RSV
On Wednesday, GSK’s Arexvy vaccine became the first in the world to be approved for use against the respiratory syncytial virus (RSV).

The US Food and Drug Administration (FDA) has approved the first-ever vaccine for respiratory syncytial virus (RSV). The single-shot vaccine intended for use in adults aged 60 or older represents the culmination of six decades of research to protect the world from RSV.

With the green light from the FDA on Wednesday, GSK’s Arexvy vaccine could be available as early as this fall, officials said. The speed of the vaccine’s public rollout hinges on receiving the final stamp of approval from the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices, which will meet in June.

RSV is a virus that kills over 100,000 children under the age of five every year. While RSV’s cold-like symptoms are often viewed as non-threatening to adults, the virus kills around 14,000 adults in the United States every year and has an annual global death toll of 160,000 people.

“Today’s approval of the first RSV vaccine is an important public health achievement to a disease which can be life-threatening,” said Dr Peter Marks, who heads the Center for Biologics Evaluation and Research at the FDA.

The US FDA approval follows its review of the data from an ongoing randomized control trial of nearly 25,000 older adults. Results from the study published in the New England Journal of Medicine in February showed the GSK vaccine reduced the risk of developing lower respiratory tract disease, which is caused by the virus, by 83%. It also reduced the risk of contracting severe lower respiratory tract disorder by 94%.

Dr Len Friedland, director of scientific affairs and public health at GSK, acknowledged the occurrence of several serious adverse side-effects throughout the study, but said they were evenly split between the group that got the vaccine and the one that received the placebo. Researchers would continue to monitor the vaccine’s safety profile as the trial moves forward, he added.

The most common minor side effects observed in the participants were injection site pain, fatigue, muscle pain, headache and joint stiffness.

A battle since the 1960s

Scientists have been trying to figure out a way to combat RSV since the 1960s. Between 1966 and 1968, a promising clinical trial for an early RSV vaccine candidate went badly wrong, killing two young children involved in the trials. Many more children vaccinated as part of the study needed to be hospitalized, with some suffering from more severe forms of RSV as the vaccine backfired.

It wasn’t until years later that scientists discovered that the protein inside the RSV virus shifts between two shapes, similar to the coronavirus SARS-nCOV-2. The shape-shifting nature of the protein meant scientists were trying to hit a moving target. The protein eluded the aim of scientists until 2013 when researchers from the National Institutes of Health (NIH) found a way to freeze the protein in one of its two shapes, allowing the development of vaccines targeted at the now immobile protein.

While RSV has long been a regular virus in the winter seasons, it gained attention when thousands of young children and older adults began filling up hospitals during the summer seasons in 2021 and 2022.

In 2020, most of the world was still under the COVID-19-induced lockdown and following precautionary measures like using face masks and frequently washing hands. As those precautionary measures were lifted, vulnerable groups of people began contracting RSV and ending up in hospitals.

Other RSV vaccines in the queue

The US FDA is set to decide on another RSV vaccine by the end of May. This vaccine is also targeted at older adults and is manufactured by Pfizer. If approved by the FDA, Pfizer’s vaccine will be up for final approval for public use alongside the GSK vaccine when the CDC’s Advisory Committee on Immunization Practices meets in June.

Another vaccine by Pfizer is also awaiting approval from the FDA by the end of August. This vaccine targets infants susceptible to RSV and, if approved, will be administered to pregnant women.

Moderna and Bavarian Nordic are also currently in phase-3 of clinical trials for their RSV vaccine candidates for older adults.

Image Credits: NIAID.

There is widespread speculation that the World Health Organization (WHO) will decide that COVID-19 is no longer a “Public Health Emergency of International Concern (PHEIC)” when its expert group convenes on Thursday.

The 15th meeting of the Emergency Committee for COVID-19 has been convened by the WHO Director-General in terms of the International Health Regulations (IHR).

Fueling the speculation is the WHO’s release late on Wednesday of a 20-page “updated COVID-19 Global Strategic Preparedness, Readiness and Response Plan (SPRP) 2023-2025”.

The document is a guide for countries on how to manage COVID-19 over the next two years “in the transition from an emergency phase to a longer-term, sustained response”, according to the global body.

WHO Director General, Dr Tedros Adhanom Ghebreyesus notes in the foreword that, aside from the usual objectives of reducing the circulation of SARS-CoV-2 and diagnosing and treating COVID-19, the plan adds a third objective: “to support countries as they transition from an emergency response to longer-term sustained COVID-19 disease prevention, control and management”. 

“We do not propose that countries abandon the 10 pillars that served as a foundation for the pandemic response,” adds Tedros. “Rather, the new strategy aligns these 10 pillars with the five core components of equitable, inclusive and effective health emergency preparedness, response and resilience: collaborative surveillance, community protection, safe and scalable care, access to countermeasures, and emergency coordination.”

The focus is on restoring, reinforcing and strengthening health systems, as well as “integrating COVID-19 surveillance and management into that of other respiratory diseases”. 

Long COVID focus

The new plan places a strong emphasis on long COVID, which may affect as many as 6% of those infected with COVID-19. It calls for more research to better understand the post-COVID condition, “including its risk factors and the role of immunity, and to develop methods to better quantify its burden”.

