Loyce Pace, Assistant Secretary for Global Affairs at US Health and Human Services

Despite earlier disruption from Ethiopia, Dr Tedros Adhanom Ghebreyesus received overwhelming support for his nomination for a second term as World Health Organization (WHO) Director-General from the body’s executive board on Tuesday.

As the only nominee, Tedros is guaranteed to be re-elected at the next World Health Assembly in May.

All WHO regions expressed their support for is nomination, including the African region which commended the global body for its clear nomination process – the message delivered by a representative from Burkino Faso, a country in limbo since a military coup on Sunday night.

 

As part of the nomination process, Tedros gave an address to the board and answered a number of questions.

During his address, he appealed for “assessed member state contributions” to cover at least half of the WHO’s roughly $3.5 billion a year budget. At present, assessed contributions (fees based on countries’ GDP) account for less than 20% of the budget, with the remainder from voluntary contributions which are usually earmarked for particular issues, preventing flexibility and equitable regional distribution, said Tedros.

WHO funding 2021

Financing dominated the second day of the board meeting, with Germany’s Bjorn Kummel, chair of the Working Group on Sustainable Financing (WGSF) describing the global body’s finances as “rotten and unsustainable for the future”.

In the run-up to the board meeting, Kummel’s group had failed to reach consensus on the proposal that at least half of the WHO’s budget should come from assessed contributions. The board agreed on Tuesday to extend the group’s mandate until May in the hope that a contribution formula can be agreed on.

The US and Japan are holdouts on increased member contributions unless the WHO guarantees to improve its financial governance.

During afternoon proceedings, US representative Loyce Pace called for a “holistic package of measures” to ensure WHO sustainable finance, that included improved governance and transparency on “current funding mechanisms, prioritisation, budget processes, improved cost efficiency and early member state inclusion in the decision-making processes”.

When Japan asked Tedros how he was going to reform WHO’s financing, particularly  “accountability and transparency and financial discipline”, he asked for the country’s support to increase members assessed contributions.

He explained that under his leadership voluntary contributions had risen from around $14m in 2017 to almost $260m – but no progress had been made on increasing assessed contributions.

However, Tedros later assured members that he was committed to increased accountability and transparency, and would deliver this.

Bjorn Kummel, chair of the Working Group on Sustainable Financing.

Transformation plan – where has it led? 

Shortly after taking office, Tedros undertook a massive transformation plan for WHO, aimed at making the organization more transparent and responsive to the needs of member states, and with more “leadership” in developing regions and countries. 

However, COVID-19 forced the WHO to shift focus from internal reforms to responding to an immediate crisis, while a temporary halt in US funding under former US President Donald Trump sparked a short-term financial crisis. 

A key element in the transformation plan, to move more funding and positions to WHO’s six regional and 152 country offices was stymied by the COVID-19 crisis. 

The pandemic also cut short a new WHO system of more regular rotations of staff in and out of headquarters to regions – along the lines of diplomatic missions – to which there was already considerable staff opposition pre-pandemic.

As a result, WHO is falling short of what has been a decades-long target for a 75%-25% split of its budget between regions and headquarters with over 30% of the total budget being spent in headquarters today.

This goal was surpassed in 2016/7, the last budget cycle before Tedros took office, when 84% of the budget was spent in regions, and only 16% at headquarters.  

The net result is the persistent under-financing of African and South-East Asian regions – which generally host the biggest disease burdens in the world. The African Region only gets 22% of WHO funding – although that is supplemented by direct bilateral support from the US and other donors through channels like PEPFAR – the US HIV/AIDS relief plan which has been a backbone of HIV/AIDs battle since 2003 – funnelling some $10.8 billion into AIDS programmes – and hybrid AIDS/COVID efforts in 2021. 

The Western Pacific (including China, Pacific Island States, Australia and Japan) receives only 4.28% of funding. The South-East Asia Region only gets 6% – about the same as the European Region – whose budget is also self-financed by EU member state contributions. In contrast, the conflict-wracked Eastern Mediterranean gets 26% of the WHO programme budget. 

The Americas region gets the least, less than 3% – although WHO support is is massively supplement by the US and other North American donors that fund the powerful Pan American Health Agency (PAHO), as a semi-autonomous agency.  

Not without reason, however, responding to health emergencies has also consumed a huge portion of WHO’s recent budget – some 41 % of resources in 2021.

UN Foundation Vice President of Global Health, Kate Dodson, sent a letter to the Board on behalf of a wide group of health organisations appealing for increased funding, which was read out on Tuesday 

The letter calls for member states to “agree to increase the share of assessed contributions to the WHO base budget to 50% by 2029”, noting that only a “sustainably financed WHO that is not subject to the political influence of its donors or the whims of funding flows can fulfill its role as the leading technical and normative international body”.

Over-dependence on short-term consultants 

Meanwhile, as things stand now, WHO insiders say that the body is overly dependent on short-term consultants that it parachutes into jobs. Approximately a quarter of WHO staff are on short-term contracts, according to insiders. 

The net result is an organisation that lacks a stable backbone of fixed-term professional staff – from entry to senior levels –  that can dare to question conventional wisdom and take unpopular positions in a large bureaucracy. 

That, along with a weak internal justice system, which was the focus of WHO Staff Association complaints at last May’s World Health Assembly, have reinforced what some WHO insiders describe as “authoritarian” tendencies in the DG’s office and Tedros’ leadership style. This, in turn, also diminishes the independent authority of his Assistant Director Generals – who are anyway all politically appointed. See Related Story: 

WHO Internal Justice Needs Reforms; Staff On “Unequal Footing” With Administration  

Ethiopia’s Permanent Representative to the UN in Geneva, Zenebe Kedebe

Ethiopia may try to disrupt Tuesday morning’s closed session of the World Health Organization’s (WHO) Executive Board meeting where the nomination of the next Director-General will happen via secret ballot.

Incumbent Dr Tedros Adhanom Ghebreyesus is the only nominee, but Ethiopia – which nominated him four years ago – has taken exception to their former health and foreign minister’s criticism of its handling of the Tigray people. 

Ethiopia’s Permanent Representative to the UN in Geneva, Zenebe Kedebe, used Monday’s opening of the board to attack his country’s famous citizen and the first African Director-General, saying that Tedros had “failed to live up to expectations”.

