Heiner Wedmeyer reports on Bulevirtide to treat and even cure Hepatitis D, with Maria Buti, EASL Public Health Chair and EASL Secretary General Thomas Berg,

The drug Bulevirtide can successfully treat and even potentially cure Hepatitis D – the most acute diseases of the hepatitis family and hardest to treat until now, according to the results of a Phase III trial of the drug announced on Thursday, the opening day of the International Liver Congress 2022 (ILC 2022). 

An estimated 12 million people worldwide have experienced HDV infection, also known as Chronic Hepatitis Delta. HDV is found in up to 5% of people worldwide living with Hepatitis B (HBV). HBV also has so far eluded a cure. But promising clinical trial results of other new drugs and drug combinations to treat HBV, and related to that, acute hepatic porphyria, also being discussed at the conference, could help advance that goal. 

“With Bulevirtide, an inhibitor of HBV and HDV entry into liver cells, we can for the first time successfully treat Hepatitis D,”  said EASL in a press statement.  Results from 48 weeks of treatment with the drug also showed HDV RNA at undetectable levels in a significant proportion of those treated, leading to hopes that the treatment could also lead to a cure.  

“This is almost a historic moment for heptatology,” said principle investigator, Heiner Wedemeyer, of Germany’s Hannover Medical School, of the findings. He speaking at an ILC press briefing about the Phase 3 trial,  undertaken in Germany, The Russian Federation, Italy and Sweden of 2 and 10 mg doses of the drug daily for a period of 48 weeks. “For us in the Hepatitis D field, this is really exciting times, completely novel data, and game-changing for treatments.”

Results of randomized, Phase 3 study of 2 mg or 10 mg dose of Bulevirtide in patients with HDV virus in four European countries, as presented at the International Liver Conference 23-26 June, 2022

Convened by the European Association for the Study of the Liver (EASL) in a hybrid format, the conference in London, 23-26 June saw 5,000 scientists, doctors, public health officials, and patient groups attending in-person for the first time since the beginning of the COVID pandemic. 

Other advances being discussed at the conference will include: new treatments for reducing liver fat and positive results from the largest human trial of preemptive drugs administered before transplantation of a hepatitis C compromised organ, which can fully protect a patient from risk associated with post operative infection.

“We may well be entering into a new golden age of hepatology science,” said Thomas Berg, Secretary-General of EASL and Head of the Division of Hepatology at Leipzig University Medical Center in Germany. “There is respite coming for those people living with Hepatitis D and we are making progress towards finding a cure for Hepatitis B which affects millions people around the world. The science is inching us towards a potential public health revolution.”

Event takes place against backdrop of increased liver disease 

This year’s EASL takes place against the backdrop of an increased prevalence of liver disease across the globe.

In Europe, chronic liver disease has a substantial impact on young and middle-aged individuals in their prime working years, with the peak age of death occurring in the late 40s and early 50s. Liver disease is now the biggest killer of 35–49-year-olds in the United Kingdom. 

This contrasts with mortality from smoking-related and other obesity-related illnesses, such as lung cancer or type 2 diabetes, for which deaths typically occur in the 60s and 70s. Consequently, data from the World Health Organization shows that liver disease is now second only to ischemic heart disease as the leading cause of years of working life lost in Europe. On average, two-thirds of all potential years of life lost due to mortality from liver diseases are years of working life.

New treatments for Non-Alcoholic Fatty Liver Disease (NAFLD) 

The Congress also will see reports on the results of the human trial of a new drug Pemvidutide with the potential to reduce both weight and liver fat; as well as results of a randomized-controlled trial on a low carbohydrate/high fat diet, and its potential impact on fatty liver disease.

The search for new treatments for Non-Alcoholic Fatty Liver Disease (NAFLD) has gained momentum over the past few years as countries worldwide grapple with a rise in the disease, just one  result of the worldwide increase in obesity levels. NAFLD is now the fastest growing disease in the world, and the most common cause of liver disease in many developed countries.  

In a proportion of people, NAFLD can cause progressive liver damage, and in some cases it may even lead to the development of liver cirrhosis and liver cancer. In the U.S. it is now the most common indication for a liver transplant, according to EASL.

It is estimated that if left unchecked, the annual predicted cost of NAFLD in Europe is estimated to be greater than €35 billion in direct costs to the health system, and a further €200 billion by way of wider costs to society.

–Updated 27 June 2022

Image Credits: Wedemeyer et al, EASL2022 presentation.

A man with symptoms of trypanosomiasis, a neglected tropical disease, is examined by Dr Victor Kande in the Democratic Republic of Congo (DRC).

The Kigali Summit has called for the renewal of commitments in the fight against neglected tropical diseases (NTDs) through the adoption of the Kigali Declaration on NTDs. 

Sponsored by the government of Rwanda, the Kigali Declaration on NTD is the successor to the ground-breaking London Declaration of 2012, which was a pledge made by governments, donors, pharma, research institutions, NGOs, and other stakeholders to collaborate in their efforts to stop NTDs. 

The new Kigali Declaration aims to mobilize political will and secure commitments to achieve the Sustainable Development Goal target on NTDs and to deliver the targets set out in the World Health Organization’s Tropical Disease Roadmap (2021 – 2030).

The summit, hosted on Thursday by President Paul Kagame of Rwanda and co-convened by The RBM Partnership to End Malaria and Uniting to Combat NTDs, builds on progress made in the last two decades, and even more so since the London Declaration, to galvanize action to end malaria and NTDs. 

The summit is also a critical moment to highlight how investments in fighting both malaria and NTDs have a much broader impact, and increased investments will strengthen health systems and protect against future pandemics. 

In conjunction with the summit, Swiss pharmaceutical company Novartis has endorsed the new declaration and has announced a $250 m five-year commitment in the fight against NTDs.

“Today, by endorsing the Kigali Declaration and pledging to invest USD 250 million, we aim to accelerate  progress toward elimination of these diseases, which continue to cause suffering and stigma  for millions of people around the globe, ” said Novartis CEO Vas Narasimhan.  

Ending NTDs is possible 

Ambitious global commitments over the years have shown that ending NTDs is an achievable goal, with 45 countries eliminating at least one NTD, 600 million people no longer requiring treatment for NTDs, and cases of diseases that have plagued humanity for centuries, such as sleeping sickness and Guinea worm disease, at an all-time low.

However, 1.7 billion people continue to suffer from NTDs, and 241 million people are impacted by malaria globally. 

Additionally, according to the annual G-FINDER report, funding for NTDs remained relatively stagnant, with only snakebite envenoming seeing increased investment in 2020. 

