added that, effectively, the position acknowledges a linkage between access and benefits sharing – one that industry long sought to avoid – but in a different kind of paradigm. 

“The two go together,” he admitted, “because countries want industry to sign up in terms of mandatory obligations in terms of sharing medical countermeasures, and industry is ready to do that – but states very firmly that, in able to develop the medical countermeasures, we need this access to happen.”

In-kind benefits not cash 

SARS-CoV-2: Pharma argues pathogens should be treated differently from other biological resources, enabling swift and unhindered sharing of genetic sequences.

But Cueni also flatly rejected proposals for what he described as a  “sales tax” on industry participation in the PABS system,  saying commitments to donated drugs and vaccines or their tiered pricing would be more effective. 

“We are not willing to be a cash card,” he stated. 

As an example of the precedent that industry doesn’t want to imitate, Cueni pointed to the fees assessed to pharma now for accessing flu pathogens, under the WHO Pandemic Influenza Preparedness framework.  

“There’s a lack of transparency, there’s a lack of accountability, and you are relying on 2024 contributions based on industry sales in 2009 – which somehow doesn’t make you trust that this would work in the future,” Cueni said.

Moreover, the system is so bureaucratically awkward that only 14 sample sharing agreements have actually been signed over the past decade, he asserts. 

In contrast, for the PABS to ever be workable, a much wider range of pathogen sample sources and data types (e.g. genetic data and not only biological samples) need to be in play – with the system allowing for very rapid and transparent sharing in the R&D community.  

And governance as well as operational costs should be shared by all of the system’s stakeholders – and with industry also having a seat at the table in the governance mechanism that is developed..

“We think that the only way to do this is as a partnership,” Cueni declared.  We’ll have WHO as a central player.. You will clearly have a majority of member states. But it shouldn’t be a closed process,” he said, noting that along with industry representations, research institutions, particularly pathogen data banks, might also play an important role.   

Precedent for this exists, he said, noting that The Global Fund, and Gavi, the Vaccine Alliance, also have industry on their boards as well as civil society advocates.  

Backing by leading pharma manufacturers 

Cueni pointed to a little-noticed IFPMA statement on 11 March, backed by a number of leading pharma manufacturers, as laying out key elements of the industry plan. Those firms included BMS (Bristol Myers Squibb), Gilead, Sanofi, Roche, Pfizer and MSD (Merck, Sharp & Dohme).

Key to the statement is a commitment to:  “reserve a percentage of real time production volume of a relevant therapeutic or vaccine for equitable distribution on the basis of public health risks, needs, and demand. 

“This could include a portion expected as a donation to LICs [lower-income countries] and/or a portion negotiated under equity-based tiered pricing with the lowest tiers dedicated to LICs and LMICs.”

Elaborating further on the offer to Health Policy Watch, Cueni said that industry’s binding obligations in the PABS should include the “flexibility to respond to the dynamics of any pandemic based on medical need. 

“Looking at COVID, I really emphasize the medical need point,” he said, noting that the initial hotspots for the pandemic were in Europe, notably Italy, but later followed by India, “quite a few Latin American countries, and then parts of Africa.” 

Pandemic Accord provisions on pathogens should supersede Nagoya Protocol 

The Convention on Biodiversity (CBD) aims to protect the world’s biodiversity, mostly found in developing countries. But the CBD’s Nagoya Protocol provision allowing countries to demand compensation in exchange for accessing pathogens can harm vital R&D into medicines and vaccines, pharma leaders argue.

Finally, Cueni argues that one key incentive for industry to sign up to the proposed PABS in any  pandemic agreement arrangement would be its potential to “override” pre-existing provisions around access to pathogens and benefit sharing  in Article 4 of the Nagoya Protocol of the Convention on Biodiversity (CBD). 

This could be established by designating the PABS a “Special International Instrument” (SII) that would thus automatically override the CBD’s protocols and, by inference, related national legislation. 

National rules established following the Nagoya Protocol’s ABS provisions have, at times, greatly slowed down the development of vital drugs at critical moments such as the 2016 Zika virus outbreak in Latin America, Cueni contends.

“The benefit of signing up is that you would have legal certainty of not violating Article 4 of the Nagoya Protocol,” he says. 

“And if this system would bring open and free access to pathogens, there would be multiple countries from the global north and south, sign up to it and have access to the network of certified labs in the world which shares data and allows you to work on prototype vaccines.”     

Political fallout likely

Designating the PABS as a Special International Instrument that supersedes the Nagoya Protocol is likely to be controversial among those LMICs  that have already set up national ABS systems for pathogens, Cueni admits. 

At the same time, he maintains that sharing the benefits outright of drugs developed from dangerous pathogens to those countries most in need, makes more sense than creating a new international financial model that, effectively, makes the trade in pathogens profitable. 

“The attempts to monetize pathogens scares me, because at the end, monetizing, which means ‘I share if you give me money’ … means pathogens could become a business model. You do not really want that,” he said, speaking at Wednesday’s press briefing. . 

