Tuberculosis
Baraka, one of ADOPO’s landmine detection rats born in Tanzania, is described as playful and curious. He has two sisters and a brother following in his footsteps.

For months, Sharifa Shomale suffered in silence from tuberculosis, not knowing what was wrong with her. Doctors suspected a viral infection. Then an unlikely hero made a life-saving discovery: a mischievous rat named Hamisi.

DAR ES SALAAM, Tanzania—Every evening, as the call to prayer from the mosque echoes in the twilight from Manzese—a tangled Dar es Salaam slum dotted with flimsily built homes, Shomale routinely swallows a dozen pills. That’s not easy for the 38-year-old mother of three children, but it’s much better than the disease itself.

“I had all TB symptoms such as a bad cough, chest pain, and I was spitting bloody mucus,” she told Health Policy Watch, describing what she later learned were common TB symptoms along with fever, loss of appetite, and weight loss.

When Shomale became pregnant with her fourth child, her symptoms worsened. Yet doctors at Palestina hospital in Dar es Salaam, where she was receiving treatment, suspected she had contracted a viral infection.

Distraught, the visibly sick Shomale started to lose weight. At some point, she feared her unborn baby wouldn’t survive given her ill health.

“The doctor asked me to take an X-ray, but the photo did not provide any clear diagnosis, “she said.

Luckily, a friend advised her to visit the “HeroRats” TB detection facility in Dar es Salaam to have her phlegm checked. To Shomale’s surprise, an African giant pouched rat with a highly developed sense of smell detected mycobacterium within hours of investigation.

“I was very relieved, knowing that doctors would prescribe proper medication and I would stick to the treatment plan,” she said.

Shomale is not alone. Tanzania is among the world’s 30 countries with the highest burden of TB. And yet here, like in other high-burden countries, many people remain undiagnosed due to a historic lack of access to diagnostics that will simply tell them that they have the disease.

A holy grail

Quick and accurate diagnosis of TB has long been an elusive holy grail for clinicians, who describe it as a major barrier to extending treatment to the estimated 10.6 million people infected with the disease in 2021, of which only 6.4 million (60%) were actually diagnosed.

The dearth of diagnostics means that one of the world’s oldest known diseases still ranks as its deadliest too, claiming some 1.6 million lives in 2021, including 187,000 HIV positive people, according to the World Health Organisation’s 2022 Global TB report.

Diagnosis of TB via the age-old technique of sputum smear microscopy, which analyzes a sputum sample under a microscope, is still only accurate about 65% of the time, despite improvements to low-cost LED smear microscopy.

More sophisticated molecular-level diagnosis with tools like GeneXpert have been expanded under initiatives by STOP TB and the Global Fund, but still remain costly and thus out of reach to people in many low- and middle-income communities worldwide.  

Rats have a hypersensitive capacity for detecting odors 

Cars pass through Sharifa Shomale’s Manzese neighbourhood in Dar es Salaam.

In the quest to stop the spread of tuberculosis, scientists in Tanzania are taking advantage of rats’ highly developed sense of smell to detect TB bacteria more rapidly and accurately.

While rats are ill-famed for stealing food in the kitchen, nibbling expensive clothes in the wardrobe, and even spreading diseases, in Tanzania they are now gaining new stature for saving lives.

The giant African poached rats, famous for their  role in detecting landmines due to their light weight, ability to sniff out chemical compounds of explosives and ignore scrap metal, are being trained by APOPO, a Belgian non-profit organisation, to detect TB bacteria and save lives.

At ‘HeroRats’ TB detection centre in Dar es Salaam, where Shomale was successfully diagnosed, a mischievous rat nicknamed Hamisi darted between six split phlegm samples placed in a glass-sided cage.

The rodent momentarily used its nose to hover above a potential TB infection, then scratched the cage’s bottom while rubbing its front paws to confirm a positive diagnosis.

Then a researcher in a white lab coat used a giant syringe to inject a mix of crushed avocado and peanut in a small hole — a treat for the rat’s job well done.

Within minutes of scuttling over the phlegm samples, the playful rat adeptly identified five potential TB cases, APOPO’s researchers said.

Since his birth in 2018, researchers say Hamisi the rat helped save the lives of many patients including Shomale. On a typical work day, Hamisi can examine up to 100 samples before going for a rest in an open-air play cage.

“Rats are very fast, they can examine many samples within a short period of time,” said Joseph Soka, APOPO’s program manager.

Rigorous training

‘HeroRats’ begin training in their infancy.

At the age of four weeks, when he was still learning to open his eyes, Hamisi was exposed to various stimuli, and was conditioned to socialise with humans before he underwent special training to identify TB bacteria, Soka said.

The trained rats were able to screen tuberculosis samples with an accuracy of up to 85%, according to Soka. In contrast, smear microscopy, which also uses mucus from the patient’s lower respiratory tract, has a lower rate of sensitivity, ranging from 20% to 60%, he said.

In combination, the rats can help improve the pace and accuracy of sputum smear diagnosis, he said, noting that “we use the rats to re-evaluate human sputum samples from our partner clinics. One rat can screen a hundred samples in just 20 minutes.”

While a lab technologist can take a few hours peeping through a microscope to detect tuberculosis strains on a cultured phlegm sample, a trained rat can screen dozens of sample in minutes at a cost of as little as two cents ($.02) a sample screen, Soka said.

Despite their skill in detecting tuberculosis, the rats have their limitations since they cannot distinguish between different types of TB strains or identify the particularly dangerous strains that respond to only a few medications, known as multi-drug resistant (MDR) or extremely drug resistant (XDR), APOPO scientists say.

More than 579,770 sputum samples from 337,737 suspected TB cases have been screened since the project started in 2011, APOPO officials told Health Policy Watch.

For Shomale, who finally gave birth to a healthy baby boy, the TB diagnosis motivated her to immediately start treatment and reduce chances to pass on the pathogen to the rest of her family members.

“When I started taking the pills, I was no longer worried about infecting others,” she said.

A heavy burden

Tanzania is among the 30 countries with the highest burden of tuberculosis in the world. According to WHO, 142,000 Tanzanians (253 per 100,000) fell ill with TB in 2018, including 40,000 (28%) that also were reportedly living with HIV/AIDS. 

Among those, however, just 75,828 people received a lab-confirmed diagnosis. This means that some 47% of those people living with TB remained untreated, at risk of dying or transmitting the disease to friends, family and neighbors.

Health authorities in Tanzania have for decades relied heavily on smear microscopy — an outdated diagnostic technique which involves collecting and examining human sputum samples under a microscope.

Critics say positive TB cases are repeatedly going undiagnosed due to the shortage of services in rural areas and the equipment’s high margin of error.

And given the deeply rooted cultural stereotypes and low awareness of chronic diseases afflicting people in rural areas, many TB patients are stigmatized even by members of their own families – who may perceive the patients as “bewitched” rather than ill, bringing a curse upon their local community. 

On the edge of death

Mathew Kaloli writhed in pain and agony. Too frail to get on his feet, the 66-year-old fisherman from the country’s northeastern Bagamoye district suffered from chronic drug-resistant tuberculosis.

Because his diagnosis was delayed, his chances of survival were slim. “My father has lost hope of living,” his son Karim told Health Policy Watch.

An old X-ray photo showed the disease’s devastation to Kaloli’s right lung. Nestling on the chest like a delicate balloon, the lung – which should normally appear white in the photo – looked dark. The X-ray showed the landscape of the chest cavity, scrambled beyond repair.

Unlike Shomale, whose TB diagnosis was positively confirmed quickly after she sought help, Kaloli suffered in silence for many months, to the point where the disease could outwit most antibiotics. 

In an interview with Health Policy Watch, Riziki Kisonga — a pulmonologist at Tanzania’s National Tuberculosis and Leprosy programme, said the fight against tuberculosis requires rapid, innovative, and affordable detecting techniques.

“As an infectious disease that primarily affects the lungs, TB can prove fatal in the absence of timely and comprehensive treatment,” he said.

Patients need to seek treatment

Microscopic view of mycobacterium tuberculosis in the lungs.

Powerful and effective drugs are freely available in public and private health facilities across Tanzania, but TB patients often fail to show up at health facilities to receive them.

While rapid diagnosis is one barrier, it is not the only one. It is common, for instance, for some TB patients to stop taking the drugs when they start to feel better, Kisonga said, even though they may not yet be fully cured.

“If a patient takes the right medication for the right duration as advised by doctors, chances are high he/she can get cured,” he said.

Kisonga urged TB patients to get comprehensive treatment – to the end of a  course, along with using proper cough etiquette to avoid infecting others.

“Early diagnosis and effective complete treatment is the key for cure,” Kisonga said.

For Shomale, the novelty of a life-saving discovery being made by a rat has made a lasting impression..

“I always trap and kill rats at home. I never thought they would someday help doctors find a disease in my own body.”

Image Credits: ADOPO, Rwebogora, Laëtitia Dudous, Roche .

First COVID vaccinations of Israeli health workers in 2019.

In the wake of the COVID pandemic, the US National Institutes of Health (NIH) and Israel’s largest medical center, Sheba Medical Center, are launching a scientific collaboration aimed at identifying emerging disease threats in the region.

One of the first projects planned will be a study examining the impacts on antibody defenses amongst travelers from Israel or Palestine to Mecca to observe the annual Islamic Hajj pilgrimage, one of the world’s largest mass religious gatherings, a representative of the NIH told Health Policy Watch.

The Sheba Pandemic Research Institute (SPRI), a first-of-its kind partnership between Israel and the NIH, was launched late last month at a ceremony in Israel attended by Prof Daniel Douek, Chief of the Human Immunology Section at NIH, who now also serves as the senior scientific advisor of the newly-formed SPRI.

