pollution
Air pollution in Delhi, India.

New evidence that exposure to air pollution can potentially contribute to obesity in women has emerged from a study by the University of Michigan

“Women in their late 40s and early 50s exposed long-term to air pollution—specifically, higher levels of fine particles, nitrogen dioxide and ozone—saw increases in their body size and composition measures,” said Xin Wang, epidemiology research investigator at the University of Michigan School of Public Health and the study’s first author. 

By cross-referencing the residential addresses of the 1,654 US women participating in the study with hybrid air pollutant concentration estimates from 2000 to 2008, the data showed exposure to air pollution was linked with higher body fat, body mass index, and lower lean mass.

But it is not all bad news. The study found that while body fat increased by 4.5%, high levels of physical activity were an effective way to mitigate and offset the effects of air pollution exposure.

Pollution and obesity: a growing link 

With an unprecedented increase in body weight issues worldwide over the last decades, numerous studies have sought to understand the complex and varied causes of obesity – and this is not the first to explore the link to air pollution.

In 2019, researchers at the University of California at Santa Barbara published the first study estimating the causal effect of air pollution on body weight based on data from 13,226 adults in China from 1989-2011. 

This period of study is unique for its historical backdrop. Across the years of the study, China’s economic explosion contributed to a rise in fine particulate matter concentration by 70%. During this time, China’s average BMI increased by 11%, while overweight and obesity rates increased from 8.57% to 32.83% and 0.48% to 4.9% respectively.

“Our study suggests that the cost of air pollution on overweight and obesity is non-trivial,” the authors state. “Although the effect’s magnitude is smaller than studies focused on other economic [and socioeconomic] variables, it is in the same order of scale.”

The International Journal of Obesity also highlighted the potential effects of ambient air pollution on child obesity development but noted evidence is still scarce.

“Early life exposure to air pollution may be associated with a small increase in the risk of developing overweight and obesity in childhood, and this association may be exacerbated in the most deprived areas,” the journal notes. “Even these small associations are of potential global health importance.”

The most striking results came from a study conducted by the Lung Care Foundation and Pulmocare Research and Education in India. The results found that while 39.8% of the children in Dehli, one of the world’s most polluted cities, were obese or overweight, this was true for only 16.4% of children in Kottayam and Mysuru, cities with significantly better air quality.

As studies continue to deepen our understanding of the toxic effects of fine particulate matter (PM2.5) on human health, the silent threat posed by polluted air has revealed itself to be more multifaceted than previously known – and extremely deadly.  

With 99% of the global population breathing air beyond the World Health Organization’s recommended quality limits, an estimated nine million deaths are caused by modern air pollution sources every year. 

New evidence of the adverse effects of air pollution is emerging at a rapid clip, but despite the economic and health implications, progress on the policy front remains slow.

Image Credits: Ella Ivanescu/ Unsplash, Wikimedia Commons: Prami.ap90.

Cancer
More than 1,500 scientists, medical specialists, NGO and civil society representatives, ministers of health, high-level United Nations representatives and people living with, or affected by, cancer are expected this week at the World Cancer Congress 2022.

A lack of expertise in geriatric oncology means that cancer in older adults is often confused with other signs of ageing and diagnosed too late.  Dr Sonali Johnson sets out a blueprint for addressing this barrier – one of the many topics to be discussed at the World Cancer Congress, hosted by the Union for International Cancer Control in Geneva, 18-20 October.

Cancer is a disease for which older adults are particularly at risk as the cells of the body are more likely to turn cancerous as a person ages, primarily as a result of greater exposure to risk factors (though this exposure can be reduced by adopting early a healthy lifestyle). In 2020, over 50% of all cancer cases were among people aged over 65 – nearly 10 million out of a total of 19.3 million – and this proportion will grow further in the coming decades, with the fastest increase occurring in low and middle-income countries (LMICs).

The treatment of cancer is more complex for older adults with co-morbidities, requiring an integrated approach. Yet a lack of expertise in geriatric oncology at different levels of the health system means that cancer in older adults is often diagnosed late as early symptoms are sometimes considered to be signs of ageing. Cancer is more complicated and invasive to treat successfully when it is detected at a more advanced stage.

Age isn’t everything

IUCC
More than half of all people who have cancer are over 65 years old, and this number is predicted to rise as populations age globally. Yet, many health systems are not prepared to address the specific needs of this population.

Older adults are not a uniform group and age alone is a poor predictor of an individual’s health. They can have widely varying physical and mental health at a similar age, with the presence or not of co-morbidities. They may or may not have a strong social support network. They may have considerable or, on the contrary, very limited financial means. Each of these factors will shape if and how an older adult engages with the health system, therefore their preferences and needs should be individually assessed. 

To do so effectively, we need to improve our data on the prevalence of co-morbidities amongst adults aged over 65. Many health policies have been developed and implemented with partial information and in silos, addressing diseases separately. There is an opportunity here for cross-sectoral and multisectoral coordination and integrated approaches that lay the groundwork for patient-centred care.

There is also a need to train health staff in geriatric care to correct the misconceptions that often surround health and ageing – stereotypes, assumptions and prejudices that mask the diverse nature of older populations and the contributions of older adults to society.

Patient-centred care also means removing age limits in clinical trials and the inherent biases in research programmes to make them more inclusive. Currently, doctors and regulators may have little precise knowledge of how older adults react to certain treatments or how cancer medicines may interact with other medications they are taking, since these have not been tested.

Countering misperceptions that older adults themselves may have about clinical trials (e.g. fear of mistreatment, being used as a ‘guinea pig’) is also essential to improve access to services and research. Other limitations also need to be addressed, such as hearing or transportation difficulties.

Only if older adults are proportionately well represented in clinical trials and research can doctors have more insight into the efficiency and side effects of cancer treatments for people over 65.

Caring for older cancer patients is a surmountable challenge

Cancer
Estimated increase in cancer incidence and mortality (2020 data: Globocan / 2030 previsions: AIRC)

The Union for International Cancer Control (UICC) has made cancer and ageing a focus area of its work, supporting the advocacy efforts of UICC member organisations in LMICs working to improve access to cancer services and care for older adults

Initiatives in El Salvador, Guatemala, Kenya, Mongolia and Tajikistan have been set up in partnership with Sanofi, to improve the training of healthcare practitioners in geriatric care; include cancer and ageing strategies in national cancer control plans and universal healthcare packages; ensure cost-free access to cancer medicines for people aged over 65, and increase the availability of palliative care specifically tailored to the needs of older adults.

To improve cancer care for older adults at the international level, the International Society of Geriatric Oncology has developed the Top Priorities Initiative to identify global priorities for progress and development in geriatric oncology and translate these priorities into tangible actions.

The American Society of Clinical Oncology (ASCO) has issued recommendations for geriatric assessments, a tool to understand an older person’s physiological and socioeconomic situation to inform the most effective and appropriate course of care.

These are being adopted by several health systems, for instance in Chile, where the Arturo Lopez Perez Foundation (FALP) created an oncogeriatric unit to provide a comprehensive geriatric assessment of older adults with cancer.

Caring for older adults is not about prolonging life at all costs – and it is not an insurmountable challenge. Neither does it necessarily involve investing significantly in additional resources or diverting resources from other priorities.

