Women wait to be screened by Illumigyn's Gynescope in Qalansawe, Israel.
Women wait to be screened for cervical cancer using a new digital device at a discreetly placed mobile station, in Qalansawe, Israel.

Qalansawe, Israel – The women, heads covered in hijabs, sat outside a small purple aluminium mobile health station parked in a residential neighbourhood here, shooing away any men who happened to pass by.

Plastic chairs formed a small and intimate circle for the women waiting to be screened for cervical cancer – some for the first time ever, and others who had skipped their annual screenings for decades.

Once inside the mobile station, the women were greeted by a female nurse with a digital scope not much longer than the palm of her hand with a full HD camera at the top.

The Gynescope, which is produced by Israeli firm Illumigyn, digitally documents the cervix, vagina and external genitalia, using high-resolution and superior magnification.

It doesn’t need a fancy lab setup and can produce results within minutes. The digital cervical footprint is saved to the cloud and can be used for remote diagnosis, ongoing medical supervision and follow-up consultations.

“I do not have specific numbers,” Dr Gasem Jauousi, head of family medicine for the city’s largest health fund, told Health Policy Watch. “But Arab women get screened less than the Jewish women. They are less connected [to the health system]. If we do not call, they won’t come.”

Janousi, who spoke from his office adjacent to the caravan, is one of the lead collaborators in a field trial of the Gynescope, one of the latest of the new generation of cervical cancer screening tools that are easier diagnosis for the disease that killed more than 340,000 women in 2020, according to the World Health Organization.

Smart-Scope pencil-like device

The Indian-developed Smart-Scope device and monitoring screen can fit into an A-4 sized computer bag

Other devices include the handheld Indian “Smart-Scope” which will be feature in the innovation fair of the Geneva Health Forum 2022 (3-5 May). The Forum also is hosting a special day-long meeting on innovations in cervical cancer screening and care, Wednesday 4 May.

The Smart-Scope is an even smaller and more portable device, can detect cervical abnormalities in less than 10 minutes using artificial intelligence, with the aid of a tablet and an intuitive app, Veena Moktali, the founder of the Indian start-up Periwinkle Technologies, told Health Policy Watch.

The test result is color-coded and supplemented by a visual report, Moktali explained. The Smart-Scope stores data on a tablet not the cloud, which makes it accessible to clinics without internet access.

Key features of these new devices is their reliance on high-quality digital imagery instead of old-fashioned lab smear samples that entails taking a sample from a woman’s cervix which then has to be analyzed.

The digital storage of images makes for easy referral and portability, and mobile health clinics can offer the service to women who may not otherwise come to a clinic for a screening test, said Moktali.

Moktali is also speaking at the Geneva Health Forum hosted meeting on cervical cancer about how new AI devices like the Smart Scope are enabling improved point-of-care screening for cervical cancer. The full-day workshop, which evolved out of interactions by innovators and health care professionals at the biennial GHF meetings, will look at how new devices and strategies for cervical cancer screening and treatment can advance the World Health Organization goal of eliminating cervical cancer by 2030.

Solutions for harder-to-reach communities

While Israel is a high-income country with a strong public health system, more marginalized communities – including new immigrants, African asylum seekers, and Arab-Israeli citizens – can fall through the gaps of routine checks.

This is especially true when it comes to sensitive medical interventions such as cervical cancer screening around which there may also be cultural taboos.

For several decades, routine screening for cervical cancer has involved a “Pap smear,” a procedure developed in the 1920s by Georgios Papanikolaou and Aurel Babeș.

A trained health worker scrapes a woman’s cervix for a cell sample, which is then relayed to a laboratory for analysis by a trained technician seeking abnormalities that could indicate cancer or a precancerous growth.

Aside from needing laboratory and diagnostic capacity that is unavailable in many parts of the world, many women find Pap smears invasive and uncomfortable.

Over two days in March, Illumigyn in collaboration with the government health-fund Clalit, set up caravans in two disadvantaged Israeli neighborhoods, one of them Qalansawe. Clalit contacted women enrolled in the health fund, who had not previously been screened, and invited them to come for a visit. No appointment was needed.

Digital image of cervix illuminated on a Gynescope

The women were able to enter the mobile clinics, positioned in a fenced-off area near the neighborhood health clinic, and be screened by a female nurse. The image was sent to their doctors in real time to inform the women if further evaluation or other action was required.

“They told me to go to the hospital and get an ultrasound,” one woman, who asked to remain anonymous, told Health Policy Watch as she left the caravan. “I need to follow up,” she added, saying that she intended to follow their advice.

Another woman, who also asked to be anonymous, said that when she came to the mobile station, she didn’t even know what the check was intended to diagnose.  Her experience raised her awareness about the whole cervical cancer issue:

“I had no idea what to expect,” she said. “But I am told this is a good thing, that it could save lives, God willing. … Doing these screenings, thinking about people and worrying about them. It is really good,” she said, after leaving the mobile station, full of praise for the initiative.

“We know that women are busy – we don’t have time,” said Illumigyn vice president Yam Salman. “Especially women who are raising their families. But women want to live and now we have the technology that can help them do so. Illumigyn can save their lives,” she said.

Eliminating cervical cancer

Cervical cancer claims the lives of around 300,000 women each year, one woman every two minutes, according to WHO.

At the same time, the disease is highly preventable either by being vaccinated against the human papillomavirus (HPV), which causes the majority of cervical cancers, or by early detection through screening.

Most cervical cancer deaths now occur in low- and middle-income countries where fewer girls are vaccinated and women don’t get regularly screened.

In 2020, the World Health Assembly adopted a global strategy to eliminate cervical cancer, with weighty targets to be hit by 2030. The strategy focuses on three aims: vaccinating 90% of all girls against HPV by the age of 15; expanding access to screening services for 70% of women; expanding access to treatment for 90% of women with precancerous lesions; and offering palliative care for 90% of women with invasive cancer.

Smart Scope cervical cancer screening campaign in rural India

“Cervical cancer is the fourth most common cancer among women globally, but it is almost completely preventable and, if diagnosed early enough, is one of the most successfully treatable cancers,” said WHO’s Director General Dr Tedros Adhanom Ghebreyesus on Cervical Cancer Elimination Day in 2021.