“I’ve been involved in Switzerland in the ratification of CBD and the Nagoya Protocol. Everybody wants to protect the beauty and richness, diversity of biodiversity –  whether it’s the Amazon rainforest, or melting glaciers in Switzerland, or forests. 

“I’ve never met anybody who is arguing to protect the diversity of pathogens. Pathogens, you know, can be dangerous, they can cause pandemics, they can kill people, therefore, the notion of treating pathogens in the ABS… [in the model of] I gave you the information if you give me money doesn’t really make sense.”

Cueni’s comments on the perverse nature of the ABS business model were met with resistance from some civil society voices who see the trade-off as one way to correct the imbalance between wealthy pharma firms and poor countries.  It is in developing countries where pathogens like HIV, Ebola and mpox that originally circulated among wild animals first began their journey into human bodies and communities. 

“Open pathogens and closed IP isn’t fair,” said Oscar Lizarazo-Cortés, a professor at the Universidad Nacional Colombia. But not everyone sees it that way either. As Jamie Love, head of Knowledge Ecology International (KEI), one of the leading civil society advocating for more pharma IP sharing and transparency, said in another X post:

“I agree with Cueni.  

“If you protect pathogens (not exactly what is going  on in the text, but in general), you are protecting pathogens, at least in the sense that knowledge about the pathogens is not open.  You may want to justify that, but it is what it is,” Love added.

 

Image Credits: Fletcher/HPW, NIAID-RML , Lubasi.

Routine testing for tuberculosis in Lima, Peru.

Tuberculosis has long been the neglected stepchild of global health – but new diagnostic tools and treatments, artificial intelligence (AI) and debt swaps to help countries meet their targets have come into play and are making a difference. 

“There is fresh momentum,” says Dr Jamie Tonsing, Senior TB advisor at the Global Fund, in a wide-ranging interview with Health Policy Watch.

“I’ve just come back from a meeting in Manila, where the discussion was all around AI for TB,” she adds.

One of these involves an AI tool that can read chest X-rays and predict whether a person is likely to have TB.

“The chest X-ray goes into the computer and the image is read by software and gives you a threshold above which a person is likely to have TB,” explains Tonsing.

“It’s a screening tool that needs to be followed by a proper molecular test. But this is very exciting because we don’t have radiologists everywhere, and TB is often in the most hard to reach, vulnerable population groups.”

Up to 50% of people with TB do not have the classical symptoms of TB, Tonsing adds.

“So the only way they will be diagnosed early and before they have symptoms is when they do a chest X-ray. And so that’s why we’re very excited by this new advance in technology.”

Jamie Tonsing, Senior TB advisor at the Global Fund,

Those with TB can be started on treatment immediately. Children under the age of five and people living with HIV who don’t have TB but have been exposed to someone with the disease, can be given TB preventive treatment to protect them.

Over three-quarters of international financing for TB comes from Global Fund, which also spends around $150 million per year to new digital tools. These are being used in places like Bangladesh, Paraguay and Indonesia to screen people in remote areas.

Bangladesh, is using digital X-rays with AI and telemedicine to rapidly screen people for TB, while health workers in Paraguay, are using portable X-ray machines and AI technology in prisons screen and diagnose people with TB fast, according to Dr Mohammed Yassi, the Global Fund’s TB advisor.

Cheaper testing for drug-resistance

GeneXpert diagnostics have become the gold standard for TB testing, particularly for drug-resistant TB (DR TB), which is difficult to diagnosis through the traditional sputum smear technologies or chest X-rays.  GeneXpert can rapidly detect rifampicin-resistant TB (a proxy for DR-TB diagnosis) along with drug-susceptible TB.  But the diagnostic machines need electricity and are expensive to operate.

Four years ago, the World Health Organization (WHO) endorsed another rapid molecular test called Truenat, which is also able to detect DR-TB – but is cheaper than GeneXpert and can run on batteries.

The Global Fund and Stop TB Partnership have signed an agreement with Truenat’s manufacturer, Molbio Diagnostics, to provide the machines at a reduced price in all countries that are supported by the two organisations and USAID.

In theory, results from these machines are supposed to be processed in two hours. But in practice, it usually takes clinics a few days to process.

“We need to find the people we are missing. So despite all the good progress, our global detection rate is 77% and we have said we need to get that up to 90%. So all the innovations are important, but what we also really need is point-of-care rapid tests like we have for malaria and HIV,” says Tonsing.

“In the past year, the Global Fund secured a 20% reduction in the price of the most commonly used molecular diagnostic test and a 55% reduction in the price of a key treatment for multidrug-resistant TB,” according to Peter Sands, executive director of the Global Fund.

Better treatment for DR TB

People with DR-TB used to spend 12 to 24 months in hospital, and take lots of pills and injections. But in May 2022, this changed dramatically when the WHO recommended an all-oral six-month regimen known as BPaLM –  a regimen of bedaquiline (B), pretomanid (Pa), linezolid (L) and moxifloxacin (M).

“The shorter duration, lower cost, lower pill burden and high efficacy of this novel regimen should enable much better treatment and treatment outcomes.. while also helping health systems to provide care for more people,” the WHO announced.