It is, ultimately, about ensuring that the clinical expertise exists to identify the specific needs of older adults and offering them the same opportunities for diagnosis and treatment as other populations enjoy, in line with their wishes and particular situation.

Sonali Johnson is Head of Knowledge and Advocacy at the Union for International Cancer Control (UICC), which is hosting the World Cancer Congress in Geneva, 18-20 October.

Demonstrators outside the World Health Summit protest that lack of climate action during a speech by German Chancellor Olaf Scholz Sunday evening

BERLIN – The first World Health Summit co-sponsored by the World Health Organization (WHO) started off with a siren call to climate action – literally – as activists disrupted the ceremonial plenary attended by German Chancellor Olaf Scholz by repeatedly setting off fire alarms 

Outside the posh Hotel Berlin venue,  activists plastered the doors with scientific papers on climate change’s health and environment impacts while a handful staged a sit-in, as police cordoned off the area.

“How many scientific papers are pasted on this building where Olaf Scholz is speaking, telling about the climate crisis and the health crisis?” said one protestor in a post on the demonstration.  “How many things did we do before coming here?”  

Added another protester: “Governments, including the German one, have not defended the climate safe zone. Now there is no plausible way to limit global heating to below 1.5°C.”

Airport delays of Africa CDC Acting Director also provoke storm

Earlier, Africa Centre for Disease Control Acting Director, Dr Ahmed Ogwell, protested at being delayed by German border guards at Frankfurt airport. In a series of tweets, Ogwell said that he had been “mistreated” at Frankfurt Airport by immigration guards who “imagine I want to stay back illegally. My attendance of the @WorldHealthSmt is now in doubt. I’m happier & safer back home in Africa.”

The incident provoked a small storm on social media, including  US Assistant Secretary for Global Affairs, in the Department of Health and Human Services, Loyce Pace,

Pace, also in Berlin for the WHS event, offered an unusually personal description of the treatment she had also experienced as an African American diplomat at border crossings, including Frankfurt´s.  

There was no reference to the incident at the official opening Sunday evening, which Ogwell did not attend. Asked by Health Policy Watch for comment,  a WHS spokesperson confirmed that Ogwell had arrived in Berlin, adding: 

“We consider the situation of Dr Ogwell to be very concerning and we hope that the situation clears up quickly. Dr Ogwell’s voice and expertise, and that of the Africa CDC, are of the utmost importance and are essential to the World Health Summit,” the spokesperson said. 

“It is absolutely critical that all WHS 2022 participants from Africa and all other countries are treated with respect. …WHO and the World Health Summit are both dedicated to the well-being of all people, the key to achieving better health for all lies in collaboration and open dialogue. This is what WHS 2022 stands for.”

However, in the early hours of Monday morning, Ogwell confirmed on Twitter that he had returned home:

Meanwhile,  Yassen Tcholakov, attending the WHS on behalf of the World Medical Association,  suggested: “Maybe we should simply change where global conferences are held. If Europe and North America are unable to act as hosts maybe they shouldn’t be any longer.”

Most elaborate Summit to date 

German Chancellor Olaf Scholz addresses the World Health Summit

As the first WHS to be co-sponsored by the WHO, this year´s summit is the most elaborate to date, with several thousand participants in attendance, along with Pace, Germany´s Chancellor, and most of WHO’s senior staff from around the world on hand. 

Ironically, the African Union is also one of the co-sponsors of the three-day summit, with Senegal’s president Macky Sall, current chairperson of the African Union, offering a video-taped address.

Former Africa CDC director, Dr John Nkengasong, now the US Global AIDS coordinator, appeared in person where he was honoured at the opening ceremony as the recipient of an award for his global public health career of service.  

UN Secretary-General Antonio Guterres also addressed the opening plenary session, calling on participants to make more sustained investments in a healthier world. 

“Wealthier countries and international financial institutions need to support developing countries to make these crucial investments,” said Guterres in a pre-recorded address to the gathering.   

The climate crisis also received a nod from the high-level speakers, with Sol noting the ¨interdependence, between climate change, food crisis and public health.¨

“We should take one message from the protestors…It is an emergency,” said Axel Pries, WHS president at the close of the ceremony.

WHO takes global health to a new level 

WHO´s Dr Tedros Adhanom Ghebreyesus calls on countries to take global health to a new level.

WHO´s Director-General Dr Tedros Adhanom Ghebreyesus called upon world leaders to “take global health to a new level” in a three-pronged approach that would include approving a new pandemic accord; developing new tools to finance and respond to global health crises, and; taking a more preventive approach to health, including by embedding health promotion and disease prevention into areas ranging from urban transport design to finance.  

Tedros also denounced critics of the proposed new pandemic accord.  Those naysayers include some conservative American media celebrities who have tried to claim that a pandemic agreement would lead to an erosion of sovereignty: 

“The claim by some that this accord is an infringement of national sovereignty is quite simply wrong,” Tedros said. 

¨It will not give WHO any powers to do anything without the express permission of sovereign nation-states. If nations can negotiate treaties against threats of our own making, like nuclear, chemical and biological weapons, tobacco, and climate change, then surely it makes sense for countries to agree on a common approach to a common threat that we did not fully create and cannot fully control – a threat that comes from our relationship with nature itself.¨

COVID-19 and Ukraine undermined have undermined decades of progress

Fire alarms set off by climate protestors disrupted the ceremonial opening of the World Health Summit.

Together, the COVID-19 crisis and Russia´s invasion of Ukraine have undermined decades of progress in global health, said Sandra Gallina, the European Commission´s director general of health and food safety.

But looking out at the plenary room packed with over 1200 participants, including hundreds of others in overflow rooms, she added: ¨I have never seen such a crowd for health. We must require robust international rules, including a pandemic agreement. We are stretching our hands out to others to join us in this effort to  deliver a more equitable global health order.¨ 

From diagnostics to air pollution – WHS agenda is ambitious

Rosamund Ado-Kissi-Debrah speaks about the 2013 death of her daughter, Ella, from air pollution at a session on communicating about environment and health at the World Health Summit.

Already in the first day of the conference, the agenda´s menu was huge reflecting perhaps a pent-up appetite for the kinds of thematic debates that cannot as easily take place in the halls of WHO’s governing body, the World Health Assembly, where governments not global health experts set more of the tone.  

Workshops and seminar sessions ranged from the more upstream topics, such as the architecture of pandemic response, to the more familiar ground of  HIV/AIDS, air pollution, and on down to the nitty-gritty of improved diagnostics. 

While COVID has drawn tremendous attention to the importance of equitable access to vaccines and treatments, access to fast-changing technologies remains deeply pockmarked with inequalities, And that poses problems for future outbreak response, said Bill Rodriguez, executive director of the Geneva-based Foundation for Innovative New Diagnostics (FIND). 

Many health systems have yet to ensure access to reliable tests at ¨point of care¨, including self-testing for billions of people around the world, Rodriguez said at a session co-organized by the Konrad Adenauer Foundation and the German Health Federation. 

¨It’s about using tests in your daily life (protecting families and relatives),¨ Rodriguez emphasized.

