The creation of AMA was in focus at the second International Conference on Public Health in Africa at Kigali, Rwanda
The creation of the AMA was in focus at the second International Conference on Public Health in Africa at Kigali, Rwanda

When it becomes fully operational, the AMA will complement the Africa CDC especially in the area of pandemic preparedness.

KIGALI, Rwanda – Advocates for the African Medicines Agency called on the African Union (AU) and its 55 member countries to speed up efforts to establish the African Medicines Agency (AMA), saying it will strengthen the continent’s preparedness for future pandemics and post-pandemic recovery.

An alliance of health experts, including academics, businesses and patients, said a road map is needed to quickly set up a solid governing structure, create an operational headquarters and appoint a director-general for the AMA, which would become Africa’s second-largest health agency after the African Centers for Disease Control and Prevention (Africa CDC).

The African Medicines Agency Treaty Alliance (AMATA) called for expedited actions on the sidelines of the second International Conference on Public Health in Africa held this past week in Kigali. Some 2,500 public health practitioners attended the new venue for tackling longstanding global health challenges in an African context.

This year’s focus was on ensuring Africa is better prepared to fight future pandemics by expanding disease surveillance, nurturing the vaccine production initiative, and strengthening health systems.

Proponents of the the new agency’s creation, however, argued it, too, is crucial for pandemic preparedness. They said safe drugs, vaccines and other pandemic response tools are at the core of efforts to boost preparedness on the continent.

But they also noted an urgent need to build up the AMA in a way that reinforces the African regulatory ecosystem at national and regional levels. 

A new health extension of the AU

AMA is being created to serve as a specialized health agency of the AU to improve the regulatory harmonization of medicines.

“The COVID-19 pandemic has exposed Africa’s vulnerabilities in ensuring access to vital drugs, and commodities,” said Michel Sidibé, the AU’s special envoy for the AMA, a former executive director of UNAIDS and former minister of health and social affairs for Mali.

Minata Samaté Cessouma, the AU’s commissioner for health, humanitarian affairs and social development, acknowledged that AMA’s headquarters has yet to be officially established despite Rwanda’s selection in July to serve as the host country.

Samaté Cessouma expressed optimism that African countries can working together on the new agency as they have done during the pandemic.

“The response to this pandemic diverted the already scarce resources and threatened some of our success. However, this pandemic has taught us that we can move mountains if we come together,” she said.

Specific demands for the African Union

At the side event, AMATA said AMA also needs to be equipped with sustainable funding and adequate human resources so it can enhance the continent’s health systems.

“The pharmaceutical regulatory processes, procedures, and expectations of manufacturing, market authorization [should be] streamlined to prevent duplication of efforts and delays in access to life-saving medicines and vaccines to all patients,” the alliance said.

It also aims to position the new agency as a pillar of research and supply chains to prevent falsified and substandard medicines reaching patients.

See more about African Medicines Agency Countdown here: 

African Medicines Agency Countdown

 

Image Credits: Paul Adepoju.

South African sex workers and their allies protest in favour of the decriminalisation of sex work.

South Africa is poised to become the first African country to decriminalise sex work following the publication of an amendment to the country’s criminal law for public comment.

South Africa’s Cabinet has approved the publication of the Criminal Law (Sexual Offences and Related Matters) Amendment Bill, which proposes the decriminalising the “buying and selling of adult sexual services”.

South African Justice Minister Ronald Lamola told a media briefing this week that “sex work and related activities has been the subject of considerable debate in South Africa”.

“Sex work is driven by a complex intersection of social and economic factors in which poverty, unemployment and inequality are key drivers,” added Lamola.

South African justice minister Ronald Lamola

“Within the current South African context the debate around sex work has been complicated by high levels of unemployment, crippling poverty, burgeoning numbers of migrant and illegal foreign job seekers, high levels of sexual violence against women, the HIV/AIDS epidemic, drug and substance abuse and targeted exploitation of women engaging in sex work by third parties, authorities and buyers.”

He added that the amendment aimed to reduce gender-based violence and femicide (GBVF) as there was a view that criminalisation of sex work “leaves sex workers unprotected by the law, unable to exercise their rights as citizens and open to abuse generally, not least when they approach state facilities for assistance”.

South Africa has high levels of GBVF. In October the remains of six women who had been brutally murdered were found in dustbins around a motor repair shop. A number were sex workers who had been missing since June.

“I wish we could state that these brutal murders of sex workers in Johannesburg’s inner city are unusual. They are not. The sex worker community mourns the deaths of colleagues on a too regular basis,” said Constance Mathe, coordinator of Asijiki, a coalition of sex worker rights organisations shortly after the murders were uncovered. 

She demanded that the Department of Justice provided a timeline for when it would finalise its decriminalisation of sex work Bill, which had been promised for almost two years.

Asijiki has been lobbying for the decriminalisation of sex work for over a decade, but its efforts were thwarted when a South African Law Reform Commission established to look into the matter, recommended in 2017 that the country retain a totally criminalised legal framework.

“But criminalising sex work has not stopped the selling or buying of sex, nor has it been effective,” Lamola noted.

“If anything, it has led to higher levels of violence against sex workers. In addition, criminalisation affects predominantly women, with the female sex worker usually being the one who is confronted by law enforcement, but the male client isn’t.”

Sex worker rights organisations have hailed the move, with the Sex Workers Education and Advocacy Taskforce (SWEAT) saying that it hoped it would end the “legalised violence” against its members.

 

Image Credits: Sonke Gender Justice.

malaria
Intermittent preventive treatment in Pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is effective in preventing maternal death and reducing maternal malaria episodes.

The Medicines for Malaria Venture (MMV) and African Centers for Disease control signed a Memorandum of Understanding (MoU) on Thursday to providing technical support to African manufacturers of antimalarial drugs that would help bring their products up to WHO-approved standards – thus ensuring wider use of locally-produced drugs on the continent and beyond. 

The move by MMV is the latest development in a growing wave aimed at scaling-up medicines production in Africa in the wake of the COVID-19 outbreak. The COVID pandemic exposed Africa’s over-reliance on imported drugs, estimated to comprise between 70 and 90% of drugs consumed on the continent, lighting a fire under the movement to ensure the continent could guarantee its own medicines. 

Ensuring that African-made products meet WHO standards would also make them eligible for bulk procurement by large, donor driven institutions such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, which recently pledged to source more of its procurement in Africa as well.

