Updated International Health Regulations More Important Than Pandemic Accord ? 28/04/2023 Kerry Cullinan Panellists Pedro Villarreal, Hélène de Pooter, Elisa Morgera, Daniel Warner and moderator Gian Luca Burci. As the current US Senate is unlikely to ratify a pandemic accord, it might make more sense for World Health Organization (WHO) member states to invest more effort in ensuring that the International Health Regulations (IHR) are adapted to respond to the next pandemic. So suggested Daniel Warner, Assistant Director for International Affairs at the Geneva Centre for the Democratic Control of Armed Forces (DCAF) at an event hosted by the Geneva Graduate Institute’s Global Health Centre. The IHR are the only global regulations to prevent the international spread of disease and contain certain binding obligations on member states. “Any treaty must be ratified by the United States Senate, and especially in today’s Senate, it would be difficult to get any multilateral treaty passed, as opposed to changes in the IHR that don’t need Senate approval and they are covered within the WHO constitution,” said Warner. IHR ‘more a priority’ He added that it would make sense for amendments to the IHR to be “more of a priority within the American position as opposed to some kind of treaty”. The US was one of the first countries to propose IHR amendments after weaknesses emerged during the COVID-19 pandemic and member states have proposed over 300 amendments. However, given that the IHR are the world’s only legally binding protection against the spread of diseases, it is essential that they are protected from “a political dimension and from political division”, warned fellow panellist Hélène de Pooter, a senior law lecturer at the University of Franche-Comté. Negotiations are taking place during “very difficult times for multilateralism”, De Pooter said. “The success of the ongoing negotiations at the WHO cannot be taken for granted, so the challenge for states’ representatives or diplomats is to keep health and health cooperation safe from the global disturbances that we are witnessing nowadays.” She added that it was “remarkable” that the IHR are not subjected to the traditional ratification process but enter into force automatically”. As regulations are “not political instruments” but “technical and procedural tools designed for the sake of efficient cooperation and coordination in the health sector”. As such, they should be “beneficial for all states, and for health cooperation, regardless of political party cleavages and specific national interests”. Universal, regardless of politics For this reason, she appealed for the IHR to be universal in appeal to ensure that they had wide appeal and support. The two were speaking on a panel on the concurrent negotiations on the pandemic accord and changes to the IHR, with drafts of both due to be presented at the 2024 World Health Assembly – and how to avoid a “collision” between the two processes. Pedro Villarreal, Senior Research Fellow at the German Institute for International and Security Affairs, said that a pandemic accord might take a long time to come into being as each member state would need to ratify it. Should a pandemic be declared soon after an accord had been passed by the World Health Assembly, only a few states might have ratified it. “What will happen in such a situation where a pandemic is declared and it turns out that obligations are applicable to some states but not others?” Villarreal asked. “We will have a jigsaw puzzle of fragmented obligations, where the future pandemic response might go different ways, similar to what we saw during the COVID-19 pandemic.” To make negotiations more efficient and fit to tackle the next pandemic, Villarreal suggested two negotiation processes could be combined. “There could be an agreement on where to put which provisions and in which instrument each provision would be located,” he proposed. “So why not negotiate everything together and then decide what goes where? Because first, it’s about knowing whether there is consensus at all.” However, he acknowledged that this was “quite a tall order” as it required the mandates for negotiating each would need to be changed. The final speaker, Elisa Morgera, Professor of Global Environmental Law at Strathclyde University Law School in the UK, said there were “several international multilateral beneficiary mechanisms” that could provide lessons for the current pandemic negotiations. “What has then come out after decades of studying fair and equitable benefit-sharing mechanisms in international environmental law is that, fundamentally, we’re looking at enhanced international cooperation,” said Morgera, who is also Director of the One Ocean Hub. “For research, we’re really looking at the research capacities in different states to be able to realise global objectives, and that fairness and equity boil down to: ‘what can we do in international law? What are the state obligations? What are the international mechanisms that we can devise to support fair research partnerships now in the Global North and global South countries where researchers are at very different stages in their capacities to contribute to the objectives?” She appealed for the creation of a system that supported both the sharing and flow of global benefits and “specific benefits for specific beneficiaries”. “We have those important references to human rights in the draft preamble of the pandemic instrument and I think this is a crucial lens under the UN Charter for any new international law development that has to do with health and, really, human survival and flourishing.” WHO to Share Information with Congolese Court in Sexual Abuse Cases of 13 Women 27/04/2023 Elaine Ruth Fletcher WHO’s Gaya Gamhewage on a visit to the Congolese city of Goma in November 2022, one of the hotspots of the 2018-2020 Ebola outbreak, where she committed to supporting the survivors of sexual assault and their families. Gaya Gamhewage, the agency’s lead official in prevention and response to sexual misconduct, describes WHO’s recent moves to bring justice to DRC’s victims. In a long-awaited move, the World Health Organization (WHO) is preparing to share files with the Congolese courts on the sexual exploitation and abuse complaints of 13 women who are pursuing criminal cases in local courts against WHO-linked Ebola responders that they say exploited and abused them. The abuse is alleged to have happened during the 2018-2020 Ebola outbreak in the Democratic Republic of the Congo (DRC). In a wide-ranging interview with Health Policy Watch, Gaya Gamhewage, WHO’s new director of Prevention and Response to Sexual Misconduct, spoke about WHO’s new initiatives to root out sexual misconduct from the Organization, also rebutting recent media reports that WHO has been foot-dragging on the pursuit of offenders in the DRC and had failed to liaise with DRC officials. Failings in WHO and other UN systems for preventing and managing sexual misconduct complaints have emerged as a major issue following revelations in 2020 by The New Humanitarian that dozens of women in the DRC has been sexually exploited, and even raped, by WHO, UN and other responders during the 2018-2020 Ebola outbreak, leaving behind a trail of victims, at least 20 of whom later bore children. A scathing report by WHO established the Independent Commission in September 2021 found that 21 out of the 83 identified perpetrators were linked to WHO. The report also found major shortcomings in WHO’s processes for preventing, reporting and managing cases. It called for investigations against alleged perpetrators and managers and “disciplinary sanctions” for those found culpable. But WHO was unable to take action in DRC courts against the alleged perpetrators until the victims of abuse themselves decided to act, explained Gamhewage, who took over in 2021 as acting director of WHO’s newly formed Department for the Prevention and Response to Sexual Misconduct at the height of the scandal. This is what just 13 women finally did, by accessing legal aid services by a local women-led NGO contracted by WHO and granting WHO permission to share their confidential information with local courts. Women pursuing cases are part of a larger group Ebola responders raise awareness about the deadly disease in Beni, DRC, at the height of the 2018-2020 pandemic. The 13 women are part of the larger group that testified in 2021 to the Independent Commission about the widespread patterns of abuse by men, who took advantage of UN, WHO staff or consultancy positions to obtain sex in exchange for money or jobs, in some cases raping local women as well. “Those [files] are being transferred directly to the courts that have asked us to provide them,” Gamhewage said. “Our WHO Legal Department received a letter from the courts that are prosecuting these cases, and now, because we’ve just received the victim’s consent, we are in the process of transfer.” Files from the ongoing investigation by the UN Office of Internal Oversight Services (UN OIOS), which is investigating all 83 DRC victims’ claims, will also be shared by WHO in relation to the same 13 survivors who have granted their permission, but those investigations are yet to be completed, she added. Gamhewage also noted that WHO has been providing medical, social and legal support to all identified victims of abuse, regardless of whether their alleged perpetrators were in fact affiliated with WHO or other agencies that responded the Ebola outbreak. As the lead agency in health emergencies, WHO has borne the brunt of media attention in the scandal but only a quarter of the actual claims were linked to WHO staff or consultants. “The total number of victims/ survivors identified by the Independent Commission is 83. Of those, 21 were associated with WHO at the time and the rest were perpetrators allegedly from other agencies,” Gamhewage said. Seven WHO consultants were already dismissed Ebola responders at the height of the DRC outbreak in full protective gear. The legal action being pursued locally in DRC is only one element in the spectrum of organizational disciplinary actions, Gamhewage also stressed. Seven WHO consultants were dismissed in the immediate aftermath of the Independent Commission report. “Where there was enough evidence, we were able to terminate the contracts of consultants who were accused,” she said. “And when the UN OIOS investigation reports are provided to WHO, we will take disciplinary action against our personnel in every [other] case in which allegations of SEA are substantiated,” she pledged. In addition, the names of 14 former WHO staff or consultants identified as alleged perpetrators by the Independent Commission were posted on the UN ClearCheck database. Through the database, some 33 UN entities share information about individuals who have “established allegations” related to sexual harassment, sexual exploitation and sexual abuse, with the aim of preventing their re-employment in the UN system. WHO is liaising with DRC government Meanwhile, WHO also has been liaising with DRC government officials on the handling of the cases, Gamhewage asserted. She contested recent media reports that the DRC government was uninformed, noting that she had personally traveled to the DRC in mid-March to brief officials and meet local NGOs to review the package of support that had been provided so far, and discuss options for more extended support to the survivors. However, on 24 March, just days after her visit, a sudden DRC Cabinet reshuffle occurred, and that meant the process had to start all over again. “In just the previous week, I was with the Health Minister, I sat in his office and I briefed him. And we had a very good agreement on how to move forward,” recalled Gamhewage. “But then the government changed, so of course now we have to have a new conversation. I hope to have an opportunity to brief them again very soon.” ‘We realized we had to do something’ WHO is changing all areas of work to prevent and respond to sexual misconduct, which is translating into broad impact and increased accountability. There is #NoExcuse for sexual exploitation, abuse and harassment. Dr @GayaG at yesterday’s media briefing ⬇️https://t.co/ayC5xkMV4V pic.twitter.com/MqruXXhLmW — World Health Organization (WHO) (@WHO) April 27, 2023 When Gamhewage took over her new role in 2021, she had a three-pronged aim: to find ways to support DRC victims; build WHO’s internal SEAH investigative capacity; and stimulate more effective outreach and education to prevent sexual misconduct from occurring. The painstaking work on the ground to support the DRC abuse victims took over a year, Gamhewage said. It involved reaching women in remote parts of conflict-ridden DRC, explaining to them their options, and connecting them with local support groups, In early 2022, WHO engaged a DRC legal aid organization to advise women who wished to pursue legal claims. In parallel it struck a deal with HEAL Africa, a health foundation based in the eastern DRC city of Goma, to provide emotional, physical or social support to women who wished to have such services. “All in all, WHO provided victim and survivor support – medical, psychosocial, legal and income generation support to 115 survivors who claimed they had experienced SEA regardless of which agency the alleged perpetrator belonged to,” she underlined. Regarding legal action, “in November 2021, and January 2022, we realized we had to do something while we were waiting for the [UN OIOS] investigation, so we transferred money to the UNFPA, to HEAL Africa, and to a women-led NGO that provides legal aid. And 13 of the survivors have now started pursuing justice through the legal aid NGO we hired in [local] legal systems,” she said. WHO’s Survivor Assistance Fund is unique in the UN system WHO’s Survivor Assistance Fund, established in September 2021 just after the Independent Commission report was published, covered the costs. She notes that the new fund is unique in the UN system insofar as it disperses funds directly – thus enabling “the fast allocation of funds to support victims and survivors of sexual misconduct” regardless of where they live. “The UN has a Trust Fund that supports United Nations and non-United Nations entities and organizations that provide victim assistance and support services and provides grants to NGOs that provide services to SEA survivors,” she observes. “But WHO is the only agency that has a fund for direct support, which can be accessed by individual survivors.” ‘When the UNIOS reports are provided, we will take disciplinary action’ She stressed, however, that the victims’ consent to share information with local courts was essential for any local legal action – and that also took time. “When the survivors were initially interviewed [by the Independent Commission], they only gave consent for the information to be shared with WHO, not with the national authorities,” Gamhewage pointed out. “So now, what we are doing is that we are collaborating on those 13 cases because we have consent. And as soon as we have the UN OIOS reports, we’ll hand those over too. “Our plan is whenever we get a victim’s consent for their information to be shared with the government, we will hand that over through the proper channels. Victim-centered approach “WHO is committed to transparency in its zero tolerance approach to sexual misconduct,” the UN’s health body said. Gamhewage rebutted claims that its response to sexual abuse victims in the DRC had been different than its treatment of claims in headquarters. Just last Monday, WHO announced the dismissal of the senior official Temo Waqanivalu, accused of sexually harassing the young British doctor, Rosie James, at the World Health Summit in Berlin last October. A decision on that case was issued within a period of just six months – the organization’s new benchmark for resolving claims. The process in DRC has taken much longer, she admits. In terms of the investigative process, WHO has little control since the high-profile DRC cases, uniquely, were turned over to the New York City-based UN OIOS, operating under the auspices of the UN Secretary General . But more generally, Gamhewage also contends that in the case of DRC, any outreach to victims that was not carefully planned in advance could also have boomeranged: “It wouldn’t be victim-centered, and they could be put in danger. “Even when we gave victim support, to identify these women in the villages, we had to be very careful and the case managers had to be very careful not to stigmatize them. “So, it’s actually a balance between protecting their rights, their wishes, but also their safety. And you know, survivors are, in a very, very tough area characterized by armed conflict, population displacement and extreme vulnerability and hardship.” ‘If you take shortcuts, everybody loses’ Gaya Gamhewage at a UN press conference on March 3, 2023, describing WHO’s moves to better prevent and respond to sexual misconduct. “Obviously if you are a survivor, you want this over as soon as possible, but these cases unfortunately take a long time.… It is from a victim/survivor point of view, very long. “But investigations also have to be robust; they have to be done properly. So if you take shortcuts, then everybody loses. What we aim for is a solid process that does not take too long, is fair and protects the rights and due process for all parties. Only by doing that will disciplinary action not be overturned on internal or external appeal. “And do you know how difficult it is to access people, even for survivor support? Sometimes it took five days [of local travel] to reach a community where the survivor was.” Even so, she concedes that before the recent changes in the system were made, “like most agencies, we took far too long for any investigation. We conducted an external audit to understand the real picture and took action to strengthen our investigation capacity. But we set an ambitious benchmark, and we tested it. The new six-month benchmark for the investigation of sexual abuse and exploitation cases from start to finish applies “wherever they occur in the world,” she asserts, rejecting the suggestion of a double standard. That time frame includes 120 days for investigation in sexual misconduct cases and another 60-80 days for a final decision on disciplinary action. “In fact we’re [now] the only UN agency to set a benchmark of 120 days.” Broader overhaul of programme to prevent and respond The DRC cases, meanwhile, have triggered a much broader overhaul of WHO’s system for preventing and responding to cases of sexual misconduct, she argues, echoing points made by WHO’s Director General Dr Tedros Adhanom Ghebreyesus at WHO’s Executive Board meeting in late January. The Organization hired more investigators for its Internal Oversight Services (IOS) department – and accelerated investigations clearing a backlog of sexual misconduct cases – not including the DRC complaints being handled by the wider UN OIOS team. As for critics who contend that some of the new WHO investigators are inexperienced, and only working as short-term consultants, she said: “It takes time to create posts, approve organigrams. But in the interim, what did we do? Because of the urgency, we hired qualified consultants as ‘surge’ capacity. They are a multi-disciplinary team experienced in trauma-informed, survivor-centered approaches to investigating sexual misconduct and other abusive conduct.” But over the long term, she maintains, WHO is developing a core team of permanent staff investigators specialized in sexual misconduct cases, who can be “supplemented if we need with surge capacity in the form of consultants.” “So we are now transitioning into a more stable way of moving forward. This, you can see in the confidence in the system by the number of people coming forward to a system that they didn’t trust before. “And of course, it can get better, and we would love to learn and improve, but the proof is that people are coming forward, compared to the past when they thought it was futile to raise a complaint,” she says, with reference to the gradual rise in the numbers of new complaints over the past year – including sharp rises in the African and Eastern Mediterranean regions. Meanwhile, the backlog of sexual misconduct cases that existed previously has been eliminated, she says. Although as the WHO dashboard on investigations reflects, there remains a backlog in WHO investigations into other forms of abusive conduct, in terms of sexual misconduct “we are working the cases in real time, and they are coming in mostly under 120 days. And excluding the DRC cases, WHO has dismissed eight personnel for sexual misconduct over the past seven months – more than ever before for a comparable period, Gamhewage pointed out. Investments in education and training – online and in countries WHO Director General Dr Tedros Adhanom Ghebreyesus speaks at the 152nd Executive Board meeting, 31 January about WHO’s reforms in prevention and response to sexual misconduct cases. WHO Director-General Dr Tedros Adhanom Ghebreyesus has publicly committed to a budget of $25 million a year for prevention and response to sexual misconduct, she adds. So far, that has included funding for the hiring of 20 full-time staff – along with the appointment and training of some 350 part-time focal points in 127 WHO country offices. A new policy on preventing and responding to sexual misconduct was issued in March 2023. That policy clearly places not only direct WHO beneficiaries of aid, but also members of the wider public who are abused or exploited by a WHO staff member or consultant, as within its scope. “All WHO country offices are now mandated to complete at least one risk assessment for sexual exploitation, abuse and harassment every year, and all personnel must take mandatory training and be subject to screening in the UN ClearCheck database that aims to prevent the re-hiring of sexual misconduct offenders. “And new standards and requirements have been set for health emergencies as the risk of sexual misconduct is high in humanitarian settings,” she says. Finally, the WHO has also invested in new public education programmes for prevention of sexual misconduct – an area of work that was just a “box to check” during the 2018-2020 Ebola response, according to DRC responders who spoke with Health Policy Watch after initial revelations of the abuse. More than 30,000 participants have already engaged in WHO’s live webinar series #NoExcuse, through the OpenWHO.org online learning platform – which targets not only WHO and UN staff but also the broader audiences of civil society and health workers engaged in emergency response. “This is a platform where people can learn as well as ask tough questions about the system and policies openly,” said Gamhewage. “It is supplemented by country-level training and visits.” ‘I cannot accept that we who are privileged…can also be the ones that harm’ Community advocates raise awareness about Ebolavirus on the outskirts of Beni, DRC in 2019 – an area wracked by poverty as well as armed conflict. Gamhewage, who is leading the entire effort since July 2021, built her own reputation over two decades at WHO as a skilled corporate coach, communicator and educator – teaching scientists and other staff to speak to the media, each other, and stakeholders about complex health topics in clear and understandable language. During the early days of the COVID pandemic, she was drafted to lead vital training and capacity building activities for the WHO Health Emergencies team, including the OpenWHO platform, followed by strategic development of online WHO Academy. The latter is now the world’s largest free open-source public health learning platform, offering some 200 public health courses, and with 7.5 million subscribers. A Sri Lankan born medical doctor and a public health professional, who has a reputation in WHO for frankly speaking her mind, she previously worked for Save the Children in her home country, as well as leading community health work in more than 15,000 communities for a large national NGO. In terms of her latest mission, many challenges remain: “While WHO gets its own house in order, we have to work better as the UN and humanitarian systems to address persisting problems – lack of effective community-based complaints mechanisms, poor or absent victim and survivor services and last but not least, inadequate collaboration or poor engagement with governments in countries where we operate,” sayd Gamhewage. “We are just at the start of a long, hard journey. I did not ever expect that I would have to do this job but now that I have that responsibility, I am fully committed to doing everything I can to change our systems, our culture and anything else that is required. Like most WHO colleagues, I cannot accept that we who are privileged to serve people can also be the ones that harm them.” Image Credits: Naomi Nolte IFRC emergency communication coordinator, WHO, Twitter/@OMSDRCONGO, World Bank Group/ V.Tremeau. New Africa CDC Head Proposes Airline Tax to Fund Health 27/04/2023 Paul Adepoju The new head of the Africa Centres for Disease Control and Prevention, Dr Jean Kaseya The new head of the Africa Centres for Disease Control and Prevention (Africa CDC), Dr Jean Kaseya, wants to introduce a tax on all airline passengers on the continent to help finance health. Days into the start of his term, the Congolese medical doctor revealed his manifesto for his four-year term at a media briefing on Thursday, his first public engagement since he was appointed to the post in February. His manifesto is synced with the pillars of Africa CDC’s New Public Health Order, said Kaseya, focusing on the health workforce, financing Africa’s health systems, building partnerships, reinforcing local and regional organizations to respond to all health issues, and boosting local manufacturing capacities on the continent for diagnostics, therapeutics and vaccines. Kaseya’s proposes actions meant to make Africa CDC to be more autonomous such as an African Air Tax to be paid by airline passengers with the proceeds going to financing Africa CDC’s health support to countries. Addressing journalists on Thursday, Kaseya said the tax is a way of extending Africa CDC’s autonomy from administrative autonomy to financial sustainability. “We have some ideas we are discussing with key people and our member states. Financial sustainability will give us the opportunity not only to sit respectfully with our partners to meet the needs of African people, it also gives us some flexibility to support responses during different occurrences,” he added. “By 2040, I will be 70 years old. I want to say to my children and grandchildren that I and my colleagues made Africa more independent by learning from what COVID-19 gave us as lessons,” Kaseya said. He noted that the agency now has “a very strong political mandate” because it is engaging directly with Africa’s heads of state and, as such, it must be properly aligned to ensure true representation of the respective countries’ health priorities. “We have with this power, the convening power, we are the umbrella of all health efforts on the continent. This means our strategic plan must reflect the agenda of the majority of countries in Africa,” he added. The continent also aims to increase its local vaccine production from the current 1% of vaccines to up to 60% by 2040. Challenges ahead When Kaseya’s election was announced, a number of several clear challenges emerged including getting all the countries on the continent to work together and in fulfilling the goals of the agency’s new public health order. Dr Javier Guzman, Director of Global Health Policy at the Center for Global Development, said that Kaseya will face a formidable series of challenges in advancing the Africa CDC strategy. Moreover, there is also the challenge of finding new ways to make the agency and its public health priorities stand out in the post-COVID era – amongst the multiple other challenges that Africa faces in trade, finance, climate change and diplomacy. But COVID-19 is no longer the priority that it used to be, Guzman noted. Instead, many countries are now preoccupied with a burgeoning fiscal and debt crisis, as well as multiple other competing priorities. These include accelerating the African Continental Free Trade Area, the main agenda item at the 36th AU Assembly, as well as confronting the growing effects of climate change and the war in Ukraine on food security, and beyond. “Dr Kaseya needs to bring a clear and focused vision to Africa CDC’s agenda, secure financial sustainability and build efficient operations, proactively reset the continental/regional balance, and secure the place of Africa CDC within a changing global health architecture. He will have the challenging job of maintaining the status of Africa CDC as the leading public health institution for the continent and delivering on the promise of an autonomous public health agency, a status granted by the African Union Assembly in February 2022,” Guzman said. Kaseya has over two decades of experience in public health in international institutions and the government of the Democratic Republic of Congo, revealed his priorities and strategic vision for the autonomous health agency. WHO has Terminated Eight Staffers’ Contracts for Sexual Misconduct in Past Seven Months 26/04/2023 Megha Kaveri Dr Gaya Gamhewage, Director, Prevention of Sexual Misconduct, WHO. Four World Health Organization (WHO) staff or consultants had their contracts terminated as a result of sexual misconduct allegations in the last quarter of 2022 – the most of any year so far. The contracts of another three people had already been terminated between January and March of this year, Dr Gaya Gamhewage, WHO’s Director of Prevention and Response to Sexual misconduct, told the media on Wednesday. The revelations came on the heels of news on Monday that WHO had dismissed senior manager Temo Waqanivalu following the conclusion of a high-profile investigation of sexual misconduct charges, first brought by a British doctor who had attended the World Health Summit last October in Berlin. “In the last year, our investigation team acted on not just the cases that were highlighted in the media, but have completed 120 investigations into sexual misconduct,” Gamhewage said in the briefing, adding that “72 other investigations are ongoing.” Gamhewage’s report was the most complete, in terms of numbers to date, of WHO actions since the agency WHO undertook a major revamp of its programmes for preventing and responding to allegations of sexual misconduct – including a major expansion of its investigations team. WHO overhaul came in wake of DRC sex scandal The WHO overhaul came in the wake of media revelations of widespread sexual exploitation, abuse and harassment, including cases of rape, by dozens of WHO and other UN responders to the 2018-2020 Ebola outbreak. In 2021, after a scathing report by a WHO-mandated Independent Commission investigation pointing to major shortcomings in the agency’s SEAH management, WHO announced worldwide reforms in both its investigative and prevention policies. However while the Independent Commission report also called for “disciplinary sanctions” against the alleged DRC perpetrators found culpable, Gamhewage’s report on Wednesday did not include the outcomes of their cases. That’s because the UN’s Office of Internal Oversight Services (UN OIOS) – and not WHO – are managing those cases separately and have yet to deliver their final reports, she said. “We are not investigating the DRC cases. They are all with UN OIS,” Gamhewage told Health Policy Watch in response to a follow-up question. “We can only take action once we receive their reports.” WHO changed ‘how we work, our structures, our culture’ But she asserted that WHO’s overhaul of its own internal systems was significant. “WHO started changing how we work, our structures, our culture, our processes over the last 18 months,” she said. “Because of the many changes we’ve made..having much stronger investigations capacity that is benchmarked, that’s fast and fair…providing better victim support …are having a cumulative effect that is changing our organization.” While acknowledging the role played by the media in breaking some of the taboos around addressing sexual misconduct, Gamhewage insisted that WHO also is “making changes with or without media spotlight.” And she issued a warning to media who have been covering the trail of sexual misconduct cases at the organisation saying that some stories risked violating the rights of victims and alleged perpetrators. “I want to caution that the media spotlight should not harm the due process that is owed to everybody involved,” she said, referring to the right of confidentiality of both victims and survivors. “It’s only when we protect these things will the disciplinary action that we take a stand. Otherwise, it can be appealed and nobody will win,” she said. Her remarks were echoed by WHO Director-General Dr Tedros Adhanom Ghebreyesus who added: “On the one hand, media helps; it’s the eyes and ears of the so keep doing that, we appreciate your work. On the other hand, I would like to stress that …. we see a lack of balance. In some of the reporting [there are] factual errors. And when we try to correct … there is refusal from some of the media outlets even to correct the factual errors.” “So we believe that you are helping us, but at the same time, I would urge you to… really make journalism balanced. And any factual issue you bring, we will take it seriously,” he promised. European Commission Finally Releases Pharma Law Reforms, Proposing Cuts to Market Exclusivity for New Drugs 26/04/2023 Kerry Cullinan EU Health Commissioner Stella Kyriakides Long-anticipated European Commission proposals to reform the European Union’s pharmaceutical legislation – the biggest shake-up in 20 years – were finally made public on Wednesday. The reforms are aimed particularly at addressing access and price disparities between European states, ensuring that all EU citizens have access to the same products at the same price, EU Health Commissioner Stella Kyriakides told a media briefing. “We are putting forward proposals to ensure that medicines reach patients everywhere in Europe, in a timely and equitable fashion,” said Kyriakides. Aside from high prices and medicine shortages, the Commission is particularly concerned about “unmet medical needs, rare diseases and antimicrobial resistance (AMR)”. The proposals have six policy objectives, namely to: create a single market for medicines, thus ensuring that all patients across the EU have “timely and equitable access to safe, effective, and affordable medicines”; offer “an attractive and innovation-friendly framework” for research, development, and production of medicines in Europe; speed up procedures significantly, particularly by reducing authorisation times for medicines to 180 days, so they reach patients faster; enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU; address antimicrobial resistance (AMR) and pharmaceuticals in the environment through a One Health approach; Make medicines more environmentally sustainable. We want medicine to be more accessible, available, and affordable. Our #EUPharmaStrategy legislative reform proposes a single market of medicines that: 🔸 is patient-centric🔹 fosters innovation🔸 fights antimicrobial resistance🔹 is environmentally friendly ↓#HealthUnion — European Commission (@EU_Commission) April 26, 2023 One of its proposals involves cutting drug market exclusivity for new medicines from 10 to eight years, after which the market will be opened to generics. However, drug companies that launch new medicines in all 27 EU member states within two years of development will still be able to get the extra two years’ exclusivity. In addition, manufacturers producing treatments for “unmet medical needs” will get an extra six months of protection. As an incentive to manufacturers to develop new antibiotics, the EC proposes “transferable exclusivity vouchers (TEVs)” for drug companies that give a year of protection to any of the company’s medicines. The proposals also envisage the EU being able to set up manufacturing of vaccines and drugs using compulsory licenses during public health emergencies. Positive precedent, says MSF Dimitri Eynikel, EU Policy Advisor for Médecins Sans Frontières (MSF) Access Campaign, said that “with some tweaks”, the reforms “could set a positive precedent towards enshrining access to medicines provisions in law”. “We applaud the proposal’s bid for greater transparency: obliging companies to open their books on all direct public funding received for the research and development of medicines is a critical step to ensure that medicines are priced appropriately and affordably for the people who need them,” said Eynikel. “In addition, plans for granting more effective compulsory licenses by suspending data and market exclusivity would be historic, and should encourage other countries and regions to adopt similar measures to secure the availability of affordable medicines.” But MSF is against the introduction of vouchers to encourage the development of new antimicrobials, warning that this could “prolong pharmaceutical monopolies, undermine generic competition and severely slow down people’s access to new and affordable medicines”. Pharma unhappy However, the reaction from pharmaceutical companies has been less positive. The European Federation of Pharmaceutical Industries and Associations (EFPIA) says that the proposals will “undermine research and development in Europe while failing to address access to medicines for patients.” EFPIA Director General Nathalie Moll laid the blame for slow access to medicines at the door of different systems in EU member states: “Fixing the tenfold variation in access to new medicines across the EU, requires all partners to urgently get round the table and address the real issues rather than unworkable EU-level legislation that is destined to fail.” “Although the revised legislation was meant to improve Europe’s competitiveness, the ‘net’ impact of policies set out across these proposals, in their current form, puts European competitiveness at risk,’ said EFPIA president Hubertus von Baumbach. Meanwhile, GSK Chief Executive Emma Walmsley told Reuters that weakening market exclusivity protections “could discourage companies from researching and launching treatments in Europe”. Process The European Parliament still has to pass the proposals, which means that there are still a number of opportunities for the proposals to be tweaked or changed. However, MSF’s Eynikel appealed to EU member states and the European Parliament not to water down the provisions on transparency and compulsory licenses. World Needs Ambitious Pandemic Accord – ‘Failing is Not an Option’ says German MP 26/04/2023 Alex Winston German MP Andrew Ullmann Many challenges remain in negotiating an international pandemic treaty, experts tell a committee of the German Parliament. As COVID-19 cases decline, multilateral polarization and a weary public leaves countries at risk should another global pandemic strike, German MP Andrew Ullmann stated on Monday at the German Parliament (Bundestag). The Bundestag’s Global Health Subcommittee held a technical briefing on the international pandemic accord currently being negotiated by World Health Organization (WHO) member states to ensure better global pandemic prevention, preparedness and response. “It is imperative to complete reforms to address the gaps in international health crises management,” Ullmann said. “We need to strive for an ambitious pandemic agreement. But, of course, this is easier said than done since interests between countries show a strong divide.” The pandemic accord aims to address areas currently not covered by the International Health Regulations (IHR) – the gobal laws to prevent the international spread of disease – and improve the international community’s ability to prevent and respond to pandemics in a just and effective manner. “There were huge gaps in the COVID-19 response, and there are three key objectives. First, one must be better prepared – from the community to the country, to the regional to the global level. Two, to have a better chance at preventing future pandemics, and three, to have a better and more coordinated response, and that is the aim,” Steven Solomon, WHO’s Principal Legal Officer, told the hearing. Steven Solomon, WHO Principal Legal Officer According to the process agreed in December 2021 by governments at a special session of the World Health Assembly, the WHO’s highest decision-making body, an intergovernmental negotiating body (INB) will aim to produce a final draft of the pandemic accord for consideration by the 77th World Health Assembly in 2024. Dr Clare Wenham, Associate Professor of Global Health Policy at the London School of Economics, told the hearing that the International Health Regulations were binding on member states but required maintaining a balance between “protecting against the international spread of disease and doing so in ways which are commensurate with the risk to international travel and trade, but it’s not a panacea.” Dr Clare Wenham Pointing out several other challenges surrounding the agreement and implementation of an international treaty, Wenham noted that “there have been challenges within the IHR around data sharing and whether there is free flowing and timely information being shared between countries and WHO.” China, in particular, has come under heavy scrutiny and criticism for its perceived refusal to share information or data on COVID-19. WHO is a member-state agency but has no physical compliance mechanism to enforce its member states to implement regulations other than, as Wenham pointed out, “name and shame mechanisms.” “There are challenges with financing and cooperation issues, so governments of higher income countries are supposed to support and assist and collaborate with low-income countries to be able to improve their capacities to respond to a pandemic,” Wenham said. “Also, other governance issues have come up during the pandemic of COVID, such as a lack of consideration of secondary impacts or pandemic policy.” Secondary impacts include such things as the effect of lockdowns on people’s physical and mental health and the financial implications that saw businesses affected worldwide. Zero draft The ‘zero draft’ of the accord, released in 2023, states that “all lives have equal value, and that therefore equity should be a principle, an indicator and an outcome of pandemic prevention, preparedness and response” stressed Dr Viviana Munoz Tellez of the South Centre, an intergovernmental organization based in Geneva that helps developing countries promote their common interests in the international arena. Munoz Tellez noted the deep inequalities between member states, also exacerbated by profit-driven medical and pharmaceutical services – which the poor can often not afford. Parts of the draft treaty text are already facing strong private sector opposition for clauses that some see as impinging too much on market forces, or threatening patent protections on drugs and treatment. For instance, one of the clauses of the ‘zero-draft’ of the treaty proposes that 20% of pandemic-related products, such as vaccines or equipment, should be allocated to WHO or other global health partners, which will then ensure equal distribution among member states. “It is a global problem that we have – a number of countries that are not able to meet even basic capacities for pandemic prevention, and that response to the COVID pandemic, we saw, was highly inequitable,” Munoz Tellez told the subcommittee’s hearing. “In that sense, there has been this drive to say that part of the response for future pandemics is to have equity at the center. “Private sector had the upper hand as we’ve generally seen overall in the R&D system right now. So we think this is also a very important opportunity for the pandemic treaty to improve the global system from research and development that responds better to public health needs, not just profit incentives.” Despite the many challenges remaining, Ullmann is hopeful that all parties will be willing to compromise and “contribute to a just and efficacious global health policy.” “Failing cannot be an option as the next pandemic can be just around the corner, and no single government or institution can address this threat by itself,” the German lawmaker added in an email to Health Policy Watch, just after the briefing ended. “For sure, it is imperative to break the cycle of panic and neglect once and for all.” Global Action Against Uganda’s Anti-Homosexuality Bill Amid Surge of Violent Attacks 25/04/2023 Kerry Cullinan Protestors in Washington DC. Protestors gathered outside Ugandan embassies worldwide on Tuesday for a global day of action against that country’s Anti-Homosexuality Bill, which criminalises all LGBTQ people and proposes a series of punishments ranging from fines to the death penalty. Violence against people suspected