Another high-profile session, a “Ports to Arms Approach to Access” discussed the successes and shortcomings of the Access to Tools Accelerator (ACT-A) – and whether a ¨supercharged¨ ACT-A could still play a role in future pandemic response.  

The ACT-A initiative, much vaunted by WHO at the start of the pandemic as a truly multilateral effort to ensure equity, has become a focus of debate between those who still tout its achievements and critics who say it was birthed with a paternalistic taint, which ultimately failed to ensure faster and fairer distribution of vaccines, treatments and tests across the developing world.   

Polio eradication gets major Gates Foundation commitment

Longstanding challenges such as polio eradication also got a boost. Notably, the Bill and Melinda Gates Foundation pledged some $1.35 billion to the Global Polio Eradication Initiative, which has seen serious setbacks ranging from new outbreaks of wild polio virus in Pakistan and Africa to a rash of vaccine-derived polio cases extending from New York to Jerusalem. 

The Gates Foundation announcement, following a commitment from Germany for $35 million to polio, was, however, an ironic reminder of the continued distortions in the public health finance landscape,

Despite the ambitious new vision embodied in the World Bank´s new Financial Intermediary Fund (FIF), the scale of the Gates Foundation commitment, as compared to that of Germany, was also a striking reminder that the world´s largest foundations and philanthropies are still carry an outsized load, as compared to governments, when it comes to global health finance,  

¨A reminder of who calls the shots in public health,¨ tweeted one WHS participant, Katri Bertram, acerbically, with the hashtag, #Followthemoney.

https://twitter.com/KatriBertram/status/1581695368987045888

 

Image Credits: Elaine Fletcher/Health Policy Watch , @nicoledepaula, Elaine Ruth Fletcher .

Vaccine deliveries by the global COVAX facility.

Midway through last year, the head of the Africa Vaccine Acquisition Task Team, Strive Masiyiwa, angrily accused the global COVID-19 vaccine acquisition platform, COVAX, of misleading African countries about its ability to procure vaccines for them.

Masiyiwa’s bitter remarks came after months of Africans watching Europeans and North Americans being vaccinated against COVID-19 while no vaccines were available for them – even if their governments had the money to pay for them.

By the end of last year, a special meeting of the World Health Assembly had resolved to set up an intergovernmental negotiating body (INB) to negotiate an accord to guide future pandemics, and all member states agreed that it needed to be based on equity. The INB is expected to submit a draft accord to be negotiated at the 77th World Health Assembly in 2024.

This week, an independent evaluation of the Access to COVID-19 Tools Accelerator (ACT-A), COVAX’s parent body concluded that “a different model for pandemic response will be needed in future”.

The review – which combined interviews with over 100 key informants, a survey and a review of documents – comes as the World Health Organization’s (WHO) INB is preparing a “zero draft” to kick off negotiations on the pandemic accord. 

The ACT-A comprised three pillars – diagnostics, therapeutics, vaccines (COVAX) and a fourth cross-cutting pillar, the Health Systems and Response Connector (HSRC), which was viewed as a flop. 

COVAX ‘too ambitious’

Interestingly, the review’s main criticism of COVAX is that its global scope as the key vaccine-purchasing agent for the world was “too ambitious” and that a “more targeted approach” would have been more useful. 

This observation is based on the failure of high-income countries to go through COVAX to buy its vaccines, meaning that COVAX was “unable to play the market shaping role it first envisioned”. 

The crux of any successful pandemic accord will be to ensure that wealthy countries don’t hoard all the available diagnostics, therapeutics and vaccines to fight the next killer pathogen – an almost impossible task.

Instead of expecting wealthy countries to subject their procurement to a global body, it might be more effective for a future pandemic body to “focus on a smaller set of lowest-income countries”, according to the review.

Despite the criticisms, COVAX’s performance in improving access to COVID-19 vaccines in the 92 Advanced Market Commitment (AMC) countries was ranked 7.5 out of 10, the highest survey rating.

By 15 September, it had delivered 1.72 billion doses although massive vaccine inequalities persist. 

Barbados receives 33,600 doses of COVID-19 vaccines, its first shipment through the COVAX facility, in April 2021

Unsuitable operating model

Almost two-thirds of respondents thought that ACT-A’s operating model should not be replicated, citing problems including “insufficient accountability, limited meaningful engagement of low- and middle-income countries (LMIC) and regional bodies, and an insufficient focus on delivery”.

Prioritising speed and using existing global health agencies to respond to the pandemic had “compromised accountability and transparency”, according to the review. 

“Insufficient manufacturing capacity, unhelpful member state responses to COVID-19, and issues around ‘last mile’ implementation were the three factors that had the biggest impact on ACT-A’s ability to deliver on its targets,” according to survey respondents. 

Civil society organisations and academics listed the lack of technology transfers and the management of intellectual property as the most significant challenges. 

“Going forward, a new platform should be established that involves all key R&D partnerships and coordinates R&D across product types and diseases,” the review recommends.

Three-quarters of survey respondents supported joint resource mobilisation instead of uncoordinated fundraising.  ACT-A raised $23.5 billion, two-thirds for COVAX, but fundraising was too slow, and respondents supported a pandemic advance commitment facility with access to credit. 

The World Bank has already heeded this, and last month it set up the Financial Intermediary Fund (FIF) for Pandemic Prevention, Preparedness and Response (PPR) to “provide a dedicated stream of additional, long-term financing to strengthen PPR capabilities in low- and middle-income countries and address critical gaps through investments and technical support at the national, regional, and global levels”. 

The lack of manufacturing capacity, and weak country health systems are key challenges to address before the next pandemic. 

High-level political leadership

Finally, the review advocates for the creation of a high-level political body to keep pandemic preparedness and response high on the global agenda, track overall progress and provide high-level political guidance. 

Previously, the Independent Panel for Pandemic Preparedness and Response (IPPPR) proposed that a council for pandemic preparedness, made up of senior political leaders, be established under the United Nations General Assembly.

Meanwhile, WHO suggested establishing a Global Health Emergency Council and a Committee on Health Emergencies of the World Health Assembly.

ACT-A was guided by a facilitation council chaired by Norway and South Africa, but the co-chairs lacked global clout and spent a lot of energy appealing to world leaders of wealthy countries to share their pandemic products with others.

Image Credits: Gavi , @CEPI , PMO Barbados.

Dr Mariangelo Simao, WHO Assistant Director General for Access to Medicines, Vaccines and Pharmaceuticals

The Indian government has halted the Maiden Pharmaceuticals plant that produced the cough and cold syrups that WHO says were tainted with toxic chemicals – possibly linked to the recent deaths of some 66 children in The Gambia.

A senior WHO official confirmed that Indian government health authorities had shut down the plant after WHO shared data showing that samples of four syrup formulations, produced by the firm and tested by the global health agency, contained diethylene glycol and/or ethylene glycol, which are toxic to humans.

Speaking at a WHO press briefing on Wednesday, WHO’s Mariangela Simao said that WHO had requested the suspension of production at the Haryana-based facility, following tests at a Swiss and French reference laboratories, which confirmed the contamination in the four syrup formulations.

“WHO did recommend to the drug control controller in India to suspend the manufacturing in the plants that were involved in this incident, and we hear that this has been done and that the production is suspended,” Simao said.