“Like COVID-19, we have the tools to prevent, detect and treat this disease. But like COVID-19, cervical cancer is driven by inequitable access to those tools,” Tedros said.

The COVID pandemic has slowed progress to eliminating the cancer, but the new, low-cost screening measures that “democratize women’s health care” can help change that, argues Salman.

New AI devices can be used by any trained caregiver

Both the Smart-Scope and the Gynescope can be used by any trained caregiver or a nurse practitioner, allowing women to be screened and diagnosed even in locations where doctors may be unavailable or in short supply.

That is significant, insofar as around two-thirds of cervical cancer deaths now happen in low- and middle-income countries or communities, explains Dr Nomonde Mbatani, a gynaecologist at Groote Schuur Hospital in Cape Town, South Africa.

Women in rural settings also have a tough time taking off a day of work to reach distant clinics to get their Pap smear. And, if they do take off for the screening, they are unlikely to take a second day off to return to the clinic to get their results – which take several days or even longer to produce.  And that makes follow up action even more difficult, she said in an interview with Health Policy Watch.

“Sending them home is not ideal. The ideal is where their results can be readily available on the same day,” Mbatani said.

Awareness and cultural barriers also exist, she added.

“There is very little understanding of how cervical cancer is caused,” Mbatani said. “Some women feel uncomfortable about presenting problems they are experiencing in their lower genitalia or even having it looked at by a male doctor, except when it comes to birthing their children.”

Resistance to HPV vaccines

Along with better and more frequent screening of adult women, vaccination of pre-adolescent girls against the human papillomavirus virus (HPV), a leading cause of cervical cancer, is another important strategy being touted by WHO for eliminating cervical cancer.

South Africa, which has one of the best health systems in Africa, routinely offers the vaccine to young children in public schools, Mbatani said, noting the vaccines have been availalbe in the country for about a decade already. But any girl living in a rural area who does not regularly attend school may still miss out.

In addition, parents of children enrolled in the country’s extensive private school system have to “opt-in” and request that a doctor vaccinate their children in a private clinic, making immunization rates among these youths much lower.

“In public schools, they opt out rather than in,” Mbatani said.

More frequent exams are important

In South Africa, women are only recommended to get a Pap smear once in every 10 years.  It’s too long between examinations, Mbatani says.

WIth screening every 1-3 years, there is a 95% chance that any developing cervical cancer will be caught in time and can be treated. With screening every 10 years, the reduction of cancer risk drops to about 66%.

“That is not ideal, but to make this available to most women is better than not doing anything,” she said. “WHO suggests if women could even have one Pap smear once in their lifetime this could still reduce cervical cancer. The problem is that screening is opportunistic and not everyone takes advantage of that opportunity.”

Over time, it is hoped that the new AI devices can help overcome some of the barriers that Mbatani describes – allowing for better integration of cervical cancer screening into more routine, primary health care services that are already offered for women’s reproductive health or HIV/AIDS prevention and treatment.

As Salman says: “Why do we need to die from something that can be prevented?”

Image Credits: Illumigyn, Periwinkle Technologies , Illumigyn , Periwinkle Technologies.

A child is vaccinated against measles at the DFID and UNICEF-supported Nutrition Health Centre in Hargeisa, Somaliland on 3rd February 2021.

A 79% rise in the reported measles cases in the first two months of 2022, compared to the same period last year, has raised concerns over the possibility of an outbreak that could affect millions of children this year. 

Pandemic-related disruptions, increasing inequalities in access to vaccines, and the diversion of resources from routine immunization have created the ‘perfect storm’ of conditions for a measles outbreak, WHO and the United Nations Children’s Fund (UNICEF) warned on Wednesday. Children are not only at risk of being infected with measles –a disease which is preventable through vaccination– but also other vaccine-preventable diseases. 

Risks of a bigger outbreaks have also been heightened by the relaxation of social distancing norms in communities around the world, along with the mass displacement of people, including many children, due to conflicts and crises in countries ranging from Ukraine, Ethiopia, Somalia and Afghanistan.  

Some 17,338 measles cases were reported worldwide in January and February 2022, compared to 9,665 during the same period last year, said WHO and UNICEF. The possibility of underreporting looms large as the pandemic has disrupted global surveillance of cases and vaccinations. 

23 million children have missed out on basic vaccines  

There is rising concern over children becoming more susceptible to other vaccine-preventable diseases too.  Some 23 million children have missed out on basic childhood vaccines through routine health services in 2020. This is the highest number since 2009 and 3.7 million more than in 2019.

As of April 2022, 57 vaccine-preventable disease campaigns in 43 countries that were scheduled to take place since the start of the pandemic are still postponed, impacting 203 million people, most of whom are children, WHO and UNICEF said. Of these, 19 are measles campaigns, which puts an additional 73 million children at risk of measles due to missed vaccinations. In Ukraine, the measles catch-up campaign of 2019 was interrupted firstly by the COVID-19 pandemic and more recently, by Russia’s recent invasion.

“It is encouraging that people in many communities are beginning to feel protected enough from COVID-19 to return to more social activities. But doing so in places where children are not receiving routine vaccination creates the perfect storm for the spread of a disease like measles,” said Catherine Russell, UNICEF Executive Director.

According to Dr Tedros Adhanom Ghebreyesus, Director-General of the WHO, the disruptions caused by the COVID-19 pandemic in immunization services for many other diseases will be felt for decades to come. “Now is the moment to get essential immunization back on track and launch catch-up campaigns so that everybody can have access to these life-saving vaccines.”

Humanitarian crises disrupting vaccination programs 

In  2017-2019, there were over 115,000 cases of measles and 41 deaths in Ukraine which was the highest incidence in Europe.

Top 5 countries with reported measles cases in the last 12 months, until April 2022

Along with Ukraine, humanitarian crises in Ethiopia and Afghanistan are seriously disrupting vaccination programmes for measles and other diseases. 

Three of the five countries globally with the highest measles cases so far this year – Somalia, Ethiopia and Nigeria – are in Africa. Afghanistan and Yemen are the other two countries whose caseload of measles puts them in the top five countries burdened with measles. 

