One COVID Vaccine Jab After Recovery Cut Risk of Reinfection by Delta Variant Up to 82% 18/02/2022 Maayan Hoffman Individuals who recovered from COVID-19 and then received at least one shot of the Pfizer mRNA COVID-19 vaccine had a significantly lower risk of reinfection, according to a new study published Wednesday’s New England Journal of Medicine,. The study was conducted by researchers at Israel’s Clalit Health Services, in collaboration with Ben-Gurion University and Sapir Academic College. Specifically, the research showed there was an 82% reduction in the risk of reinfection with the virus among recovered and vaccinated 16- to 64-year-olds, and a 60% risk reduction among those aged 65 and older. Contrary to recommendations in some countries, however, the study also suggested that one shot was sufficient in preventing re-infection with two shots performing no better. “The results of our study unequivocally show that giving a coronavirus vaccine to people who have recovered is significantly associated with reducing the risk of re-infection,” said Dr. Doron Netzer of Clalit Health Services. However, she said the findings only covered peoples’ risks of re-infection during the Delta wave, and not necessarily Omicron. The latter variant has been less deadly but also more resistant to vaccine-induced protection. The researchers noted that the results were consistent with data from studies that have shown strong immunologic responses to vaccination in previously infected persons. Study applicable to Delta not Omicron The study was conducted from March 1, 2021, the date on which Israel’s Ministry of Health approved the vaccination of people who recovered from COVID-19, through November 26, 2021 – at the height of the Delta wave. Although the study thus only covers the Delta wave, it also provided an opportunity to draw out some general principals on COVID vaccines, the researchers said. “The surge of the Delta variant provided an epidemiologic opportunity to assess whether the vaccination of patients who had recovered from COVID-19 would provide extra protection against recurrent infection,” the researchers explained in their article. The team analyzed the data of Clalit patients using advanced statistical methods to test the effectiveness of the vaccine in preventing re-infection with the virus among Covid-recovered people who received the vaccine at least three months after being ill. their infection. They compared reinfection rates among patients who had subsequently received the vaccine and those who had not. Clalit is Israel’s largest health fund. In total, 149,032 people over the age of 16 who had recovered from coronavirus were included in the study – 83,356 who received at least one shot after infection. Reinfection occurred in 354 of the vaccinated patients (2.46 cases per 100,000 persons per day) and in 2,168 of the 65,676 unvaccinated patients (10.21 cases per 100,000 persons per day). “Although vaccine effectiveness was lower among patients who were 65 years of age or older than among younger patients, the vaccine still offered substantial protection among older patients,” the researchers wrote. “However, among the unvaccinated patients, the reinfection rate among the older patients was much lower than that among the younger patients (3.02 cases per 100,000 persons per day vs.10.79 cases per 100,000 persons per day). This observation may be explained if we assume that older patients who had already been infected with SARS-CoV-2 would have observed enhanced social distancing and other required precautions, especially during the surge of the Delta variant, even if they had decided against vaccination. “Therefore, the differences in reinfection rates between vaccinated and unvaccinated older patients were lower than those in the younger population,” they concluded. One dose is enough The research did not show a significant difference in vaccine effectiveness for one dose as compared with two doses. That is a striking finding in light of the fact that many countries required two COVID jabs, even among recovered people, after a certain interval of time, to gain access to COVID vaccine passes that facilitated entry to leisure sites and travel. Though in Israel, there was a one shot recommendation at the time of the study, and to date, people who have recovered and have received only one vaccine dose before or after recovery are eligible for the pass. “If you recovered from COVID-19, it is like you got a primary vaccination,” said Dr. Ronen Arbel, the senior researcher and the head of the Maximizing Health Outcomes Research Lab at Sapir Academic College. “It would be best to get vaccinated to boost the infection-induced immunity, but one shot is enough.” Image Credits: Maccabi Health Services. Noise, Wildfires, and Disruptive Timings of Life Cycles are Looming Environmental Threats, Warns UNEP Report 18/02/2022 Raisa Santos Ho Chi Minh City street traffic. The city is one of many that have surpassed acceptable noise levels. Urban noise pollution, wildfires, and disruptions of life cycles in natural systems are all growing environmental problems with ecological consequences that require greater attention, according to the new Frontier Report published Thursday by the UN Environment Programme (UNEP). The fourth edition of the report, ‘Noises, Blazes and Mismatches: Emerging Issues of Environmental Concern’, was released days before the resumed fifth session of the UN Environment Assembly (UNEA), to start on 28 February – 2 March. The report was first published in 2016 with an alert to the growing risk of zoonotic diseases, four years before the outbreak of the COVID-19 pandemic. “The Frontiers Report identifies and offers solutions to three environmental issues that merit attention and action from governments and the public at large,” said UNEP Executive Director Inger Andersen. “Urban noise pollution, wildfires and phenological shifts – the three topics of this Frontiers report – are issues that highlight the urgent need to address the triple planetary crisis of climate change, pollution and biodiversity loss.” Urban noise pollution is a growing public health menace Algiers is another city where the noise levels have surpassed acceptable levels. Acceptable noise levels have been surpassed worldwide – in Algiers, Bangkok, Damascus, Dhaka, Ho Chi Minh City, Islamabad, and New York, and more. Additionally, one in five EU citizens are affected by the growing public health menace of noise pollution, which already contributes 12,000 premature deaths and almost 50,000 new cases of ischemic heart disease each year in the European Union. Unwanted, prolonged and high-level sounds from road traffic, railways, or leisure activities impair human health and wellbeing – with issues including chronic annoyance and sleep disturbance. This can result in severe heart diseases and metabolic disorders such as diabetes, hearing impairment, and poorer mental health. Most vulnerable to noise pollution are the very young and the elderly, as well as marginalized communities near high traffic roads and industrial areas, and those far from green spaces. It is also a threat to animals, altering the communication and behavior of various species of birds, insects, and amphibians. The Frontiers report has called for urban planners to reduce noise at the source; invest in alternative mobility; and create urban infrastructure that creates positive soundscapes such as tree belts, green walls, green roofs, and more green spaces overall in cities. Positive examples include London’s Ultra-Low Emission Zone, Berlin’s new cycle lanes on wide roads, and Egypt’s national plan to combat noise. Climate change disrupts natural rhythms in plants and animals The monarch butterfly’s migration is delayed as a result of climate change, impacting its natural rhythm. Climate change has increasingly pushed plants and animals out of sync with their natural rhythms, causing interacting species to work off-balanced with each other, or no longer at the same rate. Plants and animals in terrestrial, aquatic, and marine ecosystems use temperature, day-length, or rainfall as cues for when to unfold leaves or flower, bear fruit, breed, nestle, pollinate, or transform in other ways. Phenology is the timing of these recurring life cycle stages that are driven by environmental forces and interacting species in ecosystems. However, as a result of climate change, these timings are becoming increasingly disrupted, such as when plants shift life cycles faster than the herbivores that consume them. Long-distance migratory species are particularly vulnerable to phenological changes, as climate cues that trigger migration may no longer accurately predict the conditions at their destination and resting sites along the way. For example, the 6-day delayed migration of the Eastern Monarch butterfly has impacted their breeding and access to food, and the resilience of the overall species is weakened as a result, impacting other parts of an interconnected ecosystem. Crops and commercially important marine species may also shift in their natural rhythms, creating additional challenges for food production that already occur as a result of climate change and COVID-19. The report proposes further research be conducted to understand the implications of these phenological mismatches, as well as maintaining suitable habitats and ecological connectivity, strengthening biological diversity, and above all, limiting the rate of global warming by reducing CO2 emissions. Chief UNEP Scientist Andrea Hinwood “All governments and all countries need to consider their environmental impacts and they all certainly need to consider the multiple health activities which impact ecosystems and biodiversity and subsequently health,” said Chief UNEP Scientist Andrea Hinwood during a launch of the report. “All of the actions that will make a difference in terms of protecting the resilience of our ecosystems ultimately protect us because we’re protecting against climate change.” Wildfires projected to get worse Forest wildfires have gotten worse in recent years, with climate change prompting hotter temperatures and drier conditions. Dangerous wildfire weather conditions are projected to become more frequent, more intense, and more severe, including in areas previously affected by fires. This is the result of climate change, including hotter temperatures and drier conditions with more frequent droughts. Intense wildfires can trigger thunderstorms in smoke flumes, generating lightning that ignites other fires beyond the original fire – a hazardous feedback loop. Already an average of about 423 million hectares or 4.23 million square km of the Earth’s land surface – an area about the size of the entire European Union – has burned each year, between 2002 and 2016. In addition, an estimated 67% of annual global area burned by all types of fires, including wildfires, was on the African continent. Long-term effects on human health extend beyond those fighting wildfires, evacuated, or suffering losses. Downwind settlements, sometimes thousands of kilometers from the source, are still vulnerable to health consequences from fires, especially those with pre-existing illnesses, women, children, elderly and the poor. Maarten Kappelle, Head of Thematic Assessments at UNEP The report calls for greater investment in reducing the risks of wildfires; development of prevention and response management approaches to wildfires that address vulnerable, rural, traditional, and indigenous communities; and further refinements in remote sensing, including satellites, radar, and lightning detection. “To manage wildfires more successfully, we must take measures that would prevent them from becoming uncontrollable,” said Maarten Kappelle, Head of Thematic Assessments at UNEP. Image Credits: tph567/Flickr, hyde/Flickr, Paul VanDerWerf/Flickr, UNEP, Project LM/Flickr. EU Health Commissioner Calls for More Preparedness on Eve of EU-AU Summit 17/02/2022 Paul Adepoju & Elaine Ruth Fletcher Charles Michel, President of the European Council European Union President Charles Michel congratulated African countries for their efforts to stimulate more vaccine manufacturing capacity on the continent, in a upbeat opening address at the European Union-African Union Summit, which began Thursday. But in a more sobering note Wednesday, Stella Kyriakides, the European Commissioner for Health and Food Safety, called on global health players to prioritize preparations for the next pandemic. “The pandemic has been a challenge for all of us. For our citizens, for our societies,” Michel said in his opening remarks at the Summit in Brussels. “It opened our eyes and showed us our strengths, our weaknesses, our successes, our failures.” European Union-African Union Summit opens, 17 Feb 2022 Against those challenges, he lauded the recent AU moves on achieving more vaccine self-sufficiency: “We have to look at what you have been doing in the African Union. In less than a year, you launched the manufacture of four vaccines to reduce pharmaceutical dependence on the African continent. And this is a project you devised for Africans, by Africans. Vaccine production capacity has been set up in South Africa, Senegal and Rwanda.” “For us as Europeans, we should be looking at a new way of working, of cooperating with you.” Michel was referring to BioNTech’s announcement Wednesday that it would set up modular “BioNTainer” vaccine production facilities in Rwanda and Senegal by mid-2022. That, in addition to South Africa’s production of the J&J vaccine, and a new WHO-backed mRNA vaccine hub in South Africa, which was the focus of a high-level WHO visit last week. In its gala event in Marburg, Germany on Wednesday, BioNTech executives said they will ship the plug-and-play vaccine facilities to Rwanda and Senegal in 2 modules of six standard freight containers, by mid-2022. The BioNTech announcement has been praised by leading African Union figures, including Africa CDC’s John Nkengasong and special envoy Michel Sidibé. Privilege to participate yesterday in 🇩🇪 alongside my brothers @Macky_Sall,@PaulKagame, @NakufoAddo,@NEPAD_Mayaki in a presentation on the @BioNTech_Group Vaccine Equity for Africa initiative.This world-class techn transfer will manufacture 💉 mRNAs in Africa. @KenupFoundation👏 pic.twitter.com/a1T01fFRDX — Michel Sidibé (@MichelSidibe) February 17, 2022 South Africa’s dilemma But not everyone may be as delighted about the BioNTech initiative. Although South Africa was explicitly mentioned as a third “possible” participant in a BioNTech press release – President Cyril Ramaphosa was noticeably absent from the stage of Wednesday’s launch in Marburg – which featured the heads of state of Senegal, Rwanda and Ghana – alongside WHO and Africa CDC. Entering the Brussel’s summit on Thursday, Ramaphosa told reporters that he remains interested in pushing ahead on discussions about a temporary waiver of intellectual property restrictions on COVID-19 vaccine production. “We are going to discuss the TRIPS waiver,” he shouted back to a press pool – in reference to the hotly-debated waiver that has been sitting before the World Trade Organization TRIPS for over a year now. Arriving #EUAU summit, @devex (me) asks @CyrilRamaphosa whether summit will be success without TRIPS waiver. “We will discuss it” x 2. Is he convinced by European offer on vaccine equity, “no, not yet.” pic.twitter.com/p1Bq31GLxp — Vince Chadwick (@vchadw) February 17, 2022 ‘Not yet’ convinced by Europe’s moves While Ramaphosa acknowledged that Europe had stepped up its vaccine donations, he said that he was “not yet” convinced by the European moves. “We need to move through the TRIPS dispensation where we can make our own vaccines, and that will be very important,” said the South African leader who has placed his vaccine production bets on a new WHO-supported mRNA vaccine technology transfer hub, that would develop open-access brands of mRNA vaccines for not only COVID, but other diseases. That hub is centered around a group of Cape Town research and manufacturing institutions. But some of the hub’s success will depend on how easily it can navigate around existing patent rules on some cutting edge products, like mRNA COVID vaccines. Meanwhile, the TRIPS waiver has been staunchly opposed by leading EU countries, such as Germany, as well as by pharma groups that say bilateral deals between country and the private sector are a more stable basis for sustainable expansion of production capacity. Invest in health systems – prepare for the future Stella Kyriakides, the European Commissioner for Health and Food Safety Speaking Wednesday on the eve of the Summit at the 7th EU-Africa Business Forum 2022, Kyriakides stressed that governments need to invest now in measures that can help prepare for future threats, which are sure to come. “We must not wait and be complacent. But we need to prepare today for future health emergencies,” Kyriakides said. Kyriakides noted that while on its part, the EU has been introducing reforms to strengthen a “European Health Union”, the pandemic has expanded awareness that regional preparedness is no longer sufficient. “In order for us to be truly prepared for emerging health threats, we need to be prepared globally,” she said. In a related move, the European Investment Bank also pledged Thursday to commit some €500 million to a joint WHO-EU initiative strengthening African health systems on the continent. Most countries continue to fall far short of the longstanding Abuja Declaration to allocate 15% of national government spending on health – and the pandemic has created further setbacks. Two Years Into COVID Pandemic, 92 % Of Countries Still Face Significant Health Service Disruptions – Health Policy Watch https://t.co/GPXrhKpLpT via @HealthPolicyW pic.twitter.com/crGfmwzxQM — African Health Observatory Platform (@AHOPlatform) February 17, 2022 Partnering with the African Union Against that context, the EU wants to partner more with the African Union on challenges highlighted by the pandemic, such as the need to reinforce global disease surveillance, and building capacity to undertake emergency countermeasures. She also pledged the EU’s readiness to assist in building up preparedness by supporting the African Medicines Agency (AMA) and the African Preparedness and Response Authority (APRA). She called for the diversification of international supply chains and the resolution of bottlenecks in addition to the expansion of global production of vaccines and therapeutics. “Team Europe”, which includes the EU, EU Member states and European financial institutions, is supporting Africa in this regard with more than €1 billion to create an enabling environment for African vaccine manufacturing, and to tackle barriers related to supply chains and demand, she noted. She also highlighted that the ongoing partnership between the European Centre for Disease Prevention and Control (ECDC) and the Africa CDC is resulting in mutual learning and improved health security for everyone. The COVID-19 pandemic has also strengthened the mandate of the ECDC so it will be able to support epidemic and outbreak responses, and establish a more structured cooperation with public health actors in Africa. Pledging the EU’s contined support for the AMA, she described its creation as a crucial moment in Africa’s journey towards a strengthened regulatory system, which will ultimately contribute to the promotion of sovereignty in Africa. The COVID-19 pandemic has highlighted the need to build healthier, more resilient and more equitable societies, Kyriakides also underlined. But to achieve this, a number of ingredients are essential: “They include the availability of vaccines and therapeutics, but also innovation, data and information sharing. And equally important are the sustainable and locally led development as well as a reformed Global Health architecture. The key ingredient though, are partnerships, trusted and effective collaboration, which needs to be based on the exchange of ideas of experiences and perspectives,” she concluded. Summit – focus on health systems and vaccine production Health is just one of about eight themes of focus at the two-day Summit – along with education, agriculture, climate change, finance and global governance. But in the wake of the destabilization created by the pandemic it clearly has even greater importance to participants now – in comparison with past years. Always pleased to meet my brother @AUC_MoussaFaki, Chair of the @_AfricanUnion. We discussed the importance of scaling up vaccine production in Africa to deliver #VaccinEquity, as well as strengthening @AfricaCDC and African Medicines Agency. @WHO will continue its support. pic.twitter.com/qXVjWruhVb — Tedros Adhanom Ghebreyesus (@DrTedros) February 17, 2022 The EU and AU leaders also are meeting against the backdrop of high regional geopolitical tensions – posed by the continuing threat of a Russian invasion of Ukraine. A Summit press briefing reaffirmed the prior EU commitment to provide 700 million vaccine doses by mid-2022 to developing countries, of which at least 450 million would go to Africa. “Team Europe has exported more than half of its production since the crisis began; it supported the creation of ACT-A [the WHO-supported Act Accelerator] which has delivered more than one billion doses (including 350 million vaccines for Africa). And European countries have shared doses destined for their own citizens, including 125 million to African countries where it is the principal donor.” Emmanuel Macron, President of France Along with Charles Michel, the Summit is being hosted by the President of the European Commission, Ursula von der Leyen and French President Emmanual Macron, whose country currently holds the rotating presidency of the EU Council. In his keynote remarks before the Summit, Macron also reaffirmed the need to support African health systems, wrought by the COVID-19 pandemic. “The COVID-19 pandemic has thrown all of our agenda into the air. It’s been more difficult for African countries to deal with COVID because it is a health, economic and social crisis which has been brought to bare on more fragile economies which are on the verge of development, making it even more costly. African budgets do not have the ability to absorb these shocks as ours do,” said the French president. European Investment Bank Pledges €500 million to WHO-EU Partnership for Stronger African Health Systems 17/02/2022 Editorial team WHO DG Tedros Adhanom Ghebreyesus and EIB President Werner Hoyer. The European Investment Bank said Thursday that it would commit €500 million to improving African health systems, as part of a new initiative with the World Health Organization and the European Union. The joint EIB-WHO-EU statement coincided with the start of an EU-African Union Summit, which is set to talk about how to improve health systems in Africa, as well as stepping up vaccine production. While there have been some recent, big strides to jump-start more African vaccine manufacturing and related R&D, including in the WHO-supported South African mRNA hub and a BioNTech modular vaccine manufacturing initiative, announced only yesterday (hyperlink please to those two stories), much less attention has been focused on health systems, which are the backbone for service delivery. And recent data suggests that African health systems, like others worldwide, continue to suffer setbacks in delivery of other routine services, due to the pandemic. Two Years Into COVID Pandemic, 92 % Of Countries Still Face Significant Health Service Disruptions – Health Policy Watch https://t.co/GPXrhKpLpT via @HealthPolicyW pic.twitter.com/crGfmwzxQM — African Health Observatory Platform (@AHOPlatform) February 17, 2022 That, along with being chronically underfinanced – with most countries far from the Abuja goal of investing 15% of GDP in health services. Only two countries – Rwanda and South Africa – had reached the 15% target in 2011, while seven had actually reduced their health budgets proportionate to their national budgets. The situation had deteriorated further in 2016, with 19 African countries spending less on health as a percentage of their public spending than in the early 2000s. According to the 2016 WHO report, countries with high per capita income such as Algeria, Botswana, South Africa, and Seychelles, do not systematically spend more of their budgets on health, while lower income countries such as Ethiopia, Gambia, and Malawi – have in fact surpassed the 15% goal. The new initiative aims to address both the pandemic-related and more systematic issues, said a WHO press statement on the EIB investment. It noted that the investments would be focused on “restoring, expanding and sustaining access to essential health services and increasing financial risk protection; access to vaccines, medicines, diagnostics, devices and other health products; scaling innovative primary health care service delivery models and investing in a health workforce to deliver effective quality care. “The shared goals of the partnership will achieved by applying a country-led and country-driven approach, identifying gaps in national health systems, designing strategies for interventions and their corresponding investments plans, investing in health system projects and programmes, convening capital providers, supporting implementation and monitoring impact,” said WHO. EIB President Werner Hoyer, said that the goal of the initiative is to mobilize €1 billion of new investment “to strengthen public health across Africa.” Said WHO Director General Dr Tedros Adhanom Ghebreyesus: “The COVID-19 pandemic is a powerful demonstration that when health is at risk, everything is at risk. Investing in health across Africa is therefore essential not just to promote and protect health, but also as a foundation for lifting people out of poverty and driving inclusive economic growth.” Image Credits: EIB/Twitter. BioNTech To Ship Modular mRNA Vaccine Facilities in Containers to African Countries to Jump-start Production 16/02/2022 Elaine Ruth Fletcher Display in Marburg Germany of the BioNtainer container that will be shipped to Africa to jump-start mRNA vaccine manufacturing on the continent. The German-based BioNTech, which co-developed with Pfizer an mRNA COVID vaccine, said on Wednesday that it will set up modular “turnkey” mRNA vaccine facilities to produce the vaccine in Rwanda and Senegal in 2022 – with a fill-and-finish collaboration in Ghana as well. South Africa, which is the new hub for the WHO-supported mRNA vaccine R&D and manufacturing hub focusing on open-access products- may also join the initiative later, said the company in a press release. Speaking at a press briefing Wednesday morning, which included the presidents of Rwanda, Ghana and Senegal, as well as WHO and Africa CDC, BioNTech CEO Ugur Sahin, described the new cutting-edge BioNTainer initiative for vaccine production as – following “the most elementary principle of reducing complexity by copying the manufacturing units having modular action unit and by copying the process and transferring it to another place. “But this is not about innovation alone, it it is about collaboration,” Sahin added, “for example, implementation of the manufacturing side, about regulation, about supply of vaccines… no one can do it alone, we have to do it together,” Sahin said. He said that the first containers would be delivered to Africa in mid-2022 “and we want to start with the manufacturing of the first vaccine batches in the first months after we deliver the containers.” The new production facilities are designed to produce not only COVID-19 vaccines, but other “future vaccines” in the planning for malaria, tuberculosis and HIV: “If these vaccines are successful and approved they will be produced in Africa, and these containers can be useful.” Welcomed by African leaders Left to right: BioNTech CMO Özlem Türeci and CEO Ugur Sahin; with African heads of state, Nana Akufo-Addo (Ghana); Macky Sall (Senegal) and Paul Kagame (Rwanda) and WHO’s Director General Tedros Adhanom Ghebreyesus; and kNUP’s Holm Keller at BioNtech briefing on new BioNTainer plug-and-play facility. The initiative was roundly welcomed by the heads of Ghana, Senegal, Rwanda – all of whom were present at the briefing – as well as the heads of WHO and Africa CDC. “Today is a historic day. Today, we are putting an end to the vaccine injustice that has occurred during the pandemic, where Africa was left by the wayside,” said Senegal’s President Macky Sall, who opened Wednesday’s public briefing in Marburg, Germany, where the three African heads of state had been meeting with BioNTech officials over the past several days on the BioNtainer concept. “Thanks to the innovation of BioNtech, with the BioNtainer, we are going to transfer the technology to Africa, to produce the API for the mRNA vaccines, along with the fill-and-finish. And we can thus be able to produce COVID-19 vaccines, as well as having the potential to produce vaccines for other diseases,” he said. “We commend this cooperation between Europe and Africa, between BioNTech and African countries, as well as foundations and development banks that are providing the financial backing, so that we can very soon produce these vaccines on our continent.” Africa CDC head John Nkengasong also welcomes the new BioNTech initiative Meanwhile, Africa CDC head John Nkengasong praised BioNTech for “showing leadership” on the innovative ‘turn key’ production facilities, saying, “You are teaching us how to fish, and not giving us a fish….The African Union and Africa CDC will continue to work with you in this journey.” And Ghana’s President Nana Akufo-Addo, said his country would be dedicating it’s National Vaccine Institute to support the initiative to develop “partnerships for vaccine deployment and manufacturing in areas of funding, clinical trials and fill-and-finish capacity.” Ghana will set up a fill-and-finish facility soon, he said, in order to perform the last step of the BioNTech process – to be completed outside of the modular vaccine factory containers. BioNTainer concept explained at BioNTech press briefing on Wednesday 16 February 2022 WHO affirms initiative has African “ownership” Meanwhile, WHO’s Director General Dr Tedros Adhanom Ghebreyesus expressed support for the new project – despite the criticism that had been levelled at it in a recent BMJ investigation, which had portrayed it as a potential competition to the new WHO-supported mRNA vaccine manufacturing hub set up in South Africa, which aims to promote an open-license approach to vaccine manufacturing – in contrast to collaborations built around the bilateral licensing of patented products, such as Pfizer’s. Tedros visited the South African mRNA hub, which has replicated a version of the Moderna mRNA vaccine, just last Friday. “Many colleagues have been discouraged about the success of this project,” said Tedros, in an oblique reference to the earlier criticism levelled at the notion of shipping ready-made vaccine facilities in containers to Africa. He underlined that the endorsement by African national and African Union leaders shows that the BioNTech initiative is viable: “Their presence shows political commitment, their presence shows ownership. And when projects are owned and political commitment is provided from the leaders, projects normally succeed…. failure is not an option for this project, from what I observed,” said Tedros. .@DrTedros @WHO in oblique reference to prior @BMJ criticism of the initiative says "many colleagues have been discouraged about the success of this project….one thing that convinces me is that the presence of these leaders – their presence shows ownership." https://t.co/0GvaqaRSJ9 pic.twitter.com/lZFEBRQmiD — Health Policy Watch – Global Health News Reporting (@HealthPolicyW) February 16, 2022 ‘Miniaturized’ and standardized mRNA production BioNTech COO Sierk Poetting at a meeting briefing on the BioNTainer initiative. The new manufacturing systems effectively takes advantage of the comparatively small size of mRNA vaccines inputs, and their unique production technology, to “miniaturize” and standardise the vaccine production process, said BioNTech’s BioNTech Chief Operating Office (COO) Sierk Poetting at a press conference later Wednesday afternoon. He said innovation had been developed at Pfizer’s Marburg, Germany facility, which is Pfizer’s largest manufacturing operation, and would also now serve as global quality control center for the plug-and-play systems sent to Africa. The modular facilities would be built of ISO-standard 40 foot containers “We can put them on trucks, boats, or planes and ship those manufacturing BioNtainers to the world, to the target locations,” said Poetting. “The power of the mRNA drug class is that it is versatile and can be prepared rapidly,” said Sahin, noting that the facilities would also serve the production of future mRNA vaccines under development by Pfizer for other diseases. Turnkey facilities will be pre-approved as GMP complaint in Germany Turnkey facilities will be pre-approved as GMP compliant in Germany and then shipped to Africa – BioNTech CEO Sahin Sahin said that the modular facilities could be pre-approved as GMP compliant at Pfizer’s Marburg, Germany plant where the turnkey solution was developed – and which will supervise the initiative: “The turnkey package includes the modular production unit, GMP compliance set up, and personnel training to ensure that we can transfer the technology,” he explained. “The elements of the container-based, plug-and-play approach was modular design.. by having this standardized design, we can ensure that the facility, once approved somewhere, can be transferred to another place, and with a little additional work, the process can be GMP [compliant]. That means that the facility would be built and pre-approved to meet European manufacturing requirements, and once transferred to Africa, could be quickly approved by national regulatory processes as well, ensuring a quick start to manufacturing, said Sahin. Turnkey facility includes “plug and play” production meeting GMP standards, said BioNTech’s Ugur Sahin, at the press conference. There would be six containers – six for producing the active pharmaceutical ingredient and six more for producing the final drug product. They would be set up in an air-conditioned factory hall, equipped with refrigeration and other basic infrastructure, Poetting explained. ‘Fill and finish’ would take place at other sites in collaboration with national and local African partners. Sahin said that the first facility would be set up in mid-2022, with the aim of being fully operational by the end of the year. The facilities could produce up to 50 million doses a year – although actual production would vary by demand. Products would be sold at cost in African Union countries. “The goal of the BioNtainer is to reduce the cost and the speed of the development of manufacturing facilities, and provide a solution which is suitable for the needs of people living in this region,” said Sahin. Did BioNTech’s kENUP consultants try to undermine South Africa’s mRNA vaccine hub? Tedros visits Stellenbosch University’s Biomedical Research Institute & Centre for Epidemic Response & Innovation on 11 February, 2022, part of South Africa’s WHO co-sponsored mRNA vaccine hub. Asked why BioNTech had decided not to share Pfizer’s vaccine technology with the new WHO-supported mRNA vaccine tech transfer hub in South Africa, Poetting said that the company would collaborate by taking staff that are trained there to help manage the new BioNTech manufacturing facilities – which would initially be staffed by Pfizer’s European teams. “We will onboard the local teams and do the knowledge transfer and the production together,” Poetting said, adding, “we are actually collaborating with the transfer hubs. We will work together with the transfer hubs on staffing the units, on training the units, and for distribution of the units” he said. But for actual production processes, the BioNTainer facilities could be set up and become operational sooner, he asserted. Meanwhile, Sahin refused to comment on the recent allegations, published in The BMJ that the kENUP Foundation, a BioNTech consultancy that helped develop the BioNTainer initiative, had actually sought to undermine the South African tech transfer hub – which along with training African scientists and technicians also aims to develop open-access versions of mRNA vaccines. Holm Keller of the kENUP Foundation, moderating BioNTech’s launch of its new “BioNTainer’ initiative on Wednesday; kENUP is also alleged to have sought the “termination” of the WHO-supported South African mRNA hub. According to The BMJ, kENUP had sent a mission report to the South African government after a visit last August, saying that the hub’s project “of copying the manufacturing process of Moderna’s COVID-19 vaccine should be terminated immediately. This is to prevent damage to Afrigen, BioVac, and Moderna . . . “Provided that the release from patent cover will be granted by Moderna only during the pandemic, the sustainability outlook for this project of the WHO Vaccine Technology Transfer Hub is not favourable,” stated the report, obtained by The BMJ. Scientists at Afrigen have since said that they managed to replicate the Moderna mRNA vaccine – without assistance from the US-based pharma firm, which has nonetheless promised not to enforce its patents on its COVID-19 vaccine during the pandemic. “We can’t comment on behalf of kENUP, and also not on behalf of WHO,” Sahin said. “We can just state that at the moment several projects with the same goal are underway, and we welcome any projects with the same goals. What is important at the beginning, of course, to understand the overall framework, and what are the specific aspects of the individual partners, and identify ways to collaborate.” New projects on African continent – a turning point… In fact, the silver lining in the vaccine inequalities in Africa, sharply highlighted by the COVID pandemic, is the surge of new vaccine manufacturing initiatives, said Greg Perry, Assistant Director of the International Federation of Pharmaceutical Manufacturers and Associations, in a comment to Health Policy Watch. “What is significant is how much is happening on the African continent, and much from private sector, from J&J ‘s agreement with Aspen Pharmacare, to the BioNTech- Biovac partnership on manufacturing and distribution activities, to the various BioNTech actions announced today,” he said. He made his comment shortly after the new head of Tanzania, formerly one of the continent’s most COVID vaccine-hestitant countries, said that it, too, would like to set up a vaccine manufacturing plant to tackle COVD and other diseases. New President, Samia Suluhu Hassan described her plans at a meeting with European Union President Charles Michel in Brussels, BBC reported. Meanwhile, in Nigeria, a vigorous debate over the creation of a national vaccine manufacturing initiative is also underway. “We should be open to all these initiatives,” Perry said. “But what is key is that are long term, sustainable, and based on voluntary partnership. Moreover they will all face the same challenges, needs for skills and regulatory support; long- term financing and demand stability. It’s these real challenges and solutions we are talking about in Brussels this week at the European-African Business Forum,” he said, referring to a pharma meeting ongoing this week ahead of European Union-African Union summit. Ont the other side of the fence, pharma critics that have looked at the South African mRNA hub, as the seedling from which new patent-free modes of vaccines manufacture might take root and flourish on the continent, were not so enthusiastic about the new BioNTech initiative. “When local production in Africa is done under monopoly control of Pfizer/BioNtec, how does that increase technological autonomy and resilience?” asked Els Torreele, a visiting fellow at the Institute for Innovation and Public Purpose at University College London, in a tweet. https://twitter.com/ElsTorreele/status/1493974017967067142 Image Credits: BioNTech, BioNTech , @StellenboschUni, BioNTech Press conference . Depression Remains Overlooked and Underfunded; Experts Call to Reduce Global Burden 16/02/2022 Raisa Santos Street scene in Metro Manila, Intramurous district, Philippines. 