Dr. Sally Agallo Kwenda, survivor of cervical cancer

In the early 2000’s, when Kenyan doctor Sally Agallo Kwenda was diagnosed with cervical cancer, it was a big shock given she was not experiencing any pain or symptoms.

A bigger shock, however, was her husband’s decision to walk out on her. He claimed that he could not live with a woman who could not give him babies. 

Sally’s testimony is a sobering reminder of the devastation cervical cancer brings, even though it is almost entirely preventable and potentially curable, noted the World Health Organization’s Dr Tedros Adhanom Ghebreyesus on Monday.

She spoke along with nearly a dozen other cancer survivors from around the world at the historic launch of the WHO‘s Global Strategy to Accelerate the Elimination of Cervical Cancer.  It marked the first time ever that the world has committed to eliminating a cancerous disease – and an especially neglected one that kills a whopping 300,000 women every year. 

Coinciding with the launch, countries around the world, beginning with Japan and Australia, began lighting up landmark monuments in the color teal and blue, in a worldwide display of unity to eliminate cervical cancer once and for all. 

Princess Dina Mired of Jordan

Princess Dina Mired of Jordan, along with the first ladies of South Africa and Rwanda also appeared for the launch at a high level panel, alongside WHO’s Director General as well as officials of Unitaid, GAVI, the Vaccine Alliance, The Global Fund and others.

“Today is the day we tell cervical cancer, loud and clear – your days are numbered,” said Princess Dina Mired of Jordan, a longtime advocate for cervical cancer elimination, and member of the director-general’s expert group on cervical cancer elimination. 

“We have let you run wild, causing much destruction and grief to hundreds of thousands of our women and their families for far too long. And the worst part is, you managed to do all of that, not because you were super smart, but simply because we let you infect women.”

“We made it easy for you, but not after today, because today we have a plan,” she added. “A solid plan to put you back where you belong – to the annals of history.”

The WHO’s three-pronged strategy, which was adopted by the World Health Assembly in a remote vote during August, offers a clear roadmap to expand Human Papilloma Virus (HPV) vaccination coverage, as well as cervical cancer screening and treatment by 2030: 

  • 90% HPV vaccination coverage of girls by age 15.
  • 70% screening coverage for women by age 35 and again by 45.
  • 90% access to treatment for cervical pre-cancer and cancer, including access to palliative care.

If successful, the WHO’s strategy could prevent over 40% of new cases of the disease, and 5 million related deaths by 2050, 90% of which are in low- and middle-income countries.

HIV & Cervical Cancer – The Double Whammy

Cervical cancer, like many other diseases, exploits those with weakened immune systems, especially in sub-Saharan Africa where HIV is still rampant, added panelists on Tuesday.

In fact, 85% of women that live with both HIV and cervical cancer are in sub-Saharan Africa, according to a meta-analysis of 24 studies from Monday, which was published in The Lancet.

Shockingly, women with HIV are six times as likely to contract cervical cancer, warned Shannon Hadder from UNAIDS, referring to the Lancet report. This explains why women in eastern and southern Africa are ten times more likely to die of cervical cancer, in comparison to women in Western Europe or Australia. 

She also warned that innovative technologies, such as artificial intelligence based screening tools, will not fulfill their potential unless we confront deep social inequities that impede access to preventative care and treatment. 

“This situation is not acceptable, and that’s why we don’t accept it,” added Marisol Touraine, chair of Unitaid and a former  French Minister of Social Affairs. “We cannot accept inequity because we have effective tools and solid policies [to prevent and treat cervical cancer].”

Even in countries that have the tools to offer high-quality care, gender inequities, as well as misinformation, are substantial roadblocks to improved cervical cancer management. In Swaziland, for example, 63% of men and 58% of women agreed that they had to seek permission from their male partner to visit a health care center, said Hadder, referring to a recent nationwide survey. 

Misinformation is another challenge that needs to be addressed quickly, she said, noting that in the same survey, 48% of respondents felt that only women with multiple partners were infected by cervical cancer. 

“There’s nothing shameful about our biology, and no woman needs permission from a man to access health care.”

High HIV rates in Sub-Saharan Africa exacerbate cervical cancer

Cervical Cancer – Treatable with Cost -Effective Strategies 

Eliminating cancer would have once seemed an impossible dream, but we now have cost-effective tools to make that dream a reality, said Dr. Tedros on Monday. 

Investing in cervical cancer can generate substantial societal and economic returns. For every dollar invested, the WHO estimates a US$ 3.20 return to the economy – and the figure rises to US$ 26.00 when the indirect benefits on families, communities and societies are considered.

Even though 93% of all cervical cancers are preventable, it is the fourth most common cancer in women worldwide. In 2018, an estimated 570 000 women were diagnosed with cervical cancer, and about 311 000 women died from the disease.

Almost all cervical cancer cases (99%) are linked to infection with high-risk human papillomaviruses (HPV), an extremely common virus transmitted through sexual contact.

Image Credits: The Lancet .

TB screening activities in a rural village, Cambodia.

Médecins Sans Frontières. As the COVID-19 pandemic threatens to derail the global response to tuberculosis (TB), Médecins Sans Frontières/Doctors Without Borders (MSF) called on governments to accelerate testing, treatment, and prevention for TB, and called on donors to provide the financial support needed to ensure increased access to new medical tools for diagnosing and treating millions of people with this killer disease. A report released today by MSF and the Stop TB Partnership—Step Up for TB—surveys 37 high TB-burden countries and shows that critical medical innovations are reaching far fewer people who urgently need them, because many countries continue to lag behind in getting their national policies in line with new World Health Organization (WHO) guidelines.

“Instead of stepping up for TB, we are at risk of slipping back due to COVID-19,” said Sharonann Lynch, Senior TB Policy Advisor for MSF’s Access Campaign. “We cannot stress enough how urgent it is now for governments and donors to intensify their efforts so thatcritical medical innovations and tools reach people with TB. We finally have better drugs and tests to tackle and prevent this extremely infectious yet curable disease, so it’s both mind-boggling and unacceptable that they’re still not being used to save as many lives as possible.”

While reporting on the severe impact of the COVID-19 pandemic on TB services, WHO revealed a sharp drop in the number of people diagnosed. Besides needing to catch up to maintain continuity of existing TB services, it advised countries to adopt and roll out better testing policies and practices. 

