Author Archives: davidrcurry

Journal Watch

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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

A childhood immunization education program for parents delivered during late pregnancy and one-month postpartum: a randomized controlled trial

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BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content

 

Research article
A childhood immunization education program for parents delivered during late pregnancy and one-month postpartum: a randomized controlled trial
Improved immunization rates have reduced the incidence of vaccine-preventable diseases (VPDs) in advanced nations. Japan’s unique vaccination system classifies vaccines into routine vaccines ostensibly require…
Authors: Hiroko Otsuka-Ono, Narumi Hori, Hiroshi Ohta, Yukari Uemura and Kiyoko Kamibeppu
Citation: BMC Health Services Research 2019 19:798
Published on: 5 November 2019

Health professionals’ acceptance and willingness to pay for hepatitis B virus vaccination in Gondar City Administration governmental health institutions, Northwest Ethiopia

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BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content

 

Health professionals’ acceptance and willingness to pay for hepatitis B virus vaccination in Gondar City Administration governmental health institutions, Northwest Ethiopia
Hepatitis B virus (HBV) infection is a global public health problem. The burden of the disease is high in low and middle income countries like Ethiopia. However, for highly vulnerable groups such as health pro…
Authors: Siwule Abiye, Mezgebu Yitayal, Giziew Abere and Asefa Adimasu
Citation: BMC Health Services Research 2019 19:796
Content type: Research article
Published on: 5 November 2019

Mumps: MMR vaccination and genetic diversity of mumps virus, 2007–2011 in Catalonia, Spain

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BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 9 Nov 2019)

 

Research article
Mumps: MMR vaccination and genetic diversity of mumps virus, 2007–2011 in Catalonia, Spain
Mumps is a vaccine-preventable disease but outbreaks have been reported in persons vaccinated with two doses of MMR vaccine.
Authors: Irene Barrabeig, Andrés Antón, Núria Torner, Tomàs Pumarola, Josep Costa and Àngela Domínguez
Citation: BMC Infectious Diseases 2019 19:954
Content type: Research article
Published on: 9 November 2019

What do patients with unmet medical needs want? A qualitative study of patients’ views and experiences with expanded access to unapproved, investigational treatments in the Netherlands

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BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 9 Nov 2019)

 

What do patients with unmet medical needs want? A qualitative study of patients’ views and experiences with expanded access to unapproved, investigational treatments in the Netherlands
Patients with unmet medical needs sometimes resort to non-standard treatment options, including the use of unapproved, investigational drugs in the context of clinical trials, compassionate use or named-patient programs. The views and experiences of patients with unmet medical needs regarding unapproved, investigational drugs have not yet been examined empirically.
Authors: Eline M. Bunnik and Nikkie Aarts
Content type: Research article
9 November 2019
Open Access

mHealth communication to strengthen postnatal care in rural areas: a systematic review

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BMC Pregnancy and Childbirth
http://www.biomedcentral.com/bmcpregnancychildbirth/content
(Accessed 9 Nov 2019)

 

mHealth communication to strengthen postnatal care in rural areas: a systematic review
Postnatal care (PNC) in rural areas is characterised by low uptake, with possible effect on maternal and neonatal mortality rates. Mobile health (mHealth) communication has been proposed to promote the uptake …
Authors: Florence Mbuthia, Marianne Reid and Annali Fichardt
Citation: BMC Pregnancy and Childbirth 2019 19:406
Content type: Research article
Published on: 6 November 2019

Immunity to rubella: an Italian retrospective cohort study

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BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 9 Nov 2019)

 

Research article
Immunity to rubella: an Italian retrospective cohort study
International guidelines recommend that healthcare workers (HCWs) have presumptive evidence of immunity to rubella and that susceptible HCWs and doubt cases receive two doses of the MMR vaccine. However, a sma…
Authors: Francesco Paolo Bianchi, Sara De Nitto, Pasquale Stefanizzi, Angela Maria Vittoria Larocca, Cinzia Annatea Germinario and Silvio Tafuri
Citation: BMC Public Health 2019 19:1490
Content type: Research article
Published on: 8 November 2019

The fog of genetics: what is known, unknown and unknowable in the genetics of complex traits and diseases

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EMBO Reports
Volume 20 Issue 11 5 November 2019
https://www.embopress.org/toc/14693178/current

 

Opinion 21 October 2019
The fog of genetics: what is known, unknown and unknowable in the genetics of complex traits and diseases
João Pedro de Magalhães, Jingwei Wang
A major task for genetics is searching for genetic variants associated with disease. But we may well be missing a large number of “unknown unknown” alleles in the “fog of genetics”.

