Commission for Narcotic Drugs meets in Vienna this week, in a hybrid virtual and in-person meeting

The UN Commission on Narcotic Drugs voted on Wednesday to remove cannabis and cannabis-derived substances from its “Schedule IV” list of the world’s most dangerous narcotics.

The move comes nearly two years after the WHO recommended to the UN Secretary General that cannabis and cannabis resin be removed from Schedule IV of the 1961 Single Convention on Narcotic Drugs – a classification of drugs with “particularly dangerous properties”, including narcotics such as fentanyl, heroin and other opioids.

While the long-delayed decision is non-binding for countries – it is expected to clear the way for more national legislation that would enable more scientific research into medical cannabis and cannabis derivatives, including non psychoactive cannabidiol (CBD).

There has been a surge of interest over the past decade in the therapeutic use of cannabis as “medical marijuana”, particularly for chronic pain management.

“Medical marijuana”, e.g., cannabis grown and prescribed for some form of therapeutic treatment, had been legalized in 30 countries around the world, ranging from Argentina, Chile, Canada, Germany, Greece, Israel, Switzerland, Turkey, and Zimbabwe, and some states in United States.

Recent years have also seen a major uptake of non-psychoactive cannabis derivatives, particularly CBD – with one brand-name formulation “Epidiolex” gaining US Food and Drug Administration approval for treating a rare form of childhood epilepsy. Other studies have suggested that CBD may also have potential therapeutic uses against anxiety, depression and as adjunctive therapy to common anti-psychotics.  Despite the increasing evidence about potential therapeutic benefits,  mainstream medical researchers have often been hamstrung by continued tight legal restrictions on production, sale and trade in cannabis, as a result of the Schedule IV international classification, which can stymie legitimate research.

At a meeting in November 2018, the WHO Expert Committee on Drug Dependence (ECDD), recommended that cannabis and cannabis-derived products be removed from the list of the most dangerous opoid and narcotic drugs.  Those recommendations were transmitted in a letter from WHO Director General Tedros Adhanom Gheyebresus to UN Secretary General Antonio Guterres in late January of 2019. However, the UN Commission meeting in March of that year postponed consideration of the WHO proposal – due in part to objections from members states at the time, including the United States, to the reclassification.

In Tuesday’s session, the 55 member states attending the Commission voted 27 in favour of the WHO recommendation and 25 voted against, while one abstained, clearing the way to greater recognition of the medicinal and therapeutic potential of the commonly-used but still largely illegal recreational drug.

The United States cast its vote in favor of removing cannabis from Schedule IV of the Single Convention while retaining them in Schedule I, saying it is “consistent with the science demonstrating that while a safe and effective cannabis-derived therapeutic has been developed, cannabis itself continues to pose significant risks to public health and should continue to be controlled under the international drug control conventions”.

 

WHO Expert Committee Recommendations 

The 2018 recommendation of the WHO Expert Committee on Drug Dependence concluded that: “The evidence presented to the Committee did not indicate that cannabis plant and cannabis resin were particularly liable to produce ill-effects similar to the effects of the other substances in Schedule IV of the 1961 Single Convention on Narcotic Drugs. In addition, preparations of cannabis have shown therapeutic potential for treatment of pain and other medical conditions such as epilepsy and spasticity associated with multiple sclerosis. In line with the above, cannabis and cannabis resin should be scheduled at a level of control that will prevent harm caused by cannabis use and at the same time will not act as a barrier to access and to research and development of cannabis-related preparation for medical use.”

However, the committe recommended that cannabis should still remain on the list of Schedule 1 controlled substances, which is the least restrictive classification under the 1961 Convention,  due to: “the adverse effects associated with long-term cannabis use, including increased risk of mental health disorders, such as anxiety, depression and psychotic illness. Regular cannabis use is particularly problematic for young people, because of its effects on the developing brain.”

The committee recommendation came shortly after the US Food and Drug Administration in August issued the first-ever approval of a CBD oral solution, Epidiolex, to treat certain forms of very severe childhood epileptic conditions, including Dravet and Lennoz-Gastaut syndrome.

Regarding CBD, the WHO committee noted that it had recommended that “preparations considered to be pure cannabidiol should not be scheduled within the International Drug Control Conventions at all.”

Cannabidiol “does not have psychoactive properties and has no potential for abuse and no potential to produce dependence. It does not have significant ill-effects,” the committee added, reiterating its findings once more in this year’s report. “Cannabidiol has been shown to be effective in the management of certain treatment-resistant, childhood-onset epilepsy disorders. It was approved for this use in the United States in 2018 and is currently under consideration for approval by the EU.”

Image Credits: @CND.

A man struggles with smoke from the Silverado Fire in California, October 2020

As the world’s eyes are fixed on the pending roll-out of new Covid-19 vaccines, a team of 120 leading health and climate experts have called on global leaders to use the momentum of the pandemic response to accelerate climate action, just ahead of the five-year anniversary of the landmark Paris Agreement to limit global warming to “well below 2°C.”

The expert assessments were summarised in the 2020 Lancet Countdown on Health and Climate Change, released Thursday. The report finds that record heat waves and wildfires in Australia, North America and Europe, deadly dengue expansion across Latin America; and undernutrition, floods, and droughts in China, South East Asia and Africa, are creating unprecedented threats to health and wellbeing around the globe.

Still Time For Global Reset

Despite their gloomy assessment, other climate news suggests that there is still time for a global reset. Should China, Japan, South Korea and others deliver on recently-announced net zero emission targets, the 2015 Paris Agreement’s ambitious climate goals could be “within reach”, according to an analysis by the Berlin-based Climate Action Tracker, published on Tuesday.

“The Climate Action Tracker (CAT) has calculated that global warming by 2100 could be as low as 2.1°C as a result of all the net zero pledges announced as of November 2020,” stated the independent scientific group, which measures and models governments’ climate pledges and actions against the goals of the 2015 Paris Agreement.

A recent wave of “net zero” emissions pledges announced this autumn by China, South Africa, Japan, the Republic of Korea and Canada have even “put the Paris Agreement’s 1.5°C temperature limit within striking distance,” states the latest report of the Climate Action Tracker (CAT).

As of November 2020, 127 countries “are considering or have adopted” net zero targets, the group said. Together, those account for some 63 per cent of global emissions. In addition, the incoming US administration of president-elect Joe Biden has pledged to rejoin the Paris Agreement and act more aggressively on climate change. Emissions are, nonetheless, still projected to increase until 2030, despite a small dip this year due to the COVID-19 pandemic.

“The year 2020 can be a global leap year for climate neutrality, so that we can reduce global emissions by 45 per cent by 2030, said UN Secretary General Antonio Guterres, speaking at a major address at Columbia University on the state of the planet. He recalled the vital link between climate, environmental stability and human health, saying, “Nature feeds us clothes us, quenches our thirst”, noting that health impacts from degradation come through multiple pathways, urban, air pollution, and environmental degradation: “Sound chemicals management could prevent some 2.6 million deaths per year.”

Lancet – Forty Global Indicators Still Show Worsening Impacts On Health

Even so, the 2020 Lancet report underscores how global warming that is already occurring is exacerbating the health impacts of the COVID-19 pandemic and vice versa.  The report, which involved 120 experts from 35 institutions like University College London, the World Health Organization and the World Meteorological Organization, found consistently worsening trends in all 40 global indicators that measured the health, social and economic impacts of climate change, revealing that health systems are still ill-prepared to deal with its deadly repercussions.

Maria Neira, WHO Director of Environment, Climate Change and Health

“The pandemic has shown us that when health is threatened on a global scale, our economies and ways of life can come to a standstill,” warned Ian Hamilton, executive director of the Lancet Countdown. “The threats to human health are multiplying and intensifying due to climate change, and unless we change course, our healthcare systems are at risk of being overwhelmed in the future.

“With trillions being invested globally in economic support and stimulus there is a genuine opportunity to align the responses to the pandemic and climate change to deliver a triple win – one that improves public health, creates a sustainable economy and protects the environment,” said the World Health Organization’s Maria Neira, who is at the helm of the Organization’s climate change and health efforts.

”But time is short. Failure to tackle these converging crises in tandem will [end up] moving the world’s 1.5C target out of reach and condemning the world to a future of climate-induced health shocks.”

A Comprehensive Report

This year’s report is more comprehensive than ever, featuring new indicators to measure the extent of heat-related mortality and its devastating economic costs, among other indicators on migration, urban green spaces and low-carb diets.

The authors show that climate change is knocking on Europe’s doorstep as well, triggering thousands of deaths a year from heat-related shock waves, damaging crop yields of staple grains, and facilitating the spread of mosquito-borne infections like dengue, with devastating costs to societies, healthcare systems and economies that are already strained.

The incentives to tackle climate change together with Covid-19 seem more enticing than ever, as limiting global warming to 1.5°C by 2100 could generate a net global benefit of US$264–610 trillion, which is at least triple the size of the global economy in 2018.

Higher temperatures are driving dengue spread to new regions

The World Doesn’t Have The Luxury Of Dealing With One Crisis At A Time 

Tackling climate change also bodes well with pandemic preparedness and prevention plans, since human encroachment into wildlife habitats, intensive farming, and deforestation promote both climate change and the emergence of “zoonotic” diseases like COVID-19. In fact, the world doesn’t have the luxury of dealing with one crisis at a time, added Hamilton in a press release on Wednesday night.

