Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy and not geographic or national origins, Africa CDC Director Dr John Nkengasong has said.

IBADAN – Five African countries have now confirmed cases of the SARS-CoV-2 501Y.V2 variant, which first appeared in South Africa, and there is concern that the variant is circulating undetected elsewhere on the continent. The Gambia and Nigeria have seen cases of the variant B.1.1.7, first identified in the United Kingdom, said WHO’s African Regional Director today, Dr. Matshidiso Moeti, at a press briefing.

Meanwhile, Africa CDC Director, Dr John Nkengasong, called for a “common approach” to COVID testing to oil the wings of international air travel – and halt the wave of new travel restrictions that countries have been imposing based on people’s national origin or the origins of flights – including people and flights arriving to Europe and the United States from South Africa.

Researchers now believe the variants may be both more infectious but also more deadly than the COVID virus strains that were prevalent until just recently. Researchers also fear the variants could also elude COVID tests and be more resilient to vaccines just being rolled out now – although many unknowns remain.

The countries where 501Y.V2 is circulating include: Botswana, Ghana, Kenya and Zambia, as well as South Africa. Beyond Africa, the variant has been confirmed in 24 countries globally. And there’s concern, it is circulating undetected in other countries in Africa,” Moeti told the press briefing.

Dr. Matshidiso Moeti, WHO’s African Regional Director.

“We are seeing more and more cases of variants and 501Y.V2, which was first identified in South Africa now, cropping up in other countries,” Moeti said. “The evidence suggests that these variants are more transmissible and emerging evidence indicates that the UK variant may cause more severe illness than other common strains, although more research needs to be done.”

These variants in conjunction with “the aftermath of year-end gatherings”, Moeti said, “risk powering a perfect storm and driving up Africa’s second wave and overwhelming health facilities”.

The continent saw a 50% rise in infections between 29 December 2020 and 25 January 2021, when compared with the previous four weeks, while deaths doubled.  Last week, more than 6,200 deaths were reported across Africa, said the WHO.The past week saw a small dip in cases in South Africa, but 22 other countries continued to see numbers surge.

Existing COVID-19 vaccines remain effective against the variants, Moeti said. But Professor Tulio de Oliveira, of the University of KwaZuku-Natal, South Africa, noted that these or other emerging variants may likely require individuals receiving booster doses of the vaccine.

WHO’s African Region is meanwhile setting up a new surveillance network with Africa CDC to track the spread of the virus mutations and variants across Africa and beyond, Moeti added.

“The variant which was first detected in South Africa has spread quickly beyond Africa and so what’s keeping me awake at night right now is that it’s very likely circulating in a number of African countries,” said Moeti. “Africa is at a crossroads. We must stick to our guns and double down on the tactics we know work so well. That is mask wearing, handwashing and safe social distancing. Countless lives depend on it.”

WHO’s African CDC Calls for Common COVID Testing Approach For International Travel

Dr John Nkengasong issued his call for a rethink of travel policies after several foreign countries, including the United States, are considering or have already banned flights originating from South Africa. Travel restrictions aiming to limit the importation of variants should be based upon a systematic testing policy – and not geographic or national origins, said Nkengasong.

“We should not be banning people because of their geographical origin, but we should be encouraging people to travel with negative tests and facilitate the testing process so that people can travel with a negative test,” Nkengasong said.

“If I were to go to Kenya and I show up at the airport with a valid negative test, I pose no threat to the country of Kenya, and that way so you shouldn’t just ban me because I’m coming from a certain country. They should be looking at that test, is your test valid,” Nkengasong added.

Dr John Nkengasong, Director of the Africa CDC.

Up until now, the World Health Organization has resisted recommending pre-travel COVID testing, ostensibly due to fears that it would put an unnecessary onus on poor countries.

In fact, however, many of the poorest African and Asian countries have been requiring pre-flight COVID tests for all incoming passengers – which are paid for privately. Some counties, such as the Democratic Republic of Congo, also demand arrivals briefly quarantine until a post-flight test is completed as well, paid privately as well.

Paradoxically, it is wealthier European and American countries that first issued a rash of orders banning passengers of certain nationalities or flights from certain destinations as a result of variant scares – although more developed countries, most recently Switzerland on Wednesday, have adopted testing requirements.

Senegal’s Pasteur Institute – At Center Of New Genetic Surveillance Network

At the outset of the pandemic, most countries in Africa lacked adequate testing capacity for COVID-19 but this was gradually surmounted as new testing facilities were added.

Now, however, the identification of new variants of the virus will require more advanced capacities for gene sequencing that several countries in Africa have yet to obtain.

To address this vacuum, the Africa CDC, the WHO and member countries have created a network that enables existing labs with gene sequencing capabilities to collect samples from countries that lack such.

One of the labs in the network is the Dakar-based Institut Pasteur de Dakar in Senegal. Its CEO, Dr Amadou Sall, said in addition to providing gene sequencing services for Senegal, the institute is now supporting other countries, Cameroon and Equatorial Guinea notably. Others include Mali, Burkina Faso Guinea-Bissau, Côte d’Ivoire, Niger, Verde, and of course, Guinea.

“With the partnership we have with Africa CDC and WHO, we have the possibility of sequencing 500 genomes per week. And we’re trying to increase this capacity and to make these capacities available in different countries,” Sall said.

Key to the success of COVID-19 genomic surveillance in Africa, Sall said, will be the willingness and openness of African countries to share information.

“We need to be able to share information data and the Pasteur Institute is at the center of a global platform and we’re able to share information; to exchange information rapidly, if countries are willing to do so,” he said.

Knowing When to Raise the Alarm

While noting that identification of new variants is a significant feat, genomic experts warned that alarm should not be raised every time a new strain is identified.

Professor de Oliveira, who heads the KwaZulu-Natal Research and Innovation Sequencing Platform, said attention is raised when new strains are being confirmed in increasing numbers of cases with the new variant and not when just one case has been confirmed.

Describing the impacts that variants have on the epidemiology of the pandemic in South Africa, Oliveira said in some regions, the new variant has become the prominent type. But beyond this, he said South Africa is also worried about the variants from elsewhere getting into the country and circulating among its populations.

“Today, we just reported the first important case of the B.1.1.7, the variant of concern that is circulating in the UK. And it’s quite common that in addition to our main variant that is dominating, we’re going to still have introductions of new lineages,” Oliveira said.

“And in the case they begin to spread very fast, then we will communicate it and then highlight that could be a variant of concern.”

He said that while no one can know for sure about the possibility of third or fourth waves of the pandemic in Africa, the variants are highlighting the need for the entire world to globally control the transmission of  SARS-CoV-2 as a global community.

“We have to really decrease transmission to avoid the next waves and more worry that emergence of new variants of concern will transmit too fast or evade immune response,” he said.

“The appearance of these variants in the African continent, but also in South America and Europe really means that more than ever, it is the time that we don’t leave any continent behind, especially on vaccination,” Oliveira said.

Silver Lining In Cloud – Variants Also Impetus For Cooperation

But within Africa itself, Sall said the various SARS-CoV-2 variants constitute a new impetus for cooperation between countries, to be able to track and measure the circulation of the virus, and to enhance diagnostic capacities that he said will soon be available across Africa.

“The new variants are the object of a very thorough study, and the path of our countries is very clear: obtain maximum information and adapt the strategy to contain the transmission,” he said.

Moeti enjoined countries and individuals to strive to overcome COVID-19 fatigue and return to the fundamental actions that have been found to be effective against these variants. These measures, she said, need much more emphasis that news that the virus is much more transmissible.

“The vaccine is a tool that’s going to make a huge difference all over the world,” she said.