Despite being twice ruled out of order by the board chairperson, Kenya’s Dr Patrick Amoth, Kedebe persisted in trying to read his statement, saying that it was his “sovereign right” to make a statement.

Ethiopia had earlier sent a diplomatic note (called a note verbale) to the board complaining about Tedros, which it has alleged is abusing his position for political gain. 

However, board members had ruled before the meeting that the note would not be discussed, with Amoth noting at the start of the meeting that the note contained complicated legal and political issues.

Relations between Tedros – who has been nominated for re-election by Germany and France – and his home country have deteriorated over the Ethiopian government’s blockage of humanitarian aid to the Tigray region. 

“Imagine a complete blockade of seven million people for more than a year and there is no food, no medication, no medicine, no electricity and no telecommunication. No media, nobody can report and when there is no telephone, I think accessing families is difficult. No cash, no bank service. Imagine the impact of all of these,” said Tedros, who is from Tigray, at a recent media briefing.

The WHO has been unable to deliver life-saving medications for nearly six months – a situation it has described as “unprecedented” even in comparison to Syria or Yemen. 

During the afternoon board meeting, Ethiopia’s Health Minister Lia Tadesse thanked member states and the WHO for its effort against the pandemic, but scrupulously avoided mentioning Tedros.

Secret ballot

According to the nomination process, executive board members will vote via secret ballot for their candidate of choice – even although there is only one nominee.

“Board members’ delegations wishing to participate in the decision on the nomination of the candidate for the post of Director-General must be physically present at WHO headquarters in Geneva,” according to a board circular.

“This decision will be taken through a secret ballot vote on the basis of a yes or no vote. The majority required for the proposed candidate to be nominated is a simple majority of those present and voting.”

The nomination will be taken to the next World Health Assembly.

Ethiopia, which is one of the most powerful countries in Africa, has close ties with China. However, it remains to be seen whether it will be able to persuade other countries to vote against Tedros, the most public face of the global response to COVID-19.

 

Dr Cleopa Mailu, Kenya’s Ambassador to the UN in Geneva and a former health minister, speaking at the WHO Executive Board meeting on Monday

Unless a future pandemic ‘instrument’ is properly financed and legally binding, it will not be able to prevent health emergencies, numerous member states told the World Health Organization’s (WHO) 150th executive board meeting on Monday.

Speaking on behalf of Africa’s 47 member states, Kenya’s Dr Cleopa Mailu said there should be a “radical disruption” of the WHO’s programme budget, calling on the board to “take bold steps” to adopt recommendations that will improve the WHO’s financing place it “on a more stable footing as the lead UN agency for coordinating global health”.

The WHO secretariat has requested an increase of $480 million for the emergency programme alone, he noted.

Speaking on behalf of the European Union, France agreed that sustainable financing needs to be at the heart of strengthening the WHO. 

“We cannot ignore the chronic underfunding of the organisation, something that hampers its ability to step up to member state expectations,” said France’s Professor Jerome Salomon.

France also called for the WHO to operate with “increased efficiency through streamlined governance, accountability, and an executive board that is committed to increasing transparency and swift decision making”. 

Even Japan, which has been resistant to an increase in member states’ contributions to the WHO, stated its commitment to “strengthening sustainable financing of WHO”.

However, Japan also called for a “simultaneous in-depth conversation between member states and WHO to further strengthen its financial discipline and transparency”.

Limited changes to International Health Regulations 

In the past, some countries and civil society organisations have stressed that it would be more effective to strengthen the International Health Regulations (IHR) rather than creating a new structure.

Russia appears to favour this approach, asserting that the IHR – the only global legally binding rules that govern countries’ responses to health emergencies – “must remain the cornerstone of preparedness and response to health emergencies”.

However, the EU believes that stronger IHR will complement a new pandemic instrument. It is supporting a US-sponsored  resolution to the board that calls for limited amendments to the IHR to address “specific and clearly identified issues, challenges, including equity, technological or other developments, or gaps that could not effectively be addressed otherwise but are critical to supporting effective implementation and compliance of the IHR”.

Meanwhile, Germany welcomed the proposal from the WHO Secretariat for a Universal Periodic Review mechanism to monitor IHR implementation and compliance, describing it as a “potential game-changer”.

Negotiating a pandemic ‘instrument’

Austria’s Dr Clemens Martin Auer

Negotiating such an international pandemic response instrument would not be easy or quick, but it was urgent and “indispensable”, Austria’s Dr Clemens Martin Auer told the board.

Austria stressed that this instrument – also called a pandemic treaty – should be “legally binding to have full impact”, and have ”strong mechanisms” to share information and technology, especially vaccines. 

But Auer stressed that, in creating such “a new global architecture, we should avoid any motion of further fragmenting the responsibilities and competencies.” 

“When it comes to deal with matters of health emergency, we don’t need additional structures, especially when we would lose inclusivity for all member states and transparency,” said Auer.

Late last year, a special session of the World Health Assembly resolved to set up an inter-governmental negotiating board (INB) to take forward these negotiations.

France’s Salomon, speaking for the EU,  said that a pandemic treaty would provide member states with a “a common roof” to organise multi-sectoral pandemic preparedness and response.

France added that the Dutch Director of International Affairs in the Ministry of Foreign Affairs would lead European negotiations at the INB. 

“The EU and its member states look forward to the establishment of the INB, and to its first meeting in February, and for the working draft to be developed and submitted before the second meeting this [European] summer,” said Salomon.

The US and Germany both supported the inclusion of civil society in pandemic instrument negotiations – something that is opposed by Russia and China.

WHO Director General Dr Tedros Adhanom Ghebreyesus addresses the opening of the 150th session of the WHO Executive Board Monday, 24 January

Even though the end is not yet in sight for the COVID pandemic, the world can end it as a global health emergency in 2022, says WHO DG at the opening of the 150th sesssion of the World Health Organization Executive Board.

While the world will be living with COVID for the foreseeable future, countries can end the acute phase of the pandemic this year, said WHO’s Director General Dr Tedros Adhanom Ghebreyesus Addressing the opening session of a week-long WHO Executive Board meeting in Geneva, the DG warned that the world will need to learn to manage the virus through a sustained and integrated approach to acute respiratory diseases –  which will also provide a platform for preparing for future pandemics.

