As Europe Moves to Improve Mental Health Services for Children, Experts Are Concerned About Men’s Mental State 21/03/2022 Kerry Cullinan Dr Hans Kluge Mental health practitioners worldwide are warning of a massive wave of pandemic-related mental health issues that many countries are ill-equipped to address. On Monday, the World Health Organization’s (WHO) Europe office and the government of Greece launched a new European programme to strengthen and improve the quality of mental health services for children and adolescents. WHO Europe Director Dr Hans Kluge told the launch that suicide was the leading cause of death in children and adolescents aged 10 to 19 living in low- and middle-income countries in the region and that over 4000 young people in this age group had killed themselves in 2015. 🔴Suicide is the leading cause of deathamong adolescents in low & middle income countries & 2nd in high income countries in the European Region Find guidance on how to approach child & adolescent #MentalHealth as a primary health care provider here👉 https://t.co/EUoragqO0q pic.twitter.com/AOvZRIY7HR — WHO/Europe (@WHO_Europe) March 21, 2022 “Ensuring that all children and adolescents in the region have access to quality mental health services is a moral imperative,” said Kluge, adding that this was as important as childhood vaccinations. The WHO Europe programme aims to work with member states to encourage them to share knowledge and expertise about how to boost the mental healthcare of children and adolescents, and to support member countries to develop their own strategies and frameworks. It will also “develop a package of tools to measure progress against evidence-based standards”, according to the regional office. Through this new programme, WHO/Europe will continue to help countries strengthen and improve #mentalhealth services for children and adolescents, as well as developing tools to measure progress pic.twitter.com/Fspx9hh2lN — WHO/Europe (@WHO_Europe) March 21, 2022 Mental health woes of COVID-19 COVID-19 has exacerbated mental health issues and, during the first year of the pandemic, there was a 25% increase in the global prevalence of anxiety and depression, according to a WHO brief published in early March. Approximately 140,000 children in the US have lost a parent or guardian to COVID, for example, and are likely to be struggling to come to terms with this loss. “One major explanation for the increase is the unprecedented stress caused by the social isolation resulting from the pandemic. Linked to this were constraints on people’s ability to work, seek support from loved ones and engage in their communities,” according to the WHO. “Loneliness, fear of infection, suffering and death for oneself and for loved ones, grief after bereavement and financial worries have also all been cited as stressors leading to anxiety and depression. Among health workers, exhaustion has been a major trigger for suicidal thinking,” it added. Calls to South Africa’s only mental health helpline, for example, have jumped exponentially during the pandemic – from around 400 to 600 calls a day before COVID-19 to over 2400 calls a day in 2021. Psychologist Zamo Mbele, a board member of the South African Depression and Anxiety Group (SADAG) that operates the helpline, said that his non-governmental organisation, which is wholly reliant on donations, had been struggling to keep up with demand. Psychologist Zamo Mbele, a board member of the South African Depression and Anxiety Group (SADAG) Male violence and mental health “One of the reasons we’ve seen an increase in our calls is because of COVID, but one of the other reasons is because people who would not previously access health are beginning to recognise that they need help,” said Mbele. He added that “toxic” manifestations of masculinity – seen in the country’s high levels of domestic violence, road rage and substance abuse – were indications that men, in particular, needed help. “It’s not as though men only recently starting to struggle with mental difficulties or emotional difficulties,” he added. “But they are just starting to see that the expression of their difficulties is no longer functional to them or to society. It’s no longer as socially acceptable to be violent in order to deal with your depression, or to have a big temper in order to deal irritability or anxiety – or to drink excessively or to spend copious amounts of hours at the gym. “Instead, we’re beginning to recognise that actually doing a lot of these things is masking a lot of symptoms.” https://twitter.com/SkosanaDr/status/1505834397391544323 Men and suicide In the vast majority of countries, men are far more likely to commit suicide than women, which mental health practitioners say is likely to be because men find it harder to ask for help. This is a worldwide trend, captured by the WHO’s Suicide Worldwide in 2019: Global Health Estimates. The report found that South Africa has the third-highest suicide rate on the African continent. Of the 13,774 suicides reported in South Africa, 10,681 were men in 2913 were women. Russia, South Korea, the US and Japan also have high suicide rates, particularly amongst men. However, while there has been an increase in suicidal thoughts during the pandemic, there has not been a global increase in actual suicides – with notable exceptions, such as Austria, and Japan (although there is very little information from LMICs). Mass Polio Vaccination Drive to Administer More Than 80 Million Doses to Southern African Children in Five Countries 18/03/2022 Raisa Santos Polio vaccinate campaign to target children under 5 across five southern African countries. Malawi is launching a mass vaccination campaign against wild poliovirus type 1, which is to extend to 23 million children across five southern African countries, WHO said on Friday. The campaign, to kick off Sunday, follows Malawi’s declaration of a polio outbreak on 17 February – three months after the first polio virus case in 30 years was identified in a young child in Lilongwe. The case was the first in Africa since the region was certified free of indigenous wild poliovirus in 2020. WHO said that the region’s certification as wild polio-free remains unchanged, as the wild poliovirus strain identified had been “imported” from Pakistan. So far, no clear explanation of how the Asian virus strain may have infected an African child who had never traveled outside of the country, has been provided by WHO or Malawi health authorities. Nor has there been any explanation of why it took three months between the time the child was diagnosed and the outbreak was formally declared by WHO. But the breadth of the new campaign makes it clear the incident has been perceived as a major threat to Africa’s wild polio virus free status – with risks of subtle, silent transmission of the virus much more widely, via contaminated water and sewage, food, or human-to-human contact. Malawi has since set up an environmental surveillance system for poliovirus in 11 cities across four sites, including the Lilongwe District that encompasses the capital Lilongwe, where the initial, and so far only reported case, was detected, WHO said. Asked by Health Policy Watch whether traces of the wild polio virus had also been identified in sewage sources, through the environmental surveillance, WHO did not reply as of publication time. Targeting children across four countries – then Zimbabwe More than 80 million doses will be administered to more than 23 million children under 5 years in a four-round vaccination campaign in five southern African countries, WHO said. The first phase of the campaign, beginning this month, will target 9.4 million children across Malawi, Mozambique, Tanzania, and Zambia. Three subsequent rounds – with Zimbabwe joining the campaign- are set for April, June, and July, and aim to reach more than 23 million children with more than 80 million doses of the bivalent Oral Polio Vaccine recommended by the World Health Organization (WHO). “Polio is a highly infectious and an untreatable disease that can result in permanent paralysis. In support of Malawi and its neighbours, we are acting fast to halt this outbreak and extinguish the threat through effective vaccinations,” said WHO Regional Director for Africa Dr Matshidiso Moeti. “The African region has already defeated wild poliovirus due to a monumental effort by countries. We have the know-how and are tirelessly working to ensure that every child lives and thrives in a continent free of polio.” Single case of polio in Malawi linked to Pakistan strain Pakistan is one of two countries where polio remains endemic. Laboratory analysis has linked the strain detected in Malawi to the one circulating in Pakistan’s Sindh Province in 2019. In addition to environmental surveillance, WHO has also been supporting the country to reinforce response measures including risk assessment, and preparations for the vaccination campaigns. A surge team from WHO is working with country-based counterparts, partner organizations, and the government to end the outbreak. The WHO team is a part of a broader multi-partner Global Polio Eradication Initiative to support the country. In an unrelated event, a vaccine-directed case of polio was also identified in February by Israeli authorities in Jerusalem, also for the first time in 30 years. The infected child is part of an ultra-orthodox Jewish community in which vaccination rates hover at around 50% or less. A vaccination drive also was launched in the city. Polio, a viral disease with no cure, can invade the nervous system and can cause total paralysis within hours, particular among children under 5 years. The virus is transmitted from person to person, mainly through contamination by fecal matter or, less frequently, through contaminated water or food, and multiplies in the intestine. While there is no cure for polio, the disease can be prevented through administration of a vaccine. Image Credits: Sanofi Pastuer/Flickr, Sanofi Pastuer/Flickr. UN Environment Programme Joins WHO Alliance to Advance One Health Approach 18/03/2022 Editorial team Safer and more sustainable food systems – from production to sales in food markets is key to a One-Health Approach. UN Environment has joined a three-way alliance with the Food and Agriculture Organization, the World Animal Health Organization (OIE), and WHO to advance “One-Health” solutions to both ecosystem degradation and pandemic threats, leaders of the four agencies said on Friday. The statement followed a meeting this week of the Tripartite FAO, WHO and OIE partnership – which now has become a “Quadripartite”. “The One Health approach aims to sustainably balance and optimize the health of people, animals, ecosystems and the wider environment,” said WHO in a press release. “It mobilizes multiple sectors, disciplines and communities to work together to foster well-being and tackle threats to health and ecosystems. And it addresses the collective need for clean water, energy and air, safe and nutritious food, action on climate change, and contributing to sustainable development.” The work of the newly expanded alliance will be focused on a One Health Joint Plan of Action, which includes six main action tracks: enhancing countries’ capacity to strengthen health systems under a One Health approach; reducing the risks from emerging or resurfacing zoonotic epidemics and pandemics; controlling and eliminating endemic zoonotic, neglected tropical or vector-borne diseases; strengthening the assessment, management and communication of food safety risks; curbing the silent pandemic of antimicrobial resistance (AMR) and better integrating the environment into the One Health approach. Increased awareness of One Health As the world enters the third year of the COVID-19 pandemic, with an estimated cost of $8 to 16 trillion, there is increased awareness and broad recognition of the importance of One Health as a long-term, viable and sustainable approach. The G7, G20 and UN Food Systems Summit have all given a nod to the approach, along with the increased references by WHO and its partners. But the hard work of reforming food systems, from production to markets, as well as halting related deforestation and ecosystem destruction, are much more formidable challenges that the organisations have barely begun to face. Last year saw the Tripartite implement a number of initial initiatives, including on antimicrobial resistance, a One Health High-Level Expert Panel, and guidance on better management – but not the banning – of wild animal sales in markets – in the wake of the COVID pandemic, whose origins may have emerged from the capture, transport and slaughter of SARS-CoV2 infected wild animals at the Wuhan, China market. Plan implementation the key challenge “Now the challenge is implementation: how do we translate our work on the ground to support our Members? And how do we mobilize funding and financing mechanisms to support the Joint Plan for Action?” said FAO Director QU Dongyu, handing over the chair of the Secretariat to WHO. WHO Director-General Tedros Adhanom Ghebreyesus, said: “We need to build a more comprehensive and coordinated One Health governance structure at global level. We need a strong workforce, committed political will, and sustained financial investment. We need to develop a more proactive way of communicating and engaging across sectors, disciplines and communities to elicit the change we need.” (WHO) Image Credits: Michael Casmir/Pierce Mill Media. Healthy Mouths, Healthy Planet 18/03/2022 Ihsane Ben Yahya, Nicolas Martin & Steven Mulligan Dental procedures produce a hefty amount of carbon emissions. In honour of World Oral Health Day, 20 March, three leading voices from the World Dental Federation highlight the unexpected linkages between the health of your mouth and that of the planet. It will come as a surprise to most people that the healthcare sector has a significant environmental impact. Healthcare systems are responsible for around 5% of global greenhouse gas emissions, of which oral healthcare is an important contributor. Indeed, if the healthcare sector was a country, it would be the fifth largest greenhouse gas emitter on the planet. Oral healthcare contributes to this environmental burden with air pollution arising from the release of CO2 associated with travel and transport, the incineration of waste, the greenhouse gas impact of anesthetic gases such as nitrous oxide and the high consumption of water. Specific to dentistry, the most routine procedures, all come with a hefty carbon price tag. Tooth-coloured fillings for instance, produce around 15 kilograms of CO2eq (carbon dioxide equivalent) per procedure, according to Public Health England, whose National Health Service has done some of the most extensive carbon footprint modeling of healthcare delivery in the world. A single root canal treatment, meanwhile, produces 23 kilograms of CO2eq, dentures between 58 and 71 kilograms CO2eq. Use of the anesthetic gas nitrous oxide (laughing gas), in a procedure, meanwhile, is responsible for 119 kilograms CO2eq. Nitrous oxide N2O, the most commonly used inhalation dental anesthetic, is a greenhouse gas with far more climate warming potential than CO2. Just one kilogram of nitrous oxide is equivalent to 298 kilogrammes of CO2 and 25 kilograms of methane – another powerful greenhouse gas. Meanwhile, silver amalgam fillings contain mercury. While more and more rarely used today, and still considered safe for dental treatments, there is an environmental impact through the release of residual mercury into sewage during procedures, as well as throughout its life cycle. Prevention is better than cure Ways to maintain good oral health. The dental industry has a collective responsibility to reduce these impacts – while also expanding access to oral healthcare. How can we do both? One simple solution is to look at how we can best minimize what we might label as “avoidable” oral procedures. Prevention is always better than cure and it is the most impactful and practical way of reducing the need for clinical interventions and their associated environmental impacts. This is best achieved through the promotion of good oral hygiene, a healthy diet and the avoidance of smoking. When treatment is required, oral healthcare also should focus on the provision of durable fillings, using high quality products and materials that will last longer and/or require fewer replacements. Legislation around water fluoridation for instance, complemented by targeted public health policies can help prevent tooth decay (caries) and ultimately cavities. The recent banning of TV and online advertising of junk food in the UK before 9pm is an indirect example of encouraging better diet. So too the campaign by UK footballer Marcus Rashford to promote healthier school lunches. At the same time, while many dental problems such as caries and periodontal (gum) disease are common preventable diseases, no amount of prevention can make them go away entirely. There will always be a need for accessible dental check-ups and treatments to facilitate good oral health. And it remains important to expand access to such treatments among disadvantaged groups as well as in many low- and middle-income countries so as to reduce inequalities in healthcare provision. Less trips to the dentist would also mean less travel and water consumption Dental procedures require a lot of water, which can be reduced by practicing good oral healthcare. Oral healthcare has higher levels of patient and staff transport than other medical specializations and this is partly due to the need for regular oral health maintenance, whereas other specializations tend only to treat illness. In the UK for instance, staff and patient commuting and travel accounts for approximately two thirds of all emissions from the oral healthcare sector and about eight per cent of the total UK NHS air pollution attributable to travel. This can be reduced significantly, through the maintenance of good oral health, that requires fewer interventions and consequently fewer trips to the dentist. Simple transport habit changes can have a great impact. For example, in October 2021 the Sustainability Committee at Harvard School of Dental Medicine (HSDM) implemented a `Step Challenge´ that encouraged staff, students and faculty to walk, or take public transport rather than drive during that month. They amassed over one million steps in total, preventing the release of approximately 0.28 metric tons of CO2. The practice of dentistry and personal oral healthcare is a significant consumer of water. As a conservative estimate, a bathroom tap delivers about four litres/minute. If we estimate that half the world population cleans their teeth once a day and runs the tap for one minute, the daily global water usage equates to 6,400 Olympic swimming pools. This figure is in addition to undocumented water consumption up and down the oral healthcare manufacturing and distribution supply chain. Reducing dental use of single use plastics and packaging Measures to reduce carbon footprint in dental offices. So what measures can be taken at the dentist office to reduce the carbon footprint of dentistry procedures that are nonetheless essential to good oral health? The use and consequent disposal of single use plastics for many procedures is one of the biggest contributors to the environmental footprint of healthcare generally – and that holds true for dentistry as well. Among single-use plastics, in fact it is the packaging in which the needles, gloves and other oral healthcare products are encased that is the single largest contributor to such waste in the dental industry, with over 90 % ending its life cycle in an incinerator or a landfill. A more thoughtful approach to the design of such packaging – from the plastics content, manufacture and transport, to the potential for reuse, recycling or biodegradability, is therefore one obvious starting point in reducing the carbon footprint of the typical dentist’s office. This is particularly important because packaging, as such, is not “contaminated” biomedical waste that needs special treatment, post-procedure. This requires greater engagement with consumers and waste management companies to segregate, collect and recycle uncontaminated clinical single use plastics (SUPs) as a valuable commodity. It also involves the design and development of more plastic items made from mono-polymer plastics that can be readily recycled. The Flexible Plastics Consortium which represents 34 European companies looking for better plastics content and design solutions for packaging is a good example of how this might work in practice. The United Kingdom’s Plastics Pact is another good example: it has set targets with the goal of 100% of plastic packaging to be reused, recycled or compostable by 2025. Major challenges in managing single use plastic waste from oral healthcare Many single use dental items end up in the waste bin, including gloves, aprons, masks. Once the box is opened, many of the everyday products used in dentistry are only briefly used and then end up in the waste bin. These single-use plastic (SUP) items range from personal protective equipment (aprons, gloves and masks) and other disposable sundries (the mouth-rinse cup or the dental suction tube). SUP biomedical waste requires more specialized management – since these are contaminated with blood and other bodily fluids from oral health procedures. The high safety and quality requirements for these products to be legally compliant, is often incompatible with recycling and materials recovery. The complex nature of items assembled from different plastics also makes recycling difficult, as does the prevailing view that plastic is simply waste and is not considered a valuable resource. Still there are many attempts at finding solutions around the world. These include incentivization schemes and professional education courses that can help manufacturers to design products that can be safely treated and reprocessed, as well as sensitizing dental practitioners to different waste streams, and the treatment they require. Initiatives like the development of a competency-based dental waste management course being undertaken at the Copperbelt University in Zambia are a step in the right direction. Even so, the lack of good technological solutions for the appropriate collection, disinfection/sterilization and subsequent recovery or reprocessing of single use plastics used in biomedical procedures remains an ongoing barrier. We need product research to come up with safe, sustainable solutions for a circular economy, including in the healthcare sector, and governments to adopt supportive policies. Assessing the environmental impacts of oral healthcare as a first step It is important to understand the environmental impacts of materials used in healthcare. A better understanding of the environmental impacts of products and materials used in healthcare systems, from procurement to disposal, is key to any of these measures. Solutions proposed have included more life cycle analysis for all materials used in the healthcare supply chain and the development of a credible ‘sustainability index’ to inform medical supply purchasers about the sustainability credentials of a product. The index could potentially include information on environmental sourcing, ethical manufacturing, supply chain distribution and procurement. This World Oral Health Day we can celebrate the fact that the oral health sector has recognised that it has a vital role to play in healthcare-related climate change mitigation. That is the first step. The next ones will be more challenging and will need ‘teeth’. The FDI World Dental Federation´s Code of Good Practice, which is to be launched later this year, following an extensive consultation with the sector, will be a good starting point for ensuring healthy mouths also help to produce a healthier planet. Steven Mulligan Nicolas Martin Ihsane Ben Yahya Ihsane Ben Yahya is the President of the FDI World Dental Federation and professor at the Dental University in Casablanca, Morocco. Nicolas Martin is the Chair of the FDI Sustainability in Dentistry Task Team. He is also Clinical Professor in Restorative Dentistry in the School of Clinical Dentistry, at the University of Sheffield, UK. Steven Mulligan is a Member of the FDI Sustainability in Dentistry Task Team. He is also a Clinical Lecturer in Restorative Dentistry in the School of Clinical Dentistry, at the University of Sheffield, UK. Image Credits: Mass Communication Specialist Seaman Apprentice Brian H. Abel/Flickr, FDI World Dental Federation , Jan Fidler/Flickr, World Dental Federation , Mass Communication Specialist 3rd Class Everett Allen/Flickr. From COVID to Humanitarian Crises – Medical Oxygen Needs More Prioritization for its Lifesaving Capacities 17/03/2022 Raisa Santos Lifesaving oxygen flows into the lungs of a COVID patient in Chernivtsi, southwest Ukraine before the start of the recent Russian invasion. Whether its due to COVID or conflict, oxygen supplies fall short in many parts of the world. From patients lying in the parking lots of hospitals, in the back seats of cars suffocating as their family members searched frantically for oxygen in India during its second wave of COVID last year, to the inability to receive emergency care amidst constant bombing and shelling in current war-torn Ukraine, global health experts and leaders are desperately searching for ways of improving the global oxygen supply. At a media briefing on the issue Thursday, speakers emphasized the need for both access to oxygen on the ground and more funding to the WHO co-sponsored Access to COVID-19 Tools Accelerator (ACT-A), which is attempting to beef up oxygen supplies in low and middle-income countries. “Oxygen has been treated for too long like a commodity, treated as something that must be delivered,” said WHO Executive Director of Health Emergencies Programme Dr Mike Ryan, speaking at the briefing, cosponsored by the Act Acccelerator and Unitaid. But “oxygen is a capability, not a commodity,” he stressed. Rethinking oxygen’s lifesaving capacities Mike Ryan, Executive Director, Health Emergencies Programme; World Health Organization Ryan and others made the case for rethinking oxygen as a health tool that requires not only a sustainable supply at a country level, but an entire ecosystem of supply and maintenance technology and infrastructure. Its role – and the chronic lack of capacity in many countries – has been underscored by COVID – and again in the very different setting of the Ukraine crisis – where the lack of access for people ranging from COVID patients to mothers in birth and children with pneumonia has prompted widespread alarm. Oxygen remains a critical component of the global COVID-19 response – 75% of patients hospitalized for COVID-19 can be treated with oxygen alone – without any further advanced care. Yet the current global supply of oxygen does not meet needs for both COVID-19 and other serious illnesses. “COVID didn’t cause [the oxygen shortage], COVID uncovered this. COVID laid bare, tore away the bandages from some very old wounds,” said Ryan. UNITAID Commits $56 million to boost access to global medical oxygen supply Robert Matiru, Chair, ACT-A Oxygen Emergency Taskforce & Director Programmes, Unitaid The ACT-A Strategic Plan and Budget for 2022 has identified a funding deficit of $1 billion for oxygen supplies worldwide for this year alone. As a first step to closing that gap, Unitaid has announced that it will invest $56 million to increase access to medical oxygen both for short-term needs related to COVID-19 as well as for the longer term – as a critical foundation for fighting future pandemics. The Unitaid pledge builds on the $50 million USAID has committed in funding for oxygen as pledged at US President Joe Biden’s Global COVID-19 Summit in September 2021. Four Unitaid-funded projects, designed to address global inequities in oxygen access, will be implemented by The Alliance for International Medical Action (ALIMA), the Clinton Health Access Initiative (CHAI), Partners in Health (PIH), and the WHO Health Emergencies Programme. These will also support the work of the ACT-A Oxygen Emergency Task Force by ensuring access to more affordable oxygen solutions such as bulk liquid oxygen, oxygen generation systems, and other important oxygen equipment. Unitaid called on donors, including governments, foundations, and private sector partners to join in the efforts. “Our call here is not just for the present, for this pandemic, but to recognize that donors and funders that come forward and step forward, over and above the generous contributors to date, will help drive a more sustainable ecosystem and [deliver] essential medicines to countries that are lacking it,” said Robert Matiru, Chair of the ACT-A Oxygen Emergency Taskforce and Director of Programmes at Unitaid. Children with pneumonia unrecognized victims – 40% of hospitals in some African countries lack oxygen Numerous countries are facing oxygen shortages, while readily available oxygen products are in short supply. Children are among the unrecognized victims of the lack of oxygen supplies – with childhood pneumonia still one of the biggest killers of under-fives. Accounting for almost a million deaths a year, the highest burden is in sub-Saharan African and South-East Asian countries where children face a double whammy of disease from both the lack of preventive treatments, like vaccinations, along with exposure to heavy indoor air pollution from the open burning of coal, biomass and other such fuels. But an estimated 20 to 40% of these deaths are preventable with increased availability of oxygen therapy. The shortage is particularly acute in low-income sub-Saharan African countries such as Tanzania, Sierra Leone, Liberia, and Gambia, where 40% of health facilities had no access to oxygen and other basic life saving supplies, said Atul Gawande of the United States Agency for International Development (USAID). COVID has led to big surges in needs Daily medical oxygen need for COVID-19 as of 16 March 2022 Along with the chronic shortages, COVID led to a major surge in oxygen needs. Low and middle-income countries (LMICs) need at least 23 million cubic meters of oxygen every day, just to treat COVID patients alone, according to the PATH COVID-19 Oxygen Needs Tracker. On the brighter side, the pandemic has brought a long-ignored aspect of health capacity in LMICs more to the forefront. USAID is currently working in 11 countries to build ‘oxygen ecosystems’ to support oxygen therapy for pneumonia patients, COVID patients, and others, Gawande said. Countries like Ghana now have oxygen generating capacity that can support up to 300,000 patients per day, per year. Gawande noted that the oxygen ecosystem includes liquid oxygen cylinders and concentrators, as well as the clinical engineering and technical assistance to use the technology. But expanding this initiative to other countries still needs more funding. Atul Gawande, USAID “As the Omicron variant abates, I think we’re all starting to feel that we can catch our breath. Oxygen demand may be lower right now. But it is the time that we have to make these investments to enable this kind of [sustainable] capacity.” Gawande said. Oxygen ‘natural security’ and ‘high-return’ health investment Leith Greenslade, Founder/CEO, JustActions & Coordinator, Every Breath Counts Coalition While the recent funding commitments are a positive sign, ‘it is not enough to fund protection’, said Leith Greenslade of the Every Breath Counts Coalition. “It took a pandemic of respiratory infection to wake up the world,” she pointed out. In the past year, about $700 million was invested into the ACT-A Oxygen Emergency Task Force, which has worked in LMICs to prevent oxygen shortages – jump-starting a more focused response. But so far, only a handful of governments – including the United States, Germany, Canada, and France – have borne the funding burden. “But most of the G-20 nations have not stepped up to invest in oxygen,” she charged. Greenslade appealed to donors to see oxygen as a high priority for three reasons: the moral obligation to flatten the COVID-19 curve; oxygen as a “national security” issue in moments of crisis; and finally, oxygen as a high-return health investment that will keep on saving lives beyond the pandemic. “When hospitals run out of oxygen, we have seen strikes and civil unrest in quite a few low- and middle-income countries,” she pointed out. “How many more deaths before this is over will largely depend on access to oxygen and critical care in the countries where the disease is greatest and the health systems are weakest,” she declared. Image Credits: Mstyslav Chernov/ Wikimedia Commons, UNICEF/Ralaivita, PATH, Every Breath Counts . Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates 17/03/2022 Elaine Ruth Fletcher Pfizer’s Paxlovid, an oral antiviral approved by the US FDA in December, has shown 90% efficacy in preventing mortality among those who take it in the first few days of infection. A Medicines Patent Pool (MPP) announcement Thursday that it has signed agreements with 35 companies to manufacture generic versions of Pfizer’s life-saving COVID-19 Paxlovid treatment for distribution in 95 low- and middle-income countries came fire almost immediately from medicines access groups as too little, too late. The MPP-brokered sublicences follow on from an agreement between MPP and Pfizer in November 2021 to supply generic versions of Pfizer patented main drug ingredient, nirmatrelvir, at cost, to countries that represent about 53% of the world’s population. However, activists quickly slammed with the new accord – saying that it would take up many months to actually set up the generic production lines of the game-changing oral drug, which in clinical trials, reduced COVID mortality by 90% among high risk groups. Mapping of the MPP-brokered licenses awarded for manufacture of a generic version of Paxlovid In a joint letter to Pfizer CEO Albert Bourla, delivered Wednesday, a consortium of 100 activist groups, including Amnesty International and Oxfam, said that Pfizer should immediately dedicate two-thirds of the company’s available patented drug supply to low- and middle-income countries, “where there is a proportionate need.” “At present, Pfizer has preferentially sold all of its Paxlovid doses from the first half of 2022 to a handful of high-income countries, and has tentatively promised to supply only 10 million courses of treatment of LMICs,” stated the Health Global Access Project (Health Gap), one of the signatories to Wednesday’s letter, in a follow-up blog posted online just after the MPP announcement. The activists also have slammed the still high price of the new drug in upper-middle and high income countries, saying that this also creates barriers to access. The United States is paying about $530 a day for a five-day course, although Pfizer has committed to a 3-tiered pricing system with lower costs to less affluent countries. “This announcement will do nothing to eliminate the monopoly Pfizer maintains over unlicensed countries – all high-income and almost all upper-middle income countries, representing 47% of the world’s population and historically experiencing the highest rates of COVID-19 infection,” added Brook Baker, Health Gap Senior Policy Analyst and a Professor at Northeastern University School of Law. MSF – A ‘positive step’ forward Médecins Sans Frontières sounded a more positive note, however, saying that the Pfizer agreement with 35 generics manufacturers in 12 countries represents a “positive step toward addressing the ongoing access challenges for this COVID treatment. However, the limitations of the deal remain concerning.” “The limited global supply from the US corporation Pfizer has so far largely been bought up by a number of high-income countries. It is estimated that generic manufacturers will not be able to bring supply to the market until 2023,” stated MSF. Replying to the criticism, an MPP spokesperson stressed that the new agreement “includes all low and lower-middle-income countries as well as some upper-middle income countries in Sub-Saharan Africa that have transitioned to upper-middle-income status in the past five years. The 53% of the world’s population covered by the licenses, “which is equivalent to about 4.1 billion people. As with all our licences we will continue to explore opportunities to broaden geographic scope, where possible,” the MPP spokesperson added. Design of MPP agreement According to MPP, the non-exclusive sublicence deals will allow generic manufacturers to produce the raw ingredients for Paxlovid’s main active ingredient, nirmatrelvir, and/or the finished drug itself, which is co-packaged with a common HIV drug, ritonavir. It said that six companies will focus on producing the drug substance, nine companies will produce the finished drug product and the remainder will do both. The manufacturers are based in 12 countries including: Bangladesh, Brazil, China, Dominican Republic, Jordan, India, Israel, Mexico, Pakistan, Serbia, Republic of Korea, and Vietnam. “A licence has also been offered to a company in Ukraine, the offer will remain available to them as they are not able to sign due to the current conflict,” MPP said. The deal signed between MPP and Pfizer in November 2021 established the terms and conditions, for the generic licenses, MPP added. Following that, “The requests for sublicences from generic producers were reviewed by MPP and presented to Pfizer,” for its approval – one of the conditions of the sale. Pfizer will not receive royalties from sales of nirmatrelvir from the MPP-negotiated sublicensees for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization, MPP added. Following the pandemic period, sales to low-income countries will remain royalty free, lower-middle-income countries and upper-middle-income countries will be subject to a 5% royalty for sales to the public sector and a 10% royalty for sales to the private sector. “Nirmatrelvir is a new product and requires substantial manufacturing capabilities to produce, and we have been very impressed with the quality of manufacturing demonstrated by these companies,” said Charles Gore, MPP Executive Director. “Furthermore, 15 companies are signing their first licence with MPP, and we warmly welcome our new generic manufacturing partners.” “We have established a comprehensive strategy in partnership with worldwide governments, international global health leaders and global manufacturers to help ensure access to our oral COVID-19 treatment for patients in need around the world, said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “The MPP sublicensees and the additional capacity for COVID-19 treatment they will supply will play a critical role to help ensure that people everywhere, particularly those living in the poorest parts of the world, have equitable access to an oral treatment option against COVID-19.” Image Credits: Pfizer , Medicines Patent Pool . Fourth COVID Vaccine Jab Provides Little Extra Protection to Healthy Individuals – NEJM 16/03/2022 Maayan Hoffman A month after a fourth dose of the Pfizer or Moderna vaccines was administered to hundreds of people in an Israeli clinical trial, authors of the new study on the extra booster say it provides “little protection, if any, from infection by COVID-19 among vaccinated young and healthy individuals in comparison to those vaccinated with only a third dose.” Result of the open-label study, conducted at Israel’s Sheba Medical Center, were published Wednesday evening in the New England Journal of Medicine as a correspondence. The findings contradict statements made by Pfizer CEO Albert Bourla over the weekend that a fourth booster dose could necessary for most people, due to waning immunity. Bourla made the statement as Pfizer seeks quick US Food and Drug Administration approval of a fourth dose, effectively a second booster, for people 65 and older. The new Sheba study included approximately 600 volunteers, among them 270 who received a fourth shot of either the Moderna or Pfizer vaccine. All of the volunteers had received three shots of the Pfizer vaccine prior to the trial. Sheba’s Professor Gili Regev-Yochay, lead author of the study, said in a statement that COVID infection rates among four-time vaccinated individuals were only slightly lower than those in the control group. However, she added that the fourth jab did provide moderate protection against symptomatic infection among young and healthy individuals, in comparison to those who had only received three jabs. “We found no differences, both in terms of IgG antibody levels and in terms of neutralizing antibody levels,” added Regev-Yochay, referring to the impact of the fourth jab on the study group in comparison to the control. “It should be emphasized that the third dose is extremely important for anyone who has not yet contracted COVID-19,” Regev-Yochay stressed, “and the fourth dose is most likely important for populations with risk factors, for which a fourth vaccine would protect from serious illness.” The NEJM correspondence, however, said that the fourth dose was “immunogenic, safe and somewhat efficacious”, adding that “our results suggest that maximal immunogenicity of mRNA vaccines is achieved after three doses and that antibody levels can be restored by a fourth dose.” The researchers added that they observed “low vaccine efficacy against infections in health care workers, as well as relatively high viral loads suggesting that those who were infected were infectious.” Bourla: Fourth shot ‘necessary’ The release of the data comes at an awkward time for Pfizer, after a weekend when Bourla said in an interview with CBS’s Face the Nation that a fourth COVID-19 shot would be “necessary” for most people to prevent future infection. Pfizer CEO Albert Bourla in a CBS interview on March 13, 2022. “Right now, the way that we have seen, it is necessary, a fourth booster right now,” Bourla said in the interview. “The protection that you are getting from the third, it is good enough, actually quite good for hospitalizations and deaths. It’s not that good against infections, but doesn’t last very long.” While Bourla said Pfizer had submitted data on the efficacy of the fourth shot to the US FDA, the data has not yet been publicly released. 1. A fourth dose of the Covid-19 vaccine is necessary for most people due to waning immunity, said Pfizer CEO Albert Bourla. He noted that the regimen of two doses plus a booster is not able to offer sufficient protection against new variants. pic.twitter.com/XPCFwiqluD — BFM News (@NewsBFM) March 14, 2022 The US Centers for Disease Control and Prevention currently recommends three jabs for everyone age 12 years and up, and two shots for children between the ages of five and 11. Individuals who are immunocompromised are encouraged to get an extra dose. Fourth dose still protects against severe infection, separate study found A separate Israeli study published, on February 1 by the Israeli Health Ministry, offered somewhat contradictory results to the Sheba findings – although the Ministry of Health study focused only on older people. That study, released on the pre-print biomedical website MedRXiv, found that rates of confirmed COVID-19 infection, as well as severe illness, were lower following a fourth dose, when compared to only three doses. Specifically, the team looked at data from 1,138,681 persons aged over 60 years and eligible for the fourth dose between January 15 and 27, 2022 – the height of the Omicron wave in Israel. They compared the rate of confirmed COVID infections and severe COVID illness between those who took a fourth jab at least 12 days earlier and those who only had three doses, or alternatively those who became ill less than a week after receiving the fourth dose. “The rate of confirmed infection was lower in people 12 or more days after their fourth dose than among those who received only three doses and those 3 to 7 days after vaccination by factors of 2.0 and 1.9, respectively. The rate of severe illness was lower by factors of 4.3 and 4.0,” the authors wrote. ‘Vaccines don’t prevent infection’ Professor Cyrille Cohen, head of the immunology lab at Bar-Ilan University, said that the findings from the Sheba study are not surprising; “the vaccines are not good enough to prevent infection, and even more so with the Omicron variant,” he said. However, like Regev-Yochay, Cohen stressed that there is a growing body of data that shows there remains a substantial difference in the levels of protection acquired by people who are vaccinated with two doses and those who get three doses, when it comes to developing severe disease. “Look at the ratio between people age 60 who got three doses and people that were not vaccinated and got two doses. Even with Omicron, the third dose can reduce the chance of developing severe disease by a factor of four or five and for people above 60 that number becomes 10 to 20,” Cohen said. He also noted that a fourth dose also may help the most vulnerable, noting that today, the serious cases in Israel still tend to be older people with comorbidities or unvaccinated people. “Based on that, a fourth dose for selected populations might demonstrate a benefit,” he said. When asked about Bourla’s statement, Cohen said “it was not clear” and that perhaps the Pfizer CEO was referring to people receiving a shot of the Omicron-adapted vaccine, for which data has not yet been released. A multi-country clinical trial of that vaccine is now underway, including a trial arm in Israel. “I am personally extremely curious to see those results,” Cohen said. Image Credits: Screenshot. Attacks on Health Facilities Are Becoming ‘Part of War Strategy’ in Conflict Zones, Warns WHO 16/03/2022 Kerry Cullinan Attacks on health facilities appear to be part of a deliberate war strategy in Ukraine and other recent conflicts, according to the head of the World Health Organization (WHO) health emergencies programme. The WHO has verified 43 attacks on Ukrainian health facilities since Russia’s invasion on 24 February – and it expects further attacks as over 300 health facilities in conflict areas or under Russian control and a further 600 facilities within 10 kilometres of conflict. But WHO Director-General Dr Tedros Adhanom Ghebreyesus told a media briefing on Wednesday that there had also been 46 attacks on health facilities worldwide since the start of 2022, and people caught in conflicts in Tigray, Yemen and Syria were in extreme need of humanitarian assistance. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme, said that in these conflict zones, attacks on health facilities appeared to be deliberate – in complete violation of international law. “We have never seen this rate of attacks on health care, and health care becoming a target in these situations. It’s becoming part of the strategy and tactics of war and it is entirely unacceptable,” said Ryan. “Under international humanitarian law. conflicting parties are actually instructed to specifically take measures to avoid attacking or inadvertently destroying or hurting health workers or health facilities. They don’t bear responsibility not just to not attack. They actually bear responsibility to ensure that they don’t attack to identify those facilities, to deconflict those facilities and to ensure that they do not, as part of their prosecution of war, attack those facilities,” he added. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme. Multiple conflicts out of the global eye “Although Ukraine is the focus of the world’s attention, it’s far from the only crisis to which WHO is responding,” said Tedros. “In Yemen, roughly two-thirds of the population – more than 20 million people – are estimated to be in need of health assistance. In Afghanistan, more than half the population is in need, with widespread malnutrition and a surge in measles among many other challenges. “And in Ethiopia, six million people in Tigray have been under blockade by Ethiopian and Eritrean forces for almost 500 days, sealed off from the outside world. There is almost no fuel, no cash and no communications. No food aid has been delivered since the middle of December and 83% of the population is food insecure,” said Tedros, who is from Tigray and added his family and friends were affected by the blockade. Aid to Ukraine – but little for Tigray WHO Director-General Dr Tedros Adhanom Ghebreyesus. The WHO has been able to deliver about 100 metric tonnes of supplies to Ukraine, including oxygen, insulin, surgical supplies, anaesthetics and blood transfusion kits; oxygen generators, electrical generators and defibrillators. However, it had only received $8million of the $57.5 million it needed to support Ukraine. In contrast, however, it had only been able to airlift 33 metric tonnes of medicines and other supplies to Tigray in December – enough for 300,000 people – after being denied access to the territory since last July. “We estimate that 2,200 metric tonnes of emergency health supplies are needed to respond to urgent health needs in Tigray,” said Tedros. Treatment for 46,000 Tigrayan people living with HIV has been abandoned, as has treatment for people with cancer, diabetes, hypertension and tuberculosis. “The situation in Tigray is catastrophic. The blockade on communications, including on journalists being able to report from Tigray, means it remains a forgotten crisis. Out of sight and out of mind,” added Tedros. “Just as we continue to call on Russia to make peace in Ukraine, so we continue to call on Ethiopia and Eritrea to end the blockade, the siege, and allow safe access for humanitarian supplies and workers to save lives,” said Tedros. Global COVID-19 cases rise again Meanwhile, after weeks of global decline COVID-19 cases are on the rise again, especially in parts of Asia. “In the last week, we saw an 8% increase in cases detected with more than 11 million cases reported to WHO despite a significant reduction in testing that’s occurring worldwide,” said WHO COVID-19 lead Dr Maria van Kerkhove. She ascribed the increase to the spread of the Omicron variant – particularly the BA.2 lineage which is “the most transmissible variant we have seen of the SARS Co-V2 virus to date” – in a context where restrictions were being lifted globally. Ryan added that the virus would move from one “pocket of susceptibility” where immunity was waning to another. “The likelihood is that this virus will echo around the world,” said Ryan. “It will pick up pockets of susceptibility and will survive in those pockets for months and months until another pocket of susceptibility opens up,” said Ryan. “This is how viruses work. They establish themselves within a community and they will move quickly to the next community that’s unprotected. If communities around the virus are well protected, the virus can sustain itself, even in small communities. It can stay there, it can rest there, and then wait until susceptibility grows.” Image Credits: Markus Spiske/ Unsplash. WTO Head Welcomes Compromise on IP Waiver for COVID Vaccines – But Activists and Pharma Express Dismay 16/03/2022 Kerry Cullinan WTO members last week in session at the TRIPS Council, which has been debating a controversial proposal for an IP waiver on COVID products for over a year. The World Trade Organization’s (WTO) Director-Genera, Dr Ngozi Okonjo-Iweala has “warmly welcomed” the breakthrough reached this week over a waiver on intellectual property for the production of COVID-19 vaccines. “This is a major step forward and this compromise is the result of many long and difficult hours of negotiations. But we are not there yet. We have more work to do to ensure that we have the support of the entire WTO Membership,” said Okonjo-Iweala, in a statement on Wednesday. The agreement reached between the European Union, India, South Africa and the United States – referred to in some quarters as “the Quad” – still needs to be put to all 164 WTO members, which typically decides by consensus. However, the compromise now has good chances of being approved since EU countries had been the major opponents to the proposal by South Africa and India, submitted in October 2020, to waive IP on COVID-19 vaccines and other pandemic-related health products for the duration of the pandemic. Major concessions South Africa and India had to make major conceessions – both narrowing the waiver to only vaccines, as well as narrowing the list of countries that would be eligible to take advantage of the waiver on patents and other IP. “My team and I have been working hard for the past three months and we are ready to roll up our sleeves again to work together with the TRIPS Council Chair Ambassador Lansana Gberie (Sierra Leone) to bring about a full agreement as quickly as possible. We are grateful to the four Members for the difficult work they have undertaken so far,” said Okonjo-Iweala. The WTO’s Ministerial Council (MC12), postponed from late November to the week of June 13, could potentially approve the waiver move – although the date of that meeting has also been cast into doubt due to the recent outbreak of war in the Ukraine. However, the draft text of the proposed compromise, published by STAT News Tuesday evening, has elicited dismay from both health activists and the pharmaceutical industry – for not going far enough, or for going too far. Restricted to vaccines and certain developing countries In essence, the compromise does three things: Most critically, the new waiver would allow developing countries to not only manufacture, but also to export, generic versions of COVID vaccines that are still under patent protection. Currently, Article 31.f of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement restricts such generic manufacture to health products that are “predominantly for the supply of the domestic market” – leaving low-income countries with no manufacturing base unable to import cheaper generic versions of products from abroad. However, the waiver would be limited to countries that exported less than 10% of the world’s vaccines in 2021. That effectively excludes well-established manufacturers in China, but not India, from waiver eligibility. In contrast to the original Indian-South African proposal, the new IP flexibilities are restricted to COVID vaccines, thus excluding COVID treatments such as new antivirals that are particularly important for countries with low vaccination rates, as well as tests, personal protective equipment (PPE) and other pandemic-related goods. Adam Hodge, spokesperson for US Trade Representative Ambassador Katherine Tai, said late Tuesday that the “compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome” after a “difficult and protracted process”. Since last May @USTradeRep has worked hard to facilitate an outcome on IP that can achieve consensus across the 164 @WTO Members to help end the pandemic. USTR joined informal discussions led by the WTO Secretariat with South Africa, India, and the EU to try & break the deadlock. — USTR Office of Public Affairs (@USTRSpox) March 15, 2022 He and others cautioned that details of a final text were yet to be concluded. “While no agreement on text has been reached and we are in the process of consulting on the outcome, the US will continue to engage with WTO Members as part of our comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible,” added Hodge. The informal discussions, led by the WTO Secretariat, have been trying to break the deadlock between the India-South Africa waiver proposal (supported by the Africa and Least Developed Nations groups and others) and the EU’s counter-proposal. India-South Africa proposal had sought a broad waiver on all vaccines, tests and treatments, while the EU had pushed for technical modifications in the existing TRIPS rules. Medicines access activists and pharma leaders both express dismay Both activists and industry reacted with dismay to news of the proposed agreement. For example, the US-based consumer advocacy group, Public Citizen, called on WTO member states to reject the proposal. “Among its key limitations: the proposal appears to cover only vaccines (not tests and treatments), cover only patents (not other important intellectual property barriers), be limited geographically, and further undermine current WTO flexibilities for compulsory licenses,” according to Melinda St Louis, director of Public Citizen’s Global Trade Watch division. “It would be a mistake for WTO members to prematurely agree to a weakened waiver that provides political cover to the US and EU while not making any meaningful difference in increasing access to vaccines, tests and treatments. No waiver is better than a weak waiver designed solely to save face,” added St Louis. Knowledge Ecology International also expressed disquiet, saying that the waiver may even restrict certain flexibilities that are already allowed by Article 31 of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), regarding a country’s rights to manufacture and export generic versions of drugs or vaccines during a health emergency. “Countries are required to follow Article 31 of the TRIPS [agreement], which of course, is an existing and not a new flexibility, but with ‘clarifications’,” noted KEI’s Director, James Love. However, those “clarifications”, also come with new obligations that could make Article 31 “more restrictive and burdensome”, such as a new obligation for a country to identify all of the patents to which it is applying an IP waiver, and to notify the WTO of its use of the waiver – something not required for the issuance of compulsory licenses in general. On the other hand, the draft agreement makes a first-ever reference to a 2005 WHO/UNDP guidance on payments by developing countries to the original patent-holder, which embraces the concept of “tiered royalties”, based on a country’s ability to pay, and authored by Love himself. Pharma says agreement sends ‘wrong signal’ Meanwhile, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said that “weakening patents now when it is widely acknowledged that there are no longer supply constraints of COVID-19 vaccines, sends the wrong signal”. “When the IP TRIPS Waiver was first proposed in 2020, it was to the wrong solution to the problem of scaling up manufacturing of potential COVID-19 vaccines which at the time had not yet even been authorized,” said the IFPMA. “Now the problem of supply has been addressed thanks to unprecedented collaboration involving companies from industrialized and developing countries, the TRIPS Waiver is not only the wrong solution, it is also an outdated proposal, that has been overtaken by events.” It added that the TRIPS waiver proposal is “political posturing that are at best a distraction, at worse creating uncertainty that can undermine innovation’s ability to respond to the current and future response to pandemics”. “The current proposals should be shelved; and the focus should be directed, to admittedly more difficult actions that will change lives for the better: supporting country readiness, contributing to equitable distribution, and driving innovation,” the IFPMA concluded. The final text of any agreement would first need to be approved by the WTO TRIPS Council, and then go before the MC12 for final approval. The TRIPS Council last met on 9-10 March, but at the time failed to reach a compromise – although some sources noted that the were close to agreement as the “Quad” of India, South Africa, the United States and the EU scrambled to reach a deal. According to a WTO statement on 10 March, the TRIPS Council had agreed to keep the agenda item on the IP waiver open – so as to enable the council to be “reconvened at short notice if substantial progress is made in the high-level talks”. TRIPS Council approval would pave the way for a consensus agreement at the WTO’s Ministerial meeting, MC12. Russian Soldiers Hold Health Workers and Patients Hostage at Mariupol Hospital, says Human Rights Group 15/03/2022 Kerry Cullinan Mariupol Regional Hospital before it was bombed Health workers, patients and civilians have been held hostage at the Mariupol regional intensive care hospital in Ukraine by Russian troops since Monday morning, according to the Media Initiative for Human Rights (MIHR). Russian soldiers are using the hospital as a base to attack Ukrainian forces, and using the hostages as “human shields” according to MIHR, a respected human rights monitoring group in Ukraine. “We received information from a doctor from the hospital. We can’t name him because of the threat to him. More information will be available after the person is safe,” the MIHR reported on its Facebook page. Pavlo Kyrylenko, head of the Donetsk regional administration, also reported the hostage situation on his Telegram account. Kyrylenko reported that a hostage had told him: “It is impossible to leave the hospital. There is heavy shelling. We sit in the basement. Cars have not been able to drive into the hospital for two days. High-rise buildings are burning around… Russians rushed 400 people from neighbouring houses to our hospital. We can’t leave. “ While the 550-bed tertiary hospital, the biggest in the Donetsk region, has suffered extensive damage, health workers have continued to attend to patients from the basement. “I appeal to international human rights organizations to respond to these vicious violations of the norms and customs of war, to these egregious crimes against humanity,” said Kyrylenko. Humanitarian groups have been appealing for days for a safe passage corridor to and from Mariupol. Some private cars were finally able to leave the city on Monday and Tuesday, the first time in 10 days. But Russian troops that have beseiged the city on all sides have not allowed relief workers to bring in desperately needed medical supplies, food or water. Mariupol. Direct strike of Russian troops at the maternity hospital. People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror? Close the sky right now! Stop the killings! You have power but you seem to be losing humanity. pic.twitter.com/FoaNdbKH5k — Volodymyr Zelenskyy / Володимир Зеленський (@ZelenskyyUa) March 9, 2022 Last week, Russian troops bombed the Mariupol maternity hospital, reportedly killing at least three people. A pregnant woman evacuated from the hospital and her baby later died from their injuries. Mariupol’s deputy mayor, Sergey Orlov, told France24 on Tuesday that at least 2,358 people had been killed during the 11-day siege of the south-eastern city, and he had been fielding desperate calls from people trapped in basements without food or water. While small numbers of people escaped the besieged city on Monday after a series of failed evacuation attempts, as many as 2,500 civilians have died in Mariupol, Ukrainian officials estimate https://t.co/1ksWTFnzaf — CNN International (@cnni) March 15, 2022 ‘Act of unconscionable cruelty’ The World Health Organization (WHO) has verified 31 attacks on health facilities between the start of the Russian invasion on 24 February and 11 March, resulting in 12 deaths and 34 injuries, of which 8 of the injured and 2 of those killed were health workers. My hometown Volnovakha. I was born at this hospital. Now it’s officially denazified and liberated by Russia. pic.twitter.com/nV9lyZX4uQ — Illia Ponomarenko 🇺🇦 (@IAPonomarenko) March 15, 2022 “We call for an immediate cessation of all attacks on health care in Ukraine. These horrific attacks are killing and causing serious injuries to patients and health workers, destroying vital health infrastructure and forcing thousands to forgo accessing health services despite catastrophic needs,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, UNICEF Executive Director Catherine Russell and UNFPA Executive Director Dr Natalia Kanem, in a joint statement on Sunday. “To attack the most vulnerable – babies, children, pregnant women, and those already suffering from illness and disease, and health workers risking their own lives to save lives – is an act of unconscionable cruelty,” they added. “We must be able to safely deliver emergency medical supplies – including those required for obstetric and neonatal care – to health centers, temporary facilities and underground shelters.” Intentionally attacking health facilities is prohibited under international humanitarian law. Unusual position of surrogates Since the start of the war, more than 4,300 Ukrainian women have given birth, and 80,000 others are expected to give birth in the next three months. “Oxygen and medical supplies, including for the management of pregnancy complications, are running dangerously low,” according to the three leaders. “Many pregnant women may need health care, medication and assistance on a daily basis or when complications with pregnancy occur. When medical facilities are not accessible, are destroyed, or health care personnel and medical product are scarce or unavailable, maternal health can be endangered,” according to Eszther Kisomodi and Emma Pitchford, the chief executive and executive editor respectively of the journal, Sexual and Reproductive Health Matters. They also warned that many pregnant women might be in “particular and unusual situations” as Ukraine “is an international surrogacy hub, one of only a handful of countries in the world that legally allows foreigners to enter into surrogacy arrangements”. https://twitter.com/thedalstonyears/status/1501861609446289410 “Being a surrogate is a job in Ukraine for many women, but not one that they can quit, or even put on hold. Very serious questions occur for all parties in this arrangement – for the pregnant women, the newborn child and the intended parents.” The authors also highlight the precarious position of people with disabilities who cannot move easily, LBGTQ people in the face of hostile Russian forces, and people living with HIV in Ukraine, which has the second-highest infection rate in Europe. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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Mass Polio Vaccination Drive to Administer More Than 80 Million Doses to Southern African Children in Five Countries 18/03/2022 Raisa Santos Polio vaccinate campaign to target children under 5 across five southern African countries. Malawi is launching a mass vaccination campaign against wild poliovirus type 1, which is to extend to 23 million children across five southern African countries, WHO said on Friday. The campaign, to kick off Sunday, follows Malawi’s declaration of a polio outbreak on 17 February – three months after the first polio virus case in 30 years was identified in a young child in Lilongwe. The case was the first in Africa since the region was certified free of indigenous wild poliovirus in 2020. WHO said that the region’s certification as wild polio-free remains unchanged, as the wild poliovirus strain identified had been “imported” from Pakistan. So far, no clear explanation of how the Asian virus strain may have infected an African child who had never traveled outside of the country, has been provided by WHO or Malawi health authorities. Nor has there been any explanation of why it took three months between the time the child was diagnosed and the outbreak was formally declared by WHO. But the breadth of the new campaign makes it clear the incident has been perceived as a major threat to Africa’s wild polio virus free status – with risks of subtle, silent transmission of the virus much more widely, via contaminated water and sewage, food, or human-to-human contact. Malawi has since set up an environmental surveillance system for poliovirus in 11 cities across four sites, including the Lilongwe District that encompasses the capital Lilongwe, where the initial, and so far only reported case, was detected, WHO said. Asked by Health Policy Watch whether traces of the wild polio virus had also been identified in sewage sources, through the environmental surveillance, WHO did not reply as of publication time. Targeting children across four countries – then Zimbabwe More than 80 million doses will be administered to more than 23 million children under 5 years in a four-round vaccination campaign in five southern African countries, WHO said. The first phase of the campaign, beginning this month, will target 9.4 million children across Malawi, Mozambique, Tanzania, and Zambia. Three subsequent rounds – with Zimbabwe joining the campaign- are set for April, June, and July, and aim to reach more than 23 million children with more than 80 million doses of the bivalent Oral Polio Vaccine recommended by the World Health Organization (WHO). “Polio is a highly infectious and an untreatable disease that can result in permanent paralysis. In support of Malawi and its neighbours, we are acting fast to halt this outbreak and extinguish the threat through effective vaccinations,” said WHO Regional Director for Africa Dr Matshidiso Moeti. “The African region has already defeated wild poliovirus due to a monumental effort by countries. We have the know-how and are tirelessly working to ensure that every child lives and thrives in a continent free of polio.” Single case of polio in Malawi linked to Pakistan strain Pakistan is one of two countries where polio remains endemic. Laboratory analysis has linked the strain detected in Malawi to the one circulating in Pakistan’s Sindh Province in 2019. In addition to environmental surveillance, WHO has also been supporting the country to reinforce response measures including risk assessment, and preparations for the vaccination campaigns. A surge team from WHO is working with country-based counterparts, partner organizations, and the government to end the outbreak. The WHO team is a part of a broader multi-partner Global Polio Eradication Initiative to support the country. In an unrelated event, a vaccine-directed case of polio was also identified in February by Israeli authorities in Jerusalem, also for the first time in 30 years. The infected child is part of an ultra-orthodox Jewish community in which vaccination rates hover at around 50% or less. A vaccination drive also was launched in the city. Polio, a viral disease with no cure, can invade the nervous system and can cause total paralysis within hours, particular among children under 5 years. The virus is transmitted from person to person, mainly through contamination by fecal matter or, less frequently, through contaminated water or food, and multiplies in the intestine. While there is no cure for polio, the disease can be prevented through administration of a vaccine. Image Credits: Sanofi Pastuer/Flickr, Sanofi Pastuer/Flickr. UN Environment Programme Joins WHO Alliance to Advance One Health Approach 18/03/2022 Editorial team Safer and more sustainable food systems – from production to sales in food markets is key to a One-Health Approach. UN Environment has joined a three-way alliance with the Food and Agriculture Organization, the World Animal Health Organization (OIE), and WHO to advance “One-Health” solutions to both ecosystem degradation and pandemic threats, leaders of the four agencies said on Friday. The statement followed a meeting this week of the Tripartite FAO, WHO and OIE partnership – which now has become a “Quadripartite”. “The One Health approach aims to sustainably balance and optimize the health of people, animals, ecosystems and the wider environment,” said WHO in a press release. “It mobilizes multiple sectors, disciplines and communities to work together to foster well-being and tackle threats to health and ecosystems. And it addresses the collective need for clean water, energy and air, safe and nutritious food, action on climate change, and contributing to sustainable development.” The work of the newly expanded alliance will be focused on a One Health Joint Plan of Action, which includes six main action tracks: enhancing countries’ capacity to strengthen health systems under a One Health approach; reducing the risks from emerging or resurfacing zoonotic epidemics and pandemics; controlling and eliminating endemic zoonotic, neglected tropical or vector-borne diseases; strengthening the assessment, management and communication of food safety risks; curbing the silent pandemic of antimicrobial resistance (AMR) and better integrating the environment into the One Health approach. Increased awareness of One Health As the world enters the third year of the COVID-19 pandemic, with an estimated cost of $8 to 16 trillion, there is increased awareness and broad recognition of the importance of One Health as a long-term, viable and sustainable approach. The G7, G20 and UN Food Systems Summit have all given a nod to the approach, along with the increased references by WHO and its partners. But the hard work of reforming food systems, from production to markets, as well as halting related deforestation and ecosystem destruction, are much more formidable challenges that the organisations have barely begun to face. Last year saw the Tripartite implement a number of initial initiatives, including on antimicrobial resistance, a One Health High-Level Expert Panel, and guidance on better management – but not the banning – of wild animal sales in markets – in the wake of the COVID pandemic, whose origins may have emerged from the capture, transport and slaughter of SARS-CoV2 infected wild animals at the Wuhan, China market. Plan implementation the key challenge “Now the challenge is implementation: how do we translate our work on the ground to support our Members? And how do we mobilize funding and financing mechanisms to support the Joint Plan for Action?” said FAO Director QU Dongyu, handing over the chair of the Secretariat to WHO. WHO Director-General Tedros Adhanom Ghebreyesus, said: “We need to build a more comprehensive and coordinated One Health governance structure at global level. We need a strong workforce, committed political will, and sustained financial investment. We need to develop a more proactive way of communicating and engaging across sectors, disciplines and communities to elicit the change we need.” (WHO) Image Credits: Michael Casmir/Pierce Mill Media. Healthy Mouths, Healthy Planet 18/03/2022 Ihsane Ben Yahya, Nicolas Martin & Steven Mulligan Dental procedures produce a hefty amount of carbon emissions. In honour of World Oral Health Day, 20 March, three leading voices from the World Dental Federation highlight the unexpected linkages between the health of your mouth and that of the planet. It will come as a surprise to most people that the healthcare sector has a significant environmental impact. Healthcare systems are responsible for around 5% of global greenhouse gas emissions, of which oral healthcare is an important contributor. Indeed, if the healthcare sector was a country, it would be the fifth largest greenhouse gas emitter on the planet. Oral healthcare contributes to this environmental burden with air pollution arising from the release of CO2 associated with travel and transport, the incineration of waste, the greenhouse gas impact of anesthetic gases such as nitrous oxide and the high consumption of water. Specific to dentistry, the most routine procedures, all come with a hefty carbon price tag. Tooth-coloured fillings for instance, produce around 15 kilograms of CO2eq (carbon dioxide equivalent) per procedure, according to Public Health England, whose National Health Service has done some of the most extensive carbon footprint modeling of healthcare delivery in the world. A single root canal treatment, meanwhile, produces 23 kilograms of CO2eq, dentures between 58 and 71 kilograms CO2eq. Use of the anesthetic gas nitrous oxide (laughing gas), in a procedure, meanwhile, is responsible for 119 kilograms CO2eq. Nitrous oxide N2O, the most commonly used inhalation dental anesthetic, is a greenhouse gas with far more climate warming potential than CO2. Just one kilogram of nitrous oxide is equivalent to 298 kilogrammes of CO2 and 25 kilograms of methane – another powerful greenhouse gas. Meanwhile, silver amalgam fillings contain mercury. While more and more rarely used today, and still considered safe for dental treatments, there is an environmental impact through the release of residual mercury into sewage during procedures, as well as throughout its life cycle. Prevention is better than cure Ways to maintain good oral health. The dental industry has a collective responsibility to reduce these impacts – while also expanding access to oral healthcare. How can we do both? One simple solution is to look at how we can best minimize what we might label as “avoidable” oral procedures. Prevention is always better than cure and it is the most impactful and practical way of reducing the need for clinical interventions and their associated environmental impacts. This is best achieved through the promotion of good oral hygiene, a healthy diet and the avoidance of smoking. When treatment is required, oral healthcare also should focus on the provision of durable fillings, using high quality products and materials that will last longer and/or require fewer replacements. Legislation around water fluoridation for instance, complemented by targeted public health policies can help prevent tooth decay (caries) and ultimately cavities. The recent banning of TV and online advertising of junk food in the UK before 9pm is an indirect example of encouraging better diet. So too the campaign by UK footballer Marcus Rashford to promote healthier school lunches. At the same time, while many dental problems such as caries and periodontal (gum) disease are common preventable diseases, no amount of prevention can make them go away entirely. There will always be a need for accessible dental check-ups and treatments to facilitate good oral health. And it remains important to expand access to such treatments among disadvantaged groups as well as in many low- and middle-income countries so as to reduce inequalities in healthcare provision. Less trips to the dentist would also mean less travel and water consumption Dental procedures require a lot of water, which can be reduced by practicing good oral healthcare. Oral healthcare has higher levels of patient and staff transport than other medical specializations and this is partly due to the need for regular oral health maintenance, whereas other specializations tend only to treat illness. In the UK for instance, staff and patient commuting and travel accounts for approximately two thirds of all emissions from the oral healthcare sector and about eight per cent of the total UK NHS air pollution attributable to travel. This can be reduced significantly, through the maintenance of good oral health, that requires fewer interventions and consequently fewer trips to the dentist. Simple transport habit changes can have a great impact. For example, in October 2021 the Sustainability Committee at Harvard School of Dental Medicine (HSDM) implemented a `Step Challenge´ that encouraged staff, students and faculty to walk, or take public transport rather than drive during that month. They amassed over one million steps in total, preventing the release of approximately 0.28 metric tons of CO2. The practice of dentistry and personal oral healthcare is a significant consumer of water. As a conservative estimate, a bathroom tap delivers about four litres/minute. If we estimate that half the world population cleans their teeth once a day and runs the tap for one minute, the daily global water usage equates to 6,400 Olympic swimming pools. This figure is in addition to undocumented water consumption up and down the oral healthcare manufacturing and distribution supply chain. Reducing dental use of single use plastics and packaging Measures to reduce carbon footprint in dental offices. So what measures can be taken at the dentist office to reduce the carbon footprint of dentistry procedures that are nonetheless essential to good oral health? The use and consequent disposal of single use plastics for many procedures is one of the biggest contributors to the environmental footprint of healthcare generally – and that holds true for dentistry as well. Among single-use plastics, in fact it is the packaging in which the needles, gloves and other oral healthcare products are encased that is the single largest contributor to such waste in the dental industry, with over 90 % ending its life cycle in an incinerator or a landfill. A more thoughtful approach to the design of such packaging – from the plastics content, manufacture and transport, to the potential for reuse, recycling or biodegradability, is therefore one obvious starting point in reducing the carbon footprint of the typical dentist’s office. This is particularly important because packaging, as such, is not “contaminated” biomedical waste that needs special treatment, post-procedure. This requires greater engagement with consumers and waste management companies to segregate, collect and recycle uncontaminated clinical single use plastics (SUPs) as a valuable commodity. It also involves the design and development of more plastic items made from mono-polymer plastics that can be readily recycled. The Flexible Plastics Consortium which represents 34 European companies looking for better plastics content and design solutions for packaging is a good example of how this might work in practice. The United Kingdom’s Plastics Pact is another good example: it has set targets with the goal of 100% of plastic packaging to be reused, recycled or compostable by 2025. Major challenges in managing single use plastic waste from oral healthcare Many single use dental items end up in the waste bin, including gloves, aprons, masks. Once the box is opened, many of the everyday products used in dentistry are only briefly used and then end up in the waste bin. These single-use plastic (SUP) items range from personal protective equipment (aprons, gloves and masks) and other disposable sundries (the mouth-rinse cup or the dental suction tube). SUP biomedical waste requires more specialized management – since these are contaminated with blood and other bodily fluids from oral health procedures. The high safety and quality requirements for these products to be legally compliant, is often incompatible with recycling and materials recovery. The complex nature of items assembled from different plastics also makes recycling difficult, as does the prevailing view that plastic is simply waste and is not considered a valuable resource. Still there are many attempts at finding solutions around the world. These include incentivization schemes and professional education courses that can help manufacturers to design products that can be safely treated and reprocessed, as well as sensitizing dental practitioners to different waste streams, and the treatment they require. Initiatives like the development of a competency-based dental waste management course being undertaken at the Copperbelt University in Zambia are a step in the right direction. Even so, the lack of good technological solutions for the appropriate collection, disinfection/sterilization and subsequent recovery or reprocessing of single use plastics used in biomedical procedures remains an ongoing barrier. We need product research to come up with safe, sustainable solutions for a circular economy, including in the healthcare sector, and governments to adopt supportive policies. Assessing the environmental impacts of oral healthcare as a first step It is important to understand the environmental impacts of materials used in healthcare. A better understanding of the environmental impacts of products and materials used in healthcare systems, from procurement to disposal, is key to any of these measures. Solutions proposed have included more life cycle analysis for all materials used in the healthcare supply chain and the development of a credible ‘sustainability index’ to inform medical supply purchasers about the sustainability credentials of a product. The index could potentially include information on environmental sourcing, ethical manufacturing, supply chain distribution and procurement. This World Oral Health Day we can celebrate the fact that the oral health sector has recognised that it has a vital role to play in healthcare-related climate change mitigation. That is the first step. The next ones will be more challenging and will need ‘teeth’. The FDI World Dental Federation´s Code of Good Practice, which is to be launched later this year, following an extensive consultation with the sector, will be a good starting point for ensuring healthy mouths also help to produce a healthier planet. Steven Mulligan Nicolas Martin Ihsane Ben Yahya Ihsane Ben Yahya is the President of the FDI World Dental Federation and professor at the Dental University in Casablanca, Morocco. Nicolas Martin is the Chair of the FDI Sustainability in Dentistry Task Team. He is also Clinical Professor in Restorative Dentistry in the School of Clinical Dentistry, at the University of Sheffield, UK. Steven Mulligan is a Member of the FDI Sustainability in Dentistry Task Team. He is also a Clinical Lecturer in Restorative Dentistry in the School of Clinical Dentistry, at the University of Sheffield, UK. Image Credits: Mass Communication Specialist Seaman Apprentice Brian H. Abel/Flickr, FDI World Dental Federation , Jan Fidler/Flickr, World Dental Federation , Mass Communication Specialist 3rd Class Everett Allen/Flickr. From COVID to Humanitarian Crises – Medical Oxygen Needs More Prioritization for its Lifesaving Capacities 17/03/2022 Raisa Santos Lifesaving oxygen flows into the lungs of a COVID patient in Chernivtsi, southwest Ukraine before the start of the recent Russian invasion. Whether its due to COVID or conflict, oxygen supplies fall short in many parts of the world. From patients lying in the parking lots of hospitals, in the back seats of cars suffocating as their family members searched frantically for oxygen in India during its second wave of COVID last year, to the inability to receive emergency care amidst constant bombing and shelling in current war-torn Ukraine, global health experts and leaders are desperately searching for ways of improving the global oxygen supply. At a media briefing on the issue Thursday, speakers emphasized the need for both access to oxygen on the ground and more funding to the WHO co-sponsored Access to COVID-19 Tools Accelerator (ACT-A), which is attempting to beef up oxygen supplies in low and middle-income countries. “Oxygen has been treated for too long like a commodity, treated as something that must be delivered,” said WHO Executive Director of Health Emergencies Programme Dr Mike Ryan, speaking at the briefing, cosponsored by the Act Acccelerator and Unitaid. But “oxygen is a capability, not a commodity,” he stressed. Rethinking oxygen’s lifesaving capacities Mike Ryan, Executive Director, Health Emergencies Programme; World Health Organization Ryan and others made the case for rethinking oxygen as a health tool that requires not only a sustainable supply at a country level, but an entire ecosystem of supply and maintenance technology and infrastructure. Its role – and the chronic lack of capacity in many countries – has been underscored by COVID – and again in the very different setting of the Ukraine crisis – where the lack of access for people ranging from COVID patients to mothers in birth and children with pneumonia has prompted widespread alarm. Oxygen remains a critical component of the global COVID-19 response – 75% of patients hospitalized for COVID-19 can be treated with oxygen alone – without any further advanced care. Yet the current global supply of oxygen does not meet needs for both COVID-19 and other serious illnesses. “COVID didn’t cause [the oxygen shortage], COVID uncovered this. COVID laid bare, tore away the bandages from some very old wounds,” said Ryan. UNITAID Commits $56 million to boost access to global medical oxygen supply Robert Matiru, Chair, ACT-A Oxygen Emergency Taskforce & Director Programmes, Unitaid The ACT-A Strategic Plan and Budget for 2022 has identified a funding deficit of $1 billion for oxygen supplies worldwide for this year alone. As a first step to closing that gap, Unitaid has announced that it will invest $56 million to increase access to medical oxygen both for short-term needs related to COVID-19 as well as for the longer term – as a critical foundation for fighting future pandemics. The Unitaid pledge builds on the $50 million USAID has committed in funding for oxygen as pledged at US President Joe Biden’s Global COVID-19 Summit in September 2021. Four Unitaid-funded projects, designed to address global inequities in oxygen access, will be implemented by The Alliance for International Medical Action (ALIMA), the Clinton Health Access Initiative (CHAI), Partners in Health (PIH), and the WHO Health Emergencies Programme. These will also support the work of the ACT-A Oxygen Emergency Task Force by ensuring access to more affordable oxygen solutions such as bulk liquid oxygen, oxygen generation systems, and other important oxygen equipment. Unitaid called on donors, including governments, foundations, and private sector partners to join in the efforts. “Our call here is not just for the present, for this pandemic, but to recognize that donors and funders that come forward and step forward, over and above the generous contributors to date, will help drive a more sustainable ecosystem and [deliver] essential medicines to countries that are lacking it,” said Robert Matiru, Chair of the ACT-A Oxygen Emergency Taskforce and Director of Programmes at Unitaid. Children with pneumonia unrecognized victims – 40% of hospitals in some African countries lack oxygen Numerous countries are facing oxygen shortages, while readily available oxygen products are in short supply. Children are among the unrecognized victims of the lack of oxygen supplies – with childhood pneumonia still one of the biggest killers of under-fives. Accounting for almost a million deaths a year, the highest burden is in sub-Saharan African and South-East Asian countries where children face a double whammy of disease from both the lack of preventive treatments, like vaccinations, along with exposure to heavy indoor air pollution from the open burning of coal, biomass and other such fuels. But an estimated 20 to 40% of these deaths are preventable with increased availability of oxygen therapy. The shortage is particularly acute in low-income sub-Saharan African countries such as Tanzania, Sierra Leone, Liberia, and Gambia, where 40% of health facilities had no access to oxygen and other basic life saving supplies, said Atul Gawande of the United States Agency for International Development (USAID). COVID has led to big surges in needs Daily medical oxygen need for COVID-19 as of 16 March 2022 Along with the chronic shortages, COVID led to a major surge in oxygen needs. Low and middle-income countries (LMICs) need at least 23 million cubic meters of oxygen every day, just to treat COVID patients alone, according to the PATH COVID-19 Oxygen Needs Tracker. On the brighter side, the pandemic has brought a long-ignored aspect of health capacity in LMICs more to the forefront. USAID is currently working in 11 countries to build ‘oxygen ecosystems’ to support oxygen therapy for pneumonia patients, COVID patients, and others, Gawande said. Countries like Ghana now have oxygen generating capacity that can support up to 300,000 patients per day, per year. Gawande noted that the oxygen ecosystem includes liquid oxygen cylinders and concentrators, as well as the clinical engineering and technical assistance to use the technology. But expanding this initiative to other countries still needs more funding. Atul Gawande, USAID “As the Omicron variant abates, I think we’re all starting to feel that we can catch our breath. Oxygen demand may be lower right now. But it is the time that we have to make these investments to enable this kind of [sustainable] capacity.” Gawande said. Oxygen ‘natural security’ and ‘high-return’ health investment Leith Greenslade, Founder/CEO, JustActions & Coordinator, Every Breath Counts Coalition While the recent funding commitments are a positive sign, ‘it is not enough to fund protection’, said Leith Greenslade of the Every Breath Counts Coalition. “It took a pandemic of respiratory infection to wake up the world,” she pointed out. In the past year, about $700 million was invested into the ACT-A Oxygen Emergency Task Force, which has worked in LMICs to prevent oxygen shortages – jump-starting a more focused response. But so far, only a handful of governments – including the United States, Germany, Canada, and France – have borne the funding burden. “But most of the G-20 nations have not stepped up to invest in oxygen,” she charged. Greenslade appealed to donors to see oxygen as a high priority for three reasons: the moral obligation to flatten the COVID-19 curve; oxygen as a “national security” issue in moments of crisis; and finally, oxygen as a high-return health investment that will keep on saving lives beyond the pandemic. “When hospitals run out of oxygen, we have seen strikes and civil unrest in quite a few low- and middle-income countries,” she pointed out. “How many more deaths before this is over will largely depend on access to oxygen and critical care in the countries where the disease is greatest and the health systems are weakest,” she declared. Image Credits: Mstyslav Chernov/ Wikimedia Commons, UNICEF/Ralaivita, PATH, Every Breath Counts . Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates 17/03/2022 Elaine Ruth Fletcher Pfizer’s Paxlovid, an oral antiviral approved by the US FDA in December, has shown 90% efficacy in preventing mortality among those who take it in the first few days of infection. A Medicines Patent Pool (MPP) announcement Thursday that it has signed agreements with 35 companies to manufacture generic versions of Pfizer’s life-saving COVID-19 Paxlovid treatment for distribution in 95 low- and middle-income countries came fire almost immediately from medicines access groups as too little, too late. The MPP-brokered sublicences follow on from an agreement between MPP and Pfizer in November 2021 to supply generic versions of Pfizer patented main drug ingredient, nirmatrelvir, at cost, to countries that represent about 53% of the world’s population. However, activists quickly slammed with the new accord – saying that it would take up many months to actually set up the generic production lines of the game-changing oral drug, which in clinical trials, reduced COVID mortality by 90% among high risk groups. Mapping of the MPP-brokered licenses awarded for manufacture of a generic version of Paxlovid In a joint letter to Pfizer CEO Albert Bourla, delivered Wednesday, a consortium of 100 activist groups, including Amnesty International and Oxfam, said that Pfizer should immediately dedicate two-thirds of the company’s available patented drug supply to low- and middle-income countries, “where there is a proportionate need.” “At present, Pfizer has preferentially sold all of its Paxlovid doses from the first half of 2022 to a handful of high-income countries, and has tentatively promised to supply only 10 million courses of treatment of LMICs,” stated the Health Global Access Project (Health Gap), one of the signatories to Wednesday’s letter, in a follow-up blog posted online just after the MPP announcement. The activists also have slammed the still high price of the new drug in upper-middle and high income countries, saying that this also creates barriers to access. The United States is paying about $530 a day for a five-day course, although Pfizer has committed to a 3-tiered pricing system with lower costs to less affluent countries. “This announcement will do nothing to eliminate the monopoly Pfizer maintains over unlicensed countries – all high-income and almost all upper-middle income countries, representing 47% of the world’s population and historically experiencing the highest rates of COVID-19 infection,” added Brook Baker, Health Gap Senior Policy Analyst and a Professor at Northeastern University School of Law. MSF – A ‘positive step’ forward Médecins Sans Frontières sounded a more positive note, however, saying that the Pfizer agreement with 35 generics manufacturers in 12 countries represents a “positive step toward addressing the ongoing access challenges for this COVID treatment. However, the limitations of the deal remain concerning.” “The limited global supply from the US corporation Pfizer has so far largely been bought up by a number of high-income countries. It is estimated that generic manufacturers will not be able to bring supply to the market until 2023,” stated MSF. Replying to the criticism, an MPP spokesperson stressed that the new agreement “includes all low and lower-middle-income countries as well as some upper-middle income countries in Sub-Saharan Africa that have transitioned to upper-middle-income status in the past five years. The 53% of the world’s population covered by the licenses, “which is equivalent to about 4.1 billion people. As with all our licences we will continue to explore opportunities to broaden geographic scope, where possible,” the MPP spokesperson added. Design of MPP agreement According to MPP, the non-exclusive sublicence deals will allow generic manufacturers to produce the raw ingredients for Paxlovid’s main active ingredient, nirmatrelvir, and/or the finished drug itself, which is co-packaged with a common HIV drug, ritonavir. It said that six companies will focus on producing the drug substance, nine companies will produce the finished drug product and the remainder will do both. The manufacturers are based in 12 countries including: Bangladesh, Brazil, China, Dominican Republic, Jordan, India, Israel, Mexico, Pakistan, Serbia, Republic of Korea, and Vietnam. “A licence has also been offered to a company in Ukraine, the offer will remain available to them as they are not able to sign due to the current conflict,” MPP said. The deal signed between MPP and Pfizer in November 2021 established the terms and conditions, for the generic licenses, MPP added. Following that, “The requests for sublicences from generic producers were reviewed by MPP and presented to Pfizer,” for its approval – one of the conditions of the sale. Pfizer will not receive royalties from sales of nirmatrelvir from the MPP-negotiated sublicensees for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization, MPP added. Following the pandemic period, sales to low-income countries will remain royalty free, lower-middle-income countries and upper-middle-income countries will be subject to a 5% royalty for sales to the public sector and a 10% royalty for sales to the private sector. “Nirmatrelvir is a new product and requires substantial manufacturing capabilities to produce, and we have been very impressed with the quality of manufacturing demonstrated by these companies,” said Charles Gore, MPP Executive Director. “Furthermore, 15 companies are signing their first licence with MPP, and we warmly welcome our new generic manufacturing partners.” “We have established a comprehensive strategy in partnership with worldwide governments, international global health leaders and global manufacturers to help ensure access to our oral COVID-19 treatment for patients in need around the world, said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “The MPP sublicensees and the additional capacity for COVID-19 treatment they will supply will play a critical role to help ensure that people everywhere, particularly those living in the poorest parts of the world, have equitable access to an oral treatment option against COVID-19.” Image Credits: Pfizer , Medicines Patent Pool . Fourth COVID Vaccine Jab Provides Little Extra Protection to Healthy Individuals – NEJM 16/03/2022 Maayan Hoffman A month after a fourth dose of the Pfizer or Moderna vaccines was administered to hundreds of people in an Israeli clinical trial, authors of the new study on the extra booster say it provides “little protection, if any, from infection by COVID-19 among vaccinated young and healthy individuals in comparison to those vaccinated with only a third dose.” Result of the open-label study, conducted at Israel’s Sheba Medical Center, were published Wednesday evening in the New England Journal of Medicine as a correspondence. The findings contradict statements made by Pfizer CEO Albert Bourla over the weekend that a fourth booster dose could necessary for most people, due to waning immunity. Bourla made the statement as Pfizer seeks quick US Food and Drug Administration approval of a fourth dose, effectively a second booster, for people 65 and older. The new Sheba study included approximately 600 volunteers, among them 270 who received a fourth shot of either the Moderna or Pfizer vaccine. All of the volunteers had received three shots of the Pfizer vaccine prior to the trial. Sheba’s Professor Gili Regev-Yochay, lead author of the study, said in a statement that COVID infection rates among four-time vaccinated individuals were only slightly lower than those in the control group. However, she added that the fourth jab did provide moderate protection against symptomatic infection among young and healthy individuals, in comparison to those who had only received three jabs. “We found no differences, both in terms of IgG antibody levels and in terms of neutralizing antibody levels,” added Regev-Yochay, referring to the impact of the fourth jab on the study group in comparison to the control. “It should be emphasized that the third dose is extremely important for anyone who has not yet contracted COVID-19,” Regev-Yochay stressed, “and the fourth dose is most likely important for populations with risk factors, for which a fourth vaccine would protect from serious illness.” The NEJM correspondence, however, said that the fourth dose was “immunogenic, safe and somewhat efficacious”, adding that “our results suggest that maximal immunogenicity of mRNA vaccines is achieved after three doses and that antibody levels can be restored by a fourth dose.” The researchers added that they observed “low vaccine efficacy against infections in health care workers, as well as relatively high viral loads suggesting that those who were infected were infectious.” Bourla: Fourth shot ‘necessary’ The release of the data comes at an awkward time for Pfizer, after a weekend when Bourla said in an interview with CBS’s Face the Nation that a fourth COVID-19 shot would be “necessary” for most people to prevent future infection. Pfizer CEO Albert Bourla in a CBS interview on March 13, 2022. “Right now, the way that we have seen, it is necessary, a fourth booster right now,” Bourla said in the interview. “The protection that you are getting from the third, it is good enough, actually quite good for hospitalizations and deaths. It’s not that good against infections, but doesn’t last very long.” While Bourla said Pfizer had submitted data on the efficacy of the fourth shot to the US FDA, the data has not yet been publicly released. 1. A fourth dose of the Covid-19 vaccine is necessary for most people due to waning immunity, said Pfizer CEO Albert Bourla. He noted that the regimen of two doses plus a booster is not able to offer sufficient protection against new variants. pic.twitter.com/XPCFwiqluD — BFM News (@NewsBFM) March 14, 2022 The US Centers for Disease Control and Prevention currently recommends three jabs for everyone age 12 years and up, and two shots for children between the ages of five and 11. Individuals who are immunocompromised are encouraged to get an extra dose. Fourth dose still protects against severe infection, separate study found A separate Israeli study published, on February 1 by the Israeli Health Ministry, offered somewhat contradictory results to the Sheba findings – although the Ministry of Health study focused only on older people. That study, released on the pre-print biomedical website MedRXiv, found that rates of confirmed COVID-19 infection, as well as severe illness, were lower following a fourth dose, when compared to only three doses. Specifically, the team looked at data from 1,138,681 persons aged over 60 years and eligible for the fourth dose between January 15 and 27, 2022 – the height of the Omicron wave in Israel. They compared the rate of confirmed COVID infections and severe COVID illness between those who took a fourth jab at least 12 days earlier and those who only had three doses, or alternatively those who became ill less than a week after receiving the fourth dose. “The rate of confirmed infection was lower in people 12 or more days after their fourth dose than among those who received only three doses and those 3 to 7 days after vaccination by factors of 2.0 and 1.9, respectively. The rate of severe illness was lower by factors of 4.3 and 4.0,” the authors wrote. ‘Vaccines don’t prevent infection’ Professor Cyrille Cohen, head of the immunology lab at Bar-Ilan University, said that the findings from the Sheba study are not surprising; “the vaccines are not good enough to prevent infection, and even more so with the Omicron variant,” he said. However, like Regev-Yochay, Cohen stressed that there is a growing body of data that shows there remains a substantial difference in the levels of protection acquired by people who are vaccinated with two doses and those who get three doses, when it comes to developing severe disease. “Look at the ratio between people age 60 who got three doses and people that were not vaccinated and got two doses. Even with Omicron, the third dose can reduce the chance of developing severe disease by a factor of four or five and for people above 60 that number becomes 10 to 20,” Cohen said. He also noted that a fourth dose also may help the most vulnerable, noting that today, the serious cases in Israel still tend to be older people with comorbidities or unvaccinated people. “Based on that, a fourth dose for selected populations might demonstrate a benefit,” he said. When asked about Bourla’s statement, Cohen said “it was not clear” and that perhaps the Pfizer CEO was referring to people receiving a shot of the Omicron-adapted vaccine, for which data has not yet been released. A multi-country clinical trial of that vaccine is now underway, including a trial arm in Israel. “I am personally extremely curious to see those results,” Cohen said. Image Credits: Screenshot. Attacks on Health Facilities Are Becoming ‘Part of War Strategy’ in Conflict Zones, Warns WHO 16/03/2022 Kerry Cullinan Attacks on health facilities appear to be part of a deliberate war strategy in Ukraine and other recent conflicts, according to the head of the World Health Organization (WHO) health emergencies programme. The WHO has verified 43 attacks on Ukrainian health facilities since Russia’s invasion on 24 February – and it expects further attacks as over 300 health facilities in conflict areas or under Russian control and a further 600 facilities within 10 kilometres of conflict. But WHO Director-General Dr Tedros Adhanom Ghebreyesus told a media briefing on Wednesday that there had also been 46 attacks on health facilities worldwide since the start of 2022, and people caught in conflicts in Tigray, Yemen and Syria were in extreme need of humanitarian assistance. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme, said that in these conflict zones, attacks on health facilities appeared to be deliberate – in complete violation of international law. “We have never seen this rate of attacks on health care, and health care becoming a target in these situations. It’s becoming part of the strategy and tactics of war and it is entirely unacceptable,” said Ryan. “Under international humanitarian law. conflicting parties are actually instructed to specifically take measures to avoid attacking or inadvertently destroying or hurting health workers or health facilities. They don’t bear responsibility not just to not attack. They actually bear responsibility to ensure that they don’t attack to identify those facilities, to deconflict those facilities and to ensure that they do not, as part of their prosecution of war, attack those facilities,” he added. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme. Multiple conflicts out of the global eye “Although Ukraine is the focus of the world’s attention, it’s far from the only crisis to which WHO is responding,” said Tedros. “In Yemen, roughly two-thirds of the population – more than 20 million people – are estimated to be in need of health assistance. In Afghanistan, more than half the population is in need, with widespread malnutrition and a surge in measles among many other challenges. “And in Ethiopia, six million people in Tigray have been under blockade by Ethiopian and Eritrean forces for almost 500 days, sealed off from the outside world. There is almost no fuel, no cash and no communications. No food aid has been delivered since the middle of December and 83% of the population is food insecure,” said Tedros, who is from Tigray and added his family and friends were affected by the blockade. Aid to Ukraine – but little for Tigray WHO Director-General Dr Tedros Adhanom Ghebreyesus. The WHO has been able to deliver about 100 metric tonnes of supplies to Ukraine, including oxygen, insulin, surgical supplies, anaesthetics and blood transfusion kits; oxygen generators, electrical generators and defibrillators. However, it had only received $8million of the $57.5 million it needed to support Ukraine. In contrast, however, it had only been able to airlift 33 metric tonnes of medicines and other supplies to Tigray in December – enough for 300,000 people – after being denied access to the territory since last July. “We estimate that 2,200 metric tonnes of emergency health supplies are needed to respond to urgent health needs in Tigray,” said Tedros. Treatment for 46,000 Tigrayan people living with HIV has been abandoned, as has treatment for people with cancer, diabetes, hypertension and tuberculosis. “The situation in Tigray is catastrophic. The blockade on communications, including on journalists being able to report from Tigray, means it remains a forgotten crisis. Out of sight and out of mind,” added Tedros. “Just as we continue to call on Russia to make peace in Ukraine, so we continue to call on Ethiopia and Eritrea to end the blockade, the siege, and allow safe access for humanitarian supplies and workers to save lives,” said Tedros. Global COVID-19 cases rise again Meanwhile, after weeks of global decline COVID-19 cases are on the rise again, especially in parts of Asia. “In the last week, we saw an 8% increase in cases detected with more than 11 million cases reported to WHO despite a significant reduction in testing that’s occurring worldwide,” said WHO COVID-19 lead Dr Maria van Kerkhove. She ascribed the increase to the spread of the Omicron variant – particularly the BA.2 lineage which is “the most transmissible variant we have seen of the SARS Co-V2 virus to date” – in a context where restrictions were being lifted globally. Ryan added that the virus would move from one “pocket of susceptibility” where immunity was waning to another. “The likelihood is that this virus will echo around the world,” said Ryan. “It will pick up pockets of susceptibility and will survive in those pockets for months and months until another pocket of susceptibility opens up,” said Ryan. “This is how viruses work. They establish themselves within a community and they will move quickly to the next community that’s unprotected. If communities around the virus are well protected, the virus can sustain itself, even in small communities. It can stay there, it can rest there, and then wait until susceptibility grows.” Image Credits: Markus Spiske/ Unsplash. WTO Head Welcomes Compromise on IP Waiver for COVID Vaccines – But Activists and Pharma Express Dismay 16/03/2022 Kerry Cullinan WTO members last week in session at the TRIPS Council, which has been debating a controversial proposal for an IP waiver on COVID products for over a year. The World Trade Organization’s (WTO) Director-Genera, Dr Ngozi Okonjo-Iweala has “warmly welcomed” the breakthrough reached this week over a waiver on intellectual property for the production of COVID-19 vaccines. “This is a major step forward and this compromise is the result of many long and difficult hours of negotiations. But we are not there yet. We have more work to do to ensure that we have the support of the entire WTO Membership,” said Okonjo-Iweala, in a statement on Wednesday. The agreement reached between the European Union, India, South Africa and the United States – referred to in some quarters as “the Quad” – still needs to be put to all 164 WTO members, which typically decides by consensus. However, the compromise now has good chances of being approved since EU countries had been the major opponents to the proposal by South Africa and India, submitted in October 2020, to waive IP on COVID-19 vaccines and other pandemic-related health products for the duration of the pandemic. Major concessions South Africa and India had to make major conceessions – both narrowing the waiver to only vaccines, as well as narrowing the list of countries that would be eligible to take advantage of the waiver on patents and other IP. “My team and I have been working hard for the past three months and we are ready to roll up our sleeves again to work together with the TRIPS Council Chair Ambassador Lansana Gberie (Sierra Leone) to bring about a full agreement as quickly as possible. We are grateful to the four Members for the difficult work they have undertaken so far,” said Okonjo-Iweala. The WTO’s Ministerial Council (MC12), postponed from late November to the week of June 13, could potentially approve the waiver move – although the date of that meeting has also been cast into doubt due to the recent outbreak of war in the Ukraine. However, the draft text of the proposed compromise, published by STAT News Tuesday evening, has elicited dismay from both health activists and the pharmaceutical industry – for not going far enough, or for going too far. Restricted to vaccines and certain developing countries In essence, the compromise does three things: Most critically, the new waiver would allow developing countries to not only manufacture, but also to export, generic versions of COVID vaccines that are still under patent protection. Currently, Article 31.f of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement restricts such generic manufacture to health products that are “predominantly for the supply of the domestic market” – leaving low-income countries with no manufacturing base unable to import cheaper generic versions of products from abroad. However, the waiver would be limited to countries that exported less than 10% of the world’s vaccines in 2021. That effectively excludes well-established manufacturers in China, but not India, from waiver eligibility. In contrast to the original Indian-South African proposal, the new IP flexibilities are restricted to COVID vaccines, thus excluding COVID treatments such as new antivirals that are particularly important for countries with low vaccination rates, as well as tests, personal protective equipment (PPE) and other pandemic-related goods. Adam Hodge, spokesperson for US Trade Representative Ambassador Katherine Tai, said late Tuesday that the “compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome” after a “difficult and protracted process”. Since last May @USTradeRep has worked hard to facilitate an outcome on IP that can achieve consensus across the 164 @WTO Members to help end the pandemic. USTR joined informal discussions led by the WTO Secretariat with South Africa, India, and the EU to try & break the deadlock. — USTR Office of Public Affairs (@USTRSpox) March 15, 2022 He and others cautioned that details of a final text were yet to be concluded. “While no agreement on text has been reached and we are in the process of consulting on the outcome, the US will continue to engage with WTO Members as part of our comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible,” added Hodge. The informal discussions, led by the WTO Secretariat, have been trying to break the deadlock between the India-South Africa waiver proposal (supported by the Africa and Least Developed Nations groups and others) and the EU’s counter-proposal. India-South Africa proposal had sought a broad waiver on all vaccines, tests and treatments, while the EU had pushed for technical modifications in the existing TRIPS rules. Medicines access activists and pharma leaders both express dismay Both activists and industry reacted with dismay to news of the proposed agreement. For example, the US-based consumer advocacy group, Public Citizen, called on WTO member states to reject the proposal. “Among its key limitations: the proposal appears to cover only vaccines (not tests and treatments), cover only patents (not other important intellectual property barriers), be limited geographically, and further undermine current WTO flexibilities for compulsory licenses,” according to Melinda St Louis, director of Public Citizen’s Global Trade Watch division. “It would be a mistake for WTO members to prematurely agree to a weakened waiver that provides political cover to the US and EU while not making any meaningful difference in increasing access to vaccines, tests and treatments. No waiver is better than a weak waiver designed solely to save face,” added St Louis. Knowledge Ecology International also expressed disquiet, saying that the waiver may even restrict certain flexibilities that are already allowed by Article 31 of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), regarding a country’s rights to manufacture and export generic versions of drugs or vaccines during a health emergency. “Countries are required to follow Article 31 of the TRIPS [agreement], which of course, is an existing and not a new flexibility, but with ‘clarifications’,” noted KEI’s Director, James Love. However, those “clarifications”, also come with new obligations that could make Article 31 “more restrictive and burdensome”, such as a new obligation for a country to identify all of the patents to which it is applying an IP waiver, and to notify the WTO of its use of the waiver – something not required for the issuance of compulsory licenses in general. On the other hand, the draft agreement makes a first-ever reference to a 2005 WHO/UNDP guidance on payments by developing countries to the original patent-holder, which embraces the concept of “tiered royalties”, based on a country’s ability to pay, and authored by Love himself. Pharma says agreement sends ‘wrong signal’ Meanwhile, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said that “weakening patents now when it is widely acknowledged that there are no longer supply constraints of COVID-19 vaccines, sends the wrong signal”. “When the IP TRIPS Waiver was first proposed in 2020, it was to the wrong solution to the problem of scaling up manufacturing of potential COVID-19 vaccines which at the time had not yet even been authorized,” said the IFPMA. “Now the problem of supply has been addressed thanks to unprecedented collaboration involving companies from industrialized and developing countries, the TRIPS Waiver is not only the wrong solution, it is also an outdated proposal, that has been overtaken by events.” It added that the TRIPS waiver proposal is “political posturing that are at best a distraction, at worse creating uncertainty that can undermine innovation’s ability to respond to the current and future response to pandemics”. “The current proposals should be shelved; and the focus should be directed, to admittedly more difficult actions that will change lives for the better: supporting country readiness, contributing to equitable distribution, and driving innovation,” the IFPMA concluded. The final text of any agreement would first need to be approved by the WTO TRIPS Council, and then go before the MC12 for final approval. The TRIPS Council last met on 9-10 March, but at the time failed to reach a compromise – although some sources noted that the were close to agreement as the “Quad” of India, South Africa, the United States and the EU scrambled to reach a deal. According to a WTO statement on 10 March, the TRIPS Council had agreed to keep the agenda item on the IP waiver open – so as to enable the council to be “reconvened at short notice if substantial progress is made in the high-level talks”. TRIPS Council approval would pave the way for a consensus agreement at the WTO’s Ministerial meeting, MC12. Russian Soldiers Hold Health Workers and Patients Hostage at Mariupol Hospital, says Human Rights Group 15/03/2022 Kerry Cullinan Mariupol Regional Hospital before it was bombed Health workers, patients and civilians have been held hostage at the Mariupol regional intensive care hospital in Ukraine by Russian troops since Monday morning, according to the Media Initiative for Human Rights (MIHR). Russian soldiers are using the hospital as a base to attack Ukrainian forces, and using the hostages as “human shields” according to MIHR, a respected human rights monitoring group in Ukraine. “We received information from a doctor from the hospital. We can’t name him because of the threat to him. More information will be available after the person is safe,” the MIHR reported on its Facebook page. Pavlo Kyrylenko, head of the Donetsk regional administration, also reported the hostage situation on his Telegram account. Kyrylenko reported that a hostage had told him: “It is impossible to leave the hospital. There is heavy shelling. We sit in the basement. Cars have not been able to drive into the hospital for two days. High-rise buildings are burning around… Russians rushed 400 people from neighbouring houses to our hospital. We can’t leave. “ While the 550-bed tertiary hospital, the biggest in the Donetsk region, has suffered extensive damage, health workers have continued to attend to patients from the basement. “I appeal to international human rights organizations to respond to these vicious violations of the norms and customs of war, to these egregious crimes against humanity,” said Kyrylenko. Humanitarian groups have been appealing for days for a safe passage corridor to and from Mariupol. Some private cars were finally able to leave the city on Monday and Tuesday, the first time in 10 days. But Russian troops that have beseiged the city on all sides have not allowed relief workers to bring in desperately needed medical supplies, food or water. Mariupol. Direct strike of Russian troops at the maternity hospital. People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror? Close the sky right now! Stop the killings! You have power but you seem to be losing humanity. pic.twitter.com/FoaNdbKH5k — Volodymyr Zelenskyy / Володимир Зеленський (@ZelenskyyUa) March 9, 2022 Last week, Russian troops bombed the Mariupol maternity hospital, reportedly killing at least three people. A pregnant woman evacuated from the hospital and her baby later died from their injuries. Mariupol’s deputy mayor, Sergey Orlov, told France24 on Tuesday that at least 2,358 people had been killed during the 11-day siege of the south-eastern city, and he had been fielding desperate calls from people trapped in basements without food or water. While small numbers of people escaped the besieged city on Monday after a series of failed evacuation attempts, as many as 2,500 civilians have died in Mariupol, Ukrainian officials estimate https://t.co/1ksWTFnzaf — CNN International (@cnni) March 15, 2022 ‘Act of unconscionable cruelty’ The World Health Organization (WHO) has verified 31 attacks on health facilities between the start of the Russian invasion on 24 February and 11 March, resulting in 12 deaths and 34 injuries, of which 8 of the injured and 2 of those killed were health workers. My hometown Volnovakha. I was born at this hospital. Now it’s officially denazified and liberated by Russia. pic.twitter.com/nV9lyZX4uQ — Illia Ponomarenko 🇺🇦 (@IAPonomarenko) March 15, 2022 “We call for an immediate cessation of all attacks on health care in Ukraine. These horrific attacks are killing and causing serious injuries to patients and health workers, destroying vital health infrastructure and forcing thousands to forgo accessing health services despite catastrophic needs,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, UNICEF Executive Director Catherine Russell and UNFPA Executive Director Dr Natalia Kanem, in a joint statement on Sunday. “To attack the most vulnerable – babies, children, pregnant women, and those already suffering from illness and disease, and health workers risking their own lives to save lives – is an act of unconscionable cruelty,” they added. “We must be able to safely deliver emergency medical supplies – including those required for obstetric and neonatal care – to health centers, temporary facilities and underground shelters.” Intentionally attacking health facilities is prohibited under international humanitarian law. Unusual position of surrogates Since the start of the war, more than 4,300 Ukrainian women have given birth, and 80,000 others are expected to give birth in the next three months. “Oxygen and medical supplies, including for the management of pregnancy complications, are running dangerously low,” according to the three leaders. “Many pregnant women may need health care, medication and assistance on a daily basis or when complications with pregnancy occur. When medical facilities are not accessible, are destroyed, or health care personnel and medical product are scarce or unavailable, maternal health can be endangered,” according to Eszther Kisomodi and Emma Pitchford, the chief executive and executive editor respectively of the journal, Sexual and Reproductive Health Matters. They also warned that many pregnant women might be in “particular and unusual situations” as Ukraine “is an international surrogacy hub, one of only a handful of countries in the world that legally allows foreigners to enter into surrogacy arrangements”. https://twitter.com/thedalstonyears/status/1501861609446289410 “Being a surrogate is a job in Ukraine for many women, but not one that they can quit, or even put on hold. Very serious questions occur for all parties in this arrangement – for the pregnant women, the newborn child and the intended parents.” The authors also highlight the precarious position of people with disabilities who cannot move easily, LBGTQ people in the face of hostile Russian forces, and people living with HIV in Ukraine, which has the second-highest infection rate in Europe. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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UN Environment Programme Joins WHO Alliance to Advance One Health Approach 18/03/2022 Editorial team Safer and more sustainable food systems – from production to sales in food markets is key to a One-Health Approach. UN Environment has joined a three-way alliance with the Food and Agriculture Organization, the World Animal Health Organization (OIE), and WHO to advance “One-Health” solutions to both ecosystem degradation and pandemic threats, leaders of the four agencies said on Friday. The statement followed a meeting this week of the Tripartite FAO, WHO and OIE partnership – which now has become a “Quadripartite”. “The One Health approach aims to sustainably balance and optimize the health of people, animals, ecosystems and the wider environment,” said WHO in a press release. “It mobilizes multiple sectors, disciplines and communities to work together to foster well-being and tackle threats to health and ecosystems. And it addresses the collective need for clean water, energy and air, safe and nutritious food, action on climate change, and contributing to sustainable development.” The work of the newly expanded alliance will be focused on a One Health Joint Plan of Action, which includes six main action tracks: enhancing countries’ capacity to strengthen health systems under a One Health approach; reducing the risks from emerging or resurfacing zoonotic epidemics and pandemics; controlling and eliminating endemic zoonotic, neglected tropical or vector-borne diseases; strengthening the assessment, management and communication of food safety risks; curbing the silent pandemic of antimicrobial resistance (AMR) and better integrating the environment into the One Health approach. Increased awareness of One Health As the world enters the third year of the COVID-19 pandemic, with an estimated cost of $8 to 16 trillion, there is increased awareness and broad recognition of the importance of One Health as a long-term, viable and sustainable approach. The G7, G20 and UN Food Systems Summit have all given a nod to the approach, along with the increased references by WHO and its partners. But the hard work of reforming food systems, from production to markets, as well as halting related deforestation and ecosystem destruction, are much more formidable challenges that the organisations have barely begun to face. Last year saw the Tripartite implement a number of initial initiatives, including on antimicrobial resistance, a One Health High-Level Expert Panel, and guidance on better management – but not the banning – of wild animal sales in markets – in the wake of the COVID pandemic, whose origins may have emerged from the capture, transport and slaughter of SARS-CoV2 infected wild animals at the Wuhan, China market. Plan implementation the key challenge “Now the challenge is implementation: how do we translate our work on the ground to support our Members? And how do we mobilize funding and financing mechanisms to support the Joint Plan for Action?” said FAO Director QU Dongyu, handing over the chair of the Secretariat to WHO. WHO Director-General Tedros Adhanom Ghebreyesus, said: “We need to build a more comprehensive and coordinated One Health governance structure at global level. We need a strong workforce, committed political will, and sustained financial investment. We need to develop a more proactive way of communicating and engaging across sectors, disciplines and communities to elicit the change we need.” (WHO) Image Credits: Michael Casmir/Pierce Mill Media. Healthy Mouths, Healthy Planet 18/03/2022 Ihsane Ben Yahya, Nicolas Martin & Steven Mulligan Dental procedures produce a hefty amount of carbon emissions. In honour of World Oral Health Day, 20 March, three leading voices from the World Dental Federation highlight the unexpected linkages between the health of your mouth and that of the planet. It will come as a surprise to most people that the healthcare sector has a significant environmental impact. Healthcare systems are responsible for around 5% of global greenhouse gas emissions, of which oral healthcare is an important contributor. Indeed, if the healthcare sector was a country, it would be the fifth largest greenhouse gas emitter on the planet. Oral healthcare contributes to this environmental burden with air pollution arising from the release of CO2 associated with travel and transport, the incineration of waste, the greenhouse gas impact of anesthetic gases such as nitrous oxide and the high consumption of water. Specific to dentistry, the most routine procedures, all come with a hefty carbon price tag. Tooth-coloured fillings for instance, produce around 15 kilograms of CO2eq (carbon dioxide equivalent) per procedure, according to Public Health England, whose National Health Service has done some of the most extensive carbon footprint modeling of healthcare delivery in the world. A single root canal treatment, meanwhile, produces 23 kilograms of CO2eq, dentures between 58 and 71 kilograms CO2eq. Use of the anesthetic gas nitrous oxide (laughing gas), in a procedure, meanwhile, is responsible for 119 kilograms CO2eq. Nitrous oxide N2O, the most commonly used inhalation dental anesthetic, is a greenhouse gas with far more climate warming potential than CO2. Just one kilogram of nitrous oxide is equivalent to 298 kilogrammes of CO2 and 25 kilograms of methane – another powerful greenhouse gas. Meanwhile, silver amalgam fillings contain mercury. While more and more rarely used today, and still considered safe for dental treatments, there is an environmental impact through the release of residual mercury into sewage during procedures, as well as throughout its life cycle. Prevention is better than cure Ways to maintain good oral health. The dental industry has a collective responsibility to reduce these impacts – while also expanding access to oral healthcare. How can we do both? One simple solution is to look at how we can best minimize what we might label as “avoidable” oral procedures. Prevention is always better than cure and it is the most impactful and practical way of reducing the need for clinical interventions and their associated environmental impacts. This is best achieved through the promotion of good oral hygiene, a healthy diet and the avoidance of smoking. When treatment is required, oral healthcare also should focus on the provision of durable fillings, using high quality products and materials that will last longer and/or require fewer replacements. Legislation around water fluoridation for instance, complemented by targeted public health policies can help prevent tooth decay (caries) and ultimately cavities. The recent banning of TV and online advertising of junk food in the UK before 9pm is an indirect example of encouraging better diet. So too the campaign by UK footballer Marcus Rashford to promote healthier school lunches. At the same time, while many dental problems such as caries and periodontal (gum) disease are common preventable diseases, no amount of prevention can make them go away entirely. There will always be a need for accessible dental check-ups and treatments to facilitate good oral health. And it remains important to expand access to such treatments among disadvantaged groups as well as in many low- and middle-income countries so as to reduce inequalities in healthcare provision. Less trips to the dentist would also mean less travel and water consumption Dental procedures require a lot of water, which can be reduced by practicing good oral healthcare. Oral healthcare has higher levels of patient and staff transport than other medical specializations and this is partly due to the need for regular oral health maintenance, whereas other specializations tend only to treat illness. In the UK for instance, staff and patient commuting and travel accounts for approximately two thirds of all emissions from the oral healthcare sector and about eight per cent of the total UK NHS air pollution attributable to travel. This can be reduced significantly, through the maintenance of good oral health, that requires fewer interventions and consequently fewer trips to the dentist. Simple transport habit changes can have a great impact. For example, in October 2021 the Sustainability Committee at Harvard School of Dental Medicine (HSDM) implemented a `Step Challenge´ that encouraged staff, students and faculty to walk, or take public transport rather than drive during that month. They amassed over one million steps in total, preventing the release of approximately 0.28 metric tons of CO2. The practice of dentistry and personal oral healthcare is a significant consumer of water. As a conservative estimate, a bathroom tap delivers about four litres/minute. If we estimate that half the world population cleans their teeth once a day and runs the tap for one minute, the daily global water usage equates to 6,400 Olympic swimming pools. This figure is in addition to undocumented water consumption up and down the oral healthcare manufacturing and distribution supply chain. Reducing dental use of single use plastics and packaging Measures to reduce carbon footprint in dental offices. So what measures can be taken at the dentist office to reduce the carbon footprint of dentistry procedures that are nonetheless essential to good oral health? The use and consequent disposal of single use plastics for many procedures is one of the biggest contributors to the environmental footprint of healthcare generally – and that holds true for dentistry as well. Among single-use plastics, in fact it is the packaging in which the needles, gloves and other oral healthcare products are encased that is the single largest contributor to such waste in the dental industry, with over 90 % ending its life cycle in an incinerator or a landfill. A more thoughtful approach to the design of such packaging – from the plastics content, manufacture and transport, to the potential for reuse, recycling or biodegradability, is therefore one obvious starting point in reducing the carbon footprint of the typical dentist’s office. This is particularly important because packaging, as such, is not “contaminated” biomedical waste that needs special treatment, post-procedure. This requires greater engagement with consumers and waste management companies to segregate, collect and recycle uncontaminated clinical single use plastics (SUPs) as a valuable commodity. It also involves the design and development of more plastic items made from mono-polymer plastics that can be readily recycled. The Flexible Plastics Consortium which represents 34 European companies looking for better plastics content and design solutions for packaging is a good example of how this might work in practice. The United Kingdom’s Plastics Pact is another good example: it has set targets with the goal of 100% of plastic packaging to be reused, recycled or compostable by 2025. Major challenges in managing single use plastic waste from oral healthcare Many single use dental items end up in the waste bin, including gloves, aprons, masks. Once the box is opened, many of the everyday products used in dentistry are only briefly used and then end up in the waste bin. These single-use plastic (SUP) items range from personal protective equipment (aprons, gloves and masks) and other disposable sundries (the mouth-rinse cup or the dental suction tube). SUP biomedical waste requires more specialized management – since these are contaminated with blood and other bodily fluids from oral health procedures. The high safety and quality requirements for these products to be legally compliant, is often incompatible with recycling and materials recovery. The complex nature of items assembled from different plastics also makes recycling difficult, as does the prevailing view that plastic is simply waste and is not considered a valuable resource. Still there are many attempts at finding solutions around the world. These include incentivization schemes and professional education courses that can help manufacturers to design products that can be safely treated and reprocessed, as well as sensitizing dental practitioners to different waste streams, and the treatment they require. Initiatives like the development of a competency-based dental waste management course being undertaken at the Copperbelt University in Zambia are a step in the right direction. Even so, the lack of good technological solutions for the appropriate collection, disinfection/sterilization and subsequent recovery or reprocessing of single use plastics used in biomedical procedures remains an ongoing barrier. We need product research to come up with safe, sustainable solutions for a circular economy, including in the healthcare sector, and governments to adopt supportive policies. Assessing the environmental impacts of oral healthcare as a first step It is important to understand the environmental impacts of materials used in healthcare. A better understanding of the environmental impacts of products and materials used in healthcare systems, from procurement to disposal, is key to any of these measures. Solutions proposed have included more life cycle analysis for all materials used in the healthcare supply chain and the development of a credible ‘sustainability index’ to inform medical supply purchasers about the sustainability credentials of a product. The index could potentially include information on environmental sourcing, ethical manufacturing, supply chain distribution and procurement. This World Oral Health Day we can celebrate the fact that the oral health sector has recognised that it has a vital role to play in healthcare-related climate change mitigation. That is the first step. The next ones will be more challenging and will need ‘teeth’. The FDI World Dental Federation´s Code of Good Practice, which is to be launched later this year, following an extensive consultation with the sector, will be a good starting point for ensuring healthy mouths also help to produce a healthier planet. Steven Mulligan Nicolas Martin Ihsane Ben Yahya Ihsane Ben Yahya is the President of the FDI World Dental Federation and professor at the Dental University in Casablanca, Morocco. Nicolas Martin is the Chair of the FDI Sustainability in Dentistry Task Team. He is also Clinical Professor in Restorative Dentistry in the School of Clinical Dentistry, at the University of Sheffield, UK. Steven Mulligan is a Member of the FDI Sustainability in Dentistry Task Team. He is also a Clinical Lecturer in Restorative Dentistry in the School of Clinical Dentistry, at the University of Sheffield, UK. Image Credits: Mass Communication Specialist Seaman Apprentice Brian H. Abel/Flickr, FDI World Dental Federation , Jan Fidler/Flickr, World Dental Federation , Mass Communication Specialist 3rd Class Everett Allen/Flickr. From COVID to Humanitarian Crises – Medical Oxygen Needs More Prioritization for its Lifesaving Capacities 17/03/2022 Raisa Santos Lifesaving oxygen flows into the lungs of a COVID patient in Chernivtsi, southwest Ukraine before the start of the recent Russian invasion. Whether its due to COVID or conflict, oxygen supplies fall short in many parts