Monkeypox Cases Drop 21% Globally As WHO Weighs ‘Fractional’ Vaccine Dose Strategy 25/08/2022 John Heilprin Men queing for the monkeypox vaccine The global number of weekly new cases of monkeypox reported to the World Health Organization (WHO) declined by 21% for the first time since the infection that has been endemic to central and west Africa began to appear around the world earlier this year. Cases continued rising sharply in the Americas, however, in contrast to recent declines in European hotspots, WHO said in a report on Thursday showing 5,907 new monkeypox cases were reported in the past week, down from 7,477 new cases the previous week. That is a dramatic reversal from the 20% weekly increases in reported new monkeypox cases over the past month. More than 45,000 cases have been reported in 98 countries since late April. After four consecutive weeks of rising monkeypox cases globally, WHO says, the overall weekly decrease may reflect early signs of a declining infection rate in the European region but it will take time to see if that is sustained. Monkeypox cases in the Americas were still rising sharply, accounting for 60% of all cases compared to Europe’s 38% in the past month. WHO officials, meanwhile, say they are examining proposals to split scarce monkeypox vaccines doses to stretch supplies — a strategy adopted by the United States on August 10, in response to the global shortage of monkeypox vaccines. As part of that decision released earlier this month, US Health and Human Services Secretary Xavier Becerra issued a 564 determination, granting the US Food and Drug Administration the power to issue an emergency use authorization for vaccines. This gives the FDA permission to change the way the MVA-BN vaccine, made by Danish company Bavarian Nordic, is administered. Dr Kate O’Brien, WHO Director of Immunization, Vaccines and Biologicals, Group of monkeypox experts to examine the ‘fractional’ strategy Dr. Kate O’Brien, WHO’s Director of the Department of Immunization, Vaccines and Biologicals, said a strategic advisory group of experts will meet at the beginning of October to evaluate “some of these fractional dose issues” and the evidence for and against the strategy. Known as dose sparing, the U.S. fractional dose strategy splits the approved MVA-BN vaccine that is typically administered subcutaneously into five doses from each vaccine vial, and then delivers those “intradermally” just below the outermost layer of skin, known as the epidermis. “The strategy of what’s termed using fractional doses for vaccines is not a new strategy for vaccines,” O’Brien told a virtual press briefing on Thursday. “And we are looking really carefully at the evidence for the performance of these vaccines, these smallpox monkeypox vaccines,” she said, “to look at the equivalence or in fact, possibly the improved performance using fractional doses.” Along with extending the limited vaccine supplies, the procedure is supposed to provoke a more powerful immune reaction. But the strategy announced earlier by U.S. President Joe Biden’s administration is not going according to plan, Politico reports, with those administering the vaccine saying they’re getting only three or four doses out of each vial. Other media have reported the intradermal procedure’s more frequent use on men of color who have sought the vaccine recently, while white men who got in line first for the jab were able to get a full dose in the more proven, subcutaneous manner. Another complicating factor is the requirement for health workers to get extra training for the delicate intradermal procedure. The net result is speculation that if the outbreak continues to expand in the Americas, the US may be forced to fall back on another stockpile of ACAM2000 smallpox vaccines that are highly effective but can have dangerous side effects. Chronic Disease Focus of New Strategy 25/08/2022 Paul Adepoju 72nd WHO Regional Committee for Africa Ministers and government officials took on noncommunicable diseases, sickle cell disease, health system reforms in response to the COVID-19 pandemic, and measures to fight tuberculosis among children in Africa during their meeting of the 72nd WHO Regional Committee for Africa this week. In an effort to curb Africa’s chronic disease crisis, African health ministers adopted a new regional strategy to improve the diagnosis and treatment of severe forms of NCDs in district hospitals and first level referral facilities where care is often unavailable today. The new regional strategy for NCDs is known as PEN-PLUS. It addresses cardiovascular diseases, diabetes, cancer, and chronic lung disease that are responsible for almost 70% of all premature deaths worldwide – and a fast growing proportion of premature deaths in Africa. In addition, African nations face a special burden from sickle cell disease, which can cause severe anaemia and premature death if left untreated. In Africa, mortality from NCDs increased from 24% of total premature deaths in 2000 to more than 37% as of 2019. But many African countries lack adequate capacity to diagnosis and treat NCDs at the primary health care level, and most are only equipped to treat severe NCDs at tertiary health facilities, meaning big hospitals, located in large cities. The probability of premature death (age 30-70) from NCDs. This, WHO says, puts care beyond the reach of rural and poorer patients who typically rely on district hospitals and local health centres that lack the capacity and resources to effectively manage severe NCDs. Just 36% of countries have public hospitals stocked with basic NCD medications Knowing your blood pressure supports NCD prevention, diagnosis, and early treatment. PEN-PLUS, developed by WHO in collaboration with African health ministers over the past two years, offers a roadmap for countries to institute standardised programs to tackle chronic and severe NCDs by ensuring that essential medicines, technologies and diagnostics are available and accessible at district hospitals. It also encourages African governments to improve training and treatment protocols for chronic NCDs and to ensure that people at private hospitals can access services for severe NCDs Currently, just 36% of countries in the African region have public hospitals stocked with the medicines needed to treat NCDs, and private hospitals also must provide such services, according to WHO. In Liberia, Malawi, and Rwanda, where the strategy is already deployed, WHO says there has been a significant increase in the health and numbers of patients treated for severe chronic NCDs. In Africa, the most prevalent NCDs include Type 1 and 2 Diabetes, hypertension, heart disease and asthma, as well as sickle-cell disease, a genetic disorder, according to WHO data. Related to the drive against chronic NCDs, new campaign on sickle cell disease Health ministers also launched a campaign to tackle sickle cell disease, an inherited blood disorder that causes anaemia and can shorten lifespans, if left untreated. More than 66% of the 120 million people worldwide affected by sickle cell disease live in Africa, and approximately 1,000 African children are born with the disease every day. In 2019, the number of sickle cell disease deaths in the African region rose to 38,403 — a 26% increase from 2000. This rise in disease burden is attributed to a lack of investment in disease-fighting tools including prevention, early detection and proper care, according to WHO. The level of care has also been hampered by inadequate personnel and services, particularly at lower-level facilities. The campaign aims to shore up political will, engagement and financial resources for sickle cell disease prevention and control across the region. It draws on financial support and resources from the World Bank, U.S. Department of Health and Human Services, Novartis Foundation, Global Blood Therapeutics, and the Sickle in Africa consortium. Chief targets are schools, communities, health institutions and news media outlets. WHO notes that progress on controlling the disease in Africa is hindered by the absence of newborn screening programmes and surveillance, lack of accurate and reliable data on sickle cell disease and no data collection for sickle cell disease in most national surveys. “We need to shine the spotlight on this disease and help improve the quality of life of those living with it,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. Revamping Africa’s health systems in the wake of the pandemic Dr Matshidiso Moeti, WHO Regional Director for Africa, spoke at the session on childhood tuberculosis At the meeting, countries also agreed to institute other reforms in the region’s health systems in response to the COVID-19 pandemic, placing more emphasis on improved disease surveillance, as well as prevention and vaccination. “Domestic investment in health, including health research, has significant economic returns, while promoting resilience and sustainability; healthy populations translate to healthy economies,” Moeti said. Senegal’s Health Minister, Dr Marie Khemesse Ngom Ndiaye, said that due to the pandemic, her nation’s health system put more emphasis on resilience and investment. That “considerably strengthened disease prevention and management capacities,” she said. Fighting tuberculosis among children In terms of infectious diseases, long the major focus of African health programmes, more comprehensive and immediate measures are needed to fight tuberculosis among children in Africa, said representatives of WHO and the African Union, at the meeting. Their comments were echoed by the Stop TB Partnership and the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF). Currently, two-thirds of children with TB in WHO’s African Region fail to get diagnosed for the disease, WHO says, leading to an increased risk of rapid disease progression and mortality, especially in younger children. Among children under age five believed to have TB, just 32% in the African Region are adiagnosed and treated, the smallest proportion for that age group globally. Seventeen of the world’s 30 countries with the highest tuberculosis burden globally are in Africa, where 322,000 children and young adolescents under 15 years of age are affected. Minata Samate Cessouma, Commissioner for Health, African Union “There is an urgent need for innovative interventions to integrate tuberculosis diagnosis in nutrition programs to identify the disease in children quickly,” said Minata Samate Cessouma, African Union Commissioner for Health, Humanitarian Affairs and Social Development. “Children with tuberculosis are almost never spreading the disease and are always infected by an adult,” said Dr Lucica Ditiu, Executive Director of Stop TB Partnership, “so their suffering is a metric of our failures to diagnose and treat tuberculosis in children.” A child dies of tuberculosis somewhere in the world every two minutes, even though it is curable and preventable, she noted. . Tackling Malawi’s cholera outbreak At the meeting, WHO and UNICEF also announced joint plans to ramp up efforts to contain a cholera outbreak recently announced in Malawi. The outbreak has grown to 1,483 cases and 58 deaths in the northern and central regions, where it affects lakeshore communities and crowded, urban areas with insufficient water and sanitation facilities. The UN agencies say they will increase surveillance for early detection and management; improve the quality of case management at cholera treatment units; and provide critical supplies needed to manage cholera cases. They also plan to help improve water treatment, personal hygiene and household water storage. WHO’s Country Representative for Malawi, Dr Neema Rusibamayila Kimambo, stressed that every death from cholera is preventable. The UN health agency will offer additional support to Malawi’s Health Ministry to “help ensure that lives continue to be saved and a resilient health system is maintained during and beyond the current outbreak,” Kimambo said. UNICEF Malawi’s Representative, Rudolf Schwenk, said it’s urgent to help Malawi’s already overburdened public health services and health care delivery systems. “The good news is that we know the solutions,” Schwenk said. “We are on the ground providing humanitarian assistance in the affected districts, but we need more support to further scale up our response.” Image Credits: WHO, NCD Alliance, Twitter/Matshidiso Moeti, Twitter/WHO AFRO. NEJM Study: Pfizer’s Paxlovid Reduces COVID-19 Death by 81% in Older Adults, Not Effective in Younger Patients 24/08/2022 Maayan Hoffman Pfizer’s Paxlovid, an oral antiviral, has been found to reduce the mortality rate in older adults. Pfizer’s COVID-19 oral antiviral Paxlovid was found to reduce the mortality rate among people over the age of 65 by 81% in a new Israeli study published Wednesday in the New England Journal of Medicine. However, the study also found no significant benefit of the drug in patients aged 64 and younger. It is the first peer-reviewed study on the effectiveness of the drug in real-world conditions, one of its lead researchers told Health Policy Watch. The study also differs from the Pfizer clinical trials on the drug that were conducted during the Delta wave, and on patients who were unvaccinated. The Israeli study took place during the Omicron wave, and the majority of patients had been fully vaccinated with three jabs of the Pfizer Covid-19 vaccine. The study is peer-reviewed and a fuller version of data first published in June on the Research Gate Platform. The researchers also found a 73% reduction in hospitalization rate compared to the control group. Hospitalization and Mortality Rates Paxlovid To arrive at their results, the team of researchers analyzed Clalit electronic health records of high-risk patients over the age of 40 with advanced statistical methods between 9 January and 10 March of this year. During this period, 3,902 COVID-19 patients received Paxlovid via Clalit. The researchers compared the hospitalization and mortality rates among Covid patients who took the medicine and COVID patients who did not take the medicine (the control group). The Pfizer clinical trial found that Paxlovid was 89% effective in patients at risk of serious illness, the company reported at the end of 2021. As noted, the Clalit rate of effectiveness was much lower. However, Dr Ronen Arbel, Health Outcomes Researcher at Clalit Health Services and Sapir College, told Health Policy Watch that “if you want to compare apples to apples, you have to look at the minority of patients in our study who were unvaccinated and over the age of 65. If you look at them, the effectiveness is much more similar [to the Pfizer study]. “It is when you look at the majority of the patients, while the effect is significant, it is much smaller,” he said. Clalit has distributed more Paxlovid than any other health fund in Israel, according to Dr Doron Netzer, Chief Medical Officer of Clalit’s Community Health Division. In total, some 30,000 Israelis have received the drug. In March, a Medicines Patent Pool (MPP) announced it had signed agreements with 35 companies to manufacture generic versions of Paxlovid for distribution in 95 low- and middle-income countries. But that came under fire almost immediately from medicines access groups as too little, too late. Reported Significant Reduction in Risk of Hospitalization and Death In Israel, the drug is prescribed to COVID-19 patients aged 12 and older with mild to moderate symptoms who are at high risk for complications of Covid-19. The treatment is given for five days, as close as possible to the date that a positive COVID-19 test is received. “The results if the study show unequivocally that treatment with Paxlovid significantly reduces the risk of hospitalization and death from Covid-19 in those over the age of 65,” Netzer said. “The decision of the Health Ministry to allow this treatment saved many lives.” Earlier this month, the US Food and Drug Administration called on Pfizer to test another course of Paxlovid for those who have rebounded and tested positive after an initial dose. It also requested that Pfizer hold a clinical trial to evaluate different durations of treatment in immunocompromised patients with mild-to-moderate disease, Health Policy Watch reported. Pfizer told Bloomberg News that the trial protocol is expected to be finalized this month. Arbel said that the Clalit study did not examine these questions due to limitations in its data. Image Credits: Pfizer , Bobbi-Jean MacKinnon. Health System “Shaken” by Ukraine War 24/08/2022 John Heilprin COVID-19 patient in severe state in Chernivtsi, southwestern Ukraine. As the SARS-CoV2 pandemic wanes, health services must deal with a health emergency – created solely by human forces. Six months into the Ukraine war, the World Health Organization warns that the nation’s battered but “still-resilient” health system is facing “severe challenges and shortages in many areas” that must be dealt with as the nation prepares for a challenging winter. WHO officials marked the half-year point in the war, which coincided with Ukraine’s Independence Day, with a somber reflection on the state of the nation’s life-saving health system. The UN healthy agency says Ukraine has a “badly affected but still-resilient health system” even as attacks on it continue. Since the war began with Russia’s invasion on February 24, WHO says it has verified 473 attacks carried out on health systems, including facilities and personnel, resulting in at least 98 deaths and 134 injuries. In May, the World Health Assembly approved a resolution condemning the Ukraine war by 88 votes to 12. But the 53 abstentions reflected the discomfort of many member states with a debate that polarised the global health body. Most African nations abstained, as did many Middle Eastern nations, India and Pakistan. Most of Europe, the United States, Oceania and many Latin American countries supported the Ukrainian-backed resolution, which condemns “in the strongest terms, Russian Federation’s military aggression against Ukraine, including attacks on health care facilities.” Empty hospital beds line the hallways of the Kyiv Regional Perinatal Centre, Ukraine, on 7 March 2022. As hospitals are disrupted or destroyed, online healthcare services can mitigate gaps. Health System “Shaken” by Ukraine War, But Not “Collapsed” WHO says it is supporting Ukraine’s Ministry of Health in the Ukraine war by helping to restore disrupted services, displaced health workers and destroyed infrastructure. It also helped the ministry and partners deliver more than 1300 metric tonnes of medical supplies, WHO says, including power generators, ambulances and oxygen supplies for medical facilities. The UN health agency says those deliveries also include supplies for trauma and emergency surgeries and medicines to help treat noncommunicable diseases (NCDs). “Six months of war have had a devastating impact on the health and lives of Ukraine’s people, but despite many challenges the health system has managed to survive and deliver care where and when it is needed most,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Though shaken, the health system has not collapsed,” he said. “But no system can deliver optimum health to its people under the stress of war, which is why we continue to call on the Russian Federation to end this war.” After six months of war, #Ukraine’s badly affected but still-resilient health system is taking stock of lessons learnt in providing lifesaving care as it prepares for a challenging winter ahead.@WHO and partners are ready to provide continued support.https://t.co/Ezsrc5qgGe pic.twitter.com/caTNNgXkUk — WHO Ukraine (@WHOUkraine) August 24, 2022 Ukraine War’s “Horror” Demands Mental Health Response Dr Hans Henri Kluge, WHO Regional Director for Europe, said attacks on health care violate international humanitarian law and are “unconscionable” because they kill and maim civilians and health-care providers, and severely hinder or prevent the delivery of health care services to those who needed it most. “Amid the horror of war,” he said, “we continue to witness the heroic efforts of health providers – including the many I’ve been privileged to meet in person myself – who are such a credit to their profession despite their own personal suffering.” WHO also has helped train more than 9000 health care workers. Areas of focus include trauma surgery, mass casualties, chemical exposure, epidemiology and laboratory diagnostics. But mental health, including stress management for health care workers and the public, is a priority in the Ukraine war. “WHO is stepping up its efforts with the Ministry of Health to ensure that the health workforce is prepared with the necessary skills to respond to mounting needs as winter approaches,” said Dr Jarno Habicht, WHO Representative in Ukraine. “We’re already seeing severe challenges and shortages in many areas, with rising inequalities in access to health and other essentials, impacting, as always, the most vulnerable – women, children and the elderly,” said Habicht. “Even as we look to a time when peace is restored,” he said, “we must focus on the here and now – the next six months could test Ukraine’s health system as never before.” A destroyed tank is abandoned on the road to Bucha, Ukraine. Image Credits: Mstyslav Chernov/ Wikimedia Commons, UNICEF/Oleksandr Ratushniak, Marco Frattini/ World Food Program. Pfizer Submits Reguest to US FDA for Approval of Omicron-targeted COVID Booster Shot 23/08/2022 Zachary Brennan, via Endpoints News Albert Bourla, CEO of Pfizer, at a World Economic Forum meeting in 2018. The Omicron-targeted boosters are coming. Almost 250 days since Omicron became the dominant variant in the US, Pfizer and BioNTech on Monday officially announced that they’ve requested an Emergency Use Authorization (EUA) from the US Food and Drug Administration for their booster dose of an Omicron BA.4/BA.5-adapted bivalent vaccine for those 12 and older. The application’s submission comes as BioNTech said earlier this month that it expects to begin delivering Omicron-adapted vaccines as early as October, subject to regulatory approval. The FDA’s vaccine advisory committee in late June gave the thumbs up — by a vote of 19-2 — to requiring an Omicron-related component in this season’s booster dose; both Pfizer/BioNTech and Moderna have been working on such boosters over the past few months. The EUA for Pfizer/BioNTech’s booster would be based on preclinical data showing that it generated a strong neutralizing antibody response against the BA.4/BA.5 variants, as well as safety, tolerability and immunogenicity data from a Phase II/III trial of a 30-µg booster dose of the companies’ other, Omicron BA.1-adapted bivalent vaccine candidate. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month, Pfizer and BioNTech said. FDA to Pfizer: Test another course of Paxlovid for those rebounding In other COVID-related drug developments, the FDA earlier this month quietly called on Pfizer to test another course of its Covid-19 antiviral Paxlovid for those who have rebounded and tested positive after an initial dose. On Aug. 5, the FDA reissued its EUA letter for Paxlovid to include additional post-authorization requirements, including calling on Pfizer “to conduct a clinical trial in patients with ‘COVID-19 rebound’ and a clinical trial evaluating different durations of treatment in immunocompromised patients with mild-to-moderate Covid-19.” Pfizer told Bloomberg News that it is “working with the FDA to finalize a protocol to study patients who may be in need of retreatment,” and the trial protocol is expected to be finalized this month. FDA expands Novavax EUA for teenagers Additionally, US teenagers looking for an option outside of the mRNA Covid-19 vaccines will now be able to turn to Novavax’s Covid-19 vaccine which won an expanded EUA on Friday from the FDA. Those aged 12 through 17 will gain access to the Novavax vaccine after the company submitted data from an ongoing pediatric expansion of its Phase III trial of 2,247 adolescents within that same age range across 75 sites in the US. The company said that in this population the vaccine achieved its primary efficacy endpoint, with clinical efficacy of about 78% (95% CI: 37.55%, 92.45%) overall, at a time when the Delta variant was the predominant circulating variant. The efficacy analysis was supported by assessment of antibody titers that were shown to be higher in adolescents than in young adults, Novavax added. Canada buys 12M doses of Moderna’s Omicron-targeted booster Meanwhile, mRNA powerhouse Moderna said Monday that Canada’s government has exercised its option to purchase an additional 4.5 million doses of an Omicron-containing bivalent vaccine booster candidate, in addition to moving forward the scheduled delivery of 1.5 million doses of the bivalent vaccine candidate from 2023 to 2022. Moderna and Canada also agreed to shift six million doses of the current vaccine to the Omicron-containing vaccine, subject to regulatory approval, with doses scheduled for delivery this year. The vaccine is expected to be ready for deployment in the US in October. ______________________________________________________ This article was first published by Endpoints News. Image Credits: Flickr – World Economic Forum. WHO Warns of New Ebola Threat in DRC 23/08/2022 John Heilprin A health worker in Democratic Republic of the Congo’s eastern province of North Kivu. A new case of Ebola has been confirmed in the Democratic Republic of the Congo’s eastern province of North Kivu, prompting health authorities to declare a resurgence of the deadly virus, World Health Organization (WHO) officials said on Tuesday. WHO announced that health authorities confirmed a 46-year-old woman died of the disease on 15 August in Beni, a town located in North Kivu. She initially received care for other ailments at the Beni Referral Hospital, who said, but the began exhibiting symptoms consistent with Ebola. A statement from WHO said both the Beni and Goma branches of the DRC’s National Institute of Biomedical Research (INRB) confirmed Ebola virus in samples taken from the patient. Further analysis showed her death was genetically linked to the 2018-2020 outbreak in North Kivu and Ituri provinces that was the country’s longest and largest. Last week, WHO issued its first guidelines ever for Ebola treatment. It advised using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease,” WHO says. That includes older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth. Dr Matshidiso Moeti, WHO Africa Executive Director. Battling ‘Greater Frequency’ of Resurgent Ebola Cases This latest resurgence comes just four months after the Ebola outbreak that erupted on 23 April in DRC was declared to be over by DRC and WHO authorities, with fewer cases and deaths than previous episodes due to a swift response including vaccinations. The last time the disease flared up in Beni it was brought under control in about two months and ended in mid-December 2021, after causing six deaths among eight confirmed and three probable cases. “Ebola resurgences are occurring with greater frequency in the Democratic Republic of the Congo which is concerning,” said Dr Matshidiso Moeti, World Health Organization (WHO) Regional Director for Africa. “However, health authorities in North Kivu have successfully stopped several Ebola flareups and, building on this expertise, will no doubt bring this one under control quickly,” Moeti said. Some 160 people have been identified as contacts and their health is being closely monitored by WHO staff and DRC health authorities, WHO said, and it has not yet been determined whether the woman who died was vaccinated. The nation has 1,000 doses of the rVSV-ZEBOV Ebola vaccine in its stockpile, including 200 that are being shipped to Beni this week. Ebola, which is spread by contact with the bodily fluids of an infected person or contaminated materials, produces early symptoms of fever and muscle aches like malaria. WHO’s “ring vaccination” strategy — vaccinating people who came into contact with patients — is expected to begin shortly after having shown some effectiveness at preventing new cases and limiting the spread of the disease in the DRC. WHO has been supporting DRC’s government to scale up testing, contact tracing and public health measures. Stockpiles of Ebola vaccines from the cities of Goma and Kinshasa were transported to Mbandaka earlier this year so vaccinations could start. A targeted Ebola vaccination campaign aimed at tracing and immunizing contacts was underway in Mbandaka, a city in DR Congo’s north-western Equateur Province. Image Credits: WHO. WHO Advocates Prevention Focus in Africa 23/08/2022 Paul Adepoju & John Heilprin WHO Director-General Dr Tedros Adhanom Ghebreyesus at the opening of the 72nd session of the Regional Committee for Africa African nations need to pivot to prevention in their fight against disease by “addressing its root causes” through a greater focus on improved diets, healthier environments, and better road safety, among other factors, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the 72nd WHO Regional Committee for Africa meeting, at the opening of the weeklong session of member states in Togo’s capital Lomé. Tedros also pledged WHO’s continued support for the work of the African Centers of Disease Control (Africa CDC) in remarks aimed at squelching tensions between the two agencies that emerged earlier this summer. Africa CDC began circulating a proposal for it to be empowered by the African Union to declare continental health emergencies, something WHO reportedly opposed. The Fuss Over Who Should Declare Public Health Emergencies in Africa This week’s meeting of African health ministers and government officials is supposed to focus on ways to lower the burden of disease, strengthen capacity and endorse strategies in fighting disease and promoting access to health services and people’s well-being. It also is looking at how the continent can improve prevention and battle COVID-19 and a growing number of other health challenges from outbreaks of communicable diseases, conflicts and humanitarian crises, climatic change and chronic diseases. “Realizing our vision for the highest attainable standard of health starts not in the clinic or the hospital, but in schools, streets, supermarkets, households and cities,” Tedros told the meeting. It was his first major appearance since he formally began his second five-term at the helm of the 194-nation UN health agency a week ago. “Much of the work that you do as ministries of health is dealing with the consequences of poor diets, polluted environments, unsafe roads and workplaces, inadequate health literacy, and the aggressive marketing of products that harm health,” he said. “That’s why,” Tedros said, “we are calling on all member states to make an urgent paradigm shift, towards promoting health and well-being and preventing disease by addressing its root causes, and creating the conditions for health to thrive.” Pledging support for Africa CDC and the African Medicines Agency Tedros also pledged WHO’s continued financial and technical support Africa Centers for Disease Control and Prevention (Africa CDC) – noting that he had in fact helped birth the agency with a proposal for its creation at an African Union summit in July 2013 when he was Ethiopia’s foreign minister. “So, Africa CDC is my daughter, and not only me, but WHO and our regional office, all of us, will do everything to strengthen it. The strengthen of continental institutions is very important to the advancement of health and other sectors in our continent,” he said. “In the same way,” he added, “we are also continuing to provide technical and financial support to the African Medicines Agency (AMA), to support greater regulatory capacity on the continent,” he added, of the new medicines agency that is supposed to help facilitate the more rapid and harmonized approval of new drugs and vaccines across Africa. Cessouma Minata Samate, AU’s Commissioner for Health, Humanitarian Affairs, and Social Development, at the opening ceremony of the 72nd session of the Regional Committee for Africa Last month, Health Policy Watch reported that the Executive Council of the African Union (AU) selected Rwanda to host the headquarters of the African Medicines Agency. Cessouma Minata Samate, AU’s Commissioner for Health, Humanitarian Affairs, and Social Development, said the AMA also aims to support the production of medicines on the African continent. “Through this agency, we are going to build the regulatory capacity of member states of the African Union and the regional economic community,” she said. While congratulating the government of Rwanda for being selected to host AMA’s headquarters, she urged the country to ensure the agency becomes operational as soon as possible. See our special coverage of the development of the AMA here: African Medicines Agency Countdown From prevention to battling inequity Dr Matshidiso Moeti, WHO’s Regional Director for Africa, noted the COVID-19 pandemic showed just how important it is for African countries to invest in health care and fighting diseases. In Africa last year, 22 million jobs were lost and 30 million more people were added to the ranks of extreme poverty, which is defined by the World Bank as living on less than US$1.90 a day. With things expected to continue this way into next year, she said, “these statistics make the case for investment in health very clear.” Inequity is a key factor impeding Africa’s health progress, according to Moeti, whether it is the lack of tools needed for prevention and responses to pandemics or the high out-of-pocket payments that prevent people from seeking health care when they need it. Moeti expressed continued WHO concern about the continent’s comparatively lower COVID-19 vaccination rate despite the recent availability of large quantities of doses. She said it puts health and jobs at unnecessary risk while opening the door to the emergence of new, potentially dangerous variants of the virus. “A fresh impetus to accelerate COVID-19 vaccine uptake is imperative, especially to safeguard our most vulnerable,” she said. Togo’s President Faure Gnassingbé at the opening ceremony of the 72nd session of the Regional Committee for Africa Togo eradicates four NTDs while fighting disease A highlight of the opening ceremony was the recognition of Togo’s efforts at disease prevention including the eradication of four neglected tropical diseases (NTDs). “The liberation of Togo from Dracunculiasis (Guinea-worm disease), Human African Trypanosomiasis, lymphatic filariasis and trachoma is a stunning achievement that will free many people from the threat of these devastating diseases,” Tedros said. “I also congratulate you,” he added,” “for the progress you have made in improving the management and efficiency of hospitals, and for increasing access to services for the population.” Togo’s President Faure Gnassingbé said health is at the center of his government’s development — and is a priority for social cohesion. He described Togo’s relationship with WHO as one that has transcended beyond institutional cooperation and is now a genuine partnership that supports Togo’s health systems, helping to coordinate emergency responses and to raise vaccine equity. “It is a partnership that guides us — learning from current crises with a view to sustainable, equitable and sound solutions,” he said. Image Credits: WHO. Monkeypox Vaccine: 62% of Recipients Experience No Side Effects, Says New Survey 22/08/2022 Maayan Hoffman Jynneos Monkeypox Vaccine A first-of-its-kind survey examining the side effects of the monkeypox vaccine in Israel found that the majority of recipients had no general symptoms. “Most of the side effects reported by the vaccinated are local and mild, which in most cases pass within one to three days,” said Miri Mizrahi Reuveni, Deputy CEO and Head of the Health Division at Maccabi Healthcare Services, which conducted the survey. Maccabi is one of Israel’s four major public health funds. This is some of the first data to be systematically reported on side effects of the vaccine and uptake since the outbreak began, however, the data does not reflect on the vaccine’s efficacy which will take more time to assess. Specifically, some 62% of 155 vaccine recipients reported a return to routine without any general symptoms, Maccabi reported on Monday. The other 38% experienced side effects. Among those who experienced side effects, most fell into broad categories: 27% reported weakness and fatigue; 11% complained of muscle pain; 9% had headaches; 6% suffered from diarrhea; 5% got nausea; 4% had less appetite and swelling of the lymph nodes; 3% felt chills and joint pain; 1% got a skin rash; and another 1% felt eye irritation. A majority of recipients, or 74%, experienced pain at the site of injection, including stiffness (22%), localized swelling (7%) and itching (6%). In most cases, those who experienced side effects said they lasted more than 24 hours. But 22% of recipients who had symptoms said they persist today. Only 3 percent reported that their symptoms passed in less than 24 hours. About 10% said they lasted one day; 39% said they ended within two to three days; and 19% complained of symptoms that took four to six days to resolve. Eight-five percent of respondents said they had no hesitation about getting the jab. The health fund also asked people why they decided to get vaccinated. The most common responses were a desire to protect themselves and those around them. More than a third said they also were afraid of becoming isolated. More than people who belong to the HMO have taken the vaccine already, according to Reuveni. The survey began when the country started distributing the vaccine at the start of August. Respondents were asked questions after they got the shot and seven days later. As of the end of last week, the Israeli Health Ministry reported 197 cases of monkeypox in the country, all of them involving men. Ministry officials told Health Policy Watch on Monday that so far more than 2,300 Israelis have been vaccinated against the virus. The country recently expanded its vaccination criteria to allow more people to get the shot. Israel ordered 10,000 vaccine doses, of which a little more than half have arrived. Some 4,400 vaccine doses are expected to arrive at the beginning of September, ministry officials said. The international monkeypox outbreak began on May 4 when a first case outside of historically endemic African countries was discovered in London. Since then, it has spread across the world, according to the World Health Organization (WHO), with more than 35,000 cases of monkeypox reported from 92 countries and territories accompanied by 12 deaths. WHO Monkeypox Dashboard as of 22 August 2022 Image Credits: Star919News/Twitter , WHO. Open Access 240 Compound Collection Launched in Fight Against Infectious and Mosquito-Borne Illnesses for World Mosquito Day 22/08/2022 Raisa Santos Aedes aegypti mosquito can spread Zika fever, dengue, and other diseases. To mark World Mosquito Day, 20 August, the Global Health Priority Box has been launched to provide free access to 240 compounds to stimulate research into new drugs and insecticides. The initiative, launched by the Medicines for Malaria Venture (MMV) and the Innovative Vector Control Consortium (IVCC), provides scientists with starting points to advance the development of tools that can tackle several priorities set out by the WHO in late 2021, including drug resistance and communicable diseases. Every year vector-borne diseases such as malaria cause the loss of more than 700,000 lives annually, predominantly in regions with tropical climates in low- and middle-income countries. Major vector-borne diseases account for 17% of the global burden of communicable diseases. Recent studies have shown that climate change has the potential to shift the regions in which disease-carrying mosquitoes breed, introducing new pathogens to previously unaffected areas. For example, the spread of malaria, caused by a parasite that spreads to humans and other animals through the bites of infected female mosquitoes, increases in temperatures of around 25ºC. Coupled with the increasing prevalence of drug-resistant superbugs and insecticide resistance, it is clear that new tools are needed to fight against vector-borne diseases. “Efforts to end infectious diseases will only succeed if we have the tools to treat and prevent them,” said Dr Timothy Wells, MMV’s Chief Scientific Officer. Collection of compounds for malaria, neglected and zoonotic diseases, and more The collection features 240 compounds that can be used against drug-resistant malaria, neglected and zoonotic diseases, and other diseases at risk of drug resistance. This includes: 80 compounds with confirmed activity against drug-resistant malaria. 