“Although we are in a much stronger position in facing the COVID-19 pandemic, the virus is here to stay and countries need to manage it alongside other infectious diseases,” according to the WHO.

Meanwhile, the WHO’s coronavirus dashboard notes no new COVID-19 cases have been reported in the past 24 hours – although it is widely recognised that many countries are no longer monitoring new infections.

In late March, the WHO Strategic Advisory Group of Experts on Immunization (SAGE) decided that additional COVID-19 vaccine boosters were not recommended for people at low to medium risk of the disease who have been vaccinated and boosted once.

SAGE recommended an additional booster six to 12 months after the last dose for “high priority” people, depending on factors such as age and immuno-compromising conditions.

On Monday, the US announced that it would end COVID-19 vaccine mandates for international travellers, health workers in hospitals and federal employees on 11 May.

“While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary,” said the White House.

Image Credits: Vital Strategies.

Dr Anthony Fauci, former Director of the National Institute of Allergy and Infectious Diseases, was attacked and vilified during the COVID-19 pandemic.

The conspiracy-based anti-science attacks on scientists and vaccines that proliferated during the COVID-19 pandemic in the US are likely to have chilling, long-term effects on biomedicine, according to Professor Peter Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. 

The biggest casualty may be childhood vaccinations, leading to a surge in diseases that had been almost eradicated such as measles, whooping cough and polio, writes Hotez in FASEB BioAdvances journal.

Polio cases in New York city and an outbreak of measles in unvaccinated children in Ohio already bear this out.

Confidence in childhood vaccines has already dropped considerably during the pandemic, with 35% of US parents now opposed to routine immunisations being required before children could enroll in school, according to a Kaiser Family Foundation report in December 2022.

Meanwhile, a 2021 survey by YouGov found that less than half (46%) of parents who supported the Republican Party were in favour of childhood vaccines being mandatory for school attendance in contrast to 85% of Democrats. Overall, support for vaccine mandates dropped by 4% between 2020 and 2021.

The effect of Republican politicians’ promotion of anti-vaccine conspiracies has already been seen in COVID-19 death statistics, with Republican (“red”) states recording much higher death rates.

“During Delta, COVID-19 vaccinations exhibited over 90% protective immunity versus death and yet an estimated 40,000 Texans died because they declined to get immunized,” writes Hotez, who is based in Texas.

“Nationally, that number of unnecessary deaths was approximately four to five-fold higher. The analyses from The New York Times and healthcare data specialist, Charles Gaba, reports that those deaths overwhelmingly occurred in conservative or Republican-majority states. Moreover, the ‘redder’ the state in terms of voters, the lower the immunization rates, and the higher deaths climbed.”

Hotez cites multiple examples of Republican politicians discrediting the effectiveness and safety of COVID-19 vaccinations during the Delta and Omicron waves. The US has one of the highest global COVID death rates per capita in the world, with 1.1 million deaths.

“Thousands of Americans in conservative states believed it all, and they paid with their lives. They fell victim to a coordinated campaign of antiscience aggression. Its three major elements included anti-vaccine and antiscience rhetoric from federal and state elected officials, together with amplification nightly on Fox News (and other news outlets) and academic cover from a few universities and extremist think tanks,” argues Hotez.

Demoralising effect

Professor Peter Hotez has been harassed by anti-vaccine protestors.

Hotez, who has been subjected to persistent harassment by anti-vaccine protestors, warned that the anti-science movement will “demoralize biomedical scientists”, many of whom already report that they “live in a climate of fear” as they face an “avalanche of abuse” via emails, social media and physical confrontations.

The “unprecedented distrust of scientists” could result in a reduction in federal support for the National Institutes of Health (NIH) and other biomedical research institutions, and discourage university students from pursuing careers in the sciences. 

“I am regularly targeted online through social media and emails, as well as phone calls and even in-person confrontations. The Florida Governor has disparaged me on Fox News, despite my correct predictions regarding COVID-19 in his state, while about Dr Anthony Fauci he stated his desire to have ‘that little elf’ thrown “across the Potomac [River]”.

Fauci, the former director of the National Institute of Allergy and Infectious Diseases and chief medical advisor to the president from 2021 to 2022, has faced almost constant derision and death threats during the pandemic.

Urgency to respond

Given that the rise in anti-science sentiment could undermine the future of biomedical science in America, Hotez argues that it is essential for both US President Joe Biden and the Office of Science and Technology Policy (OSTP) to respond. 

“The political drivers for the assaults on biomedical science and scientists remain unclear, but they resemble those directed against climate science and scientists that began a decade ago,” he notes.

“During the 20th century, science and scientists were attacked as part of larger ambitions for authoritarian control in the USSR and elsewhere. The motivation may be similar.”

Possible responses include “a federal plan to preserve science and protect American scientists” and a legal defence fund for scientists

As the pathogen causing the next pandemic may have both high mortality rates and transmissibility “we must find ways to limit the flow of disinformation to ensure that life-saving vaccines and therapeutics do not go unused as they did in America during the time of COVID-19,” he urges.

“More complicated is how we limit the spread of disinformation in a free and open society committed to first amendment rights. This concern must be balanced with the stark reality that anti-science aggression is causing a substantial loss of human life, possibly in the hundreds of thousands according to some estimates,’” he adds.