But the challenge is to ensure that countries adopt the new guidelines. Drug resistant TB is very high in the central region of Eastern Europe, but the management of TB is still  centralised with people still being admitted to hospital for months in many countries. 

The Global Fund is investing in BPalM, and encouraging countries to adopt the regimen, allow patients to stay at home and train staff and civil society organisations about how it works.

The older drug-resistant TB treatment (above) compared with new BPaL regimen (below).

Innovative financing

COVID has depleted many countries’ budgets, especially in the low-and middle-income countries most likely to be struggling with TB.

“Domestic budgets for TB are often not being increased commensurate with the need,” says Tonsing. “Every year, we get around $5 billion for the global TB response whereas the need is around $13 billion, so that gap is huge.”

Since 2017, the World Bank and the Global Fund have supported many countries by investing with blended finance transactions. For example, a loan buydown in India was tied to increased domestic financing for TB care and prevention. 

Debt2Health is an innovative financing mechanism designed to increase domestic financing in health by converting debt repayments into investments in public health programmes. Under individually negotiated “debt swap” agreements, a creditor nation forgoes repayment of a loan when the beneficiary nation agrees to invest all or part of the freed-up resources in a Global Fund-supported programme.

For example, in April 2021 Germany, Indonesia, and the Global Fund signed an agreement to  increase support to TB in Indonesia by converting €50 million of debt owed by Indonesia to Germany into investments in public health programmes supported by the Global Fund in Indonesia.

Still off track

“We have recovered from COVID-19 and in 2022, a record number of TB cases were identified – 7.3 million out of 10.6 million estimated cases. That’s a big new high and we  think, once we get the 2023 data, it will easily cross over eight million,” says Tonsing.

“So we’re getting back on track after being off track but but I don’t think we will be able to make it to the UN high level meeting, or even the 2030 SDG targets.”

Image Credits: Socios en Salud, Marc Bader/ The Global Fund, Dato Koridze .

A counsellor from MSF talks to a person with drug-resistant TB at the TB hospital in Bydgoszcz, Poland.

Over the last century, Europe – including  Northern, Western, Southern and Central European countries – made remarkable progress in the near elimination of tuberculosis (TB) due to improved socio-economic conditions and advancements in research and development. 

However, a recent surge of TB in Europe, coupled with lack of structural preparedness within many European Union (EU) countries to address it, threatens to undo this hard-earned progress.

Figures released from the WHO Europe region on Thursday also show 7,000 excess TB deaths in Europe during the COVID-19 pandemic and that only 60% of TB patients were cured with first-line medication.

The EU must put this forgotten disease back on its health agenda, and urgently address the testing, prevention, and access to treatment needs for people affected by TB and its drug-resistant forms.  

Poland: A case study

Médecins Sans Frontières (MSF) began working with people with TB in Poland in 2022 in the context of the war in Ukraine, by supporting refugees from Ukraine and trying to ensure the continuity of their TB treatment in close collaboration with the Polish national health programme. 

Having worked with people with TB for more than 30 years in lower- and middle-income countries, we were shocked to note that the standards for testing, treatment and prevention of TB and its drug-resistant forms were outdated in Poland, and lacked an integration of the most up-to-date science – as outlined in the World Health Organization’s (WHO) guidelines – into its national health policy.

People with drug-resistant TB (DR-TB) had to stay in hospital for the entire duration of their treatment, which consisted of old, toxic and less effective regimens lasting at least 18 months and including dozens of daily pills and painful daily injections that are known to cause devastating side effects.

That there was no access to the newer, more effective TB drugs that have been available elsewhere for the past decade, hindered the use of the current WHO-recommended shorter, oral regimens that are adapted for everyone, including children.

The lack of access and registration of child-friendly, water soluble formulations of TB drugs meant that children had to swallow crushed and bitter medicines without appropriate weight-based doses. 

Additionally, people with drug-sensitive TB still have to take 11 pills per day even though the availability of fixed-dose combinations has reduced the pill burden to around 3 pills per day in many of the lower- and middle-income countries where we work to treat TB.

Moving onto the right track

The ongoing national and international efforts by WHO, MSF, and many other organisations in the last two years have led to significant steps in the right direction, with the Polish government now bringing back attention to this forgotten crisis.

In a bid to offer continuity of treatment to Ukrainian refugees affected with TB, the Polish government started to prioritise the management of this disease in 2022 and has made notable progress since then. 

In a notable move, the government launched a pilot project in partnership with MSF and WHO for ambulatory treatment of DR-TB that has resulted in reduction in duration of hospital stay from several months to a few weeks. The government also established a system of reimbursement for hospitals to cover the testing and treatment of TB. 

Poland’s co-chairmanship of the TB United Nations High Level Meeting in 2023 led to the adoption of a political declaration with strong commitments to urgently end the global TB epidemic, and signals a paradigm shift by bringing the disease to the forefront of its health agenda.  

We have to keep at it. While the Polish government has made important moves since 2022, we believe that further actions are further needed if the efforts to address TB are to succeed.

The government must establish a system to actively identify people affected with TB , initiate timely treatment, and effectively control transmission of the disease. Worryingly, an MSF internal analysis revealed that over half of the people affected by TB in 2023 remained undiagnosed and untreated whilst living in Poland for at least two years.

