Teenage TB patients in a hospital in Vietnam.

The days of people with rifampicin-resistant tuberculosis (TB) taking up to 20 pills daily, interspersed with injections,  for up to 20 months might be over.

This follows the release on Wednesday of the preliminary results of a trial of a six-month oral treatment that researchers found to be substantially more effective than the current standard of care.

The TB-Practecal trial tested a six-month regimen of bedaquiline, pretomanid, linezolid and moxifloxacin (BPaLM), against the locally accepted standard of care. 

The trial involved 552 patients at seven trial sites across Belarus, South Africa and Uzbekistan.

“Some  89% of patients in the BPaLM group were cured, compared to 52% in the standard of care group. Tragically four patients died from TB or treatment side effects in the control group,” according to trial leaders Medecins Sans Frontieres (MSF), who revealed the findings at the 52nd Union World Conference on Lung Health.

“Patients were telling us how hard it was to adhere to treatment, but little progress was being made to find kinder treatments because diseases most prevalent in low- and middle-income countries don’t attract investment. So we were compelled to pursue new treatment options ourselves. These results will give patients, their families and healthcare workers worldwide, hope for the future of DR-TB treatment,” Dr Bern-Thomas Nyang’wa, MSF Medical Director and Chief Investigator of the trial, told the Union press conference on Wednesday.

Around 500,000 people develop rifampicin resistant tuberculosis (RR-TB) annually, and this intervention could save lives and substantially improve the quality of life of people with rifampicin-resistant TB.

Genome sequencing

Meanwhile, the conference also heard from researchers who used genome sequencing to effectively predict strains of tuberculosis susceptible to antibiotics that were likely to develop drug resistance.

The researchers looked at drug-susceptible bacteria and aimed to identify mutations that would increase the probability of a bacteria becoming resistant in the future. The mutations confer “pre-resistance”. Monitoring these mutations could prevent the amplification of drug resistance in the population by targeting those bacteria more likely to become resistant. 

We found that isoniazid mono-resistance backgrounds have a much higher risk of acquiring further rifampicin resistance than susceptible backgrounds,” said lead author Arturo Torres Ortiz, a PHD Student at  Imperial College in the UK.

“Rapid molecular tests usually focus on rifampicin resistance, which means that isoniazid mono-resistance is missed. This results in amplification into multi-drug resistance. We thus recommend that rapid molecular tests also identify regions associated to isoniazid resistance-conferring mutations.”

Image Credits: globalgiving.org.

COVAX
COVAX vaccine deliveries in Africa.

The global vaccine facility, COVAX, is on the cusp of delivering large amounts of vaccines to countries that need them the most – but will poorer countries have the ability to properly absorb these?

And how can COVAX ensure that it has the trust of low and middle-income countries (LMICs) who need the vaccines most, given complaints about its lack of transparency by the African Union’s vaccine envoy?

These are some of the issues flagged in a recent review of the Access to COVID Tools Accelerator,(ACT-A) of which COVAX is the most prominent project, with diagnostics and therapeutics forming the other pillars

The global vaccine alliance, Gavi, which manages COVAX, told Health Policy Watch that the coming months “will represent the busiest period of the largest and most complex roll-out of vaccines in history”. 

COVAX’s latest public supply forecast projects that it will have around 1.4 billion vaccine doses ready for delivery by end of year – 1.2 billion for the world’s poorest 92 countries to enable them to vaccinate 20% of their populations.

More support for countries to absorb vaccines

The review recommends “greater downstream support” to help LMIC to absorb more vaccines, something that Gavi says has been addressing over the past few months.

For instance, there has been a massive roll-out of ultra-cold storage facilities as the mRNA vaccines Pfizer and Moderna vaccines need to be stored at very cold temperatures.

“Over the last few months we’ve seen the largest roll-out of ultra-cold chain in history: hundreds of units to 47 countries in under five months,” a Gavi spokesperson said.

However, Gavi added that “ultimately, however, delivery is the responsibility of participating countries and so it is important that countries are able to access all sources of support for delivery”. 

Gavi and its alliance members, including WHO and UNICEF, have been working with many of these countries for two decades, and work closely with national governments and partners to monitor, identify and help to resolve delivery challenges. 

While Gavi acknowledges that new challenges will emerge once doses start arriving in larger volumes, it is “confident at least that systems are in place to ensure that when there is a risk of wastage, to ensure doses are redeployed rapidly to other countries”.

The cold storage facility at Pfizer’s warehouse in Kalamazoo, Michigan.

COVAX undermined by bilateral deals

When COVAX was set up, it declared its aims to be “speeding up the search for effective vaccines for all countries” and “supporting the building of manufacturing capabilities and buying supply, ahead of time, so that two billion doses can be distributed fairly in the places of greatest need, worldwide, by the end of 2021”. 

COVAX aimed to pool investment in candidate vaccines and, if any were successful, become the procurement facility for the entire world, wealthy and poor countries alike. Wealthy countries would pay for their own doses while the Advance Market Commitment (AMC) would use donor funds to help buy vaccines to cover 20% of people living in the world’s 92 poorest countries.

But COVAX was so underfunded that it couldn’t buy enough vaccines, and its paralysis fuelled bilateral deals between pharmaceutical companies and the high-income countries (HIC) that were also COVAX members.

“The critical lesson to be learned from this experience, and the current inequity in access to vaccines between HICs and LMICs, is the need for dedicated resourcing to be in place – before a pandemic occurs,” the Gavi spokesperson told Health Policy Watch. 

