A healthcare worker gives a child a dose of the world’s first malaria vaccine, RTS,S. A second malaria vaccine has now been approved.

IBADAN, Nigeria – There are high hopes that the R21/Matrix-M malaria vaccine recently approved by Ghana and Nigeria will be manufactured in Africa in the not-to-distant future – a brighter-than-usual prospect for this World Malaria Day (25 April).

Earlier this month, Ghana’s Food and Drugs Authority (FDA) approved the R21/Matrix-M malaria vaccine manufactured by the Serum Institute of India (SII) for use in children aged from five months to three years, the age group at the highest risk of death from malaria. 

This was despite the vaccine not yet being given World Health Organization (WHO) prequalification approval. 

SII, the manufacturing and commercialisation license holder for the vaccine, described Ghana’s approval as the “first crucial step [that] will enable the vaccine to help Ghanaian and African children to effectively combat malaria”.

“The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives,” said Adar Poonawalla, SII CEO.

Shortly afterwards, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) also granted a “registration approval” for the vaccine to SII. The agency said it had received the dossier of the vaccine and it had been subjected to independent review at two levels. 

The agency added that the vaccine’s dossier substantially complied with best international standards, and that its Joint Review Committee had concluded the vaccine data was robust and met the criteria for efficacy, safety, and quality. 

Local production?

Ghana’s regulator announced that the application for regulatory approval had been submitted by SII’s ‘local agent’, DEK, which expects to eventually manufacture the vaccine locally.

“The status of the [Ghana] FDA Lab creates a great advantage for the local agent who hopefully will be manufacturing the malaria vaccine in Ghana in the near future,” the agency stated.

A few days after the regulatory approval, a ground-breaking ceremony of the DEK Vaccines Limited’s vaccine fill-and-finish plant was held. The company is a private sector-led consortium of Ghanaian pharmaceutical companies.

At the ceremony, Ghanaian President Nana Addo Dankwa Akufo-Addo, said it “will help our nation realise the dream of becoming self-sufficient in the manufacture of vaccines”.

Meanwhile, Nigeria’s regulator announced Fidson Healthcare Ltd, a major local bourse-listed player in the country’s pharmaceutical industry, as the vaccine’s Marketing Authorization Holder (MAH). This authorizes the Nigerian firm licensed to distribute, sell and commercialize the vaccine in Nigeria.

The Nigerian government also revealed in September 2022 that it had signed a local vaccine manufacturing agreement involving Biovaccines Nigeria Limited (a joint venture between the Federal Government of Nigeria and May & Baker Nigeria Plc), and SII.

“The government has approved 15% of the vaccines that UNICEF normally supplies to Biovaccines to supply through contract manufacturing with the Serum Institute of India. With that, the institute will now be comfortable enough to come and join Biovaccines Nigeria in building its manufacturing plant here in Nigeria in Ota,” Nigerian health minister, Osagie Ehanire said.

From Oxford to West Africa via India

An infant receiving the RTS,S malaria vaccine in Ghana in 2019. 

Designed and developed at the University of Oxford, the vaccine has been tested in the United Kingdom, Thailand, and several African countries. 

A Phase Three trial that is underway in Burkina Faso, Kenya, Mali and Tanzania has enrolled 4,800 children and the results are expected later this year. 

While the regulator in Nigeria has also recommended an in-country Phase Four clinical trial or pharmacovigilance study in the implementation, given the peculiarity and heterogeneous nature of malaria in Nigeria, it noted that the efficacy results from the vaccine’s clinical trials contributed to its decision to approve it.

Last year, the Oxford researchers and their partners reported from a Phase 2B trial that a booster dose of R21/Matrix-M at one year, following a primary three-dose regime, maintained high efficacy against malaria, and continued to meet the WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. 

This followed 2021 results from the Phase 2B trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77%. Recent data from the large phase III trial also show high levels of efficacy and a reassuring safety profile. 

Prof Adrian Hill, chief investigator for R21/Matrix-M programme, and Director of the Jenner Institute at the University of Oxford, described the regulatory approval of the vaccine as the culmination of 30 years of malaria vaccine research at Oxford. 

“I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children,” Hill said. 

The vaccine contains Novavax’s Matrix-M which is a saponin-based adjuvant that enhances the immune system response, making it more potent and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This technology has also been used successfully in Novavax’s COVID-19 vaccine and is a key component of other development-stage vaccines.

An approval without a WHO prequalification

Unlike the developments surrounding the approval of the COVID-19 vaccines in the African countries that largely followed a prequalification approval by the WHO, both Ghana and Nigerian regulators went ahead to approve the vaccine without any WHO approval. 

In addition to affirming their regulators’ competence and authorization to undertake such approvals, Dr Franklin Asiedu–Bekoe, Director of Public Health in Ghana, told Health Policy Watch that the vaccine – the second malaria vaccine that the country is rolling out – will be closely reviewed by the country’s team of scientists.

“In Ghana, we have 93 districts that are now using the TRS,S. There are a number of districts that are yet to be using it. So if we have a vaccine, which is good, I think nothing stops us from using it,” he argued.

Moreover, Prof William K. Ampofo, Secretary of the Presidential Committee on Vaccine Manufacturing and Development, Ghana, added that the approval was in response to the manufacturer’s application.

“The vaccine was approved based on the application by the manufacturer Serum Institute. It was not an independent decision by the Ghana FDA. It was in response to the application by the Serum Institute for the R21 vaccine based on the data that had been accumulated,” Ampofo told Health Policy Watch.

Local manufacturing elements of both approvals

In the weeks before regulatory approval for the R21 vaccine, Ghana officially expanded access to the WHO-approved RTS,S malaria vaccine. Four years on, more than 4.5 million doses of the vaccine have been administered through the countries’ routine immunization programmes. 

“Community demand for the vaccine is high and the vaccine is well accepted in African communities, even when additional visits to vaccination clinics are required to receive the four-dose schedule,” WHO revealed. 

But RTS,S rollout has been plagued with concerns regarding its comparatively minimal efficacy, high cost and limited supply. 

