Reversing Years of Opposition, Taliban Initiate Polio Vaccination Campaign; Tedros Meets Afghan Health Minister in Geneva 09/02/2022 Shadi Khan Saif A child in Pakhistan getitng his polio drops. As Afghanistan’s fragile health system battles for survival, hard-earned gains of the past 20 years in the tenacious battle against polio are under threat. But on a hopeful note, the new Taliban regime has just launched its first national polio vaccine campaign – reversing years of opposition to the life-saving intervention. Afghanistan witnessed the lowest ever polio transmission in 2021 providing what WHO officials have described at a recent Executive Board meeting as an “unprecedented” opportunity to interrupt transmission of wild poliovirus and ultimately achieve eradication. Only four cases of wild poliovirus type 1 (WPV1) were reported in the country last year. Previously, dozens of such cases would typically emerge. Leading up to this, two nationwide campaigns undertaken last year before the Taliban takeover in August 2021. The campaign reached eight million children, including 2.6 million who were vaccinated for the first time. This has raised hopes for an end game for the crippling virus. Taliban launch first-ever polio campaign – as Afghan health minister visits Geneva Dr Qalandar Ebad, Acting Afghan Minister of Health After years of opposition to vaccination, the Taliban government have pledged to maintain the momentum. The new Afghan government recently launched its first national polio immunization campaign for 2022, targeting 9.9 million children aged 0 – 59 months. However, the campaign is taking place against the continued spectre of hunger, humanitarian crisis and a “dire” health situation, according to WHO’s Director General Dr Tedros Adhanom Ghebreyesus. Tedros met this week in Geneva with the Taliban’s acting Health Minister, Dr Qalandar Ebad, who arrived Sunday with a larger Taliban delegation, upon the invitation of the humanitarian group, Geneva Call, as part of an effort to unblock desperately needed humanitarian aid. “Despite some improvements since then, the health situation in Afghanistan is still dire, and the acute humanitarian crisis is continuing to put lives at risk,” wrote Tedros in a tweet Wednesday, after Tuesday’s meeting. Calling for continued dialogue with the Taliban, Tedros’ message also focused on the need to support Afghanistan’s COVID response and girl’s education. It was his second meeting to date with the new Afghan health leader, following a visit by the WHO DG to Kabul in September 2021. Yesterday, I met with Qalandar Ebad, the Taliban Health Leader, to discuss the health needs in #Afghanistan. My full statement below: pic.twitter.com/v8GXhv6aLh — Tedros Adhanom Ghebreyesus (@DrTedros) February 9, 2022 Taliban campaign reverses years of vaccine hesistancy Desperately seeking international recognition and support, the Taliban-run Ministry of Public Health clearly now sees the uptake of polio vaccinations as an international and domestic win-win. It has taken the lead in promoting polio vaccinations and convincing people to get their children vaccinated, reversing years of vaccine hesitancy that characterised hardliners in the group. In a televised interview this week, Ebad, a medical doctor by training, mentioned that immunization was among his ministry’s top priorities. “Together with the international community, we would try our best to eradicate polio that is nearly diminished from Afghanistan. As a physician, I assure people that this is a disease that needs to be defeated on science-based international strategy, be it polio, measles or Covid-19 we would follow a global strategy,” he said. Afghanist & Pakistan are only countries remaining with wild poliovirus Afghanistan and Pakistan are the only countries in the world that have been unable to stop endemic transmission of wild poliovirus, according to the World Health Organization (WHO). Pakistan has long blamed its polio cases on Afghan migrants and refugees, so Afghanistan’s battle is also one with high stakes for neighbouring countries who are concerned that any renewed outbreaks could spill over borders. While Afghanistan and Pakistan are still grappling with the wild poliovirus, the world is gearing up to roll out a new generation of polio vaccines to fight vaccine-derived polio cases that have been a problem in 27 countries in the African, Eastern Mediterranean, Europe and Western Pacific regions. Finishing the eradication of wild polio in Afghanistan and Pakistan as well as advancing new vaccines to stamp out vaccine-derived polio cases in Africa, the Middle East and parts of Latin America and Asia, were twin themes at the recent WHO Executive Board discussions on polio eradication – a health stream that is one of the largest in WHO’s budget. The discussions, which continued for hours, featured countries in Africa, Asia and the Eastern Mediterranean describing the challenges they face in rolling out a new generation oral polio vaccines to help wipe out vaccine-derived polio cases from older, less effective vaccine technologies – while remaining watchful of any risks from wild polio outbreaks. Ground Zero in the polio battle Last year, Africa was declared free of polio as a result of a determined 30-year effort. But in the fight against wild polio, Afghanistan remains ground zero in the battle. And the new immunization drive is taking place against the spectre of health worker protests that are stalling health service more generally. Evidently exhausted from relentless hours of duties, doctors and other frontline health workers have been on the street in a number of provinces protesting against the non-payment of salaries for months as the Taliban government struggles to manage budget flows amid the tough international sanctions imposed on it by the west. One protesting doctor based in the northern region of the country, Habibaullah Ahmadi, told the Health Policy Watch that he had not received his salary for 10 months now and was battling to survive. “We have decided to only continue work with few more days, but if we are still not paid our salaries, we will close the door of the hospitals because we all have families and we have a lot of problems, and we ask the international community to intervene and pay our due rights,” said Ahmadi. Local authorities acknowledged the issue of non-payment of salaries, but blame the freeze on Afghan state reserves worth around $9 billion in the US for it. Recently, doctors returned to work when the regional health head, Zaman Azami, assured the protesting health workers that their problems would be resolved ‘soon’. The northern region of Afghanistan was the site of some of the deadliest clashes between the Taliban and the former government forces backed by NATO, which resulted in disruption to the immunization drives last year and the emergence of most y of the new wild polio cases. Although fighting has mainly ceased with the rise to power of the Taliban, the economic hardship that has followed has had an impact on the vaccination drives. Meanwhile, the hardline Islamic State’s Khorasan (IS-K) chapter that recently claimed multiple deadly attacks in Afghanistan, continues to oppose the vaccination. In the eastern provinces of Afghanistan marred by IS-K terrorism, at least four members of the polio vaccination team were gunned down and three others wounded last June. Back in March, three more members of polio vaccination team, all female, were shot dead by unknown assailants in the same area. Vaccine scepticism and attacks on vaccination teams Children in Pakistan show proof of vaccination against polio. Researcher and author, Ziaur Rehman, who has worked on polio campaigns for years, told Health Policy Watch that although the Taliban’s public stance on vaccinations has evidently changed, the mindset they nurtured against vaccinations during the past 20 years of insurgency will take years to address. “If you remember it was broadly reported that the American CIA had used a Pakistani doctor, Shakil Afridi, to set up a fake polio vaccination campaign as a cover for the search for Al Qaeda chief Osama bin Laden in Pakistan. Ever since then, health authorities in Afghanistan and Pakistan have been struggling to win public confidence on the immunization,” Rehman said. A bunch of the Taliban splinter groups, particularly in the border regions between Afghanistan and Pakistan, continue to issue death threats to all those involved in the immunization campaigns despite the rise to power of the group in Kabul. Echoing these concerns, senior Afghan paediatrician and former deputy director health, Dr Kabeer Ahmad told Health Policy Watch that scepticism towards polio and other vaccines still remain high, particularly in the rural communities. “If you go to the remote villages there are many people who still have serious doubts about the vaccine. It is in these communities, which also frequently travel between Afghanistan and Pakistan, that you see the virus transmitting.” It is worth noticing that the WHO had said in a statement that Afridi was never part of any polio vaccination program in Pakistan – genuine or fake – and that baseless reports linking him to anti-polio efforts had damaged the ongoing vaccination campaign. Remarkable progress At the WHO Executive Board last month, WHO officials praised the “remarkable progress” in the fight against the virus in Afghanistan, and it was labelled as the “best opportunity” to end polio for the entire world. “To reach the final goal (of polio eradication). We need more of what we saw in 2021, the government leadership at all levels, and embedded access to children, informed and engaged communities and the highest quality of operations. And we need all of this to be sustained until transmission (of the virus) is interrupted, and the number of paralyzed children is at zero and kept,” said Dr Ahmed Salim Saif Al Mandhari, WHO Regional Director for the Eastern Mediterranean Region, which includes Afghanistan and Pakistan. The WHO has an estimated budget of $4.2 billion set aside for the five-year Global Polio Eradication Initiative 2019-2023 in partnership with UNICEF. The second component, starting in 2022, is the one-time cost of $121 million to have oral polio vaccine stockpiles (OPV) in place for use post-certification. Together, it brings the overall cost to achieve and sustain polio eradication to $5.1 billion It was also underlined at the meeting that the world must not overlook the challenges that remain on this front such as the outbreaks of vaccine-derived polio viruses. Taliban seek international financial support “I urge the member states to make domestic funding available to respond when needed, so that National Public Health capacities respond to outbreaks, as well as the COVID 19 pandemic, and are robust and can be integrated into broader public health services across steadily,” said Dr Al Mandhari, who also visited Kabul and met the Taliban leadership along with Tedros in September. At the EB, many members state expressed commitment and support for the WHO’s immunization drive. It was stated that the financial support from the Global Polio Eradication Initiative will continue until the end of 2023 for the 10 countries at higher risk for polio, including Afghanistan while the 37 low-risk polio countries are being funded through the WHO based budget. After the assurance of funds by the international community, Ebad said that the immunization programs would cover the entire country rather than the 30-40% previous target. The novel oral polio vaccine for type two, which received WHO’s first-ever emergency use listing in November 2020, has been introduced and delivered at scale in 12 countries using almost 200 million doses aimed at eradicating vaccine-derived polio transmission. The supply chain has since been strengthened with 640 million doses planned for delivery during 2022, according to the WHO. Still, at the Executive Board meeting of the WHO last month, the global health body’s chief, Tedros Adhanom Ghebreyesus warned against lowering guard against the crippling virus. “When there is success, we tend to lower our guard. So what I say is we need to be more aggressive, and we shouldn’t lower our guard. That’s what I say but eradicating polio is within reach,” said Tedros. Image Credits: UNICEF Pakistan, Ministry of Public Health, Afghanistan. Two Years into COVID Pandemic, 92 % of Countries Still Face Significant Health Service Disruptions 08/02/2022 Maayan Hoffman Healthcare workers in Nigeria have struggled to maintain routine childhood vaccination services during the COVID-19 pandemic. Two years after the COVID-19 pandemic began, over ninety percent of countries continue to face ongoing disruptions to their health systems, according to a survey published Monday evening by the World Health Organization. The WHO Global Pulse Survey, the third of its kind since the start of the COVID-19 crisis, analysed responses from 129 countries, territories and areas on the continuity of essential health services in the latter part of 2021. The aim, WHO said, is to gain insights into the impact of the pandemic on these services and related changes that countries could be facing. At the end of the year, disruptions were occuring across practically every sector of health services – and at roughly the same rates as the first quarter of 2021, when vaccines were not yet widely available, found the survey, which covered both high, middle and lower income countries. “Findings from this latest survey, conducted at the end of 2021, suggest that health systems in all regions and in countries of all income levels continue to be severely impacted, with little to no improvement since early 2021, when the previous survey was conducted,” stated a WHO press statement. Strikingly, health workforce issues were found to be the biggest barrier to scaling up access to COVID-19 testing, treatment and vaccination. WHO said this is likely a result of staff exhaustion, workforce infections, and health workers leaving their jobs due to the stress of the pandemic. More than a third (35%) of countries reported health workforce challenges more broadly beyond the bottlenecks in COVID-related healthcare services. Disruptions across all major areas of healthcare services In terms of other challenges, countries reported disruptions across all major health areas: sexual, reproductive, maternal, newborn, child and adolescent health, immunization, nutrition, cancer care, mental, neurological and substance use disorders, HIV, hepatitis, TB, malaria, neglected tropical diseases and care for older people. Moreover, at the same time that countries were scaling up their administration of COVID-19 vaccines, they reported increased disruptions in routine immunization services. More than half of the countries responding to the survey said that many people are still unable to access care at the primary care and community care levels. Elective surgeries were also disrupted in 59% of countries, which WHO said could have accumulating and long-term impact on personal health and well-being. Nearly one-third (32%) reported challenges accessing emergency room services. Some 66 core health services across multiple delivery platforms and health areas were included in the survey. Plans for recovery At the same time, countries have tried to further beef up their responses to adapt and rebound from the continuing crisis, including with the provision of more home care and telemedicine; stepped up healthworker recruitment and training; procurement of “surge commodities” and more public financial support for the delivery of certain services, such as COVID testing or vaccination, to ensure wider uptake. One-half of countries surveyed have developed a health service recovery plan to prepare for future health emergencies, and 70% of countries having allocated additional government funding to health workforce strengthening; access to medicines and other health products; digital health; facility infrastructure; and public engagement and communications. As the survey responses were gathered up to November 2021, the data does not reflect the complex impacts on health services of the Omicron wave – which hit in late November. That wave has infected unprecedented numbers of people in most countries around the world, including large numbers of healthcare workers. At the same time, hospitalization rates have been proportionately lower than past COVID waves. That allowed some countries to refocus efforts on other emergency and routine hospital procedures – although hospital capacity in other countries has been strained by surges in moderately and seriously ill COVID patients. The full report can be found here. Image Credits: Twitter: @WHOAFRO. Africa CDC is Elevated to Status of Continental Public Health Agency 07/02/2022 Paul Adepoju The African Union held its annual summit in Addis Ababa The African Union has decided to elevate its African Centres for Disease Control and Prevention (Africa CDC) to the status of an autonomous public health agency for the continent – rather than operating simply as technical arm of the AU. “Africa CDC will now be an autonomous health agency for the continent. Until now, Africa CDC was a specialized technical institution. It will now be elevated into a full public health agency for the continent, which will be more or less autonomous,” declared Dr John Nkengasong, Africa CDC’s director, on Sunday, the second day of the 35th AU summit that took place over the weekend in the Ethiopian capital of Addis Ababa. The elevation of the Africa CDC – which will now report directly to Heads of State of AU Member Countries – signals the growing member state commitment to strengthening the continent’s response to current and future disease outbreaks, he added. This development, Nkengasong said, is as a result of continent leaders’ renewed perception of disease as a security threat for the continent, in the wake of the COVID pandemic, among other disease trends. “They want to have full, timely access to anything that happens within the continent so that they can provide policy guidance. So I think that is extremely encouraging,” he added. Summit leaders also pledged their support for the full-fledged establishment of the African Medicines Agency (AMA); aggressively combating malaria and female genital mutilation; and a 2022 AU “Year of Nutrition” – which would aim to get the continent back on track towards achieving Sustainable Development Goals for nutrition – as well as for resilient agriculture. Africa CDC Director John Nkengasong Kenya calls on fellow heads of state to ‘sign up’ for AMA Treaty; Senegal is latest country to ratify The African Medicines Agency (AMA) treaty, which is now being backed by 30 African countries as previously reported by Health Policy Watch, was another major topic of discussion, with various calls by leaders and stakeholders for the agency to fully commence its operations soon. Senegal became the latest country to officially ratify the AMA treaty, while Kenya’s president hinted that the East African powerhouse Kenya could join soon. Addressing his fellow heads-of-state, President Uhuru Kenyatta issued a strong call to African leaders to “sign up as soon as possible for this initiative” – saying that once operational, it will be critical in keeping people on the continent safer from disease threats. “Several African countries have now signed the AMA treaty, enabling better access to newer, safer medicines. I urge my fellow heads of state to sign up as soon as possible for this initiative,” Kenyatta declared. At last month’s World Health Organization (WHO) executive board meeting, Kenya also expressed commitment to the AMA, in remarks made on behalf of the African bloc of WHO member states. Kenya’s President Uhuru Kenyatta speaking at the African Union’s 35th Summit Senegal’s move means that so far 22 countries have ratified the treaty, while eight more have signed it, for a total of 30 countries in formal support. Another 25 countries, including the economic and population powerhouses of Kenya, South Africa, Ethiopia and Nigeria have yet to sign or ratify the treaty instrument. See the countdown here: AMA countdown gauge Infogram Review of proposals for a host country for the new AMA institution are set to begin in April, with the first AMA Conference of State Parties (CoSP) set for May – where an assessment report will be presented for discussion on recommendations for a venue and next steps to establish the AMA. Malaria goals lag African Union media briefing on the Malaria Progress Report 2021, by Kenya’s President Uhuru Kenyatta and AU Health, Humanitarian & Social Affairs Commissioner Samate Cessouma Minata On malaria, the Malaria Progress Report 2021 underlined that the African continent is not on track to eliminate malaria by 2030. Africa continues to account for the lion’s share – 98% – of global malaria deaths. Out of the total of 611,802 malaria deaths that occurred on the continent in 2020, the report noted that about 49,000 of the deaths were attributed to disruptions to malaria programmes and broader health services caused by the COVID-19 pandemic. Addressing journalists at the summit, Kenya’s President Kenyatta, who also chairs the African Leaders Malaria Alliance said far-reaching strategies need to be adopted to eliminate malaria. “For us as a continent, we have attempted to fight malaria in the past but the disease is still a major threat to health and development in Africa,” Kenyatta said. However, he added that African countries are making progress in implementing a four-point legacy agenda of digitization and scorecard accountability and action plans; a multi-sectoral advocacy, action and resource mobilization; regional coordination and access to life-saving commodities. “Happy to report that we have made good progress in implementing the four-point agenda. Countries continue to expand the use of digital tools to strengthen evidence-based accountability and the fight against malaria. All countries are implementing national scorecard tools on malaria, reproductive, maternal, newborn and adolescent and child health care, neglected tropical disease, nutrition and community scorecards,” he added. See related Health Policy Watch story Digital Scorecards Provide Citizens with Information on Neglected Tropical Diseases Year of nutrition At the summit, AU’s plan to declare 2022 as the “Year of Nutrition” was also finalized. The plan notes that Covid-19 has greatly exposed the economic vulnerability of African countries, as well as the weaknesses of health and food systems. “With the COVID-19 pandemic, much of human capital gains in many economies over the past decade is at risk of being eroded. The price to pay for keeping the virus at bay has been, in many African countries, at the expense of gains made in reducing malnutrition,” the AU stated. Specifically, it noted that the prevalence of wasting will also increase due to higher risks of acute food insecurity. The plan calls for urgent action to recoup and build upon pre-pandemic gains made against undernutrition and malnutrition, including reducing childhood wasting (low weight relative to height) and stunting (low height relative to age). Stunting, a powerful indicator of undernutrition, still affects some 150.8 milllion children under the age of five, including 58.7 million African children. Currently only seven AU member states out of 55 have stunting rates below 19%, while only 15 member states have child wasting prevalence below 5%. SDG Goal 2 – Zero Hunger – calls for reducing the prevalence of stunting by 40% by 2025, in comparison to 2012 levels. “Investing in human capital is now more important than ever through designing the needed interventions especially targeting the most vulnerable,” the plan asserts. Africa remains the only continent with high levels of malnutrition & suffers slow progress to reverse the situation. Data from Continental Nutrition Accountability Scorecard indicates an increase in the number of stunted children from 50.6 million in 2000 to 58.7 million in 2017 pic.twitter.com/4n9chT6Vxx — African Union (@_AfricanUnion) February 7, 2022 Closing the Cancer Care Gap in Indigenous, Child, and Ageing Populations for World Cancer Day 04/02/2022 Raisa Santos Cancer statistics for the Maori people are very stark – 20% are more likely to develop cancer than non-Maori. For the indigenous people of New Zealand, the Māori, cancer statistics are bleak, as they are 20% more likely to develop cancer, and twice as likely as non-Māori to die from it. But New Zealand-based Cancer Control Agency, Te Aho o Te Kahu, is trying to beat back against this inequity and close the gap in care for Māori people. This story, and more, were among the many featured as part of World Cancer Day, a global initiative led by the Union for International Cancer Control (UICC) on 4 February. The theme for this year – ‘Close the Care Gap’ – addresses a need to address inequities in cancer care globally. This inequity has been even more pronounced in recent years, with the COVID-19 pandemic setting back treatment services and progress in many parts of the world. “We see [inequities] on a day to day basis, and they impact the chances of someone developing cancer in their lifetime, and also someone surviving cancer,” said UICC CEO Cary Adams. Featured speakers and experts from around the world – from New Zealand, Switzerland, Kuwait, the Philippines, and others, discussed ways to close the cancer care gap, including in ageing and indigenous populations, and told stories of cancer survivors. Engagement with indigenous groups necessary to address cancer care inequities in New Zealand Michelle Mako, Equity Director at Cancer Control Agency, New Zealand, Engagement is key to addressing the inequities surrounding cancer care, said Michelle Mako, Equity Director of the Cancer Control Agency. While exposure to risk factors such as smoking, alcohol, poor nutrition, lack of physical activity, and more drives up cancer incidence in Māori people, lack of access and lower utilization of primary care has also impacted cancer prevention and treatment. “Like many other nations, we are also seeing late detection of cancers in emergency departments, and we’re also seeing higher cancer rates with lower survival,” said Mako. To understand the gaps in care and potential solutions, Mako and the Cancer Control Agency spoke to around 2800 Māori with lived experiences of cancer in their families, as well as providers in the community. New Zealand is also going through a series of health reforms, one of which will incorporate a new agency for the Maori people – the Māori Health Authority, which will work with the NZ Ministry of Health and other local health agencies to ensure equitable access to care for the Maori. Looking forward, Mako hopes that equity is achieved with cancer care in New Zealand, especially with these initiatives and more. “I’d like to think that equity stops being a vague promise to do better or a fancy job title. I really hope that delivery equity just becomes standard practice and part of normal cancer care in the future.” Translating cancer care to aging populations Colon cancer rehabilitation trials in the UK. Quality of care is important in cancer care for ageing populations. With the number of people 60 years and older to double in the next twenty years, and with cancer cases already impacting 37% of the elderly – a number that will also undoubtedly rise in the next twenty years, it is crucial that cancer care also address the needs of ageing populations. “The cancer workforce is not always prepared to meet the complex needs of patients with cancer,” said Nicolo Battisti, President-Elect of the International Society of Geriatric Oncology. Currently, in some parts of the world, there are few geriatric oncology clinics that are able to provide comprehensive care to these patients. Older people with cancer also tend to be excluded more frequently from innovative clinical trials. But Rania Azmi, President of the Kuwait-based Fadia Survive and Thrive Cancer Association, has created an initiative centered around nine pillars that focus on meaningful discussion about elderly patients with cancer and patient-centered care in order to bring light to this issue. Rania Azmi, left and Nicolo Battisti, right