Preparing scientists for a visual future : Visualization is a powerful tool for research and communication but requires training and support

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EMBO Reports
Volume 20 Issue 11 5 November 2019
https://www.embopress.org/toc/14693178/current

 

Science & Society 14 October 2019
Preparing scientists for a visual future : Visualization is a powerful tool for research and communication but requires training and support
Shraddha Nayak. Janet H Iwasa
The increasing complexity of biological data along with the need to communicate results requires visualization. It requires more training and support though to help scientists create efficient visual representations of their work.

Knowing antimicrobial resistance in practice: a multi-country qualitative study with human and animal healthcare professionals

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Global Health Action
Volume 12, 2019 Supp 1
https://www.tandfonline.com/toc/zgha20/12/sup1?nav=tocList

 

Article
Knowing antimicrobial resistance in practice: a multi-country qualitative study with human and animal healthcare professionals
Maddy Pearson & Clare Chandler
Article: 1599560
Published online: 11 Jul 2019

A Professional Standard for Informed Consent for Stem Cell Therapies

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JAMA
November 5, 2019, Vol 322, No. 17, Pages 1625-1728
http://jama.jamanetwork.com/issue.aspx

 

Viewpoint
A Professional Standard for Informed Consent for Stem Cell Therapies
Jeremy Sugarman, MD, MPH, MA; Roger A. Barker, MRCP, PhD; R. Alta Charo, JD
JAMA. 2019;322(17):1651-1652. doi:10.1001/jama.2019.11290
This Viewpoint summarizes recommendations from an International Society for Stem Cell Research task force charged with developing professional standards of patient consent for stem cell–based interventions offered outside a clinical trial given the spread of unregulated stem cell clinics offering unproven therapies.

Government Role in Regulating Vaccine Misinformation on Social Media Platforms

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JAMA Pediatrics
November 2019, Vol 173, No. 11, Pages 1007-1115
http://archpedi.jamanetwork.com/issue.aspx

 

Viewpoint
Government Role in Regulating Vaccine Misinformation on Social Media Platforms
Y. Tony Yang, ScD, LLM, MPH; David A. Broniatowski, PhD; Dorit Rubinstein Reiss, PhD
JAMA Pediatr. 2019;173(11):1011-1012. doi:10.1001/jamapediatrics.2019.2838
This Viewpoint discusses the challenges of balancing free speech against harms caused by vaccine misinformation on social media platforms and what the government’s role could potentially be in combating misinformation.

Prevalence of Immunodeficiency in Children With Invasive Pneumococcal Disease in the Pneumococcal Vaccine EraA Systematic Review

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JAMA Pediatrics
November 2019, Vol 173, No. 11, Pages 1007-1115
http://archpedi.jamanetwork.com/issue.aspx

 

Review
Prevalence of Immunodeficiency in Children With Invasive Pneumococcal Disease in the Pneumococcal Vaccine EraA Systematic Review
Coen Butters, BMed, DCH; Linny Kimly Phuong, BPharm(Hons), MBBS, DCH, MPH; Theresa Cole, BM, MRCPCH, PhD, FRACP; et al.
JAMA Pediatr. 2019;173(11):1084-1094. doi:10.1001/jamapediatrics.2019.3203
This systematic review of 17 studies assesses risk of primary immunodeficiency in children presenting with invasive pneumococcal disease with no other predisposing condition.

Public Knowledge of Human Papillomavirus and Receipt of Vaccination Recommendations

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JAMA Pediatrics
November 2019, Vol 173, No. 11, Pages 1007-1115
http://archpedi.jamanetwork.com/issue.aspx

 

Research Letter
Public Knowledge of Human Papillomavirus and Receipt of Vaccination Recommendations
Ryan Suk, MS; Jane R. Montealegre, PhD; Gizem S. Nemutlu, PhD; et al.
JAMA Pediatr. 2019;173(11):1099-1102. doi:10.1001/jamapediatrics.2019.3105
This cross-sectional survey study assesses knowledge of human papillomavirus by age and sex.

Immunogenicity and Reactogenicity of 13-Valent Pneumococcal Conjugate Vaccine Among Infants, Toddlers, and Children in Western Burkina Faso: Results From a Clinical Trial of Alternative Immunization Schedules

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Journal of the Pediatric Infectious Diseases Society (JPIDS)
Volume 8, Issue 5, November 2019
https://academic.oup.com/jpids/issue

 

ORIGINAL ARTICLES
Immunogenicity and Reactogenicity of 13-Valent Pneumococcal Conjugate Vaccine Among Infants, Toddlers, and Children in Western Burkina Faso: Results From a Clinical Trial of Alternative Immunization Schedules
Jennifer C Moïsi, Seydou Yaro, Sita S Kroman, Clarisse Gouem, Dramane Bayane …
J Pediatric Infect Dis Soc, Volume 8, Issue 5, November 2019, Pages 422–432, https://doi.org/10.1093/jpids/piy075
PCV13 has a satisfactory reactogenicity and immunogenicity profile when administered to infants, toddlers, and children according to alternative immunization schedules in Burkina Faso.

