Healthworkers raise awareness of Ebola virus in the community in Beni, DRC. Massive recruitment of a predominantly male emergency teams, inadequately screened or trained, created the conditions for sexual abuse to flourish alongside the virus, the Independent Commission found.

A WHO independent commission concluded  that 83 emergency responders to DR-Congo’s 2018-2020 Ebola outbreak, including some 21 WHO employees and consultants, had likely abused dozens of Congolese women, obtaining sex in exchange for promises of jobs – also raping nine women outright.  

But the panel’s findings, which validate reports first published in September 2020 in an investigation by the New Humanitarian and Thomson Reuters Foundation, were billed as only a first step of investigations  – with no judgments or sentences meted out – or high-level WHO managers yet named as accountable.  

“Acts took place in hotels and in other cases in houses rented by the presumed perpetrators.  Most of the victims heard by the review team were women – but 12 men also said they were victims of sexual abuse and exploitation,” said Malick Coulibaly, a former Minister of Justice of Mali, speaking at a press briefing on Tuesday. 

Coulibaly was one of the members of the five-person panel commissioned to investigate claims by some 75 women, against 25 WHO staff and other UN workers, during the 2018-2020 Ebola crisis in Ituri and North Kivu provinces.

An inquiry directed by the commission interviewed some 3063 women witnesses, aged 13-43 years, along with 12 men – all alleged to have been exploited and abused by the Ebola response teams that included about a dozen other UN organisations and NGOs, coordinated by WHO with the DRC government. 

WHO Africa Regional Director Matshidiso Moeti, who personally supervised much of the massive WHO response to the deadly Ebola outbreak in DRC’s North Kivu and Ituri provinces that killed some 2299 people, said the report had left her “humbled and horrified.” 

Field Staff recruited without background checks 

Malick Coulibaly, former Minister of Justice and President of the National Human Rights Commission, Mali.

The circle of sexual abuse cases multiplied as large numbers of local and international staff were recruited by WHO to combat the outbreak – “without call for tender “& without background checks”  Coulibaly said. 

He recited a long litany of allegations first reported in the press and confirmed by the commission, including rape, perpetrators’ refusal to use protection, forced abortions, and intimidation: 

 “Victims were promised jobs in exchange for sexual relations, in order to be able to keep their jobs.” Coulibaly said. 

“Most victims were in a very precarious, economic and social situation during that response. Very few had completed secondary education, some had never gone to school at all.  

“Most victims did not get the jobs that they were promised in spite of the fact that they agreed to sexual relations. Some women declared that they continue to be sexually harassed by men. And they were obliged to have sexual relations to be able to keep their job, or even to be paid, and some were dismissed for having refused sexual relations, 

The WHO perpetrators included staff medical officers and consultants recruited both locally and internationally – as well as some drivers and security personnel, the commission found, 

In 29 of the cases investigated, Congolese women became pregnant at the hands of their abusers, with 22 women giving birth while others were forced by their abusers to abort, Coulibaly added. Nine victims also said they were raped. 

“In spite of poignant narratives of the SEA victims, most perpetrators denied the facts & even stated that the sexual relations were consensual,” added Coulibaly. “Everything contributed to increased vulnerability of the alleged victims – they did not benefit from aid and assistance.” 

Higher-level WHO coverup? Report Leaves questions unanswered 

WHO Director General Dr Tedros Adhanom Ghebreyesus

WHO’s Director General Dr Tedros Adhanom Ghebreyesus called it “harrowing reading” and said he held himself personally responsible. 

But Tedros, who visited DRC 14 times during the Ebola outbreak, also said that he had never heard word of the widespread abuse when he was in DRC on the ground.

“The issue was not raised to me, probably I should have asked questions. As for the next steps.  What we’re doing is we have to ask questions,” he said.

In the written report published Tuesday, the Independent Commission said that it had “”no information at this time that would give rise to personal responsibility on the part of Dr Tedros Ghebreyesus, Dr Michael Ryan or Dr Matshidiso Moeti in relation to wrong handling of incidents of sexual exploitation and abuse by WHO staff or in relation to allegations of sexual exploitation and abuse published in the press.”

Investigation of any senior WHO staff left to WHO internal justice  

Aïchatou Mindaoudou, former Minister of Foreign Affairs and of Social Development, Niger.

All but four of the WHO staff and consultants alleged to have been  directly involved in the abuse were no longer working for the organization – and those last four were recently terminated, the director-general added, noting many of the alleged abusers were on short-term emergency contracts in the first place.  

Two senior WHO staff also have been placed on leave while an investigation proceeds about their possible role in alleged cover-up of the sexual abuse activities in DRC, Tedros also confirmed. “And we have taken steps to ensure that others who may be implicated are temporarily relieved of any decision-making role.”   He did not name names.

But the Commission’s work, which included over 3,000 interviews on the ground in DRC, stopped short of detailed examination of WHO staff in Geneva or regional offices, who may have sanctioned or protected colleagues involved in the abuse. 

“We did not know, at the beginning of our investigation, that there were some at higher level, who were aware of what was going on, and did not act.  We only discovered this during our investigation,” said Dr Aichatou Mindaoudou, a UN special representative in the Ivory Coast, and Commission co-chair.  

Julienne Lusenge, DRC human rights activist and commission co-president.

Julienne Lusenge, the Commission’s other co-chair, said the group’s mandate had been to confirm the existence and extent of the sexual abuse allegations, first reported in the media September 2020 and again in May 2021. It lacked any mandate to judge and mete out sentences to the perpetrators.   

“It is now up to the WHO,” Lusenge said. “They are going to have a mechanism to be in charge of a deepening investigation … it is not up to us to say this person should be arrested and sentenced.”

The Commission did recommend, however, a range of follow-up measures, including reparations to victims, genetic testing of alleged abusers and their  offspring, as well as  an overhaul of WHO hiring practices and sexual exploitation and abuse (SEA) training, as well as of the ways in which the internal justice system responds to alleged victims with claims.

Speculation about high-level WHO cover-up has revolved mostly around the WHO Emergencies Official, Michael Yao, who was reported by the Associated Press to have received a series of confidential emails naming some of the alleged abusers, including Dr Boubacar Diallo – but did not take action against the alleged perpetrators. 

Diallo described by colleagues as having connections to WHO’s senior leadership, reportedly denied the wrong-doing. In one WHO photo, Tedros, Yao and Diallo are pictured smiling together during one of Tedros’ trips to Congo during the Ebola outbreak.   

Neither man was mentioned by name at Tuesday’s media briefing.  But the panel’s written report does refer to the “case of M. Boubacar Diallo, stating that “Dr Tedros Ghebreyesus, during his interview with the investigators, acknowledged that he had instructed Mr David Webb, who had come to inform him in January 2021 of incidents involving Mr Diallo, to defer any internal investigation until the publication of the conclusions of the Independent Commission and to transmit to the latter all the information at his disposal. This version of events is consistent with that given by Mr David Webb to the review team.”

