The manifesto website calls upon other policymakers, health experts and influencers, as well as members of the general public to sign as well, ahead of the moment when political leaders will formalize the frameworks for a new Health Union.

After catching Europe unprepared, the COVID-19 pandemic has created a window of opportunity to create a “European Health Union”. And what was once a long-simmering initiative has picked up steam with a formal endorsement from the European Commission’s President Ursula von der Leyen, as well as proposals to strengthen Europe’s health security.

Ursula von der Leyen, European Commission President.

But a group of policy-minded European health experts want to ensure that the new vision of a European Health Union moves well beyond the realm of health security and pandemic response.

They are calling for a stronger commitment to climate and environmental health, health equity, preventive health – and the policies to achieve them in the context of the new European Health Union. They also want to etch a vision for the continent’s global health role, post pandemic.

The group on Tuesday issued a “Manifesto for a European Health Union” outlining their vision. The manifesto website calls upon other policymakers, health experts and influencers, as well as members of the general public to sign as well, ahead of the moment when political leaders will formalize the frameworks for a new Health Union at upcoming sessions of the European Council and the next Conference on the Future of Europe.

“This will not be the last pandemic. There will also be many other threats to health, including the effects of climate change, antimicrobial resistance, and much else. We cannot continue with life as before. We have to safeguard our societies but in ways that are proportionate to the dangers which threaten them,” the manifesto declares.

“We are happy that for once, at last, after decades, the European Union is putting health so high on the agenda,” Ilona Kickbusch, founding director and chair of the Global Health Centre, and a leading member of the Manifesto initiative, told Health Policy Watch. “But we know how volatile European policies are, and we want to show the Commission that there is broad support out there [for an EHU].”

Ilona Kickbusch, Founding Director of the Graduate Institute’s Global Health Programme in Geneva.

The manifesto sets out a vision of a European Health Union that would:

  • Strive for the health and wellbeing of all Europeans, with no one left behind
  • Strengthen solidarity within and among Member States, based on the principle of progressive universalism, providing support, including universal health coverage, for all, but with particular attention to the needs of those who are disadvantaged
  • Ensure environmental sustainability, by adopting the European Green Deal and prioritising measures to promote One Health, the concept that links our health with that of the animals and plants with which we share this planet
  • Provide security for all Europeans, protecting them from the major threats to health and from the vulnerability that is created by living a precarious existence
  • Enable everyone’s voice to be heard, so that policies that affect their health are created with them and not for them

Among the key measures proposed by the authors include the strengthening of health policies in European Treaties; expanding the EU’s involvement in health research; addressing the uneven distribution of health workers across the continent; and development of a Global Health Policy for the European Union.

Another component of the manifesto includes the creation of a Health Emergency preparedness and Response Authority (HERA) to prevent the delay and floundering seen during the COVID pandemic.

While some of the elements of the manifesto’s proposals could be adopted rapidly and without major changes to EU treaty agreements, others would likely need a stronger legal framework, Kickbusch said, noting, “probably if one is really, really serious about it, one should look at a treaty change in terms of what the European compentencies in health are.  And so we wanted to initiate a debate on the components that we saw as critical.”

The manifesto falls in line with European Commission President Dr Ursula von der Leyen’s proposal, made at her September State of the Union address, for a stronger health union in Europe and greater focus on cross-border coordination.

When work initially began on the manifesto in July, the European Parliament was considering a series of cuts to in the health budget, made by the heads of governments in the European Council.  Although the funding cuts were ultimately rejected by the Parliament, which produced a much higher budget for health, it is important to ensure, going forward, that investments are made holistically, said Kickbusch.

“It seemed important for us to ask what this actually implies,” Kickbusch said, adding that it was important that funds are not allocated solely to pandemic preparedness – “as important as that may be.”

Image Credits: European Health Union, European Parliament, European Health Forum Gastein.

Screening of passengers FOR covid-19 at Maya Maya airport, Brazzaville

Thirteen African countries and an international network of research institutions have joined forces to launch a multi-country clinical trial of COVID-19 drug treatments in Africa for people who are mild to moderately ill.

The new ANTICOV trial, led by the Geneva-based Drugs for Neglected Diseases Initiative (DNDi) aims to respond to the urgent need to identify drugs that can be used for early treatment of COVID-19.

Although Africa has so far managed the COVID-19 pandemic exceptionally well, with only an estimated 4% of the world’s cases, a resurgence of infections being seen right now underlines the fact that the continent is not immune. And what was mostly urban outbreak until now is now spreading increasingly in rural areas.

“Treating mild cases is urgently needed to halt progression to severe disease and prevent spikes in hospitalization that could overwhelm already fragile health systems,” said DNDi’s Bernard Pécoul, speaking about the launch of the new initiative. “The ANTICOV trial brings together African and global science and public health leaders from 26 institutions and will enrol up to 3,000 participants across 13 countries.”

The clinical trial will be carried out at 19 sites by the ANTICOV consortium, which includes 26 prominent African and global research and development (R&D) organizations, coordinated by DNDi, an international non-profit R&D group with extensive partnerships in Africa.

Focus on Repurposed Drugs and Combinations 

ANTICOV will initially focus on examining a series of “repurposed” drugs also used for HIV, malaria and other infectious diseases, and where evidence from a large-scale randomized clinical trial could provide missing data on the efficacy of a drug candidate in mild-to-moderate COVID patients. 

Health Policy Watch if the trial would also include cutting-edge monoclonal antibody treatments such as those recently approved by the US Food and Drug Administration, but DNDi did not comment. The organization stressed that “the goal is to include additional treatment arms in the ANTICOV trial within weeks.”

As of its launch, the trial will test the HIV antiretroviral combination lopinavir/ritonavir (LPV/r) and the antimalarial drug hydroxychloroquine – both of which have been ruled out for seriously ill patients. In the case of mildly ill patients, the jury is still out. 

Various WHO co-sponsored studies, affiliated with the RECOVERY and SOLIDARITY initiatives have concluded that both hydroxychloroquine and LPV/r therapy have no significant efficacy for severe and hospitalized cases. But the ANTICOV trial will explore if either drug might be effective in milder cases, and at different dose regimes. 

“Today, at least 16 African countries (including 7 of the 13 ANTICOV countries) are recommending the use of chloroquine or hydroxychloroquine, even though scientific evidence is lacking,” DNDi noted in a press statement. 

“Several large, randomized trials have shown a lack of efficacy of HCQ as a treatment for COVID-19 in severely ill hospitalized patients, but the drug still needs to be tested in large, randomized controlled trials with mild and moderate cases,” it added, referring to statements by WHO’s Chief Scientist Soumya Swaminathan. In June, she flagged a key gap in knowledge: “Does it have any role at all in prevention or minimizing the severity of the illness in early infection. We need to complete those large trials to have a definitive answer on that.”

As for lopinavir/ritonavir, ANTICOV is exploring a dose regimen that has not been tested in other trials in order to determine if the drug combination, normally used to treat HIV/AIDS, might be effective in the treatment of mild-to-moderate cases of COVID-19, before the inflammatory stage of the disease is reached.

