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

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

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

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

Lack of availability

WHO Access to Medicines Technical Officer Jane Hedman

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

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

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

Pharma flags regulatory and health system barriers

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

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

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

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

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

Pfizer CEO Dr Albert Bourla

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

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

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

Call for transparency

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

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

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

Lack of testing

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

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

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

Danger of drug-on-drug interactions

WHO’s Janet Diaz

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

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

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

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

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

Image Credits: Pfizer .

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

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

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

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

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

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

Linking UHC with a pandemic instrument 

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

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

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

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

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

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

Lack of UHC legal and financing frameworks 

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

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

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

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

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

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

Pandemic treaty offers an opportunity to advance UHC 

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

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

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

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

A ‘Global Fund’ for UHC?  

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

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

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

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

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

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

Solidarity as a principle

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

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

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

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

Barriers to UHC

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

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

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

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

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

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

 

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

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

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

Africa CDC director John Nkengasong

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

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

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

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

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

Fifth wave

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

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

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

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

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

 

COVID-19 vaccine is being administered to a woman in Iran.

Some 42% of the World Health Organization’s (WHO) Eastern Mediterranean is fully vaccinated, but only five of the 22 member states have met the global goal of vaccinating 70% of their populations despite enough vaccine stocks being available, according to a media briefing on Wednesday.

WHO Region Director for Eastern Mediterranean, Dr Ahmed Al-Mandhari, ascribed the low vaccine rate in some countries to the reach of the vaccine campaigns, and vaccine hesitancy among populations.

The region includes a number of countries wracked by war and conflict, including Afghanistan, Sudan, Somalia, the Occupied Palestine Territory and Yemen.

The vaccination rates vary hugely from 99% in the United Arab Emirates all the way down to 2.1% in Yemen.

Meeting the global COVID-19 vaccination targets remains a priority in the Eastern Mediterranean region even as they registered some of the lowest reported cases and deaths in the region since the pandemic began, according to Al-Mandhari.

The region had 21.7 million confirmed cases of COVID-19 and 324,000 deaths up to 16 April, but the transmission rate remains a matter of concern, the WHO said. 

The region also saw a 21% decrease in new cases and a 24% decrease in deaths, but Al-Mandhari warned member states not to let their guard down, especially with pilgrims and tourists expected to arrive in the region in the coming months. 

“While the trends may seem encouraging, it is important to note that we have seen an increase in the number of new cases in two countries and an increase in deaths in six countries,” he said.

“Transmission remains high, vaccination coverage remains low in several countries, and the relaxation of public health and social measures is still being widely observed, allowing continued transmission and the risk of new variants emerging.” 

Dr Ahmed Al-Mandhari, WHO Regional Director for the Eastern Mediterranean.

“Extensive use of multiple booster doses in a small number of countries will not end the pandemic. The global and regional priority is to achieve full protection of the highest priority groups in all countries with full vaccination and a booster dose first, and then advance to lower priority groups based on vaccine supply and health system capacity,” said Al-Mandhari, adding that 9% of the region had been boosted.

Preparing for hajj pilgrims, FIFA World cup 2022

The Region is set to welcome and host a number of mass gathering events, including umra and hajj pilgrims in Saudi Arabia in July, and the FIFA World Cup in Qatar in November. These events are set to welcome over a million pilgrims and tourists from around the world and concerns remain on the COVID-19 situation and spread with such events.

When asked about COVID-19 precautionary measures in the region in the run-up to the World Cup, the WHO tols Health Policy Watch that they were working closely with the Government of Qatar and FIFA on this very issue. 

Dr Richard Brennan, Regional Emergency Director, said that the WHO was working with the regional authorities to do its best to adhere to the protocols but there was no guarantee that there would be no cases of COVID-19 infections.

“We’ve learned enough from this virus to indicate that we cannot guarantee that[spreading] but I can assure you that as many of the most appropriate measures that can be taken are being taken out in the lead up to the World Cup, and we hope to keep it as virus-free as possible,” said Brennan.

Image Credits: Johnson & Johnson, Wikimedia Commons, WHO Eastern Mediterranean Region .

Pollution in Delhi peaks in late autumn when drifting emissions from crop burning exacerbate the usual urban household, traffic and industrial sources

India’s air quality data, removed at the last minute from the WHO Air Quality database update just prior to its launch two weeks ago, has been restored again to the online repository. 

The omission of data from dozens of cities in one of the world’s most polluted nations went unnoticed by major media until it was reported last week by Health Policy Watch.

At the time, WHO sources denied that any pressure had been applied by the Indian government to suppress or alter the data.  Rather, the India data was deleted from the online database so as to perform a final data check that was somehow overlooked in the lead-up to the launch. 

“The World Health Organization, after a thorough review, have now included the Indian cities, and have taken immediate steps to update this on its WHO web site, and in the database,” a senior WHO scientist told Health Policy Watch. 