“It is notable that, building on the initial $4 billion raised via upfront payments and donor pledges in 2020, the COVAX AMC was only fully funded in June 2021 – by which time bilateral deals between governments and manufacturers had locked up most of the doses available in 2021,” said Gavi.

If funding had been available to COVAX earlier, says Gavi, the facility “would have been able to secure earlier supplies of vaccine from the manufacturers who are currently prioritising those bilateral customers”. 

“This, combined with transparency and accountability from manufacturers on which deals are being prioritised and when, could have avoided many of the supply challenges COVAX has faced to date.”

Gavi believes that it was important to include all countries “given the unknowns” about vaccine development at the start, but it is currently finalising new rules of engagement for the wealthy self-financing countries for next year.

Lack of LMIC representation

A COVAX vaccine delivery of vaccines is offloaded in Abuja in March

The ACT-A review notes “a lack of inclusion and meaningful engagement of LMICs, regional bodies, civil society organisations (CSO), and community representatives” in the ACT-A.

Some LMICs have felt left in the lurch as COVAX has failed to deliver vaccines while those countries that broke ranks and did private deals with pharmaceutical companies 

In July, Strive Masiyiwa, African Union Envoy on Vaccines and head of the African Vaccines Acquisition Task Team, accused COVAX of not being upfront about its vaccine supply problem early enough, resulting in false complacency amongst members who thought their vaccine supply was secure.

Other civil society members have said that COVAX was based on a Western charity model.

Dr Bruce Aylward, the World Health Organization’s (WHO) lead on COVAX, said the concern that the ACT-A Council was not balanced across low, middle and high-income countries “is going to have to be addressed and rebalanced”.

“We need to go back and look at every single one of the engagement mechanisms that already exists…  if it’s not working, we need to fix it,” Aylward told a WHO media briefing last week.

The Global Fund to Fight AIDS, TB and Malaria, which manages the diagnostics pillar of the ACT-A, said that the limitations identified by the review would be addressed by a “revised strategy and budget which is being prepared by the ACT-A partners for publication by the end of October”, a Global Fund spokesperson told Health Policy Watch.

However, Gavi says that lower-income countries are on the Gavi Board and committee structures as well as in the COVAX AMC Engagement Group and the WHO also gives member states regular briefings on COVAX. 

“All of these groups are actively involved in the governance and decision making for COVAX design, strategy and policy,” says Gavi, adding that “each country involved in COVAX has a dedicated team focused on providing tailored information and support, both at the Gavi Secretariat or COVAX Office level as well as via UNICEF and WHO country offices”. 

“These teams liaise directly with country-appointed focal points, usually at ministries of health, and communicate on a daily basis to receive participants’ feedback on various COVAX processes,” said Gavi.

Diagnostics and therapeutics

The review complemented ACT-A’s COVID-19 Response Mechanism (C19RM), which is based on the Global Fund’s well-established health procurement and distribution system, which was already operating in 100 countries. 

To address its three priority diseases – HIV, TB and malaria – the Global Fund had developed wambo.org, an online marketplace for medicines and health commodities that enables  countries to get cheaper prices through pooled procurement.

“When the COVID-19 crisis hit, we opened wambo.org to all countries and organisations so they can access pooled procurement volumes of quality-assured health products, including COVID-19 products,” said the Global Fund spokesperson.

Over 38 million diagnostic tests have already been procured for 90 countries through the Global Fund’s Pooled Procurement Mechanism and wambo.org. Countries could also buy oxygen and PPE on wambo.org. 

While many countries are not doing nearly enough COVID-19 testing, the Global Fund identifies those with the lowest number of tests (less than seven tests per 1000 population per week for 24 months) and offers support to procure rapid tests or laboratory strengthening support.

The review noted that the ACT-A therapeutics pillar “does not yet have a clearly articulated procurement structure to supply countries or to negotiate contracts”.

Tanzanian and US officials celebrate the arrival of the first COVID-19 vaccine donations in the country.

Funding the gap

The review notes that there is a funding gap of $16.6 billion and warns that some of the country pledges to COVAX have not yet been turned into contributions agreements. 

It also recommends that ACT-A should ensure “regular access to up-to-date consolidated financial data to enhance trust and accountability between donors and agencies”. 

WHO’s Aylward puts the shortfall over the next year to be closer to $20 billion “to get equitable rollout” of vaccines, diagnostics and therapeutics to defeat COVID-19. 

“If we go forward next year with the same gaps we had last year, the pandemic will be prolonged,” said Aylward, adding that WHO Director-General Dr Tedros Adhanom Ghebreysus was lobbying G20 finance and health ministers to close the financing gap.

 

Image Credits: UNICEF, Pfizer, NPHCDA.

Researchers describe new findings about TB transmission and diagnosis tools, on the first day of the 52nd Union World Conference on Lung Health

New research published at the opening of the 52nd Union World Conference on Lung Health has demonstrated that routine breathing can transmit tuberculosis even more effectively than coughing – in a finding that also echoes one of the signature lessons from the COVID-19 pandemic about SARS-CoV2 transmission. 

While large droplets jammed with bacteria produced by coughing has long been assumed to be the main course of TB transmission – the new study published on the pre-print server bioRxiv, demonstrates how even more TB bacterium, like COVID, may be transmitted by tinier aerosol droplets released during the course of natural breathing. 

The study by a team of University of Cape Town researchers was just one of a number of new findings released at the opening day of the iconic Union conference – which is meeting virtually for the second year in a row. 

Other new findings released in the first day of the three day, global event (19-22 October)  include a new gene-based blood-prick test for initial TB screening – particularly useful for children who do not produce sputum-filled coughs; and the use of face masks to capture, and screen for, TB and multi-drug resistant tuberculosis (MDR-TB)  as yet another novel diagnostic tool.   