The project is being largely funded by Sheba, the country’s largest private hospital, with support from Israel’s Health Ministry. Douek and the Sheba project organizers, however, stressed that they intend to collaborate with Palestinian hospitals and physicians in research on disease threats that cross political and geographic borders.

SPRI will focus on basic science and clinical research on emerging pathogens and the host response. Through multidisciplinary, multifaceted and collaborative research, the institute hopes to translate basic science research into infectious diseases into clinical products. These biological countermeasures would be rapidly deployable in the event of epidemic and pandemic threats.

In Israel, the centre will be run by Prof Gili Regev-Yochay, head of the Infectious Diseases Unit at Sheba Medical Center, and a scientist who was on the forefront of Israel’s 2020-21 COVID pandemic response and vaccine roll-out, which served as a weathervane for other nations.

Preparedness for next pandemic

Global health leaders have stressed that early warning and preparedness are key to head off the health impacts and disruptions to economies and travel that COVID created. Portayed here, South African soldiers patrol Johannesburg during a COVID lockdown in early 2021.

Regev-Yochay said that SPRI is being established despite the decline in COVID-19 incidence in most parts of the world, in order to be better prepared for the next pandemic, whenever and whatever that may be. The goal is to be able to have gained enough know-how to take quicker and more effective action next time a deadly pathogen begins circling in the community.

During a speech at the launch ceremony for the new cooperation, Regev-Yochay recalled the first two months of the pandemic, which she said “seemed like two years” and during which she slept no more than two hours a night.

Her scarce rest was “filled with dreadful nightmares,” she said. “I dreamed there was a tsunami and I wanted to stop it. I ran towards it but I understand my body is too small to stop the water from coming in. I felt the first drops and then woke up sweating.

“There was a heavy load of responsibility on my shoulders.”

During the first wave of COVID-19, she said one of her colleagues at the hospital was infected and nearly died of the disease.

Regev-Yochay was also amongst the first people in Israel to take the Pfizer COVID-19 vaccine in Israel’s vaccination campaign, which launched on December 19, 2020 – just days after vaccinations began in the United States.

“I was truly excited,” she recalled. “Vaccines are the only fast way out of pandemic.”

But from those initial shots, many questions arose: How effective will the vaccine be in real life vs. clinical trials? How many times a year will people need to vaccinate?

These questions led Regev-Yochay to recruit hundreds of Sheba healthcare workers to participate in several COVID-19 longitudinal cohort studies over the past two years.

“When I told Prof [Yitshak] Kreiss – [director-general of Sheba] – about the idea of the healthcare workers he said, “recruit everyone you can. We need to report to the world. We have that responsibility.”

Throughout the pandemic, those studies provided valuable insights into disease trends and vaccine responses that were taken up by countries around the world.

Testing antibody responses during mass gatherings

The Kaaba at al-Haram Mosque in Mecca during the start of the annual Hajj pilgrimage, pre-pandemic. In 2020 and 2021, the number of pilgrims was sharply restricted by Saudi Arabia, but numbers rebounded in 2022.

While the collaboration kicks off at a particularly fraught time politically in Israel and the region, Kreiss and other researchers at the launch stressed the importance of fostering scientific cooperation on diseases that transverse geographic and political borders.

Daniel Douek
Daniel Douek

The first SPRI study will focus on Muslims from Israel and Palestine who make the pilgrimage to Mecca, Douek explained. The aim would be to create a profile of antibody responses from the worldwide gathering that brought together 2.5 million people in 2019, before the COVID pandemic, and 1 million in 2022, as travel began to rebound from pandemic lock downs.

WHO has frequently stressed the significance of mass gatherings from football matches to religious gatherings as potential hotspots for disease transmission, which can lead to the emergence of new diseases or re-emergence of latent threats.  Good surveillance is key to understanding those patterns.

“We thought it would be very interesting to … just measure what antibodies they have against different viruses before and after the Hajj. This will give us some insight into transmission of viruses from all of the other populations they encounter and what they bring back.”

Over time, depending on funding, the teams hope to examine pilgrim cohorts from other countries, and people in the host country, Saudi Arabia, who are exposed to so many visitors.

The NIH and Israeli teams will be working with Palestinians scientists affiliated with institutions in the Palestinian territories, Douek stressed.

“Scientists, like viruses, don’t know international boundaries,” Douek said. “We work across them very well.”

He said the hope is to launch that project by early 2024, when that year’s Hajj takes place between 14-19 June.

Data sharing

Douek said SPRI arose out of basic desire to “do what we enjoy – work together, learn from each other and make a difference.”

He is the founder of the NIH’s PREMISE (Pandemic Response Repository through Microbial and Immunological Surveillance and Epidemiology) program, which has been setting up a global network of partners, hospitals and labs across the world. The original intent was for Sheba to become of those international partners. But Douek said that “as communication proceeded, it became clear to Gili and her team that they could set up a much bigger pandemic preparedness unit of their own at Sheba.”

The collaboration between SPRI and PREMISE includes the sharing of data, human samples and other materials, as well as formal Zoom meetings ever two weeks. Sheba doctors are also expected to go to the NIH for training and NIH staff will also like go to Sheba to help them set up their labs and learn from them.

“I see this relationship evolving even further – I think it has to,” Douek said. “Pandemic preparedness can be seen as security issue, particularly for a small country like Israel.”

Douek said some research is also expected to be conducted around Israelis who work with birds in the Hula Valley, where this year a lot of cranes died of a highly pathogenic bird flu. There is also some interest in studying West Nile fever.

Translating their work to benefit LMICs

He said a final goal of both PREMISE and SPRI is to see how their work is translatable for use in low- and middle-income countries.

“The intent is to make [the work] available to everyone, especially the countries that need it most,” he said.

Douek added that there are pandemic preparedness initiatives being set up all over the world at the moment.

“A lot are being talked about, some are being set up,” he clarified. “There needs to be recognition globally that the world needs to do this. Every country in the world needs something like SPRI.”

Image Credits: Sheba Medical Center, Clalit Health Fund , Flickr: IMF Photo/James Oatway, Al Jazeera English, National Institute of Health.

Omicron
A COVID-19 sanitation worker at a ferry in the Chinese port city of Dalian. Relaxation of strict COVID measures and low vaccine rates have led to a surge in cases.

As nations clamp down on travellers from China during an Omicron surge there Chinese health experts have told the World Health Organization that two known Omicron lineages are dominating the current Chinese surge, with BA.5.2 and BF.7 together accounting for 97.5% of all locally-acquired infections. 

The data was contained in a report by WHO’s Technical Advisory Group on Virus Evolution (TAG-VE) released Wednesday, following a meeting with China CDC officials to discuss the COVID surge being experienced in the country.

The TAG-VE meets regularly to review the latest scientific evidence on circulating SARS-CoV-2 variants, and advises WHO on needed changes in public health strategies.

During the meeting, China CDC scientists presented WHO with new genomic data – which they said demonstrates that BA.5.2 and BF.7 together accounting for 97.5% of all locally-acquired infections.

The data on locally-acquired infections was based on more than 2,000 genomes collected and sequenced since Dec. 1, according to the WHO meeting report.

“A few other known Omicron sublineages were also detected albeit in low percentages,” said WHO in its report on the meeting with China CDC. “These variants are known and have been circulating in other countries, and at the present time no new variant has been reported by the China CDC.”

WHO appeals to China for ‘more rapid, regular, reliable’ data

WHO’s Director General Dr Tedros Adhanom Ghebreyesus calls for more transparency from China on COVID surge at first press briefing of 2023.

In a press conference shortly after the report was released, WHO Director General Dr Tedros Adhanom Ghebreyesus called on China to provide more transparent information on sequenced genomes, as well as information on COVID hospitalizations and deaths, which he and other top WHO officials suggested may have been under-reported.

“We continue to ask China for more rapid, regular reliable data on hospitalizations, as well as more comprehensive, real time viral sequencing,” said Tedros.  “WHO is concerned about the risk to lives in China,” he stressed, but added that such data is also essential for WHO to update its risk assessments related to the COVID surge being seen in China and its impacts elsewhere.

“This data is useful to WHO and the world, and we encourage all countries to share it. The data remains essential for WHO to carry out regular, rapid and robust risk assessments of the current situation and adjust our advice accordingly,” he said.

Concern new variants could emerge

COVID worker in Macau, China during summer lockdown. The lifting of restrictions in the late fall led to a surge of cases, leading to fears of new variants.

Tedros also pushed back at the Chinese criticism of travel restrictions that have been imposed by a string of nations during the current surge.

“With circulation in China so high and comprehensive data not forthcoming … it’s understandable that some countries are taking steps they believe will protect their own citizens,” he said.

Australia, Canada, India, Japan, the United Kingdom and the United States, among others, have re-imposed restrictions on travellers arriving from China, such as requiring a COVID-19 test before boarding a flight.

The Chinese government has sharply criticized the additional testing requirements, and threatened countermeasures against the countries imposing restrictions.

“We do not believe the entry restriction measures some countries have taken against China are science-based. Some of these measures are disproportionate and simply unacceptable,” Foreign Ministry spokesperson Mao Ning told a daily briefing on Tuesday.

“We firmly reject using COVID measures for political purposes and will take corresponding measures in response to varying situations based on the principle of reciprocity,” she said.

Continued evolution of Omicron virus reflects need for more data sharing

In contrast to the some 2000 gene sequences said to have been shared with WHO, China has only submitted complete data on 95 cases of locally- acquired variants to the global, open-access GISAID EpiCoV genome database since 1 December, according to the WHO expert report also published Wednesday.

That is out of a total of 564 sequences submitted since that date. Of those cases, another 187 are considered to have been imported, and 261 cases are unclassified, according to WHO’s report on the meeting.

That being said, China’s claims that the preponderance of BA.5.2 and BF.7 locally acquired infections “is in line with genomes from travellers from China submitted to the GISAID EpiCoV database by other countries,” the WHO report stated.