To reach the Paris Agreement’s targets by 2030, the world must reduce carbon dioxide emissions by 7.6% every year, which is more than five times higher than current government ambition, found the report. And although such changes seem out of reach, climate change is becoming more expensive to treat every year, given that a five-year delay in action would require a 15·4% reduction in carbon dioxide emissions every year to reach the set targets, representing a ten-fold increase in current government ambition. 

Europe, The World’s Most Vulnerable Region To Heat-Related Shock Waves

Perhaps surprisingly, the authors found that in 2018, Europe was the world’s worst affected region by heat-related shock waves, triggering over a 100,000 deaths that year, mostly in older people, people with disabilities or pre-existing medical conditions, as well as those working outdoors or in non-cooled environments. The costs, say the authors, are equal to a whopping 1.2% of regional gross national income. 

A rise in temperatures in Europe, even by seemingly small amounts, is also facilitating the spread of infectious diseases like dengue to the region. The global climate suitability for the two main mosquitoes that carry dengue – the Asian tiger and yellow fever mosquitoes – have in fact increased by 41% and 25% since the 1950s, found the report.

Meanwhile, rising temperatures have made Africa’s highlands 40% more suitable for malaria transmission, and 150% more suitable in the Western Pacific region, in comparison with the 1950 baseline.

The outlook for food security is rather bleak as well, with consistently dwindling crop yields for staples like maize, winter wheat, soybean, and rice across the world. In Europe, for instance,  the crop growing season for maize was reduced by 20 days in 2019, a 14% reduction compared to the global averages between 1981–2010.

Maize growth duration has decreased since 1981–2010

Huge Losses

Increasingly warm temperatures are also triggering huge economic losses. Just last year the world lost 302 billion work hours due to climate change, or 103 billion hours more than two decades ago. These effects are more strongly felt in the construction sector in high-income countries, in comparison to low- and middle-income countries where extreme heats are most deeply felt in agriculture. In 2018, India and Indonesia lost 3.9 to 5.9% of their GDP because of lost outdoor labour. In India alone, this amounts to 100 billion hours of potential work lost to rising temperatures in 2019, compared with those lost in 2000.

If the world fails to intervene, up to 565 million people living in coastal areas, about three quarters of the total European population, may be forced to leave their homes due to rising sea levels. 

Progress Welcome, But Only 9% of Countries Have The Funds To Implement Health & Climate Adaptation Plans

Fortunately, there is some good news. Coverage of health and climate change in the media has increased by 96% worldwide between 2018 and 2019, and research in the field has increased by a factor of eight. Government engagement in climate change has also increased, especially for small island states and lower-income countries that have led the trend. And in 2019, government spending on health system adaptation rose by almost 13% to $18·4 billion. 

However, governments have a lot of work to do to implement effective multi sectoral strategies, warned the report, noting that governments “remain unable” to fully implement their plans for national health adaptation – even though two thirds of global cities surveyed anticipate climate change to seriously compromise public health infrastructure.

In fact, only half of governments surveyed have drawn up national health and climate change adaptation plans, and only 9% have the necessary funds to fully implement them.

An earlier version of this story was published on Thursday morning in collaboration with Geneva Solutions, a new non-profit Geneva platform for constructive journalism covering International Geneva.

Image Credits: AP, Climate Action Tracker, Maria Neira, The Lancet.

Clinical trial volunteer receives injection of vaccine candidate developed by Pfizer and BioNTech.

Pfizer’s COVID-19 vaccine, a cutting edge mRNA technology produced jointly with the German firm BioNTech, was authorized for use on Wednesday by the United Kingdom – making it the vaccine the first to be rolled out for commercial public use as early as next week. 

The vaccine was authorised Wednesday morning for emergency use by the Medicines and Healthcare products Regulatory Authority (MHRA), eight days before the US FDA is expected to meet on the Pfizer application for regulatory approval there, while the timeline for broader European approval of Pfizer’s candidate, as well as a similar Moderna vaccine, may not come until early 2021, with the European Medicines Agency set to meet 12 January. 

The timeline for vaccines approval and distribution elsewhere in the world is expected to follow after the US FDA and EMA approvals. But massive distribution of COVID vaccines in many low- and middle-income countries still depends on rapid approval of a much cheaper AstraZeneca  vaccine type, which uses a more conventional immunization strategy, in the form of a weakened adenovirus, to deliver a fragment of SARS-CoV2 viral protein and stimulate immunity. It can also be storaed in a refigerator, unlike the Pfizer and Moderna vaccines that require freezer or deep freezer storage.

The UK’s Department of Health and Social Care announced, its approval of the Pfizer vaccine, following a review of the MHRA’s recommendation. The MHRA was vested with the power to approve new COVID vaccines under special governmental regulations in force ahead of 1 January 2021, when the medicines agency will become fully responsible for medicines authorisation in the UK following  Brexit. 

“The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer/BioNTech’s COVID-19 vaccine for use,” stated the government announcement. “This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness.” 

A UK Department of Health and Social Care spokesperson said: “The vaccine will be made available across the UK from next week. The NHS has decades of experience in delivering large-scale vaccination programmes and will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination.

The Department urged the public to continue to abide by current COVID-19 restrictions, saying: “To aid the success of the vaccination programme it is vital everyone continues to play their part and abide by the necessary restrictions in their area so we can further suppress the virus and allow the NHS to do its work without being overwhelmed.”

UK authorities said that they had some 40 million doses on immediate order and  800,000 doses ready to deploy over the next few days. 

Global Health Leaders in UK and World Welcome Step

The reaction from UK and global health leaders was swift: 

WHO’s Dr Tedros Adhanom Ghebreyesus said in a tweet: “This is the first country to authorize the Pfizer/BionTech #COVID19 vaccine for emergency use and expects to start rolling it out as soon as next week. “

Chris Whitty, Chief Medical Officer, United Kingdom.

England’s Chief Medical officer, Chris Whitty, warned that the approval doesn’t mean that people should begin relaxing social distancing and other COVID-19 prevention measures yet.

“This is excellent news and a step towards normality,” he said, but added, “It will take until spring until the vulnerable population who wish to are fully vaccinated. We can’t lower our guard yet.”  

Professor Sir Robert Lechler, President of the UK Academy of Medical Sciences, called it, “brilliant news and a historic moment providing a light at the end of a gloomy tunnel.

“This vaccine is an example of the extraordinary power of biomedical science demonstrating how medical research has played a vital role in helping us understand and respond to this virus. It will take time to achieve mass vaccination so we must not relax our guard against COVID-19 yet, in fact now is the time to strive to stay safe more than ever.

“The Pfizer-BioNTech COVID-19 vaccine does come with challenges such as storage at around -70C which is why I am pleased that there are other promising vaccines that could be approved for use soon, and I look forward to more good news within the comings months.

“To ensure good uptake of COVID-19 vaccines it is essential that public health messages around vaccination reach all parts of society, regardless of age, socio-economic background, ethnicity or language. The best way to do this is work hand in hand with different communities to understand the questions they have, to co-produce effective messages and understand the best ways to share them.

He also urged that people continue practicing measures to prevent infection, saying: “This vaccine is a fantastic new tool in our defences against the virus, but we all still have a part to play in preventing the spread of COVID-19. I urge everyone to keep sticking to the measures, including the use of face coverings, social distancing, following the guidance on tier restrictions and isolating when sick. It is vital we all stay healthy to enable the NHS to support the roll out of this new vaccine.”

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) called it “good news for people in the UK, especially the health care workers, the elderly and people who have underlying medical conditions… It is also good news in terms of scrutiny that the vaccine is safe and effective; based on clinical trial testing designed to represent all races, genders and ages, as well as people with medical conditions.”

UK Approval is ‘Huge Step’ –  But For The Entire World – We Will Need A Range of Vaccines That Work Across Different Groups & Settings 

Dr Charlie Weller, Head of Vaccines at the UK-based Wellcome Trust, described the announcement as “historic day and an important moment at the end of an incredibly difficult year. For a vaccine to be developed, receive emergency approval and be ready to roll out in less than a year for a new virus is completely unprecedented. The speed of development for this and other vaccine candidates is testament to an extraordinary, collaborative, global research effort.

“As normal for any vaccine, there will be a need for close and continued monitoring for safety and efficacy as it is delivered. We will also need to continue tracking and improving our understanding on how long the protection lasts. We must recognise that not everyone will have a vaccine immediately or even early next year. It is critical that groups most at risk, such as the elderly and frontline healthcare workers, are prioritised to receive the first doses.

But while the decision “clears the path for this vaccine to be rolled out to a wider population, there are now important considerations and significant logistical hurdles ahead. We have never attempted to roll out any vaccine at this sort of scale and at this sort of speed anywhere in the world,” Weller said. Wellcome is a major player in the WHO’s ACT Accelerator global drugs and vaccines distribution initiative, as well as funding R&D on a range of other COVID-19 vaccines, considered necesary to attain broad global coverage:

And while the UK decision signals: “a huge step forward to end the pandemic… if we are to have enough doses for the entire world, we will need a range of vaccines that work across different groups and settings. It is therefore vital there is continued global investment in developing a wide range of candidates. Alongside vaccines, we will need effective treatments, tests and most of all global collaboration, to overcome COVID-19.”