Among the other potential therapeutic options being explored by ANTICOV are medicines currently used to treat malaria, HIV, hepatitis C, parasitic infections, and certain cancers. 

Adaptable Test Pad For Drug Trials 

An ‘adaptive platform’ design will enable several treatment candidates to be tested simultaneously, also allowing for the testing of new therapeutic candidates as they emerge, DNDi said.

The trial is part of the WHO cosponsored ACT Accelerator’s therapeutics arm, which was launched in April 2020 by WHO to ensure equitable global access to innovative tools for COVID-19 for all. Unitaid – one of the principal funders of ANTICOV – is a co-convenor of the Therapeutics Partnership of the Accelerator, together with the Wellcome Trust. All clinical trial data generated by ANTICOV will be shared on an open platform, DNDi said.

The trial, led and managed by African researchers, also aims to provide African-led solutions to the pandemic as well as overcome community concerns and suspicions that have sometimes emerged around the conduct of clinical trials managed by researchers from abroad.

It also makes up for a dearth of clinical trials on the continent of COVID vaccines and treatments. As Dr Borna Nyaoke, DNDI’s senior project manager in Africa told Health Policy Watch in September, among the 1,000 trials underway worldwide for COVID drugs and vaccines, fewer than 70 are taking place in Africa.

Speaking about the ANTICOV trial launch, Monique Wasunna, Director of DNDi’s Africa Regional Office, said: “African countries have proved that they have the skills and expertise to provide local solutions to this global pandemic.”

The trials are also being supported by the German Federal Ministry of Education and Research (BMBF)/KfW, as well as the European & Developing Countries Clinical Trials Partnership (EDCTP) and Starr International Foundation.

 

 

Image Credits: WHO, DNDi.

Norway’s Minister of International Development, Dag Inge Ulstein and South Africa’s Minister of Health Zweli Mkhize issue urgent appeals at WHO press briefing for $US 28 billion in funding for COVID 19 vaccines, tests and treatments.

The vaccine zero hour is approaching. As Norway’s Minister of International Development Dag Ulstein and South Africa’s Minister of Health Zweili Mkhize made yet another urgent plea Monday for some US$4.3 billion right now and another $US23.9 billion in 2021 to massively roll out new COVID19 vaccines, drugs and tests that are now coming on line, it’s increasingly clear that the funds available to support the ambitious worldwide COVAX vaccine procurement and distribution facility planned by WHO and its partners through its ACT Accelerator initiative, is, at present, woefully inadequate. 

And following the lukewarm G20 pandemic commitments at last Saturday’s Summit, which failed to include any new offers of serious vaccine finance, the upcoming holiday season could feature heavy TV coverage of the first Americans getting a freshly-approved Pfizer COVID vaccine – with Europeans, Japan, Australia and other high-income countries next in line – as the rest of the world watches the show. 

“The ACT Accelerator has compiled the world’s largest portfolio of these tools to continue rolling up rapid testing, evaluating new treatments and ensuring access to vaccines as soon as they are licensed. The accelerator urgently needs US$4.3 billion, and the further US$23.9 billion in 2021,” said Ulstein in his appeal on the WHO stage.

“I would argue that this is a no brainer for world leaders. US$23.9 billion sounds a lot, yet the total needed is less than one-tenth, or one percentage point of global GDP. In other words, if G20 countries were to devote just 1% of the current stimulus spending on efforts to alleviate the economic consequences of the pandemic,” he said, “they would actually more than cover the needs of the next generation. I would argue that this is a small price to pay to getting the world back on track.” 

It may be a small price, but there is also much more at stake. Any deadlocked funding also threatens to pit two long standing world views against each other – in much more direct competition than what has been seen in decades.

One, led by the G20 economies, is hugely invested in their pharma industries, and a donor-driven regime of massive vaccine purchases at reduced prices, and distribution for poorer countries. They argue that the private sector confidence that they will reap as a reward for their efforts is necessary to incentivize the expensive investments required for any vaccine R&D, let alone the COVID research effort that has taken place at unprecedented scale and speed. 

R&D at AstraZeneca with robotics-supported technologies

Another vision, led by South Africa and India, is challenging that more fundamentally. They are pressing ahead for an IP “waiver” in the World Trade Organization (WTO) – so that countries would have the discretion to waive, for the period of the pandemic, not only COVID-related patents, but also trade secrets, industrial designs and copyrights associated with prized vaccines, tests or treatment technologies.

This, South Africa, India and its partners say, would greatly expand countries’ own ability to produce, as well as to export and import desperately needed vaccines, tests, and treatments quickly, and at much reduced prices – while bolstering the greater self-sufficiency that has become so important in the pandemic.

“We find that COVAX is a good start, but it’s not the solution,” said a leading South African diplomat, speaking with Health Policy Watch. “We are happy to work with multilateral approaches, of which COVAX is an example, and we are also able to work with voluntary licenses given by countries like AstraZeneca. Every little bit helps.

“But these approaches do not result in ramping up the production capacity, if they are limited to only a handful of producers. There’s no guarantee in terms of the volumes being supplied, within the timelines that are required to establish effective access. And even if we had volumes procured through COVAX that would cover 20% of the population for low- and middle-income countries (LMICs) … then you still don’t reach herd immunity.”

South Africa & Norway – Seeking a Way Forward

To be sure, as evidenced by the joint appearance of Ulstein and Mkhize today at the WHO press conference, both sides are trying to find new modus vivendi for bridging the stark differences between rich and poor countries in the global North and South, and create a practical way forward for sharing the benefits of new technologies more broadly – during a pandemic. 

Ulstein said: “We have a wide portfolio of candidates on the cusp of finalizing Phase 3 trials; we need to make sure that we do not end up with having these tools, but not the infrastructure to make them available at all.” 

Mkhize added: “Global solidarity isn’t just the right thing to do, it’s the smartest thing to do, ensuring that tools are allocated equitably, and not just based on income, but based on universal protection against COVID-19. It is the fastest and most effective way to defeat the pandemic and get our lives and our economies back to normal again.

“The lack of adequate financing for the ACT Accelerator is an existential threat to the economic and health security of all countries and their citizens.”

Whether due to its youthful population, strict preventive measures, or prior experience with dangerous outbreaks and epidemics, African countries have largely succeded in restraining the spread of the pandemic – in a success story that other regions have sometimes envied – but this has also come at a huge economic and social costs. 

Up until now, the entire continent has recorded just 2 million cases and 14,000 deaths – just 2.5% of the global caseload – and a fraction of the 12 million cases and 250,000 deaths see in just one country, the United States, which leads the world in terms of its COVID-19 infections, pointed out Mkhize. 

However, Africa is not immune either, he added, noting a resurgence of the virus underway just now, with a more than 20% increase in cases just over the past week. “The resurgence on the African continent will evolve, and therefore early equal access to vaccines and therapeutics will be critical to mitigating the threat posed,” he said. 

“We must treat access to COVID-19 tools as a global public health initiative: collective efforts to stamp out the virus now would also mean that future virus strains or mutations, that are more difficult to treat, could be avoided. It is clear that every country will need to play a part in financing an end to this crisis, and every leader has a political choice to make.” 