The report leaves open the question of whether the investigation is continuing now.

June 16, 2019, Dr Boubacar Diallo, WHO Director-General, Dr Tedros Adhanom Ghebreyesus and WHO Emergency Response Team leader, Dr Michel Yao, pose for cameras during a visit to DRC by the WHO Director General.

Sweeping Reforms Needed – And Survivor Support  

At Tuesday’s presser, Tedros pledged an overhaul of the current policies – saying that the investigation would lead to sweeping reforms in the process of staff recruitment and sensitization around sexual abuse issues.

Along with terminating the contracts of four alleged perpetrators still employed by the organization, WHO is pursuing investigations of still unidentified perpetrators, and would refer allegations of rape to national authorities in DRC or elsewhere, he added.

It’s a “sickening betrayal of the people we served… a dark day for WHO,” Tedros said. “But we want the perpetrators to know that there will be severe consequences for their actions. We will hold all leaders accountable for any suspected incident.“

“We will undertake wholesale reform of policies and processes to address sexual exploitation and abuse,” Tedros added. “But we must go further to identify and address any shortcomings in our culture or leadership that failed to adequately protect the people we serve.”

Gaya Gamhewage, WHO director of Prevention and Response to Sexual Exploitation and Abuse

Gaya Gamhewage, WHO’s Director of Prevention and Response to SEA, said that the organization also would seek funds to help rehabilitate vulnerable women and the children born to them, as a result of the abuse.  

“We need funds on the ground for victim & survivor support,”  Gamhewage said, noting that as of now:  “There is no provision in the UN system for financial reparations to the SEA victims. But that does not stop us from making sure funds are allocated for support & assistance as we move forward.”

Until now, that is support has been far from forthcoming, Coulibaly observed, saying: 

“In spite of poignant narratives of the SEA victims, most perpetrators denied the facts & even stated that the sexual relations were consensual. Everything contributed to increased vulnerability of the alleged victims – they did not benefit from aid and assistance.” 

Image Credits: WHO/Chris Black, Twitter/@OMSDRCONGO, WHO.

Mothers take their babies to receive vaccinations at a mobile unit in Molumbo district, Mozambique.

The World Health Organization (WHO) aims to eliminate bacterial meningitis by 2030, primarily by increasing access to vaccinations and treatment.

This emerged at Tuesday’s launch of the first-ever global ‘roadmap’ to tackle the disease, which causes inflammation of the membranes that surround the brain and spinal cord, mainly as a result of infection from bacteria and viruses.

Around a quarter of a million people – mostly children – die from meningitis every year, while one in five of those infected suffers from long-lasting disabilities including seizures, loss of hearing and vision, and cognitive impairment.

“Wherever it occurs, meningitis can be deadly and debilitating; it strikes quickly, has serious health, economic and social consequences, and causes devastating outbreaks,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. 

“It is time to tackle meningitis globally once and for all –by urgently expanding access to existing tools like vaccines, spearheading new research and innovation to prevent, detecting and treating the various causes of the disease, and improving rehabilitation for those affected.”

 

Twenty-six countries in sub-Saharan Africa are known as the ‘meningitis belt’ because of the frequency of outbreaks.

“More than half a billion Africans are at risk of seasonal meningitis outbreaks but the disease has been off the radar for too long,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. 

“This shift away from firefighting outbreaks to strategic response can’t come soon enough.” 

Four organisms are responsible for 50% of deaths – Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae and group B streptococcus. 

Effective vaccines that protect against disease caused by the first three organisms are currently available and research is underway to develop vaccines group B streptococcus bacteria

But not all communities have access to these lifesaving vaccines, and many countries are yet to introduce them into their national programmes.

High immunization coverage, speedy diagnosis and optimal treatment for patients, data-driven prevention and control and better care of those affected are key pillars of the new strategy.

The roadmap follows the first resolution on meningitis passed by the World Health Assembly and endorsed unanimously by WHO member states in 2020.

“The meningitis roadmap provides a clear blueprint for defeating this devastating disease,” said Professor Robert Heyderman, head of infection research at University College London.

“Crucially it identifies the gaps in our knowledge and the tools required. To achieve the Road Map’s ambitious goals, a team approach will bring together countries, global policymakers, civil society, funders, researchers, public health specialists, healthcare workers and industry to generate and implement innovative new strategies.”

 

Image Credits: © UNICEF/Claudio Fauvrelle.

Health workers in Cape Town, South Africa, getting vaccinated against COVID-19.

As Africa waits for COVID-19 vaccines promised by the US and other countries to arrive, the continent’s Centers for Disease Control (CDC) plans to scale up antigen testing to identify and address pandemic hotspots.

“We are only at 4% vaccination rate, which means we have to continue to advance basic public health tools at our disposition, including rapid antigen test scale-up and enhanced community work so that we can know exactly where the hotspots of this virus are and flush it out while waiting for vaccine coverage to increase,” said John Nkengasong, Africa CDC Director, late last week.

He added that Africa CDC and partners would be launching its “2.0 response plan” in the coming weeks that aimed at scaling up testing, and expanding the outreach of community health workers. 

“There can be no doubt we need to test at scale, and we need to decentralise testing and put it in the hands of our community health care workers,” added Nkengasong in an address to an international audience organised by the US Ambassador to the African Union and the International Federation of the Red Cross and Red Crescent Societies (IFRC).

He added that, over the past 18 months, over 18,000 community health care workers had been deployed in 38 countries to conduct about 2.6 million household visits. They had also  conducted around 1.6 million tests to identify those who are infected, and their contacts.

Nkengasong described community health care workers as the “nexus for universal health coverage and health security”, essential to fight the current pandemic and to prepare for subsequent disease outbreaks.

Although there is an assumption that Africa has been comparatively less affected by COVID-19 infection than other regions, excess mortality figures of the few African countries that monitor these figures – notably Egypt and South Africa – indicate a huge under-estimation of the impact of the pandemic.

A recent comparison of World Bank regions put the Middle East and North Africa as the third-worst affected region in the world after Latin America and South Asia.

Meanwhile, Egypt outstrips a number of hard-hit countries including the US on excess mortality.

There has been an increase in demand for COVID-19 vaccines across Africa in the past few weeks – from Zimbabwe to Morocco, according to Nkengasong.

However, he acknowledged that in some countries, including Uganda, there had been a slowdown in demand.

“We will be looking at those countries to understand why the uptake has slowed, and what can we do with the community and religious leaders to improve uptake of vaccines, and create champions – sport, celebrities, and local musicians – to promote vaccines.

Image Credits: Western Cape government.

Clockwise from left-right: Richard Hatchett, Coalition for Epidemic Preparedness Innovations, Clemens Martin Auer, President EHF-Gastein, Ahmed Ogwell Ouma, Africa CDC; Hans Kluge, Director, WHO European Region

Multilateralism has “failed” to help Africa solve the COVID crisis and regional approaches to solving common problems could help the continent forge a “new public health order” said Africa Centers for Disease Control Deputy Director Ahmed Ogwell Ouma, speaking at the opening of the European Health Forum- Gastein. 