Because measles is one of the world’s most highly contagious infectious diseases, it has a high threshhold for herd immunity, meaning that vaccination rates need to be particularly high to prevent outbreaks. “When vaccination drops, measles is typically the first childhood disease to have an outbreak.” Andrew Noymer of the University of California was quoted as saying in an article on Ethiopia’s measles outbreak, published in The Lancet Infectious Diseases’ May 2022 edition. 

In the first three months of 2022, there were 2,156 confirmed cases of measles and 2,755 suspected cases, WHO’s Regional Office for Africa has reported. The vaccination status of 40% of the suspected cases was not known. The measles outbreak in Ethiopia comes at a time when the country is facing a complex humanitarian and armed conflict that has led to a high number of refugees and internally displaced people.  Other measles outbreaks are occurring in Chad, Congo, the Democratic Republic of Congo, Guinea, Liberia, Mali. Mozambique, Niger and Nigeria, Sierra Leone, South Sudan, and Togo, with thousands of confirmed cases and tens of thousands of suspected cases across the continent, WHO said. 

Measles also is known to weaken a child’s immune system and makes them susceptible to other infectious diseases like pneumonia and diarrhoea, the WHO and UNICEF said. At population level, vaccine coverage at or above 95%, with two doses of the safe and effective measles vaccine, can protect children against measles outbreaks.

Image Credits: UNICEF, UNICEF , UNICEF/WHO.

health misinformation
Mike Ryan, Executive Director of WHO Health Emergencies

Following the purchase of Twitter by billionaire Elon Musk on Monday, the World Health Organization warned about the dangers of health and vaccine misinformation on social media, and expressed hope that the acquisition would lead to an ‘improvement of quality information’. 

“There is misinformation and disinformation out there across whatever platform you wish to go to. The good stewardship of these platforms is extremely important,” said Mike Ryan, Executive Director of WHO Health Emergencies, in response to a reporter’s question at a media briefing Tuesday afternoon.

“Anyone who reaches a position in life where they have so much potential influence over the way information is shared with communities takes on a huge responsibility. We wish Mr. Musk luck with his endeavors to improve the quality of information that we all receive.” 

Musk purchased the social media platform Twitter in a $44 billion deal, sparking concern and fear for free speech on the site. 

While Musk has called himself a free speech absolutist and has criticized Twitter’s moderation, political activists expect that this means less moderation and reinstatement of banned individuals including former US President Donald Trump – which has led to cheers from conservatives and concerns that this may lead to a rise in hate speech and misinformation. 

WHO maintained that it engages with platforms such as Twitter in order to disseminate the best possible health and vaccine information. 

‘Critical’ that health information across social media remains ‘credible’ 

WHO Director of Immunization Kate O’Brien

WHO also emphasized the ‘critical’ nature of accurate health information, especially when it comes to life-saving vaccines. 

Added WHO Director of Immunization Kate O’Brien: “People’s lives are lost as a result of misinformation or intentional incorrect information. It’s just incredibly critical on vaccines and on other health issues that people are seeking credible information from credible sources.” 

She stated that this matter was not just “chatter on social media channels” and emphasized the role that social media played in conveying information to the public.

“It really has an impact on what people do, what people chose to do, what they chose to do for themselves, for their children, for their families.”

“It’s something we really take seriously. We have to recognize that for a vast majority of people, they [need to] understand the value of vaccines, they understand the frankly life-threatening risks of the diseases against which we have life-saving vaccines [for], and are seeking vaccines and getting vaccinated.” 

ebola
Healthworkers during the 2017 Ebola outbreak in the DRC.

The World Health Organization has announced an outbreak of Ebola in the Democratic Republic of Congo and its continued investigation of almost 200 cases of unexplained acute hepatitis in the US and Europe in a media briefing Tuesday afternoon. 

Two cases of Ebola have been confirmed in the northwestern Democratic Republic of Congo, prompting health authorities to declare an outbreak.

The cases were found in Mbandaka, a city in the northwestern Equateur province of DRC. The second case, confirmed yesterday, was a relative to the first patient. 

Both patients have died from the virus.

The densely populated nature of the city of Mbandaka has WHO “concerned” about possible spread of transmission.

“It is always concerning when an area like Mbandaka, with the density of the population, but also with the risk of [Ebola] spreading across the river to countries like the Central African Republic,” said Ibrahima Soce Fall, Assistant Direct-General for Emergencies Response. 

WHO is supporting DRC’s government to scale-up testing, contact tracing and public health measures. Stockpiles of Ebola vaccines in the cities of Goma and Kinshasa are being transported to Mbandaka so that vaccination can start.

“The government and people of DRC have a great deal of experience stopping Ebola outbreaks and WHO will support them to do whatever is needed,” said Director-General Dr Tedros Adhanom Ghebreyesus.

The two outbreaks of Ebola in the DRC were reported in 2021, one in February and another in October, though both were declared over within months. 

Acute hepatitis may be linked to adenoviruses

Philippa Easterbrook, Senior Scientist in the Global Hepatitis Programme at WHO

WHO is currently investigating the origin of 169 cases of acute hepatitis that have been reported in 12 countries across Europe and in the United States in children aged one month to 16 years. 

Some of these cases have been reported to be confirmed or suspected to be ill with the mysterious and potentially deadly disease since January. 

17 children – about 10% of reported cases have required liver transplants. One has reported several acute hepatitis, with symptoms including abdominal pain, diarrhea, vomiting, jaundice, and increased levels of liver enzymes. 

However, the virus that commonly causes acute viral hepatitis has not been detected in any of these cases, with no virus being detected in at least seventy-four cases. 

Philippa Easterbrook, Senior Scientist in the Global Hepatitis Programme at WHO, pointed to a possible link to adenoviruses, a common infection in children, as an underlying cause. 

Adenoviruses are a group of common viruses that spread from person to person and can cause respiratory gastrointestinal infections, especially in children. However, the report of adenoviruses in around 74 of reported cases has been called “unusual”. 

“It is very unusual for an adenovirus to cause these types of severe symptoms,” said Easterbrook.

Image Credits: WHO.

The precipitous drop in COVID-19 testing across the world since January has made it harder to track the evolution of variants, and is also undermining the potential of new antiviral drugs that have to be taken early to be effective.

Testing was a major focus of Tuesday’s meeting of the Access to COVID Tools Accelerator (ACT-A) facilitation council and the World Health Organization (WHO) media briefing that followed, which celebrated the publication of the Accelerator’s two-year impact report.