80-90% of those with depression are left untreated or undiagnosed in low- and middle-income countries. Homelessness is one adverse experience that may cause depression. With about half of people suffering from depression in high income countries untreated or undiagnosed, with this number rising to 80-90% in low- and middle-income countries, a Lancet and World Psychiatric Association Commission have called for a unified response against this global crisis to reduce the burden of depression. Depression is estimated to impact 5% of adults globally, with its onset most frequent in young people. COVID-19 has caused ‘mass trauma’ worldwide and has further worsened mental health for millions, creating additional challenges with isolation, bereavement, uncertainty, hardship, and limited access to healthcare. To combat the crisis, the Commission’s ‘Time for united action on depression’ calls for a concerted and collaborative front from all – government, healthcare providers, researchers, and people living with depression, to improve care and prevention, fill knowledge gaps, and increase awareness for one of the leading causes of avoidable suffering and premature death worldwide. “Depression is a global health crisis that demands responses at multiple levels,” said Commision Chair Professor Helen Herrman. “This Commission offers an important opportunity for united action to transform approaches to mental health care and prevention globally.” The report is authored by 25 experts across 11 countries, from experts in neuroscience to global health. It is advised by people with experience of depression. Myths surrounding depression fuel inaction Myths surrounding mental health have fueled inaction. While 70-80% of people who die by suicide in high income countries, and around half in LMIC, suffered from mental illness, with depression as the most common cause, myths surrounding this health condition have fueled global inaction towards depression. The myths include the misconception that depression is simply sadness, a sign of weakness, or restricted to certain cultural groups. Depression also has an under-recognized social and economic toll, with the loss in economic productivity linked to depression costing the global economy an estimated $1 trillion a year. “There is arguably no other health condition which is as common, as burdensome, as universal, or as treatable as depression, yet it receives little policy attention and resources”, said Commission Co-Chair Associate Professor Christian Kieling, of the Brazil-based Universidade Federal do Rio Grande do Sul. The Commission does stress that depression is distinctly a health condition that is characterized by persistence, as it inhibits daily functioning and may lead to long-term health consequences. Depression may also impact anyone, regardless of gender, background, social class, and age, though symptoms and signs of depression may vary among groups. Society and individual strategies proposed Mental health services for children and adolescents have been disrupted due to COVID-19. Solutions to reduce the global burden of depression need to prevent adverse experiences in childhood. Whole-of-society and individual level strategies have been proposed by the Commission to prevent depression, focusing on reduced exposure to adverse experiences in childhood, lifestyle factors, and other stressful events, including financial crisis or bereavement. “Prevention is the most neglected aspect of depression. This in part because most interventions are outside of the health sector”, said co-author Dr Lakshmi Vijayakumar from SNEHA, Suicide Prevention Centre and Voluntary Health Services of Chennai, India. Vijayakumar further noted how crucial these prevention efforts are. “In the face of the lifelong effects of adolescent depression, from difficulty in school and future relationships to risk of substance abuse, self-harm, and suicide, investing in depression prevention is excellent value for money. It is crucial that we put into practice evidence-based interventions that support parenting, reduce violence in the family, and bullying at school, as well promoting mental health at work and addressing loneliness in older adults.” Current classification of depression is ‘too simplistic’ The current classification that places people with symptoms of depression into just two categories – either they have clinical depression or not – remains too simplistic, says the Commission. Instead, the Commission supports a personalized, staged approach to depression care that tailors and recommends interventions to the individual and the severity of their condition. These treatments range from self-help to lifestyle changes to psychological therapies. “No two individuals share the exact life story and constitution, which ultimately leads to a unique experience of depression and different needs for help, support, and treatment”, explained Commission Co-Chair Professor Vikram Patel from US-based Harvard Medical School. In addition, the Commission also proposes collaborative care strategies that incorporate locally recruited, widely available non-specialists such as community health workers and lay counselors. Ultimately, they conclude that greater investment is needed on behalf of the government to reduce the damaging impact of poverty, gender inequity, and other social inequalities on mental health. Said Patel: “Tackling the climate emergency, the COVID-19 pandemic and other global and regional emergencies that exacerbate existing inequities and threats to health, including pursuit of the UN Sustainable Development Goals, must also be vital parts of efforts to prevent depression.” Image Credits: Wayne S. Grazio, Nenad Stojkovic/Flickr, WHO/NOOR/Sebastian Liste. US and Africa Plan to Harness PEPFAR Networks to Increase COVID Vaccine Uptake 15/02/2022 Kerry Cullinan US Secretary of State Antony Blinken CAPE TOWN – The US and Africa intend to use the well-established community networks supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) to improve the uptake of COVID-19 vaccines in Africa. The initaitive would build upon the infrastructure developed since PEPFAR entered as a major player on the African AIDS scene in 2003. In addition, USAID has launched an initiative called Global VAX to support the World Health Organization (WHO) target of vaccinating 70% of the world’s population by mid-year against COVID-19, and will soon be announcing priority countries in Africa. This is according to US State official Mary Beth Goodman, who briefed African journalists on Tuesday on the COVID-19 Global Action Meeting convened by US Secretary of State Antony Blinken on Monday. “We’re leveraging opportunities through things like PEPFAR, which has an extraordinary network across the African continent in combating HIV/AIDS and has a network of community workers and leaders who are helping to work with us to also talk about some of the importance of COVID,” said Goodman, who is Acting Coordinator for Global COVID-19 Response and Health Security at the US Department of State. “The same is true of our Presidential Malaria Initiative and other efforts that have long been in place on the continent. “We actually have launched through USAID and the Centre for Disease Control, a programme that we’re calling Global VAX,” added Goodman. “The effort behind Global Vax is all about the uptake issues. How do we turn vaccines into vaccinations? How do we connect the dots to make sure that we are getting these vaccines distributed in a way that allows more people to have the opportunity to take the vaccine and that allows some of these countries which are lagging to meet the 70% target?” Blinken’s six-point ‘GAP’ plan Ghanian health worker Evelyn Narkie Dowuona holds up her COVID-19 vaccination card. Blinken presented a six-point COVID-19 Prioritized Global Action Plan for Enhanced Engagement (GAP) to foreign ministers and senior leaders from countries and international organizations invited to his virtual meeting. “Together, we identified urgent gaps in response activities and aligned around specific roles to advance global efforts aimed at bringing this pandemic under control and strengthening readiness for future global health threats. We agreed that more political leadership is needed to save lives and end this pandemic cycle in 2022,” said Blinken in a statement issued late Monday. He identified the “six lines of the global effort to respond to acute pandemic needs” as: Getting Shots in Arms: coordinated efforts to improve vaccine readiness and logistics, in step with increased donations and procurement, toward the goal of at least 70% of the population fully vaccinated with quality, safe, and effective vaccines by September 2022. Bolstering Supply Chain Resilience: mechanisms to facilitate sufficient and steady supplies of critical products and materials to break this cycle of the COVID-19 pandemic, including establishing mechanisms to identify and remove medical supply chain bottlenecks. Addressing Information Gaps: global efforts to enhance vaccine confidence and combat the spread of false information, enlisting regional champions and medical, civil society, young people, and faith leaders to use evidence-based, accurate, locally relevant messaging. Supporting Health Workers: protecting the health, safety, and wellbeing of frontline health workers, including the need to improve their training and numbers to effectively support the COVID-19 response. Ensuring Acute Non-Vaccine Interventions, including the provision of therapeutics, testing regimes, and oxygen where needed most. Strengthening Global Health Security Architecture to end the current pandemic and. secure future preparedness for health emergencies at the national, regional and global level. Blinken also announced a direct donation of 5 million doses of Johnson & Johnson’s COVID-19 vaccine to the African Vaccine Acquisition Trust (AVAT), the African Union’s vaccine procurement and distribution effort. The US has now donated more than 155 million doses to Africa and 435 million doses worldwide. Praise for Uganda vaccine effort Ugandan Health Minister Dr Jane Ruth Aceng (left) and French Ambassador to Uganda Jules-Armand Aniambossou with donated AstraZeneca COVID-19 vaccines. In his address to the GAP meeting, Blinken praised Uganda for its massive vaccination effort in November and December last year as an example of what is possible. “In early November, only 14% of all Ugandan adults had received their first dose of the vaccine,” said Blinken. “Then a major team effort commenced. The Ugandan government led a mass vaccination campaign, carried out by hundreds of health care workers,” he added, and “by late December, almost half of all adults in Uganda had received their first shot – from 14 to 47% in just six weeks”. Participants in the GAP meeting included Australia, Canada, Colombia, France, Germany, India, Indonesia, Italy, Japan, the Republic of Korea, New Zealand, Saudi Arabia, Senegal, South Africa,Spain, UK, the African Union/Africa Centres for Disease Control, the European Commission, and the WHO. They have all committed to coordinating parts of the six key areas identified. Meanwhile, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the meeting that “in some countries, high vaccine coverage, combined with the lower severity of Omicron, is driving a false narrative that the pandemic is over”. However, the low vaccine coverage and low testing rates in other countries “are creating the ideal conditions for new variants to emerge”, warned Tedros, adding that 116 countries are off track to vaccinate 70% of the population by the middle of this year. “We can bring the pandemic under control this year – but we are at increased risk of squandering that opportunity,” said Tedros, adding that “in many countries, the issues are not primarily a problem of absorptive capacity. We need to urgently support political leaders to accelerate the rollout of vaccines”. Image Credits: WHO, Health Journalist Network. Malnourished Afghan Children in The Grasp of Measles Outbreak 15/02/2022 Shadi Khan A mother and her child in the Haji camp for internally displaced people in Kandahar, Afghanistan. More and more children are losing their lives to a measles outbreak in Afghanistan as the country struggles with a humanitarian crisis under the US sanctions on the country’s Taliban regime. Following the Taliban’s takeover of Afghanistan, the US Department of the Treasury froze Afghanistan Central Bank’s reserves, mostly held in US banks, as the Taliban has been on its “specially designated global terrorist group” since 2002, and any support for the group is illegal. The measles outbreak has hit the malnourished children hard in some of the already marginalized and poor communities in Paktika, Ghor, Badakhshan and other provinces of Afghanistan. The World Health Organization (WHO) last week confirmed that the number of cases and deaths increased by 18% in the week of 24 January, and 40% in the week of 31 January. Health Policy Watch reported last week that WHO Director-General Dr Tedros Adhanom Ghebreyesus met with the Taliban in Geneva to discuss Afghanistan’s health challenges. Struggle for meals in the pandemic According to the global health body, as many as 35,319 suspected cases of measles and 156 deaths have been reported in Afghanistan between 1 January 2021 and 29 January 2022. Of these, 3,221 cases were laboratory confirmed while 91% of these cases and 97% of these deaths were in children under five years of age. The WHO says that the rise in measles cases is especially concerning because of the extremely high levels of malnutrition in Afghanistan. This weakens immunity, making people more vulnerable to illness and death from diseases like measles – especially children. Local civil society activist in Paktika, Abdul Bari, mentioned that with the fall of the previous government, thousands of people lost their jobs and could not support families for months now that ultimately led to malnourishment and spread of the diseases. “Many families who were doing relatively well in the past now find them among the so many very poor in the society that struggle to feed one or two meals in Paktika”, he said. Mirwais Hospital, Kandahar – The hunger and poverty is more visible than ever in Afghanistan especially on the faces of the youngest victims of the crisis. Hospitals and healthcare facilities are filling up with babies and children suffering from malnutrition pic.twitter.com/J8B6VyEocS — Yalda Hakim (@SkyYaldaHakim) November 29, 2021 Authorities in Badakhshan province told the Health Policy Watch about an outbreak of measles worst affecting the remote Kuf Ab and Kohistan districts of the province where poverty is widespread. “The measles outbreak has been spreading in the province for the past two months and has spread to ten districts, including the capital Faiz Abad”, he said, adding that so far no organization or health institution has come to their aid and many children have died due to the disease in Kuf Ab and Kohistan districts. Equally remote and poor, Ghor province in the central highlands of Afghanistan is the second flashpoint for the measles outbreak according to the Afghan authorities. The provincial health department head, Mohammad Nazim, told the Health Policy Watch that more than a thousand children have been referred to the province’s central hospital recently and 21 of whom have died because of measles. “The reason for the spread of measles is the non-implementation of the vaccination program firstly due to the coronavirus pandemic and then the security concerns and lack of funds”, he said. Crumbling Healthcare System In December 2021, a measles outbreak response immunisation campaign was carried out with the support of the WHO in some of the most affected provinces, reaching 1.5 million children. Battling for survival, Afghanistan’s fragile health system has been on the edge for months in the wake of the COVID-19 pandemic, the Taliban takeover of power and the subsequent US freezing of Afghanistan’s state reserves. In Ghor, the regional public hospital sources said the doctors and support staff is so overstretched and under-paid that it can collapse any moment in the wake of mounting cases of COVID-19 and now the measles outbreak. Kabul-based paediatrician Dr Zar Wali told the Health Policy Watch that malnutrition among children was severely compromising their immune system. “On a daily basis I am receiving dozens of child patients from the city (Kabul) as well as the nearby provinces, and there is this clear pattern of malnourishment in almost all, which makes them susceptible to all sorts of diseases”. This was echoed by the UN Children Fund (UNICEF) last week when it warned that as the humanitarian crisis deepens in Afghanistan, hospitals were receiving so many cases each day of children suffering complications associated with severe acute malnutrition. After relatively low transmission in 2019 and 2020, new infection cases have been increasing in all provinces since the end of July 2021, with the highest weekly toll observed so far occurring over the last four weeks. The WHO has warned that although the number of deaths is relatively low, the rapid rise in cases in January 2022 suggests that the number of deaths due to measles is likely to increase sharply in the coming weeks. Being endemic in Afghanistan, more than 25,000 children get killed by the measles virus annually, according to the Ministry of Public Health, and many more struggle with its impacts. The WHO has expressed willingness to prepare a plan for a larger measles outbreak response immunisation campaign, which will start in May (or earlier, if possible), aiming to reach more than 3 million children in Afghanistan. Image Credits: © UNICEF Afghanistan. African Medicines Agency Host Country Could be Selected by July 15/02/2022 Kerry Cullinan Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD The African Union could decide on the host country for the African Medicines Agency (AMA) as early as July, while the agency’s director-general should be appointed by the end of the year. This is according to Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD, the African Union’s development agency. The AU Assembly had recently decided to “do an assessment of the countries that have offered to host the AMA headquarters”, she told a workshop convened by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on Monday ahead of the EU-AU Summit which starts in Brussels on Thursday. “The AU Commission and AUDA-NEPAD are working together, and the teams are set to go out in the first week of March,” said Ndomondo-Sigonda, adding that the country visits may take two months to complete. “Once they are done, then the assessment report will be presented before the first meeting of the Conference of the State Parties that is planned to be held sometime in May,” she added. Whatever decision is made by this body would have to go to the AU Assembly during its meeting in in June or July, “so by July we will know which countries actually hosting the headquarters for the African Medicines Agency,” she added. The Assembly comprises of all Member State Heads of State and Government is the AU’s supreme policy and decision-making organ. Director-General may be appointed by year-end As far as the appointment of the head of the AMA – its director general – is concerned, this would take a little longer. First, the Conference of the State Parties would have to consider the terms of reference for the position at its May meeting, and advertisements will only go out after that. “By the time we get to know who has been appointed as the director-general, it will probably be quarter three or quarter four this year,” she said. She added that AMA was being established as “a specialised agency of the African Union with its autonomy in terms of financial and human resources, so it’s going to be operating differently from what you see with Africa Centres for Disease Control at the moment”. Meanwhile, UNAIDS Executive Director Winnie Byanyima welcomed the imminent establishment of the AMA. “Since the very beginning of the COVID crisis, the multilateral response may have failed us but African leadership has been remarkable,” said Byanyima at a workshop on Monday. “The newly created African Medicines Agency will harmonise medicine regulations, and negotiate joint purchasing and the manufacture of our own medicines.” European and African Pharma Sector Want Permanent Platform to Support African Development 14/02/2022 Kerry Cullinan A staff member at Afrigen, the mRNA hub in South Africa, prepares part of the vaccine. The major players in the European and African pharmaceutical sectors have called on the European Union (EU) and the African Union (AU) to support the creation of a permanent “business platform” to foster the pharma industry’s development in Africa. This emerged at a workshop Monday hosted by the the European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) along with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and other European-based pharma associations. The workshop was part of the European African Business Forum (EABF) taking place ahead of, and along with, the European Union–African Union Summit, which begins Thursday in Brussels. The business platform should support the development of EU and AU policies conducive to trade and “sustainable financing mechanisms models with access to low-interest capital” and appropriate incentives to encourage local, regional and international private sector investment, according to IFPMA Assistant Director-General Greg Perry, speaking at the Monday EABF session leading up to the Summit. Businesses also want a “stable business environment that respects business ethics and incentivises local innovation and entrepreneurship, including through intellectual property, ensure development and retention of local skilled workforces”, said Perry, reading from a joint statement by the EABF’s Healthcare Working Group, which also includes the European Federation of Pharmaceutical Manufacturers and Associations (EPFIA) and Vaccines Europe. The pharmaceutical sector also wants voluntary and mutually agreed upon technology transfers and joint ventures; timely product registration, harmonisation of regulation particularly through the African Medicines Agency, and the implementation of the African Continental Free Trade Area to eliminate non-trade barriers and foster international supply chain security. “We believe that creating this platform with the support of the EU and the AU, we could facilitate African and European partnerships, support existing continental and regulatory initiatives and create a win-win for both Africa and Europe,” said Perry. Where is the money that was promised? Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee Emmanuel Mujuru, representing the Federation of African Pharmaceutical Manufacturers (FAPMA), said that the African pharmaceutical industry was struggling to access affordable financing. “This financing has to both long-term in nature and have affordable interest rates, either in the form of loans or equity participation in already established African pharma management companies,” said Mujuru. He added that there was a significant opportunity for European investors as between 70 and 90% of essential medicines consumed in Africa were imported and that the pharmaceutical sector was growing at over 10% per annum, second only to Asia. Merck’s Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee, said that while setting up fill and finish operations “is easy to implement in two years”, he had tried to do so in three different African countries but “local private sector investors have never been able to get access to any finance”. “Why? The International Finance Corporation has announced $4 billion for the local vaccine manufacturing and the European Commission has announced one billion Euros,” asked Bendhaou “We also have to invest in the health system capacity because otherwise, you can have a nice factory in in South Africa, a beautiful factory in Egypt, producing hundreds of millions of doses but if you don’t have a health system in place for the uptake and to absorb this capacity,” he added. What about Gavi subsidies? Biovac CEO Patrick Tippoo Meanwhile, Patrick Tippoo, CEO of the South African company, Biovac and part of the African Vaccine Manufacturing Initiative (AVMI) leadership, said that much of Africa’s vaccine supply “comes in a subsidised form, partially or completely by Gavi through UNICEF”. “We know that Gavi drives prices down to make vaccines more affordable so more vaccines can be purchased and therefore distributed,” said Tippoo “We have a current situation where about 40 of the 54 countries depend on this mechanism. And therefore the market in Africa is actually in Copenhagen, as some people say. “This is a structural thing that will have to be addressed because, in order to stimulate and incentivize technology transfers, investment in skills, development, regulatory capacity building – and all the things that we repeat ad nauseum – there needs to be an assurance that there’s going to be a market when all of this is built,” he stressed. Tippoo added that African governments and other stakeholders had to understand that a “resilience premium” would need to be paid to ensure that pharmaceutical manufacturing capability is built in Africa. “There is no way in which vaccines coming out of Africa in the next five or 10 years can compete on a cost of goods perspective, with Indian manufacturer factories, or even multinationals because they’ve monetised the investment over time, and they have economies of scale,” he added. Diversification a ‘win-win’ for Africa, Europe and globally However, other participants pointed out that over the long-term, diversification of sources for pharma procurement is going to be a win win, given the comparatively limited number of suppliers, for some key global health products. Interruptions to key medical supply chains were particularly evident during the early stages of the COVID pandemic, exposing their fragility, even for more affluent countries. Sibilia Quilici, Executive Director, Vaccines Europe, pointed out that from the European perspective, too, it would be beneficial to reduce dependence on what is now a comparatively small number of suppliers, mainly from India and China, and integrate Africa’s supply chains with global ones: “In the context of this discussion on improving manufacturing capacities in Africa, also for APIs [active pharmaceutical ingredients] it is good to be aware that the EU, the largest API importer in the world is looking for supply chain diversification for products where dependence on a small number of suppliers from India and China is a concern. “This could be a win-win for Africa, EU, local and global industry”. Image Credits: Rodger Bosch for MPP/WHO, WHO . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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Noise, Wildfires, and Disruptive Timings of Life Cycles are Looming Environmental Threats, Warns UNEP Report 18/02/2022 Raisa Santos Ho Chi Minh City street traffic. The city is one of many that have surpassed acceptable noise levels. Urban noise pollution, wildfires, and disruptions of life cycles in natural systems are all growing environmental problems with ecological consequences that require greater attention, according to the new Frontier Report published Thursday by the UN Environment Programme (UNEP). The fourth edition of the report, ‘Noises, Blazes and Mismatches: Emerging Issues of Environmental Concern’, was released days before the resumed fifth session of the UN Environment Assembly (UNEA), to start on 28 February – 2 March. The report was first published in 2016 with an alert to the growing risk of zoonotic diseases, four years before the outbreak of the COVID-19 pandemic. “The Frontiers Report identifies and offers solutions to three environmental issues that merit attention and action from governments and the public at large,” said UNEP Executive Director Inger Andersen. “Urban noise pollution, wildfires and phenological shifts – the three topics of this Frontiers report – are issues that highlight the urgent need to address the triple planetary crisis of climate change, pollution and biodiversity loss.” Urban noise pollution is a growing public health menace Algiers is another city where the noise levels have surpassed acceptable levels. Acceptable noise levels have been surpassed worldwide – in Algiers, Bangkok, Damascus, Dhaka, Ho Chi Minh City, Islamabad, and New York, and more. Additionally, one in five EU citizens are affected by the growing public health menace of noise pollution, which already contributes 12,000 premature deaths and almost 50,000 new cases of ischemic heart disease each year in the European Union. Unwanted, prolonged and high-level sounds from road traffic, railways, or leisure activities impair human health and wellbeing – with issues including chronic annoyance and sleep disturbance. This can result in severe heart diseases and metabolic disorders such as diabetes, hearing impairment, and poorer mental health. Most vulnerable to noise pollution are the very young and the elderly, as well as marginalized communities near high traffic roads and industrial areas, and those far from green spaces. It is also a threat to animals, altering the communication and behavior of various species of birds, insects, and amphibians. The Frontiers report has called for urban planners to reduce noise at the source; invest in alternative mobility; and create urban infrastructure that creates positive soundscapes such as tree belts, green walls, green roofs, and more green spaces overall in cities. Positive examples include London’s Ultra-Low Emission Zone, Berlin’s new cycle lanes on wide roads, and Egypt’s national plan to combat noise. Climate change disrupts natural rhythms in plants and animals The monarch butterfly’s migration is delayed as a result of climate change, impacting its natural rhythm. Climate change has increasingly pushed plants and animals out of sync with their natural rhythms, causing interacting species to work off-balanced with each other, or no longer at the same rate. Plants and animals in terrestrial, aquatic, and marine ecosystems use temperature, day-length, or rainfall as cues for when to unfold leaves or flower, bear fruit, breed, nestle, pollinate, or transform in other ways. Phenology is the timing of these recurring life cycle stages that are driven by environmental forces and interacting species in ecosystems. However, as a result of climate change, these timings are becoming increasingly disrupted, such as when plants shift life cycles faster than the herbivores that consume them. Long-distance migratory species are particularly vulnerable to phenological changes, as climate cues that trigger migration may no longer accurately predict the conditions at their destination and resting sites along the way. For example, the 6-day delayed migration of the Eastern Monarch butterfly has impacted their breeding and access to food, and the resilience of the overall species is weakened as a result, impacting other parts of an interconnected ecosystem. Crops and commercially important marine species may also shift in their natural rhythms, creating additional challenges for food production that already occur as a result of climate change and COVID-19. The report proposes further research be conducted to understand the implications of these phenological mismatches, as well as maintaining suitable habitats and ecological connectivity, strengthening biological diversity, and above all, limiting the rate of global warming by reducing CO2 emissions. Chief UNEP Scientist Andrea Hinwood “All governments and all countries need to consider their environmental impacts and they all certainly need to consider the multiple health activities which impact ecosystems and biodiversity and subsequently health,” said Chief UNEP Scientist Andrea Hinwood during a launch of the report. “All of the actions that will make a difference in terms of protecting the resilience of our ecosystems ultimately protect us because we’re protecting against climate change.” Wildfires projected to get worse Forest wildfires have gotten worse in recent years, with climate change prompting hotter temperatures and drier conditions. Dangerous wildfire weather conditions are projected to become more frequent, more intense, and more severe, including in areas previously affected by fires. This is the result of climate change, including hotter temperatures and drier conditions with more frequent droughts. Intense wildfires can trigger thunderstorms in smoke flumes, generating lightning that ignites other fires beyond the original fire – a hazardous feedback loop. Already an average of about 423 million hectares or 4.23 million square km of the Earth’s land surface – an area about the size of the entire European Union – has burned each year, between 2002 and 2016. In addition, an estimated 67% of annual global area burned by all types of fires, including wildfires, was on the African continent. Long-term effects on human health extend beyond those fighting wildfires, evacuated, or suffering losses. Downwind settlements, sometimes thousands of kilometers from the source, are still vulnerable to health consequences from fires, especially those with pre-existing illnesses, women, children, elderly and the poor. Maarten Kappelle, Head of Thematic Assessments at UNEP The report calls for greater investment in reducing the risks of wildfires; development of prevention and response management approaches to wildfires that address vulnerable, rural, traditional, and indigenous communities; and further refinements in remote sensing, including satellites, radar, and lightning detection. “To manage wildfires more successfully, we must take measures that would prevent them from becoming uncontrollable,” said Maarten Kappelle, Head of Thematic Assessments at UNEP. Image Credits: tph567/Flickr, hyde/Flickr, Paul VanDerWerf/Flickr, UNEP, Project LM/Flickr. EU Health Commissioner Calls for More Preparedness on Eve of EU-AU Summit 17/02/2022 Paul Adepoju & Elaine Ruth Fletcher Charles Michel, President of the European Council European Union President Charles Michel congratulated African countries for their efforts to stimulate more vaccine manufacturing capacity on the continent, in a upbeat opening address at the European Union-African Union Summit, which began Thursday. But in a more sobering note Wednesday, Stella Kyriakides, the European Commissioner for Health and Food Safety, called on global health players to prioritize preparations for the next pandemic. “The pandemic has been a challenge for all of us. For our citizens, for our societies,” Michel said in his opening remarks at the Summit in Brussels. “It opened our eyes and showed us our strengths, our weaknesses, our successes, our failures.” European Union-African Union Summit opens, 17 Feb 2022 Against those challenges, he lauded the recent AU moves on achieving more vaccine self-sufficiency: “We have to look at what you have been doing in the African Union. In less than a year, you launched the manufacture of four vaccines to reduce pharmaceutical dependence on the African continent. And this is a project you devised for Africans, by Africans. Vaccine production capacity has been set up in South Africa, Senegal and Rwanda.” “For us as Europeans, we should be looking at a new way of working, of cooperating with you.” Michel was referring to BioNTech’s announcement Wednesday that it would set up modular “BioNTainer” vaccine production facilities in Rwanda and Senegal by mid-2022. That, in addition to South Africa’s production of the J&J vaccine, and a new WHO-backed mRNA vaccine hub in South Africa, which was the focus of a high-level WHO visit last week. In its gala event in Marburg, Germany on Wednesday, BioNTech executives said they will ship the plug-and-play vaccine facilities to Rwanda and Senegal in 2 modules of six standard freight containers, by mid-2022. The BioNTech announcement has been praised by leading African Union figures, including Africa CDC’s John Nkengasong and special envoy Michel Sidibé. Privilege to participate yesterday in 🇩🇪 alongside my brothers @Macky_Sall,@PaulKagame, @NakufoAddo,@NEPAD_Mayaki in a presentation on the @BioNTech_Group Vaccine Equity for Africa initiative.This world-class techn transfer will manufacture 💉 mRNAs in Africa. @KenupFoundation👏 pic.twitter.com/a1T01fFRDX — Michel Sidibé (@MichelSidibe) February 17, 2022 South Africa’s dilemma But not everyone may be as delighted about the BioNTech initiative. Although South Africa was explicitly mentioned as a third “possible” participant in a BioNTech press release – President Cyril Ramaphosa was noticeably absent from the stage of Wednesday’s launch in Marburg – which featured the heads of state of Senegal, Rwanda and Ghana – alongside WHO and Africa CDC. Entering the Brussel’s summit on Thursday, Ramaphosa told reporters that he remains interested in pushing ahead on discussions about a temporary waiver of intellectual property restrictions on COVID-19 vaccine production. “We are going to discuss the TRIPS waiver,” he shouted back to a press pool – in reference to the hotly-debated waiver that has been sitting before the World Trade Organization TRIPS for over a year now. Arriving #EUAU summit, @devex (me) asks @CyrilRamaphosa whether summit will be success without TRIPS waiver. “We will discuss it” x 2. Is he convinced by European offer on vaccine equity, “no, not yet.” pic.twitter.com/p1Bq31GLxp — Vince Chadwick (@vchadw) February 17, 2022 ‘Not yet’ convinced by Europe’s moves While Ramaphosa acknowledged that Europe had stepped up its vaccine donations, he said that he was “not yet” convinced by the European moves. “We need to move through the TRIPS dispensation where we can make our own vaccines, and that will be very important,” said the South African leader who has placed his vaccine production bets on a new WHO-supported mRNA vaccine technology transfer hub, that would develop open-access brands of mRNA vaccines for not only COVID, but other diseases. That hub is centered around a group of Cape Town research and manufacturing institutions. But some of the hub’s success will depend on how easily it can navigate around existing patent rules on some cutting edge products, like mRNA COVID vaccines. Meanwhile, the TRIPS waiver has been staunchly opposed by leading EU countries, such as Germany, as well as by pharma groups that say bilateral deals between country and the private sector are a more stable basis for sustainable expansion of production capacity. Invest in health systems – prepare for the future Stella Kyriakides, the European Commissioner for Health and Food Safety Speaking Wednesday on the eve of the Summit at the 7th EU-Africa Business Forum 2022, Kyriakides stressed that governments need to invest now in measures that can help prepare for future threats, which are sure to come. “We must not wait and be complacent. But we need to prepare today for future health emergencies,” Kyriakides said. Kyriakides noted that while on its part, the EU has been introducing reforms to strengthen a “European Health Union”, the pandemic has expanded awareness that regional preparedness is no longer sufficient. “In order for us to be truly prepared for emerging health threats, we need to be prepared globally,” she said. In a related move, the European Investment Bank also pledged Thursday to commit some €500 million to a joint WHO-EU initiative strengthening African health systems on the continent. Most countries continue to fall far short of the longstanding Abuja Declaration to allocate 15% of national government spending on health – and the pandemic has created further setbacks. Two Years Into COVID Pandemic, 92 % Of Countries Still Face Significant Health Service Disruptions – Health Policy Watch https://t.co/GPXrhKpLpT via @HealthPolicyW pic.twitter.com/crGfmwzxQM — African Health Observatory Platform (@AHOPlatform) February 17, 2022 Partnering with the African Union Against that context, the EU wants to partner more with the African Union on challenges highlighted by the pandemic, such as the need to reinforce global disease surveillance, and building capacity to undertake emergency countermeasures. She also pledged the EU’s readiness to assist in building up preparedness by supporting the African Medicines Agency (AMA) and the African Preparedness and Response Authority (APRA). She called for the diversification of international supply chains and the resolution of bottlenecks in addition to the expansion of global production of vaccines and therapeutics. “Team Europe”, which includes the EU, EU Member states and European financial institutions, is supporting Africa in this regard with more than €1 billion to create an enabling environment for African vaccine manufacturing, and to tackle barriers related to supply chains and demand, she noted. She also highlighted that the ongoing partnership between the European Centre for Disease Prevention and Control (ECDC) and the Africa CDC is resulting in mutual learning and improved health security for everyone. The COVID-19 pandemic has also strengthened the mandate of the ECDC so it will be able to support epidemic and outbreak responses, and establish a more structured cooperation with public health actors in Africa. Pledging the EU’s contined support for the AMA, she described its creation as a crucial moment in Africa’s journey towards a strengthened regulatory system, which will ultimately contribute to the promotion of sovereignty in Africa. The COVID-19 pandemic has highlighted the need to build healthier, more resilient and more equitable societies, Kyriakides also underlined. But to achieve this, a number of ingredients are essential: “They include the availability of vaccines and therapeutics, but also innovation, data and information sharing. And equally important are the sustainable and locally led development as well as a reformed Global Health architecture. The key ingredient though, are partnerships, trusted and effective collaboration, which needs to be based on the exchange of ideas of experiences and perspectives,” she concluded. Summit – focus on health systems and vaccine production Health is just one of about eight themes of focus at the two-day Summit – along with education, agriculture, climate change, finance and global governance. But in the wake of the destabilization created by the pandemic it clearly has even greater importance to participants now – in comparison with past years. Always pleased to meet my brother @AUC_MoussaFaki, Chair of the @_AfricanUnion. We discussed the importance of scaling up vaccine production in Africa to deliver #VaccinEquity, as well as strengthening @AfricaCDC and African Medicines Agency. @WHO will continue its support. pic.twitter.com/qXVjWruhVb — Tedros Adhanom Ghebreyesus (@DrTedros) February 17, 2022 The EU and AU leaders also are meeting against the backdrop of high regional geopolitical tensions – posed by the continuing threat of a Russian invasion of Ukraine. A Summit press briefing reaffirmed the prior EU commitment to provide 700 million vaccine doses by mid-2022 to developing countries, of which at least 450 million would go to Africa. “Team Europe has exported more than half of its production since the crisis began; it supported the creation of ACT-A [the WHO-supported Act Accelerator] which has delivered more than one billion doses (including 350 million vaccines for Africa). And European countries have shared doses destined for their own citizens, including 125 million to African countries where it is the principal donor.” Emmanuel Macron, President of France Along with Charles Michel, the Summit is being hosted by the President of the European Commission, Ursula von der Leyen and French President Emmanual Macron, whose country currently holds the rotating presidency of the EU Council. In his keynote remarks before the Summit, Macron also reaffirmed the need to support African health systems, wrought by the COVID-19 pandemic. “The COVID-19 pandemic has thrown all of our agenda into the air. It’s been more difficult for African countries to deal with COVID because it is a health, economic and social crisis which has been brought to bare on more fragile economies which are on the verge of development, making it even more costly. African budgets do not have the ability to absorb these shocks as ours do,” said the French president. European Investment Bank Pledges €500 million to WHO-EU Partnership for Stronger African Health Systems 17/02/2022 Editorial team WHO DG Tedros Adhanom Ghebreyesus and EIB President Werner Hoyer. The European Investment Bank said Thursday that it would commit €500 million to improving African health systems, as part of a new initiative with the World Health Organization and the European Union. The joint EIB-WHO-EU statement coincided with the start of an EU-African Union Summit, which is set to talk about how to improve health systems in Africa, as well as stepping up vaccine production. While there have been some recent, big strides to jump-start more African vaccine manufacturing and related R&D, including in the WHO-supported South African mRNA hub and a BioNTech modular vaccine manufacturing initiative, announced only yesterday (hyperlink please to those two stories), much less attention has been focused on health systems, which are the backbone for service delivery. And recent data suggests that African health systems, like others worldwide, continue to suffer setbacks in delivery of other routine services, due to the pandemic. Two Years Into COVID Pandemic, 92 % Of Countries Still Face Significant Health Service Disruptions – Health Policy Watch https://t.co/GPXrhKpLpT via @HealthPolicyW pic.twitter.com/crGfmwzxQM — African Health Observatory Platform (@AHOPlatform) February 17, 2022 That, along with being chronically underfinanced – with most countries far from the Abuja goal of investing 15% of GDP in health services. Only two countries – Rwanda and South Africa – had reached the 15% target in 2011, while seven had actually reduced their health budgets proportionate to their national budgets. The situation had deteriorated further in 2016, with 19 African countries spending less on health as a percentage of their public spending than in the early 2000s. According to the 2016 WHO report, countries with high per capita income such as Algeria, Botswana, South Africa, and Seychelles, do not systematically spend more of their budgets on health, while lower income countries such as Ethiopia, Gambia, and Malawi – have in fact surpassed the 15% goal. The new initiative aims to address both the pandemic-related and more systematic issues, said a WHO press statement on the EIB investment. It noted that the investments would be focused on “restoring, expanding and sustaining access to essential health services and increasing financial risk protection; access to vaccines, medicines, diagnostics, devices and other health products; scaling innovative primary health care service delivery models and investing in a health workforce to deliver effective quality care. “The shared goals of the partnership will achieved by applying a country-led and country-driven approach, identifying gaps in national health systems, designing strategies for interventions and their corresponding investments plans, investing in health system projects and programmes, convening capital providers, supporting implementation and monitoring impact,” said WHO. EIB President Werner Hoyer, said that the goal of the initiative is to mobilize €1 billion of new investment “to strengthen public health across Africa.” Said WHO Director General Dr Tedros Adhanom Ghebreyesus: “The COVID-19 pandemic is a powerful demonstration that when health is at risk, everything is at risk. Investing in health across Africa is therefore essential not just to promote and protect health, but also as a foundation for lifting people out of poverty and driving inclusive economic growth.” Image Credits: EIB/Twitter. BioNTech To Ship Modular mRNA Vaccine Facilities in Containers to African Countries to Jump-start Production 16/02/2022 Elaine Ruth Fletcher Display in Marburg Germany of the BioNtainer container that will be shipped to Africa to jump-start mRNA vaccine manufacturing on the continent. The German-based BioNTech, which co-developed with Pfizer an mRNA COVID vaccine, said on Wednesday that it will set up modular “turnkey” mRNA vaccine facilities to produce the vaccine in Rwanda and Senegal in 2022 – with a fill-and-finish collaboration in Ghana as well. South Africa, which is the new hub for the WHO-supported mRNA vaccine R&D and manufacturing hub focusing on open-access products- may also join the initiative later, said the company in a press release. Speaking at a press briefing Wednesday morning, which included the presidents of Rwanda, Ghana and Senegal, as well as WHO and Africa CDC, BioNTech CEO Ugur Sahin, described the new cutting-edge BioNTainer initiative for vaccine production as – following “the most elementary principle of reducing complexity by copying the manufacturing units having modular action unit and by copying the process and transferring it to another place. “But this is not about innovation alone, it it is about collaboration,” Sahin added, “for example, implementation of the manufacturing side, about regulation, about supply of vaccines… no one can do it alone, we have to do it together,” Sahin said. He said that the first containers would be delivered to Africa in mid-2022 “and we want to start with the manufacturing of the first vaccine batches in the first months after we deliver the containers.” The new production facilities are designed to produce not only COVID-19 vaccines, but other “future vaccines” in the planning for malaria, tuberculosis and HIV: “If these vaccines are successful and approved they will be produced in Africa, and these containers can be useful.” Welcomed by African leaders Left to right: BioNTech CMO Özlem Türeci and CEO Ugur Sahin; with African heads of state, Nana Akufo-Addo (Ghana); Macky Sall (Senegal) and Paul Kagame (Rwanda) and WHO’s Director General Tedros Adhanom Ghebreyesus; and kNUP’s Holm Keller at BioNtech briefing on new BioNTainer plug-and-play facility. The initiative was roundly welcomed by the heads of Ghana, Senegal, Rwanda – all of whom were present at the briefing – as well as the heads of WHO and Africa CDC. “Today is a historic day. Today, we are putting an end to the vaccine injustice that has occurred during the pandemic, where Africa was left by the wayside,” said Senegal’s President Macky Sall, who opened Wednesday’s public briefing in Marburg, Germany, where the three African heads of state had been meeting with BioNTech officials over the past several days on the BioNtainer concept. “Thanks to the innovation of BioNtech, with the BioNtainer, we are going to transfer the technology to Africa, to produce the API for the mRNA vaccines, along with the fill-and-finish. And we can thus be able to produce COVID-19 vaccines, as well as having the potential to produce vaccines for other diseases,” he said. “We commend this cooperation between Europe and Africa, between BioNTech and African countries, as well as foundations and development banks that are providing the financial backing, so that we can very soon produce these vaccines on our continent.” Africa CDC head John Nkengasong also welcomes the new BioNTech initiative Meanwhile, Africa CDC head John Nkengasong praised BioNTech for “showing leadership” on the innovative ‘turn key’ production facilities, saying, “You are teaching us how to fish, and not giving us a fish….The African Union and Africa CDC will continue to work with you in this journey.” And Ghana’s President Nana Akufo-Addo, said his country would be dedicating it’s National Vaccine Institute to support the initiative to develop “partnerships for vaccine deployment and manufacturing in areas of funding, clinical trials and fill-and-finish capacity.” Ghana will set up a fill-and-finish facility soon, he said, in order to perform the last step of the BioNTech process – to be completed outside of the modular vaccine factory containers. BioNTainer concept explained at BioNTech press briefing on Wednesday 16 February 2022 WHO affirms initiative has African “ownership” Meanwhile, WHO’s Director General Dr Tedros Adhanom Ghebreyesus expressed support for the new project – despite the criticism that had been levelled at it in a recent BMJ investigation, which had portrayed it as a potential competition to the new WHO-supported mRNA vaccine manufacturing hub set up in South Africa, which aims to promote an open-license approach to vaccine manufacturing – in contrast to collaborations built around the bilateral licensing of patented products, such as Pfizer’s. Tedros visited the South African mRNA hub, which has replicated a version of the Moderna mRNA vaccine, just last Friday. “Many colleagues have been discouraged about the success of this project,” said Tedros, in an oblique reference to the earlier criticism levelled at the notion of shipping ready-made vaccine facilities in containers to Africa. He underlined that the endorsement by African national and African Union leaders shows that the BioNTech initiative is viable: “Their presence shows political commitment, their presence shows ownership. And when projects are owned and political commitment is provided from the leaders, projects normally succeed…. failure is not an option for this project, from what I observed,” said Tedros. .