His statement at at the traditionally “Eurocentric” conference, palpably illustrated the way in which lack of access to COVID-19 vaccines and treatments is forcing leaders on the continent to look inward for new solutions – following the failure of international initiatives like the COVAX vaccine facility to bring adequate responses. 

The five-day European forum, which traditionally draws hundreds of participants from across the region to the Austrian spa town of Bad Gastein every autumn, is happening this year on an primarily virtual platform. 

But the conference, taking place under the slogan, “Rise Like a Phoenix” – Health at the Heart of a Resilient Future for Europe still includes the rich array of European and global health policymakers for which the forum has become known, including Stella Kyriakides, European Commissioner for Health and Food Safety, the European Medicines Agency’s Emer Cooke and WHO’s Director General Dr Tedros Adhanom Ghebreyesus. 

It also features a wide range of global health trend-setters, such as Michael Marmot, of University College London, who led WHO’s cutting edge work on the Social Determinants of Health a decade ago and Wellcome’s Sir Jeremy Farrar, who has been a leading voice on policy challenges around the pandemic.  And there are dozens of experts presenting at, or attending, more specialised sessions covering topics ranging from brain health to marginalized groups, to a new “Oslo Medicines Initiative” which aims to foster new modes of public-private collaboration wider facilitating access to more affordable medicines. 

New public health order should be part of ‘Pandemic Treaty’

Ahmed Ogwell Ouma, deputy director general, Africa CDC, at Gastein Forum

But the kickoff sessions were a vivid reminder that Europe is not an island – and that the failures of regions like Africa to get access to critical COVID tools and treatments – are echoing in the global north and beyond.  

“Where we sit here at Africa CDC, indeed on the African continent, multilateralism has failed,” said Ouma, at a press briefing opening the conference’s first day, and just after WHO Regional Director Hans Kluge made a plea for European countries to share excess vaccine doses with low- and middle-income countries  – in the spirit of multilateralism.  

“It [multilateralism] has been very successful in meeting rooms and webinars and probably some negotiating tables, but on the ground in Africa, it has failed,” retorted Ouma.  

 “Going down the path of regionalism,” may be more effective now, Ouma remarked, “where  neighbouring countries who share the same aspirations, countries who are willing to support each other during good times and bad times, can be able to come together and work towards a common good.”

He said that Africa needs to aspire to a “new public health order, including four key pillars:

  • Strengthened African health institutions at regional and country level;
  • A stronger African health workforce;
  • More reliable supply chains for medicines, vaccines and equipment, including more local manufacturing capacity;
  • Global partnerships that are “respectful and action-oriented.”

All of these elements should be incorporated into negotiations for a new Pandemic Treaty, or revisions in the existing WHO International Health Regulations, which current governing health emergency responses.

“Is a new treaty necessary?  We can discuss that if it captures these four points,” he said.  “Is reviewing of the IHR necessary? Absolutely.  We have seen a spectacular failure of the IHR. But we must tackle what is wrong and not just what is convenient to discuss.”   

Warns against regional competition

Ilona Kickbusch, Founding Director of the Graduate Institute’s Global Health Centre in Geneva.

At the same time, Ilona Kickbusch, founding director of the Geneva Graduate Institute’s Global Health Centre, said that regional solidarity should pave the way to more effective global cooperation. A stronger and better financed World Health Organization, and new collaborative frameworks such as a proposed ‘European Health Union’ consolidating national health agencies regionally, could help go beyond the rhetoric.

“The pandemic has shown that there were at least three areas in which we cannot afford not to work together globally. That is global health, the environment, and the digital transformation,” said Kickbusch.

“All three hang together to bring better health to people all around the world.

“It has become clear that regional efforts are ever more important to bring countries together and to develop new initiatives,” she added.  “However, regions should not compete with one another but rather work together at a multilateral level….. This is why we hope that the European-African partnership, that already exists, will be slowly strengthened through better financing and will lead to a new kind of global coalition that will be absolutely critical”.

Kluge – On boosters & dose-sharing – 1.2 billion excess doses means there are enough “to do it all”

The Austrian alpine setting which usually hosts hundreds of EHF-Gastein participants – this year was the setting only for a video clip and key conference organizers/ presenters.

Touching on the controversial issue of COVID vaccine boosters, Kluge veered away from the line of his boss, Dr Tedros, who has repeatedly called for a booster moratorium, in order to free up more supplies to reach the global south.

Instead, Kluge asserted that there should be enough vaccines to go around if they were used more efficiently – quoting United States Chief Medical Advisor Anthony Fauci who said in August that “we should do it all” – providing boosters to already-vaccinated groups in high-income countries – as well as vaccinating the world.

“My principle has been, and this was the same principle as … Dr. Anthony Fauci whom I discussed this with in August, from my mission to Washington, is: “Do it all,” declared Kluge at the presser kicking off the first day’s proceedings.

He pointed out that by end 2021, rich countries will have amassed an excess of 1.2 billion vaccine doses – if they don’t share them. “So the key issue is the political leadership and coordination to get them to those countries in need.”

One key barrier to more efficient distribution, Kluge added out, has been that countries often prefer to share their excess doses “based on geopolitical considerations, instead of a need basis:

“While I understand this, there has to be a bit of a balance.”

Another obstacle, is that countries are “waiting too long to share their excess doses – too close to expiry dates, and then for the receiving countries, this is too difficult.”

At the same time, he added that recent research has suggested that expiry dates may be extended under the right circumstances, noting a recent decision by Israeli authorities to extend the shelf life of Pfizer vaccines from a total of six to nine months.

He also said that receiving countries need to do their part: “to do the homework to register the new products and the manufacturing sites” – although he did not elaborate as to what countries in the global south may have been slow to register new vaccines or  manufacturing sites.

Overall, however, the biggest problem is political leadership to unlock more massive quantities of excess doses, he stressed:

“I mean, it’s nice that countries say 1 million, sharing, and 300 million sharing, but we should be sharing in terms of billions…And that’s what we need.”

Image Credits: European Health Forum Gastein.

digital learning
President of France Emmanuel Macron, speaking at the launch of the WHO Academy

The World Health Organization (WHO) Director-General Dr Tedros Adhanom Gheybreyesus and French President Emmanuel Macron today broke ground at the launch of the first WHO Academy in the French city of Lyon. 

The Academy fulfills a commitment by the two leaders to make WHO training more widely available to member states, and more systematically offered across various new digital media channels. 

“The ambitions of the WHO Academy are not modest: to transform lifelong learning in health globally,” said Dr Tedros. “The COVID-19 pandemic is a powerful demonstration of the value of health workers, and why they need the most up-to-date information, competencies and tools to keep their communities healthy and safe. 