“COVID really turned up the heat on a long-running political dialogue in Africa on this idea of not wanting to be caught out, as has happened so many times, as the last one on the train to get served with medicines’,” said George Jagoe, executive vice president of access and product management at MMV. “There’s been 15 years of discussion on the African pharmaceutical manufacturing plan, but it feels like the last two or three years reached the boiling point thanks to COVID.”

Efforts of the African CDC have so far focused on building vaccine capacity. Vaccines are the most high-profile medicine Africa was frozen out of during the pandemic, but the hit to global supply chains also broke many of the continent’s other medical supply systems, leaving many without recourse to treatments.

With the acute vulnerabilities built into Africa’s dependence on foreign-made medicines in sharp focus, governments and industries across the continent began work towards a bigger goal: broader self-sufficiency in the production of medicines that are overwhelmingly imported from Asia, Europe, or the Americas.  

“It became pretty obvious that no one wanted to stop at just vaccines,” Jagoe said.

Malaria is a natural next target for African manufacturing efforts 

Malaria, a disease where the biggest burden is in Africa, is a natural target for such efforts, said Jagoe in announcing the initiative, which would see MMV expertise used to support manufacturers on the continent meet WHO standards for good manufacturing practices.

“Malaria couldn’t be more crystallized to point out the absurdity of a continent utterly relying on others to take care of what is disproportionately an African problem,” Jagoe said. “I think that’s one reason it’s become such a flagship for the larger discussion around African autonomy because it galls African Leadership to be running into this wall over and over again.”

According to the 2021 World Malaria Report, Africa was home to 95% of all malaria cases and 96% of all deaths. About 80% of all malaria deaths in Africa are among children under 5 years and pregnant women. Yet at least 79% of antimalarials consumed on the continent are imported from India and China.

In August, a manufacturing facility supported by MMV and Unitaid became the first African manufacturer to receive prequalification from the World Health Organization for sulfadoxine-pyrimethamine, a life-saving medicine used for intermittent treatment of malaria in pregnancy. Today, of the 375 drug makers in Africa, only five are WHO prequalified, but the Kenya-based facility represented proof-of-concept.

“It shows it’s feasible, that the concept is not rocket science,” Jagoe said. “African companies can continue to grow their capacity to make medicines that meet WHO standards and can be part of the global supply chain.”

Across Africa, the development of national and continental manufacturing capacities for anti-malarials has become intrinsically linked to the question of sustainable planning for its public health systems and crisis preparedness. 

“It’s not just an industrial policy, and it’s not just national pride,” Jagoe said. “These are linked questions for national autonomy and national strategic planning for their public health needs.”

Free trade agreements critical for cost-competitiveness

Health volunteers pick up supplies during a seasonal malaria chemoprevention campaign in Nigeria.

The agreement between MMV and the African CDC also has a trade dimension. The agreement also includes an appeal to AU member states to implement free trade agreements to ease the flow of high-quality, African-manufactured medicines isn’t just about access: it’s a question of cost.

Currently, much of the world’s supply of antimalarials comes from India. China comes in a distant second, but maintains a manufacturing capacity in parallel to its central role in the global pharmaceutical supply chain, and its economies of scale make for cheap production costs.

“Both countries are incredibly cost competitive, and African manufacturers are just starting their engines in a very competitive race,” Jagoe said of India and China’s anti-malarial production. “If on top of that they are hampered by protective or prohibitive tariffs, it’s a double hazard.”

Cost-competitiveness will be important for African companies seeking not just to supply their regions or continent, but to become players on the global market. Global health advocates and organizations – especially in the access to medicines space – have long argued for tariff relief for medicinal products.

Potential benefits include better public health and health outcomes, in turn providing a boost to developing local economies, accelerating the development of private industry, and reducing dependence on foreign-made medicines.

“If you want to give a shot in the arm to African manufacturing, free trade agreements that will expedite and lower the burden of flow of products between and within regions would be a real enabler for these companies to take off even faster,” said Jagoe.

Quality assurance remains a priority, and its systems are evolving

Dispensing medicines on World Malaria Day in Kisumu Kenya.

The question of quality has long dogged medical manufacturing in Africa. A number of major pharmaceutical companies tried and failed to develop manufacturing hubs in the continent in the 1990s, Jagoe noted.  After that, the idea of focusing on African production was effectively shelved. 

At the time, companies cited prohibitive costs and an under-availability of a highly trained technical workforce as making the endeavour to produce at international standards simply too difficult. 

“That was really a majority belief hammered deep into the ground,” Jagoe said. “I heard this for almost a decade.”

Today, as African regulatory agencies and medical manufacturing industries mature, global systems for regulating quality assurance are adjusting to fit the simultaneous need to promote African supply independence, and minimizing the threat of substandard medicines, he said. For instance, a new African Medicines Agency is currently in the process of being created. It is hoped that the AMA can play a key role in both harmonise drug regulatory regimes across the continent, and also combatting fake medicine products.  

Substandard medication remains a serious problem across Africa. WHO estimates that between 72,000 and 169,000 children under five-years-old die as a result of inadequate pneumonia antibiotics every year, while bad antimalarials are estimated to lead to anywhere from 31,000 to 116,000 deaths in Sub-Saharan Africa annually. While the full extent of the problem is unknown, the WHO estimates 1 in 5 medicines on the continent are either substandard or falsified, making the African region home to the highest prevalence of inadequate medications in the world.

The lack of access to necessary medicines and vaccines creates a vacuum often filled by falsified and substandard medical products.

WHO pre-qualification programme – ensures good manufacturing practices for approved products

The World Health Organization’s pre-qualification programme, launched in 2001 under the motto ‘No poor drugs for poor people’, was the first internationally recognized form of approval for quality of medicines production.

Prior to the pre-qualification programme, the US’s Food and Drug Administration and the European Medicines agency were effectively the only sources of authority on this question. The WHO stepping in to undermine this monopoly on quality assurance helped open the door to the expansion of generics medicines production in developing country pharma hubs, including in China and India. 

“In those years and pre-qualification was this remarkable gateway that said, we the WHO will have de facto regulatory blessing so that you the donors can be reassured that a product meets the kind of standards you’d want for anyone in your own countries,” Jagoe said.

