Pakistan, Afghanistan & Yemen Among Countries With Biggest Vaccine Supply Gaps; US Promises More Jabs for Conflict Zones 11/11/2021 Elaine Ruth Fletcher COVID-19 Ministerial meeting, convened by US Secretary of State Antony Blinken Pakistan and eight other countries, mostly in or around conflict zones, face the largest gaps in vaccine commitments needed to reach a WHO goal of 70% coverage by September 2022. The data is part of a new “COVID Global Tracker” – launched Wednesday during a first-ever meeting of the world’s foreign ministers, convened by US Secretary of State Anthony Blinken. At the meeting, the US also announced that it had brokered a deal to deliver more J&J one-shot vaccines to countries in humanitarian crisis. Pakistan, which has a population of some 221 million people, is short nearly 60 million doses, according to the new data tracker. Data from the other countries, locked in prolonged crises or conflict, reflects the fact that, so far, most of the doses that will be needed have not yet been secured at all. For instance, Afghanistan, with a population of 39 million people, remains short 22 million vaccine doses. Yemen, with a population of 30 million, is short some 18 million doses. And the Democratic Republic of Korea (PRK), with a population of some 26 million people, is some 16 million doses. The gaps between demand and supplies available to the countries with the biggest long-term needs would be narrowed if one-shot J&J shots are deployed. Syria with a population of 17.5 million people is short 11 million doses, and Haiti (HTI), with 11.4 million people, is short some 7 million doses. Other countries on the list include Papua New Guinea (pop: 9 m), Nicaragua (pop: 6.6 m) and Laos (pop: 7.3 m). Top 9 Countries with Largest Gaps to Reach 70% Coverage (millions of doses) Data published on the “COVID Global Tracker, highlights in vivid detail the shortfall in vaccine access that low- and middle-income countries face, including a large swathe of Africa – and which is likely to persist throughout 2022. First-ever meeting of foreign ministers on COVID pandemic The meeting marked the first time that the US had convened foreign ministers to discuss responses to the COVID-19 pandemic since it began in February of 2020. Ït brought together some 40 ministers, including China’s, said Gayle Smith, State Department coordinator for global COVID-19 response in a press readout following the meeting. Noting that the pandemic is not just a health crisis but a security, economic and humanitarian crisis, Blinken said, “we need foreign ministers to step up and lead as well.” In press statements after the meeting, Blinken also called for expanded government and private sector collaborations to expand vaccine manufacturing, unlock supply logjams, and support expanded vaccination efforts in low- and middle-income countries. Only 13% of COVAX contracted doses delivered so far – ministerial meeting fails to yield more concrete commitments on delivery But the meeting did not translate into any immediate commitment to close the gap in dose deliveries to low- and middle WHO Director General Dr Tedros Adhanom Ghebreyesus, asked ministers to immediately set up a working group to deliver the estimated 514-680 million vaccine doses that would be needed needed to ensure 40 percent of each country’s population is vaccinated by year’s end. Some some 74 countries, mostly in sub-Saharan Africa, remain off track for meeting that 40% coverage goal, according to the data on the newly-released COVID19 Global Tracker. Sixty of those countries are among the 91 low- and middle-income countries that are primarily depending on COVAX, or the African Vaccine Acquisition Task Team (AVATT), for deliveries. The remainder are in fact upper-middle income countries that have fallen through the cracks. Expected Effective Vaccine Supply at End-2021 (% of Total Population): Most of sub-saharan Africa, and parts of Asia, could, at best, only reach 10-20% coverage – as compared to the 40% WHO goal. Only 13% of doses contracted by COVAX, and 6% of doses contracted by AVATT have actually been made available for delivery so far by manufacturers, the COVID Global Tracker also shows. That translates into a whopping 3.45 billion COVAX doses still missing from supplies, according to the Global COVID Tracker. Civil Society groups issue new call to prioritze LMICs in new dose deliveries as well as donations Along with WHO’s call on rich countries to release more dose donations, civil society groups called upon the ministers to let low- and middle-income countries jump the line – and receive first priority for forthcoming vaccine deliveries. The ministers should “agree to share all doses between those needed for domestic demand, as soon as they come off the production line,” in coordination with COVAX and AVATT, stated the open letter signed by nearly 40 civil society groups, including the Rockefeller and Open Societies Foundations: “HICs must publicly commit to send their expected deliveries straight to COVAX and regional mechanisms in Q4 2021 and organize this without delay with pharmaceutical and delivery companies. Ministers must use all routes available, including donations and ‘queue swaps’, to deliver doses to LMICs quickly.” But far those appeals have failed to get a response – including at the recent meeting. G-20 countries also remain far off course in delivering doses against promised donations. Insufficient progress on delivering pledged doses to COVAX – across most high-income countries Waiving Indemnity – eases vaccine delivery to crises regions On a brighter note, the US deal with J&J should ease the flow of those one-shot vaccines, including US vaccine donations, to a range of states in crises. The arrangement involves the company’s waiving of liability requirements that vaccine manufacturers typically demand of countries before vaccine acquisition deals are signed. “I’m pleased to share that the United States has helped broker a deal between J&J and COVAX to facilitate the first delivery of J&J vaccines to people living in conflict zones and other humanitarian settings,” Blinken said at the meeting. “We’re eager for people in these difficult circumstances to get protection against COVID-19 as soon as possible. We know the urgency of this fight,” he added. “We’ve got to be relentless because this pandemic is relentless. And we have to be coordinated, united, because that’s what a global health emergency like this requires.” Only a handful of other Chinese firms have also waived such indemnity requirements, including: Sinopharm and Sinovac, which have WHO-approved jabs on the market, as well as the biotech firm Clover, whose vaccine R&D was has been supported by the Oslo-based Coalition for Epidemic Preparedness (CEPI), followed by a recent IPO that raised $240 million on the Hong Kong stock exchange just last week. While still undergoing WHO review, Clover has already signed a deal with Gavi, the Vaccine Alliance, to supply its vaccine to COVAX following successful results of a Phase 2/3, multi-country trial of 30,000 people. In that trial, Clover announced that it’s vaccine had been 84% efficacious against moderate-to-severe COVID, and 100% efficacious against severe COVID. Image Credits: US Department of State, https://covid19globaltracker.org/, https://covid19globaltracker.org/. New Report Predicts 2.4°C Warming as COP26 Negotiators Race to Reach Climate Agreement – ‘Health’ Missing from Draft 10/11/2021 Kerry Cullinan COP26 president Alok Sharma A draft agreement released by UN Climate on Wednesday “calls upon parties to accelerate the phasing out of coal and subsidies for fossil fuels” – as countries work toward reaching consensus by the time the Glasgow Climate Conference (COP26) ends on Friday. The word ‘health’ also was noticeably absent from the draft text, reflecting the continued failure of the global community to recognise and address the intrinsic linkages between planetary and human well-being. Despite a recent spate of promises, including new pledges by the US and China, limiting global warming to 1.5° Celsius remains well out of reach. Even if all commitments are met, the world would still see 2.4°C warming by the end of the century, experts now predict. That was the conclusion of the non-profit Climate Action Tracker, which added up the most recent country pledges – or Nationally Determined Contributions (NDCs) – for CO2 reductions – translating those into forecasts for expected temperature rise. Target shortfalls reported by Climate Action Tracker. Earlier calculations had estimated a 2.7°C temperature rise – showing slight gains in the slow race to carbon neutrality. Dr Stephen Cornelius, the World Wildlife Fund’s chief advisor on climate change, described the country pledges as “woefully inadequate”. “COP26 has gotten further than Paris, but we are nowhere near the 1.5°C needed to avoid the worst impact of climate change,” Cornelius told a media briefing on Wednesday. However, he welcomed the draft’s recognition of the importance of science, including reference to the “code red” warning contained in a recent report issued by the Intergovernmental Panel on Climate Change (IPCC) on the urgency of climate action. ‘Wreckers’ like Saudia Arabia and Australia will try to weaken text Greenpeace International Executive Director Jennifer Morgan described the draft declaration as “a polite request that countries maybe, possibly, do more next year”. “We’ve just had a landmark study showing we’re heading for 2.4°C of warming,” said Morgan. “The job of this conference was always to get that number down to 1.5°C, but with this text, world leaders are punting it to next year.” #COP26: The new draft final decision text published today is not a plan to solve the climate crisis, it’s an agreement that we’ll all cross our fingers and hope for the best. It’s a polite request that countries maybe, possibly, do more next year. That’s not good enough. (1/2) — Jennifer Morgan (@climatemorgan) November 10, 2021 Greenpeace wants an agreement that is much stronger on finance for countries to mitigate and adapt to climate change. It also wants a commitment from countries to report annually – instead of every five years – on “new and better” plans until the world is able to reduce the global warming trajectory to the 1.5°C goal. While the language calling for an accelerated phase out fossil fuel subsidies, estimated to exceed $5 trillion annually, is seen as a signal of progress, there is no timeline for that to take place. And Morgan predicted that “wreckers like the Saudi and Australian governments” would try to delete the call for an accelerated phaseout of coal and fossil fuel subsidies from the draft. UK Green MP Caroline Lucas also condemned the draft, saying that it “utterly fails to rise to the moment” by failing to phase out all fossil fuels not just coal. Today’s draft #COP26 draft decision utterly fails to rise to the moment. The time for expressing “alarm & concern” is over – we need urgent action *now* & a pledge to phase out *all* fossil fuels, not just coal, which accounts for less than half the emissions problem. — Caroline Lucas (@CarolineLucas) November 10, 2021 COP26 delegates ignore warnings that fossil fuel subsidies are dangerous to health Fossil fuel subsidies have been repeatedly decried by the World Health Organization and other health experts at a series of health-focused COP26 events as particularly pernicious. Such subsidies, WHO points out, fuel dirty energy and transport sources – leading to air pollution emissions that kill an estimated 7 million people a year – while also discouraging investments in cleaner solutions that would be more cost-effective for societies overall. But the draft final COP statement had nary a word about health – or the climate-air pollution nexus plaguing many developing cities, particularly in South-East Asia. “Nearly half a billion will suffer severe health harm from north India’s air pollution even as COP26 offers up unambitious targets to a world at the brink of extinction,” stated the Indian NGO Care for Air. Nearly half a billion will suffer severe health harm from north #India’s #airpollution even as #COP26 offers up unambitious targets to a world at d brink of #extinction from#carbonemissions @HealthPolicyW @DrMariaNeira @UNEP @WHO @Jane_Burston @EPIC_India @1kenlee @dpcarrington — Care for Air (@CareForAirIndia) November 10, 2021 Paradoxically, COP will be concluding just as northern India’s seasonal air pollution emergency begins – a situation seen every autumn when smoke from crop stubble-burning in rural areas drifts toward Delhi, where it combines with a potent mix of fumes from construction, traffic, waste burning, and firecrackers celebrating the Hindu Diwali festival. Grand promises by politicians last year to devise more sustainable alternatives for farmers – such as composting or machine threshing of crop stubble – to have so far failed to materialize. ‘Massive credibility gap’, absence of clear targets for fossil fuel phase-out In Glasgow, politicians seemed anxious to avoid making the potent linkages between climate change and millions of deaths a year from air pollution. Language in the draft agreement remained general and non-specific around critical points, such as setting a target or timeline for actually phasing out fossil fuels. The draft agreement merely “invites parties to consider further opportunities to reduce non-carbon dioxide greenhouse gas emissions”. The statement does, however, go further than previous COP declarations in suggesting that a more holistic approach to the climate crisis is needed, emphasising the “critical importance of nature-based solutions and ecosystem-based approaches, including protecting and restoring forests, in reducing emissions, enhancing removals and protecting biodiversity”. Even so, “at the midpoint of Glasgow, it is clear there is a massive credibility, action and commitment gap that casts a long and dark shadow of doubt over the net zero goals put forward by more than 140 countries, covering 90% of global emissions”, Climate Action Tracker’s briefing document observed. The country targets for 2030 remain “totally inadequate”, added the report, estimating that they “put us on track for a 2.4°C temperature increase by the end of the century”. Another significant unresolved issue: LMIC financing COP26 President Alok Sharma confirmed at a plenary on Wednesday that while “some significant issues remain unresolved”, he expected “near-final” texts from the various negotiating groups by Thursday morning and a consensus document for adoption by the close of the summit on Friday. Aside from the inadequate emission targets, other sticking points concern financing, including agreement on finance for countries’ claims of climate change-related loss and damage – most of which are likely to be filed by low- and middle income countries. UK lead climate negotiator Archie Young told the plenary that more work also needs to be done on the “significant finance agenda and the $100-billion goal” – the annual finance target set by the Paris Agreement to be available by the end of 2021 to assist LMIC countries to mitigate and adapt to climate change. The draft appeals to “the private sector, multilateral development banks and other financial institutions to enhance finance mobilization in order to deliver the scale of resources needed to achieve climate plans, particularly for adaptation”. Glasgow flooded with fossil fuel lobbyists While the global business and finance community is said to have an unprecedented presence at COP26 – the largest contingent at the entire conference – is in fact the fossil fuel industry, an analysis of participants found. Some 503 fossil fuel lobbyists are registered at Glasgow, according to the analysis by the civil society groups, Corporate Europe Observatory (CEO) and GlobalWitness.org. The report “Glasgow Calls Out Polluters” found that if the fossil fuel lobby were a country delegation at COP it would be the largest with 503 delegates – two dozen more than the largest country delegation. In addition, the report found that: Over 100 fossil fuel companies are represented at COP with 30 trade associations and membership organisations also present; Fossil fuel lobbyiests are members of 27 official country delegations, including Canada, Russia and Brazil. Fossil fuel lobbyists dwarf the UNFCCC’s official indigenous constituency by around two to one. The fossil fuel lobby at COP is larger than the combined total of the eight delegations from the countries worst affected by climate change in the last two decades – Puerto Rico, Myanmar, Haiti, Philippines, Mozambique, Bahamas, Bangladesh, Pakistan. Image Credits: Climate Action Tracker., Climate Action Tracker. Fifty Countries Commit to ‘greening’ their healthcare systems at COP26 09/11/2021 Kerry Cullinan Solar panels provide electricity to Mulalika Health Clinic in Zambia. Fifty countries have committed to building sustainable, low-carbon and climate-resilient healthcare systems, and 14 of these have set net-zero carbon emission target dates from as early as 2030. This emerged from a health and climate change session at COP26, the United Nations climate conference in Glasgow, that was co-hosted by the World Health Organization (WHO). “As part of a green and resilient recovery from COVID-19, we need to recognise the role of health systems as emitters accounting for 4% to 5% of global emissions,” said Dr Rachel Levine, US Assistant Secretary in the Department of Health and Human Services. If the global health care sector were a country, it would be the fifth-largest greenhouse gas emitter on the planet, according to Health care’s climate footprint, a report produced by Health Care Without Harm. “These emissions are predicted to increase as health systems develop, and demographic changes lead to increasing healthcare demand,” said Levine, adding that the countries that had committed to building low carbon health systems were responsible for about one-third of all health sector emissions globally. The US has committed to decarbonizing the nation’s health systems by reducing greenhouse gas emissions in the federal health system, as well as the private sector via “incentives, guidance, technical assistance and regulatory approaches and partnerships”, Levine added. “The United States action on health system decarbonization is influential and critical. The US accounts for approximately 25% of the world’s health sector greenhouse gas emissions. This commitment to reducing greenhouse gases will also result in decreasing the negative health impacts of air pollution, such as premature death, heart disease, stroke, and more,” said Levine. Breaking: #COP26, over 50 countries have committed to decarbonize their #health systems a first ever COP presidency event on climate & health.Health sector is stepping up to decarbonize & calling global leaders to do the same!#ClimateEmergency #ClimatePrescription @HCWHGlobal pic.twitter.com/iwPhsdUJxW — Global Climate and Health Alliance (@GCHAlliance) November 9, 2021 Josh Karliner, International Director of Program and Strategy at Health Care Without Harm, said that “there is a growing global movement of hospitals and health systems” that were already reducing their carbon emissions. “There are more than 54 institutions in 21 countries representing more than 14,000 hospitals and health centres committed to race to zero,” said Karliner. “This is from Newcastle to New York. It’s from Sao Paulo to South Africa. It’s from Kerala to California.” Karliner explained: “We’re seeing hospitals and health systems taking action by investing in renewable energy by investing in zero-emission buildings and transport; by substituting anaesthetic gases with more sustainable alternatives; by implementing sustainable procurement programmes to purchase sustainably produced food, energy-efficient medical devices and lower carbon pharmaceuticals.” However, ‘greening’ health systems is a massive, expensive undertaking that requires many fundamental changes covering architecture, waste disposal, energy, and water. A flash flood in Fiji in 2018 Small island states struggle to make health services climate-resilient Dr Satyendra Prasad, Fiji’s permanent representative to the UN, told the meeting that his country struggled to keep health services running when faced with superstorms and other adverse weather events. “It is quite tragic when your doctors and nurses are being evacuated when they should be providing frontline services to people who have been injured and who need care,” said Prasad. “This conundrum is very tough, and it is a conundrum that exists for so many countries,” said Prasad, adding that Fiji is in the process of relocating health services to higher ground and equipping facilities with renewable energy to enable them to remain operational after major cyclones of flooding. “We losing fewer lives to extreme weather catastrophes. We are losing more lives to waterborne diseases and all the diseases that come following a major catastrophe such as flooding, and cyclone,” he added. Similarly, the Maldives has seen the emergence of vector-borne tropical diseases such as Dengue, which it didn’t use to have, said Aminath Shauna, Minister of Environment, Climate Change and Technology in the Maldives. “The Maldives is one of the most vulnerable island nations to climate change. We are experiencing things that we thought would happen towards the end of the century,” said Shauna. “Our coral reefs are dying. We are running out of fresh water. Our islands are eroding, and our islands are getting more frequently flooded, which poses a significant challenge to our public health system,” she added. To mitigate these risks, the Maldives has integrated climate risks into health policy, developed climate-sensitive disease programmes and is promoting climate-resilient healthcare facilities that are able to withstand climate events. It is also working to ensure that its essential services such as water, sanitation, waste management and electricity can still function during extreme weather events. “The Maldives health sector is also committed to initiating the greening of the health sector by adopting environment-friendly technologies and using energy-efficient services,” said Shauna. Finances for adaptation However, finances to make these changes are a challenge for countries like Fiji and the Maldives. Lack of finance has been a recurrent theme at COP26, with smaller countries with small carbon footprints appealing for reparations from large polluting countries to assist them to mitigate climate change. Former UK prime minister Gordon Brown and WHO Ambassador for Global Health Financing told the meeting that “you cannot cut investment in health at the expense of climate change – and you cannot cut investment in climate finance at the expense of health”. “We really have to recognise that we’re dealing with global public goods – the control of infectious diseases, a clean environment, clean air and a clean environment,” said Brown. “And we need to have a system of global burden-sharing where the richest countries that are responsible for the historic emissions and have the wealth and the capacity to pay, make good the funding that is necessary for mitigation and adaptation, and that includes the adaptation of healthcare systems, particularly in the poorest parts of the world,” said Brown. Despite the global commitment made at Paris COP to ensure $100 billion a year in financing to mitigate climate change by the end of this year, it looks like this target will only be reached in 2023. However, Brown stressed that if this target was not reached, it would deprive developing countries “of the opportunity not only to build coastal defences and renewable industries, but to build the healthcare systems that are necessary for resistance to droughts and famine, and also to pollution in the air”. .@WHO strongly welcomes commitments made at #COP26 by some countries to build health systems resilient to the impacts of the #ClimateCrisis, incl. extreme weather events, the increasing burden of diseases related to #airpollution and our warming planet. https://t.co/lDSceMsWlg pic.twitter.com/8dhOmL8QXM — Tedros Adhanom Ghebreyesus (@DrTedros) November 9, 2021 Addressing the meeting via a recorded message, WHO Director-General Dr Tedros Adhanom Ghebreyesus said that the changes the world needed to make to energy, transport and food systems to meet the Paris climate goals “would bring massive health gains”. He added that the WHO is committed to working with the countries that had committed to building greener health systems “for a healthier and more sustainable future”. Image Credits: UNDP/Karin Schermbrucker for Slingshot , World Meterological Organisation. Health Impacts of Climate Change Grab Eyeballs at COP26, But Lack of Finance Continues to be Major Issue 09/11/2021 Disha Shetty WHO Director-General Dr Tedros receiving an open letter about climate change, signed by health professionals from around the world and organized by Doctors for XR. GLASGOW – Conversations on the health impacts of the climate crisis have grown this year at COP26 – the United Nation’s annual climate conference, now in its 26th year. Experts hope that this increase in conversation will lead to greater awareness about the health crisis exacerbated by the climate crisis and lead to concrete action in the months and years ahead. Around 85% of countries now have a designated focal point for health and climate change in their ministries of health, according to the 2021 World Health Organization (WHO) health and climate change global survey report released on Monday. But countries report that a lack of funding, impact of COVID-19, and insufficient resource capacity are major barriers to progress. Many countries are unsupported and unprepared to deal with the health impacts of climate change, according to the survey. “We are here at COP26 to urge the world to better support countries in need, and to ensure that together we do a better job of protecting people from the biggest threat to human health we face today,” said Dr Maria Neira, WHO Director of Environment, Climate Change and Health. At the sidelines of the climate negotiations, the WHO held a day-long conference over the weekend focussed on the climate and health that was attended by high-level delegates. “We are used to talking about climate as an environmental challenge, an economic challenge, an equity challenge. But it is also one of the most urgent health challenges facing us all today,” said Julia Gillard, former Prime Minister of Australia and Chair of Wellcome Trust. The conference sought to highlight that while climate change affects health, the mitigation strategies will also automatically translate into health gains. “Health must become the beating heart of climate action”, said Jeni Miller, executive director of the Global Climate and Health Alliance. “Political leaders must prioritise health and social equity, emission reduction and impact mitigation over politics, profit and unproven technological fixes. The decisions made during COP26 will define the health and wellbeing of people all over the world for decades to come”. Dr. Maria Neira, Director of WHO Environment, Climate Change and Health Highlighting the health gains of clean air In the first week of the COP26 negotiations, WHO also co-hosted a panel discussion on both the health and climate gains of clean air that this reporter helped moderate. Given that air pollution alone kills around seven million people worldwide every year, any progress on this would save millions of lives annually. The event also came at a time when air pollution in India’s capital, Delhi, had reached lethal levels following last week’s celebration of the festival Diwali, during which people set off fire crackers. The densely populated Indo-Gangetic plain where Delhi is, is one of the world’s most polluted regions, and emerging research suggests the source of air pollution is local. Dr Neira said that the time for conversations was over, the evidence on air pollution is clear and it is time now to act. As many of the pollutants that cause air pollution also lead to a greenhouse effect, the WHO has made efforts to highlight the dual climate and health gains of improving air quality that disproportionately affects vulnerable groups like children and the elderly. Developing countries are pushing for climate finance and technology transfer at COP so that they have the support they need to clean their air but much of this also needs to happen at sub-national levels, especially at city-level, that will also require local action, highlighted Ani Dasgupta, President and CEO of World Resources Institute (WRI). Health not a part of text of negotiations It was clear although that while health is a part of the growing conversation, it is far from figuring in the main climate negotiations. A former negotiator elaborated that, given how bitter and exhausting climate negotiations are, adding health to the text might not be practical and that any reduction in global carbon emissions will automatically translate into health gains. At this year’s COP there is also a push to hold the rich countries accountable for the loss and damage being caused by the climate crisis in vulnerable nations. Public health crisis, even though directly caused or exacerbated by extreme climate events, aren’t part of these negotiations either. “I don’t see it coming up very directly into the loss and damage negotiations here because the negotiations are more about the overarching structures, not necessarily on a very particular theme,” said Sven Harmeling, the International Climate Policy Lead, from CARE and CAN Europe. He did add that it does factor in how many of the developing countries think about the damages being caused. WHO’s latest survey backs his view. It found that virtually all (94%) countries have incorporated health considerations in their nationally determined contributions (NDCs) to the Paris Agreement, voluntary pledges by the government to reduce their carbon emissions. Emissions from coal-burning power stations are causing air pollution that is affecting millions of people worldwide. Highlighting emissions from healthcare and silos Among the conversations at COP26 that centred on healthcare was also how to get the healthcare sector to reduce its own emissions. A 2019 report from Healthcare Without Harm based on 2014 data on carbon emissions suggests that globally 4.4% of carbon emissions are from the healthcare sector itself. The US health sector had the largest greenhouse gas emissions. Andrea Epstein, climate programme manager for Latin America at Healthcare Without Harm said that number is probably higher now that despite the region being a part of the developing world, there is a growing interest in decarbonizing the health systems. “The problem is of course the means of implementation. Not just the financing and the technology but also having the capacity for that. So while it is a challenge, the interest is there.” Members of the civil society organisations present at COP highlighted the silos that continued to exist in conversations around health, climate and food – all of which affect each other but are handled by different organisations. Disha Shetty is reporting from COP26 as a part of the 2021 Climate Change Media Partnership, a journalism fellowship organized by Internews’ Earth Journalism Network and the Stanley Center for Peace and Security. Follow her on Twitter @dishashetty20 Image Credits: WHO/Chris Black, Planetary Health Eastern Africa Hub. Pandemic Treaty Offers Opportunity to Repair Fault Lines in COVID-19 Response – and Address Equity 09/11/2021 Kerry Cullinan A nurse takes the temperature of a child suspected of COVID-19 symptoms in a Lebanese public health centre. An international pandemic treaty based on equity could be the antidote to current weaknesses and imbalances in the global response to COVID-19, according to a group of influential authors in a Lancet paper published on Tuesday. A number of the authors are associated with The Independent Panel for Pandemic Preparedness and Response chaired by Helen Clark and Ellen Sirleaf Johnson, which was set up to assess the World Health Organization’s (WHO) response to COVID-19. Based on a timeline developed by the panel that lays out the global COVID-19 response, the authors conclude that the International Health Regulations (IHR) are too weak, and the required country actions are too slow, to protect the world against pandemics. Revised after the 2005 Severe Acute Respiratory Syndrome (SARS) outbreak, the IHR focus on balancing disease notification and health risks with international trade and travel considerations. They specify when and how Member States should notify WHO of a local disease outbreak, and what actions WHO and States should take after that notification. The IHR are currently the only legally binding international instrument governing countries’ obligations to report and respond to pathogens that could result in cross-border disease outbreaks and potential public health emergencies. In their review, the authors identified a number of significant IHR weaknesses, including: constraints on WHO reporting publicly about national events with pandemic potential; the need for greater specificity on the information that countries need to share with WHO; and a streamlined process to facilitate WHO verification of events within 24 hours of the first signals of an outbreak being received. Special World Health Assembly The article comes a few weeks before global leaders meet at a World Health Assembly special session (29 November – 1 December) to consider adopting an “instrument or treaty” to address pandemic preparedness and response. “It’s clear: if a new, fast-spreading pathogen were to emerge next month, the current IHR regime would not protect people and trade as intended,” said Dr Sudhvir Singh, lead author on the paper and an advisor to the Independent Panel. “We suggest change to the IHR and a new treaty or another instrument that would result in more information shared faster, WHO able to investigate rapidly, all countries moving immediately to assess risk; and tools, like tests and vaccines, available to all who need them.” Georgetown University’s Dr Alexandra Phelan added that “COVID-19 has shown that the existing obligations under the IHR are insufficient for our interdependent and digital world.” “Our analysis demonstrates that collectively, countries urgently need to update our international system to respond to the potential rapid spread of a high impact respiratory pathogen,” said Phelan. “We have concrete suggestions for ways in which the IHR may be revised or amended, as well as the approach and issues that must be covered in any new legal framework, like a pandemic treaty.” Four reasons for a pandemic treaty The authors advance four reasons why a pandemic treaty “presents the opportunity to enact comprehensive reform in pandemic preparedness and response”. “First, a pandemic treaty centred on the principle of equity would be an important signal of international commitment to guard against the entrenchment of global division and injustice.” A pandemic treaty offers an opportunity to “develop and instil norms of equity, justice, and global public goods of pandemic preparedness and response”, they argue. “Second, a pandemic treaty could provide high-level complementarity to the IHR and any potential post-pandemic reforms and proactive multidisciplinary approaches to zoonotic risk,” they argue. Their third argument is that a treaty establishes greater accountability, outbreak support, and global access to vital public health information. Finally, a pandemic treaty could provide the opportunity to develop “a solid evidence base for non-pharmaceutical interventions” that might prevent the next outbreak from becoming a pandemic. “The upcoming Special Session of the World Health Assembly is a critical opportunity for Member States to move ahead with strengthening the IHR and to agree on a process for negotiating a pandemic treaty. We must not lose this opportunity to protect global public health and future generations,” said Phelan. At a recent event hosted by G2H2, civil society organisations expressed fear that a pandemic treaty was a distraction from the TRIPS waiver. But Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver. Kümmel added that amending the IHR also would take time to negotiate. And a key question here is: “would they be a game-changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” Image Credits: UNICEF . Obama Critical of China and Russia’s ‘Dangerous Lack of Urgency’ in Climate Change at COP26 08/11/2021 Raisa Santos Former US President Barack Obama speaking at COP26 Former US President Barack Obama openly criticized two of the world’s largest CO2 emitting countries – Russia and China, for their “dangerous lack of urgency” in discussing the pressing matters of climate change this past week during COP26. Both Chinese President Xi Jinping and Russian President Vladimir Putin failed to make an appearance with other global leaders at the 26th United Nations Climate Change Conference in Glasgow, which Obama found to be “particularly discouraging,” as he addressed a room of climate experts at the event on Monday. “We need advanced economies like the US and Europe leading on [the issue of climate change]. But we also need China and India, we need Russia, just as we need Indonesia and South Africa and Brazil leading on this issue. We can’t afford anybody to be on the sidelines.” Obama noted that while there has been some progress made in the six years since the Paris Agreement, the legally binding international treaty on climate change, the world still falls short of their commitment to limit global warming to well below 1.5 C. “Here in Glasgow we see the promise of further progress. What is also true is that collectively and individually, we are still falling short. We have not done nearly enough to address this crisis.” “We are going to have to do more and whether that happens or not to a large degree is going to depend on you,” said Obama, calling for collective action from young people and politicians alike to take climate change seriously. Twenty countries pledge to end public finance of international fossil fuel development Although most nations have failed to be ambitious in their climate goals in the past week of COP26, said Obama, significant accomplishments and hard-won commitments have been made during the climate conference. One such commitment was for high-income countries to help low- and middle-income countries move away from fossil fuels. Back in September, US President Joe Biden told the UN General Assembly that the US would provide more than $11 billion in climate aid annually by 2024 to developing nations vulnerable to extreme weather and rising temperatures. In addition, the US and 20 other countries have pledged to stop publicly financing international fossil fuel development, with limited exceptions. “We will end new public direct support for the international unabated fossil fuel energy sector by the end of 2022,” the declaration read. The 20 countries that signed the pledge include Denmark, Italy, Finland, Costa Rica, Ethiopia, Gambia, New Zealand and the Marshall Islands, plus five development institutions including the European Investment Bank and the East African Development Bank. This deal does go further than a pledge made earlier in the year by the G20 to end international financing of coal-based power generation outside their own countries. However, this declaration does not include major Asian countries responsible for financing a majority of overseas fossil fuel projects. Climate change cannot be a partisan issue While collective action in fighting climate change requires international cooperation, Obama noted the geopolitical tensions that have arisen as a result of the pandemic, but called for the world to step up despite these tensions. “Climate change can’t be seen anywhere in the world as just an opportunity to score political points.” “Saving the planet isn’t a partisan issue. Nature, physics, science, do not care about party affiliation,” he added. Climate change, in the US particularly, has become a partisan issue, causing what Obama referred to as a “lack of leadership on America’s part” and the “open hostility towards climate science at the very top of the [US] federal government” that resulted from former President Donald Trump’s four years in office. Obama also pointed out that the lack of a stable congressional majority has prevented him and current President Joe Biden from taking an even stronger stance on climate change. However, Obama remain sconfident that Biden’s Build Back Better Framework, which would set the US on course to meet its climate goals, would be passed in coming weeks. The legislation, once approved by the US Congress, would devote at least US $1.7 trillion dollars to reduce greenhouse gas emissions by over a billion metric tons by the end of 2030. Young people have more at stake in the fight against climate change Greta Thunberg addresses climate strikers at Civic Center Park in Denver, Colorado. Thunberg is one climate activist Obama praised for inspiring millions in the fight against climate change. Though Obama noted that at times, he was “doubtful that humanity can get its act together before it’s too late”, this cynicism was countered by the prevailing efforts of young climate activists around the world. Addressing all the young people, who Obama said, had “more stake in this fight than anybody else,” he said: “I want you to stay angry. I want you to stay frustrated. Channel that anger, harness that frustration.” “Because that’s what’s required to meet this challenge. Solving a problem this big and this important has never happened all at once.” Image Credits: COP26, Andy Bosselman, Streetsblog Denver/Flickr. Children’s Health Hit Hardest by Climate Change – but Cleaner Air, Greener Cities and Healthier Foods Can Create Cascade of Benefits 07/11/2021 Elaine Ruth Fletcher Rosamund Kissi-Debrah, mother of 11-year Ella, whose 2013 death from severe asthma was the first to be recognized by a court as caused by air pollution. Greening cities, investing in urban bike lanes rather than new roads, and making plant-based foods cheaper and easier to access than ultra-processed foods. This is a doctor’s prescription for a healthier planet. As climate negotiators at Glasgow’s COP26 conference remain locked in debate