Monthly Archives: November 2019

Perception of potential harm and benefits of HIV vaccine trial participation: A qualitative study from urban Tanzania

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PLoS One
http://www.plosone.org/
[Accessed 9 Nov 2019]

 

Research Article
Perception of potential harm and benefits of HIV vaccine trial participation: A qualitative study from urban Tanzania
Edith A. M. Tarimo, Joel Ambikile, Patricia Munseri, Muhammad Bakari
| published 08 Nov 2019 PLOS ONE
https://doi.org/10.1371/journal.pone.0224831

Hepatitis A and Hepatitis B Vaccination Coverage Among Persons Who Inject Drugs and Have Evidence of Hepatitis C Infection

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Public Health Reports
Volume 134 Issue 6, November/December 2019
https://journals.sagepub.com/toc/phrg/134/6

 

Research
Hepatitis A and Hepatitis B Vaccination Coverage Among Persons Who Inject Drugs and Have Evidence of Hepatitis C Infection
Ruth Koepke, MPH, Danielle N. Sill, MSPH, Wajiha Z. Akhtar, PhD, MPH, Kailynn P. Mitchell, MPH, Sheila M. Guilfoyle, BA, Ryan P. Westergaard, MD, PhD, MPH, Stephanie L. Schauer, PhD, James M. Vergeront, MD
First Published September 20, 2019; pp. 651–659

Developing product label information to support evidence-informed use of vaccines in pregnancy

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Vaccine
Volume 37, Issue 48 Pages 7123-7200 (15 November 2019)
https://www.sciencedirect.com/journal/vaccine/vol/37/issue/48

 

Research article Open access
Developing product label information to support evidence-informed use of vaccines in pregnancy
Terra A. Manca, Janice E. Graham, Ève Dubé, Melissa Kervin, … Karina A. Top
Pages 7138-7146

Disease Resurgence, Production Capability Issues and Safety Concerns in the Context of an Aging Population: Is There a Need for a New Yellow Fever Vaccine?

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Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 9 Nov 2019)

 

Open Access Review
Disease Resurgence, Production Capability Issues and Safety Concerns in the Context of an Aging Population: Is There a Need for a New Yellow Fever Vaccine?
by Kay M. Tomashek , Mark Challberg , Seema U. Nayak and Helen F. Schiltz
Vaccines 2019, 7(4), 179; https://doi.org/10.3390/vaccines7040179 (registering DOI) – 08 Nov 2019
Abstract
Yellow fever is a potentially fatal, mosquito-borne viral disease that appears to be experiencing a resurgence in endemic areas in Africa and South America and spreading to non-endemic areas despite an effective vaccine. This trend has increased the level of concern about the disease and the potential for importation to areas in Asia with ecological conditions that can sustain yellow fever virus transmission. In this article, we provide a broad overview of yellow fever burden of disease, natural history, treatment, vaccine, prevention and control initiatives, and vaccine and therapeutic agent development efforts

The Joint Committee on Vaccination and Immunisation’s Advice on Extending Human Papillomavirus Vaccination to Boys: Were Cost-Effectiveness Analysis Guidelines Bent to Achieve a Politically Acceptable Decision?

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Value in Health
November 2019 Volume 22, Issue 11, p1227-1344
https://www.valueinhealthjournal.com/issue/S1098-3015(19)X0011-X

 

COMMENTARY
The Joint Committee on Vaccination and Immunisation’s Advice on Extending Human Papillomavirus Vaccination to Boys: Were Cost-Effectiveness Analysis Guidelines Bent to Achieve a Politically Acceptable Decision?
James F. O’Mahony, Mike Paulden
p1227–1230
Published online: September 6, 2019

Unmet Medical Need: An Introduction to Definitions and Stakeholder Perceptions

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Value in Health
November 2019 Volume 22, Issue 11, p1227-1344
https://www.valueinhealthjournal.com/issue/S1098-3015(19)X0011-X

 

HEALTH POLICY ANALYSIS
Unmet Medical Need: An Introduction to Definitions and Stakeholder Perceptions
Rick A. Vreman, Inkatuuli Heikkinen, Ad Schuurman, Claudine Sapede, Jordi Llinares Garcia, Niklas Hedberg, Dimitrios Athanasiou, Jens Grueger, Hubert G.M. Leufkens, Wim G. Goettsch
p1275–1282
Published online: September 6, 2019
Open Access

Pneumococcal Disease: A Systematic Review of Health Utilities, Resource Use, Costs, and Economic Evaluations of Interventions

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Value in Health
November 2019 Volume 22, Issue 11, p1227-1344
https://www.valueinhealthjournal.com/issue/S1098-3015(19)X0011-X

 

SYSTEMATIC LITERATURE REVIEW
Pneumococcal Disease: A Systematic Review of Health Utilities, Resource Use, Costs, and Economic Evaluations of Interventions
Tinevimbo Shiri, Kamran Khan, Katherine Keaney, Geetanjali Mukherjee, Noel D. McCarthy, Stavros Petrou
p1329–1344
Published online: September 10, 2019

Media/Policy Watch

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Media/Policy Watch
This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.
We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

 

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 9 Nov 2019
[No new, unique, relevant content]

 

BBC
http://www.bbc.co.uk/
Accessed 9 Nov 2019
[No new, unique, relevant content]

 

The Economist
http://www.economist.com/
Accessed 9 Nov 2019
Broad-banned internet
Countries are increasingly willing to censor speech online
That will make life hard for the tech giants
Nov 7th 2019
In 2016 the World Health Organisation (WHO) declared Britain to be officially free from measles, a highly infectious illness that killed about 110,000 people around the world in 2017. The success was short-lived. After 991 infections were recorded in England and Wales in 2018, the WHO revoked Britain’s disease-free label.
Cases of measles are rising in many countries, fuelled in part by conspiracy theories claiming that vaccines given to children cause autism (they do not). “Anti-vaxxers” have long used internet forums and social media to spread their nonsense. Matt Hancock, Britain’s health minister, would like to see that stopped. In March he said that internet giants such as Facebook and Google should have a “duty of care” to their users, putting them in the same legal position as schools or doctors. If firms would not stop the spread of anti-vaccination messages voluntarily, said Mr Hancock, he would consider changing the law to force them to do so…

 

Financial Times
http://www.ft.com/home/uk
Accessed 9 Nov 2019
[No new, unique, relevant content]

 

Forbes
http://www.forbes.com/
Accessed 9 Nov 2019
Nov 3, 2019
Bill Maher Supports Vaccine-Autism Connection
On the November 1, 2019 episode of “Real Time with Bill Maher,” he had a conversation with pediatrician Jay Gordon, MD, known for providing troves of high-profile families with personal belief exemptions and medical exemptions to postpone or forego vaccinations for their children.
By Nina Shapiro Contributor

Nov 2, 2019
The Political Battlefield Of Infections And Migrant Children’s Bodies
Deaths from influenza have occurred among migrant children in detention. Yet the US government is denying them flu vaccination, and recently went to court arguing that children are not entitled to basic sanitation, clean clothes, bathing, and toothbrushes.
By Judy Stone Senior Contributor

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 9 Nov 2019
[No new, unique, relevant content]