of the world. From patients lying in the parking lots of hospitals, in the back seats of cars suffocating as their family members searched frantically for oxygen in India during its second wave of COVID last year, to the inability to receive emergency care amidst constant bombing and shelling in current war-torn Ukraine, global health experts and leaders are desperately searching for ways of improving the global oxygen supply. At a media briefing on the issue Thursday, speakers emphasized the need for both access to oxygen on the ground and more funding to the WHO co-sponsored Access to COVID-19 Tools Accelerator (ACT-A), which is attempting to beef up oxygen supplies in low and middle-income countries. “Oxygen has been treated for too long like a commodity, treated as something that must be delivered,” said WHO Executive Director of Health Emergencies Programme Dr Mike Ryan, speaking at the briefing, cosponsored by the Act Acccelerator and Unitaid. But “oxygen is a capability, not a commodity,” he stressed. Rethinking oxygen’s lifesaving capacities Mike Ryan, Executive Director, Health Emergencies Programme; World Health Organization Ryan and others made the case for rethinking oxygen as a health tool that requires not only a sustainable supply at a country level, but an entire ecosystem of supply and maintenance technology and infrastructure. Its role – and the chronic lack of capacity in many countries – has been underscored by COVID – and again in the very different setting of the Ukraine crisis – where the lack of access for people ranging from COVID patients to mothers in birth and children with pneumonia has prompted widespread alarm. Oxygen remains a critical component of the global COVID-19 response – 75% of patients hospitalized for COVID-19 can be treated with oxygen alone – without any further advanced care. Yet the current global supply of oxygen does not meet needs for both COVID-19 and other serious illnesses. “COVID didn’t cause [the oxygen shortage], COVID uncovered this. COVID laid bare, tore away the bandages from some very old wounds,” said Ryan. UNITAID Commits $56 million to boost access to global medical oxygen supply Robert Matiru, Chair, ACT-A Oxygen Emergency Taskforce & Director Programmes, Unitaid The ACT-A Strategic Plan and Budget for 2022 has identified a funding deficit of $1 billion for oxygen supplies worldwide for this year alone. As a first step to closing that gap, Unitaid has announced that it will invest $56 million to increase access to medical oxygen both for short-term needs related to COVID-19 as well as for the longer term – as a critical foundation for fighting future pandemics. The Unitaid pledge builds on the $50 million USAID has committed in funding for oxygen as pledged at US President Joe Biden’s Global COVID-19 Summit in September 2021. Four Unitaid-funded projects, designed to address global inequities in oxygen access, will be implemented by The Alliance for International Medical Action (ALIMA), the Clinton Health Access Initiative (CHAI), Partners in Health (PIH), and the WHO Health Emergencies Programme. These will also support the work of the ACT-A Oxygen Emergency Task Force by ensuring access to more affordable oxygen solutions such as bulk liquid oxygen, oxygen generation systems, and other important oxygen equipment. Unitaid called on donors, including governments, foundations, and private sector partners to join in the efforts. “Our call here is not just for the present, for this pandemic, but to recognize that donors and funders that come forward and step forward, over and above the generous contributors to date, will help drive a more sustainable ecosystem and [deliver] essential medicines to countries that are lacking it,” said Robert Matiru, Chair of the ACT-A Oxygen Emergency Taskforce and Director of Programmes at Unitaid. Children with pneumonia unrecognized victims – 40% of hospitals in some African countries lack oxygen Numerous countries are facing oxygen shortages, while readily available oxygen products are in short supply. Children are among the unrecognized victims of the lack of oxygen supplies – with childhood pneumonia still one of the biggest killers of under-fives. Accounting for almost a million deaths a year, the highest burden is in sub-Saharan African and South-East Asian countries where children face a double whammy of disease from both the lack of preventive treatments, like vaccinations, along with exposure to heavy indoor air pollution from the open burning of coal, biomass and other such fuels. But an estimated 20 to 40% of these deaths are preventable with increased availability of oxygen therapy. The shortage is particularly acute in low-income sub-Saharan African countries such as Tanzania, Sierra Leone, Liberia, and Gambia, where 40% of health facilities had no access to oxygen and other basic life saving supplies, said Atul Gawande of the United States Agency for International Development (USAID). COVID has led to big surges in needs Daily medical oxygen need for COVID-19 as of 16 March 2022 Along with the chronic shortages, COVID led to a major surge in oxygen needs. Low and middle-income countries (LMICs) need at least 23 million cubic meters of oxygen every day, just to treat COVID patients alone, according to the PATH COVID-19 Oxygen Needs Tracker. On the brighter side, the pandemic has brought a long-ignored aspect of health capacity in LMICs more to the forefront. USAID is currently working in 11 countries to build ‘oxygen ecosystems’ to support oxygen therapy for pneumonia patients, COVID patients, and others, Gawande said. Countries like Ghana now have oxygen generating capacity that can support up to 300,000 patients per day, per year. Gawande noted that the oxygen ecosystem includes liquid oxygen cylinders and concentrators, as well as the clinical engineering and technical assistance to use the technology. But expanding this initiative to other countries still needs more funding. Atul Gawande, USAID “As the Omicron variant abates, I think we’re all starting to feel that we can catch our breath. Oxygen demand may be lower right now. But it is the time that we have to make these investments to enable this kind of [sustainable] capacity.” Gawande said. Oxygen ‘natural security’ and ‘high-return’ health investment Leith Greenslade, Founder/CEO, JustActions & Coordinator, Every Breath Counts Coalition While the recent funding commitments are a positive sign, ‘it is not enough to fund protection’, said Leith Greenslade of the Every Breath Counts Coalition. “It took a pandemic of respiratory infection to wake up the world,” she pointed out. In the past year, about $700 million was invested into the ACT-A Oxygen Emergency Task Force, which has worked in LMICs to prevent oxygen shortages – jump-starting a more focused response. But so far, only a handful of governments – including the United States, Germany, Canada, and France – have borne the funding burden. “But most of the G-20 nations have not stepped up to invest in oxygen,” she charged. Greenslade appealed to donors to see oxygen as a high priority for three reasons: the moral obligation to flatten the COVID-19 curve; oxygen as a “national security” issue in moments of crisis; and finally, oxygen as a high-return health investment that will keep on saving lives beyond the pandemic. “When hospitals run out of oxygen, we have seen strikes and civil unrest in quite a few low- and middle-income countries,” she pointed out. “How many more deaths before this is over will largely depend on access to oxygen and critical care in the countries where the disease is greatest and the health systems are weakest,” she declared. Image Credits: Mstyslav Chernov/ Wikimedia Commons, UNICEF/Ralaivita, PATH, Every Breath Counts . Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates 17/03/2022 Elaine Ruth Fletcher Pfizer’s Paxlovid, an oral antiviral approved by the US FDA in December, has shown 90% efficacy in preventing mortality among those who take it in the first few days of infection. A Medicines Patent Pool (MPP) announcement Thursday that it has signed agreements with 35 companies to manufacture generic versions of Pfizer’s life-saving COVID-19 Paxlovid treatment for distribution in 95 low- and middle-income countries came fire almost immediately from medicines access groups as too little, too late. The MPP-brokered sublicences follow on from an agreement between MPP and Pfizer in November 2021 to supply generic versions of Pfizer patented main drug ingredient, nirmatrelvir, at cost, to countries that represent about 53% of the world’s population. However, activists quickly slammed with the new accord – saying that it would take up many months to actually set up the generic production lines of the game-changing oral drug, which in clinical trials, reduced COVID mortality by 90% among high risk groups. Mapping of the MPP-brokered licenses awarded for manufacture of a generic version of Paxlovid In a joint letter to Pfizer CEO Albert Bourla, delivered Wednesday, a consortium of 100 activist groups, including Amnesty International and Oxfam, said that Pfizer should immediately dedicate two-thirds of the company’s available patented drug supply to low- and middle-income countries, “where there is a proportionate need.” “At present, Pfizer has preferentially sold all of its Paxlovid doses from the first half of 2022 to a handful of high-income countries, and has tentatively promised to supply only 10 million courses of treatment of LMICs,” stated the Health Global Access Project (Health Gap), one of the signatories to Wednesday’s letter, in a follow-up blog posted online just after the MPP announcement. The activists also have slammed the still high price of the new drug in upper-middle and high income countries, saying that this also creates barriers to access. The United States is paying about $530 a day for a five-day course, although Pfizer has committed to a 3-tiered pricing system with lower costs to less affluent countries. “This announcement will do nothing to eliminate the monopoly Pfizer maintains over unlicensed countries – all high-income and almost all upper-middle income countries, representing 47% of the world’s population and historically experiencing the highest rates of COVID-19 infection,” added Brook Baker, Health Gap Senior Policy Analyst and a Professor at Northeastern University School of Law. MSF – A ‘positive step’ forward Médecins Sans Frontières sounded a more positive note, however, saying that the Pfizer agreement with 35 generics manufacturers in 12 countries represents a “positive step toward addressing the ongoing access challenges for this COVID treatment. However, the limitations of the deal remain concerning.” “The limited global supply from the US corporation Pfizer has so far largely been bought up by a number of high-income countries. It is estimated that generic manufacturers will not be able to bring supply to the market until 2023,” stated MSF. Replying to the criticism, an MPP spokesperson stressed that the new agreement “includes all low and lower-middle-income countries as well as some upper-middle income countries in Sub-Saharan Africa that have transitioned to upper-middle-income status in the past five years. The 53% of the world’s population covered by the licenses, “which is equivalent to about 4.1 billion people. As with all our licences we will continue to explore opportunities to broaden geographic scope, where possible,” the MPP spokesperson added. Design of MPP agreement According to MPP, the non-exclusive sublicence deals will allow generic manufacturers to produce the raw ingredients for Paxlovid’s main active ingredient, nirmatrelvir, and/or the finished drug itself, which is co-packaged with a common HIV drug, ritonavir. It said that six companies will focus on producing the drug substance, nine companies will produce the finished drug product and the remainder will do both. The manufacturers are based in 12 countries including: Bangladesh, Brazil, China, Dominican Republic, Jordan, India, Israel, Mexico, Pakistan, Serbia, Republic of Korea, and Vietnam. “A licence has also been offered to a company in Ukraine, the offer will remain available to them as they are not able to sign due to the current conflict,” MPP said. The deal signed between MPP and Pfizer in November 2021 established the terms and conditions, for the generic licenses, MPP added. Following that, “The requests for sublicences from generic producers were reviewed by MPP and presented to Pfizer,” for its approval – one of the conditions of the sale. Pfizer will not receive royalties from sales of nirmatrelvir from the MPP-negotiated sublicensees for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization, MPP added. Following the pandemic period, sales to low-income countries will remain royalty free, lower-middle-income countries and upper-middle-income countries will be subject to a 5% royalty for sales to the public sector and a 10% royalty for sales to the private sector. “Nirmatrelvir is a new product and requires substantial manufacturing capabilities to produce, and we have been very impressed with the quality of manufacturing demonstrated by these companies,” said Charles Gore, MPP Executive Director. “Furthermore, 15 companies are signing their first licence with MPP, and we warmly welcome our new generic manufacturing partners.” “We have established a comprehensive strategy in partnership with worldwide governments, international global health leaders and global manufacturers to help ensure access to our oral COVID-19 treatment for patients in need around the world, said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “The MPP sublicensees and the additional capacity for COVID-19 treatment they will supply will play a critical role to help ensure that people everywhere, particularly those living in the poorest parts of the world, have equitable access to an oral treatment option against COVID-19.” Image Credits: Pfizer , Medicines Patent Pool . Fourth COVID Vaccine Jab Provides Little Extra Protection to Healthy Individuals – NEJM 16/03/2022 Maayan Hoffman A month after a fourth dose of the Pfizer or Moderna vaccines was administered to hundreds of people in an Israeli clinical trial, authors of the new study on the extra booster say it provides “little protection, if any, from infection by COVID-19 among vaccinated young and healthy individuals in comparison to those vaccinated with only a third dose.” Result of the open-label study, conducted at Israel’s Sheba Medical Center, were published Wednesday evening in the New England Journal of Medicine as a correspondence. The findings contradict statements made by Pfizer CEO Albert Bourla over the weekend that a fourth booster dose could necessary for most people, due to waning immunity. Bourla made the statement as Pfizer seeks quick US Food and Drug Administration approval of a fourth dose, effectively a second booster, for people 65 and older. The new Sheba study included approximately 600 volunteers, among them 270 who received a fourth shot of either the Moderna or Pfizer vaccine. All of the volunteers had received three shots of the Pfizer vaccine prior to the trial. Sheba’s Professor Gili Regev-Yochay, lead author of the study, said in a statement that COVID infection rates among four-time vaccinated individuals were only slightly lower than those in the control group. However, she added that the fourth jab did provide moderate protection against symptomatic infection among young and healthy individuals, in comparison to those who had only received three jabs. “We found no differences, both in terms of IgG antibody levels and in terms of neutralizing antibody levels,” added Regev-Yochay, referring to the impact of the fourth jab on the study group in comparison to the control. “It should be emphasized that the third dose is extremely important for anyone who has not yet contracted COVID-19,” Regev-Yochay stressed, “and the fourth dose is most likely important for populations with risk factors, for which a fourth vaccine would protect from serious illness.” The NEJM correspondence, however, said that the fourth dose was “immunogenic, safe and somewhat efficacious”, adding that “our results suggest that maximal immunogenicity of mRNA vaccines is achieved after three doses and that antibody levels can be restored by a fourth dose.” The researchers added that they observed “low vaccine efficacy against infections in health care workers, as well as relatively high viral loads suggesting that those who were infected were infectious.” Bourla: Fourth shot ‘necessary’ The release of the data comes at an awkward time for Pfizer, after a weekend when Bourla said in an interview with CBS’s Face the Nation that a fourth COVID-19 shot would be “necessary” for most people to prevent future infection. Pfizer CEO Albert Bourla in a CBS interview on March 13, 2022. “Right now, the way that we have seen, it is necessary, a fourth booster right now,” Bourla said in the interview. “The protection that you are getting from the third, it is good enough, actually quite good for hospitalizations and deaths. It’s not that good against infections, but doesn’t last very long.” While Bourla said Pfizer had submitted data on the efficacy of the fourth shot to the US FDA, the data has not yet been publicly released. 1. A fourth dose of the Covid-19 vaccine is necessary for most people due to waning immunity, said Pfizer CEO Albert Bourla. He noted that the regimen of two doses plus a booster is not able to offer sufficient protection against new variants. pic.twitter.com/XPCFwiqluD — BFM News (@NewsBFM) March 14, 2022 The US Centers for Disease Control and Prevention currently recommends three jabs for everyone age 12 years and up, and two shots for children between the ages of five and 11. Individuals who are immunocompromised are encouraged to get an extra dose. Fourth dose still protects against severe infection, separate study found A separate Israeli study published, on February 1 by the Israeli Health Ministry, offered somewhat contradictory results to the Sheba findings – although the Ministry of Health study focused only on older people. That study, released on the pre-print biomedical website MedRXiv, found that rates of confirmed COVID-19 infection, as well as severe illness, were lower following a fourth dose, when compared to only three doses. Specifically, the team looked at data from 1,138,681 persons aged over 60 years and eligible for the fourth dose between January 15 and 27, 2022 – the height of the Omicron wave in Israel. They compared the rate of confirmed COVID infections and severe COVID illness between those who took a fourth jab at least 12 days earlier and those who only had three doses, or alternatively those who became ill less than a week after receiving the fourth dose. “The rate of confirmed infection was lower in people 12 or more days after their fourth dose than among those who received only three doses and those 3 to 7 days after vaccination by factors of 2.0 and 1.9, respectively. The rate of severe illness was lower by factors of 4.3 and 4.0,” the authors wrote. ‘Vaccines don’t prevent infection’ Professor Cyrille Cohen, head of the immunology lab at Bar-Ilan University, said that the findings from the Sheba study are not surprising; “the vaccines are not good enough to prevent infection, and even more so with the Omicron variant,” he said. However, like Regev-Yochay, Cohen stressed that there is a growing body of data that shows there remains a substantial difference in the levels of protection acquired by people who are vaccinated with two doses and those who get three doses, when it comes to developing severe disease. “Look at the ratio between people age 60 who got three doses and people that were not vaccinated and got two doses. Even with Omicron, the third dose can reduce the chance of developing severe disease by a factor of four or five and for people above 60 that number becomes 10 to 20,” Cohen said. He also noted that a fourth dose also may help the most vulnerable, noting that today, the serious cases in Israel still tend to be older people with comorbidities or unvaccinated people. “Based on that, a fourth dose for selected populations might demonstrate a benefit,” he said. When asked about Bourla’s statement, Cohen said “it was not clear” and that perhaps the Pfizer CEO was referring to people receiving a shot of the Omicron-adapted vaccine, for which data has not yet been released. A multi-country clinical trial of that vaccine is now underway, including a trial arm in Israel. “I am personally extremely curious to see those results,” Cohen said. Image Credits: Screenshot. Attacks on Health Facilities Are Becoming ‘Part of War Strategy’ in Conflict Zones, Warns WHO 16/03/2022 Kerry Cullinan Attacks on health facilities appear to be part of a deliberate war strategy in Ukraine and other recent conflicts, according to the head of the World Health Organization (WHO) health emergencies programme. The WHO has verified 43 attacks on Ukrainian health facilities since Russia’s invasion on 24 February – and it expects further attacks as over 300 health facilities in conflict areas or under Russian control and a further 600 facilities within 10 kilometres of conflict. But WHO Director-General Dr Tedros Adhanom Ghebreyesus told a media briefing on Wednesday that there had also been 46 attacks on health facilities worldwide since the start of 2022, and people caught in conflicts in Tigray, Yemen and Syria were in extreme need of humanitarian assistance. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme, said that in these conflict zones, attacks on health facilities appeared to be deliberate – in complete violation of international law. “We have never seen this rate of attacks on health care, and health care becoming a target in these situations. It’s becoming part of the strategy and tactics of war and it is entirely unacceptable,” said Ryan. “Under international humanitarian law. conflicting parties are actually instructed to specifically take measures to avoid attacking or inadvertently destroying or hurting health workers or health facilities. They don’t bear responsibility not just to not attack. They actually bear responsibility to ensure that they don’t attack to identify those facilities, to deconflict those facilities and to ensure that they do not, as part of their prosecution of war, attack those facilities,” he added. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme. Multiple conflicts out of the global eye “Although Ukraine is the focus of the world’s attention, it’s far from the only crisis to which WHO is responding,” said Tedros. “In Yemen, roughly two-thirds of the population – more than 20 million people – are estimated to be in need of health assistance. In Afghanistan, more than half the population is in need, with widespread malnutrition and a surge in measles among many other challenges. “And in Ethiopia, six million people in Tigray have been under blockade by Ethiopian and Eritrean forces for almost 500 days, sealed off from the outside world. There is almost no fuel, no cash and no communications. No food aid has been delivered since the middle of December and 83% of the population is food insecure,” said Tedros, who is from Tigray and added his family and friends were affected by the blockade. Aid to Ukraine – but little for Tigray WHO Director-General Dr Tedros Adhanom Ghebreyesus. The WHO has been able to deliver about 100 metric tonnes of supplies to Ukraine, including oxygen, insulin, surgical supplies, anaesthetics and blood transfusion kits; oxygen generators, electrical generators and defibrillators. However, it had only received $8million of the $57.5 million it needed to support Ukraine. In contrast, however, it had only been able to airlift 33 metric tonnes of medicines and other supplies to Tigray in December – enough for 300,000 people – after being denied access to the territory since last July. “We estimate that 2,200 metric tonnes of emergency health supplies are needed to respond to urgent health needs in Tigray,” said Tedros. Treatment for 46,000 Tigrayan people living with HIV has been abandoned, as has treatment for people with cancer, diabetes, hypertension and tuberculosis. “The situation in Tigray is catastrophic. The blockade on communications, including on journalists being able to report from Tigray, means it remains a forgotten crisis. Out of sight and out of mind,” added Tedros. “Just as we continue to call on Russia to make peace in Ukraine, so we continue to call on Ethiopia and Eritrea to end the blockade, the siege, and allow safe access for humanitarian supplies and workers to save lives,” said Tedros. Global COVID-19 cases rise again Meanwhile, after weeks of global decline COVID-19 cases are on the rise again, especially in parts of Asia. “In the last week, we saw an 8% increase in cases detected with more than 11 million cases reported to WHO despite a significant reduction in testing that’s occurring worldwide,” said WHO COVID-19 lead Dr Maria van Kerkhove. She ascribed the increase to the spread of the Omicron variant – particularly the BA.2 lineage which is “the most transmissible variant we have seen of the SARS Co-V2 virus to date” – in a context where restrictions were being lifted globally. Ryan added that the virus would move from one “pocket of susceptibility” where immunity was waning to another. “The likelihood is that this virus will echo around the world,” said Ryan. “It will pick up pockets of susceptibility and will survive in those pockets for months and months until another pocket of susceptibility opens up,” said Ryan. “This is how viruses work. They establish themselves within a community and they will move quickly to the next community that’s unprotected. If communities around the virus are well protected, the virus can sustain itself, even in small communities. It can stay there, it can rest there, and then wait until susceptibility grows.” Image Credits: Markus Spiske/ Unsplash. WTO Head Welcomes Compromise on IP Waiver for COVID Vaccines – But Activists and Pharma Express Dismay 16/03/2022 Kerry Cullinan WTO members last week in session at the TRIPS Council, which has been debating a controversial proposal for an IP waiver on COVID products for over a year. The World Trade Organization’s (WTO) Director-Genera, Dr Ngozi Okonjo-Iweala has “warmly welcomed” the breakthrough reached this week over a waiver on intellectual property for the production of COVID-19 vaccines. “This is a major step forward and this compromise is the result of many long and difficult hours of negotiations. But we are not there yet. We have more work to do to ensure that we have the support of the entire WTO Membership,” said Okonjo-Iweala, in a statement on Wednesday. The agreement reached between the European Union, India, South Africa and the United States – referred to in some quarters as “the Quad” – still needs to be put to all 164 WTO members, which typically decides by consensus. However, the compromise now has good chances of being approved since EU countries had been the major opponents to the proposal by South Africa and India, submitted in October 2020, to waive IP on COVID-19 vaccines and other pandemic-related health products for the duration of the pandemic. Major concessions South Africa and India had to make major conceessions – both narrowing the waiver to only vaccines, as well as narrowing the list of countries that would be eligible to take advantage of the waiver on patents and other IP. “My team and I have been working hard for the past three months and we are ready to roll up our sleeves again to work together with the TRIPS Council Chair Ambassador Lansana Gberie (Sierra Leone) to bring about a full agreement as quickly as possible. We are grateful to the four Members for the difficult work they have undertaken so far,” said Okonjo-Iweala. The WTO’s Ministerial Council (MC12), postponed from late November to the week of June 13, could potentially approve the waiver move – although the date of that meeting has also been cast into doubt due to the recent outbreak of war in the Ukraine. However, the draft text of the proposed compromise, published by STAT News Tuesday evening, has elicited dismay from both health activists and the pharmaceutical industry – for not going far enough, or for going too far. Restricted to vaccines and certain developing countries In essence, the compromise does three things: Most critically, the new waiver would allow developing countries to not only manufacture, but also to export, generic versions of COVID vaccines that are still under patent protection. Currently, Article 31.f of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement restricts such generic manufacture to health products that are “predominantly for the supply of the domestic market” – leaving low-income countries with no manufacturing base unable to import cheaper generic versions of products from abroad. However, the waiver would be limited to countries that exported less than 10% of the world’s vaccines in 2021. That effectively excludes well-established manufacturers in China, but not India, from waiver eligibility. In contrast to the original Indian-South African proposal, the new IP flexibilities are restricted to COVID vaccines, thus excluding COVID treatments such as new antivirals that are particularly important for countries with low vaccination rates, as well as tests, personal protective equipment (PPE) and other pandemic-related goods. Adam Hodge, spokesperson for US Trade Representative Ambassador Katherine Tai, said late Tuesday that the “compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome” after a “difficult and protracted process”. Since last May @USTradeRep has worked hard to facilitate an outcome on IP that can achieve consensus across the 164 @WTO Members to help end the pandemic. USTR joined informal discussions led by the WTO Secretariat with South Africa, India, and the EU to try & break the deadlock. — USTR Office of Public Affairs (@USTRSpox) March 15, 2022 He and others cautioned that details of a final text were yet to be concluded. “While no agreement on text has been reached and we are in the process of consulting on the outcome, the US will continue to engage with WTO Members as part of our comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible,” added Hodge. The informal discussions, led by the WTO Secretariat, have been trying to break the deadlock between the India-South Africa waiver proposal (supported by the Africa and Least Developed Nations groups and others) and the EU’s counter-proposal. India-South Africa proposal had sought a broad waiver on all vaccines, tests and treatments, while the EU had pushed for technical modifications in the existing TRIPS rules. Medicines access activists and pharma leaders both express dismay Both activists and industry reacted with dismay to news of the proposed agreement. For example, the US-based consumer advocacy group, Public Citizen, called on WTO member states to reject the proposal. “Among its key limitations: the proposal appears to cover only vaccines (not tests and treatments), cover only patents (not other important intellectual property barriers), be limited geographically, and further undermine current WTO flexibilities for compulsory licenses,” according to Melinda St Louis, director of Public Citizen’s Global Trade Watch division. “It would be a mistake for WTO members to prematurely agree to a weakened waiver that provides political cover to the US and EU while not making any meaningful difference in increasing access to vaccines, tests and treatments. No waiver is better than a weak waiver designed solely to save face,” added St Louis. Knowledge Ecology International also expressed disquiet, saying that the waiver may even restrict certain flexibilities that are already allowed by Article 31 of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), regarding a country’s rights to manufacture and export generic versions of drugs or vaccines during a health emergency. “Countries are required to follow Article 31 of the TRIPS [agreement], which of course, is an existing and not a new flexibility, but with ‘clarifications’,” noted KEI’s Director, James Love. However, those “clarifications”, also come with new obligations that could make Article 31 “more restrictive and burdensome”, such as a new obligation for a country to identify all of the patents to which it is applying an IP waiver, and to notify the WTO of its use of the waiver – something not required for the issuance of compulsory licenses in general. On the other hand, the draft agreement makes a first-ever reference to a 2005 WHO/UNDP guidance on payments by developing countries to the original patent-holder, which embraces the concept of “tiered royalties”, based on a country’s ability to pay, and authored by Love himself. Pharma says agreement sends ‘wrong signal’ Meanwhile, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said that “weakening patents now when it is widely acknowledged that there are no longer supply constraints of COVID-19 vaccines, sends the wrong signal”. “When the IP TRIPS Waiver was first proposed in 2020, it was to the wrong solution to the problem of scaling up manufacturing of potential COVID-19 vaccines which at the time had not yet even been authorized,” said the IFPMA. “Now the problem of supply has been addressed thanks to unprecedented collaboration involving companies from industrialized and developing countries, the TRIPS Waiver is not only the wrong solution, it is also an outdated proposal, that has been overtaken by events.” It added that the TRIPS waiver proposal is “political posturing that are at best a distraction, at worse creating uncertainty that can undermine innovation’s ability to respond to the current and future response to pandemics”. “The current proposals should be shelved; and the focus should be directed, to admittedly more difficult actions that will change lives for the better: supporting country readiness, contributing to equitable distribution, and driving innovation,” the IFPMA concluded. The final text of any agreement would first need to be approved by the WTO TRIPS Council, and then go before the MC12 for final approval. The TRIPS Council last met on 9-10 March, but at the time failed to reach a compromise – although some sources noted that the were close to agreement as the “Quad” of India, South Africa, the United States and the EU scrambled to reach a deal. According to a WTO statement on 10 March, the TRIPS Council had agreed to keep the agenda item on the IP waiver open – so as to enable the council to be “reconvened at short notice if substantial progress is made in the high-level talks”. TRIPS Council approval would pave the way for a consensus agreement at the WTO’s Ministerial meeting, MC12. Russian Soldiers Hold Health Workers and Patients Hostage at Mariupol Hospital, says Human Rights Group 15/03/2022 Kerry Cullinan Mariupol Regional Hospital before it was bombed Health workers, patients and civilians have been held hostage at the Mariupol regional intensive care hospital in Ukraine by Russian troops since Monday morning, according to the Media Initiative for Human Rights (MIHR). Russian soldiers are using the hospital as a base to attack Ukrainian forces, and using the hostages as “human shields” according to MIHR, a respected human rights monitoring group in Ukraine. “We received information from a doctor from the hospital. We can’t name him because of the threat to him. More information will be available after the person is safe,” the MIHR reported on its Facebook page. Pavlo Kyrylenko, head of the Donetsk regional administration, also reported the hostage situation on his Telegram account. Kyrylenko reported that a hostage had told him: “It is impossible to leave the hospital. There is heavy shelling. We sit in the basement. Cars have not been able to drive into the hospital for two days. High-rise buildings are burning around… Russians rushed 400 people from neighbouring houses to our hospital. We can’t leave. “ While the 550-bed tertiary hospital, the biggest in the Donetsk region, has suffered extensive damage, health workers have continued to attend to patients from the basement. “I appeal to international human rights organizations to respond to these vicious violations of the norms and customs of war, to these egregious crimes against humanity,” said Kyrylenko. Humanitarian groups have been appealing for days for a safe passage corridor to and from Mariupol. Some private cars were finally able to leave the city on Monday and Tuesday, the first time in 10 days. But Russian troops that have beseiged the city on all sides have not allowed relief workers to bring in desperately needed medical supplies, food or water. Mariupol. Direct strike of Russian troops at the maternity hospital. People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror? Close the sky right now! Stop the killings! You have power but you seem to be losing humanity. pic.twitter.com/FoaNdbKH5k — Volodymyr Zelenskyy / Володимир Зеленський (@ZelenskyyUa) March 9, 2022 Last week, Russian troops bombed the Mariupol maternity hospital, reportedly killing at least three people. A pregnant woman evacuated from the hospital and her baby later died from their injuries. Mariupol’s deputy mayor, Sergey Orlov, told France24 on Tuesday that at least 2,358 people had been killed during the 11-day siege of the south-eastern city, and he had been fielding desperate calls from people trapped in basements without food or water. While small numbers of people escaped the besieged city on Monday after a series of failed evacuation attempts, as many as 2,500 civilians have died in Mariupol, Ukrainian officials estimate https://t.co/1ksWTFnzaf — CNN International (@cnni) March 15, 2022 ‘Act of unconscionable cruelty’ The World Health Organization (WHO) has verified 31 attacks on health facilities between the start of the Russian invasion on 24 February and 11 March, resulting in 12 deaths and 34 injuries, of which 8 of the injured and 2 of those killed were health workers. My hometown Volnovakha. I was born at this hospital. Now it’s officially denazified and liberated by Russia. pic.twitter.com/nV9lyZX4uQ — Illia Ponomarenko 🇺🇦 (@IAPonomarenko) March 15, 2022 “We call for an immediate cessation of all attacks on health care in Ukraine. These horrific attacks are killing and causing serious injuries to patients and health workers, destroying vital health infrastructure and forcing thousands to forgo accessing health services despite catastrophic needs,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, UNICEF Executive Director Catherine Russell and UNFPA Executive Director Dr Natalia Kanem, in a joint statement on Sunday. “To attack the most vulnerable – babies, children, pregnant women, and those already suffering from illness and disease, and health workers risking their own lives to save lives – is an act of unconscionable cruelty,” they added. “We must be able to safely deliver emergency medical supplies – including those required for obstetric and neonatal care – to health centers, temporary facilities and underground shelters.” Intentionally attacking health facilities is prohibited under international humanitarian law. Unusual position of surrogates Since the start of the war, more than 4,300 Ukrainian women have given birth, and 80,000 others are expected to give birth in the next three months. “Oxygen and medical supplies, including for the management of pregnancy complications, are running dangerously low,” according to the three leaders. “Many pregnant women may need health care, medication and assistance on a daily basis or when complications with pregnancy occur. When medical facilities are not accessible, are destroyed, or health care personnel and medical product are scarce or unavailable, maternal health can be endangered,” according to Eszther Kisomodi and Emma Pitchford, the chief executive and executive editor respectively of the journal, Sexual and Reproductive Health Matters. They also warned that many pregnant women might be in “particular and unusual situations” as Ukraine “is an international surrogacy hub, one of only a handful of countries in the world that legally allows foreigners to enter into surrogacy arrangements”. https://twitter.com/thedalstonyears/status/1501861609446289410 “Being a surrogate is a job in Ukraine for many women, but not one that they can quit, or even put on hold. Very serious questions occur for all parties in this arrangement – for the pregnant women, the newborn child and the intended parents.” The authors also highlight the precarious position of people with disabilities who cannot move easily, LBGTQ people in the face of hostile Russian forces, and people living with HIV in Ukraine, which has the second-highest infection rate in Europe. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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Healthy Mouths, Healthy Planet 18/03/2022 Ihsane Ben Yahya, Nicolas Martin & Steven Mulligan Dental procedures produce a hefty amount of carbon emissions. In honour of World Oral Health Day, 20 March, three leading voices from the World Dental Federation highlight the unexpected linkages between the health of your mouth and that of the planet. It will come as a surprise to most people that the healthcare sector has a significant environmental impact. Healthcare systems are responsible for around 5% of global greenhouse gas emissions, of which oral healthcare is an important contributor. Indeed, if the healthcare sector was a country, it would be the fifth largest greenhouse gas emitter on the planet. Oral healthcare contributes to this environmental burden with air pollution arising from the release of CO2 associated with travel and transport, the incineration of waste, the greenhouse gas impact of anesthetic gases such as nitrous oxide and the high consumption of water. Specific to dentistry, the most routine procedures, all come with a hefty carbon price tag. Tooth-coloured fillings for instance, produce around 15 kilograms of CO2eq (carbon dioxide equivalent) per procedure, according to Public Health England, whose National Health Service has done some of the most extensive carbon footprint modeling of healthcare delivery in the world. A single root canal treatment, meanwhile, produces 23 kilograms of CO2eq, dentures between 58 and 71 kilograms CO2eq. Use of the anesthetic gas nitrous oxide (laughing gas), in a procedure, meanwhile, is responsible for 119 kilograms CO2eq. Nitrous oxide N2O, the most commonly used inhalation dental anesthetic, is a greenhouse gas with far more climate warming potential than CO2. Just one kilogram of nitrous oxide is equivalent to 298 kilogrammes of CO2 and 25 kilograms of methane – another powerful greenhouse gas. Meanwhile, silver amalgam fillings contain mercury. While more and more rarely used today, and still considered safe for dental treatments, there is an environmental impact through the release of residual mercury into sewage during procedures, as well as throughout its life cycle. Prevention is better than cure Ways to maintain good oral health. The dental industry has a collective responsibility to reduce these impacts – while also expanding access to oral healthcare. How can we do both? One simple solution is to look at how we can best minimize what we might label as “avoidable” oral procedures. Prevention is always better than cure and it is the most impactful and practical way of reducing the need for clinical interventions and their associated environmental impacts. This is best achieved through the promotion of good oral hygiene, a healthy diet and the avoidance of smoking. When treatment is required, oral healthcare also should focus on the provision of durable fillings, using high quality products and materials that will last longer and/or require fewer replacements. Legislation around water fluoridation for instance, complemented by targeted public health policies can help prevent tooth decay (caries) and ultimately cavities. The recent banning of TV and online advertising of junk food in the UK before 9pm is an indirect example of encouraging better diet. So too the campaign by UK footballer Marcus Rashford to promote healthier school lunches. At the same time, while many dental problems such as caries and periodontal (gum) disease are common preventable diseases, no amount of prevention can make them go away entirely. There will always be a need for accessible dental check-ups and treatments to facilitate good oral health. And it remains important to expand access to such treatments among disadvantaged groups as well as in many low- and middle-income countries so as to reduce inequalities in healthcare provision. Less trips to the dentist would also mean less travel and water consumption Dental procedures require a lot of water, which can be reduced by practicing good oral healthcare. Oral healthcare has higher levels of patient and staff transport than other medical specializations and this is partly due to the need for regular oral health maintenance, whereas other specializations tend only to treat illness. In the UK for instance, staff and patient commuting and travel accounts for approximately two thirds of all emissions from the oral healthcare sector and about eight per cent of the total UK NHS air pollution attributable to travel. This can be reduced significantly, through the maintenance of good oral health, that requires fewer interventions and consequently fewer trips to the dentist. Simple transport habit changes can have a great impact. For example, in October 2021 the Sustainability Committee at Harvard School of Dental Medicine (HSDM) implemented a `Step Challenge´ that encouraged staff, students and faculty to walk, or take public transport rather than drive during that month. They amassed over one million steps in total, preventing the release of approximately 0.28 metric tons of CO2. The practice of dentistry and personal oral healthcare is a significant consumer of water. As a conservative estimate, a bathroom tap delivers about four litres/minute. If we estimate that half the world population cleans their teeth once a day and runs the tap for one minute, the daily global water usage equates to 6,400 Olympic swimming pools. This figure is in addition to undocumented water consumption up and down the oral healthcare manufacturing and distribution supply chain. Reducing dental use of single use plastics and packaging Measures to reduce carbon footprint in dental offices. So what measures can be taken at the dentist office to reduce the carbon footprint of dentistry procedures that are nonetheless essential to good oral health? The use and consequent disposal of single use plastics for many procedures is one of the biggest contributors to the environmental footprint of healthcare generally – and that holds true for dentistry as well. Among single-use plastics, in fact it is the packaging in which the needles, gloves and other oral healthcare products are encased that is the single largest contributor to such waste in the dental industry, with over 90 % ending its life cycle in an incinerator or a landfill. A more thoughtful approach to the design of such packaging – from the plastics content, manufacture and transport, to the potential for reuse, recycling or biodegradability, is therefore one obvious starting point in reducing the carbon footprint of the typical dentist’s office. This is particularly important because packaging, as such, is not “contaminated” biomedical waste that needs special treatment, post-procedure. This requires greater engagement with consumers and waste management companies to segregate, collect and recycle uncontaminated clinical single use plastics (SUPs) as a valuable commodity. It also involves the design and development of more plastic items made from mono-polymer plastics that can be readily recycled. The Flexible Plastics Consortium which represents 34 European companies looking for better plastics content and design solutions for packaging is a good example of how this might work in practice. The United Kingdom’s Plastics Pact is another good example: it has set targets with the goal of 100% of plastic packaging to be reused, recycled or compostable by 2025. Major challenges in managing single use plastic waste from oral healthcare Many single use dental items end up in the waste bin, including gloves, aprons, masks. Once the box is opened, many of the everyday products used in dentistry are only briefly used and then end up in the waste bin. These single-use plastic (SUP) items range from personal protective equipment (aprons, gloves and masks) and other disposable sundries (the mouth-rinse cup or the dental suction tube). SUP biomedical waste requires more specialized management – since these are contaminated with blood and other bodily fluids from oral health procedures. The high safety and quality requirements for these products to be legally compliant, is often incompatible with recycling and materials recovery. The complex nature of items assembled from different plastics also makes recycling difficult, as does the prevailing view that plastic is simply waste and is not considered a valuable resource. Still there are many attempts at finding solutions around the world. These include incentivization schemes and professional education courses that can help manufacturers to design products that can be safely treated and reprocessed, as well as sensitizing dental practitioners to different waste streams, and the treatment they require. Initiatives like the development of a competency-based dental waste management course being undertaken at the Copperbelt University in Zambia are a step in the right direction. Even so, the lack of good technological solutions for the appropriate collection, disinfection/sterilization and subsequent recovery or reprocessing of single use plastics used in biomedical procedures remains an ongoing barrier. We need product research to come up with safe, sustainable solutions for a circular economy, including in the healthcare sector, and governments to adopt supportive policies. Assessing the environmental impacts of oral healthcare as a first step It is important to understand the environmental impacts of materials used in healthcare. A better understanding of the environmental impacts of products and materials used in healthcare systems, from procurement to disposal, is key to any of these measures. Solutions proposed have included more life cycle analysis for all materials used in the healthcare supply chain and the development of a credible ‘sustainability index’ to inform medical supply purchasers about the sustainability credentials of a product. The index could potentially include information on environmental sourcing, ethical manufacturing, supply chain distribution and procurement. This World Oral Health Day we can celebrate the fact that the oral health sector has recognised that it has a vital role to play in healthcare-related climate change mitigation. That is the first step. The next ones will be more challenging and will need ‘teeth’. The FDI World Dental Federation´s Code of Good Practice, which is to be launched later this year, following an extensive consultation with the sector, will be a good starting point for ensuring healthy mouths also help to produce a healthier planet. Steven Mulligan Nicolas Martin Ihsane Ben Yahya Ihsane Ben Yahya is the President of the FDI World Dental Federation and professor at the Dental University in Casablanca, Morocco. Nicolas Martin is the Chair of the FDI Sustainability in Dentistry Task Team. He is also Clinical Professor in Restorative Dentistry in the School of Clinical Dentistry, at the University of Sheffield, UK. Steven Mulligan is a Member of the FDI Sustainability in Dentistry Task Team. He is also a Clinical Lecturer in Restorative Dentistry in the School of Clinical Dentistry, at the University of Sheffield, UK. Image Credits: Mass Communication Specialist Seaman Apprentice Brian H. Abel/Flickr, FDI World Dental Federation , Jan Fidler/Flickr, World Dental Federation , Mass Communication Specialist 3rd Class Everett Allen/Flickr. From COVID to Humanitarian Crises – Medical Oxygen Needs More Prioritization for its Lifesaving Capacities 17/03/2022 Raisa Santos Lifesaving oxygen flows into the lungs of a COVID patient in Chernivtsi, southwest Ukraine before the start of the recent Russian invasion. Whether its due to COVID or conflict, oxygen supplies fall short in many parts of the world. From patients lying in the parking lots of hospitals, in the back seats of cars suffocating as their family members searched frantically for oxygen in India during its second wave of COVID last year, to the inability to receive emergency care amidst constant bombing and shelling in current war-torn Ukraine, global health experts and leaders are desperately searching for ways of improving the global oxygen supply. At a media briefing on the issue Thursday, speakers emphasized the need for both access to oxygen on the ground and more funding to the WHO co-sponsored Access to COVID-19 Tools Accelerator (ACT-A), which is attempting to beef up oxygen supplies in low and middle-income countries. “Oxygen has been treated for too long like a commodity, treated as something that must be delivered,” said WHO Executive Director of Health Emergencies Programme Dr Mike Ryan, speaking at the briefing, cosponsored by the Act Acccelerator and Unitaid. But “oxygen is a capability, not a commodity,” he stressed. Rethinking oxygen’s lifesaving capacities Mike Ryan, Executive Director, Health Emergencies Programme; World Health Organization Ryan and others made the case for rethinking oxygen as a health tool that requires not only a sustainable supply at a country level, but an entire ecosystem of supply and maintenance technology and infrastructure. Its role – and the chronic lack of capacity in many countries – has been underscored by COVID – and again in the very different setting of the Ukraine crisis – where the lack of access for people ranging from COVID patients to mothers in birth and children with pneumonia has prompted widespread alarm. Oxygen remains a critical component of the global COVID-19 response – 75% of patients hospitalized for COVID-19 can be treated with oxygen alone – without any further advanced care. Yet the current global supply of oxygen does not meet needs for both COVID-19 and other serious illnesses. “COVID didn’t cause [the oxygen shortage], COVID uncovered this. COVID laid bare, tore away the bandages from some very old wounds,” said Ryan. UNITAID Commits $56 million to boost access to global medical oxygen supply Robert Matiru, Chair, ACT-A Oxygen Emergency Taskforce & Director Programmes, Unitaid The ACT-A Strategic Plan and Budget for 2022 has identified a funding deficit of $1 billion for oxygen supplies worldwide for this year alone. As a first step to closing that gap, Unitaid has announced that it will invest $56 million to increase access to medical oxygen both for short-term needs related to COVID-19 as well as for the longer term – as a critical foundation for fighting future pandemics. The Unitaid pledge builds on the $50 million USAID has committed in funding for oxygen as pledged at US President Joe Biden’s Global COVID-19 Summit in September 2021. Four Unitaid-funded projects, designed to address global inequities in oxygen access, will be implemented by The Alliance for International Medical Action (ALIMA), the Clinton Health Access Initiative (CHAI), Partners in Health (PIH), and the WHO Health Emergencies Programme. These will also support the work of the ACT-A Oxygen Emergency Task Force by ensuring access to more affordable oxygen solutions such as bulk liquid oxygen, oxygen generation systems, and other important oxygen equipment. Unitaid called on donors, including governments, foundations, and private sector partners to join in the efforts. “Our call here is not just for the present, for this pandemic, but to recognize that donors and funders that come forward and step forward, over and above the generous contributors to date, will help drive a more sustainable ecosystem and [deliver] essential medicines to countries that are lacking it,” said Robert Matiru, Chair of the ACT-A Oxygen Emergency Taskforce and Director of Programmes at Unitaid. Children with pneumonia unrecognized victims – 40% of hospitals in some African countries lack oxygen Numerous countries are facing oxygen shortages, while readily available oxygen products are in short supply. Children are among the unrecognized victims of the lack of oxygen supplies – with childhood pneumonia still one of the biggest killers of under-fives. Accounting for almost a million deaths a year, the highest burden is in sub-Saharan African and South-East Asian countries where children face a double whammy of disease from both the lack of preventive treatments, like vaccinations, along with exposure to heavy indoor air pollution from the open burning of coal, biomass and other such fuels. But an estimated 20 to 40% of these deaths are preventable with increased availability of oxygen therapy. The shortage is particularly acute in low-income sub-Saharan African countries such as Tanzania, Sierra Leone, Liberia, and Gambia, where 40% of health facilities had no access to oxygen and other basic life saving supplies, said Atul Gawande of the United States Agency for International Development (USAID). COVID has led to big surges in needs Daily medical oxygen need for COVID-19 as of 16 March 2022 Along with the chronic shortages, COVID led to a major surge in oxygen needs. Low and middle-income countries (LMICs) need at least 23 million cubic meters of oxygen every day, just to treat COVID patients alone, according to the PATH COVID-19 Oxygen Needs Tracker. On the brighter side, the pandemic has brought a long-ignored aspect of health capacity in LMICs more to the forefront. USAID is currently working in 11 countries to build ‘oxygen ecosystems’ to support oxygen therapy for pneumonia patients, COVID patients, and others, Gawande said. Countries like Ghana now have oxygen generating capacity that can support up to 300,000 patients per day, per year. Gawande noted that the oxygen ecosystem includes liquid oxygen cylinders and concentrators, as well as the clinical engineering and technical assistance to use the technology. But expanding this initiative to other countries still needs more funding. Atul Gawande, USAID “As the Omicron variant abates, I think we’re all starting to feel that we can catch our breath. Oxygen demand may be lower right now. But it is the time that we have to make these investments to enable this kind of [sustainable] capacity.” Gawande said. Oxygen ‘natural security’ and ‘high-return’ health investment Leith Greenslade, Founder/CEO, JustActions & Coordinator, Every Breath Counts Coalition While the recent funding commitments are a positive sign, ‘it is not enough to fund protection’, said Leith Greenslade of the Every Breath Counts Coalition. “It took a pandemic of respiratory infection to wake up the world,” she pointed out. In the past year, about $700 million was invested into the ACT-A Oxygen Emergency Task Force, which has worked in LMICs to prevent oxygen shortages – jump-starting a more focused response. But so far, only a handful of governments – including the United States, Germany, Canada, and France – have borne the funding burden. “But most of the G-20 nations have not stepped up to invest in oxygen,” she charged. Greenslade appealed to donors to see oxygen as a high priority for three reasons: the moral obligation to flatten the COVID-19 curve; oxygen as a “national security” issue in moments of crisis; and finally, oxygen as a high-return health investment that will keep on saving lives beyond the pandemic. “When hospitals run out of oxygen, we have seen strikes and civil unrest in quite a few low- and middle-income countries,” she pointed out. “How many more deaths before this is over will largely depend on access to oxygen and critical care in the countries where the disease is greatest and the health systems are weakest,” she declared. Image Credits: Mstyslav Chernov/ Wikimedia Commons, UNICEF/Ralaivita, PATH, Every Breath Counts . Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates 17/03/2022 Elaine Ruth Fletcher Pfizer’s Paxlovid, an oral antiviral approved by the US FDA in December, has shown 90% efficacy in preventing mortality among those who take it in the first few days of infection. A Medicines Patent Pool (MPP) announcement Thursday that it has signed agreements with 35 companies to manufacture generic versions of Pfizer’s life-saving COVID-19 Paxlovid treatment for distribution in 95 low- and middle-income countries came fire almost immediately from medicines access groups as too little, too late. The MPP-brokered sublicences follow on from an agreement between MPP and Pfizer in November 2021 to supply generic versions of Pfizer patented main drug ingredient, nirmatrelvir, at cost, to countries that represent about 53% of the world’s population. However, activists quickly slammed with the new accord – saying that it would take up many months to actually set up the generic production lines of the game-changing oral drug, which in clinical trials, reduced COVID mortality by 90% among high risk groups. Mapping of the MPP-brokered licenses awarded for manufacture of a generic version of Paxlovid In a joint letter to Pfizer CEO Albert Bourla, delivered Wednesday, a consortium of 100 activist groups, including Amnesty International and Oxfam, said that Pfizer should immediately dedicate two-thirds of the company’s available patented drug supply to low- and middle-income countries, “where there is a proportionate need.” “At present, Pfizer has preferentially sold all of its Paxlovid doses from the first half of 2022 to a handful of high-income countries, and has tentatively promised to supply only 10 million courses of treatment of LMICs,” stated the Health Global Access Project (Health Gap), one of the signatories to Wednesday’s letter, in a follow-up blog posted online just after the MPP announcement. The activists also have slammed the still high price of the new drug in upper-middle and high income countries, saying that this also creates barriers to access. The United States is paying about $530 a day for a five-day course, although Pfizer has committed to a 3-tiered pricing system with lower costs to less affluent countries. “This announcement will do nothing to eliminate the monopoly Pfizer maintains over unlicensed countries – all high-income and almost all upper-middle income countries, representing 47% of the world’s population and historically experiencing the highest rates of COVID-19 infection,” added Brook Baker, Health Gap Senior Policy Analyst and a Professor at Northeastern University School of Law. MSF – A ‘positive step’ forward Médecins Sans Frontières sounded a more positive note, however, saying that the Pfizer agreement with 35 generics manufacturers in 12 countries represents a “positive step toward addressing the ongoing access challenges for this COVID treatment. However, the limitations of the deal remain concerning.” “The limited global supply from the US corporation Pfizer has so far largely been bought up by a number of high-income countries. It is estimated that generic manufacturers will not be able to bring supply to the market until 2023,” stated MSF. Replying to the criticism, an MPP spokesperson stressed that the new agreement “includes all low and lower-middle-income countries as well as some upper-middle income countries in Sub-Saharan Africa that have transitioned to upper-middle-income status in the past five years. The 53% of the world’s population covered by the licenses, “which is equivalent to about 4.1 billion people. As with all our licences we will continue to explore opportunities to broaden geographic scope, where possible,” the MPP spokesperson added. Design of MPP agreement According to MPP, the non-exclusive sublicence deals will allow generic manufacturers to produce the raw ingredients for Paxlovid’s main active ingredient, nirmatrelvir, and/or the finished drug itself, which is co-packaged with a common HIV drug, ritonavir. It said that six companies will focus on producing the drug substance, nine companies will produce the finished drug product and the remainder will do both. The manufacturers are based in 12 countries including: Bangladesh, Brazil, China, Dominican Republic, Jordan, India, Israel, Mexico, Pakistan, Serbia, Republic of Korea, and Vietnam. “A licence has also been offered to a company in Ukraine, the offer will remain available to them as they are not able to sign due to the current conflict,” MPP said. The deal signed between MPP and Pfizer in November 2021 established the terms and conditions, for the generic licenses, MPP added. Following that, “The requests for sublicences from generic producers were reviewed by MPP and presented to Pfizer,” for its approval – one of the conditions of the sale. Pfizer will not receive royalties from sales of nirmatrelvir from the MPP-negotiated sublicensees for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization, MPP added. Following the pandemic period, sales to low-income countries will remain royalty free, lower-middle-income countries and upper-middle-income countries will be subject to a 5% royalty for sales to the public sector and a 10% royalty for sales to the private sector. “Nirmatrelvir is a new product and requires substantial manufacturing capabilities to produce, and we have been very impressed with the quality of manufacturing demonstrated by these companies,” said Charles Gore, MPP Executive Director. “Furthermore, 15 companies are signing their first licence with MPP, and we warmly welcome our new generic manufacturing partners.” “We have established a comprehensive strategy in partnership with worldwide governments, international global health leaders and global manufacturers to help ensure access to our oral COVID-19 treatment for patients in need around the world, said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “The MPP sublicensees and the additional capacity for COVID-19 treatment they will supply will play a critical role to help ensure that people everywhere, particularly those living in the poorest parts of the world, have equitable access to an oral treatment option against COVID-19.” Image Credits: Pfizer , Medicines Patent Pool . Fourth COVID Vaccine Jab Provides Little Extra Protection to Healthy Individuals – NEJM 16/03/2022 Maayan Hoffman A month after a fourth dose of the Pfizer or Moderna vaccines was administered to hundreds of people in an Israeli clinical trial, authors of the new study on the extra booster say it provides “little protection, if any, from infection by COVID-19 among vaccinated young and healthy individuals in comparison to those vaccinated with only a third dose.” Result of the open-label study, conducted at Israel’s Sheba Medical Center, were published Wednesday evening in the New England Journal of Medicine as a correspondence. The findings contradict statements made by Pfizer CEO Albert Bourla over the weekend that a fourth booster dose could necessary for most people, due to waning immunity. Bourla made the statement as Pfizer seeks quick US Food and Drug Administration approval of a fourth dose, effectively a second booster, for people 65 and older. The new Sheba study included approximately 600 volunteers, among them 270 who received a fourth shot of either the Moderna or Pfizer vaccine. All of the volunteers had received three shots of the Pfizer vaccine prior to the trial. Sheba’s Professor Gili Regev-Yochay, lead author of the study, said in a statement that COVID infection rates among four-time vaccinated individuals were only slightly lower than those in the control group. However, she added that the fourth jab did provide moderate protection against symptomatic infection among young and healthy individuals, in comparison to those who had only received three jabs. “We found no differences, both in terms of IgG antibody levels and in terms of neutralizing antibody levels,” added Regev-Yochay, referring to the impact of the fourth jab on the study group in comparison to the control. “It should be emphasized that the third dose is extremely important for anyone who has not yet contracted COVID-19,” Regev-Yochay stressed, “and the fourth dose is most likely important for populations with risk factors, for which a fourth vaccine would protect from serious illness.” The NEJM correspondence, however, said that the fourth dose was “immunogenic, safe and somewhat efficacious”, adding that “our results suggest that maximal immunogenicity of mRNA vaccines is achieved after three doses and that antibody levels can be restored by a fourth dose.” The researchers added that they observed “low vaccine efficacy against infections in health care workers, as well as relatively high viral loads suggesting that those who were infected were infectious.” Bourla: Fourth shot ‘necessary’ The release of the data comes at an awkward time for Pfizer, after a weekend when Bourla said in an interview with CBS’s Face the Nation that a fourth COVID-19 shot would be “necessary” for most people to prevent future infection. Pfizer CEO Albert Bourla in a CBS interview on March 13, 2022. “Right now, the way that we have seen, it is necessary, a fourth booster right now,” Bourla said in the interview. “The protection that you are getting from the third, it is good enough, actually quite good for hospitalizations and deaths. It’s not that good against infections, but doesn’t last very long.” While Bourla said Pfizer had submitted data on the efficacy of the fourth shot to the US FDA, the data has not yet been publicly released. 1. A fourth dose of the Covid-19 vaccine is necessary for most people due to waning immunity, said Pfizer CEO Albert Bourla. He noted that the regimen of two doses plus a booster is not able to offer sufficient protection against new variants. pic.twitter.com/XPCFwiqluD — BFM News (@NewsBFM) March 14, 2022 The US Centers for Disease Control and Prevention currently recommends three jabs for everyone age 12 years and up, and two shots for children between the ages of five and 11. Individuals who are immunocompromised are encouraged to get an extra dose. Fourth dose still protects against severe infection, separate study found A separate Israeli study published, on February 1 by the Israeli Health Ministry, offered somewhat contradictory results to the Sheba findings – although the Ministry of Health study focused only on older people. That study, released on the pre-print biomedical website MedRXiv, found that rates of confirmed COVID-19 infection, as well as severe illness, were lower following a fourth dose, when compared to only three doses. Specifically, the team looked at data from 1,138,681 persons aged over 60 years and eligible for the fourth dose between January 15 and 27, 2022 – the height of the Omicron wave in Israel. They compared the rate of confirmed COVID infections and severe COVID illness between those who took a fourth jab at least 12 days earlier and those who only had three doses, or alternatively those who became ill less than a week after receiving the fourth dose. “The rate of confirmed infection was lower in people 12 or more days after their fourth dose than among those who received only three doses and those 3 to 7 days after vaccination by factors of 2.0 and 1.9, respectively. The rate of severe illness was lower by factors of 4.3 and 4.0,” the authors wrote. ‘Vaccines don’t prevent infection’ Professor Cyrille Cohen, head of the immunology lab at Bar-Ilan University, said that the findings from the Sheba study are not surprising; “the vaccines are not good enough to prevent infection, and even more so with the Omicron variant,” he said. However, like Regev-Yochay, Cohen stressed that there is a growing body of data that shows there remains a substantial difference in the levels of protection acquired by people who are vaccinated with two doses and those who get three doses, when it comes to developing severe disease. “Look at the ratio between people age 60 who got three doses and people that were not vaccinated and got two doses. Even with Omicron, the third dose can reduce the chance of developing severe disease by a factor of four or five and for people above 60 that number becomes 10 to 20,” Cohen said. He also noted that a fourth dose also may help the most vulnerable, noting that today, the serious cases in Israel still tend to be older people with comorbidities or unvaccinated people. “Based on that, a fourth dose for selected populations might demonstrate a benefit,” he said. When asked about Bourla’s statement, Cohen said “it was not clear” and that perhaps the Pfizer CEO was referring to people receiving a shot of the Omicron-adapted vaccine, for which data has not yet been released. A multi-country clinical trial of that vaccine is now underway, including a trial arm in Israel. “I am personally extremely curious to see those results,” Cohen said. Image Credits: Screenshot. Attacks on Health Facilities Are Becoming ‘Part of War Strategy’ in Conflict Zones, Warns WHO 16/03/2022 Kerry Cullinan Attacks on health facilities appear to be part of a deliberate war strategy in Ukraine and other recent conflicts, according to the head of the World Health Organization (WHO) health emergencies programme. The WHO has verified 43 attacks on Ukrainian health facilities since Russia’s invasion on 24 February – and it expects further attacks as over 300 health facilities in conflict areas or under Russian control and a further 600 facilities within 10 kilometres of conflict. But WHO Director-General Dr Tedros Adhanom Ghebreyesus told a media briefing on Wednesday that there had also been 46 attacks on health facilities worldwide since the start of 2022, and people caught in conflicts in Tigray, Yemen and Syria were in extreme need of humanitarian assistance. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme, said that in these conflict zones, attacks on health facilities appeared to be deliberate – in complete violation of international law. “We have never seen this rate of attacks on health care, and health care becoming a target in these situations. It’s becoming part of the strategy and tactics of war and it is entirely unacceptable,” said Ryan. “Under international humanitarian law. conflicting parties are actually instructed to specifically take measures to avoid attacking or inadvertently destroying or hurting health workers or health facilities. They don’t bear responsibility not just to not attack. They actually bear responsibility to ensure that they don’t attack to identify those facilities, to deconflict those facilities and to ensure that they do not, as part of their prosecution of war, attack those facilities,” he added. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme. Multiple conflicts out of the global eye “Although Ukraine is the focus of the world’s attention, it’s far from the only crisis to which WHO is responding,” said Tedros. “In Yemen, roughly two-thirds of the population – more than 20 million people – are estimated to be in need of health assistance. In Afghanistan, more than half the population is in need, with widespread malnutrition and a surge in measles among many other challenges. “And in Ethiopia, six million people in Tigray have been under blockade by Ethiopian and Eritrean forces for almost 500 days, sealed off from the outside world. There is almost no fuel, no cash and no communications. No food aid has been delivered since the middle of December and 83% of the population is food insecure,” said Tedros, who is from Tigray and added his family and friends were affected by the blockade. Aid to Ukraine – but little for Tigray WHO Director-General Dr Tedros Adhanom Ghebreyesus. The WHO has been able to deliver about 100 metric tonnes of supplies to Ukraine, including oxygen, insulin, surgical supplies, anaesthetics and blood transfusion kits; oxygen generators, electrical generators and defibrillators. However, it had only received $8million of the $57.5 million it needed to support Ukraine. In contrast, however, it had only been able to airlift 33 metric tonnes of medicines and other supplies to Tigray in December – enough for 300,000 people – after being denied access to the territory since last July. “We estimate that 2,200 metric tonnes of emergency health supplies are needed to respond to urgent health needs in Tigray,” said Tedros. Treatment for 46,000 Tigrayan people living with HIV has been abandoned, as has treatment for people with cancer, diabetes, hypertension and tuberculosis. “The situation in Tigray is catastrophic. The blockade on communications, including on journalists being able to report from Tigray, means it remains a forgotten crisis. Out of sight and out of mind,” added Tedros. “Just as we continue to call on Russia to make peace in Ukraine, so we continue to call on Ethiopia and Eritrea to end the blockade, the siege, and allow safe access for humanitarian supplies and workers to save lives,” said Tedros. Global COVID-19 cases rise again Meanwhile, after weeks of global decline COVID-19 cases are on the rise again, especially in parts of Asia. “In the last week, we saw an 8% increase in cases detected with more than 11 million cases reported to WHO despite a significant reduction in testing that’s occurring worldwide,” said WHO COVID-19 lead Dr Maria van Kerkhove. She ascribed the increase to the spread of the Omicron variant – particularly the BA.2 lineage which is “the most transmissible variant we have seen of the SARS Co-V2 virus to date” – in a context where restrictions were being lifted globally. Ryan added that the virus would move from one “pocket of susceptibility” where immunity was waning to another. “The likelihood is that this virus will echo around the world,” said Ryan. “It will pick up pockets of susceptibility and will survive in those pockets for months and months until another pocket of susceptibility opens up,” said Ryan. “This is how viruses work. They establish themselves within a community and they will move quickly to the next community that’s unprotected. If communities around the virus are well protected, the virus can sustain itself, even in small communities. It can stay there, it can rest there, and then wait until susceptibility grows.” Image Credits: Markus Spiske/ Unsplash. WTO Head Welcomes Compromise on IP Waiver for COVID Vaccines – But Activists and Pharma Express Dismay 16/03/2022 Kerry Cullinan WTO members last week in session at the TRIPS Council, which has been debating a controversial proposal for an IP waiver on COVID products for over a year. The World Trade Organization’s (WTO) Director-Genera, Dr Ngozi Okonjo-Iweala has “warmly welcomed” the breakthrough reached this week over a waiver on intellectual property for the production of COVID-19 vaccines. “This is a major step forward and this compromise is the result of many long and difficult hours of negotiations. But we are not there yet. We have more work to do to ensure that we have the support of the entire WTO Membership,” said Okonjo-Iweala, in a statement on Wednesday. The agreement reached between the European Union, India, South Africa and the United States – referred to in some quarters as “the Quad” – still needs to be put to all 164 WTO members, which typically decides by consensus. However, the compromise now has good chances of being approved since EU countries had been the major opponents to the proposal by South Africa and India, submitted in October 2020, to waive IP on COVID-19 vaccines and other pandemic-related health products for the duration of the pandemic. Major concessions South Africa and India had to make major conceessions – both narrowing the waiver to only vaccines, as well as narrowing the list of countries that would be eligible to take advantage of the waiver on patents and other IP. “My team and I have been working hard for the past three months and we are ready to roll up our sleeves again to work together with the TRIPS Council Chair Ambassador Lansana Gberie (Sierra Leone) to bring about a full agreement as quickly as possible. We are grateful to the four Members for the difficult work they have undertaken so far,” said Okonjo-Iweala. The WTO’s Ministerial Council (MC12), postponed from late November to the week of June 13, could potentially approve the waiver move – although the date of that meeting has also been cast into doubt due to the recent outbreak of war in the Ukraine. However, the draft text of the proposed compromise, published by STAT News Tuesday evening, has elicited dismay from both health activists and the pharmaceutical industry – for not going far enough, or for going too far. Restricted to vaccines and certain developing countries In essence, the compromise does three things: Most critically, the new waiver would allow developing countries to not only manufacture, but also to export, generic versions of COVID vaccines that are still under patent protection. Currently, Article 31.f of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement restricts such generic manufacture to health products that are “predominantly for the supply of the domestic market” – leaving low-income countries with no manufacturing base unable to import cheaper generic versions of products from abroad. However, the waiver would be limited to countries that exported less than 10% of the world’s vaccines in 2021. That effectively excludes well-established manufacturers in China, but not India, from waiver eligibility. In contrast to the original Indian-South African proposal, the new IP flexibilities are restricted to COVID vaccines, thus excluding COVID treatments such as new antivirals that are particularly important for countries with low vaccination rates, as well as tests, personal protective equipment (PPE) and other pandemic-related goods. Adam Hodge, spokesperson for US Trade Representative Ambassador Katherine Tai, said late Tuesday that the “compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome” after a “difficult and protracted process”. Since last May @USTradeRep has worked hard to facilitate an outcome on IP that can achieve consensus across the 164 @WTO Members to help end the pandemic. USTR joined informal discussions led by the WTO Secretariat with South Africa, India, and the EU to try & break the deadlock. — USTR Office of Public Affairs (@USTRSpox) March 15, 2022 He and others cautioned that details of a final text were yet to be concluded. “While no agreement on text has been reached and we are in the process of consulting on the outcome, the US will continue to engage with WTO Members as part of our comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible,” added Hodge. The informal discussions, led by the WTO Secretariat, have been trying to break the deadlock between the India-South Africa waiver proposal (supported by the Africa and Least Developed Nations groups and others) and the EU’s counter-proposal. India-South Africa proposal had sought a broad waiver on all vaccines, tests and treatments, while the EU had pushed for technical modifications in the existing TRIPS rules. Medicines access activists and pharma leaders both express dismay Both activists and industry reacted with dismay to news of the proposed agreement. For example, the US-based consumer advocacy group, Public Citizen, called on WTO member states to reject the proposal. “Among its key limitations: the proposal appears to cover only vaccines (not tests and treatments), cover only patents (not other important intellectual property barriers), be limited geographically, and further undermine current WTO flexibilities for compulsory licenses,” according to Melinda St Louis, director of Public Citizen’s Global Trade Watch division. “It would be a mistake for WTO members to prematurely agree to a weakened waiver that provides political cover to the US and EU while not making any meaningful difference in increasing access to vaccines, tests and treatments. No waiver is better than a weak waiver designed solely to save face,” added St Louis. Knowledge Ecology International also expressed disquiet, saying that the waiver may even restrict certain flexibilities that are already allowed by Article 31 of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), regarding a country’s rights to manufacture and export generic versions of drugs or vaccines during a health emergency. “Countries are required to follow Article 31 of the TRIPS [agreement], which of course, is an existing and not a new flexibility, but with ‘clarifications’,” noted KEI’s Director, James Love. However, those “clarifications”, also come with new obligations that could make Article 31 “more restrictive and burdensome”, such as a new obligation for a country to identify all of the patents to which it is applying an IP waiver, and to notify the WTO of its use of the waiver – something not required for the issuance of compulsory licenses in general. On the other hand, the draft agreement makes a first-ever reference to a 2005 WHO/UNDP guidance on payments by developing countries to the original patent-holder, which embraces the concept of “tiered royalties”, based on a country’s ability to pay, and authored by Love himself. Pharma says agreement sends ‘wrong signal’ Meanwhile, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said that “weakening patents now when it is widely acknowledged that there are no longer supply constraints of COVID-19 vaccines, sends the wrong signal”. “When the IP TRIPS Waiver was first proposed in 2020, it was to the wrong solution to the problem of scaling up manufacturing of potential COVID-19 vaccines which at the time had not yet even been authorized,” said the IFPMA. “Now the problem of supply has been addressed thanks to unprecedented collaboration involving companies from industrialized and developing countries, the TRIPS Waiver is not only the wrong solution, it is also an outdated proposal, that has been overtaken by events.” It added that the TRIPS waiver proposal is “political posturing that are at best a distraction, at worse creating uncertainty that can undermine innovation’s ability to respond to the current and future response to pandemics”. “The current proposals should be shelved; and the focus should be directed, to admittedly more difficult actions that will change lives for the better: supporting country readiness, contributing to equitable distribution, and driving innovation,” the IFPMA concluded. The final text of any agreement would first need to be approved by the WTO TRIPS Council, and then go before the MC12 for final approval. The TRIPS Council last met on 9-10 March, but at the time failed to reach a compromise – although some sources noted that the were close to agreement as the “Quad” of India, South Africa, the United States and the EU scrambled to reach a deal. According to a WTO statement on 10 March, the TRIPS Council had agreed to keep the agenda item on the IP waiver open – so as to enable the council to be “reconvened at short notice if substantial progress is made in the high-level talks”. TRIPS Council approval would pave the way for a consensus agreement at the WTO’s Ministerial meeting, MC12. Russian Soldiers Hold Health Workers and Patients Hostage at Mariupol Hospital, says Human Rights Group 15/03/2022 Kerry Cullinan Mariupol Regional Hospital before it was bombed Health workers, patients and civilians have been held hostage at the Mariupol regional intensive care hospital in Ukraine by Russian troops since Monday morning, according to the Media Initiative for Human Rights (MIHR). Russian soldiers are using the hospital as a base to attack Ukrainian forces, and using the hostages as “human shields” according to MIHR, a respected human rights monitoring group in Ukraine. “We received information from a doctor from the hospital. We can’t name him because of the threat to him. More information will be available after the person is safe,” the MIHR reported on its Facebook page. Pavlo Kyrylenko, head of the Donetsk regional administration, also reported the hostage situation on his Telegram account. Kyrylenko reported that a hostage had told him: “It is impossible to leave the hospital. There is heavy shelling. We sit in the basement. Cars have not been able to drive into the hospital for two days. High-rise buildings are burning around… Russians rushed 400 people from neighbouring houses to our hospital. We can’t leave. “ While the 550-bed tertiary hospital, the biggest in the Donetsk region, has suffered extensive damage, health workers have continued to attend to patients from the basement. “I appeal to international human rights organizations to respond to these vicious violations of the norms and customs of war, to these egregious crimes against humanity,” said Kyrylenko. Humanitarian groups have been appealing for days for a safe passage corridor to and from Mariupol. Some private cars were finally able to leave the city on Monday and Tuesday, the first time in 10 days. But Russian troops that have beseiged the city on all sides have not allowed relief workers to bring in desperately needed medical supplies, food or water. Mariupol. Direct strike of Russian troops at the maternity hospital. People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror? Close the sky right now! Stop the killings! You have power but you seem to be losing humanity. pic.twitter.com/FoaNdbKH5k — Volodymyr Zelenskyy / Володимир Зеленський (@ZelenskyyUa) March 9, 2022 Last week, Russian troops bombed the Mariupol maternity hospital, reportedly killing at least three people. A pregnant woman evacuated from the hospital and her baby later died from their injuries. Mariupol’s deputy mayor, Sergey Orlov, told France24 on Tuesday that at least 2,358 people had been killed during the 11-day siege of the south-eastern city, and he had been fielding desperate calls from people trapped in basements without food or water. While small numbers of people escaped the besieged city on Monday after a series of failed evacuation attempts, as many as 2,500 civilians have died in Mariupol, Ukrainian officials estimate https://t.co/1ksWTFnzaf — CNN International (@cnni) March 15, 2022 ‘Act of unconscionable cruelty’ The World Health Organization (WHO) has verified 31 attacks on health facilities between the start of the Russian invasion on 24 February and 11 March, resulting in 12 deaths and 34 injuries, of which 8 of the injured and 2 of those killed were health workers. My hometown Volnovakha. I was born at this hospital. Now it’s officially denazified and liberated by Russia. pic.twitter.com/nV9lyZX4uQ — Illia Ponomarenko 🇺🇦 (@IAPonomarenko) March 15, 2022 “We call for an immediate cessation of all attacks on health care in Ukraine. These horrific attacks are killing and causing serious injuries to patients and health workers, destroying vital health infrastructure and forcing thousands to forgo accessing health services despite catastrophic needs,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, UNICEF Executive Director Catherine Russell and UNFPA Executive Director Dr Natalia Kanem, in a joint statement on Sunday. “To attack the most vulnerable – babies, children, pregnant women, and those already suffering from illness and disease, and health workers risking their own lives to save lives – is an act of unconscionable cruelty,” they added. “We must be able to safely deliver emergency medical supplies – including those required for obstetric and neonatal care – to health centers, temporary facilities and underground shelters.” Intentionally attacking health facilities is prohibited under international humanitarian law. Unusual position of surrogates Since the start of the war, more than 4,300 Ukrainian women have given birth, and 80,000 others are expected to give birth in the next three months. “Oxygen and medical supplies, including for the management of pregnancy complications, are running dangerously low,” according to the three leaders. “Many pregnant women may need health care, medication and assistance on a daily basis or when complications with pregnancy occur. When medical facilities are not accessible, are destroyed, or health care personnel and medical product are scarce or unavailable, maternal health can be endangered,” according to Eszther Kisomodi and Emma Pitchford, the chief executive and executive editor respectively of the journal, Sexual and Reproductive Health Matters. They also warned that many pregnant women might be in “particular and unusual situations” as Ukraine “is an international surrogacy hub, one of only a handful of countries in the world that legally allows foreigners to enter into surrogacy arrangements”. https://twitter.com/thedalstonyears/status/1501861609446289410 “Being a surrogate is a job in Ukraine for many women, but not one that they can quit, or even put on hold. Very serious questions occur for all parties in this arrangement – for the pregnant women, the newborn child and the intended parents.” The authors also highlight the precarious position of people with disabilities who cannot move easily, LBGTQ people in the face of hostile Russian forces, and people living with HIV in Ukraine, which has the second-highest infection rate in Europe. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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From COVID to Humanitarian Crises – Medical Oxygen Needs More Prioritization for its Lifesaving Capacities 17/03/2022 Raisa Santos Lifesaving oxygen flows into the lungs of a COVID patient in Chernivtsi, southwest Ukraine before the start of the recent Russian invasion. Whether its due to COVID or conflict, oxygen supplies fall short in many parts of the world. From patients lying in the parking lots of hospitals, in the back seats of cars suffocating as their family members searched frantically for oxygen in India during its second wave of COVID last year, to the inability to receive emergency care amidst constant bombing and shelling in current war-torn Ukraine, global health experts and leaders are desperately searching for ways of improving the global oxygen supply. At a media briefing on the issue Thursday, speakers emphasized the need for both access to oxygen on the ground and more funding to the WHO co-sponsored Access to COVID-19 Tools Accelerator (ACT-A), which is attempting to beef up oxygen supplies in low and middle-income countries. “Oxygen has been treated for too long like a commodity, treated as something that must be delivered,” said WHO Executive Director of Health Emergencies Programme Dr Mike Ryan, speaking at the briefing, cosponsored by the Act Acccelerator and Unitaid. But “oxygen is a capability, not a commodity,” he stressed. Rethinking oxygen’s lifesaving capacities Mike Ryan, Executive Director, Health Emergencies Programme; World Health Organization Ryan and others made the case for rethinking oxygen as a health tool that requires not only a sustainable supply at a country level, but an entire ecosystem of supply and maintenance technology and infrastructure. Its role – and the chronic lack of capacity in many countries – has been underscored by COVID – and again in the very different setting of the Ukraine crisis – where the lack of access for people ranging from COVID patients to mothers in birth and children with pneumonia has prompted widespread alarm. Oxygen remains a critical component of the global COVID-19 response – 75% of patients hospitalized for COVID-19 can be treated with oxygen alone – without any further advanced care. Yet the current global supply of oxygen does not meet needs for both COVID-19 and other serious illnesses. “COVID didn’t cause [the oxygen shortage], COVID uncovered this. COVID laid bare, tore away the bandages from some very old wounds,” said Ryan. UNITAID Commits $56 million to boost access to global medical oxygen supply Robert Matiru, Chair, ACT-A Oxygen Emergency Taskforce & Director Programmes, Unitaid The ACT-A Strategic Plan and Budget for 2022 has identified a funding deficit of $1 billion for oxygen supplies worldwide for this year alone. As a first step to closing that gap, Unitaid has announced that it will invest $56 million to increase access to medical oxygen both for short-term needs related to COVID-19 as well as for the longer term – as a critical foundation for fighting future pandemics. The Unitaid pledge builds on the $50 million USAID has committed in funding for oxygen as pledged at US President Joe Biden’s Global COVID-19 Summit in September 2021. Four Unitaid-funded projects, designed to address global inequities in oxygen access, will be implemented by The Alliance for International Medical Action (ALIMA), the Clinton Health Access Initiative (CHAI), Partners in Health (PIH), and the WHO Health Emergencies Programme. These will also support the work of the ACT-A Oxygen Emergency Task Force by ensuring access to more affordable oxygen solutions such as bulk liquid oxygen, oxygen generation systems, and other important oxygen equipment. Unitaid called on donors, including governments, foundations, and private sector partners to join in the efforts. “Our call here is not just for the present, for this pandemic, but to recognize that donors and funders that come forward and step forward, over and above the generous contributors to date, will help drive a more sustainable ecosystem and [deliver] essential medicines to countries that are lacking it,” said Robert Matiru, Chair of the ACT-A Oxygen Emergency Taskforce and Director of Programmes at Unitaid. Children with pneumonia unrecognized victims – 40% of hospitals in some African countries lack oxygen Numerous countries are facing oxygen shortages, while readily available oxygen products are in short supply. Children are among the unrecognized victims of the lack of oxygen supplies – with childhood pneumonia still one of the biggest killers of under-fives. Accounting for almost a million deaths a year, the highest burden is in sub-Saharan African and South-East Asian countries where children face a double whammy of disease from both the lack of preventive treatments, like vaccinations, along with exposure to heavy indoor air pollution from the open burning of coal, biomass and other such fuels. But an estimated 20 to 40% of these deaths are preventable with increased availability of oxygen therapy. The shortage is particularly acute in low-income sub-Saharan African countries such as Tanzania, Sierra Leone, Liberia, and Gambia, where 40% of health facilities had no access to oxygen and other basic life saving supplies, said Atul Gawande of the United States Agency for International Development (USAID). COVID has led to big surges in needs Daily medical oxygen need for COVID-19 as of 16 March 2022 Along with the chronic shortages, COVID led to a major surge in oxygen needs. Low and middle-income countries (LMICs) need at least 23 million cubic meters of oxygen every day, just to treat COVID patients alone, according to the PATH COVID-19 Oxygen Needs Tracker. On the brighter side, the pandemic has brought a long-ignored aspect of health capacity in LMICs more to the forefront. USAID is currently working in 11 countries to build ‘oxygen ecosystems’ to support oxygen therapy for pneumonia patients, COVID patients, and others, Gawande said. Countries like Ghana now have oxygen generating capacity that can support up to 300,000 patients per day, per year. Gawande noted that the oxygen ecosystem includes liquid oxygen cylinders and concentrators, as well as the clinical engineering and technical assistance to use the technology. But expanding this initiative to other countries still needs more funding. Atul Gawande, USAID “As the Omicron variant abates, I think we’re all starting to feel that we can catch our breath. Oxygen demand may be lower right now. But it is the time that we have to make these investments to enable this kind of [sustainable] capacity.” Gawande said. Oxygen ‘natural security’ and ‘high-return’ health investment Leith Greenslade, Founder/CEO, JustActions & Coordinator, Every Breath Counts Coalition While the recent funding commitments are a positive sign, ‘it is not enough to fund protection’, said Leith Greenslade of the Every Breath Counts Coalition. “It took a pandemic of respiratory infection to wake up the world,” she pointed out. In the past year, about $700 million was invested into the ACT-A Oxygen Emergency Task Force, which has worked in LMICs to prevent oxygen shortages – jump-starting a more focused response. But so far, only a handful of governments – including the United States, Germany, Canada, and France – have borne the funding burden. “But most of the G-20 nations have not stepped up to invest in oxygen,” she charged. Greenslade appealed to donors to see oxygen as a high priority for three reasons: the moral obligation to flatten the COVID-19 curve; oxygen as a “national security” issue in moments of crisis; and finally, oxygen as a high-return health investment that will keep on saving lives beyond the pandemic. “When hospitals run out of oxygen, we have seen strikes and civil unrest in quite a few low- and middle-income countries,” she pointed out. “How many more deaths before this is over will largely depend on access to oxygen and critical care in the countries where the disease is greatest and the health systems are weakest,” she declared. Image Credits: Mstyslav Chernov/ Wikimedia Commons, UNICEF/Ralaivita, PATH, Every Breath Counts . Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates 17/03/2022 Elaine Ruth Fletcher Pfizer’s Paxlovid, an oral antiviral approved by the US FDA in December, has shown 90% efficacy in preventing mortality among those who take it in the first few days of infection. A Medicines Patent Pool (MPP) announcement Thursday that it has signed agreements with 35 companies to manufacture generic versions of Pfizer’s life-saving COVID-19 Paxlovid treatment for distribution in 95 low- and middle-income countries came fire almost immediately from medicines access groups as too little, too late. The MPP-brokered sublicences follow on from an agreement between MPP and Pfizer in November 2021 to supply generic versions of Pfizer patented main drug ingredient, nirmatrelvir, at cost, to countries that represent about 53% of the world’s population. However, activists quickly slammed with the new accord – saying that it would take up many months to actually set up the generic production lines of the game-changing oral drug, which in clinical trials, reduced COVID mortality by 90% among high risk groups. Mapping of the MPP-brokered licenses awarded for manufacture of a generic version of Paxlovid In a joint letter to Pfizer CEO Albert Bourla, delivered Wednesday, a consortium of 100 activist groups, including Amnesty International and Oxfam, said that Pfizer should immediately dedicate two-thirds of the company’s available patented drug supply to low- and middle-income countries, “where there is a proportionate need.” “At present, Pfizer has preferentially sold all of its Paxlovid doses from the first half of 2022 to a handful of high-income countries, and has tentatively promised to supply only 10 million courses of treatment of LMICs,” stated the Health Global Access Project (Health Gap), one of the signatories to Wednesday’s letter, in a follow-up blog posted online just after the MPP announcement. The activists also have slammed the still high price of the new drug in upper-middle and high income countries, saying that this also creates barriers to access. The United States is paying about $530 a day for a five-day course, although Pfizer has committed to a 3-tiered pricing system with lower costs to less affluent countries. “This announcement will do nothing to eliminate the monopoly Pfizer maintains over unlicensed countries – all high-income and almost all upper-middle income countries, representing 47% of the world’s population and historically experiencing the highest rates of COVID-19 infection,” added Brook Baker, Health Gap Senior Policy Analyst and a Professor at Northeastern University School of Law. MSF – A ‘positive step’ forward Médecins Sans Frontières sounded a more positive note, however, saying that the Pfizer agreement with 35 generics manufacturers in 12 countries represents a “positive step toward addressing the ongoing access challenges for this COVID treatment. However, the limitations of the deal remain concerning.” “The limited global supply from the US corporation Pfizer has so far largely been bought up by a number of high-income countries. It is estimated that generic manufacturers will not be able to bring supply to the market until 2023,” stated MSF. Replying to the criticism, an MPP spokesperson stressed that the new agreement “includes all low and lower-middle-income countries as well as some upper-middle income countries in Sub-Saharan Africa that have transitioned to upper-middle-income status in the past five years. The 53% of the world’s population covered by the licenses, “which is equivalent to about 4.1 billion people. As with all our licences we will continue to explore opportunities to broaden geographic scope, where possible,” the MPP spokesperson added. Design of MPP agreement According to MPP, the non-exclusive sublicence deals will allow generic manufacturers to produce the raw ingredients for Paxlovid’s main active ingredient, nirmatrelvir, and/or the finished drug itself, which is co-packaged with a common HIV drug, ritonavir. It said that six companies will focus on producing the drug substance, nine companies will produce the finished drug product and the remainder will do both. The manufacturers are based in 12 countries including: Bangladesh, Brazil, China, Dominican Republic, Jordan, India, Israel, Mexico, Pakistan, Serbia, Republic of Korea, and Vietnam. “A licence has also been offered to a company in Ukraine, the offer will remain available to them as they are not able to sign due to the current conflict,” MPP said. The deal signed between MPP and Pfizer in November 2021 established the terms and conditions, for the generic licenses, MPP added. Following that, “The requests for sublicences from generic producers were reviewed by MPP and presented to Pfizer,” for its approval – one of the conditions of the sale. Pfizer will not receive royalties from sales of nirmatrelvir from the MPP-negotiated sublicensees for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization, MPP added. Following the pandemic period, sales to low-income countries will remain royalty free, lower-middle-income countries and upper-middle-income countries will be subject to a 5% royalty for sales to the public sector and a 10% royalty for sales to the private sector. “Nirmatrelvir is a new product and requires substantial manufacturing capabilities to produce, and we have been very impressed with the quality of manufacturing demonstrated by these companies,” said Charles Gore, MPP Executive Director. “Furthermore, 15 companies are signing their first licence with MPP, and we warmly welcome our new generic manufacturing partners.” “We have established a comprehensive strategy in partnership with worldwide governments, international global health leaders and global manufacturers to help ensure access to our oral COVID-19 treatment for patients in need around the world, said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “The MPP sublicensees and the additional capacity for COVID-19 treatment they will supply will play a critical role to help ensure that people everywhere, particularly those living in the poorest parts of the world, have equitable access to an oral treatment option against COVID-19.” Image Credits: Pfizer , Medicines Patent Pool . Fourth COVID Vaccine Jab Provides Little Extra Protection to Healthy Individuals – NEJM 16/03/2022 Maayan Hoffman A month after a fourth dose of the Pfizer or Moderna vaccines was administered to hundreds of people in an Israeli clinical trial, authors of the new study on the extra booster say it provides “little protection, if any, from infection by COVID-19 among vaccinated young and healthy individuals in comparison to those vaccinated with only a third dose.” Result of the open-label study, conducted at Israel’s Sheba Medical Center, were published Wednesday evening in the New England Journal of Medicine as a correspondence. The findings contradict statements made by Pfizer CEO Albert Bourla over the weekend that a fourth booster dose could necessary for most people, due to waning immunity. Bourla made the statement as Pfizer seeks quick US Food and Drug Administration approval of a fourth dose, effectively a second booster, for people 65 and older. The new Sheba study included approximately 600 volunteers, among them 270 who received a fourth shot of either the Moderna or Pfizer vaccine. All of the volunteers had received three shots of the Pfizer vaccine prior to the trial. Sheba’s Professor Gili Regev-Yochay, lead author of the study, said in a statement that COVID infection rates among four-time vaccinated individuals were only slightly lower than those in the control group. However, she added that the fourth jab did provide moderate protection against symptomatic infection among young and healthy individuals, in comparison to those who had only received three jabs. “We found no differences, both in terms of IgG antibody levels and in terms of neutralizing antibody levels,” added Regev-Yochay, referring to the impact of the fourth jab on the study group in comparison to the control. “It should be emphasized that the third dose is extremely important for anyone who has not yet contracted COVID-19,” Regev-Yochay stressed, “and the fourth dose is most likely important for populations with risk factors, for which a fourth vaccine would protect from serious illness.” The NEJM correspondence, however, said that the fourth dose was “immunogenic, safe and somewhat efficacious”, adding that “our results suggest that maximal immunogenicity of mRNA vaccines is achieved after three doses and that antibody levels can be restored by a fourth dose.” The researchers added that they observed “low vaccine efficacy against infections in health care workers, as well as relatively high viral loads suggesting that those who were infected were infectious.” Bourla: Fourth shot ‘necessary’ The release of the data comes at an awkward time for Pfizer, after a weekend when Bourla said in an interview with CBS’s Face the Nation that a fourth COVID-19 shot would be “necessary” for most people to prevent future infection. Pfizer CEO Albert Bourla in a CBS interview on March 13, 2022. “Right now, the way that we have seen, it is necessary, a fourth booster right now,” Bourla said in the interview. “The protection that you are getting from the third, it is good enough, actually quite good for hospitalizations and deaths. It’s not that good against infections, but doesn’t last very long.” While Bourla said Pfizer had submitted data on the efficacy of the fourth shot to the US FDA, the data has not yet been publicly released. 1. A fourth dose of the Covid-19 vaccine is necessary for most people due to waning immunity, said Pfizer CEO Albert Bourla. He noted that the regimen of two doses plus a booster is not able to offer sufficient protection against new variants. pic.twitter.com/XPCFwiqluD — BFM News (@NewsBFM) March 14, 2022 The US Centers for Disease Control and Prevention currently recommends three jabs for everyone age 12 years and up, and two shots for children between the ages of five and 11. Individuals who are immunocompromised are encouraged to get an extra dose. Fourth dose still protects against severe infection, separate study found A separate Israeli study published, on February 1 by the Israeli Health Ministry, offered somewhat contradictory results to the Sheba findings – although the Ministry of Health study focused only on older people. That study, released on the pre-print biomedical website MedRXiv, found that rates of confirmed COVID-19 infection, as well as severe illness, were lower following a fourth dose, when compared to only three doses. Specifically, the team looked at data from 1,138,681 persons aged over 60 years and eligible for the fourth dose between January 15 and 27, 2022 – the height of the Omicron wave in Israel. They compared the rate of confirmed COVID infections and severe COVID illness between those who took a fourth jab at least 12 days earlier and those who only had three doses, or alternatively those who became ill less than a week after receiving the fourth dose. “The rate of confirmed infection was lower in people 12 or more days after their fourth dose than among those who received only three doses and those 3 to 7 days after vaccination by factors of 2.0 and 1.9, respectively. The rate of severe illness was lower by factors of 4.3 and 4.0,” the authors wrote. ‘Vaccines don’t prevent infection’ Professor Cyrille Cohen, head of the immunology lab at Bar-Ilan University, said that the findings from the Sheba study are not surprising; “the vaccines are not good enough to prevent infection, and even more so with the Omicron variant,” he said. However, like Regev-Yochay, Cohen stressed that there is a growing body of data that shows there remains a substantial difference in the levels of protection acquired by people who are vaccinated with two doses and those who get three doses, when it comes to developing severe disease. “Look at the ratio between people age 60 who got three doses and people that were not vaccinated and got two doses. Even with Omicron, the third dose can reduce the chance of developing severe disease by a factor of four or five and for people above 60 that number becomes 10 to 20,” Cohen said. He also noted that a fourth dose also may help the most vulnerable, noting that today, the serious cases in Israel still tend to be older people with comorbidities or unvaccinated people. “Based on that, a fourth dose for selected populations might demonstrate a benefit,” he said. When asked about Bourla’s statement, Cohen said “it was not clear” and that perhaps the Pfizer CEO was referring to people receiving a shot of the Omicron-adapted vaccine, for which data has not yet been released. A multi-country clinical trial of that vaccine is now underway, including a trial arm in Israel. “I am personally extremely curious to see those results,” Cohen said. Image Credits: Screenshot. Attacks on Health Facilities Are Becoming ‘Part of War Strategy’ in Conflict Zones, Warns WHO 16/03/2022 Kerry Cullinan Attacks on health facilities appear to be part of a deliberate war strategy in Ukraine and other recent conflicts, according to the head of the World Health Organization (WHO) health emergencies programme. The WHO has verified 43 attacks on Ukrainian health facilities since Russia’s invasion on 24 February – and it expects further attacks as over 300 health facilities in conflict areas or under Russian control and a further 600 facilities within 10 kilometres of conflict. But WHO Director-General Dr Tedros Adhanom Ghebreyesus told a media briefing on Wednesday that there had also been 46 attacks on health facilities worldwide since the start of 2022, and people caught in conflicts in Tigray, Yemen and Syria were in extreme need of humanitarian assistance. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme, said that in these conflict zones, attacks on health facilities appeared to be deliberate – in complete violation of international law. “We have never seen this rate of attacks on health care, and health care becoming a target in these situations. It’s becoming part of the strategy and tactics of war and it is entirely unacceptable,” said Ryan. “Under international humanitarian law. conflicting parties are actually instructed to specifically take measures to avoid attacking or inadvertently destroying or hurting health workers or health facilities. They don’t bear responsibility not just to not attack. They actually bear responsibility to ensure that they don’t attack to identify those facilities, to deconflict those facilities and to ensure that they do not, as part of their prosecution of war, attack those facilities,” he added. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme. Multiple conflicts out of the global eye “Although Ukraine is the focus of the world’s attention, it’s far from the only crisis to which WHO is responding,” said Tedros. “In Yemen, roughly two-thirds of the population – more than 20 million people – are estimated to be in need of health assistance. In Afghanistan, more than half the population is in need, with widespread malnutrition and a surge in measles among many other challenges. “And in Ethiopia, six million people in Tigray have been under blockade by Ethiopian and Eritrean forces for almost 500 days, sealed off from the outside world. There is almost no fuel, no cash and no communications. No food aid has been delivered since the middle of December and 83% of the population is food insecure,” said Tedros, who is from Tigray and added his family and friends were affected by the blockade. Aid to Ukraine – but little for Tigray WHO Director-General Dr Tedros Adhanom Ghebreyesus. The WHO has been able to deliver about 100 metric tonnes of supplies to Ukraine, including oxygen, insulin, surgical supplies, anaesthetics and blood transfusion kits; oxygen generators, electrical generators and defibrillators. However, it had only received $8million of the $57.5 million it needed to support Ukraine. In contrast, however, it had only been able to airlift 33 metric tonnes of medicines and other supplies to Tigray in December – enough for 300,000 people – after being denied access to the territory since last July. “We estimate that 2,200 metric tonnes of emergency health supplies are needed to respond to urgent health needs in Tigray,” said Tedros. Treatment for 46,000 Tigrayan people living with HIV has been abandoned, as has treatment for people with cancer, diabetes, hypertension and tuberculosis. “The situation in Tigray is catastrophic. The blockade on communications, including on journalists being able to report from Tigray, means it remains a forgotten crisis. Out of sight and out of mind,” added Tedros. “Just as we continue to call on Russia to make peace in Ukraine, so we continue to call on Ethiopia and Eritrea to end the blockade, the siege, and allow safe access for humanitarian supplies and workers to save lives,” said Tedros. Global COVID-19 cases rise again Meanwhile, after weeks of global decline COVID-19 cases are on the rise again, especially in parts of Asia. “In the last week, we saw an 8% increase in cases detected with more than 11 million cases reported to WHO despite a significant reduction in testing that’s occurring worldwide,” said WHO COVID-19 lead Dr Maria van Kerkhove. She ascribed the increase to the spread of the Omicron variant – particularly the BA.2 lineage which is “the most transmissible variant we have seen of the SARS Co-V2 virus to date” – in a context where restrictions were being lifted globally. Ryan added that the virus would move from one “pocket of susceptibility” where immunity was waning to another. “The likelihood is that this virus will echo around the world,” said Ryan. “It will pick up pockets of susceptibility and will survive in those pockets for months and months until another pocket of susceptibility opens up,” said Ryan. “This is how viruses work. They establish themselves within a community and they will move quickly to the next community that’s unprotected. If communities around the virus are well protected, the virus can sustain itself, even in small communities. It can stay there, it can rest there, and then wait until susceptibility grows.” Image Credits: Markus Spiske/ Unsplash. WTO Head Welcomes Compromise on IP Waiver for COVID Vaccines – But Activists and Pharma Express Dismay 16/03/2022 Kerry Cullinan WTO members last week in session at the TRIPS Council, which has been debating a controversial proposal for an IP waiver on COVID products for over a year. The World Trade Organization’s (WTO) Director-Genera, Dr Ngozi Okonjo-Iweala has “warmly welcomed” the breakthrough reached this week over a waiver on intellectual property for the production of COVID-19 vaccines. “This is a major step forward and this compromise is the result of many long and difficult hours of negotiations. But we are not there yet. We have more work to do to ensure that we have the support of the entire WTO Membership,” said Okonjo-Iweala, in a statement on Wednesday. The agreement reached between the European Union, India, South Africa and the United States – referred to in some quarters as “the Quad” – still needs to be put to all 164 WTO members, which typically decides by consensus. However, the compromise now has good chances of being approved since EU countries had been the major opponents to the proposal by South Africa and India, submitted in October 2020, to waive IP on COVID-19 vaccines and other pandemic-related health products for the duration of the pandemic. Major concessions South Africa and India had to make major conceessions – both narrowing the waiver to only vaccines, as well as narrowing the list of countries that would be eligible to take advantage of the waiver on patents and other IP. “My team and I have been working hard for the past three months and we are ready to roll up our sleeves again to work together with the TRIPS Council Chair Ambassador Lansana Gberie (Sierra Leone) to bring about a full agreement as quickly as possible. We are grateful to the four Members for the difficult work they have undertaken so far,” said Okonjo-Iweala. The WTO’s Ministerial Council (MC12), postponed from late November to the week of June 13, could potentially approve the waiver move – although the date of that meeting has also been cast into doubt due to the recent outbreak of war in the Ukraine. However, the draft text of the proposed compromise, published by STAT News Tuesday evening, has elicited dismay from both health activists and the pharmaceutical industry – for not going far enough, or for going too far. Restricted to vaccines and certain developing countries In essence, the compromise does three things: Most critically, the new waiver would allow developing countries to not only manufacture, but also to export, generic versions of COVID vaccines that are still under patent protection. Currently, Article 31.f of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement restricts such generic manufacture to health products that are “predominantly for the supply of the domestic market” – leaving low-income countries with no manufacturing base unable to import cheaper generic versions of products from abroad. However, the waiver would be limited to countries that exported less than 10% of the world’s vaccines in 2021. That effectively excludes well-established manufacturers in China, but not India, from waiver eligibility. In contrast to the original Indian-South African proposal, the new IP flexibilities are restricted to COVID vaccines, thus excluding COVID treatments such as new antivirals that are particularly important for countries with low vaccination rates, as well as tests, personal protective equipment (PPE) and other pandemic-related goods. Adam Hodge, spokesperson for US Trade Representative Ambassador Katherine Tai, said late Tuesday that the “compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome” after a “difficult and protracted process”. Since last May @USTradeRep has worked hard to facilitate an outcome on IP that can achieve consensus across the 164 @WTO Members to help end the pandemic. USTR joined informal discussions led by the WTO Secretariat with South Africa, India, and the EU to try & break the deadlock. — USTR Office of Public Affairs (@USTRSpox) March 15, 2022 He and others cautioned that details of a final text were yet to be concluded. “While no agreement on text has been reached and we are in the process of consulting on the outcome, the US will continue to engage with WTO Members as part of our comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible,” added Hodge. The informal discussions, led by the WTO Secretariat, have been trying to break the deadlock between the India-South Africa waiver proposal (supported by the Africa and Least Developed Nations groups and others) and the EU’s counter-proposal. India-South Africa proposal had sought a broad waiver on all vaccines, tests and treatments, while the EU had pushed for technical modifications in the existing TRIPS rules. Medicines access activists and pharma leaders both express dismay Both activists and industry reacted with dismay to news of the proposed agreement. For example, the US-based consumer advocacy group, Public Citizen, called on WTO member states to reject the proposal. “Among its key limitations: the proposal appears to cover only vaccines (not tests and treatments), cover only patents (not other important intellectual property barriers), be limited geographically, and further undermine current WTO flexibilities for compulsory licenses,” according to Melinda St Louis, director of Public Citizen’s Global Trade Watch division. “It would be a mistake for WTO members to prematurely agree to a weakened waiver that provides political cover to the US and EU while not making any meaningful difference in increasing access to vaccines, tests and treatments. No waiver is better than a weak waiver designed solely to save face,” added St Louis. Knowledge Ecology International also expressed disquiet, saying that the waiver may even restrict certain flexibilities that are already allowed by Article 31 of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), regarding a country’s rights to manufacture and export generic versions of drugs or vaccines during a health emergency. “Countries are required to follow Article 31 of the TRIPS [agreement], which of course, is an existing and not a new flexibility, but with ‘clarifications’,” noted KEI’s Director, James Love. However, those “clarifications”, also come with new obligations that could make Article 31 “more restrictive and burdensome”, such as a new obligation for a country to identify all of the patents to which it is applying an IP waiver, and to notify the WTO of its use of the waiver – something not required for the issuance of compulsory licenses in general. On the other hand, the draft agreement makes a first-ever reference to a 2005 WHO/UNDP guidance on payments by developing countries to the original patent-holder, which embraces the concept of “tiered royalties”, based on a country’s ability to pay, and authored by Love himself. Pharma says agreement sends ‘wrong signal’ Meanwhile, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said that “weakening patents now when it is widely acknowledged that there are no longer supply constraints of COVID-19 vaccines, sends the wrong signal”. “When the IP TRIPS Waiver was first proposed in 2020, it was to the wrong solution to the problem of scaling up manufacturing of potential COVID-19 vaccines which at the time had not yet even been authorized,” said the IFPMA. “Now the problem of supply has been addressed thanks to unprecedented collaboration involving companies from industrialized and developing countries, the TRIPS Waiver is not only the wrong solution, it is also an outdated proposal, that has been overtaken by events.” It added that the TRIPS waiver proposal is “political posturing that are at best a distraction, at worse creating uncertainty that can undermine innovation’s ability to respond to the current and future response to pandemics”. “The current proposals should be shelved; and the focus should be directed, to admittedly more difficult actions that will change lives for the better: supporting country readiness, contributing to equitable distribution, and driving innovation,” the IFPMA concluded. The final text of any agreement would first need to be approved by the WTO TRIPS Council, and then go before the MC12 for final approval. The TRIPS Council last met on 9-10 March, but at the time failed to reach a compromise – although some sources noted that the were close to agreement as the “Quad” of India, South Africa, the United States and the EU scrambled to reach a deal. According to a WTO statement on 10 March, the TRIPS Council had agreed to keep the agenda item on the IP waiver open – so as to enable the council to be “reconvened at short notice if substantial progress is made in the high-level talks”. TRIPS Council approval would pave the way for a consensus agreement at the WTO’s Ministerial meeting, MC12. Russian Soldiers Hold Health Workers and Patients Hostage at Mariupol Hospital, says Human Rights Group 15/03/2022 Kerry Cullinan Mariupol Regional Hospital before it was bombed Health workers, patients and civilians have been held hostage at the Mariupol regional intensive care hospital in Ukraine by Russian troops since Monday morning, according to the Media Initiative for Human Rights (MIHR). Russian soldiers are using the hospital as a base to attack Ukrainian forces, and using the hostages as “human shields” according to MIHR, a respected human rights monitoring group in Ukraine. “We received information from a doctor from the hospital. We can’t name him because of the threat to him. More information will be available after the person is safe,” the MIHR reported on its Facebook page. Pavlo Kyrylenko, head of the Donetsk regional administration, also reported the hostage situation on his Telegram account. Kyrylenko reported that a hostage had told him: “It is impossible to leave the hospital. There is heavy shelling. We sit in the basement. Cars have not been able to drive into the hospital for two days. High-rise buildings are burning around… Russians rushed 400 people from neighbouring houses to our hospital. We can’t leave. “ While the 550-bed tertiary hospital, the biggest in the Donetsk region, has suffered extensive damage, health workers have continued to attend to patients from the basement. “I appeal to international human rights organizations to respond to these vicious violations of the norms and customs of war, to these egregious crimes against humanity,” said Kyrylenko. Humanitarian groups have been appealing for days for a safe passage corridor to and from Mariupol. Some private cars were finally able to leave the city on Monday and Tuesday, the first time in 10 days. But Russian troops that have beseiged the city on all sides have not allowed relief workers to bring in desperately needed medical supplies, food or water. Mariupol. Direct strike of Russian troops at the maternity hospital. People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror? Close the sky right now! Stop the killings! You have power but you seem to be losing humanity. pic.twitter.com/FoaNdbKH5k — Volodymyr Zelenskyy / Володимир Зеленський (@ZelenskyyUa) March 9, 2022 Last week, Russian troops bombed the Mariupol maternity hospital, reportedly killing at least three people. A pregnant woman evacuated from the hospital and her baby later died from their injuries. Mariupol’s deputy mayor, Sergey Orlov, told France24 on Tuesday that at least 2,358 people had been killed during the 11-day siege of the south-eastern city, and he had been fielding desperate calls from people trapped in basements without food or water. While small numbers of people escaped the besieged city on Monday after a series of failed evacuation attempts, as many as 2,500 civilians have died in Mariupol, Ukrainian officials estimate https://t.co/1ksWTFnzaf — CNN International (@cnni) March 15, 2022 ‘Act of unconscionable cruelty’ The World Health Organization (WHO) has verified 31 attacks on health facilities between the start of the Russian invasion on 24 February and 11 March, resulting in 12 deaths and 34 injuries, of which 8 of the injured and 2 of those killed were health workers. My hometown Volnovakha. I was born at this hospital. Now it’s officially denazified and liberated by Russia. pic.twitter.com/nV9lyZX4uQ — Illia Ponomarenko 🇺🇦 (@IAPonomarenko) March 15, 2022 “We call for an immediate cessation of all attacks on health care in Ukraine. These horrific attacks are killing and causing serious injuries to patients and health workers, destroying vital health infrastructure and forcing thousands to forgo accessing health services despite catastrophic needs,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, UNICEF Executive Director Catherine Russell and UNFPA Executive Director Dr Natalia Kanem, in a joint statement on Sunday. “To attack the most vulnerable – babies, children, pregnant women, and those already suffering from illness and disease, and health workers risking their own lives to save lives – is an act of unconscionable cruelty,” they added. “We must be able to safely deliver emergency medical supplies – including those required for obstetric and neonatal care – to health centers, temporary facilities and underground shelters.” Intentionally attacking health facilities is prohibited under international humanitarian law. Unusual position of surrogates Since the start of the war, more than 4,300 Ukrainian women have given birth, and 80,000 others are expected to give birth in the next three months. “Oxygen and medical supplies, including for the management of pregnancy complications, are running dangerously low,” according to the three leaders. “Many pregnant women may need health care, medication and assistance on a daily basis or when complications with pregnancy occur. When medical facilities are not accessible, are destroyed, or health care personnel and medical product are scarce or unavailable, maternal health can be endangered,” according to Eszther Kisomodi and Emma Pitchford, the chief executive and executive editor respectively of the journal, Sexual and Reproductive Health Matters. They also warned that many pregnant women might be in “particular and unusual situations” as Ukraine “is an international surrogacy hub, one of only a handful of countries in the world that legally allows foreigners to enter into surrogacy arrangements”. https://twitter.com/thedalstonyears/status/1501861609446289410 “Being a surrogate is a job in Ukraine for many women, but not one that they can quit, or even put on hold. Very serious questions occur for all parties in this arrangement – for the pregnant women, the newborn child and the intended parents.” The authors also highlight the precarious position of people with disabilities who cannot move easily, LBGTQ people in the face of hostile Russian forces, and people living with HIV in Ukraine, which has the second-highest infection rate in Europe. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates 17/03/2022 Elaine Ruth Fletcher Pfizer’s Paxlovid, an oral antiviral approved by the US FDA in December, has shown 90% efficacy in preventing mortality among those who take it in the first few days of infection. A Medicines Patent Pool (MPP) announcement Thursday that it has signed agreements with 35 companies to manufacture generic versions of Pfizer’s life-saving COVID-19 Paxlovid treatment for distribution in 95 low- and middle-income countries came fire almost immediately from medicines access groups as too little, too late. The MPP-brokered sublicences follow on from an agreement between MPP and Pfizer in November 2021 to supply generic versions of Pfizer patented main drug ingredient, nirmatrelvir, at cost, to countries that represent about 53% of the world’s population. However, activists quickly slammed with the new accord – saying that it would take up many months to actually set up the generic production lines of the game-changing oral drug, which in clinical trials, reduced COVID mortality by 90% among high risk groups. Mapping of the MPP-brokered licenses awarded for manufacture of a generic version of Paxlovid In a joint letter to Pfizer CEO Albert Bourla, delivered Wednesday, a consortium of 100 activist groups, including Amnesty International and Oxfam, said that Pfizer should immediately dedicate two-thirds of the company’s available patented drug supply to low- and middle-income countries, “where there is a proportionate need.” “At present, Pfizer has preferentially sold all of its Paxlovid doses from the first half of 2022 to a handful of high-income countries, and has tentatively promised to supply only 10 million courses of treatment of LMICs,” stated the Health Global Access Project (Health Gap), one of the signatories to Wednesday’s letter, in a follow-up blog posted online just after the MPP announcement. The activists also have slammed the still high price of the new drug in upper-middle and high income countries, saying that this also creates barriers to access. The United States is paying about $530 a day for a five-day course, although Pfizer has committed to a 3-tiered pricing system with lower costs to less affluent countries. “This announcement will do nothing to eliminate the monopoly Pfizer maintains over unlicensed countries – all high-income and almost all upper-middle income countries, representing 47% of the world’s population and historically experiencing the highest rates of COVID-19 infection,” added Brook Baker, Health Gap Senior Policy Analyst and a Professor at Northeastern University School of Law. MSF – A ‘positive step’ forward Médecins Sans Frontières sounded a more positive note, however, saying that the Pfizer agreement with 35 generics manufacturers in 12 countries represents a “positive step toward addressing the ongoing access challenges for this COVID treatment. However, the limitations of the deal remain concerning.” “The limited global supply from the US corporation Pfizer has so far largely been bought up by a number of high-income countries. It is estimated that generic manufacturers will not be able to bring supply to the market until 2023,” stated MSF. Replying to the criticism, an MPP spokesperson stressed that the new agreement “includes all low and lower-middle-income countries as well as some upper-middle income countries in Sub-Saharan Africa that have transitioned to upper-middle-income status in the past five years. The 53% of the world’s population covered by the licenses, “which is equivalent to about 4.1 billion people. As with all our licences we will continue to explore opportunities to broaden geographic scope, where possible,” the MPP spokesperson added. Design of MPP agreement According to MPP, the non-exclusive sublicence deals will allow generic manufacturers to produce the raw ingredients for Paxlovid’s main active ingredient, nirmatrelvir, and/or the finished drug itself, which is co-packaged with a common HIV drug, ritonavir. It said that six companies will focus on producing the drug substance, nine companies will produce the finished drug product and the remainder will do both. The manufacturers are based in 12 countries including: Bangladesh, Brazil, China, Dominican Republic, Jordan, India, Israel, Mexico, Pakistan, Serbia, Republic of Korea, and Vietnam. “A licence has also been offered to a company in Ukraine, the offer will remain available to them as they are not able to sign due to the current conflict,” MPP said. The deal signed between MPP and Pfizer in November 2021 established the terms and conditions, for the generic licenses, MPP added. Following that, “The requests for sublicences from generic producers were reviewed by MPP and presented to Pfizer,” for its approval – one of the conditions of the sale. Pfizer will not receive royalties from sales of nirmatrelvir from the MPP-negotiated sublicensees for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization, MPP added. Following the pandemic period, sales to low-income countries will remain royalty free, lower-middle-income countries and upper-middle-income countries will be subject to a 5% royalty for sales to the public sector and a 10% royalty for sales to the private sector. “Nirmatrelvir is a new product and requires substantial manufacturing capabilities to produce, and we have been very impressed with the quality of manufacturing demonstrated by these companies,” said Charles Gore, MPP Executive Director. “Furthermore, 15 companies are signing their first licence with MPP, and we warmly welcome our new generic manufacturing partners.” “We have established a comprehensive strategy in partnership with worldwide governments, international global health leaders and global manufacturers to help ensure access to our oral COVID-19 treatment for patients in need around the world, said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “The MPP sublicensees and the additional capacity for COVID-19 treatment they will supply will play a critical role to help ensure that people everywhere, particularly those living in the poorest parts of the world, have equitable access to an oral treatment option against COVID-19.” Image Credits: Pfizer , Medicines Patent Pool . Fourth COVID Vaccine Jab Provides Little Extra Protection to Healthy Individuals – NEJM 16/03/2022 Maayan Hoffman A month after a fourth dose of the Pfizer or Moderna vaccines was administered to hundreds of people in an Israeli clinical trial, authors of the new study on the extra booster say it provides “little protection, if any, from infection by COVID-19 among vaccinated young and healthy individuals in comparison to those vaccinated with only a third dose.” Result of the open-label study, conducted at Israel’s Sheba Medical Center, were published Wednesday evening in the New England Journal of Medicine as a correspondence. The findings contradict statements made by Pfizer CEO Albert Bourla over the weekend that a fourth booster dose could necessary for most people, due to waning immunity. Bourla made the statement as Pfizer seeks quick US Food and Drug Administration approval of a fourth dose, effectively a second booster, for people 65 and older. The new Sheba study included approximately 600 volunteers, among them 270 who received a fourth shot of either the Moderna or Pfizer vaccine. All of the volunteers had received three shots of the Pfizer vaccine prior to the trial. Sheba’s Professor Gili Regev-Yochay, lead author of the study, said in a statement that COVID infection rates among four-time vaccinated individuals were only slightly lower than those in the control group. However, she added that the fourth jab did provide moderate protection against symptomatic infection among young and healthy individuals, in comparison to those who had only received three jabs. “We found no differences, both in terms of IgG antibody levels and in terms of neutralizing antibody levels,” added Regev-Yochay, referring to the impact of the fourth jab on the study group in comparison to the control. “It should be emphasized that the third dose is extremely important for anyone who has not yet contracted COVID-19,” Regev-Yochay stressed, “and the fourth dose is most likely important for populations with risk factors, for which a fourth vaccine would protect from serious illness.” The NEJM correspondence, however, said that the fourth dose was “immunogenic, safe and somewhat efficacious”, adding that “our results suggest that maximal immunogenicity of mRNA vaccines is achieved after three doses and that antibody levels can be restored by a fourth dose.” The researchers added that they observed “low vaccine efficacy against infections in health care workers, as well as relatively high viral loads suggesting that those who were infected were infectious.” Bourla: Fourth shot ‘necessary’ The release of the data comes at an awkward time for Pfizer, after a weekend when Bourla said in an interview with CBS’s Face the Nation that a fourth COVID-19 shot would be “necessary” for most people to prevent future infection. Pfizer CEO Albert Bourla in a CBS interview on March 13, 2022. “Right now, the way that we have seen, it is necessary, a fourth booster right now,” Bourla said in the interview. “The protection that you are getting from the third, it is good enough, actually quite good for hospitalizations and deaths. It’s not that good against infections, but doesn’t last very long.” While Bourla said Pfizer had submitted data on the efficacy of the fourth shot to the US FDA, the data has not yet been publicly released. 