India media reported that the government shut down the plant after WHO shared the formal laboratory results (Certificate of Analysis) with Indian authorities. The government has announced the creation of an expert to further analyse the CoAs provided by WHO, and conduct a state investigation into the reported contamination.

WHO first issued alert on 5 October

WHO alert of contamination found in four Maiden Pharmaceuticals products – issued first on 5 October 2022

WHO first issued an alert about the tainted products on 5 October, stating that laboratory analysis of the medicines which were exported to The Gambia “confirms they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

“To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions,” the global health agency reported.

Speaking to reporters a day later, WHO’s Director General Dr Tedros Adhanom Ghebreyesus said the four cold and cough syrups produced by the firm “have been potentially linked with acute kidney injuries and 66 deaths among children.

“The loss of these young lives is beyond heartbreaking for their families,” the WHO director-general added, saying that the agency was investigating further “with the company and regulatory authorities in India.”

WHO tested the tainted medicines for contamination in Swiss and French laboratories

The Gambian Health Ministry has been investigating an unusual cluster of childhood deaths from acute kidney failure since July. In late September, health authorities concluded that tainted paracetamol or promethazine cold or cough syrups were the most probable cause of deaths in at least some of the cases. The ministry had also investigated high E-coli bacteria levels, due to recent flooding and sewage exposures, as another possible cause.

Following the initial laboratory analysis of the medications in The Gambia, which turned up the chemical contamination, WHO obtained samples of the formulations that had been administered to children who were were hospitalized, and sent them for testing in WHO reference laboratories, Simao said at Wednesday’s briefing,

“23 different samples were sent to our reference labs. One of them is in Switzerland in France,” said Simao. “And then we had unfortunate findings of the four pediatric formulations that had contaminations.

Two products are very old formulations

Two products of the products tested are also “very old” cough and cold formulations, which have known contamination risks in the production cycle, Simao also noted.

“They have been involved in other contaminations that led to serious health problems and deaths since 1930,” Simao added. “It’s a very well known history of diethylene glycol we call it DEG, and ethylene glycol we call it EG – they should never be in anything that human beings ingest.”

There is now “a very in-depth investigation of these deaths by the government of The Gambia, by international partners including WHO, who are supporting the investigation,” she said.

But separate from the investigation into the precise cause of the children’s deaths, “once we detect these products [DEG and EG] in a medicine or something that people will ingest… they should be banned from the market.

“WHO has procedures and one of them is the global medical alert that aims to inform national regulatory authorities when we notice problems with a product, and to also inform the public.

“And also we have to raise the alert in terms of [the possibility that] this product may be circulated in other countries. The information we received from the drug controller in India was that dispatches were manufacturer exclusive for the danger but we don’t rule out the possibility that through unregulated markets that it has reached other countries.”

She noted that several other countries in the African region have in turn issued their own alerts “and are proactively doing surveillance, trying to identify if these products are in the market.”

Meanwhile, she said, WHO is “working very closely with the Indian authorities for the full investigation into the manufacturing process itself and the ways this product reached the market.”

Specifics of WHO warning

The four Maiden Pharmaceutical products specifically called out in the WHO alert include:  Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

“To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” WHO said adding, “Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.

“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death. All batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities. The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.”

Substandard medicines a major problem in Africa

Substandard medicines are a widespread problem in Africa and parts of South-East Asia.  According to one recent estimate, in some parts of Africa, up to 70% of medicines may be either fake or substandard.

There are widespread hopes that the pending establishment of the Africa Medicines Agency (AMA) could help counter this longstanding trend by harmonizing drug regulatory review and approvals across the continent – thereby strengthening the capacity of poorly-resourced countries to supervise its medicines markets.

So far, some 33 of the African Union’s 55 member states have either signed and/or ratified the treaty on the African Medicines Agency. Just this week, South Africa’s cabinet announced it would submit the treaty to its parliament for ratification. The Gambia is one of the 22 countries to have neither signed nor ratified the agreement.  See related AMA coverage here,

African Medicines Agency Countdown

 

Image Credits: WHO, World Health Organization .

(From L-R) Olivier Dessibourg (moderator), Arnaldo Correia de Medeiros, Soumya Swaminathan, Jeremy Farrar and Scott O’Neill, at the GESDA Summit session Wednesday on Wolbachia control of dengue disease.

A nature-based solution that could help reduce the rising global burden of disease from dengue fever is looming on the research horizon. But more studies are needed before the World Health Organization could recommend a broad scale-up of the approach, WHO’s chief scientist said on Wednesday.  

WHO Chief Scientist Soumya Swaminathan summed up her conclusions on the research to date into Wolbachia bacteria as a dengue control tool at a panel event hosted by the Geneva Science and Diplomacy Anticipation Summit. The 2022 GESDA Global Summit is taking place this week from Wednesday to Friday.  

Source: https://ourworldindata.org/grapher/dengue-incidence

“Safety is quite the primary thing for us…making the recommendation is one thing and using and applying it is another. Of course, the WHO’s role is to provide evidence-based guidelines in as timely a fashion as possible, but if there isn’t good evidence backing it, the [WHO] guideline developing group does not feel comfortable,” Swaminathan said.

The discussion on Wolbachia at a session on Controlling Vector-transmitted Infectious Diseases was among a number of future health strategies showcased at the three-day summit, which drew together some 1200 scientists, diplomats and other expert participants from around the world. 

This year’s agenda also includes discussions around the future potential for artificial intelligence, organoids and other synthetic biology approaches to address disease pathology and pave the way for new disease control solutions, from organ transplants to mood disorders.  

Science that makes no sense today, may make sense tomorrow

Sir Jeremy Farrar, director of Wellcome Trust, at the GESDA session

“Science that makes no sense today may make sense tomorrow,” said Sir Jeremy Farrar, the director of Wellcome Trust, who appeared with Swaminathan at the vector control control panel on the opening day of the GESDA conference. 

Farrar  described the work on Wolbachia, led by  Dr Scott O’Neill, founder of the World Mosquito Programme as the kind of pathfinding research that GESDA aims to identify and amplify – accelerating the long journey to real-world results.

 “GESDA wasn’t in existence when Scott (O’Neill) started his work. But if it had been, this would be a case study as to why GESDA was important,” Farrar said.  “It was in the last century when this work started, with basic science invested over years and years. It was high risk, it was difficult..no one could see where it was going…It made no sense.” 

A potentially sustainable solution to dengue that took decades to develop

Over the past two decades, the number of dengue cases reported to WHO has increased ten-fold. While estimates of the true rate of infections varies wildly, data by the Institute of Health Metrics and Evaluation (IHME) estimates a burden of more than 50 million cases a year, concentrated in South-East Asia.

Research on the Wolbachia’s potential as a control tool began in the 1980s. But the bacteria’s ability to compete with, and thus curtail, dengue virus transmission in Aedes mosquitoes only came to light around 2009. The experimental technology involves the injection of Wolbachia bacteria into female Aedes mosquitoes. Within the mosquito, the bacteria competes with dengue virus, Zika and other dangerous mosquito-borne diseases, curbing the mosquito’s potential to transmit those viruses to human beings. 