“Learning to live with COVID cannot mean that we give this virus a free ride. It cannot mean that we accept almost 50,000 deaths a week from a preventable and treatable disease. It cannot mean that we accept an unacceptable burden on our health systems when everyday, exhausted health workers go once again to the frontline. It cannot mean that we ignore the consequences of long COVID which we don’t yet fully understand. It cannot mean that we gamble on a virus whose evolution we cannot control nor predict,” Tedros said.

He added that it is dangerous to assume that Omicron will be the last variant or that the world is in the end game for the pandemic while on the contrary, globally, the conditions are ideal for more variants to emerge.

And he appealed to WHO member states to agree on a fromulat to increase their regular, fixed payments to WHO according to a proposed 5-year scale-up plan, that would give the Agency a greater ability to plan and budget rationally, warning that, if the current funding model, dependent on voluntary contributions continues “WHO is being set up to fail.  A paradigm shift in world health that’s needed must be matched by a paradigm shift in funding.”

Germany now WHO’s largest donor – says US$ 20 billion needed for vaccines, tests and treatments in low-income countries

Svenja Schulze, German Minister for Economic Cooperation & Development

The WHO Director General spoke shortly after holding a joint press conference with Germany’s new Economic Cooperation and Development Minister, Svenja Schulze, where he told reporters that Germany was now WHO’s largest donor.

“As you all know, Germany has been an important friend and longstanding partner to WHO and in fact it is now WHO’s largest donor,” said Tedros Adhanom , speaking alongside Schulze who assumed her post in Germany’s new government elected late last year.

Traditionally the United States has been WHO’s largest financial backer, contributing about US$250 million a year in “voluntary contributions” alongside about about $115 million in regular “assessed contributions” – the paid by virtually all 194 member states, according to a fixed and scaled formula.  But that was outpaced by Germany, which was contributing to the tune of about $560 million a year as of the third quarter of 2021 – most of it in voluntary contrbutions.

But Germany has emerged as one of the strongest political backers of WHO over the course of the pandemic.  Last year, Germany opened a WHO Hub for Pandemic and Epidemic Intelligence in Berlin – to step up surveillance.

And it is also leading the charge for a deeper change in the Organization’s financing formulas. According to that proposal, fixed, “assessed contributions”  by WHO member states would gradually rise to 50% of WHO’s US$ 3.5 bilion-a-year budget to ensure more predicatable funding.  Germany, along with European and other African states have been pushing hard for a clear signal on the measure at this week’s EB, but that is unlikely in light of the continued resistance from several other rich and middle-income countries, including Japan, the United States, Argentina and Brazil. See related story here.

As WHO Executive Board Meets – Handful of Countries Stall Plans to Reform WHO Finance

In the pre-EB press conference, Schulze also said she’d use Germany’s new G-7 leadership role to ensure sufficient pandemic response funding was available to low-income countries in 2022 – noting that some US$ 20 billion would be needed from donors.

“We know that around $20 billion will be needed this year to supply the poorer countries with vaccines, tests, and therapeutics. The G7 will play an important role in that organization for the world. We will be pushing for the world’s bigger economies to contribute their fair share of that financing,” she said, adding that the world needs a “massively accelerated truly global vaccination campaign – along with stronger health systems overall.

But she admitted that Germany remains opposed to a proposed World Trade Organization waiver on COVID-related intellectual property, contending that voluntary licensing of available know-how is a better way to jump start more manufacturing efforts in low- and middle-income regions.

“We are convinced that patent protection encourages innovation; it led to the development of these vaccines,” she said, adding that the world, “will need further innovations in order to deal with the further variants of COVID, but also the many other diseases that we have in the world, where we will need vaccines.” 

Dangerous to assume Omicron will be the last variant or the end game

Executive Board 150 – The 34 members of WHO’s governing body and obserers meet in Geneva in a hybrid session.

Speaking later at the EB Opening, Tedros warned that while “there are different scenarios for how the pandemic could play out…. it’s dangerous to assume Omicron will be last variant or we are in the end game. On the contrary, globally conditions are ideal for more variants to emerge.

“To change the course of the pandemic, we must change the conditions that are driving it. We recognize that everyone is tired of this pandemic,” he added.

But even if the virus becomes endemic, the world can end the pandemic in 2022 – and reduce the risks of new variants emerging with more universal COVID vaccine coverage, and the deployment of other public health measures. 

“If countries use all of these strategies and tools in a comprehensive way, we can end the acute phase of the pandemic this year,” Tedros said.

“We can end COVID-19 As a global health emergency, and we can do it this year.” 

He restated the aim of vaccinating 70% of the eligible population of every country by mid-2022 – with a focus on the most at risk groups.  COVID mortality can be reduced by enshrining strong clinical management beginning with primary health care, and equitable access to diagnostics oxygen and new oral antiviral drugs at the point of care. 

Other essential elements include the need to further increase COVID testing and genetic sequencing of virus samples globally to track the virus closely – and monitor the emergence of new variants.  Identification of new variants early on will improve countries’ ability to calibrate the use of public health and social measures when needed – as happened in South Africa with the early identification of Omicron. 

But as the world enters what is now the third year of the pandemic, a renewed focus also needs to be placed on other long-neglected health services, he emphasized.

“It [also] means restoring and sustaining essential health services. And it means learning critical lessons and defining new solutions now, not waiting until the pandemic is over. We can only do these with engaged and empowered communities,” the WHO DG said.  

Progress despite COVID

An infant receiving the RTS,S malaria vaccine in Ghana in 2019. New malaria vaccines, which hold promise of significantly reducing childhood infections and severe malaria, are now being rolled out more widely in Africa.

Despite the strains on global health as a result of COVID-19, the WHO DG noted that several giant strides were still recorded on several health issues in different parts of the world.

 WHO issued a historic recommendation for widespread use of the world’s first malaria vaccine, which Tedros said could save tens of thousands of young lives each year. 

“China and El Salvador were certified by WHO as malaria free last year, and the Islamic Republic of Iran recorded three consecutive years of zero in cases of malaria,” he added, noting the continued progress against elimination of what remains the world’s most deadly parasitic disease. 

He added that eight countries achieved “90-90-90” percent targets for testing, treatment access and viral suppression of HIV by the end of 2020, while a further 20 countries are close. 