One of the pillars considers the issue of functional age as opposed to chronological age for cancer patients, which makes all the difference for treatment. “It’s not just the number – 60 or 70 or 80 that defines who’s at risk for cancer. It’s organ function,” said Azmi. Elderly patients also experience different cognitive changes and pain when it comes to cancer, so all knowledge and cancer control, including prevention, early detection, diagnosis, treatment, and even palliative care and quality of life, must be translated into actions to address their needs. “It’s really beyond oncology. To achieve [quality of care in elderly cancer patients] we need to hear the patient’s voice and have inclusion of patient decision in treatment,” Azmi noted. Providing financial and psychosocial support to child cancer patients in the Philippines The Kythe Foundation of the Philippines works with families and children with chronic illnesses. Children and younger populations also have difficulties in accessing quality care, especially in the Philippines, according to Philippines-based Kythe Foundation co-founder and Executive Director Maria Fatima Garcia-Lorenzo. The Kythe Foundation provides both psychosocial support and family support to children and families with chronic illness. ‘Adopted’ patients are also given full financial support – medicines, transportation, money for clean water – so that they can have a greater chance of surviving cancer. To celebrate their 30th anniversary, the foundation hosted a webinar in conversation with older cancer survivors and younger survivors, where they found striking differences in accessing treatment. “Our younger survivors had to really strive and line up to get financial help [for care]. They were not even diagnosed right away and had to go from one hospital to another to get proper diagnosis,” said Garcia-Lorenzo. Maria Fatima Garcia-Lorenzo, Kythe Foundation One survivor, according to Garcia-Lorenzo, did not even initially know what cancer was, causing him great fear and preventing him from complying with treatment. “You could see the disparities, the inequities of the health system – the haves and the have-nots. Everyone should have access to treatment, medicine, and information.” The Kythe Foundation is already pushing for more funding from the Philippine government, health departments, and insurance agencies to provide for the needs of cancer patients. Image Credits: einalem, World Cancer Day , Queen's University/Flickr, PTVph/Twitter . Africa Has Enough COVID Test Kits – Nkengasong 04/02/2022 Paul Adepoju Africa CDC director John Nkengasong Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC) has told Health Policy Watch that the continent is not in short supply of COVID-19 test kits. According to him, every African country that is in need of the test supplies can get it if they want. An open letter dated 31 January that was written by concerned members of civil society, clinicians, advocates, and communities affected by COVID-19, to the World Health Organization (WHO) urged it to rapidly recommend self-testing for COVID-19. While calling on the global health body to expedite the finalisation and release of a self-testing guideline for SARS-CoV-2 infection that includes a strong recommendation in favour of widespread access to self-testing, they noted that low- and middle-income countries (LMICs) represent nearly 85% of the global population but that only 40% of tests for COVID-19 have been used in LMICs. “As a result, the reported average daily testing rate of high-income countries is, per capita, nearly 10 times higher than that of middle-income countries and close to 100 times higher than that of low-income countries,” the letter stated. In Africa, according to the experts, citing WHO AFRO region, said 85% of COVID-19 infections are going undetected. “This inequity in access to the diagnostic tools that trigger life-saving individual and public health measures is part of the same ‘medical apartheid’ that has plagued the rollout of COVID-19 vaccines,” the experts noted. But on Thursday, Nkengasong noted that Africa has seen a remarkable change and improvement in access to testing. “We are here in the middle of the African Union (AU) Summit and we are characterizing it as a COVID-free summit, which means every day we conduct testing on all the delegates, and those are thousands of people that are tested. We have not run out of tests,” Nkengasong said. He said if countries follow the guidelines that the Africa CDC has given them, they will be able to access testing. Prioritising testing at the country level He argued that the major determining factor for closing the COVID-19 testing gap in Africa is at the country level — enjoining governments to prioritise testing as a major cornerstone of their pandemic response. While the continent’s testing data fluctuates from one week to another, it does not suggest that the continent is in short supply of testing kits, he added, describing the trend as a reflection of the priorities of the governments concerned. “Testing will continue to be key. We see the test numbers fluctuate. Some weeks you have a very high increase in testing and then the following week you see a decrease. But that doesn’t necessarily reflect a lack of tests. Instead, he said the trend could suggest that countries actually engaged in testing or they are doing selective tests — “which most of the cases is about people who have symptoms or people that are trying to travel, not really systematic testing going on”. In May 2020, the WHO published criteria in which it described a positive rate of less than 5% as an indicator that the epidemic is under control in a country. While this data for several African countries is not available, available data showed positive rates on the African continent ranging from 0.64% in Rwanda to 37.4% in Tunisia. More Clarity on Negotiators to Take Forward WHO Pandemic ‘Instrument’ Talks 04/02/2022 Kerry Cullinan WHA’s Special Session resolved on 1 December 2021 to negotiate a new global pandemic instrument. Representatives from Brazil, Egypt, Japan, Netherlands, South Africa, and Thailand are to make up the World Health Organization (WHO) Intergovernmental Negotiating Body (INB) on a future pandemic instrument, according to Knowledge Ecology International. The countries each represent a different region of the WHO, namely Africa (South Africa), the Americas, known as the Pan-American Health Organisation (Brazil), the South-East Asian Region (Thailand), Europe (Netherlands), the Eastern Mediterranean (Egypt) and the Western Pacific (Japan). South Africa confirmed that it had been chosen to represent Africa at the INB at last week’s WHO executive board meeting, while the European Union announced that it would be represented by an official from the Netherlands. Last year’s World Health Assembly (WHA) Special Session resolved to start intergovernmental negotiations “to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”. According to the WHA resolution, the first INB meeting shall be held no later than 1 March to “elect two co-chairs, reflecting a balance of developed and developing countries, and four vice-chairs, one from each of the six WHO regions” as well as “define and agree on its working methods and timelines”. The resolution also directs the INB to “first identify the substantive elements of the instrument and to then begin the development of a working draft to be presented, on the basis of progress achieved, for the consideration of the INB at its second meeting, to be held no later than 1 August 2022”. The INB has until the 77th WHA next year to present a draft of the instrument, but needs to present a progress report to this year’s WHA. Thirty African Countries Now Back Africa Medicines Agency Treaty But Continent’s Economic Powers Still Hold Out 03/02/2022 Paul Adepoju Ambassador Samate Cessouma Minata, AU Commissioner for Health, Humanitarian Affairs and Social Development (HHS) Some 21 countries have now ratified the African Medicines Agency treaty – well beyond the 15 ratifications reached in November 2021, which allowed the AMA treaty instrument to formally take effect. Egypt, Africa’s third most populous country, is the most recent state to have both ratified and deposited the treaty – marking a significant milestone in the efforts to get the continent’s bigger players on board. Altogether, 19 African countries have both ratified and deposited the AMA treaty instrument to the AU secretariat, said Cessouma Minata Samate, African Union Commissioner for Health, Humanitarian Affairs and Social Development, at a press briefing on Thursday. She was speaking at a briefing on the margins of the 35th African Union Summit, which takes place this weekend. Two more countries, Morocco and Saharawi, have also ratified the treaty – but are yet to deposit it – rounding out the 21. Another nine countries have signed the treaty, but are yet to ratify it – including Equatorial Guinea and Comoros, which signed over just the past week, said Samate. All in all, that makes for a total of 30 countries that are formally on board with the treaty through signature, ratification, or both – while 25 still remain uncommitted. The new agency is supposed to provide a streamlined regulatory authority that would improve quality medicines access, and combat substandard imports, backers say. “The AMA will also guide the regulation of medicines, and facilitate access to quality medicines on the continent,” underlined Samate. Africa’s biggest economies still hold out Despite that promise, the 25 countries that have not yet signed the treaty include most of Africa’s population and economic powerhouses — such as Nigeria, South Africa, Kenya and Ethiopia. Responding to queries regarding the fence-sitters, Samate deferred, attributing the delays to variations in respective countries’ signing and ratification procedures. “I do not want to answer why Ethiopia did not sign; I am not part of the government. But each country has its procedure. There are several procedures involved. There is a whole process for it to arrive at the Parliament which will ratify it, and it depends on each country,” she said. “Each country has its rules for signing and ratifying treaties,” she said. She however added that since the treaty is new, sufficient time has to be given to Member States to sign and ratify it. Ultimately, however, all member states recognise it is in the best interest of citizens on the continent. “I am sure that all the countries are committed.” AMA will improve medicines regulation and access on the continent State of play as of 2 February in the alignment of 30 AU member states around the AMA treaty. Another 25 states have yet to sign or ratify. Samate noted that the AMA will be important in coordinating between the continent’s sub regional blocs, which have different economic alliances, also affecting trade and thereby medicines regulations. “The agency will coordinate the actors at the level of our subregional economic communities, and will work with AU Member States to enable us to have efficient health systems to treat our various populations.” “It’s important for us to have an agency for ourselves – to serve as a regulator for medicines issues on the continent,” she said. Others have emphasized that the AMA could help speed access to medicines – by conducting reviews and issuing recommendations on new treatments, which could take counties much longer to tackle individually. And it could help bring down some medicines prices by facilitating regulatory harmonization – which permits more bulk imports. In addition, it is hoped that the agency can play a role in fighting substandard and fake medicines. Currently WHO’s African Region suffers from the highest rates of reports of fake and substandard medicines in the world, according to both the WHO and AU officials. Timeline for setting up the new agency The next step in transforming the AMA from a treaty to an actual institution is to decide on a host country for the agency’s headquarters, Samate told journalists. This is not expected to be completed at the AU Summit – insofar as the criteria and process are yet to be announced. But she affirmed that the process would get underway “very shortly.” “There will be a process to allow the member states to decide, very shortly, which African country will host the AMA,” she told journalists. Sources, however, told Health Policy Watch that the process of assessing countries vying to host the AMA may not really begin until April. However an initial meeting of the AMA Conference of State Parties (CoSP) is scheduled for May – where an assessment report will be presented for discussion on recommendations for AMA host country. Following that, the terms of reference for the AMA Director-General will then be considered by the CoSP – to pave the way for recruitment of an agency head. Lastly, the site for the proposed AMA headquarters is expected to be adopted by the AU Assembly to be held in July 2022. Meeting ambitious goals The AMA treaty document was first approved by the African Union in 2019. At a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda in December 2021, panellists described the AMA as critical to Africa achieving the set goal of producing 60% of vaccines on its own soil by 2040. Ahead of the African Union Summit held over the past weekend, the African Medicines Agency Treaty Alliance (AMATA), an alliance that represents patients, academia, civil society, and industry set up to advocate for the ratification and implementation of the AMA, applauded the momentum reached so far. As the 35th #AUSummit takes place, we as #AMATA members call on the @_AfricanUnion to now prepare for the practical implementation of the Treaty establishing the #AfricanMedicinesAgency, bringing Africa🌍a step closer to having a continent-wide regulatory agency! pic.twitter.com/x8K1aORGZN — IAPO (@IAPOvoice) February 4, 2022 They called for a set of key steps to be taken in order to operationalise the Agency, including setting up a secretariat and choosing its location, adequate human resource capacity to operationalise its mandate and a sustainable funding model to ensure short- and long-term stability. AMATA also stressed the importance of recognizing patients as key partners in the development of the Agency – as part of a framework of engagement with non-state actors, including academia, research bodies, private sector and other civil society groups. They also appealed to all other African countries to ratify the AMA to “strengthen the continent’s capacity and preparedness to deal with future pandemics”, foster a spirit of cooperation to enable the development of medicines and vaccines, and safeguard the health of the continent and to protect citizens of Africa from fake m. Image Credits: African Union . Cancer Services and Routine Immunizations Backlogged – as Some Countries Anticipate Pandemic ‘Ceasefire’ – WHO 03/02/2022 Elaine Ruth Fletcher & Raisa Santos Hans Kluge, WHO European Regional Director Cancer services remain backlogged in many parts of the world due to the effects of the two-year-long COVID pandemic – even as Europe hopes a pandemic “ceasefire that could bring us enduring peace” , said WHO’s European Regional Director Hans Kluge Thursday on the eve of World Cancer Day. Meanwhile, in Latin America, routine childhood immunizations are down by around 10% as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases, said Carissa Etienne, Regional Director of the Pan American Health Organization in a briefing Wednesday evening. Both WHO regions, which include some of the world’s highest income countries, as well as middle income nations, alongside low-income states, continue to face striking regional imbalances in vaccine distribution, top officials in the two regions also stress – with some countries reaching 70% COVID vaccine countries or more – while others only have reached about 30% of eligible adults with jabs, both Etienne and Kluge stressed in separate press briefings. And that still leaves some countries disproportionately vulnerable to the ongoing effects of the Omicron variant – as well as to risks of new emerging variants. Cancer – knock-on effects will last for years Cancer services were disrupted up to 50% in the WHO Europe region. The two-year ongoing pandemic has had “catastrophic” effects on people with cancer, said Kluge, in his remarks – “going far beyond the disease itself.” One in four people in WHO’s European Region will receive a cancer diagnosis at some point in their lives – and cancer accounts for more than 20% of morbidity and mortality in the WHO region that extends from the Central Asian republics to the United Kingdom, he noted. In the European region, cancer diagnosis and treatment services saw disruptions of up to 50% in the early stages of the pandemic he noted. And while many EU countries have since rebounded, the picture remains uneven regionally and around the world. The latest WHO Global Pulse survey on disruptions in essential health service found that in the last quarter of 2021, countries worldwide were still experiencing disruptions in cancer screening and treatment services of between 5-50%, Kluge said. “The knock-on effects of this disruption will be felt for years,” Kluge added, noting that 44% of countries worldwide were reporting backlogs in cancer screening in the second half of 2021. Any post-Omicron ‘respite’ must be used to restore other essential health services Problems are compounded, he added, by the fact that the “health workforce is overstretched and exhausted – after being repurposed to address the direct impact of the virus. “Any respite the widespread immunity provides, thanks to vaccination and in the wake of the less severe Omicron, together with the coming spring and summer season, must be used immediately to enable health workers to return to other important health care functions, in order to bring backlogs for chronic care services down. “As we go forward, maintenance of essential health services, including services along the journey of cancer care, from prevention, early detection, diagnosis, treatment and quality of care will be a component of emergency planning and response,” he said. Americas also struggling to overcome disruptions in routine childhood vaccinations A child receives a routine vaccination in Cuba, which is a world leader in childhood immunization. Meanwhile, speaking from Washington DC, PAHO’s Etienne sounded a similar theme. But her message was focused around pandemic-related setbacks in childhood vaccinations across the WHO’s Americas’ region – which includes the affluent USA and Canada, alongside high, middle and low income countries of Latin America and the Caribbean. Routine childhood vaccinations for a third dose of diphtheria, tetanus, pertussis (DTP) vaccine has declined by 10% in the region, as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases because of lower immunization coverage, she said: “Despite the tremendous achievements of immunization programs in past decades, that progress has stalled in some countries, and has even reversed in this region.” Carissa Etienne, Director of the Pan American Health Organization/WHO Region of the Americas While the goal was to fully cover at least 95% of eligible children in 2020 with the DTP vaccine, 26 countries and territories of the Americas did not reach that goal. And some 14 countries in the region had particularly low coverage with the third dose – of 10% or less. As in Europe, she attributed the setbacks to the reassignment of healthcare professionals from primary care centers to hospitals and intensive care units – alongside public hesitations about getting vaccinated during the pandemic. PAHO is currently working with Ministries of Health across the Americas to revitalize family immunization programs as one of their “highest priorities”. “We are at a juncture where it is urgent to look at routine immunization programs,” said Etienne. As countries reopen – uneven vaccination coverage exacerbates future variant risks Both Europe and the Americas also are facing major inconsistencies in vaccine coverage rates within countries of the region, the officials also noted. And that poses additional risks as countries relax restrictions, Kluge stressed. “We in the European region have a unique situation,” Kluge said. “Once the Omicron wave has subsided, there will be a large capital of [SARS-CoV2] immunity, due to the infection in general, and quite high vaccination rates generally.” That offers opportunities to restore normalcy and “respond to new variants that will inevitably emerge without reinstalling the kind of disruptive measures that we needed before,” he said. Can the pandemic ceasefire bring enduring peace? “This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace,” he said. But he insisted that his message does not contradict those coming from Geneva, either, where WHO’s Director General Tedros Adhanom Ghebreyesus urged caution in reopening economies at a briefing earlier in the week. “The pandemic is not over, as Dr Tedros is rightly saying.” In particular, vaccination rates need to be pushed higher in undercovered parts of the Europe – as well as worldwide – to expand protection against the emergence of still newer, and potentially more dangerous variants, Kluge stressed. “It is because we see the opportunity that the top priority is to bring all countries to a level of protection which allows them to grasp this opportunity and look ahead towards more stable days “And that means that we need a drastic and uncompromising increase in vaccine-sharing.” For instance, while 66% of people across WHO’s vast European region have received a second vaccine dose, the numbers go as high as 70% in high income countries – where 40% of the population also has boosters, said Oleg Benes, another WHO European region official. But in the region’s lower middle income countries, rates remain much lower. “Booster courses are just starting to roll out.” Vaccine rates are as low as 30% in some countries, with only one in 3 older adults, on average protected.” That, he admitted, is also due in part to higher rates of vaccine hesitation among older people in some countries. Inconsistent vaccination coverage in the Americas ‘worrisome’ Similar inconsistencies in vaccination coverage prevail in the Americas – where average vaccination rates are also 60% or more. And that remains a “worrisome sign”, said Etienne. That is particularly true as the Americas region overall is still seeing rising rates of the Omicron variant – even while Europe seems to have turned the corner. While 14 countries and territories have immunized 70% of their populations, the same number of countries have yet to protect 40% of their people. More than 25% of people across the region have yet to receive a single dose of protection – rising to 54% in low- and middle-income countries, PAHO officials said. As in other parts of the world, countries that have experienced civil conflict, unrest and natural disasters lag even further behind. Haiti, notably, has less than 1% of its population fully vaccinated against COVID-19. The country began its vaccine drive late last year, having only received donations from donors such as the WHO-co sponsored COVAX initiative in July. Jamaica also is behind in its vaccinations – with only 21% of people fully vaccinated. Meanwhile, COVID-related deaths have increased for the fourth consecutive week in all subregions of north and south America and the Caribbean, with an increase of 33% last week over the week previous. That, officials added, further underscores the impacts of uneven vaccination rates – which continue to leave unvaccinated older and more vulnerable groups more prone to serious disease. Image Credits: Daily Caller/Twitter , Radio Metropolitana Cuba/Twitter . In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. 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Two Years into COVID Pandemic, 92 % of Countries Still Face Significant Health Service Disruptions 08/02/2022 Maayan Hoffman Healthcare workers in Nigeria have struggled to maintain routine childhood vaccination services during the COVID-19 pandemic. Two years after the COVID-19 pandemic began, over ninety percent of countries continue to face ongoing disruptions to their health systems, according to a survey published Monday evening by the World Health Organization. The WHO Global Pulse Survey, the third of its kind since the start of the COVID-19 crisis, analysed responses from 129 countries, territories and areas on the continuity of essential health services in the latter part of 2021. The aim, WHO said, is to gain insights into the impact of the pandemic on these services and related changes that countries could be facing. At the end of the year, disruptions were occuring across practically every sector of health services – and at roughly the same rates as the first quarter of 2021, when vaccines were not yet widely available, found the survey, which covered both high, middle and lower income countries. “Findings from this latest survey, conducted at the end of 2021, suggest that health systems in all regions and in countries of all income levels continue to be severely impacted, with little to no improvement since early 2021, when the previous survey was conducted,” stated a WHO press statement. Strikingly, health workforce issues were found to be the biggest barrier to scaling up access to COVID-19 testing, treatment and vaccination. WHO said this is likely a result of staff exhaustion, workforce infections, and health workers leaving their jobs due to the stress of the pandemic. More than a third (35%) of countries reported health workforce challenges more broadly beyond the bottlenecks in COVID-related healthcare services. Disruptions across all major areas of healthcare services In terms of other challenges, countries reported disruptions across all major health areas: sexual, reproductive, maternal, newborn, child and adolescent health, immunization, nutrition, cancer care, mental, neurological and substance use disorders, HIV, hepatitis, TB, malaria, neglected tropical diseases and care for older people. Moreover, at the same time that countries were scaling up their administration of COVID-19 vaccines, they reported increased disruptions in routine immunization services. More than half of the countries responding to the survey said that many people are still unable to access care at the primary care and community care levels. Elective surgeries were also disrupted in 59% of countries, which WHO said could have accumulating and long-term impact on personal health and well-being. Nearly one-third (32%) reported challenges accessing emergency room services. Some 66 core health services across multiple delivery platforms and health areas were included in the survey. Plans for recovery At the same time, countries have tried to further beef up their responses to adapt and rebound from the continuing crisis, including with the provision of more home care and telemedicine; stepped up healthworker recruitment and training; procurement of “surge commodities” and more public financial support for the delivery of certain services, such as COVID testing or vaccination, to ensure wider uptake. One-half of countries surveyed have developed a health service recovery plan to prepare for future health emergencies, and 70% of countries having allocated additional government funding to health workforce strengthening; access to medicines and other health products; digital health; facility infrastructure; and public engagement and communications. As the survey responses were gathered up to November 2021, the data does not reflect the complex impacts on health services of the Omicron wave – which hit in late November. That wave has infected unprecedented numbers of people in most countries around the world, including large numbers of healthcare workers. At the same time, hospitalization rates have been proportionately lower than past COVID waves. That allowed some countries to refocus efforts on other emergency and routine hospital procedures – although hospital capacity in other countries has been strained by surges in moderately and seriously ill COVID patients. The full report can be found here. Image Credits: Twitter: @WHOAFRO. Africa CDC is