Presently, countries continue to fall short on rolling out up-to-date testing policies that can assist in reaching nearly 3 million people still being missed.As highlighted in the report, a whopping 85% of countries surveyed still do not use the lifesaving point-of-care urinary TB LAM test for routine diagnosis of TB in people living with HIV, as recommended by WHO. 

“As clinicians working on the frontlines of the raging TB epidemic, it is distressing to see the sluggish uptake of TB LAM in national treatment programmes, despite its proven role in saving the lives of people living with HIV,” said Dr Patrick Mangochi, Deputy Medical Coordinator for MSF in Malawi. “Countries must step up the use of TB LAM as a core component of testing services, otherwise delays in diagnosing people with TB and getting them started on treatment will continue to fail people with HIV who get TB.”

TB remains the world’s top infectious disease killer, with more than 10 million people falling ill and 1.4 million people dying due to this disease in 2019. Implementing WHO guidelines is urgently needed to minimise the unnecessary risk of COVID-19 by reducing visits to health facilities, without disrupting treatment. Countries must take immediate action to implement people-centred TB policies, including treatment initiation and follow-up at primary healthcare facilities. Also, national treatment programmes must prioritise the use of all-oral treatment regimens for people with drug-resistant TB (DR-TB) that no longer include older, toxic drugs that have to be injected and cause serious side effects. The report finds that only 22% of countries surveyed allow TB treatment to be started and followed up at a primary healthcare facility, instead of travelling to a hospital, for instance, and for medicines to be taken at home. Additionally, 39% do not use a modified all-oral shorter treatment regimen and 28% of countries surveyed still are using injectable medicines when treating children with DR-TB.

“I have been through an agonising journey of being treated with medicines with excruciating side effects, and lost one of my lungs,” said Meera Yadav, a survivor of extensively drug-resistant TB (XDR-TB) in Mumbai, India.“Finally, in 2016, I was able to access newer TB drugs as part of the regimen that saved my life. I don’t want anyone else to have to go through this ordeal. With newer medicines, it is now possible to give people all-oral treatment that works to cure them. People with TB can’t be excluded from accessing these innovations anymore, especially when they are afraid to visit treatment centers due to COVID-19.”

Image Credits: Yoshi Shimizu/WHO.

Women health workers in LMICs are often the targets for research but are rarely part of the decision-making process, Dhatt says.

Women must be exposed to digital technology as both users and innovators – in order to fashion and expand AI designs that meet the needs of hard-to-reach populations, said experts at a Geneva Health Forum.

Speaking at the session ‘How Can The World Advance Towards AI Maturity In Health?’ on Monday, Roopa Dhatt, executive director of the Women in Global Health network, noted that only 12% of people in AI research are women.

And while women health workers in low- and middle-income countries (LMICs) are the majority of front-line care givers and thus the target of many AI research solutions, they are “rarely part of the design or decisions”.

Roopa Dhatt, executive director of the Women in Global Health.

“We hear about human-centred design, but how often are we making sure the creators are people of diverse backgrounds?” Dhatt asked, whose network aims to advance gender equity in the health sector. She added: “We need to hardwire diversity and equity in all of our aspects of innovation.

“So the first thing is making sure that we have people from diverse backgrounds.”

The concern, she said, is that if “100% of the talent pool in health isn’t engaging, you are not going to get the best results”.

There is a similar disconnect between AI research goals and the prevailing levels of digital literacy among women. Globally, some 1 billion women do not currently have access to digital mobile technology, with a large majority of these women living in LMICs.

“That’s a pretty large number,” she added. “To say that you’re going to work on achieving universal coverage and health equity when a billion of the world’s population does not even have access to digital technology.”

Half of women’s contributions to global health remains unpaid.

The gender gap in health sector leadership is another link in the broken chain of digital transformation, she added, noting that around 70% of the global health workforce are women, but less than 25% of leadership roles are occupied by women. In addition, half of women’s contribution to global health remains unpaid.

Country Context Also Critical To Appropriate Research

“When it comes to digital specifically, it’s really important to understand what the context is,” said Kanishka Katara, Head of Digital Health (India) at PATH: a French-based non-profit that helps countries develop and scale digital technologies in health systems.

Kanishka Katara, Head of Digital Health (India) at PATH

Katara flagged, as an example, that countries have diverse responses based on the context of their national local health systems and health burden – which varies enormously, country to country.

“Issues from one place to another, even though they might appear to be the same, are very different,” he said. “We need more contextual, localised solutions for that.”

The Geneva Health Forum runs from 16-18 November. Follow Health Policy Watch’s coverage here and on Twitter.

 

 

 

Image Credits: WHO/UNITAID, Flickr – UN Women Asia and the Pacific, Geneva Health Forum.

Geneva Health Forum session. Pictured on screen, clockwise: Neda Milevska Kostova, Bisi Bright, Karen Alparce-Villanueva, Angela Grezet, & moderator Arianne Alcorta.

The COVID-19 pandemic, while devastating, has also created an opportunity for “patients to stand up, educate themselves well and build their expertise,” says Karen Alparce-Villanueva, a board member of the Philippine Alliance of Patient Organizations (PAPO).

She was speaking at a session of the Geneva Health Forum that focused on “Patients as Co-creators and disseminators of innovation.”

She added: “Patients need to realize that we are not merely passive recipients of care but we need to be co-creators and disseminators of information. The more that we know that we are able to participate in policy making.”

But to be achieved during the pandemic, patients must be involved at every stage of a health intervention, from design to evaluation, research to implementation, and from health policy to service delivery, said the speakers panel, which included representatives from three other organizations involved with patient and provider engagement.

The speakers noted that modern patient advocates need motivation, knowledge, skills, attitudes, and the ability to engage in all steps in order to be effective co-designers, co-producers, and co-deliverers of patient centric health systems.

Creating a Patient-Centric Approach – COVID and Beyond

Alparce-Villaneuva and others discussed how the solution to dealing with today’s public health challenges and changing landscape was not to change strategic direction, but to increase patient engagement through a “patient-centric” approach to health.

Neda Milevska Kostova, Board Vice Chair at the International Alliance of Patients’ Organizations (IAPO), said that patients should rather be referred to as “partners”, in order to broaden the scope and the experiences of others.