“Ït’s going to be extremely frustrating, Modern CEO Admits – There Won’t Be Enough for Most People In the World Right Away  
Stéphane Bancel, Chief Executive Officer, Moderna.

Said Stéphane Bancel, Chief Executive Officer, Moderna, in an interview with the World Economic Forum late Wednesday afternoon, his company is on track to produce 500 million to a billion doses of its mRNA vaccine next year. The vaccine, which has less demanding cold storage requirements than Pfizers, is suitable to be shipped and used in many, if not, most places of the world.

And in terms of the trial results, “the piece I got the most excited about when I got the data from my team was that we had 30 severe cases, and all 30 were in placebo – meaning that if you get the vaccine, you probably will have no disease symptoms, but if you have any sign of the disease, it will be a very mild disease…. And as we know, what has had a big impact on human life, public health and economy is a cascade of severe diseases, and death, which has driven the lockdowns, social distancing and all the suffering and mental suffering that that we know as is going on as we speak.”

He also publicly credited the US$ 1 billion in US government funding that supported Moderna’s clinical trials as “being very helpful” in lowering the price the company will finally charge for the drug.  “It is going to help, of course, in terms of affordability and access around the world, because the US basically picked up the tab to pay for the development of a product.”

Still, while Bancel said his company was on track to have “20 million doses” of the Moderna vaccine ready to go before the end of the year, he also admitted that the speed at which global vaccine distribution unfolds is likely to be initially “extremely frustrating for the general population, how slow it is going to feel . .. because there won’t be enough for most people in the world, definitely in the first quarter, definitely in the second quarter, and most probably for the entire year – if you are worrying about people around the world and not only in rich countries.

“We know that in rich countries, not only people have cash, but they also have less people,” Bancel said. “Aand so it’s a math problem… of just numbers of people that you need to vaccinate, and so I think that around the world, it is going to be very frustrating that people will want to get the vaccine… I think there’s going to be a lot of people wanting a vaccine very quickly to get back to normal life.”

AstraZeneca Says Its Vaccine Will be Low Cost & Sturdy
Mene Pangalos, Executive Vice-President, Biopharmaceutical Research and Development, AstraZeneca.

On a more positive note, Mene Pangalos, Executive Vice-President, at AstraZeneca, said that the company’s vaccine, which is less temperature sensitive and is to be priced as low as $US 3 per dose, is poised for deployment early in 2021, and “will make a dent” in the pandemic, along with the Pfizer and Moderna vaccines.

Said Pangalos: “We have, as part of our commitment to helping deal with a pandemic, committed to doing and delivering and supplying the vaccine during the pandemic, not for profit. And we have around 3 billion doses, ready to go. By the end of, 2021, many of those several hundred million of those doses available in the first quarter of next year.

“So I do think with the data we have, we have a vaccine that is approvable that will make a dent in the pandemic along with vaccines from from Pfizer and Madonna. And I think the supply as early in the year as possible around the world is going to be very important to try and make the dent that we need, on this virus and getting us all back to some normality,” he said.

Henrietta Fore, Executive Director, United Nations Children’s Fund (UNICEF).

Along with vaccine costs and production, the logistics of mass, worldwide vaccine distribution are unprecedented, said UNICEF’s executive director, Henrietta Fore, also appearing at the WEF event. She spoke about the importance of supporting the WHO co-sponsored COVAX vaccine initiative to reach the highest risk groups worldwide with new COVID vaccines by end 2021:

“Currently, UNICEF procures and delivers about 2 billion vaccines doses, a year,” Fore said. “And that is to cover primarily childhood diseases… but COVAX is now asking us to double that number for next year,” she said, referring to the COVAX goal to distribute up to 4 billion vaccine doses, so as to reach 2 billion people next year with the two-dose vaccines. “And it’s to the lowest and the middle, low income countries so it’s the hardest places. So the challenge is enormous. It’s got to be a big public private partnership.”

Help is needed to streamline supply chains and as well as cold chains, she added:

“Currently we are used to vaccines that can move in relatively cool temperatures but not ultra-cold,” she said referring to the Pfizer vaccine that needs -70 C storage along with Moderna’s counterpart, which requires at -20 storage long term, and -2 to -8 C for a month. “We need supply chain logistics and transportation sectors that are all working together, we need to prioritize the transportation of vaccines, so that in the lessened amount of cargo space that we can get the vaccines out there and across the boundaries and into the countries.”

Fragile health systems also need to be bolstered, said Fore, “we really have to think about the fragility of many of these countries, health systems. We’ve been just working on that in Sudan recently.. in the poorest countries it’s particularly important – financial support, technical support and equal investment in the systems that will deploy COVID-19.”

Public Funds Also Poured Into Pfizer/BioNTech Vaccine

While more attention has been given to the public funding accorded to the startup Moderna, the German government in September paid up to € 375 million to  BioNTech to help speed up the development of the Pfizer-BioNTec mRNA vaccine.  That followed a European Investment Bank loan of  €100 million in June to “allow the company to expand its manufacturing capacity in order to supply the vaccine fast worldwide in response to the pandemic.”   

As a result of the public funding, the price per dose for the BioNTech/Pfizer vaccine in Europe will reportedly be about US$ 18.34, according to a recent Reuters report. That is about a US$1.20  less than the reported US$19.5 the United States reportedly agreed to pay in July, when it purchased 100 million doses, with an option to buy a further 500 million under terms to be negotiated separately. 

Pfizer said only that the company is using a tiered pricing formula based on volume and delivery dates, and that the EU deal had represented the largest initial order of its vaccine candidate to date. “We are not disclosing further details of this agreement,” it added.

Medicines access advocates are quick to point out that despite the hundreds of millions of dollars in public funds that have been poured into both the Pfizer BioNTech project, as well as a similar Moderna vaccine, prices of both that will be charged to governments have remained closely guarded secrets.    

In addition to the late-stage research grants and loans, the foundational research into the mRNA vaccine delivery mechanisms was also publicly supported, access advocates have pointed out. That work, carried out by two researchers, Katalin Karikó and Drew Weissman, at the University of Pennsylvania, received US government funding, according to an analysis of the R&D funding by Knowledge Ecology International (KEI).  

Karikó and Weissman later licensed their inventions “non-exclusively” to Moderna and BioNTech RNA,  the company that has been collaborating with Pfizer for the development of a mRNA vaccine.  But due to its investment, the US government still holds some rights to six of the 11 patents that were instrumental in developing the mRNA vaccines of both companies, 

KEI’s Thiru Balasubramaniam observed that the transparency of COVID-19 vaccine prices could also emerge as a flashpoint in discussions that will get underway Thursday among WHO member states, in light of the streams of public funding that has gone into vaccines development, . The member states are meeting to discuss pharma’s R&D costs and medicines shortages, in the context of a renewed push to implement the WHO’s Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property.

 “President Trump prides himself on being the consummate negotiator. He wrote ‘The Art of the Deal’; he didn’t get such a good deal here,” observed Balasubramaniam. Meanwhile, he said, referring to the UK’s approval today:  “the heirs of Hengist and Horsa are first in the queue.”

Image Credits: Pfizer, BioNTech, Number 10, WEF.

Special Representative for Global Health Diplomacy, Ambassador Deborah Birx.

Ibadan. While this year’s media coverage of the HIV epidemic has largely focused on COVID-related disruptions of services, deeper running trends and attitudes that stigmatize people found to be HIV-positive need greater attention, said US Global AIDS Coordinator and Special Representative for Global Health Diplomacy, Ambassador Deborah Birx, in a special media briefing on the occasion of World AIDS Day. 

Stigma and discrimination are not specific to HIV/AIDS, she emphasized, but they are particularly insidious in the case of people living with HIV. Stigmatization deters people from seeking life-saving testing and treatment on the one hand, and on the other can lead to the transmission of infections to others.

“We have to create an environment where individuals do not see that there are barriers to their ability to access either prevention, or treatment service. This is the work that we have to still do,” Birx told Health Policy Watch at a briefing organized by the South Africa-based Africa regional Media hub of the US Government.

The year 2020 marks nearly 40 years since the discovery of the AIDS virus in 1983, and 32 years since the first World AIDS Day in 1988. In contrast to the 1990s, when the first available anti-retroviral treatments were expensive and out of reach to most people in parts of Africa and the developing world where the AIDS pandemic was raging, some 26 million people living with HIV/AIDS today are now regularly using ARV therapies. But that still falls short of the 30 million target for 2020, that was set before the COVID pandemic began.

Overall, it’s estimated that some 12.5 million people worldwide still don’t have access to lifesaving ARVs.

Since 2003, the US government has invested more than $85 billion in the global HIV/AIDS response through its PEPFAR initiative (President’s Emergency Plan for AIDS Relief), which extends across more than 50 countries today.

That has saved 20 million lives, preventing millions of HIV infections, and moved the HIV/AIDS pandemic from crisis toward control, Birx said. But it has not stopped the disease from being a source of stigma for people living with it.