“All indications so far suggest that the biomedical scientific community has not prepared adequately, and there are few plans to counter these politically motivated attacks.”

Image Credits: flickr/The White House. Official White House Photo by Andrea Hanks.

A doctor at Ifakara District Hospital in Tanzania treating a malaria patient

The momentum from last week’s World Malaria Day needs to translate into more resources to address the global funding shortfall to achieve 2030 malaria targets.

Since the turn of the century, global partnership and sustained investment have completely transformed the fight against malaria – preventing two billion malaria cases, saving 11.7 million lives, and putting eradication within reach. 

Figures like these were very much in the spotlight last week as World Malaria Day took centre stage to highlight the progress that’s been made in the fight against malaria so far, as well as the further steps that still need to be taken. But it’s vital that the conversation about malaria eradication is sustained beyond this important day, and action is increased to deliver against this goal. 

As we now look towards the World Health Assembly at the end of the month, we hope to see an increased commitment to ending this deadly disease.

As more countries approach malaria elimination, progress has started to slow in the countries with the highest rates of the disease – mostly in sub-Saharan Africa. Low coverage of existing tools, emerging biological threats, and a shortfall in global malaria funding prevents these countries from reaching global malaria targets. 

In 2021, malaria cases increased to 247 million, contributing to over 600,000 preventable deaths, according to the World Malaria Report 2022.

Converging biological threats

Between 2021-23, global funding for malaria control has fallen by $4.8 billion – less than half the total funding required to deliver national programmes.

This is a tragic situation and a situation that remains precarious. At the same time, half the world’s population lives at risk of the disease.

With several biological threats converging and threatening to increase the spread of malaria, the stakes are higher than ever. The growing threat of insecticide and antimalarial resistance will have significant implications on the effectiveness of the tools at the heart of efforts to end malaria, such as nets, treatments, insecticide spraying, and diagnostic tests.

While many countries pledged $15.7 billion to the Global Fund’s Seventh Replenishment last year (which serves as a significant source of funding for tackling malaria), in addition to the Presidential Malaria Initiative and the Bill and Melinda Gates Foundation, this was far less than needed to accelerate the fight against these diseases and achieve global targets. Countries are now faced with the enormously difficult task of increasing malaria control measures with even less funding than before.

Now is not the time for the world to step back from our commitments to end malaria – quite the inverse.

New tools but shortage of resources

An infant receiving the RTS,S malaria vaccine in Ghana in 2019. New malaria vaccines hold the promise of significantly reducing childhood infections and severe malaria cases.

The good news? We have new tools to respond to these threats. Existing investments in R&D have produced the most robust pipeline of malaria interventions in over a decade to address emerging threats and transform the fight against malaria. But many of these proven interventions are waiting to be implemented at scale. Countries will not reap the rewards of these investments without financing the scale-up and rolling out of these innovations where they’re needed most.

We now have a window of opportunity to galvanise action and accelerate progress to achieve 2030 targets, but countries must act fast. They continue to work tirelessly to hold the line against malaria by implementing innovative approaches to tailor and deliver lifesaving tools to the most vulnerable and hard-to-reach. Still, without sufficient investment and efficient use of available resources, they risk losing further ground.

Global leaders, countries, the private sector, and all partners must urgently deliver bold malaria control and elimination investments. Only by innovating and bringing new tools, implementing new approaches targeting and tailoring the most in need, and bridging these funding gaps can we accelerate progress against this age-old disease and ultimately achieve a zero-malaria world.

Dr Corine Karema is Interim CEO of the RBM Partnership to End Malaria. 

Image Credits: Peter Mgongo, WHO.

TDR and Dr Garry Aslanyan are preparing to launch a third season of his Global Health Matters podcast with a new list of guests to help tackle core issues in the global health community.

Aslanyan is the executive producer and host of the podcast.

“We have learned a lot in terms of how we can produce episodes and how best to engage our audience,” said Aslanyan, a public health professional with TDR, the Special Programme for Research and Training in Tropical Diseases co-sponsored by UNICEF, UNDP, the World Bank and the World Health Organization.

He said, “We know that the podcast has struck a chord with many audiences and has received continuous feedback from listeners. In addition, we receive emails and voice messages from people who write reflections on some of the episodes.”

“I believe it is always important to convene people and spread new ideas, and Global Health Matters is doing that,” said Tom Wien, the founder of The Dignity Project, a campaign for more respectful international development.

The podcast’s purpose is three-fold; on the one hand, Aslanyan hopes to reduce some of the silos in the global health discourse. In addition, the goal is to offer a more in-depth reflection on core issues and to bring them to light in new and different ways. Finally, there is a focus on inspiring listeners.

“Through listening to the podcast, those already engaged in global health but maybe not in a specific area can learn from the guests – what they have accomplished, their unique approaches – and bring some of the lessons into their work,” Aslanyan said.

“From my perspective, this podcast can give visibility to scientists in fields and regions of the world who normally wouldn’t have such visibility,” said Prof Aída Mencía-Ripley. “It is a wonderfully diverse platform.”