Since then WHO pre-qualification has extended its domain. Under a separate programme it also rates and grades national regulatory agencies on a 1 to 5 “maturity” scale. The higher the rating, the higher the WHO’s degree of confidence in the abilities of that medical authority to regulate its own medicines, and issue safety and quality approval for its domestic production facilities.

Under that WHO programme, African countries including Ghana, Nigeria, and Tanzania have already raised their WHO regulatory rating level, creating a benchmark for others to follow.  

“I think what’s going to come out of these maturity level designations is a greater degree of recognition that ensuring the quality standards of medicines can be devolved to national authorities in Africa, which is a really important advancement,” said Jagoe. “We don’t want to relax this standard of what’s quality medicine, but maybe be more open to who can determine that.”

Image Credits: Karel Prinsloo-Jhpiego , Karel Prinsloo/Jhpiego, Munira Ismail_MSH, United States Army , WHO.

COVID-19 vaccine administered in mid January at the Jacob K. Javits Center in New York City, which has been converted into a vaccination site.

As COVID-19 cases are starting to spike around the world once again, a new study published in The Lancet Respiratory Medicine “provides safety assurances to the global population” about fourth vaccine shots.

The study, conducted in Israel, is the first large-scale research into the safety of the additional booster. It comes at the same time as two separate studies conducted in Thailand reaffirm the effectiveness of the additional booster against Omicron and the importance for high-risk individuals of taking any shot – regardless of the type of vaccine. 

As people become eligible for fourth (and in some cases fifth) shots of the COVID-19 vaccine, there has been increased reluctance, possibly because of previous side effects, but more likely because of the absence of sufficient vaccine safety information. 

In the United States, two months after the Centers for Disease Control and Prevention recommended a second booster, only 21.5% of eligible individuals had received the shot. Similarly, in Israel, where the research was conducted, fewer than 900,000 accepted the fourth jab, compared to more than six million who took the first three, despite its availability since the end of last year. 

Only 320,000 Israelis have taken the newly available Omicron-specific Pfizer vaccine.

Tel Aviv University’s Prof Dan Yamin, who led the research, said that the hope is that these safety assurances “can help increase the number of high-risk individuals who opt to receive this booster vaccine and thereby prevent severe outcomes associated with COVID-19.”

Dr Dan Yamin

No increase in side effects with fourth shot

Yamin and his team decided to evaluate the safety of the shot when they discovered there was a gap in the literature, he told Health Policy Watch. While regulatory authorities require large, controlled trials before approving a primary vaccine series, “when it comes to boosters, the regulations are that you don’t really need to show a safety profile in a large dataset.

“We wanted to check it out,” he continued, “and look at these safety concerns.”

In this study, Yamin’s team evaluated the safety profile of taking a second Pfizer COVID-19 booster vaccine using data from both a retrospective and a prospective cohort. The retrospective study looked at what vaccine side effects were reported by doctors and patients. For the prospective study, participants were equipped with smartwatches and the researchers evaluated both what they reported, and also objective, continual measurements being taken by the watches. 

The first part involved analyzing the anonymized medical records of 250,000 members of Israel’s Maccabi Health Services, the second-largest healthcare provider, to understand if there were any short-term “adverse events” from taking the second vaccine compared to taking the first. The team also evaluated if any of the 25 adverse events happened at all.

Of the 250,000 records received, 94,169 people received the first booster and 44,003 were eligible for the second. Of those who were eligible, 17,814 received the shot. Their age ranged from 18 to 104, with the median age of 69. 

“Comparing the 42 days before and after vaccination, the second booster was not associated with any of the 25 adverse events investigated, including myocardial infarction and Bell’s Palsy,” the researchers wrote in their paper. “None of the individuals was diagnosed with myocarditis or pericarditis following vaccination with the second booster.”

The most frequently reported reactions were fatigue, headache, muscle pain, cold and a sore throat. These reactions faded in nearly all participants within three days of receiving the second vaccine. 

Elevated heart rates 

But Yamin said the team did not stop there because sometimes patients experience side effects and may choose not to report them. 

“We tried to challenge the vaccine as much as we could,” Yamin said.

So, they recruited patients who consented to take part in the smartwatch study, so that they could monitor several physiological measures, including heart rate – something that individuals are unlikely to observe for themselves. In addition to the digital monitoring, the mobile application collected daily self-reported questionnaires on local and systemic reactions. 

Some 1,785 participants who received the first booster and close to 700 people aged 18 and older from across Israel who received the fourth shot participated in the study between 30 December 2021, and 22 July 2022. 

“We found no significant differences after inoculation with the first booster compared with the second booster” regarding most events, Yamin noted. That is, except on one data point, revealed by the smartwatches: Fourth shots did elevate average heart rates beyond the baseline — meaning the pre-vaccination rate. 

“We found a significant increase in mean heart rate relative to that observed during the week before vaccination levels during the first three days following the second booster, peaking on day two,” Yamin told Health Policy Watch. “Mean heart rate values returned to baseline levels by day six.” 

Similar trends were observed for other measurements, including HRV-based stress and resting heart rate, he said.

“Previous studies have suggested that even a minor long-lasting increase in heart rate is associated with an increased risk of death,” the authors wrote. “However, in our study, the daily mean difference of heart rate values returned to baseline levels by the sixth day after vaccination, so we do not expect an increased risk by this temporal change.”

Yamin said that an elevated heart rate for a few days after vaccination is not uncommon because when a person’s immune system is working hard, it can lead to a decline in heart rate variability as the body concentrates on the other tasks at hand. He said that from a clinical standpoint, the temporary elevated heart rate in 5 beats per minute observed is not really relevant.

However, he added that “what is clear is that the vast majority of people hospitalized are older and in a high-risk group. There is a vaccine that we found is safe and we highly recommend taking it based on these findings.”

Heterologous, homogeneous vaccines equally as effective

Nearly 7,000 kilometers away from Israel, in Thailand, a separate research team found that taking a fourth shot of any of the COVID-19 vaccines reduces the chance of infection by 75% compared to not taking any vaccine, while a third dose is only 31%.

“The vaccine effectiveness against Omicron infection was comparable across the AstraZeneca, Pfizer and Moderna boosters,” lead researcher Prof Suwat Chariyalertsak, dean of the Faculty of Public Health at Chiang Mai University, told Health Policy Watch.