But it is the new study on aerosol TB transmission that is one of the most revolutionary – challenging the fundamental dogmas around TB transmission. Using sensitive measurement devices, the study documents how so-called ‘tidal breathing’ – routine inhalation and exhalation by a TB-infected person – will typically release over 90% TB bacteria (Mycobacterium tuberculosis –Mtb), over the course of a routine day – as compared to only 7% by coughing. 

That’s partly because an infected person will simply breathe many more times  – some 22,000 times in fact, as compared to about 500 coughs.  In contrast to the large droplets released by a cough, most of the bacteria released by breathing are in the form of tinier aerosols, which can remain suspended in the air and travel much further as well. 

Findings on Aerosols Echo lessons from SARS-CoV2 – But Research Preceded the Pandemic 

The signature findings echo lessons learned from the COVID pandemic – where the big aerosol transmission risks of SARS CoV2 have now been well acknowledged – despite fierce resistance among some experts – including at the World Health Organization – in the pandemic’s early days.   

They also illustrate why traditional public health measures such as better housing, less crowding, and improved ventilation may deserve more attention in modern TB control – strategies that have perhaps been too often sidelined to the shadows by modern drug therapies.

Despite the comparisons, the research team at the University of Cape Town has been studying the aerosol transmission of TB long before COVID appeared on the horizon, asserted the study’s lead author, Ryan Dinkele, in a press briefing on Tuesday morning.  

They did so with the help of a device developed by Robin Wood, another University of Cape Town researcher and study co-author, which can more sensitively detect the bacteria in aerosols emitted by a TB-infected person’s breath or cough.

“We have been working on this technique for a long period of time,” Dinkele said. “We did chat about whether we should implement our system for COVID. COVID came across our lines during this process.”

Conference sheds light on a neglected disease 

Tereza Kaseva, director of the WHO Global TB Programme

The three-day conference on lung health, attended by several thousand specialists and policymakers from around the world also casts its net on a wider array of respiratory diseases  – including pneumonia, asthma, chronic obstructive pulmonary disease (COPD) – and COVID-19.  Sessions also will address the two biggest environmental risk factors for lung health – tobacco smoke and air pollution.

However, most of the conference’s attention is focused on TB, which paradoxically remains one of the deadliest diseases on the planet, despite the fact that it is also one of the oldest.  And the COVID pandemic has only made that worse – dramatically reducing the number of TB-infected people who are being diagnosed and treated in 2020 – according to the latest Global TB Report, released by WHO just last week. 

“TB remains critically underfunded,” said Tereza Kaseva, director of the WHO Global TB Programme. “Global spending on TB is $5.3 billion, less than half of the $13 billion annually that we need,” she stressed, saying that the world urgently needs to invest in new TB diagnostics, treatments, and ultimately, vaccines.     

Additionally, TB is a “social disease” whose transmission is facilitated by poverty and marginalization, making it a disease endemic to many migrant groups and informal communities, she and others emphasized.  

Co-morbidities of TB & COVID are unexplored

Uvistra Naidoo, South African pediatric doctor and TB/COVID survivor

“TB is grossly underfunded, and that is why we are behind in the race,” said Uvistra Naidoo, a pediatric doctor and himself both a TB and COVID survivor. Not only governments are to blame, however, he added: 

“When I compare with HIV or cancer,” he added, “there is a lot more activism that happens on behalf of the patient in the latter.”

The COVID pandemic has only added fuel to the fire in another way – not only shifting resources but also saddling many former TB patients, like himself, with additional COVID disease risks.

Those co-morbidities are still poorly understood, said Naidoo who knows this from bitter first hand experience.

After beating drug resistant TB in a difficult three-year battle –  he came down with COVID in 2020, and continues to battle the effects of long COVID today.

“I picked up severe COVID-19 twice,” he said, speaking at The Union session with the aid of a nasal oxygen cannula.

“I’ve got complications to my heart, my lungs, and my adrenal glands recently. We’ve just found out and as you can see, I’m still intermittently oxygen dependent,” said Naidoo. He described how COVID, when it struck South Africa, infected almost everyone in his family  – as well as many in his professional community.

“I’ve lost a father, I’ve lost 25 medical colleagues, doctors and nurses. I’m beyond humbled. I think the courageous thing that we can show the general public out there is that to actually just describe with the TB front and the COVID-19 front, that we don’t know what we’re doing just yet.” 

Image Credits: Roche , The Union .

taliban afghanistan polio
Visiting one neighbourhood after the other to vaccinate Afghan children against polio is the hope to eradicate the disease.

The World Health Organization and UNICEF welcome the decision made by Taliban to support the resumption of house-to-house polio vaccination across Afghanistan.

The vaccination campaign, which begins 8 November, will be the first in over three years to reach all children in Afghanistan, including more than 3.3 million children in some parts of the country who have previously remained inaccessible to vaccination campaigns.

A second nationwide campaign has also been approved and will be synchronized with Pakistan’s own polio campaign in December.

WHO officials have said that this is an “extremely important step in the right direction.” 

“We know that multiple doses of oral polio vaccine offer the best protection, so we are pleased to see that there is another campaign planned before the end of this year.  Sustained access to all children is essential to end polio for good.  This must remain a top priority,” said WHO Representative in Afghanistan Dapeng Luo.  

Both WHO and UNICEF have made joint calls in August for the establishment of a “humanitarian airbridge” for the sustained and unimpeded delivery of much-needed medicines and supplies to millions of people in aid, following the rise to power of the Taliban. 