Moreover, a total of 15 countries have eliminated mother-to-child transmission of HIV and/or syphilis with Botswana in 2021 becoming the first high burden country in Africa to achieve Silverchair certification on the path to elimination of mother to child transmission of HIV.

Progress was also recorded in the global fight against hepatitis, neglected tropical diseases and eradication of wild polio, he pointed out.

Health is not a byproduct of development

The WHO DG noted that the COVID-19 pandemic has shown the world that health is not merely a byproduct of development nor an outcome of prosperous societies — or a footnote of history.

“It’s the heartbeat, the foundation, the essential ingredient without which no society can flourish,” the DG said.

Considering health is dependent upon the fullest cooperation of individuals and the states, WHO DG warned that the continuing inequitable pace of development in different countries, with respect to the promotion of health and control of disease, remains a common danger for everyone.

Beyond that, he underlined that reaching “the highest attainable standard of health is one of the fundamental human rights of every human being” – echoing the vision set out in the original WHO Constitution.

Rising Tensions with Ethiopia

The DG’s speech received a positive receiption from most WHO member states – but with the notable exception of Ethiopia.

Ethiopia’s EB representative took the floor in an attack on Tedros’ his statements about the health and humanitarian situation in the countriy’s blockaded Tigray region, saying that the WHO DG was “using his office to adance his personal political interests.”

But he was cut off by EB Board Chair Patrick Amoth of Kenya who said that he was out of order since the EB had decided to set aside a  “note verbale” on the allegations, which had earlier been submitted by Ethiopia to the board. Amoth declined to disclose the full contents of the note verbale, saying it was “complicated” and fraught with legal and political implications.  

There has been a rising chorus of Ethiopian government media and social media mudslinging against Tedros and other UN groups, recent accusations against the DG of misconduct.

That comes as WHO and DG Tedros protested the Ethiopian government’s months-long blockade of the rebel Tigray region – asking officials to permit entry to humanitarian aid for medicines and other basics like insulin.  In a recent press briefing, the DG noted that the current ban on the entry of international relief workers is unprecedented even in the annals of the world’s most bitter civil conflicts.

WHO Slams Ethiopia’s ‘Blockade’ on Health Relief to Tigray Region as ‘Catastrophic’ and ‘Unprecedented’ Even in Conflict Zones

The WHO stance and DG’s comments have been widely echoed by other UN and humanitarian groups, confirming the dire situation that has left hundreds of thousands of people on the verge of starvation, as well as unable to acces medical care. But the fact Tedros is Tigrayan, as well as the sole WHO candidate running for re-election to head the agency, have left him open to personal political attack, observers say.

European Union officials recently charged that the Ethiopian state-controlled media also have been circulating “Fake News” about European humanitarian aid efforts and the WHO.

At the EB in Geneva, Kenya’s Ambassador to the UN in Geneva, speaking on behalf of WHO’s African group, also gave Dr Tedros tacit backing, saying that WHO should remain focused on it’s main health mission.

“The African member states wish to underscore the importance of WHO maintaining focus on the needs of those most vulnerable through providing the required support to member states at the country level in pursuit of their national, global commitments and the SDGs,” said Dr Cleopa Mailu, who is also a former Kenyan Health Minister.

Dr Cleopa Mailu, Kenya, speaking at the WHO Executive Board meeting on Monday

–Elaine Fletcher Ruth contributed to this story. 

Image Credits: WHO.

Israeli couple receives fourth dose of COVID vaccine in Israel
Israeli couple receives fourth dose of COVID vaccine in Israel

In still evolving data, yet another Israeli study has found that health workers who received a fourth dose of a Pfizer mRNA vaccine were half as likely to contract Omicron seven days after receiving the shot in comparison to people who only got three doses.  The study released Thursday came less than one week after another major hospital research center cast doubt on the effectiveness of the extra jab after providing it to several hundred health workers in a controlled clinical trial.

The evolving data reflects some of the ongoing debate among experts the world over over the effectiveness of additional doses of the same vaccine against the current variant wave – something few countries and hospitals have tested so far outside of Israel.

Tel Aviv Sourasky Medical Center released data from its real-world study of 6,863 medical workers who were vaccinated with a third dose of the Pfizer coronavirus vaccine between August and December 2021 and had not previously been infected with corona, including 1,316 workers who received the fourth dose as of January 3, 2022. During this period, 608 workers tested positive – but only 42 of them were diagnosed with the virus seven days or more after receiving the fourth vaccine.

From the analysis of the data using a regression model, the hospital concluded that “the risk of contracting the virus is twice as low seven days after receiving the fourth dose.”

Tel Aviv Sourasky Medical Center reveals real-world results of fourth dose campaign
Tel Aviv Sourasky Medical Center reveals real-world results of fourth dose campaign, showing that medical workers who took the shot were half as likely to contract COVID after seven days.

However, Sourasky added in a press release, these results “must be interpreted with caution” due to the short follow-up period of just 15 days after innoculation.

Other trial tested both Pfizer & Moderna

Sourasky’s report comes only days after Sheba Medical Center at Tel Hashomer shared preliminary results of its Helsinki-approved fourth shot clinical trial, indicating that a fourth dose of Pfizer or Moderna does not provide enough of a boost to significantly protect against Omicron.

Prof Gili Regev-Yochay, who is leading Sheba’s research on the matter, told reporters on Monday that two weeks after receiving a fourth Pfizer vaccine and one week after receiving a fourth Moderna jab that “the increase in antibodies is nice” but not enough to stop infection.

Some 154 medical workers from Sheba are participating in a trial of the a fourth Pfizer vaccine and another 120 in the Moderna arm of the experiment.

Although Regev-Yochay would not share numbers, she said that only slightly fewer people who received the fourth dose caught coronavirus than those in a control group, who were fully vaccinated with two shots and a booster.

Majority of seriously ill or hospitalized people continue to be those who are unvaccinated at all

In all cases, the researchers have stressed that while Omicron might break through the vaccines more than previous strains, the vaccines continue to stop severe disease. Regev-Yochay said that none of the study participants who got Omicron developed a severe or life-threatening case and the majority of serious patients in Israeli hospitals continue to be unvaccinated or people vaccinated with only two shots more than six months ago.