This year, as the world moves beyond COVID-19, Aslanyan said the podcast would play an additional role: Making sure the health community remains focused on pandemic preparedness and does not “go back to business as usual” without putting steps in place to improve public health.

In his first year, Aslanyan hosted guests from across the public health community and worldwide, such as Rose Leke, founder of HIGHER Women Consortium Cameroon, who spoke about her work to research and fight malaria. He talked with Natalia Pasternak, founder of Instituto Questão de Ciência in Brazil, who advised how scientists can set up science communication institutes in their countries.

And there were many more.

“Surprisingly and to my delight, several senior global health leaders in countries, at WHO and other agencies wrote me and said they listen to the podcast,” Aslanyan said.

As TDR prepares for season three, Aslanyan said he would keep what works and expand based on what he has learned. For example, he said there will be more sharing of personal experiences. In addition, aside from the regular 10 episodes, there will be four in-depth, reflective episodes with one-on-one interviews with global health thinkers and leaders who have foresight into future challenges.

Most recently, Aslanyan hosted a live Twitter Space conversation and said he plans to integrate more of those into the mix.

“The podcast will not be the same because I am not the same person as I was two-and-a-half years ago,” Aslanyan noted. “I have many responsibilities in my job, and I never thought any of them would be a podcaster.”

Read all about the podcast here.

Leaders of the US conservative Christian group Family Watch International travelled to Uganda and met with Uganda’s first lady, Janet Museveni and other government officials to encourage the passing of the Bill.

Uganda’s Parliament passed a revised Anti-Homosexuality Bill on Tuesday, retaining executions for certain same-sex activity and introducing harsher penalties for some categories of ‘offences’.

Ugandan President Yoweri Museveni had declined to sign into law an earlier version of the Bill after the Deputy Attorney General (DAG) had advised him that it would be open to various legal challenges, sending it back to Parliament to be tightened up.

The inclusion of the death penalty in particular would leave the bill open to legal challenge in a country that has effectively ended the use of capital punishment, wrote DAG Kaafuzi Jackson Kargaba in a letter to the president.

However, Parliament has voted to retain the death penalty for “aggravated homosexuality” – defined as sex with a child or disabled person or while living with HIV. A 20-year prison sentence for “knowingly promoting homosexuality” has also been retained.

However, the Bill no longer makes it a crime to simply identify as LGBTQ and people are only obliged to report homosexual activity if a child is involved.

The Bill had the support of all but one of the MPs, many of whom have persistently equated homosexuals with paedophiles.

Speaker Anita Among took issue with Kargaba for pointing out the flaws in the earlier Bill and when he tried to explain his position, she refused to allow him to speak.

“Today Parliament has once again gone into the history books of Uganda, Africa and the world and clearly brought up the issue of homosexuality, the moral question, the future of of children and protecting families,” said Among.

“We have a culture to protect. The Western world will not come to rule Uganda,” she added.

Ironically, however, US conservative Christian groups have been pushing for the legislation since 2014 when a “kill the gays” Bill was passed but never implemented after being overturned in a legal challenge, and Among has been part of the high-level government officials meeting with these groups, including the Arizona-based Family Watch International.

“This legislation… is here to erase the entire existence of an LGBTQ person in Uganda, but also it radicalizes Ugandans into hatred of the LGBTQ community,” LGBTQ activist Frank Mugisha told MSNBC’s Rachel Maddow in an interview on Monday.

Since the previous Bill was passed a month ago, hate crimes and violence against LGBTQ people have risen sharply, according to the Human Rights and Awareness and Promotion Forum (HRAPF), a legal aid organisation.

In addition, police have arrested people on suspicion of being LGBTQ, according to HRAPF.

The Bill goes back to the president to be signed into law amid intense pressure for him not to from the US and European Union in particular.

pandemic
Countries across the world show first signs of significant recovery of health systems after the pandemic.

Three years after the COVID-19 pandemic began, health systems across the world are showing signs of recovery from its negative impact, with fewer countries reporting on scaling back delivery of essential health services as compared with 2020-21.  

Disruptions to the delivery of essential health services had almost halved by the end of 2022 when compared with the same period in 2021.

The interim report of the fourth Global Pulse survey on the continuity of essential health services during the COVID-19 pandemic released by the World Health Organization (WHO) on Tuesday stated: “The key informant survey results indicate that while essential health service disruptions persist in almost all countries across the globe, health systems are showing the first notable signs of recovery and transition beyond the acute phases of the pandemic”. 

This round of the survey covered responses from 125 countries and concluded that an average of 23% health service types (“tracers”) were disrupted in the last quarter of 2022 (October to December). Taking into account 84 countries that participated in all four rounds of the pulse survey, the service disruption decreased from 56% in the third quarter of 2020 to 23% in the fourth quarter of 2022.

Health services
Level of service disruption across 27 tracer services in 84 countries submitting responses to all four survey rounds

Some of these tracers include 24-hour emergency care, emergency surgeries, rehabilitative services, family planning and contraception, antenatal care, and routine facility-based immunization services. 

While an overall reduction in disruption to the delivery of health services is evident, countries still reported disruptions to around 25% of the tracer items covered through the survey. 