Taliban seeks international recognition with polio campaign 

Though WHO has called the resumed campaign a much-needed step forward, others have pointed out the Taliban’s desperate grab for international recognition.

“The Taliban are desperately seeking international recognition, that is for sure.  And, for that, they do seem to be trying to behave in a much civilized manner,” said Thomson Reuters journalist Shadi Khan, who has also contributed to Health Policy Watch.

Khan pointed out the efforts of the international humanitarian community in weakening the Taliban’s stance on polio vaccines, though these efforts are at odds with other extremist groups in the region.

“Over the past few years, the Taliban’s stance on polio vaccines has softened drastically thanks to the untiring efforts of the humanitarian community in engaging people at grassroots for awareness and immunization in Afghanistan as well as in the neighbouring Pakistan. However, hardliners among the Taliban and other extremist groups such as the so-called Islamic State Khorasan and others are seriously opposed to the vaccines as they see it part of the West’s alleged conspiracy against Muslims. Such individuals and groups continue to have significant clout in Afghanistan and can orchestrate deadly attacks even against mainstream Taliban like in a Kabul mosque”.

With opportunity to eradicate wild poliovirus, vaccination remains crucial 

Inactivated polio vaccine

With only one case of wild poliovirus reported so far in 2021, Afghanistan now has an opportunity to eradicate polio.

Pakistan and Afghanistan, both members of the WHO Eastern Mediterranean Region, are the only two polio-endemic countries in the world. 

While cases have declined dramatically, when compared to the 56 reported cases in 2020, surveillance continues to remain an issue in Afghanistan. 

This means that restarting the polio vaccination campaign remains crucial to preventing any significant resurgence of polio within the country and mitigating any potential risk of cross-border and international transmission. 

“This decision will allow us to make a giant stride in the efforts to eradicate polio,” said Hervé Ludovic De Lys, UNICEF Representative in Afghanistan.  

“To eliminate polio completely, every child in every household across Afghanistan must be vaccinated, and with our partners, this is what we are setting out to do,” he said.

In addition to the polio vaccine, children aged 6 to 59 months will also receive a supplementary dose of vitamin A in the months during the upcoming campaign. 

UN, WHO engaging with Taliban in supporting immunizations

The violence in Afghanistan has taken a toll on an already fragile health system.

The polio programme has already begun making preparations to rapidly implement the nationwide vaccination campaign, in the midst of ongoing high-level dialogue between the UN, WHO, and the Taliban. 

WHO officials have called it a win not only for Afghanistan, but for the region as a whole as it works to achieve wild poliovirus eradication.

“The urgency with which the Taliban leadership wants the polio campaign to proceed demonstrates a joint commitment to maintain the health system and restart essential immunizations to avert further outbreaks of preventable diseases,” said Dr Ahmed Al Mandhari, WHO Regional Director for the Eastern Mediterranean. 

WHO Director General Dr Tedros Adhanom Gheybreyesus noted last month that engaging with the new government is necessary to support the people of Afghanistan during this time, when the overall health system of the country remains vulnerable.

All parties have agreed on the need to immediately start measles and COVID-19 vaccination campaigns, which will be complemented with the support of the polio eradication programme and other outreach activities that will urgently begin to deliver other life-saving vaccinations. 

For their part, Taliban leaders have promised to remove “impediments” to aid, to protect humanitarian workers, and to safeguard aid offices, according to a 15-point proposal addressed to the UN’s humanitarian aid coordination arm, OCHA, and signed by the Taliban’s acting minister of foreign affairs, Amir Khan Muttaqi.

Image Credits: Canada in Afghanistan/UNICEF/Flickr, Flickr – Sanofi Pasteur, British Red Cross/Twitter.

WHO, other UN and humanitarian agencies recruited hundreds of staff to respond to DRC’s 2018-2020 Ebola response who received little or no real training in how to prevent and respond to sexual exploitation and abuse.

The World Health Organization would allocate some US$ 15 million annually to ramp up training programmes for WHO staff and consultants in the Prevention of Sexual Exploitation and Abuse (PSEA), beginning with ten countries that have the “highest risk” profile, according to a draft plan under discussion with member states. 

The proposed “Management Response Plan”, presented to WHO member states in a closed door meeting last week, will focus on “putting the victim and survivor at the heart of prevention and response to SEA,” said a WHO spokesperson, who shared new details of the plan with Health Policy Watch on Monday.

The WHO plan  was developed in response to the recent findings of an Independent Commission that found widespread WHO staff and consultants supporting the agency’s response to the 2018-2020 Ebola outbreak in the eastern Democratic Republic of Congo had raped, harassed, and traded sex for jobs and other favours with Congolese women.  

“The findings reported by Independent Commission are horrifying,” the spokesperson added, echoeing statements made by senior WHO officials when the Independent Commission’s findings were first published. “WHO apologises unreservedly to the victims and survivors of these appalling events, as well as to their families and communities. 

“WHO is committed to ensuring the survivors get the support and assistance they need.  WHO will take every measure in its power to bring perpetrators to account, including referring to and collaborating with relevant national authorities on any criminal proceedings.”  

Accountability in reform of WHO culture  

Gaya Gamhewage, WHO director of Prevention and Response to Sexual Exploitation and Abuse, at the 28 September press briefing on the findings of the Independent Commission.

The new plan outlines a series of “immediate” actions to be taken between mid-October and end March 2022, including: “completing investigations, taking urgent managerial action and launching a series of internal reviews and audits,” the spokesperson said.

Medium term, from mid-November 2021 to end December 2022, the plan will prioritize: 

  • Embedding a “victim- and survivor-centred approach, framework and services”;
  • Establishing and enforcing “accountability and capacity of WHO personnel, managers and leaders for prevention and response to sexual exploitation, abuse and harassment (PRSEAH)”; 
  • Reform of WHO structures and cultures. 

