Vaccines and Global Health: The Week in Review :: 22 September 2018

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

Ebola virus disease – Democratic Republic of the Congo :: Update to 22 Sep 2018

Milestones :: Perspectives
 
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Ebola – Democratic Republic of the Congo

Ebola virus disease – Democratic Republic of the Congo
Disease outbreak news
20 September 2018
The Ebola virus disease (EVD) outbreak in the Democratic Republic of the Congo remains active. While substantial progress has been made to limit the spread of the disease to new areas and the situation in Mangina (Mabalako Health Zone) is stabilizing, the cities of Beni and Butembo have become the new hotspot. Response teams continue to enhance activities to mitigate potential clusters in these cities and prevent spread to other areas.

Significant risks for further spread of the disease remain. Continued challenges include contacts lost to follow-up, delayed recognition of EVD in health centres, poor infection prevention and control (IPC) in health centres, and reluctance among some cases to be treatment in Ebola treatment centres (ETCs). While the majority of communities have welcomed response measures, in some, risks of transmission and poor disease outcomes have been amplified by unfavourable behaviours, with reluctance to adopt prevention and risk mitigation strategies.
The priority remains strengthening all components of the public health response in all affected areas, as well as continuing to enhance operational readiness and preparedness in the non-affected provinces of the Democratic Republic of the Congo and neighbouring countries.

Since the last Disease Outbreak News (data as of 12 September), five new confirmed EVD cases were reported: four from Beni and one from Butembo health zones. All have been linked to ongoing transmission chains within these respective communities…

Public health response
…As of 19 September, 58 vaccination rings have been defined, in addition to 24 rings of health workers and other frontline workers. These rings include the contacts (and their contacts) of all confirmed cases from the last four weeks. To date, 10 701 people consented and were vaccinated, including 4008 health care or frontline workers, and 2362 children. The ring vaccination teams are currently active in three health areas in North Kivu and one in Ituri…

07: Situation report on the Ebola outbreak in North Kivu 18 September 2018

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Uganda Prepares to Vaccinate against Ebola in Case the Virus Strikes the Country
Kampala, 20th September 2018: As Ebola Virus Disease (EVD) preparedness activities intensify in Uganda, the Ministry of Health with support from the World Health Organization (WHO) is making arrangements to vaccinate frontline health workers and high-risk populations should need arise.

In case Uganda gets a case of EVD, a strategy known as ring vaccination will be implemented. Under this strategy, health workers will define several layers of contacts also known as contacts, contact of contacts and vaccinate them. These are people most likely to be infected with the virus and they usually include health workers, family members of EVD patients, their neighbours and friends.

The ring vaccination strategy was used to eradicate smallpox in the 1970s, it helped contain the EVD outbreak in West Africa and is currently being used to control the disease in Eastern Democratic Republic Congo (DRC).

“EVD is a highly contagious and deadly disease with the Ebola Zaire strain being the most virulent. Health workers often lose their lives during Ebola outbreaks. Therefore, the rollout of this life-saving vaccine will go a long way in averting health worker mortality due to exposure to the deadly disease,” said Dr. Jane Ruth Aceng, Minister of Health.

In Uganda’s preparation, spaces for the cold chain to store the vaccine have already been identified. The freezers, the transportation crates, storage boxes, pallets, and vaccines carriers have arrived in the country and have been installed. A total of 3000 doses of the rVSV-ZEBOV Ebola vaccine will be imported and administered in an estimated period of six months using the compassionate approach. This vaccine is highly protective and has demonstrated efficacy against Ebolavirus-Zaire that is currently affecting parts of DRC in North Kivu and Ituri Provinces…

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WHO and CDC support the Ministry of Health to strengthen capacity for detection, investigation and response to Ebola Virus Disease in districts bordering the Democratic Republic of Congo
17 September 2018
The outbreak of Ebola Virus Disease (EVD) in the Democratic Republic of Congo (DRC) in Beni, North Kivu province poses a risk of the disease spreading beyond the borders of the country to its neighboring countries including Zambia. It is for this reason that the WHO Country Office in collaboration with the US Centres for Disease Prevention and Control (CDC) and Africa CDC has provided financial and technical support to the Ministry of Health through the Zambia National Public Health Institute (ZNPHI) to strengthen capacity for prevention, detection, investigation and response to Ebola Virus Disease in districts bordering the DRC. Zambia is particularly at high risk of importation of cases due to the cross-border movement of people and goods. In addition, the country hosts several camps of refugees fleeing from the civil unrest in Eastern DRC and has continued to receive more refugees even during the on-going EVD outbreak…

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Press release
155 children left orphaned or separated from their parents in DRC’s latest Ebola outbreak – UNICEF
KINSHASA/DAKAR/NEW YORK/GENEVA, 21 September 2018 – UNICEF and its partners have so far identified 155 children who have been orphaned or left unaccompanied as a result of the latest Ebola outbreak in the eastern Democratic Republic of the Congo (DRC). This figure includes children who have lost one or both parents, or primary caregivers to Ebola, as well as those who have been left unaccompanied while their parents are isolated in Ebola treatment centres.

Children who lose a parent due to Ebola are at risk of being stigmatized, isolated or abandoned, in addition to the experience of losing a loved one or primary caregiver. This group of children, in addition to those who have been left on their own while their parents receive in-patient treatment, are particularly vulnerable and UNICEF is concerned for their wellbeing.

“The loss of a parent or a loved one can be a deeply upsetting experience for a child,” said Dr Gianfranco Rotigliano, UNICEF Representative in the DRC. “Our mission is to protect and to assist all the children affected by the Ebola virus. As the outbreak continues, we will continue to coordinate with our partners to ensure their physical, emotional and psychological wellbeing.”…

WHO launches first investment case to save up to 30 million lives

Milestones :: Perspectives

WHO launches first investment case to save up to 30 million lives

News Release   19 September 2018
WHO today published its first investment case, setting out the transformative impacts on global health and sustainable development that a fully-financed WHO could deliver over the next five years.

The investment case describes how WHO, working together with its Member States and partners, will help to save up to 30 million lives, add up to 100 million years of healthy living to the world’s population and add up to 4 per cent of economic growth in low and middle-income countries by 2023.

Achieving these results would require an investment of $14.1 billion from 2019 to 2023, representing a 14% increase in WHO’s base budget* over the previous five-year period. These investments would help achieve the “triple billion” targets of WHO’s General Programme of Work: 1 billion more people benefitting from universal health coverage; 1 billion more people better protected from health emergencies; and 1 billion more people enjoying better health and well-being.

“This is the first time we have estimated the results we could achieve and the impact we could deliver with the right resources,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Our investment case isn’t only about investing in an institution, it’s about investing in people, and in the healthier, safer, fairer world we all want.”

The investment case shows how a stronger, more efficient, and results-oriented WHO will serve and guide governments and partners in their efforts to improve the health of their populations. It highlights new mechanisms to measure success, ensuring a strict model of accountability, and sets ambitious targets for savings and efficiencies.

“WHO is the only international organization that enjoys universal political legitimacy on global health matters,” Angela Merkel, Chancellor of Germany, says in the investment case.

The document highlights the vital work WHO does in providing up-to-date, evidence-based health guidance to support countries in improving the health of their population.
“As it embarks on its eighth decade, the World Health Organization is as essential and central as ever,” said Paul Kagame, President of Rwanda. “It has a unique role in developing new norms and standards, and sharing life-saving tools and technologies.”

The investment case also emphasizes WHO’s focus on equity, gender and rights-based approaches that aim to close gaps in health service coverage and empower individuals and communities to ensure no one is left behind.

“WHO’s leadership is essential to placing UHC at the forefront of the global development agenda,” said Dr Jim Yong Kim, President of the World Bank Group.

The investment case outlines WHO’s critical role as a partner, convener, and driving force in coordinating efforts across the global health arena.

“We look forward to working with the World Health Organization, governments and partners around the world to build strong primary health systems as an essential step to achieving health for all,” said Bill Gates, Co-Chair of the Bill & Melinda Gates Foundation.
:: Download the full investment case
:: Background technical paper
:: WHO’s General Programme of Work

WHO – Global tuberculosis report 2018 :: WHO calls for urgent action to end TB

Milestones :: Perspectives

WHO – Global tuberculosis report 2018
September 2018 :: 243 pages   ISBN 978-92-4-156564-6
PDF: http://apps.who.int/iris/bitstream/handle/10665/274453/9789241565646-eng.pdf?ua=1
WHO has published a global TB report every year since 1997. The main aim of the report is to provide a comprehensive and up-to-date assessment of the TB epidemic, and of progress in prevention, diagnosis and treatment of the disease at global, regional and country levels. This is done in the context of recommended global TB strategies and targets endorsed by WHO’s Member States and broader development goals set by the United Nations. The data in this report are updated annually.
 