But she reminded that “having a corner of the world not protected, the way the world’s economies and peoples are connected, will have negative economic impact even in those countries that managed to vaccinate the entire population. We really are all in it together, and we have to work to support each other to overcome this global crisis.”

Image Credits: Paul Adepoju/HealthPolicyWatch, Africa CDC.

The Oxford/AstraZeneca vaccine is 2 months behind schedule due to an issue in manufacturing.

AstraZeneca has joined Pfizer in announcing delays in deliveries of COVID-19 vaccines to countries in Europe, leading furious EU officials to plan for a system of tighter monitoring of vaccine exports. 

The British-Swedish pharma company that developed its COVID-19 vaccine with researchers at Oxford University, informed the European Commission on Friday that there would be a 60% shortfall in vaccine deliveries this quarter due to a manufacturing issue at a production plant in Belgium. 

The company is reportedly two months behind schedule with regard to vaccines destined for European countries. Since vaccine deals with the United States and the United Kingdom were signed earlier on, and are based around manufacturing sites in those countries, the company has had a headstart in resolving “glitches” in those supply chains, pharma officials said.

But the Commission had its doubts over this given explanation.

Following an EU-requested investigation into AstraZeneca’s Belgian-based production facility on Wednesday, the European Commission has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines.

The mechanism – the criteria for which is expected to be published on Friday – could throw the security of the UK’s 40m-dose deal with Pfizer/BioNTech.

The investigation, a spokesperson for the Belgian health ministry said, was to “make sure that the delivery delay is indeed due to a production problem on the Belgian site”.

AstraZeneca ‘Scaling Up’ Doses, As EU Leaders Question Pharma Company
Pascal Soriot, CEO of AstraZeneca

“We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed. A year ago we didn’t have a vaccine. When you do that, you have glitches, you have scale-up problems. Therefore, the yield varies,” said Pascal Soriot, CEO of AstraZeneca, in an interview with la Repubblica, an Italian newspaper, on Tuesday. 

News of the delays was met with frustration by EU officials and leaders, who were expecting to receive 80 million doses by the end of March. 

“This new schedule is not acceptable to the European Union,” said Stella Kyriakides, European Commissioner for Health and Food Safety, in a statement released on Monday. “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far, and if, or to whom, they have been delivered.”

Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Wednesday.

Soriot disputed suggestions that the company sold the doses elsewhere for a higher price, claiming that “there is a lot of silly talk going on right now about all sorts of things,” and the response from the European Commission and EU member states is because “there are a lot of emotions running in this process right now.”

“The suggestion [that] we sell to other countries to make more money is not right because we make no profit everywhere…That’s the agreement we have with Oxford University,” said Soriot. 

“Governments are under pressure. Everybody is getting kind of…aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe,” he added. 

In late August, the EU made an upfront payment of €336 million to the company to secure 300 million doses of the vaccine. EU officials have disputed AstraZeneca’s explanation of production issues, claiming there are no excuses for the delay. 

“The flimsy justification that there are difficulties in the EU supply chain but not anywhere else does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said Peter Liese, an EU parliamentarian from Germany’s Christian Democratic Union.

Currently AstraZeneca is producing 17 million doses per month. That number will reach 100 million doses from February onwards, according to Soriot, meaning 1.2 billion doses per year. And Europe will receive 17% of the global production in February for a population that represents 5% of the world’s population. 

The Oxford/AstraZeneca vaccine is in the final stages of the approval process with the European Medicines Agency (EMA) and is expected to receive the recommendation for market authorization on Friday. After being approved, the company plans to deliver three million doses immediately. 

Meetings between EU officials and AstraZeneca have done little to resolve the issue, with Kyriakides announcing on Twitter: “Discussions with @AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations. EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold.”

The EU Steering Board, the body that oversees vaccine deals, plans to meet with AstraZeneca again on Wednesday at 6:30pm CET and hopes to “resolve this in a spirit of collaboration and responsibility,” according to Kyriakides. 

The Italian government plans to take legal action against Pfizer and AstraZeneca over their delays in deliveries, according to an announcement made by Foreign Minister Luigi Di Maio on Sunday. 

“This is a European contract that Pfizer and AstraZeneca are not respecting and so for this reason we will take legal action,” Di Maio said on RAI state television. “We are activating all channels so that the EU Commission does all it can to make these gentlemen respect their contracts.”

According to Soriot, however, the vaccine deal signed with the EU was not a contractual commitment but a best effort, so there is no feasible basis for legal action. 

EU to Establish a Vaccine Export Transparency Mechanism

The Oxford/AstraZeneca vaccine is also considered one with global potential – due to its ability to be stored at refrigerator temperatures. Amidst some countries’ suspicions that countries outside Europe are receiving priority for vaccines produced at the Belgium plant, the European Commission announced plans to establish an export transparency mechanism for vaccines to ensure clarity on transactions and to protect its investments in the R&D that led to development of vaccines like AstraZeneca’s.

AstraZeneca is also a major supplier of the WHO COVAX global distribution initiative – which has pledged to begin distributing vaccine doses to the 92 lowest-income countries in the world within the next two months. Although most of the COVAX supplies were reportedly to be produced by India’s Serum Institute or in the Republic of Korea, the exact supply lines remain unclear. 

“Europe invested billions to help develop the world’s first COVID-19 vaccines…And now, the companies must deliver,” said Ursula von der Leyen, President of the European Commission, at the World Economic Forum on Tuesday. “They must honor their obligations. This is why we will set up a vaccine export transparency mechanism. Europe is determined to contribute to this global common good. But it also means business.”

Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum on Tuesday.

“In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” said Commissioner Kyriakides. 

The aim of the proposed system will be to monitor, but not block, exports, officials said. And humanitarian deliveries would be anyway exempt from this oversight mechanism. 

EMA Yet To Issue Final Approval – Insufficient Data on Vaccine in Older People

Meanwhile, the EMA has yet to issue its final regulatory approval for the two-dose Oxford/AstraZeneca vaccine, and is reportedly considering limiting the age range to people under the age of 65 – due to a lack of data on effectiveness in older people. Unlike mRNA counterparts produced by Moderna and Pfizer, the AstraZeneca/Oxford vaccine uses a disabled, modified version of a chimpanzee adenovirus that can enter human cells but cannot replicate or cause the disease, as a vector to deliver a fragment of SARS-CoV2 spike protein, stimulating COVID-19 immunity. 

According to data shared by the company, only 10% of participants in the vaccine clinical trials were over the age of 65 because it was first waiting for sufficient safety data in the 18 to 55 age group before vaccinating older individuals. 

“We don’t have a huge number of older people who have been vaccinated,” said Soriot. “But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people.”

The results of an ongoing, larger Phase 3 clinical trial with 30,000 participants being conducted in the United States are expected to provide insight into the protection the vaccine provides to older individuals and ethnic minorities populations –  groups that were not very well represented in previous trials. 

In addition, scientists are exploring whether a half-dose of the first vaccine would reliably yield a higher efficacy rating of 90% that was seen in initial trials. The other regime, involving two full doses was only 62% effective, according to the results released by the company in late November and reviewed by an independent Data and Safety Monitoring Board. That still meets key global benchmarks for efficacy, but is significantly lower than the 94-95% efficacy results for the Moderna and Pfizer mRNA vaccines.

The AstraZeneca vaccine has, however, already been authorized in the UK, is already being used in British vaccination campaigns, including for people over 70 years old.

Image Credits: AstraZeneca, AstraZeneca, Twitter, Twitter.

Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, according to WHO.

The World Health Organization (WHO) aims to make its engagement with non-state actors (non-state actors) more meaningful and efficient with a new proposal to establish a number of NSA fora that would allow exchange with WHO and member state representatives outside of official meetings.