Elevated to Status of Continental Public Health Agency 07/02/2022 Paul Adepoju The African Union held its annual summit in Addis Ababa The African Union has decided to elevate its African Centres for Disease Control and Prevention (Africa CDC) to the status of an autonomous public health agency for the continent – rather than operating simply as technical arm of the AU. “Africa CDC will now be an autonomous health agency for the continent. Until now, Africa CDC was a specialized technical institution. It will now be elevated into a full public health agency for the continent, which will be more or less autonomous,” declared Dr John Nkengasong, Africa CDC’s director, on Sunday, the second day of the 35th AU summit that took place over the weekend in the Ethiopian capital of Addis Ababa. The elevation of the Africa CDC – which will now report directly to Heads of State of AU Member Countries – signals the growing member state commitment to strengthening the continent’s response to current and future disease outbreaks, he added. This development, Nkengasong said, is as a result of continent leaders’ renewed perception of disease as a security threat for the continent, in the wake of the COVID pandemic, among other disease trends. “They want to have full, timely access to anything that happens within the continent so that they can provide policy guidance. So I think that is extremely encouraging,” he added. Summit leaders also pledged their support for the full-fledged establishment of the African Medicines Agency (AMA); aggressively combating malaria and female genital mutilation; and a 2022 AU “Year of Nutrition” – which would aim to get the continent back on track towards achieving Sustainable Development Goals for nutrition – as well as for resilient agriculture. Africa CDC Director John Nkengasong Kenya calls on fellow heads of state to ‘sign up’ for AMA Treaty; Senegal is latest country to ratify The African Medicines Agency (AMA) treaty, which is now being backed by 30 African countries as previously reported by Health Policy Watch, was another major topic of discussion, with various calls by leaders and stakeholders for the agency to fully commence its operations soon. Senegal became the latest country to officially ratify the AMA treaty, while Kenya’s president hinted that the East African powerhouse Kenya could join soon. Addressing his fellow heads-of-state, President Uhuru Kenyatta issued a strong call to African leaders to “sign up as soon as possible for this initiative” – saying that once operational, it will be critical in keeping people on the continent safer from disease threats. “Several African countries have now signed the AMA treaty, enabling better access to newer, safer medicines. I urge my fellow heads of state to sign up as soon as possible for this initiative,” Kenyatta declared. At last month’s World Health Organization (WHO) executive board meeting, Kenya also expressed commitment to the AMA, in remarks made on behalf of the African bloc of WHO member states. Kenya’s President Uhuru Kenyatta speaking at the African Union’s 35th Summit Senegal’s move means that so far 22 countries have ratified the treaty, while eight more have signed it, for a total of 30 countries in formal support. Another 25 countries, including the economic and population powerhouses of Kenya, South Africa, Ethiopia and Nigeria have yet to sign or ratify the treaty instrument. See the countdown here: AMA countdown gauge Infogram Review of proposals for a host country for the new AMA institution are set to begin in April, with the first AMA Conference of State Parties (CoSP) set for May – where an assessment report will be presented for discussion on recommendations for a venue and next steps to establish the AMA. Malaria goals lag African Union media briefing on the Malaria Progress Report 2021, by Kenya’s President Uhuru Kenyatta and AU Health, Humanitarian & Social Affairs Commissioner Samate Cessouma Minata On malaria, the Malaria Progress Report 2021 underlined that the African continent is not on track to eliminate malaria by 2030. Africa continues to account for the lion’s share – 98% – of global malaria deaths. Out of the total of 611,802 malaria deaths that occurred on the continent in 2020, the report noted that about 49,000 of the deaths were attributed to disruptions to malaria programmes and broader health services caused by the COVID-19 pandemic. Addressing journalists at the summit, Kenya’s President Kenyatta, who also chairs the African Leaders Malaria Alliance said far-reaching strategies need to be adopted to eliminate malaria. “For us as a continent, we have attempted to fight malaria in the past but the disease is still a major threat to health and development in Africa,” Kenyatta said. However, he added that African countries are making progress in implementing a four-point legacy agenda of digitization and scorecard accountability and action plans; a multi-sectoral advocacy, action and resource mobilization; regional coordination and access to life-saving commodities. “Happy to report that we have made good progress in implementing the four-point agenda. Countries continue to expand the use of digital tools to strengthen evidence-based accountability and the fight against malaria. All countries are implementing national scorecard tools on malaria, reproductive, maternal, newborn and adolescent and child health care, neglected tropical disease, nutrition and community scorecards,” he added. See related Health Policy Watch story Digital Scorecards Provide Citizens with Information on Neglected Tropical Diseases Year of nutrition At the summit, AU’s plan to declare 2022 as the “Year of Nutrition” was also finalized. The plan notes that Covid-19 has greatly exposed the economic vulnerability of African countries, as well as the weaknesses of health and food systems. “With the COVID-19 pandemic, much of human capital gains in many economies over the past decade is at risk of being eroded. The price to pay for keeping the virus at bay has been, in many African countries, at the expense of gains made in reducing malnutrition,” the AU stated. Specifically, it noted that the prevalence of wasting will also increase due to higher risks of acute food insecurity. The plan calls for urgent action to recoup and build upon pre-pandemic gains made against undernutrition and malnutrition, including reducing childhood wasting (low weight relative to height) and stunting (low height relative to age). Stunting, a powerful indicator of undernutrition, still affects some 150.8 milllion children under the age of five, including 58.7 million African children. Currently only seven AU member states out of 55 have stunting rates below 19%, while only 15 member states have child wasting prevalence below 5%. SDG Goal 2 – Zero Hunger – calls for reducing the prevalence of stunting by 40% by 2025, in comparison to 2012 levels. “Investing in human capital is now more important than ever through designing the needed interventions especially targeting the most vulnerable,” the plan asserts. Africa remains the only continent with high levels of malnutrition & suffers slow progress to reverse the situation. Data from Continental Nutrition Accountability Scorecard indicates an increase in the number of stunted children from 50.6 million in 2000 to 58.7 million in 2017 pic.twitter.com/4n9chT6Vxx — African Union (@_AfricanUnion) February 7, 2022 Closing the Cancer Care Gap in Indigenous, Child, and Ageing Populations for World Cancer Day 04/02/2022 Raisa Santos Cancer statistics for the Maori people are very stark – 20% are more likely to develop cancer than non-Maori. For the indigenous people of New Zealand, the Māori, cancer statistics are bleak, as they are 20% more likely to develop cancer, and twice as likely as non-Māori to die from it. But New Zealand-based Cancer Control Agency, Te Aho o Te Kahu, is trying to beat back against this inequity and close the gap in care for Māori people. This story, and more, were among the many featured as part of World Cancer Day, a global initiative led by the Union for International Cancer Control (UICC) on 4 February. The theme for this year – ‘Close the Care Gap’ – addresses a need to address inequities in cancer care globally. This inequity has been even more pronounced in recent years, with the COVID-19 pandemic setting back treatment services and progress in many parts of the world. “We see [inequities] on a day to day basis, and they impact the chances of someone developing cancer in their lifetime, and also someone surviving cancer,” said UICC CEO Cary Adams. Featured speakers and experts from around the world – from New Zealand, Switzerland, Kuwait, the Philippines, and others, discussed ways to close the cancer care gap, including in ageing and indigenous populations, and told stories of cancer survivors. Engagement with indigenous groups necessary to address cancer care inequities in New Zealand Michelle Mako, Equity Director at Cancer Control Agency, New Zealand, Engagement is key to addressing the inequities surrounding cancer care, said Michelle Mako, Equity Director of the Cancer Control Agency. While exposure to risk factors such as smoking, alcohol, poor nutrition, lack of physical activity, and more drives up cancer incidence in Māori people, lack of access and lower utilization of primary care has also impacted cancer prevention and treatment. “Like many other nations, we are also seeing late detection of cancers in emergency departments, and we’re also seeing higher cancer rates with lower survival,” said Mako. To understand the gaps in care and potential solutions, Mako and the Cancer Control Agency spoke to around 2800 Māori with lived experiences of cancer in their families, as well as providers in the community. New Zealand is also going through a series of health reforms, one of which will incorporate a new agency for the Maori people – the Māori Health Authority, which will work with the NZ Ministry of Health and other local health agencies to ensure equitable access to care for the Maori. Looking forward, Mako hopes that equity is achieved with cancer care in New Zealand, especially with these initiatives and more. “I’d like to think that equity stops being a vague promise to do better or a fancy job title. I really hope that delivery equity just becomes standard practice and part of normal cancer care in the future.” Translating cancer care to aging populations Colon cancer rehabilitation trials in the UK. Quality of care is important in cancer care for ageing populations. With the number of people 60 years and older to double in the next twenty years, and with cancer cases already impacting 37% of the elderly – a number that will also undoubtedly rise in the next twenty years, it is crucial that cancer care also address the needs of ageing populations. “The cancer workforce is not always prepared to meet the complex needs of patients with cancer,” said Nicolo Battisti, President-Elect of the International Society of Geriatric Oncology. Currently, in some parts of the world, there are few geriatric oncology clinics that are able to provide comprehensive care to these patients. Older people with cancer also tend to be excluded more frequently from innovative clinical trials. But Rania Azmi, President of the Kuwait-based Fadia Survive and Thrive Cancer Association, has created an initiative centered around nine pillars that focus on meaningful discussion about elderly patients with cancer and patient-centered care in order to bring light to this issue. Rania Azmi, left and Nicolo Battisti, right One of the pillars considers the issue of functional age as opposed to chronological age for cancer patients, which makes all the difference for treatment. “It’s not just the number – 60 or 70 or 80 that defines who’s at risk for cancer. It’s organ function,” said Azmi. Elderly patients also experience different cognitive changes and pain when it comes to cancer, so all knowledge and cancer control, including prevention, early detection, diagnosis, treatment, and even palliative care and quality of life, must be translated into actions to address their needs. “It’s really beyond oncology. To achieve [quality of care in elderly cancer patients] we need to hear the patient’s voice and have inclusion of patient decision in treatment,” Azmi noted. Providing financial and psychosocial support to child cancer patients in the Philippines The Kythe Foundation of the Philippines works with families and children with chronic illnesses. Children and younger populations also have difficulties in accessing quality care, especially in the Philippines, according to Philippines-based Kythe Foundation co-founder and Executive Director Maria Fatima Garcia-Lorenzo. The Kythe Foundation provides both psychosocial support and family support to children and families with chronic illness. ‘Adopted’ patients are also given full financial support – medicines, transportation, money for clean water – so that they can have a greater chance of surviving cancer. To celebrate their 30th anniversary, the foundation hosted a webinar in conversation with older cancer survivors and younger survivors, where they found striking differences in accessing treatment. “Our younger survivors had to really strive and line up to get financial help [for care]. They were not even diagnosed right away and had to go from one hospital to another to get proper diagnosis,” said Garcia-Lorenzo. Maria Fatima Garcia-Lorenzo, Kythe Foundation One survivor, according to Garcia-Lorenzo, did not even initially know what cancer was, causing him great fear and preventing him from complying with treatment. “You could see the disparities, the inequities of the health system – the haves and the have-nots. Everyone should have access to treatment, medicine, and information.” The Kythe Foundation is already pushing for more funding from the Philippine government, health departments, and insurance agencies to provide for the needs of cancer patients. Image Credits: einalem, World Cancer Day , Queen's University/Flickr, PTVph/Twitter . Africa Has Enough COVID Test Kits – Nkengasong 04/02/2022 Paul Adepoju Africa CDC director John Nkengasong Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC) has told Health Policy Watch that the continent is not in short supply of COVID-19 test kits. According to him, every African country that is in need of the test supplies can get it if they want. An open letter dated 31 January that was written by concerned members of civil society, clinicians, advocates, and communities affected by COVID-19, to the World Health Organization (WHO) urged it to rapidly recommend self-testing for COVID-19. While calling on the global health body to expedite the finalisation and release of a self-testing guideline for SARS-CoV-2 infection that includes a strong recommendation in favour of widespread access to self-testing, they noted that low- and middle-income countries (LMICs) represent nearly 85% of the global population but that only 40% of tests for COVID-19 have been used in LMICs. “As a result, the reported average daily testing rate of high-income countries is, per capita, nearly 10 times higher than that of middle-income countries and close to 100 times higher than that of low-income countries,” the letter stated. In Africa, according to the experts, citing WHO AFRO region, said 85% of COVID-19 infections are going undetected. “This inequity in access to the diagnostic tools that trigger life-saving individual and public health measures is part of the same ‘medical apartheid’ that has plagued the rollout of COVID-19 vaccines,” the experts noted. But on Thursday, Nkengasong noted that Africa has seen a remarkable change and improvement in access to testing. “We are here in the middle of the African Union (AU) Summit and we are characterizing it as a COVID-free summit, which means every day we conduct testing on all the delegates, and those are thousands of people that are tested. We have not run out of tests,” Nkengasong said. He said if countries follow the guidelines that the Africa CDC has given them, they will be able to access testing. Prioritising testing at the country level He argued that the major determining factor for closing the COVID-19 testing gap in Africa is at the country level — enjoining governments to prioritise testing as a major cornerstone of their pandemic response. While the continent’s testing data fluctuates from one week to another, it does not suggest that the continent is in short supply of testing kits, he added, describing the trend as a reflection of the priorities of the governments concerned. “Testing will continue to be key. We see the test numbers fluctuate. Some weeks you have a very high increase in testing and then the following week you see a decrease. But that doesn’t necessarily reflect a lack of tests. Instead, he said the trend could suggest that countries actually engaged in testing or they are doing selective tests — “which most of the cases is about people who have symptoms or people that are trying to travel, not really systematic testing going on”. In May 2020, the WHO published criteria in which it described a positive rate of less than 5% as an indicator that the epidemic is under control in a country. While this data for several African countries is not available, available data showed positive rates on the African continent ranging from 0.64% in Rwanda to 37.4% in Tunisia. More Clarity on Negotiators to Take Forward WHO Pandemic ‘Instrument’ Talks 04/02/2022 Kerry Cullinan WHA’s Special Session resolved on 1 December 2021 to negotiate a new global pandemic instrument. Representatives from Brazil, Egypt, Japan, Netherlands, South Africa, and Thailand are to make up the World Health Organization (WHO) Intergovernmental Negotiating Body (INB) on a future pandemic instrument, according to Knowledge Ecology International. The countries each represent a different region of the WHO, namely Africa (South Africa), the Americas, known as the Pan-American Health Organisation (Brazil), the South-East Asian Region (Thailand), Europe (Netherlands), the Eastern Mediterranean (Egypt) and the Western Pacific (Japan). South Africa confirmed that it had been chosen to represent Africa at the INB at last week’s WHO executive board meeting, while the European Union announced that it would be represented by an official from the Netherlands. Last year’s World Health Assembly (WHA) Special Session resolved to start intergovernmental negotiations “to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”. According to the WHA resolution, the first INB meeting shall be held no later than 1 March to “elect two co-chairs, reflecting a balance of developed and developing countries, and four vice-chairs, one from each of the six WHO regions” as well as “define and agree on its working methods and timelines”. The resolution also directs the INB to “first identify the substantive elements of the instrument and to then begin the development of a working draft to be presented, on the basis of progress achieved, for the consideration of the INB at its second meeting, to be held no later than 1 August 2022”. The INB has until the 77th WHA next year to present a draft of the instrument, but needs to present a progress report to this year’s WHA. Thirty African Countries Now Back Africa Medicines Agency Treaty But Continent’s Economic Powers Still Hold Out 03/02/2022 Paul Adepoju Ambassador Samate Cessouma Minata, AU Commissioner for Health, Humanitarian Affairs and Social Development (HHS) Some 21 countries have now ratified the African Medicines Agency treaty – well beyond the 15 ratifications reached in November 2021, which allowed the AMA treaty instrument to formally take effect. Egypt, Africa’s third most populous country, is the most recent state to have both ratified and deposited the treaty – marking a significant milestone in the efforts to get the continent’s bigger players on board. Altogether, 19 African countries have both ratified and deposited the AMA treaty instrument to the AU secretariat, said Cessouma Minata Samate, African Union Commissioner for Health, Humanitarian Affairs and Social Development, at a press briefing on Thursday. She was speaking at a briefing on the margins of the 35th African Union Summit, which takes place this weekend. Two more countries, Morocco and Saharawi, have also ratified the treaty – but are yet to deposit it – rounding out the 21. Another nine countries have signed the treaty, but are yet to ratify it – including Equatorial Guinea and Comoros, which signed over just the past week, said Samate. All in all, that makes for a total of 30 countries that are formally on board with the treaty through signature, ratification, or both – while 25 still remain uncommitted. The new agency is supposed to provide a streamlined regulatory authority that would improve quality medicines access, and combat substandard imports, backers say. “The AMA will also guide the regulation of medicines, and facilitate access to quality medicines on the continent,” underlined Samate. Africa’s biggest economies still hold out Despite that promise, the 25 countries that have not yet signed the treaty include most of Africa’s population and economic powerhouses — such as Nigeria, South Africa, Kenya and Ethiopia. Responding to queries regarding the fence-sitters, Samate deferred, attributing the delays to variations in respective countries’ signing and ratification procedures. “I do not want to answer why Ethiopia did not sign; I am not part of the government. But each country has its procedure. There are several procedures involved. There is a whole process for it to arrive at the Parliament which will ratify it, and it depends on each country,” she said. “Each country has its rules for signing and ratifying treaties,” she said. She however added that since the treaty is new, sufficient time has to be given to Member States to sign and ratify it. Ultimately, however, all member states recognise it is in the best interest of citizens on the continent. “I am sure that all the countries are committed.” AMA will improve medicines regulation and access on the continent State of play as of 2 February in the alignment of 30 AU member states around the AMA treaty. Another 25 states have yet to sign or ratify. Samate noted that the AMA will be important in coordinating between the continent’s sub regional blocs, which have different economic alliances, also affecting trade and thereby medicines regulations. “The agency will coordinate the actors at the level of our subregional economic communities, and will work with AU Member States to enable us to have efficient health systems to treat our various populations.” “It’s important for us to have an agency for ourselves – to serve as a regulator for medicines issues on the continent,” she said. Others have emphasized that the AMA could help speed access to medicines – by conducting reviews and issuing recommendations on new treatments, which could take counties much longer to tackle individually. And it could help bring down some medicines prices by facilitating regulatory harmonization – which permits more bulk imports. In addition, it is hoped that the agency can play a role in fighting substandard and fake medicines. Currently WHO’s African Region suffers from the highest rates of reports of fake and substandard medicines in the world, according to both the WHO and AU officials. Timeline for setting up the new agency The next step in transforming the AMA from a treaty to an actual institution is to decide on a host country for the agency’s headquarters, Samate told journalists. This is not expected to be completed at the AU Summit – insofar as the criteria and process are yet to be announced. But she affirmed that the process would get underway “very shortly.” “There will be a process to allow the member states to decide, very shortly, which African country will host the AMA,” she told journalists. Sources, however, told Health Policy Watch that the process of assessing countries vying to host the AMA may not really begin until April. However an initial meeting of the AMA Conference of State Parties (CoSP) is scheduled for May – where an assessment report will be presented for discussion on recommendations for AMA host country. Following that, the terms of reference for the AMA Director-General will then be considered by the CoSP – to pave the way for recruitment of an agency head. Lastly, the site for the proposed AMA headquarters is expected to be adopted by the AU Assembly to be held in July 2022. Meeting ambitious goals The AMA treaty document was first approved by the African Union in 2019. At a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda in December 2021, panellists described the AMA as critical to Africa achieving the set goal of producing 60% of vaccines on its own soil by 2040. Ahead of the African Union Summit held over the past weekend, the African Medicines Agency Treaty Alliance (AMATA), an alliance that represents patients, academia, civil society, and industry set up to advocate for the ratification and implementation of the AMA, applauded the momentum reached so far. As the 35th #AUSummit takes place, we as #AMATA members call on the @_AfricanUnion to now prepare for the practical implementation of the Treaty establishing the #AfricanMedicinesAgency, bringing Africa🌍a step closer to having a continent-wide regulatory agency! pic.twitter.com/x8K1aORGZN — IAPO (@IAPOvoice) February 4, 2022 They called for a set of key steps to be taken in order to operationalise the Agency, including setting up a secretariat and choosing its location, adequate human resource capacity to operationalise its mandate and a sustainable funding model to ensure short- and long-term stability. AMATA also stressed the importance of recognizing patients as key partners in the development of the Agency – as part of a framework of engagement with non-state actors, including academia, research bodies, private sector and other civil society groups. They also appealed to all other African countries to ratify the AMA to “strengthen the continent’s capacity and preparedness to deal with future pandemics”, foster a spirit of cooperation to enable the development of medicines and vaccines, and safeguard the health of the continent and to protect citizens of Africa from fake m. Image Credits: African Union . Cancer Services and Routine Immunizations Backlogged – as Some Countries Anticipate Pandemic ‘Ceasefire’ – WHO 03/02/2022 Elaine Ruth Fletcher & Raisa Santos Hans Kluge, WHO European Regional Director Cancer services remain backlogged in many parts of the world due to the effects of the two-year-long COVID pandemic – even as Europe hopes a pandemic “ceasefire that could bring us enduring peace” , said WHO’s European Regional Director Hans Kluge Thursday on the eve of World Cancer Day. Meanwhile, in Latin America, routine childhood immunizations are down by around 10% as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases, said Carissa Etienne, Regional Director of the Pan American Health Organization in a briefing Wednesday evening. Both WHO regions, which include some of the world’s highest income countries, as well as middle income nations, alongside low-income states, continue to face striking regional imbalances in vaccine distribution, top officials in the two regions also stress – with some countries reaching 70% COVID vaccine countries or more – while others only have reached about 30% of eligible adults with jabs, both Etienne and Kluge stressed in separate press briefings. And that still leaves some countries disproportionately vulnerable to the ongoing effects of the Omicron variant – as well as to risks of new emerging variants. Cancer – knock-on effects will last for years Cancer services were disrupted up to 50% in the WHO Europe region. The two-year ongoing pandemic has had “catastrophic” effects on people with cancer, said Kluge, in his remarks – “going far beyond the disease itself.” One in four people in WHO’s European Region will receive a cancer diagnosis at some point in their lives – and cancer accounts for more than 20% of morbidity and mortality in the WHO region that extends from the Central Asian republics to the United Kingdom, he noted. In the European region, cancer diagnosis and treatment