In sharp contrast, R21’s demonstrably higher efficacy (more than 75% over 12 months) and comparatively lower cost ($3 compared with RTS,S’ $5 per dose) made it even more attractive to African countries – along with the manufacturer’s announcement of potential manufacturing capacities of more than 200 million doses annually.  

But beyond these essential factors are also considerations for local manufacturing from the outset of the vaccine’s introduction in Africa.

WHO and Gavi falling in line

Even though the WHO prequalification certification has not yet approved the R21 vaccine, the WHO has expressed its support for the vaccine, acknowledging on its website that a second malaria vaccine may be coming forward.

“The WHO prequalification process is also underway. WHO will continue the thorough and efficient review of the R21 vaccine and awaits the submission of additional analyses by the vaccine developer,” the global health body said.

Dr Phionah Atuhebwe, New Vaccines Introduction Officer at WHO AFRO Regional Office, added that the WHO is already evaluating the vaccine’s safety, efficacy, quality and programmatic suitability.

“Ghana and Nigeria have not jumped the gun because it is expected that, at national level within their jurisdiction, the national regulatory authorities can also review data once they have received information from different vaccine developers,” she said.

Gavi’s Aurelia Nguyen

Aurelia Nguyen, Chief Programme and Strategy Officer for Gavi, the Vaccine Alliance, also told Health Policy Watch that the alliance is prepared to provide funding for the R21 malaria vaccine. 

“It is a hugely exciting development with the approvals that we’ve seen in Ghana and Nigeria. This is all moving us forward towards having a second vaccine,” Nguyen said. 

She noted that the restricted supply of the RTS,S made it “really important” to have several tools, in addition to affordability.

“It’s not just about the volumes, it’s also about the affordability. Serum Institute has made a very important public commitment in terms of keeping the cost of the vaccines to $3 or less. So we really look forward to them honoring that commitment because ultimately, it will mean that more people are protected,” Nguyen concluded.

Image Credits: WHO/Fanjan Combrink, WHO/M. Nieuwenhof, WHO.

“No child should die of a vaccine-preventable disease,” said WHO Director-General Tedros Adhanom Ghebreyesus.

The world’s largest global health organizations have announced a partnership to reverse the years-long backslide in global childhood vaccination rates caused by the COVID-19 pandemic. 

An estimated 67 million children missed at least one essential vaccination between 2019 and 2021 and 50 million of these didn’t receive any vaccines – setting back childhood vaccination rates to their lowest level since 2008. 

But the “Big Catch-Up”, billed as an “extended effort” to restore vaccination levels in children to at least pre-pandemic levels and shore up essential health services for immunization programmes, does not contain any new financial commitments. 

Participants include the World Health Organization (WHO), UNICEF, the vaccine alliance Gavi, the Bill & Melinda Gates Foundation and a number of national and global health organizations. 

In the past three years, the overburdening and disruption of health services by COVID-19 containment efforts eroded over a decade of gains in routine childhood immunization levels. 

The vaccination schedules of millions of children around the world were knocked-off course, exposing them to life-threatening viruses that can be prevented by existing vaccines.

Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters the “Big Catch-Up” partnership does not involve any new financial commitments to bolster global childhood vaccination efforts.

Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters on Monday that preliminary estimates indicate that the backslide in childhood vaccinations has led to “at least” a five percent increase in mortality among children. 

“Every one of these lives that are lost is on top of the mortality that already exists because of the imperfection of the coverage and immunization programmes,” O’Brien said. “There will continue to be these children who are at risk going forward unless they are caught up.”

Over 100 countries recorded declines in childhood vaccination rates during the pandemic, but three-quarters of the 25 million children who missed vaccinations in 2021 live in just 20 low- and middle-income countries. These will be a “particular focus” for the global coalition. 

“Millions of children and adolescents, particularly in lower-income countries, have missed out on life-saving vaccinations, while outbreaks of these deadly [preventable] diseases have risen,” said WHO director-general Tedros Adhanom Ghebreyesus. “Catching up is a top priority. No child should die of a vaccine-preventable disease.”

Inequality is still behind vaccine access 

When UNICEF first began tracking childhood vaccination rates in 1980, just one in 10 children in the world’s poorest countries would “ever see a trained health worker or be immunized” before their first birthday. By the start of the next decade, seven in 10 children around the world were protected by vaccines – rising steadily to a height of 86% in 2019. 

Despite decades of progress, the story of children not receiving essential childhood vaccines remains one of inequality and poverty. 

One in five children in the world’s poorest households today are ‘zero-dose’, meaning they have never received a vaccine of any kind, according to UNICEF’s 2023 State of the World’s Children report released last week. In West and Central Africa, that number rises to nearly one in two, compared to one in 20 in the wealthiest countries. 

“Routine vaccines are typically a child’s first entry into their health system and so children who miss out on their early vaccines are at added risk of being cut out of healthcare in the long run,” UNICEF executive director Catherine Russel said. “The longer we wait to reach and vaccinate these children, the more vulnerable they become and the greater the risk of more deadly disease outbreaks.”

Asked about the role of vaccine scepticism in dropping child vaccination rates, O’Brien stressed that while the global proliferation of misinformation around vaccines is “deeply concerning” – UNICEF found vaccine confidence dropped in 52 out of 55 countries – it remains a minor factor compared to income. 

“The main reason that kids are unvaccinated is not anti-vax [beliefs],” O’Brien said. “The main reason why children are unvaccinated has to do with access to services, quality of services, and the full availability of programmes.”

Big ambitions, no extra funding 

No new funding to support the goal of returning childhood vaccination rates to pre-pandemic levels is included as part of the “Big Catch-Up”. 

“We’ve done an assessment of the resources that are out there, and we do feel that the resources are there,” O’Brien. “There are substantial resources already in-country and still available to countries through many different mechanisms.”

Meanwhile, Medecins sans Frontieres (MSF) highlighted that children in conflict zones were particularly affected.

“Despite the progress made in expanding global vaccination coverage, nearly 11 million of the un- and under-vaccinated infants live in fragile or humanitarian settings, including countries affected by conflict, and remain the most vulnerable to disease outbreaks,” said Dr Sharmila Shetty, Vaccines Medical Advisor for MSF’s Access Campaign.