The new proposal — which will be tested during the 74th World Health Assembly (WHA), 24 May to 1 June — would offer multiple side events in which non-state (NSA) actors could engage more informally with member state representatives as well as a forum for exchange between NSAs and WHO regional and technical staff.

But at the same time, non-state actors will be allotted a more limited number of constituency statements in formal governing body meetings – and like-minded groups of actors will be asked to combine their official statements together.

Non-state actors include civil society groups such as non-governmental organizations, international business and professional associations, and philanthropic foundations. More than 70 non-state actors are recognized as being “in official relations” with WHO, and thus contribute in formal meetings such as the EB and the WHA.

However, EB and WHA members have complained that the civil society interventions have become bogged down by too many lengthy, individual statements – and NSAs acknowledge that the statements often had limited impact in member state debates.

More informal meetings ahead of the formal meeting dates would help engender more meaningful interaction, WHO said in its proposal for the reform, which was reviewed by the WHO Executive Board on Saturday. Informal meetings will also allow non-state actors to organize themselves into constituencies, consolidating their positions into joint statements to be presented at official events.

The new arrangements to be tested in May, will “serve as a trial for potential future virtual informal meetings between non-state actors, Member States and the Secretariat, as a means of enabling more in-depth technical exchanges, as well as discussions on the Health Assembly agenda items,” said the WHO Secretariat, in its presentation to the EB on Saturday.

The COVID-19 pandemic has provided added impetus for reforms that have long been in the making – insofar as the limitations of virtual meetings have also curtailed the interactions between member states and non-state actors.

According to the new proposal, the informal series of meetings with non-state actors will be held just ahead of the WHA, and thus prepare the groundwork for the formal meeting.

Role of Non-State Actors Has Evolved – But Increasing Number of Statements Detracted from Impact

In the discussion over the proposal, WHO officials stressed that the Organization “is and remains a Member State Organisation” — engaging with 77 non-state actors, at global, regional and country levels, who also support the development and implementation of the Organization’s policies and recommendations, technical norms and standards.

But while non-state actors have “served the Organization well for several decades”, the increasing number of non-governmental organizations and other non-state actors participating — often with a greater number of requests to speak — has “not resulted in a more meaningful involvement”.

For example, when civil society representatives speak one-by-one at the end of a discussion, their interventions have little impact on the content or direction of the debate, WHO contends.

Member States and non-state actors alike have expressed dissatisfaction with the current system, albeit for different reasons, says the WHO.

A virtual consultation by WHO further confirmed that non-state actors’ primary interests in attending governing body meetings are to participate in technical exchanges with the Secretariat and the Member States and to attend consultative hearings that feed into decision-making processes.

Meaningful Participation From NGOs Critical, Member States Say

The UK delegate said that it would allow NSAs to exert even more credible influence on member states attitudes and positions. The EB representative from the United States flagged that it is critical to ensure and enhance meaningful participation of non-state actors in WHO governing bodies, while also creating greater efficiency in the governance process.

“Non-State actor participation must be allowed in a transparent and accountable manner with an open door to input from all stakeholders including the private sector,” the delegate noted.

Austria pressed for the Secretariat to provide some more detailed information on the procedure for these meetings.

Other states, like Australia, flagged that the trial is very ambitious given the agenda for the 2021 assembly is already very crowded.

“We suggest that before agreeing to a trial, the number of meetings proposed to be repeated and streamlined,” the representative said.This would “provide reflections to technical areas in advance of the governing body meetings”.

Civil Society Groups Request Clarity and Procedure Details

Bodies like Health Action International asked for details as to how NGOs would participate, and for clarity on the processes governing such meetings.

“It is a remaining concern to those who have witnessed creeping capacity shrinking of NGO space and poor consultation in recent years,” said an HAI statement. The HAI delegate requested that similar procedures be implemented for WHO regional meetings with member states, also asking that  “these informal meetings compliment, but do not replace comprehensive consultations with non-state actors.”

Meanwhile, the European Society for Medical Oncology said the views and expertise of non-state actors should be introduced earlier in the WHO decision-making process; it would be of greater value if delivered at the onset of projects, and when member states are drafting zero draft decisions and resolutions.

“Direct interaction and discussion between member states, WHO offices, and Non-State actors would provide the opportunity for more in-depth exchanges, and partnerships, as the Member States, develop policies and implement actions to fulfill their WHO commitments,” said the ESMO spokesperson.

Silberschmidt stressed that the virtual informal meetings will not replace other channels, but become an additional avenue for interaction – highlighting the fact that Dr Tedros Adhanom Ghebreyesus, WHO Director General, has already established a regular dialogue with civil society groups, to be held every six weeks.

 

Image Credits: WHO / Christopher Black.

The opening press conference of the 4th HIV Research for Prevention Conference on 26 January.

While global attention has fixated on the coronavirus, the forty-year long fight against HIV, which has claimed 33 million lives, is seeing new breakthroughs in preventive tools.

New discoveries of “broadly neutralizing antibodies” as well as novel regimens of pre-exposure prophylaxis (PrEP), could strengthen the world’s toolbox to prevent the disease, announced the International AIDS Society (IAS) at the opening of the 4th HIV Research for Prevention Conference. 

The IAS-sponsored Conference, which is taking place virtually over four days, is the only conference in the world that is exclusively focused on research in HIV prevention. 

“COVID-19 has disrupted research around the world, so it’s especially exciting to see this new progress,” said IAS President Adeeba Kamarulzaman in a press release. “These research advances on options like broadly neutralizing antibodies and injectable PrEP could help significantly strengthen our HIV prevention toolkit.” 

Adeeba Kamarulzaman, President of the International AIDS Society, at the HIVR4P Conference.

The latest results on broadly neutralizing antibodies (bnAb) are particularly promising. In a pair of parallel trials, researchers from the Fred Hutchinson Cancer Research Center found that one of its bnAb’s prevented HIV infection 75% of the time over 20 months, thus providing an important “proof of concept” to prevent sexually-transmitted HIV in the future, said the study’s  authors. In this case, the bnAb’s were developed to recognize the ‘CD4’ binding site of the HIV virus.

In the two parallel trials, researchers injected participants with a placebo or two doses (10mg/kg and 30 mg/kg) of their antibody. In the American arm of the trials, enrolees included men and transgender persons who have sex with men, while the Sub-Saharan arm of the trial recruited cisgender women.

More Practical PrEP Regimens Also On Horizon

Meanwhile, two longer-acting and thus more practical PrEP regimens have been developed. They have the potential to replace common treatments that have to be taken on a daily basis, such as tenofovir/emtricitabine (TDF/FTC), also known as “Truvada”. 

They include cabotegravir, the first long-acting injectable regimen, as well as islatravir, a pill that would only need to be taken once a month.

As well as improving adherence to PrEP, these novel treatments could also bolster global PrEP uptake, which still falls short of the 3 million target set by UNAIDS despite a six-fold increase in uptake over the past four years, found the AIDS Vaccine Advocacy Coalition in a study that was also featured at the conference.

Cabotegravir – Injectable PrEP Regimen Works Better Than Existing Treatment 

Based on a study in over 3,000 women in Sub-Saharan Africa, PreP candidate cabotegravir, was deemed safe and far superior to Truvada, complementing similar findings from another earlier trial in cisgender men as well as transgender women who have sex with men.

In this latest trial, participants received either cabotegravir plus a placebo of TDF/FTC or a placebo of cabotegravir and active TDF/FTC. Alongside daily administration of oral TDF/FTC for five weeks, participants received intramuscular injections every eight weeks.

On a positive note, women in the cabotegravir group were 89% less likely to contract HIV compared to the group that received TDF/FTC, probably because it is easier to adhere to a treatment that’s taken every 8 weeks compared to a pill that must be taken every day, noted researchers.