Both Tedros and the TAG-VE expert group emphasised the critical need for more surveillance and sharing of sequence data not only in China but worldwide, in order to understand the evolution of SARS-CoV-2 and the emergence of concerning mutations or variants.

In particular, WHO is evaluating rapidly increasing cases of the Omicron XBB.1.5 subvariant in the United States, Europe, and elsewhere, and plans to soon release an updated risk-assessment of XBB.1.5 beyond the statement issued in late October.

“Outside of China, one of the Omicron variants originally detected in October 2022 Is XBB.1.5, a combination of two Omicrong BA.2 sublineages,” said Tedros. “It’s on the increase in Europe and the US, and has now been identified in more than 25 countries. WHO is following closely and assessing the risk of the subvariant and will report accordingly.”

Use all available vaccine tools

Kate O’Brien, director of WHO’s Department of Immunization, Vaccines and Biologicals.

At Wednesday’s press briefing, WHO again urged China to make full use of all available COVID-19 vaccines to combat its current Omicron surge – including mRNA vaccines that are more effective than China’s Sinovac and Sinopharm vaccines.

Chinese-made COVID vaccines are based on traditional vaccine technology using inactivated viruses, and that technology has been demonstrated to be less effective than new mRNA vaccines against the SARS-CoV2 virus, explained WHO’s Kate O’Brien at Wednesday’s briefing.

As a result, Chinese citizens need to get three doses of locally produced vaccines to obtain the same level of protection as two mRNA doses, she said.  And current Chinese vaccination rates fall far short of that goal.

Despite the surge of COVID cases in China, and the rapid spread of new subvariants elsewhere, Tedros expressed continued optimism that 2023 could be the year when the COVID pandemic might finally be declared as over.

“COVID-19 will no doubt still be a major topic of discussion, but I believe that with the right efforts this will be the year the public health emergency officially ends.”

Image Credits: Jida Li/Unsplash, Photo by Renato Marques on Unsplash.

The first vaccine candidates against the Sudan Ebola virus arrive in Kampala, Uganda. What to do now?

The World Health Organization (WHO) isn’t talking about it publicly, but behind the scenes WHO is planning a meeting for 12 January to evaluate next steps, Health Policy Watch has learned, as the absence of new cases in the Uganda outbreak makes it impossible to begin a clinical trial based on a ring vaccination of recent Ebolavirus contacts.     

WHO’s plans to launch a clinical trial with Uganda to test three new vaccine candidates designed to combat the Sudan strain of the deadly Ebolavirus. That could come to an end, however, if the current outbreak that has claimed 55 lives since it began is declared over by 11 January, after the elapse of 42 days without new cases. 

”There have been no new Ebola cases in Uganda for three weeks. The countdown to the end of the Ebola outbreak in Uganda has begun,” said WHO Director General Dr Tedros Adhanom Ghebreyesus at a press conference on Wednesday, 21 December. “If no new cases are detected, the outbreak will be declared over on the 11th of January.” 

Already, more than 21 days has now elapsed since any contacts of existing Ebola cases were traced and identified, according to the latest Situation Report, published Monday (December 19) by the Government of Uganda and WHO’s African Regional Office.  

Contacts identified within 21 days of their exposure to Ebola comprise the test group that was supposed to receive doses of the experimental Sudan Ebolavirus vaccines, as part of the “ring vaccination” approach of the clinical trial planned jointly by WHO and the Ugandan Health Ministry.  

Original clinical plan to test three vaccines is increasingly unworkable

vaccine trials
In the original WHO protocol, three Ebola vaccine candidates were to be tried. That plan looks increasingly unworkable.

Until late last week, WHO, which led the design of the trial, was still saying that the clinical trial would go ahead, as planned, based on a protocol that would randomize contacts of Ebola cases into two groups for each of the three vaccines to be tested  – a test group that would receive the vaccine within 21 days of exposure and a “control” arm of contacts who would also receive the vaccine but only after 21 days of their exposure. 

“The trial will start by including the contacts of the recently confirmed cases of Ebola (those with date of onset less than 21 days),” a WHO spokesperson told Health Policy Watch on Friday 16 December. “For more details refer to the protocol that is already online.”  Follow-up emails requesting more elaboration received no response.  

However, insofar as “no active contacts are currently under follow-up,” according to the Uganda/WHO AFRO Situation report published on Monday, it is impossible to start a trial right now along the lines of the WHO and Uganda-approved Tokomeza Ebola ring trial protocol, a number of expert observers, as well as one of the three vaccine developers, confirmed in recent interviews.  

And if only sporadic new cases were to re-appear, testing three vaccines by immunizing recent contacts of Ebola cases along the ring model proposed for the trial would be unlikely to yield statistically relevant results, according to several clinical trial experts close to WHO. The experts agreed to be interviewed by Health Policy Watch only on condition of anonymity.  

All three vaccines now in place, but no one to receive the doses

Swati Gupti, IAVI

“The good news is it does definitely look like the outbreak is subsiding,” said Swati Gupta, head of emerging infectious disease and scientific strategy at IAVI, in an IAVI Report, 14 December. IAVI is the non-profit institute overseeing development of one Ebola vaccine candidate for the Sudan strain of the virus, and the candidate also deemed by an independent WHO advisory team to be the most promising. 

“By definition, if you are doing a ring vaccination trial, where the rings are formed by vaccinating contacts of cases; if there are no new cases, you’re not going to be able to use that particular design,” Gupta told Health Policy Watch in an interview on Friday.

That, despite the fact that 2,160 doses of IAVI’s vaccine candidate arrived in Uganda on 17 December, following the arrival of a batch of 1,200 Sabin vaccine candidates on 8 December.  On 15 December, meanwhile,  40,000 doses of the Oxford vaccine candidate, manufactured in record time by the Serum Institute of India, also arrived in Uganda. 

WHO, when asked repeatedly by Health Policy Watch for clarifications of a possible way forward on testing the three vaccine candidates against a virus that has a 40% fatality rate,  declined to comment further, saying it would be “speculation.”

Behind the scenes, however, WHO appears to be preparing for a re-evaluation. It is planning a 12 January meeting with vaccine experts and developers to discuss a way forward, Health Policy Watch has learned.

Not coincidentally, that meeting is planned for the day after the 42-day waiting period is over to determine if the current outbreak is declared over or not.  Although that meeting hasn’t yet been publicly announced, it appears to reflect a dawning realization that a new approach will likely be needed in either scenario.    

Key strategic decisions to be made  

Conversations with vaccine experts inside and outside of WHO, as well as with two  of the three manufacturers of the current vaccine candidates, underline that a new strategy will very likely be needed in order to advance potential vaccines candidates in scenarios where new cases are sporadic or nil.

Ebola
Health workers at  Uganda’s Madudu Health Center assemble in meeting with a visiting UNICEF director during the recent outbreak.

That would involve critical choices about how many vaccines can realistically  be tested – as well as whether animal models should be used to prove efficacy to speed regulatory approval of the vaccine candidates.  

“What is needed is a plan A and a plan B,” said one such expert and WHO insider, speaking on condition of anonymity to Health Policy Watch. 

“Historically the number of cases of the Sudan Ebolavirus has been very limited. We don’t know what the trajectory of this is, whether this is a small outbreak that will lead to only sporadic cases in the future, or if it is the beginning of something new.  But work being done now is absolutely paramount. 

The current trial protocol calls for testing all three vaccine candidates. These include two adenovirus vaccines, developed by the Sabin Vaccine Institute and Oxford University respectively, and IAVI’s VSV-vactored candidate. The IAVI vaccine is based on the vaccine developed by Public Health Canada and Merck & Co. against the Zaire Ebolavirus strain, successfully tested and deployed during the 2014-2015 West Africa Ebola outbreak, and, following regulatory approval, in the Democratic Republic of Congo’s 2018-2020 outbreak.

An independent advisory committee has already advised WHO that in the event that testing all three vaccines simultaneously isn’t feasible, the IAVI vaccine should be prioritized, since it is based on an adapted version of an already proven vaccine. 

Narrowing candidates down to one vaccine? 

Ebola
Contact tracers and village health teams tackling Sudan ebolavirus at its height in October – their efforts proved effective in bringing the outbreak under control.

Even in the unfortunate scenario where new cases of Sudan Ebolavirus occur, WHO and its Ugandan counterparts need to carefully weigh the feasibility of clinically testing all three vaccines against an alternative testing strategy that would test just one vaccine candidate, experts told Health Policy Watch.   

The WHO-approved trial protocol that was to be deployed in Uganda, dubbed the Solidarity/Tokomeza Ebola trial, was designed on the basis of the vaccine clinical trial staged during the 2014-2016 West African outbreak. That trial successfully tested a first-ever vaccine against the Zaire Ebolavirus strain. In that Ebola outbreak, the largest in recorded history, up to 30,000 people were infected and more than 11,000 died before it came to an end. 

But even in that much larger outbreak, just one Ebolavirus vaccine candidate, Merck’s, was initially tested on its own in a trial staged in Guinea. The trial involved more than 7,600 contacts of Ebola patients, randomized to receive the vaccine immediately or after 21 days.

A second candidate, Johnson & Johnson’s two-dose regimen of Ad26.ZEBOV and MVA-BN-Filo, was later tested as a prophylactic, and finally approved for use by the European Medicines Agency only in July 2020. 

In the case of the Sudan strain, however, outbreaks historically have been smaller and more sporadic than those involving the Zaire Ebolavirus strain that has repeatedly afflicted West and Central Africa over the past decade. 

And no one inside or outside of WHO is hoping for more Ebola cases simply to test vaccines. 

But in a context, where the likelihood is that future outbreaks may be small and more scattered, the ambitious aim of conducting trials on the efficacy of three vaccines simultaneously may no longer be fit for purpose. 