The female mosquitoes also continue to transmit the beneficial Wolbachia bacteria from one generation to the next within their eggs. Although not normally found in Aedes aegypti mosquitoes, Wolbachia is found in some 50% of insects in the world, and thus considered safe for humans and the environment, according to the researchers.  

First release in Australia in 2011

Scott O’Neill, founder of the World Mosquito Program and leading Wolbachia innovator

In 2011, O’Neill and his team based at Monash University released the first set of Wolbachia-infected Aedes mosquitoes into the wild in Cairns, Australia. The results were astonishing; dengue transmisison was reduced by 98%. 

Since then, the strategy has been tested systematically in two sites in Brazil, including Rio de Janeiro, three cities in Colombia, Indonesia and Vietnam. 

A study on the Indonesian trial that took place in Yogyakarta on the island of Java, was published in 2021 in the New England Journal of Medicine. Some 42-months post release, dispersion of the Wolbachia bacteria between March and December 2017 led to an 80% reduction in  dengue virus rates across 12 geographic clusters in the city of half a million people.  

Speaking about the trials in the panel discussion, O’Neill also stressed the climate resilience of the strategy, which is a growing concern in a warming world. 

“We found in some locations, extreme temperatures can be problematic and have been documented. Is that going to be a huge problem for the technology?” O’Neill asked.

“I don’t think so because it is not constant temperatures that cause the problem. It is the really blazing hot sun of around 45ºC that causes the problem. That’s usually when we get into more temperate areas…” he said, noting that in tropical areas where the dengue disease burden is the highest, the temperatures are more constant. 

Also piloted in Colombia and Brazil 

Professor Scott O’Neill presents the combined results of trials on Wolbachia control of dengue disease in four countries, at the GESDA Summit session Wednesday.

A pilot in three cities in Colombia, including Medellin, reduced dengue incidence by a whopping 94-97% 20-45 months post-release, Scott said in his presentation. Conversely, the trial in Rio de Janeiro has yielded the weakest results so far, with a 44% reduction in dengue incidence four years after the mosquitoes were released.

Even so, Arnaldo Correia de Medeiros, the Brazilian state undersecretary of health managing a pilot in Rio, stressed the government’s commitment to continue its investment in the Wolbachia method, on which it has already spent over $3 million. 

The trials also required significant outreach – sensitizing communities where the Wolbachia-infected mosquitoes were released not to kill mosquitoes infected with the beneficial bacteria, Medeiros observed.  

“It is important to educate the communities that they do not have to kill these mosquitoes because they are not the bad ones, they are the good ones,” Medeiros said, describing the meetings that were held with health workers and the public “so that they understand that  we are going to release the mosquitoes, and after that we are going to monitor, collect data and do the studies.”

In this dimension as well as others, the multi-country trials already have generated valuable insights critical to broader, real-world use of the strategy: “We need to understand how many lessons we have learnt when we think about [scaling up to] the world,” he said.    

WHO: Still need more solid and diversified evidence  

WHO Chief Scientist Soumya Swaminathan at the GESDA session

The technology has been on WHO’s radar for many years, and its Vector Control Advisory Group (VCAG) has been working closely with Dr O’Neill’s team for some time, Swaminathan said.  

Only last month, WHO concluded a year-long  public consultation on the design of a “Target Product Profile” that would help standardize the widespread use of the bacteria. 

Even so, WHO still needs more evidence on the strategy’s safety and efficacy to make a full WHO endorsement, in the form of a new WHO guideline for policymakers, said Swaminathan, at the panel event.

“Especially in a situation like this where the behaviour of a vector could vary from year to year, depending on the climatic conditions… there are many factors that might actually affect the results of an intervention study,” Swaminathan observed.

“For vector control it is not enough to show that there is a change in the vector behaviour, but it is important to show that there is some epidemiological change in the disease,” she stressed.  

“It also has to be cost-effective, it has to be equitable; we look at many factors before the WHO Guideline group actually recommends (a health innovation).”

And there is no fixed timeline for reaching that endpoint, the chief scientist acknowledged, noting that WHO guidelines development can take years.  

Drawing parallels between the agency’s actions during the Covid-19 pandemic where  emergency decisions were taken too rapidly, with insufficient evidence, and then later had to be corrected, Swaminathan added: 

“Science is interesting, but it also needs to have a public health impact.”

Big up front investments can pay off  

Widespread deployment of the technology would involve heavy up front costs, O’Neill acknowledged. 

However, he underlined that  such investments can also offer large returns. “To implement technology is expensive at the front end and it pays back over time.”

For instance, while Brazil so far has spent $3 million deploying Wolbachia-infected Aedes mosquitoes, to date, the savings in averted social and medical costs have amounted to over $24 million, according to data collected by O’Neill’s team – even at the 44% rate of efficacy demonstrated locally. 

Source: World Mosquito Program

Funding agencies and philanthropies need to look at such benefits-to-costs ratios when making decisions about investments – prioritising choices that will ultimately have the greatest  impact on the ground, Farrar added, echoing O’Neill’s remarks.  

Meanwhile, effective public health action against dengue virus, which has become a kind of poster child disease in many developing cities, could set a precedent for many other important innovations that can benefit health, Farrar emphasized.  

Notably, dengue-infected mosquitoes breed and thrive in crowded informal settlements and urban slums full of standing water and waste sites. As a result, the same forces of driving dengue also impact disease control more generally, and public health, through multiple pathways – from poor housing to the lack of effective water, waste and sanitation systems. 

“Dengue is something which is a harbinger of bigger things that are changing the world like climate, urbanisation, trade and travel…I think to get dengue right will set a precedent for how we get a number of things right,” said Farrar.  

Speaking more broadly, public health practitioners and decision-makers need to develop their own capacity to anticipate and take up new public health technologies in a rapidly changing world:

“Technology is coming and let’s think ahead of how we may use it in the communities. We shouldn’t be thinking of tomorrow but five, 10 and 15 years ahead. Because, at least some of it, we can predict,” Farrar said.  

Also at GESDA: Other futuristic solutions  

Along with the session on vector control, this year’s GESDA summit is featuring a number of other futuristic technologies that could positively impact the understanding of the human body and eventually disease control solutions and public health outcomes. Organoids, synthetic biology, artificial intelligence, data and computational science, brain miniaturisation and brain signal detection all have a place in this year’s agenda. 

  • Defining Health Usage Frameworks for Organoids: Organoids are 3D cell cultures that have the potential to transform the realms of organ transplantation, disease pathologies and drug development. However, the technology is not without its own set of challenges and questions around ethics. 
  • Synthetic Biology: Towards New Geopolitical and Economic Frontiers: Apart from having a potential similar to organoids, synthetic biology also encompasses the power to disrupt the global order and disturb world peace. A public plenary to explore the various implications of advanced technology like this is on the schedule. 
  • Deciphering the role that artificial intelligence (AI) can play in decoding the human immunome, thus opening doors for exploring newer health diagnostics and therapeutics is also on the cards at this year’s summit. 
  • Data and computational systems. These are increasingly being leveraged to enhance the human understanding of climate cycles, population dynamics and their management.
  • Brain miniaturisation and brain signal detection – These technological advancements help humans better decipher neurological patterns and thus address pathologies related to mood regulation and memory. While the concepts have generated a lot of interest and investments in the research community, the GESDA session also looks at policy implications.