Africa’s burden

According to estimates by WHO and UNICEF, the number of zero-dose and under-immunized African children rose by 16% between 2019 and 2021 to a cumulative total of about 33 million, nearly half the global figure.

At a WHO AFRO press briefing last Thursday, Gavi, The Vaccine Alliance, revealed it is working in Sierra Leone and Ghana to ensure that the millions of children and adolescent girls who missed out on vaccines during the pandemic are protected.

“We’re very, very happy to be marking in a few days, the 2023 edition of the Africa Vaccination Week, and it’s a really good opportunity for us to take stock and to remind ourselves of what we have achieved but also what we are dealing with in terms of recovering from a pretty unprecedented emergency during the pandemic,” said Aurelia Nguyen, Gavi’s Chief Programme and Strategy Officer.

Nguyen said that Gavi is working closely with its partners to support countries in making up lost ground and building stronger, more resilient systems. The efforts will focus on on hard-to-reach communities and implementing national programmes that are able to reach children and communities more effectively.

Gavi is also focusing on the human papillomavirus (HPV) vaccine program, which was one of the hardest hit during the pandemic. With cervical cancer being the most common cause of cancer death in nearly half of sub-Saharan African countries, Nguyen noted that the HPV vaccine can prevent up to 90% of cervical cancer cases. 

So far, Gavi said it has supported 20 African countries to produce the HPV vaccine and received $600 million in extra investment last year to revitalize the program and strengthen health systems.

“As we think about many, many challenges ahead, we also are considering the opportunities and we have a young and growing population, and so it’s really our responsibility and opportunity to make sure that we don’t leave any child behind with immunization,” said Nguyen.

  • Additional reporting by Paul Adepoju.

Image Credits: WHO / Billy Miaron.

The working group on amending the IHR met in Geneva last week (20-24 Februar 2023).

Negotiations to tighten up the World Health Organization’s (WHO) International Health Regulations (IHR) to make them pandemic-ready made “excellent progress” – but it still faces enormous obstacles.

WHO member states spent four days last week addressing 100 of the 300 proposed amendments to the IHR, dealing particularly with compliance, implementation, and public health response. 

In describing the “excellent progress”, co-chair of the Working Group of the IHR (WGIHR), New Zealand’s Dr Ashley Bloomfield, said that discussions also “considered critical areas such as core capacities for surveillance and response, collaboration and assistance”. 

In addition, six newly proposed articles and one new annex were put on the table.

Fellow Co-Chair, Saudi Arabia’s Dr Abdullah Assiri described the tone of the meeting as positive and constructive.

“Countries are in the driving seat of this process as they need to implement the IHR, deliver on the obligations, and make the key decisions needed to respond to public health threats,” said Assiri.

Pandemic weaknesses

The IHR were originally adopted to set out agreed approaches and obligations for countries to prepare for, and respond to, disease outbreaks and other acute public health events with risk of international spread. 

However, they proved inadequate during the COVID-19 pandemic, as pointed out by WHO Director-General Dr Tedros Adhanom Ghebreyesus.

“During the COVID-19 pandemic, the international community has learned a great deal about how the IHR functions in a public health emergency of international concern. But the pandemic also revealed deep inequalities in the global health architecture at the national and global levels,” said Tedros.

“It’s important to note that currently, the IHR are the only universal instrument for global health security that the world has,” added Tedros.“That’s why bold but well-targeted amendments are so vital.” 

“The IHR rely on the worldwide application of obligations for international cooperation and assistance in respect of human rights and the underlying principles of solidarity,” said Tedros.

“The process of amending the IHR offers an opportunity to strengthen and extend these principles, but these adjustments to the IHR also have practical implications, as we have learned from many outbreaks in recent years, especially during the early stages of a potential public health emergency.”

Incentives for pathogen sharing

Tedros said that the IHR’s incentive structures are not well-aligned, as some states that quickly notified WHO were “sometimes penalised by travel and trade restrictions”. He added they should be amended to encourage rather than punish transparency and IHR compliance.

Huge challenges remain to be resolved, however, particularly around pathogen sharing. The Africa group wants the WHO to establish a repository for cell lines to accelerate the production and regulation of generic products and vaccines.

Meanwhile, Bangladesh also wants the WHO to set up a database of the ‘recipes’ of vaccines and medicines needed during public health emergencies of international concern, as well as know-how related to their manufacturing.

Image Credits: WHO.

WHO Director General Dr Tedros Adhanom Ghebreyesus describes WHO’s policy reforms in prevention of sexual exploitation, abuse and harassment in a January 2023 meeting with the WHO Executive Board0, following a string of cases in Geneva and elsewhere.

The World Health Organization (WHO) has dismissed a senior manager at its Geneva Headquarters, Temo Waqanivalu, on charges of sexual misconduct following a six-month investigation into allegations that he harassed a young British doctor at the World Health Summit in Berlin last October. 

This is the first high-profile dismissal of an official at WHO’s headquarters following a string of recent complaints and investigations involving personnel in Geneva, in WHO regional offices, and the WHO’s Ebola response team that operated in the Democratic Republic of Congo (DRC) from 20180-2020.     

“Temo Waqanivalu has been dismissed from WHO following findings of sexual misconduct against him and corresponding disciplinary process,” WHO spokesperson Marcia Poole told Health Policy Watch in response to a query on Monday. 

The WHO response came exactly six months and one week after Dr Rosie James first tweeted that she had been “sexually assaulted” by a WHO staff member while attending an evening reception at the World Health Summit in Berlin, which WHO co-sponsored. 

At the time, WHO Director-General Dr Tedros Adhanom Ghebreyesus responded by saying that he was “sorry and horrified” and urged her to file a complaint. 

James expresses relief following close of six-month investigation 

Dr Rosie James

In the end, the investigation took six months to complete. But that, WHO officials have stressed that six months is in fact the time frame set by the organization to ensure due process for both the complainant and the accused in such cases.   

Speaking to Health Policy Watch, James said that it “feels good that it is (hopefully) over.”

She said that she had received news from WHO of the dismissal in a letter on Monday.  But in the letter, the organisation also warned her against talking about the investigation saying “…. In this regard you are kindly reminded of the undertaking of confidentiality that you signed.” 