AstraZeneca Vaccine Results Accelerate Access Debate
Vaccine deals by country and for the COVAX pool as of mid-October – by Suerie Moon, Co-Director at Global Health Centre, Geneva Graduate Institute

For LMICs, the promising Phase 3 trial results of 24,000 volunteers, announced by AstraZeneca and its research partner Oxford on Monday – which saw 90% protection from the virus in one stream of dosing strategies, are a beginning, in terms of the concrete possibilities to deliver vaccines that can be handled through the normal supply chains.

WHO’s Chief Scientist Soumya Swaminathan, speaking at the WHO press conference, said the AstraZeneca results are particularly important due to their modest cold chain requirements – refrigerator storage at 2-8 C is sufficient. “This has, of course, huge logistical advantages for transporting and delivering this vaccine to cities and towns and villages and rural areas around the world,” she added.

Soumya Swaminathan, WHO Chief Scientist

Unlike the Moderna and Pfizer vaccines, AstraZeneca’s candidate also is based upon a tried and tested “viral vector strategy” she noted. That means that it uses a weakened form of another virus (a common adenovirus) to deliver the genetic code for a protein that is part of the characteristic a SARS-COV-2 spike – prompting a person’s body to mount an immune reaction. But it also means that the vaccine was developed and can be produced at a much lower cost than counterparts by Moderna and Pfizer that rely upon newly developed mRNA technologies.

Manufacturers like India’s Serum Institute, which have already acquired a license from AstraZeneca to produce its vaccine, have said that they will be able to produce and sell it for as little as US$ 3 a dose (it requires two shots), as compared to a cost of US$25-30 for the Moderna and Pfizer alternatives, which rely upon newer mRNA technology.

The low-cost is also due to the fact that AstraZeneca’s licensing agreements with manufacturers in India, Brazil and elsewhere are on ‘no-profits’ basis until the pandemic is over. Althought that pledge may have its limits in the light of revelations that the company reserved the right to declare an “end” to the pandemic as early as July 2021, according to one agreement made with Brazil’s Fiocruz Institute.

But while AstraZeneca’s deals with the Serum Institute and other similar partners could allow for the production of some 2 billion vaccine doses or more in the coming year, at two doses a person, expected global demand will still be 7-8 times that. 

 

Vaccine pre-orders by COVAX and countries to pharma firm as of mid-October; Suerie Moon, Co-Director at Global Health Centre, Geneva Graduate Institute

And the AstraZeneca commitments only channel about 300 million doses to COVAX, while the lion’s share would still go directly to the countries hosting production, like India and Brazil, as well as middle or high-income countries such as the United Kingdom, the European Commission (400 million doses), and others. Like counterpart vaccines produced by Moderna and Pfizer, middle and high income countries have pre-orders or options to purchase a sizeable chunk of the doses likely to be available next year from manufacturers – not including vaccine candidates being developed by China and Russia, which may open up other alternatives.

As Swaminathan noted, still more vaccines will be needed: “Remember we have to cover a huge number of people, billions and billions of people this is unprecedented. And we will need all the manufacturing capacity in the world, to be able to do that”. 

India’s Serum Institute – India First Strategy & A few Hundred Million Doses for COVAX By July

Speaking at a live “Leadership Summit” last week in India sponsored by the Hindustan Times, Adar Poonawala, head of India’s Serum Institute stressed that the first cut of the Serum Institute vaccines would also go to India and Bangladesh, as part of the company’s national and regional commitments.

The Serum Institute would be positioned to having “a few hundred million” vaccine doses to offer to COVAX by July or August of 2021, he said.

And those commitments already represent the upper limits of production capacity, he added, cautioning, that “we don’t want to partner with anyone [more] right now … We will be committing to more than what we can handle”.

Along with the logistical barriers of production, there remains the barrier of cost – or conversely that of finance – for other vaccine options. 

Poonawala said: “Indian vaccine prices will always be probably half or less than what we are seeing in the West with US$20 and US$30 dollar pricing that Pfizer and Moderna have publicly announced. Ultimately, I don’t know if they will come down on price. They might with public pressure, global pressure which is there.

“If we are talking about a US$10-US$20 dollar vaccine, you will need a budget of US$60-US$70-US$100 billion dollars, which the world doesn’t have for vaccinating everyone.

“Initially there might not be a choice for governments but to just pay these high prices. But eventually, when there is enough supply and alternatives you will see prices coming down drastically.

“Because the world will soon realise that there are other options coming from India and China at more affordable prices.” 

 

With reporting by Kerry Cullinan in Cape Town and Menaka Rao in Delhi, India.

 

Image Credits: AstraZeneca , R Santos/HP Watch, WHO.

AstraZeneca vaccine in development
The AstraZeneca vaccine would be offered at prices beginning at around US$3 per dose, compared to US$20-25 for Moderna and Pfizer’s cutting edge mRNA technology options.

AstraZeneca, the pharma firm developing a COVID-19 vaccine in collaboration with researchers at Oxford University, announced that its Phase 3 clinical trials had resulted in a 90% efficacy rate for one dosing regime, in interim results released on Monday.

The AstraZeneca breakthrough is significant because the vaccine, based on a known vaccine delivery technology, is the least expensive option among the front-running vaccine candidates, and would be offered for sale at prices beginning at around US$3 per dose, as compared to US$20-25 for Moderna and Pfizer’s cutting edge mRNA technology options.

Access advocates worry that AstraZeneca’s “no-profits” pledge could be of too short a duration, lasting only until July 2021.

Those features, along with the establishment of vaccine manufacturing centres in India, Brazil and elsewhere, open up the potential for widespread production, use and distribution in low- and middle-income countries (LMICs), the company said.

“This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency,” said Pascal Soriot, AstraZeneca CEO. He added: “The vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval.”

At the same time, the WHO co-sponsored global COVAX procurement pool that aims to supply most of the world’s population with new COVID vaccines has said it needs close to US$1 billion urgently – and another 6.8 billion in 2021 to even begin to fill needs in LMICs that haven’t already pre-ordered huge vaccine stocks. Including treatments and tests, some US$4.5 billion is needed urgently and US$28 billion over the coming year, WHO has said.

And while the G20 meeting on Friday yielded a high-minded statement that the group, consisting of the most industrialized countries, would “spare no effort” to overcome the pandemic, it was not matched by new and more concrete funding commitments to new vaccines and treatments.

Access advocates also worry that AstraZeneca’s “no-profits” pledge could be of too short a duration – lasting only until July 2021, according to some reports – falling short of the mark of a “people’s vaccine” that some say is needed.

So far, none of the positive clinical trial results announced by AstraZeneca, Moderna and Pfizer over the past several weeks have been subject to peer review – although Pfizer’s application for emergency use authorization was submitted to the US FDA on Friday and could be approved as early as 10 December, with Moderna’s to follow very soon.

AstraZeneca said it plans to submit the interim efficacy and safety data to regulators in the United Kingdom, Brazil and with the European Medicines Agency shortly for independent evaluation and emergency use approval. In addition, the data will be submitted for peer review and publication, the company said.