over the big-picture ambition of targets for global CO2 emissions reductions, and how to finance them, health advocates are trying to raise the profile of climate policies that would yield far-reaching knock-on benefits to the health of almost everyone on earth – but particularly for children, women and people living in some the poorest nations of the world. “We have sacrificed children all around the world to air pollution,” said Rosamund Kissi-Debrah, noting that some 500,000 children a year die from air pollution. Kissi-Debrah was speaking at the COP26 “Triple Win Scenario” event on Friday, co-sponsored by the WHO and the World Resources Institute. Kissi-Debrah’s 11-year-old girl daughter, Ella, was one of those victims. But her death from severe asthma in 2013 set a precedent: it was the first to be recognised by a court anywhere in the world as air-pollution induced. "We have sacrificed children all around the world to #airpollution" – caused by the same sources of #climatechange: Rosamund Kissi-Debrah, mother of 9-year-old Ella at #COP26. Ella's death from #dirtyair was the first to be recognized by a court in 2020: https://t.co/mf8LyLAsmb — Health Policy Watch – Global Health News Reporting (@HealthPolicyW) November 5, 2021 Like many Londoners, and many more urban dwellers in low- and middle-income cities around the world, Ella had lived in a heavily trafficked and heavily polluted neighbourhood. Shifting travel to greener modes, greening cities with more trees and making cities more walkable are among the climate strategies that health forces are advocating, and could all make a difference to the next generation. “Be serious, stop burning fossil fuels because those fossil fuels go into the air and into my lungs and yours. When you think about the planet, think about a couple of little, pink lungs,” said Dr Maria Neira, Director of the Department of Public Health, Climate & Environment, at the event. She noted that some 90% of the world’s population is exposed to unhealthy air pollution levels, leading to seven million deaths a year. Children among those worst affected The COVID-19 pandemic and climate change have created a perfect storm for increased malnutrition, child wasting and stunting, and maternal anaemia in parts of Africa. The fact that children are among those worst affected by climate change is underscored by a new review of the knowledge about climate change on child health, published by the Lancet on Sunday. “Present and future generations of children bear and will continue to bear an unacceptably high disease burden from climate change,” states the review’s authors, a group of Swedish experts from the Karolinksa Institute and elsewhere. “Through its far-reaching impact on all parts of society, climate change will challenge the very essence of children’s rights to survival, good health, wellbeing, education, and nutrition as enshrined by the Convention on the Rights of the Child and emphasised in the UN Sustainable Development Goals,” they note. “Climate change threatens to exaggerate the vulnerabilities of children and other populations at risk and could substantially hamper future progress and possibly even reverse the improvements made in child survival and wellbeing during recent decades,” concludes the review, suggesting that climate change needs to be better integrated into the SDG goals that cover children’s health overall.” Glasgow moment for health advocates Woman receives food assistance after widespread flooding the Horn of Africa and East Africa in 2020, linked by meterologists to climate change. But air pollution is only one of a range of ways in which our addiction to fossil fuels is delivering a double whammy to health – and children’s health in particular. Other, even more direct impacts include deaths and illness from extreme heat, storms, flooding, fires and drought. In addition, reduced food production capacity, an expanding geographic range for many infectious diseases, and increasing risk of new animal-borne diseases leaping from the wild to burgeoning cities – as SARS-CoV2 did – are imminent threats too. Given the rapid pace of climate change, “it won’t be long before the entire population of the world is affected, directly or indirectly,” said Julia Gillard, chair of the board of the UK-based philanthropy, Wellcome Trust and former Australian Prime Minister. Gillard was speaking at the COP26 “Global Conference on Health and Climate Change,” co-hosted by the World Health Organization (WHO) in Glasgow on Saturday. At the conference, co-sponsored by Wellcome, three UK-based universities and civil society groups, speakers warned of the burgeoning global health crisis that would result from inaction on climate change. “We are used to talking about climate as an environmental challenge, an economic challenge, an equity challenge. But it is also one of the most urgent health challenges facing us all today,” said Gillard. #Breaking #COP26: Health and Climate Experts Warn of Climate-Related Health Crisis https://t.co/kLWSb4Ilkc @JuliaGillard @DrTedros @WHO @Centre @JeniMiller @GCUclimatejust @jafryt @DrMariaNeira — Global Climate and Health Alliance (@GCHAlliance) November 6, 2021 Integrated policies not just global goals Sir Andy Haines, Professor of Environmental Change and Public Health at the London School of Hygiene and Tropical Medicine, speaking at the COP26 Climate and Health Summit. Tackling the root sources of climate change more rapidly can generate immediate savings for health systems and societies. But that will require not only big picture targets but a complete rethinking of policies, regulations, taxes and finance incentives at national and local levels, experts at the conference pointed out. “We need people to work together for integrated solutions,” said Professor Andy Haines of the London School of Hygiene and Tropical Medicine, who has written extensively on the planetary limits of not only temperature but also water, agricultural and forest ecosystems, which humankind needs to preserve to survive and thrive. Integration means recognising, for instance, that “the minister of transport is probably more a minister of health than the minister of health”, said Richard Smith, president of the UK Health Alliance on Climate Change. Commitment to ending financing for fossil fuel Twenty-six countries, including the US, UK, Canada and Italy, as well as the European Investment Bank and the French development agency, Agence Française de Développement, signed a commitment late last week to “end new direct public support for the international unabated fossil fuel energy sector by the end of 2022, except in limited and clearly defined circumstances that are consistent with a 1.5°C warming limit and the goals of the Paris Agreement”. The signatories also committed to prioritising their support “fully towards the clean energy transition”, using their resources to “enhance what can be delivered by the private sector”. They also commit to trying to persuade other governments, export credit agencies and public finance institutions to implement similar commitments into COP27 and beyond. According to WHO climate scientist Dr Diarmid Campell-Lendrum, $5.9 trillion is spent on direct and indirect subsidies to the fossil fuel industry each year. “We need to stop spending money on the wrong things and start spending it on the right things,” said Campbell-Lendrum, who cycled 1,600 km from Geneva to the Glasgow summit to drive home his point. He bore with him a letter calling for more climate action, signed by some 300 organisations, representing some 45 million health care professionals around the world. In London, Campbell-Lendrum was met by a raft of other climate cycle enthusiasts who continued the relay, getting the letter to Glasgow, where it was delivered to the COP26 leadership. https://twitter.com/i/status/1454817969276690436 Image Credits: Christine Olson/Flickr, IFRC, Paul Chappells. The African Medicines Agency Countdown 05/11/2021 Editorial team Thirty-nine of the African Union’s 55 member states have now signed and/or ratified the African Medicines Agency Treaty, as of 6 July 2024, with Kenya, the Democratic Republic of Congo and Cape Verde amongst the latest to swing behind the treaty. As the countdown for other nations to sign continues, Health Policy Watch is tracking progress on our AMA Countdown, website developed in collaboration with the African Medicines Agency Treaty Alliance. Here you can find the latest data on who has signed the treaty, ratified the treaty – and who is yet to sign – as well as links to sources and resources related to the African Medicines Agency Treaty process: Multimedia available for download: Find up-to-date infographics describing what countries have signed, signed and ratified, and signed, ratified and deposited the AMA treaty – in .png and interactive formats available for embed or download. African Union FAQs on the AMA Treaty Click to access 41269-doc-AMA_FAQs_rev.pdf Official African Union infographic repository Multilingual links to the AMA Treaty: The AMA Treaty in English: The AMA Treaty in French: The AMA Treaty in Arabic: The AMA Treaty in Portuguese: African Medicines Agency Treaty Alliance: AMATA joint statement, 5 November 2021, at the time that the AMA Treaty came into force. Breaking: Majority of African Countries Have Now Signed African Medicines Agency Treaty, Enabling Better Access to Newer, Safer Medicines 05/11/2021 Kerry Cullinan & Elaine Ruth Fletcher Pharmacy at Zouan health centre, Cote d’Ivoire; creation of an African Medicines Agency is intended to streamline regulatory approvals, improving quality and availability of medicines. Signatories to the new African Medicines Agency Treaty have now reached 28 countries – more than half of the African Union’s 55 member states – with the balance tipping as Uganda signed the treaty instrument last week. On Friday, 5 November, after more than a decade of preparations, the African Medicine Agency (AMA) treaty also came into force officially – clearing the way for the AMA to begin operations as a formal entity. And support for the treaty seemed to be picking up momentum with Cote d’Ivoire also signing the treaty on 29 October just ahead of Uganda’s signature on 3 November. See all the data here on our special website: African Medicines Agency Countdown, where we will be tracking all the latest developments in stories and interactive infographics. Despite the building support for the AMA, it will take more time, money and most of all – signatories from more of Africa’s powerhouse nations – to ensure that the new AMA entity can fulfill its mandate to ensure more rapid access to safer, newer and higher quality medicines across the continent. South Africa, Nigeria, Kenya and Ethiopia are among the 27 AU member states that have yet to even sign, yet alone ratify, the treaty document, which was first approved by the African Union in 2019. But with the AMA treaty coming into full force, exactly one month after the first 15 countries ratified and deposited the treaty instrument, no one is losing time. An AU meeting, set for February 2022, will select a country to host the new AMA headquarter and operations. Following that, formal structures will have to be set up and money raised to support its many crucial tasks. While a long road remains, AMA special envoy, Michel Sidibé said that the treaty’s entry into force is a ‘historic moment’. Historic moment today with the entry into force of the African Medicines Agency treaty. Bravo to the member states! We are grateful to President @AUC_MoussaFaki for his inspirational leadership and thank @AmiraDSA, @NEPAD_Mayaki, @DrTedros and all partners for their support. pic.twitter.com/a9IFitbFWz — Michel Sidibé (@MichelSidibe) November 5, 2021 COVID pandemic has sharpened the need for a continent-wide medicines agency The African Medicines Agency Treaty Alliance (AMATA), a coalition of patient civil society groups, academic institutions and industry, congratulated the first 15 African countries to ratify and deposit the treaty. AMATA called upon all other AU member states to quickly follow suit. Some 28 countries have so far signed the treaty, the majority in western Africa. Among those signatories, 10 have yet to ratify the treaty and three have still to deposit their ratifications with the African Union. The COVID-19 pandemic has sharpened the need for a continental agency that is able to fast-track approval for crucial vaccines and other medical products, AMATA said in its satement Friday: “COVID-19 has demonstrated that health security will only be achieved through concerted efforts and cross-border collaboration. “We call on all AU Heads of State to seize this historic opportunity to have one regulatory affairs oversight across the continent to enhance national, regional and continental regulation of medical products and oversee rapid and effective market authorization of safe, quality, effective and accessible medical products, for the good of all African people.” AMATA also called on the AMA Governing Board to rapidly move to put into place: A solid governance structure; Robust regulatory infrastructures; Adequate financial and human resources. AMATA also asked that the AMA governing board “recognise patients as key partners in the management structures and development of the agency”. Need for more AMA treaty signatories and quick operationalization Dr Maïmouna Diop Ly , AMATA board member AMATA executive board member Dr Maïmouna Diop Ly told Health Policy Watch that three critical tasks lay ahead in order for the agency to be successful. “There is a need to ensure that a critical number of countries sign the treaty to enable a quick operationalization of AMA,” said Diop Ly. “The statutory organs – the conference of state parties, governing board, secretariat and technical committees – should be put in place to ensure its functionality,” she added. “Finally, the allocation of adequate resources from countries’ contribution and partners is needed and should be part of the discussion of 2022 national budgets,” concluded Diop Ly, who is a health specialist with the African Development Bank and an advisor to the Senegal-based public health NGO, Speak-Up Africa. Potential lies to reduce market barriers to new medicines and fight fakes Andy Gray, senior lecturer in pharmacology at the University of KwaZulu-Natal in South Africa, said that AMA’s greatest potential lies “in the field of harmonisation of regulatory systems, which should reduce the barriers to market entry in Africa”. “The AMA is not intended to be a supranational regulator, and will not make decisions in the way the EMA does, but it could help in bringing national medicines regulatory authorities together, simplifying systems and reducing redundancy,” explained Gray. Over a quarter of the continent’s medicines are substandard or falsified, while only 2% are produced in Africa, according to AUDA. Through the harmonized regulatory framework, norms and standards, AMA will enable better access and equity to safe, quality medicine, medical products to African patients. This will also bring access to new and innovative technology for vaccines, medicine, medical devices, etc that will serve patients. The huge challenge of expanding universal health coverage – including health insurance – can also be advanced more systematically, with the support of new AMA structures – which should ease affordable access to medications, experts say. Proposed nearly a decade ago A continental medicine agency was first proposed a decade ago, and African Union member states adopted the AMA treaty almost three years ago. But the treaty could only be enforced once 15 AU member states had formally notified the AU Commission that they had ratified the treaty. This happened 30 days ago, when Cameroon became the 15th country to do so, thus setting in motion the formal establishment of the agency. The main aims of the AMA, as listed by the AU Development Agency (AUDA), are to: Support the growth of local pharmaceutical production Evaluate medical products to treat priority diseases identified by the AU Regularly inspect, coordinate and share information about products that are authorised for marketing. Coordinate reviews of clinical trial applications for vaccines and assess product dossiers such as bio-similars. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites. Collaborate with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs) to identify substandard and fake medical products Develop common standards and regulations, which will ensure that the continent’s legislation is harmonised. Responding to the medical crisis caused by COVID-19, the International Alliance of Patients’ Organizations (IAPO) helped to set up a lobby group, the African Medicines Agency Treaty Alliance (AMATA), to push for the speedier establishment of the agency. AMA ‘critically important’ says United States Meanwhile, Jessie Lapenn, the US Ambassador to the African Union, described the AMA as critical important to improving health security in Africa. “The AMA will be another critically important African institution that is part of the broader architecture that will be crucial for strengthening the continent’s health security,” Lapenn said at Thursday’s Africa Centres for Disease Control media briefing. “The US government and US private sector are very much looking forward to collaboration with AMA,” Lapenn added. Along with Cameroon, other countries to have both ratified the AMA and “deposited the instrument of ratification” at the AU (a letter from the head of state informing it of ratification) are predominantly west and north African, and/ Francophone nations, including: Algeria, Benin, Burkina Faso, Gabon, Guinea, Mali, Mauritius, Niger, Seychelles, and Sierra Leone. That may be due, in part, to the fact that the AU’s Special Envoy on the AMA is Michel Sidibé, Mali’s ex-Minister of Health. Now it will be up to southern, eastern and northern Africa to catch up – although Rwanda, Namibia and Zimbabwe have also been among the first to have ratified and deposited the treaty instrument. They were followed by Uganda, which signed the treaty on November 3. https://twitter.com/sabrinah_nati/status/1456617479430709249 Pharma groups welcome AMA’s creation Pharmaceutical companies have long complained about how complicated it is to get medicines approved in Africa and how long it takes – particularly in comparison to Europe, which processes applications via a central European Medicines Agency (EMA). A significant number of African countries’ national medicine regulatory authorities are under-resourced and lacking in expertise. Greg Perry, Assistant Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), welcomed the landmark moment where the treaty has now come into force, describing it as “one step closer to achieving a continent-wide regulatory agency”. “We look forward to the full implementation of the AMA, which will be a game-changer for all Africans to access safe, effective and quality medical products in a timely manner,” said Perry. -Updated on 8 November, 2021 Image Credits: James Oatway/IMF – Healthcare Focus , ©EC/ECHO/Anouk Delafortrie, LinkedIn. Pfizer Says New Anti-Viral Drug Combination Cuts Risks Of Serious COVID-19 By 89% 05/11/2021 Aishwarya Tendolkar Pfizer’s experimental pill works by inhibiting replication of SARS-CoV2 virus. Pfizer Friday announced that its experimental COVID-19 oral antiviral drug PAXLOVID™ reduced risks of hospitalization and death by 89% among patients who received the drug within the first three days of their illness. The company said it had stopped its Phase 2/3 trial on the drug owing to the success rate seen in an interim analysis of 1,219 adults enrolled in the study – who also had chronic health conditions placing them at higher risk of severe COVID. Pfizer is the second pharma firm, after Merck Sharp & Dohme (Merck), to announce highly promising results for an oral drug treatment that reduces serious COVID-19 illness – although the Pfizer results were even more stunning. PAXLOVID™ has the potential to eliminate up to nine out of ten hospitalizations, Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said in a press release. It’s a gamechanger,” Pfizer CEO Albert Bourla told @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” If approved for emergency use by the United States Food and Drug Administration (US FDA), PAXLOVID™ would become the first oral COVID antiviral of its kind. The novel treatment includes a newly- designed SARS-CoV-2-3CL protease inhibitor used in combination with a common anti-HIV drug, ritonavir. Bourla told CNBC that the filing for the drug is expected to be submitted before the U.S. Thanksgiving holiday on Nov. 25. “It’s a gamechanger,” Pfizer CEO Albert Bourla tells @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” https://t.co/IUYCAbZUu9 pic.twitter.com/QTFfJBizPs — CNBC (@CNBC) November 5, 2021 Pfizer’s results more impressive than Merck’s The Pfizer announcement follows Merck’s announcement last month that it’s new oral pill, molnupiravir, had reduced the risks of hospitalization and death by some 50% among people with mild or moderate COVID. The Merck pill, which was approved by UK regulators last week, introduces errors into the genetic code of the SARS-CoV2 virus that it targets, slowing virus replication. Pfizer’s reported results were even more impressive, however. Based on a primary analysis of interim data from 1,219 at-risk adults who were enrolled by September 29, 2021, only three people administered the drug within three days of sympton onset were hospitalized through day 28 of their illness, with no deaths. In the control group, 27 people were hospitalized, with seven subsequent deaths. When the company decided to stop recruiting more patients, their enrollment had reached 70 percent of the planned 3,000 patients across North and South America, Europe, Africa, and Asia. Pfizer drug is based upon a novel protease inhibitor, PF-07321332, that blocks the activity of the enzyme that the coronavirus needs to replicate. Co-administration of ritonavir means that protease inhibitor remains active in the body for longer periods of time to combat the virus. Treatment involves the administration of three PAXLOVID™ pills, twice a day, for five days. Pfizer says it will also ensure equitable access to new drug formulation While Merck’s molnupiravir pill is set to be licensed for generic production in most low- and middle-income countries, Pfizer said that it will offer PAXLOVID™ worldwide, through a tiered pricing approach – while maintaining control of its IP. Last week, Merck and the Medicines Patent Pool signed an agreement that paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell their treatment molnupiravir at discounted prices to more than 105 countries worldwide, once the drug receives approval by the World Health Organization. Pfizer, in contrast, said that its tiered pricing would be “based on the income level of each country to promote equity of access across the globe. “High and upper-middle income countries will pay more than lower income countries,” Pfizer said, adding that it had already entered into advance purchase agreements with “multiple countries and is in negotiations with several others” – without naming which. “Pfizer has also begun and will continue to invest up to approximately $1 billion to support the manufacturing and distribution of this investigational treatment, including exploring potential contract manufacturing options to help ensure access across low- and middle-income countries, pending regulatory authorization.” Image Credits: Wikimedia Commons, peterschreiber.media/Shutterstock . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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New Report Predicts 2.4°C Warming as COP26 Negotiators Race to Reach Climate Agreement – ‘Health’ Missing from Draft 10/11/2021 Kerry Cullinan COP26 president Alok Sharma A draft agreement released by UN Climate on Wednesday “calls upon parties to accelerate the phasing out of coal and subsidies for fossil fuels” – as countries work toward reaching consensus by the time the Glasgow Climate Conference (COP26) ends on Friday. The word ‘health’ also was noticeably absent from the draft text, reflecting the continued failure of the global community to recognise and address the intrinsic linkages between planetary and human well-being. Despite a recent spate of promises, including new pledges by the US and China, limiting global warming to 1.5° Celsius remains well out of reach. Even if all commitments are met, the world would still see 2.4°C warming by the end of the century, experts now predict. That was the conclusion of the non-profit Climate Action Tracker, which added up the most recent country pledges – or Nationally Determined Contributions (NDCs) – for CO2 reductions – translating those into forecasts for expected temperature rise. Target shortfalls reported by Climate Action Tracker. Earlier calculations had estimated a 2.7°C temperature rise – showing slight gains in the slow race to carbon neutrality. Dr Stephen Cornelius, the World Wildlife Fund’s chief advisor on climate change, described the country pledges as “woefully inadequate”. “COP26 has gotten further than Paris, but we are nowhere near the 1.5°C needed to avoid the worst impact of climate change,” Cornelius told a media briefing on Wednesday. However, he welcomed the draft’s recognition of the importance of science, including reference to the “code red” warning contained in a recent report issued by the Intergovernmental Panel on Climate Change (IPCC) on the urgency of climate action. ‘Wreckers’ like Saudia Arabia and Australia will try to weaken text Greenpeace International Executive Director Jennifer Morgan described the draft declaration as “a polite request that countries maybe, possibly, do more next year”. “We’ve just had a landmark study showing we’re heading for 2.4°C of warming,” said Morgan. “The job of this conference was always to get that number down to 1.5°C, but with this text, world leaders are punting it to next year.” #COP26: The new draft final decision text published today is not a plan to solve the climate crisis, it’s an agreement that we’ll all cross our fingers and hope for the best. It’s a polite request that countries maybe, possibly, do more next year. That’s not good enough. (1/2) — Jennifer Morgan (@climatemorgan) November 10, 2021 Greenpeace wants an agreement that is much stronger on finance for countries to mitigate and adapt to climate change. It also wants a commitment from countries to report annually – instead of every five years – on “new and better” plans until the world is able to reduce the global warming trajectory to the 1.5°C goal. While the language calling for an accelerated phase out fossil fuel subsidies, estimated to exceed $5 trillion annually, is seen as a signal of progress, there is no timeline for that to take place. And Morgan predicted that “wreckers like the Saudi and Australian governments” would try to delete the call for an accelerated phaseout of coal and fossil fuel subsidies from the draft. UK Green MP Caroline Lucas also condemned the draft, saying that it “utterly fails to rise to the moment” by failing to phase out all fossil fuels not just coal. Today’s draft #COP26 draft decision utterly fails to rise to the moment. The time for expressing “alarm & concern” is over – we need urgent action *now* & a pledge to phase out *all* fossil fuels, not just coal, which accounts for less than half the emissions problem. — Caroline Lucas (@CarolineLucas) November 10, 2021 COP26 delegates ignore warnings that fossil fuel subsidies are dangerous to health Fossil fuel subsidies have been repeatedly decried by the World Health Organization and other health experts at a series of health-focused COP26 events as particularly pernicious. Such subsidies, WHO points out, fuel dirty energy and transport sources – leading to air pollution emissions that kill an estimated 7 million people a year – while also discouraging investments in cleaner solutions that would be more cost-effective for societies overall. But the draft final COP statement had nary a word about health – or the climate-air pollution nexus plaguing many developing cities, particularly in South-East Asia. “Nearly half a billion will suffer severe health harm from north India’s air pollution even as COP26 offers up unambitious targets to a world at the brink of extinction,” stated the Indian NGO Care for Air. Nearly half a billion will suffer severe health harm from north #India’s #airpollution even as #COP26 offers up unambitious targets to a world at d brink of #extinction from#carbonemissions @HealthPolicyW @DrMariaNeira @UNEP @WHO @Jane_Burston @EPIC_India @1kenlee @dpcarrington — Care for Air (@CareForAirIndia) November 10, 2021 Paradoxically, COP will be concluding just as northern India’s seasonal air pollution emergency begins – a situation seen every autumn when smoke from crop stubble-burning in rural areas drifts toward Delhi, where it combines with a potent mix of fumes from construction, traffic, waste burning, and firecrackers celebrating the Hindu Diwali festival. Grand promises by politicians last year to devise more sustainable alternatives for farmers – such as composting or machine threshing of crop stubble – to have so far failed to materialize. ‘Massive credibility gap’, absence of clear targets for fossil fuel phase-out In Glasgow, politicians seemed anxious to avoid making the potent linkages between climate change and millions of deaths a year from air pollution. Language in the draft agreement remained general and non-specific around critical points, such as setting a target or timeline for actually phasing out fossil fuels. The draft agreement merely “invites parties to consider further opportunities to reduce non-carbon dioxide greenhouse gas emissions”. The statement does, however, go further than previous COP declarations in suggesting that a more holistic approach to the climate crisis is needed, emphasising the “critical importance of nature-based solutions and ecosystem-based approaches, including protecting and restoring forests, in reducing emissions, enhancing removals and protecting biodiversity”. Even so, “at the midpoint of Glasgow, it is clear there is a massive credibility, action and commitment gap that casts a long and dark shadow of doubt over the net zero goals put forward by more than 140 countries, covering 90% of global emissions”, Climate Action Tracker’s briefing document observed. The country targets for 2030 remain “totally inadequate”, added the report, estimating that they “put us on track for a 2.4°C temperature increase by the end of the century”. Another significant unresolved issue: LMIC financing COP26 President Alok Sharma confirmed at a plenary on Wednesday that while “some significant issues remain unresolved”, he expected “near-final” texts from the various negotiating groups by Thursday morning and a consensus document for adoption by the close of the summit on Friday. Aside from the inadequate emission targets, other sticking points concern financing, including agreement on finance for countries’ claims of climate change-related loss and damage – most of which are likely to be filed by low- and middle income countries. UK lead climate negotiator Archie Young told the plenary that more work also needs to be done on the “significant finance agenda and the $100-billion goal” – the annual finance target set by the Paris Agreement to be available by the end of 2021 to assist LMIC countries to mitigate and adapt to climate change. The draft appeals to “the private sector, multilateral development banks and other financial institutions to enhance finance mobilization in order to deliver the scale of resources needed to achieve climate plans, particularly for adaptation”. Glasgow flooded with fossil fuel lobbyists While the global business and finance community is said to have an unprecedented presence at COP26 – the largest contingent at the entire conference – is in fact the fossil fuel industry, an analysis of participants found. Some 503 fossil fuel lobbyists are registered at Glasgow, according to the analysis by the civil society groups, Corporate Europe Observatory (CEO) and GlobalWitness.org. The report “Glasgow Calls Out Polluters” found that if the fossil fuel lobby were a country delegation at COP it would be the largest with 503 delegates – two dozen more than the largest country delegation. In addition, the report found that: Over 100 fossil fuel companies are represented at COP with 30 trade associations and membership organisations also present; Fossil fuel lobbyiests are members of 27 official country delegations, including Canada, Russia and Brazil. Fossil fuel lobbyists dwarf the UNFCCC’s official indigenous constituency by around two to one. The fossil fuel lobby at COP is larger than the combined total of the eight delegations from the countries worst affected by climate change in the last two decades – Puerto Rico, Myanmar, Haiti, Philippines, Mozambique, Bahamas, Bangladesh, Pakistan. Image Credits: Climate Action Tracker., Climate Action Tracker. Fifty Countries Commit to ‘greening’ their healthcare systems at COP26 09/11/2021 Kerry Cullinan Solar panels provide electricity to Mulalika Health Clinic in Zambia. Fifty countries have committed to building sustainable, low-carbon and climate-resilient healthcare systems, and 14 of these have set net-zero carbon emission target dates from as early as 2030. This emerged from a health and climate change session at COP26, the United Nations climate conference in Glasgow, that was co-hosted by the World Health Organization (WHO). “As part of a green and resilient recovery from COVID-19, we need to recognise the role of health systems as emitters accounting for 4% to 5% of global emissions,” said Dr Rachel Levine, US Assistant Secretary in the Department of Health and Human Services. If the global health care sector were a country, it would be the fifth-largest greenhouse gas emitter on the planet, according to Health care’s climate footprint, a report produced by Health Care Without Harm. “These emissions are predicted to increase as health systems develop, and demographic changes lead to increasing healthcare demand,” said Levine, adding that the countries that had committed to building low carbon health systems were responsible for about one-third of all health sector emissions globally. The US has committed to decarbonizing the nation’s health systems by reducing greenhouse gas emissions in the federal health system, as well as the private sector via “incentives, guidance, technical assistance and regulatory approaches and partnerships”, Levine added. “The United States action on health system decarbonization is influential and critical. The US accounts for approximately 25% of the world’s health sector greenhouse gas emissions. This commitment to reducing greenhouse gases will also result in decreasing the negative health impacts of air pollution, such as premature death, heart disease, stroke, and more,” said Levine. Breaking: #COP26, over 50 countries have committed to decarbonize their #health systems a first ever COP presidency event on climate & health.Health sector is stepping up to decarbonize & calling global leaders to do the same!#ClimateEmergency #ClimatePrescription @HCWHGlobal pic.twitter.com/iwPhsdUJxW — Global Climate and Health Alliance (@GCHAlliance) November 9, 2021 Josh Karliner, International Director of Program and Strategy at Health Care Without Harm, said that “there is a growing global movement of hospitals and health systems” that were already reducing their carbon emissions. “There are more than 54 institutions in 21 countries representing more than 14,000 hospitals and health centres committed to race to zero,” said Karliner. “This is from Newcastle to New York. It’s from Sao Paulo to South Africa. It’s from Kerala to California.” Karliner explained: “We’re seeing hospitals and health systems taking action by investing in renewable energy by investing in zero-emission buildings and transport; by substituting anaesthetic gases with more sustainable alternatives; by implementing sustainable procurement programmes to purchase sustainably produced food, energy-efficient medical devices and lower carbon pharmaceuticals.” However, ‘greening’ health systems is a massive, expensive undertaking that requires many fundamental changes covering architecture, waste disposal, energy, and water. A flash flood in Fiji in 2018 Small island states struggle to make health services climate-resilient Dr Satyendra Prasad, Fiji’s permanent representative to the UN, told the meeting that his country struggled to keep health services running when faced with superstorms and other adverse weather events. “It is quite tragic when your doctors and nurses are being evacuated when they should be providing frontline services to people who have been injured and who need care,” said Prasad. “This conundrum is very tough, and it is a conundrum that exists for so many countries,” said Prasad, adding that Fiji is in the process of relocating health services to higher ground and equipping facilities with renewable energy to enable them to remain operational after major cyclones of flooding. “We losing fewer lives to extreme weather catastrophes. We are losing more lives to waterborne diseases and all the diseases that come following a major catastrophe such as flooding, and cyclone,” he added. Similarly, the Maldives has seen the emergence of vector-borne tropical diseases such as Dengue, which it didn’t use to have, said Aminath Shauna, Minister of Environment, Climate Change and Technology in the Maldives. “The Maldives is one of the most vulnerable island nations to climate change. We are experiencing things that we thought would happen towards the end of the century,” said Shauna. “Our coral reefs are dying. We are running out of fresh water. Our islands are eroding, and our islands are getting more frequently flooded, which poses a significant challenge to our public health system,” she added. To mitigate these risks, the Maldives has integrated climate risks into health policy, developed climate-sensitive disease programmes and is promoting climate-resilient healthcare facilities that are able to withstand climate events. It is also working to ensure that its essential services such as water, sanitation, waste management and electricity can still function during extreme weather events. “The Maldives health sector is also committed to initiating the greening of the health sector by adopting environment-friendly technologies and using energy-efficient services,” said Shauna. Finances for adaptation However, finances to make these changes are a challenge for countries like Fiji and the Maldives. Lack of finance has been a recurrent theme at COP26, with smaller countries with small carbon footprints appealing for reparations from large polluting countries to assist them to mitigate climate change. Former UK prime minister Gordon Brown and WHO Ambassador for Global Health Financing told the meeting that “you cannot cut investment in health at the expense of climate change – and you cannot cut investment in climate finance at the expense of health”. “We really have to recognise that we’re dealing with global public goods – the control of infectious diseases, a clean environment, clean air and a clean environment,” said Brown. “And we need to have a system of global burden-sharing where the richest countries that are responsible for the historic emissions and have the wealth and the capacity to pay, make good the funding that is necessary for mitigation and adaptation, and that includes the adaptation of healthcare systems, particularly in the poorest parts of the world,” said Brown. Despite the global commitment made at Paris COP to ensure $100 billion a year in financing to mitigate climate change by the end of this year, it looks like this target will only be reached in 2023. However, Brown stressed that if this target was not reached, it would deprive developing countries “of the opportunity not only to build coastal defences and renewable industries, but to build the healthcare systems that are necessary for resistance to droughts and famine, and also to pollution in the air”. .