Prices of the newer drugs and regimens must be reduced. The WHO-recommended six-month treatment regimen for DR-TB, consisting of bedaquiline, pretomanid, linezolid and moxifloxacin (BPaLM), is still exorbitantly priced at €45,300 in Poland even though it is available at €380 in lower- and middle-income countries through the Global Drug Facility, an international procurement agency. 

All TB drugs should be made available for prevention and individualised treatment, ensuring that people with TB – irrespective of their drug-resistance profile, age and other co-morbidities – have access to appropriate treatment.  

Paediatric TB formulations and fixed-dose combinations of TB drugs for both adult and children, already available in many other countries, must be made accessible in Poland as well.  

The Polish government should urgently establish a National TB programme adopting and implementing the current WHO treatment guidelines. 

EU countries lag behind

TB patient Oleg Chutvatov examines an X-ray of his lungs with a doctor at the TB hospital in Kharkiv, before the Russian invasion of Ukraine disrupted health services in his country.

Regrettably, the challenges we see in eliminating TB are not exclusive to Poland but are common in many EU countries. This affects not only access to services in-country, but also the continuity of care for people with TB crossing borders, especially during emergencies.

EU must put TB back on the agenda as a health priority

The case study of Poland is indicative of a more general lack of preparedness within the EU to combat this deadly infectious disease. Such a lack of preparedness has certainly been highlighted and challenged by the rapidly changing international geopolitical situation, to which the war in Ukraine has contributed, and should serve as a compelling wake-up call for the EU to advance its efforts to deal with TB in the region.

As Poland convenes a TB summit with international stakeholders this week to initiate discussions for re-establishing a national TB programme, we urge all countries in the region to proactively revitalise their TB policies and programs, prioritise people-centered care, and take urgent steps to ensure universal access and affordability of TB tests and newer, all-oral treatment regimens.

We also call on the European Commission and concerned departments, including the Health Emergency Preparedness and Response (HERA), and the European Medicines Agency (EMA) to immediately focus on enhancing access to all the medical tools needed to combat TB across the EU.

Only through our collective efforts can we hope to defeat this ancient, yet curable infection, and prevent unnecessary suffering and deaths.

Krzysztof Herboczek is a medical doctor who has worked for Médecins Sans Frontières since 2006 in various positions in the past, including as a TB doctor, manager and adviser. Since 2023, he has been the medical referent for the MSF TB project in Poland.

Joanna Ladomirska is the Medical Coordinator for MSF in Poland. She is a nurse who has 16 years’ experience in humanitarian work, including in countries in Africa, South America, South East Asia and Europe. She has worked in response to epidemics, natural disasters and conflict as well as HIV and TB, and describes herself as “a mother, an activist, and a doer with a humanitarian heart”.

Image Credits: Aleksander Binek/ WHO, The Global Fund / Evgeny Maloletka.

Glacier
Last year smashed records as the hottest year since 1850, causing the loss of hundreds of gigatonnes of ice coverage and extreme weather across the globe

Heatwaves, floods, wildfires, and droughts unleashed global mayhem in 2023, as the year broke multiple climate records, according to the World Meteorological Organization’s (WMO) State of the Global Climate Report released this week.

It was the hottest year in recorded history, with global average near-surface temperature of 1.45℃ above the pre-industrial baseline.

“Never have we been so close – albeit on a temporary basis at the moment – to the 1.5° C lower limit of the Paris Agreement on climate change,” said WMO Secretary-General Celeste Saulo at a press conference this week.

“Climate change is about much more than temperatures. What we witnessed in 2023, especially with the unprecedented ocean warmth, glacier retreat and Antarctic sea ice loss, is cause for particular concern,” she said.

‘Climate crisis is the defining challenge that humanity faces’

The WMO’s annual report offers a dire snapshot of the world’s climate, sounding a “red alert” for countries to double down on efforts to control global warming. 

For United Nations (UN) Secretary General António Guterres, the earth itself is issuing a “distress call” as 2023 saw record greenhouse gas levels, surface temperatures, ocean heat and acidification, sea level rise, and Antarctic sea ice cover and glacier retreat. 

“The impact of all this is stark, brutal and accelerating with deadly force,” said Guterres in a video message at the launch of the report.

Mean surface temperature anomalies as a result of climate change
Both landmasses and oceans saw record-setting heat

The report confirms 2023 as the hottest year on record, noting that globally, every month from June to December broke records. 

September 2023 was particularly noteworthy, surpassing the previous global record for that month by a wide margin (0.46 to 0.54 °C).

The shift from La Nina to El Nino weather conditions have exacerbated the greenhouse gas effects on warming, and the report also warns of rapidly warming oceans. 

At any given point in 2023, close to a third of the oceans were experiencing a heatwave, by the end of the year, most of the global oceans had experienced heatwave conditions. The most affected was the North Atlantic, with marine temperatures exceeding 3°C above average. 