A new PSEA focal point has already been dispatched to the eastern DRC, which reported its second Ebola case last week following the end of the 2018-2020 epidemic that struck Ituri and North Kivu provinces.

Other countries to be immediately prioritized for the training include: Afghanistan, the Central African Republic, the Democratic Republic of the Congo, Ethiopia, Nigeria, Somalia, South Sudan, Sudan, Venezuela, and Yemen, WHO said. 

Prevention was just a Box to be “Ticked” – Former UN worker tells Health Policy Watch 

The Commission’s findings, published last month, found that some 83 emergency responders to DR-Congo’s 2018-2020 Ebola outbreak, including at least 21 WHO employees and consultants, had likely abused dozens of Congolese women, obtaining sex in exchange for promises of jobs, as well as raping nine women – some of whom later became pregnant and gave birth. 

https://healthpolicy-watch.org/humbled-and-horrified-who-reacts-to-findings-on-dr-congo-sexual-abuse-but-will-high-level-who-officials-accused-be-investigated-too/

The Commission was formed in the wake of an investigation by The New Humanitarian and Thomson Reuters Foundation in September of 2020, which found evidence of widespread sexual abuse among the WHO and other UN responders – who used their positions of power to leverage sex from DRC women. 

The epidemic was a perfect storm for such abuse since the same UN agencies and humanitarian groups that had hired hundreds of local and international workers to respond to the deadly emergency also  failed to provide any real training in the sensitive balances of power that their new jobs entailed, one former UN PSEA counselor told Health Policy Watch in an interview.   

“It was a tick, it was a tick box exercise of like, Oh, we’ve got someone doing it, someone’s attending the meetings,” said the former UN worker, who asked not to be identified.

She said the lack of sensitivity to the risks of sexual exploitation by men freshly hired and empowered by their jobs was widespread among UN and humanitarian response groups – although WHO as the largest agency on the ground, also became the lightning rod for spreading rumors about abuse. 

Ebola response activities in DRC involved the massive recruitment of new WHO and UN staff – who received little or no training in how to use their positions of power in workplace relationships.

Senior UN Agency heads displayed little interest in the quality or extent of preventative training offered to the new response teams – leaving it to a handful of PSEA focal points to design and execute their own programmes. 

“I’d go out in person, and explain what is the difference between sexual harassment and sexual exploitation and abuse, and why that’s not the same; what is ok and what is not ok, and what the reporting mechanisms are; and what we mean by zero tolerance,” the former PSEA worker said.  

“But they [my supervisors] never even asked me about anything that I did until the New Humanitarian article came out.  By that time, I’d already left. I’d finished my contract – but suddenly they were interested in what the f-k, I was doing this whole time?” 

Plan to be developed as a three-year strategy  

Following feedback from member states, WHO’s new abuse and exploitation prevention plan is due to be published within the next few days.   

But it will remain a “living document” “drawing on the learnings during its implementation as well as on the experience of other UN Agencies, partners and Member states,” the WHO spokesperson said.

Ultimately, WHO will develop a full-fledged three year strategy, for the years 2023-2025, the spokesperson said. 

“WHO has allocated an initial US$7.6 million to immediately strengthen its capacity to prevent, detect and respond to SEA, in ten countries with the highest risk profile: Afghanistan, the Central African Republic, the Democratic Republic of the Congo, Ethiopia, Nigeria, Somalia, South Sudan, Sudan, Venezuela, and Yemen,” the spokesperson said.   

“WHO is also committing additional funds to address the longer-term surge in capacity that we need to implement the MRP. An initial estimate is that we’ll need about US$15 million a year, but we are still working on the details,” the spokesperson added. 

 

Image Credits: WHO AFRO, WHO AFRO/Twitter, WHO.

Sputnik V Vaccine

South Africa has decided not to grant approval to Russia’s Sputnik V COVID-19 vaccine as there is a risk that it might make vaccinated men more vulnerable to HIV infection, the South African Health Products Regulatory Authority (SAHPRA) announced on Monday.

SAPHRA’s caution stems from fact that Sputnik uses an Adenovirus Type 5 (Ad5) vector as one of the delivery mechanisms for its vaccine. 

A few years back, two trials of a candidate vaccine for HIV that also used an Ad5 vector were found to make men more susceptible to HIV infection.

After the two HIV vaccine trials – called STEP and Phambili – were abandoned, researchers concluded during follow-up that men with “pre-existing Ad-specific neutralising antibodies” were particularly vulnerable to HIV infection after being vaccinated. 

Sputnik uses two different adenovirus vectors to deliver each of its two-dose COVID-19 vaccine, Adenovirus Type 26 (Ad26) for the first dose and Ad5 for the second.

Concerns about Ad5-based vaccine 

STEP and Phambili researchers Susan Buchbinder and colleagues cautioned against the use of an Ad5-based vaccine for COVID-19 in an article published a year ago in The Lancet.

Buchbinder notes that a 2013 consensus conference on Ad5 vectors sponsored by the National Institutes of Health “warned that non-HIV vaccine trials that used similar vectors in areas of high HIV prevalence could lead to an increased risk of HIV-1 acquisition in the vaccinated population”.

South Africa has one of the biggest HIV positive populations in the world – over eight million people – and almost 20% of people aged 15 to 49 are living with HIV.

SAHPRA has been considering Sputnik’s application since February and, in light of the HIV trials, it “requested the applicant to provide data demonstrating the safety of the Sputnik V vaccine in settings of high HIV prevalence and incidence”, said the body’s CEO, Dr Boitumelo Semete, in a statement. 