The ACT-A was created to develop and equitably deliver vaccines, therapeutics and diagnostics to those that need them the most, and the global vaccine delivery platform, COVAX, is its most renowned component.

“As many countries reduce testing, WHO is receiving less and less information about transmission and sequencing. This makes us increasingly blind to patterns of transmission and evolution. But this virus won’t go away just because countries stop looking for it,” chided WHO Director-General Dr Tedros Adhanom Ghebreyesus at the media briefing.

Earlier, he had told the council meeting that “low-income countries are testing at an average of two tests per day per 100,000 population. This is over 100 times lower than the testing rate in high-income countries.”

“In the last four months in the midst of Omicron, as cities in East Asia go on lockdown and vaccination rates stall, testing rates have plummeted by 70 to 90% worldwide,” added Bill Rodriguez, CEO of the Foundation for Innovative New Diagnostics (FIND). 

Limited access to new antivirals

Last Friday, the WHO approved Pfizer’s Paxlovid antiviral – a combination of nirmatrelvir and ritonavir – for patients with mild or moderate COVID-19 at high risk of hospitalization. But Paxlovid needs to be taken within three to five days of infection to be effective – which means access to testing.

While COVID-19 therapeutics hold a lot of promise, “there are some caveats and considerations around these treatments, particularly given the need to align with testing strategies and given those very testing strategies and rates are so low”, Loyce Pace, US Health and Human Affairs Assistant Secretary for Global Affairs, told the council.

MPP licensees for COVID treatments, April 2022

The Medicine Patent Pool’s (MPP) Charles Gore told the council meeting that generic versions of Paxlovid were only likely by the end of the year.

He added that the MPP, which has an agreement with Pfizer to license generic producers to make Paxlovid for 95 low and middle-income countries, “cannot give a licence unless somebody applies for one” and when a company did apply “they’ve got to be able to meet our quality standards”. 

The MPP had offered two licences to companies in Africa, “but they for various reasons declined to sign the licences”, he added

“There is a clear gap here in terms of promoting and supporting companies to be able to get to a standard where they can apply for licences, so that we have the most geographically dispersed manufacturing base that we can have in order to ensure this sort of supply security that we’ve been talking about so much in vaccines,” added Gore.

ACT-A achievements

Seth Berkley

Despite the ongoing issues, various speakers lauded the ACT-A’s achievements.

COVAX has delivered over 1.4 billion to date across 145 countries worldwide, with Seth Berkley, CEO of Gavi, The Vaccine Alliance, calling it the “largest and most complex global vaccine rollout in history.” 

It has also enabled 40 countries to begin their COVID-19 vaccination campaigns, helped build the sequencing capacity in Southern Africa that first detected the Omicron variant, and negotiated unprecedented deals with the world’s largest oxygen suppliers to increase access in more than 120 low- and middle-income countries. 

But in spite of these accomplishments, Berkley noted: “We still have plenty to do.” 

While 44% of people in lower-income countries have now been vaccinated with at least two doses of a COVID-19 vaccine and global coverage is 59%, the global vaccine equity gap is still too wide, said Berkley. 

There are some 18 countries that have only protected 10% or less of their populations.

A  key criticism of the ACT-A in the first year of its operation was that it took COVAX too long to buy the mRNA vaccines  because it lacked the cash to compete with rich countries’ pre-market commitments to Pfizer, Moderna and Johnson & Johnson. 

“The good news is that today we have access to as much supply as countries need to meet their national targets,” said Berkley. “That means that countries in turn can plan large scale rollouts with confidence that the doses they have requested. will arrive on time, including usually with our product of choice. 

“But we cannot ignore the fact that many country’s health systems lack the capacity to simply switch on massive vaccination programmes alongside the other vital routine immunization services,” he added.

To address this Gavi has already made $600 million available for COVID delivery support to lower-income countries.

First steps towards a pandemic contingency fund 

Loyce Pace

Berkeley also said that Gavi is creating a “pandemic vaccine pool” that could respond more quickly in the future. 

A Gavi/ ACT-A pledging event on 8 April that raised $4.8 billion earlier this month, was the first step towards that ambition, said Berkley. 

“Our donors stepped up and helped us launch a contingent financing facility that will help us ensure that when the need arises, and COVAX can step up and order new doses immediately,” he added.

While COVAX may not be fully funded, “this is still in stark contrast to 2020, when we first had to raise cash before we could place any orders, and it’s a sign of how far we have come as a multilateral solution, not just in helping address the challenges of this pandemic, but leaving us better prepared for the next one.” Berkeley said.     

To rally the global community to support the flagging vaccination drive, a global COVID-19 summit co-hosted by the governments of Belize, Germany, Indonesia, Senegal and the US will be held on 12 May.

“We are inviting ambitious policy or financial commitments for that particular engagement. It’s going to be very important for all of us to come up with a new set of commitments that will help continue to drive this change and ensure that we are closing the gap and reaching those most in need or and most often left behind,” said Pace.

We’re particularly focused on locally-led solutions and opportunities.”

Image Credits: UCT.

A premature baby in the neonatal unit in Nelson Mandela Children Hospital in Johannesburg, South Africa.

More newborn babies with sepsis are dying because their infections are not responding to the usual antibiotics, according to the biggest global study on the subject yet.

The study’s sponsor, the Global Antibiotic Research and Development Partnership (GARDP), is now designing an interventional trial to identify better treatment regimens. to combat rising resistance.

GARDP’s study, which involved over 3200 newborns diagnosed with sepsis in 11 countries, was released at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) on Tuesday.

It found that many physicians were forced to use last-line antibiotics such as carbapenems due to the high degree of antibiotic resistance in their treatment units. 

Last-line antibiotics were prescribed to 15% of babies enrolled in the study. Overall, 11% of the newborns died over the course of the study – but there was huge variation between countries and hospitals.

In 2019, nearly 1.3 million deaths – including nearly 140,000 deaths of newborns – were caused by bacterial antimicrobial resistance (AMR).   

Major threat to newborns

“Our study has shown that antibiotic resistance is now one of the major threats to newborn health globally,” said Mike Sharland from St George’s, University of London and the principal investigator. 

“There are virtually no studies underway on developing novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections. This is a major problem for babies in all countries, both rich and poor. 