“I’m scared to say anything,” she told Health Policy Watch. “But it’s a relief to know that hopefully, I was the last woman to be affected by him.

“I hope that this gives confidence to other women to report cases, knowing that this case was taken seriously,” she added.  

She said that the process had been more emotionally stressful than she had anticipated – adding that access to some kind of counselling framework would have been helpful. 

“Having some support offered would have been nice, like a list of contact services that I could have available,” she added. “I think they did send me the email of one doctor or something, but I just felt like it was a really isolating process because I wasn’t allowed to talk with anyone.”

“Speaking up is [although not easy!] and option, she added in a Tweet.

Waqanivalu can still appeal the dismissal    

Temo Waqanivalu with his former team in WHO’s Department of Noncommunicable Diseases (NCDs).

Speaking on behalf of WHO, spokesperson Marcia Poole said that “any administrative decision including dismissal from service may be appealed through the [WHO] internal justice system, and ultimately by filing a complaint before the International Labour Organization Administrative Tribunal.”

But meanwhile, she added that “WHO participates in the UN ‘ClearCheck’ screening database and perpetrators of sexual misconduct are entered into the database as a matter of standard process to avoid their hiring or re-hiring by UN agencies.

“Sexual misconduct of any kind by anyone working for WHO – be it as staff, consultant, partner – is unacceptable,” added Poole.

With regards to Jame’s remarks on her experience of the process, Poole told Health Policy Watch, “Over the past year-and-a-half, WHO has been implementing a comprehensive programme of reform across the entire organisation to prevent sexual misconduct and ensure that there is no impunity if it does and no tolerance for inaction. 

“We encourage all those who may have been affected by sexual misconduct to come forward through our confidential reporting mechanisms. All cases will be reviewed promptly.”

“We are listening to survivors and applying lessons learnt throughout the process so that we can realise our ambition to become ‘best in class’ when it comes to preventing and responding to SEA [sexual exploitation and abuse].”

Former frontrunner for Western Regional Office position 

Dr Temo K Waqanivalu
Dr Temo K Waqanivalu, a senior WHO staffer accused of sexual misconduct, is also campaigning to become Director of WHO’s Western Pacific Regional Office.

Prior to the incident in Berlin in October 2022, Waqanivalu was considered to be a front-runner in the race to become WHO’s next director of the Western Pacific Region. The former regional director, Takeshi Kasai, was recently dismissed from the post as a result of unrelated charges of harassment and racism.    

After being named publicly as the alleged perpetrator of the incident in Berlin as well as harassing a woman at a WHO workshop in 2017 in Japan, those hopes faded. 

According to media reports that surfaced in January, Waqanivalu had allegedly pursued and groped a woman at the Japan workshop who complained to a WHO ombudsperson. But the woman reportedly was discouraged from pursuing a formal complaint at that time.  

Waqanivalu, who has been on leave for the past six months, previously led WHO’s work on the integrated delivery of non-communicable disease services (NCDs).

In the case of James’s complaint, her decision to go public with the allegation of misconduct put a spotlight on the case from the beginning – even though she did not name the perpetrator at the time. 

There also were witnesses to the incident that occurred at the World Health Summit, a public WHO event. That places the case squarely within the scope of a  new WHO policy, which applies to a broad range of people interacting with WHO and in “locations where WHO staff and/or collaborators operate.” 

Image Credits: Twitter/@rosiejames96, Twitter/@@waqanivalut, WHO campaign brochure.

Air pollution
Air pollution is the 10th leading cause of death in the European Union.

Air pollution causes over 1,200 premature deaths per year in people under the age of 18 in the Europe and significantly increases the risk of disease later in life, according to European Environment Agency (EEA) air quality assessment published on Monday. 

“Despite improvements over past years, the level of key air pollutants in many European countries remain stubbornly above World Health Organization (WHO) health-based guidelines, especially in central-eastern Europe and Italy,” according to the EEA. The agency’s report covers the 27 members of the European Union as well as some non-EU EEA members such as Switzerland, Norway, and Liechtenstein.

Some 97% of the urban population is exposed to annual concentrations of fine particulate matter (PM2.5) above the 2021 WHO annual guideline of 5 micrograms per cubic meter (µg/m3), the report stated.

Traffic, heating, and industry are the main sources of air pollution in Europe, and while emissions have declined, air pollution levels are still not safe – particularly for children.

Sector contributions to primary emissions of major hazardous air pollutants in the EU (2020).

Low birth weight, asthma, allergies and reduced lung function

Children are more vulnerable to air pollution than adults as they have higher and faster breathing rates, taking in more air per kilogram of body weight and breathe air closer to the ground where some pollutants, especially from vehicle exhaust, are emitted and become concentrated. 

“Moreover, children inhale a larger fraction of air through their mouths than adults. Due to this increased oral breathing, pollution penetrates deep into the lower respiratory tract, which is more permeable,” according to the EEA.

Their bodies and organs, including their lungs, are also still in development, which further increases risk and their immune systems are weaker than those of adults.

Children are more vulnerable to air pollution than adults (European Environmental Agency).

“Maternal exposure to air pollution during pregnancy is linked to low birth weight and risk of pre-term birth,” according to the agency.

“After birth, ambient air pollution increases the risk of several health problems, including asthma, reduced lung function, respiratory infections and allergies. It also can aggravate chronic conditions like asthma, which afflicts 9% of children and adolescents in Europe, as well as increasing the risk of some chronic diseases later in adulthood.”

There is also growing evidence that air pollution affects children’s brain development, contributes to cognitive impairment, and that it may play a role in the development of some types of autism.

The agency recommends that particular attention should be paid to improving air quality near schools and kindergartens, such as growing vegetation to screen pollution.

“Air pollution levels across Europe are still unsafe and European air quality policies should aim to protect all citizens, but especially our children, who are most vulnerable to the health impacts of air pollution,” said EEA Executive Director Hans Bruyninckx.

“It is urgent that we continue to step up measures at EU, national and local level to protect our children, who cannot protect themselves. The surest way to keep them safe is by making the air we all breathe cleaner.”