He added: “The WHO Academy is an investment in health, education, knowledge and technology, but ultimately it’s an investment in people, and in a healthier, safer, fairer future.”

This initiative is one of a number of WHO projects in collaboration with major European countries in a new wave of science and diplomatic collaborations that notably coincide with France and Germany’s co-sponsoring of Tedros’ candidacy for re-election. 

Recently, the WHO and the German government launched a pandemic surveillance hub in Berlin.

Training for those ‘on the ground’

From its campus in Lyon, the Academy will provide millions of people around the world with rapid access to health training tailored to meet the needs of those “on the ground”, Academy Executive Director Agnes Buzyn said during the launch event Monday. 

“We want to have a wealth of programs, we want to have a real portfolio, which will be relevant for a whole range of health care professionals and health care workers.

“But of course this has to meet people’s needs, so out on the ground we need to really take stock of what those needs are so that we can adapt to them and provide the kind of skill and competences that it’s needed to improve healthcare worldwide.”

The academy will be made available via desktop and mobile devices in low-bandwidth settings, ensuring a global and diverse cohort. 

Additionally, the academy will: harness new high-impact technologies such as virtual reality, augmented reality, artificial intelligence; formally recognize “digital credentials” to help participants advance their careers; and offer more than 100 major learning programs by 2023, with credentialled programs for COVID-19 vaccine Equity, Universal Health Coverage, Health Emergencies and Healthier Lives. 

COVID-19 – ‘Motor of Innovation’ for digital learning

WHO Director-General Dr Tedros Adhanom Gheybreyesus

The COVID-19 pandemic has disrupted in-person learning systems, generating a growing demand for digital learning, and may be a crucial step in advancing WHO guidance and health solidarity in low- and middle-income countries. 

“The guidance we give has not always delivered the impact as it should in countries. Too often it sits on the shelf or in an overworked health administrator’s inbox and isn’t fully implemented. The norms, the guidance we prepared – we need to find ways of making sure WHO guidance is applied faster and delivers results faster,” said Tedros.

Emmanuel Macron also noted that this partnership would allow France to reach out to those in the African continent to train healthcare professionals in order to “have true health solidarity at a global level.” 

“You cannot emerge from an international crisis or pandemic without solidarity, and this crisis really was the motor of innovation.”

Image Credits: WHO.

White House virtual summit proceedings Wednesday saw high-minded declarations – will action follow?

US President Joe Biden has reaped praise for convening a Global COVID-19 Summit on the margins of this year’s United Nations General Assembly that placed vaccine shortfalls in low- and middle-income countries front and center of GA debates. But it remains to be seen if the big commitments repeated once more this week can break through the glass ceiling of inertia fast enough to meet WHO’s goals of 40% vaccine coverage in every country by the end of this year.  

Statements from Geneva Friday by the World Health Organization, the WHO-backed COVAX global vaccine facility, and other mainstream actors reflect that uncertainty between the lines – while those by civil society were more openly critical.

Together, they underline the complex steps that still need to be taken to quickly turn around the vaccine distribution dynamics. 

And that includes not only the immediate fulfillment of unmet donation pledges, but also prioritization of vaccine finance for vaccine purchases by low- and middle-income countries, rather than on their behalf, COVAX says.  Infrastruture and IP frameworks to enable more rapid expansion of vaccine manufacturing in LMICs remains a sticking point with equity-minded civil society groups, meanwhile. 

Expired vaccine doses are killers

Data released just ahead of the White House COVID-19 summit, Wednesday, underlined once again the waste and lives lost in a business-as-usual approach – including continued stockpiling by rich countries of excess vaccine doses, including 100 million due to expire by the end of the year.  

Rapid deployment of those 100 million doses to vaccine starved low- and middle-income settings could avert almost 1 million COVID deaths, according to projections by the science analytics firm Airfinity, which created a series of vaccine supply forecasts coinciding with this week’s high-level meeting on the pandemic response.

WHO – ‘success depends on action now’   

WH0 Director General Dr Tedros Adhanom Ghebreyesus speaking at the COVID-19 vaccine summit

In a briefing note at the close of the Summit, the White House appeared determined to turn around such gloomy forecasts. 

The White House said world leaders had “answered the President’s call and embraced a set of ambitious global targets,” including top-line targets such as:  

  • Vaccinate the world: Support the WHO’s goal of at least 70 percent of the population fully vaccinated with quality, safe, and effective vaccines in every country and income category by UNGA 2022.
  • Deliver doses urgently: Endorse the G20 target of, “in line with the World Health Organization (WHO), we support the goal to vaccinate at least 40 percent by the end of 2021 of the global population.”
  • Manufacture doses over the medium and long-term: Additional doses and adequate supplies are available to all countries in 2022. As scientific evidence develops, make sufficient financing available for production of additional doses for future booster needs in LIC/LMICs.

“The leadership shown by President Biden is commendable and provides a much-needed boost to the global efforts to rapidly expand access to vaccines, scale up diagnostic testing and expand supplies of oxygen and other life-saving tools in all countries – especially the most vulnerable,” said WHO Director Dr Tedros Adhanom Ghebreyesus, in a statement issued Friday evening, but “success depends on action being taken now.”

“The commitments made at the Summit offer the promise of reaching the targets that the World Health Organization and its partners have set to vaccinate 40% of the population of all countries by the end of 2021 and 70% by the middle of next year,” he added, saying ““to quote President Biden, ‘we can do this.’”

However, to reach this year’s target, the world needs 2 billion doses for low- and lower- middle income countries “now,” Tedros stressed in his post-summit statement.

COVAX facility – Finance for vaccine purchases rather than donations  

Ursula Von der Leyen, president of the European Commission, announces the creation of a new EU and United States Global Vaccine Partnership – but can it deliver more efficiently ?

Advisors to the COVAX vaccine facility, which is supplying vaccines to low- and middle income countries, were not as upbeat. 

A statement Friday by the COVAX Independent Allocation Vaccine Group (IAVG), entitled “What Needs To Change”  hardly had anything to say about the Summit at all. Rather they group expressed continuing concern that “the low supply of vaccines to COVAX” still might leave the world short of the doses needed to reach 40% vaccine target for end 2021. 

“The IAVG is concerned about the 25% reduction in supply forecast for the fourth quarter of 2021. “It is also concerned about the prioritization of bilateral deals over international collaboration and solidarity, export restrictions and decisions by some countries to administer booster doses to their adult populations,” said the statement. 

To accelerate distribution efficiently, the global community also needs to prioritize funding for more vaccine purchases by low-income countries – rather than relying so heavily on vaccine donations, the IAVG added:  

“Donations to COVAX are an important source of vaccine supply; however, these should complement rather than replace vaccine procurement by COVAX given the high transaction burden and costs in managing these donations,” the IAVG stated, adding that purchases by NGOs should also be considered.   

The statement followed on the US-European Union joint announcement that they would create a Global Vaccine Partnership that would also create a new fund to finance vaccine donations – but not outright purchases by LMICs.