Prof Suwat Chariyalertsak

Moreover, his research showed that a fourth shot taken less than 90 days before COVID infection provided as much as 4% greater protection than the third dose on its own.

The study drew on a unique active surveillance network established in Chiang Mai, located in Northern Thailand, with a population of 1.6 million. Nearly 100% of citizens received heterologous vaccine schedules – starting with one of the approved Chinese vaccines and then being eligible for additional shots with the AstraZeneca, Pfizer or Moderna COVID-19 vaccines.

In a paper published by The Lancet Regional Health – Southeast Asia, Chariyalertsak and team evaluated the vaccine effectiveness of heterologous third-dose and fourth-dose COVID-19 vaccine schedules during both the Delta- and Omicron-predominant periods. In other words, they tried to see if individuals were equally as protected if they took an AstraZeneca, Pfizer or Moderna booster shot in combination with a previous vaccine. 

They found that effectiveness against Delta infection was minimal after receiving only a single dose of vaccine. A two-dose primary vaccine series had vaccine effectiveness of 63% against Delta. A third dose increased the vaccine effectiveness to 97%.

Regarding Omicron, one or two doses of the vaccine provided little to no protection against Omicron, while three doses increased vaccine effectiveness to 31% and a fourth dose to 75%.

“The vaccine effectiveness of third or fourth doses against omicron infection was equivalent for the three main vaccines used for boosting in Thailand, suggesting coverage, rather than vaccine type is a much stronger predictor of protection,” the researchers wrote. 

No severe outcomes

Perhaps more importantly, Chariyalertsak said, in a separate paper published in the International Journal of Infectious Diseases, they found that severe outcomes were not observed among patients who received a fourth dose after a median of 53 days since the last vaccine dose. Patients who received the third dose 14 to 90 days before the date of testing positive for the virus had the highest risk reduction against severe COVID-19 outcomes – 93%.

“Our paper provides much-needed evidence to support the ongoing national efforts to increase population coverage of booster doses,” the researchers added.

Chariyalertsak said that in Chiang Mai only one or two people who received the fourth dose have entered the intensive care unit or died due to COVID-19. He added that an additional value to the study of a heterologous regime is that people who are hesitant to take an mRNA vaccine can feel confident taking one of the other varieties as their booster. 

“We really want people, especially those who are older or who have other comorbidities, to come for the booster doses – third, fourth or even fifth doses, if the last vaccine shot was longer than four to six months ago,” Chariyalertsak told Health Policy Watch. “Either a booster with a viral vector or mRNA will show the same effectiveness to reduce the severe outcomes and death during this time. 

“There is no need to wait for the future vaccine, such as the bivariant one,” he continued. “Then, it may be too late for them.”

Image Credits: Flickr – Metropolitan Transport Authority, Tel Aviv University.

WHO Director General Dr Tedros Adhanom Ghebreyesus describes imbalance in spending on war and health – and death of his own uncle in ongoing violence in Tigray, Ethiopia

There are emerging hopes that sometime in 2023, WHO can declare that the COVID-19 global health emergency is over, said WHO Director General Dr Tedros Adhanom Ghebreyesus, speaking at a pre-holiday press briefing on Wednesday.  

Meanwhile, however, the world continues to invest some $2 trillion in wars and “killing each other” – but not nearly enough in preparing for pandemics and humanitarian crises like SARS-CoV2 that rocked the world, said Tedros, making a plea for more investment in health, during a detailed ‘year-in-review’ briefing with other top WHO officials at the agency’s Geneva headquarters.

He later told journalists that he had almost cancelled the pre-holiday meeting after recently learning that his own younger uncle had been “murdered” by Eritrean troops during an incursion into Ethiopia’s blood-soaked Tigray region – one of the areas of the world that has been rocked by violence over the past year. Despite a November truce between Tigrayan rebels and Ethiopian government forces, Eritrean forces aligned with Addis Ababa have continued attacks in some areas.

“It was a difficult moment for me. I was struggling, but we went ahead,” he confided just before the end of the briefing.

Against that sobering personal news, however, Tedros’ comments on the declining rate of deaths from COVID, Mpox and in Uganda, Ebola, and struck some upbeat notes as the year comes to a close.    

“At this time a year ago, COVID-19 was killing 50,000 people a week.  Last week, less than 10,000 people lost their lives,” Tedros said. “There is still a lot that all countries can do to save lives. But we have come a long way.  We are hopeful that at some point next year we will be happy to say that COVID 19 is no longer a global health emergency.

“The criteria for declaring an end to the emergency will be among the topics of conversation when the [WHO] Emergency Committee meets in January,” he added.  That date will mark three years since COVID was first declared a “public health emergency of international concern” by WHO on 30 January, 2020, followed by a statement on March 11 that the virus had reached pandemic proportions.  

COVID virus is here to stay; need to manage it alongside flu and RSV 

On left: Mike Ryan, WHO executive director of Health Emergencies

That does not meet that the world has met that mark quite yet, Tedros cautioned: “This virus is here to stay, and more countries will need to learn to manage it alongside other diseases, including influenza and RSV [Respiratory Syncytial Virus], both of which are circulating intensively in many countries. 

Despite the massive global vaccine  roll-out, only one in five people in the world’s lowest income countries have been vaccinated, he added, while COVID diagnostics and treatments remain inaccessible for many in low-income countries, meaning that “the burden of long COVID is only likely to increase.” 

Big blind spots in global surveillance of emerging threats 

Surveillance for Ebola Virus a the border between Democratic Republic of Congo and Uganda – many countries lack funds to effectively track infections and variants.

Surveillance of new SARS-CoV2 as well as other disease threats also remains exceedingly weak in many countries, Tedros said. 

Some countries are even dismantling COVID surveillance systems that they had set up, with WHO support, during the height of the pandemic, because they simply cannot afford the costs, Mike Ryan, Executive Director of Health Emergencies, warned. 

“Many of the systems that we established have in some countries been dismantled,” Ryan lamented.  “Many countries have disinvested in surveillance capacity, disinvented in their genomics capacity because their systems are under such pressure because of the … energy crisis and economic crises.

“We’ve left blind spots on surveillance in different parts of the world,” Ryan added, comparing the disproportionate investments by rich and poor countries in tracking SARS-CoV2 and other emerging threats, to those of a community that puts “100 smoke detectors in one house, and no smoke detectors in the other houses.