services saw disruptions of up to 50% in the early stages of the pandemic he noted. And while many EU countries have since rebounded, the picture remains uneven regionally and around the world. The latest WHO Global Pulse survey on disruptions in essential health service found that in the last quarter of 2021, countries worldwide were still experiencing disruptions in cancer screening and treatment services of between 5-50%, Kluge said. “The knock-on effects of this disruption will be felt for years,” Kluge added, noting that 44% of countries worldwide were reporting backlogs in cancer screening in the second half of 2021. Any post-Omicron ‘respite’ must be used to restore other essential health services Problems are compounded, he added, by the fact that the “health workforce is overstretched and exhausted – after being repurposed to address the direct impact of the virus. “Any respite the widespread immunity provides, thanks to vaccination and in the wake of the less severe Omicron, together with the coming spring and summer season, must be used immediately to enable health workers to return to other important health care functions, in order to bring backlogs for chronic care services down. “As we go forward, maintenance of essential health services, including services along the journey of cancer care, from prevention, early detection, diagnosis, treatment and quality of care will be a component of emergency planning and response,” he said. Americas also struggling to overcome disruptions in routine childhood vaccinations A child receives a routine vaccination in Cuba, which is a world leader in childhood immunization. Meanwhile, speaking from Washington DC, PAHO’s Etienne sounded a similar theme. But her message was focused around pandemic-related setbacks in childhood vaccinations across the WHO’s Americas’ region – which includes the affluent USA and Canada, alongside high, middle and low income countries of Latin America and the Caribbean. Routine childhood vaccinations for a third dose of diphtheria, tetanus, pertussis (DTP) vaccine has declined by 10% in the region, as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases because of lower immunization coverage, she said: “Despite the tremendous achievements of immunization programs in past decades, that progress has stalled in some countries, and has even reversed in this region.” Carissa Etienne, Director of the Pan American Health Organization/WHO Region of the Americas While the goal was to fully cover at least 95% of eligible children in 2020 with the DTP vaccine, 26 countries and territories of the Americas did not reach that goal. And some 14 countries in the region had particularly low coverage with the third dose – of 10% or less. As in Europe, she attributed the setbacks to the reassignment of healthcare professionals from primary care centers to hospitals and intensive care units – alongside public hesitations about getting vaccinated during the pandemic. PAHO is currently working with Ministries of Health across the Americas to revitalize family immunization programs as one of their “highest priorities”. “We are at a juncture where it is urgent to look at routine immunization programs,” said Etienne. As countries reopen – uneven vaccination coverage exacerbates future variant risks Both Europe and the Americas also are facing major inconsistencies in vaccine coverage rates within countries of the region, the officials also noted. And that poses additional risks as countries relax restrictions, Kluge stressed. “We in the European region have a unique situation,” Kluge said. “Once the Omicron wave has subsided, there will be a large capital of [SARS-CoV2] immunity, due to the infection in general, and quite high vaccination rates generally.” That offers opportunities to restore normalcy and “respond to new variants that will inevitably emerge without reinstalling the kind of disruptive measures that we needed before,” he said. Can the pandemic ceasefire bring enduring peace? “This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace,” he said. But he insisted that his message does not contradict those coming from Geneva, either, where WHO’s Director General Tedros Adhanom Ghebreyesus urged caution in reopening economies at a briefing earlier in the week. “The pandemic is not over, as Dr Tedros is rightly saying.” In particular, vaccination rates need to be pushed higher in undercovered parts of the Europe – as well as worldwide – to expand protection against the emergence of still newer, and potentially more dangerous variants, Kluge stressed. “It is because we see the opportunity that the top priority is to bring all countries to a level of protection which allows them to grasp this opportunity and look ahead towards more stable days “And that means that we need a drastic and uncompromising increase in vaccine-sharing.” For instance, while 66% of people across WHO’s vast European region have received a second vaccine dose, the numbers go as high as 70% in high income countries – where 40% of the population also has boosters, said Oleg Benes, another WHO European region official. But in the region’s lower middle income countries, rates remain much lower. “Booster courses are just starting to roll out.” Vaccine rates are as low as 30% in some countries, with only one in 3 older adults, on average protected.” That, he admitted, is also due in part to higher rates of vaccine hesitation among older people in some countries. Inconsistent vaccination coverage in the Americas ‘worrisome’ Similar inconsistencies in vaccination coverage prevail in the Americas – where average vaccination rates are also 60% or more. And that remains a “worrisome sign”, said Etienne. That is particularly true as the Americas region overall is still seeing rising rates of the Omicron variant – even while Europe seems to have turned the corner. While 14 countries and territories have immunized 70% of their populations, the same number of countries have yet to protect 40% of their people. More than 25% of people across the region have yet to receive a single dose of protection – rising to 54% in low- and middle-income countries, PAHO officials said. As in other parts of the world, countries that have experienced civil conflict, unrest and natural disasters lag even further behind. Haiti, notably, has less than 1% of its population fully vaccinated against COVID-19. The country began its vaccine drive late last year, having only received donations from donors such as the WHO-co sponsored COVAX initiative in July. Jamaica also is behind in its vaccinations – with only 21% of people fully vaccinated. Meanwhile, COVID-related deaths have increased for the fourth consecutive week in all subregions of north and south America and the Caribbean, with an increase of 33% last week over the week previous. That, officials added, further underscores the impacts of uneven vaccination rates – which continue to leave unvaccinated older and more vulnerable groups more prone to serious disease. Image Credits: Daily Caller/Twitter , Radio Metropolitana Cuba/Twitter . In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. 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Africa CDC is Elevated to Status of Continental Public Health Agency 07/02/2022 Paul Adepoju The African Union held its annual summit in Addis Ababa The African Union has decided to elevate its African Centres for Disease Control and Prevention (Africa CDC) to the status of an autonomous public health agency for the continent – rather than operating simply as technical arm of the AU. “Africa CDC will now be an autonomous health agency for the continent. Until now, Africa CDC was a specialized technical institution. It will now be elevated into a full public health agency for the continent, which will be more or less autonomous,” declared Dr John Nkengasong, Africa CDC’s director, on Sunday, the second day of the 35th AU summit that took place over the weekend in the Ethiopian capital of Addis Ababa. The elevation of the Africa CDC – which will now report directly to Heads of State of AU Member Countries – signals the growing member state commitment to strengthening the continent’s response to current and future disease outbreaks, he added. This development, Nkengasong said, is as a result of continent leaders’ renewed perception of disease as a security threat for the continent, in the wake of the COVID pandemic, among other disease trends. “They want to have full, timely access to anything that happens within the continent so that they can provide policy guidance. So I think that is extremely encouraging,” he added. Summit leaders also pledged their support for the full-fledged establishment of the African Medicines Agency (AMA); aggressively combating malaria and female genital mutilation; and a 2022 AU “Year of Nutrition” – which would aim to get the continent back on track towards achieving Sustainable Development Goals for nutrition – as well as for resilient agriculture. Africa CDC Director John Nkengasong Kenya calls on fellow heads of state to ‘sign up’ for AMA Treaty; Senegal is latest country to ratify The African Medicines Agency (AMA) treaty, which is now being backed by 30 African countries as previously reported by Health Policy Watch, was another major topic of discussion, with various calls by leaders and stakeholders for the agency to fully commence its operations soon. Senegal became the latest country to officially ratify the AMA treaty, while Kenya’s president hinted that the East African powerhouse Kenya could join soon. Addressing his fellow heads-of-state, President Uhuru Kenyatta issued a strong call to African leaders to “sign up as soon as possible for this initiative” – saying that once operational, it will be critical in keeping people on the continent safer from disease threats. “Several African countries have now signed the AMA treaty, enabling better access to newer, safer medicines. I urge my fellow heads of state to sign up as soon as possible for this initiative,” Kenyatta declared. At last month’s World Health Organization (WHO) executive board meeting, Kenya also expressed commitment to the AMA, in remarks made on behalf of the African bloc of WHO member states. Kenya’s President Uhuru Kenyatta speaking at the African Union’s 35th Summit Senegal’s move means that so far 22 countries have ratified the treaty, while eight more have signed it, for a total of 30 countries in formal support. Another 25 countries, including the economic and population powerhouses of Kenya, South Africa, Ethiopia and Nigeria have yet to sign or ratify the treaty instrument. See the countdown here: AMA countdown gauge Infogram Review of proposals for a host country for the new AMA institution are set to begin in April, with the first AMA Conference of State Parties (CoSP) set for May – where an assessment report will be presented for discussion on recommendations for a venue and next steps to establish the AMA. Malaria goals lag African Union media briefing on the Malaria Progress Report 2021, by Kenya’s President Uhuru Kenyatta and AU Health, Humanitarian & Social Affairs Commissioner Samate Cessouma Minata On malaria, the Malaria Progress Report 2021 underlined that the African continent is not on track to eliminate malaria by 2030. Africa continues to account for the lion’s share – 98% – of global malaria deaths. Out of the total of 611,802 malaria deaths that occurred on the continent in 2020, the report noted that about 49,000 of the deaths were attributed to disruptions to malaria programmes and broader health services caused by the COVID-19 pandemic. Addressing journalists at the summit, Kenya’s President Kenyatta, who also chairs the African Leaders Malaria Alliance said far-reaching strategies need to be adopted to eliminate malaria. “For us as a continent, we have attempted to fight malaria in the past but the disease is still a major threat to health and development in Africa,” Kenyatta said. However, he added that African countries are making progress in implementing a four-point legacy agenda of digitization and scorecard accountability and action plans; a multi-sectoral advocacy, action and resource mobilization; regional coordination and access to life-saving commodities. “Happy to report that we have made good progress in implementing the four-point agenda. Countries continue to expand the use of digital tools to strengthen evidence-based accountability and the fight against malaria. All countries are implementing national scorecard tools on malaria, reproductive, maternal, newborn and adolescent and child health care, neglected tropical disease, nutrition and community scorecards,” he added. See related Health Policy Watch story Digital Scorecards Provide Citizens with Information on Neglected Tropical Diseases Year of nutrition At the summit, AU’s plan to declare 2022 as the “Year of Nutrition” was also finalized. The plan notes that Covid-19 has greatly exposed the economic vulnerability of African countries, as well as the weaknesses of health and food systems. “With the COVID-19 pandemic, much of human capital gains in many economies over the past decade is at risk of being eroded. The price to pay for keeping the virus at bay has been, in many African countries, at the expense of gains made in reducing malnutrition,” the AU stated. Specifically, it noted that the prevalence of wasting will also increase due to higher risks of acute food insecurity. The plan calls for urgent action to recoup and build upon pre-pandemic gains made against undernutrition and malnutrition, including reducing childhood wasting (low weight relative to height) and stunting (low height relative to age). Stunting, a powerful indicator of undernutrition, still affects some 150.8 milllion children under the age of five, including 58.7 million African children. Currently only seven AU member states out of 55 have stunting rates below 19%, while only 15 member states have child wasting prevalence below 5%. SDG Goal 2 – Zero Hunger – calls for reducing the prevalence of stunting by 40% by 2025, in comparison to 2012 levels. “Investing in human capital is now more important than ever through designing the needed interventions especially targeting the most vulnerable,” the plan asserts. Africa remains the only continent with high levels of malnutrition & suffers slow progress to reverse the situation. Data from Continental Nutrition Accountability Scorecard indicates an increase in the number of stunted children from 50.6 million in 2000 to 58.7 million in 2017 pic.twitter.com/4n9chT6Vxx — African Union (@_AfricanUnion) February 7, 2022 Closing the Cancer Care Gap in Indigenous, Child, and Ageing Populations for World Cancer Day 04/02/2022 Raisa Santos Cancer statistics for the Maori people are very stark – 20% are more likely to develop cancer than non-Maori. For the indigenous people of New Zealand, the Māori, cancer statistics are bleak, as they are 20% more likely to develop cancer, and twice as likely as non-Māori to die from it. But New Zealand-based Cancer Control Agency, Te Aho o Te Kahu, is trying to beat back against this inequity and close the gap in care for Māori people. This story, and more, were among the many featured as part of World Cancer Day, a global initiative led by the Union for International Cancer Control (UICC) on 4 February. The theme for this year – ‘Close the Care Gap’ – addresses a need to address inequities in cancer care globally. This inequity has been even more pronounced in recent years, with the COVID-19 pandemic setting back treatment services and progress in many parts of the world. “We see [inequities] on a day to day basis, and they impact the chances of someone developing cancer in their lifetime, and also someone surviving cancer,” said UICC CEO Cary Adams. Featured speakers and experts from around the world – from New Zealand, Switzerland, Kuwait, the Philippines, and others, discussed ways to close the cancer care gap, including in ageing and indigenous populations, and told stories of cancer survivors. Engagement with indigenous groups necessary to address cancer care inequities in New Zealand Michelle Mako, Equity Director at Cancer Control Agency, New Zealand, Engagement is key to addressing the inequities surrounding cancer care, said Michelle Mako, Equity Director of the Cancer Control Agency. While exposure to risk factors such as smoking, alcohol, poor nutrition, lack of physical activity, and more drives up cancer incidence in Māori people, lack of access and lower utilization of primary care has also impacted cancer prevention and treatment. “Like many other nations, we are also seeing late detection of cancers in emergency departments, and we’re also seeing higher cancer rates with lower survival,” said Mako. To understand the gaps in care and potential solutions, Mako and the Cancer Control Agency spoke to around 2800 Māori with lived experiences of cancer in their families, as well as providers in the community. New Zealand is also going through a series of health reforms, one of which will incorporate a new agency for the Maori people – the Māori Health Authority, which will work with the NZ Ministry of Health and other local health agencies to ensure equitable access to care for the Maori. Looking forward, Mako hopes that equity is achieved with cancer care in New Zealand, especially with these initiatives and more. “I’d like to think that equity stops being a vague promise to do better or a fancy job title. I really hope that delivery equity just becomes standard practice and part of normal cancer care in the future.” Translating cancer care to aging populations Colon cancer rehabilitation trials in the UK. Quality of care is important in cancer care for ageing populations. With the number of people 60 years and older to double in the next twenty years, and with cancer cases already impacting 37% of the elderly – a number that will also undoubtedly rise in the next twenty years, it is crucial that cancer care also address the needs of ageing populations. “The cancer workforce is not always prepared to meet the complex needs of patients with cancer,” said Nicolo Battisti, President-Elect of the International Society of Geriatric Oncology. Currently, in some parts of the world, there are few geriatric oncology clinics that are able to provide comprehensive care to these patients. Older people with cancer also tend to be excluded more frequently from innovative clinical trials. But Rania Azmi, President of the Kuwait-based Fadia Survive and Thrive Cancer Association, has created an initiative centered around nine pillars that focus on meaningful discussion about elderly patients with cancer and patient-centered care in order to bring light to this issue. Rania Azmi, left and Nicolo Battisti, right One of the pillars considers the issue of functional age as opposed to chronological age for cancer patients, which makes all the difference for treatment. “It’s not just the number – 60 or 70 or 80 that defines who’s at risk for cancer. It’s organ function,” said Azmi. Elderly patients also experience different cognitive changes and pain when it comes to cancer, so all knowledge and cancer control, including prevention, early detection, diagnosis, treatment, and even palliative care and quality of life, must be translated into actions to address their needs. “It’s really beyond oncology. To achieve [quality of care in elderly cancer patients] we need to hear the patient’s voice and have inclusion of patient decision in treatment,” Azmi noted. Providing financial and psychosocial support to child cancer patients in the Philippines The Kythe Foundation of the Philippines works with families and children with chronic illnesses. Children and younger populations also have difficulties in accessing quality care, especially in the Philippines, according to Philippines-based Kythe Foundation co-founder and Executive Director Maria Fatima Garcia-Lorenzo. The Kythe Foundation provides both psychosocial support and family support to children and families with chronic illness. ‘Adopted’ patients are also given full financial support – medicines, transportation, money for clean water – so that they can have a greater chance of surviving cancer. To celebrate their 30th anniversary, the foundation hosted a webinar in conversation with older cancer survivors and younger survivors, where they found striking differences in accessing treatment. “Our younger survivors had to really strive and line up to get financial help [for care]. They were not even diagnosed right away and had to go from one hospital to another to get proper diagnosis,” said Garcia-Lorenzo. Maria Fatima Garcia-Lorenzo, Kythe Foundation One survivor, according to Garcia-Lorenzo, did not even initially know what cancer was, causing him great fear and preventing him from complying with treatment. “You could see the disparities, the inequities of the health system – the haves and the have-nots. Everyone should have access to treatment, medicine, and information.” The Kythe Foundation is already pushing for more funding from the Philippine government, health departments, and insurance agencies to provide for the needs of cancer patients. Image Credits: einalem, World Cancer Day , Queen's University/Flickr, PTVph/Twitter . Africa Has Enough COVID Test Kits – Nkengasong 04/02/2022 Paul Adepoju Africa CDC director John Nkengasong Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC) has told Health Policy Watch that the continent is not in short supply of COVID-19 test kits. According to him, every African country that is in need of the test supplies can get it if they want. An open letter dated 31 January that was written by concerned members of civil society, clinicians, advocates, and communities affected by COVID-19, to the World Health Organization (WHO) urged it to rapidly recommend self-testing for COVID-19. While calling on the global health body to expedite the finalisation and release of a self-testing guideline for SARS-CoV-2 infection that includes a strong recommendation in favour of widespread access to self-testing, they noted that low- and middle-income countries (LMICs) represent nearly 85% of the global population but that only 40% of tests for COVID-19 have been used in LMICs. “As a result, the reported average daily testing rate of high-income countries is, per capita, nearly 10 times higher than that of middle-income countries and close to 100 times higher than that of low-income countries,” the letter stated. In Africa, according to the experts, citing WHO AFRO region, said 85% of COVID-19 infections are going undetected. “This inequity in access to the diagnostic tools that trigger life-saving individual and public health measures is part of the same ‘medical apartheid’ that has plagued the rollout of COVID-19 vaccines,” the experts noted. But on Thursday, Nkengasong noted that Africa has seen a remarkable change and improvement in access to testing. “We are here in the middle of the African Union (AU) Summit and we are characterizing it as a COVID-free summit, which means every day we conduct testing on all the delegates, and those are thousands of people that are tested. We have not run out of tests,” Nkengasong said. He said if countries follow the guidelines that the Africa CDC has given them, they will be able to access testing. Prioritising testing at the country level He argued that the major determining factor for closing the COVID-19 testing gap in Africa is at the country level — enjoining governments to prioritise testing as a major cornerstone of their pandemic response. While the continent’s testing data fluctuates from one week to another, it does not suggest that the continent is in short supply of testing kits, he added, describing the trend as a reflection of the priorities of the governments concerned. “Testing will continue to be key. We see the test numbers fluctuate. Some weeks you have a very high increase in testing and then the following week you see a decrease. But that doesn’t necessarily reflect a lack of tests. Instead, he said the trend could suggest that countries actually engaged in testing or they are doing selective tests — “which most of the cases is about people who have symptoms or people that are trying to travel, not really systematic testing going on”. In May 2020, the WHO published criteria in which it described a positive rate of less than 5% as an indicator that the epidemic is under control in a country. While this data for several African countries is not available, available data showed positive rates on the African continent ranging from 0.64% in Rwanda to 37.4% in Tunisia. More Clarity on Negotiators to Take Forward WHO Pandemic ‘Instrument’ Talks 04/02/2022 Kerry Cullinan WHA’s Special Session resolved on 1 December 2021 to negotiate a new global pandemic instrument. Representatives from Brazil, Egypt, Japan, Netherlands, South Africa, and Thailand are to make up the World Health Organization (WHO) Intergovernmental Negotiating Body (INB) on a future pandemic instrument, according to Knowledge Ecology International. The countries each represent a different region of the WHO, namely Africa (South Africa), the Americas, known as the Pan-American Health Organisation (Brazil), the South-East Asian Region (Thailand), Europe (Netherlands), the Eastern Mediterranean (Egypt) and the Western Pacific (Japan). South Africa confirmed that it had been chosen to represent Africa at the INB at last week’s WHO executive board meeting, while the European Union announced that it would be represented by an official from the Netherlands. Last year’s World Health Assembly (WHA) Special Session resolved to start intergovernmental negotiations “to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”. According to the WHA resolution, the first INB meeting shall be held no later than 1 March to “elect two co-chairs, reflecting a balance of developed and developing countries, and four vice-chairs, one from each of the six WHO regions” as well as “define and agree on its working methods and timelines”. The resolution also directs the INB to “first identify the substantive elements of the instrument and to then begin the development of a working draft to be presented, on the basis of progress achieved, for the consideration of the INB at its second meeting, to be held no later than 1 August 2022”. The INB has until the 77th WHA next year to present a draft of the instrument, but needs to present a progress report to this year’s WHA. Thirty African Countries Now Back Africa Medicines Agency Treaty But Continent’s Economic Powers Still Hold Out 03/02/2022 Paul Adepoju Ambassador Samate Cessouma Minata, AU Commissioner for Health, Humanitarian Affairs and Social Development (HHS) Some 21 countries have now ratified the African Medicines Agency treaty – well beyond the 15 ratifications reached in November 2021, which allowed the AMA treaty instrument to formally take effect. Egypt, Africa’s third most populous country, is the most recent state to have both ratified and deposited the treaty – marking a significant milestone in the efforts to get the continent’s bigger players on board. Altogether, 19 African countries have both ratified and deposited the AMA treaty instrument to the AU secretariat, said Cessouma Minata Samate, African Union Commissioner for Health, Humanitarian Affairs and Social Development, at a press briefing on Thursday. She was speaking at a briefing on the margins of the 35th African Union Summit, which takes place this weekend. Two more countries, Morocco and Saharawi, have also ratified the treaty – but are yet to deposit it – rounding out the 21. Another nine countries have signed the treaty, but are yet to ratify it – including Equatorial Guinea and Comoros, which signed over just the past week, said Samate. All in all, that makes for a total of 30 countries that are formally on board with the treaty through signature, ratification, or both – while 25 still remain uncommitted. The new agency is supposed to provide a streamlined regulatory authority that would improve quality medicines access, and combat substandard imports, backers say. “The AMA will also guide the regulation of medicines, and facilitate access to quality medicines on the continent,” underlined Samate. Africa’s biggest economies still hold out Despite that