Foreign Policy
http://foreignpolicy.com/
Accessed 9 Nov 2019
[No new, unique, relevant content]

 

The Guardian
http://www.guardiannews.com/
Accessed 9 Nov 2019
Pakistan accused of cover-up over fresh polio outbreak
Source claims government plans secret vaccinations after 12 children fall prey to disease
Nov 7, 2019
Officials in Pakistan have been accused of covering up an outbreak of the most dangerous strain of polio and planning a covert vaccination programme to contain the disease.
According to a source in Pakistan’s polio eradication programme and documentation seen by the Guardian, a dozen children have been infected with the P2 strain of polio, which causes paralysis and primarily effects those under five.
Dr Malik Safi, coordinator of the national emergency operation centre of the Pakistan polio eradication programme, confirmed the P2 outbreak, but would not give any further comment…

 

New Yorker
http://www.newyorker.com/
Accessed 9 Nov 2019
[No new, unique, relevant content]

 

New York Times
http://www.nytimes.com/
Accessed 9 Nov 2019
Asia Pacific
Chinese Company in Vaccine Scandal Declared Bankrupt
A Chinese maker of rabies vaccine that was fined 9.1 billion yuan ($1.3 billion) in a quality scandal that set off a crackdown on the industry said Friday it has been declared bankrupt.
By The Associated Press Nov. 8

 

Washington Post
https://www.washingtonpost.com/
Accessed 9 Nov 2019
[No new, unique, relevant content]

Think Tanks et al

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Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 9 Nov 2019
[No new relevant content]

 

Center for Global Development
http://www.cgdev.org/page/press-center
Accessed 9 Nov 2019
[No new relevant content]

 

CSIS
https://www.csis.org/
Accessed 9 Nov 2019
[No new relevant content]

 

Council on Foreign Relations
http://www.cfr.org/
Accessed 9 Nov 2019
[No new relevant content]

 

Kaiser Family Foundation
https://www.kff.org/search/?post_type=pre ss-release
[No new relevant content]

Vaccines and Global Health: The Week in Review :: 02 November 2019

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Vaccines and Global Health: The Week in Review :: 26 October 2019

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

.– Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

– pdf version:  A pdf of the current issue is available here:Vaccines and Global Health_The Week in Review_2 Nov 2019

– blog edition: comprised of the approx. 35+ entries posted below.

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
.
– Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.

Support this knowledge-sharing service: Your financial support helps us cover our costs and to address a current shortfall in our annual operating budget. Click here to donate and thank you in advance for your contribution.

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

Milestones :: Perspectives :: Research CNBC Africa

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Milestones :: Perspectives :: Research

 

CNBC Africa
Op-Ed: Reinventing immunisation in Africa
October 25, 2019
By Dr. Jean-Marie Okwo-Bele is the Former Director, Department of Immunization, Vaccines and Biologicals at the World Health Organization and Dr. Richard Mihigo is the Immunization and Vaccines Development Program Coordinator at the World Health Organization Regional Office for Africa.

In the current outbreak of Ebola in the Democratic Republic of Congo a promising new investigational vaccine is proven pivotal in controlling this much-feared and often fatal disease. The innovative solution was first tested in the West Africa Ebola outbreak in complementarity with other interventions.

Such findings highlight the stark improvement and expansion that has occurred to African immunization services in the last 40 years. There is however, still need for more robust policies for immunization, featuring sustainable programs funded on a country-by-country basis. Our global imperative is to bridge the vaccination gap prevalent around the world, our focus is, however, on Africa.

The Addis Declaration on Immunization of 2016 – was an important stepping-stone towards our end. It brought together all 54 African countries to recognize the need to accelerate progress on the goals of the Global Vaccine Action Plan for the 2011-2020 Decade.

This Declaration represents a drive toward meeting a key UN Sustainable Development Goal, namely universal health coverage. Ongoing investment in vaccine research and development – and in large-scale immunization programs – is essential for preserving individual health and population security.

Only through high-level leadership, increased resources and a continent-wide commitment can we expect to achieve the ambitious immunization goals we have set out for ourselves.
How to turn this crusade into reality? How best to leverage our existing immunization infrastructure and establish long-term public-private partnerships. We hereby propose the following steps, all potentially transformative, to maintain our hard-earned momentum.

First, we should anchor immunization within primary healthcare. Vaccines should be regarded as key interventions, whether for pneumonia, diarrhea, cholera or typhoid. Immunization can also serve as a platform for treating neglected tropical diseases such as malaria and helminthiasis. Creating integrated management protocols would drive efficiency system-wide. It would represent a long-overdue shift from a disease-specific approach and help bring about universal healthcare.[1]

Next, we should guarantee the funding required for immunization. This is an absolute imperative. Preferably funds would come from national governments and respective partners, rather than from individual households making out-of-pocket payments. Already, for example, eight countries in the region[2], fully finance their own immunization activities. Every country should develop its own immunization financing plan, whether through taxes, special levies, loans, insurance premiums, or some combination thereof. Ultimately, the source of funding is vastly less important than sustaining it.[3]

Demand for vaccination needs to be created too. Key organizations involved should mount concerted national efforts to educate communities to appreciate and seek out immunization. So recommended the 2017 Assessment Report of the Global Vaccine Action Plan. It called for “ongoing community engagement and trust-building, active hesitancy prevention, regular national assessment of vaccine concerns, and crisis response planning.”[4]. It is vital to remember the warning from the World Health Organization about vaccine hesitancy – the reluctance or refusal to vaccinate despite the availability of vaccines – namely, that it’s a threat to global public health[5].

Bridging the gap in access to vaccines between locations and populations is essential as well. Data can help target those most in need. Integrated strategies and sustained funding should minimize the inequalities in immunization service delivery — disparities in access, coverage and geographic diversity, as well as cultural and economic bias – so widespread over the last two decades. Programs should be tailored for given communities – for example, by collaborating with managers to plan health services around extreme weather events or humanitarian crises.

Likewise, it is vital to strengthen the micro-planning processes for local officials and communities in order to maximize access to immunization services and ensure future success. Precisely how our services are delivered – and how well – will matter more than ever. Case in point:  As in Rwanda and Tanzania, community health workers are deployed to connect target populations with the services needed and prevent individuals from being left behind.

Throughout all these steps, we must keep innovating, collaborating and learning from each other. In the process, we should focus support on those most responsible for delivering immunization services in Africa. Make no mistake: business-as-usual approaches will no longer drive the improvements so desperately needed.

Lastly, technology and digital communications will have to be harnessed to enhance services, accuracy and accountability. At the moment, mobile telecommunications in Africa hold promise but remain desperately underused. Bringing in new technology – such as Geographic Information Systems – can limit over-reporting, identify new settlements and improve vaccine storage facilities, among numerous other advantages.

These concrete, forward-looking actions should guide our agenda to reimagine – and in so doing, reform — immunization policy in Africa over the next 10 years. Only then can we do the job we are supposed to do and keep preventing, controlling and even eliminating diseases. Only then will we fulfill our humanitarian purpose to raise immunization rates, protect communities and save the lives of children and other vulnerable populations across the continent.