Swap delivery schedules with COVAX and stop earmarking donated doses

Additionally, the “IAVG strongly encourages high-coverage countries to swap their delivery schedules with those of COVAX so that COVAX contracts can be prioritized by manufacturers.”

And the IAVG stressed that countries which are sharing doses with COVAX to reduce/remove all earmarking and ensure the donated vaccines have an adequate remaining shelf life to allow for their use.

Civil society also wary of summit’s emphasis on donations & dose-sharing

Vaccine deliveries by the global COVAX facility, led by WHO and Gavi, and supported by a consortium of global health organizations.

The White House position papers also made reference to the importance of expanding local vaccine production, and called on vaccine manufacturers and countries to expand “global and regional rpoduction of MRNA, viral vecdtor and/or protein subunit COVID-19 vaccines for low and lower-middle income countries.” But that, still falls short, some civil society groups said in the Summit aftermath.

Human Rights Watch was openly critical, saying: “by focusing more on redistributing existing supplies rather than on how to swiftly enable factories around the world to make more desperately needed Covid-19 vaccine and related products, governments at the summit missed an opportunity to take transformative action urgently needed to beat the pandemic and prepare for future threats.

“Dose sharing is helpful, but rich countries cannot donate their way out of this crisis as there simply aren’t enough shots to go around,” said Akshaya Kumar, crisis advocacy director at Human Rights Watch. “Without fixing the supply side of this problem, we’ll be stuck pushing this boulder up a hill only to watch it come crashing down once again.”

“Charity and good intensions will not end the COVID-19 pandemic,” declared the global health expert Madhukar Pai, director of McGill University’s Global Health Programs and McGill International TB Centre, in an op-ed in Forbes, on Thursday, a day after the summit’s conclusion.

“On the one hand, it was good to see President Biden show leadership in convening world leaders to galvanize action,” Pai noted, applauding Biden’s announcement of 1.1 billion in vaccine donations, including 500 million new doses. ” But on the other hand, he warned, the President’s calls upon high income countries to deliver on previous vaccine donation pledges may, or may not materialize.

“The problem with this charity-based approach is that rich nations have not delivered on what they already pledged. G7 countries have delivered only 14% of the total vaccine doses they had promised, according to the chief economist of the International Monetary Fund,” Pai noted.

Combatting vaccine hesitancy

On the demand side, meanwhile, The IAVG also called upon donors and countries to step up programmes addressing vaccine hesitancy, stating: 

“Several programmes have been put in place to increase confidence in confidence in COVID-19 vaccines and address vaccination hesitancy.   These must be tailored to local contexts and the engagement of local communities and civil society is critical to ensuring their effectiveness.”

It also noted that some regions and/or countries are experiencing civil unrest, conflicts and natural disasters that are impeding or slowing the implementation of vaccination programmes.  “Global solidarity and cooperation are needed to ensure they are supported in such critical situations.”

Image Credits: @TheWhiteHouse , @Airfinity/BBC , WHO, @vonderleyen , @CEPI .

Community Midwifery education in Bamiyan Province – services that brought support to women’s doorsteps are now at risk.

ISLAMABAD – Prior to the dwindling of foreign aid, a network of hundreds of Afghan midwives was delivering much-needed support to women at their doorsteps in the devastated nation that now faces breakdown.

Now, as Afghanistan grapples with the freeze of its assets in international institutions and shortages of foreign funds with the rise to power of the Taliban, the country’s innovative, but extremely fragile maternal health system faces grim threats of collapse – and with it, the innovative network of midwives.

“Some of our staff are no more showing up for duties mainly due to security concerns, particularly the female trainers and midwives, but others, including male doctors and administrative staff are seriously concerned about of lack of pay and long-term sustainability of the project,” said one official associated with this donor-driven project covering all four zones of the war-ravaged country. The official, interviewed by Health Policy Watch, asked to remain anonymous.

Like an array of public health projects peddled with the help of foreign support in aid-dependent Afghanistan, this unique venture, supported by a European NGO, has hundreds of Afghan male and female doctors, gynaecologists and midwives engaged in at least eight of the country’s 34 provinces.

The thrust of the project is to deliver aid and support to the neediest women in remote and rural areas of the country where access to healthcare facilities remains a challenge. It has engaged, trained and equipped midwives from within these communities for the sake of easy and free access for maternal health.

The World Bank funded Sehatmandi Project supports basic health, nutrition, and family planning services across Afghanistan. However, the programme is facing a dire shortage of funding and healthcare workers following the Taliban takeover.

No medicine, no salaries

The latest assessments by the World Health Organization (WHO) suggest almost two-thirds of clinics and hospitals in Afghanistan have stock-outs of essential medicines and most health workers in the public system have not been paid for months, while the brain drain of highly skilled healthcare workers due to insecurity is beginning to take its toll. 

In Afghanistan, a funding pause by international donors also threatens the continuity of the national ‘Sehatmandi’ programme – which had seen a 28% increase in people receiving essential health, nutrition and reproductive health servivces between 2017-2019.

Meaning “wellness”, the broad-based World Bank-supported initiative with the Afghan Ministry of Public Health, funds some 2,300 Afghan health facilities in 31 out of the country’s 34 provinces, and is a backbone of the national health system, says Dr. Ahmed Al-Mandhari, WHO Regional Director for the Eastern Mediterranean Region. He spoke at a press conference in Geneva on Thursday about the uncertain fate of that public health project and others heavily dependent on aid money.

“The health of women and children of this country will depend on the availability of female doctors, nurses and midwives. We call for a safe and productive work environment for female health workers, and for their ongoing education and training,” the WHO Representative to Afghanistan, Dr. Luo Dapeng told the same virtual press conference.

The concerns come amidst an evident surge in cases of measles and diarrhoea, as well as a resurgence of polio. Up to 50% of children, meanwhile, also are at risk of malnutrition. On top of all this, some 2.1 million doses of COVID-19 vaccine delivered to Afghanistan just prior to the Taliban’s takeover in August, remain unused, health authorities who requested anonymity told Health Policy Watch. 

The country has so far reported to WHO 154,800 cases of COVID-19 and 7,199 deaths.  But since the August takeover by the Taliban there have been significant interruptions to COVID-19 surveillance and testing – meaning that the sharp decline in new case reports seen since 3 August may be highly misleading.  Meanwhile, less than 3% of the population has been vaccinated with a full vaccine course, according to WHO.  

In one of the country’s poorest regions, Ghor province in the central highlands, the local health expert Muhammed Nazem told Health Policy Watch that more than 1,200 children stricken with measles have been referred to the province’s central hospital recently and 21 have died. “Due to the coronavirus and consequent restrictions, we were unable to implement the vaccination campaign against measles. So, for this reason, measles has spread throughout Afghanistan this year, especially in Ghor province,” he said.

Many national and global health experts now fear that the hard-earned gains seen over recent years, including a reduction in maternal and child mortality and moving towards polio eradication, are now at severe risk, with the country’s health system on the brink of collapse.