“The applicant was not able to adequately address SAHPRA’s request,” she added.

After reading Buchbinder’s article and consulting local experts, SAHRA decided not to approve the Sputnik vaccine “at this time”. 

“SAHPRA is concerned that use of the Sputnik V vaccine in South Africa, a setting of a high HIV prevalence and incidence, may increase the risk of vaccinated males acquiring HIV,” said the statement.

“The rolling review of the Sputnik V vaccine will, however, remain open for submission of relevant safety data in support of the application.” 

No WHO approval yet

The World Health Organization (WHO) has also not given Sputnik Emergency Use Listing (EUL) yet.

Mariangelo Simao, WHO’s Assistant Director-General for Access to Medicines and Vaccines, said last week that the “Sputnik process is still on hold it pending some legal procedures that we expect will be sorted out quite soon”.

“We are working very almost on a daily basis with the Ministry of Health in Russia to address the remaining issues to be to be fulfilled by the applicant, the Russian Direct Investment Fund (RDIF),” Simao told the WHO’s weekly COVID-19 media briefing.

“As soon as this letter of agreement is signed, WHO will reopen the assessment, which includes the submission of the data in the dossiers – it’s still incomplete – and resuming the inspections in the sites in Russia,” she said.

However, she said she did not know how long the process would take as it would depend first on finalising the legal procedure, then an assessment of both the applicant and vaccine manufacturers.

The RDIF applied for EUL for Sputnik back in February but the process has been dogged with problems. Initially, the RDIF had not submitted all the required data. More recently, WHO inspectors flagged a number of concerns when they visited manufacturing sites in Russia, including control of aseptic operation and filling.

Earlier this month, a representative from the European Medicines Agency told the New York Times that Russia had repeatedly postponed planned inspections of the Sputnik manufacturing sites.

At the time of publication, the RDIF had not responded to a request for comment on South Africa’s decision.

Sputnik has been approved in 70 countries, according to the company. These are mostly countries that are politically aligned with Russia, or that have few other vaccines choices.

Meanwhile, the RDIF has announced that it will be seeking approval for what it calls “Sputnik Light”, a single dose of the vaccine that only uses the Ad26 vector to deliver its antigen.

The company is promoting it as a potential booster shot for “vaccines produced by AstraZeneca, Sinopharm, Moderna and Cansino”, according to a media release.

China’s Cansino also uses an Ad5 delivery method for its vaccine.

Football star Didier Drogba and WHO Director-General Dr Tedros Adhanom Ghebreyesus. 

Football star Didier Drogba aims to use his new position as the World Health Organization’s (WHO) Goodwill Ambassador for Sport and Health to promote healthy lifestyles, especially to young people.

“Many people do not have access to health services and non-communicable diseases such as heart disease, stroke, diabetes are rising globally,” the former Chelsea striker and Cote d’Ivoire captain told a media briefing in Geneva on Monday.

“Furthermore, the world faces grave, complex and evolving challenges in addressing poverty alleviation, climate change, and tackling COVID-19 recovery efforts,” said Drogba.

“In this role as WHO Goodwill Ambassador, I am determined to work in partnership with WHO, FIFA, civil society, the youth, the private sector, and other sector stakeholders to reach out to as many football fans as possible, using sport as a powerful educational and fun field to promote messages on the benefits of physical activity and other healthy lifestyles, and highlight the value of sports, particularly for youth.”

Previously, Drogba was a United Nations Development Programme Goodwill Ambassador, focusing on development issues in Africa between 2007 and April 2021, and has also taken part in various campaigns relating to healthy lifestyles, anti-malaria and HIV.

“Didier is a proven champion and game-changer both on and off the pitch,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. 

“We are pleased to have him playing on our team, and helping communities worldwide reach and score goals through sports for their physical and mental health and well-being. He will also support the mobilization of the international community to promote sports as an essential means for improving the physical, mental health and social well-being of all people, including in helping COVID-19 recovery efforts.”

Current global estimates show 80% of adolescents and a quarter of all adults, do not do enough physical activity. Regular physical activity, including through sports, helps lower blood pressure and reduce the risk of hypertension, coronary heart disease, stroke, diabetes, and various types of cancer.

Drogba’s announcement as a WHO Goodwill Ambassador was made during a ceremony to launch the “Healthy 2022 World Cup – Creating Legacy for Sport and Health” partnership between Qatar’s Ministry of Public Health and its Supreme Committee for Delivery and Legacy, WHO and world football’s governing body, FIFA.

Qatari Health Minister Dr Hanan Al Kuwari

 

Zika virus under a microscope

Some 70 cases of Zika virus were identified in India’s Kerala State over the course of July – what represents the first cases to be reported in the southern Indian state, said WHO on Thursday.

WHO provided no explanation as to why the report was first published months after the outbreak was initially identified. Subsequently, on 31 July, Maharashtra state also reported its first Zika laboratory-confirmed case, said the WHO’s Disease Outbreak News. Asked by Health Policy Watch why the first WHO report was delayed by five months, a WHO spokesperson said he could not provide an immediate response.

But the report follows warnings by Indian researchers that the spread of Zika virus amid COVID-19 in India represents a ‘rising concern.‘

The outbreak was first identified on 8 July when a 24-year old pregnant woman near Pune was diagnosed with the virus, said the WHO report.  Subsequent wider testing identified some 70 cases, including four additional pregnant women.

The WHO report followed upon another last week of a new Ebola virus case in the Democratic Republic of Congo’s North Kivu region – only a few months over the DRC’s last Ebola oubreak was declared over in May.