[1] World Health Organization. Working Together: an integration resource guide for immunization services throughout the life course. WHO 2018. https://apps.who.int/iris/bitstream/handle/10665/276546/9789241514736-eng.pdf?ua=1
[2] Algeria, Angola, Botswana, Equatorial Guinea, Gabon, Mauritius, Namibia, and South Africa
[3] Saxenian H, et al. Overcoming challenges to sustainable immunization financing: early experiences from GAVI graduating countries. Health Policy and Planning (2015); 30(2): 197–205, https://academic.oup.com/heapol/article/30/2/197/622945
[4] Strategic Advisory Group of Experts on Immunization. Geneva: World Health Organization; 2017. License: CC BYNC-SA 3.0 IGO.
[5] World Health Organization. Ten threats to global health in 2019. WHO 2019. https://www.who.int/emergencies/ten-threats-to-global-health-in-2019

Milestones :: Perspectives :: Research TB Vaccine

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Milestones :: Perspectives :: Research

 

TB Vaccine

 

New England Journal of Medicine
October 25, 2018 DOI: 10.1056/NEJMoa1803484
Original Article
Phase 2b Controlled Trial of M72/AS01E Vaccine to Prevent Tuberculosis
Olivier Van Der Meeren, M.D., Mark Hatherill, M.D., Videlis Nduba, M.B., Ch.B., M.P.H., Robert J. Wilkinson, F.Med.Sci., Monde Muyoyeta, M.B., Ch.B., Ph.D., Elana Van Brakel, M.B., Ch.B., Helen M. Ayles, M.B., B.S., Ph.D., German Henostroza, M.D., Friedrich Thienemann, M.D., Thomas J. Scriba, Ph.D., Andreas Diacon, M.D., Ph.D., Gretta L. Blatner, M.S., M.P.H., Marie-Ange Demoitié, M.Sc., Michele Tameris, M.B., Ch.B., Mookho Malahleha, M.D., M.P.H., James C. Innes, M.B., Ch.B., Elizabeth Hellström, M.B., Ch.B., Neil Martinson, M.B., Ch.B., M.P.H., Tina Singh, M.D., Elaine J. Akite, M.Sc., Aisha Khatoon Azam, M.B., B.S., Anne Bollaerts, M.Sc., Ann M. Ginsberg, M.D., Ph.D., Thomas G. Evans, M.D., Paul Gillard, M.D., and Dereck R. Tait, M.B., Ch.B.
Abstract
Background
A vaccine to interrupt the transmission of tuberculosis is needed.
Methods
We conducted a randomized, double-blind, placebo-controlled, phase 2b trial of the M72/AS01E tuberculosis vaccine in Kenya, South Africa, and Zambia. Human immunodeficiency virus (HIV)–negative adults 18 to 50 years of age with latent M. tuberculosis infection (by interferon-γ release assay) were randomly assigned (in a 1:1 ratio) to receive two doses of either M72/AS01E or placebo intramuscularly 1 month apart. Most participants had previously received the bacille Calmette–Guérin vaccine. We assessed the safety of M72/AS01E and its efficacy against progression to bacteriologically confirmed active pulmonary tuberculosis disease. Clinical suspicion of tuberculosis was confirmed with sputum by means of a polymerase-chain-reaction test, mycobacterial culture, or both.
Results
We report the primary analysis (conducted after a mean of 2.3 years of follow-up) of the ongoing trial. A total of 1786 participants received M72/AS01E and 1787 received placebo, and 1623 and 1660 participants in the respective groups were included in the according-to-protocol efficacy cohort. A total of 10 participants in the M72/AS01E group met the primary case definition (bacteriologically confirmed active pulmonary tuberculosis, with confirmation before treatment), as compared with 22 participants in the placebo group (incidence, 0.3 cases vs. 0.6 cases per 100 person-years). The vaccine efficacy was 54.0% (90% confidence interval [CI], 13.9 to 75.4; 95% CI, 2.9 to 78.2; P=0.04). Results for the total vaccinated efficacy cohort were similar (vaccine efficacy, 57.0%; 90% CI, 19.9 to 76.9; 95% CI, 9.7 to 79.5; P=0.03). There were more unsolicited reports of adverse events in the M72/AS01E group (67.4%) than in the placebo group (45.4%) within 30 days after injection, with the difference attributed mainly to injection-site reactions and influenza-like symptoms. Serious adverse events, potential immune-mediated diseases, and deaths occurred with similar frequencies in the two groups.
Conclusions
M72/AS01E provided 54.0% protection for M. tuberculosis–infected adults against active pulmonary tuberculosis disease, without evident safety concerns. (Funded by GlaxoSmithKline Biologicals and Aeras; ClinicalTrials.gov number, NCT01755598. opens in new tab.)

Milestones :: Perspectives :: Research Drug Shortages

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Milestones :: Perspectives :: Research

 

Drug Shortages

Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on FDA’s new report regarding root causes and potential solutions to drug shortages
Oct 29, 2019, 11:05 ET
…Today, on behalf of the inter-agency Task Force, the FDA issued a report, “Drug Shortages: Root Causes and Potential Solutions,” that attempts to identify root causes and offer recommendations for government and industry based on insights gleaned from stakeholders in the private and public sectors. These recommendations are intended to help prevent and mitigate future drug shortages. The report focuses on human drugs, but many of the same concerns apply to veterinary medicines used to treat service, companion, and food-producing animals.
The Task Force found that the number of ongoing drug shortages has been rising, and that their impact is likely underappreciated. The Task Force analyzed 163 drugs that went into shortage from 2013 to 2017 and compared these medicines to similar drugs that did not go into shortage. Shortage drugs were more likely to be relatively low-price and financially unattractive drugs and were more likely to be sterile injectables. Shortages often occurred as a result of disruption in supply due to a variety of factors. Importantly, prices rarely rose after shortages began, and during shortages, production typically did not increase enough to restore supply to pre-shortage levels. Many manufacturers reported discontinuing the production of drugs before a shortage for commercial reasons (e.g., loss of profitability)…

Drug Shortages: Root Causes and Potential Solutions
A Report by the Drug Shortages Task Force 2019
FDA, October 2019 :: 124 pages
PDF: https://www.fda.gov/media/132059/download
Overview
Drug Shortages: Root Causes and Potential Solutions examines the underlying factors responsible for drug shortages and recommends enduring solutions. The inter-agency Drug Shortage Task Force, which was led by FDA, oversaw the analysis of drug shortage data and development of recommendations in response to a request from 31 U.S. senators and 104 U.S. congressional representatives in June 2018. The report relies on information from stakeholders, published research, and economic analysis of market conditions affecting drug shortages.

The report identifies three root causes for drug shortages:
:: Lack of incentives for manufacturers to produce less profitable drugs;
:: The market does not recognize and reward manufacturers for “mature quality systems” that focus on continuous improvement and early detection of supply chain issues; and
:: Logistical and regulatory challenges make it difficult for the market to recover from a disruption.

The report also recommends enduring solutions to address drug shortages. These solutions include:
:: Creating a shared understanding of the impact of drug shortages on patients and the contracting practices that may contribute to shortages;
:: Developing a rating system to incentivize drug manufacturers to invest in quality management maturity for their facilities; and
:: Promoting sustainable private sector contracts (e.g., with payers, purchasers, and group purchasing organizations) to make sure there is a reliable supply of medically important drugs.