1. A fourth dose of the Covid-19 vaccine is necessary for most people due to waning immunity, said Pfizer CEO Albert Bourla. He noted that the regimen of two doses plus a booster is not able to offer sufficient protection against new variants. pic.twitter.com/XPCFwiqluD — BFM News (@NewsBFM) March 14, 2022 The US Centers for Disease Control and Prevention currently recommends three jabs for everyone age 12 years and up, and two shots for children between the ages of five and 11. Individuals who are immunocompromised are encouraged to get an extra dose. Fourth dose still protects against severe infection, separate study found A separate Israeli study published, on February 1 by the Israeli Health Ministry, offered somewhat contradictory results to the Sheba findings – although the Ministry of Health study focused only on older people. That study, released on the pre-print biomedical website MedRXiv, found that rates of confirmed COVID-19 infection, as well as severe illness, were lower following a fourth dose, when compared to only three doses. Specifically, the team looked at data from 1,138,681 persons aged over 60 years and eligible for the fourth dose between January 15 and 27, 2022 – the height of the Omicron wave in Israel. They compared the rate of confirmed COVID infections and severe COVID illness between those who took a fourth jab at least 12 days earlier and those who only had three doses, or alternatively those who became ill less than a week after receiving the fourth dose. “The rate of confirmed infection was lower in people 12 or more days after their fourth dose than among those who received only three doses and those 3 to 7 days after vaccination by factors of 2.0 and 1.9, respectively. The rate of severe illness was lower by factors of 4.3 and 4.0,” the authors wrote. ‘Vaccines don’t prevent infection’ Professor Cyrille Cohen, head of the immunology lab at Bar-Ilan University, said that the findings from the Sheba study are not surprising; “the vaccines are not good enough to prevent infection, and even more so with the Omicron variant,” he said. However, like Regev-Yochay, Cohen stressed that there is a growing body of data that shows there remains a substantial difference in the levels of protection acquired by people who are vaccinated with two doses and those who get three doses, when it comes to developing severe disease. “Look at the ratio between people age 60 who got three doses and people that were not vaccinated and got two doses. Even with Omicron, the third dose can reduce the chance of developing severe disease by a factor of four or five and for people above 60 that number becomes 10 to 20,” Cohen said. He also noted that a fourth dose also may help the most vulnerable, noting that today, the serious cases in Israel still tend to be older people with comorbidities or unvaccinated people. “Based on that, a fourth dose for selected populations might demonstrate a benefit,” he said. When asked about Bourla’s statement, Cohen said “it was not clear” and that perhaps the Pfizer CEO was referring to people receiving a shot of the Omicron-adapted vaccine, for which data has not yet been released. A multi-country clinical trial of that vaccine is now underway, including a trial arm in Israel. “I am personally extremely curious to see those results,” Cohen said. Image Credits: Screenshot. Attacks on Health Facilities Are Becoming ‘Part of War Strategy’ in Conflict Zones, Warns WHO 16/03/2022 Kerry Cullinan Attacks on health facilities appear to be part of a deliberate war strategy in Ukraine and other recent conflicts, according to the head of the World Health Organization (WHO) health emergencies programme. The WHO has verified 43 attacks on Ukrainian health facilities since Russia’s invasion on 24 February – and it expects further attacks as over 300 health facilities in conflict areas or under Russian control and a further 600 facilities within 10 kilometres of conflict. But WHO Director-General Dr Tedros Adhanom Ghebreyesus told a media briefing on Wednesday that there had also been 46 attacks on health facilities worldwide since the start of 2022, and people caught in conflicts in Tigray, Yemen and Syria were in extreme need of humanitarian assistance. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme, said that in these conflict zones, attacks on health facilities appeared to be deliberate – in complete violation of international law. “We have never seen this rate of attacks on health care, and health care becoming a target in these situations. It’s becoming part of the strategy and tactics of war and it is entirely unacceptable,” said Ryan. “Under international humanitarian law. conflicting parties are actually instructed to specifically take measures to avoid attacking or inadvertently destroying or hurting health workers or health facilities. They don’t bear responsibility not just to not attack. They actually bear responsibility to ensure that they don’t attack to identify those facilities, to deconflict those facilities and to ensure that they do not, as part of their prosecution of war, attack those facilities,” he added. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme. Multiple conflicts out of the global eye “Although Ukraine is the focus of the world’s attention, it’s far from the only crisis to which WHO is responding,” said Tedros. “In Yemen, roughly two-thirds of the population – more than 20 million people – are estimated to be in need of health assistance. In Afghanistan, more than half the population is in need, with widespread malnutrition and a surge in measles among many other challenges. “And in Ethiopia, six million people in Tigray have been under blockade by Ethiopian and Eritrean forces for almost 500 days, sealed off from the outside world. There is almost no fuel, no cash and no communications. No food aid has been delivered since the middle of December and 83% of the population is food insecure,” said Tedros, who is from Tigray and added his family and friends were affected by the blockade. Aid to Ukraine – but little for Tigray WHO Director-General Dr Tedros Adhanom Ghebreyesus. The WHO has been able to deliver about 100 metric tonnes of supplies to Ukraine, including oxygen, insulin, surgical supplies, anaesthetics and blood transfusion kits; oxygen generators, electrical generators and defibrillators. However, it had only received $8million of the $57.5 million it needed to support Ukraine. In contrast, however, it had only been able to airlift 33 metric tonnes of medicines and other supplies to Tigray in December – enough for 300,000 people – after being denied access to the territory since last July. “We estimate that 2,200 metric tonnes of emergency health supplies are needed to respond to urgent health needs in Tigray,” said Tedros. Treatment for 46,000 Tigrayan people living with HIV has been abandoned, as has treatment for people with cancer, diabetes, hypertension and tuberculosis. “The situation in Tigray is catastrophic. The blockade on communications, including on journalists being able to report from Tigray, means it remains a forgotten crisis. Out of sight and out of mind,” added Tedros. “Just as we continue to call on Russia to make peace in Ukraine, so we continue to call on Ethiopia and Eritrea to end the blockade, the siege, and allow safe access for humanitarian supplies and workers to save lives,” said Tedros. Global COVID-19 cases rise again Meanwhile, after weeks of global decline COVID-19 cases are on the rise again, especially in parts of Asia. “In the last week, we saw an 8% increase in cases detected with more than 11 million cases reported to WHO despite a significant reduction in testing that’s occurring worldwide,” said WHO COVID-19 lead Dr Maria van Kerkhove. She ascribed the increase to the spread of the Omicron variant – particularly the BA.2 lineage which is “the most transmissible variant we have seen of the SARS Co-V2 virus to date” – in a context where restrictions were being lifted globally. Ryan added that the virus would move from one “pocket of susceptibility” where immunity was waning to another. “The likelihood is that this virus will echo around the world,” said Ryan. “It will pick up pockets of susceptibility and will survive in those pockets for months and months until another pocket of susceptibility opens up,” said Ryan. “This is how viruses work. They establish themselves within a community and they will move quickly to the next community that’s unprotected. If communities around the virus are well protected, the virus can sustain itself, even in small communities. It can stay there, it can rest there, and then wait until susceptibility grows.” Image Credits: Markus Spiske/ Unsplash. WTO Head Welcomes Compromise on IP Waiver for COVID Vaccines – But Activists and Pharma Express Dismay 16/03/2022 Kerry Cullinan WTO members last week in session at the TRIPS Council, which has been debating a controversial proposal for an IP waiver on COVID products for over a year. The World Trade Organization’s (WTO) Director-Genera, Dr Ngozi Okonjo-Iweala has “warmly welcomed” the breakthrough reached this week over a waiver on intellectual property for the production of COVID-19 vaccines. “This is a major step forward and this compromise is the result of many long and difficult hours of negotiations. But we are not there yet. We have more work to do to ensure that we have the support of the entire WTO Membership,” said Okonjo-Iweala, in a statement on Wednesday. The agreement reached between the European Union, India, South Africa and the United States – referred to in some quarters as “the Quad” – still needs to be put to all 164 WTO members, which typically decides by consensus. However, the compromise now has good chances of being approved since EU countries had been the major opponents to the proposal by South Africa and India, submitted in October 2020, to waive IP on COVID-19 vaccines and other pandemic-related health products for the duration of the pandemic. Major concessions South Africa and India had to make major conceessions – both narrowing the waiver to only vaccines, as well as narrowing the list of countries that would be eligible to take advantage of the waiver on patents and other IP. “My team and I have been working hard for the past three months and we are ready to roll up our sleeves again to work together with the TRIPS Council Chair Ambassador Lansana Gberie (Sierra Leone) to bring about a full agreement as quickly as possible. We are grateful to the four Members for the difficult work they have undertaken so far,” said Okonjo-Iweala. The WTO’s Ministerial Council (MC12), postponed from late November to the week of June 13, could potentially approve the waiver move – although the date of that meeting has also been cast into doubt due to the recent outbreak of war in the Ukraine. However, the draft text of the proposed compromise, published by STAT News Tuesday evening, has elicited dismay from both health activists and the pharmaceutical industry – for not going far enough, or for going too far. Restricted to vaccines and certain developing countries In essence, the compromise does three things: Most critically, the new waiver would allow developing countries to not only manufacture, but also to export, generic versions of COVID vaccines that are still under patent protection. Currently, Article 31.f of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement restricts such generic manufacture to health products that are “predominantly for the supply of the domestic market” – leaving low-income countries with no manufacturing base unable to import cheaper generic versions of products from abroad. However, the waiver would be limited to countries that exported less than 10% of the world’s vaccines in 2021. That effectively excludes well-established manufacturers in China, but not India, from waiver eligibility. In contrast to the original Indian-South African proposal, the new IP flexibilities are restricted to COVID vaccines, thus excluding COVID treatments such as new antivirals that are particularly important for countries with low vaccination rates, as well as tests, personal protective equipment (PPE) and other pandemic-related goods. Adam Hodge, spokesperson for US Trade Representative Ambassador Katherine Tai, said late Tuesday that the “compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome” after a “difficult and protracted process”. Since last May @USTradeRep has worked hard to facilitate an outcome on IP that can achieve consensus across the 164 @WTO Members to help end the pandemic. USTR joined informal discussions led by the WTO Secretariat with South Africa, India, and the EU to try & break the deadlock. — USTR Office of Public Affairs (@USTRSpox) March 15, 2022 He and others cautioned that details of a final text were yet to be concluded. “While no agreement on text has been reached and we are in the process of consulting on the outcome, the US will continue to engage with WTO Members as part of our comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible,” added Hodge. The informal discussions, led by the WTO Secretariat, have been trying to break the deadlock between the India-South Africa waiver proposal (supported by the Africa and Least Developed Nations groups and others) and the EU’s counter-proposal. India-South Africa proposal had sought a broad waiver on all vaccines, tests and treatments, while the EU had pushed for technical modifications in the existing TRIPS rules. Medicines access activists and pharma leaders both express dismay Both activists and industry reacted with dismay to news of the proposed agreement. For example, the US-based consumer advocacy group, Public Citizen, called on WTO member states to reject the proposal. “Among its key limitations: the proposal appears to cover only vaccines (not tests and treatments), cover only patents (not other important intellectual property barriers), be limited geographically, and further undermine current WTO flexibilities for compulsory licenses,” according to Melinda St Louis, director of Public Citizen’s Global Trade Watch division. “It would be a mistake for WTO members to prematurely agree to a weakened waiver that provides political cover to the US and EU while not making any meaningful difference in increasing access to vaccines, tests and treatments. No waiver is better than a weak waiver designed solely to save face,” added St Louis. Knowledge Ecology International also expressed disquiet, saying that the waiver may even restrict certain flexibilities that are already allowed by Article 31 of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), regarding a country’s rights to manufacture and export generic versions of drugs or vaccines during a health emergency. “Countries are required to follow Article 31 of the TRIPS [agreement], which of course, is an existing and not a new flexibility, but with ‘clarifications’,” noted KEI’s Director, James Love. However, those “clarifications”, also come with new obligations that could make Article 31 “more restrictive and burdensome”, such as a new obligation for a country to identify all of the patents to which it is applying an IP waiver, and to notify the WTO of its use of the waiver – something not required for the issuance of compulsory licenses in general. On the other hand, the draft agreement makes a first-ever reference to a 2005 WHO/UNDP guidance on payments by developing countries to the original patent-holder, which embraces the concept of “tiered royalties”, based on a country’s ability to pay, and authored by Love himself. Pharma says agreement sends ‘wrong signal’ Meanwhile, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said that “weakening patents now when it is widely acknowledged that there are no longer supply constraints of COVID-19 vaccines, sends the wrong signal”. “When the IP TRIPS Waiver was first proposed in 2020, it was to the wrong solution to the problem of scaling up manufacturing of potential COVID-19 vaccines which at the time had not yet even been authorized,” said the IFPMA. “Now the problem of supply has been addressed thanks to unprecedented collaboration involving companies from industrialized and developing countries, the TRIPS Waiver is not only the wrong solution, it is also an outdated proposal, that has been overtaken by events.” It added that the TRIPS waiver proposal is “political posturing that are at best a distraction, at worse creating uncertainty that can undermine innovation’s ability to respond to the current and future response to pandemics”. “The current proposals should be shelved; and the focus should be directed, to admittedly more difficult actions that will change lives for the better: supporting country readiness, contributing to equitable distribution, and driving innovation,” the IFPMA concluded. The final text of any agreement would first need to be approved by the WTO TRIPS Council, and then go before the MC12 for final approval. The TRIPS Council last met on 9-10 March, but at the time failed to reach a compromise – although some sources noted that the were close to agreement as the “Quad” of India, South Africa, the United States and the EU scrambled to reach a deal. According to a WTO statement on 10 March, the TRIPS Council had agreed to keep the agenda item on the IP waiver open – so as to enable the council to be “reconvened at short notice if substantial progress is made in the high-level talks”. TRIPS Council approval would pave the way for a consensus agreement at the WTO’s Ministerial meeting, MC12. Russian Soldiers Hold Health Workers and Patients Hostage at Mariupol Hospital, says Human Rights Group 15/03/2022 Kerry Cullinan Mariupol Regional Hospital before it was bombed Health workers, patients and civilians have been held hostage at the Mariupol regional intensive care hospital in Ukraine by Russian troops since Monday morning, according to the Media Initiative for Human Rights (MIHR). Russian soldiers are using the hospital as a base to attack Ukrainian forces, and using the hostages as “human shields” according to MIHR, a respected human rights monitoring group in Ukraine. “We received information from a doctor from the hospital. We can’t name him because of the threat to him. More information will be available after the person is safe,” the MIHR reported on its Facebook page. Pavlo Kyrylenko, head of the Donetsk regional administration, also reported the hostage situation on his Telegram account. Kyrylenko reported that a hostage had told him: “It is impossible to leave the hospital. There is heavy shelling. We sit in the basement. Cars have not been able to drive into the hospital for two days. High-rise buildings are burning around… Russians rushed 400 people from neighbouring houses to our hospital. We can’t leave. “ While the 550-bed tertiary hospital, the biggest in the Donetsk region, has suffered extensive damage, health workers have continued to attend to patients from the basement. “I appeal to international human rights organizations to respond to these vicious violations of the norms and customs of war, to these egregious crimes against humanity,” said Kyrylenko. Humanitarian groups have been appealing for days for a safe passage corridor to and from Mariupol. Some private cars were finally able to leave the city on Monday and Tuesday, the first time in 10 days. But Russian troops that have beseiged the city on all sides have not allowed relief workers to bring in desperately needed medical supplies, food or water. Mariupol. Direct strike of Russian troops at the maternity hospital. People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror? Close the sky right now! Stop the killings! You have power but you seem to be losing humanity. pic.twitter.com/FoaNdbKH5k — Volodymyr Zelenskyy / Володимир Зеленський (@ZelenskyyUa) March 9, 2022 Last week, Russian troops bombed the Mariupol maternity hospital, reportedly killing at least three people. A pregnant woman evacuated from the hospital and her baby later died from their injuries. Mariupol’s deputy mayor, Sergey Orlov, told France24 on Tuesday that at least 2,358 people had been killed during the 11-day siege of the south-eastern city, and he had been fielding desperate calls from people trapped in basements without food or water. While small numbers of people escaped the besieged city on Monday after a series of failed evacuation attempts, as many as 2,500 civilians have died in Mariupol, Ukrainian officials estimate https://t.co/1ksWTFnzaf — CNN International (@cnni) March 15, 2022 ‘Act of unconscionable cruelty’ The World Health Organization (WHO) has verified 31 attacks on health facilities between the start of the Russian invasion on 24 February and 11 March, resulting in 12 deaths and 34 injuries, of which 8 of the injured and 2 of those killed were health workers. My hometown Volnovakha. I was born at this hospital. Now it’s officially denazified and liberated by Russia. pic.twitter.com/nV9lyZX4uQ — Illia Ponomarenko 🇺🇦 (@IAPonomarenko) March 15, 2022 “We call for an immediate cessation of all attacks on health care in Ukraine. These horrific attacks are killing and causing serious injuries to patients and health workers, destroying vital health infrastructure and forcing thousands to forgo accessing health services despite catastrophic needs,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, UNICEF Executive Director Catherine Russell and UNFPA Executive Director Dr Natalia Kanem, in a joint statement on Sunday. “To attack the most vulnerable – babies, children, pregnant women, and those already suffering from illness and disease, and health workers risking their own lives to save lives – is an act of unconscionable cruelty,” they added. “We must be able to safely deliver emergency medical supplies – including those required for obstetric and neonatal care – to health centers, temporary facilities and underground shelters.” Intentionally attacking health facilities is prohibited under international humanitarian law. Unusual position of surrogates Since the start of the war, more than 4,300 Ukrainian women have given birth, and 80,000 others are expected to give birth in the next three months. “Oxygen and medical supplies, including for the management of pregnancy complications, are running dangerously low,” according to the three leaders. “Many pregnant women may need health care, medication and assistance on a daily basis or when complications with pregnancy occur. When medical facilities are not accessible, are destroyed, or health care personnel and medical product are scarce or unavailable, maternal health can be endangered,” according to Eszther Kisomodi and Emma Pitchford, the chief executive and executive editor respectively of the journal, Sexual and Reproductive Health Matters. They also warned that many pregnant women might be in “particular and unusual situations” as Ukraine “is an international surrogacy hub, one of only a handful of countries in the world that legally allows foreigners to enter into surrogacy arrangements”. https://twitter.com/thedalstonyears/status/1501861609446289410 “Being a surrogate is a job in Ukraine for many women, but not one that they can quit, or even put on hold. Very serious questions occur for all parties in this arrangement – for the pregnant women, the newborn child and the intended parents.” The authors also highlight the precarious position of people with disabilities who cannot move easily, LBGTQ people in the face of hostile Russian forces, and people living with HIV in Ukraine, which has the second-highest infection rate in Europe. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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Fourth COVID Vaccine Jab Provides Little Extra Protection to Healthy Individuals – NEJM 16/03/2022 Maayan Hoffman A month after a fourth dose of the Pfizer or Moderna vaccines was administered to hundreds of people in an Israeli clinical trial, authors of the new study on the extra booster say it provides “little protection, if any, from infection by COVID-19 among vaccinated young and healthy individuals in comparison to those vaccinated with only a third dose.” Result of the open-label study, conducted at Israel’s Sheba Medical Center, were published Wednesday evening in the New England Journal of Medicine as a correspondence. The findings contradict statements made by Pfizer CEO Albert Bourla over the weekend that a fourth booster dose could necessary for most people, due to waning immunity. Bourla made the statement as Pfizer seeks quick US Food and Drug Administration approval of a fourth dose, effectively a second booster, for people 65 and older. The new Sheba study included approximately 600 volunteers, among them 270 who received a fourth shot of either the Moderna or Pfizer vaccine. All of the volunteers had received three shots of the Pfizer vaccine prior to the trial. Sheba’s Professor Gili Regev-Yochay, lead author of the study, said in a statement that COVID infection rates among four-time vaccinated individuals were only slightly lower than those in the control group. However, she added that the fourth jab did provide moderate protection against symptomatic infection among young and healthy individuals, in comparison to those who had only received three jabs. “We found no differences, both in terms of IgG antibody levels and in terms of neutralizing antibody levels,” added Regev-Yochay, referring to the impact of the fourth jab on the study group in comparison to the control. “It should be emphasized that the third dose is extremely important for anyone who has not yet contracted COVID-19,” Regev-Yochay stressed, “and the fourth dose is most likely important for populations with risk factors, for which a fourth vaccine would protect from serious illness.” The NEJM correspondence, however, said that the fourth dose was “immunogenic, safe and somewhat efficacious”, adding that “our results suggest that maximal immunogenicity of mRNA vaccines is achieved after three doses and that antibody levels can be restored by a fourth dose.” The researchers added that they observed “low vaccine efficacy against infections in health care workers, as well as relatively high viral loads suggesting that those who were infected were infectious.” Bourla: Fourth shot ‘necessary’ The release of the data comes at an awkward time for Pfizer, after a weekend when Bourla said in an interview with CBS’s Face the Nation that a fourth COVID-19 shot would be “necessary” for most people to prevent future infection. Pfizer CEO Albert Bourla in a CBS interview on March 13, 2022. “Right now, the way that we have seen, it is necessary, a fourth booster right now,” Bourla said in the interview. “The protection that you are getting from the third, it is good enough, actually quite good for hospitalizations and deaths. It’s not that good against infections, but doesn’t last very long.” While Bourla said Pfizer had submitted data on the efficacy of the fourth shot to the US FDA, the data has not yet been publicly released. 1. A fourth dose of the Covid-19 vaccine is necessary for most people due to waning immunity, said Pfizer CEO Albert Bourla. He noted that the regimen of two doses plus a booster is not able to offer sufficient protection against new variants. pic.twitter.com/XPCFwiqluD — BFM News (@NewsBFM) March 14, 2022 The US Centers for Disease Control and Prevention currently recommends three jabs for everyone age 12 years and up, and two shots for children between the ages of five and 11. Individuals who are immunocompromised are encouraged to get an extra dose. Fourth dose still protects against severe infection, separate study found A separate Israeli study published, on February 1 by the Israeli Health Ministry, offered somewhat contradictory results to the Sheba findings – although the Ministry of Health study focused only on older people. That study, released on the pre-print biomedical website MedRXiv, found that rates of confirmed COVID-19 infection, as well as severe illness, were lower following a fourth dose, when compared to only three doses. Specifically, the team looked at data from 1,138,681 persons aged over 60 years and eligible for the fourth dose between January 15 and 27, 2022 – the height of the Omicron wave in Israel. They compared the rate of confirmed COVID infections and severe COVID illness between those who took a fourth jab at least 12 days earlier and those who only had three doses, or alternatively those who became ill less than a week after receiving the fourth dose. “The rate of confirmed infection was lower in people 12 or more days after their fourth dose than among those who received only three doses and those 3 to 7 days after vaccination by factors of 2.0 and 1.9, respectively. The rate of severe illness was lower by factors of 4.3 and 4.0,” the authors wrote. ‘Vaccines don’t prevent infection’ Professor Cyrille Cohen, head of the immunology lab at Bar-Ilan University, said that the findings from the Sheba study are not surprising; “the vaccines are not good enough to prevent infection, and even more so with the Omicron variant,” he said. However, like Regev-Yochay, Cohen stressed that there is a growing body of data that shows there remains a substantial difference in the levels of protection acquired by people who are vaccinated with two doses and those who get three doses, when it comes to developing severe disease. “Look at the ratio between people age 60 who got three doses and people that were not vaccinated and got two doses. Even with Omicron, the third dose can reduce the chance of developing severe disease by a factor of four or five and for people above 60 that number becomes 10 to 20,” Cohen said. He also noted that a fourth dose also may help the most vulnerable, noting that today, the serious cases in Israel still tend to be older people with comorbidities or unvaccinated people. “Based on that, a fourth dose for selected populations might demonstrate a benefit,” he said. When asked about Bourla’s statement, Cohen said “it was not clear” and that perhaps the Pfizer CEO was referring to people receiving a shot of the Omicron-adapted vaccine, for which data has not yet been released. A multi-country clinical trial of that vaccine is now underway, including a trial arm in Israel. “I am personally extremely curious to see those results,” Cohen said. Image Credits: Screenshot. Attacks on Health Facilities Are Becoming ‘Part of War Strategy’ in Conflict Zones, Warns WHO 16/03/2022 Kerry Cullinan Attacks on health facilities appear to be part of a deliberate war strategy in Ukraine and other recent conflicts, according to the head of the World Health Organization (WHO) health emergencies programme. The WHO has verified 43 attacks on Ukrainian health facilities since Russia’s invasion on 24 February – and it expects further attacks as over 300 health facilities in conflict areas or under Russian control and a further 600 facilities within 10 kilometres of conflict. But WHO Director-General Dr Tedros Adhanom Ghebreyesus told a media briefing on Wednesday that there had also been 46 attacks on health facilities worldwide since the start of 2022, and people caught in conflicts in Tigray, Yemen and Syria were in extreme need of humanitarian assistance. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme, said that in these conflict zones, attacks on health facilities appeared to be deliberate – in complete violation of international law. “We have never seen this rate of attacks on health care, and health care becoming a target in these situations. It’s becoming part of the strategy and tactics of war and it is entirely unacceptable,” said Ryan. “Under international humanitarian law. conflicting parties are actually instructed to specifically take measures to avoid attacking or inadvertently destroying or hurting health workers or health facilities. They don’t bear responsibility not just to not attack. They actually bear responsibility to ensure that they don’t attack to identify those facilities, to deconflict those facilities and to ensure that they do not, as part of their prosecution of war, attack those facilities,” he added. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme. Multiple conflicts out of the global eye “Although Ukraine is the focus of the world’s attention, it’s far from the only crisis to which WHO is responding,” said Tedros. “In Yemen, roughly two-thirds of the population – more than 20 million people – are estimated to be in need of health assistance. In Afghanistan, more than half the population is in need, with widespread malnutrition and a surge in measles among many other challenges. “And in Ethiopia, six million people in Tigray have been under blockade by Ethiopian and Eritrean forces for almost 500 days, sealed off from the outside world. There is almost no fuel, no cash and no communications. No food aid has been delivered since the middle of December and 83% of the population is food insecure,” said Tedros, who is from Tigray and added his family and friends were affected by the blockade. Aid to Ukraine – but little for Tigray WHO Director-General Dr Tedros Adhanom Ghebreyesus. The WHO has been able to deliver about 100 metric tonnes of supplies to Ukraine, including oxygen, insulin, surgical supplies, anaesthetics and blood transfusion kits; oxygen generators, electrical generators and defibrillators. However, it had only received $8million of the $57.5 million it needed to support Ukraine. In contrast, however, it had only been able to airlift 33 metric tonnes of medicines and other supplies to Tigray in December – enough for 300,000 people – after being denied access to the territory since last July. “We estimate that 2,200 metric tonnes of emergency health supplies are needed to respond to urgent health needs in Tigray,” said Tedros. Treatment for 46,000 Tigrayan people living with HIV has been abandoned, as has treatment for people with cancer, diabetes, hypertension and tuberculosis. “The situation in Tigray is catastrophic. The blockade on communications, including on journalists being able to report from Tigray, means it remains a forgotten crisis. Out of sight and out of mind,” added Tedros. “Just as we continue to call on Russia to make peace in Ukraine, so we continue to call on Ethiopia and Eritrea to end the blockade, the siege, and allow safe access for humanitarian supplies and workers to save lives,” said Tedros. Global COVID-19 cases rise again Meanwhile, after weeks of global decline COVID-19 cases are on the rise again, especially in parts of Asia. “In the last week, we saw an 8% increase in cases detected with more than 11 million cases reported to WHO despite a significant reduction in testing that’s occurring worldwide,” said WHO COVID-19 lead Dr Maria van Kerkhove. She ascribed the increase to the spread of the Omicron variant – particularly the BA.2 lineage which is “the most transmissible variant we have seen of the SARS Co-V2 virus to date” – in a context where restrictions were being lifted globally. Ryan added that the virus would move from one “pocket of susceptibility” where immunity was waning to another. “The likelihood is that this virus will echo around the world,” said Ryan. “It will pick up pockets of susceptibility and will survive in those pockets for months and months until another pocket of susceptibility opens up,” said Ryan. “This is how viruses work. They establish themselves within a community and they will move quickly to the next community that’s unprotected. If communities around the virus are well protected, the virus can sustain itself, even in small communities. It can stay there, it can rest there, and then wait until susceptibility grows.” Image Credits: Markus Spiske/ Unsplash. WTO Head Welcomes Compromise on IP Waiver for COVID Vaccines – But Activists and Pharma Express Dismay 16/03/2022 Kerry Cullinan WTO members last week in session at the TRIPS Council, which has been debating a controversial proposal for an IP waiver on COVID products for over a year. The World Trade Organization’s (WTO) Director-Genera, Dr Ngozi Okonjo-Iweala has “warmly welcomed” the breakthrough reached this week over a waiver on intellectual property for the production of COVID-19 vaccines. “This is a major step forward and this compromise is the result of many long and difficult hours of negotiations. But we are not there yet. We have more work to do to ensure that we have the support of the entire WTO Membership,” said Okonjo-Iweala, in a statement on Wednesday. The agreement reached between the European Union, India, South Africa and the United States – referred to in some quarters as “the Quad” – still needs to be put to all 164 WTO members, which typically decides by consensus. However, the compromise now has good chances of being approved since EU countries had been the major opponents to the proposal by South Africa and India, submitted in October 2020, to waive IP on COVID-19 vaccines and other pandemic-related health products for the duration of the pandemic. Major concessions South Africa and India had to make major conceessions – both narrowing the waiver to only vaccines, as well as narrowing the list of countries that would be eligible to take advantage of the waiver on patents and other IP. “My team and I have been working hard for the past three months and we are ready to roll up our sleeves again to work together with the TRIPS Council Chair Ambassador Lansana Gberie (Sierra Leone) to bring about a full agreement as quickly as possible. We are grateful to the four Members for the difficult work they have undertaken so far,” said Okonjo-Iweala. The WTO’s Ministerial Council (MC12), postponed from late November to the week of June 13, could potentially approve the waiver move – although the date of that meeting has also been cast into doubt due to the recent outbreak of war in the Ukraine. However, the draft text of the proposed compromise, published by STAT News Tuesday evening, has elicited dismay from both health activists and the pharmaceutical industry – for not going far enough, or for going too far. Restricted to vaccines and certain developing countries In essence, the compromise does three things: Most critically, the new waiver would allow developing countries to not only manufacture, but also to export, generic versions of COVID vaccines that are still under patent protection. Currently, Article 31.f of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement restricts such generic manufacture to health products that are “predominantly for the supply of the domestic market” – leaving low-income countries with no manufacturing base unable to import cheaper generic versions of products from abroad. However, the waiver would be limited to countries that exported less than 10% of the world’s vaccines in 2021. That effectively excludes well-established manufacturers in China, but not India, from waiver eligibility. In contrast to the original Indian-South African proposal, the new IP flexibilities are restricted to COVID vaccines, thus excluding COVID treatments such as new antivirals that are particularly important for countries with low vaccination rates, as well as tests, personal protective equipment (PPE) and other pandemic-related goods. Adam Hodge, spokesperson for US Trade Representative Ambassador Katherine Tai, said late Tuesday that the “compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome” after a “difficult and protracted process”. Since last May @USTradeRep has worked hard to facilitate an outcome on IP that can achieve consensus across the 164 @WTO Members to help end the pandemic. USTR joined informal discussions led by the WTO Secretariat with South Africa, India, and the EU to try & break the deadlock. — USTR Office of Public Affairs (@USTRSpox) March 15, 2022 He and others cautioned that details of a final text were yet to be concluded. “While no agreement on text has been reached and we are in the process of consulting on the outcome, the US will continue to engage with WTO Members as part of our comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible,” added Hodge. The informal discussions, led by the WTO Secretariat, have been trying to break the deadlock between the India-South Africa waiver proposal (supported by the Africa and Least Developed Nations groups and others) and the EU’s counter-proposal. India-South Africa proposal had sought a broad waiver on all vaccines, tests and treatments, while the EU had pushed for technical modifications in the existing TRIPS rules. Medicines access activists and pharma leaders both express dismay Both activists and industry reacted with dismay to news of the proposed agreement. For example, the US-based consumer advocacy group, Public Citizen, called on WTO member states to reject the proposal. “Among its key limitations: the proposal appears to cover only vaccines (not tests and treatments), cover only patents (not other important intellectual property barriers), be limited geographically, and further undermine current WTO flexibilities for compulsory licenses,” according to Melinda St Louis, director of Public Citizen’s Global Trade Watch division. “It would be a mistake for WTO members to prematurely agree to a weakened waiver that provides political cover to the US and EU while not making any meaningful difference in increasing access to vaccines, tests and treatments. No waiver is better than a weak waiver designed solely to save face,” added St Louis. Knowledge Ecology International also expressed disquiet, saying that the waiver may even restrict certain flexibilities that are already allowed by Article 31 of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), regarding a country’s rights to manufacture and export generic versions of drugs or vaccines during a health emergency. “Countries are required to follow Article 31 of the TRIPS [agreement], which of course, is an existing and not a new flexibility, but with ‘clarifications’,” noted KEI’s Director, James Love. However, those “clarifications”, also come with new obligations that could make Article 31 “more restrictive and burdensome”, such as a new obligation for a country to identify all of the patents to which it is applying an IP waiver, and to notify the WTO of its use of the waiver – something not required for the issuance of compulsory licenses in general. On the other hand, the draft agreement makes a first-ever reference to a 2005 WHO/UNDP guidance on payments by developing countries to the original patent-holder, which embraces the concept of “tiered royalties”, based on a country’s ability to pay, and authored by Love himself. Pharma says agreement sends ‘wrong signal’ Meanwhile, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said that “weakening patents now when it is widely acknowledged that there are no longer supply constraints of COVID-19 vaccines, sends the wrong signal”. “When the IP TRIPS Waiver was first proposed in 2020, it was to the wrong solution to the problem of scaling up manufacturing of potential COVID-19 vaccines which at the time had not yet even been authorized,” said the IFPMA. “Now the problem of supply has been addressed thanks to unprecedented collaboration involving companies from industrialized and developing countries, the TRIPS Waiver is not only the wrong solution, it is also an outdated proposal, that has been overtaken by events.” It added that the TRIPS waiver proposal is “political posturing that are at best a distraction, at worse creating uncertainty that can undermine innovation’s ability to respond to the current and future response to pandemics”. “The current proposals should be shelved; and the focus should be directed, to admittedly more difficult actions that will change lives for the better: supporting country readiness, contributing to equitable distribution, and driving innovation,” the IFPMA concluded. The final text of any agreement would first need to be approved by the WTO TRIPS Council, and then go before the MC12 for final approval. The TRIPS Council last met on 9-10 March, but at the time failed to reach a compromise – although some sources noted that the were close to agreement as the “Quad” of India, South Africa, the United States and the EU scrambled to reach a deal. According to a WTO statement on 10 March, the TRIPS Council had agreed to keep the agenda item on the IP waiver open – so as to enable the council to be “reconvened at short notice if substantial progress is made in the high-level talks”. TRIPS Council approval would pave the way for a consensus agreement at the WTO’s Ministerial meeting, MC12. Russian Soldiers Hold Health Workers and Patients Hostage at Mariupol Hospital, says Human Rights Group 15/03/2022 Kerry Cullinan Mariupol Regional Hospital before it was bombed Health workers, patients and civilians have been held hostage at the Mariupol regional intensive care hospital in Ukraine by Russian troops since Monday morning, according to the Media Initiative for Human Rights (MIHR). Russian soldiers are using the hospital as a base to attack Ukrainian forces, and using the hostages as “human shields” according to MIHR, a respected human rights monitoring group in Ukraine. “We received information from a doctor from the hospital. We can’t name him because of the threat to him. More information will be available after the person is safe,” the MIHR reported on its Facebook page. Pavlo Kyrylenko, head of the Donetsk regional administration, also reported the hostage situation on his Telegram account. Kyrylenko reported that a hostage had told him: “It is impossible to leave the hospital. There is heavy shelling. We sit in the basement. Cars have not been able to drive into the hospital for two days. High-rise buildings are burning around… Russians rushed 400 people from neighbouring houses to our hospital. We can’t leave. “ While the 550-bed tertiary hospital, the biggest in the Donetsk region, has suffered extensive damage, health workers have continued to attend to patients from the basement. “I appeal to international human rights organizations to respond to these vicious violations of the norms and customs of war, to these egregious crimes against humanity,” said Kyrylenko. Humanitarian groups have been appealing for days for a safe passage corridor to and from Mariupol. Some private cars were finally able to leave the city on Monday and Tuesday, the first time in 10 days. But Russian troops that have beseiged the city on all sides have not allowed relief workers to bring in desperately needed medical supplies, food or water. Mariupol. Direct strike of Russian troops at the maternity hospital. People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror? Close the sky right now! Stop the killings! You have power but you seem to be losing humanity. pic.twitter.com/FoaNdbKH5k — Volodymyr Zelenskyy / Володимир Зеленський (@ZelenskyyUa) March 9, 2022 Last week, Russian troops bombed the Mariupol maternity hospital, reportedly killing at least three people. A pregnant woman evacuated from the hospital and her baby later died from their injuries. Mariupol’s deputy mayor, Sergey Orlov, told France24 on Tuesday that at least 2,358 people had been killed during the 11-day siege of the south-eastern city, and he had been fielding desperate calls from people trapped in basements without food or water. While small numbers of people escaped the besieged city on Monday after a series of failed evacuation attempts, as many as 2,500 civilians have died in Mariupol, Ukrainian officials estimate https://t.co/1ksWTFnzaf — CNN International (@cnni) March 15, 2022 ‘Act of unconscionable cruelty’ The World Health Organization (WHO) has verified 31 attacks on health facilities between the start of the Russian invasion on 24 February and 11 March, resulting in 12 deaths and 34 injuries, of which 8 of the injured and 2 of those killed were health workers. My hometown Volnovakha. I was born at this hospital. Now it’s officially denazified and liberated by Russia. pic.twitter.com/nV9lyZX4uQ — Illia Ponomarenko 🇺🇦 (@IAPonomarenko) March 15, 2022 “We call for an immediate cessation of all attacks on health care in Ukraine. These horrific attacks are killing and causing serious injuries to patients and health workers, destroying vital health infrastructure and forcing thousands to forgo accessing health services despite catastrophic needs,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, UNICEF Executive Director Catherine Russell and UNFPA Executive Director Dr Natalia Kanem, in a joint statement on Sunday. “To attack the most vulnerable – babies, children, pregnant women, and those already suffering from illness and disease, and health workers risking their own lives to save lives – is an act of unconscionable cruelty,” they added. “We must be able to safely deliver emergency medical supplies – including those required for obstetric and neonatal care – to health centers, temporary facilities and underground shelters.” Intentionally attacking health facilities is prohibited under international humanitarian law. Unusual position of surrogates Since the start of the war, more than 4,300 Ukrainian women have given birth, and 80,000 others are expected to give birth in the next three months. “Oxygen and medical supplies, including for the management of pregnancy complications, are running dangerously low,” according to the three leaders. “Many pregnant women may need health care, medication and assistance on a daily basis or when complications with pregnancy occur. When medical facilities are not accessible, are destroyed, or health care personnel and medical product are scarce or unavailable, maternal health can be endangered,” according to Eszther Kisomodi and Emma Pitchford, the chief executive and executive editor respectively of the journal, Sexual and Reproductive Health Matters. They also warned that many pregnant women might be in “particular and unusual situations” as Ukraine “is an international surrogacy hub, one of only a handful of countries in the world that legally allows foreigners to enter into surrogacy arrangements”. https://twitter.com/thedalstonyears/status/1501861609446289410 “Being a surrogate is a job in Ukraine for many women, but not one that they can quit, or even put on hold. Very serious questions occur for all parties in this arrangement – for the pregnant women, the newborn child and the intended parents.” The authors also highlight the precarious position of people with disabilities who cannot move easily, LBGTQ people in the face of hostile Russian forces, and people living with HIV in Ukraine, which has the second-highest infection rate in Europe. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Attacks on Health Facilities Are Becoming ‘Part of War Strategy’ in Conflict Zones, Warns WHO 16/03/2022 Kerry Cullinan Attacks on health facilities appear to be part of a deliberate war strategy in Ukraine and other recent conflicts, according to the head of the World Health Organization (WHO) health emergencies programme. The WHO has verified 43 attacks on Ukrainian health facilities since Russia’s invasion on 24 February – and it expects further attacks as over 300 health facilities in conflict areas or under Russian control and a further 600 facilities within 10 kilometres of conflict. But WHO Director-General Dr Tedros Adhanom Ghebreyesus told a media briefing on Wednesday that there had also been 46 attacks on health facilities worldwide since the start of 2022, and people caught in conflicts in Tigray, Yemen and Syria were in extreme need of humanitarian assistance. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme, said that in these conflict zones, attacks on health facilities appeared to be deliberate – in complete violation of international law. “We have never seen this rate of attacks on health care, and health care becoming a target in these situations. It’s becoming part of the strategy and tactics of war and it is entirely unacceptable,” said Ryan. “Under international humanitarian law. conflicting parties are actually instructed to specifically take measures to avoid attacking or inadvertently destroying or hurting health workers or health facilities. They don’t bear responsibility not just to not attack. They actually bear responsibility to ensure that they don’t attack to identify those facilities, to deconflict those facilities and to ensure that they do not, as part of their prosecution of war, attack those facilities,” he added. Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme. Multiple conflicts out of the global eye “Although Ukraine is the focus of the world’s attention, it’s far from the only crisis to which WHO is responding,” said Tedros. “In Yemen, roughly two-thirds of the population – more than 20 million people – are estimated to be in need of health assistance. In Afghanistan, more than half the population is in need, with widespread malnutrition and a surge in measles among many other challenges. “And in Ethiopia, six million people in Tigray have been under blockade by Ethiopian and Eritrean forces for almost 500 days, sealed off from the outside world. There is almost no fuel, no cash and no communications. No food aid has been delivered since the middle of December and 83% of the population is food insecure,” said Tedros, who is from Tigray and added his family and friends were affected by the blockade. Aid to Ukraine – but little for Tigray WHO Director-General Dr Tedros Adhanom Ghebreyesus. The WHO has been able to deliver about 100 metric tonnes of supplies to Ukraine, including oxygen, insulin, surgical supplies, anaesthetics and blood transfusion kits; oxygen generators, electrical generators and defibrillators. However, it had only received $8million of the $57.5 million it needed to support Ukraine. In contrast, however, it had only been able to airlift 33 metric tonnes of medicines and other supplies to Tigray in December – enough for 300,000 people – after being denied access to the territory since last July. “We estimate that 2,200 metric tonnes of emergency health supplies are needed to respond to urgent health needs in Tigray,” said Tedros. Treatment for 46,000 Tigrayan people living with HIV has been abandoned, as has treatment for people with cancer, diabetes, hypertension and tuberculosis. “The situation in Tigray is catastrophic. The blockade on communications, including on journalists being able to report from Tigray, means it remains a forgotten crisis. Out of sight and out of mind,” added Tedros. “Just as we continue to call on Russia to make peace in Ukraine, so we continue to call on Ethiopia and Eritrea to end the blockade, the siege, and allow safe access for humanitarian supplies and workers to save lives,” said Tedros. Global COVID-19 cases rise again Meanwhile, after weeks of global decline COVID-19 cases are on the rise again, especially in parts of Asia. “In the last week, we saw an 8% increase in cases detected with more than 11 million cases reported to WHO despite a significant reduction in testing that’s occurring worldwide,” said WHO COVID-19 lead Dr Maria van Kerkhove. She ascribed the increase to the spread of the Omicron variant – particularly the BA.2 lineage which is “the most transmissible variant we have seen of the SARS Co-V2 virus to date” – in a context where restrictions were being lifted globally. Ryan added that the virus would move from one “pocket of susceptibility” where immunity was waning to another. “The likelihood is that this virus will echo around the world,” said Ryan. “It will pick up pockets of susceptibility and will survive in those pockets for months and months until another pocket of susceptibility opens up,” said Ryan. “This is how viruses work. They establish themselves within a community and they will move quickly to the next community that’s unprotected. If communities around the virus are well protected, the virus can sustain itself, even in small communities. It can stay there, it can rest there, and then wait until susceptibility grows.” Image Credits: Markus Spiske/ Unsplash. WTO Head Welcomes Compromise on IP Waiver for COVID Vaccines – But Activists and Pharma Express Dismay 16/03/2022 Kerry Cullinan WTO members last week in session at the TRIPS Council, which has been debating a controversial proposal for an IP waiver on COVID products for over a year. The World Trade Organization’s (WTO) Director-Genera, Dr Ngozi Okonjo-Iweala has “warmly welcomed” the breakthrough reached this week over a waiver on intellectual property for the production of COVID-19 vaccines. “This is a major step forward and this compromise is the result of many long and difficult hours of negotiations. But we are not there yet. We have more work to do to ensure that we have the support of the entire WTO Membership,” said Okonjo-Iweala, in a statement on Wednesday. The agreement reached between the European Union, India, South Africa and the United States – referred to in some quarters as “the Quad” – still needs to be put to all 164 WTO members, which typically decides by consensus. However, the compromise now has good chances of being approved since EU countries had been the major opponents to the proposal by South Africa and India, submitted in October 2020, to waive IP on COVID-19 vaccines and other pandemic-related health products for the duration of the pandemic. Major concessions South Africa and India had to make major conceessions – both narrowing the waiver to only vaccines, as well as narrowing the list of countries that would be eligible to take advantage of the waiver on patents and other IP. “My team and I have been working hard for the past three months and we are ready to roll up our sleeves again to work together with the TRIPS Council Chair Ambassador Lansana Gberie (Sierra Leone) to bring about a full agreement as quickly as possible. We are grateful to the four Members for the difficult work they have undertaken so far,” said Okonjo-Iweala. The WTO’s Ministerial Council (MC12), postponed from late November to the week of June 13, could potentially approve the waiver move – although the date of that meeting has also been cast into doubt due to the recent outbreak of war in the Ukraine. However, the draft text of the proposed compromise, published by STAT News Tuesday evening, has elicited dismay from both health activists and the pharmaceutical industry – for not going far enough, or for going too far. Restricted to vaccines and certain developing countries In essence, the compromise does three things: Most critically, the new waiver would allow developing countries to not only manufacture, but also to export, generic versions of COVID vaccines that are still under patent protection. Currently, Article 31.f of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement restricts such generic manufacture to health products that are “predominantly for the supply of the domestic market” – leaving low-income countries with no manufacturing base unable to import cheaper generic versions of products from abroad. However, the waiver would be limited to countries that exported less than 10% of the world’s vaccines in 2021. That effectively excludes well-established manufacturers in China, but not India, from waiver eligibility. In contrast to the original Indian-South African proposal, the new IP flexibilities are restricted to COVID vaccines, thus excluding COVID treatments such as new antivirals that are particularly important for countries with low vaccination rates, as well as tests, personal protective equipment (PPE) and other pandemic-related goods. Adam Hodge, spokesperson for US Trade Representative Ambassador Katherine Tai, said late Tuesday that the “compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome” after a “difficult and protracted process”. Since last May @USTradeRep has worked hard to facilitate an outcome on IP that can achieve consensus across the 164 @WTO Members to help end the pandemic. USTR joined informal discussions led by the WTO Secretariat with South Africa, India, and the EU to try & break the deadlock. — USTR Office of Public Affairs (@USTRSpox) March 15, 2022 He and others cautioned that details of a final text were yet to be concluded. “While no agreement on text has been reached and we are in the process of consulting on the outcome, the US will continue to engage with WTO Members as part of our comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible,” added Hodge. The informal discussions, led by the WTO Secretariat, have been trying to break the deadlock between the India-South Africa waiver proposal (supported by the Africa and Least Developed Nations groups and others) and the EU’s counter-proposal. India-South Africa proposal had sought a broad waiver on all vaccines, tests and treatments, while the EU had pushed for technical modifications in the existing TRIPS rules. Medicines access activists and pharma leaders both express dismay Both activists and industry reacted with dismay to news of the proposed agreement. For example, the US-based consumer advocacy group, Public Citizen, called on WTO member states to reject the proposal. “Among its key limitations: the proposal appears to cover only vaccines (not tests and treatments), cover only patents (not other important intellectual property barriers), be limited geographically, and further undermine current WTO flexibilities for compulsory licenses,” according to Melinda St Louis, director of Public Citizen’s Global Trade Watch division. “It would be a mistake for WTO members to prematurely agree to a weakened waiver that provides political cover to the US and EU while not making any meaningful difference in increasing access to vaccines, tests and treatments. No waiver is better than a weak waiver designed solely to save face,” added St Louis. Knowledge Ecology International also expressed disquiet, saying that the waiver may even restrict certain flexibilities that are already allowed by Article 31 of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), regarding a country’s rights to manufacture and export generic versions of drugs or vaccines during a health emergency. “Countries are required to follow Article 31 of the TRIPS [agreement], which of course, is an existing and not a new flexibility, but with ‘clarifications’,” noted KEI’s Director, James Love. However, those “clarifications”, also come with new obligations that could make Article 31 “more restrictive and burdensome”, such as a new obligation for a country to identify all of the patents to which it is applying an IP waiver, and to notify the WTO of its use of the waiver – something not required for the issuance of compulsory licenses in general. On the other hand, the draft agreement makes a first-ever reference to a 2005 WHO/UNDP guidance on payments by developing countries to the original patent-holder, which embraces the concept of “tiered royalties”, based on a country’s ability to pay, and authored by Love himself. Pharma says agreement sends ‘wrong signal’ Meanwhile, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said that “weakening patents now when it is widely acknowledged that there are no longer supply constraints of COVID-19 vaccines, sends the wrong signal”. “When the IP TRIPS Waiver was first proposed in 2020, it was to the wrong solution to the problem of scaling up manufacturing of potential COVID-19 vaccines which at the time had not yet even been authorized,” said the IFPMA. “Now the problem of supply has been addressed thanks to unprecedented collaboration involving companies from industrialized and developing countries, the TRIPS Waiver is not only the wrong solution, it is also an outdated proposal, that has been overtaken by events.” It added that the TRIPS waiver proposal is “political posturing that are at best a distraction, at worse creating uncertainty that can undermine innovation’s ability to respond to the current and future response to pandemics”. “The current proposals should be shelved; and the focus should be directed, to admittedly more difficult actions that will change lives for the better: supporting country readiness, contributing to equitable distribution, and driving innovation,” the IFPMA concluded. The final text of any agreement would first need to be approved by the WTO TRIPS Council, and then go before the MC12 for final approval. The TRIPS Council last met on 9-10 March, but at the time failed to reach a compromise – although some sources noted that the were close to agreement as the “Quad” of India, South Africa, the United States and the EU scrambled to reach a deal. According to a WTO statement on 10 March, the TRIPS Council had agreed to keep the agenda item on the IP waiver open – so as to enable the council to be “reconvened at short notice if substantial progress is made in the high-level talks”. TRIPS Council approval would pave the way for a consensus agreement at the WTO’s Ministerial meeting, MC12. Russian Soldiers Hold Health Workers and Patients Hostage at Mariupol Hospital, says Human Rights Group 15/03/2022 Kerry Cullinan Mariupol Regional Hospital before it was bombed Health workers, patients and civilians have been held hostage at the Mariupol regional intensive care hospital in Ukraine by Russian troops since Monday morning, according to the Media Initiative for Human Rights (MIHR). Russian soldiers are using the hospital as a base to attack Ukrainian forces, and using the hostages as “human shields” according to MIHR, a respected human rights monitoring group in Ukraine. “We received information from a doctor from the hospital. We can’t name him because of the threat to him. More information will be available after the person is safe,” the MIHR reported on its Facebook page. Pavlo Kyrylenko, head of the Donetsk regional administration, also reported the hostage situation on his Telegram account. Kyrylenko reported that a hostage had told him: “It is impossible to leave the hospital. There is heavy shelling. We sit in the basement. Cars have not been able to drive into the hospital for two days. High-rise buildings are burning around… Russians rushed 400 people from neighbouring houses to our hospital. We can’t leave. “ While the 550-bed tertiary hospital, the biggest in the Donetsk region, has suffered extensive damage, health workers have continued to attend to patients from the basement. “I appeal to international human rights organizations to respond to these vicious violations of the norms and customs of war, to these egregious crimes against humanity,” said Kyrylenko. Humanitarian groups have been appealing for days for a safe passage corridor to and from Mariupol. Some private cars were finally able to leave the city on Monday and Tuesday, the first time in 10 days. But Russian troops that have beseiged the city on all sides have not allowed relief workers to bring in desperately needed medical supplies, food or water. Mariupol. Direct strike of Russian troops at the maternity hospital. People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror? Close the sky right now! Stop the killings! You have power but you seem to be losing humanity. pic.twitter.com/FoaNdbKH5k — Volodymyr Zelenskyy / Володимир Зеленський (@ZelenskyyUa) March 9, 2022 Last week, Russian troops bombed the Mariupol maternity hospital, reportedly killing at least three people. A pregnant woman evacuated from the hospital and her baby later died from their injuries. Mariupol’s deputy mayor, Sergey Orlov, told France24 on Tuesday that at least 2,358 people had been killed during the 11-day siege of the south-eastern city, and he had been fielding desperate calls from people trapped in basements without food or water. While small numbers of people escaped the besieged city on Monday after a series of failed evacuation attempts, as many as 2,500 civilians have died in Mariupol, Ukrainian officials estimate https://t.co/1ksWTFnzaf — CNN International (@cnni) March 15, 2022 ‘Act of unconscionable cruelty’ The World Health Organization (WHO) has verified 31 attacks on health facilities between the start of the Russian invasion on 24 February and 11 March, resulting in 12 deaths and 34 injuries, of which 8 of the injured and 2 of those killed were health workers. My hometown Volnovakha. I was born at this hospital. Now it’s officially denazified and liberated by Russia. pic.twitter.com/nV9lyZX4uQ — Illia Ponomarenko 🇺🇦 (@IAPonomarenko) March 15, 2022 “We call for an immediate cessation of all attacks on health care in Ukraine. These horrific attacks are killing and causing serious injuries to patients and health workers, destroying vital health infrastructure and forcing thousands to forgo accessing health services despite catastrophic needs,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, UNICEF Executive Director Catherine Russell and UNFPA Executive Director Dr Natalia Kanem, in a joint statement on Sunday. “To attack the most vulnerable – babies, children, pregnant women, and those already suffering from illness and disease, and health workers risking their own lives to save lives – is an act of unconscionable cruelty,” they added. “We must be able to safely deliver emergency medical supplies – including those required for obstetric and neonatal care – to health centers, temporary facilities and underground shelters.” Intentionally attacking health facilities is prohibited under international humanitarian law. Unusual position of surrogates Since the start of the war, more than 4,300 Ukrainian women have given birth, and 80,000 others are expected to give birth in the next three months. “Oxygen and medical supplies, including for the management of pregnancy complications, are running dangerously low,” according to the three leaders. “Many pregnant women may need health care, medication and assistance on a daily basis or when complications with pregnancy occur. When medical facilities are not accessible, are destroyed, or health care personnel and medical product are scarce or unavailable, maternal health can be endangered,” according to Eszther Kisomodi and Emma Pitchford, the chief executive and executive editor respectively of the journal, Sexual and Reproductive Health Matters. They also warned that many pregnant women might be in “particular and unusual situations” as Ukraine “is an international surrogacy hub, one of only a handful of countries in the world that legally allows foreigners to enter into surrogacy arrangements”. https://twitter.com/thedalstonyears/status/1501861609446289410 “Being a surrogate is a job in Ukraine for many women, but not one that they can quit, or even put on hold. Very serious questions occur for all parties in this arrangement – for the pregnant women, the newborn child and the intended parents.” The authors also highlight the precarious position of people with disabilities who cannot move easily, LBGTQ people in the face of hostile Russian forces, and people living with HIV in Ukraine, which has the second-highest infection rate in Europe. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
WTO Head Welcomes Compromise on IP Waiver for COVID Vaccines – But Activists and Pharma Express Dismay 16/03/2022 Kerry Cullinan WTO members last week in session at the TRIPS Council, which has been debating a controversial proposal for an IP waiver on COVID products for over a year. The World Trade Organization’s (WTO) Director-Genera, Dr Ngozi Okonjo-Iweala has “warmly welcomed” the breakthrough reached this week over a waiver on intellectual property for the production of COVID-19 vaccines. “This is a major step forward and this compromise is the result of many long and difficult hours of negotiations. But we are not there yet. We have more work to do to ensure that we have the support of the entire WTO Membership,” said Okonjo-Iweala, in a statement on Wednesday. The agreement reached between the European Union, India, South Africa and the United States – referred to in some quarters as “the Quad” – still needs to be put to all 164 WTO members, which typically decides by consensus. However, the compromise now has good chances of being approved since EU countries had been the major opponents to the proposal by South Africa and India, submitted in October 2020, to waive IP on COVID-19 vaccines and other pandemic-related health products for the duration of the pandemic. Major concessions South Africa and India had to make major conceessions – both narrowing the waiver to only vaccines, as well as narrowing the list of countries that would be eligible to take advantage of the waiver on patents and other IP. “My team and I have been working hard for the past three months and we are ready to roll up our sleeves again to work together with the TRIPS Council Chair Ambassador Lansana Gberie (Sierra Leone) to bring about a full agreement as quickly as possible. We are grateful to the four Members for the difficult work they have undertaken so far,” said Okonjo-Iweala. The WTO’s Ministerial Council (MC12), postponed from late November to the week of June 13, could potentially approve the waiver move – although the date of that meeting has also been cast into doubt due to the recent outbreak of war in the Ukraine. However, the draft text of the proposed compromise, published by STAT News Tuesday evening, has elicited dismay from both health activists and the pharmaceutical industry – for not going far enough, or for going too far. Restricted to vaccines and certain developing countries In essence, the compromise does three things: Most critically, the new waiver would allow developing countries to not only manufacture, but also to export, generic versions of COVID vaccines that are still under patent protection. Currently, Article 31.f of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement restricts such generic manufacture to health products that are “predominantly for the supply of the domestic market” – leaving low-income countries with no manufacturing base unable to import cheaper generic versions of products from abroad. However, the waiver would be limited to countries that exported less than 10% of the world’s vaccines in 2021. That effectively excludes well-established manufacturers in China, but not India, from waiver eligibility. In contrast to the original Indian-South African proposal, the new IP flexibilities are restricted to COVID vaccines, thus excluding COVID treatments such as new antivirals that are particularly important for countries with low vaccination rates, as well as tests, personal protective equipment (PPE) and other pandemic-related goods. Adam Hodge, spokesperson for US Trade Representative Ambassador Katherine Tai, said late Tuesday that the “compromise outcome that offers the most promising path toward achieving a concrete and meaningful outcome” after a “difficult and protracted process”. Since last May @USTradeRep has worked hard to facilitate an outcome on IP that can achieve consensus across the 164 @WTO Members to help end the pandemic. USTR joined informal discussions led by the WTO Secretariat with South Africa, India, and the EU to try & break the deadlock. — USTR Office of Public Affairs (@USTRSpox) March 15, 2022 He and others cautioned that details of a final text were yet to be concluded. “While no agreement on text has been reached and we are in the process of consulting on the outcome, the US will continue to engage with WTO Members as part of our comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible,” added Hodge. The informal discussions, led by the WTO Secretariat, have been trying to break the deadlock between the India-South Africa waiver proposal (supported by the Africa and Least Developed Nations groups and others) and the EU’s counter-proposal. India-South Africa proposal had sought a broad waiver on all vaccines, tests and treatments, while the EU had pushed for technical modifications in the existing TRIPS rules. Medicines access activists and pharma leaders both express dismay Both activists and industry reacted with dismay to news of the proposed agreement. For example, the US-based consumer advocacy group, Public Citizen, called on WTO member states to reject the proposal. “Among its key limitations: the proposal appears to cover only vaccines (not tests and treatments), cover only patents (not other important intellectual property barriers), be limited geographically, and further undermine current WTO flexibilities for compulsory licenses,” according to Melinda St Louis, director of Public Citizen’s Global Trade Watch division. “It would be a mistake for WTO members to prematurely agree to a weakened waiver that provides political cover to the US and EU while not making any meaningful difference in increasing access to vaccines, tests and treatments. No waiver is better than a weak waiver designed solely to save face,” added St Louis. Knowledge Ecology International also expressed disquiet, saying that the waiver may even restrict certain flexibilities that are already allowed by Article 31 of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), regarding a country’s rights to manufacture and export generic versions of drugs or vaccines during a health emergency. “Countries are required to follow Article 31 of the TRIPS [agreement], which of course, is an existing and not a new flexibility, but with ‘clarifications’,” noted KEI’s Director, James Love. However, those “clarifications”, also come with new obligations that could make Article 31 “more restrictive and burdensome”, such as a new obligation for a country to identify all of the patents to which it is applying an IP waiver, and to notify the WTO of its use of the waiver – something not required for the issuance of compulsory licenses in general. On the other hand, the draft agreement makes a first-ever reference to a 2005 WHO/UNDP guidance on payments by developing countries to the original patent-holder, which embraces the concept of “tiered royalties”, based on a country’s ability to pay, and authored by Love himself. Pharma says agreement sends ‘wrong signal’ Meanwhile, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said that “weakening patents now when it is widely acknowledged that there are no longer supply constraints of COVID-19 vaccines, sends the wrong signal”. “When the IP TRIPS Waiver was first proposed in 2020, it was to the wrong solution to the problem of scaling up manufacturing of potential COVID-19 vaccines which at the time had not yet even been authorized,” said the IFPMA. “Now the problem of supply has been addressed thanks to unprecedented collaboration involving companies from industrialized and developing countries, the TRIPS Waiver is not only the wrong solution, it is also an outdated proposal, that has been overtaken by events.” It added that the TRIPS waiver proposal is “political posturing that are at best a distraction, at worse creating uncertainty that can undermine innovation’s ability to respond to the current and future response to pandemics”. “The current proposals should be shelved; and the focus should be directed, to admittedly more difficult actions that will change lives for the better: supporting country readiness, contributing to equitable distribution, and driving innovation,” the IFPMA concluded. The final text of any agreement would first need to be approved by the WTO TRIPS Council, and then go before the MC12 for final approval. The TRIPS Council last met on 9-10 March, but at the time failed to reach a compromise – although some sources noted that the were close to agreement as the “Quad” of India, South Africa, the United States and the EU scrambled to reach a deal. According to a WTO statement on 10 March, the TRIPS Council had agreed to keep the agenda item on the IP waiver open – so as to enable the council to be “reconvened at short notice if substantial progress is made in the high-level talks”. TRIPS Council approval would pave the way for a consensus agreement at the WTO’s Ministerial meeting, MC12. Russian Soldiers Hold Health Workers and Patients Hostage at Mariupol Hospital, says Human Rights Group 15/03/2022 Kerry Cullinan Mariupol Regional Hospital before it was bombed Health workers, patients and civilians have been held hostage at the Mariupol regional intensive care hospital in Ukraine by Russian troops since Monday morning, according to the Media Initiative for Human Rights (MIHR). Russian soldiers are using the hospital as a base to attack Ukrainian forces, and using the hostages as “human shields” according to MIHR, a respected human rights monitoring group in Ukraine. “We received information from a doctor from the hospital. We can’t name him because of the threat to him. More information will be available after the person is safe,” the MIHR reported on its Facebook page. Pavlo Kyrylenko, head of the Donetsk regional administration, also reported the hostage situation on his Telegram account. Kyrylenko reported that a hostage had told him: “It is impossible to leave the hospital. There is heavy shelling. We sit in the basement. Cars have not been able to drive into the hospital for two days. High-rise buildings are burning around… Russians rushed 400 people from neighbouring houses to our hospital. We can’t leave. “ While the 550-bed tertiary hospital, the biggest in the Donetsk region, has suffered extensive damage, health workers have continued to attend to patients from the basement. “I appeal to international human rights organizations to respond to these vicious violations of the norms and customs of war, to these egregious crimes against humanity,” said Kyrylenko. Humanitarian groups have been appealing for days for a safe passage corridor to and from Mariupol. Some private cars were finally able to leave the city on Monday and Tuesday, the first time in 10 days. But Russian troops that have beseiged the city on all sides have not allowed relief workers to bring in desperately needed medical supplies, food or water. Mariupol. Direct strike of Russian troops at the maternity hospital. People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror? Close the sky right now! Stop the killings! You have power but you seem to be losing humanity. pic.twitter.com/FoaNdbKH5k — Volodymyr Zelenskyy / Володимир Зеленський (@ZelenskyyUa) March 9, 2022 Last week, Russian troops bombed the Mariupol maternity hospital, reportedly killing at least three people. A pregnant woman evacuated from the hospital and her baby later died from their injuries. Mariupol’s deputy mayor, Sergey Orlov, told France24 on Tuesday that at least 2,358 people had been killed during the 11-day siege of the south-eastern city, and he had been fielding desperate calls from people trapped in basements without food or water. While small numbers of people escaped the besieged city on Monday after a series of failed evacuation attempts, as many as 2,500 civilians have died in Mariupol, Ukrainian officials estimate https://t.co/1ksWTFnzaf — CNN International (@cnni) March 15, 2022 ‘Act of unconscionable cruelty’ The World Health Organization (WHO) has verified 31 attacks on health facilities between the start of the Russian invasion on 24 February and 11 March, resulting in 12 deaths and 34 injuries, of which 8 of the injured and 2 of those killed were health workers. My hometown Volnovakha. I was born at this hospital. Now it’s officially denazified and liberated by Russia. pic.twitter.com/nV9lyZX4uQ — Illia Ponomarenko 🇺🇦 (@IAPonomarenko) March 15, 2022 “We call for an immediate cessation of all attacks on health care in Ukraine. These horrific attacks are killing and causing serious injuries to patients and health workers, destroying vital health infrastructure and forcing thousands to forgo accessing health services despite catastrophic needs,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, UNICEF Executive Director Catherine Russell and UNFPA Executive Director Dr Natalia Kanem, in a joint statement on Sunday. “To attack the most vulnerable – babies, children, pregnant women, and those already suffering from illness and disease, and health workers risking their own lives to save lives – is an act of unconscionable cruelty,” they added. “We must be able to safely deliver emergency medical supplies – including those required for obstetric and neonatal care – to health centers, temporary facilities and underground shelters.” Intentionally attacking health facilities is prohibited under international humanitarian law. Unusual position of surrogates Since the start of the war, more than 4,300 Ukrainian women have given birth, and 80,000 others are expected to give birth in the next three months. “Oxygen and medical supplies, including for the management of pregnancy complications, are running dangerously low,” according to the three leaders. “Many pregnant women may need health care, medication and assistance on a daily basis or when complications with pregnancy occur. When medical facilities are not accessible, are destroyed, or health care personnel and medical product are scarce or unavailable, maternal health can be endangered,” according to Eszther Kisomodi and Emma Pitchford, the chief executive and executive editor respectively of the journal, Sexual and Reproductive Health Matters. They also warned that many pregnant women might be in “particular and unusual situations” as Ukraine “is an international surrogacy hub, one of only a handful of countries in the world that legally allows foreigners to enter into surrogacy arrangements”. https://twitter.com/thedalstonyears/status/1501861609446289410 “Being a surrogate is a job in Ukraine for many women, but not one that they can quit, or even put on hold. Very serious questions occur for all parties in this arrangement – for the pregnant women, the newborn child and the intended parents.” The authors also highlight the precarious position of people with disabilities who cannot move easily, LBGTQ people in the face of hostile Russian forces, and people living with HIV in Ukraine, which has the second-highest infection rate in Europe. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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Russian Soldiers Hold Health Workers and Patients Hostage at Mariupol Hospital, says Human Rights Group 15/03/2022 Kerry Cullinan Mariupol Regional Hospital before it was bombed Health workers, patients and civilians have been held hostage at the Mariupol regional intensive care hospital in Ukraine by Russian troops since Monday morning, according to the Media Initiative for Human Rights (MIHR). Russian soldiers are using the hospital as a base to attack Ukrainian forces, and using the hostages as “human shields” according to MIHR, a respected human rights monitoring group in Ukraine. “We received information from a doctor from the hospital. We can’t name him because of the threat to him. More information will be available after the person is safe,” the MIHR reported on its Facebook page. Pavlo Kyrylenko, head of the Donetsk regional administration, also reported the hostage situation on his Telegram account. Kyrylenko reported that a hostage had told him: “It is impossible to leave the hospital. There is heavy shelling. We sit in the basement. Cars have not been able to drive into the hospital for two days. High-rise buildings are burning around… Russians rushed 400 people from neighbouring houses to our hospital. We can’t leave. “ While the 550-bed tertiary hospital, the biggest in the Donetsk region, has suffered extensive damage, health workers have continued to attend to patients from the basement. “I appeal to international human rights organizations to respond to these vicious violations of the norms and customs of war, to these egregious crimes against humanity,” said Kyrylenko. Humanitarian groups have been appealing for days for a safe passage corridor to and from Mariupol. Some private cars were finally able to leave the city on Monday and Tuesday, the first time in 10 days. But Russian troops that have beseiged the city on all sides have not allowed relief workers to bring in desperately needed medical supplies, food or water. Mariupol. Direct strike of Russian troops at the maternity hospital. People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror? Close the sky right now! Stop the killings! You have power but you seem to be losing humanity. pic.twitter.com/FoaNdbKH5k — Volodymyr Zelenskyy / Володимир Зеленський (@ZelenskyyUa) March 9, 2022 Last week, Russian troops bombed the Mariupol maternity hospital, reportedly killing at least three people. A pregnant woman evacuated from the hospital and her baby later died from their injuries. Mariupol’s deputy mayor, Sergey Orlov, told France24 on Tuesday that at least 2,358 people had been killed during the 11-day siege of the south-eastern city, and he had been fielding desperate calls from people trapped in basements without food or water. While small numbers of people escaped the besieged city on Monday after a series of failed evacuation attempts, as many as 2,500 civilians have died in Mariupol, Ukrainian officials estimate https://t.co/1ksWTFnzaf — CNN International (@cnni) March 15, 2022 ‘Act of unconscionable cruelty’ The World Health Organization (WHO) has verified 31 attacks on health facilities between the start of the Russian invasion on 24 February and 11 March, resulting in 12 deaths and 34 injuries, of which 8 of the injured and 2 of those killed were health workers. My hometown Volnovakha. I was born at this hospital. Now it’s officially denazified and liberated by Russia. pic.twitter.com/nV9lyZX4uQ — Illia Ponomarenko 🇺🇦 (@IAPonomarenko) March 15, 2022 “We call for an immediate cessation of all attacks on health care in Ukraine. These horrific attacks are killing and causing serious injuries to patients and health workers, destroying vital health infrastructure and forcing thousands to forgo accessing health services despite catastrophic needs,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, UNICEF Executive Director Catherine Russell and UNFPA Executive Director Dr Natalia Kanem, in a joint statement on Sunday. “To attack the most vulnerable – babies, children, pregnant women, and those already suffering from illness and disease, and health workers risking their own lives to save lives – is an act of unconscionable cruelty,” they added. “We must be able to safely deliver emergency medical supplies – including those required for obstetric and neonatal care – to health centers, temporary facilities and underground shelters.” Intentionally attacking health facilities is prohibited under international humanitarian law. Unusual position of surrogates Since the start of the war, more than 4,300 Ukrainian women have given birth, and 80,000 others are expected to give birth in the next three months. “Oxygen and medical supplies, including for the management of pregnancy complications, are running dangerously low,” according to the three leaders. “Many pregnant women may need health care, medication and assistance on a daily basis or when complications with pregnancy occur. When medical facilities are not accessible, are destroyed, or health care personnel and medical product are scarce or unavailable, maternal health can be endangered,” according to Eszther Kisomodi and Emma Pitchford, the chief executive and executive editor respectively of the journal, Sexual and Reproductive Health Matters. They also warned that many pregnant women might be in “particular and unusual situations” as Ukraine “is an international surrogacy hub, one of only a handful of countries in the world that legally allows foreigners to enter into surrogacy arrangements”. https://twitter.com/thedalstonyears/status/1501861609446289410 “Being a surrogate is a job in Ukraine for many women, but not one that they can quit, or even put on hold. Very serious questions occur for all parties in this arrangement – for the pregnant women, the newborn child and the intended parents.” The authors also highlight the precarious position of people with disabilities who cannot move easily, LBGTQ people in the face of hostile Russian forces, and people living with HIV in Ukraine, which has the second-highest infection rate in Europe. Posts navigation Older postsNewer posts