[Excerpt]
8.3 New vaccines to prevent TB  [p.159]
The bacille Calmette-Guérin (BCG) vaccine, first used in the 1920s, remains the only licensed vaccine for preventing TB. Despite high coverage of BCG vaccination as part of childhood immunization programmes (Chapter 5), the slow decline in TB incidence globally highlights the need  for a much more effective vaccine that provides protection against all forms of TB in all age groups.

The status of the pipeline for new TB vaccines in August 2018, including the names of vaccine developers, is shown in Fig. 8.3. There are 12 vaccines in Phase I, II or III trials. Their main characteristics are summarized below…
 
 
News Release
WHO calls for urgent action to end TB
Fewer people fell ill and died from tuberculosis (TB) last year but countries are still not doing enough to end TB by 2030, warns the World Health Organization (WHO).  Although global efforts have averted an estimated 54 million TB deaths since 2000, TB remains the world’s deadliest infectious disease.

WHO’s 2018 Global TB Report, released in New York today, calls for an unprecedented mobilization of national and international commitments. It urges political leaders gathering next week for the first-ever United Nations High-level Meeting on TB to take decisive action, building on recent moves by the leaders of India, the Russian Federation, Rwanda, and South Africa. Nearly 50 Heads of State and Government are expected to attend the meeting.

“We have never seen such high-level political attention and understanding of what the world needs to do to end TB and drug-resistant TB, said Dr.Tedros Adhanom Ghebreyesus, WHO Director-General.   “We must capitalize on this new momentum and act together to end this terrible disease.”

To meet the global target of ending TB by 2030, countries need to urgently accelerate their response – including by increasing domestic and international funding to fight the disease. The WHO report provides an overview of status of the epidemic and the challenges and opportunities countries face in responding to it.

Status of the TB epidemic

  • Overall, TB deaths have decreased over the past year. In 2017, there were 1.6 million deaths (including among 300 000 HIV-positive people). Since 2000, a 44% reduction in TB deaths occurred among people with HIV compared with a 29% decrease among HIV-negative people;
  • Globally, an estimated 10 million people developed TB in 2017. The number of new cases is falling by 2% per year, although faster reductions have occurred in Europe (5% per year) and Africa (4% per year) between 2013 and 2017;
  • Some countries are moving faster than others – as evidenced in Southern Africa, with annual declines (in new cases) of 4% to 8% in countries such as Lesotho, Eswatini, Namibia, South Africa, Zambia, and Zimbabwe, thanks to better TB and HIV prevention and care. In the Russian Federation, high level political commitment and intensified TB efforts have led to more rapid declines in cases (5% per year) and deaths (13% per year)
  • Drug-resistant TB remains a global public health crisis: In 2017, 558 000 people were estimated to have developed disease resistant to at least rifampicin – the most effective first-line TB drug. The vast majority of these people had multidrug-resistant TB (MDR-TB), that is, combined resistance to rifampicin and isoniazid (another key first-line TB medicine).
  • WHO estimates that a quarter of the world’s population has TB infection.


The TB response: Challenges and opportunities

      Access to care and prevention:

  • Underreporting and under-diagnosis of TB cases remains a major challenge. Of the 10 million people who fell ill with TB in 2017, only 6.4 million were officially recorded by national reporting systems, leaving 3.6 million people undiagnosed, or detected but not reported. Ten countries accounted for 80% of this gap, with India, Indonesia and Nigeria topping the list.
  • Less than half of the estimated one million children with TB were reported in 2017, making it a much higher gap in detection than that in adults.
  • Treatment coverage lags behind at 64% and must increase to at least 90% by 2025 to meet the TB targets.
  • To urgently improve detection, diagnosis and treatment rates, WHO, the Stop TB Partnership and the Global Fund launched the new initiative in 2018, Treat. All. #EndTB, which set the target of providing quality care to 40 million people with TB from 2018 to 2022.
  • Only around half of the estimated 920,000 people with HIV-associated TB were reported in 2017.Of these, 84% were on antiretroviral therapy. Most of the gaps in detection and treatment were in the WHO African Region, where the burden of HIV-associated TB is highest. Only one in four people with MDR-TB were reported to have received treatment with a second-line regimen. China and India alone were home to 40% of patients requiring treatment for MDR-TB, but not reported to be receiving it. Globally, MDR-TB treatment success remains low at 55%, often due to drug toxicity making it impossible for patients to stay on treatment. A month ago, WHO issued a Rapid Communication on key changes to treatment of drug-resistant TB based on the latest scientific evidence. These changes should result in better treatment outcomes and more lives saved. WHO is already working with countries and partners to roll out these changes.
  • The Organization predicts that at least 30 million people should be able to access TB preventive treatment between 2018 and 2022, based on new WHO guidance. Although preventive treatment for latent TB infection is expanding, most people needing it are not yet accessing care. WHO strongly recommends preventive treatment for people living with HIV, and children under 5 years living in households with TB. Related new guidance was issued by WHO in 2018, to facilitate greater access to preventive services for those who need it.
    Financing for implementation and research
  • One of the most urgent challenges is to scale up funding. In 2018, investments in TB prevention and care in low- and middle-income countries fell US$3.5 billion short of what is needed. The report flags that without an increase in funding, the annual gap will widen to US$ 5.4 billion in 2020 and to at least US$ 6.1 billion in 2022.A further US$ 1.3 billion per year is required to accelerate the development of new vaccines, diagnostics and medicines.

 
 

Gates Foundation Report Says Demographic Trends Threaten Global Progress, Calls for Increased Focus on Health and Education in Poorest Countries

Milestones :: Perspectives

Gates Foundation Report Says Demographic Trends Threaten Global Progress, Calls for Increased Focus on Health and Education in Poorest Countries
Bill and Melinda Gates say investing in young people could unlock productivity and innovation
SEATTLE, Sept. 18, 2018 /PRNewswire/ — The Bill & Melinda Gates Foundation today launched its second annual Goalkeepers Data Report, pointing to demographic trends that could stall unprecedented progress in reducing global poverty. While 1 billion people have lifted themselves out of poverty over the past 20 years, rapid population growth in the poorest countries, particularly in Africa, puts future progress at risk. If current trends continue, the number of extremely poor people in the world could stop its two-decade decline—and could even rise.

Despite the sobering projections, Bill and Melinda Gates express optimism that today’s growing youth populations could help drive progress. Investing in the health and education of young people in Africa could unlock productivity and innovation, leading to a “third wave” of poverty reduction, which follows the first wave in China and the second in India.

“The conclusion is clear: To continue improving the human condition, our task now is to help create opportunities in Africa’s fastest-growing, poorest countries,” Bill and Melinda Gates write in the introduction. “This means investing in young people. Specifically, it means investing in their health and education.”

Goalkeepers: The Stories Behind the Data 2018 was co-authored and edited by Bill and Melinda Gates and produced in partnership with the Institute for Health Metrics and Evaluation (IHME) at the University of Washington. Using new data projections, the report reveals that poverty within Africa is concentrating in just a handful of countries, which are among the fastest-growing in the world. By 2050, more than 40 percent of the extremely poor people in the world will live in just two countries: Democratic Republic of the Congo and Nigeria.

In the past, large youth populations have helped drive economic growth and poverty reduction. The report makes the case for leaders to invest in the power and potential of youth to continue progress. Through essays by experts and journalists, the report examines promising approaches in health and education, highlighting ways that young people could help transform the continent. According to the report, investments in health and education, or “human capital,” in sub-Saharan Africa could increase GDP in the region by more than 90 percent by 2050.

Each year, the report tracks 18 data points from the UN Sustainable Development Goals, or Global Goals, including child and maternal deaths, stunting, access to contraceptives, HIV, malaria, extreme poverty, financial inclusion, and sanitation. IHME projections provide three potential scenarios for indicators: better and worse scenarios based upon accelerating or reducing the rate of progress, and projections based upon current trends. This year’s report examines four topics in greater depth…

UCL Biochemical Engineering to lead Hub driving vaccine discovery, development and manufacturing revolution

Milestones :: Perspectives

UCL Biochemical Engineering to lead Hub driving vaccine discovery, development and manufacturing revolution
20 September 2018
Vax-Hub, a new Future Vaccine Manufacturing Research Hub, will bring together academia, industry and policy makers to affect radical change in the development and manufacturing of vaccines and improve responses to outbreaks of deadly pandemics such as Swine Flu and Ebola.

Led by UCL and the University of Oxford, Vax-Hub will look to establish the UK as a global centre for vaccine discovery, development and manufacture, while also ensuring that new vaccine manufacturing processes can be used in low and middle income countries.