WHO’s belated inclusion of Indian cities to its 2022 update covering air quality in 6,000 cities and settlements around the world, was noted Tuesday by Indian media and air quality advocates:

“Indian cities have finally been added by @WHO to its latest #airpollution report. Nine of the top 15 most polluted places are in India in the last 3 years,” tweeted Chetan Bhattacharji, senior managing editor at India’s NDTV station.  

“After several phone calls and emails, the mystery remains unsolved, but at least the data is back,” said the non-profit group Care for Air. “Data transparency is data democracy. And transparency precedes awareness and action.”  

The data still reveals a glum national situation for India. Although Lahore, Pakistan; Kabul, Afghanistan and Hetian Shi, China rank as the three most polluted cities in the world, they are closely followed by eight Indian urban centres – Delhi included.  

Air Pollution value for Delhi unchanged, but some others reflect refinements  

PM2.5 values for Delhi and a number of other major cities were largely unchanged in the final, published WHO data set, as compared to the embargoed version of the data, which was dropped at the last minute from the WHO 2022 database launch on 4 April, but published by Health Policy Watch last week. 

Comparisons of values for major Indian cities in the 31 March, embargoed WHO database and the final dataset released on 19 April. (Health Policy Watch compilation from WHO datasets)

The now updated Indian dataset does include other significant technical refinements. For instance, data for large Indian cities from the Indian government’s Central Pollution Control Board (CPCB), the statutory authority responsible for monitoring air quality is now incorporated more fully.  

Previously, data for Delhi and a number of other large Indian cities had been attributed only to the US AirNow programme, which monitors air quality from its missions and embassies around the world – but is not an official government data source. 

In a few cases, the final inclusion of the CPCB data actually led WHO to report on higher pollution values.  

For instance, in Agra, the annual average of PM 2.5 air pollution concentrations for 2019 was 109.67 µg/m3 – about 17% higher than the 91 µg/m3 value included in the embargoed dataset. The final data also includes more CPCB monitoring points – covering some 85% of the city. 

Other corrections included the elimination of duplication in the Indian names Bangalore (British spelling) and Bengaluru (Indian) – with the British spelling chosen as the reference. Data from Haryana, the Indian state that surrounds Delhi on three sides, was deleted. While that is presumably because Haryana is a state and not a city, that reduces valuable perspective of air quality in a strategically important farm area – where smoke from rice stalk burning drives heavy pollution into Delhi in the late autumn. 

WHO-led BreatheLife campaign site offers an interactive search experience for air pollution data from cities globally. Here, results  for Delhi – along with estimated deaths/year in India from air pollution.

WHO database ‘not designed to derive trends’ in developing cities over time  

Although WHO’s air quality database was a bold move for the global health agency when it was first established over a decade ago – one significant limitation of WHO’s urban air pollution reporting today is the lack of analysis of trends in major cities over time.  WHO produces no such analysis for cities – even though more than a decade’s worth of ground station monitoring data is now available. 

“The WHO database has never been intended to derive trends,” in the cities that it tracks over time, the WHO scientist told Health Policy Watch. 

“Even with the historical data that is included, it is difficult to do such type of analyses for many reasons (based on the same limitations highlighted for intercity comparisons).” 

Nonetheless, other global experts are indeed looking at trends at national and urban level – and particularly in large cities seen as drivers of change, both good and bad. 

One example is a paper on trends in developing country megacities, published on 8 April in Science Advances.  It concluded that rising air pollution levels are driving a rise in air pollution-related mortality in African and South Asian megacities – where policymaker action on polluting vehicles, urban sprawl, home and power plant emissions – has been slow, if it happens at all.  

That analysis, which also references satellite sources, notes that observations of Aerosol Optical Depth (AOD) values reflect growing PM2.5 pollution in South Asian cities over the past decade. AOD is the level at which aerosols prevent light traveling through the atmosphere and is thus an indicator of PM2.5 concentrations. 

“Trends in AOD from 2005 to 2018 in South Asian cities are steep (2.5 to 7.8% a−1) and significant. AOD more than doubles in Bangalore (7.8% a−1) and Hyderabad (7.3% a−1),” report the authors from University College London, Harvard School of Public Health, the University of Birmingham and University of Brussels.  

“Earlier studies have reported similar positive trends for these cities, so our contemporary record supports sustained rapid growth in AOD (and thus PM2.5),” the authors say, adding that: 

“Desert dust likely does not contribute to trends in AOD over South Asian cities, as desert dust optical depth has declined over the Thar Desert and makes a negligible contribution to AOD trends across the rest of India.”  

Increase in premature deaths due to increase in exposure to PM2.5 in rapidly growing tropical cities. Bars give the increase in premature mortality in 2018 relative to 2005 for the top 15 cities, colored by the percentage point change in fraction of premature deaths attributable to exposure to PM2.5. Inset value is the total for the cities in Fig. 1 with detectable trends in AOD. (Science Advances)

Politicians in Asia and Africa also have often tried to blame high air pollution levels on either natural dust or biomass burning, related to household cooking, charcoal production or wildfires. 