Image Credits: Mariordo, European Environment Agency (EEA).

Sudan
A three-day ceasefire called for by the United Nations, United States and others has failed to stop the fighting.

As the new moon marking the beginning of Eid festivities rose on Thursday evening, people in the Sudanese capital of Khartoum sheltered from bullets and explosions as prayers that a ceasefire to honour the end of the holy month of Ramandan would take effect went unanswered. 

At least 400 people have been killed in a clash between two powerful military leaders in Africa’s third-largest country that broke out a week ago. The fighting has forced 70% of the hospitals in the conflict zones to shut down, leaving thousands of injured civilians with nowhere to go. Nine hospitals have been bombed and 16 were forcibly evacuated by military forces, the Central Committee of Sudanese Doctors (CCSD) reported. 

Hospitals that remain operational are overwhelmed, understaffed, and under-supplied. Critical supplies of oxygen, blood and life-saving medicines are running out, and the few medical workers that remain are struggling to access hospitals and medical centres due to the intensity of the fighting. 

“The lack of safe access to electricity, food, water, personnel, and the diminishing medical supplies are making it nearly impossible for many health facilities to function at the exact time when there are thousands injured and in need of urgent care,” World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus said.

Health workers have also been caught in the crossfire. At least three health workers have been killed as well as three World Food Programme staff. A doctor working in one of the remaining hospitals in Khartoum told the BBC he and his colleagues are “expecting … to get shot”. 

“Humanitarian operations in Sudan are virtually impossible at this moment,” United Nations Secretary-General Antonio Guterres said. “Targeting humanitarian workers and humanitarian assets must end.”

The WHO said it has received reports of sexual assaults on humanitarian workers, attacks on doctors, military occupations and looting of hospitals, and ambulance hijackings. 

“The situation is catastrophic. We are still hearing gunfire from our compound as I speak. It is very unsafe because of the shooting and the shelling,” Médecins Sans Frontières (MSF) Sudan project coordinator Cyrus Paye said from an MSF-supported hospital in the western city of El Fasher. “The majority of the wounded are civilians who were hit by stray bullets, and many of them are children.”

On Thursday, military forces looted the paediatric hospital that Paye and his colleagues relied on to provide care to babies with sepsis or born prematurely. All the other hospitals in the city have been forced to close.

“Health facilities are running out of supplies and staff cannot get to work. Health workers, relief workers and rescue workers have all become immobilized by the fighting and people are dying as a result,” Paye said. “Access [to supplies] is what will change this. That, and a guarantee from the warring parties that they will spare civilians’ lives.”

The situation in the capital is just as dire. 

“Hospitals are running out of not just food, but medicine too. The internet cuts in and out. Electricity comes and goes,” said Germain Mwehu, a spokesperson for the International Committee of the Red Cross (ICRC) based in Khartoum. “It’s a matter of life and death that we deliver help. This is what people need most urgently.”

Airport closures have so far stymied efforts by the WHO and others to airlift emergency medical supplies to Sudan to alleviate the shortages. Dr Ahmed Al Mandhari, WHO’s regional director for the Eastern Mediterranean, said the UN health agency’s emergency response teams are on standby. 

“As soon as travel restrictions to Sudan are lifted, additional WHO specialist staff for trauma care, public health, logistics and security are available. Further supplies are on standby to be airlifted from our logistics hub in Dubai,” Al Mandhari said. “We are really hopeful that … the leaders [will] put rationalism and wisdom above personal interests and ego, which sometimes unfortunately prevail over everything else.”

Nearly 16 million people in Sudan, a third of the country’s population, were in need of humanitarian assistance before the onset of the violence. Millions more are at risk of being driven into hunger if the conflict continues, the World Food Programme said, worsening the impact of the ongoing food crisis across the greater Horn of Africa.

The United Nations estimates around 20,000 people, mostly women and children, have already fled Sudan to the relative safety of neighbouring Chad, adding to the 3.7 million people internally displaced in the country.

“We are observing a traumatic deterioration in what is already a very difficult humanitarian situation,” Al Mandhari said. “The longer the fighting continues, the greater the consequences for the health and wellbeing of millions of people.” 

“There are no winners in this war,” he added, “and the biggest losers are the nation, the people, and the citizens.”

 

In mid-2021, India was crumbling under the pressure of an intense COVID-19 wave, caused by the Delta variant of the SARS-CoV-2. But at the same time, misinformation was spreading exponentially – adding to the fear and anxiety of the time.

Thousands of people were scrambling to find oxygen cylinders and hospital beds for their loved ones infected with COVID-19, while others were struggling to recover completely from a previous COVID-19 infection and did not know what was happening to their bodies. Mis- and dis-information about the virus were rampant, creating widespread chaos in the country. 

Watching this situation unfold in front of his eyes pushed Sai Charan Chikkulla to take matters into his own hands. 

“A man lost his mother to COVID-19 after being shunted from one hospital to another due to lack of a bed with oxygen supply. He saw his mother die in an ambulance waiting for an oxygen-bed in a big government hospital because he didn’t know where else to take his mother,” Sai Charan told Health Policy Watch. 

A regular user of Twitter, the 29-year-old Hyderabad-based entrepreneur immediately decided to pick up the phone and start dialling. His idea was simple: to call hospitals in the region, enquire about the bed availability and the criteria for admitting patients and post the information on Twitter with the relevant hashtags. 

Sai was not the only one leveraging the platform to do good during the pandemic in India. Several others across the country used their social media profiles for good during a wave that killed at least 240,000 persons in India. 

Twitter as a dashboard for hospital beds

“I used to collect data [of bed availability] from one hospital. I immediately posted on Twitter. Around 200 people reached out to me after that asking for more information on the availability of hospital beds. That’s when I realised the situation on the ground was horrible,” he recollected. 

Charan expanded his calls to cover more hospitals and eventually began focussing on government hospitals from across his state, Telangana, and posted the details on Twitter regularly. 

“The charges in government hospitals were lower and affordable to people. So I started collecting up to date information from these hospitals, the phone number of the person in charge there and posted on Twitter with their consent.”

 

Sai Charan getting an award from a state minister for his work during COVID-19.

