Vaccines and Global Health: The Week in Review :: 16 October 2020

Vaccines and Global Health: The Week in Review is a weekly digest  summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

Solidarity Therapeutics Trial produces conclusive evidence on the effectiveness of repurposed drugs for COVID-19 in record time

Milestones :: Perspectives :: Research

 

Solidarity Therapeutics Trial produces conclusive evidence on the effectiveness of repurposed drugs for COVID-19 in record time
15 October 2020 News release
In just six months, the world’s largest randomized control trial on COVID-19 therapeutics has generated conclusive evidence on the effectiveness of repurposed drugs for the treatment of COVID-19.

Interim results from the Solidarity Therapeutics Trial, coordinated by the World Health Organization, indicate that remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.

The study, which spans more than 30 countries, looked at the effects of these treatments on overall mortality, initiation of ventilation, and duration of hospital stay in hospitalized patients. Other uses of the drugs, for example in treatment of patients in the community or for prevention, would have to be examined using different trials.

The progress achieved by the Solidarity Therapeutics Trial shows that large international trials are possible, even during a pandemic, and offer the promise of quickly and reliably answering critical public health questions concerning therapeutics.

The results of the trial are under review for publication in a medical journal and have been uploaded as preprint at medRxiv available at this link: https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1

The global platform of the Solidarity Trial is ready to rapidly evaluate promising new treatment options, with nearly 500 hospitals open as trial sites. Newer antiviral drugs, immunomodulators and anti-SARS COV-2 monoclonal antibodies are now being considered for evaluation.

 

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medRxiv
Posted October 15, 2020.
Repurposed antiviral drugs for COVID-19; interim WHO SOLIDARITY trial results
WHO Solidarity Trial Consortium, Hongchao Pan, Richard Peto, Quarraisha Abdool Karim, Marissa Alejandria, Ana Maria Henao Restrepo, Cesar Hernandez Garcia, Marie Paule Kieny, Reza Malekzadeh, Srinivas Murthy, Marie-Pierre Preziosi, Srinath Reddy, Mirta Roses, Vasee Sathiyamoorthy, John-Arne Rottingen, Soumya Swaminathan
doi: https://doi.org/10.1101/2020.10.15.20209817
This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.
Abstract
BACKGROUND WHO expert groups recommended mortality trials in hospitalized COVID-19 of four re-purposed antiviral drugs.
METHODS Study drugs were Remdesivir, Hydroxychloroquine, Lopinavir (fixed-dose combination with Ritonavir) and Interferon-β1a (mainly subcutaneous; initially with Lopinavir, later not). COVID-19 inpatients were randomized equally between whichever study drugs were locally available and open control (up to 5 options: 4 active and local standard-of-care). The intent-to-treat primary analyses are of in-hospital mortality in the 4 pairwise comparisons of each study drug vs its controls (concurrently allocated the same management without that drug, despite availability). Kaplan-Meier 28-day risks are unstratified; log-rank death rate ratios (RRs) are stratified for age and ventilation at entry.
RESULTS In 405 hospitals in 30 countries 11,266 adults were randomized, with 2750 allocated Remdesivir, 954 Hydroxychloroquine, 1411 Lopinavir, 651 Interferon plus Lopinavir, 1412 only Interferon, and 4088 no study drug. Compliance was 94-96% midway through treatment, with 2-6% crossover. 1253 deaths were reported (at median day 8, IQR 4-14). Kaplan-Meier 28-day mortality was 12% (39% if already ventilated at randomization, 10% otherwise). Death rate ratios (with 95% CIs and numbers dead/randomized, each drug vs its control) were: Remdesivir RR=0.95 (0.81-1.11, p=0.50; 301/2743 active vs 303/2708 control), Hydroxychloroquine RR=1.19 (0.89-1.59, p=0.23; 104/947 vs 84/906), Lopinavir RR=1.00 (0.79-1.25, p=0.97; 148/1399 vs 146/1372) and Interferon RR=1.16 (0.96-1.39, p=0.11; 243/2050 vs 216/2050). No study drug definitely reduced mortality (in unventilated patients or any other subgroup of entry characteristics), initiation of ventilation or hospitalisation duration.
CONCLUSIONS These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay. The mortality findings contain most of the randomized evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials.

Competing Interest Statement
The authors have declared no competing interest.
Clinical Trial
ISRCTN83971151, NCT04315948
Funding Statement
Funding was from WHO. No external funding was received.

COVID-19 Vaccines – World Bank Action

Milestones :: Perspectives :: Research

 

COVID-19 Vaccines – World Bank Action

World Bank Approves $12 Billion for COVID-19 Vaccines
WASHINGTON, October 13, 2020 – The World Bank’s Board of Executive Directors today approved an envelope of $12 billion for developing countries to finance the purchase and distribution of COVID-19 vaccines, tests, and treatments for their citizens.

The financing, which aims to support vaccination of up to a billion people, is part of an overall World Bank Group (WBG) package of up to $160 billion through June 2021 to help developing countries fight the COVID-19 pandemic. It adds new financing to the World Bank’s COVID-19 emergency response programs that are already reaching 111 countries. This financing package helps signal to the research and pharmaceutical industry that citizens in developing countries also need access to safe and effective COVID-19 vaccines.  It will also provide financing and technical support so that developing countries can prepare for deploying vaccines at scale, in coordination with international partners. In implementing the program, the World Bank will support multilateral efforts currently led by WHO and COVAX…

…Developing countries will have different ways to acquire and deliver approved vaccines. The approach draws on the WBG’s significant expertise in supporting large scale immunization programs for vaccine preventable diseases, as well as public health programs to tackle infectious diseases such as HIV, tuberculosis, malaria and neglected tropical diseases.

In addition to purchasing COVID-19 vaccines, the WBG financing will also support countries to access to COVID-19 tests and treatments, and expand immunization capacity to help health systems deploy the vaccines effectively.  This includes supply chain and logistics management for vaccine storage handling, trained vaccinators, and large-scale communication and outreach campaigns to reach communities and households…

 

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World Bank Factsheet October 15, 2020
WBG VACCINE ANNOUNCEMENT– KEY FACTS
An effective and safe COVID-19 vaccine is the most promising path forward for the world to reopen safely. The global economy will not recover fully until people feel they can live, socialize, work, and travel with confidence.

 

Financing:
:: The World Bank’s Board of Executive Directors has approved an envelope of $12 billion for developing countries to finance the purchase and distribution of COVID-19 vaccines, tests, and treatments for their citizens.
:: This financing will support broad and rapid access to vaccines.  It will support countries in getting initial vaccine doses to those who need them first in low- and middle-income countries (IDA and IBRD) that have limited access.
:: This builds on the COVID emergency response programs that we already have up and running in 111 countries, which are making rapid progress.
:: We are aiming to disburse the largest share of this support in the next 12 to 24 months. Financing will be available immediately and will be provided in accordance with countries’ existing eligibility for grants, credits, and loans.
:: This financing package helps signal to the research and pharmaceutical industry that citizens in developing countries need equal access to safe and effective COVID-19 vaccines.
:: Global access to safe and effective vaccines will save lives and livelihoods and accelerate the economic and social recovery the world needs.

How it works:
Developing countries will have flexibility to choose the best approach and to use the financing in ways that best help them, based on their specific context and needs:
:: To facilitate access, we will help countries procure vaccines through various approaches (i.e., country mechanisms, multilateral mechanisms currently led by WHO and GAVI through COVAX, Bank-facilitated procurement and implementation support).
:: To support deployment, the Bank is working with partners to assess the readiness of country health systems and identify gaps and areas for possible investment, as part of our ongoing support to countries’ COVID-19 response. This involves analysis of policy and regulatory capacities, information systems, and health infrastructure including cold chains, as well as consultations with communities and beneficiaries.

 

The Bank will help client countries develop appropriate criteria for making the selected vaccine available to all their citizens.
:: There is consensus to first target health workers, other essential workers, and priority groups such as the elderly, people with co-morbidities, and others at high risk from COVID-19.
:: The Bank will ensure that the allocation mechanisms within countries are fair and equitable.

Eligible low and middle-income countries (IBRD/IDA countries) can apply for financing as part of their coronavirus responses, including for the purchase and distribution of vaccines.
:: Interested governments will work with the World Bank to prepare a project document under the World Bank’s fast-track emergency response that details how the financing will be used.

 

IFC’s support on vaccines
Another important part of the World Bank Group’s response has come from IFC [International Finance Corporation], our private sector arm: the $4 billion Global Health Platform, through which we will support private companies in delivering health products and services – including vaccines – to developing countries. This includes:
:: Investments in vaccine manufacturers to foster expanded production of COVID-19 vaccines in low- and middle-income countries, with production reserved for emerging markets.
:: Ability to invest in production to address other potential bottlenecks, including vials, needles and syringes, and cold storage capacity.
:: Support for mapping COVID-19 vaccine manufacturing capacity, focusing especially on potential bottlenecks in manufacturing processes.

 

General information on the World Bank Group’s COVID-19 response:
As countries around the world work to contain the spread and impact of COVID-19, the World Bank Group has mounted the fastest and largest crisis response in its history to help developing countries strengthen their pandemic response and health care systems.

With the pandemic’s rapid spread into developing countries, the Bank Group delivered a record $45 billion in financial support between April and June 2020, reflecting the urgency of the crisis and the scale of demand. This represents over one-fourth of the $160 billion in financing that the Bank Group can make available through June 2021.  It is tailored to the health, economic, and social shocks that countries are facing, and includes over $50 billion of IDA resources on grant and highly concessional terms.

The Bank Group’s emergency support operations are helping over 100 developing countries save lives and detect, prevent, and respond to the pandemic.
Last Updated: Oct 14, 2020

COVID Vaccination Strategies/Guidance – European Commission

Milestones :: Perspectives :: Research

 

COVID Vaccination Strategies/Guidance – European Commission

Preparedness for COVID-19 vaccination strategies and vaccine deployment
COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL
Brussels, 15.10.2020 COM(2020) 680 final :: 16 pages

European Commission Press release
Coronavirus: Commission lists key steps for effective vaccination strategies and vaccines deployment
15 October 2020
… the Commission is presenting the key elements to be taken into consideration by Member States for their COVID-19 vaccination strategies in order to prepare the European Union and its citizens for when a safe and effective vaccine is available, as well as priority groups to consider for vaccination first.