However, the Science Advances article draws out multiple lines of evidence suggesting that other “anthropogenic” sources from vehicles, energy production and industry represent a growing piece of the pollution puzzle.

Notably, six African cities including Abuja, Ibadan and Conakry Nigeria, have exhibited “very steep increases in anthropogenic activity NO2” the authors note, referring to another health-harmful air pollutant, nitrogen dioxide closely associated with vehicle emissions. NO2 levels are rising at time when biomass burning, a traditionally prominent source of air pollution in Africa, is on the decline, the authors note.    

WHO planning global trends analysis update 

Along with avoiding trend analysis, WHO has discouraged using the data to make comparisons between cities – saying it’s main message is to encourage better monitoring altogether.

While it’s true that considerable technical inconsistencies in monitoring methods can make inter-city comparisons challenging, critics say that the real bigger barrier is political. As a member-state body, studies that lead to unflattering comparisons between member states puts WHO in an extraordinarily uncomfortable position.

WHO has in the past undertaken trend analyses – but with a focus more at the global or global and regional level. The latest such WHO paper, a hybrid analysis of both ground station monitoring and satellite data from 2010-2016, was published in Nature in 2020. It found that one-half of the world’s population are being exposed to increasing levels of air pollution. 

(Nature 2020) Graphic a: Average annual PM2.5 (μg/m3) Concentrations in 2016. b: Changes in PM2.5  concentrations 2010-2016 show South East Asia and Africa with the most rapid increases (in pink and red).

“We intend to publish an update of it, with the 2020 data early next year,” said the WHO scientist involved in the previous paper.  

In addition, the scientist added: “WHO has recently established a Global Air Pollution and Health Technical Advisory Group (TAG) which brings together over eighty of the top experts on the health and air pollution, working to better quantify the health risk from air pollution, and to provide guidance on quantifying the costs and benefits of different interventions to tackle air pollution, among other [tasks]. 

“The TAG will advise and support WHO on the relevant analysis and trends to be developed.”

See the exclusive Health Policy Watch analysis of the database here:

EXCLUSIVE: WHO Deleted India’s Air Pollution Data from its New Air Quality Database – Why? 

 

 

Image Credits: Flickr, Compiled by Health Policy Watch from WHO data , Science Advances, April 2022 , Nature (2020).

Airline easyJet had to cancel hundreds of flights as a result of a rise in COVID-19 cases in staff. It abandoned mask-wearing last month.

The Biden administration will no longer enforce its mask mandate for travel after a federal judge in Florida struck down the US Centers for Disease Control and Prevention (CDC) mandate for planes, buses and trains Monday afternoon. 

US District Court Judge Kathryn Kimball Mizelle ruled in favor of the Health Freedom Defense Fund which had initiated a lawsuit against the federal government in July 2021, stating that the mandate has “exceeded the CDC statutory authority.”  

“It is indisputable that the public has a strong interest in combating the spread of COVID,” Mizelle wrote. 

However, Mizelle also controversially claimed in her ruling that “wearing a mask cleans nothing” and that “at most, it traps virus droplets. But it neither ‘sanitizes’ the person wearing the mask nor ‘sanitizes’ the conveyance.”

The World Health Organization (WHO) recommends wearing a mask “as part of a comprehensive strategy of measures to suppress transmission and save lives”.

She ruled that the mask mandate exceeded the CDC’s statutory authority, declaring it unlawful as the CDC failed to explain its reasoning for the mandate.

“Because our system does not permit agencies to act unlawfully even in the pursuit of desirable ends, the court declares unlawful and vacates the mask mandate,” Mizelle ruled.

White House press secretary Jen Psaki had called the ruling “disappointing” at a White House briefing, citing the recommendation by the CDC to continue wearing masks in public transit.

“What we announced last week was just a two-week extension in order to have time to assess what we’ve all seen is rising cases, and make an assessment and recommendation with that in mind.” 

The federal ruling was initially set to expire on 3 May to allow more time to study the COVID-19 BA.2 Omicron subvariant now responsible for the vast majority of US cases. 

The US Department of Homeland Security (DHS), which would be implementing this ruling, and CDC are currently reviewing the decision. 

US airlines make masks optional

mask
Hartsfield–Jackson Atlanta International Airport in Georgia, US. Airlines across the country have opted to make masks optional following Florida ruling.

This ruling has quickly reshaped US air travel, as numerous carriers – Delta, United, Southwest, American, and others – have now said that masks are optional for travelers aboard aircraft. 

The massive shift means that airline employees also no longer have to wear masks and won’t have to enforce the rule on passengers. However, airlines also warn that travelers should still bring masks on trips to conform with the rules for where they land, especially for international flights. 