Engaging the Taliban

Upon concluding a trip to the war-ravaged country and meeting with Taliban leaders, WHO’s Director-General, Dr Tedros Adhanom Ghebreyesus told a press briefing in Geneva on Thursday that engaging with the new government is necessary to support the people of Afghanistan.

“The education of girls is essential for protecting and promoting population health, but also for building Afghanistan’s health workforce of the future,” said Tedros.

Dr Tedros Adhanom Ghebreyesus, WHO Director General, at a press briefing on Thursday.

For their part, Taliban leaders have promised to remove “impediments” to aid, to protect humanitarian workers, and to safeguard aid offices, according to a 15-point proposal addressed to the UN’s humanitarian aid coordination arm, OCHA, and signed by the Taliban’s acting minister of foreign affairs, Amir Khan Muttaqi.

The 10 September statement, which has been circulating among aid groups this week, also echoed previous pledges to commit to “all rights of women…in the light of religion and culture.”

However, with each passing day, the situation is becoming more and more grim, not only for Afghans in the remote and rural pockets, but also for people in towns and suburban centres where the prices of the medicine in the open market are rising to new heights as the country solely relies on imported medicine.

The president of Afghanistan’s pharmaceutical products trade association, Asad Uullah Kakar, told Health Policy Watch that prices of medicines have surged by 20% due to the closure of banks, disruptions in supplies, and freeze of funds leading to cash-crunch.

Within the communities themselves, health care workers are struggling to cope with the new situation – with noteworthy expressions of courage and determination among professionals determined to continue their routines and their jobs. 

As one senior midwife engaged in a donor-supported maternal and child care training and service project in eight provinces of Afghanistan, told Health Policy Watch, her commitment to saving lives remains strong:

“The whole village knows me and trust me, and I have been helping the women with their maternity issues just like my daughters and sisters. It would be good if these issues (lack of funds) are resolved, but I would never stop helping those I can help.”

Image Credits: Flickr – Canada in Afghanistan, World Bank, WHO.

In the coming months, 600 million doses of the Johnson & Johnson vaccines, manufactured in India, may be exported to Europe or the United States, at a time when India grapples with vaccinating its own citizens.

In the coming months, 600 million doses of single-shot Johnson & Johnson vaccines, manufactured in Hyderabad, are likely to be exported to Europe or the United States, at a time when India grapples with vaccinating its own citizens. Civil-society organisations are concerned that millions of doses of the COVID-19 vaccine may end up in the developed world, in regions with already high vaccination rates.

India recorded around 30,000 to 40,000 new COVID cases on most days in September. Only 14 percent of the population is fully inoculated against the virus. Prime Minister Narendra Modi’s government promised to fully vaccinate the nation’s adult population by the end of 2021, a target impossible to reach if India, under pressure from developed nations, exports most of the doses. Concerns regarding the destination of these vaccine doses are especially relevant ahead of the Quadrilateral Security Dialogue, or the QUAD—a summit of the leaders of the United States, India, Japan and Australia that is to be held in late September. Modi will be headed to Washington for the meeting, where vaccines are likely to be discussed.

India’s lifting of vaccine export ban welcome – but developing countries should benefit first

Moreover, on 20 September, Mansukh Mandaviya, Minister of Health, announced that India will resume exporting COVID-19 vaccines beginning next month —after shipments were halted in April due as the country was struck by a brutal second wave of the pandemic.  The Indian export ban hit hardest on Africa which was suppoed to receive hundreds of millions of doses of AstraZeneca vaccines, produced by the Serum Institute of India, through the WHO co-sponsored global COVAX vaccine facility.

“We welcome the lifting of restrictions but the vaccines have to go where there are needed most,” Leena Menghaney, the South-Asia Head for the access campaign by Médecins Sans Frontières, or Doctors Without Borders, said. “When India starts sharing vaccines with developing nations, the variants can be controlled. However, we need an account of supplies from J&J.” Menghaney mentioned an affidavit that the union government had submitted before the Supreme Court on 29 April that said that “a made in India J&J vaccine is expected to be available from August 2021.” Menghaney said, “We need an account [of] that.”

On 16 September, 14 India-based civil-society organisations wrote a letter to J&J, the government of India and the government of United States, protesting the pending arrangements.

Not the first time that J&J doses produced in low-income countries are earmarked for Europe or America

The letter also noted that this was not the first time.  “J&J has behaved negligently and callously in South Africa,” the civil society organizations stated, recalling how earlier this year, South Africa’s Aspen Pharmacare was contracted by J&J to produce 300 million doses of the J&J vaccine on a “fill and finish” basis – most of which were then shipped to Europe.

“At the moment, J&J has unfulfilled orders from the EU and the US among other rich countries, all of whom have been hoarding and ordering doses in excess of their domestic needs. There is undoubtedly much money to be made by fulfilling these contracts. But these countries are not where vaccines are most needed,” the letter also stated.

“As things stand, these vaccines will likely be exported to the European Union (EU) and the United States (US), where more than 50% of adults have been fully vaccinated, instead of going to India, which has only vaccinated 13% of its population to date, or to the African continent, where the equivalent figure is 3%.”

No clarification yet from Indian governmentor COVAX about where J&J doses may be headed

Neither J&J nor India’s government have yet clarified where the doses being produced in India are headed. The COVID-19 Vaccines Global Access, or COVAX, co-led by the global vaccine alliance Gavi, did not respond to specific queries about doses expected from India. COVAX is a worldwide initiative that aims to ensure equitable access to COVID-19 vaccines. In response to questions sent on 17 September, a GAVI spokesperson wrote, “In the face of ongoing Indian export restrictions, supply of doses from India continues to be blocked. Given the successful ramp-up of domestic production and the diminishing intensity of its own outbreak, we hope that India will ease its restrictions so that the world’s vaccine powerhouse can contribute to fighting the pandemic abroad as well as at home.”

Earlier this month, a report in the Washington Post noted that the pressure on India to resume exports of vaccines “comes as wealthy nations, including the United States, move to offer coronavirus booster shots to their own vaccinated residents.” On 15 September, Reuters reported that according to an anonymous Indian official, the country is considering resuming exports of vaccines, mainly to Africa. It quoted the official as saying, “The export decision is a done deal.” Yet, there is little clarity on how many doses will be exported out of India. As on 29 May, the Modi government had sold or donated nearly 66.4 million doses to other countries.

The Indian drug regulatory authority provided a rapid emergency-use authorisation to the J&J vaccine in August this year. J&J’s single-dose vaccine is being manufactured in India by Biological E, a Hyderabad-based company. The company’s managing director, Mahima Datla, told Nature, an international journal, that her company hopes to manufacture 40 million doses every month, though she does not know where they will go. “The decision on where they will be exported, and at what price, is under the purview of J&J completely,” she told Nature.

