Shanghai Cases Surge as China Ramps Up “Zero-Tolerance” Policy to COVID-19 15/04/2022 Raisa Santos Shanghai on 13 April registered 2,573 local COVID19 cases and 25,146 asymptomatic infections.6,740 COVID19 patients were discharged from a makeshift hospital on 13 April. China’s financial hub Shanghai continues to see rising COVID-19 cases despite the country’s attempts at a “no COVID” policy. The city reported over 27,000 coronavirus cases on Thursday, a new high, following Chinese President Xi Jinping’s announcement a day earlier reinforcing the zero-tolerance approach to COVID. “Prevention and control work cannot be relaxed,” Xi said during a trip to the island province of Hainan, the official Xinhua News Agency reported late Wednesday. The policy has involved mass testing, long quarantines, and mostly closed borders. As of Monday, about 343 million people across 45 Chinese cities – accounting for 26% of China’s population and 40% of its economic output – were either under full or partial lockdowns, according to estimates by economists at the investment bank Nomura. But the wide curbs to stop the spread of the highly infectious Omicron variant have led to logistical and supply chain disruptions that are taking economic toll on the country and its people, especially in Shanghai. Makeshift quarantine centers test Shanghai’s patience Shanghai’s current largest fangcang, or makeshift hospital, has set aside 900 beds to treat families with children under the age of 18 infected with COVID-19. While China drums up support for its aggressive COVID strategies, Shanghai residents see their patience being tested amidst family separations and quarantine camps. A video provided on Thursday to Reuters from inside one quarantine center showed people in camp beds separated by less than an arm’s length. An occupant has said that more than 200 people there shared four toilets, with no showers. After testing positive for COVID, people at a quarantine facility in Shanghai lie in rows of grey camp beds, separated by less than an arm’s length, with suitcases and other belongings strewn next to them https://t.co/GlIxVIxQ1N pic.twitter.com/sciLgHVrG4 — Reuters (@Reuters) April 14, 2022 Shanghai has converted multiple public venues to shelter hospitals – or fangcang – to house COVID-19 patients with mild or no symptoms. Children have also been attending online classes in these makeshift quarantine centers, as shown in a tweet from China state-affiliated media Sixth Tone. Children attend online classes at a makeshift quarantine center on Shilong Road on Monday. Shanghai reported 26,330 COVID infections on Wednesday, of which 1,189 were symptomatic. Over 20,000 previously infected people have been discharged from hospitals since March 1. pic.twitter.com/yXXnh6LJrs — Sixth Tone (@SixthTone) April 13, 2022 Once discharged, many former residents of these “shelter hospitals” have complained of difficulties ranging from post-recovery quarantine to securing food supplies to last the lockdown. A Shanghai resident, last name Guo, told Sixth Tone that she waited for about four days to be transferred from a centralized quarantine facility to her home on Wednesday. “Medical staff told us we had met the criteria for being discharged, but had to wait for further notice, again and again … I grew anxious about testing positive again after hearing of a similar case,” Guo said. “Getting infected is actually nothing serious. But the chaos makes me feel exhausted.” More than 20,000 recovered patients were released from six shelter hospitals managed by the city government over the past two days, authorities said Thursday. According to China’s latest rules, those infected are allowed to be discharged from quarantine facilities or hospitals after they test negative for the virus in two consecutive tests, 24 hours apart. International community and local officials express concern for tightened measures Shanghai’s largest makeshift hospital, which can provides 50,000 beds, has been put into use to receive COVID-19 patients. The hospital was converted from the National Exhibition and Convention Center. Shanghai’s lockdown has evoked a sharp response from the international community, as China stands in marked contrast with other parts of the world that are learning to live with the virus. Authorities had imposed a two-stage lockdown to encompass the entire city. “China is going to be left behind,” said Siva Yam, president of the Chicago-based U.S.-China Chamber of Commerce, to US-based media company Politico. “When you look at the United States and Europe, they are opening up, they have accepted the fact that the only way you can control [COVID] is to accept that it will [circulate] in the community.” However, the Chinese government has continued to ramp up its “no COVID” messaging, with China’s official Xinhua news agency warning Thursday that the country’s medical system risked “breaking down” in the event of an even larger COVID outbreak. The state newspaper China Daily boasted last Saturday: “China to defeat Omicron again with dynamic zero-COVID policy” . Officials and experts have expressed concern regarding tightening controls on the healthcare system, with one official close to China’s Center for Disease Control and Prevention telling British newspaper Financial Times that the “zero-COVID policy” is no longer viable. “From a medical standpoint, I don’t think the zero-COVID policy is viable any more. Shanghai is running out of medical professionals to measure test results and beds to accommodate patients.” Image Credits: yelingxuan369/Twitter, Zhang Meifang/Twitter, Yin Sura/Twitter. With COVID Vaccine Supply Outstripping Vaccination Rates, Pharma Giants Question Pursuit of IP Waiver 13/04/2022 Kerry Cullinan IFPMA Director General Thomas Cueni (foreground) with moderator Claire Doole and Albert Bourla, David Ricks and Bill Anderson on screen. Pharmaceutical giants have questioned why a waiver on intellectual property (IP) rights for COVID-19 vaccines is still on the table when they are battling to find markets for their vaccines amid order cancellations – including from the Africa Centre for Disease Control. “I’m stunned that the proposed IP waiver is still being debated while supplies of vaccines are far outstripping demand and some factories have been put to a halt because of missing orders,” Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) told a media briefing on Wednesday. With almost a billion vaccines now being produced every month, countries’ lack of capacity to vaccinate is now the main barrier to stopping COVID-19, added Cueni. In the first quarter of the year 13.7 billion vaccine doses were delivered and 11 billion doses administered, said Cueni. “Now orders are slowing down. Countries as well as organisations such as Africa CDC, are not only asking for orders to be delayed but are cancelling them,” added Cueni. “Leading voices are still calling out vaccine scarcity. I do understand the concern. Vaccines are not reaching all those who need them. But the cause is no longer the lack of supplies. It’s scarcity of vaccination, which is due to the lack of country readiness, absorption capacity and the lack of resources needed to get the vaccines into arms.” Countries’ lack of capacity Pfizer CEO Dr Albert Bourla also weighed in on country capacity, saying that the US government was offering 200 million free doses to the poorest countries of the world but they lacked the capacity to administer the vaccines. “The problem is not if there is availability or access to pricing. The problem is that the infrastructure of these countries is very poor, so they cannot absorb them. They cannot run a vaccination campaign,” said Bourla. Bourla added that one of the pandemic’s key lessons was that more attention should have been paid to preparing countries to vaccinate people. He also described any move to remove IP on vaccines as “insane”, while Roche CEO Bill Anderson described it as “unproductive”. Eli Lilly CEO David Ricks warned that pharmaceutical companies and investors would “never have invested” in trying to develop COVID-19 vaccines “if there was not the promise of IP”. “The next investments on the unknown technology which we can repurpose for the next pandemic won’t be made if investors believe that IP will be undermined,” warned Ricks. “What is a patent? It’s a promise to disclose our inventions in return for a period of exclusivity,” added Ricks. “You’ll get much less disclosure about inventions actually as a result of an IP waiver. There’ll be a strong incentive to retain know-how, retain the recipes for what we do, much like you see in some other industries.” Collaboration successes Bourla said one of the best aspects of the pandemic had been the collaborations between different the industry partners, where competitors worked together, as we as public-private collaboration, particularly with regulators. He commended particularly the US Food and Drug Administration, the European Medicines Agency and the Canadian, Israeli and Japanese regulators for their speedy reviews of industry data. “What did not help was the politicisation – if you take a vaccine or not, or wear a mask or not. Tthat created tremendous damage to the global health,” said Bourla. At the IFPMA briefing (clockwise): Pfizer CEO Albert Bourla, IFPMA Director General Thomas Cueni and moderator Claire Doole, Roche CEO Bill Anderson and Eli Lilly CEO David Ricks Future COVID vaccines The IFPMA noted that there was “increasing acceptance that society will have to live with COVID-19”, and that continued innovation remains essential to expand on the 10 vaccines that have so far received WHO Emergency Use Listing approval and the 18 different treatments that have been approved in the UK, USA, and EU. Bourla said that Pfizer and Moderna were working on “multivariant” vaccines but this was “very challenging”, as was developing a COVID-19 vaccine that offered robust protection for at least a year. He hoped this would be ready for testing in the third quarter of the year. COVID-19 Pandemic Still Poses a Danger Despite Lower Case Rates, Says WHO 13/04/2022 Aishwarya Tendolkar A COVID-19 vaccination being administered in Senegal. COVID-19 affiliated deaths last week were the lowest on record globally since the pandemic began two years ago. But the World Health Organisation (WHO) today emphasized that the pandemic remains a public health emergency and we must not drop our guards. “This is the moment to work even harder to save lives,” said Dr Tedros Adhanom Ghebreyesus, the Director-General of WHO, at a press briefing on Wednesday in Geneva. “This virus has over time become more transmissible and it remains deadly, especially for the unprotected and unvaccinated that don’t have access to health care and antivirals. The best way to protect yourself is to get vaccinated and boosted when recommended,” he said. The briefing comes at the end of a meeting of the WHO Emergency Committee convened under the International Health Regulations (IHR). The committee discussed the capacities of states to respond to the pandemic, the problem of vaccine inequity, reduced testing and monitoring, and raised concerns about the inappropriate use of antivirals that may give impetus to drug-resistant variants. Ukraine and Ethiopia In the past 50 days since theRussia invasion of Ukraine, 4.6 million refugees have fled the country, and thousands of civilians, including children, have died, and there have been 119 verified attacks on health care workers. Dr Tedros said that there is a need for humanitarian corridors to enable the delivery of medical supplies, food and water and the evacuation of civilians. He added that to date, the WHO had only received about half of the funding needed to support Ukraine for the first three months. Dr Michael Ryan, WHO’s Executive Director of Health Emergencies, said that there was a high risk of chemical contamination and exposure due to attacks, as well as compromised infrastructure associated with the chemical production, nuclear weapons and energy production. Dr Michael Ryan at the WHO Press Briefing. “We’ve been doing training and other support to the authorities in Ukraine in preparation for such an event. This is very different from the intentional use of chemicals as a weapon in war, which is against international Law and is a war crime,” said Ryan. This comes on the back of reports of the use of chemical weapons in Mariupol. With respect to Ethiopia, Tedors said that the siege by the Ethiopian and Eritrean forces continues to avert the humanitarian calamity and thousands of people from dying. Tedros, who is an Ethiopian and a former Minister of Foreign Affairs, said that the Tigray crisis is one of the most alarming humanitarian crises of our times. “But the world is not treating the human race the same way. Some are more equal than others,” he said referring to the negligible attention received by Afghanistan, Ethiopia, Yemen, and Libya versus the attention that is meted to Ukraine currently. Newer variants According to Dr Maria Van Kerkhove, WHO’s Technical lead on COVID-19, the new sub-variants of the Omicron variant– BA.4 and BA.5– have been reported from a number of countries, including South Africa, in Europe. She said that more sequencing and concerted global efforts to track and share the data on the virus are needed to understand the characteristics of the variants. Responding to the concerns about the reduced testing and tracking of COVID-19 cases, Ryan said that it was important to track the virus as it went “underground”. “It will be very, very, very short-sighted at this time to assume that lower numbers of cases mean an absolute lower risk,” he said. “This virus has surprised us before… We need to do our jobs and track this virus as best we can while people get back to living as normal a life as possible. We in the scientific and public health community need to continue to track this virus closely in every single country.” Dr Maria Van Kerkhove,WHO’s Technical lead for COVID-19, Van Kerkhove added that the committee which met today outlined three main scenarios in the modified Strategic Preparedness, Readiness, and Response Plan (SPRRP) publication: a best case, a worst case, and a base case in terms of outlining what virus evolution and changes and how our countermeasures will react or react to those. There is also a fourth scenario, called ‘reset’ where there is so much change in the virus there will be a population that is susceptible again, and “it resets us.” Vaccinate, vaccinate, vaccinate The updated SPRRP report highlights the need to achieve national COVID-19 vaccination targets in line with global WHO recommendations of at least 70% of all countries’ populations vaccinated by the start of July 2022. “Countries really must start looking at their data breakdown by age and sex,” said Dr Soumya Swaminathan, WHO’s Chief Scientist, while highlighting the importance of boosting the population over the age of 60. Swaminathan added that a majority of countries plan to meet the 70% target, but a handful of countries have set their goal at less than 40%. “ Many of these countries have competing health priorities and so we need to make sure that as COVID vaccine uptake is expanded, scaled up, strengthened, and routine immunization services are also strengthened,” said Swaminathan. Swaminathan mentioned that COVAX has the capability to cater to the vaccination needs of the vulnerable population, but there needs to be more focus on making sure the older, more vulnerable population is catered to and not left out despite the inequitable vaccine situation currently. “The inequity is not just in the overall distribution of vaccines, it is also occurring within countries in terms of not reaching those most likely to benefit from the vaccine and that’s particularly acute,” said Ryan. He added that while 85% of the population over 60 years of age in Europe is fully vaccinated, the number for the same metric stands at 25% in Africa. “If we fail to vaccinate everyone, if we fail to continue diagnosing, if we fail to find the people who can benefit from treatment, then we will fail in the future, and in the next pandemic. So our success now will determine a successful future,” Ryan said. Image Credits: Flickr – Trinity Care Foundation, Georges Yameogo.. Global Health Matters: Around the World of Public Health in Audio 13/04/2022 Maayan Hoffman Global Health Matters podcast host Dr. Garry Aslanyan, TDR After Dr Garry Aslanyan became an avid follower of podcasts, he realized there was a dearth of material from the genre in his own global health field. So he set out to fill that gap with a new series featuring public health professionals and policymakers from around the world who have made a difference – and can inspire others as well. The Global Health Matters podcast hosted by Aslanyan, a public health professional with TDR, the Special Programme for Research and Training in Tropical Diseases, co-sponsored by UNICEF, UNDP, the World Bank and WHO, is now entering its second season of broadcasts. It features a diverse mix of themes and line-up of speakers – has picked up an audience of followers in places as diverse as Yemeni villages and Ulaanbaatar, Mongolia. The first episode of Season 2 was launched on Tuesday, April 12. It focuses on “Championing Health Equity in South Africa.” “The podcast gives people a unique peek into the experiences of people who are just like them,” Aslanyan told Health Policy Watch. “Listeners can relate to the guests and their experiences and compare what they themselves are living through – they can think, ‘can I do this?’ or ‘how does that work?’ or ‘what can this mean for me in my own setting or country?’” The podcast began at the height of the COVID-19 pandemic, when new, virtual information tools became all the more important to people confined for days and weeks at home. The podcast series has already covered a broad range of innovative and inspiring research topics – from climate change and health to science communication and the challenge of ‘decolonizing global health.’ With a focus on sharing perspectives and voices from low- and middle-income countries, the series has already been downloaded more than 11,000 times by listeners in more than 130 countries, Aslanyan said. “The hope is to inspire listeners to do something in their day job with the information they heard,” Aslanyan said. South Africa at the nexus of the global health equity debate This week’s episode on “Championing health equity in South Africa” takes a long look at the country’s COVID vaccine campaign, whose successes and setbacks were a weathervane for the rest of Africa, as well as its precedent-setting examples in advocating for HIV medicines access, in light of the recent pandemic. “As of early March, 74% of those in high-income countries have been fully vaccinated against COVID-19, compared with just 11% of people in low-income countries. As the world commits to global access to medicines and vaccines, is this just on paper or a reality?” the podcast teaser states. “Can South Africa’s experience with tackling HIV/AIDS and COVID-19 point to future solutions for other low- and middle-income countries? How has intellectual property rights affected development of vaccines across Africa?” Appearing on the podcast are three guests: human rights lawyer and activist Fatima Hassan; UNDP policy specialist Judit Rius Sanjuan; and Petro Terblanche, Managing Director of Afrigen Biologics, host of the new mRNA hub in South Africa. Season 2 of Global Health Matters launched this week: Championing Health Equity in South Africa. The goal: To inspire Aslanyan said he started the series after becoming an active listener of podcasts himself. He fell for the audio genre because it runs against the current of 30-second social media soundbytes, providing more thoughtful and detailed coverage of issues in a digestible format – that listeners can tune into while they are travelling or doing something else. But when he searched for something that “really covers global health, I did not find much” – especially not one that featured voices from low- and middle- income countries. So, he and his team decided to start their own series. “The ability to get a more insightful, in-depth understanding of a topic is why this medium is appealing. And for us at TDR, most importantly, this allows people from around the globe to learn from the experiences of others and apply them to their own reality,” said Aslanyan. Although WHO’s Regional Office for Europe offers a ‘Health in Europe’ podcast, and WHO headquarters features a popular Science in Five video series, Global Health Matters is the only broad-based and regular global health podcast featured by WHO, where TDR is based. Aslanyan has postgraduate training in public health and health policy and systems. While not a trained media professional, he was driven by a clear public health mission: to inspire his colleagues in the field. “You may not immediately think somebody trained in public health to host a podcast, but I have done all kinds of work for organizations focused on global health,” Aslanyan explained. “I also have experience in innovation and advocacy and have worked in government departments in Canada before moving to Geneva where I really pushed the boundaries of national health.” He said public health professionals need to be knowledgeable but also able to present things in a way that galvanizes the public around different causes. He had not thought of himself as that person before starting Global Health Matters, but since launch last year he hears from listeners that this is exactly the role he and his guests are fulfilling. “What makes me think that the podcast medium is amazing is the way that we reach cities, towns and villages in the most remote parts of the world, which is VERY satisfying – we know that from our stats,” Aslanyan says. What were some of the most popular episodes last year? “COVID-19 in Africa: the role of research” helped debunk some of the myths around why there was less virus on the continent. Global Health Matters Episode 3. An episode on “Climate change’s impact on health” looked at the impact of climate change on rural areas whose communities’ health and livelihood depends on the environment. A particular focus was on Maasai communities in northern Tanzania, where persistent droughts have made the people vulnerable to sleeping sickness, a disease spread by the tsetse fly. There was also a piece on Communicating science, not fiction featured Natalia Pasternak, founder of Brazilian-based Instituto Questão de Ciência, which combats pseudoscience and advocates for evidence-based treatments. Natalia spoke of her own personal experience as a member of WhatsApp groups for mothers that took a sudden turn into vaccine skepticism. And thousands of kilometers away, in the Western Pacific, Navigating digital health waves featuring Dr Alvin Marcelo, Executive Director of the Asia eHealth Information Network, explained how the Philippine government allowed open access to data from COVID-19 tests, creating a big opportunity for health researchers and services, for instance better matching of COVID-19 test results from particular locations with availability of hospital bed spaces. Natalia Pasternak, founder of Brazilian-based Instituto Questão de Ciência Dr Alvin Marcelo, Executive Director of the Asia eHealth Information Network. “Of course, we get feedback on every episode,” Aslanyan said. “It seems all of them have touched, inspired or at least piqued the interest of our listeners.” He said that he and his team at TDR stepped into podcasting with no experience but they have already learned a lot. Season 2 builds on last year’s, bringing in additional topics such as science diplomacy, corruption in health, migration and health and diversity in global health. Aslanyan said he also hopes to add an even greater variety of personalities to the podcasts, including, potentially, some guests who are public health service recipients rather than providers. He added that two universities in the global North and South are using some podcast episodes to assist students in understanding complex public health subjects – a testimony to the information and clarity being provided by the show. “We think it gives learners the ability to relate to the topics they are studying,” Aslanyan said. In terms of the spread and reach of his audience- it’s both surprising and satisfying, Aslanyan adds. “Sometimes I look at the analytics data showing the people listening to the podcast, and I think, my gosh, who are these eight people in that small city in Yemen who listened to me? I have no idea who they are, but they are there, in a place I don’t know, and I imagine they are probably working in public health.” The first episode of Season 2 launched on Tuesday April 12. Find it here. Link here to all Season 1 episodes of Global Health Matters. Find it on YouTube Championing Health Equity in South Africa Follow @TDRnews on Twitter, TDR on LinkedIn and @ghm_podcast on Instagram for updates about upcoming shows. Image Credits: WHO, GHM Show , GHM. Championing Health Equity in South Africa – Global Health Matters Podcast Series 13/04/2022 Editorial team The second season of the Global Health Matters podcast series kicks off with a close-up look at South Africa’s health equity initiatives and champions. Health Policy Watch will be featuring episodes from the series throughout the coming year as part of a TDR-supported series. As the world commits to equitable access to medicines and vaccines, is this just on paper or a reality? In the case of COVID-19, as of early April 2022, 74% of people in high-income countries had been fully vaccinated, compared with just 15% in Africa and 11% of people in low-income countries worldwide. With 30% of people fully vaccinated, South Africa, has one of the highest COVID vaccination rates in sub-Saharan Africa. And it has been an African leader in the manufacture of COVID vaccines, as well as a leader in the global campaign to waive intellectual property rights on COVID vaccines, tests and treatment – not to mention the historic role it played a generation ago in the legal battles that paved the way for the widespread manufacture of low-cost, generic antivirals for HIV treatment. Can South Africa’s experience with tackling HIV/AIDS and COVID-19 point to future solutions for other low- and middle-income countries? And how has the state of play regarding intellectual property rights for COVID health products affected development of vaccines across Africa? Global Health Matters podcast host Garry Aslanyan fields these and other questions to three leading South Africans scientists, policymakers and health activists, including Fatima Hassan (founder of the Health Justice Initiative), Petro Terblanche (Managing Director of Afrigen Biologics), and Judit Rius Sanjuan (Policy Specialist at UNDP). Click here to catch this episode, the first of the second season of TDR’s Global Health Matters podcast. Find it on YouTube: Championing Health Equity in South Africa Link here for all Season 1 episodes of Global Health Matters. Historic Public Hearings on WHO Pandemic Instrument; Some Unhappiness with Process 12/04/2022 Kerry Cullinan The last Ebola patient leaves a treatment centre in the Democratic Republic of Congo at the end of March 2021, marking the countdown to declaring the end of that pandemic. The World Health Organization (WHO) convened public hearings for only the second time in its history on Tuesday, asking interested parties what substantive issues should be contained in its proposed international instrument on pandemic preparedness and response. The first and only other WHO hearings were held 22 years ago in the run-up to the adoption of the Framework Convention on Tobacco Control, according to WHO principal legal officer Steven Solomon. Welcoming the public hearing, WHO Director-General Dr Tedros Adhanom Ghebreyesus said that informed opinion and active public cooperation are of the utmost importance to improve health, and it was important to learn from the COVID-19 pandemic to ensure the world is “better prepared” for the next pandemic. Tedros had been mandated by last year’s World Health Assembly Special Session to convene public hearings to inform the work of the Intergovernmental Negotiating Body (INB) which is in charge of negotiating the pandemic instrument or treaty. INB co-chair, South Africa’s Dr Precious Matsoso, described the hearings as “remarkable” and “historic”. Dr Precious Matsoso, INB co-chair Narrow responsibility However, the Civil Society Alliance for Human Rights in the Pandemic Treaty warned that the consultative process risks being “inadequate”. “While this week’s public hearings reflect the INB’s stated objective to consult the public to some extent, it has interpreted its responsibility to do so very narrowly,” according to the alliance. “The INB has allocated minimal time to engaging with the wide range of stakeholders who could inform the process and improve both the legitimacy and quality of the Treaty that emerges.” Dr Meg Davis, from the Global Health Centre at the Graduate Institute in Geneva, also said that participants had been given no indication of whether or how their submissions would be included in the negotiations and recommended policymaking models to ensure meaningful civil society engagement. A number of organisations gave two-minute speeches focusing on a wide range of issues including ‘One Health’, research and development (R&D) and intellectual property rights at the hearings, which continue on Wednesday and then reconvene in mid-June. Equity means sharing Research and Development Professor Suerie Moon, co-director of the Global Health Centre at the Graduate Institute in Geneva. All member states have committed to equity at the heart of any pandemic instrument, but Professor Suerie Moon, co-director of the Geneva Graduate Institute’s Global Health Centre, told the hearings that “equity requires collective research and development of vaccines, drugs and diagnostics”. Pointing out that COVID-19 has led to the development of technology transfer hubs in South Africa and the Republic of Korea, Moon warned that “there’s a risk that new factories will sit idle in the next emergency unless the new international instrument forges agreement on obligations to share knowledge, data and intellectual property before and during future emergencies”. “It’s unlikely, however, that countries or companies will do so out of the goodness of their hearts,” added Moon. “To make such sharing feasible, we have to tie it to commitments to jointly finance research and development to share pathogen samples and genomic sequencing data. In other words, the key idea is collective research and development for collective benefit.” Acknowledging that intellectual property was a difficult issue, Moon nonetheless said that if equitable access was to become a reality “the new instrument must include the nuts-and-bolts provisions to make sharing technology for pandemics the new normal”. To address IP, Knowledge Ecology International (KEI) recommended that governments should “agree to collectively use exceptions to intellectual property rights that are permitted in existing trade agreements and treaties”. “A model for this is the WIPO Marrakesh Treaty for the Blind, which mandates its members to use exceptions in copyrights to enhance global access to works made accessible to persons who are blind or have other disabilities,” according to KEI’s James Love. KEI also proposed “a robust chapter on transparency”, adding that “the lack of transparency in many areas for the current pandemic is an appalling and unnecessary policy failure, and one that both makes it more difficult to manage a pandemic response, and undermines the public’s trust in institutions”. Rachael Crockett from the Drugs for Neglected Diseases initiative (DNDi) stressed the need to co-ordinate R&D as a substantive element of the new instrument. DNDi wants R&D priority setting, and “globally agreed norms and binding rules that govern the R&D process, including transparency and open sharing of research, data, knowledge, technology, and equitable allocation of health tools”. Sharing pathogens IFPMA’s Grega Kumer Grega Kumer from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) said “any system should be built on what worked well during the COVID pandemic, in particular, immediate sharing of pathogens and a robust response from the IP based private sector”. The IFPMA presented eight core principles, including that the negotiation process should be “inclusive and transparent, involving the private sector and all critical contributors to pandemic preparedness efforts”. “Any system should allow for immediate access of pathogens and genetic sequence data and correct the negative effects of access and benefit-sharing legislation,” said Kumer. The IFPMA also supports more equitable access to tests, treatments and vaccines “based on medical need, thus enhancing solidarity and facilitating emergency financing to institutions procuring for developing countries”, and the protection of supply chains ”from arbitrary export restrictions and other trade barriers”. “While the public sector might play a larger role in pandemic setting, the system should build on the private sector strengths for R&D, manufacturing and distribution,” he concluded. One Health is key The need for any pandemic instrument to adopt a One Health approach also emerged as a key theme. Dame Sally Davies, speaking for the UN Global Leaders Group on Antimicrobial Resistance (AMR), said that they wanted AMR to be integrated alongside a primary focus on pandemics. “The next pandemic could be drug-resistant, or could depend on antimicrobials to mitigate it,” said Davies, saying that one health surveillance needed to be at the heart of any pandemic treaty to enable “rapid, transparent and responsive protection”. Governance principles The Panel for a Global Health Convention believes the instrument must be governed by four non-negotiable principles, according to Dame Barbara Stocking. “Solidarity, because we’re all in this together, and solidarity is in our own self-interest,” explained Stocking. “Equity: there must be equal access to vaccines and treatments, but also an equal voice in decision-making. Transparency in reporting data and samples. Accountability, as the lack of accountability of countries is the fundamental reason that we are in disarray.” The hearings continue at 8am CET on Wednesday and can be followed live. Image Credits: WHO African Region. Nineteen More Attacks on Ukraine’s Health Facilities Since Friday: WHO 11/04/2022 Kerry Cullinan Ukraine operating theatre destroyed The World Health Organization (WHO) has verified 108 attacks on health care in Ukraine as of Monday in which 73 people have died and 51 have been injured. That is 19 more attacks on health facilities than the already deadly toll of 91 attacks that had been verified by WHO as of early Friday afternoon, and as reported at a press conference by WHO’s Regional Director Hans Kluge in Lviv. .@WHO has verified 5 additional reports of attacks on health care in #Ukraine. As of 11 April, 108 attacks on health care in Ukraine have been verified, causing 73 deaths and 51 injuries. We are outraged that attacks on health care are continuing. pic.twitter.com/8GNUQZFiK9 — WHO Ukraine (@WHOUkraine) April 11, 2022 Meanwhile, the Office of the UN High Commissioner for Human Rights (OHCHR) has recorded 1,793 civilian deaths and 2,439 injuries since the start of the Russian invasion on 24 February and Sunday. Most of the civilian casualties have been caused by “explosive weapons with a wide impact area”, including shelling from heavy artillery and rocket, missile and air strikes. https://data.humdata.org/visualization/ukraine-humanitarian-operations/ “OHCHR believes that the actual figures are considerably higher, as the receipt of information from some locations where intense hostilities have been going on has been delayed and many reports are still pending corroboration,” according to a statement from the office. “This concerns, for example, Mariupol (Donetsk region), Izium (Kharkiv region), Popasna (Luhansk region), and Borodianka (Kyiv region), where there are allegations of numerous civilian casualties. These figures are being further corroborated and are not included in the above statistics.” According to the Prosecutor General’s Office of Ukraine, 176 children had been killed and at least 336 injured as of Sunday. Image Credits: WHO. Pfizer Refuses Cooperation with DNDi on Study of Paxlovid Treatment Adapted to Low Income Countries 08/04/2022 Elaine Ruth Fletcher & Kerry Cullinan Paxlovid Pfizer has so far refused an invitation from the Geneva-based Drugs for Neglected Diseases Initiative (DNDi) to cooperate on a study exploring whether the treatment window of its successful antiviral drug, Paxlovid, could be extended from 5-7 days using another drug compound in addition, Dr Nathalie Strub-Wourgaft, Director of DNDi’s COVID-19 Response, told Health Policy Watch. DNDi wants to test if the key active ingredient of Paxlovid, nirmatrelvir, could be offered in combination with an inhaled corticosteroid, budesonide, in order to extend the treatment window of the life-saving COVID treatment by two more days, Strub-Wourgaft said in an interview. Extending the treatment window is critical for patients in low-income countries because the currently-approved formulation of Paxlovid must be commenced within 3-5 days of COVID symptoms. Meanwhile ANTICOV, a major DNDi-sponsored trial of COVID treatments underway in ten African countries, has revealed that one-half of COVID patients present for treatment after the five day cut-off date. ANTICOV clinical trial. That makes the current Paxlovid combination less than suitable for low- and middle-income country (LMIC) conditions, said Strub-Wourgaft. She is one of the coordinators of the ANTICOV Consortium, a group of 26 African and global research organizations engaged in the clinical trial research on novel COVID drugs for LMICs. On 15 March, DNDi issued a public statement expressing its concern that “efforts to conduct urgently needed studies in low- and middle-income countries (LMICs) utilizing the novel oral antiviral, nirmatrelvir/ritonavir (Paxlovid), are being blocked by Pfizer, which developed the drug. Paxlovid, which uses the common HIV drug ritonavir in combination with nirmatrelvir, has been found to reduce the risk of hospitalization or death by a stunning 89% in patients at high risk of severe COVID-19 disease. But the treatment needs to be taken within three to five days of patients developing symptoms. According to DNDi, “an interim analysis done in the context of the ongoing ANTICOV clinical trial conducted in 10 African countries showed that of the 1180 patients enrolled, more than half present for care after day 5. “To overcome this challenge, it is necessary to explore whether using Paxlovid with other drugs could widen the ‘treatment window’ to at least seven days,” DNDi said in its statement. DNDi also wants to investigate if the drug could be “beneficial for immune-suppressed patients who are the most vulnerable to disease progression but were excluded from phase 3 trials.” DNDi, a Geneva-based not-for-profit research and development organisation, works to deliver new treatments on neglected diseases and serving neglected groups in low- and middle-income countries. Still looking for ways to access nirmatrelvir DNDi drug development. Strub, in her comments to Health Policy Watch, suggested that DNDi, which has a good track record of building cooperation with the pharma industry, was still trying to obtain the drug somehow – or even persuade Pfizer to collaborate. “We would like to test nirmatrelvir/ritonavir in combination, as well, with inhaled budesonide or maybe fluoxetine (brand name Prozac),” said Strub-Wourgaft. “We issued a statement to say that we had asked Pfizer to get access to nirmatrelvir, to work with us on this trial. They denied. We’re continuing to try to get access to this drug.” “We think this [combination] would extend the window of treatment to seven days of symptoms. In the study that they [Pfizer] have done, which is a great study showing really fantastic results, they looked at patients who had five days of symptoms before they were enrolled. “And we have seen for now, in our study in Africa, that half of the patients come after five days of symptoms,” she said. Such delays are typical because COVID diagnosis and treatment services are less widely available and it thus takes people longer to get diagnosed, even if they are symptomatically ill. “There are critically important public health research questions that must be answered quickly – particularly in low- and middle-income countries where access to vaccines remains low,” added Strub-Wourgaft, in the DNDi statement. “It is difficult to understand any rationale for refusing to cooperate in the midst of a global pandemic, and this sets a dangerous precedent since there are many other promising antivirals in the pipeline and these novel treatments will also require follow-on research to determine their optimal use in resource-limited settings.” MPP deal with Pfizer – not enough Pfizer recently signed a deal with another Geneva-based group, the non-profit Medicines Patent Pool, that will allow 35 new manufacturers to produce and supply generic versions of Paxlovid to some 95 low- and middle income countries – in what the company has said is a move to lower the drug’s cost and expand access in low-income countries. But that deal has also been criticised for failing to cover dozens of other middle-income and upper-middle income countries that will have to purchase patented versions of the drug. Although Pfizer had also said that it would create a tiered pricing system for Paxlovid, drug price advocates say that the price remains too high in many settings. In the United States, the government pays Pfizer about $530 for a five day course, although the pills also are in short supply in some US communities. In addition, most of Pfizer’s Paxlovid supply for the first half of 2022 has already been bought up by rich countries, meaning that LMICs will only be able to get about 10 million doses of the drug in the near term. Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates However, even considering the MPP deal and other preferential pricing mechanisms, the fact remains that the version of Paxlovid currently being produced is not an optimal fit for many LMICs, Strub-Wourgaft said. “So for now, if we were to be able to give them Paxlovid, under the current conditions, half of them would not even have access,” she told Health Policy Watch. MPP deals with generic manufacturers may not enable supplies to ANTICOV DNDi is also concerned about the potential difficulty of obtaining generic versions of Paxlovid to conduct the new ANTICOV combination studies, the company has said. “The terms of the Pfizer/Medicines Patent Pool (MPP) licensing agreement to the new generics manufacturers could be interpreted to mean that sub-licensees cannot provide nirmatrelvir/ritonavir for use in the sorts of combination studies that DNDi and others wish to conduct, unless they have explicit written approval from Pfizer. “Some generic manufacturers are also encountering difficulties obtaining Paxlovid as a ‘reference drug’ so that they can conduct the necessary bioequivalence studies to show regulators that their generic version has the same effect in the body, effectively blocking availability of generics for both research and clinical use”, DNDi added in its statement. It has therefore asked Pfizer to not only provide access to nirmatrelvir/ritonavir (Paxlovid) for the DNDi-coordinated ANTICOV trial and other relevant clinical trials, but also to: Remove any ambiguities or restrictions in the Pfizer-MPP licensing agreement that could prevent sub-licensees from supplying such research studies (or publicly clarify that no such restrictions exist); Provide access to Pfizer’s originator product as a ‘reference drug’ so that any interested generic manufacturer can conduct the necessary bioequivalence studies for regulatory approval; and Allocate sufficient quantities of Paxlovid specifically for LMICs and remove all barriers to access to generic nirmatrelvir/ritonavir to enable scale up for care and treatment in LMICs. “Every effort should be made to ensure that clinical studies for COVID-19 treatment are conducted in low- and middle-income countries, and that any products developed reach vulnerable populations,” said Dr John Amuasi, head of the Global Health and Infectious Diseases Research Grou at Kumasi Center for Collaborative Research in Tropical Medicine in Ghana and a principal investigator for ANTICOV. “We must not arrive at a situation where research priorities are determined by the actions or inactions of any company.” Pfizer response – committed to well-controlled trials In response to a request from Health Policy Watch, a Pfizer spokesperson did not provide any clarification of the reasons behind the company’s refusal to participate in the DNDi trial – aimed a making the treatment more suitable to low-income settings. “Pfizer appreciates the importance of gathering additional data and information for governments to help maximize the public health response to the COVID-19 pandemic,” said the spokesperson, adding that the company is committed to “well-controlled, hypothesis-driven clinical studies that can provide data that will be accepted by global regulatory agencies. “Additional studies of PAXLOVID are underway or are being explored, and we will continue to share information as we have it,” the spokesperson added. In addition, “Right now, we are focusing our efforts and resources in a way that maximizes availability of our overall supply, to help ensure access to patients as quickly as possible,” the spokesperson said, noting that the company remains “confident” in the clinical trial results, which showed an 88-89% efficacy rate for the drug, when it was administered to non-hospitalized, high-risk patients within 3-5 days of symptom onset. -Updated 9 April with correction on the price of Paxlovid paid by the US government for patients in the USA and on 11 April with details of Pfizer response. Image Credits: Bobbi-Jean MacKinnon, DNDI/Twitter, DNDi. Artificial Intelligence ‘Boot Camp’ Aims to Accelerate Drug Discovery 08/04/2022 Maayan Hoffman Machine learning is playing an increasingly important role in computing and artificial intelligence. TEL AVIV – Ninety percent of drug candidates fail in clinical trials because of unexpected safety issues or lack of efficacy in human subjects, according to Noga Yerushalmi, Investment Director at M Ventures, the strategic, corporate venture capital arm of Merck. There have been dramatic improvements in omics technologies – that is the collective technologies used to explore molecular behaviour, such as genomics, proteomics, metabolomics, metagenomics and transcriptomics. And this is enabling scientists to analyze potential drug targets more efficiently in terms of their potential impact on a pathogen or disease. But there is no automated solution that harnesses all preclinical data in a way that allows for a reliable assessment of the clinical trial readiness of a new drug candidate. Now, some pharma and research initiatives are hoping to change that, among them AION Labs. Together with its German partner BioMed X, the Israeli-based research alliance, hosted 15 teams of computational biologists, AI researchers and biomedical scientists for a ‘boot camp’ that aims to speed up the drug discovery process and lower costs – harnessing AI technologies in novel ways. Mission: identify critical safety issues before expensive clinical trial stage The latest boot camp cohort The teams were charged with making a proposal for the development of a versatile, next-generation computational platform that can identify hidden safety liability and lack of efficacy, and close identified gaps in the drug candidate pre-clinical data package. “The big problem in drug discovery and development is that after a lot of experiments have been done and we have a new drug candidate, many of these candidates fail in very expensive clinical trials in humans,” Dr. Christian Tidona, founder and managing director of the BioMed X Institute told Health Policy Watch. “That’s because humans are different from mice or a dish in the lab.” The challenge is that pharma companies usually only discover that a drug candidate either is not safe or will not work after years of effort and hundreds of millions of dollars of investment. Companies can invest $5 billion and 12-years’ time, on average, Tidona said, to create the next “blockbuster drug.” “When one thinks about these numbers, he can imagine why some of these drugs are so expensive. Could an AI platform predict if a drug is really ready for the clinic and, if not, tell us what was missed before we go to trial?” Tidona asked. “This is the question. “If drugs can be made more efficiently, medicines can become cheaper and more people in all parts of the world could afford them,” he said. Solving therapeutic challenges Kahina Lang, head of Strategic Innovation at Merck Group, addresses the candidates at the AION Labs boot camp. Based in Rehovot, not far from the the famed Weizmann Institute, AION brings together some of the biggest names in pharma, including AstraZeneca, Merck, Pfizer, and Teva, with young biotech inventors and entrepreneurs, to crack biomedical research challenges together and in a novel way. “We work with each of our pharma partners separately and then together to identify the top research challenges that solving would be majorly impactful for the industry at large,” AION CEO Mati Gill told Health Policy Watch. Then, AION looks for innovators and scientists to develop solutions for them. For last week’s boot camp, 15 applicants from around the world were selected to come to Israel and participate. “The winner receives a $2 million investment, mentorship and access to a wealth of data for model training from these four big pharma companies,” Tidona said. “It is more or less paradise for anyone who wants to start a company.” The concept is based on a model Tidona first developed on the campus of the University of Heidelberg in Germany, with a world-wide network of partner locations. If the company succeeds, the technology belongs to it but will be made available for purchase by the pharma partners. ‘Bringing the promise of AI to fruition’ Guy Spigelman of AWS addresses candidates at the AION Labs bootcamp. Merck’s Yerushalmi said that there have been “all kinds of efforts to make the drug development model more efficient – to expedite it,” but until now it has not worked. When computational approaches to research were first introduced, “it brought a lot of promise, but until now it has not brought as much fruit as we hoped. Now, with AI tools and the amount of data pharma and other companies can generate, we do hope we may be able to bring this promise to fruition.” AI is one of the most sophisticated computational tools. AI analysis has brought “ingenious” solutions to other fields, like the automotive industry, she pointed out. “AI tools and big data have proven themselves in so many other cases, I think it will probably work for our industry too,” Yerushalmi said. “Want to make [drug development] more affordable and shorter, so we can bring drugs to the market faster and cheaper for the benefit of humanity.” Finding the most effective antibodies AION will be looking for the next therapeutic antibodies. This most recent boot camp was AION’s second one so far. Earlier this year, it invited computational biologists and biomedical scientists to propose ideas for discovering therapeutic antibodies. “Advances in protein structure prediction, artificial intelligence algorithms, and increased availability of experimentally determined antigen-antibody structures present a unique opportunity for AI-driven antibody discovery,” AION said in a release. In the coming months, it will hold a third boot camp at which computational biologists, bioinformatics and cheminformatics scientists and AI researchers will propose ideas for the development of a next-generation computational platform to optimize antibodies for targeted therapies with enhanced properties, including developability or manufacturability, stability, aggregation, immunogenicity, pharmacokinetics and tissue distribution. “The ultimate solution is an AI platform that receives sequences of binders and generates novel variants with optimized IgG sequences, biophysical and targeting properties,” a background briefing explained. “The goal of the AI algorithm is to make an existing antibody a better drug while reducing design iterations, optimization of cycle times and lowering attrition rates.” CEPI launches AI-based quest for beta-coronavirus vaccine candidate The AION initiative, while pioneering in the use of AI for drug discovery, is not the only one. On Thursday, the Oslo-based Coalition for Epidemic Preparedness (CEPI) announced that it would provide seed funding of up to US $4.8 million to a consortium to support the AI-based development of betacoronavirus vaccine candidates – the new holy grail for coronavirus vaccines. The research consortium, led by a Norway-based subsidiary of the Japanese NEC Group, which specializes in AI technologies, also includes the European Vaccine Initiative (EVI) and Oslo University Hospital. It aims to establish preclinical proof of concept for an mRNA-based vaccine that protects against a broad range of beta coronaviruses – rather than SARS-CoV2 alone, said CEPI in a press release. NEC will apply its experience in the AI design of immunogens to identify novel vaccine antigens with broad reactivity against beta-coronaviruses. The lead antigens will be selected iteratively and validated in preclinical studies against known beta coronaviruses that already pose a significant epidemic or pandemic risk, such as SARS-CoV, SARS-CoV-2 and MERS-CoV. If the approach is successful, it may also be applicable for developing vaccines against other pathogens in the CEPI portfolio, including ‘Disease X’ – unknown pathogens with pandemic potential that have yet to emerge. What the future holds What the future of AI holds. Tidona, for his part, hopes that AION will spin off 20 new start-ups in the next four to six years. “We are building an innovation ecosystem,” he said, noting that it is attractive to host countries as it provides a draw for youthful talent, which in turn spurs economic development. He added that if the model works well, BioMed X plans to export it to other countries as well. “The focus now is on Israel as our first partner outside Germany,” Tidona said. “But in the future, we hope to have sites” in other places, too. Image Credits: https://www.flickr.com/photos/mikemacmarketing/42271822770/, AION Labs, Elad Malka, Twitter: @WHO, https://www.flickr.com/photos/158301585@N08/43267970922/. Global Health Leaders Call on African Policymakers To Do More to Stop Climate Change 08/04/2022 Paul Adepoju WHO argues that climate-smart initiatives are good for health. But the health sector receives less than 1% of international climate finance, said Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC). Global health leaders have repeatedly called for stepped up investments to both slow down climate change and recognize the health co-benefits of more climate action. But political leaders, including those in low and middle-income countries, still need to do more, Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC) told Health Policy Watch in a briefing on Thursday, World Health Day. Meanwhile, WHO’s Regional Director for Africa, Matshidiso Moeti, enjoined African governments to “prioritize human wellbeing in every strategy and decision,” including halting fossil fuel expansion that ultimately will boomerang on the countries concerned. “I’d like to take this opportunity to call on an African governments to prioritize human wellbeing in every strategy and decision to halt new fossil fuel exploration and subsidies, institute taxes for polluting firms and to implement the WHO air quality guidelines for example,” said Moeti, speaking on this year’s World Health Day theme, ‘Our Planet, Our Health.’ Added Cissé, countries that harness more of their own national and local policies, innovations and resources can make a difference. “Countries can go for some financial incentive policy at a national scale that includes taxes and subsidies; they can also have some innovative policies regarding insurance. They can also give some small scale financial products to low income and other households,” Cissé said. Support to health sector less than 1% of international climate finance Experts are increasingly aware of the multi-faced impacts of the climate crisis on health – as well and the increased precarity of health in the face of deforestation and biodiversity loss as well as unhealthy foods production – which are also driving climate change. So far, however, support to the health sector for climate action still comprises less than 1% of international climate finance investments, Cissé said, speaking at a WHO African Region World Health Day briefing. Health co-benefits of climate mitigation strategies – for instance fewer air pollution-related deaths from cleaner energy investments, also go uncounted in climate strategies. This, despite health being mentioned as a priority in 54% of countries’ Nationally Determined Contributions (NDCs), which are the main instruments now being used for global climate pledges to reduce harmful emissions, under the UN Framework Convention on Climate Change. Cissé who works with the Swiss Tropical and Public Health Institute at the University of Basel in Switzerland, noted that this reflects the low priority still being given to climate change in the context of health. World Health Day at a time of heightened conflict and fragility Joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra (center) and WHO Director-General Dr Tedros Adhanom Ghebreyesus (right) This year’s World Health Day, which marks the April 7, 1948 date of WHO’s founding, comes at a time of both heightened political conflict and greater ecosystem fragility, noted WHO Director-General Dr Tedros Adhanom Ghebreyesus. He was speaking at a joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra. “The pandemic has highlighted the intimate links between the health of humans, animals and the environment. And yet, we’re rapidly making the planet on which all life depends and inhabitable… “The climate crisis is a health crisis,” Tedros said at the Thursday briefing, which concluded a series of face-to-face meetings this week with US Administration officials – the first since President Joe Biden’s inauguration last year. ”Air pollution kills 7 million people every year. And 99% of the world’s population breathes unhealthy air mainly as a result of burning fossil fuels,” Tedros added. (see related story) “Our warming world is facilitating the spread of mosquitoes and diseases they carry. Extreme weather events, biodiversity loss, land degradation, and water scarcity are displacing people and damaging their health,” Tedros said. “Systems that produce highly processed, unhealthy foods are driving a wave of obesity, increasing cancer and heart disease, and generating one-third of greenhouse gas emissions. “As the world recovers from the pandemic we have a choice: we can go back to the way things were or we can change course. We can create societies, economies and products that nurture health and well being, and stop subsidizing those that destroy – because we cannot afford to pump carbon into the atmosphere at the same rate, and still breathe clean air. “We cannot afford the same patterns of consumption and expect less diabetes, hypertension, heart disease and cancer. We must choose. We cannot afford ever-deepening inequalities and expect continued prosperity. We must choose.” Half new fossil fuel exploration and subsidies, prioritize health, says WHO Regional Director Water shortage in Ethiopia. Population exposure to heat is increasing due to climate change. Globally, extreme temperature events are observed to be increasing in their frequency, duration, and magnitude. In Africa, one of the regions of the world that is worst affected by climate change, extreme weather events are having ever greater impacts on food security, water access, and related to that, nutrition and disease transmission. Of the more than 2000 public health events recorded in the African region between 2019 and 2020, more than half were climate-related, said Moeti, speaking from WHO’s Regional Office in Brazzaville. This, she said, represented a 25% increase compared with the previous decade. “In Africa, diarrhoeal diseases are the third leading cause of death and illness in children younger than five, which could be preventable with safe drinking water, adequate sanitation and hygiene, and installation,” Moeti said. “Our analysis showed that waterborne diseases, mainly due to cholera outbreaks, accounted for 40% of climate-related health emergencies in the past 20 years.” In urging African governments to adopt cleaner, healthier policies, she said the main motive is really self-preservation. “Älthough Africa contributes the least to global warming, the continent bears a disproportionate burden of the consequences,” said Moeti. “It’s up to every one of us to promote and support multi-sectoral interventions that address the threat of climate change, while helping to better prepare for future health shocks like the COVID-19 pandemic.” Image Credits: Oxfam East Africa. 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.
With COVID Vaccine Supply Outstripping Vaccination Rates, Pharma Giants Question Pursuit of IP Waiver 13/04/2022 Kerry Cullinan IFPMA Director General Thomas Cueni (foreground) with moderator Claire Doole and Albert Bourla, David Ricks and Bill Anderson on screen. Pharmaceutical giants have questioned why a waiver on intellectual property (IP) rights for COVID-19 vaccines is still on the table when they are battling to find markets for their vaccines amid order cancellations – including from the Africa Centre for Disease Control. “I’m stunned that the proposed IP waiver is still being debated while supplies of vaccines are far outstripping demand and some factories have been put to a halt because of missing orders,” Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) told a media briefing on Wednesday. With almost a billion vaccines now being produced every month, countries’ lack of capacity to vaccinate is now the main barrier to stopping COVID-19, added Cueni. In the first quarter of the year 13.7 billion vaccine doses were delivered and 11 billion doses administered, said Cueni. “Now orders are slowing down. Countries as well as organisations such as Africa CDC, are not only asking for orders to be delayed but are cancelling them,” added Cueni. “Leading voices are still calling out vaccine scarcity. I do understand the concern. Vaccines are not reaching all those who need them. But the cause is no longer the lack of supplies. It’s scarcity of vaccination, which is due to the lack of country readiness, absorption capacity and the lack of resources needed to get the vaccines into arms.” Countries’ lack of capacity Pfizer CEO Dr Albert Bourla also weighed in on country capacity, saying that the US government was offering 200 million free doses to the poorest countries of the world but they lacked the capacity to administer the vaccines. “The problem is not if there is availability or access to pricing. The problem is that the infrastructure of these countries is very poor, so they cannot absorb them. They cannot run a vaccination campaign,” said Bourla. Bourla added that one of the pandemic’s key lessons was that more attention should have been paid to preparing countries to vaccinate people. He also described any move to remove IP on vaccines as “insane”, while Roche CEO Bill Anderson described it as “unproductive”. Eli Lilly CEO David Ricks warned that pharmaceutical companies and investors would “never have invested” in trying to develop COVID-19 vaccines “if there was not the promise of IP”. “The next investments on the unknown technology which we can repurpose for the next pandemic won’t be made if investors believe that IP will be undermined,” warned Ricks. “What is a patent? It’s a promise to disclose our inventions in return for a period of exclusivity,” added Ricks. “You’ll get much less disclosure about inventions actually as a result of an IP waiver. There’ll be a strong incentive to retain know-how, retain the recipes for what we do, much like you see in some other industries.” Collaboration successes Bourla said one of the best aspects of the pandemic had been the collaborations between different the industry partners, where competitors worked together, as we as public-private collaboration, particularly with regulators. He commended particularly the US Food and Drug Administration, the European Medicines Agency and the Canadian, Israeli and Japanese regulators for their speedy reviews of industry data. “What did not help was the politicisation – if you take a vaccine or not, or wear a mask or not. Tthat created tremendous damage to the global health,” said Bourla. At the IFPMA briefing (clockwise): Pfizer CEO Albert Bourla, IFPMA Director General Thomas Cueni and moderator Claire Doole, Roche CEO Bill Anderson and Eli Lilly CEO David Ricks Future COVID vaccines The IFPMA noted that there was “increasing acceptance that society will have to live with COVID-19”, and that continued innovation remains essential to expand on the 10 vaccines that have so far received WHO Emergency Use Listing approval and the 18 different treatments that have been approved in the UK, USA, and EU. Bourla said that Pfizer and Moderna were working on “multivariant” vaccines but this was “very challenging”, as was developing a COVID-19 vaccine that offered robust protection for at least a year. He hoped this would be ready for testing in the third quarter of the year. COVID-19 Pandemic Still Poses a Danger Despite Lower Case Rates, Says WHO 13/04/2022 Aishwarya Tendolkar A COVID-19 vaccination being administered in Senegal. COVID-19 affiliated deaths last week were the lowest on record globally since the pandemic began two years ago. But the World Health Organisation (WHO) today emphasized that the pandemic remains a public health emergency and we must not drop our guards. “This is the moment to work even harder to save lives,” said Dr Tedros Adhanom Ghebreyesus, the Director-General of WHO, at a press briefing on Wednesday in Geneva. “This virus has over time become more transmissible and it remains deadly, especially for the unprotected and unvaccinated that don’t have access to health care and antivirals. The best way to protect yourself is to get vaccinated and boosted when recommended,” he said. The briefing comes at the end of a meeting of the WHO Emergency Committee convened under the International Health Regulations (IHR). The committee discussed the capacities of states to respond to the pandemic, the problem of vaccine inequity, reduced testing and monitoring, and raised concerns about the inappropriate use of antivirals that may give impetus to drug-resistant variants. Ukraine and Ethiopia In the past 50 days since theRussia invasion of Ukraine, 4.6 million refugees have fled the country, and thousands of civilians, including children, have died, and there have been 119 verified attacks on health care workers. Dr Tedros said that there is a need for humanitarian corridors to enable the delivery of medical supplies, food and water and the evacuation of civilians. He added that to date, the WHO had only received about half of the funding needed to support Ukraine for the first three months. Dr Michael Ryan, WHO’s Executive Director of Health Emergencies, said that there was a high risk of chemical contamination and exposure due to attacks, as well as compromised infrastructure associated with the chemical production, nuclear weapons and energy production. Dr Michael Ryan at the WHO Press Briefing. “We’ve been doing training and other support to the authorities in Ukraine in preparation for such an event. This is very different from the intentional use of chemicals as a weapon in war, which is against international Law and is a war crime,” said Ryan. This comes on the back of reports of the use of chemical weapons in Mariupol. With respect to Ethiopia, Tedors said that the siege by the Ethiopian and Eritrean forces continues to avert the humanitarian calamity and thousands of people from dying. Tedros, who is an Ethiopian and a former Minister of Foreign Affairs, said that the Tigray crisis is one of the most alarming humanitarian crises of our times. “But the world is not treating the human race the same way. Some are more equal than others,” he said referring to the negligible attention received by Afghanistan, Ethiopia, Yemen, and Libya versus the attention that is meted to Ukraine currently. Newer variants According to Dr Maria Van Kerkhove, WHO’s Technical lead on COVID-19, the new sub-variants of the Omicron variant– BA.4 and BA.5– have been reported from a number of countries, including South Africa, in Europe. She said that more sequencing and concerted global efforts to track and share the data on the virus are needed to understand the characteristics of the variants. Responding to the concerns about the reduced testing and tracking of COVID-19 cases, Ryan said that it was important to track the virus as it went “underground”. “It will be very, very, very short-sighted at this time to assume that lower numbers of cases mean an absolute lower risk,” he said. “This virus has surprised us before… We need to do our jobs and track this virus as best we can while people get back to living as normal a life as possible. We in the scientific and public health community need to continue to track this virus closely in every single country.” Dr Maria Van Kerkhove,WHO’s Technical lead for COVID-19, Van Kerkhove added that the committee which met today outlined three main scenarios in the modified Strategic Preparedness, Readiness, and Response Plan (SPRRP) publication: a best case, a worst case, and a base case in terms of outlining what virus evolution and changes and how our countermeasures will react or react to those. There is also a fourth scenario, called ‘reset’ where there is so much change in the virus there will be a population that is susceptible again, and “it resets us.” Vaccinate, vaccinate, vaccinate The updated SPRRP report highlights the need to achieve national COVID-19 vaccination targets in line with global WHO recommendations of at least 70% of all countries’ populations vaccinated by the start of July 2022. “Countries really must start looking at their data breakdown by age and sex,” said Dr Soumya Swaminathan, WHO’s Chief Scientist, while highlighting the importance of boosting the population over the age of 60. Swaminathan added that a majority of countries plan to meet the 70% target, but a handful of countries have set their goal at less than 40%. “ Many of these countries have competing health priorities and so we need to make sure that as COVID vaccine uptake is expanded, scaled up, strengthened, and routine immunization services are also strengthened,” said Swaminathan. Swaminathan mentioned that COVAX has the capability to cater to the vaccination needs of the vulnerable population, but there needs to be more focus on making sure the older, more vulnerable population is catered to and not left out despite the inequitable vaccine situation currently. “The inequity is not just in the overall distribution of vaccines, it is also occurring within countries in terms of not reaching those most likely to benefit from the vaccine and that’s particularly acute,” said Ryan. He added that while 85% of the population over 60 years of age in Europe is fully vaccinated, the number for the same metric stands at 25% in Africa. “If we fail to vaccinate everyone, if we fail to continue diagnosing, if we fail to find the people who can benefit from treatment, then we will fail in the future, and in the next pandemic. So our success now will determine a successful future,” Ryan said. Image Credits: Flickr – Trinity Care Foundation, Georges Yameogo.. Global Health Matters: Around the World of Public Health in Audio 13/04/2022 Maayan Hoffman Global Health Matters podcast host Dr. Garry Aslanyan, TDR After Dr Garry Aslanyan became an avid follower of podcasts, he realized there was a dearth of material from the genre in his own global health field. So he set out to fill that gap with a new series featuring public health professionals and policymakers from around the world who have made a difference – and can inspire others as well. The Global Health Matters podcast hosted by Aslanyan, a public health professional with TDR, the Special Programme for Research and Training in Tropical Diseases, co-sponsored by UNICEF, UNDP, the World Bank and WHO, is now entering its second season of broadcasts. It features a diverse mix of themes and line-up of speakers – has picked up an audience of followers in places as diverse as Yemeni villages and Ulaanbaatar, Mongolia. The first episode of Season 2 was launched on Tuesday, April 12. It focuses on “Championing Health Equity in South Africa.” “The podcast gives people a unique peek into the experiences of people who are just like them,” Aslanyan told Health Policy Watch. “Listeners can relate to the guests and their experiences and compare what they themselves are living through – they can think, ‘can I do this?’ or ‘how does that work?’ or ‘what can this mean for me in my own setting or country?’” The podcast began at the height of the COVID-19 pandemic, when new, virtual information tools became all the more important to people confined for days and weeks at home. The podcast series has already covered a broad range of innovative and inspiring research topics – from climate change and health to science communication and the challenge of ‘decolonizing global health.’ With a focus on sharing perspectives and voices from low- and middle-income countries, the series has already been downloaded more than 11,000 times by listeners in more than 130 countries, Aslanyan said. “The hope is to inspire listeners to do something in their day job with the information they heard,” Aslanyan said. South Africa at the nexus of the global health equity debate This week’s episode on “Championing health equity in South Africa” takes a long look at the country’s COVID vaccine campaign, whose successes and setbacks were a weathervane for the rest of Africa, as well as its precedent-setting examples in advocating for HIV medicines access, in light of the recent pandemic. “As of early March, 74% of those in high-income countries have been fully vaccinated against COVID-19, compared with just 11% of people in low-income countries. As the world commits to global access to medicines and vaccines, is this just on paper or a reality?” the podcast teaser states. “Can South Africa’s experience with tackling HIV/AIDS and COVID-19 point to future solutions for other low- and middle-income countries? How has intellectual property rights affected development of vaccines across Africa?” Appearing on the podcast are three guests: human rights lawyer and activist Fatima Hassan; UNDP policy specialist Judit Rius Sanjuan; and Petro Terblanche, Managing Director of Afrigen Biologics, host of the new mRNA hub in South Africa. Season 2 of Global Health Matters launched this week: Championing Health Equity in South Africa. The goal: To inspire Aslanyan said he started the series after becoming an active listener of podcasts himself. He fell for the audio genre because it runs against the current of 30-second social media soundbytes, providing more thoughtful and detailed coverage of issues in a digestible format – that listeners can tune into while they are travelling or doing something else. But when he searched for something that “really covers global health, I did not find much” – especially not one that featured voices from low- and middle- income countries. So, he and his team decided to start their own series. “The ability to get a more insightful, in-depth understanding of a topic is why this medium is appealing. And for us at TDR, most importantly, this allows people from around the globe to learn from the experiences of others and apply them to their own reality,” said Aslanyan. Although WHO’s Regional Office for Europe offers a ‘Health in Europe’ podcast, and WHO headquarters features a popular Science in Five video series, Global Health Matters is the only broad-based and regular global health podcast featured by WHO, where TDR is based. Aslanyan has postgraduate training in public health and health policy and systems. While not a trained media professional, he was driven by a clear public health mission: to inspire his colleagues in the field. “You may not immediately think somebody trained in public health to host a podcast, but I have done all kinds of work for organizations focused on global health,” Aslanyan explained. “I also have experience in innovation and advocacy and have worked in government departments in Canada before moving to Geneva where I really pushed the boundaries of national health.” He said public health professionals need to be knowledgeable but also able to present things in a way that galvanizes the public around different causes. He had not thought of himself as that person before starting Global Health Matters, but since launch last year he hears from listeners that this is exactly the role he and his guests are fulfilling. “What makes me think that the podcast medium is amazing is the way that we reach cities, towns and villages in the most remote parts of the world, which is VERY satisfying – we know that from our stats,” Aslanyan says. What were some of the most popular episodes last year? “COVID-19 in Africa: the role of research” helped debunk some of the myths around why there was less virus on the continent. Global Health Matters Episode 3. An episode on “Climate change’s impact on health” looked at the impact of climate change on rural areas whose communities’ health and livelihood depends on the environment. A particular focus was on Maasai communities in northern Tanzania, where persistent droughts have made the people vulnerable to sleeping sickness, a disease spread by the tsetse fly. There was also a piece on Communicating science, not fiction featured Natalia Pasternak, founder of Brazilian-based Instituto Questão de Ciência, which combats pseudoscience and advocates for evidence-based treatments. Natalia spoke of her own personal experience as a member of WhatsApp groups for mothers that took a sudden turn into vaccine skepticism. And thousands of kilometers away, in the Western Pacific, Navigating digital health waves featuring Dr Alvin Marcelo, Executive Director of the Asia eHealth Information Network, explained how the Philippine government allowed open access to data from COVID-19 tests, creating a big opportunity for health researchers and services, for instance better matching of COVID-19 test results from particular locations with availability of hospital bed spaces. Natalia Pasternak, founder of Brazilian-based Instituto Questão de Ciência Dr Alvin Marcelo, Executive Director of the Asia eHealth Information Network. “Of course, we get feedback on every episode,” Aslanyan said. “It seems all of them have touched, inspired or at least piqued the interest of our listeners.” He said that he and his team at TDR stepped into podcasting with no experience but they have already learned a lot. Season 2 builds on last year’s, bringing in additional topics such as science diplomacy, corruption in health, migration and health and diversity in global health. Aslanyan said he also hopes to add an even greater variety of personalities to the podcasts, including, potentially, some guests who are public health service recipients rather than providers. He added that two universities in the global North and South are using some podcast episodes to assist students in understanding complex public health subjects – a testimony to the information and clarity being provided by the show. “We think it gives learners the ability to relate to the topics they are studying,” Aslanyan said. In terms of the spread and reach of his audience- it’s both surprising and satisfying, Aslanyan adds. “Sometimes I look at the analytics data showing the people listening to the podcast, and I think, my gosh, who are these eight people in that small city in Yemen who listened to me? I have no idea who they are, but they are there, in a place I don’t know, and I imagine they are probably working in public health.” The first episode of Season 2 launched on Tuesday April 12. Find it here. Link here to all Season 1 episodes of Global Health Matters. Find it on YouTube Championing Health Equity in South Africa Follow @TDRnews on Twitter, TDR on LinkedIn and @ghm_podcast on Instagram for updates about upcoming shows. Image Credits: WHO, GHM Show , GHM. Championing Health Equity in South Africa – Global Health Matters Podcast Series 13/04/2022 Editorial team The second season of the Global Health Matters podcast series kicks off with a close-up look at South Africa’s health equity initiatives and champions. Health Policy Watch will be featuring episodes from the series throughout the coming year as part of a TDR-supported series. As the world commits to equitable access to medicines and vaccines, is this just on paper or a reality? In the case of COVID-19, as of early April 2022, 74% of people in high-income countries had been fully vaccinated, compared with just 15% in Africa and 11% of people in low-income countries worldwide. With 30% of people fully vaccinated, South Africa, has one of the highest COVID vaccination rates in sub-Saharan Africa. And it has been an African leader in the manufacture of COVID vaccines, as well as a leader in the global campaign to waive intellectual property rights on COVID vaccines, tests and treatment – not to mention the historic role it played a generation ago in the legal battles that paved the way for the widespread manufacture of low-cost, generic antivirals for HIV treatment. Can South Africa’s experience with tackling HIV/AIDS and COVID-19 point to future solutions for other low- and middle-income countries? And how has the state of play regarding intellectual property rights for COVID health products affected development of vaccines across Africa? Global Health Matters podcast host Garry Aslanyan fields these and other questions to three leading South Africans scientists, policymakers and health activists, including Fatima Hassan (founder of the Health Justice Initiative), Petro Terblanche (Managing Director of Afrigen Biologics), and Judit Rius Sanjuan (Policy Specialist at UNDP). Click here to catch this episode, the first of the second season of TDR’s Global Health Matters podcast. Find it on YouTube: Championing Health Equity in South Africa Link here for all Season 1 episodes of Global Health Matters. Historic Public Hearings on WHO Pandemic Instrument; Some Unhappiness with Process 12/04/2022 Kerry Cullinan The last Ebola patient leaves a treatment centre in the Democratic Republic of Congo at the end of March 2021, marking the countdown to declaring the end of that pandemic. The World Health Organization (WHO) convened public hearings for only the second time in its history on Tuesday, asking interested parties what substantive issues should be contained in its proposed international instrument on pandemic preparedness and response. The first and only other WHO hearings were held 22 years ago in the run-up to the adoption of the Framework Convention on Tobacco Control, according to WHO principal legal officer Steven Solomon. Welcoming the public hearing, WHO Director-General Dr Tedros Adhanom Ghebreyesus said that informed opinion and active public cooperation are of the utmost importance to improve health, and it was important to learn from the COVID-19 pandemic to ensure the world is “better prepared” for the next pandemic. Tedros had been mandated by last year’s World Health Assembly Special Session to convene public hearings to inform the work of the Intergovernmental Negotiating Body (INB) which is in charge of negotiating the pandemic instrument or treaty. INB co-chair, South Africa’s Dr Precious Matsoso, described the hearings as “remarkable” and “historic”. Dr Precious Matsoso, INB co-chair Narrow responsibility However, the Civil Society Alliance for Human Rights in the Pandemic Treaty warned that the consultative process risks being “inadequate”. “While this week’s