However, the southern ocean continues to store the largest amount of heat, accounting for around 32% of the global ocean heat content (OHC) content increase since 1958. The Atlantic Ocean accounts for approximately 31% of the global 0–2000 m OHC increase; the Pacific Ocean around 26%.

These intense marine heatwaves harm entire ecosystems and further stress coral reefs. The combination of warming oceans and increased atmospheric carbon dioxide concentrations have further acidified the global ocean. The WMO expects the warming to continue “irreversibly” on a dramatic scale of “hundreds to thousands of years.”

Ice sheets shrink, sea level rise doubles 

Ice sheet coverage graphs
Both Greenland and Antarctic Ice Sheets experienced dramatic losses in ice mass

Heatwaves are not the only phenomenon threatening the planet’s ocean. Global mean sea level reached record highs this year, while the rate of rise in the past ten years has doubled from 2.13 mm/year between 1993 and 2002, to 4.77 mm/year. 

Several factors converge to create this alarming rise: warmer oceans, the switch from La Nina to El Nino, and melting glaciers. 

Both glacier and sea-ice melt accelerated this past year, with Antarctic sea-ice reaching “an absolute record low” not seen since 1979. 

The Greenland Ice Sheet and Antarctic Ice Sheet lost 372 gigatonnes of mass per year from 2016 to 2020, up from 105 gigatonnes/year in 1992-1996.

“Antarctic sea ice was one million square kilometres smaller than the previous record low for the time of year. That’s an area almost 25 times the size of Switzerland,” noted Guterres. 

Beyond the poles, glaciers in western Northern America and Europe suffered the largest loss of ice on record, particularly in the European Alps. The mountain range lost 10% of its remaining volume in just the past two years. 

The toll of extreme weather

Canadian wildfires graph
Canadian wildfires burned through millions of hectacres in the past year alone

Extreme weather including cyclones, rainfall-induced flooding, wildfires, and heatwaves continued to lead to severe socioeconomic impacts. 

Wildfires in Hawaii, Canada and Europe led to loss of life, the destruction of homes and large-scale air pollution. Flooding associated with extreme rainfall from Mediterranean Cyclone Daniel affected Greece, Bulgaria, Türkiye, and Libya. 

“There were particularly devastating consequences for vulnerable populations who suffer disproportionate impacts,” writes WMO Secretary-General Saulo in her forward to the report.

“Extreme climate conditions exacerbated humanitarian crises, with millions experiencing acute food insecurity and hundreds of thousands displaced from their homes.”

Food security, population displacement and impacts on vulnerable populations continue to be of mounting concern in 2023, with weather and climate hazards exacerbating the situation in many parts of the world.

The report calls attention to the fact that the number of people who are acutely food insecure worldwide has more than doubled, from 149 million people before the COVID-19 pandemic to 333 million people in 2023, citing World Food Programme (WFP) numbers.

Climate and extreme weather events are directly tied to the dire food insecurity situation in much of the world; in Southern Africa, for example, Cyclone Freddy submerged extensive agricultural areas and inflicted severe damage on crops in February 2023.

“Across the globe, millions of people, including internally displaced persons, refugees, and migrants, are on the move or have been forced to flee their homes and communities because of disasters exacerbated by climate stresses and shocks,” states the WMO.

The consequences of global inaction

Greenhouse gas emissions
Greenhouse gas emissions continued to climb in 2023 despite growing investment in renewables

“The scientific knowledge about climate change has existed for more than five decades, and yet we missed an entire generation of opportunity,” said Saulo said to media in Geneva. 

She urged the climate change response to be governed by the “welfare of future generations, but not the short-term economic interests.”

The cost of inaction is staggering, the report warns. In the next 75 years, it may reach 1.266 trillion, representing the difference in losses between a business-as-usual scenario and a 1.5° C pathway. Noting that this figure is likely a significant underestimate, the UN weather experts call for immediate climate action.  

The report emphasizes that adaptation finance continues to be “insufficient.” Though adaptation finance reached an all-time high of 63 billion in 2021 and 2022, the global adaptation financing gap is widening, falling well short of the estimated 212 billion per year needed up to 2030 in developing countries alone.

There is, however, reason for hope. Renewable energy generation and capacity surged this past year, driven by solar, wind, and hydropower. 

In 2023, renewable capacity additions increased by almost 50% from 2022, for a total of 510 gigawatts (GW) – the highest rate observed in the past two decades.

“The good news is that we can still keep our planet’s long-term temperature rise below that limit, and avoid the worst of climate chaos,” remarked Guterres. “We know how to do it.” 

“There’s still time to throw out a lifeline to people and planet. But leaders must step up and act – now.”

Image Credits: Melissa Bradley, World Meteorological Organization.

Girls and women protest outside Gambia’s parliament this week in protest against attempts to reintroduce female genital mutilation.

An effort by Gambia’s parliament to reintroduce female genital mutilation (FGM) has been met with widespread condemnation by women’s and human rights organisations.

Gambia’s Members of Parliament voted overwhelmingly this week to refer the Private Member’s Bill that seeks to repeal the Women’s (Amendment) Act of 2015 that banned FGM to parliament’s business committee for further consideration. It may be reintroduced within weeks.