@DrTedros @WHO in oblique reference to prior @BMJ criticism of the initiative says "many colleagues have been discouraged about the success of this project….one thing that convinces me is that the presence of these leaders – their presence shows ownership." https://t.co/0GvaqaRSJ9 pic.twitter.com/lZFEBRQmiD — Health Policy Watch – Global Health News Reporting (@HealthPolicyW) February 16, 2022 ‘Miniaturized’ and standardized mRNA production BioNTech COO Sierk Poetting at a meeting briefing on the BioNTainer initiative. The new manufacturing systems effectively takes advantage of the comparatively small size of mRNA vaccines inputs, and their unique production technology, to “miniaturize” and standardise the vaccine production process, said BioNTech’s BioNTech Chief Operating Office (COO) Sierk Poetting at a press conference later Wednesday afternoon. He said innovation had been developed at Pfizer’s Marburg, Germany facility, which is Pfizer’s largest manufacturing operation, and would also now serve as global quality control center for the plug-and-play systems sent to Africa. The modular facilities would be built of ISO-standard 40 foot containers “We can put them on trucks, boats, or planes and ship those manufacturing BioNtainers to the world, to the target locations,” said Poetting. “The power of the mRNA drug class is that it is versatile and can be prepared rapidly,” said Sahin, noting that the facilities would also serve the production of future mRNA vaccines under development by Pfizer for other diseases. Turnkey facilities will be pre-approved as GMP complaint in Germany Turnkey facilities will be pre-approved as GMP compliant in Germany and then shipped to Africa – BioNTech CEO Sahin Sahin said that the modular facilities could be pre-approved as GMP compliant at Pfizer’s Marburg, Germany plant where the turnkey solution was developed – and which will supervise the initiative: “The turnkey package includes the modular production unit, GMP compliance set up, and personnel training to ensure that we can transfer the technology,” he explained. “The elements of the container-based, plug-and-play approach was modular design.. by having this standardized design, we can ensure that the facility, once approved somewhere, can be transferred to another place, and with a little additional work, the process can be GMP [compliant]. That means that the facility would be built and pre-approved to meet European manufacturing requirements, and once transferred to Africa, could be quickly approved by national regulatory processes as well, ensuring a quick start to manufacturing, said Sahin. Turnkey facility includes “plug and play” production meeting GMP standards, said BioNTech’s Ugur Sahin, at the press conference. There would be six containers – six for producing the active pharmaceutical ingredient and six more for producing the final drug product. They would be set up in an air-conditioned factory hall, equipped with refrigeration and other basic infrastructure, Poetting explained. ‘Fill and finish’ would take place at other sites in collaboration with national and local African partners. Sahin said that the first facility would be set up in mid-2022, with the aim of being fully operational by the end of the year. The facilities could produce up to 50 million doses a year – although actual production would vary by demand. Products would be sold at cost in African Union countries. “The goal of the BioNtainer is to reduce the cost and the speed of the development of manufacturing facilities, and provide a solution which is suitable for the needs of people living in this region,” said Sahin. Did BioNTech’s kENUP consultants try to undermine South Africa’s mRNA vaccine hub? Tedros visits Stellenbosch University’s Biomedical Research Institute & Centre for Epidemic Response & Innovation on 11 February, 2022, part of South Africa’s WHO co-sponsored mRNA vaccine hub. Asked why BioNTech had decided not to share Pfizer’s vaccine technology with the new WHO-supported mRNA vaccine tech transfer hub in South Africa, Poetting said that the company would collaborate by taking staff that are trained there to help manage the new BioNTech manufacturing facilities – which would initially be staffed by Pfizer’s European teams. “We will onboard the local teams and do the knowledge transfer and the production together,” Poetting said, adding, “we are actually collaborating with the transfer hubs. We will work together with the transfer hubs on staffing the units, on training the units, and for distribution of the units” he said. But for actual production processes, the BioNTainer facilities could be set up and become operational sooner, he asserted. Meanwhile, Sahin refused to comment on the recent allegations, published in The BMJ that the kENUP Foundation, a BioNTech consultancy that helped develop the BioNTainer initiative, had actually sought to undermine the South African tech transfer hub – which along with training African scientists and technicians also aims to develop open-access versions of mRNA vaccines. Holm Keller of the kENUP Foundation, moderating BioNTech’s launch of its new “BioNTainer’ initiative on Wednesday; kENUP is also alleged to have sought the “termination” of the WHO-supported South African mRNA hub. According to The BMJ, kENUP had sent a mission report to the South African government after a visit last August, saying that the hub’s project “of copying the manufacturing process of Moderna’s COVID-19 vaccine should be terminated immediately. This is to prevent damage to Afrigen, BioVac, and Moderna . . . “Provided that the release from patent cover will be granted by Moderna only during the pandemic, the sustainability outlook for this project of the WHO Vaccine Technology Transfer Hub is not favourable,” stated the report, obtained by The BMJ. Scientists at Afrigen have since said that they managed to replicate the Moderna mRNA vaccine – without assistance from the US-based pharma firm, which has nonetheless promised not to enforce its patents on its COVID-19 vaccine during the pandemic. “We can’t comment on behalf of kENUP, and also not on behalf of WHO,” Sahin said. “We can just state that at the moment several projects with the same goal are underway, and we welcome any projects with the same goals. What is important at the beginning, of course, to understand the overall framework, and what are the specific aspects of the individual partners, and identify ways to collaborate.” New projects on African continent – a turning point… In fact, the silver lining in the vaccine inequalities in Africa, sharply highlighted by the COVID pandemic, is the surge of new vaccine manufacturing initiatives, said Greg Perry, Assistant Director of the International Federation of Pharmaceutical Manufacturers and Associations, in a comment to Health Policy Watch. “What is significant is how much is happening on the African continent, and much from private sector, from J&J ‘s agreement with Aspen Pharmacare, to the BioNTech- Biovac partnership on manufacturing and distribution activities, to the various BioNTech actions announced today,” he said. He made his comment shortly after the new head of Tanzania, formerly one of the continent’s most COVID vaccine-hestitant countries, said that it, too, would like to set up a vaccine manufacturing plant to tackle COVD and other diseases. New President, Samia Suluhu Hassan described her plans at a meeting with European Union President Charles Michel in Brussels, BBC reported. Meanwhile, in Nigeria, a vigorous debate over the creation of a national vaccine manufacturing initiative is also underway. “We should be open to all these initiatives,” Perry said. “But what is key is that are long term, sustainable, and based on voluntary partnership. Moreover they will all face the same challenges, needs for skills and regulatory support; long- term financing and demand stability. It’s these real challenges and solutions we are talking about in Brussels this week at the European-African Business Forum,” he said, referring to a pharma meeting ongoing this week ahead of European Union-African Union summit. Ont the other side of the fence, pharma critics that have looked at the South African mRNA hub, as the seedling from which new patent-free modes of vaccines manufacture might take root and flourish on the continent, were not so enthusiastic about the new BioNTech initiative. “When local production in Africa is done under monopoly control of Pfizer/BioNtec, how does that increase technological autonomy and resilience?” asked Els Torreele, a visiting fellow at the Institute for Innovation and Public Purpose at University College London, in a tweet. https://twitter.com/ElsTorreele/status/1493974017967067142 Image Credits: BioNTech, BioNTech , @StellenboschUni, BioNTech Press conference . Depression Remains Overlooked and Underfunded; Experts Call to Reduce Global Burden 16/02/2022 Raisa Santos Street scene in Metro Manila, Intramurous district, Philippines. 80-90% of those with depression are left untreated or undiagnosed in low- and middle-income countries. Homelessness is one adverse experience that may cause depression. With about half of people suffering from depression in high income countries untreated or undiagnosed, with this number rising to 80-90% in low- and middle-income countries, a Lancet and World Psychiatric Association Commission have called for a unified response against this global crisis to reduce the burden of depression. Depression is estimated to impact 5% of adults globally, with its onset most frequent in young people. COVID-19 has caused ‘mass trauma’ worldwide and has further worsened mental health for millions, creating additional challenges with isolation, bereavement, uncertainty, hardship, and limited access to healthcare. To combat the crisis, the Commission’s ‘Time for united action on depression’ calls for a concerted and collaborative front from all – government, healthcare providers, researchers, and people living with depression, to improve care and prevention, fill knowledge gaps, and increase awareness for one of the leading causes of avoidable suffering and premature death worldwide. “Depression is a global health crisis that demands responses at multiple levels,” said Commision Chair Professor Helen Herrman. “This Commission offers an important opportunity for united action to transform approaches to mental health care and prevention globally.” The report is authored by 25 experts across 11 countries, from experts in neuroscience to global health. It is advised by people with experience of depression. Myths surrounding depression fuel inaction Myths surrounding mental health have fueled inaction. While 70-80% of people who die by suicide in high income countries, and around half in LMIC, suffered from mental illness, with depression as the most common cause, myths surrounding this health condition have fueled global inaction towards depression. The myths include the misconception that depression is simply sadness, a sign of weakness, or restricted to certain cultural groups. Depression also has an under-recognized social and economic toll, with the loss in economic productivity linked to depression costing the global economy an estimated $1 trillion a year. “There is arguably no other health condition which is as common, as burdensome, as universal, or as treatable as depression, yet it receives little policy attention and resources”, said Commission Co-Chair Associate Professor Christian Kieling, of the Brazil-based Universidade Federal do Rio Grande do Sul. The Commission does stress that depression is distinctly a health condition that is characterized by persistence, as it inhibits daily functioning and may lead to long-term health consequences. Depression may also impact anyone, regardless of gender, background, social class, and age, though symptoms and signs of depression may vary among groups. Society and individual strategies proposed Mental health services for children and adolescents have been disrupted due to COVID-19. Solutions to reduce the global burden of depression need to prevent adverse experiences in childhood. Whole-of-society and individual level strategies have been proposed by the Commission to prevent depression, focusing on reduced exposure to adverse experiences in childhood, lifestyle factors, and other stressful events, including financial crisis or bereavement. “Prevention is the most neglected aspect of depression. This in part because most interventions are outside of the health sector”, said co-author Dr Lakshmi Vijayakumar from SNEHA, Suicide Prevention Centre and Voluntary Health Services of Chennai, India. Vijayakumar further noted how crucial these prevention efforts are. “In the face of the lifelong effects of adolescent depression, from difficulty in school and future relationships to risk of substance abuse, self-harm, and suicide, investing in depression prevention is excellent value for money. It is crucial that we put into practice evidence-based interventions that support parenting, reduce violence in the family, and bullying at school, as well promoting mental health at work and addressing loneliness in older adults.” Current classification of depression is ‘too simplistic’ The current classification that places people with symptoms of depression into just two categories – either they have clinical depression or not – remains too simplistic, says the Commission. Instead, the Commission supports a personalized, staged approach to depression care that tailors and recommends interventions to the individual and the severity of their condition. These treatments range from self-help to lifestyle changes to psychological therapies. “No two individuals share the exact life story and constitution, which ultimately leads to a unique experience of depression and different needs for help, support, and treatment”, explained Commission Co-Chair Professor Vikram Patel from US-based Harvard Medical School. In addition, the Commission also proposes collaborative care strategies that incorporate locally recruited, widely available non-specialists such as community health workers and lay counselors. Ultimately, they conclude that greater investment is needed on behalf of the government to reduce the damaging impact of poverty, gender inequity, and other social inequalities on mental health. Said Patel: “Tackling the climate emergency, the COVID-19 pandemic and other global and regional emergencies that exacerbate existing inequities and threats to health, including pursuit of the UN Sustainable Development Goals, must also be vital parts of efforts to prevent depression.” Image Credits: Wayne S. Grazio, Nenad Stojkovic/Flickr, WHO/NOOR/Sebastian Liste. US and Africa Plan to Harness PEPFAR Networks to Increase COVID Vaccine Uptake 15/02/2022 Kerry Cullinan US Secretary of State Antony Blinken CAPE TOWN – The US and Africa intend to use the well-established community networks supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) to improve the uptake of COVID-19 vaccines in Africa. The initaitive would build upon the infrastructure developed since PEPFAR entered as a major player on the African AIDS scene in 2003. In addition, USAID has launched an initiative called Global VAX to support the World Health Organization (WHO) target of vaccinating 70% of the world’s population by mid-year against COVID-19, and will soon be announcing priority countries in Africa. This is according to US State official Mary Beth Goodman, who briefed African journalists on Tuesday on the COVID-19 Global Action Meeting convened by US Secretary of State Antony Blinken on Monday. “We’re leveraging opportunities through things like PEPFAR, which has an extraordinary network across the African continent in combating HIV/AIDS and has a network of community workers and leaders who are helping to work with us to also talk about some of the importance of COVID,” said Goodman, who is Acting Coordinator for Global COVID-19 Response and Health Security at the US Department of State. “The same is true of our Presidential Malaria Initiative and other efforts that have long been in place on the continent. “We actually have launched through USAID and the Centre for Disease Control, a programme that we’re calling Global VAX,” added Goodman. “The effort behind Global Vax is all about the uptake issues. How do we turn vaccines into vaccinations? How do we connect the dots to make sure that we are getting these vaccines distributed in a way that allows more people to have the opportunity to take the vaccine and that allows some of these countries which are lagging to meet the 70% target?” Blinken’s six-point ‘GAP’ plan Ghanian health worker Evelyn Narkie Dowuona holds up her COVID-19 vaccination card. Blinken presented a six-point COVID-19 Prioritized Global Action Plan for Enhanced Engagement (GAP) to foreign ministers and senior leaders from countries and international organizations invited to his virtual meeting. “Together, we identified urgent gaps in response activities and aligned around specific roles to advance global efforts aimed at bringing this pandemic under control and strengthening readiness for future global health threats. We agreed that more political leadership is needed to save lives and end this pandemic cycle in 2022,” said Blinken in a statement issued late Monday. He identified the “six lines of the global effort to respond to acute pandemic needs” as: Getting Shots in Arms: coordinated efforts to improve vaccine readiness and logistics, in step with increased donations and procurement, toward the goal of at least 70% of the population fully vaccinated with quality, safe, and effective vaccines by September 2022. Bolstering Supply Chain Resilience: mechanisms to facilitate sufficient and steady supplies of critical products and materials to break this cycle of the COVID-19 pandemic, including establishing mechanisms to identify and remove medical supply chain bottlenecks. Addressing Information Gaps: global efforts to enhance vaccine confidence and combat the spread of false information, enlisting regional champions and medical, civil society, young people, and faith leaders to use evidence-based, accurate, locally relevant messaging. Supporting Health Workers: protecting the health, safety, and wellbeing of frontline health workers, including the need to improve their training and numbers to effectively support the COVID-19 response. Ensuring Acute Non-Vaccine Interventions, including the provision of therapeutics, testing regimes, and oxygen where needed most. Strengthening Global Health Security Architecture to end the current pandemic and. secure future preparedness for health emergencies at the national, regional and global level. Blinken also announced a direct donation of 5 million doses of Johnson & Johnson’s COVID-19 vaccine to the African Vaccine Acquisition Trust (AVAT), the African Union’s vaccine procurement and distribution effort. The US has now donated more than 155 million doses to Africa and 435 million doses worldwide. Praise for Uganda vaccine effort Ugandan Health Minister Dr Jane Ruth Aceng (left) and French Ambassador to Uganda Jules-Armand Aniambossou with donated AstraZeneca COVID-19 vaccines. In his address to the GAP meeting, Blinken praised Uganda for its massive vaccination effort in November and December last year as an example of what is possible. “In early November, only 14% of all Ugandan adults had received their first dose of the vaccine,” said Blinken. “Then a major team effort commenced. The Ugandan government led a mass vaccination campaign, carried out by hundreds of health care workers,” he added, and “by late December, almost half of all adults in Uganda had received their first shot – from 14 to 47% in just six weeks”. Participants in the GAP meeting included Australia, Canada, Colombia, France, Germany, India, Indonesia, Italy, Japan, the Republic of Korea, New Zealand, Saudi Arabia, Senegal, South Africa,Spain, UK, the African Union/Africa Centres for Disease Control, the European Commission, and the WHO. They have all committed to coordinating parts of the six key areas identified. Meanwhile, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the meeting that “in some countries, high vaccine coverage, combined with the lower severity of Omicron, is driving a false narrative that the pandemic is over”. However, the low vaccine coverage and low testing rates in other countries “are creating the ideal conditions for new variants to emerge”, warned Tedros, adding that 116 countries are off track to vaccinate 70% of the population by the middle of this year. “We can bring the pandemic under control this year – but we are at increased risk of squandering that opportunity,” said Tedros, adding that “in many countries, the issues are not primarily a problem of absorptive capacity. We need to urgently support political leaders to accelerate the rollout of vaccines”. Image Credits: WHO, Health Journalist Network. Malnourished Afghan Children in The Grasp of Measles Outbreak 15/02/2022 Shadi Khan A mother and her child in the Haji camp for internally displaced people in Kandahar, Afghanistan. More and more children are losing their lives to a measles outbreak in Afghanistan as the country struggles with a humanitarian crisis under the US sanctions on the country’s Taliban regime. Following the Taliban’s takeover of Afghanistan, the US Department of the Treasury froze Afghanistan Central Bank’s reserves, mostly held in US banks, as the Taliban has been on its “specially designated global terrorist group” since 2002, and any support for the group is illegal. The measles outbreak has hit the malnourished children hard in some of the already marginalized and poor communities in Paktika, Ghor, Badakhshan and other provinces of Afghanistan. The World Health Organization (WHO) last week confirmed that the number of cases and deaths increased by 18% in the week of 24 January, and 40% in the week of 31 January. Health Policy Watch reported last week that WHO Director-General Dr Tedros Adhanom Ghebreyesus met with the Taliban in Geneva to discuss Afghanistan’s health challenges. Struggle for meals in the pandemic According to the global health body, as many as 35,319 suspected cases of measles and 156 deaths have been reported in Afghanistan between 1 January 2021 and 29 January 2022. Of these, 3,221 cases were laboratory confirmed while 91% of these cases and 97% of these deaths were in children under five years of age. The WHO says that the rise in measles cases is especially concerning because of the extremely high levels of malnutrition in Afghanistan. This weakens immunity, making people more vulnerable to illness and death from diseases like measles – especially children. Local civil society activist in Paktika, Abdul Bari, mentioned that with the fall of the previous government, thousands of people lost their jobs and could not support families for months now that ultimately led to malnourishment and spread of the diseases. “Many families who were doing relatively well in the past now find them among the so many very poor in the society that struggle to feed one or two meals in Paktika”, he said. Mirwais Hospital, Kandahar – The hunger and poverty is more visible than ever in Afghanistan especially on the faces of the youngest victims of the crisis. Hospitals and healthcare facilities are filling up with babies and children suffering from malnutrition pic.twitter.com/J8B6VyEocS — Yalda Hakim (@SkyYaldaHakim) November 29, 2021 Authorities in Badakhshan province told the Health Policy Watch about an outbreak of measles worst affecting the remote Kuf Ab and Kohistan districts of the province where poverty is widespread. “The measles outbreak has been spreading in the province for the past two months and has spread to ten districts, including the capital Faiz Abad”, he said, adding that so far no organization or health institution has come to their aid and many children have died due to the disease in Kuf Ab and Kohistan districts. Equally remote and poor, Ghor province in the central highlands of Afghanistan is the second flashpoint for the measles outbreak according to the Afghan authorities. The provincial health department head, Mohammad Nazim, told the Health Policy Watch that more than a thousand children have been referred to the province’s central hospital recently and 21 of whom have died because of measles. “The reason for the spread of measles is the non-implementation of the vaccination program firstly due to the coronavirus pandemic and then the security concerns and lack of funds”, he said. Crumbling Healthcare System In December 2021, a measles outbreak response immunisation campaign was carried out with the support of the WHO in some of the most affected provinces, reaching 1.5 million children. Battling for survival, Afghanistan’s fragile health system has been on the edge for months in the wake of the COVID-19 pandemic, the Taliban takeover of power and the subsequent US freezing of Afghanistan’s state reserves. In Ghor, the regional public hospital sources said the doctors and support staff is so overstretched and under-paid that it can collapse any moment in the wake of mounting cases of COVID-19 and now the measles outbreak. Kabul-based paediatrician Dr Zar Wali told the Health Policy Watch that malnutrition among children was severely compromising their immune system. “On a daily basis I am receiving dozens of child patients from the city (Kabul) as well as the nearby provinces, and there is this clear pattern of malnourishment in almost all, which makes them susceptible to all sorts of diseases”. This was echoed by the UN Children Fund (UNICEF) last week when it warned that as the humanitarian crisis deepens in Afghanistan, hospitals were receiving so many cases each day of children suffering complications associated with severe acute malnutrition. After relatively low transmission in 2019 and 2020, new infection cases have been increasing in all provinces since the end of July 2021, with the highest weekly toll observed so far occurring over the last four weeks. The WHO has warned that although the number of deaths is relatively low, the rapid rise in cases in January 2022 suggests that the number of deaths due to measles is likely to increase sharply in the coming weeks. Being endemic in Afghanistan, more than 25,000 children get killed by the measles virus annually, according to the Ministry of Public Health, and many more struggle with its impacts. The WHO has expressed willingness to prepare a plan for a larger measles outbreak response immunisation campaign, which will start in May (or earlier, if possible), aiming to reach more than 3 million children in Afghanistan. Image Credits: © UNICEF Afghanistan. African Medicines Agency Host Country Could be Selected by July 15/02/2022 Kerry Cullinan Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD The African Union could decide on the host country for the African Medicines Agency (AMA) as early as July, while the agency’s director-general should be appointed by the end of the year. This is according to Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD, the African Union’s development agency. The AU Assembly had recently decided to “do an assessment of the countries that have offered to host the AMA headquarters”, she told a workshop convened by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on Monday ahead of the EU-AU Summit which starts in Brussels on Thursday. “The AU Commission and AUDA-NEPAD are working together, and the teams are set to go out in the first week of March,” said Ndomondo-Sigonda, adding that the country visits may take two months to complete. “Once they are done, then the assessment report will be presented before the first meeting of the Conference of the State Parties that is planned to be held sometime in May,” she added. Whatever decision is made by this body would have to go to the AU Assembly during its meeting in in June or July, “so by July we will know which countries actually hosting the headquarters for the African Medicines Agency,” she added. The Assembly comprises of all Member State Heads of State and Government is the AU’s supreme policy and decision-making organ. Director-General may be appointed by year-end As far as the appointment of the head of the AMA – its director general – is concerned, this would take a little longer. First, the Conference of the State Parties would have to consider the terms of reference for the position at its May meeting, and advertisements will only go out after that. “By the time we get to know who has been appointed as the director-general, it will probably be quarter three or quarter four this year,” she said. She added that AMA was being established as “a specialised agency of the African Union with its autonomy in terms of financial and human resources, so it’s going to be operating differently from what you see with Africa Centres for Disease Control at the moment”. Meanwhile, UNAIDS Executive Director Winnie Byanyima welcomed the imminent establishment of the AMA. “Since the very beginning of the COVID crisis, the multilateral response may have failed us but African leadership has been remarkable,” said Byanyima at a workshop on Monday. “The newly created African Medicines Agency will harmonise medicine regulations, and negotiate joint purchasing and the manufacture of our own medicines.” European and African Pharma Sector Want Permanent Platform to Support African Development 14/02/2022 Kerry Cullinan A staff member at Afrigen, the mRNA hub in South Africa, prepares part of the vaccine. The major players in the European and African pharmaceutical sectors have called on the European Union (EU) and the African Union (AU) to support the creation of a permanent “business platform” to foster the pharma industry’s development in Africa. This emerged at a workshop Monday hosted by the the European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) along with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and other European-based pharma associations. The workshop was part of the European African Business Forum (EABF) taking place ahead of, and along with, the European Union–African Union Summit, which begins Thursday in Brussels. The business platform should support the development of EU and AU policies conducive to trade and “sustainable financing mechanisms models with access to low-interest capital” and appropriate incentives to encourage local, regional and international private sector investment, according to IFPMA Assistant Director-General Greg Perry, speaking at the Monday EABF session leading up to the Summit. Businesses also want a “stable business environment that respects business ethics and incentivises local innovation and entrepreneurship, including through intellectual property, ensure development and retention of local skilled workforces”, said Perry, reading from a joint statement by the EABF’s Healthcare Working Group, which also includes the European Federation of Pharmaceutical Manufacturers and Associations (EPFIA) and Vaccines Europe. The pharmaceutical sector also wants voluntary and mutually agreed upon technology transfers and joint ventures; timely product registration, harmonisation of regulation particularly through the African Medicines Agency, and the implementation of the African Continental Free Trade Area to eliminate non-trade barriers and foster international supply chain security. “We believe that creating this platform with the support of the EU and the AU, we could facilitate African and European partnerships, support existing continental and regulatory initiatives and create a win-win for both Africa and Europe,” said Perry. Where is the money that was promised? Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee Emmanuel Mujuru, representing the Federation of African Pharmaceutical Manufacturers (FAPMA), said that the African pharmaceutical industry was struggling to access affordable financing. “This financing has to both long-term in nature and have affordable interest rates, either in the form of loans or equity participation in already established African pharma management companies,” said Mujuru. He added that there was a significant opportunity for European investors as between 70 and 90% of essential medicines consumed in Africa were imported and that the pharmaceutical sector was growing at over 10% per annum, second only to Asia. Merck’s Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee, said that while setting up fill and finish operations “is easy to implement in two years”, he had tried to do so in three different African countries but “local private sector investors have never been able to get access to any finance”. “Why? The International Finance Corporation has announced $4 billion for the local vaccine manufacturing and the European Commission has announced one billion Euros,” asked Bendhaou “We also have to invest in the health system capacity because otherwise, you can have a nice factory in in South Africa, a beautiful factory in Egypt, producing hundreds of millions of doses but if you don’t have a health system in place for the uptake and to absorb this capacity,” he added. What about Gavi subsidies? Biovac CEO Patrick Tippoo Meanwhile, Patrick Tippoo, CEO of the South African company, Biovac and part of the African Vaccine Manufacturing Initiative (AVMI) leadership, said that much of Africa’s vaccine supply “comes in a subsidised form, partially or completely by Gavi through UNICEF”. “We know that Gavi drives prices down to make vaccines more affordable so more vaccines can be purchased and therefore distributed,” said Tippoo “We have a current situation where about 40 of the 54 countries depend on this mechanism. And therefore the market in Africa is actually in Copenhagen, as some people say. “This is a structural thing that will have to be addressed because, in order to stimulate and incentivize technology transfers, investment in skills, development, regulatory capacity building – and all the things that we repeat ad nauseum – there needs to be an assurance that there’s going to be a market when all of this is built,” he stressed. Tippoo added that African governments and other stakeholders had to understand that a “resilience premium” would need to be paid to ensure that pharmaceutical manufacturing capability is built in Africa. “There is no way in which vaccines coming out of Africa in the next five or 10 years can compete on a cost of goods perspective, with Indian manufacturer factories, or even multinationals because they’ve monetised the investment over time, and they have economies of scale,” he added. Diversification a ‘win-win’ for Africa, Europe and globally However, other participants pointed out that over the long-term, diversification of sources for pharma procurement is going to be a win win, given the comparatively limited number of suppliers, for some key global health products. Interruptions to key medical supply chains were particularly evident during the early stages of the COVID pandemic, exposing their fragility, even for more affluent countries. Sibilia Quilici, Executive Director, Vaccines Europe, pointed out that from the European perspective, too, it would be beneficial to reduce dependence on what is now a comparatively small number of suppliers, mainly from India and China, and integrate Africa’s supply chains with global ones: “In the context of this discussion on improving manufacturing capacities in Africa, also for APIs [active pharmaceutical ingredients] it is good to be aware that the EU, the largest API importer in the world is looking for supply chain diversification for products where dependence on a small number of suppliers from India and China is a concern. “This could be a win-win for Africa, EU, local and global industry”. Image Credits: Rodger Bosch for MPP/WHO, WHO . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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EU Health Commissioner Calls for More Preparedness on Eve of EU-AU Summit 17/02/2022 Paul Adepoju & Elaine Ruth Fletcher Charles Michel, President of the European Council European Union President Charles Michel congratulated African countries for their efforts to stimulate more vaccine manufacturing capacity on the continent, in a upbeat opening address at the European Union-African Union Summit, which began Thursday. But in a more sobering note Wednesday, Stella Kyriakides, the European Commissioner for Health and Food Safety, called on global health players to prioritize preparations for the next pandemic. “The pandemic has been a challenge for all of us. For our citizens, for our societies,” Michel said in his opening remarks at the Summit in Brussels. “It opened our eyes and showed us our strengths, our weaknesses, our successes, our failures.” European Union-African Union Summit opens, 17 Feb 2022 Against those challenges, he lauded the recent AU moves on achieving more vaccine self-sufficiency: “We have to look at what you have been doing in the African Union. In less than a year, you launched the manufacture of four vaccines to reduce pharmaceutical dependence on the African continent. And this is a project you devised for Africans, by Africans. Vaccine production capacity has been set up in South Africa, Senegal and Rwanda.” “For us as Europeans, we should be looking at a new way of working, of cooperating with you.” Michel was referring to BioNTech’s announcement Wednesday that it would set up modular “BioNTainer” vaccine production facilities in Rwanda and Senegal by mid-2022. That, in addition to South Africa’s production of the J&J vaccine, and a new WHO-backed mRNA vaccine hub in South Africa, which was the focus of a high-level WHO visit last week. In its gala event in Marburg, Germany on Wednesday, BioNTech executives said they will ship the plug-and-play vaccine facilities to Rwanda and Senegal in 2 modules of six standard freight containers, by mid-2022. The BioNTech announcement has been praised by leading African Union figures, including Africa CDC’s John Nkengasong and special envoy Michel Sidibé. Privilege to participate yesterday in 🇩🇪 alongside my brothers @Macky_Sall,@PaulKagame, @NakufoAddo,@NEPAD_Mayaki in a presentation on the @BioNTech_Group Vaccine Equity for Africa initiative.This world-class techn transfer will manufacture 💉 mRNAs in Africa. @KenupFoundation👏 pic.twitter.com/a1T01fFRDX — Michel Sidibé (@MichelSidibe) February 17, 2022 South Africa’s dilemma But not everyone may be as delighted about the BioNTech initiative. Although South Africa was explicitly mentioned as a third “possible” participant in a BioNTech press release – President Cyril Ramaphosa was noticeably absent from the stage of Wednesday’s launch in Marburg – which featured the heads of state of Senegal, Rwanda and Ghana – alongside WHO and Africa CDC. Entering the Brussel’s summit on Thursday, Ramaphosa told reporters that he remains interested in pushing ahead on discussions about a temporary waiver of intellectual property restrictions on COVID-19 vaccine production. “We are going to discuss the TRIPS waiver,” he shouted back to a press pool – in reference to the hotly-debated waiver that has been sitting before the World Trade Organization TRIPS for over a year now. Arriving #EUAU summit, @devex (me) asks @CyrilRamaphosa whether summit will be success without TRIPS waiver. “We will discuss it” x 2. Is he convinced by European offer on vaccine equity, “no, not yet.” pic.twitter.com/p1Bq31GLxp — Vince Chadwick (@vchadw) February 17, 2022 ‘Not yet’ convinced by Europe’s moves While Ramaphosa acknowledged that Europe had stepped up its vaccine donations, he said that he was “not yet” convinced by the European moves. “We need to move through the TRIPS dispensation where we can make our own vaccines, and that will be very important,” said the South African leader who has placed his vaccine production bets on a new WHO-supported mRNA vaccine technology transfer hub, that would develop open-access brands of mRNA vaccines for not only COVID, but other diseases. That hub is centered around a group of Cape Town research and manufacturing institutions. But some of the hub’s success will depend on how easily it can navigate around existing patent rules on some cutting edge products, like mRNA COVID vaccines. Meanwhile, the TRIPS waiver has been staunchly opposed by leading EU countries, such as Germany, as well as by pharma groups that say bilateral deals between country and the private sector are a more stable basis for sustainable expansion of production capacity. Invest in health systems – prepare for the future Stella Kyriakides, the European Commissioner for Health and Food Safety Speaking Wednesday on the eve of the Summit at the 7th EU-Africa Business Forum 2022, Kyriakides stressed that governments need to invest now in measures that can help prepare for future threats, which are sure to come. “We must not wait and be complacent. But we need to prepare today for future health emergencies,” Kyriakides said. Kyriakides noted that while on its part, the EU has been introducing reforms to strengthen a “European Health Union”, the pandemic has expanded awareness that regional preparedness is no longer sufficient. “In order for us to be truly prepared for emerging health threats, we need to be prepared globally,” she said. In a related move, the European Investment Bank also pledged Thursday to commit some €500 million to a joint WHO-EU initiative strengthening African health systems on the continent. Most countries continue to fall far short of the longstanding Abuja Declaration to allocate 15% of national government spending on health – and the pandemic has created further setbacks. Two Years Into COVID Pandemic, 92 % Of Countries Still Face Significant Health Service Disruptions – Health Policy Watch https://t.co/GPXrhKpLpT via @HealthPolicyW pic.twitter.com/crGfmwzxQM — African Health Observatory Platform (@AHOPlatform) February 17, 2022 Partnering with the African Union Against that context, the EU wants to partner more with the African Union on challenges highlighted by the pandemic, such as the need to reinforce global disease surveillance, and building capacity to undertake emergency countermeasures. She also pledged the EU’s readiness to assist in building up preparedness by supporting the African Medicines Agency (AMA) and the African Preparedness and Response Authority (APRA). She called for the diversification of international supply chains and the resolution of bottlenecks in addition to the expansion of global production of vaccines and therapeutics. “Team Europe”, which includes the EU, EU Member states and European financial institutions, is supporting Africa in this regard with more than €1 billion to create an enabling environment for African vaccine manufacturing, and to tackle barriers related to supply chains and demand, she noted. She also highlighted that the ongoing partnership between the European Centre for Disease Prevention and Control (ECDC) and the Africa CDC is resulting in mutual learning and improved health security for everyone. The COVID-19 pandemic has also strengthened the mandate of the ECDC so it will be able to support epidemic and outbreak responses, and establish a more structured cooperation with public health actors in Africa. Pledging the EU’s contined support for the AMA, she described its creation as a crucial moment in Africa’s journey towards a strengthened regulatory system, which will ultimately contribute to the promotion of sovereignty in Africa. The COVID-19 pandemic has highlighted the need to build healthier, more resilient and more equitable societies, Kyriakides also underlined. But to achieve this, a number of ingredients are essential: “They include the availability of vaccines and therapeutics, but also innovation, data and information sharing. And equally important are the sustainable and locally led development as well as a reformed Global Health architecture. The key ingredient though, are partnerships, trusted and effective collaboration, which needs to be based on the exchange of ideas of experiences and perspectives,” she concluded. Summit – focus on health systems and vaccine production Health is just one of about eight themes of focus at the two-day Summit – along with education, agriculture, climate change, finance and global governance. But in the wake of the destabilization created by the pandemic it clearly has even greater importance to participants now – in comparison with past years. Always pleased to meet my brother @AUC_MoussaFaki, Chair of the @_AfricanUnion. We discussed the importance of scaling up vaccine production in Africa to deliver #VaccinEquity, as well as strengthening @AfricaCDC and African Medicines Agency. @WHO will continue its support. pic.twitter.com/qXVjWruhVb — Tedros Adhanom Ghebreyesus (@DrTedros) February 17, 2022 The EU and AU leaders also are meeting against the backdrop of high regional geopolitical tensions – posed by the continuing threat of a Russian invasion of Ukraine. A Summit press briefing reaffirmed the prior EU commitment to provide 700 million vaccine doses by mid-2022 to developing countries, of which at least 450 million would go to Africa. “Team Europe has exported more than half of its production since the crisis began; it supported the creation of ACT-A [the WHO-supported Act Accelerator] which has delivered more than one billion doses (including 350 million vaccines for Africa). And European countries have shared doses destined for their own citizens, including 125 million to African countries where it is the principal donor.” Emmanuel Macron, President of France Along with Charles Michel, the Summit is being hosted by the President of the European Commission, Ursula von der Leyen and French President Emmanual Macron, whose country currently holds the rotating presidency of the EU Council. In his keynote remarks before the Summit, Macron also reaffirmed the need to support African health systems, wrought by the COVID-19 pandemic. “The COVID-19 pandemic has thrown all of our agenda into the air. It’s been more difficult for African countries to deal with COVID because it is a health, economic and social crisis which has been brought to bare on more fragile economies which are on the verge of development, making it even more costly. African budgets do not have the ability to absorb these shocks as ours do,” said the French president. European Investment Bank Pledges €500 million to WHO-EU Partnership for Stronger African Health Systems 17/02/2022 Editorial team WHO DG Tedros Adhanom Ghebreyesus and EIB President Werner Hoyer. The European Investment Bank said Thursday that it would commit €500 million to improving African health systems, as part of a new initiative with the World Health Organization and the European Union. The joint EIB-WHO-EU statement coincided with the start of an EU-African Union Summit, which is set to talk about how to improve health systems in Africa, as well as stepping up vaccine production. While there have been some recent, big strides to jump-start more African vaccine manufacturing and related R&D, including in the WHO-supported South African mRNA hub and a BioNTech modular vaccine manufacturing initiative, announced only yesterday (hyperlink please to those two stories), much less attention has been focused on health systems, which are the backbone for service delivery. And recent data suggests that African health systems, like others worldwide, continue to suffer setbacks in delivery of other routine services, due to the pandemic. Two Years Into COVID Pandemic, 92 % Of Countries Still Face Significant Health Service Disruptions – Health Policy Watch https://t.co/GPXrhKpLpT via @HealthPolicyW pic.twitter.com/crGfmwzxQM — African Health Observatory Platform (@AHOPlatform) February 17, 2022 That, along with being chronically underfinanced – with most countries far from the Abuja goal of investing 15% of GDP in health services. Only two countries – Rwanda and South Africa – had reached the 15% target in 2011, while seven had actually reduced their health budgets proportionate to their national budgets. The situation had deteriorated further in 2016, with 19 African countries spending less on health as a percentage of their public spending than in the early 2000s. According to the 2016 WHO report, countries with high per capita income such as Algeria, Botswana, South Africa, and Seychelles, do not systematically spend more of their budgets on health, while lower income countries such as Ethiopia, Gambia, and Malawi – have in fact surpassed the 15% goal. The new initiative aims to address both the pandemic-related and more systematic issues, said a WHO press statement on the EIB investment. It noted that the investments would be focused on “restoring, expanding and sustaining access to essential health services and increasing financial risk protection; access to vaccines, medicines, diagnostics, devices and other health products; scaling innovative primary health care service delivery models and investing in a health workforce to deliver effective quality care. “The shared goals of the partnership will achieved by applying a country-led and country-driven approach, identifying gaps in national health systems, designing strategies for interventions and their corresponding investments plans, investing in health system projects and programmes, convening capital providers, supporting implementation and monitoring impact,” said WHO. EIB President Werner Hoyer, said that the goal of the initiative is to mobilize €1 billion of new investment “to strengthen public health across Africa.” Said WHO Director General Dr Tedros Adhanom Ghebreyesus: “The COVID-19 pandemic is a powerful demonstration that when health is at risk, everything is at risk. Investing in health across Africa is therefore essential not just to promote and protect health, but also as a foundation for lifting people out of poverty and driving inclusive economic growth.” Image Credits: EIB/Twitter. BioNTech To Ship Modular mRNA Vaccine Facilities in Containers to African Countries to Jump-start Production 16/02/2022 Elaine Ruth Fletcher Display in Marburg Germany of the BioNtainer container that will be shipped to Africa to jump-start mRNA vaccine manufacturing on the continent. The German-based BioNTech, which co-developed with Pfizer an mRNA COVID vaccine, said on Wednesday that it will set up modular “turnkey” mRNA vaccine facilities to produce the vaccine in Rwanda and Senegal in 2022 – with a fill-and-finish collaboration in Ghana as well. South Africa, which is the new hub for the WHO-supported mRNA vaccine R&D and manufacturing hub focusing on open-access products- may also join the initiative later, said the company in a press release. Speaking at a press briefing Wednesday morning, which included the presidents of Rwanda, Ghana and Senegal, as well as WHO and Africa CDC, BioNTech CEO Ugur Sahin, described the new cutting-edge BioNTainer initiative for vaccine production as – following “the most elementary principle of reducing complexity by copying the manufacturing units having modular action unit and by copying the process and transferring it to another place. “But this is not about innovation alone, it it is about collaboration,” Sahin added, “for example, implementation of the manufacturing side, about regulation, about supply of vaccines… no one can do it alone, we have to do it together,” Sahin said. He said that the first containers would be delivered to Africa in mid-2022 “and we want to start with the manufacturing of the first vaccine batches in the first months after we deliver the containers.” The new production facilities are designed to produce not only COVID-19 vaccines, but other “future vaccines” in the planning for malaria, tuberculosis and HIV: “If these vaccines are successful and approved they will be produced in Africa, and these containers can be useful.” Welcomed by African leaders Left to right: BioNTech CMO Özlem Türeci and CEO Ugur Sahin; with African heads of state, Nana Akufo-Addo (Ghana); Macky Sall (Senegal) and Paul Kagame (Rwanda) and WHO’s Director General Tedros Adhanom Ghebreyesus; and kNUP’s Holm Keller at BioNtech briefing on new BioNTainer plug-and-play facility. The initiative was roundly welcomed by the heads of Ghana, Senegal, Rwanda – all of whom were present at the briefing – as well as the heads of WHO and Africa CDC. “Today is a historic day. Today, we are putting an end to the vaccine injustice that has occurred during the pandemic, where Africa was left by the wayside,” said Senegal’s President Macky Sall, who opened Wednesday’s public briefing in Marburg, Germany, where the three African heads of state had been meeting with BioNTech officials over the past several days on the BioNtainer concept. “Thanks to the innovation of BioNtech, with the BioNtainer, we are going to transfer the technology to Africa, to produce the API for the mRNA vaccines, along with the fill-and-finish. And we can thus be able to produce COVID-19 vaccines, as well as having the potential to produce vaccines for other diseases,” he said. “We commend this cooperation between Europe and Africa, between BioNTech and African countries, as well as foundations and development banks that are providing the financial backing, so that we can very soon produce these vaccines on our continent.” Africa CDC head John Nkengasong also welcomes the new BioNTech initiative Meanwhile, Africa CDC head John Nkengasong praised BioNTech for “showing leadership” on the innovative ‘turn key’ production facilities, saying, “You are teaching us how to fish, and not giving us a fish….The African Union and Africa CDC will continue to work with you in this journey.” And Ghana’s President Nana Akufo-Addo, said his country would be dedicating it’s National Vaccine Institute to support the initiative to develop “partnerships for vaccine deployment and manufacturing in areas of funding, clinical trials and fill-and-finish capacity.” Ghana will set up a fill-and-finish facility soon, he said, in order to perform the last step of the BioNTech process – to be completed outside of the modular vaccine factory containers. BioNTainer concept explained at BioNTech press briefing on Wednesday 16 February 2022 WHO affirms initiative has African “ownership” Meanwhile, WHO’s Director General Dr Tedros Adhanom Ghebreyesus expressed support for the new project – despite the criticism that had been levelled at it in a recent BMJ investigation, which had portrayed it as a potential competition to the new WHO-supported mRNA vaccine manufacturing hub set up in South Africa, which aims to promote an open-license approach to vaccine manufacturing – in contrast to collaborations built around the bilateral licensing of patented products, such as Pfizer’s. Tedros visited the South African mRNA hub, which has replicated a version of the Moderna mRNA vaccine, just last Friday. “Many colleagues have been discouraged about the success of this project,” said Tedros, in an oblique reference to the earlier criticism levelled at the notion of shipping ready-made vaccine facilities in containers to Africa. He underlined that the endorsement by African national and African Union leaders shows that the BioNTech initiative is viable: “Their presence shows political commitment, their presence shows ownership. And when projects are owned and political commitment is provided from the leaders, projects normally succeed…. failure is not an option for this project, from what I observed,” said Tedros. .@DrTedros @WHO in oblique reference to prior @BMJ criticism of the initiative says "many colleagues have been discouraged about the success of this project….one thing that convinces me is that the presence of these leaders – their presence shows ownership." https://t.co/0GvaqaRSJ9 pic.twitter.com/lZFEBRQmiD — Health Policy Watch – Global Health News Reporting (@HealthPolicyW) February 16, 2022 ‘Miniaturized’ and standardized mRNA production BioNTech COO Sierk Poetting at a meeting briefing on the BioNTainer initiative. The new manufacturing systems effectively takes advantage of the comparatively small size of mRNA vaccines inputs, and their unique production technology, to “miniaturize” and standardise the vaccine production process, said BioNTech’s BioNTech Chief Operating Office (COO) Sierk Poetting at a press conference later Wednesday afternoon. He said innovation had been developed at Pfizer’s Marburg, Germany facility, which is Pfizer’s largest manufacturing operation, and would also now serve as global quality control center for the plug-and-play systems sent to Africa. The modular facilities would be built of ISO-standard 40 foot containers “We can put them on trucks, boats, or planes and ship those manufacturing BioNtainers to the world, to the target locations,” said Poetting. “The power of the mRNA drug class is that it is versatile and can be prepared rapidly,” said Sahin, noting that the facilities would also serve the production of future mRNA vaccines under development by Pfizer for other diseases. Turnkey facilities will be pre-approved as GMP complaint in Germany Turnkey facilities will be pre-approved as GMP compliant in Germany and then shipped to Africa – BioNTech CEO Sahin Sahin said that the modular facilities could be pre-approved as GMP compliant at Pfizer’s Marburg, Germany plant where the turnkey solution was developed – and which will supervise the initiative: “The turnkey package includes the modular production unit, GMP compliance set up, and personnel training to ensure that we can transfer the technology,” he explained. “The elements of the container-based, plug-and-play approach was modular design.. by having this standardized design, we can ensure that the facility, once approved somewhere, can be transferred to another place, and with a little additional work, the process can be GMP [compliant]. That means that the facility would be built and pre-approved to meet European manufacturing requirements, and once transferred to Africa, could be quickly approved by national regulatory processes as well, ensuring a quick start to manufacturing, said Sahin. Turnkey facility includes “plug and play” production meeting GMP standards, said BioNTech’s Ugur Sahin, at the press conference. There would be six containers – six for producing the active pharmaceutical ingredient and six more for producing the final drug product. They would be set up in an air-conditioned factory hall, equipped with refrigeration and other basic infrastructure, Poetting explained. ‘Fill and finish’ would take place at other sites in collaboration with national and local African partners. Sahin said that the first facility would be set up in mid-2022, with the aim of being fully operational by the end of the year. The facilities could produce up to 50 million doses a year – although actual production would vary by demand. Products would be sold at cost in African Union countries. “The goal of the BioNtainer is to reduce the cost and the speed of the development of manufacturing facilities, and provide a solution which is suitable for the needs of people living in this region,” said Sahin. Did BioNTech’s kENUP consultants try to undermine South Africa’s mRNA vaccine hub? Tedros visits Stellenbosch University’s Biomedical Research Institute & Centre for Epidemic Response & Innovation on 11 February, 2022, part of South Africa’s WHO co-sponsored mRNA vaccine hub. Asked why BioNTech had decided not to share Pfizer’s vaccine technology with the new WHO-supported mRNA vaccine tech transfer hub in South Africa, Poetting said that the company would collaborate by taking staff that are trained there to help manage the new BioNTech manufacturing facilities – which would initially be staffed by Pfizer’s European teams. “We will onboard the local teams and do the knowledge transfer and the production together,” Poetting said, adding, “we are actually collaborating with the transfer hubs. We will work together with the transfer hubs on staffing the units, on training the units, and for distribution of the units” he said. But for actual production processes, the BioNTainer facilities could be set up and become operational sooner, he asserted. Meanwhile, Sahin refused to comment on the recent allegations, published in The BMJ that the kENUP Foundation, a BioNTech consultancy that helped develop the BioNTainer initiative, had actually sought to undermine the South African tech transfer hub – which along with training African scientists and technicians also aims to develop open-access versions of mRNA vaccines. Holm Keller of the kENUP Foundation, moderating BioNTech’s launch of its new “BioNTainer’ initiative on Wednesday; kENUP is also alleged to have sought the “termination” of the WHO-supported South African mRNA hub. According to The BMJ, kENUP had sent a mission report to the South African government after a visit last August, saying that the hub’s project “of copying the manufacturing process of Moderna’s COVID-19 vaccine should be terminated immediately. This is to prevent damage to Afrigen, BioVac, and Moderna . . . “Provided that the release from patent cover will be granted by Moderna only during the pandemic, the sustainability outlook for this project of the WHO Vaccine Technology Transfer Hub is not favourable,” stated the report, obtained by The BMJ. Scientists at Afrigen have since said that they managed to replicate the Moderna mRNA vaccine – without assistance from the US-based pharma firm, which has nonetheless promised not to enforce its patents on its COVID-19 vaccine during the pandemic. “We can’t comment on behalf of kENUP, and also not on behalf of WHO,” Sahin said. “We can just state that at the moment several projects with the same goal are underway, and we welcome any projects with the same goals. What is important at the beginning, of course, to understand the overall framework, and what are the specific aspects of the individual partners, and identify ways to collaborate.” New projects on African continent – a turning point… In fact, the silver lining in the vaccine inequalities in Africa, sharply highlighted by the COVID pandemic, is the surge of new vaccine manufacturing initiatives, said Greg Perry, Assistant Director of the International Federation of Pharmaceutical Manufacturers and Associations, in a comment to Health Policy Watch. “What is significant is how much is happening on the African continent, and much from private sector, from J&J ‘s agreement with Aspen Pharmacare, to the BioNTech- Biovac partnership on manufacturing and distribution activities, to the various BioNTech actions announced today,” he said. He made his comment shortly after the new head of Tanzania, formerly one of the continent’s most COVID vaccine-hestitant countries, said that it, too, would like to set up a vaccine manufacturing plant to tackle COVD and other diseases. New President, Samia Suluhu Hassan described her plans at a meeting with European Union President Charles Michel in Brussels, BBC reported. Meanwhile, in Nigeria, a vigorous debate over the creation of a national vaccine manufacturing initiative is also underway. “We should be open to all these initiatives,” Perry said. “But what is key is that are long term, sustainable, and based on voluntary partnership. Moreover they will all face the same challenges, needs for skills and regulatory support; long- term financing and demand stability. It’s these real challenges and solutions we are talking about in Brussels this week at the European-African Business Forum,” he said, referring to a pharma meeting ongoing this week ahead of European Union-African Union summit. Ont the other side of the fence, pharma critics that have looked at the South African mRNA hub, as the seedling from which new patent-free modes of vaccines manufacture might take root and flourish on the continent, were not so enthusiastic about the new BioNTech initiative. “When local production in Africa is done under monopoly control of Pfizer/BioNtec, how does that increase technological autonomy and resilience?” asked Els Torreele, a visiting fellow at the Institute for Innovation and Public Purpose at University College London, in a tweet. https://twitter.com/ElsTorreele/status/1493974017967067142 Image Credits: BioNTech, BioNTech , @StellenboschUni, BioNTech Press conference . Depression Remains Overlooked and Underfunded; Experts Call to Reduce Global Burden 16/02/2022 Raisa Santos Street scene in Metro Manila, Intramurous district, Philippines. 80-90% of those with depression are left untreated or undiagnosed in low- and middle-income countries. Homelessness is one adverse experience that may cause depression. With about half of people suffering from depression in high income countries untreated or undiagnosed, with this number rising to 80-90% in low- and middle-income countries, a Lancet and World Psychiatric Association Commission have called for a unified response against this global crisis to reduce the burden of depression. Depression is estimated to impact 5% of adults globally, with its onset most frequent in young people. COVID-19 has caused ‘mass trauma’ worldwide and has further worsened mental health for millions, creating additional challenges with isolation, bereavement, uncertainty, hardship, and limited access to healthcare. To combat the crisis, the Commission’s ‘Time for united action on depression’ calls for a concerted and collaborative front from all – government, healthcare providers, researchers, and people living with depression, to improve care and prevention, fill knowledge gaps, and increase awareness for one of the leading causes of avoidable suffering and premature death worldwide. “Depression is a global health crisis that demands responses at multiple levels,” said Commision Chair Professor Helen Herrman. “This Commission offers an important opportunity for united action to transform approaches to mental health care and prevention globally.” The report is authored by 25 experts across 11 countries, from experts in neuroscience to global health. It is advised by people with experience of depression. Myths surrounding depression fuel inaction Myths surrounding mental health have fueled inaction. While 70-80% of people who die by suicide in high income countries, and around half in LMIC, suffered from mental illness, with depression as the most common cause, myths surrounding this health condition have fueled global inaction towards depression. The myths include the misconception that depression is simply sadness, a sign of weakness, or restricted to certain cultural groups. Depression also has an under-recognized social and economic toll, with the loss in economic productivity linked to depression costing the global economy an estimated $1 trillion a year. “There is arguably no other health condition which is as common, as burdensome, as universal, or as treatable as depression, yet it receives little policy attention and resources”, said Commission Co-Chair Associate Professor Christian Kieling, of the Brazil-based Universidade Federal do Rio Grande do Sul. The Commission does stress that depression is distinctly a health condition that is characterized by persistence, as it inhibits daily functioning and may lead to long-term health consequences. Depression may also impact anyone, regardless of gender, background, social class, and age, though symptoms and signs of depression may vary among groups. Society and individual strategies proposed Mental health services for children and adolescents have been disrupted due to COVID-19. Solutions to reduce the global burden of depression need to prevent adverse experiences in childhood. Whole-of-society and individual level strategies have been proposed by the Commission to prevent depression, focusing on reduced exposure to adverse experiences in childhood, lifestyle factors, and other stressful events, including financial crisis or bereavement. “Prevention is the most neglected aspect of depression. This in part because most interventions are outside of the health sector”, said co-author Dr Lakshmi Vijayakumar from SNEHA, Suicide Prevention Centre and Voluntary Health Services of Chennai, India. Vijayakumar further noted how crucial these prevention efforts are. “In the face of the lifelong effects of adolescent depression, from difficulty in school and future relationships to risk of substance abuse, self-harm, and suicide, investing in depression prevention is excellent value for money. It is crucial that we put into practice evidence-based interventions that support parenting, reduce violence in the family, and bullying at school, as well promoting mental health at work and addressing loneliness in older adults.” Current classification of depression is ‘too simplistic’ The current classification that places people with symptoms of depression into just two categories – either they have clinical depression or not – remains too simplistic, says the Commission. Instead, the Commission supports a personalized, staged approach to depression care that tailors and recommends interventions to the individual and the severity of their condition. These treatments range from self-help to lifestyle changes to psychological therapies. “No two individuals share the exact life story and constitution, which ultimately leads to a unique experience of depression and different needs for help, support, and treatment”, explained Commission Co-Chair Professor Vikram Patel from US-based Harvard Medical School. In addition, the Commission also proposes collaborative care strategies that incorporate locally recruited, widely available non-specialists such as community health workers and lay counselors. Ultimately, they conclude that greater investment is needed on behalf of the government to reduce the damaging impact of poverty, gender inequity, and other social inequalities on mental health. Said Patel: “Tackling the climate emergency, the COVID-19 pandemic and other global and regional emergencies that exacerbate existing inequities and threats to health, including pursuit of the UN Sustainable Development Goals, must also be vital parts of efforts to prevent depression.” Image Credits: Wayne S. Grazio, Nenad Stojkovic/Flickr, WHO/NOOR/Sebastian Liste. US and Africa Plan to Harness PEPFAR Networks to Increase COVID Vaccine Uptake 15/02/2022 Kerry Cullinan US Secretary of State Antony Blinken CAPE TOWN – The US and Africa intend to use the well-established community networks supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) to improve the uptake of COVID-19 vaccines in Africa. The initaitive would build upon the infrastructure developed since PEPFAR entered as a major player on the African AIDS scene in 2003. In addition, USAID has launched an initiative called Global VAX to support the World Health Organization (WHO) target of vaccinating 70% of the world’s population by mid-year against COVID-19, and will soon be announcing priority countries in Africa. This is according to US State official Mary Beth Goodman, who briefed African journalists on Tuesday on the COVID-19 Global Action Meeting convened by US Secretary of State Antony Blinken on Monday. “We’re leveraging opportunities through things like PEPFAR, which has an extraordinary network across the African continent in combating HIV/AIDS and has a network of community workers and leaders who are helping to work with us to also talk about some of the importance of COVID,” said Goodman, who is Acting Coordinator for Global COVID-19 Response and Health Security at the US Department of State. “The same is true of our Presidential Malaria Initiative and other efforts that have long been in place on the continent. “We actually have launched through USAID and the Centre for Disease Control, a programme that we’re calling Global VAX,” added Goodman. “The effort behind Global Vax is all about the uptake issues. How do we turn vaccines into vaccinations? How do we connect the dots to make sure that we are getting these vaccines distributed in a way that allows more people to have the opportunity to take the vaccine and that allows some of these countries which are lagging to meet the 70% target?” Blinken’s six-point ‘GAP’ plan Ghanian health worker Evelyn Narkie Dowuona holds up her COVID-19 vaccination card. Blinken presented a six-point COVID-19 Prioritized Global Action Plan for Enhanced Engagement (GAP) to foreign ministers and senior leaders from countries and international organizations invited to his virtual meeting. “Together, we identified urgent gaps in response activities and aligned around specific roles to advance global efforts aimed at bringing this pandemic under control and strengthening readiness for future global health threats. We agreed that more political leadership is needed to save lives and end this pandemic cycle in 2022,” said Blinken in a statement issued late Monday. He identified the “six lines of the global effort to respond to acute pandemic needs” as: Getting Shots in Arms: coordinated efforts to improve vaccine readiness and logistics, in step with increased donations and procurement, toward the goal of at least 70% of the population fully vaccinated with quality, safe, and effective vaccines by September 2022. Bolstering Supply Chain Resilience: mechanisms to facilitate sufficient and steady supplies of critical products and materials to break this cycle of the COVID-19 pandemic, including establishing mechanisms to identify and remove medical supply chain bottlenecks. Addressing Information Gaps: global efforts to enhance vaccine confidence and combat the spread of false information, enlisting regional champions and medical, civil society, young people, and faith leaders to use evidence-based, accurate, locally relevant messaging. Supporting Health Workers: protecting the health, safety, and wellbeing of frontline health workers, including the need to improve their training and numbers to effectively support the COVID-19 response. Ensuring Acute Non-Vaccine Interventions, including the provision of therapeutics, testing regimes, and oxygen where needed most. Strengthening Global Health Security Architecture to end the current pandemic and. secure future preparedness for health emergencies at the national, regional and global level. Blinken also announced a direct donation of 5 million doses of Johnson & Johnson’s COVID-19 vaccine to the African Vaccine Acquisition Trust (AVAT), the African Union’s vaccine procurement and distribution effort. The US has now donated more than 155 million doses to Africa and 435 million doses worldwide. Praise for Uganda vaccine effort Ugandan Health Minister Dr Jane Ruth Aceng (left) and French Ambassador to Uganda Jules-Armand Aniambossou with donated AstraZeneca COVID-19 vaccines. In his address to the GAP meeting, Blinken praised Uganda for its massive vaccination effort in November and December last year as an example of what is possible. “In early November, only 14% of all Ugandan adults had received their first dose of the vaccine,” said Blinken. “Then a major team effort commenced. The Ugandan government led a mass vaccination campaign, carried out by hundreds of health care workers,” he added, and “by late December, almost half of all adults in Uganda had received their first shot – from 14 to 47% in just six weeks”. Participants in the GAP meeting included Australia, Canada, Colombia, France, Germany, India, Indonesia, Italy, Japan, the Republic of Korea, New Zealand, Saudi Arabia, Senegal, South Africa,Spain, UK, the African Union/Africa Centres for Disease Control, the European Commission, and the WHO. They have all committed to coordinating parts of the six key areas identified. Meanwhile, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the meeting that “in some countries, high vaccine coverage, combined with the lower severity of Omicron, is driving a false narrative that the pandemic is over”. However, the low vaccine coverage and low testing rates in other countries “are creating the ideal conditions for new variants to emerge”, warned Tedros, adding that 116 countries are off track to vaccinate 70% of the population by the middle of this year. “We can bring the pandemic under control this year – but we are at increased risk of squandering that opportunity,” said Tedros, adding that “in many countries, the issues are not primarily a problem of absorptive capacity. We need to urgently support political leaders to accelerate the rollout of vaccines”. Image Credits: WHO, Health Journalist Network. Malnourished Afghan Children in The Grasp of Measles Outbreak 15/02/2022 Shadi Khan A mother and her child in the Haji camp for internally displaced people in Kandahar, Afghanistan. More and more children are losing their lives to a measles outbreak in Afghanistan as the country struggles with a humanitarian crisis under the US sanctions on the country’s Taliban regime. Following the Taliban’s takeover of Afghanistan, the US Department of the Treasury froze Afghanistan Central Bank’s reserves, mostly held in US banks, as the Taliban has been on its “specially designated global terrorist group” since 2002, and any support for the group is illegal. The measles outbreak has hit the malnourished children hard in some of the already marginalized and poor communities in Paktika, Ghor, Badakhshan and other provinces of Afghanistan. The World Health Organization (WHO) last week confirmed that the number of cases and deaths increased by 18% in the week of 24 January, and 40% in the week of 31 January. Health Policy Watch reported last week that WHO Director-General Dr Tedros Adhanom Ghebreyesus met with the Taliban in Geneva to discuss Afghanistan’s health challenges. Struggle for meals in the pandemic According to the global health body, as many as 35,319 suspected cases of measles and 156 deaths have been reported in Afghanistan between 1 January 2021 and 29 January 2022. Of these, 3,221 cases were laboratory confirmed while 91% of these cases and 97% of these deaths were in children under five years of age. The WHO says that the rise in measles cases is especially concerning because of the extremely high levels of malnutrition in Afghanistan. This weakens immunity, making people more vulnerable to illness and death from diseases like measles – especially children. Local civil society activist in Paktika, Abdul Bari, mentioned that with the fall of the previous government, thousands of people lost their jobs and could not support families for months now that ultimately led to malnourishment and spread of the diseases. “Many families who were doing relatively well in the past now find them among the so many very poor in the society that struggle to feed one or two meals in Paktika”, he said. Mirwais Hospital, Kandahar – The hunger and poverty is more visible than ever in Afghanistan especially on the faces of the youngest victims of the crisis. Hospitals and healthcare facilities are filling up with babies and children suffering from malnutrition pic.twitter.com/J8B6VyEocS — Yalda Hakim (@SkyYaldaHakim) November 29, 2021 Authorities in Badakhshan province told the Health Policy Watch about an outbreak of measles worst affecting the remote Kuf Ab and Kohistan districts of the province where poverty is widespread. “The measles outbreak has been spreading in the province for the past two months and has spread to ten districts, including the capital Faiz Abad”, he said, adding that so far no organization or health institution has come to their aid and many children have died due to the disease in Kuf Ab and Kohistan districts. Equally remote and poor, Ghor province in the central highlands of Afghanistan is the second flashpoint for the measles outbreak according to the Afghan authorities. The provincial health department head, Mohammad Nazim, told the Health Policy Watch that more than a thousand children have been referred to the province’s central hospital recently and 21 of whom have died because of measles. “The reason for the spread of measles is the non-implementation of the vaccination program firstly due to the coronavirus pandemic and then the security concerns and lack of funds”, he said. Crumbling Healthcare System In December 2021, a measles outbreak response immunisation campaign was carried out with the support of the WHO in some of the most affected provinces, reaching 1.5 million children. Battling for survival, Afghanistan’s fragile health system has been on the edge for months in the wake of the COVID-19 pandemic, the Taliban takeover of power and the subsequent US freezing of Afghanistan’s state reserves. In Ghor, the regional public hospital sources said the doctors and support staff is so overstretched and under-paid that it can collapse any moment in the wake of mounting cases of COVID-19 and now the measles outbreak. Kabul-based paediatrician Dr Zar Wali told the Health Policy Watch that malnutrition among children was severely compromising their immune system. “On a daily basis I am receiving dozens of child patients from the city (Kabul) as well as the nearby provinces, and there is this clear pattern of malnourishment in almost all, which makes them susceptible to all sorts of diseases”. This was echoed by the UN Children Fund (UNICEF) last week when it warned that as the humanitarian crisis deepens in Afghanistan, hospitals were receiving so many cases each day of children suffering complications associated with severe acute malnutrition. After relatively low transmission in 2019 and 2020, new infection cases have been increasing in all provinces since the end of July 2021, with the highest weekly toll observed so far occurring over the last four weeks. The WHO has warned that although the number of deaths is relatively low, the rapid rise in cases in January 2022 suggests that the number of deaths due to measles is likely to increase sharply in the coming weeks. Being endemic in Afghanistan, more than 25,000 children get killed by the measles virus annually, according to the Ministry of Public Health, and many more struggle with its impacts. The WHO has expressed willingness to prepare a plan for a larger measles outbreak response immunisation campaign, which will start in May (or earlier, if possible), aiming to reach more than 3 million children in Afghanistan. Image Credits: © UNICEF Afghanistan. African Medicines Agency Host Country Could be Selected by July 15/02/2022 Kerry Cullinan Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD The African Union could decide on the host country for the African Medicines Agency (AMA) as early as July, while the agency’s director-general should be appointed by the end of the year. This is according to Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD, the African Union’s development agency. The AU Assembly had recently decided to “do an assessment of the countries that have offered to host the AMA headquarters”, she told a workshop convened by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on Monday ahead of the EU-AU Summit which starts in Brussels on Thursday. “The AU Commission and AUDA-NEPAD are working together, and the teams are set to go out in the first week of March,” said Ndomondo-Sigonda, adding that the country visits may take two months to complete. “Once they are done, then the assessment report will be presented before the first meeting of the Conference of the State Parties that is planned to be held sometime in May,” she added. Whatever decision is made by this body would have to go to the AU Assembly during its meeting in in June or July, “so by July we will know which countries actually hosting the headquarters for the African Medicines Agency,” she added. The Assembly comprises of all Member State Heads of State and Government is the AU’s supreme policy and decision-making organ. Director-General may be appointed by year-end As far as the appointment of the head of the AMA – its director general – is concerned, this would take a little longer. First, the Conference of the State Parties would have to consider the terms of reference for the position at its May meeting, and advertisements will only go out after that. “By the time we get to know who has been appointed as the director-general, it will probably be quarter three or quarter four this year,” she said. She added that AMA was being established as “a specialised agency of the African Union with its autonomy in terms of financial and human resources, so it’s going to be operating differently from what you see with Africa Centres for Disease Control at the moment”. Meanwhile, UNAIDS Executive Director Winnie Byanyima welcomed the imminent establishment of the AMA. “Since the very beginning of the COVID crisis, the multilateral response may have failed us but African leadership has been remarkable,” said Byanyima at a workshop on Monday. “The newly created African Medicines Agency will harmonise medicine regulations, and negotiate joint purchasing and the manufacture of our own medicines.” European and African Pharma Sector Want Permanent Platform to Support African Development 14/02/2022 Kerry Cullinan A staff member at Afrigen, the mRNA hub in South Africa, prepares part of the vaccine. The major players in the European and African pharmaceutical sectors have called on the European Union (EU) and the African Union (AU) to support the creation of a permanent “business platform” to foster the pharma industry’s development in Africa. This emerged at a workshop Monday hosted by the the European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) along with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and other European-based pharma associations. The workshop was part of the European African Business Forum (EABF) taking place ahead of, and along with, the European Union–African Union Summit, which begins Thursday in Brussels. The business platform should support the development of EU and AU policies conducive to trade and “sustainable financing mechanisms models with access to low-interest capital” and appropriate incentives to encourage local, regional and international private sector investment, according to IFPMA Assistant Director-General Greg Perry, speaking at the Monday EABF session leading up to the Summit. Businesses also want a “stable business environment that respects business ethics and incentivises local innovation and entrepreneurship, including through intellectual property, ensure development and retention of local skilled workforces”, said Perry, reading from a joint statement by the EABF’s Healthcare Working Group, which also includes the European Federation of Pharmaceutical Manufacturers and Associations (EPFIA) and Vaccines Europe. The pharmaceutical sector also wants voluntary and mutually agreed upon technology transfers and joint ventures; timely product registration, harmonisation of regulation particularly through the African Medicines Agency, and the implementation of the African Continental Free Trade Area to eliminate non-trade barriers and foster international supply chain security. “We believe that creating this platform with the support of the EU and the AU, we could facilitate African and European partnerships, support existing continental and regulatory initiatives and create a win-win for both Africa and Europe,” said Perry. Where is the money that was promised? Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee Emmanuel Mujuru, representing the Federation of African Pharmaceutical Manufacturers (FAPMA), said that the African pharmaceutical industry was struggling to access affordable financing. “This financing has to both long-term in nature and have affordable interest rates, either in the form of loans or equity participation in already established African pharma management companies,” said Mujuru. He added that there was a significant opportunity for European investors as between 70 and 90% of essential medicines consumed in Africa were imported and that the pharmaceutical sector was growing at over 10% per annum, second only to Asia. Merck’s Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee, said that while setting up fill and finish operations “is easy to implement in two years”, he had tried to do so in three different African countries but “local private sector investors have never been able to get access to any finance”. “Why? The International Finance Corporation has announced $4 billion for the local vaccine manufacturing and the European Commission has announced one billion Euros,” asked Bendhaou “We also have to invest in the health system capacity because otherwise, you can have a nice factory in in South Africa, a beautiful factory in Egypt, producing hundreds of millions of doses but if you don’t have a health system in place for the uptake and to absorb this capacity,” he added. What about Gavi subsidies? Biovac CEO Patrick Tippoo Meanwhile, Patrick Tippoo, CEO of the South African company, Biovac and part of the African Vaccine Manufacturing Initiative (AVMI) leadership, said that much of Africa’s vaccine supply “comes in a subsidised form, partially or completely by Gavi through UNICEF”. “We know that Gavi drives prices down to make vaccines more affordable so more vaccines can be purchased and therefore distributed,” said Tippoo “We have a current situation where about 40 of the 54 countries depend on this mechanism. And therefore the market in Africa is actually in Copenhagen, as some people say. “This is a structural thing that will have to be addressed because, in order to stimulate and incentivize technology transfers, investment in skills, development, regulatory capacity building – and all the things that we repeat ad nauseum – there needs to be an assurance that there’s going to be a market when all of this is built,” he stressed. Tippoo added that African governments and other stakeholders had to understand that a “resilience premium” would need to be paid to ensure that pharmaceutical manufacturing capability is built in Africa. “There is no way in which vaccines coming out of Africa in the next five or 10 years can compete on a cost of goods perspective, with Indian manufacturer factories, or even multinationals because they’ve monetised the investment over time, and they have economies of scale,” he added. Diversification a ‘win-win’ for Africa, Europe and globally However, other participants pointed out that over the long-term, diversification of sources for pharma procurement is going to be a win win, given the comparatively limited number of suppliers, for some key global health products. Interruptions to key medical supply chains were particularly evident during the early stages of the COVID pandemic, exposing their fragility, even for more affluent countries. Sibilia Quilici, Executive Director, Vaccines Europe, pointed out that from the European perspective, too, it would be beneficial to reduce dependence on what is now a comparatively small number of suppliers, mainly from India and China, and integrate Africa’s supply chains with global ones: “In the context of this discussion on improving manufacturing capacities in Africa, also for APIs [active pharmaceutical ingredients] it is good to be aware that the EU, the largest API importer in the world is looking for supply chain diversification for products where dependence on a small number of suppliers from India and China is a concern. “This could be a win-win for Africa, EU, local and global industry”. Image Credits: Rodger Bosch for MPP/WHO, WHO . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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European Investment Bank Pledges €500 million to WHO-EU Partnership for Stronger African Health Systems 17/02/2022 Editorial team WHO DG Tedros Adhanom Ghebreyesus and EIB President Werner Hoyer. The European Investment Bank said Thursday that it would commit €500 million to improving African health systems, as part of a new initiative with the World Health Organization and the European Union. The joint EIB-WHO-EU statement coincided with the start of an EU-African Union Summit, which is set to talk about how to improve health systems in Africa, as well as stepping up vaccine production. While there have been some recent, big strides to jump-start more African vaccine manufacturing and related R&D, including in the WHO-supported South African mRNA hub and a BioNTech modular vaccine manufacturing initiative, announced only yesterday (hyperlink please to those two stories), much less attention has been focused on health systems, which are the backbone for service delivery. And recent data suggests that African health systems, like others worldwide, continue to suffer setbacks in delivery of other routine services, due to the pandemic. Two Years Into COVID Pandemic, 92 % Of Countries Still Face Significant Health Service Disruptions – Health Policy Watch https://t.co/GPXrhKpLpT via @HealthPolicyW pic.twitter.com/crGfmwzxQM — African Health Observatory Platform (@AHOPlatform) February 17, 2022 That, along with being chronically underfinanced – with most countries far from the Abuja goal of investing 15% of GDP in health services. Only two countries – Rwanda and South Africa – had reached the 15% target in 2011, while seven had actually reduced their health budgets proportionate to their national budgets. The situation had deteriorated further in 2016, with 19 African countries spending less on health as a percentage of their public spending than in the early 2000s. According to the 2016 WHO report, countries with high per capita income such as Algeria, Botswana, South Africa, and Seychelles, do not systematically spend more of their budgets on health, while lower income countries such as Ethiopia, Gambia, and Malawi – have in fact surpassed the 15% goal. The new initiative aims to address both the pandemic-related and more systematic issues, said a WHO press statement on the EIB investment. It noted that the investments would be focused on “restoring, expanding and sustaining access to essential health services and increasing financial risk protection; access to vaccines, medicines, diagnostics, devices and other health products; scaling innovative primary health care service delivery models and investing in a health workforce to deliver effective quality care. “The shared goals of the partnership will achieved by applying a country-led and country-driven approach, identifying gaps in national health systems, designing strategies for interventions and their corresponding investments plans, investing in health system projects and programmes, convening capital providers, supporting implementation and monitoring impact,” said WHO. EIB President Werner Hoyer, said that the goal of the initiative is to mobilize €1 billion of new investment “to strengthen public health across Africa.” Said WHO Director General Dr Tedros Adhanom Ghebreyesus: “The COVID-19 pandemic is a powerful demonstration that when health is at risk, everything is at risk. Investing in health across Africa is therefore essential not just to promote and protect health, but also as a foundation for lifting people out of poverty and driving inclusive economic growth.” Image Credits: EIB/Twitter. BioNTech To Ship Modular mRNA Vaccine Facilities in Containers to African Countries to Jump-start Production 16/02/2022 Elaine Ruth Fletcher Display in Marburg Germany of the BioNtainer container that will be shipped to Africa to jump-start mRNA vaccine manufacturing on the continent. The German-based BioNTech, which co-developed with Pfizer an mRNA COVID vaccine, said on Wednesday that it will set up modular “turnkey” mRNA vaccine facilities to produce the vaccine in Rwanda and Senegal in 2022 – with a fill-and-finish collaboration in Ghana as well. South Africa, which is the new hub for the WHO-supported mRNA vaccine R&D and manufacturing hub focusing on open-access products- may also join the initiative later, said the company in a press release. Speaking at a press briefing Wednesday morning, which included the presidents of Rwanda, Ghana and Senegal, as well as WHO and Africa CDC, BioNTech CEO Ugur Sahin, described the new cutting-edge BioNTainer initiative for vaccine production as – following “the most elementary principle of reducing complexity by copying the manufacturing units having modular action unit and by copying the process and transferring it to another place. “But this is not about innovation alone, it it is about collaboration,” Sahin added, “for example, implementation of the manufacturing side, about regulation, about supply of vaccines… no one can do it alone, we have to do it together,” Sahin said. He said that the first containers would be delivered to Africa in mid-2022 “and we want to start with the manufacturing of the first vaccine batches in the first months after we deliver the containers.” The new production facilities are designed to produce not only COVID-19 vaccines, but other “future vaccines” in the planning for malaria, tuberculosis and HIV: “If these vaccines are successful and approved they will be produced in Africa, and these containers can be useful.” Welcomed by African leaders Left to right: BioNTech CMO Özlem Türeci and CEO Ugur Sahin; with African heads of state, Nana Akufo-Addo (Ghana); Macky Sall (Senegal) and Paul Kagame (Rwanda) and WHO’s Director General Tedros Adhanom Ghebreyesus; and kNUP’s Holm Keller at BioNtech briefing on new BioNTainer plug-and-play facility. The initiative was roundly welcomed by the heads of Ghana, Senegal, Rwanda – all of whom were present at the briefing – as well as the heads of WHO and Africa CDC. “Today is a historic day. Today, we are putting an end to the vaccine injustice that has occurred during the pandemic, where Africa was left by the wayside,” said Senegal’s President Macky Sall, who opened Wednesday’s public briefing in Marburg, Germany, where the three African heads of state had been meeting with BioNTech officials over the past several days on the BioNtainer concept. “Thanks to the innovation of BioNtech, with the BioNtainer, we are going to transfer the technology to Africa, to produce the API for the mRNA vaccines, along with the fill-and-finish. And we can thus be able to produce COVID-19 vaccines, as well as having the potential to produce vaccines for other diseases,” he said. “We commend this cooperation between Europe and Africa, between BioNTech and African countries, as well as foundations and development banks that are providing the financial backing, so that we can very soon produce these vaccines on our continent.” Africa CDC head John Nkengasong also welcomes the new BioNTech initiative Meanwhile, Africa CDC head John Nkengasong praised BioNTech for “showing leadership” on the innovative ‘turn key’ production facilities, saying, “You are teaching us how to fish, and not giving us a fish….The African Union and Africa CDC will continue to work with you in this journey.” And Ghana’s President Nana Akufo-Addo, said his country would be dedicating it’s National Vaccine Institute to support the initiative to develop “partnerships for vaccine deployment and manufacturing in areas of funding, clinical trials and fill-and-finish capacity.” Ghana will set up a fill-and-finish facility soon, he said, in order to perform the last step of the BioNTech process – to be completed outside of the modular vaccine factory containers. BioNTainer concept explained at BioNTech press briefing on Wednesday 16 February 2022 WHO affirms initiative has African “ownership” Meanwhile, WHO’s Director General Dr Tedros Adhanom Ghebreyesus expressed support for the new project – despite the criticism that had been levelled at it in a recent BMJ investigation, which had portrayed it as a potential competition to the new WHO-supported mRNA vaccine manufacturing hub set up in South Africa, which aims to promote an open-license approach to vaccine manufacturing – in contrast to collaborations built around the bilateral licensing of patented products, such as Pfizer’s. Tedros visited the South African mRNA hub, which has replicated a version of the Moderna mRNA vaccine, just last Friday. “Many colleagues have been discouraged about the success of this project,” said Tedros, in an oblique reference to the earlier criticism levelled at the notion of shipping ready-made vaccine facilities in containers to Africa. He underlined that the endorsement by African national and African Union leaders shows that the BioNTech initiative is viable: “Their presence shows political commitment, their presence shows ownership. And when projects are owned and political commitment is provided from the leaders, projects normally succeed…. failure is not an option for this project, from what I observed,” said Tedros. .@DrTedros @WHO in oblique reference to prior @BMJ criticism of the initiative says "many colleagues have been discouraged about the success of this project….one thing that convinces me is that the presence of these leaders – their presence shows ownership." https://t.co/0GvaqaRSJ9 pic.twitter.com/lZFEBRQmiD — Health Policy Watch – Global Health News Reporting (@HealthPolicyW) February 16, 2022 ‘Miniaturized’ and standardized mRNA production BioNTech COO Sierk Poetting at a meeting briefing on the BioNTainer initiative. The new manufacturing systems effectively takes advantage of the comparatively small size of mRNA vaccines inputs, and their unique production technology, to “miniaturize” and standardise the vaccine production process, said BioNTech’s BioNTech Chief Operating Office (COO) Sierk Poetting at a press conference later Wednesday afternoon. He said innovation had been developed at Pfizer’s Marburg, Germany facility, which is Pfizer’s largest manufacturing operation, and would also now serve as global quality control center for the plug-and-play systems sent to Africa. The modular facilities would be built of ISO-standard 40 foot containers “We can put them on trucks, boats, or planes and ship those manufacturing BioNtainers to the world, to the target locations,” said Poetting. “The power of the mRNA drug class is that it is versatile and can be prepared rapidly,” said Sahin, noting that the facilities would also serve the production of future mRNA vaccines under development by Pfizer for other diseases. Turnkey facilities will be pre-approved as GMP complaint in Germany Turnkey facilities will be pre-approved as GMP compliant in Germany and then shipped to Africa – BioNTech CEO Sahin Sahin said that the modular facilities could be pre-approved as GMP compliant at Pfizer’s Marburg, Germany plant where the turnkey solution was developed – and which will supervise the initiative: “The turnkey package includes the modular production unit, GMP compliance set up, and personnel training to ensure that we can transfer the technology,” he explained. “The elements of the container-based, plug-and-play approach was modular design.. by having this standardized design, we can ensure that the facility, once approved somewhere, can be transferred to another place, and with a little additional work, the process can be GMP [compliant]. That means that the facility would be built and pre-approved to meet European manufacturing requirements, and once transferred to Africa, could be quickly approved by national regulatory processes as well, ensuring a quick start to manufacturing, said Sahin. Turnkey facility includes “plug and play” production meeting GMP standards, said BioNTech’s Ugur Sahin, at the press conference. There would be six containers – six for producing the active pharmaceutical ingredient and six more for producing the final drug product. They would be set up in an air-conditioned factory hall, equipped with refrigeration and other basic infrastructure, Poetting explained. ‘Fill and finish’ would take place at other sites in collaboration with national and local African partners. Sahin said that the first facility would be set up in mid-2022, with the aim of being fully operational by the end of the year. The facilities could produce up to 50 million doses a year – although actual production would vary by demand. Products would be sold at cost in African Union countries. “The goal of the BioNtainer is to reduce the cost and the speed of the development of manufacturing facilities, and provide a solution which is suitable for the needs of people living in this region,” said Sahin. Did BioNTech’s kENUP consultants try to undermine South Africa’s mRNA vaccine hub? Tedros visits Stellenbosch University’s Biomedical Research Institute & Centre for Epidemic Response & Innovation on 11 February, 2022, part of South Africa’s WHO co-sponsored mRNA vaccine hub. Asked why BioNTech had decided not to share Pfizer’s vaccine technology with the new WHO-supported mRNA vaccine tech transfer hub in South Africa, Poetting said that the company would collaborate by taking staff that are trained there to help manage the new BioNTech manufacturing facilities – which would initially be staffed by Pfizer’s European teams. “We will onboard the local teams and do the knowledge transfer and the production together,” Poetting said, adding, “we are actually collaborating with the transfer hubs. We will work together with the transfer hubs on staffing the units, on training the units, and for distribution of the units” he said. But for actual production processes, the BioNTainer facilities could be set up and become operational sooner, he asserted. Meanwhile, Sahin refused to comment on the recent allegations, published in The BMJ that the kENUP Foundation, a BioNTech consultancy that helped develop the BioNTainer initiative, had actually sought to undermine the South African tech transfer hub – which along with training African scientists and technicians also aims to develop open-access versions of mRNA vaccines. Holm Keller of the kENUP Foundation, moderating BioNTech’s launch of its new “BioNTainer’ initiative on Wednesday; kENUP is also alleged to have sought the “termination” of the WHO-supported South African mRNA hub. According to The BMJ, kENUP had sent a mission report to the South African government after a visit last August, saying that the hub’s project “of copying the manufacturing process of Moderna’s COVID-19 vaccine should be terminated immediately. This is to prevent damage to Afrigen, BioVac, and Moderna . . . “Provided that the release from patent cover will be granted by Moderna only during the pandemic, the sustainability outlook for this project of the WHO Vaccine Technology Transfer Hub is not favourable,” stated the report, obtained by The BMJ. Scientists at Afrigen have since said that they managed to replicate the Moderna mRNA vaccine – without assistance from the US-based pharma firm, which has nonetheless promised not to enforce its patents on its COVID-19 vaccine during the pandemic. “We can’t comment on behalf of kENUP, and also not on behalf of WHO,” Sahin said. “We can just state that at the moment several projects with the same goal are underway, and we welcome any projects with the same goals. What is important at the beginning, of course, to understand the overall framework, and what are the specific aspects of the individual partners, and identify ways to collaborate.” New projects on African continent – a turning point… In fact, the silver lining in the vaccine inequalities in Africa, sharply highlighted by the COVID pandemic, is the surge of new vaccine manufacturing initiatives, said Greg Perry, Assistant Director of the International Federation of Pharmaceutical Manufacturers and Associations, in a comment to Health Policy Watch. “What is significant is how much is happening on the African continent, and much from private sector, from J&J ‘s agreement with Aspen Pharmacare, to the BioNTech- Biovac partnership on manufacturing and distribution activities, to the various BioNTech actions announced today,” he said. He made his comment shortly after the new head of Tanzania, formerly one of the continent’s most COVID vaccine-hestitant countries, said that it, too, would like to set up a vaccine manufacturing plant to tackle COVD and other diseases. New President, Samia Suluhu Hassan described her plans at a meeting with European Union President Charles Michel in Brussels, BBC reported. Meanwhile, in Nigeria, a vigorous debate over the creation of a national vaccine manufacturing initiative is also underway. “We should be open to all these initiatives,” Perry said. “But what is key is that are long term, sustainable, and based on voluntary partnership. Moreover they will all face the same challenges, needs for skills and regulatory support; long- term financing and demand stability. It’s these real challenges and solutions we are talking about in Brussels this week at the European-African Business Forum,” he said, referring to a pharma meeting ongoing this week ahead of European Union-African Union summit. Ont the other side of the fence, pharma critics that have looked at the South African mRNA hub, as the seedling from which new patent-free modes of vaccines manufacture might take root and flourish on the continent, were not so enthusiastic about the new BioNTech initiative. “When local production in Africa is done under monopoly control of Pfizer/BioNtec, how does that increase technological autonomy and resilience?” asked Els Torreele, a visiting fellow at the Institute for Innovation and Public Purpose at University College London, in a tweet. https://twitter.com/ElsTorreele/status/1493974017967067142 Image Credits: BioNTech, BioNTech , @StellenboschUni, BioNTech Press conference . Depression Remains Overlooked and Underfunded; Experts Call to Reduce Global Burden 16/02/2022 Raisa Santos Street scene in Metro Manila, Intramurous district, Philippines. 80-90% of those with depression are left untreated or undiagnosed in low- and middle-income countries. Homelessness is one adverse experience that may cause depression. With about half of people suffering from depression in high income countries untreated or undiagnosed, with this number rising to 80-90% in low- and middle-income countries, a Lancet and World Psychiatric Association Commission have called for a unified response against this global crisis to reduce the burden of depression. Depression is estimated to impact 5% of adults globally, with its onset most frequent in young people. COVID-19 has caused ‘mass trauma’ worldwide and has further worsened mental health for millions, creating additional challenges with isolation, bereavement, uncertainty, hardship, and limited access to healthcare. To combat the crisis, the Commission’s ‘Time for united action on depression’ calls for a concerted and collaborative front from all – government, healthcare providers, researchers, and people living with depression, to improve care and prevention, fill knowledge gaps, and increase awareness for one of the leading causes of avoidable suffering and premature death worldwide. “Depression is a global health crisis that demands responses at multiple levels,” said Commision Chair Professor Helen Herrman. “This Commission offers an important opportunity for united action to transform approaches to mental health care and prevention globally.” The report is authored by 25 experts across 11 countries, from experts in neuroscience to global health. It is advised by people with experience of depression. Myths surrounding depression fuel inaction Myths surrounding mental health have fueled inaction. While 70-80% of people who die by suicide in high income countries, and around half in LMIC, suffered from mental illness, with depression as the most common cause, myths surrounding this health condition have fueled global inaction towards depression. The myths include the misconception that depression is simply sadness, a sign of weakness, or restricted to certain cultural groups. Depression also has an under-recognized social and economic toll, with the loss in economic productivity linked to depression costing the global economy an estimated $1 trillion a year. “There is arguably no other health condition which is as common, as burdensome, as universal, or as treatable as depression, yet it receives little policy attention and resources”, said Commission Co-Chair Associate Professor Christian Kieling, of the Brazil-based Universidade Federal do Rio Grande do Sul. The Commission does stress that depression is distinctly a health condition that is characterized by persistence, as it inhibits daily functioning and may lead to long-term health consequences. Depression may also impact anyone, regardless of gender, background, social class, and age, though symptoms and signs of depression may vary among groups. Society and individual strategies proposed Mental health services for children and adolescents have been disrupted due to COVID-19. Solutions to reduce the global burden of depression need to prevent adverse experiences in childhood. Whole-of-society and individual level strategies have been proposed by the Commission to prevent depression, focusing on reduced exposure to adverse experiences in childhood, lifestyle factors, and other stressful events, including financial crisis or bereavement. “Prevention is the most neglected aspect of depression. This in part because most interventions are outside of the health sector”, said co-author Dr Lakshmi Vijayakumar from SNEHA, Suicide Prevention Centre and Voluntary Health Services of Chennai, India. Vijayakumar further noted how crucial these prevention efforts are. “In the face of the lifelong effects of adolescent depression, from difficulty in school and future relationships to risk of substance abuse, self-harm, and suicide, investing in depression prevention is excellent value for money. It is crucial that we put into practice evidence-based interventions that support parenting, reduce violence in the family, and bullying at school, as well promoting mental health at work and addressing loneliness in older adults.” Current classification of depression is ‘too simplistic’ The current classification that places people with symptoms of depression into just two categories – either they have clinical depression or not – remains too simplistic, says the Commission. Instead, the Commission supports a personalized, staged approach to depression care that tailors and recommends interventions to the individual and the severity of their condition. These treatments range from self-help to lifestyle changes to psychological therapies. “No two individuals share the exact life story and constitution, which ultimately leads to a unique experience of depression and different needs for help, support, and treatment”, explained Commission Co-Chair Professor Vikram Patel from US-based Harvard Medical School. In addition, the Commission also proposes collaborative care strategies that incorporate locally recruited, widely available non-specialists such as community health workers and lay counselors. Ultimately, they conclude that greater investment is needed on behalf of the government to reduce the damaging impact of poverty, gender inequity, and other social inequalities on mental health. Said Patel: “Tackling the climate emergency, the COVID-19 pandemic and other global and regional emergencies that exacerbate existing inequities and threats to health, including pursuit of the UN Sustainable Development Goals, must also be vital parts of efforts to prevent depression.” Image Credits: Wayne S. Grazio, Nenad Stojkovic/Flickr, WHO/NOOR/Sebastian Liste. US and Africa Plan to Harness PEPFAR Networks to Increase COVID Vaccine Uptake 15/02/2022 Kerry Cullinan US Secretary of State Antony Blinken CAPE TOWN – The US and Africa intend to use the well-established community networks supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) to improve the uptake of COVID-19 vaccines in Africa. The initaitive would build upon the infrastructure developed since PEPFAR entered as a major player on the African AIDS scene in 2003. In addition, USAID has launched an initiative called Global VAX to support the World Health Organization (WHO) target of vaccinating 70% of the world’s population by mid-year against COVID-19, and will soon be announcing priority countries in Africa. This is according to US State official Mary Beth Goodman, who briefed African journalists on Tuesday on the COVID-19 Global Action Meeting convened by US Secretary of State Antony Blinken on Monday. “We’re leveraging opportunities through things like PEPFAR, which has an extraordinary network across the African continent in combating HIV/AIDS and has a network of community workers and leaders who are helping to work with us to also talk about some of the importance of COVID,” said Goodman, who is Acting Coordinator for Global COVID-19 Response and Health Security at the US Department of State. “The same is true of our Presidential Malaria Initiative and other efforts that have long been in place on the continent. “We actually have launched through USAID and the Centre for Disease Control, a programme that we’re calling Global VAX,” added Goodman. “The effort behind Global Vax is all about the uptake issues. How do we turn vaccines into vaccinations? How do we connect the dots to make sure that we are getting these vaccines distributed in a way that allows more people to have the opportunity to take the vaccine and that allows some of these countries which are lagging to meet the 70% target?” Blinken’s six-point ‘GAP’ plan Ghanian health worker Evelyn Narkie Dowuona holds up her COVID-19 vaccination card. Blinken presented a six-point COVID-19 Prioritized Global Action Plan for Enhanced Engagement (GAP) to foreign ministers and senior leaders from countries and international organizations invited to his virtual meeting. “Together, we identified urgent gaps in response activities and aligned around specific roles to advance global efforts aimed at bringing this pandemic under control and strengthening readiness for future global health threats. We agreed that more political leadership is needed to save lives and end this pandemic cycle in 2022,” said Blinken in a statement issued late Monday. He identified the “six lines of the global effort to respond to acute pandemic needs” as: Getting Shots in Arms: coordinated efforts to improve vaccine readiness and logistics, in step with increased donations and procurement, toward the goal of at least 70% of the population fully vaccinated with quality, safe, and effective vaccines by September 2022. Bolstering Supply Chain Resilience: mechanisms to facilitate sufficient and steady supplies of critical products and materials to break this cycle of the COVID-19 pandemic, including establishing mechanisms to identify and remove medical supply chain bottlenecks. Addressing Information Gaps: global efforts to enhance vaccine confidence and combat the spread of false information, enlisting regional champions and medical, civil society, young people, and faith leaders to use evidence-based, accurate, locally relevant messaging. Supporting Health Workers: protecting the health, safety, and wellbeing of frontline health workers, including the need to improve their training and numbers to effectively support the COVID-19 response. Ensuring Acute Non-Vaccine Interventions, including the provision of therapeutics, testing regimes, and oxygen where needed most. Strengthening Global Health Security Architecture to end the current pandemic and. secure future preparedness for health emergencies at the national, regional and global level. Blinken also announced a direct donation of 5 million doses of Johnson & Johnson’s COVID-19 vaccine to the African Vaccine Acquisition Trust (AVAT), the African Union’s vaccine procurement and distribution effort. The US has now donated more than 155 million doses to Africa and 435 million doses worldwide. Praise for Uganda vaccine effort Ugandan Health Minister Dr Jane Ruth Aceng (left) and French Ambassador to Uganda Jules-Armand Aniambossou with donated AstraZeneca COVID-19 vaccines. In his address to the GAP meeting, Blinken praised Uganda for its massive vaccination effort in November and December last year as an example of what is possible. “In early November, only 14% of all Ugandan adults had received their first dose of the vaccine,” said Blinken. “Then a major team effort commenced. The Ugandan government led a mass vaccination campaign, carried out by hundreds of health care workers,” he added, and “by late December, almost half of all adults in Uganda had received their first shot – from 14 to 47% in just six weeks”. Participants in the GAP meeting included Australia, Canada, Colombia, France, Germany, India, Indonesia, Italy, Japan, the Republic of Korea, New Zealand, Saudi Arabia, Senegal, South Africa,Spain, UK, the African Union/Africa Centres for Disease Control, the European Commission, and the WHO. They have all committed to coordinating parts of the six key areas identified. Meanwhile, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the meeting that “in some countries, high vaccine coverage, combined with the lower severity of Omicron, is driving a false narrative that the pandemic is over”. However, the low vaccine coverage and low testing rates in other countries “are creating the ideal conditions for new variants to emerge”, warned Tedros, adding that 116 countries are off track to vaccinate 70% of the population by the middle of this year. “We can bring the pandemic under control this year – but we are at increased risk of squandering that opportunity,” said Tedros, adding that “in many countries, the issues are not primarily a problem of absorptive capacity. We need to urgently support political leaders to accelerate the rollout of vaccines”. Image Credits: WHO, Health Journalist Network. Malnourished Afghan Children in The Grasp of Measles Outbreak 15/02/2022 Shadi Khan A mother and her child in the Haji camp for internally displaced people in Kandahar, Afghanistan. More and more children are losing their lives to a measles outbreak in Afghanistan as the country struggles with a humanitarian crisis under the US sanctions on the country’s Taliban regime. Following the Taliban’s takeover of Afghanistan, the US Department of the Treasury froze Afghanistan Central Bank’s reserves, mostly held in US banks, as the Taliban has been on its “specially designated global terrorist group” since 2002, and any support for the group is illegal. The measles outbreak has hit the malnourished children hard in some of the already marginalized and poor communities in Paktika, Ghor, Badakhshan and other provinces of Afghanistan. The World Health Organization (WHO) last week confirmed that the number of cases and deaths increased by 18% in the week of 24 January, and 40% in the week of 31 January. Health Policy Watch reported last week that WHO Director-General Dr Tedros Adhanom Ghebreyesus met with the Taliban in Geneva to discuss Afghanistan’s health challenges. Struggle for meals in the pandemic According to the global health body, as many as 35,319 suspected cases of measles and 156 deaths have been reported in Afghanistan between 1 January 2021 and 29 January 2022. Of these, 3,221 cases were laboratory confirmed while 91% of these cases and 97% of these deaths were in children under five years of age. The WHO says that the rise in measles cases is especially concerning because of the extremely high levels of malnutrition in Afghanistan. This weakens immunity, making people more vulnerable to illness and death from diseases like measles – especially children. Local civil society activist in Paktika, Abdul Bari, mentioned that with the fall of the previous government, thousands of people lost their jobs and could not support families for months now that ultimately led to malnourishment and spread of the diseases. “Many families who were doing relatively well in the past now find them among the so many very poor in the society that struggle to feed one or two meals in Paktika”, he said. Mirwais Hospital, Kandahar – The hunger and poverty is more visible than ever in Afghanistan especially on the faces of the youngest victims of the crisis. Hospitals and healthcare facilities are filling up with babies and children suffering from malnutrition pic.twitter.com/J8B6VyEocS — Yalda Hakim (@SkyYaldaHakim) November 29, 2021 Authorities in Badakhshan province told the Health Policy Watch about an outbreak of measles worst affecting the remote Kuf Ab and Kohistan districts of the province where poverty is widespread. “The measles outbreak has been spreading in the province for the past two months and has spread to ten districts, including the capital Faiz Abad”, he said, adding that so far no organization or health institution has come to their aid and many children have died due to the disease in Kuf Ab and Kohistan districts. Equally remote and poor, Ghor province in the central highlands of Afghanistan is the second flashpoint for the measles outbreak according to the Afghan authorities. The provincial health department head, Mohammad Nazim, told the Health Policy Watch that more than a thousand children have been referred to the province’s central hospital recently and 21 of whom have died because of measles. “The reason for the spread of measles is the non-implementation of the vaccination program firstly due to the coronavirus pandemic and then the security concerns and lack of funds”, he said. Crumbling Healthcare System In December 2021, a measles outbreak response immunisation campaign was carried out with the support of the WHO in some of the most affected provinces, reaching 1.5 million children. Battling for