“So it tells me that there’s still a stigma around keeping people healthy and prevention programming versus treatment programs, no matter where we work around the globe,” she observed.

She added that there remains great disparities in the means by which countries and policies address stigmas around HIV/AIDS. Great progress has been made in some countries, notably South Africa, where the epidemic raged two decades ago, but the situation has worsened elsewhere in Sub-Saharan Africa.

LGTBQ+ Groups At Particular Risk From Stigmatization- Freedom of Association Under Attack 
Winnie Byanyima, Executive Director UNAIDS.

While access to treatment has improved in many parts of the world, things have actually gotten worse in many parts of Sub-Saharan Africa, as a result of stigmatization against key at-risk groups, said Onyekachi Onumara, Nigerian-based senior program officer at the Rural Health Foundation, in a separate interview with Health Policy Watch.

“There is much more stigma around key populations in Sub-Saharan Africa than there was five or six years ago. We have to work on this comprehensively. We also have to remember that economic fragility also brings additional risk to women and children,” Onumara told Health Policy Watch.

Gay men and sex workers are among the groups most often targeted by legal as well as social pressures that prevent them getting acces to HIV services, noted UNAIDS Executive Director Winnie Bynaymia, during the launch of last week’s 2020 Global AIDS Update.

Byanyima cited her home country, Uganda, where both groups are targeted by serious stigmatisation, backed with state legislation, including the 2014, Anti-Homosexuality Act, making homosexual acts punishable by life in prison. Such laws are common in conservative cultures of Africa as well as the Middle East and Asia. And in some countries, a backlash by conservative cultural and religious groups has seen them reinforced only recently.

“For LGBTQI laws, that’s where our criminal laws are hardest, and are not being unwound. So we have to understand this conservative backlash and see how to address it. I think such forces can only be rolled back through movement building. We cannot hope to have an open space unless we mobilize people and change attitudes,” Byanyima said last week.

“Sometimes [we] think we can solve the problem of HIV AIDS through a biomedical approach. We can’t. There is no treatment, no pre-exposure prophylaxis, ARV or whatever, that will reach the hands of a gay man in my country Uganda where the criminal law is being enforced in a harsh way,” she said.

She said the world needs to push back against conservatism that is making it harder to move forward on women’s rights or the rights of all sexual identities.

“I say this really sincerely,” she said. “Free media, freedom of association, freedom of speech, these are also under attack. And I think that for us, if we want to fight AIDS, we do need to protect those core tenants of a liberal democracy.”

Invest in Peer-Led HIV/AIDS Services 

As one means of overcoming stigma, Birx said more money needs to be invested in supporting and protecting peer-led HIV/AIDS services.

“We need to overcome the structural barriers that really plague key population programs, particularly in Sub-Saharan Africa. In many places around the globe, peer-led service delivery is much more successful outside of the public sector for many reasons.

Peer led services are more able to cope with “Stigma discrimination – It’s how people are dressed and how people are seen and spoken to and spoken with,” Birx said.

Global AIDS Response Off Track Before COVID-19

While the global AIDS response was off track before the COVID-19 pandemic, the onset of lockdowns and travel restrictions created additional setbacks. While services have since “rebounded” in many countries, according to the World Health Organization, UNAIDS has warned that the the world may still see an estimated 123,000-293,000 more HIV infections and 69,000-148,000 more AIDS-related deaths between 2020 and 2022.

“The collective failure to invest sufficiently in comprehensive, rights-based, people-centred HIV responses has come at a terrible price,” said Byanyima. “Implementing just the most politically palatable programmes will not turn the tide against COVID-19 or end AIDS. To get the global response back on track will require putting people first and tackling the inequalities on which epidemics thrive.”

 

 

Image Credits: UNAIDS .

The plan aims to support 160 million people, including those disproportionately affected by the COVID-19 pandemic. In Soweto, South Africa, poverty and crowded conditions made lockdowns much harder.

More than 235 million people worldwide will require humanitarian protection next year: an increase of 40% in 12 months.

The United Nations (UN)has announced an appeal for US$35 billion, which it estimates will be required to support 160 million of those most in need of support, across 56 countries.

The Global Humanitarian Overview (GHO) 2021, published on Tuesday 1 December, has outlined 34 appeals designed to support vulnerable populations who are disproportionately affected by conflict, displacement, and the impacts of climate change and the COVID-19 pandemic.

“In 2020, COVID-19 altered the landscape of humanitarian response,” the abridged report stated. Analyses of the impact of the pandemic have been considered alongside pre-existing crises.

UN Under-Secretary General for Humanitarian Affairs and UN Emergency Relief Coordinator, Mark Lowcock

In a press briefing on Tuesday, UN humanitarian chief Mark Lowcock said that money will be used from the UN’s Central Emergency Relief Fund (CERF) to curb the increase in violence against women and girls caused by or linked to the pandemic.

Lowcook said in a statement: “The rich world can now see the light at the end of the tunnel. The same is not true in the poorest countries. The COVID-19 crisis has plunged millions of people into poverty and sent humanitarian needs skyrocketing. Next year we will need $35 billion to stave off famine, fight poverty, and keep children vaccinated and in school.

“A clear choice confronts us. We can let 2021be the year of the grand reversal –the unravelling of 40 years of progress – or we can work together to make sure we all find a way out of this pandemic.”

70% of the people targeted for aid in 2020 were reached, but total donations reached $17 billion – less than half of what is required in 2021.

The report can be read here. The UN statement is available here.

Image Credits: UN Photo/Mark Garten, Matt-80.

HIV treatment
Around 1.7 million children are living with HIV around the world, but high costs mean the number who receive treatment is only half that. A new agreement could see the drugs reduced from $400 to $36 per child.

Two groundbreaking agreements with pharma companies that should greatly expand access to WHO-recommended HIV drugs for children and adults in low- and middle-income countries (LMICs) have been announced by the Geneva-based Unitaid and Medicines Patent Pool (MPP).

The announcements, coinciding with World AIDS Day, celebrated on Tuesday 1 December, both involve cheaper versions or new formulations of the WHO-approved antiviral dolutegravir-based (DTG) treatments for HIV.

The initiatives aim to reduce the 12.6 million people around the world who lack access to effective ARVs – many of them living in middle- and upper-middle-income countries.

One agreement, between the Medicines Patent Pool (MPP) and ViiV Healthcare – is designed to improve access to DTG HIV treatment to adults, while still prioritising investment in drug innovation. The agreement clears the way for the generic production of the ViiV Healthcare formulation by generic manufacturers at a much reduced price in several upper-middle-income countries, including Azerbaijan, Belarus, Kazakhstan and Malaysia.

A second agreement, facilitated by Unitaid, would also open the way for generic production and sales of a dispersible paediatric formulation of DTG for a price of just US$ 120 per child as compared to US$ 480. The long-awaited agreement on production and sale of an HIV treatment designed specifically for children is thanks to a landmark agreement between Unitaid and the Clinton Health Access Initiative (CHAI) on support for the product.

75% Cost Reduction for Children’s HIV Treatment in LMICs

Around 1.7 million children are living with HIV around the world, but the number who receive treatment is only half that, due in part to a lack of or limited accessibility to effective drugs, properly adapted for children.

HIV drugs for children are often incorrectly dosed or bitter tasting, which makes it harder for children to adhere to their treatment.

A new dispersible formulation of DTG treatment – WHO’s foremost recommendation for treating people living with HIV – will be launched at a cost of $36 per child, following an agreement between generic manufacturers Viatris and Macleods which saw the price reduced from $400.

Philippe Duneton, Unitaid’s executive director, said: “Children in LMICs often wait years to access the same medications as adults, hindering their quality of life, or even resulting in preventable deaths.”

Incorrectly dosed treatments and bitter tastes mean that many children living with HIV respond poorly to antiretroviral treatment and, despite WHO having recommended DTG for children for nearly 2 years, there are no affordable drugs for small children (under 20kg).

The new 10mg DTG tablet, produced ViiV Healthcare, under the plan supported by Unitaid and CHAI, has been given a strawberry flavour, to ensure children’s adherence to the medication, and preventing some of the 100,000 child deaths annually from HIV. The new product will be made available initially in Benin, Kenya, Malawi, Nigeria, Uganda and Zimbabwe in the first half of 2021.

“Today we can finally guarantee that countries have rapid access to the appropriate formulations needed to fully implement WHO guidelines; so that no child is left behind,” said Dr Meg Doherty, Director of Global HIV, Hepatitis and STI Programmes at WHO. “Congratulations to all the partners involved for showing how quickly we can bring new formulations to market when we work together – clear proof that solidarity delivers results.”

“This groundbreaking agreement will bring quality assured dispersible DTG to children at a record pace,” Duneton added. “Ensuring access to this treatment will transform the lives of children living with HIV, helping them to remain on treatment and saving thousands of lives.”

The agreement is expected to save global health budgets an estimated US$60-260 million over 5 years.

MPP agreement  – New Adult DTG Formation For Azerbaijan, Belarus, Kazakhstan and Malaysia

For adults, a milestone licensing agreement will enable greater access to WHO approved antiretroviral DTG treatments for HIV, in several upper-middle-income countries, including Azerbaijan, Belarus, Kazakhstan and Malaysia. The four countries were excluded from a 2014 MPP licensing deal that covered dozens of other lower and middle income countries, because they were considered upper middle-income by World Bank definitions.