In addition, the report describes legislative proposals in the President’s FY2020 Budget and planned FDA initiatives to prevent and mitigate shortages that look at improved data sharing, risk management, lengthened expiration dates for drugs, and internationally harmonized guidelines for a pharmaceutical quality system.

Emergencies

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Emergencies

Ebola – DRC+
Public Health Emergency of International Concern (PHEIC)

No new Situation Update posted.

::::::

Global consortium working with DRC Government to introduce second Ebola vaccine
31 Oct 2019 CEPI
A global consortium is supporting the Government of the Democratic Republic of the Congo (DRC) to introduce a second investigational Ebola vaccine as part of ongoing efforts to contain the outbreak in eastern DRC.

The large-scale clinical trial, sponsored by the London School of Hygiene & Tropical Medicine (LSHTM), is designed to help prevent the spread of the epidemic, the second worst in history, beyond the currently affected areas in eastern DRC, and if possible gather crucial information about the effectiveness of the vaccine to be better prepared to fight Ebola in the future.

The consortium is led by the DRC Ministry of Health (MOH) and Institut National de Recherche Biomédicale (INRB) and includes LSHTM, the Coalition for Epidemic Preparedness Innovations (CEPI); Médecins Sans Frontières (MSF) and Epicentre; with the Wellcome Trust contributing critical strategic guidance. Janssen Vaccines & Prevention B.V. is donating the experimental vaccine regimen for the study undertaken by the consortium.

The two-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) is manufactured by the Janssen Pharmaceutical Companies of Johnson & Johnson. It was developed in collaboration with global partners, including Bavarian Nordic A/S, the U.S. Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), the Innovative Medicines Initiative (IMI) funded through the European Union Horizon 2020 Programme, and the U.S. National Institutes of Health (NIH) at HHS.

The introduction of this second vaccine was recommended by the World Health Organization’s Strategic Advisory Group of Experts on Immunization in May 2019 to complement ongoing use of another investigational vaccine, rVSV-ZEBOV, made by Merck Pharmaceuticals. The Merck vaccine is being used in a ring vaccination strategy targeting contacts of those with Ebola virus disease and other health and frontline workers at high risk.

More than 6,500 people have taken part in multiple previous and ongoing clinical trials of the Janssen Ebola vaccine regimen. The available data indicate that the vaccine is well tolerated and induces robust immune responses to the Zaire strain of Ebola virus – the cause of the DRC outbreak. At present, there are no human data on efficacy in preventing Ebola virus infection.
In 2019 researchers in Uganda began a two-year clinical trial of the vaccine among healthcare and frontline workers. The vaccine is also undergoing evaluation along with the Merck vaccine as part of a large Phase 2 randomized, placebo-controlled trial in West Africa called PREVAC that began in 2017.

Ad26.ZEBOV, MVA-BN-Filo will be offered to adults and children aged one year or older under a clinical trial protocol that aims to evaluate the effectiveness and safety of the vaccine in an outbreak setting. The regimen includes two doses (one of Ad26.ZEBOV and the second of MVA-BN-Filo), spaced two months apart.

Janssen will donate up to 500,000 doses of the vaccine regimen for those in communities near the outbreak who are considered at risk, as determined by the DRC MOH, INRB and consortium partners, taking into account the latest epidemiological data on disease spread, as well as logistical and security concerns.

Dr Eteni Longondo, Minister of Public Health, DRC, said: “As part of our Ebola response efforts, the Government of DRC plans to introduce a second experimental Ebola vaccine within a clinical trial protocol. It’s vital that we intensify our efforts. That’s why we’re working with international partners to provide our response teams with another tool to fight and ultimately stop the spread of this terrible disease.”

The study will be implemented by the INRB and MOH, supported by MSF, Epicentre, and LSHTM under the leadership of the Principal Investigator Dr Jean-Jacques Muyembe, INRB Director General and head of the DRC multisector Ebola response committee.

Dr Muyembe said: “The current Ebola outbreak is concentrated in North Kivu and Ituri provinces, areas which have had to deal with insecurity and violent conflict. This environment has complicated response efforts and led to distrust of health care workers, which has become a major problem. Therefore, effective community engagement will be absolutely critical to the successful introduction of a second Ebola vaccine. Deploying any vaccine in these circumstances is enormously challenging and must be done alongside a range of other public health measures and interventions, such as contact tracing. But building trust and confidence within affected communities must be our priority.”…
country….

::::::
::::::

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 30 October 2019
:: With less than a month left to the GPEI pledging event in Abu Dhabi, G20 Health Ministers gathered in Okayama, Japan, on 19 – 20 October 2019 to address major global health issues where they maintained their commitment to eradicating polio. Read more on the ministers’ declaration.
:: Following the certification of eradication of WPV3, WHO Director General Dr Adhanom Ghebreyesus expressed his gratitude to all who made the achievement possible and called on all stakeholders to continue with the fight to eradicate WPV1. Read the DG’s thank-you letter.
:: The effects of polio hit hard. The disease not only causes pain and suffering to the victim and the family, but also forces relatives to quit their income-generating activities, to provide care to the afflicted child. Read about little Junaisa – the first polio patient in the Philippines since 2001.
:: Get up-to-date on the different aspects of GPEI’s status of work in 2018 through the newly released 2018 annual report.

 

Summary of new viruses this week:
:: Afghanistan— one WPV1 case;
:: Pakistan— one WPV1 case and 12 WPV1-positive environmental samples;
:: Central African Republic— three cVDPV2 cases and one cVDPV2 positive environmental sample. Angola— 11 cVDPV2 cases;
:: Philippines— one cVDPV2 case, one cVDPV1 and two cVDPV2 positive environmental samples.

::::::

Okayama Declaration of the G20 Health Ministers
October 19-20, 2019
…
12. We reaffirm our commitment to eradicate polio, and we note the leadership role of WHO.
We are concerned with the rising number of vaccine-derived polio outbreaks. We call for
a strong cross-border cooperation and strict implementation of vaccine requirements for
travelers as specified in the International Health Regulations (IHR, 2005). We support the
efforts of the Global Polio Eradication Initiative (GPEI), Gavi, the Vaccine Alliance (Gavi),
WHO, UNICEF, and other stakeholders in strengthening routine and supplemental
immunization. We also support their efforts to ensure transition of relevant polio assets
into the national programs and we encourage countries to provide adequate domestic
resources to strengthen national health systems. We look forward to the replenishment of
GPEI next month.