AstraZeneca Results – Initial Half Dose Gets the Best Results

In terms of the AstraZeneca vaccine, the unblinded interim results from the Phase 3 clinical trial in the United Kingdom and Brazil saw some 131 COVID-19 cases out of the 23,000 participants in AstraZeneca trials globally, who were trialled on two different dosing regimes.

The dosing regime with the highest 90% efficacy rate involved administration of a half-dose first to participants, followed by a full dose a month later. The other regime, involving two full doses was only 62% effective, according to the results by an independent Data and Safety Monitoring Board.

60,000 total participants are expected to be enrolled by the end of 2020 in further trials in the United States, Japan, Kenya, and India.

Protection from COVID-19 was present 14 or more days after receiving both doses of the vaccine. The results support earlier evidence that the vaccine candidate induces a strong antibody immune response across all age groups.

Some 60,000 total participants are expected to be enrolled by the end of 2020 in further trials in the United States, Japan, Kenya, and India.

AstraZeneca’s Phase 3 trials were paused in the first week of September after the discovery and investigation of an undisclosed illness. They resumed in the UK a week later, but only in the US on 23 October, nearly 7 weeks later, after the US FDA gave its approval.

AstraZeneca’s adenovirus vaccine, which uses technology that has been widely utilized for decades, is easily manufactured, transported, and stored in domestic fridge temperatures (2-8°C) for at least six months. This allows for global administration of the vaccine using existing medical facilities.

This is in comparison to the two other leading vaccine candidates. Moderna’s mRNA vaccine had a 94.5% efficacy rate and can be stored at 2-8°C for up to 30 days, requiring long term storage at -20°C. Pfizer’s mRNA vaccine reported a 95% efficacy rate and long term storage temperatures below -70°C, which requires ultra-cold storage facilities.

AstraZeneca predicts that it can produce 3 billion doses of the vaccine in 2021.

“The announcement today takes us another step closer to the time when we can use vaccines to bring an end to the devastation caused by SARS-CoV-2,” said Sarah Gilbert, Professor of Vaccinology at the University of Oxford. “We will continue to work to provide the detailed information to regulators.”

Pfizer Applied For Emergency Use Authorization From The FDA

On Friday, Pfizer submitted an emergency use authorization (EUA) for its COVID-19 vaccine candidate, developed in partnership with BioNTech, to the US FDA, and plans to apply immediately to other regulatory agencies globally.

Pfizer estimates the use of the vaccine in high risk populations in the US by mid to late December, pending FDA approval.

The news of Pfizer’s move to pursue an EUA came two days after its announcement of the conclusion of its Phase 3 clinical trial and the preliminary efficacy results of 95%. Protection against COVID-19 was found beginning 28 days after the first dose.

If approved by the FDA, Pfizer estimates the use of the vaccine in high risk populations in the US by mid to late December.

“Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Albert Bourla, Pfizer CEO, in a press release.

The FDA scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on 10 December to evaluate the trial results and consider granting an EUA.

“The FDA will review the [EUA] request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible,” said FDA Commissioner Stephen Hahn in a FDA news release.

The FDA emphasized their desire to conduct the review of EUAs in a transparent manner, releasing the meeting agenda and committee roster two days before the meeting.

Said Hahn: “The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines.”

While Pfizer and BioNTech wait for potential authorization, they prepare to scale-up the manufacturing and distribution of the vaccine candidate. They estimate their capacity to supply up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

Meanwhile in a breakthrough on the treatment front, the FDA authorized for emergency use the experimental Regeneron antibody cocktail, which gained fame when it was administered to President Donald Trump when he became ill last month. Regeneron’s treatment of two antibodies, casirivimab and imdevimab, was authorized for use among people at risk of developing severe COVID-19, but not yet seriously ill. It could even cause adverse effects in more serious cases, the FDA warned (see related story).

Image Credits: AstraZeneca, National Institutes of Health (NIH) , National Institutes of Health (NIH) , Pfizer.

Scientist developing antibody medicines in Regeneron’s lab.

The US Food and Drug Administration (FDA) authorised an experimental antibody cocktail produced by Regeneron for emergency use on Saturday. The treatment, consisting of the two antibodies casirivimab and imdevimab, will be limited to patients aged 12 and over with positive SARS-CoV2 test results and at risk of developing severe COVID-19. 

Clinical trial results showed that the cocktail reduced hospitalisations and emergency room visits within 28 days after treatment. The greatest benefit is achieved early in the course of the disease. The FDA warned of the potential for negative clinical outcomes when administered to hospitalised patients requiring oxygen or mechanical ventilation. 

“Authorising these monoclonal antibody therapies may help outpatients avoid hospitalisation and alleviate the burden on our health care system,” said Stephen Hahn, FDA Commissioner. 

The antibody cocktail gained publicity after it was given to President Trump when he was diagnosed with COVID-19 in early October. The two antibody components function by targeting the spike protein of SARS-CoV2, blocking the attachment and entry of the virus into human cells. 

“The casirivimab and imdevimab antibody cocktail is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralise the virus,” said George Yancopoulos, CEO of Regeneron, in a press release. 

Regeneron has said it expects to have enough doses for 80,000 patients by the end of November and 300,000 patients by the end of January 2021. The biotech company signed a supply agreement with Operation Warp Speed – a US government program to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics, and diagnostics – for the 300,000 treatment doses. 

The evaluation of the safety and efficacy of the treatment cocktail will continue in Phase 2 and 3 clinical trials. FDA approval may follow a rigorous evaluation of the scientific evidence from the clinical research and safety monitoring. 

Debate Over Access to New Monoclonal Antibody Treatments Heating Up

So far Regeneron has the capacity to produce about 300,000 doses of its antibodies casirivimab and imdevimab, most of which will go into the US market. Meanwhile, however, low- and middle income countries are anxiously eyeing these new developments to see how they might access cutting-edge technologies.

WHO’s Act Accelerator initiative has set into place the procurement framework to purchase  monoclonal antibodies through its therapeutics arm, if those are approved. But so far it’s not clear who would produce these for the wider global market. Nor is it clear if Regeneron and others will issue licenses for their products to others – or if a standoff over access may wind up in the ballpark of the World Trade Organization, which is discussing an “IP waiver” on needed health products for the duration of the pandemic.

Image Credits: Regeneron.

Mia Amor Mottley, Prime Minister of Barbados.

In a bid to step up a battle against other emerging and untreatable pathogens that could wreak havoc on the world in ways similar to COVID-19, WHO on Friday announced the launch of a One Health Global Leaders Group on Antimicrobial Resistance (AMR).

The group, led by the prime ministers of Bangladesh and Barbados, aims to raise the political profile of the threat posed by drug-resistant bacteria, viruses and other microbes – and get politicians to act more firmly to ration and control the use of life-saving drugs that are slowly losing their potency due to rampant overuse in both human health and agriculture. 