“And that’s what we do when we increase the intensity of surveillance and genomics in an industrialized country, while leaving a gap in the South,… which is going to affect not only that country, but the whole world’s ability to react to a new signal.

“That’s the world we’re in right now. So I think we need to be really careful because if we do want to match our [new] vaccines to the circulating strains, we still have work to do, and it’s not just on vaccine development.  It’s  not losing sight of surveillance.”  

Renewed call to China to share data and research on SARS-CoV2 origins

Chinese and WHO-International team present findings February, 2021 in Wuhan, China on theirjoint study of the SARS-CoV2 virus origins – in Wuhan briefing 9 February. Since then, the narratives have diverged

Related to the emergence of SARS-CoV2, Dr Tedros also renewed his calls upon China “to share the data and the studies on the origins of this virus. 

“As I have said many times, all hypotheses remain on the table,” he added. He was referring to the still-unresolved debate over whether the virus first emerged as a result of animal transmission to humans in a natural setting or the Wuhan market that housed and slaughtered wild animals – or whether it could have somehow escaped as a result of a biosecurity failure at the Wuhan Institute of Virology, which was studying bat-borne coronaviruses, similar to SARS-CoV2. 

He welcomed, however, the collaboration displayed by WHO member states so far in the initial stages of negotiations of a new pandemic accord, or treaty.

“One of the other key lessons of the pandemic is the need for much stronger cooperation and collaboration rather than the competition and confusion that was the global response to COVID-19. 

“So, I’m very pleased that last week, WHO Member States agreed to develop the first draft of a legally binding accord on pandemic prevention, preparedness and response, based on the principles of equity, solidarity and sovereignty. Member States will begin discussing this “zero draft” of the pandemic accord, in February.”  

WHO member states have generally refrained from describing the potential agreement as a “treaty”, preferring more nuanced terms such as ‘accord’, or even ‘convention’.  However, if the new agreement is indeed binding according to international law, as the current talks suggest, then it will in fact have the force of a “treaty,” added WHO legal counsel Steven Solomon.  

War and hunger overshadow progress on mpox and Ebola, as well as COVID 

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

Tedros also expressed hopes that WHO could pronounce an end to the Mpox global health emergency. A virus belonging to the smallpox family that was largely unknown outside of Africa, it caught the world off guard last spring, when clusters of cases first began appearing in Europe and the United States. 

Since then, “more than 82,000 cases have been reported from 110 countries, although the mortality rate has remained low, with just 65 deaths,” Tedros said. 

But number of weekly reported cases has declined by more than 90% since July, when WHO declared another public health emergency of international concern (PHEIC) for the virus.

“If the current trend continues, we are hopeful that next year we will also be able to declare an end to this emergency,” he predicted.

And meanwhile, a deadly outbreak of the Sudan species of Ebola virus in Uganda, for which no approved vaccine exists, also is fading, with no new cases in more than two weeks. 

“If no new cases are detected, the outbreak will be declared over the 10th of January,” he said. “So we end a difficult year with some encouraging news: COVID-19, mpox and Ebola are all declining.” 

However, against those successes, a series of new threats are looming, he warned. Those include an expanding band of cholera outbreaks, now affecting 29 countries, including violence-wracked Haiti which has more than 14,000 suspected cases, and 1200 confirmed. 

Severe drought in the greater Horn of Africa, is driving an acute crisis of hunger, and with that, surging disease. 

$2 trillion annually invested in ‘killing each other’ 

Tigray refugees on the move over the past year to escape Ethiopan and Eritrean forces which blockaded the region, cutting off aid.

And worldwide, wars and violence in regions across every continent are costing the global economy about $2 trillion annually, pointed out Tedros, who later mentioned that his own uncle had recently been killed during a raid by Ethiopian army on a community in the region of Tigray – despite the recent peace treaty signed between the rebel groups and the government. 

The WHO Director General has spoken out repeatedly about the conflict that led to a months-long Ethiopian blockade of the region, cutting off vital humanitarian and medical aid.

“The question is, does the world have money? The answer is yes. military expenditure is expected to cross $2 trillion a year this year,” he said. 

“Just think of it,$2 trillion US dollars of global expenditure a year to kill people, to kill each other.” he said, adding that during COVID, too, countries came up with tremendous sums to support their economies during lockdown, as well as vaccine development and rollout. 

“So there is money, the issue is commitment,” Tedros said, who admitted that he, himself, was “not in good shape” for the press briefing after hearing about the “murder” of his uncle during a raid by Eritrean forces on a village in the Tigray region. A truce between Ethiopia’s central government and rebels in the Tigray region was declared in November, but Eritrea was not party to the agreement, and its forces have continued to wage war in neighboring areas of Tigray under their sphere of influence or control.   

“We have no problem purchasing 10 years advance, an aircraft carrier, for which we’re paying  $30 to $40 billion, added Ryan. “There’s absolutely no problem whatsoever in making that decision, 10 years in advance, for an operation that’s only part of a foresight exercise. 

“And if those particular platforms of war are not used, … we declare success. We say the world is a safer place. We do not apply the same principle when it comes to protecting and securing the health and welfare of our populations against just as insidious [disease] effects.”

Strengthening finance for pandemic and humanitarian health response

However, recent moves by the UN Secretary General, the World Bank, and the G-20 to create new finance initiatives and mechanisms to fund health offer hope that more money can be mustered for preparedness, as well as  during emergencies, Ryan added. 

“I think we have to look at how to spread the burden of humanitarian response activity across the breadth of member states that we have.” While a small group of rich country donors may be criticized for shifting priorities abruptly or not giving enough “there are many other countries out there that are barely giving anything,” he noted.   

“So the fact that the G-20 has managed to get that process of the G-20 [health and finance] ministers together, with a Secretariat based here in Geneva, and that we will continue the conversation between the people that have money and the people that need to get the money, doesn’t guarantee success.  But the right conversations are happening with the right people. 

Making the health investment case to development banks; talking biosecurity to the military 

“And ín my memory, that’s the first time that’s happened, in a permanent way that’s going to continue. We’re going in the right direction; but we have to get into the development funds, the multilateral funds, the development banks have got to put pandemics and public health and health systems at the center of the investment case for societies. 

“Not just economic development, but health systems development as a central pillar for prosperity, stability, in the future.   