of being LGBTQ has already surged in the past month since Uganda’s Parliament passed the Bill with almost unanimous support. However, Ugandan President Yoweri Museveni declined last week to sign the Bill into law, sending it back to parliament last week with the instruction that it be “reinforced and strengthened”. While Museveni also congratulated MPs for rejecting “the pressure from imperialists”, he has been under intense pressure from the United Nations, US and European Union members not to sign the Bill. In addition, Uganda’s Deputy Attorney General has written to the Speaker highlighting why the Bill is unconstitutional, particularly focusing on the death penalty clauses. SOUND ON 🔊: President @KagutaMuseveni speaks about the Anti-Homosexuality Bill. pic.twitter.com/aXvU0YCplN — State House Uganda (@StateHouseUg) April 24, 2023 Since the Bill was passed a month ago, hate crimes and violence against LGBTQ people have risen sharply, according to the Human Rights and Awareness and Promotion Forum (HRAPF), a legal aid organisation. HIV services have also been affected, with some LGBTQ patients being afraid to attend clinics for fear of being arrested, according to The Lancet. In the past month, HRAPF has handled 59 cases involving LGBTQ or suspected LGBTQ persons. Forty of these cases “involved violence and violations targeting the victims purely on the basis of their presumed sexuality, and affected a total of 85 persons”. There is an exponential increase in cases of violence and violations against LGBTI persons fueled by the politicisation around the Anti Homosexuality Bill 2023 Read HRAPF’s report here>>> https://t.co/2Gre5T01Uh pic.twitter.com/lWSIQxNkcZ — HRAPF (@hrapf_uganda) April 24, 2023 “In one of these cases, a group of six people were arrested and charged with having carnal knowledge against the order of nature because the area local chairperson saw a video from a gay porn site in which one of the actors looked like one of the victims,” according to HRAPF, which itself faces fines simply for assisting LGBTQ clients. “In the most recent case, an athlete who was suspected to be a transgender woman was arrested by a mob, forcefully undressed and then forced to march through the streets naked while the crowd heckled her, threw objects at her, took her photos/ videos and even fondled her.” Meanwhile, a report released on Monday points out that Western governments and aid agencies – including the UK, Dutch, Norwegian and US governments – have donated $40 million to Ugandan anti-LGBTQ religious groups such as the Inter-Religious Council of Uganda since 2014. While the report acknowledges that there is no evidence “that any of this money specifically paid for anti-LGBTQI activities”, it adds that the aid and partnerships “can boost groups’ credibility, their reputations, and their access to power and other finance”. Kenya follows Uganda A Kenyan Member of Parliament, Peter Kaluma, has tabled an almost identical Bill to his parliament shortly after returning from a meeting in Uganda where leaders of a US anti-LGBTQ group, Family Watch International (FWI), delivered keynote addresses. FWI has a long history of involvement in anti-LGBTQ activities in Africa and was involved in promoting the forerunner of the current Uganda Bill, the so-called “kill the gays” Bill passed in 2014 but stopped by the courts on a technicality. FWI founder and leader Sharon Slater has doggedly pursued an anti-LGBT agenda for years, making a wide variety of claims including that LGBT people are more likely to be paedophiles. Slater, has also played a hand in the extreme anti-LGBTQ Bill before Ghana’s parliament. I recently had the honor of meeting with Ms. Sharon Slater, President of Family Watch International, & her team. They attended the first African Regional Inter-Parliamentary Conference in Uganda, focusing on global challenges that threaten African families & values. pic.twitter.com/8RP8ba4sLJ — Janet K Museveni (@JanetMuseveni) April 4, 2023 Slater, a Mormon from Arizona, has also been campaigning for years for African governments to ban comprehensive sexuality education in schools. A proponent of “conversion therapy”, a discredited approach that aims to change a person’s sexuality, Slater has apparently convinced Museveni that such ‘therapy’ should be promoted in the Bill to encourage people to renounce their homosexuality. Family Watch International’s Sharon Slater addresing Ugandan politicians Geopolitical complications While the Anti-Homosexuality Bill has drawn condemnation from European governments and the US, this has been muted as Western governments are in a race to woo African governments away from Russia and China. Russia also persecutes LGBTQ people and has a similar anti-rights agenda as Uganda. Meanwhile, South Africa, which outlaws discrimination against citizens on the basis of sexual orientation, is the only African country to mount protests against the Bill. The opposition Economic Freedom Fighters, which has significant youth support, has marched to the Ugandan Embassy in Pretoria. Meanwhile, on Tuesday the Secretary General of the ruling African National Congress said that discrimination and persecution were against the African Charter, and called on all states to “ensure that their citizens enjoy their full human rights”. Trump Politicisation of COVID Was a ‘Comorbidity’ in Disappointing US Pandemic Response 25/04/2023 Megha Kaveri President Donald Trump listens as Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, speaks to the press in 2020. An expert investigation into the US response to the COVID-19 pandemic has concluded that the country’s performance was the most disappointing in the world. The investigation’s report was launched on Tuesday as a book, Lessons from the COVID War, providing an in-depth analysis of America’s response to the pandemic and the aftermath by the COVID Crisis Group, an independent group of experts. No country’s performance in dealing with the pandemic was more disappointing than that of the US, according to the group. They came to this conclusion as the US excess deaths during the pandemic were around 40% higher than that of Europe, despite the US possessing deeper scientific knowledge about the virus and spending trillions of dollars to address it. Donald Trump’s politicking during the start of the pandemic when he was president is heavily criticised, with the authors concluding that his politicisation of the pandemic was a “comorbidity”. The book also examines the race to develop an effective vaccine against COVID-19 (Operation Warp Speed), COVID origins and the policies adopted by the federal and state governments. The COVID Crisis Group was born in 2021 out of a need to analyse the country’s COVID-19 response given that the pandemic killed more Americans than all US wars combined since the US War of Independence. The group consisted of 34 members – physicians, public health and policy experts led by Philp Zelikow, who led the official commission that looked into the 9/11 attacks. Lab-leak theory The report examines both the lab leak theory and the animal-human transmission theory of COVID-19, but doesn’t support either of these due to lack of sufficient evidence in both cases. The origins of COVID-19 has been a controversial topic as some believe that the virus might have broken out into the general population from the high-security laboratory that conducts research on coronaviruses at the Wuhan Institute of Virology in China. However, this theory has been disputed by many other eminent scientists and the World Health Organization (WHO), who believe that COVID-19 might have originated from a spillover event at a wet market in Wuhan province. The book comes down heavily on the US Centers for Disease Prevention and Control (CDC) and says that the agency took on a reactive role in a pandemic instead of proactively leading the way. Elaborating on the activities that went behind the development of successful mRNA vaccines against COVID, the book says that both Pfizer and Moderna enjoyed tremendous support from the federal government, either through upfront investment into development or as advance purchase guarantees that ran to billions of US dollars. It also emphasises how “Operation Warp Speed”, as it was known then, was a success only because of a perfect alignment of many other factors around it. Image Credits: flickr/The White House. Official White House Photo by Andrea Hanks. Africa to Manufacture New Malaria Vaccine? 24/04/2023 Paul Adepoju A healthcare worker gives a child a dose of the world’s first malaria vaccine, RTS,S. A second malaria vaccine has now been approved. IBADAN, Nigeria – There are high hopes that the R21/Matrix-M malaria vaccine recently approved by Ghana and Nigeria will be manufactured in Africa in the not-to-distant future – a brighter-than-usual prospect for this World Malaria Day (25 April). Earlier this month, Ghana’s Food and Drugs Authority (FDA) approved the R21/Matrix-M malaria vaccine manufactured by the Serum Institute of India (SII) for use in children aged from five months to three years, the age group at the highest risk of death from malaria. This was despite the vaccine not yet being given World Health Organization (WHO) prequalification approval. SII, the manufacturing and commercialisation license holder for the vaccine, described Ghana’s approval as the “first crucial step [that] will enable the vaccine to help Ghanaian and African children to effectively combat malaria”. “The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives,” said Adar Poonawalla, SII CEO. Shortly afterwards, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) also granted a “registration approval” for the vaccine to SII. The agency said it had received the dossier of the vaccine and it had been subjected to independent review at two levels. The agency added that the vaccine’s dossier substantially complied with best international standards, and that its Joint Review Committee had concluded the vaccine data was robust and met the criteria for efficacy, safety, and quality. Local production? Ghana’s regulator announced that the application for regulatory approval had been submitted by SII’s ‘local agent’, DEK, which expects to eventually manufacture the vaccine locally. “The status of the [Ghana] FDA Lab creates a great advantage for the local agent who hopefully will be manufacturing the malaria vaccine in Ghana in the near future,” the agency stated. A few days after the regulatory approval, a ground-breaking ceremony of the DEK Vaccines Limited’s vaccine fill-and-finish plant was held. The company is a private sector-led consortium of Ghanaian pharmaceutical companies. At the ceremony, Ghanaian President Nana Addo Dankwa Akufo-Addo, said it “will help our nation realise the dream of becoming self-sufficient in the manufacture of vaccines”. Meanwhile, Nigeria’s regulator announced Fidson Healthcare Ltd, a major local bourse-listed player in the country’s pharmaceutical industry, as the vaccine’s Marketing Authorization Holder (MAH). This authorizes the Nigerian firm licensed to distribute, sell and commercialize the vaccine in Nigeria. The Nigerian government also revealed in September 2022 that it had signed a local vaccine manufacturing agreement involving Biovaccines Nigeria Limited (a joint venture between the Federal Government of Nigeria and May & Baker Nigeria Plc), and SII. “The government has approved 15% of the vaccines that UNICEF normally supplies to Biovaccines to supply through contract manufacturing with the Serum Institute of India. With that, the institute will now be comfortable enough to come and join Biovaccines Nigeria in building its manufacturing plant here in Nigeria in Ota,” Nigerian health minister, Osagie Ehanire said. From Oxford to West Africa via India An infant receiving the RTS,S malaria vaccine in Ghana in 2019. Designed and developed at the University of Oxford, the vaccine has been tested in the United Kingdom, Thailand, and several African countries. A Phase Three trial that is underway in Burkina Faso, Kenya, Mali and Tanzania has enrolled 4,800 children and the results are expected later this year. While the regulator in Nigeria has also recommended an in-country Phase Four clinical trial or pharmacovigilance study in the implementation, given the peculiarity and heterogeneous nature of malaria in Nigeria, it noted that the efficacy results from the vaccine’s clinical trials contributed to its decision to approve it. Last year, the Oxford researchers and their partners reported from a Phase 2B trial that a booster dose of R21/Matrix-M at one year, following a primary three-dose regime, maintained high efficacy against malaria, and continued to meet the WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. This followed 2021 results from the Phase 2B trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77%. Recent data from the large phase III trial also show high levels of efficacy and a reassuring safety profile. Prof Adrian Hill, chief investigator for R21/Matrix-M programme, and Director of the Jenner Institute at the University of Oxford, described the regulatory approval of the vaccine as the culmination of 30 years of malaria vaccine research at Oxford. “I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children,” Hill said. The vaccine contains Novavax’s Matrix-M which is a saponin-based adjuvant that enhances the immune system response, making it more potent and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This technology has also been used successfully in Novavax’s COVID-19 vaccine and is a key component of other development-stage vaccines. An approval without a WHO prequalification Unlike the developments surrounding the approval of the COVID-19 vaccines in the African countries that largely followed a prequalification approval by the WHO, both Ghana and Nigerian regulators went ahead to approve the vaccine without any WHO approval. In addition to affirming their regulators’ competence and authorization to undertake such approvals, Dr Franklin Asiedu–Bekoe, Director of Public Health in Ghana, told Health Policy Watch that the vaccine – the second malaria vaccine that the country is rolling out – will be closely reviewed by the country’s team of scientists. “In Ghana, we have 93 districts that are now using the TRS,S. There are a number of districts that are yet to be using it. So if we have a vaccine, which is good, I think nothing stops us from using it,” he argued. Moreover, Prof William K. Ampofo, Secretary of the Presidential Committee on Vaccine Manufacturing and Development, Ghana, added that the approval was in response to the manufacturer’s application. “The vaccine was approved based on the application by the manufacturer Serum Institute. It was not an independent decision by the Ghana FDA. It was in response to the application by the Serum Institute for the R21 vaccine based on the data that had been accumulated,” Ampofo told Health Policy Watch. Local manufacturing elements of both approvals In the weeks before regulatory approval for the R21 vaccine, Ghana officially expanded access to the WHO-approved RTS,S malaria vaccine. Four years on, more than 4.5 million doses of the vaccine have been administered through the countries’ routine immunization programmes. “Community demand for the vaccine is high and the vaccine is well accepted in African communities, even when additional visits to vaccination clinics are required to receive the four-dose schedule,” WHO revealed. But RTS,S rollout has been plagued with concerns regarding its comparatively minimal efficacy, high cost and limited supply. In sharp contrast, R21’s demonstrably higher efficacy (more than 75% over 12 months) and comparatively lower cost ($3 compared with RTS,S’ $5 per dose) made it even more attractive to African countries – along with the manufacturer’s announcement of potential manufacturing capacities of more than 200 million doses annually. But beyond these essential factors are also considerations for local manufacturing from the outset of the vaccine’s introduction in Africa. WHO and Gavi falling in line Even though the WHO prequalification certification has not yet approved the R21 vaccine, the WHO has expressed its support for the vaccine, acknowledging on its website that a second malaria vaccine may be coming forward. “The WHO prequalification process is also underway. WHO will continue the thorough and efficient review of the R21 vaccine and awaits the submission of additional analyses by the vaccine developer,” the global health body said. Dr Phionah Atuhebwe, New Vaccines Introduction Officer at WHO AFRO Regional Office, added that the WHO is already evaluating the vaccine’s safety, efficacy, quality and programmatic suitability. “Ghana and Nigeria have not jumped the gun because it is expected that, at national level within their jurisdiction, the national regulatory authorities can also review data once they have received information from different vaccine developers,” she said. Gavi’s Aurelia Nguyen Aurelia Nguyen, Chief Programme and Strategy Officer for Gavi, the Vaccine Alliance, also told Health Policy Watch that the alliance is prepared to provide funding for the R21 malaria vaccine. “It is a hugely exciting development with the approvals that we’ve seen in Ghana and Nigeria. This is all moving us forward towards having a second vaccine,” Nguyen said. She noted that the restricted supply of the RTS,S made it “really important” to have several tools, in addition to affordability. “It’s not just about the volumes, it’s also about the affordability. Serum Institute has made a very important public commitment in terms of keeping the cost of the vaccines to $3 or less. So we really look forward to them honoring that commitment because ultimately, it will mean that more people are protected,” Nguyen concluded. Image Credits: WHO/Fanjan Combrink, WHO/M. Nieuwenhof, WHO. Powerful Partnership to Address Backslide in Childhood Vaccinations – But No Extra Funds 24/04/2023 Stefan Anderson “No child should die of a vaccine-preventable disease,” said WHO Director-General Tedros Adhanom Ghebreyesus. The world’s largest global health organizations have announced a partnership to reverse the years-long backslide in global childhood vaccination rates caused by the COVID-19 pandemic. An estimated 67 million children missed at least one essential vaccination between 2019 and 2021 and 50 million of these didn’t receive any vaccines – setting back childhood vaccination rates to their lowest level since 2008. But the “Big Catch-Up”, billed as an “extended effort” to restore vaccination levels in children to at least pre-pandemic levels and shore up essential health services for immunization programmes, does not contain any new financial commitments. Participants include the World Health Organization (WHO), UNICEF, the vaccine alliance Gavi, the Bill & Melinda Gates Foundation and a number of national and global health organizations. In the past three years, the overburdening and disruption of health services by COVID-19 containment efforts eroded over a decade of gains in routine childhood immunization levels. The vaccination schedules of millions of children around the world were knocked-off course, exposing them to life-threatening viruses that can be prevented by existing vaccines. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters the “Big Catch-Up” partnership does not involve any new financial commitments to bolster global childhood vaccination efforts. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters on Monday that preliminary estimates indicate that the backslide in childhood vaccinations has led to “at least” a five percent increase in mortality among children. “Every one of these lives that are lost is on top of the mortality that already exists because of the imperfection of the coverage and immunization programmes,” O’Brien said. “There will continue to be these children who are at risk going forward unless they are caught up.” Over 100 countries recorded declines in childhood vaccination rates during the pandemic, but three-quarters of the 25 million children who missed vaccinations in 2021 live in just 20 low- and middle-income countries. These will be a “particular focus” for the global coalition. “Millions of children and adolescents, particularly in lower-income countries, have missed out on life-saving vaccinations, while outbreaks of these deadly [preventable] diseases have risen,” said WHO director-general Tedros Adhanom Ghebreyesus. “Catching up is a top priority. No child should die of a vaccine-preventable disease.” Inequality is still behind vaccine access When UNICEF first began tracking childhood vaccination rates in 1980, just one in 10 children in the world’s poorest countries would “ever see a trained health worker or be immunized” before their first birthday. By the start of the next decade, seven in 10 children around the world were protected by vaccines – rising steadily to a height of 86% in 2019. Despite decades of progress, the story of children not receiving essential childhood vaccines remains one of inequality and poverty. One in five children in the world’s poorest households today are ‘zero-dose’, meaning they have never received a vaccine of any kind, according to UNICEF’s 2023 State of the World’s Children report released last week. In West and Central Africa, that number rises to nearly one in two, compared to one in 20 in the wealthiest countries. “Routine vaccines are typically a child’s first entry into their health system and so children who miss out on their early vaccines are at added risk of being cut out of healthcare in the long run,” UNICEF executive director Catherine Russel said. “The longer we wait to reach and vaccinate these children, the more vulnerable they become and the greater the risk of more deadly disease outbreaks.” Asked about the role of vaccine scepticism in dropping child vaccination rates, O’Brien stressed that while the global proliferation of misinformation around vaccines is “deeply concerning” – UNICEF found vaccine confidence dropped in 52 out of 55 countries – it remains a minor factor compared to income. “The main reason that kids are unvaccinated is not anti-vax [beliefs],” O’Brien said. “The main reason why children are unvaccinated has to do with access to services, quality of services, and the full availability of programmes.” Big ambitions, no extra funding No new funding to support the goal of returning childhood vaccination rates to pre-pandemic levels is included as part of the “Big Catch-Up”. “We’ve done an assessment of the resources that are out there, and we do feel that the resources are there,” O’Brien. “There are substantial resources already in-country and still available to countries through many different mechanisms.” Meanwhile, Medecins sans Frontieres (MSF) highlighted that children in conflict zones were particularly affected. “Despite the progress made in expanding global vaccination coverage, nearly 11 million of the un- and under-vaccinated infants live in fragile or humanitarian settings, including countries affected by conflict, and remain the most vulnerable to disease outbreaks,” said Dr Sharmila Shetty, Vaccines Medical Advisor for MSF’s Access Campaign. Africa’s burden According to estimates by WHO and UNICEF, the number of zero-dose and under-immunized African children rose by 16% between 2019 and 2021 to a cumulative total of about 33 million, nearly half the global figure. At a WHO AFRO press briefing last Thursday, Gavi, The Vaccine Alliance, revealed it is working in Sierra Leone and Ghana to ensure that the millions of children and adolescent girls who missed out on vaccines during the pandemic are protected. “We’re very, very happy to be marking in a few days, the 2023 edition of the Africa Vaccination Week, and it’s a really good opportunity for us to take stock and to remind ourselves of what we have achieved but also what we are dealing with in terms of recovering from a pretty unprecedented emergency during the pandemic,” said Aurelia Nguyen, Gavi’s Chief Programme and Strategy Officer. Nguyen said that Gavi is working closely with its partners to support countries in making up lost ground and building stronger, more resilient systems. The efforts will focus on on hard-to-reach communities and implementing national programmes that are able to reach children and communities more effectively. Gavi is also focusing on the human papillomavirus (HPV) vaccine program, which was one of the hardest hit during the pandemic. With cervical cancer being the most common cause of cancer death in nearly half of sub-Saharan African countries, Nguyen noted that the HPV vaccine can prevent up to 90% of cervical cancer cases. So far, Gavi said it has supported 20 African countries to produce the HPV vaccine and received $600 million in extra investment last year to revitalize the program and strengthen health systems. “As we think about many, many challenges ahead, we also are considering the opportunities and we have a young and growing population, and so it’s really our responsibility and opportunity to make sure that we don’t leave any child behind with immunization,” said Nguyen. Additional reporting by Paul Adepoju. Image Credits: WHO / Billy Miaron. 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. 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WHO to Share Information with Congolese Court in Sexual Abuse Cases of 13 Women 27/04/2023 Elaine Ruth Fletcher WHO’s Gaya Gamhewage on a visit to the Congolese city of Goma in November 2022, one of the hotspots of the 2018-2020 Ebola outbreak, where she committed to supporting the survivors of sexual assault and their families. Gaya Gamhewage, the agency’s lead official in prevention and response to sexual misconduct, describes WHO’s recent moves to bring justice to DRC’s victims. In a long-awaited move, the World Health Organization (WHO) is preparing to share files with the Congolese courts on the sexual exploitation and abuse complaints of 13 women who are pursuing criminal cases in local courts against WHO-linked Ebola responders that they say exploited and abused them. The abuse is alleged to have happened during the 2018-2020 Ebola outbreak in the Democratic Republic of the Congo (DRC). In a wide-ranging interview with Health Policy Watch, Gaya Gamhewage, WHO’s new director of Prevention and Response to Sexual Misconduct, spoke about WHO’s new initiatives to root out sexual misconduct from the Organization, also rebutting recent media reports that WHO has been foot-dragging on the pursuit of offenders in the DRC and had failed to liaise with DRC officials. Failings in WHO and other UN systems for preventing and managing sexual misconduct complaints have emerged as a major issue following revelations in 2020 by The New Humanitarian that dozens of women in the DRC has been sexually exploited, and even raped, by WHO, UN and other responders during the 2018-2020 Ebola outbreak, leaving behind a trail of victims, at least 20 of whom later bore children. A scathing report by WHO established the Independent Commission in September 2021 found that 21 out of the 83 identified perpetrators were linked to WHO. The report also found major shortcomings in WHO’s processes for preventing, reporting and managing cases. It called for investigations against alleged perpetrators and managers and “disciplinary sanctions” for those found culpable. But WHO was unable to take action in DRC courts against the alleged perpetrators until the victims of abuse themselves decided to act, explained Gamhewage, who took over in 2021 as acting director of WHO’s newly formed Department for the Prevention and Response to Sexual Misconduct at the height of the scandal. This is what just 13 women finally did, by accessing legal aid services by a local women-led NGO contracted by WHO and granting WHO permission to share their confidential information with local courts. Women pursuing cases are part of a larger group Ebola responders raise awareness about the deadly disease in Beni, DRC, at the height of the 2018-2020 pandemic. The 13 women are part of the larger group that testified in 2021 to the Independent Commission about the widespread patterns of abuse by men, who took advantage of UN, WHO staff or consultancy positions to obtain sex in exchange for money or jobs, in some cases raping local women as well. “Those [files] are being transferred directly to the courts that have asked us to provide them,” Gamhewage said. “Our WHO Legal Department received a letter from the courts that are prosecuting these cases, and now, because we’ve just received the victim’s consent, we are in the process of transfer.” Files from the ongoing investigation by the UN Office of Internal Oversight Services (UN OIOS), which is investigating all 83 DRC victims’ claims, will also be shared by WHO in relation to the same 13 survivors who have granted their permission, but those investigations are yet to be completed, she added. Gamhewage also noted that WHO has been providing medical, social and legal support to all identified victims of abuse, regardless of whether their alleged perpetrators were in fact affiliated with WHO or other agencies that responded the Ebola outbreak. As the lead agency in health emergencies, WHO has borne the brunt of media attention in the scandal but only a quarter of the actual claims were linked to WHO staff or consultants. “The total number of victims/ survivors identified by the Independent Commission is 83. Of those, 21 were associated with WHO at the time and the rest were perpetrators allegedly from other agencies,” Gamhewage said. Seven WHO consultants were already dismissed Ebola responders at the height of the DRC outbreak in full protective gear. The legal action being pursued locally in DRC is only one element in the spectrum of organizational disciplinary actions, Gamhewage also stressed. Seven WHO consultants were dismissed in the immediate aftermath of the Independent Commission report. “Where there was enough evidence, we were able to terminate the contracts of consultants who were accused,” she said. “And when the UN OIOS investigation reports are provided to WHO, we will take disciplinary action against our personnel in every [other] case in which allegations of SEA are substantiated,” she pledged. In addition, the names of 14 former WHO staff or consultants identified as alleged perpetrators by the Independent Commission were posted on the UN ClearCheck database. Through the database, some 33 UN entities share information about individuals who have “established allegations” related to sexual harassment, sexual exploitation and sexual abuse, with the aim of preventing their re-employment in the UN system. WHO is liaising with DRC government Meanwhile, WHO also has been liaising with DRC government officials on the handling of the cases, Gamhewage asserted. She contested recent media reports that the DRC government was uninformed, noting that she had personally traveled to the DRC in mid-March to brief officials and meet local NGOs to review the package of support that had been provided so far, and discuss options for more extended support to the survivors. However, on 24 March, just days after her visit, a sudden DRC Cabinet reshuffle occurred, and that meant the process had to start all over again. “In just the previous week, I was with the Health Minister, I sat in his office and I briefed him. And we had a very good agreement on how to move forward,” recalled Gamhewage. “But then the government changed, so of course now we have to have a new conversation. I hope to have an opportunity to brief them again very soon.” ‘We realized we had to do something’ WHO is changing all areas of work to prevent and respond to sexual misconduct, which is translating into broad impact and increased accountability. There is #NoExcuse for sexual exploitation, abuse and harassment. Dr @GayaG at yesterday’s media briefing ⬇️https://t.co/ayC5xkMV4V pic.twitter.com/MqruXXhLmW — World Health Organization (WHO) (@WHO) April 27, 2023 When Gamhewage took over her new role in 2021, she had a three-pronged aim: to find ways to support DRC victims; build WHO’s internal SEAH investigative capacity; and stimulate more effective outreach and education to prevent sexual misconduct from occurring. The painstaking work on the ground to support the DRC abuse victims took over a year, Gamhewage said. It involved reaching women in remote parts of conflict-ridden DRC, explaining to them their options, and connecting them with local support groups, In early 2022, WHO engaged a DRC legal aid organization to advise women who wished to pursue legal claims. In parallel it struck a deal with HEAL Africa, a health foundation based in the eastern DRC city of Goma, to provide emotional, physical or social support to women who wished to have such services. “All in all, WHO provided victim and survivor support – medical, psychosocial, legal and income generation support to 115 survivors who claimed they had experienced SEA regardless of which agency the alleged perpetrator belonged to,” she underlined. Regarding legal action, “in November 2021, and January 2022, we realized we had to do something while we were waiting for the [UN OIOS] investigation, so we transferred money to the UNFPA, to HEAL Africa, and to a women-led NGO that provides legal aid. And 13 of the survivors have now started pursuing justice through the legal aid NGO we hired in [local] legal systems,” she said. WHO’s Survivor Assistance Fund is unique in the UN system WHO’s Survivor Assistance Fund, established in September 2021 just after the Independent Commission report was published, covered the costs. She notes that the new fund is unique in the UN system insofar as it disperses funds directly – thus enabling “the fast allocation of funds to support victims and survivors of sexual misconduct” regardless of where they live. “The UN has a Trust Fund that supports United Nations and non-United Nations entities and organizations that provide victim assistance and support services and provides grants to NGOs that provide services to SEA survivors,” she observes. “But WHO is the only agency that has a fund for direct support, which can be accessed by individual survivors.” ‘When the UNIOS reports are provided, we will take disciplinary action’ She stressed, however, that the victims’ consent to share information with local courts was essential for any local legal action – and that also took time. “When the survivors were initially interviewed [by the Independent Commission], they only gave consent for the information to be shared with WHO, not with the national authorities,” Gamhewage pointed out. “So now, what we are doing is that we are collaborating on those 13 cases because we have consent. And as soon as we have the UN OIOS reports, we’ll hand those over too. “Our plan is whenever we get a victim’s consent for their information to be shared with the government, we will hand that over through the proper channels. Victim-centered approach “WHO is committed to transparency in its zero tolerance approach to sexual misconduct,” the UN’s health body said. Gamhewage rebutted claims that its response to sexual abuse victims in the DRC had been different than its treatment of claims in headquarters. Just last Monday, WHO announced the dismissal of the senior official Temo Waqanivalu, accused of sexually harassing the young British doctor, Rosie James, at the World Health Summit in Berlin last October. A decision on that case was issued within a period of just six months – the organization’s new benchmark for resolving claims. The process in DRC has taken much longer, she admits. In terms of the investigative process, WHO has little control since the high-profile DRC cases, uniquely, were turned over to the New York City-based UN OIOS, operating under the auspices of the UN Secretary General . But more generally, Gamhewage also contends that in the case of DRC, any outreach to victims that was not carefully planned in advance could also have boomeranged: “It wouldn’t be victim-centered, and they could be put in danger. “Even when we gave victim support, to identify these women in the villages, we had to be very careful and the case managers had to be very careful not to stigmatize them. “So, it’s actually a balance between protecting their rights, their wishes, but also their safety. And you know, survivors are, in a very, very tough area characterized by armed conflict, population displacement and extreme vulnerability and hardship.” ‘If you take shortcuts, everybody loses’ Gaya Gamhewage at a UN press conference on March 3, 2023, describing WHO’s moves to better prevent and respond to sexual misconduct. “Obviously if you are a survivor, you want this over as soon as possible, but these cases unfortunately take a long time.… It is from a victim/survivor point of view, very long. “But investigations also have to be robust; they have to be done properly. So if you take shortcuts, then everybody loses. What we aim for is a solid process that does not take too long, is fair and protects the rights and due process for all parties. Only by doing that will disciplinary action not be overturned on internal or external appeal. “And do you know how difficult it is to access people, even for survivor support? Sometimes it took five days [of local travel] to reach a community where the survivor was.” Even so, she concedes that before the recent changes in the system were made, “like most agencies, we took far too long for any investigation. We conducted an external audit to understand the real picture and took action to strengthen our investigation capacity. But we set an ambitious benchmark, and we tested it. The new six-month benchmark for the investigation of sexual abuse and exploitation cases from start to finish applies “wherever they occur in the world,” she asserts, rejecting the suggestion of a double standard. That time frame includes 120 days for investigation in sexual misconduct cases and another 60-80 days for a final decision on disciplinary action. “In fact we’re [now] the only UN agency to set a benchmark of 120 days.” Broader overhaul of programme to prevent and respond The DRC cases, meanwhile, have triggered a much broader overhaul of WHO’s system for preventing and responding to cases of sexual misconduct, she argues, echoing points made by WHO’s Director General Dr Tedros Adhanom Ghebreyesus at WHO’s Executive Board meeting in late January. The Organization hired more investigators for its Internal Oversight Services (IOS) department – and accelerated investigations clearing a backlog of sexual misconduct cases – not including the DRC complaints being handled by the wider UN OIOS team. As for critics who contend that some of the new WHO investigators are inexperienced, and only working as short-term consultants, she said: “It takes time to create posts, approve organigrams. But in the interim, what did we do? Because of the urgency, we hired qualified consultants as ‘surge’ capacity. They are a multi-disciplinary team experienced in trauma-informed, survivor-centered approaches to investigating sexual misconduct and other abusive conduct.” But over the long term, she maintains, WHO is developing a core team of permanent staff investigators specialized in sexual misconduct cases, who can be “supplemented if we need with surge capacity in the form of consultants.” “So we are now transitioning into a more stable way of moving forward. This, you can see in the confidence in the system by the number of people coming forward to a system that they didn’t trust before. “And of course, it can get better, and we would love to learn and improve, but the proof is that people are coming forward, compared to the past when they thought it was futile to raise a complaint,” she says, with reference to the gradual rise in the numbers of new complaints over the past year – including sharp rises in the African and Eastern Mediterranean regions. Meanwhile, the backlog of sexual misconduct cases that existed previously has been eliminated, she says. Although as the WHO dashboard on investigations reflects, there remains a backlog in WHO investigations into other forms of abusive conduct, in terms of sexual misconduct “we are working the cases in real time, and they are coming in mostly under 120 days. And excluding the DRC cases, WHO has dismissed eight personnel for sexual misconduct over the past seven months – more than ever before for a comparable period, Gamhewage pointed out. Investments in education and training – online and in countries WHO Director General Dr Tedros Adhanom Ghebreyesus speaks at the 152nd Executive Board meeting, 31 January about WHO’s reforms in prevention and response to sexual misconduct cases. WHO Director-General Dr Tedros Adhanom Ghebreyesus has publicly committed to a budget of $25 million a year for prevention and response to sexual misconduct, she adds. So far, that has included funding for the hiring of 20 full-time staff – along with the appointment and training of some 350 part-time focal points in 127 WHO country offices. A new policy on preventing and responding to sexual misconduct was issued in March 2023. That policy clearly places not only direct WHO beneficiaries of aid, but also members of the wider public who are abused or exploited by a WHO staff member or consultant, as within its scope. “All WHO country offices are now mandated to complete at least one risk assessment for sexual exploitation, abuse and harassment every year, and all personnel must take mandatory training and be subject to screening in the UN ClearCheck database that aims to prevent the re-hiring of sexual misconduct offenders. “And new standards and requirements have been set for health emergencies as the risk of sexual misconduct is high in humanitarian settings,” she says. Finally, the WHO has also invested in new public education programmes for prevention of sexual misconduct – an area of work that was just a “box to check” during the 2018-2020 Ebola response, according to DRC responders who spoke with Health Policy Watch after initial revelations of the abuse. More than 30,000 participants have already engaged in WHO’s live webinar series #NoExcuse, through the OpenWHO.org online learning platform – which targets not only WHO and UN staff but also the broader audiences of civil society and health workers engaged in emergency response. “This is a platform where people can learn as well as ask tough questions about the system and policies openly,” said Gamhewage. “It is supplemented by country-level training and visits.” ‘I cannot accept that we who are privileged…can also be the ones that harm’ Community advocates raise awareness about Ebolavirus on the outskirts of Beni, DRC in 2019 – an area wracked by poverty as well as armed conflict. Gamhewage, who is leading the entire effort since July 2021, built her own reputation over two decades at WHO as a skilled corporate coach, communicator and educator – teaching scientists and other staff to speak to the media, each other, and stakeholders about complex health topics in clear and understandable language. During the early days of the COVID pandemic, she was drafted to lead vital training and capacity building activities for the WHO Health Emergencies team, including the OpenWHO platform, followed by strategic development of online WHO Academy. The latter is now the world’s largest free open-source public health learning platform, offering some 200 public health courses, and with 7.5 million subscribers. A Sri Lankan born medical doctor and a public health professional, who has a reputation in WHO for frankly speaking her mind, she previously worked for Save the Children in her home country, as well as leading community health work in more than 15,000 communities for a large national NGO. In terms of her latest mission, many challenges remain: “While WHO gets its own house in order, we have to work better as the UN and humanitarian systems to address persisting problems – lack of effective community-based complaints mechanisms, poor or absent victim and survivor services and last but not least, inadequate collaboration or poor engagement with governments in countries where we operate,” sayd Gamhewage. “We are just at the start of a long, hard journey. I did not ever expect that I would have to do this job but now that I have that responsibility, I am fully committed to doing everything I can to change our systems, our culture and anything else that is required. Like most WHO colleagues, I cannot accept that we who are privileged to serve people can also be the ones that harm them.” Image Credits: Naomi Nolte IFRC emergency communication coordinator, WHO, Twitter/@OMSDRCONGO, World Bank Group/ V.Tremeau. New Africa CDC Head Proposes Airline Tax to Fund Health 27/04/2023 Paul Adepoju The new head of the Africa Centres for Disease Control and Prevention, Dr Jean Kaseya The new head of the Africa Centres for Disease Control and Prevention (Africa CDC), Dr Jean Kaseya, wants to introduce a tax on all airline passengers on the continent to help finance