Zika (ZIKV) can cause large epidemics that strain public health systems, and pose big risks to diagnosis and treatment.  Diagnosis requires sufficient laboratory capacity to differentiate ZIKV disease from illness due to co-circulating aedes mosquito-borne viruses like dengue and chikungunya, according to WHO.

Although 60-80% of the Zika virus infected cases are asymptomatic or only have mild symptoms, ZIKV can cause microcephaly and congenital Zika syndrome (CZS) in newborns and infants. Moreover, although ZIKV is primarily transmitted by the Aedes species mosquitoes, it can also be transmitted from mother to foetus during pregnancy, through sexual contact, transfusion of blood and blood products, and organ transplantation, according to WHO.

A young child infected with Zika virus – affordable, rapid testing remains a challenge.

Zika virus first gained prominence in early 2015 when a major outbreak occurred in Brazil.  It spread rapidly to dozens of other Latin American and Caribbean countries, and in 2016 the outbreak was  declared by WHO to be a public health emergency of international concern (PHEIC).

In India, Zika virus disease cases/infections have been detected in Gujarat, Madhya Pradesh and Rajasthan states in 2018 (South-East Asian lineage).

While this marked the first time that the virus had been detected in the souther state of Kerala, WHO said, adding that “this event is not unexpected, given the wide distribution of the primary mosquito vector, Aedes aegypti, and competent vector, Aedes albopictus, in Kerala and Maharashtra states.”

Image Credits: ECDC – europa.eu, UNICEF.

In Pakistan, a healthcare worker listens to a child’s lungs for signs of tuberculosis.

Deaths from tuberculosis increased for the first time in a decade in 2020 due to the COVID-19 pandemic, according to the World Health Organization’s (WHO) 2021 Global TB report. 

The diversion of health resources to address COVID-19 led to fewer TB diagnoses as well as a drop in treatment last year. This is likely to result in even higher TB-related deaths in 2021 and 2022, warned the report, which was released on Thursday.

Over a million fewer people were diagnosed in 2020 than the previous year with the south-east Asia and Western Pacific region accounting for 84 % of the global reductions. India and Indonesia were responsible for more than half of the drop in case notifications in this region between 2019 and 2020. 

The most sobering part of the report was its warning that negative impacts on TB mortality and TB incidence in 2020 will be even worse in the next two years, with 2021 forecast to have even higher TB deaths while 2022 is likely to see the biggest impact on TB incidence. The pandemic and lockdowns have knocked TB’s elimination progress to 2012 levels. 

Fewer case notifications, dip in treatment 

Most 2020 targets set for TB elimination have been missed by almost all WHO regions. The WHO Europe region, which achieved and surpassed most of its 2020 targets, faltered when it came to TB notification and registered a dip in notifications. 

The number of new TB case notifications globally was 5.8 million in 2020, whereas the figure for 2019 was 7.1 million.

The huge drop in reporting and detection of TB between 2019 and 2020 points to a disruption in the supply-and-demand of TB diagnostic and treatment services, the report said. Fewer people were able to get access to resources due to lockdowns and fears of COVID-19, and the healthcare system also took a hit due to the diversion of resources. 

The WHO estimates that 4.1 million people who currently suffer from this deadly disease have not been diagnosed or have not officially reported to national authorities. The figure was 2.9 million in 2019.

India and Indonesia had previously been the main contributors to the uptick in TB notifications between 2013 and 2019 when their combined annual total number of notifications increased by 1.2 million in that period. However, all that was nearly erased between 2019 and 2020 when notifications fell by 0.7 million. 

According to the Indian Health Ministry’s 2021 Annual Report on tuberculosis elimination, reports and notification of confirmed TB diagnoses tumbled 38 % in March-April 2020 owing to the lockdown. Private notifications were down 41 % for the same period. 

At the press conference to launch the report, Katherine Floyd, Coordinator of the TB Monitoring and Evaluation Group in the WHO Global TB Programme, said that India has the highest TB burden in the world. In 2020, some 2.6 million people developed TB while half a million people died – one-third of all global deaths. 

Treatment, deaths and intervention

Based on the country-specific models for 16 countries that accounted for most of the global drop in 2020, the negative impacts on TB mortality and incidence will get worse in 2021 and beyond. 

The organisation estimated that approximately 1.5 million people died in 2020 from the air-borne disease, the first year-on-year increase in global deaths due to TB since 2005. 

The models of prediction for these figures have not considered the economic and nutritional aftermath of the Covid-19 that makes individuals more susceptible to developing TB diseases among those already infected with M.tuberculosis. 

How do we get back on track? 

“Getting back to the levels that were achieved in pre-COVID times would depend on the key stakeholders, officials, funders and the understanding that these investments and continuation of TB services are needed as soon as possible,” said Dr Tereza Kasaeva, WHO’s Director of the Global TB Programme, in response to a question from Health Policy Watch.

She said that urgent actions and investments are key to address these gaps in TB’s progress and a full recovery of services is essential. 

Dr Osamu Kunii, Head of Strategy, Investment and Impact Division at the Global Fund to Fight AIDS, Tuberculosis, and Malaria, said that “we need a global effort to support replenishment of the global fund for next year.” 

He added that while the G7 and G20 members are having discussions on pandemic preparedness, we need to remind them that “fighting against TB is also very useful for future pandemic response.” 

Funding woes and missed targets 

The drop in people enrolled on drug-resistant TB treatment means that the target of treating 40 million people by 2022, which was adopted at the 2018 UN-High level meeting, is far out of reach.