Novartis’ $250 million commitment will be used to advance research and development of new treatments to combat NTDs and malaria.  It includes $1 million to advance R&D, focusing on novel drug candidates for four diseases: Chagas disease, visceral leishmaniasis, dengue fever, and Cryptosporidium. 

Some $150 million will be invested to advance the clinical development of three drug candidates to combat emerging resistance to artemisinin, a well-established treatment for malaria.  

With both its adoption of the Kigali Declaration and this new investment, Novartis reiterated its commitment to the fight against NTDs and malaria.

“Over the past decade, great progress has been made against NTDs, but there is still a lot more work to be done. Novartis will continue progressing our longstanding commitment to helping realize a world free of NTDs,” said Narasimhan.

Image Credits: DNDi.

The Global Health Matters podcast with host Garry Aslanyan.

It was 11 November 2022 when Dr Sikhulile Moyo and his team of scientists in Botswana discovered Omicron in a sample of SARS-CoV2 that looked different from the rest. 

“We sent it back to the lab to have it re-sequenced,” Moyo recalled. But by 19 November, the team was confident about what they had found. Two days later they reported what became known as the Omicron variant to the World Health Organization (WHO).

Moyo’s work raised a red flag for countries around the world. Even today, Omicron and its offspring remain the most dominant COVID-19 strain in circulation. 

PLAY PODCAST

Moyo discovered the Omicron variant in Botswana through careful cross-examination of COVID-19 tests – which is the topic of the most recent Global Health Matters podcast with host Garry Aslanyan.

Garry has two guests with a deep understanding of diagnostics and their application worldwide: Sikhulile Moyo, the research laboratory director at the Botswana Harvard AIDS Institute Partnership; and Bill Rodriguez, the CEO of FIND, the global alliance for diagnostics, and the founder of his own diagnostics company, Daktari Diagnostics.

The COVID-19 pandemic has brought a new global awareness of the need for accessibility to diagnostics in order to protect people. In this episode, the guests help Aslanyan answer questions such as “how available are essential diagnostics in low- and middle-income countries (LMICs)?” They also help listeners better understand the state of diagnostic testing in LMICs and how to achieve equity in access to testing in all countries.

Moyo was able to sound the alarm on Omicron because Botswana had put a good testing system in place, meaning the discovery of Omicron was not an accident but the result of a strategic and intentional increase in diagnostics in the region.

“Botswana decided to make sure there was access testing to all districts by identifying ‘COVID zones,’ Moyo explained. “Each of these areas had a PCR lab and we used the infrastructure from HIV to develop a surveillance strategy that could be built on that. When someone tested positive, we could investigate it.”

The surveillance team genetically sequenced samples from entry points into the country and hospitals – both people who developed severe disease and those who died of the virus.

With regards to the general population, while not everyone could be sequenced, they aimed to conduct a representative sampling.

“Because we were sequencing weekly, we caught those Omicron samples in our batch,” Moyo said.

The scientists noticed that the variant appeared to be an unusual lineage, though they could not have known it would become a variant of concern (VOC). However, on reporting it, they learned that other labs had discovered something similar. Then, on 26 November WHO named it at VOC and gave it the name Omicron. Moyo said he is saving and is going to frame that email to WHO because it changed the world.

“For me, I was fulfilled as a scientist to report something like that,” Moyo said. “But it was also a rollercoaster of emotions because of the way the world reacted with travel bans. I think we learned a lot over the past two years and that reaction was unfortunate.”

COVID highlighted the need for diagnostics manufacturing facilities in the Global South

Pandemics, according to Rodriguez, reveal all the existing problems in society. COVID-19 has highlighted the failure to invest in community-based diagnostics and revealed major gaps between the Global North and Global South in terms of equipment, manufacturing and qualified staffing.

“You may not remember, but two years ago, we became acutely aware of how important testing was and how little access we had to it anywhere in the world – for sure in low- and middle-income countries, but even in higher-income countries,” Rodriguez recalled.

“Now people understand it is a critical part of our health system and we need to make sure it is available,” he continued. “Equity in testing became a cornerstone of the global response to COVID.”

He said it highlighted the need to have a leader, like WHO, to deliver the message that testing was critical, but it also called to the forefront the need to establish diagnostic manufacturing facilities in the Global South.

“The factories that made the test kits were mostly in the Global North and that created problems and made a lot of countries realize how dependent they are,” he said.

Over the past 18 months, efforts have been made to establish sites in the Global South, from Latin America to South Africa – efforts that are too late for COVID, but will prove essential for any future pandemic, Rodriguez said.

COVID led to innovation, digitalization in diagnostics

The situation has also led to improvements in diagnostics and innovation. Today, nearly every country in the world now has the capacity to do sequencing of pathogens and share that information publicly so that it can be incorporated into a global response. Variants can be tracked in nearly real time – something that Rodriguez said was not really done before.

Moreover, the cost of testing has gone down, making testing more accessible to LMICs.

Yet, the testing technology has improved, allowing for multi-lineage molecular testing and more, which will change not only the world’s response to COVID but “will transform primary healthcare across the world,” Rodriguez said.

Also, Moyo noted, digital solutions have hit the market, such as mobile apps for communicating testing results, which has made proper diagnostics more viable.

“Some have said we should not waste a crisis,” noted Moyo. “We should use the opportunity COVID has given us to improve public health.”

Global Health Matters is available on Apple Podcasts, Spotify, Google Podcasts, Amazon Music, Stitcher or wherever you find your podcasts.

Read about and listen to more episodes on Health Policy Watch.

This article is part of our TDR Supported Series.

Image Credits: Global Health Matters podcast.

Pro-abortion demonstrators in the US

Americans are bracing for a firestorm over abortion rights as the US Supreme Court prepares to announce its decision soon in the landmark 1973 Roe v. Wade case.

The court’s conservative majority is expected, based on a leaked draft of Justice Samuel Alito’s opinion in Dobbs v. Jackson Women’s Health Organization in early May, to strike down the case. If that happens, 26 of the country’s 50 states are likely to move quickly to ban abortion, according to the Guttmacher Institute, a New York-based NGO that researches and advocates for reproductive rights.

Half of those 13 states — Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, Utah, and Wyoming — have laws in place to automatically end legal abortion services, the institute says, noting that more than half of all US women, or 58%, live in states hostile to abortion where the ban would likely take hold.

In contrast, 16 states and the District of Columbia have laws that protect the right to abortion. They already are preparing for a huge jump in demand for abortion services from women who live in states where the bans would likely be enforced.