Supporters of the Bill claim that the practice is important for “cultural and religious reasons” in the conservative Muslim-dominated country. 

Only four of the 47 MPs present opposed the decision to entertain the Bill further in Gambia’s parliament, which is made up of 53 male MPs and only five women MPs.

However, Deputy Speaker Seedy SK Njie expressed his support for the current status quo on X, stating that “the FGM law is here to stay. We’re committed to keeping Gambian women and girls safe.”

The Bill was introduced by Almameh Gibba, an MP from the Alliance for the Patriotic Reorientation and Construction (APRC), with the support of Imam Abdoulie Fatty, who advocates for FGM for religious and cultural reasons.

It is being opposed by a number of organisations, including the Network Against Gender-Based Violence and Think Young Women, which is also opposed to child brides.

Despite the banning of FGM nine years ago, almost three-quarters of Gambian women are estimated to have been subjected to the practice, and almost half were cut before their 15th birthday.

“It is very disappointing that, after the long fight Gambian activists put up to advance women’s rights, parliament is preparing to consider this backward move,” said Michèle Eken, senior researcher at Amnesty International’s West and Central Africa office.

“The potential repeal of the FGM ban in The Gambia sends a dangerous message, not just domestically, but internationally,” said Women Leaders Network for Development. (RFLD)

“Other countries grappling with FGM might see this as an opportunity to dismantle their own safeguards, putting millions more girls at risk.

“Proponents of repealing the ban often frame it as an attack on cultural and religious traditions. However, this narrative is misleading. Culture is not static; it evolves with time. Harmful practices, like FGM, have no place in a society that values human rights and equality. The right to health, enshrined in international law, supersedes cultural justifications for practices that cause demonstrable harm,” added RFLD.

Lack of enforcement

Despite the ban on FGM in the three-million strong nation, there has only been one conviction in the past nine years involving three women for cutting babies aged four to 12 months old, according to women’s rights activist Jama Jack. They received fines which were paid by Fatty via a public fundraising campaign, added Jack.

“We must recognise that the practice is rooted in the desire to control our bodies and our sexuality, and any concessions we make today will be applied to other forms of violence we face, because the goalpost will always be shifted,” Jack wrote in a blog this week.

“We have already seen Abdoulie Fatty mention the law prohibiting child marriage, and just as we predicted, they will come for every legislation protecting women and girls.”

FGM involves the partial of total removal of external female genitalia – supposedly to “control” women’s sexuality – and is usually performed on girls under the age of 15.

Around 90% of women in Somalia, Guinea and Djibouti are subjected to FGM, and a range of organisations fear that Gambia’s reversal will encourage others in West Africa.

Over 230 million girls and women alive today have undergone female genital mutilation (FGM), according to a report from the UN children’s agency, UNICEF, released earlier this month. This is a 15% increase since eight years ago.

“The pace of progress to end FGM remains slow, lagging behind population growth, especially in places where FGM is most common, and far off-pace to meet the UN’s Sustainable Development Goal to eliminate the practice. The global pace of decline would need to be 27 times faster to end the practice by 2030,” UNICEF notes.

However, progress to prevent FGM is possible. In the past 30 years, FGM has declined in Kenya from moderate to low prevalence; Sierra Leone has dropped high to moderately high prevalence and Egypt is beginning to decline from a previously near-universal level.

Violation of rights

“In every form in which it is practised, FGM is a violation of girls’ and women’s fundamental human rights, including their rights to health, security and dignity,” according to UNICEF, which estimates that four million girls and women are at risk every year.

“FGM has no health benefits and can lead to serious, long-term complications and even death. Immediate health risks include haemorrhage, shock, infection, HIV transmission, urine retention and severe pain,” said UNICEF, adding that psychological impacts ranged from girls losing trust in her caregivers, anxiety and depression.

“In adulthood, girls subjected to FGM are more likely to suffer infertility or complications during childbirth, including postpartum haemorrhage, stillbirth and early neonatal death.”

Ironically, Gambia’s decision comes in international women’s month and during a global meeting of the UN Commission on the Status of Women. The theme of the 68th meeting of the commission is “Accelerating the achievement of gender equality and the empowerment of all women and girls by addressing poverty and strengthening institutions and financing with a gender perspective”.

Microscopic view of mycobacterium tuberculosis in the lungs.

A Phase 3 trial of a tuberculosis vaccine candidate has been launched in South Africa, according to the Bill & Melinda Gates Medical Research Institute (Gates MRI).

The candidate vaccine – referred to as  M72/AS01E – “could potentially become the first vaccine to help prevent pulmonary TB in adolescents and adults, the most common form of the disease, and the first new TB vaccine in over a century”, according to Gates MRI, which is sponsoring the trial along with funding support from Wellcome Trust and the Bill and Melinda Gates Foundation.

“The launch of this pivotal Phase 3 trial demonstrates our commitment to harnessing the power of medical innovation to fight diseases like TB that are particularly devastating for low- and middle-income countries,” said Dr Emilio Emini, CEO of the Gates MRI. 

“Clinical study of the vaccine will still require years, but our incredible partners in South Africa and elsewhere who have come together for the Phase 3 study share our hope in the vaccine’s potential.”