promise, the 25 countries that have not yet signed the treaty include most of Africa’s population and economic powerhouses — such as Nigeria, South Africa, Kenya and Ethiopia. Responding to queries regarding the fence-sitters, Samate deferred, attributing the delays to variations in respective countries’ signing and ratification procedures. “I do not want to answer why Ethiopia did not sign; I am not part of the government. But each country has its procedure. There are several procedures involved. There is a whole process for it to arrive at the Parliament which will ratify it, and it depends on each country,” she said. “Each country has its rules for signing and ratifying treaties,” she said. She however added that since the treaty is new, sufficient time has to be given to Member States to sign and ratify it. Ultimately, however, all member states recognise it is in the best interest of citizens on the continent. “I am sure that all the countries are committed.” AMA will improve medicines regulation and access on the continent State of play as of 2 February in the alignment of 30 AU member states around the AMA treaty. Another 25 states have yet to sign or ratify. Samate noted that the AMA will be important in coordinating between the continent’s sub regional blocs, which have different economic alliances, also affecting trade and thereby medicines regulations. “The agency will coordinate the actors at the level of our subregional economic communities, and will work with AU Member States to enable us to have efficient health systems to treat our various populations.” “It’s important for us to have an agency for ourselves – to serve as a regulator for medicines issues on the continent,” she said. Others have emphasized that the AMA could help speed access to medicines – by conducting reviews and issuing recommendations on new treatments, which could take counties much longer to tackle individually. And it could help bring down some medicines prices by facilitating regulatory harmonization – which permits more bulk imports. In addition, it is hoped that the agency can play a role in fighting substandard and fake medicines. Currently WHO’s African Region suffers from the highest rates of reports of fake and substandard medicines in the world, according to both the WHO and AU officials. Timeline for setting up the new agency The next step in transforming the AMA from a treaty to an actual institution is to decide on a host country for the agency’s headquarters, Samate told journalists. This is not expected to be completed at the AU Summit – insofar as the criteria and process are yet to be announced. But she affirmed that the process would get underway “very shortly.” “There will be a process to allow the member states to decide, very shortly, which African country will host the AMA,” she told journalists. Sources, however, told Health Policy Watch that the process of assessing countries vying to host the AMA may not really begin until April. However an initial meeting of the AMA Conference of State Parties (CoSP) is scheduled for May – where an assessment report will be presented for discussion on recommendations for AMA host country. Following that, the terms of reference for the AMA Director-General will then be considered by the CoSP – to pave the way for recruitment of an agency head. Lastly, the site for the proposed AMA headquarters is expected to be adopted by the AU Assembly to be held in July 2022. Meeting ambitious goals The AMA treaty document was first approved by the African Union in 2019. At a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda in December 2021, panellists described the AMA as critical to Africa achieving the set goal of producing 60% of vaccines on its own soil by 2040. Ahead of the African Union Summit held over the past weekend, the African Medicines Agency Treaty Alliance (AMATA), an alliance that represents patients, academia, civil society, and industry set up to advocate for the ratification and implementation of the AMA, applauded the momentum reached so far. As the 35th #AUSummit takes place, we as #AMATA members call on the @_AfricanUnion to now prepare for the practical implementation of the Treaty establishing the #AfricanMedicinesAgency, bringing Africa🌍a step closer to having a continent-wide regulatory agency! pic.twitter.com/x8K1aORGZN — IAPO (@IAPOvoice) February 4, 2022 They called for a set of key steps to be taken in order to operationalise the Agency, including setting up a secretariat and choosing its location, adequate human resource capacity to operationalise its mandate and a sustainable funding model to ensure short- and long-term stability. AMATA also stressed the importance of recognizing patients as key partners in the development of the Agency – as part of a framework of engagement with non-state actors, including academia, research bodies, private sector and other civil society groups. They also appealed to all other African countries to ratify the AMA to “strengthen the continent’s capacity and preparedness to deal with future pandemics”, foster a spirit of cooperation to enable the development of medicines and vaccines, and safeguard the health of the continent and to protect citizens of Africa from fake m. Image Credits: African Union . Cancer Services and Routine Immunizations Backlogged – as Some Countries Anticipate Pandemic ‘Ceasefire’ – WHO 03/02/2022 Elaine Ruth Fletcher & Raisa Santos Hans Kluge, WHO European Regional Director Cancer services remain backlogged in many parts of the world due to the effects of the two-year-long COVID pandemic – even as Europe hopes a pandemic “ceasefire that could bring us enduring peace” , said WHO’s European Regional Director Hans Kluge Thursday on the eve of World Cancer Day. Meanwhile, in Latin America, routine childhood immunizations are down by around 10% as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases, said Carissa Etienne, Regional Director of the Pan American Health Organization in a briefing Wednesday evening. Both WHO regions, which include some of the world’s highest income countries, as well as middle income nations, alongside low-income states, continue to face striking regional imbalances in vaccine distribution, top officials in the two regions also stress – with some countries reaching 70% COVID vaccine countries or more – while others only have reached about 30% of eligible adults with jabs, both Etienne and Kluge stressed in separate press briefings. And that still leaves some countries disproportionately vulnerable to the ongoing effects of the Omicron variant – as well as to risks of new emerging variants. Cancer – knock-on effects will last for years Cancer services were disrupted up to 50% in the WHO Europe region. The two-year ongoing pandemic has had “catastrophic” effects on people with cancer, said Kluge, in his remarks – “going far beyond the disease itself.” One in four people in WHO’s European Region will receive a cancer diagnosis at some point in their lives – and cancer accounts for more than 20% of morbidity and mortality in the WHO region that extends from the Central Asian republics to the United Kingdom, he noted. In the European region, cancer diagnosis and treatment services saw disruptions of up to 50% in the early stages of the pandemic he noted. And while many EU countries have since rebounded, the picture remains uneven regionally and around the world. The latest WHO Global Pulse survey on disruptions in essential health service found that in the last quarter of 2021, countries worldwide were still experiencing disruptions in cancer screening and treatment services of between 5-50%, Kluge said. “The knock-on effects of this disruption will be felt for years,” Kluge added, noting that 44% of countries worldwide were reporting backlogs in cancer screening in the second half of 2021. Any post-Omicron ‘respite’ must be used to restore other essential health services Problems are compounded, he added, by the fact that the “health workforce is overstretched and exhausted – after being repurposed to address the direct impact of the virus. “Any respite the widespread immunity provides, thanks to vaccination and in the wake of the less severe Omicron, together with the coming spring and summer season, must be used immediately to enable health workers to return to other important health care functions, in order to bring backlogs for chronic care services down. “As we go forward, maintenance of essential health services, including services along the journey of cancer care, from prevention, early detection, diagnosis, treatment and quality of care will be a component of emergency planning and response,” he said. Americas also struggling to overcome disruptions in routine childhood vaccinations A child receives a routine vaccination in Cuba, which is a world leader in childhood immunization. Meanwhile, speaking from Washington DC, PAHO’s Etienne sounded a similar theme. But her message was focused around pandemic-related setbacks in childhood vaccinations across the WHO’s Americas’ region – which includes the affluent USA and Canada, alongside high, middle and low income countries of Latin America and the Caribbean. Routine childhood vaccinations for a third dose of diphtheria, tetanus, pertussis (DTP) vaccine has declined by 10% in the region, as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases because of lower immunization coverage, she said: “Despite the tremendous achievements of immunization programs in past decades, that progress has stalled in some countries, and has even reversed in this region.” Carissa Etienne, Director of the Pan American Health Organization/WHO Region of the Americas While the goal was to fully cover at least 95% of eligible children in 2020 with the DTP vaccine, 26 countries and territories of the Americas did not reach that goal. And some 14 countries in the region had particularly low coverage with the third dose – of 10% or less. As in Europe, she attributed the setbacks to the reassignment of healthcare professionals from primary care centers to hospitals and intensive care units – alongside public hesitations about getting vaccinated during the pandemic. PAHO is currently working with Ministries of Health across the Americas to revitalize family immunization programs as one of their “highest priorities”. “We are at a juncture where it is urgent to look at routine immunization programs,” said Etienne. As countries reopen – uneven vaccination coverage exacerbates future variant risks Both Europe and the Americas also are facing major inconsistencies in vaccine coverage rates within countries of the region, the officials also noted. And that poses additional risks as countries relax restrictions, Kluge stressed. “We in the European region have a unique situation,” Kluge said. “Once the Omicron wave has subsided, there will be a large capital of [SARS-CoV2] immunity, due to the infection in general, and quite high vaccination rates generally.” That offers opportunities to restore normalcy and “respond to new variants that will inevitably emerge without reinstalling the kind of disruptive measures that we needed before,” he said. Can the pandemic ceasefire bring enduring peace? “This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace,” he said. But he insisted that his message does not contradict those coming from Geneva, either, where WHO’s Director General Tedros Adhanom Ghebreyesus urged caution in reopening economies at a briefing earlier in the week. “The pandemic is not over, as Dr Tedros is rightly saying.” In particular, vaccination rates need to be pushed higher in undercovered parts of the Europe – as well as worldwide – to expand protection against the emergence of still newer, and potentially more dangerous variants, Kluge stressed. “It is because we see the opportunity that the top priority is to bring all countries to a level of protection which allows them to grasp this opportunity and look ahead towards more stable days “And that means that we need a drastic and uncompromising increase in vaccine-sharing.” For instance, while 66% of people across WHO’s vast European region have received a second vaccine dose, the numbers go as high as 70% in high income countries – where 40% of the population also has boosters, said Oleg Benes, another WHO European region official. But in the region’s lower middle income countries, rates remain much lower. “Booster courses are just starting to roll out.” Vaccine rates are as low as 30% in some countries, with only one in 3 older adults, on average protected.” That, he admitted, is also due in part to higher rates of vaccine hesitation among older people in some countries. Inconsistent vaccination coverage in the Americas ‘worrisome’ Similar inconsistencies in vaccination coverage prevail in the Americas – where average vaccination rates are also 60% or more. And that remains a “worrisome sign”, said Etienne. That is particularly true as the Americas region overall is still seeing rising rates of the Omicron variant – even while Europe seems to have turned the corner. While 14 countries and territories have immunized 70% of their populations, the same number of countries have yet to protect 40% of their people. More than 25% of people across the region have yet to receive a single dose of protection – rising to 54% in low- and middle-income countries, PAHO officials said. As in other parts of the world, countries that have experienced civil conflict, unrest and natural disasters lag even further behind. Haiti, notably, has less than 1% of its population fully vaccinated against COVID-19. The country began its vaccine drive late last year, having only received donations from donors such as the WHO-co sponsored COVAX initiative in July. Jamaica also is behind in its vaccinations – with only 21% of people fully vaccinated. Meanwhile, COVID-related deaths have increased for the fourth consecutive week in all subregions of north and south America and the Caribbean, with an increase of 33% last week over the week previous. That, officials added, further underscores the impacts of uneven vaccination rates – which continue to leave unvaccinated older and more vulnerable groups more prone to serious disease. Image Credits: Daily Caller/Twitter , Radio Metropolitana Cuba/Twitter . In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. 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Closing the Cancer Care Gap in Indigenous, Child, and Ageing Populations for World Cancer Day 04/02/2022 Raisa Santos Cancer statistics for the Maori people are very stark – 20% are more likely to develop cancer than non-Maori. For the indigenous people of New Zealand, the Māori, cancer statistics are bleak, as they are 20% more likely to develop cancer, and twice as likely as non-Māori to die from it. But New Zealand-based Cancer Control Agency, Te Aho o Te Kahu, is trying to beat back against this inequity and close the gap in care for Māori people. This story, and more, were among the many featured as part of World Cancer Day, a global initiative led by the Union for International Cancer Control (UICC) on 4 February. The theme for this year – ‘Close the Care Gap’ – addresses a need to address inequities in cancer care globally. This inequity has been even more pronounced in recent years, with the COVID-19 pandemic setting back treatment services and progress in many parts of the world. “We see [inequities] on a day to day basis, and they impact the chances of someone developing cancer in their lifetime, and also someone surviving cancer,” said UICC CEO Cary Adams. Featured speakers and experts from around the world – from New Zealand, Switzerland, Kuwait, the Philippines, and others, discussed ways to close the cancer care gap, including in ageing and indigenous populations, and told stories of cancer survivors. Engagement with indigenous groups necessary to address cancer care inequities in New Zealand Michelle Mako, Equity Director at Cancer Control Agency, New Zealand, Engagement is key to addressing the inequities surrounding cancer care, said Michelle Mako, Equity Director of the Cancer Control Agency. While exposure to risk factors such as smoking, alcohol, poor nutrition, lack of physical activity, and more drives up cancer incidence in Māori people, lack of access and lower utilization of primary care has also impacted cancer prevention and treatment. “Like many other nations, we are also seeing late detection of cancers in emergency departments, and we’re also seeing higher cancer rates with lower survival,” said Mako. To understand the gaps in care and potential solutions, Mako and the Cancer Control Agency spoke to around 2800 Māori with lived experiences of cancer in their families, as well as providers in the community. New Zealand is also going through a series of health reforms, one of which will incorporate a new agency for the Maori people – the Māori Health Authority, which will work with the NZ Ministry of Health and other local health agencies to ensure equitable access to care for the Maori. Looking forward, Mako hopes that equity is achieved with cancer care in New Zealand, especially with these initiatives and more. “I’d like to think that equity stops being a vague promise to do better or a fancy job title. I really hope that delivery equity just becomes standard practice and part of normal cancer care in the future.” Translating cancer care to aging populations Colon cancer rehabilitation trials in the UK. Quality of care is important in cancer care for ageing populations. With the number of people 60 years and older to double in the next twenty years, and with cancer cases already impacting 37% of the elderly – a number that will also undoubtedly rise in the next twenty years, it is crucial that cancer care also address the needs of ageing populations. “The cancer workforce is not always prepared to meet the complex needs of patients with cancer,” said Nicolo Battisti, President-Elect of the International Society of Geriatric Oncology. Currently, in some parts of the world, there are few geriatric oncology clinics that are able to provide comprehensive care to these patients. Older people with cancer also tend to be excluded more frequently from innovative clinical trials. But Rania Azmi, President of the Kuwait-based Fadia Survive and Thrive Cancer Association, has created an initiative centered around nine pillars that focus on meaningful discussion about elderly patients with cancer and patient-centered care in order to bring light to this issue. Rania Azmi, left and Nicolo Battisti, right One of the pillars considers the issue of functional age as opposed to chronological age for cancer patients, which makes all the difference for treatment. “It’s not just the number – 60 or 70 or 80 that defines who’s at risk for cancer. It’s organ function,” said Azmi. Elderly patients also experience different cognitive changes and pain when it comes to cancer, so all knowledge and cancer control, including prevention, early detection, diagnosis, treatment, and even palliative care and quality of life, must be translated into actions to address their needs. “It’s really beyond oncology. To achieve [quality of care in elderly cancer patients] we need to hear the patient’s voice and have inclusion of patient decision in treatment,” Azmi noted. Providing financial and psychosocial support to child cancer patients in the Philippines The Kythe Foundation of the Philippines works with families and children with chronic illnesses. Children and younger populations also have difficulties in accessing quality care, especially in the Philippines, according to Philippines-based Kythe Foundation co-founder and Executive Director Maria Fatima Garcia-Lorenzo. The Kythe Foundation provides both psychosocial support and family support to children and families with chronic illness. ‘Adopted’ patients are also given full financial support – medicines, transportation, money for clean water – so that they can have a greater chance of surviving cancer. To celebrate their 30th anniversary, the foundation hosted a webinar in conversation with older cancer survivors and younger survivors, where they found striking differences in accessing treatment. “Our younger survivors had to really strive and line up to get financial help [for care]. They were not even diagnosed right away and had to go from one hospital to another to get proper diagnosis,” said Garcia-Lorenzo. Maria Fatima Garcia-Lorenzo, Kythe Foundation One survivor, according to Garcia-Lorenzo, did not even initially know what cancer was, causing him great fear and preventing him from complying with treatment. “You could see the disparities, the inequities of the health system – the haves and the have-nots. Everyone should have access to treatment, medicine, and information.” The Kythe Foundation is already pushing for more funding from the Philippine government, health departments, and insurance agencies to provide for the needs of cancer patients. Image Credits: einalem, World Cancer Day , Queen's University/Flickr, PTVph/Twitter . Africa Has Enough COVID Test Kits – Nkengasong 04/02/2022 Paul Adepoju Africa CDC director John Nkengasong Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC) has told Health Policy Watch that the continent is not in short supply of COVID-19 test kits. According to him, every African country that is in need of the test supplies can get it if they want. An open letter dated 31 January that was written by concerned members of civil society, clinicians, advocates, and communities affected by COVID-19, to the World Health Organization (WHO) urged it to rapidly recommend self-testing for COVID-19. While calling on the global health body to expedite the finalisation and release of a self-testing guideline for SARS-CoV-2 infection that includes a strong recommendation in favour of widespread access to self-testing, they noted that low- and middle-income countries (LMICs) represent nearly 85% of the global population but that only 40% of tests for COVID-19 have been used in LMICs. “As a result, the reported average daily testing rate of high-income countries is, per capita, nearly 10 times higher than that of middle-income countries and close to 100 times higher than that of low-income countries,” the letter stated. In Africa, according to the experts, citing WHO AFRO region, said 85% of COVID-19 infections are going undetected. “This inequity in access to the diagnostic tools that trigger life-saving individual and public health measures is part of the same ‘medical apartheid’ that has plagued the rollout of COVID-19 vaccines,” the experts noted. But on Thursday, Nkengasong noted that Africa has seen a remarkable change and improvement in access to testing. “We are here in the middle of the African Union (AU) Summit and we are characterizing it as a COVID-free summit, which means every day we conduct testing on all the delegates, and those are thousands of people that are tested. We have not run out of tests,” Nkengasong said. He said if countries follow the guidelines that the Africa CDC has given them, they will be able to access testing. Prioritising testing at the country level He argued that the major determining factor for closing the COVID-19 testing gap in Africa is at the country level — enjoining governments to prioritise testing as a major cornerstone of their pandemic response. While the continent’s testing data fluctuates from one week to another, it does not suggest that the continent is in short supply of testing kits, he added, describing the trend as a reflection of the priorities of the governments concerned. “Testing will continue to be key. We see the test numbers fluctuate. Some weeks you have a very high increase in testing and then the following week you see a decrease. But that doesn’t necessarily reflect a lack of tests. Instead, he said the trend could suggest that countries actually engaged in testing or they are doing selective tests — “which most of the cases is about people who have symptoms or people that are trying to travel, not really systematic testing going on”. In May 2020, the WHO published criteria in which it described a positive rate of less than 5% as an indicator that the epidemic is under control in a country. While this data for several African countries is not available, available data showed positive rates on the African continent ranging from 0.64% in Rwanda to 37.4% in Tunisia. More Clarity on Negotiators to Take Forward WHO Pandemic ‘Instrument’ Talks 04/02/2022 Kerry Cullinan WHA’s Special Session resolved on 1 December 2021 to negotiate a new global pandemic instrument. Representatives from Brazil, Egypt, Japan, Netherlands, South Africa, and Thailand are to make up the World Health Organization (WHO) Intergovernmental Negotiating Body (INB) on a future pandemic instrument, according to Knowledge Ecology International. The countries each represent a different region of the WHO, namely Africa (South Africa), the Americas, known as the Pan-American Health Organisation (Brazil), the South-East Asian Region (Thailand), Europe (Netherlands), the Eastern Mediterranean (Egypt) and the Western Pacific (Japan). South Africa confirmed that it had been chosen to represent Africa at the INB at last week’s WHO executive board meeting, while the European Union announced that it would be represented by an official from the Netherlands. Last year’s World Health Assembly (WHA) Special Session resolved to start intergovernmental negotiations “to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”. According to the WHA resolution, the first INB meeting shall be held no later than 1 March to “elect two co-chairs, reflecting a balance of developed and developing countries, and four vice-chairs, one from each of the six WHO regions” as well as “define and agree on its working methods and timelines”. The resolution also directs the INB to “first identify the substantive elements of the instrument and to then begin the development of a working draft to be presented, on the basis of progress achieved, for the consideration of the INB at its second meeting, to be held no later than 1 August 2022”. The INB has until the 77th WHA next year to present a draft of the instrument, but needs to present a progress report to this year’s WHA. Thirty African Countries Now Back Africa Medicines Agency Treaty But Continent’s Economic Powers Still Hold Out 03/02/2022 Paul Adepoju Ambassador Samate Cessouma Minata, AU Commissioner for Health, Humanitarian Affairs and Social Development (HHS) Some 21 countries have now ratified the African Medicines Agency treaty – well beyond the 15 ratifications reached in November 2021, which allowed the AMA treaty instrument to formally take effect. Egypt, Africa’s third most populous country, is the most recent state to have both ratified and deposited the treaty – marking a significant milestone in the efforts to get the continent’s bigger players on board. Altogether, 19 African countries have both ratified and deposited the AMA treaty instrument to the AU secretariat, said Cessouma Minata Samate, African Union Commissioner for Health, Humanitarian Affairs and Social Development, at a press briefing on Thursday. She was speaking at a briefing on the margins of the 35th African Union Summit, which takes place this weekend. Two more countries, Morocco and Saharawi, have also ratified the treaty – but are yet to deposit it – rounding out the 21. Another nine countries have signed the treaty, but are yet to ratify it – including Equatorial Guinea and Comoros, which signed over just the past week, said Samate. All in all, that makes for a total of 30 countries that are formally on board with the treaty through signature, ratification, or both – while 25 still remain uncommitted. The new agency is supposed to provide a streamlined regulatory authority that would improve quality medicines access, and combat substandard imports, backers say. “The AMA will also guide the regulation of medicines, and facilitate access to quality medicines on the continent,” underlined Samate. Africa’s biggest economies still hold out Despite that promise, the 25 countries that have not yet signed the treaty include most of Africa’s population and economic powerhouses — such as Nigeria, South Africa, Kenya and Ethiopia. Responding to queries regarding the fence-sitters, Samate