58% of U.S. women of reproductive age—40 million women—live in states hostile to abortion rights
Last month, New York State Governor Kathy Hochul announced a $35 million investment to directly support abortion providers in anticipation of Roe v. Wade being overturned. 

“New York has always been at the forefront of the fight for abortion rights, and as the first female governor of New York, I will not let us go backwards,” said Hochul. “This landmark funding will get resources into the hands of clinics who need our help, safeguarding access to abortion in our state and setting an example for the rest of the nation to follow.”   

‘I would not be health commissioner’

This week, New York State Health Commissioner Dr Mary Bassett revealed in Elle magazine that she had an abortion as a medical student.

“How could a first-year intern who was expected to work 36-hour shifts also carry and care for a child? She—I—could not,” wrote Bassett, in a rare public acknowledgement by a high-ranking public official in the US. She later gave birth to two children.

“Had it not been for the abortion I received before I began my internship, I would not be New York’s health commissioner today. More importantly, I would not be the committed mother that I have been able to be to my two adult daughters for over 34 years,” added Bassett, in the article published on Tuesday.

Basset said taking away the right to abortion will not stop abortions, it will only make them “more desperate, deadly, and dangerous,” especially for people who are poor and “communities of color.”

Abortion pills to overcome ban?

Abortion advocates believe medical abortions performed using pills are the best solution for women living in states where bans are introduced. In 2020, so-called medication abortion accounted for 54% of all US abortions, outstripping surgical abortions for the first time.

In a letter to the heads of the US Congress, Hochul appealed for greater financial support for telehealth services and to “ensure the US Postal Service’s ability to ship abortion medication to all states”.

European sanction for US anti-abortion move

Earlier in the month, the European Parliament voted 364-154 to pass a resolution that “strongly condemns the backsliding in women’s rights and sexual and reproductive health and rights (SRHR) taking place globally, including in the US and in some EU member states”.

The resolution, which passed on June 9 with 37 abstentions, says SRHR are fundamental human rights that “should be protected and enhanced and cannot in any way be watered down or withdrawn.” It also cites deep concerns over how bans on abortions “will contribute to the trauma of rape and incest victims.”

Because of those concerns, European lawmakers urged the US government to “fully decriminalise abortion” and to ensure adequate protections exist for “the right to terminate a pregnancy,” including adequate funding needed in the US and globally.

“In countries heavily dependent on US aid for public health programmes, [Roe’s] overturning could have an impact on those governments’ commitment to abortion provision and other reproductive rights,” it said.

At 14, Sierre Leone’s Dankay Kanu (on right) was impregnated by an older man who refused to wear a condom then denied paternity.  She is portrayed here with a mentor from 2YoungLives, a programme that helps pregnant girls and teenage mothers in Sierra Leone.

‘Crisis of unintended pregnancies’ – UNFPA

Earlier in the year, the United Nations Population Fund (UNFPA), which coordinates the UN’s work on sexual and reproductive health agency, reported nearly half of all the 121 million a year in pregnancies worldwide between 2015 and 2019 were unintended. 

“Over 60% of unintended pregnancies end in abortion and an estimated 45% of all abortions are unsafe, causing 5 – 13% of all maternal deaths, thereby having a major impact on the world’s ability to reach the Sustainable Development Goals,” according to the UNFPA.

UNFPA Executive Director Dr Natalia Kanem said the staggering number of unintended pregnancies represents a global failure to uphold women and girls’ basic human rights.

“For the women affected, the most life-altering reproductive choice — whether or not to become pregnant — is no choice at all,” she said. “By putting the power to make this most fundamental decision squarely in the hands of women and girls, societies can ensure that motherhood is an aspiration and not an inevitability.”

Image Credits: Gayatri Malhotra/ Unsplash, Michael Duff/ UNFPA.

Nutritionist Claudette Kayitesi counsels Francois Iyamuremye as he receives his monthly antiretroviral medication at TRAC Plus Clinic in Kigali, Rwanda.

People are living with HIV for much longer thanks to greatly improved antiretroviral treatments. But they also are at disproportionately high risk for non-communicable diseases which affect everyone  more as they age. Now is the time to tackle both in a more integrated way.

The extraordinary advances in science over the past three decades that led to the development of highly effective antiretrovirals have transformed HIV/AIDS from a death sentence into a chronically manageable disease when supported with appropriate diagnosis and care. 

But the rising life expectancy of people living with HIV (PLHIV), and the resultant greying of the HIV epidemic, especially in high-income countries, means that they are as vulnerable to non-communicable diseases (NCDs) as the rest of the ageing population.  

In parallel, People living with HIV are also at a disproportionately high risk of some NCDs, creating an HIV-NCD syndemic. For instance, cardiovascular disease is now one of the leading causes of non-AIDS-related morbidity and mortality in PLHIV, who have a two-fold increased risk of cardiovascular disease compared to the rest of the population.

They also are at higher risk of type 2 diabetes and some types of cancer – for example, there is a nearly six-fold increased risk for cervical cancer among women living with HIV.

The disease landscape has shifted drastically over the past decade. NCDs and injuries are emerging as the leading causes of death and disability, in large part due to global progress made in reducing mortality associated with infectious diseases like malaria, tuberculosis and HIV/AIDS.

NCDs are increasingly affecting people living with infectious diseases, undermining decades of hard-won progress on tackling the HIV/AIDS epidemic.

South Africans struggle with diabetes and HIV 

South Africa, home to the largest population of people living with HIV in the world, also has the highest prevalence of diabetes in sub-Saharan Africa. One in eight South Africans (4.5 million people) are living with diabetes, double the number of less than five years ago. 

Deaths due to diabetes reached nearly 90 000 in 2019, double the figure of a decade earlier. AIDS takes the lives of some 125 000 South Africans each year. There is an inevitable intersection between the two diseases as there is between other NCDs such as hypertension and cardiovascular disease. If we are serious about reducing the shifting disease burden for this and future generations, it can’t be business as usual.

Keeping people living with HIV healthy will require a new integrated approach to disease management that better reflects a person’s health throughout their life course, shifting the focus away from the single health crisis or condition that leads them to seek care in the first instance. 

This emerging approach was given impetus for the first time at last year’s United Nations General Assembly High-Level Meeting on AIDS and reinforced in a recently published report.

Checking blood sugar levels of a patient with diabetes.

Integrated community care

On the ground, there are some good examples of HIV/NCD integration. The Cervical Cancer Prevention Program in Zambia (CCPPZ) is the first-ever cervical cancer prevention initiative for women living with HIV to be funded by the US President’s Emergency Plan for AIDS Relief (PEPFAR). 