He added that defense departments also can and should be recruited for support – “When we make the case that protecting biosecurity, the ability for us to defend ourselves against pathogens, natural and otherwise, is  mainly mainly delivered through the health system, mainly through the public health system.

“That defense is not delivered due to military intervention. It is delivered through civilian systems. We need to be sure that the resources are there to be able to do that.” 

Image Credits: E Fletcher/Health Policy Watch, WHO Afro, Matt Taylor, @PeterDaszak, WHO/Twitter , © UNFPA/Sufian Abdul-Mouty.

Amid a worldwide surge in cholera outbreaks – a sign of poor access to clean water and sanitation – a key report released on Wednesday shows that only a quarter of countries are on track to achieve their national sanitation targets.

Meanwhile, less than half – a mere 45% – are on track to achieve drinking water coverage targets, according to the World Health Organization (WHO) and UN Water’s Global Analysis and Assessment of Sanitation and Drinking-Water (GLAAS) 2022 report involving data from 121 countries.

Three-quarters of countries also reported insufficient funds to implement their WASH plans and strategies, and few had enough staff to implement plans.

“Almost two million people are dying every year because of poorly managed water sanitation and hygiene,” said Bruce Gordon, head of the WHO’s water, sanitation, hygiene and health unit.

“The plea from WHO is that countries need to recommit to the targets they’ve already made in order to save these lives,” said Gordon.

Bruce Gordon, head of the WHO’s water, sanitation, hygiene and health unit.

Ignoring climate

But what is perhaps the most daunting is how few countries – under half – address the risk of climate change in any of their water, sanitation and hygiene (WASH) plans.

Only 20% of countries reported implementing climate change preparedness approaches for local-level risk assessment and management of WASH at a significant scale.

This is despite billions of people living in areas vulnerable to drought, wildfires, floods, coastal storms and rising sea levels.

“Climate resilience and adaptation to climate change are huge issues that are impacting all of us. And yet when we look at the policy response, whether it’s climate resilient technologies – which are simple things to avoid floods or to mitigate droughts, simple risk management and simple technologies, these are not being put in place,” said Gordon.

Dr Tedros Adhanom Ghebreyesus, WHO Director-General, said: “We are facing an urgent crisis: poor access to safe drinking water, sanitation and hygiene claim millions of lives each year, while the increasing frequency and intensity of climate-related extreme weather events continue to hamper the delivery of safe WASH services.”

Tedros called on governments and development partners to “strengthen WASH systems and dramatically increase investment to extend access to safely managed drinking water and sanitation services to all by 2030, beginning with the most vulnerable”.

Cholera outbreaks

Meanwhile, the WHO reports that 29 countries have reported cholera cases this year, including Haiti, Malawi and Syria which are facing large outbreaks. Cholera is a waterborne disease spread by eating food or drinking water that is contaminated with bacteria.

“In comparison, in the previous five years, fewer than 20 countries on average reported outbreaks. The global trend is moving towards more numerous, more widespread and more severe outbreaks, due to floods, droughts, conflict, population movements and other factors that limit access to clean water and raise the risk of cholera outbreaks,” it noted.

Lebanon, which has been free of cholera for almost 30 years, reported an outbreak in October while Syria is experiencing its first outbreak since 2009.

Meanwhile, Haiti is battling a large outbreak with over 13,000 cases, its first in three years. Over 260 people have died of the disease, and the country received 1.17 million doses of cholera vaccine on Tuesday.

The vaccine (Evichol) was provided by the International Coordinating Group on Vaccine Provision (IGC), which manages the global cholera vaccine stockpile, following a request by Haiti’s Ministry of Public Health and Population. The WHO has recommended that people only get one dose of the two-dose vaccine because of a global shortage.

Off-track for development goals

“The world is seriously off-track to achieve Social Development Goal 6 on water and sanitation for all, by 2030. This leaves billions of people dangerously exposed to infectious diseases, especially in the aftermath of disasters, including climate change-related events,” said Gilbert Houngbo, chair of UN-Water, and Director General of the International Labour Organization. 

“The new data from GLAAS will inform the voluntary commitments the international community will make at the UN 2023 Water Conference in March, helping us target the most vulnerable communities and solve the global water and sanitation crisis.”  

The UN 2023 Water Conference – formally known as the 2023 Conference for the Midterm Comprehensive Review of Implementation of the UN Decade for Action on Water and Sanitation (2018-2028) – will take place at UN Headquarters in New York, 22-24 March 2023.

Image Credits: Unsplash.

South Africans campaign in favour of a tax on sugary drinks in 2017

Taxing sugary drinks can be a win for health and government revenue, according to the World Health Organization (WHO) at the launch of its first ever tax manual for sugar-sweetened beverages (SSB) on Tuesday.

“SSBs have little to no added nutritional value, but their consumption is significantly associated with tooth decay, weight gain and obesity, metabolic conditions and other diet-related non-communicable diseases,” said Dr Rudiger Krech, the WHO’s director of health promotion.

As food prices were a key determinant of food purchases, taxes on unhealthy products had proven to be a deterrent, he added.

Health promotion advocates have been critical of the WHO’s past failure to encourage SSB taxes, but the manual shows that the global body now embraces the strategy. 

“Raising taxes has proven to be the single most potent and most cost-effective strategy for reducing tobacco use, and similarly, we know that right raising taxes on alcohol beverages is also a potent and cost effective strategy for decreasing harmful use,” said Krech.

“This manual provides a practical guide to support an increasing number of policymakers from both health and finance perspectives that are contemplating the use of SSB taxation as the tool to effectively curb their consumption.

In South Africa, the mean daily sugar intake from taxed beverages fell by 37% after the introduction of a tax on sugary drinks in 2018, said Dr Francesco Branca, WHO’s nutrition director.

Last Friday, WHO launched a public consultation on its draft guidelines on fiscal policies to promote healthy diets, which strongly recommend a policy to tax SSBs, added Branca.

“The taxation of sugar-sweetened beverages is amongst the most cost-effective interventions recommended for prevention and control of non-communicable diseases,” he added.

At present, only a fraction of the WHO’s 194 member states tax sugary drinks. Eleven of the European region’s 53 countries do so, along with SSB tax pioneer Mexico, the UK, South Africa, Chile, Barbados and a handful of other countries.

The WHO’s Jeremias Paul, co-ordinator of the tobacco control economics unit, stressed that sugar has little or no nutritional value and the metabolic impact of liquid sugar was much worse than solids containing sugar as well as fibre.