health. Days into the start of his term, the Congolese medical doctor revealed his manifesto for his four-year term at a media briefing on Thursday, his first public engagement since he was appointed to the post in February. His manifesto is synced with the pillars of Africa CDC’s New Public Health Order, said Kaseya, focusing on the health workforce, financing Africa’s health systems, building partnerships, reinforcing local and regional organizations to respond to all health issues, and boosting local manufacturing capacities on the continent for diagnostics, therapeutics and vaccines. Kaseya’s proposes actions meant to make Africa CDC to be more autonomous such as an African Air Tax to be paid by airline passengers with the proceeds going to financing Africa CDC’s health support to countries. Addressing journalists on Thursday, Kaseya said the tax is a way of extending Africa CDC’s autonomy from administrative autonomy to financial sustainability. “We have some ideas we are discussing with key people and our member states. Financial sustainability will give us the opportunity not only to sit respectfully with our partners to meet the needs of African people, it also gives us some flexibility to support responses during different occurrences,” he added. “By 2040, I will be 70 years old. I want to say to my children and grandchildren that I and my colleagues made Africa more independent by learning from what COVID-19 gave us as lessons,” Kaseya said. He noted that the agency now has “a very strong political mandate” because it is engaging directly with Africa’s heads of state and, as such, it must be properly aligned to ensure true representation of the respective countries’ health priorities. “We have with this power, the convening power, we are the umbrella of all health efforts on the continent. This means our strategic plan must reflect the agenda of the majority of countries in Africa,” he added. The continent also aims to increase its local vaccine production from the current 1% of vaccines to up to 60% by 2040. Challenges ahead When Kaseya’s election was announced, a number of several clear challenges emerged including getting all the countries on the continent to work together and in fulfilling the goals of the agency’s new public health order. Dr Javier Guzman, Director of Global Health Policy at the Center for Global Development, said that Kaseya will face a formidable series of challenges in advancing the Africa CDC strategy. Moreover, there is also the challenge of finding new ways to make the agency and its public health priorities stand out in the post-COVID era – amongst the multiple other challenges that Africa faces in trade, finance, climate change and diplomacy. But COVID-19 is no longer the priority that it used to be, Guzman noted. Instead, many countries are now preoccupied with a burgeoning fiscal and debt crisis, as well as multiple other competing priorities. These include accelerating the African Continental Free Trade Area, the main agenda item at the 36th AU Assembly, as well as confronting the growing effects of climate change and the war in Ukraine on food security, and beyond. “Dr Kaseya needs to bring a clear and focused vision to Africa CDC’s agenda, secure financial sustainability and build efficient operations, proactively reset the continental/regional balance, and secure the place of Africa CDC within a changing global health architecture. He will have the challenging job of maintaining the status of Africa CDC as the leading public health institution for the continent and delivering on the promise of an autonomous public health agency, a status granted by the African Union Assembly in February 2022,” Guzman said. Kaseya has over two decades of experience in public health in international institutions and the government of the Democratic Republic of Congo, revealed his priorities and strategic vision for the autonomous health agency. WHO has Terminated Eight Staffers’ Contracts for Sexual Misconduct in Past Seven Months 26/04/2023 Megha Kaveri Dr Gaya Gamhewage, Director, Prevention of Sexual Misconduct, WHO. Four World Health Organization (WHO) staff or consultants had their contracts terminated as a result of sexual misconduct allegations in the last quarter of 2022 – the most of any year so far. The contracts of another three people had already been terminated between January and March of this year, Dr Gaya Gamhewage, WHO’s Director of Prevention and Response to Sexual misconduct, told the media on Wednesday. The revelations came on the heels of news on Monday that WHO had dismissed senior manager Temo Waqanivalu following the conclusion of a high-profile investigation of sexual misconduct charges, first brought by a British doctor who had attended the World Health Summit last October in Berlin. “In the last year, our investigation team acted on not just the cases that were highlighted in the media, but have completed 120 investigations into sexual misconduct,” Gamhewage said in the briefing, adding that “72 other investigations are ongoing.” Gamhewage’s report was the most complete, in terms of numbers to date, of WHO actions since the agency WHO undertook a major revamp of its programmes for preventing and responding to allegations of sexual misconduct – including a major expansion of its investigations team. WHO overhaul came in wake of DRC sex scandal The WHO overhaul came in the wake of media revelations of widespread sexual exploitation, abuse and harassment, including cases of rape, by dozens of WHO and other UN responders to the 2018-2020 Ebola outbreak. In 2021, after a scathing report by a WHO-mandated Independent Commission investigation pointing to major shortcomings in the agency’s SEAH management, WHO announced worldwide reforms in both its investigative and prevention policies. However while the Independent Commission report also called for “disciplinary sanctions” against the alleged DRC perpetrators found culpable, Gamhewage’s report on Wednesday did not include the outcomes of their cases. That’s because the UN’s Office of Internal Oversight Services (UN OIOS) – and not WHO – are managing those cases separately and have yet to deliver their final reports, she said. “We are not investigating the DRC cases. They are all with UN OIS,” Gamhewage told Health Policy Watch in response to a follow-up question. “We can only take action once we receive their reports.” WHO changed ‘how we work, our structures, our culture’ But she asserted that WHO’s overhaul of its own internal systems was significant. “WHO started changing how we work, our structures, our culture, our processes over the last 18 months,” she said. “Because of the many changes we’ve made..having much stronger investigations capacity that is benchmarked, that’s fast and fair…providing better victim support …are having a cumulative effect that is changing our organization.” While acknowledging the role played by the media in breaking some of the taboos around addressing sexual misconduct, Gamhewage insisted that WHO also is “making changes with or without media spotlight.” And she issued a warning to media who have been covering the trail of sexual misconduct cases at the organisation saying that some stories risked violating the rights of victims and alleged perpetrators. “I want to caution that the media spotlight should not harm the due process that is owed to everybody involved,” she said, referring to the right of confidentiality of both victims and survivors. “It’s only when we protect these things will the disciplinary action that we take a stand. Otherwise, it can be appealed and nobody will win,” she said. Her remarks were echoed by WHO Director-General Dr Tedros Adhanom Ghebreyesus who added: “On the one hand, media helps; it’s the eyes and ears of the so keep doing that, we appreciate your work. On the other hand, I would like to stress that …. we see a lack of balance. In some of the reporting [there are] factual errors. And when we try to correct … there is refusal from some of the media outlets even to correct the factual errors.” “So we believe that you are helping us, but at the same time, I would urge you to… really make journalism balanced. And any factual issue you bring, we will take it seriously,” he promised. European Commission Finally Releases Pharma Law Reforms, Proposing Cuts to Market Exclusivity for New Drugs 26/04/2023 Kerry Cullinan EU Health Commissioner Stella Kyriakides Long-anticipated European Commission proposals to reform the European Union’s pharmaceutical legislation – the biggest shake-up in 20 years – were finally made public on Wednesday. The reforms are aimed particularly at addressing access and price disparities between European states, ensuring that all EU citizens have access to the same products at the same price, EU Health Commissioner Stella Kyriakides told a media briefing. “We are putting forward proposals to ensure that medicines reach patients everywhere in Europe, in a timely and equitable fashion,” said Kyriakides. Aside from high prices and medicine shortages, the Commission is particularly concerned about “unmet medical needs, rare diseases and antimicrobial resistance (AMR)”. The proposals have six policy objectives, namely to: create a single market for medicines, thus ensuring that all patients across the EU have “timely and equitable access to safe, effective, and affordable medicines”; offer “an attractive and innovation-friendly framework” for research, development, and production of medicines in Europe; speed up procedures significantly, particularly by reducing authorisation times for medicines to 180 days, so they reach patients faster; enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU; address antimicrobial resistance (AMR) and pharmaceuticals in the environment through a One Health approach; Make medicines more environmentally sustainable. We want medicine to be more accessible, available, and affordable. Our #EUPharmaStrategy legislative reform proposes a single market of medicines that: 🔸 is patient-centric🔹 fosters innovation🔸 fights antimicrobial resistance🔹 is environmentally friendly ↓#HealthUnion — European Commission (@EU_Commission) April 26, 2023 One of its proposals involves cutting drug market exclusivity for new medicines from 10 to eight years, after which the market will be opened to generics. However, drug companies that launch new medicines in all 27 EU member states within two years of development will still be able to get the extra two years’ exclusivity. In addition, manufacturers producing treatments for “unmet medical needs” will get an extra six months of protection. As an incentive to manufacturers to develop new antibiotics, the EC proposes “transferable exclusivity vouchers (TEVs)” for drug companies that give a year of protection to any of the company’s medicines. The proposals also envisage the EU being able to set up manufacturing of vaccines and drugs using compulsory licenses during public health emergencies. Positive precedent, says MSF Dimitri Eynikel, EU Policy Advisor for Médecins Sans Frontières (MSF) Access Campaign, said that “with some tweaks”, the reforms “could set a positive precedent towards enshrining access to medicines provisions in law”. “We applaud the proposal’s bid for greater transparency: obliging companies to open their books on all direct public funding received for the research and development of medicines is a critical step to ensure that medicines are priced appropriately and affordably for the people who need them,” said Eynikel. “In addition, plans for granting more effective compulsory licenses by suspending data and market exclusivity would be historic, and should encourage other countries and regions to adopt similar measures to secure the availability of affordable medicines.” But MSF is against the introduction of vouchers to encourage the development of new antimicrobials, warning that this could “prolong pharmaceutical monopolies, undermine generic competition and severely slow down people’s access to new and affordable medicines”. Pharma unhappy However, the reaction from pharmaceutical companies has been less positive. The European Federation of Pharmaceutical Industries and Associations (EFPIA) says that the proposals will “undermine research and development in Europe while failing to address access to medicines for patients.” EFPIA Director General Nathalie Moll laid the blame for slow access to medicines at the door of different systems in EU member states: “Fixing the tenfold variation in access to new medicines across the EU, requires all partners to urgently get round the table and address the real issues rather than unworkable EU-level legislation that is destined to fail.” “Although the revised legislation was meant to improve Europe’s competitiveness, the ‘net’ impact of policies set out across these proposals, in their current form, puts European competitiveness at risk,’ said EFPIA president Hubertus von Baumbach. Meanwhile, GSK Chief Executive Emma Walmsley told Reuters that weakening market exclusivity protections “could discourage companies from researching and launching treatments in Europe”. Process The European Parliament still has to pass the proposals, which means that there are still a number of opportunities for the proposals to be tweaked or changed. However, MSF’s Eynikel appealed to EU member states and the European Parliament not to water down the provisions on transparency and compulsory licenses. World Needs Ambitious Pandemic Accord – ‘Failing is Not an Option’ says German MP 26/04/2023 Alex Winston German MP Andrew Ullmann Many challenges remain in negotiating an international pandemic treaty, experts tell a committee of the German Parliament. As COVID-19 cases decline, multilateral polarization and a weary public leaves countries at risk should another global pandemic strike, German MP Andrew Ullmann stated on Monday at the German Parliament (Bundestag). The Bundestag’s Global Health Subcommittee held a technical briefing on the international pandemic accord currently being negotiated by World Health Organization (WHO) member states to ensure better global pandemic prevention, preparedness and response. “It is imperative to complete reforms to address the gaps in international health crises management,” Ullmann said. “We need to strive for an ambitious pandemic agreement. But, of course, this is easier said than done since interests between countries show a strong divide.” The pandemic accord aims to address areas currently not covered by the International Health Regulations (IHR) – the gobal laws to prevent the international spread of disease – and improve the international community’s ability to prevent and respond to pandemics in a just and effective manner. “There were huge gaps in the COVID-19 response, and there are three key objectives. First, one must be better prepared – from the community to the country, to the regional to the global level. Two, to have a better chance at preventing future pandemics, and three, to have a better and more coordinated response, and that is the aim,” Steven Solomon, WHO’s Principal Legal Officer, told the hearing. Steven Solomon, WHO Principal Legal Officer According to the process agreed in December 2021 by governments at a special session of the World Health Assembly, the WHO’s highest decision-making body, an intergovernmental negotiating body (INB) will aim to produce a final draft of the pandemic accord for consideration by the 77th World Health Assembly in 2024. Dr Clare Wenham, Associate Professor of Global Health Policy at the London School of Economics, told the hearing that the International Health Regulations were binding on member states but required maintaining a balance between “protecting against the international spread of disease and doing so in ways which are commensurate with the risk to international travel and trade, but it’s not a panacea.” Dr Clare Wenham Pointing out several other challenges surrounding the agreement and implementation of an international treaty, Wenham noted that “there have been challenges within the IHR around data sharing and whether there is free flowing and timely information being shared between countries and WHO.” China, in particular, has come under heavy scrutiny and criticism for its perceived refusal to share information or data on COVID-19. WHO is a member-state agency but has no physical compliance mechanism to enforce its member states to implement regulations other than, as Wenham pointed out, “name and shame mechanisms.” “There are challenges with financing and cooperation issues, so governments of higher income countries are supposed to support and assist and collaborate with low-income countries to be able to improve their capacities to respond to a pandemic,” Wenham said. “Also, other governance issues have come up during the pandemic of COVID, such as a lack of consideration of secondary impacts or pandemic policy.” Secondary impacts include such things as the effect of lockdowns on people’s physical and mental health and the financial implications that saw businesses affected worldwide. Zero draft The ‘zero draft’ of the accord, released in 2023, states that “all lives have equal value, and that therefore equity should be a principle, an indicator and an outcome of pandemic prevention, preparedness and response” stressed Dr Viviana Munoz Tellez of the South Centre, an intergovernmental organization based in Geneva that helps developing countries promote their common interests in the international arena. Munoz Tellez noted the deep inequalities between member states, also exacerbated by profit-driven medical and pharmaceutical services – which the poor can often not afford. Parts of the draft treaty text are already facing strong private sector opposition for clauses that some see as impinging too much on market forces, or threatening patent protections on drugs and treatment. For instance, one of the clauses of the ‘zero-draft’ of the treaty proposes that 20% of pandemic-related products, such as vaccines or equipment, should be allocated to WHO or other global health partners, which will then ensure equal distribution among member states. “It is a global problem that we have – a number of countries that are not able to meet even basic capacities for pandemic prevention, and that response to the COVID pandemic, we saw, was highly inequitable,” Munoz Tellez told the subcommittee’s hearing. “In that sense, there has been this drive to say that part of the response for future pandemics is to have equity at the center. “Private sector had the upper hand as we’ve generally seen overall in the R&D system right now. So we think this is also a very important opportunity for the pandemic treaty to improve the global system from research and development that responds better to public health needs, not just profit incentives.” Despite the many challenges remaining, Ullmann is hopeful that all parties will be willing to compromise and “contribute to a just and efficacious global health policy.” “Failing cannot be an option as the next pandemic can be just around the corner, and no single government or institution can address this threat by itself,” the German lawmaker added in an email to Health Policy Watch, just after the briefing ended. “For sure, it is imperative to break the cycle of panic and neglect once and for all.” Global Action Against Uganda’s Anti-Homosexuality Bill Amid Surge of Violent Attacks 25/04/2023 Kerry Cullinan Protestors in Washington DC. Protestors gathered outside Ugandan embassies worldwide on Tuesday for a global day of action against that country’s Anti-Homosexuality Bill, which criminalises all LGBTQ people and proposes a series of punishments ranging from fines to the death penalty. Violence against people suspected of being LGBTQ has already surged in the past month since Uganda’s Parliament passed the Bill with almost unanimous support. However, Ugandan President Yoweri Museveni declined last week to sign the Bill into law, sending it back to parliament last week with the instruction that it be “reinforced and strengthened”. While Museveni also congratulated MPs for rejecting “the pressure from imperialists”, he has been under intense pressure from the United Nations, US and European Union members not to sign the Bill. In addition, Uganda’s Deputy Attorney General has written to the Speaker highlighting why the Bill is unconstitutional, particularly focusing on the death penalty clauses. SOUND ON 🔊: President @KagutaMuseveni speaks about the Anti-Homosexuality Bill. pic.twitter.com/aXvU0YCplN — State House Uganda (@StateHouseUg) April 24, 2023 Since the Bill was passed a month ago, hate crimes and violence against LGBTQ people have risen sharply, according to the Human Rights and Awareness and Promotion Forum (HRAPF), a legal aid organisation. HIV services have also been affected, with some LGBTQ patients being afraid to attend clinics for fear of being arrested, according to The Lancet. In the past month, HRAPF has handled 59 cases involving LGBTQ or suspected LGBTQ persons. Forty of these cases “involved violence and violations targeting the victims purely on the basis of their presumed sexuality, and affected a total of 85 persons”. There is an exponential increase in cases of violence and violations against LGBTI persons fueled by the politicisation around the Anti Homosexuality Bill 2023 Read HRAPF’s report here>>> https://t.co/2Gre5T01Uh pic.twitter.com/lWSIQxNkcZ — HRAPF (@hrapf_uganda) April 24, 2023 “In one of these cases, a group of six people were arrested and charged with having carnal knowledge against the order of nature because the area local chairperson saw a video from a gay porn site in which one of the actors looked like one of the victims,” according to HRAPF, which itself faces fines simply for assisting LGBTQ clients. “In the most recent case, an athlete who was suspected to be a transgender woman was arrested by a mob, forcefully undressed and then forced to march through the streets naked while the crowd heckled her, threw objects at her, took her photos/ videos and even fondled her.” Meanwhile, a report released on Monday points out that Western governments and aid agencies – including the UK, Dutch, Norwegian and US governments – have donated $40 million to Ugandan anti-LGBTQ religious groups such as the Inter-Religious Council of Uganda since 2014. While the report acknowledges that there is no evidence “that any of this money specifically paid for anti-LGBTQI activities”, it adds that the aid and partnerships “can boost groups’ credibility, their reputations, and their access to power and other finance”. Kenya follows Uganda A Kenyan Member of Parliament, Peter Kaluma, has tabled an almost identical Bill to his parliament shortly after returning from a meeting in Uganda where leaders of a US anti-LGBTQ group, Family Watch International (FWI), delivered keynote addresses. FWI has a long history of involvement in anti-LGBTQ activities in Africa and was involved in promoting the forerunner of the current Uganda Bill, the so-called “kill the gays” Bill passed in 2014 but stopped by the courts on a technicality. FWI founder and leader Sharon Slater has doggedly pursued an anti-LGBT agenda for years, making a wide variety of claims including that LGBT people are more likely to be paedophiles. Slater, has also played a hand in the extreme anti-LGBTQ Bill before Ghana’s parliament. I recently had the honor of meeting with Ms. Sharon Slater, President of Family Watch International, & her team. They attended the first African Regional Inter-Parliamentary Conference in Uganda, focusing on global challenges that threaten African families & values. pic.twitter.com/8RP8ba4sLJ — Janet K Museveni (@JanetMuseveni) April 4, 2023 Slater, a Mormon from Arizona, has also been campaigning for years for African governments to ban comprehensive sexuality education in schools. A proponent of “conversion therapy”, a discredited approach that aims to change a person’s sexuality, Slater has apparently convinced Museveni that such ‘therapy’ should be promoted in the Bill to encourage people to renounce their homosexuality. Family Watch International’s Sharon Slater addresing Ugandan politicians Geopolitical complications While the Anti-Homosexuality Bill has drawn condemnation from European governments and the US, this has been muted as Western governments are in a race to woo African governments away from Russia and China. Russia also persecutes LGBTQ people and has a similar anti-rights agenda as Uganda. Meanwhile, South Africa, which outlaws discrimination against citizens on the basis of sexual orientation, is the only African country to mount protests against the Bill. The opposition Economic Freedom Fighters, which has significant youth support, has marched to the Ugandan Embassy in Pretoria. Meanwhile, on Tuesday the Secretary General of the ruling African National Congress said that discrimination and persecution were against the African Charter, and called on all states to “ensure that their citizens enjoy their full human rights”. Trump Politicisation of COVID Was a ‘Comorbidity’ in Disappointing US Pandemic Response 25/04/2023 Megha Kaveri President Donald Trump listens as Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, speaks to the press in 2020. An expert investigation into the US response to the COVID-19 pandemic has concluded that the country’s performance was the most disappointing in the world. The investigation’s report was launched on Tuesday as a book, Lessons from the COVID War, providing an in-depth analysis of America’s response to the pandemic and the aftermath by the COVID Crisis Group, an independent group of experts. No country’s performance in dealing with the pandemic was more disappointing than that of the US, according to the group. They came to this conclusion as the US excess deaths during the pandemic were around 40% higher than that of Europe, despite the US possessing deeper scientific knowledge about the virus and spending trillions of dollars to address it. Donald Trump’s politicking during the start of the pandemic when he was president is heavily criticised, with the authors concluding that his politicisation of the pandemic was a “comorbidity”. The book also examines the race to develop an effective vaccine against COVID-19 (Operation Warp Speed), COVID origins and the policies adopted by the federal and state governments. The COVID Crisis Group was born in 2021 out of a need to analyse the country’s COVID-19 response given that the pandemic killed more Americans than all US wars combined since the US War of Independence. The group consisted of 34 members – physicians, public health and policy experts led by Philp Zelikow, who led the official commission that looked into the 9/11 attacks. Lab-leak theory The report examines both the lab leak theory and the animal-human transmission theory of COVID-19, but doesn’t support either of these due to lack of sufficient evidence in both cases. The origins of COVID-19 has been a controversial topic as some believe that the virus might have broken out into the general population from the high-security laboratory that conducts research on coronaviruses at the Wuhan Institute of Virology in China. However, this theory has been disputed by many other eminent scientists and the World Health Organization (WHO), who believe that COVID-19 might have originated from a spillover event at a wet market in Wuhan province. The book comes down heavily on the US Centers for Disease Prevention and Control (CDC) and says that the agency took on a reactive role in a pandemic instead of proactively leading the way. Elaborating on the activities that went behind the development of successful mRNA vaccines against COVID, the book says that both Pfizer and Moderna enjoyed tremendous support from the federal government, either through upfront investment into development or as advance purchase guarantees that ran to billions of US dollars. It also emphasises how “Operation Warp Speed”, as it was known then, was a success only because of a perfect alignment of many other factors around it. Image Credits: flickr/The White House. Official White House Photo by Andrea Hanks. Africa to Manufacture New Malaria Vaccine? 24/04/2023 Paul Adepoju A healthcare worker gives a child a dose of the world’s first malaria vaccine, RTS,S. A second malaria vaccine has now been approved. IBADAN, Nigeria – There are high hopes that the R21/Matrix-M malaria vaccine recently approved by Ghana and Nigeria will be manufactured in Africa in the not-to-distant future – a brighter-than-usual prospect for this World Malaria Day (25 April). Earlier this month, Ghana’s Food and Drugs Authority (FDA) approved the R21/Matrix-M malaria vaccine manufactured by the Serum Institute of India (SII) for use in children aged from five months to three years, the age group at the highest risk of death from malaria. This was despite the vaccine not yet being given World Health Organization (WHO) prequalification approval. SII, the manufacturing and commercialisation license holder for the vaccine, described Ghana’s approval as the “first crucial step [that] will enable the vaccine to help Ghanaian and African children to effectively combat malaria”. “The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives,” said Adar Poonawalla, SII CEO. Shortly afterwards, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) also granted a “registration approval” for the vaccine to SII. The agency said it had received the dossier of the vaccine and it had been subjected to independent review at two levels. The agency added that the vaccine’s dossier substantially complied with best international standards, and that its Joint Review Committee had concluded the vaccine data was robust and met the criteria for efficacy, safety, and quality. Local production? Ghana’s regulator announced that the application for regulatory approval had been submitted by SII’s ‘local agent’, DEK, which expects to eventually manufacture the vaccine locally. “The status of the [Ghana] FDA Lab creates a great advantage for the local agent who hopefully will be manufacturing the malaria vaccine in Ghana in the near future,” the agency stated. A few days after the regulatory approval, a ground-breaking ceremony of the DEK Vaccines Limited’s vaccine fill-and-finish plant was held. The company is a private sector-led consortium of Ghanaian pharmaceutical companies. At the ceremony, Ghanaian President Nana Addo Dankwa Akufo-Addo, said it “will help our nation realise the dream of becoming self-sufficient in the manufacture of vaccines”. Meanwhile, Nigeria’s regulator announced Fidson Healthcare Ltd, a major local bourse-listed player in the country’s pharmaceutical industry, as the vaccine’s Marketing Authorization Holder (MAH). This authorizes the Nigerian firm licensed to distribute, sell and commercialize the vaccine in Nigeria. The Nigerian government also revealed in September 2022 that it had signed a local vaccine manufacturing agreement involving Biovaccines Nigeria Limited (a joint venture between the Federal Government of Nigeria and May & Baker Nigeria Plc), and SII. “The government has approved 15% of the vaccines that UNICEF normally supplies to Biovaccines to supply through contract manufacturing with the Serum Institute of India. With that, the institute will now be comfortable enough to come and join Biovaccines Nigeria in building its manufacturing plant here in Nigeria in Ota,” Nigerian health minister, Osagie Ehanire said. From Oxford to West Africa via India An infant receiving the RTS,S malaria vaccine in Ghana in 2019. Designed and developed at the University of Oxford, the vaccine has been tested in the United Kingdom, Thailand, and several African countries. A Phase Three trial that is underway in Burkina Faso, Kenya, Mali and Tanzania has enrolled 4,800 children and the results are expected later this year. While the regulator in Nigeria has also recommended an in-country Phase Four clinical trial or pharmacovigilance study in the implementation, given the peculiarity and heterogeneous nature of malaria in Nigeria, it noted that the efficacy results from the vaccine’s clinical trials contributed to its decision to approve it. Last year, the Oxford researchers and their partners reported from a Phase 2B trial that a booster dose of R21/Matrix-M at one year, following a primary three-dose regime, maintained high efficacy against malaria, and continued to meet the WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. This followed 2021 results from the Phase 2B trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77%. Recent data from the large phase III trial also show high levels of efficacy and a reassuring safety profile. Prof Adrian Hill, chief investigator for R21/Matrix-M programme, and Director of the Jenner Institute at the University of Oxford, described the regulatory approval of the vaccine as the culmination of 30 years of malaria vaccine research at Oxford. “I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children,” Hill said. The vaccine contains Novavax’s Matrix-M which is a saponin-based adjuvant that enhances the immune system response, making it more potent and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This technology has also been used successfully in Novavax’s COVID-19 vaccine and is a key component of other development-stage vaccines. An approval without a WHO prequalification Unlike the developments surrounding the approval of the COVID-19 vaccines in the African countries that largely followed a prequalification approval by the WHO, both Ghana and Nigerian regulators went ahead to approve the vaccine without any WHO approval. In addition to affirming their regulators’ competence and authorization to undertake such approvals, Dr Franklin Asiedu–Bekoe, Director of Public Health in Ghana, told Health Policy Watch that the vaccine – the second malaria vaccine that the country is rolling out – will be closely reviewed by the country’s team of scientists. “In Ghana, we have 93 districts that are now using the TRS,S. There are a number of districts that are yet to be using it. So if we have a vaccine, which is good, I think nothing stops us from using it,” he argued. Moreover, Prof William K. Ampofo, Secretary of the Presidential Committee on Vaccine Manufacturing and Development, Ghana, added that the approval was in response to the manufacturer’s application. “The vaccine was approved based on the application by the manufacturer Serum Institute. It was not an independent decision by the Ghana FDA. It was in response to the application by the Serum Institute for the R21 vaccine based on the data that had been accumulated,” Ampofo told Health Policy Watch. Local manufacturing elements of both approvals In the weeks before regulatory approval for the R21 vaccine, Ghana officially expanded access to the WHO-approved RTS,S malaria vaccine. Four years on, more than 4.5 million doses of the vaccine have been administered through the countries’ routine immunization programmes. “Community demand for the vaccine is high and the vaccine is well accepted in African communities, even when additional visits to vaccination clinics are required to receive the four-dose schedule,” WHO revealed. But RTS,S rollout has been plagued with concerns regarding its comparatively minimal efficacy, high cost and limited supply. In sharp contrast, R21’s demonstrably higher efficacy (more than 75% over 12 months) and comparatively lower cost ($3 compared with RTS,S’ $5 per dose) made it even more attractive to African countries – along with the manufacturer’s announcement of potential manufacturing capacities of more than 200 million doses annually. But beyond these essential factors are also considerations for local manufacturing from the outset of the vaccine’s introduction in Africa. WHO and Gavi falling in line Even though the WHO prequalification certification has not yet approved the R21 vaccine, the WHO has expressed its support for the vaccine, acknowledging on its website that a second malaria vaccine may be coming forward. “The WHO prequalification process is also underway. WHO will continue the thorough and efficient review of the R21 vaccine and awaits the submission of additional analyses by the vaccine developer,” the global health body said. Dr Phionah Atuhebwe, New Vaccines Introduction Officer at WHO AFRO Regional Office, added that the WHO is already evaluating the vaccine’s safety, efficacy, quality and programmatic suitability. “Ghana and Nigeria have not jumped the gun because it is expected that, at national level within their jurisdiction, the national regulatory authorities can also review data once they have received information from different vaccine developers,” she said. Gavi’s Aurelia Nguyen Aurelia Nguyen, Chief Programme and Strategy Officer for Gavi, the Vaccine Alliance, also told Health Policy Watch that the alliance is prepared to provide funding for the R21 malaria vaccine. “It is a hugely exciting development with the approvals that we’ve seen in Ghana and Nigeria. This is all moving us forward towards having a second vaccine,” Nguyen said. She noted that the restricted supply of the RTS,S made it “really important” to have several tools, in addition to affordability. “It’s not just about the volumes, it’s also about the affordability. Serum Institute has made a very important public commitment in terms of keeping the cost of the vaccines to $3 or less. So we really look forward to them honoring that commitment because ultimately, it will mean that more people are protected,” Nguyen concluded. Image Credits: WHO/Fanjan Combrink, WHO/M. Nieuwenhof, WHO. Powerful Partnership to Address Backslide in Childhood Vaccinations – But No Extra Funds 24/04/2023 Stefan Anderson “No child should die of a vaccine-preventable disease,” said WHO Director-General Tedros Adhanom Ghebreyesus. The world’s largest global health organizations have announced a partnership to reverse the years-long backslide in global childhood vaccination rates caused by the COVID-19 pandemic. An estimated 67 million children missed at least one essential vaccination between 2019 and 2021 and 50 million of these didn’t receive any vaccines – setting back childhood vaccination rates to their lowest level since 2008. But the “Big Catch-Up”, billed as an “extended effort” to restore vaccination levels in children to at least pre-pandemic levels and shore up essential health services for immunization programmes, does not contain any new financial commitments. Participants include the World Health Organization (WHO), UNICEF, the vaccine alliance Gavi, the Bill & Melinda Gates Foundation and a number of national and global health organizations. In the past three years, the overburdening and disruption of health services by COVID-19 containment efforts eroded over a decade of gains in routine childhood immunization levels. The vaccination schedules of millions of children around the world were knocked-off course, exposing them to life-threatening viruses that can be prevented by existing vaccines. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters the “Big Catch-Up” partnership does not involve any new financial commitments to bolster global childhood vaccination efforts. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters on Monday that preliminary estimates indicate that the backslide in childhood vaccinations has led to “at least” a five percent increase in mortality among children. “Every one of these lives that are lost is on top of the mortality that already exists because of the imperfection of the coverage and immunization programmes,” O’Brien said. “There will continue to be these children who are at risk going forward unless they are caught up.” Over 100 countries recorded declines in childhood vaccination rates during the pandemic, but three-quarters of the 25 million children who missed vaccinations in 2021 live in just 20 low- and middle-income countries. These will be a “particular focus” for the global coalition. “Millions of children and adolescents, particularly in lower-income countries, have missed out on life-saving vaccinations, while outbreaks of these deadly [preventable] diseases have risen,” said WHO director-general Tedros Adhanom Ghebreyesus. “Catching up is a top priority. No child should die of a vaccine-preventable disease.” Inequality is still behind vaccine access When UNICEF first began tracking childhood vaccination rates in 1980, just one in 10 children in the world’s poorest countries would “ever see a trained health worker or be immunized” before their first birthday. By the start of the next decade, seven in 10 children around the world were protected by vaccines – rising steadily to a height of 86% in 2019. Despite decades of progress, the story of children not receiving essential childhood vaccines remains one of inequality and poverty. One in five children in the world’s poorest households today are ‘zero-dose’, meaning they have never received a vaccine of any kind, according to UNICEF’s 2023 State of the World’s Children report released last week. In West and Central Africa, that number rises to nearly one in two, compared to one in 20 in the wealthiest countries. “Routine vaccines are typically a child’s first entry into their health system and so children who miss out on their early vaccines are at added risk of being cut out of healthcare in the long run,” UNICEF executive director Catherine Russel said. “The longer we wait to reach and vaccinate these children, the more vulnerable they become and the greater the risk of more deadly disease outbreaks.” Asked about the role of vaccine scepticism in dropping child vaccination rates, O’Brien stressed that while the global proliferation of misinformation around vaccines is “deeply concerning” – UNICEF found vaccine confidence dropped in 52 out of 55 countries – it remains a minor factor compared to income. “The main reason that kids are unvaccinated is not anti-vax [beliefs],” O’Brien said. “The main reason why children are unvaccinated has to do with access to services, quality of services, and the full availability of programmes.” Big ambitions, no extra funding No new funding to support the goal of returning childhood vaccination rates to pre-pandemic levels is included as part of the “Big Catch-Up”. “We’ve done an assessment of the resources that are out there, and we do feel that the resources are there,” O’Brien. “There are substantial resources already in-country and still available to countries through many different mechanisms.” Meanwhile, Medecins sans Frontieres (MSF) highlighted that children in conflict zones were particularly affected. “Despite the progress made in expanding global vaccination coverage, nearly 11 million of the un- and under-vaccinated infants live in fragile or humanitarian settings, including countries affected by conflict, and remain the most vulnerable to disease outbreaks,” said Dr Sharmila Shetty, Vaccines Medical Advisor for MSF’s Access Campaign. Africa’s burden According to estimates by WHO and UNICEF, the number of zero-dose and under-immunized African children rose by 16% between 2019 and 2021 to a cumulative total of about 33 million, nearly half the global figure. At a WHO AFRO press briefing last Thursday, Gavi, The Vaccine Alliance, revealed it is working in Sierra Leone and Ghana to ensure that the millions of children and adolescent girls who missed out on vaccines during the pandemic are protected. “We’re very, very happy to be marking in a few days, the 2023 edition of the Africa Vaccination Week, and it’s a really good opportunity for us to take stock and to remind ourselves of what we have achieved but also what we are dealing with in terms of recovering from a pretty unprecedented emergency during the pandemic,” said Aurelia Nguyen, Gavi’s Chief Programme and Strategy Officer. Nguyen said that Gavi is working closely with its partners to support countries in making up lost ground and building stronger, more resilient systems. The efforts will focus on on hard-to-reach communities and implementing national programmes that are able to reach children and communities more effectively. Gavi is also focusing on the human papillomavirus (HPV) vaccine program, which was one of the hardest hit during the pandemic. With cervical cancer being the most common cause of cancer death in nearly half of sub-Saharan African countries, Nguyen noted that the HPV vaccine can prevent up to 90% of cervical cancer cases. So far, Gavi said it has supported 20 African countries to produce the HPV vaccine and received $600 million in extra investment last year to revitalize the program and strengthen health systems. “As we think about many, many challenges ahead, we also are considering the opportunities and we have a young and growing population, and so it’s really our responsibility and opportunity to make sure that we don’t leave any child behind with immunization,” said Nguyen. Additional reporting by Paul Adepoju. Image Credits: WHO / Billy Miaron. 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. 