President of the European Commission, Ursula von der Leyen, said: “A safe and effective vaccine is our best shot at beating coronavirus and returning to our normal lives. We have been working hard to make agreements with pharmaceutical companies and secure future doses. Now, we must ensure that once a vaccine is found, we are fully prepared to deploy it. With our Vaccination Strategy, we are helping EU countries prepare their vaccination campaigns: who should be vaccinated first, how to have a fair distribution and how to protect the most vulnerable. If we want our vaccination to be successful, we need to prepare now.”
In line with the 17 June EU Vaccines Strategy, the European Commission and Member States are securing the production of vaccines against COVID-19 through Advance Purchase Agreements with vaccine producers in Europe. Any vaccine will need to be authorised by the European Medicine Agency according to regular safety and efficacy standards. Member States should now start preparing a common vaccination strategy for vaccine deployment.
Member States should, among others, ensure:
:: capacity of vaccination services to deliver COVID-19 vaccines, including skilled workforce and medical and protective equipment;
:: easy and affordable access to vaccines for target populations;
:: deployment of vaccines with different characteristics and storage and transport needs, in particular in terms of cold chain, cooled transport and storage capacity;
:: clear communication on the benefits, risks and importance of COVID-19 vaccines to build public trust.

All Member States will have access to COVID-19 vaccines at the same time on the basis of population size. The overall number of vaccine doses will be limited during the initial stages of deployment and before production can be ramped up. The Communication therefore provides examples of unranked priority groups to be considered by countries once COVID-19 vaccines become available, including:
:: healthcare and long-term care facility workers;
:: persons over 60 years of age;
:: persons whose state of health makes them particularly at risk;
:: essential workers;
:: persons who cannot socially distance;
:: more disadvantaged socio-economic groups.

Whilst awaiting the arrival of approved vaccines against COVID-19, and in parallel to safeguarding the continuation of other essential healthcare and public health services and programmes, the EU must continue mitigating the transmission of the virus. This can be done through the protection of vulnerable groups and ensuring that citizens adhere to public health measures. Until then and most likely also throughout the initial vaccination rollout phases, non-pharmaceutical interventions, such as physical distancing, closure of public places and adapting the work environment, [1] will continue to serve as the main public health tools to control and manage COVID-19 outbreaks…

COVID 19 Vaccine Programs Update

Milestones :: Perspectives :: Research

 

COVID 19 Vaccine Programs Update

 

Pfizer – Our Science
Greater Clarity on COVID-19 Timelines
An Open Letter from Pfizer Chairman and CEO Albert Bourla
October 16, 2020
As we get closer to an important data readout from our COVID-19 vaccine program, I wanted to speak directly to the billions of people, millions of businesses and hundreds of governments around the world that are investing their hopes in a safe and effective COVID-19 vaccine to overcome this pandemic. I know there is a great deal of confusion regarding exactly what it will take to ensure its development and approval, and given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines for Pfizer’s and our partner BioNTech’s COVID-19 vaccine.

There are three key areas where, as with all vaccines, we must demonstrate success in order to seek approval for public use. First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients. Second and equally important, the vaccine must be proven safe, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine can be consistently manufactured at the highest quality standards….

So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November. All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.

The timelines above reflect our best estimates of when these important milestones could be achieved. For 171 years Pfizer has been known for our high-quality standards. Our purpose is to discover breakthroughs that change patients’ lives. I cannot think of a breakthrough that would be more meaningful to a greater number of people than an effective and safe COVID-19 vaccine.

 

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Dr. Reddy’s and RDIF receive approval to conduct clinical trial for Sputnik V vaccine in India
October 17, 2020
HYDERABAD, India–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) and Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, today announced that they have received approval from the Drug Control General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India. This will be a multi-center and randomized controlled study, which will include safety and immunogenicity study.
“We are pleased to collaborate with the Indian regulators and in addition to Indian clinical trial data, we will provide safety and immunogenicity study from the Russian phase 3 clinical trial. This data will further strengthen the clinical development of Sputnik V vaccine in India.”
Earlier in September 2020, Dr. Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr. Reddy’s upon regulatory approval in India…

 

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Moderna Receives Confirmation of Eligibility for Submission of Marketing Authorization Application to the European Medicines Agency for mRNA Vaccine Against COVID-19 (mRNA-1273)
Confirmation underscores Moderna’s commitment to make its vaccine available in the EU
October 14, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that it has received written confirmation from the European Medicine Agency (EMA) that mRNA-1273, the Company’s vaccine candidate against COVID-19, is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure. Confirmation of eligibility was given in response to the submission of a letter of intent enabling Moderna to evaluate the opportunity for submitting a Marketing Authorization Application (MAA) for mRNA-1273 with the EMA. This submission follows positive results from a preclinical viral challenge study and the positive interim analysis of the Phase 1 study of mRNA-1273 in healthy adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine…

Herd Immunity

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Herd Immunity

18 Public Health Organizations Condemn Herd Immunity Scheme for Controlling Spread of SARS-CoV-2
Great Barrington Declaration is not grounded in science and is dangerous
(Washington, DC – October 14, 2020) – SARS-CoV-2, the virus that causes COVID-19 has infected at least 7.8 million people in the United States and 38 million worldwide. It has led to over 215,000 deaths domestically, and more than 1 million globally – with deaths continuing to climb.

 

If followed, the recommendations in the Great Barrington Declaration would haphazardly and unnecessarily sacrifice lives. The declaration is not a strategy, it is a political statement. It ignores sound public health expertise. It preys on a frustrated populace. Instead of selling false hope that will predictably backfire, we must focus on how to manage this pandemic in a safe, responsible, and equitable way.

The suggestions put forth by the Great Barrington Declaration are NOT based in science.
:: There is no evidence that we are even remotely close to herd immunity. To the contrary, experts believe that 85 to 90 percent of the U.S. population is still at risk of contracting SARS-CoV-2. Herd immunity is achieved when the virus stops circulating because a large segment of the population has already been infected. Letting Americans get sick, rather than focusing on proven methods to prevent infections, could lead to hundreds of thousands of preventable illnesses and deaths.[i] It would also add greater risk in communities of color which have already experienced disproportionate impacts of the pandemic.

:: The declaration ignores what are our best tools to fight the virus, i.e. wearing masks, physical distancing, hand-washing, avoiding large crowds, strategic testing, rapid isolation of infected people and supportive quarantine for people who need to isolate.

:: We have seen the failure of the herd immunity experiment in nations such as Sweden, which has the highest mortality rate among Nordic countries.[ii] COVID-19 carries a much higher risk of severe disease and death than other infections where herd immunity was attempted before a vaccine was available.[iii] It is illogical to ignore public health and scientific evidence when so many lives are at stake.

Combatting the pandemic with lockdowns or full reopening is not a binary, either/or choice. We need to embrace common sense public health practices that allow for a safe reopening of the economy and a return to in-person work and learning while also using proven strategies to reduce the spread of the virus.

The declaration suggests a so-called focused protection approach. It suggests allowing the virus to spread unchecked among young people to create herd immunity in the entire population. This notion is dangerous because it puts the entire population, particularly the most vulnerable, at risk. Young people are not all healthy and they don’t live in vacuums.[iv] They interact with family members, co-workers and neighbors. Inviting increased rates of COVID-19 in young people will lead to increased infections rates among all Americans.

Public health guidance and requirements related to masking and physical distancing are not an impediment to normalcy – they are the path to a new normal. The goal is both public health safety and economic security; the two are not in conflict with one another, they are dependent on each other. We need to focus our efforts on the development and implementation of a national, science-based and ethical pandemic disease-control strategy.

The pandemic has created serious hardships on families’ economic security and on American’s mental health and well-being. What we need is a coordinated and robust national response including mask use, hand hygiene and physical distancing, while also ensuring social supports for those most vulnerable, including physical and mental health, and social factors.  What we do not need is wrong-headed proposals masquerading as science.

This statement was authored by:
American Public Health Association
Big Cities Health Coalition
Trust for America’s Health
American Academy of Social Work and Social Welfare
Association for Professionals in Infection Control and Epidemiology
Association of Public Health Laboratories
Association of Schools and Programs of Public Health
de Beaumont Foundation
Johns Hopkins Center for Health Security at the Bloomberg School of Public Health
Los Angeles County Department of Public Health
National Association of County Behavioral Health and Developmental Disabilities Directors
National Association of County and City Health Officials
National Association for Rural Mental Health
National Network of Public Health Institutes
Prevention Institute
Public Health Institute
Resolve to Save Lives, an initiative of Vital Strategies
Well Being Trust

COVID-19 Impacts

Milestones :: Perspectives :: Research

 

COVID-19 Impacts

Impact of COVID-19 on people’s livelihoods, their health and our food systems
Joint statement by ILO, FAO, IFAD and WHO
13 October 2020 [Editor’s text bolding]

The COVID-19 pandemic has led to a dramatic loss of human life worldwide and presents an unprecedented challenge to public health, food systems and the world of work. The economic and social disruption caused by the pandemic is devastating: tens of millions of people are at risk of falling into extreme poverty, while the number of undernourished people, currently estimated at nearly 690 million, could increase by up to 132 million by the end of the year.

Millions of enterprises face an existential threat. Nearly half of the world’s 3.3 billion global workforce are at risk of losing their livelihoods. Informal economy workers are particularly vulnerable because the majority lack social protection and access to quality health care and have lost access to productive assets. Without the means to earn an income during lockdowns, many are unable to feed themselves and their families. For most, no income means no food, or, at best, less food and less nutritious food.

The pandemic has been affecting the entire food system and has laid bare its fragility. Border closures, trade restrictions and confinement measures have been preventing farmers from accessing markets, including for buying inputs and selling their produce, and agricultural workers from harvesting crops, thus disrupting domestic and international food supply chains and reducing access to healthy, safe and diverse diets. The pandemic has decimated jobs and placed millions of livelihoods at risk. As breadwinners lose jobs, fall ill and die, the food security and nutrition of millions of women and men are under threat, with those in low-income countries, particularly the most marginalized populations, which include small-scale farmers and indigenous peoples, being hardest hit.

Millions of agricultural workers – waged and self-employed – while feeding the world, regularly face high levels of working poverty, malnutrition and poor health, and suffer from a lack of safety and labour protection as well as other types of abuse. With low and irregular incomes and a lack of social support, many of them are spurred to continue working, often in unsafe conditions, thus exposing themselves and their families to additional risks. Further, when experiencing income losses, they may resort to negative coping strategies, such as distress sale of assets, predatory loans or child labour. Migrant agricultural workers are particularly vulnerable, because they face risks in their transport, working and living conditions and struggle to access support measures put in place by governments. Guaranteeing the safety and health of all agri-food workers – from primary producers to those involved in food processing, transport and retail, including street food vendors – as well as better incomes and protection, will be critical to saving lives and protecting public health, people’s livelihoods and food security.