But the new initiative co founded by the WHO, Food and Agriculture Organization of the UN (FAO), and the World Organization for Animal Health (OIE) stops short of setting a clear roadmap for making recommendations to governments about the kinds of tough new regulatory measures that some advocates say would be needed to stem the threat of AMR. 

Asked about the possibility that the FAO or OIE might consider recommending the mandatory labeling of animal products with details of antibiotics used in their production, OIE’s Deputy Director General, Matthew Stone, ducked the question, saying that at present the agencies are just trying to get country to track drug use in animals more systematically.  

Matthew Stone, Deputy Director-General, International Standards and Science,World Organisation for Animal Health (OIE).

“We’re now in our fifth year of data collection to work with our member countries to understand their usage patterns of antimicrobials in animals, across terrestrial animals and aquatic animals, to understand what molecules they’re using and what diseases they’re treating in terms of those molecules,” said Stone. “And this accounting mechanism ….is allowing countries to track their own usage and hopefully drive that usage down, towards prudent and responsible use.”  

WHO’s Global Action Plan to Combat AMR, which dates to 2015, also provides no concrete guidance about health or food safety policies to restrict over-the-counter antibiotic sales or label foodstuffs in which antibiotics were used; it merely recommends that countries develop national action plans to combat AMR.  

Along with labeling the use of antibiotics on food products, studies have suggested that other effective mandatory measures to combat AMR in both humans and animals could include: banning the sale of over-the-counter antibiotics in low- and middle income countries, where the use of non-prescription antimicrobials is often very high, and establishing national standard treatment guidelines to prevent clinical misuse of antimicrobials. 

AMR Trust Fund Announced Alongside Global Leaders Group 

The Global Leaders Group was launched at a WHO press conference on Friday, during the World Antimicrobial Awareness Week. 

Antimicrobial resistance (AMR) – which occurs when bacteria, fungi, viruses, and parasites develop resistance to common drugs  – threatens to undermine a “century of medical progress” and poses a serious risk to human, animal and environmental health, food security, and economic development, said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in announcing the new policy leadership group. 

Sheikh Hasina Wazed, Prime Minister of Bangladesh.

“There is no doubt that antimicrobial resistance has become a global public health challenge both for humans and animals. We are running out of available antibiotics and soon we will face another world health emergency more severe than the current COVID-19 pandemic,”  said Bangladesh’s Prime Minister Sheikh Hasina Wazed, who will co-chair the group. 

“The systematic misuse and overuse of these drugs [antibiotics, antifungals, antivirals, and antimalarials] in human medicine and food production have contributed to this raising antimicrobial resistance or the ability of a microorganism to stop an antimicrobial from working against it,” said Mia Mottley, Prime Minister of Barbados and the other co-chair. 

The group is comprised of 20 members drawn from government, the private sector, research and civil society, with most being ministers, deputies or former ministers of agriculture, health, and environment. These include representatives from: Australia,  Bhutan, Iraq, Japan, Portugal, the Russian Federation, Nigeria, Saudi Arabia, Senegal, Singapore, and Sweden. The group also includes the UK’s Special Envoy on Antimicrobial Resistance, Dame Sally Davies, and Wellcome Trust Director General, Sir Jeremy Farrar, as well as Lothar Wieler, President of Germany’s Robert Koch Institute, and Brazil’s senior agriculture attaché to the European Union. From civil society, there is Sunita Narain, the prominent director-general of India’s Centre for Science and Environment, and from the private sector, Kenneth Frazier, CEO of the pharma giant Merck & Co. 

Launch of the group coincided with the announcement of $US 13 million in donations from The Netherlands, Sweden and the United Kingdom to a new trust fund to foster AMR action at country level, said WHO’s Director General Tedros Adhanom Ghebreyesus at the press conference.  An initial pilot will take place in Indonesia.  

Hanan Balkhy, WHO Assistant Director-General of Antimicrobial Resistance.

The misuse of antimicrobials is being exacerbated by COVID-19, said Hanan Balkhy, WHO Assistant Director General on Antimicrobial Resistance. She cited one study that reported some 70% of patients hospitalized had received antibiotics, even though only 15% developed, or were at risk of developing, secondary bacterial infections.

She acknowledged that there have also been worrisome reports of new forms of pathogen resistance to detergents and other disinfectant products that are being used much more abundantly in health care facilities since the pandemic erupted, and said that it pointed to the need for good hospital hygiene and sanitation measures alongside disinfectant use. 

“Good News” That Recovered Covid Patients Sustain Immunity Levels 

In other developments, WHO officials said that a recent study indicating that COVID-19 immunity might persist for as long as six months after infection is “good news”.  The results of the study, while small, could also bode well for the prospects of upcoming vaccines conferring immunity for similar periods of time, said WHO Health Emergencies Executive Director Mike Ryan.    

The study published on the science server bioRxiv.org, prior to peer review, found that of the 185 patients examined, 90% had neutralizing antibodies present 6-8 months after their infection. Neutralizing antibodies are associated with protective immunity against a secondary SARS-COV-2 viral infection. 

Mike Ryan, WHO Executive Director of Health Emergencies Programme.

“This is really good news to see that we’re seeing sustained levels of immune responses in humans so far,” said Ryan, “This is potentially significant news that extends the period for which we know there is likely protection and hopefully that period will extend further and further. 

“It also gives us hope as well on the vaccine side that if we start to see similar immune responses to the vaccine, we may hope for longer periods of protection,” Ryan said.

More long-term research will be needed to determine the precise length of COVID-19, but hundreds of studies on the topic are currently underway in  over 50 countries on the topic, said Maria Van Kerkhove, WHO Technical Lead on COVID-19. 

Said Van Kerkhove: “We still need to follow these individuals for a longer period of time so we can determine how long these antibodies last. But this is good news.”

Image Credits: WHO.

COVID-19  has, moreover, spurred increased use of antibiotics – ostensibly to suppress or prevent secondary bacterial infections that people sick with the virus could also get.

This week is World Antimicrobial Awareness Week, marking the fight against the silent and rising global threat of antimicrobial-resistant superbugs. Can patients be part of the solution?

This week is the World Antimicrobial Awareness Week (WAAW) when we turn the world’s attention to the growing problem of drug resistant diseases – caused by bacteria, viruses and other pathogens that have developed resistance to the lifesaving drugs that we use every day.

Why Is This Important?

Antimicrobial resistance (AMR) is a natural process of pathogens’ adaptation to the drugs we use to kill them, which should normally have a slow evolution-like pace. Our inappropriate use of common antibiotics, antiviral agents and other drugs on all fronts of human and animal health speedwarps this process.

The often imperceptible tidal wave of AMR already kills some 700,000 people each year. But it threatens to become a “tsunami”, as World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus recently said. A report last year by a special ad hoc UN group, “No Time To Wait” projected that the world could see up to 10 million deaths annually by 2050. This looming crisis thus has the potential to be as large or even larger than COVID-19 in terms of the death toll and economic costs.

The Problem is Not New

Alarm bells started ringing as early as 2008, when the European Centre for Disease Prevention and Control issued warnings about the trends. In 2015, WHO adopted its first Global Action plan on AMR – and the world observed the first Antimicrobial Awareness Week.