Dr Rudi Eggers, WHO Director for Integrated Health Services, acknowledged the recovery in delivery of health services and added, “But we need to ensure that all countries continue to close this gap to recover health services, and apply lessons learnt to build more prepared and resilient health systems for the future”.

Significant recovery since 2021

The data collected and presented in Tuesday’s report shows a significant positive change from the previous editions. 

The third Global Pulse survey report published in February 2022 stated that over 90% of the countries faced ongoing disruptions in delivering essential health services to its people due to the pandemic.  

In the third edition, healthcare workforce issues emerged as one of the major barriers to delivering essential services in over 35% of the countries that responded to the survey. Additionally, around 53% of the countries reported disruptions in delivering primary health care services and 38% of the countries reported disruptions in the delivery of community care services. 

The disruption in the delivery of primary health care services decreased to 26% in the latest edition of the report and the disruption in providing emergency life-saving care decreased to 16% in the latest edition. 

In the latest report, over 70% of the countries reported that they have successfully budgeted for and integrated COVID-19 services including case management, vaccines and diagnostics in their health systems. However, when it comes to managing post-COVID-19 conditions, only 60% of the surveyed countries stated having budgets and integration strategies for it. 

Around 80% of the countries still reported having at least one challenge in increasing access to one or more essential COVID-19 tool. 

Health services
Bottlenecks to scaling up access to essential COVID-19 tools (n=83)

Countries eye long-term preparedness and resilience

The report also poins out that countries have institutionalized some of the innovative practices that were born out of necessity during the COVID-19 pandemic, like telehealth consultations. 

Around 75% of the countries also reported an increase in their budget allocation towards bolstering and preparing their health systems for the long term. 

Image Credits: MSH, World Health Organization (WHO).

South Sudan’s Minster of Health, Elizabeth Chuei, being vaccinated at Juba Teaching Hospital with a vaccine delivered by COVAX.

By the end of 2022, COVID-19 vaccines delivered by the global vaccine access initiative, COVAX,  helped to avert 2.7 million deaths across 92 lower-income countries, according a new report based on modelling by researchers from Imperial College London.

COVAX’s biggest success was in low-income countries, where its vaccines were responsible for three-quarters of all deaths averted, with 73% of COVID deaths averted in Africa from COVAX vaccines. 

Between January 2021 and December 2022, COVAX delivered 1.9 billion vaccine doses to countries supported by the Advance Market Commitment (AMC), a financing mechanism where doses were largely funded by donor governments to countries that could not afford them.

By the end of 2022, over half the populations in AMC countries had received their full primary vaccines, according to the report, which was released on Tuesday by the global vaccine alliance, Gavi, one of the four key COVAX partners.

The report was released at the start of a two-day “global stocktake” of COVID-19 vaccine delivery, being held in Ethiopia. One of the aims of this meeting is to ensure that COVID-19 services are integrated into primary healthcare.

The modelling is an extension of earlier research published in The Lancet by researchers from Imperial College’s MRC Centre for Global Infectious Disease Analysis.

They explain their methodology thus: “A mathematical model of COVID-19 transmission and vaccination was separately fit to reported COVID-19 mortality and all-cause excess mortality in 185 countries and territories.

“The impact of COVID-19 vaccination programmes was determined by estimating the additional lives lost if no vaccines had been distributed.” 

COVAX vaccines offloaded in Abuja, Nigeria.

India vaccine export ban

COVAX’s vaccine supply was sharply curtailed in April 2021 when India, battling a severe COVID-19 outbreak, prevented the Serum Institute of India (SII) from exporting any of its vaccines. SII was to have been COVAX’s main supplier.

As a result, by the end of 2021, COVAX vaccines had contributed to a quarter of vaccine doses in the AMC countries, averting around 857,000 deaths averted – or 13%.

In a collosal understatement, the report acknowledges that “arguably more deaths could have been averted had access to doses not been hindered and had countries received them at scale earlier”.

However, while COVAX’s global market suffered from the export ban, the SII vaccines “contributed significantly to India’s coverage gains that year, which saw more than 850 million people receive at least one dose, with 617 million receiving the complete primary series in 2021”.

India conducted the world’s largest domestic COVID-19 vaccination campaign, and the SII vaccines – 80% of which had been destined for COVAX – averted “an estimated 3.6 million deaths in 2021 alone”, according to the report.

‘A ship built as it set sail’

Describing COVAX as “a ship that was built as it set sail”, the report identifies ”key learnings” in how equitable vaccine access can be achieved as fast as possible for low-income countries and African economies.

To avoid delivery delays, COVAX advocates for: 

  • Increased regional supply resilience and manufacturing capacity of life-saving interventions, such as vaccines, particularly across Africa. 
  • Transparency by manufacturers regarding their order books so that when delays occur or supplies are limited, it is possible to determine when countries that are unable to afford doses are in danger of disproportionally missing out. 
  • Contingency funding and surge capacity to enable global and regional health agencies to pivot during a global health crisis and mount a rapid global response.
  • Mechanisms for equitable access to pandemic products like vaccines, therapeutics and diagnostics to be in place before “disaster strikes”.
  • Global mapping of existing health solutions, mechanisms, networks, expertise, policies, frameworks and tools, including those created during COVID. It lists the Emergency Use Listing of health, indemnification and liability agreements and the No-Fault Compensation Scheme as examples.
Gavi’s Aurelia Nguyen

“When COVID-19 hit us, there was no playbook to handle what would become the deadliest global health emergency in 100 years,” said Aurélia Nguyen, Gavi Chief Programme Strategy Officer, and former COVAX managing director.

