BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 29 Aug 2020)

The burden of laboratory-confirmed pertussis in low- and middle-income countries since the inception of the Expanded Programme on Immunisation (EPI) in 1974: a systematic review and meta-analysis
An effective vaccine against Bordetella pertussis was introduced into the Expanded Programme on Immunisation (EPI) by WHO in 1974, leading to a substantial global reduction in pertussis morbidity and mortality. I…
Authors: Rudzani Muloiwa, Benjamin M. Kagina, Mark E. Engel and Gregory D. Hussey
Citation: BMC Medicine 2020 18:233
Content type: Research article
Published on: 28 August 2020

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 29 Aug 2020)

Impact of COVID-19 pandemic and the lockdown on invasive meningococcal disease
Few data are available on the association between SARS-CoV-2 and secondary bacterial infections. Such an association was described for flu and invasive meningococcal disease (IMD). We aimed exploring such a co…
Authors: Muhamed-Kheir Taha and Ala-Eddine Deghmane
Citation: BMC Research Notes 2020 13:399
Content type: Research note
Published on: 27 August 2020

The CRISPR Journal
Volume 3, Issue 4 / August 2020
https://www.liebertpub.com/toc/crispr/3/4

Editorial
In Times Like These, We All Need a Moment of Science
Rodolphe Barrangou
Published Online:24 Aug 2020 https://doi.org/10.1089/crispr.2020.29102.rba
… The monumental challenges that lie ahead of us can be solved by science—and science alone. The most promising solutions on the way with regard to diagnostics, therapeutics, and vaccines, all come from a tireless and committed science community, which transcends the pervasive skepticism and disturbing antiscience bias still on the rise. Without the scientific enterprise, there will be no vaccine, no effective therapy; without the medical and health care community, there will be no recovery nor reprieve.
Making an Impact
Despite such difficult times, there are opportunities to rise to the challenge and monitor in real time how the scientific community is doing…

The CRISPR Journal
Volume 3, Issue 4 / August 2020
https://www.liebertpub.com/toc/crispr/3/4

Perspectives Free
An Examination of Public Discourse on Human Gene Editing Using Natural Language Processing
Micah Musser
Pages:237–247
Published Online:24 August 2020
https://doi.org/10.1089/crispr.2020.0003
This research aims to explore the different ways in which scientists, ethicists, journalists, and commissions speak to the public about new gene-editing technologies. The research collected more than 100,000 sentences from books, news articles, and …

The European Journal of Public Health
Volume 30, Issue 4, August 2020
https://academic.oup.com/eurpub/issue/30/4

Editorials
Re-thinking health inequalities
Johan P Mackenbach
European Journal of Public Health, Volume 30, Issue 4, August 2020, Page 615, https://doi.org/10.1093/eurpub/ckaa001
Extract
The world we live in is hugely unequal, not only in terms of income and wealth, but also in terms of life-span and health. What makes it worse is that the two are correlated: people who have less material resources also tend to die younger and to have more health problems within their shorter lives. Wide-spread concern with these health inequalities has over the past decades led to an impressive stream of increasingly sophisticated research to find explanations. The growth in scientific understanding has also inspired confidence that we can…

The European Journal of Public Health
Volume 30, Issue 4, August 2020
https://academic.oup.com/eurpub/issue/30/4

Child and adolescent health
Factors associated with the uptake of the UK routine childhood immunization schedule in a bi-ethnic population
Gillian Santorelli, Jane West, Dan Mason, Chris Cartwright, Leena Inamdar …
European Journal of Public Health, Volume 30, Issue 4, August 2020, Pages 697–702, https://doi.org/10.1093/eurpub/ckaa069

Gates Open Research
https://gatesopenresearch.org/browse/articles
[Accessed 29 Aug 2020]