“It is not only about the health system, because we know that health comes from 20% of the system, and the remaining 80% is related to the way we live,” she said. “Therefore, it’s the patients alone who can bring this extra component that the health system alone cannot encompass.”

A continuous engagement of patients in policy-making would allow true patient participation, added Angela Grezet, of the Association Savoir Patient, who cited best engagement experience in her home country of Venezuela, where she describes her personal experience with doctors “who went the extra mile” to not only diagnose but also explain to her the background of any condition that she might present. 

“I really noticed that [doctors] really tried to understand my situation, and then spent extra time to really explain to me from A to Z, the treatment that they were going to be providing,” said Grezet, who has lived and worked in Europe as well as Latin America.  “We can’t really continue to treat very big health issues without the whole population [being involved].” 

Creating a patient-centric approach is needed to provide better healthcare, speakers argued.
Stigma Over Patient Involvement Persists In Many Health Systems

Despite the apparent benefits, a lot of stigma still exists around patient involvement. This is often an issue in low and middle-income countries where communication is ‘one-way’ between the practitioner and the patient – and it may be less culturally acceptable for patients to challenge the traditional authority of health practitioners, said Bisi Bright, CEO and Founder of the LiveWell Initiative (LWI).

“Empowering [patients] allows them feel safe and not ashamed to be a patient,” noted Bisi Bright, CEO and Founder of the LiveWell Initiative (LWI), describing examples of empowering and training women through crises such as HIV and AIDS. This gives them the confidence to come out and talk about their conditions as expert patients. 

Beyond the current pandemic, fostering a health systems culture of expert patients who are actively involved in their healthcare and health management paves the way towards achievement of universal health coverage, the panelists said.   

Concluded Kostova, “It’s not only about patients but also patient carers, patient advocates… , and this pandemic has shown that it is not only patients but it is everyone, everywhere who can help in improving our lives.”

The Geneva Health Forum runs from 16-18 November. Follow Health Policy Watch’s coverage here and on Twitter.

Image Credits: Geneva Health Forum , Flickr – US Navy.

Developing & rolling out COVID-19 diagnostics has been a key challenge.

Many Geneva-based health agencies have worked together for years to improve global access to diagnostics and treatment, but the COVID-19 pandemic has necessitated much closer collaboration and speedier decision-making.

This is according to experts from the WHO co-sponsored  “ACT Accelerator” medicine access partnership – including UNITAID, the Foundation for Innovative New Diagnostics (FIND), and the Global Fund to Fight AIDS, Tuberculosis and Malaria who appeared today at a session of the Geneva Health Forum.

They appeared together at a session of the Geneva Health Forum with other colleagues from the Swiss Data Science Center of the Swiss Federal Technical Insitute-Lausanne (EPFL) and the European Organization for Nuclear Research (CERN) to talk about what it means to have “Geneva at the Forefront of Epidemic Response.”

Wealthy countries lack the tools to properly diagnose patients.

“Geneva is the epicentre of global health and also innovation,” said Philippe Duneton, Executive Director of Unitaid- a multi-country partnership with the UN system – which is a key channeler of new product innovations into national health systems. He described how his organization’s pre-existing partnerships around HIV and TB had provided a solid platform for collaboration on COVID-19.

“We have been coming together very easily because of the work that we were doing for a long time, ” said Duneton. “But the level of speed, procedure and mastery now is unprecedented.”

Unitaid works primarily through partnerships to channel funds to countries and actors that can help ensure equitable access to innovative health products for the world’s leading infectious disease killers.

Diagnostic Testing: a “Burning Issue”

Ensuring that there are accurate diagnostic tests for COVID-19 has been one of the key challenges for such Geneva-based organisations – and one of the first that was tackled by the formal and informal networks of global health actors.

Diagnostic testing became a “burning issue” during COVID-19 as the deadly disease spread, often silently, and even wealthier countries realized that they lacked the tools to properly diagnose patients, according to FIND’s Emma Hannay. FIND is a non-profit that seeks innovation and delivery of diagnostics to address major diseases.

“Many low, and middle-income countries have access to only the basic tests that you need to be able to care for patients. And even where there is more advanced infrastructure in high-income countries, we have seen countries struggle to be able to respond to the peaks and demands of the pandemic,” said Hannay.

Hannay said she and Duneton had almost daily conversations to address this and other issues since the pandemic began.

“Diagnostics is much less regulated than for other global health commodities. There have been some pretty expensive mistakes made by countries, early on in the procurement of substandard tests,” said Hannay.

“We’ve also seen the emergence of “diagnostics nationalism”, when there have been supply-chain wars over access to diagnostic testing where low-income countries have typically missed out. By the time a diagnostic comes to market, the entire stock might have been reserved by some government.”

To address such issues, the WHO co-sponsored Access to Global COVID-19 Tools, ACT Accelerator, was launched last spring, including Unitaid, FIND and the Global Fund among the key players.

Partners of the WHO co-sponsored Act Accelerator.

Francoise Vanni, Head of External Relations at the Global Fund, said that her organisation’s success is based on “collaborating and joining forces with others”.

“Over the past 20 years, together with our partners we’ve saved, 38 million lives so we know that this approach works,” said Vanni.

Before the pandemic, many of the Geneva-based partners shared a “global health campus”, said Vanni. But the pandemic had forced many of the partners to work at home and to collaborate online.

“What I have had to learn from working online is to listen proactively,” said Vanni.

The Geneva Health Forum runs from 16-18 November. Follow Health Policy Watch’s coverage here and on Twitter.

Image Credits: WHO, University of Washington Northwest Hospital & Medical Center.

Ignazio Cassis, Head of the Swiss Federal Department of Foreign Affairs, at the opening of the Geneva Health Forum.

A mix of strong national measures and international cooperation is needed to solve the COVID-19 pandemic – and the Geneva Health Forum (GHF), which opened on Monday, is showcasing examples of both, said Switzerland’s Foreign Affairs head Ignazio Cassis and Harsh Vardhan, Indian Minister of Health, speaking at the opening session of the three-day event (16-19 November). 

“A coherent approach at the bilateral and multilateral level is needed,” said Cassis. “The GHF has a key role to play. A global crisis needs a global answer. By facing the crisis, we should think globally, act locally and help each other in the spirit of solidarity.” 