However, so far the warnings have failed to turn around embedded practices and habits. Although awareness in some health systems is growing, there is widespread overuse of antibiotics and other antimicrobial agents in countries with weak regulatory systems – where people can buy antibiotics and other drugs over the counter without a prescription.

In addition, drugs that need to be reserved for human use are still wantonly used in industrial livestock production as growth promoters or disease prevention –  further increasing risks that drug-resistant bacteria will emerge. In many countries it is difficult or impossible to even assess how much antibiotics and other antimicrobials are used, where, and on what populations.

COVID-19  has, moreover, spurred increased use of antibiotics – ostensibly to suppress or prevent secondary bacterial infections that people sick with the virus could also get. And this, according to WHO, is exacerbating AMR trends. In the United States, some 70-80% of hospitalised COVID-19 patients received antibiotic treatment, according to one report, even though less than 10% actually had secondary bacterial infections.

Pandemic as an Opportunity: the World is Waking Up

Against this grim reality, however, the current pandemic may also be serving as something of a wake-up call fostering more action on AMR, among both health care providers – as well as the patients that my organization, the International Alliance of Patients’ Organizations (IAPO), represents. Having confronted the harsh reality of a deadly virus for which there is no vaccine, medicine or treatment – can we act more assertively to stave off future threats like this that could emerge if more bacteria and viruses become resistant to the existing drugs that we do have?

This July, an AMR Action Fund of nearly $1bn was established by more than 20 leading biopharmaceutical companies, with a mission to bring 2-4 new antibiotics to patients by 2030, and replenish the collapsing antibiotic R&D pipeline. This fund complements other initiatives, like the WHO’s Global Antibiotic Research and Development Partnership, and its added value is in creating market conditions that enable sustainable investment in the antibiotic pipeline.

In August, the Tripartite Coalition of the WHO, the Food and Agriculture Organization (FAO) and the World Organization for Animal Health (OIE) initiated a “One Health” Global Leaders Group on Antimicrobial Resistance, to advocate for urgent action among heads of state, government ministers, private sector and civil society. The  Group, co-chaired by the prime ministers of Bangladesh and of Barbados, will be formally launched at a WHO press conference on Friday.

On Wednesday, Wellcome Trust launched their report “The Global response to AMR: Momentum, successes and critical gaps”, underlining that AMR is not only reversing recent progress in controlling infectious diseases, but is also undermining improvements in healthcare provision in general, threatening to disproportionately more affect the low- and middle-income countries.

This AMR week will also see a flurry of activities across WHO regions, under the theme “Unite to prevent antimicrobial resistance”. And in the spirit of “One Health, stakeholders across diverse sectors are linking together on this common interest.

This is reflected in a joint call for more action issued Wednesday by IAPO along with the International Hospital Federation, the International Society for Quality in Health Care, and the International Federation of Pharmaceutical Manufacturers and Associations.

The statement calls for the development of more innovative partnerships of healthcare providers, patients and the business sector to tackle the growing AMR threat while improving healthcare safety and quality worldwide.  It aims to raise awareness of AMR, promote antibiotic stewardship and call upon policymakers to create the appropriate conditions to attract investments in R&D to ensure that a sufficient pipeline of antibiotics will remain available to treat both common and rare infections.

Empowering Patients to Fight AMR in A Global AMR Patient Alliance

Paternalistic approaches to healthcare have largely left patients on the sidelines in the battle against AMR. This, despite the abundant evidence showing that patients bear a big part of the responsibility for what is happening right now.

Driven by Einstein’s postulate that we cannot do the same thing, and expect a different result, IAPO along with patient organisations from different regions and countries has developed A Global Patient Consensus Statement and a Call to Action, that aims to convene civil society groups representing patients, carers and advocates in a global AMR Patient Alliance, to be launched in the first week of December. The AMR Patient Alliance will be a place where patients can exchange views, be educated, and acquire knowledge and resources that we need to raise awareness about the importance of sustaining the efficacy of antibiotics – for as long as possible, for as many patients as possible.

Among patients today, there are widespread practices of self-treatment with antibiotics. Patients also put pressures on providers to prescribe such medications – even when their health care provider may not think they are needed. And, there remains a widespread public perception of antibiotics as ‘a wonder drug’; evidence shows that if patients can get access to antibiotics without a prescription, they will do so. Oftentimes, patients may only follow a partial antibiotic course or use antibiotic leftovers inappropriately – if no direct harm is perceived.  But these behaviours also stimulate drug resistance. All of this needs to change.

It is always politically sensitive to mention that patients have some responsibility. But, no amounts of funding to develop new drugs or curb AMR now will work, if people at the grassroots continue to abuse their life-saving potential. The magnitude of people’s power is so great…and it can be destructive or productive.

That is why, at IAPO we have joined the AMR fight in order to convert this challenge into an opportunity, by building awareness and empowering patients to take responsibility – so as to preserve their right to use antibiotics and antimicrobials over the long term.

We All Have a Role to Play

The problem of antibiotic overuse or misuse is not restricted to certain countries or regions, although the drivers may vary by country.  According to Professor Hanan Balkhy, assistant director general for antimicrobial resistance at the WHO, categories of antibiotics that are only used very selectively when all else has failed, on hospitalized patients in intensive care – can often be obtained by outpatients or over-the-counter in low- and middle-income countries.

And even when drugs to people are being rationed more carefully, an out-sized footprint for antibiotic use in livestock exists in countries ranging from the USA to Spain, Italy and Chile. This exacerbates risks that these drugs may one day soon, become ineffective in human populations.

Finally, only about one third of all countries are actually tracking their antibiotic use systematically, according to WHO, with significant discrepancy across regions – from 85% of European countries to none in South East Asia. In some countries, notably  the USA, animal use is systematically reported at the national level – but not so for human use.

The problem is not a simple one – solutions are complex and interrelated. We knew that progress would be slow and the current pandemic has set up new challenges. The ‘infodemic” of fake news and unconfirmed facts has also seen conflicting messages about the effectiveness of antibiotics on viruses – undermining one of the key principles of rational and appropriate antibiotic use.

Appropriate antibiotic use is everybody’s business – not only of governments and healthcare providers, but of patients and industry as well. The old ones we have to preserve, as the new antibiotics discovery pipeline has run dry in the past decade. Our generations have enjoyed the 20th century discovery of antibiotics; yet, we need to treat them not as an inheritance from the past, but as borrowed from the future generations. If we want to live in and leave a better, safer world.

Image Credits: NIAID.

Vials of remdesivir
The study published in The BMJ found that remdesivir had no meaningful effect on mortality or other significant outcomes, like the need for mechanical ventilation.

WHO on Friday issued formal guidelines recommending against the use of remdesivir for COVID-19 patients, based on a  lack of evidence that the antiviral drug, developed by Gilead, significantly improves patient outcomes.

The recommendation followed publication of trial results on the drug in the The BMJ  involving more than 7,000 patients who had been hospitalized with COVID-19.