In the COVID-19 crisis food security, public health, and employment and labour issues, in particular workers’ health and safety, converge. Adhering to workplace safety and health practices and ensuring access to decent work and the protection of labour rights in all industries will be crucial in addressing the human dimension of the crisis. Immediate and purposeful action to save lives and livelihoods should include extending social protection towards universal health coverage and income support for those most affected. These include workers in the informal economy and in poorly protected and low-paid jobs, including youth, older workers, and migrants. Particular attention must be paid to the situation of women, who are over-represented in low-paid jobs and care roles. Different forms of support are key, including cash transfers, child allowances and healthy school meals, shelter and food relief initiatives, support for employment retention and recovery, and financial relief for businesses, including micro, small and medium-sized enterprises. In designing and implementing such measures it is essential that governments work closely with employers and workers.

Countries dealing with existing humanitarian crises or emergencies are particularly exposed to the effects of COVID-19. Responding swiftly to the pandemic, while ensuring that humanitarian and recovery assistance reaches those most in need, is critical.

Now is the time for global solidarity and support, especially with the most vulnerable in our societies, particularly in the emerging and developing world. Only together can we overcome the intertwined health and social and economic impacts of the pandemic and prevent its escalation into a protracted humanitarian and food security catastrophe, with the potential loss of already achieved development gains.

We must recognize this opportunity to build back better, as noted in the Policy Brief issued by the United Nations Secretary-General. We are committed to pooling our expertise and experience to support countries in their crisis response measures and efforts to achieve the Sustainable Development Goals. We need to develop long-term sustainable strategies to address the challenges facing the health and agri-food sectors. Priority should be given to addressing underlying food security and malnutrition challenges, tackling rural poverty, in particular through more and better jobs in the rural economy, extending social protection to all, facilitating safe migration pathways and promoting the formalization of the informal economy.

We must rethink the future of our environment and tackle climate change and environmental degradation with ambition and urgency. Only then can we protect the health, livelihoods, food security and nutrition of all people, and ensure that our ‘new normal’ is a better one.

 

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Policy Brief: The Impact of COVID-19 on Food Security and Nutrition
United Nations
JUNE 2020 :: 23 pages
The COVID-19 pandemic is a health and human crisis threatening the food security and nutrition of millions of people around the world. Hundreds of millions of people were already suffering from hunger and malnutrition before the virus hit and, unless immediate action is taken, we could see a global food emergency. In the longer term, the combined effects of COVID-19 itself, as well as corresponding mitigation measures and the emerging global recession could, without large-scale coordinated action, disrupt the functioning of food systems.
Such disruption can result in consequences for health and nutrition of a severity and scale unseen for more than half a century.

CONCLUSION
The COVID-19 crisis threatens the food security and nutrition of millions of people, many of
whom were already suffering. A large global food emergency is looming. In the longer term,
we face possible disruptions to the functioning of food systems, with severe consequences for
health and nutrition. With concerted action, we can not only avoid some of the worst impacts
but do so in a way that supports a transition to more sustainable food systems that are in better balance with nature and that support healthy diets – and thus better health prospects – for all.

Coronavirus [COVID-19] Public Health Emergency of International Concern (PHEIC)

EMERGENCIES

 

Coronavirus [COVID-19]
Public Health Emergency of International Concern (PHEIC)

 

Weekly Epidemiological and Operational updates
last update: 8 October 2020, 20:00 GMT-4
Confirmed cases :: 39 023 292 [week ago: 36 754 395 :: two weeks ago: 34 495 176]
Confirmed deaths :: 1 099 586 [week ago 1 064 838 :: two weeks ago: 1 025 729]
Countries, areas or territories with cases :: 235

WHO Director-General’s opening remarks at the media briefing on COVID-19 – 16 October 2020
16 October 2020
:: Interim results from the Solidarity Therapeutics Trial  now show that the other two drugs in the trial, remdesivir and interferon, have little or no effect in preventing death from COVID-19 or reducing time in hospital.
:: For the moment, the corticosteroid dexamethasone is still the only therapeutic shown to be effective against COVID-19, for patients with severe disease.
:: Although the number of deaths reported in Europe last week is much lower than in March, hospitalizations are increasing and many cities are reporting they will reach their intensive care bed capacity in the coming weeks.
:: During this year’s southern hemisphere winter, the number of seasonal flu cases and deaths was less than usual because of the measures put in place to contain COVID-19. But we cannot assume the same will be true in the northern hemisphere flu season.
:: Demand for influenza vaccines may outstrip supply in some countries. The Strategic Advisory Group of Experts on Immunization has therefore recommended that, among the five risk groups, health workers and older adults are the highest priority groups for influenza vaccination during the COVID-19 pandemic. Another under-utilized tool is the use of antivirals to treat people with influenza. We encourage all countries to use all the tools at their disposal.
:: Today is World Hypertension Day. To support countries to take action against cardiovascular diseases, WHO has developed the HEARTS package, which outlines the six key ingredients for addressing threats to heart health, including hypertension.

Weekly Epidemiological Update
Coronavirus disease 2019 (COVID-19)
12 October 2020
Global epidemiological situation
Since the last Weekly Epidemiological Update issued on 5 October, over 2.2 million new cases and 39,000 deaths of COVID-19 have been reported across all six WHO regions. This is the highest number of reported cases so far in a single week.
From 30 December through 11 October, over 37 million COVID-19 cases and 1 million deaths have been reported globally. Nearly half of these cases (48%) and deaths (55%) continue to be reported in the Region of the Americas with the United States of America, Brazil and Argentina accounting for the greatest numbers of new cases and deaths in the region…

 

Key weekly updates
At WHOs Executive Board meeting, WHO Director-General Dr Tedros highlighted some of WHO’s key actions over the course of the pandemic:
:: Publishing the first Strategic Preparedness and Response Plan 4 days later;
:: Producing and shipping the diagnostic tests within a month of declaring the outbreak, with millions of tests distributed to more than 150 countries since then;
:: Publishing more than 400 guidance documents for individuals, communities, schools, businesses, industries, health workers, health facilities and governments;
:: Building country capacity by providing free training in 133 COVID-19 courses on OpenWHO.org;
:: Working closely with governments to write national plans and identify needs, and to match those needs with more than 600 partners and 74 donors through the COVID-19 Partners :: :: :: :: Sending expert missions to more than 130 countries to provide operational and technical support;
:: Sourcing, validating, purchasing and delivering masks, gloves, respirators, gowns, goggles, swabs, tests, reagents, thermometers, oxygen concentrators, ventilators and more, to 177 countries and territories;
:: Enrolling more than 12,000 patients in the WHO Solidarity Therapeutics Trial, in nearly 500 hospitals in 29 countries; and
:: Launching the Access to COVID-19 Tools Accelerator, which is working on diagnostics, treatment, vaccines and health system strengthening. It includes COVAX which is supporting the development of 9 vaccines, with more in the pipeline and aims to fairly distribute 2 billion vaccine doses by the end of 2021…

 

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::::::

WHO appoints co-chairs of Independent Commission on sexual misconduct during the Ebola response in North Kivu and Ituri, the Democratic Republic of the Congo

Emergencies

WHO appoints co-chairs of Independent Commission on sexual misconduct during the Ebola response in North Kivu and Ituri, the Democratic Republic of the Congo
15 October 2020
The World Health Organization has appointed two distinguished leaders to co-chair an Independent Commission on sexual abuse and exploitation during the response to the tenth Ebola Virus Disease epidemic in the provinces of North Kivu and Ituri, the Democratic Republic of the Congo.

The commission will be co-chaired by Her Excellency Aïchatou Mindaoudou, former minister of foreign affairs and of social development of Niger, who has held senior United Nations posts in Côte d’Ivoire and in Darfur.

She will be joined by co-chair Julienne Lusenge of the Democratic Republic of the Congo, an internationally recognized human rights activist and advocate for survivors of sexual violence in conflict.

The role of the Independent Commission will be to swiftly establish the facts, identify and support survivors, ensure that any ongoing abuse has stopped, and hold perpetrators to account.

It will comprise up to seven members, including the co-chairs, with expertise in sexual exploitation and abuse, emergency response, and investigations.

The co-chairs will choose the other members of the Commission, which will be supported by a Secretariat based at WHO.

To support the Independent Commission’s work, the Director-General has decided to use an open process to hire an independent and external organization with experience in conducting similar inquiries.

The tenth epidemic of Ebola Virus Disease in the provinces of North Kivu and Ituri – the world’s second largest Ebola outbreak on record – was declared over on 25 June 2020, after persisting for nearly two years in an active conflict zone, and causing 2,300 deaths.

WHO has a zero tolerance policy with regard to sexual exploitation and abuse. We reiterate our strong commitment to preventing and protecting against sexual exploitation and abuse in all our operations around the world.

 

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::::::

Emergencies

Emergencies

 

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 14 October 2020
:: Dear polio eradication supporter, last month I was delighted to join a very long-awaited celebration at the WHO African Regional Committee of a global public health milestone… Read more of Polio Oversight Board Chair’s quarterly letter.
::Take a look at the newly published nOPV2 technical brief that provides a quick summary of the key operational considerations for the use of nOPV2 in outbreak response as a quick reference for EPI managers, immunization focal points, and field staff.

Summary of new WPV and cVDPV viruses this week (AFP cases and environmental samples):
:: Afghanistan: one WPV1 case, one WPV1positive environmental sample and 11 cVDPV2 positive environmental samples
:: Pakistan: three WPV1 cases, three WPV1 positive environmental samples and 10 cVDPV2 positive environmental samples
:: Burkina Faso: one cVDPV2 AFP case
:: Côte d’Ivoire: four cVDPV2 cases
:: Guinea: eleven cVDPV2 cases
:: Mali: four cVDPV2 cases
:: Niger: three cVDPV2 AFP cases

 

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::::::

WHO Grade 3 Emergencies [to 17 Oct 2020]

Democratic Republic of the Congo
:: WHO appoints co-chairs of Independent Commission on sexual misconduct during the Ebola response in North Kivu and Ituri, the Democratic Republic of the Congo 15 October 2020
[See Milestones above for detail]

Mozambique floods – No new digest announcements identified
Nigeria – No new digest announcements identified
Somalia – No new digest announcements identified
South Sudan – No new digest announcements identified
Syrian Arab Republic – No new digest announcements identified
Yemen – No new digest announcements identified

 

::::::

WHO Grade 2 Emergencies [to 17 Oct 2020]
Iraq
:: Hevi Paediatric Teaching Hospital: A story of lifesaving services 14 Oct 2020
…One of the projects nurtured by this approach was the renovation of Hevi Paediatric Teaching Hospital, with a focus on the expansion of the paediatric intensive care unit and the harmonization and maintenance of the paediatric wards in the hospital, built 16 years ago…

Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burkina Faso [in French] – No new digest announcements identified
Burundi – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Ethiopia – No new digest announcements identified
Iran floods 2019 – No new digest announcements identified
Libya – No new digest announcements identified
Malawi Floods – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Mozambique – No new digest announcements identified
Myanmar – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

 

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WHO Grade 1 Emergencies [to 17 Oct 2020]