Harsh Vardhan, Indian Minister of Health & Family Welfare, at the opening session of the Geneva Health Forum.

“It is imperative to have a multifaceted approach towards collaborations at both the national as well as the international levels,” said Vardhan, Minister of Health and Family Welfare for India, which is co-hosting this year’s GHF event. “I believe that collaborative partnerships could play a pivotal role with inputs from various nations with respect to innovative solutions, supply chain systems, technology transfers, human resources, and more.”

With more than 54 million cumulative cases globally, COVID-19 has upended livelihoods, health systems and societies. But on the brighter side, it has also driven extensive, beneficial and potentially long-lasting changes to health care delivery systems, moving “high quality health care from hospitals into homes and communities,” said Vardhan.

He noted that India’s COVID strategy has emphasised decentralised solutions allowing innovation among individual states, while the shift of health care provision towards digital technologies, helping to strengthen response in the country that has been hard hit by the virus. India’s burden of 8.8 million reported COVID-19 cases is second only to the United States’ 11.1 million infections, so far. However, per capita India’s infection rate is in fact only about one-quarter as high insofar as India has a population of 1.3 billion people – as compared to 328 million for the USA. And India has had only about half as many deaths as the United States.

Map of incidence rate of COVID-19 globally, at 8pm CET, 16 November 2020.

Said Vardhan, “Our decentralized but unified mechanism to provide universal, accessible, equitable and affordable health care to one and all was the driving force behind our response strategy to COVID-19. In the interest of global knowledge sharing, India is willing to share its strategy and know-how.”

Universal health coverage, neglected tropical diseases, sustainable development goals, cancer, the impact of climate change are all to be discussed as major themes at the Forum. However COVID-19 – the reason behind the event’s move this year to a digital platform – will likely dominate conversation.

“COVID-19 has put the spotlight on the important and interdependent nature of public health. In fact, one third of the sustainable development goals (SDG) are health related, and SDG 3 – focusing on good health and wellbeing – is universal and underpins everything we do,” said Tatiana Valovaya, Director-General of UN Office at Geneva, another keynote speaker. “I believe that the participation of 1,600 stakeholders in this forum, connecting from 80 countries is a sure example of the type of inclusive and interconnected multilateralism that we need.”

Tatiana Valovaya, Director-General of the United Nations Office at Geneva.

The goal of the GHF, co-organized by the Geneva University Hospitals (HUG) and the University of Geneva, is to create links between stakeholders, enable the sharing of collective intelligence, and discuss innovative solutions.

Other panelists at the opening session included: Nicole Rosset, Co-President of the Geneva Health Forum, Alexandra Calmy, Vice-Dean of the Faculty of Medicine at the University of Geneva, Shripad Yesso Naik, Indian Minister of State for Ayurveda, Yoga and Naturopathy, and Piyush Singh, Counsellor of the Embassy of India.

The Geneva Health Forum runs from 16-18 November. Follow Health Policy Watch’s coverage here and on Twitter.

Image Credits: Geneva Health Forum, Johns Hopkins.

Dr Tedros warned that the vaccine updates will not solve immediate problems.

The World Health Organization is encouraged by early results of the efficacy of the Moderna COVID-19 vaccine but its most immediate concern is the impact of the surge in cases in Europe and the Americas, threatening both health workers and health systems.

“While we continue to receive encouraging news about COVID-19 vaccines and remain cautiously optimistic about the potential for new tools to start to arrive in the coming months, right now, we’re extremely concerned by the surge in cases we’re seeing in some countries, particularly in Europe and the Americas,” said WHO Director-General Tedros Adhanom Ghebreyesus at the press briefing on 16 November.

“Health workers on the frontlines have been stretched for months. They’re exhausted,” warned Tedros. “We must do all we can to protect them, especially during this period when the virus is spiking and patients are filling hospital beds. At this moment, when some governments have put all of society’s restrictions in place, there is one set game, a narrow window of time, to strengthen key systems.”

WHO has 150 emergency teams in the field assisting countries to plan and implement their responses to the pandemic, added Dr Tedros.

“This is a dangerous virus, which can attack every system in the body. Those countries that are letting the virus run unchecked are playing with fire,” he warned.

Tedros also said that he hoped that the G20 meeting this coming weekend will commit more funds to fighting the pandemic.

While $US 5.1 billion had been committed so far, another $US 4.2 billion is needed urgently and $US 23.9 billion will be required in 2021, said Dr Tedros.

Moderna vaccine results

“There are many many questions still remaining about the duration of action, the impact of severe disease on different subpopulations especially the elderly, as well as the adverse events, beyond a certain period of time,” said WHO Chief Scientist Dr Soumya Swaminathan.

People who are at the highest risk in all countries, particularly health workers who are being disproportionately affected, should have access to a vaccine first, she added. For a more detailed report of the Moderna results, see Health Policy Watch’s story here.

Dr Soumya Swaminathan talks about the Moderna vaccine
WHO Chief Scientist Dr Soumya Swaminathan said there are still many questions remaining.
COVID-19 at WHO HQ

WHO also dismissed reports of a COVID-19 outbreak at its Geneva headquarters (HQ), saying that 5 recent cases have been diagnosed among workers there, but it’s not clear if they were infected in the building or outside.

“There is no outbreak at WHO HQ,” says Dr Maria van Kerkhove, the organization’s COVID-19 technical lead. “Since the beginning of the pandemic, there have been 65 cases at HQ, and 36 cases of staff on the premises.”

Confirming that five HQ staff had been infected in the past week “that are linked together”, Van Kerkhove added that WHO didn’t yet know “if they’re an actual cluster”.

“There are possible ways in which they were infected outside of the premises. So we’re still doing the epidemiologic investigation with these individuals, but they are all doing well,” she added.

Map of cumulative COVID-19 cases globally, at 8pm CET, 16 November 2020.

Dr Michael Ryan, Executive Director of WHO’s Health Emergency Program, added that some of the Geneva staff lived in areas that “have some of the most intense transmission in the world right now”.

“To my knowledge, the cluster being investigated is the first evidence of potential transmission on the site of WHO, but we can’t completely protect ourselves. We are human beings and we live within a society and we’re not entirely within a cocoon here.”