“The rapid actions of COVAX, which by the end of 2022 had averted 2.7 million deaths, show us how essential a coordinated, multilateral global response is. It also shows the importance of ensuring equitable access to vaccines is built in from the very beginning in any future effort, as many more lives would have been saved if vaccines had reached vulnerable populations earlier.” 

COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, set up to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines.

COVAX is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi and the World Health Organization (WHO), with UNICEF as the key delivery partner for the vaccines.

Image Credits: UNICEF, NPHCDA.

About 30% of Tanzania’s artisanal gold miners are women.

GEITA, TANZANIA—As the morning breeze sweeps across a rugged mining site at Tanzania’s northwest Sabora village, Judith Nyakeke sits under a huge acacia tree, briskly sorting pieces of rock with her bare hands ready to wash.

“This is a tough job but it can be quite rewarding,” she says.

The 39-year-old mother of four, who has been working as a miner for 13 years, adeptly shaking a giant mesh sieve to filter sand from the crushed ore. 

She then wades into a muddy stream to wash the silt encrusted with gold in the water.

Then she goes to her home to mix it with mercury to get a hardened amalgam which she burns on an open flame to distil the mercury and get purer gold ready to sell.

As the amalgam is sizzling on a heated pan, it emits toxic fumes, that waft past Nyakeke’s 12-year-old daughter, Jane, who squats nearby to look.

“People say mercury is a dangerous substance, but I have been using it for many years without any harm,” says Nyakeke, who has a slight stammer.

 Nyakeke’s quest for survival has taken her to the hazardous depth of artisanal gold mining in Tanzania’s northwestern Geita region where men, women and children are jostling to eke out a living.

“I don’t worry too much about health problems. My focus is to put food on my family’s table and educate my children. Other things, God will take care of them,” she adds.

Toxic substance

Mercury is a toxic substance that attacks the central nervous system. Exposure to the shiny liquid metal may cause neurological problems, including impaired coordination, slurred speech, memory loss, and life-long disability, medical experts say.

The toxic substance can cripple the cardiovascular and immune systems, attack kidneys and affect the gastrointestinal tract and lungs.

Mercury poisoning, with symptoms that include twitching, tremors and blurred vision, may also reduce women’s fertility and cause miscarriages, according to doctors at Tanzania’s Muhimbili National Hospital.

Mercury poisoning, which the doctors call “the invisible epidemic”, is hard to detect and can be potentially harmful to children.

In Sabora village, some female miners strap their small children onto their backs when mixing or burning mercury, not knowing that they are exposing them to toxic fumes.

Across Tanzania, hundreds of men women and children are toiling in hazardous goldmines,  exposing themselves to grave health risks.

Although small-scale gold mining is a vital source of income for rural communities in Tanzania – Africa’s fourth largest gold producer – experts say it is hazardous because miners use toxic substances to obtain gold.

A Health Policy Watch investigation in Geita shows that the miners who touch mercury with their bare hands are oblivious to the grave health risks.

Labour-intensive work

Up on the hill at the impoverished Sabora Village, half a dozen men with flashlights strapped on their foreheads emerge from a ground pit, carrying buckets filled with rocks.

Armed with heavy-duty chisels, the miners say they spent six hours crushing the rock to get fist-sized pieces. Then they pass it on to female colleagues who sort and wash them in the river.

Dressed in a dazzling African Kitenge outfit meticulously patterned with blue and yellow marks, Nyakeke and other women crush the ore into smaller fine particles, sort grade and wash them.

Judith Nyakeke right, and her colleague washing crushed rocks encrusted with gold.

The use of mercury in these makeshift goldmines also has a devastating effect on the environment as it seeps into the food chain, causing birth defects, neurological disorders even death, according to Nasra Semgomba, an environmental health expert at Tanzania’s Ministry of Health.

The unsafe disposal of mercury in Tanzania has created a toxic mix in the country’s river system exposing people downstream to serious health risks due to water and fish contamination, she added.

“Small-scale miners should not at all use mercury for processing gold, it is  pretty dangerous for their health,” Semgomba said.

Despite her warning, Health Policy Watch saw artisanal miners in Geita cutting trees, diverting waterways and reshaping the land in their desperate search for gold. While the miners are struggling to eke out a living, they are also disposing mercury through the air, water, and soil. 

Wider problem

Artisanal miners sieving gold encrusted rocks

Across Africa, men, women and children work in labour-intensive artisanal gold mines to eke out a living. Approximately 12% of gold production worldwide comes from artisanal mining. Globally there are 15 million artisanal gold miners, working in 70 countries.

Pushed by sheer poverty, artisanal gold miners in the east African nation often suffer chronic intoxication.

The investigations conducted by Health Policy Watch in Tanzania’s northern Geita region and in the southern highlands of Mbeya shows the miners routinely burn mercury-gold nuggets at their homes, exposing themselves and their families to hazardous fumes.