“This manual essentially gives you a blow-by-blow, step-by-step way to build a case for SSB taxation,” said Paul.

“You need to determine the type of tax to impose, what are the taxable products or other or other words, what would be the coverage of products for SSBs? What will be the tax base, whether it’s going to be sugar content or the volume? What are the rates and tax administration capacity?” Paul added.

In Mexico, the government implemented an excise tax on beverages with added sugars, except for 100% fruit juices and beverages with artificial sweeteners. 

“Overall, we found reductions in purchases of taxed beverages and increases in untaxed beverages,” said said Arantxa Colchero from Mexico’s National Institute of Public Health.

“People substituted for bottled water mainly, and we found that the highest rate reductions were among low-income families, high consumers and households with children,” said Colchero.

There was no impact on employment for workers in the sugary drinks sector, either in the industry that produces SSBs nor the shops that sell the drinks, largely because the tax was “very small tax” of 5,3%, the shops sold SSB substitutes and industry also produces bottled water – the main product that consumers moved to, added Colchero.

Encouraging reformulation

UK’s Dr Victoria Targett from the Office of Health Improvement, said that her country’s tax was based on the sugar content per litre, and was  “designed to encourage reformulation” – a voluntary reduction in the sugar content of drinks by producers.

”And we have seen exactly that. In the most recent data that we published on 1 December, we saw that the levels of sugar in drinks that are subject to the levy have come down by 46%,” said Targett.

Dr Mpho Lekote from South Africa’s Treasury said that the introduction of what is termed a “health promotion levy” in his country was championed by Treasury, together with the department of health.

Although they initially proposed a 20% tax on sugary drinks, this was reduced to around 11%, with the first 4g of sugar per 100ml tax-free.

“South Africa has sugar cane growing segments, and there were concerns about the impact of the levy on the sugar cane growers,” said Lekgote, explaining why the tax had almost halved.

Revenue from the tax has dropped as producers have reformulated their drinks, he added.

Image Credits: Heala_SA/Twitter, Kerry Cullinan.

Dr Jeremy Farrar, director of Wellcome Trust

Wellcome Trust director Dr Jeremy Farrar will become the World Health Organization’s (WHO) Chief Scientist in the second quarter of 2023, according to announcements by the WHO and Wellcome on Tuesday.

Farrar’s second five-year term is ending next February and Wellcome Trust “have been planning the transition for some time, and a global search for a permanent CEO began earlier this year”, according to Julia Gillard, chair of the trust’s board.

“Jeremy’s leadership and insight have seen Wellcome achieve remarkable growth, realising ambitions in science and health on a scale not previously possible,” added Gillard.

 

“His vision has enabled Wellcome’s bold £16 billion strategy for the next decade, supporting scientific discovery and solutions to tackle the greatest health threats facing us all – mental health, escalating infectious disease and the health impacts of the climate crisis.”

During the Covid-19 pandemic, Farrar led Wellcome’s advocacy for rapid investment in research on testing, treatments and vaccines. He was a participant of the UK Scientific Advisory Group for Emergencies (SAGE) from the start of the pandemic until his resignation in October 2021, and a member of the Principals Group of the WHO’s ACT-Accelerator. 

Global expertise

Gillard added that Wellcome was “delighted that the global health and science community will continue to benefit from his expertise and wisdom in his new role at the World Health Organization”.

Farrar, a clinician scientist, takes over from Dr Soumya Swaminathan in overseeing the WHO’s science division. Before joining Wellcome in 2013, he spent 17 years as director of the clinical research unit at the Hospital for Tropical Diseases in Viet Nam.

 

Farrar is a Fellow of the Academy of Medical Sciences UK, European Molecular Biology Organisation (EMBO), the National Academies USA and a Fellow of The Royal Society.

“We are living through fragile and uncertain times, with huge inequities to address,” said Farrar in a media statement.

However, he added that there had also been “breath-taking and life-changing advances in science and health” during the decade that he had been at Wellcome.

New Chief Nurse

Meanwhile, Dr Amelia Latu Afuhaamango Tuipulotu will become WHO’s Chief Nursing Officer at the start of 2023. In 2019, she became the first female Minister for Health of the Kingdom of Tonga, and before that was Tonga’s Chief Nursing Officer.

 

Previously, director of nursing at Vaiola Hospital, she was the first Tongan to receive a PhD  in Nursing. In 2019, she was appointed Honorary Adjunct Associate Professor at the University of Sydney. From May 2020 to December 2022, Tuipulotu was a member of the WHO Executive Board.

As WHO’s Chief Nursing Officer, Tuipulotu will “champion, nurture and support nurses and midwives to ensure that their skills and experience are being well-utilized to strengthen health systems and to bolster their critical role in bringing patients, communities and national health systems closer together”, according to the WHO.

“I am delighted that Jeremy and Amelia will join WHO at a critical time in global public health when investment in both the health workforce and science is imperative to strengthening health systems and outbreak preparedness and prevention,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

“As Chief Scientist, Jeremy will accelerate our efforts to ensure WHO, its Member States and our partners benefit from cutting-edge, life-saving science and innovations. As Chief Nursing officer, Amelia will ignite the all-important need not only to fill the gap in health workers worldwide but also to ensure they receive the support they need and deserve.”

Paul Schreier, Wellcome’s Chief Operating Officer, has been appointed interim CEO from 25 February 2023. 

Image Credits: Megha Kaveri/Health Policy Watch .

Testing a patient for hypertension. Two-thirds of Africans with high blood pressure are unaware of this.

Africa’s limited pharmaceutical industry, high costs of raw materials, and dependence on imported medicines have long hampered citizens’ access to the medicines they need. 

The challenges the continent faces are daunting. They include poor supply chain systems, lack of government investment in the pharmaceutical sector, unfavourable manufacturing conditions, limited health workforce, lack of sustainable health financing mechanisms or infrastructure and technical know-how, low investment in research and development, and circulation of fake medicines. 

Rectifying these problems is where the African Medicines Regulatory Harmonization (AMRH) programme comes in. Five years after the inaugural AMRH Week in Kigali, Rwanda in 2018, experts gathered in Ghana last week to discuss the AMRH’s potential to address these gaps, drive change for the African continent, achieve Universal Health Coverage, and galvanize resources to meet the continent’s health needs.