Israel’s Health Ministry approved giving a fourth shot for immunocompromised people in late December and soon after expanded its decision to include people over the age of 60 and medical workers. So far, more than half-a-million citizens have taken the fourth dose.

A handful of other countries have also approved offering its citizens fourth doses, including Greece, Chile and Brazil, though no other countries have started full campaigns nor released research on the effectiveness of the protocol.

The World Health Organization has spoken out against fourth shots, saying earlier this month that “a vaccination strategy based on repeated booster doses of the original vaccine composition is “unlikely to be appropriate or sustainable.”

But WHO’s Chief Scientist Dr Soumya Swaminathan also has said that more studies are needed to understand the duration of protection in different population groups after vaccines and boosters.  And, rather than pursuing boosters or vaccines for each new variant, she has called for R&D into vaccines that can hit at all “beta-coronaviruses”.

And rather than develop more variant-specific vaccines, Swaminathan and other leading vaccine experts, such as Peter Hotez of Texas Children’s Hospital have said work should be focused on more broadly neutralizing beta coronavirus vaccine – hitting not only at SARS-CoV2 but other SARS or SARS-like viruses that are circulating in the wild and likely to emerge at a later date.

https://twitter.com/PeterHotez/status/1460596460026748938

Image Credits: Maccabi Health Services, Tel Aviv Sourasky Medical Center.

Novak Djokovic holding the 2019 Wimbledon men’s trophy – his departure from Australia was not as glorious

A World Health Organization Emergencies Expert Committee has once again re-asserted a recommendation to abolish vaccine requirements for international travel – going well against the grain of current trends – particularly in light of the brouhaha seen over Sunday’s deportation of Serbian tennis star Novak Djokovic  from Australia.

The WHO expert group, made of some 19 representatives from different WHO regions and another dozen advisors, also recommended that all restrictions on  international travel between countries be removed –  or at least eased – saying that “they do not provide added value and continue to contribute to the economic and social stress” of various WHO member states.

While that latter recommendation is something that countries are already implementing in practice – the one regarding vaccine passports has received far less  support among WHO’s own member states so far – many of which have strengthened vaccine mandates for travel, work and leisure activities over past months, including moves by France on Sunday – stimulating more protests by anti-vax groups.

Tennis Star Case Highlights Clashing Approaches

The most vivid illustration of the starkly clashing approaches of the world health body and many of its leading donor governments was Australia’s deportation on Sunday of the vaccine-hesitant Djokovic, after he entered the country to compete in the Australia Open on the basis of his recent infection and recovery from COVID-19, only to be deported by Immigration Minister Alex Hawke after a nine-day long legal battle.

Now, it appears that the 20-time Grand Slam title holder may also be barred from attending the upcoming French Open tennis tournament, after France  tightened its travel rules to bar unvaccinated arrivals – and the Sports Ministry said Monday there would be no exemptions.

The current WHO recommendation, issued by the International Health Regulations Emergency Committee Wednesday evening, states bluntly in bold typeface that it recommends member states:

“Do NOT require proof of vaccination against COVID-19 for international travel as the only pathway or condition permitting international travel.”

But rather than concern about celebrities’ international access, the WHO expert group argues that such limitations are unfair, “given limited global access and inequitable distribution of COVID-19 vaccines.” It elaborates those concerns further in an interim paper on “considerations regarding proof of COVID-19 vaccination for international travellers.”

In addition, WHO also recommended a re-evaluation of testing and quarantine measures related to international travel, something the Agency has never supported wholeheartedly either.

The advice states: “State Parties should consider a risk-based approach to the facilitation of international travel by lifting or modifying measures, such as testing and/or quarantine requirements, when appropriate, in accordance with the WHO guidance.”

WHO experts also recommend lifting of travel bans on other countries

As for even more drastic travel bans, WHO’s recommendation is perhaps more in step with the current trends – that have seen countries lifting the bans after seeing that they failed to keep the new Omicron variant at bay.

In the WHO statement Wednesday, the Expert Committee recommended that countries, “Lift or ease international traffic bans as they do not provide added value and continue to contribute to the economic and social stress experienced by States Parties.

The Omicron wave has highlighted how such travel bans can boomerang.  Travel bans in November and December hit particularly hard and visibly against the South Africa and its neighbors – the very countries that first identified the variant – and announced it transparently to the world.  The result was global pummeling of their tourism-dependent economies and hamstrung travelers desperately trying to visit family for holidays from different corners of the globe.  Some countries imposed continent-wide bans against Africans before they were applied to Europe and the United States – even cases quickly appeared all over the world, prompting leaders like South African President Cyrus Ramaphosa to refer to “health apartheid” with respect to the travel rules, while UN Secretary General Antonio Guterres called it “travel apartheid” outright.

The WHO advice underlines those points stating that: “The failure of travel restrictions introduced after the detection and reporting of Omicron variant to limit international spread of Omicron demonstrates the ineffectiveness of such measures over time.”

That advice, however, also reiterates the Agency’s ambivalence over a range of other travel-related preventative measures as well, noting that “masking, testing, isolation/quarantine, and vaccination” should be based on “risk assessments, and avoid placing the financial burden on international travellers in accordance with Article 40 of the IHR.” It refers to the WHO advice for international traffic in relation to the SARS-CoV-2 Omicron variant for further guidance.

WHO uneasy with vaccine mandates generally

Katherine O’Brien, Director WHO Vaccines, Immunizations and Biologicals

While WHO has been adamant that every country in the world needs to get to a 70% vaccine coverage goal by mid-2022 – it has been equally reticent about using vaccine mandates domestic as well as international – as a carrot or stick to reach such ambitious vaccine goals.

In early December, WHO’s European Regional Director, Dr Hans Kluge declared that vaccine mandates even in countries with universal access to vaccines should only be an “absolute last resort, and only applicable when all other feasible options to improve vaccination uptake have been exhausted.”

Last week, in response to the Djokovic controversy, WHO’s Director of Immunization, Vaccines and Biologicals, was quoted by the Sydney Morning Herald saying that “Free and full access to safe and effective vaccines is the absolute precondition before a mandate is made and that is a grounding principle,” she said.

“It’s also a grounding reason why there is not a requirement from WHO, [there is not] a recommendation around any requirement for crossing international borders, although the status of somebody’s vaccination may be considered with respect to other conditions that may be imposed on people through the course of their travel.”