“It’s natural that in October, when cases were increasing and you didn’t know what the epidemic curve was going to look like, that the WHO would want to review all three candidates, especially given they didn’t know when they would receive doses from all three developers,” Gupta, of IAVI, said about the original approach.

“But as cases start to substantially decrease… you may not have the power to show the efficacy of all three vaccines.”

Preference for trialing the IAVI vaccine

Nurse administers the Merck-developed ebolavirus vaccine during a 2018 outbreak of the Zaire strain in DRC; IAVI’s Sudan ebolavirus vaccine is an adaptation.

The summary recommendations of an independent Ebola vaccine prioritization working group say just as much in their 16 November report. 

The working group further recommended that in the event the number of cases are too few for a trial of all three vaccine candidates, then the candidate produced by IAVI should be preferred. 

That vaccine candidate is based on the approved one-shot Merck VSV-vectored vaccine against the Zaire strain, with the genetic insert of Sudan-strain Ebola as an antigen.

“This was ranked highest on the basis of the proven safety and efficacy of the rVSV ZEBOV GP (ERVEBO™) vaccine with the Zaire strain developed by Merck, and for which IAVI now held the licensure rights for the technology,” the advisory group stated in its 16 November recommendations.

“There is extensive experience with use of rVSV ZEBOV GP in the field with approaching 400,000 doses given as part of outbreak control measures and experience with compassionate use in over one thousand pregnant women.”  

Shifting to animal models for regulatory approval?

Should future cases be nil or very sporadic, WHO and its Uganda partners may also need to pivot to animal trial models of efficacy. This, in fact, is already a strategy being considered by at least one vaccine developer, IAVI.   

Such a model was used by Bavarian Nordic to gain US Food and Drug Administration approval of its MVA-BN® vaccine in 2018 against smallpox, which was then available for a rollout this year on a compassionate use basis in response to the global outbreak of monkeypox, which WHO now recommends calling mpox. 

The FDA’s animal efficacy rule is designed for just such situations, allowing initial regulatory approval of a vaccine for rare but deadly diseases based on animal model studies that replicate human disease, combined with evidence of safety and a strong immune response from clinical trials in healthy volunteers.

“One would have to decide if it would be possible to test the vaccines clinically, or go for plan B, and accept the animal rule, whereby the vaccine is approved on the basis of experimental work, with non-human primates along with very robust safety and immunogenicity trials,” said a clinical trial expert with knowledge of the trial who spoke with Health Policy Watch. 

“So this might have to be the direction here too,” the expert added. “A strategic decision would have to be made. This means having a discussion about the strategy, having a conversation with the regulators, having a plan A and a plan B, and defining a breaking point where you move to plan B.”

Added another expert: “it would make a lot of sense to use the impetus of this outbreak, and the momentum that has been built, to do safety and immunogenicity trials, and then work in parallel on designing different Phase 3 trial [human] types that could be suitable for different types of outbreaks that might come in the future – trials of different intensity and so on, so that everything is ready to start the Phase 3 trials when the next outbreak comes.”

Steering strategic changes at WHO, the big battleship  

WHO Headquarters, Geneva.  Nimble change is not an easy feat in a global organization with over 100 offices and +8,000 employees.

Steering big, strategic shifts in direction, however, is not always an easy task within WHO, which tends to move like a massive battleship: steady and sturdy, but with difficulties in making a rapid change of course.  

Internally, decision making may be further complicated by the fact that Ebola vaccine R&D is currently housed within WHO’s Emergencies team rather than in a research-focused team or department such as the Chief Scientists’ Office, insiders told Health Policy Watch. 

During the 2014-2016 West African outbreak, Dr Marie Paul Kieny, then Assistant Director General for Health Systems and Innovation, personally coordinated WHO’s R&D efforts at testing the first Ebolavirus vaccine (rVSV‐ZEBOV), developed by Merck & Co., which led to US FDA approval.

But Kieny has since left WHO to become director of research at the French National Institute of Health and Medical Research Inserm, as well as chair of the board of Geneva’s Drugs For Neglected Diseases initiative (DNDi). 

WHO’s lines of authority have meanwhile shifted considerably, with Executive Director Mike Ryan, a well-respected authority on crisis response, now put in charge of the current vaccine R&D plan. But Ryan, observers note, is not a research expert.   

“Mike Ryan brings a lot of positive competencies,” one WHO insider said. “I like him. He’s got huge strengths. But this is not one of them.” 

Added another WHO observer, “It’s ridiculous to expect them [Emergencies]  to have that expertise. I mean, would I go to an ophthalmologist if I have appendicitis? No, of course not.”

While some WHO departments house R&D talent, others do not, the researcher noted, saying that a cross-disciplinary approach to managing such research should perhaps be better organized within the agency.  

Recognition of the need to pivot? 

At the same time, the planned 12 January meeting signals that WHO has begun thinking about a new way forward even if it is not saying so publicly just yet. 

“I don’t think anything will be decided, but it’s more about having a meeting of the minds and figuring out what are the options now?” said one stakeholder.

“Putting together a strategy for developing a vaccine in the midst of an outbreak is not an easy thing. As soon as you are able to gain momentum on plan A, the outbreak has shifted and you realize you now need plan B. Outbreaks require constantly adjusting your plans based on where we are in the epidemic curve. It requires having all hands on deck.

“So it will also be important for all parties involved to agree on an appropriate partnership model moving forward. This includes WHO, CEPI, vaccine developers and others. It’s important for all parties involved to have a seat at the table to brainstorm how to move forward in the future for Ebola Sudan vaccine evaluation.”

Vaccine developers moving ahead 

Meanwhile, IAVI as well as Sabin Vaccine Institute say that they are already laying plans for a plan B, if need be, to generate safety and immunogenicity data.  (Oxford could not be reached in time for this story’s publication.)

“Yes, Sabin is currently planning for Phase 2 clinical trials for both our Ebola Sudan and Marburg vaccine candidates. We’ll be happy to share updates on that as details become clearer in the New Year,” Rajee Suri, vice president of communications at the Washington, DC-based Sabin Vaccine Institute, told Health Policy Watch.

And in the case of IAVI, Gupta says that the organization is contemplating different strategies for licensure of its vaccine candidate, including the pathway of FDA’s “animal rule” that would allow for proof of efficacy to be based on trials in non-human primates.

“We’ve been thinking about this development program for a while,” said Gupta, noting that IAVI last year received funding from the US Biomedical Advanced Research and Develompent Authority (BARDA) to advance its vaccine candidate. 

“Even if the ring vaccination trial cannot be conducted as currently designed, we’ll keep moving forward as quickly as we can,” she said.

“We are planning a Phase 1 trial in the US to look at the safety and immunogenicity of the vaccine. And we’re targeting to start in the early part of next year. We are also thinking about safety and immunogenicity studies in Uganda, outside of the ring trial structure,” said Gupta.

“So even if the ring trial is not able to go forward as designed, we will continue with the plan that we developed with BARDA, which does include a number of animal studies and clinical trials.”

Gupta added that IAVI is very familiar with doing clinical trials in Africa. “We have clinical research center partners that we work with in Uganda, with established relationships,” she said. “So we have been talking to those people as well.” 

Can Chief Scientist’s office chart a new direction? 

Sir Jeremy Farrar, is leaving his post as Wellcome director to become WHO’s Chief Scientist in early 2023.

Observers are hopeful that WHO’s incoming Chief Scientist Jeremy Farrar, who has significant research standing and experience, could help steer a new direction in handling thorny questions regarding both the Sudan Ebolavirus vaccine research and similar R&D challenges that are likely to keep emerging in outbreaks. 

“We’re very excited that Farrar is going to be at WHO, we have lots of trust in Jeremy,” one stakeholder told Health Policy Watch.  Farrar will assume the post in the second quarter of 2023, taking over from Soumya Swaminathan, WHO announced last week. 

But along with R&D leadership around the big picture strategies, research “worker bees” also are desperately needed, one senior WHO scientist pointed out. 

Within WHO, pockets of R&D competencies do exist. But they are scattered across different departments – which typically remain siloed and focused on their own research themes – with little cross collaboration in times of need.   

Stockpiling drugs in the field that are ready for deployment

Microscopic image of an ebolavirus – one of a number of deadly filoviruses that cause severe hemorraghic fever.

Regardless of what direction is taken on a Sudan Ebolavirus vaccine trial or organizationally within WHO to manage such R&D collaborations, there is one aspect of the current experience from which WHO and other global health agencies have already drawn lessons. 

That is the need to produce and stockpile drug candidates for neglected but deadly diseases in advance to enable more rapid deployment in moments of need.

Gavi’s CEO Seth Berkley has, for instance, talked about the creation of a stockpile of experimental vaccines that could be housed in ultra-cold freezers around Africa so that they could be mustered almost immediately in an emergency. 

As the experience in Uganda demonstrates, even if the first vaccine candidates arrived in Kampala in a record 79 days after the Ebola outbreak was first declared on 20 September, that is still not fast enough.    

“We should definitely be getting the drugs to the field and developing various clinical trial protocols for various scenarios ready meanwhile, while testing for immunogenicity … so everything is ready to go,” said one WHO clinical trial expert.

Gupta said everyone agrees on the need to have stockpiles of vaccines available and ready to go for all of these different emerging infectious diseases in case of an outbreak.

“When there is no outbreak, we need to ensure that we have adequate funding and resources are allocated so that people can produce the stockpiles, and then have a discussion about where you’re going to keep them, and how you would utilize them if there was a need,” she said. “So we 100% support generating stockpiles and being prepared in advance.”

And while there is no well-defined mechanism for stockpiling vaccine candidates, as such, a stockpile for approved vaccines for the Zaire ebolavirus strain does exist. 