The cervical cancer screening services began with two public sector clinics in the country’s capital city (Lusaka) in 2006, and a decade later CCPPZ was operational in 33 government-run health facilities across all of Zambia’s 10 provinces, serving women regardless of HIV status.

By 2015, the program had screened over 200,000 women, and that year it was adopted as the Ministry of Health’s official cervical cancer prevention programme. By focusing initially on women living with HIV, the programme was able to first reach those who were at highest risk of cervical cancer.

A collaboration between Partners in Health and the Malawi Ministry of Health to decentralise HIV/AIDS services in Neno, one of Malawi’s poorest rural districts, in 2007, is another good example of integration. The initiative used community outreach events to identify patients requiring HIV care and mobilise them to go to one of the district’s 12 primary health centres, with active home-based follow-up and support provided by a team of 900+ trained and mentored community health workers.

Specialised HIV/AIDS treatment and care, for those who required it, was available via referral linkages with the district’s two hospital facilities. The initiative proved highly successful with more than 62 per cent of the total expected district population of PLHIV enrolled in the programme by the end of 2015, and a treatment retention rate of more than 85%. 

The programme was then expanded in early 2015 to an Integrated Chronic Care Clinic, providing comprehensive integrated primary care for a range of chronic conditions – including HIV, hypertension, asthma, epilepsy, diabetes and mental health. With political and institutional commitment, initiatives may well become the rule and not the exception for future HIV management across the African region and beyond.

Katie Dain is the CEO of the NCD Alliance.

Lobna Salem is the Regional Chief Medical Officer for Developed Markets at Viatris, a US-based pharmaceutical company. 

 

 

 

 

 

 

Image Credits: Photo credit Jake Lyell/ Bill & Melinda Gates Foundation, LinkedIn .

gavi
A baby being vaccinated against measles in Gonzagueville, Côte d’Ivoire.

A new $100 million initiative to identify and reach zero-dose children – those who have not received a single routine vaccine shot – has been launched today by Gavi, The Vaccine Alliance in partnership with the International Rescue Committee (IRC) and World Vision (WV). 

The Zero-Dose Immunization Programme (ZIP) will be led by the International Rescue Committee in the Horn of Africa, and World Vision in the Sahel regions respectively, reaching 11 countries. As of 2020, there were over four million zero-dose children living across these targeted countries. 

Building on two decades of remarkable progress in expanding the reach of immunization – which has seen the number of children dying from vaccine-preventable diseases in lower-income countries drop by 70% – Gavi’s latest five-year strategy seeks to push even further. 

“Lower-income countries have made remarkable progress in immunization over the last two decades but too many children, particularly those in hard-to-reach areas and fragile and conflict settings are still missing out on life-saving vaccines,” said Anuradha Gupta, Gavi’s deputy CEO.

“We have an opportunity now to build on the progress so far, and reach ‘zero-dose’ children with vaccines as well as other essential health services. There is a reason these communities are consistently missed and therefore to achieve our goal we need innovative approaches, dedicated focus and resourcing, and new partnerships to address their unique needs and realities. 

Reducing ‘zero-dose’ children by 25%

Gavi and its partners aim to reduce the number of zero-dose children globally by 25% in 2021-2025 by addressing barriers that prevent access to immunization. 

ZIP, which falls under Gavi’s new $500 million Equity Accelerator Fund, will commence with a 3-month inception phase during which children will be identified alongside the unique barriers, including gender-related barriers. 

At the end of the inception phase, work plans and relevant targets will be defined, with the goal of addressing identified barriers and reaching as many zero-dose children as possible to increase full immunization. 

Governments will also play a central role in the inception and implementation phase of the initiative and will be involved in the decision-making process. 

Gavi’s Equity Accelerator Fund is dedicated to reducing zero-dose burden in lower-income countries by investing in targeted initiatives. While $100 million will be provided to ZIP, the remaining $400 million will go directly to Gavi-supported countries to identify where zero-dose children are and to sustainably reach them with a full range of vaccines. 

New partnerships needed to close immunization gap

With half of all under-five deaths occurring in zero-dose children, IRC President David Miliband emphasized the need for new partnerships to close the immunization gap. 

“The IRC is proud to be joining forces with Gavi on this urgent issue at this vital time. Traditional approaches have left more than 12 million children without routine vaccination services, and we are determined to show that new partnerships with diverse actors can deliver results and save children’s lives,“ said Miliband. 

The International Rescue Committee will focus their efforts in Ethiopia, Somalia, South Sudan and Sudan. World Vision will take the lead in Chad, Niger, Nigeria, Central African Republic, Cameroon, Mali and Burkina Faso.

Both IRC and WV were chosen for their extensive experience in conflict areas and strong footprint in remote areas. 

“We are committed to partnership—at every level—as it will be critical to address the systemic challenges and barriers limiting access to vaccines,” said Margaret Schuler, Senior Vice President, International Programs for World Vision US.

Image Credits: UNICEF.

A laboratory technician at South Africa’s mRNA hub, Afrigen.

One year since the establishment of the mRNA Vaccine Technology Transfer Hub, a collaboration between two leading biotech companies – Afrigen Biologics and the Univercells group – was announced on Tuesday, paving the way for the development of the first-ever African-owned COVID-19 vaccine through open-access intellectual property. 

Using intellectual property from partners, the collaboration between the South Africa-based Afrigen and the Belgium-based Univercells will focus on the development of a novel mRNA vaccine.

The companies intend to collectively tackle two major challenges that have hampered COVID-19 vaccine rollout in Africa and other low- and middle-income countries (LMICs): lack of local cost-effective production, and the need for cold- or super-cold chains. 

“The COVID-19 pandemic has shown that there is a pressing need to build African capabilities in vaccine development and manufacturing. Without the capacity to make their own vaccines, too many countries haven’t been able to access them,” said Professor Petro Terblanche, Afrigen managing director, speaking at an event to mark the signing of the agreement.  

“This agreement is an important step towards ensuring that everyone, everywhere – in Africa,  and across low and middle-income countries (LMICs) – has access to life-saving vaccines and medicines.” 

The collaboration will be hosted by Afrigen in Cape Town, South Africa. Afrigen hosts the World Health Organization’s (WHO) Global mRNA Vaccine Technology Transfer Hub and is working to facilitate the production of mRNA vaccines at over 15 designated manufacturing sites in LMICs globally. 

The agreement, and the eventual vaccine produced, will build on expertise developed using the hub.  