80 compounds for screening against neglected and zoonotic diseases, and diseases at risk of drug resistance. 80 compounds that have been tested for activity against various vector species. Priority Box’s ‘open approach’ emphasizes international collaboration The Global Health Priority Box’s builds on the reaction of the scientific community to the COVID-19 pandemic, which demonstrated that international collaboration accelerates the development of new tools, diagnostics and vaccines. Its open approach invites scientists to make screening results publicly available and to publish findings in an open access journal within two years following data generation. Such an approach allows for researchers around the world to build on one another’s work, saving time and resources. “Open innovation is one of the keys to unlocking drug discovery because it allows us to tap into existing knowledge and expertise and build on it collaboratively,” said Wells. Dr Nick Hamon, CEO of IVCC, noted the need for innovation in vector control due to the increased prevalence of insecticide resistance, “which is undermining the efficacy of bed nets and indoor residual sprays, the cornerstone of malaria prevention since the turn of the century.” “Open access to new chemistry will encourage greater collaboration across the scientific community, bringing new innovators into public health and potentially more rapid development of new vector control solutions,” he said. Image Credits: Sanofi Pasteur/Flickr. WHO Recommends Two Monoclonal Antibodies for Ebola Treatment; Calls to Expand Access in Developing Countries 19/08/2022 John Heilprin A health worker dresses in protective clothing to enter the treatment unit for a suspected Ebola case at western Uganda’s Bwera General Hospital in August 2019 – during the 2018-2020 Ebola outbreak in the neighboring Democratic Republic of Congo. In its first guidelines ever for Ebola treatment, the World Health Organization (WHO) advises using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease, including older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth,” WHO says. In its launch of the recommendations, WHO also called on the global community “to increase access to these lifesaving medicines”. As relatively new therapies, monoclonal antibodies have been difficult and expensive to access in low- and middle-income countries, with 80% of their sales occuring in the US, Canada and Europe. In 2020, a consortium of research organizations, led by Wellcome Trust issued a global call to action to expand access. Yes to Ansuvimab and Inmazeb, No to ZMapp and Remdesivir Patients should receive recommended neutralizing monoclonal antibodies as soon as possible after laboratory confirmation of diagnosis, according to WHO. Its new 44-page guidelines for Ebola treatment also makes a “conditional recommendation against” the use of ZMapp and remdesivir for patients with the Ebola virus. ZMapp, a drug cocktail of antibodies developed from the tobacco plant, was the first drug to be used on an experimental basis against the Ebola virus. Initially it showed promise with rhesus monkeys, but was not fully tested on humans. During the 2014-2016 Ebola epidemic in West Africa, however, the US Food and Drug Administration (FDA) approved ZMapp’s experimental use on patients. That epidemic, the continent’s largest ever, killed more than 11,000 people out of the 28,000 people who became ill with the virus. Subsequently, ZMapp, remdesivir as well as mAb114 and REGN-EB3 were all tested against one another in a randomized controlled trial in the Democratic Republic of Congo, running in parallel to the Ebola epidemic that wracked the eastern region of the country between 2018-2020. In August 2019, however, an independent monitoring board recommended early termination of the DRC therapeutics trial due to the favorable results demonstrated by the latter two drug candidates. The board recommended that all patients be randomized to receive either REGN-EB3 or mAb114 in an extension phase. The study’s preliminary results among 499 participants showed people who got REGN-EB3 or mAb114 had a greater chance of survival than those who received ZMapp or remdesivir. Remdesivir was originally developed to treat hepatitis C before it was investigated for treating the Ebola and Marburg viruses, and then as a post-infection treatment for COVID‑19. It eventually won US and European Medicines Agency approval as a COVID-19 treatment. However, in November 2020, WHO recommended against Remdesivir use for COVID, saying there was “no evidence” it improved patient outcomes. Access remains a problem for ebola treatment In its recommendations, WHO called for greater efforts to ensure that that the drugs are “where patients need them the most: where there is an active Ebola outbreak, or where the threat of outbreaks is high or very likely.” To assist with that goal, WHO offered to support “countries, manufacturers and partners” to step up national and global efforts to increase affordability of the biotherapeutic products. “Access to these therapeutics is challenging and pricing and future supply remain unknown, especially in resource-poor areas,” WHO says in its 44-page guidelines. “Without concerted effort, access will remain limited, and it is therefore possible that this strong recommendation could exacerbate health inequity,” it says. “Therefore, given the demonstrated benefits for patients, these recommendations should act as a stimulus to engage all possible mechanisms to improve global access to these treatments.” Both Inmazeb and Ebanga were developed with significant US government support The development of both Inmazeb and Ebanga was heavily supported by the US government and other public funders. Inmazeb, which also was the first FDA-approved treatment for Ebola, is produced by the US-based Regeneron Pharmaceuticals. It was developed in response to the 2018 Ebola outbreak in the DRC with supprot from the US Biomedical Advanced Research and Development Authority (BARDA). Regeneron announced in 2020, the company will “continue to provide Inmazeb for free in response to outbreaks in the DRC through the MEURI protocol for compassionate use,” in colaboration with the WHO, the US FDA and with continuing support from BARDA. “Regeneron is actively working with nongovernmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries,” the company declared at that time. The MEURI protocol is a WHO-approved ethical framework for the use of investigational agents. Regeneron gained fame in the first year of the COVID pandemic when former President Donald Trump was treated with another antibody cocktail that it had developed against COVID, (REGEN-COV- a combination of casirivimab and imdevimab) . The cocktail was later recommended by WHO for COVID treatment. As for Ebanga, it was initially developed by the Vaccine Research Center of the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), and then licensed in 2018 by the US biotech firm, Ridgeback Biotherapeutics for further development and ultimately FDA aprpoval. “Ebanga is currently available to patients, and Ridgeback Biotherapeutics provides and distributes the treatment to patients free of charge in Ebola-stricken countries,” the company states on its website. WHO publishes invitation to drug manufacturers to share drugs for evaluation WHO says it has now published the first invitation to manufacturers of therapeutics against Ebola virus disease to share their drugs for evaluation by the WHO Prequalification Unit, a crucial step to enabling bulk procurement of new drugs by global health agencies, for communities and countries affected by Ebola. “We have seen incredible advances in both the quality and safety of clinical care during Ebola outbreaks,” said Dr Janet Diaz, lead of the clinical management unit in WHO’s Health Emergencies program. “Doing the basics well, including early diagnosis, providing optimized supportive care with the evaluation of new therapeutics under clinical trials, has transformed what is possible during Ebola outbreaks,” she said. “This is what has led to development of a new standard of care for patients. However, timely access to these lifesaving interventions has to be a priority.” WHO also says there is a need for more research and evaluation of clinical interventions because of the large number of “uncertainties” that remain including with supportive care, with our understanding and characterization of the Ebola virus disease and its longer-term consequences, with the continued inclusion of vulnerable populations such as pregnant women, newborns, children and older people in future research. Back to the DRC for More Research, Studies on Ebola treatment The clinical trials used to shape WHO’S guidelines for Ebola treatment were conducted during the Ebola outbreaks that have raged in central and west Africa over the past six years; the largest trial was conducted in the Democratic Republic of the Congo (DRC) which saw a major outbreak in 2018-2020, as well as small outbreaks since then. Ebola is a severe and too often fatal illness, and previous outbreaks and responses showed the importance of early diagnosis and treatment with optimized supportive care that includes fluid and electrolyte repletion and treatment of symptoms. “This therapeutic guide is a critical tool to fight Ebola,” said Dr Richard Kojan, co-chair of the Guideline Development Group of experts selected by WHO and President of ALIMA, The Alliance for International Medical Action. “It will help reassure the communities, health care workers and patients, that this life-threatening disease can be treated thanks to effective drugs,” said Kojan. “From now on, people infected with the Ebola virus will have a greater chance of recovering if they seek care as early as possible,” he said. “As with other infectious diseases, timeliness is key, and people should not hesitate to consult health workers as quickly as possible to ensure they receive the best care possible.” The DRC has now recorded 14 Ebola outbreaks since 1976, including six since 2018. The most recent outbreak, which began in April, was declared to be over by DRC and WHO authorities last month — with fewer cases and deaths (five) than previous episodes due to a swift response including vaccinations. Vaccinations were launched less than a week after the outbreak was declared, using an ultra-cold chain freezer in Mbandaka so vaccine doses could be stored locally and safely, and delivered effectively. That enabled 2,104 people to be vaccinated, including 1,307 frontline workers and 302 contacts. In the previous outbreak in Equateur Province from June to November 2020, 130 people were infected and 55 died. Africa’s battles with Ebola and other deadly diseases also helped prepare its health systems to deal with COVID-19. When SARS-CoV2 virus landed on the continent, the African Centres for Disease Control (CDC) reinforced its regional coordinating centers, enhanced lab capacity and unified surveillance networks. An Additional Tool for Ebola treatment Along With Clinical Care Guidance The new Ebola treatment guidelines are meant to complement clinical care guidance that outlines the optimized supportive care Ebola patients should receive including factors such as relevant tests, pain management, nutrition and co-infections. But the recommendations only apply to the Ebola virus disease caused by Ebola virus (EBOV; Zaire ebolavirus). “Advances in supportive care and therapeutics over the past decade have revolutionized the treatment of Ebola. Ebola virus disease used to be perceived as a near certain killer. However, that is no longer the case,” said Dr Robert Fowler of the University of Toronto and co-chair of the Guideline Development Group of experts selected by WHO. “Provision of best supportive medical care to patients, combined with monoclonal antibody treatment — MAb114 or REGN-EB3 — now leads to recovery for the vast majority of people,” he said. 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Chronic Disease Focus of New Strategy 25/08/2022 Paul Adepoju 72nd WHO Regional Committee for Africa Ministers and government officials took on noncommunicable diseases, sickle cell disease, health system reforms in response to the COVID-19 pandemic, and measures to fight tuberculosis among children in Africa during their meeting of the 72nd WHO Regional Committee for Africa this week. In an effort to curb Africa’s chronic disease crisis, African health ministers adopted a new regional strategy to improve the diagnosis and treatment of severe forms of NCDs in district hospitals and first level referral facilities where care is often unavailable today. The new regional strategy for NCDs is known as PEN-PLUS. It addresses cardiovascular diseases, diabetes, cancer, and chronic lung disease that are responsible for almost 70% of all premature deaths worldwide – and a fast growing proportion of premature deaths in Africa. In addition, African nations face a special burden from sickle cell disease, which can cause severe anaemia and premature death if left untreated. In Africa, mortality from NCDs increased from 24% of total premature deaths in 2000 to more than 37% as of 2019. But many African countries lack adequate capacity to diagnosis and treat NCDs at the primary health care level, and most are only equipped to treat severe NCDs at tertiary health facilities, meaning big hospitals, located in large cities. The probability of premature death (age 30-70) from NCDs. This, WHO says, puts care beyond the reach of rural and poorer patients who typically rely on district hospitals and local health centres that lack the capacity and resources to effectively manage severe NCDs. Just 36% of countries have public hospitals stocked with basic NCD medications Knowing your blood pressure supports NCD prevention, diagnosis, and early treatment. PEN-PLUS, developed by WHO in collaboration with African health ministers over the past two years, offers a roadmap for countries to institute standardised programs to tackle chronic and severe NCDs by ensuring that essential medicines, technologies and diagnostics are available and accessible at district hospitals. It also encourages African governments to improve training and treatment protocols for chronic NCDs and to ensure that people at private hospitals can access services for severe NCDs Currently, just 36% of countries in the African region have public hospitals stocked with the medicines needed to treat NCDs, and private hospitals also must provide such services, according to WHO. In Liberia, Malawi, and Rwanda, where the strategy is already deployed, WHO says there has been a significant increase in the health and numbers of patients treated for severe chronic NCDs. In Africa, the most prevalent NCDs include Type 1 and 2 Diabetes, hypertension, heart disease and asthma, as well as sickle-cell disease, a genetic disorder, according to WHO data. Related to the drive against chronic NCDs, new campaign on sickle cell disease Health ministers also launched a campaign to tackle sickle cell disease, an inherited blood disorder that causes anaemia and can shorten lifespans, if left untreated. More than 66% of the 120 million people worldwide affected by sickle cell disease live in Africa, and approximately 1,000 African children are born with the disease every day. In 2019, the number of sickle cell disease deaths in the African region rose to 38,403 — a 26% increase from 2000. This rise in disease burden is attributed to a lack of investment in disease-fighting tools including prevention, early detection and proper care, according to WHO. The level of care has also been hampered by inadequate personnel and services, particularly at lower-level facilities. The campaign aims to shore up political will, engagement and financial resources for sickle cell disease prevention and control across the region. It draws on financial support and resources from the World Bank, U.S. Department of Health and Human Services, Novartis Foundation, Global Blood Therapeutics, and the Sickle in Africa consortium. Chief targets are schools, communities, health institutions and news media outlets. WHO notes that progress on controlling the disease in Africa is hindered by the absence of newborn screening programmes and surveillance, lack of accurate and reliable data on sickle cell disease and no data collection for sickle cell disease in most national surveys. “We need to shine the spotlight on this disease and help improve the quality of life of those living with it,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. Revamping Africa’s health systems in the wake of the pandemic Dr Matshidiso Moeti, WHO Regional Director for Africa, spoke at the session on childhood tuberculosis At the meeting, countries also agreed to institute other reforms in the region’s health systems in response to the COVID-19 pandemic, placing more emphasis on improved disease surveillance, as well as prevention and vaccination. “Domestic investment in health, including health research, has significant economic returns, while promoting resilience and sustainability; healthy populations translate to healthy economies,” Moeti said. Senegal’s Health Minister, Dr Marie Khemesse Ngom Ndiaye, said that due to the pandemic, her nation’s health system put more emphasis on resilience and investment. That “considerably strengthened disease prevention and management capacities,” she said. Fighting tuberculosis among children In terms of infectious diseases, long the major focus of African health programmes, more comprehensive and immediate measures are needed to fight tuberculosis among children in Africa, said representatives of WHO and the African Union, at the meeting. Their comments were echoed by the Stop TB Partnership and the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF). Currently, two-thirds of children with TB in WHO’s African Region fail to get diagnosed for the disease, WHO says, leading to an increased risk of rapid disease progression and mortality, especially in younger children. Among children under age five believed to have TB, just 32% in the African Region are adiagnosed and treated, the smallest proportion for that age group globally. Seventeen of the world’s 30 countries with the highest tuberculosis burden globally are in Africa, where 322,000 children and young adolescents under 15 years of age are affected. Minata Samate Cessouma, Commissioner for Health, African Union “There is an urgent need for innovative interventions to integrate tuberculosis diagnosis in nutrition programs to identify the disease in children quickly,” said Minata Samate Cessouma, African Union Commissioner for Health, Humanitarian Affairs and Social Development. “Children with tuberculosis are almost never spreading the disease and are always infected by an adult,” said Dr Lucica Ditiu, Executive Director of Stop TB Partnership, “so their suffering is a metric of our failures to diagnose and treat tuberculosis in children.” A child dies of tuberculosis somewhere in the world every two minutes, even though it is curable and preventable, she noted. . Tackling Malawi’s cholera outbreak At the meeting, WHO and UNICEF also announced joint plans to ramp up efforts to contain a cholera outbreak recently announced in Malawi. The outbreak has grown to 1,483 cases and 58 deaths in the northern and central regions, where it affects lakeshore communities and crowded, urban areas with insufficient water and sanitation facilities. The UN agencies say they will increase surveillance for early detection and management; improve the quality of case management at cholera treatment units; and provide critical supplies needed to manage cholera cases. They also plan to help improve water treatment, personal hygiene and household water storage. WHO’s Country Representative for Malawi, Dr Neema Rusibamayila Kimambo, stressed that every death from cholera is preventable. The UN health agency will offer additional support to Malawi’s Health Ministry to “help ensure that lives continue to be saved and a resilient health system is maintained during and beyond the current outbreak,” Kimambo said. UNICEF Malawi’s Representative, Rudolf Schwenk, said it’s urgent to help Malawi’s already overburdened public health services and health care delivery systems. “The good news is that we know the solutions,” Schwenk said. “We are on the ground providing humanitarian assistance in the affected districts, but we need more support to further scale up our response.” Image Credits: WHO, NCD Alliance, Twitter/Matshidiso Moeti, Twitter/WHO AFRO. NEJM Study: Pfizer’s Paxlovid Reduces COVID-19 Death by 81% in Older Adults, Not Effective in Younger Patients 24/08/2022 Maayan Hoffman Pfizer’s Paxlovid, an oral antiviral, has been found to reduce the mortality rate in older adults. Pfizer’s COVID-19 oral antiviral Paxlovid was found to reduce the mortality rate among people over the age of 65 by 81% in a new Israeli study published Wednesday in the New England Journal of Medicine. However, the study also found no significant benefit of the drug in patients aged 64 and younger. It is the first peer-reviewed study on the effectiveness of the drug in real-world conditions, one of its lead researchers told Health Policy Watch. The study also differs from the Pfizer clinical trials on the drug that were conducted during the Delta wave, and on patients who were unvaccinated. The Israeli study took place during the Omicron wave, and the majority of patients had been fully vaccinated with three jabs of the Pfizer Covid-19 vaccine. The study is peer-reviewed and a fuller version of data first published in June on the Research Gate Platform. The researchers also found a 73% reduction in hospitalization rate compared to the control group. Hospitalization and Mortality Rates Paxlovid To arrive at their results, the team of researchers analyzed Clalit electronic health records of high-risk patients over the age of 40 with advanced statistical methods between 9 January and 10 March of this year. During this period, 3,902 COVID-19 patients received Paxlovid via Clalit. The researchers compared the hospitalization and mortality rates among Covid patients who took the medicine and COVID patients who did not take the medicine (the control group). The Pfizer clinical trial found that Paxlovid was 89% effective in patients at risk of serious illness, the company reported at the end of 2021. As noted, the Clalit rate of effectiveness was much lower. However, Dr Ronen Arbel, Health Outcomes Researcher at Clalit Health Services and Sapir College, told Health Policy Watch that “if you want to compare apples to apples, you have to look at the minority of patients in our study who were unvaccinated and over the age of 65. If you look at them, the effectiveness is much more similar [to the Pfizer study]. “It is when you look at the majority of the patients, while the effect is significant, it is much smaller,” he said. Clalit has distributed more Paxlovid than any other health fund in Israel, according to Dr Doron Netzer, Chief Medical Officer of Clalit’s Community Health Division. In total, some 30,000 Israelis have received the drug. In March, a Medicines Patent Pool (MPP) announced it had signed agreements with 35 companies to manufacture generic versions of Paxlovid for distribution in 95 low- and middle-income countries. But that came under fire almost immediately from medicines access groups as too little, too late. Reported Significant Reduction in Risk of Hospitalization and Death In Israel, the drug is prescribed to COVID-19 patients aged 12 and older with mild to moderate symptoms who are at high risk for complications of Covid-19. The treatment is given for five days, as close as possible to the date that a positive COVID-19 test is received. “The results if the study show unequivocally that treatment with Paxlovid significantly reduces the risk of hospitalization and death from Covid-19 in those over the age of 65,” Netzer said. “The decision of the Health Ministry to allow this treatment saved many lives.” Earlier this month, the US Food and Drug Administration called on Pfizer to test another course of Paxlovid for those who have rebounded and tested positive after an initial dose. It also requested that Pfizer hold a clinical trial to evaluate different durations of treatment in immunocompromised patients with mild-to-moderate disease, Health Policy Watch reported. Pfizer told Bloomberg News that the trial protocol is expected to be finalized this month. Arbel said that the Clalit study did not examine these questions due to limitations in its data. Image Credits: Pfizer , Bobbi-Jean MacKinnon. Health System “Shaken” by Ukraine War 24/08/2022 John Heilprin COVID-19 patient in severe state in Chernivtsi, southwestern Ukraine. As the SARS-CoV2 pandemic wanes, health services must deal with a health emergency – created solely by human forces. Six months into the Ukraine war, the World Health Organization warns that the nation’s battered but “still-resilient” health system is facing “severe challenges and shortages in many areas” that must be dealt with as the nation prepares for a challenging winter. WHO officials marked the half-year point in the war, which coincided with Ukraine’s Independence Day, with a somber reflection on the state of the nation’s life-saving health system. The UN healthy agency says Ukraine has a “badly affected but still-resilient health system” even as attacks on it continue. Since the war began with Russia’s invasion on February 24, WHO says it has verified 473 attacks carried out on health systems, including facilities and personnel, resulting in at least 98 deaths and 134 injuries. In May, the World Health Assembly approved a resolution condemning the Ukraine war by 88 votes to 12. But the 53 abstentions reflected the discomfort of many member states with a debate that polarised the global health body. Most African nations abstained, as did many Middle Eastern nations, India and Pakistan. Most of Europe, the United States, Oceania and many Latin American countries supported the Ukrainian-backed resolution, which condemns “in the strongest terms, Russian Federation’s military aggression against Ukraine, including attacks on health care facilities.” Empty hospital beds line the hallways of the Kyiv Regional Perinatal Centre, Ukraine, on 7 March 2022. As hospitals are disrupted or destroyed, online healthcare services can mitigate gaps. Health System “Shaken” by Ukraine War, But Not “Collapsed” WHO says it is supporting Ukraine’s Ministry of Health in the Ukraine war by helping to restore disrupted services, displaced health workers and destroyed infrastructure. It also helped the ministry and partners deliver more than 1300 metric tonnes of medical supplies, WHO says, including power generators, ambulances and oxygen supplies for medical facilities. The UN health agency says those deliveries also include supplies for trauma and emergency surgeries and medicines to help treat noncommunicable diseases (NCDs). “Six months of war have had a devastating impact on the health and lives of Ukraine’s people, but despite many challenges the health system has managed to survive and deliver care where and when it is needed most,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Though shaken, the health system has not collapsed,” he said. “But no system can deliver optimum health to its people under the stress of war, which is why we continue to call on the Russian Federation to end this war.” After six months of war, #Ukraine’s badly affected but still-resilient health system is taking stock of lessons learnt in providing lifesaving care as it prepares for a challenging winter ahead.@WHO and partners are ready to provide continued support.https://t.co/Ezsrc5qgGe pic.twitter.com/caTNNgXkUk — WHO Ukraine (@WHOUkraine) August 24, 2022 Ukraine War’s “Horror” Demands Mental Health Response Dr Hans Henri Kluge, WHO Regional Director for Europe, said attacks on health care violate international humanitarian law and are “unconscionable” because they kill and maim civilians and health-care providers, and severely hinder or prevent the delivery of health care services to those who needed it most. “Amid the horror of war,” he said, “we continue to witness the heroic efforts of health providers – including the many I’ve been privileged to meet in person myself – who are such a credit to their profession despite their own personal suffering.” WHO also has helped train more than 9000 health care workers. Areas of focus include trauma surgery, mass casualties, chemical exposure, epidemiology and laboratory diagnostics. But mental health, including stress management for health care workers and the public, is a priority in the Ukraine war. “WHO is stepping up its efforts with the Ministry of Health to ensure that the health workforce is prepared with the necessary skills to respond to mounting needs as winter approaches,” said Dr Jarno Habicht, WHO Representative in Ukraine. “We’re already seeing severe challenges and shortages in many areas, with rising inequalities in access to health and other essentials, impacting, as always, the most vulnerable – women, children and the elderly,” said Habicht. “Even as we look to a time when peace is restored,” he said, “we must focus on the here and now – the next six months could test Ukraine’s health system as never before.” A destroyed tank is abandoned on the road to Bucha, Ukraine. Image Credits: Mstyslav Chernov/ Wikimedia Commons, UNICEF/Oleksandr Ratushniak, Marco Frattini/ World Food Program. Pfizer Submits Reguest to US FDA for Approval of Omicron-targeted COVID Booster Shot 23/08/2022 Zachary Brennan, via Endpoints News Albert Bourla, CEO of Pfizer, at a World Economic Forum meeting in 2018. The Omicron-targeted boosters are coming. Almost 250 days since Omicron became the dominant variant in the US, Pfizer and BioNTech on Monday officially announced that they’ve requested an Emergency Use Authorization (EUA) from the US Food and Drug Administration for their booster dose of an Omicron BA.4/BA.5-adapted bivalent vaccine for those 12 and older. The application’s submission comes as BioNTech said earlier this month that it expects to begin delivering Omicron-adapted vaccines as early as October, subject to regulatory approval. The FDA’s vaccine advisory committee in late June gave the thumbs up — by a vote of 19-2 — to requiring an Omicron-related component in this season’s booster dose; both Pfizer/BioNTech and Moderna have been working on such boosters over the past few months. The EUA for Pfizer/BioNTech’s booster would be based on preclinical data showing that it generated a strong neutralizing antibody response against the BA.4/BA.5 variants, as well as safety, tolerability and immunogenicity data from a Phase II/III trial of a 30-µg booster dose of the companies’ other, Omicron BA.1-adapted bivalent vaccine candidate. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month, Pfizer and BioNTech said. FDA to Pfizer: Test another course of Paxlovid for those rebounding In other COVID-related drug developments, the FDA earlier this month quietly called on Pfizer to test another course of its Covid-19 antiviral Paxlovid for those who have rebounded and tested positive after an initial dose. On Aug. 5, the FDA reissued its EUA letter for Paxlovid to include additional post-authorization requirements, including calling on Pfizer “to conduct a clinical trial in patients with ‘COVID-19 rebound’ and a clinical trial evaluating different durations of treatment in immunocompromised patients with mild-to-moderate Covid-19.” Pfizer told Bloomberg News that it is “working with the FDA to finalize a protocol to study patients who may be in need of retreatment,” and the trial protocol is expected to be finalized this month. FDA expands Novavax EUA for teenagers Additionally, US teenagers looking for an option outside of the mRNA Covid-19 vaccines will now be able to turn to Novavax’s Covid-19 vaccine which won an expanded EUA on Friday from the FDA. Those aged 12 through 17 will gain access to the Novavax vaccine after the company submitted data from an ongoing pediatric expansion of its Phase III trial of 2,247 adolescents within that same age range across 75 sites in the US. The company said that in this population the vaccine achieved its primary efficacy endpoint, with clinical efficacy of about 78% (95% CI: 37.55%, 92.45%) overall, at a time when the Delta variant was the predominant circulating variant. The efficacy analysis was supported by assessment of antibody titers that were shown to be higher in adolescents than in young adults, Novavax added. Canada buys 12M doses of Moderna’s Omicron-targeted booster Meanwhile, mRNA powerhouse Moderna said Monday that Canada’s government has exercised its option to purchase an additional 4.5 million doses of an Omicron-containing bivalent vaccine booster candidate, in addition to moving forward the scheduled delivery of 1.5 million doses of the bivalent vaccine candidate from 2023 to 2022. Moderna and Canada also agreed to shift six million doses of the current vaccine to the Omicron-containing vaccine, subject to regulatory approval, with doses scheduled for delivery this year. The vaccine is expected to be ready for deployment in the US in October. ______________________________________________________ This article was first published by Endpoints News. Image Credits: Flickr – World Economic Forum. WHO Warns of New Ebola Threat in DRC 23/08/2022 John Heilprin A health worker in Democratic Republic of the Congo’s eastern province of North Kivu. A new case of Ebola has been confirmed in the Democratic Republic of the Congo’s eastern province of North Kivu, prompting health authorities to declare a resurgence of the deadly virus, World Health Organization (WHO) officials said on Tuesday. WHO announced that health authorities confirmed a 46-year-old woman died of the disease on 15 August in Beni, a town located in North Kivu. She initially received care for other ailments at the Beni Referral Hospital, who said, but the began exhibiting symptoms consistent with Ebola. A statement from WHO said both the Beni and Goma branches of the DRC’s National Institute of Biomedical Research (INRB) confirmed Ebola virus in samples taken from the patient. Further analysis showed her death was genetically linked to the 2018-2020 outbreak in North Kivu and Ituri provinces that was the country’s longest and largest. Last week, WHO issued its first guidelines ever for Ebola treatment. It advised using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease,” WHO says. That includes older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth. Dr Matshidiso Moeti, WHO Africa Executive Director. Battling ‘Greater Frequency’ of Resurgent Ebola Cases This latest resurgence comes just four months after the Ebola outbreak that erupted on 23 April in DRC was declared to be over by DRC and WHO authorities, with fewer cases and deaths than previous episodes due to a swift response including vaccinations. The last time the disease flared up in Beni it was brought under control in about two months and ended in mid-December 2021, after causing six deaths among eight confirmed and three probable cases. “Ebola resurgences are occurring with greater frequency in the Democratic Republic of the Congo which is concerning,” said Dr Matshidiso Moeti, World Health Organization (WHO) Regional Director for Africa. “However, health authorities in North Kivu have successfully stopped several Ebola flareups and, building on this expertise, will no doubt bring this one under control quickly,” Moeti said. Some 160 people have been identified as contacts and their health is being closely monitored by WHO staff and DRC health authorities, WHO said, and it has not yet been determined whether the woman who died was vaccinated. The nation has 1,000 doses of the rVSV-ZEBOV Ebola vaccine in its stockpile, including 200 that are being shipped to Beni this week. Ebola, which is spread by contact with the bodily fluids of an infected person or contaminated materials, produces early symptoms of fever and muscle aches like malaria. WHO’s “ring vaccination” strategy — vaccinating people who came into contact with patients — is expected to begin shortly after having shown some effectiveness at preventing new cases and limiting the spread of the disease in the DRC. WHO has been supporting DRC’s government to scale up testing, contact tracing and public health measures. Stockpiles of Ebola vaccines from the cities of Goma and Kinshasa were transported to Mbandaka earlier this year so vaccinations could start. A targeted Ebola vaccination campaign aimed at tracing and immunizing contacts was underway in Mbandaka, a city in DR Congo’s north-western Equateur Province. Image Credits: WHO. WHO Advocates Prevention Focus in Africa 23/08/2022 Paul Adepoju & John Heilprin WHO Director-General Dr Tedros Adhanom Ghebreyesus at the opening of the 72nd session of the Regional Committee for Africa African nations need to pivot to prevention in their fight against disease by “addressing its root causes” through a greater focus on improved diets, healthier environments, and better road safety, among other factors, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the 72nd WHO Regional Committee for Africa meeting, at the opening of the weeklong session of member states in Togo’s capital Lomé. Tedros also pledged WHO’s continued support for the work of the African Centers of Disease Control (Africa CDC) in remarks aimed at squelching tensions between the two agencies that emerged earlier this summer. Africa CDC began circulating a proposal for it to be empowered by the African Union to declare continental health emergencies, something WHO reportedly opposed. The Fuss Over Who Should Declare Public Health Emergencies in Africa This week’s meeting of African health ministers and government officials is supposed to focus on ways to lower the burden of disease, strengthen capacity and endorse strategies in fighting disease and promoting access to health services and people’s well-being. It also is looking at how the continent can improve prevention and battle COVID-19 and a growing number of other health challenges from outbreaks of communicable diseases, conflicts and humanitarian crises, climatic change and chronic diseases. “Realizing our vision for the highest attainable standard of health starts not in the clinic or the hospital, but in schools, streets, supermarkets, households and cities,” Tedros told the meeting. It was his first major appearance since he formally began his second five-term at the helm of the 194-nation UN health agency a week ago. “Much of the work that you do as ministries of health is dealing with the consequences of poor diets, polluted environments, unsafe roads and workplaces, inadequate health literacy, and the aggressive marketing of products that harm health,” he said. “That’s why,” Tedros said, “we are calling on all member states to make an urgent paradigm shift, towards promoting health and well-being and preventing disease by addressing its root causes, and creating the conditions for health to thrive.” Pledging support for Africa CDC and the African Medicines Agency Tedros also pledged WHO’s continued financial and technical support Africa Centers for Disease Control and Prevention (Africa CDC) – noting that he had in fact helped birth the agency with a proposal for its creation at an African Union summit in July 2013 when he was Ethiopia’s foreign minister. “So, Africa CDC is my daughter, and not only me, but WHO and our regional office, all of us, will do everything to strengthen it. The strengthen of continental institutions is very important to the advancement of health and other sectors in our continent,” he said. “In the same way,” he added, “we are also continuing to provide technical and financial support to the African Medicines Agency (AMA), to support greater regulatory capacity on the continent,” he added, of the new medicines agency that is supposed to help facilitate the more rapid and harmonized approval of new drugs and vaccines across Africa. Cessouma Minata Samate, AU’s Commissioner for Health, Humanitarian Affairs, and Social Development, at the opening ceremony of the 72nd session of the Regional Committee for Africa Last month, Health Policy Watch reported that the Executive Council of the African Union (AU) selected Rwanda to host the headquarters of the African Medicines Agency. Cessouma Minata Samate, AU’s Commissioner for Health, Humanitarian Affairs, and Social Development, said the AMA also aims to support the production of medicines on the African continent. “Through this agency, we are going to build the regulatory capacity of member states of the African Union and the regional economic community,” she said. While congratulating the government of Rwanda for being selected to host AMA’s headquarters, she urged the country to ensure the agency becomes operational as soon as possible. See our special coverage of the development of the AMA here: African Medicines Agency Countdown From prevention to battling inequity Dr Matshidiso Moeti, WHO’s Regional Director for Africa, noted the COVID-19 pandemic showed just how important it is for African countries to invest in health care and fighting diseases. In Africa last year, 22 million jobs were lost and 30 million more people were added to the ranks of extreme poverty, which is defined by the World Bank as living on less than US$1.90 a day. With things expected to continue this way into next year, she said, “these statistics make the case for investment in health very clear.” Inequity is a key factor impeding Africa’s health progress, according to Moeti, whether it is the lack of tools needed for prevention and responses to pandemics or the high out-of-pocket payments that prevent people from seeking health care when they need it. Moeti expressed continued WHO concern about the continent’s comparatively lower COVID-19 vaccination rate despite the recent availability of large quantities of doses. She said it puts health and jobs at unnecessary risk while opening the door to the emergence of new, potentially dangerous variants of the virus. “A fresh impetus to accelerate COVID-19 vaccine uptake is imperative, especially to safeguard our most vulnerable,” she said. Togo’s President Faure Gnassingbé at the opening ceremony of the 72nd session of the Regional Committee for Africa Togo eradicates four NTDs while fighting disease A highlight of the opening ceremony was the recognition of Togo’s efforts at disease prevention including the eradication of four neglected tropical diseases (NTDs). “The liberation of Togo from Dracunculiasis (Guinea-worm disease), Human African Trypanosomiasis, lymphatic filariasis and trachoma is a stunning achievement that will free many people from the threat of these devastating diseases,” Tedros said. “I also congratulate you,” he added,” “for the progress you have made in improving the management and efficiency of hospitals, and for increasing access to services for the population.” Togo’s President Faure Gnassingbé said health is at the center of his government’s development — and is a priority for social cohesion. He described Togo’s relationship with WHO as one that has transcended beyond institutional cooperation and is now a genuine partnership that supports Togo’s health systems, helping to coordinate emergency responses and to raise vaccine equity. “It is a partnership that guides us — learning from current crises with a view to sustainable, equitable and sound solutions,” he said. Image Credits: WHO. Monkeypox Vaccine: 62% of Recipients Experience No Side Effects, Says New Survey 22/08/2022 Maayan Hoffman Jynneos Monkeypox Vaccine A first-of-its-kind survey examining the side effects of the monkeypox vaccine in Israel found that the majority of recipients had no general symptoms. “Most of the side effects reported by the vaccinated are local and mild, which in most cases pass within one to three days,” said Miri Mizrahi Reuveni, Deputy CEO and Head of the Health Division at Maccabi Healthcare Services, which conducted the survey. Maccabi is one of Israel’s four major public health funds. This is some of the first data to be systematically reported on side effects of the vaccine and uptake since the outbreak began, however, the data does not reflect on the vaccine’s efficacy which will take more time to assess. Specifically, some 62% of 155 vaccine recipients reported a return to routine without any general symptoms, Maccabi reported on Monday. The other 38% experienced side effects. Among those who experienced side effects, most fell into broad categories: 27% reported weakness and fatigue; 11% complained of muscle pain; 9% had headaches; 6% suffered from diarrhea; 5% got nausea; 4% had less appetite and swelling of the lymph nodes; 3% felt chills and joint pain; 1% got a skin rash; and another 1% felt eye irritation. A majority of recipients, or 74%, experienced pain at the site of injection, including stiffness (22%), localized swelling (7%) and itching (6%). In most cases, those who experienced side effects said they lasted more than 24 hours. But 22% of recipients who had symptoms said they persist today. Only 3 percent reported that their symptoms passed in less than 24 hours. About 10% said they lasted one day; 39% said they ended within two to three days; and 19% complained of symptoms that took four to six days to resolve. Eight-five percent of respondents said they had no hesitation about getting the jab. The health fund also asked people why they decided to get vaccinated. The most common responses were a desire to protect themselves and those around them. More than a third said they also were afraid of becoming isolated. More than people who belong to the HMO have taken the vaccine already, according to Reuveni. The survey began when the country started distributing the vaccine at the start of August. Respondents were asked questions after they got the shot and seven days later. As of the end of last week, the Israeli Health Ministry reported 197 cases of monkeypox in the country, all of them involving men. Ministry officials told Health Policy Watch on Monday that so far more than 2,300 Israelis have been vaccinated against the virus. The country recently expanded its vaccination criteria to allow more people to get the shot. Israel ordered 10,000 vaccine doses, of which a little more than half have arrived. Some 4,400 vaccine doses are expected to arrive at the beginning of September, ministry officials said. The international monkeypox outbreak began on May 4 when a first case outside of historically endemic African countries was discovered in London. Since then, it has spread across the world, according to the World Health Organization (WHO), with more than 35,000 cases of monkeypox reported from 92 countries and territories accompanied by 12 deaths. WHO Monkeypox Dashboard as of 22 August 2022 Image Credits: Star919News/Twitter , WHO. Open Access 240 Compound Collection Launched in Fight Against Infectious and Mosquito-Borne Illnesses for World Mosquito Day 22/08/2022 Raisa Santos Aedes aegypti mosquito can spread Zika fever, dengue, and other diseases. To mark World Mosquito Day, 20 August, the Global Health Priority Box has been launched to provide free access to 240 compounds to stimulate research into new drugs and insecticides. The initiative, launched by the Medicines for Malaria Venture (MMV) and the Innovative Vector Control Consortium (IVCC), provides scientists with starting points to advance the development of tools that can tackle several priorities set out by the WHO in late 2021, including drug resistance and communicable diseases. Every year vector-borne diseases such as malaria cause the loss of more than 700,000 lives annually, predominantly in regions with tropical climates in low- and middle-income countries. Major vector-borne diseases account for 17% of the global burden of communicable diseases. Recent studies have shown that climate change has the potential to shift the regions in which disease-carrying mosquitoes breed, introducing new pathogens to previously unaffected areas. For example, the spread of malaria, caused by a parasite that spreads to humans and other animals through the bites of infected female mosquitoes, increases in temperatures of around 25ºC. Coupled with the increasing prevalence of drug-resistant superbugs and insecticide resistance, it is clear that new tools are needed to fight against vector-borne diseases. “Efforts to end infectious diseases will only succeed if we have the tools to treat and prevent them,” said Dr Timothy Wells, MMV’s Chief Scientific Officer. Collection of compounds for malaria, neglected and zoonotic diseases, and more The collection features 240 compounds that can be used against drug-resistant malaria, neglected and zoonotic diseases, and other diseases at risk of drug resistance. This includes: 80 compounds with confirmed activity against drug-resistant malaria. 80 compounds for screening against neglected and zoonotic diseases, and diseases at risk of drug resistance. 80 compounds that have been tested for activity against various vector species. Priority Box’s ‘open approach’ emphasizes international collaboration The Global Health Priority Box’s builds on the reaction of the scientific community to the COVID-19 pandemic, which demonstrated that international collaboration accelerates the development of new tools, diagnostics and vaccines. Its open approach invites scientists to make screening results publicly available and to publish findings in an open access journal within two years following data generation. Such an approach allows for researchers around the world to build on one another’s work, saving time and resources. “Open innovation is one of the keys to unlocking drug discovery because it allows us to tap into existing knowledge and expertise and build on it collaboratively,” said Wells. Dr Nick Hamon, CEO of IVCC, noted the need for innovation in vector control due to the increased prevalence of insecticide resistance, “which is undermining the efficacy of bed nets and indoor residual sprays, the cornerstone of malaria prevention since the turn of the century.” “Open access to new chemistry will encourage greater collaboration across the scientific community, bringing new innovators into public health and potentially more rapid development of new vector control solutions,” he said. Image Credits: Sanofi Pasteur/Flickr. WHO Recommends Two Monoclonal Antibodies for Ebola Treatment; Calls to Expand Access in Developing Countries 19/08/2022 John Heilprin A health worker dresses in protective clothing to enter the treatment unit for a suspected Ebola case at western Uganda’s Bwera General Hospital in August 2019 – during the 2018-2020 Ebola outbreak in the neighboring Democratic Republic of Congo. In its first guidelines ever for Ebola treatment, the World Health Organization (WHO) advises using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease, including older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth,” WHO says. In its launch of the recommendations, WHO also called on the global community “to increase access to these lifesaving medicines”. As relatively new therapies, monoclonal antibodies have been difficult and expensive to access in low- and middle-income countries, with 80% of their sales occuring in the US, Canada and Europe. In 2020, a consortium of research organizations, led by Wellcome Trust issued a global call to action to expand access. Yes to Ansuvimab and Inmazeb, No to ZMapp and Remdesivir Patients should receive recommended neutralizing monoclonal antibodies as soon as possible after laboratory confirmation of diagnosis, according to WHO. Its new 44-page guidelines for Ebola treatment also makes a “conditional recommendation against” the use of ZMapp and remdesivir for patients with the Ebola virus. ZMapp, a drug cocktail of antibodies developed from the tobacco plant, was the first drug to be used on an experimental basis against the Ebola virus. Initially it showed promise with rhesus monkeys, but was not fully tested on humans. During the 2014-2016 Ebola epidemic in West Africa, however, the US Food and Drug Administration (FDA) approved ZMapp’s experimental use on patients. That epidemic, the continent’s largest ever, killed more than 11,000 people out of the 28,000 people who became ill with the virus. Subsequently, ZMapp, remdesivir as well as mAb114 and REGN-EB3 were all tested against one another in a randomized controlled trial in the Democratic Republic of Congo, running in parallel to the Ebola epidemic that wracked the eastern region of the country between 2018-2020. In August 2019, however, an independent monitoring board recommended early termination of the DRC therapeutics trial due to the favorable results demonstrated by the latter two drug candidates. The board recommended that all patients be randomized to receive either REGN-EB3 or mAb114 in an extension phase. The study’s preliminary results among 499 participants showed people who got REGN-EB3 or mAb114 had a greater chance of survival than those who received ZMapp or remdesivir. Remdesivir was originally developed to treat hepatitis C before it was investigated for treating the Ebola and Marburg viruses, and then as a post-infection treatment for COVID‑19. It eventually won US and European Medicines Agency approval as a COVID-19 treatment. However, in November 2020, WHO recommended against Remdesivir use for COVID, saying there was “no evidence” it improved patient outcomes. Access remains a problem for ebola treatment In its recommendations, WHO called for greater efforts to ensure that that the drugs are “where patients need them the most: where there is an active Ebola outbreak, or where the threat of outbreaks is high or very likely.” To assist with that goal, WHO offered to support “countries, manufacturers and partners” to step up national and global efforts to increase affordability of the biotherapeutic products. “Access to these therapeutics is challenging and pricing and future supply remain unknown, especially in resource-poor areas,” WHO says in its 44-page guidelines. “Without concerted effort, access will remain limited, and it is therefore possible that this strong recommendation could exacerbate health inequity,” it says. “Therefore, given the demonstrated benefits for patients, these recommendations should act as a stimulus to engage all possible mechanisms to improve global access to these treatments.” Both Inmazeb and Ebanga were developed with significant US government support The development of both Inmazeb and Ebanga was heavily supported by the US government and other public funders. Inmazeb, which also was the first FDA-approved treatment for Ebola, is produced by the US-based Regeneron Pharmaceuticals. It was developed in response to the 2018 Ebola outbreak in the DRC with supprot from the US Biomedical Advanced Research and Development Authority (BARDA). Regeneron announced in 2020, the company will “continue to provide Inmazeb for free in response to outbreaks in the DRC through the MEURI protocol for compassionate use,” in colaboration with the WHO, the US FDA and with continuing support from BARDA. “Regeneron is actively working with nongovernmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries,” the company declared at that time. The MEURI protocol is a WHO-approved ethical framework for the use of investigational agents. Regeneron gained fame in the first year of the COVID pandemic when former President Donald Trump was treated with another antibody cocktail that it had developed against COVID, (REGEN-COV- a combination of casirivimab and imdevimab) . The cocktail was later recommended by WHO for COVID treatment. As for Ebanga, it was initially developed by the Vaccine Research Center of the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), and then licensed in 2018 by the US biotech firm, Ridgeback Biotherapeutics for further development and ultimately FDA aprpoval. “Ebanga is currently available to patients, and Ridgeback Biotherapeutics provides and distributes the treatment to patients free of charge in Ebola-stricken countries,” the company states on its website. WHO publishes invitation to drug manufacturers to share drugs for evaluation WHO says it has now published the first invitation to manufacturers of therapeutics against Ebola virus disease to share their drugs for evaluation by the WHO Prequalification Unit, a crucial step to enabling bulk procurement of new drugs by global health agencies, for communities and countries affected by Ebola. “We have seen incredible advances in both the quality and safety of clinical care during Ebola outbreaks,” said Dr Janet Diaz, lead of the clinical management unit in WHO’s Health Emergencies program. “Doing the basics well, including early diagnosis, providing optimized supportive care with the evaluation of new therapeutics under clinical trials, has transformed what is possible during Ebola outbreaks,” she said. “This is what has led to development of a new standard of care for patients. However, timely access to these lifesaving interventions has to be a priority.” WHO also says there is a need for more research and evaluation of clinical interventions because of the large number of “uncertainties” that remain including with supportive care, with our understanding and characterization of the Ebola virus disease and its longer-term consequences, with the continued inclusion of vulnerable populations such as pregnant women, newborns, children and older people in future research. Back to the DRC for More Research, Studies on Ebola treatment The clinical trials used to shape WHO’S guidelines for Ebola treatment were conducted during the Ebola outbreaks that have raged in central and west Africa over the past six years; the largest trial was conducted in the Democratic Republic of the Congo (DRC) which saw a major outbreak in 2018-2020, as well as small outbreaks since then. Ebola is a severe and too often fatal illness, and previous outbreaks and responses showed the importance of early diagnosis and treatment with optimized supportive care that includes fluid and electrolyte repletion and treatment of symptoms. “This therapeutic guide is a critical tool to fight Ebola,” said Dr Richard Kojan, co-chair of the Guideline Development Group of experts selected by WHO and President of ALIMA, The Alliance for International Medical Action. “It will help reassure the communities, health care workers and patients, that this life-threatening disease can be treated thanks to effective drugs,” said Kojan. “From now on, people infected with the Ebola virus will have a greater chance of recovering if they seek care as early as possible,” he said. “As with other infectious diseases, timeliness is key, and people should not hesitate to consult health workers as quickly as possible to ensure they receive the best care possible.” The DRC has now recorded 14 Ebola outbreaks since 1976, including six since 2018. The most recent outbreak, which began in April, was declared to be over by DRC and WHO authorities last month — with fewer cases and deaths (five) than previous episodes due to a swift response including vaccinations. Vaccinations were launched less than a week after the outbreak was declared, using an ultra-cold chain freezer in Mbandaka so vaccine doses could be stored locally and safely, and delivered effectively. That enabled 2,104 people to be vaccinated, including 1,307 frontline workers and 302 contacts. In the previous outbreak in Equateur Province from June to November 2020, 130 people were infected and 55 died. Africa’s battles with Ebola and other deadly diseases also helped prepare its health systems to deal with COVID-19. When SARS-CoV2 virus landed on the continent, the African Centres for Disease Control (CDC) reinforced its regional coordinating centers, enhanced lab capacity and unified surveillance networks. An Additional Tool for Ebola treatment Along With Clinical Care Guidance The new Ebola treatment guidelines are meant to complement clinical care guidance that outlines the optimized supportive care Ebola patients should receive including factors such as relevant tests, pain management, nutrition and co-infections. But the recommendations only apply to the Ebola virus disease caused by Ebola virus (EBOV; Zaire ebolavirus). “Advances in supportive care and therapeutics over the past decade have revolutionized the treatment of Ebola. Ebola virus disease used to be perceived as a near certain killer. However, that is no longer the case,” said Dr Robert Fowler of the University of Toronto and co-chair of the Guideline Development Group of experts selected by WHO. “Provision of best supportive medical care to patients, combined with monoclonal antibody treatment — MAb114 or REGN-EB3 — now leads to recovery for the vast majority of people,” he said. 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NEJM Study: Pfizer’s Paxlovid Reduces COVID-19 Death by 81% in Older Adults, Not Effective in Younger Patients 24/08/2022 Maayan Hoffman Pfizer’s Paxlovid, an oral antiviral, has been found to reduce the mortality rate in older adults. Pfizer’s COVID-19 oral antiviral Paxlovid was found to reduce the mortality rate among people over the age of 65 by 81% in a new Israeli study published Wednesday in the New England Journal of Medicine. However, the study also found no significant benefit of the drug in patients aged 64 and younger. It is the first peer-reviewed study on the effectiveness of the drug in real-world conditions, one of its lead researchers told Health Policy Watch. The study also differs from the Pfizer clinical trials on the drug that were conducted during the Delta wave, and on patients who were unvaccinated. The Israeli study took place during the Omicron wave, and the majority of patients had been fully vaccinated with three jabs of the Pfizer Covid-19 vaccine. The study is peer-reviewed and a fuller version of data first published in June on the Research Gate Platform. The researchers also found a 73% reduction in hospitalization rate compared to the control group. Hospitalization and Mortality Rates Paxlovid To arrive at their results, the team of researchers analyzed Clalit electronic health records of high-risk patients over the age of 40 with advanced statistical methods between 9 January and 10 March of this year. During this period, 3,902 COVID-19 patients received Paxlovid via Clalit. The researchers compared the hospitalization and mortality rates among Covid patients who took the medicine and COVID patients who did not take the medicine (the control group). The Pfizer clinical trial found that Paxlovid was 89% effective in patients at risk of serious illness, the company reported at the end of 2021. As noted, the Clalit rate of effectiveness was much lower. However, Dr Ronen Arbel, Health Outcomes Researcher at Clalit Health Services and Sapir College, told Health Policy Watch that “if you want to compare apples to apples, you have to look at the minority of patients in our study who were unvaccinated and over the age of 65. If you look at them, the effectiveness is much more similar [to the Pfizer study]. “It is when you look at the majority of the patients, while the effect is significant, it is much smaller,” he said. Clalit has distributed more Paxlovid than any other health fund in Israel, according to Dr Doron Netzer, Chief Medical Officer of Clalit’s Community Health Division. In total, some 30,000 Israelis have received the drug. In March, a Medicines Patent Pool (MPP) announced it had signed agreements with 35 companies to manufacture generic versions of Paxlovid for distribution in 95 low- and middle-income countries. But that came under fire almost immediately from medicines access groups as too little, too late. Reported Significant Reduction in Risk of Hospitalization and Death In Israel, the drug is prescribed to COVID-19 patients aged 12 and older with mild to moderate symptoms who are at high risk for complications of Covid-19. The treatment is given for five days, as close as possible to the date that a positive COVID-19 test is received. “The results if the study show unequivocally that treatment with Paxlovid significantly reduces the risk of hospitalization and death from Covid-19 in those over the age of 65,” Netzer said. “The decision of the Health Ministry to allow this treatment saved many lives.” Earlier this month, the US Food and Drug Administration called on Pfizer to test another course of Paxlovid for those who have rebounded and tested positive after an initial dose. It also requested that Pfizer hold a clinical trial to evaluate different durations of treatment in immunocompromised patients with mild-to-moderate disease, Health Policy Watch reported. Pfizer told Bloomberg News that the trial protocol is expected to be finalized this month. Arbel said that the Clalit study did not examine these questions due to limitations in its data. Image Credits: Pfizer , Bobbi-Jean MacKinnon. Health System “Shaken” by Ukraine War 24/08/2022 John Heilprin COVID-19 patient in severe state in Chernivtsi, southwestern Ukraine. As the SARS-CoV2 pandemic wanes, health services must deal with a health emergency – created solely by human forces. Six months into the Ukraine war, the World Health Organization warns that the nation’s battered but “still-resilient” health system is facing “severe challenges and shortages in many areas” that must be dealt with as the nation prepares for a challenging winter. WHO officials marked the half-year point in the war, which coincided with Ukraine’s Independence Day, with a somber reflection on the state of the nation’s life-saving health system. The UN healthy agency says Ukraine has a “badly affected but still-resilient health system” even as attacks on it continue. Since the war began with Russia’s invasion on February 24, WHO says it has verified 473 attacks carried out on health systems, including facilities and personnel, resulting in at least 98 deaths and 134 injuries. In May, the World Health Assembly approved a resolution condemning the Ukraine war by 88 votes to 12. But the 53 abstentions reflected the discomfort of many member states with a debate that polarised the global health body. Most African nations abstained, as did many Middle Eastern nations, India and Pakistan. Most of Europe, the United States, Oceania and many Latin American countries supported the Ukrainian-backed resolution, which condemns “in the strongest terms, Russian Federation’s military aggression against Ukraine, including attacks on health care facilities.” Empty hospital beds line the hallways of the Kyiv Regional Perinatal Centre, Ukraine, on 7 March 2022. As hospitals are disrupted or destroyed, online healthcare services can mitigate gaps. Health System “Shaken” by Ukraine War, But Not “Collapsed” WHO says it is supporting Ukraine’s Ministry of Health in the Ukraine war by helping to restore disrupted services, displaced health workers and destroyed infrastructure. It also helped the ministry and partners deliver more than 1300 metric tonnes of medical supplies, WHO says, including power generators, ambulances and oxygen supplies for medical facilities. The UN health agency says those deliveries also include supplies for trauma and emergency surgeries and medicines to help treat noncommunicable diseases (NCDs). “Six months of war have had a devastating impact on the health and lives of Ukraine’s people, but despite many challenges the health system has managed to survive and deliver care where and when it is needed most,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Though shaken, the health system has not collapsed,” he said. “But no system can deliver optimum health to its people under the stress of war, which is why we continue to call on the Russian Federation to end this war.” After six months of war, #Ukraine’s badly affected but still-resilient health system is taking stock of lessons learnt in providing lifesaving care as it prepares for a challenging winter ahead.@WHO and partners are ready to provide continued support.https://t.co/Ezsrc5qgGe pic.twitter.com/caTNNgXkUk — WHO Ukraine (@WHOUkraine) August 24, 2022 Ukraine War’s “Horror” Demands Mental Health Response Dr Hans Henri Kluge, WHO Regional Director for Europe, said attacks on health care violate international humanitarian law and are “unconscionable” because they kill and maim civilians and health-care providers, and severely hinder or prevent the delivery of health care services to those who needed it most. “Amid the horror of war,” he said, “we continue to witness the heroic efforts of health providers – including the many I’ve been privileged to meet in person myself – who are such a credit to their profession despite their own personal suffering.” WHO also has helped train more than 9000 health care workers. Areas of focus include trauma surgery, mass casualties, chemical exposure, epidemiology and laboratory diagnostics. But mental health, including stress management for health care workers and the public, is a priority in the Ukraine war. “WHO is stepping up its efforts with the Ministry of Health to ensure that the health workforce is prepared with the necessary skills to respond to mounting needs as winter approaches,” said Dr Jarno Habicht, WHO Representative in Ukraine. “We’re already seeing severe challenges and shortages in many areas, with rising inequalities in access to health and other essentials, impacting, as always, the most vulnerable – women, children and the elderly,” said Habicht. “Even as we look to a time when peace is restored,” he said, “we must focus on the here and now – the next six months could test Ukraine’s health system as never before.” A destroyed tank is abandoned on the road to Bucha, Ukraine. Image Credits: Mstyslav Chernov/ Wikimedia Commons, UNICEF/Oleksandr Ratushniak, Marco Frattini/ World Food Program. Pfizer Submits Reguest to US FDA for Approval of Omicron-targeted COVID Booster Shot 23/08/2022 Zachary Brennan, via Endpoints News Albert Bourla, CEO of Pfizer, at a World Economic Forum meeting in 2018. The Omicron-targeted boosters are coming. Almost 250 days since Omicron became the dominant variant in the US, Pfizer and BioNTech on Monday officially announced that they’ve requested an Emergency Use Authorization (EUA) from the US Food and Drug Administration for their booster dose of an Omicron BA.4/BA.5-adapted bivalent vaccine for those 12 and older. The application’s submission comes as BioNTech said earlier this month that it expects to begin delivering Omicron-adapted vaccines as early as October, subject to regulatory approval. The FDA’s vaccine advisory committee in late June gave the thumbs up — by a vote of 19-2 — to requiring an Omicron-related component in this season’s booster dose; both Pfizer/BioNTech and Moderna have been working on such boosters over the past few months. The EUA for Pfizer/BioNTech’s booster would be based on preclinical data showing that it generated a strong neutralizing antibody response against the BA.4/BA.5 variants, as well as safety, tolerability and immunogenicity data from a Phase II/III trial of a 30-µg booster dose of the companies’ other, Omicron BA.1-adapted bivalent vaccine candidate. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month, Pfizer and BioNTech said. FDA to Pfizer: Test another course of Paxlovid for those rebounding In other COVID-related drug developments, the FDA earlier this month quietly called on Pfizer to test another course of its Covid-19 antiviral Paxlovid for those who have rebounded and tested positive after an initial dose. On Aug. 5, the FDA reissued its EUA letter for Paxlovid to include additional post-authorization requirements, including calling on Pfizer “to conduct a clinical trial in patients with ‘COVID-19 rebound’ and a clinical trial evaluating different durations of treatment in immunocompromised patients with mild-to-moderate Covid-19.” Pfizer told Bloomberg News that it is “working with the FDA to finalize a protocol to study patients who may be in need of retreatment,” and the trial protocol is expected to be finalized this month. FDA expands Novavax EUA for teenagers Additionally, US teenagers looking for an option outside of the mRNA Covid-19 vaccines will now be able to turn to Novavax’s Covid-19 vaccine which won an expanded EUA on Friday from the FDA. Those aged 12 through 17 will gain access to the Novavax vaccine after the company submitted data from an ongoing pediatric expansion of its Phase III trial of 2,247 adolescents within that same age range across 75 sites in the US. The company said that in this population the vaccine achieved its primary efficacy endpoint, with clinical efficacy of about 78% (95% CI: 37.55%, 92.45%) overall, at a time when the Delta variant was the predominant circulating variant. The efficacy analysis was supported by assessment of antibody titers that were shown to be higher in adolescents than in young adults, Novavax added. Canada buys 12M doses of Moderna’s Omicron-targeted booster Meanwhile, mRNA powerhouse Moderna said Monday that Canada’s government has exercised its option to purchase an additional 4.5 million doses of an Omicron-containing bivalent vaccine booster candidate, in addition to moving forward the scheduled delivery of 1.5 million doses of the bivalent vaccine candidate from 2023 to 2022. Moderna and Canada also agreed to shift six million doses of the current vaccine to the Omicron-containing vaccine, subject to regulatory approval, with doses scheduled for delivery this year. The vaccine is expected to be ready for deployment in the US in October. ______________________________________________________ This article was first published by Endpoints News. Image Credits: Flickr – World Economic Forum. WHO Warns of New Ebola Threat in DRC 23/08/2022 John Heilprin A health worker in Democratic Republic of the Congo’s eastern province of North Kivu. A new case of Ebola has been confirmed in the Democratic Republic of the Congo’s eastern province of North Kivu, prompting health authorities to declare a resurgence of the deadly virus, World Health Organization (WHO) officials said on Tuesday. WHO announced that health authorities confirmed a 46-year-old woman died of the disease on 15 August in Beni, a town located in North Kivu. She initially received care for other ailments at the Beni Referral Hospital, who said, but the began exhibiting symptoms consistent with Ebola. A statement from WHO said both the Beni and Goma branches of the DRC’s National Institute of Biomedical Research (INRB) confirmed Ebola virus in samples taken from the patient. Further analysis showed her death was genetically linked to the 2018-2020 outbreak in North Kivu and Ituri provinces that was the country’s longest and largest. Last week, WHO issued its first guidelines ever for Ebola treatment. It advised using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease,” WHO says. That includes older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth. Dr Matshidiso Moeti, WHO Africa Executive Director. Battling ‘Greater Frequency’ of Resurgent Ebola Cases This latest resurgence comes just four months after the Ebola outbreak that erupted on 23 April in DRC was declared to be over by DRC and WHO authorities, with fewer cases and deaths than previous episodes due to a swift response including vaccinations. The last time the disease flared up in Beni it was brought under control in about two months and ended in mid-December 2021, after causing six deaths among eight confirmed and three probable cases. “Ebola resurgences are occurring with greater frequency in the Democratic Republic of the Congo which is concerning,” said Dr Matshidiso Moeti, World Health Organization (WHO) Regional Director for Africa. “However, health authorities in North Kivu have successfully stopped several Ebola flareups and, building on this expertise, will no doubt bring this one under control quickly,” Moeti said. Some 160 people have been identified as contacts and their health is being closely monitored by WHO staff and DRC health authorities, WHO said, and it has not yet been determined whether the woman who died was vaccinated. The nation has 1,000 doses of the rVSV-ZEBOV Ebola vaccine in its stockpile, including 200 that are being shipped to Beni this week. Ebola, which is spread by contact with the bodily fluids of an infected person or contaminated materials, produces early symptoms of fever and muscle aches like malaria. WHO’s “ring vaccination” strategy — vaccinating people who came into contact with patients — is expected to begin shortly after having shown some effectiveness at preventing new cases and limiting the spread of the disease in the DRC. WHO has been supporting DRC’s government to scale up testing, contact tracing and public health measures. Stockpiles of Ebola vaccines from the cities of Goma and Kinshasa were transported to Mbandaka earlier this year so vaccinations could start. A targeted Ebola vaccination campaign aimed at tracing and immunizing contacts was underway in Mbandaka, a city in DR Congo’s north-western Equateur Province. Image Credits: WHO. WHO Advocates Prevention Focus in Africa 23/08/2022 Paul Adepoju & John Heilprin WHO Director-General Dr Tedros Adhanom Ghebreyesus at the opening of the 72nd session of the Regional Committee for Africa African nations need to pivot to prevention in their fight against disease by “addressing its root causes” through a greater focus on improved diets, healthier environments, and better road safety, among other factors, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the 72nd WHO Regional Committee for Africa meeting, at the opening of the weeklong session of member states in Togo’s capital Lomé. Tedros also pledged WHO’s continued support for the work of the African Centers of Disease Control (Africa CDC) in remarks aimed at squelching tensions between the two agencies that emerged earlier this summer. Africa CDC began circulating a proposal for it to be empowered by the African Union to declare continental health emergencies, something WHO reportedly opposed. The Fuss Over Who Should Declare Public Health Emergencies in Africa This week’s meeting of African health ministers and government officials is supposed to focus on ways to lower the burden of disease, strengthen capacity and endorse strategies in fighting disease and promoting access to health services and people’s well-being. It also is looking at how the continent can improve prevention and battle COVID-19 and a growing number of other health challenges from outbreaks of communicable diseases, conflicts and humanitarian crises, climatic change and chronic diseases. “Realizing our vision for the highest attainable standard of health starts not in the clinic or the hospital, but in schools, streets, supermarkets, households and cities,” Tedros told the meeting. It was his first major appearance since he formally began his second five-term at the helm of the 194-nation UN health agency a week ago. “Much of the work that you do as ministries of health is dealing with the consequences of poor diets, polluted environments, unsafe roads and workplaces, inadequate health literacy, and the aggressive marketing of products that harm health,” he said. “That’s why,” Tedros said, “we are calling on all member states to make an urgent paradigm shift, towards promoting health and well-being and preventing disease by addressing its root causes, and creating the conditions for health to thrive.” Pledging support for Africa CDC and the African Medicines Agency Tedros also pledged WHO’s continued financial and technical support Africa Centers for Disease Control and Prevention (Africa CDC) – noting that he had in fact helped birth the agency with a proposal for its creation at an African Union summit in July 2013 when he was Ethiopia’s foreign minister. “So, Africa CDC is my daughter, and not only me, but WHO and our regional office, all of us, will do everything to strengthen it. The strengthen of continental institutions is very important to the advancement of health and other sectors in our continent,” he said. “In the same way,” he added, “we are also continuing to provide technical and financial support to the African Medicines Agency (AMA), to support greater regulatory capacity on the continent,” he added, of the new medicines agency that is supposed to help facilitate the more rapid and harmonized approval of new drugs and vaccines across Africa. Cessouma Minata Samate, AU’s Commissioner for Health, Humanitarian Affairs, and Social Development, at the opening ceremony of the 72nd session of the Regional Committee for Africa Last month, Health Policy Watch reported that the Executive Council of the African Union (AU) selected Rwanda to host the headquarters of the African Medicines Agency. Cessouma Minata Samate, AU’s Commissioner for Health, Humanitarian Affairs, and Social Development, said the AMA also aims to support the production of medicines on the African continent. “Through this agency, we are going to build the regulatory capacity of member states of the African Union and the regional economic community,” she said. While congratulating the government of Rwanda for being selected to host AMA’s headquarters, she urged the country to ensure the agency becomes operational as soon as possible. See our special coverage of the development of the AMA here: African Medicines Agency Countdown From prevention to battling inequity Dr Matshidiso Moeti, WHO’s Regional Director for Africa, noted the COVID-19 pandemic showed just how important it is for African countries to invest in health care and fighting diseases. In Africa last year, 22 million jobs were lost and 30 million more people were added to the ranks of extreme poverty, which is defined by the World Bank as living on less than US$1.90 a day. With things expected to continue this way into next year, she said, “these statistics make the case for investment in health very clear.” Inequity is a key factor impeding Africa’s health progress, according to Moeti, whether it is the lack of tools needed for prevention and responses to pandemics or the high out-of-pocket payments that prevent people from seeking health care when they need it. Moeti expressed continued WHO concern about the continent’s comparatively lower COVID-19 vaccination rate despite the recent availability of large quantities of doses. She said it puts health and jobs at unnecessary risk while opening the door to the emergence of new, potentially dangerous variants of the virus. “A fresh impetus to accelerate COVID-19 vaccine uptake is imperative, especially to safeguard our most vulnerable,” she said. Togo’s President Faure Gnassingbé at the opening ceremony of the 72nd session of the Regional Committee for Africa Togo eradicates four NTDs while fighting disease A highlight of the opening ceremony was the recognition of Togo’s efforts at disease prevention including the eradication of four neglected tropical diseases (NTDs). “The liberation of Togo from Dracunculiasis (Guinea-worm disease), Human African Trypanosomiasis, lymphatic filariasis and trachoma is a stunning achievement that will free many people from the threat of these devastating diseases,” Tedros said. “I also congratulate you,” he added,” “for the progress you have made in improving the management and efficiency of hospitals, and for increasing access to services for the population.” Togo’s President Faure Gnassingbé said health is at the center of his government’s development — and is a priority for social cohesion. He described Togo’s relationship with WHO as one that has transcended beyond institutional cooperation and is now a genuine partnership that supports Togo’s health systems, helping to coordinate emergency responses and to raise vaccine equity. “It is a partnership that guides us — learning from current crises with a view to sustainable, equitable and sound solutions,” he said. Image Credits: WHO. Monkeypox Vaccine: 62% of Recipients Experience No Side Effects, Says New Survey 22/08/2022 Maayan Hoffman Jynneos Monkeypox Vaccine A first-of-its-kind survey examining the side effects of the monkeypox vaccine in Israel found that the majority of recipients had no general symptoms. “Most of the side effects reported by the vaccinated are local and mild, which in most cases pass within one to three days,” said Miri Mizrahi Reuveni, Deputy CEO and Head of the Health Division at Maccabi Healthcare Services, which conducted the survey. Maccabi is one of Israel’s four major public health funds. This is some of the first data to be systematically reported on side effects of the vaccine and uptake since the outbreak began, however, the data does not reflect on the vaccine’s efficacy which will take more time to assess. Specifically, some 62% of 155 vaccine recipients reported a return to routine without any general symptoms, Maccabi reported on Monday. The other 38% experienced side effects. Among those who experienced side effects, most fell into broad categories: 27% reported weakness and fatigue; 11% complained of muscle pain; 9% had headaches; 6% suffered from diarrhea; 5% got nausea; 4% had less appetite and swelling of the lymph nodes; 3% felt chills and joint pain; 1% got a skin rash; and another 1% felt eye irritation. A majority of recipients, or 74%, experienced pain at the site of injection, including stiffness (22%), localized swelling (7%) and itching (6%). In most cases, those who experienced side effects said they lasted more than 24 hours. But 22% of recipients who had symptoms said they persist today. Only 3 percent reported that their symptoms passed in less than 24 hours. About 10% said they lasted one day; 39% said they ended within two to three days; and 19% complained of symptoms that took four to six days to resolve. Eight-five percent of respondents said they had no hesitation about getting the jab. The health fund also asked people why they decided to get vaccinated. The most common responses were a desire to protect themselves and those around them. More than a third said they also were afraid of becoming isolated. More than people who belong to the HMO have taken the vaccine already, according to Reuveni. The survey began when the country started distributing the vaccine at the start of August. Respondents were asked questions after they got the shot and seven days later. As of the end of last week, the Israeli Health Ministry reported 197 cases of monkeypox in the country, all of them involving men. Ministry officials told Health Policy Watch on Monday that so far more than 2,300 Israelis have been vaccinated against the virus. The country recently expanded its vaccination criteria to allow more people to get the shot. Israel ordered 10,000 vaccine doses, of which a little more than half have arrived. Some 4,400 vaccine doses are expected to arrive at the beginning of September, ministry officials said. The international monkeypox outbreak began on May 4 when a first case outside of historically endemic African countries was discovered in London. Since then, it has spread across the world, according to the World Health Organization (WHO), with more than 35,000 cases of monkeypox reported from 92 countries and territories accompanied by 12 deaths. WHO Monkeypox Dashboard as of 22 August 2022 Image Credits: Star919News/Twitter , WHO. Open Access 240 Compound Collection Launched in Fight Against Infectious and Mosquito-Borne Illnesses for World Mosquito Day 22/08/2022 Raisa Santos Aedes aegypti mosquito can spread Zika fever, dengue, and other diseases. To mark World Mosquito Day, 20 August, the Global Health Priority Box has been launched to provide free access to 240 compounds to stimulate research into new drugs and insecticides. The initiative, launched by the Medicines for Malaria Venture (MMV) and the Innovative Vector Control Consortium (IVCC), provides scientists with starting points to advance the development of tools that can tackle several priorities set out by the WHO in late 2021, including drug resistance and communicable diseases. Every year vector-borne diseases such as malaria cause the loss of more than 700,000 lives annually, predominantly in regions with tropical climates in low- and middle-income countries. Major vector-borne diseases account for 17% of the global burden of communicable diseases. Recent studies have shown that climate change has the potential to shift the regions in which disease-carrying mosquitoes breed, introducing new pathogens to previously unaffected areas. For example, the spread of malaria, caused by a parasite that spreads to humans and other animals through the bites of infected female mosquitoes, increases in temperatures of around 25ºC. Coupled with the increasing prevalence of drug-resistant superbugs and insecticide resistance, it is clear that new tools are needed to fight against vector-borne diseases. “Efforts to end infectious diseases will only succeed if we have the tools to treat and prevent them,” said Dr Timothy Wells, MMV’s Chief Scientific Officer. Collection of compounds for malaria, neglected and zoonotic diseases, and more The collection features 240 compounds that can be used against drug-resistant malaria, neglected and zoonotic diseases, and other diseases at risk of drug resistance. This includes: 80 compounds with confirmed activity against drug-resistant malaria. 80 compounds for screening against neglected and zoonotic diseases, and diseases at risk of drug resistance. 80 compounds that have been tested for activity against various vector species. Priority Box’s ‘open approach’ emphasizes international collaboration The Global Health Priority Box’s builds on the reaction of the scientific community to the COVID-19 pandemic, which demonstrated that international collaboration accelerates the development of new tools, diagnostics and vaccines. Its open approach invites scientists to make screening results publicly available and to publish findings in an open access journal within two years following data generation. Such an approach allows for researchers around the world to build on one another’s work, saving time and resources. “Open innovation is one of the keys to unlocking drug discovery because it allows us to tap into existing knowledge and expertise and build on it collaboratively,” said Wells. Dr Nick Hamon, CEO of IVCC, noted the need for innovation in vector control due to the increased prevalence of insecticide resistance, “which is undermining the efficacy of bed nets and indoor residual sprays, the cornerstone of malaria prevention since the turn of the century.” “Open access to new chemistry will encourage greater collaboration across the scientific community, bringing new innovators into public health and potentially more rapid development of new vector control solutions,” he said. Image Credits: Sanofi Pasteur/Flickr. WHO Recommends Two Monoclonal Antibodies for Ebola Treatment; Calls to Expand Access in Developing Countries 19/08/2022 John Heilprin A health worker dresses in protective clothing to enter the treatment unit for a suspected Ebola case at western Uganda’s Bwera General Hospital in August 2019 – during the 2018-2020 Ebola outbreak in the neighboring Democratic Republic of Congo. In its first guidelines ever for Ebola treatment, the World Health Organization (WHO) advises using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease, including older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth,” WHO says. In its launch of the recommendations, WHO also called on the global community “to increase access to these lifesaving medicines”. As relatively new therapies, monoclonal antibodies have been difficult and expensive to access in low- and middle-income countries, with 80% of their sales occuring in the US, Canada and Europe. In 2020, a consortium of research organizations, led by Wellcome Trust issued a global call to action to expand access. Yes to Ansuvimab and Inmazeb, No to ZMapp and Remdesivir Patients should receive recommended neutralizing monoclonal antibodies as soon as possible after laboratory confirmation of diagnosis, according to WHO. Its new 44-page guidelines for Ebola treatment also makes a “conditional recommendation against” the use of ZMapp and remdesivir for patients with the Ebola virus. ZMapp, a drug cocktail of antibodies developed from the tobacco plant, was the first drug to be used on an experimental basis against the Ebola virus. Initially it showed promise with rhesus monkeys, but was not fully tested on humans. During the 2014-2016 Ebola epidemic in West Africa, however, the US Food and Drug Administration (FDA) approved ZMapp’s experimental use on patients. That epidemic, the continent’s largest ever, killed more than 11,000 people out of the 28,000 people who became ill with the virus. Subsequently, ZMapp, remdesivir as well as mAb114 and REGN-EB3 were all tested against one another in a randomized controlled trial in the Democratic Republic of Congo, running in parallel to the Ebola epidemic that wracked the eastern region of the country between 2018-2020. In August 2019, however, an independent monitoring board recommended early termination of the DRC therapeutics trial due to the favorable results demonstrated by the latter two drug candidates. The board recommended that all patients be randomized to receive either REGN-EB3 or mAb114 in an extension phase. The study’s preliminary results among 499 participants showed people who got REGN-EB3 or mAb114 had a greater chance of survival than those who received ZMapp or remdesivir. Remdesivir was originally developed to treat hepatitis C before it was investigated for treating the Ebola and Marburg viruses, and then as a post-infection treatment for COVID‑19. It eventually won US and European Medicines Agency approval as a COVID-19 treatment. However, in November 2020, WHO recommended against Remdesivir use for COVID, saying there was “no evidence” it improved patient outcomes. Access remains a problem for ebola treatment In its recommendations, WHO called for greater efforts to ensure that that the drugs are “where patients need them the most: where there is an active Ebola outbreak, or where the threat of outbreaks is high or very likely.” To assist with that goal, WHO offered to support “countries, manufacturers and partners” to step up national and global efforts to increase affordability of the biotherapeutic products. “Access to these therapeutics is challenging and pricing and future supply remain unknown, especially in resource-poor areas,” WHO says in its 44-page guidelines. “Without concerted effort, access will remain limited, and it is therefore possible that this strong recommendation could exacerbate health inequity,” it says. “Therefore, given the demonstrated benefits for patients, these recommendations should act as a stimulus to engage all possible mechanisms to improve global access to these treatments.” Both Inmazeb and Ebanga were developed with significant US government support The development of both Inmazeb and Ebanga was heavily supported by the US government and other public funders. Inmazeb, which also was the first FDA-approved treatment for Ebola, is produced by the US-based Regeneron Pharmaceuticals. It was developed in response to the 2018 Ebola outbreak in the DRC with supprot from the US Biomedical Advanced Research and Development Authority (BARDA). Regeneron announced in 2020, the company will “continue to provide Inmazeb for free in response to outbreaks in the DRC through the MEURI protocol for compassionate use,” in colaboration with the WHO, the US FDA and with continuing support from BARDA. “Regeneron is actively working with nongovernmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries,” the company declared at that time. The MEURI protocol is a WHO-approved ethical framework for the use of investigational agents. Regeneron gained fame in the first year of the COVID pandemic when former President Donald Trump was treated with another antibody cocktail that it had developed against COVID, (REGEN-COV- a combination of casirivimab and imdevimab) . The cocktail was later recommended by WHO for COVID treatment. As for Ebanga, it was initially developed by the Vaccine Research Center of the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), and then licensed in 2018 by the US biotech firm, Ridgeback Biotherapeutics for further development and ultimately FDA aprpoval. “Ebanga is currently available to patients, and Ridgeback Biotherapeutics provides and distributes the treatment to patients free of charge in Ebola-stricken countries,” the company states on its website. WHO publishes invitation to drug manufacturers to share drugs for evaluation WHO says it has now published the first invitation to manufacturers of therapeutics against Ebola virus disease to share their drugs for evaluation by the WHO Prequalification Unit, a crucial step to enabling bulk procurement of new drugs by global health agencies, for communities and countries affected by Ebola. “We have seen incredible advances in both the quality and safety of clinical care during Ebola outbreaks,” said Dr Janet Diaz, lead of the clinical management unit in WHO’s Health Emergencies program. “Doing the basics well, including early diagnosis, providing optimized supportive care with the evaluation of new therapeutics under clinical trials, has transformed what is possible during Ebola outbreaks,” she said. “This is what has led to development of a new standard of care for patients. However, timely access to these lifesaving interventions has to be a priority.” WHO also says there is a need for more research and evaluation of clinical interventions because of the large number of “uncertainties” that remain including with supportive care, with our understanding and characterization of the Ebola virus disease and its longer-term consequences, with the continued inclusion of vulnerable populations such as pregnant women, newborns, children and older people in future research. Back to the DRC for More Research, Studies on Ebola treatment The clinical trials used to shape WHO’S guidelines for Ebola treatment were conducted during the Ebola outbreaks that have raged in central and west Africa over the past six years; the largest trial was conducted in the Democratic Republic of the Congo (DRC) which saw a major outbreak in 2018-2020, as well as small outbreaks since then. Ebola is a severe and too often fatal illness, and previous outbreaks and responses showed the importance of early diagnosis and treatment with optimized supportive care that includes fluid and electrolyte repletion and treatment of symptoms. “This therapeutic guide is a critical tool to fight Ebola,” said Dr Richard Kojan, co-chair of the Guideline Development Group of experts selected by WHO and President of ALIMA, The Alliance for International Medical Action. “It will help reassure the communities, health care workers and patients, that this life-threatening disease can be treated thanks to effective drugs,” said Kojan. “From now on, people infected with the Ebola virus will have a greater chance of recovering if they seek care as early as possible,” he said. “As with other infectious diseases, timeliness is key, and people should not hesitate to consult health workers as quickly as possible to ensure they receive the best care possible.” The DRC has now recorded 14 Ebola outbreaks since 1976, including six since 2018. The most recent outbreak, which began in April, was declared to be over by DRC and WHO authorities last month — with fewer cases and deaths (five) than previous episodes due to a swift response including vaccinations. Vaccinations were launched less than a week after the outbreak was declared, using an ultra-cold chain freezer in Mbandaka so vaccine doses could be stored locally and safely, and delivered effectively. That enabled 2,104 people to be vaccinated, including 1,307 frontline workers and 302 contacts. In the previous outbreak in Equateur Province from June to November 2020, 130 people were infected and 55 died. Africa’s battles with Ebola and other deadly diseases also helped prepare its health systems to deal with COVID-19. When SARS-CoV2 virus landed on the continent, the African Centres for Disease Control (CDC) reinforced its regional coordinating centers, enhanced lab capacity and unified surveillance networks. An Additional Tool for Ebola treatment Along With Clinical Care Guidance The new Ebola treatment guidelines are meant to complement clinical care guidance that outlines the optimized supportive care Ebola patients should receive including factors such as relevant tests, pain management, nutrition and co-infections. But the recommendations only apply to the Ebola virus disease caused by Ebola virus (EBOV; Zaire ebolavirus). “Advances in supportive care and therapeutics over the past decade have revolutionized the treatment of Ebola. Ebola virus disease used to be perceived as a near certain killer. However, that is no longer the case,” said Dr Robert Fowler of the University of Toronto and co-chair of the Guideline Development Group of experts selected by WHO. “Provision of best supportive medical care to patients, combined with monoclonal antibody treatment — MAb114 or REGN-EB3 — now leads to recovery for the vast majority of people,” he said. 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Health System “Shaken” by Ukraine War 24/08/2022 John Heilprin COVID-19 patient in severe state in Chernivtsi, southwestern Ukraine. As the SARS-CoV2 pandemic wanes, health services must deal with a health emergency – created solely by human forces. Six months into the Ukraine war, the World Health Organization warns that the nation’s battered but “still-resilient” health system is facing “severe challenges and shortages in many areas” that must be dealt with as the nation prepares for a challenging winter. WHO officials marked the half-year point in the war, which coincided with Ukraine’s Independence Day, with a somber reflection on the state of the nation’s life-saving health system. The UN healthy agency says Ukraine has a “badly affected but still-resilient health system” even as attacks on it continue. Since the war began with Russia’s invasion on February 24, WHO says it has verified 473 attacks carried out on health systems, including facilities and personnel, resulting in at least 98 deaths and 134 injuries. In May, the World Health Assembly approved a resolution condemning the Ukraine war by 88 votes to 12. But the 53 abstentions reflected the discomfort of many member states with a debate that polarised the global health body. Most African nations abstained, as did many Middle Eastern nations, India and Pakistan. Most of Europe, the United States, Oceania and many Latin American countries supported the Ukrainian-backed resolution, which condemns “in the strongest terms, Russian Federation’s military aggression against Ukraine, including attacks on health care facilities.” Empty hospital beds line the hallways of the Kyiv Regional Perinatal Centre, Ukraine, on 7 March 2022. As hospitals are disrupted or destroyed, online healthcare services can mitigate gaps. Health System “Shaken” by Ukraine War, But Not “Collapsed” WHO says it is supporting Ukraine’s Ministry of Health in the Ukraine war by helping to restore disrupted services, displaced health workers and destroyed infrastructure. It also helped the ministry and partners deliver more than 1300 metric tonnes of medical supplies, WHO says, including power generators, ambulances and oxygen supplies for medical facilities. The UN health agency says those deliveries also include supplies for trauma and emergency surgeries and medicines to help treat noncommunicable diseases (NCDs). “Six months of war have had a devastating impact on the health and lives of Ukraine’s people, but despite many challenges the health system has managed to survive and deliver care where and when it is needed most,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Though shaken, the health system has not collapsed,” he said. “But no system can deliver optimum health to its people under the stress of war, which is why we continue to call on the Russian Federation to end this war.” After six months of war, #Ukraine’s badly affected but still-resilient health system is taking stock of lessons learnt in providing lifesaving care as it prepares for a challenging winter ahead.@WHO and partners are ready to provide continued support.https://t.co/Ezsrc5qgGe pic.twitter.com/caTNNgXkUk — WHO Ukraine (@WHOUkraine) August 24, 2022 Ukraine War’s “Horror” Demands Mental Health Response Dr Hans Henri Kluge, WHO Regional Director for Europe, said attacks on health care violate international humanitarian law and are “unconscionable” because they kill and maim civilians and health-care providers, and severely hinder or prevent the delivery of health care services to those who needed it most. “Amid the horror of war,” he said, “we continue to witness the heroic efforts of health providers – including the many I’ve been privileged to meet in person myself – who are such a credit to their profession despite their own personal suffering.” WHO also has helped train more than 9000 health care workers. Areas of focus include trauma surgery, mass casualties, chemical exposure, epidemiology and laboratory diagnostics. But mental health, including stress management for health care workers and the public, is a priority in the Ukraine war. “WHO is stepping up its efforts with the Ministry of Health to ensure that the health workforce is prepared with the necessary skills to respond to mounting needs as winter approaches,” said Dr Jarno Habicht, WHO Representative in Ukraine. “We’re already seeing severe challenges and shortages in many areas, with rising inequalities in access to health and other essentials, impacting, as always, the most vulnerable – women, children and the elderly,” said Habicht. “Even as we look to a time when peace is restored,” he said, “we must focus on the here and now – the next six months could test Ukraine’s health system as never before.” A destroyed tank is abandoned on the road to Bucha, Ukraine. Image Credits: Mstyslav Chernov/ Wikimedia Commons, UNICEF/Oleksandr Ratushniak, Marco Frattini/ World Food Program. Pfizer Submits Reguest to US FDA for Approval of Omicron-targeted COVID Booster Shot 23/08/2022 Zachary Brennan, via Endpoints News Albert Bourla, CEO of Pfizer, at a World Economic Forum meeting in 2018. The Omicron-targeted boosters are coming. Almost 250 days since Omicron became the dominant variant in the US, Pfizer and BioNTech on Monday officially announced that they’ve requested an Emergency Use Authorization (EUA) from the US Food and Drug Administration for their booster dose of an Omicron BA.4/BA.5-adapted bivalent vaccine for those 12 and older. The application’s submission comes as BioNTech said earlier this month that it expects to begin delivering Omicron-adapted vaccines as early as October, subject to regulatory approval. The FDA’s vaccine advisory committee in late June gave the thumbs up — by a vote of 19-2 — to requiring an Omicron-related component in this season’s booster dose; both Pfizer/BioNTech and Moderna have been working on such boosters over the past few months. The EUA for Pfizer/BioNTech’s booster would be based on preclinical data showing that it generated a strong neutralizing antibody response against the BA.4/BA.5 variants, as well as safety, tolerability and immunogenicity data from a Phase II/III trial of a 30-µg booster dose of the companies’ other, Omicron BA.1-adapted bivalent vaccine candidate. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month, Pfizer and BioNTech said. FDA to Pfizer: Test another course of Paxlovid for those rebounding In other COVID-related drug developments, the FDA earlier this month quietly called on Pfizer to test another course of its Covid-19 antiviral Paxlovid for those who have rebounded and tested positive after an initial dose. On Aug. 5, the FDA reissued its EUA letter for Paxlovid to include additional post-authorization requirements, including calling on Pfizer “to conduct a clinical trial in patients with ‘COVID-19 rebound’ and a clinical trial evaluating different durations of treatment in immunocompromised patients with mild-to-moderate Covid-19.” Pfizer told Bloomberg News that it is “working with the FDA to finalize a protocol to study patients who may be in need of retreatment,” and the trial protocol is expected to be finalized this month. FDA expands Novavax EUA for teenagers Additionally, US teenagers looking for an option outside of the mRNA Covid-19 vaccines will now be able to turn to Novavax’s Covid-19 vaccine which won an expanded EUA on Friday from the FDA. Those aged 12 through 17 will gain access to the Novavax vaccine after the company submitted data from an ongoing pediatric expansion of its Phase III trial of 2,247 adolescents within that same age range across 75 sites in the US. The company said that in this population the vaccine achieved its primary efficacy endpoint, with clinical efficacy of about 78% (95% CI: 37.55%, 92.45%) overall, at a time when the Delta variant was the predominant circulating variant. The efficacy analysis was supported by assessment of antibody titers that were shown to be higher in adolescents than in young adults, Novavax added. Canada buys 12M doses of Moderna’s Omicron-targeted booster Meanwhile, mRNA powerhouse Moderna said Monday that Canada’s government has exercised its option to purchase an additional 4.5 million doses of an Omicron-containing bivalent vaccine booster candidate, in addition to moving forward the scheduled delivery of 1.5 million doses of the bivalent vaccine candidate from 2023 to 2022. Moderna and Canada also agreed to shift six million doses of the current vaccine to the Omicron-containing vaccine, subject to regulatory approval, with doses scheduled for delivery this year. The vaccine is expected to be ready for deployment in the US in October. ______________________________________________________ This article was first published by Endpoints News. Image Credits: Flickr – World Economic Forum. WHO Warns of New Ebola Threat in DRC 23/08/2022 John Heilprin A health worker in Democratic Republic of the Congo’s eastern province of North Kivu. A new case of Ebola has been confirmed in the Democratic Republic of the Congo’s eastern province of North Kivu, prompting health authorities to declare a resurgence of the deadly virus, World Health Organization (WHO) officials said on Tuesday. WHO announced that health authorities confirmed a 46-year-old woman died of the disease on 15 August in Beni, a town located in North Kivu. She initially received care for other ailments at the Beni Referral Hospital, who said, but the began exhibiting symptoms consistent with Ebola. A statement from WHO said both the Beni and Goma branches of the DRC’s National Institute of Biomedical Research (INRB) confirmed Ebola virus in samples taken from the patient. Further analysis showed her death was genetically linked to the 2018-2020 outbreak in North Kivu and Ituri provinces that was the country’s longest and largest. Last week, WHO issued its first guidelines ever for Ebola treatment. It advised using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease,” WHO says. That includes older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth. Dr Matshidiso Moeti, WHO Africa Executive Director. Battling ‘Greater Frequency’ of Resurgent Ebola Cases This latest resurgence comes just four months after the Ebola outbreak that erupted on 23 April in DRC was declared to be over by DRC and WHO authorities, with fewer cases and deaths than previous episodes due to a swift response including vaccinations. The last time the disease flared up in Beni it was brought under control in about two months and ended in mid-December 2021, after causing six deaths among eight confirmed and three probable cases. “Ebola resurgences are occurring with greater frequency in the Democratic Republic of the Congo which is concerning,” said Dr Matshidiso Moeti, World Health Organization (WHO) Regional Director for Africa. “However, health authorities in North Kivu have successfully stopped several Ebola flareups and, building on this expertise, will no doubt bring this one under control quickly,” Moeti said. Some 160 people have been identified as contacts and their health is being closely monitored by WHO staff and DRC health authorities, WHO said, and it has not yet been determined whether the woman who died was vaccinated. The nation has 1,000 doses of the rVSV-ZEBOV Ebola vaccine in its stockpile, including 200 that are being shipped to Beni this week. Ebola, which is spread by contact with the bodily fluids of an infected person or contaminated materials, produces early symptoms of fever and muscle aches like malaria. WHO’s “ring vaccination” strategy — vaccinating people who came into contact with patients — is expected to begin shortly after having shown some effectiveness at preventing new cases and limiting the spread of the disease in the DRC. WHO has been supporting DRC’s government to scale up testing, contact tracing and public health measures. Stockpiles of Ebola vaccines from the cities of Goma and Kinshasa were transported to Mbandaka earlier this year so vaccinations could start. A targeted Ebola vaccination campaign aimed at tracing and immunizing contacts was underway in Mbandaka, a city in DR Congo’s north-western Equateur Province. Image Credits: WHO. WHO Advocates Prevention Focus in Africa 23/08/2022 Paul Adepoju & John Heilprin WHO Director-General Dr Tedros Adhanom Ghebreyesus at the opening of the 72nd session of the Regional Committee for Africa African nations need to pivot to prevention in their fight against disease by “addressing its root causes” through a greater focus on improved diets, healthier environments, and better road safety, among other factors, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the 72nd WHO Regional Committee for Africa meeting, at the opening of the weeklong session of member states in Togo’s capital Lomé. Tedros also pledged WHO’s continued support for the work of the African Centers of Disease Control (Africa CDC) in remarks aimed at squelching tensions between the two agencies that emerged earlier this summer. Africa CDC began circulating a proposal for it to be empowered by the African Union to declare continental health emergencies, something WHO reportedly opposed. The Fuss Over Who Should Declare Public Health Emergencies in Africa This week’s meeting of African health ministers and government officials is supposed to focus on ways to lower the burden of disease, strengthen capacity and endorse strategies in fighting disease and promoting access to health services and people’s well-being. It also is looking at how the continent can improve prevention and battle COVID-19 and a growing number of other health challenges from outbreaks of communicable diseases, conflicts and humanitarian crises, climatic change and chronic diseases. “Realizing our vision for the highest attainable standard of health starts not in the clinic or the hospital, but in schools, streets, supermarkets, households and cities,” Tedros told the meeting. It was his first major appearance since he formally began his second five-term at the helm of the 194-nation UN health agency a week ago. “Much of the work that you do as ministries of health is dealing with the consequences of poor diets, polluted environments, unsafe roads and workplaces, inadequate health literacy, and the aggressive marketing of products that harm health,” he said. “That’s why,” Tedros said, “we are calling on all member states to make an urgent paradigm shift, towards promoting health and well-being and preventing disease by addressing its root causes, and creating the conditions for health to thrive.” Pledging support for Africa CDC and the African Medicines Agency Tedros also pledged WHO’s continued financial and technical support Africa Centers for Disease Control and Prevention (Africa CDC) – noting that he had in fact helped birth the agency with a proposal for its creation at an African Union summit in July 2013 when he was Ethiopia’s foreign minister. “So, Africa CDC is my daughter, and not only me, but WHO and our regional office, all of us, will do everything to strengthen it. The strengthen of continental institutions is very important to the advancement of health and other sectors in our continent,” he said. “In the same way,” he added, “we are also continuing to provide technical and financial support to the African Medicines Agency (AMA), to support greater regulatory capacity on the continent,” he added, of the new medicines agency that is supposed to help facilitate the more rapid and harmonized approval of new drugs and vaccines across Africa. Cessouma Minata Samate, AU’s Commissioner for Health, Humanitarian Affairs, and Social Development, at the opening ceremony of the 72nd session of the Regional Committee for Africa Last month, Health Policy Watch reported that the Executive Council of the African Union (AU) selected Rwanda to host the headquarters of the African Medicines Agency. Cessouma Minata Samate, AU’s Commissioner for Health, Humanitarian Affairs, and Social Development, said the AMA also aims to support the production of medicines on the African continent. “Through this agency, we are going to build the regulatory capacity of member states of the African Union and the regional economic community,” she said. While congratulating the government of Rwanda for being selected to host AMA’s headquarters, she urged the country to ensure the agency becomes operational as soon as possible. See our special coverage of the development of the AMA here: African Medicines Agency Countdown From prevention to battling inequity Dr Matshidiso Moeti, WHO’s Regional Director for Africa, noted the COVID-19 pandemic showed just how important it is for African countries to invest in health care and fighting diseases. In Africa last year, 22 million jobs were lost and 30 million more people were added to the ranks of extreme poverty, which is defined by the World Bank as living on less than US$1.90 a day. With things expected to continue this way into next year, she said, “these statistics make the case for investment in health very clear.” Inequity is a key factor impeding Africa’s health progress, according to Moeti, whether it is the lack of tools needed for prevention and responses to pandemics or the high out-of-pocket payments that prevent people from seeking health care when they need it. Moeti expressed continued WHO concern about the continent’s comparatively lower COVID-19 vaccination rate despite the recent availability of large quantities of doses. She said it puts health and jobs at unnecessary risk while opening the door to the emergence of new, potentially dangerous variants of the virus. “A fresh impetus to accelerate COVID-19 vaccine uptake is imperative, especially to safeguard our most vulnerable,” she said. Togo’s President Faure Gnassingbé at the opening ceremony of the 72nd session of the Regional Committee for Africa Togo eradicates four NTDs while fighting disease A highlight of the opening ceremony was the recognition of Togo’s efforts at disease prevention including the eradication of four neglected tropical diseases (NTDs). “The liberation of Togo from Dracunculiasis (Guinea-worm disease), Human African Trypanosomiasis, lymphatic filariasis and trachoma is a stunning achievement that will free many people from the threat of these devastating diseases,” Tedros said. “I also congratulate you,” he added,” “for the progress you have made in improving the management and efficiency of hospitals, and for increasing access to services for the population.” Togo’s President Faure Gnassingbé said health is at the center of his government’s development — and is a priority for social cohesion. He described Togo’s relationship with WHO as one that has transcended beyond institutional cooperation and is now a genuine partnership that supports Togo’s health systems, helping to coordinate emergency responses and to raise vaccine equity. “It is a partnership that guides us — learning from current crises with a view to sustainable, equitable and sound solutions,” he said. Image Credits: WHO. Monkeypox Vaccine: 62% of Recipients Experience No Side Effects, Says New Survey 22/08/2022 Maayan Hoffman Jynneos Monkeypox Vaccine A first-of-its-kind survey examining the side effects of the monkeypox vaccine in Israel found that the majority of recipients had no general symptoms. “Most of the side effects reported by the vaccinated are local and mild, which in most cases pass within one to three days,” said Miri Mizrahi Reuveni, Deputy CEO and Head of the Health Division at Maccabi Healthcare Services, which conducted the survey. Maccabi is one of Israel’s four major public health funds. This is some of the first data to be systematically reported on side effects of the vaccine and uptake since the outbreak began, however, the data does not reflect on the vaccine’s efficacy which will take more time to assess. Specifically, some 62% of 155 vaccine recipients reported a return to routine without any general symptoms, Maccabi reported on Monday. The other 38% experienced side effects. Among those who experienced side effects, most fell into broad categories: 27% reported weakness and fatigue; 11% complained of muscle pain; 9% had headaches; 6% suffered from diarrhea; 5% got nausea; 4% had less appetite and swelling of the lymph nodes; 3% felt chills and joint pain; 1% got a skin rash; and another 1% felt eye irritation. A majority of recipients, or 74%, experienced pain at the site of injection, including stiffness (22%), localized swelling (7%) and itching (6%). In most cases, those who experienced side effects said they lasted more than 24 hours. But 22% of recipients who had symptoms said they persist today. Only 3 percent reported that their symptoms passed in less than 24 hours. About 10% said they lasted one day; 39% said they ended within two to three days; and 19% complained of symptoms that took four to six days to resolve. Eight-five percent of respondents said they had no hesitation about getting the jab. The health fund also asked people why they decided to get vaccinated. The most common responses were a desire to protect themselves and those around them. More than a third said they also were afraid of becoming isolated. More than people who belong to the HMO have taken the vaccine already, according to Reuveni. The survey began when the country started distributing the vaccine at the start of August. Respondents were asked questions after they got the shot and seven days later. As of the end of last week, the Israeli Health Ministry reported 197 cases of monkeypox in the country, all of them involving men. Ministry officials told Health Policy Watch on Monday that so far more than 2,300 Israelis have been vaccinated against the virus. The country recently expanded its vaccination criteria to allow more people to get the shot. Israel ordered 10,000 vaccine doses, of which a little more than half have arrived. Some 4,400 vaccine doses are expected to arrive at the beginning of September, ministry officials said. The international monkeypox outbreak began on May 4 when a first case outside of historically endemic African countries was discovered in London. Since then, it has spread across the world, according to the World Health Organization (WHO), with more than 35,000 cases of monkeypox reported from 92 countries and territories accompanied by 12 deaths. WHO Monkeypox Dashboard as of 22 August 2022 Image Credits: Star919News/Twitter , WHO. Open Access 240 Compound Collection Launched in Fight Against Infectious and Mosquito-Borne Illnesses for World Mosquito Day 22/08/2022 Raisa Santos Aedes aegypti mosquito can spread Zika fever, dengue, and other diseases. To mark World Mosquito Day, 20 August, the Global Health Priority Box has been launched to provide free access to 240 compounds to stimulate research into new drugs and insecticides. The initiative, launched by the Medicines for Malaria Venture (MMV) and the Innovative Vector Control Consortium (IVCC), provides scientists with starting points to advance the development of tools that can tackle several priorities set out by the WHO in late 2021, including drug resistance and communicable diseases. Every year vector-borne diseases such as malaria cause the loss of more than 700,000 lives annually, predominantly in regions with tropical climates in low- and middle-income countries. Major vector-borne diseases account for 17% of the global burden of communicable diseases. Recent studies have shown that climate change has the potential to shift the regions in which disease-carrying mosquitoes breed, introducing new pathogens to previously unaffected areas. For example, the spread of malaria, caused by a parasite that spreads to humans and other animals through the bites of infected female mosquitoes, increases in temperatures of around 25ºC. Coupled with the increasing prevalence of drug-resistant superbugs and insecticide resistance, it is clear that new tools are needed to fight against vector-borne diseases. “Efforts to end infectious diseases will only succeed if we have the tools to treat and prevent them,” said Dr Timothy Wells, MMV’s Chief Scientific Officer. Collection of compounds for malaria, neglected and zoonotic diseases, and more The collection features 240 compounds that can be used against drug-resistant malaria, neglected and zoonotic diseases, and other diseases at risk of drug resistance. This includes: 80 compounds with confirmed activity against drug-resistant malaria. 80 compounds for screening against neglected and zoonotic diseases, and diseases at risk of drug resistance. 80 compounds that have been tested for activity against various vector species. Priority Box’s ‘open approach’ emphasizes international collaboration The Global Health Priority Box’s builds on the reaction of the scientific community to the COVID-19 pandemic, which demonstrated that international collaboration accelerates the development of new tools, diagnostics and vaccines. Its open approach invites scientists to make screening results publicly available and to publish findings in an open access journal within two years following data generation. Such an approach allows for researchers around the world to build on one another’s work, saving time and resources. “Open innovation is one of the keys to unlocking drug discovery because it allows us to tap into existing knowledge and expertise and build on it collaboratively,” said Wells. Dr Nick Hamon, CEO of IVCC, noted the need for innovation in vector control due to the increased prevalence of insecticide resistance, “which is undermining the efficacy of bed nets and indoor residual sprays, the cornerstone of malaria prevention since the turn of the century.” “Open access to new chemistry will encourage greater collaboration across the scientific community, bringing new innovators into public health and potentially more rapid development of new vector control solutions,” he said. Image Credits: Sanofi Pasteur/Flickr. WHO Recommends Two Monoclonal Antibodies for Ebola Treatment; Calls to Expand Access in Developing Countries 19/08/2022 John Heilprin A health worker dresses in protective clothing to enter the treatment unit for a suspected Ebola case at western Uganda’s Bwera General Hospital in August 2019 – during the 2018-2020 Ebola outbreak in the neighboring Democratic Republic of Congo. In its first guidelines ever for Ebola treatment, the World Health Organization (WHO) advises using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease, including older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth,” WHO says. In its launch of the recommendations, WHO also called on the global community “to increase access to these lifesaving medicines”. As relatively new therapies, monoclonal antibodies have been difficult and expensive to access in low- and middle-income countries, with 80% of their sales occuring in the US, Canada and Europe. In 2020, a consortium of research organizations, led by Wellcome Trust issued a global call to action to expand access. Yes to Ansuvimab and Inmazeb, No to ZMapp and Remdesivir Patients should receive recommended neutralizing monoclonal antibodies as soon as possible after laboratory confirmation of diagnosis, according to WHO. Its new 44-page guidelines for Ebola treatment also makes a “conditional recommendation against” the use of ZMapp and remdesivir for patients with the Ebola virus. ZMapp, a drug cocktail of antibodies developed from the tobacco plant, was the first drug to be used on an experimental basis against the Ebola virus. Initially it showed promise with rhesus monkeys, but was not fully tested on humans. During the 2014-2016 Ebola epidemic in West Africa, however, the US Food and Drug Administration (FDA) approved ZMapp’s experimental use on patients. That epidemic, the continent’s largest ever, killed more than 11,000 people out of the 28,000 people who became ill with the virus. Subsequently, ZMapp, remdesivir as well as mAb114 and REGN-EB3 were all tested against one another in a randomized controlled trial in the Democratic Republic of Congo, running in parallel to the Ebola epidemic that wracked the eastern region of the country between 2018-2020. In August 2019, however, an independent monitoring board recommended early termination of the DRC therapeutics trial due to the favorable results demonstrated by the latter two drug candidates. The board recommended that all patients be randomized to receive either REGN-EB3 or mAb114 in an extension phase. The study’s preliminary results among 499 participants showed people who got REGN-EB3 or mAb114 had a greater chance of survival than those who received ZMapp or remdesivir. Remdesivir was originally developed to treat hepatitis C before it was investigated for treating the Ebola and Marburg viruses, and then as a post-infection treatment for COVID‑19. It eventually won US and European Medicines Agency approval as a COVID-19 treatment. However, in November 2020, WHO recommended against Remdesivir use for COVID, saying there was “no evidence” it improved patient outcomes. Access remains a problem for ebola treatment In its recommendations, WHO called for greater efforts to ensure that that the drugs are “where patients need them the most: where there is an active Ebola outbreak, or where the threat of outbreaks is high or very likely.” To assist with that goal, WHO offered to support “countries, manufacturers and partners” to step up national and global efforts to increase affordability of the biotherapeutic products. “Access to these therapeutics is challenging and pricing and future supply remain unknown, especially in resource-poor areas,” WHO says in its 44-page guidelines. “Without concerted effort, access will remain limited, and it is therefore possible that this strong recommendation could exacerbate health inequity,” it says. “Therefore, given the demonstrated benefits for patients, these recommendations should act as a stimulus to engage all possible mechanisms to improve global access to these treatments.” Both Inmazeb and Ebanga were developed with significant US government support The development of both Inmazeb and Ebanga was heavily supported by the US government and other public funders. Inmazeb, which also was the first FDA-approved treatment for Ebola, is produced by the US-based Regeneron Pharmaceuticals. It was developed in response to the 2018 Ebola outbreak in the DRC with supprot from the US Biomedical Advanced Research and Development Authority (BARDA). Regeneron announced in 2020, the company will “continue to provide Inmazeb for free in response to outbreaks in the DRC through the MEURI protocol for compassionate use,” in colaboration with the WHO, the US FDA and with continuing support from BARDA. “Regeneron is actively working with nongovernmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries,” the company declared at that time. The MEURI protocol is a WHO-approved ethical framework for the use of investigational agents. Regeneron gained fame in the first year of the COVID pandemic when former President Donald Trump was treated with another antibody cocktail that it had developed against COVID, (REGEN-COV- a combination of casirivimab and imdevimab) . The cocktail was later recommended by WHO for COVID treatment. As for Ebanga, it was initially developed by the Vaccine Research Center of the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), and then licensed in 2018 by the US biotech firm, Ridgeback Biotherapeutics for further development and ultimately FDA aprpoval. “Ebanga is currently available to patients, and Ridgeback Biotherapeutics provides and distributes the treatment to patients free of charge in Ebola-stricken countries,” the company states on its website. WHO publishes invitation to drug manufacturers to share drugs for evaluation WHO says it has now published the first invitation to manufacturers of therapeutics against Ebola virus disease to share their drugs for evaluation by the WHO Prequalification Unit, a crucial step to enabling bulk procurement of new drugs by global health agencies, for communities and countries affected by Ebola. “We have seen incredible advances in both the quality and safety of clinical care during Ebola outbreaks,” said Dr Janet Diaz, lead of the clinical management unit in WHO’s Health Emergencies program. “Doing the basics well, including early diagnosis, providing optimized supportive care with the evaluation of new therapeutics under clinical trials, has transformed what is possible during Ebola outbreaks,” she said. “This is what has led to development of a new standard of care for patients. However, timely access to these lifesaving interventions has to be a priority.” WHO also says there is a need for more research and evaluation of clinical interventions because of the large number of “uncertainties” that remain including with supportive care, with our understanding and characterization of the Ebola virus disease and its longer-term consequences, with the continued inclusion of vulnerable populations such as pregnant women, newborns, children and older people in future research. Back to the DRC for More Research, Studies on Ebola treatment The clinical trials used to shape WHO’S guidelines for Ebola treatment were conducted during the Ebola outbreaks that have raged in central and west Africa over the past six years; the largest trial was conducted in the Democratic Republic of the Congo (DRC) which saw a major outbreak in 2018-2020, as well as small outbreaks since then. Ebola is a severe and too often fatal illness, and previous outbreaks and responses showed the importance of early diagnosis and treatment with optimized supportive care that includes fluid and electrolyte repletion and treatment of symptoms. “This therapeutic guide is a critical tool to fight Ebola,” said Dr Richard Kojan, co-chair of the Guideline Development Group of experts selected by WHO and President of ALIMA, The Alliance for International Medical Action. “It will help reassure the communities, health care workers and patients, that this life-threatening disease can be treated thanks to effective drugs,” said Kojan. “From now on, people infected with the Ebola virus will have a greater chance of recovering if they seek care as early as possible,” he said. “As with other infectious diseases, timeliness is key, and people should not hesitate to consult health workers as quickly as possible to ensure they receive the best care possible.” The DRC has now recorded 14 Ebola outbreaks since 1976, including six since 2018. The most recent outbreak, which began in April, was declared to be over by DRC and WHO authorities last month — with fewer cases and deaths (five) than previous episodes due to a swift response including vaccinations. Vaccinations were launched less than a week after the outbreak was declared, using an ultra-cold chain freezer in Mbandaka so vaccine doses could be stored locally and safely, and delivered effectively. That enabled 2,104 people to be vaccinated, including 1,307 frontline workers and 302 contacts. In the previous outbreak in Equateur Province from June to November 2020, 130 people were infected and 55 died. Africa’s battles with Ebola and other deadly diseases also helped prepare its health systems to deal with COVID-19. When SARS-CoV2 virus landed on the continent, the African Centres for Disease Control (CDC) reinforced its regional coordinating centers, enhanced lab capacity and unified surveillance networks. An Additional Tool for Ebola treatment Along With Clinical Care Guidance The new Ebola treatment guidelines are meant to complement clinical care guidance that outlines the optimized supportive care Ebola patients should receive including factors such as relevant tests, pain management, nutrition and co-infections. But the recommendations only apply to the Ebola virus disease caused by Ebola virus (EBOV; Zaire ebolavirus). “Advances in supportive care and therapeutics over the past decade have revolutionized the treatment of Ebola. Ebola virus disease used to be perceived as a near certain killer. However, that is no longer the case,” said Dr Robert Fowler of the University of Toronto and co-chair of the Guideline Development Group of experts selected by WHO. “Provision of best supportive medical care to patients, combined with monoclonal antibody treatment — MAb114 or REGN-EB3 — now leads to recovery for the vast majority of people,” he said. Image Credits: Photo: Anna Dubuis / DFID, WHO Therapeutics for Ebola virus disease. 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 Submits Reguest to US FDA for Approval of Omicron-targeted COVID Booster Shot 23/08/2022 Zachary Brennan, via Endpoints News Albert Bourla, CEO of Pfizer, at a World Economic Forum meeting in 2018. The Omicron-targeted boosters are coming. Almost 250 days since Omicron became the dominant variant in the US, Pfizer and BioNTech on Monday officially announced that they’ve requested an Emergency Use Authorization (EUA) from the US Food and Drug Administration for their booster dose of an Omicron BA.4/BA.5-adapted bivalent vaccine for those 12 and older. The application’s submission comes as BioNTech said earlier this month that it expects to begin delivering Omicron-adapted vaccines as early as October, subject to regulatory approval. The FDA’s vaccine advisory committee in late June gave the thumbs up — by a vote of 19-2 — to requiring an Omicron-related component in this season’s booster dose; both Pfizer/BioNTech and Moderna have been working on such boosters over the past few months. The EUA for Pfizer/BioNTech’s booster would be based on preclinical data showing that it generated a strong neutralizing antibody response against the BA.4/BA.5 variants, as well as safety, tolerability and immunogenicity data from a Phase II/III trial of a 30-µg booster dose of the companies’ other, Omicron BA.1-adapted bivalent vaccine candidate. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month, Pfizer and BioNTech said. FDA to Pfizer: Test another course of Paxlovid for those rebounding In other COVID-related drug developments, the FDA earlier this month quietly called on Pfizer to test another course of its Covid-19 antiviral Paxlovid for those who have rebounded and tested positive after an initial dose. On Aug. 5, the FDA reissued its EUA letter for Paxlovid to include additional post-authorization requirements, including calling on Pfizer “to conduct a clinical trial in patients with ‘COVID-19 rebound’ and a clinical trial evaluating different durations of treatment in immunocompromised patients with mild-to-moderate Covid-19.” Pfizer told Bloomberg News that it is “working with the FDA to finalize a protocol to study patients who may be in need of retreatment,” and the trial protocol is expected to be finalized this month. FDA expands Novavax EUA for teenagers Additionally, US teenagers looking for an option outside of the mRNA Covid-19 vaccines will now be able to turn to Novavax’s Covid-19 vaccine which won an expanded EUA on Friday from the FDA. Those aged 12 through 17 will gain access to the Novavax vaccine after the company submitted data from an ongoing pediatric expansion of its Phase III trial of 2,247 adolescents within that same age range across 75 sites in the US. The company said that in this population the vaccine achieved its primary efficacy endpoint, with clinical efficacy of about 78% (95% CI: 37.55%, 92.45%) overall, at a time when the Delta variant was the predominant circulating variant. The efficacy analysis was supported by assessment of antibody titers that were shown to be higher in adolescents than in young adults, Novavax added. Canada buys 12M doses of Moderna’s Omicron-targeted booster Meanwhile, mRNA powerhouse Moderna said Monday that Canada’s government has exercised its option to purchase an additional 4.5 million doses of an Omicron-containing bivalent vaccine booster candidate, in addition to moving forward the scheduled delivery of 1.5 million doses of the bivalent vaccine candidate from 2023 to 2022. Moderna and Canada also agreed to shift six million doses of the current vaccine to the Omicron-containing vaccine, subject to regulatory approval, with doses scheduled for delivery this year. The vaccine is expected to be ready for deployment in the US in October. ______________________________________________________ This article was first published by Endpoints News. Image Credits: Flickr – World Economic Forum. WHO Warns of New Ebola Threat in DRC 23/08/2022 John Heilprin A health worker in Democratic Republic of the Congo’s eastern province of North Kivu. A new case of Ebola has been confirmed in the Democratic Republic of the Congo’s eastern province of North Kivu, prompting health authorities to declare a resurgence of the deadly virus, World Health Organization (WHO) officials said on Tuesday. WHO announced that health authorities confirmed a 46-year-old woman died of the disease on 15 August in Beni, a town located in North Kivu. She initially received care for other ailments at the Beni Referral Hospital, who said, but the began exhibiting symptoms consistent with Ebola. A statement from WHO said both the Beni and Goma branches of the DRC’s National Institute of Biomedical Research (INRB) confirmed Ebola virus in samples taken from the patient. Further analysis showed her death was genetically linked to the 2018-2020 outbreak in North Kivu and Ituri provinces that was the country’s longest and largest. Last week, WHO issued its first guidelines ever for Ebola treatment. It advised using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease,” WHO says. That includes older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth. Dr Matshidiso Moeti, WHO Africa Executive Director. Battling ‘Greater Frequency’ of Resurgent Ebola Cases This latest resurgence comes just four months after the Ebola outbreak that erupted on 23 April in DRC was declared to be over by DRC and WHO authorities, with fewer cases and deaths than previous episodes due to a swift response including vaccinations. The last time the disease flared up in Beni it was brought under control in about two months and ended in mid-December 2021, after causing six deaths among eight confirmed and three probable cases. “Ebola resurgences are occurring with greater frequency in the Democratic Republic of the Congo which is concerning,” said Dr Matshidiso Moeti, World Health Organization (WHO) Regional Director for Africa. “However, health authorities in North Kivu have successfully stopped several Ebola flareups and, building on this expertise, will no doubt bring this one under control quickly,” Moeti said. Some 160 people have been identified as contacts and their health is being closely monitored by WHO staff and DRC health authorities, WHO said, and it has not yet been determined whether the woman who died was vaccinated. The nation has 1,000 doses of the rVSV-ZEBOV Ebola vaccine in its stockpile, including 200 that are being shipped to Beni this week. Ebola, which is spread by contact with the bodily fluids of an infected person or contaminated materials, produces early symptoms of fever and muscle aches like malaria. WHO’s “ring vaccination” strategy — vaccinating people who came into contact with patients — is expected to begin shortly after having shown some effectiveness at preventing new cases and limiting the spread of the disease in the DRC. WHO has been supporting DRC’s government to scale up testing, contact tracing and public health measures. Stockpiles of Ebola vaccines from the cities of Goma and Kinshasa were transported to Mbandaka earlier this year so vaccinations could start. A targeted Ebola vaccination campaign aimed at tracing and immunizing contacts was underway in Mbandaka, a city in DR Congo’s north-western Equateur Province. Image Credits: WHO. WHO Advocates Prevention Focus in Africa 23/08/2022 Paul Adepoju & John Heilprin WHO Director-General Dr Tedros Adhanom Ghebreyesus at the opening of the 72nd session of the Regional Committee for Africa African nations need to pivot to prevention in their fight against disease by “addressing its root causes” through a greater focus on improved diets, healthier environments, and better road safety, among other factors, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the 72nd WHO Regional Committee for Africa meeting, at the opening of the weeklong session of member states in Togo’s capital Lomé. Tedros also pledged WHO’s continued support for the work of the African Centers of Disease Control (Africa CDC) in remarks aimed at squelching tensions between the two agencies that emerged earlier this summer. Africa CDC began circulating a proposal for it to be empowered by the African Union to declare continental health emergencies, something WHO reportedly opposed. The Fuss Over Who Should Declare Public Health Emergencies in Africa This week’s meeting of African health ministers and government officials is supposed to focus on ways to lower the burden of disease, strengthen capacity and endorse strategies in fighting disease and promoting access to health services and people’s well-being. It also is looking at how the continent can improve prevention and battle COVID-19 and a growing number of other health challenges from outbreaks of communicable diseases, conflicts and humanitarian crises, climatic change and chronic diseases. “Realizing our vision for the highest attainable standard of health starts not in the clinic or the hospital, but in schools, streets, supermarkets, households and cities,” Tedros told the meeting. It was his first major appearance since he formally began his second five-term at the helm of the 194-nation UN health agency a week ago. “Much of the work that you do as ministries of health is dealing with the consequences of poor diets, polluted environments, unsafe roads and workplaces, inadequate health literacy, and the aggressive marketing of products that harm health,” he said. “That’s why,” Tedros said, “we are calling on all member states to make an urgent paradigm shift, towards promoting health and well-being and preventing disease by addressing its root causes, and creating the conditions for health to thrive.” Pledging support for Africa CDC and the African Medicines Agency Tedros also pledged WHO’s continued financial and technical support Africa Centers for Disease Control and Prevention (Africa CDC) – noting that he had in fact helped birth the agency with a proposal for its creation at an African Union summit in July 2013 when he was Ethiopia’s foreign minister. “So, Africa CDC is my daughter, and not only me, but WHO and our regional office, all of us, will do everything to strengthen it. The strengthen of continental institutions is very important to the advancement of health and other sectors in our continent,” he said. “In the same way,” he added, “we are also continuing to provide technical and financial support to the African Medicines Agency (AMA), to support greater regulatory capacity on the continent,” he added, of the new medicines agency that is supposed to help facilitate the more rapid and harmonized approval of new drugs and vaccines across Africa. Cessouma Minata Samate, AU’s Commissioner for Health, Humanitarian Affairs, and Social Development, at the opening ceremony of the 72nd session of the Regional Committee for Africa Last month, Health Policy Watch reported that the Executive Council of the African Union (AU) selected Rwanda to host the headquarters of the African Medicines Agency. Cessouma Minata Samate, AU’s Commissioner for Health, Humanitarian Affairs, and Social Development, said the AMA also aims to support the production of medicines on the African continent. “Through this agency, we are going to build the regulatory capacity of member states of the African Union and the regional economic community,” she said. While congratulating the government of Rwanda for being selected to host AMA’s headquarters, she urged the country to ensure the agency becomes operational as soon as possible. See our special coverage of the development of the AMA here: African Medicines Agency Countdown From prevention to battling inequity Dr Matshidiso Moeti, WHO’s Regional Director for Africa, noted the COVID-19 pandemic showed just how important it is for African countries to invest in health care and fighting diseases. In Africa last year, 22 million jobs were lost and 30 million