Under the terms of the new agreement reached between the Geneva-based Medicines Patent Pool (MPP) and the  pharma manufacturer ViiV Healthcare – generic manufacturers will be able to supply DTG regimens at a much-reduced prices, enabling greater access to HIV treatment in each country, MPP said.

Charles Gore, MPP Executive Director said in a statement: “Increasing access to life-saving medicines for low- and middle-income countries is at the core of our mission and we have been able to achieve that over the last 10 years through strong partnerships that span industry, generics manufacturers, governments and civil society. This new and first-of-its-kind agreement with ViiV Healthcare, that is specifically aimed at increasing access in these upper-middle-income countries, will mean that people living with HIV in Azerbaijan, Belarus, Kazakhstan and Malaysia will now have greater access to affordable and quality WHO-recommended dolutegravir-based treatment regimens.”

Meg Doherty, WHO’s Director of Global HIV, Hepatitis and STI Programmes.

In 2019, WHO recommended DTG as the preferred HIV treatment in all populations – including pregnant women – after two large clinical trials in the time since, however, have found that risks of birth complications are significantly lower than had been initially believed.

With reference to the announcement, Dr Meg Doherty, Director of Global HIV, Hepatitis and STI Programmes at the World Health Organization said; “WHO recommends the use of dolutegravir (DTG) as part of the preferred first-line and second-line regimen for people living with HIV, including pregnant women and those of childbearing potential. WHO welcomes this licence and through our regional and country offices have worked alongside governments and MPP to ensure that this agreement responds to people’s HIV treatment needs in these countries.”

Vinay Saldanha, Special Adviser to the UNAIDS Executive Director, said: “Voluntary licensing agreements have proven to be an important tool to improve affordability of newer ARV formulations and products in low- and middle-income countries (LMICs), through increasing generic competition.

“Several upper-middle-income countries, however, have not been able to benefit from several access to medicines initiatives, with growing barriers to procure more affordable ARVs in the generic pharmaceutical market. We hope that the current agreement will be the first of many to come, opening the doors for countries in other regions, which are still paying higher prices for innovative health technologies that could advance treatment outcomes.”

Medicines Access Advocates Criticize MPP Deal As Setting Unfavorable Precedent on Secrecy

Medicines access advocates, however, criticized the MPP’s mediated licensing agreement, saying that the organization had allowed for the royalty provisions made between the countries and ViiV and (which is controlled by GSK, with a minority shared held by Pfizer) to remain secret.  That, they said, runs contrary to MPP’s longstanding tradition of transparency in the agreements that it mediates between pharma companies holding patents or other production rights, governments and generic manufacturers.

Brook Baker, a professor at Northeastern University School of Law, USA, and a senior policy analyst with Health GAP (Global Access Project), said in a blog post: “The MPP for the first time ever is acceding to industry demands to redact the royalty terms from its published licenses. The MPP has historically been committed to full transparency of its licenses.

“Now upsetting that commendable principle … a key term in an MPP license will be hidden from public view. This is a major setback to the principles upon which the MPP was founded and it is also a dangerous precedent in the COVID-19 era, where companies are hiding behind claims of transparency to maximize profits and power. They are insisting that everything – their R&D contracts, clinical trial protocols, research data, pricing decisions, advance purchase agreements and option contracts are entitled to full confidentiality as ‘trade secrets’.”

He also charged that the price to be charged could still wind up being five or six times higher than the US$75 paid by low-income countries under the 2014 agreement.

“MPP also admits that generic licensees will in all likelihood price their generic versions substantially higher than the $75 per year secured through by the Clinton Health Access Initiative and others in 2014,” Baker said. “In fact, the MPP anticipates an eventual price in the range of $400-$500 per year, a sign of both inexcusably high tiered pricing by generic licensees and an excessive royalty charged by ViiV.”

In response, an MPP spokesperson said a price for the product hadn’t yet been set, but said it would be half or more of what it currently is in the countries involved:

“We don’t have a price yet. Following consultations with both governments and generic manufacturers, MPP is confident that affordable DTG and DTG-based combinations will have a price reduction of 50% to 70%. Estimates have been discussed with the governments of the countries during our consultations with them and this price is agreeable to them, and that this will enable a gradual transition to the WHO recommended regimen.

As for the secrecy around the royalties, the spokesperson said: “The royalty rates of the agreement were redacted from the published licence because it was considered commercially sensitive information by ViiV Healthcare who requested its redaction.

“MPP discussed with its independent Expert Advisory Group and Governance Board. In view of the importance of the agreement for access in the four countries and the requests from the four governments to facilitate access to these products as soon as possible, MPP exceptionally agreed to redact these clauses. The rest of the agreement is made public on the MPP website. MPP continues to be the global public health organisation with the highest level of transparency in its licensing agreements and commits to continued transparency in its licensing practices.”

Image Credits: Paul Kamau/ DNDi, NIAID, WHO.

The US has reported 2 million new COVID-19 cases in the past 2 weeks, over the Thanksgiving holiday and in the month leading to Christmas.

WHO officials have expressed concern about yet another spike in COVID-19 infections and deaths across the Americas, following the Thanksgiving holiday on Thursday, and in the run-up to Christmas – echoing concerns already being expressed by United States health authorities.

The US has reported 2 million new COVID-19 cases in the past 2 weeks: a striking new record, considering the country had not recorded more than 500,000 cases a week before November. As a result, US health officials have urged those traveling nationwide to take measures to stem a further increase.

“If you’re young and you gathered, you need to be tested about five to 10 days later,” said Deborah Birx, the White House COVID-19 response coordinator, in an interview with CBS News. “You need to assume that you’re infected and not go near your grandparents and aunts and others without a mask.”

With new infections from the Thanksgiving holiday, “we might see a surge superimposed upon that surge that we’re already in”, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in an interview with NBC.

The delay between the time of infection, first symptoms and actual testing will also delay nationally reported rates of infection, hospitalization and deaths, experts warned. 

“Probably what this means is three or four weeks after Thanksgiving, we will see more people die than otherwise would have,” said Michael Mina, epidemiology at Harvard’s T.H. Chan School of Public Health. “We’ll see more people get infected over Thanksgiving. And unfortunately, it will probably be a lot of older people who are gathering together with their families.”

The number of cumulative cases in the Americas as of 30 November 2020. (Johns Hopkins)
WHO: Do You Really Need To Travel?

At a WHO media briefing on Monday, Director General Dr Tedros Adhanom Ghebreyesus asked  the general public to carefully consider their choices over the coming holidays, saying: “The first question to ask yourself is, do you really need to travel?

“The COVID-19 pandemic will change the way we celebrate, but it doesn’t mean we can’t celebrate. The changes you make will depend on where you live.”

Dr Tedros also urged holiday shoppers to “avoid crowded shopping centres, and shop at less crowded times”. The United Kingdom recently announced that shops can stay open up to 24 hours to aid economic recovery in the Christmas build-up, following a 4-week national lockdown. If people travel, mix households or shop in person, social distancing measures should be adopted and masks should be worn, Dr Tedros added. 

In his NBC interview, Fauci gave similar advice: “If we can hang together as a country and do these kinds of things [mask wearing and physical distancing] to blunt these surges until we get a substantial proportion of the population vaccinated, we can get through this.”

Dr Tedros Adhanom Ghebreyesus, WHO Dicrector General.

 

WHO Urges Brazil’s President to ‘Take It Seriously’

In a rare calling out of a head of state, Dr Tedros also said Brazilian President Jair Bolsonaro should take the pandemic “seriously,” citing the steep rise in active cases in Brazil, which threatens to surpass the country’s July peak if adequate action is not taken.

“I just would like to add one thing, because I want the president to take it seriously,” Dr Tedros said. The number of cases in Brazil climaxed in July, with 319,000 cases per week recorded, which then dropped to around 114,000. “It is back again to 218,000 cases per week.”

More than 200,000 cases were reported in Brazil last week, and since the first week of November, the death rate has risen from 2,500 to nearly 3,900.

Dr Tedros described the situation as “very, very worrisome”, especially when local transmissions are considered in aggregate.

“In the case of Brazil, the disease numbers are going down in a number of states but rising in others,” said Dr Mike Ryan, Executive Director of WHO’s Health Emergencies Programme. “As they begin to see a rising number of cases, countries need to look at a national and sub-national level.”

He added that Brazil, and countries facing similar regional challenges, need to be “very, very clear and directed [in locating] where cases are jumping back up and what’s driving this rise in cases”.

Tailored and targeted interventions are vital in stemming local transmissions, but just as important is a country’s ability to maintain a low case rate after a successful intervention.

“Bring it down, keep it down,” said Dr Maria van Kerkhove, WHO’s COVID-19 Technical Lead. “We have seen so many countries that have brought transmission under control, but they haven’t been able to keep it low.” She added that countries should jump on regional outbreaks urgently “so that they don’t have the opportunity to seed into something further”.

Ryan added: “We are not just trying to get the COVID numbers down for the sake of getting COVID numbers down. We are trying to get the core with numbers down so the health system can get back to what it’s supposed to be doing.”