Chad – No new digest announcements identified
Djibouti – Page not responding at inquiry
Kenya – No new digest announcements identified
Mali – No new digest announcements identified
Namibia – viral hepatitis – No new digest announcements identified
Tanzania – No new digest announcements identified

 

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::::::

UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: Syrian Arab Republic: North East Syria: Al Hol camp As of 11 October 2020
:: OCHA Syria Flash Update #01 Humanitarian Impact of Wildfires in Coastal Areas As of 11 October 2020

Yemen
:: 14 October 2020 Yemen: COVID-19 Preparedness and Response Monthly Report (September 2020)

 

::::::

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
COVID-19
::  Coronavirus disease 2019 (COVID-19) Situation Report 48: occupied Palestinian territory, issued 15 October 2020, information for period: 5 March – 15 October 2020

East Africa Locust Infestation
:: Desert Locust situation update – 14 October 2020

 

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::::::

WHO & Regional Offices [to 17 Oct 2020]

WHO & Regional Offices [to 17 Oct 2020]
15 October 2020 Departmental news
WHO Bulletin Call for Papers: Behavioural and Social Sciences for Better Health

15 October 2020 News release
WHO appoints co-chairs of Independent Commission on sexual misconduct during the Ebola response in North Kivu and Ituri, the Democratic Republic of the Congo

15 October 2020 Departmental news
New electronic survey manual supports countries to combat micronutrient deficiencies

14 October 2020 Departmental news
Sixth Annual meeting of the “Friends of the Task Force” Working with Member States to deliver the NCD-related SDG targets during and beyond COVID-19

14 October 2020 Departmental news
WHO takes a position on genetically modified mosquitoes
Position statement 
In recent years, there have been significant advances in GMM approaches aimed at suppressing mosquito populations and reducing their susceptibility to infection, as well as their ability to transmit disease-carrying pathogens. These advances have led to an often polarized debate on the benefits and risks of genetically modified mosquitoes.
According to the WHO statement, computer simulation modelling has shown that GMMs could be a valuable new tool in efforts to eliminate malaria and to control diseases carried by Aedes mosquitoes. WHO cautions, however, that the use of GMMs raises concerns and questions around ethics, safety, governance, affordability and cost–effectiveness that must addressed.
The statement notes that GMM research should be conducted through a step-wise approach and supported by clear governance mechanisms to evaluate any health, environmental and ecological implications. It underscores that any effective approach to combating vector-borne diseases requires the robust and meaningful engagement of communities. This is especially important for area-wide control measures such as GMMs, as the risks and benefits may affect large segments of the population.
Countries and other stakeholders are encouraged to provide feedback on the new position statement by contacting WHO at: geneticallymodifiedmosquitoes@who.int
New guidance
Despite the growing threat of vector-borne diseases to individuals, families and societies, the ethical issues raised by vector-borne diseases have received only limited attention. Recognizing this gap, WHO has issued new guidance to support national VBD control programmes in their efforts to identify and respond to the core ethical issues at stake.
The new guidance, titled Ethics & vector-borne diseases, was issued today alongside the position statement on genetically modified mosquitoes. Grounded in a multidisciplinary framework, the guidance emphasizes the critical role of community engagement in designing and implementing an appropriate, sustainable public health response.

14 October 2020 News release
WHO: Global TB progress at risk

14 October 2020 Departmental news
Investment in digital health needs careful planning: new WHO guide explains how to do it well

14 October 2020 Departmental news
Release of module and mapping of tools on stakeholder and community engagement in quality of care initiatives for maternal, newborn and child health

13 October 2020 Statement
Impact of COVID-19 on people’s livelihoods, their health and our food systems

12 October 2020 Departmental news
WHO publishes guidance on climate resilient and environmentally sustainable health care facilities

12 October 2020 Departmental news
Neglected tropical diseases: tackling stigmatization, discrimination and mental health through a person-centred approach

 

::::::

WHO Strategic Advisory Group of Experts on immunization (SAGE) : Request for nominations
16 October 2020
WHO is soliciting proposals for nominations of two new experts to serve on its Strategic Advisory Group of Experts (SAGE) on immunization. Deadline for applications: 22 November 2020
The new SAGE members’ appointment, for an initial period of three years, is scheduled for the first quarter of 2021.
WHO is seeking nominations particularly from the WHO South-East Asia and Western-Pacific Regions. Nominations of women and persons from low- and middle-income countries are specifically encouraged. A track record of achievements on implementation research and social sciences would be of particular relevance…

 

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Weekly Epidemiological Record, 9 October 2020, vol. 95, 41 (pp. 489–496)
Progress towards poliomyelitis eradication – Afghanistan, January 2019–July 2020

 

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Keeping displaced persons safe from COVID-19 in South Sudan 13 October 2020

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
:: Handwashing an effective tool to prevent COVID-19, other diseases 15 October 2020 News release

WHO European Region EURO
:: Providing an update on the COVID-19 situation 15-10-2020
:: Bringing sexual and reproductive health services to young people across the Republic of Moldova 15-10-2020
:: Governments across the WHO European Region contribute over US$ 749 million to the COVID-19 global response 15-10-2020

WHO Eastern Mediterranean Region EMRO
:: Statement of the WHO Regional Director for the Eastern Mediterranean on the closing of the 67th session of the Regional Committee
13 October 2020 – I am pleased at the outset to welcome Her Excellency Dr. Hala Zayed, Minister of Health and Population of Egypt, and to congratulate Her Excellency on her election as Chair of the 67th session of the Regional Committee for the Eastern Mediterranean. The 67th session of the WHO Regional Committee for the Eastern Mediterranean has just concluded.
:: COVID-19 dominates discussion of the 67th WHO Regional Committee for the Eastern Mediterranean
Cairo 12 October 2020 ‒ The annual meeting of the WHO Regional Committee for the Eastern Mediterranean began on Monday, 12 October 2020 with a strong focus on the ongoing COVID-19 pandemic. Ministers and representatives from across the Region discussed the impact of the pandemic on health systems and society more generally, and the conference itself was impacted by the pandemic,…
:: Virtual 67th session of the WHO Regional Committee for the Eastern Mediterranean
11 October 2020, Cairo ‒ Due to the COVID-19 pandemic, the 67th session of the WHO Regional Committee for the Eastern Mediterranean will be held virtually for the first time ever. Health ministers and high-level representatives of the 22 countries of WHO’s Eastern Mediterranean Region, along with partner organizations and civil society, will connect online to discuss health issues during…

WHO Western Pacific Region
No new digest content identified

CDC/ACIP [to 17 Oct 2020]

CDC/ACIP [to 17 Oct 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements

Coronavirus Disease 2019 (COVID-19)
:: EARLY RELEASE: Race, Ethnicity, and Age Trends in Persons Who Died from COVID-19 – United States, May-August 2020 Friday, October 16, 2020
:: COVIDView Weekly Summary Friday, October 16, 2020
:: 10 Things Healthcare Professionals Need to Know about U.S. COVID-19 Vaccination Plans Wednesday, October 14, 2020
:: Frequently Asked Questions about COVID-19 Vaccination Wednesday, October 14, 2020
:: Vaccines Wednesday, October 14, 2020

MMWR News Synopsis Friday, October 16, 2020
:: Demographic Characteristics, Experiences, and Beliefs Associated with Hand Hygiene Among Adults During the COVID-19 Pandemic — United States, June 24–30, 2020
:: An Outbreak of COVID-19 Associated with a Recreational Hockey Game — Florida, June 2020
:: Transmission Dynamics by Age Group in COVID-19 Hotspot Counties — United States, April–September 2020 (Early release October 9, 2020)
:: Factors Influencing Risk for COVID-19 Exposure Among Young Adults Aged 18-23 Years — Winnebago County, Wisconsin, March–July 2020 (Early release October 9, 2020)

China CDC

China CDC
http://www.chinacdc.cn/en/
No new digest content identified.

 

National Health Commission of the People’s Republic of China
http://en.nhc.gov.cn/
News
Oct 17: Daily briefing on novel coronavirus cases in China
On Oct 16, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 13 new cases of confirmed infections.

Beijing requires 3 nucleic acid tests for overseas travelers
2020-10-15

Chinese delegation attends special session of WHO Executive Board
2020-10-11
…The Chinese delegation hailed the WHO’s commitment in response to the COVID-19 pandemic and its implementation of the resolution of the World Health Assembly. They also praised the work the IPPR, the IHR Review Committee, and the IOAC have carried out in an open and transparent manner.
The delegation expressed its willingness to further support the implementation of the WHO’s responsibilities, and called on all the parties to unite to tackle the challenges of COVID-19, assist developing countries in improving their core capacities to implement the IHR, and work together to build a global health community for all…

World Health Organization Conference: China joins COVAX
2020-10-11
On Oct 9, Tedros Adhanom Ghebreyesus, director general of the World Health Organization announced that China, the Republic of Korea and Nauru joined the COVAX Facility this week.

Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 17 Oct 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
Press Release
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 17 Oct 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
October 13, 2020: Trump Administration Expands Manufacturing Capacity with Cytiva for Components of COVID-19 Vaccines
To meet the Trump Administration’s Operation Warp Speed goals, the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD ) today announced an agreement with Cytiva, headquartered in Massachusetts, to expand the company’s manufacturing capacity for products that are essential in producing COVID-19 vaccines…

 

BMGF – Gates Foundation [to 17 Oct 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 17 Oct 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
Review ARTICLE
Front. Immunol., 14 October 2020 | https://doi.org/10.3389/fimmu.2020.517290
Challenges of Developing Novel Vaccines With Particular Global Health Importance
Penny M. Heaton, Bill & Melinda Gates Medical Research Institute, Cambridge, MA, United States
Six of the top ten leading causes of death in low resource settings could potentially be prevented by vaccination. Development of vaccines for individuals in these populations is difficult because of the biological complexity of the prevalent pathogens and the challenges inherent to development of any vaccine. This review discusses those challenges and promising advances to address them and highlights recent progress in development of vaccines against several pathogens of interest.

 

CARB-X [to 17 Oct 2020]
https://carb-x.org/
News
10.14.2020  |
CARB-X is funding Polyphor to develop a new antibiotic to treat multidrug-resistant Enterobacteriaceae Gram-negative bacterial infections
CARB-X is awarding up to US$2.62 million to Polyphor AG (SIX:POLN), headquartered in Allschwil, Switzerland, to develop a new antibiotic to treat serious Enterobacteriaceae Gram-negative bacterial infections, including those caused by life-threatening carbapenem-resistant Enterobacteriaceae (CRE).