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New Africa CDC Head Proposes Airline Tax to Fund Health 27/04/2023 Paul Adepoju The new head of the Africa Centres for Disease Control and Prevention, Dr Jean Kaseya The new head of the Africa Centres for Disease Control and Prevention (Africa CDC), Dr Jean Kaseya, wants to introduce a tax on all airline passengers on the continent to help finance health. Days into the start of his term, the Congolese medical doctor revealed his manifesto for his four-year term at a media briefing on Thursday, his first public engagement since he was appointed to the post in February. His manifesto is synced with the pillars of Africa CDC’s New Public Health Order, said Kaseya, focusing on the health workforce, financing Africa’s health systems, building partnerships, reinforcing local and regional organizations to respond to all health issues, and boosting local manufacturing capacities on the continent for diagnostics, therapeutics and vaccines. Kaseya’s proposes actions meant to make Africa CDC to be more autonomous such as an African Air Tax to be paid by airline passengers with the proceeds going to financing Africa CDC’s health support to countries. Addressing journalists on Thursday, Kaseya said the tax is a way of extending Africa CDC’s autonomy from administrative autonomy to financial sustainability. “We have some ideas we are discussing with key people and our member states. Financial sustainability will give us the opportunity not only to sit respectfully with our partners to meet the needs of African people, it also gives us some flexibility to support responses during different occurrences,” he added. “By 2040, I will be 70 years old. I want to say to my children and grandchildren that I and my colleagues made Africa more independent by learning from what COVID-19 gave us as lessons,” Kaseya said. He noted that the agency now has “a very strong political mandate” because it is engaging directly with Africa’s heads of state and, as such, it must be properly aligned to ensure true representation of the respective countries’ health priorities. “We have with this power, the convening power, we are the umbrella of all health efforts on the continent. This means our strategic plan must reflect the agenda of the majority of countries in Africa,” he added. The continent also aims to increase its local vaccine production from the current 1% of vaccines to up to 60% by 2040. Challenges ahead When Kaseya’s election was announced, a number of several clear challenges emerged including getting all the countries on the continent to work together and in fulfilling the goals of the agency’s new public health order. Dr Javier Guzman, Director of Global Health Policy at the Center for Global Development, said that Kaseya will face a formidable series of challenges in advancing the Africa CDC strategy. Moreover, there is also the challenge of finding new ways to make the agency and its public health priorities stand out in the post-COVID era – amongst the multiple other challenges that Africa faces in trade, finance, climate change and diplomacy. But COVID-19 is no longer the priority that it used to be, Guzman noted. Instead, many countries are now preoccupied with a burgeoning fiscal and debt crisis, as well as multiple other competing priorities. These include accelerating the African Continental Free Trade Area, the main agenda item at the 36th AU Assembly, as well as confronting the growing effects of climate change and the war in Ukraine on food security, and beyond. “Dr Kaseya needs to bring a clear and focused vision to Africa CDC’s agenda, secure financial sustainability and build efficient operations, proactively reset the continental/regional balance, and secure the place of Africa CDC within a changing global health architecture. He will have the challenging job of maintaining the status of Africa CDC as the leading public health institution for the continent and delivering on the promise of an autonomous public health agency, a status granted by the African Union Assembly in February 2022,” Guzman said. Kaseya has over two decades of experience in public health in international institutions and the government of the Democratic Republic of Congo, revealed his priorities and strategic vision for the autonomous health agency. WHO has Terminated Eight Staffers’ Contracts for Sexual Misconduct in Past Seven Months 26/04/2023 Megha Kaveri Dr Gaya Gamhewage, Director, Prevention of Sexual Misconduct, WHO. Four World Health Organization (WHO) staff or consultants had their contracts terminated as a result of sexual misconduct allegations in the last quarter of 2022 – the most of any year so far. The contracts of another three people had already been terminated between January and March of this year, Dr Gaya Gamhewage, WHO’s Director of Prevention and Response to Sexual misconduct, told the media on Wednesday. The revelations came on the heels of news on Monday that WHO had dismissed senior manager Temo Waqanivalu following the conclusion of a high-profile investigation of sexual misconduct charges, first brought by a British doctor who had attended the World Health Summit last October in Berlin. “In the last year, our investigation team acted on not just the cases that were highlighted in the media, but have completed 120 investigations into sexual misconduct,” Gamhewage said in the briefing, adding that “72 other investigations are ongoing.” Gamhewage’s report was the most complete, in terms of numbers to date, of WHO actions since the agency WHO undertook a major revamp of its programmes for preventing and responding to allegations of sexual misconduct – including a major expansion of its investigations team. WHO overhaul came in wake of DRC sex scandal The WHO overhaul came in the wake of media revelations of widespread sexual exploitation, abuse and harassment, including cases of rape, by dozens of WHO and other UN responders to the 2018-2020 Ebola outbreak. In 2021, after a scathing report by a WHO-mandated Independent Commission investigation pointing to major shortcomings in the agency’s SEAH management, WHO announced worldwide reforms in both its investigative and prevention policies. However while the Independent Commission report also called for “disciplinary sanctions” against the alleged DRC perpetrators found culpable, Gamhewage’s report on Wednesday did not include the outcomes of their cases. That’s because the UN’s Office of Internal Oversight Services (UN OIOS) – and not WHO – are managing those cases separately and have yet to deliver their final reports, she said. “We are not investigating the DRC cases. They are all with UN OIS,” Gamhewage told Health Policy Watch in response to a follow-up question. “We can only take action once we receive their reports.” WHO changed ‘how we work, our structures, our culture’ But she asserted that WHO’s overhaul of its own internal systems was significant. “WHO started changing how we work, our structures, our culture, our processes over the last 18 months,” she said. “Because of the many changes we’ve made..having much stronger investigations capacity that is benchmarked, that’s fast and fair…providing better victim support …are having a cumulative effect that is changing our organization.” While acknowledging the role played by the media in breaking some of the taboos around addressing sexual misconduct, Gamhewage insisted that WHO also is “making changes with or without media spotlight.” And she issued a warning to media who have been covering the trail of sexual misconduct cases at the organisation saying that some stories risked violating the rights of victims and alleged perpetrators. “I want to caution that the media spotlight should not harm the due process that is owed to everybody involved,” she said, referring to the right of confidentiality of both victims and survivors. “It’s only when we protect these things will the disciplinary action that we take a stand. Otherwise, it can be appealed and nobody will win,” she said. Her remarks were echoed by WHO Director-General Dr Tedros Adhanom Ghebreyesus who added: “On the one hand, media helps; it’s the eyes and ears of the so keep doing that, we appreciate your work. On the other hand, I would like to stress that …. we see a lack of balance. In some of the reporting [there are] factual errors. And when we try to correct … there is refusal from some of the media outlets even to correct the factual errors.” “So we believe that you are helping us, but at the same time, I would urge you to… really make journalism balanced. And any factual issue you bring, we will take it seriously,” he promised. European Commission Finally Releases Pharma Law Reforms, Proposing Cuts to Market Exclusivity for New Drugs 26/04/2023 Kerry Cullinan EU Health Commissioner Stella Kyriakides Long-anticipated European Commission proposals to reform the European Union’s pharmaceutical legislation – the biggest shake-up in 20 years – were finally made public on Wednesday. The reforms are aimed particularly at addressing access and price disparities between European states, ensuring that all EU citizens have access to the same products at the same price, EU Health Commissioner Stella Kyriakides told a media briefing. “We are putting forward proposals to ensure that medicines reach patients everywhere in Europe, in a timely and equitable fashion,” said Kyriakides. Aside from high prices and medicine shortages, the Commission is particularly concerned about “unmet medical needs, rare diseases and antimicrobial resistance (AMR)”. The proposals have six policy objectives, namely to: create a single market for medicines, thus ensuring that all patients across the EU have “timely and equitable access to safe, effective, and affordable medicines”; offer “an attractive and innovation-friendly framework” for research, development, and production of medicines in Europe; speed up procedures significantly, particularly by reducing authorisation times for medicines to 180 days, so they reach patients faster; enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU; address antimicrobial resistance (AMR) and pharmaceuticals in the environment through a One Health approach; Make medicines more environmentally sustainable. We want medicine to be more accessible, available, and affordable. Our #EUPharmaStrategy legislative reform proposes a single market of medicines that: 🔸 is patient-centric🔹 fosters innovation🔸 fights antimicrobial resistance🔹 is environmentally friendly ↓#HealthUnion — European Commission (@EU_Commission) April 26, 2023 One of its proposals involves cutting drug market exclusivity for new medicines from 10 to eight years, after which the market will be opened to generics. However, drug companies that launch new medicines in all 27 EU member states within two years of development will still be able to get the extra two years’ exclusivity. In addition, manufacturers producing treatments for “unmet medical needs” will get an extra six months of protection. As an incentive to manufacturers to develop new antibiotics, the EC proposes “transferable exclusivity vouchers (TEVs)” for drug companies that give a year of protection to any of the company’s medicines. The proposals also envisage the EU being able to set up manufacturing of vaccines and drugs using compulsory licenses during public health emergencies. Positive precedent, says MSF Dimitri Eynikel, EU Policy Advisor for Médecins Sans Frontières (MSF) Access Campaign, said that “with some tweaks”, the reforms “could set a positive precedent towards enshrining access to medicines provisions in law”. “We applaud the proposal’s bid for greater transparency: obliging companies to open their books on all direct public funding received for the research and development of medicines is a critical step to ensure that medicines are priced appropriately and affordably for the people who need them,” said Eynikel. “In addition, plans for granting more effective compulsory licenses by suspending data and market exclusivity would be historic, and should encourage other countries and regions to adopt similar measures to secure the availability of affordable medicines.” But MSF is against the introduction of vouchers to encourage the development of new antimicrobials, warning that this could “prolong pharmaceutical monopolies, undermine generic competition and severely slow down people’s access to new and affordable medicines”. Pharma unhappy However, the reaction from pharmaceutical companies has been less positive. The European Federation of Pharmaceutical Industries and Associations (EFPIA) says that the proposals will “undermine research and development in Europe while failing to address access to medicines for patients.” EFPIA Director General Nathalie Moll laid the blame for slow access to medicines at the door of different systems in EU member states: “Fixing the tenfold variation in access to new medicines across the EU, requires all partners to urgently get round the table and address the real issues rather than unworkable EU-level legislation that is destined to fail.” “Although the revised legislation was meant to improve Europe’s competitiveness, the ‘net’ impact of policies set out across these proposals, in their current form, puts European competitiveness at risk,’ said EFPIA president Hubertus von Baumbach. Meanwhile, GSK Chief Executive Emma Walmsley told Reuters that weakening market exclusivity protections “could discourage companies from researching and launching treatments in Europe”. Process The European Parliament still has to pass the proposals, which means that there are still a number of opportunities for the proposals to be tweaked or changed. However, MSF’s Eynikel appealed to EU member states and the European Parliament not to water down the provisions on transparency and compulsory licenses. World Needs Ambitious Pandemic Accord – ‘Failing is Not an Option’ says German MP 26/04/2023 Alex Winston German MP Andrew Ullmann Many challenges remain in negotiating an international pandemic treaty, experts tell a committee of the German Parliament. As COVID-19 cases decline, multilateral polarization and a weary public leaves countries at risk should another global pandemic strike, German MP Andrew Ullmann stated on Monday at the German Parliament (Bundestag). The Bundestag’s Global Health Subcommittee held a technical briefing on the international pandemic accord currently being negotiated by World Health Organization (WHO) member states to ensure better global pandemic prevention, preparedness and response. “It is imperative to complete reforms to address the gaps in international health crises management,” Ullmann said. “We need to strive for an ambitious pandemic agreement. But, of course, this is easier said than done since interests between countries show a strong divide.” The pandemic accord aims to address areas currently not covered by the International Health Regulations (IHR) – the gobal laws to prevent the international spread of disease – and improve the international community’s ability to prevent and respond to pandemics in a just and effective manner. “There were huge gaps in the COVID-19 response, and there are three key objectives. First, one must be better prepared – from the community to the country, to the regional to the global level. Two, to have a better chance at preventing future pandemics, and three, to have a better and more coordinated response, and that is the aim,” Steven Solomon, WHO’s Principal Legal Officer, told the hearing. Steven Solomon, WHO Principal Legal Officer According to the process agreed in December 2021 by governments at a special session of the World Health Assembly, the WHO’s highest decision-making body, an intergovernmental negotiating body (INB) will aim to produce a final draft of the pandemic accord for consideration by the 77th World Health Assembly in 2024. Dr Clare Wenham, Associate Professor of Global Health Policy at the London School of Economics, told the hearing that the International Health Regulations were binding on member states but required maintaining a balance between “protecting against the international spread of disease and doing so in ways which are commensurate with the risk to international travel and trade, but it’s not a panacea.” Dr Clare Wenham Pointing out several other challenges surrounding the agreement and implementation of an international treaty, Wenham noted that “there have been challenges within the IHR around data sharing and whether there is free flowing and timely information being shared between countries and WHO.” China, in particular, has come under heavy scrutiny and criticism for its perceived refusal to share information or data on COVID-19. WHO is a member-state agency but has no physical compliance mechanism to enforce its member states to implement regulations other than, as Wenham pointed out, “name and shame mechanisms.” “There are challenges with financing and cooperation issues, so governments of higher income countries are supposed to support and assist and collaborate with low-income countries to be able to improve their capacities to respond to a pandemic,” Wenham said. “Also, other governance issues have come up during the pandemic of COVID, such as a lack of consideration of secondary impacts or pandemic policy.” Secondary impacts include such things as the effect of lockdowns on people’s physical and mental health and the financial implications that saw businesses affected worldwide. Zero draft The ‘zero draft’ of the accord, released in 2023, states that “all lives have equal value, and that therefore equity should be a principle, an indicator and an outcome of pandemic prevention, preparedness and response” stressed Dr Viviana Munoz Tellez of the South Centre, an intergovernmental organization based in Geneva that helps developing countries promote their common interests in the international arena. Munoz Tellez noted the deep inequalities between member states, also exacerbated by profit-driven medical and pharmaceutical services – which the poor can often not afford. Parts of the draft treaty text are already facing strong private sector opposition for clauses that some see as impinging too much on market forces, or threatening patent protections on drugs and treatment. For instance, one of the clauses of the ‘zero-draft’ of the treaty proposes that 20% of pandemic-related products, such as vaccines or equipment, should be allocated to WHO or other global health partners, which will then ensure equal distribution among member states. “It is a global problem that we have – a number of countries that are not able to meet even basic capacities for pandemic prevention, and that response to the COVID pandemic, we saw, was highly inequitable,” Munoz Tellez told the subcommittee’s hearing. “In that sense, there has been this drive to say that part of the response for future pandemics is to have equity at the center. “Private sector had the upper hand as we’ve generally seen overall in the R&D system right now. So we think this is also a very important opportunity for the pandemic treaty to improve the global system from research and development that responds better to public health needs, not just profit incentives.” Despite the many challenges remaining, Ullmann is hopeful that all parties will be willing to compromise and “contribute to a just and efficacious global health policy.” “Failing cannot be an option as the next pandemic can be just around the corner, and no single government or institution can address this threat by itself,” the German lawmaker added in an email to Health Policy Watch, just after the briefing ended. “For sure, it is imperative to break the cycle of panic and neglect once and for all.” Global Action Against Uganda’s Anti-Homosexuality Bill Amid Surge of Violent Attacks 25/04/2023 Kerry Cullinan Protestors in Washington DC. Protestors gathered outside Ugandan embassies worldwide on Tuesday for a global day of action against that country’s Anti-Homosexuality Bill, which criminalises all LGBTQ people and proposes a series of punishments ranging from fines to the death penalty. Violence against people suspected of being LGBTQ has already surged in the past month since Uganda’s Parliament passed the Bill with almost unanimous support. However, Ugandan President Yoweri Museveni declined last week to sign the Bill into law, sending it back to parliament last week with the instruction that it be “reinforced and strengthened”. While Museveni also congratulated MPs for rejecting “the pressure from imperialists”, he has been under intense pressure from the United Nations, US and European Union members not to sign the Bill. In addition, Uganda’s Deputy Attorney General has written to the Speaker highlighting why the Bill is unconstitutional, particularly focusing on the death penalty clauses. SOUND ON 🔊: President @KagutaMuseveni speaks about the Anti-Homosexuality Bill. pic.twitter.com/aXvU0YCplN — State House Uganda (@StateHouseUg) April 24, 2023 Since the Bill was passed a month ago, hate crimes and violence against LGBTQ people have risen sharply, according to the Human Rights and Awareness and Promotion Forum (HRAPF), a legal aid organisation. HIV services have also been affected, with some LGBTQ patients being afraid to attend clinics for fear of being arrested, according to The Lancet. In the past month, HRAPF has handled 59 cases involving LGBTQ or suspected LGBTQ persons. Forty of these cases “involved violence and violations targeting the victims purely on the basis of their presumed sexuality, and affected a total of 85 persons”. There is an exponential increase in cases of violence and violations against LGBTI persons fueled by the politicisation around the Anti Homosexuality Bill 2023 Read HRAPF’s report here>>> https://t.co/2Gre5T01Uh pic.twitter.com/lWSIQxNkcZ — HRAPF (@hrapf_uganda) April 24, 2023 “In one of these cases, a group of six people were arrested and charged with having carnal knowledge against the order of nature because the area local chairperson saw a video from a gay porn site in which one of the actors looked like one of the victims,” according to HRAPF, which itself faces fines simply for assisting LGBTQ clients. “In the most recent case, an athlete who was suspected to be a transgender woman was arrested by a mob, forcefully undressed and then forced to march through the streets naked while the crowd heckled her, threw objects at her, took her photos/ videos and even fondled her.” Meanwhile, a report released on Monday points out that Western governments and aid agencies – including the UK, Dutch, Norwegian and US governments – have donated $40 million to Ugandan anti-LGBTQ religious groups such as the Inter-Religious Council of Uganda since 2014. While the report acknowledges that there is no evidence “that any of this money specifically paid for anti-LGBTQI activities”, it adds that the aid and partnerships “can boost groups’ credibility, their reputations, and their access to power and other finance”. Kenya follows Uganda A Kenyan Member of Parliament, Peter Kaluma, has tabled an almost identical Bill to his parliament shortly after returning from a meeting in Uganda where leaders of a US anti-LGBTQ group, Family Watch International (FWI), delivered keynote addresses. FWI has a long history of involvement in anti-LGBTQ activities in Africa and was involved in promoting the forerunner of the current Uganda Bill, the so-called “kill the gays” Bill passed in 2014 but stopped by the courts on a technicality. FWI founder and leader Sharon Slater has doggedly pursued an anti-LGBT agenda for years, making a wide variety of claims including that LGBT people are more likely to be paedophiles. Slater, has also played a hand in the extreme anti-LGBTQ Bill before Ghana’s parliament. I recently had the honor of meeting with Ms. Sharon Slater, President of Family Watch International, & her team. They attended the first African Regional Inter-Parliamentary Conference in Uganda, focusing on global challenges that threaten African families & values. pic.twitter.com/8RP8ba4sLJ — Janet K Museveni (@JanetMuseveni) April 4, 2023 Slater, a Mormon from Arizona, has also been campaigning for years for African governments to ban comprehensive sexuality education in schools. A proponent of “conversion therapy”, a discredited approach that aims to change a person’s sexuality, Slater has apparently convinced Museveni that such ‘therapy’ should be promoted in the Bill to encourage people to renounce their homosexuality. Family Watch International’s Sharon Slater addresing Ugandan politicians Geopolitical complications While the Anti-Homosexuality Bill has drawn condemnation from European governments and the US, this has been muted as Western governments are in a race to woo African governments away from Russia and China. Russia also persecutes LGBTQ people and has a similar anti-rights agenda as Uganda. Meanwhile, South Africa, which outlaws discrimination against citizens on the basis of sexual orientation, is the only African country to mount protests against the Bill. The opposition Economic Freedom Fighters, which has significant youth support, has marched to the Ugandan Embassy in Pretoria. Meanwhile, on Tuesday the Secretary General of the ruling African National Congress said that discrimination and persecution were against the African Charter, and called on all states to “ensure that their citizens enjoy their full human rights”. Trump Politicisation of COVID Was a ‘Comorbidity’ in Disappointing US Pandemic Response 25/04/2023 Megha Kaveri President Donald Trump listens as Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, speaks to the press in 2020. An expert investigation into the US response to the COVID-19 pandemic has concluded that the country’s performance was the most disappointing in the world. The investigation’s report was launched on Tuesday as a book, Lessons from the COVID War, providing an in-depth analysis of America’s response to the pandemic and the aftermath by the COVID Crisis Group, an independent group of experts. No country’s performance in dealing with the pandemic was more disappointing than that of the US, according to the group. They came to this conclusion as the US excess deaths during the pandemic were around 40% higher than that of Europe, despite the US possessing deeper scientific knowledge about the virus and spending trillions of dollars to address it. Donald Trump’s politicking during the start of the pandemic when he was president is heavily criticised, with the authors concluding that his politicisation of the pandemic was a “comorbidity”. The book also examines the race to develop an effective vaccine against COVID-19 (Operation Warp Speed), COVID origins and the policies adopted by the federal and state governments. The COVID Crisis Group was born in 2021 out of a need to analyse the country’s COVID-19 response given that the pandemic killed more Americans than all US wars combined since the US War of Independence. The group consisted of 34 members – physicians, public health and policy experts led by Philp Zelikow, who led the official commission that looked into the 9/11 attacks. Lab-leak theory The report examines both the lab leak theory and the animal-human transmission theory of COVID-19, but doesn’t support either of these due to lack of sufficient evidence in both cases. The origins of COVID-19 has been a controversial topic as some believe that the virus might have broken out into the general population from the high-security laboratory that conducts research on coronaviruses at the Wuhan Institute of Virology in China. However, this theory has been disputed by many other eminent scientists and the World Health Organization (WHO), who believe that COVID-19 might have originated from a spillover event at a wet market in Wuhan province. The book comes down heavily on the US Centers for Disease Prevention and Control (CDC) and says that the agency took on a reactive role in a pandemic instead of proactively leading the way. Elaborating on the activities that went behind the development of successful mRNA vaccines against COVID, the book says that both Pfizer and Moderna enjoyed tremendous support from the federal government, either through upfront investment into development or as advance purchase guarantees that ran to billions of US dollars. It also emphasises how “Operation Warp Speed”, as it was known then, was a success only because of a perfect alignment of many other factors around it. Image Credits: flickr/The White House. Official White House Photo by Andrea Hanks. Africa to Manufacture New Malaria Vaccine? 24/04/2023 Paul Adepoju A healthcare worker gives a child a dose of the world’s first malaria vaccine, RTS,S. A second malaria vaccine has now been approved. IBADAN, Nigeria – There are high hopes that the R21/Matrix-M malaria vaccine recently approved by Ghana and Nigeria will be manufactured in Africa in the not-to-distant future – a brighter-than-usual prospect for this World Malaria Day (25 April). Earlier this month, Ghana’s Food and Drugs Authority (FDA) approved the R21/Matrix-M malaria vaccine manufactured by the Serum Institute of India (SII) for use in children aged from five months to three years, the age group at the highest risk of death from malaria. This was despite the vaccine not yet being given World Health Organization (WHO) prequalification approval. SII, the manufacturing and commercialisation license holder for the vaccine, described Ghana’s approval as the “first crucial step [that] will enable the vaccine to help Ghanaian and African children to effectively combat malaria”. “The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives,” said Adar Poonawalla, SII CEO. Shortly afterwards, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) also granted a “registration approval” for the vaccine to SII. The agency said it had received the dossier of the vaccine and it had been subjected to independent review at two levels. The agency added that the vaccine’s dossier substantially complied with best international standards, and that its Joint Review Committee had concluded the vaccine data was robust and met the criteria for efficacy, safety, and quality. Local production? Ghana’s regulator announced that the application for regulatory approval had been submitted by SII’s ‘local agent’, DEK, which expects to eventually manufacture the vaccine locally. “The status of the [Ghana] FDA Lab creates a great advantage for the local agent who hopefully will be manufacturing the malaria vaccine in Ghana in the near future,” the agency stated. A few days after the regulatory approval, a ground-breaking ceremony of the DEK Vaccines Limited’s vaccine fill-and-finish plant was held. The company is a private sector-led consortium of Ghanaian pharmaceutical companies. At the ceremony, Ghanaian President Nana Addo Dankwa Akufo-Addo, said it “will help our nation realise the dream of becoming self-sufficient in the manufacture of vaccines”. Meanwhile, Nigeria’s regulator announced Fidson Healthcare Ltd, a major local bourse-listed player in the country’s pharmaceutical industry, as the vaccine’s Marketing Authorization Holder (MAH). This authorizes the Nigerian firm licensed to distribute, sell and commercialize the vaccine in Nigeria. The Nigerian government also revealed in September 2022 that it had signed a local vaccine manufacturing agreement involving Biovaccines Nigeria Limited (a joint venture between the Federal Government of Nigeria and May & Baker Nigeria Plc), and SII. “The government has approved 15% of the vaccines that UNICEF normally supplies to Biovaccines to supply through contract manufacturing with the Serum Institute of India. With that, the institute will now be comfortable enough to come and join Biovaccines Nigeria in building its manufacturing plant here in Nigeria in Ota,” Nigerian health minister, Osagie Ehanire said. From Oxford to West Africa via India An infant receiving the RTS,S malaria vaccine in Ghana in 2019. Designed and developed at the University of Oxford, the vaccine has been tested in the United Kingdom, Thailand, and several African countries. A Phase Three trial that is underway in Burkina Faso, Kenya, Mali and Tanzania has enrolled 4,800 children and the results are expected later this year. While the regulator in Nigeria has also recommended an in-country Phase Four clinical trial or pharmacovigilance study in the implementation, given the peculiarity and heterogeneous nature of malaria in Nigeria, it noted that the efficacy results from the vaccine’s clinical trials contributed to its decision to approve it. Last year, the Oxford researchers and their partners reported from a Phase 2B trial that a booster dose of R21/Matrix-M at one year, following a primary three-dose regime, maintained high efficacy against malaria, and continued to meet the WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. This followed 2021 results from the Phase 2B trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77%. Recent data from the large phase III trial also show high levels of efficacy and a reassuring safety profile. Prof Adrian Hill, chief investigator for R21/Matrix-M programme, and Director of the Jenner Institute at the University of Oxford, described the regulatory approval of the vaccine as the culmination of 30 years of malaria vaccine research at Oxford. “I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children,” Hill said. The vaccine contains Novavax’s Matrix-M which is a saponin-based adjuvant that enhances the immune system response, making it more potent and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This technology has also been used successfully in Novavax’s COVID-19 vaccine and is a key component of other development-stage vaccines. An approval without a WHO prequalification Unlike the developments surrounding the approval of the COVID-19 vaccines in the African countries that largely followed a prequalification approval by the WHO, both Ghana and Nigerian regulators went ahead to approve the vaccine without any WHO approval. In addition to affirming their regulators’ competence and authorization to undertake such approvals, Dr Franklin Asiedu–Bekoe, Director of Public Health in Ghana, told Health Policy Watch that the vaccine – the second malaria vaccine that the country is rolling out – will be closely reviewed by the country’s team of scientists. “In Ghana, we have 93 districts that are now using the TRS,S. There are a number of districts that are yet to be using it. So if we have a vaccine, which is good, I think nothing stops us from using it,” he argued. Moreover, Prof William K. Ampofo, Secretary of the Presidential Committee on Vaccine Manufacturing and Development, Ghana, added that the approval was in response to the manufacturer’s application. “The vaccine was approved based on the application by the manufacturer Serum Institute. It was not an independent decision by the Ghana FDA. It was in response to the application by the Serum Institute for the R21 vaccine based on the data that had been accumulated,” Ampofo told Health Policy Watch. Local manufacturing elements of both approvals In the weeks before regulatory approval for the R21 vaccine, Ghana officially expanded access to the WHO-approved RTS,S malaria vaccine. Four years on, more than 4.5 million doses of the vaccine have been administered through the countries’ routine immunization programmes. “Community demand for the vaccine is high and the vaccine is well accepted in African communities, even when additional visits to vaccination clinics are required to receive the four-dose schedule,” WHO revealed. But RTS,S rollout has been plagued with concerns regarding its comparatively minimal efficacy, high cost and limited supply. In sharp contrast, R21’s demonstrably higher efficacy (more than 75% over 12 months) and comparatively lower cost ($3 compared with RTS,S’ $5 per dose) made it even more attractive to African countries – along with the manufacturer’s announcement of potential manufacturing capacities of more than 200 million doses annually. But beyond these essential factors are also considerations for local manufacturing from the outset of the vaccine’s introduction in Africa. WHO and Gavi falling in line Even though the WHO prequalification certification has not yet approved the R21 vaccine, the WHO has expressed its support for the vaccine, acknowledging on its website that a second malaria vaccine may be coming forward. “The WHO prequalification process is also underway. WHO will continue the thorough and efficient review of the R21 vaccine and awaits the submission of additional analyses by the vaccine developer,” the global health body said. Dr Phionah Atuhebwe, New Vaccines Introduction Officer at WHO AFRO Regional Office, added that the WHO is already evaluating the vaccine’s safety, efficacy, quality and programmatic suitability. “Ghana and Nigeria have not jumped the gun because it is expected that, at national level within their jurisdiction, the national regulatory authorities can also review data once they have received information from different vaccine developers,” she said. Gavi’s Aurelia Nguyen Aurelia Nguyen, Chief Programme and Strategy Officer for Gavi, the Vaccine Alliance, also told Health Policy Watch that the alliance is prepared to provide funding for the R21 malaria vaccine. “It is a hugely exciting development with the approvals that we’ve seen in Ghana and Nigeria. This is all moving us forward towards having a second vaccine,” Nguyen said. She noted that the restricted supply of the RTS,S made it “really important” to have several tools, in addition to affordability. “It’s not just about the volumes, it’s also about the affordability. Serum Institute has made a very important public commitment in terms of keeping the cost of the vaccines to $3 or less. So we really look forward to them honoring that commitment because ultimately, it will mean that more people are protected,” Nguyen concluded. Image Credits: WHO/Fanjan Combrink, WHO/M. Nieuwenhof, WHO. Powerful Partnership to Address Backslide in Childhood Vaccinations – But No Extra Funds 24/04/2023 Stefan Anderson “No child should die of a vaccine-preventable disease,” said WHO Director-General Tedros Adhanom Ghebreyesus. The world’s largest global health organizations have announced a partnership to reverse the years-long backslide in global childhood vaccination rates caused by the COVID-19 pandemic. An estimated 67 million children missed at least one essential vaccination between 2019 and 2021 and 50 million of these didn’t receive any vaccines – setting back childhood vaccination rates to their lowest level since 2008. But the “Big Catch-Up”, billed as an “extended effort” to restore vaccination levels in children to at least pre-pandemic levels and shore up essential health services for immunization programmes, does not contain any new financial commitments. Participants include the World Health Organization (WHO), UNICEF, the vaccine alliance Gavi, the Bill & Melinda Gates Foundation and a number of national and global health organizations. In the past three years, the overburdening and disruption of health services by COVID-19 containment efforts eroded over a decade of gains in routine childhood immunization levels. The vaccination schedules of millions of children around the world were knocked-off course, exposing them to life-threatening viruses that can be prevented by existing vaccines. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters the “Big Catch-Up” partnership does not involve any new financial commitments to bolster global childhood vaccination efforts. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters on Monday that preliminary estimates indicate that the backslide in childhood vaccinations has led to “at least” a five percent increase in mortality among children. “Every one of these lives that are lost is on top of the mortality that already exists because of the imperfection of the coverage and immunization programmes,” O’Brien said. “There will continue to be these children who are at risk going forward unless they are caught up.” Over 100 countries recorded declines in childhood vaccination rates during the pandemic, but three-quarters of the 25 million children who missed vaccinations in 2021 live in just 20 low- and middle-income countries. These will be a “particular focus” for the global coalition. “Millions of children and adolescents, particularly in lower-income countries, have missed out on life-saving vaccinations, while outbreaks of these deadly [preventable] diseases have risen,” said WHO director-general Tedros Adhanom Ghebreyesus. “Catching up is a top priority. No child should die of a vaccine-preventable disease.” Inequality is still behind vaccine access When UNICEF first began tracking childhood vaccination rates in 1980, just one in 10 children in the world’s poorest countries would “ever see a trained health worker or be immunized” before their first birthday. By the start of the next decade, seven in 10 children around the world were protected by vaccines – rising steadily to a height of 86% in 2019. Despite decades of progress, the story of children not receiving essential childhood vaccines remains one of inequality and poverty. One in five children in the world’s poorest households today are ‘zero-dose’, meaning they have never received a vaccine of any kind, according to UNICEF’s 2023 State of the World’s Children report released last week. In West and Central Africa, that number rises to nearly one in two, compared to one in 20 in the wealthiest countries. “Routine vaccines are typically a child’s first entry into their health system and so children who miss out on their early vaccines are at added risk of being cut out of healthcare in the long run,” UNICEF executive director Catherine Russel said. “The longer we wait to reach and vaccinate these children, the more vulnerable they become and the greater the risk of more deadly disease outbreaks.” Asked about the role of vaccine scepticism in dropping child vaccination rates, O’Brien stressed that while the global proliferation of misinformation around vaccines is “deeply concerning” – UNICEF found vaccine confidence dropped in 52 out of 55 countries – it remains a minor factor compared to income. “The main reason that kids are unvaccinated is not anti-vax [beliefs],” O’Brien said. “The main reason why children are unvaccinated has to do with access to services, quality of services, and the full availability of programmes.” Big ambitions, no extra funding No new funding to support the goal of returning childhood vaccination rates to pre-pandemic levels is included as part of the “Big Catch-Up”. “We’ve done an assessment of the resources that are out there, and we do feel that the resources are there,” O’Brien. “There are substantial resources already in-country and still available to countries through many different mechanisms.” Meanwhile, Medecins sans Frontieres (MSF) highlighted that children in conflict zones were particularly affected. “Despite the progress made in expanding global vaccination coverage, nearly 11 million of the un- and under-vaccinated infants live in fragile or humanitarian settings, including countries affected by conflict, and remain the most vulnerable to disease outbreaks,” said Dr Sharmila Shetty, Vaccines Medical Advisor for MSF’s Access Campaign. Africa’s burden According to estimates by WHO and UNICEF, the number of zero-dose and under-immunized African children rose by 16% between 2019 and 2021 to a cumulative total of about 33 million, nearly half the global figure. At a WHO AFRO press briefing last Thursday, Gavi, The Vaccine Alliance, revealed it is working in Sierra Leone and Ghana to ensure that the millions of children and adolescent girls who missed out on vaccines during the pandemic are protected. “We’re very, very happy to be marking in a few days, the 2023 edition of the Africa Vaccination Week, and it’s a really good opportunity for us to take stock and to remind ourselves of what we have achieved but also what we are dealing with in terms of recovering from a pretty unprecedented emergency during the pandemic,” said Aurelia Nguyen, Gavi’s Chief Programme and Strategy Officer. Nguyen said that Gavi is working closely with its partners to support countries in making up lost ground and building stronger, more resilient systems. The efforts will focus on on hard-to-reach communities and implementing national programmes that are able to reach children and communities more effectively. Gavi is also focusing on the human papillomavirus (HPV) vaccine program, which was one of the hardest hit during the pandemic. With cervical cancer being the most common cause of cancer death in nearly half of sub-Saharan African countries, Nguyen noted that the HPV vaccine can prevent up to 90% of cervical cancer cases. So far, Gavi said it has supported 20 African countries to produce the HPV vaccine and received $600 million in extra investment last year to revitalize the program and strengthen health systems. “As we think about many, many challenges ahead, we also are considering the opportunities and we have a young and growing population, and so it’s really our responsibility and opportunity to make sure that we don’t leave any child behind with immunization,” said Nguyen. Additional reporting by Paul Adepoju. Image Credits: WHO / Billy Miaron. 