WHO Calls Out Mexican President’s Refusal To Wear A Mask

When asked about Mexican President Andrés Manuel López Obrador’s refusal to wear a mask at public events, WHO officials reiterated the need for political leaders to set a model for citizens, especially as cases continue to rise in many countries.

The president has been notorious in his refusal to wear a mask to prevent transmitting COVID-19, even telling reporters in July that he will put on a mask “when there is no corruption. Then I’ll put on a mask and I’ll stop talking”.

“As we would say to leaders all over the world: it is very important that behavior is modeled,” Ryan said on Monday. “If we’re advising people to do things then it is really important that political leaders and society influencers are in fact modeling those behaviors [themselves].”

As of the end of November, Mexico has seen more than 1 million cases and reported more than 100,000 deaths with COVID-19.

If politicians do not adhere to COVID prevention measures and restrictions, Ryan said, the basic prevention etiquette “becomes politicized [and] that helps nobody”.

The WHO stance, he added, is that when measures are implemented they require the support of everyone in government: “Everyone in a position of authority and influence [should be] is trying their best to model those behaviors in the best way they can.”

 

Image Credits: Nathan Rupert, Johns Hopkins University & Medicine, WHO.

Moderna’s mRNA research and innovation centre.

Moderna on Monday announced that it would immediately request emergency authorization today for its mRNA COVID-19 vaccine candidate from both the U.S. Food and Drug Administration (US FDA)  and the European Medicines Agency – as well as asking the World Health Organization for an emergency use listing. 

The announcement came in a week that will see movement towards the first approval of COVID vaccines anywhere in the world outside of Russia and China. The United Kingdom’s independent regulatory agency was set to review the Pfizer mRNA candidate this week and possibly approve it as  early as next Monday or Tuesday (7 or 8 December). 

US FDA approval for the Pfizer vaccine could come as early as 10 December, the day after the Moderna review is scheduled, followed by a 17 December FDA review – and likely approval – of the Pfizer candidate. 

The UK government also asked its Medicines and Healthcare Products Regulatory Agency, to evaluate AstraZeneca’s potential COVID-19 vaccine for an accelerated release of a temporary supply.  A letter from top officials at Britain’s National Health Service to NHS hospitals, already outlined plans for a staged rollout of vaccines to high-risk groups, saying that “latest advice indicates that the very earliest we will have the first vaccine approved is early December.”  

The AstraZeneca adenovirus vaccine candidate, developed in partnership with researchers at Oxford University, is the least expensive and easiest to manage of the three front-running options. The UK has also signed a supply agreement with AstraZeneca for 100 million doses of the vaccine, 4 million doses of which are anticipated to be delivered by the end of 2020 and 40 million by the end of March 2021. 

“We are working tirelessly to be in the best possible position to deploy a vaccine as soon as one is approved by the independent regulator, the MHRA,” said Matt Hancock, UK Health and Social Care Secretary. 

Stéphane Bancel, CEO of Moderna

Moderna Vaccine 100% Efficacious Against Severe COVID

In a press release by Moderna, the company announced that its vaccine had a 94.1% efficacy rate, in a just completed, primary efficacy analysis of results from 30,000 study participants in the USA. Significantly,  efficacy against severe COVID was 100%, the company said, and efficacy was consistent across age, race, ethnicity and gender demographics.

Release of today’s results, which updated an interim analysis reported earlier, found a total of 196 COVID-19 cases among Moderna’s 30,000 trial participants, of which 185 cases were in the placebo group, versus 11 in the group that received the vaccine.   All 30 severe cases, including one COVID-19 related death, occurred in the placebo group, the company reported. 

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” said Stéphane Bancel, Moderna Chief Executive Officer.

As a result, the company said in its press release that it is taking the following immediate steps: 

  • Moderna plans today to request Emergency Use Authorisation (EUA) from the U.S. FDA. The next step will be a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA-1273, which the FDA has told Moderna to expect on December 17, 2020
  • Moderna plans today to apply for a conditional marketing authorization with the European Medicines Agency (EMA)
  • Moderna intends to seek Prequalification (PQ) and/or Emergency Use Listing (EUL) with the World Health Organization (WHO)

The company also said that it would be submitting its results to a peer reviewed journal for publication. 

WHO Emergency Use Listing Or Prequalification? 

While Moderna so far has made no commitment to license its vaccine to other manufacturers, its move to apply for recognition of its vaccine with WHO could position the company to open the doors to generic vaccine production, in collaboration with global health agencies – if it chose. 

Currently, the Moderna vaccine carries an estimate US$ 25 per dose, for the two-dose regime, as compared to the AstraZeneca vaccine, which will cost only about US$ 3 per dose – for a two dose regime – placing it beyond the budgets of many countries in the world. 

Access to affordable vaccines has loomed as the dominant global health issue of 2021 as the world’s rich nations, along with a few low- and middle-income countries such as India, Mexico and Brazil have already bought up – or placed options on – a dominant proportion of available supplies from the first vaccines becoming available – outside of Russian and Chinese vaccines which have not yet released full details of their data. 

The Brazil-based Oswaldo Cruz Foundation (Fiocruz) signed an agreement with AstraZeneca to acquire and distribute its COVID-19 vaccine.

Globally and Nationally – Countries Watch To See Who Will Be First In Line  

As the pace of vaccine reviews and approvals picked up, so was the anticipation about timelines and logistics around vaccines rollout.   

In the United States, active preparations were already underway to facilitate distribution of the Pfizer/BioNTech vaccine, including test flights on American Airlines and United to check shipment processes for the vaccine, which needs to be stored at -70°C. 

Pfizer has two main facilities producing its COVID-19 vaccine, one in Michigan and the other in Puurs, Belgium to support European distribution. But late last week, US officials acknowledged that some Pfizer vaccines were in fact being moved from Europe to the United States – in anticipation of the earlier rollout in the latter.

“Operation Warp Speed leaders are aware of and facilitating vaccine shipments coming to the US from Belgium. In an effort to minimize the potential risk to delivery and distribution, we are unable to provide specific details regarding where vaccines are produced and stored,” said a statement from the US Department of Health and Human Services. 

An Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC), was to be convened Tuesday to decide which individuals will be prioritized to receive the vaccine once it is approved. “We foresee imminent authorization if this vaccine is shown to be effective and safe in the near future and we want to be at the point where we are providing appropriate guidance to the states and jurisdictions for the use of these vaccines,” said Jose Romero, ACIP chair. 

Canada and Switzerland May Wait Much Longer

But in neighboring Canada there was also disappointment over news that Canadians might not get access to the vaccine until later in 2021.  

In Switzerland, meanwhile, Moderna said it was ready to swing into action with vaccine production at the manufacturing facility of its partner Lonza in the country’s Valais region.  But that depends on the vaccine’s approval by the independent Swiss medicines Agency, Swiss Medic – which might only happen in early 2021, a Moderna spokesperson told Health Policy Watch.  

“There is no fixed timeline for the rolling review process,” said a Moderna spokesperson.  “Our best estimate is that the SwissMedic approval will be granted at the start of 2021… As you may also know, Switzerland was one of the first to  conclude an agreement for the procurement of 4.5 million vaccine doses. Therefore, vaccine delivery to Switzerland is dependent on the approval of the vaccine candidate by SwissMedic.”

He added that Switzerland is manufacturing Moderna’s vaccines “for all markets outside of the USA,” while for the US, there is another dedicated manufacturing and supply chain. 

While Moderna so far has made no commitment to license its vaccine to other manufacturers, the move to apply for recognition of its vaccine with WHO could also position the company to open the doors to more production in collaboration with global health agencies – if it chose.  However, for now, the Moderna vaccine carries a price tag of US$ 25 per dose, for the two-dose regime, as compared to the AstraZeneca vaccine, which will cost only about US$ 3 per dose – pricing the Moderna option out of the budgets of many countries. 

WHO – Vaccine Logistics Huge Challenge   

While access to COVID-19 vaccines looms as the defining global health issue of 2021 – it’s not only an issue of price, WHO experts pointed out at Monday’s press briefing.  While the world’s rich nations have bought up huge stocks of vaccines, a few low- and middle-income countries such as India, Mexico and Brazil, also are positioned to get earlier access to supplies – by virtue of their domestic manufacturing base.  

WHO’s Mariangela Simão blamed it on excessive global concentration of manufacturing. 

“We have seen the world not so much divided, not so much between high, low and middle income countries… but between countries that have manufacturing capacity – and there are low and middle-income countries that do have manufacturing capacity – and countries that do not have manufacturing capacity,” said Simão, who is Assistant Director General for Drug Access, Vaccines and Pharmaceuticals. There’s a need for government to reflect about the concentration that we have nowadays on the global supply chain of medicine and vaccines, and health products in general.

“I think it’s the time that when also when we think of the future, to really establish policies where we can have a more diversified supply chain that don’t risk shortages, not only for vaccines.  We are seeing for example some shortages of ICU medicines that we didn’t expect like injectable opioids.  The need for countries to think of development policies or infrastructure policies that actually enhance local production of health products is extremely important – and I think is one of the lessons learned from this pandemic. 