13. We recognize that immunization is one of the most cost-effective health investments with
proven strategies that make it accessible to all segments of the population with an
emphasis on women and girls, the most hard-to-reach as well as the vulnerable and
marginalized populations. We express our concern about vaccine hesitancy as mentioned
in the WHO’s Ten threats to global health in 2019. We are committed to strengthen health
systems and accessibility of safe, effective, quality, and affordable vaccines for sustainable
immunization to achieve high vaccination coverage as well as confidence in vaccines. We
look forward to the third replenishment of Gavi next year in the United Kingdom…

::::::

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 2 Nov 2019]

Democratic Republic of the Congo
:: 835 000 people to receive second dose of the cholera vaccine in North Kivu, Democratic Republic of the Congo Goma, 30 October 2019

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 2 Nov 2019]

Myanmar
:: Bi‐weekly Situation Report 21 – 24 October 2019 pdf, 639kb

Niger
:: Evaluation externe de la riposte (OBRA) à l’épidémie de poliomyélite 31 octobre 2019

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
HIV in Pakistan – No new digest announcements identified
Iran floods 2019 – No new digest announcements identified
Iraq – 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
occupied Palestinian territory – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

::::::

WHO Grade 1 Emergencies [to 2 Nov 2019]

Chad – No new digest announcements identified
Djibouti – No new digest announcements identified
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

::::::
::::::

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
:: Syria ǀ Flash Update #10, Humanitarian impact of the military operation in north-eastern Syria, 26 – 28 October 2019 [EN/AR]

Yemen – No new digest 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.
Editor’s Note:
Ebola in the DRC has bene added as a OCHA “Corporate Emergency” this week:
CYCLONE IDAI and Kenneth
:: 01 Nov 2019 Kenya: Heavy rains impact more than 100,000 people

EBOLA OUTBREAK IN THE DRC – No new digest announcements identified

::::::
::::::

WHO & Regional Offices [to 2 Nov 2019]

Posted on by

WHO & Regional Offices [to 2 Nov 2019]

New WHO report to bolster efforts to tackle leading causes of urban deaths
Report launched on World Cities Day offers tools for city leaders to tackle deaths through non-communicable diseases and road traffic injuries.
31 October 2019

 

::::::

Weekly Epidemiological Record, 1 November 2019, vol. 94, 44 (pp. 505–512)
:: Validation of maternal and neonatal tetanus elimination in the Democratic Republic of the Congo
:: Monthly report on dracunculiasis cases, January-September 2019
::::::

 

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: 835 000 people to receive second dose of the cholera vaccine in North Kivu, Democratic Republic of the Congo Goma, 30 October 2019

WHO Region of the Americas PAHO
:: Partners join forces in Brazil to eliminate yellow fever epidemics in the world (10/30/2019)

WHO South-East Asia Region SEARO
No new digest content identified.

WHO European Region EURO
:: WHO releases new guidance on treating drug-resistant tuberculosis in children and adolescents 31-10-2019

WHO Eastern Mediterranean Region EMRO
:: WHO and partners mark World Polio Day throughout Pakistan 29 October 2019
:: WHO, Federal Ministry of Health and partners mobilize 3.3 million doses of oral cholera vaccine in Sudan 29 October 2019
:: World Polio Day 2019: Sudan celebrates global eradication of wild poliovirus type 3 27 October 2019

WHO Western Pacific Region
No new digest content identified.

China CDC

Posted on by

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/
Selected Updates and Press Releases
China urges flu vaccination for high-risk groups
2019-11-01
Chinese health authorities on Oct 30 suggested flu vaccinations for children, the elderly, patients of chronic diseases and medical workers before the peak season of the disease arrives.

Flu vaccine stockpile to double this season
2019-10-31
The supply of flu vaccines in China this year will be twice as large as last year to ensure demand is met, the top health authority said on Wednesday, adding it is well prepared for the arrival of flu season.

Announcements

Posted on by

Announcements

 

Paul G. Allen Frontiers Group [to 2 Nov 2019]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BMGF – Gates Foundation [to 2 Nov 2019]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 2 Nov 2019]
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 2 Nov 2019]
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.
10.29.2019  |
CARB-X funds BioVersys to support the development of first-in-class anti-virulence small molecule drugs designed to disarm bacteria, opening the door for a paradigm shift in the treatment of drug resistant bacterial infections
BioVersys’ new medicine would be used as a stand-alone to treat uncomplicated skin and skin structure infections (SSSI) or in combination with antibiotics for more severe infections

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 2 Nov 2019]
http://cepi.net/
News
Global consortium working with DRC Government to introduce second Ebola vaccine
Trial aims to help tackle outbreak and strengthen future Ebola epidemic preparedness.
News 31 Oct 2019
[See Milestones above for detail]

Themis Bioscience and CEPI Announce Initiation of Phase 1 Clinical Trial with Lassa Fever Vaccine
Vienna, Austria and Oslo, Norway, October 29, 2019 – Themis Bioscience and CEPI – the Coalition for Epidemic Preparedness Innovations – announced today the first administration to healthy volunteers in a Phase 1 clinical trial with Themis’ vaccine candidate against Lassa fever. The MV-LASV Lassa fever vaccine candidate, is based on Themis’ proprietary measles vector platform and exclusively-licensed discoveries made at Institut Pasteur. The MV-LASV Lassa fever vaccine program is funded through a global partnership with CEPI that will support the candidate vaccine’s development up to the end of Phase 2, which is designed to provide clinical safety and immunological data. The investment, which was the first in CEPI’s portfolio, will also help establish investigational stockpiles of Themis’ vaccine candidate that will be ready for clinical efficacy trial testing during outbreaks….

 

Clinton Health Access Initiative, Inc. (CHAI) [to 2 Nov 2019]
https://clintonhealthaccess.org/about/
News & Press Releases
Nigeria launches public-private partnership to ensure affordable access to high-quality chemotherapies at seven teaching hospitals
ABUJA, NIGERIA, Oct. 29, 2019 — Nigeria’s Federal Ministry of Health today announced an innovative partnership to deliver lifesaving chemotherapies for cancer treatment to seven teaching hospitals throughout the country. As a result of the partnership, Nigerians are expected to save up to 50 percent of their treatment costs, enabling thousands of additional patients to access care.
This new program, known as the Chemotherapy Access Partnership, between the Nigerian Federal Ministry of Health, the Clinton Health Access Initiative, Inc. (CHAI), the American Cancer Society (ACS), Pfizer, Inc., Worldwide Healthcare, and EMGE Resources, Limited, will enable people with cancer in Nigeria to access lower-priced, high-quality treatments at hospital pharmacies. The medications available under the program are of the same quality as those that would be received by patients in the United States, Europe, Canada, Japan, and Australia…

 

EDCTP [to 2 Nov 2019]
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 2 Nov 2019]
http://www.vaccines.emory.edu/
No new digest content identified.

 

European Medicines Agency [to 2 Nov 2019]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2019
PRAC, Last updated: 31/10/2019

 

European Vaccine Initiative [to 2 Nov 2019]
http://www.euvaccine.eu/news-events
No new digest content identified.

 

FDA [to 2 Nov 2019]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
October 29, 2019 – Digital submission of adverse event reports for investigational new drug applications reflects FDA’s ongoing modernization efforts
The U.S. Food and Drug Administration is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA’s Adverse Event Reporting System (FAERS). The planned process for submissions is outlined in a new draft guidance, and the FDA is also making available supporting technical specification documents. The changes will allow the FDA to access and review both pre- and post-market safety information in the same system and with the same data standard.

“In September, the FDA rolled out our Technology Modernization Action Plan (TMAP), an ambitious strategy that includes modernizing our technical infrastructure in ways that allow us to receive, analyze, and use data in new ways to advance the FDA’s regulatory mission,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “One way we are working to meet this goal is by designing technical interfaces and tools to enable the streamlined submission and review of data. Creating standard, digital IND safety reports is an important step toward more sophisticated data and technology solutions at the FDA to support efficient development of safe and effective medical products.”