His volunteering efforts also expanded to posting real-time, reliable and verified information about the availability and prices of treatments remdesivir and tocilizumab, which were in demand in India during the worst peak of COVID-19. 

Sai’s efforts led to at least 1,500 persons securing hospital beds during the time of need in Telangana. Acknowledging his work during this period, the Government of Telangana honoured him with a “COVID warrior” award in November 2021. 

For DVL Padma Priya, life has not been the same since April 2020 when she got her first COVID-19 infection. While getting tested for COVID-19 was challenging as she was not in one of the “high risk groups”, the period after recovery wasn’t a breeze either. 

“My sense of taste and smell did not return till July and in July, 2020, I fainted. I had gone grocery shopping and I completely blacked out,” she shared with Health Policy Watch. 

“My doctor put me on supplements and told me to drink more water, but I was having severe issues like with my heart rate since then and I had severe tachycardia and I would faint every time I would change positions.”

Long COVID unknown

At the time, long COVID was not as known and patients often faced gaslighting from the doctors or inconclusive diagnosis.

“Long story short, it took a lot of self-advocacy for myself because I was basically being told I am anxious. I had to advocate a lot for myself to finally find a good doctor in Hyderabad who ran a couple of tests and said, ‘It looks like you have some sort of autonomic dysfunction’,” she recollected. 

A media entrepreneur, Priya shared these experiences on Twitter and received solidarity from across the population who were also experiencing similar symptoms. 

This prompted her to start a group on the instant messaging platform Telegram, which became a forum for people to discuss their symptoms, doctor visit experiences and updated studies on long COVID. 

“We’ve had a lot of webinars with groups of experts like mental health experts, neurologists etc since they understand what the symptoms could be and what people need to be aware about long COVID.” 

At its peak, the group had around 500 members, who used the platform to share tips on how to advocate for oneself to the doctors and what to look out for after testing negative for COVID-19.

Padma also started a “Long COVID survivors India” handle on Twitter and Discord, mainly to disseminate information and create awareness among the people about the various effects of COVID-19 on the human body. 

Verified information as the right weapon

In April 2020, Vijay Anand, a Chennai-based techie was witnessing a barrage of fake news about COVID-19 being spread on WhatsApp and Twitter. The information being spread ranged from rumours around the spread of the virus in his city to “instant magic cures” against SARS-CoV-2. The urge to address these messages drove Vijay to use his Twitter account to do something meaningful. 

“I started looking into government data [on COVID-19 cases]. I could find a lot of people analysing similar data in the US and UK but couldn’t find anyone doing it in India at that time. I saw an information vacuum there and wanted to fill it,” he explained. 

In an interview to Health Policy Watch, he added that the idea was to study the pattern and interpret it into useful and actionable information. “I wanted to tell people what is really happening and if there is a need to panic or worry about the [COVID] wave.”

Vijay tweeted at least once a day with the data released by the government authorities and his analysis based on the numbers. His tweets often included details of the positivity rate and reproductive rate of the virus and the outlook for the next few days. 

“I used to follow a lot of epidemiologists from established organisations like the Indian Council for Medical Research (ICMR), the US CDC and the UK, to understand what they’re trying to do in the rest of the world,” he elaborated. “And I used to spend about two to three hours a day just reading white papers that were published on COVID-19 to arm myself with the knowledge.” 

Accepting that he is not a medical doctor and his messaging was inaccurate at times, Vijay was always open to correcting his tweets based on the feedback from experts. 

“So, because a lot of doctors and even senior experts follow me [on Twitter], they just give me some feedback and I just correct [the information I put out].”

His consistent analysis that focussed on cutting out misinformation and fake news earned him praise from several government officers. 

This article is part of a series to promote the UniteHealth Social Media Awards, which will showcase individuals and organisations who used social media to strengthen collective understanding of the pandemic and evidence-based responses. Learn more about the awards and vote until the end of the month.

Image Credits: Unsplash, Supplied.

Charles Gore(MPP), Petro Terblanche of Afrigen, Dr Tedros Ghebreysus, South African Health Minister Dr Joe Phaahla, and Anne Tvinnereim, Norwegian Minister of International Development, cut the ribbon to formally open Afrigen.

CAPE TOWN – South Africa’s Health Minister was somewhat embarrassed that his government’s decision to procure pneumococcal vaccines from an Indian company rather than local company Biovac became public during a high-level international meeting on the local production of mRNA vaccines in his country.

South Africa’s procurement decision coincided with a meeting in Cape Town this week of over 200 international delegates working with the mRNA technology transfer programme that was launched in June 2021 by the World Health Organization (WHO) and the Medicines Patent Pool (MPP).

The mRNA hub is based at South African company Afrigen, which has developed a COVID-19 vaccine based on Moderna’s recipe – albeit without Moderna’s help. Afrigen is passing this know-how to people from 15 other low- and middle-income countries (LMICs), and representatives of 14 of these countries participated in the five-day event.

Biovac, which is partly owned by the South African government, is Afrigen’s vaccine production partner, and it has been making Pfizer’s pneumococcal vaccine, Prevnar 13, since 2021.

Health Minister Dr Joe Phaahla explained on Thursday that the South African government is fully committed to building local vaccine development but that ministers were not involved in procurement decisions, which were governed by an Act of Parliament that civil servants were obliged to follow or face prosecution.

“But South Africa is in the process of reviewing its procurement policy to support local production,” Phaahla told the meeting.

Tensions between price and local production

While Biovac has expressed dismay at the decision, it is precisely this tension between price constraints and the drive to support more local production that countries, global vaccine procurement agencies and donors need to resolve if local vaccine and medicine manufacturing are to become a reality in regions like sub Saharan Africa, which are so lacking in this capacity today.

Unless governments and donor agencies are actually going to procure vaccines from regional manufacturers, the mRNA technology transfer will simply become lessons in science rather than a solution to structural manufacturing inequity.  But vaccines and medicines produced by new start-ups are also likely be more expensive than those produced by giant Indian or Chinese pharma firms that have been in the business for year and are already supplying large global markets. 

As Dr Blade Nzimande, South Africa’s Minister of Higher Education, Science and Technology, told the mRNA meeting, while, technology transfer is necessary, “this is not sufficient”. 