Study Protocol metrics AWAITING PEER REVIEW
Rejoice architecture meets social norms to accelerate vaccination in Nepal: Protocol for a mixed-method quasi-experimental study [version 1; peer review: awaiting peer review]
Alicia Paul, Kamana Upreti, Shraddha Nepal, Jeevan Lohani, Kriti Adhikari, Rajiv Rimal
Peer Reviewers Invited
Funder: Bill and Melinda Gates Foundation
PUBLISHED 26 Aug 2020

Global Public Health
Volume 15, 2020 Issue 9
http://www.tandfonline.com/toc/rgph20/current

Article
Governing COVID-19 without government in Brazil: Ignorance, neoliberal authoritarianism, and the collapse of public health leadership
Francisco Ortega & Michael Orsini
Pages: 1257-1277
Published online: 14 Jul 2020
ABSTRACT
Brazil’s governance of the COVID-19 pandemic has been described as nothing short of tragic by several commentators. President Jair Bolsonaro’s dangerous brew of neoliberal authoritarianism, science denialism and ableism has plunged this country into catastrophe. In this article we argue that this form (or lack) of public health governance can best be described as governance without (central) government. We begin with an overview of public health governance in the country before introducing the main theoretical concepts that guide our analysis, namely the notions of ‘government by exception’ and ‘strategic ignorance’. Finally, we sketch the main features of this emerging form of (non)governance of COVID-19. We highlight the new forms of solidarity and mutual aid that have emerged in favelas and Indigenous communities, which have stepped in to fill the void left by a limited federal presence. The article concludes by reflecting on what this collapse of public health reveals about the limitations of democratic governance in the age of Bolsonaro.

Human Gene Therapy
Volume 31, Issue 15-16 / August 2020
https://www.liebertpub.com/toc/hum/31/15-16

Research Articles
Gene Editing for Treatment and Prevention of Human Diseases: A Global Survey of Gene Editing-Related Researchers
Leonardo Fernandes Moutinho Rocha, Luiza Amara Maciel Braga, and Fabio Batista Mota
Pages:852–862
Published Online:27 July 2020
https://doi.org/10.1089/hum.2020.136
Abstract
In the next decades, gene editing technologies are expected to be used in the treatment and prevention of human diseases. Yet, the future uses of gene editing in medicine are still unknown, including its applicability and effectiveness to the treatment and prevention of infectious diseases, cancer, and monogenic and polygenic hereditary diseases. This study aims to address this gap by analyzing the views of over 1,000 gene editing-related researchers from all over the world. Some of our survey results show that, in the next 10 years, DNA double-strand breaks are expected to be the main method for gene editing, and CRISPR-Cas systems to be the mainstream programmable nuclease. In the same period, gene editing is expected to have more applicability and effectiveness to treat and prevent infectious diseases and cancer. Off-targeting mutations, reaching therapeutic levels of editing efficiency, difficulties in targeting specific tissues in vivo, and regulatory and ethical challenges are among the most relevant factors that might hamper the use of gene editing in humans. In conclusion, our results suggest that gene editing might become a reality to the treatment and prevention of a variety of human diseases in the coming 10 years. If the future confirms these researchers’ expectations, gene editing could change the way medicine, health systems, and public health deal with the treatment and prevention of human diseases.

International Health
Volume 12, Issue 5, September 2020
https://academic.oup.com/inthealth/issue/12/5

COMMENTARIES
The ethical case for global measles eradication—justice and the Rule of Rescue
David N Durrheim, Jon K Andrus
International Health, Volume 12, Issue 5, September 2020, Pages 375–377, https://doi.org/10.1093/inthealth/ihaa038

JAMA Network
COVID-19 Update August 29, 2020

These articles on COVID-19 were published across the JAMA Network in the last week.