The multidisciplinary team assembled at the Hub will work to address five major challenges facing vaccine manufacturing and deployment:
:: The time new vaccines take to progress to market
:: Guaranteeing long lasting supply, especially of older, legacy vaccines
:: Reducing the risk of failure in moving between different vaccine types, scales of manufacture and locations
:: Mitigating costs
: And responding to threats and future epidemics and pandemics

In addition the tools and technologies developed by the researchers, who have decades of cumulative experience in all aspects of vaccine design and manufacturing research, will be applicable for medical products intended for the UK.
The Hub has been awarded almost £7 million of UK Aid funding from the Department of Health and Social Care, which will be managed by the Engineering and Physical Sciences Research Council (EPSRC).
It will bring together 25 partners, including:
:: Public Health England
:: The University of Leeds
:: Imperial College London
:: The London School of Hygiene and Tropical Medicine
:: AstraZeneca
:: Pfizer
:: GE (General Electric Company)…
 

 

[U.S.] National Biodefense Strategy: Protect the Nation Against all Biological Threats :: National Biodefense Strategy

Milestones :: Perspectives

[U.S.] National Biodefense Strategy: Protect the Nation Against all Biological Threats
September 18, 2018
By: Robert P. Kadlec, MD, MTM&H, MS, HHS Assistant Secretary for Preparedness and Response
Summary: 
As a nation, public and private partners must work closely together to plan adaptively for current and emerging biothreats.
 
Today, the White House and four federal departments unveiled a comprehensive National Biodefense Strategy to make America safer against modern biological threats to the United States. In the 21st century, biological threats are increasingly complex and dangerous, and that demands that we act with urgency and singular effort to save lives and protect Americans.

Whether a natural outbreak, an accidental release, or a deliberate attack, biological threats are among the most serious we face, with the potential for significant health, economic and national security impacts.  Therefore, promoting our health security is a national security imperative.

The strategy released today not only establishes the U.S. government vision for biodefense, it prioritizes and coordinates federal biodefense activities and budgets. In meeting the aggressive demands of the National Biodefense Strategy – PDF as directed by President Trump’s National Security Presidential Memorandum, we will improve the nation’s readiness and response capabilities to combat 21st century biological threats to humans, animals, agriculture and the environment.

Combating 21st century biothreats requires a whole-of-nation approach
Biodefense entails a range of coordinated actions to counter biothreats, reduce risks, and prepare for, respond to, and recover from incidents. As biothreats continue to evolve, so must our biodefense capabilities.

Coordination of such complex actions requires a sound strategy, commitment, and governance structure. As an initial step in implementing the strategy, leaders from every federal department involved in biodefense formed a steering committee, led by Secretary Azar, that provides strategic guidance in preparing for, countering, and responding to biological threats. I am honored that Secretary Azar asked me to lead the day-to-day coordination team that supports this committee in improving biodefense readiness. As the assistant secretary for preparedness and response, my office routinely coordinates federal preparedness, response and recovery efforts to address the healthcare and public health impacts of public health emergencies and other disasters, including bioincidents.

The National Biodefense Strategy’s coordination team also will engage state, local, tribal and territorial governments, as well as private and international partners as appropriate, because while coordinating federal activities and budgets across the full spectrum of biodefense sectors and activities represents a monumental step forward; being truly successful will require a whole-of-nation approach with government agencies at all levels and non-government stakeholders playing important roles in providing support and guidance. As a nation, public and private partners must work closely together to plan adaptively for current and emerging biothreats, whether they stem from terrorist groups, pandemics, natural disasters, or even rouge nation states.

Seventeen years ago today, our nation experienced a biological attack with anthrax mailed in letters, killing five people and injuring 17, and costing an estimated $6 billion in clean up and lost revenue. Those historic attacks, the more recent Ebola outbreaks and the emergence of potentially deadly influenza viruses demonstrate how severe biological threats continue to evolve, both man-made and from nature, can be. By meeting the call to action in the National Biodefense Strategy, we become better equipped to protect this nation against all biothreats.

National Biodefense Strategy [U.S.]
U.S. Department of Health & Human Services
2018 :: 36 pages
FOREWORD
It is a vital interest of the United States to manage the risk of biological incidents. In today’s interconnected world, biological incidents have the potential to cost thousands of American lives, cause significant anxiety, and greatly impact travel and trade.

Biological threats—whether naturally occurring, accidental, or deliberate in origin—are among the most serious threats facing the United States and the international community. Outbreaks of disease can cause catastrophic harm to the United States. They can cause death, sicken, and disable on a massive scale, and they can also inflict psychological trauma and economic and social disruption. Natural or accidental outbreaks, as well as deliberate attacks, can originate in one country and spread to many others, with potentially far-reaching international consequences. Advances in science promise better and faster cures, economic advances, a cleaner environment, and improved quality of life, but they also bring new security risks. In this rapidly changing landscape, the United States must be prepared to manage the risks posed by natural outbreaks of disease, accidents with high consequence pathogens, or adversaries who wish to do harm with biological agents.

Health security means taking care of the American people in the face of biological threats to our homeland and to our interests abroad. The significant infectious disease outbreaks of recent decades, including Severe Acute Respiratory Syndrome (SARS), pandemic influenza, Ebola virus disease, and Zika virus disease, have revealed the extent to which individual countries and international communities need to improve their preparedness and biosurveillance systems to detect and respond to the next health crisis. The health of the American people depends on our ability to stem infectious disease outbreaks at their source, wherever and however they occur. America’s biodefense enterprise needs to be nimble enough to address emerging infectious disease threats, the risks associated with the accelerating pace of biotechnology, and threats posed by terrorist groups or adversaries seeking to use biological weapons.

The National Biodefense Strategy is aligned with the 2018 National Security Strategy of the United States. Pillar One of the 2018 National Security Strategy explicitly calls for protecting “the American people, the homeland, and the American way of life.” One component of this goal is achieved by detecting and containing biothreats at their source, supporting and promoting the responsible conduct of biomedical innovation, and improving emergency response. Pillar Two calls for “promot[ing] American prosperity,” which increasingly will depend on a vibrant life sciences and biotechnology enterprise.

This National Biodefense Strategy highlights the President’s commitment to protect the American people and our way of life, laying out a clear pathway and set of objectives to effectively counter threats from naturally occurring, accidental, and deliberate biological events. It is broader than a Federal Government strategy. It is a call to action for state, local, territorial, and tribal (SLTT) entities, other governments, practitioners, physicians, scientists, educators, and industry.

[Excerpts from Goals summary which reference vaccines; Editor’s selection and text bolding]
[p.12] GOAL 2: ENSURE BIODEFENSE ENTERPRISE CAPABILITIES TO PREVENT BIOINCIDENTS.
2.1 Promote measures to prevent or reduce the spread of naturally occurring infectious diseases.
2.1.1 Strengthen Infection Prevention Measures Domestically and Internationally.
::  Using a multidisciplinary approach, strengthen medical, public health, animal health, and plant health capacities to improve infection prevention and control.
::  Strengthen vaccination and other health intervention activities.

2.1.2 Reduce the Emergence and Spread of Antimicrobial-resistant Pathogens Domestically and Internationally.
::  Strengthen awareness of drug-resistant pathogens and their associated diseases, and improve stewardship of medically important drugs.
::  Strengthen understanding of the drivers of drug resistance and improve the development and adoption of effective mitigation measures.
::  Promote the use of preventive and therapeutic options other than antimicrobial drugs.
::  Accelerate basic and applied research and development of new antimicrobials, novel preventatives and therapeutics, vaccines, and diagnostic tests.

[p.22] GOAL 4: RAPIDLY RESPOND TO LIMIT THE IMPACTS OF BIOINCIDENTS.
4.2 Conduct federal response operations and activities in coordination with relevant non-federal actors to contain, control, and to rapidly mitigate impacts of biothreats or bioincidents.

4.2.2 Deploy MCMs and Implement CMMs.
:: Rapidly identify potentially exposed populations to begin triage, preventive healthcare activities, and treatment.
::  Ensure that access and functional needs of at-risk individuals are integrated into rapid deployment.
::  Implement CMMs and other multidisciplinary bioincident control measures, to include addressing service animal and wildlife concerns, animal vaccination, and agricultural depopulation.

4.2.3 Conduct Real-time Research.
::  Conduct real-time research during response to characterize emerging biothreat agents and develop response tools in order to improve response and recovery capacity, capability, and future preparedness.
::  Rapidly identify and disseminate guidelines and clinical approaches during a bioincident for the purpose of decreasing transmission, morbidity, and mortality; and rapidly identify and disseminate analogous approaches for animals and plants.
::  Conduct real-time clinical research to evaluate promising investigational MCMs, and identify potential novel diagnostics, treatments, and vaccines.

Minutes to midnight: Turning back the Doomsday Clock through neglected disease vaccine diplomacy

Milestones :: Perspectives

Editorial
Minutes to midnight: Turning back the Doomsday Clock through neglected disease vaccine diplomacy
Peter J. Hotez
| published 20 Sep 2018 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0006676

New information reveals that the 10 nations currently producing nuclear weapons also suffer with approximately one-half of the world’s disease burden from several neglected diseases, including intestinal helminth infections, dengue, and measles.