more people were added to the ranks of extreme poverty, which is defined by the World Bank as living on less than US$1.90 a day. With things expected to continue this way into next year, she said, “these statistics make the case for investment in health very clear.” Inequity is a key factor impeding Africa’s health progress, according to Moeti, whether it is the lack of tools needed for prevention and responses to pandemics or the high out-of-pocket payments that prevent people from seeking health care when they need it. Moeti expressed continued WHO concern about the continent’s comparatively lower COVID-19 vaccination rate despite the recent availability of large quantities of doses. She said it puts health and jobs at unnecessary risk while opening the door to the emergence of new, potentially dangerous variants of the virus. “A fresh impetus to accelerate COVID-19 vaccine uptake is imperative, especially to safeguard our most vulnerable,” she said. Togo’s President Faure Gnassingbé at the opening ceremony of the 72nd session of the Regional Committee for Africa Togo eradicates four NTDs while fighting disease A highlight of the opening ceremony was the recognition of Togo’s efforts at disease prevention including the eradication of four neglected tropical diseases (NTDs). “The liberation of Togo from Dracunculiasis (Guinea-worm disease), Human African Trypanosomiasis, lymphatic filariasis and trachoma is a stunning achievement that will free many people from the threat of these devastating diseases,” Tedros said. “I also congratulate you,” he added,” “for the progress you have made in improving the management and efficiency of hospitals, and for increasing access to services for the population.” Togo’s President Faure Gnassingbé said health is at the center of his government’s development — and is a priority for social cohesion. He described Togo’s relationship with WHO as one that has transcended beyond institutional cooperation and is now a genuine partnership that supports Togo’s health systems, helping to coordinate emergency responses and to raise vaccine equity. “It is a partnership that guides us — learning from current crises with a view to sustainable, equitable and sound solutions,” he said. Image Credits: WHO. Monkeypox Vaccine: 62% of Recipients Experience No Side Effects, Says New Survey 22/08/2022 Maayan Hoffman Jynneos Monkeypox Vaccine A first-of-its-kind survey examining the side effects of the monkeypox vaccine in Israel found that the majority of recipients had no general symptoms. “Most of the side effects reported by the vaccinated are local and mild, which in most cases pass within one to three days,” said Miri Mizrahi Reuveni, Deputy CEO and Head of the Health Division at Maccabi Healthcare Services, which conducted the survey. Maccabi is one of Israel’s four major public health funds. This is some of the first data to be systematically reported on side effects of the vaccine and uptake since the outbreak began, however, the data does not reflect on the vaccine’s efficacy which will take more time to assess. Specifically, some 62% of 155 vaccine recipients reported a return to routine without any general symptoms, Maccabi reported on Monday. The other 38% experienced side effects. Among those who experienced side effects, most fell into broad categories: 27% reported weakness and fatigue; 11% complained of muscle pain; 9% had headaches; 6% suffered from diarrhea; 5% got nausea; 4% had less appetite and swelling of the lymph nodes; 3% felt chills and joint pain; 1% got a skin rash; and another 1% felt eye irritation. A majority of recipients, or 74%, experienced pain at the site of injection, including stiffness (22%), localized swelling (7%) and itching (6%). In most cases, those who experienced side effects said they lasted more than 24 hours. But 22% of recipients who had symptoms said they persist today. Only 3 percent reported that their symptoms passed in less than 24 hours. About 10% said they lasted one day; 39% said they ended within two to three days; and 19% complained of symptoms that took four to six days to resolve. Eight-five percent of respondents said they had no hesitation about getting the jab. The health fund also asked people why they decided to get vaccinated. The most common responses were a desire to protect themselves and those around them. More than a third said they also were afraid of becoming isolated. More than people who belong to the HMO have taken the vaccine already, according to Reuveni. The survey began when the country started distributing the vaccine at the start of August. Respondents were asked questions after they got the shot and seven days later. As of the end of last week, the Israeli Health Ministry reported 197 cases of monkeypox in the country, all of them involving men. Ministry officials told Health Policy Watch on Monday that so far more than 2,300 Israelis have been vaccinated against the virus. The country recently expanded its vaccination criteria to allow more people to get the shot. Israel ordered 10,000 vaccine doses, of which a little more than half have arrived. Some 4,400 vaccine doses are expected to arrive at the beginning of September, ministry officials said. The international monkeypox outbreak began on May 4 when a first case outside of historically endemic African countries was discovered in London. Since then, it has spread across the world, according to the World Health Organization (WHO), with more than 35,000 cases of monkeypox reported from 92 countries and territories accompanied by 12 deaths. WHO Monkeypox Dashboard as of 22 August 2022 Image Credits: Star919News/Twitter , WHO. Open Access 240 Compound Collection Launched in Fight Against Infectious and Mosquito-Borne Illnesses for World Mosquito Day 22/08/2022 Raisa Santos Aedes aegypti mosquito can spread Zika fever, dengue, and other diseases. To mark World Mosquito Day, 20 August, the Global Health Priority Box has been launched to provide free access to 240 compounds to stimulate research into new drugs and insecticides. The initiative, launched by the Medicines for Malaria Venture (MMV) and the Innovative Vector Control Consortium (IVCC), provides scientists with starting points to advance the development of tools that can tackle several priorities set out by the WHO in late 2021, including drug resistance and communicable diseases. Every year vector-borne diseases such as malaria cause the loss of more than 700,000 lives annually, predominantly in regions with tropical climates in low- and middle-income countries. Major vector-borne diseases account for 17% of the global burden of communicable diseases. Recent studies have shown that climate change has the potential to shift the regions in which disease-carrying mosquitoes breed, introducing new pathogens to previously unaffected areas. For example, the spread of malaria, caused by a parasite that spreads to humans and other animals through the bites of infected female mosquitoes, increases in temperatures of around 25ºC. Coupled with the increasing prevalence of drug-resistant superbugs and insecticide resistance, it is clear that new tools are needed to fight against vector-borne diseases. “Efforts to end infectious diseases will only succeed if we have the tools to treat and prevent them,” said Dr Timothy Wells, MMV’s Chief Scientific Officer. Collection of compounds for malaria, neglected and zoonotic diseases, and more The collection features 240 compounds that can be used against drug-resistant malaria, neglected and zoonotic diseases, and other diseases at risk of drug resistance. This includes: 80 compounds with confirmed activity against drug-resistant malaria. 80 compounds for screening against neglected and zoonotic diseases, and diseases at risk of drug resistance. 80 compounds that have been tested for activity against various vector species. Priority Box’s ‘open approach’ emphasizes international collaboration The Global Health Priority Box’s builds on the reaction of the scientific community to the COVID-19 pandemic, which demonstrated that international collaboration accelerates the development of new tools, diagnostics and vaccines. Its open approach invites scientists to make screening results publicly available and to publish findings in an open access journal within two years following data generation. Such an approach allows for researchers around the world to build on one another’s work, saving time and resources. “Open innovation is one of the keys to unlocking drug discovery because it allows us to tap into existing knowledge and expertise and build on it collaboratively,” said Wells. Dr Nick Hamon, CEO of IVCC, noted the need for innovation in vector control due to the increased prevalence of insecticide resistance, “which is undermining the efficacy of bed nets and indoor residual sprays, the cornerstone of malaria prevention since the turn of the century.” “Open access to new chemistry will encourage greater collaboration across the scientific community, bringing new innovators into public health and potentially more rapid development of new vector control solutions,” he said. Image Credits: Sanofi Pasteur/Flickr. WHO Recommends Two Monoclonal Antibodies for Ebola Treatment; Calls to Expand Access in Developing Countries 19/08/2022 John Heilprin A health worker dresses in protective clothing to enter the treatment unit for a suspected Ebola case at western Uganda’s Bwera General Hospital in August 2019 – during the 2018-2020 Ebola outbreak in the neighboring Democratic Republic of Congo. In its first guidelines ever for Ebola treatment, the World Health Organization (WHO) advises using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease, including older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth,” WHO says. In its launch of the recommendations, WHO also called on the global community “to increase access to these lifesaving medicines”. As relatively new therapies, monoclonal antibodies have been difficult and expensive to access in low- and middle-income countries, with 80% of their sales occuring in the US, Canada and Europe. In 2020, a consortium of research organizations, led by Wellcome Trust issued a global call to action to expand access. Yes to Ansuvimab and Inmazeb, No to ZMapp and Remdesivir Patients should receive recommended neutralizing monoclonal antibodies as soon as possible after laboratory confirmation of diagnosis, according to WHO. Its new 44-page guidelines for Ebola treatment also makes a “conditional recommendation against” the use of ZMapp and remdesivir for patients with the Ebola virus. ZMapp, a drug cocktail of antibodies developed from the tobacco plant, was the first drug to be used on an experimental basis against the Ebola virus. Initially it showed promise with rhesus monkeys, but was not fully tested on humans. During the 2014-2016 Ebola epidemic in West Africa, however, the US Food and Drug Administration (FDA) approved ZMapp’s experimental use on patients. That epidemic, the continent’s largest ever, killed more than 11,000 people out of the 28,000 people who became ill with the virus. Subsequently, ZMapp, remdesivir as well as mAb114 and REGN-EB3 were all tested against one another in a randomized controlled trial in the Democratic Republic of Congo, running in parallel to the Ebola epidemic that wracked the eastern region of the country between 2018-2020. In August 2019, however, an independent monitoring board recommended early termination of the DRC therapeutics trial due to the favorable results demonstrated by the latter two drug candidates. The board recommended that all patients be randomized to receive either REGN-EB3 or mAb114 in an extension phase. The study’s preliminary results among 499 participants showed people who got REGN-EB3 or mAb114 had a greater chance of survival than those who received ZMapp or remdesivir. Remdesivir was originally developed to treat hepatitis C before it was investigated for treating the Ebola and Marburg viruses, and then as a post-infection treatment for COVID‑19. It eventually won US and European Medicines Agency approval as a COVID-19 treatment. However, in November 2020, WHO recommended against Remdesivir use for COVID, saying there was “no evidence” it improved patient outcomes. Access remains a problem for ebola treatment In its recommendations, WHO called for greater efforts to ensure that that the drugs are “where patients need them the most: where there is an active Ebola outbreak, or where the threat of outbreaks is high or very likely.” To assist with that goal, WHO offered to support “countries, manufacturers and partners” to step up national and global efforts to increase affordability of the biotherapeutic products. “Access to these therapeutics is challenging and pricing and future supply remain unknown, especially in resource-poor areas,” WHO says in its 44-page guidelines. “Without concerted effort, access will remain limited, and it is therefore possible that this strong recommendation could exacerbate health inequity,” it says. “Therefore, given the demonstrated benefits for patients, these recommendations should act as a stimulus to engage all possible mechanisms to improve global access to these treatments.” Both Inmazeb and Ebanga were developed with significant US government support The development of both Inmazeb and Ebanga was heavily supported by the US government and other public funders. Inmazeb, which also was the first FDA-approved treatment for Ebola, is produced by the US-based Regeneron Pharmaceuticals. It was developed in response to the 2018 Ebola outbreak in the DRC with supprot from the US Biomedical Advanced Research and Development Authority (BARDA). Regeneron announced in 2020, the company will “continue to provide Inmazeb for free in response to outbreaks in the DRC through the MEURI protocol for compassionate use,” in colaboration with the WHO, the US FDA and with continuing support from BARDA. “Regeneron is actively working with nongovernmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries,” the company declared at that time. The MEURI protocol is a WHO-approved ethical framework for the use of investigational agents. Regeneron gained fame in the first year of the COVID pandemic when former President Donald Trump was treated with another antibody cocktail that it had developed against COVID, (REGEN-COV- a combination of casirivimab and imdevimab) . The cocktail was later recommended by WHO for COVID treatment. As for Ebanga, it was initially developed by the Vaccine Research Center of the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), and then licensed in 2018 by the US biotech firm, Ridgeback Biotherapeutics for further development and ultimately FDA aprpoval. “Ebanga is currently available to patients, and Ridgeback Biotherapeutics provides and distributes the treatment to patients free of charge in Ebola-stricken countries,” the company states on its website. WHO publishes invitation to drug manufacturers to share drugs for evaluation WHO says it has now published the first invitation to manufacturers of therapeutics against Ebola virus disease to share their drugs for evaluation by the WHO Prequalification Unit, a crucial step to enabling bulk procurement of new drugs by global health agencies, for communities and countries affected by Ebola. “We have seen incredible advances in both the quality and safety of clinical care during Ebola outbreaks,” said Dr Janet Diaz, lead of the clinical management unit in WHO’s Health Emergencies program. “Doing the basics well, including early diagnosis, providing optimized supportive care with the evaluation of new therapeutics under clinical trials, has transformed what is possible during Ebola outbreaks,” she said. “This is what has led to development of a new standard of care for patients. However, timely access to these lifesaving interventions has to be a priority.” WHO also says there is a need for more research and evaluation of clinical interventions because of the large number of “uncertainties” that remain including with supportive care, with our understanding and characterization of the Ebola virus disease and its longer-term consequences, with the continued inclusion of vulnerable populations such as pregnant women, newborns, children and older people in future research. Back to the DRC for More Research, Studies on Ebola treatment The clinical trials used to shape WHO’S guidelines for Ebola treatment were conducted during the Ebola outbreaks that have raged in central and west Africa over the past six years; the largest trial was conducted in the Democratic Republic of the Congo (DRC) which saw a major outbreak in 2018-2020, as well as small outbreaks since then. Ebola is a severe and too often fatal illness, and previous outbreaks and responses showed the importance of early diagnosis and treatment with optimized supportive care that includes fluid and electrolyte repletion and treatment of symptoms. “This therapeutic guide is a critical tool to fight Ebola,” said Dr Richard Kojan, co-chair of the Guideline Development Group of experts selected by WHO and President of ALIMA, The Alliance for International Medical Action. “It will help reassure the communities, health care workers and patients, that this life-threatening disease can be treated thanks to effective drugs,” said Kojan. “From now on, people infected with the Ebola virus will have a greater chance of recovering if they seek care as early as possible,” he said. “As with other infectious diseases, timeliness is key, and people should not hesitate to consult health workers as quickly as possible to ensure they receive the best care possible.” The DRC has now recorded 14 Ebola outbreaks since 1976, including six since 2018. The most recent outbreak, which began in April, was declared to be over by DRC and WHO authorities last month — with fewer cases and deaths (five) than previous episodes due to a swift response including vaccinations. Vaccinations were launched less than a week after the outbreak was declared, using an ultra-cold chain freezer in Mbandaka so vaccine doses could be stored locally and safely, and delivered effectively. That enabled 2,104 people to be vaccinated, including 1,307 frontline workers and 302 contacts. In the previous outbreak in Equateur Province from June to November 2020, 130 people were infected and 55 died. Africa’s battles with Ebola and other deadly diseases also helped prepare its health systems to deal with COVID-19. When SARS-CoV2 virus landed on the continent, the African Centres for Disease Control (CDC) reinforced its regional coordinating centers, enhanced lab capacity and unified surveillance networks. An Additional Tool for Ebola treatment Along With Clinical Care Guidance The new Ebola treatment guidelines are meant to complement clinical care guidance that outlines the optimized supportive care Ebola patients should receive including factors such as relevant tests, pain management, nutrition and co-infections. But the recommendations only apply to the Ebola virus disease caused by Ebola virus (EBOV; Zaire ebolavirus). “Advances in supportive care and therapeutics over the past decade have revolutionized the treatment of Ebola. Ebola virus disease used to be perceived as a near certain killer. However, that is no longer the case,” said Dr Robert Fowler of the University of Toronto and co-chair of the Guideline Development Group of experts selected by WHO. “Provision of best supportive medical care to patients, combined with monoclonal antibody treatment — MAb114 or REGN-EB3 — now leads to recovery for the vast majority of people,” he said. Image Credits: Photo: Anna Dubuis / DFID, WHO Therapeutics for Ebola virus disease. 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.
WHO Warns of New Ebola Threat in DRC 23/08/2022 John Heilprin A health worker in Democratic Republic of the Congo’s eastern province of North Kivu. A new case of Ebola has been confirmed in the Democratic Republic of the Congo’s eastern province of North Kivu, prompting health authorities to declare a resurgence of the deadly virus, World Health Organization (WHO) officials said on Tuesday. WHO announced that health authorities confirmed a 46-year-old woman died of the disease on 15 August in Beni, a town located in North Kivu. She initially received care for other ailments at the Beni Referral Hospital, who said, but the began exhibiting symptoms consistent with Ebola. A statement from WHO said both the Beni and Goma branches of the DRC’s National Institute of Biomedical Research (INRB) confirmed Ebola virus in samples taken from the patient. Further analysis showed her death was genetically linked to the 2018-2020 outbreak in North Kivu and Ituri provinces that was the country’s longest and largest. Last week, WHO issued its first guidelines ever for Ebola treatment. It advised using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease,” WHO says. That includes older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth. Dr Matshidiso Moeti, WHO Africa Executive Director. Battling ‘Greater Frequency’ of Resurgent Ebola Cases This latest resurgence comes just four months after the Ebola outbreak that erupted on 23 April in DRC was declared to be over by DRC and WHO authorities, with fewer cases and deaths than previous episodes due to a swift response including vaccinations. The last time the disease flared up in Beni it was brought under control in about two months and ended in mid-December 2021, after causing six deaths among eight confirmed and three probable cases. “Ebola resurgences are occurring with greater frequency in the Democratic Republic of the Congo which is concerning,” said Dr Matshidiso Moeti, World Health Organization (WHO) Regional Director for Africa. “However, health authorities in North Kivu have successfully stopped several Ebola flareups and, building on this expertise, will no doubt bring this one under control quickly,” Moeti said. Some 160 people have been identified as contacts and their health is being closely monitored by WHO staff and DRC health authorities, WHO said, and it has not yet been determined whether the woman who died was vaccinated. The nation has 1,000 doses of the rVSV-ZEBOV Ebola vaccine in its stockpile, including 200 that are being shipped to Beni this week. Ebola, which is spread by contact with the bodily fluids of an infected person or contaminated materials, produces early symptoms of fever and muscle aches like malaria. WHO’s “ring vaccination” strategy — vaccinating people who came into contact with patients — is expected to begin shortly after having shown some effectiveness at preventing new cases and limiting the spread of the disease in the DRC. WHO has been supporting DRC’s government to scale up testing, contact tracing and public health measures. Stockpiles of Ebola vaccines from the cities of Goma and Kinshasa were transported to Mbandaka earlier this year so vaccinations could start. A targeted Ebola vaccination campaign aimed at tracing and immunizing contacts was underway in Mbandaka, a city in DR Congo’s north-western Equateur Province. Image Credits: WHO. WHO Advocates Prevention Focus in Africa 23/08/2022 Paul Adepoju & John Heilprin WHO Director-General Dr Tedros Adhanom Ghebreyesus at the opening of the 72nd session of the Regional Committee for Africa African nations need to pivot to prevention in their fight against disease by “addressing its root causes” through a greater focus on improved diets, healthier environments, and better road safety, among other factors, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the 72nd WHO Regional Committee for Africa meeting, at the opening of the weeklong session of member states in Togo’s capital Lomé. Tedros also pledged WHO’s continued support for the work of the African Centers of Disease Control (Africa CDC) in remarks aimed at squelching tensions between the two agencies that emerged earlier this summer. Africa CDC began circulating a proposal for it to be empowered by the African Union to declare continental health emergencies, something WHO reportedly opposed. The Fuss Over Who Should Declare Public Health Emergencies in Africa This week’s meeting of African health ministers and government officials is supposed to focus on ways to lower the burden of disease, strengthen capacity and endorse strategies in fighting disease and promoting access to health services and people’s well-being. It also is looking at how the continent can improve prevention and battle COVID-19 and a growing number of other health challenges from outbreaks of communicable diseases, conflicts and humanitarian crises, climatic change and chronic diseases. “Realizing our vision for the highest attainable standard of health starts not in the clinic or the hospital, but in schools, streets, supermarkets, households and cities,” Tedros told the meeting. It was his first major appearance since he formally began his second five-term at the helm of the 194-nation UN health agency a week ago. “Much of the work that you do as ministries of health is dealing with the consequences of poor diets, polluted environments, unsafe roads and workplaces, inadequate health literacy, and the aggressive marketing of products that harm health,” he said. “That’s why,” Tedros said, “we are calling on all member states to make an urgent paradigm shift, towards promoting health and well-being and preventing disease by addressing its root causes, and creating the conditions for health to thrive.” Pledging support for Africa CDC and the African Medicines Agency Tedros also pledged WHO’s continued financial and technical support Africa Centers for Disease Control and Prevention (Africa CDC) – noting that he had in fact helped birth the agency with a proposal for its creation at an African Union summit in July 2013 when he was Ethiopia’s foreign minister. “So, Africa CDC is my daughter, and not only me, but WHO and our regional office, all of us, will do everything to strengthen it. The strengthen of continental institutions is very important to the advancement of health and other sectors in our continent,” he said. “In the same way,” he added, “we are also continuing to provide technical and financial support to the African Medicines Agency (AMA), to support greater regulatory capacity on the continent,” he added, of the new medicines agency that is supposed to help facilitate the more rapid and harmonized approval of new drugs and vaccines across Africa. Cessouma Minata Samate, AU’s Commissioner for Health, Humanitarian Affairs, and Social Development, at the opening ceremony of the 72nd session of the Regional Committee for Africa Last month, Health Policy Watch reported that the Executive Council of the African Union (AU) selected Rwanda to host the headquarters of the African Medicines Agency. Cessouma Minata Samate, AU’s Commissioner for Health, Humanitarian Affairs, and Social Development, said the AMA also aims to support the production of medicines on the African continent. “Through this agency, we are going to build the regulatory capacity of member states of the African Union and the regional economic community,” she said. While congratulating the government of Rwanda for being selected to host AMA’s headquarters, she urged the country to ensure the agency becomes operational as soon as possible. See our special coverage of the development of the AMA here: African Medicines Agency Countdown From prevention to battling inequity Dr Matshidiso Moeti, WHO’s Regional Director for Africa, noted the COVID-19 pandemic showed just how important it is for African countries to invest in health care and fighting diseases. In Africa last year, 22 million jobs were lost and 30 million more people were added to the ranks of extreme poverty, which is defined by the World Bank as living on less than US$1.90 a day. With things expected to continue this way into next year, she said, “these statistics make the case for investment in health very clear.” Inequity is a key factor impeding Africa’s health progress, according to Moeti, whether it is the lack of tools needed for prevention and responses to pandemics or the high out-of-pocket payments that prevent people from seeking health care when they need it. Moeti expressed continued WHO concern about the continent’s comparatively lower COVID-19 vaccination rate despite the recent availability of large quantities of doses. She said it puts health and jobs at unnecessary risk while opening the door to the emergence of new, potentially dangerous variants of the virus. “A fresh impetus to accelerate COVID-19 vaccine uptake is imperative, especially to safeguard our most vulnerable,” she said. Togo’s President Faure Gnassingbé at the opening ceremony of the 72nd session of the Regional Committee for Africa Togo eradicates four NTDs while fighting disease A highlight of the opening ceremony was the recognition of Togo’s efforts at disease prevention including the eradication of four neglected tropical diseases (NTDs). “The liberation of Togo from Dracunculiasis (Guinea-worm disease), Human African Trypanosomiasis, lymphatic filariasis and trachoma is a stunning achievement that will free many people from the threat of these devastating diseases,” Tedros said. “I also congratulate you,” he added,” “for the progress you have made in improving the management and efficiency of hospitals, and for increasing access to services for the population.” Togo’s President Faure Gnassingbé said health is at the center of his government’s development — and is a priority for social cohesion. He described Togo’s relationship with WHO as one that has transcended beyond institutional cooperation and is now a genuine partnership that supports Togo’s health systems, helping to coordinate emergency responses and to raise vaccine equity. “It is a partnership that guides us — learning from current crises with a view to sustainable, equitable and sound solutions,” he said. Image Credits: WHO. Monkeypox Vaccine: 62% of Recipients Experience No Side Effects, Says New Survey 22/08/2022 Maayan Hoffman Jynneos Monkeypox Vaccine A first-of-its-kind survey examining the side effects of the monkeypox vaccine in Israel found that the majority of recipients had no general symptoms. “Most of the side effects reported by the vaccinated are local and mild, which in most cases pass within one to three days,” said Miri Mizrahi Reuveni, Deputy CEO and Head of the Health Division at Maccabi Healthcare Services, which conducted the survey. Maccabi is one of Israel’s four major public health funds. This is some of the first data to be systematically reported on side effects of the vaccine and uptake since the outbreak began, however, the data does not reflect on the vaccine’s efficacy which will take more time to assess. Specifically, some 62% of 155 vaccine recipients reported a return to routine without any general symptoms, Maccabi reported on Monday. The other 38% experienced side effects. Among those who experienced side effects, most fell into broad categories: 27% reported weakness and fatigue; 11% complained of muscle pain; 9% had headaches; 6% suffered from diarrhea; 5% got nausea; 4% had less appetite and swelling of the lymph nodes; 3% felt chills and joint pain; 1% got a skin rash; and another 1% felt eye irritation. A majority of recipients, or 74%, experienced pain at the site of injection, including stiffness (22%), localized swelling (7%) and itching (6%). In most cases, those who experienced side effects said they lasted more than 24 hours. But 22% of recipients who had symptoms said they persist today. Only 3 percent reported that their symptoms passed in less than 24 hours. About 10% said they lasted one day; 39% said they ended within two to three days; and 19% complained of symptoms that took four to six days to resolve. Eight-five percent of respondents said they had no hesitation about getting the jab. The health fund also asked people why they decided to get vaccinated. The most common responses were a desire to protect themselves and those around them. More than a third said they also were afraid of becoming isolated. More than people who belong to the HMO have taken the vaccine already, according to Reuveni. The survey began when the country started distributing the vaccine at the start of August. Respondents were asked questions after they got the shot and seven days later. As of the end of last week, the Israeli Health Ministry reported 197 cases of monkeypox in the country, all of them involving men. Ministry officials told Health Policy Watch on Monday that so far more than 2,300 Israelis have been vaccinated against the virus. The country recently expanded its vaccination criteria to allow more people to get the shot. Israel ordered 10,000 vaccine doses, of which a little more than half have arrived. Some 4,400 vaccine doses are expected to arrive at the beginning of September, ministry officials said. The international monkeypox outbreak began on May 4 when a first case outside of historically endemic African countries was discovered in London. Since then, it has spread across the world, according to the World Health Organization (WHO), with more than 35,000 cases of monkeypox reported from 92 countries and territories accompanied by 12 deaths. WHO Monkeypox Dashboard as of 22 August 2022 Image Credits: Star919News/Twitter , WHO. Open Access 240 Compound Collection Launched in Fight Against Infectious and Mosquito-Borne Illnesses for World Mosquito Day 22/08/2022 Raisa Santos Aedes aegypti mosquito can spread Zika fever, dengue, and other diseases. To mark World Mosquito Day, 20 August, the Global Health Priority Box has been launched to provide free access to 240 compounds to stimulate research into new drugs and insecticides. The initiative, launched by the Medicines for Malaria Venture (MMV) and the Innovative Vector Control Consortium (IVCC), provides scientists with starting points to advance the development of tools that can tackle several priorities set out by the WHO in late 2021, including drug resistance and communicable diseases. Every year vector-borne diseases such as malaria cause the loss of more than 700,000 lives annually, predominantly in regions with tropical climates in low- and middle-income countries. Major vector-borne diseases account for 17% of the global burden of communicable diseases. Recent studies have shown that climate change has the potential to shift the regions in which disease-carrying mosquitoes breed, introducing new pathogens to previously unaffected areas. For example, the spread of malaria, caused by a parasite that spreads to humans and other animals through the bites of infected female mosquitoes, increases in temperatures of around 25ºC. Coupled with the increasing prevalence of drug-resistant superbugs and insecticide resistance, it is clear that new tools are needed to fight against vector-borne diseases. “Efforts to end infectious diseases will only succeed if we have the tools to treat and prevent them,” said Dr Timothy Wells, MMV’s Chief Scientific Officer. Collection of compounds for malaria, neglected and zoonotic diseases, and more The collection features 240 compounds that can be used against drug-resistant malaria, neglected and zoonotic diseases, and other diseases at risk of drug resistance. This includes: 80 compounds with confirmed activity against drug-resistant malaria. 80 compounds for screening against neglected and zoonotic diseases, and diseases at risk of drug resistance. 