The guidance outlines the FDA’s intent to implement a standard digital framework for the electronic submission, review and tracking of certain IND safety reports in FAERS. The publication of the draft guidance and technical documents should assist  sponsors in beginning preparations for when the draft guidance is finalized and effective…

 

Fondation Merieux [to 2 Nov 2019]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

 

Gavi [to 2 Nov 2019]
https://www.gavi.org/
Latest news
No new digest content identified.

 

GHIT Fund [to 2 Nov 2019]
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 2 Nov 2019]
https://www.theglobalfund.org/en/news/
News & Stories
News
Landmark Deal Secures Significant Discount on Price of Medicine to Prevent TB
31 October 2019
HYDERABAD, India – A landmark agreement announced today by Unitaid, the Global Fund to Fight AIDS, Tuberculosis and Malaria and global biopharmaceutical company Sanofi will significantly lower the price of rifapentine, a critically important drug used to prevent tuberculosis.
The deal will bolster efforts to treat latent TB infection – currently estimated to affect 1.7 billion people worldwide – by broadening access to better preventive therapy.
The volume-based agreement will discount the price of a three-month treatment course of rifapentine by nearly 70%, from approximately US$45 to US$15 in the public sectors of 100 low- and middle-income countries burdened by TB and TB/HIV coinfection.
“Effective TB prevention will be a game-changer in the global fight to eliminate one of the major killer diseases,” said Unitaid’s Executive Director Lelio Marmora. “This lifesaving drug has, until now, been completely unaffordable in developing countries. This agreement will help transform political commitment to tangible action.”…

 

Hilleman Laboratories [to 2 Nov 2019]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 2 Nov 2019]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.

 

IAVI [to 2 Nov 2019]
https://www.iavi.org/newsroom
October 29, 2019
GSK candidate vaccine demonstrates sustained level of protection against active pulmonary tuberculosis
Final analysis of phase IIb study published in the New England Journal of Medicine and presented at the 50th Union World Conference on Lung Health.
Final results confirm the innovative TB candidate vaccine’s efficacy level and acceptable safety profile in three-year clinical trial conducted in sub-Saharan African regions.

 

 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
ICMRA Summit Rome Meeting
October 31, 2019
ICMRA 2019 Summit Statement.pdf
ICMRA holds high-level meeting on evolving global science and regulatory challenges, hosted by AIFA
The International Coalition of Medicines Regulatory Authorities (ICMRA), a group of leading medicines regulatory authorities and experts from around the world, convened for a three-day meeting to discuss current and emerging challenges in science and global human medicine regulations. The annual ICMRA summit themed “Evolving science and regulatory challenges” was held in Rome, Italy, from 28 to 30 October 2019 and was hosted by the Italian Medicines Agency (AIFA)…

…Delegates from 28 different countries, representing more than 35 medicines regulatory authorities globally, as well as experts from the World Health Organization, the European Commission and the European Medicines Agency (EMA) engaged in productive discussions about medicines advances and regulation. How to build global reliance among regulators was the leitmotiv of this year’s summit. Many sessions were dedicated to sharing knowledge, experiences, lessons learned, and outcomes of actions undertaken to promote global cooperation and networking to better tackle common and global issues such as shortages and medicines availability, risk management, transparency.

“The rapidly changing scientific and technological environment is a challenge and an inspiration for us as regulatory authorities from across the world to shape the future of our strategic collaboration and develop common policies that bridge different national legislative frameworks and help us to use our resources and expertise most wisely.” said Guido Rasi, ICMRA Chair and Executive Director of the European Medicines Agency (EMA). “Building global reliance is one of the tools we are exploring to increase availability and accessibility of safe, efficient and high-quality medicinal products for patients worldwide.”

There was a general consensus that a robust consolidated global regulatory system is key for a common approach to major transformation in science and medicine. Digitalized healthcare and innovative designs of patient-centered clinical trials were some of the most important topics discussed during the second day of the meeting. In parallel, with presentations on different national experiences, regulators discussed how to collect and analyse big data and real world evidence to identify and seize upon potential opportunities for the use of innovative sources of data, as well as novel digital health devices and wearables.

Patient-centered and personalized medicine has also been widely discussed by the Heads of Agencies in a panel, because regenerative and advanced therapies represent revolutionary new source of highly personalized treatments with implications on health planning as well as legal and ethical aspects.

Varied experiences have been shared on the increased medical use of cannabis and the related regulatory level of evidence needed to secure safe, and appropriate access to cannabis derivatives as medicines.

Looking ahead
The ICMRA members also discussed the future strategic goals that can be achieved through the coalition: shortage prevention, strengthening of pharmacovigilance systems, supply chain integrity, promotion of biosimilars and of the responsible use of antibiotics to combat antimicrobial resistance were among the priorities debated in the last day of the ICMRA plenary.
As a unique global coalition ICMRA will continue to support international information sharing and crisis response and help to address current and emerging global human medicine regulatory and safety challenges in a transparent and authoritative manner.

 

 

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

 

 

IFFIm
http://www.iffim.org/library/news/press-releases/
29 October 2019
The Edge of Innovative Finance
A conversation with Christopher Egerton-Warburton.

 

IFRC [to 2 Nov 2019]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.

 

IVAC [to 2 Nov 2019]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
No new digest content identified.

 

IVI [to 2 Nov 2019]
http://www.ivi.int/
Selected IVI News & Announcements
IVI Awarded $4.5 Million Grant to Increase Accessibility of Oral Cholera Vaccine
October 28, 2019 – SEOUL, South Korea – The International Vaccine Institute (IVI) has received a $4.5 million grant from the Bill & Melinda Gates Foundation to simplify the current oral cholera vaccine (OCV) and further increase its accessibility.

To date, the Gates Foundation has invested $23 million in IVI’s Cholera Vaccine Program to develop the world’s first low-cost OCV, a safe and effective measure to prevent and control cholera worldwide. With this most recent award, IVI will explore modifications to the existing formula and optimize a single manufacturing process to give higher yields of vaccine and thus increase production capacity while lowering costs.

This reformulation of the OCV is the next chapter in IVI’s going on 20-year cholera vaccine story. With new available data on immune responses to antigens and the geographic distribution of certain cholera strains, IVI has taken the initiative to investigate the efficacy of a simplified formula, inactivated by a single method. IVI will continue to partner with EuBiologics, a Korean biopharmaceutical company and the world’s largest supplier of the low-cost OCV, to pursue the development of this next iteration of an accessible vaccine against the poverty-related disease.

“For a vaccine to be truly effective, it has to first be accessible. The current OCV developed by IVI and technology transferred to manufacturing partners made available a high-quality and easy-to-deliver protection against cholera in developing countries for the first time,” said Dr. Julia Lynch, Deputy Director General of Development & Delivery at IVI, and Program Director of IVI’s Cholera Vaccine Program. “With the new grant, now we can work on expanding that protection to more people at risk of the disease.”