In the aftermath of World War II and the bombings of Hiroshima and Nagasaki, the Science and Security Board of the Bulletin of the Atomic Scientists established the Doomsday Clock, meant to symbolize the time we have left until global nuclear annihilation strikes at midnight [1]. As of 2018, we have reached two minutes until midnight, the closest we have ever gotten since 1953 when the United States detonated its first hydrogen bomb [1].

Today, the Arms Control Association identifies nine nations—United States, United Kingdom, France, Israel, Pakistan, India, Russia, China, and North Korea—hosting nuclear warhead inventories [2] (Fig 1). Together, these countries account for almost 15,000 nuclear warheads. In addition, while Iran cannot be considered yet to be a nuclear weapons nation, according to the Nuclear Threat Initiative (NTI), it has an advanced nuclear program, including substantial uranium enrichment capabilities [3].

The 10 current nuclear nations also stand out because they are simultaneously affected by neglected diseases. Shown in Table 1 is an assessment of five neglected diseases, including four neglected tropical diseases (NTDs), among the 10 countries, as determined by the Global Burden of Disease Study (GBD) 2016 [4]. It finds that the nuclear weapons states account for more than one-half of the world’s incident measles and dengue cases as well as more than 40% of the global prevalence of intestinal helminth infections (i.e., ascariasis, trichuriasis, and hookworm infection) [4]. GBD 2016 further finds that the 10 nations together also account for a significant percentage of the global incidence of cutaneous leishmaniasis and cystic echinococcosis and likely other NTDs [4].

So why should we care? In a previous assessment conducted in 2010, I estimated that the research and development (R&D) dollars spent on neglected diseases among the nuclear weapons countries amounted to less than 1/10,000th of the R&D funding spent to develop and maintain nuclear weapons technologies [5]. Since then, there has been only modest public health gains in terms of the reduction in the prevalence or incidence of these diseases, although measles incidence has been declining globally since the Millennium Development Goals.

As we move closer to midnight on the Doomsday Clock, the leaders of the 10 nuclear nations, which include at least six group of 20 (G20) nations where NTDs are surprisingly widespread [6], must recognize that funding and scientific activities currently focused on nuclear weapons could be redirected towards health expenditures. In so doing, the 10 nations would help to advance Sustainable Development Goals. As in 2010, I once again argue that neglected diseases are wise investments, both in the areas of implementation science and R&D.

There is little doubt that if the scientific leadership of the 10 nuclear nations were allowed to redirect their energies toward vaccine diplomacy [7], either by expanding coverage of existing vaccines and other interventions or by binational or multinational development of new vaccines and other technologies, we might see the elimination of the five diseases highlighted here. Recently, I emphasized the importance of binational cooperation between the two largest nuclear weapons nations, the US and Russia [8]. This approach led to the global elimination of smallpox, and soon polio, but it could be extended to neglected diseases [8]. Moreover, the US and Russia (as well as other nuclear nations) have troops deployed to NTD-endemic areas of the Middle East and elsewhere.

We’ve come a long way towards reducing the global prevalence and incidence of several NTDs [9]. Through vaccine diplomacy, we now have the opportunity of accelerating neglected disease elimination. In parallel, we might successfully set back the Doomsday Clock for at least a few minutes!
[Citations available at title link above]

Emergencies

Emergencies

 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 18 September 2018 [GPEI]
:: Featured on www.polioeradication.org: Coffee with Polio Experts – Darcy Levison of WHO talks about the logistical challenges of reaching every child in the Lake Chad subregion.

Summary of new viruses this week:
Afghanistan – one new case of wild poliovirus (WPV1)
Democratic Republic of Congo – two new cases of circulating vaccine-derived poliovirus type 2 (cVDPV2).
 
::::::
::::::
 
Editor’s Note:
WHO has posted a refreshed emergencies page which presents an updated listing of Grade 3,2,1 emergencies as below.

WHO Grade 3 Emergencies  [to 22 Sep 2018]
Bangladesh – Rohingya crisis
:: Using local materials to build health facilities  12 September 2018
:: Weekly Situation Report 43 – 13 September 2018pdf, 220kb
 KEY HIGHLIGHTS
:: Bangladesh is experiencing seasonal influenza, which may also be circulating in the camp area.
:: A total of 1,988 family and 70 co,munity water filters have so far been distributed to 13 partner organizations with the main beneficiaries being pregnant women.
:: Since February 2018, 18 327 children of 0-23 months have received BCG vaccination while the Pentavalent vaccine has been administered to 20,522 children.

Democratic Republic of the Congo
:: 07: Situation report on the Ebola outbreak in North Kivu 18 September 2018

Syrian Arab Republic
:: WHO airlifts 21 tons of medical supplies to Al-Hasakeh governorate in north-east Syria
14 September 2018

Yemen
:: Dialysis patients in Yemen struggle to obtain regular sessions amid war  16 September 2018

Iraq – No new announcements identified
Nigeria – No new announcements identified
Somalia – No new announcements identified
South Sudan – No new announcements identified

::::::
 
WHO Grade 2 Emergencies  [to 22 Sep 2018]
Cameroon  – No new announcements identified
Central African Republic  – No new announcements identified
Hurricane Irma and Maria in the Caribbean – No new announcements identified
occupied Palestinian territory – No new announcements identified
Libya – No new announcements identified
Myanmar – No new announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new announcements identified
South Africa Listeriosis (2017) – See below
Sudan – No new announcements identified
Ukraine – No new announcements identified

Outbreaks and Emergencies Bulletin, Week 37: 8 – 14 September 2018
The WHO Health Emergencies Programme is currently monitoring 52 events in the AFRO region. This week’s edition covers key ongoing events, including:
:: Ebola virus disease outbreak in the Democratic Republic of the Congo
:: Cholera outbreak in Zimbabwe
:: Cholera outbreak in Algeria
:: Yellow fever outbreak in Republic of Congo
:: Humanitarian crisis in Mali.

::::::
 
WHO Grade 1 Emergencies  [to 22 Sep 2018]
Afghanistan
Angola (in Portuguese)
Chad
Ethiopia
Kenya
Lao People’s Democratic Republic
Mali
Papua New Guinea
Peru
Tanzania
Tropical Cyclone Gira
Zambia
 
::::::
 
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. 
Yemen 
:: Yemen Humanitarian Update Covering 7–17 September 2018 | Issue 27  Published on 17 Sep 2018

Syrian Arab Republic   No new announcements identified.

::::::

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.
Ethiopia 
:: Ethiopia Humanitarian Bulletin Issue 63 | 3 – 16 September 2018
 
Somalia   No new announcements identified.

::::::
::::::
 
Editor’s Note:
We will cluster these recent emergencies as below and continue to monitor the WHO webpages for updates and key developments.

EBOLA/EVD  [to 22 Sep 2018]
http://www.who.int/ebola/en/
[See Milestones above for more detail]

MERS-CoV [to 22 Sep 2018]
http://who.int/emergencies/mers cov/en/
18 September 2018
Epicurve of confirmed global cases of MERS-CoV png, 229kb

Yellow Fever  [to 22 Sep 2018]
http://www.who.int/csr/disease/yellowfev/en/
No new announcements identified.

Zika virus  [to 22 Sep 2018]
http://www.who.int/csr/disease/zika/en/
No new announcements identified.
 

WHO & Regional Offices [to 22 Sep 2018]

WHO & Regional Offices [to 22 Sep 2018]

19 September 2018
WHO launches first investment case to save up to 30 million lives
News Release
[See Milestones above for more detail]

18 September 2018
WHO calls for urgent action to end TB
News Release
[See Milestones above for more detail]

::::::
 
Weekly Epidemiological Record, 21 September 2018, vol. 93, 38 (pp. 489–500)
:: Cholera, 2017
:: 497 Performance of acute flaccid paralysis (AFP) surveillance and incidence of poliomyelitis, 2018

::::::
 
WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
Selected Featured News
:: Countries from IGAD team up to end polio: The three Ministers of Health jointly launch to vaccinate about six million under five children.  22 September 2018
:: Uganda Prepares to Vaccinate against Ebola in Case the Virus Strikes the Country
20 September 2018
:: Botswana Leads the Way on Fighting Health Threat Endangering Millions of Lives in Africa
19 September 2018
   Botswana’s leaders made a call for urgent action on Noncommunicable
:: WHO and CDC support the Ministry of Health to strengthen capacity for detection, investigation and response to Ebola Virus Disease in districts bordering the Democratic Republic of Congo  17 September 2018

WHO Region of the Americas PAHO
:: PAHO and IACHR call on countries to guarantee people with Alzheimer’s access to health services (09/21/2018)
:: Ministries of Health from the Americas meet at PAHO to discuss health priorities in the Region (09/20/2018)
 
WHO South-East Asia Region SEARO
No new digest content identified.
 