Now, though, the recent outbreak in Uganda has triggered a discussion about the need to extend such a mechanism to vaccine candidates, and particularly for deadly filoviruses like Ebola, as well as Marburg disease, which cause severe and potentially deadly hemorrhagic fever. 

“A number of organizations are involved in these conversations, such as CEPI, GAVI, UNICEF, and the developers,” Gupta said. “We are trying to determine the most efficient path to getting stockpiles on the African continent.”

Paul Adepoju in Nigeria contributed reporting to this story.

Image Credits: Photo by Diana Polekhina on Unsplash, WHO , UNICEF, WHO, MSF/Louise Annaud, AdobeStock, Wikimedia Commons, Megha Kaveri/Health Policy Watch , Brittanica © jaddingt/Shutterstock.com.

HPV vaccine
The WHO has recommended a single-dose regimen for HPV vaccines.

The World Health Organization (WHO) has recommended shifting from a two-dose to one-dose vaccine regimen against the Human Papillomavirus (HPV) – something that could help expand vaccine coverage amongst millions of girls and young women in lower-income regions where HPV is most prevalent, as well as saving costs.  

According to the new WHO recommendation, based on findings by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), the new single-dose schedule provides “comparable efficiency and durability of protection” as the erstwhile two-dose vaccine regimen for girls and young women between the ages of 9 and 20 years old.  An independent advisory group of the WHO had also made a similar recommendation of an alternative single-dose scheduling in April 2022. 

The knock-on benefit is that the shift to a single-dose vaccine should help countries expand immunization coverage more affordably, as well as simplifying the vaccination process for hundreds of millions of girls and young women.   

For women older than 21 years, WHO continues to recommend the two-dose regimen with the second dose within a six-month interval.  Vaccination of boys is recommended where feasible, WHO added in its first update of recommendations on HPV vaccination since 2017. 

Recommendation ‘timely” in light of decline in HPV vaccination coverage during pandemic

“The position paper is timely in the context of a deeply concerning decline in HPV vaccination coverage globally,” said WHO, in a press release Thursday. “Between 2019 and 2021, coverage of the first dose of HPV vaccination fell by 25% to 15%. This means 3.5 million more girls missed out on HPV vaccination in 2021 compared to 2019.”

HPV vaccines prevent sexually-transmitted cervical cancer, which consists of 95% of the cervical cancer cases in women. Cervical cancer is the fourth most common type of cancer in women.  

According to the WHO/SAGE analysis, the efficacy of a single dose of HPV vaccine against “incident persistent high-risk (HPV16/18) infection” was 97.5% for ä single vaccine dose and a double dose alike at 18 months post-vaccination in a randomized open-label trial of 930 females aged 9–14 years, who received 1, 2 or 3 doses of vaccine. At 24 months post-vaccination, over 97.5% of participants in all dose groups for both vaccines were seropositive.

“Immunobridging showed that a single dose of HPV16/18 produced antibody responses that were non-inferior to those in studies where single-dose efficacy was observed,” WHO reported.

Women living with HIV have 3-4 times higher rates of HPV infetion

Based on a 2010 meta-analysis, the global HPV prevalence (all types) among adult women is estimated at around 12%, according to data reported in the recent WHO findings. The highest prevalence was in subSaharan Africa (24%), followed by Latin America and the Caribbean (16%), Eastern Europe (14%), and SouthEast Asia (14%).

A systematic review of HPV prevalence in sub-Saharan Africa found that women living with HIV had a higher prevalence of HPV (54%) and of co-infections with multiple types (23%) than HIV-negative women. A meta-analysis in low- and middle-income countries (LMICs) found an overall HPV prevalence of 63% and a prevalence of high-risk HPV types of 51% among women living with HIV.

Cervical cancer was diagnosed in an estimated 570,000 women across the world in 2018, causing the deaths of around 311,000 women that year, WHO estimates.

In 2020, the World Health Assembly adopted the Global Strategy for Cervical Cancer Elimination. That strategy aims to have 90% of the girls in the world fully vaccinated against HPV by the age of 15, by 2030; the primary target group for HPV vaccination are girls 9-14 year old – before they become sexually active.

According to the WHA strategy, by 2030, 70% of women worldwide should also have been screened for HPV by the age of 35, and then again by the age of 45.  And 90% of the women with pre-cancer or invasive cancer should be treated or managed. WHO Member States must meet the 90-70-90 targets by 2030 to be on track to eliminate cervical cancer within the century.

Image Credits: National Cancer Institute, National Cancer Institute on Unsplash.

COVID-19 cases are surging in China after the country relaxed some of its social distancing and lockdown measures.

China should make full use of all available COVID-19 vaccines to combat its current Omicron surge, according to the World Health Organization (WHO) – including mRNA vaccines that are more effective than China’s Sinovac and Sinopharm vaccines.

“Vaccination is the exit strategy from the impact [of Omicron],” Dr Mike Ryan, WHO head of health emergencies, told the last WHO global press conference for 2022 on Wednesday.

However, given that the Chinese vaccines are less effective than mRNA vaccines, the WHO advises that its citizens need three doses to have the same protection as two mRNA doses – which means that China’s population is under-vaccinated.

While 87% of Chinese people are vaccinated with two shots of the local homologous vaccines, Sinopharm and Sinovac-Coronavac, only 55% have had a third vaccination, according to WHO statistics.

Ryan said that full vaccination would mean three doses of the “available Chinese vaccines as a primary course, not two plus a booster”.

With protective efficacy “hovering a 50% or less” in people over the age of 60, “that’s just not adequate protection in a population as large as China,” stressed Ryan.

“We’ve learned that repeated vaccination with effective vaccines and the appropriate number of doses provides a very high level of protection, especially against severe disease and death,” said Ryan.

A 600% increase in vaccinations

However, he credited China with having made “massive progress over the last number of weeks in rolling vaccines”, saying that there had been a “600% increase or more and vaccination rates over the last week or two weeks”.

Meanwhile, WHO official Dr Rogerio Gaspar told the media briefing that, following a recent meeting with the Chinese authorities, science community and manufacturers, “we are aware of an extensive pipeline of different [vaccine] platforms that are being developed by the science community and manufacturers in China”.

Dr Rogerio Gaspar

At present, the BioNTech-Pfizer mRNA vaccine has only been approved in China for use by German nationals in China, Chinese Ministry of Foreign Affairs spokesperson Mao Ning told a media briefing earlier this month. In exchange, Chinese nationals in Germany have been authorised to take the Chinese vaccines.

“We believe there are discussions going on between the Chinese authorities and some, or at least one, of the mRNA manufacturers around registration of vaccines, and also around the production within China itself, but we’re not privy to those discussions,” said Ryan.

“We would certainly encourage that kind of work both to import vaccines, but also to find arrangements where vaccines can be produced in as many places as possible,” he added. “I do believe the Chinese authorities are pursuing this and it will be better to ask them and the mRNA manufacturers directly.”

China’s information lag

Dr Tedros

WHO Director-General Dr Tedros Adhanom Gebreyesus told the briefing that the global body was “very concerned over the evolving situation in China with increasing reports of severe disease”.

“In order to make a comprehensive risk assessment of the situation on the ground, WHO needs more detailed information on the severity of hospital admissions and requirements for ICU support,” said a somewhat hoarse and tired Tedros.

However, the WHO stressed that it did not believe that China was under-reporting COVID cases and their impact – but simply that their hospital data was lagging behind reality, as had happened in most of the world.

“I think they’re behind the curve about what’s actually happening as everyone is in a situation like this,” said Ryan.

“We need to get better ways of getting that data quickly so we can monitor the situation together because it’s in the interest of the Chinese health system to know where the pressure is in the system at any one time. That allows you to move resources, move PPE, move health workers, move oxygen, move patients,” Ryan stressed.

“We’re very good at detection and doing epidemiological surveillance. We’re not so good around the world at dynamically managing the health system stress during a pandemic.”

However, Ryan indicated that the definition of a COVID death  “is quite narrow” and  “focused on respiratory failure”.

“People who die of COVID die from many different systems failures, given the severity of the infection, so limiting a diagnosis of death from COVID to someone with a COVID-positive test, and respiratory failure will very much underestimate the true death toll,” said Ryan.

“We don’t want the definitions to get in the way of actually getting the right data so we will continue to work with our WHO colleagues in China who work on a daily basis with the National Health Commission in the Ministry of Health and the China CDC, and we will do our best ensure that they can learn lessons about how best to collect dynamic data on health impact during events like this.”

Appeal to China to share data

Dr Mike Ryan

But both Tedros and Ryan appealed to China to share their data so that the WHO could offer more support – implicitly acknowledging that the global body was not being kept abreast with what was happening.

According to modelling by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, China can “expect 323,000 total deaths from COVID-19 by 1 April 2023”, and one million Chinese people could die from COVID-19 next year.

Dr Maria van Kerkhove, the WHO’s lead on COVID-19, said that “by far the dominant sub-lineages of Omicron that are circulating in China are the BA.5 sub-lineages”. These include Omicron BA.5 sub-lineages BQ1, BF7, BA. 2.75 and XBB.

“One of the critical things we have seen with Omicron is that each of these sub-lineages have a growth advantage. They’re highly transmissible, each of these has some level of immune escape, and we do see a similar level of severity of Omicron sub lineages across all of the Omicron sublinear,” said Van Kerkhove.

China may face over a million cases a day, says Airfinity

China is predicted to see two peaks in cases as COVID-19 spreads throughout the country, the first peak in mid-January and the second in early March, according to new modelling by Airfinity based on data from China’s regional provinces.

The Airfinity model, released late Wednesday, estimates case rates could reach 3.7 million a day in a January peak and 4.2 million a day in March 2023.

“Today, our model suggests that there are likely to be over one million cases a day in China and over 5,000 deaths a day. This is in stark contrast to the official data which is reporting 1,800 cases and only 7 official deaths over the past week,” according to the independent health data analysis body.