But more funding is needed to reach global targets to eliminate HIV, warned another study that was also presented at the conference, and presented by St Luke’s University.

Based on over a hundred nationally-representative datasets representing more than 1.4 million sexually active people, the study projected that the probability of reaching the 2030 targets set by UNAIDS is “very low” – ranging between 0% to 28.5% for HIV testing and 0% to 12.1% for condom use.

Unless more attention is given to the disease, the prospects of reaching these bold targets to put a stop to HIV/AIDS are rather slim, concluded the study.  

Africa Should Not Be left Behind in HIV Prevention & Control 

Along with reviewing new research breakthroughs, members at the Research for Prevention Conference examined the state of HIV prevention and control measures – which highlighted key concerns for the African  continent. 

Phuong Nguyen of St. Luke’s International University presented data analysis that showed African countries are largely not on track to reach key UNAIDS targets for HIV testing and condom use by 2030. 

Trends in oral PrEP use globally as countries introduce and scale up PrEP programs.

Relying on 114 nationally-representative datasets representing more than 1.4 million sexually active people, the team estimated coverage of annual HIV testing and condom use at last higher-risk sex for each country and year to 2030, and the probability of reaching UNAIDS testing and condom use targets of 95% coverage by 2030.

They reported that the probabilities of reaching the 2030 targets were very low for both HIV testing (0% to 28.5%) and condom use (0% to 12.1%). 

Within Africa, they predicted that the countries with the highest coverage of annual HIV testing in 2030 will be Eswatini with 92.6%, Lesotho with 90.5%, and Uganda with 90.5%. The countries with the highest proportion of condom use will be Eswatini with 85%, Lesotho with 75.6%, and Namibia with 75.5%.

The researchers concluded that there is little prospect of reaching global targets for HIV/AIDS elimination. They made the case for more attention to funding and expanding testing and treatment in Africa.

On the brighter side, Africa is making progress on expanding access to existing PreP formulations – and that should accelerate with the new breakthroughs just announced. 

Geographic representation of the number of PrEP initiations globally as of late 2020.

AIDS Vaccine Advocacy Coalition’s (AVAC) Kate Segal noted that sub-Saharan Africa  expanded PrEP access from 4,154 initiations in 2016 to 290,981 by mid-2020, comprising 44% of the global total.

She used data from AVAC’s Global PrEP Tracker to identify global and regional PrEP initiation trends from the third quarter of 2016 through the second quarter of 2020. 

“While PrEP initiations have grown exponentially in several countries, global uptake falls far short of UNAIDS’ target of 3 million users, indicating a need for sustained demand creation where PrEP programs exist, and scale up where PrEP is provided by demonstration projects with limited reach,” the study concluded. 

Find out more about the event here.

Image Credits: Flickr, HIVR4P, Global Advocacy for HIV Prevention.

Doctors putting on N95 respirator masks, face shields, gloves and gowns before entering a COVID-19-positive patient’s room in August in San Diego, US.

In the midst of the spread of new SARS-CoV2 virus variants, several European countries have updated their guidance and regulations on masks, to recommend the use of high-filtration medical-grade masks over fabric ones in confined settings. 

France’s health advisory council (Haute Conseil de la Santé Publique) issued new recommendations last week, warning against the wearing of certain homemade masks due to the insufficient protection provided from the more highly transmissible COVID-19 variants. 

“Artisan masks that you make at home, with the best intentions in the world [and] respecting the official advice, do not necessarily offer all the necessary guarantees,” said French Health Minister, Olivier Véran, in an interview with France Inter. 

Joining Germany and Austria, France appears set to recommend “Category 1” masks, which filter over 90% of particles, for use people are in close contact with others. Category 1 masks includes FFP2 filter masks, or their N95 or KN95 equivalents, as well as single-use surgical masks, and certain fabric masks with high filtration levels, France said.

Fabric masks, included under Category 2, only capture approximately 50% to 60% of all respiratory aerosols. 

A study published in The Lancet in June found that N95 masks and masks with similar levels of filtration are associated with a larger degree of protection from viral infection in comparison to reusable cotton masks. These results were supported by a study conducted by Duke University. 

Surgical masks are three times more effective in preventing droplet transmission than homemade fabric masks, found a 2013 study conducted by Public Health England, a UK governmental health agency. The study advised against the use of homemade masks if a supply of commercial surgical masks is available. 

In light of the data on the degree of mask protection and the more highly contagious variants, “the high council for public health recommends, as do I, that the French do not wear masks they have made at home,” Véran said. 

The recommendation has yet to be enforced and officials are expecting some issues with its implementation. 

German and Austria Have Already Tightened Mask Regulations

Germany and Austria have already tightened mask regulations, mandating the use of medical-grade masks – N95, KN95, FFP2, or surgical masks – on public transportation and in supermarkets. 

“If the virus becomes more dangerous, the mask has to get better,” said Markus Söder, the Minister President of Bavaria, Germany’s largest state and the first to begin implementing the new mandate. 

Production of FFP2 masks is scaling up in Germany, but some experts worry that prices could rise if suppliers are unable to meet the new demand. The government has aimed to provide 15 FFP2 masks to 34.1 million citizens over the age of 60 or with a history of illness by the end of January. 

Health officials in Europe are approaching the new mask guidelines differently. While Germany is requiring FFP2 equivalent masks, French health authorities have discouraged the public from using FFP2 masks, which are high grade fitted masks, because they are difficult to wear correctly.

“In most cases FFP2 masks will be ineffective if they aren’t professionally fitted: people will end up breathing through the gap between the mask and face rather than through the designated filter,” said Jonas Schmidt-Chanasit, a Professor of Arbovirology at the University of Hamburg, in an interview with the Guardian. 

United States Experts Begin Touting “Hi-Fi” Mask Alternatives – But US CDC Yet To Update Guidance 

In parallel to European counterparts, a group of Harvard University experts have also proposed a United States “Hi-Fi” initiative to promote public use of higher quality N-95 or KN-95 masks that can protect more effectively against COVID-19 variants.

As a cheaper alternative, some experts, including US President Joe Biden’s Chief Scientific Advisor Anthony Fauci, are recommending wearing a double mask combination- a surgical mask and a cloth mask, if N95 or FFP2 masks are not available. The combination of two masks, if they fit well, could provide a filtration efficacy rate over 90%. 

Fauci, Director of the National Institute of Allergy and Infectious Diseases, could be seen sporting such a combination at the US President’s Inauguration last week.  He later said that wearing a double mask “likely does” provide more protection. 

“If you have a physical covering with one layer [and] you put another layer on it, it just makes common sense that it likely would be more effective. That’s the reason why you see people either double masking or doing a version of an N95,” Fauci told NBC News on Monday. 

Dr. Anthony Fauci, Director of the National Insitute of Allergy and Infectious Diseases, speaking on COVID-19 virus variants and mask wearing.

Despite increasing moves towards medical-grade masks, the US Centers for Disease Control and Prevention (CDC) has so far stuck to its existing guidelines. The CDC continues to recommend the use of masks made with tightly woven fabrics with two or three layers and discourages the public from using medical masks and N95 respirators in order to reserve them for healthcare personnel. 

WHO Also Sticks to Fabric Masks For General Public

The guidance provided by WHO also continues to recommend only fabric masks for the general public under the age of 60 and without underlying health conditions. It advises the restriction of medical masks to people over age 60, those with certain health conditions, including chronic respiratory disease, cardiovascular disease, cancer, diabetes, and immunocompromised patients, and health care workers.

Image Credits: Flickr – County of San Mateo, Flickr – Navy Medicine, NBC.

While very low-income countries have experienced relatively low mortality rates from COVID-19, they can expect higher mortality caused by the knock-on effects of the pandemic on their fragile health systems, according to the Executive Director of the Global Fund to Fight AIDS, TB and Malaria.