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 17 Oct 2020]
http://cepi.net/
Latest News
Private sector companies provide financial support for CEPI’s COVID-19 vaccine programmes
14 Oct 2020 By Jodie Rogers
As CEPI continues to advance its COVID-19 vaccine portfolio to respond to the global crisis, private sector companies have stepped up and pledged financial support to fund CEPI’s vital work.
This includes donations from Nestlé, Sumitomo Mitsui Financial Group, Inc. (SMFG), Founders Pledge, ADX Labs, Beiersdorf, and A Collected Man, among other supporting organisations.
Financial contributions from our private sector partners will be used to support CEPI’s vaccine development and manufacturing efforts. Based on the principles of speed, scale, and access, CEPI has provided up to US $895 million in funding to date to accelerate the development of nine COVID-19 vaccine programmes, with eight of our partners having already entered clinical trials. Through taking an active portfolio management approach, CEPI is seeking to invest in further COVID-19 vaccine candidates to increase the number of shots on goal in our search for a safe and effective COVID-19 vaccine.

 

EDCTP [to 17 Oct 2020]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
No new digest content identified.

 

Emory Vaccine Center [to 17 Oct 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 17 Oct 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: First long-acting injectable antiretroviral therapy for HIV recommended for approval
CHMP, Last updated: 16/10/2020

 

 

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2020
CHMP, Last updated: 16/10/2020

 

European Vaccine Initiative [to 17 Oct 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 17 Oct 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
October 15, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 15, 2020

October 14, 2020 – FDA Approves First Treatment for Ebola Virus

October 13, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 13, 2020

 

FDA – COVID-19 Vaccines [to 17 Oct 2020]
www.fda.gov/covid19vaccines
Upcoming Events
Vaccines and Related Biological Products Advisory Committee Meeting
10/22/2020 Virtual
Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On October 22, 2020, the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting.

 

Fondation Merieux [to 17 Oct 2020]
http://www.fondation-merieux.org/
News, Events
October 20 – 21 2020
Mérieux Foundation co-organized event
7th Global Task Force on Cholera Control (GTFCC) Annual Meeting
Virtual

October 30 – November 3 2020
Mérieux Foundation co-organized event
6th World One Health Congress 2020 – Virtual Event
Virtual

 

Gavi [to 17 Oct 2020]
https://www.gavi.org/
News releases
16 October 2020
Gavi receives 2020 Princess of Asturias Award for International Cooperation
The Princess of Asturias Foundation recognises Gavi “…for their work in facilitating universal access to vaccines to reduce the impact of infectious diseases and for contributing to the protection of half of the global child population through vaccination routines.”
The presentation of the awards, presided over by TM the King and Queen and with the presence of TRH The Princess of Asturias and the Infanta Sofía, took place as a virtual event in Asturias, Spain on 16 October. Gavi CEO Dr Seth Berkley accepted the award on behalf of Gavi.

15 October 2020
Why handwashing with soap is the most effective way to stop viruses
We may not yet have vaccines or treatments against COVID-19, but there is one powerful combo that can help stop the spread of the virus, which many of us already have access to: soap and water.
There’s a reason why governments and public health experts worldwide have been telling us to wash our hands – it really works. Good hand hygiene could reduce cases of respiratory diseases by 20%, and diarrhoea by 30%. That means it has potential to have a huge impact on the spread of the coronavirus.

13 October 2020
Strong systems for strong vaccine coverage
With support from the Vaccine Alliance, countries provided more than 400 million campaign and routine vaccinations in 2019. At the same time, Gavi disbursed a record US$ 331 million in health system support. This is nearly double the level of US$ 172 million in 2015, at the end of the previous five-year strategic period, and a significant increase from US$ 284 million in 2018. In June 2018, the Gavi Board agreed to make available additional HSS funding to countries with unmet needs to strengthen coverage and equity; 30 countries were approved in 2019 for a total of US$ 238 million, with a strong focus on extending immunisation to reach under-served communities..

 

GHIT Fund [to 17 Oct 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.

 

Global Fund [to 17 Oct 2020]
https://www.theglobalfund.org/en/news/
News/Updates
Results Report 2020 Executive Summary and Translations
15 October 2020
An executive summary and translations of the Global Fund Results Report 2020 are now available for download:
Full Report – download in English | Français

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 17 Oct 2020]
https://www.glopid-r.org/news/
News
No new digest content identified.

 

Hilleman Laboratories [to 17 Oct 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 17 Oct 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.

 

IAVI [to 17 Oct 2020]
https://www.iavi.org/newsroom
No new digest content identified.

 

 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
No new digest content identified.

 

 

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
No new digest content identified.

 

 

IFFIm
http://www.iffim.org/
Announcements
No new digest content identified.

 

IFRC [to 17 Oct 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Sudan
Sudan floods: “The conditions are simply appalling” says IFRC Secretary General, as emergency appeal remains woefully underfunded
Geneva, 15 October – The Secretary General of the International Federation of Red Cross and Red Crescent (IFRC) has returned from Sudan, where unprecedented flooding has killed more than 100 people and left over 875,000 people in need of humanitarian a …
15 October 2020

Europe, France, Italy, Netherlands, Spain, United Kingdom
Red Cross raises the alarm across Europe: “Your best defence against this virus is you”
Budapest/Geneva, 14 October 2020 – The International Federation of Red Cross and Red Crescent Societies (IFRC) is urging European governments and its citizens to simultaneously exercise leadership and remain vigilant as COVID-19 ravages the region. Mor …
14 October 2020

Asia Pacific, Vietnam
One million swamped by deadly floods as Viet Nam faces another major storm
Hanoi, Viet Nam, October 14, 2020 – Close to a million people have been severely affected by prolonged flooding in central Viet Nam as the country faces another major tropical storm and further dangerous floods. Red Cross holds grave fears that deadly …
14 October 2020

 

IRC International Rescue Committee [to 17 Oct 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Statement
Humanitarian leaders call on global donors to fund nutrition crisis on World Food Day
October 16, 2020

Press Release
El Comité Internacional de Rescate y los compañeros de tecnología lanzaron un iniciativo digital para combatir la desinformación entregada a los refugiados venezolanos y las poblaciones desplazadas en Colombia
[The International Rescue Committee and technology partners launched a digital initiative to combat misinformation delivered to Venezuelan refugees and displaced populations in Colombia]
October 16, 2020

Press Release
New Report Finds 73% of Refugee and Displaced Women Reported an Increase in Domestic Violence Due to COVID-19
October 15, 2020

Press Release
As US and UK struggle to contain COVID-19, conflict-affected states show encouraging signs in slowing virus transmission – IRC
October 14, 2020

 

IVAC [to 17 Oct 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
IVAC Support for SAGE October 2020 Meeting
October 2020
WHO’s Strategic Advisory Group of Experts (SAGE) on Immunizations met October 5-7, 2020 to discuss topics including the use of pneumococcal vaccines in older adults, expanded recommendations on rotavirus vaccines, the impact of the pandemic on immunization, and the Immunization Agenda 2030. IVAC regularly participates in semiannual SAGE meetings, providing research summaries and other assistance to […]

 

IVI [to 17 Oct 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
IVI and global health partners encourage vaccine diplomacy
October 13, 2020, SEOUL, Korea — The International Vaccine Institute (IVI) hosted a virtual State Forum today to advocate for multilateral cooperation through vaccine diplomacy. During a coronavirus pandemic with the continuous threat of more neglected infectious diseases spreading around the world, the forum convened a panel of country ambassadors and vaccine experts to promote partnership and equity in global health.

“Our coming together today is visible evidence of the kind of solidarity that will end this pandemic, prevent the next one, and control and eradicate more neglected diseases that disproportionately affect low- and middle-income countries,” said George Bickerstaff, Chair of IVI’s Board of Trustees, in his welcome.

The forum was livestreamed online from IVI headquarters in Seoul, Korea and featured remarks from First Lady Kim Jung-sook of the Republic of Korea and Queen Sylvia of Sweden, as well as ambassadors from the Republic of Korea, Sweden, India, Finland, Mexico, and Pakistan. A panel of leaders in global health urged support for stronger partnership, including Dr. Soumya Swaminathan, Chief Scientist of the World Health Organization; Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance; Dr. Richard J. Hatchett, CEO of CEPI; Ms. Etleva Kadilli, Director of the Supply Division at UNICEF; and Dr. Peter Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine.

IVI’s 2020 annual State Forum commemorated the international organization’s founding in October of 1997 under the theme of “Building Vaccine Diplomacy and Advocacy.” Dr. Jerome Kim, Director General of IVI, presented on IVI’s approach to sustainable vaccine development, highlighting South-South and Triangular Cooperation as catalysts for diplomacy and making available life-saving vaccines.

“Ending the COVID-19 pandemic and ridding the world of other dangerous though ‘neglected’ infectious diseases will require countries to commit to vaccine diplomacy with the support and partnership of the scientific community, international organizations, and industry,” said Dr. Jerome Kim.

The IVI State Forum 2020 was livestreamed on October 13, 2020 at 5:00 PM Korea Standard Time, and a recording of the event may be accessed here.

 

JEE Alliance [to 17 Oct 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 17 Oct 2020]
http://www.msf.org/
Latest [Selected Announcements]
Venezuela
MSF teams improve conditions for Venezuelan returnees in quarantine centres…
Project Update 13 Oct 2020

 

National Vaccine Program Office – U.S. HHS [to 17 Oct 2020]
https://www.hhs.gov/vaccines/about/index.html
No new digest content identified.

 

NIH [to 17 Oct 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH begins large clinical trial to test immune modulators for treatment of COVID-19
October 16, 2020 — The trial expects to enroll approximately 2,100 hospitalized adults with moderate to severe COVID-19 at medical facilities in the United States and Latin America.

NIH study aims to identify promising COVID-19 treatments for larger clinical trials
October 13, 2020 — The ACTIV-5 Big Effects Trial will enroll adult volunteers hospitalized with COVID-19.

 

 

NHGRI researchers work with patients, families and the scientific community to improve the informed consent process
October 13, 2020 — As genome-editing trials become more common, informed consent is changing.

 

PATH [to 17 Oct 2020]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

 

Sabin Vaccine Institute [to 17 Oct 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 17 Oct 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
16 October 2020
COVID-19’s impact on HIV treatment less severe than feared

15 October 2020
Chatbot answers young people’s questions about HIV, health and relationships

14 October 2020
UNAIDS saddened by the death of Guillermo Soberon

13 October 2020
Chinese young people take centre stage on HIV prevention

13 October 2020
COVID-19 impacting HIV testing in most countries

12 October 2020
New HIV infections: men outnumber women

 

UNICEF [to 17 Oct 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Statement
10/15/2020
Remarks by UNICEF Executive Director Henrietta Fore at the High-Level Special Event on Strengthening Global Governance of Food Security and Nutrition
As prepared for delivery

Statement
10/15/2020
Remarks by Henrietta H. Fore, UNICEF Executive Director, at the Global Handwashing Day: Accelerating Toward Hand Hygiene for All Event
As prepared for delivery

Press release
10/14/2020
FACT SHEET: Lack of handwashing with soap puts millions at increased risk to COVID-19 and other infectious diseases

 

Unitaid [to 17 Oct 2020]
https://unitaid.org/
Featured News
13 October 2020
Unitaid supports call for intellectual property waivers and action for access to COVID-19 products
Geneva – Unitaid calls on countries to take the necessary measures to facilitate and promote access to vaccines, therapeutics and diagnostics that will help fight the COVID-19 pandemic. This should include ensuring that they have the legal and health systems in place that enable fast production, importation, registration and deployment of effective products, once these become available.