Local production and heat-stable vaccine  

Belgian Minister of Development Co-operation, Meryame Kitir, and WHO Director-General Dr Tedros Adhanom Ghebreyesus, during a visit to South Africa’s mRNA vaccine hub in February.

At present, African countries import 99% of all the vaccines they use. While more than 60% of the global population has been fully vaccinated, some LMICs have yet to cover 1% of their population. 

An African-owned COVID-19 vaccine is a critical step in closing the gap in vaccine accessibility and coverage. 

Furthermore, cold chain storage and distribution are additional hurdles to the roll-out of existing mRNA vaccines, made by Pfizer and Moderna. The agreement paves the way for the production of an mRNA vaccine that can be used in regular refrigerators, making it easier to store and distribute in rural and remote locations where few people are currently vaccinated. 

Speaking on the partnership with the WHO mRNA Transfer Hub, Martin Friede of WHO Vaccines and Biologicals said: “This unique partnership model enables the sharing of information, technology and human capital, and has the potential to shape vaccine production worldwide. The WHO and its partners are committed to  ensuring that we build a robust system to further the cause of vaccine equity and access.” 

New model of manufacturing mRNA vaccines 

In addition to developing a novel vaccine, the collaboration intends to pioneer a new model of manufacturing for mRNA vaccines.

Quantoom Biosciences, a Univercells company, is developing an mRNA production technology that encompasses all the steps of RNA production, from sequence construct to large-scale production, which allows for rapid growth and scale-up.

The technology was built with distributed and decentralized manufacturing in mind, which ensures that processes can be easily transferred across LMICs. 

The COVID vaccine produced on the Univercells system – which has been named eTheRNA – will have improved thermostability, meaning it will resist losing potency at higher temperatures. This is critically important in LMICs.

[The technology] will allow for storage in normal fridges which are more accessible than -20 or -80°C freezers, especially in LMIC,” said Bernard Sagaert, Chief Operating Officer of eTheRNA. 

“All of these technologies are needed for the end goal of making a vaccine accessible for low and middle income countries. We are very happy to be part of this initiative and work together to enhance the prospects of making vaccines more accessible globally.

Image Credits: Rodger Bosch for MPP/WHO, Kerry Cullinan.

uv
Woman applying sunscreen.

A new app for mobile phones that provides localized information on ultraviolet (UV) radiation levels has been created by the World Health Organization (WHO), the United Nations Environment Programme (UNEP), the World Meteorological Organization, and the International Labour Organization (ILO). 

The app is available free of charge on both the Apple App and Google Play stores for Iphones and Androids, and includes national and local data streams for UV and weather forecasts. It is available in multiple languages – Chinese, English, French, Russian, Dutch, and Spanish. It’s also a rare example in the UN system of a growing trend – harnessing real-time environmental data for public use and greater health benefits. 

Launched to coincide with the first day of summer in the northern hemisphere, the SunSmart Global UV app provides 5-day UV and weather forecasts at searchable locations. The app is based on the 11-point UV Index scale, with 1 (“Low”) to 11 (“High”) representing the potential for UV damage to skin and eyes. 

In an effort to reduce the global burden of skin cancer and UV-related eye damage, the app also highlights time slots when sun protection is required with the aim of helping people around the world know when to use sun protection. Using sun protection is recommended when the UV index is 3 or above. 

“Evidence shows that overexposure to UV is the major cause of skin cancer. So it’s vital for people to know when and how to protect themselves,” said Dr Maria Neira, WHO Director, Department of Environment, Climate Change and Health.

Skin cancer from prolonged unhealthy exposure to UV radiation is highly preventable 

It is estimated that over 1.5 million cases of skin cancer (melanoma and non-melanoma) globally were diagnosed in 2020. And during that same year, more than 120,000 people lost their lives to this highly preventable disease. 

One of the leading factors contributing to skin cancer is the penetration to earth of excess UV radiation as a result of the earth’s thinning stratospheric ozone layer. 

In the course of the last century, the stratospheric ozone layer was significantly depleted as a result of the increased use of, and release to the atmosphere, of certain ozone depleting chemicals, including chlorofluorocarbons (CFCs), hydrochloroflourocarbons (HCFCs), as well as methyl bromide and other bromoflourocarbons into the atmosphere. Such chemicals are used in refrigeration, air cooling, aerosols, and other applications, and in the case of methlbromide, as a pesticide and fumigant agriculture.

While the most powerful ozone-depleting chemicals were banned by the UN Montreal Protocol of 1987, others have continued to be used – and in any case ozone that is already depleted takes years to rebuild.  

Global health leaders and experts encourage use of the app to prevent and protect against prolonged unhealthy exposure to UV radiation. 

”We encourage everyone to use the application to  protect themselves and their children, and to make this a daily habit,” said Neira. 

“The SunSmart App is a fantastic UV monitoring tool, and I would encourage everyone to use it,” advised Meg Seki, Executive Secretary of UNEP’s Ozone Secretariat.

Contributes to safe and healthy work environments, says ILO

The ILO describes the SunSmart app as relevant to both workers and employers in outdoors occupations, enabling them to identify hazardous work conditions and plan protective safety and health measures accordingly.  The app’s release follows the ILO’s adoption of a resolution to add a safe and healthy work environment as part of its Fundamental Principles and Rights at Work earlier this month. 

“It is a global call for increased efforts to prevent work-related injuries and diseases. Tools such as SunSmart Global UV are a small but useful contribution to this endeavour,” said Vera Paquete-Perdigão, Director of the ILO’s Governance and Tripartism Department.

Image Credits: Fort George G. Meade Public Affairs Office/Flickr .

africa cdc
Ahmed Ogwell Ouma, Africa CDC’s Acting Director (right) with WHO Director General Tedros Adhanom Ghebreyesus (left)

Africa CDC wants to be able to declare public health emergencies of continental security but the WHO warns this could be a risky move that could isolate African countries and create confusion regarding response.

The World Health Organization’s African Regional Office (WHO AFRO) has found itself explaining its disapproval of the Africa CDC’s quest for a mandate allowing it to be able to declare a “Public Health Emergency of Continental Security.”.

Last week, news broke that the WHO was mounting a drive to curtail Africa CDC’s ambitions to expand its powers – and particularly its request to African Union ministers of health to be empowered to declare a “Public Health Emergency of Continental Security”. 

The issue emerged as about 40 African Union health ministers convened in a meeting last week to discuss revisions to the statutes under which Africa CDC operates, which could give it more authority, including the power to declare regional or continent-wide health emergencies. 