WHO European Region EURO
:: Day 4 highlights: countries at the centre of health work 20-09-2018
:: European Region on track to ending violence against children, but greater commitment and more action still needed 20-09-2018
:: Day 3 highlights: Strategy on the health and well-being of men in the WHO European Region adopted 19-09-2018
:: Day 2 highlights: strengthening health systems to advance the 2030 Agenda for Sustainable Development 18-09-2018
:: New WHO progress report reveals the major health challenges currently facing children and adolescents in Europe 18-09-2018
:: Day 1 highlights: RC68 opens 17-09-2018

WHO Eastern Mediterranean Region EMRO
:: Dialysis patients in Yemen struggle to obtain regular sessions amid war  16 September 2018

WHO Western Pacific Region
:: WHO working closely with Republic of Korea on response to MERS case  17 September 2018

 

CDC/ACIP [to 22 Sep 2018]

CDC/ACIP [to 22 Sep 2018]

http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Thursday, September 20, 2018
U.S. Challenges World to Intensify Global Fight against Antibiotic Resistance
During the United Nations (UN) General Assembly, U.S. Department of Health and Human Services (HHS) Secretary, Alex Azar, will call on leaders worldwide to commit to an unprecedented global initiative led by HHS and the Centers for Disease Control and Prevention: The AMR Challenge.
A pledge to this initiative means escalating government, civil society, and private industry efforts to save lives from antibiotic resistance—one of the world’s greatest public health threats—by developing new vaccines and drugs, and improving use of and access to current antibiotics; by improving infection prevention and control; by reducing antibiotic resistance in the environment, like water and soil; and by sharing data to stay ahead of antibiotic-resistant germs.
The launch event is co-hosted by CDC and HHS, the Bill & Melinda Gates Foundation, CDC Foundation, Pew Charitable Trusts, the UN Foundation, and the Wellcome Trust… [Tuesday, Sept. 25, at 6 p.m. ET]

MMWR News Synopsis for September 20, 2018
Age-Associated Trends in HIV Diagnosis and Prevalence Among Men Who Have Sex with Men —United States, 2016
To avert the most infections and improve health outcomes, sexually active men who have sex with men should receive an HIV test at least once a year. If positive, they should be linked to and retained in HIV medical care to achieve viral suppression. Those testing negative should be provided HIV prevention services, including pre-exposure prophylaxis (PrEP). Sexual HIV risk changes through the lifespan. CDC analyzed national data on HIV diagnoses among gay and bisexual males by age group. Among gay and bisexual males with HIV diagnosed during 2008-2016:

Ebola control in Butembo: Africa CDC supports the local Coordination Prevention Commission

Africa CDC   [to 22 Sep 2018]

https://au.int/en/africacdc
September 20, 2018
Ebola control in Butembo: Africa CDC supports the local Coordination Prevention Commission
Butembo, DRC 20 September 2018- In order to support the Congolese Government’s efforts in the response to this tenth Ebola epidemic, the African Union, through the Africa Centers for Disease Control and Prevention (Africa CDC), is contributing to this effort by providing professionals with proven skills who are actively involved in the control and eradication of the Ebola Virus Disease in Butembo city.
These professionals include experts in infection prevention and control, who are members of the Prevention Commission of the Ebola Control Coordination of the city of Butembo…

 

 

Announcements

Announcements

 
AERAS  [to 22 Sep 2018]
http://www.aeras.org/pressreleases
No new digest content identified.
 
 
BMGF – Gates Foundation  [to 22 Sep 2018]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute    [to 22 Sep 2018]
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
No new digest content identified.

 

CARB-X   [to 22 Sep 2018]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
09.20.2018  |
CARB-X 2017-18 Annual Report is now online
CARB-X’s second year was highlighted by a growing pipeline, global partnership and exciting science in the fight against superbugs

 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 22 Sep 2018]
http://cepi.net/
No new digest content identified.

 

EDCTP    [to 22 Sep 2018]
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
No new digest content identified.

 

Emory Vaccine Center    [to 22 Sep 2018]
http://www.vaccines.emory.edu/
No new digest content identified.

 

European Medicines Agency  [to 22 Sep 2018]
http://www.ema.europa.eu/ema/
21/09/2018
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018
CHMP elects new chair and recommends thirteen medicines for approval …
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) elected Harald Enzmann as its new chair at its September 2018 meeting, for a three-year mandate starting on 21 September.
This week’s meeting of the CHMP was the last plenary meeting chaired by Dr Tomas Salmonson, who retires as chair after serving for two three-year mandates, the maximum allowed by the legislation. Dr Salmonson is a senior scientific advisor at the Swedish Medical Products Agency, where he has worked since 1986. He has been a member of the CHMP for more than 18 years and has served as chair of the Committee since September 2012…

 
European Vaccine Initiative  [to 22 Sep 2018]
http://www.euvaccine.eu/news-events
No new digest content identified.
 
 
FDA [to 22 Sep 2018]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
No new digest content identified.
 
 
Fondation Merieux  [to 22 Sep 2018]
http://www.fondation-merieux.org/
Mérieux Foundation event
Global challenges in vaccine acceptance science and programs
September 24 – 26, 2018 – Les Pensieres Center for Global Health, Veyrier du Lac (France)
 
 
Gavi [to 22 Sep 2018]
http://www.gavi.org/library/news/press-releases/
No new digest content identified.
 
 
GHIT Fund   [to 22 Sep 2018]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical
No new digest content identified.

 

Global Fund [to 22 Sep 2018]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
More Urgency, New Funding Needed to End TB
19 September 2018
The new WHO Global Tuberculosis Report 2018 is a call to arms for the international community, coming one week before the first UN High Level Meeting on TB, the Global Fund said. Of all the world’s infectious diseases, TB is the leading killer. Approximately 10 million people fell ill with the disease in 2017, and 1.6 million of those died.

 

Hilleman Laboratories   [to 22 Sep 2018]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 22 Sep 2018]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
 
 
IAVI  [to 22 Sep 2018]
https://www.iavi.org/
No new digest content identified.

 
IFFIm
http://www.iffim.org/library/news/press-releases/
No new digest content identified.

 

IVAC  [to 22 Sep 2018]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
No new digest content identified.
 
 
IVI   [to 22 Sep 2018]
http://www.ivi.int/
No new digest content identified.
 
 
JEE Alliance  [to 22 Sep 2018]
https://www.jeealliance.org/
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 22 Sep 2018]
http://www.msf.org/
Selected Press Releases/Statements
Kala azar
Diagnosing, treating and researching HIV-kala azar co-infecti…
Project Update 20 Sep 2018

Snakebite
Time to strike back at snakebite and end the antivenom acc…
Report 19 Sep 2018

Central African Republic
“We simply can’t let these people down. But we remain vigil…
Interview 18 Sep 2018

Greece
Moria is in a state of emergency
Open Letter 17 Sep 2018

Greece
Self-harm and attempted suicides increasing for child …[Lesbos]
Press Release 17 Sep 2018

 
NIH  [to 22 Sep 2018]
http://www.nih.gov/news-events/news-releases
September 20, 2018
NIH launches study to test combination antibody treatment for HIV infection
September 20, 2018 — Clinical trial will evaluate whether treatment is safe for people living with HIV.

NIH funds study to prevent, treat HIV among adolescents in poor countries
September 19, 2018 — Study seeks to identify high-risk youth and get them into medical care.

Experimental nasal influenza vaccine tested in kids, teens
September 17, 2018 — NIH-supported Phase 1 trial of potential broadly protective vaccine.

Gene variations linked to severity of Zika-related birth defects, small NIH study suggests
September 17, 2018 — Highly affected children were likely to have a mother with natural variations in genes for a key enzyme.

 

PATH  [to 22 Sep 2018]
https://www.path.org/media-center/
No new digest content identified.

 

Sabin Vaccine Institute  [to 22 Sep 2018]
http://www.sabin.org/updates/pressreleases
No new digest content identified.
 