80 compounds that have been tested for activity against various vector species. Priority Box’s ‘open approach’ emphasizes international collaboration The Global Health Priority Box’s builds on the reaction of the scientific community to the COVID-19 pandemic, which demonstrated that international collaboration accelerates the development of new tools, diagnostics and vaccines. Its open approach invites scientists to make screening results publicly available and to publish findings in an open access journal within two years following data generation. Such an approach allows for researchers around the world to build on one another’s work, saving time and resources. “Open innovation is one of the keys to unlocking drug discovery because it allows us to tap into existing knowledge and expertise and build on it collaboratively,” said Wells. Dr Nick Hamon, CEO of IVCC, noted the need for innovation in vector control due to the increased prevalence of insecticide resistance, “which is undermining the efficacy of bed nets and indoor residual sprays, the cornerstone of malaria prevention since the turn of the century.” “Open access to new chemistry will encourage greater collaboration across the scientific community, bringing new innovators into public health and potentially more rapid development of new vector control solutions,” he said. Image Credits: Sanofi Pasteur/Flickr. WHO Recommends Two Monoclonal Antibodies for Ebola Treatment; Calls to Expand Access in Developing Countries 19/08/2022 John Heilprin A health worker dresses in protective clothing to enter the treatment unit for a suspected Ebola case at western Uganda’s Bwera General Hospital in August 2019 – during the 2018-2020 Ebola outbreak in the neighboring Democratic Republic of Congo. In its first guidelines ever for Ebola treatment, the World Health Organization (WHO) advises using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease, including older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth,” WHO says. In its launch of the recommendations, WHO also called on the global community “to increase access to these lifesaving medicines”. As relatively new therapies, monoclonal antibodies have been difficult and expensive to access in low- and middle-income countries, with 80% of their sales occuring in the US, Canada and Europe. In 2020, a consortium of research organizations, led by Wellcome Trust issued a global call to action to expand access. Yes to Ansuvimab and Inmazeb, No to ZMapp and Remdesivir Patients should receive recommended neutralizing monoclonal antibodies as soon as possible after laboratory confirmation of diagnosis, according to WHO. Its new 44-page guidelines for Ebola treatment also makes a “conditional recommendation against” the use of ZMapp and remdesivir for patients with the Ebola virus. ZMapp, a drug cocktail of antibodies developed from the tobacco plant, was the first drug to be used on an experimental basis against the Ebola virus. Initially it showed promise with rhesus monkeys, but was not fully tested on humans. During the 2014-2016 Ebola epidemic in West Africa, however, the US Food and Drug Administration (FDA) approved ZMapp’s experimental use on patients. That epidemic, the continent’s largest ever, killed more than 11,000 people out of the 28,000 people who became ill with the virus. Subsequently, ZMapp, remdesivir as well as mAb114 and REGN-EB3 were all tested against one another in a randomized controlled trial in the Democratic Republic of Congo, running in parallel to the Ebola epidemic that wracked the eastern region of the country between 2018-2020. In August 2019, however, an independent monitoring board recommended early termination of the DRC therapeutics trial due to the favorable results demonstrated by the latter two drug candidates. The board recommended that all patients be randomized to receive either REGN-EB3 or mAb114 in an extension phase. The study’s preliminary results among 499 participants showed people who got REGN-EB3 or mAb114 had a greater chance of survival than those who received ZMapp or remdesivir. Remdesivir was originally developed to treat hepatitis C before it was investigated for treating the Ebola and Marburg viruses, and then as a post-infection treatment for COVID‑19. It eventually won US and European Medicines Agency approval as a COVID-19 treatment. However, in November 2020, WHO recommended against Remdesivir use for COVID, saying there was “no evidence” it improved patient outcomes. Access remains a problem for ebola treatment In its recommendations, WHO called for greater efforts to ensure that that the drugs are “where patients need them the most: where there is an active Ebola outbreak, or where the threat of outbreaks is high or very likely.” To assist with that goal, WHO offered to support “countries, manufacturers and partners” to step up national and global efforts to increase affordability of the biotherapeutic products. “Access to these therapeutics is challenging and pricing and future supply remain unknown, especially in resource-poor areas,” WHO says in its 44-page guidelines. “Without concerted effort, access will remain limited, and it is therefore possible that this strong recommendation could exacerbate health inequity,” it says. “Therefore, given the demonstrated benefits for patients, these recommendations should act as a stimulus to engage all possible mechanisms to improve global access to these treatments.” Both Inmazeb and Ebanga were developed with significant US government support The development of both Inmazeb and Ebanga was heavily supported by the US government and other public funders. Inmazeb, which also was the first FDA-approved treatment for Ebola, is produced by the US-based Regeneron Pharmaceuticals. It was developed in response to the 2018 Ebola outbreak in the DRC with supprot from the US Biomedical Advanced Research and Development Authority (BARDA). Regeneron announced in 2020, the company will “continue to provide Inmazeb for free in response to outbreaks in the DRC through the MEURI protocol for compassionate use,” in colaboration with the WHO, the US FDA and with continuing support from BARDA. “Regeneron is actively working with nongovernmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries,” the company declared at that time. The MEURI protocol is a WHO-approved ethical framework for the use of investigational agents. Regeneron gained fame in the first year of the COVID pandemic when former President Donald Trump was treated with another antibody cocktail that it had developed against COVID, (REGEN-COV- a combination of casirivimab and imdevimab) . The cocktail was later recommended by WHO for COVID treatment. As for Ebanga, it was initially developed by the Vaccine Research Center of the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), and then licensed in 2018 by the US biotech firm, Ridgeback Biotherapeutics for further development and ultimately FDA aprpoval. “Ebanga is currently available to patients, and Ridgeback Biotherapeutics provides and distributes the treatment to patients free of charge in Ebola-stricken countries,” the company states on its website. WHO publishes invitation to drug manufacturers to share drugs for evaluation WHO says it has now published the first invitation to manufacturers of therapeutics against Ebola virus disease to share their drugs for evaluation by the WHO Prequalification Unit, a crucial step to enabling bulk procurement of new drugs by global health agencies, for communities and countries affected by Ebola. “We have seen incredible advances in both the quality and safety of clinical care during Ebola outbreaks,” said Dr Janet Diaz, lead of the clinical management unit in WHO’s Health Emergencies program. “Doing the basics well, including early diagnosis, providing optimized supportive care with the evaluation of new therapeutics under clinical trials, has transformed what is possible during Ebola outbreaks,” she said. “This is what has led to development of a new standard of care for patients. However, timely access to these lifesaving interventions has to be a priority.” WHO also says there is a need for more research and evaluation of clinical interventions because of the large number of “uncertainties” that remain including with supportive care, with our understanding and characterization of the Ebola virus disease and its longer-term consequences, with the continued inclusion of vulnerable populations such as pregnant women, newborns, children and older people in future research. Back to the DRC for More Research, Studies on Ebola treatment The clinical trials used to shape WHO’S guidelines for Ebola treatment were conducted during the Ebola outbreaks that have raged in central and west Africa over the past six years; the largest trial was conducted in the Democratic Republic of the Congo (DRC) which saw a major outbreak in 2018-2020, as well as small outbreaks since then. Ebola is a severe and too often fatal illness, and previous outbreaks and responses showed the importance of early diagnosis and treatment with optimized supportive care that includes fluid and electrolyte repletion and treatment of symptoms. “This therapeutic guide is a critical tool to fight Ebola,” said Dr Richard Kojan, co-chair of the Guideline Development Group of experts selected by WHO and President of ALIMA, The Alliance for International Medical Action. “It will help reassure the communities, health care workers and patients, that this life-threatening disease can be treated thanks to effective drugs,” said Kojan. “From now on, people infected with the Ebola virus will have a greater chance of recovering if they seek care as early as possible,” he said. “As with other infectious diseases, timeliness is key, and people should not hesitate to consult health workers as quickly as possible to ensure they receive the best care possible.” The DRC has now recorded 14 Ebola outbreaks since 1976, including six since 2018. The most recent outbreak, which began in April, was declared to be over by DRC and WHO authorities last month — with fewer cases and deaths (five) than previous episodes due to a swift response including vaccinations. Vaccinations were launched less than a week after the outbreak was declared, using an ultra-cold chain freezer in Mbandaka so vaccine doses could be stored locally and safely, and delivered effectively. That enabled 2,104 people to be vaccinated, including 1,307 frontline workers and 302 contacts. In the previous outbreak in Equateur Province from June to November 2020, 130 people were infected and 55 died. Africa’s battles with Ebola and other deadly diseases also helped prepare its health systems to deal with COVID-19. When SARS-CoV2 virus landed on the continent, the African Centres for Disease Control (CDC) reinforced its regional coordinating centers, enhanced lab capacity and unified surveillance networks. An Additional Tool for Ebola treatment Along With Clinical Care Guidance The new Ebola treatment guidelines are meant to complement clinical care guidance that outlines the optimized supportive care Ebola patients should receive including factors such as relevant tests, pain management, nutrition and co-infections. But the recommendations only apply to the Ebola virus disease caused by Ebola virus (EBOV; Zaire ebolavirus). “Advances in supportive care and therapeutics over the past decade have revolutionized the treatment of Ebola. Ebola virus disease used to be perceived as a near certain killer. However, that is no longer the case,” said Dr Robert Fowler of the University of Toronto and co-chair of the Guideline Development Group of experts selected by WHO. “Provision of best supportive medical care to patients, combined with monoclonal antibody treatment — MAb114 or REGN-EB3 — now leads to recovery for the vast majority of people,” he said. 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WHO Advocates Prevention Focus in Africa 23/08/2022 Paul Adepoju & John Heilprin WHO Director-General Dr Tedros Adhanom Ghebreyesus at the opening of the 72nd session of the Regional Committee for Africa African nations need to pivot to prevention in their fight against disease by “addressing its root causes” through a greater focus on improved diets, healthier environments, and better road safety, among other factors, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the 72nd WHO Regional Committee for Africa meeting, at the opening of the weeklong session of member states in Togo’s capital Lomé. Tedros also pledged WHO’s continued support for the work of the African Centers of Disease Control (Africa CDC) in remarks aimed at squelching tensions between the two agencies that emerged earlier this summer. Africa CDC began circulating a proposal for it to be empowered by the African Union to declare continental health emergencies, something WHO reportedly opposed. The Fuss Over Who Should Declare Public Health Emergencies in Africa This week’s meeting of African health ministers and government officials is supposed to focus on ways to lower the burden of disease, strengthen capacity and endorse strategies in fighting disease and promoting access to health services and people’s well-being. It also is looking at how the continent can improve prevention and battle COVID-19 and a growing number of other health challenges from outbreaks of communicable diseases, conflicts and humanitarian crises, climatic change and chronic diseases. “Realizing our vision for the highest attainable standard of health starts not in the clinic or the hospital, but in schools, streets, supermarkets, households and cities,” Tedros told the meeting. It was his first major appearance since he formally began his second five-term at the helm of the 194-nation UN health agency a week ago. “Much of the work that you do as ministries of health is dealing with the consequences of poor diets, polluted environments, unsafe roads and workplaces, inadequate health literacy, and the aggressive marketing of products that harm health,” he said. “That’s why,” Tedros said, “we are calling on all member states to make an urgent paradigm shift, towards promoting health and well-being and preventing disease by addressing its root causes, and creating the conditions for health to thrive.” Pledging support for Africa CDC and the African Medicines Agency Tedros also pledged WHO’s continued financial and technical support Africa Centers for Disease Control and Prevention (Africa CDC) – noting that he had in fact helped birth the agency with a proposal for its creation at an African Union summit in July 2013 when he was Ethiopia’s foreign minister. “So, Africa CDC is my daughter, and not only me, but WHO and our regional office, all of us, will do everything to strengthen it. The strengthen of continental institutions is very important to the advancement of health and other sectors in our continent,” he said. “In the same way,” he added, “we are also continuing to provide technical and financial support to the African Medicines Agency (AMA), to support greater regulatory capacity on the continent,” he added, of the new medicines agency that is supposed to help facilitate the more rapid and harmonized approval of new drugs and vaccines across Africa. Cessouma Minata Samate, AU’s Commissioner for Health, Humanitarian Affairs, and Social Development, at the opening ceremony of the 72nd session of the Regional Committee for Africa Last month, Health Policy Watch reported that the Executive Council of the African Union (AU) selected Rwanda to host the headquarters of the African Medicines Agency. Cessouma Minata Samate, AU’s Commissioner for Health, Humanitarian Affairs, and Social Development, said the AMA also aims to support the production of medicines on the African continent. “Through this agency, we are going to build the regulatory capacity of member states of the African Union and the regional economic community,” she said. While congratulating the government of Rwanda for being selected to host AMA’s headquarters, she urged the country to ensure the agency becomes operational as soon as possible. See our special coverage of the development of the AMA here: African Medicines Agency Countdown From prevention to battling inequity Dr Matshidiso Moeti, WHO’s Regional Director for Africa, noted the COVID-19 pandemic showed just how important it is for African countries to invest in health care and fighting diseases. In Africa last year, 22 million jobs were lost and 30 million more people were added to the ranks of extreme poverty, which is defined by the World Bank as living on less than US$1.90 a day. With things expected to continue this way into next year, she said, “these statistics make the case for investment in health very clear.” Inequity is a key factor impeding Africa’s health progress, according to Moeti, whether it is the lack of tools needed for prevention and responses to pandemics or the high out-of-pocket payments that prevent people from seeking health care when they need it. Moeti expressed continued WHO concern about the continent’s comparatively lower COVID-19 vaccination rate despite the recent availability of large quantities of doses. She said it puts health and jobs at unnecessary risk while opening the door to the emergence of new, potentially dangerous variants of the virus. “A fresh impetus to accelerate COVID-19 vaccine uptake is imperative, especially to safeguard our most vulnerable,” she said. Togo’s President Faure Gnassingbé at the opening ceremony of the 72nd session of the Regional Committee for Africa Togo eradicates four NTDs while fighting disease A highlight of the opening ceremony was the recognition of Togo’s efforts at disease prevention including the eradication of four neglected tropical diseases (NTDs). “The liberation of Togo from Dracunculiasis (Guinea-worm disease), Human African Trypanosomiasis, lymphatic filariasis and trachoma is a stunning achievement that will free many people from the threat of these devastating diseases,” Tedros said. “I also congratulate you,” he added,” “for the progress you have made in improving the management and efficiency of hospitals, and for increasing access to services for the population.” Togo’s President Faure Gnassingbé said health is at the center of his government’s development — and is a priority for social cohesion. He described Togo’s relationship with WHO as one that has transcended beyond institutional cooperation and is now a genuine partnership that supports Togo’s health systems, helping to coordinate emergency responses and to raise vaccine equity. “It is a partnership that guides us — learning from current crises with a view to sustainable, equitable and sound solutions,” he said. Image Credits: WHO. Monkeypox Vaccine: 62% of Recipients Experience No Side Effects, Says New Survey 22/08/2022 Maayan Hoffman Jynneos Monkeypox Vaccine A first-of-its-kind survey examining the side effects of the monkeypox vaccine in Israel found that the majority of recipients had no general symptoms. “Most of the side effects reported by the vaccinated are local and mild, which in most cases pass within one to three days,” said Miri Mizrahi Reuveni, Deputy CEO and Head of the Health Division at Maccabi Healthcare Services, which conducted the survey. Maccabi is one of Israel’s four major public health funds. This is some of the first data to be systematically reported on side effects of the vaccine and uptake since the outbreak began, however, the data does not reflect on the vaccine’s efficacy which will take more time to assess. Specifically, some 62% of 155 vaccine recipients reported a return to routine without any general symptoms, Maccabi reported on Monday. The other 38% experienced side effects. Among those who experienced side effects, most fell into broad categories: 27% reported weakness and fatigue; 11% complained of muscle pain; 9% had headaches; 6% suffered from diarrhea; 5% got nausea; 4% had less appetite and swelling of the lymph nodes; 3% felt chills and joint pain; 1% got a skin rash; and another 1% felt eye irritation. A majority of recipients, or 74%, experienced pain at the site of injection, including stiffness (22%), localized swelling (7%) and itching (6%). In most cases, those who experienced side effects said they lasted more than 24 hours. But 22% of recipients who had symptoms said they persist today. Only 3 percent reported that their symptoms passed in less than 24 hours. About 10% said they lasted one day; 39% said they ended within two to three days; and 19% complained of symptoms that took four to six days to resolve. Eight-five percent of respondents said they had no hesitation about getting the jab. The health fund also asked people why they decided to get vaccinated. The most common responses were a desire to protect themselves and those around them. More than a third said they also were afraid of becoming isolated. More than people who belong to the HMO have taken the vaccine already, according to Reuveni. The survey began when the country started distributing the vaccine at the start of August. Respondents were asked questions after they got the shot and seven days later. As of the end of last week, the Israeli Health Ministry reported 197 cases of monkeypox in the country, all of them involving men. Ministry officials told Health Policy Watch on Monday that so far more than 2,300 Israelis have been vaccinated against the virus. The country recently expanded its vaccination criteria to allow more people to get the shot. Israel ordered 10,000 vaccine doses, of which a little more than half have arrived. Some 4,400 vaccine doses are expected to arrive at the beginning of September, ministry officials said. The international monkeypox outbreak began on May 4 when a first case outside of historically endemic African countries was discovered in London. Since then, it has spread across the world, according to the World Health Organization (WHO), with more than 35,000 cases of monkeypox reported from 92 countries and territories accompanied by 12 deaths. WHO Monkeypox Dashboard as of 22 August 2022 Image Credits: Star919News/Twitter , WHO. Open Access 240 Compound Collection Launched in Fight Against Infectious and Mosquito-Borne Illnesses for World Mosquito Day 22/08/2022 Raisa Santos Aedes aegypti mosquito can spread Zika fever, dengue, and other diseases. To mark World Mosquito Day, 20 August, the Global Health Priority Box has been launched to provide free access to 240 compounds to stimulate research into new drugs and insecticides. The initiative, launched by the Medicines for Malaria Venture (MMV) and the Innovative Vector Control Consortium (IVCC), provides scientists with starting points to advance the development of tools that can tackle several priorities set out by the WHO in late 2021, including drug resistance and communicable diseases. Every year vector-borne diseases such as malaria cause the loss of more than 700,000 lives annually, predominantly in regions with tropical climates in low- and middle-income countries. Major vector-borne diseases account for 17% of the global burden of communicable diseases. Recent studies have shown that climate change has the potential to shift the regions in which disease-carrying mosquitoes breed, introducing new pathogens to previously unaffected areas. For example, the spread of malaria, caused by a parasite that spreads to humans and other animals through the bites of infected female mosquitoes, increases in temperatures of around 25ºC. Coupled with the increasing prevalence of drug-resistant superbugs and insecticide resistance, it is clear that new tools are needed to fight against vector-borne diseases. “Efforts to end infectious diseases will only succeed if we have the tools to treat and prevent them,” said Dr Timothy Wells, MMV’s Chief Scientific Officer. Collection of compounds for malaria, neglected and zoonotic diseases, and more The collection features 240 compounds that can be used against drug-resistant malaria, neglected and zoonotic diseases, and other diseases at risk of drug resistance. This includes: 80 compounds with confirmed activity against drug-resistant malaria. 80 compounds for screening against neglected and zoonotic diseases, and diseases at risk of drug resistance. 80 compounds that have been tested for activity against various vector species. Priority Box’s ‘open approach’ emphasizes international collaboration The Global Health Priority Box’s builds on the reaction of the scientific community to the COVID-19 pandemic, which demonstrated that international collaboration accelerates the development of new tools, diagnostics and vaccines. Its open approach invites scientists to make screening results publicly available and to publish findings in an open access journal within two years following data generation. Such an approach allows for researchers around the world to build on one another’s work, saving time and resources. “Open innovation is one of the keys to unlocking drug discovery because it allows us to tap into existing knowledge and expertise and build on it collaboratively,” said Wells. Dr Nick Hamon, CEO of IVCC, noted the need for innovation in vector control due to the increased prevalence of insecticide resistance, “which is undermining the efficacy of bed nets and indoor residual sprays, the cornerstone of malaria prevention since the turn of the century.” “Open access to new chemistry will encourage greater collaboration across the scientific community, bringing new innovators into public health and potentially more rapid development of new vector control solutions,” he said. Image Credits: Sanofi Pasteur/Flickr. WHO Recommends Two Monoclonal Antibodies for Ebola Treatment; Calls to Expand Access in Developing Countries 19/08/2022 John Heilprin A health worker dresses in protective clothing to enter the treatment unit for a suspected Ebola case at western Uganda’s Bwera General Hospital in August 2019 – during the 2018-2020 Ebola outbreak in the neighboring Democratic Republic of Congo. In its first guidelines ever for Ebola treatment, the World Health Organization (WHO) advises using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease, including older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth,” WHO says. In its launch of the recommendations, WHO also called on the global community “to increase access to these lifesaving medicines”. As relatively new therapies, monoclonal antibodies have been difficult and expensive to access in low- and middle-income countries, with 80% of their sales occuring in the US, Canada and Europe. In 2020, a consortium of research organizations, led by Wellcome Trust issued a global call to action to expand access. Yes to Ansuvimab and Inmazeb, No to ZMapp and Remdesivir Patients should receive recommended neutralizing monoclonal antibodies as soon as possible after laboratory confirmation of diagnosis, according to WHO. Its new 44-page guidelines for Ebola treatment also makes a “conditional recommendation against” the use of ZMapp and remdesivir for patients with the Ebola virus. ZMapp, a drug cocktail of antibodies developed from the tobacco plant, was the first drug to be used on an experimental basis against the Ebola virus. Initially it showed promise with rhesus monkeys, but was not fully tested on humans. During the 2014-2016 Ebola epidemic in West Africa, however, the US Food and Drug Administration (FDA) approved ZMapp’s experimental use on patients. That epidemic, the continent’s largest ever, killed more than 11,000 people out of the 28,000 people who became ill with the virus. Subsequently, ZMapp, remdesivir as well as mAb114 and REGN-EB3 were all tested against one another in a randomized controlled trial in the Democratic Republic of Congo, running in parallel to the Ebola epidemic that wracked the eastern region of the country between 2018-2020. In August 2019, however, an independent monitoring board recommended early termination of the DRC therapeutics trial due to the favorable results demonstrated by the latter two drug candidates. The board recommended that all patients be randomized to receive either REGN-EB3 or mAb114 in an extension phase. The study’s preliminary results among 499 participants showed people who got REGN-EB3 or mAb114 had a greater chance of survival than those who received ZMapp or remdesivir. Remdesivir was originally developed to treat hepatitis C before it was investigated for treating the Ebola and Marburg viruses, and then as a post-infection treatment for COVID‑19. It eventually won US and European Medicines Agency approval as a COVID-19 treatment. However, in November 2020, WHO recommended against Remdesivir use for COVID, saying there was “no evidence” it improved patient outcomes. Access remains a problem for ebola treatment In its recommendations, WHO called for greater efforts to ensure that that the drugs are “where patients need them the most: where there is an active Ebola outbreak, or where the threat of outbreaks is high or very likely.” To assist with that goal, WHO offered to support “countries, manufacturers and partners” to step up national and global efforts to increase affordability of the biotherapeutic products. “Access to these therapeutics is challenging and pricing and future supply remain unknown, especially in resource-poor areas,” WHO says in its 44-page guidelines. “Without concerted effort, access will remain limited, and it is therefore possible that this strong recommendation could exacerbate health inequity,” it says. “Therefore, given the demonstrated benefits for patients, these recommendations should act as a stimulus to engage all possible mechanisms to improve global access to these treatments.” Both Inmazeb and Ebanga were developed with significant US government support The development of both Inmazeb and Ebanga was heavily supported by the US government and other public funders. Inmazeb, which also was the first FDA-approved treatment for Ebola, is produced by the US-based Regeneron Pharmaceuticals. It was developed in response to the 2018 Ebola outbreak in the DRC with supprot from the US Biomedical Advanced Research and Development Authority (BARDA). Regeneron announced in 2020, the company will “continue to provide Inmazeb for free in response to outbreaks in the DRC through the MEURI protocol for compassionate use,” in colaboration with the WHO, the US FDA and with continuing support from BARDA. “Regeneron is actively working with nongovernmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries,” the company declared at that time. The MEURI protocol is a WHO-approved ethical framework for the use of investigational agents. Regeneron gained fame in the first year of the COVID pandemic when former President Donald Trump was treated with another antibody cocktail that it had developed against COVID, (REGEN-COV- a combination of casirivimab and imdevimab) . The cocktail was later recommended by WHO for COVID treatment. As for Ebanga, it was initially developed by the Vaccine Research Center of the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), and then licensed in 2018 by the US biotech firm, Ridgeback Biotherapeutics for further development and ultimately FDA aprpoval. “Ebanga is currently available to patients, and Ridgeback Biotherapeutics provides and distributes the treatment to patients free of charge in Ebola-stricken countries,” the company states on its website. WHO publishes invitation to drug manufacturers to share drugs for evaluation WHO says it has now published the first invitation to manufacturers of therapeutics against Ebola virus disease to share their drugs for evaluation by the WHO Prequalification Unit, a crucial step to enabling bulk procurement of new drugs by global health agencies, for communities and countries affected by Ebola. “We have seen incredible advances in both the quality and safety of clinical care during Ebola outbreaks,” said Dr Janet Diaz, lead of the clinical management unit in WHO’s Health Emergencies program. “Doing the basics well, including early diagnosis, providing optimized supportive care with the evaluation of new therapeutics under clinical trials, has transformed what is possible during Ebola outbreaks,” she said. “This is what has led to development of a new standard of care for patients. However, timely access to these lifesaving interventions has to be a priority.” WHO also says there is a need for more research and evaluation of clinical interventions because of the large number of “uncertainties” that remain including with supportive care, with our understanding and characterization of the Ebola virus disease and its longer-term consequences, with the continued inclusion of vulnerable populations such as pregnant women, newborns, children and older people in future research. Back to the DRC for More Research, Studies on Ebola treatment The clinical trials used to shape WHO’S guidelines for Ebola treatment were conducted during the Ebola outbreaks that have raged in central and west Africa over the past six years; the largest trial was conducted in the Democratic Republic of the Congo (DRC) which saw a major outbreak in 2018-2020, as well as small outbreaks since then. Ebola is a severe and too often fatal illness, and previous outbreaks and responses showed the importance of early diagnosis and treatment with optimized supportive care that includes fluid and electrolyte repletion and treatment of symptoms. “This therapeutic guide is a critical tool to fight Ebola,” said Dr Richard Kojan, co-chair of the Guideline Development Group of experts selected by WHO and President of ALIMA, The Alliance for International Medical Action. “It will help reassure the communities, health care workers and patients, that this life-threatening disease can be treated thanks to effective drugs,” said Kojan. “From now on, people infected with the Ebola virus will have a greater chance of recovering if they seek care as early as possible,” he said. “As with other infectious diseases, timeliness is key, and people should not hesitate to consult health workers as quickly as possible to ensure they receive the best care possible.” The DRC has now recorded 14 Ebola outbreaks since 1976, including six since 2018. The most recent outbreak, which began in April, was declared to be over by DRC and WHO authorities last month — with fewer cases and deaths (five) than previous episodes due to a swift response including vaccinations. Vaccinations were launched less than a week after the outbreak was declared, using an ultra-cold chain freezer in Mbandaka so vaccine doses could be stored locally and safely, and delivered effectively. That enabled 2,104 people to be vaccinated, including 1,307 frontline workers and 302 contacts. In the previous outbreak in Equateur Province from June to November 2020, 130 people were infected and 55 died. Africa’s battles with Ebola and other deadly diseases also helped prepare its health systems to deal with COVID-19. When SARS-CoV2 virus landed on the continent, the African Centres for Disease Control (CDC) reinforced its regional coordinating centers, enhanced lab capacity and unified surveillance networks. An Additional Tool for Ebola treatment Along With Clinical Care Guidance The new Ebola treatment guidelines are meant to complement clinical care guidance that outlines the optimized supportive care Ebola patients should receive including factors such as relevant tests, pain management, nutrition and co-infections. But the recommendations only apply to the Ebola virus disease caused by Ebola virus (EBOV; Zaire ebolavirus). “Advances in supportive care and therapeutics over the past decade have revolutionized the treatment of Ebola. Ebola virus disease used to be perceived as a near certain killer. However, that is no longer the case,” said Dr Robert Fowler of the University of Toronto and co-chair of the Guideline Development Group of experts selected by WHO. “Provision of best supportive medical care to patients, combined with monoclonal antibody treatment — MAb114 or REGN-EB3 — now leads to recovery for the vast majority of people,” he said. Image Credits: Photo: Anna Dubuis / DFID, WHO Therapeutics for Ebola virus disease. 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.