In the near-term, meanwhile,concerns being expressed even by rich countries like Canada about vaccine access, highlight the importance of making the WHO COVAX vaccine procurement facility work well – so that the highest risk groups around the world can get access to the first available vaccine supplies,regardless of their local manufacturing base, said WHO’s Katherine O’Brien, head of the department of vaccines, biological and immunologicals. 

Pan American Health Organization (PAHO) administering vaccines in Venezuela.

The COVAX facility, which is to serve 187 countries has so far raised US$ 2 billion this year.  But it remains US$ 5 billion short for 2021 to raise the funds sufficient to produce and distribute 2 billion vaccine doses, O’Brien noted, saying: “The ability to procure vaccines, on behalf of the facility is dependent on the funding that is available for procuring those vaccines.

“So I think we really do have to take….  the expectations and turn that on the global lens – that really, the scientifically and epidemiologically impactful thing to do is to have adequate supply in equal time, in equal measure around the world for every country to …be immunizing those populations that highest priority, and to move as quickly as possible through those priority groups onto those who have a lower risk of serious disease.”

Along with that, she said, the delivery infrastructure of vaccines is going to be the equivalent of “building base camp at Everest”, she added. “The competence in communities, the acceptance of vaccines, and assuring that people are in fact immunized with the right number of doses, with the products that are available, is what it’s going to take to scale to the peak of  the mountain. 

“And so as we anticipate that the year ahead for every country, it’s not only about assuring that there is supply, it’s also about a massive unprecedented scale of readiness and implementation of delivery and all that that will take in every community in every country around the world.”

News Hailed By Experts – WHO’s Dr Tedros Talks About Hope 

Dr Tedros Adhanom Ghebreyesus, WHO Dicrector General.

Despite the obstacles, news of the Moderna submission was greeted as a kind of watershed, with gleeful expressions of hope and delight even among normally sober scientists. 

“Moderna Covid vaccine has 94% efficacy, final results confirm. Looking forward to seeing the results published in scientific journals,” tweeted Didier Pittet, an infectious disease expert and director of the infectious control programme at the University Hospital of Geneva. 

“It’s a Monday in November which means a #COVID19 vaccine press release. Today’s is from @moderna_tx reporting data from its primary analysis and showing a 94.1% efficacy in the prevention of COVID-19 disease and 100% efficacy in preventing severe disease.  A game changer!” said Carlos del Rio, executive associate dean of Emory School of Medicine, in Atlanta Georgia. 

Said Director General, Dr Tedros Adhanom Ghebreyesus at the WHO press conference: “There is a lot of hope, especially with the advent of the vaccines that have been announced. In the last few weeks. And from the WHO side. We are sure that we can defeat this pandemic using the existing tools, and also the vaccines that are in the pipeline. The most important thing is we need to have hope. And not only hope. But solidarity, to work together to fight a common enemy, using the existing tools, and also the new announcements of vaccines, in the pipeline.”

–Madeleine Hoecklin contributed to this story.

Image Credits: Moderna, Ministério da Saúde , WHO/PAHO, WHO.

Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

In a politically charged series of exchanges at a Friday press briefing, World Health Organization officials pushed back against queries by a representative of China’s state-controlled CCTV, asking about whether the SARS-CoV2 virus discovered in Wuhan, China in December of 2019 could have been circulating in humans “outside of China before the outbreak in Wuhan, but without being noticed.” 

“One thing that has to be clear is the study will start from China, Wuhan, where the first report came,” said WHO Director General Dr Tedros Adhanom Ghebreyesus at the press briefing. “And then from there, based on the findings, we can go anywhere. So I think it’s better to really underline that.”

Mike Ryan, WHO Health Emergencies Executive Director, did not directly rule out the possibility that the virus could have been circulating somewhere else in the world among animal populations –  he said that the evidence of its first presence in humans led to China: 

“It is clear from a public health perspective that you start your investigation from the place where the cases first emerge,” said Ryan, recalling that Chinese clinicians had first picked up the cluster of acute pneumonia cases in the city of 10 million people. “There was a link to the market market and it triggered in their minds a suspicion, and they reported it to the authorities. 

Dr. Michael Ryan, WHO Executive Director of Health Emergencies

“So I think it’s highly speculative for us to say that the disease did not emerge in China. What we do know is the first clusters of human cases that were detected, were in Wuhan and China, there was a massive response to containing that disease there. And we look forward to working with our Chinese scientific colleagues to understand better the origins of the virus within China or beyond China, wherever that leads,” said Ryan. 

While an international WHO committee of experts mandated to investigate the big questions over the virus’s murky origins has now been named, and even held initial virtual meetings with colleagues in China – no date for any visit by the group to Wuhan, China has yet been set.  WHO insiders have said that securing Chinese cooperation for a genuine fact-finding mission has been an uphill battle, despite the pledges of cooperation that have been publicly made, and repeated. 

Speaking at Friday’s press conference, WHO officials deferred yet again from setting a date, affirming only that  the group will indeed visit Wuhan at some time in the future. 

“Yes, it’s correct, it will go to Wuhan, it will travel to Wuhan, thank you,” said Dr Tedros, briefly in response to another query by the Japan-based media outlet, NHK.

Wuhan, China

Patient ”Zero” and Geopolitics

The origins of the virus in China, while linked to a Wuhan market where wild animals were slaughtered and sold for traditional foods,has never been pinned down completely through the identification of a “patient zero” who was the first to become infected from an animal source. The virus is thought to have emerged among bats; coronaviruses circulate in bat populations in rural regions of the country.  Although there could have been other intermediary animals involved as well, including ones transported to the Wuhan market by traders. However, no clear animal to human transmission chain has so far been identified, and the heavy official Chinese government controls over research, travel and media have left many avenues closed to international sleuths.

And after months in which outgoing US President Donald Trump repeatedly blamed China for the pandemic’s emergence, constantly referring to SARS-COV2 as the “China virus”, the issue of the virus’s origins has become even more politically charged, with Chinese government officials and media hitting back with the circulation of theories suggesting that maybe the virus lept the animal-human barrier somewhere else, outside of China.

At the Friday briefing, WHO officials acknowledge that there is, in fact, evidence from Italian sewage and blood samples that human carriers of the virus may have been moving around the region, which has heavy business exchanges with China, as early as autumn, 2019.

Maria Van Kerkhove, WHO technical lead for the WHO Health Emergencies team, referred to a recent studies at Milan’s National Cancer Institute (INT), which found traces of the SARS-CoV2 virus RNA in some peoples’ blood samples as early as September. Another study found traces in sewage in  Milan and Turin. But insofar as the SARS-COV-2 family of viruses have never been reported to circulate in European animal populations prior to the pandemic, experts still conclude that any silent human carriers in Italy either brought the virus back with them from China – or were exposed to someone else who had traveled back and forth.

Bats are are reservoir for cornaviruses that circulate in nature

“There is one study that was published very recently, looking at serological samples from Italy, at a cancer screening institute in the fall, and they found serum positive samples in September,” Van Kerkhove said.  “We reached out to these reserachers and they have generously offered to work with us and to colaborate with us on some further studies looking at those samples.

“But as Mike has pointed out, the studies need to begin where the first cases were detected in Wuhan, where those first casese were detected in December,” she concluded.

At a World Health Assembly (WHA) meeting in May, WHO member states unanimously agreed to mandate a team of international experts to identify “the zoonotic source of the virus and the route of introduction to the human population”.  Following that, WHO sent an advance team to China in July to pave the way for a visit by the expert group, but progress on an actual visit stalled after that. 

Asked why at a media briefing on Monday, Kerkhove would say only that “the international team will travel to China”, and that it “is being discussed amongst the international team and the Chinese counterparts. And that will be arranged in due time”. 

An initial virtual meeting between the international and Chinese teams took place in October. Following that, WHO published outlines of  a Phase 1 and Phase 2 study for the virus origins investigation.  Just this week, WHO finally released the names of the experts who have been assigned to the delicate task of the virus hunt.

Peter Daszak, President of EcoHealth Alliance

They include prominent public health, animal health and virology experts from Australia, Denmark, Great Britain, Germany, Japan, Netherlands, Russia, Japan, Qatar, Viet Nam and the USA, including Marion Koopmans, who is leading research into the Dutch outbreak on mink farms and John Watson, former UK deputy chief medical officer. The team also includes Peter Daszak, a prominent British zoologist and researcher into bat coronaviruses in southeastern China, who is also president of the US Ecohealth Alliance. He holds the double hat as head of an independent Lancet’s COVID-19 Commission Task Force, which is also looking into the virus origins.    

At a November session of the WHA, Garrett Grigsby, deputy director of the US Department of Health and Human Services, charged that the investigation team’s terms of reference were “not negotiated in a transparent way with all WHO member states” and were inconsistent with the original WHA mandate, adding, “Understanding the origins of COVID-19 through a transparent and inclusive investigation is what must be done to meet the mandate.”

WHO officials have said that they are regularly consulting with the missions of other governments in Geneva, and that the study process and findings will be transmitted transparently.  Behind the scenes there is pressure on WHO to also push harder on the Chinese government – but whether this is out of deference to Beijing or a realistic assessment that it will not achieve anything, Dr Tedros and have team have resisted doing that. 