Since the pandemic first overwhelmed health systems in early 2020, countries across the globe have reported a reduction in referrals and diagnoses for various diseases.

Peter Sands, Executive Director of Global Fund

“It’s a perfect storm of concurrent social crises which are disrupting health interventions: programmes to fight diseases like HIV, tuberculosis (TB) and malaria,” Peter Sands, Executive Director of the Global Fund, said during a session of the  World Economic Forum in Davos today.

Last year, India, Indonesia, the Philippines — three high-burden countries for TB — reported a 25-30% drop in its case notifications. A Lancet study predicted a 25% reduction in antimalarial drug coverage in 2020 in malaria-endemic African countries, potentially doubling mortality.

And although the pandemic has affected health systems in low- and high-income countries alike, poorer countries with weaker health infrastructure, greater disease burdens, and generally worse access to COVID-19 treatments and vaccines will have the hardest time recovering.

“Particularly, the lowest income countries have very young populations. This kind of demographic means that the mortality rate from COVID is relatively low,” he said. In the poorest countries, the life expectancy is about 18 years lower than the richest.

But these countries could be more vulnerable to the “collateral damage” of the SARS-CoV-2 pandemic, rather than the direct impact of the virus. 

“You’re going to see relatively low mortality from COVID itself, and relatively high mortality from these knock-on consequences,” added Sands.

Diagnosis Deficit: Lower Diagnoses Globally

The COVID-19 pandemic risks shattering countless disease elimination targets, many of which have been set by the World Health Organization (WHO).

Diagnoses and interventions for communicable and non-communicable diseases (NCDs) have both been impacted in 2020, with COVID-19 and related lockdowns affecting patients’ ability to get access to treatment.

The World Hepatitis Alliance found that last year 94% of respondents in its 32-country survey had had their hepatitis services closed. In addition, half of respondents in lower- and middle-income countries (LMICs) could not get their medication, with respondents in India and Nigeria citing pandemic-related travel restrictions as the cause.

“The Task Force for Global Health and the World Hepatitis Alliance [have] all come up with the same figures,” said Charles Gore, Executive Director of the Medicines Patent Pool.

“Diagnosis and treatment are the key areas in [WHO’s] Global Strategy where the world is lacking,” he added. “And unfortunately, the hit is even bigger in LMICs.”

Where access to treatment for a given disease might have been reduced by 40-60% in a high-income country, “we’re talking 60-90% in LMICs”.

“There’s an estimate that a one-year hiatus in [a country’s] national programs from hepatitis elimination will lead to an extra 45,000 liver cancers and 72,000 deaths by 2030,” he said.

The reduction in access to treatments is similarly stark for NCDs.In the UK, lung cancer referrals in August 2020 were down by 26% from the previous year. During the April lockdown — when much of the Western world experienced its first COVID wave — referrals for lung cancer from doctors’ surgeries dropped by 72%.

“Even if they are referred, it’s very difficult to get patients through the system, and get respiratory symptoms investigated so they can start treatments quickly,” said Michelle Mitchell, chief executive of Cancer Research UK.

“This is a time of great worry for patients with lung cancer or other types of cancer.”

Patients will have a much better prognosis if they are diagnosed early. Data observed by Cancer Research UK indicates that nearly 90% of patients diagnosed at Stage 1 survived the disease for at least one year, compared to just 19% for those diagnosed at Stage 4.

“It’s too early to know the impact yet,” she said. “But we do expect there to be a huge impact.”

Build Back Better: ‘Not Ambitious Enough’

The process of ‘building back better’ does not go far enough, Harvard T.H. Chan School of Public Health’s Dean, Michelle Williams, said.

Building back better refers to a process of economic recovery from COVID-19 that avoids destructive investment patterns: namely, investments that endanger biodiversity, which is linked to zoonotic diseases jumping species.

“What COVID has done is really show how weak global public health infrastructure can bring us to our knees,” she said.

“To build back better is [to] first recognise the importance and value of public health and invest accordingly. That means properly investing in global governance of public health leadership [and] making the structure nimble and equipped.”

An interim report by the Independent Panel on Pandemic Preparedness and Response, published last week, determined that WHO’s COVID-19 response was too slow, and was hampered by a lack of resources and a damning lack of authority among its member states.

“We’re not being remotely ambitious enough,” Sands said. “This year we are deploying about US$4.7 billion on HIV, TB and malaria to mitigate the collateral damage … we need another $5 billion. And that’s the Global Fund alone.”

And the global ambition for economic recovery, which is “currently shaped as getting back to [a] pre-pandemic” scenario, is “not good enough”, Mitchell added. “Because we weren’t doing well enough before COVID.”

Image Credits: The Global Fund.

WHO is yet to grant the Moderna vaccine Emergency Use Listing (EUL), but its advice for use is still significant as many member states rely upon these vaccine recommendations as a global reference point.

The Moderna COVID-19 vaccine is safe for most people including those with a wide range of underlying medical conditions, according to the World Health Organization’s Strategic Advisory Group of Experts (SAGE) on immunizations.

However, the vaccine is not recommended for pregnant women or children as it has not been tested on these groups, according to interim recommendations published today by WHO.  The issue of the vaccine in pregnancy is emerging as a bigger issue in light of recent evidence, including from the US Centers for Disease Control, that pregnant women are at higher risk of serious COVID-19, and as new variants of the SARS-CoV2 virus infect more young people, including those of childbearing age.

The WHO approval may also pave the way for Moderna to contribute vaccines to the global COVAX facility, following a final WHO “Emergency Use Listing” approval for the vaccine.

Last Friday, Pfizer announced it was contributing 40 million doses of its vaccine to the WHO co-sponsored COVAX, weeks after WHO approved the vaccine.

People who have severe allergic reactions to any of the vaccine’s components should not receive it, and it should also not be used in countries that do not have the capacity to treat anaphylactic shock, according to SAGE. It also advises caution about administering the vaccine to frail, elderly people near the end of their lives.

The vaccine needs to be administered in two doses 28 days apart, although “the interval between the doses may be extended to 42 days”, SAGE said. All those vaccinated should be observed for “at least 15 minutes after vaccination”, and anyone experiencing an immediate severe allergic reaction should not receive the additional dose.

No Word On Emergency Authorization From WHO

The WHO has not yet issued an Emergency Use Listing (EUL) for the Moderna vaccine, but it has undergone review by the European Medical Agency (EMA), which has authorized its use in the European Union. It has also been approved in the United States, Canada, the United Kingdom and Swissmedic.

Regardless, the WHO advice is significant as many member states – especially low- and middle-income countries (LMICs) – also rely upon WHO for vaccine recommendations as a global reference point.

Dr Kate O’Brien, WHO’s Director of Vaccines, told a media briefing today that the global body was still in discussions with Moderna about the information it needed to issue an EUL, and so did not comment about if or when this would be issued.

O’Brien did add, however, that SAGE’s advice was important as some member states had already made arrangements to procure the vaccine from Moderna.

Dr Kate O’Brien, WHO’s Director of Vaccines.

Moderna and Pfizer/BioNTech are both mRNA-based vaccines, but the Moderna vaccine does not need to be stored at the extremely cold temperatures required by the BioNTech-Pfizer vaccine, which makes it more suitable for LMICs.

In trials, the Moderna vaccine showed an efficacy of approximately 92% in protecting against COVID-19, starting 14 days after the first dose.

Moderna claimed yesterday that its candidate appears to retain its efficacy against the B.1.1.7 and South Africa-identified (B.1.351) variants. In the study, which is yet to be peer-reviewed, researchers looked at blood samples from eight participants who had previously received the recommended two doses during Phase 1 trials.