survival, Afghanistan’s fragile health system has been on the edge for months in the wake of the COVID-19 pandemic, the Taliban takeover of power and the subsequent US freezing of Afghanistan’s state reserves. In Ghor, the regional public hospital sources said the doctors and support staff is so overstretched and under-paid that it can collapse any moment in the wake of mounting cases of COVID-19 and now the measles outbreak. Kabul-based paediatrician Dr Zar Wali told the Health Policy Watch that malnutrition among children was severely compromising their immune system. “On a daily basis I am receiving dozens of child patients from the city (Kabul) as well as the nearby provinces, and there is this clear pattern of malnourishment in almost all, which makes them susceptible to all sorts of diseases”. This was echoed by the UN Children Fund (UNICEF) last week when it warned that as the humanitarian crisis deepens in Afghanistan, hospitals were receiving so many cases each day of children suffering complications associated with severe acute malnutrition. After relatively low transmission in 2019 and 2020, new infection cases have been increasing in all provinces since the end of July 2021, with the highest weekly toll observed so far occurring over the last four weeks. The WHO has warned that although the number of deaths is relatively low, the rapid rise in cases in January 2022 suggests that the number of deaths due to measles is likely to increase sharply in the coming weeks. Being endemic in Afghanistan, more than 25,000 children get killed by the measles virus annually, according to the Ministry of Public Health, and many more struggle with its impacts. The WHO has expressed willingness to prepare a plan for a larger measles outbreak response immunisation campaign, which will start in May (or earlier, if possible), aiming to reach more than 3 million children in Afghanistan. Image Credits: © UNICEF Afghanistan. African Medicines Agency Host Country Could be Selected by July 15/02/2022 Kerry Cullinan Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD The African Union could decide on the host country for the African Medicines Agency (AMA) as early as July, while the agency’s director-general should be appointed by the end of the year. This is according to Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD, the African Union’s development agency. The AU Assembly had recently decided to “do an assessment of the countries that have offered to host the AMA headquarters”, she told a workshop convened by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on Monday ahead of the EU-AU Summit which starts in Brussels on Thursday. “The AU Commission and AUDA-NEPAD are working together, and the teams are set to go out in the first week of March,” said Ndomondo-Sigonda, adding that the country visits may take two months to complete. “Once they are done, then the assessment report will be presented before the first meeting of the Conference of the State Parties that is planned to be held sometime in May,” she added. Whatever decision is made by this body would have to go to the AU Assembly during its meeting in in June or July, “so by July we will know which countries actually hosting the headquarters for the African Medicines Agency,” she added. The Assembly comprises of all Member State Heads of State and Government is the AU’s supreme policy and decision-making organ. Director-General may be appointed by year-end As far as the appointment of the head of the AMA – its director general – is concerned, this would take a little longer. First, the Conference of the State Parties would have to consider the terms of reference for the position at its May meeting, and advertisements will only go out after that. “By the time we get to know who has been appointed as the director-general, it will probably be quarter three or quarter four this year,” she said. She added that AMA was being established as “a specialised agency of the African Union with its autonomy in terms of financial and human resources, so it’s going to be operating differently from what you see with Africa Centres for Disease Control at the moment”. Meanwhile, UNAIDS Executive Director Winnie Byanyima welcomed the imminent establishment of the AMA. “Since the very beginning of the COVID crisis, the multilateral response may have failed us but African leadership has been remarkable,” said Byanyima at a workshop on Monday. “The newly created African Medicines Agency will harmonise medicine regulations, and negotiate joint purchasing and the manufacture of our own medicines.” European and African Pharma Sector Want Permanent Platform to Support African Development 14/02/2022 Kerry Cullinan A staff member at Afrigen, the mRNA hub in South Africa, prepares part of the vaccine. The major players in the European and African pharmaceutical sectors have called on the European Union (EU) and the African Union (AU) to support the creation of a permanent “business platform” to foster the pharma industry’s development in Africa. This emerged at a workshop Monday hosted by the the European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) along with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and other European-based pharma associations. The workshop was part of the European African Business Forum (EABF) taking place ahead of, and along with, the European Union–African Union Summit, which begins Thursday in Brussels. The business platform should support the development of EU and AU policies conducive to trade and “sustainable financing mechanisms models with access to low-interest capital” and appropriate incentives to encourage local, regional and international private sector investment, according to IFPMA Assistant Director-General Greg Perry, speaking at the Monday EABF session leading up to the Summit. Businesses also want a “stable business environment that respects business ethics and incentivises local innovation and entrepreneurship, including through intellectual property, ensure development and retention of local skilled workforces”, said Perry, reading from a joint statement by the EABF’s Healthcare Working Group, which also includes the European Federation of Pharmaceutical Manufacturers and Associations (EPFIA) and Vaccines Europe. The pharmaceutical sector also wants voluntary and mutually agreed upon technology transfers and joint ventures; timely product registration, harmonisation of regulation particularly through the African Medicines Agency, and the implementation of the African Continental Free Trade Area to eliminate non-trade barriers and foster international supply chain security. “We believe that creating this platform with the support of the EU and the AU, we could facilitate African and European partnerships, support existing continental and regulatory initiatives and create a win-win for both Africa and Europe,” said Perry. Where is the money that was promised? Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee Emmanuel Mujuru, representing the Federation of African Pharmaceutical Manufacturers (FAPMA), said that the African pharmaceutical industry was struggling to access affordable financing. “This financing has to both long-term in nature and have affordable interest rates, either in the form of loans or equity participation in already established African pharma management companies,” said Mujuru. He added that there was a significant opportunity for European investors as between 70 and 90% of essential medicines consumed in Africa were imported and that the pharmaceutical sector was growing at over 10% per annum, second only to Asia. Merck’s Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee, said that while setting up fill and finish operations “is easy to implement in two years”, he had tried to do so in three different African countries but “local private sector investors have never been able to get access to any finance”. “Why? The International Finance Corporation has announced $4 billion for the local vaccine manufacturing and the European Commission has announced one billion Euros,” asked Bendhaou “We also have to invest in the health system capacity because otherwise, you can have a nice factory in in South Africa, a beautiful factory in Egypt, producing hundreds of millions of doses but if you don’t have a health system in place for the uptake and to absorb this capacity,” he added. What about Gavi subsidies? Biovac CEO Patrick Tippoo Meanwhile, Patrick Tippoo, CEO of the South African company, Biovac and part of the African Vaccine Manufacturing Initiative (AVMI) leadership, said that much of Africa’s vaccine supply “comes in a subsidised form, partially or completely by Gavi through UNICEF”. “We know that Gavi drives prices down to make vaccines more affordable so more vaccines can be purchased and therefore distributed,” said Tippoo “We have a current situation where about 40 of the 54 countries depend on this mechanism. And therefore the market in Africa is actually in Copenhagen, as some people say. “This is a structural thing that will have to be addressed because, in order to stimulate and incentivize technology transfers, investment in skills, development, regulatory capacity building – and all the things that we repeat ad nauseum – there needs to be an assurance that there’s going to be a market when all of this is built,” he stressed. Tippoo added that African governments and other stakeholders had to understand that a “resilience premium” would need to be paid to ensure that pharmaceutical manufacturing capability is built in Africa. “There is no way in which vaccines coming out of Africa in the next five or 10 years can compete on a cost of goods perspective, with Indian manufacturer factories, or even multinationals because they’ve monetised the investment over time, and they have economies of scale,” he added. Diversification a ‘win-win’ for Africa, Europe and globally However, other participants pointed out that over the long-term, diversification of sources for pharma procurement is going to be a win win, given the comparatively limited number of suppliers, for some key global health products. Interruptions to key medical supply chains were particularly evident during the early stages of the COVID pandemic, exposing their fragility, even for more affluent countries. Sibilia Quilici, Executive Director, Vaccines Europe, pointed out that from the European perspective, too, it would be beneficial to reduce dependence on what is now a comparatively small number of suppliers, mainly from India and China, and integrate Africa’s supply chains with global ones: “In the context of this discussion on improving manufacturing capacities in Africa, also for APIs [active pharmaceutical ingredients] it is good to be aware that the EU, the largest API importer in the world is looking for supply chain diversification for products where dependence on a small number of suppliers from India and China is a concern. “This could be a win-win for Africa, EU, local and global industry”. Image Credits: Rodger Bosch for MPP/WHO, WHO . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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BioNTech To Ship Modular mRNA Vaccine Facilities in Containers to African Countries to Jump-start Production 16/02/2022 Elaine Ruth Fletcher Display in Marburg Germany of the BioNtainer container that will be shipped to Africa to jump-start mRNA vaccine manufacturing on the continent. The German-based BioNTech, which co-developed with Pfizer an mRNA COVID vaccine, said on Wednesday that it will set up modular “turnkey” mRNA vaccine facilities to produce the vaccine in Rwanda and Senegal in 2022 – with a fill-and-finish collaboration in Ghana as well. South Africa, which is the new hub for the WHO-supported mRNA vaccine R&D and manufacturing hub focusing on open-access products- may also join the initiative later, said the company in a press release. Speaking at a press briefing Wednesday morning, which included the presidents of Rwanda, Ghana and Senegal, as well as WHO and Africa CDC, BioNTech CEO Ugur Sahin, described the new cutting-edge BioNTainer initiative for vaccine production as – following “the most elementary principle of reducing complexity by copying the manufacturing units having modular action unit and by copying the process and transferring it to another place. “But this is not about innovation alone, it it is about collaboration,” Sahin added, “for example, implementation of the manufacturing side, about regulation, about supply of vaccines… no one can do it alone, we have to do it together,” Sahin said. He said that the first containers would be delivered to Africa in mid-2022 “and we want to start with the manufacturing of the first vaccine batches in the first months after we deliver the containers.” The new production facilities are designed to produce not only COVID-19 vaccines, but other “future vaccines” in the planning for malaria, tuberculosis and HIV: “If these vaccines are successful and approved they will be produced in Africa, and these containers can be useful.” Welcomed by African leaders Left to right: BioNTech CMO Özlem Türeci and CEO Ugur Sahin; with African heads of state, Nana Akufo-Addo (Ghana); Macky Sall (Senegal) and Paul Kagame (Rwanda) and WHO’s Director General Tedros Adhanom Ghebreyesus; and kNUP’s Holm Keller at BioNtech briefing on new BioNTainer plug-and-play facility. The initiative was roundly welcomed by the heads of Ghana, Senegal, Rwanda – all of whom were present at the briefing – as well as the heads of WHO and Africa CDC. “Today is a historic day. Today, we are putting an end to the vaccine injustice that has occurred during the pandemic, where Africa was left by the wayside,” said Senegal’s President Macky Sall, who opened Wednesday’s public briefing in Marburg, Germany, where the three African heads of state had been meeting with BioNTech officials over the past several days on the BioNtainer concept. “Thanks to the innovation of BioNtech, with the BioNtainer, we are going to transfer the technology to Africa, to produce the API for the mRNA vaccines, along with the fill-and-finish. And we can thus be able to produce COVID-19 vaccines, as well as having the potential to produce vaccines for other diseases,” he said. “We commend this cooperation between Europe and Africa, between BioNTech and African countries, as well as foundations and development banks that are providing the financial backing, so that we can very soon produce these vaccines on our continent.” Africa CDC head John Nkengasong also welcomes the new BioNTech initiative Meanwhile, Africa CDC head John Nkengasong praised BioNTech for “showing leadership” on the innovative ‘turn key’ production facilities, saying, “You are teaching us how to fish, and not giving us a fish….The African Union and Africa CDC will continue to work with you in this journey.” And Ghana’s President Nana Akufo-Addo, said his country would be dedicating it’s National Vaccine Institute to support the initiative to develop “partnerships for vaccine deployment and manufacturing in areas of funding, clinical trials and fill-and-finish capacity.” Ghana will set up a fill-and-finish facility soon, he said, in order to perform the last step of the BioNTech process – to be completed outside of the modular vaccine factory containers. BioNTainer concept explained at BioNTech press briefing on Wednesday 16 February 2022 WHO affirms initiative has African “ownership” Meanwhile, WHO’s Director General Dr Tedros Adhanom Ghebreyesus expressed support for the new project – despite the criticism that had been levelled at it in a recent BMJ investigation, which had portrayed it as a potential competition to the new WHO-supported mRNA vaccine manufacturing hub set up in South Africa, which aims to promote an open-license approach to vaccine manufacturing – in contrast to collaborations built around the bilateral licensing of patented products, such as Pfizer’s. Tedros visited the South African mRNA hub, which has replicated a version of the Moderna mRNA vaccine, just last Friday. “Many colleagues have been discouraged about the success of this project,” said Tedros, in an oblique reference to the earlier criticism levelled at the notion of shipping ready-made vaccine facilities in containers to Africa. He underlined that the endorsement by African national and African Union leaders shows that the BioNTech initiative is viable: “Their presence shows political commitment, their presence shows ownership. And when projects are owned and political commitment is provided from the leaders, projects normally succeed…. failure is not an option for this project, from what I observed,” said Tedros. .@DrTedros @WHO in oblique reference to prior @BMJ criticism of the initiative says "many colleagues have been discouraged about the success of this project….one thing that convinces me is that the presence of these leaders – their presence shows ownership." https://t.co/0GvaqaRSJ9 pic.twitter.com/lZFEBRQmiD — Health Policy Watch – Global Health News Reporting (@HealthPolicyW) February 16, 2022 ‘Miniaturized’ and standardized mRNA production BioNTech COO Sierk Poetting at a meeting briefing on the BioNTainer initiative. The new manufacturing systems effectively takes advantage of the comparatively small size of mRNA vaccines inputs, and their unique production technology, to “miniaturize” and standardise the vaccine production process, said BioNTech’s BioNTech Chief Operating Office (COO) Sierk Poetting at a press conference later Wednesday afternoon. He said innovation had been developed at Pfizer’s Marburg, Germany facility, which is Pfizer’s largest manufacturing operation, and would also now serve as global quality control center for the plug-and-play systems sent to Africa. The modular facilities would be built of ISO-standard 40 foot containers “We can put them on trucks, boats, or planes and ship those manufacturing BioNtainers to the world, to the target locations,” said Poetting. “The power of the mRNA drug class is that it is versatile and can be prepared rapidly,” said Sahin, noting that the facilities would also serve the production of future mRNA vaccines under development by Pfizer for other diseases. Turnkey facilities will be pre-approved as GMP complaint in Germany Turnkey facilities will be pre-approved as GMP compliant in Germany and then shipped to Africa – BioNTech CEO Sahin Sahin said that the modular facilities could be pre-approved as GMP compliant at Pfizer’s Marburg, Germany plant where the turnkey solution was developed – and which will supervise the initiative: “The turnkey package includes the modular production unit, GMP compliance set up, and personnel training to ensure that we can transfer the technology,” he explained. “The elements of the container-based, plug-and-play approach was modular design.. by having this standardized design, we can ensure that the facility, once approved somewhere, can be transferred to another place, and with a little additional work, the process can be GMP [compliant]. That means that the facility would be built and pre-approved to meet European manufacturing requirements, and once transferred to Africa, could be quickly approved by national regulatory processes as well, ensuring a quick start to manufacturing, said Sahin. Turnkey facility includes “plug and play” production meeting GMP standards, said BioNTech’s Ugur Sahin, at the press conference. There would be six containers – six for producing the active pharmaceutical ingredient and six more for producing the final drug product. They would be set up in an air-conditioned factory hall, equipped with refrigeration and other basic infrastructure, Poetting explained. ‘Fill and finish’ would take place at other sites in collaboration with national and local African partners. Sahin said that the first facility would be set up in mid-2022, with the aim of being fully operational by the end of the year. The facilities could produce up to 50 million doses a year – although actual production would vary by demand. Products would be sold at cost in African Union countries. “The goal of the BioNtainer is to reduce the cost and the speed of the development of manufacturing facilities, and provide a solution which is suitable for the needs of people living in this region,” said Sahin. Did BioNTech’s kENUP consultants try to undermine South Africa’s mRNA vaccine hub? Tedros visits Stellenbosch University’s Biomedical Research Institute & Centre for Epidemic Response & Innovation on 11 February, 2022, part of South Africa’s WHO co-sponsored mRNA vaccine hub. Asked why BioNTech had decided not to share Pfizer’s vaccine technology with the new WHO-supported mRNA vaccine tech transfer hub in South Africa, Poetting said that the company would collaborate by taking staff that are trained there to help manage the new BioNTech manufacturing facilities – which would initially be staffed by Pfizer’s European teams. “We will onboard the local teams and do the knowledge transfer and the production together,” Poetting said, adding, “we are actually collaborating with the transfer hubs. We will work together with the transfer hubs on staffing the units, on training the units, and for distribution of the units” he said. But for actual production processes, the BioNTainer facilities could be set up and become operational sooner, he asserted. Meanwhile, Sahin refused to comment on the recent allegations, published in The BMJ that the kENUP Foundation, a BioNTech consultancy that helped develop the BioNTainer initiative, had actually sought to undermine the South African tech transfer hub – which along with training African scientists and technicians also aims to develop open-access versions of mRNA vaccines. Holm Keller of the kENUP Foundation, moderating BioNTech’s launch of its new “BioNTainer’ initiative on Wednesday; kENUP is also alleged to have sought the “termination” of the WHO-supported South African mRNA hub. According to The BMJ, kENUP had sent a mission report to the South African government after a visit last August, saying that the hub’s project “of copying the manufacturing process of Moderna’s COVID-19 vaccine should be terminated immediately. This is to prevent damage to Afrigen, BioVac, and Moderna . . . “Provided that the release from patent cover will be granted by Moderna only during the pandemic, the sustainability outlook for this project of the WHO Vaccine Technology Transfer Hub is not favourable,” stated the report, obtained by The BMJ. Scientists at Afrigen have since said that they managed to replicate the Moderna mRNA vaccine – without assistance from the US-based pharma firm, which has nonetheless promised not to enforce its patents on its COVID-19 vaccine during the pandemic. “We can’t comment on behalf of kENUP, and also not on behalf of WHO,” Sahin said. “We can just state that at the moment several projects with the same goal are underway, and we welcome any projects with the same goals. What is important at the beginning, of course, to understand the overall framework, and what are the specific aspects of the individual partners, and identify ways to collaborate.” New projects on African continent – a turning point… In fact, the silver lining in the vaccine inequalities in Africa, sharply highlighted by the COVID pandemic, is the surge of new vaccine manufacturing initiatives, said Greg Perry, Assistant Director of the International Federation of Pharmaceutical Manufacturers and Associations, in a comment to Health Policy Watch. “What is significant is how much is happening on the African continent, and much from private sector, from J&J ‘s agreement with Aspen Pharmacare, to the BioNTech- Biovac partnership on manufacturing and distribution activities, to the various BioNTech actions announced today,” he said. He made his comment shortly after the new head of Tanzania, formerly one of the continent’s most COVID vaccine-hestitant countries, said that it, too, would like to set up a vaccine manufacturing plant to tackle COVD and other diseases. New President, Samia Suluhu Hassan described her plans at a meeting with European Union President Charles Michel in Brussels, BBC reported. Meanwhile, in Nigeria, a vigorous debate over the creation of a national vaccine manufacturing initiative is also underway. “We should be open to all these initiatives,” Perry said. “But what is key is that are long term, sustainable, and based on voluntary partnership. Moreover they will all face the same challenges, needs for skills and regulatory support; long- term financing and demand stability. It’s these real challenges and solutions we are talking about in Brussels this week at the European-African Business Forum,” he said, referring to a pharma meeting ongoing this week ahead of European Union-African Union summit. Ont the other side of the fence, pharma critics that have looked at the South African mRNA hub, as the seedling from which new patent-free modes of vaccines manufacture might take root and flourish on the continent, were not so enthusiastic about the new BioNTech initiative. “When local production in Africa is done under monopoly control of Pfizer/BioNtec, how does that increase technological autonomy and resilience?” asked Els Torreele, a visiting fellow at the Institute for Innovation and Public Purpose at University College London, in a tweet. https://twitter.com/ElsTorreele/status/1493974017967067142 Image Credits: BioNTech, BioNTech , @StellenboschUni, BioNTech Press conference . Depression Remains Overlooked and Underfunded; Experts Call to Reduce Global Burden 16/02/2022 Raisa Santos Street scene in Metro Manila, Intramurous district, Philippines. 80-90% of those with depression are left untreated or undiagnosed in low- and middle-income countries. Homelessness is one adverse experience that may cause depression. With about half of people suffering from depression in high income countries untreated or undiagnosed, with this number rising to 80-90% in low- and middle-income countries, a Lancet and World Psychiatric Association Commission have called for a unified response against this global crisis to reduce the burden of depression. Depression is estimated to impact 5% of adults globally, with its onset most frequent in young people. COVID-19 has caused ‘mass trauma’ worldwide and has further worsened mental health for millions, creating additional challenges with isolation, bereavement, uncertainty, hardship, and limited access to healthcare. To combat the crisis, the Commission’s ‘Time for united action on depression’ calls for a concerted and collaborative front from all – government, healthcare providers, researchers, and people living with depression, to improve care and prevention, fill knowledge gaps, and increase awareness for one of the leading causes of avoidable suffering and premature death worldwide. “Depression is a global health crisis that demands responses at multiple levels,” said Commision Chair Professor Helen Herrman. “This Commission offers an important opportunity for united action to transform approaches to mental health care and prevention globally.” The report is authored by 25 experts across 11 countries, from experts in neuroscience to global health. It is advised by people with experience of depression. Myths surrounding depression fuel inaction Myths surrounding mental health have fueled inaction. While 70-80% of people who die by suicide in high income countries, and around half in LMIC, suffered from mental illness, with depression as the most common cause, myths surrounding this health condition have fueled global inaction towards depression. The myths include the misconception that depression is simply sadness, a sign of weakness, or restricted to certain cultural groups. Depression also has an under-recognized social and economic toll, with the loss in economic productivity linked to depression costing the global economy an estimated $1 trillion a year. “There is arguably no other health condition which is as common, as burdensome, as universal, or as treatable as depression, yet it receives little policy attention and resources”, said Commission Co-Chair Associate Professor Christian Kieling, of the Brazil-based Universidade Federal do Rio Grande do Sul. The Commission does stress that depression is distinctly a health condition that is characterized by persistence, as it inhibits daily functioning and may lead to long-term health consequences. Depression may also impact anyone, regardless of gender, background, social class, and age, though symptoms and signs of depression may vary among groups. Society and individual strategies proposed Mental health services for children and adolescents have been disrupted due to COVID-19. Solutions to reduce the global burden of depression need to prevent adverse experiences in childhood. Whole-of-society and individual level strategies have been proposed by the Commission to prevent depression, focusing on reduced exposure to adverse experiences in childhood, lifestyle factors, and other stressful events, including financial crisis or bereavement. “Prevention is the most neglected aspect of depression. This in part because most interventions are outside of the health sector”, said co-author Dr Lakshmi Vijayakumar from SNEHA, Suicide Prevention Centre and Voluntary Health Services of Chennai, India. Vijayakumar further noted how crucial these prevention efforts are. “In the face of the lifelong effects of adolescent depression, from difficulty in school and future relationships to risk of substance abuse, self-harm, and suicide, investing in depression prevention is excellent value for money. It is crucial that we put into practice evidence-based interventions that support parenting, reduce violence in the family, and bullying at school, as well promoting mental health at work and addressing loneliness in older adults.” Current classification of depression is ‘too simplistic’ The current classification that places people with symptoms of depression into just two categories – either they have clinical depression or not – remains too simplistic, says the Commission. Instead, the Commission supports a personalized, staged approach to depression care that tailors and recommends interventions to the individual and the severity of their condition. These treatments range from self-help to lifestyle changes to psychological therapies. “No two individuals share the exact life story and constitution, which ultimately leads to a unique experience of depression and different needs for help, support, and treatment”, explained Commission Co-Chair Professor Vikram Patel from US-based Harvard Medical School. In addition, the Commission also proposes collaborative care strategies that incorporate locally recruited, widely available non-specialists such as community health workers and lay counselors. Ultimately, they conclude that greater investment is needed on behalf of the government to reduce the damaging impact of poverty, gender inequity, and other social inequalities on mental health. Said Patel: “Tackling the climate emergency, the COVID-19 pandemic and other global and regional emergencies that exacerbate existing inequities and threats to health, including pursuit of the UN Sustainable Development Goals, must also be vital parts of efforts to prevent depression.” Image Credits: Wayne S. Grazio, Nenad Stojkovic/Flickr, WHO/NOOR/Sebastian Liste. US and Africa Plan to Harness PEPFAR Networks to Increase COVID Vaccine Uptake 15/02/2022 Kerry Cullinan US Secretary of State Antony Blinken CAPE TOWN – The US and Africa intend to use the well-established community networks supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) to improve the uptake of COVID-19 vaccines in Africa. The initaitive would build upon the infrastructure developed since PEPFAR entered as a major player on the African AIDS scene in 2003. In addition, USAID has launched an initiative called Global VAX to support the World Health Organization (WHO) target of vaccinating 70% of the world’s population by mid-year against COVID-19, and will soon be announcing priority countries in Africa. This is according to US State official Mary Beth Goodman, who briefed African journalists on Tuesday on the COVID-19 Global Action Meeting convened by US Secretary of State Antony Blinken on Monday. “We’re leveraging opportunities through things like PEPFAR, which has an extraordinary network across the African continent in combating HIV/AIDS and has a network of community workers and leaders who are helping to work with us to also talk about some of the importance of COVID,” said Goodman, who is Acting Coordinator for Global COVID-19 Response and Health Security at the US Department of State. “The same is true of our Presidential Malaria Initiative and other efforts that have long been in place on the continent. “We actually have launched through USAID and the Centre for Disease Control, a programme that we’re calling Global VAX,” added Goodman. “The effort behind Global Vax is all about the uptake issues. How do we turn vaccines into vaccinations? How do we connect the dots to make sure that we are getting these vaccines distributed in a way that allows more people to have the opportunity to take the vaccine and that allows some of these countries which are lagging to meet the 70% target?” Blinken’s six-point ‘GAP’ plan Ghanian health worker Evelyn Narkie Dowuona holds up her COVID-19 vaccination card. Blinken presented a six-point COVID-19 Prioritized Global Action Plan for Enhanced Engagement (GAP) to foreign ministers and senior leaders from countries and international organizations invited to his virtual meeting. “Together, we identified urgent gaps in response activities and aligned around specific roles to advance global efforts aimed at bringing this pandemic under control and strengthening readiness for future global health threats. We agreed that more political leadership is needed to save lives and end this pandemic cycle in 2022,” said Blinken in a statement issued late Monday. He identified the “six lines of the global effort to respond to acute pandemic needs” as: Getting Shots in Arms: coordinated efforts to improve vaccine readiness and logistics, in step with increased donations and procurement, toward the goal of at least 70% of the population fully vaccinated with quality, safe, and effective vaccines by September 2022. Bolstering Supply Chain Resilience: mechanisms to facilitate sufficient and steady supplies of critical products and materials to break this cycle of the COVID-19 pandemic, including establishing mechanisms to identify and remove medical supply chain bottlenecks. Addressing Information Gaps: global efforts to enhance vaccine confidence and combat the spread of false information, enlisting regional champions and medical, civil society, young people, and faith leaders to use evidence-based, accurate, locally relevant messaging. Supporting Health Workers: protecting the health, safety, and wellbeing of frontline health workers, including the need to improve their training and numbers to effectively support the COVID-19 response. Ensuring Acute Non-Vaccine Interventions, including the provision of therapeutics, testing regimes, and oxygen where needed most. Strengthening Global Health Security Architecture to end the current pandemic and. secure future preparedness for health emergencies at the national, regional and global level. Blinken also announced a direct donation of 5 million doses of Johnson & Johnson’s COVID-19 vaccine to the African Vaccine Acquisition Trust (AVAT), the African Union’s vaccine procurement and distribution effort. The US has now donated more than 155 million doses to Africa and 435 million doses worldwide. Praise for Uganda vaccine effort Ugandan Health Minister Dr Jane Ruth Aceng (left) and French Ambassador to Uganda Jules-Armand Aniambossou with donated AstraZeneca COVID-19 vaccines. In his address to the GAP meeting, Blinken praised Uganda for its massive vaccination effort in November and December last year as an example of what is possible. “In early November, only 14% of all Ugandan adults had received their first dose of the vaccine,” said Blinken. “Then a major team effort commenced. The Ugandan government led a mass vaccination campaign, carried out by hundreds of health care workers,” he added, and “by late December, almost half of all adults in Uganda had received their first shot – from 14 to 47% in just six weeks”. Participants in the GAP meeting included Australia, Canada, Colombia, France, Germany, India, Indonesia, Italy, Japan, the Republic of Korea, New Zealand, Saudi Arabia, Senegal, South Africa,Spain, UK, the African Union/Africa Centres for Disease Control, the European Commission, and the WHO. They have all committed to coordinating parts of the six key areas identified. Meanwhile, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the meeting that “in some countries, high vaccine coverage, combined with the lower severity of Omicron, is driving a false narrative that the pandemic is over”. However, the low vaccine coverage and low testing rates in other countries “are creating the ideal conditions for new variants to emerge”, warned Tedros, adding that 116 countries are off track to vaccinate 70% of the population by the middle of this year. “We can bring the pandemic under control this year – but we are at increased risk of squandering that opportunity,” said Tedros, adding that “in many countries, the issues are not primarily a problem of absorptive capacity. We need to urgently support political leaders to accelerate the rollout of vaccines”. Image Credits: WHO, Health Journalist Network. Malnourished Afghan Children in The Grasp of Measles Outbreak 15/02/2022 Shadi Khan A mother and her child in the Haji camp for internally displaced people in Kandahar, Afghanistan. More and more children are losing their lives to a measles outbreak in Afghanistan as the country struggles with a humanitarian crisis under the US sanctions on the country’s Taliban regime. Following the Taliban’s takeover of Afghanistan, the US Department of the Treasury froze Afghanistan Central Bank’s reserves, mostly held in US banks, as the Taliban has been on its “specially designated global terrorist group” since 2002, and any support for the group is illegal. The measles outbreak has hit the malnourished children hard in some of the already marginalized and poor communities in Paktika, Ghor, Badakhshan and other provinces of Afghanistan. The World Health Organization (WHO) last week confirmed that the number of cases and deaths increased by 18% in the week of 24 January, and 40% in the week of 31 January. Health Policy Watch reported last week that WHO Director-General Dr Tedros Adhanom Ghebreyesus met with the Taliban in Geneva to discuss Afghanistan’s health challenges. Struggle for meals in the pandemic According to the global health body, as many as 35,319 suspected cases of measles and 156 deaths have been reported in Afghanistan between 1 January 2021 and 29 January 2022. Of these, 3,221 cases were laboratory confirmed while 91% of these cases and 97% of these deaths were in children under five years of age. The WHO says that the rise in measles cases is especially concerning because of the extremely high levels of malnutrition in Afghanistan. This weakens immunity, making people more vulnerable to illness and death from diseases like measles – especially children. Local civil society activist in Paktika, Abdul Bari, mentioned that with the fall of the previous government, thousands of people lost their jobs and could not support families for months now that ultimately led to malnourishment and spread of the diseases. “Many families who were doing relatively well in the past now find them among the so many very poor in the society that struggle to feed one or two meals in Paktika”, he said. Mirwais Hospital, Kandahar – The hunger and poverty is more visible than ever in Afghanistan especially on the faces of the youngest victims of the crisis. Hospitals and healthcare facilities are filling up with babies and children suffering from malnutrition pic.twitter.com/J8B6VyEocS — Yalda Hakim (@SkyYaldaHakim) November 29, 2021 Authorities in Badakhshan province told the Health Policy Watch about an outbreak of measles worst affecting the remote Kuf Ab and Kohistan districts of the province where poverty is widespread. “The measles outbreak has been spreading in the province for the past two months and has spread to ten districts, including the capital Faiz Abad”, he said, adding that so far no organization or health institution has come to their aid and many children have died due to the disease in Kuf Ab and Kohistan districts. Equally remote and poor, Ghor province in the central highlands of Afghanistan is the second flashpoint for the measles outbreak according to the Afghan authorities. The provincial health department head, Mohammad Nazim, told the Health Policy Watch that more than a thousand children have been referred to the province’s central hospital recently and 21 of whom have died because of measles. “The reason for the spread of measles is the non-implementation of the vaccination program firstly due to the coronavirus pandemic and then the security concerns and lack of funds”, he said. Crumbling Healthcare System In December 2021, a measles outbreak response immunisation campaign was carried out with the support of the WHO in some of the most affected provinces, reaching 1.5 million children. Battling for survival, Afghanistan’s fragile health system has been on the edge for months in the wake of the COVID-19 pandemic, the Taliban takeover of power and the subsequent US freezing of Afghanistan’s state reserves. In Ghor, the regional public hospital sources said the doctors and support staff is so overstretched and under-paid that it can collapse any moment in the wake of mounting cases of COVID-19 and now the measles outbreak. Kabul-based paediatrician Dr Zar Wali told the Health Policy Watch that malnutrition among children was severely compromising their immune system. “On a daily basis I am receiving dozens of child patients from the city (Kabul) as well as the nearby provinces, and there is this clear pattern of malnourishment in almost all, which makes them susceptible to all sorts of diseases”. This was echoed by the UN Children Fund (UNICEF) last week when it warned that as the humanitarian crisis deepens in Afghanistan, hospitals were receiving so many cases each day of children suffering complications associated with severe acute malnutrition. After relatively low transmission in 2019 and 2020, new infection cases have been increasing in all provinces since the end of July 2021, with the highest weekly toll observed so far occurring over the last four weeks. The WHO has warned that although the number of deaths is relatively low, the rapid rise in cases in January 2022 suggests that the number of deaths due to measles is likely to increase sharply in the coming weeks. Being endemic in Afghanistan, more than 25,000 children get killed by the measles virus annually, according to the Ministry of Public Health, and many more struggle with its impacts. The WHO has expressed willingness to prepare a plan for a larger measles outbreak response immunisation campaign, which will start in May (or earlier, if possible), aiming to reach more than 3 million children in Afghanistan. Image Credits: © UNICEF Afghanistan. African Medicines Agency Host Country Could be Selected by July 15/02/2022 Kerry Cullinan Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD The African Union could decide on the host country for the African Medicines Agency (AMA) as early as July, while the agency’s director-general should be appointed by the end of the year. This is according to Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD, the African Union’s development agency. The AU Assembly had recently decided to “do an assessment of the countries that have offered to host the AMA headquarters”, she told a workshop convened by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on Monday ahead of the EU-AU Summit which starts in Brussels on Thursday. “The AU Commission and AUDA-NEPAD are working together, and the teams are set to go out in the first week of March,” said Ndomondo-Sigonda, adding that the country visits may take two months to complete. “Once they are done, then the assessment report will be presented before the first meeting of the Conference of the State Parties that is planned to be held sometime in May,” she added. Whatever decision is made by this body would have to go to the AU Assembly during its meeting in in June or July, “so by July we will know which countries actually hosting the headquarters for the African Medicines Agency,” she added. The Assembly comprises of all Member State Heads of State and Government is the AU’s supreme policy and decision-making organ. Director-General may be appointed by year-end As far as the appointment of the head of the AMA – its director general – is concerned, this would take a little longer. First, the Conference of the State Parties would have to consider the terms of reference for the position at its May meeting, and advertisements will only go out after that. “By the time we get to know who has been appointed as the director-general, it will probably be quarter three or quarter four this year,” she said. She added that AMA was being established as “a specialised agency of the African Union with its autonomy in terms of financial and human resources, so it’s going to be operating differently from what you see with Africa Centres for Disease Control at the moment”. Meanwhile, UNAIDS Executive Director Winnie Byanyima welcomed the imminent establishment of the AMA. “Since the very beginning of the COVID crisis, the multilateral response may have failed us but African leadership has been remarkable,” said Byanyima at a workshop on Monday. “The newly created African Medicines Agency will harmonise medicine regulations, and negotiate joint purchasing and the manufacture of our own medicines.” European and African Pharma Sector Want Permanent Platform to Support African Development 14/02/2022 Kerry Cullinan A staff member at Afrigen, the mRNA hub in South Africa, prepares part of the vaccine. The major players in the European and African pharmaceutical sectors have called on the European Union (EU) and the African Union (AU) to support the creation of a permanent “business platform” to foster the pharma industry’s development in Africa. This emerged at a workshop Monday hosted by the the European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) along with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and other European-based pharma associations. The workshop was part of the European African Business Forum (EABF) taking place ahead of, and along with, the European Union–African Union Summit, which begins Thursday in Brussels. The business platform should support the development of EU and AU policies conducive to trade and “sustainable financing mechanisms models with access to low-interest capital” and appropriate incentives to encourage local, regional and international private sector investment, according to IFPMA Assistant Director-General Greg Perry, speaking at the Monday EABF session leading up to the Summit. Businesses also want a “stable business environment that respects business ethics and incentivises local innovation and entrepreneurship, including through intellectual property, ensure development and retention of local skilled workforces”, said Perry, reading from a joint statement by the EABF’s Healthcare Working Group, which also includes the European Federation of Pharmaceutical Manufacturers and Associations (EPFIA) and Vaccines Europe. The pharmaceutical sector also wants voluntary and mutually agreed upon technology transfers and joint ventures; timely product registration, harmonisation of regulation particularly through the African Medicines Agency, and the implementation of the African Continental Free Trade Area to eliminate non-trade barriers and foster international supply chain security. “We believe that creating this platform with the support of the EU and the AU, we could facilitate African and European partnerships, support existing continental and regulatory initiatives and create a win-win for both Africa and Europe,” said Perry. Where is the money that was promised? Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee Emmanuel Mujuru, representing the Federation of African Pharmaceutical Manufacturers (FAPMA), said that the African pharmaceutical industry was struggling to access affordable financing. “This financing has to both long-term in nature and have affordable interest rates, either in the form of loans or equity participation in already established African pharma management companies,” said Mujuru. He added that there was a significant opportunity for European investors as between 70 and 90% of essential medicines consumed in Africa were imported and that the pharmaceutical sector was growing at over 10% per annum, second only to Asia. Merck’s Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee, said that while setting up fill and finish operations “is easy to implement in two years”, he had tried to do so in three different African countries but “local private sector investors have never been able to get access to any finance”. “Why? The International Finance Corporation has announced $4 billion for the local vaccine manufacturing and the European Commission has announced one billion Euros,” asked Bendhaou “We also have to invest in the health system capacity because otherwise, you can have a nice factory in in South Africa, a beautiful factory in Egypt, producing hundreds of millions of doses but if you don’t have a health system in place for the uptake and to absorb this capacity,” he added. What about Gavi subsidies? Biovac CEO Patrick Tippoo Meanwhile, Patrick Tippoo, CEO of the South African company, Biovac and part of the African Vaccine Manufacturing Initiative (AVMI) leadership, said that much of Africa’s vaccine supply “comes in a subsidised form, partially or completely by Gavi through UNICEF”. “We know that Gavi drives prices down to make vaccines more affordable so more vaccines can be purchased and therefore distributed,” said Tippoo “We have a current situation where about 40 of the 54 countries depend on this mechanism. And therefore the market in Africa is actually in Copenhagen, as some people say. “This is a structural thing that will have to be addressed because, in order to stimulate and incentivize technology transfers, investment in skills, development, regulatory capacity building – and all the things that we repeat ad nauseum – there needs to be an assurance that there’s going to be a market when all of this is built,” he stressed. Tippoo added that African governments and other stakeholders had to understand that a “resilience premium” would need to be paid to ensure that pharmaceutical manufacturing capability is built in Africa. “There is no way in which vaccines coming out of Africa in the next five or 10 years can compete on a cost of goods perspective, with Indian manufacturer factories, or even multinationals because they’ve monetised the investment over time, and they have economies of scale,” he added. Diversification a ‘win-win’ for Africa, Europe and globally However, other participants pointed out that over the long-term, diversification of sources for pharma procurement is going to be a win win, given the comparatively limited number of suppliers, for some key global health products. Interruptions to key medical supply chains were particularly evident during the early stages of the COVID pandemic, exposing their fragility, even for more affluent countries. Sibilia Quilici, Executive Director, Vaccines Europe, pointed out that from the European perspective, too, it would be beneficial to reduce dependence on what is now a comparatively small number of suppliers, mainly from India and China, and integrate Africa’s supply chains with global ones: “In the context of this discussion on improving manufacturing capacities in Africa, also for APIs [active pharmaceutical ingredients] it is good to be aware that the EU, the largest API importer in the world is looking for supply chain diversification for products where dependence on a small number of suppliers from India and China is a concern. “This could be a win-win for Africa, EU, local and global industry”. Image Credits: Rodger Bosch for MPP/WHO, WHO . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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Depression Remains Overlooked and Underfunded; Experts Call to Reduce Global Burden 16/02/2022 Raisa Santos Street scene in Metro Manila, Intramurous district, Philippines. 80-90% of those with depression are left untreated or undiagnosed in low- and middle-income countries. Homelessness is one adverse experience that may cause depression. With about half of people suffering from depression in high income countries untreated or undiagnosed, with this number rising to 80-90% in low- and middle-income countries, a Lancet and World Psychiatric Association Commission have called for a unified response against this global crisis to reduce the burden of depression. Depression is estimated to impact 5% of adults globally, with its onset most frequent in young people. COVID-19 has caused ‘mass trauma’ worldwide and has further worsened mental health for millions, creating additional challenges with isolation, bereavement, uncertainty, hardship, and limited access to healthcare. To combat the crisis, the Commission’s ‘Time for united action on depression’ calls for a concerted and collaborative front from all – government, healthcare providers, researchers, and people living with depression, to improve care and prevention, fill knowledge gaps, and increase awareness for one of the leading causes of avoidable suffering and premature death worldwide. “Depression is a global health crisis that demands responses at multiple levels,” said Commision Chair Professor Helen Herrman. “This Commission offers an important opportunity for united action to transform approaches to mental health care and prevention globally.” The report is authored by 25 experts across 11 countries, from experts in neuroscience to global health. It is advised by people with experience of depression. Myths surrounding depression fuel inaction Myths surrounding mental health have fueled inaction. While 70-80% of people who die by suicide in high income countries, and around half in LMIC, suffered from mental illness, with depression as the most common cause, myths surrounding this health condition have fueled global inaction towards depression. The myths include the misconception that depression is simply sadness, a sign of weakness, or restricted to certain cultural groups. Depression also has an under-recognized social and economic toll, with the loss in economic productivity linked to depression costing the global economy an estimated $1 trillion a year. “There is arguably no other health condition which is as common, as burdensome, as universal, or as treatable as depression, yet it receives little policy attention and resources”, said Commission Co-Chair Associate Professor Christian Kieling, of the Brazil-based Universidade Federal do Rio Grande do Sul. The Commission does stress that depression is distinctly a health condition that is characterized by persistence, as it inhibits daily functioning and may lead to long-term health consequences. Depression may also impact anyone, regardless of gender, background, social class, and age, though symptoms and signs of depression may vary among groups. Society and individual strategies proposed Mental health services for children and adolescents have been disrupted due to COVID-19. Solutions to reduce the global burden of depression need to prevent adverse experiences in childhood. Whole-of-society and individual level strategies have been proposed by the Commission to prevent depression, focusing on reduced exposure to adverse experiences in childhood, lifestyle factors, and other stressful events, including financial crisis or bereavement. “Prevention is the most neglected aspect of depression. This in part because most interventions are outside of the health sector”, said co-author Dr Lakshmi Vijayakumar from SNEHA, Suicide Prevention Centre and Voluntary Health Services of Chennai, India. Vijayakumar further noted how crucial these prevention efforts are. “In the face of the lifelong effects of adolescent depression, from difficulty in school and future relationships to risk of substance abuse, self-harm, and suicide, investing in depression prevention is excellent value for money. It is crucial that we put into practice evidence-based interventions that support parenting, reduce violence in the family, and bullying at school, as well promoting mental health at work and addressing loneliness in older adults.” Current classification of depression is ‘too simplistic’ The current classification that places people with symptoms of depression into just two categories – either they have clinical depression or not – remains too simplistic, says the Commission. Instead, the Commission supports a personalized, staged approach to depression care that tailors and recommends interventions to the individual and the severity of their condition. These treatments range from self-help to lifestyle changes to psychological therapies. “No two individuals share the exact life story and constitution, which ultimately leads to a unique experience of depression and different needs for help, support, and treatment”, explained Commission Co-Chair Professor Vikram Patel from US-based Harvard Medical School. In addition, the Commission also proposes collaborative care strategies that incorporate locally recruited, widely available non-specialists such as community health workers and lay counselors. Ultimately, they conclude that greater investment is needed on behalf of the government to reduce the damaging impact of poverty, gender inequity, and other social inequalities on mental health. Said Patel: “Tackling the climate emergency, the COVID-19 pandemic and other global and regional emergencies that exacerbate existing inequities and threats to health, including pursuit of the UN Sustainable Development Goals, must also be vital parts of efforts to prevent depression.” Image Credits: Wayne S. Grazio, Nenad Stojkovic/Flickr, WHO/NOOR/Sebastian Liste. US and Africa Plan to Harness PEPFAR Networks to Increase COVID Vaccine Uptake 15/02/2022 Kerry Cullinan US Secretary of State Antony Blinken CAPE TOWN – The US and Africa intend to use the well-established community networks supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) to improve the uptake of COVID-19 vaccines in Africa. The initaitive would build upon the infrastructure developed since PEPFAR entered as a major player on the African AIDS scene in 2003. In addition, USAID has launched an initiative called Global VAX to support the World Health Organization (WHO) target of vaccinating 70% of the world’s population by mid-year against COVID-19, and will soon be announcing priority countries in Africa. This is according to US State official Mary Beth Goodman, who briefed African journalists on Tuesday on the COVID-19 Global Action Meeting convened by US Secretary of State Antony Blinken on Monday. “We’re leveraging opportunities through things like PEPFAR, which has an extraordinary network across the African continent in combating HIV/AIDS and has a network of community workers and leaders who are helping to work with us to also talk about some of the importance of COVID,” said Goodman, who is Acting Coordinator for Global COVID-19 Response and Health Security at the US Department of State. “The same is true of our Presidential Malaria Initiative and other efforts that have long been in place on the continent. “We actually have launched through USAID and the Centre for Disease Control, a programme that we’re calling Global VAX,” added Goodman. “The effort behind Global Vax is all about the uptake issues. How do we turn vaccines into vaccinations? How do we connect the dots to make sure that we are getting these vaccines distributed in a way that allows more people to have the opportunity to take the vaccine and that allows some of these countries which are lagging to meet the 70% target?” Blinken’s six-point ‘GAP’ plan Ghanian health worker Evelyn Narkie Dowuona holds up her COVID-19 vaccination card. Blinken presented a six-point COVID-19 Prioritized Global Action Plan for Enhanced Engagement (GAP) to foreign ministers and senior leaders from countries and international organizations invited to his virtual meeting. “Together, we identified urgent gaps in response activities and aligned around specific roles to advance global efforts aimed at bringing this pandemic under control and strengthening readiness for future global health threats. We agreed that more political leadership is needed to save lives and end this pandemic cycle in 2022,” said Blinken in a statement issued late Monday. He identified the “six lines of the global effort to respond to acute pandemic needs” as: Getting Shots in Arms: coordinated efforts to improve vaccine readiness and logistics, in step with increased donations and procurement, toward the goal of at least 70% of the population fully vaccinated with quality, safe, and effective vaccines by September 2022. Bolstering Supply Chain Resilience: mechanisms to facilitate sufficient and steady supplies of critical products and materials to break this cycle of the COVID-19 pandemic, including establishing mechanisms to identify and remove medical supply chain bottlenecks. Addressing Information Gaps: global efforts to enhance vaccine confidence and combat the spread of false information, enlisting regional champions and medical, civil society, young people, and faith leaders to use evidence-based, accurate, locally relevant messaging. Supporting Health Workers: protecting the health, safety, and wellbeing of frontline health workers, including the need to improve their training and numbers to effectively support the COVID-19 response. Ensuring Acute Non-Vaccine Interventions, including the provision of therapeutics, testing regimes, and oxygen where needed most. Strengthening Global Health Security Architecture to end the current pandemic and. secure future preparedness for health emergencies at the national, regional and global level. Blinken also announced a direct donation of 5 million doses of Johnson & Johnson’s COVID-19 vaccine to the African Vaccine Acquisition Trust (AVAT), the African Union’s vaccine procurement and distribution effort. The US has now donated more than 155 million doses to Africa and 435 million doses worldwide. Praise for Uganda vaccine effort Ugandan Health Minister Dr Jane Ruth Aceng (left) and French Ambassador to Uganda Jules-Armand Aniambossou with donated AstraZeneca COVID-19 vaccines. In his address to the GAP meeting, Blinken praised Uganda for its massive vaccination effort in November and December last year as an example of what is possible. “In early November, only 14% of all Ugandan adults had received their first dose of the vaccine,” said Blinken. “Then a major team effort commenced. The Ugandan government led a mass vaccination campaign, carried out by hundreds of health care workers,” he added, and “by late December, almost half of all adults in Uganda had received their first shot – from 14 to 47% in just six weeks”. Participants in the GAP meeting included Australia, Canada, Colombia, France, Germany, India, Indonesia, Italy, Japan, the Republic of Korea, New Zealand, Saudi Arabia, Senegal, South Africa,Spain, UK, the African Union/Africa Centres for Disease Control, the European Commission, and the WHO. They have all committed to coordinating parts of the six key areas identified. Meanwhile, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the meeting that “in some countries, high vaccine coverage, combined with the lower severity of Omicron, is driving a false narrative that the pandemic is over”. However, the low vaccine coverage and low testing rates in other countries “are creating the ideal conditions for new variants to emerge”, warned Tedros, adding that 116 countries are off track to vaccinate 70% of the population by the middle of this year. “We can bring the pandemic under control this year – but we are at increased risk of squandering that opportunity,” said Tedros, adding that “in many countries, the issues are not primarily a problem of absorptive capacity. We need to urgently support political leaders to accelerate the rollout of vaccines”. Image Credits: WHO, Health Journalist Network. Malnourished Afghan Children in The Grasp of Measles Outbreak 15/02/2022 Shadi Khan A mother and her child in the Haji camp for internally displaced people in Kandahar, Afghanistan. More and more children are losing their lives to a measles outbreak in Afghanistan as the country struggles with a humanitarian crisis under the US sanctions on the country’s Taliban regime. Following the Taliban’s takeover of Afghanistan, the US Department of the Treasury froze Afghanistan Central Bank’s reserves, mostly held in US banks, as the Taliban has been on its “specially designated global terrorist group” since 2002, and any support for the group is illegal. The measles outbreak has hit the malnourished children hard in some of the already marginalized and poor communities in Paktika, Ghor, Badakhshan and other provinces of Afghanistan. The World Health Organization (WHO) last week confirmed that the number of cases and deaths increased by 18% in the week of 24 January, and 40% in the week of 31 January. Health Policy Watch reported last week that WHO Director-General Dr Tedros Adhanom Ghebreyesus met with the Taliban in Geneva to discuss Afghanistan’s health challenges. Struggle for meals in the pandemic According to the global health body, as many as 35,319 suspected cases of measles and 156 deaths have been reported in Afghanistan between 1 January 2021 and 29 January 2022. Of these, 3,221 cases were laboratory confirmed while 91% of these cases and 97% of these deaths were in children under five years of age. The WHO says that the rise in measles cases is especially concerning because of the extremely high levels of malnutrition in Afghanistan. This weakens immunity, making people more vulnerable to illness and death from diseases like measles – especially children. Local civil society activist in Paktika, Abdul Bari, mentioned that with the fall of the previous government, thousands of people lost their jobs and could not support families for months now that ultimately led to malnourishment and spread of the diseases. “Many families who were doing relatively well in the past now find them among the so many very poor in the society that struggle to feed one or two meals in Paktika”, he said. Mirwais Hospital, Kandahar – The hunger and poverty is more visible than ever in Afghanistan especially on the faces of the youngest victims of the crisis. Hospitals and healthcare facilities are filling up with babies and children suffering from malnutrition pic.twitter.com/J8B6VyEocS — Yalda Hakim (@SkyYaldaHakim) November 29, 2021 Authorities in Badakhshan province told the Health Policy Watch about an outbreak of measles worst affecting the remote Kuf Ab and Kohistan districts of the province where poverty is widespread. “The measles outbreak has been spreading in the province for the past two months and has spread to ten districts, including the capital Faiz Abad”, he said, adding that so far no organization or health institution has come to their aid and many children have died due to the disease in Kuf Ab and Kohistan districts. Equally remote and poor, Ghor province in the central highlands of Afghanistan is the second flashpoint for the measles outbreak according to the Afghan authorities. The provincial health department head, Mohammad Nazim, told the Health Policy Watch that more than a thousand children have been referred to the province’s central hospital recently and 21 of whom have died because of measles. “The reason for the spread of measles is the non-implementation of the vaccination program firstly due to the coronavirus pandemic and then the security concerns and lack of funds”, he said. Crumbling Healthcare System In December 2021, a measles outbreak response immunisation campaign was carried out with the support of the WHO in some of the most affected provinces, reaching 1.5 million children. Battling for survival, Afghanistan’s fragile health system has been on the edge for months in the wake of the COVID-19 pandemic, the Taliban takeover of power and the subsequent US freezing of Afghanistan’s state reserves. In Ghor, the regional public hospital sources said the doctors and support staff is so overstretched and under-paid that it can collapse any moment in the wake of mounting cases of COVID-19 and now the measles outbreak. Kabul-based paediatrician Dr Zar Wali told the Health Policy Watch that malnutrition among children was severely compromising their immune system. “On a daily basis I am receiving dozens of child patients from the city (Kabul) as well as the nearby provinces, and there is this clear pattern of malnourishment in almost all, which makes them susceptible to all sorts of diseases”. This was echoed by the UN Children Fund (UNICEF) last week when it warned that as the humanitarian crisis deepens in Afghanistan, hospitals were receiving so many cases each day of children suffering complications associated with severe acute malnutrition. After relatively low transmission in 2019 and 2020, new infection cases have been increasing in all provinces since the end of July 2021, with the highest weekly toll observed so far occurring over the last four weeks. The WHO has warned that although the number of deaths is relatively low, the rapid rise in cases in January 2022 suggests that the number of deaths due to measles is likely to increase sharply in the coming weeks. Being endemic in Afghanistan, more than 25,000 children get killed by the measles virus annually, according to the Ministry of Public Health, and many more struggle with its impacts. The WHO has expressed willingness to prepare a plan for a larger measles outbreak response immunisation campaign, which will start in May (or earlier, if possible), aiming to reach more than 3 million children in Afghanistan. Image Credits: © UNICEF Afghanistan. African Medicines Agency Host Country Could be Selected by July 15/02/2022 Kerry Cullinan Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD The African Union could decide on the host country for the African Medicines Agency (AMA) as early as July, while the agency’s director-general should be appointed by the end of the year. This is according to Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD, the African Union’s development agency. The AU Assembly had recently decided to “do an assessment of the countries that have offered to host the AMA headquarters”, she told a workshop convened by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on Monday ahead of the EU-AU Summit which starts in Brussels on Thursday. “The AU Commission and AUDA-NEPAD are working together, and the teams are set to go out in the first week of March,” said Ndomondo-Sigonda, adding that the country visits may take two months to complete. “Once they are done, then the assessment report will be presented before the first meeting of the Conference of the State Parties that is planned to be held sometime in May,” she added. Whatever decision is made by this body would have to go to the AU Assembly during its meeting in in June or July, “so by July we will know which countries actually hosting the headquarters for the African Medicines Agency,” she added. The Assembly comprises of all Member State Heads of State and Government is the AU’s supreme policy and decision-making organ. Director-General may be appointed by year-end As far as the appointment of the head of the AMA – its director general – is concerned, this would take a little longer. First, the Conference of the State Parties would have to consider the terms of reference for the position at its May meeting, and advertisements will only go out after that. “By the time we get to know who has been appointed as the director-general, it will probably be quarter three or quarter four this year,” she said. She added that AMA was being established as “a specialised agency of the African Union with its autonomy in terms of financial and human resources, so it’s going to be operating differently from what you see with Africa Centres for Disease Control at the moment”. Meanwhile, UNAIDS Executive Director Winnie Byanyima welcomed the imminent establishment of the AMA. “Since the very beginning of the COVID crisis, the multilateral response may have failed us but African leadership has been remarkable,” said Byanyima at a workshop on Monday. “The newly created African Medicines Agency will harmonise medicine regulations, and negotiate joint purchasing and the manufacture of our own medicines.” European and African Pharma Sector Want Permanent Platform to Support African Development 14/02/2022 Kerry Cullinan A staff member at Afrigen, the mRNA hub in South Africa, prepares part of the vaccine. The major players in the European and African pharmaceutical sectors have called on the European Union (EU) and the African Union (AU) to support the creation of a permanent “business platform” to foster the pharma industry’s development in Africa. This emerged at a workshop Monday hosted by the the European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) along with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and other European-based pharma associations. The workshop was part of the European African Business Forum (EABF) taking place ahead of, and along with, the European Union–African Union Summit, which begins Thursday in Brussels. The business platform should support the development of EU and AU policies conducive to trade and “sustainable financing mechanisms models with access to low-interest capital” and appropriate incentives to encourage local, regional and international private sector investment, according to IFPMA Assistant Director-General Greg Perry, speaking at the Monday EABF session leading up to the Summit. Businesses also want a “stable business environment that respects business ethics and incentivises local innovation and entrepreneurship, including through intellectual property, ensure development and retention of local skilled workforces”, said Perry, reading from a joint statement by the EABF’s Healthcare Working Group, which also includes the European Federation of Pharmaceutical Manufacturers and Associations (EPFIA) and Vaccines Europe. The pharmaceutical sector also wants voluntary and mutually agreed upon technology transfers and joint ventures; timely product registration, harmonisation of regulation particularly through the African Medicines Agency, and the implementation of the African Continental Free Trade Area to eliminate non-trade barriers and foster international supply chain security. “We believe that creating this platform with the support of the EU and the AU, we could facilitate African and European partnerships, support existing continental and regulatory initiatives and create a win-win for both Africa and Europe,” said Perry. Where is the money that was promised? Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee Emmanuel Mujuru, representing the Federation of African Pharmaceutical Manufacturers (FAPMA), said that the African pharmaceutical industry was struggling to access affordable financing. “This financing has to both long-term in nature and have affordable interest rates, either in the form of loans or equity participation in already established African pharma management companies,” said Mujuru. He added that there was a significant opportunity for European investors as between 70 and 90% of essential medicines consumed in Africa were imported and that the pharmaceutical sector was growing at over 10% per annum, second only to Asia. Merck’s Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee, said that while setting up fill and finish operations “is easy to implement in two years”, he had tried to do so in three different African countries but “local private sector investors have never been able to get access to any finance”. “Why? The International Finance Corporation has announced $4 billion for the local vaccine manufacturing and the European Commission has announced one billion Euros,” asked Bendhaou “We also have to invest in the health system capacity because otherwise, you can have a nice factory in in South Africa, a beautiful factory in Egypt, producing hundreds of millions of doses but if you don’t have a health system in place for the uptake and to absorb this capacity,” he added. What about Gavi subsidies? Biovac CEO Patrick Tippoo Meanwhile, Patrick Tippoo, CEO of the South African company, Biovac and part of the African Vaccine Manufacturing Initiative (AVMI) leadership, said that much of Africa’s vaccine supply “comes in a subsidised form, partially or completely by Gavi through UNICEF”. “We know that Gavi drives prices down to make vaccines more affordable so more vaccines can be purchased and therefore distributed,” said Tippoo “We have a current situation where about 40 of the 54 countries depend on this mechanism. And therefore the market in Africa is actually in Copenhagen, as some people say. “This is a structural thing that will have to be addressed because, in order to stimulate and incentivize technology transfers, investment in skills, development, regulatory capacity building – and all the things that we repeat ad nauseum – there needs to be an assurance that there’s going to be a market when all of this is built,” he stressed. Tippoo added that African governments and other stakeholders had to understand that a “resilience premium” would need to be paid to ensure that pharmaceutical manufacturing capability is built in Africa. “There is no way in which vaccines coming out of Africa in the next five or 10 years can compete on a cost of goods perspective, with Indian manufacturer factories, or even multinationals because they’ve monetised the investment over time, and they have economies of scale,” he added. Diversification a ‘win-win’ for Africa, Europe and globally However, other participants pointed out that over the long-term, diversification of sources for pharma procurement is going to be a win win, given the comparatively limited number of suppliers, for some key global health products. Interruptions to key medical supply chains were particularly evident during the early stages of the COVID pandemic, exposing their fragility, even for more affluent countries. Sibilia Quilici, Executive Director, Vaccines Europe, pointed out that from the European perspective, too, it would be beneficial to reduce dependence on what is now a comparatively small number of suppliers, mainly from India and China, and integrate Africa’s supply chains with global ones: “In the context of this discussion on improving manufacturing capacities in Africa, also for APIs [active pharmaceutical ingredients] it is good to be aware that the EU, the largest API importer in the world is looking for supply chain diversification for products where dependence on a small number of suppliers from India and China is a concern. “This could be a win-win for Africa, EU, local and global industry”. Image Credits: Rodger Bosch for MPP/WHO, WHO . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
US and Africa Plan to Harness PEPFAR Networks to Increase COVID Vaccine Uptake 15/02/2022 Kerry Cullinan US Secretary of State Antony Blinken CAPE TOWN – The US and Africa intend to use the well-established community networks supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) to improve the uptake of COVID-19 vaccines in Africa. The initaitive would build upon the infrastructure developed since PEPFAR entered as a major player on the African AIDS scene in 2003. In addition, USAID has launched an initiative called Global VAX to support the World Health Organization (WHO) target of vaccinating 70% of the world’s population by mid-year against COVID-19, and will soon be announcing priority countries in Africa. This is according to US State official Mary Beth Goodman, who briefed African journalists on Tuesday on the COVID-19 Global Action Meeting convened by US Secretary of State Antony Blinken on Monday. “We’re leveraging opportunities through things like PEPFAR, which has an extraordinary network across the African continent in combating HIV/AIDS and has a network of community workers and leaders who are helping to work with us to also talk about some of the importance of COVID,” said Goodman, who is Acting Coordinator for Global COVID-19 Response and Health Security at the US Department of State. “The same is true of our Presidential Malaria Initiative and other efforts that have long been in place on the continent. “We actually have launched through USAID and the Centre for Disease Control, a programme that we’re calling Global VAX,” added Goodman. “The effort behind Global Vax is all about the uptake issues. How do we turn vaccines into vaccinations? How do we connect the dots to make sure that we are getting these vaccines distributed in a way that allows more people to have the opportunity to take the vaccine and that allows some of these countries which are lagging to meet the 70% target?” Blinken’s six-point ‘GAP’ plan Ghanian health worker Evelyn Narkie Dowuona holds up her COVID-19 vaccination card. Blinken presented a six-point COVID-19 Prioritized Global Action Plan for Enhanced Engagement (GAP) to foreign ministers and senior leaders from countries and international organizations invited to his virtual meeting. “Together, we identified urgent gaps in response activities and aligned around specific roles to advance global efforts aimed at bringing this pandemic under control and strengthening readiness for future global health threats. We agreed that more political leadership is needed to save lives and end this pandemic cycle in 2022,” said Blinken in a statement issued late Monday. He identified the “six lines of the global effort to respond to acute pandemic needs” as: Getting Shots in Arms: coordinated efforts to improve vaccine readiness and logistics, in step with increased donations and procurement, toward the goal of at least 70% of the population fully vaccinated with quality, safe, and effective vaccines by September 2022. Bolstering Supply Chain Resilience: mechanisms to facilitate sufficient and steady supplies of critical products and materials to break this cycle of the COVID-19 pandemic, including establishing mechanisms to identify and remove medical supply chain bottlenecks. Addressing Information Gaps: global efforts to enhance vaccine confidence and combat the spread of false information, enlisting regional champions and medical, civil society, young people, and faith leaders to use evidence-based, accurate, locally relevant messaging. Supporting Health Workers: protecting the health, safety, and wellbeing of frontline health workers, including the need to improve their training and numbers to effectively support the COVID-19 response. Ensuring Acute Non-Vaccine Interventions, including the provision of therapeutics, testing regimes, and oxygen where needed most. Strengthening Global Health Security Architecture to end the current pandemic and. secure future preparedness for health emergencies at the national, regional and global level. Blinken also announced a direct donation of 5 million doses of Johnson & Johnson’s COVID-19 vaccine to the African Vaccine Acquisition Trust (AVAT), the African Union’s vaccine procurement and distribution effort. The US has now donated more than 155 million doses to Africa and 435 million doses worldwide. Praise for Uganda vaccine effort Ugandan Health Minister Dr Jane Ruth Aceng (left) and French Ambassador to Uganda Jules-Armand Aniambossou with donated AstraZeneca COVID-19 vaccines. In his address to the GAP meeting, Blinken praised Uganda for its massive vaccination effort in November and December last year as an example of what is possible. “In early November, only 14% of all Ugandan adults had received their first dose of the vaccine,” said Blinken. “Then a major team effort commenced. The Ugandan government led a mass vaccination campaign, carried out by hundreds of health care workers,” he added, and “by late December, almost half of all adults in Uganda had received their first shot – from 14 to 47% in just six weeks”. Participants in the GAP meeting included Australia, Canada, Colombia, France, Germany, India, Indonesia, Italy, Japan, the Republic of Korea, New Zealand, Saudi Arabia, Senegal, South Africa,Spain, UK, the African Union/Africa Centres for Disease Control, the European Commission, and the WHO. They have all committed to coordinating parts of the six key areas identified. Meanwhile, WHO Director-General Dr Tedros Adhanom Ghebreyesus told the meeting that “in some countries, high vaccine coverage, combined with the lower severity of Omicron, is driving a false narrative that the pandemic is over”. However, the low vaccine coverage and low testing rates in other countries “are creating the ideal conditions for new variants to emerge”, warned Tedros, adding that 116 countries are off track to vaccinate 70% of the population by the middle of this year. “We can bring the pandemic under control this year – but we are at increased risk of squandering that opportunity,” said Tedros, adding that “in many countries, the issues are not primarily a problem of absorptive capacity. We need to urgently support political leaders to accelerate the rollout of vaccines”. Image Credits: WHO, Health Journalist Network. Malnourished Afghan Children in The Grasp of Measles Outbreak 15/02/2022 Shadi Khan A mother and her child in the Haji camp for internally displaced people in Kandahar, Afghanistan. More and more children are losing their lives to a measles outbreak in Afghanistan as the country struggles with a humanitarian crisis under the US sanctions on the country’s Taliban regime. Following the Taliban’s takeover of Afghanistan, the US Department of the Treasury froze Afghanistan Central Bank’s reserves, mostly held in US banks, as the Taliban has been on its “specially designated global terrorist group” since 2002, and any support for the group is illegal. The measles outbreak has hit the malnourished children hard in some of the already marginalized and poor communities in Paktika, Ghor, Badakhshan and other provinces of Afghanistan. The World Health Organization (WHO) last week confirmed that the number of cases and deaths increased by 18% in the week of 24 January, and 40% in the week of 31 January. Health Policy Watch reported last week that WHO Director-General Dr Tedros Adhanom Ghebreyesus met with the Taliban in Geneva to discuss Afghanistan’s health challenges. Struggle for meals in the pandemic According to the global health body, as many as 35,319 suspected cases of measles and 156 deaths have been reported in Afghanistan between 1 January 2021 and 29 January 2022. Of these, 3,221 cases were laboratory confirmed while 91% of these cases and 97% of these deaths were in children under five years of age. The WHO says that the rise in measles cases is especially concerning because of the extremely high levels of malnutrition in Afghanistan. This weakens immunity, making people more vulnerable to illness and death from diseases like measles – especially children. Local civil society activist in