M72/AS01E was originally designed and clinically evaluated by the biopharma company GSK up to the proof-of-concept phase (Phase 2b). 

In 2020, GSK announced a partnership with the Gates MRI for its further development. GSK continues to provide technical assistance and is supplying the adjuvant component for the Phase 3 trial and will provide the adjuvant post-licensure should the trial be successful. An adjuvant is an ingredient used in some vaccines that can help create a stronger immune response. 

Up to 60 trial sites

“Reaching Phase 3 with an urgently needed TB vaccine candidate is an important moment for South Africans because it demonstrates that there is a strong local and global commitment to fight a disease that remains distressingly common in our communities,” said Dr Lee Fairlie, national principal investigator for the trial in South Africa.

“South Africa also has considerable experience with TB- and vaccine-related clinical trials and a strong track record for protecting patient safety and generating high quality data essential for regulatory approvals.”

At full capacity, the trial will include up to 20,000 participants, including people living with HIV, at up to 60 trial sites in South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam. 

“After dedicating over 20 years to developing this essential candidate vaccine, we at GSK are delighted that the Phase 3 trial is underway,” said Deborah Waterhouse, CEO of ViiV Healthcare and GSK’s president of global health.

“Developing and ensuring access to global health products is complex but our collaboration with the Gates MRI, Wellcome and the Gates Foundation exemplifies the transformative power of leveraging diverse partners’ expertise to change the trajectory of challenging diseases, like TB, which place a huge burden on communities around the world.”

WHO investment case for screening and prevention

Every dollar invested in TB screening and prevention will translate to $39 in economic and health gain, according to the World Health Organization (WHO) investment case released this week.

The analysis is based on the results of a modelling study developed with the governments of four countries – Brazil, Georgia, Kenya and South Africa. 

“The investment case outlines the health and economic rationale for investing in evidence-based, WHO-recommended interventions on TB screening and prevention that can contribute to advancing universal health coverage,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Today, we have the knowledge, tools and political commitment that can end this millennia-old disease that remains one of the world’s top infectious killers,” he said. 

TB causes 1.3 million deaths each year and affects millions more, mostly in low-and middle-income countries. Global efforts to combat TB have saved an estimated 75 million lives since the year 2000, according to the WHO.

This year, World Tuberculosis Day on 24 March is being commemorated under the theme ‘Yes! We can end TB!’ conveying a message of hope.

But WHO experts conceded that access to TB drugs remained constrained due to limited investments, speaking at a press conference on Monday. 

Screening and preventive treatment cuts costs

Implementing TB screening along with preventive treatment can substantially reduce TB incidence and mortality, according to the investment report. It argues that these crucial public health investments are essential for addressing the needs of vulnerable populations.

In 2022, WHO reported a significant worldwide recovery in the scale-up of access to TB diagnosis and treatment services, with the highest figure recorded since WHO began global TB monitoring in 1995.

But so far the scale-up of access to TB preventive treatment has been slow. It is also vital to offer TB preventive treatment to those with HIV, household contacts of TB patients, and other high-risk groups.

The global number of people living with HIV and household contacts of people with TB who were provided with TB preventive treatment increased to 3.8 million in 2022 or about 60% of those targeted that year in line with the commitments made at the UN High-Level Meeting of 2018.

Dr Saskia Den Boon, Technical Officer at the WHO’s Global TB Programme.


“Strategies to provide TB preventive treatments are often linked to screening to find and treat people with TB earlier in the course of their disease. And this helped to reduce transmission and improve outcomes. TB screening is a key intervention to find and treat the millions of people not accessing care for TB disease,” Dr Saskia Den Boon, Technical Officer at the WHO’s Global TB Programme.

Lack of vaccines

Vaccines are normally an effective preventive strategy but currently the only available vaccine for TB is the BCG vaccine that is over a century old.

“That’s the BCG, which was only for kids and it is not really effective to provide adults protection against TB,” said Ashna Ashesh, a TB survivor and public health professional and representative of WHO Civil Society Taskforce on TB.

“We’ve seen how fast we can work when we put our money where our mouth is with COVID. We had a vaccine within a year. But that wasn’t because we started from scratch in that one year. We invested in decades of mRNA research that then allowed us to quickly develop the COVID vaccine.”

Dr Tereza Kasaeva, Director of the Global Tuberculosis Programme at the WHO


“It’s absolutely unacceptable that in 21st century with a lot of innovations, we still don’t have new effective TB vaccine,” said Dr Tereza Kasaeva, WHO’s TB director. “This area of the development of new vaccines, it’s very expensive, highly risky area,” she added. 

Kasaeva said that there are more than 16 candidates in the pipeline and newer vaccines could come in the market in the next five years but added that investments are needed.

“And if you look, first of all at the situation with funding of TB research, [it is] less than o$1 billion annually. Overall investments in TB research are absolutely not sufficient,” she said. 

Multidrug-resistant TB 

Multidrug-resistant TB (MDR-TB) remains a public health crisis. While an estimated 410,000 people developed multidrug-resistant or rifampicin-resistant TB in 2022, only about two in five people accessed treatment.