public hearings reflect the INB’s stated objective to consult the public to some extent, it has interpreted its responsibility to do so very narrowly,” according to the alliance. “The INB has allocated minimal time to engaging with the wide range of stakeholders who could inform the process and improve both the legitimacy and quality of the Treaty that emerges.” Dr Meg Davis, from the Global Health Centre at the Graduate Institute in Geneva, also said that participants had been given no indication of whether or how their submissions would be included in the negotiations and recommended policymaking models to ensure meaningful civil society engagement. A number of organisations gave two-minute speeches focusing on a wide range of issues including ‘One Health’, research and development (R&D) and intellectual property rights at the hearings, which continue on Wednesday and then reconvene in mid-June. Equity means sharing Research and Development Professor Suerie Moon, co-director of the Global Health Centre at the Graduate Institute in Geneva. All member states have committed to equity at the heart of any pandemic instrument, but Professor Suerie Moon, co-director of the Geneva Graduate Institute’s Global Health Centre, told the hearings that “equity requires collective research and development of vaccines, drugs and diagnostics”. Pointing out that COVID-19 has led to the development of technology transfer hubs in South Africa and the Republic of Korea, Moon warned that “there’s a risk that new factories will sit idle in the next emergency unless the new international instrument forges agreement on obligations to share knowledge, data and intellectual property before and during future emergencies”. “It’s unlikely, however, that countries or companies will do so out of the goodness of their hearts,” added Moon. “To make such sharing feasible, we have to tie it to commitments to jointly finance research and development to share pathogen samples and genomic sequencing data. In other words, the key idea is collective research and development for collective benefit.” Acknowledging that intellectual property was a difficult issue, Moon nonetheless said that if equitable access was to become a reality “the new instrument must include the nuts-and-bolts provisions to make sharing technology for pandemics the new normal”. To address IP, Knowledge Ecology International (KEI) recommended that governments should “agree to collectively use exceptions to intellectual property rights that are permitted in existing trade agreements and treaties”. “A model for this is the WIPO Marrakesh Treaty for the Blind, which mandates its members to use exceptions in copyrights to enhance global access to works made accessible to persons who are blind or have other disabilities,” according to KEI’s James Love. KEI also proposed “a robust chapter on transparency”, adding that “the lack of transparency in many areas for the current pandemic is an appalling and unnecessary policy failure, and one that both makes it more difficult to manage a pandemic response, and undermines the public’s trust in institutions”. Rachael Crockett from the Drugs for Neglected Diseases initiative (DNDi) stressed the need to co-ordinate R&D as a substantive element of the new instrument. DNDi wants R&D priority setting, and “globally agreed norms and binding rules that govern the R&D process, including transparency and open sharing of research, data, knowledge, technology, and equitable allocation of health tools”. Sharing pathogens IFPMA’s Grega Kumer Grega Kumer from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) said “any system should be built on what worked well during the COVID pandemic, in particular, immediate sharing of pathogens and a robust response from the IP based private sector”. The IFPMA presented eight core principles, including that the negotiation process should be “inclusive and transparent, involving the private sector and all critical contributors to pandemic preparedness efforts”. “Any system should allow for immediate access of pathogens and genetic sequence data and correct the negative effects of access and benefit-sharing legislation,” said Kumer. The IFPMA also supports more equitable access to tests, treatments and vaccines “based on medical need, thus enhancing solidarity and facilitating emergency financing to institutions procuring for developing countries”, and the protection of supply chains ”from arbitrary export restrictions and other trade barriers”. “While the public sector might play a larger role in pandemic setting, the system should build on the private sector strengths for R&D, manufacturing and distribution,” he concluded. One Health is key The need for any pandemic instrument to adopt a One Health approach also emerged as a key theme. Dame Sally Davies, speaking for the UN Global Leaders Group on Antimicrobial Resistance (AMR), said that they wanted AMR to be integrated alongside a primary focus on pandemics. “The next pandemic could be drug-resistant, or could depend on antimicrobials to mitigate it,” said Davies, saying that one health surveillance needed to be at the heart of any pandemic treaty to enable “rapid, transparent and responsive protection”. Governance principles The Panel for a Global Health Convention believes the instrument must be governed by four non-negotiable principles, according to Dame Barbara Stocking. “Solidarity, because we’re all in this together, and solidarity is in our own self-interest,” explained Stocking. “Equity: there must be equal access to vaccines and treatments, but also an equal voice in decision-making. Transparency in reporting data and samples. Accountability, as the lack of accountability of countries is the fundamental reason that we are in disarray.” The hearings continue at 8am CET on Wednesday and can be followed live. Image Credits: WHO African Region. Nineteen More Attacks on Ukraine’s Health Facilities Since Friday: WHO 11/04/2022 Kerry Cullinan Ukraine operating theatre destroyed The World Health Organization (WHO) has verified 108 attacks on health care in Ukraine as of Monday in which 73 people have died and 51 have been injured. That is 19 more attacks on health facilities than the already deadly toll of 91 attacks that had been verified by WHO as of early Friday afternoon, and as reported at a press conference by WHO’s Regional Director Hans Kluge in Lviv. .@WHO has verified 5 additional reports of attacks on health care in #Ukraine. As of 11 April, 108 attacks on health care in Ukraine have been verified, causing 73 deaths and 51 injuries. We are outraged that attacks on health care are continuing. pic.twitter.com/8GNUQZFiK9 — WHO Ukraine (@WHOUkraine) April 11, 2022 Meanwhile, the Office of the UN High Commissioner for Human Rights (OHCHR) has recorded 1,793 civilian deaths and 2,439 injuries since the start of the Russian invasion on 24 February and Sunday. Most of the civilian casualties have been caused by “explosive weapons with a wide impact area”, including shelling from heavy artillery and rocket, missile and air strikes. https://data.humdata.org/visualization/ukraine-humanitarian-operations/ “OHCHR believes that the actual figures are considerably higher, as the receipt of information from some locations where intense hostilities have been going on has been delayed and many reports are still pending corroboration,” according to a statement from the office. “This concerns, for example, Mariupol (Donetsk region), Izium (Kharkiv region), Popasna (Luhansk region), and Borodianka (Kyiv region), where there are allegations of numerous civilian casualties. These figures are being further corroborated and are not included in the above statistics.” According to the Prosecutor General’s Office of Ukraine, 176 children had been killed and at least 336 injured as of Sunday. Image Credits: WHO. Pfizer Refuses Cooperation with DNDi on Study of Paxlovid Treatment Adapted to Low Income Countries 08/04/2022 Elaine Ruth Fletcher & Kerry Cullinan Paxlovid Pfizer has so far refused an invitation from the Geneva-based Drugs for Neglected Diseases Initiative (DNDi) to cooperate on a study exploring whether the treatment window of its successful antiviral drug, Paxlovid, could be extended from 5-7 days using another drug compound in addition, Dr Nathalie Strub-Wourgaft, Director of DNDi’s COVID-19 Response, told Health Policy Watch. DNDi wants to test if the key active ingredient of Paxlovid, nirmatrelvir, could be offered in combination with an inhaled corticosteroid, budesonide, in order to extend the treatment window of the life-saving COVID treatment by two more days, Strub-Wourgaft said in an interview. Extending the treatment window is critical for patients in low-income countries because the currently-approved formulation of Paxlovid must be commenced within 3-5 days of COVID symptoms. Meanwhile ANTICOV, a major DNDi-sponsored trial of COVID treatments underway in ten African countries, has revealed that one-half of COVID patients present for treatment after the five day cut-off date. ANTICOV clinical trial. That makes the current Paxlovid combination less than suitable for low- and middle-income country (LMIC) conditions, said Strub-Wourgaft. She is one of the coordinators of the ANTICOV Consortium, a group of 26 African and global research organizations engaged in the clinical trial research on novel COVID drugs for LMICs. On 15 March, DNDi issued a public statement expressing its concern that “efforts to conduct urgently needed studies in low- and middle-income countries (LMICs) utilizing the novel oral antiviral, nirmatrelvir/ritonavir (Paxlovid), are being blocked by Pfizer, which developed the drug. Paxlovid, which uses the common HIV drug ritonavir in combination with nirmatrelvir, has been found to reduce the risk of hospitalization or death by a stunning 89% in patients at high risk of severe COVID-19 disease. But the treatment needs to be taken within three to five days of patients developing symptoms. According to DNDi, “an interim analysis done in the context of the ongoing ANTICOV clinical trial conducted in 10 African countries showed that of the 1180 patients enrolled, more than half present for care after day 5. “To overcome this challenge, it is necessary to explore whether using Paxlovid with other drugs could widen the ‘treatment window’ to at least seven days,” DNDi said in its statement. DNDi also wants to investigate if the drug could be “beneficial for immune-suppressed patients who are the most vulnerable to disease progression but were excluded from phase 3 trials.” DNDi, a Geneva-based not-for-profit research and development organisation, works to deliver new treatments on neglected diseases and serving neglected groups in low- and middle-income countries. Still looking for ways to access nirmatrelvir DNDi drug development. Strub, in her comments to Health Policy Watch, suggested that DNDi, which has a good track record of building cooperation with the pharma industry, was still trying to obtain the drug somehow – or even persuade Pfizer to collaborate. “We would like to test nirmatrelvir/ritonavir in combination, as well, with inhaled budesonide or maybe fluoxetine (brand name Prozac),” said Strub-Wourgaft. “We issued a statement to say that we had asked Pfizer to get access to nirmatrelvir, to work with us on this trial. They denied. We’re continuing to try to get access to this drug.” “We think this [combination] would extend the window of treatment to seven days of symptoms. In the study that they [Pfizer] have done, which is a great study showing really fantastic results, they looked at patients who had five days of symptoms before they were enrolled. “And we have seen for now, in our study in Africa, that half of the patients come after five days of symptoms,” she said. Such delays are typical because COVID diagnosis and treatment services are less widely available and it thus takes people longer to get diagnosed, even if they are symptomatically ill. “There are critically important public health research questions that must be answered quickly – particularly in low- and middle-income countries where access to vaccines remains low,” added Strub-Wourgaft, in the DNDi statement. “It is difficult to understand any rationale for refusing to cooperate in the midst of a global pandemic, and this sets a dangerous precedent since there are many other promising antivirals in the pipeline and these novel treatments will also require follow-on research to determine their optimal use in resource-limited settings.” MPP deal with Pfizer – not enough Pfizer recently signed a deal with another Geneva-based group, the non-profit Medicines Patent Pool, that will allow 35 new manufacturers to produce and supply generic versions of Paxlovid to some 95 low- and middle income countries – in what the company has said is a move to lower the drug’s cost and expand access in low-income countries. But that deal has also been criticised for failing to cover dozens of other middle-income and upper-middle income countries that will have to purchase patented versions of the drug. Although Pfizer had also said that it would create a tiered pricing system for Paxlovid, drug price advocates say that the price remains too high in many settings. In the United States, the government pays Pfizer about $530 for a five day course, although the pills also are in short supply in some US communities. In addition, most of Pfizer’s Paxlovid supply for the first half of 2022 has already been bought up by rich countries, meaning that LMICs will only be able to get about 10 million doses of the drug in the near term. Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates However, even considering the MPP deal and other preferential pricing mechanisms, the fact remains that the version of Paxlovid currently being produced is not an optimal fit for many LMICs, Strub-Wourgaft said. “So for now, if we were to be able to give them Paxlovid, under the current conditions, half of them would not even have access,” she told Health Policy Watch. MPP deals with generic manufacturers may not enable supplies to ANTICOV DNDi is also concerned about the potential difficulty of obtaining generic versions of Paxlovid to conduct the new ANTICOV combination studies, the company has said. “The terms of the Pfizer/Medicines Patent Pool (MPP) licensing agreement to the new generics manufacturers could be interpreted to mean that sub-licensees cannot provide nirmatrelvir/ritonavir for use in the sorts of combination studies that DNDi and others wish to conduct, unless they have explicit written approval from Pfizer. “Some generic manufacturers are also encountering difficulties obtaining Paxlovid as a ‘reference drug’ so that they can conduct the necessary bioequivalence studies to show regulators that their generic version has the same effect in the body, effectively blocking availability of generics for both research and clinical use”, DNDi added in its statement. It has therefore asked Pfizer to not only provide access to nirmatrelvir/ritonavir (Paxlovid) for the DNDi-coordinated ANTICOV trial and other relevant clinical trials, but also to: Remove any ambiguities or restrictions in the Pfizer-MPP licensing agreement that could prevent sub-licensees from supplying such research studies (or publicly clarify that no such restrictions exist); Provide access to Pfizer’s originator product as a ‘reference drug’ so that any interested generic manufacturer can conduct the necessary bioequivalence studies for regulatory approval; and Allocate sufficient quantities of Paxlovid specifically for LMICs and remove all barriers to access to generic nirmatrelvir/ritonavir to enable scale up for care and treatment in LMICs. “Every effort should be made to ensure that clinical studies for COVID-19 treatment are conducted in low- and middle-income countries, and that any products developed reach vulnerable populations,” said Dr John Amuasi, head of the Global Health and Infectious Diseases Research Grou at Kumasi Center for Collaborative Research in Tropical Medicine in Ghana and a principal investigator for ANTICOV. “We must not arrive at a situation where research priorities are determined by the actions or inactions of any company.” Pfizer response – committed to well-controlled trials In response to a request from Health Policy Watch, a Pfizer spokesperson did not provide any clarification of the reasons behind the company’s refusal to participate in the DNDi trial – aimed a making the treatment more suitable to low-income settings. “Pfizer appreciates the importance of gathering additional data and information for governments to help maximize the public health response to the COVID-19 pandemic,” said the spokesperson, adding that the company is committed to “well-controlled, hypothesis-driven clinical studies that can provide data that will be accepted by global regulatory agencies. “Additional studies of PAXLOVID are underway or are being explored, and we will continue to share information as we have it,” the spokesperson added. In addition, “Right now, we are focusing our efforts and resources in a way that maximizes availability of our overall supply, to help ensure access to patients as quickly as possible,” the spokesperson said, noting that the company remains “confident” in the clinical trial results, which showed an 88-89% efficacy rate for the drug, when it was administered to non-hospitalized, high-risk patients within 3-5 days of symptom onset. -Updated 9 April with correction on the price of Paxlovid paid by the US government for patients in the USA and on 11 April with details of Pfizer response. Image Credits: Bobbi-Jean MacKinnon, DNDI/Twitter, DNDi. Artificial Intelligence ‘Boot Camp’ Aims to Accelerate Drug Discovery 08/04/2022 Maayan Hoffman Machine learning is playing an increasingly important role in computing and artificial intelligence. TEL AVIV – Ninety percent of drug candidates fail in clinical trials because of unexpected safety issues or lack of efficacy in human subjects, according to Noga Yerushalmi, Investment Director at M Ventures, the strategic, corporate venture capital arm of Merck. There have been dramatic improvements in omics technologies – that is the collective technologies used to explore molecular behaviour, such as genomics, proteomics, metabolomics, metagenomics and transcriptomics. And this is enabling scientists to analyze potential drug targets more efficiently in terms of their potential impact on a pathogen or disease. But there is no automated solution that harnesses all preclinical data in a way that allows for a reliable assessment of the clinical trial readiness of a new drug candidate. Now, some pharma and research initiatives are hoping to change that, among them AION Labs. Together with its German partner BioMed X, the Israeli-based research alliance, hosted 15 teams of computational biologists, AI researchers and biomedical scientists for a ‘boot camp’ that aims to speed up the drug discovery process and lower costs – harnessing AI technologies in novel ways. Mission: identify critical safety issues before expensive clinical trial stage The latest boot camp cohort The teams were charged with making a proposal for the development of a versatile, next-generation computational platform that can identify hidden safety liability and lack of efficacy, and close identified gaps in the drug candidate pre-clinical data package. “The big problem in drug discovery and development is that after a lot of experiments have been done and we have a new drug candidate, many of these candidates fail in very expensive clinical trials in humans,” Dr. Christian Tidona, founder and managing director of the BioMed X Institute told Health Policy Watch. “That’s because humans are different from mice or a dish in the lab.” The challenge is that pharma companies usually only discover that a drug candidate either is not safe or will not work after years of effort and hundreds of millions of dollars of investment. Companies can invest $5 billion and 12-years’ time, on average, Tidona said, to create the next “blockbuster drug.” “When one thinks about these numbers, he can imagine why some of these drugs are so expensive. Could an AI platform predict if a drug is really ready for the clinic and, if not, tell us what was missed before we go to trial?” Tidona asked. “This is the question. “If drugs can be made more efficiently, medicines can become cheaper and more people in all parts of the world could afford them,” he said. Solving therapeutic challenges Kahina Lang, head of Strategic Innovation at Merck Group, addresses the candidates at the AION Labs boot camp. Based in Rehovot, not far from the the famed Weizmann Institute, AION brings together some of the biggest names in pharma, including AstraZeneca, Merck, Pfizer, and Teva, with young biotech inventors and entrepreneurs, to crack biomedical research challenges together and in a novel way. “We work with each of our pharma partners separately and then together to identify the top research challenges that solving would be majorly impactful for the industry at large,” AION CEO Mati Gill told Health Policy Watch. Then, AION looks for innovators and scientists to develop solutions for them. For last week’s boot camp, 15 applicants from around the world were selected to come to Israel and participate. “The winner receives a $2 million investment, mentorship and access to a wealth of data for model training from these four big pharma companies,” Tidona said. “It is more or less paradise for anyone who wants to start a company.” The concept is based on a model Tidona first developed on the campus of the University of Heidelberg in Germany, with a world-wide network of partner locations. If the company succeeds, the technology belongs to it but will be made available for purchase by the pharma partners. ‘Bringing the promise of AI to fruition’ Guy Spigelman of AWS addresses candidates at the AION Labs bootcamp. Merck’s Yerushalmi said that there have been “all kinds of efforts to make the drug development model more efficient – to expedite it,” but until now it has not worked. When computational approaches to research were first introduced, “it brought a lot of promise, but until now it has not brought as much fruit as we hoped. Now, with AI tools and the amount of data pharma and other companies can generate, we do hope we may be able to bring this promise to fruition.” AI is one of the most sophisticated computational tools. AI analysis has brought “ingenious” solutions to other fields, like the automotive industry, she pointed out. “AI tools and big data have proven themselves in so many other cases, I think it will probably work for our industry too,” Yerushalmi said. “Want to make [drug development] more affordable and shorter, so we can bring drugs to the market faster and cheaper for the benefit of humanity.” Finding the most effective antibodies AION will be looking for the next therapeutic antibodies. This most recent boot camp was AION’s second one so far. Earlier this year, it invited computational biologists and biomedical scientists to propose ideas for discovering therapeutic antibodies. “Advances in protein structure prediction, artificial intelligence algorithms, and increased availability of experimentally determined antigen-antibody structures present a unique opportunity for AI-driven antibody discovery,” AION said in a release. In the coming months, it will hold a third boot camp at which computational biologists, bioinformatics and cheminformatics scientists and AI researchers will propose ideas for the development of a next-generation computational platform to optimize antibodies for targeted therapies with enhanced properties, including developability or manufacturability, stability, aggregation, immunogenicity, pharmacokinetics and tissue distribution. “The ultimate solution is an AI platform that receives sequences of binders and generates novel variants with optimized IgG sequences, biophysical and targeting properties,” a background briefing explained. “The goal of the AI algorithm is to make an existing antibody a better drug while reducing design iterations, optimization of cycle times and lowering attrition rates.” CEPI launches AI-based quest for beta-coronavirus vaccine candidate The AION initiative, while pioneering in the use of AI for drug discovery, is not the only one. On Thursday, the Oslo-based Coalition for Epidemic Preparedness (CEPI) announced that it would provide seed funding of up to US $4.8 million to a consortium to support the AI-based development of betacoronavirus vaccine candidates – the new holy grail for coronavirus vaccines. The research consortium, led by a Norway-based subsidiary of the Japanese NEC Group, which specializes in AI technologies, also includes the European Vaccine Initiative (EVI) and Oslo University Hospital. It aims to establish preclinical proof of concept for an mRNA-based vaccine that protects against a broad range of beta coronaviruses – rather than SARS-CoV2 alone, said CEPI in a press release. NEC will apply its experience in the AI design of immunogens to identify novel vaccine antigens with broad reactivity against beta-coronaviruses. The lead antigens will be selected iteratively and validated in preclinical studies against known beta coronaviruses that already pose a significant epidemic or pandemic risk, such as SARS-CoV, SARS-CoV-2 and MERS-CoV. If the approach is successful, it may also be applicable for developing vaccines against other pathogens in the CEPI portfolio, including ‘Disease X’ – unknown pathogens with pandemic potential that have yet to emerge. What the future holds What the future of AI holds. Tidona, for his part, hopes that AION will spin off 20 new start-ups in the next four to six years. “We are building an innovation ecosystem,” he said, noting that it is attractive to host countries as it provides a draw for youthful talent, which in turn spurs economic development. He added that if the model works well, BioMed X plans to export it to other countries as well. “The focus now is on Israel as our first partner outside Germany,” Tidona said. “But in the future, we hope to have sites” in other places, too. Image Credits: https://www.flickr.com/photos/mikemacmarketing/42271822770/, AION Labs, Elad Malka, Twitter: @WHO, https://www.flickr.com/photos/158301585@N08/43267970922/. Global Health Leaders Call on African Policymakers To Do More to Stop Climate Change 08/04/2022 Paul Adepoju WHO argues that climate-smart initiatives are good for health. But the health sector receives less than 1% of international climate finance, said Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC). Global health leaders have repeatedly called for stepped up investments to both slow down climate change and recognize the health co-benefits of more climate action. But political leaders, including those in low and middle-income countries, still need to do more, Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC) told Health Policy Watch in a briefing on Thursday, World Health Day. Meanwhile, WHO’s Regional Director for Africa, Matshidiso Moeti, enjoined African governments to “prioritize human wellbeing in every strategy and decision,” including halting fossil fuel expansion that ultimately will boomerang on the countries concerned. “I’d like to take this opportunity to call on an African governments to prioritize human wellbeing in every strategy and decision to halt new fossil fuel exploration and subsidies, institute taxes for polluting firms and to implement the WHO air quality guidelines for example,” said Moeti, speaking on this year’s World Health Day theme, ‘Our Planet, Our Health.’ Added Cissé, countries that harness more of their own national and local policies, innovations and resources can make a difference. “Countries can go for some financial incentive policy at a national scale that includes taxes and subsidies; they can also have some innovative policies regarding insurance. They can also give some small scale financial products to low income and other households,” Cissé said. Support to health sector less than 1% of international climate finance Experts are increasingly aware of the multi-faced impacts of the climate crisis on health – as well and the increased precarity of health in the face of deforestation and biodiversity loss as well as unhealthy foods production – which are also driving climate change. So far, however, support to the health sector for climate action still comprises less than 1% of international climate finance investments, Cissé said, speaking at a WHO African Region World Health Day briefing. Health co-benefits of climate mitigation strategies – for instance fewer air pollution-related deaths from cleaner energy investments, also go uncounted in climate strategies. This, despite health being mentioned as a priority in 54% of countries’ Nationally Determined Contributions (NDCs), which are the main instruments now being used for global climate pledges to reduce harmful emissions, under the UN Framework Convention on Climate Change. Cissé who works with the Swiss Tropical and Public Health Institute at the University of Basel in Switzerland, noted that this reflects the low priority still being given to climate change in the context of health. World Health Day at a time of heightened conflict and fragility Joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra (center) and WHO Director-General Dr Tedros Adhanom Ghebreyesus (right) This year’s World Health Day, which marks the April 7, 1948 date of WHO’s founding, comes at a time of both heightened political conflict and greater ecosystem fragility, noted WHO Director-General Dr Tedros Adhanom Ghebreyesus. He was speaking at a joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra. “The pandemic has highlighted the intimate links between the health of humans, animals and the environment. And yet, we’re rapidly making the planet on which all life depends and inhabitable… “The climate crisis is a health crisis,” Tedros said at the Thursday briefing, which concluded a series of face-to-face meetings this week with US Administration officials – the first since President Joe Biden’s inauguration last year. ”Air pollution kills 7 million people every year. And 99% of the world’s population breathes unhealthy air mainly as a result of burning fossil fuels,” Tedros added. (see related story) “Our warming world is facilitating the spread of mosquitoes and diseases they carry. Extreme weather events, biodiversity loss, land degradation, and water scarcity are displacing people and damaging their health,” Tedros said. “Systems that produce highly processed, unhealthy foods are driving a wave of obesity, increasing cancer and heart disease, and generating one-third of greenhouse gas emissions. “As the world recovers from the pandemic we have a choice: we can go back to the way things were or we can change course. We can create societies, economies and products that nurture health and well being, and stop subsidizing those that destroy – because we cannot afford to pump carbon into the atmosphere at the same rate, and still breathe clean air. “We cannot afford the same patterns of consumption and expect less diabetes, hypertension, heart disease and cancer. We must choose. We cannot afford ever-deepening inequalities and expect continued prosperity. We must choose.” Half new fossil fuel exploration and subsidies, prioritize health, says WHO Regional Director Water shortage in Ethiopia. Population exposure to heat is increasing due to climate change. Globally, extreme temperature events are observed to be increasing in their frequency, duration, and magnitude. In Africa, one of the regions of the world that is worst affected by climate change, extreme weather events are having ever greater impacts on food security, water access, and related to that, nutrition and disease transmission. Of the more than 2000 public health events recorded in the African region between 2019 and 2020, more than half were climate-related, said Moeti, speaking from WHO’s Regional Office in Brazzaville. This, she said, represented a 25% increase compared with the previous decade. “In Africa, diarrhoeal diseases are the third leading cause of death and illness in children younger than five, which could be preventable with safe drinking water, adequate sanitation and hygiene, and installation,” Moeti said. “Our analysis showed that waterborne diseases, mainly due to cholera outbreaks, accounted for 40% of climate-related health emergencies in the past 20 years.” In urging African governments to adopt cleaner, healthier policies, she said the main motive is really self-preservation. “Älthough Africa contributes the least to global warming, the continent bears a disproportionate burden of the consequences,” said Moeti. “It’s up to every one of us to promote and support multi-sectoral interventions that address the threat of climate change, while helping to better prepare for future health shocks like the COVID-19 pandemic.” Image Credits: Oxfam East Africa. 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.
COVID-19 Pandemic Still Poses a Danger Despite Lower Case Rates, Says WHO 13/04/2022 Aishwarya Tendolkar A COVID-19 vaccination being administered in Senegal. COVID-19 affiliated deaths last week were the lowest on record globally since the pandemic began two years ago. But the World Health Organisation (WHO) today emphasized that the pandemic remains a public health emergency and we must not drop our guards. “This is the moment to work even harder to save lives,” said Dr Tedros Adhanom Ghebreyesus, the Director-General of WHO, at a press briefing on Wednesday in Geneva. “This virus has over time become more transmissible and it remains deadly, especially for the unprotected and unvaccinated that don’t have access to health care and antivirals. The best way to protect yourself is to get vaccinated and boosted when recommended,” he said. The briefing comes at the end of a meeting of the WHO Emergency Committee convened under the International Health Regulations (IHR). The committee discussed the capacities of states to respond to the pandemic, the problem of vaccine inequity, reduced testing and monitoring, and raised concerns about the inappropriate use of antivirals that may give impetus to drug-resistant variants. Ukraine and Ethiopia In the past 50 days since theRussia invasion of Ukraine, 4.6 million refugees have fled the country, and thousands of civilians, including children, have died, and there have been 119 verified attacks on health care workers. Dr Tedros said that there is a need for humanitarian corridors to enable the delivery of medical supplies, food and water and the evacuation of civilians. He added that to date, the WHO had only received about half of the funding needed to support Ukraine for the first three months. Dr Michael Ryan, WHO’s Executive Director of Health Emergencies, said that there was a high risk of chemical contamination and exposure due to attacks, as well as compromised infrastructure associated with the chemical production, nuclear weapons and energy production. Dr Michael Ryan at the WHO Press Briefing. “We’ve been doing training and other support to the authorities in Ukraine in preparation for such an event. This is very different from the intentional use of chemicals as a weapon in war, which is against international Law and is a war crime,” said Ryan. This comes on the back of reports of the use of chemical weapons in Mariupol. With respect to Ethiopia, Tedors said that the siege by the Ethiopian and Eritrean forces continues to avert the humanitarian calamity and thousands of people from dying. Tedros, who is an Ethiopian and a former Minister of Foreign Affairs, said that the Tigray crisis is one of the most alarming humanitarian crises of our times. “But the world is not treating the human race the same way. Some are more equal than others,” he said referring to the negligible attention received by Afghanistan, Ethiopia, Yemen, and Libya versus the attention that is meted to Ukraine currently. Newer variants According to Dr Maria Van Kerkhove, WHO’s Technical lead on COVID-19, the new sub-variants of the Omicron variant– BA.4 and BA.5– have been reported from a number of countries, including South Africa, in Europe. She said that more sequencing and concerted global efforts to track and share the data on the virus are needed to understand the characteristics of the variants. Responding to the concerns about the reduced testing and tracking of COVID-19 cases, Ryan said that it was important to track the virus as it went “underground”. “It will be very, very, very short-sighted at this time to assume that lower numbers of cases mean an absolute lower risk,” he said. “This virus has surprised us before… We need to do our jobs and track this virus as best we can while people get back to living as normal a life as possible. We in the scientific and public health community need to continue to track this virus closely in every single country.” Dr Maria Van Kerkhove,WHO’s Technical lead for COVID-19, Van Kerkhove added that the committee which met today outlined three main scenarios in the modified Strategic Preparedness, Readiness, and Response Plan (SPRRP) publication: a best case, a worst case, and a base case in terms of outlining what virus evolution and changes and how our countermeasures will react or react to those. There is also a fourth scenario, called ‘reset’ where there is so much change in the virus there will be a population that is susceptible again, and “it resets us.” Vaccinate, vaccinate, vaccinate The updated SPRRP report highlights the need to achieve national COVID-19 vaccination targets in line with global WHO recommendations of at least 70% of all countries’ populations vaccinated by the start of July 2022. “Countries really must start looking at their data breakdown by age and sex,” said Dr Soumya Swaminathan, WHO’s Chief Scientist, while highlighting the importance of boosting the population over the age of 60. Swaminathan added that a majority of countries plan to meet the 70% target, but a handful of countries have set their goal at less than 40%. “ Many of these countries have competing health priorities and so we need to make sure that as COVID vaccine uptake is expanded, scaled up, strengthened, and routine immunization services are also strengthened,” said Swaminathan. Swaminathan mentioned that COVAX has the capability to cater to the vaccination needs of the vulnerable population, but there needs to be more focus on making sure the older, more vulnerable population is catered to and not left out despite the inequitable vaccine situation currently. “The inequity is not just in the overall distribution of vaccines, it is also occurring within countries in terms of not reaching those most likely to benefit from the vaccine and that’s particularly acute,” said Ryan. He added that while 85% of the population over 60 years of age in Europe is fully vaccinated, the number for the same metric stands at 25% in Africa. “If we fail to vaccinate everyone, if we fail to continue diagnosing, if we fail to find the people who can benefit from treatment, then we will fail in the future, and in the next pandemic. So our success now will determine a successful future,” Ryan said. Image Credits: Flickr – Trinity Care Foundation, Georges Yameogo.. Global Health Matters: Around the World of Public Health in Audio 13/04/2022 Maayan Hoffman Global Health Matters podcast host Dr. Garry Aslanyan, TDR After Dr Garry Aslanyan became an avid follower of podcasts, he realized there was a dearth of material from the genre in his own global health field. So he set out to fill that gap with a new series featuring public health professionals and policymakers from around the world who have made a difference – and can inspire others as well. The Global Health Matters podcast hosted by Aslanyan, a public health professional with TDR, the Special Programme for Research and Training in Tropical Diseases, co-sponsored by UNICEF, UNDP, the World Bank and WHO, is now entering its second season of broadcasts. It features a diverse mix of themes and line-up of speakers – has picked up an audience of followers in places as diverse as Yemeni villages and Ulaanbaatar, Mongolia. The first episode of Season 2 was launched on Tuesday, April 12. It focuses on “Championing Health Equity in South Africa.” “The podcast gives people a unique peek into the experiences of people who are just like them,” Aslanyan told Health Policy Watch. “Listeners can relate to the guests and their experiences and compare what they themselves are living through – they can think, ‘can I do this?’ or ‘how does that work?’ or ‘what can this mean for me in my own setting or country?’” The podcast began at the height of the COVID-19 pandemic, when new, virtual information tools became all the more important to people confined for days and weeks at home. The podcast series has already covered a broad range of innovative and inspiring research topics – from climate change and health to science communication and the challenge of ‘decolonizing global health.’ With a focus on sharing perspectives and voices from low- and middle-income countries, the series has already been downloaded more than 11,000 times by listeners in more than 130 countries, Aslanyan said. “The hope is to inspire listeners to do something in their day job with the information they heard,” Aslanyan said. South Africa at the nexus of the global health equity debate This week’s episode on “Championing health equity in South Africa” takes a long look at the country’s COVID vaccine campaign, whose successes and setbacks were a weathervane for the rest of Africa, as well as its precedent-setting examples in advocating for HIV medicines access, in light of the recent pandemic. “As of early March, 74% of those in high-income countries have been fully vaccinated against COVID-19, compared with just 11% of people in low-income countries. As the world commits to global access to medicines and vaccines, is this just on paper or a reality?” the podcast teaser states. “Can South Africa’s experience with tackling HIV/AIDS and COVID-19 point to future solutions for other low- and middle-income countries? How has intellectual property rights affected development of vaccines across Africa?” Appearing on the podcast are three guests: human rights lawyer and activist Fatima Hassan; UNDP policy specialist Judit Rius Sanjuan; and Petro Terblanche, Managing Director of Afrigen Biologics, host of the new mRNA hub in South Africa. Season 2 of Global Health Matters launched this week: Championing Health Equity in South Africa. The goal: To inspire Aslanyan said he started the series after becoming an active listener of podcasts himself. He fell for the audio genre because it runs against the current of 30-second social media soundbytes, providing more thoughtful and detailed coverage of issues in a digestible format – that listeners can tune into while they are travelling or doing something else. But when he searched for something that “really covers global health, I did not find much” – especially not one that featured voices from low- and middle- income countries. So, he and his team decided to start their own series. “The ability to get a more insightful, in-depth understanding of a topic is why this medium is appealing. And for us at TDR, most importantly, this allows people from around the globe to learn from the experiences of others and apply them to their own reality,” said Aslanyan. Although WHO’s Regional Office for Europe offers a ‘Health in Europe’ podcast, and WHO headquarters features a popular Science in Five video series, Global Health Matters is the only broad-based and regular global health podcast featured by WHO, where TDR is based. Aslanyan has postgraduate training in public health and health policy and systems. While not a trained media professional, he was driven by a clear public health mission: to inspire his colleagues in the field. “You may not immediately think somebody trained in public health to host a podcast, but I have done all kinds of work for organizations focused on global health,” Aslanyan explained. “I also have experience in innovation and advocacy and have worked in government departments in Canada before moving to Geneva where I really pushed the boundaries of national health.” He said public health professionals need to be knowledgeable but also able to present things in a way that galvanizes the public around different causes. He had not thought of himself as that person before starting Global Health Matters, but since launch last year he hears from listeners that this is exactly the role he and his guests are fulfilling. “What makes me think that the podcast medium is amazing is the way that we reach cities, towns and villages in the most remote parts of the world, which is VERY satisfying – we know that from our stats,” Aslanyan says. What were some of the most popular episodes last year? “COVID-19 in Africa: the role of research” helped debunk some of the myths around why there was less virus on the continent. Global Health Matters Episode 3. An episode on “Climate change’s impact on health” looked at the impact of climate change on rural areas whose communities’ health and livelihood depends on the environment. A particular focus was on Maasai communities in northern Tanzania, where persistent droughts have made the people vulnerable to sleeping sickness, a disease spread by the tsetse fly. There was also a piece on Communicating science, not fiction featured Natalia Pasternak, founder of Brazilian-based Instituto Questão de Ciência, which combats pseudoscience and advocates for evidence-based treatments. Natalia spoke of her own personal experience as a member of WhatsApp groups for mothers that took a sudden turn into vaccine skepticism. And thousands of kilometers away, in the Western Pacific, Navigating digital health waves featuring Dr Alvin Marcelo, Executive Director of the Asia eHealth Information Network, explained how the Philippine government allowed open access to data from COVID-19 tests, creating a big opportunity for health researchers and services, for instance better matching of COVID-19 test results from particular locations with availability of hospital bed spaces. Natalia Pasternak, founder of Brazilian-based Instituto Questão de Ciência Dr Alvin Marcelo, Executive Director of the Asia eHealth Information Network. “Of course, we get feedback on every episode,” Aslanyan said. “It seems all of them have touched, inspired or at least piqued the interest of our listeners.” He said that he and his team at TDR stepped into podcasting with no experience but they have already learned a lot. Season 2 builds on last year’s, bringing in additional topics such as science diplomacy, corruption in health, migration and health and diversity in global health. Aslanyan said he also hopes to add an even greater variety of personalities to the podcasts, including, potentially, some guests who are public health service recipients rather than providers. He added that two universities in the global North and South are using some podcast episodes to assist students in understanding complex public health subjects – a testimony to the information and clarity being provided by the show. “We think it gives learners the ability to relate to the topics they are studying,” Aslanyan said. In terms of the spread and reach of his audience- it’s both surprising and satisfying, Aslanyan adds. “Sometimes I look at the analytics data showing the people listening to the podcast, and I think, my gosh, who are these eight people in that small city in Yemen who listened to me? I have no idea who they are, but they are there, in a place I don’t know, and I imagine they are probably working in public health.” The first episode of Season 2 launched on Tuesday April 12. Find it here. Link here to all Season 1 episodes of Global Health Matters. Find it on YouTube Championing Health Equity in South Africa Follow @TDRnews on Twitter, TDR on LinkedIn and @ghm_podcast on Instagram for updates about upcoming shows. Image Credits: WHO, GHM Show , GHM. Championing Health Equity in South Africa – Global Health Matters Podcast Series 13/04/2022 Editorial team The second season of the Global Health Matters podcast series kicks off with a close-up look at South Africa’s health equity initiatives and champions. Health Policy Watch will be featuring episodes from the series throughout the coming year as part of a TDR-supported series. As the world commits to equitable access to medicines and vaccines, is this just on paper or a reality? In the case of COVID-19, as of early April 2022, 74% of people in high-income countries had been fully vaccinated, compared with just 15% in Africa and 11% of people in low-income countries worldwide. With 30% of people fully vaccinated, South Africa, has one of the highest COVID vaccination rates in sub-Saharan Africa. And it has been an African leader in the manufacture of COVID vaccines, as well as a leader in the global campaign to waive intellectual property rights on COVID vaccines, tests and treatment – not to mention the historic role it played a generation ago in the legal battles that paved the way for the widespread manufacture of low-cost, generic antivirals for HIV treatment. Can South Africa’s experience with tackling HIV/AIDS and COVID-19 point to future solutions for other low- and middle-income countries? And how has the state of play regarding intellectual property rights for COVID health products affected development of vaccines across Africa? Global Health Matters podcast host Garry Aslanyan fields these and other questions to three leading South Africans scientists, policymakers and health activists, including Fatima Hassan (founder of the Health Justice Initiative), Petro Terblanche (Managing Director of Afrigen Biologics), and Judit Rius Sanjuan (Policy Specialist at UNDP). Click here to catch this episode, the first of the second season of TDR’s Global Health Matters podcast. Find it on YouTube: Championing Health Equity in South Africa Link here for all Season 1 episodes of Global Health Matters. Historic Public Hearings on WHO Pandemic Instrument; Some Unhappiness with Process 12/04/2022 Kerry Cullinan The last Ebola patient leaves a treatment centre in the Democratic Republic of Congo at the end of March 2021, marking the countdown to declaring the end of that pandemic. The World Health Organization (WHO) convened public hearings for only the second time in its history on Tuesday, asking interested parties what substantive issues should be contained in its proposed international instrument on pandemic preparedness and response. The first and only other WHO hearings were held 22 years ago in the run-up to the adoption of the Framework Convention on Tobacco Control, according to WHO principal legal officer Steven Solomon. Welcoming the public hearing, WHO Director-General Dr Tedros Adhanom Ghebreyesus said that informed opinion and active public cooperation are of the utmost importance to improve health, and it was important to learn from the COVID-19 pandemic to ensure the world is “better prepared” for the next pandemic. Tedros had been mandated by last year’s World Health Assembly Special Session to convene public hearings to inform the work of the Intergovernmental Negotiating Body (INB) which is in charge of negotiating the pandemic instrument or treaty. INB co-chair, South Africa’s Dr Precious Matsoso, described the hearings as “remarkable” and “historic”. Dr Precious Matsoso, INB co-chair Narrow responsibility However, the Civil Society Alliance for Human Rights in the Pandemic Treaty warned that the consultative process risks being “inadequate”. “While this week’s public hearings reflect the INB’s stated objective to consult the public to some extent, it has interpreted its responsibility to do so very narrowly,” according to the alliance. “The INB has allocated minimal time to engaging with the wide range of stakeholders who could inform the process and improve both the legitimacy and quality of the Treaty that emerges.” Dr Meg Davis, from the Global Health Centre at the Graduate Institute in Geneva, also said that participants had been given no indication of whether or how their submissions would be included in the negotiations and recommended policymaking models to ensure meaningful civil society engagement. A number of organisations gave two-minute speeches focusing on a wide range of issues including ‘One Health’, research and development (R&D) and intellectual property rights at the hearings, which continue on Wednesday and then reconvene in mid-June. Equity means sharing Research and Development Professor Suerie Moon, co-director of the Global Health Centre at the Graduate Institute in Geneva. All member states have committed to equity at the heart of any pandemic instrument, but Professor Suerie Moon, co-director of the Geneva Graduate Institute’s Global Health Centre, told the hearings that “equity requires collective research and development of vaccines, drugs and diagnostics”. Pointing out that COVID-19 has led to the development of technology transfer hubs in South Africa and the Republic of Korea, Moon warned that “there’s a risk that new factories will sit idle in the next emergency unless the new international instrument forges agreement on obligations to share knowledge, data and intellectual property before and during future emergencies”. “It’s unlikely, however, that countries or companies will do so out of the goodness of their hearts,” added Moon. “To make such sharing feasible, we have to tie it to commitments to jointly finance research and development to share pathogen samples and genomic sequencing data. In other words, the key idea is collective research and development for collective benefit.” Acknowledging that intellectual property was a difficult issue, Moon nonetheless said that if equitable access was to become a reality “the new instrument must include the nuts-and-bolts provisions to make sharing technology for pandemics the new normal”. To address IP, Knowledge Ecology International (KEI) recommended that governments should “agree to collectively use exceptions to intellectual property rights that are permitted in existing trade agreements and treaties”. “A model for this is the WIPO Marrakesh Treaty for the Blind, which mandates its members to use exceptions in copyrights to enhance global access to works made accessible to persons who are blind or have other disabilities,” according to KEI’s James Love. KEI also proposed “a robust chapter on transparency”, adding that “the lack of transparency in many areas for the current pandemic is an appalling and unnecessary policy failure, and one that both makes it more difficult to manage a pandemic response, and undermines the public’s trust in institutions”. Rachael Crockett from the Drugs for Neglected Diseases initiative (DNDi) stressed the need to co-ordinate R&D as a substantive element of the new instrument. DNDi wants R&D priority setting, and “globally agreed norms and binding rules that govern the R&D process, including transparency and open sharing of research, data, knowledge, technology, and equitable allocation of health tools”. Sharing pathogens IFPMA’s Grega Kumer Grega Kumer from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) said “any system should be built on what worked well during the COVID pandemic, in particular, immediate sharing of pathogens and a robust response from the IP based private sector”. The IFPMA presented eight core principles, including that the negotiation process should be “inclusive and transparent, involving the private sector and all critical contributors to pandemic preparedness efforts”. “Any system should allow for immediate access of pathogens and genetic sequence data and correct the negative effects of access and benefit-sharing legislation,” said Kumer. The IFPMA also supports more equitable access to tests, treatments and vaccines “based on medical need, thus enhancing solidarity and facilitating emergency financing to institutions procuring for developing countries”, and the protection of supply chains ”from arbitrary export restrictions and other trade barriers”. “While the public sector might play a larger role in pandemic setting, the system should build on the private sector strengths for R&D, manufacturing and distribution,” he concluded. One Health is key The need for any pandemic instrument to adopt a One Health approach also emerged as a key theme. Dame Sally Davies, speaking for the UN Global Leaders Group on Antimicrobial Resistance (AMR), said that they wanted AMR to be integrated alongside a primary focus on pandemics. “The next pandemic could be drug-resistant, or could depend on antimicrobials to mitigate it,” said Davies, saying that one health surveillance needed to be at the heart of any pandemic treaty to enable “rapid, transparent and responsive protection”. Governance principles The Panel for a Global Health Convention believes the instrument must be governed by four non-negotiable principles, according to Dame Barbara Stocking. “Solidarity, because we’re all in this together, and solidarity is in our own self-interest,” explained Stocking. “Equity: there must be equal access to vaccines and treatments, but also an equal voice in decision-making. Transparency in reporting data and samples. Accountability, as the lack of accountability of countries is the fundamental reason that we are in disarray.” The hearings continue at 8am CET on Wednesday and can be followed live. Image Credits: WHO African Region. Nineteen More Attacks on Ukraine’s Health Facilities Since Friday: WHO 11/04/2022 Kerry Cullinan Ukraine operating theatre destroyed The World Health Organization (WHO) has verified 108 attacks on health care in Ukraine as of Monday in which 73 people have died and 51 have been injured. That is 19 more attacks on health facilities than the already deadly toll of 91 attacks that had been verified by WHO as of early Friday afternoon, and as reported at a press conference by WHO’s Regional Director Hans Kluge in Lviv. .@WHO has verified 5 additional reports of attacks on health care in #Ukraine. As of 11 April, 108 attacks on health care in Ukraine have been verified, causing 73 deaths and 51 injuries. We are outraged that attacks on health care are continuing. pic.twitter.com/8GNUQZFiK9 — WHO Ukraine (@WHOUkraine) April 11, 2022 Meanwhile, the Office of the UN High Commissioner for Human Rights (OHCHR) has recorded 1,793 civilian deaths and 2,439 injuries since the start of the Russian invasion on 24 February and Sunday. Most of the civilian casualties have been caused by “explosive weapons with a wide impact area”, including shelling from heavy artillery and rocket, missile and air strikes. https://data.humdata.org/visualization/ukraine-humanitarian-operations/ “OHCHR believes that the actual figures are considerably higher, as the receipt of information from some locations where intense hostilities have been going on has been delayed and many reports are still pending corroboration,” according to a statement from the office. “This concerns, for example, Mariupol (Donetsk region), Izium (Kharkiv region), Popasna (Luhansk region), and Borodianka (Kyiv region), where there are allegations of numerous civilian casualties. These figures are being further corroborated and are not included in the above statistics.” According to the Prosecutor General’s Office of Ukraine, 176 children had been killed and at least 336 injured as of Sunday. Image Credits: WHO. Pfizer Refuses Cooperation with DNDi on Study of Paxlovid Treatment Adapted to Low Income Countries 08/04/2022 Elaine Ruth Fletcher & Kerry Cullinan Paxlovid Pfizer has so far refused an invitation from the Geneva-based Drugs for Neglected Diseases Initiative (DNDi) to cooperate on a study exploring whether the treatment window of its successful antiviral drug, Paxlovid, could be extended from 5-7 days using another drug compound in addition, Dr Nathalie Strub-Wourgaft, Director of DNDi’s COVID-19 Response, told Health Policy Watch. DNDi wants to test if the key active ingredient of Paxlovid, nirmatrelvir, could be offered in combination with an inhaled corticosteroid, budesonide, in order to extend the treatment window of the life-saving COVID treatment by two more days, Strub-Wourgaft said in an interview. Extending the treatment window is critical for patients in low-income countries because the currently-approved formulation of Paxlovid must be commenced within 3-5 days of COVID symptoms. Meanwhile ANTICOV, a major DNDi-sponsored trial of COVID treatments underway in ten African countries, has revealed that one-half of COVID patients present for treatment after the five day cut-off date. ANTICOV clinical trial. That makes the current Paxlovid combination less than suitable for low- and middle-income country (LMIC) conditions, said Strub-Wourgaft. She is one of the coordinators of the ANTICOV Consortium, a group of 26 African and global research organizations engaged in the clinical trial research on novel COVID drugs for LMICs. On 15 March, DNDi issued a public statement expressing its concern that “efforts to conduct urgently needed studies in low- and middle-income countries (LMICs) utilizing the novel oral antiviral, nirmatrelvir/ritonavir (Paxlovid), are being blocked by Pfizer, which developed the drug. Paxlovid, which uses the common HIV drug ritonavir in combination with nirmatrelvir, has been found to reduce the risk of hospitalization or death by a stunning 89% in patients at high risk of severe COVID-19 disease. But the treatment needs to be taken within three to five days of patients developing symptoms. According to DNDi, “an interim analysis done in the context of the ongoing ANTICOV clinical trial conducted in 10 African countries showed that of the 1180 patients enrolled, more than half present for care after day 5. “To overcome this challenge, it is necessary to explore whether using Paxlovid with other drugs could widen the ‘treatment window’ to at least seven days,” DNDi said in its statement. DNDi also wants to investigate if the drug could be “beneficial for immune-suppressed patients who are the most vulnerable to disease progression but were excluded from phase 3 trials.” DNDi, a Geneva-based not-for-profit research and development organisation, works to deliver new treatments on neglected diseases and serving neglected groups in low- and middle-income countries. Still looking for ways to access nirmatrelvir DNDi drug development. Strub, in her comments to Health Policy Watch, suggested that DNDi, which has a good track record of building cooperation with the pharma industry, was still trying to obtain the drug somehow – or even persuade Pfizer to collaborate. “We would like to test nirmatrelvir/ritonavir in combination, as well, with inhaled budesonide or maybe fluoxetine (brand name Prozac),” said Strub-Wourgaft. “We issued a statement to say that we had asked Pfizer to get access to nirmatrelvir, to work with us on this trial. They denied. We’re continuing to try to get access to this drug.” “We think this [combination] would extend the window of treatment to seven days of symptoms. In the study that they [Pfizer] have done, which is a great study showing really fantastic results, they looked at patients who had five days of symptoms before they were enrolled. “And we have seen for now, in our study in Africa, that half of the patients come after five days of symptoms,” she said. Such delays are typical because COVID diagnosis and treatment services are less widely available and it thus takes people longer to get diagnosed, even if they are symptomatically ill. “There are critically important public health research questions that must be answered quickly – particularly in low- and middle-income countries where access to vaccines remains low,” added Strub-Wourgaft, in the DNDi statement. “It is difficult to understand any rationale for refusing to cooperate in the midst of a global pandemic, and this sets a dangerous precedent since there are many other promising antivirals in the pipeline and these novel treatments will also require follow-on research to determine their optimal use in resource-limited settings.” MPP deal with Pfizer – not enough Pfizer recently signed a deal with another Geneva-based group, the non-profit Medicines Patent Pool, that will allow 35 new manufacturers to produce and supply generic versions of Paxlovid to some 95 low- and middle income countries – in what the company has said is a move to lower the drug’s cost and expand access in low-income countries. But that deal has also been criticised for failing to cover dozens of other middle-income and upper-middle income countries that will have to purchase patented versions of the drug. Although Pfizer had also said that it would create a tiered pricing system for Paxlovid, drug price advocates say that the price remains too high in many settings. In the United States, the government pays Pfizer about $530 for a five day course, although the pills also are in short supply in some US communities. In addition, most of Pfizer’s Paxlovid supply for the first half of 2022 has already been bought up by rich countries, meaning that LMICs will only be able to get about 10 million doses of the drug in the near term. Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates However, even considering the MPP deal and other preferential pricing mechanisms, the fact remains that the version of Paxlovid currently being produced is not an optimal fit for many LMICs, Strub-Wourgaft said. “So for now, if we were to be able to give them Paxlovid, under the current conditions, half of them would not even have access,” she told Health Policy Watch. MPP deals with generic manufacturers may not enable supplies to ANTICOV DNDi is also concerned about the potential difficulty of obtaining generic versions of Paxlovid to conduct the new ANTICOV combination studies, the company has said. “The terms of the Pfizer/Medicines Patent Pool (MPP) licensing agreement to the new generics manufacturers could be interpreted to mean that sub-licensees cannot provide nirmatrelvir/ritonavir for use in the sorts of combination studies that DNDi and others wish to conduct, unless they have explicit written approval from Pfizer. “Some generic manufacturers are also encountering difficulties obtaining Paxlovid as a ‘reference drug’ so that they can conduct the necessary bioequivalence studies to show regulators that their generic version has the same effect in the body, effectively blocking availability of generics for both research and clinical use”, DNDi added in its statement. It has therefore asked Pfizer to not only provide access to nirmatrelvir/ritonavir (Paxlovid) for the DNDi-coordinated ANTICOV trial and other relevant clinical trials, but also to: Remove any ambiguities or restrictions in the Pfizer-MPP licensing agreement that could prevent sub-licensees from supplying such research studies (or publicly clarify that no such restrictions exist); Provide access to Pfizer’s originator product as a ‘reference drug’ so that any interested generic manufacturer can conduct the necessary bioequivalence studies for regulatory approval; and Allocate sufficient quantities of Paxlovid specifically for LMICs and remove all barriers to access to generic nirmatrelvir/ritonavir to enable scale up for care and treatment in LMICs. “Every effort should be made to ensure that clinical studies for COVID-19 treatment are conducted in low- and middle-income countries, and that any products developed reach vulnerable populations,” said Dr John Amuasi, head of the Global Health and Infectious Diseases Research Grou at Kumasi Center for Collaborative Research in Tropical Medicine in Ghana and a principal investigator for ANTICOV. “We must not arrive at a situation where research priorities are determined by the actions or inactions of any company.” Pfizer response – committed to well-controlled trials In response to a request from Health Policy Watch, a Pfizer spokesperson did not provide any clarification of the reasons behind the company’s refusal to participate in the DNDi trial – aimed a making the treatment more suitable to low-income settings. “Pfizer appreciates the importance of gathering additional data and information for governments to help maximize the public health response to the COVID-19 pandemic,” said the spokesperson, adding that the company is committed to “well-controlled, hypothesis-driven clinical studies that can provide data that will be accepted by global regulatory agencies. “Additional studies of PAXLOVID are underway or are being explored, and we will continue to share information as we have it,” the spokesperson added. In addition, “Right now, we are focusing our efforts and resources in a way that maximizes availability of our overall supply, to help ensure access to patients as quickly as possible,” the spokesperson said, noting that the company remains “confident” in the clinical trial results, which showed an 88-89% efficacy rate for the drug, when it was administered to non-hospitalized, high-risk patients within 3-5 days of symptom onset. -Updated 9 April with correction on the price of Paxlovid paid by the US government for patients in the USA and on 11 April with details of Pfizer response. Image Credits: Bobbi-Jean MacKinnon, DNDI/Twitter, DNDi. Artificial Intelligence ‘Boot Camp’ Aims to Accelerate Drug Discovery 08/04/2022 Maayan Hoffman Machine learning is playing an increasingly important role in computing and artificial intelligence. TEL AVIV – Ninety percent of drug candidates fail in clinical trials because of unexpected safety issues or lack of efficacy in human subjects, according to Noga Yerushalmi, Investment Director at M Ventures, the strategic, corporate venture capital arm of Merck. There have been dramatic improvements in omics technologies – that is the collective technologies used to explore molecular behaviour, such as genomics, proteomics, metabolomics, metagenomics and transcriptomics. And this is enabling scientists to analyze potential drug targets more efficiently in terms of their potential impact on a pathogen or disease. But there is no automated solution that harnesses all preclinical data in a way that allows for a reliable assessment of the clinical trial readiness of a new drug candidate. Now, some pharma and research initiatives are hoping to change that, among them AION Labs. Together with its German partner BioMed X, the Israeli-based research alliance, hosted 15 teams of computational biologists, AI researchers and biomedical scientists for a ‘boot camp’ that aims to speed up the drug discovery process and lower costs – harnessing AI technologies in novel ways. Mission: identify critical safety issues before expensive clinical trial stage The latest boot camp cohort The teams were charged with making a proposal for the development of a versatile, next-generation computational platform that can identify hidden safety liability and lack of efficacy, and close identified gaps in the drug candidate pre-clinical data package. “The big problem in drug discovery and development is that after a lot of experiments have been done and we have a new drug candidate, many of these candidates fail in very expensive clinical trials in humans,” Dr. Christian Tidona, founder and managing director of the BioMed X Institute told Health Policy Watch. “That’s because humans are different from mice or a dish in the lab.” The challenge is that pharma companies usually only discover that a drug candidate either is not safe or will not work after years of effort and hundreds of millions of dollars of investment. Companies can invest $5 billion and 12-years’ time, on average, Tidona said, to create the next “blockbuster drug.” “When one thinks about these numbers, he can imagine why some of these drugs are so expensive. Could an AI platform predict if a drug is really ready for the clinic and, if not, tell us what was missed before we go to trial?” Tidona asked. “This is the question. “If drugs can be made more efficiently, medicines can become cheaper and more people in all parts of the world could afford them,” he said. Solving therapeutic challenges Kahina Lang, head of Strategic Innovation at Merck Group, addresses the candidates at the AION Labs boot camp. Based in Rehovot, not far from the the famed Weizmann Institute, AION brings together some of the biggest names in pharma, including AstraZeneca, Merck, Pfizer, and Teva, with young biotech inventors and entrepreneurs, to crack biomedical research challenges together and in a novel way. “We work with each of our pharma partners separately and then together to identify the top research challenges that solving would be majorly impactful for the industry at large,” AION CEO Mati Gill told Health Policy Watch. Then, AION looks for innovators and scientists to develop solutions for them. For last week’s boot camp, 15 applicants from around the world were selected to come to Israel and participate. “The winner receives a $2 million investment, mentorship and access to a wealth of data for model training from these four big pharma companies,” Tidona said. “It is more or less paradise for anyone who wants to start a company.” The concept is based on a model Tidona first developed on the campus of the University of Heidelberg in Germany, with a world-wide network of partner locations. If the company succeeds, the technology belongs to it but will be made available for purchase by the pharma partners. ‘Bringing the promise of AI to fruition’ Guy Spigelman of AWS addresses candidates at the AION Labs bootcamp. Merck’s Yerushalmi said that there have been “all kinds of efforts to make the drug development model more efficient – to expedite it,” but until now it has not worked. When computational approaches to research were first introduced, “it brought a lot of promise, but until now it has not brought as much fruit as we hoped. Now, with AI tools and the amount of data pharma and other companies can generate, we do hope we may be able to bring this promise to fruition.” AI is one of the most sophisticated computational tools. AI analysis has brought “ingenious” solutions to other fields, like the automotive industry, she pointed out. “AI tools and big data have proven themselves in so many other cases, I think it will probably work for our industry too,” Yerushalmi said. “Want to make [drug development] more affordable and shorter, so we can bring drugs to the market faster and cheaper for the benefit of humanity.” Finding the most effective antibodies AION will be looking for the next therapeutic antibodies. This most recent boot camp was AION’s second one so far. Earlier this year, it invited computational biologists and biomedical scientists to propose ideas for discovering therapeutic antibodies. “Advances in protein structure prediction, artificial intelligence algorithms, and increased availability of experimentally determined antigen-antibody structures present a unique opportunity for AI-driven antibody discovery,” AION said in a release. In the coming months, it will hold a third boot camp at which computational biologists, bioinformatics and cheminformatics scientists and AI researchers will propose ideas for the development of a next-generation computational platform to optimize antibodies for targeted therapies with enhanced properties, including developability or manufacturability, stability, aggregation, immunogenicity, pharmacokinetics and tissue distribution. “The ultimate solution is an AI platform that receives sequences of binders and generates novel variants with optimized IgG sequences, biophysical and targeting properties,” a background briefing explained. “The goal of the AI algorithm is to make an existing antibody a better drug while reducing design iterations, optimization of cycle times and lowering attrition rates.” CEPI launches AI-based quest for beta-coronavirus vaccine candidate The AION initiative, while pioneering in the use of AI for drug discovery, is not the only one. On Thursday, the Oslo-based Coalition for Epidemic Preparedness (CEPI) announced that it would provide seed funding of up to US $4.8 million to a consortium to support the AI-based development of betacoronavirus vaccine candidates – the new holy grail for coronavirus vaccines. The research consortium, led by a Norway-based subsidiary of the Japanese NEC Group, which specializes in AI technologies, also includes the European Vaccine Initiative (EVI) and Oslo University Hospital. It aims to establish preclinical proof of concept for an mRNA-based vaccine that protects against a broad range of beta coronaviruses – rather than SARS-CoV2 alone, said CEPI in a press release. NEC will apply its experience in the AI design of immunogens to identify novel vaccine antigens with broad reactivity against beta-coronaviruses. The lead antigens will be selected iteratively and validated in preclinical studies against known beta coronaviruses that already pose a significant epidemic or pandemic risk, such as SARS-CoV, SARS-CoV-2 and MERS-CoV. If the approach is successful, it may also be applicable for developing vaccines against other pathogens in the CEPI portfolio, including ‘Disease X’ – unknown pathogens with pandemic potential that have yet to emerge. What the future holds What the future of AI holds. Tidona, for his part, hopes that AION will spin off 20 new start-ups in the next four to six years. “We are building an innovation ecosystem,” he said, noting that it is attractive to host countries as it provides a draw for youthful talent, which in turn spurs economic development. He added that if the model works well, BioMed X plans to export it to other countries as well. “The focus now is on Israel as our first partner outside Germany,” Tidona said. “But in the future, we hope to have sites” in other places, too. Image Credits: https://www.flickr.com/photos/mikemacmarketing/42271822770/, AION Labs, Elad Malka, Twitter: @WHO, https://www.flickr.com/photos/158301585@N08/43267970922/. Global Health Leaders Call on African Policymakers To Do More to Stop Climate Change 08/04/2022 Paul Adepoju WHO argues that climate-smart initiatives are good for health. But the health sector receives less than 1% of international climate finance, said Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC). Global health leaders have repeatedly called for stepped up investments to both slow down climate change and recognize the health co-benefits of more climate action. But political leaders, including those in low and middle-income countries, still need to do more, Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC) told Health Policy Watch in a briefing on Thursday, World Health Day. Meanwhile, WHO’s Regional Director for Africa, Matshidiso Moeti, enjoined African governments to “prioritize human wellbeing in every strategy and decision,” including halting fossil fuel expansion that ultimately will boomerang on the countries concerned. “I’d like to take this opportunity to call on an African governments to prioritize human wellbeing in every strategy and decision to halt new fossil fuel exploration and subsidies, institute taxes for polluting firms and to implement the WHO air quality guidelines for example,” said Moeti, speaking on this year’s World Health Day theme, ‘Our Planet, Our Health.’ Added Cissé, countries that harness more of their own national and local policies, innovations and resources can make a difference. “Countries can go for some financial incentive policy at a national scale that includes taxes and subsidies; they can also have some innovative policies regarding insurance. They can also give some small scale financial products to low income and other households,” Cissé said. Support to health sector less than 1% of international climate finance Experts are increasingly aware of the multi-faced impacts of the climate crisis on health – as well and the increased precarity of health in the face of deforestation and biodiversity loss as well as unhealthy foods production – which are also driving climate change. So far, however, support to the health sector for climate action still comprises less than 1% of international climate finance investments, Cissé said, speaking at a WHO African Region World Health Day briefing. Health co-benefits of climate mitigation strategies – for instance fewer air pollution-related deaths from cleaner energy investments, also go uncounted in climate strategies. This, despite health being mentioned as a priority in 54% of countries’ Nationally Determined Contributions (NDCs), which are the main instruments now being used for global climate pledges to reduce harmful emissions, under the UN Framework Convention on Climate Change. Cissé who works with the Swiss Tropical and Public Health Institute at the University of Basel in Switzerland, noted that this reflects the low priority still being given to climate change in the context of health. World Health Day at a time of heightened conflict and fragility Joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra (center) and WHO Director-General Dr Tedros Adhanom Ghebreyesus (right) This year’s World Health Day, which marks the April 7, 1948 date of WHO’s founding, comes at a time of both heightened political conflict and greater ecosystem fragility, noted WHO Director-General Dr Tedros Adhanom Ghebreyesus. He was speaking at a joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra. “The pandemic has highlighted the intimate links between the health of humans, animals and the environment. And yet, we’re rapidly making the planet on which all life depends and inhabitable… “The climate crisis is a health crisis,” Tedros said at the Thursday briefing, which concluded a series of face-to-face meetings this week with US Administration officials – the first since President Joe Biden’s inauguration last year. ”Air pollution kills 7 million people every year. And 99% of the world’s population breathes unhealthy air mainly as a result of burning fossil fuels,” Tedros added. (see related story) “Our warming world is facilitating the spread of mosquitoes and diseases they carry. Extreme weather events, biodiversity loss, land degradation, and water scarcity are displacing people and damaging their health,” Tedros said. “Systems that produce highly processed, unhealthy foods are driving a wave of obesity, increasing cancer and heart disease, and generating one-third of greenhouse gas emissions. “As the world recovers from the pandemic we have a choice: we can go back to the way things were or we can change course. We can create societies, economies and products that nurture health and well being, and stop subsidizing those that destroy – because we cannot afford to pump carbon into the atmosphere at the same rate, and still breathe clean air. “We cannot afford the same patterns of consumption and expect less diabetes, hypertension, heart disease and cancer. We must choose. We cannot afford ever-deepening inequalities and expect continued prosperity. We must choose.” Half new fossil fuel exploration and subsidies, prioritize health, says WHO Regional Director Water shortage in Ethiopia. Population exposure to heat is increasing due to climate change. Globally, extreme temperature events are observed to be increasing in their frequency, duration, and magnitude. In Africa, one of the regions of the world that is worst affected by climate change, extreme weather events are having ever greater impacts on food security, water access, and related to that, nutrition and disease transmission. Of the more than 2000 public health events recorded in the African region between 2019 and 2020, more than half were climate-related, said Moeti, speaking from WHO’s Regional Office in Brazzaville. This, she said, represented a 25% increase compared with the previous decade. “In Africa, diarrhoeal diseases are the third leading cause of death and illness in children younger than five, which could be preventable with safe drinking water, adequate sanitation and hygiene, and installation,” Moeti said. “Our analysis showed that waterborne diseases, mainly due to cholera outbreaks, accounted for 40% of climate-related health emergencies in the past 20 years.” In urging African governments to adopt cleaner, healthier policies, she said the main motive is really self-preservation. “Älthough Africa contributes the least to global warming, the continent bears a disproportionate burden of the consequences,” said Moeti. “It’s up to every one of us to promote and support multi-sectoral interventions that address the threat of climate change, while helping to better prepare for future health shocks like the COVID-19 pandemic.” Image Credits: Oxfam East Africa. 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.