Paktika, Abdul Bari, mentioned that with the fall of the previous government, thousands of people lost their jobs and could not support families for months now that ultimately led to malnourishment and spread of the diseases. “Many families who were doing relatively well in the past now find them among the so many very poor in the society that struggle to feed one or two meals in Paktika”, he said. Mirwais Hospital, Kandahar – The hunger and poverty is more visible than ever in Afghanistan especially on the faces of the youngest victims of the crisis. Hospitals and healthcare facilities are filling up with babies and children suffering from malnutrition pic.twitter.com/J8B6VyEocS — Yalda Hakim (@SkyYaldaHakim) November 29, 2021 Authorities in Badakhshan province told the Health Policy Watch about an outbreak of measles worst affecting the remote Kuf Ab and Kohistan districts of the province where poverty is widespread. “The measles outbreak has been spreading in the province for the past two months and has spread to ten districts, including the capital Faiz Abad”, he said, adding that so far no organization or health institution has come to their aid and many children have died due to the disease in Kuf Ab and Kohistan districts. Equally remote and poor, Ghor province in the central highlands of Afghanistan is the second flashpoint for the measles outbreak according to the Afghan authorities. The provincial health department head, Mohammad Nazim, told the Health Policy Watch that more than a thousand children have been referred to the province’s central hospital recently and 21 of whom have died because of measles. “The reason for the spread of measles is the non-implementation of the vaccination program firstly due to the coronavirus pandemic and then the security concerns and lack of funds”, he said. Crumbling Healthcare System In December 2021, a measles outbreak response immunisation campaign was carried out with the support of the WHO in some of the most affected provinces, reaching 1.5 million children. Battling for survival, Afghanistan’s fragile health system has been on the edge for months in the wake of the COVID-19 pandemic, the Taliban takeover of power and the subsequent US freezing of Afghanistan’s state reserves. In Ghor, the regional public hospital sources said the doctors and support staff is so overstretched and under-paid that it can collapse any moment in the wake of mounting cases of COVID-19 and now the measles outbreak. Kabul-based paediatrician Dr Zar Wali told the Health Policy Watch that malnutrition among children was severely compromising their immune system. “On a daily basis I am receiving dozens of child patients from the city (Kabul) as well as the nearby provinces, and there is this clear pattern of malnourishment in almost all, which makes them susceptible to all sorts of diseases”. This was echoed by the UN Children Fund (UNICEF) last week when it warned that as the humanitarian crisis deepens in Afghanistan, hospitals were receiving so many cases each day of children suffering complications associated with severe acute malnutrition. After relatively low transmission in 2019 and 2020, new infection cases have been increasing in all provinces since the end of July 2021, with the highest weekly toll observed so far occurring over the last four weeks. The WHO has warned that although the number of deaths is relatively low, the rapid rise in cases in January 2022 suggests that the number of deaths due to measles is likely to increase sharply in the coming weeks. Being endemic in Afghanistan, more than 25,000 children get killed by the measles virus annually, according to the Ministry of Public Health, and many more struggle with its impacts. The WHO has expressed willingness to prepare a plan for a larger measles outbreak response immunisation campaign, which will start in May (or earlier, if possible), aiming to reach more than 3 million children in Afghanistan. Image Credits: © UNICEF Afghanistan. African Medicines Agency Host Country Could be Selected by July 15/02/2022 Kerry Cullinan Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD The African Union could decide on the host country for the African Medicines Agency (AMA) as early as July, while the agency’s director-general should be appointed by the end of the year. This is according to Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD, the African Union’s development agency. The AU Assembly had recently decided to “do an assessment of the countries that have offered to host the AMA headquarters”, she told a workshop convened by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on Monday ahead of the EU-AU Summit which starts in Brussels on Thursday. “The AU Commission and AUDA-NEPAD are working together, and the teams are set to go out in the first week of March,” said Ndomondo-Sigonda, adding that the country visits may take two months to complete. “Once they are done, then the assessment report will be presented before the first meeting of the Conference of the State Parties that is planned to be held sometime in May,” she added. Whatever decision is made by this body would have to go to the AU Assembly during its meeting in in June or July, “so by July we will know which countries actually hosting the headquarters for the African Medicines Agency,” she added. The Assembly comprises of all Member State Heads of State and Government is the AU’s supreme policy and decision-making organ. Director-General may be appointed by year-end As far as the appointment of the head of the AMA – its director general – is concerned, this would take a little longer. First, the Conference of the State Parties would have to consider the terms of reference for the position at its May meeting, and advertisements will only go out after that. “By the time we get to know who has been appointed as the director-general, it will probably be quarter three or quarter four this year,” she said. She added that AMA was being established as “a specialised agency of the African Union with its autonomy in terms of financial and human resources, so it’s going to be operating differently from what you see with Africa Centres for Disease Control at the moment”. Meanwhile, UNAIDS Executive Director Winnie Byanyima welcomed the imminent establishment of the AMA. “Since the very beginning of the COVID crisis, the multilateral response may have failed us but African leadership has been remarkable,” said Byanyima at a workshop on Monday. “The newly created African Medicines Agency will harmonise medicine regulations, and negotiate joint purchasing and the manufacture of our own medicines.” European and African Pharma Sector Want Permanent Platform to Support African Development 14/02/2022 Kerry Cullinan A staff member at Afrigen, the mRNA hub in South Africa, prepares part of the vaccine. The major players in the European and African pharmaceutical sectors have called on the European Union (EU) and the African Union (AU) to support the creation of a permanent “business platform” to foster the pharma industry’s development in Africa. This emerged at a workshop Monday hosted by the the European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) along with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and other European-based pharma associations. The workshop was part of the European African Business Forum (EABF) taking place ahead of, and along with, the European Union–African Union Summit, which begins Thursday in Brussels. The business platform should support the development of EU and AU policies conducive to trade and “sustainable financing mechanisms models with access to low-interest capital” and appropriate incentives to encourage local, regional and international private sector investment, according to IFPMA Assistant Director-General Greg Perry, speaking at the Monday EABF session leading up to the Summit. Businesses also want a “stable business environment that respects business ethics and incentivises local innovation and entrepreneurship, including through intellectual property, ensure development and retention of local skilled workforces”, said Perry, reading from a joint statement by the EABF’s Healthcare Working Group, which also includes the European Federation of Pharmaceutical Manufacturers and Associations (EPFIA) and Vaccines Europe. The pharmaceutical sector also wants voluntary and mutually agreed upon technology transfers and joint ventures; timely product registration, harmonisation of regulation particularly through the African Medicines Agency, and the implementation of the African Continental Free Trade Area to eliminate non-trade barriers and foster international supply chain security. “We believe that creating this platform with the support of the EU and the AU, we could facilitate African and European partnerships, support existing continental and regulatory initiatives and create a win-win for both Africa and Europe,” said Perry. Where is the money that was promised? Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee Emmanuel Mujuru, representing the Federation of African Pharmaceutical Manufacturers (FAPMA), said that the African pharmaceutical industry was struggling to access affordable financing. “This financing has to both long-term in nature and have affordable interest rates, either in the form of loans or equity participation in already established African pharma management companies,” said Mujuru. He added that there was a significant opportunity for European investors as between 70 and 90% of essential medicines consumed in Africa were imported and that the pharmaceutical sector was growing at over 10% per annum, second only to Asia. Merck’s Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee, said that while setting up fill and finish operations “is easy to implement in two years”, he had tried to do so in three different African countries but “local private sector investors have never been able to get access to any finance”. “Why? The International Finance Corporation has announced $4 billion for the local vaccine manufacturing and the European Commission has announced one billion Euros,” asked Bendhaou “We also have to invest in the health system capacity because otherwise, you can have a nice factory in in South Africa, a beautiful factory in Egypt, producing hundreds of millions of doses but if you don’t have a health system in place for the uptake and to absorb this capacity,” he added. What about Gavi subsidies? Biovac CEO Patrick Tippoo Meanwhile, Patrick Tippoo, CEO of the South African company, Biovac and part of the African Vaccine Manufacturing Initiative (AVMI) leadership, said that much of Africa’s vaccine supply “comes in a subsidised form, partially or completely by Gavi through UNICEF”. “We know that Gavi drives prices down to make vaccines more affordable so more vaccines can be purchased and therefore distributed,” said Tippoo “We have a current situation where about 40 of the 54 countries depend on this mechanism. And therefore the market in Africa is actually in Copenhagen, as some people say. “This is a structural thing that will have to be addressed because, in order to stimulate and incentivize technology transfers, investment in skills, development, regulatory capacity building – and all the things that we repeat ad nauseum – there needs to be an assurance that there’s going to be a market when all of this is built,” he stressed. Tippoo added that African governments and other stakeholders had to understand that a “resilience premium” would need to be paid to ensure that pharmaceutical manufacturing capability is built in Africa. “There is no way in which vaccines coming out of Africa in the next five or 10 years can compete on a cost of goods perspective, with Indian manufacturer factories, or even multinationals because they’ve monetised the investment over time, and they have economies of scale,” he added. Diversification a ‘win-win’ for Africa, Europe and globally However, other participants pointed out that over the long-term, diversification of sources for pharma procurement is going to be a win win, given the comparatively limited number of suppliers, for some key global health products. Interruptions to key medical supply chains were particularly evident during the early stages of the COVID pandemic, exposing their fragility, even for more affluent countries. Sibilia Quilici, Executive Director, Vaccines Europe, pointed out that from the European perspective, too, it would be beneficial to reduce dependence on what is now a comparatively small number of suppliers, mainly from India and China, and integrate Africa’s supply chains with global ones: “In the context of this discussion on improving manufacturing capacities in Africa, also for APIs [active pharmaceutical ingredients] it is good to be aware that the EU, the largest API importer in the world is looking for supply chain diversification for products where dependence on a small number of suppliers from India and China is a concern. “This could be a win-win for Africa, EU, local and global industry”. Image Credits: Rodger Bosch for MPP/WHO, WHO . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Malnourished Afghan Children in The Grasp of Measles Outbreak 15/02/2022 Shadi Khan A mother and her child in the Haji camp for internally displaced people in Kandahar, Afghanistan. More and more children are losing their lives to a measles outbreak in Afghanistan as the country struggles with a humanitarian crisis under the US sanctions on the country’s Taliban regime. Following the Taliban’s takeover of Afghanistan, the US Department of the Treasury froze Afghanistan Central Bank’s reserves, mostly held in US banks, as the Taliban has been on its “specially designated global terrorist group” since 2002, and any support for the group is illegal. The measles outbreak has hit the malnourished children hard in some of the already marginalized and poor communities in Paktika, Ghor, Badakhshan and other provinces of Afghanistan. The World Health Organization (WHO) last week confirmed that the number of cases and deaths increased by 18% in the week of 24 January, and 40% in the week of 31 January. Health Policy Watch reported last week that WHO Director-General Dr Tedros Adhanom Ghebreyesus met with the Taliban in Geneva to discuss Afghanistan’s health challenges. Struggle for meals in the pandemic According to the global health body, as many as 35,319 suspected cases of measles and 156 deaths have been reported in Afghanistan between 1 January 2021 and 29 January 2022. Of these, 3,221 cases were laboratory confirmed while 91% of these cases and 97% of these deaths were in children under five years of age. The WHO says that the rise in measles cases is especially concerning because of the extremely high levels of malnutrition in Afghanistan. This weakens immunity, making people more vulnerable to illness and death from diseases like measles – especially children. Local civil society activist in Paktika, Abdul Bari, mentioned that with the fall of the previous government, thousands of people lost their jobs and could not support families for months now that ultimately led to malnourishment and spread of the diseases. “Many families who were doing relatively well in the past now find them among the so many very poor in the society that struggle to feed one or two meals in Paktika”, he said. Mirwais Hospital, Kandahar – The hunger and poverty is more visible than ever in Afghanistan especially on the faces of the youngest victims of the crisis. Hospitals and healthcare facilities are filling up with babies and children suffering from malnutrition pic.twitter.com/J8B6VyEocS — Yalda Hakim (@SkyYaldaHakim) November 29, 2021 Authorities in Badakhshan province told the Health Policy Watch about an outbreak of measles worst affecting the remote Kuf Ab and Kohistan districts of the province where poverty is widespread. “The measles outbreak has been spreading in the province for the past two months and has spread to ten districts, including the capital Faiz Abad”, he said, adding that so far no organization or health institution has come to their aid and many children have died due to the disease in Kuf Ab and Kohistan districts. Equally remote and poor, Ghor province in the central highlands of Afghanistan is the second flashpoint for the measles outbreak according to the Afghan authorities. The provincial health department head, Mohammad Nazim, told the Health Policy Watch that more than a thousand children have been referred to the province’s central hospital recently and 21 of whom have died because of measles. “The reason for the spread of measles is the non-implementation of the vaccination program firstly due to the coronavirus pandemic and then the security concerns and lack of funds”, he said. Crumbling Healthcare System In December 2021, a measles outbreak response immunisation campaign was carried out with the support of the WHO in some of the most affected provinces, reaching 1.5 million children. Battling for survival, Afghanistan’s fragile health system has been on the edge for months in the wake of the COVID-19 pandemic, the Taliban takeover of power and the subsequent US freezing of Afghanistan’s state reserves. In Ghor, the regional public hospital sources said the doctors and support staff is so overstretched and under-paid that it can collapse any moment in the wake of mounting cases of COVID-19 and now the measles outbreak. Kabul-based paediatrician Dr Zar Wali told the Health Policy Watch that malnutrition among children was severely compromising their immune system. “On a daily basis I am receiving dozens of child patients from the city (Kabul) as well as the nearby provinces, and there is this clear pattern of malnourishment in almost all, which makes them susceptible to all sorts of diseases”. This was echoed by the UN Children Fund (UNICEF) last week when it warned that as the humanitarian crisis deepens in Afghanistan, hospitals were receiving so many cases each day of children suffering complications associated with severe acute malnutrition. After relatively low transmission in 2019 and 2020, new infection cases have been increasing in all provinces since the end of July 2021, with the highest weekly toll observed so far occurring over the last four weeks. The WHO has warned that although the number of deaths is relatively low, the rapid rise in cases in January 2022 suggests that the number of deaths due to measles is likely to increase sharply in the coming weeks. Being endemic in Afghanistan, more than 25,000 children get killed by the measles virus annually, according to the Ministry of Public Health, and many more struggle with its impacts. The WHO has expressed willingness to prepare a plan for a larger measles outbreak response immunisation campaign, which will start in May (or earlier, if possible), aiming to reach more than 3 million children in Afghanistan. Image Credits: © UNICEF Afghanistan. African Medicines Agency Host Country Could be Selected by July 15/02/2022 Kerry Cullinan Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD The African Union could decide on the host country for the African Medicines Agency (AMA) as early as July, while the agency’s director-general should be appointed by the end of the year. This is according to Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD, the African Union’s development agency. The AU Assembly had recently decided to “do an assessment of the countries that have offered to host the AMA headquarters”, she told a workshop convened by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on Monday ahead of the EU-AU Summit which starts in Brussels on Thursday. “The AU Commission and AUDA-NEPAD are working together, and the teams are set to go out in the first week of March,” said Ndomondo-Sigonda, adding that the country visits may take two months to complete. “Once they are done, then the assessment report will be presented before the first meeting of the Conference of the State Parties that is planned to be held sometime in May,” she added. Whatever decision is made by this body would have to go to the AU Assembly during its meeting in in June or July, “so by July we will know which countries actually hosting the headquarters for the African Medicines Agency,” she added. The Assembly comprises of all Member State Heads of State and Government is the AU’s supreme policy and decision-making organ. Director-General may be appointed by year-end As far as the appointment of the head of the AMA – its director general – is concerned, this would take a little longer. First, the Conference of the State Parties would have to consider the terms of reference for the position at its May meeting, and advertisements will only go out after that. “By the time we get to know who has been appointed as the director-general, it will probably be quarter three or quarter four this year,” she said. She added that AMA was being established as “a specialised agency of the African Union with its autonomy in terms of financial and human resources, so it’s going to be operating differently from what you see with Africa Centres for Disease Control at the moment”. Meanwhile, UNAIDS Executive Director Winnie Byanyima welcomed the imminent establishment of the AMA. “Since the very beginning of the COVID crisis, the multilateral response may have failed us but African leadership has been remarkable,” said Byanyima at a workshop on Monday. “The newly created African Medicines Agency will harmonise medicine regulations, and negotiate joint purchasing and the manufacture of our own medicines.” European and African Pharma Sector Want Permanent Platform to Support African Development 14/02/2022 Kerry Cullinan A staff member at Afrigen, the mRNA hub in South Africa, prepares part of the vaccine. The major players in the European and African pharmaceutical sectors have called on the European Union (EU) and the African Union (AU) to support the creation of a permanent “business platform” to foster the pharma industry’s development in Africa. This emerged at a workshop Monday hosted by the the European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) along with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and other European-based pharma associations. The workshop was part of the European African Business Forum (EABF) taking place ahead of, and along with, the European Union–African Union Summit, which begins Thursday in Brussels. The business platform should support the development of EU and AU policies conducive to trade and “sustainable financing mechanisms models with access to low-interest capital” and appropriate incentives to encourage local, regional and international private sector investment, according to IFPMA Assistant Director-General Greg Perry, speaking at the Monday EABF session leading up to the Summit. Businesses also want a “stable business environment that respects business ethics and incentivises local innovation and entrepreneurship, including through intellectual property, ensure development and retention of local skilled workforces”, said Perry, reading from a joint statement by the EABF’s Healthcare Working Group, which also includes the European Federation of Pharmaceutical Manufacturers and Associations (EPFIA) and Vaccines Europe. The pharmaceutical sector also wants voluntary and mutually agreed upon technology transfers and joint ventures; timely product registration, harmonisation of regulation particularly through the African Medicines Agency, and the implementation of the African Continental Free Trade Area to eliminate non-trade barriers and foster international supply chain security. “We believe that creating this platform with the support of the EU and the AU, we could facilitate African and European partnerships, support existing continental and regulatory initiatives and create a win-win for both Africa and Europe,” said Perry. Where is the money that was promised? Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee Emmanuel Mujuru, representing the Federation of African Pharmaceutical Manufacturers (FAPMA), said that the African pharmaceutical industry was struggling to access affordable financing. “This financing has to both long-term in nature and have affordable interest rates, either in the form of loans or equity participation in already established African pharma management companies,” said Mujuru. He added that there was a significant opportunity for European investors as between 70 and 90% of essential medicines consumed in Africa were imported and that the pharmaceutical sector was growing at over 10% per annum, second only to Asia. Merck’s Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee, said that while setting up fill and finish operations “is easy to implement in two years”, he had tried to do so in three different African countries but “local private sector investors have never been able to get access to any finance”. “Why? The International Finance Corporation has announced $4 billion for the local vaccine manufacturing and the European Commission has announced one billion Euros,” asked Bendhaou “We also have to invest in the health system capacity because otherwise, you can have a nice factory in in South Africa, a beautiful factory in Egypt, producing hundreds of millions of doses but if you don’t have a health system in place for the uptake and to absorb this capacity,” he added. What about Gavi subsidies? Biovac CEO Patrick Tippoo Meanwhile, Patrick Tippoo, CEO of the South African company, Biovac and part of the African Vaccine Manufacturing Initiative (AVMI) leadership, said that much of Africa’s vaccine supply “comes in a subsidised form, partially or completely by Gavi through UNICEF”. “We know that Gavi drives prices down to make vaccines more affordable so more vaccines can be purchased and therefore distributed,” said Tippoo “We have a current situation where about 40 of the 54 countries depend on this mechanism. And therefore the market in Africa is actually in Copenhagen, as some people say. “This is a structural thing that will have to be addressed because, in order to stimulate and incentivize technology transfers, investment in skills, development, regulatory capacity building – and all the things that we repeat ad nauseum – there needs to be an assurance that there’s going to be a market when all of this is built,” he stressed. Tippoo added that African governments and other stakeholders had to understand that a “resilience premium” would need to be paid to ensure that pharmaceutical manufacturing capability is built in Africa. “There is no way in which vaccines coming out of Africa in the next five or 10 years can compete on a cost of goods perspective, with Indian manufacturer factories, or even multinationals because they’ve monetised the investment over time, and they have economies of scale,” he added. Diversification a ‘win-win’ for Africa, Europe and globally However, other participants pointed out that over the long-term, diversification of sources for pharma procurement is going to be a win win, given the comparatively limited number of suppliers, for some key global health products. Interruptions to key medical supply chains were particularly evident during the early stages of the COVID pandemic, exposing their fragility, even for more affluent countries. Sibilia Quilici, Executive Director, Vaccines Europe, pointed out that from the European perspective, too, it would be beneficial to reduce dependence on what is now a comparatively small number of suppliers, mainly from India and China, and integrate Africa’s supply chains with global ones: “In the context of this discussion on improving manufacturing capacities in Africa, also for APIs [active pharmaceutical ingredients] it is good to be aware that the EU, the largest API importer in the world is looking for supply chain diversification for products where dependence on a small number of suppliers from India and China is a concern. “This could be a win-win for Africa, EU, local and global industry”. Image Credits: Rodger Bosch for MPP/WHO, WHO . Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. 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African Medicines Agency Host Country Could be Selected by July 15/02/2022 Kerry Cullinan Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD The African Union could decide on the host country for the African Medicines Agency (AMA) as early as July, while the agency’s director-general should be appointed by the end of the year. This is according to Margaret Ndomondo-Sigonda, Head of the African Medicines Regulatory Harmonisation Initiative at AUDA-NEPAD, the African Union’s development agency. The AU Assembly had recently decided to “do an assessment of the countries that have offered to host the AMA headquarters”, she told a workshop convened by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on Monday ahead of the EU-AU Summit which starts in Brussels on Thursday. “The AU Commission and AUDA-NEPAD are working together, and the teams are set to go out in the first week of March,” said Ndomondo-Sigonda, adding that the country visits may take two months to complete. “Once they are done, then the assessment report will be presented before the first meeting of the Conference of the State Parties that is planned to be held sometime in May,” she added. Whatever decision is made by this body would have to go to the AU Assembly during its meeting in in June or July, “so by July we will know which countries actually hosting the headquarters for the African Medicines Agency,” she added. The Assembly comprises of all Member State Heads of State and Government is the AU’s supreme policy and decision-making organ. Director-General may be appointed by year-end As far as the appointment of the head of the AMA – its director general – is concerned, this would take a little longer. First, the Conference of the State Parties would have to consider the terms of reference for the position at its May meeting, and advertisements will only go out after that. “By the time we get to know who has been appointed as the director-general, it will probably be quarter three or quarter four this year,” she said. She added that AMA was being established as “a specialised agency of the African Union with its autonomy in terms of financial and human resources, so it’s going to be operating differently from what you see with Africa Centres for Disease Control at the moment”. Meanwhile, UNAIDS Executive Director Winnie Byanyima welcomed the imminent establishment of the AMA. “Since the very beginning of the COVID crisis, the multilateral response may have failed us but African leadership has been remarkable,” said Byanyima at a workshop on Monday. “The newly created African Medicines Agency will harmonise medicine regulations, and negotiate joint purchasing and the manufacture of our own medicines.” European and African Pharma Sector Want Permanent Platform to Support African Development 14/02/2022 Kerry Cullinan A staff member at Afrigen, the mRNA hub in South Africa, prepares part of the vaccine. The major players in the European and African pharmaceutical sectors have called on the European Union (EU) and the African Union (AU) to support the creation of a permanent “business platform” to foster the pharma industry’s development in Africa. This emerged at a workshop Monday hosted by the the European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) along with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and other European-based pharma associations. The workshop was part of the European African Business Forum (EABF) taking place ahead of, and along with, the European Union–African Union Summit, which begins Thursday in Brussels. The business platform should support the development of EU and AU policies conducive to trade and “sustainable financing mechanisms models with access to low-interest capital” and appropriate incentives to encourage local, regional and international private sector investment, according to IFPMA Assistant Director-General Greg Perry, speaking at the Monday EABF session leading up to the Summit. Businesses also want a “stable business environment that respects business ethics and incentivises local innovation and entrepreneurship, including through intellectual property, ensure development and retention of local skilled workforces”, said Perry, reading from a joint statement by the EABF’s Healthcare Working Group, which also includes the European Federation of Pharmaceutical Manufacturers and Associations (EPFIA) and Vaccines Europe. The pharmaceutical sector also wants voluntary and mutually agreed upon technology transfers and joint ventures; timely product registration, harmonisation of regulation particularly through the African Medicines Agency, and the implementation of the African Continental Free Trade Area to eliminate non-trade barriers and foster international supply chain security. “We believe that creating this platform with the support of the EU and the AU, we could facilitate African and European partnerships, support existing continental and regulatory initiatives and create a win-win for both Africa and Europe,” said Perry. Where is the money that was promised? Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee Emmanuel Mujuru, representing the Federation of African Pharmaceutical Manufacturers (FAPMA), said that the African pharmaceutical industry was struggling to access affordable financing. “This financing has to both long-term in nature and have affordable interest rates, either in the form of loans or equity participation in already established African pharma management companies,” said Mujuru. He added that there was a significant opportunity for European investors as between 70 and 90% of essential medicines consumed in Africa were imported and that the pharmaceutical sector was growing at over 10% per annum, second only to Asia. Merck’s Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee, said that while setting up fill and finish operations “is easy to implement in two years”, he had tried to do so in three different African countries but “local private sector investors have never been able to get access to any finance”. “Why? The International Finance Corporation has announced $4 billion for the local vaccine manufacturing and the European Commission has announced one billion Euros,” asked Bendhaou “We also have to invest in the health system capacity because otherwise, you can have a nice factory in in South Africa, a beautiful factory in Egypt, producing hundreds of millions of doses but if you don’t have a health system in place for the uptake and to absorb this capacity,” he added. What about Gavi subsidies? Biovac CEO Patrick Tippoo Meanwhile, Patrick Tippoo, CEO of the South African company, Biovac and part of the African Vaccine Manufacturing Initiative (AVMI) leadership, said that much of Africa’s vaccine supply “comes in a subsidised form, partially or completely by Gavi through UNICEF”. “We know that Gavi drives prices down to make vaccines more affordable so more vaccines can be purchased and therefore distributed,” said Tippoo “We have a current situation where about 40 of the 54 countries depend on this mechanism. And therefore the market in Africa is actually in Copenhagen, as some people say. “This is a structural thing that will have to be addressed because, in order to stimulate and incentivize technology transfers, investment in skills, development, regulatory capacity building – and all the things that we repeat ad nauseum – there needs to be an assurance that there’s going to be a market when all of this is built,” he stressed. Tippoo added that African governments and other stakeholders had to understand that a “resilience premium” would need to be paid to ensure that pharmaceutical manufacturing capability is built in Africa. “There is no way in which vaccines coming out of Africa in the next five or 10 years can compete on a cost of goods perspective, with Indian manufacturer factories, or even multinationals because they’ve monetised the investment over time, and they have economies of scale,” he added. Diversification a ‘win-win’ for Africa, Europe and globally However, other participants pointed out that over the long-term, diversification of sources for pharma procurement is going to be a win win, given the comparatively limited number of suppliers, for some key global health products. Interruptions to key medical supply chains were particularly evident during the early stages of the COVID pandemic, exposing their fragility, even for more affluent countries. Sibilia Quilici, Executive Director, Vaccines Europe, pointed out that from the European perspective, too, it would be beneficial to reduce dependence on what is now a comparatively small number of suppliers, mainly from India and China, and integrate Africa’s supply chains with global ones: “In the context of this discussion on improving manufacturing capacities in Africa, also for APIs [active pharmaceutical ingredients] it is good to be aware that the EU, the largest API importer in the world is looking for supply chain diversification for products where dependence on a small number of suppliers from India and China is a concern. “This could be a win-win for Africa, EU, local and global industry”. Image Credits: Rodger Bosch for MPP/WHO, WHO . 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
European and African Pharma Sector Want Permanent Platform to Support African Development 14/02/2022 Kerry Cullinan A staff member at Afrigen, the mRNA hub in South Africa, prepares part of the vaccine. The major players in the European and African pharmaceutical sectors have called on the European Union (EU) and the African Union (AU) to support the creation of a permanent “business platform” to foster the pharma industry’s development in Africa. This emerged at a workshop Monday hosted by the the European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) along with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and other European-based pharma associations. The workshop was part of the European African Business Forum (EABF) taking place ahead of, and along with, the European Union–African Union Summit, which begins Thursday in Brussels. The business platform should support the development of EU and AU policies conducive to trade and “sustainable financing mechanisms models with access to low-interest capital” and appropriate incentives to encourage local, regional and international private sector investment, according to IFPMA Assistant Director-General Greg Perry, speaking at the Monday EABF session leading up to the Summit. Businesses also want a “stable business environment that respects business ethics and incentivises local innovation and entrepreneurship, including through intellectual property, ensure development and retention of local skilled workforces”, said Perry, reading from a joint statement by the EABF’s Healthcare Working Group, which also includes the European Federation of Pharmaceutical Manufacturers and Associations (EPFIA) and Vaccines Europe. The pharmaceutical sector also wants voluntary and mutually agreed upon technology transfers and joint ventures; timely product registration, harmonisation of regulation particularly through the African Medicines Agency, and the implementation of the African Continental Free Trade Area to eliminate non-trade barriers and foster international supply chain security. “We believe that creating this platform with the support of the EU and the AU, we could facilitate African and European partnerships, support existing continental and regulatory initiatives and create a win-win for both Africa and Europe,” said Perry. Where is the money that was promised? Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee Emmanuel Mujuru, representing the Federation of African Pharmaceutical Manufacturers (FAPMA), said that the African pharmaceutical industry was struggling to access affordable financing. “This financing has to both long-term in nature and have affordable interest rates, either in the form of loans or equity participation in already established African pharma management companies,” said Mujuru. He added that there was a significant opportunity for European investors as between 70 and 90% of essential medicines consumed in Africa were imported and that the pharmaceutical sector was growing at over 10% per annum, second only to Asia. Merck’s Karim Bendhaou, who also chairs the IFPMA Africa Engagement Committee, said that while setting up fill and finish operations “is easy to implement in two years”, he had tried to do so in three different African countries but “local private sector investors have never been able to get access to any finance”. “Why? The International Finance Corporation has announced $4 billion for the local vaccine manufacturing and the European Commission has announced one billion Euros,” asked Bendhaou “We also have to invest in the health system capacity because otherwise, you can have a nice factory in in South Africa, a beautiful factory in Egypt, producing hundreds of millions of doses but if you don’t have a health system in place for the uptake and to absorb this capacity,” he added. What about Gavi subsidies? Biovac CEO Patrick Tippoo Meanwhile, Patrick Tippoo, CEO of the South African company, Biovac and part of the African Vaccine Manufacturing Initiative (AVMI) leadership, said that much of Africa’s vaccine supply “comes in a subsidised form, partially or completely by Gavi through UNICEF”. “We know that Gavi drives prices down to make vaccines more affordable so more vaccines can be purchased and therefore distributed,” said Tippoo “We have a current situation where about 40 of the 54 countries depend on this mechanism. And therefore the market in Africa is actually in Copenhagen, as some people say. “This is a structural thing that will have to be addressed because, in order to stimulate and incentivize technology transfers, investment in skills, development, regulatory capacity building – and all the things that we repeat ad nauseum – there needs to be an assurance that there’s going to be a market when all of this is built,” he stressed. Tippoo added that African governments and other stakeholders had to understand that a “resilience premium” would need to be paid to ensure that pharmaceutical manufacturing capability is built in Africa. “There is no way in which vaccines coming out of Africa in the next five or 10 years can compete on a cost of goods perspective, with Indian manufacturer factories, or even multinationals because they’ve monetised the investment over time, and they have economies of scale,” he added. Diversification a ‘win-win’ for Africa, Europe and globally However, other participants pointed out that over the long-term, diversification of sources for pharma procurement is going to be a win win, given the comparatively limited number of suppliers, for some key global health products. Interruptions to key medical supply chains were particularly evident during the early stages of the COVID pandemic, exposing their fragility, even for more affluent countries. Sibilia Quilici, Executive Director, Vaccines Europe, pointed out that from the European perspective, too, it would be beneficial to reduce dependence on what is now a comparatively small number of suppliers, mainly from India and China, and integrate Africa’s supply chains with global ones: “In the context of this discussion on improving manufacturing capacities in Africa, also for APIs [active pharmaceutical ingredients] it is good to be aware that the EU, the largest API importer in the world is looking for supply chain diversification for products where dependence on a small number of suppliers from India and China is a concern. “This could be a win-win for Africa, EU, local and global industry”. Image Credits: Rodger Bosch for MPP/WHO, WHO . Posts navigation Older postsNewer posts