In this context, Unitaid welcomes the proposal submitted by India and South Africa to the TRIPS Council for a temporary waiver on copyrights, industrial designs, patents, lay-out designs of integrated circuits and trade secrets/undisclosed information for products to prevent, contain or treat COVID-19.

Every solution that helps remove potential access barriers is welcome according to Marisol Touraine, Chair of the Unitaid Executive Board and former French Minister of Health, and will help countries to face the pandemic with new tools.

Marisol Touraine stressed that, “the waiver will not solve all challenges, but it is an important step. While countries and companies also need to do their part, this sends a clear message that we are facing an urgent and exceptional situation, that requires exceptional measures.”

Unitaid believes that a range of solutions will be needed in order to ensure that people across the globe have access to the products needed to combat COVID-19. “Just as we will need a range of products – such as protective equipment, tests, medicines and vaccines – to tackle COVID-19, we will need multiple approaches to ensuring access”, said  Dr Philippe Duneton, Unitaid Executive Director a.i., “Information sharing, voluntary licensing, technology transfer, flexibilities and waivers can all contribute to expanding access.”

 

Vaccination Acceptance Research Network (VARN) [to 17 Oct 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 17 Oct 2020]
http://www.vaccineconfidence.org/
Research and Reports
She Hunts Viral Rumors About Real Viruses
17 Oct 2020, New York Times
For Heidi Larson, the founder of the Vaccine Confidence Project, dispelling vaccine hesitancy means building trust — and avoiding the term “anti-vaxxer.”

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 17 Oct 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 17 Oct 2020]
https://wellcome.ac.uk/news
Opinion | 13 October 2020
Once we have effective Covid-19 treatments, it shouldn’t only be the rich who benefit
Jeremy Farrar, Director, Wellcome
We need a range of treatments to make Covid-19 preventable and treatable. Jeremy Farrar describes recent progress made by research and why more investment is needed.

Opinion | 12 October 2020
More people should have access to monoclonal antibodies. Covid-19 can make that happen
Lindsay Keir, Partner, Innovations team Wellcome
Monoclonal antibodies, one of the most promising treatments for Covid-19, are usually expensive and not available worldwide. Lindsay Keir highlights what needs to be done to change that.

 

The Wistar Institute [to 17 Oct 2020]
https://www.wistar.org/news/press-releases
Press Releases
Oct. 13, 2020
Advancement of Anticancer Compounds for B Cell Cancer Therapy Targeting a Cellular Stress Response Mechanism
IRE-1 inhibitors block a main pathway in the endoplasmic reticulum stress response that supports cell survival under stressful conditions and is important for B cell cancer development.

 

WFPHA: World Federation of Public Health Associations [to 17 Oct 2020]
https://www.wfpha.org/
Latest News
2019-2020 Annual report is now available!
Oct 13, 2020 | News
Here you’ll learn about our major initiatives from the past 12 months, explore our achievements in advancing public health globally and have an insight of our plan for the next year.

 

World Organisation for Animal Health (OIE) [to 17 Oct 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

 

 

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ARM [Alliance for Regenerative Medicine] [to 17 Oct 2020]
https://alliancerm.org/press-releases/
Press Releases
ARM and NAMCP Publish Recommendations to Increase Patient Access in Joint Study, “Roadmap for Navigating the Provider Side of Cell and Gene Therapy (CGT) Patient Access in US Managed Care.”
October 12, 2020
Washington, DC

 

BIO [to 17 Oct 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 17 Oct 2020]
http://www.dcvmn.org/
News; Upcoming events
DCVMN establishes an international consortium of laboratories to study the in-house validation of novel in vitro assay for childhood vaccines
Nyon, 29th September 2020 – The Developing Countries Vaccine Manufacturers’ Network (DCVMN), with the support of a grant awarded by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), has established an international consortium of laboratories, to advance the in-house validation of a serological potency test for whole-cell pertussis-containing childhood vaccines.

Pertussis, commonly known as whooping cough, is a severe disease caused by the Bordetella pertussis bacterium. A cornerstone of routine childhood immunization programs around the world, pertussis-containing vaccines save hundreds of thousands of lives annually.

The project, budgeted at 750 thousand USD, aims to support the in-house validation of a serological assay (Pertussis Serological Potency Test – PSPT) to replace the Kendrick Test currently used for Pertussis potency testing. The PSPT benefits from increased reliability and reproducibility, ultimately reducing the cost of a single vaccine dose while sparing countless laboratory animals from the distress implied in the current test…

 

ICBA – International Council of Biotechnology Associations [to 17 Oct 2020]
https://internationalbiotech.org/
News
No new digest content identified.

 

IFPMA [to 17 Oct 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA statement on “Intellectual Property and COVID-19”
16 October 2020
The COVID-19 pandemic has had profound health, social and economic impact around the world. The biopharmaceutical industry has made addressing the pandemic its top priority, devoting its resources, expertise, know-how, and intellectual assets to developing potential treatments, diagnostics and vaccines at unprecedented pace, while committing to and engaging in unprecedented levels of international collaboration and coordination through initiatives such as ACT-AACTIV and CEPI to ensure equitable access to products being developed.

The intellectual property (IP) system has enabled collaboration between biopharmaceutical innovators and governments, universities and other research partners to speed up progress on our most pressing unmet medical needs, including hundreds of potential COVID-19 treatments, diagnostics and vaccines for patients around the world.  It has also been the driving force behind the many innovations that will help us overcome the pandemic, giving rise to nearly all of the molecules, platforms, and other technologies that have enabled industry to target COVID-19 at an advanced stage, and helping to ensure the resources and conditions needed to see the development of promising treatments through to approval.   IP will also continue to play a crucial role long after this pandemic is over, to ensure that the world is prepared with innovative solutions for future global health crisis, in addition to other pressing healthcare needs.

Despite the critical role that IP has successfully played in enabling innovation and collaboration, some stakeholders have proposed to weaken national and international IP frameworks during the COVID-19 pandemic. While we share the objective of equitable access to medicines, we disagree with the premise that IP rights are potential barriers to R&D, public-private collaborations or access to COVID-19 products. Our experience shows the opposite. Indeed, because IP is so critical to each of the goals of innovation, collaboration and access, such proposals would undermine all of them, and therefore would fail to achieve what is so urgently needed.

One-size-fits all proposals advocating for diluting or suspending IP rights during this pandemic disregard the specific circumstances of each situation, each product and each country – all facing very different challenges regarding the manufacture and distribution of COVID-19 treatments and vaccines. The international IP system already has rules and practices to permit customized solutions to real-world problems that may arise…

Biopharmaceutical industry support EU regulators exceptional transparency measures and call other regulatory authorities to follow
Geneva, 13 October 2020: IFPMA & EFPIA support European Medicines Agency’s (EMA) initiative to implement exceptional transparency measures that are targeting regulatory activities for the assessment and approval of medicines and vaccines for COVID-19.[1] The biopharmaceutical industry represented by IFPMA and EFPIA encourage other national regulatory authorities to follow EMA’s example.

The European Medicines Agency (EMA) announced several exceptional transparency measures[2] that are targeting regulatory activities for the assessment and approval of medicines and vaccines for COVID-19.[3] These transparency measures are focused on accelerating the publication of key documents at this exceptional time, such as news announcements for rolling reviews and compassionate use opinions, as well as implementing shorter timeframes for publishing public assessment reports. The measures also include publication after marketing authorization of the complete version of the risk management plan and the clinical trial data used in support of the regulatory approval for the medicine and vaccine. Along with the implementation of the measures comes the added responsibility of providing the appropriate context around the availability of this additional data and information. It is paramount to ensure that safeguards are in place to preserve privacy of patients who volunteer in the biomedical research.

Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) says: “As an industry, we recognize that there are important public health benefits associated with making clinical trial results more widely available and hope that such measures will help to broaden confidence in the science and the decision-making that is guiding the development of medicines and vaccines for COVID-19.”

Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) are of the same view: “We believe that this initiative will better inform patients, health care professionals, researchers, media, policymakers, and the general public about ongoing regulatory processes and procedures. The EMA initiative of exceptional transparency measures will help to enhance trust and confidence in the evaluation and approval process that is critical during COVID-19.”

IFPMA applauds APEC for trailblazing efforts to demonstrate return on ethics for SMEs through Vision 2025
GENEVA, 13 October 2020: Today, IFPMA joined hundreds of diverse stakeholders from more than 30 economies spanning the Asia-Pacific and beyond in a shared commitment to solidify and grow the world’s largest public-private, multi-sectoral partnership in the advancement of business ethics in the medical device and biopharmaceutical sectors, through Vision 2025.  This roadmap builds on a decade of work in the APEC region, resulting in the adoption of codes of ethics for industry bodies representing nearly 20,000 enterprises of every size across the APEC region, including in 10 economies where they previously did not exist.

Vision 2025 acknowledges that more needs to be done in the next five years to achieve regional alignment and implementation in ethical business practices while advancing the best interest and health of patients. These efforts are also crucial to COVID-19 response and recovery.

IFPMA members are firmly behind this roadmap, launched at the 2020 APEC Business Ethics for SMEs Virtual Forum.

 

“APEC is at the forefront of driving the most essential value in our healthcare systems today, and that’s integrity,” said David Ricks, President of the IFPMA and Chairman and CEO of Eli Lilly and Company. “We make medicines that improve people’s health or sustain their life. Trust is the bedrock of the modern pharmaceutical industry. Integrity and trust in our enterprise come first in everything that we do”, he added.

 

“Integrity is the cornerstone principle for any organization that values trust. And trust is the lifeblood of healthcare and innovation. In this context we realize our essential integrity is to pioneering new treatments that save countless lives. Integrity is our ultimate tool to win the battle against COVID-19,” said Jean-Christophe Tellier, Chief Executive Officer and Chairman of the Executive Committee at UCB, incoming President of IFPMA…

 

PhRMA [to 17 Oct 2020]
http://www.phrma.org/
Selected Press Releases, Statements
No new digest content identified.