Some of the miners in Geita told Health Policy Watch that they know the risk involved but believe they are immune to the adverse effects of the liquid metal as they have been using it for a long time without feeling any side effects.

“This is my 11th year as a miner. I have been using mercury without any harm,” said Martin Kulwa, a small-scale miner in Geita.

The miners use mercury for gold extraction because it is cheap and can easily be obtained. While developed nations have adopted safe, cleaner alternatives for gold extractions and have enforced tougher rules for mercury use, African authorities often turn a blind eye to the health risks posed by mercury, citing low capacity and a lack of expertise to deter its use.

Despite efforts to ban mercury use for gold extraction, the toxic liquid is still being widely used by small-scale miners in Tanzania.

“I don’t think there is political will to ban the use of mercury since it is a big business in this country despite its harmful effects,” said Rubera Mato, Professor of Environmental Engineering at Ardhi University in Dar es Salaam.

Child labour

In its 2013 report, “Toxic Toil: Child Labour and Mercury Exposure in Tanzania’s Small-Scale Gold Mines,” Human Rights Watch revealed shocking details of children working in unlicensed small-scale gold mines in Tanzania, risking their lives due to exposure to mercury.

The global rights watchdog said young children are lured to work in the gold mines in the hope of a better life but often end up in the vicious circle of danger and despair.

Tanzania has long been criticised by environmental and civil society groups for its lax regulations to deter child labour.

“Our policies on health and environment are in shambles. We need clearcut policies and laws to deter environmental hazards” said  Zuhra Ahmed, an environmental Activist at Tanzania’s Youth Biodiversity Network 

Estimates of mercury usage vary from between 13.2 and 214.4 tonnes in Tanzania every year, with the approximately 1.2 million artisanal miners being the largest number of users. Between 10% and 20%  of all the gold produced in Tanzania is produced by small scale miners, about 30% of whom are women, according to government data.

Global treaty

Globally the Minamata Convention, a global treaty to protect human health and the environment from the effects of mercury that came into effect in 2017, requires countries to develop national action plans to reduce and eliminate mercury use in artisanal and small-scale gold mines.

But unlike other nations, Tanzania has done almost nothing to regulate the import or use of mercury which causes birth defects, neurological problems even deaths as people consume tainted fish, Ahmed said.

Dotto Benjamin, Chief Mine Inspector in Tanzania’s Vice President’s office (environment) denied the allegations, saying the government has been working to eliminate the worst practices, particularly the open burning of amalgam and processing of mercury-contaminated tailings with cyanide to recover gold, as well as raising awareness on the effect of mercury and promoting alternative technologies.

“A national action plan has been developed to meet the requirement of the Minamata Convention and serves as a national framework for fostering sound management of mercury use and where possible eliminate its use,” Benjamin said. 

United Nations human rights experts in Geneva recently reiterated their call for an end to the trade in mercury and its use in small-scale gold mining.

Marcos Orellana, UN Special Rapporteur on toxics and human rights, recently urged nations to address human rights violations related to the use of mercury in small-scale gold mines and protect the environment by prohibiting its trade and use in such mining.

“In most parts of the world where mercury is used in small-scale gold mining, the human rights of miners, their families and communities, often living in abject poverty, are increasingly threatened by mercury contamination,” he said.

Maria Kemilembe, left, preparing a gold-mercury amalgam before it burning

Indigenous peoples are particularly affected by the destruction and pollution of their territories, deforestation, loss of biodiversity and contamination of their food sources, according to Orellana.

“In order to more effectively combat human rights violations related to the use of mercury in small-scale gold mining and protect the environment, states and the Convention should prohibit the use and trade of mercury in such mining. This will be an essential step towards strengthening other elements of the Convention and making them more effective,” he said.

Asha Kisena, a resident of Nyang’wale village in Tanzania’s Geita region looks older than her 43 years. Her sun-parched skin and the repairs to her tattered dress declare her poverty.

Kisena has been working as a miner for many years, but recently her husband, George, noticed she was sick.

When she showed up at a district hospital in Geita in March, she couldn’t walk, her speech was slurred and she couldn’t walk and was not able to feel her hands.

Shortly after being admitted, Kisena fainted and was hospitalised for many weeks.

Her husband said doctors discovered that his wife’s desperate condition was caused by mercury poisoning.

“She is still sick and we don’t have much hope that her condition will improve,” George said.

But for Nyakeke, there is little choice: “This is my livelihood, I am under no illusion I can quit my job anytime soon,” she said

Image Credits: Kizito Makoye.

Malawi’s Minister of Health, Khumbize Kandodo Chiponda (center wearing cap) visits Machinga District Hospital vaccine store.

BLANTYRE, Malawi – Key Malawian key stakeholders have given the nod for the country to ratify the African Medicines Agency (AMA) treaty, the country’s Ministry of Foreign Affairs and International Cooperation has confirmed.

The AMA is being established as a specialised agency of the African Union (AU) dedicated to improving access to quality, safe and efficacious medical products in Africa.

Malawi would be the eighth African country to sign the AMA Treaty in the southern and eastern region of the continent following Kenya’s signature in February 2023.  Significantly, however, the region’s biggest economic powerhouse, South Africa has yet to sign the treaty. 