The World Health Organization (WHO) recommends the standard antibiotics – ampicillin plus gentamicin – for the treatment of neonatal sepsis, but the study showed that many hospitals are using other combinations due to high levels of resistance to the WHO-recommended treatment.   

But the use of antibiotics varied noticeably across sites in Bangladesh, Brazil, China, Greece, India, Italy, Kenya, South Africa, Thailand, Vietnam and Uganda, “with many different antibiotic combinations being used, often without any underlying data”, according to GARDP.  

Okwenathi Sibango, born prematurely at six and a half months, was one of the babies enrolled in the study. After fighting off an intestinal infection, the tiny boy, who weighed less than a kilogramme, picked up a life-threatening antibiotic-resistant infection in the hospital. He also developed meningitis and his doctors had to treat him with antibiotics of last resort.

“Over the past decade we have a seen a year-by-year increase in antibiotic resistance,” says Dr Angela Dramowski, Clinical Head of General Paediatrics at the Cape Town hospital that treated Sibango.

“We urgently need new antibiotic options. We are also hopeful that the study by GARDP and partners will go far in working out the best treatment options for babies, with the right dose and the least possible toxicity. This will help us in treating babies like Okwenathi.” 

Testing new antibiotic combinations

The GARDP trial will test the safety and effectiveness of three potential new antibiotic combination treatments, ranking them against existing commonly used antibiotic regimens for neonatal sepsis. It will also look into the comparative efficacy of other approved but less common antibiotics and describe local patterns of antibiotic resistance.

It starts in Kenya and South Africa later this year and will expand to up to eight other countries next year.   

“There is an urgent need to develop and ensure access to novel antibiotic treatments to keep pace with rising rates of drug-resistant infections among babies with neonatal sepsis,” said GARDP Executive Director Manica Balasegaram.

 “We are incredibly grateful to our numerous partners and funders who have given us essential support to make this observational study possible. Guided by these new insights, we have the opportunity to place children at the centre of the international response to antibiotic resistance.”  

Image Credits: 20 May 2021South AfricaKL Schermbrucker/GARDP.

UNICEF’s Global Supply and Logistics Hub in Copenhagen

CAPE TOWN – As the health sector celebrates World Immunisation Week, one of the most pressing related problems is Africa’s almost total dependence on imported vaccines –  something that predates, but was highlighted by, the COVID-19 pandemic.  

But addressing this dependence will mean dismantling the ‘charity’ model that has underpinned many of Africa’s immunisation programmes over the past two decades at least – since the creation of Gavi, the Vaccine Alliance.

The terrible price of Africa’s vaccine dependence was brutally highlighted a year ago at the height of the Delta period of the COVID-19 pandemic. India banned the export of vaccines produced by its generic companies. Western countries bought up the limited international global supply of vaccines. And there were no vaccines left for Africa, which had been relying on COVAX for supplies.

It was a bitter replay of the HIV pandemic when antiretroviral drugs were not affordable or available on this continent. 

Key African leaders resolved that there was only one feasible way forward to break this dependence: to build continental vaccine production capacity.

John Nkengasong, director of the Africa Centre for Disease Control, then-Africa Union chairperson and South African President Cyril Ramaphosa, and Strive Masiyiwa, appointed as the African Union Special Envoy on COVID-19, have led the quest to change the balance of manufacturing power and prowess.

Under pressure to address this inequity, wealthy nations, the global health sector, and the pharmaceutical industry have responded with an array of African-based endeavours.

The most committed initiative to addressing structural inequity is the mRNA vaccine production hub in South Africa initiated by the World Health Organization, which produced a copy of the Moderna-based COVID-19 mRNA vaccine in a few months flat, and is now preparing the product for trials.

Another promising initiative includes generic producer Aspen, which was recently licensed to package, distribute and sell the Johnson & Johnson COVID-19 vaccine under its own name in Africa. 

There also are fill-and-finish operations in South Africa, Egypt, Senegal, Morocco, and Algeria for a range of vaccines from Pfizer’s mRNA COVID vaccine to the Russian Sputnik.

About 40 of Africa’s 54 countries depend on partially or wholly subsidised childhood vaccines from Gavi through UNICEF. 

The donor as ‘competitor’

But the elephant in the room is how these newer – and initially more expensive – innovations will be able to ‘compete’ with donated or subsidised vaccines from Gavi-UNICEF and more recently the COVAX platform, in the case of  COVID-19 vaccines, without derailing entire countries’ immunisation programmes

UNICEF’s Supply Division based in Copenhagen is the world’s biggest buyer and supplier of vaccines for developing countries and it procures the majority of Gavi-funded vaccines.

Patrick Tippoo, Biovac

Back in February, Patrick Tippoo took this elephant by the trunk in a webinar organised by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

Tippoo has over 30 years’ experience in the vaccine manufacturing arena, and is a founding member of the African Vaccine Manufacturing Initiative (AVMI).  He also is an executive at Biovac, the South African company playing a key role in the mRNA vaccine hub alongside Afrigen.

“Critically important is the whole issue of sustainability of that which is being built and is being invested in going forward,” said Tippoo. “Without a significant change in the market dynamics on the African continent there’s very little likelihood of successful sustainability of all our efforts behind this initiative.”

Tippoo explained that about 40 of Africa’s 54 countries are “wholly or partly dependent on partially or wholly subsidised vaccines from Gavi through UNICEF. Much of the vaccine supply into Africa comes in a subsidised form, partially or completely by GAVI through UNICEF.” 

And that market is not just COVID-19 vaccines but billions of dollars of vaccines for childhood diseases ranging from measles and mumps to polio.

Traditionally, Gavi and UNICEF have focused on buying the cheapest medicines rather than addressing supply chain diversity or equity, insiders have told Health Policy Watch.

More recently, however, Gavi has given the Developing Countries Vaccine Manufacturing Network (DCVMN), an alliance of 44 companies from 16 developing countries, a seat on its board. It also says that “by 2017, nearly two-thirds of our vaccine suppliers were based in Africa, Asia or Latin America”, although this statement obscures the fact that precious few African companies are part of the mix.