Journal Watch

Journal Watch
Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focu-s on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.
If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

The Meaning of Informed Consent: Genome Editing Clinical Trials for Sickle Cell Disease

AJOB Empirical Bioethics
Volume 11, 2020 Issue 4
https://www.tandfonline.com/toc/uabr21/current

 

Articles
The Meaning of Informed Consent: Genome Editing Clinical Trials for Sickle Cell Disease
Stacy Desine , Brittany M. Hollister , Khadijah E. Abdallah , Anitra Persaud , Sara Chandros Hull & Vence L. Bonham
Pages 195-207 | Published online: 12 Oct 2020 Open Access
https://doi.org/10.1080/23294515.2020.1818876
Abstract
Background
A first therapeutic target of somatic genome editing (SGE) is sickle cell disease (SCD), the most commonly inherited blood disorders, affecting more than 100,000 individuals in the United States. Advancement of SGE is contingent on patient participation in first in human clinical trials. However, seriously ill patients may be vulnerable to overestimating the benefits of early phase studies while underestimating the risks. Therefore, ensuring potential clinical trial participants are fully informed prior to participating in a SGE clinical trial is critical.
Methods: We conducted a mixed-methods study of adults with SCD as well as parents and physicians of individuals with SCD. Participants were asked to complete a genetic literacy survey, watch an educational video about genome editing, complete a two-part survey, and take part in focus group discussions. Focus groups addressed topics on clinical trials, ethics of gene editing, and what is not understood regarding gene editing. All focus groups were audio-recorded, transcribed, and analyzed using conventional content analysis techniques to identify major themes.
Results: Our study examined the views of SCD stakeholders regarding what they want and need to know about genome editing to make an informed decision to participate in a SGE clinical trial. Prominent themes included stakeholders’ desire to understand treatment side effects, mechanism of action of SGE, trial qualification criteria, and the impact of SGE on quality of life. In addition, some physicians expressed concerns about the extent to which their patients would understand concepts related to SGE; however, individuals with SCD demonstrated higher levels of genetic literacy than estimated by physicians.
Conclusions: Designing ethically robust genome editing clinical trials for the SCD population will require, at a minimum, addressing the expressed information needs of the community through culturally sensitive engagement, so that they can make informed decisions to consider participation in clinical trials.

Ethical, Legal, and Social Issues (ELSI) of Responsible Data Sharing Involving Children in Genomics: A Systematic Literature Review of Reasons

AJOB Empirical Bioethics
Volume 11, 2020 Issue 4
https://www.tandfonline.com/toc/uabr21/current

 

Article
Ethical, Legal, and Social Issues (ELSI) of Responsible Data Sharing Involving Children in Genomics: A Systematic Literature Review of Reasons
Vasiliki Rahimzadeh , Bartha Maria Knoppers & Gillian Bartlett
Pages: 233-245
Published online: 25 Sep 2020

Do the dynamics of vaccine programs improve the full immunization of children under the age of five in Cameroon?

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 17 Oct 2020)

 

Do the dynamics of vaccine programs improve the full immunization of children under the age of five in Cameroon?
Among the eight Millennium Development Goals (MDGs), three were devoted to health. Two amongst which MDG4 in relation to the reduction of infant mortality has not been achieved in Least Developed Countries (LD…
Authors: Rodrigue Nda’chi Deffo and Benjamin Fomba Kamga
Citation: BMC Health Services Research 2020 20:953
Content type: Research article
Published on: 15 October 2020

Vaccine-associated measles in a patient treated with natalizumab: a case report

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 17 Oct 2020)

 

Vaccine-associated measles in a patient treated with natalizumab: a case report
Safety of live vaccines in patients treated with immunosuppressive therapies is not well known, resulting in contradictory vaccination recommendations. We describe here the first case of vaccine-associated mea…
Authors: Alix Miauton, Rainer Tan, Vasiliki Pantazou, Renaud Du Pasquier and Blaise Genton
Citation: BMC Infectious Diseases 2020 20:753
Content type: Case report
Published on: 14 October 2020

Impact of the COVID-19 pandemic on the human resources for health in India and key policy areas to build a resilient health workforce

Gates Open Research
https://gatesopenresearch.org/browse/articles
[Accessed 17 Oct 2020]

 

Open Letter metrics AWAITING PEER REVIEW
Impact of the COVID-19 pandemic on the human resources for health in India and key policy areas to build a resilient health workforce [version 1; peer review: awaiting peer review]
Ankita Mukherjee, Rakesh Parashar
Peer Reviewers Invited
Funder: Bill and Melinda Gates Foundation
PUBLISHED 15 Oct 2020

Understanding the trends in international agreements on pricing and reimbursement for newly marketed medicines and their implications for access to medicines: a computational text analysis

Globalization and Health
http://www.globalizationandhealth.com/

 

Research
Understanding the trends in international agreements on pricing and reimbursement for newly marketed medicines and their implications for access to medicines: a computational text analysis
Authors: Kyung-Bok Son
14 October 2020

Effect of human papilloma virus vaccination on sexual behaviours among adolescent women in Rwanda: a regression discontinuity study

Health Policy and Planning
Volume 35, Issue 8, October 2020
https://academic.oup.com/heapol/issue/35/8

 

Original Articles
Effect of human papilloma virus vaccination on sexual behaviours among adolescent women in Rwanda: a regression discontinuity study
Celestin Hategeka, Gina Ogilvie, Marie Paul Nisingizwe, Stephen Rulisa, Michael R Law
Health Policy and Planning, Volume 35, Issue 8, October 2020, Pages 1021–1028, https://doi.org/10.1093/heapol/czaa083

Utilization of traditional medicine in primary health care in low- and middle-income countries: a systematic review

Health Policy and Planning
Volume 35, Issue 8, October 2020
https://academic.oup.com/heapol/issue/35/8

 

Reviews
Utilization of traditional medicine in primary health care in low- and middle-income countries: a systematic review
Jae Kyoun Kim, Kyeong Han Kim, Yong Cheol Shin, Bo-Hyoung Jang, Seong-Gyu Ko
Health Policy and Planning, Volume 35, Issue 8, October 2020, Pages 1070–1083, https://doi.org/10.1093/heapol/czaa022

Disability inclusion in humanitarian action

Humanitarian Exchange Magazine
Number 78, October 2020
https://odihpn.org/magazine/inclusion-of-persons-with-disabilities-in-humanitarian-action-what-now/

 

Disability inclusion in humanitarian action
by HPN October 2020
The theme of this edition of Humanitarian Exchange, co-edited with Sherin Alsheikh Ahmed from Islamic Relief Worldwide, is disability inclusion in humanitarian action. Persons with disabilities are not only disproportionately impacted by conflicts, disasters and other emergencies, but also face barriers to accessing humanitarian assistance. At the same time, global commitments and standards and the IASC Guidelines on the inclusion of persons with disabilities in humanitarian action all emphasise how persons with disabilities are also active agents of change. Disability and age-focused organisations have led on testing and demonstrating how inclusion can be done better. Yet despite this progress, challenges to effective inclusion remain.

As Kirstin Lange notes in the lead article, chief among these challenges is humanitarian agencies’ lack of engagement with organisations of persons with disabilities. Simione Bula, Elizabeth Morgan and Teresa Thomson look at disability inclusion in humanitarian response in the Pacific, and Kathy Al Jubeh and Alradi Abdalla argue for a ‘participation revolution’, building on learning from the gender movement. Tchaurea Fleury and Sulayman AbdulMumuni Ujah outline how the Bridge Article 11 training initiative is encouraging constructive exchange between humanitarian and disability actors. The lack of good, disaggregated data is highlighted by Sarah Collinson; Frances Hill, Jim Cranshaw and Carys Hughes emphasise the need for training resources in local languages and accessible formats; and Sophie Van Eetvelt and colleagues report on a review of the evidence on inclusion of people with disabilities and older people.

Rebecca Molyneux and co-authors analyse the findings of a review of a DFID programme in north-east Nigeria, while Carolin Funke highlights the importance of strategic partnerships between disability-focused organisations, drawing on her research in Cox’s Bazar. Sherin Alsheikh Ahmed describes Islamic Relief Worldwide’s approach to mainstreaming protection and inclusion, while Pauline Thivillier and Valentina Shafina outline IRC’s Client Responsive Programming. The edition ends with reflections by Mirela Turcanu and Yves Ngunzi Kahashi on CAFOD’s SADI approach.

Occupational Safety and Health Administration (OSHA) and Worker Safety During the COVID-19 Pandemic

JAMA
October 13, 2020, Vol 324, No. 14, Pages 1371-1476
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
Occupational Safety and Health Administration (OSHA) and Worker Safety During the COVID-19 Pandemic
David Michaels, PhD, MPH; Gregory R. Wagner, MD
free access
JAMA. 2020;324(14):1389-1390. doi:10.1001/jama.2020.16343
This Viewpoint discusses the importance of preventive measures and supplies to reduce workplace COVID-19 transmission and calls for the US Occupational Safety and Health Administration (OSHA) to issue an enforceable requirement that employers implement standards and plans to minimize COVID-19 incidence among essential workers and spread to their families and communities.

Suboptimal US Response to COVID-19 Despite Robust Capabilities and Resources

JAMA
October 13, 2020, Vol 324, No. 14, Pages 1371-1476
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
Suboptimal US Response to COVID-19 Despite Robust Capabilities and Resources
Jennifer B. Nuzzo, DrPH, SM; Jessica A. Bell, MS; Elizabeth E. Cameron, PhD
free access
JAMA. 2020;324(14):1391-1392. doi:10.1001/jama.2020.17395
This Viewpoint attempts to reconcile the US’s high 2019 preparedness ranking on the Global Health Security Index, an international framework for benchmarking health security, and its faltering coronavirus disease 2019 (COVID-19) pandemic response, and explores lessons learned from other countries whose higher rankings and efficient responses were more closely aligned.

The Case for Algorithmic Stewardship for Artificial Intelligence and Machine Learning Technologies

JAMA
October 13, 2020, Vol 324, No. 14, Pages 1371-1476
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
The Case for Algorithmic Stewardship for Artificial Intelligence and Machine Learning Technologies
Stephanie Eaneff, MSP; Ziad Obermeyer, MD; Atul J. Butte, MD, PhD
has audio
JAMA. 2020;324(14):1397-1398. doi:10.1001/jama.2020.9371
This Viewpoint proposes creation of algorithmic stewardship programs at health systems, tasked similar to antibiotic stewardship committees with oversight of artificial intelligence and machine learning technologies to ensure they are used safely, effectively, fairly, and to the benefit of diverse patient populations.
Conversations with Dr Bauchner: Algorithmic Stewardship for Artificial Intelligence and Machine Learning Technologies

Methodological guidance for the conduct of mixed methods systematic reviews

JBI Database of Systematic Review and Implementation Reports
October 2020 – Volume 18 – Issue 10
https://journals.lww.com/jbisrir/Pages/currenttoc.aspx

 

METHODOLOGY
Methodological guidance for the conduct of mixed methods systematic reviews
Stern, Cindy; Lizarondo, Lucylynn; Carrier, Judith; More
JBI Evidence Synthesis. 18(10):2108-2118, October 2020.