Airfinity’s Head of Vaccines and Epidemiology Dr Louise Blair says, “China has stopped mass testing and is not longer reporting asymptomatic cases. The combination means the official data is unlikely to be a true reflection of the outbreak being experienced across the country.

“China has also changed the way it records COVID-19 deaths to only include those who die from respiratory failure or pneumonia after testing positive. This is different to other countries that record deaths within a time frame of a positive test or where COVID-19 is recorded to have attributed to the cause of death. This change could downplay the extent of deaths seen in China.”

Image Credits: Flickr.

biodiversity
Global patterns of gene sequence data sharing, June-November 2022. The bigger the dot/higher the number, the more DSI data generated by the country was used by researchers elsewhere.

Along with a pledge to conserve 30% of the world’s biodiversity, the sweeping new deal reached in Montreal on Monday also etches a way forward to create an open-access platform for sharing gene sequences (digital sequence information) as part of new benefit-sharing arrangements. But some observers worry these policy advances still aren’t keeping up with the frenetic pace of technological advances.

The UN Convention on Biological Diversity’s (CBD) historic deal this week has been hailed for its ambitious aims to conserve at least 30% of the planet’s lands, freshwater and ocean resources by 2030, while mobilizing US$200 billion a year to help meet the targets.

Another significant, less understood part of the agreement, is a decision to establish “a multilateral mechanism for benefit-sharing from the use of digital sequence information (DSI) on genetic resources, including a global fund” to be finalized at the next UN Biodiversity Conference in two years.

The text outlines the need for this mechanism to “not hinder research and innovation,” and “be consistent with open access to data” on genetic sequences.  Ensuring open access to such data is something that health researchers and pharma developers have underlined as critical to rapidly responding to emerging threats from potentially dangerous pathogens. Such pathogens are also considered to be part of global biodiversity and fall under the mandate of the CBD. 

Ambitious roadmap, but implementation will be challenging

While the CBD deal, reached at the 15th Conference of Parties (COP15), is regarded as a signal of the direction countries aim to take, hammering out policies that embed open data sharing of biodiversity, particularly of pathogens, into practices, while also ensuring “benefit sharing” from such access will remain a formidable challenge, observers told Health Policy Watch in a series of interviews.

“Unfortunately, DSI technology is light years away from the policy governing it,” said Liz Willetts, an environmental health policy expert from the International Institute for Sustainable Development. “I’m not sure, in practice, the policy will be able to shape industry based on timeline alone.”

When the conference kicked off in Montreal, negotiations on the question of DSI benefits sharing were at a standstill. DSI refers to the digital mapping of DNA or RNA genomes, which enables new product development in areas ranging from cosmetics to vaccines without the physical exchange of biological samples. 

Hundreds of billions of sequences are stored in publicly accessible databases, which are a crucial base of scientific knowledge used extensively by private and public sector researchers alike.

Conservation efforts, medical research, ecosystem restoration, and sustainable agriculture are all heavily reliant on genomes published on public databases.

But the commercial value that genetic materials can generate raises key questions around DSI: who owns these digital sequences, and what constitutes fair compensation for their use in a product like a vaccine or cosmetic?  

In the run-up to the conference, African Union member states and Asia-Pacific countries like India and Bangladesh cited the inclusion of DSI benefits sharing as a non-negotiable part of any final agreement.

Their efforts were successful, making the Kunming-Montreal biodiversity agreement the first of its kind to include language on DSI benefits sharing.

No exception made for pathogens

covid-19
Pharmaceutical companies argue pathogens should be treated differently from other DSI and genetic materials, highlighting the importance of swift and unhindered sharing of the information sequence of SARS-CoV-2.

However, the final text of the agreement does not have any explicit reference to excluding pathogens from the proposed multilateral DSI framework, a key ask by the pharma industry.

In a press statement following the conference, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) expressed concern over the final CBD text on DSI sharing, despite the agreement’s reference to the preservation of open access platforms for such data sharing.

“While it might seem a small detail, the lack of consideration on the fundamental difference between the biodiversity of flora and fauna versus pathogens, including genomic sequence data (or “DSI”) derived from such pathogens, is a problem for all those involved in R&D of vaccines, treatments and diagnostics to fight future outbreaks,” said the IFPMA in a press statement.

IFPMA also emphasized that “ensuring immediate and unhindered pathogen sharing, through a public health exemption to access and benefit (ABS) rules, is critical for the future of public health.”

James Love, a UN advisor and Director of Knowledge Ecology International (KEI), agrees that pathogens should be treated differently – but not in the no strings attached manner advocated for by the pharmaceutical companies.

“The world needs people to share information on pathogens, that sharing is in the interest of everyone. The IFPMA members are keen on others sharing but are not willing to share knowledge assets themselves, so this creates a sense of unfairness,” said Love.

“KEI has recommended that an agreement addresses benefit-sharing more broadly, and not as a condition for sharing pathogens or their digital sequences, but to reward the sharing of anything useful in the response and development of countermeasures, including in addition to pathogens or their sequences, inventions, cell lines, manufacturing know-how, data, etc,” he added.

“We also suggest the money to reward and induce such sharing come from a 1% open source dividend on the sale of vaccines, drugs and perhaps other countermeasures. Negotiators could start by modelling a 1% royalty, and see how that looks.”

Same debate likely to shadow negotiations over WHO Pandemic Treaty

The same debate is likely to shadow the negotiations over the World Health Organization (WHO) pandemic accord, where the linkage between access to pathogens’ genomic codes and benefit sharing is likely to be addressed more directly.  Low- and middle-income countries have already proposed texts that make an explicit link between DSI access and the sharing of “benefits” from medicines or vaccines that are developed as a result.

A “conceptual zero draft” of the proposed pandemic treaty that was circulated to WHO member states in late November outlined the importance of promoting “early, safe, transparent and rapid sharing of samples and genetic sequence data” of pathogens with pandemic potential, and “fair and equitable sharing of benefits arising therefrom.”

Under the draft text, pharmaceutical companies would still have open access to pathogen sequences. But they may also be liable to share financial gains or provide vaccines derived at lower prices depending on the shape of the final treaty. 

“Within a few hours of downloading DSI, COVID-19 candidate vaccines were developed. But in terms of coverage, even after two and a half years we are still lacking,” said Nithin Ramakrishnan, a research scholar at the Center for Public Policy Research, who attended the Montreal conference. 

“Also, many of the [COVID drug and vaccine] purchase agreements have put developing countries into certain kinds of debt traps, including unjustifiable indemnity clauses pledging sovereign assets,” he said. “This is a highly inequitable way of handling benefits generated.”

“Decoupling” DSI from benefits-sharing

Recent advances in technology have led to the exponential growth of gene sequence data stored in online libraries like INSDC.org

Despite the hesitations of pharma, the CBD text pledging open access to gene-sequence information was a relief to the scientific research community, which had voiced worries about losing access to genetic sequence libraries.

The speed at which DSI technology has evolved in parallel with big-data science and artificial intelligence means access to large datasets has become critical to cutting-edge synthetic biology, medical research, and the fields of conservation, ecosystem restoration, and sustainable agriculture, amongst others. 

Scientists have opposed any mechanism based on bilateral agreements between countries on the grounds it would hamstring research and medicine development by placing undue bureaucratic burdens on the process of genetic sequence sharing.

The text of the agreement appears to have heeded these concerns. Along with recognizing the “value of depositing data in public databases” and encouraging the “depositing of more digital sequence information on genetic resources, with appropriate information on geographical origin and other relevant metadata, in public databases,” the treaty makes no mention of bilateral arrangements, instead noting that the “multilateral mechanism” for DSI benefit sharing should be “efficient, feasible, and practical.”

Percentage of DSI on the International Nucleotide Sequence Database Collaboration by country, based on provided sequences.

Negotiations on the exact shape of the multilateral mechanism still have a long way to go. Technical questions remain over whether DSI should be included under the umbrella of “genetic resources” outlined in the Nagoya Protocol – the current treaty covering access and benefits sharing to biodiversity – and how those benefits should be shared without slowing down the speed of DSI sharing remain unanswered. They will be subject to negotiation in the coming months.  

One network of scientists has argued for a “decoupling” of access and benefit sharing – at the research stage – with a mechnaism for sharing benefits at the product commercialization stage only.

In an article published in Nature, the DSI Scientific Network emphasized the importance of creating new benefit-sharing mechanisms that do not limit open access to DSI. 

“This is a fundamental shift away from traditional control-oriented access and benefits-sharing (ABS) to a new idea of OA (open access) and BS (benefit-sharing). This is necessary to protect the many benefits of openness and recognize that benefit-sharing can be accomplished without dramatically altering real-world access,” argued the scientists, representing 33 scientific research organizations working across 55 countries.

“New monetary mechanisms can be put into place upstream of DSI generation (e.g., a micro-levy on DSI-generation reagents and disposables), downstream of DSI use (e.g., a user fee on bio-based products), and/or outside the DSI life cycle (e.g., payment from high-income nation international development funds).“

This mechanism precludes the need to trace the country of origin of the genetic resource from where the DSI was extracted and can support biodiversity conservation and sustainable use without compromising on open access to the resources, DSI Scientific Network scientists said.

“Access to DSI from genetic resources is ‘decoupled’ from benefit-sharing from DSI because payment would not be triggered by access to the databases but rather downstream at the point of commercialization or retail,” study co-author and DSI Scientific Network member Amber Scholz, told the conservation science magazine Mongabay-India,  describing the proposed mechanism.

Low-and-middle-income countries (LMICs) that grant comparatively more access to genetic resources that result in DSI would receive comparatively more funds, said Scholz, of the German-based Leibniz-Institut.