@WHO strongly welcomes commitments made at #COP26 by some countries to build health systems resilient to the impacts of the #ClimateCrisis, incl. extreme weather events, the increasing burden of diseases related to #airpollution and our warming planet. https://t.co/lDSceMsWlg pic.twitter.com/8dhOmL8QXM — Tedros Adhanom Ghebreyesus (@DrTedros) November 9, 2021 Addressing the meeting via a recorded message, WHO Director-General Dr Tedros Adhanom Ghebreyesus said that the changes the world needed to make to energy, transport and food systems to meet the Paris climate goals “would bring massive health gains”. He added that the WHO is committed to working with the countries that had committed to building greener health systems “for a healthier and more sustainable future”. Image Credits: UNDP/Karin Schermbrucker for Slingshot , World Meterological Organisation. Health Impacts of Climate Change Grab Eyeballs at COP26, But Lack of Finance Continues to be Major Issue 09/11/2021 Disha Shetty WHO Director-General Dr Tedros receiving an open letter about climate change, signed by health professionals from around the world and organized by Doctors for XR. GLASGOW – Conversations on the health impacts of the climate crisis have grown this year at COP26 – the United Nation’s annual climate conference, now in its 26th year. Experts hope that this increase in conversation will lead to greater awareness about the health crisis exacerbated by the climate crisis and lead to concrete action in the months and years ahead. Around 85% of countries now have a designated focal point for health and climate change in their ministries of health, according to the 2021 World Health Organization (WHO) health and climate change global survey report released on Monday. But countries report that a lack of funding, impact of COVID-19, and insufficient resource capacity are major barriers to progress. Many countries are unsupported and unprepared to deal with the health impacts of climate change, according to the survey. “We are here at COP26 to urge the world to better support countries in need, and to ensure that together we do a better job of protecting people from the biggest threat to human health we face today,” said Dr Maria Neira, WHO Director of Environment, Climate Change and Health. At the sidelines of the climate negotiations, the WHO held a day-long conference over the weekend focussed on the climate and health that was attended by high-level delegates. “We are used to talking about climate as an environmental challenge, an economic challenge, an equity challenge. But it is also one of the most urgent health challenges facing us all today,” said Julia Gillard, former Prime Minister of Australia and Chair of Wellcome Trust. The conference sought to highlight that while climate change affects health, the mitigation strategies will also automatically translate into health gains. “Health must become the beating heart of climate action”, said Jeni Miller, executive director of the Global Climate and Health Alliance. “Political leaders must prioritise health and social equity, emission reduction and impact mitigation over politics, profit and unproven technological fixes. The decisions made during COP26 will define the health and wellbeing of people all over the world for decades to come”. Dr. Maria Neira, Director of WHO Environment, Climate Change and Health Highlighting the health gains of clean air In the first week of the COP26 negotiations, WHO also co-hosted a panel discussion on both the health and climate gains of clean air that this reporter helped moderate. Given that air pollution alone kills around seven million people worldwide every year, any progress on this would save millions of lives annually. The event also came at a time when air pollution in India’s capital, Delhi, had reached lethal levels following last week’s celebration of the festival Diwali, during which people set off fire crackers. The densely populated Indo-Gangetic plain where Delhi is, is one of the world’s most polluted regions, and emerging research suggests the source of air pollution is local. Dr Neira said that the time for conversations was over, the evidence on air pollution is clear and it is time now to act. As many of the pollutants that cause air pollution also lead to a greenhouse effect, the WHO has made efforts to highlight the dual climate and health gains of improving air quality that disproportionately affects vulnerable groups like children and the elderly. Developing countries are pushing for climate finance and technology transfer at COP so that they have the support they need to clean their air but much of this also needs to happen at sub-national levels, especially at city-level, that will also require local action, highlighted Ani Dasgupta, President and CEO of World Resources Institute (WRI). Health not a part of text of negotiations It was clear although that while health is a part of the growing conversation, it is far from figuring in the main climate negotiations. A former negotiator elaborated that, given how bitter and exhausting climate negotiations are, adding health to the text might not be practical and that any reduction in global carbon emissions will automatically translate into health gains. At this year’s COP there is also a push to hold the rich countries accountable for the loss and damage being caused by the climate crisis in vulnerable nations. Public health crisis, even though directly caused or exacerbated by extreme climate events, aren’t part of these negotiations either. “I don’t see it coming up very directly into the loss and damage negotiations here because the negotiations are more about the overarching structures, not necessarily on a very particular theme,” said Sven Harmeling, the International Climate Policy Lead, from CARE and CAN Europe. He did add that it does factor in how many of the developing countries think about the damages being caused. WHO’s latest survey backs his view. It found that virtually all (94%) countries have incorporated health considerations in their nationally determined contributions (NDCs) to the Paris Agreement, voluntary pledges by the government to reduce their carbon emissions. Emissions from coal-burning power stations are causing air pollution that is affecting millions of people worldwide. Highlighting emissions from healthcare and silos Among the conversations at COP26 that centred on healthcare was also how to get the healthcare sector to reduce its own emissions. A 2019 report from Healthcare Without Harm based on 2014 data on carbon emissions suggests that globally 4.4% of carbon emissions are from the healthcare sector itself. The US health sector had the largest greenhouse gas emissions. Andrea Epstein, climate programme manager for Latin America at Healthcare Without Harm said that number is probably higher now that despite the region being a part of the developing world, there is a growing interest in decarbonizing the health systems. “The problem is of course the means of implementation. Not just the financing and the technology but also having the capacity for that. So while it is a challenge, the interest is there.” Members of the civil society organisations present at COP highlighted the silos that continued to exist in conversations around health, climate and food – all of which affect each other but are handled by different organisations. Disha Shetty is reporting from COP26 as a part of the 2021 Climate Change Media Partnership, a journalism fellowship organized by Internews’ Earth Journalism Network and the Stanley Center for Peace and Security. Follow her on Twitter @dishashetty20 Image Credits: WHO/Chris Black, Planetary Health Eastern Africa Hub. Pandemic Treaty Offers Opportunity to Repair Fault Lines in COVID-19 Response – and Address Equity 09/11/2021 Kerry Cullinan A nurse takes the temperature of a child suspected of COVID-19 symptoms in a Lebanese public health centre. An international pandemic treaty based on equity could be the antidote to current weaknesses and imbalances in the global response to COVID-19, according to a group of influential authors in a Lancet paper published on Tuesday. A number of the authors are associated with The Independent Panel for Pandemic Preparedness and Response chaired by Helen Clark and Ellen Sirleaf Johnson, which was set up to assess the World Health Organization’s (WHO) response to COVID-19. Based on a timeline developed by the panel that lays out the global COVID-19 response, the authors conclude that the International Health Regulations (IHR) are too weak, and the required country actions are too slow, to protect the world against pandemics. Revised after the 2005 Severe Acute Respiratory Syndrome (SARS) outbreak, the IHR focus on balancing disease notification and health risks with international trade and travel considerations. They specify when and how Member States should notify WHO of a local disease outbreak, and what actions WHO and States should take after that notification. The IHR are currently the only legally binding international instrument governing countries’ obligations to report and respond to pathogens that could result in cross-border disease outbreaks and potential public health emergencies. In their review, the authors identified a number of significant IHR weaknesses, including: constraints on WHO reporting publicly about national events with pandemic potential; the need for greater specificity on the information that countries need to share with WHO; and a streamlined process to facilitate WHO verification of events within 24 hours of the first signals of an outbreak being received. Special World Health Assembly The article comes a few weeks before global leaders meet at a World Health Assembly special session (29 November – 1 December) to consider adopting an “instrument or treaty” to address pandemic preparedness and response. “It’s clear: if a new, fast-spreading pathogen were to emerge next month, the current IHR regime would not protect people and trade as intended,” said Dr Sudhvir Singh, lead author on the paper and an advisor to the Independent Panel. “We suggest change to the IHR and a new treaty or another instrument that would result in more information shared faster, WHO able to investigate rapidly, all countries moving immediately to assess risk; and tools, like tests and vaccines, available to all who need them.” Georgetown University’s Dr Alexandra Phelan added that “COVID-19 has shown that the existing obligations under the IHR are insufficient for our interdependent and digital world.” “Our analysis demonstrates that collectively, countries urgently need to update our international system to respond to the potential rapid spread of a high impact respiratory pathogen,” said Phelan. “We have concrete suggestions for ways in which the IHR may be revised or amended, as well as the approach and issues that must be covered in any new legal framework, like a pandemic treaty.” Four reasons for a pandemic treaty The authors advance four reasons why a pandemic treaty “presents the opportunity to enact comprehensive reform in pandemic preparedness and response”. “First, a pandemic treaty centred on the principle of equity would be an important signal of international commitment to guard against the entrenchment of global division and injustice.” A pandemic treaty offers an opportunity to “develop and instil norms of equity, justice, and global public goods of pandemic preparedness and response”, they argue. “Second, a pandemic treaty could provide high-level complementarity to the IHR and any potential post-pandemic reforms and proactive multidisciplinary approaches to zoonotic risk,” they argue. Their third argument is that a treaty establishes greater accountability, outbreak support, and global access to vital public health information. Finally, a pandemic treaty could provide the opportunity to develop “a solid evidence base for non-pharmaceutical interventions” that might prevent the next outbreak from becoming a pandemic. “The upcoming Special Session of the World Health Assembly is a critical opportunity for Member States to move ahead with strengthening the IHR and to agree on a process for negotiating a pandemic treaty. We must not lose this opportunity to protect global public health and future generations,” said Phelan. At a recent event hosted by G2H2, civil society organisations expressed fear that a pandemic treaty was a distraction from the TRIPS waiver. But Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver. Kümmel added that amending the IHR also would take time to negotiate. And a key question here is: “would they be a game-changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” Image Credits: UNICEF . Obama Critical of China and Russia’s ‘Dangerous Lack of Urgency’ in Climate Change at COP26 08/11/2021 Raisa Santos Former US President Barack Obama speaking at COP26 Former US President Barack Obama openly criticized two of the world’s largest CO2 emitting countries – Russia and China, for their “dangerous lack of urgency” in discussing the pressing matters of climate change this past week during COP26. Both Chinese President Xi Jinping and Russian President Vladimir Putin failed to make an appearance with other global leaders at the 26th United Nations Climate Change Conference in Glasgow, which Obama found to be “particularly discouraging,” as he addressed a room of climate experts at the event on Monday. “We need advanced economies like the US and Europe leading on [the issue of climate change]. But we also need China and India, we need Russia, just as we need Indonesia and South Africa and Brazil leading on this issue. We can’t afford anybody to be on the sidelines.” Obama noted that while there has been some progress made in the six years since the Paris Agreement, the legally binding international treaty on climate change, the world still falls short of their commitment to limit global warming to well below 1.5 C. “Here in Glasgow we see the promise of further progress. What is also true is that collectively and individually, we are still falling short. We have not done nearly enough to address this crisis.” “We are going to have to do more and whether that happens or not to a large degree is going to depend on you,” said Obama, calling for collective action from young people and politicians alike to take climate change seriously. Twenty countries pledge to end public finance of international fossil fuel development Although most nations have failed to be ambitious in their climate goals in the past week of COP26, said Obama, significant accomplishments and hard-won commitments have been made during the climate conference. One such commitment was for high-income countries to help low- and middle-income countries move away from fossil fuels. Back in September, US President Joe Biden told the UN General Assembly that the US would provide more than $11 billion in climate aid annually by 2024 to developing nations vulnerable to extreme weather and rising temperatures. In addition, the US and 20 other countries have pledged to stop publicly financing international fossil fuel development, with limited exceptions. “We will end new public direct support for the international unabated fossil fuel energy sector by the end of 2022,” the declaration read. The 20 countries that signed the pledge include Denmark, Italy, Finland, Costa Rica, Ethiopia, Gambia, New Zealand and the Marshall Islands, plus five development institutions including the European Investment Bank and the East African Development Bank. This deal does go further than a pledge made earlier in the year by the G20 to end international financing of coal-based power generation outside their own countries. However, this declaration does not include major Asian countries responsible for financing a majority of overseas fossil fuel projects. Climate change cannot be a partisan issue While collective action in fighting climate change requires international cooperation, Obama noted the geopolitical tensions that have arisen as a result of the pandemic, but called for the world to step up despite these tensions. “Climate change can’t be seen anywhere in the world as just an opportunity to score political points.” “Saving the planet isn’t a partisan issue. Nature, physics, science, do not care about party affiliation,” he added. Climate change, in the US particularly, has become a partisan issue, causing what Obama referred to as a “lack of leadership on America’s part” and the “open hostility towards climate science at the very top of the [US] federal government” that resulted from former President Donald Trump’s four years in office. Obama also pointed out that the lack of a stable congressional majority has prevented him and current President Joe Biden from taking an even stronger stance on climate change. However, Obama remain sconfident that Biden’s Build Back Better Framework, which would set the US on course to meet its climate goals, would be passed in coming weeks. The legislation, once approved by the US Congress, would devote at least US $1.7 trillion dollars to reduce greenhouse gas emissions by over a billion metric tons by the end of 2030. Young people have more at stake in the fight against climate change Greta Thunberg addresses climate strikers at Civic Center Park in Denver, Colorado. Thunberg is one climate activist Obama praised for inspiring millions in the fight against climate change. Though Obama noted that at times, he was “doubtful that humanity can get its act together before it’s too late”, this cynicism was countered by the prevailing efforts of young climate activists around the world. Addressing all the young people, who Obama said, had “more stake in this fight than anybody else,” he said: “I want you to stay angry. I want you to stay frustrated. Channel that anger, harness that frustration.” “Because that’s what’s required to meet this challenge. Solving a problem this big and this important has never happened all at once.” Image Credits: COP26, Andy Bosselman, Streetsblog Denver/Flickr. Children’s Health Hit Hardest by Climate Change – but Cleaner Air, Greener Cities and Healthier Foods Can Create Cascade of Benefits 07/11/2021 Elaine Ruth Fletcher Rosamund Kissi-Debrah, mother of 11-year Ella, whose 2013 death from severe asthma was the first to be recognized by a court as caused by air pollution. Greening cities, investing in urban bike lanes rather than new roads, and making plant-based foods cheaper and easier to access than ultra-processed foods. This is a doctor’s prescription for a healthier planet. As climate negotiators at Glasgow’s COP26 conference remain locked in debate over the big-picture ambition of targets for global CO2 emissions reductions, and how to finance them, health advocates are trying to raise the profile of climate policies that would yield far-reaching knock-on benefits to the health of almost everyone on earth – but particularly for children, women and people living in some the poorest nations of the world. “We have sacrificed children all around the world to air pollution,” said Rosamund Kissi-Debrah, noting that some 500,000 children a year die from air pollution. Kissi-Debrah was speaking at the COP26 “Triple Win Scenario” event on Friday, co-sponsored by the WHO and the World Resources Institute. Kissi-Debrah’s 11-year-old girl daughter, Ella, was one of those victims. But her death from severe asthma in 2013 set a precedent: it was the first to be recognised by a court anywhere in the world as air-pollution induced. "We have sacrificed children all around the world to #airpollution" – caused by the same sources of #climatechange: Rosamund Kissi-Debrah, mother of 9-year-old Ella at #COP26. Ella's death from #dirtyair was the first to be recognized by a court in 2020: https://t.co/mf8LyLAsmb — Health Policy Watch – Global Health News Reporting (@HealthPolicyW) November 5, 2021 Like many Londoners, and many more urban dwellers in low- and middle-income cities around the world, Ella had lived in a heavily trafficked and heavily polluted neighbourhood. Shifting travel to greener modes, greening cities with more trees and making cities more walkable are among the climate strategies that health forces are advocating, and could all make a difference to the next generation. “Be serious, stop burning fossil fuels because those fossil fuels go into the air and into my lungs and yours. When you think about the planet, think about a couple of little, pink lungs,” said Dr Maria Neira, Director of the Department of Public Health, Climate & Environment, at the event. She noted that some 90% of the world’s population is exposed to unhealthy air pollution levels, leading to seven million deaths a year. Children among those worst affected The COVID-19 pandemic and climate change have created a perfect storm for increased malnutrition, child wasting and stunting, and maternal anaemia in parts of Africa. The fact that children are among those worst affected by climate change is underscored by a new review of the knowledge about climate change on child health, published by the Lancet on Sunday. “Present and future generations of children bear and will continue to bear an unacceptably high disease burden from climate change,” states the review’s authors, a group of Swedish experts from the Karolinksa Institute and elsewhere. “Through its far-reaching impact on all parts of society, climate change will challenge the very essence of children’s rights to survival, good health, wellbeing, education, and nutrition as enshrined by the Convention on the Rights of the Child and emphasised in the UN Sustainable Development Goals,” they note. “Climate change threatens to exaggerate the vulnerabilities of children and other populations at risk and could substantially hamper future progress and possibly even reverse the improvements made in child survival and wellbeing during recent decades,” concludes the review, suggesting that climate change needs to be better integrated into the SDG goals that cover children’s health overall.” Glasgow moment for health advocates Woman receives food assistance after widespread flooding the Horn of Africa and East Africa in 2020, linked by meterologists to climate change. But air pollution is only one of a range of ways in which our addiction to fossil fuels is delivering a double whammy to health – and children’s health in particular. Other, even more direct impacts include deaths and illness from extreme heat, storms, flooding, fires and drought. In addition, reduced food production capacity, an expanding geographic range for many infectious diseases, and increasing risk of new animal-borne diseases leaping from the wild to burgeoning cities – as SARS-CoV2 did – are imminent threats too. Given the rapid pace of climate change, “it won’t be long before the entire population of the world is affected, directly or indirectly,” said Julia Gillard, chair of the board of the UK-based philanthropy, Wellcome Trust and former Australian Prime Minister. Gillard was speaking at the COP26 “Global Conference on Health and Climate Change,” co-hosted by the World Health Organization (WHO) in Glasgow on Saturday. At the conference, co-sponsored by Wellcome, three UK-based universities and civil society groups, speakers warned of the burgeoning global health crisis that would result from inaction on climate change. “We are used to talking about climate as an environmental challenge, an economic challenge, an equity challenge. But it is also one of the most urgent health challenges facing us all today,” said Gillard. #Breaking #COP26: Health and Climate Experts Warn of Climate-Related Health Crisis https://t.co/kLWSb4Ilkc @JuliaGillard @DrTedros @WHO @Centre @JeniMiller @GCUclimatejust @jafryt @DrMariaNeira — Global Climate and Health Alliance (@GCHAlliance) November 6, 2021 Integrated policies not just global goals Sir Andy Haines, Professor of Environmental Change and Public Health at the London School of Hygiene and Tropical Medicine, speaking at the COP26 Climate and Health Summit. Tackling the root sources of climate change more rapidly can generate immediate savings for health systems and societies. But that will require not only big picture targets but a complete rethinking of policies, regulations, taxes and finance incentives at national and local levels, experts at the conference pointed out. “We need people to work together for integrated solutions,” said Professor Andy Haines of the London School of Hygiene and Tropical Medicine, who has written extensively on the planetary limits of not only temperature but also water, agricultural and forest ecosystems, which humankind needs to preserve to survive and thrive. Integration means recognising, for instance, that “the minister of transport is probably more a minister of health than the minister of health”, said Richard Smith, president of the UK Health Alliance on Climate Change. Commitment to ending financing for fossil fuel Twenty-six countries, including the US, UK, Canada and Italy, as well as the European Investment Bank and the French development agency, Agence Française de Développement, signed a commitment late last week to “end new direct public support for the international unabated fossil fuel energy sector by the end of 2022, except in limited and clearly defined circumstances that are consistent with a 1.5°C warming limit and the goals of the Paris Agreement”. The signatories also committed to prioritising their support “fully towards the clean energy transition”, using their resources to “enhance what can be delivered by the private sector”. They also commit to trying to persuade other governments, export credit agencies and public finance institutions to implement similar commitments into COP27 and beyond. According to WHO climate scientist Dr Diarmid Campell-Lendrum, $5.9 trillion is spent on direct and indirect subsidies to the fossil fuel industry each year. “We need to stop spending money on the wrong things and start spending it on the right things,” said Campbell-Lendrum, who cycled 1,600 km from Geneva to the Glasgow summit to drive home his point. He bore with him a letter calling for more climate action, signed by some 300 organisations, representing some 45 million health care professionals around the world. In London, Campbell-Lendrum was met by a raft of other climate cycle enthusiasts who continued the relay, getting the letter to Glasgow, where it was delivered to the COP26 leadership. https://twitter.com/i/status/1454817969276690436 Image Credits: Christine Olson/Flickr, IFRC, Paul Chappells. The African Medicines Agency Countdown 05/11/2021 Editorial team Thirty-nine of the African Union’s 55 member states have now signed and/or ratified the African Medicines Agency Treaty, as of 6 July 2024, with Kenya, the Democratic Republic of Congo and Cape Verde amongst the latest to swing behind the treaty. As the countdown for other nations to sign continues, Health Policy Watch is tracking progress on our AMA Countdown, website developed in collaboration with the African Medicines Agency Treaty Alliance. Here you can find the latest data on who has signed the treaty, ratified the treaty – and who is yet to sign – as well as links to sources and resources related to the African Medicines Agency Treaty process: Multimedia available for download: Find up-to-date infographics describing what countries have signed, signed and ratified, and signed, ratified and deposited the AMA treaty – in .png and interactive formats available for embed or download. African Union FAQs on the AMA Treaty Click to access 41269-doc-AMA_FAQs_rev.pdf Official African Union infographic repository Multilingual links to the AMA Treaty: The AMA Treaty in English: The AMA Treaty in French: The AMA Treaty in Arabic: The AMA Treaty in Portuguese: African Medicines Agency Treaty Alliance: AMATA joint statement, 5 November 2021, at the time that the AMA Treaty came into force. Breaking: Majority of African Countries Have Now Signed African Medicines Agency Treaty, Enabling Better Access to Newer, Safer Medicines 05/11/2021 Kerry Cullinan & Elaine Ruth Fletcher Pharmacy at Zouan health centre, Cote d’Ivoire; creation of an African Medicines Agency is intended to streamline regulatory approvals, improving quality and availability of medicines. Signatories to the new African Medicines Agency Treaty have now reached 28 countries – more than half of the African Union’s 55 member states – with the balance tipping as Uganda signed the treaty instrument last week. On Friday, 5 November, after more than a decade of preparations, the African Medicine Agency (AMA) treaty also came into force officially – clearing the way for the AMA to begin operations as a formal entity. And support for the treaty seemed to be picking up momentum with Cote d’Ivoire also signing the treaty on 29 October just ahead of Uganda’s signature on 3 November. See all the data here on our special website: African Medicines Agency Countdown, where we will be tracking all the latest developments in stories and interactive infographics. Despite the building support for the AMA, it will take more time, money and most of all – signatories from more of Africa’s powerhouse nations – to ensure that the new AMA entity can fulfill its mandate to ensure more rapid access to safer, newer and higher quality medicines across the continent. South Africa, Nigeria, Kenya and Ethiopia are among the 27 AU member states that have yet to even sign, yet alone ratify, the treaty document, which was first approved by the African Union in 2019. But with the AMA treaty coming into full force, exactly one month after the first 15 countries ratified and deposited the treaty instrument, no one is losing time. An AU meeting, set for February 2022, will select a country to host the new AMA headquarter and operations. Following that, formal structures will have to be set up and money raised to support its many crucial tasks. While a long road remains, AMA special envoy, Michel Sidibé said that the treaty’s entry into force is a ‘historic moment’. Historic moment today with the entry into force of the African Medicines Agency treaty. Bravo to the member states! We are grateful to President @AUC_MoussaFaki for his inspirational leadership and thank @AmiraDSA, @NEPAD_Mayaki, @DrTedros and all partners for their support. pic.twitter.com/a9IFitbFWz — Michel Sidibé (@MichelSidibe) November 5, 2021 COVID pandemic has sharpened the need for a continent-wide medicines agency The African Medicines Agency Treaty Alliance (AMATA), a coalition of patient civil society groups, academic institutions and industry, congratulated the first 15 African countries to ratify and deposit the treaty. AMATA called upon all other AU member states to quickly follow suit. Some 28 countries have so far signed the treaty, the majority in western Africa. Among those signatories, 10 have yet to ratify the treaty and three have still to deposit their ratifications with the African Union. The COVID-19 pandemic has sharpened the need for a continental agency that is able to fast-track approval for crucial vaccines and other medical products, AMATA said in its satement Friday: “COVID-19 has demonstrated that health security will only be achieved through concerted efforts and cross-border collaboration. “We call on all AU Heads of State to seize this historic opportunity to have one regulatory affairs oversight across the continent to enhance national, regional and continental regulation of medical products and oversee rapid and effective market authorization of safe, quality, effective and accessible medical products, for the good of all African people.” AMATA also called on the AMA Governing Board to rapidly move to put into place: A solid governance structure; Robust regulatory infrastructures; Adequate financial and human resources. AMATA also asked that the AMA governing board “recognise patients as key partners in the management structures and development of the agency”. Need for more AMA treaty signatories and quick operationalization Dr Maïmouna Diop Ly , AMATA board member AMATA executive board member Dr Maïmouna Diop Ly told Health Policy Watch that three critical tasks lay ahead in order for the agency to be successful. “There is a need to ensure that a critical number of countries sign the treaty to enable a quick operationalization of AMA,” said Diop Ly. “The statutory organs – the conference of state parties, governing board, secretariat and technical committees – should be put in place to ensure its functionality,” she added. “Finally, the allocation of adequate resources from countries’ contribution and partners is needed and should be part of the discussion of 2022 national budgets,” concluded Diop Ly, who is a health specialist with the African Development Bank and an advisor to the Senegal-based public health NGO, Speak-Up Africa. Potential lies to reduce market barriers to new medicines and fight fakes Andy Gray, senior lecturer in pharmacology at the University of KwaZulu-Natal in South Africa, said that AMA’s greatest potential lies “in the field of harmonisation of regulatory systems, which should reduce the barriers to market entry in Africa”. “The AMA is not intended to be a supranational regulator, and will not make decisions in the way the EMA does, but it could help in bringing national medicines regulatory authorities together, simplifying systems and reducing redundancy,” explained Gray. Over a quarter of the continent’s medicines are substandard or falsified, while only 2% are produced in Africa, according to AUDA. Through the harmonized regulatory framework, norms and standards, AMA will enable better access and equity to safe, quality medicine, medical products to African patients. This will also bring access to new and innovative technology for vaccines, medicine, medical devices, etc that will serve patients. The huge challenge of expanding universal health coverage – including health insurance – can also be advanced more systematically, with the support of new AMA structures – which should ease affordable access to medications, experts say. Proposed nearly a decade ago A continental medicine agency was first proposed a decade ago, and African Union member states adopted the AMA treaty almost three years ago. But the treaty could only be enforced once 15 AU member states had formally notified the AU Commission that they had ratified the treaty. This happened 30 days ago, when Cameroon became the 15th country to do so, thus setting in motion the formal establishment of the agency. The main aims of the AMA, as listed by the AU Development Agency (AUDA), are to: Support the growth of local pharmaceutical production Evaluate medical products to treat priority diseases identified by the AU Regularly inspect, coordinate and share information about products that are authorised for marketing. Coordinate reviews of clinical trial applications for vaccines and assess product dossiers such as bio-similars. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites. Collaborate with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs) to identify substandard and fake medical products Develop common standards and regulations, which will ensure that the continent’s legislation is harmonised. Responding to the medical crisis caused by COVID-19, the International Alliance of Patients’ Organizations (IAPO) helped to set up a lobby group, the African Medicines Agency Treaty Alliance (AMATA), to push for the speedier establishment of the agency. AMA ‘critically important’ says United States Meanwhile, Jessie Lapenn, the US Ambassador to the African Union, described the AMA as critical important to improving health security in Africa. “The AMA will be another critically important African institution that is part of the broader architecture that will be crucial for strengthening the continent’s health security,” Lapenn said at Thursday’s Africa Centres for Disease Control media briefing. “The US government and US private sector are very much looking forward to collaboration with AMA,” Lapenn added. Along with Cameroon, other countries to have both ratified the AMA and “deposited the instrument of ratification” at the AU (a letter from the head of state informing it of ratification) are predominantly west and north African, and/ Francophone nations, including: Algeria, Benin, Burkina Faso, Gabon, Guinea, Mali, Mauritius, Niger, Seychelles, and Sierra Leone. That may be due, in part, to the fact that the AU’s Special Envoy on the AMA is Michel Sidibé, Mali’s ex-Minister of Health. Now it will be up to southern, eastern and northern Africa to catch up – although Rwanda, Namibia and Zimbabwe have also been among the first to have ratified and deposited the treaty instrument. They were followed by Uganda, which signed the treaty on November 3. https://twitter.com/sabrinah_nati/status/1456617479430709249 Pharma groups welcome AMA’s creation Pharmaceutical companies have long complained about how complicated it is to get medicines approved in Africa and how long it takes – particularly in comparison to Europe, which processes applications via a central European Medicines Agency (EMA). A significant number of African countries’ national medicine regulatory authorities are under-resourced and lacking in expertise. Greg Perry, Assistant Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), welcomed the landmark moment where the treaty has now come into force, describing it as “one step closer to achieving a continent-wide regulatory agency”. “We look forward to the full implementation of the AMA, which will be a game-changer for all Africans to access safe, effective and quality medical products in a timely manner,” said Perry. -Updated on 8 November, 2021 Image Credits: James Oatway/IMF – Healthcare Focus , ©EC/ECHO/Anouk Delafortrie, LinkedIn. Pfizer Says New Anti-Viral Drug Combination Cuts Risks Of Serious COVID-19 By 89% 05/11/2021 Aishwarya Tendolkar Pfizer’s experimental pill works by inhibiting replication of SARS-CoV2 virus. Pfizer Friday announced that its experimental COVID-19 oral antiviral drug PAXLOVID™ reduced risks of hospitalization and death by 89% among patients who received the drug within the first three days of their illness. The company said it had stopped its Phase 2/3 trial on the drug owing to the success rate seen in an interim analysis of 1,219 adults enrolled in the study – who also had chronic health conditions placing them at higher risk of severe COVID. Pfizer is the second pharma firm, after Merck Sharp & Dohme (Merck), to announce highly promising results for an oral drug treatment that reduces serious COVID-19 illness – although the Pfizer results were even more stunning. PAXLOVID™ has the potential to eliminate up to nine out of ten hospitalizations, Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said in a press release. It’s a gamechanger,” Pfizer CEO Albert Bourla told @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” If approved for emergency use by the United States Food and Drug Administration (US FDA), PAXLOVID™ would become the first oral COVID antiviral of its kind. The novel treatment includes a newly- designed SARS-CoV-2-3CL protease inhibitor used in combination with a common anti-HIV drug, ritonavir. Bourla told CNBC that the filing for the drug is expected to be submitted before the U.S. Thanksgiving holiday on Nov. 25. “It’s a gamechanger,” Pfizer CEO Albert Bourla tells @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” https://t.co/IUYCAbZUu9 pic.twitter.com/QTFfJBizPs — CNBC (@CNBC) November 5, 2021 Pfizer’s results more impressive than Merck’s The Pfizer announcement follows Merck’s announcement last month that it’s new oral pill, molnupiravir, had reduced the risks of hospitalization and death by some 50% among people with mild or moderate COVID. The Merck pill, which was approved by UK regulators last week, introduces errors into the genetic code of the SARS-CoV2 virus that it targets, slowing virus replication. Pfizer’s reported results were even more impressive, however. Based on a primary analysis of interim data from 1,219 at-risk adults who were enrolled by September 29, 2021, only three people administered the drug within three days of sympton onset were hospitalized through day 28 of their illness, with no deaths. In the control group, 27 people were hospitalized, with seven subsequent deaths. When the company decided to stop recruiting more patients, their enrollment had reached 70 percent of the planned 3,000 patients across North and South America, Europe, Africa, and Asia. Pfizer drug is based upon a novel protease inhibitor, PF-07321332, that blocks the activity of the enzyme that the coronavirus needs to replicate. Co-administration of ritonavir means that protease inhibitor remains active in the body for longer periods of time to combat the virus. Treatment involves the administration of three PAXLOVID™ pills, twice a day, for five days. Pfizer says it will also ensure equitable access to new drug formulation While Merck’s molnupiravir pill is set to be licensed for generic production in most low- and middle-income countries, Pfizer said that it will offer PAXLOVID™ worldwide, through a tiered pricing approach – while maintaining control of its IP. Last week, Merck and the Medicines Patent Pool signed an agreement that paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell their treatment molnupiravir at discounted prices to more than 105 countries worldwide, once the drug receives approval by the World Health Organization. Pfizer, in contrast, said that its tiered pricing would be “based on the income level of each country to promote equity of access across the globe. “High and upper-middle income countries will pay more than lower income countries,” Pfizer said, adding that it had already entered into advance purchase agreements with “multiple countries and is in negotiations with several others” – without naming which. “Pfizer has also begun and will continue to invest up to approximately $1 billion to support the manufacturing and distribution of this investigational treatment, including exploring potential contract manufacturing options to help ensure access across low- and middle-income countries, pending regulatory authorization.” Image Credits: Wikimedia Commons, peterschreiber.media/Shutterstock . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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Fifty Countries Commit to ‘greening’ their healthcare systems at COP26 09/11/2021 Kerry Cullinan Solar panels provide electricity to Mulalika Health Clinic in Zambia. Fifty countries have committed to building sustainable, low-carbon and climate-resilient healthcare systems, and 14 of these have set net-zero carbon emission target dates from as early as 2030. This emerged from a health and climate change session at COP26, the United Nations climate conference in Glasgow, that was co-hosted by the World Health Organization (WHO). “As part of a green and resilient recovery from COVID-19, we need to recognise the role of health systems as emitters accounting for 4% to 5% of global emissions,” said Dr Rachel Levine, US Assistant Secretary in the Department of Health and Human Services. If the global health care sector were a country, it would be the fifth-largest greenhouse gas emitter on the planet, according to Health care’s climate footprint, a report produced by Health Care Without Harm. “These emissions are predicted to increase as health systems develop, and demographic changes lead to increasing healthcare demand,” said Levine, adding that the countries that had committed to building low carbon health systems were responsible for about one-third of all health sector emissions globally. The US has committed to decarbonizing the nation’s health systems by reducing greenhouse gas emissions in the federal health system, as well as the private sector via “incentives, guidance, technical assistance and regulatory approaches and partnerships”, Levine added. “The United States action on health system decarbonization is influential and critical. The US accounts for approximately 25% of the world’s health sector greenhouse gas emissions. This commitment to reducing greenhouse gases will also result in decreasing the negative health impacts of air pollution, such as premature death, heart disease, stroke, and more,” said Levine. Breaking: #COP26, over 50 countries have committed to decarbonize their #health systems a first ever COP presidency event on climate & health.Health sector is stepping up to decarbonize & calling global leaders to do the same!