Methodologic approaches in studies using real-world data to measure pediatric safety and effectiveness of vaccines administered to pregnant women: a scoping review protocol

JBI Database of Systematic Review and Implementation Reports
October 2020 – Volume 18 – Issue 10
https://journals.lww.com/jbisrir/Pages/currenttoc.aspx

 

SYSTEMATIC REVIEW PROTOCOLS
Methodologic approaches in studies using real-world data to measure pediatric safety and effectiveness of vaccines administered to pregnant women: a scoping review protocol
Lasky, Tamar; McMahon, Ann W.; Hua, Wei; More
JBI Evidence Synthesis. 18(10):2164-2170, October 2020.

Public spending on orphan medicines: a review of the literature

Journal of Pharmaceutical Policy and Practice
https://joppp.biomedcentral.com/
[Accessed 17 Oct 2020]

 

Public spending on orphan medicines: a review of the literature
Little is known about how much public payers spend on orphan medicines. This study aimed at identifying information on orphan medicine expenditure incurred by public payers that was published in literature globally and at possibly synthesising their shares as portion of the total pharmaceutical expenditure.
Authors: Margit Gombocz and Sabine Vogler
Content type: Research
13 October 2020

Global health: time for radical change?

The Lancet
Oct 17, 2020 Volume 396 Number 10258 p1129-1306
https://www.thelancet.com/journals/lancet/issue/current

 

Editorial
Global health: time for radical change?
The Lancet
What strategies should governments adopt to improve the health of their citizens? Amid the COVID-19 syndemic it would be easy to focus attention on global health security—at a minimum, strong public health and health-care systems. WHO has based its global health strategy on three pillars: universal health coverage, health emergencies, and better health and wellbeing. The indispensable elements of robust public health and health care are well known and endlessly rehearsed—a capable health workforce; effective, safe, and high-quality service delivery; health information systems; access to essential medicines; sufficient financing; and good governance. But has the gaze of global health been too narrow? Have health leaders and advocates been missing the most important determinants of human health?

The latest report of the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 raises uncomfortable questions about the direction global health has taken in the 21st century. On the one hand, the news seems good. The health of the world’s population is steadily improving. Global life expectancy at birth increased from 67·2 years in 2000 to 73·5 years in 2019. Healthy life expectancy has increased in 202 of 204 countries and territories. In 21 countries, healthy life expectancy at birth increased by more than 10 years between 1990 and 2019, with gains of up to 19·1 years. The estimated number of deaths in children under 5 years decreased from 9·6 million in 2000 to 5 million in 2019. Indeed, the falls in rates of age-standardised disability-adjusted life-years since 1990 have been the largest for communicable, maternal, neonatal, and nutritional diseases—and progress has been fastest in the past decade.

But GBD also reveals, once again, that health depends on more than health systems. The strong correlation between health and the socio-demographic index—a summary metric of a country’s overall development based on average income per capita, educational attainment, and total fertility rates—suggests that the health sector should consider redefining its scope of concern.

GBD 2019 also offers a revised theory of the demographic transition, delineating seven separate stages. A particular innovation is the idea of late-transition and post-transition stages, disaggregated for migration status. 35 countries, largely in sub-Saharan Africa and the Middle East, are in mid-transition, with falling birth and death rates (as of 2019, no countries were in the pre-transition stage). Countries such as Brazil, China, and the USA are in the late-transition stage, with death rates plateauing, while birth rates continue to decrease. The final post-transition stage is when the birth rate is lower than the death rate and natural population growth is negative—as seen in Japan, Italy, and Russia. An important and overlooked influence on these demographic stages is migration. 17 countries, including Spain, Greece, and many eastern European countries, are in “a precarious state”—in the post-transition stage, with net emigration. Here, policies are needed to lessen the social and economic effects of an increasingly inverted population pyramid—encouraging immigration could be one way to help.
None of these arguments should suggest that universal health coverage and global health security are irrelevant to health. As the GBD 2019 authors argue, some countries have longer life expectancies than their stage of development would predict. These overperforming nations—such as Niger, Ethiopia, Portugal, and Spain—probably have superior public health and health-care policies. What GBD 2019 does suggest is that the global health community needs to radically rethink its vision. An exclusive focus on health care is a mistake. Health is created from a broader prospectus that includes the quality of education (primary to tertiary), economic growth, gender equality, and migration policy.

This conclusion is immediately relevant to national strategies to address COVID-19. Although attention should be given to controlling community transmission of severe acute respiratory syndrome coronavirus 2 and protecting those most vulnerable to its consequences, success will require a more capacious strategy. COVID-19 is a syndemic of coronavirus infection combined with an epidemic of non-communicable diseases, both interacting on a social substrate of poverty and inequality. The message of GBD is that unless deeply embedded structural inequities in society are tackled and unless a more liberal approach to immigration policies is adopted, communities will not be protected from future infectious outbreaks and population health will not achieve the gains that global health advocates seek. It’s time for the global health community to change direction.

Five insights from the Global Burden of Disease Study 2019

The Lancet
Oct 17, 2020 Volume 396 Number 10258 p1129-1306
https://www.thelancet.com/journals/lancet/issue/current

 

Viewpoint
Five insights from the Global Burden of Disease Study 2019
GBD 2019 Viewpoint Collaborators
Summary
The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 provides a rules-based synthesis of the available evidence on levels and trends in health outcomes, a diverse set of risk factors, and health system responses. GBD 2019 covered 204 countries and territories, as well as first administrative level disaggregations for 22 countries, from 1990 to 2019. Because GBD is highly standardised and comprehensive, spanning both fatal and non-fatal outcomes, and uses a mutually exclusive and collectively exhaustive list of hierarchical disease and injury causes, the study provides a powerful basis for detailed and broad insights on global health trends and emerging challenges. GBD 2019 incorporates data from 281 586 sources and provides more than 3·5 billion estimates of health outcome and health system measures of interest for global, national, and subnational policy dialogue. All GBD estimates are publicly available and adhere to the Guidelines on Accurate and Transparent Health Estimate Reporting. From this vast amount of information, five key insights that are important for health, social, and economic development strategies have been distilled. These insights are subject to the many limitations outlined in each of the component GBD capstone papers.

Global age-sex-specific fertility, mortality, healthy life expectancy (HALE), and population estimates in 204 countries and territories, 1950–2019: a comprehensive demographic analysis for the Global Burden of Disease Study 2019

The Lancet
Oct 17, 2020 Volume 396 Number 10258 p1129-1306
https://www.thelancet.com/journals/lancet/issue/current

 

Global Health Metrics
Global age-sex-specific fertility, mortality, healthy life expectancy (HALE), and population estimates in 204 countries and territories, 1950–2019: a comprehensive demographic analysis for the Global Burden of Disease Study 2019
GBD 2019 Demographics Collaborators
Open Access

Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019

The Lancet
Oct 17, 2020 Volume 396 Number 10258 p1129-1306
https://www.thelancet.com/journals/lancet/issue/current

 

Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019
GBD 2019 Diseases and Injuries Collaborators
Open Access

Global burden of 87 risk factors in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019

The Lancet
Oct 17, 2020 Volume 396 Number 10258 p1129-1306
https://www.thelancet.com/journals/lancet/issue/current

 

Global burden of 87 risk factors in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019
GBD 2019 Risk Factors Collaborators
Open Access

Measuring universal health coverage based on an index of effective coverage of health services in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019

The Lancet
Oct 17, 2020 Volume 396 Number 10258 p1129-1306
https://www.thelancet.com/journals/lancet/issue/current

 

Articles
Measuring universal health coverage based on an index of effective coverage of health services in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019
GBD 2019 Universal Health Coverage Collaborators
Open Access

Fertility, mortality, migration, and population scenarios for 195 countries and territories from 2017 to 2100: a forecasting analysis for the Global Burden of Disease Study

The Lancet
Oct 17, 2020 Volume 396 Number 10258 p1129-1306
https://www.thelancet.com/journals/lancet/issue/current

 

Fertility, mortality, migration, and population scenarios for 195 countries and territories from 2017 to 2100: a forecasting analysis for the Global Burden of Disease Study
Stein Emil Vollset, et al
Open Access

Curing COVID-19

Lancet Infectious Diseases
Oct 2020, Volume 20 Number 10 p1101-1216, e250-e283
http://www.thelancet.com/journals/laninf/issue/current

 

Editorial
Curing COVID-19
The Lancet Infectious Diseases
As the COVID-19 pandemic moves into its 10th month, greater patient survival suggests that treatment of severe disease has improved. How much of this improvement is due to better supportive care and how much to pharmaceuticals is a matter of debate. Given the huge effort that the biomedical community has put into finding drugs to treat COVID-19, with thousands of trials completed and ongoing, it’s worth taking stock of the evidence for what has worked and what has not…

Vaccinology: time to change the paradigm?

Lancet Infectious Diseases
Oct 2020, Volume 20 Number 10 p1101-1216, e250-e283
http://www.thelancet.com/journals/laninf/issue/current

 

Personal View
Vaccinology: time to change the paradigm?
Christine Stabell Benn, Ane B Fisker, Andreas Rieckmann, Signe Sørup, Peter Aaby
Summary
The existing vaccine paradigm assumes that vaccines only protect against the target infection, that effective vaccines reduce mortality corresponding to the target infection’s share of total mortality, and that the effects of vaccines are similar for males and females. However, epidemiological vaccine research has generated observations that contradict these assumptions and suggest that vaccines have important non-specific effects on overall health in populations. These include the observations that several live vaccines reduce the incidence of all-cause mortality in vaccinated compared with unvaccinated populations far more than can be explained by protection against the target infections, and that several non-live vaccines are associated with increased all-cause mortality in females. In this Personal View we describe current observations and contradictions and define six emerging principles that might explain them. First, that live vaccines enhance resistance towards unrelated infections. Second, non-live vaccines enhance the susceptibility of girls to unrelated infections. Third, the most recently administered vaccination has the strongest non-specific effects. Fourth, combinations of live and non-live vaccines given together have variable non-specific health effects. Fifth, vaccinating children with live vaccines in the presence of maternal immunity enhances beneficial non-specific effects and reduces mortality. Finally, vaccines might interact with other co-administered health interventions, for example vitamin A supplementation. The potential implications for child health are substantial. For example, if BCG vaccination was given to children at birth, if higher measles vaccination coverage could be obtained, if diphtheria, tetanus, and pertussis-containing vaccines were not given with or after measles vaccine, or if the BCG strain with the best non-specific effects could be used consistently, then child mortality could be considerably lower. Pursuing these emerging principles could improve our understanding and use of vaccines globally.