Reviewing data obtained from 4 international randomised-controlled  trials, the WHO Guideline Development Group (GDG) concluded that remdesivir had no meaningful effect on mortality or other significant outcomes, like the need for mechanical ventilation.

Four patients who have had COVID-19 were among the panel of leading experts to review the data.

WHO previously advised against the use of remdesivir in October, based on insufficient evidence of its benefits.

WHO did clarify, however, that further evidence would be needed to write-off the treatment completely, and encouraged continued enrolment into ongoing remdesivir trials, to provide higher certainty of evidence for specific groups of patients.

The authors of the paper wrote: “Considering the low or very low certainty of evidence for all outcomes, the panel interpreted the evidence as not proving that remdesivir is ineffective; rather, there is no evidence based on currently available data.”

The authors also said: “The unprecedented volume of planned and on-going studies for COVID-19 interventions … implies that more reliable and relevant evidence will emerge to inform policy and practice.”

“The solidarity results are available in preprint and those are publicly available. And that provided some of the largest evidence source for the guideline that we publish and the recommendation we made today that is currently under peer review in a journal and from what I know, will be available shortly,” said Janet Diaz, WHO Head of Clinical Care in Health Emergencies, in a WHO press conference Friday just after the negative WHO recommendation was announced.

Due to the negative results, WHO’s plans to “pre-qualify” remdesivir for bulk procurement and sale to developing countries have also been put on hold, said WHO’s Mariangela Simao, who oversees the prequalification process.

Gilead Sciences Ignored WHO Evidence In US FDA Submission For Drug’s Approval

The formal recommendation against remdesivir’s use followed upon statements made in October by WHO’s chief scientist to the effect that WHO’s evidence, drawn from WHO co-sponsored “Solidarity” trials of the drug, had not shown significant benefits for the drug.

The WHO Chief Scientist, Soumya Swaminathan, spoke just after the United States Food and Drug Administration had approved the drug, in a review that failed to consider the results of WHO trial findings.

At the time, Swaminathan, noted that Gilead had not included the WHO data that had provided to them in their FDA submission for drug approval. Speaking at a press conference, Swaminathan said that results had been provided for its Solidarity Trial weeks before the submission, “but it appears that the Solidarity results were not considered, were not provided to the FDA”.

She also said: “What we understand from the FDA decision yesterday was that it was based on data submitted to them from Gilead, which did not include the Solidarity Trial results.”

In a press conference on Friday, Swaminathan said that despite the negative recommendation for remdesivir, to date, the results released are still interim. And the remdesivir arm of the Solidarity Trial would continue until the sample size that had been planned originally is reached.

“The results of the solidarity trial that were released on October 15th were interim results. So the trial is continuing with the Remdesivir arm until the sample size is reached,” said Swaminathan. “We had an agreement with Gilead for a certain number of doses, and we will continue to enroll until we complete that.”

Once the trial is completed, she said that the data base would also be shared with Gilead, Swaminathan added.  But already,  a peer reviewed publication on the findings so far will be published.  Said Swaminathan: “What will be available very soon is the peer reviewed publication that should be out in the next couple of days. But it’s almost the same as what had been released in the pre-print. So most of the data is already out there.”

Image Credits: Gilead, Gilead.

Tobacco protests
The tobacco industry is responsible for more than 8 million deaths annually worldwide, but has now framed itself as being “part of the solution” to the COVID-19 pandemic.

The tobacco industry has been exploiting the COVID-19 pandemic and resulting health sector resource shortages to gain a stronger foothold in the policy corridors of many national governments – making huge donations of PPE and other desperately needed goods, new research has shown.

The Global Tobacco Industry Interference Index 2020, released by STOP (Stopping Tobacco Organizations and Products) on Tuesday, a global tobacco industry watchdog, scores some 57 countries around the world for their policy performance vis a vis the tobacco industry.

Key findings reveal that the tobacco industry used endorsement of charitable contributions to capitalize on the vulnerability of governments facing a shortage of resources during the COVID-19 pandemic, including donations of free PPE in Bangladesh, artificial respirators in Costa Rica, sanitizer in Kenya and Indonesia.

But those donations often came at a price – for instance in Indonesia the company also asked the local government of Bali to roll back restrictions on outdoor tobacco advertising.

All in all, the report found that the worst performing countries were: Japan, Indonesia, and Zambia, with  high levels of industry interference in government policies. The South-East Asian country of Brunei Darussalam, as well as France, and Uganda ranked the best.

Japan, Indonesia, and Zambia rank worst overall due to deep ties between the government and the tobacco industry.

“The coronavirus pandemic has given the industry an opportunity to knock on doors and offer immediate donations in exchange for favors down the road. Ultimately, citizens pay a price for their governments accepting tobacco industry donations: more harm, death and disease from tobacco products,” said Jorge Alday, director at the New York City-based global health non-profit Vital Strategies, and a partner in STOP, an initiative supported by Bloomberg Philanthropies.

 Big Tobacco Working To Hook New Users In Pandemic Times

The new index covers countries in Africa, the Eastern Mediterranean region, Latin and North America, Europe, South and Southeast Asia, and the Western Pacific region. This is compared to just 33 countries reviewed in the first index, published in 2019.

Countries were ranked on a scale of 0 to 100, with a lower score indicating a lower overall level of interference from the tobacco industry. The Index found that lack of transparency in interactions with the tobacco industry, government endorsement of tobacco-related charity, industry targeting of non-health sectors to derail tobacco control measures and conflict of interests are the main problems globally.

“Even as more countries adopt comprehensive tobacco control, the tobacco industry is working to undermine government efforts in order to hook new users and push new products,” says Kelly Henning, director of public health programs at Bloomberg Philanthropies. “They have even gone so far as to try and take advantage of the COVID-19 pandemic, when countries are desperate for resources.”

Brunei Darussalam, France, and Uganda ranked best. The 2019 report’s best-ranked country, the United Kingdom, slipped to fourth place as a result of connections between industry and current government ministers and industry participation in government consultations in 2019.

Though the tobacco industry is responsible for more than 8 million deaths annually worldwide, it has never taken responsibility for the disease and deaths its products cause, and has even framed itself as being “part of the solution” to the COVID-19 pandemic, the report states.

Although Big Tobacco aggressively targets low- and middle-income countries (LMICs) with larger populations and weaker regulations, high-income countries are also susceptible to industry interference. For instance, the UK, which scored the highest ranking in 2019, slipped to fourth place as a result of connections between industry and government ministers that have since taken office, as well as increased industry participation in government consultations.

COVID-19 Exploitation by Tobacco Industry to Gain Favor for Policy Changes

The report provides numerous examples of such exploitation, including:

  • Bangladesh. British American Tobacco (BAT) Bangladesh provided PPE to public hospitals, and the Ministry of Industries wrote to various agencies asking them to cooperate with both BAT and Japan Tobacco International during the COVID-19 shutdown.
  • Costa Rica. Philip Morris International donated artificial respirators to hospitals. The company launched its heated tobacco product (HTP) IQOS product in the country this year.
  • Kenya. BAT Kenya contributed 300,000 liters of sanitizer to government agencies. Tobacco was then listed as an “essential product” during the pandemic.
  • Indonesia. PMI’s local subsidiary, PT HM Sampoerna Tbk, used donations of sanitizer, PPE, and other goods for marketing and media coverage. The company also requested policy changes, such as asking the local government of Bali to roll back restrictions on outdoor tobacco advertising.