Image Credits: Megha Kaveri/Health Policy Watch, Megha Kaveri/Health Policy Watch , World Mosquito Program .

A Ugandan health worker disinfects the boots of colleagues in an Ebola treatment zone. In the absence of an effective vaccine for the Sudan Ebola virus strain, strict sanitation, patient isolation and contact tracing are the sole measures available to fight the outbreak.

The spread of a cholera outbreak to an overcrowded Haitian prison, of Ebola virus to Uganda’s capital city of Kampala, and increased incidence of malaria, dengue, measles and cholera in flood-swamped Pakistan were among the long list of health emergencies needing urgent attention and investments – as compared to the trillions being invested right now in military conflicts around the world, said WHO’s Director General on Wednesday. 

“We are deeply concerned about the outbreak of cholera in the capital Port au Prince and surrounding towns…The surveillance mechanism set up by the Haitian government with the support of WHO and other partners is operating under extremely difficult circumstances as the affected areas are very insecure and controlled by gangs,” said Tedros, speaking at a WHO press briefing Wednesday. “In Uganda, so far there are 54 confirmed and 20 probable cases, with 39 deaths [from Ebola virus]… 

“In Pakistan,  I said last week that many more people than died in the floods could die from diseases in coming weeks… now there is a malaria outbreak in two districts while the incidence of cholera, dengue, measles and diphtheria is also increasing in flood affected areas. But so far international support has not been at a scale or speed needed. 

“Trillions of dollars are being poured into fighting wars around the world.  We continue to ask international donors to invest in saving lives.” 

Cholera in Haiti – security the major barrier to controlling outbreak 

Dr Tedros Adhanom Ghebreyesus speaking at a WHO press conference on Wednesday 12 October.

In terms of the Haitian cholera outbreak – the threat that the deadly disease could spiral further out of control is high, both Tedros and other global health advocates have said, given the severe overcrowding of the country’s prisons, fuel shortages, and continued lawlessness. 

Officially, only 18 deaths have been confirmed nationwide, along with 200+ hospitalizations, since last week’s announcement of the country’s first cholera deaths in three years, according to the Associated Press.

However under-reporting is likely given the civil insecurity that is prevailing.

“The surveillance mechanism set up by the Haitian government with the support of WHO and other partners is operating under extremely difficult circumstances,” Tedros said at the WHO press briefing. “The affected areas are very insecure and controlled by gangs, which makes it very difficult to collect samples and information of cases and deaths.

“In addition, fuel shortages are making it harder to help workers to get to work, causing health facilities to close and disrupting access to services for people who live in some of the most deprived communities,” he added.  

Writing in The Nation, a group of global health experts said that as many as 80 people may have already died of the deadly disease in Haiti’s notoriously overcrowded National Penitentiary over the past week. 

And hundreds more prisoners could die in coming days, warned the experts, led by Partners in Health’s Loune Viaud. They appealed to Haitian authorities to organize a mass prisoner release to ease overcrowding and to international donors for urgent investments in vaccines, medicines, clean water and sanitation.  

“WHO is working with the Ministry of Health and our partners to coordinate the response, including for surveillance, case management, water and sanitation, vaccination and community engagement. But to bring this outbreak under control, we need secure access to the affected areas,” he concluded.  

A senior US official, Brian Nicols, was due to fly to Haiti Wednesday on an official visit, while a State Department spokesman said that Washington is also reviewing an urgent Haitian request for help, including intervention by foreign troops to quell the civil violence, the Associated Press reported. 

In 2010, some 10,000 people died in Haiti’s first cholera outbreak, the worst in recent global health history.  That outbreak was eventually traced to a sewage leak from a base of U.N. peacekeepers, who had been brought there to help after an earthquake earlier in the year. 

Ebola – no vaccines, challenges on ground with community engagement 

Meanwhile, speaking from Uganda, WHO’s Health Emergencies expert Mike Ryan said he had “confidence” in the government handling of the Ebola outbreak – the largest seen there in years.  

However, observers pointed to the fact that the spread of the deadly virus to a major city was a worrisome sign – following a similar pattern seen in the 2014-2016 West African outbreak that left over 11,000 people dead. 

https://twitter.com/Boghuma/status/1579944668456161280?s=20&t=lV4n506eE6NuRQjup7KFxA

The shift of infections to a major city like Kampala is particularly worrisome for public health experts since there is as yet no approved vaccine for the Sudan strain of the virus, the one to have struck Uganda this time.  In comparison, the recent outbreaks in neighboring Democratic Republic of Congo, caused by the Zaire Ebola virus strain, have been quickly squashed by ring vaccination efforts using new vaccines developed since 2016. 

“As with Covid-19, the race is now on to find an effective vaccine: there are two potential candidates from GSK and Oxford, and clinical trials are being launched in the middle of this outbreak,” said global health expert Devi Sridhar, writing in The Guardian.

Emergency meeting of regional health ministers convened over outbreak

The area of southwestern Uganda, which has been the epicenter of the outbreak, is also a concern, located at a major trade crossroads.

“Cases were first detected in the Mubende district among people living around a goldmine. Gold traders are highly mobile, particularly along the busy highway that runs between Kampala, a densely populated and globally connected capital of 1.68 million people, and the Democratic Republic of the Congo to the west,” she noted. 

With no vaccine tools available, public health workers have been forced to rely upon non-pharmaceutical measures, including isolation of infected patients, careful infection control, safe burials and the like.  

On the positive side, the turnaround time for Ebola virus diagnosis has been sharply reduced from 48 to just 4-6 hours, said Ryan. Similarly, people with symptoms of Ebola are presenting themselves at clinics earlier  – but still not fast enough. 

Ministers of health from Uganda and eight neighboring countires also held an emergency meeting Wednesday to agree on a series of joint control measures – to prevent the onward spread of the virus beyond Uganda’s borders – which is regarded as a high risk.

Community engagement in the areas affected remains a problem, he noted, with some people still heavily reliant on traditional medicine – and resistant to undertaking safe burial practices – which forbid family members from gathering closely around and handling the body of a loved one who has died. 

“I think it’s fair to say that the Ugandan government is completely activated,” said Ryan. “But we  need more alerts, we need better infection prevention and control in private and public facilities. 

“We need to really embrace the concept of true community engagement – so that the communities are seeing benefits in the process.”

Image Credits: Photo: Anna Dubuis / DFID, WHO African Region.

The drought in the Horn of Africa has caused famine in Somalia.

Over 90% of appeals for urgent hunger-related funding made through the United Nations humanitarian system were not fully funded in 2021, according to a report produced by Action Against Hunger.

While global funding has increased by 233% over the past decade, overall humanitarian needs are up 500%. 

“This means that 42% fewer UN appeals are being fulfilled,” the report stated.

In an analysis of the response to ‘crisis’ levels of hunger experienced in 2020 in 13 countries, less than 8% of food security appeals were fully funded while none of the appeals for support of water, sanitation, and hygiene (WASH) programs were fully funded.

Moreover, more than six out of ten of hunger-related appeals were not even funded to the halfway point while countries that experienced the greatest hunger crises received less hunger funding (by percentage of appeals filled) than countries with half the rate of hunger.