ICPD at 25 years: time to expand the agenda

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The Lancet
Nov 09, 2019 Volume 394 Number 10210 p1685-1778, e35
https://www.thelancet.com/journals/lancet/issue/current

 

Editorial
ICPD at 25 years: time to expand the agenda
The Lancet
In September, 1994, 11 000 delegates from governments, the UN, non-governmental organisations, and media gathered in Cairo, Egypt, for the International Conference on Population and Development (ICPD). This event was transformative for the reproductive health and rights community. The global consensus that emerged in Cairo—manifested in the ICPD Programme of Action adopted by 179 countries—shifted the focus of the development agenda away from demographics towards sexual and reproductive health and wellbeing, individual rights, and gender equality. 25 years on, the community will reconvene in Nairobi, Kenya, on Nov 12–14, to review progress and accelerate the implementation of the ICPD Programme of Action…

Nature at 150: evidence in pursuit of truth

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Nature
Volume 575 Issue 7781, 7 November 2019
http://www.nature.com/nature/current_issue.html

 

Editorial | 06 November 2019
Nature at 150: evidence in pursuit of truth
A century and a half has seen momentous changes in science. But evidence and transparency are more important than ever before.
… In other respects, Nature now is just the same as it was at the start. We will continue in our mission to stand up for research, serve the global research community and communicate the results of science around the world. We will strive to hold to account those in positions of responsibility in research, policy and industry, and to continue to advocate for fewer unintended harmful consequences of research for people and the planet.
Research, science, knowledge, scholarship — however we might choose to characterize the marshalling of evidence in the pursuit of truth — the values we hold are more important than ever before.

Immunization: vital progress, unfinished agenda

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Nature
Volume 575 Issue 7781, 7 November 2019
http://www.nature.com/nature/current_issue.html

 

Review Article | 06 November 2019
Immunization: vital progress, unfinished agenda
An overview of the effects of vaccines on global morbidity and mortality, vaccine safety issues, and the hurdles involved in proceeding from vaccine discovery to successful implementation.
Peter Piot, Heidi J. Larson[…] & Beate Kampmann
Abstract
Vaccination against infectious diseases has changed the future of the human species, saving millions of lives every year, both children and adults, and providing major benefits to society as a whole. Here we show, however, that national and sub-national coverage of vaccination varies greatly and major unmet needs persist. Although scientific progress opens exciting perspectives in terms of new vaccines, the pathway from discovery to sustainable implementation can be long and difficult, from the financing, development and licensing to programme implementation and public acceptance. Immunization is one of the best investments in health and should remain a priority for research, industry, public health and society.

A new twenty-first century science for effective epidemic response

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Nature
Volume 575 Issue 7781, 7 November 2019
http://www.nature.com/nature/current_issue.html

 

Review Article | 06 November 2019
A new twenty-first century science for effective epidemic response
Juliet Bedford, Jeremy Farrar[…] & John Nkengasong
Abstract
With rapidly changing ecology, urbanization, climate change, increased travel and fragile public health systems, epidemics will become more frequent, more complex and harder to prevent and contain. Here we argue that our concept of epidemics must evolve from crisis response during discrete outbreaks to an integrated cycle of preparation, response and recovery. This is an opportunity to combine knowledge and skills from all over the world—especially at-risk and affected communities. Many disciplines need to be integrated, including not only epidemiology but also social sciences, research and development, diplomacy, logistics and crisis management. This requires a new approach to training tomorrow’s leaders in epidemic prevention and response.

PanelApp crowdsources expert knowledge to establish consensus diagnostic gene panels

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Nature Genetics
Volume 51 Issue 11, November 2019
https://www.nature.com/ng/volumes/51/issues/11

 

Comment | 01 November 2019
PanelApp crowdsources expert knowledge to establish consensus diagnostic gene panels
A fundamental problem in rare-disease diagnostics is the lack of consensus as to which genes have sufficient evidence to attribute causation. To address this issue, we have created PanelApp ( https://panelapp.genomicsengland.co.uk ), a publicly available knowledge base of curated virtual gene panels.
Antonio Rueda Martin, Eleanor Williams[…] & Ellen M. McDonagh

A framework for tiered informed consent for health genomic research in Africa

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Nature Genetics
Volume 51 Issue 11, November 2019
https://www.nature.com/ng/volumes/51/issues/11

 

Comment | 28 October 2019
A framework for tiered informed consent for health genomic research in Africa
A generic framework for providing participant information and implementing a tiered consent process for health genomic research in Africa can help to harness global health benefits from sharing and meta-analysis of African genomic data while simultaneously respecting and upholding the autonomy and individual choices of African research participants.
Victoria Nembaware, Katherine Johnston[…] & Nicki Tiffin

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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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.