IVI first initiated efforts to develop a safe, effective, and affordable cholera vaccine in the early 2000s, when the life-saving vaccine wasn’t readily available to the populations most at risk of epidemic and endemic cholera. Through partnerships and support from Sweden, Vietnam, India, and South Korea, IVI facilitated development and production of two affordable and WHO-prequalified OCVs, Shanchol and Euvichol / Euvichol-Plus. As of November 2018, over 36 million doses have been deployed from the WHO’s stockpile

 

JEE Alliance [to 2 Nov 2019]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 2 Nov 2019]
http://www.msf.org/
Latest [Selected Announcements]
Pakistan
Innovative TB trial starts in Sindh province
Press Release 31 Oct 2019
… The endTB trial is a phase III randomized controlled trial comparing five new treatment regimens against MDR-TB which contain two of the three new tuberculosis (TB) drugs developed in recent years, bedaquiline and delamanid, in combination with other existing oral TB drugs.
A related, parallel trial, called endTB-Q, will evaluate a sixth treatment combination and two different treatment durations, to be used against forms of MDR-TB which are also resistant to fluoroquinolones, a group of antibiotics used as so-called ‘second-line’ drugs in the treatment of TB…

Tuberculosis
Patients tackle arduous and lengthy tuberculosis treatment…
Project Update 30 Oct 2019

Access to medicines
MSF protests at TB conference against drug corporations keeping li…
Press Release 30 Oct 2019
:: Cure rates for deadly forms of drug-resistant TB remain low, as does the rate of people have access to the newest drugs, as prices remain high.
:: MSF demands Johnson&Johnson, Mylan, Otsuka and the TB Alliance to lower the price of their lifesaving medicines, often developed with public funds.
:: MSF also demands the corporations to improve transparency around research costs and licence their drugs to enable the production of generic versions.

 

National Vaccine Program Office – U.S. HHS [to 2 Nov 2019]
https://www.hhs.gov/vaccines/about/index.html
No new digest content identified.

 

NIH [to 2 Nov 2019]
http://www.nih.gov/news-events/news-releases
Selected News Releases
No new digest content identified.

 

PATH [to 2 Nov 2019]
https://www.path.org/media-center/
Selected Announcements
PATH collaborates with ASCENT to support patient-centered TB care
October 29, 2019 by PATH
PATH is embarking on a collaboration with ASCENT, a partnership led by KNCV Tuberculosis Foundation and funded and supported by Unitaid, to help patients in five countries in Asia, Africa, and Europe adhere to and successfully complete TB treatment using digital technology. PATH’s role is leading the implementation and evaluation of digital adherence technologies in Ukraine beginning in 2020. Our Market Dynamics team is collaborating with partners across the consortium to establish a global market for optimized products, price, and supply chain models…

 

Sabin Vaccine Institute [to 2 Nov 2019]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 2 Nov 2019]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
30 October 2019
Promoting gender equality in Brazil step by step

28 October 2019
Many prisoners are lacking basic HIV services

 

UNICEF [to 2 Nov 2019]
https://www.unicef.org/media/press-releases
Selected Statements, Press Releases, Reports
[No new digest content identified]

 

Vaccination Acceptance Research Network (VARN) [to 2 Nov 2019]
https://vaccineacceptance.org/news.html#header1-2r
No new digest content identified.

 

Vaccine Confidence Project [to 2 Nov 2019]
http://www.vaccineconfidence.org/
Confidence Commentary:
A Polio-Free Pakistan: The cure is persistence
Heidi Larson | 26 Oct, 2019
World Polio Day – Op-Ed published in The Daily Tines

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 2 Nov 2019]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 2 Nov 2019]
https://wellcome.ac.uk/news
Opinion | 28 October 2019
Talking about the ‘antibiotic apocalypse’ is alarming, not persuasive. This is why
Dan Metcalfe, Head of Campaigns Wellcome
How we talk publicly about an issue influences how likely people are to support or ignore it. With Reframing Resistance, we’re using global research to develop effective ways to communicate about drug-resistant infections to inspire change.

 

The Wistar Institute [to 2 Nov 2019]
https://www.wistar.org/news/press-releases
No new digest content identified.

 

World Organisation for Animal Health (OIE) [to 2 Nov 2019]
http://www.oie.int/en/for-the-media/press-releases/2019/
No new digest content identified.

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 2 Nov 2019]
https://alliancerm.org/press-releases/
October 31, 2019
The Alliance for Regenerative Medicine Outlines Recommendations for Increasing the Number of European-Based ATMP Clinical Trials
WASHINGTON, DC and BRUSSELS, BELGIUM
:: Europe has become less competitive than other regions in attracting new ATMP [advanced therapy medicinal products] clinical trials.
:: Faster and more streamlined review processes for clinical trials by regulatory authorities are fundamental to increase clinical research and development in Europe.
:: There is considerable country-to-country variability within Europe: the UK has the highest absolute number of new ATMP clinical trials, but relative to their size, Belgium, Denmark, and Switzerland outperform other European countries as well as the USA and Canada.

 

BIO [to 2 Nov 2019]
https://www.bio.org/insights/press-release
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 2 Nov 2019]
http://www.dcvmn.org/
No new digest content identified.

 

IFPMA [to 2 Nov 2019]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA Position paper – Assessment Reports as a Tool for Regulatory Reliance
28 October 2019
… We believe that public assessment reports are valuable as they provide key insights into the rationale of the regulatory decision-making process. Where available, these reports should be the primary source of information to support regulatory reliance….

 

PhRMA [to 2 Nov 2019]
http://www.phrma.org/
Selected Press Releases, Statements
No new digest content identified.

Journal Watch

Posted on by

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

Standing orders program of pneumococcal vaccination for hospitalized elderly patients in Hong Kong: A cost-effectiveness analysis

Posted on by

American Journal of Infection Control
November 2019 Volume 47, Issue 11, p1283-1404
http://www.ajicjournal.org/current

 

Major Articles
Standing orders program of pneumococcal vaccination for hospitalized elderly patients in Hong Kong: A cost-effectiveness analysis
Nianli Xing, Wing-yin Cheung, Minghuan Jiang, Joyce H.S. You
p1302–1308
Published online: June 29, 2019

Mass campaigns combining antimalarial drugs and anti-infective vaccines as seasonal interventions for malaria control, elimination and prevention of resurgence: a modelling study

Posted on by

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 2 Nov 2019)

 

Research article
Mass campaigns combining antimalarial drugs and anti-infective vaccines as seasonal interventions for malaria control, elimination and prevention of resurgence: a modelling study
The only licensed malaria vaccine, RTS,S/AS01, has been developed for morbidity-control in young children. The potential impact on transmission of deploying such anti-infective vaccines to wider age ranges, possibly with co-administration of antimalarial treatment, is unknown. Combinations of existing malaria interventions is becoming increasingly important as evidence mounts that progress on reducing malaria incidence is stalling and threatened by resistance.
Authors: Flavia Camponovo, Chris F. Ockenhouse, Cynthia Lee and Melissa A. Penny
Citation: BMC Infectious Diseases 2019 19:920
Published on: 29 October 2019

Pertussis hospitalizations among term and preterm infants: clinical course and vaccine effectiveness

Posted on by

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 2 Nov 2019)

 