The tobacco industry has also intensified lobbying to enable government acceptance and industry promotion of new e-cigarettes and other “heated” tobacco products. Philip Morris International lobbied for the promotion and sale of its HTP, IQOS, in at least 12 countries which resulted in the government reversing a previous ban on HTPs. The government also allowed the sale of HTPs after Philip Morris International threatened to withdraw operations, and lowered levels of taxation on HTPs compared to cigarettes.

Countries are ranked on a scale of 0 to 100, with information provided by civil society groups in participating countries – the lower the score, the lower the overall level of tobacco industry interference.
India and South Africa Banned Some Tobacco Sales in Pandemic

On the plus side, governments such as India banned the sale of smokeless tobacco products, like chewing tobacco which is often spat onto the street. South Africa went a step further and banned the sale of cigarettes entirely between March and August, as did three municipalities in the Philippines. Mexico prohibited the sale of e-cigarettes, while the USA listed vape, smoking, and cigar shops as non-essential businesses that must close.

Civil society can expose and counter industry interference, but it is in the hands of governments to halt it altogether. They need to implement the recommendations in the report.

In its report, STOP advised the following measures governments can take to identify and prevent tobacco industry interference, including: preventing tobacco industry participation in policymaking, avoiding unnecessary interactions with the industry and ensuring transparency of meetings that do occur, and removing benefits and incentives for the industry.

“The message to governments is do not take the bait when it comes to industry offers,” said Mary Assunta, a partner in STOP and Head of Global Research and Advocacy at the Global Centre for Good Governance in Tobacco Control (GGTC). “With tobacco, there are always strings attached and ultimately the cost is paid in human lives.”

She added: “Governments can hold tobacco companies liable for the harm they cause instead, offering a win-win for the economy and health that is especially important during the coronavirus pandemic.”

Image Credits: STOP , STOP.

Frontline healthcare workers screening an individual for cardiovascular disease in Karnataka, India.

COVID-19 and non-communicable diseases (NCDs) are combining as a “syndemic” that reinforce each other and disproportionately impact the most vulnerable communities in every country during the pandemic period, said experts at a NCD Alliance panel on Thursday. 

However, primary health care workers, particularly nurses, who are the backbone of routine NCD responses have been particularly stretched during the pandemic, challenging NCD progammes. The panellists were speaking at a session on “COVID-19 and Noncommunicable Diseases: a healthcare workforce perspective.” The session focused on shared experiences and challenges of continuing care for those with NCDs in the midst of the COVID-19 pandemic in Rwanda, the United Kingdom, and India. 

Overall, people with NCDs are at an increased risk of serious COVID-19 disease and death. Approximately one fourth of the global population is estimated to have an underlying condition that increases their vulnerability to COVID-19, mostly due to NCDs. 

“In many disadvantaged communities, COVID and NCDs are experienced as what is increasingly being termed as a syndemic, a co-occurring synergistic pandemic that is interacting with and increasing socioeconomic inequalities,” said Katie Dain, CEO of the NCD Alliance. 

Noncommunicable diseases, including cardiovascular disease, hypertension and diabetes, are the world’s leading source of premature death, disease and disability, killing 15 million people annually. 

The pandemic has caused widespread disruptions in routine health services, screening, diagnosis, treatment, and palliative care for those with NCDs. Delays in diagnosis could lead to more advanced diseases and interruptions in therapies risk the wellbeing, recovery and survival of NCD patients. 

NCD diagnosis and treatment was the most frequently disrupted health service during the COVID-19 pandemic, according to a WHO survey released in June. Of the 122 countries surveyed, 39% reported that NCD-related clinical staff were deployed to provide COVID-19 relief, 46% reported a closure of population level screening programmes, and 32% reported insufficient staff to provide NCD services. 

Katie Dain, CEO of the NCD Alliance, at the media briefing on Thursday.

Said Dain: “What we can see is that COVID-19 has exposed the real damage that neglecting NCDs and cutting public health spending on health, including the health workforce, has done over many years in many countries.” 

Half of countries worldwide lack national guidelines for the prevention, early diagnosis, and treatment of the four major NCDs, cardiovascular disease, diabetes, cancer, and chronic respiratory disease. And only a third of countries can provide drug therapies and counselling services to their populations to prevent heart attacks and strokes, she said. 

“A joint approach is needed across education, training, employment, and investment in the workforce to provide integrated, people-centered care for NCDs,” said Elisabeth Iro, WHO Chief Nursing Officer. “Nurses…have a crucial role in health promotion, literacy and management of NCDs. They are key for connecting people to appropriate, timely information, services, referrals, follow-ups, and continuity of care.”

Prior to the pandemic, NCD services were already suffering from serious under-investment. The deployment of NCD healthcare workers to support the response to COVID-19 further exacerbated resource shortages.  However, there are bright spots. Examples of how health systems in Rwanda, the United Kingdom and India met those challenges creatively were showcased at the session. 

Rwanda
Gedeon Ngoga, a NCD nurse and educator in Rwanda.

Partnerships between hospitals and the government in Rwanda enabled a decentralized system of providing care and treatment to NCD patients during COVID-19. Private cars and ambulances were used to transport patients to the hospital for essential treatments and food was delivered to housebound people living with NCDs. 

“The integration and decentralization is one of the approaches and mechanisms to accelerate the achievement of the SDGs [Sustainable Development Goals] for universal access for all, especially for noncommunicable diseases,” said Gedeon Ngoga, NCD nurse and educator. 

United Kingdom

The disruption of NCD services and deployment of NCD clinical staff was exacerbated by a shortage of 40,000 nurses in the UK in the National Health Services at the start of the pandemic. The need for palliative and end of life care for cancer and other NCDs in community health services has doubled during COVID-19, taking a toll on an overstretched workforce.

However, one community that has benefited from increased support and care during the pandemic is homeless individuals. A programme was developed to provide hotel accommodations and health screenings, diagnosis and treatment for homeless communities, improving their NCD health profiles.

India

The overburdened health system in India is struggling to handle COVID-19, as the country approaches 9 million total cases. The strict lockdown enforced from March to July had far reaching consequences for people living with NCDs and their livelihoods. Many could not access essential medicines and others had to choose between buying food or insulin. This led to the rationing of insulin, which is extremely dangerous and can cause diabetic ketoacidosis. 

“Many countries today are facing the double burden…the countries are not just battling the virus, but also the overburden of NCD-related challenges,” said Apoorva Gomber, a doctor working in Delhi. “The COVID-19 crisis has opened up a window of opportunity and it is up to us to acknowledge the overburdened health system in each country and raise the urgency of ensuring equitable access to health care.”

Mobile medical service set up in Karnataka state, India to assist vulnerable populations.

Image Credits: Flickr – Trinity Care Foundation, NCD Alliance, Flickr – Trinity Care Foundation.