The procurement patterns of the big donor-driven agencies have also tended to foster market dominance by a few, larger firms – whether based in India, China or western nations – at the expense of smaller, start-up (and often African) manufacturers whose products also are inevitably going to be more expensive, at least in the early years.    

“We know that Gavi drives prices down to make vaccines more affordable so more vaccines can be purchased and therefore distributed,” Tippoo added. 

“So some say that the vaccine market in Africa is actually in Copenhagen [the headquarters of UNICEF’s Global supply and Logistics Hub]. This is a structural thing that will have to be addressed because, in order to stimulate and incentivize technology transfers, investment in skills, development, regulatory capacity building and all these things that we repeat ad nauseum, there needs to be an assurance that there’s going to be a market [for African vaccines] when all of this is built.”

Gloomy forecast for African vaccine manufacturing 

Hardly two months later, Tippoo’s gloomy forecast of the market dynamics has already proven accurate: Aspen has not received a single order for its J&J COVID-19 vaccine from African countries that are getting free or heavily subsidised vaccines either directly from rich countries or indirectly through COVAX-backed procurement orders.

This was disclosed two weeks ago by Africa CDC’s John Nkengasong recently, who appealed to Gavi and COVAX to “rally around” Aspen to protect vaccine production on the continent.

It was “shortsighted” of African countries to rely on vaccine donations at the expense of the continent’s vaccine manufacturing capacity, Nkengasong told an Africa CDC media briefing:

“There is a global consensus that, in order to ensure global health security, there must be regional vaccine manufacturing capacity,” he said.

“Here we are with a company that is producing an amazing vaccine that the continent is using, that is running a risk of shutting down that production. We cannot and must not allow that to happen.

“If we only rely on donor vaccines and do not invest in and promote our own facilities on the continent that is a recipe for going backwards the next time we are hit with another pandemic.”

South African President Cyril Ramaphosa visits Aspen Pharmacare manufacturing facility in Gqeberha.

Gavi ‘in discussion’ about Aspen

A GAVI spokesperson told Health Policy Watch on Monday that “COVAX is committed to diversifying global supply, including through the development of regional manufacturing sites, especially in Africa. 

“In the case of Aspen, the current overall demand situation means we are currently not in a position to buy large quantities of vaccines. However, we are in discussion to see if a collaboration would be feasible as part of expanding regional supply.” 

Nkengasong confirmed that there were discussions with Gavi, which manages COVAX, about supporting Aspen’s COVID-19 vaccine production line, which the company has warned it will have to close soon if it doesn’t get orders.

But the immediate outlook is not rosy now that there is a glut of COVID-19 vaccines.  And competition between the big global pharmaceutical players for the African vaccine market is becoming more intense as the continent is the last major source of unvaccinated people on the planet. 

More equity also equals more global health security 

In all the many discussions about a pandemic instrument to address future pandemics, all WHO member states have committed themselves to the principle of equity. But the diversification of vaccine procurement is not just about equity. It will also ensure more robust and flexible supply chains during a pandemic, which will strengthen global health security. 

“We need diversification in terms of geographic locations, where these capacities might be located across the continent, diversification in terms of product mix, what different entities are going to focus on in terms of vaccine development and vaccine manufacturing pipeline, but also diversification in terms of technologies,” Tippoo said. 

“This is not only about Africa for Africa. This is about Africa gearing up to take a significant position and place around the global table. Africa can contribute to a diversified global supply chain when it comes to vaccines.”

Image Credits: UNICEF South Africa/2013/Hearfield.

Pfizer’s Paxlovid has shown 85% efficacy in preventing severe disease in who take it in the first few days of COVID-19 infection.

The World Health Organization (WHO) has recommended Paxlovid, the antiviral medicine produced by Pfizer, for patients with COVID-19 at high risk of developing severe disease – but it is concerned about limited access to the life-saving medicine.

Friday’s WHO recommendation is aimed at “patients with non-severe COVID-19 who are at highest risk of developing severe disease and hospitalization, such as unvaccinated, older, or immunosuppressed patients”. 

It comes after a recent clinical trial of over 3000 patients found that Paxlovid reduced the need for COVID-related hospitalisation by 85% in high-risk patients who were given the medication early on in their infection.

Lack of availability

WHO Access to Medicines Technical Officer Jane Hedman

But the WHO added that “availability, lack of price transparency in bilateral deals made by the producer, and the need for prompt and accurate testing before administering it, are turning this life-saving medicine into a major challenge for low- and middle-income countries”.

Lisa Hedman, WHO technical officer for access to medicines, noted that the Paxlovid deals reported in the public domain “show a total that appears to be within Pfizer’s production capacity, which they’ve estimated to be approximately 80 to 100 billion treatments per year”. 

However, Hedman told a media briefing on Thurday, “not all deals are reported in the public domain”, and the WHO was aware of “several large procurers, including to multilateral deals and a couple of countries” that “could actually strain supply in the short term”.

Pharma flags regulatory and health system barriers

Pharmaceutical manufacturers including Pfizer also flagged the problem of access to Paxlovid at a media briefing last week – but cited the main barriers as lack of swift regulatory approval, allocation strategies, health systems capacity, and a lack of COVID-19 testing (the antiviral is only effective if it’s given to people early on in their infection), 

Last month Pfizer announced it would supply UNICEF with up to four million treatment courses for 95 low- and middle-income countries, pending authorization or approval.

“Supplying to UNICEF is an important part of our comprehensive strategy to accelerate access to Paxlovid to treat COVID-19 infection as quickly as possible and at an affordable price in order to decrease the strain on healthcare systems and help save lives in low- and middle-income countries,” said Pfizer CEO Albert Bourla.

Last November, Pfizer signed a voluntary licensing agreement with the Medicines Patent Pool (MPP) enabling it to granting sub-licenses to qualified generic medicine manufacturers to produce and supply 95 countries with Paxlovid.

This covers “approximately 53% of the world’s population”, including “all low- and lower-middle-income countries and some upper-middle-income countries in sub-Saharan Africa as well as countries that have transitioned from lower-middle to upper-middle-income status in the past five years”, according to a media release.

Pfizer CEO Dr Albert Bourla

Last week, Bourla told a media briefing hosted by International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) that almost 250 companies had indicated their interest in producing Paxlovid to the MCC, which in turn had suggested around 35 companies.