In the case of the B.1.1.7 variant, they reported the mutated virus posed no significant impact on titers: a means for measuring the amount of antibodies in a blood sample. Tests on B.1.351 showed a “six-fold reduction in neutralizing titers” although “neutralizing titer levels with B.1.351 remain above levels that are expected to be protective”, according to the company media release.

Meanwhile, Moderna also announced that it will “test an additional booster dose of its COVID-19 Vaccine (mRNA-1273)” to see whether it can further increase neutralizing antibodies against emerging strains “beyond the existing primary vaccination series”.

Despite this, O’Brien said that clinical evidence was needed to support this report, and that the blood sera of people who have antibodies against COVID-19 was currently being tested against these variants.

She welcomed how prepared vaccine manufacturers were to “potentially make modifications to the vaccines that they are continuing to develop”.

“The preponderance of evidence at hand, albeit small, is that the vaccines in hand are extremely valuable as part of the toolbox for fighting the pandemic and really crushing this virus, but we will continue to respond to as new scientific evidence comes in,” concluded O’Brien.

Image Credits: Moderna.

Without this fund, the world’s poorest countries would have to pay out legal claims made by people who might suffer serious side-effects after receiving their COVID-19 vaccination.

The global COVID-19 vaccine access platform, COVAX, plans to impose a US 10-cent levy on each vaccine dose to fund a compensation scheme for people who suffer from severe adverse reactions to any of the vaccines it supplies.

The “no-fault” compensation fund is crucial for countries who join COVAX, as one of the conditions of membership is that they agree to indemnify pharmaceutical manufacturers from any legal claims from people who might suffer serious side-effects.

Without the fund, the world’s poorest countries – defined as COVAX’s advance market commitment (AMC) countries – would have to pay out citizens’ claims themselves.

In the past two weeks, the US Centers for Disease Control and Prevention (CDC) reported several cases of people suffering from anaphylactic shock as a result of taking the Pfizer-BioNTech and Moderna vaccines. Anaphylaxis is a severe, life-threatening allergic reaction that occurs rarely after vaccination, according to the CDC.

In the case of the Pfizer-BioNTech vaccine in the US, by 23 December, some 4,393 adverse events had been reported out of 1,893,360 (0.2%). Of these, 21 cases were determined to be anaphylaxis (a rate of 11.1 per million doses administered), including 17 in persons with a history of allergies or allergic reactions.

In Moderna’s case, by 19 December, 4,041,396 first doses of Moderna COVID-19 vaccine had been administered in the US, with 1,266 adverse events reported (0.03%). Of these, 10 cases were determined to be anaphylaxis, nine of whom had a history of allergies or allergic reactions.

COVAX published an indemnification proposal in November, which states that “each country receiving COVID-19 Vaccines through the COVAX Facility, whether distributed under an emergency use authorization or recently licensed, will be required to indemnify manufacturers, donors, distributors, and other stakeholders against any losses they incur from the deployment and use of those vaccines”.

A spokesperson for GAVI, the Vaccine Alliance, which manages COVAX, told Health Policy Watch that the facility had been working with all stakeholders to establish “a comprehensive solution addressing the need for indemnification and the financial obligations this may impose on middle- and low-income countries”.

The compensation fund will be financed “from a $0.10 per dose levy charged by GAVI on the doses to be distributed to AMC countries through the COVAX Facility,” said the spokesperson. “We will be announcing more details, including specific terms around the principles governing indemnity, in the coming days.”

COVAX has also facilitated a common template agreement for AMC-eligible economies, that has been negotiated with, and agreed upon by all manufacturers which will “greatly reduce the legal burden on AMC participants”.

All Medicines Contain ‘Some Risk’ But Not An Excuse For Sub-Par Product, Experts Remind

Professor Brook Baker, an access to medicines expert at Northeastern University in Boston, said that “there are credible arguments for some degree of indemnification, but it should not be a blanket indemnification for harms caused by manufacturer neglect”.

“All medicines contain some risk of known and unanticipated adverse side effects or reduced efficacy. The risks of vaccines in particular are considered significant, not because vaccines don’t meet heightened safety requirements, but because they are given to large populations of otherwise healthy people,” explained Baker.

“Some risks of vaccine administration are unavoidable. Most of them are rare and listed, but others may be truly rare and unexpected. It makes some sense for governments and payers to indemnify against these predictable and inevitable risks – otherwise vaccine manufacturers might charge much higher prices or avoid vaccine R&D and sales altogether,” added Baker.

However, he said manufacturers should not have a “free pass” against adverse outcomes that they could have prevented, such as a sub-standard batch of vaccines or if the manufacturer failed to monitor and report significant side-effects adversely affected particular populations.

COVAX is also proposing a “no-fault, lump-sum compensation” for an adverse event as a “full and final settlement of any claims”, but this won’t preclude a local claim.

However, Baker cautioned that “a lot of people suffer health effects after vaccination that are not causally related to the vaccine – there is correlation but not causation”.

For this reason, some no-fault schemes “get hung up on long, drawn-out investigations of causation”, making the compensation process slow.

In addition, “no-fault compensation schemes can be overly bureaucratic and costly to maintain and administer”, warned Baker. “Resource poor countries with weak regulatory capacity would have particular difficulty setting up and running a no-fault compensation mechanism at the national level.”

Image Credits: CIO Look/Flickr, Bret Bostock/Flickr.

Dr Tedros Adhanom Ghebreyesus, WHO Director General, at Monday’s Executive Board session.

COVID-19 has led to the suspension of polio campaigns in more than 30 countries, and has underscored the importance of the mission to eradicate it, tackle antimicrobial resistance, and ensure the timely sharing of pathogens, said WHO member states at Monday’s Executive Board session. 

Throughout the morning and afternoon sessions, member states reviewed and discussed the Director General’s reports on poliomyelitis eradication, polio transition planning, antimicrobial resistance (AMR), and the public health implications of the implementation of the Nagoya Protocol. 

Afghanistan and Pakistan have already reported outbreaks of both types of polioviruses, making them the last two remaining polio endemic countries. Although polio outbreaks impacted three of WHO’s six regions in 2020, with almost 1,000 cases recorded, 30% of the emergencies were stopped during the year, demonstrating the ability to stop polio outbreaks even in the midst of a pandemic. The pandemic has also disrupted routine immunisation programmes, increasing outbreaks of both wild and vaccine-derived polioviruses.

“Polio is still considered an emergency, and rightly so, because it could become a major international problem again if we’re not careful,” said WHO Regional Director for the Eastern Mediterranean, Ahmed Al-Mandhari. “So we need the resources that are required to keep the public health situation under control and make sure that all countries of our region are doing what needs to be done as it needs to be done.

“This requires resource mobilisation across the region…We’ve got children at risk of being paralysed for life and we must save them from that. That means intensifying our efforts as we get close to the finishing line of efforts to eradicate poliomyelitis.” 

Despite the disruptions of efforts to combat vaccine-preventable diseases, along with projections that the African region could see a 200% increase in the number of districts with polio cases by the end of 2020, WHO officials highlighted the opportunities brought along by the SARS-CoV2 virus. This could particularly be the case for polio transition, which is the adaptation of polio infrastructure for disease surveillance, social mobilisation, vaccine delivery, and care for hard-to-reach populations to other programme areas. 

“Firstly, COVID-19 is accelerating programmatic integration…We are now leveraging the full technical expertise to align polio transition activities with other programmatic priorities and the planning processes,” said Zsuzsanna Jakab, WHO Deputy Director-General. “Secondly, COVID-19 has once again demonstrated the value of the polio network, especially at the community level…Thirdly, COVID-19 underlines the importance and the need for strong and resilient health systems. In countries where there is a strong polio footprint, the polio network is a core component of the essential public health workforce.”