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. 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WHO has Terminated Eight Staffers’ Contracts for Sexual Misconduct in Past Seven Months 26/04/2023 Megha Kaveri Dr Gaya Gamhewage, Director, Prevention of Sexual Misconduct, WHO. Four World Health Organization (WHO) staff or consultants had their contracts terminated as a result of sexual misconduct allegations in the last quarter of 2022 – the most of any year so far. The contracts of another three people had already been terminated between January and March of this year, Dr Gaya Gamhewage, WHO’s Director of Prevention and Response to Sexual misconduct, told the media on Wednesday. The revelations came on the heels of news on Monday that WHO had dismissed senior manager Temo Waqanivalu following the conclusion of a high-profile investigation of sexual misconduct charges, first brought by a British doctor who had attended the World Health Summit last October in Berlin. “In the last year, our investigation team acted on not just the cases that were highlighted in the media, but have completed 120 investigations into sexual misconduct,” Gamhewage said in the briefing, adding that “72 other investigations are ongoing.” Gamhewage’s report was the most complete, in terms of numbers to date, of WHO actions since the agency WHO undertook a major revamp of its programmes for preventing and responding to allegations of sexual misconduct – including a major expansion of its investigations team. WHO overhaul came in wake of DRC sex scandal The WHO overhaul came in the wake of media revelations of widespread sexual exploitation, abuse and harassment, including cases of rape, by dozens of WHO and other UN responders to the 2018-2020 Ebola outbreak. In 2021, after a scathing report by a WHO-mandated Independent Commission investigation pointing to major shortcomings in the agency’s SEAH management, WHO announced worldwide reforms in both its investigative and prevention policies. However while the Independent Commission report also called for “disciplinary sanctions” against the alleged DRC perpetrators found culpable, Gamhewage’s report on Wednesday did not include the outcomes of their cases. That’s because the UN’s Office of Internal Oversight Services (UN OIOS) – and not WHO – are managing those cases separately and have yet to deliver their final reports, she said. “We are not investigating the DRC cases. They are all with UN OIS,” Gamhewage told Health Policy Watch in response to a follow-up question. “We can only take action once we receive their reports.” WHO changed ‘how we work, our structures, our culture’ But she asserted that WHO’s overhaul of its own internal systems was significant. “WHO started changing how we work, our structures, our culture, our processes over the last 18 months,” she said. “Because of the many changes we’ve made..having much stronger investigations capacity that is benchmarked, that’s fast and fair…providing better victim support …are having a cumulative effect that is changing our organization.” While acknowledging the role played by the media in breaking some of the taboos around addressing sexual misconduct, Gamhewage insisted that WHO also is “making changes with or without media spotlight.” And she issued a warning to media who have been covering the trail of sexual misconduct cases at the organisation saying that some stories risked violating the rights of victims and alleged perpetrators. “I want to caution that the media spotlight should not harm the due process that is owed to everybody involved,” she said, referring to the right of confidentiality of both victims and survivors. “It’s only when we protect these things will the disciplinary action that we take a stand. Otherwise, it can be appealed and nobody will win,” she said. Her remarks were echoed by WHO Director-General Dr Tedros Adhanom Ghebreyesus who added: “On the one hand, media helps; it’s the eyes and ears of the so keep doing that, we appreciate your work. On the other hand, I would like to stress that …. we see a lack of balance. In some of the reporting [there are] factual errors. And when we try to correct … there is refusal from some of the media outlets even to correct the factual errors.” “So we believe that you are helping us, but at the same time, I would urge you to… really make journalism balanced. And any factual issue you bring, we will take it seriously,” he promised. European Commission Finally Releases Pharma Law Reforms, Proposing Cuts to Market Exclusivity for New Drugs 26/04/2023 Kerry Cullinan EU Health Commissioner Stella Kyriakides Long-anticipated European Commission proposals to reform the European Union’s pharmaceutical legislation – the biggest shake-up in 20 years – were finally made public on Wednesday. The reforms are aimed particularly at addressing access and price disparities between European states, ensuring that all EU citizens have access to the same products at the same price, EU Health Commissioner Stella Kyriakides told a media briefing. “We are putting forward proposals to ensure that medicines reach patients everywhere in Europe, in a timely and equitable fashion,” said Kyriakides. Aside from high prices and medicine shortages, the Commission is particularly concerned about “unmet medical needs, rare diseases and antimicrobial resistance (AMR)”. The proposals have six policy objectives, namely to: create a single market for medicines, thus ensuring that all patients across the EU have “timely and equitable access to safe, effective, and affordable medicines”; offer “an attractive and innovation-friendly framework” for research, development, and production of medicines in Europe; speed up procedures significantly, particularly by reducing authorisation times for medicines to 180 days, so they reach patients faster; enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU; address antimicrobial resistance (AMR) and pharmaceuticals in the environment through a One Health approach; Make medicines more environmentally sustainable. We want medicine to be more accessible, available, and affordable. Our #EUPharmaStrategy legislative reform proposes a single market of medicines that: 🔸 is patient-centric🔹 fosters innovation🔸 fights antimicrobial resistance🔹 is environmentally friendly ↓#HealthUnion — European Commission (@EU_Commission) April 26, 2023 One of its proposals involves cutting drug market exclusivity for new medicines from 10 to eight years, after which the market will be opened to generics. However, drug companies that launch new medicines in all 27 EU member states within two years of development will still be able to get the extra two years’ exclusivity. In addition, manufacturers producing treatments for “unmet medical needs” will get an extra six months of protection. As an incentive to manufacturers to develop new antibiotics, the EC proposes “transferable exclusivity vouchers (TEVs)” for drug companies that give a year of protection to any of the company’s medicines. The proposals also envisage the EU being able to set up manufacturing of vaccines and drugs using compulsory licenses during public health emergencies. Positive precedent, says MSF Dimitri Eynikel, EU Policy Advisor for Médecins Sans Frontières (MSF) Access Campaign, said that “with some tweaks”, the reforms “could set a positive precedent towards enshrining access to medicines provisions in law”. “We applaud the proposal’s bid for greater transparency: obliging companies to open their books on all direct public funding received for the research and development of medicines is a critical step to ensure that medicines are priced appropriately and affordably for the people who need them,” said Eynikel. “In addition, plans for granting more effective compulsory licenses by suspending data and market exclusivity would be historic, and should encourage other countries and regions to adopt similar measures to secure the availability of affordable medicines.” But MSF is against the introduction of vouchers to encourage the development of new antimicrobials, warning that this could “prolong pharmaceutical monopolies, undermine generic competition and severely slow down people’s access to new and affordable medicines”. Pharma unhappy However, the reaction from pharmaceutical companies has been less positive. The European Federation of Pharmaceutical Industries and Associations (EFPIA) says that the proposals will “undermine research and development in Europe while failing to address access to medicines for patients.” EFPIA Director General Nathalie Moll laid the blame for slow access to medicines at the door of different systems in EU member states: “Fixing the tenfold variation in access to new medicines across the EU, requires all partners to urgently get round the table and address the real issues rather than unworkable EU-level legislation that is destined to fail.” “Although the revised legislation was meant to improve Europe’s competitiveness, the ‘net’ impact of policies set out across these proposals, in their current form, puts European competitiveness at risk,’ said EFPIA president Hubertus von Baumbach. Meanwhile, GSK Chief Executive Emma Walmsley told Reuters that weakening market exclusivity protections “could discourage companies from researching and launching treatments in Europe”. Process The European Parliament still has to pass the proposals, which means that there are still a number of opportunities for the proposals to be tweaked or changed. However, MSF’s Eynikel appealed to EU member states and the European Parliament not to water down the provisions on transparency and compulsory licenses. World Needs Ambitious Pandemic Accord – ‘Failing is Not an Option’ says German MP 26/04/2023 Alex Winston German MP Andrew Ullmann Many challenges remain in negotiating an international pandemic treaty, experts tell a committee of the German Parliament. As COVID-19 cases decline, multilateral polarization and a weary public leaves countries at risk should another global pandemic strike, German MP Andrew Ullmann stated on Monday at the German Parliament (Bundestag). The Bundestag’s Global Health Subcommittee held a technical briefing on the international pandemic accord currently being negotiated by World Health Organization (WHO) member states to ensure better global pandemic prevention, preparedness and response. “It is imperative to complete reforms to address the gaps in international health crises management,” Ullmann said. “We need to strive for an ambitious pandemic agreement. But, of course, this is easier said than done since interests between countries show a strong divide.” The pandemic accord aims to address areas currently not covered by the International Health Regulations (IHR) – the gobal laws to prevent the international spread of disease – and improve the international community’s ability to prevent and respond to pandemics in a just and effective manner. “There were huge gaps in the COVID-19 response, and there are three key objectives. First, one must be better prepared – from the community to the country, to the regional to the global level. Two, to have a better chance at preventing future pandemics, and three, to have a better and more coordinated response, and that is the aim,” Steven Solomon, WHO’s Principal Legal Officer, told the hearing. Steven Solomon, WHO Principal Legal Officer According to the process agreed in December 2021 by governments at a special session of the World Health Assembly, the WHO’s highest decision-making body, an intergovernmental negotiating body (INB) will aim to produce a final draft of the pandemic accord for consideration by the 77th World Health Assembly in 2024. Dr Clare Wenham, Associate Professor of Global Health Policy at the London School of Economics, told the hearing that the International Health Regulations were binding on member states but required maintaining a balance between “protecting against the international spread of disease and doing so in ways which are commensurate with the risk to international travel and trade, but it’s not a panacea.” Dr Clare Wenham Pointing out several other challenges surrounding the agreement and implementation of an international treaty, Wenham noted that “there have been challenges within the IHR around data sharing and whether there is free flowing and timely information being shared between countries and WHO.” China, in particular, has come under heavy scrutiny and criticism for its perceived refusal to share information or data on COVID-19. WHO is a member-state agency but has no physical compliance mechanism to enforce its member states to implement regulations other than, as Wenham pointed out, “name and shame mechanisms.” “There are challenges with financing and cooperation issues, so governments of higher income countries are supposed to support and assist and collaborate with low-income countries to be able to improve their capacities to respond to a pandemic,” Wenham said. “Also, other governance issues have come up during the pandemic of COVID, such as a lack of consideration of secondary impacts or pandemic policy.” Secondary impacts include such things as the effect of lockdowns on people’s physical and mental health and the financial implications that saw businesses affected worldwide. Zero draft The ‘zero draft’ of the accord, released in 2023, states that “all lives have equal value, and that therefore equity should be a principle, an indicator and an outcome of pandemic prevention, preparedness and response” stressed Dr Viviana Munoz Tellez of the South Centre, an intergovernmental organization based in Geneva that helps developing countries promote their common interests in the international arena. Munoz Tellez noted the deep inequalities between member states, also exacerbated by profit-driven medical and pharmaceutical services – which the poor can often not afford. Parts of the draft treaty text are already facing strong private sector opposition for clauses that some see as impinging too much on market forces, or threatening patent protections on drugs and treatment. For instance, one of the clauses of the ‘zero-draft’ of the treaty proposes that 20% of pandemic-related products, such as vaccines or equipment, should be allocated to WHO or other global health partners, which will then ensure equal distribution among member states. “It is a global problem that we have – a number of countries that are not able to meet even basic capacities for pandemic prevention, and that response to the COVID pandemic, we saw, was highly inequitable,” Munoz Tellez told the subcommittee’s hearing. “In that sense, there has been this drive to say that part of the response for future pandemics is to have equity at the center. “Private sector had the upper hand as we’ve generally seen overall in the R&D system right now. So we think this is also a very important opportunity for the pandemic treaty to improve the global system from research and development that responds better to public health needs, not just profit incentives.” Despite the many challenges remaining, Ullmann is hopeful that all parties will be willing to compromise and “contribute to a just and efficacious global health policy.” “Failing cannot be an option as the next pandemic can be just around the corner, and no single government or institution can address this threat by itself,” the German lawmaker added in an email to Health Policy Watch, just after the briefing ended. “For sure, it is imperative to break the cycle of panic and neglect once and for all.” Global Action Against Uganda’s Anti-Homosexuality Bill Amid Surge of Violent Attacks 25/04/2023 Kerry Cullinan Protestors in Washington DC. Protestors gathered outside Ugandan embassies worldwide on Tuesday for a global day of action against that country’s Anti-Homosexuality Bill, which criminalises all LGBTQ people and proposes a series of punishments ranging from fines to the death penalty. Violence against people suspected of being LGBTQ has already surged in the past month since Uganda’s Parliament passed the Bill with almost unanimous support. However, Ugandan President Yoweri Museveni declined last week to sign the Bill into law, sending it back to parliament last week with the instruction that it be “reinforced and strengthened”. While Museveni also congratulated MPs for rejecting “the pressure from imperialists”, he has been under intense pressure from the United Nations, US and European Union members not to sign the Bill. In addition, Uganda’s Deputy Attorney General has written to the Speaker highlighting why the Bill is unconstitutional, particularly focusing on the death penalty clauses. SOUND ON 🔊: President @KagutaMuseveni speaks about the Anti-Homosexuality Bill. pic.twitter.com/aXvU0YCplN — State House Uganda (@StateHouseUg) April 24, 2023 Since the Bill was passed a month ago, hate crimes and violence against LGBTQ people have risen sharply, according to the Human Rights and Awareness and Promotion Forum (HRAPF), a legal aid organisation. HIV services have also been affected, with some LGBTQ patients being afraid to attend clinics for fear of being arrested, according to The Lancet. In the past month, HRAPF has handled 59 cases involving LGBTQ or suspected LGBTQ persons. Forty of these cases “involved violence and violations targeting the victims purely on the basis of their presumed sexuality, and affected a total of 85 persons”. There is an exponential increase in cases of violence and violations against LGBTI persons fueled by the politicisation around the Anti Homosexuality Bill 2023 Read HRAPF’s report here>>> https://t.co/2Gre5T01Uh pic.twitter.com/lWSIQxNkcZ — HRAPF (@hrapf_uganda) April 24, 2023 “In one of these cases, a group of six people were arrested and charged with having carnal knowledge against the order of nature because the area local chairperson saw a video from a gay porn site in which one of the actors looked like one of the victims,” according to HRAPF, which itself faces fines simply for assisting LGBTQ clients. “In the most recent case, an athlete who was suspected to be a transgender woman was arrested by a mob, forcefully undressed and then forced to march through the streets naked while the crowd heckled her, threw objects at her, took her photos/ videos and even fondled her.” Meanwhile, a report released on Monday points out that Western governments and aid agencies – including the UK, Dutch, Norwegian and US governments – have donated $40 million to Ugandan anti-LGBTQ religious groups such as the Inter-Religious Council of Uganda since 2014. While the report acknowledges that there is no evidence “that any of this money specifically paid for anti-LGBTQI activities”, it adds that the aid and partnerships “can boost groups’ credibility, their reputations, and their access to power and other finance”. Kenya follows Uganda A Kenyan Member of Parliament, Peter Kaluma, has tabled an almost identical Bill to his parliament shortly after returning from a meeting in Uganda where leaders of a US anti-LGBTQ group, Family Watch International (FWI), delivered keynote addresses. FWI has a long history of involvement in anti-LGBTQ activities in Africa and was involved in promoting the forerunner of the current Uganda Bill, the so-called “kill the gays” Bill passed in 2014 but stopped by the courts on a technicality. FWI founder and leader Sharon Slater has doggedly pursued an anti-LGBT agenda for years, making a wide variety of claims including that LGBT people are more likely to be paedophiles. Slater, has also played a hand in the extreme anti-LGBTQ Bill before Ghana’s parliament. I recently had the honor of meeting with Ms. Sharon Slater, President of Family Watch International, & her team. They attended the first African Regional Inter-Parliamentary Conference in Uganda, focusing on global challenges that threaten African families & values. pic.twitter.com/8RP8ba4sLJ — Janet K Museveni (@JanetMuseveni) April 4, 2023 Slater, a Mormon from Arizona, has also been campaigning for years for African governments to ban comprehensive sexuality education in schools. A proponent of “conversion therapy”, a discredited approach that aims to change a person’s sexuality, Slater has apparently convinced Museveni that such ‘therapy’ should be promoted in the Bill to encourage people to renounce their homosexuality. Family Watch International’s Sharon Slater addresing Ugandan politicians Geopolitical complications While the Anti-Homosexuality Bill has drawn condemnation from European governments and the US, this has been muted as Western governments are in a race to woo African governments away from Russia and China. Russia also persecutes LGBTQ people and has a similar anti-rights agenda as Uganda. Meanwhile, South Africa, which outlaws discrimination against citizens on the basis of sexual orientation, is the only African country to mount protests against the Bill. The opposition Economic Freedom Fighters, which has significant youth support, has marched to the Ugandan Embassy in Pretoria. Meanwhile, on Tuesday the Secretary General of the ruling African National Congress said that discrimination and persecution were against the African Charter, and called on all states to “ensure that their citizens enjoy their full human rights”. Trump Politicisation of COVID Was a ‘Comorbidity’ in Disappointing US Pandemic Response 25/04/2023 Megha Kaveri President Donald Trump listens as Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, speaks to the press in 2020. An expert investigation into the US response to the COVID-19 pandemic has concluded that the country’s performance was the most disappointing in the world. The investigation’s report was launched on Tuesday as a book, Lessons from the COVID War, providing an in-depth analysis of America’s response to the pandemic and the aftermath by the COVID Crisis Group, an independent group of experts. No country’s performance in dealing with the pandemic was more disappointing than that of the US, according to the group. They came to this conclusion as the US excess deaths during the pandemic were around 40% higher than that of Europe, despite the US possessing deeper scientific knowledge about the virus and spending trillions of dollars to address it. Donald Trump’s politicking during the start of the pandemic when he was president is heavily criticised, with the authors concluding that his politicisation of the pandemic was a “comorbidity”. The book also examines the race to develop an effective vaccine against COVID-19 (Operation Warp Speed), COVID origins and the policies adopted by the federal and state governments. The COVID Crisis Group was born in 2021 out of a need to analyse the country’s COVID-19 response given that the pandemic killed more Americans than all US wars combined since the US War of Independence. The group consisted of 34 members – physicians, public health and policy experts led by Philp Zelikow, who led the official commission that looked into the 9/11 attacks. Lab-leak theory The report examines both the lab leak theory and the animal-human transmission theory of COVID-19, but doesn’t support either of these due to lack of sufficient evidence in both cases. The origins of COVID-19 has been a controversial topic as some believe that the virus might have broken out into the general population from the high-security laboratory that conducts research on coronaviruses at the Wuhan Institute of Virology in China. However, this theory has been disputed by many other eminent scientists and the World Health Organization (WHO), who believe that COVID-19 might have originated from a spillover event at a wet market in Wuhan province. The book comes down heavily on the US Centers for Disease Prevention and Control (CDC) and says that the agency took on a reactive role in a pandemic instead of proactively leading the way. Elaborating on the activities that went behind the development of successful mRNA vaccines against COVID, the book says that both Pfizer and Moderna enjoyed tremendous support from the federal government, either through upfront investment into development or as advance purchase guarantees that ran to billions of US dollars. It also emphasises how “Operation Warp Speed”, as it was known then, was a success only because of a perfect alignment of many other factors around it. Image Credits: flickr/The White House. Official White House Photo by Andrea Hanks. Africa to Manufacture New Malaria Vaccine? 24/04/2023 Paul Adepoju A healthcare worker gives a child a dose of the world’s first malaria vaccine, RTS,S. A second malaria vaccine has now been approved. IBADAN, Nigeria – There are high hopes that the R21/Matrix-M malaria vaccine recently approved by Ghana and Nigeria will be manufactured in Africa in the not-to-distant future – a brighter-than-usual prospect for this World Malaria Day (25 April). Earlier this month, Ghana’s Food and Drugs Authority (FDA) approved the R21/Matrix-M malaria vaccine manufactured by the Serum Institute of India (SII) for use in children aged from five months to three years, the age group at the highest risk of death from malaria. This was despite the vaccine not yet being given World Health Organization (WHO) prequalification approval. SII, the manufacturing and commercialisation license holder for the vaccine, described Ghana’s approval as the “first crucial step [that] will enable the vaccine to help Ghanaian and African children to effectively combat malaria”. “The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives,” said Adar Poonawalla, SII CEO. Shortly afterwards, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) also granted a “registration approval” for the vaccine to SII. The agency said it had received the dossier of the vaccine and it had been subjected to independent review at two levels. The agency added that the vaccine’s dossier substantially complied with best international standards, and that its Joint Review Committee had concluded the vaccine data was robust and met the criteria for efficacy, safety, and quality. Local production? Ghana’s regulator announced that the application for regulatory approval had been submitted by SII’s ‘local agent’, DEK, which expects to eventually manufacture the vaccine locally. “The status of the [Ghana] FDA Lab creates a great advantage for the local agent who hopefully will be manufacturing the malaria vaccine in Ghana in the near future,” the agency stated. A few days after the regulatory approval, a ground-breaking ceremony of the DEK Vaccines Limited’s vaccine fill-and-finish plant was held. The company is a private sector-led consortium of Ghanaian pharmaceutical companies. At the ceremony, Ghanaian President Nana Addo Dankwa Akufo-Addo, said it “will help our nation realise the dream of becoming self-sufficient in the manufacture of vaccines”. Meanwhile, Nigeria’s regulator announced Fidson Healthcare Ltd, a major local bourse-listed player in the country’s pharmaceutical industry, as the vaccine’s Marketing Authorization Holder (MAH). This authorizes the Nigerian firm licensed to distribute, sell and commercialize the vaccine in Nigeria. The Nigerian government also revealed in September 2022 that it had signed a local vaccine manufacturing agreement involving Biovaccines Nigeria Limited (a joint venture between the Federal Government of Nigeria and May & Baker Nigeria Plc), and SII. “The government has approved 15% of the vaccines that UNICEF normally supplies to Biovaccines to supply through contract manufacturing with the Serum Institute of India. With that, the institute will now be comfortable enough to come and join Biovaccines Nigeria in building its manufacturing plant here in Nigeria in Ota,” Nigerian health minister, Osagie Ehanire said. From Oxford to West Africa via India An infant receiving the RTS,S malaria vaccine in Ghana in 2019. Designed and developed at the University of Oxford, the vaccine has been tested in the United Kingdom, Thailand, and several African countries. A Phase Three trial that is underway in Burkina Faso, Kenya, Mali and Tanzania has enrolled 4,800 children and the results are expected later this year. While the regulator in Nigeria has also recommended an in-country Phase Four clinical trial or pharmacovigilance study in the implementation, given the peculiarity and heterogeneous nature of malaria in Nigeria, it noted that the efficacy results from the vaccine’s clinical trials contributed to its decision to approve it. Last year, the Oxford researchers and their partners reported from a Phase 2B trial that a booster dose of R21/Matrix-M at one year, following a primary three-dose regime, maintained high efficacy against malaria, and continued to meet the WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. This followed 2021 results from the Phase 2B trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77%. Recent data from the large phase III trial also show high levels of efficacy and a reassuring safety profile. Prof Adrian Hill, chief investigator for R21/Matrix-M programme, and Director of the Jenner Institute at the University of Oxford, described the regulatory approval of the vaccine as the culmination of 30 years of malaria vaccine research at Oxford. “I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children,” Hill said. The vaccine contains Novavax’s Matrix-M which is a saponin-based adjuvant that enhances the immune system response, making it more potent and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This technology has also been used successfully in Novavax’s COVID-19 vaccine and is a key component of other development-stage vaccines. An approval without a WHO prequalification Unlike the developments surrounding the approval of the COVID-19 vaccines in the African countries that largely followed a prequalification approval by the WHO, both Ghana and Nigerian regulators went ahead to approve the vaccine without any WHO approval. In addition to affirming their regulators’ competence and authorization to undertake such approvals, Dr Franklin Asiedu–Bekoe, Director of Public Health in Ghana, told Health Policy Watch that the vaccine – the second malaria vaccine that the country is rolling out – will be closely reviewed by the country’s team of scientists. “In Ghana, we have 93 districts that are now using the TRS,S. There are a number of districts that are yet to be using it. So if we have a vaccine, which is good, I think nothing stops us from using it,” he argued. Moreover, Prof William K. Ampofo, Secretary of the Presidential Committee on Vaccine Manufacturing and Development, Ghana, added that the approval was in response to the manufacturer’s application. “The vaccine was approved based on the application by the manufacturer Serum Institute. It was not an independent decision by the Ghana FDA. It was in response to the application by the Serum Institute for the R21 vaccine based on the data that had been accumulated,” Ampofo told Health Policy Watch. Local manufacturing elements of both approvals In the weeks before regulatory approval for the R21 vaccine, Ghana officially expanded access to the WHO-approved RTS,S malaria vaccine. Four years on, more than 4.5 million doses of the vaccine have been administered through the countries’ routine immunization programmes. “Community demand for the vaccine is high and the vaccine is well accepted in African communities, even when additional visits to vaccination clinics are required to receive the four-dose schedule,” WHO revealed. But RTS,S rollout has been plagued with concerns regarding its comparatively minimal efficacy, high cost and limited supply. In sharp contrast, R21’s demonstrably higher efficacy (more than 75% over 12 months) and comparatively lower cost ($3 compared with RTS,S’ $5 per dose) made it even more attractive to African countries – along with the manufacturer’s announcement of potential manufacturing capacities of more than 200 million doses annually. But beyond these essential factors are also considerations for local manufacturing from the outset of the vaccine’s introduction in Africa. WHO and Gavi falling in line Even though the WHO prequalification certification has not yet approved the R21 vaccine, the WHO has expressed its support for the vaccine, acknowledging on its website that a second malaria vaccine may be coming forward. “The WHO prequalification process is also underway. WHO will continue the thorough and efficient review of the R21 vaccine and awaits the submission of additional analyses by the vaccine developer,” the global health body said. Dr Phionah Atuhebwe, New Vaccines Introduction Officer at WHO AFRO Regional Office, added that the WHO is already evaluating the vaccine’s safety, efficacy, quality and programmatic suitability. “Ghana and Nigeria have not jumped the gun because it is expected that, at national level within their jurisdiction, the national regulatory authorities can also review data once they have received information from different vaccine developers,” she said. Gavi’s Aurelia Nguyen Aurelia Nguyen, Chief Programme and Strategy Officer for Gavi, the Vaccine Alliance, also told Health Policy Watch that the alliance is prepared to provide funding for the R21 malaria vaccine. “It is a hugely exciting development with the approvals that we’ve seen in Ghana and Nigeria. This is all moving us forward towards having a second vaccine,” Nguyen said. She noted that the restricted supply of the RTS,S made it “really important” to have several tools, in addition to affordability. “It’s not just about the volumes, it’s also about the affordability. Serum Institute has made a very important public commitment in terms of keeping the cost of the vaccines to $3 or less. So we really look forward to them honoring that commitment because ultimately, it will mean that more people are protected,” Nguyen concluded. Image Credits: WHO/Fanjan Combrink, WHO/M. Nieuwenhof, WHO. Powerful Partnership to Address Backslide in Childhood Vaccinations – But No Extra Funds 24/04/2023 Stefan Anderson “No child should die of a vaccine-preventable disease,” said WHO Director-General Tedros Adhanom Ghebreyesus. The world’s largest global health organizations have announced a partnership to reverse the years-long backslide in global childhood vaccination rates caused by the COVID-19 pandemic. An estimated 67 million children missed at least one essential vaccination between 2019 and 2021 and 50 million of these didn’t receive any vaccines – setting back childhood vaccination rates to their lowest level since 2008. But the “Big Catch-Up”, billed as an “extended effort” to restore vaccination levels in children to at least pre-pandemic levels and shore up essential health services for immunization programmes, does not contain any new financial commitments. Participants include the World Health Organization (WHO), UNICEF, the vaccine alliance Gavi, the Bill & Melinda Gates Foundation and a number of national and global health organizations. In the past three years, the overburdening and disruption of health services by COVID-19 containment efforts eroded over a decade of gains in routine childhood immunization levels. The vaccination schedules of millions of children around the world were knocked-off course, exposing them to life-threatening viruses that can be prevented by existing vaccines. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters the “Big Catch-Up” partnership does not involve any new financial commitments to bolster global childhood vaccination efforts. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters on Monday that preliminary estimates indicate that the backslide in childhood vaccinations has led to “at least” a five percent increase in mortality among children. “Every one of these lives that are lost is on top of the mortality that already exists because of the imperfection of the coverage and immunization programmes,” O’Brien said. “There will continue to be these children who are at risk going forward unless they are caught up.” Over 100 countries recorded declines in childhood vaccination rates during the pandemic, but three-quarters of the 25 million children who missed vaccinations in 2021 live in just 20 low- and middle-income countries. These will be a “particular focus” for the global coalition. “Millions of children and adolescents, particularly in lower-income countries, have missed out on life-saving vaccinations, while outbreaks of these deadly [preventable] diseases have risen,” said WHO director-general Tedros Adhanom Ghebreyesus. “Catching up is a top priority. No child should die of a vaccine-preventable disease.” Inequality is still behind vaccine access When UNICEF first began tracking childhood vaccination rates in 1980, just one in 10 children in the world’s poorest countries would “ever see a trained health worker or be immunized” before their first birthday. By the start of the next decade, seven in 10 children around the world were protected by vaccines – rising steadily to a height of 86% in 2019. Despite decades of progress, the story of children not receiving essential childhood vaccines remains one of inequality and poverty. One in five children in the world’s poorest households today are ‘zero-dose’, meaning they have never received a vaccine of any kind, according to UNICEF’s 2023 State of the World’s Children report released last week. In West and Central Africa, that number rises to nearly one in two, compared to one in 20 in the wealthiest countries. “Routine vaccines are typically a child’s first entry into their health system and so children who miss out on their early vaccines are at added risk of being cut out of healthcare in the long run,” UNICEF executive director Catherine Russel said. “The longer we wait to reach and vaccinate these children, the more vulnerable they become and the greater the risk of more deadly disease outbreaks.” Asked about the role of vaccine scepticism in dropping child vaccination rates, O’Brien stressed that while the global proliferation of misinformation around vaccines is “deeply concerning” – UNICEF found vaccine confidence dropped in 52 out of 55 countries – it remains a minor factor compared to income. “The main reason that kids are unvaccinated is not anti-vax [beliefs],” O’Brien said. “The main reason why children are unvaccinated has to do with access to services, quality of services, and the full availability of programmes.” Big ambitions, no extra funding No new funding to support the goal of returning childhood vaccination rates to pre-pandemic levels is included as part of the “Big Catch-Up”. “We’ve done an assessment of the resources that are out there, and we do feel that the resources are there,” O’Brien. “There are substantial resources already in-country and still available to countries through many different mechanisms.” Meanwhile, Medecins sans Frontieres (MSF) highlighted that children in conflict zones were particularly affected. “Despite the progress made in expanding global vaccination coverage, nearly 11 million of the un- and under-vaccinated infants live in fragile or humanitarian settings, including countries affected by conflict, and remain the most vulnerable to disease outbreaks,” said Dr Sharmila Shetty, Vaccines Medical Advisor for MSF’s Access Campaign. Africa’s burden According to estimates by WHO and UNICEF, the number of zero-dose and under-immunized African children rose by 16% between 2019 and 2021 to a cumulative total of about 33 million, nearly half the global figure. At a WHO AFRO press briefing last Thursday, Gavi, The Vaccine Alliance, revealed it is working in Sierra Leone and Ghana to ensure that the millions of children and adolescent girls who missed out on vaccines during the pandemic are protected. “We’re very, very happy to be marking in a few days, the 2023 edition of the Africa Vaccination Week, and it’s a really good opportunity for us to take stock and to remind ourselves of what we have achieved but also what we are dealing with in terms of recovering from a pretty unprecedented emergency during the pandemic,” said Aurelia Nguyen, Gavi’s Chief Programme and Strategy Officer. Nguyen said that Gavi is working closely with its partners to support countries in making up lost ground and building stronger, more resilient systems. The efforts will focus on on hard-to-reach communities and implementing national programmes that are able to reach children and communities more effectively. Gavi is also focusing on the human papillomavirus (HPV) vaccine program, which was one of the hardest hit during the pandemic. With cervical cancer being the most common cause of cancer death in nearly half of sub-Saharan African countries, Nguyen noted that the HPV vaccine can prevent up to 90% of cervical cancer cases. So far, Gavi said it has supported 20 African countries to produce the HPV vaccine and received $600 million in extra investment last year to revitalize the program and strengthen health systems. “As we think about many, many challenges ahead, we also are considering the opportunities and we have a young and growing population, and so it’s really our responsibility and opportunity to make sure that we don’t leave any child behind with immunization,” said Nguyen. Additional reporting by Paul Adepoju. Image Credits: WHO / Billy Miaron. 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. 