“I don’t think that they will be able to manufacture pretty soon though, although it is very, very easy to do it, and they will do it in already existing facilities,” said Bourla.

“But right now, my concern is what do we do in the meantime for these countries. And this is why we signed an agreement with UNICEF to provide them at-cost, millions of doses that can go to countries, [and] after that the generic companies can take over and provide those doses.”

Call for transparency

The WHO noted on Friday that, since the MCC agreement had been signed, “several generic companies are in discussion with WHO Prequalification but that it may take some time to comply with international standards before they can supply the medicine internationally”.

“WHO therefore strongly recommends that Pfizer make its pricing and deals more transparent and that it enlarge the geographical scope of its licence with the Medicines Patent Pool so that more generic manufacturers may start to produce the medicine and make it available faster at affordable prices,” the organisation added.

“Ninety-five countries is a good number, but WHO would really like to see that number expanded to include more countries to recognise the need for equitable access across really the broadest group of countries possible,” said WHO’s Hedman.

Lack of testing

A significant access barrier to Paxlovid is the global drop in COVID-19 testing amid the perception that the pandemic is over. In addition, only 21.5% of tests administered worldwide have been used in low- and lower-middle-income countries, despite these countries comprising 50.8% of the global population, according to the global test tracker, FIND.

These countries also tend to have lower vaccination rates, which means their populations are more vulnerable to severe disease. Yet only people caught with early infection can benefit from Paxlovid.

On Thursday, the Africa Centre for Disease Control reported a 23% drop in tests over the past week despite five African countries experiencing a fifth COVID-19 wave.

Danger of drug-on-drug interactions

WHO’s Janet Diaz

WHO official Dr Janet Diaz, explained at a media briefing on Thursday that “Paxlovid is made up of two medicines, nirmatrelvir and ritonavir. The nirmatrelvir inhibits the SARS-CoV2 protease and thus stops viral replication”

Diaz, who is the WHO’s COVID Clinical Care lead, added that nirmatrelvir is “co-administered with ritonavir,  an HIV protease inhibitor that boosts the effect of the nirmatrelvir but it itself does not exert any antiviral effect against SARS-CoV2 so this is considered a monotherapy antiviral.”

However, Diaz warned that Paxlovid was not to be given to pregnant or breastfeeding women or children, as it had not been tested on these groups.

“This drug does also have many possible drug-to-drug interactions. And this is because of the effect of ritonavir on an enzyme that’s important in the metabolism of other drugs,” warned Diaz. 

“So it is important if you are a patient that you tell your doctor what other medications you may be taking so they can do a quick check to see if there are any serious possibilities of a serious drug-to-drug interaction.”

Image Credits: Pfizer .

An infant is vaccinated at a primary health care clinic in India.

Discussions about the creation of a new global convention on pandemic preparedness and response have already become a bit like a Christmas tree. 

Last week’s WHO-convened public hearings, saw a wide array of interest groups trying to attach a number of features to the proposed international pandemic instrument, ranging from stronger accountability and transparency measures in reporting outbreaks to ensuring equitable access to vaccines and treatments – and rapid and transparent pathogen-sharing so that new treatments can be quickly created.   

These issues will be further explored in a high-level discussion at the upcoming Geneva Health Forum (GHF) (3-5 May), on the pandemic treaty on the morning of Day 2.

Professor Stéphanie Dagron, Faculty of Law and Medicine at the University of Geneva

However, one important issue that has not yet figured prominently in the discussions is how the new legal instrument could also be used as a tool to concretely advance national social health protection systems that are fundamental to reaching the objective of Universal Health Coverage (UHC), notes Stéphanie Dagron, a professor in international health and social security law at the University of Geneva.

Linking UHC with a pandemic instrument 

Having robust social health protection systems, whether they are entirely tax-financed or based on contributions (through social insurance), or more likely a hybrid of both financing models, is key to getting more people to turn to health care providers when they become ill, she points out to Health Policy Watch ahead of the start of the GHF.

And that, in turn, is critical to identifying emerging disease threats very early on, as well as to rolling out treatments.

 “I’m really convinced that if we want to prevent a novel outbreak, it is absolutely necessary that the population has regular contact with a health system,” says Dagron.  “And without Universal Health Coverage, if people do not have basic access to health care services, they will wait and wait before turning to medical help if an outbreak occurs – and at some point, it will explode. 

In addition, COVID-19 has shown how people with pre-existing conditions, including obesity and diabetes, are particularly vulnerable to severe illness. So getting non-communicable diseases (NCDs) under control – through the extension of UHC –  is equally critical to pandemic preparedness and response, she points out. 

“In a pandemic, we are not only dealing with communicable diseases. NCDs are a big factor, as well as being the cause of most deaths overall, and that burden is getting bigger and bigger,” says Dagron.

Countries with 50% or less of the population covered by essential UHC services: most are in WHO’s African or Eastern Mediterranean regions. The WHO UHC Service Coverage Index tracks progress on the SDG indicator 3.8.1

Lack of UHC legal and financing frameworks 

But many challenges need to be overcome to make UHC a reality, including legal preparedness. The elements of the system authorizing access to health care services for all should be defined in the national legislation (the benefit package and the collective mechanisms used to cover the cost of care).

Despite constant lip service paid to UHC, current SDG indicators for achieving UHC by 2030 lack any clear reference to the kinds of legal and financing frameworks that countries, and the global community, really need to develop to achieve the goal, she points out. 

Rather, the two existing indicators to track progress on UHC (SDG Target 8.3) look purely at “endpoints” such as UHC essential health service coverage. And even such basic coverage is woefully low – 50% or less in about 65 countries,  mostly in Africa, the Middle East and Asia, according to the latest WHO reporting on the UHC indicator SDG 3.8.1. 

“There are only two indicators, and they are primarily medical or economic indicators [of healthcare spending] at household level,” Dagron says. “They say nothing about the kind of health coverage schemes that need to be put in place to achieve UHC.” 

Endpoints are important to track, of course. But likewise, tracking also needs to follow progress on what countries are doing to actually create universal health coverage systems – for which a legal framework for the different healthcare schemes, and transparency and sustainability of the main sources of funding for healthcare coverage, are critical.    

“Many countries need help to create the necessary legal and financing structures for social health protection systems – this is one expertise that is missing at WHO, the legal expertise to support countries in creating a basic legislative architecture for UHC,” she points out.  