“To mask or not to mask, the choice is yours,” said Frontier Airlines on Twitter. 

While masks may be optional onboard, airlines such as Delta have warned that masks may be “inconsistently enforced” as the news is being “broadly communicated” over the next 24 hours.  

“Communications to customers and in-airport signage and announcements will be updated to share that masking is now optional – this may take a short period of time.” 

Delta had expressed optimism about the ruling, adding, “We are relieved to see the US mask mandate lift to facilitate global travel as COVID-19 has transitioned to an ordinary seasonal virus.” 

Other airlines have noted that they will be ready to respond to future COVID surges, should the need arise.  

“We are confident we will be ready to respond if faced with another COVID wave or even a new virus,” said Alaska Airlines.  

International airlines face canceled flights amid rising cases  

While airlines and passengers across the US are celebrating the end of mask mandates on flights, international flights have seen COVID-19 cases rise and flights cancelled following the removal of masks a month earlier.

More than 200 flights were cancelled by budget-friendly Swiss airline easyJet over the weekend, and more than 60 flights on Monday, with the airline blaming the cancellations on staff shortages caused by COVID-19. 

An easyJet spokesperson said: “As a result of the current high rates of COVID infectious across Europe, like all businesses, easyJet is experiencing higher than usual levels of employee sickness.” 

“We have taken action to mitigate this through the rostering of additional standby crew this weekend, however, with the current levels of sickness, we have also decided to make some cancellations in advance which were focused on consolidating flights where we have multiple frequencies so customers have more options to rebook their travel, often on the same day.

EasyJet made the move to not require masks on flights earlier in March, following the United Kingdom’s removal of all travel restrictions earlier in March. 

British Airways has also cancelled a small number of flights due to staff sicknesses during the Easter holiday weekend. 

Image Credits: Ben Queenborough/PinPep )F;oclr_, risingthermals/flickr.

A destroyed tank is abandoned on the road to Bucha, Ukraine.

Getting medical supplies and equipment to those Ukrainians who need it as fighting intensifies is one of the World Health Organization’s (WHO) biggest concerns, according to WHO Europe spokesperson, Bhanu Bhatnagar on Tuesday.

“An increase in fighting could further threaten our supply chains in and out of affected areas.,” said Bhatnagar, who is currently in Lviv, a Ukrainian town near the Polish border.

“To mitigate this risk, we plan to ramp up our donations to the Ministry of Health, assess the possibility of pre-positioning supplies in additional locations to help build a network of warehouses, for example in Poltava to serve the north and east, and Odessa to serve the south,” he added.

WHO has so far delivered 218 metric tonnes of emergency and medical supplies and equipment to Ukraine. Of that amount, 142 metric tonnes – roughly two-thirds – have reached their intended destinations, mostly in the east and north of the country where the need is greatest.

The WHO has a large storage facility in Lviv, some 65km from the Polish border, but the town – which had been a refuge for those fleeing fighting elsewhere – was targeted by Russian missiles on Monday, and may no longer offer a safe place for WHO supplies.

Generators and oxygen

The global body is also trying to get 15 generators delivered to hospitals across Ukraine this week, including to Mariupol, Kharkiv, and Luhansk and Donetsk oblasts but will only do so “when we can ensure the safety of our personnel and the precious cargo they are transporting”, said Bhatnagar.

“Patient care is heavily dependent on access to reliable power supply. Even a momentary power failure can have serious consequences for patients, for example, those needing medical oxygen,” he added.

In addition, only 10 oxygen plants are still able to supply hospitals and health services, and WHO is working on contingency plans with the Ministry of Health to address any disruptions.  

To date, the WHO has verified 147 incidents of attacks on health care in Ukraine, in which at least 73 people have died and 52 have been injured. Of these, 132 attacks have been on health facilities and 16 on ambulances.

Rape survivor training

WHO Europe has also been providing technical support to Ukraine to assist it to align its clinical protocols on health services for survivors of sexual violence with WHO guidelines and developing training curricula for primary health care providers on the clinical management of rape in humanitarian settings, according to its latest situation report.

This comes amid numerous reports of systemic rape of Ukrainian women and children by Russian soldiers.

The Executive Director for UN Women, Sima Bahous, told a recent UN Security Council briefing that the increasing reports of sexual violence and human trafficking in Ukraine — allegedly committed against women and children in the context of massive displacement and ongoing fighting — are raising “all the red flags” about a potential protection crisis.

Warning that “this trauma risks destroying a generation”, Bahous added that women make up 80% of all health and social care workers in Ukraine, and many have chosen not to flee as they want to help their communities.

The WHO has also hosted a webinar for pulmonologists in Poland to increase awareness and update them on the treatment approaches in Ukraine, especially on drug-resistant tuberculosis (TB).

Meanwhile, a case of highly contagious bacterial infection, diphtheria, has been confimed in  Donetsk oblast. 