The letter by civil society organisations said that “J&J does not care about developing countries except when forced to.” In the case of the South African-produced J&J doses, for instance, only after there was a backlash from activists, did the European Union agree to send millions of coronavirus vaccine doses back to the continent. The continent has the lowest vaccine coverage in the world, with less than 3% of its population fully vaccinated.

African countries have fared the worst from global vaccine policies

African nations have thus been facing the worst end of global vaccine policies, in what is being termed “vaccine apartheid.”

Strive Masiyiwa, an official of the African Union, told the media in July of this year, “When we go to talk to their manufacturers, they tell us they’re completely maxed out meeting the needs of Europe, we’re referred to India.” He pointed out that the EU—while directing African nations to India—also imposed public-health restrictions on people vaccinated with Covishield, the India-produced version of the EU-accepted AstraZeneca vaccine. “So how do we get to the situation where they give money to COVAX, who go to India to purchase vaccines, and then they tell us those vaccines are not valid?” Masiyiwa said.

Several high-income countries have continued to block the TRIPS waiver, a proposal to temporarily drop the intellectual property rights on the COVID-19 vaccine and other therapeutics, at the World Trade Organization (WTO).

While hoarding vaccines, rich nations have also been opposing a proposal initiated by India and South Africa last October to waive obligations under the Trade-Related Aspects of Intellectual Property Rights, or TRIPS agreement, to make COVID-19 technologies, including vaccines, quickly accessible across the world. The countries cite quality concerns, among others, as the basis of their opposition, while outsourcing manufacturing to India and South Africa.

“The countries that are blocking the TRIPS waiver want it both ways,” Tahir Amin, an intellectual-property expert and co-founder of the non-profit Initiative for Medicines, Access & Knowledge (I-MAK), said. The countries opposing the waiver “are happy to exploit countries who support the TRIPS waiver proposal by having them produce vaccines for their own needs.” But, Amin said, these countries do not help those in support of the waiver “develop the capability or capacity to scale up more supplies to help themselves and others. The level of hypocrisy and ability to speak out of both sides of the mouth by the leaders of the EU, UK and Germany would be laughable if this were not such a serious situation.”

‘In the middle of a pandemic, J&J can choose who it most wants to send vaccines to, regardless of where they are most needed’

Achal Prabhala, the coordinator of the AccessIBSA Project—which campaigns for access to medicines and is one of the signatories of the 16 September letter—told me, “In the middle of a pandemic, I’m outraged that J&J thinks it can choose who it most wants to send vaccines to, regardless of where they are most needed.” Prabhala, who is also a fellow at the Shuttleworth Foundation, a South African philanthropic organisation, said that J&J’s calculations are likely to consider which country ordered vaccines first or offered the most money for them. “Our calculation—as we state in the letter—is simpler: who needs them most? That’s where they should go,” he said.

The letter by members of Indian civil society stated, “Vaccines are most needed in India and the African continent, and by the COVAX Facility, a global philanthropic initiative to get vaccines to the poorest countries in the world. Developing countries with large unvaccinated populations are witnessing a frightening rise in infections and deaths from COVID-19. J&J must prioritise them.”

“The fact that these doses are being produced with Indian labour, on Indian soil, gives us a say in where they go,” Prabhala said. “And we want them to go to India, the African Union, and the COVAX Facility—and nowhere else. Recent history suggests that J&J won’t set rational, humane, priorities unless we force them to—so we’re doing that.”

COVAX Supply forecasts say J&J delays in supplying global  vaccine facility

The COVAX supply forecast—overview of the supply of vaccines to COVAX—for September 2021 noted, “production issues at J&J’s Emergent facility (which is assigned to supply COVAX) have led to delays. While production has now restarted, the manufacturing ramp-up combined with the backlog of orders for other bilateral customers has led to delayed timelines and lower volumes that will be made available to COVAX in 2021.”  In April, the facility was forced to suspend operations and dump millions of doses of vaccines, due to contamination issues at the Baltimore, USA-based plant.

In their letter, Indian civil-society organisations urged US President Joe Biden to compel J&J to partner with drug companies in the global south, to move towards vaccine equity. “If US President Biden is indeed serious about vaccinating the world, his administration has the moral, legal, and if necessary, financial power to lift intellectual property barriers and persuade J&J to license its vaccine, with technology and assistance included, to every manufacturer currently engaged in making the Sputnik-V [Russian] vaccine,” the letter stated.

The policies in India, often called the pharmacy of the developing world, will be central to taming the pandemic in low- and lower-middle-income countries. Rajesh Bhushan, the health secretary, and Paul Stoffels, the vice chairman of the executive committee at J&J, did not respond to queries asking for a breakup of the J&J doses that will be given to India.

Republished, with permission from the India-based journal Caravan.

Vidya Krishnan is a global health reporter and a Nieman Fellow. Her first book “Phantom Plague: How Tuberculosis Shaped History” will be published in February 2022 by Public Affairs.

Image Credits: Flickr – New York National Guard, Flickr – New York National Guard, Shutterstock.

US regulatory agencies established the populations eligible for the Pfizer/BioNTech booster shot this week, paving the way for the rollout of boosters nationwide.

The Director of the US Centers for Disease Control and Prevention (CDC), Dr Rochelle Walensky, has authorized millions of frontline workers in health care and school settings to receive a third COVD-19 vaccine booster dose-  opening the gates for a much wider wide swathe of Americans, ages 18-64, to receive the controversial booster shots. 

Her ruling late Thursday overruled that of a CDC’s Advisory Committee on Immunization Practices, which had endorsed Pfizer/BioNTech booster shots only for millions of older individuals and others at high risk of contracting the disease after a meeting on Thursday.

However, the panel voted against allowing frontline workers aged 18 to 64 years from getting another jab. This had put the recommendations at odds with the Food and Drug Administration’s (FDA) decision to authorize Pfizer booster shots for workers at risk, on Wednesday. 

The FDA authorized the use of boosters at least six months after the completion of the primary vaccination series in individuals over the age of 65; those aged 18 to 64 at a high risk of severe COVID-19; and those aged 18 to 64 whose occupation puts them at a high risk of serious complications of COVID-19.

Walensky’s decision to include adults working in high-risk settings, such as health care and school systems, aligned the CDC’s policy with the FDA. 

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Walensky said at a meeting on Thursday. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

Dr Rochelle Walensky, Director of the US Centers for Disease Control and Prevention (CDC).

She said that providing boosters to healthcare workers would “best serve the nation’s public health needs.”

Walensky’s decision will cover healthcare workers, teachers, and people living or working in institutional settings, such as prisons or homeless shelters. 

The panel attempted to limit those eligible for boosters, refusing to open jabs to healthy adults who aren’t at risk of severe illness. Members of the advisory committee wanted to avoid an all-adult booster campaign. 

Walensky’s decision was announced late on Thursday, demonstrating the complex decision making around the issue of boosters. 

The recommendations from the CDC and FDA still represent a considerable scale back on US President Joe Biden’s far reaching booster plan, which was designed to rollout the week of September 20. 