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European Commission Finally Releases Pharma Law Reforms, Proposing Cuts to Market Exclusivity for New Drugs 26/04/2023 Kerry Cullinan EU Health Commissioner Stella Kyriakides Long-anticipated European Commission proposals to reform the European Union’s pharmaceutical legislation – the biggest shake-up in 20 years – were finally made public on Wednesday. The reforms are aimed particularly at addressing access and price disparities between European states, ensuring that all EU citizens have access to the same products at the same price, EU Health Commissioner Stella Kyriakides told a media briefing. “We are putting forward proposals to ensure that medicines reach patients everywhere in Europe, in a timely and equitable fashion,” said Kyriakides. Aside from high prices and medicine shortages, the Commission is particularly concerned about “unmet medical needs, rare diseases and antimicrobial resistance (AMR)”. The proposals have six policy objectives, namely to: create a single market for medicines, thus ensuring that all patients across the EU have “timely and equitable access to safe, effective, and affordable medicines”; offer “an attractive and innovation-friendly framework” for research, development, and production of medicines in Europe; speed up procedures significantly, particularly by reducing authorisation times for medicines to 180 days, so they reach patients faster; enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU; address antimicrobial resistance (AMR) and pharmaceuticals in the environment through a One Health approach; Make medicines more environmentally sustainable. We want medicine to be more accessible, available, and affordable. Our #EUPharmaStrategy legislative reform proposes a single market of medicines that: 🔸 is patient-centric🔹 fosters innovation🔸 fights antimicrobial resistance🔹 is environmentally friendly ↓#HealthUnion — European Commission (@EU_Commission) April 26, 2023 One of its proposals involves cutting drug market exclusivity for new medicines from 10 to eight years, after which the market will be opened to generics. However, drug companies that launch new medicines in all 27 EU member states within two years of development will still be able to get the extra two years’ exclusivity. In addition, manufacturers producing treatments for “unmet medical needs” will get an extra six months of protection. As an incentive to manufacturers to develop new antibiotics, the EC proposes “transferable exclusivity vouchers (TEVs)” for drug companies that give a year of protection to any of the company’s medicines. The proposals also envisage the EU being able to set up manufacturing of vaccines and drugs using compulsory licenses during public health emergencies. Positive precedent, says MSF Dimitri Eynikel, EU Policy Advisor for Médecins Sans Frontières (MSF) Access Campaign, said that “with some tweaks”, the reforms “could set a positive precedent towards enshrining access to medicines provisions in law”. “We applaud the proposal’s bid for greater transparency: obliging companies to open their books on all direct public funding received for the research and development of medicines is a critical step to ensure that medicines are priced appropriately and affordably for the people who need them,” said Eynikel. “In addition, plans for granting more effective compulsory licenses by suspending data and market exclusivity would be historic, and should encourage other countries and regions to adopt similar measures to secure the availability of affordable medicines.” But MSF is against the introduction of vouchers to encourage the development of new antimicrobials, warning that this could “prolong pharmaceutical monopolies, undermine generic competition and severely slow down people’s access to new and affordable medicines”. Pharma unhappy However, the reaction from pharmaceutical companies has been less positive. The European Federation of Pharmaceutical Industries and Associations (EFPIA) says that the proposals will “undermine research and development in Europe while failing to address access to medicines for patients.” EFPIA Director General Nathalie Moll laid the blame for slow access to medicines at the door of different systems in EU member states: “Fixing the tenfold variation in access to new medicines across the EU, requires all partners to urgently get round the table and address the real issues rather than unworkable EU-level legislation that is destined to fail.” “Although the revised legislation was meant to improve Europe’s competitiveness, the ‘net’ impact of policies set out across these proposals, in their current form, puts European competitiveness at risk,’ said EFPIA president Hubertus von Baumbach. Meanwhile, GSK Chief Executive Emma Walmsley told Reuters that weakening market exclusivity protections “could discourage companies from researching and launching treatments in Europe”. Process The European Parliament still has to pass the proposals, which means that there are still a number of opportunities for the proposals to be tweaked or changed. However, MSF’s Eynikel appealed to EU member states and the European Parliament not to water down the provisions on transparency and compulsory licenses. World Needs Ambitious Pandemic Accord – ‘Failing is Not an Option’ says German MP 26/04/2023 Alex Winston German MP Andrew Ullmann Many challenges remain in negotiating an international pandemic treaty, experts tell a committee of the German Parliament. As COVID-19 cases decline, multilateral polarization and a weary public leaves countries at risk should another global pandemic strike, German MP Andrew Ullmann stated on Monday at the German Parliament (Bundestag). The Bundestag’s Global Health Subcommittee held a technical briefing on the international pandemic accord currently being negotiated by World Health Organization (WHO) member states to ensure better global pandemic prevention, preparedness and response. “It is imperative to complete reforms to address the gaps in international health crises management,” Ullmann said. “We need to strive for an ambitious pandemic agreement. But, of course, this is easier said than done since interests between countries show a strong divide.” The pandemic accord aims to address areas currently not covered by the International Health Regulations (IHR) – the gobal laws to prevent the international spread of disease – and improve the international community’s ability to prevent and respond to pandemics in a just and effective manner. “There were huge gaps in the COVID-19 response, and there are three key objectives. First, one must be better prepared – from the community to the country, to the regional to the global level. Two, to have a better chance at preventing future pandemics, and three, to have a better and more coordinated response, and that is the aim,” Steven Solomon, WHO’s Principal Legal Officer, told the hearing. Steven Solomon, WHO Principal Legal Officer According to the process agreed in December 2021 by governments at a special session of the World Health Assembly, the WHO’s highest decision-making body, an intergovernmental negotiating body (INB) will aim to produce a final draft of the pandemic accord for consideration by the 77th World Health Assembly in 2024. Dr Clare Wenham, Associate Professor of Global Health Policy at the London School of Economics, told the hearing that the International Health Regulations were binding on member states but required maintaining a balance between “protecting against the international spread of disease and doing so in ways which are commensurate with the risk to international travel and trade, but it’s not a panacea.” Dr Clare Wenham Pointing out several other challenges surrounding the agreement and implementation of an international treaty, Wenham noted that “there have been challenges within the IHR around data sharing and whether there is free flowing and timely information being shared between countries and WHO.” China, in particular, has come under heavy scrutiny and criticism for its perceived refusal to share information or data on COVID-19. WHO is a member-state agency but has no physical compliance mechanism to enforce its member states to implement regulations other than, as Wenham pointed out, “name and shame mechanisms.” “There are challenges with financing and cooperation issues, so governments of higher income countries are supposed to support and assist and collaborate with low-income countries to be able to improve their capacities to respond to a pandemic,” Wenham said. “Also, other governance issues have come up during the pandemic of COVID, such as a lack of consideration of secondary impacts or pandemic policy.” Secondary impacts include such things as the effect of lockdowns on people’s physical and mental health and the financial implications that saw businesses affected worldwide. Zero draft The ‘zero draft’ of the accord, released in 2023, states that “all lives have equal value, and that therefore equity should be a principle, an indicator and an outcome of pandemic prevention, preparedness and response” stressed Dr Viviana Munoz Tellez of the South Centre, an intergovernmental organization based in Geneva that helps developing countries promote their common interests in the international arena. Munoz Tellez noted the deep inequalities between member states, also exacerbated by profit-driven medical and pharmaceutical services – which the poor can often not afford. Parts of the draft treaty text are already facing strong private sector opposition for clauses that some see as impinging too much on market forces, or threatening patent protections on drugs and treatment. For instance, one of the clauses of the ‘zero-draft’ of the treaty proposes that 20% of pandemic-related products, such as vaccines or equipment, should be allocated to WHO or other global health partners, which will then ensure equal distribution among member states. “It is a global problem that we have – a number of countries that are not able to meet even basic capacities for pandemic prevention, and that response to the COVID pandemic, we saw, was highly inequitable,” Munoz Tellez told the subcommittee’s hearing. “In that sense, there has been this drive to say that part of the response for future pandemics is to have equity at the center. “Private sector had the upper hand as we’ve generally seen overall in the R&D system right now. So we think this is also a very important opportunity for the pandemic treaty to improve the global system from research and development that responds better to public health needs, not just profit incentives.” Despite the many challenges remaining, Ullmann is hopeful that all parties will be willing to compromise and “contribute to a just and efficacious global health policy.” “Failing cannot be an option as the next pandemic can be just around the corner, and no single government or institution can address this threat by itself,” the German lawmaker added in an email to Health Policy Watch, just after the briefing ended. “For sure, it is imperative to break the cycle of panic and neglect once and for all.” Global Action Against Uganda’s Anti-Homosexuality Bill Amid Surge of Violent Attacks 25/04/2023 Kerry Cullinan Protestors in Washington DC. Protestors gathered outside Ugandan embassies worldwide on Tuesday for a global day of action against that country’s Anti-Homosexuality Bill, which criminalises all LGBTQ people and proposes a series of punishments ranging from fines to the death penalty. Violence against people suspected of being LGBTQ has already surged in the past month since Uganda’s Parliament passed the Bill with almost unanimous support. However, Ugandan President Yoweri Museveni declined last week to sign the Bill into law, sending it back to parliament last week with the instruction that it be “reinforced and strengthened”. While Museveni also congratulated MPs for rejecting “the pressure from imperialists”, he has been under intense pressure from the United Nations, US and European Union members not to sign the Bill. In addition, Uganda’s Deputy Attorney General has written to the Speaker highlighting why the Bill is unconstitutional, particularly focusing on the death penalty clauses. SOUND ON 🔊: President @KagutaMuseveni speaks about the Anti-Homosexuality Bill. pic.twitter.com/aXvU0YCplN — State House Uganda (@StateHouseUg) April 24, 2023 Since the Bill was passed a month ago, hate crimes and violence against LGBTQ people have risen sharply, according to the Human Rights and Awareness and Promotion Forum (HRAPF), a legal aid organisation. HIV services have also been affected, with some LGBTQ patients being afraid to attend clinics for fear of being arrested, according to The Lancet. In the past month, HRAPF has handled 59 cases involving LGBTQ or suspected LGBTQ persons. Forty of these cases “involved violence and violations targeting the victims purely on the basis of their presumed sexuality, and affected a total of 85 persons”. There is an exponential increase in cases of violence and violations against LGBTI persons fueled by the politicisation around the Anti Homosexuality Bill 2023 Read HRAPF’s report here>>> https://t.co/2Gre5T01Uh pic.twitter.com/lWSIQxNkcZ — HRAPF (@hrapf_uganda) April 24, 2023 “In one of these cases, a group of six people were arrested and charged with having carnal knowledge against the order of nature because the area local chairperson saw a video from a gay porn site in which one of the actors looked like one of the victims,” according to HRAPF, which itself faces fines simply for assisting LGBTQ clients. “In the most recent case, an athlete who was suspected to be a transgender woman was arrested by a mob, forcefully undressed and then forced to march through the streets naked while the crowd heckled her, threw objects at her, took her photos/ videos and even fondled her.” Meanwhile, a report released on Monday points out that Western governments and aid agencies – including the UK, Dutch, Norwegian and US governments – have donated $40 million to Ugandan anti-LGBTQ religious groups such as the Inter-Religious Council of Uganda since 2014. While the report acknowledges that there is no evidence “that any of this money specifically paid for anti-LGBTQI activities”, it adds that the aid and partnerships “can boost groups’ credibility, their reputations, and their access to power and other finance”. Kenya follows Uganda A Kenyan Member of Parliament, Peter Kaluma, has tabled an almost identical Bill to his parliament shortly after returning from a meeting in Uganda where leaders of a US anti-LGBTQ group, Family Watch International (FWI), delivered keynote addresses. FWI has a long history of involvement in anti-LGBTQ activities in Africa and was involved in promoting the forerunner of the current Uganda Bill, the so-called “kill the gays” Bill passed in 2014 but stopped by the courts on a technicality. FWI founder and leader Sharon Slater has doggedly pursued an anti-LGBT agenda for years, making a wide variety of claims including that LGBT people are more likely to be paedophiles. Slater, has also played a hand in the extreme anti-LGBTQ Bill before Ghana’s parliament. I recently had the honor of meeting with Ms. Sharon Slater, President of Family Watch International, & her team. They attended the first African Regional Inter-Parliamentary Conference in Uganda, focusing on global challenges that threaten African families & values. pic.twitter.com/8RP8ba4sLJ — Janet K Museveni (@JanetMuseveni) April 4, 2023 Slater, a Mormon from Arizona, has also been campaigning for years for African governments to ban comprehensive sexuality education in schools. A proponent of “conversion therapy”, a discredited approach that aims to change a person’s sexuality, Slater has apparently convinced Museveni that such ‘therapy’ should be promoted in the Bill to encourage people to renounce their homosexuality. Family Watch International’s Sharon Slater addresing Ugandan politicians Geopolitical complications While the Anti-Homosexuality Bill has drawn condemnation from European governments and the US, this has been muted as Western governments are in a race to woo African governments away from Russia and China. Russia also persecutes LGBTQ people and has a similar anti-rights agenda as Uganda. Meanwhile, South Africa, which outlaws discrimination against citizens on the basis of sexual orientation, is the only African country to mount protests against the Bill. The opposition Economic Freedom Fighters, which has significant youth support, has marched to the Ugandan Embassy in Pretoria. Meanwhile, on Tuesday the Secretary General of the ruling African National Congress said that discrimination and persecution were against the African Charter, and called on all states to “ensure that their citizens enjoy their full human rights”. Trump Politicisation of COVID Was a ‘Comorbidity’ in Disappointing US Pandemic Response 25/04/2023 Megha Kaveri President Donald Trump listens as Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, speaks to the press in 2020. An expert investigation into the US response to the COVID-19 pandemic has concluded that the country’s performance was the most disappointing in the world. The investigation’s report was launched on Tuesday as a book, Lessons from the COVID War, providing an in-depth analysis of America’s response to the pandemic and the aftermath by the COVID Crisis Group, an independent group of experts. No country’s performance in dealing with the pandemic was more disappointing than that of the US, according to the group. They came to this conclusion as the US excess deaths during the pandemic were around 40% higher than that of Europe, despite the US possessing deeper scientific knowledge about the virus and spending trillions of dollars to address it. Donald Trump’s politicking during the start of the pandemic when he was president is heavily criticised, with the authors concluding that his politicisation of the pandemic was a “comorbidity”. The book also examines the race to develop an effective vaccine against COVID-19 (Operation Warp Speed), COVID origins and the policies adopted by the federal and state governments. The COVID Crisis Group was born in 2021 out of a need to analyse the country’s COVID-19 response given that the pandemic killed more Americans than all US wars combined since the US War of Independence. The group consisted of 34 members – physicians, public health and policy experts led by Philp Zelikow, who led the official commission that looked into the 9/11 attacks. Lab-leak theory The report examines both the lab leak theory and the animal-human transmission theory of COVID-19, but doesn’t support either of these due to lack of sufficient evidence in both cases. The origins of COVID-19 has been a controversial topic as some believe that the virus might have broken out into the general population from the high-security laboratory that conducts research on coronaviruses at the Wuhan Institute of Virology in China. However, this theory has been disputed by many other eminent scientists and the World Health Organization (WHO), who believe that COVID-19 might have originated from a spillover event at a wet market in Wuhan province. The book comes down heavily on the US Centers for Disease Prevention and Control (CDC) and says that the agency took on a reactive role in a pandemic instead of proactively leading the way. Elaborating on the activities that went behind the development of successful mRNA vaccines against COVID, the book says that both Pfizer and Moderna enjoyed tremendous support from the federal government, either through upfront investment into development or as advance purchase guarantees that ran to billions of US dollars. It also emphasises how “Operation Warp Speed”, as it was known then, was a success only because of a perfect alignment of many other factors around it. Image Credits: flickr/The White House. Official White House Photo by Andrea Hanks. Africa to Manufacture New Malaria Vaccine? 24/04/2023 Paul Adepoju A healthcare worker gives a child a dose of the world’s first malaria vaccine, RTS,S. A second malaria vaccine has now been approved. IBADAN, Nigeria – There are high hopes that the R21/Matrix-M malaria vaccine recently approved by Ghana and Nigeria will be manufactured in Africa in the not-to-distant future – a brighter-than-usual prospect for this World Malaria Day (25 April). Earlier this month, Ghana’s Food and Drugs Authority (FDA) approved the R21/Matrix-M malaria vaccine manufactured by the Serum Institute of India (SII) for use in children aged from five months to three years, the age group at the highest risk of death from malaria. This was despite the vaccine not yet being given World Health Organization (WHO) prequalification approval. SII, the manufacturing and commercialisation license holder for the vaccine, described Ghana’s approval as the “first crucial step [that] will enable the vaccine to help Ghanaian and African children to effectively combat malaria”. “The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives,” said Adar Poonawalla, SII CEO. Shortly afterwards, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) also granted a “registration approval” for the vaccine to SII. The agency said it had received the dossier of the vaccine and it had been subjected to independent review at two levels. The agency added that the vaccine’s dossier substantially complied with best international standards, and that its Joint Review Committee had concluded the vaccine data was robust and met the criteria for efficacy, safety, and quality. Local production? Ghana’s regulator announced that the application for regulatory approval had been submitted by SII’s ‘local agent’, DEK, which expects to eventually manufacture the vaccine locally. “The status of the [Ghana] FDA Lab creates a great advantage for the local agent who hopefully will be manufacturing the malaria vaccine in Ghana in the near future,” the agency stated. A few days after the regulatory approval, a ground-breaking ceremony of the DEK Vaccines Limited’s vaccine fill-and-finish plant was held. The company is a private sector-led consortium of Ghanaian pharmaceutical companies. At the ceremony, Ghanaian President Nana Addo Dankwa Akufo-Addo, said it “will help our nation realise the dream of becoming self-sufficient in the manufacture of vaccines”. Meanwhile, Nigeria’s regulator announced Fidson Healthcare Ltd, a major local bourse-listed player in the country’s pharmaceutical industry, as the vaccine’s Marketing Authorization Holder (MAH). This authorizes the Nigerian firm licensed to distribute, sell and commercialize the vaccine in Nigeria. The Nigerian government also revealed in September 2022 that it had signed a local vaccine manufacturing agreement involving Biovaccines Nigeria Limited (a joint venture between the Federal Government of Nigeria and May & Baker Nigeria Plc), and SII. “The government has approved 15% of the vaccines that UNICEF normally supplies to Biovaccines to supply through contract manufacturing with the Serum Institute of India. With that, the institute will now be comfortable enough to come and join Biovaccines Nigeria in building its manufacturing plant here in Nigeria in Ota,” Nigerian health minister, Osagie Ehanire said. From Oxford to West Africa via India An infant receiving the RTS,S malaria vaccine in Ghana in 2019. Designed and developed at the University of Oxford, the vaccine has been tested in the United Kingdom, Thailand, and several African countries. A Phase Three trial that is underway in Burkina Faso, Kenya, Mali and Tanzania has enrolled 4,800 children and the results are expected later this year. While the regulator in Nigeria has also recommended an in-country Phase Four clinical trial or pharmacovigilance study in the implementation, given the peculiarity and heterogeneous nature of malaria in Nigeria, it noted that the efficacy results from the vaccine’s clinical trials contributed to its decision to approve it. Last year, the Oxford researchers and their partners reported from a Phase 2B trial that a booster dose of R21/Matrix-M at one year, following a primary three-dose regime, maintained high efficacy against malaria, and continued to meet the WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. This followed 2021 results from the Phase 2B trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77%. Recent data from the large phase III trial also show high levels of efficacy and a reassuring safety profile. Prof Adrian Hill, chief investigator for R21/Matrix-M programme, and Director of the Jenner Institute at the University of Oxford, described the regulatory approval of the vaccine as the culmination of 30 years of malaria vaccine research at Oxford. “I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children,” Hill said. The vaccine contains Novavax’s Matrix-M which is a saponin-based adjuvant that enhances the immune system response, making it more potent and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This technology has also been used successfully in Novavax’s COVID-19 vaccine and is a key component of other development-stage vaccines. An approval without a WHO prequalification Unlike the developments surrounding the approval of the COVID-19 vaccines in the African countries that largely followed a prequalification approval by the WHO, both Ghana and Nigerian regulators went ahead to approve the vaccine without any WHO approval. In addition to affirming their regulators’ competence and authorization to undertake such approvals, Dr Franklin Asiedu–Bekoe, Director of Public Health in Ghana, told Health Policy Watch that the vaccine – the second malaria vaccine that the country is rolling out – will be closely reviewed by the country’s team of scientists. “In Ghana, we have 93 districts that are now using the TRS,S. There are a number of districts that are yet to be using it. So if we have a vaccine, which is good, I think nothing stops us from using it,” he argued. Moreover, Prof William K. Ampofo, Secretary of the Presidential Committee on Vaccine Manufacturing and Development, Ghana, added that the approval was in response to the manufacturer’s application. “The vaccine was approved based on the application by the manufacturer Serum Institute. It was not an independent decision by the Ghana FDA. It was in response to the application by the Serum Institute for the R21 vaccine based on the data that had been accumulated,” Ampofo told Health Policy Watch. Local manufacturing elements of both approvals In the weeks before regulatory approval for the R21 vaccine, Ghana officially expanded access to the WHO-approved RTS,S malaria vaccine. Four years on, more than 4.5 million doses of the vaccine have been administered through the countries’ routine immunization programmes. “Community demand for the vaccine is high and the vaccine is well accepted in African communities, even when additional visits to vaccination clinics are required to receive the four-dose schedule,” WHO revealed. But RTS,S rollout has been plagued with concerns regarding its comparatively minimal efficacy, high cost and limited supply. In sharp contrast, R21’s demonstrably higher efficacy (more than 75% over 12 months) and comparatively lower cost ($3 compared with RTS,S’ $5 per dose) made it even more attractive to African countries – along with the manufacturer’s announcement of potential manufacturing capacities of more than 200 million doses annually. But beyond these essential factors are also considerations for local manufacturing from the outset of the vaccine’s introduction in Africa. WHO and Gavi falling in line Even though the WHO prequalification certification has not yet approved the R21 vaccine, the WHO has expressed its support for the vaccine, acknowledging on its website that a second malaria vaccine may be coming forward. “The WHO prequalification process is also underway. WHO will continue the thorough and efficient review of the R21 vaccine and awaits the submission of additional analyses by the vaccine developer,” the global health body said. Dr Phionah Atuhebwe, New Vaccines Introduction Officer at WHO AFRO Regional Office, added that the WHO is already evaluating the vaccine’s safety, efficacy, quality and programmatic suitability. “Ghana and Nigeria have not jumped the gun because it is expected that, at national level within their jurisdiction, the national regulatory authorities can also review data once they have received information from different vaccine developers,” she said. Gavi’s Aurelia Nguyen Aurelia Nguyen, Chief Programme and Strategy Officer for Gavi, the Vaccine Alliance, also told Health Policy Watch that the alliance is prepared to provide funding for the R21 malaria vaccine. “It is a hugely exciting development with the approvals that we’ve seen in Ghana and Nigeria. This is all moving us forward towards having a second vaccine,” Nguyen said. She noted that the restricted supply of the RTS,S made it “really important” to have several tools, in addition to affordability. “It’s not just about the volumes, it’s also about the affordability. Serum Institute has made a very important public commitment in terms of keeping the cost of the vaccines to $3 or less. So we really look forward to them honoring that commitment because ultimately, it will mean that more people are protected,” Nguyen concluded. Image Credits: WHO/Fanjan Combrink, WHO/M. Nieuwenhof, WHO. Powerful Partnership to Address Backslide in Childhood Vaccinations – But No Extra Funds 24/04/2023 Stefan Anderson “No child should die of a vaccine-preventable disease,” said WHO Director-General Tedros Adhanom Ghebreyesus. The world’s largest global health organizations have announced a partnership to reverse the years-long backslide in global childhood vaccination rates caused by the COVID-19 pandemic. An estimated 67 million children missed at least one essential vaccination between 2019 and 2021 and 50 million of these didn’t receive any vaccines – setting back childhood vaccination rates to their lowest level since 2008. But the “Big Catch-Up”, billed as an “extended effort” to restore vaccination levels in children to at least pre-pandemic levels and shore up essential health services for immunization programmes, does not contain any new financial commitments. Participants include the World Health Organization (WHO), UNICEF, the vaccine alliance Gavi, the Bill & Melinda Gates Foundation and a number of national and global health organizations. In the past three years, the overburdening and disruption of health services by COVID-19 containment efforts eroded over a decade of gains in routine childhood immunization levels. The vaccination schedules of millions of children around the world were knocked-off course, exposing them to life-threatening viruses that can be prevented by existing vaccines. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters the “Big Catch-Up” partnership does not involve any new financial commitments to bolster global childhood vaccination efforts. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters on Monday that preliminary estimates indicate that the backslide in childhood vaccinations has led to “at least” a five percent increase in mortality among children. “Every one of these lives that are lost is on top of the mortality that already exists because of the imperfection of the coverage and immunization programmes,” O’Brien said. “There will continue to be these children who are at risk going forward unless they are caught up.” Over 100 countries recorded declines in childhood vaccination rates during the pandemic, but three-quarters of the 25 million children who missed vaccinations in 2021 live in just 20 low- and middle-income countries. These will be a “particular focus” for the global coalition. “Millions of children and adolescents, particularly in lower-income countries, have missed out on life-saving vaccinations, while outbreaks of these deadly [preventable] diseases have risen,” said WHO director-general Tedros Adhanom Ghebreyesus. “Catching up is a top priority. No child should die of a vaccine-preventable disease.” Inequality is still behind vaccine access When UNICEF first began tracking childhood vaccination rates in 1980, just one in 10 children in the world’s poorest countries would “ever see a trained health worker or be immunized” before their first birthday. By the start of the next decade, seven in 10 children around the world were protected by vaccines – rising steadily to a height of 86% in 2019. Despite decades of progress, the story of children not receiving essential childhood vaccines remains one of inequality and poverty. One in five children in the world’s poorest households today are ‘zero-dose’, meaning they have never received a vaccine of any kind, according to UNICEF’s 2023 State of the World’s Children report released last week. In West and Central Africa, that number rises to nearly one in two, compared to one in 20 in the wealthiest countries. “Routine vaccines are typically a child’s first entry into their health system and so children who miss out on their early vaccines are at added risk of being cut out of healthcare in the long run,” UNICEF executive director Catherine Russel said. “The longer we wait to reach and vaccinate these children, the more vulnerable they become and the greater the risk of more deadly disease outbreaks.” Asked about the role of vaccine scepticism in dropping child vaccination rates, O’Brien stressed that while the global proliferation of misinformation around vaccines is “deeply concerning” – UNICEF found vaccine confidence dropped in 52 out of 55 countries – it remains a minor factor compared to income. “The main reason that kids are unvaccinated is not anti-vax [beliefs],” O’Brien said. “The main reason why children are unvaccinated has to do with access to services, quality of services, and the full availability of programmes.” Big ambitions, no extra funding No new funding to support the goal of returning childhood vaccination rates to pre-pandemic levels is included as part of the “Big Catch-Up”. “We’ve done an assessment of the resources that are out there, and we do feel that the resources are there,” O’Brien. “There are substantial resources already in-country and still available to countries through many different mechanisms.” Meanwhile, Medecins sans Frontieres (MSF) highlighted that children in conflict zones were particularly affected. “Despite the progress made in expanding global vaccination coverage, nearly 11 million of the un- and under-vaccinated infants live in fragile or humanitarian settings, including countries affected by conflict, and remain the most vulnerable to disease outbreaks,” said Dr Sharmila Shetty, Vaccines Medical Advisor for MSF’s Access Campaign. Africa’s burden According to estimates by WHO and UNICEF, the number of zero-dose and under-immunized African children rose by 16% between 2019 and 2021 to a cumulative total of about 33 million, nearly half the global figure. At a WHO AFRO press briefing last Thursday, Gavi, The Vaccine Alliance, revealed it is working in Sierra Leone and Ghana to ensure that the millions of children and adolescent girls who missed out on vaccines during the pandemic are protected. “We’re very, very happy to be marking in a few days, the 2023 edition of the Africa Vaccination Week, and it’s a really good opportunity for us to take stock and to remind ourselves of what we have achieved but also what we are dealing with in terms of recovering from a pretty unprecedented emergency during the pandemic,” said Aurelia Nguyen, Gavi’s Chief Programme and Strategy Officer. Nguyen said that Gavi is working closely with its partners to support countries in making up lost ground and building stronger, more resilient systems. The efforts will focus on on hard-to-reach communities and implementing national programmes that are able to reach children and communities more effectively. Gavi is also focusing on the human papillomavirus (HPV) vaccine program, which was one of the hardest hit during the pandemic. With cervical cancer being the most common cause of cancer death in nearly half of sub-Saharan African countries, Nguyen noted that the HPV vaccine can prevent up to 90% of cervical cancer cases. So far, Gavi said it has supported 20 African countries to produce the HPV vaccine and received $600 million in extra investment last year to revitalize the program and strengthen health systems. “As we think about many, many challenges ahead, we also are considering the opportunities and we have a young and growing population, and so it’s really our responsibility and opportunity to make sure that we don’t leave any child behind with immunization,” said Nguyen. Additional reporting by Paul Adepoju. Image Credits: WHO / Billy Miaron. 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. 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World Needs Ambitious Pandemic Accord – ‘Failing is Not an Option’ says German MP 26/04/2023 Alex Winston German MP Andrew Ullmann Many challenges remain in negotiating an international pandemic treaty, experts tell a committee of the German Parliament. As COVID-19 cases decline, multilateral polarization and a weary public leaves countries at risk should another global pandemic strike, German MP Andrew Ullmann stated on Monday at the German Parliament (Bundestag). The Bundestag’s Global Health Subcommittee held a technical briefing on the international pandemic accord currently being negotiated by World Health Organization (WHO) member states to ensure better global pandemic prevention, preparedness and response. “It is imperative to complete reforms to address the gaps in international health crises management,” Ullmann said. “We need to strive for an ambitious pandemic agreement. But, of course, this is easier said than done since interests between countries show a strong divide.” The pandemic accord aims to address areas currently not covered by the International Health Regulations (IHR) – the gobal laws to prevent the international spread of disease – and improve the international community’s ability to prevent and respond to pandemics in a just and effective manner. “There were huge gaps in the COVID-19 response, and there are three key objectives. First, one must be better prepared – from the community to the country, to the regional to the global level. Two, to have a better chance at preventing future pandemics, and three, to have a better and more coordinated response, and that is the aim,” Steven Solomon, WHO’s Principal Legal Officer, told the hearing. Steven Solomon, WHO Principal Legal Officer According to the process agreed in December 2021 by governments at a special session of the World Health Assembly, the WHO’s highest decision-making body, an intergovernmental negotiating body (INB) will aim to produce a final draft of the pandemic accord for consideration by the 77th World Health Assembly in 2024. Dr Clare Wenham, Associate Professor of Global Health Policy at the London School of Economics, told the hearing that the International Health Regulations were binding on member states but required maintaining a balance between “protecting against the international spread of disease and doing so in ways which are commensurate with the risk to international travel and trade, but it’s not a panacea.” Dr Clare Wenham Pointing out several other challenges surrounding the agreement and implementation of an international treaty, Wenham noted that “there have been challenges within the IHR around data sharing and whether there is free flowing and timely information being shared between countries and WHO.” China, in particular, has come under heavy scrutiny and criticism for its perceived refusal to share information or data on COVID-19. WHO is a member-state agency but has no physical compliance mechanism to enforce its member states to implement regulations other than, as Wenham pointed out, “name and shame mechanisms.” “There are challenges with financing and cooperation issues, so governments of higher income countries are supposed to support and assist and collaborate with low-income countries to be able to improve their capacities to respond to a pandemic,” Wenham said. “Also, other governance issues have come up during the pandemic of COVID, such as a lack of consideration of secondary impacts or pandemic policy.” Secondary impacts include such things as the effect of lockdowns on people’s physical and mental health and the financial implications that saw businesses affected worldwide. Zero draft The ‘zero draft’ of the accord, released in 2023, states that “all lives have equal value, and that therefore equity should be a principle, an indicator and an outcome of pandemic prevention, preparedness and response” stressed Dr Viviana Munoz Tellez of the South Centre, an intergovernmental organization based in Geneva that helps developing countries promote their common interests in the international arena. Munoz Tellez noted the deep inequalities between member states, also exacerbated by profit-driven medical and pharmaceutical services – which the poor can often not afford. Parts of the draft treaty text are already facing strong private sector opposition for clauses that some see as impinging too much on market forces, or threatening patent protections on drugs and treatment. For instance, one of the clauses of the ‘zero-draft’ of the treaty proposes that 20% of pandemic-related products, such as vaccines or equipment, should be allocated to WHO or other global health partners, which will then ensure equal distribution among member states. “It is a global problem that we have – a number of countries that are not able to meet even basic capacities for pandemic prevention, and that response to the COVID pandemic, we saw, was highly inequitable,” Munoz Tellez told the subcommittee’s hearing. “In that sense, there has been this drive to say that part of the response for future pandemics is to have equity at the center. “Private sector had the upper hand as we’ve generally seen overall in the R&D system right now. So we think this is also a very important opportunity for the pandemic treaty to improve the global system from research and development that responds better to public health needs, not just profit incentives.” Despite the many challenges remaining, Ullmann is hopeful that all parties will be willing to compromise and “contribute to a just and efficacious global health policy.” “Failing cannot be an option as the next pandemic can be just around the corner, and no single government or institution can address this threat by itself,” the German lawmaker added in an email to Health Policy Watch, just after the briefing ended. “For sure, it is imperative to break the cycle of panic and neglect once and for all.” Global Action Against Uganda’s Anti-Homosexuality Bill Amid Surge of Violent Attacks 25/04/2023 Kerry Cullinan Protestors in Washington DC. Protestors gathered outside Ugandan embassies worldwide on Tuesday for a global day of action against that country’s Anti-Homosexuality Bill, which criminalises all LGBTQ people and proposes a series of punishments ranging from fines to the death penalty. Violence against people suspected of being LGBTQ has already surged in the past month since Uganda’s Parliament passed the Bill with almost unanimous support. However, Ugandan President Yoweri Museveni declined last week to sign the Bill into law, sending it back to parliament last week with the instruction that it be “reinforced and strengthened”. While Museveni also congratulated MPs for rejecting “the pressure from imperialists”, he has been under intense pressure from the United Nations, US and European Union members not to sign the Bill. In addition, Uganda’s Deputy Attorney General has written to the Speaker highlighting why the Bill is unconstitutional, particularly focusing on the death penalty clauses. SOUND ON 🔊: President @KagutaMuseveni speaks about the Anti-Homosexuality Bill. pic.twitter.com/aXvU0YCplN — State House Uganda (@StateHouseUg) April 24, 2023 Since the Bill was passed a month ago, hate crimes and violence against LGBTQ people have risen sharply, according to the Human Rights and Awareness and Promotion Forum (HRAPF), a legal aid organisation. HIV services have also been affected, with some LGBTQ patients being afraid to attend clinics for fear of being arrested, according to The Lancet. In the past month, HRAPF has handled 59 cases involving LGBTQ or suspected LGBTQ persons. Forty of these cases “involved violence and violations targeting the victims purely on the basis of their presumed sexuality, and affected a total of 85 persons”. There is an exponential increase in cases of violence and violations against LGBTI persons fueled by the politicisation around the Anti Homosexuality Bill 2023 Read HRAPF’s report here>>> https://t.co/2Gre5T01Uh pic.twitter.com/lWSIQxNkcZ — HRAPF (@hrapf_uganda) April 24, 2023 “In one of these cases, a group of six people were arrested and charged with having carnal knowledge against the order of nature because the area local chairperson saw a video from a gay porn site in which one of the actors looked like one of the victims,” according to HRAPF, which itself faces fines simply for assisting LGBTQ clients. “In the most recent case, an athlete who was suspected to be a transgender woman was arrested by a mob, forcefully undressed and then forced to march through the streets naked while the crowd heckled her, threw objects at her, took her photos/ videos and even fondled her.” Meanwhile, a report released on Monday points out that Western governments and aid agencies – including the UK, Dutch, Norwegian and US governments – have donated $40 million to Ugandan anti-LGBTQ religious groups such as the Inter-Religious Council of Uganda since 2014. While the report acknowledges that there is no evidence “that any of this money specifically paid for anti-LGBTQI activities”, it adds that the aid and partnerships “can boost groups’ credibility, their reputations, and their access to power and other finance”. Kenya follows Uganda A Kenyan Member of Parliament, Peter Kaluma, has tabled an almost identical Bill to his parliament shortly after returning from a meeting in Uganda where leaders of a US anti-LGBTQ group, Family Watch International (FWI), delivered keynote addresses. FWI has a long history of involvement in anti-LGBTQ activities in Africa and was involved in promoting the forerunner of the current Uganda Bill, the so-called “kill the gays” Bill passed in 2014 but stopped by the courts on a technicality. FWI founder and leader Sharon Slater has doggedly pursued an anti-LGBT agenda for years, making a wide variety of claims including that LGBT people are more likely to be paedophiles. Slater, has also played a hand in the extreme anti-LGBTQ Bill before Ghana’s parliament. I recently had the honor of meeting with Ms. Sharon Slater, President of Family Watch International, & her team. They attended the first African Regional Inter-Parliamentary Conference in Uganda, focusing on global challenges that threaten African families & values. pic.twitter.com/8RP8ba4sLJ — Janet K Museveni (@JanetMuseveni) April 4, 2023 Slater, a Mormon from Arizona, has also been campaigning for years for African governments to ban comprehensive sexuality education in schools. A proponent of “conversion therapy”, a discredited approach that aims to change a person’s sexuality, Slater has apparently convinced Museveni that such ‘therapy’ should be promoted in the Bill to encourage people to renounce their homosexuality. Family Watch International’s Sharon Slater addresing Ugandan politicians Geopolitical complications While the Anti-Homosexuality Bill has drawn condemnation from European governments and the US, this has been muted as Western governments are in a race to woo African governments away from Russia and China. Russia also persecutes LGBTQ people and has a similar anti-rights agenda as Uganda. Meanwhile, South Africa, which outlaws discrimination against citizens on the basis of sexual orientation, is the only African country to mount protests against the Bill. The opposition Economic Freedom Fighters, which has significant youth support, has marched to the Ugandan Embassy in Pretoria. Meanwhile, on Tuesday the Secretary General of the ruling African National Congress said that discrimination and persecution were against the African Charter, and called on all states to “ensure that their citizens enjoy their full human rights”. Trump Politicisation of COVID Was a ‘Comorbidity’ in Disappointing US Pandemic Response 25/04/2023 Megha Kaveri President Donald Trump listens as Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, speaks to the press in 2020. An expert investigation into the US response to the COVID-19 pandemic has concluded that the country’s performance was the most disappointing in the world. The investigation’s report was launched on Tuesday as a book, Lessons from the COVID War, providing an in-depth analysis of America’s response to the pandemic and the aftermath by the COVID Crisis Group, an independent group of experts. No country’s performance in dealing with the pandemic was more disappointing than that of the US, according to the group. They came to this conclusion as the US excess deaths during the pandemic were around 40% higher than that of Europe, despite the US possessing deeper scientific knowledge about the virus and spending trillions of dollars to address it. Donald Trump’s politicking during the start of the pandemic when he was president is heavily criticised, with the authors concluding that his politicisation of the pandemic was a “comorbidity”. The book also examines the race to develop an effective vaccine against COVID-19 (Operation Warp Speed), COVID origins and the policies adopted by the federal and state governments. The COVID Crisis Group was born in 2021 out of a need to analyse the country’s COVID-19 response given that the pandemic killed more Americans than all US wars combined since the US War of Independence. The group consisted of 34 members – physicians, public health and policy experts led by Philp Zelikow, who led the official commission that looked into the 9/11 attacks. Lab-leak theory The report examines both the lab leak theory and the animal-human transmission theory of COVID-19, but doesn’t support either of these due to lack of sufficient evidence in both cases. The origins of COVID-19 has been a controversial topic as some believe that the virus might have broken out into the general population from the high-security laboratory that conducts research on coronaviruses at the Wuhan Institute of Virology in China. However, this theory has been disputed by many other eminent scientists and the World Health Organization (WHO), who believe that COVID-19 might have originated from a spillover event at a wet market in Wuhan province. The book comes down heavily on the US Centers for Disease Prevention and Control (CDC) and says that the agency took on a reactive role in a pandemic instead of proactively leading the way. Elaborating on the activities that went behind the development of successful mRNA vaccines against COVID, the book says that both Pfizer and Moderna enjoyed tremendous support from the federal government, either through upfront investment into development or as advance purchase guarantees that ran to billions of US dollars. It also emphasises how “Operation Warp Speed”, as it was known then, was a success only because of a perfect alignment of many other factors around it. Image Credits: flickr/The White House. Official White House Photo by Andrea Hanks. Africa to Manufacture New Malaria Vaccine? 