Global Health Matters: Around the World of Public Health in Audio 13/04/2022 Maayan Hoffman Global Health Matters podcast host Dr. Garry Aslanyan, TDR After Dr Garry Aslanyan became an avid follower of podcasts, he realized there was a dearth of material from the genre in his own global health field. So he set out to fill that gap with a new series featuring public health professionals and policymakers from around the world who have made a difference – and can inspire others as well. The Global Health Matters podcast hosted by Aslanyan, a public health professional with TDR, the Special Programme for Research and Training in Tropical Diseases, co-sponsored by UNICEF, UNDP, the World Bank and WHO, is now entering its second season of broadcasts. It features a diverse mix of themes and line-up of speakers – has picked up an audience of followers in places as diverse as Yemeni villages and Ulaanbaatar, Mongolia. The first episode of Season 2 was launched on Tuesday, April 12. It focuses on “Championing Health Equity in South Africa.” “The podcast gives people a unique peek into the experiences of people who are just like them,” Aslanyan told Health Policy Watch. “Listeners can relate to the guests and their experiences and compare what they themselves are living through – they can think, ‘can I do this?’ or ‘how does that work?’ or ‘what can this mean for me in my own setting or country?’” The podcast began at the height of the COVID-19 pandemic, when new, virtual information tools became all the more important to people confined for days and weeks at home. The podcast series has already covered a broad range of innovative and inspiring research topics – from climate change and health to science communication and the challenge of ‘decolonizing global health.’ With a focus on sharing perspectives and voices from low- and middle-income countries, the series has already been downloaded more than 11,000 times by listeners in more than 130 countries, Aslanyan said. “The hope is to inspire listeners to do something in their day job with the information they heard,” Aslanyan said. South Africa at the nexus of the global health equity debate This week’s episode on “Championing health equity in South Africa” takes a long look at the country’s COVID vaccine campaign, whose successes and setbacks were a weathervane for the rest of Africa, as well as its precedent-setting examples in advocating for HIV medicines access, in light of the recent pandemic. “As of early March, 74% of those in high-income countries have been fully vaccinated against COVID-19, compared with just 11% of people in low-income countries. As the world commits to global access to medicines and vaccines, is this just on paper or a reality?” the podcast teaser states. “Can South Africa’s experience with tackling HIV/AIDS and COVID-19 point to future solutions for other low- and middle-income countries? How has intellectual property rights affected development of vaccines across Africa?” Appearing on the podcast are three guests: human rights lawyer and activist Fatima Hassan; UNDP policy specialist Judit Rius Sanjuan; and Petro Terblanche, Managing Director of Afrigen Biologics, host of the new mRNA hub in South Africa. Season 2 of Global Health Matters launched this week: Championing Health Equity in South Africa. The goal: To inspire Aslanyan said he started the series after becoming an active listener of podcasts himself. He fell for the audio genre because it runs against the current of 30-second social media soundbytes, providing more thoughtful and detailed coverage of issues in a digestible format – that listeners can tune into while they are travelling or doing something else. But when he searched for something that “really covers global health, I did not find much” – especially not one that featured voices from low- and middle- income countries. So, he and his team decided to start their own series. “The ability to get a more insightful, in-depth understanding of a topic is why this medium is appealing. And for us at TDR, most importantly, this allows people from around the globe to learn from the experiences of others and apply them to their own reality,” said Aslanyan. Although WHO’s Regional Office for Europe offers a ‘Health in Europe’ podcast, and WHO headquarters features a popular Science in Five video series, Global Health Matters is the only broad-based and regular global health podcast featured by WHO, where TDR is based. Aslanyan has postgraduate training in public health and health policy and systems. While not a trained media professional, he was driven by a clear public health mission: to inspire his colleagues in the field. “You may not immediately think somebody trained in public health to host a podcast, but I have done all kinds of work for organizations focused on global health,” Aslanyan explained. “I also have experience in innovation and advocacy and have worked in government departments in Canada before moving to Geneva where I really pushed the boundaries of national health.” He said public health professionals need to be knowledgeable but also able to present things in a way that galvanizes the public around different causes. He had not thought of himself as that person before starting Global Health Matters, but since launch last year he hears from listeners that this is exactly the role he and his guests are fulfilling. “What makes me think that the podcast medium is amazing is the way that we reach cities, towns and villages in the most remote parts of the world, which is VERY satisfying – we know that from our stats,” Aslanyan says. What were some of the most popular episodes last year? “COVID-19 in Africa: the role of research” helped debunk some of the myths around why there was less virus on the continent. Global Health Matters Episode 3. An episode on “Climate change’s impact on health” looked at the impact of climate change on rural areas whose communities’ health and livelihood depends on the environment. A particular focus was on Maasai communities in northern Tanzania, where persistent droughts have made the people vulnerable to sleeping sickness, a disease spread by the tsetse fly. There was also a piece on Communicating science, not fiction featured Natalia Pasternak, founder of Brazilian-based Instituto Questão de Ciência, which combats pseudoscience and advocates for evidence-based treatments. Natalia spoke of her own personal experience as a member of WhatsApp groups for mothers that took a sudden turn into vaccine skepticism. And thousands of kilometers away, in the Western Pacific, Navigating digital health waves featuring Dr Alvin Marcelo, Executive Director of the Asia eHealth Information Network, explained how the Philippine government allowed open access to data from COVID-19 tests, creating a big opportunity for health researchers and services, for instance better matching of COVID-19 test results from particular locations with availability of hospital bed spaces. Natalia Pasternak, founder of Brazilian-based Instituto Questão de Ciência Dr Alvin Marcelo, Executive Director of the Asia eHealth Information Network. “Of course, we get feedback on every episode,” Aslanyan said. “It seems all of them have touched, inspired or at least piqued the interest of our listeners.” He said that he and his team at TDR stepped into podcasting with no experience but they have already learned a lot. Season 2 builds on last year’s, bringing in additional topics such as science diplomacy, corruption in health, migration and health and diversity in global health. Aslanyan said he also hopes to add an even greater variety of personalities to the podcasts, including, potentially, some guests who are public health service recipients rather than providers. He added that two universities in the global North and South are using some podcast episodes to assist students in understanding complex public health subjects – a testimony to the information and clarity being provided by the show. “We think it gives learners the ability to relate to the topics they are studying,” Aslanyan said. In terms of the spread and reach of his audience- it’s both surprising and satisfying, Aslanyan adds. “Sometimes I look at the analytics data showing the people listening to the podcast, and I think, my gosh, who are these eight people in that small city in Yemen who listened to me? I have no idea who they are, but they are there, in a place I don’t know, and I imagine they are probably working in public health.” The first episode of Season 2 launched on Tuesday April 12. Find it here. Link here to all Season 1 episodes of Global Health Matters. Find it on YouTube Championing Health Equity in South Africa Follow @TDRnews on Twitter, TDR on LinkedIn and @ghm_podcast on Instagram for updates about upcoming shows. Image Credits: WHO, GHM Show , GHM. Championing Health Equity in South Africa – Global Health Matters Podcast Series 13/04/2022 Editorial team The second season of the Global Health Matters podcast series kicks off with a close-up look at South Africa’s health equity initiatives and champions. Health Policy Watch will be featuring episodes from the series throughout the coming year as part of a TDR-supported series. As the world commits to equitable access to medicines and vaccines, is this just on paper or a reality? In the case of COVID-19, as of early April 2022, 74% of people in high-income countries had been fully vaccinated, compared with just 15% in Africa and 11% of people in low-income countries worldwide. With 30% of people fully vaccinated, South Africa, has one of the highest COVID vaccination rates in sub-Saharan Africa. And it has been an African leader in the manufacture of COVID vaccines, as well as a leader in the global campaign to waive intellectual property rights on COVID vaccines, tests and treatment – not to mention the historic role it played a generation ago in the legal battles that paved the way for the widespread manufacture of low-cost, generic antivirals for HIV treatment. Can South Africa’s experience with tackling HIV/AIDS and COVID-19 point to future solutions for other low- and middle-income countries? And how has the state of play regarding intellectual property rights for COVID health products affected development of vaccines across Africa? Global Health Matters podcast host Garry Aslanyan fields these and other questions to three leading South Africans scientists, policymakers and health activists, including Fatima Hassan (founder of the Health Justice Initiative), Petro Terblanche (Managing Director of Afrigen Biologics), and Judit Rius Sanjuan (Policy Specialist at UNDP). Click here to catch this episode, the first of the second season of TDR’s Global Health Matters podcast. Find it on YouTube: Championing Health Equity in South Africa Link here for all Season 1 episodes of Global Health Matters. Historic Public Hearings on WHO Pandemic Instrument; Some Unhappiness with Process 12/04/2022 Kerry Cullinan The last Ebola patient leaves a treatment centre in the Democratic Republic of Congo at the end of March 2021, marking the countdown to declaring the end of that pandemic. The World Health Organization (WHO) convened public hearings for only the second time in its history on Tuesday, asking interested parties what substantive issues should be contained in its proposed international instrument on pandemic preparedness and response. The first and only other WHO hearings were held 22 years ago in the run-up to the adoption of the Framework Convention on Tobacco Control, according to WHO principal legal officer Steven Solomon. Welcoming the public hearing, WHO Director-General Dr Tedros Adhanom Ghebreyesus said that informed opinion and active public cooperation are of the utmost importance to improve health, and it was important to learn from the COVID-19 pandemic to ensure the world is “better prepared” for the next pandemic. Tedros had been mandated by last year’s World Health Assembly Special Session to convene public hearings to inform the work of the Intergovernmental Negotiating Body (INB) which is in charge of negotiating the pandemic instrument or treaty. INB co-chair, South Africa’s Dr Precious Matsoso, described the hearings as “remarkable” and “historic”. Dr Precious Matsoso, INB co-chair Narrow responsibility However, the Civil Society Alliance for Human Rights in the Pandemic Treaty warned that the consultative process risks being “inadequate”. “While this week’s public hearings reflect the INB’s stated objective to consult the public to some extent, it has interpreted its responsibility to do so very narrowly,” according to the alliance. “The INB has allocated minimal time to engaging with the wide range of stakeholders who could inform the process and improve both the legitimacy and quality of the Treaty that emerges.” Dr Meg Davis, from the Global Health Centre at the Graduate Institute in Geneva, also said that participants had been given no indication of whether or how their submissions would be included in the negotiations and recommended policymaking models to ensure meaningful civil society engagement. A number of organisations gave two-minute speeches focusing on a wide range of issues including ‘One Health’, research and development (R&D) and intellectual property rights at the hearings, which continue on Wednesday and then reconvene in mid-June. Equity means sharing Research and Development Professor Suerie Moon, co-director of the Global Health Centre at the Graduate Institute in Geneva. All member states have committed to equity at the heart of any pandemic instrument, but Professor Suerie Moon, co-director of the Geneva Graduate Institute’s Global Health Centre, told the hearings that “equity requires collective research and development of vaccines, drugs and diagnostics”. Pointing out that COVID-19 has led to the development of technology transfer hubs in South Africa and the Republic of Korea, Moon warned that “there’s a risk that new factories will sit idle in the next emergency unless the new international instrument forges agreement on obligations to share knowledge, data and intellectual property before and during future emergencies”. “It’s unlikely, however, that countries or companies will do so out of the goodness of their hearts,” added Moon. “To make such sharing feasible, we have to tie it to commitments to jointly finance research and development to share pathogen samples and genomic sequencing data. In other words, the key idea is collective research and development for collective benefit.” Acknowledging that intellectual property was a difficult issue, Moon nonetheless said that if equitable access was to become a reality “the new instrument must include the nuts-and-bolts provisions to make sharing technology for pandemics the new normal”. To address IP, Knowledge Ecology International (KEI) recommended that governments should “agree to collectively use exceptions to intellectual property rights that are permitted in existing trade agreements and treaties”. “A model for this is the WIPO Marrakesh Treaty for the Blind, which mandates its members to use exceptions in copyrights to enhance global access to works made accessible to persons who are blind or have other disabilities,” according to KEI’s James Love. KEI also proposed “a robust chapter on transparency”, adding that “the lack of transparency in many areas for the current pandemic is an appalling and unnecessary policy failure, and one that both makes it more difficult to manage a pandemic response, and undermines the public’s trust in institutions”. Rachael Crockett from the Drugs for Neglected Diseases initiative (DNDi) stressed the need to co-ordinate R&D as a substantive element of the new instrument. DNDi wants R&D priority setting, and “globally agreed norms and binding rules that govern the R&D process, including transparency and open sharing of research, data, knowledge, technology, and equitable allocation of health tools”. Sharing pathogens IFPMA’s Grega Kumer Grega Kumer from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) said “any system should be built on what worked well during the COVID pandemic, in particular, immediate sharing of pathogens and a robust response from the IP based private sector”. The IFPMA presented eight core principles, including that the negotiation process should be “inclusive and transparent, involving the private sector and all critical contributors to pandemic preparedness efforts”. “Any system should allow for immediate access of pathogens and genetic sequence data and correct the negative effects of access and benefit-sharing legislation,” said Kumer. The IFPMA also supports more equitable access to tests, treatments and vaccines “based on medical need, thus enhancing solidarity and facilitating emergency financing to institutions procuring for developing countries”, and the protection of supply chains ”from arbitrary export restrictions and other trade barriers”. “While the public sector might play a larger role in pandemic setting, the system should build on the private sector strengths for R&D, manufacturing and distribution,” he concluded. One Health is key The need for any pandemic instrument to adopt a One Health approach also emerged as a key theme. Dame Sally Davies, speaking for the UN Global Leaders Group on Antimicrobial Resistance (AMR), said that they wanted AMR to be integrated alongside a primary focus on pandemics. “The next pandemic could be drug-resistant, or could depend on antimicrobials to mitigate it,” said Davies, saying that one health surveillance needed to be at the heart of any pandemic treaty to enable “rapid, transparent and responsive protection”. Governance principles The Panel for a Global Health Convention believes the instrument must be governed by four non-negotiable principles, according to Dame Barbara Stocking. “Solidarity, because we’re all in this together, and solidarity is in our own self-interest,” explained Stocking. “Equity: there must be equal access to vaccines and treatments, but also an equal voice in decision-making. Transparency in reporting data and samples. Accountability, as the lack of accountability of countries is the fundamental reason that we are in disarray.” The hearings continue at 8am CET on Wednesday and can be followed live. Image Credits: WHO African Region. Nineteen More Attacks on Ukraine’s Health Facilities Since Friday: WHO 11/04/2022 Kerry Cullinan Ukraine operating theatre destroyed The World Health Organization (WHO) has verified 108 attacks on health care in Ukraine as of Monday in which 73 people have died and 51 have been injured. That is 19 more attacks on health facilities than the already deadly toll of 91 attacks that had been verified by WHO as of early Friday afternoon, and as reported at a press conference by WHO’s Regional Director Hans Kluge in Lviv. .@WHO has verified 5 additional reports of attacks on health care in #Ukraine. As of 11 April, 108 attacks on health care in Ukraine have been verified, causing 73 deaths and 51 injuries. We are outraged that attacks on health care are continuing. pic.twitter.com/8GNUQZFiK9 — WHO Ukraine (@WHOUkraine) April 11, 2022 Meanwhile, the Office of the UN High Commissioner for Human Rights (OHCHR) has recorded 1,793 civilian deaths and 2,439 injuries since the start of the Russian invasion on 24 February and Sunday. Most of the civilian casualties have been caused by “explosive weapons with a wide impact area”, including shelling from heavy artillery and rocket, missile and air strikes. https://data.humdata.org/visualization/ukraine-humanitarian-operations/ “OHCHR believes that the actual figures are considerably higher, as the receipt of information from some locations where intense hostilities have been going on has been delayed and many reports are still pending corroboration,” according to a statement from the office. “This concerns, for example, Mariupol (Donetsk region), Izium (Kharkiv region), Popasna (Luhansk region), and Borodianka (Kyiv region), where there are allegations of numerous civilian casualties. These figures are being further corroborated and are not included in the above statistics.” According to the Prosecutor General’s Office of Ukraine, 176 children had been killed and at least 336 injured as of Sunday. Image Credits: WHO. Pfizer Refuses Cooperation with DNDi on Study of Paxlovid Treatment Adapted to Low Income Countries 08/04/2022 Elaine Ruth Fletcher & Kerry Cullinan Paxlovid Pfizer has so far refused an invitation from the Geneva-based Drugs for Neglected Diseases Initiative (DNDi) to cooperate on a study exploring whether the treatment window of its successful antiviral drug, Paxlovid, could be extended from 5-7 days using another drug compound in addition, Dr Nathalie Strub-Wourgaft, Director of DNDi’s COVID-19 Response, told Health Policy Watch. DNDi wants to test if the key active ingredient of Paxlovid, nirmatrelvir, could be offered in combination with an inhaled corticosteroid, budesonide, in order to extend the treatment window of the life-saving COVID treatment by two more days, Strub-Wourgaft said in an interview. Extending the treatment window is critical for patients in low-income countries because the currently-approved formulation of Paxlovid must be commenced within 3-5 days of COVID symptoms. Meanwhile ANTICOV, a major DNDi-sponsored trial of COVID treatments underway in ten African countries, has revealed that one-half of COVID patients present for treatment after the five day cut-off date. ANTICOV clinical trial. That makes the current Paxlovid combination less than suitable for low- and middle-income country (LMIC) conditions, said Strub-Wourgaft. She is one of the coordinators of the ANTICOV Consortium, a group of 26 African and global research organizations engaged in the clinical trial research on novel COVID drugs for LMICs. On 15 March, DNDi issued a public statement expressing its concern that “efforts to conduct urgently needed studies in low- and middle-income countries (LMICs) utilizing the novel oral antiviral, nirmatrelvir/ritonavir (Paxlovid), are being blocked by Pfizer, which developed the drug. Paxlovid, which uses the common HIV drug ritonavir in combination with nirmatrelvir, has been found to reduce the risk of hospitalization or death by a stunning 89% in patients at high risk of severe COVID-19 disease. But the treatment needs to be taken within three to five days of patients developing symptoms. According to DNDi, “an interim analysis done in the context of the ongoing ANTICOV clinical trial conducted in 10 African countries showed that of the 1180 patients enrolled, more than half present for care after day 5. “To overcome this challenge, it is necessary to explore whether using Paxlovid with other drugs could widen the ‘treatment window’ to at least seven days,” DNDi said in its statement. DNDi also wants to investigate if the drug could be “beneficial for immune-suppressed patients who are the most vulnerable to disease progression but were excluded from phase 3 trials.” DNDi, a Geneva-based not-for-profit research and development organisation, works to deliver new treatments on neglected diseases and serving neglected groups in low- and middle-income countries. Still looking for ways to access nirmatrelvir DNDi drug development. Strub, in her comments to Health Policy Watch, suggested that DNDi, which has a good track record of building cooperation with the pharma industry, was still trying to obtain the drug somehow – or even persuade Pfizer to collaborate. “We would like to test nirmatrelvir/ritonavir in combination, as well, with inhaled budesonide or maybe fluoxetine (brand name Prozac),” said Strub-Wourgaft. “We issued a statement to say that we had asked Pfizer to get access to nirmatrelvir, to work with us on this trial. They denied. We’re continuing to try to get access to this drug.” “We think this [combination] would extend the window of treatment to seven days of symptoms. In the study that they [Pfizer] have done, which is a great study showing really fantastic results, they looked at patients who had five days of symptoms before they were enrolled. “And we have seen for now, in our study in Africa, that half of the patients come after five days of symptoms,” she said. Such delays are typical because COVID diagnosis and treatment services are less widely available and it thus takes people longer to get diagnosed, even if they are symptomatically ill. “There are critically important public health research questions that must be answered quickly – particularly in low- and middle-income countries where access to vaccines remains low,” added Strub-Wourgaft, in the DNDi statement. “It is difficult to understand any rationale for refusing to cooperate in the midst of a global pandemic, and this sets a dangerous precedent since there are many other promising antivirals in the pipeline and these novel treatments will also require follow-on research to determine their optimal use in resource-limited settings.” MPP deal with Pfizer – not enough Pfizer recently signed a deal with another Geneva-based group, the non-profit Medicines Patent Pool, that will allow 35 new manufacturers to produce and supply generic versions of Paxlovid to some 95 low- and middle income countries – in what the company has said is a move to lower the drug’s cost and expand access in low-income countries. But that deal has also been criticised for failing to cover dozens of other middle-income and upper-middle income countries that will have to purchase patented versions of the drug. Although Pfizer had also said that it would create a tiered pricing system for Paxlovid, drug price advocates say that the price remains too high in many settings. In the United States, the government pays Pfizer about $530 for a five day course, although the pills also are in short supply in some US communities. In addition, most of Pfizer’s Paxlovid supply for the first half of 2022 has already been bought up by rich countries, meaning that LMICs will only be able to get about 10 million doses of the drug in the near term. Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates However, even considering the MPP deal and other preferential pricing mechanisms, the fact remains that the version of Paxlovid currently being produced is not an optimal fit for many LMICs, Strub-Wourgaft said. “So for now, if we were to be able to give them Paxlovid, under the current conditions, half of them would not even have access,” she told Health Policy Watch. MPP deals with generic manufacturers may not enable supplies to ANTICOV DNDi is also concerned about the potential difficulty of obtaining generic versions of Paxlovid to conduct the new ANTICOV combination studies, the company has said. “The terms of the Pfizer/Medicines Patent Pool (MPP) licensing agreement to the new generics manufacturers could be interpreted to mean that sub-licensees cannot provide nirmatrelvir/ritonavir for use in the sorts of combination studies that DNDi and others wish to conduct, unless they have explicit written approval from Pfizer. “Some generic manufacturers are also encountering difficulties obtaining Paxlovid as a ‘reference drug’ so that they can conduct the necessary bioequivalence studies to show regulators that their generic version has the same effect in the body, effectively blocking availability of generics for both research and clinical use”, DNDi added in its statement. It has therefore asked Pfizer to not only provide access to nirmatrelvir/ritonavir (Paxlovid) for the DNDi-coordinated ANTICOV trial and other relevant clinical trials, but also to: Remove any ambiguities or restrictions in the Pfizer-MPP licensing agreement that could prevent sub-licensees from supplying such research studies (or publicly clarify that no such restrictions exist); Provide access to Pfizer’s originator product as a ‘reference drug’ so that any interested generic manufacturer can conduct the necessary bioequivalence studies for regulatory approval; and Allocate sufficient quantities of Paxlovid specifically for LMICs and remove all barriers to access to generic nirmatrelvir/ritonavir to enable scale up for care and treatment in LMICs. “Every effort should be made to ensure that clinical studies for COVID-19 treatment are conducted in low- and middle-income countries, and that any products developed reach vulnerable populations,” said Dr John Amuasi, head of the Global Health and Infectious Diseases Research Grou at Kumasi Center for Collaborative Research in Tropical Medicine in Ghana and a principal investigator for ANTICOV. “We must not arrive at a situation where research priorities are determined by the actions or inactions of any company.” Pfizer response – committed to well-controlled trials In response to a request from Health Policy Watch, a Pfizer spokesperson did not provide any clarification of the reasons behind the company’s refusal to participate in the DNDi trial – aimed a making the treatment more suitable to low-income settings. “Pfizer appreciates the importance of gathering additional data and information for governments to help maximize the public health response to the COVID-19 pandemic,” said the spokesperson, adding that the company is committed to “well-controlled, hypothesis-driven clinical studies that can provide data that will be accepted by global regulatory agencies. “Additional studies of PAXLOVID are underway or are being explored, and we will continue to share information as we have it,” the spokesperson added. In addition, “Right now, we are focusing our efforts and resources in a way that maximizes availability of our overall supply, to help ensure access to patients as quickly as possible,” the spokesperson said, noting that the company remains “confident” in the clinical trial results, which showed an 88-89% efficacy rate for the drug, when it was administered to non-hospitalized, high-risk patients within 3-5 days of symptom onset. -Updated 9 April with correction on the price of Paxlovid paid by the US government for patients in the USA and on 11 April with details of Pfizer response. Image Credits: Bobbi-Jean MacKinnon, DNDI/Twitter, DNDi. Artificial Intelligence ‘Boot Camp’ Aims to Accelerate Drug Discovery 08/04/2022 Maayan Hoffman Machine learning is playing an increasingly important role in computing and artificial intelligence. TEL AVIV – Ninety percent of drug candidates fail in clinical trials because of unexpected safety issues or lack of efficacy in human subjects, according to Noga Yerushalmi, Investment Director at M Ventures, the strategic, corporate venture capital arm of Merck. There have been dramatic improvements in omics technologies – that is the collective technologies used to explore molecular behaviour, such as genomics, proteomics, metabolomics, metagenomics and transcriptomics. And this is enabling scientists to analyze potential drug targets more efficiently in terms of their potential impact on a pathogen or disease. But there is no automated solution that harnesses all preclinical data in a way that allows for a reliable assessment of the clinical trial readiness of a new drug candidate. Now, some pharma and research initiatives are hoping to change that, among them AION Labs. Together with its German partner BioMed X, the Israeli-based research alliance, hosted 15 teams of computational biologists, AI researchers and biomedical scientists for a ‘boot camp’ that aims to speed up the drug discovery process and lower costs – harnessing AI technologies in novel ways. Mission: identify critical safety issues before expensive clinical trial stage The latest boot camp cohort The teams were charged with making a proposal for the development of a versatile, next-generation computational platform that can identify hidden safety liability and lack of efficacy, and close identified gaps in the drug candidate pre-clinical data package. “The big problem in drug discovery and development is that after a lot of experiments have been done and we have a new drug candidate, many of these candidates fail in very expensive clinical trials in humans,” Dr. Christian Tidona, founder and managing director of the BioMed X Institute told Health Policy Watch. “That’s because humans are different from mice or a dish in the lab.” The challenge is that pharma companies usually only discover that a drug candidate either is not safe or will not work after years of effort and hundreds of millions of dollars of investment. Companies can invest $5 billion and 12-years’ time, on average, Tidona said, to create the next “blockbuster drug.” “When one thinks about these numbers, he can imagine why some of these drugs are so expensive. Could an AI platform predict if a drug is really ready for the clinic and, if not, tell us what was missed before we go to trial?” Tidona asked. “This is the question. “If drugs can be made more efficiently, medicines can become cheaper and more people in all parts of the world could afford them,” he said. Solving therapeutic challenges Kahina Lang, head of Strategic Innovation at Merck Group, addresses the candidates at the AION Labs boot camp. Based in Rehovot, not far from the the famed Weizmann Institute, AION brings together some of the biggest names in pharma, including AstraZeneca, Merck, Pfizer, and Teva, with young biotech inventors and entrepreneurs, to crack biomedical research challenges together and in a novel way. “We work with each of our pharma partners separately and then together to identify the top research challenges that solving would be majorly impactful for the industry at large,” AION CEO Mati Gill told Health Policy Watch. Then, AION looks for innovators and scientists to develop solutions for them. For last week’s boot camp, 15 applicants from around the world were selected to come to Israel and participate. “The winner receives a $2 million investment, mentorship and access to a wealth of data for model training from these four big pharma companies,” Tidona said. “It is more or less paradise for anyone who wants to start a company.” The concept is based on a model Tidona first developed on the campus of the University of Heidelberg in Germany, with a world-wide network of partner locations. If the company succeeds, the technology belongs to it but will be made available for purchase by the pharma partners. ‘Bringing the promise of AI to fruition’ Guy Spigelman of AWS addresses candidates at the AION Labs bootcamp. Merck’s Yerushalmi said that there have been “all kinds of efforts to make the drug development model more efficient – to expedite it,” but until now it has not worked. When computational approaches to research were first introduced, “it brought a lot of promise, but until now it has not brought as much fruit as we hoped. Now, with AI tools and the amount of data pharma and other companies can generate, we do hope we may be able to bring this promise to fruition.” AI is one of the most sophisticated computational tools. AI analysis has brought “ingenious” solutions to other fields, like the automotive industry, she pointed out. “AI tools and big data have proven themselves in so many other cases, I think it will probably work for our industry too,” Yerushalmi said. “Want to make [drug development] more affordable and shorter, so we can bring drugs to the market faster and cheaper for the benefit of humanity.” Finding the most effective antibodies AION will be looking for the next therapeutic antibodies. This most recent boot camp was AION’s second one so far. Earlier this year, it invited computational biologists and biomedical scientists to propose ideas for discovering therapeutic antibodies. “Advances in protein structure prediction, artificial intelligence algorithms, and increased availability of experimentally determined antigen-antibody structures present a unique opportunity for AI-driven antibody discovery,” AION said in a release. In the coming months, it will hold a third boot camp at which computational biologists, bioinformatics and cheminformatics scientists and AI researchers will propose ideas for the development of a next-generation computational platform to optimize antibodies for targeted therapies with enhanced properties, including developability or manufacturability, stability, aggregation, immunogenicity, pharmacokinetics and tissue distribution. “The ultimate solution is an AI platform that receives sequences of binders and generates novel variants with optimized IgG sequences, biophysical and targeting properties,” a background briefing explained. “The goal of the AI algorithm is to make an existing antibody a better drug while reducing design iterations, optimization of cycle times and lowering attrition rates.” CEPI launches AI-based quest for beta-coronavirus vaccine candidate The AION initiative, while pioneering in the use of AI for drug discovery, is not the only one. On Thursday, the Oslo-based Coalition for Epidemic Preparedness (CEPI) announced that it would provide seed funding of up to US $4.8 million to a consortium to support the AI-based development of betacoronavirus vaccine candidates – the new holy grail for coronavirus vaccines. The research consortium, led by a Norway-based subsidiary of the Japanese NEC Group, which specializes in AI technologies, also includes the European Vaccine Initiative (EVI) and Oslo University Hospital. It aims to establish preclinical proof of concept for an mRNA-based vaccine that protects against a broad range of beta coronaviruses – rather than SARS-CoV2 alone, said CEPI in a press release. NEC will apply its experience in the AI design of immunogens to identify novel vaccine antigens with broad reactivity against beta-coronaviruses. The lead antigens will be selected iteratively and validated in preclinical studies against known beta coronaviruses that already pose a significant epidemic or pandemic risk, such as SARS-CoV, SARS-CoV-2 and MERS-CoV. If the approach is successful, it may also be applicable for developing vaccines against other pathogens in the CEPI portfolio, including ‘Disease X’ – unknown pathogens with pandemic potential that have yet to emerge. What the future holds What the future of AI holds. Tidona, for his part, hopes that AION will spin off 20 new start-ups in the next four to six years. “We are building an innovation ecosystem,” he said, noting that it is attractive to host countries as it provides a draw for youthful talent, which in turn spurs economic development. He added that if the model works well, BioMed X plans to export it to other countries as well. “The focus now is on Israel as our first partner outside Germany,” Tidona said. “But in the future, we hope to have sites” in other places, too. Image Credits: https://www.flickr.com/photos/mikemacmarketing/42271822770/, AION Labs, Elad Malka, Twitter: @WHO, https://www.flickr.com/photos/158301585@N08/43267970922/. Global Health Leaders Call on African Policymakers To Do More to Stop Climate Change 08/04/2022 Paul Adepoju WHO argues that climate-smart initiatives are good for health. But the health sector receives less than 1% of international climate finance, said Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC). Global health leaders have repeatedly called for stepped up investments to both slow down climate change and recognize the health co-benefits of more climate action. But political leaders, including those in low and middle-income countries, still need to do more, Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC) told Health Policy Watch in a briefing on Thursday, World Health Day. Meanwhile, WHO’s Regional Director for Africa, Matshidiso Moeti, enjoined African governments to “prioritize human wellbeing in every strategy and decision,” including halting fossil fuel expansion that ultimately will boomerang on the countries concerned. “I’d like to take this opportunity to call on an African governments to prioritize human wellbeing in every strategy and decision to halt new fossil fuel exploration and subsidies, institute taxes for polluting firms and to implement the WHO air quality guidelines for example,” said Moeti, speaking on this year’s World Health Day theme, ‘Our Planet, Our Health.’ Added Cissé, countries that harness more of their own national and local policies, innovations and resources can make a difference. “Countries can go for some financial incentive policy at a national scale that includes taxes and subsidies; they can also have some innovative policies regarding insurance. They can also give some small scale financial products to low income and other households,” Cissé said. Support to health sector less than 1% of international climate finance Experts are increasingly aware of the multi-faced impacts of the climate crisis on health – as well and the increased precarity of health in the face of deforestation and biodiversity loss as well as unhealthy foods production – which are also driving climate change. So far, however, support to the health sector for climate action still comprises less than 1% of international climate finance investments, Cissé said, speaking at a WHO African Region World Health Day briefing. Health co-benefits of climate mitigation strategies – for instance fewer air pollution-related deaths from cleaner energy investments, also go uncounted in climate strategies. This, despite health being mentioned as a priority in 54% of countries’ Nationally Determined Contributions (NDCs), which are the main instruments now being used for global climate pledges to reduce harmful emissions, under the UN Framework Convention on Climate Change. Cissé who works with the Swiss Tropical and Public Health Institute at the University of Basel in Switzerland, noted that this reflects the low priority still being given to climate change in the context of health. World Health Day at a time of heightened conflict and fragility Joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra (center) and WHO Director-General Dr Tedros Adhanom Ghebreyesus (right) This year’s World Health Day, which marks the April 7, 1948 date of WHO’s founding, comes at a time of both heightened political conflict and greater ecosystem fragility, noted WHO Director-General Dr Tedros Adhanom Ghebreyesus. He was speaking at a joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra. “The pandemic has highlighted the intimate links between the health of humans, animals and the environment. And yet, we’re rapidly making the planet on which all life depends and inhabitable… “The climate crisis is a health crisis,” Tedros said at the Thursday briefing, which concluded a series of face-to-face meetings this week with US Administration officials – the first since President Joe Biden’s inauguration last year. ”Air pollution kills 7 million people every year. And 99% of the world’s population breathes unhealthy air mainly as a result of burning fossil fuels,” Tedros added. (see related story) “Our warming world is facilitating the spread of mosquitoes and diseases they carry. Extreme weather events, biodiversity loss, land degradation, and water scarcity are displacing people and damaging their health,” Tedros said. “Systems that produce highly processed, unhealthy foods are driving a wave of obesity, increasing cancer and heart disease, and generating one-third of greenhouse gas emissions. “As the world recovers from the pandemic we have a choice: we can go back to the way things were or we can change course. We can create societies, economies and products that nurture health and well being, and stop subsidizing those that destroy – because we cannot afford to pump carbon into the atmosphere at the same rate, and still breathe clean air. “We cannot afford the same patterns of consumption and expect less diabetes, hypertension, heart disease and cancer. We must choose. We cannot afford ever-deepening inequalities and expect continued prosperity. We must choose.” Half new fossil fuel exploration and subsidies, prioritize health, says WHO Regional Director Water shortage in Ethiopia. Population exposure to heat is increasing due to climate change. Globally, extreme temperature events are observed to be increasing in their frequency, duration, and magnitude. In Africa, one of the regions of the world that is worst affected by climate change, extreme weather events are having ever greater impacts on food security, water access, and related to that, nutrition and disease transmission. Of the more than 2000 public health events recorded in the African region between 2019 and 2020, more than half were climate-related, said Moeti, speaking from WHO’s Regional Office in Brazzaville. This, she said, represented a 25% increase compared with the previous decade. “In Africa, diarrhoeal diseases are the third leading cause of death and illness in children younger than five, which could be preventable with safe drinking water, adequate sanitation and hygiene, and installation,” Moeti said. “Our analysis showed that waterborne diseases, mainly due to cholera outbreaks, accounted for 40% of climate-related health emergencies in the past 20 years.” In urging African governments to adopt cleaner, healthier policies, she said the main motive is really self-preservation. “Älthough Africa contributes the least to global warming, the continent bears a disproportionate burden of the consequences,” said Moeti. “It’s up to every one of us to promote and support multi-sectoral interventions that address the threat of climate change, while helping to better prepare for future health shocks like the COVID-19 pandemic.” Image Credits: Oxfam East Africa. 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.