High Tech Freezer Solutions Could Make Even Pfizer Vaccine Feasible In Africa

Katherine O’Brien, Director WHO Vaccines, Immunizations and Biologicals

At the briefing, WHO officials also said that high-tech freezer solutions could make it feasible to even distribute COVID-19 vaccines like Pfizer’s mRNA candidate, which requires ultra-cold storage – at least in the central health facilities of developing countries. 

That could help ease the rollout of much-needed vaccines to vulnerable groups like health care workers, as soon as regulatory approval is obtained, said WHO’s Katherine O’Brien, speaking at the WHO press briefing. 

However, the experts also acknowledged that another up and coming vaccine, produced by AstraZeneca, and which can be preserved in normal refrigerator conditions, will be more practical for widespread rollout – if it wins approval soon. Their remarks echoed comments made earlier this week by WHO African regional officials. 

“We do have experience in a number of countries, specifically in Africa, being able to deploy a vaccine with that ultra cold chain requirement,” said O’Brien, referring to past experiences managing Ebola vaccines. 

“So as we anticipate the use of the Pfizer vaccine, the intention is certainly to be able to use it, along with other vaccines because no one vaccine is going to have adequate supply, nor will any one vaccine necessarily have suitable operational characteristics to meet all of the needs. 

O’Brien noted that Pfizer has already developed a special shipping container for its vaccine, that can maintain its stability for 101-15 days, and despite the overall ultra-cold requirement of -70 C, the vaccine can in fact be kept in a normal vaccine refrigerator for up to 5 days prior to its final use. 

Pfizer’s request for emergency use approval by the United States Food and Drug Administration will be reviewed on 10 December, and there is widespread expectation among US experts that the vaccine could even be approved the next day – making it the first to actually hit the market for distribution even before the end of the year.

However, along with that, WHO’s Dr Tedros stressed once more that urgent funds are still needed to finance the massive procurement of billions of vaccine doses for low- and middle-income countries that cannot afford to purchase the vaccines themselves – and particularly not at the high-end prices of US$ 25-US$ 30 per dose (for a two dose shot) that is likely to be the benchmark in Europe and the United States for the cutting edge mRNA vaccines developed by Pfizer and Moderna.   

In comparison, AstraZeneca’s vaccine, which relies upon a less expensive adenovirus delivery platform, long been used in vaccine development and manufacture, is to be sold at the no-profit levels of just US$ 3 dollars a dose – or about US$ 6 in total.   

-James Hacker contributed to this story. 

 

Image Credits: Arend Kuester/Flickr, R Santos/HP Watch, Wikipedia , Shutterstock .

The 2020 G20 Riyadh summit, November 2020.

We are kicking off our expanded new series of opinion pieces, with Ilona Kickbusch’s reflections on last week’s G-20 and the mission of COVID vaccine distribution – what she describes as the most “defining global challenge” of 2021.  We invite contributions from health policy leaders, influencers and practitioners who wish to speak out on issues of concern – from wherever you may be in the world.   

In his global “wake up call” UN Secretary General, Antonio Guterres called on the global community to move from international chaos to the construction of an international global community that is capable of meeting and solving tomorrow’s challenges.

It was clear early on in 2020 that the Group of 20 most industrialized nations (G20) could not contribute much to resolve the present pandemic challenge – let alone the future – given the decision of the US president to disregard the pandemic, fight the World Health Organization (WHO) and to obstruct multilateral solutions.  It was even clearer last weekend that the G20 has not helped move this agenda forward.

COVID-19 is global, but the response to this collective global threat is still largely national. Its global dimension is still dependent on contributions in the form of development aid (ODA) and fundraising efforts of various types. This is also insufficient. Global health financing needs a full reset.

Instead, the rhetoric of global health in the speeches by global leaders has included regular mention of global goods and abounded with reference to equitable access to vaccines. “We will spare no efforts” said the G20 declaration at the conclusion of last weekend’s leaders summit, “we recognize the role of extensive vaccination as a global public good.” But the G20 has not stepped up to the plate to enable the ambitious goal to distribute 2 billion doses of COVID-19 vaccines before the end of 2021.

COVID-19 Vaccines is Test Case – But No Signal In Right Direction

The paradigmatic test case of common goods for health will be the equitable and fair access to a COVID-19 vaccine; this may be the defining global challenge of 2021. The G20 did not face up to a serious discussion on how to define and finance common goods. For example, recent estimates call for about US$ 26 billion a year of investment in common goods for health over the next five years, a manageable amount at just 0.32 % of total global spending on health.

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

The G20 is not a pledging forum but a signal in the right direction might have helped. The European Commission called for US$ 4.5 billion at the G20 meeting to be invested by the end of 2020 in the WHO co-sponsored ACT Accelerator – a new global collaboration for procurement and delivery of COVID-19 tests, treatments, and vaccines everywhere. Germany – which holds the EU Council Presidency – had already contributed more than €500 million (US$ 592.65 million) to this effort.

So if each G20 member had committed to paying only US$250 million (in cash or kind), the approximately $US5 billion would be available. They have not. Instead a small group of rich countries representing 13% of the world’s population has bought up more than half of the future supply of leading COVID-19 vaccines.  In response, India and South Africa (members of G20) have sent a proposal to the WTO asking “that it allow countries to suspend the protection of certain kinds of intellectual property related to the prevention, containment and treatment of COVID-19.”

But much more serious than the lack of easily affordable action on the present crisis is the lack of foresight in relation to the future.

During the global financial crisis in 2008, the structural problems that contributed to the crisis were addressed, leading to changes in the financial regulatory architecture at national and regional level.

In the same way the G20 should have used the pandemic to address the major structural financing deficits of the global order – especially in relation to financing global common goods for health. Economic losses from the pandemic are currently estimated to exceed 4.9%–7.6% of global GDP (US$4–US$ 6 trillion), an amount that is 20 to 30 times greater than the estimated cost of investing in epidemic preparedness. COVID-19 has resulted in the deepest recession in decades as the International Monetary Fund and the OECD have calculated – it will probably have 4-fold the impact of the 2008 financial crisis.

No Global Revenue Raising Mechanism For Global Goods – Leaves Health Leaders Fundraising With Music Industry 

The G20 finance ministers should have addressed the fact that after 75 years there is still no reliable mechanism at a global level to raise revenues for global functions produced by the United Nations system. Yet even in the face of the largest pandemic in 100 years there is no political will to address the financing of global common goods for health – except to embark on yet another round of fundraising, one fancier than the next.

This political neglect has left key institutions like the WHO severely underfinanced. As millions die of COVID-19, it must create a new foundation and reach out to the global music industry to engage in fundraising for vaccine development and distribution as well as for the pandemic response in low- and middle-income countries.

This does not bode well for a future where the world will not only have to deal with pandemics, but also with antimicrobial resistance and the impacts of carbon emissions on air pollution and climate change.  Even generous countries – like the United Kingdom (who will preside over the G7 next year) are pulling back on their ODA commitments and have announced a cut to the UK’s foreign aid budget, which will be reduced from 2021 from 0.7% of gross national income to 0.5%, “saving” approximately £4 billion.

At the G20 it was obvious that the US would stall any move in the direction of a proposal that has even a whiff of WHO involvement linked to it –  outgoing President Donald Trump preferred to play golf rather than attend much of the conference proceedings.

In contrast the European Union has been particularly active in pushing funding for the COVAX facility, the global risk-sharing mechanism for pooled procurement and equitable distribution of possible COVID-19 vaccines. This must be recognized. But it too has not yet pushed for a longer-term blueprint for new financing mechanisms for global health.

Whether it’s a Digital Tax or Financial Transactions Tax Or Other Means – Paradigm Shift Still Needed 

A collective global problem typically requires a common response.  As outlined in a recent paper, this requires a paradigm change that would transform global health funding.

Rather than engage in declarations full of nice words, the joint meetings of the Health and Finance Ministers of the G20 should devise a financing framework that ensures a sustained source of revenue for global common goods for health. Possibly through a global or multinational taxation system or mix of national, global and regional taxation. A digital tax is frequently mentioned in this regard as well as taxing financial transactions. In the meantime, coordinated institutional mechanisms like COVAX should be supported to pool resources for common goods – such as vaccines – that are desperately needed.

Raising some US$ 25 billion a year for pandemic preparedness in a world whose GDP exceeds US$ 75 trillion would require a very minimal, and thus almost painless, level of taxation, making this a particularly feasible option.

But without political will it cannot be done. Not only must the heads of government come together and address this issue – in 2020 in both the G7 (chaired by UK) and G20 (chaired by Italy) – but also the many interest groups in global health covering a wide span of agendas and diseases must come together to address this larger issue of a new financing regime for common goods for health. The system that is build on ODA and philanthropy is broken and the sooner we address this issue the better. Because with a new financing paradigm the world will be more equitable and we will all be safer.

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Professor Ilona Kickbusch is the Founding Director of the Global Health Programme at the Graduate Institute of International and Development Studies in Geneva. She is a member of the Global Preparedness Monitoring Board and the WHO High-Level Independent Commission on NCDs and co-chair of Universal Health Coverage 2030. She has been involved in German G7 and G20 health-related activities, and the development of the German global health strategy.

Image Credits: G20, European Health Forum Gastein.