Image Credits: WHO, Johns Hopkins University & Medicine.

Moderna’s mRNA research and innovation centre

Moderna’s mRNA vaccine candidate has had a vaccine efficacy of 94.5%, the company announced today. unveiling the stunning, initial analysis of Phase 3 clinical trial results by an independent Data Safety Monitoring Board, appointed by the US National Institutes of Health. 

And news that the vaccine can be stored at 2° to 8°C (36° to 46°F) for up to 30 days, make the results even more significant for low- and middle-income countries that lack ultra-cold storage facilities required for storage of the other candidate mRNA vaccine, which is being developed by Pfizer, and showed almost as good – 90% results last week – in interim analysis of its Phase 3 trial. .  

The Moderna vaccine only requires a long-term storage temperature of around -20 C° (-4 F°) , in comparison to Pfizer’s requirement of  ultracold storage temperatures of -70 C° or below.  Overall, the data makes the Moderna candidate a prime candidate for vaccine rollout in low- and middle income countries, and even in rural regions of high-income countries that lack ultra-cold storage facilities. 

Last month, Moderna also pledged to “not to enforce our patents” on the COVID-19 vaccine for the duration of the pandemic – meaning that generic vaccine manufacturers could also step in very soon after the vaccine is approved by regulatory authoriities to support massive production. 

According to the company’s press release of the results, of the first 95 adults who developed COVID-19, 90 were in the placebo group of the trial, while only 5 were in the control group of participants who actually received the vaccine.  Among the severe cases, all 11 occurred among people who did not receive the vaccine at all. Moreover, Moderna’s results were obtained from a diverse group of participants, as evidenced by the fact that among the 95 reported COVID-19 cases, there were 15 older adults (ages 65+) and 20 participants identifying as being from diverse ethnic communities, including 12 Hispanic or LatinX, 3 Black or African Americans, 3 Asian Americans and 1 multiracial participant.  There were no significant safety events, and most adverse events were short-lived fatique or mild or moderate headache or muscle pain.

“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, Chief Executive Officer of Moderna.

Stéphane Bancel, CEO of Moderna
Vaccine Stability & Potential Protection Against More Severe Disease Hailed   

Reaction in the health community was swift, albeit cautious.  At a WHO press conference on Monday, Chief Scientist Soumya Swaminathan said that while the results were encouraging: “Of course, we need to wait and see what the final efficacy and the safety profile of this vaccine will be when the whole data is analysed after they reach their primary endpoint.”

While storage temperatures for the vaccine open up the possibility of worldwide distribution in low- and middle income countries, WHO’s Vaccine Depatment head Katherine O’Brien cautioned that the logistics remain formidable: “This is a two-dose vaccine, and certainly any vaccine that can achieve a one-dose vaccine is certainly easier to deliver than a two-dose vaccine,” she pointed out. In addition, most existing vaccine programmes are geared towards children – while this vaccine will first need to be rolled out for adults.

“It is incredibly promising that the vaccines we urgently need are now on the horizon,” said  Charlie Weller, Head of Vaccines at The Wellcome Trust, which has supported COVID vaccine R&D through the Oslo-based Coalition for Pandemic Preparedness (CEPI) funding of vaccine R&D

“To have multiple vaccine candidates with interim results that surpass our expectations is phenomenal, and testament to the incredible global research effort this year….  it is promising to hear Moderna report that doses can be stored at clinics at more regular refrigeration temperatures for up to a month once delivered to healthcare facilities.”

On a more cautionary note, Weller added that while “The results from Phase III of Moderna’s Covid-19 vaccine trial are highly encouraging, however as with other results, we must remember they are interim and we are yet to see the full data. Urgent questions remain to be answered, including how long these vaccines will be effective for, and whether these vaccines work across different populations, in all age groups, ethnicities, and those with prior health conditions.  Only upon trial completion will we be able to assess the full efficacy and safety of any vaccine candidate.

CEPI’s CEO Richard Hatchett also noted that information released by Moderna “suggests that the vaccine may protect against more severe disease  (although they don’t address the statistical significance of this finding), and the reported side effects appear to be manageable. The fact that the vaccine shows stability when stored in a normal refrigerator for up to 30 days is also terrific news and will allow the vaccine to be distributed broadly.

Fair Distribution & Logistics Hurdles: The Next Big Challenges

Once vaccine efficacy is proven, the world will face huge challenges in getting the first doses to the most vulnerable groups around the world – particularly health care workers. 

Adding to that anxiety is the fact that in the case of the first, and apparently high-performing vaccine candidates, like Moderna’s  – rich countries have already  queued up already in line with big pre-orders. 

Moderna has said that through its a collaboration with the Swiss-based company Lonza, it will be able to launch production of up to 1 billion vaccine doses in 2021 at the company’s USA and Swiss sites. By next month, Lonza’s Swiss-based plant in Visp will already be poised to start producing some 300 million doses said Lonza site manager, Torsten Schmidt in an interview last month: “Everything will be ready for the production of the first doses in December.” 

Moderna has also been negotiating with the WHO co-sponsored COVAX facility about distribution through the WHO co-sponsored global procurement network of some 186 countries. The facility promises to secure and distribute sufficient doses to immunize  health workers and at-risk populations first of all. 

But in the press conference today, WHO officials refrained from saying if Moderna had in fact signed an agreement with COVAX – although Wellcome Trust’s Weller indicated that it has saying in his statement: “Moderna’s vaccine is part of the COVAX Facility, which will be instrumental to ensuring any effective vaccines are prioritised for those most in need globally…. ,” but adding, ““It is critical that we urgently and decisively work on the wider issues of Covid-19 vaccine allocation and delivery. Overcoming the logistical hurdles ahead will take unparalleled levels of global collaboration.”

More significant, perhaps, is Moderna’s it’s pledge to not enforce its patents for the duration of the pandemic. That opens up the way for other generic manufacturers to produce Moderna’s COVID-19 vaccine for the COVAX pool.

Tal Zaks, chief medical officer at Moderna

 

Countries Representing Just 12% of World’s Population Hold Options on 78% of Moderna’s 2021 Vaccine Supply

Indeed, production of the Moderna vaccine by generics may become the only way out for the rest of the world since high-income countries, including the United States, the European Union, Canada, Switzerland and Japan, have already made vaccine pre-orders to Moderna for some 300.5 million doses, and have options to purchase another 480 million more – for a total of 780.5 milion out of the 1 billion doses to be produced in 2021.