Championing Health Equity in South Africa – Global Health Matters Podcast Series 13/04/2022 Editorial team The second season of the Global Health Matters podcast series kicks off with a close-up look at South Africa’s health equity initiatives and champions. Health Policy Watch will be featuring episodes from the series throughout the coming year as part of a TDR-supported series. As the world commits to equitable access to medicines and vaccines, is this just on paper or a reality? In the case of COVID-19, as of early April 2022, 74% of people in high-income countries had been fully vaccinated, compared with just 15% in Africa and 11% of people in low-income countries worldwide. With 30% of people fully vaccinated, South Africa, has one of the highest COVID vaccination rates in sub-Saharan Africa. And it has been an African leader in the manufacture of COVID vaccines, as well as a leader in the global campaign to waive intellectual property rights on COVID vaccines, tests and treatment – not to mention the historic role it played a generation ago in the legal battles that paved the way for the widespread manufacture of low-cost, generic antivirals for HIV treatment. Can South Africa’s experience with tackling HIV/AIDS and COVID-19 point to future solutions for other low- and middle-income countries? And how has the state of play regarding intellectual property rights for COVID health products affected development of vaccines across Africa? Global Health Matters podcast host Garry Aslanyan fields these and other questions to three leading South Africans scientists, policymakers and health activists, including Fatima Hassan (founder of the Health Justice Initiative), Petro Terblanche (Managing Director of Afrigen Biologics), and Judit Rius Sanjuan (Policy Specialist at UNDP). Click here to catch this episode, the first of the second season of TDR’s Global Health Matters podcast. Find it on YouTube: Championing Health Equity in South Africa Link here for all Season 1 episodes of Global Health Matters. Historic Public Hearings on WHO Pandemic Instrument; Some Unhappiness with Process 12/04/2022 Kerry Cullinan The last Ebola patient leaves a treatment centre in the Democratic Republic of Congo at the end of March 2021, marking the countdown to declaring the end of that pandemic. The World Health Organization (WHO) convened public hearings for only the second time in its history on Tuesday, asking interested parties what substantive issues should be contained in its proposed international instrument on pandemic preparedness and response. The first and only other WHO hearings were held 22 years ago in the run-up to the adoption of the Framework Convention on Tobacco Control, according to WHO principal legal officer Steven Solomon. Welcoming the public hearing, WHO Director-General Dr Tedros Adhanom Ghebreyesus said that informed opinion and active public cooperation are of the utmost importance to improve health, and it was important to learn from the COVID-19 pandemic to ensure the world is “better prepared” for the next pandemic. Tedros had been mandated by last year’s World Health Assembly Special Session to convene public hearings to inform the work of the Intergovernmental Negotiating Body (INB) which is in charge of negotiating the pandemic instrument or treaty. INB co-chair, South Africa’s Dr Precious Matsoso, described the hearings as “remarkable” and “historic”. Dr Precious Matsoso, INB co-chair Narrow responsibility However, the Civil Society Alliance for Human Rights in the Pandemic Treaty warned that the consultative process risks being “inadequate”. “While this week’s public hearings reflect the INB’s stated objective to consult the public to some extent, it has interpreted its responsibility to do so very narrowly,” according to the alliance. “The INB has allocated minimal time to engaging with the wide range of stakeholders who could inform the process and improve both the legitimacy and quality of the Treaty that emerges.” Dr Meg Davis, from the Global Health Centre at the Graduate Institute in Geneva, also said that participants had been given no indication of whether or how their submissions would be included in the negotiations and recommended policymaking models to ensure meaningful civil society engagement. A number of organisations gave two-minute speeches focusing on a wide range of issues including ‘One Health’, research and development (R&D) and intellectual property rights at the hearings, which continue on Wednesday and then reconvene in mid-June. Equity means sharing Research and Development Professor Suerie Moon, co-director of the Global Health Centre at the Graduate Institute in Geneva. All member states have committed to equity at the heart of any pandemic instrument, but Professor Suerie Moon, co-director of the Geneva Graduate Institute’s Global Health Centre, told the hearings that “equity requires collective research and development of vaccines, drugs and diagnostics”. Pointing out that COVID-19 has led to the development of technology transfer hubs in South Africa and the Republic of Korea, Moon warned that “there’s a risk that new factories will sit idle in the next emergency unless the new international instrument forges agreement on obligations to share knowledge, data and intellectual property before and during future emergencies”. “It’s unlikely, however, that countries or companies will do so out of the goodness of their hearts,” added Moon. “To make such sharing feasible, we have to tie it to commitments to jointly finance research and development to share pathogen samples and genomic sequencing data. In other words, the key idea is collective research and development for collective benefit.” Acknowledging that intellectual property was a difficult issue, Moon nonetheless said that if equitable access was to become a reality “the new instrument must include the nuts-and-bolts provisions to make sharing technology for pandemics the new normal”. To address IP, Knowledge Ecology International (KEI) recommended that governments should “agree to collectively use exceptions to intellectual property rights that are permitted in existing trade agreements and treaties”. “A model for this is the WIPO Marrakesh Treaty for the Blind, which mandates its members to use exceptions in copyrights to enhance global access to works made accessible to persons who are blind or have other disabilities,” according to KEI’s James Love. KEI also proposed “a robust chapter on transparency”, adding that “the lack of transparency in many areas for the current pandemic is an appalling and unnecessary policy failure, and one that both makes it more difficult to manage a pandemic response, and undermines the public’s trust in institutions”. Rachael Crockett from the Drugs for Neglected Diseases initiative (DNDi) stressed the need to co-ordinate R&D as a substantive element of the new instrument. DNDi wants R&D priority setting, and “globally agreed norms and binding rules that govern the R&D process, including transparency and open sharing of research, data, knowledge, technology, and equitable allocation of health tools”. Sharing pathogens IFPMA’s Grega Kumer Grega Kumer from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) said “any system should be built on what worked well during the COVID pandemic, in particular, immediate sharing of pathogens and a robust response from the IP based private sector”. The IFPMA presented eight core principles, including that the negotiation process should be “inclusive and transparent, involving the private sector and all critical contributors to pandemic preparedness efforts”. “Any system should allow for immediate access of pathogens and genetic sequence data and correct the negative effects of access and benefit-sharing legislation,” said Kumer. The IFPMA also supports more equitable access to tests, treatments and vaccines “based on medical need, thus enhancing solidarity and facilitating emergency financing to institutions procuring for developing countries”, and the protection of supply chains ”from arbitrary export restrictions and other trade barriers”. “While the public sector might play a larger role in pandemic setting, the system should build on the private sector strengths for R&D, manufacturing and distribution,” he concluded. One Health is key The need for any pandemic instrument to adopt a One Health approach also emerged as a key theme. Dame Sally Davies, speaking for the UN Global Leaders Group on Antimicrobial Resistance (AMR), said that they wanted AMR to be integrated alongside a primary focus on pandemics. “The next pandemic could be drug-resistant, or could depend on antimicrobials to mitigate it,” said Davies, saying that one health surveillance needed to be at the heart of any pandemic treaty to enable “rapid, transparent and responsive protection”. Governance principles The Panel for a Global Health Convention believes the instrument must be governed by four non-negotiable principles, according to Dame Barbara Stocking. “Solidarity, because we’re all in this together, and solidarity is in our own self-interest,” explained Stocking. “Equity: there must be equal access to vaccines and treatments, but also an equal voice in decision-making. Transparency in reporting data and samples. Accountability, as the lack of accountability of countries is the fundamental reason that we are in disarray.” The hearings continue at 8am CET on Wednesday and can be followed live. Image Credits: WHO African Region. Nineteen More Attacks on Ukraine’s Health Facilities Since Friday: WHO 11/04/2022 Kerry Cullinan Ukraine operating theatre destroyed The World Health Organization (WHO) has verified 108 attacks on health care in Ukraine as of Monday in which 73 people have died and 51 have been injured. That is 19 more attacks on health facilities than the already deadly toll of 91 attacks that had been verified by WHO as of early Friday afternoon, and as reported at a press conference by WHO’s Regional Director Hans Kluge in Lviv. .@WHO has verified 5 additional reports of attacks on health care in #Ukraine. As of 11 April, 108 attacks on health care in Ukraine have been verified, causing 73 deaths and 51 injuries. We are outraged that attacks on health care are continuing. pic.twitter.com/8GNUQZFiK9 — WHO Ukraine (@WHOUkraine) April 11, 2022 Meanwhile, the Office of the UN High Commissioner for Human Rights (OHCHR) has recorded 1,793 civilian deaths and 2,439 injuries since the start of the Russian invasion on 24 February and Sunday. Most of the civilian casualties have been caused by “explosive weapons with a wide impact area”, including shelling from heavy artillery and rocket, missile and air strikes. https://data.humdata.org/visualization/ukraine-humanitarian-operations/ “OHCHR believes that the actual figures are considerably higher, as the receipt of information from some locations where intense hostilities have been going on has been delayed and many reports are still pending corroboration,” according to a statement from the office. “This concerns, for example, Mariupol (Donetsk region), Izium (Kharkiv region), Popasna (Luhansk region), and Borodianka (Kyiv region), where there are allegations of numerous civilian casualties. These figures are being further corroborated and are not included in the above statistics.” According to the Prosecutor General’s Office of Ukraine, 176 children had been killed and at least 336 injured as of Sunday. Image Credits: WHO. Pfizer Refuses Cooperation with DNDi on Study of Paxlovid Treatment Adapted to Low Income Countries 08/04/2022 Elaine Ruth Fletcher & Kerry Cullinan Paxlovid Pfizer has so far refused an invitation from the Geneva-based Drugs for Neglected Diseases Initiative (DNDi) to cooperate on a study exploring whether the treatment window of its successful antiviral drug, Paxlovid, could be extended from 5-7 days using another drug compound in addition, Dr Nathalie Strub-Wourgaft, Director of DNDi’s COVID-19 Response, told Health Policy Watch. DNDi wants to test if the key active ingredient of Paxlovid, nirmatrelvir, could be offered in combination with an inhaled corticosteroid, budesonide, in order to extend the treatment window of the life-saving COVID treatment by two more days, Strub-Wourgaft said in an interview. Extending the treatment window is critical for patients in low-income countries because the currently-approved formulation of Paxlovid must be commenced within 3-5 days of COVID symptoms. Meanwhile ANTICOV, a major DNDi-sponsored trial of COVID treatments underway in ten African countries, has revealed that one-half of COVID patients present for treatment after the five day cut-off date. ANTICOV clinical trial. That makes the current Paxlovid combination less than suitable for low- and middle-income country (LMIC) conditions, said Strub-Wourgaft. She is one of the coordinators of the ANTICOV Consortium, a group of 26 African and global research organizations engaged in the clinical trial research on novel COVID drugs for LMICs. On 15 March, DNDi issued a public statement expressing its concern that “efforts to conduct urgently needed studies in low- and middle-income countries (LMICs) utilizing the novel oral antiviral, nirmatrelvir/ritonavir (Paxlovid), are being blocked by Pfizer, which developed the drug. Paxlovid, which uses the common HIV drug ritonavir in combination with nirmatrelvir, has been found to reduce the risk of hospitalization or death by a stunning 89% in patients at high risk of severe COVID-19 disease. But the treatment needs to be taken within three to five days of patients developing symptoms. According to DNDi, “an interim analysis done in the context of the ongoing ANTICOV clinical trial conducted in 10 African countries showed that of the 1180 patients enrolled, more than half present for care after day 5. “To overcome this challenge, it is necessary to explore whether using Paxlovid with other drugs could widen the ‘treatment window’ to at least seven days,” DNDi said in its statement. DNDi also wants to investigate if the drug could be “beneficial for immune-suppressed patients who are the most vulnerable to disease progression but were excluded from phase 3 trials.” DNDi, a Geneva-based not-for-profit research and development organisation, works to deliver new treatments on neglected diseases and serving neglected groups in low- and middle-income countries. Still looking for ways to access nirmatrelvir DNDi drug development. Strub, in her comments to Health Policy Watch, suggested that DNDi, which has a good track record of building cooperation with the pharma industry, was still trying to obtain the drug somehow – or even persuade Pfizer to collaborate. “We would like to test nirmatrelvir/ritonavir in combination, as well, with inhaled budesonide or maybe fluoxetine (brand name Prozac),” said Strub-Wourgaft. “We issued a statement to say that we had asked Pfizer to get access to nirmatrelvir, to work with us on this trial. They denied. We’re continuing to try to get access to this drug.” “We think this [combination] would extend the window of treatment to seven days of symptoms. In the study that they [Pfizer] have done, which is a great study showing really fantastic results, they looked at patients who had five days of symptoms before they were enrolled. “And we have seen for now, in our study in Africa, that half of the patients come after five days of symptoms,” she said. Such delays are typical because COVID diagnosis and treatment services are less widely available and it thus takes people longer to get diagnosed, even if they are symptomatically ill. “There are critically important public health research questions that must be answered quickly – particularly in low- and middle-income countries where access to vaccines remains low,” added Strub-Wourgaft, in the DNDi statement. “It is difficult to understand any rationale for refusing to cooperate in the midst of a global pandemic, and this sets a dangerous precedent since there are many other promising antivirals in the pipeline and these novel treatments will also require follow-on research to determine their optimal use in resource-limited settings.” MPP deal with Pfizer – not enough Pfizer recently signed a deal with another Geneva-based group, the non-profit Medicines Patent Pool, that will allow 35 new manufacturers to produce and supply generic versions of Paxlovid to some 95 low- and middle income countries – in what the company has said is a move to lower the drug’s cost and expand access in low-income countries. But that deal has also been criticised for failing to cover dozens of other middle-income and upper-middle income countries that will have to purchase patented versions of the drug. Although Pfizer had also said that it would create a tiered pricing system for Paxlovid, drug price advocates say that the price remains too high in many settings. In the United States, the government pays Pfizer about $530 for a five day course, although the pills also are in short supply in some US communities. In addition, most of Pfizer’s Paxlovid supply for the first half of 2022 has already been bought up by rich countries, meaning that LMICs will only be able to get about 10 million doses of the drug in the near term. Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates However, even considering the MPP deal and other preferential pricing mechanisms, the fact remains that the version of Paxlovid currently being produced is not an optimal fit for many LMICs, Strub-Wourgaft said. “So for now, if we were to be able to give them Paxlovid, under the current conditions, half of them would not even have access,” she told Health Policy Watch. MPP deals with generic manufacturers may not enable supplies to ANTICOV DNDi is also concerned about the potential difficulty of obtaining generic versions of Paxlovid to conduct the new ANTICOV combination studies, the company has said. “The terms of the Pfizer/Medicines Patent Pool (MPP) licensing agreement to the new generics manufacturers could be interpreted to mean that sub-licensees cannot provide nirmatrelvir/ritonavir for use in the sorts of combination studies that DNDi and others wish to conduct, unless they have explicit written approval from Pfizer. “Some generic manufacturers are also encountering difficulties obtaining Paxlovid as a ‘reference drug’ so that they can conduct the necessary bioequivalence studies to show regulators that their generic version has the same effect in the body, effectively blocking availability of generics for both research and clinical use”, DNDi added in its statement. It has therefore asked Pfizer to not only provide access to nirmatrelvir/ritonavir (Paxlovid) for the DNDi-coordinated ANTICOV trial and other relevant clinical trials, but also to: Remove any ambiguities or restrictions in the Pfizer-MPP licensing agreement that could prevent sub-licensees from supplying such research studies (or publicly clarify that no such restrictions exist); Provide access to Pfizer’s originator product as a ‘reference drug’ so that any interested generic manufacturer can conduct the necessary bioequivalence studies for regulatory approval; and Allocate sufficient quantities of Paxlovid specifically for LMICs and remove all barriers to access to generic nirmatrelvir/ritonavir to enable scale up for care and treatment in LMICs. “Every effort should be made to ensure that clinical studies for COVID-19 treatment are conducted in low- and middle-income countries, and that any products developed reach vulnerable populations,” said Dr John Amuasi, head of the Global Health and Infectious Diseases Research Grou at Kumasi Center for Collaborative Research in Tropical Medicine in Ghana and a principal investigator for ANTICOV. “We must not arrive at a situation where research priorities are determined by the actions or inactions of any company.” Pfizer response – committed to well-controlled trials In response to a request from Health Policy Watch, a Pfizer spokesperson did not provide any clarification of the reasons behind the company’s refusal to participate in the DNDi trial – aimed a making the treatment more suitable to low-income settings. “Pfizer appreciates the importance of gathering additional data and information for governments to help maximize the public health response to the COVID-19 pandemic,” said the spokesperson, adding that the company is committed to “well-controlled, hypothesis-driven clinical studies that can provide data that will be accepted by global regulatory agencies. “Additional studies of PAXLOVID are underway or are being explored, and we will continue to share information as we have it,” the spokesperson added. In addition, “Right now, we are focusing our efforts and resources in a way that maximizes availability of our overall supply, to help ensure access to patients as quickly as possible,” the spokesperson said, noting that the company remains “confident” in the clinical trial results, which showed an 88-89% efficacy rate for the drug, when it was administered to non-hospitalized, high-risk patients within 3-5 days of symptom onset. -Updated 9 April with correction on the price of Paxlovid paid by the US government for patients in the USA and on 11 April with details of Pfizer response. Image Credits: Bobbi-Jean MacKinnon, DNDI/Twitter, DNDi. Artificial Intelligence ‘Boot Camp’ Aims to Accelerate Drug Discovery 08/04/2022 Maayan Hoffman Machine learning is playing an increasingly important role in computing and artificial intelligence. TEL AVIV – Ninety percent of drug candidates fail in clinical trials because of unexpected safety issues or lack of efficacy in human subjects, according to Noga Yerushalmi, Investment Director at M Ventures, the strategic, corporate venture capital arm of Merck. There have been dramatic improvements in omics technologies – that is the collective technologies used to explore molecular behaviour, such as genomics, proteomics, metabolomics, metagenomics and transcriptomics. And this is enabling scientists to analyze potential drug targets more efficiently in terms of their potential impact on a pathogen or disease. But there is no automated solution that harnesses all preclinical data in a way that allows for a reliable assessment of the clinical trial readiness of a new drug candidate. Now, some pharma and research initiatives are hoping to change that, among them AION Labs. Together with its German partner BioMed X, the Israeli-based research alliance, hosted 15 teams of computational biologists, AI researchers and biomedical scientists for a ‘boot camp’ that aims to speed up the drug discovery process and lower costs – harnessing AI technologies in novel ways. Mission: identify critical safety issues before expensive clinical trial stage The latest boot camp cohort The teams were charged with making a proposal for the development of a versatile, next-generation computational platform that can identify hidden safety liability and lack of efficacy, and close identified gaps in the drug candidate pre-clinical data package. “The big problem in drug discovery and development is that after a lot of experiments have been done and we have a new drug candidate, many of these candidates fail in very expensive clinical trials in humans,” Dr. Christian Tidona, founder and managing director of the BioMed X Institute told Health Policy Watch. “That’s because humans are different from mice or a dish in the lab.” The challenge is that pharma companies usually only discover that a drug candidate either is not safe or will not work after years of effort and hundreds of millions of dollars of investment. Companies can invest $5 billion and 12-years’ time, on average, Tidona said, to create the next “blockbuster drug.” “When one thinks about these numbers, he can imagine why some of these drugs are so expensive. Could an AI platform predict if a drug is really ready for the clinic and, if not, tell us what was missed before we go to trial?” Tidona asked. “This is the question. “If drugs can be made more efficiently, medicines can become cheaper and more people in all parts of the world could afford them,” he said. Solving therapeutic challenges Kahina Lang, head of Strategic Innovation at Merck Group, addresses the candidates at the AION Labs boot camp. Based in Rehovot, not far from the the famed Weizmann Institute, AION brings together some of the biggest names in pharma, including AstraZeneca, Merck, Pfizer, and Teva, with young biotech inventors and entrepreneurs, to crack biomedical research challenges together and in a novel way. “We work with each of our pharma partners separately and then together to identify the top research challenges that solving would be majorly impactful for the industry at large,” AION CEO Mati Gill told Health Policy Watch. Then, AION looks for innovators and scientists to develop solutions for them. For last week’s boot camp, 15 applicants from around the world were selected to come to Israel and participate. “The winner receives a $2 million investment, mentorship and access to a wealth of data for model training from these four big pharma companies,” Tidona said. “It is more or less paradise for anyone who wants to start a company.” The concept is based on a model Tidona first developed on the campus of the University of Heidelberg in Germany, with a world-wide network of partner locations. If the company succeeds, the technology belongs to it but will be made available for purchase by the pharma partners. ‘Bringing the promise of AI to fruition’ Guy Spigelman of AWS addresses candidates at the AION Labs bootcamp. Merck’s Yerushalmi said that there have been “all kinds of efforts to make the drug development model more efficient – to expedite it,” but until now it has not worked. When computational approaches to research were first introduced, “it brought a lot of promise, but until now it has not brought as much fruit as we hoped. Now, with AI tools and the amount of data pharma and other companies can generate, we do hope we may be able to bring this promise to fruition.” AI is one of the most sophisticated computational tools. AI analysis has brought “ingenious” solutions to other fields, like the automotive industry, she pointed out. “AI tools and big data have proven themselves in so many other cases, I think it will probably work for our industry too,” Yerushalmi said. “Want to make [drug development] more affordable and shorter, so we can bring drugs to the market faster and cheaper for the benefit of humanity.” Finding the most effective antibodies AION will be looking for the next therapeutic antibodies. This most recent boot camp was AION’s second one so far. Earlier this year, it invited computational biologists and biomedical scientists to propose ideas for discovering therapeutic antibodies. “Advances in protein structure prediction, artificial intelligence algorithms, and increased availability of experimentally determined antigen-antibody structures present a unique opportunity for AI-driven antibody discovery,” AION said in a release. In the coming months, it will hold a third boot camp at which computational biologists, bioinformatics and cheminformatics scientists and AI researchers will propose ideas for the development of a next-generation computational platform to optimize antibodies for targeted therapies with enhanced properties, including developability or manufacturability, stability, aggregation, immunogenicity, pharmacokinetics and tissue distribution. “The ultimate solution is an AI platform that receives sequences of binders and generates novel variants with optimized IgG sequences, biophysical and targeting properties,” a background briefing explained. “The goal of the AI algorithm is to make an existing antibody a better drug while reducing design iterations, optimization of cycle times and lowering attrition rates.” CEPI launches AI-based quest for beta-coronavirus vaccine candidate The AION initiative, while pioneering in the use of AI for drug discovery, is not the only one. On Thursday, the Oslo-based Coalition for Epidemic Preparedness (CEPI) announced that it would provide seed funding of up to US $4.8 million to a consortium to support the AI-based development of betacoronavirus vaccine candidates – the new holy grail for coronavirus vaccines. The research consortium, led by a Norway-based subsidiary of the Japanese NEC Group, which specializes in AI technologies, also includes the European Vaccine Initiative (EVI) and Oslo University Hospital. It aims to establish preclinical proof of concept for an mRNA-based vaccine that protects against a broad range of beta coronaviruses – rather than SARS-CoV2 alone, said CEPI in a press release. NEC will apply its experience in the AI design of immunogens to identify novel vaccine antigens with broad reactivity against beta-coronaviruses. The lead antigens will be selected iteratively and validated in preclinical studies against known beta coronaviruses that already pose a significant epidemic or pandemic risk, such as SARS-CoV, SARS-CoV-2 and MERS-CoV. If the approach is successful, it may also be applicable for developing vaccines against other pathogens in the CEPI portfolio, including ‘Disease X’ – unknown pathogens with pandemic potential that have yet to emerge. What the future holds What the future of AI holds. Tidona, for his part, hopes that AION will spin off 20 new start-ups in the next four to six years. “We are building an innovation ecosystem,” he said, noting that it is attractive to host countries as it provides a draw for youthful talent, which in turn spurs economic development. He added that if the model works well, BioMed X plans to export it to other countries as well. “The focus now is on Israel as our first partner outside Germany,” Tidona said. “But in the future, we hope to have sites” in other places, too. Image Credits: https://www.flickr.com/photos/mikemacmarketing/42271822770/, AION Labs, Elad Malka, Twitter: @WHO, https://www.flickr.com/photos/158301585@N08/43267970922/. Global Health Leaders Call on African Policymakers To Do More to Stop Climate Change 08/04/2022 Paul Adepoju WHO argues that climate-smart initiatives are good for health. But the health sector receives less than 1% of international climate finance, said Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC). Global health leaders have repeatedly called for stepped up investments to both slow down climate change and recognize the health co-benefits of more climate action. But political leaders, including those in low and middle-income countries, still need to do more, Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC) told Health Policy Watch in a briefing on Thursday, World Health Day. Meanwhile, WHO’s Regional Director for Africa, Matshidiso Moeti, enjoined African governments to “prioritize human wellbeing in every strategy and decision,” including halting fossil fuel expansion that ultimately will boomerang on the countries concerned. “I’d like to take this opportunity to call on an African governments to prioritize human wellbeing in every strategy and decision to halt new fossil fuel exploration and subsidies, institute taxes for polluting firms and to implement the WHO air quality guidelines for example,” said Moeti, speaking on this year’s World Health Day theme, ‘Our Planet, Our Health.’ Added Cissé, countries that harness more of their own national and local policies, innovations and resources can make a difference. “Countries can go for some financial incentive policy at a national scale that includes taxes and subsidies; they can also have some innovative policies regarding insurance. They can also give some small scale financial products to low income and other households,” Cissé said. Support to health sector less than 1% of international climate finance Experts are increasingly aware of the multi-faced impacts of the climate crisis on health – as well and the increased precarity of health in the face of deforestation and biodiversity loss as well as unhealthy foods production – which are also driving climate change. So far, however, support to the health sector for climate action still comprises less than 1% of international climate finance investments, Cissé said, speaking at a WHO African Region World Health Day briefing. Health co-benefits of climate mitigation strategies – for instance fewer air pollution-related deaths from cleaner energy investments, also go uncounted in climate strategies. This, despite health being mentioned as a priority in 54% of countries’ Nationally Determined Contributions (NDCs), which are the main instruments now being used for global climate pledges to reduce harmful emissions, under the UN Framework Convention on Climate Change. Cissé who works with the Swiss Tropical and Public Health Institute at the University of Basel in Switzerland, noted that this reflects the low priority still being given to climate change in the context of health. World Health Day at a time of heightened conflict and fragility Joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra (center) and WHO Director-General Dr Tedros Adhanom Ghebreyesus (right) This year’s World Health Day, which marks the April 7, 1948 date of WHO’s founding, comes at a time of both heightened political conflict and greater ecosystem fragility, noted WHO Director-General Dr Tedros Adhanom Ghebreyesus. He was speaking at a joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra. “The pandemic has highlighted the intimate links between the health of humans, animals and the environment. And yet, we’re rapidly making the planet on which all life depends and inhabitable… “The climate crisis is a health crisis,” Tedros said at the Thursday briefing, which concluded a series of face-to-face meetings this week with US Administration officials – the first since President Joe Biden’s inauguration last year. ”Air pollution kills 7 million people every year. And 99% of the world’s population breathes unhealthy air mainly as a result of burning fossil fuels,” Tedros added. (see related story) “Our warming world is facilitating the spread of mosquitoes and diseases they carry. Extreme weather events, biodiversity loss, land degradation, and water scarcity are displacing people and damaging their health,” Tedros said. “Systems that produce highly processed, unhealthy foods are driving a wave of obesity, increasing cancer and heart disease, and generating one-third of greenhouse gas emissions. “As the world recovers from the pandemic we have a choice: we can go back to the way things were or we can change course. We can create societies, economies and products that nurture health and well being, and stop subsidizing those that destroy – because we cannot afford to pump carbon into the atmosphere at the same rate, and still breathe clean air. “We cannot afford the same patterns of consumption and expect less diabetes, hypertension, heart disease and cancer. We must choose. We cannot afford ever-deepening inequalities and expect continued prosperity. We must choose.” Half new fossil fuel exploration and subsidies, prioritize health, says WHO Regional Director Water shortage in Ethiopia. Population exposure to heat is increasing due to climate change. Globally, extreme temperature events are observed to be increasing in their frequency, duration, and magnitude. In Africa, one of the regions of the world that is worst affected by climate change, extreme weather events are having ever greater impacts on food security, water access, and related to that, nutrition and disease transmission. Of the more than 2000 public health events recorded in the African region between 2019 and 2020, more than half were climate-related, said Moeti, speaking from WHO’s Regional Office in Brazzaville. This, she said, represented a 25% increase compared with the previous decade. “In Africa, diarrhoeal diseases are the third leading cause of death and illness in children younger than five, which could be preventable with safe drinking water, adequate sanitation and hygiene, and installation,” Moeti said. “Our analysis showed that waterborne diseases, mainly due to cholera outbreaks, accounted for 40% of climate-related health emergencies in the past 20 years.” In urging African governments to adopt cleaner, healthier policies, she said the main motive is really self-preservation. “Älthough Africa contributes the least to global warming, the continent bears a disproportionate burden of the consequences,” said Moeti. “It’s up to every one of us to promote and support multi-sectoral interventions that address the threat of climate change, while helping to better prepare for future health shocks like the COVID-19 pandemic.” Image Credits: Oxfam East Africa. 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.
Historic Public Hearings on WHO Pandemic Instrument; Some Unhappiness with Process 12/04/2022 Kerry Cullinan The last Ebola patient leaves a treatment centre in the Democratic Republic of Congo at the end of March 2021, marking the countdown to declaring the end of that pandemic. The World Health Organization (WHO) convened public hearings for only the second time in its history on Tuesday, asking interested parties what substantive issues should be contained in its proposed international instrument on pandemic preparedness and response. The first and only other WHO hearings were held 22 years ago in the run-up to the adoption of the Framework Convention on Tobacco Control, according to WHO principal legal officer Steven Solomon. Welcoming the public hearing, WHO Director-General Dr Tedros Adhanom Ghebreyesus said that informed opinion and active public cooperation are of the utmost importance to improve health, and it was important to learn from the COVID-19 pandemic to ensure the world is “better prepared” for the next pandemic. Tedros had been mandated by last year’s World Health Assembly Special Session to convene public hearings to inform the work of the Intergovernmental Negotiating Body (INB) which is in charge of negotiating the pandemic instrument or treaty. INB co-chair, South Africa’s Dr Precious Matsoso, described the hearings as “remarkable” and “historic”. Dr Precious Matsoso, INB co-chair Narrow responsibility However, the Civil Society Alliance for Human Rights in the Pandemic Treaty warned that the consultative process risks being “inadequate”. “While this week’s public hearings reflect the INB’s stated objective to consult the public to some extent, it has interpreted its responsibility to do so very narrowly,” according to the alliance. “The INB has allocated minimal time to engaging with the wide range of stakeholders who could inform the process and improve both the legitimacy and quality of the Treaty that emerges.” Dr Meg Davis, from the Global Health Centre at the Graduate Institute in Geneva, also said that participants had been given no indication of whether or how their submissions would be included in the negotiations and recommended policymaking models to ensure meaningful civil society engagement. A number of organisations gave two-minute speeches focusing on a wide range of issues including ‘One Health’, research and development (R&D) and intellectual property rights at the hearings, which continue on Wednesday and then reconvene in mid-June. Equity means sharing Research and Development Professor Suerie Moon, co-director of the Global Health Centre at the Graduate Institute in Geneva. All member states have committed to equity at the heart of any pandemic instrument, but Professor Suerie Moon, co-director of the Geneva Graduate Institute’s Global Health Centre, told the hearings that “equity requires collective research and development of vaccines, drugs and diagnostics”. Pointing out that COVID-19 has led to the development of technology transfer hubs in South Africa and the Republic of Korea, Moon warned that “there’s a risk that new factories will sit idle in the next emergency unless the new international instrument forges agreement on obligations to share knowledge, data and intellectual property before and during future emergencies”. “It’s unlikely, however, that countries or companies will do so out of the goodness of their hearts,” added Moon. “To make such sharing feasible, we have to tie it to commitments to jointly finance research and development to share pathogen samples and genomic sequencing data. In other words, the key idea is collective research and development for collective benefit.” Acknowledging that intellectual property was a difficult issue, Moon nonetheless said that if equitable access was to become a reality “the new instrument must include the nuts-and-bolts provisions to make sharing technology for pandemics the new normal”. To address IP, Knowledge Ecology International (KEI) recommended that governments should “agree to collectively use exceptions to intellectual property rights that are permitted in existing trade agreements and treaties”. “A model for this is the WIPO Marrakesh Treaty for the Blind, which mandates its members to use exceptions in copyrights to enhance global access to works made accessible to persons who are blind or have other disabilities,” according to KEI’s James Love. KEI also proposed “a robust chapter on transparency”, adding that “the lack of transparency in many areas for the current pandemic is an appalling and unnecessary policy failure, and one that both makes it more difficult to manage a pandemic response, and undermines the public’s trust in institutions”. Rachael Crockett from the Drugs for Neglected Diseases initiative (DNDi) stressed the need to co-ordinate R&D as a substantive element of the new instrument. DNDi wants R&D priority setting, and “globally agreed norms and binding rules that govern the R&D process, including transparency and open sharing of research, data, knowledge, technology, and equitable allocation of health tools”. Sharing pathogens IFPMA’s Grega Kumer Grega Kumer from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) said “any system should be built on what worked well during the COVID pandemic, in particular, immediate sharing of pathogens and a robust response from the IP based private sector”. The IFPMA presented eight core principles, including that the negotiation process should be “inclusive and transparent, involving the private sector and all critical contributors to pandemic preparedness efforts”. “Any system should allow for immediate access of pathogens and genetic sequence data and correct the negative effects of access and benefit-sharing legislation,” said Kumer. The IFPMA also supports more equitable access to tests, treatments and vaccines “based on medical need, thus enhancing solidarity and facilitating emergency financing to institutions procuring for developing countries”, and the protection of supply chains ”from arbitrary export restrictions and other trade barriers”. “While the public sector might play a larger role in pandemic setting, the system should build on the private sector strengths for R&D, manufacturing and distribution,” he concluded. One Health is key The need for any pandemic instrument to adopt a One Health approach also emerged as a key theme. Dame Sally Davies, speaking for the UN Global Leaders Group on Antimicrobial Resistance (AMR), said that they wanted AMR to be integrated alongside a primary focus on pandemics. “The next pandemic could be drug-resistant, or could depend on antimicrobials to mitigate it,” said Davies, saying that one health surveillance needed to be at the heart of any pandemic treaty to enable “rapid, transparent and responsive protection”. Governance principles The Panel for a Global Health Convention believes the instrument must be governed by four non-negotiable principles, according to Dame Barbara Stocking. “Solidarity, because we’re all in this together, and solidarity is in our own self-interest,” explained Stocking. “Equity: there must be equal access to vaccines and treatments, but also an equal voice in decision-making. Transparency in reporting data and samples. Accountability, as the lack of accountability of countries is the fundamental reason that we are in disarray.” The hearings continue at 8am CET on Wednesday and can be followed live. Image Credits: WHO African Region. Nineteen More Attacks on Ukraine’s Health Facilities Since Friday: WHO 11/04/2022 Kerry Cullinan Ukraine operating theatre destroyed The World Health Organization (WHO) has verified 108 attacks on health care in Ukraine as of Monday in which 73 people have died and 51 have been injured. That is 19 more attacks on health facilities than the already deadly toll of 91 attacks that had been verified by WHO as of early Friday afternoon, and as reported at a press conference by WHO’s Regional Director Hans Kluge in Lviv. .@WHO has verified 5 additional reports of attacks on health care in #Ukraine. As of 11 April, 108 attacks on health care in Ukraine have been verified, causing 73 deaths and 51 injuries. We are outraged that attacks on health care are continuing. pic.twitter.com/8GNUQZFiK9 — WHO Ukraine (@WHOUkraine) April 11, 2022 Meanwhile, the Office of the UN High Commissioner for Human Rights (OHCHR) has recorded 1,793 civilian deaths and 2,439 injuries since the start of the Russian invasion on 24 February and Sunday. Most of the civilian casualties have been caused by “explosive weapons with a wide impact area”, including shelling from heavy artillery and rocket, missile and air strikes. https://data.humdata.org/visualization/ukraine-humanitarian-operations/ “OHCHR believes that the actual figures are considerably higher, as the receipt of information from some locations where intense hostilities have been going on has been delayed and many reports are still pending corroboration,” according to a statement from the office. “This concerns, for example, Mariupol (Donetsk region), Izium (Kharkiv region), Popasna (Luhansk region), and Borodianka (Kyiv region), where there are allegations of numerous civilian casualties. These figures are being further corroborated and are not included in the above statistics.” According to the Prosecutor General’s Office of Ukraine, 176 children had been killed and at least 336 injured as of Sunday. Image Credits: WHO. Pfizer Refuses Cooperation with DNDi on Study of Paxlovid Treatment Adapted to Low Income Countries 08/04/2022 Elaine Ruth Fletcher & Kerry Cullinan Paxlovid Pfizer has so far refused an invitation from the Geneva-based Drugs for Neglected Diseases Initiative (DNDi) to cooperate on a study exploring whether the treatment window of its successful antiviral drug, Paxlovid, could be extended from 5-7 days using another drug compound in addition, Dr Nathalie Strub-Wourgaft, Director of DNDi’s COVID-19 Response, told Health Policy Watch. DNDi wants to test if the key active ingredient of Paxlovid, nirmatrelvir, could be offered in combination with an inhaled corticosteroid, budesonide, in order to extend the treatment window of the life-saving COVID treatment by two more days, Strub-Wourgaft said in an interview. Extending the treatment window is critical for patients in low-income countries because the currently-approved formulation of Paxlovid must be commenced within 3-5 days of COVID symptoms. Meanwhile ANTICOV, a major DNDi-sponsored trial of COVID treatments underway in ten African countries, has revealed that one-half of COVID patients present for treatment after the five day cut-off date. ANTICOV clinical trial. That makes the current Paxlovid combination less than suitable for low- and middle-income country (LMIC) conditions, said Strub-Wourgaft. She is one of the coordinators of the ANTICOV Consortium, a group of 26 African and global research organizations engaged in the clinical trial research on novel COVID drugs for LMICs. On 15 March, DNDi issued a public statement expressing its concern that “efforts to conduct urgently needed studies in low- and middle-income countries (LMICs) utilizing the novel oral antiviral, nirmatrelvir/ritonavir (Paxlovid), are being blocked by Pfizer, which developed the drug. Paxlovid, which uses the common HIV drug ritonavir in combination with nirmatrelvir, has been found to reduce the risk of hospitalization or death by a stunning 89% in patients at high risk of severe COVID-19 disease. But the treatment needs to be taken within three to five days of patients developing symptoms. According to DNDi, “an interim analysis done in the context of the ongoing ANTICOV clinical trial conducted in 10 African countries showed that of the 1180 patients enrolled, more than half present for care after day 5. “To overcome this challenge, it is necessary to explore whether using Paxlovid with other drugs could widen the ‘treatment window’ to at least seven days,” DNDi said in its statement. DNDi also wants to investigate if the drug could be “beneficial for immune-suppressed patients who are the most vulnerable to disease progression but were excluded from phase 3 trials.” DNDi, a Geneva-based not-for-profit research and development organisation, works to deliver new treatments on neglected diseases and serving neglected groups in low- and middle-income countries. Still looking for ways to access nirmatrelvir DNDi drug development. Strub, in her comments to Health Policy Watch, suggested that DNDi, which has a good track record of building cooperation with the pharma industry, was still trying to obtain the drug somehow – or even persuade Pfizer to collaborate. “We would like to test nirmatrelvir/ritonavir in combination, as well, with inhaled budesonide or maybe fluoxetine (brand name Prozac),” said Strub-Wourgaft. “We issued a statement to say that we had asked Pfizer to get access to nirmatrelvir, to work with us on this trial. They denied. We’re continuing to try to get access to this drug.” “We think this [combination] would extend the window of treatment to seven days of symptoms. In the study that they [Pfizer] have done, which is a great study showing really fantastic results, they looked at patients who had five days of symptoms before they were enrolled. “And we have seen for now, in our study in Africa, that half of the patients come after five days of symptoms,” she said. Such delays are typical because COVID diagnosis and treatment services are less widely available and it thus takes people longer to get diagnosed, even if they are symptomatically ill. “There are critically important public health research questions that must be answered quickly – particularly in low- and middle-income countries where access to vaccines remains low,” added Strub-Wourgaft, in the DNDi statement. “It is difficult to understand any rationale for refusing to cooperate in the midst of a global pandemic, and this sets a dangerous precedent since there are many other promising antivirals in the pipeline and these novel treatments will also require follow-on research to determine their optimal use in resource-limited settings.” MPP deal with Pfizer – not enough Pfizer recently signed a deal with another Geneva-based group, the non-profit Medicines Patent Pool, that will allow 35 new manufacturers to produce and supply generic versions of Paxlovid to some 95 low- and middle income countries – in what the company has said is a move to lower the drug’s cost and expand access in low-income countries. But that deal has also been criticised for failing to cover dozens of other middle-income and upper-middle income countries that will have to purchase patented versions of the drug. Although Pfizer had also said that it would create a tiered pricing system for Paxlovid, drug price advocates say that the price remains too high in many settings. In the United States, the government pays Pfizer about $530 for a five day course, although the pills also are in short supply in some US communities. In addition, most of Pfizer’s Paxlovid supply for the first half of 2022 has already been bought up by rich countries, meaning that LMICs will only be able to get about 10 million doses of the drug in the near term. Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates However, even considering the MPP deal and other preferential pricing mechanisms, the fact remains that the version of Paxlovid currently being produced is not an optimal fit for many LMICs, Strub-Wourgaft said. “So for now, if we were to be able to give them Paxlovid, under the current conditions, half of them would not even have access,” she told Health Policy Watch. MPP deals with generic manufacturers may not enable supplies to ANTICOV DNDi is also concerned about the potential difficulty of obtaining generic versions of Paxlovid to conduct the new ANTICOV combination studies, the company has said. “The terms of the Pfizer/Medicines Patent Pool (MPP) licensing agreement to the new generics manufacturers could be interpreted to mean that sub-licensees cannot provide nirmatrelvir/ritonavir for use in the sorts of combination studies that DNDi and others wish to conduct, unless they have explicit written approval from Pfizer. “Some generic manufacturers are also encountering difficulties obtaining Paxlovid as a ‘reference drug’ so that they can conduct the necessary bioequivalence studies to show regulators that their generic version has the same effect in the body, effectively blocking availability of generics for both research and clinical use”, DNDi added in its statement. It has therefore asked Pfizer to not only provide access to nirmatrelvir/ritonavir (Paxlovid) for the DNDi-coordinated ANTICOV trial and other relevant clinical trials, but also to: Remove any ambiguities or restrictions in the Pfizer-MPP licensing agreement that could prevent sub-licensees from supplying such research studies (or publicly clarify that no such restrictions exist); Provide access to Pfizer’s originator product as a ‘reference drug’ so that any interested generic manufacturer can conduct the necessary bioequivalence studies for regulatory approval; and Allocate sufficient quantities of Paxlovid specifically for LMICs and remove all barriers to access to generic nirmatrelvir/ritonavir to enable scale up for care and treatment in LMICs. “Every effort should be made to ensure that clinical studies for COVID-19 treatment are conducted in low- and middle-income countries, and that any products developed reach vulnerable populations,” said Dr John Amuasi, head of the Global Health and Infectious Diseases Research Grou at Kumasi Center for Collaborative Research in Tropical Medicine in Ghana and a principal investigator for ANTICOV. “We must not arrive at a situation where research priorities are determined by the actions or inactions of any company.” Pfizer response – committed to well-controlled trials In response to a request from Health Policy Watch, a Pfizer spokesperson did not provide any clarification of the reasons behind the company’s refusal to participate in the DNDi trial – aimed a making the treatment more suitable to low-income settings. “Pfizer appreciates the importance of gathering additional data and information for governments to help maximize the public health response to the COVID-19 pandemic,” said the spokesperson, adding that the company is committed to “well-controlled, hypothesis-driven clinical studies that can provide data that will be accepted by global regulatory agencies. “Additional studies of PAXLOVID are underway or are being explored, and we will continue to share information as we have it,” the spokesperson added. In addition, “Right now, we are focusing our efforts and resources in a way that maximizes availability of our overall supply, to help ensure access to patients as quickly as possible,” the spokesperson said, noting that the company remains “confident” in the clinical trial results, which showed an 88-89% efficacy rate for the drug, when it was administered to non-hospitalized, high-risk patients within 3-5 days of symptom onset. -Updated 9 April with correction on the price of Paxlovid paid by the US government for patients in the USA and on 11 April with details of Pfizer response. Image Credits: Bobbi-Jean MacKinnon, DNDI/Twitter, DNDi. Artificial Intelligence ‘Boot Camp’ Aims to Accelerate Drug Discovery 08/04/2022 Maayan Hoffman Machine learning is playing an increasingly important role in computing and artificial intelligence. TEL AVIV – Ninety percent of drug candidates fail in clinical trials because of unexpected safety issues or lack of efficacy in human subjects, according to Noga Yerushalmi, Investment Director at M Ventures, the strategic, corporate venture capital arm of Merck. There have been dramatic improvements in omics technologies – that is the collective technologies used to explore molecular behaviour, such as genomics, proteomics, metabolomics, metagenomics and transcriptomics. And this is enabling scientists to analyze potential drug targets more efficiently in terms of their potential impact on a pathogen or disease. But there is no automated solution that harnesses all preclinical data in a way that allows for a reliable assessment of the clinical trial readiness of a new drug candidate. Now, some pharma and research initiatives are hoping to change that, among them AION Labs. Together with its German partner BioMed X, the Israeli-based research alliance, hosted 15 teams of computational biologists, AI researchers and biomedical scientists for a ‘boot camp’ that aims to speed up the drug discovery process and lower costs – harnessing AI technologies in novel ways. Mission: identify critical safety issues before expensive clinical trial stage The latest boot camp cohort The teams were charged with making a proposal for the development of a versatile, next-generation computational platform that can identify hidden safety liability and lack of efficacy, and close identified gaps in the drug candidate pre-clinical data package. “The big problem in drug discovery and development is that after a lot of experiments have been done and we have a new drug candidate, many of these candidates fail in very expensive clinical trials in humans,” Dr. Christian Tidona, founder and managing director of the BioMed X Institute told Health Policy Watch. “That’s because humans are different from mice or a dish in the lab.” The challenge is that pharma companies usually only discover that a drug candidate either is not safe or will not work after years of effort and hundreds of millions of dollars of investment. Companies can invest $5 billion and 12-years’ time, on average, Tidona said, to create the next “blockbuster drug.” “When one thinks about these numbers, he can imagine why some of these drugs are so expensive. Could an AI platform predict if a drug is really ready for the clinic and, if not, tell us what was missed before we go to trial?” Tidona asked. “This is the question. “If drugs can be made more efficiently, medicines can become cheaper and more people in all parts of the world could afford them,” he said. Solving therapeutic challenges Kahina Lang, head of Strategic Innovation at Merck Group, addresses the candidates at the AION Labs boot camp. Based in Rehovot, not far from the the famed Weizmann Institute, AION brings together some of the biggest names in pharma, including AstraZeneca, Merck, Pfizer, and Teva, with young biotech inventors and entrepreneurs, to crack biomedical research challenges together and in a novel way. “We work with each of our pharma partners separately and then together to identify the top research challenges that solving would be majorly impactful for the industry at large,” AION CEO Mati Gill told Health Policy Watch. Then, AION looks for innovators and scientists to develop solutions for them. For last week’s boot camp, 15 applicants from around the world were selected to come to Israel and participate. “The winner receives a $2 million investment, mentorship and access to a wealth of data for model training from these four big pharma companies,” Tidona said. “It is more or less paradise for anyone who wants to start a company.” The concept is based on a model Tidona first developed on the campus of the University of Heidelberg in Germany, with a world-wide network of partner locations. If the company succeeds, the technology belongs to it but will be made available for purchase by the pharma partners. ‘Bringing the promise of AI to fruition’ Guy Spigelman of AWS addresses candidates at the AION Labs bootcamp. Merck’s Yerushalmi said that there have been “all kinds of efforts to make the drug development model more efficient – to expedite it,” but until now it has not worked. When computational approaches to research were first introduced, “it brought a lot of promise, but until now it has not brought as much fruit as we hoped. Now, with AI tools and the amount of data pharma and other companies can generate, we do hope we may be able to bring this promise to fruition.” AI is one of the most sophisticated computational tools. AI analysis has brought “ingenious” solutions to other fields, like the automotive industry, she pointed out. “AI tools and big data have proven themselves in so many other cases, I think it will probably work for our industry too,” Yerushalmi said. “Want to make [drug development] more affordable and shorter, so we can bring drugs to the market faster and cheaper for the benefit of humanity.” Finding the most effective antibodies AION will be looking for the next therapeutic antibodies. This most recent boot camp was AION’s second one so far. Earlier this year, it invited computational biologists and biomedical scientists to propose ideas for discovering therapeutic antibodies. “Advances in protein structure prediction, artificial intelligence algorithms, and increased availability of experimentally determined antigen-antibody structures present a unique opportunity for AI-driven antibody discovery,” AION said in a release. In the coming months, it will hold a third boot camp at which computational biologists, bioinformatics and cheminformatics scientists and AI researchers will propose ideas for the development of a next-generation computational platform to optimize antibodies for targeted therapies with enhanced properties, including developability or manufacturability, stability, aggregation, immunogenicity, pharmacokinetics and tissue distribution. “The ultimate solution is an AI platform that receives sequences of binders and generates novel variants with optimized IgG sequences, biophysical and targeting properties,” a background briefing explained. “The goal of the AI algorithm is to make an existing antibody a better drug while reducing design iterations, optimization of cycle times and lowering attrition rates.” CEPI launches AI-based quest for beta-coronavirus vaccine candidate The AION initiative, while pioneering in the use of AI for drug discovery, is not the only one. On Thursday, the Oslo-based Coalition for Epidemic Preparedness (CEPI) announced that it would provide seed funding of up to US $4.8 million to a consortium to support the AI-based development of betacoronavirus vaccine candidates – the new holy grail for coronavirus vaccines. The research consortium, led by a Norway-based subsidiary of the Japanese NEC Group, which specializes in AI technologies, also includes the European Vaccine Initiative (EVI) and Oslo University Hospital. It aims to establish preclinical proof of concept for an mRNA-based vaccine that protects against a broad range of beta coronaviruses – rather than SARS-CoV2 alone, said CEPI in a press release. NEC will apply its experience in the AI design of immunogens to identify novel vaccine antigens with broad reactivity against beta-coronaviruses. The lead antigens will be selected iteratively and validated in preclinical studies against known beta coronaviruses that already pose a significant epidemic or pandemic risk, such as SARS-CoV, SARS-CoV-2 and MERS-CoV. If the approach is successful, it may also be applicable for developing vaccines against other pathogens in the CEPI portfolio, including ‘Disease X’ – unknown pathogens with pandemic potential that have yet to emerge. What the future holds What the future of AI holds. Tidona, for his part, hopes that AION will spin off 20 new start-ups in the next four to six years. “We are building an innovation ecosystem,” he said, noting that it is attractive to host countries as it provides a draw for youthful talent, which in turn spurs economic development. He added that if the model works well, BioMed X plans to export it to other countries as well. “The focus now is on Israel as our first partner outside Germany,” Tidona said. “But in the future, we hope to have sites” in other places, too. Image Credits: https://www.flickr.com/photos/mikemacmarketing/42271822770/, AION Labs, Elad Malka, Twitter: @WHO, https://www.flickr.com/photos/158301585@N08/43267970922/. Global Health Leaders Call on African Policymakers To Do More to Stop Climate Change 08/04/2022 Paul Adepoju WHO argues that climate-smart initiatives are good for health. But the health sector receives less than 1% of international climate finance, said Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC). Global health leaders have repeatedly called for stepped up investments to both slow down climate change and recognize the health co-benefits of more climate action. But political leaders, including those in low and middle-income countries, still need to do more, Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC) told Health Policy Watch in a briefing on Thursday, World Health Day. Meanwhile, WHO’s Regional Director for Africa, Matshidiso Moeti, enjoined African governments to “prioritize human wellbeing in every strategy and decision,” including halting fossil fuel expansion that ultimately will boomerang on the countries concerned. “I’d like to take this opportunity to call on an African governments to prioritize human wellbeing in every strategy and decision to halt new fossil fuel exploration and subsidies, institute taxes for polluting firms and to implement the WHO air quality guidelines for example,” said Moeti, speaking on this year’s World Health Day theme, ‘Our Planet, Our Health.’ Added Cissé, countries that harness more of their own national and local policies, innovations and resources can make a difference. “Countries can go for some financial incentive policy at a national scale that includes taxes and subsidies; they can also have some innovative policies regarding insurance. They can also give some small scale financial products to low income and other households,” Cissé said. Support to health sector less than 1% of international climate finance Experts are increasingly aware of the multi-faced impacts of the climate crisis on health – as well and the increased precarity of health in the face of deforestation and biodiversity loss as well as unhealthy foods production – which are also driving climate change. So far, however, support to the health sector for climate action still comprises less than 1% of international climate finance investments, Cissé said, speaking at a WHO African Region World Health Day briefing. Health co-benefits of climate mitigation strategies – for instance fewer air pollution-related deaths from cleaner energy investments, also go uncounted in climate strategies. This, despite health being mentioned as a priority in 54% of countries’ Nationally Determined Contributions (NDCs), which are the main instruments now being used for global climate pledges to reduce harmful emissions, under the UN Framework Convention on Climate Change. Cissé who works with the Swiss Tropical and Public Health Institute at the University of Basel in Switzerland, noted that this reflects the low priority still being given to climate change in the context of health. World Health Day at a time of heightened conflict and fragility Joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra (center) and WHO Director-General Dr Tedros Adhanom Ghebreyesus (right) This year’s World Health Day, which marks the April 7, 1948 date of WHO’s founding, comes at a time of both heightened political conflict and greater ecosystem fragility, noted WHO Director-General Dr Tedros Adhanom Ghebreyesus. He was speaking at a joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra. “The pandemic has highlighted the intimate links between the health of humans, animals and the environment. And yet, we’re rapidly making the planet on which all life depends and inhabitable… “The climate crisis is a health crisis,” Tedros said at the Thursday briefing, which concluded a series of face-to-face meetings this week with US Administration officials – the first since President Joe Biden’s inauguration last year. ”Air pollution kills 7 million people every year. And 99% of the world’s population breathes unhealthy air mainly as a result of burning fossil fuels,” Tedros added. (see related story) “Our warming world is facilitating the spread of mosquitoes and diseases they carry. Extreme weather events, biodiversity loss, land degradation, and water scarcity are displacing people and damaging their health,” Tedros said. “Systems that produce highly processed, unhealthy foods are driving a wave of obesity, increasing cancer and heart disease, and generating one-third of greenhouse gas emissions. “As the world recovers from the pandemic we have a choice: we can go back to the way things were or we can change course. We can create societies, economies and products that nurture health and well being, and stop subsidizing those that destroy – because we cannot afford to pump carbon into the atmosphere at the same rate, and still breathe clean air. “We cannot afford the same patterns of consumption and expect less diabetes, hypertension, heart disease and cancer. We must choose. We cannot afford ever-deepening inequalities and expect continued prosperity. We must choose.” Half new fossil fuel exploration and subsidies, prioritize health, says WHO Regional Director Water shortage in Ethiopia. Population exposure to heat is increasing due to climate change. Globally, extreme temperature events are observed to be increasing in their frequency, duration, and magnitude. In Africa, one of the regions of the world that is worst affected by climate change, extreme weather events are having ever greater impacts on food security, water access, and related to that, nutrition and disease transmission. Of the more than 2000 public health events recorded in the African region between 2019 and 2020, more than half were climate-related, said Moeti, speaking from WHO’s Regional Office in Brazzaville. This, she said, represented a 25% increase compared with the previous decade. “In Africa, diarrhoeal diseases are the third leading cause of death and illness in children younger than five, which could be preventable with safe drinking water, adequate sanitation and hygiene, and installation,” Moeti said. “Our analysis showed that waterborne diseases, mainly due to cholera outbreaks, accounted for 40% of climate-related health emergencies in the past 20 years.” In urging African governments to adopt cleaner, healthier policies, she said the main motive is really self-preservation. “Älthough Africa contributes the least to global warming, the continent bears a disproportionate burden of the consequences,” said Moeti. “It’s up to every one of us to promote and support multi-sectoral interventions that address the threat of climate change, while helping to better prepare for future health shocks like the COVID-19 pandemic.” Image Credits: Oxfam East Africa. 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.
Nineteen More Attacks on Ukraine’s Health Facilities Since Friday: WHO 11/04/2022 Kerry Cullinan Ukraine operating theatre destroyed The World Health Organization (WHO) has verified 108 attacks on health care in Ukraine as of Monday in which 73 people have died and 51 have been injured. That is 19 more attacks on health facilities than the already deadly toll of 91 attacks that had been verified by WHO as of early Friday afternoon, and as reported at a press conference by WHO’s Regional Director Hans Kluge in Lviv. .@WHO has verified 5 additional reports of attacks on health care in #Ukraine. As of 11 April, 108 attacks on health care in Ukraine have been verified, causing 73 deaths and 51 injuries. We are outraged that attacks on health care are continuing. pic.twitter.com/8GNUQZFiK9 — WHO Ukraine (@WHOUkraine) April 11, 2022 Meanwhile, the Office of the UN High Commissioner for Human Rights (OHCHR) has recorded 1,793 civilian deaths and 2,439 injuries since the start of the Russian invasion on 24 February and Sunday. Most of the civilian casualties have been caused by “explosive weapons with a wide impact area”, including shelling from heavy artillery and rocket, missile and air strikes. https://data.humdata.org/visualization/ukraine-humanitarian-operations/ “OHCHR believes that the actual figures are considerably higher, as the receipt of information from some locations where intense hostilities have been going on has been delayed and many reports are still pending corroboration,” according to a statement from the office. “This concerns, for example, Mariupol (Donetsk region), Izium (Kharkiv region), Popasna (Luhansk region), and Borodianka (Kyiv region), where there are allegations of numerous civilian casualties. These figures are being further corroborated and are not included in the above statistics.” According to the Prosecutor General’s Office of Ukraine, 176 children had been killed and at least 336 injured as of Sunday. Image Credits: WHO. Pfizer Refuses Cooperation with DNDi on Study of Paxlovid Treatment Adapted to Low Income Countries 08/04/2022 Elaine Ruth Fletcher & Kerry Cullinan Paxlovid Pfizer has so far refused an invitation from the Geneva-based Drugs for Neglected Diseases Initiative (DNDi) to cooperate on a study exploring whether the treatment window of its successful antiviral drug, Paxlovid, could be extended from 5-7 days using another drug compound in addition, Dr Nathalie Strub-Wourgaft, Director of DNDi’s COVID-19 Response, told Health Policy Watch. DNDi wants to test if the key active ingredient of Paxlovid, nirmatrelvir, could be offered in combination with an inhaled corticosteroid, budesonide, in order to extend the treatment window of the life-saving COVID treatment by two more days, Strub-Wourgaft said in an interview. Extending the treatment window is critical for patients in low-income countries because the currently-approved formulation of Paxlovid must be commenced within 3-5 days of COVID symptoms. Meanwhile ANTICOV, a major DNDi-sponsored trial of COVID treatments underway in ten African countries, has revealed that one-half of COVID patients present for treatment after the five day cut-off date. ANTICOV clinical trial. That makes the current Paxlovid combination less than suitable for low- and middle-income country (LMIC) conditions, said Strub-Wourgaft. She is one of the coordinators of the ANTICOV Consortium, a group of 26 African and global research organizations engaged in the clinical trial research on novel COVID drugs for LMICs. On 15 March, DNDi issued a public statement expressing its concern that “efforts to conduct urgently needed studies in low- and middle-income countries (LMICs) utilizing the novel oral antiviral, nirmatrelvir/ritonavir (Paxlovid), are being blocked by Pfizer, which developed the drug. Paxlovid, which uses the common HIV drug ritonavir in combination with nirmatrelvir, has been found to reduce the risk of hospitalization or death by a stunning 89% in patients at high risk of severe COVID-19 disease. But the treatment needs to be taken within three to five days of patients developing symptoms. According to DNDi, “an interim analysis done in the context of the ongoing ANTICOV clinical trial conducted in 10 African countries showed that of the 1180 patients enrolled, more than half present for care after day 5. “To overcome this challenge, it is necessary to explore whether using Paxlovid with other drugs could widen the ‘treatment window’ to at least seven days,” DNDi said in its statement. DNDi also wants to investigate if the drug could be “beneficial for immune-suppressed patients who are the most vulnerable to disease progression but were excluded from phase 3 trials.” DNDi, a Geneva-based not-for-profit research and development organisation, works to deliver new treatments on neglected diseases and serving neglected groups in low- and middle-income countries. Still looking for ways to access nirmatrelvir DNDi drug development. Strub, in her comments to Health Policy Watch, suggested that DNDi, which has a good track record of building cooperation with the pharma industry, was still trying to obtain the drug somehow – or even persuade Pfizer to collaborate. “We would like to test nirmatrelvir/ritonavir in combination, as well, with inhaled budesonide or maybe fluoxetine (brand name Prozac),” said Strub-Wourgaft. “We issued a statement to say that we had asked Pfizer to get access to nirmatrelvir, to work with us on this trial. They denied. We’re continuing to try to get access to this drug.” “We think this [combination] would extend the window of treatment to seven days of symptoms. In the study that they [Pfizer] have done, which is a great study showing really fantastic results, they looked at patients who had five days of symptoms before they were enrolled. “And we have seen for now, in our study in Africa, that half of the patients come after five days of symptoms,” she said. Such delays are typical because COVID diagnosis and treatment services are less widely available and it thus takes people longer to get diagnosed, even if they are symptomatically ill. “There are critically important public health research questions that must be answered quickly – particularly in low- and middle-income countries where access to vaccines remains low,” added Strub-Wourgaft, in the DNDi statement. “It is difficult to understand any rationale for refusing to cooperate in the midst of a global pandemic, and this sets a dangerous precedent since there are many other promising antivirals in the pipeline and these novel treatments will also require follow-on research to determine their optimal use in resource-limited settings.” MPP deal with Pfizer – not enough Pfizer recently signed a deal with another Geneva-based group, the non-profit Medicines Patent Pool, that will allow 35 new manufacturers to produce and supply generic versions of Paxlovid to some 95 low- and middle income countries – in what the company has said is a move to lower the drug’s cost and expand access in low-income countries. But that deal has also been criticised for failing to cover dozens of other middle-income and upper-middle income countries that will have to purchase patented versions of the drug. Although Pfizer had also said that it would create a tiered pricing system for Paxlovid, drug price advocates say that the price remains too high in many settings. In the United States, the government pays Pfizer about $530 for a five day course, although the pills also are in short supply in some US communities. In addition, most of Pfizer’s Paxlovid supply for the first half of 2022 has already been bought up by rich countries, meaning that LMICs will only be able to get about 10 million doses of the drug in the near term. Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates However, even considering the MPP deal and other preferential pricing mechanisms, the fact remains that the version of Paxlovid currently being produced is not an optimal fit for many LMICs, Strub-Wourgaft said. “So for now, if we were to be able to give them Paxlovid, under the current conditions, half of them would not even have access,” she told Health Policy Watch. MPP deals with generic manufacturers may not enable supplies to ANTICOV DNDi is also concerned about the potential difficulty of obtaining generic versions of Paxlovid to conduct the new ANTICOV combination studies, the company has said. “The terms of the Pfizer/Medicines Patent Pool (MPP) licensing agreement to the new generics manufacturers could be interpreted to mean that sub-licensees cannot provide nirmatrelvir/ritonavir for use in the sorts of combination studies that DNDi and others wish to conduct, unless they have explicit written approval from Pfizer. “Some generic manufacturers are also encountering difficulties obtaining Paxlovid as a ‘reference drug’ so that they can conduct the necessary bioequivalence studies to show regulators that their generic version has the same effect in the body, effectively blocking availability of generics for both research and clinical use”, DNDi added in its statement. It has therefore asked Pfizer to not only provide access to nirmatrelvir/ritonavir (Paxlovid) for the DNDi-coordinated ANTICOV trial and other relevant clinical trials, but also to: Remove any ambiguities or restrictions in the Pfizer-MPP licensing agreement that could prevent sub-licensees from supplying such research studies (or publicly clarify that no such restrictions exist); Provide access to Pfizer’s originator product as a ‘reference drug’ so that any interested generic manufacturer can conduct the necessary bioequivalence studies for regulatory approval; and Allocate sufficient quantities of Paxlovid specifically for LMICs and remove all barriers to access to generic nirmatrelvir/ritonavir to enable scale up for care and treatment in LMICs. “Every effort should be made to ensure that clinical studies for COVID-19 treatment are conducted in low- and middle-income countries, and that any products developed reach vulnerable populations,” said Dr John Amuasi, head of the Global Health and Infectious Diseases Research Grou at Kumasi Center for Collaborative Research in Tropical Medicine in Ghana and a principal investigator for ANTICOV. “We must not arrive at a situation where research priorities are determined by the actions or inactions of any company.” Pfizer response – committed to well-controlled trials In response to a request from Health Policy Watch, a Pfizer spokesperson did not provide any clarification of the reasons behind the company’s refusal to participate in the DNDi trial – aimed a making the treatment more suitable to low-income settings. “Pfizer appreciates the importance of gathering additional data and information for governments to help maximize the public health response to the COVID-19 pandemic,” said the spokesperson, adding that the company is committed to “well-controlled, hypothesis-driven clinical studies that can provide data that will be accepted by global regulatory agencies. “Additional studies of PAXLOVID are underway or are being explored, and we will continue to share information as we have it,” the spokesperson added. In addition, “Right now, we are focusing our efforts and resources in a way that maximizes availability of our overall supply, to help ensure access to patients as quickly as possible,” the spokesperson said, noting that the company remains “confident” in the clinical trial results, which showed an 88-89% efficacy rate for the drug, when it was administered to non-hospitalized, high-risk patients within 3-5 days of symptom onset. -Updated 9 April with correction on the price of Paxlovid paid by the US government for patients in the USA and on 11 April with details of Pfizer response. Image Credits: Bobbi-Jean MacKinnon, DNDI/Twitter, DNDi. Artificial Intelligence ‘Boot Camp’ Aims to Accelerate Drug Discovery 08/04/2022 Maayan Hoffman Machine learning is playing an increasingly important role in computing and artificial intelligence. TEL AVIV – Ninety percent of drug candidates fail in clinical trials because of unexpected safety issues or lack of efficacy in human subjects, according to Noga Yerushalmi, Investment Director at M Ventures, the strategic, corporate venture capital arm of Merck. There have been dramatic improvements in omics technologies – that is the collective technologies used to explore molecular behaviour, such as genomics, proteomics, metabolomics, metagenomics and transcriptomics. And this is enabling scientists to analyze potential drug targets more efficiently in terms of their potential impact on a pathogen or disease. But there is no automated solution that harnesses all preclinical data in a way that allows for a reliable assessment of the clinical trial readiness of a new drug candidate. Now, some pharma and research initiatives are hoping to change that, among them AION Labs. Together with its German partner BioMed X, the Israeli-based research alliance, hosted 15 teams of computational biologists, AI researchers and biomedical scientists for a ‘boot camp’ that aims to speed up the drug discovery process and lower costs – harnessing AI technologies in novel ways. Mission: identify critical safety issues before expensive clinical trial stage The latest boot camp cohort The teams were charged with making a proposal for the development of a versatile, next-generation computational platform that can identify hidden safety liability and lack of efficacy, and close identified gaps in the drug candidate pre-clinical data package. “The big problem in drug discovery and development is that after a lot of experiments have been done and we have a new drug candidate, many of these candidates fail in very expensive clinical trials in humans,” Dr. Christian Tidona, founder and managing director of the BioMed X Institute told Health Policy Watch. “That’s because humans are different from mice or a dish in the lab.” The challenge is that pharma companies usually only discover that a drug candidate either is not safe or will not work after years of effort and hundreds of millions of dollars of investment. Companies can invest $5 billion and 12-years’ time, on average, Tidona said, to create the next “blockbuster drug.” “When one thinks about these numbers, he can imagine why some of these drugs are so expensive. Could an AI platform predict if a drug is really ready for the clinic and, if not, tell us what was missed before we go to trial?” Tidona asked. “This is the question. “If drugs can be made more efficiently, medicines can become cheaper and more people in all parts of the world could afford them,” he said. Solving therapeutic challenges Kahina Lang, head of Strategic Innovation at Merck Group, addresses the candidates at the AION Labs boot camp. Based in Rehovot, not far from the the famed Weizmann Institute, AION brings together some of the biggest names in pharma, including AstraZeneca, Merck, Pfizer, and Teva, with young biotech inventors and entrepreneurs, to crack biomedical research challenges together and in a novel way. “We work with each of our pharma partners separately and then together to identify the top research challenges that solving would be majorly impactful for the industry at large,” AION CEO Mati Gill told Health Policy Watch. Then, AION looks for innovators and scientists to develop solutions for them. For last week’s boot camp, 15 applicants from around the world were selected to come to Israel and participate. “The winner receives a $2 million investment, mentorship and access to a wealth of data for model training from these four big pharma companies,” Tidona said. “It is more or less paradise for anyone who wants to start a company.” The concept is based on a model Tidona first developed on the campus of the University of Heidelberg in Germany, with a world-wide network of partner locations. If the company succeeds, the technology belongs to it but will be made available for purchase by the pharma partners. ‘Bringing the promise of AI to fruition’ Guy Spigelman of AWS addresses candidates at the AION Labs bootcamp. Merck’s Yerushalmi said that there have been “all kinds of efforts to make the drug development model more efficient – to expedite it,” but until now it has not worked. When computational approaches to research were first introduced, “it brought a lot of promise, but until now it has not brought as much fruit as we hoped. Now, with AI tools and the amount of data pharma and other companies can generate, we do hope we may be able to bring this promise to fruition.” AI is one of the most sophisticated computational tools. AI analysis has brought “ingenious” solutions to other fields, like the automotive industry, she pointed out. “AI tools and big data have proven themselves in so many other cases, I think it will probably work for our industry too,” Yerushalmi said. “Want to make [drug development] more affordable and shorter, so we can bring drugs to the market faster and cheaper for the benefit of humanity.” Finding the most effective antibodies AION will be looking for the next therapeutic antibodies. This most recent boot camp was AION’s second one so far. Earlier this year, it invited computational biologists and biomedical scientists to propose ideas for discovering therapeutic antibodies. “Advances in protein structure prediction, artificial intelligence algorithms, and increased availability of experimentally determined antigen-antibody structures present a unique opportunity for AI-driven antibody discovery,” AION said in a release. In the coming months, it will hold a third boot camp at which computational biologists, bioinformatics and cheminformatics scientists and AI researchers will propose ideas for the development of a next-generation computational platform to optimize antibodies for targeted therapies with enhanced properties, including developability or manufacturability, stability, aggregation, immunogenicity, pharmacokinetics and tissue distribution. “The ultimate solution is an AI platform that receives sequences of binders and generates novel variants with optimized IgG sequences, biophysical and targeting properties,” a background briefing explained. “The goal of the AI algorithm is to make an existing antibody a better drug while reducing design iterations, optimization of cycle times and lowering attrition rates.” CEPI launches AI-based quest for beta-coronavirus vaccine candidate The AION initiative, while pioneering in the use of AI for drug discovery, is not the only one. On Thursday, the Oslo-based Coalition for Epidemic Preparedness (CEPI) announced that it would provide seed funding of up to US $4.8 million to a consortium to support the AI-based development of betacoronavirus vaccine candidates – the new holy grail for coronavirus vaccines. The research consortium, led by a Norway-based subsidiary of the Japanese NEC Group, which specializes in AI technologies, also includes the European Vaccine Initiative (EVI) and Oslo University Hospital. It aims to establish preclinical proof of concept for an mRNA-based vaccine that protects against a broad range of beta coronaviruses – rather than SARS-CoV2 alone, said CEPI in a press release. NEC will apply its experience in the AI design of immunogens to identify novel vaccine antigens with broad reactivity against beta-coronaviruses. The lead antigens will be selected iteratively and validated in preclinical studies against known beta coronaviruses that already pose a significant epidemic or pandemic risk, such as SARS-CoV, SARS-CoV-2 and MERS-CoV. If the approach is successful, it may also be applicable for developing vaccines against other pathogens in the CEPI portfolio, including ‘Disease X’ – unknown pathogens with pandemic potential that have yet to emerge. What the future holds What the future of AI holds. Tidona, for his part, hopes that AION will spin off 20 new start-ups in the next four to six years. “We are building an innovation ecosystem,” he said, noting that it is attractive to host countries as it provides a draw for youthful talent, which in turn spurs economic development. He added that if the model works well, BioMed X plans to export it to other countries as well. “The focus now is on Israel as our first partner outside Germany,” Tidona said. “But in the future, we hope to have sites” in other places, too. Image Credits: https://www.flickr.com/photos/mikemacmarketing/42271822770/, AION Labs, Elad Malka, Twitter: @WHO, https://www.flickr.com/photos/158301585@N08/43267970922/. Global Health Leaders Call on African Policymakers To Do More to Stop Climate Change 08/04/2022 Paul Adepoju WHO argues that climate-smart initiatives are good for health. But the health sector receives less than 1% of international climate finance, said Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC). Global health leaders have repeatedly called for stepped up investments to both slow down climate change and recognize the health co-benefits of more climate action. But political leaders, including those in low and middle-income countries, still need to do more, Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC) told Health Policy Watch in a briefing on Thursday, World Health Day. Meanwhile, WHO’s Regional Director for Africa, Matshidiso Moeti, enjoined African governments to “prioritize human wellbeing in every strategy and decision,” including halting fossil fuel expansion that ultimately will boomerang on the countries concerned. “I’d like to take this opportunity to call on an African governments to prioritize human wellbeing in every strategy and decision to halt new fossil fuel exploration and subsidies, institute taxes for polluting firms and to implement the WHO air quality guidelines for example,” said Moeti, speaking on this year’s World Health Day theme, ‘Our Planet, Our Health.’ Added Cissé, countries that harness more of their own national and local policies, innovations and resources can make a difference. “Countries can go for some financial incentive policy at a national scale that includes taxes and subsidies; they can also have some innovative policies regarding insurance. They can also give some small scale financial products to low income and other households,” Cissé said. Support to health sector less than 1% of international climate finance Experts are increasingly aware of the multi-faced impacts of the climate crisis on health – as well and the increased precarity of health in the face of deforestation and biodiversity loss as well as unhealthy foods production – which are also driving climate change. So far, however, support to the health sector for climate action still comprises less than 1% of international climate finance investments, Cissé said, speaking at a WHO African Region World Health Day briefing. Health co-benefits of climate mitigation strategies – for instance fewer air pollution-related deaths from cleaner energy investments, also go uncounted in climate strategies. This, despite health being mentioned as a priority in 54% of countries’ Nationally Determined Contributions (NDCs), which are the main instruments now being used for global climate pledges to reduce harmful emissions, under the UN Framework Convention on Climate Change. Cissé who works with the Swiss Tropical and Public Health Institute at the University of Basel in Switzerland, noted that this reflects the low priority still being given to climate change in the context of health. World Health Day at a time of heightened conflict and fragility Joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra (center) and WHO Director-General Dr Tedros Adhanom Ghebreyesus (right) This year’s World Health Day, which marks the April 7, 1948 date of WHO’s founding, comes at a time of both heightened political conflict and greater ecosystem fragility, noted WHO Director-General Dr Tedros Adhanom Ghebreyesus. He was speaking at a joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra. “The pandemic has highlighted the intimate links between the health of humans, animals and the environment. And yet, we’re rapidly making the planet on which all life depends and inhabitable… “The climate crisis is a health crisis,” Tedros said at the Thursday briefing, which concluded a series of face-to-face meetings this week with US Administration officials – the first since President Joe Biden’s inauguration last year. ”Air pollution kills 7 million people every year. And 99% of the world’s population breathes unhealthy air mainly as a result of burning fossil fuels,” Tedros added. (see related story) “Our warming world is facilitating the spread of mosquitoes and diseases they carry. Extreme weather events, biodiversity loss, land degradation, and water scarcity are displacing people and damaging their health,” Tedros said. “Systems that produce highly processed, unhealthy foods are driving a wave of obesity, increasing cancer and heart disease, and generating one-third of greenhouse gas emissions. “As the world recovers from the pandemic we have a choice: we can go back to the way things were or we can change course. We can create societies, economies and products that nurture health and well being, and stop subsidizing those that destroy – because we cannot afford to pump carbon into the atmosphere at the same rate, and still breathe clean air. “We cannot afford the same patterns of consumption and expect less diabetes, hypertension, heart disease and cancer. We must choose. We cannot afford ever-deepening inequalities and expect continued prosperity. We must choose.” Half new fossil fuel exploration and subsidies, prioritize health, says WHO Regional Director Water shortage in Ethiopia. Population exposure to heat is increasing due to climate change. Globally, extreme temperature events are observed to be increasing in their frequency, duration, and magnitude. In Africa, one of the regions of the world that is worst affected by climate change, extreme weather events are having ever greater impacts on food security, water access, and related to that, nutrition and disease transmission. Of the more than 2000 public health events recorded in the African region between 2019 and 2020, more than half were climate-related, said Moeti, speaking from WHO’s Regional Office in Brazzaville. This, she said, represented a 25% increase compared with the previous decade. “In Africa, diarrhoeal diseases are the third leading cause of death and illness in children younger than five, which could be preventable with safe drinking water, adequate sanitation and hygiene, and installation,” Moeti said. “Our analysis showed that waterborne diseases, mainly due to cholera outbreaks, accounted for 40% of climate-related health emergencies in the past 20 years.” In urging African governments to adopt cleaner, healthier policies, she said the main motive is really self-preservation. “Älthough Africa contributes the least to global warming, the continent bears a disproportionate burden of the consequences,” said Moeti. “It’s up to every one of us to promote and support multi-sectoral interventions that address the threat of climate change, while helping to better prepare for future health shocks like the COVID-19 pandemic.” Image Credits: Oxfam East Africa. 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.