deferred, attributing the delays to variations in respective countries’ signing and ratification procedures. “I do not want to answer why Ethiopia did not sign; I am not part of the government. But each country has its procedure. There are several procedures involved. There is a whole process for it to arrive at the Parliament which will ratify it, and it depends on each country,” she said. “Each country has its rules for signing and ratifying treaties,” she said. She however added that since the treaty is new, sufficient time has to be given to Member States to sign and ratify it. Ultimately, however, all member states recognise it is in the best interest of citizens on the continent. “I am sure that all the countries are committed.” AMA will improve medicines regulation and access on the continent State of play as of 2 February in the alignment of 30 AU member states around the AMA treaty. Another 25 states have yet to sign or ratify. Samate noted that the AMA will be important in coordinating between the continent’s sub regional blocs, which have different economic alliances, also affecting trade and thereby medicines regulations. “The agency will coordinate the actors at the level of our subregional economic communities, and will work with AU Member States to enable us to have efficient health systems to treat our various populations.” “It’s important for us to have an agency for ourselves – to serve as a regulator for medicines issues on the continent,” she said. Others have emphasized that the AMA could help speed access to medicines – by conducting reviews and issuing recommendations on new treatments, which could take counties much longer to tackle individually. And it could help bring down some medicines prices by facilitating regulatory harmonization – which permits more bulk imports. In addition, it is hoped that the agency can play a role in fighting substandard and fake medicines. Currently WHO’s African Region suffers from the highest rates of reports of fake and substandard medicines in the world, according to both the WHO and AU officials. Timeline for setting up the new agency The next step in transforming the AMA from a treaty to an actual institution is to decide on a host country for the agency’s headquarters, Samate told journalists. This is not expected to be completed at the AU Summit – insofar as the criteria and process are yet to be announced. But she affirmed that the process would get underway “very shortly.” “There will be a process to allow the member states to decide, very shortly, which African country will host the AMA,” she told journalists. Sources, however, told Health Policy Watch that the process of assessing countries vying to host the AMA may not really begin until April. However an initial meeting of the AMA Conference of State Parties (CoSP) is scheduled for May – where an assessment report will be presented for discussion on recommendations for AMA host country. Following that, the terms of reference for the AMA Director-General will then be considered by the CoSP – to pave the way for recruitment of an agency head. Lastly, the site for the proposed AMA headquarters is expected to be adopted by the AU Assembly to be held in July 2022. Meeting ambitious goals The AMA treaty document was first approved by the African Union in 2019. At a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda in December 2021, panellists described the AMA as critical to Africa achieving the set goal of producing 60% of vaccines on its own soil by 2040. Ahead of the African Union Summit held over the past weekend, the African Medicines Agency Treaty Alliance (AMATA), an alliance that represents patients, academia, civil society, and industry set up to advocate for the ratification and implementation of the AMA, applauded the momentum reached so far. As the 35th #AUSummit takes place, we as #AMATA members call on the @_AfricanUnion to now prepare for the practical implementation of the Treaty establishing the #AfricanMedicinesAgency, bringing Africa🌍a step closer to having a continent-wide regulatory agency! pic.twitter.com/x8K1aORGZN — IAPO (@IAPOvoice) February 4, 2022 They called for a set of key steps to be taken in order to operationalise the Agency, including setting up a secretariat and choosing its location, adequate human resource capacity to operationalise its mandate and a sustainable funding model to ensure short- and long-term stability. AMATA also stressed the importance of recognizing patients as key partners in the development of the Agency – as part of a framework of engagement with non-state actors, including academia, research bodies, private sector and other civil society groups. They also appealed to all other African countries to ratify the AMA to “strengthen the continent’s capacity and preparedness to deal with future pandemics”, foster a spirit of cooperation to enable the development of medicines and vaccines, and safeguard the health of the continent and to protect citizens of Africa from fake m. Image Credits: African Union . Cancer Services and Routine Immunizations Backlogged – as Some Countries Anticipate Pandemic ‘Ceasefire’ – WHO 03/02/2022 Elaine Ruth Fletcher & Raisa Santos Hans Kluge, WHO European Regional Director Cancer services remain backlogged in many parts of the world due to the effects of the two-year-long COVID pandemic – even as Europe hopes a pandemic “ceasefire that could bring us enduring peace” , said WHO’s European Regional Director Hans Kluge Thursday on the eve of World Cancer Day. Meanwhile, in Latin America, routine childhood immunizations are down by around 10% as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases, said Carissa Etienne, Regional Director of the Pan American Health Organization in a briefing Wednesday evening. Both WHO regions, which include some of the world’s highest income countries, as well as middle income nations, alongside low-income states, continue to face striking regional imbalances in vaccine distribution, top officials in the two regions also stress – with some countries reaching 70% COVID vaccine countries or more – while others only have reached about 30% of eligible adults with jabs, both Etienne and Kluge stressed in separate press briefings. And that still leaves some countries disproportionately vulnerable to the ongoing effects of the Omicron variant – as well as to risks of new emerging variants. Cancer – knock-on effects will last for years Cancer services were disrupted up to 50% in the WHO Europe region. The two-year ongoing pandemic has had “catastrophic” effects on people with cancer, said Kluge, in his remarks – “going far beyond the disease itself.” One in four people in WHO’s European Region will receive a cancer diagnosis at some point in their lives – and cancer accounts for more than 20% of morbidity and mortality in the WHO region that extends from the Central Asian republics to the United Kingdom, he noted. In the European region, cancer diagnosis and treatment services saw disruptions of up to 50% in the early stages of the pandemic he noted. And while many EU countries have since rebounded, the picture remains uneven regionally and around the world. The latest WHO Global Pulse survey on disruptions in essential health service found that in the last quarter of 2021, countries worldwide were still experiencing disruptions in cancer screening and treatment services of between 5-50%, Kluge said. “The knock-on effects of this disruption will be felt for years,” Kluge added, noting that 44% of countries worldwide were reporting backlogs in cancer screening in the second half of 2021. Any post-Omicron ‘respite’ must be used to restore other essential health services Problems are compounded, he added, by the fact that the “health workforce is overstretched and exhausted – after being repurposed to address the direct impact of the virus. “Any respite the widespread immunity provides, thanks to vaccination and in the wake of the less severe Omicron, together with the coming spring and summer season, must be used immediately to enable health workers to return to other important health care functions, in order to bring backlogs for chronic care services down. “As we go forward, maintenance of essential health services, including services along the journey of cancer care, from prevention, early detection, diagnosis, treatment and quality of care will be a component of emergency planning and response,” he said. Americas also struggling to overcome disruptions in routine childhood vaccinations A child receives a routine vaccination in Cuba, which is a world leader in childhood immunization. Meanwhile, speaking from Washington DC, PAHO’s Etienne sounded a similar theme. But her message was focused around pandemic-related setbacks in childhood vaccinations across the WHO’s Americas’ region – which includes the affluent USA and Canada, alongside high, middle and low income countries of Latin America and the Caribbean. Routine childhood vaccinations for a third dose of diphtheria, tetanus, pertussis (DTP) vaccine has declined by 10% in the region, as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases because of lower immunization coverage, she said: “Despite the tremendous achievements of immunization programs in past decades, that progress has stalled in some countries, and has even reversed in this region.” Carissa Etienne, Director of the Pan American Health Organization/WHO Region of the Americas While the goal was to fully cover at least 95% of eligible children in 2020 with the DTP vaccine, 26 countries and territories of the Americas did not reach that goal. And some 14 countries in the region had particularly low coverage with the third dose – of 10% or less. As in Europe, she attributed the setbacks to the reassignment of healthcare professionals from primary care centers to hospitals and intensive care units – alongside public hesitations about getting vaccinated during the pandemic. PAHO is currently working with Ministries of Health across the Americas to revitalize family immunization programs as one of their “highest priorities”. “We are at a juncture where it is urgent to look at routine immunization programs,” said Etienne. As countries reopen – uneven vaccination coverage exacerbates future variant risks Both Europe and the Americas also are facing major inconsistencies in vaccine coverage rates within countries of the region, the officials also noted. And that poses additional risks as countries relax restrictions, Kluge stressed. “We in the European region have a unique situation,” Kluge said. “Once the Omicron wave has subsided, there will be a large capital of [SARS-CoV2] immunity, due to the infection in general, and quite high vaccination rates generally.” That offers opportunities to restore normalcy and “respond to new variants that will inevitably emerge without reinstalling the kind of disruptive measures that we needed before,” he said. Can the pandemic ceasefire bring enduring peace? “This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace,” he said. But he insisted that his message does not contradict those coming from Geneva, either, where WHO’s Director General Tedros Adhanom Ghebreyesus urged caution in reopening economies at a briefing earlier in the week. “The pandemic is not over, as Dr Tedros is rightly saying.” In particular, vaccination rates need to be pushed higher in undercovered parts of the Europe – as well as worldwide – to expand protection against the emergence of still newer, and potentially more dangerous variants, Kluge stressed. “It is because we see the opportunity that the top priority is to bring all countries to a level of protection which allows them to grasp this opportunity and look ahead towards more stable days “And that means that we need a drastic and uncompromising increase in vaccine-sharing.” For instance, while 66% of people across WHO’s vast European region have received a second vaccine dose, the numbers go as high as 70% in high income countries – where 40% of the population also has boosters, said Oleg Benes, another WHO European region official. But in the region’s lower middle income countries, rates remain much lower. “Booster courses are just starting to roll out.” Vaccine rates are as low as 30% in some countries, with only one in 3 older adults, on average protected.” That, he admitted, is also due in part to higher rates of vaccine hesitation among older people in some countries. Inconsistent vaccination coverage in the Americas ‘worrisome’ Similar inconsistencies in vaccination coverage prevail in the Americas – where average vaccination rates are also 60% or more. And that remains a “worrisome sign”, said Etienne. That is particularly true as the Americas region overall is still seeing rising rates of the Omicron variant – even while Europe seems to have turned the corner. While 14 countries and territories have immunized 70% of their populations, the same number of countries have yet to protect 40% of their people. More than 25% of people across the region have yet to receive a single dose of protection – rising to 54% in low- and middle-income countries, PAHO officials said. As in other parts of the world, countries that have experienced civil conflict, unrest and natural disasters lag even further behind. Haiti, notably, has less than 1% of its population fully vaccinated against COVID-19. The country began its vaccine drive late last year, having only received donations from donors such as the WHO-co sponsored COVAX initiative in July. Jamaica also is behind in its vaccinations – with only 21% of people fully vaccinated. Meanwhile, COVID-related deaths have increased for the fourth consecutive week in all subregions of north and south America and the Caribbean, with an increase of 33% last week over the week previous. That, officials added, further underscores the impacts of uneven vaccination rates – which continue to leave unvaccinated older and more vulnerable groups more prone to serious disease. Image Credits: Daily Caller/Twitter , Radio Metropolitana Cuba/Twitter . In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. 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Africa Has Enough COVID Test Kits – Nkengasong 04/02/2022 Paul Adepoju Africa CDC director John Nkengasong Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC) has told Health Policy Watch that the continent is not in short supply of COVID-19 test kits. According to him, every African country that is in need of the test supplies can get it if they want. An open letter dated 31 January that was written by concerned members of civil society, clinicians, advocates, and communities affected by COVID-19, to the World Health Organization (WHO) urged it to rapidly recommend self-testing for COVID-19. While calling on the global health body to expedite the finalisation and release of a self-testing guideline for SARS-CoV-2 infection that includes a strong recommendation in favour of widespread access to self-testing, they noted that low- and middle-income countries (LMICs) represent nearly 85% of the global population but that only 40% of tests for COVID-19 have been used in LMICs. “As a result, the reported average daily testing rate of high-income countries is, per capita, nearly 10 times higher than that of middle-income countries and close to 100 times higher than that of low-income countries,” the letter stated. In Africa, according to the experts, citing WHO AFRO region, said 85% of COVID-19 infections are going undetected. “This inequity in access to the diagnostic tools that trigger life-saving individual and public health measures is part of the same ‘medical apartheid’ that has plagued the rollout of COVID-19 vaccines,” the experts noted. But on Thursday, Nkengasong noted that Africa has seen a remarkable change and improvement in access to testing. “We are here in the middle of the African Union (AU) Summit and we are characterizing it as a COVID-free summit, which means every day we conduct testing on all the delegates, and those are thousands of people that are tested. We have not run out of tests,” Nkengasong said. He said if countries follow the guidelines that the Africa CDC has given them, they will be able to access testing. Prioritising testing at the country level He argued that the major determining factor for closing the COVID-19 testing gap in Africa is at the country level — enjoining governments to prioritise testing as a major cornerstone of their pandemic response. While the continent’s testing data fluctuates from one week to another, it does not suggest that the continent is in short supply of testing kits, he added, describing the trend as a reflection of the priorities of the governments concerned. “Testing will continue to be key. We see the test numbers fluctuate. Some weeks you have a very high increase in testing and then the following week you see a decrease. But that doesn’t necessarily reflect a lack of tests. Instead, he said the trend could suggest that countries actually engaged in testing or they are doing selective tests — “which most of the cases is about people who have symptoms or people that are trying to travel, not really systematic testing going on”. In May 2020, the WHO published criteria in which it described a positive rate of less than 5% as an indicator that the epidemic is under control in a country. While this data for several African countries is not available, available data showed positive rates on the African continent ranging from 0.64% in Rwanda to 37.4% in Tunisia. More Clarity on Negotiators to Take Forward WHO Pandemic ‘Instrument’ Talks 04/02/2022 Kerry Cullinan WHA’s Special Session resolved on 1 December 2021 to negotiate a new global pandemic instrument. Representatives from Brazil, Egypt, Japan, Netherlands, South Africa, and Thailand are to make up the World Health Organization (WHO) Intergovernmental Negotiating Body (INB) on a future pandemic instrument, according to Knowledge Ecology International. The countries each represent a different region of the WHO, namely Africa (South Africa), the Americas, known as the Pan-American Health Organisation (Brazil), the South-East Asian Region (Thailand), Europe (Netherlands), the Eastern Mediterranean (Egypt) and the Western Pacific (Japan). South Africa confirmed that it had been chosen to represent Africa at the INB at last week’s WHO executive board meeting, while the European Union announced that it would be represented by an official from the Netherlands. Last year’s World Health Assembly (WHA) Special Session resolved to start intergovernmental negotiations “to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”. According to the WHA resolution, the first INB meeting shall be held no later than 1 March to “elect two co-chairs, reflecting a balance of developed and developing countries, and four vice-chairs, one from each of the six WHO regions” as well as “define and agree on its working methods and timelines”. The resolution also directs the INB to “first identify the substantive elements of the instrument and to then begin the development of a working draft to be presented, on the basis of progress achieved, for the consideration of the INB at its second meeting, to be held no later than 1 August 2022”. The INB has until the 77th WHA next year to present a draft of the instrument, but needs to present a progress report to this year’s WHA. Thirty African Countries Now Back Africa Medicines Agency Treaty But Continent’s Economic Powers Still Hold Out 03/02/2022 Paul Adepoju Ambassador Samate Cessouma Minata, AU Commissioner for Health, Humanitarian Affairs and Social Development (HHS) Some 21 countries have now ratified the African Medicines Agency treaty – well beyond the 15 ratifications reached in November 2021, which allowed the AMA treaty instrument to formally take effect. Egypt, Africa’s third most populous country, is the most recent state to have both ratified and deposited the treaty – marking a significant milestone in the efforts to get the continent’s bigger players on board. Altogether, 19 African countries have both ratified and deposited the AMA treaty instrument to the AU secretariat, said Cessouma Minata Samate, African Union Commissioner for Health, Humanitarian Affairs and Social Development, at a press briefing on Thursday. She was speaking at a briefing on the margins of the 35th African Union Summit, which takes place this weekend. Two more countries, Morocco and Saharawi, have also ratified the treaty – but are yet to deposit it – rounding out the 21. Another nine countries have signed the treaty, but are yet to ratify it – including Equatorial Guinea and Comoros, which signed over just the past week, said Samate. All in all, that makes for a total of 30 countries that are formally on board with the treaty through signature, ratification, or both – while 25 still remain uncommitted. The new agency is supposed to provide a streamlined regulatory authority that would improve quality medicines access, and combat substandard imports, backers say. “The AMA will also guide the regulation of medicines, and facilitate access to quality medicines on the continent,” underlined Samate. Africa’s biggest economies still hold out Despite that promise, the 25 countries that have not yet signed the treaty include most of Africa’s population and economic powerhouses — such as Nigeria, South Africa, Kenya and Ethiopia. Responding to queries regarding the fence-sitters, Samate deferred, attributing the delays to variations in respective countries’ signing and ratification procedures. “I do not want to answer why Ethiopia did not sign; I am not part of the government. But each country has its procedure. There are several procedures involved. There is a whole process for it to arrive at the Parliament which will ratify it, and it depends on each country,” she said. “Each country has its rules for signing and ratifying treaties,” she said. She however added that since the treaty is new, sufficient time has to be given to Member States to sign and ratify it. Ultimately, however, all member states recognise it is in the best interest of citizens on the continent. “I am sure that all the countries are committed.” AMA will improve medicines regulation and access on the continent State of play as of 2 February in the alignment of 30 AU member states around the AMA treaty. Another 25 states have yet to sign or ratify. Samate noted that the AMA will be important in coordinating between the continent’s sub regional blocs, which have different economic alliances, also affecting trade and thereby medicines regulations. “The agency will coordinate the actors at the level of our subregional economic communities, and will work with AU Member States to enable us to have efficient health systems to treat our various populations.” “It’s important for us to have an agency for ourselves – to serve as a regulator for medicines issues on the continent,” she said. Others have emphasized that the AMA could help speed access to medicines – by conducting reviews and issuing recommendations on new treatments, which could take counties much longer to tackle individually. And it could help bring down some medicines prices by facilitating regulatory harmonization – which permits more bulk imports. In addition, it is hoped that the agency can play a role in fighting substandard and fake medicines. Currently WHO’s African Region suffers from the highest rates of reports of fake and substandard medicines in the world, according to both the WHO and AU officials. Timeline for setting up the new agency The next step in transforming the AMA from a treaty to an actual institution is to decide on a host country for the agency’s headquarters, Samate told journalists. This is not expected to be completed at the AU Summit – insofar as the criteria and process are yet to be announced. But she affirmed that the process would get underway “very shortly.” “There will be a process to allow the member states to decide, very shortly, which African country will host the AMA,” she told journalists. Sources, however, told Health Policy Watch that the process of assessing countries vying to host the AMA may not really begin until April. However an initial meeting of the AMA Conference of State Parties (CoSP) is scheduled for May – where an assessment report will be presented for discussion on recommendations for AMA host country. Following that, the terms of reference for the AMA Director-General will then be considered by the CoSP – to pave the way for recruitment of an agency head. Lastly, the site for the proposed AMA headquarters is expected to be adopted by the AU Assembly to be held in July 2022. Meeting ambitious goals The AMA treaty document was first approved by the African Union in 2019. At a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda in December 2021, panellists described the AMA as critical to Africa achieving the set goal of producing 60% of vaccines on its own soil by 2040. Ahead of the African Union Summit held over the past weekend, the African Medicines Agency Treaty Alliance (AMATA), an alliance that represents patients, academia, civil society, and industry set up to advocate for the ratification and implementation of the AMA, applauded the momentum reached so far. As the 35th #AUSummit takes place, we as #AMATA members call on the @_AfricanUnion to now prepare for the practical implementation of the Treaty establishing the #AfricanMedicinesAgency, bringing Africa🌍a step closer to having a continent-wide regulatory agency! pic.twitter.com/x8K1aORGZN — IAPO (@IAPOvoice) February 4, 2022 They called for a set of key steps to be taken in order to operationalise the Agency, including setting up a secretariat and choosing its location, adequate human resource capacity to operationalise its mandate and a sustainable funding model to ensure short- and long-term stability. AMATA also stressed the importance of recognizing patients as key partners in the development of the Agency – as part of a framework of engagement with non-state actors, including academia, research bodies, private sector and other civil society groups. They also appealed to all other African countries to ratify the AMA to “strengthen the continent’s capacity and preparedness to deal with future pandemics”, foster a spirit of cooperation to enable the development of medicines and vaccines, and safeguard the health of the continent and to protect citizens of Africa from fake m. Image Credits: African Union . Cancer Services and Routine Immunizations Backlogged – as Some Countries Anticipate Pandemic ‘Ceasefire’ – WHO 03/02/2022 Elaine Ruth Fletcher & Raisa Santos Hans Kluge, WHO European Regional Director Cancer services remain backlogged in many parts of the world due to the effects of the two-year-long COVID pandemic – even as Europe hopes a pandemic “ceasefire that could bring us enduring peace” , said WHO’s European Regional Director Hans Kluge Thursday on the eve of World Cancer Day. Meanwhile, in Latin America, routine childhood immunizations are down by around 10% as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases, said Carissa Etienne, Regional Director of the Pan American Health Organization in a briefing Wednesday evening. Both WHO regions, which include some of the world’s highest income countries, as well as middle income nations, alongside low-income states, continue to face striking regional imbalances in vaccine distribution, top officials in the two regions also stress – with some countries reaching 70% COVID vaccine countries or more – while others only have reached about 30% of eligible adults with jabs, both Etienne and Kluge stressed in separate press briefings. And that still leaves some countries disproportionately vulnerable to the ongoing effects of the Omicron variant – as well as to risks of new emerging variants. Cancer – knock-on effects will last for years Cancer services were disrupted up to 50% in the WHO Europe region. The two-year ongoing pandemic has had “catastrophic” effects on people with cancer, said Kluge, in his remarks – “going far beyond the disease itself.” One in four people in WHO’s European Region will receive a cancer diagnosis at some point in their lives – and cancer accounts for more than 20% of morbidity and mortality in the WHO region that extends from the Central Asian republics to