At the meeting, 12 ministers reportedly supported WHO’s call to limit Africa CDC’s powers to declare such emergencies – which sources say  was a result of WHO’s lobbying of member states. The health ministers are due to reconvene again Tuesday to make a final recommendation on the amendments – which would eventually be placed before the AU Executive Council for a decision. 

In a statement, WHO’s African Region (AFRO) called for the assessment of the proposed policy’s benefits and risks to member states. It noted that while the policy change could reduce Africa’s dependence on others, it could also trigger more travel and trade restrictions and isolate the continent as occurred with the travel bans imposed by many countries in southern Africa after scientists there identified the emergence of the Omicron variant of the SARS CoV2 virus.

Arrivals to border control at London’s Heathrow Airport – quarantine rules were based on where they were vaccinated – and not the vaccine received.

“WHO believes a careful reflection on the interfacing between the declaration of a public health emergency of continental security and the global process would be of benefit,” WHO stated.

Speaking with Health Policy Watch Dr Abdou Salam Gueye, WHO AFRO’s Regional Emergency Director, added that creating a new type of emergency declaration at continental level, under the administration of Africa CDC rather than WHO, also could lead to confusion. And this he said could delay, rather than speeding up, countermeasures. 

At the same time he added, ““I believe that WHO is very open to discuss and see the best way to settle this issue.” 

Africa CDC’s acting director says more authority is justified 

Explaining why Africa CDC needs the mandate, Ahmed Ogwell Ouma, Africa CDC’s Acting Director, noted that African Union emergency response procedures – from recruiting response teams to medicines and vaccines procurement – cannot be activated without some kind of formal declaration of a public health emergency. 

“At the moment, that declaration of emergency is usually at two levels. First is at the national level. Governments are able to make that declaration that there is a public health emergency within their own borders. And beyond the borders, the WHO usually does that at the Geneva level,” Ouma said, speaking at an Africa CDC briefing last Thursday.

That, he noted, is the reason that AU policy organs are considering mandating Africa CDC to be able to declare regional public health emergencies within Africa, in order to ensure improved  continental health  security. 

Regional alert system doesn’t really exist

WHA President Dr Hiroki Nakatani of Japan applauds the decision of the 75th WHA to update the International Health Regulations.

Currently, WHO is only empowered under its International Health Regulations to declare public health emergencies at the global level and not at regional level.  

While there has been much criticism of this “binary” approach to the rules, it will take several more years to make amendments to the existing IHR, under a process that was just approved at last month’s 75th  World Health Assembly. 

And if there was to be a change in the existing yes-or-no alert system, the solution that has been most discussed is the addition of a global “yellow light” warning, rather than regional signals.  

Past history, however, has shown that it took considerable time for regional outbreaks in Africa to rank as sufficiently severe to warrant a global health alert. In the 2014-2016 Ebola outbreak in West Africa, a WHO public health emergency of international concern (PHEIC), was only declared in August 2018 – more than eight months after the first Ebola virus cases were reported in Guinea – and 6-8 months after the virus had already spread well into Liberia and Sierra Leone. 

In the case of the 2018 Ebola outbreak in the Democratic Republic of Congo,  there were 3 meetings of WHO’s Emergency Committee after the outbreak first began in May before a fourth meeting activated the PHEIC alarm in August 2018. Although considered a rapid response, in comparison to 2014, by that time the virus had already spread to Uganda, was threatening the borders of some 7 other states, and 1,700 people had already died.

Potential spillover of Ebola virus during the 2018-2020 outbreak to nine countries sharing borders with the Democratic Republic of Congo (Wadoum et al, 2021)

The experience underlines the importance of greater inter-African planning and cooperation on outbreak response, coordinated by Africa CDC, in the words of one retrospective study by a group of African and European researchers. 

Africa is split between two WHO regions

Another problem with WHO’s alert system is that within the global health agency,  responsibility for Africa is actually split between two WHO regional bodies – the AFRO region, which coordinates responses in sub-Saharan Africa and the Eastern Mediterranean Regional Office (EMRO). EMRO actually  includes seven African countries – Djibouti, Egypt, Libya, Morocco, Somalia, Sudan, and Tunisia – among its 21 member states and the occupied Palestinian territories, whose territories extend as far east as Afghanistan. 

While the split reflects the traditional cultural and political affiliations of north African with predominantly Muslim states elsewhere in the EMRO region – it also is artificial in terms of the ways in which diseases spread. 

But even if WHO were ever to be empowered to declare regional health emergencies, in the case of Africa,  such a declaration would automatically exclude Africa’s “EMRO” countries which might also be at risk. Or conversely, it would include EMRO countries even though the outbreak may not be relevant to Middle Eastern states  thousands of kilometers away.   

Africa CDC announcement would trigger faster response  

Africa CDC argues that if its request is granted by the AU Executive Council, there would be no change from the standpoint of WHO’s global alert system.  Ouma said emergency procedures would still be activated if WHO makes a pronouncement in Geneva for a public health emergency of international concern. 

But in addition, those procedures could also be triggered if Africa CDC were to make a pronouncement on a public health emergency of continental security – providing a more granular level of alert.

“Emergency set of procedures that will kick in are very similar,” he stressed.

He added that if and when the Africa CDC is eventually granted such authority by the African Union, the center would be able to focus on outbreaks that are largely endemic to Africa. And in that way, response will be faster and containment more effective.  

“We do not have to wait for a long time for a pronouncement to be made. That is our expectation indeed. And that is the expectation with the African Union. That is why this request has been made,” Ouma said.

WHO’s concerns

Preparation and disinfection of a house in Moto, Bikoro,
Equateur Province, after the discovery
of a confirmed Ebola case.

Dr Matshidiso Moeti, WHO AFRO’s Regional Director, told Health Policy Watch that WHO is not lobbying against the move among African ministers of health, who must render a decision. But rather  WHO aims to help them understand the pros and cons of outbreak declarations by different organizations and at different levels.  

“We would recommend that any decision made after this analysis lend itself to a rapid response, mobilization of resources – but also ensure that such declarations don’t then result in the type of isolation that we have seen in the past happen when countries are revealing information about outbreaks,” Moeti said.

Along with travel bans imposed on southern Africa following the identification of the Omicron variant, developed countries have frequently imposed travel advisories in the wake of African  national  outbreak  alerts.  For instance, the United States Centers for Disease Control imposed restrictions on incoming travelers from Guinea and DRC following Ebola outbreaks that involved only a handful of cases in each country.  Moeti expressed WHO’s interest in supporting its Member States and partners to think through such processes.