Michelle Brown, Action Against Hunger USA’s advocacy director, described the findings as alarming and called on the global community for more funding to combat hunger, especially in places where the crises are severe.

“While donors have increased their funding, they haven’t increased their funding to the necessary level to actually meet all of those needs,” Brown told Health Policy Watch. “As needs continue to go up, humanitarian funding continues to go up as well but not at the same level. We’re seeing a really significant gap between what the needs are and what the funding levels are.” 

Moreover, she said the report did not take into account the impact of the Ukraine crisis on food prices and the humanitarian response: “What we’re going to see are even greater levels of need, and for similar funding levels that aren’t able to meet those needs.”

It is still possible to end hunger in our lifetimes

In spite of the burgeoning hunger-related crisis and the worsening risks posed by conflicts and climate change, the report notes that it is still possible to end hunger “in our lifetimes”. This, it said, is based on a number of factors including progress made so far. 

Currently, about 828 million people (one in ten worldwide) are undernourished and 50 million people in 45 countries are on the verge of famine, yet between 2005 and 2014, the number of undernourished people dropped from 806 million to 572 million. This represents a reduction of nearly 30% within the period alone. 

The report also noted that the world has enough food and funding to meet the UN Global Goal of Zero Hunger by 2030. But it warned that this goal cannot be achieved without closing the hunger funding gap.

“We have the ability and we have the compassion that’s needed to finally solve hunger. Right now, especially when you look at what’s happening in East Africa, the needs are enormous and we have an opportunity to save lives. We’ve seen in the past that humanitarian assistance can save lives, it can prevent a famine and…this time around, [we need] to ensure that we don’t find ourselves in a famine situation,” Brown told Health Policy Watch.

Image Credits: UN-Water/Twitter .

AMA Treaty approved by South Africa
South African Health Minister Mathume Joe Phaahla affirms support for the AMA at a February 2022 visit of WHO Director General Dr Tedros Adhanom Ghebreyesus.

In a major step forward for the new regulatory alliance, Africa’s third-largest economy, South Africa is now moving to join the African Medicines Agency. 

South Africa’s Cabinet has approved the signing of the African Union treaty establishing the African Medicines Agency (AMA) and submitted it to Parliament for ratification, according to a government statement on 23 September. 

“Cabinet approved the signing of the Treaty for the Establishment of the AMA and its submission to Parliament for ratification,” the statement reported.

“This will give effect to the treaty that was adopted by the African Union Assembly in 2019. The treaty formally establishes the AMA for the continent. The agency will regulate medical products and improve the safety and efficacy of the medical products for the continent.

“The signing and ratifying of this treaty will advance South Africa’s global and continental commitment toward strengthening the continental regulatory system on its health products,” the statement added.

If the South African Parliament ratifies the treaty, South Africa will be the 34th country to swing behind the AMA since the treaty took force in November 2021 with the ratification of the first 15 African countries to get behind the initiative. 

AMA Countdown – status as of 11 October 2022

Public health officials welcome South African move

Zimbabwean public health specialist Dr Nokuthula Kitikiti, who is of South African origins, described the development as “great news”.  She noted that South Africa’s move holds special relevance since its national regulatory agency is one of the few in Africa that has achieved the milestone of being designated as “maturity level 3” (ML3) by WHO. 

“Smaller and less developed agencies can benefit from their participation in the AMA by building capacity through joint reviews and understanding the process at the South African Health Products Regulatory Authority (SAHPRA) and other ML3 agencies,” she told Health Policy Watch.

As a key regional manufacturing centre for vaccines and the site of the World Health Organization’s (WHO) mRNA vaccine hub, Kitikiti said it is is vital for South Africa to be involved in AMA as Africa builds its vaccine manufacturing capabilities. 

“South Africa also has a vibrant patient and civil society community that I am sure will enrich the continent-wide discussions on how to involve the public and patients in a more meaningful way in health products regulations as the AMA takes shape. We are still very nascent in this compared to other regions. After all, we are all doing this to make medicines safer and more accessible for patients,” she added.

Key country in operationalizing AMA 

South Africa has been one of the big country holdouts on treaty ratification – along with Nigeria in West Africa and Kenya in East Africa. 

 

This is despite pledges from South Africa’s political leadership that it supported the AMA dating back as far as 2017 when the AMA’s first stakeholder consultative meeting was held at the South African historical city of Johannesburg.

Senior South African government officials have repeatedly stated that they had no hesitation regarding being a part of the AMA. In February 2022, South Africa’s Health Minister, Dr Joe Phaahla affirmed the country’s support for the continental-wide medicines regulatory authority, and said the government would sign the treaty.  

“There is no, in principle, hesitation. It’s more operational in terms of making sure that we do sign the treaty on the AMA,” the minister said, during a tour by WHO’s Director General of Cape Town’s new mRNA vaccine R&D hub.

Treaty ratification by parliament remains critical next step for South Africa – also for Kenya  

The front page of the AMA Treaty

Even so, ratification of the AMA treaty by the South African parliament remains a critical step before the deal is sealed. Following that, the treaty ratification then needs to be formally deposited with the African Union. 

Kenya’s parliament has remained stalled on the treaty ratification already for the past five months ever since the cabinet signalled its approval of the treaty in May. 

In Kenya, the National Assembly officially received a memorandum proposing ratification of the AMA in June 2022 but nearly four months later, parliamentarians are yet to vote on the treaty. 

According to the memorandum that presented the treaty to the parliament, the signing and ratification of the treaty by Kenya will “demonstrate Kenya’s commitment to the continent’s collective action to the improved regulation of medicines, medical products and technologies… Ratification will bring about positive consequences both to the country and States Members.”

However, Kenya held national elections in August, leading to a Supreme Court challenge of the election of President William Ruto, whose election was ultimately upheld. The ensuing political uproar, however, likely also delayed the parliamentary move. 

East African countries urged to sign the treaty 

The treaty has long been a topic of discussion in regional African political forums, including at events such as the Commonwealth Speakers and Presiding Officers’ Conference held in November 2021 in Rwanda and attended by both Kenya and South Africa. 

South Africa approves AMA Treaty.
(On right) Amos Masondo, head of the South African delegation to the Commonwealth Parliamentary Conference in Rwanda in November 2021.

At that conference, the leader of South Africa’s delegation Amos Masondo, urged parliamentarians across the continent to “accelerate the ratification” of the treaty.

“Establishment of an AMA [will] help regulate products; help invest more in research and development, [and help countries] to build their own vaccine production while fighting to address vaccine nationalism that disadvantages the African continent,” Masondo said.

Nigeria another holdout – could be a costly delay  

In West Africa, meanwhile, Nigerian global health equity advocate Ifeanyi Nsofor told Health Policy Watch the continual delay in the treaty’s ratification and full implementation could create confusion in the pharmaceutical landscape on the continent as countries that have already signed and submitted the treaty may have a different policy direction from those that haven’t. 

He added that the delay could also have impacts on plans to scale up vaccine manufacturing on the continent.

“Of importance is the way it could delay plans to manufacture vaccines in Africa. Infectious diseases do not care about politics. Ultimately, Africans would suffer from this reluctance. It’s a matter of life and death,” Nsofor told Health Policy Watch.