Image Credits: Marco Frattini/ World Food Program.

There have been isolated case reports of SARS-CoV2-induced hepatitis in adults. Displayed here is a liver sample from a 34-year old SARS-CoV2 infected man displaying mild hepatitis inflammation, from a report published in May, 2021.

The World Health Organization has reported that it is investigating some 74 cases of acute childhood hepatitis, of an unknown origin, in the United Kingdom along with five suspected and confirmed cases in the Republic of Ireland.

That follows on previous reports of similar, severe hepatitis cases of an unknown origin among a cluster of nine children in the United States, as well as three children in Spain.

Oddly enough, WHO’s first “Disease Outbreak News (DON)” announcement of the mysterious hepatitis outbreak, which is puzzling scientists and healthcare providers, did not make any mention of the US cases already under investigation by the US Centers for Disease Control.

Altogether, some 91 children in the USA and Europe have now been reported to be confirmed or suspected ill, with the mysterious, and potentially deadly disease, since January.

That includes nine children in Alabama, 3 in Spain, and at least 74 in England, Scotland and Northern Ireland, according to a report from the University of Minnesota’s, Center for Infectious Disease Research and Policy (CIDRAP). Another five cases, confirmed or possible, have been reported in the Republic of Ireland, WHO also said on Friday.

The acute infections appear to be mostly associated with circulating adenoviruses – the viruses responsible for the common cold – rather than known hepatitis virus strains, US investigators have said.  But SARS-CoV2 has also been detected in several cases, WHO noted in its DON.

“Laboratory testing has excluded hepatitis type A, B, C, and E viruses (and D where applicable) in these cases,” the WHO said.  It added, however, that “Severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) and/or adenovirus have been detected in several cases,” the WHO said.

“The United Kingdom has recently observed an increase in adenovirus activity, which is co-circulating with SARS-CoV-2, though the role of these viruses in the pathogenesis (mechanism by which disease develops) is not yet clear,” WHO added.

“Following the notification from the UK, less than five cases (confirmed or possible) have been reported in Ireland, further investigations into these are ongoing. Additionally, three confirmed cases of acute hepatitis of unknown aetiology have been reported in children (age range 22-month-old to 13-year-old) in Spain. The national authorities are currently investigating these cases,” WHO added. It made no mention, however, of the outbreak in the USA.

According to the WHO report, children present to healthcare providers with markedly elevated liver enzymes, often with jaundice, and they sometimes have gastrointestinal symptoms, including vomiting. At least 6 of the 74 UK patients required liver transplants.  So far no deaths have been reported.

The US CDC has said that it is working with Alabama on its investigation into the cases, as well as with other state health departments to see if there are cases elsewhere.

In a separate statement, The Alabama Department of Public Health, said that it had been investigating the increase in hepatitis cases in young children since November 2021.

“These children presented to providers in different areas of Alabama with symptoms of a gastrointestinal illness and varying degrees of liver injury including liver failure. Later analyses have revealed a possible association of this hepatitis with Adenovirus 41.

“To date, nine children less than 10 years old have been identified as positive for adenovirus and two have required liver transplants. The affected children were from throughout the state of Alabama, and an epidemiological linkage among them has not been determined. None of these children has had any underlying health conditions of note.”

There have been isolated case reports of acute hepatitis developing in SARS-CoV2 in young, and previously healthy adult patients. Some degree of liver injury has also been described among people hospitalized for severe COVID-19.

See the full WHO Disease Outbreak News report here.

Image Credits: F1000research.com.

The latest study on the effectiveness of a second COVID-19 booster, published last week in the New England Journal of Medicine, has shown that within a period of two weeks to one month after receiving the jab, recipients’ infection rates dropped by one-half and severe cases and deaths by three-quarters.

The study, conducted by Israel’s Clalit Research Institute in collaboration with researchers at Harvard University in Boston, is also one of the largest studies of the fourth jab to date – analysing data of more than 364,244 individuals -182,122 who received the second booster and the same number who did not.

The study also was conducted between January 3 and February 18, during the height of Israel’s Omicron wave – pointing to the continued effectiveness of at least the Pfizer mRNA COVID vaccine against that new, and more infectious variant.

“The results of the study can help each person make an informed decision about the need for a vaccine according to personal risk,” said Prof. Ran Balicer, Chief Innovation Officer for Clalit Health Services.

“Currently, one of the main reasons for hesitation regarding receiving the fourth vaccine dose is a lack of information regarding its effectiveness,” added Prof. Ben Rice, head of a predictive medicine group at Boston’s Children Hospital and Harvard Medical School. “The careful epidemiological research presented before us provides reliable information regarding the effects of the vaccine.”

According to the results, those who received the second booster dose experienced a 52% reduction in all infections; a 61% reduction in symptomatic infection; 72% reduction in hospitalizations; a 64% reduction in severe disease; and a 76% reduction in deaths compared to those who had only been vaccinated with the third dose (first booster), at least four months earlier.