Pandemic treaty offers an opportunity to advance UHC 

Dagron sees, therefore, an opportunity for the pandemic treaty talks to empower WHO, together with the International Labour Organization (ILO), to help advance UHC by building country capacity to create, fund and implement their own national social health protection systems. 

That could be a win-win for the negotiations, she says, paving the way for some early achievements in the treaty negotiations between WHO member states – which may be more enthusiastic about setting goals for UHC, than for other, highly controversial issues that the treaty’s proponents will eventually need to tackle.  

Currently, international legal frameworks referencing the creation of social health protection systems exist only in piecemeal forms, with norms to be found in human rights and social security standards, she said. 

However, one significant precedent is the  2012 ILO Recommendation (202) on “Social Protection Floors. This Recommendation, approved by the ILO’s General Conference of member states, sets out a framework for countries to establish social security systems – in which access to essential healthcare services based on diverse arrangements for the financing is framed as an essential component. 

A ‘Global Fund’ for UHC?  

Economic initiatives to support countries in extending social health protection systems that foster universal health coverage are similarly lacking, she notes.  By all available indicators, national government spending on health is woefully behind global and regional targets. 

But UHC and NCD advocates have often pointed out that even governments in low-income countries could potentially raise more tax revenues from unhealthy products such as sugary drinks, tobacco, dirty vehicles or fossil fuels – and channel those into health systems – for a win-win approach.   

In the 2001 Abuja Declaration, most African governments committed to increasing public health spending to at least 15% of the government’s budget. 

However, between 2002 and 2014, the share of government spending allocated to health actually decreased in about half of African countries. Only four countries were above the Abuja target in 2014, notes a 2021 World Bank report that reviews the dismal progress on advancing UHC in the African context. As of 2016, only two of 55 AU member states met the target – Madagascar and Eswatini although South Africa, Namibia and Zimbabwe were close to the goal – and some 35 AU states overall had increased spending in the past year. However since then, the AU’s UHC scorecard hasn’t even been updated. 

Only four African countries had met or exceeded the Abuja target of spending 15% or more of the national budget on health as of 2014 (World Bank, 2016).  And that declined to just 2 countries by 2016.

To assist with the rollout of UHC, the global community could create another, new “Global Fund” for UHC modeled along the lines of the successful Global Fund to Fight AIDS Tuberculosis and Malaria – which currently spends about $4 billion a year supporting low- and middle-income countries’ spending on related health programmes – but also creates criteria for such support and a pathway for countries to become financially self-sufficient. 

Solidarity as a principle

Among the big-picture principles that a pandemic instrument should address, Dagron would like to insist on solidarity. 

“There are so many things that people want to pack into a pandemic treaty,” she observes. “You need to define the central principles that are going to be applicable, and for a lawyer, having principles defined at first, is extremely useful because you use the principles to interpret the rest of the convention. 

“Countries with social health protection systems all rely upon the principle of solidarity in their legal frameworks,” says Dagron. “This has implications for the way you define the objectives of your system, finance the services and essential goods needed and the way you organise access to these services and distribute needed goods.  

“The principle of solidarity should guide and structure the activities of the global community.

Barriers to UHC

In order for countries to expand social health protection to achieve UHC, they will have to enshrine the different health care schemes into their national legal framework. To facilitate this, the global community should define a system that offers more support (technical and financial) to member states and an adequate monitoring system.

A monitoring system for the implementation of UHC in the pandemic treaty should assess the actual implementation.

Effective health coverage is different in most countries and certain groups are often excluded from national health schemes or certain benefits. 

At the same time, the fact that exceptions may occur is not a good argument for avoiding the implementation of UHC altogether, she points out. 

“Admittedly, these are complex issues.  You have to define what is an essential health service in a country, and this is something that cannot be decided at the international level. 

“But that is why the ILO recommendation of 2012, to which WHO contributed,  was interesting because it said that states have to do four things, including making sure there is access to a nationally defined set of goods and services, constituting essential health care; adapted to the needs of the population and creating systems of income security for security for children, for older persons and people active in the workplace.”  

 

See the complete GHF 2022 programme. Register here: Until 2 May fees are CHF 400 for the entire event and CHF 150 for participants from low- and middle-income countries (OECD classification).  Daily rates are also available. 

Check out Health Policy Watch’s ongoing coverage of other themes featured at this year’s Forum on our GHF 2022 microsite

Image Credits: WHO/Christopher Black, S. Dagron , WHO Global Health Observatory , UHC in Action: A Framework for Africa .

Africa CDC director John Nkengasong

Only 10 of Africa’s 54 countries have vaccinated more than a third of their citizens, although the continent has administered over two-thirds of the vaccine doses it has procured.

The top 10 vaccinators are Seychelles (81%), Mauritius (76%), Rwanda (64%), Morocco (63%),  Cape Verde (55%), Botswana (54%), Tunisia (53%), Mozambique (43%), São Tomé and Príncipe (40%) and Lesotho 36%. Five of these are countries with very small populations.

In total, only 16.3% of Africa’s population has now been fully vaccinated, according to Africa Centres for Disease Control director Dr John Nkengasong.

However, he told a Thursday media briefing that, of 770 million vaccine doses procured, 517 million had been administered, representing 67% of the total available stock.

Vaccine consumption in the 14 most populous AU member states ranged from 21% in Madagascar to 94% in South Africa and 93% in Ethiopia. Egypt and Morocco have used up 90% of their vaccines but Nigeria and Ghana had only administered about half their doses. 

Fifth wave

While nine African countries are experiencing a fifth COVID-19 wave, Africa reported a 21% decrease in new cases  – although at the same time, it also performed 23% fewer tests.

Nkengasong urged all countries to continue testing, adding that the test positivity rate was “a high 11%”.

Algeria, Benin, Congo Republic, Egypt, Guinea-Bissau, Kenya, Mauritius, Somalia and Tunisia are in the midst of their fifth wave.

The five countries reporting the highest increases in cases are (in order of increases): South Africa, Egypt, Tunisia, Seychelles and Zambia.

On Wednesday, South Africa reported its highest cases in three months – 2,846 new cases with a 13,4% positivity rate, according to the National Institute for Communicable Diseases (NICD).