Lesotho and Mozambique the latest formal AMA entries

In spite of holdouts, the number of countries in Africa that have swung behind the treaty has continued to grow – and now constitutes a two-thirds majority of the African Union’s member states.  

On 1 September, the Kingdom of Lesotho became the latest Member State to ratify and deposit the AMA Treaty instrument.

Prior to that, the Republic of Mozambique also signed the treaty on 8 August but it has yet to ratify the treaty and deposit the ratified instrument with the African Union as per the formal required procedure. 

Regarding the holdouts, the official AU line continues to be “countries have different ratification processes at the national level … However, the AU Commission continues with advocacy efforts to encourage more member states to ratify the Treaty.”

At the same time, AU Special Envoy to the AMA, Michel Sidibé, and the AMA Treaty Alliance (AMATA) are also engaging patient groups, industry, academia and civil society to support the AMA treaty and its operationalization. 

Sidibé, who also is the former Executive Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS), described the success of this approach as reliant on “partnerships with stakeholders across the health ecosystem”.

“It is very important to not lose momentum…We don’t have another way to do it except making sure that we maintain and sustain our advocacy — and we mobilize political leaders,” said Sidibé in one recent Health Policy Watch interview. 

AMA will be enlisted in African Union’s battle against drug resistant microbes 

AMA advocates have continuously underlined the knock-on benefits the new regulatory agency would have in terms of not only harmonising the approval of new medicines – but also thereby ensuring more access to affordable quality medicines. 

This, in turn, can help fight worrisome trends like antimicrobial resistance (AMR) – which the continent has little capacity to track or tackle right now, according to one recent study of 14 countries.

According to a new African Union Framework for AMR Control, the nascent AMA will promote a common scheme for prohibiting the sale of non-standard antimicrobials, whose use can foster drug resistance, backed by post-marketing surveillance. 

In the context of the framework, the AMA will contribute to strengthening laboratories for drug quality control and promote the education of pharmacists in identifying sub-standard or falsified drugs, using innovative tests to measure drug quality, while also encouraging policies that promote the availability of genuine, safe and effective products at competitive prices.

The Framework also promotes collaboration with governmental and non-governmental partners (including community groups) to increase awareness amongst not only clinicians and pharmacists but also veterinarians and animal and crop producers about substandard and falsified antimicrobials.

For full coverage on the development of the African Medicines Agency, see our AMA Countdown Page here: 

African Medicines Agency Countdown

-Kerry Cullinan contributed to the reporting on this story.

Image Credits: @elmimuller, Kenyan Parliament website, South African Parliament.

WHO’s SAGE: executive secretary Dr Joachim Hombach, chair Dr Alejandro Cravioto and WHO’s Dr Kate O’Brien.

Measles outbreaks are escalating in large parts of the world thanks to “backsliding” in national immunisation programmes during the COVID-19 pandemic, the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) on immunization warned on Tuesday.

“There were 25 million children un- or under-vaccinated in 2021,” said Dr Kate O’Brien, WHO’s director of immunization, vaccines and biologicals, warning that many of these children were now at risk of measles, which is “one of the most infectious viruses with somewhere between 12 and 18 people being infected by one measles case.”

“We are seeing an escalating in measles outbreaks. They’re escalating in number, they’re escalating in the number of countries, and they’re escalating in the size of the outbreaks. And so we’re watching the fire coming towards and this … will result in a large number of deaths unless action is taken,” she warned.

“When a critical fraction of a country or community’s population is not immune, and measles is circulating, you’re going to get massive outbreaks,” she said, urging countries to launch catch-up campaigns.

SAGE executive secretary Dr Joachim Hombach warned that malnourished children faced a greater risk of severe measles, and this was a concern given the global rise of malnutrition.

All three vaccines for monkeypox 

SAGE chairperson Dr Alejandro Cravioto

SAGE also recommends the use of all three vaccines currently available to prevent monkeypox, namely the smallpox vaccine, ACAM2000, as well as Bavarian Nordic’s MVA-BN (JYNNEOS) and the Japanese-produced LC16.

“For healthy adults, any of the three currently available vaccines is appropriate,” according to SAGE chairperson Dr Alejandro Cravioto, which marks a change from WHO’s interim guidance that initially warned against the use of ACAM2000.

However, SAGE noted that “for individuals for whom replicating or minimally replicating vaccines are contra-indicated, non-replicating vaccines should be used”. 

It advises pre-exposure vaccination for high-risk groups –  gay, bisexual, or other men who have sex with men (MSM) with multiple sexual partners. 

“Others at risk include individuals with multiple casual sexual partners; sex workers; health workers at repeated risk of exposure; laboratory personnel working with orthopoxviruses; clinical laboratory and health care personnel performing diagnostic testing for monkeypox; and outbreak response staff,” said Cravioto.

SAGE also advises post-exposure vaccination (PEPV) for the close contacts of monkeypox cases​​, ideally within four days of first exposure. 

Lack of evidence about vaccine efficacy

Kate O’Brien, WHO’s director of immunization, vaccines and biologicals

However, SAGE conceded that there was little evidence about the impact of the various vaccines on monkeypox. 

“I want to remind people that we’re at the very beginning of understanding the data on the effectiveness of these vaccines, which have not until this point been deployed against monkeypox and especially in the context of the current outbreak,” said O’Brien.

“We do know that the MVA Bavarian Nordic vaccine is in constrained supply, and we’re also working with countries to understand what their demand is for these vaccines,” said O’Brien.

The WHO is working on “this constrained supply” with affected countries and manufacturers “to understand what the scaling of supply could be, and especially matching that supply up with the demand”, she added. 

“This also has to do with how the vaccines are deployed, as you know there are some countries that have chosen to deploy the vaccines using a fractional dose, which of course is dose-saving,” she added

“Our recommendations are really in the context of this outbreak to contribute to the end of the human-to-human transmission that’s occurring in countries that have not otherwise had monkeypox cases, as well at the same time, providing those same recommendations for countries that have monkeypox cases,” said O’Brien.


According to the latest WHO report on monkeypox, between 21 September and 5 October, 7147 new cases (11.6% increase in total cases) and three new deaths have been reported. 

Twenty-six countries reported an increase in cases, with the highest increase in Nigeria (44.4%). Overall, 39 countries have not reported new cases for over 21 days, the maximum incubation period of the disease. 

The WHO also launched its Monkeypox Strategic Preparedness, Readiness and Response Plan last week which outlines the priority actions needed to stop human transmission of monkeypox, minimize animal-to-human transmission of the virus, and protect vulnerable groups at risk of severe disease. 

COVID bivalent vaccines and Corbevax

SAGE also noted that it was too early for it to pronounce on the efficacy of bivalent COVID-19 booster vaccines, containing the mRNA of the original strain and that of the Omicron sub-lineages.

As a result, it recommended that booster vaccinations four to six months after the last dose, with either the bivalent or original vaccines, would “provide improved protection against currently circulating SARS-CoV-2”.  

It also reviewed the data of Corbevax (BECOV-2) the non-patented vaccine developed by researchers at the Texas Children’s Hospital that is currently being manufactured and used in India.

“SAGE will issue recommendations once the product is listed by WHO for emergency use (EUL),” it noted.