“We need government support, and this includes the willingness to invest in research and development, building of human capacity, and willingness to pay a premium for vaccines, at least until we achieve economies of scale,” he added.

But is it realistic to expect that countries economically battered by COVID-19 will be willing and able to pay this premium when generic companies such as India’s Cipla can deliver vaccines at a significantly cheaper rate?

South African health officials told Health Policy Watch that the decision to give a three-year contract to Indian generic company Cipla instead of buying Biovac’s vaccines would save the department so much money that it could introduce two new childhood vaccines.

Cipla – which has its vaccines made by the Serum Institute of India – publicly quantified the sums involved on Wednesday, saying that its contract with South Africa would save the government approximately $133 million (R2.4 billion) over its three-year lifespan.

Preferential procurement for African vaccines by global health agencies?  

WHO Director-General Dr Tedros Adhanom Ghebreyesus described the tension between the government and Biovac as a “heads up” that the same problem could arise for mRNA vaccines.

“It’s good that this happened now, so you can prevent it from happening, especially for this big and very strategic initiative,” said Tedros, who added that there had been a “very candid discussion” that morning with key mRNA hub partners.

Nzimande said that the Finance Ministry was busy amending its “preferential procurement” legislation in South Africa, including how to balance price and local production.

“This is a very complex issue. Sometimes you may find that an international company is cheaper than a local company because it is actually being subsidised by the government in its own country, and we are not doing the same thing. We might have to pay more sometimes because we want to build local capacity.”

While Tedros expressed support for preferential procurement to support local vaccine start-ups in their infancy, he added that this should be established at a “regional and continental level”, starting with Africa’s free trade zone.

At a global level, Tedros said that WHO, Gavi, UNICEF and other international organisations would also need to support Africa’s production. 

Indeed, after decades of chasing vaccines and medicines at the lowest price possible – no matter where they were produced, Gavi late last year committted to diversifying its procurement and purchasing more African health products. But that commitment remains only on paper, critics say. Actual implementation of plans to buy locally produced vaccines in Africa is being confined to a separate budget designated for funding pharma startups, and requiring more donor funds. 

Phaala conceded that “innovative funding mechanisms will be required, both in the short, medium and long term to assure sustainability”, and proposed that “appropriate trade incentives” could be used to build “more secure demand so that this industry can grow beyond our borders”. 

But he also said that South Africa was looking to the WHO, Gavi and the COVAX facilities for support.

Meanwhile, Nzimande said that approaching international partners to subsidise prices of products that are produced locally in South Africa is a good idea. This has been done on a time-bound basis of 10 years for the pneumococcal vaccine.

Significant investment required

South African Health Minister Dr Joe Phaahla, and Anne Tvinnereim, Norway’s Minister of International Development.

International donors have invested heavily in building the capacity of the African mRNA hub, mainly in reaction to the COVID-19 pandemic. Africa was isolated and vulnerable after the Indian government forbade the export of generic COVID-19 vaccines during the height of its pandemic, leaving the continent without access to COVID-19 vaccines as it imports 99% of its vaccines.

There was global recognition that building Africa’s vaccine manufacturing capacity is essential to prepare for the next pandemic, and idea of a hub to manufacture and train others germinated in the WHO and the Medicines Patent Pool (MPP).

The idea has been attractive to wealthier countries. The European Council alone has invested €40 million in the hub, and recently signed an additional €15.5 million grant with the European Investment Bank to facilitate the expansion of Biovac’s vaccines manufacturing capacity, said Martin Seycell, Deputy Director General of the European Council.

Canada has so far invested $45 million in the hub, and Caroline Delany, GlobalAffairs Canada’s Director General for Southern and Eastern Africa, announced a further commitment of $15 million on Thursday.

Norway and South Africa developed a special relationship during the pandemic as co-chairs of the Access to COVID Tools (ACT) Accelerator, and Norway’s Minister of International Relations, Anne Tvinnereim, stressed that the mRNA hub was part of a bigger ecosystem aimed at preparing for the next pandemic.

“Different parts of this system must be strengthened to facilitate increased local and regional production of vaccines, and the key will be to ensure that production capabilities will be commercially sustainable. This includes the production of other types of vaccines in non-pandemic times,” said Tvinnereim.

“South Africa and Norway follow the discussions on pandemic preparedness and a platform for medical countermeasures very closely,” she added, stressing that lessons learnt during the pandemic needed to be taken forward to the United Nations High Level Meeting on pandemic preparedness and response in September.”

Afrigen inauguration

Afrigen Executive Director Prof Petro Terblanche and scientists wait for the arrival of Dr Tedros.

Following the briefing of the mRNA hub meeting, Tedros and the international team headed to Afrigen to formally open the facility.

Waiting for the delegation was Afrigen Executive Director Prof Petro Terblanche, who said that the hub’s COVID-19 vaccine candidate, AfriVac 2121, “is currently in the scale-up phase”.

“Over the last 18 months, Afrigen has undergone an incredible transformation with the support of a network of partners and mentors enabled by this programme,” she added.

“We have grown our capability and capacity to meet the highest quality standards of mRNA vaccine development, serving the objective to build sustainable capacity in LMICs to produce mRNA vaccines.”

Afrigen is currently manufacturing vaccine batches to be used in Phase I/II clinical trials to good manufacturing practice standards, while also continuing with training and technology transfer to network partners.

Image Credits: WHO, Kerry Cullinan.

The World Health Organization (WHO) has launched the largest global collection of publicly available disaggregated data on health inequality, which aims to empower public health officials to conduct more targeted responses to health threats. 

Composed of over 11 million data points, the Health Inequality Data Repository (HIDR) is the first open-source tool to allow for the tracking of health inequalities between population groups over time. 

“Disaggregated data – which show how health or other aspects of life are experienced by people of different ages, economic status, education levels, place of residence, sex, and other characteristics – are a vital part of advancing equity,” WHO said. “To achieve equity, we first need to know where inequalities are.”