That would mean that up to 78% of Moderna’s own available vaccine supply next year could be gobbled up by countries representing only 12% of the world’s population, pointed out a coalition of medicines access campaigners in a press release today.

The groups, including the UK-based STOPAIDs, also noted that Moderna has so far received some US$ 2.48 billion in United States government public subsidies, and yet its reported price tag for the two-dose vaccine at $US 50-60 per course is the “highest cited for a potential vaccine so far.”

The coalition called on Moderna to “openly share their vaccine technology so doses can be produced at needed scale, at the lowest possible price.”

In any case, most experts still agree that ultimately, a large pool of effective, but diverse, vaccines will be the best assurance that everyone can get a fair share. Said Weller, “We cannot become complacent. If we are to have enough doses for the entire world and vaccines that work across different groups and settings, we must continue developing and investing in a wide range of [vaccine] candidates.”

However, the innovative mRNA technology being used by Moderna as well as Pfizer still has certain inherent advantages, insofar as it takes less time to develop and also is less bulky in terms of the vaccine volumes. That is becaue the vaccine consists merely of an RNA protein that  “instructs” the body’s own cells to produce the main antigen of the virus. In comparison traditional vaccines typically rely upon an inactivated portion of the virus itself to provoke an immune response.  For more details on the vaccine’s mechanism of action, see our exclusive interview with Moderna Chief Medical Officer, Tal Zaks.

  • Updated 18 November, 2020

 

Image Credits: Moderna, Moderna, Moderna TX.

DataSanté training session in Mali

Third in a series –  Even before the coronavirus struck, large swathes of Africa, as well as parts of South-East Asia and Latin America, still relied on fragmented paper-based medical records, making it difficult to track people’s medical history – and thus provide high-quality treatment and care.

The Virtual Innovation Fair, which is a key feature of this year’s Geneva Health Forum, that began Monday, 16 November, shows how digital health innovations are moving countries into a new era of healthcare, with the creation of digitized personalized medical records that will allow for more systematic follow-up care – not to mention far better disease surveillance. The Fair also showcases some new algorithm-based devices for more precise diagnosis of common conditions like childhood pneumonia. The innovation fair, which will be held from Monday to Wednesday between 12:00-12:30 CET, is open to all GHF participants to chat with innovators about their products. 

There are two particularly promising digital health innovations, both of which will be presented at next week’s Geneva Health Forum, that could help healthcare workers save lives, time, and provide better care for their patients. If all goes well, they could even become the bread and butter of primary health care, and replace paper-based data collection methods forever. 

One of those DataSanté, a seemingly simple, yet highly robust solar-powered software that allows healthcare workers to care for patients of all ages through a digital shared medical record. The second one is IeDA, a slick, Swiss-made job aid tool that enhances the diagnosis of childhood disease, and improves the performance of healthcare workers in real-time through artificial intelligence (AI) algorithms. We took a look at both to see how they work and what impacts they might have on patient care and disease surveillance. 

DataSanté -A Shared Medical Record, Created For Doctors By Doctors 

At first glance, DataSanté may seem quite simple, especially to AI-aficionados. Yet, healthcare workers find it “life-changing”, notes French doctor Pierre Costes, who founded the project almost a decade ago in response to his frustration with digital healthcare in France, as well health data fragmentation in west Africa. 

“Data Sante is a tool we created as doctors, for other doctors and healthcare workers, to simplify their day-to-day work,” says Costes. “It’s quite simple and easy to use, yet it has given rise to a new era.”

Before DataSanté materialized, African doctors in Mali and Benin would lose up to three days a month of potentially life-saving work filling out their Monthly Activity Report – a mandatory administrative report that is almost always prepared by hand. It involves an array of tedious aggregations of patient conditions that were treated, ranging from measures of disease prevalence to vaccination coverage levels, and disaggregated by sex and age,. 

About eight years ago, Coste’s team sought to help doctors do their job and to treat patients more efficiently, instead of spending time writing reports for authorities. 

Today, doctors armed with DataSanté can produce their Monthly Activity Report in no less than one click, saving them up to three days of work. Once their report is ready, all they have to do is to copy the report on paper and mail it to the Ministry of Health.

But automated reports represent only the tip of the iceberg in terms of what DataSanté really does. 

DataSanté’s main aim is to centralize a patient’s medical information in one file through the so-called “shared medical record” – allowing healthcare workers to follow tens of thousands of residents in their region throughout their lives. 

The shared medical records can be simultaneously accessed by nurses, doctors, midwives, or lab technicians, each with their own authentication codes and different levels of authorization.

DataSanté user interface

DataSanté also offers healthcare workers a plethora of handy tools that are tailored to their day-to-day needs and troubles. These include diagnostic support tools, severity alarms, prescription support, continuing education, as well as recall for follow-up care, adds Costes.

Pregnancy Due Date Calculator – Useful Tool For Midwives

The “pregnancy due-date” calculator is a particularly useful tool for midwives. Sometimes, pregnant women that come to the clinic are unaware of their last period, making it difficult to estimate their due-date, which comes about 280 days after their last menstruation. 

Instead, midwives can measure a woman’s uterine height and enter it into DataSanté to quickly estimate her last menstrual period – as well as her due-date. Costes notes that midwives can only use the due-date calculator if they have opened a personalized medical record for each woman, thus ensuring that DataSanté is properly used, without corners being cut.

DataSanté also facilitates teamwork and information-exchange at the local level. If healthcare workers face issues during their workday, they simply click the red alert button on the DataSanté platform and summarize their problem in a sentence, thus alerting the clinic’s head doctor within seconds.

In just four to five days of training, healthcare workers can run the DataSanté package on their tablets, smartphones or laptops. According to Costes, DataSanté can function for dozens of years without requiring a single software update. 

The software can be set up in places that lack internet access through a local server and integrated wifi network, which is either powered through solar energy or a mains power supply of 220 volts.

In Mali, almost three dozen healthcare centers are now equipped with DataSanté. In total, a quarter of a million personal medical records have been created in the three years since the platform was established – and demand is increasing every day, says Costes. 