Zsuzsanna Jakab, WHO Deputy Director-General.

The contributions of polio staff, networks, resources and expertise to COVID-19 actions assisted in the pandemic responses in over 50 countries. In the African region, two polio personnel at the national and district levels in country offices in the region are spending more than half of their time on the COVID-19 response. 

In addition, “polio colleagues are the main frontline workers [in the African region] responding to outbreaks of cholera, yellow fever, and meningitis,” said Matshidiso Moeti, WHO Regional Director for the African Region. 

Australia’s delegation echoed some of WHO’s messages, “acknowledg[ing] the ongoing role the GPEI [Global Polio Eradication Initiative] will have in supporting the delivery of COVID-19 health interventions, including vaccinations.”

Polio Eradication Efforts Face “Precarious Financing”

Meanwhile, member states expressed concern regarding the “precarious financing situation” of the Global Polio Eradication Initiative, a public-private partnership with six core partners – WHO, Rotary International, the US Centers for Disease Control and Prevention, UNICEF, the Gates Foundation, and GAVI. 

“We’re concerned at the slow pace with which polio transition plans are being finalised. Given current funding constraints, this work needs to be expedited now more than ever,” said the UK’s delegate. 

“We share concern with regard to the financial gap in GPEI’s budget this year. The way forward is looking for new financial resources, but also focusing on increasing efficiency,” said the delegate representing Germany. 

Burkina Faso, speaking on behalf of the 47 WHO member states of the African region, called upon stakeholders to strengthen the financial mechanisms to fight polio, particularly given the “fragile financial situation.”

Burkina Faso’s delegate at the Executive Board session on Monday.

With the announcement in the Director General’s report of the likely scaling back of resources and presence in countries where poliomyelitis is not endemic, the African region emphasised the need to “mobilise long term financing to allow the region to continue its elimination activities” and “ask[ed] WHO to add financing for poliomyelitis and put it in one of the priorities of the program budget for 2022-2023 and following budgets,” said Burkina Faso’s delegate. 

In an effort to reassure member states, Jakab recognised the need for long term financing to sustain polio assets. “We would like to assure [member states] that this remains a priority for WHO’s programme budget 2020-2023 and beyond.”

“The draft budget presented to the EB reflects our commitment to sustainable financing for the polio network and we are working closely with GPEI and other development partners to develop comprehensive resource mobilisation efforts for future financing,” she added. 

“I encourage partners and donors to continue to support WHO in order to sustain our core functions where polio infrastructure can make the most impact,” said Dr Tedros Adhanom Ghebreyesus, WHO Director General. “These functions are central to reaching the 13th General Programme of Work (GPW) goals of promoting health, keeping the world safe and serving the vulnerable.” 

Antimicrobial Resistance

Also on the Executive Board agenda was AMR, a growing global threat. Essential antimicrobial drugs used to treat common infections are becoming ineffective globally, but the highest rates of resistance are in low- and lower-middle-income countries, found WHO’s progress report on the implementation of the Global Action Plan on Antimicrobial Resistance. 

A risk assessment conducted by the Secretariat indicated that COVID-19 has disrupted planned and ongoing national AMR activities and has heightened the risk of resistance emerging due to the irrational use of antimicrobials to treat patients infected with SARS-CoV2. 

The EU and the Philippines laid out the interplay between COVID-19 and AMR, which included supply chain disruptions of antibiotics, interruptions in the delivery of routine immunisation services, and the misuse and overuse of antibiotics in managing COVID-19 patients. 

“These developments, if not addressed, can push back all the gains in our fight against infectious diseases,” said the delegate representing the Philippines. 

Philippines’ delegate at the Executive Board session on Monday.

“Within the context of the pandemic, implementing the relevant programmes to mitigate and control AMR, such as infection prevention, surveillance, antimicrobial stewardship, and WASH [water, sanitation, and hygiene] have become even more crucial,” said Dr Tedros. “As we continue to tackle the COVID-19 pandemic, we must simultaneously ensure that efforts to stop the spread of AMR are accelerated to control this silent tsunami together.” 

WHO Collaboration to Address AMR

Following the establishment of the Tripartite Joint Secretariat on AMR, a collaboration between WHO, the Food and Agriculture Organisation (FAO), and the World Organisation for Animal Health (OIE), the tripartite Antimicrobial Resistance Multi-Partner Trust Fund was launched in 2019 to support One Health action in low- and lower-middle-income countries.

“In Brazil’s view, the collaboration between WHO and other agencies within the United Nations system [such as through the Tripartite Joint Secretariat on AMR] will be as legitimate and successful as they perform their respective mandates and are accountable to their respective governing bodies,” said Brazil’s delegation. “We also see room for improvements in the way that AMR-related high level bodies connect their work, the wealth of needs and context to member states.”

The Trust Fund was supported by Zambia at the Executive Board session, as “this will ensure sufficient and sustainable AMR funding” through the utilization of multi-fund streams. 

“134 countries have established national plans [on AMR], but a lot of countries lack the necessary financing. As a result, plans won’t have a real impact. We can’t be successful if we don’t have the necessary financing in place to implement activities at the national, regional and local level,” said Professor Hanan H. Balkhy, WHO Assistant Director-General of Antimicrobial Resistance. 

Professor Hanan H. Balkhy, WHO Assistant Director-General of Antimicrobial Resistance.

“We call upon all member states to take the necessary measures to fight AMR by establishing these national action plans and establishing the financing so that they can be implemented in the context of Universal Health Coverage and primary health care,” she added. 

WHO and member states agree upon the need for a holistic and multi-sectoral approach – a One Health approach – to AMR and several announced their support for the One Health Global Leaders Group on Antimicrobial Resistance, a key global governance structure comprised of members states, civil society and the private sector. 

“We applaud the many initiatives that are putting the one health approach in practice at the global level….Germany welcomes the recent establishment of the One Health Leaders Group and is happy to be represented in this group,” said Germany’s delegate. “We trust that it will keep AMR high on the political agenda.”

Mechanisms for Pathogen Sharing in Health Emergencies

Subsequently, member state discussions on practices in the sharing of pathogens and genetic sequencing data commenced, largely focusing on actions taken in relation to the SARS-CoV2 virus and highlighting the importance of rapid pathogen sharing in the context of public health emergencies.

Austria, speaking on behalf of EU member states, underscored the “confusing situation” and legal uncertainty that surrounds the timely access to pathogens in health emergencies. This uncertainty “could cause delays in access to diagnostics, therapeutics and vaccines,” said the Austrian delegate.

Ambassador Elisabeth Tichy-Fisslberger, Permanent Representative of Austria to the United Nations Office at Geneva.

Current arrangements lack clarity, as the distinction between the sharing of biological pathogen samples and genetic sequences is blurry and the implementation of certain provisions of the Nagoya Protocol – an international legal agreement on the fair and equitable sharing of genetic resources – is limited, according to the Austrian delegation.

By contrast, India’s delegate recounted the benefits of the Protocol revealed by the pandemic. “[The Nagoya Protocol] facilitated the rapid sharing of information about the COVID-19 virus and helped in establishing a systematic, organised method of data exchange to prevent any potential breaches in the country’s jurisdiction related to sharing and use of biological data and resources,” said the delegate representing India.

The Chinese delegation recognised the urgent need to establish a fair and equitable benefit sharing mechanism and highlighted China’s efforts to fulfill its obligations to promote access to genetic data under the Nagoya Protocol.

Both China and the US delegations drew attention to the actions of their respective countries during COVID-19.

“Concerning the sharing of the SARS-CoV2 virus, since the outbreak, China immediately mobilised high level, biological security labs with leading experts to conduct a parallel testing for cases and samples. Within a record breaking time period, they identified SARS-CoV2 as the pathogen and immediately shared this genome sequencing,” said China’s delegate.