However Malawi officials say that they are now keen to follow Kenya’s recent lead. Chimwemwe Chamdimba, Head of Programmes for Africa Medicines Regulation Harmonisation (AMRH), said the signing of the AMA Treaty by Kenya is an important milestone for the continent towards operationalising the Agency.

“The step that Kenya has taken to sign the Treaty gives us hope that, very soon, their Parliament will look at the documents of ratification. This is an exciting time for the continent as we see the first-ever continental medicines agency coming into being. This will ensure the African people access to quality-assured medical products and promote the pharmaceutical sector growth across the continent,” she said.

Chamdimba said African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD) is providing technical support for countries to ratify the treaty and also operationalise the treaty.

“We have developed guidance notes and briefs for countries to use in the ratification process. We have also developed an overarching AMA Country Engagement Strategy which we are currently updating to use in providing support to countries. We have been organising advocacy and training sessions for member states on AMA ratification. We are available for any member state requiring technical and advocacy support.”

Economies of scale

Following Kenya’s signing, some 35 of the AU’s 55 member states have now come out formally to support the AMA treaty – either by signing it, ratifying it, or both.  That makes Malawi one of just 20 countries not yet signed.

 

Dr Evelyn Gitau, Director of Research and Related Capacity Strengthening at the African Population and Health Research (APHRC), says that, in principle, Africa needs economies of scale to make the African pharmaceutical manufacturing industry grow and be sustainable.

“We need to grow our pharma, vaccines and diagnostics industries. We have been relying on imports, been engaged in outbreak or pandemic response. No global market has grown without industry protection, usually in the form of tariffs or other barriers protecting domestic manufacturing. Africa can’t get away with this. It needs to implement the African Continental Free Trade Area. There is need for internal continental mobilisation to leverage the population as part of reaching scale,” she noted.

Gitau however urged for the need for continental harmonisation, including “regulatory frameworks to ensure that what is good enough in one country is good enough in the next country”. 

African countries also each have to deal with different regulators including the European Medicines Agency and the US Food and Drug Administration or World Health Organisation  Performance Quality and Safety to access parts of the medicines markets, and AMA would assist to streamline this, Gitau added.

Kenya became the 31st country to sign the Treaty in February, while 23 other countries have already ratified and are parties to the Treaty.

Senior Advocacy Policy Officer at PATH Kenya, John-Paul Omollo, urged all the remaining AU member states to ratify the AMA in order to achieve a harmonised regulatory system, and to catalyse the pharmaceutical manufacturing ecosystem. 

“AMA will also ensure regulatory convergence and reliance which promotes faster introduction of new and advanced medical products into the market hence quicker access by patients at a lower cost because the final cost of accessing medical products is a composite of time taken and fees paid during regulation of such products,” Omollo observed.  He notes that while the treaty may have been signed by Kenya, it still has to be ratified by the parliament. Following ratification, the treaty instrument is then deposited with the African Union as the final step. 

“I am supporting the Government of Kenya in instituting the process. So far, the documents are to be tabled in parliament for debate. Once approved in parliament, it will be taken for signing by the President. Then the Ministry of Foreign Affairs will submit the instruments of ratification to AUC. It’s only after this that we will be considered fully ratified,” he explained.

Malawi’s commitment 

African Medicines Agency/Countdown Gauge of Treaty Support as of 1 May 2023

Malawi Ministry of Foreign Affairs and International Cooperation spokesperson John Kabaghe said that a number of internal processes, however, still need to be completed prior to signing and ratifying a treaty instrument, including consultations and synergizing the obligations under the treaty with existing government policies, have been finalised.

“So far, experts have recommended that Malawi should ratify the treaty. The obligations under the instrument have been thoroughly checked by the Ministry of Foreign Affairs and there is an indication that Malawi will sign it without reservations,” he told Health Policy Watch.

Kabaghe disclosed that all obligations under the treaty are achievable in the context of Malawi laws and government policies.

“Final preparations of having the instruments signed are underway and it will be deposited very soon,” he said.

Maziko Matemba, the Executive Director for Health and Rights Education Programme, says AMA has the potential and opportunity to enable Malawi to build skills and expertise including manufacturing of medicines.

“Drug shortages have been a major issue in Malawi. Malawi has been struggling to access affordable medicines that it can sustain buying with its budget. If we have AMA established, it may give countries like Malawi bargaining power for the benefit of their citizens,” he said.

There is no deadline for countries to ratify the Treaty of the AMA, Chamdimba revealed, but countries are encouraged to ratify it as soon as possible to benefit from its services.

“We need to move together as a continent in harmonising the regulatory environment, which is important for ensuring access to quality-assured medical products to our population,” said Chamdimba. 

“We cannot wait to provide this human right to our citizens. The time is now for the AU and its Member States. We do not want to leave any country behind in this journey,” she stated.

The AMA Treaty was adopted by the AU Assembly on 11 February 2019 and a minimum of 15 member states are needed to ratify the AMA Treaty in their national parliaments, for AMA to come into force. So far 33 of the AU’s 55 member states are now aligned with the AMA treaty. 

Track the ratification and operationalisation of the AMA treaty here:

Image Credits: Geneva Design/Health Policy Watch .