Image Credits: Wikipedia , AFP/Issouf Sanogo.

Merck laboratory that developed the new oral COVID treatment, molnupiravir

The Medicines Patent Pool (MPP) said Thursday that it had already signed agreements with 27 generic manufacturing companies for the manufacturing of the oral COVID-19 antiviral medication molnupiravir and supply in 105 low- and-middle-income countries (LMICs).

The sublicense agreements are the result of the voluntary licensing agreement signed by MPP and MSD in October 2021 to facilitate affordable global access for the new COVID treatment, one of two that has recently received approval from the US Food and Drug Administration.

In comparison with Pfizer’s Paxlovid, Monulpiravir emerged with lower efficacy ratings and more potential adverse effects, in the FDA’s final reviews of clinical trial results. This has dampened enthusiasm about the drug in some countries, including India which has so far refrained from recommending it as a COVID treatment. even though the drug is already in production with a local manufacturer.

Even so, experts also the Merck drug is still regarded as an important new tool in countries’ arsenals because it can be administered to certain patients unable to tolerate Paxlovid.

MPP licenses come even before WHO issues recommendation on use of new oral drugs

Strikingly, WHO has yet to approve either Paxlovid or monulpiravir – a step that is usually regarded as preliminary to the negotiation of manufacturing licenses by a UN-supported group like the MPP.

A WHO Guidelines Development Group meeting that is scheduled to review Paxlovid [nirmatrelvir] on 9 February, a WHO spokesperson told Health Policy Watch last week, but declined to comment on when the Merck drug will be reviewed.

The non-exclusive licenses allow generic manufacturers to produce the raw ingredients for molnupiravir and/or the finished drug itself.

In a press release, the Geneva-based MPP said that the companies that were offered the sublicense successfully demonstrated their ability to meet MPP’s requirements related to production capacity, regulatory compliance, and the ability to meet international standards for quality-assured medicines. Five companies will focus on producing the raw ingredients, 13 companies will produce both raw ingredient and the finished drug and 9 companies will produce the finished drug. The companies span 11 countries, Bangladesh, China, Egypt/Jordan, India, Indonesia, Kenya, Pakistan, South Africa, South Korea, and Vietnam.

While MSD negotiated an agreement with MPP that establishes the terms and conditions, the requests for sublicences from generic producers were reviewed solely by MPP and presented to MSD. Neither MSD nor its collaborators in the R&D at Ridgeback Biotherapeutics, nor Emory University, which invented the drug, will receive royalties from sales of molnupiravir from the MPP sublicensees while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.

“We are encouraged by the large number of new and existing partners that have moved quickly to secure a sublicence for molnupiravir through MPP,” said Charles Gore, MPP Executive Director. “This is a critical step toward ensuring global access to an urgently needed COVID-19 treatment and we are confident that, as manufacturers are working closely with regulatory authorities, the anticipated treatments will be rapidly available in LMICs.”

“Accelerating broad, affordable access to molnupiravir has been a priority for MSD from the start, which led us to partner with MPP on a licensing agreement to expand access to quality-assured generic versions of molnupiravir, subject to local regulatory authorisation,” said Paul Schaper, Executive Director, Global Public Policy, MSD. “We are pleased to see this vision come to life, with strong geographic diversity in MPP’s selected generic manufacturing sublicensees.”

More on MPP’s licence on molnupiravir and on the sublicence agreements : https://medicinespatentpool.org/licence-post/molnupiravir-mol

Image Credits: Merck .

Surveillance for antimicrobial resistance (AMR) in Southeast Asia – much more is needed to combat rising mortality from drug resistant diseases in low-income countries.

Antibiotic-resistant bacterial infections killed 1.27 million people in the world in 2019, according to a one-of-a-kind study in The Lancet.

According to the study, led by the Institute of Health Metrics and Evaluation (IHME) at the University of Washington, with dozens of authors worldwide, the increased resistance of many common pathogens to treatment, known as antimicrobial resistance (AMR), was a leading cause of death worldwide in 2019.

AMR caused more fatalities than HIV/AIDS or malaria, which caused 860,000 and 640,000 deaths respectively, in the same time period.  More people than ever are dying from previously treatable infections since the bacteria causing such infections have become resistant to previously life-saving drugs.

Deaths from AMR were estimated to be highest in sub-Saharan Africa and South Asia, at 24 deaths per 100,000 and 22 deaths per 100,000 people respectively. Children were among those most likely to die of antibiotic-resistant pneumonia strains. In contrast, in high-income countries, the death toll from AMR was about 13 deaths per 100,000.

The study is the first to comprehensively estimate annual deaths from AMR – a global risk that so far has lacked systematic quantification, including by the World Health Organization (WHO). The study highlights how a number of common respiratory pneumonia and bloodstream infections that were previously treatable – have become antibiotic-resistant to treatment causing hundreds of thousands of deaths a year.

Action is needed now to combat the rising threat

The health impact of pathogens varied widely based on location, with deaths attributable to AMR in sub-Saharan Africa most often caused by S. pneumonia (16% of deaths) or K. pneumonia (20%) – the latter is portrayed here.

“These new data reveal the true scale of antimicrobial resistance worldwide, and are a clear signal that we must act now to combat the threat,” said study co-author Chris Murray, director of IHME.

“Previous estimates had predicted 10 million annual deaths from antimicrobial resistance by 2050, but we now know for certain that we are already far closer to that figure than we thought. We need to leverage this data to course-correct action and drive innovation if we want to stay ahead in the race against antimicrobial resistance.”

The 10 million deaths refers to data from a UK government-commissioned study. That number was a benchmark for the landmark 2019 UN report on AMR that warned of a looming crisis, called “No Time to Wait”. But it has been widely criticized inside WHO and elsewhere as lacking precise current data. The Lancet study should fill that gap. 

The study included a review of nearly 10,000 sources, including literature, lab data, household surveys and national mortality data. The research and modelling of trends extend across 204 countries and territories – thus covering virtually every place on the planet. It assessed some 88 pathogen–drug combinations. Of the 23 pathogens studied, lower respiratory and thorax infections, bloodstream infections, and intra-abdominal infections accounted for 78.8% of the deaths caused by AMR in 2019.  