Research article
Pertussis hospitalizations among term and preterm infants: clinical course and vaccine effectiveness
Pertussis causes severe disease in young unvaccinated infants, with preterms potentially at highest risk. We studied pertussis in hospitalized infants as related to gestational age (GA) and vaccination history.
Authors: Nicoline A. T. van der Maas, Elisabeth A. M. Sanders, Florens G. A. Versteegh, Albertine Baauw, Anneke Westerhof and Hester E. de Melker
Citation: BMC Infectious Diseases 2019 19:919
Published on: 29 October 2019

Key challenges for delivering clinical impact with artificial intelligence

Posted on by

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 2 Nov 2019)

 

Opinion
Key challenges for delivering clinical impact with artificial intelligence
Artificial intelligence (AI) research in healthcare is accelerating rapidly, with potential applications being demonstrated across various domains of medicine. However, there are currently limited examples of such techniques being successfully deployed into clinical practice. This article explores the main challenges and limitations of AI in healthcare, and considers the steps required to translate these potentially transformative technologies from research to clinical practice.
Authors: Christopher J. Kelly, Alan Karthikesalingam, Mustafa Suleyman, Greg Corrado and Dominic King
Citation: BMC Medicine 2019 17:195
Published on: 29 October 2019

Assessment of factors affecting vaccine cold chain management practice in public health institutions in east

Posted on by

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 2 Nov 2019)

 

Research article
Assessment of factors affecting vaccine cold chain management practice in public health institutions in east Gojam zone of Amhara region
Maintaining quality of vaccines is one of the main challenges of immunization programs in Ethiopia. The objective of this study is to assess the factor affecting vaccine cold chain management practice in immuniza…
Authors: Hewan Adam Bogale, Abebe Feyissa Amhare and Alemtsehay Adam Bogale
Citation: BMC Public Health 2019 19:1433
Published on: 1 November 2019

Effect of vaccine reminder and tracker bracelets on routine childhood immunization coverage and timeliness in urban Pakistan: protocol for a randomized controlled trial

Posted on by

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 2 Nov 2019)

 

Study protocol
Effect of vaccine reminder and tracker bracelets on routine childhood immunization coverage and timeliness in urban Pakistan: protocol for a randomized controlled trial
Inability to track children’s vaccination history coupled with parents’ lack of awareness of vaccination due dates compounds the problem of low immunization coverage and timeliness in developing countries. Tra…
Authors: Danya Arif Siddiqi, Mehr Munir, Mubarak Taighoon Shah, Aamir Javed Khan and Subhash Chandir
Citation: BMC Public Health 2019 19:1421
Published on: 30 October 2019

Implementation strategy and cost of Mozambique’s HPV vaccine demonstration project

Posted on by

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 2 Nov 2019)

 

Research article
Implementation strategy and cost of Mozambique’s HPV vaccine demonstration project
Cost is an important determinant of health program implementation. In this study, we conducted a comprehensive evaluation of the implementation strategy of Mozambique’s school-based HPV vaccine demonstration p…
Authors: Caroline Soi, Joseph B. Babigumira, Baltazar Chilundo, Vasco Muchanga, Luisa Matsinhe, Sarah Gimbel, Orvalho Augusto and Kenneth Sherr
Citation: BMC Public Health 2019 19:1406
Published on: 29 October 2019

Patient advocacy organizations’ information for patients on pre-approval access to investigational treatments

Posted on by

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 2 Nov 2019)

 

Research note
Patient advocacy organizations’ information for patients on pre-approval access to investigational treatments
To evaluate the availability of information regarding patient access to investigational treatments through clinical trials and non-trial pre-approval access pathways from a sample of patient advocacy organization (PAO) websites in the United States
Authors: Kelly McBride Folkers, Sarah Leone and Arthur Caplan
Citation: BMC Research Notes 2019 12:706
Published on: 28 October 2019

Measurement of coverage, compliance and determinants of uptake in a publicly funded rotavirus vaccination programme: a retrospective cohort study

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BMJ Open
November 2019 – Volume 9 – 11
http://bmjopen.bmj.com/content/current

 

 

Measurement of coverage, compliance and determinants of uptake in a publicly funded rotavirus vaccination programme: a retrospective cohort study (2 November, 2019)
Ellen Rafferty, Xiaoyan Guo, Bruce McDonald, Lawrence W Svenson, Shannon Elizabeth MacDonald

Determinants of vaccine hesitancy in Switzerland: study protocol of a mixed-methods national research programme

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BMJ Open
November 2019 – Volume 9 – 11
http://bmjopen.bmj.com/content/current

 

Contents
Determinants of vaccine hesitancy in Switzerland: study protocol of a mixed-methods national research programme (2 November, 2019)
Michael J. Deml, Kristen Jafflin, Sonja Merten, Benedikt Huber, Andrea Buhl, Eleonora Frau, Valérie Mettraux, Joanna Sonderegger, Paulina Kliem, Rachele Cattalani, Daniel Krüerke, Constanze Pfeiffer, Claudine Burton-Jeangros, Philip E. Tarr

 

Triangulation of measles vaccination data in the United Kingdom of Great Britain and Northern Ireland

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Bulletin of the World Health Organization
Volume 97, Number 11, November 2019, 729-788
https://www.who.int/bulletin/volumes/97/11/en/

 

Research
Triangulation of measles vaccination data in the United Kingdom of Great Britain and Northern Ireland
— Michael Edelstein, Joanne White, Antoaneta Bukasa, Vanessa Saliba & Mary Ramsay
http://dx.doi.org/10.2471/BLT.18.229138

Effect of armed conflict on vaccination: evidence from the Boko haram insurgency in northeastern Nigeria

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Conflict and Health
http://www.conflictandhealth.com/
[Accessed 2 Nov 2019]

 

Research
29 October 2019
Effect of armed conflict on vaccination: evidence from the Boko haram insurgency in northeastern Nigeria
Armed conflicts can have severe adverse effects on population health, both directly and indirectly, through the destruction of health care systems. This paper evaluates the causal effect of the Boko Haram insurgency in northeastern Nigeria on the vaccination rate.
Authors: Ryoko Sato

Clinical REsearch During Outbreaks (CREDO) Training for Low- and Middle-Income Countries [PDF – 576 KB – 4 pages]

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Emerging Infectious Diseases
Volume 25, Number 11—November 2019
http://wwwnc.cdc.gov/eid/

 

Dispatches
Clinical REsearch During Outbreaks (CREDO) Training for Low- and Middle-Income Countries [PDF – 576 KB – 4 pages]
N. Kayem et al.
We describe a pilot of the Clinical REsearch During Outbreaks (CREDO) initiative, a training curriculum for researchers in epidemic-prone low- and middle-income countries who may respond to disease outbreaks. Participants reported improved confidence in their ability to conduct such research and overall satisfaction with the course structure, content, and training.

HPV vaccination: Are we overlooking additional opportunities to control HPV infection and transmission?

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International Journal of Infectious Diseases
November 2019 Volume 88, p1-158
https://www.ijidonline.com/issue/S1201-9712(19)X0017-X

 

Perspective
HPV vaccination: Are we overlooking additional opportunities to control HPV infection and transmission?
Alex Vorsters, Pierre Van Damme, F. Xavier Bosch
p110–112
Published online: September 12, 2019