The NGO has also developed a low-energy version of DataSanté, the “Databox”, for regions that lack electricity. The Databox is as small as a matchbox, with the same functionalities as its larger counterpart, except that it can run on 5-volt supplies. So far, 37 ‘databoxes’ have been installed in Madagascar – and the project aims to expand to Burkina Faso and Niger as well. 

Two years ago, Datasante was presented as an award-winning innovation at the 11th World Convergence Forum in Paris. The project is funded by the Agence Française de Développement.

DataSanté consists of a local server, energy source and tablet

IeDA – A Digital Tool To Diagnose Childhood Illness, With A Few Quirks Up Its Sleeve

In some regions of Sub-Saharan Africa, nearly one child in ten dies before the age of five, often because illnesses like pneumonia, diarrhea or malnutrition are misdiagnosed.

In Sub-Saharan Africa, the most widely used guideline to diagnose children under five is the “Integrated Management of Childhood Illness” (IMCI) algorithm, developed three decades ago by the WHO and UNICEF. 

In countries like Burkina Faso, where half of children die in their first two weeks of life, only 15% of children are correctly diagnosed with IMCI, mostly because frontline healthcare workers fail to adhere to the IMCI algorithm. 

For over ten years, Terre des hommes has refined their solution to optimize the diagnosis of childhood illness. Since the NGO began, its product, IeDA, has gone through twelve iterations.  

Healthcare worker in Niger conducts a consultation with the help of IeDA software

IeDA’s idea is in fact quite simple – it’s a digitized version of the IMCI that can be used on tablets in health centres, using mobile network connections. Its intuitive design, combined with short video tutorials, guide healthcare workers throughout their consultations with children, allowing them to obtain a comprehensive picture of a child’s health. 

Heads of clinics can then visualize the data through simple dashboards to improve the performance of the clinic and to increase the quality of care. The datasets are also sent to Burkina Faso’s Ministry of Health to become an important source of vital statistics, as well as national evidence-based decision-making.

As of August 2020, IeDA has helped undertake 7.5 million consultations, or 200,000 clinical consultations every month, according to a massive 3-year evaluation run by the London School of Hygiene and Tropical Medicine. It has also improved adherence to IMCI by 50%, and reduced unnecessary antibiotic prescription by 7-15%, notes Riccardo Lampariello, Head of the Tdh health programme. 

In Burkina Faso, IeDA has been set up in 1,350 healthcare centres, covering almost two-thirds of the country. If scaled-up to cover the remaining one-third of Burkina Faso, 1.5 million CHF could be saved each year as a result of improved diagnosis and healthcare worker performance, says Lampariello. 

Dr. Robert Kargougou, Secretary General for the Ministry of Health of Burkina Faso

“We have drastically reduced the number of incorrect diagnoses thanks to IeDA and the children benefit from better treatment,” said Dr. Robert Kargougou, Secretary General for the Ministry of Health of Burkina Faso, referring to IeDA. 

But Ministries of Health are not the only ones that are thrilled by IeDA. Healthcare workers are pleased to use the tool because it allows them to quickly finalize monthly reports for authorities, according to qualitative analyses of 21 healthcare workers in 10 primary healthcare facilities. As a result, healthcare workers employ IeDA in 8 out of 10 consultations. 

Sometimes, caretakers even request IeDA because they perceive it as the most accurate option available, says Lampariello. And some communities, like the Boussougou District in the Kadiogo region, have even raised their own funds to gain access to IeDA after hearing about its successes elsewhere.

But IeDA has several other quirks up its sleeve.

Using clever AI algorithms, IeDA can improve the performance of healthcare workers in real-time by anticipating common mistakes, or “bizarre combinations of symptoms”, explains Lampariello.

“In many ways, IeDA is a job aid tool that can detect common errors based on existing clinical data,” he says. “If, for example, a healthcare worker reports high levels of anemia in a region that has historically had low anemia, IeDA will send the healthcare worker a friendly message to check whether anemia has been well measured.“

As the pandemic brings with it a new array of challenges, Terre des hommes’s IeDA has responded through a range of online tutorials to raise awareness on coronavirus prevention and management. IeDA has also developed a triage algorithm to identify and follow up suspected cases of Covid-19, in collaboration with the local authorities. Eventually, the data collected by IeDA may help anticipate new outbreaks with “great precision”, says Lampariello.

Soon, IeDa could also be used in synergy with the Pneumoscope, another promising innovation that will be featured at next week’s GHF. Co-developed by Terre des hommes, it can detect pneumonia in less than seven minutes.

With financing from The Global Fund, Terre des hommes is in the process of handing IeDA over to Burkina Faso’s Ministry of Health. The NGO is also piloting IeDA in Niger, Mali, and plans to expand to India’s state of Jharkhand next year. 

Childhood diseases like pneumonia kill nearly 10% of children below the age of five in Sub-Saharan Africa, often due to misdiagnosis

Big Challenges For Digital Health Still Remain – Both Technical & Human 

In past years, smartphone ownership and internet coverage on the African continent has increased exponentially, but there is still a long way to go – especially in rural regions where coverage, bandwidth, and smartphone ownership is still low, note Lampariello and Costes.

For digital health to be successful, considerable ‘human challenges’ also need to be addressed, says Costes. Local leadership is needed, he adds, noting that sometimes, when new heads of clinics are appointed, they are less motivated to use DataSanté, letting their clinic backslide into old-fashioned methods.

Users also need to take ownership of the digital health tools that are created for them – and demand changes when they are needed, so that digital health stays relevant and useful. 

“Some healthcare professionals have not yet taken ownership of this software [DataSanté],” says Costes. “They are not aware that this is their own system. They can, and should ask for changes to keep control of DataSanté. 

If healthcare workers fail to take ownership of digital health tools, national authorities could take over, and instead appropriate DataSanté to serve their own interests, which are sometimes misaligned with those of healthcare workers, warns Costes. 

While DataSanté’s door is “open for dialogue” with health ministries, it can be challenging to harmonize between the priorities of healthcare workers and ministries of health, he adds. 

According to Costes, digital health’s primary objective should be to serve its users. The needs of decision-makers are important, but they should come once the groundwork is laid.

Image Credits: Terre des hommes, DataSanté, DataSanté , Researchgate, Our World in Data.