While 1.27 million deaths were directly attributable to AMR, 4.95 million deaths were somehow associated with drug-resistant infections in 2019, the study also found – meaning that drug-resistant infections were a factor in morbidity, even if they could not be deemed as the cause of death.

The paradoxical reasons cited for growing resistance to treatment include both problems of excessive and inappropriate use of antibiotics, but also insufficient access to the drugs even in the same geographical areas. This is a particular problem in low-income settings where access to a wide array of medicines is more restricted. 

Which pathogens are the most resistant? 

Six pathogens were associated with the greatest burden of AMR deaths: E coli, Staphylococcus aureus, K pneumoniae, S pneumoniae, acinetobacter baumannii, and Pseudomonas aeruginosa. These collectively accounted for over 900,000 of the 1.27 million deaths caused by drug resistance in 2019. 

S.aureus and E.coli were the leading cause of deaths in high-income regions in 2019, while resistance to  S pneumoniae and K pneumoniae were the biggest killers in sub-Saharan Africa. 

Meanwhile, resistance to two main antibiotics considered the go-to responses for severe infections – fluoroquinolones and beta-lactam antibiotics, including penicillins and cephalosporins – was responsible for over 70% deaths

Global deaths (counts) attributable to and associated with bacterial antimicrobial resistance by infectious syndrome, 2019

Poorer countries have it worse  

The study also highlights the large regional disparities in the worldwide scale and spread of bacterial-related AMR.

Western sub-Saharan Africa accounted for the highest burden of such resistance with 27.3 deaths per 100,000 directly attributable to the resistance while 114.8 deaths per 100,000 were associated with bacterial AMR. Contrast this with the Australasia region which saw the lowest AMR burden in 2019 at 6.5 deaths per 100,000 attributable to AMR and 28 deaths per 100,000 associated with AMR. 

The entire sub-Saharan Africa region, and south Asia region had an estimated all-age death rate of 75 per 100,000 associated with bacterial AMR. 

All-age rate of deaths attributable to and associated with bacterial antimicrobial resistance by GBD
region, 2019

According to the study, the higher AMR burden is both a function of the prevalence of resistance as well as the underlying frequency of critical infections such as lower respiratory infections, bloodstream infections, and intra-abdominal infections –which are seen to be higher in these regions. 

“Some of the AMR burden in sub-Saharan Africa is probably due to inadequate access to antibiotics and high infection levels, albeit at low levels of resistance, whereas in south Asia and Latin America, it is because of high resistance even with good access to antibiotics,” commented Dr Ramanan Laxminarayan, founder and Director of the Center for Disease Dynamics, Economics & Policy, in Washington, DC, writing in a linked Comment.

In November, WHO’s Africa Region said that over four million Africans a year could die as a result of antimicrobial resistance by 2050. 

The way forward: Vaccines, better infrastructure and more data 

Along with more appropriate use of antibiotics, insure both access but not excessive use, vaccinations also are paramount for combating AMR, the study’s authors underlined. 

And this includes vaccines against viral pathogens like influenza, respiratory syncytial virus, and rotavirus  – which in turn reduce the risks of secondary bacterial infections and subsequent treatment, which means less dependency on inappropriate antibiotic consumption. 

At the same time, there is an urgent need to reduce the use of antibiotics as a first-line treatment for viral infections, in which case antibiotics are not effective.  

Given that AMR affects low-and-middle-income countries more than higher-income ones, the study also recommends scaling up and building stronger diagnostics infrastructure that allow clinicians to diagnose infection more accurately and rapidly.  At the same time, the study shows, maintaining investment in the development pipeline for new antibiotics, and access to second-line antibiotics in locations without widespread access is essential. 

“From being an unrecognised and hidden problem, a clearer picture of the burden of AMR is finally emerging,” Laxminarayan said in his comment, noting that spending on HIV “attracts close to US$50 billion each year. However, global spending on addressing AMR is probably much lower than that. This needs to change.

“Spending needs to be directed to preventing infections in the first place, making sure existing antibiotics are used appropriately and judiciously, and to bringing new antibiotics to market. Health and political leaders at local, national, and international levels need to take seriously the importance of addressing AMR and the challenge of poor access to affordable, effective antibiotics.”

Data gaps hinder assessment – particular in low-income countries

Testing for antimicrobial resistance among a variety of different bacterial strains

This study was funded by the Bill & Melinda Gates Foundation, Wellcome Trust, and Department of Health and Social Care using UK aid funding managed by the Fleming Fund.

But the international consortium that authored the study, the Antimicrobial Resistance Collaborators, identified serious data gaps in many low-income countries, underlining the importance of increasing laboratory capacity and data collection in these locations.

This is all the more critical insofar as resistance varies substantially by country and region – both in terms of what bacteria are more resistant and what drugs are more or lesss effective, researchers stressed.

“Improving the collection of data worldwide is essential to help us better track levels of resistance equip clinicians and policymakers with the information they need to address the most pressing challenges posed by antimicrobial resistance,” said Professor Christiane Dolecek, at Oxford University’s Centre for Tropical Medicine and Global Health and the Mahidol Oxford Tropical Medicine Research Unit.

In his comments, Laxminarayan also emphasized the need for more AMR data collection in low-income countries saying: “Progress ahead will depend on projects such as those supported by the Fleming Fund, which aim to improve laboratory capacity in LMICs while also uncovering resistance data that lie on dusty shelves and in long-forgotten hard drives.”

Report is ‘wake-up call’

Senior WHO officials, including Chief Scientist Soumya Swaminathan,  welcomed the new IHME report as filling a critical knowledge gap and highlighting the long-neglected issues around AMR.

“Lack of robust global data and evidence of the impact of drug-resistance has been a critical knowledge gap and has hampered efforts to advocate for policies and practices to control antimicrobial resistance,” said WHO in a series of tweets. “This study now clearly demonstrates the existential threat”.

Meanwhile, pharma voices described it as a ”wake up call”:

“Left unchecked, AMR could undermine the foundation of modern medicine,” said Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations.

“This is a wake-up call for us all, industry has been a first mover in finding solutions.  Now the focus has shifted to governments who must deliver new economic incentives, pragmatic antibiotic value assessments, and reimbursement reforms to enable access, that are needed to meet the needs of patients of today and tomorrow.”