“A fourth dose of the BNT162b2 vaccine was effective in reducing the short-term risk of Covid-19–related outcomes among persons who had received a third dose at least 4 months earlier,” the study concluded.

Western countries push fourth dose for most vulnerable

A second booster is equivalent to the fourth shot for anyone who took a Pfizer or Moderna mRNA vaccine regimen. For those who received Johnson & Johnson, it means the third shot. Most countries recommend it four months or more after receiving the first booster.

In January, Israel became one of the first countries in the world to recommend a second booster for people over the age of 50 and immunosuppressed individuals. Since then, a handful of other countries – mostly in the Western world – have followed suit.

In March 2022, the US Food and Drug Administration authorised a second shot for its elderly (over 50) and vulnerable populations, which was soon after endorsed by the Centers for Disease Control and Prevention.

Germany has approved the fourth dose for people over the age of 60 and the United Kingdom recently advised the shot for people over the age of 75.

The European Centre for Disease Prevention and Control (ECDC) and European Medicine Agency’s COVID-19 task force said earlier this month that while it is “too early to consider using the fourth dose of mRNA COVID-19 vaccines in the general population,” they recommend the fourth dose for adults over 80 “after reviewing data on the higher risk of severe COVID-19 in this age group and the protection provided by a fourth dose.”

The ECDC and EMA also noted that there is ”no clear evidence in the EU that vaccine protection against severe disease is waning substantially in adults with normal immune systems aged 60 to 79 years and thus no clear evidence to support the immediate use of a fourth dose.” However, they said that a re-vaccination campaign could start as early as the fall.

“So far, no safety concerns have emerged from the studies on additional boosters,” they said.

Earlier studies show similar results

The Clalit study follows a handful of other reports on the fourth shot, all conducted in Israel, most of which have been peer-reviewed.

A study published earlier this month, also in the NEJM, looked at the rate of infection and severe illness in more than a million Israelis over the age of 60 who received a fourth dose. It found that the rate of COVID-19 infection was initially two times lower among those getting a second booster, than among those who had only received a third dose. Protection against infection, per se, appear to wane quickly, that study found. while protection against severe illness appeared more sustained. The new study, carried out within a longer time frame, reinforces those findings.

“Rates of confirmed SARS-CoV-2 infection and severe Covid-19 were lower after a fourth dose of BNT162b2 vaccine than after only three doses,” the study using Israeli Health Ministry data concluded. “Protection against confirmed infection appeared short-lived, whereas protection against severe illness did not wane during the study period.”

Fourth COVID Vaccine Jab Provides Little Extra Protection to Healthy Individuals – NEJM

Fewer benefits for younger individuals

A separate study by researchers from Sheba Medical Center at Tel Hashomer, published only a few weeks earlier, focused on healthy healthcare workers. Significantly, that study, which also assessed the effectiveness of the fourth shot, found that it provides ““little protection, if any, from infection by COVID-19 among vaccinated young and healthy individuals in comparison to those vaccinated with only a third dose,” the lead researcher said.

That study included approximately 600 volunteers, among them 270 who received a fourth shot of either the Moderna or Pfizer vaccine. All of the volunteers had received three shots of the Pfizer vaccine prior to the trial.

Finally, a non-peer reviewed retrospective cohort study – this one also published in collaboration with Clalit Health Services – was published at the end of March. Of 563,465 members of the fund, 328,597 (58%) received a second-booster dose during the 40-day study period.

“Death due to COVID-19 occurred in 92 second-booster recipients and in 232 participants who received one booster dose,” the authors reported, translating to a 78% reduction in death compared to those who only received one booster.

“The main conclusion is that the second booster [fourth shot] is lifesaving,” Dr Ronen Arbel, Health Outcomes Researcher at Clalit Health Services and Sapir College, told Health Policy Watch.

Image Credits: Clalit Health Fund .

Nathalie Strub-Wourgaft, DNDi Director of COVID-19 Response & Pandemic Preparedness and coordinator of the ANTICOV consortium looking at COVID treatments in low-income settings. 

Nathalie Strub-Wourgaft, a senior scientist at the Drugs for Neglected Disease Initiative (DNDi) has a vision that could be critical to halting the next pandemic – but is esoteric, difficult to organize and even more challenging to build the trust and buy-in needed to make it really work. 

The vision is of a common clinical-trial archives – which would store clinical trial research data on emerging and neglected disease threats – so that other researchers could draw on the primary data to examine new research questions as they emerge. 

The issue, which is also the focus of a draft World Health Assembly resolution sponsored by the United Kingdom, will be the focus of a special DNDi-coordinated panel session of the Geneva Health Forum, which meets 3-5 May in Geneva for its 2022 edition. 