Monkeypox Vaccine: 62% of Recipients Experience No Side Effects, Says New Survey 22/08/2022 Maayan Hoffman Jynneos Monkeypox Vaccine A first-of-its-kind survey examining the side effects of the monkeypox vaccine in Israel found that the majority of recipients had no general symptoms. “Most of the side effects reported by the vaccinated are local and mild, which in most cases pass within one to three days,” said Miri Mizrahi Reuveni, Deputy CEO and Head of the Health Division at Maccabi Healthcare Services, which conducted the survey. Maccabi is one of Israel’s four major public health funds. This is some of the first data to be systematically reported on side effects of the vaccine and uptake since the outbreak began, however, the data does not reflect on the vaccine’s efficacy which will take more time to assess. Specifically, some 62% of 155 vaccine recipients reported a return to routine without any general symptoms, Maccabi reported on Monday. The other 38% experienced side effects. Among those who experienced side effects, most fell into broad categories: 27% reported weakness and fatigue; 11% complained of muscle pain; 9% had headaches; 6% suffered from diarrhea; 5% got nausea; 4% had less appetite and swelling of the lymph nodes; 3% felt chills and joint pain; 1% got a skin rash; and another 1% felt eye irritation. A majority of recipients, or 74%, experienced pain at the site of injection, including stiffness (22%), localized swelling (7%) and itching (6%). In most cases, those who experienced side effects said they lasted more than 24 hours. But 22% of recipients who had symptoms said they persist today. Only 3 percent reported that their symptoms passed in less than 24 hours. About 10% said they lasted one day; 39% said they ended within two to three days; and 19% complained of symptoms that took four to six days to resolve. Eight-five percent of respondents said they had no hesitation about getting the jab. The health fund also asked people why they decided to get vaccinated. The most common responses were a desire to protect themselves and those around them. More than a third said they also were afraid of becoming isolated. More than people who belong to the HMO have taken the vaccine already, according to Reuveni. The survey began when the country started distributing the vaccine at the start of August. Respondents were asked questions after they got the shot and seven days later. As of the end of last week, the Israeli Health Ministry reported 197 cases of monkeypox in the country, all of them involving men. Ministry officials told Health Policy Watch on Monday that so far more than 2,300 Israelis have been vaccinated against the virus. The country recently expanded its vaccination criteria to allow more people to get the shot. Israel ordered 10,000 vaccine doses, of which a little more than half have arrived. Some 4,400 vaccine doses are expected to arrive at the beginning of September, ministry officials said. The international monkeypox outbreak began on May 4 when a first case outside of historically endemic African countries was discovered in London. Since then, it has spread across the world, according to the World Health Organization (WHO), with more than 35,000 cases of monkeypox reported from 92 countries and territories accompanied by 12 deaths. WHO Monkeypox Dashboard as of 22 August 2022 Image Credits: Star919News/Twitter , WHO. Open Access 240 Compound Collection Launched in Fight Against Infectious and Mosquito-Borne Illnesses for World Mosquito Day 22/08/2022 Raisa Santos Aedes aegypti mosquito can spread Zika fever, dengue, and other diseases. To mark World Mosquito Day, 20 August, the Global Health Priority Box has been launched to provide free access to 240 compounds to stimulate research into new drugs and insecticides. The initiative, launched by the Medicines for Malaria Venture (MMV) and the Innovative Vector Control Consortium (IVCC), provides scientists with starting points to advance the development of tools that can tackle several priorities set out by the WHO in late 2021, including drug resistance and communicable diseases. Every year vector-borne diseases such as malaria cause the loss of more than 700,000 lives annually, predominantly in regions with tropical climates in low- and middle-income countries. Major vector-borne diseases account for 17% of the global burden of communicable diseases. Recent studies have shown that climate change has the potential to shift the regions in which disease-carrying mosquitoes breed, introducing new pathogens to previously unaffected areas. For example, the spread of malaria, caused by a parasite that spreads to humans and other animals through the bites of infected female mosquitoes, increases in temperatures of around 25ºC. Coupled with the increasing prevalence of drug-resistant superbugs and insecticide resistance, it is clear that new tools are needed to fight against vector-borne diseases. “Efforts to end infectious diseases will only succeed if we have the tools to treat and prevent them,” said Dr Timothy Wells, MMV’s Chief Scientific Officer. Collection of compounds for malaria, neglected and zoonotic diseases, and more The collection features 240 compounds that can be used against drug-resistant malaria, neglected and zoonotic diseases, and other diseases at risk of drug resistance. This includes: 80 compounds with confirmed activity against drug-resistant malaria. 80 compounds for screening against neglected and zoonotic diseases, and diseases at risk of drug resistance. 80 compounds that have been tested for activity against various vector species. Priority Box’s ‘open approach’ emphasizes international collaboration The Global Health Priority Box’s builds on the reaction of the scientific community to the COVID-19 pandemic, which demonstrated that international collaboration accelerates the development of new tools, diagnostics and vaccines. Its open approach invites scientists to make screening results publicly available and to publish findings in an open access journal within two years following data generation. Such an approach allows for researchers around the world to build on one another’s work, saving time and resources. “Open innovation is one of the keys to unlocking drug discovery because it allows us to tap into existing knowledge and expertise and build on it collaboratively,” said Wells. Dr Nick Hamon, CEO of IVCC, noted the need for innovation in vector control due to the increased prevalence of insecticide resistance, “which is undermining the efficacy of bed nets and indoor residual sprays, the cornerstone of malaria prevention since the turn of the century.” “Open access to new chemistry will encourage greater collaboration across the scientific community, bringing new innovators into public health and potentially more rapid development of new vector control solutions,” he said. Image Credits: Sanofi Pasteur/Flickr. WHO Recommends Two Monoclonal Antibodies for Ebola Treatment; Calls to Expand Access in Developing Countries 19/08/2022 John Heilprin A health worker dresses in protective clothing to enter the treatment unit for a suspected Ebola case at western Uganda’s Bwera General Hospital in August 2019 – during the 2018-2020 Ebola outbreak in the neighboring Democratic Republic of Congo. In its first guidelines ever for Ebola treatment, the World Health Organization (WHO) advises using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease, including older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth,” WHO says. In its launch of the recommendations, WHO also called on the global community “to increase access to these lifesaving medicines”. As relatively new therapies, monoclonal antibodies have been difficult and expensive to access in low- and middle-income countries, with 80% of their sales occuring in the US, Canada and Europe. In 2020, a consortium of research organizations, led by Wellcome Trust issued a global call to action to expand access. Yes to Ansuvimab and Inmazeb, No to ZMapp and Remdesivir Patients should receive recommended neutralizing monoclonal antibodies as soon as possible after laboratory confirmation of diagnosis, according to WHO. Its new 44-page guidelines for Ebola treatment also makes a “conditional recommendation against” the use of ZMapp and remdesivir for patients with the Ebola virus. ZMapp, a drug cocktail of antibodies developed from the tobacco plant, was the first drug to be used on an experimental basis against the Ebola virus. Initially it showed promise with rhesus monkeys, but was not fully tested on humans. During the 2014-2016 Ebola epidemic in West Africa, however, the US Food and Drug Administration (FDA) approved ZMapp’s experimental use on patients. That epidemic, the continent’s largest ever, killed more than 11,000 people out of the 28,000 people who became ill with the virus. Subsequently, ZMapp, remdesivir as well as mAb114 and REGN-EB3 were all tested against one another in a randomized controlled trial in the Democratic Republic of Congo, running in parallel to the Ebola epidemic that wracked the eastern region of the country between 2018-2020. In August 2019, however, an independent monitoring board recommended early termination of the DRC therapeutics trial due to the favorable results demonstrated by the latter two drug candidates. The board recommended that all patients be randomized to receive either REGN-EB3 or mAb114 in an extension phase. The study’s preliminary results among 499 participants showed people who got REGN-EB3 or mAb114 had a greater chance of survival than those who received ZMapp or remdesivir. Remdesivir was originally developed to treat hepatitis C before it was investigated for treating the Ebola and Marburg viruses, and then as a post-infection treatment for COVID‑19. It eventually won US and European Medicines Agency approval as a COVID-19 treatment. However, in November 2020, WHO recommended against Remdesivir use for COVID, saying there was “no evidence” it improved patient outcomes. Access remains a problem for ebola treatment In its recommendations, WHO called for greater efforts to ensure that that the drugs are “where patients need them the most: where there is an active Ebola outbreak, or where the threat of outbreaks is high or very likely.” To assist with that goal, WHO offered to support “countries, manufacturers and partners” to step up national and global efforts to increase affordability of the biotherapeutic products. “Access to these therapeutics is challenging and pricing and future supply remain unknown, especially in resource-poor areas,” WHO says in its 44-page guidelines. “Without concerted effort, access will remain limited, and it is therefore possible that this strong recommendation could exacerbate health inequity,” it says. “Therefore, given the demonstrated benefits for patients, these recommendations should act as a stimulus to engage all possible mechanisms to improve global access to these treatments.” Both Inmazeb and Ebanga were developed with significant US government support The development of both Inmazeb and Ebanga was heavily supported by the US government and other public funders. Inmazeb, which also was the first FDA-approved treatment for Ebola, is produced by the US-based Regeneron Pharmaceuticals. It was developed in response to the 2018 Ebola outbreak in the DRC with supprot from the US Biomedical Advanced Research and Development Authority (BARDA). Regeneron announced in 2020, the company will “continue to provide Inmazeb for free in response to outbreaks in the DRC through the MEURI protocol for compassionate use,” in colaboration with the WHO, the US FDA and with continuing support from BARDA. “Regeneron is actively working with nongovernmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries,” the company declared at that time. The MEURI protocol is a WHO-approved ethical framework for the use of investigational agents. Regeneron gained fame in the first year of the COVID pandemic when former President Donald Trump was treated with another antibody cocktail that it had developed against COVID, (REGEN-COV- a combination of casirivimab and imdevimab) . The cocktail was later recommended by WHO for COVID treatment. As for Ebanga, it was initially developed by the Vaccine Research Center of the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), and then licensed in 2018 by the US biotech firm, Ridgeback Biotherapeutics for further development and ultimately FDA aprpoval. “Ebanga is currently available to patients, and Ridgeback Biotherapeutics provides and distributes the treatment to patients free of charge in Ebola-stricken countries,” the company states on its website. WHO publishes invitation to drug manufacturers to share drugs for evaluation WHO says it has now published the first invitation to manufacturers of therapeutics against Ebola virus disease to share their drugs for evaluation by the WHO Prequalification Unit, a crucial step to enabling bulk procurement of new drugs by global health agencies, for communities and countries affected by Ebola. “We have seen incredible advances in both the quality and safety of clinical care during Ebola outbreaks,” said Dr Janet Diaz, lead of the clinical management unit in WHO’s Health Emergencies program. “Doing the basics well, including early diagnosis, providing optimized supportive care with the evaluation of new therapeutics under clinical trials, has transformed what is possible during Ebola outbreaks,” she said. “This is what has led to development of a new standard of care for patients. However, timely access to these lifesaving interventions has to be a priority.” WHO also says there is a need for more research and evaluation of clinical interventions because of the large number of “uncertainties” that remain including with supportive care, with our understanding and characterization of the Ebola virus disease and its longer-term consequences, with the continued inclusion of vulnerable populations such as pregnant women, newborns, children and older people in future research. Back to the DRC for More Research, Studies on Ebola treatment The clinical trials used to shape WHO’S guidelines for Ebola treatment were conducted during the Ebola outbreaks that have raged in central and west Africa over the past six years; the largest trial was conducted in the Democratic Republic of the Congo (DRC) which saw a major outbreak in 2018-2020, as well as small outbreaks since then. Ebola is a severe and too often fatal illness, and previous outbreaks and responses showed the importance of early diagnosis and treatment with optimized supportive care that includes fluid and electrolyte repletion and treatment of symptoms. “This therapeutic guide is a critical tool to fight Ebola,” said Dr Richard Kojan, co-chair of the Guideline Development Group of experts selected by WHO and President of ALIMA, The Alliance for International Medical Action. “It will help reassure the communities, health care workers and patients, that this life-threatening disease can be treated thanks to effective drugs,” said Kojan. “From now on, people infected with the Ebola virus will have a greater chance of recovering if they seek care as early as possible,” he said. “As with other infectious diseases, timeliness is key, and people should not hesitate to consult health workers as quickly as possible to ensure they receive the best care possible.” The DRC has now recorded 14 Ebola outbreaks since 1976, including six since 2018. The most recent outbreak, which began in April, was declared to be over by DRC and WHO authorities last month — with fewer cases and deaths (five) than previous episodes due to a swift response including vaccinations. Vaccinations were launched less than a week after the outbreak was declared, using an ultra-cold chain freezer in Mbandaka so vaccine doses could be stored locally and safely, and delivered effectively. That enabled 2,104 people to be vaccinated, including 1,307 frontline workers and 302 contacts. In the previous outbreak in Equateur Province from June to November 2020, 130 people were infected and 55 died. Africa’s battles with Ebola and other deadly diseases also helped prepare its health systems to deal with COVID-19. When SARS-CoV2 virus landed on the continent, the African Centres for Disease Control (CDC) reinforced its regional coordinating centers, enhanced lab capacity and unified surveillance networks. An Additional Tool for Ebola treatment Along With Clinical Care Guidance The new Ebola treatment guidelines are meant to complement clinical care guidance that outlines the optimized supportive care Ebola patients should receive including factors such as relevant tests, pain management, nutrition and co-infections. But the recommendations only apply to the Ebola virus disease caused by Ebola virus (EBOV; Zaire ebolavirus). “Advances in supportive care and therapeutics over the past decade have revolutionized the treatment of Ebola. Ebola virus disease used to be perceived as a near certain killer. However, that is no longer the case,” said Dr Robert Fowler of the University of Toronto and co-chair of the Guideline Development Group of experts selected by WHO. “Provision of best supportive medical care to patients, combined with monoclonal antibody treatment — MAb114 or REGN-EB3 — now leads to recovery for the vast majority of people,” he said. Image Credits: Photo: Anna Dubuis / DFID, WHO Therapeutics for Ebola virus disease. 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.
Open Access 240 Compound Collection Launched in Fight Against Infectious and Mosquito-Borne Illnesses for World Mosquito Day 22/08/2022 Raisa Santos Aedes aegypti mosquito can spread Zika fever, dengue, and other diseases. To mark World Mosquito Day, 20 August, the Global Health Priority Box has been launched to provide free access to 240 compounds to stimulate research into new drugs and insecticides. The initiative, launched by the Medicines for Malaria Venture (MMV) and the Innovative Vector Control Consortium (IVCC), provides scientists with starting points to advance the development of tools that can tackle several priorities set out by the WHO in late 2021, including drug resistance and communicable diseases. Every year vector-borne diseases such as malaria cause the loss of more than 700,000 lives annually, predominantly in regions with tropical climates in low- and middle-income countries. Major vector-borne diseases account for 17% of the global burden of communicable diseases. Recent studies have shown that climate change has the potential to shift the regions in which disease-carrying mosquitoes breed, introducing new pathogens to previously unaffected areas. For example, the spread of malaria, caused by a parasite that spreads to humans and other animals through the bites of infected female mosquitoes, increases in temperatures of around 25ºC. Coupled with the increasing prevalence of drug-resistant superbugs and insecticide resistance, it is clear that new tools are needed to fight against vector-borne diseases. “Efforts to end infectious diseases will only succeed if we have the tools to treat and prevent them,” said Dr Timothy Wells, MMV’s Chief Scientific Officer. Collection of compounds for malaria, neglected and zoonotic diseases, and more The collection features 240 compounds that can be used against drug-resistant malaria, neglected and zoonotic diseases, and other diseases at risk of drug resistance. This includes: 80 compounds with confirmed activity against drug-resistant malaria. 80 compounds for screening against neglected and zoonotic diseases, and diseases at risk of drug resistance. 80 compounds that have been tested for activity against various vector species. Priority Box’s ‘open approach’ emphasizes international collaboration The Global Health Priority Box’s builds on the reaction of the scientific community to the COVID-19 pandemic, which demonstrated that international collaboration accelerates the development of new tools, diagnostics and vaccines. Its open approach invites scientists to make screening results publicly available and to publish findings in an open access journal within two years following data generation. Such an approach allows for researchers around the world to build on one another’s work, saving time and resources. “Open innovation is one of the keys to unlocking drug discovery because it allows us to tap into existing knowledge and expertise and build on it collaboratively,” said Wells. Dr Nick Hamon, CEO of IVCC, noted the need for innovation in vector control due to the increased prevalence of insecticide resistance, “which is undermining the efficacy of bed nets and indoor residual sprays, the cornerstone of malaria prevention since the turn of the century.” “Open access to new chemistry will encourage greater collaboration across the scientific community, bringing new innovators into public health and potentially more rapid development of new vector control solutions,” he said. Image Credits: Sanofi Pasteur/Flickr. WHO Recommends Two Monoclonal Antibodies for Ebola Treatment; Calls to Expand Access in Developing Countries 19/08/2022 John Heilprin A health worker dresses in protective clothing to enter the treatment unit for a suspected Ebola case at western Uganda’s Bwera General Hospital in August 2019 – during the 2018-2020 Ebola outbreak in the neighboring Democratic Republic of Congo. In its first guidelines ever for Ebola treatment, the World Health Organization (WHO) advises using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease, including older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth,” WHO says. In its launch of the recommendations, WHO also called on the global community “to increase access to these lifesaving medicines”. As relatively new therapies, monoclonal antibodies have been difficult and expensive to access in low- and middle-income countries, with 80% of their sales occuring in the US, Canada and Europe. In 2020, a consortium of research organizations, led by Wellcome Trust issued a global call to action to expand access. Yes to Ansuvimab and Inmazeb, No to ZMapp and Remdesivir Patients should receive recommended neutralizing monoclonal antibodies as soon as possible after laboratory confirmation of diagnosis, according to WHO. Its new 44-page guidelines for Ebola treatment also makes a “conditional recommendation against” the use of ZMapp and remdesivir for patients with the Ebola virus. ZMapp, a drug cocktail of antibodies developed from the tobacco plant, was the first drug to be used on an experimental basis against the Ebola virus. Initially it showed promise with rhesus monkeys, but was not fully tested on humans. During the 2014-2016 Ebola epidemic in West Africa, however, the US Food and Drug Administration (FDA) approved ZMapp’s experimental use on patients. That epidemic, the continent’s largest ever, killed more than 11,000 people out of the 28,000 people who became ill with the virus. Subsequently, ZMapp, remdesivir as well as mAb114 and REGN-EB3 were all tested against one another in a randomized controlled trial in the Democratic Republic of Congo, running in parallel to the Ebola epidemic that wracked the eastern region of the country between 2018-2020. In August 2019, however, an independent monitoring board recommended early termination of the DRC therapeutics trial due to the favorable results demonstrated by the latter two drug candidates. The board recommended that all patients be randomized to receive either REGN-EB3 or mAb114 in an extension phase. The study’s preliminary results among 499 participants showed people who got REGN-EB3 or mAb114 had a greater chance of survival than those who received ZMapp or remdesivir. Remdesivir was originally developed to treat hepatitis C before it was investigated for treating the Ebola and Marburg viruses, and then as a post-infection treatment for COVID‑19. It eventually won US and European Medicines Agency approval as a COVID-19 treatment. However, in November 2020, WHO recommended against Remdesivir use for COVID, saying there was “no evidence” it improved patient outcomes. Access remains a problem for ebola treatment In its recommendations, WHO called for greater efforts to ensure that that the drugs are “where patients need them the most: where there is an active Ebola outbreak, or where the threat of outbreaks is high or very likely.” To assist with that goal, WHO offered to support “countries, manufacturers and partners” to step up national and global efforts to increase affordability of the biotherapeutic products. “Access to these therapeutics is challenging and pricing and future supply remain unknown, especially in resource-poor areas,” WHO says in its 44-page guidelines. “Without concerted effort, access will remain limited, and it is therefore possible that this strong recommendation could exacerbate health inequity,” it says. “Therefore, given the demonstrated benefits for patients, these recommendations should act as a stimulus to engage all possible mechanisms to improve global access to these treatments.” Both Inmazeb and Ebanga were developed with significant US government support The development of both Inmazeb and Ebanga was heavily supported by the US government and other public funders. Inmazeb, which also was the first FDA-approved treatment for Ebola, is produced by the US-based Regeneron Pharmaceuticals. It was developed in response to the 2018 Ebola outbreak in the DRC with supprot from the US Biomedical Advanced Research and Development Authority (BARDA). Regeneron announced in 2020, the company will “continue to provide Inmazeb for free in response to outbreaks in the DRC through the MEURI protocol for compassionate use,” in colaboration with the WHO, the US FDA and with continuing support from BARDA. “Regeneron is actively working with nongovernmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries,” the company declared at that time. The MEURI protocol is a WHO-approved ethical framework for the use of investigational agents. Regeneron gained fame in the first year of the COVID pandemic when former President Donald Trump was treated with another antibody cocktail that it had developed against COVID, (REGEN-COV- a combination of casirivimab and imdevimab) . The cocktail was later recommended by WHO for COVID treatment. As for Ebanga, it was initially developed by the Vaccine Research Center of the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), and then licensed in 2018 by the US biotech firm, Ridgeback Biotherapeutics for further development and ultimately FDA aprpoval. “Ebanga is currently available to patients, and Ridgeback Biotherapeutics provides and distributes the treatment to patients free of charge in Ebola-stricken countries,” the company states on its website. WHO publishes invitation to drug manufacturers to share drugs for evaluation WHO says it has now published the first invitation to manufacturers of therapeutics against Ebola virus disease to share their drugs for evaluation by the WHO Prequalification Unit, a crucial step to enabling bulk procurement of new drugs by global health agencies, for communities and countries affected by Ebola. “We have seen incredible advances in both the quality and safety of clinical care during Ebola outbreaks,” said Dr Janet Diaz, lead of the clinical management unit in WHO’s Health Emergencies program. “Doing the basics well, including early diagnosis, providing optimized supportive care with the evaluation of new therapeutics under clinical trials, has transformed what is possible during Ebola outbreaks,” she said. “This is what has led to development of a new standard of care for patients. However, timely access to these lifesaving interventions has to be a priority.” WHO also says there is a need for more research and evaluation of clinical interventions because of the large number of “uncertainties” that remain including with supportive care, with our understanding and characterization of the Ebola virus disease and its longer-term consequences, with the continued inclusion of vulnerable populations such as pregnant women, newborns, children and older people in future research. Back to the DRC for More Research, Studies on Ebola treatment The clinical trials used to shape WHO’S guidelines for Ebola treatment were conducted during the Ebola outbreaks that have raged in central and west Africa over the past six years; the largest trial was conducted in the Democratic Republic of the Congo (DRC) which saw a major outbreak in 2018-2020, as well as small outbreaks since then. Ebola is a severe and too often fatal illness, and previous outbreaks and responses showed the importance of early diagnosis and treatment with optimized supportive care that includes fluid and electrolyte repletion and treatment of symptoms. “This therapeutic guide is a critical tool to fight Ebola,” said Dr Richard Kojan, co-chair of the Guideline Development Group of experts selected by WHO and President of ALIMA, The Alliance for International Medical Action. “It will help reassure the communities, health care workers and patients, that this life-threatening disease can be treated thanks to effective drugs,” said Kojan. “From now on, people infected with the Ebola virus will have a greater chance of recovering if they seek care as early as possible,” he said. “As with other infectious diseases, timeliness is key, and people should not hesitate to consult health workers as quickly as possible to ensure they receive the best care possible.” The DRC has now recorded 14 Ebola outbreaks since 1976, including six since 2018. The most recent outbreak, which began in April, was declared to be over by DRC and WHO authorities last month — with fewer cases and deaths (five) than previous episodes due to a swift response including vaccinations. Vaccinations were launched less than a week after the outbreak was declared, using an ultra-cold chain freezer in Mbandaka so vaccine doses could be stored locally and safely, and delivered effectively. That enabled 2,104 people to be vaccinated, including 1,307 frontline workers and 302 contacts. In the previous outbreak in Equateur Province from June to November 2020, 130 people were infected and 55 died. Africa’s battles with Ebola and other deadly diseases also helped prepare its health systems to deal with COVID-19. When SARS-CoV2 virus landed on the continent, the African Centres for Disease Control (CDC) reinforced its regional coordinating centers, enhanced lab capacity and unified surveillance networks. An Additional Tool for Ebola treatment Along With Clinical Care Guidance The new Ebola treatment guidelines are meant to complement clinical care guidance that outlines the optimized supportive care Ebola patients should receive including factors such as relevant tests, pain management, nutrition and co-infections. But the recommendations only apply to the Ebola virus disease caused by Ebola virus (EBOV; Zaire ebolavirus). “Advances in supportive care and therapeutics over the past decade have revolutionized the treatment of Ebola. Ebola virus disease used to be perceived as a near certain killer. However, that is no longer the case,” said Dr Robert Fowler of the University of Toronto and co-chair of the Guideline Development Group of experts selected by WHO. “Provision of best supportive medical care to patients, combined with monoclonal antibody treatment — MAb114 or REGN-EB3 — now leads to recovery for the vast majority of people,” he said. 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WHO Recommends Two Monoclonal Antibodies for Ebola Treatment; Calls to Expand Access in Developing Countries 19/08/2022 John Heilprin A health worker dresses in protective clothing to enter the treatment unit for a suspected Ebola case at western Uganda’s Bwera General Hospital in August 2019 – during the 2018-2020 Ebola outbreak in the neighboring Democratic Republic of Congo. In its first guidelines ever for Ebola treatment, the World Health Organization (WHO) advises using two monoclonal antibodies — mAb114 (Ansuvimab®, also known as Ebanga®) and REGN-EB3 (Inmazeb®) — that were first approved by the US Food and Drug Administration for use against the Zaire ebolavirus species in 2020. WHO says its “strong recommendations” for the two monoclonal antibody treatments that were released on Friday are based on a systematic review and meta-analysis of randomized clinical trials examining potential therapeutics for the deadly disease. The two therapies demonstrated “clear benefits and therefore can be used for all patients confirmed positive for Ebola virus disease, including older people, pregnant and breastfeeding women, children and newborns born to mothers with confirmed Ebola within the first seven days after birth,” WHO says. In its launch of the recommendations, WHO also called on the global community “to increase access to these lifesaving medicines”. As relatively new therapies, monoclonal antibodies have been difficult and expensive to access in low- and middle-income countries, with 80% of their sales occuring in the US, Canada and Europe. In 2020, a consortium of research organizations, led by Wellcome Trust issued a global call to action to expand access. Yes to Ansuvimab and Inmazeb, No to ZMapp and Remdesivir Patients should receive recommended neutralizing monoclonal antibodies as soon as possible after laboratory confirmation of diagnosis, according to WHO. Its new 44-page guidelines for Ebola treatment also makes a “conditional recommendation against” the use of ZMapp and remdesivir for patients with the Ebola virus. ZMapp, a drug cocktail of antibodies developed from the tobacco plant, was the first drug to be used on an experimental basis against the Ebola virus. Initially it showed promise with rhesus monkeys, but was not fully tested on humans. During the 2014-2016 Ebola epidemic in West Africa, however, the US Food and Drug Administration (FDA) approved ZMapp’s experimental use on patients. That epidemic, the continent’s largest ever, killed more than 11,000 people out of the 28,000 people who became ill with the virus. Subsequently, ZMapp, remdesivir as well as mAb114 and REGN-EB3 were all tested against one another in a randomized controlled trial in the Democratic Republic of Congo, running in parallel to the Ebola epidemic that wracked the eastern region of the country between 2018-2020. In August 2019, however, an independent monitoring board recommended early termination of the DRC therapeutics trial due to the favorable results demonstrated by the latter two drug candidates. The board recommended that all patients be randomized to receive either REGN-EB3 or mAb114 in an extension phase. The study’s preliminary results among 499 participants showed people who got REGN-EB3 or mAb114 had a greater chance of survival than those who received ZMapp or remdesivir. Remdesivir was originally developed to treat hepatitis C before it was investigated for treating the Ebola and Marburg viruses, and then as a post-infection treatment for COVID‑19. It eventually won US and European Medicines Agency approval as a COVID-19 treatment. However, in November 2020, WHO recommended against Remdesivir use for COVID, saying there was “no evidence” it improved patient outcomes. Access remains a problem for ebola treatment In its recommendations, WHO called for greater efforts to ensure that that the drugs are “where patients need them the most: where there is an active Ebola outbreak, or where the threat of outbreaks is high or very likely.” To assist with that goal, WHO offered to support “countries, manufacturers and partners” to step up national and global efforts to increase affordability of the biotherapeutic products. “Access to these therapeutics is challenging and pricing and future supply remain unknown, especially in resource-poor areas,” WHO says in its 44-page guidelines. “Without concerted effort, access will remain limited, and it is therefore possible that this strong recommendation could exacerbate health inequity,” it says. “Therefore, given the demonstrated benefits for patients, these recommendations should act as a stimulus to engage all possible mechanisms to improve global access to these treatments.” Both Inmazeb and Ebanga were developed with significant US government support The development of both Inmazeb and Ebanga was heavily supported by the US government and other public funders. Inmazeb, which also was the first FDA-approved treatment for Ebola, is produced by the US-based Regeneron Pharmaceuticals. It was developed in response to the 2018 Ebola outbreak in the DRC with supprot from the US Biomedical Advanced Research and Development Authority (BARDA). Regeneron announced in 2020, the company will “continue to provide Inmazeb for free in response to outbreaks in the DRC through the MEURI protocol for compassionate use,” in colaboration with the WHO, the US FDA and with continuing support from BARDA. “Regeneron is actively working with nongovernmental organizations and public health agencies to ensure continued access to Inmazeb in low- and middle-income countries,” the company declared at that time. The MEURI protocol is a WHO-approved ethical framework for the use of investigational agents. Regeneron gained fame in the first year of the COVID pandemic when former President Donald Trump was treated with another antibody cocktail that it had developed against COVID, (REGEN-COV- a combination of casirivimab and imdevimab) . The cocktail was later recommended by WHO for COVID treatment. As for Ebanga, it was initially developed by the Vaccine Research Center of the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), and then licensed in 2018 by the US biotech firm, Ridgeback Biotherapeutics for further development and ultimately FDA aprpoval. “Ebanga is currently available to patients, and Ridgeback Biotherapeutics provides and distributes the treatment to patients free of charge in Ebola-stricken countries,” the company states on its website. WHO publishes invitation to drug manufacturers to share drugs for evaluation WHO says it has now published the first invitation to manufacturers of therapeutics against Ebola virus disease to share their drugs for evaluation by the WHO Prequalification Unit, a crucial step to enabling bulk procurement of new drugs by global health agencies, for communities and countries affected by Ebola. “We have seen incredible advances in both the quality and safety of clinical care during Ebola outbreaks,” said Dr Janet Diaz, lead of the clinical management unit in WHO’s Health Emergencies program. “Doing the basics well, including early diagnosis, providing optimized supportive care with the evaluation of new therapeutics under clinical trials, has transformed what is possible during Ebola outbreaks,” she said. “This is what has led to development of a new standard of care for patients. However, timely access to these lifesaving interventions has to be a priority.” WHO also says there is a need for more research and evaluation of clinical interventions because of the large number of “uncertainties” that remain including with supportive care, with our understanding and characterization of the Ebola virus disease and its longer-term consequences, with the continued inclusion of vulnerable populations such as pregnant women, newborns, children and older people in future research. Back to the DRC for More Research, Studies on Ebola treatment The clinical trials used to shape WHO’S guidelines for Ebola treatment were conducted during the Ebola outbreaks that have raged in central and west Africa over the past six years; the largest trial was conducted in the Democratic Republic of the Congo (DRC) which saw a major outbreak in 2018-2020, as well as small outbreaks since then. Ebola is a severe and too often fatal illness, and previous outbreaks and responses showed the importance of early diagnosis and treatment with optimized supportive care that includes fluid and electrolyte repletion and treatment of symptoms. “This therapeutic guide is a critical tool to fight Ebola,” said Dr Richard Kojan, co-chair of the Guideline Development Group of experts selected by WHO and President of ALIMA, The Alliance for International Medical Action. “It will help reassure the communities, health care workers and patients, that this life-threatening disease can be treated thanks to effective drugs,” said Kojan. “From now on, people infected with the Ebola virus will have a greater chance of recovering if they seek care as early as possible,” he said. “As with other infectious diseases, timeliness is key, and people should not hesitate to consult health workers as quickly as possible to ensure they receive the best care possible.” The DRC has now recorded 14 Ebola outbreaks since 1976, including six since 2018. The most recent outbreak, which began in April, was declared to be over by DRC and WHO authorities last month — with fewer cases and deaths (five) than previous episodes due to a swift response including vaccinations. Vaccinations were launched less than a week after the outbreak was declared, using an ultra-cold chain freezer in Mbandaka so vaccine doses could be stored locally and safely, and delivered effectively. That enabled 2,104 people to be vaccinated, including 1,307 frontline workers and 302 contacts. In the previous outbreak in Equateur Province from June to November 2020, 130 people were infected and 55 died. Africa’s battles with Ebola and other deadly diseases also helped prepare its health systems to deal with COVID-19. When SARS-CoV2 virus landed on the continent, the African Centres for Disease Control (CDC) reinforced its regional coordinating centers, enhanced lab capacity and unified surveillance networks. An Additional Tool for Ebola treatment Along With Clinical Care Guidance The new Ebola treatment guidelines are meant to complement clinical care guidance that outlines the optimized supportive care Ebola patients should receive including factors such as relevant tests, pain management, nutrition and co-infections. But the recommendations only apply to the Ebola virus disease caused by Ebola virus (EBOV; Zaire ebolavirus). “Advances in supportive care and therapeutics over the past decade have revolutionized the treatment of Ebola. Ebola virus disease used to be perceived as a near certain killer. However, that is no longer the case,” said Dr Robert Fowler of the University of Toronto and co-chair of the Guideline Development Group of experts selected by WHO. “Provision of best supportive medical care to patients, combined with monoclonal antibody treatment — MAb114 or REGN-EB3 — now leads to recovery for the vast majority of people,” he said. Image Credits: Photo: Anna Dubuis / DFID, WHO Therapeutics for Ebola virus disease. Posts navigation Older postsNewer posts