  • Updated 23 January 2022

Image Credits: WHO, USAID Asia/Flickr, The Lancet, DFID – UK Department for International Development.

The WHO Executive Board discussion on the coronavirus outbreak in early February 2020 – the last full-scale face-to-face meeting in Geneva of the governing body before WHO declared an international health emergency.

One of the more complicated tasks facing next week’s World Health Organization (WHO) Executive Board (EB) is how to take forward negotiations on an ‘instrument’ to address future pandemics – and even the report to the board about this has been slashed.

The past two years of vaccine hoarding, nationalism and fights about the origins of SARS-CoV2 have made it plain that finding global agreement on how to address future pandemics might be impossible.

Although the special session of the World Health Assembly late last year agreed that the WHO would actually try to do this, the working group charged with trying to develop a negotiation plan has struggled to find consensus.

The EB report from the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGSWP) was nine pages at the start of the group’s meeting last week – but the latest version is down to six pages.

The entire clause that suggested that the WHO should have speedy access to disease outbreak sites has been removed – at the insistence of China, diplomatic sources told Health Policy Watch.

The entire clause 11 has been removed from the original report

The report identifies two key priorities to frame future pandemic response – equity and building systems and tools, including strengthening the International Health Regulations (IHR) and adopting a ‘One Health’ approach.

It proposes that IHR be tightened up to “provide clear guidance for action in the event of a public health emergency of international concern with the potential to establish immediate alerts”.

However, that is as close as it gets to the original report suggesting that the WHO might be empowered to get to outbreaks in countries as speedily as possible.

The WGSWP report, part of EB agenda item 15 on public health emergencies preparedness and response, is due to be addressed on the first day, Monday 24 January.

The board will be expected to “provide further guidance” on the report. It will also consider the creation of a Standing Committee on Pandemic and Emergency Preparedness and Response “to provide guidance and, as appropriate, make recommendations to the Board regarding ongoing work on policy proposals on pandemic and emergency preparedness and response”.

Agenda focuses on four pillars 

The agenda of EB, meeting for the 150th time, has been organised around four pillars:

  • One billion more people benefitting from universal health coverage;
  • One billion more people better protected from health emergencies;
  • One billion more people enjoying better health and well-being;
  • More effective and efficient WHO providing better support to countries. 

A significant focus of the board meeting will be on non-communicable diseases (NCDs). By Wednesday, the EB is expected to have adopted a “draft implementation road map 2023–2030” to prevent and control NCDs. 

Proposals to reduce the harmful use of alcohol, better control diabetes, improve oral health and ensure that people with NCDs can still access treatment during humanitarian emergencies form part of the draft policies.

The NCD Alliance is calling on member states to put the draft policies related to NCDs forward for adoption to the 75th WHA.

The EB will also appoint the Director-General for the next four years – and the only candidate officially nominated so far is the current office-bearer, Dr Tedros Adhanom Ghebreyesus.

 

Image Credits: HPW/Catherine Saez.

South African President Cyril Ramaphosa and US billionaire Dr Patrick Soon-Shiong

CAPE TOWN – South African-born US biotech billionaire Patrick Soon-Shiong launched a vaccine manufacturing plant in the country of his birth on Wednesday, aimed at producing “second generation” vaccines to address COVID-19 and other diseases.

Soon-Shiong, who has made his fortune from developing successful cancer treatments, has committed an initial $195 million to NantSA – the South African operation that aims to produce one billion vaccine doses a year by 2025.

Soon-Shiong said that he had been moved to invest in improving South Africa’s vaccine capacity after witnessing “vaccine apartheid” during the COVID-19 pandemic.

Unlike current vaccines that are based on stimulating the body to produce antibodies, Soon-Shiong’s approach is based on stimulating the body’s T-cell responses – something he has done successfully in cancer immunotherapy treatment.

His US company, NantKwest, has been developing “natural killer” (NK) cells used by the immune system to identify and destroy cells under stress, including cancerous or virally-infected cells.

NantKwest describes itself as “a pioneering, next-generation, clinical-stage immunotherapy company” that is focused on “harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases”. It has not yet developed a commercial product based on NK cells.

‘Vaccine apartheid’ prompted investment

“We have spent 10 to 15 years trying to show that, while antibodies are important, T cells are what kill. We came from the position of cancer, and we took that same technology and have actually put it into vaccines,” Soon-Shiong told the launch in Cape Town.

But he admitted that this approach has been “really difficult for people to grasp at the regulatory level, at the science level, at the implementation level”.

“We started this in the US, but then when I saw the need, the inequities that I call vaccine apartheid, that was happening here on this continent and within the encouragement of [South African] President Cyril Ramaphosa, I said this is what we needed to do and we’ve moved our focus to South Africa.”

‘Part of Africa plan’, says South Africa’s President

Opening the facility, Ramaphosa said that the “state-of-the-art vaccine manufacturing campus” was “part of a far broader initiative to propel Africa into a new era of health science”.

“Today we are marking the establishment of a company that aims to develop next-generation vaccines that will reach patients across the continent,” added Ramaphosa.

“This new entity, we understand, will collaborate with the [World Health Organization] mRNA hub by providing RNA enzymes they need to produce vaccines.”

Ramaphosa also praised the $6.7million investment made by Soon-Shiong’s family foundation to train young Africans in biotechnology and life sciences.

Part of this investment involves the establishment of the Chan Soon-Shiong Centre for Epidemic Response and Innovation at the University of Stellenbosch, which includes the donation of two large DNA sequencers.

 “South Africa’s capabilities in genomic surveillance are recognised worldwide and have been vital in our response – and indeed the global response – to the emergence of new COVID-19 variants,” said Ramaphosa.

The event also marked the launch of the Coalition to Accelerate Africa’s Access to Advanced Healthcare (AAAH Coalition) which, together with NantSA, “aims to accelerate domestic production of pharmaceuticals, biologics and vaccines that will reach patients across the African continent”, according to the South African Presidency.

This would accelerate self-reliance and Africa’s preparedness to face the next pandemic, added Ramaphosa.

Soon-Shiong, one of the wealthiest medical doctors in the world, has also been described as a “blowhard” and a “showman” by Forbes magazine – although the magazine also quoted a patient who said that his experimental pancreatic cancer treatment had saved his life.