 
UNAIDS [to 22 Sep 2018]
http://www.unaids.org/en
News
19 September 2018
National human rights institutions in eastern and southern Africa emphasize the right to health

17 September 2018
World AIDS Day 2018 theme encourages everyone to know their HIV status

 

UNICEF  [to 22 Sep 2018]
https://www.unicef.org/media/press-releases
Selected Press Releases/Reports/Statements
Statement
More violence in Yemen’s Hodeidah will push children further into the abyss
Statement from UNICEF Executive Director Henrietta Fore
21/09/2018

Press release
Refugee and migrant children arriving on Greek Islands up by one-third in 2018 – UNICEF
21/09/2018

Press release
155 children left orphaned or separated from their parents in DRC’s latest Ebola outbreak – UNICEF
21/09/2018

Press release
A child under 15 dies every five seconds around the world – UN report
Children from the highest mortality countries are up to 60 times more likely to die in the first five years of life than those from the lowest mortality countries, report also says.
18/09/2018

 

Vaccine Confidence Project  [to 22 Sep 2018]
http://www.vaccineconfidence.org/
Confidence Commentary:
Fight the infectious disease in the air — ‘fake news’
Heidi Larson | 20 Sep, 2018
Thanks to Naveen Thacker for this timely commentary:
I have been a paediatrician for over three decades and have had parents come to me with many questions about their children’s health. But over the last year I have seen a new agent cause concern in parents’ minds — one that can be dangerous, even fatal…
 

Vaccine Education Center – Children’s Hospital of Philadelphia  [to 22 Sep 2018]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
 
 
Wellcome Trust  [to 22 Sep 2018]
https://wellcome.ac.uk/news
No new digest content identified.
 
 
The Wistar Institute   [to 22 Sep 2018]
https://www.wistar.org/news/press-releases
No new digest content identified.

 

World Organisation for Animal Health (OIE)   [to 22 Sep 2018]
http://www.oie.int/en/for-the-media/press-releases/2018/
20/09/18
Investing in biosecurity: a key step to curb the spread of animal diseases
Animal diseases, such as avian influenza or African swine fever, know no borders and can continually affect new areas. Reducing the risk is possible through the implementation of procedures designed to avoid the introduction and spread of pathogens in animal populations. Veterinary Services in collaboration with the numerous stakeholders working with animals have a key role in ensuring that appropriate biosecurity measures are in place. A recent survey conducted among OIE Members of the Europe Region shows the current challenges faced in this regard.

::::::
 
BIO    [to 22 Sep 2018]
https://www.bio.org/insights/press-release
Sep 19 2018
BIO Applauds Release of New National Biodefense Strategy
“I applaud the Administration for recognizing the importance of strengthening our national biodefense and preparedness efforts. Our nation continues to face a wide range of biological threats, and this strategy is an important step in the right direction,” Tom DiLenge, BIO  President of Advocacy, Law & Public Policy.
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 22 Sep 2018]
http://www.dcvmn.org/
No new digest content identified.
 
IFPMA   [to 22 Sep 2018]
http://www.ifpma.org/resources/news-releases/
19 September 2018
Ghana plays host to major African healthcare business integrity and ethics forum
   Over a hundred Pharma industry management and healthcare professionals, medical and scientific advisors receive training on how to implement compliance programs.
   The African Stakeholder Forum will discuss progress across Africa in raising the standards in the ethics and business integrity space.
   Part of the Forum is a session to raise awareness about the impact of fake medicines in eroding trust in the governments, healthcare professionals, patients and manufacturers.
Accra, Ghana – 18-19 September 2018 – The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) holds two-day business ethics and integrity event combining training, discussion forum and awareness raising with aim to increase the level of ethical conduct. It is broadly acknowledged that an efficient healthcare system depends on mutual trust between manufacturers of medicines and vaccines, governments and health authorities, healthcare professionals and patients. The challenge is frequently to apply business ethics and integrity into the day to day reality of the healthcare community. IFPMA is organizing the “Business Integrity Days” as part of its mission to support efforts worldwide to uphold ethical standards…

PhRMA    [to 22 Sep 2018]
http://www.phrma.org/press-room
No new digest content identified.

Industry Watch     [to 22 Sep 2018]
:: Pfizer Granted FDA Breakthrough Therapy Designation for 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older
Breakthrough Therapy Designation Designed by FDA to Expedite the Development and Review of Drugs and Vaccines Which May Demonstrate Substantial Improvement Over Available Therapy1
September 20, 2018 08:00 AM Eastern Daylight Time
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older.2 Pfizer expects to start Phase 3 trials in a few months.
“There continues to be a global health need to protect against the potentially devastating effects of invasive pneumococcal disease and pneumonia caused by additional serotypes, and we are dedicated to continue to build on our expertise in pneumococcal conjugate vaccines with this vaccine candidate.”
The FDA decision is informed by the results of the 20vPnC Phase 2 randomized, double-blind trial to evaluate the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in adults 60 through 64 years of age. Pfizer will seek to present and publish outcomes from this clinical trial at a future date.
“We look forward to continuing our dialogue with the FDA so that we can accelerate the development program of the adult indication of Pfizer’s 20-valent next-generation pneumococcal vaccine candidate,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “There continues to be a global health need to protect against the potentially devastating effects of invasive pneumococcal disease and pneumonia caused by additional serotypes, and we are dedicated to continue to build on our expertise in pneumococcal conjugate vaccines with this vaccine candidate.”..

Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders

Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders

Vaccines and Global Health: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes. If you would like to suggest content to be included in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

 

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 focus 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

 

Research capacity building frameworks for allied health professionals – a systematic review

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 22 Sep 2018)

Research article
Research capacity building frameworks for allied health professionals – a systematic review
Building the capacity of allied health professionals to engage in research has been recognised as a priority due to the many benefits it brings for patients, healthcare professionals, healthcare organisations …
Authors: Janine Matus, Ashlea Walker and Sharon Mickan
Citation: BMC Health Services Research 2018 18:716
Published on: 15 September 2018

Immunogenicity of the CYD tetravalent dengue vaccine using an accelerated schedule: randomised phase II study in US adults

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 22 Sep 2018)

Research article
Immunogenicity of the CYD tetravalent dengue vaccine using an accelerated schedule: randomised phase II study in US adults
The live attenuated tetravalent dengue vaccine (CYD-TDV) is licensed using a 0-, 6- and 12-month schedule in dengue-endemic areas. An effective shorter schedule may provide more rapid, optimal protection of ta…
Authors: Judith Kirstein, William Douglas, Manoj Thakur, Mark Boaz, Thomas Papa, Anna Skipetrova and Eric Plennevaux
Citation: BMC Infectious Diseases 2018 18:475
Published on: 21 September 2018

Back to the future, again: greater leadership, collaboration and accountability to accelerate progress to end TB

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 22 Sep 2018)

Commentary
Back to the future, again: greater leadership, collaboration and accountability to accelerate progress to end TB
A first UN General Assembly high-level meeting on the fight against tuberculosis (TB) will take place on September 26, 2018. It offers the opportunity to forge new concrete commitments and action needed to fin…
Authors: Diana Weil, Kristijan Marinkovic and Tereza Kasaeva
Citation: BMC Medicine 2018 16:172
Published on: 19 September 2018

Attitudes and barriers associated with seasonal influenza vaccination uptake among public health students; a cross-sectional study

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 22 Sep 2018)

Research article
Attitudes and barriers associated with seasonal influenza vaccination uptake among public health students; a cross-sectional study
Although research has explored influenza vaccination uptake among medical and college students, there is a dearth of research in understanding influenza vaccination uptake and attitudes toward the vaccine amon…
Authors: Christopher J. Rogers, Kaitlin O. Bahr and Stephanie M. Benjamin
Citation: BMC Public Health 2018 18:1131
Published on: 20 September 2018

Factors Associated with Human Papillomavirus Vaccination Among Diverse Adolescents in a Region with Low Human Papillomavirus Vaccination Rates

Health Equity
Issue in Progress
https://www.liebertpub.com/toc/heq/2/1

Open Access
Factors Associated with Human Papillomavirus Vaccination Among Diverse Adolescents in a Region with Low Human Papillomavirus Vaccination Rates
Deanna Kepka, Julia Bodson, Djin Lai, Ana Sanchez-Birkhead, Jeannette Villalta, Valentine Mukundente, Fahina Tavake-Pasi, France A. Davis, Doriena Lee, Edwin Napia, Ryan Mooney,
Heather Coulter, and Louisa A. Stark
Pages:223–232
Published Online:1 September 2018
https://doi.org/10.1089/heq.2018.0028

Uncovering the mechanisms of research capacity development in health and social care: a realist synthesis

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 22 Sep 2018]

Review
Uncovering the mechanisms of research capacity development in health and social care: a realist synthesis
Authors: Jo Cooke, Paolo Gardois and Andrew Booth
Citation: Health Research Policy and Systems 2018 16:93
Published on: 21 September 2018
Abstract
Background
Research capacity development (RCD) is considered fundamental to closing the evidence–practice gap, thereby contributing to health, wealth and knowledge for practice. Numerous frameworks and models have been proposed for RCD, but there is little evidence of what works for whom and under what circumstances. There is a need to identify mechanisms by which candidate interventions or clusters of interventions might achieve RCD and contribute to societal impact, thereby proving meaningful to stakeholders.
Methods
A realist synthesis was used to develop programme theories for RCD. Structured database searches were conducted across seven databases to identify papers examining RCD in a health or social care context (1998–2013). In addition, citation searches for 10 key articles (citation pearls) were conducted across Google Scholar and Web of Science. Of 214 included articles, 116 reported on specific interventions or initiatives or their evaluation. The remaining 98 articles were discussion papers or explicitly sought to make a theoretical contribution. A core set of 36 RCD theoretical and conceptual papers were selected and analysed to generate mechanisms that map across macro contexts (individual, team, organisational, network). Data were extracted by means of ‘If-Then’ statements into an Excel spreadsheet. Models and frameworks were deconstructed into their original elements.
Results
Eight overarching programme theories were identified featuring mechanisms that were triggered across multiple contexts. Three of these fulfilled a symbolic role in signalling the importance of RCD (e.g. positive role models, signal importance, make a difference), whilst the remainder were more functional (e.g. liberate talents, release resource, exceed sum of parts, learning by doing and co-production of knowledge). Outcomes from one mechanism produced changes in context to stimulate mechanisms in other activities. The eight programme theories were validated with findings from 10 systematic reviews (2014–2017).
Conclusions
This realist synthesis is the starting point for constructing an RCD framework shaped by these programme theories. Future work is required to further test and refine these findings against empirical data from intervention studies.