The session, entitled “Data-Sharing in the Time of COVID: What Works and What We Need” features Strub-Wourgaft, who is coordinating DNDi’s ANTICOV Consortium of multi-country clinical trials testing treatments in low-income settings; along with Rob Terry, of the TDR, Special Program for Research and Training in Tropical Diseases.

The session also includes Naomi Waithira, Head of Data Management, Mahidol Oxford Research Unit and Philippe Guérin, Director of the Infectious Diseases Data Observatory (IDDO), an independent platform for clinical trial data-sharing, housed at Oxford University, which is co-sponsoring the symposium. 

What is the problem? COVID outpatient studies as an example 

DNDi’s ANTICOV consortium is testing a range of outpatient COVID treatments suitable for low-income settings. But more systematic data-sharing of such clinical trial results is critical, particularly in a pandemic, in order to ensure rapid and robust recommendations, says Strub-Wourgaft.

The sad state of studies on outpatient treatments for COVID patients provides and illustration of the problem that Strub-Wourgaft aims to address, together with her other colleagues. 

“For outpatients, we’ve had thousands of studies that have looked at outpatient treatments,” said Strub-Wourgaft. “Many were underpowered” – meaning that they lacked enrollment of sufficient numbers of people to yield statistically significant results. 

Unlike hospital-based studies, which naturally have a large pool of patients to draw from, outpatient studies are often undertaken by independent working from smaller clinics, and enrolling a comparatively small sample size of patients. While such studies sometimes can provide proof of concept – they don’t usually yield the kinds of definitive results that can lead to national or global policy recommendations.

“So how do you make sense of this? We know many of the small-sized studies could not bring evidence to anything. Having a good system of data-sharing in place, however, would have helped a great deal.

She cites the big debate over the controversial treatment with ivermectin as one such example- where a plethora of small-scale studies led to conflicting results – and lots of debate – until very recently after results of a larger scale trial in Brazil were finally published. 

“It was studied all over the place, with all dose regimens” she points out, but the diversity of data only fueled the fires of controversy.  

Ivermectin – traditionally used against onchocerciasis, and a now-debunked COVID treatment.

The often bitter debate over efficacy could have been settled long ago with more conclusive evidence that the drug was not efficacious as a COVID treatment – had the smaller outpatient trials on mildly ill patients been linked up together systematically  –  with common methods, dose regimes, measurement and outcome standards at the individual patient level..  

To link disparate trials of any type of treatment,  “There needs to be analysis at individual patient level,” she points out. “This is where you get the best signals. It’s now being promoted [as an approach] but too late.” 

For instance, even the smallest discrepancies, such as the different formats that may be used for entering a patient’s date of birth – in the American style of 04-14-1990 as compared to the  European, Asian and African 14-04-1990, can befuddle attempts to rapidly compare clinical trial data from disparate studies very easily – and thus draw more robust conclusions about trial outcomes. And these delays can be deadly in a pandemic when rapid rollout of new treatments is all the more critical, Strub-Wourgaft points out.   

“Say that I want to look at the effect of age on a treatment’s efficacy,” said the DNDi scientist. “ If someone is entering the data on age with month-year, someone else with years, someone else day-month-year, how can you consolidate this.. There is a lot of work to be done so that you can pool this information.

“But for any new diseases that emerge in two years, this is something that we should be ready for.  We should have our data samples in the same format, so we can pull the data,” Strub-Wourgaft said.

Convincing researchers to share 

Clinical trial researcher examines sample.

But developing common templates for data collection for clinical trials of similar drugs or illnesses is almost the easy part of this quest by Strub-Wourgaft and like-minded colleagues.  

The even harder part will likely be convincing researchers from both academia as well as the for-profit pharma sector to share their results in a common platform – where potentially other researchers could pool data together, as well as drawing pre-existing  data results to examine new questions that emerge, such as the effects of a drug in pregnancy, or safety of a childhood dose. 

“There is a lot of work to be done so that you can pool information. It is so important, and sometimes very important signals will only come through the analysis of this pooled data… but it’s still a very relevant message,” Strub-Wourgaft says. 

“If not for ethical reasons, for scientific reasons we should share. For COVID, many people are agreeing we should have data sharing, but the devil is in the details, and those are not not in place.” 

And along with common trial protocols and templates, to really begin sharing, you need a data repository, where data can be stored – and shared under the appropriate, safe and confidential conditions sensitive patient data. 

IDDO – A platform for controlled data sharing  

IDDO, an Oxford University-hosted initiative linking the world of clinical trial data.

“Where could such a repository be?” she asks rhetorically.  “It needs to be in an independent unit. it needs to be fully equipped with the legal and technical infrastructure,” she says. 

DNDi, for its part,  found a solution in the Oxford-based IDDO, which initially had begun offering just such a repository for sharing of data on clinical trials about NTDs, but now is gradually expanding its reach to COVID treatments too.