“This mechanism is seen by some as an attractive compromise because it does not require tracking the country of origin of the genetic resource from where the DSI was extracted throughout the value chain but only relies on the entry point of the DSI into the databases,” Scholz said.

Relationship between Nagoya Protocol and new DSI mechanism is not yet known

Even some developing country officials have said that the Nagoya Protocol, which covers the access and benefit sharing of physical and biological samples, doesn’t have to be interpreted to cover DSI. Whether the new mechanism will be its own instrument or an amendment to the protocol will be decided at COP16.

“The access and benefits sharing mechanism implemented in the Nagoya Protocol of the Convention on Biological Diversity is focused on genetic resources, ie, physical material. But DSI is the information obtained through the sequencing of the genome,” KC Bansal, former director of India’s National Bureau of Plant Genetic Resources, told  Indian environment and conservation news site Mongabay 

“Because of advanced technologies, especially omics (the branch of science aimed at the detection of genes), we have been able to convert our physical form genetic resources into DSI. And these DSI are housed in open databases,” said Bansal. Sources with knowledge of Indian negotiations on DSI at COP15 said Bansal’s comments were intended to provide an example of the complexities of defining DSI, rather than reflect India’s official position. 

In this interpretation, DSI does not exist until gene sequencing process happens. This means it would not fall under the language of “genetic materials” outlined in the Nagoya Protocol, and would not be covered by its access and benefit provisions. 

But some access advocates see this as hair-splitting.

“The Convention on Biological Diversity and Nagoya Protocol regulate access to genetic resources. Providing DSI is providing digital access to genetic resources, so whichever way one tries to limit the definition of DSI, the Convention would trigger,” said Ramakrishnan said. “For example, let’s imagine a 3D structure model of some genetic resource is shared, and not sequence info, according to me, the Convention and Nagoya Protocol would kick in.”

The existing ambiguity, though, may serve the interests of some countries by allowing them the freedom to make their own judgements about what genetic resources qualify, or don’t, he noted. 

What is open access, and what will benefit sharing look like? 

The question around open access also looks primed to dominate discussions leading up to the finalization of the DSI mechanism in two years.

Other proposals range from a 1% levy on commercial sales of any product derived from a DSI sequence, to the explicit inclusion of non-monetary benefits such as access to a proportion of vaccines or medicines generated from the DSI, or in the case of beneficial microbes, funding for biodiversity preservation.

“Open access does not mean unregulated or free. Principles of data governance are going to be studied further,” Ramakrishna said. “Without disciplining the way databases behave, it’s very difficult to ensure legal guarantees for benefit sharing.”

Inequalities in the DSI space 

The number of countries to which a country provides DSI is correlated to the number of countries from which it uses DSI, suggesting that there is a positive relationship between providing and using DSI, according to WiLDSI. There are no countries that only provide or only use DSI.

At first glance, discussions around DSI benefits sharing appear to reflect the same goal as recent international agreements on the loss-and-damage fund to offset the impacts of climate change in developing nations made at COP27, and increases in biodiversity funding pledges in the Kunming-Montreal agreement.

But the inequalities relating to DSI are more complex. 

A 2021 study on the use of DSI sequences found that the majority of published sequences do not come from low- and middle-income countries, but from the United States, United Kingdom, China and Canada, who collectively account for 52% of DSI data on the International Nucleotide Sequence Database Collaboration (INSDC), a key set of three global databases. 

But this data is far from complete. Only 16% of sequences in the INSDC have country-of-origin information associated with them. Another 44% of sequences without country data could and should have had country information provided by the submitting scientists, according to a UN Biodiversity document. 

“Practical issues ranging from more expensive access to molecular biological reagents, slower internet bandwidth that limits high-throughput analyses, financial limitations for research funding, limited bioinformatics training and career development opportunities, as well as brain drain, routinely limit those of us working in LMICs,” the DSI Scientific Network article in Nature Communications noted.

“Any DSI benefit-sharing framework must support technical capacity building focused on genomics and bioinformatics,” the scientists said. Based on experiences with the Nagoya Protocol, the sharing of financial proceeds from DSI also cannot be expected to generate transformational financial benefits, they added.

But to date, benefits shared from the commercial development of genetic resources have been effectively limited than the access side of the equation.

“Inequalities in using sequencing technology as well as fairness and equity in benefits sharing from both should be treated with equal importance,” Ramakrishnan said. “The agreement in the DSI is a solution to this. It agrees to share benefits fairly and equitably.”

Edited to correct the date the mechanism will be established. The initial article had confused the dates of COP.16 in Basel, with COP16, the next UN Biodiversity Convention. 

Image Credits: WiLDSI, NIAID-RML , WiLDSI.

COVID-19 is surging after China relaxed its lockdown measures after protests. Chinese protestors hold blank papers to signify censorship.

Schools in Shanghai closed on Monday, as did the US Embassy in Beijing while the streets of major Chinese cities are reportedly deserted as residents retreated from a wave of COVID-19 cases.

In the past week, the country has officially reported over 148,000 new cases – but this is likely to be much higher as it recently relaxed testing requirements. Only two deaths have been officially reported but there are widespread reports on social media about funeral homes being overwhelmed by COVID-related deaths.

While most of its citizens have been under strict lockdowns on and off for the past three years as part of its “zero COVID” strategy, the Chinese health authorities did not roll out sufficient vaccine boosters to its captive audience to ensure more protection against the fast-spreading Omicron variant.

While 87% of Chinese people are vaccinated with two shots of the local homologous vaccines, Sinopharm and Sinovac-Coronavac, only 55% are boosted, according to the World Health Organization (WHO).

Older Chinese who are more vulnerable to serious illness have been particularly resistant to boosters.

But China’s vaccines are only about 60% effective against severe infection in comparison to the over 90% protection offered by mRNA vaccines, and experts recommend a third booster shot to raise their level of protection. 

mRNA Vaccines only for non-Chinese

Last month, US Treasury Secretary Janet Yellen told the New York Times that China had not been interested in importing the US-produced mRNA vaccines, Pfizer and Moderna.

Similarly, Germany had also appealed to China recently to grant regulatory approval to the BioNTech-Pfizer COVID vaccine.

However, Chinese Ministry of Foreign Affairs spokesperson Mao Ning told a media briefing earlier this month that “China and Germany have reached an agreement on providing German vaccines for German nationals in China” – but not for the wider population. In exchange, Chinese nationals in Germany have been authorised to take the Chinese vaccines.

At her weekly briefing on Wednesday, Ning sought to allay fears of widespread COVID cases and deaths, assuring the media briefing that the zero-COVID approach had “provided maximum protection to people’s lives and health” and the country was currently adapting its COVID response measures “to better coordinate epidemic response and socioeconomic development”.

“China is ready to work with the international community to deepen solidarity and cooperation, jointly address the COVID challenge, make greater efforts to protect people’s life and health, promote sound recovery and growth of the world economy, and advance the building of a global community of health for all,” said Ning.

Chinese spokesperson Mao Ning.

Weak vaccines, lack of boosters

“Although there is a high rate of vaccination, comparatively low effectiveness of the vaccines used in China against Omicron and the long duration since vaccination for many individuals mean that 80% of the population is susceptible to Omicron infection,” according to a briefing document from the Institute for Health Metrics and Evaluation (IHME) at the University of Washington.

Based on modelling that includes the implementation of social distancing, the IHME “expect 323,000 total deaths from COVID-19 by 1 April 2023” but warns that one million Chinese people could die from COVID-19 next year.

Although there is a perception that Omicron is mild and will not have a high death toll, “the experience in Hong Kong, however, where 10,000 died in the first months of the Omicron wave, would suggest otherwise”, according to the IHME. 

It describes Hong Kong as a good indicator of what is likely to happen in China, as it has  “similar levels of vaccination with a comparatively poor vaccine and low levels of vaccination in the over-80 population, who are at the highest risk of death”. 

“Over 2022, the infection-fatality rate in Hong Kong was over 0.1% overall.”

The IHME predicts huge numbers of elderly people with severe disease, and hospitals being overwhelmed.

“Strategies to greatly reduce the death toll have been available but not used: switching to the more effective mRNA vaccines and producing or acquiring Paxlovid to manage disease in the vulnerable populations.”

However, Chinese importer Meheco signed an agreement last week with Pfizer to import its antiviral, Paxlovid, according to Reuters. However, there has been no indication that the country will acquire mRNA vaccines although the US has announced that it will make these available to the country if asked.

Currently, Paxlovid is available in China – but often sold out, and with a hefty price, according to Professor John Ji from Tsinghua University in Beijing.

Meanwhile, three Hong Kong-based scientists published in a preprint last week calling on China to implement “fourth-dose heterologous boosting” to 4-8% of the population per week, and ordering enough antiviral treatment to cover 60% of the population, as well as public health measures including social distancing and mask-wearing. 

This would avoid “catastrophically overburdening health systems and/or incurring unacceptably excessive morbidity and mortality” as the country exited its “zero COVID” strategy.

“With fourth-dose vaccination coverage of 85% and antiviral coverage of 60%, the cumulative mortality burden would be reduced by 26-35% to 448-503 per million, compared with reopening without any of these interventions,” according to the researchers, who are based at the WHO Collaborating Centre for Infectious Disease, Epidemiology and Control at the Hong Kong University’s School of Public Health.

Back in May, WHO Secretary-General Dr Tedros Adhanom Ghebreyesus told a media briefing that China’s strategy was no longer sustainable in the face of the more infectious but less lethal Omicron.

“When we talk about the zero-COVID strategy, we don’t think that it’s sustainable, considering the behaviour of the virus now and what we anticipate in the future,” said Tedros, prompting a rebuke from Chinese officials

US President Joe Biden and Secretary of State Antony Blinken participate in the US-Africa Summit in Washington DC.