#ClimateEmergency #ClimatePrescription @HCWHGlobal pic.twitter.com/iwPhsdUJxW — Global Climate and Health Alliance (@GCHAlliance) November 9, 2021 Josh Karliner, International Director of Program and Strategy at Health Care Without Harm, said that “there is a growing global movement of hospitals and health systems” that were already reducing their carbon emissions. “There are more than 54 institutions in 21 countries representing more than 14,000 hospitals and health centres committed to race to zero,” said Karliner. “This is from Newcastle to New York. It’s from Sao Paulo to South Africa. It’s from Kerala to California.” Karliner explained: “We’re seeing hospitals and health systems taking action by investing in renewable energy by investing in zero-emission buildings and transport; by substituting anaesthetic gases with more sustainable alternatives; by implementing sustainable procurement programmes to purchase sustainably produced food, energy-efficient medical devices and lower carbon pharmaceuticals.” However, ‘greening’ health systems is a massive, expensive undertaking that requires many fundamental changes covering architecture, waste disposal, energy, and water. A flash flood in Fiji in 2018 Small island states struggle to make health services climate-resilient Dr Satyendra Prasad, Fiji’s permanent representative to the UN, told the meeting that his country struggled to keep health services running when faced with superstorms and other adverse weather events. “It is quite tragic when your doctors and nurses are being evacuated when they should be providing frontline services to people who have been injured and who need care,” said Prasad. “This conundrum is very tough, and it is a conundrum that exists for so many countries,” said Prasad, adding that Fiji is in the process of relocating health services to higher ground and equipping facilities with renewable energy to enable them to remain operational after major cyclones of flooding. “We losing fewer lives to extreme weather catastrophes. We are losing more lives to waterborne diseases and all the diseases that come following a major catastrophe such as flooding, and cyclone,” he added. Similarly, the Maldives has seen the emergence of vector-borne tropical diseases such as Dengue, which it didn’t use to have, said Aminath Shauna, Minister of Environment, Climate Change and Technology in the Maldives. “The Maldives is one of the most vulnerable island nations to climate change. We are experiencing things that we thought would happen towards the end of the century,” said Shauna. “Our coral reefs are dying. We are running out of fresh water. Our islands are eroding, and our islands are getting more frequently flooded, which poses a significant challenge to our public health system,” she added. To mitigate these risks, the Maldives has integrated climate risks into health policy, developed climate-sensitive disease programmes and is promoting climate-resilient healthcare facilities that are able to withstand climate events. It is also working to ensure that its essential services such as water, sanitation, waste management and electricity can still function during extreme weather events. “The Maldives health sector is also committed to initiating the greening of the health sector by adopting environment-friendly technologies and using energy-efficient services,” said Shauna. Finances for adaptation However, finances to make these changes are a challenge for countries like Fiji and the Maldives. Lack of finance has been a recurrent theme at COP26, with smaller countries with small carbon footprints appealing for reparations from large polluting countries to assist them to mitigate climate change. Former UK prime minister Gordon Brown and WHO Ambassador for Global Health Financing told the meeting that “you cannot cut investment in health at the expense of climate change – and you cannot cut investment in climate finance at the expense of health”. “We really have to recognise that we’re dealing with global public goods – the control of infectious diseases, a clean environment, clean air and a clean environment,” said Brown. “And we need to have a system of global burden-sharing where the richest countries that are responsible for the historic emissions and have the wealth and the capacity to pay, make good the funding that is necessary for mitigation and adaptation, and that includes the adaptation of healthcare systems, particularly in the poorest parts of the world,” said Brown. Despite the global commitment made at Paris COP to ensure $100 billion a year in financing to mitigate climate change by the end of this year, it looks like this target will only be reached in 2023. However, Brown stressed that if this target was not reached, it would deprive developing countries “of the opportunity not only to build coastal defences and renewable industries, but to build the healthcare systems that are necessary for resistance to droughts and famine, and also to pollution in the air”. .@WHO strongly welcomes commitments made at #COP26 by some countries to build health systems resilient to the impacts of the #ClimateCrisis, incl. extreme weather events, the increasing burden of diseases related to #airpollution and our warming planet. https://t.co/lDSceMsWlg pic.twitter.com/8dhOmL8QXM — Tedros Adhanom Ghebreyesus (@DrTedros) November 9, 2021 Addressing the meeting via a recorded message, WHO Director-General Dr Tedros Adhanom Ghebreyesus said that the changes the world needed to make to energy, transport and food systems to meet the Paris climate goals “would bring massive health gains”. He added that the WHO is committed to working with the countries that had committed to building greener health systems “for a healthier and more sustainable future”. Image Credits: UNDP/Karin Schermbrucker for Slingshot , World Meterological Organisation. Health Impacts of Climate Change Grab Eyeballs at COP26, But Lack of Finance Continues to be Major Issue 09/11/2021 Disha Shetty WHO Director-General Dr Tedros receiving an open letter about climate change, signed by health professionals from around the world and organized by Doctors for XR. GLASGOW – Conversations on the health impacts of the climate crisis have grown this year at COP26 – the United Nation’s annual climate conference, now in its 26th year. Experts hope that this increase in conversation will lead to greater awareness about the health crisis exacerbated by the climate crisis and lead to concrete action in the months and years ahead. Around 85% of countries now have a designated focal point for health and climate change in their ministries of health, according to the 2021 World Health Organization (WHO) health and climate change global survey report released on Monday. But countries report that a lack of funding, impact of COVID-19, and insufficient resource capacity are major barriers to progress. Many countries are unsupported and unprepared to deal with the health impacts of climate change, according to the survey. “We are here at COP26 to urge the world to better support countries in need, and to ensure that together we do a better job of protecting people from the biggest threat to human health we face today,” said Dr Maria Neira, WHO Director of Environment, Climate Change and Health. At the sidelines of the climate negotiations, the WHO held a day-long conference over the weekend focussed on the climate and health that was attended by high-level delegates. “We are used to talking about climate as an environmental challenge, an economic challenge, an equity challenge. But it is also one of the most urgent health challenges facing us all today,” said Julia Gillard, former Prime Minister of Australia and Chair of Wellcome Trust. The conference sought to highlight that while climate change affects health, the mitigation strategies will also automatically translate into health gains. “Health must become the beating heart of climate action”, said Jeni Miller, executive director of the Global Climate and Health Alliance. “Political leaders must prioritise health and social equity, emission reduction and impact mitigation over politics, profit and unproven technological fixes. The decisions made during COP26 will define the health and wellbeing of people all over the world for decades to come”. Dr. Maria Neira, Director of WHO Environment, Climate Change and Health Highlighting the health gains of clean air In the first week of the COP26 negotiations, WHO also co-hosted a panel discussion on both the health and climate gains of clean air that this reporter helped moderate. Given that air pollution alone kills around seven million people worldwide every year, any progress on this would save millions of lives annually. The event also came at a time when air pollution in India’s capital, Delhi, had reached lethal levels following last week’s celebration of the festival Diwali, during which people set off fire crackers. The densely populated Indo-Gangetic plain where Delhi is, is one of the world’s most polluted regions, and emerging research suggests the source of air pollution is local. Dr Neira said that the time for conversations was over, the evidence on air pollution is clear and it is time now to act. As many of the pollutants that cause air pollution also lead to a greenhouse effect, the WHO has made efforts to highlight the dual climate and health gains of improving air quality that disproportionately affects vulnerable groups like children and the elderly. Developing countries are pushing for climate finance and technology transfer at COP so that they have the support they need to clean their air but much of this also needs to happen at sub-national levels, especially at city-level, that will also require local action, highlighted Ani Dasgupta, President and CEO of World Resources Institute (WRI). Health not a part of text of negotiations It was clear although that while health is a part of the growing conversation, it is far from figuring in the main climate negotiations. A former negotiator elaborated that, given how bitter and exhausting climate negotiations are, adding health to the text might not be practical and that any reduction in global carbon emissions will automatically translate into health gains. At this year’s COP there is also a push to hold the rich countries accountable for the loss and damage being caused by the climate crisis in vulnerable nations. Public health crisis, even though directly caused or exacerbated by extreme climate events, aren’t part of these negotiations either. “I don’t see it coming up very directly into the loss and damage negotiations here because the negotiations are more about the overarching structures, not necessarily on a very particular theme,” said Sven Harmeling, the International Climate Policy Lead, from CARE and CAN Europe. He did add that it does factor in how many of the developing countries think about the damages being caused. WHO’s latest survey backs his view. It found that virtually all (94%) countries have incorporated health considerations in their nationally determined contributions (NDCs) to the Paris Agreement, voluntary pledges by the government to reduce their carbon emissions. Emissions from coal-burning power stations are causing air pollution that is affecting millions of people worldwide. Highlighting emissions from healthcare and silos Among the conversations at COP26 that centred on healthcare was also how to get the healthcare sector to reduce its own emissions. A 2019 report from Healthcare Without Harm based on 2014 data on carbon emissions suggests that globally 4.4% of carbon emissions are from the healthcare sector itself. The US health sector had the largest greenhouse gas emissions. Andrea Epstein, climate programme manager for Latin America at Healthcare Without Harm said that number is probably higher now that despite the region being a part of the developing world, there is a growing interest in decarbonizing the health systems. “The problem is of course the means of implementation. Not just the financing and the technology but also having the capacity for that. So while it is a challenge, the interest is there.” Members of the civil society organisations present at COP highlighted the silos that continued to exist in conversations around health, climate and food – all of which affect each other but are handled by different organisations. Disha Shetty is reporting from COP26 as a part of the 2021 Climate Change Media Partnership, a journalism fellowship organized by Internews’ Earth Journalism Network and the Stanley Center for Peace and Security. Follow her on Twitter @dishashetty20 Image Credits: WHO/Chris Black, Planetary Health Eastern Africa Hub. Pandemic Treaty Offers Opportunity to Repair Fault Lines in COVID-19 Response – and Address Equity 09/11/2021 Kerry Cullinan A nurse takes the temperature of a child suspected of COVID-19 symptoms in a Lebanese public health centre. An international pandemic treaty based on equity could be the antidote to current weaknesses and imbalances in the global response to COVID-19, according to a group of influential authors in a Lancet paper published on Tuesday. A number of the authors are associated with The Independent Panel for Pandemic Preparedness and Response chaired by Helen Clark and Ellen Sirleaf Johnson, which was set up to assess the World Health Organization’s (WHO) response to COVID-19. Based on a timeline developed by the panel that lays out the global COVID-19 response, the authors conclude that the International Health Regulations (IHR) are too weak, and the required country actions are too slow, to protect the world against pandemics. Revised after the 2005 Severe Acute Respiratory Syndrome (SARS) outbreak, the IHR focus on balancing disease notification and health risks with international trade and travel considerations. They specify when and how Member States should notify WHO of a local disease outbreak, and what actions WHO and States should take after that notification. The IHR are currently the only legally binding international instrument governing countries’ obligations to report and respond to pathogens that could result in cross-border disease outbreaks and potential public health emergencies. In their review, the authors identified a number of significant IHR weaknesses, including: constraints on WHO reporting publicly about national events with pandemic potential; the need for greater specificity on the information that countries need to share with WHO; and a streamlined process to facilitate WHO verification of events within 24 hours of the first signals of an outbreak being received. Special World Health Assembly The article comes a few weeks before global leaders meet at a World Health Assembly special session (29 November – 1 December) to consider adopting an “instrument or treaty” to address pandemic preparedness and response. “It’s clear: if a new, fast-spreading pathogen were to emerge next month, the current IHR regime would not protect people and trade as intended,” said Dr Sudhvir Singh, lead author on the paper and an advisor to the Independent Panel. “We suggest change to the IHR and a new treaty or another instrument that would result in more information shared faster, WHO able to investigate rapidly, all countries moving immediately to assess risk; and tools, like tests and vaccines, available to all who need them.” Georgetown University’s Dr Alexandra Phelan added that “COVID-19 has shown that the existing obligations under the IHR are insufficient for our interdependent and digital world.” “Our analysis demonstrates that collectively, countries urgently need to update our international system to respond to the potential rapid spread of a high impact respiratory pathogen,” said Phelan. “We have concrete suggestions for ways in which the IHR may be revised or amended, as well as the approach and issues that must be covered in any new legal framework, like a pandemic treaty.” Four reasons for a pandemic treaty The authors advance four reasons why a pandemic treaty “presents the opportunity to enact comprehensive reform in pandemic preparedness and response”. “First, a pandemic treaty centred on the principle of equity would be an important signal of international commitment to guard against the entrenchment of global division and injustice.” A pandemic treaty offers an opportunity to “develop and instil norms of equity, justice, and global public goods of pandemic preparedness and response”, they argue. “Second, a pandemic treaty could provide high-level complementarity to the IHR and any potential post-pandemic reforms and proactive multidisciplinary approaches to zoonotic risk,” they argue. Their third argument is that a treaty establishes greater accountability, outbreak support, and global access to vital public health information. Finally, a pandemic treaty could provide the opportunity to develop “a solid evidence base for non-pharmaceutical interventions” that might prevent the next outbreak from becoming a pandemic. “The upcoming Special Session of the World Health Assembly is a critical opportunity for Member States to move ahead with strengthening the IHR and to agree on a process for negotiating a pandemic treaty. We must not lose this opportunity to protect global public health and future generations,” said Phelan. At a recent event hosted by G2H2, civil society organisations expressed fear that a pandemic treaty was a distraction from the TRIPS waiver. But Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver. Kümmel added that amending the IHR also would take time to negotiate. And a key question here is: “would they be a game-changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” Image Credits: UNICEF . Obama Critical of China and Russia’s ‘Dangerous Lack of Urgency’ in Climate Change at COP26 08/11/2021 Raisa Santos Former US President Barack Obama speaking at COP26 Former US President Barack Obama openly criticized two of the world’s largest CO2 emitting countries – Russia and China, for their “dangerous lack of urgency” in discussing the pressing matters of climate change this past week during COP26. Both Chinese President Xi Jinping and Russian President Vladimir Putin failed to make an appearance with other global leaders at the 26th United Nations Climate Change Conference in Glasgow, which Obama found to be “particularly discouraging,” as he addressed a room of climate experts at the event on Monday. “We need advanced economies like the US and Europe leading on [the issue of climate change]. But we also need China and India, we need Russia, just as we need Indonesia and South Africa and Brazil leading on this issue. We can’t afford anybody to be on the sidelines.” Obama noted that while there has been some progress made in the six years since the Paris Agreement, the legally binding international treaty on climate change, the world still falls short of their commitment to limit global warming to well below 1.5 C. “Here in Glasgow we see the promise of further progress. What is also true is that collectively and individually, we are still falling short. We have not done nearly enough to address this crisis.” “We are going to have to do more and whether that happens or not to a large degree is going to depend on you,” said Obama, calling for collective action from young people and politicians alike to take climate change seriously. Twenty countries pledge to end public finance of international fossil fuel development Although most nations have failed to be ambitious in their climate goals in the past week of COP26, said Obama, significant accomplishments and hard-won commitments have been made during the climate conference. One such commitment was for high-income countries to help low- and middle-income countries move away from fossil fuels. Back in September, US President Joe Biden told the UN General Assembly that the US would provide more than $11 billion in climate aid annually by 2024 to developing nations vulnerable to extreme weather and rising temperatures. In addition, the US and 20 other countries have pledged to stop publicly financing international fossil fuel development, with limited exceptions. “We will end new public direct support for the international unabated fossil fuel energy sector by the end of 2022,” the declaration read. The 20 countries that signed the pledge include Denmark, Italy, Finland, Costa Rica, Ethiopia, Gambia, New Zealand and the Marshall Islands, plus five development institutions including the European Investment Bank and the East African Development Bank. This deal does go further than a pledge made earlier in the year by the G20 to end international financing of coal-based power generation outside their own countries. However, this declaration does not include major Asian countries responsible for financing a majority of overseas fossil fuel projects. Climate change cannot be a partisan issue While collective action in fighting climate change requires international cooperation, Obama noted the geopolitical tensions that have arisen as a result of the pandemic, but called for the world to step up despite these tensions. “Climate change can’t be seen anywhere in the world as just an opportunity to score political points.” “Saving the planet isn’t a partisan issue. Nature, physics, science, do not care about party affiliation,” he added. Climate change, in the US particularly, has become a partisan issue, causing what Obama referred to as a “lack of leadership on America’s part” and the “open hostility towards climate science at the very top of the [US] federal government” that resulted from former President Donald Trump’s four years in office. Obama also pointed out that the lack of a stable congressional majority has prevented him and current President Joe Biden from taking an even stronger stance on climate change. However, Obama remain sconfident that Biden’s Build Back Better Framework, which would set the US on course to meet its climate goals, would be passed in coming weeks. The legislation, once approved by the US Congress, would devote at least US $1.7 trillion dollars to reduce greenhouse gas emissions by over a billion metric tons by the end of 2030. Young people have more at stake in the fight against climate change Greta Thunberg addresses climate strikers at Civic Center Park in Denver, Colorado. Thunberg is one climate activist Obama praised for inspiring millions in the fight against climate change. Though Obama noted that at times, he was “doubtful that humanity can get its act together before it’s too late”, this cynicism was countered by the prevailing efforts of young climate activists around the world. Addressing all the young people, who Obama said, had “more stake in this fight than anybody else,” he said: “I want you to stay angry. I want you to stay frustrated. Channel that anger, harness that frustration.” “Because that’s what’s required to meet this challenge. Solving a problem this big and this important has never happened all at once.” Image Credits: COP26, Andy Bosselman, Streetsblog Denver/Flickr. Children’s Health Hit Hardest by Climate Change – but Cleaner Air, Greener Cities and Healthier Foods Can Create Cascade of Benefits 07/11/2021 Elaine Ruth Fletcher Rosamund Kissi-Debrah, mother of 11-year Ella, whose 2013 death from severe asthma was the first to be recognized by a court as caused by air pollution. Greening cities, investing in urban bike lanes rather than new roads, and making plant-based foods cheaper and easier to access than ultra-processed foods. This is a doctor’s prescription for a healthier planet. As climate negotiators at Glasgow’s COP26 conference remain locked in debate over the big-picture ambition of targets for global CO2 emissions reductions, and how to finance them, health advocates are trying to raise the profile of climate policies that would yield far-reaching knock-on benefits to the health of almost everyone on earth – but particularly for children, women and people living in some the poorest nations of the world. “We have sacrificed children all around the world to air pollution,” said Rosamund Kissi-Debrah, noting that some 500,000 children a year die from air pollution. Kissi-Debrah was speaking at the COP26 “Triple Win Scenario” event on Friday, co-sponsored by the WHO and the World Resources Institute. Kissi-Debrah’s 11-year-old girl daughter, Ella, was one of those victims. But her death from severe asthma in 2013 set a precedent: it was the first to be recognised by a court anywhere in the world as air-pollution induced. "We have sacrificed children all around the world to #airpollution" – caused by the same sources of #climatechange: Rosamund Kissi-Debrah, mother of 9-year-old Ella at #COP26. Ella's death from #dirtyair was the first to be recognized by a court in 2020: https://t.co/mf8LyLAsmb — Health Policy Watch – Global Health News Reporting (@HealthPolicyW) November 5, 2021 Like many Londoners, and many more urban dwellers in low- and middle-income cities around the world, Ella had lived in a heavily trafficked and heavily polluted neighbourhood. Shifting travel to greener modes, greening cities with more trees and making cities more walkable are among the climate strategies that health forces are advocating, and could all make a difference to the next generation. “Be serious, stop burning fossil fuels because those fossil fuels go into the air and into my lungs and yours. When you think about the planet, think about a couple of little, pink lungs,” said Dr Maria Neira, Director of the Department of Public Health, Climate & Environment, at the event. She noted that some 90% of the world’s population is exposed to unhealthy air pollution levels, leading to seven million deaths a year. Children among those worst affected The COVID-19 pandemic and climate change have created a perfect storm for increased malnutrition, child wasting and stunting, and maternal anaemia in parts of Africa. The fact that children are among those worst affected by climate change is underscored by a new review of the knowledge about climate change on child health, published by the Lancet on Sunday. “Present and future generations of children bear and will continue to bear an unacceptably high disease burden from climate change,” states the review’s authors, a group of Swedish experts from the Karolinksa Institute and elsewhere. “Through its far-reaching impact on all parts of society, climate change will challenge the very essence of children’s rights to survival, good health, wellbeing, education, and nutrition as enshrined by the Convention on the Rights of the Child and emphasised in the UN Sustainable Development Goals,” they note. “Climate change threatens to exaggerate the vulnerabilities of children and other populations at risk and could substantially hamper future progress and possibly even reverse the improvements made in child survival and wellbeing during recent decades,” concludes the review, suggesting that climate change needs to be better integrated into the SDG goals that cover children’s health overall.” Glasgow moment for health advocates Woman receives food assistance after widespread flooding the Horn of Africa and East Africa in 2020, linked by meterologists to climate change. But air pollution is only one of a range of ways in which our addiction to fossil fuels is delivering a double whammy to health – and children’s health in particular. Other, even more direct impacts include deaths and illness from extreme heat, storms, flooding, fires and drought. In addition, reduced food production capacity, an expanding geographic range for many infectious diseases, and increasing risk of new animal-borne diseases leaping from the wild to burgeoning cities – as SARS-CoV2 did – are imminent threats too. Given the rapid pace of climate change, “it won’t be long before the entire population of the world is affected, directly or indirectly,” said Julia Gillard, chair of the board of the UK-based philanthropy, Wellcome Trust and former Australian Prime Minister. Gillard was speaking at the COP26 “Global Conference on Health and Climate Change,” co-hosted by the World Health Organization (WHO) in Glasgow on Saturday. At the conference, co-sponsored by Wellcome, three UK-based universities and civil society groups, speakers warned of the burgeoning global health crisis that would result from inaction on climate change. “We are used to talking about climate as an environmental challenge, an economic challenge, an equity challenge. But it is also one of the most urgent health challenges facing us all today,” said Gillard. #Breaking #COP26: Health and Climate Experts Warn of Climate-Related Health Crisis https://t.co/kLWSb4Ilkc @JuliaGillard @DrTedros @WHO @Centre @JeniMiller @GCUclimatejust @jafryt @DrMariaNeira — Global Climate and Health Alliance (@GCHAlliance) November 6, 2021 Integrated policies not just global goals Sir Andy Haines, Professor of Environmental Change and Public Health at the London School of Hygiene and Tropical Medicine, speaking at the COP26 Climate and Health Summit. Tackling the root sources of climate change more rapidly can generate immediate savings for health systems and societies. But that will require not only big picture targets but a complete rethinking of policies, regulations, taxes and finance incentives at national and local levels, experts at the conference pointed out. “We need people to work together for integrated solutions,” said Professor Andy Haines of the London School of Hygiene and Tropical Medicine, who has written extensively on the planetary limits of not only temperature but also water, agricultural and forest ecosystems, which humankind needs to preserve to survive and thrive. Integration means recognising, for instance, that “the minister of transport is probably more a minister of health than the minister of health”, said Richard Smith, president of the UK Health Alliance on Climate Change. Commitment to ending financing for fossil fuel Twenty-six countries, including the US, UK, Canada and Italy, as well as the European Investment Bank and the French development agency, Agence Française de Développement, signed a commitment late last week to “end new direct public support for the international unabated fossil fuel energy sector by the end of 2022, except in limited and clearly defined circumstances that are consistent with a 1.5°C warming limit and the goals of the Paris Agreement”. The signatories also committed to prioritising their support “fully towards the clean energy transition”, using their resources to “enhance what can be delivered by the private sector”. They also commit to trying to persuade other governments, export credit agencies and public finance institutions to implement similar commitments into COP27 and beyond. According to WHO climate scientist Dr Diarmid Campell-Lendrum, $5.9 trillion is spent on direct and indirect subsidies to the fossil fuel industry each year. “We need to stop spending money on the wrong things and start spending it on the right things,” said Campbell-Lendrum, who cycled 1,600 km from Geneva to the Glasgow summit to drive home his point. He bore with him a letter calling for more climate action, signed by some 300 organisations, representing some 45 million health care professionals around the world. In London, Campbell-Lendrum was met by a raft of other climate cycle enthusiasts who continued the relay, getting the letter to Glasgow, where it was delivered to the COP26 leadership. https://twitter.com/i/status/1454817969276690436 Image Credits: Christine Olson/Flickr, IFRC, Paul Chappells. The African Medicines Agency Countdown 05/11/2021 Editorial team Thirty-nine of the African Union’s 55 member states have now signed and/or ratified the African Medicines Agency Treaty, as of 6 July 2024, with Kenya, the Democratic Republic of Congo and Cape Verde amongst the latest to swing behind the treaty. As the countdown for other nations to sign continues, Health Policy Watch is tracking progress on our AMA Countdown, website developed in collaboration with the African Medicines Agency Treaty Alliance. Here you can find the latest data on who has signed the treaty, ratified the treaty – and who is yet to sign – as well as links to sources and resources related to the African Medicines Agency Treaty process: Multimedia available for download: Find up-to-date infographics describing what countries have signed, signed and ratified, and signed, ratified and deposited the AMA treaty – in .png and interactive formats available for embed or download. African Union FAQs on the AMA Treaty Click to access 41269-doc-AMA_FAQs_rev.pdf Official African Union infographic repository Multilingual links to the AMA Treaty: The AMA Treaty in English: The AMA Treaty in French: The AMA Treaty in Arabic: The AMA Treaty in Portuguese: African Medicines Agency Treaty Alliance: AMATA joint statement, 5 November 2021, at the time that the AMA Treaty came into force. Breaking: Majority of African Countries Have Now Signed African Medicines Agency Treaty, Enabling Better Access to Newer, Safer Medicines 05/11/2021 Kerry Cullinan & Elaine Ruth Fletcher Pharmacy at Zouan health centre, Cote d’Ivoire; creation of an African Medicines Agency is intended to streamline regulatory approvals, improving quality and availability of medicines. Signatories to the new African Medicines Agency Treaty have now reached 28 countries – more than half of the African Union’s 55 member states – with the balance tipping as Uganda signed the treaty instrument last week. On Friday, 5 November, after more than a decade of preparations, the African Medicine Agency (AMA) treaty also came into force officially – clearing the way for the AMA to begin operations as a formal entity. And support for the treaty seemed to be picking up momentum with Cote d’Ivoire also signing the treaty on 29 October just ahead of Uganda’s signature on 3 November. See all the data here on our special website: African Medicines Agency Countdown, where we will be tracking all the latest developments in stories and interactive infographics. Despite the building support for the AMA, it will take more time, money and most of all – signatories from more of Africa’s powerhouse nations – to ensure that the new AMA entity can fulfill its mandate to ensure more rapid access to safer, newer and higher quality medicines across the continent. South Africa, Nigeria, Kenya and Ethiopia are among the 27 AU member states that have yet to even sign, yet alone ratify, the treaty document, which was first approved by the African Union in 2019. But with the AMA treaty coming into full force, exactly one month after the first 15 countries ratified and deposited the treaty instrument, no one is losing time. An AU meeting, set for February 2022, will select a country to host the new AMA headquarter and operations. Following that, formal structures will have to be set up and money raised to support its many crucial tasks. While a long road remains, AMA special envoy, Michel Sidibé said that the treaty’s entry into force is a ‘historic moment’. Historic moment today with the entry into force of the African Medicines Agency treaty. Bravo to the member states! We are grateful to President @AUC_MoussaFaki for his inspirational leadership and thank @AmiraDSA, @NEPAD_Mayaki, @DrTedros and all partners for their support. pic.twitter.com/a9IFitbFWz — Michel Sidibé (@MichelSidibe) November 5, 2021 COVID pandemic has sharpened the need for a continent-wide medicines agency The African Medicines Agency Treaty Alliance (AMATA), a coalition of patient civil society groups, academic institutions and industry, congratulated the first 15 African countries to ratify and deposit the treaty. AMATA called upon all other AU member states to quickly follow suit. Some 28 countries have so far signed the treaty, the majority in western Africa. Among those signatories, 10 have yet to ratify the treaty and three have still to deposit their ratifications with the African Union. The COVID-19 pandemic has sharpened the need for a continental agency that is able to fast-track approval for crucial vaccines and other medical products, AMATA said in its satement Friday: “COVID-19 has demonstrated that health security will only be achieved through concerted efforts and cross-border collaboration. “We call on all AU Heads of State to seize this historic opportunity to have one regulatory affairs oversight across the continent to enhance national, regional and continental regulation of medical products and oversee rapid and effective market authorization of safe, quality, effective and accessible medical products, for the good of all African people.” AMATA also called on the AMA Governing Board to rapidly move to put into place: A solid governance structure; Robust regulatory infrastructures; Adequate financial and human resources. AMATA also asked that the AMA governing board “recognise patients as key partners in the management structures and development of the agency”. Need for more AMA treaty signatories and quick operationalization Dr Maïmouna Diop Ly , AMATA board member AMATA executive board member Dr Maïmouna Diop Ly told Health Policy Watch that three critical tasks lay ahead in order for the agency to be successful. “There is a need to ensure that a critical number of countries sign the treaty to enable a quick operationalization of AMA,” said Diop Ly. “The statutory organs – the conference of state parties, governing board, secretariat and technical committees – should be put in place to ensure its functionality,” she added. “Finally, the allocation of adequate resources from countries’ contribution and partners is needed and should be part of the discussion of 2022 national budgets,” concluded Diop Ly, who is a health specialist with the African Development Bank and an advisor to the Senegal-based public health NGO, Speak-Up Africa. Potential lies to reduce market barriers to new medicines and fight fakes Andy Gray, senior lecturer in pharmacology at the University of KwaZulu-Natal in South Africa, said that AMA’s greatest potential lies “in the field of harmonisation of regulatory systems, which should reduce the barriers to market entry in Africa”. “The AMA is not intended to be a supranational regulator, and will not make decisions in the way the EMA does, but it could help in bringing national medicines regulatory authorities together, simplifying systems and reducing redundancy,” explained Gray. Over a quarter of the continent’s medicines are substandard or falsified, while only 2% are produced in Africa, according to AUDA. Through the harmonized regulatory framework, norms and standards, AMA will enable better access and equity to safe, quality medicine, medical products to African patients. This will also bring access to new and innovative technology for vaccines, medicine, medical devices, etc that will serve patients. The huge challenge of expanding universal health coverage – including health insurance – can also be advanced more systematically, with the support of new AMA structures – which should ease affordable access to medications, experts say. Proposed nearly a decade ago A continental medicine agency was first proposed a decade ago, and African Union member states adopted the AMA treaty almost three years ago. But the treaty could only be enforced once 15 AU member states had formally notified the AU Commission that they had ratified the treaty. This happened 30 days ago, when Cameroon became the 15th country to do so, thus setting in motion the formal establishment of the agency. The main aims of the AMA, as listed by the AU Development Agency (AUDA), are to: Support the growth of local pharmaceutical production Evaluate medical products to treat priority diseases identified by the AU Regularly inspect, coordinate and share information about products that are authorised for marketing. Coordinate reviews of clinical trial applications for vaccines and assess product dossiers such as bio-similars. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites. Collaborate with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs) to identify substandard and fake medical products Develop common standards and regulations, which will ensure that the continent’s legislation is harmonised. Responding to the medical crisis caused by COVID-19, the International Alliance of Patients’ Organizations (IAPO) helped to set up a lobby group, the African Medicines Agency Treaty Alliance (AMATA), to push for the speedier establishment of the agency. AMA ‘critically important’ says United States Meanwhile, Jessie Lapenn, the US Ambassador to the African Union, described the AMA as critical important to improving health security in Africa. “The AMA will be another critically important African institution that is part of the broader architecture that will be crucial for strengthening the continent’s health security,” Lapenn said at Thursday’s Africa Centres for Disease Control media briefing. “The US government and US private sector are very much looking forward to collaboration with AMA,” Lapenn added. Along with Cameroon, other countries to have both ratified the AMA and “deposited the instrument of ratification” at the AU (a letter from the head of state informing it of ratification) are predominantly west and north African, and/ Francophone nations, including: Algeria, Benin, Burkina Faso, Gabon, Guinea, Mali, Mauritius, Niger, Seychelles, and Sierra Leone. That may be due, in part, to the fact that the AU’s Special Envoy on the AMA is Michel Sidibé, Mali’s ex-Minister of Health. Now it will be up to southern, eastern and northern Africa to catch up – although Rwanda, Namibia and Zimbabwe have also been among the first to have ratified and deposited the treaty instrument. They were followed by Uganda, which signed the treaty on November 3. https://twitter.com/sabrinah_nati/status/1456617479430709249 Pharma groups welcome AMA’s creation Pharmaceutical companies have long complained about how complicated it is to get medicines approved in Africa and how long it takes – particularly in comparison to Europe, which processes applications via a central European Medicines Agency (EMA). A significant number of African countries’ national medicine regulatory authorities are under-resourced and lacking in expertise. Greg Perry, Assistant Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), welcomed the landmark moment where the treaty has now come into force, describing it as “one step closer to achieving a continent-wide regulatory agency”. “We look forward to the full implementation of the AMA, which will be a game-changer for all Africans to access safe, effective and quality medical products in a timely manner,” said Perry. -Updated on 8 November, 2021 Image Credits: James Oatway/IMF – Healthcare Focus , ©EC/ECHO/Anouk Delafortrie, LinkedIn. Pfizer Says New Anti-Viral Drug Combination Cuts Risks Of Serious COVID-19 By 89% 05/11/2021 Aishwarya Tendolkar Pfizer’s experimental pill works by inhibiting replication of SARS-CoV2 virus. Pfizer Friday announced that its experimental COVID-19 oral antiviral drug PAXLOVID™ reduced risks of hospitalization and death by 89% among patients who received the drug within the first three days of their illness. The company said it had stopped its Phase 2/3 trial on the drug owing to the success rate seen in an interim analysis of 1,219 adults enrolled in the study – who also had chronic health conditions placing them at higher risk of severe COVID. Pfizer is the second pharma firm, after Merck Sharp & Dohme (Merck), to announce highly promising results for an oral drug treatment that reduces serious COVID-19 illness – although the Pfizer results were even more stunning. PAXLOVID™ has the potential to eliminate up to nine out of ten hospitalizations, Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said in a press release. It’s a gamechanger,” Pfizer CEO Albert Bourla told @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” If approved for emergency use by the United States Food and Drug Administration (US FDA), PAXLOVID™ would become the first oral COVID antiviral of its kind. The novel treatment includes a newly- designed SARS-CoV-2-3CL protease inhibitor used in combination with a common anti-HIV drug, ritonavir. Bourla told CNBC that the filing for the drug is expected to be submitted before the U.S. Thanksgiving holiday on Nov. 25. “It’s a gamechanger,” Pfizer CEO Albert Bourla tells @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” https://t.co/IUYCAbZUu9 pic.twitter.com/QTFfJBizPs — CNBC (@CNBC) November 5, 2021 Pfizer’s results more impressive than Merck’s The Pfizer announcement follows Merck’s announcement last month that it’s new oral pill, molnupiravir, had reduced the risks of hospitalization and death by some 50% among people with mild or moderate COVID. The Merck pill, which was approved by UK regulators last week, introduces errors into the genetic code of the SARS-CoV2 virus that it targets, slowing virus replication. Pfizer’s reported results were even more impressive, however. Based on a primary analysis of interim data from 1,219 at-risk adults who were enrolled by September 29, 2021, only three people administered the drug within three days of sympton onset were hospitalized through day 28 of their illness, with no deaths. In the control group, 27 people were hospitalized, with seven subsequent deaths. When the company decided to stop recruiting more patients, their enrollment had reached 70 percent of the planned 3,000 patients across North and South America, Europe, Africa, and Asia. Pfizer drug is based upon a novel protease inhibitor, PF-07321332, that blocks the activity of the enzyme that the coronavirus needs to replicate. Co-administration of ritonavir means that protease inhibitor remains active in the body for longer periods of time to combat the virus. Treatment involves the administration of three PAXLOVID™ pills, twice a day, for five days. Pfizer says it will also ensure equitable access to new drug formulation While Merck’s molnupiravir pill is set to be licensed for generic production in most low- and middle-income countries, Pfizer said that it will offer PAXLOVID™ worldwide, through a tiered pricing approach – while maintaining control of its IP. Last week, Merck and the Medicines Patent Pool signed an agreement that paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell their treatment molnupiravir at discounted prices to more than 105 countries worldwide, once the drug receives approval by the World Health Organization. Pfizer, in contrast, said that its tiered pricing would be “based on the income level of each country to promote equity of access across the globe. “High and upper-middle income countries will pay more than lower income countries,” Pfizer said, adding that it had already entered into advance purchase agreements with “multiple countries and is in negotiations with several others” – without naming which. “Pfizer has also begun and will continue to invest up to approximately $1 billion to support the manufacturing and distribution of this investigational treatment, including exploring potential contract manufacturing options to help ensure access across low- and middle-income countries, pending regulatory authorization.” Image Credits: Wikimedia Commons, peterschreiber.media/Shutterstock . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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Health Impacts of Climate Change Grab Eyeballs at COP26, But Lack of Finance Continues to be Major Issue 09/11/2021 Disha Shetty WHO Director-General Dr Tedros receiving an open letter about climate change, signed by health professionals from around the world and organized by Doctors for XR. GLASGOW – Conversations on the health impacts of the climate crisis have grown this year at COP26 – the United Nation’s annual climate conference, now in its 26th year. Experts hope that this increase in conversation will lead to greater awareness about the health crisis exacerbated by the climate crisis and lead to concrete action in the months and years ahead. Around 85% of countries now have a designated focal point for health and climate change in their ministries of health, according to the 2021 World Health Organization (WHO) health and climate change global survey report released on Monday. But countries report that a lack of funding, impact of COVID-19, and insufficient resource capacity are major barriers to progress. Many countries are unsupported and unprepared to deal with the health impacts of climate change, according to the survey. “We are here at COP26 to urge the world to better support countries in need, and to ensure that together we do a better job of protecting people from the biggest threat to human health we face today,” said Dr Maria Neira, WHO Director of Environment, Climate Change and Health. At the sidelines of the climate negotiations, the WHO held a day-long conference over the weekend focussed on the climate and health that was attended by high-level delegates. “We are used to talking about climate as an environmental challenge, an economic challenge, an equity challenge. But it is also one of the most urgent health challenges facing us all today,” said Julia Gillard, former Prime Minister of Australia and Chair of Wellcome Trust. The conference sought to highlight that while climate change affects health, the mitigation strategies will also automatically translate into health gains. “Health must become the beating heart of climate action”, said Jeni Miller, executive director of the Global Climate and Health Alliance. “Political leaders must prioritise health and social equity, emission reduction and impact mitigation over politics, profit and unproven technological fixes. The decisions made during COP26 will define the health and wellbeing of people all over the world for decades to come”. Dr. Maria Neira, Director of WHO Environment, Climate Change and Health Highlighting the health gains of clean air In the first week of the COP26 negotiations, WHO also co-hosted a panel discussion on both the health and climate gains of clean air that this reporter helped moderate. Given that air pollution alone kills around seven million people worldwide every year, any progress on this would save millions of lives annually. The event also came at a time when air pollution in India’s capital, Delhi, had reached lethal levels following last week’s celebration of the festival Diwali, during which people set off fire crackers. The densely populated Indo-Gangetic plain where Delhi is, is one of the world’s most polluted regions, and emerging research suggests the source of air pollution is local. Dr Neira said that the time for conversations was over, the evidence on air pollution is clear and it is time now to act. As many of the pollutants that cause air pollution also lead to a greenhouse effect, the WHO has made efforts to highlight the dual climate and health gains of improving air quality that disproportionately affects vulnerable groups like children and the elderly. Developing countries are pushing for climate finance and technology transfer at COP so that they have the support they need to clean their air but much of this also needs to happen at sub-national levels, especially at city-level, that will also require local action, highlighted Ani Dasgupta, President and CEO of World Resources Institute (WRI). Health not a part of text of negotiations It was clear although that while health is a part of the growing conversation, it is far from figuring in the main climate negotiations. A former negotiator elaborated that, given how bitter and exhausting climate negotiations are, adding health to the text might not be practical and that any reduction in global carbon emissions will automatically translate into health gains. At this year’s COP there is also a push to hold the rich countries accountable for the loss and damage being caused by the climate crisis in vulnerable nations. Public health crisis, even though directly caused or exacerbated by extreme climate events, aren’t part of these negotiations either. “I don’t see it coming up very directly into the loss and damage negotiations here because the negotiations are more about the overarching structures, not necessarily on a very particular theme,” said Sven Harmeling, the International Climate Policy Lead, from CARE and CAN Europe. He did add that it does factor in how many of the developing countries think about the damages being caused. WHO’s latest survey backs his view. It found that virtually all (94%) countries have incorporated health considerations in their nationally determined contributions (NDCs) to the Paris Agreement, voluntary pledges by the government to reduce their carbon emissions. Emissions from coal-burning power stations are causing air pollution that is affecting millions of people worldwide. Highlighting emissions from healthcare and silos Among the conversations at COP26 that centred on healthcare was also how to get the healthcare sector to reduce its own emissions. A 2019 report from Healthcare Without Harm based on 2014 data on carbon emissions suggests that globally 4.4% of carbon emissions are from the healthcare sector itself. The US health sector had the largest greenhouse gas emissions. Andrea Epstein, climate programme manager for Latin America at Healthcare Without Harm said that number is probably higher now that despite the region being a part of the developing world, there is a growing interest in decarbonizing the health systems. “The problem is of course the means of implementation. Not just the financing and the technology but also having the capacity for that. So while it is a challenge, the interest is there.” Members of the civil society organisations present at COP highlighted the silos that continued to exist in conversations around health, climate and food – all of which affect each other but are handled by different organisations. Disha Shetty is reporting from COP26 as a part of the 2021 Climate Change Media Partnership, a journalism fellowship organized by Internews’ Earth Journalism Network and the Stanley Center for Peace and Security. Follow her on Twitter @dishashetty20 Image Credits: WHO/Chris Black, Planetary Health Eastern Africa Hub. Pandemic Treaty Offers Opportunity to Repair Fault Lines in COVID-19 Response – and Address Equity 09/11/2021 Kerry Cullinan A nurse takes the temperature of a child suspected of COVID-19 symptoms in a Lebanese public health centre. An international pandemic treaty based on equity could be the antidote to current weaknesses and imbalances in the global response to COVID-19, according to a group of influential authors in a Lancet paper published on Tuesday. A number of the authors are associated with The Independent Panel for Pandemic Preparedness and Response chaired by Helen Clark and Ellen Sirleaf Johnson, which was set up to assess the World Health Organization’s (WHO) response to COVID-19. Based on a timeline developed by the panel that lays out the global COVID-19 response, the authors conclude that the International Health Regulations (IHR) are too weak, and the required country actions are too slow, to protect the world against pandemics. Revised after the 2005 Severe Acute Respiratory Syndrome (SARS) outbreak, the IHR focus on balancing disease notification and health risks with international trade and travel considerations. They specify when and how Member States should notify WHO of a local disease outbreak, and what actions WHO and States should take after that notification. The IHR are currently the only legally binding international instrument governing countries’ obligations to report and respond to pathogens that could result in cross-border disease outbreaks and potential public health emergencies. In their review, the authors identified a number of significant IHR weaknesses, including: constraints on WHO reporting publicly about national events with pandemic potential; the need for greater specificity on the information that countries need to share with WHO; and a streamlined process to facilitate WHO verification of events within 24 hours of the first signals of an outbreak being received. Special World Health Assembly The article comes a few weeks before global leaders meet at a World Health Assembly special session (29 November – 1 December) to consider adopting an “instrument or treaty” to address pandemic preparedness and response. “It’s clear: if a new, fast-spreading pathogen were to emerge next month, the current IHR regime would not protect people and trade as intended,” said Dr Sudhvir Singh, lead author on the paper and an advisor to the Independent Panel. “We suggest change to the IHR and a new treaty or another instrument that would result in more information shared faster, WHO able to investigate rapidly, all countries moving immediately to assess risk; and tools, like tests and vaccines, available to all who need them.” Georgetown University’s Dr Alexandra Phelan added that “COVID-19 has shown that the existing obligations under the IHR are insufficient for our interdependent and digital world.” “Our analysis demonstrates that collectively, countries urgently need to update our international system to respond to the potential rapid spread of a high impact respiratory pathogen,” said Phelan. “We have concrete suggestions for ways in which the IHR may be revised or amended, as well as the approach and issues that must be covered in any new legal framework, like a pandemic treaty.” Four reasons for a pandemic treaty The authors advance four reasons why a pandemic treaty “presents the opportunity to enact comprehensive reform in pandemic preparedness and response”. “First, a pandemic treaty centred on the principle of equity would be an important signal of international commitment to guard against the entrenchment of global division and injustice.” A pandemic treaty offers an opportunity to “develop and instil norms of equity, justice, and global public goods of pandemic preparedness and response”, they argue. “Second, a pandemic treaty could provide high-level complementarity to the IHR and any potential post-pandemic reforms and proactive multidisciplinary approaches to zoonotic risk,” they argue. Their third argument is that a treaty establishes greater accountability, outbreak support, and global access to vital public health information. Finally, a pandemic treaty could provide the opportunity to develop “a solid evidence base for non-pharmaceutical interventions” that might prevent the next outbreak from becoming a pandemic. “The upcoming Special Session of the World Health Assembly is a critical opportunity for Member States to move ahead with strengthening the IHR and to agree on a process for negotiating a pandemic treaty. We must not lose this opportunity to protect global public health and future generations,” said Phelan. At a recent event hosted by G2H2, civil society organisations expressed fear that a pandemic treaty was a distraction from the TRIPS waiver. But Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver. Kümmel added that amending the IHR also would take time to negotiate. And a key question here is: “would they be a game-changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” Image Credits: UNICEF . Obama Critical of China and Russia’s ‘Dangerous Lack of Urgency’ in Climate Change at COP26 08/11/2021 Raisa Santos Former US President Barack Obama speaking at COP26 Former US President Barack Obama openly criticized two of the world’s largest CO2 emitting countries – Russia and China, for their “dangerous lack of urgency” in discussing the pressing matters of climate change this past week during COP26. Both Chinese President Xi Jinping and Russian President Vladimir Putin failed to make an appearance with other global leaders at the 26th United Nations Climate Change Conference in Glasgow, which Obama found to be “particularly discouraging,” as he addressed a room of climate experts at the event on Monday. “We need advanced economies like the US and Europe leading on [the issue of climate change]. But we also need China and India, we need Russia, just as we need Indonesia and South Africa and Brazil leading on this issue. We can’t afford anybody to be on the sidelines.” Obama noted that while there has been some progress made in the six years since the Paris Agreement, the legally binding international treaty on climate change, the world still falls short of their commitment to limit global warming to well below 1.5 C. “Here in Glasgow we see the promise of further progress. What is also true is that collectively and individually, we are still falling short. We have not done nearly enough to address this crisis.” “We are going to have to do more and whether that happens or not to a large degree is going to depend on you,” said Obama, calling for collective action from young people and politicians alike to take climate change seriously. Twenty countries pledge to end public finance of international fossil fuel development Although most nations have failed to be ambitious in their climate goals in the past week of COP26, said Obama, significant accomplishments and hard-won commitments have been made during the climate conference. One such commitment was for high-income countries to help low- and middle-income countries move away from fossil fuels. Back in September, US President Joe Biden told the UN General Assembly that the US would provide more than $11 billion in climate aid annually by 2024 to developing nations vulnerable to extreme weather and rising temperatures. In addition, the US and 20 other countries have pledged to stop publicly financing international fossil fuel development, with limited exceptions. “We will end new public direct support for the international unabated fossil fuel energy sector by the end of 2022,” the declaration read. The 20 countries that signed the pledge include Denmark, Italy, Finland, Costa Rica, Ethiopia, Gambia, New Zealand and the Marshall Islands, plus five development institutions including the European Investment Bank and the East African Development Bank. This deal does go further than a pledge made earlier in the year by the G20 to end international financing of coal-based power generation outside their own countries. However, this declaration does not include major Asian countries responsible for financing a majority of overseas fossil fuel projects. Climate change cannot be a partisan issue While collective action in fighting climate change requires international cooperation, Obama noted the geopolitical tensions that have arisen as a result of the pandemic, but called for the world to step up despite these tensions. “Climate change can’t be seen anywhere in the world as just an opportunity to score political points.” “Saving the planet isn’t a partisan issue. Nature, physics, science, do not care about party affiliation,” he added. Climate change, in the US particularly, has become a partisan issue, causing what Obama referred to as a “lack of leadership on America’s part” and the “open hostility towards climate science at the very top of the [US] federal government” that resulted from former President Donald Trump’s four years in office. Obama also pointed out that the lack of a stable congressional majority has prevented him and current President Joe Biden from taking an even stronger stance on climate change. However, Obama remain sconfident that Biden’s Build Back Better Framework, which would set the US on course to meet its climate goals, would be passed in coming weeks. The legislation, once approved by the US Congress, would devote at least US $1.7 trillion dollars to reduce greenhouse gas emissions by over a billion metric tons by the end of 2030. Young people have more at stake in the fight against climate change Greta Thunberg addresses climate strikers at Civic Center Park in Denver, Colorado. Thunberg is one climate activist Obama praised for inspiring millions in the fight against climate change. Though Obama noted that at times, he was “doubtful that humanity can get its act together before it’s too late”, this cynicism was countered by the prevailing efforts of young climate activists around the world. Addressing all the young people, who Obama said, had “more stake in this fight than anybody else,” he said: “I want you to stay angry. I want you to stay frustrated. Channel that anger, harness that frustration.” “Because that’s what’s required to meet this challenge. Solving a problem this big and this important has never happened all at once.” Image Credits: COP26, Andy Bosselman, Streetsblog Denver/Flickr. Children’s Health Hit Hardest by Climate Change – but Cleaner Air, Greener Cities and Healthier Foods Can Create Cascade of Benefits 07/11/2021 Elaine Ruth Fletcher Rosamund Kissi-Debrah, mother of 11-year Ella, whose 2013 death from severe asthma was the first to be recognized by a court as caused by air pollution. Greening cities, investing in urban bike lanes rather than new roads, and making plant-based foods cheaper and easier to access than ultra-processed foods. This is a doctor’s prescription for a healthier planet. As climate negotiators at Glasgow’s COP26 conference remain locked in debate over the big-picture ambition of targets for global CO2 emissions reductions, and how to finance them, health advocates are trying to raise the profile of climate policies that would yield far-reaching knock-on benefits to the health of almost everyone on earth – but particularly for children, women and people living in some the poorest nations of the world. “We have sacrificed children all around the world to air pollution,” said Rosamund Kissi-Debrah, noting that some 500,000 children a year die from air pollution. Kissi-Debrah was speaking at the COP26 “Triple Win Scenario” event on Friday, co-sponsored by the WHO and the World Resources Institute. Kissi-Debrah’s 11-year-old girl daughter, Ella, was one of those victims. But her death from severe asthma in 2013 set a precedent: it was the first to be recognised by a court anywhere in the world as air-pollution induced. "We have sacrificed children all around the world to #airpollution" – caused by the same sources of #climatechange: Rosamund Kissi-Debrah, mother of 9-year-old Ella at #COP26. Ella's death from #dirtyair was the first to be recognized by a court in 2020: https://t.co/mf8LyLAsmb — Health Policy Watch – Global Health News Reporting (@HealthPolicyW) November 5, 2021 Like many Londoners, and many more urban dwellers in low- and middle-income cities around the world, Ella had lived in a heavily trafficked and heavily polluted neighbourhood. Shifting travel to greener modes, greening cities with more trees and making cities more walkable are among the climate strategies that health forces are advocating, and could all make a difference to the next generation. “Be serious, stop burning fossil fuels because those fossil fuels go into the air and into my lungs and yours. When you think about the planet, think about a couple of little, pink lungs,” said Dr Maria Neira, Director of the Department of Public Health, Climate & Environment, at the event. She noted that some 90% of the world’s population is exposed to unhealthy air pollution levels, leading to seven million deaths a year. Children among those worst affected The COVID-19 pandemic and climate change have created a perfect storm for increased malnutrition, child wasting and stunting, and maternal anaemia in parts of Africa. The fact that children are among those worst affected by climate change is underscored by a new review of the knowledge about climate change on child health, published by the Lancet on Sunday. “Present and future generations of children bear and will continue to bear an unacceptably high disease burden from climate change,” states the review’s authors, a group of Swedish experts from the Karolinksa Institute and elsewhere. “Through its far-reaching impact on all parts of society, climate change will challenge the very essence of children’s rights to survival, good health, wellbeing, education, and nutrition as enshrined by the Convention on the Rights of the Child and emphasised in the UN Sustainable Development Goals,” they note. “Climate change threatens to exaggerate the vulnerabilities of children and other populations at risk and could substantially hamper future progress and possibly even reverse the improvements made in child survival and wellbeing during recent decades,” concludes the review, suggesting that climate change needs to be better integrated into the SDG goals that cover children’s health overall.” Glasgow moment for health advocates Woman receives food assistance after widespread flooding the Horn of Africa and East Africa in 2020, linked by meterologists to climate change. But air pollution is only one of a range of ways in which our addiction to fossil fuels is delivering a double whammy to health – and children’s health in particular. Other, even more direct impacts include deaths and illness from extreme heat, storms, flooding, fires and drought. In addition, reduced food production capacity, an expanding geographic range for many infectious diseases, and increasing risk of new animal-borne diseases leaping from the wild to burgeoning cities – as SARS-CoV2 did – are imminent threats too. Given the rapid pace of climate change, “it won’t be long before the entire population of the world is affected, directly or indirectly,” said Julia Gillard, chair of the board of the UK-based philanthropy, Wellcome Trust and former Australian Prime Minister. Gillard was speaking at the COP26 “Global Conference on Health and Climate Change,” co-hosted by the World Health Organization (WHO) in Glasgow on Saturday. At the conference, co-sponsored by Wellcome, three UK-based universities and civil society groups, speakers warned of the burgeoning global health crisis that would result from inaction on climate change. “We are used to talking about climate as an environmental challenge, an economic challenge, an equity challenge. But it is also one of the most urgent health challenges facing us all today,” said Gillard. #Breaking #COP26: Health and Climate Experts Warn of Climate-Related Health Crisis https://t.co/kLWSb4Ilkc @JuliaGillard @DrTedros @WHO @Centre @JeniMiller @GCUclimatejust @jafryt @DrMariaNeira — Global Climate and Health Alliance (@GCHAlliance) November 6, 2021 Integrated policies not just global goals Sir Andy Haines, Professor of Environmental Change and Public Health at the London School of Hygiene and Tropical Medicine, speaking at the COP26 Climate and Health Summit. Tackling the root sources of climate change more rapidly can generate immediate savings for health systems and societies. But that will require not only big picture targets but a complete rethinking of policies, regulations, taxes and finance incentives at national and local levels, experts at the conference pointed out. “We need people to work together for integrated solutions,” said Professor Andy Haines of the London School of Hygiene and Tropical Medicine, who has written extensively on the planetary limits of not only temperature but also water, agricultural and forest ecosystems, which humankind needs to preserve to survive and thrive. Integration means recognising, for instance, that “the minister of transport is probably more a minister of health than the minister of health”, said Richard Smith, president of the UK Health Alliance on Climate Change. Commitment to ending financing for fossil fuel Twenty-six countries, including the US, UK, Canada and Italy, as well as the European Investment Bank and the French development agency, Agence Française de Développement, signed a commitment late last week to “end new direct public support for the international unabated fossil fuel energy sector by the end of 2022, except in limited and clearly defined circumstances that are consistent with a 1.5°C warming limit and the goals of the Paris Agreement”. The signatories also committed to prioritising their support “fully towards the clean energy transition”, using their resources to “enhance what can be delivered by the private sector”. They also commit to trying to persuade other governments, export credit agencies and public finance institutions to implement similar commitments into COP27 and beyond. According to WHO climate scientist Dr Diarmid Campell-Lendrum, $5.9 trillion is spent on direct and indirect subsidies to the fossil fuel industry each year. “We need to stop spending money on the wrong things and start spending it on the right things,” said Campbell-Lendrum, who cycled 1,600 km from Geneva to the Glasgow summit to drive home his point. He bore with him a letter calling for more climate action, signed by some 300 organisations, representing some 45 million health care professionals around the world. In London, Campbell-Lendrum was met by a raft of other climate cycle enthusiasts who continued the relay, getting the letter to Glasgow, where it was delivered to the COP26 leadership. https://twitter.com/i/status/1454817969276690436 Image Credits: Christine Olson/Flickr, IFRC, Paul Chappells. The African Medicines Agency Countdown 05/11/2021 Editorial team Thirty-nine of the African Union’s 55 member states have now signed and/or ratified the African Medicines Agency Treaty, as of 6 July 2024, with Kenya, the Democratic Republic of Congo and Cape Verde amongst the latest to swing behind the treaty. As the countdown for other nations to sign continues, Health Policy Watch is tracking progress on our AMA Countdown, website developed in collaboration with the African Medicines Agency Treaty Alliance. Here you can find the latest data on who has signed the treaty, ratified the treaty – and who is yet to sign – as well as links to sources and resources related to the African Medicines Agency Treaty process: Multimedia available for download: Find up-to-date infographics describing what countries have signed, signed and ratified, and signed, ratified and deposited the AMA treaty – in .png and interactive formats available for embed or download. African Union FAQs on the AMA Treaty Click to access 41269-doc-AMA_FAQs_rev.pdf Official African Union infographic repository Multilingual links to the AMA Treaty: The AMA Treaty in English: The AMA Treaty in French: The AMA Treaty in Arabic: The AMA Treaty in Portuguese: African Medicines Agency Treaty Alliance: AMATA joint statement, 5 November 2021, at the time that the AMA Treaty came into force. Breaking: Majority of African Countries Have Now Signed African Medicines Agency Treaty, Enabling Better Access to Newer, Safer Medicines 05/11/2021 Kerry Cullinan & Elaine Ruth Fletcher Pharmacy at Zouan health centre, Cote d’Ivoire; creation of an African Medicines Agency is intended to streamline regulatory approvals, improving quality and availability of medicines. Signatories to the new African Medicines Agency Treaty have now reached 28 countries – more than half of the African Union’s 55 member states – with the balance tipping as Uganda signed the treaty instrument last week. On Friday, 5 November, after more than a decade of preparations, the African Medicine Agency (AMA) treaty also came into force officially – clearing the way for the AMA to begin operations as a formal entity. And support for the treaty seemed to be picking up momentum with Cote d’Ivoire also signing the treaty on 29 October just ahead of Uganda’s signature on 3 November. See all the data here on our special website: African Medicines Agency Countdown, where we will be tracking all the latest developments in stories and interactive infographics. Despite the building support for the AMA, it will take more time, money and most of all – signatories from more of Africa’s powerhouse nations – to ensure that the new AMA entity can fulfill its mandate to ensure more rapid access to safer, newer and higher quality medicines across the continent. South Africa, Nigeria, Kenya and Ethiopia are among the 27 AU member states that have yet to even sign, yet alone ratify, the treaty document, which was first approved by the African Union in 2019. But with the AMA treaty coming into full force, exactly one month after the first 15 countries ratified and deposited the treaty instrument, no one is losing time. An AU meeting, set for February 2022, will select a country to host the new AMA headquarter and operations. Following that, formal structures will have to be set up and money raised to support its many crucial tasks. While a long road remains, AMA special envoy, Michel Sidibé said that the treaty’s entry into force is a ‘historic moment’. Historic moment today with the entry into force of the African Medicines Agency treaty. Bravo to the member states! We are grateful to President @AUC_MoussaFaki for his inspirational leadership and thank @AmiraDSA, @NEPAD_Mayaki, @DrTedros and all partners for their support. pic.twitter.com/a9IFitbFWz — Michel Sidibé (@MichelSidibe) November 5, 2021 COVID pandemic has sharpened the need for a continent-wide medicines agency The African Medicines Agency Treaty Alliance (AMATA), a coalition of patient civil society groups, academic institutions and industry, congratulated the first 15 African countries to ratify and deposit the treaty. AMATA called upon all other AU member states to quickly follow suit. Some 28 countries have so far signed the treaty, the majority in western Africa. Among those signatories, 10 have yet to ratify the treaty and three have still to deposit their ratifications with the African Union. The COVID-19 pandemic has sharpened the need for a continental agency that is able to fast-track approval for crucial vaccines and other medical products, AMATA said in its satement Friday: “COVID-19 has demonstrated that health security will only be achieved through concerted efforts and cross-border collaboration. “We call on all AU Heads of State to seize this historic opportunity to have one regulatory affairs oversight across the continent to enhance national, regional and continental regulation of medical products and oversee rapid and effective market authorization of safe, quality, effective and accessible medical products, for the good of all African people.” AMATA also called on the AMA Governing Board to rapidly move to put into place: A solid governance structure; Robust regulatory infrastructures; Adequate financial and human resources. AMATA also asked that the AMA governing board “recognise patients as key partners in the management structures and development of the agency”. Need for more AMA treaty signatories and quick operationalization Dr Maïmouna Diop Ly , AMATA board member AMATA executive board member Dr Maïmouna Diop Ly told Health Policy Watch that three critical tasks lay ahead in order for the agency to be successful. “There is a need to ensure that a critical number of countries sign the treaty to enable a quick operationalization of AMA,” said Diop Ly. “The statutory organs – the conference of state parties, governing board, secretariat and technical committees – should be put in place to ensure its functionality,” she added. “Finally, the allocation of adequate resources from countries’ contribution and partners is needed and should be part of the discussion of 2022 national budgets,” concluded Diop Ly, who is a health specialist with the African Development Bank and an advisor to the Senegal-based public health NGO, Speak-Up Africa. Potential lies to reduce market barriers to new medicines and fight fakes Andy Gray, senior lecturer in pharmacology at the University of KwaZulu-Natal in South Africa, said that AMA’s greatest potential lies “in the field of harmonisation of regulatory systems, which should reduce the barriers to market entry in Africa”. “The AMA is not intended to be a supranational regulator, and will not make decisions in the way the EMA does, but it could help in bringing national medicines regulatory authorities together, simplifying systems and reducing redundancy,” explained Gray. Over a quarter of the continent’s medicines are substandard or falsified, while only 2% are produced in Africa, according to AUDA. Through the harmonized regulatory framework, norms and standards, AMA will enable better access and equity to safe, quality medicine, medical products to African patients. This will also bring access to new and innovative technology for vaccines, medicine, medical devices, etc that will serve patients. The huge challenge of expanding universal health coverage – including health insurance – can also be advanced more systematically, with the support of new AMA structures – which should ease affordable access to medications, experts say. Proposed nearly a decade ago A continental medicine agency was first proposed a decade ago, and African Union member states adopted the AMA treaty almost three years ago. But the treaty could only be enforced once 15 AU member states had formally notified the AU Commission that they had ratified the treaty. This happened 30 days ago, when Cameroon became the 15th country to do so, thus setting in motion the formal establishment of the agency. The main aims of the AMA, as listed by the AU Development Agency (AUDA), are to: Support the growth of local pharmaceutical production Evaluate medical products to treat priority diseases identified by the AU Regularly inspect, coordinate and share information about products that are authorised for marketing. Coordinate reviews of clinical trial applications for vaccines and assess product dossiers such as bio-similars. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites. Collaborate with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs) to identify substandard and fake medical products Develop common standards and regulations, which will ensure that the continent’s legislation is harmonised. Responding to the medical crisis caused by COVID-19, the International Alliance of Patients’ Organizations (IAPO) helped to set up a lobby group, the African Medicines Agency Treaty Alliance (AMATA), to push for the speedier establishment of the agency. AMA ‘critically important’ says United States Meanwhile, Jessie Lapenn, the US Ambassador to the African Union, described the AMA as critical important to improving health security in Africa. “The AMA will be another critically important African institution that is part of the broader architecture that will be crucial for strengthening the continent’s health security,” Lapenn said at Thursday’s Africa Centres for Disease Control media briefing. “The US government and US private sector are very much looking forward to collaboration with AMA,” Lapenn added. Along with Cameroon, other countries to have both ratified the AMA and “deposited the instrument of ratification” at the AU (a letter from the head of state informing it of ratification) are predominantly west and north African, and/ Francophone nations, including: Algeria, Benin, Burkina Faso, Gabon, Guinea, Mali, Mauritius, Niger, Seychelles, and Sierra Leone. That may be due, in part, to the fact that the AU’s Special Envoy on the AMA is Michel Sidibé, Mali’s ex-Minister of Health. Now it will be up to southern, eastern and northern Africa to catch up – although Rwanda, Namibia and Zimbabwe have also been among the first to have ratified and deposited the treaty instrument. They were followed by Uganda, which signed the treaty on November 3. https://twitter.com/sabrinah_nati/status/1456617479430709249 Pharma groups welcome AMA’s creation Pharmaceutical companies have long complained about how complicated it is to get medicines approved in Africa and how long it takes – particularly in comparison to Europe, which processes applications via a central European Medicines Agency (EMA). A significant number of African countries’ national medicine regulatory authorities are under-resourced and lacking in expertise. Greg Perry, Assistant Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), welcomed the landmark moment where the treaty has now come into force, describing it as “one step closer to achieving a continent-wide regulatory agency”. “We look forward to the full implementation of the AMA, which will be a game-changer for all Africans to access safe, effective and quality medical products in a timely manner,” said Perry. -Updated on 8 November, 2021 Image Credits: James Oatway/IMF – Healthcare Focus , ©EC/ECHO/Anouk Delafortrie, LinkedIn. Pfizer Says New Anti-Viral Drug Combination Cuts Risks Of Serious COVID-19 By 89% 05/11/2021 Aishwarya Tendolkar Pfizer’s experimental pill works by inhibiting replication of SARS-CoV2 virus. Pfizer Friday announced that its experimental COVID-19 oral antiviral drug PAXLOVID™ reduced risks of hospitalization and death by 89% among patients who received the drug within the first three days of their illness. The company said it had stopped its Phase 2/3 trial on the drug owing to the success rate seen in an interim analysis of 1,219 adults enrolled in the study – who also had chronic health conditions placing them at higher risk of severe COVID. Pfizer is the second pharma firm, after Merck Sharp & Dohme (Merck), to announce highly promising results for an oral drug treatment that reduces serious COVID-19 illness – although the Pfizer results were even more stunning. PAXLOVID™ has the potential to eliminate up to nine out of ten hospitalizations, Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said in a press release. It’s a gamechanger,” Pfizer CEO Albert Bourla told @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” If approved for emergency use by the United States Food and Drug Administration (US FDA), PAXLOVID™ would become the first oral COVID antiviral of its kind. The novel treatment includes a newly- designed SARS-CoV-2-3CL protease inhibitor used in combination with a common anti-HIV drug, ritonavir. Bourla told CNBC that the filing for the drug is expected to be submitted before the U.S. Thanksgiving holiday on Nov. 25. “It’s a gamechanger,” Pfizer CEO Albert Bourla tells @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” https://t.co/IUYCAbZUu9 pic.twitter.com/QTFfJBizPs — CNBC (@CNBC) November 5, 2021 Pfizer’s results more impressive than Merck’s The Pfizer announcement follows Merck’s announcement last month that it’s new oral pill, molnupiravir, had reduced the risks of hospitalization and death by some 50% among people with mild or moderate COVID. The Merck pill, which was approved by UK regulators last week, introduces errors into the genetic code of the SARS-CoV2 virus that it targets, slowing virus replication. Pfizer’s reported results were even more impressive, however. Based on a primary analysis of interim data from 1,219 at-risk adults who were enrolled by September 29, 2021, only three people administered the drug within three days of sympton onset were hospitalized through day 28 of their illness, with no deaths. In the control group, 27 people were hospitalized, with seven subsequent deaths. When the company decided to stop recruiting more patients, their enrollment had reached 70 percent of the planned 3,000 patients across North and South America, Europe, Africa, and Asia. Pfizer drug is based upon a novel protease inhibitor, PF-07321332, that blocks the activity of the enzyme that the coronavirus needs to replicate. Co-administration of ritonavir means that protease inhibitor remains active in the body for longer periods of time to combat the virus. Treatment involves the administration of three PAXLOVID™ pills, twice a day, for five days. Pfizer says it will also ensure equitable access to new drug formulation While Merck’s molnupiravir pill is set to be licensed for generic production in most low- and middle-income countries, Pfizer said that it will offer PAXLOVID™ worldwide, through a tiered pricing approach – while maintaining control of its IP. Last week, Merck and the Medicines Patent Pool signed an agreement that paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell their treatment molnupiravir at discounted prices to more than 105 countries worldwide, once the drug receives approval by the World Health Organization. Pfizer, in contrast, said that its tiered pricing would be “based on the income level of each country to promote equity of access across the globe. “High and upper-middle income countries will pay more than lower income countries,” Pfizer said, adding that it had already entered into advance purchase agreements with “multiple countries and is in negotiations with several others” – without naming which. “Pfizer has also begun and will continue to invest up to approximately $1 billion to support the manufacturing and distribution of this investigational treatment, including exploring potential contract manufacturing options to help ensure access across low- and middle-income countries, pending regulatory authorization.” Image Credits: Wikimedia Commons, peterschreiber.media/Shutterstock . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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Pandemic Treaty Offers Opportunity to Repair Fault Lines in COVID-19 Response – and Address Equity 09/11/2021 Kerry Cullinan A nurse takes the temperature of a child suspected of COVID-19 symptoms in a Lebanese public health centre. An international pandemic treaty based on equity could be the antidote to current weaknesses and imbalances in the global response to COVID-19, according to a group of influential authors in a Lancet paper published on Tuesday. A number of the authors are associated with The Independent Panel for Pandemic Preparedness and Response chaired by Helen Clark and Ellen Sirleaf Johnson, which was set up to assess the World Health Organization’s (WHO) response to COVID-19. Based on a timeline developed by the panel that lays out the global COVID-19 response, the authors conclude that the International Health Regulations (IHR) are too weak, and the required country actions are too slow, to protect the world against pandemics. Revised after the 2005 Severe Acute Respiratory Syndrome (SARS) outbreak, the IHR focus on balancing disease notification and health risks with international trade and travel considerations. They specify when and how Member States should notify WHO of a local disease outbreak, and what actions WHO and States should take after that notification. The IHR are currently the only legally binding international instrument governing countries’ obligations to report and respond to pathogens that could result in cross-border disease outbreaks and potential public health emergencies. In their review, the authors identified a number of significant IHR weaknesses, including: constraints on WHO reporting publicly about national events with pandemic potential; the need for greater specificity on the information that countries need to share with WHO; and a streamlined process to facilitate WHO verification of events within 24 hours of the first signals of an outbreak being received. Special World Health Assembly The article comes a few weeks before global leaders meet at a World Health Assembly special session (29 November – 1 December) to consider adopting an “instrument or treaty” to address pandemic preparedness and response. “It’s clear: if a new, fast-spreading pathogen were to emerge next month, the current IHR regime would not protect people and trade as intended,” said Dr Sudhvir Singh, lead author on the paper and an advisor to the Independent Panel. “We suggest change to the IHR and a new treaty or another instrument that would result in more information shared faster, WHO able to investigate rapidly, all countries moving immediately to assess risk; and tools, like tests and vaccines, available to all who need them.” Georgetown University’s Dr Alexandra Phelan added that “COVID-19 has shown that the existing obligations under the IHR are insufficient for our interdependent and digital world.” “Our analysis demonstrates that collectively, countries urgently need to update our international system to respond to the potential rapid spread of a high impact respiratory pathogen,” said Phelan. “We have concrete suggestions for ways in which the IHR may be revised or amended, as well as the approach and issues that must be covered in any new legal framework, like a pandemic treaty.” Four reasons for a pandemic treaty The authors advance four reasons why a pandemic treaty “presents the opportunity to enact comprehensive reform in pandemic preparedness and response”. “First, a pandemic treaty centred on the principle of equity would be an important signal of international commitment to guard against the entrenchment of global division and injustice.” A pandemic treaty offers an opportunity to “develop and instil norms of equity, justice, and global public goods of pandemic preparedness and response”, they argue. “Second, a pandemic treaty could provide high-level complementarity to the IHR and any potential post-pandemic reforms and proactive multidisciplinary approaches to zoonotic risk,” they argue. Their third argument is that a treaty establishes greater accountability, outbreak support, and global access to vital public health information. Finally, a pandemic treaty could provide the opportunity to develop “a solid evidence base for non-pharmaceutical interventions” that might prevent the next outbreak from becoming a pandemic. “The upcoming Special Session of the World Health Assembly is a critical opportunity for Member States to move ahead with strengthening the IHR and to agree on a process for negotiating a pandemic treaty. We must not lose this opportunity to protect global public health and future generations,” said Phelan. At a recent event hosted by G2H2, civil society organisations expressed fear that a pandemic treaty was a distraction from the TRIPS waiver. But Björn Kümmel, deputy head of the global health unit in the German Federal Ministry of Health, disputed that there is any direct political link between the treaty and the TRIPS waiver. Kümmel added that amending the IHR also would take time to negotiate. And a key question here is: “would they be a game-changer for the next pandemic to come? Certainly not,” he added, noting that there is “no compliance mechanism that currently is foreseen in the IHR.” Image Credits: UNICEF . Obama Critical of China and Russia’s ‘Dangerous Lack of Urgency’ in Climate Change at COP26 08/11/2021 Raisa Santos Former US President Barack Obama speaking at COP26 Former US President Barack Obama openly criticized two of the world’s largest CO2 emitting countries – Russia and China, for their “dangerous lack of urgency” in discussing the pressing matters of climate change this past week during COP26. Both Chinese President Xi Jinping and Russian President Vladimir Putin failed to make an appearance with other global leaders at the 26th United Nations Climate Change Conference in Glasgow, which Obama found to be “particularly discouraging,” as he addressed a room of climate experts at the event on Monday. “We need advanced economies like the US and Europe leading on [the issue of climate change]. But we also need China and India, we need Russia, just as we need Indonesia and South Africa and Brazil leading on this issue. We can’t afford anybody to be on the sidelines.” Obama noted that while there has been some progress made in the six years since the Paris Agreement, the legally binding international treaty on climate change, the world still falls short of their commitment to limit global warming to well below 1.5 C. “Here in Glasgow we see the promise of further progress. What is also true is that collectively and individually, we are still falling short. We have not done nearly enough to address this crisis.” “We are going to have to do more and whether that happens or not to a large degree is going to depend on you,” said Obama, calling for collective action from young people and politicians alike to take climate change seriously. Twenty countries pledge to end public finance of international fossil fuel development Although most nations have failed to be ambitious in their climate goals in the past week of COP26, said Obama, significant accomplishments and hard-won commitments have been made during the climate conference. One such commitment was for high-income countries to help low- and middle-income countries move away from fossil fuels. Back in September, US President Joe Biden told the UN General Assembly that the US would provide more than $11 billion in climate aid annually by 2024 to developing nations vulnerable to extreme weather and rising temperatures. In addition, the US and 20 other countries have pledged to stop publicly financing international fossil fuel development, with limited exceptions. “We will end new public direct support for the international unabated fossil fuel energy sector by the end of 2022,” the declaration read. The 20 countries that signed the pledge include Denmark, Italy, Finland, Costa Rica, Ethiopia, Gambia, New Zealand and the Marshall Islands, plus five development institutions including the European Investment Bank and the East African Development Bank. This deal does go further than a pledge made earlier in the year by the G20 to end international financing of coal-based power generation outside their own countries. However, this declaration does not include major Asian countries responsible for financing a majority of overseas fossil fuel projects. Climate change cannot be a partisan issue While collective action in fighting climate change requires international cooperation, Obama noted the geopolitical tensions that have arisen as a result of the pandemic, but called for the world to step up despite these tensions. “Climate change can’t be seen anywhere in the world as just an opportunity to score political points.” “Saving the planet isn’t a partisan issue. Nature, physics, science, do not care about party affiliation,” he added. Climate change, in the US particularly, has become a partisan issue, causing what Obama referred to as a “lack of leadership on America’s part” and the “open hostility towards climate science at the very top of the [US] federal government” that resulted from former President Donald Trump’s four years in office. Obama also pointed out that the lack of a stable congressional majority has prevented him and current President Joe Biden from taking an even stronger stance on climate change. However, Obama remain sconfident that Biden’s Build Back Better Framework, which would set the US on course to meet its climate goals, would be passed in coming weeks. The legislation, once approved by the US Congress, would devote at least US $1.7 trillion dollars to reduce greenhouse gas emissions by over a billion metric tons by the end of 2030. Young people have more at stake in the fight against climate change Greta Thunberg addresses climate strikers at Civic Center Park in Denver, Colorado. Thunberg is one climate activist Obama praised for inspiring millions in the fight against climate change. Though Obama noted that at times, he was “doubtful that humanity can get its act together before it’s too late”, this cynicism was countered by the prevailing efforts of young climate activists around the world. Addressing all the young people, who Obama said, had “more stake in this fight than anybody else,” he said: “I want you to stay angry. I want you to stay frustrated. Channel that anger, harness that frustration.” “Because that’s what’s required to meet this challenge. Solving a problem this big and this important has never happened all at once.” Image Credits: COP26, Andy Bosselman, Streetsblog Denver/Flickr. Children’s Health Hit Hardest by Climate Change – but Cleaner Air, Greener Cities and Healthier Foods Can Create Cascade of Benefits 07/11/2021 Elaine Ruth Fletcher Rosamund Kissi-Debrah, mother of 11-year Ella, whose 2013 death from severe asthma was the first to be recognized by a court as caused by air pollution. Greening cities, investing in urban bike lanes rather than new roads, and making plant-based foods cheaper and easier to access than ultra-processed foods. This is a doctor’s prescription for a healthier planet. As climate negotiators at Glasgow’s COP26 conference remain locked in debate over the big-picture ambition of targets for global CO2 emissions reductions, and how to finance them, health advocates are trying to raise the profile of climate policies that would yield far-reaching knock-on benefits to the health of almost everyone on earth – but particularly for children, women and people living in some the poorest nations of the world. “We have sacrificed children all around the world to air pollution,” said Rosamund Kissi-Debrah, noting that some 500,000 children a year die from air pollution. Kissi-Debrah was speaking at the COP26 “Triple Win Scenario” event on Friday, co-sponsored by the WHO and the World Resources Institute. Kissi-Debrah’s 11-year-old girl daughter, Ella, was one of those victims. But her death from severe asthma in 2013 set a precedent: it was the first to be recognised by a court anywhere in the world as air-pollution induced. "We have sacrificed children all around the world to #airpollution" – caused by the same sources of #climatechange: Rosamund Kissi-Debrah, mother of 9-year-old Ella at #COP26. Ella's death from #dirtyair was the first to be recognized by a court in 2020: https://t.co/mf8LyLAsmb — Health Policy Watch – Global Health News Reporting (@HealthPolicyW) November 5, 2021 Like many Londoners, and many more urban dwellers in low- and middle-income cities around the world, Ella had lived in a heavily trafficked and heavily polluted neighbourhood. Shifting travel to greener modes, greening cities with more trees and making cities more walkable are among the climate strategies that health forces are advocating, and could all make a difference to the next generation. “Be serious, stop burning fossil fuels because those fossil fuels go into the air and into my lungs and yours. When you think about the planet, think about a couple of little, pink lungs,” said Dr Maria Neira, Director of the Department of Public Health, Climate & Environment, at the event. She noted that some 90% of the world’s population is exposed to unhealthy air pollution levels, leading to seven million deaths a year. Children among those worst affected The COVID-19 pandemic and climate change have created a perfect storm for increased malnutrition, child wasting and stunting, and maternal anaemia in parts of Africa. The fact that children are among those worst affected by climate change is underscored by a new review of the knowledge about climate change on child health, published by the Lancet on Sunday. “Present and future generations of children bear and will continue to bear an unacceptably high disease burden from climate change,” states the review’s authors, a group of Swedish experts from the Karolinksa Institute and elsewhere. “Through its far-reaching impact on all parts of society, climate change will challenge the very essence of children’s rights to survival, good health, wellbeing, education, and nutrition as enshrined by the Convention on the Rights of the Child and emphasised in the UN Sustainable Development Goals,” they note. “Climate change threatens to exaggerate the vulnerabilities of children and other populations at risk and could substantially hamper future progress and possibly even reverse the improvements made in child survival and wellbeing during recent decades,” concludes the review, suggesting that climate change needs to be better integrated into the SDG goals that cover children’s health overall.” Glasgow moment for health advocates Woman receives food assistance after widespread flooding the Horn of Africa and East Africa in 2020, linked by meterologists to climate change. But air pollution is only one of a range of ways in which our addiction to fossil fuels is delivering a double whammy to health – and children’s health in particular. Other, even more direct impacts include deaths and illness from extreme heat, storms, flooding, fires and drought. In addition, reduced food production capacity, an expanding geographic range for many infectious diseases, and increasing risk of new animal-borne diseases leaping from the wild to burgeoning cities – as SARS-CoV2 did – are imminent threats too. Given the rapid pace of climate change, “it won’t be long before the entire population of the world is affected, directly or indirectly,” said Julia Gillard, chair of the board of the UK-based philanthropy, Wellcome Trust and former Australian Prime Minister. Gillard was speaking at the COP26 “Global Conference on Health and Climate Change,” co-hosted by the World Health Organization (WHO) in Glasgow on Saturday. At the conference, co-sponsored by Wellcome, three UK-based universities and civil society groups, speakers warned of the burgeoning global health crisis that would result from inaction on climate change. “We are used to talking about climate as an environmental challenge, an economic challenge, an equity challenge. But it is also one of the most urgent health challenges facing us all today,” said Gillard. #Breaking #COP26: Health and Climate Experts Warn of Climate-Related Health Crisis https://t.co/kLWSb4Ilkc @JuliaGillard @DrTedros @WHO @Centre @JeniMiller @GCUclimatejust @jafryt @DrMariaNeira — Global Climate and Health Alliance (@GCHAlliance) November 6, 2021 Integrated policies not just global goals Sir Andy Haines, Professor of Environmental Change and Public Health at the London School of Hygiene and Tropical Medicine, speaking at the COP26 Climate and Health Summit. Tackling the root sources of climate change more rapidly can generate immediate savings for health systems and societies. But that will require not only big picture targets but a complete rethinking of policies, regulations, taxes and finance incentives at national and local levels, experts at the conference pointed out. “We need people to work together for integrated solutions,” said Professor Andy Haines of the London School of Hygiene and Tropical Medicine, who has written extensively on the planetary limits of not only temperature but also water, agricultural and forest ecosystems, which humankind needs to preserve to survive and thrive. Integration means recognising, for instance, that “the minister of transport is probably more a minister of health than the minister of health”, said Richard Smith, president of the UK Health Alliance on Climate Change. Commitment to ending financing for fossil fuel Twenty-six countries, including the US, UK, Canada and Italy, as well as the European Investment Bank and the French development agency, Agence Française de Développement, signed a commitment late last week to “end new direct public support for the international unabated fossil fuel energy sector by the end of 2022, except in limited and clearly defined circumstances that are consistent with a 1.5°C warming limit and the goals of the Paris Agreement”. The signatories also committed to prioritising their support “fully towards the clean energy transition”, using their resources to “enhance what can be delivered by the private sector”. They also commit to trying to persuade other governments, export credit agencies and public finance institutions to implement similar commitments into COP27 and beyond. According to WHO climate scientist Dr Diarmid Campell-Lendrum, $5.9 trillion is spent on direct and indirect subsidies to the fossil fuel industry each year. “We need to stop spending money on the wrong things and start spending it on the right things,” said Campbell-Lendrum, who cycled 1,600 km from Geneva to the Glasgow summit to drive home his point. He bore with him a letter calling for more climate action, signed by some 300 organisations, representing some 45 million health care professionals around the world. In London, Campbell-Lendrum was met by a raft of other climate cycle enthusiasts who continued the relay, getting the letter to Glasgow, where it was delivered to the COP26 leadership. https://twitter.com/i/status/1454817969276690436 Image Credits: Christine Olson/Flickr, IFRC, Paul Chappells. The African Medicines Agency Countdown 05/11/2021 Editorial team Thirty-nine of the African Union’s 55 member states have now signed and/or ratified the African Medicines Agency Treaty, as of 6 July 2024, with Kenya, the Democratic Republic of Congo and Cape Verde amongst the latest to swing behind the treaty. As the countdown for other nations to sign continues, Health Policy Watch is tracking progress on our AMA Countdown, website developed in collaboration with the African Medicines Agency Treaty Alliance. Here you can find the latest data on who has signed the treaty, ratified the treaty – and who is yet to sign – as well as links to sources and resources related to the African Medicines Agency Treaty process: Multimedia available for download: Find up-to-date infographics describing what countries have signed, signed and ratified, and signed, ratified and deposited the AMA treaty – in .png and interactive formats available for embed or download. African Union FAQs on the AMA Treaty Click to access 41269-doc-AMA_FAQs_rev.pdf Official African Union infographic repository Multilingual links to the AMA Treaty: The AMA Treaty in English: The AMA Treaty in French: The AMA Treaty in Arabic: The AMA Treaty in Portuguese: African Medicines Agency Treaty Alliance: AMATA joint statement, 5 November 2021, at the time that the AMA Treaty came into force. Breaking: Majority of African Countries Have Now Signed African Medicines Agency Treaty, Enabling Better Access to Newer, Safer Medicines 05/11/2021 Kerry Cullinan & Elaine Ruth Fletcher Pharmacy at Zouan health centre, Cote d’Ivoire; creation of an African Medicines Agency is intended to streamline regulatory approvals, improving quality and availability of medicines. Signatories to the new African Medicines Agency Treaty have now reached 28 countries – more than half of the African Union’s 55 member states – with the balance tipping as Uganda signed the treaty instrument last week. On Friday, 5 November, after more than a decade of preparations, the African Medicine Agency (AMA) treaty also came into force officially – clearing the way for the AMA to begin operations as a formal entity. And support for the treaty seemed to be picking up momentum with Cote d’Ivoire also signing the treaty on 29 October just ahead of Uganda’s signature on 3 November. See all the data here on our special website: African Medicines Agency Countdown, where we will be tracking all the latest developments in stories and interactive infographics. Despite the building support for the AMA, it will take more time, money and most of all – signatories from more of Africa’s powerhouse nations – to ensure that the new AMA entity can fulfill its mandate to ensure more rapid access to safer, newer and higher quality medicines across the continent. South Africa, Nigeria, Kenya and Ethiopia are among the 27 AU member states that have yet to even sign, yet alone ratify, the treaty document, which was first approved by the African Union in 2019. But with the AMA treaty coming into full force, exactly one month after the first 15 countries ratified and deposited the treaty instrument, no one is losing time. An AU meeting, set for February 2022, will select a country to host the new AMA headquarter and operations. Following that, formal structures will have to be set up and money raised to support its many crucial tasks. While a long road remains, AMA special envoy, Michel Sidibé said that the treaty’s entry into force is a ‘historic moment’. Historic moment today with the entry into force of the African Medicines Agency treaty. Bravo to the member states! We are grateful to President @AUC_MoussaFaki for his inspirational leadership and thank @AmiraDSA, @NEPAD_Mayaki, @DrTedros and all partners for their support. pic.twitter.com/a9IFitbFWz — Michel Sidibé (@MichelSidibe) November 5, 2021 COVID pandemic has sharpened the need for a continent-wide medicines agency The African Medicines Agency Treaty Alliance (AMATA), a coalition of patient civil society groups, academic institutions and industry, congratulated the first 15 African countries to ratify and deposit the treaty. AMATA called upon all other AU member states to quickly follow suit. Some 28 countries have so far signed the treaty, the majority in western Africa. Among those signatories, 10 have yet to ratify the treaty and three have still to deposit their ratifications with the African Union. The COVID-19 pandemic has sharpened the need for a continental agency that is able to fast-track approval for crucial vaccines and other medical products, AMATA said in its satement Friday: “COVID-19 has demonstrated that health security will only be achieved through concerted efforts and cross-border collaboration. “We call on all AU Heads of State to seize this historic opportunity to have one regulatory affairs oversight across the continent to enhance national, regional and continental regulation of medical products and oversee rapid and effective market authorization of safe, quality, effective and accessible medical products, for the good of all African people.” AMATA also called on the AMA Governing Board to rapidly move to put into place: A solid governance structure; Robust regulatory infrastructures; Adequate financial and human resources. AMATA also asked that the AMA governing board “recognise patients as key partners in the management structures and development of the agency”. Need for more AMA treaty signatories and quick operationalization Dr Maïmouna Diop Ly , AMATA board member AMATA executive board member Dr Maïmouna Diop Ly told Health Policy Watch that three critical tasks lay ahead in order for the agency to be successful. “There is a need to ensure that a critical number of countries sign the treaty to enable a quick operationalization of AMA,” said Diop Ly. “The statutory organs – the conference of state parties, governing board, secretariat and technical committees – should be put in place to ensure its functionality,” she added. “Finally, the allocation of adequate resources from countries’ contribution and partners is needed and should be part of the discussion of 2022 national budgets,” concluded Diop Ly, who is a health specialist with the African Development Bank and an advisor to the Senegal-based public health NGO, Speak-Up Africa. Potential lies to reduce market barriers to new medicines and fight fakes Andy Gray, senior lecturer in pharmacology at the University of KwaZulu-Natal in South Africa, said that AMA’s greatest potential lies “in the field of harmonisation of regulatory systems, which should reduce the barriers to market entry in Africa”. “The AMA is not intended to be a supranational regulator, and will not make decisions in the way the EMA does, but it could help in bringing national medicines regulatory authorities together, simplifying systems and reducing redundancy,” explained Gray. Over a quarter of the continent’s medicines are substandard or falsified, while only 2% are produced in Africa, according to AUDA. Through the harmonized regulatory framework, norms and standards, AMA will enable better access and equity to safe, quality medicine, medical products to African patients. This will also bring access to new and innovative technology for vaccines, medicine, medical devices, etc that will serve patients. The huge challenge of expanding universal health coverage – including health insurance – can also be advanced more systematically, with the support of new AMA structures – which should ease affordable access to medications, experts say. Proposed nearly a decade ago A continental medicine agency was first proposed a decade ago, and African Union member states adopted the AMA treaty almost three years ago. But the treaty could only be enforced once 15 AU member states had formally notified the AU Commission that they had ratified the treaty. This happened 30 days ago, when Cameroon became the 15th country to do so, thus setting in motion the formal establishment of the agency. The main aims of the AMA, as listed by the AU Development Agency (AUDA), are to: Support the growth of local pharmaceutical production Evaluate medical products to treat priority diseases identified by the AU Regularly inspect, coordinate and share information about products that are authorised for marketing. Coordinate reviews of clinical trial applications for vaccines and assess product dossiers such as bio-similars. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites. Collaborate with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs) to identify substandard and fake medical products Develop common standards and regulations, which will ensure that the continent’s legislation is harmonised. Responding to the medical crisis caused by COVID-19, the International Alliance of Patients’ Organizations (IAPO) helped to set up a lobby group, the African Medicines Agency Treaty Alliance (AMATA), to push for the speedier establishment of the agency. AMA ‘critically important’ says United States Meanwhile, Jessie Lapenn, the US Ambassador to the African Union, described the AMA as critical important to improving health security in Africa. “The AMA will be another critically important African institution that is part of the broader architecture that will be crucial for strengthening the continent’s health security,” Lapenn said at Thursday’s Africa Centres for Disease Control media briefing. “The US government and US private sector are very much looking forward to collaboration with AMA,” Lapenn added. Along with Cameroon, other countries to have both ratified the AMA and “deposited the instrument of ratification” at the AU (a letter from the head of state informing it of ratification) are predominantly west and north African, and/ Francophone nations, including: Algeria, Benin, Burkina Faso, Gabon, Guinea, Mali, Mauritius, Niger, Seychelles, and Sierra Leone. That may be due, in part, to the fact that the AU’s Special Envoy on the AMA is Michel Sidibé, Mali’s ex-Minister of Health. Now it will be up to southern, eastern and northern Africa to catch up – although Rwanda, Namibia and Zimbabwe have also been among the first to have ratified and deposited the treaty instrument. They were followed by Uganda, which signed the treaty on November 3. https://twitter.com/sabrinah_nati/status/1456617479430709249 Pharma groups welcome AMA’s creation Pharmaceutical companies have long complained about how complicated it is to get medicines approved in Africa and how long it takes – particularly in comparison to Europe, which processes applications via a central European Medicines Agency (EMA). A significant number of African countries’ national medicine regulatory authorities are under-resourced and lacking in expertise. Greg Perry, Assistant Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), welcomed the landmark moment where the treaty has now come into force, describing it as “one step closer to achieving a continent-wide regulatory agency”. “We look forward to the full implementation of the AMA, which will be a game-changer for all Africans to access safe, effective and quality medical products in a timely manner,” said Perry. -Updated on 8 November, 2021 Image Credits: James Oatway/IMF – Healthcare Focus , ©EC/ECHO/Anouk Delafortrie, LinkedIn. Pfizer Says New Anti-Viral Drug Combination Cuts Risks Of Serious COVID-19 By 89% 05/11/2021 Aishwarya Tendolkar Pfizer’s experimental pill works by inhibiting replication of SARS-CoV2 virus. Pfizer Friday announced that its experimental COVID-19 oral antiviral drug PAXLOVID™ reduced risks of hospitalization and death by 89% among patients who received the drug within the first three days of their illness. The company said it had stopped its Phase 2/3 trial on the drug owing to the success rate seen in an interim analysis of 1,219 adults enrolled in the study – who also had chronic health conditions placing them at higher risk of severe COVID. Pfizer is the second pharma firm, after Merck Sharp & Dohme (Merck), to announce highly promising results for an oral drug treatment that reduces serious COVID-19 illness – although the Pfizer results were even more stunning. PAXLOVID™ has the potential to eliminate up to nine out of ten hospitalizations, Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said in a press release. It’s a gamechanger,” Pfizer CEO Albert Bourla told @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” If approved for emergency use by the United States Food and Drug Administration (US FDA), PAXLOVID™ would become the first oral COVID antiviral of its kind. The novel treatment includes a newly- designed SARS-CoV-2-3CL protease inhibitor used in combination with a common anti-HIV drug, ritonavir. Bourla told CNBC that the filing for the drug is expected to be submitted before the U.S. Thanksgiving holiday on Nov. 25. “It’s a gamechanger,” Pfizer CEO Albert Bourla tells @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” https://t.co/IUYCAbZUu9 pic.twitter.com/QTFfJBizPs — CNBC (@CNBC) November 5, 2021 Pfizer’s results more impressive than Merck’s The Pfizer announcement follows Merck’s announcement last month that it’s new oral pill, molnupiravir, had reduced the risks of hospitalization and death by some 50% among people with mild or moderate COVID. The Merck pill, which was approved by UK regulators last week, introduces errors into the genetic code of the SARS-CoV2 virus that it targets, slowing virus replication. Pfizer’s reported results were even more impressive, however. Based on a primary analysis of interim data from 1,219 at-risk adults who were enrolled by September 29, 2021, only three people administered the drug within three days of sympton onset were hospitalized through day 28 of their illness, with no deaths. In the control group, 27 people were hospitalized, with seven subsequent deaths. When the company decided to stop recruiting more patients, their enrollment had reached 70 percent of the planned 3,000 patients across North and South America, Europe, Africa, and Asia. Pfizer drug is based upon a novel protease inhibitor, PF-07321332, that blocks the activity of the enzyme that the coronavirus needs to replicate. Co-administration of ritonavir means that protease inhibitor remains active in the body for longer periods of time to combat the virus. Treatment involves the administration of three PAXLOVID™ pills, twice a day, for five days. Pfizer says it will also ensure equitable access to new drug formulation While Merck’s molnupiravir pill is set to be licensed for generic production in most low- and middle-income countries, Pfizer said that it will offer PAXLOVID™ worldwide, through a tiered pricing approach – while maintaining control of its IP. Last week, Merck and the Medicines Patent Pool signed an agreement that paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell their treatment molnupiravir at discounted prices to more than 105 countries worldwide, once the drug receives approval by the World Health Organization. Pfizer, in contrast, said that its tiered pricing would be “based on the income level of each country to promote equity of access across the globe. “High and upper-middle income countries will pay more than lower income countries,” Pfizer said, adding that it had already entered into advance purchase agreements with “multiple countries and is in negotiations with several others” – without naming which. “Pfizer has also begun and will continue to invest up to approximately $1 billion to support the manufacturing and distribution of this investigational treatment, including exploring potential contract manufacturing options to help ensure access across low- and middle-income countries, pending regulatory authorization.” Image Credits: Wikimedia Commons, peterschreiber.media/Shutterstock . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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Obama Critical of China and Russia’s ‘Dangerous Lack of Urgency’ in Climate Change at COP26 08/11/2021 Raisa Santos Former US President Barack Obama speaking at COP26 Former US President Barack Obama openly criticized two of the world’s largest CO2 emitting countries – Russia and China, for their “dangerous lack of urgency” in discussing the pressing matters of climate change this past week during COP26. Both Chinese President Xi Jinping and Russian President Vladimir Putin failed to make an appearance with other global leaders at the 26th United Nations Climate Change Conference in Glasgow, which Obama found to be “particularly discouraging,” as he addressed a room of climate experts at the event on Monday. “We need advanced economies like the US and Europe leading on [the issue of climate change]. But we also need China and India, we need Russia, just as we need Indonesia and South Africa and Brazil leading on this issue. We can’t afford anybody to be on the sidelines.” Obama noted that while there has been some progress made in the six years since the Paris Agreement, the legally binding international treaty on climate change, the world still falls short of their commitment to limit global warming to well below 1.5 C. “Here in Glasgow we see the promise of further progress. What is also true is that collectively and individually, we are still falling short. We have not done nearly enough to address this crisis.” “We are going to have to do more and whether that happens or not to a large degree is going to depend on you,” said Obama, calling for collective action from young people and politicians alike to take climate change seriously. Twenty countries pledge to end public finance of international fossil fuel development Although most nations have failed to be ambitious in their climate goals in the past week of COP26, said Obama, significant accomplishments and hard-won commitments have been made during the climate conference. One such commitment was for high-income countries to help low- and middle-income countries move away from fossil fuels. Back in September, US President Joe Biden told the UN General Assembly that the US would provide more than $11 billion in climate aid annually by 2024 to developing nations vulnerable to extreme weather and rising temperatures. In addition, the US and 20 other countries have pledged to stop publicly financing international fossil fuel development, with limited exceptions. “We will end new public direct support for the international unabated fossil fuel energy sector by the end of 2022,” the declaration read. The 20 countries that signed the pledge include Denmark, Italy, Finland, Costa Rica, Ethiopia, Gambia, New Zealand and the Marshall Islands, plus five development institutions including the European Investment Bank and the East African Development Bank. This deal does go further than a pledge made earlier in the year by the G20 to end international financing of coal-based power generation outside their own countries. However, this declaration does not include major Asian countries responsible for financing a majority of overseas fossil fuel projects. Climate change cannot be a partisan issue While collective action in fighting climate change requires international cooperation, Obama noted the geopolitical tensions that have arisen as a result of the pandemic, but called for the world to step up despite these tensions. “Climate change can’t be seen anywhere in the world as just an opportunity to score political points.” “Saving the planet isn’t a partisan issue. Nature, physics, science, do not care about party affiliation,” he added. Climate change, in the US particularly, has become a partisan issue, causing what Obama referred to as a “lack of leadership on America’s part” and the “open hostility towards climate science at the very top of the [US] federal government” that resulted from former President Donald Trump’s four years in office. Obama also pointed out that the lack of a stable congressional majority has prevented him and current President Joe Biden from taking an even stronger stance on climate change. However, Obama remain sconfident that Biden’s Build Back Better Framework, which would set the US on course to meet its climate goals, would be passed in coming weeks. The legislation, once approved by the US Congress, would devote at least US $1.7 trillion dollars to reduce greenhouse gas emissions by over a billion metric tons by the end of 2030. Young people have more at stake in the fight against climate change Greta Thunberg addresses climate strikers at Civic Center Park in Denver, Colorado. Thunberg is one climate activist Obama praised for inspiring millions in the fight against climate change. Though Obama noted that at times, he was “doubtful that humanity can get its act together before it’s too late”, this cynicism was countered by the prevailing efforts of young climate activists around the world. Addressing all the young people, who Obama said, had “more stake in this fight than anybody else,” he said: “I want you to stay angry. I want you to stay frustrated. Channel that anger, harness that frustration.” “Because that’s what’s required to meet this challenge. Solving a problem this big and this important has never happened all at once.” Image Credits: COP26, Andy Bosselman, Streetsblog Denver/Flickr. Children’s Health Hit Hardest by Climate Change – but Cleaner Air, Greener Cities and Healthier Foods Can Create Cascade of Benefits 07/11/2021 Elaine Ruth Fletcher Rosamund Kissi-Debrah, mother of 11-year Ella, whose 2013 death from severe asthma was the first to be recognized by a court as caused by air pollution. Greening cities, investing in urban bike lanes rather than new roads, and making plant-based foods cheaper and easier to access than ultra-processed foods. This is a doctor’s prescription for a healthier planet. As climate negotiators at Glasgow’s COP26 conference remain locked in debate over the big-picture ambition of targets for global CO2 emissions reductions, and how to finance them, health advocates are trying to raise the profile of climate policies that would yield far-reaching knock-on benefits to the health of almost everyone on earth – but particularly for children, women and people living in some the poorest nations of the world. “We have sacrificed children all around the world to air pollution,” said Rosamund Kissi-Debrah, noting that some 500,000 children a year die from air pollution. Kissi-Debrah was speaking at the COP26 “Triple Win Scenario” event on Friday, co-sponsored by the WHO and the World Resources Institute. Kissi-Debrah’s 11-year-old girl daughter, Ella, was one of those victims. But her death from severe asthma in 2013 set a precedent: it was the first to be recognised by a court anywhere in the world as air-pollution induced. "We have sacrificed children all around the world to #airpollution" – caused by the same sources of #climatechange: Rosamund Kissi-Debrah, mother of 9-year-old Ella at #COP26. Ella's death from #dirtyair was the first to be recognized by a court in 2020: https://t.co/mf8LyLAsmb — Health Policy Watch – Global Health News Reporting (@HealthPolicyW) November 5, 2021 Like many Londoners, and many more urban dwellers in low- and middle-income cities around the world, Ella had lived in a heavily trafficked and heavily polluted neighbourhood. Shifting travel to greener modes, greening cities with more trees and making cities more walkable are among the climate strategies that health forces are advocating, and could all make a difference to the next generation. “Be serious, stop burning fossil fuels because those fossil fuels go into the air and into my lungs and yours. When you think about the planet, think about a couple of little, pink lungs,” said Dr Maria Neira, Director of the Department of Public Health, Climate & Environment, at the event. She noted that some 90% of the world’s population is exposed to unhealthy air pollution levels, leading to seven million deaths a year. Children among those worst affected The COVID-19 pandemic and climate change have created a perfect storm for increased malnutrition, child wasting and stunting, and maternal anaemia in parts of Africa. The fact that children are among those worst affected by climate change is underscored by a new review of the knowledge about climate change on child health, published by the Lancet on Sunday. “Present and future generations of children bear and will continue to bear an unacceptably high disease burden from climate change,” states the review’s authors, a group of Swedish experts from the Karolinksa Institute and elsewhere. “Through its far-reaching impact on all parts of society, climate change will challenge the very essence of children’s rights to survival, good health, wellbeing, education, and nutrition as enshrined by the Convention on the Rights of the Child and emphasised in the UN Sustainable Development Goals,” they note. “Climate change threatens to exaggerate the vulnerabilities of children and other populations at risk and could substantially hamper future progress and possibly even reverse the improvements made in child survival and wellbeing during recent decades,” concludes the review, suggesting that climate change needs to be better integrated into the SDG goals that cover children’s health overall.” Glasgow moment for health advocates Woman receives food assistance after widespread flooding the Horn of Africa and East Africa in 2020, linked by meterologists to climate change. But air pollution is only one of a range of ways in which our addiction to fossil fuels is delivering a double whammy to health – and children’s health in particular. Other, even more direct impacts include deaths and illness from extreme heat, storms, flooding, fires and drought. In addition, reduced food production capacity, an expanding geographic range for many infectious diseases, and increasing risk of new animal-borne diseases leaping from the wild to burgeoning cities – as SARS-CoV2 did – are imminent threats too. Given the rapid pace of climate change, “it won’t be long before the entire population of the world is affected, directly or indirectly,” said Julia Gillard, chair of the board of the UK-based philanthropy, Wellcome Trust and former Australian Prime Minister. Gillard was speaking at the COP26 “Global Conference on Health and Climate Change,” co-hosted by the World Health Organization (WHO) in Glasgow on Saturday. At the conference, co-sponsored by Wellcome, three UK-based universities and civil society groups, speakers warned of the burgeoning global health crisis that would result from inaction on climate change. “We are used to talking about climate as an environmental challenge, an economic challenge, an equity challenge. But it is also one of the most urgent health challenges facing us all today,” said Gillard. #Breaking #COP26: Health and Climate Experts Warn of Climate-Related Health Crisis https://t.co/kLWSb4Ilkc @JuliaGillard @DrTedros @WHO @Centre @JeniMiller @GCUclimatejust @jafryt @DrMariaNeira — Global Climate and Health Alliance (@GCHAlliance) November 6, 2021 Integrated policies not just global goals Sir Andy Haines, Professor of Environmental Change and Public Health at the London School of Hygiene and Tropical Medicine, speaking at the COP26 Climate and Health Summit. Tackling the root sources of climate change more rapidly can generate immediate savings for health systems and societies. But that will require not only big picture targets but a complete rethinking of policies, regulations, taxes and finance incentives at national and local levels, experts at the conference pointed out. “We need people to work together for integrated solutions,” said Professor Andy Haines of the London School of Hygiene and Tropical Medicine, who has written extensively on the planetary limits of not only temperature but also water, agricultural and forest ecosystems, which humankind needs to preserve to survive and thrive. Integration means recognising, for instance, that “the minister of transport is probably more a minister of health than the minister of health”, said Richard Smith, president of the UK Health Alliance on Climate Change. Commitment to ending financing for fossil fuel Twenty-six countries, including the US, UK, Canada and Italy, as well as the European Investment Bank and the French development agency, Agence Française de Développement, signed a commitment late last week to “end new direct public support for the international unabated fossil fuel energy sector by the end of 2022, except in limited and clearly defined circumstances that are consistent with a 1.5°C warming limit and the goals of the Paris Agreement”. The signatories also committed to prioritising their support “fully towards the clean energy transition”, using their resources to “enhance what can be delivered by the private sector”. They also commit to trying to persuade other governments, export credit agencies and public finance institutions to implement similar commitments into COP27 and beyond. According to WHO climate scientist Dr Diarmid Campell-Lendrum, $5.9 trillion is spent on direct and indirect subsidies to the fossil fuel industry each year. “We need to stop spending money on the wrong things and start spending it on the right things,” said Campbell-Lendrum, who cycled 1,600 km from Geneva to the Glasgow summit to drive home his point. He bore with him a letter calling for more climate action, signed by some 300 organisations, representing some 45 million health care professionals around the world. In London, Campbell-Lendrum was met by a raft of other climate cycle enthusiasts who continued the relay, getting the letter to Glasgow, where it was delivered to the COP26 leadership. https://twitter.com/i/status/1454817969276690436 Image Credits: Christine Olson/Flickr, IFRC, Paul Chappells. The African Medicines Agency Countdown 05/11/2021 Editorial team Thirty-nine of the African Union’s 55 member states have now signed and/or ratified the African Medicines Agency Treaty, as of 6 July 2024, with Kenya, the Democratic Republic of Congo and Cape Verde amongst the latest to swing behind the treaty. As the countdown for other nations to sign continues, Health Policy Watch is tracking progress on our AMA Countdown, website developed in collaboration with the African Medicines Agency Treaty Alliance. Here you can find the latest data on who has signed the treaty, ratified the treaty – and who is yet to sign – as well as links to sources and resources related to the African Medicines Agency Treaty process: Multimedia available for download: Find up-to-date infographics describing what countries have signed, signed and ratified, and signed, ratified and deposited the AMA treaty – in .png and interactive formats available for embed or download. African Union FAQs on the AMA Treaty Click to access 41269-doc-AMA_FAQs_rev.pdf Official African Union infographic repository Multilingual links to the AMA Treaty: The AMA Treaty in English: The AMA Treaty in French: The AMA Treaty in Arabic: The AMA Treaty in Portuguese: African Medicines Agency Treaty Alliance: AMATA joint statement, 5 November 2021, at the time that the AMA Treaty came into force. Breaking: Majority of African Countries Have Now Signed African Medicines Agency Treaty, Enabling Better Access to Newer, Safer Medicines 05/11/2021 Kerry Cullinan & Elaine Ruth Fletcher Pharmacy at Zouan health centre, Cote d’Ivoire; creation of an African Medicines Agency is intended to streamline regulatory approvals, improving quality and availability of medicines. Signatories to the new African Medicines Agency Treaty have now reached 28 countries – more than half of the African Union’s 55 member states – with the balance tipping as Uganda signed the treaty instrument last week. On Friday, 5 November, after more than a decade of preparations, the African Medicine Agency (AMA) treaty also came into force officially – clearing the way for the AMA to begin operations as a formal entity. And support for the treaty seemed to be picking up momentum with Cote d’Ivoire also signing the treaty on 29 October just ahead of Uganda’s signature on 3 November. See all the data here on our special website: African Medicines Agency Countdown, where we will be tracking all the latest developments in stories and interactive infographics. Despite the building support for the AMA, it will take more time, money and most of all – signatories from more of Africa’s powerhouse nations – to ensure that the new AMA entity can fulfill its mandate to ensure more rapid access to safer, newer and higher quality medicines across the continent. South Africa, Nigeria, Kenya and Ethiopia are among the 27 AU member states that have yet to even sign, yet alone ratify, the treaty document, which was first approved by the African Union in 2019. But with the AMA treaty coming into full force, exactly one month after the first 15 countries ratified and deposited the treaty instrument, no one is losing time. An AU meeting, set for February 2022, will select a country to host the new AMA headquarter and operations. Following that, formal structures will have to be set up and money raised to support its many crucial tasks. While a long road remains, AMA special envoy, Michel Sidibé said that the treaty’s entry into force is a ‘historic moment’. Historic moment today with the entry into force of the African Medicines Agency treaty. Bravo to the member states! We are grateful to President @AUC_MoussaFaki for his inspirational leadership and thank @AmiraDSA, @NEPAD_Mayaki, @DrTedros and all partners for their support. pic.twitter.com/a9IFitbFWz — Michel Sidibé (@MichelSidibe) November 5, 2021 COVID pandemic has sharpened the need for a continent-wide medicines agency The African Medicines Agency Treaty Alliance (AMATA), a coalition of patient civil society groups, academic institutions and industry, congratulated the first 15 African countries to ratify and deposit the treaty. AMATA called upon all other AU member states to quickly follow suit. Some 28 countries have so far signed the treaty, the majority in western Africa. Among those signatories, 10 have yet to ratify the treaty and three have still to deposit their ratifications with the African Union. The COVID-19 pandemic has sharpened the need for a continental agency that is able to fast-track approval for crucial vaccines and other medical products, AMATA said in its satement Friday: “COVID-19 has demonstrated that health security will only be achieved through concerted efforts and cross-border collaboration. “We call on all AU Heads of State to seize this historic opportunity to have one regulatory affairs oversight across the continent to enhance national, regional and continental regulation of medical products and oversee rapid and effective market authorization of safe, quality, effective and accessible medical products, for the good of all African people.” AMATA also called on the AMA Governing Board to rapidly move to put into place: A solid governance structure; Robust regulatory infrastructures; Adequate financial and human resources. AMATA also asked that the AMA governing board “recognise patients as key partners in the management structures and development of the agency”. Need for more AMA treaty signatories and quick operationalization Dr Maïmouna Diop Ly , AMATA board member AMATA executive board member Dr Maïmouna Diop Ly told Health Policy Watch that three critical tasks lay ahead in order for the agency to be successful. “There is a need to ensure that a critical number of countries sign the treaty to enable a quick operationalization of AMA,” said Diop Ly. “The statutory organs – the conference of state parties, governing board, secretariat and technical committees – should be put in place to ensure its functionality,” she added. “Finally, the allocation of adequate resources from countries’ contribution and partners is needed and should be part of the discussion of 2022 national budgets,” concluded Diop Ly, who is a health specialist with the African Development Bank and an advisor to the Senegal-based public health NGO, Speak-Up Africa. Potential lies to reduce market barriers to new medicines and fight fakes Andy Gray, senior lecturer in pharmacology at the University of KwaZulu-Natal in South Africa, said that AMA’s greatest potential lies “in the field of harmonisation of regulatory systems, which should reduce the barriers to market entry in Africa”. “The AMA is not intended to be a supranational regulator, and will not make decisions in the way the EMA does, but it could help in bringing national medicines regulatory authorities together, simplifying systems and reducing redundancy,” explained Gray. Over a quarter of the continent’s medicines are substandard or falsified, while only 2% are produced in Africa, according to AUDA. Through the harmonized regulatory framework, norms and standards, AMA will enable better access and equity to safe, quality medicine, medical products to African patients. This will also bring access to new and innovative technology for vaccines, medicine, medical devices, etc that will serve patients. The huge challenge of expanding universal health coverage – including health insurance – can also be advanced more systematically, with the support of new AMA structures – which should ease affordable access to medications, experts say. Proposed nearly a decade ago A continental medicine agency was first proposed a decade ago, and African Union member states adopted the AMA treaty almost three years ago. But the treaty could only be enforced once 15 AU member states had formally notified the AU Commission that they had ratified the treaty. This happened 30 days ago, when Cameroon became the 15th country to do so, thus setting in motion the formal establishment of the agency. The main aims of the AMA, as listed by the AU Development Agency (AUDA), are to: Support the growth of local pharmaceutical production Evaluate medical products to treat priority diseases identified by the AU Regularly inspect, coordinate and share information about products that are authorised for marketing. Coordinate reviews of clinical trial applications for vaccines and assess product dossiers such as bio-similars. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites. Collaborate with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs) to identify substandard and fake medical products Develop common standards and regulations, which will ensure that the continent’s legislation is harmonised. Responding to the medical crisis caused by COVID-19, the International Alliance of Patients’ Organizations (IAPO) helped to set up a lobby group, the African Medicines Agency Treaty Alliance (AMATA), to push for the speedier establishment of the agency. AMA ‘critically important’ says United States Meanwhile, Jessie Lapenn, the US Ambassador to the African Union, described the AMA as critical important to improving health security in Africa. “The AMA will be another critically important African institution that is part of the broader architecture that will be crucial for strengthening the continent’s health security,” Lapenn said at Thursday’s Africa Centres for Disease Control media briefing. “The US government and US private sector are very much looking forward to collaboration with AMA,” Lapenn added. Along with Cameroon, other countries to have both ratified the AMA and “deposited the instrument of ratification” at the AU (a letter from the head of state informing it of ratification) are predominantly west and north African, and/ Francophone nations, including: Algeria, Benin, Burkina Faso, Gabon, Guinea, Mali, Mauritius, Niger, Seychelles, and Sierra Leone. That may be due, in part, to the fact that the AU’s Special Envoy on the AMA is Michel Sidibé, Mali’s ex-Minister of Health. Now it will be up to southern, eastern and northern Africa to catch up – although Rwanda, Namibia and Zimbabwe have also been among the first to have ratified and deposited the treaty instrument. They were followed by Uganda, which signed the treaty on November 3. https://twitter.com/sabrinah_nati/status/1456617479430709249 Pharma groups welcome AMA’s creation Pharmaceutical companies have long complained about how complicated it is to get medicines approved in Africa and how long it takes – particularly in comparison to Europe, which processes applications via a central European Medicines Agency (EMA). A significant number of African countries’ national medicine regulatory authorities are under-resourced and lacking in expertise. Greg Perry, Assistant Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), welcomed the landmark moment where the treaty has now come into force, describing it as “one step closer to achieving a continent-wide regulatory agency”. “We look forward to the full implementation of the AMA, which will be a game-changer for all Africans to access safe, effective and quality medical products in a timely manner,” said Perry. -Updated on 8 November, 2021 Image Credits: James Oatway/IMF – Healthcare Focus , ©EC/ECHO/Anouk Delafortrie, LinkedIn. Pfizer Says New Anti-Viral Drug Combination Cuts Risks Of Serious COVID-19 By 89% 05/11/2021 Aishwarya Tendolkar Pfizer’s experimental pill works by inhibiting replication of SARS-CoV2 virus. Pfizer Friday announced that its experimental COVID-19 oral antiviral drug PAXLOVID™ reduced risks of hospitalization and death by 89% among patients who received the drug within the first three days of their illness. The company said it had stopped its Phase 2/3 trial on the drug owing to the success rate seen in an interim analysis of 1,219 adults enrolled in the study – who also had chronic health conditions placing them at higher risk of severe COVID. Pfizer is the second pharma firm, after Merck Sharp & Dohme (Merck), to announce highly promising results for an oral drug treatment that reduces serious COVID-19 illness – although the Pfizer results were even more stunning. PAXLOVID™ has the potential to eliminate up to nine out of ten hospitalizations, Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said in a press release. It’s a gamechanger,” Pfizer CEO Albert Bourla told @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” If approved for emergency use by the United States Food and Drug Administration (US FDA), PAXLOVID™ would become the first oral COVID antiviral of its kind. The novel treatment includes a newly- designed SARS-CoV-2-3CL protease inhibitor used in combination with a common anti-HIV drug, ritonavir. Bourla told CNBC that the filing for the drug is expected to be submitted before the U.S. Thanksgiving holiday on Nov. 25. “It’s a gamechanger,” Pfizer CEO Albert Bourla tells @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” https://t.co/IUYCAbZUu9 pic.twitter.com/QTFfJBizPs — CNBC (@CNBC) November 5, 2021 Pfizer’s results more impressive than Merck’s The Pfizer announcement follows Merck’s announcement last month that it’s new oral pill, molnupiravir, had reduced the risks of hospitalization and death by some 50% among people with mild or moderate COVID. The Merck pill, which was approved by UK regulators last week, introduces errors into the genetic code of the SARS-CoV2 virus that it targets, slowing virus replication. Pfizer’s reported results were even more impressive, however. Based on a primary analysis of interim data from 1,219 at-risk adults who were enrolled by September 29, 2021, only three people administered the drug within three days of sympton onset were hospitalized through day 28 of their illness, with no deaths. In the control group, 27 people were hospitalized, with seven subsequent deaths. When the company decided to stop recruiting more patients, their enrollment had reached 70 percent of the planned 3,000 patients across North and South America, Europe, Africa, and Asia. Pfizer drug is based upon a novel protease inhibitor, PF-07321332, that blocks the activity of the enzyme that the coronavirus needs to replicate. Co-administration of ritonavir means that protease inhibitor remains active in the body for longer periods of time to combat the virus. Treatment involves the administration of three PAXLOVID™ pills, twice a day, for five days. Pfizer says it will also ensure equitable access to new drug formulation While Merck’s molnupiravir pill is set to be licensed for generic production in most low- and middle-income countries, Pfizer said that it will offer PAXLOVID™ worldwide, through a tiered pricing approach – while maintaining control of its IP. Last week, Merck and the Medicines Patent Pool signed an agreement that paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell their treatment molnupiravir at discounted prices to more than 105 countries worldwide, once the drug receives approval by the World Health Organization. Pfizer, in contrast, said that its tiered pricing would be “based on the income level of each country to promote equity of access across the globe. “High and upper-middle income countries will pay more than lower income countries,” Pfizer said, adding that it had already entered into advance purchase agreements with “multiple countries and is in negotiations with several others” – without naming which. “Pfizer has also begun and will continue to invest up to approximately $1 billion to support the manufacturing and distribution of this investigational treatment, including exploring potential contract manufacturing options to help ensure access across low- and middle-income countries, pending regulatory authorization.” Image Credits: Wikimedia Commons, peterschreiber.media/Shutterstock . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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Children’s Health Hit Hardest by Climate Change – but Cleaner Air, Greener Cities and Healthier Foods Can Create Cascade of Benefits 07/11/2021 Elaine Ruth Fletcher Rosamund Kissi-Debrah, mother of 11-year Ella, whose 2013 death from severe asthma was the first to be recognized by a court as caused by air pollution. Greening cities, investing in urban bike lanes rather than new roads, and making plant-based foods cheaper and easier to access than ultra-processed foods. This is a doctor’s prescription for a healthier planet. As climate negotiators at Glasgow’s COP26 conference remain locked in debate over the big-picture ambition of targets for global CO2 emissions reductions, and how to finance them, health advocates are trying to raise the profile of climate policies that would yield far-reaching knock-on benefits to the health of almost everyone on earth – but particularly for children, women and people living in some the poorest nations of the world. “We have sacrificed children all around the world to air pollution,” said Rosamund Kissi-Debrah, noting that some 500,000 children a year die from air pollution. Kissi-Debrah was speaking at the COP26 “Triple Win Scenario” event on Friday, co-sponsored by the WHO and the World Resources Institute. Kissi-Debrah’s 11-year-old girl daughter, Ella, was one of those victims. But her death from severe asthma in 2013 set a precedent: it was the first to be recognised by a court anywhere in the world as air-pollution induced. "We have sacrificed children all around the world to #airpollution" – caused by the same sources of #climatechange: Rosamund Kissi-Debrah, mother of 9-year-old Ella at #COP26. Ella's death from #dirtyair was the first to be recognized by a court in 2020: https://t.co/mf8LyLAsmb — Health Policy Watch – Global Health News Reporting (@HealthPolicyW) November 5, 2021 Like many Londoners, and many more urban dwellers in low- and middle-income cities around the world, Ella had lived in a heavily trafficked and heavily polluted neighbourhood. Shifting travel to greener modes, greening cities with more trees and making cities more walkable are among the climate strategies that health forces are advocating, and could all make a difference to the next generation. “Be serious, stop burning fossil fuels because those fossil fuels go into the air and into my lungs and yours. When you think about the planet, think about a couple of little, pink lungs,” said Dr Maria Neira, Director of the Department of Public Health, Climate & Environment, at the event. She noted that some 90% of the world’s population is exposed to unhealthy air pollution levels, leading to seven million deaths a year. Children among those worst affected The COVID-19 pandemic and climate change have created a perfect storm for increased malnutrition, child wasting and stunting, and maternal anaemia in parts of Africa. The fact that children are among those worst affected by climate change is underscored by a new review of the knowledge about climate change on child health, published by the Lancet on Sunday. “Present and future generations of children bear and will continue to bear an unacceptably high disease burden from climate change,” states the review’s authors, a group of Swedish experts from the Karolinksa Institute and elsewhere. “Through its far-reaching impact on all parts of society, climate change will challenge the very essence of children’s rights to survival, good health, wellbeing, education, and nutrition as enshrined by the Convention on the Rights of the Child and emphasised in the UN Sustainable Development Goals,” they note. “Climate change threatens to exaggerate the vulnerabilities of children and other populations at risk and could substantially hamper future progress and possibly even reverse the improvements made in child survival and wellbeing during recent decades,” concludes the review, suggesting that climate change needs to be better integrated into the SDG goals that cover children’s health overall.” Glasgow moment for health advocates Woman receives food assistance after widespread flooding the Horn of Africa and East Africa in 2020, linked by meterologists to climate change. But air pollution is only one of a range of ways in which our addiction to fossil fuels is delivering a double whammy to health – and children’s health in particular. Other, even more direct impacts include deaths and illness from extreme heat, storms, flooding, fires and drought. In addition, reduced food production capacity, an expanding geographic range for many infectious diseases, and increasing risk of new animal-borne diseases leaping from the wild to burgeoning cities – as SARS-CoV2 did – are imminent threats too. Given the rapid pace of climate change, “it won’t be long before the entire population of the world is affected, directly or indirectly,” said Julia Gillard, chair of the board of the UK-based philanthropy, Wellcome Trust and former Australian Prime Minister. Gillard was speaking at the COP26 “Global Conference on Health and Climate Change,” co-hosted by the World Health Organization (WHO) in Glasgow on Saturday. At the conference, co-sponsored by Wellcome, three UK-based universities and civil society groups, speakers warned of the burgeoning global health crisis that would result from inaction on climate change. “We are used to talking about climate as an environmental challenge, an economic challenge, an equity challenge. But it is also one of the most urgent health challenges facing us all today,” said Gillard. #Breaking #COP26: Health and Climate Experts Warn of Climate-Related Health Crisis https://t.co/kLWSb4Ilkc @JuliaGillard @DrTedros @WHO @Centre @JeniMiller @GCUclimatejust @jafryt @DrMariaNeira — Global Climate and Health Alliance (@GCHAlliance) November 6, 2021 Integrated policies not just global goals Sir Andy Haines, Professor of Environmental Change and Public Health at the London School of Hygiene and Tropical Medicine, speaking at the COP26 Climate and Health Summit. Tackling the root sources of climate change more rapidly can generate immediate savings for health systems and societies. But that will require not only big picture targets but a complete rethinking of policies, regulations, taxes and finance incentives at national and local levels, experts at the conference pointed out. “We need people to work together for integrated solutions,” said Professor Andy Haines of the London School of Hygiene and Tropical Medicine, who has written extensively on the planetary limits of not only temperature but also water, agricultural and forest ecosystems, which humankind needs to preserve to survive and thrive. Integration means recognising, for instance, that “the minister of transport is probably more a minister of health than the minister of health”, said Richard Smith, president of the UK Health Alliance on Climate Change. Commitment to ending financing for fossil fuel Twenty-six countries, including the US, UK, Canada and Italy, as well as the European Investment Bank and the French development agency, Agence Française de Développement, signed a commitment late last week to “end new direct public support for the international unabated fossil fuel energy sector by the end of 2022, except in limited and clearly defined circumstances that are consistent with a 1.5°C warming limit and the goals of the Paris Agreement”. The signatories also committed to prioritising their support “fully towards the clean energy transition”, using their resources to “enhance what can be delivered by the private sector”. They also commit to trying to persuade other governments, export credit agencies and public finance institutions to implement similar commitments into COP27 and beyond. According to WHO climate scientist Dr Diarmid Campell-Lendrum, $5.9 trillion is spent on direct and indirect subsidies to the fossil fuel industry each year. “We need to stop spending money on the wrong things and start spending it on the right things,” said Campbell-Lendrum, who cycled 1,600 km from Geneva to the Glasgow summit to drive home his point. He bore with him a letter calling for more climate action, signed by some 300 organisations, representing some 45 million health care professionals around the world. In London, Campbell-Lendrum was met by a raft of other climate cycle enthusiasts who continued the relay, getting the letter to Glasgow, where it was delivered to the COP26 leadership. https://twitter.com/i/status/1454817969276690436 Image Credits: Christine Olson/Flickr, IFRC, Paul Chappells. The African Medicines Agency Countdown 05/11/2021 Editorial team Thirty-nine of the African Union’s 55 member states have now signed and/or ratified the African Medicines Agency Treaty, as of 6 July 2024, with Kenya, the Democratic Republic of Congo and Cape Verde amongst the latest to swing behind the treaty. As the countdown for other nations to sign continues, Health Policy Watch is tracking progress on our AMA Countdown, website developed in collaboration with the African Medicines Agency Treaty Alliance. Here you can find the latest data on who has signed the treaty, ratified the treaty – and who is yet to sign – as well as links to sources and resources related to the African Medicines Agency Treaty process: Multimedia available for download: Find up-to-date infographics describing what countries have signed, signed and ratified, and signed, ratified and deposited the AMA treaty – in .png and interactive formats available for embed or download. African Union FAQs on the AMA Treaty Click to access 41269-doc-AMA_FAQs_rev.pdf Official African Union infographic repository Multilingual links to the AMA Treaty: The AMA Treaty in English: The AMA Treaty in French: The AMA Treaty in Arabic: The AMA Treaty in Portuguese: African Medicines Agency Treaty Alliance: AMATA joint statement, 5 November 2021, at the time that the AMA Treaty came into force. Breaking: Majority of African Countries Have Now Signed African Medicines Agency Treaty, Enabling Better Access to Newer, Safer Medicines 05/11/2021 Kerry Cullinan & Elaine Ruth Fletcher Pharmacy at Zouan health centre, Cote d’Ivoire; creation of an African Medicines Agency is intended to streamline regulatory approvals, improving quality and availability of medicines. Signatories to the new African Medicines Agency Treaty have now reached 28 countries – more than half of the African Union’s 55 member states – with the balance tipping as Uganda signed the treaty instrument last week. On Friday, 5 November, after more than a decade of preparations, the African Medicine Agency (AMA) treaty also came into force officially – clearing the way for the AMA to begin operations as a formal entity. And support for the treaty seemed to be picking up momentum with Cote d’Ivoire also signing the treaty on 29 October just ahead of Uganda’s signature on 3 November. See all the data here on our special website: African Medicines Agency Countdown, where we will be tracking all the latest developments in stories and interactive infographics. Despite the building support for the AMA, it will take more time, money and most of all – signatories from more of Africa’s powerhouse nations – to ensure that the new AMA entity can fulfill its mandate to ensure more rapid access to safer, newer and higher quality medicines across the continent. South Africa, Nigeria, Kenya and Ethiopia are among the 27 AU member states that have yet to even sign, yet alone ratify, the treaty document, which was first approved by the African Union in 2019. But with the AMA treaty coming into full force, exactly one month after the first 15 countries ratified and deposited the treaty instrument, no one is losing time. An AU meeting, set for February 2022, will select a country to host the new AMA headquarter and operations. Following that, formal structures will have to be set up and money raised to support its many crucial tasks. While a long road remains, AMA special envoy, Michel Sidibé said that the treaty’s entry into force is a ‘historic moment’. Historic moment today with the entry into force of the African Medicines Agency treaty. Bravo to the member states! We are grateful to President @AUC_MoussaFaki for his inspirational leadership and thank @AmiraDSA, @NEPAD_Mayaki, @DrTedros and all partners for their support. pic.twitter.com/a9IFitbFWz — Michel Sidibé (@MichelSidibe) November 5, 2021 COVID pandemic has sharpened the need for a continent-wide medicines agency The African Medicines Agency Treaty Alliance (AMATA), a coalition of patient civil society groups, academic institutions and industry, congratulated the first 15 African countries to ratify and deposit the treaty. AMATA called upon all other AU member states to quickly follow suit. Some 28 countries have so far signed the treaty, the majority in western Africa. Among those signatories, 10 have yet to ratify the treaty and three have still to deposit their ratifications with the African Union. The COVID-19 pandemic has sharpened the need for a continental agency that is able to fast-track approval for crucial vaccines and other medical products, AMATA said in its satement Friday: “COVID-19 has demonstrated that health security will only be achieved through concerted efforts and cross-border collaboration. “We call on all AU Heads of State to seize this historic opportunity to have one regulatory affairs oversight across the continent to enhance national, regional and continental regulation of medical products and oversee rapid and effective market authorization of safe, quality, effective and accessible medical products, for the good of all African people.” AMATA also called on the AMA Governing Board to rapidly move to put into place: A solid governance structure; Robust regulatory infrastructures; Adequate financial and human resources. AMATA also asked that the AMA governing board “recognise patients as key partners in the management structures and development of the agency”. Need for more AMA treaty signatories and quick operationalization Dr Maïmouna Diop Ly , AMATA board member AMATA executive board member Dr Maïmouna Diop Ly told Health Policy Watch that three critical tasks lay ahead in order for the agency to be successful. “There is a need to ensure that a critical number of countries sign the treaty to enable a quick operationalization of AMA,” said Diop Ly. “The statutory organs – the conference of state parties, governing board, secretariat and technical committees – should be put in place to ensure its functionality,” she added. “Finally, the allocation of adequate resources from countries’ contribution and partners is needed and should be part of the discussion of 2022 national budgets,” concluded Diop Ly, who is a health specialist with the African Development Bank and an advisor to the Senegal-based public health NGO, Speak-Up Africa. Potential lies to reduce market barriers to new medicines and fight fakes Andy Gray, senior lecturer in pharmacology at the University of KwaZulu-Natal in South Africa, said that AMA’s greatest potential lies “in the field of harmonisation of regulatory systems, which should reduce the barriers to market entry in Africa”. “The AMA is not intended to be a supranational regulator, and will not make decisions in the way the EMA does, but it could help in bringing national medicines regulatory authorities together, simplifying systems and reducing redundancy,” explained Gray. Over a quarter of the continent’s medicines are substandard or falsified, while only 2% are produced in Africa, according to AUDA. Through the harmonized regulatory framework, norms and standards, AMA will enable better access and equity to safe, quality medicine, medical products to African patients. This will also bring access to new and innovative technology for vaccines, medicine, medical devices, etc that will serve patients. The huge challenge of expanding universal health coverage – including health insurance – can also be advanced more systematically, with the support of new AMA structures – which should ease affordable access to medications, experts say. Proposed nearly a decade ago A continental medicine agency was first proposed a decade ago, and African Union member states adopted the AMA treaty almost three years ago. But the treaty could only be enforced once 15 AU member states had formally notified the AU Commission that they had ratified the treaty. This happened 30 days ago, when Cameroon became the 15th country to do so, thus setting in motion the formal establishment of the agency. The main aims of the AMA, as listed by the AU Development Agency (AUDA), are to: Support the growth of local pharmaceutical production Evaluate medical products to treat priority diseases identified by the AU Regularly inspect, coordinate and share information about products that are authorised for marketing. Coordinate reviews of clinical trial applications for vaccines and assess product dossiers such as bio-similars. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites. Collaborate with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs) to identify substandard and fake medical products Develop common standards and regulations, which will ensure that the continent’s legislation is harmonised. Responding to the medical crisis caused by COVID-19, the International Alliance of Patients’ Organizations (IAPO) helped to set up a lobby group, the African Medicines Agency Treaty Alliance (AMATA), to push for the speedier establishment of the agency. AMA ‘critically important’ says United States Meanwhile, Jessie Lapenn, the US Ambassador to the African Union, described the AMA as critical important to improving health security in Africa. “The AMA will be another critically important African institution that is part of the broader architecture that will be crucial for strengthening the continent’s health security,” Lapenn said at Thursday’s Africa Centres for Disease Control media briefing. “The US government and US private sector are very much looking forward to collaboration with AMA,” Lapenn added. Along with Cameroon, other countries to have both ratified the AMA and “deposited the instrument of ratification” at the AU (a letter from the head of state informing it of ratification) are predominantly west and north African, and/ Francophone nations, including: Algeria, Benin, Burkina Faso, Gabon, Guinea, Mali, Mauritius, Niger, Seychelles, and Sierra Leone. That may be due, in part, to the fact that the AU’s Special Envoy on the AMA is Michel Sidibé, Mali’s ex-Minister of Health. Now it will be up to southern, eastern and northern Africa to catch up – although Rwanda, Namibia and Zimbabwe have also been among the first to have ratified and deposited the treaty instrument. They were followed by Uganda, which signed the treaty on November 3. https://twitter.com/sabrinah_nati/status/1456617479430709249 Pharma groups welcome AMA’s creation Pharmaceutical companies have long complained about how complicated it is to get medicines approved in Africa and how long it takes – particularly in comparison to Europe, which processes applications via a central European Medicines Agency (EMA). A significant number of African countries’ national medicine regulatory authorities are under-resourced and lacking in expertise. Greg Perry, Assistant Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), welcomed the landmark moment where the treaty has now come into force, describing it as “one step closer to achieving a continent-wide regulatory agency”. “We look forward to the full implementation of the AMA, which will be a game-changer for all Africans to access safe, effective and quality medical products in a timely manner,” said Perry. -Updated on 8 November, 2021 Image Credits: James Oatway/IMF – Healthcare Focus , ©EC/ECHO/Anouk Delafortrie, LinkedIn. Pfizer Says New Anti-Viral Drug Combination Cuts Risks Of Serious COVID-19 By 89% 05/11/2021 Aishwarya Tendolkar Pfizer’s experimental pill works by inhibiting replication of SARS-CoV2 virus. Pfizer Friday announced that its experimental COVID-19 oral antiviral drug PAXLOVID™ reduced risks of hospitalization and death by 89% among patients who received the drug within the first three days of their illness. The company said it had stopped its Phase 2/3 trial on the drug owing to the success rate seen in an interim analysis of 1,219 adults enrolled in the study – who also had chronic health conditions placing them at higher risk of severe COVID. Pfizer is the second pharma firm, after Merck Sharp & Dohme (Merck), to announce highly promising results for an oral drug treatment that reduces serious COVID-19 illness – although the Pfizer results were even more stunning. PAXLOVID™ has the potential to eliminate up to nine out of ten hospitalizations, Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said in a press release. It’s a gamechanger,” Pfizer CEO Albert Bourla told @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” If approved for emergency use by the United States Food and Drug Administration (US FDA), PAXLOVID™ would become the first oral COVID antiviral of its kind. The novel treatment includes a newly- designed SARS-CoV-2-3CL protease inhibitor used in combination with a common anti-HIV drug, ritonavir. Bourla told CNBC that the filing for the drug is expected to be submitted before the U.S. Thanksgiving holiday on Nov. 25. “It’s a gamechanger,” Pfizer CEO Albert Bourla tells @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” https://t.co/IUYCAbZUu9 pic.twitter.com/QTFfJBizPs — CNBC (@CNBC) November 5, 2021 Pfizer’s results more impressive than Merck’s The Pfizer announcement follows Merck’s announcement last month that it’s new oral pill, molnupiravir, had reduced the risks of hospitalization and death by some 50% among people with mild or moderate COVID. The Merck pill, which was approved by UK regulators last week, introduces errors into the genetic code of the SARS-CoV2 virus that it targets, slowing virus replication. Pfizer’s reported results were even more impressive, however. Based on a primary analysis of interim data from 1,219 at-risk adults who were enrolled by September 29, 2021, only three people administered the drug within three days of sympton onset were hospitalized through day 28 of their illness, with no deaths. In the control group, 27 people were hospitalized, with seven subsequent deaths. When the company decided to stop recruiting more patients, their enrollment had reached 70 percent of the planned 3,000 patients across North and South America, Europe, Africa, and Asia. Pfizer drug is based upon a novel protease inhibitor, PF-07321332, that blocks the activity of the enzyme that the coronavirus needs to replicate. Co-administration of ritonavir means that protease inhibitor remains active in the body for longer periods of time to combat the virus. Treatment involves the administration of three PAXLOVID™ pills, twice a day, for five days. Pfizer says it will also ensure equitable access to new drug formulation While Merck’s molnupiravir pill is set to be licensed for generic production in most low- and middle-income countries, Pfizer said that it will offer PAXLOVID™ worldwide, through a tiered pricing approach – while maintaining control of its IP. Last week, Merck and the Medicines Patent Pool signed an agreement that paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell their treatment molnupiravir at discounted prices to more than 105 countries worldwide, once the drug receives approval by the World Health Organization. Pfizer, in contrast, said that its tiered pricing would be “based on the income level of each country to promote equity of access across the globe. “High and upper-middle income countries will pay more than lower income countries,” Pfizer said, adding that it had already entered into advance purchase agreements with “multiple countries and is in negotiations with several others” – without naming which. “Pfizer has also begun and will continue to invest up to approximately $1 billion to support the manufacturing and distribution of this investigational treatment, including exploring potential contract manufacturing options to help ensure access across low- and middle-income countries, pending regulatory authorization.” Image Credits: Wikimedia Commons, peterschreiber.media/Shutterstock . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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The African Medicines Agency Countdown 05/11/2021 Editorial team Thirty-nine of the African Union’s 55 member states have now signed and/or ratified the African Medicines Agency Treaty, as of 6 July 2024, with Kenya, the Democratic Republic of Congo and Cape Verde amongst the latest to swing behind the treaty. As the countdown for other nations to sign continues, Health Policy Watch is tracking progress on our AMA Countdown, website developed in collaboration with the African Medicines Agency Treaty Alliance. Here you can find the latest data on who has signed the treaty, ratified the treaty – and who is yet to sign – as well as links to sources and resources related to the African Medicines Agency Treaty process: Multimedia available for download: Find up-to-date infographics describing what countries have signed, signed and ratified, and signed, ratified and deposited the AMA treaty – in .png and interactive formats available for embed or download. African Union FAQs on the AMA Treaty Click to access 41269-doc-AMA_FAQs_rev.pdf Official African Union infographic repository Multilingual links to the AMA Treaty: The AMA Treaty in English: The AMA Treaty in French: The AMA Treaty in Arabic: The AMA Treaty in Portuguese: African Medicines Agency Treaty Alliance: AMATA joint statement, 5 November 2021, at the time that the AMA Treaty came into force. Breaking: Majority of African Countries Have Now Signed African Medicines Agency Treaty, Enabling Better Access to Newer, Safer Medicines 05/11/2021 Kerry Cullinan & Elaine Ruth Fletcher Pharmacy at Zouan health centre, Cote d’Ivoire; creation of an African Medicines Agency is intended to streamline regulatory approvals, improving quality and availability of medicines. Signatories to the new African Medicines Agency Treaty have now reached 28 countries – more than half of the African Union’s 55 member states – with the balance tipping as Uganda signed the treaty instrument last week. On Friday, 5 November, after more than a decade of preparations, the African Medicine Agency (AMA) treaty also came into force officially – clearing the way for the AMA to begin operations as a formal entity. And support for the treaty seemed to be picking up momentum with Cote d’Ivoire also signing the treaty on 29 October just ahead of Uganda’s signature on 3 November. See all the data here on our special website: African Medicines Agency Countdown, where we will be tracking all the latest developments in stories and interactive infographics. Despite the building support for the AMA, it will take more time, money and most of all – signatories from more of Africa’s powerhouse nations – to ensure that the new AMA entity can fulfill its mandate to ensure more rapid access to safer, newer and higher quality medicines across the continent. South Africa, Nigeria, Kenya and Ethiopia are among the 27 AU member states that have yet to even sign, yet alone ratify, the treaty document, which was first approved by the African Union in 2019. But with the AMA treaty coming into full force, exactly one month after the first 15 countries ratified and deposited the treaty instrument, no one is losing time. An AU meeting, set for February 2022, will select a country to host the new AMA headquarter and operations. Following that, formal structures will have to be set up and money raised to support its many crucial tasks. While a long road remains, AMA special envoy, Michel Sidibé said that the treaty’s entry into force is a ‘historic moment’. Historic moment today with the entry into force of the African Medicines Agency treaty. Bravo to the member states! We are grateful to President @AUC_MoussaFaki for his inspirational leadership and thank @AmiraDSA, @NEPAD_Mayaki, @DrTedros and all partners for their support. pic.twitter.com/a9IFitbFWz — Michel Sidibé (@MichelSidibe) November 5, 2021 COVID pandemic has sharpened the need for a continent-wide medicines agency The African Medicines Agency Treaty Alliance (AMATA), a coalition of patient civil society groups, academic institutions and industry, congratulated the first 15 African countries to ratify and deposit the treaty. AMATA called upon all other AU member states to quickly follow suit. Some 28 countries have so far signed the treaty, the majority in western Africa. Among those signatories, 10 have yet to ratify the treaty and three have still to deposit their ratifications with the African Union. The COVID-19 pandemic has sharpened the need for a continental agency that is able to fast-track approval for crucial vaccines and other medical products, AMATA said in its satement Friday: “COVID-19 has demonstrated that health security will only be achieved through concerted efforts and cross-border collaboration. “We call on all AU Heads of State to seize this historic opportunity to have one regulatory affairs oversight across the continent to enhance national, regional and continental regulation of medical products and oversee rapid and effective market authorization of safe, quality, effective and accessible medical products, for the good of all African people.” AMATA also called on the AMA Governing Board to rapidly move to put into place: A solid governance structure; Robust regulatory infrastructures; Adequate financial and human resources. AMATA also asked that the AMA governing board “recognise patients as key partners in the management structures and development of the agency”. Need for more AMA treaty signatories and quick operationalization Dr Maïmouna Diop Ly , AMATA board member AMATA executive board member Dr Maïmouna Diop Ly told Health Policy Watch that three critical tasks lay ahead in order for the agency to be successful. “There is a need to ensure that a critical number of countries sign the treaty to enable a quick operationalization of AMA,” said Diop Ly. “The statutory organs – the conference of state parties, governing board, secretariat and technical committees – should be put in place to ensure its functionality,” she added. “Finally, the allocation of adequate resources from countries’ contribution and partners is needed and should be part of the discussion of 2022 national budgets,” concluded Diop Ly, who is a health specialist with the African Development Bank and an advisor to the Senegal-based public health NGO, Speak-Up Africa. Potential lies to reduce market barriers to new medicines and fight fakes Andy Gray, senior lecturer in pharmacology at the University of KwaZulu-Natal in South Africa, said that AMA’s greatest potential lies “in the field of harmonisation of regulatory systems, which should reduce the barriers to market entry in Africa”. “The AMA is not intended to be a supranational regulator, and will not make decisions in the way the EMA does, but it could help in bringing national medicines regulatory authorities together, simplifying systems and reducing redundancy,” explained Gray. Over a quarter of the continent’s medicines are substandard or falsified, while only 2% are produced in Africa, according to AUDA. Through the harmonized regulatory framework, norms and standards, AMA will enable better access and equity to safe, quality medicine, medical products to African patients. This will also bring access to new and innovative technology for vaccines, medicine, medical devices, etc that will serve patients. The huge challenge of expanding universal health coverage – including health insurance – can also be advanced more systematically, with the support of new AMA structures – which should ease affordable access to medications, experts say. Proposed nearly a decade ago A continental medicine agency was first proposed a decade ago, and African Union member states adopted the AMA treaty almost three years ago. But the treaty could only be enforced once 15 AU member states had formally notified the AU Commission that they had ratified the treaty. This happened 30 days ago, when Cameroon became the 15th country to do so, thus setting in motion the formal establishment of the agency. The main aims of the AMA, as listed by the AU Development Agency (AUDA), are to: Support the growth of local pharmaceutical production Evaluate medical products to treat priority diseases identified by the AU Regularly inspect, coordinate and share information about products that are authorised for marketing. Coordinate reviews of clinical trial applications for vaccines and assess product dossiers such as bio-similars. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites. Collaborate with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs) to identify substandard and fake medical products Develop common standards and regulations, which will ensure that the continent’s legislation is harmonised. Responding to the medical crisis caused by COVID-19, the International Alliance of Patients’ Organizations (IAPO) helped to set up a lobby group, the African Medicines Agency Treaty Alliance (AMATA), to push for the speedier establishment of the agency. AMA ‘critically important’ says United States Meanwhile, Jessie Lapenn, the US Ambassador to the African Union, described the AMA as critical important to improving health security in Africa. “The AMA will be another critically important African institution that is part of the broader architecture that will be crucial for strengthening the continent’s health security,” Lapenn said at Thursday’s Africa Centres for Disease Control media briefing. “The US government and US private sector are very much looking forward to collaboration with AMA,” Lapenn added. Along with Cameroon, other countries to have both ratified the AMA and “deposited the instrument of ratification” at the AU (a letter from the head of state informing it of ratification) are predominantly west and north African, and/ Francophone nations, including: Algeria, Benin, Burkina Faso, Gabon, Guinea, Mali, Mauritius, Niger, Seychelles, and Sierra Leone. That may be due, in part, to the fact that the AU’s Special Envoy on the AMA is Michel Sidibé, Mali’s ex-Minister of Health. Now it will be up to southern, eastern and northern Africa to catch up – although Rwanda, Namibia and Zimbabwe have also been among the first to have ratified and deposited the treaty instrument. They were followed by Uganda, which signed the treaty on November 3. https://twitter.com/sabrinah_nati/status/1456617479430709249 Pharma groups welcome AMA’s creation Pharmaceutical companies have long complained about how complicated it is to get medicines approved in Africa and how long it takes – particularly in comparison to Europe, which processes applications via a central European Medicines Agency (EMA). A significant number of African countries’ national medicine regulatory authorities are under-resourced and lacking in expertise. Greg Perry, Assistant Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), welcomed the landmark moment where the treaty has now come into force, describing it as “one step closer to achieving a continent-wide regulatory agency”. “We look forward to the full implementation of the AMA, which will be a game-changer for all Africans to access safe, effective and quality medical products in a timely manner,” said Perry. -Updated on 8 November, 2021 Image Credits: James Oatway/IMF – Healthcare Focus , ©EC/ECHO/Anouk Delafortrie, LinkedIn. Pfizer Says New Anti-Viral Drug Combination Cuts Risks Of Serious COVID-19 By 89% 05/11/2021 Aishwarya Tendolkar Pfizer’s experimental pill works by inhibiting replication of SARS-CoV2 virus. Pfizer Friday announced that its experimental COVID-19 oral antiviral drug PAXLOVID™ reduced risks of hospitalization and death by 89% among patients who received the drug within the first three days of their illness. The company said it had stopped its Phase 2/3 trial on the drug owing to the success rate seen in an interim analysis of 1,219 adults enrolled in the study – who also had chronic health conditions placing them at higher risk of severe COVID. Pfizer is the second pharma firm, after Merck Sharp & Dohme (Merck), to announce highly promising results for an oral drug treatment that reduces serious COVID-19 illness – although the Pfizer results were even more stunning. PAXLOVID™ has the potential to eliminate up to nine out of ten hospitalizations, Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said in a press release. It’s a gamechanger,” Pfizer CEO Albert Bourla told @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” If approved for emergency use by the United States Food and Drug Administration (US FDA), PAXLOVID™ would become the first oral COVID antiviral of its kind. The novel treatment includes a newly- designed SARS-CoV-2-3CL protease inhibitor used in combination with a common anti-HIV drug, ritonavir. Bourla told CNBC that the filing for the drug is expected to be submitted before the U.S. Thanksgiving holiday on Nov. 25. “It’s a gamechanger,” Pfizer CEO Albert Bourla tells @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” https://t.co/IUYCAbZUu9 pic.twitter.com/QTFfJBizPs — CNBC (@CNBC) November 5, 2021 Pfizer’s results more impressive than Merck’s The Pfizer announcement follows Merck’s announcement last month that it’s new oral pill, molnupiravir, had reduced the risks of hospitalization and death by some 50% among people with mild or moderate COVID. The Merck pill, which was approved by UK regulators last week, introduces errors into the genetic code of the SARS-CoV2 virus that it targets, slowing virus replication. Pfizer’s reported results were even more impressive, however. Based on a primary analysis of interim data from 1,219 at-risk adults who were enrolled by September 29, 2021, only three people administered the drug within three days of sympton onset were hospitalized through day 28 of their illness, with no deaths. In the control group, 27 people were hospitalized, with seven subsequent deaths. When the company decided to stop recruiting more patients, their enrollment had reached 70 percent of the planned 3,000 patients across North and South America, Europe, Africa, and Asia. Pfizer drug is based upon a novel protease inhibitor, PF-07321332, that blocks the activity of the enzyme that the coronavirus needs to replicate. Co-administration of ritonavir means that protease inhibitor remains active in the body for longer periods of time to combat the virus. Treatment involves the administration of three PAXLOVID™ pills, twice a day, for five days. Pfizer says it will also ensure equitable access to new drug formulation While Merck’s molnupiravir pill is set to be licensed for generic production in most low- and middle-income countries, Pfizer said that it will offer PAXLOVID™ worldwide, through a tiered pricing approach – while maintaining control of its IP. Last week, Merck and the Medicines Patent Pool signed an agreement that paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell their treatment molnupiravir at discounted prices to more than 105 countries worldwide, once the drug receives approval by the World Health Organization. Pfizer, in contrast, said that its tiered pricing would be “based on the income level of each country to promote equity of access across the globe. “High and upper-middle income countries will pay more than lower income countries,” Pfizer said, adding that it had already entered into advance purchase agreements with “multiple countries and is in negotiations with several others” – without naming which. “Pfizer has also begun and will continue to invest up to approximately $1 billion to support the manufacturing and distribution of this investigational treatment, including exploring potential contract manufacturing options to help ensure access across low- and middle-income countries, pending regulatory authorization.” Image Credits: Wikimedia Commons, peterschreiber.media/Shutterstock . 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.
Breaking: Majority of African Countries Have Now Signed African Medicines Agency Treaty, Enabling Better Access to Newer, Safer Medicines 05/11/2021 Kerry Cullinan & Elaine Ruth Fletcher Pharmacy at Zouan health centre, Cote d’Ivoire; creation of an African Medicines Agency is intended to streamline regulatory approvals, improving quality and availability of medicines. Signatories to the new African Medicines Agency Treaty have now reached 28 countries – more than half of the African Union’s 55 member states – with the balance tipping as Uganda signed the treaty instrument last week. On Friday, 5 November, after more than a decade of preparations, the African Medicine Agency (AMA) treaty also came into force officially – clearing the way for the AMA to begin operations as a formal entity. And support for the treaty seemed to be picking up momentum with Cote d’Ivoire also signing the treaty on 29 October just ahead of Uganda’s signature on 3 November. See all the data here on our special website: African Medicines Agency Countdown, where we will be tracking all the latest developments in stories and interactive infographics. Despite the building support for the AMA, it will take more time, money and most of all – signatories from more of Africa’s powerhouse nations – to ensure that the new AMA entity can fulfill its mandate to ensure more rapid access to safer, newer and higher quality medicines across the continent. South Africa, Nigeria, Kenya and Ethiopia are among the 27 AU member states that have yet to even sign, yet alone ratify, the treaty document, which was first approved by the African Union in 2019. But with the AMA treaty coming into full force, exactly one month after the first 15 countries ratified and deposited the treaty instrument, no one is losing time. An AU meeting, set for February 2022, will select a country to host the new AMA headquarter and operations. Following that, formal structures will have to be set up and money raised to support its many crucial tasks. While a long road remains, AMA special envoy, Michel Sidibé said that the treaty’s entry into force is a ‘historic moment’. Historic moment today with the entry into force of the African Medicines Agency treaty. Bravo to the member states! We are grateful to President @AUC_MoussaFaki for his inspirational leadership and thank @AmiraDSA, @NEPAD_Mayaki, @DrTedros and all partners for their support. pic.twitter.com/a9IFitbFWz — Michel Sidibé (@MichelSidibe) November 5, 2021 COVID pandemic has sharpened the need for a continent-wide medicines agency The African Medicines Agency Treaty Alliance (AMATA), a coalition of patient civil society groups, academic institutions and industry, congratulated the first 15 African countries to ratify and deposit the treaty. AMATA called upon all other AU member states to quickly follow suit. Some 28 countries have so far signed the treaty, the majority in western Africa. Among those signatories, 10 have yet to ratify the treaty and three have still to deposit their ratifications with the African Union. The COVID-19 pandemic has sharpened the need for a continental agency that is able to fast-track approval for crucial vaccines and other medical products, AMATA said in its satement Friday: “COVID-19 has demonstrated that health security will only be achieved through concerted efforts and cross-border collaboration. “We call on all AU Heads of State to seize this historic opportunity to have one regulatory affairs oversight across the continent to enhance national, regional and continental regulation of medical products and oversee rapid and effective market authorization of safe, quality, effective and accessible medical products, for the good of all African people.” AMATA also called on the AMA Governing Board to rapidly move to put into place: A solid governance structure; Robust regulatory infrastructures; Adequate financial and human resources. AMATA also asked that the AMA governing board “recognise patients as key partners in the management structures and development of the agency”. Need for more AMA treaty signatories and quick operationalization Dr Maïmouna Diop Ly , AMATA board member AMATA executive board member Dr Maïmouna Diop Ly told Health Policy Watch that three critical tasks lay ahead in order for the agency to be successful. “There is a need to ensure that a critical number of countries sign the treaty to enable a quick operationalization of AMA,” said Diop Ly. “The statutory organs – the conference of state parties, governing board, secretariat and technical committees – should be put in place to ensure its functionality,” she added. “Finally, the allocation of adequate resources from countries’ contribution and partners is needed and should be part of the discussion of 2022 national budgets,” concluded Diop Ly, who is a health specialist with the African Development Bank and an advisor to the Senegal-based public health NGO, Speak-Up Africa. Potential lies to reduce market barriers to new medicines and fight fakes Andy Gray, senior lecturer in pharmacology at the University of KwaZulu-Natal in South Africa, said that AMA’s greatest potential lies “in the field of harmonisation of regulatory systems, which should reduce the barriers to market entry in Africa”. “The AMA is not intended to be a supranational regulator, and will not make decisions in the way the EMA does, but it could help in bringing national medicines regulatory authorities together, simplifying systems and reducing redundancy,” explained Gray. Over a quarter of the continent’s medicines are substandard or falsified, while only 2% are produced in Africa, according to AUDA. Through the harmonized regulatory framework, norms and standards, AMA will enable better access and equity to safe, quality medicine, medical products to African patients. This will also bring access to new and innovative technology for vaccines, medicine, medical devices, etc that will serve patients. The huge challenge of expanding universal health coverage – including health insurance – can also be advanced more systematically, with the support of new AMA structures – which should ease affordable access to medications, experts say. Proposed nearly a decade ago A continental medicine agency was first proposed a decade ago, and African Union member states adopted the AMA treaty almost three years ago. But the treaty could only be enforced once 15 AU member states had formally notified the AU Commission that they had ratified the treaty. This happened 30 days ago, when Cameroon became the 15th country to do so, thus setting in motion the formal establishment of the agency. The main aims of the AMA, as listed by the AU Development Agency (AUDA), are to: Support the growth of local pharmaceutical production Evaluate medical products to treat priority diseases identified by the AU Regularly inspect, coordinate and share information about products that are authorised for marketing. Coordinate reviews of clinical trial applications for vaccines and assess product dossiers such as bio-similars. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites. Collaborate with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs) to identify substandard and fake medical products Develop common standards and regulations, which will ensure that the continent’s legislation is harmonised. Responding to the medical crisis caused by COVID-19, the International Alliance of Patients’ Organizations (IAPO) helped to set up a lobby group, the African Medicines Agency Treaty Alliance (AMATA), to push for the speedier establishment of the agency. AMA ‘critically important’ says United States Meanwhile, Jessie Lapenn, the US Ambassador to the African Union, described the AMA as critical important to improving health security in Africa. “The AMA will be another critically important African institution that is part of the broader architecture that will be crucial for strengthening the continent’s health security,” Lapenn said at Thursday’s Africa Centres for Disease Control media briefing. “The US government and US private sector are very much looking forward to collaboration with AMA,” Lapenn added. Along with Cameroon, other countries to have both ratified the AMA and “deposited the instrument of ratification” at the AU (a letter from the head of state informing it of ratification) are predominantly west and north African, and/ Francophone nations, including: Algeria, Benin, Burkina Faso, Gabon, Guinea, Mali, Mauritius, Niger, Seychelles, and Sierra Leone. That may be due, in part, to the fact that the AU’s Special Envoy on the AMA is Michel Sidibé, Mali’s ex-Minister of Health. Now it will be up to southern, eastern and northern Africa to catch up – although Rwanda, Namibia and Zimbabwe have also been among the first to have ratified and deposited the treaty instrument. They were followed by Uganda, which signed the treaty on November 3. https://twitter.com/sabrinah_nati/status/1456617479430709249 Pharma groups welcome AMA’s creation Pharmaceutical companies have long complained about how complicated it is to get medicines approved in Africa and how long it takes – particularly in comparison to Europe, which processes applications via a central European Medicines Agency (EMA). A significant number of African countries’ national medicine regulatory authorities are under-resourced and lacking in expertise. Greg Perry, Assistant Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), welcomed the landmark moment where the treaty has now come into force, describing it as “one step closer to achieving a continent-wide regulatory agency”. “We look forward to the full implementation of the AMA, which will be a game-changer for all Africans to access safe, effective and quality medical products in a timely manner,” said Perry. -Updated on 8 November, 2021 Image Credits: James Oatway/IMF – Healthcare Focus , ©EC/ECHO/Anouk Delafortrie, LinkedIn. Pfizer Says New Anti-Viral Drug Combination Cuts Risks Of Serious COVID-19 By 89% 05/11/2021 Aishwarya Tendolkar Pfizer’s experimental pill works by inhibiting replication of SARS-CoV2 virus. Pfizer Friday announced that its experimental COVID-19 oral antiviral drug PAXLOVID™ reduced risks of hospitalization and death by 89% among patients who received the drug within the first three days of their illness. The company said it had stopped its Phase 2/3 trial on the drug owing to the success rate seen in an interim analysis of 1,219 adults enrolled in the study – who also had chronic health conditions placing them at higher risk of severe COVID. Pfizer is the second pharma firm, after Merck Sharp & Dohme (Merck), to announce highly promising results for an oral drug treatment that reduces serious COVID-19 illness – although the Pfizer results were even more stunning. PAXLOVID™ has the potential to eliminate up to nine out of ten hospitalizations, Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said in a press release. It’s a gamechanger,” Pfizer CEO Albert Bourla told @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” If approved for emergency use by the United States Food and Drug Administration (US FDA), PAXLOVID™ would become the first oral COVID antiviral of its kind. The novel treatment includes a newly- designed SARS-CoV-2-3CL protease inhibitor used in combination with a common anti-HIV drug, ritonavir. Bourla told CNBC that the filing for the drug is expected to be submitted before the U.S. Thanksgiving holiday on Nov. 25. “It’s a gamechanger,” Pfizer CEO Albert Bourla tells @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” https://t.co/IUYCAbZUu9 pic.twitter.com/QTFfJBizPs — CNBC (@CNBC) November 5, 2021 Pfizer’s results more impressive than Merck’s The Pfizer announcement follows Merck’s announcement last month that it’s new oral pill, molnupiravir, had reduced the risks of hospitalization and death by some 50% among people with mild or moderate COVID. The Merck pill, which was approved by UK regulators last week, introduces errors into the genetic code of the SARS-CoV2 virus that it targets, slowing virus replication. Pfizer’s reported results were even more impressive, however. Based on a primary analysis of interim data from 1,219 at-risk adults who were enrolled by September 29, 2021, only three people administered the drug within three days of sympton onset were hospitalized through day 28 of their illness, with no deaths. In the control group, 27 people were hospitalized, with seven subsequent deaths. When the company decided to stop recruiting more patients, their enrollment had reached 70 percent of the planned 3,000 patients across North and South America, Europe, Africa, and Asia. Pfizer drug is based upon a novel protease inhibitor, PF-07321332, that blocks the activity of the enzyme that the coronavirus needs to replicate. Co-administration of ritonavir means that protease inhibitor remains active in the body for longer periods of time to combat the virus. Treatment involves the administration of three PAXLOVID™ pills, twice a day, for five days. Pfizer says it will also ensure equitable access to new drug formulation While Merck’s molnupiravir pill is set to be licensed for generic production in most low- and middle-income countries, Pfizer said that it will offer PAXLOVID™ worldwide, through a tiered pricing approach – while maintaining control of its IP. Last week, Merck and the Medicines Patent Pool signed an agreement that paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell their treatment molnupiravir at discounted prices to more than 105 countries worldwide, once the drug receives approval by the World Health Organization. Pfizer, in contrast, said that its tiered pricing would be “based on the income level of each country to promote equity of access across the globe. “High and upper-middle income countries will pay more than lower income countries,” Pfizer said, adding that it had already entered into advance purchase agreements with “multiple countries and is in negotiations with several others” – without naming which. “Pfizer has also begun and will continue to invest up to approximately $1 billion to support the manufacturing and distribution of this investigational treatment, including exploring potential contract manufacturing options to help ensure access across low- and middle-income countries, pending regulatory authorization.” Image Credits: Wikimedia Commons, peterschreiber.media/Shutterstock . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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Pfizer Says New Anti-Viral Drug Combination Cuts Risks Of Serious COVID-19 By 89% 05/11/2021 Aishwarya Tendolkar Pfizer’s experimental pill works by inhibiting replication of SARS-CoV2 virus. Pfizer Friday announced that its experimental COVID-19 oral antiviral drug PAXLOVID™ reduced risks of hospitalization and death by 89% among patients who received the drug within the first three days of their illness. The company said it had stopped its Phase 2/3 trial on the drug owing to the success rate seen in an interim analysis of 1,219 adults enrolled in the study – who also had chronic health conditions placing them at higher risk of severe COVID. Pfizer is the second pharma firm, after Merck Sharp & Dohme (Merck), to announce highly promising results for an oral drug treatment that reduces serious COVID-19 illness – although the Pfizer results were even more stunning. PAXLOVID™ has the potential to eliminate up to nine out of ten hospitalizations, Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said in a press release. It’s a gamechanger,” Pfizer CEO Albert Bourla told @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” If approved for emergency use by the United States Food and Drug Administration (US FDA), PAXLOVID™ would become the first oral COVID antiviral of its kind. The novel treatment includes a newly- designed SARS-CoV-2-3CL protease inhibitor used in combination with a common anti-HIV drug, ritonavir. Bourla told CNBC that the filing for the drug is expected to be submitted before the U.S. Thanksgiving holiday on Nov. 25. “It’s a gamechanger,” Pfizer CEO Albert Bourla tells @megtirrell about its Covid-19 antiviral drug. “This is a fantastic demonstration of the power of science.” https://t.co/IUYCAbZUu9 pic.twitter.com/QTFfJBizPs — CNBC (@CNBC) November 5, 2021 Pfizer’s results more impressive than Merck’s The Pfizer announcement follows Merck’s announcement last month that it’s new oral pill, molnupiravir, had reduced the risks of hospitalization and death by some 50% among people with mild or moderate COVID. The Merck pill, which was approved by UK regulators last week, introduces errors into the genetic code of the SARS-CoV2 virus that it targets, slowing virus replication. Pfizer’s reported results were even more impressive, however. Based on a primary analysis of interim data from 1,219 at-risk adults who were enrolled by September 29, 2021, only three people administered the drug within three days of sympton onset were hospitalized through day 28 of their illness, with no deaths. In the control group, 27 people were hospitalized, with seven subsequent deaths. When the company decided to stop recruiting more patients, their enrollment had reached 70 percent of the planned 3,000 patients across North and South America, Europe, Africa, and Asia. Pfizer drug is based upon a novel protease inhibitor, PF-07321332, that blocks the activity of the enzyme that the coronavirus needs to replicate. Co-administration of ritonavir means that protease inhibitor remains active in the body for longer periods of time to combat the virus. Treatment involves the administration of three PAXLOVID™ pills, twice a day, for five days. Pfizer says it will also ensure equitable access to new drug formulation While Merck’s molnupiravir pill is set to be licensed for generic production in most low- and middle-income countries, Pfizer said that it will offer PAXLOVID™ worldwide, through a tiered pricing approach – while maintaining control of its IP. Last week, Merck and the Medicines Patent Pool signed an agreement that paves the way for MPP to sign contracts with generic drug manufacturers to produce and sell their treatment molnupiravir at discounted prices to more than 105 countries worldwide, once the drug receives approval by the World Health Organization. Pfizer, in contrast, said that its tiered pricing would be “based on the income level of each country to promote equity of access across the globe. “High and upper-middle income countries will pay more than lower income countries,” Pfizer said, adding that it had already entered into advance purchase agreements with “multiple countries and is in negotiations with several others” – without naming which. “Pfizer has also begun and will continue to invest up to approximately $1 billion to support the manufacturing and distribution of this investigational treatment, including exploring potential contract manufacturing options to help ensure access across low- and middle-income countries, pending regulatory authorization.” Image Credits: Wikimedia Commons, peterschreiber.media/Shutterstock . Posts navigation Older postsNewer posts