The lack of precise data on health indicators has long been a major challenge for global health officials. Despite constant calls by WHO for countries to improve their data collection and reporting systems, disaggregated data is still not available for many dimensions of health inequality. Only half of the qualifying Sustainable Development Goals, for example, are tracked with disaggregated data. 

When data exists, it is most frequently broken down only by sex, and occasionally by age and place of residence, limiting the ability of health authorities to calibrate their policy responses to target those most in need of assistance. 

The HIDR data set contains statistics on over 2000 health indicators relating to the Sustainable Development Goals, COVID-19, immunization, reproductive, maternal and child health, infectious diseases like HIV, tuberculosis and malaria, and other health threats, broken down into 22 dimensions of inequality along demographic, socioeconomic and geographic lines. 

Armed with more precise information about which populations require the most help, global and national health officials can make more informed decisions, increasing the impact of often limited resources. 

“If we are truly committed to leaving no one behind, we must figure out who is being missed,” WHO Director-General Tedros Adhanom Ghebreyesus said. “The ability to direct services to those who need them the most is vital to advancing health equity and improving lives.”

Along with the launch of the database, WHO issued a call to governments to redouble their efforts to adopt routine health inequality monitoring and expand data collection capacities.

“Inequality analyses should be conducted regularly at the global, national and subnational levels,” the WHO said. “Inequality data can save lives by identifying who is left behind.”

Professor Kelly Chibale at the Holistic Drug Discovery and Development (H3D) Centre at the University of Cape Town in South Africa.

Access to universal healthcare remains a global challenge and even more pressing in the African region. While African-based researchers, scientists and innovators have the capability to make significant contributions towards building homegrown solutions, the continent lacks adequate financial investment in innovative pharmaceutical research and development (R&D).

To achieve the African Union’s Agenda 2063 for a bold transformation of the continent, we need to take action now.  

Coming off the heels of the recent  African Innovation for Inclusive Healthcare webinar hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the Holistic Drug Discovery and Development (H3D) Foundation, it is important to continue exploring how the African science and innovation community can be scaled up to capacitate the continent’s R&D to play a more effective role in responding to local health challenges. 

The webinar illustrated the successful drug development partnerships across the industry, government and academics in South Africa. 

Homegrown solutions should be at the heart of this ecosystem we want to build. We know that the continent’s public healthcare system and health innovation ecosystem face numerous challenges including limited access to medicines, competitive technologies, shortage of a critical mass of skilled personnel and inadequate funding. 

Underfunding

In 2006, African Union member states committed to spending 1% of their GDP on R&D. However, this is still not the case. African countries still vastly underfund their R&D efforts. According to a report from UNESCO, no country in Africa is spending 1% of its gross domestic product (GDP) on R&D, although spending on science has increased globally in the past five years. The report also highlights that while Africa has 16% of the world’s population, it only has 1.3% of the world’s researchers.

We’ve got our work cut out for us, but we have made some inroads. We’ve found that the best way to curb these problems is to build collaborations and strengthen existing capabilities. 

The Holistic Drug Discovery and Development (H3D) Centre, which I lead, provides avenues for research institutions to collaborate and work together to leverage our different capabilities and mobilise funding together. The past five years have taught us that we can transform and strengthen the capacity of historically disadvantaged institutions in South Africa and effectively expand the drug discovery community across the continent through partnerships and industry – and academic-led mentorship. 

At our webinar, I was pleased to hear Elizabeth V Mumbi Kigondu, Principal Research Scientist, Centre for Traditional Medicine and Drug Research at Kenya’s Medical Research Institute, say that this “will allow us to ensure that we have medicines and products coming from Africans and solve African health problems.”

Building on these partnership models, we recently partnered with the University of Limpopo and the University of Venda on tuberculosis (TB) research initiative to boost local TB research while also accelerating capacity development at these historically disadvantaged institutions.

Training scientists is one of the key tasks of H3D.

With these projects, H3D continues to address the challenges in capacity building by training local scientists – creating a steady stream of skilled scientists to generate African-led scientific knowledge while simultaneously closing the gaps in the local science and research sectors.  While building facilities is important, it is equally important to cultivate a skilled workforce to utilise these resources effectively.

The key to driving health innovation in Africa is in strengthening human resources through science mentorship. As a J&J Satellite Centre for Global Health Discovery, H3D has partnered with the company to harness the best scientific talent in Africa and to mentor them in boosting H3D’s antimicrobial resistance (AMR) drug discovery portfolio, which will eventually attract more projects and investments. These mentorship programmes foster a culture of innovation and entrepreneurship that encourages the development of new technologies, products and services.

Having highlighted the importance of partnerships and collaborations in African R&D innovation, it is equally crucial to discuss the role of financial investment in this sector as it provides access to resources that drive R&D, technology transfer and entrepreneurship. 

Manufacturing active pharmaceutical ingredients

H3D has recently been granted funding from the United States Agency for International Development (USAID) to boost medicines manufacturing in Sub-Saharan Africa. The fund through MATRIX will support a pilot project that will evaluate innovative technology for the cost-effective manufacturing of active pharmaceutical ingredients (APIs) in South Africa.

While the South African pharmaceutical formulation industry is well developed and produces more than half the final pharmaceutical product consumed locally, the country does not have the capacity to synthesise and manufacture APIs. 

To address this challenge, H3D has partnered with an international group of scientists and a local API manufacturing company, Chemical Process Technologies (CPT) Pharma, to develop a creative approach that, if successful, could revolutionise the manufacturing of medicines in South Africa, and the rest of the continent.

This collaboration will facilitate both technology transfer and on-the-job skills development and forms a crucial role in seeding new industrial development that is so critical for absorbing the abundant labour force available in South Africa.

While there is no silver bullet, these are perhaps valuable lessons for the types of health innovations that the continent can produce when vested interests are aligned towards the same goals, particularly considering Africa’s longstanding manufacturing scarcity and the urgent need to scale up R&D efforts.

With continued funding and support for African science, research, and development innovation, Africa’s capacity for R&D and innovation will increase and this will drive progress in achieving quality healthcare for all.

Professor Kelly Chibale is the founder and Director of the Holistic Drug Discovery and Development (H3D) Centre at the University of Cape Town, South Africa.

 

Image Credits: Kerry Cullinan.