“This is alarming news that must serve as a global wake-up call to the urgent need for investments and innovation to close the gaps in diagnosis, treatment and care for the millions of people affected by this ancient but preventable and treatable disease,” cautioned the WHO Director-General Dr Tedros Adhanom Ghebreyesus. 

Increases in both domestic and international funding for TB are urgently required, but provisional data suggest that allocations for 2021 will remain inadequate, according to WHO. 

“For more than a year now, we’ve been sounding the alarm over the growing number of people not being diagnosed and treated for TB,” said Dr Lucica Ditiu, Executive Director of the Stop TB Partnership.

“Unfortunately, today’s report confirms what we all feared—that more and more people are dying from TB. We now see more than 4,100 people dying from TB every single day. This is not a prediction; it is a reality. The COVID-19 pandemic combined with low political will and appallingly low levels of funding have reversed hard-fought gains in the fight against this age-old disease.”

Funding in the low-and middle-income countries that account for 98% of reported TB cases show an 8.7% decline last year 2020. The $5.3 billion spent in 2020 is less than half of the global target of $13 billion annually by 2022 and only 39% of the target amount estimated to be needed in 2020 in the Stop TB Partnership’s Global Plan to End TB, 2018–2022. 

The End TB Strategy targets for 2030 and 2035 cannot be met without intensified research and innovation, the report further said. 

There need to be more technological breakthroughs by 2025 so that the global incidence rate of TB could be accelerated to 17 % per year between 2025 and 2035. With the 2020 target for TB incidence missed, one will need to make bigger strides to meet the future targets. 

“If we had spent a fraction of the energy and money that governments and pharma have spent developing COVID-19 vaccines and then getting them to wealthy countries, we´d have stopped TB in its tracks long ago,” said Guy Marks, President of the International Union Against Tuberculosis and Lung Disease (The Union). 

“Instead, these devastating mortality numbers from the WHO Global TB Report indicate TB will return to being the biggest killer sooner than later. And that is a preventable tragedy.” 

The report lists priorities to meet the 2025 targets, including a TB vaccine or a new drug treatment for the nearly two billion people already infected, rapid diagnostics for use at the point of care, and simpler, shorter treatment for TB disease.

 

Image Credits: Stop TB Partnership.

South Sudan’s Minister of Health, Elizabeth Chuei, getting vaccinated against COVID-19.

Africa is estimated to have seven times more COVID-19 cases and three times as many deaths as officially reported, according to the World Health Organization (WHO) Africa region.

This means that the continent could have around 59 million cases and 634,500 deaths.

“We’re using a model to estimate the degree of under-estimation. Our analysis indicates that as few as one in seven cases is being detected, meaning that the true COVID-19 burden in Africa could be around 59 million people,” said Dr Matshidiso Moeti, WHO’s Africa executive director.

 “The proportion of underreporting on deaths is lower. Estimates such as around one in three deaths have been reported. Deaths appear to be low on the continent, in part because of the predominantly younger and more active population,” she told a media briefing on Thursday.

The case figure was extrapolated from country-based seroprevalence surveys while the mortality figure was reached on the basis of excess death statistics, said WHO’s team lead on operational partnerships, Dr Thierno Balde.

“With limited testing, we’re still flying blind in far too many communities in Africa,” conceded Moeti. 

The WHO recommends that member countries should perform 10 tests per 10,000 people each week yet around 20 countries – more than a third of African countries – do not reach this benchmark, said Moeti.

“Most tests are carried out on people with symptoms, but much of the transmission is driven by asymptomatic people. Estimates suggest that between 65% and 85% of COVID-19 cases are asymptomatic. The reported cases we see could therefore just give the tip of the iceberg,” she added.

Dr Matshidiso Moeti, WHO Africa Executive Director.

Community-based testing

The WHO has thus decided to invest $1.8 million to roll out COVID-19 rapid tests in hot spots, starting with pilots in eight countries including Senegal.

“The community testing initiative is a radically new approach, which shifts from passive to active surveillance through working with communities, local authorities and hotspot districts,” said Moeti.

“We will use antigen detection, rapid diagnostic tests which are reliable, affordable, easy to use, and provides results in around 15 minutes.”

People living within a 100-metre radius of a case in various hotspots will be eligible for a free test and the WHO expects to reach over seven million people.

The WHO hopes that, by identifying potential spreaders early, countries will be able to break the chain of transmission and contain flare-ups – particularly as the continent expects a surge in infections during the festive season in December when there is a lot more movement of people.

“This community testing strategy is a key component in transitioning towards localised management of COVID-19 outbreaks,” Moeti stressed.

Deaths lower in Africa

Despite the mortality undercount, WHO Africa officials said that deaths appear to be low on the continent.

Moeti attributed this in part to the continent’s “predominantly younger and more active population”. 

Balde added that the continent also had a relatively low prevalence of the co-morbidities such as diabetes and hypertension that had made COVID-19 fatal for many people.

“There are also some hypotheses mentioning the existence of viruses and linked to the coronaviruses that some Africans have been exposed to over the years,” added Balde.

However, only a minority of African countries have accurate statistics on excess deaths.

Zero vaccinations

Only three countries in the world have not yet started to vaccinate their citizens against COVID-19 despite WHO engagement and support, including the Africa states of Burundi and Eritrea.

However, Balde said that Burundi was expected to start to roll out vaccinations within the next few weeks as the country had recently joined the African Vaccine Acquisition Trust (AVAT) and signed a contract with COVAX.

However, he said that WHO was still working in Eritrea and doing advocacy “on all levels”.

Only 4.9% of Africans have been vaccinated against COVID-19, said Moeti.

Image Credits: UNICEF.