On the Prospects for a (Deep) Learning Health Care System

JAMA
September 18, 2018, Vol 320, No. 11, Pages 1083-1210
http://jama.jamanetwork.com/issue.aspx

Viewpoint
On the Prospects for a (Deep) Learning Health Care System
David Naylor, MD, DPhil
JAMA. 2018;320(11):1099-1100. doi:10.1001/jama.2018.11103
In this Viewpoint, David Naylor reviews factors driving the adoption of deep learning and artificial intelligence in health care, including the digitization of health data and efficiencies in processing those data sets to automate routine clinical tasks and accelerate research and technology development.

 

Deep Learning—A Technology With the Potential to Transform Health Care

JAMA
September 18, 2018, Vol 320, No. 11, Pages 1083-1210
http://jama.jamanetwork.com/issue.aspx

Viewpoint
Deep Learning—A Technology With the Potential to Transform Health Care
Geoffrey Hinton, PhD
JAMA. 2018;320(11):1101-1102. doi:10.1001/jama.2018.11100
In this Viewpoint, Geoffrey Hinton of Google’s Brain Team discusses the basics of neural networks: their underlying data structures, how they can be trained and combined to process complex health data sets, and future prospects for harnessing their unsupervised learning to clinical challenges.

Informatics, Data Science, and Artificial Intelligence

JAMA
September 18, 2018, Vol 320, No. 11, Pages 1083-1210
http://jama.jamanetwork.com/issue.aspx

Viewpoint
Informatics, Data Science, and Artificial Intelligence
Lisha Zhu, PhD; W. Jim Zheng, PhD
free access
JAMA. 2018;320(11):1103-1104. doi:10.1001/jama.2018.8211
This Viewpoint discusses how advances in data science and informatics are driving a transformation of biomedical research and clinical practice toward models where data mining and artificial intelligence will underlie development of precision therapies.
 

Meningococcal Group A, C, W, and Y Tetanus Toxoid Conjugate Vaccine: A Review of Clinical Data in Adolescents

Journal of Adolescent Health
September 2018 Volume 63, Issue 3, p263-376
https://www.jahonline.org/issue/S1054-139X(17)X0024-4

Review Article
Meningococcal Group A, C, W, and Y Tetanus Toxoid Conjugate Vaccine: A Review of Clinical Data in Adolescents
Lidia C. Serra, Laura J. York, Paul Balmer, Chris Webber
p269–279
Published in issue: September 2018

Evaluating Variability in Immunization Requirements and Policy Among U.S. Colleges and Universities

Journal of Adolescent Health
September 2018 Volume 63, Issue 3, p263-376
https://www.jahonline.org/issue/S1054-139X(17)X0024-4

Original Articles
Evaluating Variability in Immunization Requirements and Policy Among U.S. Colleges and Universities
Oluwatunmise A. Fawole, Tuhina Srivastava, Caitlin Fasano, Kristen A. Feemster
p286–292
Published in issue: September 2018

 

A Framework for Community and Stakeholder Engagement: Experiences From a Multicenter Study in Southern Africa

Journal of Empirical Research on Human Research Ethics
Volume 13 Issue 4, October 2018
http://journals.sagepub.com/toc/jre/current

A Framework for Community and Stakeholder Engagement: Experiences From a Multicenter Study in Southern Africa
Rosemary Musesengwa, Moses J. Chimbari, Samson Mukaratirwa
First Published April 27, 2018; pp. 323–332
Preview
Community and stakeholder engagement (CSE) are central to conducting multicenter health research. Multicenter studies are, however, considerably more complex because they involve a geographically diverse pool of participants and researchers, making uniform application of CSE strategies difficult. This article describes a framework to achieve CSE based on the experiences of a conducting a multicenter study in Southern Africa. The CSE framework is divided into three phases: before research commences, during, and after the study. This CSE framework offers a practical step-by-step guide on the operational aspects of CSE in a multicenter study. The framework shows the importance of consistent monitoring and evaluation during implantation of CSE.

Adolescent and Parental Attitudes About Return of Genomic Research Results: Focus Group Findings Regarding Decisional Preferences

Journal of Empirical Research on Human Research Ethics
Volume 13 Issue 4, October 2018
http://journals.sagepub.com/toc/jre/current

Parent and Child Perspectives on Research Participation
Adolescent and Parental Attitudes About Return of Genomic Research Results: Focus Group Findings Regarding Decisional Preferences
Michelle L. McGowan, Cynthia A. Prows, Melissa DeJonckheere, William B. Brinkman, Lisa Vaughn, Melanie F. Myers
First Published May 28, 2018; pp. 371–382
Preview
Opportunities to participate in genomic sequencing studies, as well as recommendations to screen for variants in 59 medically actionable genes anytime clinical genomic sequencing is performed, indicate adolescents will increasingly be involved in decisions about learning secondary findings from genome sequencing. However, how adolescents want to be involved in such decisions is unknown. We conducted five focus groups with adolescents (2) and parents (3) to learn their decisional preferences about return of genomic research results to adolescents. Discussions about decisional preferences centered around three themes: feelings about receiving genomic risk information, adolescent involvement and capacity to participate in decision-making, and recommendations for parental versus collaborative decision-making. We address the contested space between parental duties to act in their children’s best interests when choosing which results to return and adolescents’ desires to make autonomous decisions. A collaborative decision-making approach is recommended for obtaining consent from adolescents and their parents for genome sequencing research.

Mobile Game–Based Digital Vaccine for Reducing Risk of Lifestyle Diseases

Journal of Medical Internet Research
Vol 20, No 9 (2018): September
https://www.jmir.org/2018/9

Mobile Game–Based Digital Vaccine for Reducing Risk of Lifestyle Diseases
Rema Padman, Yi-Chin Kato-Lin, Bhargav SriPrakash, Sross Gupta, Palak Narang, Preethika Karthikeyan, Uttara Bharath-Kumar, Pradeep Krishnatray, Sanjeeta Agnihotri, Bhairavi Prakash, Vasini Varadan
iproc 2018 (Sep 17); 4(2):e11790

Blockchain Technology for Detecting Falsified and Substandard Drugs in Distribution: Pharmaceutical Supply Chain Intervention

Journal of Medical Internet Research
Vol 20, No 9 (2018): September
https://www.jmir.org/2018/9

Blockchain Technology for Detecting Falsified and Substandard Drugs in Distribution: Pharmaceutical Supply Chain Intervention
Patrick Sylim, Fang Liu, Alvin Marcelo, Paul Fontelo
JMIR Res Protoc 2018 (Sep 13); 7(9):e10163

NCD Countdown 2030: worldwide trends in non-communicable disease mortality and progress towards Sustainable Development Goal target 3.4

The Lancet
Sep 22, 2018 Volume 392 Number 10152 p985-1088
https://www.thelancet.com/journals/lancet/issue/current

Health Policy
NCD Countdown 2030: worldwide trends in non-communicable disease mortality and progress towards Sustainable Development Goal target 3.4
NCD Countdown 2030 collaborators

Variation in Childhood Diarrheal Morbidity and Mortality in Africa, 2000–2015

New England Journal of Medicine
September 20, 2018   Vol. 379 No. 12
http://www.nejm.org/toc/nejm/medical-journal

Original Articles
Variation in Childhood Diarrheal Morbidity and Mortality in Africa, 2000–2015
Diarrheal diseases are the third leading cause of disease and death in children younger than 5 years of age in Africa and were responsible for an estimated 30 million cases of severe diarrhea (95% credible interval, 27 million to 33 million) and 330,000 deaths (95% credible interval, 270,000 to 380,000) in 2015. The development of targeted approaches to address this burden has been hampered by a paucity of comprehensive, fine-scale estimates of diarrhea-related disease and death among and within countries.
Robert C. Reiner, Jr., Ph.D., Nicholas Graetz, M.P.H., Daniel C. Casey, M.P.H., Christopher Troeger, M.P.H., Gregory M. Garcia, B.S., Jonathan F. Mosser, M.D., Aniruddha Deshpande, M.P.H., Scott J. Swartz, M.S., Sarah E. Ray, B.S., Brigette F. Blacker, M.P.H., Puja C. Rao, M.P.H., Aaron Osgood-Zimmerman, M.S., Roy Burstein, B.A., David M. Pigott, D.Phil., Ian M. Davis, M.S., Ian D. Letourneau, B.A., Lucas Earl, M.Sc., Jennifer M. Ross, M.D., Ibrahim A. Khalil, M.D., Tamer H. Farag, Ph.D.,Oliver J. Brady, D.Phil., Moritz U.G. Kraemer, D.Phil., David L. Smith, Ph.D., Samir Bhatt, D.Phil., Daniel J. Weiss, Ph.D., Peter W. Gething, Ph.D., Nicholas J. Kassebaum, M.D., Ali H. Mokdad, Ph.D., Christopher J.L. Murray, M.D., and Simon I. Hay, D.Sc.