Some 20 million people are now eligible for a booster and in the coming months 40 million more people will become eligible, said Biden at a White House press briefing on Friday. 

Only Americans who already received two doses of the Pfizer/BioNTech vaccine will qualify for booster shots.  FDA authorization of boosters for Moderna or Johnson & Johnson vaccines and the safety of allowing mixing-and-matching with boosters, has yet to be addressed. 

‘Pandemic of the unvaccinated’ needs to be urgently addressed

Despite the current focus on boosters, the priority of vaccinations should be on getting the unvaccinated their first shots, which is the leading cause of rising COVID cases and hospitalizations, American experts have stated, echoing the position of the World Health Organization and many other global health officials.

“We can give boosters to people, but that’s not really the answer to this pandemic,” Dr. Helen Keipp Talbot, Professor of Medicine at Vanderbilt University, told NPR. “Hospitals are full because people are not vaccinated. We are declining care to people who deserve care because we are full of unvaccinated COVID-positive patients.”

According to Walensky, the top goal “here in America and around the world” is to vaccinate the unvaccinated. 

Over 70 million have yet to get a single shot, said Biden. 

US President Joe Biden at a press conference on the COVID-19 Response and the Vaccination Program on Friday.

“Listen to the voices of the unvaccinated Americans who are lying in hospital beds, taking their final breaths, saying…’If only I got vaccinated,'” Biden said. “People are dying and will die who don’t have to die.” 

Biden urged people to get vaccinated and announced his commitment to implement vaccination requirements wherever possible. Currently the vaccination mandates cover two thirds of all workers in the US. 

“We made so much progress during the past eight months of this pandemic, now we face a critical moment,” said Biden. “We have the tools, we have the plan, we just have to finish the job together as one nation. And I know we can…Please look out for your own self interest and health here. Get vaccinated.”

Image Credits: Flickr – Province of British Columbia, International Monetary Fund/Ernesto Benavides, Centers for Disease Control and Prevention, White House.

regen-cov
Riviera Beach Fire Rescue starts REGEN-COV Infusion treatments within the city of Riviera Beach, Florida.

REGEN-COV, the antibody cocktail made famous by Donald Trump when he became ill with COVID in 2020,  was added Friday to WHO’s list of recommended drug treatments in updated COVID-19 clinical management guidelines, published Friday. 

At the same time, WHO and Médecins Sans Frontières/Doctors Without Borders (MSF) called on the US pharma firm Regeneron, which developed the cutting-edge drug treatment, to reduce the high prices for the drug and expand now-limited production of the medicine. 

“WHO calls on Regeneron to lower prices and distribute it equitably across all regions, especially in LMICs,” the WHO statement said, adding that Regeneron should also “transfer the technology” so that similar versions of the treatment may be created and easily accessed in lower-income settings. 

“It is simply not fair that people living in low- and middle-income countries cannot access new COVID-19 treatments that can decrease the risk of death because of pharmaceutical companies’ monopolies and wishes for high returns,” said Dr Elin Hoffmann Dahl, Infectious Disease Advisor for the MSF Access Campaign, in another statement from MSF.

He also noted that the pharma company had benefited from significant public funding to develop the cocktail in the first place, with the US signing a US $450 million contract with Regeneron last year.  

Regeneron has ignored pressures by access groups to lower prices and widen access to cocktail

Regeneron has so far ignored pressures by access groups for such concessions. 

It has priced the antiviral cocktail at US $820 in India, US $2,000 in Germany and US $2,100 in the US.  The company also has filed patent applications in at least 11 more low- and middle-income countries (LMICs) – clearly demonstrating its intent to protect markets there against less expensive, biosimilar alternatives.  

The drug is the first to be recommended by WHO for use in patients with non-severe COVID-19, but  at high risk of more severe disease progression.  It’s also being recommended for people with severe infection, but lacking sufficient antibodies of their own. 

The antibody cocktail includes two monoclonal antibodies (mAbs), casirivimad/imdevimab, shown to have decreased the risks of hospitalization for non-severe COVID-19 patients with high risk of developing severe disease.  The drug has also been shown to  decrease the risk of death for COVID-19 patients already in severe condition, with their own antibody deficiencies.  

It was authorized for emergency use by the US  Food and Drug Administration in November, and is now part of the “handful of authorised COVID-19 treatments [that] are becoming standard of care for COVID-19 patients,” according to International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Director General Thomas Cueni, in a media briefing early September.

“Monoclonal antibody treatments are beginning to offer promise as are novel antivirals,” said Cueni.

MSF: ‘Price Should Reflect Cost of Production’

REGEN-COV is part of a drug class of monoclonal antibodies, or mAbs.

The US has recently purchased an additional 1.4 million doses of REGEN-COV, to be provided at no cost to patients.

Large scale production of monoclonal antibodies (the drug class casirivimab and imdevimab belong to) is estimated to be below $100/per gram, says the MSF statement. 

One dose of REGEN-COV is 1,200 mg, purchased from the US government at US $2,100 per dose. This price is 17 times the value of large-scale production of mAbs. 

Accordingly,  Regeneron should “drop the price to reflect the cost of production”,  MSF said. 

“Regeneron should instead set an example for all manufacturers of monoclonal antibodies by putting people’s lives before profits, immediately lower the price, stop pursuing monopolies and share the know-how and technology to produce casirivimab and imdevimab with manufacturers in low- and middle-income countries.” 

Scarcity of COVID-19 treatment ‘Unacceptable’

Monoclonal antibodies have long been used to treat other diseases, including cancers. There have been long standing problems with high prices and supply shortages for older mAbs used in other treatments as well, said former MSF Emergency Field Coordinator Joan Tubau, who described the situation as “unacceptable.” 

In light of that history, MSF’s concerns about REGEN-COV are particularly acute, he emphasized. 

“Access to new COVID-19 treatments must be ensured, especially in places where vaccine coverage is low and recurrent waves are inevitable, to prevent even more inequity in this deadly pandemic,” said Tubau.

That’s particularly true in light of the history of high-income countries monopolizing COVID-19 vaccines, he said.  

“And yet, we’re seeing the same governments that bought up and stockpiled COVID-19 vaccines make similar advance purchases of COVID-19 treatments, leaving little supply for the rest of the world unless Regeneron allows other companies to help boost the global supply.”

Additionally, REGEN-COV could play a particularly lifesaving role in countries with low vaccination rates.  And yet, paradoxically, those same countries may be the last to be able to access the lifesaving antibody cocktails, she warned, thanks to the market dynamics of pharma sales.  

“In many countries where MSF works in Latin America and Africa, scarce access to hospital beds, insufficient numbers of health care workers to deal with the surge of patients, and lack of medical oxygen makes prevention of hospitalisation vital – an antiviral cocktail like casirivimab/imdevimab could be essential.” 

Image Credits: Riviera Beach Fire Rescue/Twitter, NHS Research Scotland/Twitter.