She is hoping that DNDi’s example can inspire a broader dialogue and consensus over data sharing in a common repository – at least for NTD treatments and for any treatments that would tackle SARS-CoV2 still mutating variants, as well as other re-emerging or new, emerging pathogens that pose an outbreak threat. 

“Today, we are not asked to put anything anywhere,” she points out. But she hopes that status quo may change, under the new UK initiative in the WHA, supported by WHO, to create a common protocol for data sharing – at least in the case of publicly-funded trials. 

“In the clinical trials resolution being launched by the UK and WHO, we should say that data sharing is a must,” she declared. “The process to facilitate this should be put into place, and funding should be put into place. 

And in future research efforts supported by public institutions, researchers should agree to pool their clinical trial results as a condition of receiving their funding, she said. 

“The timing of this is sensitive, but I think there should be an agreement. Especially in the case of a pandemic, this is important. Having a sense of speed for a pandemic, it should be a kind of no-brainer.”

Addressing European data rules  

Under the IDDO platform, data is not entirely open at all.  In fact, the modalities of sharing are still carefully controlled. If one researcher wants to look at, and use, the data from the clinical trial of another research colleague or institution, then a request is filed via the platform, and the research institution that received the request can still respond with a yes or a no. 

Strub-Wourgaft stresses the importance that to be useful, such data needs to be shared at the individual patient level, what is called IPD data in the clinical trial world. 

Without precise data on a patient’s age, ethnicity, gender and other factors that can influence trial results, the kinds of more refined analyses that researchers often wish to conduct, become impossible. 

Arriving at that level of granularity in data-sharing creates other challenges, she admits, particularly with respect to new European data protection rules. 

“We are moving into a complicated situation with the European Global Data Protection Rules,” she observes. “Which provides that you will not put patients at risk, via the data that is shared.  

“There are growing concerns that we might have to  pseudo anonymise the data – because someone could still find out who a patient is, because of available data on data of birth, gender, age, place of location.

“Some push for very extreme interpretations of this.. Removing DOB altogether. But if you do that, then data sharing is really not of much use. That could make the data unusable. So the protection argument has to be nuanced. If Europe is too cautious about this, you might lose the value of the data.  

Pending WHA Resolution on Data-Sharing 

World Health Assembly Committee A in a past session: a proposed resolution to promoted sharing of harmonised clinical trial data is likely to be considered in the upcoming 75th session, May 22-28.

Strub-Wourgaft hopes that the pending WHA resolution, whose draft has not yet even been made public, might provide a framework that answers such questions. 

Should such a resolution be approved, it would also likely mandate WHO, as the world’s global health authority,  to “host” the technical data-sharing entity – whether that is IDDO or a consortium of such entities working together.

Strub-Wourgaft sees TDR, a WHO-based research entity, as the natural candidate  as the natural place to legally ‘host’ that repository.

“I would see this as being hosted by TDR, which is WHO and is doing research for WHO,” she says. 

Modalities of hosting by TDR

Robert Terry, Manager at TDR

TDR’s Terry is enthusiastic about the concept and direction: “Research funded by TDR shows that on average only 14% of registered clinical trials indicate they will be prepared to share the individual patient data (IPD) underlying a trial. 

“And there has also been no improvement in this figure when you look at pandemic diseases (including Ebola, Zika and Covid-19) despite  the various calls to share data from Wellcome Trust and partners and the WHO. 

He points to the recent TDR findings on this very topic, “Promotion of data sharing needs more than an emergency” published in the Wellcome Open Research Gateway. 

In terms of TDR’s own potential role in playing “host” to a global clinical trial data-sharing platform: 

“TDR has been involved in facilitating data sharing with the research communities it funds  for over 10 years including malaria, Schistosomiasis and other HATs.  And we have been working with IDDO to create the right governance processes for access particularly with regards to Ebola,” he adds, noting that TDR will also be publishing guidance on how to share data for its own staff and researchers in coming weeks.

In terms of the nuts-and-bolts infrastructure of such a repository, he said: 

“We felt it is better to support existing resources, particularly IDDO, rather than  to create our own [data repository] as there is a range of unique skills required to curate and provide access to data in ways that are effective, ethical and equitable. 

IDDO also is not alone in the field either, Terry adds, “There are many [other] types of platforms, including excellent resources such as the Data Compass at LSHTM. So TDR would rather establish principles of data-sharing and promote the use of these existing resources rather than fragment the sector further.

“We don’t believe the biggest barrier is infrastructure anymore.  It is a resistance to share among the research community, which needs to be addressed through better attribution of data sets (e.g. using a DOI to cite as a reference) and a change in academic assessment to recognise and reward data-sharing. 

“We are working with the Research Data Alliance, the European Union and the Global Health Network to keep getting the message across.” 

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Image Credits: DNDI/Twitter, Wellcome Trust , IDDO , WHO / Antoine Tardy, WHO/TDR.