24/04/2023 Paul Adepoju A healthcare worker gives a child a dose of the world’s first malaria vaccine, RTS,S. A second malaria vaccine has now been approved. IBADAN, Nigeria – There are high hopes that the R21/Matrix-M malaria vaccine recently approved by Ghana and Nigeria will be manufactured in Africa in the not-to-distant future – a brighter-than-usual prospect for this World Malaria Day (25 April). Earlier this month, Ghana’s Food and Drugs Authority (FDA) approved the R21/Matrix-M malaria vaccine manufactured by the Serum Institute of India (SII) for use in children aged from five months to three years, the age group at the highest risk of death from malaria. This was despite the vaccine not yet being given World Health Organization (WHO) prequalification approval. SII, the manufacturing and commercialisation license holder for the vaccine, described Ghana’s approval as the “first crucial step [that] will enable the vaccine to help Ghanaian and African children to effectively combat malaria”. “The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives,” said Adar Poonawalla, SII CEO. Shortly afterwards, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) also granted a “registration approval” for the vaccine to SII. The agency said it had received the dossier of the vaccine and it had been subjected to independent review at two levels. The agency added that the vaccine’s dossier substantially complied with best international standards, and that its Joint Review Committee had concluded the vaccine data was robust and met the criteria for efficacy, safety, and quality. Local production? Ghana’s regulator announced that the application for regulatory approval had been submitted by SII’s ‘local agent’, DEK, which expects to eventually manufacture the vaccine locally. “The status of the [Ghana] FDA Lab creates a great advantage for the local agent who hopefully will be manufacturing the malaria vaccine in Ghana in the near future,” the agency stated. A few days after the regulatory approval, a ground-breaking ceremony of the DEK Vaccines Limited’s vaccine fill-and-finish plant was held. The company is a private sector-led consortium of Ghanaian pharmaceutical companies. At the ceremony, Ghanaian President Nana Addo Dankwa Akufo-Addo, said it “will help our nation realise the dream of becoming self-sufficient in the manufacture of vaccines”. Meanwhile, Nigeria’s regulator announced Fidson Healthcare Ltd, a major local bourse-listed player in the country’s pharmaceutical industry, as the vaccine’s Marketing Authorization Holder (MAH). This authorizes the Nigerian firm licensed to distribute, sell and commercialize the vaccine in Nigeria. The Nigerian government also revealed in September 2022 that it had signed a local vaccine manufacturing agreement involving Biovaccines Nigeria Limited (a joint venture between the Federal Government of Nigeria and May & Baker Nigeria Plc), and SII. “The government has approved 15% of the vaccines that UNICEF normally supplies to Biovaccines to supply through contract manufacturing with the Serum Institute of India. With that, the institute will now be comfortable enough to come and join Biovaccines Nigeria in building its manufacturing plant here in Nigeria in Ota,” Nigerian health minister, Osagie Ehanire said. From Oxford to West Africa via India An infant receiving the RTS,S malaria vaccine in Ghana in 2019. Designed and developed at the University of Oxford, the vaccine has been tested in the United Kingdom, Thailand, and several African countries. A Phase Three trial that is underway in Burkina Faso, Kenya, Mali and Tanzania has enrolled 4,800 children and the results are expected later this year. While the regulator in Nigeria has also recommended an in-country Phase Four clinical trial or pharmacovigilance study in the implementation, given the peculiarity and heterogeneous nature of malaria in Nigeria, it noted that the efficacy results from the vaccine’s clinical trials contributed to its decision to approve it. Last year, the Oxford researchers and their partners reported from a Phase 2B trial that a booster dose of R21/Matrix-M at one year, following a primary three-dose regime, maintained high efficacy against malaria, and continued to meet the WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. This followed 2021 results from the Phase 2B trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77%. Recent data from the large phase III trial also show high levels of efficacy and a reassuring safety profile. Prof Adrian Hill, chief investigator for R21/Matrix-M programme, and Director of the Jenner Institute at the University of Oxford, described the regulatory approval of the vaccine as the culmination of 30 years of malaria vaccine research at Oxford. “I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children,” Hill said. The vaccine contains Novavax’s Matrix-M which is a saponin-based adjuvant that enhances the immune system response, making it more potent and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This technology has also been used successfully in Novavax’s COVID-19 vaccine and is a key component of other development-stage vaccines. An approval without a WHO prequalification Unlike the developments surrounding the approval of the COVID-19 vaccines in the African countries that largely followed a prequalification approval by the WHO, both Ghana and Nigerian regulators went ahead to approve the vaccine without any WHO approval. In addition to affirming their regulators’ competence and authorization to undertake such approvals, Dr Franklin Asiedu–Bekoe, Director of Public Health in Ghana, told Health Policy Watch that the vaccine – the second malaria vaccine that the country is rolling out – will be closely reviewed by the country’s team of scientists. “In Ghana, we have 93 districts that are now using the TRS,S. There are a number of districts that are yet to be using it. So if we have a vaccine, which is good, I think nothing stops us from using it,” he argued. Moreover, Prof William K. Ampofo, Secretary of the Presidential Committee on Vaccine Manufacturing and Development, Ghana, added that the approval was in response to the manufacturer’s application. “The vaccine was approved based on the application by the manufacturer Serum Institute. It was not an independent decision by the Ghana FDA. It was in response to the application by the Serum Institute for the R21 vaccine based on the data that had been accumulated,” Ampofo told Health Policy Watch. Local manufacturing elements of both approvals In the weeks before regulatory approval for the R21 vaccine, Ghana officially expanded access to the WHO-approved RTS,S malaria vaccine. Four years on, more than 4.5 million doses of the vaccine have been administered through the countries’ routine immunization programmes. “Community demand for the vaccine is high and the vaccine is well accepted in African communities, even when additional visits to vaccination clinics are required to receive the four-dose schedule,” WHO revealed. But RTS,S rollout has been plagued with concerns regarding its comparatively minimal efficacy, high cost and limited supply. In sharp contrast, R21’s demonstrably higher efficacy (more than 75% over 12 months) and comparatively lower cost ($3 compared with RTS,S’ $5 per dose) made it even more attractive to African countries – along with the manufacturer’s announcement of potential manufacturing capacities of more than 200 million doses annually. But beyond these essential factors are also considerations for local manufacturing from the outset of the vaccine’s introduction in Africa. WHO and Gavi falling in line Even though the WHO prequalification certification has not yet approved the R21 vaccine, the WHO has expressed its support for the vaccine, acknowledging on its website that a second malaria vaccine may be coming forward. “The WHO prequalification process is also underway. WHO will continue the thorough and efficient review of the R21 vaccine and awaits the submission of additional analyses by the vaccine developer,” the global health body said. Dr Phionah Atuhebwe, New Vaccines Introduction Officer at WHO AFRO Regional Office, added that the WHO is already evaluating the vaccine’s safety, efficacy, quality and programmatic suitability. “Ghana and Nigeria have not jumped the gun because it is expected that, at national level within their jurisdiction, the national regulatory authorities can also review data once they have received information from different vaccine developers,” she said. Gavi’s Aurelia Nguyen Aurelia Nguyen, Chief Programme and Strategy Officer for Gavi, the Vaccine Alliance, also told Health Policy Watch that the alliance is prepared to provide funding for the R21 malaria vaccine. “It is a hugely exciting development with the approvals that we’ve seen in Ghana and Nigeria. This is all moving us forward towards having a second vaccine,” Nguyen said. She noted that the restricted supply of the RTS,S made it “really important” to have several tools, in addition to affordability. “It’s not just about the volumes, it’s also about the affordability. Serum Institute has made a very important public commitment in terms of keeping the cost of the vaccines to $3 or less. So we really look forward to them honoring that commitment because ultimately, it will mean that more people are protected,” Nguyen concluded. Image Credits: WHO/Fanjan Combrink, WHO/M. Nieuwenhof, WHO. Powerful Partnership to Address Backslide in Childhood Vaccinations – But No Extra Funds 24/04/2023 Stefan Anderson “No child should die of a vaccine-preventable disease,” said WHO Director-General Tedros Adhanom Ghebreyesus. The world’s largest global health organizations have announced a partnership to reverse the years-long backslide in global childhood vaccination rates caused by the COVID-19 pandemic. An estimated 67 million children missed at least one essential vaccination between 2019 and 2021 and 50 million of these didn’t receive any vaccines – setting back childhood vaccination rates to their lowest level since 2008. But the “Big Catch-Up”, billed as an “extended effort” to restore vaccination levels in children to at least pre-pandemic levels and shore up essential health services for immunization programmes, does not contain any new financial commitments. Participants include the World Health Organization (WHO), UNICEF, the vaccine alliance Gavi, the Bill & Melinda Gates Foundation and a number of national and global health organizations. In the past three years, the overburdening and disruption of health services by COVID-19 containment efforts eroded over a decade of gains in routine childhood immunization levels. The vaccination schedules of millions of children around the world were knocked-off course, exposing them to life-threatening viruses that can be prevented by existing vaccines. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters the “Big Catch-Up” partnership does not involve any new financial commitments to bolster global childhood vaccination efforts. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters on Monday that preliminary estimates indicate that the backslide in childhood vaccinations has led to “at least” a five percent increase in mortality among children. “Every one of these lives that are lost is on top of the mortality that already exists because of the imperfection of the coverage and immunization programmes,” O’Brien said. “There will continue to be these children who are at risk going forward unless they are caught up.” Over 100 countries recorded declines in childhood vaccination rates during the pandemic, but three-quarters of the 25 million children who missed vaccinations in 2021 live in just 20 low- and middle-income countries. These will be a “particular focus” for the global coalition. “Millions of children and adolescents, particularly in lower-income countries, have missed out on life-saving vaccinations, while outbreaks of these deadly [preventable] diseases have risen,” said WHO director-general Tedros Adhanom Ghebreyesus. “Catching up is a top priority. No child should die of a vaccine-preventable disease.” Inequality is still behind vaccine access When UNICEF first began tracking childhood vaccination rates in 1980, just one in 10 children in the world’s poorest countries would “ever see a trained health worker or be immunized” before their first birthday. By the start of the next decade, seven in 10 children around the world were protected by vaccines – rising steadily to a height of 86% in 2019. Despite decades of progress, the story of children not receiving essential childhood vaccines remains one of inequality and poverty. One in five children in the world’s poorest households today are ‘zero-dose’, meaning they have never received a vaccine of any kind, according to UNICEF’s 2023 State of the World’s Children report released last week. In West and Central Africa, that number rises to nearly one in two, compared to one in 20 in the wealthiest countries. “Routine vaccines are typically a child’s first entry into their health system and so children who miss out on their early vaccines are at added risk of being cut out of healthcare in the long run,” UNICEF executive director Catherine Russel said. “The longer we wait to reach and vaccinate these children, the more vulnerable they become and the greater the risk of more deadly disease outbreaks.” Asked about the role of vaccine scepticism in dropping child vaccination rates, O’Brien stressed that while the global proliferation of misinformation around vaccines is “deeply concerning” – UNICEF found vaccine confidence dropped in 52 out of 55 countries – it remains a minor factor compared to income. “The main reason that kids are unvaccinated is not anti-vax [beliefs],” O’Brien said. “The main reason why children are unvaccinated has to do with access to services, quality of services, and the full availability of programmes.” Big ambitions, no extra funding No new funding to support the goal of returning childhood vaccination rates to pre-pandemic levels is included as part of the “Big Catch-Up”. “We’ve done an assessment of the resources that are out there, and we do feel that the resources are there,” O’Brien. “There are substantial resources already in-country and still available to countries through many different mechanisms.” Meanwhile, Medecins sans Frontieres (MSF) highlighted that children in conflict zones were particularly affected. “Despite the progress made in expanding global vaccination coverage, nearly 11 million of the un- and under-vaccinated infants live in fragile or humanitarian settings, including countries affected by conflict, and remain the most vulnerable to disease outbreaks,” said Dr Sharmila Shetty, Vaccines Medical Advisor for MSF’s Access Campaign. Africa’s burden According to estimates by WHO and UNICEF, the number of zero-dose and under-immunized African children rose by 16% between 2019 and 2021 to a cumulative total of about 33 million, nearly half the global figure. At a WHO AFRO press briefing last Thursday, Gavi, The Vaccine Alliance, revealed it is working in Sierra Leone and Ghana to ensure that the millions of children and adolescent girls who missed out on vaccines during the pandemic are protected. “We’re very, very happy to be marking in a few days, the 2023 edition of the Africa Vaccination Week, and it’s a really good opportunity for us to take stock and to remind ourselves of what we have achieved but also what we are dealing with in terms of recovering from a pretty unprecedented emergency during the pandemic,” said Aurelia Nguyen, Gavi’s Chief Programme and Strategy Officer. Nguyen said that Gavi is working closely with its partners to support countries in making up lost ground and building stronger, more resilient systems. The efforts will focus on on hard-to-reach communities and implementing national programmes that are able to reach children and communities more effectively. Gavi is also focusing on the human papillomavirus (HPV) vaccine program, which was one of the hardest hit during the pandemic. With cervical cancer being the most common cause of cancer death in nearly half of sub-Saharan African countries, Nguyen noted that the HPV vaccine can prevent up to 90% of cervical cancer cases. So far, Gavi said it has supported 20 African countries to produce the HPV vaccine and received $600 million in extra investment last year to revitalize the program and strengthen health systems. “As we think about many, many challenges ahead, we also are considering the opportunities and we have a young and growing population, and so it’s really our responsibility and opportunity to make sure that we don’t leave any child behind with immunization,” said Nguyen. Additional reporting by Paul Adepoju. Image Credits: WHO / Billy Miaron. 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. 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Global Action Against Uganda’s Anti-Homosexuality Bill Amid Surge of Violent Attacks 25/04/2023 Kerry Cullinan Protestors in Washington DC. Protestors gathered outside Ugandan embassies worldwide on Tuesday for a global day of action against that country’s Anti-Homosexuality Bill, which criminalises all LGBTQ people and proposes a series of punishments ranging from fines to the death penalty. Violence against people suspected of being LGBTQ has already surged in the past month since Uganda’s Parliament passed the Bill with almost unanimous support. However, Ugandan President Yoweri Museveni declined last week to sign the Bill into law, sending it back to parliament last week with the instruction that it be “reinforced and strengthened”. While Museveni also congratulated MPs for rejecting “the pressure from imperialists”, he has been under intense pressure from the United Nations, US and European Union members not to sign the Bill. In addition, Uganda’s Deputy Attorney General has written to the Speaker highlighting why the Bill is unconstitutional, particularly focusing on the death penalty clauses. SOUND ON 🔊: President @KagutaMuseveni speaks about the Anti-Homosexuality Bill. pic.twitter.com/aXvU0YCplN — State House Uganda (@StateHouseUg) April 24, 2023 Since the Bill was passed a month ago, hate crimes and violence against LGBTQ people have risen sharply, according to the Human Rights and Awareness and Promotion Forum (HRAPF), a legal aid organisation. HIV services have also been affected, with some LGBTQ patients being afraid to attend clinics for fear of being arrested, according to The Lancet. In the past month, HRAPF has handled 59 cases involving LGBTQ or suspected LGBTQ persons. Forty of these cases “involved violence and violations targeting the victims purely on the basis of their presumed sexuality, and affected a total of 85 persons”. There is an exponential increase in cases of violence and violations against LGBTI persons fueled by the politicisation around the Anti Homosexuality Bill 2023 Read HRAPF’s report here>>> https://t.co/2Gre5T01Uh pic.twitter.com/lWSIQxNkcZ — HRAPF (@hrapf_uganda) April 24, 2023 “In one of these cases, a group of six people were arrested and charged with having carnal knowledge against the order of nature because the area local chairperson saw a video from a gay porn site in which one of the actors looked like one of the victims,” according to HRAPF, which itself faces fines simply for assisting LGBTQ clients. “In the most recent case, an athlete who was suspected to be a transgender woman was arrested by a mob, forcefully undressed and then forced to march through the streets naked while the crowd heckled her, threw objects at her, took her photos/ videos and even fondled her.” Meanwhile, a report released on Monday points out that Western governments and aid agencies – including the UK, Dutch, Norwegian and US governments – have donated $40 million to Ugandan anti-LGBTQ religious groups such as the Inter-Religious Council of Uganda since 2014. While the report acknowledges that there is no evidence “that any of this money specifically paid for anti-LGBTQI activities”, it adds that the aid and partnerships “can boost groups’ credibility, their reputations, and their access to power and other finance”. Kenya follows Uganda A Kenyan Member of Parliament, Peter Kaluma, has tabled an almost identical Bill to his parliament shortly after returning from a meeting in Uganda where leaders of a US anti-LGBTQ group, Family Watch International (FWI), delivered keynote addresses. FWI has a long history of involvement in anti-LGBTQ activities in Africa and was involved in promoting the forerunner of the current Uganda Bill, the so-called “kill the gays” Bill passed in 2014 but stopped by the courts on a technicality. FWI founder and leader Sharon Slater has doggedly pursued an anti-LGBT agenda for years, making a wide variety of claims including that LGBT people are more likely to be paedophiles. Slater, has also played a hand in the extreme anti-LGBTQ Bill before Ghana’s parliament. I recently had the honor of meeting with Ms. Sharon Slater, President of Family Watch International, & her team. They attended the first African Regional Inter-Parliamentary Conference in Uganda, focusing on global challenges that threaten African families & values. pic.twitter.com/8RP8ba4sLJ — Janet K Museveni (@JanetMuseveni) April 4, 2023 Slater, a Mormon from Arizona, has also been campaigning for years for African governments to ban comprehensive sexuality education in schools. A proponent of “conversion therapy”, a discredited approach that aims to change a person’s sexuality, Slater has apparently convinced Museveni that such ‘therapy’ should be promoted in the Bill to encourage people to renounce their homosexuality. Family Watch International’s Sharon Slater addresing Ugandan politicians Geopolitical complications While the Anti-Homosexuality Bill has drawn condemnation from European governments and the US, this has been muted as Western governments are in a race to woo African governments away from Russia and China. Russia also persecutes LGBTQ people and has a similar anti-rights agenda as Uganda. Meanwhile, South Africa, which outlaws discrimination against citizens on the basis of sexual orientation, is the only African country to mount protests against the Bill. The opposition Economic Freedom Fighters, which has significant youth support, has marched to the Ugandan Embassy in Pretoria. Meanwhile, on Tuesday the Secretary General of the ruling African National Congress said that discrimination and persecution were against the African Charter, and called on all states to “ensure that their citizens enjoy their full human rights”. Trump Politicisation of COVID Was a ‘Comorbidity’ in Disappointing US Pandemic Response 25/04/2023 Megha Kaveri President Donald Trump listens as Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, speaks to the press in 2020. An expert investigation into the US response to the COVID-19 pandemic has concluded that the country’s performance was the most disappointing in the world. The investigation’s report was launched on Tuesday as a book, Lessons from the COVID War, providing an in-depth analysis of America’s response to the pandemic and the aftermath by the COVID Crisis Group, an independent group of experts. No country’s performance in dealing with the pandemic was more disappointing than that of the US, according to the group. They came to this conclusion as the US excess deaths during the pandemic were around 40% higher than that of Europe, despite the US possessing deeper scientific knowledge about the virus and spending trillions of dollars to address it. Donald Trump’s politicking during the start of the pandemic when he was president is heavily criticised, with the authors concluding that his politicisation of the pandemic was a “comorbidity”. The book also examines the race to develop an effective vaccine against COVID-19 (Operation Warp Speed), COVID origins and the policies adopted by the federal and state governments. The COVID Crisis Group was born in 2021 out of a need to analyse the country’s COVID-19 response given that the pandemic killed more Americans than all US wars combined since the US War of Independence. The group consisted of 34 members – physicians, public health and policy experts led by Philp Zelikow, who led the official commission that looked into the 9/11 attacks. Lab-leak theory The report examines both the lab leak theory and the animal-human transmission theory of COVID-19, but doesn’t support either of these due to lack of sufficient evidence in both cases. The origins of COVID-19 has been a controversial topic as some believe that the virus might have broken out into the general population from the high-security laboratory that conducts research on coronaviruses at the Wuhan Institute of Virology in China. However, this theory has been disputed by many other eminent scientists and the World Health Organization (WHO), who believe that COVID-19 might have originated from a spillover event at a wet market in Wuhan province. The book comes down heavily on the US Centers for Disease Prevention and Control (CDC) and says that the agency took on a reactive role in a pandemic instead of proactively leading the way. Elaborating on the activities that went behind the development of successful mRNA vaccines against COVID, the book says that both Pfizer and Moderna enjoyed tremendous support from the federal government, either through upfront investment into development or as advance purchase guarantees that ran to billions of US dollars. It also emphasises how “Operation Warp Speed”, as it was known then, was a success only because of a perfect alignment of many other factors around it. Image Credits: flickr/The White House. Official White House Photo by Andrea Hanks. Africa to Manufacture New Malaria Vaccine? 24/04/2023 Paul Adepoju A healthcare worker gives a child a dose of the world’s first malaria vaccine, RTS,S. A second malaria vaccine has now been approved. IBADAN, Nigeria – There are high hopes that the R21/Matrix-M malaria vaccine recently approved by Ghana and Nigeria will be manufactured in Africa in the not-to-distant future – a brighter-than-usual prospect for this World Malaria Day (25 April). Earlier this month, Ghana’s Food and Drugs Authority (FDA) approved the R21/Matrix-M malaria vaccine manufactured by the Serum Institute of India (SII) for use in children aged from five months to three years, the age group at the highest risk of death from malaria. This was despite the vaccine not yet being given World Health Organization (WHO) prequalification approval. SII, the manufacturing and commercialisation license holder for the vaccine, described Ghana’s approval as the “first crucial step [that] will enable the vaccine to help Ghanaian and African children to effectively combat malaria”. “The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives,” said Adar Poonawalla, SII CEO. Shortly afterwards, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) also granted a “registration approval” for the vaccine to SII. The agency said it had received the dossier of the vaccine and it had been subjected to independent review at two levels. The agency added that the vaccine’s dossier substantially complied with best international standards, and that its Joint Review Committee had concluded the vaccine data was robust and met the criteria for efficacy, safety, and quality. Local production? Ghana’s regulator announced that the application for regulatory approval had been submitted by SII’s ‘local agent’, DEK, which expects to eventually manufacture the vaccine locally. “The status of the [Ghana] FDA Lab creates a great advantage for the local agent who hopefully will be manufacturing the malaria vaccine in Ghana in the near future,” the agency stated. A few days after the regulatory approval, a ground-breaking ceremony of the DEK Vaccines Limited’s vaccine fill-and-finish plant was held. The company is a private sector-led consortium of Ghanaian pharmaceutical companies. At the ceremony, Ghanaian President Nana Addo Dankwa Akufo-Addo, said it “will help our nation realise the dream of becoming self-sufficient in the manufacture of vaccines”. Meanwhile, Nigeria’s regulator announced Fidson Healthcare Ltd, a major local bourse-listed player in the country’s pharmaceutical industry, as the vaccine’s Marketing Authorization Holder (MAH). This authorizes the Nigerian firm licensed to distribute, sell and commercialize the vaccine in Nigeria. The Nigerian government also revealed in September 2022 that it had signed a local vaccine manufacturing agreement involving Biovaccines Nigeria Limited (a joint venture between the Federal Government of Nigeria and May & Baker Nigeria Plc), and SII. “The government has approved 15% of the vaccines that UNICEF normally supplies to Biovaccines to supply through contract manufacturing with the Serum Institute of India. With that, the institute will now be comfortable enough to come and join Biovaccines Nigeria in building its manufacturing plant here in Nigeria in Ota,” Nigerian health minister, Osagie Ehanire said. From Oxford to West Africa via India An infant receiving the RTS,S malaria vaccine in Ghana in 2019. Designed and developed at the University of Oxford, the vaccine has been tested in the United Kingdom, Thailand, and several African countries. A Phase Three trial that is underway in Burkina Faso, Kenya, Mali and Tanzania has enrolled 4,800 children and the results are expected later this year. While the regulator in Nigeria has also recommended an in-country Phase Four clinical trial or pharmacovigilance study in the implementation, given the peculiarity and heterogeneous nature of malaria in Nigeria, it noted that the efficacy results from the vaccine’s clinical trials contributed to its decision to approve it. Last year, the Oxford researchers and their partners reported from a Phase 2B trial that a booster dose of R21/Matrix-M at one year, following a primary three-dose regime, maintained high efficacy against malaria, and continued to meet the WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. This followed 2021 results from the Phase 2B trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77%. Recent data from the large phase III trial also show high levels of efficacy and a reassuring safety profile. Prof Adrian Hill, chief investigator for R21/Matrix-M programme, and Director of the Jenner Institute at the University of Oxford, described the regulatory approval of the vaccine as the culmination of 30 years of malaria vaccine research at Oxford. “I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children,” Hill said. The vaccine contains Novavax’s Matrix-M which is a saponin-based adjuvant that enhances the immune system response, making it more potent and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This technology has also been used successfully in Novavax’s COVID-19 vaccine and is a key component of other development-stage vaccines. An approval without a WHO prequalification Unlike the developments surrounding the approval of the COVID-19 vaccines in the African countries that largely followed a prequalification approval by the WHO, both Ghana and Nigerian regulators went ahead to approve the vaccine without any WHO approval. In addition to affirming their regulators’ competence and authorization to undertake such approvals, Dr Franklin Asiedu–Bekoe, Director of Public Health in Ghana, told Health Policy Watch that the vaccine – the second malaria vaccine that the country is rolling out – will be closely reviewed by the country’s team of scientists. “In Ghana, we have 93 districts that are now using the TRS,S. There are a number of districts that are yet to be using it. So if we have a vaccine, which is good, I think nothing stops us from using it,” he argued. Moreover, Prof William K. Ampofo, Secretary of the Presidential Committee on Vaccine Manufacturing and Development, Ghana, added that the approval was in response to the manufacturer’s application. “The vaccine was approved based on the application by the manufacturer Serum Institute. It was not an independent decision by the Ghana FDA. It was in response to the application by the Serum Institute for the R21 vaccine based on the data that had been accumulated,” Ampofo told Health Policy Watch. Local manufacturing elements of both approvals In the weeks before regulatory approval for the R21 vaccine, Ghana officially expanded access to the WHO-approved RTS,S malaria vaccine. Four years on, more than 4.5 million doses of the vaccine have been administered through the countries’ routine immunization programmes. “Community demand for the vaccine is high and the vaccine is well accepted in African communities, even when additional visits to vaccination clinics are required to receive the four-dose schedule,” WHO revealed. But RTS,S rollout has been plagued with concerns regarding its comparatively minimal efficacy, high cost and limited supply. In sharp contrast, R21’s demonstrably higher efficacy (more than 75% over 12 months) and comparatively lower cost ($3 compared with RTS,S’ $5 per dose) made it even more attractive to African countries – along with the manufacturer’s announcement of potential manufacturing capacities of more than 200 million doses annually. But beyond these essential factors are also considerations for local manufacturing from the outset of the vaccine’s introduction in Africa. WHO and Gavi falling in line Even though the WHO prequalification certification has not yet approved the R21 vaccine, the WHO has expressed its support for the vaccine, acknowledging on its website that a second malaria vaccine may be coming forward. “The WHO prequalification process is also underway. WHO will continue the thorough and efficient review of the R21 vaccine and awaits the submission of additional analyses by the vaccine developer,” the global health body said. Dr Phionah Atuhebwe, New Vaccines Introduction Officer at WHO AFRO Regional Office, added that the WHO is already evaluating the vaccine’s safety, efficacy, quality and programmatic suitability. “Ghana and Nigeria have not jumped the gun because it is expected that, at national level within their jurisdiction, the national regulatory authorities can also review data once they have received information from different vaccine developers,” she said. Gavi’s Aurelia Nguyen Aurelia Nguyen, Chief Programme and Strategy Officer for Gavi, the Vaccine Alliance, also told Health Policy Watch that the alliance is prepared to provide funding for the R21 malaria vaccine. “It is a hugely exciting development with the approvals that we’ve seen in Ghana and Nigeria. This is all moving us forward towards having a second vaccine,” Nguyen said. She noted that the restricted supply of the RTS,S made it “really important” to have several tools, in addition to affordability. “It’s not just about the volumes, it’s also about the affordability. Serum Institute has made a very important public commitment in terms of keeping the cost of the vaccines to $3 or less. So we really look forward to them honoring that commitment because ultimately, it will mean that more people are protected,” Nguyen concluded. Image Credits: WHO/Fanjan Combrink, WHO/M. Nieuwenhof, WHO. Powerful Partnership to Address Backslide in Childhood Vaccinations – But No Extra Funds 24/04/2023 Stefan Anderson “No child should die of a vaccine-preventable disease,” said WHO Director-General Tedros Adhanom Ghebreyesus. The world’s largest global health organizations have announced a partnership to reverse the years-long backslide in global childhood vaccination rates caused by the COVID-19 pandemic. An estimated 67 million children missed at least one essential vaccination between 2019 and 2021 and 50 million of these didn’t receive any vaccines – setting back childhood vaccination rates to their lowest level since 2008. But the “Big Catch-Up”, billed as an “extended effort” to restore vaccination levels in children to at least pre-pandemic levels and shore up essential health services for immunization programmes, does not contain any new financial commitments. Participants include the World Health Organization (WHO), UNICEF, the vaccine alliance Gavi, the Bill & Melinda Gates Foundation and a number of national and global health organizations. In the past three years, the overburdening and disruption of health services by COVID-19 containment efforts eroded over a decade of gains in routine childhood immunization levels. The vaccination schedules of millions of children around the world were knocked-off course, exposing them to life-threatening viruses that can be prevented by existing vaccines. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters the “Big Catch-Up” partnership does not involve any new financial commitments to bolster global childhood vaccination efforts. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters on Monday that preliminary estimates indicate that the backslide in childhood vaccinations has led to “at least” a five percent increase in mortality among children. “Every one of these lives that are lost is on top of the mortality that already exists because of the imperfection of the coverage and immunization programmes,” O’Brien said. “There will continue to be these children who are at risk going forward unless they are caught up.” Over 100 countries recorded declines in childhood vaccination rates during the pandemic, but three-quarters of the 25 million children who missed vaccinations in 2021 live in just 20 low- and middle-income countries. These will be a “particular focus” for the global coalition. “Millions of children and adolescents, particularly in lower-income countries, have missed out on life-saving vaccinations, while outbreaks of these deadly [preventable] diseases have risen,” said WHO director-general Tedros Adhanom Ghebreyesus. “Catching up is a top priority. No child should die of a vaccine-preventable disease.” Inequality is still behind vaccine access When UNICEF first began tracking childhood vaccination rates in 1980, just one in 10 children in the world’s poorest countries would “ever see a trained health worker or be immunized” before their first birthday. By the start of the next decade, seven in 10 children around the world were protected by vaccines – rising steadily to a height of 86% in 2019. Despite decades of progress, the story of children not receiving essential childhood vaccines remains one of inequality and poverty. One in five children in the world’s poorest households today are ‘zero-dose’, meaning they have never received a vaccine of any kind, according to UNICEF’s 2023 State of the World’s Children report released last week. In West and Central Africa, that number rises to nearly one in two, compared to one in 20 in the wealthiest countries. “Routine vaccines are typically a child’s first entry into their health system and so children who miss out on their early vaccines are at added risk of being cut out of healthcare in the long run,” UNICEF executive director Catherine Russel said. “The longer we wait to reach and vaccinate these children, the more vulnerable they become and the greater the risk of more deadly disease outbreaks.” Asked about the role of vaccine scepticism in dropping child vaccination rates, O’Brien stressed that while the global proliferation of misinformation around vaccines is “deeply concerning” – UNICEF found vaccine confidence dropped in 52 out of 55 countries – it remains a minor factor compared to income. “The main reason that kids are unvaccinated is not anti-vax [beliefs],” O’Brien said. “The main reason why children are unvaccinated has to do with access to services, quality of services, and the full availability of programmes.” Big ambitions, no extra funding No new funding to support the goal of returning childhood vaccination rates to pre-pandemic levels is included as part of the “Big Catch-Up”. “We’ve done an assessment of the resources that are out there, and we do feel that the resources are there,” O’Brien. “There are substantial resources already in-country and still available to countries through many different mechanisms.” Meanwhile, Medecins sans Frontieres (MSF) highlighted that children in conflict zones were particularly affected. “Despite the progress made in expanding global vaccination coverage, nearly 11 million of the un- and under-vaccinated infants live in fragile or humanitarian settings, including countries affected by conflict, and remain the most vulnerable to disease outbreaks,” said Dr Sharmila Shetty, Vaccines Medical Advisor for MSF’s Access Campaign. Africa’s burden According to estimates by WHO and UNICEF, the number of zero-dose and under-immunized African children rose by 16% between 2019 and 2021 to a cumulative total of about 33 million, nearly half the global figure. At a WHO AFRO press briefing last Thursday, Gavi, The Vaccine Alliance, revealed it is working in Sierra Leone and Ghana to ensure that the millions of children and adolescent girls who missed out on vaccines during the pandemic are protected. “We’re very, very happy to be marking in a few days, the 2023 edition of the Africa Vaccination Week, and it’s a really good opportunity for us to take stock and to remind ourselves of what we have achieved but also what we are dealing with in terms of recovering from a pretty unprecedented emergency during the pandemic,” said Aurelia Nguyen, Gavi’s Chief Programme and Strategy Officer. Nguyen said that Gavi is working closely with its partners to support countries in making up lost ground and building stronger, more resilient systems. The efforts will focus on on hard-to-reach communities and implementing national programmes that are able to reach children and communities more effectively. Gavi is also focusing on the human papillomavirus (HPV) vaccine program, which was one of the hardest hit during the pandemic. With cervical cancer being the most common cause of cancer death in nearly half of sub-Saharan African countries, Nguyen noted that the HPV vaccine can prevent up to 90% of cervical cancer cases. So far, Gavi said it has supported 20 African countries to produce the HPV vaccine and received $600 million in extra investment last year to revitalize the program and strengthen health systems. “As we think about many, many challenges ahead, we also are considering the opportunities and we have a young and growing population, and so it’s really our responsibility and opportunity to make sure that we don’t leave any child behind with immunization,” said Nguyen. Additional reporting by Paul Adepoju. Image Credits: WHO / Billy Miaron. 