The week brought together African leaders and policymakers, members of the AMRH steering committee and technical committees,  regional economic communities, the AMRH Partnership Platform and other partners and stakeholders.

Safe medicine

“At its core, the mission of the AMRH is to facilitate the harmonization of medicine regulation and to create the desired outcome of access to quality, safe, efficacious and affordable medicine for the African continent,” said Mimi Darko, CEO of Ghana’s Food and Drugs Authority. “There are many reasons this is critical but in recent times nothing has brought this home but the ravages of the COVID-19 pandemic.”

COVID-19, she said, helped to shift the attention of many African countries from the short-term, urgent needs of their populations to building long-term resilience for the continent.

“It is no surprise that vaccine production is at the centre of initiatives culminating in the partnership for the African Vaccine Manufacturing, the first ever kind of collaboration for Africa,” added Darko.

This year’s focus was on regulatory processes, harmonization and strengthening National Regulatory Authorities (NRAs) across Africa and other low- and middle-income countries facing challenges in ensuring access to quality-assured medical devices, in-vitro diagnostics, personal protective equipment (PPEs) and other health products.

European Medicines Agency offers support

Dr Matshidiso Moeti, WHO Regional Director for Africa.

Emer Cooke, executive director of the European Medicines Agency (EMA), said it was critical for Africa to develop its medicines agency to gain control over regulatory and price mechanisms for the continent.

“The EMA’s support for the region during the pandemic was enormous through the EU-AU partnerships and the Africa CDC. But what is critical now is the efforts to establish the African medicine agency initiative,” Cooke said. “This will help coordinate, facilitate and harmonize access to medicine for disease cohorts in the region.”

The EMA pledged to give the AMRH steering committee technical support to address some of the challenges highlighted.

Slow pace of ratifying AMA

Dr David Mukanga, deputy director of African regulatory systems at the Gates Foundation and chairperson of the AMRH Partnership Platform, said member states’ delays in ratifying the AMA treaty was the main challenge so far.

“The rate at which we’re moving as a continent in signing and ratifying the AMA treaty is of great concern. This is because ensuring that medicine and medical products are available for everyone is a huge task and we need to move faster in professing solutions by turning our ideas into products for our people and the delays are not helping” he stressed.

In the long term, Mukanga said leveraging the scarce resources of the continent to create the AMA would help to  will deliver universal health coverage.

Dr Matshidiso Moeti, the World Health Organizations’ (WHO) Africa regional director, said in a statement to the meeting that substantive strides have been made by the AMRH to develop the regulatory framework to oversee pharmaceutical products, capacity building and technical support for member countries.

The AMRH strategy, which is operating in five regional and economic committees, has been able to deliver positive results by helping countries to access a robust legal framework and to harmonize regulatory requirements, standards, processes and capacity building.  

However, she urged the extension of regulation from generic medicine to cover new chemical-entity vaccines, medical devices and in-vitro diagnosis, hinting that $1 million has been allocated for the AU-WHO joint work plan to  establish and operationalise the AMA.

Pledging the WHO’s support for the AMA, she called for local investments in the regulatory systems and its processes to safeguard it.

Image Credits: Hush Naidoo Jade Photography/ Unsplash.

COVID-19, conflicts and climate change are posing additional challenges to efforts to achieve universal health coverage (UHC) in the Eastern Mediterranean region (EMRO), the World Health Organization (WHO) acknowledged on the eve of Universal Health Coverage (UHC) Day on Monday.

“The COVID-19 pandemic demonstrated the vulnerability of our health, social protection and economic systems,”  Dr Ahmed Al-Mandhari, WHO EMRO regional director told a media briefing on Sunday at the start of a three-day regional UHC meeting.

“Half of all countries in our region are experiencing protracted conflicts and humanitarian crises. Eight of them have reported outbreaks of cholera and acute watery diarrhoea. Extreme climate events, like the floods in Pakistan and drought in the Horn of Africa, are leading to acute hunger and health crisis.”

Dr Ahmed Al-Mandhari, WHO EMRO regional director

Cholera outbreaks signal weak systems

Lebanon had been cholera-free for the past 30 years until a few months back when it reported an outbreak, indicative of challenges to its water supply amid the country’s weakening economic crisis, according to Dr Rana Hajjeh, WHO EMRO director of programme management.

“Cholera is not only a repercussion of climate change,” said Hajjeh. “It is evidence of weak and fragile health systems. We have two countries in the eastern Mediterranean region suffering from cholera at the moment in addition to the six countries where it is endemic. 

“Cholera in Syria and Lebanon is a very grave sign as it is linked to the collapse of the infrastructure, not only the health of infrastructure but also all that is relevant for the cleanliness of water and securing of clean water and services for citizens.”

However, climate change was having a huge impact on the region, Hajjeh acknowledged. The floods in Pakistan, one of the biggest EMRO member states, had disrupted the country’s health systems, while Somalia was in the midst of a very severe drought, and was in a grave food crisis in Somalia “and may be encountering starvation”.

The WHO had developed guidelines for member states on climate change and would assist them to address its impact.

Dr Suraya Dalil (left) and Dr Rana Hajjeh, WHO EMRO director of programme management.

Primary Health Care

“Primary health care is the most cost-effective way to bring services or health and wellbeing closer to individuals and communities. Reorienting our health systems towards the primary health care approach means engaging in multisectoral action, ensuring community engagement, increasing equitable access to quality health services and strengthening public health functions, added Al-Mandhari.

UHC Day is an official United Nations designated day that marks the anniversary of a unanimous decision seven years ago to endorse UHC as an essential component of international development, and work towards achieving this globally by 2030.

“UHC means that all individuals and communities receive the health services they need without suffering financial hardship. It includes the full spectrum of essential quality health services across the life course from health promotion to prevention, treatment, rehabilitation and palliative care,” added Al-Mandhari.

Meanwhile, the WHO plans to mark UHC Day with an event at the FIFA Fan Festival in Doha, Qatar, on the eve of the World Cup semi-finals on Tuesday. 

The WHO also issued its UHC service Package Delivery and Implementation Tool aimed at supporting countries to design and implement comprehensive health service packages to meet the needs of their populations on Monday.

It also launched a digital knowledge hub for the public called, ‘Your life, your health: Tips and information for health and wellbeing,’ to provide people with trustworthy health information.

Image Credits: UN-Water/Twitter .