The US-Africa Leaders’ Summit ended last week with a strong commitment to strengthen Africa’s health systems, tackle food insecurity and climate change.

Meanwhile, top African health officials and scientists meeting at a public health conference in Kigali, Rwanda, at the same time as the summit, vowed to bolster inter-country collaboration to build healthier nations post-COVID.

A vision statement from US President Joe Biden, Senegal’s President, Macky Sall, who chairs the African Union (AU), and AU Commission Chair Moussa Faki Mahamat, affirmed their “shared commitment to prevent, detect, and respond to infectious disease threats.  

“As part of this effort, we will expand our support to strengthen the region’s health workforce, regional manufacturing capacity, and health infrastructure.  We have deepened the partnership between the United States and Africa CDC to achieve our shared global health goals,” according to the statement.

Russia’s war in Ukraine has underscored how the US has lost influence in Africa, with many countries now politically and economically indebted to China and Russia, and the summit was cast as Biden’s attempt to woo African leaders sidelined by his predecessor, Donald Trump.

At the summit, the Biden-Harris Administration announced plans to invest at least $55 billion in Africa over the next three years, and Ambassador Johnnie Carson has been appointed to a newly created position as Special Presidential Representative for US-Africa Leaders Summit Implementation to coordinate these efforts. 

Carson is a former Assistant Secretary of State for African Affairs and has been Ambassador to Kenya, Uganda, and Zimbabwe. 

Stronger workforce and systems

The health components of this plan include support to improve Africa’s workforce, health systems and regional manufacturing.

Through the Global Health Worker Initiative, the US plans to invest $1.33 billion annually from 2022 to 2024 in the health workforce to help “close the gap in health workers, including clinicians, community health and care workers, and public health professionals”.  

Specific plans include training at US universities and research collaborations.

Building on its COVID-19 response, the US has also committed to continuing to build resilient health systems in critical technical areas to strengthen global health security.

The US also reiterated its support to accelerate regional manufacturing for vaccines, tests, and therapeutics, working partly through the President’s Emergency Plan for AIDS Relief (PEPFAR) and the President’s Malaria Initiative. By 2025, PEPFAR wants to procure 15 million HIV tests produced by African manufacturers and to shift at least two million patients on HIV treatments to use African-made products by 2030.

Secretary of State Antony J Blinken

Climate change and food security

Biden reiterated the US support for climate adaptation and resilience announced at COP27 in Egypt, which involves providing over $150 million in new funding to address climate adaptation in Africa under the President’s Emergency Plan for Adaptation and Resilience (PREPARE), supporting “early warning systems, adaptation finance, climate risk insurance, and climate-resilient food systems”. 

The US will also galvanise global public and private investment in African clean energy infrastructure.

The US government and AU also announced new measures to build resilient food systems and diversified supply chain markets to prevent food shocks before they happen.

“The compounding impacts of the global pandemic, the growing pressures of the deepening climate crisis, high energy and fertiliser costs, and protracted conflicts – including Russia’s war in Ukraine – have pushed weak supply chains to the brink and dramatically increased malnutrition and food insecurity — particularly for African countries,” according to the two parties.  

They announced “a new strategic partnership” to deepen their collaboration to increase food production capacity and diversify and strengthen the resilience of food supply chains. 

At the summit, the US foreign assistance agency, the Millennium Challenge Corporation, signed agreements with Benin and Niger to reduce transport costs and lower trade barriers from the Port of Cotonou to Niger’s capital city of Niamey to enhance rural communities’ access to markets to strengthen food supply chains and adapt to climate change.

A similar compact has been signed with Malawi.

In light of the dire drought in the Horn of Africa, Biden also announced $2 billion in new emergency humanitarian assistance. Meanwhile, USAID is also rapidly scaling up food security assistance in Somalia, aimed in the longer run at expanding smallholder farmers’ “access to high quality, climate-smart inputs, and investing in the fisheries sector to diversify local livelihoods,” according to the US.

Opportunities to grow

Michel Sidibe

Meanwhile, at the closing plenary of the Conference on Public Health in Africa (CPHIA) in Kigali, the AU’s Special Envoy Michel Sidibe summarised the key messages, including that Africa must operationalise African Medicines Agency, build African health institutions and platforms,  boost local manufacturing of vaccines and invest in science and building a sustainable R&D ecosystem.

In summarising the plenary sessions, secretariat member Shingai Machingaidze, said that Africa has seen many outbreaks of “high consequence infectious diseases like COVID-19, monkey pox and Ebola, and we were reminded that clinical diagnosis and laboratory confirmation remain major challenges”. 

“While 93% of African countries have a strategy or policy to expand universal health coverage, implementation varies, and the challenges include weak governance, out-of-pocket payments, and over-reliance on donors,” said Machingaidze, who is Africa CDC’s senior science officer.

Shingai Machingaidze

“We were also reminded that Africa manufactures less than 1% of all vaccines manufactured on the continent, and growing Africa’s capacity to manufacture medical tools depends on government commitment and funding, strong public health and regulatory agencies, public-private cross-border partnerships, and owning the patents and licencing,” she added.

Meanwhile, Dr Ahmed Ogwell Ouma, acting director of Africa CDC, urged the delegates to turn lessons and experiences learnt during the COVID-19 pandemic into “opportunities to grow our capacities for prevention and response and strengthen our health systems”.

The conference brought together more than 2500 in-person delegates from 90 countries.

Dr Ahmed Ogwell Ouma, acting director of Africa CDC

Image Credits: Ron Przysucha/ US State Department , Freddie Everett/ US State Department.

World Trade Organization members stretch TRIPS waiver decision.
WTO members agreed to recommend stretching the deadline on extending the TRIPS Decision to COVID diagnostics and therapeutics.

The World Trade Organization (WTO) TRIPS Council agreed to recommend to the General Council, WTO’s highest-level decision-making body, that it extend Saturday’s deadline for deciding on whether to extend an intellectual property rights waiver for COVID-19 vaccines to diagnostics and therapeutics.

The panel’s recommendation on Friday at a formal meeting chaired by Ambassador Lansana Gberie of Sierra Leone effectively put off the decision on whether the June 17 decision by the WTO Ministerial Council to approve a limited waiver on COVID-19 vaccines, should be extended to COVID-19 diagnostics and therapeutics.

After over a year of polarizing debate, WTO ministers had agreed to an IP waiver for COVID vaccines produced in developing countries under the terms of the Agreement on Trade-Related Aspects of International Property Rights (TRIPS) during the MC12 ministerial meeting, attended by some 164 members.

The decision confirmed the right of WTO’s developing nation members to override exclusive patents on COVID-19 vaccines, for a period of five years, due to the public health emergency, including greater flexibility in manufacuring vaccines for export to other developing nations – something that is bureaucratically complex and difficult under the normative TRIPS rules.

However the MC12 postponed a decision on a similar waiver for COVID medicines and diagnostics – saying only that the matter should be decided within six months time.

The TRIPS Council’s agreement to recommend yet another delay in the decision on treatments came after considerable debate and division among trade diplomats, according to a Geneva-based trade official.

Access advocates, in arguing for the expansion of the waiver provisions, have said that COVID treatments are even harder for developing nations to obtain than vaccines. Pharma advocates have argued that numerous generic licenses have already been issued voluntarily. They argue that the real access barriers include the lack of priority accorded to COVID in the health systems of low- and middle-income countries, due to the diminishing impacts of the virus, threats from more deadly diseases, and limited health systems capacity.

No clarity about time frame

Gberie will submit a report saying “the TRIPS Council recommends that the General Council extend the deadline,” but the report apparently does not specify for how long. Gberie credited US Ambassador María Pagán for coming up with the final agreed upon wording for the recommendation to the General Council, which is scheduled to meet on Dec. 19-20 – after Saturday’s deadline has passed.

 

Outcome disappoints everyone  

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) expressed its disappointment that further time and energy will be devoted to a discussion that it said fails to address the real challenges to access.

“Evidence shows there is no reason to extend a waiver on COVID-19 therapeutics and diagnostics,” the global trade federation said. “Instead, if adopted, the proposal will have long-term adverse effects on the current pipeline for COVID-19 therapeutics and for future pandemics. While these discussions continue, the ongoing uncertainty is unwelcome.”

On the other side of the ideological divide, the People’s Vaccine Alliance described it as “shameful” that a decision was not already made to extend the IP waiver to cover the production and supply of COVID-19 diagnostics and therapeutics.

“We are nearly three years into the COVID-19 pandemic. As many as 17 million people are estimated to have died in the time that the WTO has bickered over intellectual property rules for tests and treatments. To say that more time is needed to consider the issue is utter nonsense,” said Max Lawson, co-chair of the alliance and head of inequality policy at Oxfam. “WTO members have decided to let another year pass without making any meaningful contribution to the fight against COVID-19.”

Last week the US Trade Representative’s (USTR) office announced its support for extending the deadline on whether the WTO Ministerial Decision on the TRIPS Agreement should be extended to COVID-19 diagnostics and therapeutics.

The USTR also asked the US International Trade Commission (USITC) to “launch an investigation into COVID-19 diagnostics and therapeutics and provide information on market dynamics to help inform the discussion around supply and demand, price points, the relationship between testing and treating, and production and access”, according to another USTR statement. That investigation could take as long as a year.

Dozens of other nations, including the European Union’s 27-nation bloc, Japan, Singapore, South Korea, Switzerland and the U.K. also have sought more time for the potential waiver extension, saying more evidence is needed to show that intellectual property rules have slowed global access to COVID-19 treatments and tests.

However, developing nations such as India, Indonesia and South Africa have pushed to extend the waiver, arguing it is needed to cover the production and supply of Covid-19 diagnostics and therapeutics so as to broaden global access to drugs that can reduce cases of COVID hospitalization and long-COVID, precisely in those low-income countries where low vaccination rates make people more vulnerable to serious disease.