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. 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Trump Politicisation of COVID Was a ‘Comorbidity’ in Disappointing US Pandemic Response 25/04/2023 Megha Kaveri President Donald Trump listens as Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, speaks to the press in 2020. An expert investigation into the US response to the COVID-19 pandemic has concluded that the country’s performance was the most disappointing in the world. The investigation’s report was launched on Tuesday as a book, Lessons from the COVID War, providing an in-depth analysis of America’s response to the pandemic and the aftermath by the COVID Crisis Group, an independent group of experts. No country’s performance in dealing with the pandemic was more disappointing than that of the US, according to the group. They came to this conclusion as the US excess deaths during the pandemic were around 40% higher than that of Europe, despite the US possessing deeper scientific knowledge about the virus and spending trillions of dollars to address it. Donald Trump’s politicking during the start of the pandemic when he was president is heavily criticised, with the authors concluding that his politicisation of the pandemic was a “comorbidity”. The book also examines the race to develop an effective vaccine against COVID-19 (Operation Warp Speed), COVID origins and the policies adopted by the federal and state governments. The COVID Crisis Group was born in 2021 out of a need to analyse the country’s COVID-19 response given that the pandemic killed more Americans than all US wars combined since the US War of Independence. The group consisted of 34 members – physicians, public health and policy experts led by Philp Zelikow, who led the official commission that looked into the 9/11 attacks. Lab-leak theory The report examines both the lab leak theory and the animal-human transmission theory of COVID-19, but doesn’t support either of these due to lack of sufficient evidence in both cases. The origins of COVID-19 has been a controversial topic as some believe that the virus might have broken out into the general population from the high-security laboratory that conducts research on coronaviruses at the Wuhan Institute of Virology in China. However, this theory has been disputed by many other eminent scientists and the World Health Organization (WHO), who believe that COVID-19 might have originated from a spillover event at a wet market in Wuhan province. The book comes down heavily on the US Centers for Disease Prevention and Control (CDC) and says that the agency took on a reactive role in a pandemic instead of proactively leading the way. Elaborating on the activities that went behind the development of successful mRNA vaccines against COVID, the book says that both Pfizer and Moderna enjoyed tremendous support from the federal government, either through upfront investment into development or as advance purchase guarantees that ran to billions of US dollars. It also emphasises how “Operation Warp Speed”, as it was known then, was a success only because of a perfect alignment of many other factors around it. Image Credits: flickr/The White House. Official White House Photo by Andrea Hanks. Africa to Manufacture New Malaria Vaccine? 24/04/2023 Paul Adepoju A healthcare worker gives a child a dose of the world’s first malaria vaccine, RTS,S. A second malaria vaccine has now been approved. IBADAN, Nigeria – There are high hopes that the R21/Matrix-M malaria vaccine recently approved by Ghana and Nigeria will be manufactured in Africa in the not-to-distant future – a brighter-than-usual prospect for this World Malaria Day (25 April). Earlier this month, Ghana’s Food and Drugs Authority (FDA) approved the R21/Matrix-M malaria vaccine manufactured by the Serum Institute of India (SII) for use in children aged from five months to three years, the age group at the highest risk of death from malaria. This was despite the vaccine not yet being given World Health Organization (WHO) prequalification approval. SII, the manufacturing and commercialisation license holder for the vaccine, described Ghana’s approval as the “first crucial step [that] will enable the vaccine to help Ghanaian and African children to effectively combat malaria”. “The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives,” said Adar Poonawalla, SII CEO. Shortly afterwards, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) also granted a “registration approval” for the vaccine to SII. The agency said it had received the dossier of the vaccine and it had been subjected to independent review at two levels. The agency added that the vaccine’s dossier substantially complied with best international standards, and that its Joint Review Committee had concluded the vaccine data was robust and met the criteria for efficacy, safety, and quality. Local production? Ghana’s regulator announced that the application for regulatory approval had been submitted by SII’s ‘local agent’, DEK, which expects to eventually manufacture the vaccine locally. “The status of the [Ghana] FDA Lab creates a great advantage for the local agent who hopefully will be manufacturing the malaria vaccine in Ghana in the near future,” the agency stated. A few days after the regulatory approval, a ground-breaking ceremony of the DEK Vaccines Limited’s vaccine fill-and-finish plant was held. The company is a private sector-led consortium of Ghanaian pharmaceutical companies. At the ceremony, Ghanaian President Nana Addo Dankwa Akufo-Addo, said it “will help our nation realise the dream of becoming self-sufficient in the manufacture of vaccines”. Meanwhile, Nigeria’s regulator announced Fidson Healthcare Ltd, a major local bourse-listed player in the country’s pharmaceutical industry, as the vaccine’s Marketing Authorization Holder (MAH). This authorizes the Nigerian firm licensed to distribute, sell and commercialize the vaccine in Nigeria. The Nigerian government also revealed in September 2022 that it had signed a local vaccine manufacturing agreement involving Biovaccines Nigeria Limited (a joint venture between the Federal Government of Nigeria and May & Baker Nigeria Plc), and SII. “The government has approved 15% of the vaccines that UNICEF normally supplies to Biovaccines to supply through contract manufacturing with the Serum Institute of India. With that, the institute will now be comfortable enough to come and join Biovaccines Nigeria in building its manufacturing plant here in Nigeria in Ota,” Nigerian health minister, Osagie Ehanire said. From Oxford to West Africa via India An infant receiving the RTS,S malaria vaccine in Ghana in 2019. Designed and developed at the University of Oxford, the vaccine has been tested in the United Kingdom, Thailand, and several African countries. A Phase Three trial that is underway in Burkina Faso, Kenya, Mali and Tanzania has enrolled 4,800 children and the results are expected later this year. While the regulator in Nigeria has also recommended an in-country Phase Four clinical trial or pharmacovigilance study in the implementation, given the peculiarity and heterogeneous nature of malaria in Nigeria, it noted that the efficacy results from the vaccine’s clinical trials contributed to its decision to approve it. Last year, the Oxford researchers and their partners reported from a Phase 2B trial that a booster dose of R21/Matrix-M at one year, following a primary three-dose regime, maintained high efficacy against malaria, and continued to meet the WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. This followed 2021 results from the Phase 2B trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77%. Recent data from the large phase III trial also show high levels of efficacy and a reassuring safety profile. Prof Adrian Hill, chief investigator for R21/Matrix-M programme, and Director of the Jenner Institute at the University of Oxford, described the regulatory approval of the vaccine as the culmination of 30 years of malaria vaccine research at Oxford. “I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children,” Hill said. The vaccine contains Novavax’s Matrix-M which is a saponin-based adjuvant that enhances the immune system response, making it more potent and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This technology has also been used successfully in Novavax’s COVID-19 vaccine and is a key component of other development-stage vaccines. An approval without a WHO prequalification Unlike the developments surrounding the approval of the COVID-19 vaccines in the African countries that largely followed a prequalification approval by the WHO, both Ghana and Nigerian regulators went ahead to approve the vaccine without any WHO approval. In addition to affirming their regulators’ competence and authorization to undertake such approvals, Dr Franklin Asiedu–Bekoe, Director of Public Health in Ghana, told Health Policy Watch that the vaccine – the second malaria vaccine that the country is rolling out – will be closely reviewed by the country’s team of scientists. “In Ghana, we have 93 districts that are now using the TRS,S. There are a number of districts that are yet to be using it. So if we have a vaccine, which is good, I think nothing stops us from using it,” he argued. Moreover, Prof William K. Ampofo, Secretary of the Presidential Committee on Vaccine Manufacturing and Development, Ghana, added that the approval was in response to the manufacturer’s application. “The vaccine was approved based on the application by the manufacturer Serum Institute. It was not an independent decision by the Ghana FDA. It was in response to the application by the Serum Institute for the R21 vaccine based on the data that had been accumulated,” Ampofo told Health Policy Watch. Local manufacturing elements of both approvals In the weeks before regulatory approval for the R21 vaccine, Ghana officially expanded access to the WHO-approved RTS,S malaria vaccine. Four years on, more than 4.5 million doses of the vaccine have been administered through the countries’ routine immunization programmes. “Community demand for the vaccine is high and the vaccine is well accepted in African communities, even when additional visits to vaccination clinics are required to receive the four-dose schedule,” WHO revealed. But RTS,S rollout has been plagued with concerns regarding its comparatively minimal efficacy, high cost and limited supply. In sharp contrast, R21’s demonstrably higher efficacy (more than 75% over 12 months) and comparatively lower cost ($3 compared with RTS,S’ $5 per dose) made it even more attractive to African countries – along with the manufacturer’s announcement of potential manufacturing capacities of more than 200 million doses annually. But beyond these essential factors are also considerations for local manufacturing from the outset of the vaccine’s introduction in Africa. WHO and Gavi falling in line Even though the WHO prequalification certification has not yet approved the R21 vaccine, the WHO has expressed its support for the vaccine, acknowledging on its website that a second malaria vaccine may be coming forward. “The WHO prequalification process is also underway. WHO will continue the thorough and efficient review of the R21 vaccine and awaits the submission of additional analyses by the vaccine developer,” the global health body said. Dr Phionah Atuhebwe, New Vaccines Introduction Officer at WHO AFRO Regional Office, added that the WHO is already evaluating the vaccine’s safety, efficacy, quality and programmatic suitability. “Ghana and Nigeria have not jumped the gun because it is expected that, at national level within their jurisdiction, the national regulatory authorities can also review data once they have received information from different vaccine developers,” she said. Gavi’s Aurelia Nguyen Aurelia Nguyen, Chief Programme and Strategy Officer for Gavi, the Vaccine Alliance, also told Health Policy Watch that the alliance is prepared to provide funding for the R21 malaria vaccine. “It is a hugely exciting development with the approvals that we’ve seen in Ghana and Nigeria. This is all moving us forward towards having a second vaccine,” Nguyen said. She noted that the restricted supply of the RTS,S made it “really important” to have several tools, in addition to affordability. “It’s not just about the volumes, it’s also about the affordability. Serum Institute has made a very important public commitment in terms of keeping the cost of the vaccines to $3 or less. So we really look forward to them honoring that commitment because ultimately, it will mean that more people are protected,” Nguyen concluded. Image Credits: WHO/Fanjan Combrink, WHO/M. Nieuwenhof, WHO. Powerful Partnership to Address Backslide in Childhood Vaccinations – But No Extra Funds 24/04/2023 Stefan Anderson “No child should die of a vaccine-preventable disease,” said WHO Director-General Tedros Adhanom Ghebreyesus. The world’s largest global health organizations have announced a partnership to reverse the years-long backslide in global childhood vaccination rates caused by the COVID-19 pandemic. An estimated 67 million children missed at least one essential vaccination between 2019 and 2021 and 50 million of these didn’t receive any vaccines – setting back childhood vaccination rates to their lowest level since 2008. But the “Big Catch-Up”, billed as an “extended effort” to restore vaccination levels in children to at least pre-pandemic levels and shore up essential health services for immunization programmes, does not contain any new financial commitments. Participants include the World Health Organization (WHO), UNICEF, the vaccine alliance Gavi, the Bill & Melinda Gates Foundation and a number of national and global health organizations. In the past three years, the overburdening and disruption of health services by COVID-19 containment efforts eroded over a decade of gains in routine childhood immunization levels. The vaccination schedules of millions of children around the world were knocked-off course, exposing them to life-threatening viruses that can be prevented by existing vaccines. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters the “Big Catch-Up” partnership does not involve any new financial commitments to bolster global childhood vaccination efforts. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters on Monday that preliminary estimates indicate that the backslide in childhood vaccinations has led to “at least” a five percent increase in mortality among children. “Every one of these lives that are lost is on top of the mortality that already exists because of the imperfection of the coverage and immunization programmes,” O’Brien said. “There will continue to be these children who are at risk going forward unless they are caught up.” Over 100 countries recorded declines in childhood vaccination rates during the pandemic, but three-quarters of the 25 million children who missed vaccinations in 2021 live in just 20 low- and middle-income countries. These will be a “particular focus” for the global coalition. “Millions of children and adolescents, particularly in lower-income countries, have missed out on life-saving vaccinations, while outbreaks of these deadly [preventable] diseases have risen,” said WHO director-general Tedros Adhanom Ghebreyesus. “Catching up is a top priority. No child should die of a vaccine-preventable disease.” Inequality is still behind vaccine access When UNICEF first began tracking childhood vaccination rates in 1980, just one in 10 children in the world’s poorest countries would “ever see a trained health worker or be immunized” before their first birthday. By the start of the next decade, seven in 10 children around the world were protected by vaccines – rising steadily to a height of 86% in 2019. Despite decades of progress, the story of children not receiving essential childhood vaccines remains one of inequality and poverty. One in five children in the world’s poorest households today are ‘zero-dose’, meaning they have never received a vaccine of any kind, according to UNICEF’s 2023 State of the World’s Children report released last week. In West and Central Africa, that number rises to nearly one in two, compared to one in 20 in the wealthiest countries. “Routine vaccines are typically a child’s first entry into their health system and so children who miss out on their early vaccines are at added risk of being cut out of healthcare in the long run,” UNICEF executive director Catherine Russel said. “The longer we wait to reach and vaccinate these children, the more vulnerable they become and the greater the risk of more deadly disease outbreaks.” Asked about the role of vaccine scepticism in dropping child vaccination rates, O’Brien stressed that while the global proliferation of misinformation around vaccines is “deeply concerning” – UNICEF found vaccine confidence dropped in 52 out of 55 countries – it remains a minor factor compared to income. “The main reason that kids are unvaccinated is not anti-vax [beliefs],” O’Brien said. “The main reason why children are unvaccinated has to do with access to services, quality of services, and the full availability of programmes.” Big ambitions, no extra funding No new funding to support the goal of returning childhood vaccination rates to pre-pandemic levels is included as part of the “Big Catch-Up”. “We’ve done an assessment of the resources that are out there, and we do feel that the resources are there,” O’Brien. “There are substantial resources already in-country and still available to countries through many different mechanisms.” Meanwhile, Medecins sans Frontieres (MSF) highlighted that children in conflict zones were particularly affected. “Despite the progress made in expanding global vaccination coverage, nearly 11 million of the un- and under-vaccinated infants live in fragile or humanitarian settings, including countries affected by conflict, and remain the most vulnerable to disease outbreaks,” said Dr Sharmila Shetty, Vaccines Medical Advisor for MSF’s Access Campaign. Africa’s burden According to estimates by WHO and UNICEF, the number of zero-dose and under-immunized African children rose by 16% between 2019 and 2021 to a cumulative total of about 33 million, nearly half the global figure. At a WHO AFRO press briefing last Thursday, Gavi, The Vaccine Alliance, revealed it is working in Sierra Leone and Ghana to ensure that the millions of children and adolescent girls who missed out on vaccines during the pandemic are protected. “We’re very, very happy to be marking in a few days, the 2023 edition of the Africa Vaccination Week, and it’s a really good opportunity for us to take stock and to remind ourselves of what we have achieved but also what we are dealing with in terms of recovering from a pretty unprecedented emergency during the pandemic,” said Aurelia Nguyen, Gavi’s Chief Programme and Strategy Officer. Nguyen said that Gavi is working closely with its partners to support countries in making up lost ground and building stronger, more resilient systems. The efforts will focus on on hard-to-reach communities and implementing national programmes that are able to reach children and communities more effectively. Gavi is also focusing on the human papillomavirus (HPV) vaccine program, which was one of the hardest hit during the pandemic. With cervical cancer being the most common cause of cancer death in nearly half of sub-Saharan African countries, Nguyen noted that the HPV vaccine can prevent up to 90% of cervical cancer cases. So far, Gavi said it has supported 20 African countries to produce the HPV vaccine and received $600 million in extra investment last year to revitalize the program and strengthen health systems. “As we think about many, many challenges ahead, we also are considering the opportunities and we have a young and growing population, and so it’s really our responsibility and opportunity to make sure that we don’t leave any child behind with immunization,” said Nguyen. Additional reporting by Paul Adepoju. Image Credits: WHO / Billy Miaron. 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. 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Africa to Manufacture New Malaria Vaccine? 24/04/2023 Paul Adepoju A healthcare worker gives a child a dose of the world’s first malaria vaccine, RTS,S. A second malaria vaccine has now been approved. IBADAN, Nigeria – There are high hopes that the R21/Matrix-M malaria vaccine recently approved by Ghana and Nigeria will be manufactured in Africa in the not-to-distant future – a brighter-than-usual prospect for this World Malaria Day (25 April). Earlier this month, Ghana’s Food and Drugs Authority (FDA) approved the R21/Matrix-M malaria vaccine manufactured by the Serum Institute of India (SII) for use in children aged from five months to three years, the age group at the highest risk of death from malaria. This was despite the vaccine not yet being given World Health Organization (WHO) prequalification approval. SII, the manufacturing and commercialisation license holder for the vaccine, described Ghana’s approval as the “first crucial step [that] will enable the vaccine to help Ghanaian and African children to effectively combat malaria”. “The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives,” said Adar Poonawalla, SII CEO. Shortly afterwards, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) also granted a “registration approval” for the vaccine to SII. The agency said it had received the dossier of the vaccine and it had been subjected to independent review at two levels. The agency added that the vaccine’s dossier substantially complied with best international standards, and that its Joint Review Committee had concluded the vaccine data was robust and met the criteria for efficacy, safety, and quality. Local production? Ghana’s regulator announced that the application for regulatory approval had been submitted by SII’s ‘local agent’, DEK, which expects to eventually manufacture the vaccine locally. “The status of the [Ghana] FDA Lab creates a great advantage for the local agent who hopefully will be manufacturing the malaria vaccine in Ghana in the near future,” the agency stated. A few days after the regulatory approval, a ground-breaking ceremony of the DEK Vaccines Limited’s vaccine fill-and-finish plant was held. The company is a private sector-led consortium of Ghanaian pharmaceutical companies. At the ceremony, Ghanaian President Nana Addo Dankwa Akufo-Addo, said it “will help our nation realise the dream of becoming self-sufficient in the manufacture of vaccines”. Meanwhile, Nigeria’s regulator announced Fidson Healthcare Ltd, a major local bourse-listed player in the country’s pharmaceutical industry, as the vaccine’s Marketing Authorization Holder (MAH). This authorizes the Nigerian firm licensed to distribute, sell and commercialize the vaccine in Nigeria. The Nigerian government also revealed in September 2022 that it had signed a local vaccine manufacturing agreement involving Biovaccines Nigeria Limited (a joint venture between the Federal Government of Nigeria and May & Baker Nigeria Plc), and SII. “The government has approved 15% of the vaccines that UNICEF normally supplies to Biovaccines to supply through contract manufacturing with the Serum Institute of India. With that, the institute will now be comfortable enough to come and join Biovaccines Nigeria in building its manufacturing plant here in Nigeria in Ota,” Nigerian health minister, Osagie Ehanire said. From Oxford to West Africa via India An infant receiving the RTS,S malaria vaccine in Ghana in 2019. Designed and developed at the University of Oxford, the vaccine has been tested in the United Kingdom, Thailand, and several African countries. A Phase Three trial that is underway in Burkina Faso, Kenya, Mali and Tanzania has enrolled 4,800 children and the results are expected later this year. While the regulator in Nigeria has also recommended an in-country Phase Four clinical trial or pharmacovigilance study in the implementation, given the peculiarity and heterogeneous nature of malaria in Nigeria, it noted that the efficacy results from the vaccine’s clinical trials contributed to its decision to approve it. Last year, the Oxford researchers and their partners reported from a Phase 2B trial that a booster dose of R21/Matrix-M at one year, following a primary three-dose regime, maintained high efficacy against malaria, and continued to meet the WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. This followed 2021 results from the Phase 2B trial reporting that R21/Matrix-M demonstrated high-level efficacy of 77%. Recent data from the large phase III trial also show high levels of efficacy and a reassuring safety profile. Prof Adrian Hill, chief investigator for R21/Matrix-M programme, and Director of the Jenner Institute at the University of Oxford, described the regulatory approval of the vaccine as the culmination of 30 years of malaria vaccine research at Oxford. “I congratulate our superb clinical trial partners in Africa who have generated the dataset supporting the safety and efficacy of the vaccine in children,” Hill said. The vaccine contains Novavax’s Matrix-M which is a saponin-based adjuvant that enhances the immune system response, making it more potent and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. This technology has also been used successfully in Novavax’s COVID-19 vaccine and is a key component of other development-stage vaccines. An approval without a WHO prequalification Unlike the developments surrounding the approval of the COVID-19 vaccines in the African countries that largely followed a prequalification approval by the WHO, both Ghana and Nigerian regulators went ahead to approve the vaccine without any WHO approval. In addition to affirming their regulators’ competence and authorization to undertake such approvals, Dr Franklin Asiedu–Bekoe, Director of Public Health in Ghana, told Health Policy Watch that the vaccine – the second malaria vaccine that the country is rolling out – will be closely reviewed by the country’s team of scientists. “In Ghana, we have 93 districts that are now using the TRS,S. There are a number of districts that are yet to be using it. So if we have a vaccine, which is good, I think nothing stops us from using it,” he argued. Moreover, Prof William K. Ampofo, Secretary of the Presidential Committee on Vaccine Manufacturing and Development, Ghana, added that the approval was in response to the manufacturer’s application. “The vaccine was approved based on the application by the manufacturer Serum Institute. It was not an independent decision by the Ghana FDA. It was in response to the application by the Serum Institute for the R21 vaccine based on the data that had been accumulated,” Ampofo told Health Policy Watch. Local manufacturing elements of both approvals In the weeks before regulatory approval for the R21 vaccine, Ghana officially expanded access to the WHO-approved RTS,S malaria vaccine. Four years on, more than 4.5 million doses of the vaccine have been administered through the countries’ routine immunization programmes. “Community demand for the vaccine is high and the vaccine is well accepted in African communities, even when additional visits to vaccination clinics are required to receive the four-dose schedule,” WHO revealed. But RTS,S rollout has been plagued with concerns regarding its comparatively minimal efficacy, high cost and limited supply. In sharp contrast, R21’s demonstrably higher efficacy (more than 75% over 12 months) and comparatively lower cost ($3 compared with RTS,S’ $5 per dose) made it even more attractive to African countries – along with the manufacturer’s announcement of potential manufacturing capacities of more than 200 million doses annually. But beyond these essential factors are also considerations for local manufacturing from the outset of the vaccine’s introduction in Africa. WHO and Gavi falling in line Even though the WHO prequalification certification has not yet approved the R21 vaccine, the WHO has expressed its support for the vaccine, acknowledging on its website that a second malaria vaccine may be coming forward. “The WHO prequalification process is also underway. WHO will continue the thorough and efficient review of the R21 vaccine and awaits the submission of additional analyses by the vaccine developer,” the global health body said. Dr Phionah Atuhebwe, New Vaccines Introduction Officer at WHO AFRO Regional Office, added that the WHO is already evaluating the vaccine’s safety, efficacy, quality and programmatic suitability. “Ghana and Nigeria have not jumped the gun because it is expected that, at national level within their jurisdiction, the national regulatory authorities can also review data once they have received information from different vaccine developers,” she said. Gavi’s Aurelia Nguyen Aurelia Nguyen, Chief Programme and Strategy Officer for Gavi, the Vaccine Alliance, also told Health Policy Watch that the alliance is prepared to provide funding for the R21 malaria vaccine. “It is a hugely exciting development with the approvals that we’ve seen in Ghana and Nigeria. This is all moving us forward towards having a second vaccine,” Nguyen said. She noted that the restricted supply of the RTS,S made it “really important” to have several tools, in addition to affordability. “It’s not just about the volumes, it’s also about the affordability. Serum Institute has made a very important public commitment in terms of keeping the cost of the vaccines to $3 or less. So we really look forward to them honoring that commitment because ultimately, it will mean that more people are protected,” Nguyen concluded. Image Credits: WHO/Fanjan Combrink, WHO/M. Nieuwenhof, WHO. Powerful Partnership to Address Backslide in Childhood Vaccinations – But No Extra Funds 24/04/2023 Stefan Anderson “No child should die of a vaccine-preventable disease,” said WHO Director-General Tedros Adhanom Ghebreyesus. The world’s largest global health organizations have announced a partnership to reverse the years-long backslide in global childhood vaccination rates caused by the COVID-19 pandemic. An estimated 67 million children missed at least one essential vaccination between 2019 and 2021 and 50 million of these didn’t receive any vaccines – setting back childhood vaccination rates to their lowest level since 2008. But the “Big Catch-Up”, billed as an “extended effort” to restore vaccination levels in children to at least pre-pandemic levels and shore up essential health services for immunization programmes, does not contain any new financial commitments. Participants include the World Health Organization (WHO), UNICEF, the vaccine alliance Gavi, the Bill & Melinda Gates Foundation and a number of national and global health organizations. In the past three years, the overburdening and disruption of health services by COVID-19 containment efforts eroded over a decade of gains in routine childhood immunization levels. The vaccination schedules of millions of children around the world were knocked-off course, exposing them to life-threatening viruses that can be prevented by existing vaccines. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters the “Big Catch-Up” partnership does not involve any new financial commitments to bolster global childhood vaccination efforts. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters on Monday that preliminary estimates indicate that the backslide in childhood vaccinations has led to “at least” a five percent increase in mortality among children. “Every one of these lives that are lost is on top of the mortality that already exists because of the imperfection of the coverage and immunization programmes,” O’Brien said. “There will continue to be these children who are at risk going forward unless they are caught up.” Over 100 countries recorded declines in childhood vaccination rates during the pandemic, but three-quarters of the 25 million children who missed vaccinations in 2021 live in just 20 low- and middle-income countries. These will be a “particular focus” for the global coalition. “Millions of children and adolescents, particularly in lower-income countries, have missed out on life-saving vaccinations, while outbreaks of these deadly [preventable] diseases have risen,” said WHO director-general Tedros Adhanom Ghebreyesus. “Catching up is a top priority. No child should die of a vaccine-preventable disease.” Inequality is still behind vaccine access When UNICEF first began tracking childhood vaccination rates in 1980, just one in 10 children in the world’s poorest countries would “ever see a trained health worker or be immunized” before their first birthday. By the start of the next decade, seven in 10 children around the world were protected by vaccines – rising steadily to a height of 86% in 2019. Despite decades of progress, the story of children not receiving essential childhood vaccines remains one of inequality and poverty. One in five children in the world’s poorest households today are ‘zero-dose’, meaning they have never received a vaccine of any kind, according to UNICEF’s 2023 State of the World’s Children report released last week. In West and Central Africa, that number rises to nearly one in two, compared to one in 20 in the wealthiest countries. “Routine vaccines are typically a child’s first entry into their health system and so children who miss out on their early vaccines are at added risk of being cut out of healthcare in the long run,” UNICEF executive director Catherine Russel said. “The longer we wait to reach and vaccinate these children, the more vulnerable they become and the greater the risk of more deadly disease outbreaks.” Asked about the role of vaccine scepticism in dropping child vaccination rates, O’Brien stressed that while the global proliferation of misinformation around vaccines is “deeply concerning” – UNICEF found vaccine confidence dropped in 52 out of 55 countries – it remains a minor factor compared to income. “The main reason that kids are unvaccinated is not anti-vax [beliefs],” O’Brien said. “The main reason why children are unvaccinated has to do with access to services, quality of services, and the full availability of programmes.” Big ambitions, no extra funding No new funding to support the goal of returning childhood vaccination rates to pre-pandemic levels is included as part of the “Big Catch-Up”. “We’ve done an assessment of the resources that are out there, and we do feel that the resources are there,” O’Brien. “There are substantial resources already in-country and still available to countries through many different mechanisms.” Meanwhile, Medecins sans Frontieres (MSF) highlighted that children in conflict zones were particularly affected. “Despite the progress made in expanding global vaccination coverage, nearly 11 million of the un- and under-vaccinated infants live in fragile or humanitarian settings, including countries affected by conflict, and remain the most vulnerable to disease outbreaks,” said Dr Sharmila Shetty, Vaccines Medical Advisor for MSF’s Access Campaign. Africa’s burden According to estimates by WHO and UNICEF, the number of zero-dose and under-immunized African children rose by 16% between 2019 and 2021 to a cumulative total of about 33 million, nearly half the global figure. At a WHO AFRO press briefing last Thursday, Gavi, The Vaccine Alliance, revealed it is working in Sierra Leone and Ghana to ensure that the millions of children and adolescent girls who missed out on vaccines during the pandemic are protected. “We’re very, very happy to be marking in a few days, the 2023 edition of the Africa Vaccination Week, and it’s a really good opportunity for us to take stock and to remind ourselves of what we have achieved but also what we are dealing with in terms of recovering from a pretty unprecedented emergency during the pandemic,” said Aurelia Nguyen, Gavi’s Chief Programme and Strategy Officer. Nguyen said that Gavi is working closely with its partners to support countries in making up lost ground and building stronger, more resilient systems. The efforts will focus on on hard-to-reach communities and implementing national programmes that are able to reach children and communities more effectively. Gavi is also focusing on the human papillomavirus (HPV) vaccine program, which was one of the hardest hit during the pandemic. With cervical cancer being the most common cause of cancer death in nearly half of sub-Saharan African countries, Nguyen noted that the HPV vaccine can prevent up to 90% of cervical cancer cases. So far, Gavi said it has supported 20 African countries to produce the HPV vaccine and received $600 million in extra investment last year to revitalize the program and strengthen health systems. “As we think about many, many challenges ahead, we also are considering the opportunities and we have a young and growing population, and so it’s really our responsibility and opportunity to make sure that we don’t leave any child behind with immunization,” said Nguyen. Additional reporting by Paul Adepoju. Image Credits: WHO / Billy Miaron. 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
Powerful Partnership to Address Backslide in Childhood Vaccinations – But No Extra Funds 24/04/2023 Stefan Anderson “No child should die of a vaccine-preventable disease,” said WHO Director-General Tedros Adhanom Ghebreyesus. The world’s largest global health organizations have announced a partnership to reverse the years-long backslide in global childhood vaccination rates caused by the COVID-19 pandemic. An estimated 67 million children missed at least one essential vaccination between 2019 and 2021 and 50 million of these didn’t receive any vaccines – setting back childhood vaccination rates to their lowest level since 2008. But the “Big Catch-Up”, billed as an “extended effort” to restore vaccination levels in children to at least pre-pandemic levels and shore up essential health services for immunization programmes, does not contain any new financial commitments. Participants include the World Health Organization (WHO), UNICEF, the vaccine alliance Gavi, the Bill & Melinda Gates Foundation and a number of national and global health organizations. In the past three years, the overburdening and disruption of health services by COVID-19 containment efforts eroded over a decade of gains in routine childhood immunization levels. The vaccination schedules of millions of children around the world were knocked-off course, exposing them to life-threatening viruses that can be prevented by existing vaccines. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters the “Big Catch-Up” partnership does not involve any new financial commitments to bolster global childhood vaccination efforts. Dr Kate O’Brien, WHO director of immunization and vaccines, told reporters on Monday that preliminary estimates indicate that the backslide in childhood vaccinations has led to “at least” a five percent increase in mortality among children. “Every one of these lives that are lost is on top of the mortality that already exists because of the imperfection of the coverage and immunization programmes,” O’Brien said. “There will continue to be these children who are at risk going forward unless they are caught up.” Over 100 countries recorded declines in childhood vaccination rates during the pandemic, but three-quarters of the 25 million children who missed vaccinations in 2021 live in just 20 low- and middle-income countries. These will be a “particular focus” for the global coalition. “Millions of children and adolescents, particularly in lower-income countries, have missed out on life-saving vaccinations, while outbreaks of these deadly [preventable] diseases have risen,” said WHO director-general Tedros Adhanom Ghebreyesus. “Catching up is a top priority. No child should die of a vaccine-preventable disease.” Inequality is still behind vaccine access When UNICEF first began tracking childhood vaccination rates in 1980, just one in 10 children in the world’s poorest countries would “ever see a trained health worker or be immunized” before their first birthday. By the start of the next decade, seven in 10 children around the world were protected by vaccines – rising steadily to a height of 86% in 2019. Despite decades of progress, the story of children not receiving essential childhood vaccines remains one of inequality and poverty. One in five children in the world’s poorest households today are ‘zero-dose’, meaning they have never received a vaccine of any kind, according to UNICEF’s 2023 State of the World’s Children report released last week. In West and Central Africa, that number rises to nearly one in two, compared to one in 20 in the wealthiest countries. “Routine vaccines are typically a child’s first entry into their health system and so children who miss out on their early vaccines are at added risk of being cut out of healthcare in the long run,” UNICEF executive director Catherine Russel said. “The longer we wait to reach and vaccinate these children, the more vulnerable they become and the greater the risk of more deadly disease outbreaks.” Asked about the role of vaccine scepticism in dropping child vaccination rates, O’Brien stressed that while the global proliferation of misinformation around vaccines is “deeply concerning” – UNICEF found vaccine confidence dropped in 52 out of 55 countries – it remains a minor factor compared to income. “The main reason that kids are unvaccinated is not anti-vax [beliefs],” O’Brien said. “The main reason why children are unvaccinated has to do with access to services, quality of services, and the full availability of programmes.” Big ambitions, no extra funding No new funding to support the goal of returning childhood vaccination rates to pre-pandemic levels is included as part of the “Big Catch-Up”. “We’ve done an assessment of the resources that are out there, and we do feel that the resources are there,” O’Brien. “There are substantial resources already in-country and still available to countries through many different mechanisms.” Meanwhile, Medecins sans Frontieres (MSF) highlighted that children in conflict zones were particularly affected. “Despite the progress made in expanding global vaccination coverage, nearly 11 million of the un- and under-vaccinated infants live in fragile or humanitarian settings, including countries affected by conflict, and remain the most vulnerable to disease outbreaks,” said Dr Sharmila Shetty, Vaccines Medical Advisor for MSF’s Access Campaign. Africa’s burden According to estimates by WHO and UNICEF, the number of zero-dose and under-immunized African children rose by 16% between 2019 and 2021 to a cumulative total of about 33 million, nearly half the global figure. At a WHO AFRO press briefing last Thursday, Gavi, The Vaccine Alliance, revealed it is working in Sierra Leone and Ghana to ensure that the millions of children and adolescent girls who missed out on vaccines during the pandemic are protected. “We’re very, very happy to be marking in a few days, the 2023 edition of the Africa Vaccination Week, and it’s a really good opportunity for us to take stock and to remind ourselves of what we have achieved but also what we are dealing with in terms of recovering from a pretty unprecedented emergency during the pandemic,” said Aurelia Nguyen, Gavi’s Chief Programme and Strategy Officer. Nguyen said that Gavi is working closely with its partners to support countries in making up lost ground and building stronger, more resilient systems. The efforts will focus on on hard-to-reach communities and implementing national programmes that are able to reach children and communities more effectively. Gavi is also focusing on the human papillomavirus (HPV) vaccine program, which was one of the hardest hit during the pandemic. With cervical cancer being the most common cause of cancer death in nearly half of sub-Saharan African countries, Nguyen noted that the HPV vaccine can prevent up to 90% of cervical cancer cases. So far, Gavi said it has supported 20 African countries to produce the HPV vaccine and received $600 million in extra investment last year to revitalize the program and strengthen health systems. “As we think about many, many challenges ahead, we also are considering the opportunities and we have a young and growing population, and so it’s really our responsibility and opportunity to make sure that we don’t leave any child behind with immunization,” said Nguyen. Additional reporting by Paul Adepoju. Image Credits: WHO / Billy Miaron. Posts navigation Older postsNewer posts