Aligning and streamlining WHO and Africa CDC efforts

Every year in fact, WHO responds to over 100 public health outbreak events of different sizes and different severity. Outbreaks at national level are declared by national government authorities.  But in the case of Africa or other developing regions, national outbreak announcements are closely coordinated with  WHO and those may also be greatly delayed – as was the case of the Malawi polio outbreak alert last February – which occurred three months after the polio case was first reported.  

Speaking in May at a pre-World Health Assembly briefing  Gueye noted that as with so many other issues in Africa’s health system, there is need for improved coordination between WHO and African members states generally.

Open Briefing to 75th WHA: Left to Right: Priti Patnaik, Agnes Soucat of the French Development Agency and WHO’s Abdou Salam Gueye discuss the global architecture for health emergencies response.

“We need several Africa CDCs in order to tackle those issues,” said Gueye, speaking metaphorically about the need for more resources overall. “What we need is just to have a coordination mechanism where what needs to be done will be clarified, and also people will work together in a complementary manner,” Gueye said. 

Gueye said he had recently visited Addis Ababa, Ethiopia’s capital city, where he discussed with colleagues at the Africa CDC ways to improve collaboration.

“We said what we want to do and they said what they want to do,” he related, suggesting a more formal coordinating mechanism could also be useful. “We could complement each other at any point and there is a place for an additional organization to work together. We need better streamlining in order to know what the other is doing and where we can really put our force together and succeed.”

Elaine Ruth Fletcher contributed to this story.

Image Credits: Ahmed Ogwell/Twitter , @HeathrowAirport/capt_saini, Wadoum et al, 2021, Journal of Risk Management and Healthcare Policy, WHO/Junior D. Kannah, Benoit Varenne , Badur et al (2019).

MC12 Chairman Timur Suleimenov gavels the end of the closing session with WTO Director General Ngozi Okonjo-Iweala early Friday morning.

Limited IP waiver text says WTO members “will decide” on inclusion of COVID-19 tests and treatments within six months. 

The World Trade Organization’s first ministerial conference in four and a half years reached agreement early Friday morning on what officials described as “an unprecedented outcome” of six agreements, including a deal to curb some fishing subsidies that deplete ocean stocks, a limited waiver of WTO’s intellectual property protections on COVID-19 vaccines and a humanitarian food security measure – all of which will have wide-ranging impacts on global public health.

In a tactical victory for medicines access advocates, WTO members agreed to insert a clause in the final text on the IP waiver for COVID-19 vaccines stating that “no later than six months from the date of this decision, members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics.”

While there is now a global surplus of vaccines making the waiver in existing IP for the jabs almost meaningless, any future decision to extend the waiver of certain IP protections to COVID-19 tests and treatments — which are much easier to produce and also still in very short supply in many countries — could be more impactful.   

Two overnight sessions before white smoke emerged 

WTO’s director-general, Ngozi Okonjo-Iweala, presides over the 12th Ministerial Conference (MC12)

WTO’s marathon talks involving more than 100 trade ministers lasted a day and a half longer than planned and included two sleepless nights. Kazakh politician Timur Suleimenov, who chaired the conference, said it “feels like a very long and gruelling marathon” but he was happy to show that the WTO can deliver and address some of the global challenges.

“We actually needed to showcase to the world that multilateralism is alive, and the rules-based system is alive,” said Suleimenov, a deputy chief of staff to Kazakhstan’s president, at a closing press conference. “We did need an extra day — actually two — to prove to the critics that they were wrong, and I think we did a little more than that. And I think we have reached a remarkable outcome.”

The six decisions and ministerial declarations were endorsed and accepted by all of WTO’s 164 member nations, he said, paving the way for WTO “to be ready for future crises.” The long-fought deal to curb fishing subsidies for fishing of over-exploited species and on the high seas, he said, is “a unique and unprecedented accomplishment” that will help deal with the global food crisis. “We have a successful, and some would call it maybe, historical conclusion,” he added.

WTO’s director-general, Nigerian-American economist Ngozi Okonjo-Iweala, said she was exhausted, since “we haven’t slept for two nights, we were here throughout,” but the conference had produced “an unprecedented outcome” that would have “very tangible results” for citizens worldwide.

Agreement on agricultural measures elude members

Protests Wednesday, 15 June, outside of the World Trade Organization against existing WTO rules that developing countries say unerasonably limit public food stockholding

She said the only major area in which WTO member nations were not able to agree was a draft decision on agricultural reform  — where developed country opposition to  developing country demands for an easing of WTO rules around public stockpiling of vital food supplies eventually foiled a comprehensive deal.

However, the final draft of a ministerial declaration on food insecurity reaffirmed the importance of improving ”  the functioning and longterm resilience of global markets for food and agriculture, including cereals, fertilizers, and other agriculture production inputs,” considering specific needs of developing and  net food-importing developing countries.”  The agreement also acknowledged that “adequate food stocks can contribute to the realization of Members’ domestic food security objectives,” although it encouraged members with available surplus stocks to release them
on international markets.

Even so, the six other deals may go a long way to restoring WTO’s credibility as a vital global institution. Its last ministerial conference in December 2017 at Buenos Aires failed to clinch a single deal. And, in 2019, WTO’s appellate body for settling trade disputes virtually ground to a halt due to U.S. opposition to refilling judges on its bench. A former World Bank managing director and Nigerian foreign minister, Okonjo-Iweala took the helm of the WTO last year and was resolved to restore the global trade body’s relevance.

“I want to say how delighted I am and excited that we’ve been able to prove that the WTO can deliver, and deliver multilateral outcomes. When I started this job, I mean, the expectations of the WTO were not very high, to be kind about it,” she said. “But today we’ve shown that the WTO can produce outcomes, and multilateral outcomes like that. So we were expecting one or two deliverables … and we got six.” Since WTO operates by consensus, any single nation can block a deal.

“It was not an easy process, an easy road,” Okonjo-Iweala added, laughing. There were a lot of bumps, just like I predicted. It was like a roller coaster. But in the end, we got there.”

Harmful fisheries subsidies — not the full deal but… 

Commercial fishing boat

She called the deals “very, very substantive outcomes,” including the TRIPS vaccines waiver and a companion declaration on WTO’s pandemic response; a declaration to exempt World Food Programme purchases from export restrictions; and the decision to curb environmentally harmful fishing subsidies that cap 21 years of negotiations on subsidies that experts say have enabled big rigs to plunder the high seas far from home countries, driving a depletion of 30% of the world’s fish stocks. 