The global targets approved at the 2023 UN High-Level Meeting on TB include: reaching 90% of people in need with TB prevention and care services; using a WHO-recommended rapid test as the first method of diagnosing TB; providing a health and social benefit package to all people with TB; ensuring the availability of at least one new TB vaccine that is safe and effective; and closing funding gaps for TB implementation and research by 2027.

Following the commitments made by Heads of State at the UN High-Level Meeting in 2023 to accelerate progress to end TB, this year’s focus is on tangible action, the world health body said. 

Additional reporting by Kerry Cullinan.

Image Credits: Roche .

A child gets vaccinated against measles during the outbreak in the DRC.

Discussion about disease outbreaks dominated the biannual meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – which its chairperson described as  “alarming” as the aim of the group is to ensure early vaccination to prevent outbreaks.

“The outbreak-related recommendations is a sign that normalcy is starting to be living with outbreaks,” warned Dr Hanna Nohynek, chair of SAGE, which advises the World Health Organization (WHO) on immunisation.

“My plea to nations is to give us sufficient resources so that we can run our programmes properly and our surveillance systems properly so that we don’t have to deal with outbreaks but we can actually keep up our good vaccine coverage.” 

Mpox: different epidemiology 

There is a “significant” mpox outbreak in the Democratic Republic of Congo (DRC) that involves Clade I of the disease and is predominantly affecting children.

But this outbreak has “a very different epidemiology” from the multi-country outbreak in 2022, which involved the milder Clade II and was mainly spread through sexual transmission, particularly in men having sex with men, said Dr Kate O’Brien, WHO Director of Immunization, Vaccines and Biologicals.

Dr Kate O’Brien, WHO Director of Immunization, Vaccines and Biologicals.

“It’s really important to understand what the source of the mpox exposure is [in DRC], which is presumably related in part to zoonotic transmission, and potentially transmission then in the household or in the community,” she added.

Children in the DRC are being given mpox vaccines (both on- and off-label, depending on which vaccine is involved), and O’Brien urged the country to conduct evaluations of its performance “which we expect to be very high in settings of community transmission”.

“The vast majority of mpox vaccine data is from high income countries and predominantly in communities where there has been sexual transmission,” she noted.

“We have a lack of research, be it clinical research or epidemiological research, in relation to diseases that are most pressing in low income countries and the issue came up in particular in relation to mpox,” said SAGE’s executive secretary, Dr Joachim Hombach, who is also WHO senior health advisor.

“More research needs to be done and, whenever possible local research because the competencies are there it is just that the resources are not, so that more data is generated to allow for more robust policy and for more robust understanding of the disease epidemiology.”

SAGE’s executive secretary, Dr Joachim Hombach.

Measles and misinformation

WHO releases annual measles case and death estimates, and for 2022 there were over nine million cases and 136,000 deaths.

“There are now over 50 countries that have large and disruptive measles outbreaks ongoing during the course of this past calendar year, and that’s about double the number of countries as occurred in 2022,” said O’Brien.

“We warned very much regularly during the course of the [COVD-19] pandemic what the impact would be of the backsliding in immunisation, and we’re seeing that happen now and we do expect that the 2023 numbers will be even worse than the 2022 numbers.”

While there had been an “infodemic” of vaccine-related misinformation during the pandemic, O’Brien stressed that lack of access to vaccines was behind the vast majority of children going unvaccinated. 

“The primary reason for unvaccinated people is really related to the ease of access and the quality of services. But this issue of misinformation, hesitancy and people’s understanding of the value of vaccines is very contributory and in some communities, this is a big contribution to people’s behaviour around vaccines,” she acknowledged.

“The reasons for this misinformation, hesitancy or lack of confidence in vaccines is very, very local so we can’t give global recommendations on exactly what to do,” she added.

However, she urged health authorities to listen to communities, and assure local leaders about the “life-saving nature of vaccines and the safety of vaccines”.

“I want to really emphasise the importance of the process that we have in WHO for pre-qualifying vaccines. Our procedure for pre-qualifying vaccines or issuing an emergency use listing is an assurance to countries that those vaccines are efficacious. They’re safe, and they’re manufactured with quality.”

Polio and Hepatitis E

Dr Hanna Nohynek, chair of SAGE

The wild poliovirus type one is only in circulation in a small geographic area of the border between Afghanistan and Pakistan, but SAGE is concerned about the circulation of vaccine-derived polio type one and type two (VDP2) in a number of African countries.

“Improving routine immunisation coverage is at the heart of getting the eradication goals,” stressed Nohynek.

SAGE is also concerned about Hepatitis E, a liver disease that “can be very severe, especially for pregnant women among whom the case fatality rate can be as high as 25%”, she added. 

“In fragile and conflict-affected and vulnerable settings, it’s really important that pregnant women have access to the vaccine,” said Nohynek.

SAGE has recommended a two-dose schedule, which is off label, instead of a three-dose schedule and additional research on hepatitis E vaccination during pregnancy, in people living with HIV and children under 16.

Image Credits: WHO DRC Office Twitter.