the United Kingdom, he noted. In the European region, cancer diagnosis and treatment services saw disruptions of up to 50% in the early stages of the pandemic he noted. And while many EU countries have since rebounded, the picture remains uneven regionally and around the world. The latest WHO Global Pulse survey on disruptions in essential health service found that in the last quarter of 2021, countries worldwide were still experiencing disruptions in cancer screening and treatment services of between 5-50%, Kluge said. “The knock-on effects of this disruption will be felt for years,” Kluge added, noting that 44% of countries worldwide were reporting backlogs in cancer screening in the second half of 2021. Any post-Omicron ‘respite’ must be used to restore other essential health services Problems are compounded, he added, by the fact that the “health workforce is overstretched and exhausted – after being repurposed to address the direct impact of the virus. “Any respite the widespread immunity provides, thanks to vaccination and in the wake of the less severe Omicron, together with the coming spring and summer season, must be used immediately to enable health workers to return to other important health care functions, in order to bring backlogs for chronic care services down. “As we go forward, maintenance of essential health services, including services along the journey of cancer care, from prevention, early detection, diagnosis, treatment and quality of care will be a component of emergency planning and response,” he said. Americas also struggling to overcome disruptions in routine childhood vaccinations A child receives a routine vaccination in Cuba, which is a world leader in childhood immunization. Meanwhile, speaking from Washington DC, PAHO’s Etienne sounded a similar theme. But her message was focused around pandemic-related setbacks in childhood vaccinations across the WHO’s Americas’ region – which includes the affluent USA and Canada, alongside high, middle and low income countries of Latin America and the Caribbean. Routine childhood vaccinations for a third dose of diphtheria, tetanus, pertussis (DTP) vaccine has declined by 10% in the region, as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases because of lower immunization coverage, she said: “Despite the tremendous achievements of immunization programs in past decades, that progress has stalled in some countries, and has even reversed in this region.” Carissa Etienne, Director of the Pan American Health Organization/WHO Region of the Americas While the goal was to fully cover at least 95% of eligible children in 2020 with the DTP vaccine, 26 countries and territories of the Americas did not reach that goal. And some 14 countries in the region had particularly low coverage with the third dose – of 10% or less. As in Europe, she attributed the setbacks to the reassignment of healthcare professionals from primary care centers to hospitals and intensive care units – alongside public hesitations about getting vaccinated during the pandemic. PAHO is currently working with Ministries of Health across the Americas to revitalize family immunization programs as one of their “highest priorities”. “We are at a juncture where it is urgent to look at routine immunization programs,” said Etienne. As countries reopen – uneven vaccination coverage exacerbates future variant risks Both Europe and the Americas also are facing major inconsistencies in vaccine coverage rates within countries of the region, the officials also noted. And that poses additional risks as countries relax restrictions, Kluge stressed. “We in the European region have a unique situation,” Kluge said. “Once the Omicron wave has subsided, there will be a large capital of [SARS-CoV2] immunity, due to the infection in general, and quite high vaccination rates generally.” That offers opportunities to restore normalcy and “respond to new variants that will inevitably emerge without reinstalling the kind of disruptive measures that we needed before,” he said. Can the pandemic ceasefire bring enduring peace? “This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace,” he said. But he insisted that his message does not contradict those coming from Geneva, either, where WHO’s Director General Tedros Adhanom Ghebreyesus urged caution in reopening economies at a briefing earlier in the week. “The pandemic is not over, as Dr Tedros is rightly saying.” In particular, vaccination rates need to be pushed higher in undercovered parts of the Europe – as well as worldwide – to expand protection against the emergence of still newer, and potentially more dangerous variants, Kluge stressed. “It is because we see the opportunity that the top priority is to bring all countries to a level of protection which allows them to grasp this opportunity and look ahead towards more stable days “And that means that we need a drastic and uncompromising increase in vaccine-sharing.” For instance, while 66% of people across WHO’s vast European region have received a second vaccine dose, the numbers go as high as 70% in high income countries – where 40% of the population also has boosters, said Oleg Benes, another WHO European region official. But in the region’s lower middle income countries, rates remain much lower. “Booster courses are just starting to roll out.” Vaccine rates are as low as 30% in some countries, with only one in 3 older adults, on average protected.” That, he admitted, is also due in part to higher rates of vaccine hesitation among older people in some countries. Inconsistent vaccination coverage in the Americas ‘worrisome’ Similar inconsistencies in vaccination coverage prevail in the Americas – where average vaccination rates are also 60% or more. And that remains a “worrisome sign”, said Etienne. That is particularly true as the Americas region overall is still seeing rising rates of the Omicron variant – even while Europe seems to have turned the corner. While 14 countries and territories have immunized 70% of their populations, the same number of countries have yet to protect 40% of their people. More than 25% of people across the region have yet to receive a single dose of protection – rising to 54% in low- and middle-income countries, PAHO officials said. As in other parts of the world, countries that have experienced civil conflict, unrest and natural disasters lag even further behind. Haiti, notably, has less than 1% of its population fully vaccinated against COVID-19. The country began its vaccine drive late last year, having only received donations from donors such as the WHO-co sponsored COVAX initiative in July. Jamaica also is behind in its vaccinations – with only 21% of people fully vaccinated. Meanwhile, COVID-related deaths have increased for the fourth consecutive week in all subregions of north and south America and the Caribbean, with an increase of 33% last week over the week previous. That, officials added, further underscores the impacts of uneven vaccination rates – which continue to leave unvaccinated older and more vulnerable groups more prone to serious disease. Image Credits: Daily Caller/Twitter , Radio Metropolitana Cuba/Twitter . In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. 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More Clarity on Negotiators to Take Forward WHO Pandemic ‘Instrument’ Talks 04/02/2022 Kerry Cullinan WHA’s Special Session resolved on 1 December 2021 to negotiate a new global pandemic instrument. Representatives from Brazil, Egypt, Japan, Netherlands, South Africa, and Thailand are to make up the World Health Organization (WHO) Intergovernmental Negotiating Body (INB) on a future pandemic instrument, according to Knowledge Ecology International. The countries each represent a different region of the WHO, namely Africa (South Africa), the Americas, known as the Pan-American Health Organisation (Brazil), the South-East Asian Region (Thailand), Europe (Netherlands), the Eastern Mediterranean (Egypt) and the Western Pacific (Japan). South Africa confirmed that it had been chosen to represent Africa at the INB at last week’s WHO executive board meeting, while the European Union announced that it would be represented by an official from the Netherlands. Last year’s World Health Assembly (WHA) Special Session resolved to start intergovernmental negotiations “to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response”. According to the WHA resolution, the first INB meeting shall be held no later than 1 March to “elect two co-chairs, reflecting a balance of developed and developing countries, and four vice-chairs, one from each of the six WHO regions” as well as “define and agree on its working methods and timelines”. The resolution also directs the INB to “first identify the substantive elements of the instrument and to then begin the development of a working draft to be presented, on the basis of progress achieved, for the consideration of the INB at its second meeting, to be held no later than 1 August 2022”. The INB has until the 77th WHA next year to present a draft of the instrument, but needs to present a progress report to this year’s WHA. Thirty African Countries Now Back Africa Medicines Agency Treaty But Continent’s Economic Powers Still Hold Out 03/02/2022 Paul Adepoju Ambassador Samate Cessouma Minata, AU Commissioner for Health, Humanitarian Affairs and Social Development (HHS) Some 21 countries have now ratified the African Medicines Agency treaty – well beyond the 15 ratifications reached in November 2021, which allowed the AMA treaty instrument to formally take effect. Egypt, Africa’s third most populous country, is the most recent state to have both ratified and deposited the treaty – marking a significant milestone in the efforts to get the continent’s bigger players on board. Altogether, 19 African countries have both ratified and deposited the AMA treaty instrument to the AU secretariat, said Cessouma Minata Samate, African Union Commissioner for Health, Humanitarian Affairs and Social Development, at a press briefing on Thursday. She was speaking at a briefing on the margins of the 35th African Union Summit, which takes place this weekend. Two more countries, Morocco and Saharawi, have also ratified the treaty – but are yet to deposit it – rounding out the 21. Another nine countries have signed the treaty, but are yet to ratify it – including Equatorial Guinea and Comoros, which signed over just the past week, said Samate. All in all, that makes for a total of 30 countries that are formally on board with the treaty through signature, ratification, or both – while 25 still remain uncommitted. The new agency is supposed to provide a streamlined regulatory authority that would improve quality medicines access, and combat substandard imports, backers say. “The AMA will also guide the regulation of medicines, and facilitate access to quality medicines on the continent,” underlined Samate. Africa’s biggest economies still hold out Despite that promise, the 25 countries that have not yet signed the treaty include most of Africa’s population and economic powerhouses — such as Nigeria, South Africa, Kenya and Ethiopia. Responding to queries regarding the fence-sitters, Samate deferred, attributing the delays to variations in respective countries’ signing and ratification procedures. “I do not want to answer why Ethiopia did not sign; I am not part of the government. But each country has its procedure. There are several procedures involved. There is a whole process for it to arrive at the Parliament which will ratify it, and it depends on each country,” she said. “Each country has its rules for signing and ratifying treaties,” she said. She however added that since the treaty is new, sufficient time has to be given to Member States to sign and ratify it. Ultimately, however, all member states recognise it is in the best interest of citizens on the continent. “I am sure that all the countries are committed.” AMA will improve medicines regulation and access on the continent State of play as of 2 February in the alignment of 30 AU member states around the AMA treaty. Another 25 states have yet to sign or ratify. Samate noted that the AMA will be important in coordinating between the continent’s sub regional blocs, which have different economic alliances, also affecting trade and thereby medicines regulations. “The agency will coordinate the actors at the level of our subregional economic communities, and will work with AU Member States to enable us to have efficient health systems to treat our various populations.” “It’s important for us to have an agency for ourselves – to serve as a regulator for medicines issues on the continent,” she said. Others have emphasized that the AMA could help speed access to medicines – by conducting reviews and issuing recommendations on new treatments, which could take counties much longer to tackle individually. And it could help bring down some medicines prices by facilitating regulatory harmonization – which permits more bulk imports. In addition, it is hoped that the agency can play a role in fighting substandard and fake medicines. Currently WHO’s African Region suffers from the highest rates of reports of fake and substandard medicines in the world, according to both the WHO and AU officials. Timeline for setting up the new agency The next step in transforming the AMA from a treaty to an actual institution is to decide on a host country for the agency’s headquarters, Samate told journalists. This is not expected to be completed at the AU Summit – insofar as the criteria and process are yet to be announced. But she affirmed that the process would get underway “very shortly.” “There will be a process to allow the member states to decide, very shortly, which African country will host the AMA,” she told journalists. Sources, however, told Health Policy Watch that the process of assessing countries vying to host the AMA may not really begin until April. However an initial meeting of the AMA Conference of State Parties (CoSP) is scheduled for May – where an assessment report will be presented for discussion on recommendations for AMA host country. Following that, the terms of reference for the AMA Director-General will then be considered by the CoSP – to pave the way for recruitment of an agency head. Lastly, the site for the proposed AMA headquarters is expected to be adopted by the AU Assembly to be held in July 2022. Meeting ambitious goals The AMA treaty document was first approved by the African Union in 2019. At a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda in December 2021, panellists described the AMA as critical to Africa achieving the set goal of producing 60% of vaccines on its own soil by 2040. Ahead of the African Union Summit held over the past weekend, the African Medicines Agency Treaty Alliance (AMATA), an alliance that represents patients, academia, civil society, and industry set up to advocate for the ratification and implementation of the AMA, applauded the momentum reached so far. As the 35th #AUSummit takes place, we as #AMATA members call on the @_AfricanUnion to now prepare for the practical implementation of the Treaty establishing the #AfricanMedicinesAgency, bringing Africa🌍a step closer to having a continent-wide regulatory agency! pic.twitter.com/x8K1aORGZN — IAPO (@IAPOvoice) February 4, 2022 They called for a set of key steps to be taken in order to operationalise the Agency, including setting up a secretariat and choosing its location, adequate human resource capacity to operationalise its mandate and a sustainable funding model to ensure short- and long-term stability. AMATA also stressed the importance of recognizing patients as key partners in the development of the Agency – as part of a framework of engagement with non-state actors, including academia, research bodies, private sector and other civil society groups. They also appealed to all other African countries to ratify the AMA to “strengthen the continent’s capacity and preparedness to deal with future pandemics”, foster a spirit of cooperation to enable the development of medicines and vaccines, and safeguard the health of the continent and to protect citizens of Africa from fake m. Image Credits: African Union . Cancer Services and Routine Immunizations Backlogged – as Some Countries Anticipate Pandemic ‘Ceasefire’ – WHO 03/02/2022 Elaine Ruth Fletcher & Raisa Santos Hans Kluge, WHO European Regional Director Cancer services remain backlogged in many parts of the world due to the effects of the two-year-long COVID pandemic – even as Europe hopes a pandemic “ceasefire that could bring us enduring peace” , said WHO’s European Regional Director Hans Kluge Thursday on the eve of World Cancer Day. Meanwhile, in Latin America, routine childhood immunizations are down by around 10% as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases, said Carissa Etienne, Regional Director of the Pan American Health Organization in a briefing Wednesday evening. Both WHO regions, which include some of the world’s highest income countries, as well as middle income nations, alongside low-income states, continue to face striking regional imbalances in vaccine distribution, top officials in the two regions also stress – with some countries reaching 70% COVID vaccine countries or more – while others only have reached about 30% of eligible adults with jabs, both Etienne and Kluge stressed in separate press briefings. And that still leaves some countries disproportionately vulnerable to the ongoing effects of the Omicron variant – as well as to risks of new emerging variants. Cancer – knock-on effects will last for years Cancer services were disrupted up to 50% in the WHO Europe region. The two-year ongoing pandemic has had “catastrophic” effects on people with cancer, said Kluge, in his remarks – “going far beyond the disease itself.” One in four people in WHO’s European Region will receive a cancer diagnosis at some point in their lives – and cancer accounts for more than 20% of morbidity and mortality in the WHO region that extends from the Central Asian republics to the United Kingdom, he noted. In the European region, cancer diagnosis and treatment services saw disruptions of up to 50% in the early stages of the pandemic he noted. And while many EU countries have since rebounded, the picture remains uneven regionally and around the world. The latest WHO Global Pulse survey on disruptions in essential health service found that in the last quarter of 2021, countries worldwide were still experiencing disruptions in cancer screening and treatment services of between 5-50%, Kluge said. “The knock-on effects of this disruption will be felt for years,” Kluge added, noting that 44% of countries worldwide were reporting backlogs in cancer screening in the second half of 2021. Any post-Omicron ‘respite’ must be used to restore other essential health services Problems are compounded, he added, by the fact that the “health workforce is overstretched and exhausted – after being repurposed to address the direct impact of the virus. “Any respite the widespread immunity provides, thanks to vaccination and in the wake of the less severe Omicron, together with the coming spring and summer season, must be used immediately to enable health workers to return to other important health care functions, in order to bring backlogs for chronic care services down. “As we go forward, maintenance of essential health services, including services along the journey of cancer care, from prevention, early detection, diagnosis, treatment and quality of care will be a component of emergency planning and response,” he said. Americas also struggling to overcome disruptions in routine childhood vaccinations A child receives a routine vaccination in Cuba, which is a world leader in childhood immunization. Meanwhile, speaking from Washington DC, PAHO’s Etienne sounded a similar theme. But her message was focused around pandemic-related setbacks in childhood vaccinations across the WHO’s Americas’ region – which includes the affluent USA and Canada, alongside high, middle and low income countries of Latin America and the Caribbean. Routine childhood vaccinations for a third dose of diphtheria, tetanus, pertussis (DTP) vaccine has declined by 10% in the region, as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases because of lower immunization coverage, she said: “Despite the tremendous achievements of immunization programs in past decades, that progress has stalled in some countries, and has even reversed in this region.” Carissa Etienne, Director of the Pan American Health Organization/WHO Region of the Americas While the goal was to fully cover at least 95% of eligible children in 2020 with the DTP vaccine, 26 countries and territories of the Americas did not reach that goal. And some 14 countries in the region had particularly low coverage with the third dose – of 10% or less. As in Europe, she attributed the setbacks to the reassignment of healthcare professionals from primary care centers to hospitals and intensive care units – alongside public hesitations about getting vaccinated during the pandemic. PAHO is currently working with Ministries of Health across the Americas to revitalize family immunization programs as one of their “highest priorities”. “We are at a juncture where it is urgent to look at routine immunization programs,” said Etienne. As countries reopen – uneven vaccination coverage exacerbates future variant risks Both Europe and the Americas also are facing major inconsistencies in vaccine coverage rates within countries of the region, the officials also noted. And that poses additional risks as countries relax restrictions, Kluge stressed. “We in the European region have a unique situation,” Kluge said. “Once the Omicron wave has subsided, there will be a large capital of [SARS-CoV2] immunity, due to the infection in general, and quite high vaccination rates generally.” That offers opportunities to restore normalcy and “respond to new variants that will inevitably emerge without reinstalling the kind of disruptive measures that we needed before,” he said. Can the pandemic ceasefire bring enduring peace? “This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace,” he said. But he insisted that his message does not contradict those coming from Geneva, either, where WHO’s Director General Tedros Adhanom Ghebreyesus urged caution in reopening economies at a briefing earlier in the week. “The pandemic is not over, as Dr Tedros is rightly saying.” In particular, vaccination rates need to be pushed higher in undercovered parts of the Europe – as well as worldwide – to expand protection against the emergence of still newer, and potentially more dangerous variants, Kluge stressed. “It is because we see the opportunity that the top priority is to bring all countries to a level of protection which allows them to grasp this opportunity and look ahead towards more stable days “And that means that we need a drastic and uncompromising increase in vaccine-sharing.” For instance, while 66% of people across WHO’s vast European region have received a second vaccine dose, the numbers go as high as 70% in high income countries – where 40% of the population also has boosters, said Oleg Benes, another WHO European region official. But in the region’s lower middle income countries, rates remain much lower. “Booster courses are just starting to roll out.” Vaccine rates are as low as 30% in some countries, with only one in 3 older adults, on average protected.” That, he admitted, is also due in part to higher rates of vaccine hesitation among older people in some countries. Inconsistent vaccination coverage in the Americas ‘worrisome’ Similar inconsistencies in vaccination coverage prevail in the Americas – where average vaccination rates are also 60% or more. And that remains a “worrisome sign”, said Etienne. That is particularly true as the Americas region overall is still seeing rising rates of the Omicron variant – even while Europe seems to have turned the corner. While 14 countries and territories have immunized 70% of their populations, the same number of countries have yet to protect 40% of their people. More than 25% of people across the region have yet to receive a single dose of protection – rising to 54% in low- and middle-income countries, PAHO officials said. As in other parts of the world, countries that have experienced civil conflict, unrest and natural disasters lag even further behind. Haiti, notably, has less than 1% of its population fully vaccinated against COVID-19. The country began its vaccine drive late last year, having only received donations from donors such as the WHO-co sponsored COVAX initiative in July. Jamaica also is behind in its vaccinations – with only 21% of people fully vaccinated. Meanwhile, COVID-related deaths have increased for the fourth consecutive week in all subregions of north and south America and the Caribbean, with an increase of 33% last week over the week previous. That, officials added, further underscores the impacts of uneven vaccination rates – which continue to leave unvaccinated older and more vulnerable groups more prone to serious disease. Image Credits: Daily Caller/Twitter , Radio Metropolitana Cuba/Twitter . In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. 