China’s WHO Executive Board delegate at the session on Monday.

“The genome sequencing shared immediately by China provided the world with important basic information to be used in clinical diagnostics,…vaccine research, origin tracing, [and] virus evolution studies,” he added.

In the US, “the National Institute of Allergy and Infectious Diseases has shared these [SARS-CoV2 virus samples] more than 4,500 times…with diverse stakeholders in at least 49 countries, including government scientists, academics, and private sector companies for any legitimate purpose required to study, rapidly detect, prepare for, and respond to COVID-19,” said the delegate from the US.

The discussion on pathogen sharing practices and pathways to increase the capacity for the sequencing and analysis of genomes globally will resume on Tuesday, prior to the closure of the 148th session of the Executive Board.

Image Credits: WHO / Christopher Black, WHO.

Björn Kümmel, Vice Chair, WHO Executive Board.

Discussions on WHO’s state of financing were addressed by member states during the on-going Executive Board meeting. As we reported last week, WHO is keen on defining independence and sustainability of its financing to be better prepared to address emergencies in the future.

We spoke to Björn Kümmel, Deputy Head of Unit, Global Health, German Federal Ministry of Health and Vice Chair of the WHO Executive Board, who has been actively involved consistently in raising these issues on the organization’s finances. He was also a part of the consultations on the Open-ended Intergovernmental Working Group on Sustainable Financing at the EB last week.

Geneva Health Files: Germany has emphasized the importance of assessed contributions for improving the finances of WHO. Can you please share your reasoning behind an increase in assessed contributions for all member states?

Björn Kümmel: Strengthening of the World Health Organization (WHO) is a key priority for the German Federal Government. In the new Global Health Strategy of the German Federal Government, which has been adopted by the Cabinet of Ministers last October, there is a clear focus on enabling WHO to play its mandated role as the leading and coordinating authority in global health.

The WHO’s budget has grown over the past decades. However, the assessed contributions have remained practically stable since the year 2000. Today, WHO’s overall budget volume foresees roughly 5 billion USD for two years. While in past history, the entirety of the membership fee, the assessed contributions was the main part of WHO’s budget, since 2000, the voluntary contributions have outgrown the assessed contributions.

It is essential to realize, that today, the vast majority of  financial resources (currently roughly 83 %) are contributed on a voluntary and largely unpredictable basis. These funds are provided and steered by a very limited number of generous individual donors on a purely voluntary basis. These donors decide, for which concrete goals WHO may use the funding, and they are free to withdraw the funding as they please. This financial dependency on a very limited number of key donors is seen as one of the key risks for WHO as this leads also to political dependency. Some argue that WHO is often used by donors like an implementing agency, implementing the goals that are a priority for the generous donors.

With only 17 % purely predictable and flexible sustainable finances (assessed contributions), it is practically impossible for WHO to play its envisaged role as a guardian of global health. Through the COVID-19 pandemic it has become obvious: The expectations of the 194 Member States vis-à-vis WHO by far outweigh WHO’s de facto abilities. And while in the WHO governing bodies, Member States keep on adding concrete tasks for WHO, not only but including through adopting World Health Assembly Resolutions that have wide financial implications, within the past decades, the WHO Member States have failed to properly address the key challenge of sustainable financing for WHO. One lesson that will most likely be pointed out in the current lessons-learnt-processes that assess the reaction towards the COVID-19 pandemic will be: This financing challenge needs to be tackled if  WHO should in the future continue to be expected to lead and coordinate the international prevention, detection and response to pandemics.

GHF: Based on the deliberations at the EB, what is your assessment of WHO’s proposal for sustainable financing?

Björn Kümmel: Through its resumed session in November 2020, the World Health Assembly has asked the WHO Secretariat to prepare a paper on sustainable financing for discussion at the Board`s meeting in January. The Secretariat’s report (EB148/26) provides a clear picture about the different sources of financing for WHO with regards to the question whether this financing is sustainable or not. The Secretariat proposed to set up a Member State working group to assess the situation with regards to the sustainability of financing for WHO. Based on this assessment, the working group is supposed to discuss and explore options in order to address this challenge. However, it is clear, that it is not the role of the working group to take final decisions. These would have to be taken by the entire membership of WHO, all 194 Member States together.

The proposed process is promising as it may help to address one of the key structural challenges that has been hindering WHO to fulfil its mandate. During the yearly meetings of the Executive Board in January, the implementation of the current Programme Budget is being discussed. In the relevant discussions, all Member States complain about the fact, that the different programme areas of the WHO are unevenly financed with many so called “pockets of poverty”. These are predominant throughout all WHO’s programme areas and have severe implications for WHO’s day to day work.

It is important to understand: When WHO’s programme budget is being approved by the 194 Member States, it is a largely unfunded budget. The only financing source that is purely certain is the 17 % share of the assessed contributions and some already secured grant agreements by voluntary donors. Therefore, WHO has to raise the vast majority of the needed finances after the approval of the programme budget.

This has led to the fact, that many departments need to spend major parts of their work on fund-raising efforts to make sure that envisaged activities are enabled and staff positions can be paid for. Since the vast majority of WHO’s funding is unpredictable and non-sustainable, many WHO staff members do not work on a long-term basis but even based on contracts covering shorter periods than half a year. In addition, this situation has led to a major increase of the use of “non-staff” contracts, in particular consultants and other agreements that are perceived to be more flexible and cover shorter periods of time. Obviously, this financial reality is hardly reconcilable with the need to ensure the best talent in public and global health in order to be able to lead global health by excellence. Attracting and retaining the needed talents will be a growing challenge due to the human resources consequences of the current financing model of WHO.

The discussion that will evolve based on the Secretariat’s report on sustainable financing and the future work of the working group is of highest importance to make all WHO Member States and the broader public health community aware of this financing challenge. We hope that the different ways that have been tried in the past years to ease this challenge will be assessed including why these options have failed to properly address the given challenge. It would be a great step forward, if, through this process, the WHO’s governing bodies would devote adequate focus on potential future options for long-term solutions.

It is clear, that this will be a lengthy and very complex endeavour. However, the COVID-19 crisis may serve for a new political understanding among the entire membership of WHO, that more sustainable investments are needed to enable WHO to fulfil its mandated role.

GHF: What steps have been taken, or will be taken, in the near future to revitalise the role of the governing bodies?

Björn Kümmel: Germany has been a member of the Executive Board for the past three years. From the start, we shared the view that the role of the governing bodies and in particular the Executive Board indeed needs to be revitalized. The Executive Board has been criticized not to allow for adequate interaction between its members and sometimes not being able to more flexibly shift the focus of its deliberations on the most pressing and decisive questions. It is a fact, that the Executive Board has become to some extent a small World Health Assembly.

While this transparency is a great merit as it allows for full inclusiveness and at least theoretically ensures that the Assembly is well prepared through a consensual process, some argue that this setting sometimes limits the interaction in between the original members of the Executive Board. This leads to reading out only prepared statements and thus reduces the role of the Executive Board to serve as an exclusive steering board.

During the COVID-19 pandemic, some EB members have raised their concern, that the EB has not played its mandated role to provide oversight and guide the work of the Secretariat throughout the pandemic. In order to reflect on this and more generally the role that the Executive Board sees for itself, a retreat of the Executive Board has been proposed. Taking into account the limitations for such a retreat during the ongoing pandemic, members of the Executive Board have called for such a retreat at the earliest possible timing.

Priti Patnaik is the founding editor of Geneva Health Files – a reporting initiative that tracks power and politics in global health.

This interview is a part of a series under a new collaboration arrangement between Geneva Health Files and Health Policy Watch.  

Image Credits: C Black, WHO.