Pfizer Refuses Cooperation with DNDi on Study of Paxlovid Treatment Adapted to Low Income Countries 08/04/2022 Elaine Ruth Fletcher & Kerry Cullinan Paxlovid Pfizer has so far refused an invitation from the Geneva-based Drugs for Neglected Diseases Initiative (DNDi) to cooperate on a study exploring whether the treatment window of its successful antiviral drug, Paxlovid, could be extended from 5-7 days using another drug compound in addition, Dr Nathalie Strub-Wourgaft, Director of DNDi’s COVID-19 Response, told Health Policy Watch. DNDi wants to test if the key active ingredient of Paxlovid, nirmatrelvir, could be offered in combination with an inhaled corticosteroid, budesonide, in order to extend the treatment window of the life-saving COVID treatment by two more days, Strub-Wourgaft said in an interview. Extending the treatment window is critical for patients in low-income countries because the currently-approved formulation of Paxlovid must be commenced within 3-5 days of COVID symptoms. Meanwhile ANTICOV, a major DNDi-sponsored trial of COVID treatments underway in ten African countries, has revealed that one-half of COVID patients present for treatment after the five day cut-off date. ANTICOV clinical trial. That makes the current Paxlovid combination less than suitable for low- and middle-income country (LMIC) conditions, said Strub-Wourgaft. She is one of the coordinators of the ANTICOV Consortium, a group of 26 African and global research organizations engaged in the clinical trial research on novel COVID drugs for LMICs. On 15 March, DNDi issued a public statement expressing its concern that “efforts to conduct urgently needed studies in low- and middle-income countries (LMICs) utilizing the novel oral antiviral, nirmatrelvir/ritonavir (Paxlovid), are being blocked by Pfizer, which developed the drug. Paxlovid, which uses the common HIV drug ritonavir in combination with nirmatrelvir, has been found to reduce the risk of hospitalization or death by a stunning 89% in patients at high risk of severe COVID-19 disease. But the treatment needs to be taken within three to five days of patients developing symptoms. According to DNDi, “an interim analysis done in the context of the ongoing ANTICOV clinical trial conducted in 10 African countries showed that of the 1180 patients enrolled, more than half present for care after day 5. “To overcome this challenge, it is necessary to explore whether using Paxlovid with other drugs could widen the ‘treatment window’ to at least seven days,” DNDi said in its statement. DNDi also wants to investigate if the drug could be “beneficial for immune-suppressed patients who are the most vulnerable to disease progression but were excluded from phase 3 trials.” DNDi, a Geneva-based not-for-profit research and development organisation, works to deliver new treatments on neglected diseases and serving neglected groups in low- and middle-income countries. Still looking for ways to access nirmatrelvir DNDi drug development. Strub, in her comments to Health Policy Watch, suggested that DNDi, which has a good track record of building cooperation with the pharma industry, was still trying to obtain the drug somehow – or even persuade Pfizer to collaborate. “We would like to test nirmatrelvir/ritonavir in combination, as well, with inhaled budesonide or maybe fluoxetine (brand name Prozac),” said Strub-Wourgaft. “We issued a statement to say that we had asked Pfizer to get access to nirmatrelvir, to work with us on this trial. They denied. We’re continuing to try to get access to this drug.” “We think this [combination] would extend the window of treatment to seven days of symptoms. In the study that they [Pfizer] have done, which is a great study showing really fantastic results, they looked at patients who had five days of symptoms before they were enrolled. “And we have seen for now, in our study in Africa, that half of the patients come after five days of symptoms,” she said. Such delays are typical because COVID diagnosis and treatment services are less widely available and it thus takes people longer to get diagnosed, even if they are symptomatically ill. “There are critically important public health research questions that must be answered quickly – particularly in low- and middle-income countries where access to vaccines remains low,” added Strub-Wourgaft, in the DNDi statement. “It is difficult to understand any rationale for refusing to cooperate in the midst of a global pandemic, and this sets a dangerous precedent since there are many other promising antivirals in the pipeline and these novel treatments will also require follow-on research to determine their optimal use in resource-limited settings.” MPP deal with Pfizer – not enough Pfizer recently signed a deal with another Geneva-based group, the non-profit Medicines Patent Pool, that will allow 35 new manufacturers to produce and supply generic versions of Paxlovid to some 95 low- and middle income countries – in what the company has said is a move to lower the drug’s cost and expand access in low-income countries. But that deal has also been criticised for failing to cover dozens of other middle-income and upper-middle income countries that will have to purchase patented versions of the drug. Although Pfizer had also said that it would create a tiered pricing system for Paxlovid, drug price advocates say that the price remains too high in many settings. In the United States, the government pays Pfizer about $530 for a five day course, although the pills also are in short supply in some US communities. In addition, most of Pfizer’s Paxlovid supply for the first half of 2022 has already been bought up by rich countries, meaning that LMICs will only be able to get about 10 million doses of the drug in the near term. Pfizer’s Paxlovid Goes Generic in 95 Countries – Too Little, Too Late, say Access Advocates However, even considering the MPP deal and other preferential pricing mechanisms, the fact remains that the version of Paxlovid currently being produced is not an optimal fit for many LMICs, Strub-Wourgaft said. “So for now, if we were to be able to give them Paxlovid, under the current conditions, half of them would not even have access,” she told Health Policy Watch. MPP deals with generic manufacturers may not enable supplies to ANTICOV DNDi is also concerned about the potential difficulty of obtaining generic versions of Paxlovid to conduct the new ANTICOV combination studies, the company has said. “The terms of the Pfizer/Medicines Patent Pool (MPP) licensing agreement to the new generics manufacturers could be interpreted to mean that sub-licensees cannot provide nirmatrelvir/ritonavir for use in the sorts of combination studies that DNDi and others wish to conduct, unless they have explicit written approval from Pfizer. “Some generic manufacturers are also encountering difficulties obtaining Paxlovid as a ‘reference drug’ so that they can conduct the necessary bioequivalence studies to show regulators that their generic version has the same effect in the body, effectively blocking availability of generics for both research and clinical use”, DNDi added in its statement. It has therefore asked Pfizer to not only provide access to nirmatrelvir/ritonavir (Paxlovid) for the DNDi-coordinated ANTICOV trial and other relevant clinical trials, but also to: Remove any ambiguities or restrictions in the Pfizer-MPP licensing agreement that could prevent sub-licensees from supplying such research studies (or publicly clarify that no such restrictions exist); Provide access to Pfizer’s originator product as a ‘reference drug’ so that any interested generic manufacturer can conduct the necessary bioequivalence studies for regulatory approval; and Allocate sufficient quantities of Paxlovid specifically for LMICs and remove all barriers to access to generic nirmatrelvir/ritonavir to enable scale up for care and treatment in LMICs. “Every effort should be made to ensure that clinical studies for COVID-19 treatment are conducted in low- and middle-income countries, and that any products developed reach vulnerable populations,” said Dr John Amuasi, head of the Global Health and Infectious Diseases Research Grou at Kumasi Center for Collaborative Research in Tropical Medicine in Ghana and a principal investigator for ANTICOV. “We must not arrive at a situation where research priorities are determined by the actions or inactions of any company.” Pfizer response – committed to well-controlled trials In response to a request from Health Policy Watch, a Pfizer spokesperson did not provide any clarification of the reasons behind the company’s refusal to participate in the DNDi trial – aimed a making the treatment more suitable to low-income settings. “Pfizer appreciates the importance of gathering additional data and information for governments to help maximize the public health response to the COVID-19 pandemic,” said the spokesperson, adding that the company is committed to “well-controlled, hypothesis-driven clinical studies that can provide data that will be accepted by global regulatory agencies. “Additional studies of PAXLOVID are underway or are being explored, and we will continue to share information as we have it,” the spokesperson added. In addition, “Right now, we are focusing our efforts and resources in a way that maximizes availability of our overall supply, to help ensure access to patients as quickly as possible,” the spokesperson said, noting that the company remains “confident” in the clinical trial results, which showed an 88-89% efficacy rate for the drug, when it was administered to non-hospitalized, high-risk patients within 3-5 days of symptom onset. -Updated 9 April with correction on the price of Paxlovid paid by the US government for patients in the USA and on 11 April with details of Pfizer response. Image Credits: Bobbi-Jean MacKinnon, DNDI/Twitter, DNDi. Artificial Intelligence ‘Boot Camp’ Aims to Accelerate Drug Discovery 08/04/2022 Maayan Hoffman Machine learning is playing an increasingly important role in computing and artificial intelligence. TEL AVIV – Ninety percent of drug candidates fail in clinical trials because of unexpected safety issues or lack of efficacy in human subjects, according to Noga Yerushalmi, Investment Director at M Ventures, the strategic, corporate venture capital arm of Merck. There have been dramatic improvements in omics technologies – that is the collective technologies used to explore molecular behaviour, such as genomics, proteomics, metabolomics, metagenomics and transcriptomics. And this is enabling scientists to analyze potential drug targets more efficiently in terms of their potential impact on a pathogen or disease. But there is no automated solution that harnesses all preclinical data in a way that allows for a reliable assessment of the clinical trial readiness of a new drug candidate. Now, some pharma and research initiatives are hoping to change that, among them AION Labs. Together with its German partner BioMed X, the Israeli-based research alliance, hosted 15 teams of computational biologists, AI researchers and biomedical scientists for a ‘boot camp’ that aims to speed up the drug discovery process and lower costs – harnessing AI technologies in novel ways. Mission: identify critical safety issues before expensive clinical trial stage The latest boot camp cohort The teams were charged with making a proposal for the development of a versatile, next-generation computational platform that can identify hidden safety liability and lack of efficacy, and close identified gaps in the drug candidate pre-clinical data package. “The big problem in drug discovery and development is that after a lot of experiments have been done and we have a new drug candidate, many of these candidates fail in very expensive clinical trials in humans,” Dr. Christian Tidona, founder and managing director of the BioMed X Institute told Health Policy Watch. “That’s because humans are different from mice or a dish in the lab.” The challenge is that pharma companies usually only discover that a drug candidate either is not safe or will not work after years of effort and hundreds of millions of dollars of investment. Companies can invest $5 billion and 12-years’ time, on average, Tidona said, to create the next “blockbuster drug.” “When one thinks about these numbers, he can imagine why some of these drugs are so expensive. Could an AI platform predict if a drug is really ready for the clinic and, if not, tell us what was missed before we go to trial?” Tidona asked. “This is the question. “If drugs can be made more efficiently, medicines can become cheaper and more people in all parts of the world could afford them,” he said. Solving therapeutic challenges Kahina Lang, head of Strategic Innovation at Merck Group, addresses the candidates at the AION Labs boot camp. Based in Rehovot, not far from the the famed Weizmann Institute, AION brings together some of the biggest names in pharma, including AstraZeneca, Merck, Pfizer, and Teva, with young biotech inventors and entrepreneurs, to crack biomedical research challenges together and in a novel way. “We work with each of our pharma partners separately and then together to identify the top research challenges that solving would be majorly impactful for the industry at large,” AION CEO Mati Gill told Health Policy Watch. Then, AION looks for innovators and scientists to develop solutions for them. For last week’s boot camp, 15 applicants from around the world were selected to come to Israel and participate. “The winner receives a $2 million investment, mentorship and access to a wealth of data for model training from these four big pharma companies,” Tidona said. “It is more or less paradise for anyone who wants to start a company.” The concept is based on a model Tidona first developed on the campus of the University of Heidelberg in Germany, with a world-wide network of partner locations. If the company succeeds, the technology belongs to it but will be made available for purchase by the pharma partners. ‘Bringing the promise of AI to fruition’ Guy Spigelman of AWS addresses candidates at the AION Labs bootcamp. Merck’s Yerushalmi said that there have been “all kinds of efforts to make the drug development model more efficient – to expedite it,” but until now it has not worked. When computational approaches to research were first introduced, “it brought a lot of promise, but until now it has not brought as much fruit as we hoped. Now, with AI tools and the amount of data pharma and other companies can generate, we do hope we may be able to bring this promise to fruition.” AI is one of the most sophisticated computational tools. AI analysis has brought “ingenious” solutions to other fields, like the automotive industry, she pointed out. “AI tools and big data have proven themselves in so many other cases, I think it will probably work for our industry too,” Yerushalmi said. “Want to make [drug development] more affordable and shorter, so we can bring drugs to the market faster and cheaper for the benefit of humanity.” Finding the most effective antibodies AION will be looking for the next therapeutic antibodies. This most recent boot camp was AION’s second one so far. Earlier this year, it invited computational biologists and biomedical scientists to propose ideas for discovering therapeutic antibodies. “Advances in protein structure prediction, artificial intelligence algorithms, and increased availability of experimentally determined antigen-antibody structures present a unique opportunity for AI-driven antibody discovery,” AION said in a release. In the coming months, it will hold a third boot camp at which computational biologists, bioinformatics and cheminformatics scientists and AI researchers will propose ideas for the development of a next-generation computational platform to optimize antibodies for targeted therapies with enhanced properties, including developability or manufacturability, stability, aggregation, immunogenicity, pharmacokinetics and tissue distribution. “The ultimate solution is an AI platform that receives sequences of binders and generates novel variants with optimized IgG sequences, biophysical and targeting properties,” a background briefing explained. “The goal of the AI algorithm is to make an existing antibody a better drug while reducing design iterations, optimization of cycle times and lowering attrition rates.” CEPI launches AI-based quest for beta-coronavirus vaccine candidate The AION initiative, while pioneering in the use of AI for drug discovery, is not the only one. On Thursday, the Oslo-based Coalition for Epidemic Preparedness (CEPI) announced that it would provide seed funding of up to US $4.8 million to a consortium to support the AI-based development of betacoronavirus vaccine candidates – the new holy grail for coronavirus vaccines. The research consortium, led by a Norway-based subsidiary of the Japanese NEC Group, which specializes in AI technologies, also includes the European Vaccine Initiative (EVI) and Oslo University Hospital. It aims to establish preclinical proof of concept for an mRNA-based vaccine that protects against a broad range of beta coronaviruses – rather than SARS-CoV2 alone, said CEPI in a press release. NEC will apply its experience in the AI design of immunogens to identify novel vaccine antigens with broad reactivity against beta-coronaviruses. The lead antigens will be selected iteratively and validated in preclinical studies against known beta coronaviruses that already pose a significant epidemic or pandemic risk, such as SARS-CoV, SARS-CoV-2 and MERS-CoV. If the approach is successful, it may also be applicable for developing vaccines against other pathogens in the CEPI portfolio, including ‘Disease X’ – unknown pathogens with pandemic potential that have yet to emerge. What the future holds What the future of AI holds. Tidona, for his part, hopes that AION will spin off 20 new start-ups in the next four to six years. “We are building an innovation ecosystem,” he said, noting that it is attractive to host countries as it provides a draw for youthful talent, which in turn spurs economic development. He added that if the model works well, BioMed X plans to export it to other countries as well. “The focus now is on Israel as our first partner outside Germany,” Tidona said. “But in the future, we hope to have sites” in other places, too. Image Credits: https://www.flickr.com/photos/mikemacmarketing/42271822770/, AION Labs, Elad Malka, Twitter: @WHO, https://www.flickr.com/photos/158301585@N08/43267970922/. Global Health Leaders Call on African Policymakers To Do More to Stop Climate Change 08/04/2022 Paul Adepoju WHO argues that climate-smart initiatives are good for health. But the health sector receives less than 1% of international climate finance, said Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC). Global health leaders have repeatedly called for stepped up investments to both slow down climate change and recognize the health co-benefits of more climate action. But political leaders, including those in low and middle-income countries, still need to do more, Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC) told Health Policy Watch in a briefing on Thursday, World Health Day. Meanwhile, WHO’s Regional Director for Africa, Matshidiso Moeti, enjoined African governments to “prioritize human wellbeing in every strategy and decision,” including halting fossil fuel expansion that ultimately will boomerang on the countries concerned. “I’d like to take this opportunity to call on an African governments to prioritize human wellbeing in every strategy and decision to halt new fossil fuel exploration and subsidies, institute taxes for polluting firms and to implement the WHO air quality guidelines for example,” said Moeti, speaking on this year’s World Health Day theme, ‘Our Planet, Our Health.’ Added Cissé, countries that harness more of their own national and local policies, innovations and resources can make a difference. “Countries can go for some financial incentive policy at a national scale that includes taxes and subsidies; they can also have some innovative policies regarding insurance. They can also give some small scale financial products to low income and other households,” Cissé said. Support to health sector less than 1% of international climate finance Experts are increasingly aware of the multi-faced impacts of the climate crisis on health – as well and the increased precarity of health in the face of deforestation and biodiversity loss as well as unhealthy foods production – which are also driving climate change. So far, however, support to the health sector for climate action still comprises less than 1% of international climate finance investments, Cissé said, speaking at a WHO African Region World Health Day briefing. Health co-benefits of climate mitigation strategies – for instance fewer air pollution-related deaths from cleaner energy investments, also go uncounted in climate strategies. This, despite health being mentioned as a priority in 54% of countries’ Nationally Determined Contributions (NDCs), which are the main instruments now being used for global climate pledges to reduce harmful emissions, under the UN Framework Convention on Climate Change. Cissé who works with the Swiss Tropical and Public Health Institute at the University of Basel in Switzerland, noted that this reflects the low priority still being given to climate change in the context of health. World Health Day at a time of heightened conflict and fragility Joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra (center) and WHO Director-General Dr Tedros Adhanom Ghebreyesus (right) This year’s World Health Day, which marks the April 7, 1948 date of WHO’s founding, comes at a time of both heightened political conflict and greater ecosystem fragility, noted WHO Director-General Dr Tedros Adhanom Ghebreyesus. He was speaking at a joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra. “The pandemic has highlighted the intimate links between the health of humans, animals and the environment. And yet, we’re rapidly making the planet on which all life depends and inhabitable… “The climate crisis is a health crisis,” Tedros said at the Thursday briefing, which concluded a series of face-to-face meetings this week with US Administration officials – the first since President Joe Biden’s inauguration last year. ”Air pollution kills 7 million people every year. And 99% of the world’s population breathes unhealthy air mainly as a result of burning fossil fuels,” Tedros added. (see related story) “Our warming world is facilitating the spread of mosquitoes and diseases they carry. Extreme weather events, biodiversity loss, land degradation, and water scarcity are displacing people and damaging their health,” Tedros said. “Systems that produce highly processed, unhealthy foods are driving a wave of obesity, increasing cancer and heart disease, and generating one-third of greenhouse gas emissions. “As the world recovers from the pandemic we have a choice: we can go back to the way things were or we can change course. We can create societies, economies and products that nurture health and well being, and stop subsidizing those that destroy – because we cannot afford to pump carbon into the atmosphere at the same rate, and still breathe clean air. “We cannot afford the same patterns of consumption and expect less diabetes, hypertension, heart disease and cancer. We must choose. We cannot afford ever-deepening inequalities and expect continued prosperity. We must choose.” Half new fossil fuel exploration and subsidies, prioritize health, says WHO Regional Director Water shortage in Ethiopia. Population exposure to heat is increasing due to climate change. Globally, extreme temperature events are observed to be increasing in their frequency, duration, and magnitude. In Africa, one of the regions of the world that is worst affected by climate change, extreme weather events are having ever greater impacts on food security, water access, and related to that, nutrition and disease transmission. Of the more than 2000 public health events recorded in the African region between 2019 and 2020, more than half were climate-related, said Moeti, speaking from WHO’s Regional Office in Brazzaville. This, she said, represented a 25% increase compared with the previous decade. “In Africa, diarrhoeal diseases are the third leading cause of death and illness in children younger than five, which could be preventable with safe drinking water, adequate sanitation and hygiene, and installation,” Moeti said. “Our analysis showed that waterborne diseases, mainly due to cholera outbreaks, accounted for 40% of climate-related health emergencies in the past 20 years.” In urging African governments to adopt cleaner, healthier policies, she said the main motive is really self-preservation. “Älthough Africa contributes the least to global warming, the continent bears a disproportionate burden of the consequences,” said Moeti. “It’s up to every one of us to promote and support multi-sectoral interventions that address the threat of climate change, while helping to better prepare for future health shocks like the COVID-19 pandemic.” Image Credits: Oxfam East Africa. 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.
Artificial Intelligence ‘Boot Camp’ Aims to Accelerate Drug Discovery 08/04/2022 Maayan Hoffman Machine learning is playing an increasingly important role in computing and artificial intelligence. TEL AVIV – Ninety percent of drug candidates fail in clinical trials because of unexpected safety issues or lack of efficacy in human subjects, according to Noga Yerushalmi, Investment Director at M Ventures, the strategic, corporate venture capital arm of Merck. There have been dramatic improvements in omics technologies – that is the collective technologies used to explore molecular behaviour, such as genomics, proteomics, metabolomics, metagenomics and transcriptomics. And this is enabling scientists to analyze potential drug targets more efficiently in terms of their potential impact on a pathogen or disease. But there is no automated solution that harnesses all preclinical data in a way that allows for a reliable assessment of the clinical trial readiness of a new drug candidate. Now, some pharma and research initiatives are hoping to change that, among them AION Labs. Together with its German partner BioMed X, the Israeli-based research alliance, hosted 15 teams of computational biologists, AI researchers and biomedical scientists for a ‘boot camp’ that aims to speed up the drug discovery process and lower costs – harnessing AI technologies in novel ways. Mission: identify critical safety issues before expensive clinical trial stage The latest boot camp cohort The teams were charged with making a proposal for the development of a versatile, next-generation computational platform that can identify hidden safety liability and lack of efficacy, and close identified gaps in the drug candidate pre-clinical data package. “The big problem in drug discovery and development is that after a lot of experiments have been done and we have a new drug candidate, many of these candidates fail in very expensive clinical trials in humans,” Dr. Christian Tidona, founder and managing director of the BioMed X Institute told Health Policy Watch. “That’s because humans are different from mice or a dish in the lab.” The challenge is that pharma companies usually only discover that a drug candidate either is not safe or will not work after years of effort and hundreds of millions of dollars of investment. Companies can invest $5 billion and 12-years’ time, on average, Tidona said, to create the next “blockbuster drug.” “When one thinks about these numbers, he can imagine why some of these drugs are so expensive. Could an AI platform predict if a drug is really ready for the clinic and, if not, tell us what was missed before we go to trial?” Tidona asked. “This is the question. “If drugs can be made more efficiently, medicines can become cheaper and more people in all parts of the world could afford them,” he said. Solving therapeutic challenges Kahina Lang, head of Strategic Innovation at Merck Group, addresses the candidates at the AION Labs boot camp. Based in Rehovot, not far from the the famed Weizmann Institute, AION brings together some of the biggest names in pharma, including AstraZeneca, Merck, Pfizer, and Teva, with young biotech inventors and entrepreneurs, to crack biomedical research challenges together and in a novel way. “We work with each of our pharma partners separately and then together to identify the top research challenges that solving would be majorly impactful for the industry at large,” AION CEO Mati Gill told Health Policy Watch. Then, AION looks for innovators and scientists to develop solutions for them. For last week’s boot camp, 15 applicants from around the world were selected to come to Israel and participate. “The winner receives a $2 million investment, mentorship and access to a wealth of data for model training from these four big pharma companies,” Tidona said. “It is more or less paradise for anyone who wants to start a company.” The concept is based on a model Tidona first developed on the campus of the University of Heidelberg in Germany, with a world-wide network of partner locations. If the company succeeds, the technology belongs to it but will be made available for purchase by the pharma partners. ‘Bringing the promise of AI to fruition’ Guy Spigelman of AWS addresses candidates at the AION Labs bootcamp. Merck’s Yerushalmi said that there have been “all kinds of efforts to make the drug development model more efficient – to expedite it,” but until now it has not worked. When computational approaches to research were first introduced, “it brought a lot of promise, but until now it has not brought as much fruit as we hoped. Now, with AI tools and the amount of data pharma and other companies can generate, we do hope we may be able to bring this promise to fruition.” AI is one of the most sophisticated computational tools. AI analysis has brought “ingenious” solutions to other fields, like the automotive industry, she pointed out. “AI tools and big data have proven themselves in so many other cases, I think it will probably work for our industry too,” Yerushalmi said. “Want to make [drug development] more affordable and shorter, so we can bring drugs to the market faster and cheaper for the benefit of humanity.” Finding the most effective antibodies AION will be looking for the next therapeutic antibodies. This most recent boot camp was AION’s second one so far. Earlier this year, it invited computational biologists and biomedical scientists to propose ideas for discovering therapeutic antibodies. “Advances in protein structure prediction, artificial intelligence algorithms, and increased availability of experimentally determined antigen-antibody structures present a unique opportunity for AI-driven antibody discovery,” AION said in a release. In the coming months, it will hold a third boot camp at which computational biologists, bioinformatics and cheminformatics scientists and AI researchers will propose ideas for the development of a next-generation computational platform to optimize antibodies for targeted therapies with enhanced properties, including developability or manufacturability, stability, aggregation, immunogenicity, pharmacokinetics and tissue distribution. “The ultimate solution is an AI platform that receives sequences of binders and generates novel variants with optimized IgG sequences, biophysical and targeting properties,” a background briefing explained. “The goal of the AI algorithm is to make an existing antibody a better drug while reducing design iterations, optimization of cycle times and lowering attrition rates.” CEPI launches AI-based quest for beta-coronavirus vaccine candidate The AION initiative, while pioneering in the use of AI for drug discovery, is not the only one. On Thursday, the Oslo-based Coalition for Epidemic Preparedness (CEPI) announced that it would provide seed funding of up to US $4.8 million to a consortium to support the AI-based development of betacoronavirus vaccine candidates – the new holy grail for coronavirus vaccines. The research consortium, led by a Norway-based subsidiary of the Japanese NEC Group, which specializes in AI technologies, also includes the European Vaccine Initiative (EVI) and Oslo University Hospital. It aims to establish preclinical proof of concept for an mRNA-based vaccine that protects against a broad range of beta coronaviruses – rather than SARS-CoV2 alone, said CEPI in a press release. NEC will apply its experience in the AI design of immunogens to identify novel vaccine antigens with broad reactivity against beta-coronaviruses. The lead antigens will be selected iteratively and validated in preclinical studies against known beta coronaviruses that already pose a significant epidemic or pandemic risk, such as SARS-CoV, SARS-CoV-2 and MERS-CoV. If the approach is successful, it may also be applicable for developing vaccines against other pathogens in the CEPI portfolio, including ‘Disease X’ – unknown pathogens with pandemic potential that have yet to emerge. What the future holds What the future of AI holds. Tidona, for his part, hopes that AION will spin off 20 new start-ups in the next four to six years. “We are building an innovation ecosystem,” he said, noting that it is attractive to host countries as it provides a draw for youthful talent, which in turn spurs economic development. He added that if the model works well, BioMed X plans to export it to other countries as well. “The focus now is on Israel as our first partner outside Germany,” Tidona said. “But in the future, we hope to have sites” in other places, too. Image Credits: https://www.flickr.com/photos/mikemacmarketing/42271822770/, AION Labs, Elad Malka, Twitter: @WHO, https://www.flickr.com/photos/158301585@N08/43267970922/. Global Health Leaders Call on African Policymakers To Do More to Stop Climate Change 08/04/2022 Paul Adepoju WHO argues that climate-smart initiatives are good for health. But the health sector receives less than 1% of international climate finance, said Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC). Global health leaders have repeatedly called for stepped up investments to both slow down climate change and recognize the health co-benefits of more climate action. But political leaders, including those in low and middle-income countries, still need to do more, Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC) told Health Policy Watch in a briefing on Thursday, World Health Day. Meanwhile, WHO’s Regional Director for Africa, Matshidiso Moeti, enjoined African governments to “prioritize human wellbeing in every strategy and decision,” including halting fossil fuel expansion that ultimately will boomerang on the countries concerned. “I’d like to take this opportunity to call on an African governments to prioritize human wellbeing in every strategy and decision to halt new fossil fuel exploration and subsidies, institute taxes for polluting firms and to implement the WHO air quality guidelines for example,” said Moeti, speaking on this year’s World Health Day theme, ‘Our Planet, Our Health.’ Added Cissé, countries that harness more of their own national and local policies, innovations and resources can make a difference. “Countries can go for some financial incentive policy at a national scale that includes taxes and subsidies; they can also have some innovative policies regarding insurance. They can also give some small scale financial products to low income and other households,” Cissé said. Support to health sector less than 1% of international climate finance Experts are increasingly aware of the multi-faced impacts of the climate crisis on health – as well and the increased precarity of health in the face of deforestation and biodiversity loss as well as unhealthy foods production – which are also driving climate change. So far, however, support to the health sector for climate action still comprises less than 1% of international climate finance investments, Cissé said, speaking at a WHO African Region World Health Day briefing. Health co-benefits of climate mitigation strategies – for instance fewer air pollution-related deaths from cleaner energy investments, also go uncounted in climate strategies. This, despite health being mentioned as a priority in 54% of countries’ Nationally Determined Contributions (NDCs), which are the main instruments now being used for global climate pledges to reduce harmful emissions, under the UN Framework Convention on Climate Change. Cissé who works with the Swiss Tropical and Public Health Institute at the University of Basel in Switzerland, noted that this reflects the low priority still being given to climate change in the context of health. World Health Day at a time of heightened conflict and fragility Joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra (center) and WHO Director-General Dr Tedros Adhanom Ghebreyesus (right) This year’s World Health Day, which marks the April 7, 1948 date of WHO’s founding, comes at a time of both heightened political conflict and greater ecosystem fragility, noted WHO Director-General Dr Tedros Adhanom Ghebreyesus. He was speaking at a joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra. “The pandemic has highlighted the intimate links between the health of humans, animals and the environment. And yet, we’re rapidly making the planet on which all life depends and inhabitable… “The climate crisis is a health crisis,” Tedros said at the Thursday briefing, which concluded a series of face-to-face meetings this week with US Administration officials – the first since President Joe Biden’s inauguration last year. ”Air pollution kills 7 million people every year. And 99% of the world’s population breathes unhealthy air mainly as a result of burning fossil fuels,” Tedros added. (see related story) “Our warming world is facilitating the spread of mosquitoes and diseases they carry. Extreme weather events, biodiversity loss, land degradation, and water scarcity are displacing people and damaging their health,” Tedros said. “Systems that produce highly processed, unhealthy foods are driving a wave of obesity, increasing cancer and heart disease, and generating one-third of greenhouse gas emissions. “As the world recovers from the pandemic we have a choice: we can go back to the way things were or we can change course. We can create societies, economies and products that nurture health and well being, and stop subsidizing those that destroy – because we cannot afford to pump carbon into the atmosphere at the same rate, and still breathe clean air. “We cannot afford the same patterns of consumption and expect less diabetes, hypertension, heart disease and cancer. We must choose. We cannot afford ever-deepening inequalities and expect continued prosperity. We must choose.” Half new fossil fuel exploration and subsidies, prioritize health, says WHO Regional Director Water shortage in Ethiopia. Population exposure to heat is increasing due to climate change. Globally, extreme temperature events are observed to be increasing in their frequency, duration, and magnitude. In Africa, one of the regions of the world that is worst affected by climate change, extreme weather events are having ever greater impacts on food security, water access, and related to that, nutrition and disease transmission. Of the more than 2000 public health events recorded in the African region between 2019 and 2020, more than half were climate-related, said Moeti, speaking from WHO’s Regional Office in Brazzaville. This, she said, represented a 25% increase compared with the previous decade. “In Africa, diarrhoeal diseases are the third leading cause of death and illness in children younger than five, which could be preventable with safe drinking water, adequate sanitation and hygiene, and installation,” Moeti said. “Our analysis showed that waterborne diseases, mainly due to cholera outbreaks, accounted for 40% of climate-related health emergencies in the past 20 years.” In urging African governments to adopt cleaner, healthier policies, she said the main motive is really self-preservation. “Älthough Africa contributes the least to global warming, the continent bears a disproportionate burden of the consequences,” said Moeti. “It’s up to every one of us to promote and support multi-sectoral interventions that address the threat of climate change, while helping to better prepare for future health shocks like the COVID-19 pandemic.” Image Credits: Oxfam East Africa. 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
Global Health Leaders Call on African Policymakers To Do More to Stop Climate Change 08/04/2022 Paul Adepoju WHO argues that climate-smart initiatives are good for health. But the health sector receives less than 1% of international climate finance, said Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC). Global health leaders have repeatedly called for stepped up investments to both slow down climate change and recognize the health co-benefits of more climate action. But political leaders, including those in low and middle-income countries, still need to do more, Prof. Guéladio Cissé, Coordinating Lead Author of the Intergovernmental Panel on Climate Change (IPCC) told Health Policy Watch in a briefing on Thursday, World Health Day. Meanwhile, WHO’s Regional Director for Africa, Matshidiso Moeti, enjoined African governments to “prioritize human wellbeing in every strategy and decision,” including halting fossil fuel expansion that ultimately will boomerang on the countries concerned. “I’d like to take this opportunity to call on an African governments to prioritize human wellbeing in every strategy and decision to halt new fossil fuel exploration and subsidies, institute taxes for polluting firms and to implement the WHO air quality guidelines for example,” said Moeti, speaking on this year’s World Health Day theme, ‘Our Planet, Our Health.’ Added Cissé, countries that harness more of their own national and local policies, innovations and resources can make a difference. “Countries can go for some financial incentive policy at a national scale that includes taxes and subsidies; they can also have some innovative policies regarding insurance. They can also give some small scale financial products to low income and other households,” Cissé said. Support to health sector less than 1% of international climate finance Experts are increasingly aware of the multi-faced impacts of the climate crisis on health – as well and the increased precarity of health in the face of deforestation and biodiversity loss as well as unhealthy foods production – which are also driving climate change. So far, however, support to the health sector for climate action still comprises less than 1% of international climate finance investments, Cissé said, speaking at a WHO African Region World Health Day briefing. Health co-benefits of climate mitigation strategies – for instance fewer air pollution-related deaths from cleaner energy investments, also go uncounted in climate strategies. This, despite health being mentioned as a priority in 54% of countries’ Nationally Determined Contributions (NDCs), which are the main instruments now being used for global climate pledges to reduce harmful emissions, under the UN Framework Convention on Climate Change. Cissé who works with the Swiss Tropical and Public Health Institute at the University of Basel in Switzerland, noted that this reflects the low priority still being given to climate change in the context of health. World Health Day at a time of heightened conflict and fragility Joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra (center) and WHO Director-General Dr Tedros Adhanom Ghebreyesus (right) This year’s World Health Day, which marks the April 7, 1948 date of WHO’s founding, comes at a time of both heightened political conflict and greater ecosystem fragility, noted WHO Director-General Dr Tedros Adhanom Ghebreyesus. He was speaking at a joint press conference in Washington DC with US Secretary of Health and Human Services Anthony Becerra. “The pandemic has highlighted the intimate links between the health of humans, animals and the environment. And yet, we’re rapidly making the planet on which all life depends and inhabitable… “The climate crisis is a health crisis,” Tedros said at the Thursday briefing, which concluded a series of face-to-face meetings this week with US Administration officials – the first since President Joe Biden’s inauguration last year. ”Air pollution kills 7 million people every year. And 99% of the world’s population breathes unhealthy air mainly as a result of burning fossil fuels,” Tedros added. (see related story) “Our warming world is facilitating the spread of mosquitoes and diseases they carry. Extreme weather events, biodiversity loss, land degradation, and water scarcity are displacing people and damaging their health,” Tedros said. “Systems that produce highly processed, unhealthy foods are driving a wave of obesity, increasing cancer and heart disease, and generating one-third of greenhouse gas emissions. “As the world recovers from the pandemic we have a choice: we can go back to the way things were or we can change course. We can create societies, economies and products that nurture health and well being, and stop subsidizing those that destroy – because we cannot afford to pump carbon into the atmosphere at the same rate, and still breathe clean air. “We cannot afford the same patterns of consumption and expect less diabetes, hypertension, heart disease and cancer. We must choose. We cannot afford ever-deepening inequalities and expect continued prosperity. We must choose.” Half new fossil fuel exploration and subsidies, prioritize health, says WHO Regional Director Water shortage in Ethiopia. Population exposure to heat is increasing due to climate change. Globally, extreme temperature events are observed to be increasing in their frequency, duration, and magnitude. In Africa, one of the regions of the world that is worst affected by climate change, extreme weather events are having ever greater impacts on food security, water access, and related to that, nutrition and disease transmission. Of the more than 2000 public health events recorded in the African region between 2019 and 2020, more than half were climate-related, said Moeti, speaking from WHO’s Regional Office in Brazzaville. This, she said, represented a 25% increase compared with the previous decade. “In Africa, diarrhoeal diseases are the third leading cause of death and illness in children younger than five, which could be preventable with safe drinking water, adequate sanitation and hygiene, and installation,” Moeti said. “Our analysis showed that waterborne diseases, mainly due to cholera outbreaks, accounted for 40% of climate-related health emergencies in the past 20 years.” In urging African governments to adopt cleaner, healthier policies, she said the main motive is really self-preservation. “Älthough Africa contributes the least to global warming, the continent bears a disproportionate burden of the consequences,” said Moeti. “It’s up to every one of us to promote and support multi-sectoral interventions that address the threat of climate change, while helping to better prepare for future health shocks like the COVID-19 pandemic.” Image Credits: Oxfam East Africa. Posts navigation Older postsNewer posts