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Thirty African Countries Now Back Africa Medicines Agency Treaty But Continent’s Economic Powers Still Hold Out 03/02/2022 Paul Adepoju Ambassador Samate Cessouma Minata, AU Commissioner for Health, Humanitarian Affairs and Social Development (HHS) Some 21 countries have now ratified the African Medicines Agency treaty – well beyond the 15 ratifications reached in November 2021, which allowed the AMA treaty instrument to formally take effect. Egypt, Africa’s third most populous country, is the most recent state to have both ratified and deposited the treaty – marking a significant milestone in the efforts to get the continent’s bigger players on board. Altogether, 19 African countries have both ratified and deposited the AMA treaty instrument to the AU secretariat, said Cessouma Minata Samate, African Union Commissioner for Health, Humanitarian Affairs and Social Development, at a press briefing on Thursday. She was speaking at a briefing on the margins of the 35th African Union Summit, which takes place this weekend. Two more countries, Morocco and Saharawi, have also ratified the treaty – but are yet to deposit it – rounding out the 21. Another nine countries have signed the treaty, but are yet to ratify it – including Equatorial Guinea and Comoros, which signed over just the past week, said Samate. All in all, that makes for a total of 30 countries that are formally on board with the treaty through signature, ratification, or both – while 25 still remain uncommitted. The new agency is supposed to provide a streamlined regulatory authority that would improve quality medicines access, and combat substandard imports, backers say. “The AMA will also guide the regulation of medicines, and facilitate access to quality medicines on the continent,” underlined Samate. Africa’s biggest economies still hold out Despite that promise, the 25 countries that have not yet signed the treaty include most of Africa’s population and economic powerhouses — such as Nigeria, South Africa, Kenya and Ethiopia. Responding to queries regarding the fence-sitters, Samate deferred, attributing the delays to variations in respective countries’ signing and ratification procedures. “I do not want to answer why Ethiopia did not sign; I am not part of the government. But each country has its procedure. There are several procedures involved. There is a whole process for it to arrive at the Parliament which will ratify it, and it depends on each country,” she said. “Each country has its rules for signing and ratifying treaties,” she said. She however added that since the treaty is new, sufficient time has to be given to Member States to sign and ratify it. Ultimately, however, all member states recognise it is in the best interest of citizens on the continent. “I am sure that all the countries are committed.” AMA will improve medicines regulation and access on the continent State of play as of 2 February in the alignment of 30 AU member states around the AMA treaty. Another 25 states have yet to sign or ratify. Samate noted that the AMA will be important in coordinating between the continent’s sub regional blocs, which have different economic alliances, also affecting trade and thereby medicines regulations. “The agency will coordinate the actors at the level of our subregional economic communities, and will work with AU Member States to enable us to have efficient health systems to treat our various populations.” “It’s important for us to have an agency for ourselves – to serve as a regulator for medicines issues on the continent,” she said. Others have emphasized that the AMA could help speed access to medicines – by conducting reviews and issuing recommendations on new treatments, which could take counties much longer to tackle individually. And it could help bring down some medicines prices by facilitating regulatory harmonization – which permits more bulk imports. In addition, it is hoped that the agency can play a role in fighting substandard and fake medicines. Currently WHO’s African Region suffers from the highest rates of reports of fake and substandard medicines in the world, according to both the WHO and AU officials. Timeline for setting up the new agency The next step in transforming the AMA from a treaty to an actual institution is to decide on a host country for the agency’s headquarters, Samate told journalists. This is not expected to be completed at the AU Summit – insofar as the criteria and process are yet to be announced. But she affirmed that the process would get underway “very shortly.” “There will be a process to allow the member states to decide, very shortly, which African country will host the AMA,” she told journalists. Sources, however, told Health Policy Watch that the process of assessing countries vying to host the AMA may not really begin until April. However an initial meeting of the AMA Conference of State Parties (CoSP) is scheduled for May – where an assessment report will be presented for discussion on recommendations for AMA host country. Following that, the terms of reference for the AMA Director-General will then be considered by the CoSP – to pave the way for recruitment of an agency head. Lastly, the site for the proposed AMA headquarters is expected to be adopted by the AU Assembly to be held in July 2022. Meeting ambitious goals The AMA treaty document was first approved by the African Union in 2019. At a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda in December 2021, panellists described the AMA as critical to Africa achieving the set goal of producing 60% of vaccines on its own soil by 2040. Ahead of the African Union Summit held over the past weekend, the African Medicines Agency Treaty Alliance (AMATA), an alliance that represents patients, academia, civil society, and industry set up to advocate for the ratification and implementation of the AMA, applauded the momentum reached so far. As the 35th #AUSummit takes place, we as #AMATA members call on the @_AfricanUnion to now prepare for the practical implementation of the Treaty establishing the #AfricanMedicinesAgency, bringing Africa🌍a step closer to having a continent-wide regulatory agency! pic.twitter.com/x8K1aORGZN — IAPO (@IAPOvoice) February 4, 2022 They called for a set of key steps to be taken in order to operationalise the Agency, including setting up a secretariat and choosing its location, adequate human resource capacity to operationalise its mandate and a sustainable funding model to ensure short- and long-term stability. AMATA also stressed the importance of recognizing patients as key partners in the development of the Agency – as part of a framework of engagement with non-state actors, including academia, research bodies, private sector and other civil society groups. They also appealed to all other African countries to ratify the AMA to “strengthen the continent’s capacity and preparedness to deal with future pandemics”, foster a spirit of cooperation to enable the development of medicines and vaccines, and safeguard the health of the continent and to protect citizens of Africa from fake m. Image Credits: African Union . Cancer Services and Routine Immunizations Backlogged – as Some Countries Anticipate Pandemic ‘Ceasefire’ – WHO 03/02/2022 Elaine Ruth Fletcher & Raisa Santos Hans Kluge, WHO European Regional Director Cancer services remain backlogged in many parts of the world due to the effects of the two-year-long COVID pandemic – even as Europe hopes a pandemic “ceasefire that could bring us enduring peace” , said WHO’s European Regional Director Hans Kluge Thursday on the eve of World Cancer Day. Meanwhile, in Latin America, routine childhood immunizations are down by around 10% as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases, said Carissa Etienne, Regional Director of the Pan American Health Organization in a briefing Wednesday evening. Both WHO regions, which include some of the world’s highest income countries, as well as middle income nations, alongside low-income states, continue to face striking regional imbalances in vaccine distribution, top officials in the two regions also stress – with some countries reaching 70% COVID vaccine countries or more – while others only have reached about 30% of eligible adults with jabs, both Etienne and Kluge stressed in separate press briefings. And that still leaves some countries disproportionately vulnerable to the ongoing effects of the Omicron variant – as well as to risks of new emerging variants. Cancer – knock-on effects will last for years Cancer services were disrupted up to 50% in the WHO Europe region. The two-year ongoing pandemic has had “catastrophic” effects on people with cancer, said Kluge, in his remarks – “going far beyond the disease itself.” One in four people in WHO’s European Region will receive a cancer diagnosis at some point in their lives – and cancer accounts for more than 20% of morbidity and mortality in the WHO region that extends from the Central Asian republics to the United Kingdom, he noted. In the European region, cancer diagnosis and treatment services saw disruptions of up to 50% in the early stages of the pandemic he noted. And while many EU countries have since rebounded, the picture remains uneven regionally and around the world. The latest WHO Global Pulse survey on disruptions in essential health service found that in the last quarter of 2021, countries worldwide were still experiencing disruptions in cancer screening and treatment services of between 5-50%, Kluge said. “The knock-on effects of this disruption will be felt for years,” Kluge added, noting that 44% of countries worldwide were reporting backlogs in cancer screening in the second half of 2021. Any post-Omicron ‘respite’ must be used to restore other essential health services Problems are compounded, he added, by the fact that the “health workforce is overstretched and exhausted – after being repurposed to address the direct impact of the virus. “Any respite the widespread immunity provides, thanks to vaccination and in the wake of the less severe Omicron, together with the coming spring and summer season, must be used immediately to enable health workers to return to other important health care functions, in order to bring backlogs for chronic care services down. “As we go forward, maintenance of essential health services, including services along the journey of cancer care, from prevention, early detection, diagnosis, treatment and quality of care will be a component of emergency planning and response,” he said. Americas also struggling to overcome disruptions in routine childhood vaccinations A child receives a routine vaccination in Cuba, which is a world leader in childhood immunization. Meanwhile, speaking from Washington DC, PAHO’s Etienne sounded a similar theme. But her message was focused around pandemic-related setbacks in childhood vaccinations across the WHO’s Americas’ region – which includes the affluent USA and Canada, alongside high, middle and low income countries of Latin America and the Caribbean. Routine childhood vaccinations for a third dose of diphtheria, tetanus, pertussis (DTP) vaccine has declined by 10% in the region, as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases because of lower immunization coverage, she said: “Despite the tremendous achievements of immunization programs in past decades, that progress has stalled in some countries, and has even reversed in this region.” Carissa Etienne, Director of the Pan American Health Organization/WHO Region of the Americas While the goal was to fully cover at least 95% of eligible children in 2020 with the DTP vaccine, 26 countries and territories of the Americas did not reach that goal. And some 14 countries in the region had particularly low coverage with the third dose – of 10% or less. As in Europe, she attributed the setbacks to the reassignment of healthcare professionals from primary care centers to hospitals and intensive care units – alongside public hesitations about getting vaccinated during the pandemic. PAHO is currently working with Ministries of Health across the Americas to revitalize family immunization programs as one of their “highest priorities”. “We are at a juncture where it is urgent to look at routine immunization programs,” said Etienne. As countries reopen – uneven vaccination coverage exacerbates future variant risks Both Europe and the Americas also are facing major inconsistencies in vaccine coverage rates within countries of the region, the officials also noted. And that poses additional risks as countries relax restrictions, Kluge stressed. “We in the European region have a unique situation,” Kluge said. “Once the Omicron wave has subsided, there will be a large capital of [SARS-CoV2] immunity, due to the infection in general, and quite high vaccination rates generally.” That offers opportunities to restore normalcy and “respond to new variants that will inevitably emerge without reinstalling the kind of disruptive measures that we needed before,” he said. Can the pandemic ceasefire bring enduring peace? “This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace,” he said. But he insisted that his message does not contradict those coming from Geneva, either, where WHO’s Director General Tedros Adhanom Ghebreyesus urged caution in reopening economies at a briefing earlier in the week. “The pandemic is not over, as Dr Tedros is rightly saying.” In particular, vaccination rates need to be pushed higher in undercovered parts of the Europe – as well as worldwide – to expand protection against the emergence of still newer, and potentially more dangerous variants, Kluge stressed. “It is because we see the opportunity that the top priority is to bring all countries to a level of protection which allows them to grasp this opportunity and look ahead towards more stable days “And that means that we need a drastic and uncompromising increase in vaccine-sharing.” For instance, while 66% of people across WHO’s vast European region have received a second vaccine dose, the numbers go as high as 70% in high income countries – where 40% of the population also has boosters, said Oleg Benes, another WHO European region official. But in the region’s lower middle income countries, rates remain much lower. “Booster courses are just starting to roll out.” Vaccine rates are as low as 30% in some countries, with only one in 3 older adults, on average protected.” That, he admitted, is also due in part to higher rates of vaccine hesitation among older people in some countries. Inconsistent vaccination coverage in the Americas ‘worrisome’ Similar inconsistencies in vaccination coverage prevail in the Americas – where average vaccination rates are also 60% or more. And that remains a “worrisome sign”, said Etienne. That is particularly true as the Americas region overall is still seeing rising rates of the Omicron variant – even while Europe seems to have turned the corner. While 14 countries and territories have immunized 70% of their populations, the same number of countries have yet to protect 40% of their people. More than 25% of people across the region have yet to receive a single dose of protection – rising to 54% in low- and middle-income countries, PAHO officials said. As in other parts of the world, countries that have experienced civil conflict, unrest and natural disasters lag even further behind. Haiti, notably, has less than 1% of its population fully vaccinated against COVID-19. The country began its vaccine drive late last year, having only received donations from donors such as the WHO-co sponsored COVAX initiative in July. Jamaica also is behind in its vaccinations – with only 21% of people fully vaccinated. Meanwhile, COVID-related deaths have increased for the fourth consecutive week in all subregions of north and south America and the Caribbean, with an increase of 33% last week over the week previous. That, officials added, further underscores the impacts of uneven vaccination rates – which continue to leave unvaccinated older and more vulnerable groups more prone to serious disease. Image Credits: Daily Caller/Twitter , Radio Metropolitana Cuba/Twitter . In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. 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.
Cancer Services and Routine Immunizations Backlogged – as Some Countries Anticipate Pandemic ‘Ceasefire’ – WHO 03/02/2022 Elaine Ruth Fletcher & Raisa Santos Hans Kluge, WHO European Regional Director Cancer services remain backlogged in many parts of the world due to the effects of the two-year-long COVID pandemic – even as Europe hopes a pandemic “ceasefire that could bring us enduring peace” , said WHO’s European Regional Director Hans Kluge Thursday on the eve of World Cancer Day. Meanwhile, in Latin America, routine childhood immunizations are down by around 10% as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases, said Carissa Etienne, Regional Director of the Pan American Health Organization in a briefing Wednesday evening. Both WHO regions, which include some of the world’s highest income countries, as well as middle income nations, alongside low-income states, continue to face striking regional imbalances in vaccine distribution, top officials in the two regions also stress – with some countries reaching 70% COVID vaccine countries or more – while others only have reached about 30% of eligible adults with jabs, both Etienne and Kluge stressed in separate press briefings. And that still leaves some countries disproportionately vulnerable to the ongoing effects of the Omicron variant – as well as to risks of new emerging variants. Cancer – knock-on effects will last for years Cancer services were disrupted up to 50% in the WHO Europe region. The two-year ongoing pandemic has had “catastrophic” effects on people with cancer, said Kluge, in his remarks – “going far beyond the disease itself.” One in four people in WHO’s European Region will receive a cancer diagnosis at some point in their lives – and cancer accounts for more than 20% of morbidity and mortality in the WHO region that extends from the Central Asian republics to the United Kingdom, he noted. In the European region, cancer diagnosis and treatment services saw disruptions of up to 50% in the early stages of the pandemic he noted. And while many EU countries have since rebounded, the picture remains uneven regionally and around the world. The latest WHO Global Pulse survey on disruptions in essential health service found that in the last quarter of 2021, countries worldwide were still experiencing disruptions in cancer screening and treatment services of between 5-50%, Kluge said. “The knock-on effects of this disruption will be felt for years,” Kluge added, noting that 44% of countries worldwide were reporting backlogs in cancer screening in the second half of 2021. Any post-Omicron ‘respite’ must be used to restore other essential health services Problems are compounded, he added, by the fact that the “health workforce is overstretched and exhausted – after being repurposed to address the direct impact of the virus. “Any respite the widespread immunity provides, thanks to vaccination and in the wake of the less severe Omicron, together with the coming spring and summer season, must be used immediately to enable health workers to return to other important health care functions, in order to bring backlogs for chronic care services down. “As we go forward, maintenance of essential health services, including services along the journey of cancer care, from prevention, early detection, diagnosis, treatment and quality of care will be a component of emergency planning and response,” he said. Americas also struggling to overcome disruptions in routine childhood vaccinations A child receives a routine vaccination in Cuba, which is a world leader in childhood immunization. Meanwhile, speaking from Washington DC, PAHO’s Etienne sounded a similar theme. But her message was focused around pandemic-related setbacks in childhood vaccinations across the WHO’s Americas’ region – which includes the affluent USA and Canada, alongside high, middle and low income countries of Latin America and the Caribbean. Routine childhood vaccinations for a third dose of diphtheria, tetanus, pertussis (DTP) vaccine has declined by 10% in the region, as a result of setbacks from the COVID-19 pandemic, leaving the region at very “high-risk” for new and re-emergent vaccine-preventable diseases because of lower immunization coverage, she said: “Despite the tremendous achievements of immunization programs in past decades, that progress has stalled in some countries, and has even reversed in this region.” Carissa Etienne, Director of the Pan American Health Organization/WHO Region of the Americas While the goal was to fully cover at least 95% of eligible children in 2020 with the DTP vaccine, 26 countries and territories of the Americas did not reach that goal. And some 14 countries in the region had particularly low coverage with the third dose – of 10% or less. As in Europe, she attributed the setbacks to the reassignment of healthcare professionals from primary care centers to hospitals and intensive care units – alongside public hesitations about getting vaccinated during the pandemic. PAHO is currently working with Ministries of Health across the Americas to revitalize family immunization programs as one of their “highest priorities”. “We are at a juncture where it is urgent to look at routine immunization programs,” said Etienne. As countries reopen – uneven vaccination coverage exacerbates future variant risks Both Europe and the Americas also are facing major inconsistencies in vaccine coverage rates within countries of the region, the officials also noted. And that poses additional risks as countries relax restrictions, Kluge stressed. “We in the European region have a unique situation,” Kluge said. “Once the Omicron wave has subsided, there will be a large capital of [SARS-CoV2] immunity, due to the infection in general, and quite high vaccination rates generally.” That offers opportunities to restore normalcy and “respond to new variants that will inevitably emerge without reinstalling the kind of disruptive measures that we needed before,” he said. Can the pandemic ceasefire bring enduring peace? “This period of higher protection should be seen as a ‘ceasefire’ that could bring us enduring peace,” he said. But he insisted that his message does not contradict those coming from Geneva, either, where WHO’s Director General Tedros Adhanom Ghebreyesus urged caution in reopening economies at a briefing earlier in the week. “The pandemic is not over, as Dr Tedros is rightly saying.” In particular, vaccination rates need to be pushed higher in undercovered parts of the Europe – as well as worldwide – to expand protection against the emergence of still newer, and potentially more dangerous variants, Kluge stressed. “It is because we see the opportunity that the top priority is to bring all countries to a level of protection which allows them to grasp this opportunity and look ahead towards more stable days “And that means that we need a drastic and uncompromising increase in vaccine-sharing.” For instance, while 66% of people across WHO’s vast European region have received a second vaccine dose, the numbers go as high as 70% in high income countries – where 40% of the population also has boosters, said Oleg Benes, another WHO European region official. But in the region’s lower middle income countries, rates remain much lower. “Booster courses are just starting to roll out.” Vaccine rates are as low as 30% in some countries, with only one in 3 older adults, on average protected.” That, he admitted, is also due in part to higher rates of vaccine hesitation among older people in some countries. Inconsistent vaccination coverage in the Americas ‘worrisome’ Similar inconsistencies in vaccination coverage prevail in the Americas – where average vaccination rates are also 60% or more. And that remains a “worrisome sign”, said Etienne. That is particularly true as the Americas region overall is still seeing rising rates of the Omicron variant – even while Europe seems to have turned the corner. While 14 countries and territories have immunized 70% of their populations, the same number of countries have yet to protect 40% of their people. More than 25% of people across the region have yet to receive a single dose of protection – rising to 54% in low- and middle-income countries, PAHO officials said. As in other parts of the world, countries that have experienced civil conflict, unrest and natural disasters lag even further behind. Haiti, notably, has less than 1% of its population fully vaccinated against COVID-19. The country began its vaccine drive late last year, having only received donations from donors such as the WHO-co sponsored COVAX initiative in July. Jamaica also is behind in its vaccinations – with only 21% of people fully vaccinated. Meanwhile, COVID-related deaths have increased for the fourth consecutive week in all subregions of north and south America and the Caribbean, with an increase of 33% last week over the week previous. That, officials added, further underscores the impacts of uneven vaccination rates – which continue to leave unvaccinated older and more vulnerable groups more prone to serious disease. Image Credits: Daily Caller/Twitter , Radio Metropolitana Cuba/Twitter . In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. 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.
In Unusual Move, US FDA Invites Pfizer to Request COVID-19 Vaccine Approval for Infants and Toddlers 02/02/2022 Zachary Brennan Child COVID vaccinations – now the FDA has invited Pfizer to submit for approval of vaccines for under-5s. What does the FDA know that we don’t? Hopefully a lot. Without offering much detail, the FDA yesterday afternoon asked Pfizer to send over a rolling submission to amend its Covid-19 vaccine Emergency Use Authorization to include children 6 months to under 5 years of age. The tricky part in making such a request is that last month, Pfizer announced that its vaccine (a 3 µg dose for the youngest population) had performed better in the 6- to 24-month-old population, than in children ages 2-4 – that is as compared to the results of the vaccine among 16- to 25-year-olds, in which high efficacy was demonstrated. But the company wants to test a third jab for all of the under-5s to see if it will even out the results somehow for older tots. And it doesn’t seem to be changing its tune, even with this latest FDA request. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose,” Pfizer CEO Albert Bourla said in a statement. No safety concerns were identified in that prior analysis of the 3 µg dose data among children 6 months to under 5 years of age, Pfizer said. While the FDA often requests that companies provide additional safety or efficacy data (usually before a new drug or vaccine is approved or authorized), the agency rarely requests a specific submission, but acting FDA commissioner Janet Woodcock said this is a priority right now for the agency. Having a safe and effective vaccine available for children in this age group is a priority for the agency, and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. https://t.co/hXGSImQCJu — Dr. Janet Woodcock (@DrWoodcockFDA) February 1, 2022 But others are not so sure: “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s vaccine office, told STAT News. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.” See ENDPOINTS News: FDA takes a rare step and asks Pfizer to submit a COVID-19 vaccine EUA for the youngest children. Image Credits: Quinn Dombrowski. HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. 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
HIV Vaccine: Phase 1 Clinical Trial Tests mRNA Technology Against HIV 02/02/2022 Maayan Hoffman Moderna and the nonprofit science research organization IAVI have administered the first doses in a Phase I clinical trial of an experimental HIV vaccine, delivered by messenger RNA (mRNA) – the technology that revolutionized vaccines against COVID-19. The trial kicked off last week at George Washington University School of Medicine and Health Sciences in Washington, D.C. It is partially funded by the Bill & Melinda Gates Foundation. The Phase I trial, IAVI G002, is testing the hypothesis that sequential administration of priming and boosting HIV immunogens delivered by messenger RNA (mRNA) can induce specific classes of B-cell responses and guide their maturation to generate broadly neutralizing antibodies (bnAb) that would protect against disease, a joint statement by Moderna and IAVI explained. The immunogens being tested were developed by scientific teams at IAVI and the Scripps Research Institute, and will be delivered via Moderna’s mRNA technology. “The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine,” said Mark Feinberg, CEO of IAVI – whose board includes prominent names from industry, research, The Global Fund, and the Africa Centers for Disease Control. More than 36 million people have died of AIDS-related illnesses As of June 2021, 28.2 million people were using antiretroviral therapy for the treatment of HIV, according to UNAIDS, and 37.7 million people were living with the disease in 2020. Some 680,000 people died of AIDS-related illnesses in 2020. A total of 36.3 million people have died of AIDS since the virus exploded into a pandemic in the late 1980s. Photo: UNAIDS/Sydelle Willow Smith The mRNA vaccine strategy centers on stimulating the immune system to produce bnAbs against HIV, a process known as “germline-targeting.” Antibodies are produced by B cells, which start out in a “germline” state. BnAbs are believed to be capable of neutralizing different HIV strains by binding to hard-to-reach but consistent regions of the virus surface. If it works, the germline targeting strategy could offer protection against millions of different HIV strains circulating in various parts of the world. Last year, Dr William Schief, a professor at Scripps Research Institute and executive director of vaccine design at IAVI’s Neutralizing Antibody Center – who developed the HIV vaccine antigens being evaluated in mRNA formats in this study – announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the priming immunogen induced the desired B-cell response in 97% of recipients. Until now, no HIV vaccine candidate has been able to induce a protective bnAb response in humans. The release said that “given the speed with which mRNA vaccines can be produced,” using the platform could shave off years from typical vaccine development timelines – like it did for the development of an emergency coronavirus vaccine. ANNOUNCEMENT 📢: We are proud to announce that the first participant has been dosed in the Phase 1 study of mRNA-1644, our experimental #HIV #mRNA #vaccine candidate. Learn more about this exciting venture with @IAVI: https://t.co/apeIJpPbxz pic.twitter.com/1fON4j9hP7 — Moderna (@moderna_tx) January 27, 2022 “We believe advancing this HIV vaccine program in partnership with IAVI and Scripps Research is an important step in our mission to deliver on the potential for mRNA to improve human health,” said Moderna’s president Dr Stephen Hoge. Image Credits: Moderna, UNAIDS/Sydelle Willow Smith. Posts navigation Older postsNewer posts