Towards national systems for continuous surveillance of antimicrobial resistance: Lessons from tuberculosis

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 22 Sep 2018)

Perspective
Towards national systems for continuous surveillance of antimicrobial resistance: Lessons from tuberculosis
Amitabh B. Suthar, Patrick K. Moonan, Heather L. Alexander
| published 14 Sep 2018 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002658

Coinfections and comorbidities in African health systems: At the interface of infectious and noninfectious diseases

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 22 Sep 2018)

Review
Coinfections and comorbidities in African health systems: At the interface of infectious and noninfectious diseases
Derick Nii Mensah Osakunor, David Moinina Sengeh, Francisca Mutapi
| published 20 Sep 2018 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0006711

Minutes to midnight: Turning back the Doomsday Clock through neglected disease vaccine diplomacy

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 22 Sep 2018)

Editorial
Minutes to midnight: Turning back the Doomsday Clock through neglected disease vaccine diplomacy
Peter J. Hotez
| published 20 Sep 2018 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0006676
[See Milestones above for detail]

 

The Pregnancy and Influenza Multinational Epidemiologic (PRIME) study: a prospective cohort study of the impact of influenza during pregnancy among women in middle-income countries

Reproductive Health
http://www.reproductive-health-journal.com/content
[Accessed 22 Sep 2018]

Study protocol
|   21 September 2018
The Pregnancy and Influenza Multinational Epidemiologic (PRIME) study: a prospective cohort study of the impact of influenza during pregnancy among women in middle-income countries
Authors: Fatimah S. Dawood, Danielle Hunt, Archana Patel, Wanitchaya Kittikraisak, Yeny Tinoco, Kunal Kurhe, Giselle Soto, Danielle Hombroek, Shikha Garg, Tawee Chotpitayasunondh, Oswaldo Gonzales, Savita Bhargav, Mark G. Thompson, Bajaree Chotpitayasunondh, Richard Florian, Amber Prakash…

How to Perform an Ethical Risk Analysis (eRA)

Risk Analysis          
Volume 38, Issue 9  Pages: 1763-2009  September 2018
https://onlinelibrary.wiley.com/toc/15396924/current

Original Research Articles
How to Perform an Ethical Risk Analysis (eRA)
Sven Ove Hansson
Pages: 1820-1829
First Published: 26 February 2018
Abstract
Ethical analysis is often needed in the preparation of policy decisions on risk. A three‐step method is proposed for performing an ethical risk analysis (eRA). In the first step, the people concerned are identified and categorized in terms of the distinct but compatible roles of being risk‐exposed, a beneficiary, or a decisionmaker. In the second step, a more detailed classification of roles and role combinations is performed, and ethically problematic role combinations are identified. In the third step, further ethical deliberation takes place, with an emphasis on individual risk‐benefit weighing, distributional analysis, rights analysis, and power analysis. Ethical issues pertaining to subsidiary risk roles, such as those of experts and journalists, are also treated in this phase. An eRA should supplement, not replace, a traditional risk analysis that puts emphasis on the probabilities and severities of undesirable events but does not cover ethical issues such as agency, interpersonal relationships, and justice.

Research on research

Science         
21 September 2018  Vol 361, Issue 6408
http://www.sciencemag.org/current.dtl
Special Issue; Metaresearch
Feature

Research on research
By Martin Enserink
Science21 Sep 2018 : 1178-1179 Full Access
A growing number of scientists is studying science itself.
Summary
The number of scientists who study science itself is growing rapidly, driven in part by the realization that science isn’t always the rigorous, objective search for knowledge it’s supposed to be. Editors of medical journals, embarrassed by the quality of the papers they were publishing, began to turn the lens of science on their own profession decades ago, creating a new field now named “journalology.” More recently, psychologists have taken the lead, plagued by existential doubts after many results proved irreproducible. Other fields are following suit, and metaresearch, or research on research, is now blossoming as a scientific field of its own.

A recipe for rigor

Science         
21 September 2018  Vol 361, Issue 6408
http://www.sciencemag.org/current.dtl
Special Issue; Metaresearch

A recipe for rigor
By Kai Kupferschmidt
Science21 Sep 2018 : 1192-1193 Full Access
A simple strategy to avoid bias—declaring in advance what you will study, and how—is rapidly catching on.
Summary
When a series of scandals hit the field of psychology in 2011 and eroded trust in a lot of research results, some scientists proposed a radical solution: preregistration, or describing the research they plan to do, and how, before they gather a single piece of data. Researchers hope this will lead to more negative results being published. But most importantly, it limits what scientists can do with their data, making practices like p-hacking or HARKing, which can lead to results that only seem to be significant, less likely. The practice has taken off since then, with the number of preregistrations doubling every year. Metaresearchers are now trying to suss out what positive or negative effects the new approach has. But that is proving difficult.

Toward a more scientific science

Science         
21 September 2018  Vol 361, Issue 6408
http://www.sciencemag.org/current.dtl
Special Issue; Metaresearch

Policy Forum
Toward a more scientific science
By Pierre Azoulay, Joshua Graff-Zivin, Brian Uzzi, Dashun Wang, Heidi Williams, James A. Evans, Ginger Zhe Jin, Susan Feng Lu, Benjamin F. Jones, Katy Börner, Karim R. Lakhani, Kevin J. Boudreau, Eva C. Guinan
Science21 Sep 2018 : 1194-1197
Summary
Climb atop shoulders and wait for funerals. That, suggested Newton and then Planck, is how science advances (more or less). We’ve come far since then, but many notions about how people and practices, policies, and resources influence the course of science are still more rooted in traditions and intuitions than in evidence. We can and must do better, lest we resign ourselves to “intuition-based policy” when making decisions and investments aimed at driving scientific progress. Science invited experts to highlight key aspects of the scientific enterprise that are steadily yielding to empirical investigation—and to explain how Newton and Planck got it right (and Einstein got it wrong).

 

 

Evidence-based medicine group expels internal critic

Science         
21 September 2018  Vol 361, Issue 6408
http://www.sciencemag.org/current.dtl
Special Issue; Metaresearch

In Depth
Evidence-based medicine group expels internal critic
By Martin Enserink
Science21 Sep 2018 : 1173-1174 Restricted Access
Cochrane is in turmoil after ousting co-founder Peter Gøtzsche, who accused it of becoming “industry-friendly.”
Summary
A crisis has erupted within Cochrane, an international network of scientists that promotes evidence-based medicine. On the eve of its annual meeting, held earlier this week in Edinburgh, Cochrane’s Governing Board voted to expel Peter Gøtzsche, director of the Nordic Cochrane Centre in Copenhagen and a board member himself. Gøtzsche, one of Cochrane’s most widely known researchers, says he was the victim of a “show trial,” likely instigated by Cochrane funders who disliked his highly critical views about pharma. But details about the procedure against him are shrouded in secrecy, and for Cochrane’s members and supporters it was hard to tell this week whether the bitter conflict is about scientific rigor, the limits of academic freedom within a large multinational organization, or a personality clash.

Comparison of adverse events following immunisation with acellular and whole-cell pertussis vaccines: A systematic review

Vaccine
Volume 36, Issue 40   Pages 5935-6038 (25 September 2018)
https://www.sciencedirect.com/journal/vaccine/vol/36/issue/40

Research article   Open access
Comparison of adverse events following immunisation with acellular and whole-cell pertussis vaccines: A systematic review
Jenna Patterson, Benjamin M. Kagina, Michael Gold, Gregory D. Hussey, Rudzani Muloiwa
Pages 6007-6016