Smart Scope cervical cancer screening campaign in rural India

Second in a series – On Wednesday, 18 November, at 2pm CET, leading experts at the Geneva Health Forum (GHF) 2020 will provide their take on how to move forward on the recently approved WHO global strategy to accelerate the elimination of cervical cancer, which kills 300,000 women every year, mostly in low-resource settings like India.

The Indian-made Smart Scope, which will be featured at the Forum’s virtual Innovation Fair, could be a key tool in the battle to put an end to cervical cancer. The Smart Scope can detect cervical cancer in less than ten minutes, making it ideal for mass screening programmes in rural settings. The innovation fair, which will run from from Monday to Wednesday between 12:00-12:30, is open to all GHF attendees to chat with innovators about their products.

Cervical cancer is deadliest in low- and middle-income countries.

In India alone, cervical cancer claims the lives of 100,000 women a year, making it the second largest killer of women in the country after breast cancer. Unlike other countries that have set up an organized cervical cancer screening strategy and mass-vaccination against Human Papilloma Virus (HPV), India has remained largely silent on the issue, noted a recent study by the University of Nebraska. 

“There is no organized cervical cancer screening programme and no national policy for HPV prevention in India – screening of asymptomatic females is practically non-existent,” warned researchers.

In 2020, HPV vaccine coverage in India is still low, and prices are out of reach for the average Indian, at $160 for three doses, according to researchers at the University of Nebraska.

Mass screening for cervical cancer is another issue. The most commonly used test, the pap-smear test, is invasive, requires significant expertise to analyze, and out-of-reach for rural Indians, who account for two-thirds of India’s overall population.

Even if women from rural settings are able to reach distant clinics to get their pap-smear, the test takes four to five days to be processed. As a result, many women do not return for follow-up because they cannot afford to take another day off from work.

Periwinkle Technologies, a company based in Pune, India and supported by the nation’s Department of Biotechnology, offers a practical, portable and affordable solution to detect cervical cancer in a single visit – the ‘Smart Scope’.

The Smart Scope is an affordable handheld device that can be linked to a tablet

The Smart Scope is a non-invasive pencil device that can detect cervical abnormalities in less than ten minutes, with the aid of a tablet and an intuitive app. The test result is color-coded and supplemented by a visual report. Users find it “extremely” easy to use and to interpret, says Veena Moktali, founder of Periwinkle Technologies.

Given the device does not require specialized equipment or electricity, it can reach rural communities, especially during mass-screening programmes, which form a cornerstone of the country’s health promotion strategy. In one day, the Smart Scope can screen up to 60 women, says Moktali.

The AI-powered Smart Scope diagnoses cervical cancer with a sensitivity of 80 to 85 per cent, which is almost double that of the pap-smear test in some cases – where laboratory equipment or expertise may be spotty. 

Smart Scope Campaign in Indian clinic

Since March 2019, over a hundred Smart Scopes have been installed in healthcare facilities in various states across India. Together, they have screened more than 5,000 women, of which 5% had precancerous cervical conditions and 30% had benign HPV infections, according to an impact analysis by Periwinkle Technologies, the Tata Memorial Center as well as Deenanath Mangeshkar Hospital. A study of the device’s efficacy has been accepted for publication by Asian Pacific Journal of Cancer Prevention (APJCP).

Earlier this year, the Smart Scope won the Startup Grand Challenge competition organized by the National Health Authority. Last month, the government began a market access programme to expand the Smart Scope’s reach. 

But the Smartscope is much more than a cancer-detection tool. Rather, it offers women a comprehensive assessment of their cervical health because it can distinguish between pre-cancerous cells, cancerous cells, various types of infection, or even other benign abnormalities. In contrast, a pap-smear provides a limited result that is either “normal”, “unclear” or “abnormal”.

The visual aspect of the report enables patients to see their diagnosis with their own eyes, lending the result more credibility, adds Dr. Varsha Singh, who is the Head of Clinical Studies and Institutional Partnership Programs at Periwinkle Technologies. In contrast, the pap smear’s “text-only” result is rather difficult to communicate to patients, and is even ignored in some cases.

With the aid of a visual report, women can also show their results to family members, which is crucial for a disease that is poorly understood and deemed to lead to extra expenses for households.  As a result, the Smart Scope is more likely to bring women back for follow-up and treatment than the pap-smear. 

Why The Smart Scope Works  

Technicians have screened more than 5000 women in India with the Smart Scope

During the design of the Smart Scope, Periwinkle Technologies quickly understood that the speed of diagnosis was essential to their product’s success.

Busy doctors, especially in rural regions, were often “very reluctant” to spend time sterilizing medical equipment through a lengthy process called autoclaving, which can take up to 45 minutes. And during mass-screenings, women seemed unwilling to get tested when procedures were time-consuming or required a second follow-up visit to get their results. 

“When we used to work with the doctors in rural settings, we saw that autoclaving medical equipment was a big hurdle during mass-screening camps,” says Dr. Singh. “ In addition, patients were reluctant to come for screening as it requires a second visit to get the report. Thus, it was from users’ feedback that we found that there is a requirement to do the testing very efficiently and quickly.”

In response, Periwinkle Technologies designed a disposable sleeve that lies between the Smart Scope’s camera and a patient’s cervix. This allowed doctors to quickly dispose of the sheets between consultations, and to serve as many women as possible without the need for a lengthy sterilization process like autoclaving. 

Although the Smart Scope’s makers are technology providers, they are also heavily focused on outreach to improve awareness of cervical cancer and to fight stigma, in collaboration with local partners.

As well as having launched their own blog on gynecological health, Periwinkle Technologies regularly host training sessions, workshops, conferences and online courses for gynecologists, physicians, nurses as well as midwives. So far, 45 training sessions have been conducted, with 50 to 200 participants at each session.

During their outreach, Periwinkle Technologies frame the Smart Scope very carefully. Instead of describing it as a cancer screening device, it is introduced as a tool that ensures cervical health – as any mention of cancer usually scares people away, says Moktali.  Link here to register for the Geneva Health Forum and join the Virtual Innovation Fair

-Veena Moktali and Dr. Varsha Singh contributed to this story.

Image Credits: Periwinkle Technologies, The Lancet.