 “Although it is not the full package,” she said of the fishing subsidies deal, rather than keep disagreeing “we were able to say, ‘Okay, where do we all agree on?’ … That is stage one,” Okonjo-Iweala said.

Notably, the final agreement still prohibits subsidies to fishing of stocks on the high seas that are not managed by regional bodies, the International Institute for Sustainable Development said in a statement. It prohibits subsidies for vessels and operators engaged in illegal, unreported, or unregulated (IUU) fishing, and it establishes new rules for subsidies for the fishing of stocks that are already over-exploited – requiring countries to rebuild the stocks “to a biologically sustainable level” if it continues to subsidize such fishing. And the treaty contains certain flexibilities for developing country WTO members, known as special and differential treatment.

WTO members also agreed to continue negotiations on issues that fell by the wayside in the draft text, with an eye to an agreement by MC13 to “achieve achieve a comprehensive agreement on fisheries subsidies, including through further disciplines on certain forms of fisheries subsidies that contribute to overcapacity and overfishing.” Developing countries led by India had protested a broader curtailment of subsidies, including for fuel, at this stage, saying it would harm artisinal fishermen – who also may fish up to 100 nautical miles offshore – although critics said the India also was more concerned with protecting its industrial fishing fleets.

Agreement matters

Buying fish from a vendor at Gosa Market, Abuja, Nigeria

However imperfect, the agreement is a turning point after 20 years of negotiations over the subsidies at a time when 90% of the world’s fisheries are fully exploited or dangrously depleted, according to the FAO, threatening global food security – and a protein source upon which one-third of the world’s population relies.

“This agreement matters because it will require governments to think critically about their subsidy policies and how they interact with efforts to manage natural resources sustainably,” said Alice Tipping, who leads IISD’s program on sustainable trade and fisheries subsidies. 

The U.S.-based Pew Charitable Trusts said the fishing subsidies deal will help curtail overfishing and improve ocean health by creating a global framework to limit subsidies for illegal, unreported, and unregulated fishing. “This is a turning point in addressing one of the key drivers of global overfishing,” said Isabel Jarrett, who manages Pew’s campaign against fishing subsidies.

“Now, WTO members need to bring the treaty into force as swiftly as possible and implement it in good faith,” she said. “Recognizing that there are still outstanding issues for WTO members to discuss, we were pleased to see them commit to recommending further rules on harmful fisheries subsidies at the next ministerial conference.”

India’s trade delegation also had been blocking agreements on the fishing subsidies, but India’s Commerce Minister Sri Piyush Goyal seemed to hint it was a negotiating tactic when he told reporters on the fifth day of negotiations that his delegation still believed the conference “will turn out to be one of the most successful ministerials that the WTO has seen in a long time.”

Partial IP waiver criticized on all fronts 

Protest in Indonesia against the delay in WTO’s approval of a TRIPS waiver for COVID-19 vaccines.

The long delayed deal on a partial IP waiver for COVID-19 vaccines aims to ease rules under which developing countries can produce and export biosimilar (generic) versions of vaccines, without permission from patent holders. It passed after last-minute input from the United States and China, Okonjo-Iweala said. 

Presumably, the United States had to agree to the clause providing for negotiations over tests and treatments in six months time; until now, it had only agreed for the waiver on vaccines — much to the chagrin of vaccine advocates.  

As one of the world’s biggest vaccine exporters, China also had to agree to waiver language that implicitly excludes it from the IP exemption.  A footnote in the agreement says developing countries that can make COVID-19 vaccines “are encouraged to make a binding commitment not to avail themselves of this decision. Such binding commitments include statements made by eligible Members to the General Council, such as those made at the General Council meeting on 10 May 2022, and will be recorded by the Council for TRIPS and will be compiled and published publicly on the WTO website.”

China, which exported more than 10% of the world’s COVID-19 vaccines in 2021, had explicitly said in the General Council proceedings that it would not avail itself of the waiver, but it objected to language explicitly excluding large developing country exporters.   

The temporary waiver, overrides some existing WTO “TRIPS” protections on intellectual property, enabling developing countries to produce and export COVID-19 vaccines without a license from the patent-holder, under somewhat relaxed terms.

Final IP waiver deal denounced by co-sponsor India and pharma industry 

WTO
Press briefing Wednesday in Geneva by civil society opposed to the WTO draft text on an IP waiver for COVID vaccines with UN AIDS Executive Director Winnie Byanyima (second from right)

But unlike the deal on fisheries subsidies, there was no celebration over the final IP waiver text – which is limited in scope as well as carrying a number of new conditions that many original advocates described as potentially dangerous precedents. The text came in for immediate criticism by the the pharma industry as well as by India, one of the original co-sponsors of the waiver initiative. 

Pharma industry leaders share a “deep disappointment with the decision taken to adopt a TRIPS waiver, despite intellectual property (IP) not being a barrier to vaccine scale-up and wide acknowledgement of vaccines surplus,” the Geneva-based International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) said in a statement.

Médecins Sans Frontières (MSF) described it as a “devastating global failure”, while Ellen t’Hoen, of Medicines, Law and Policy said it was “no longer a TRIPS waiver in the sense it was proposed by South Africa and India in October 2020.”  Although she acknowledged that the new measure “may make the issuing of a compulsory licence easy and swift and will help the few countries that currently do not have workable compulsory licensing mechanisms.”

Jamie Love, of Knowledge Ecology International said that “while the text is not expected to impact COVID-19 vaccine equity much or at all, there are some silver linings.” He named those as the: “shorter and more usable” requirements for notifying WTO of vaccines produced under the waiver for export, as well as the waiver of any limitation on imports by countries with no manufacturing capacity of their own.

“If the decision is extended to therapeutics in six months, it may be much more value, given the supply constraints on therapeutics and the much better regulatory pathway,” he added.

India meanwhile said that the long-delayed agreement on the vaccine IP waiver had lost its relevance in light of the vaccine oversupply. “What we are getting is completely half-baked and it will not allow us to make any vaccines,” India’s Goyal said in a statement posted earlier this week on his ministry’s website. “It’s just too late. There is no demand for vaccines anymore.”

He said, however, that his nation hopes the measure will lead to a broader deal a half-year from now: “Our hope and desire was that this will be the beginning and in 6 months they will decide over the therapeutics and the diagnostics.”

Elaine Ruth Fletcher contributed to the reporting and writing of this story. 

Image Credits: @ITforChange, World Trade Organization, Michael Casmir, Pierce Mill Media, Nur Sofi Iklima , MSF Access .