JAMA
August 25, 2020, Vol 324, No. 8, Pages 725-816
https://jamanetwork.com/journals/jama/currentissue

Viewpoint
Attacks on Public Health Officials During COVID-19
Michelle M. Mello, JD, PhD; Jeremy A. Greene, MD, PhD; Joshua M. Sharfstein, MD
free access has active quiz
JAMA. 2020;324(8):741-742. doi:10.1001/jama.2020.14423
This Viewpoint discusses ongoing harassment and threats against US public health officials who propose or take steps to protect communities from coronavirus disease 2019 (COVID-19) and it proposes possible responses, including a call to elected leaders to implement protection of the officials from illegal harassment, assault, and violence.

The Lancet
Aug 29, 2020 Volume 396 Number 10251 p583-648, e21
https://www.thelancet.com/journals/lancet/issue/current

Editorial
Research and higher education in the time of COVID-19
The Lancet

New England Journal of Medicine
August 27, 2020 Vol. 383 No. 9
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Covid-19 and Immunity in Aging Populations — A New Research Agenda
Wayne C. Koff, Ph.D.,
and Michelle A. Williams, Sc.D.
The race is on throughout the world to develop Covid-19 vaccines and therapeutics and end a pandemic that threatens to infect a substantial portion of the planet’s population and perhaps kill millions of people, especially older adults. As billions of dollars flow into research and development efforts aimed at controlling the virus, the pandemic response remains hamstrung by our limited understanding of how to generate effective immunity, particularly in the elderly…

PLoS One
http://www.plosone.org/

Research Article
Incidence of intussusception before and after the introduction of rotavirus vaccine in Korea
Hye-Kyung Cho, Se Hwan Hwang, Hye Na Nam, Kyungdo Han, Bongsung Kim, Insik Kong, Kwangsuk Park, Jaeyoung Lee
Research Article | published 28 Aug 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0238185

PLoS One
http://www.plosone.org/

Willingness to participate in future HIV vaccine trials among men who have sex with men and female sex workers living in Nairobi, Kenya
Elizabeth Mueni Mutisya, Gaudensia Mutua, Delvin Nyasani, Hannah Nduta, Rhoda W. Kabuti, Vincent Muturi-Kioi, Gloria Omosa-Manyonyi, Andrew Abaasa, Krysia Lindan, Matt A. Price, Joshua Kimani, Aggrey Omu Anzala
Research Article | published 24 Aug 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0238028

Science
28 August 2020 Vol 369, Issue 6507
http://www.sciencemag.org/current.dtl

Editorial
The danger of DIY vaccines
By Arthur L. Caplan, Alison Bateman-House
Science28 Aug 2020 : 1035
Summary
The world needs to trust science if vaccines are to prove useful, particularly those being developed to combat coronavirus disease 2019 (COVID-19). That is what makes the recent appearance of highly visible “do-it-yourself” (DIY) vaccine research so morally troubling. It’s an obstacle to securing this trust.

Science
28 August 2020 Vol 369, Issue 6507
http://www.sciencemag.org/current.dtl

In Depth
In plasma OK, critics see politics, not science
By Kai Kupferschmidt, Jon Cohen
Science28 Aug 2020 : 1038-1039 Full Access
FDA’s emergency move raises fears of rushed approval for other experimental medicines.
Summary
Flanked at a Sunday evening press conference by Food and Drug Administration (FDA) Commissioner Stephen Hahn, President Donald Trump claimed convalescent plasma, which comes from people who have recovered from COVID-19, was “safe and very effective,” and had been “proven to reduce mortality by 35%”—what he called “a tremendous number.” But that number has received a tremendous amount of scrutiny. It surprised even the researchers who conducted the study, which has been posted as a preprint but has yet to be peer reviewed, on which Trump apparently based the declaration. Researchers’ best guess was that it reflected cherry picking of data from a small subset of the study—and that FDA’s emergency use authorization for the plasma, issued on the eve of the Republican National Convention, represented as much political theater as science. Critics worry the evidence has been overstated and there could be worrisome consequences for the evaluation of other experimental medicines.

Science
28 August 2020 Vol 369, Issue 6507
http://www.sciencemag.org/current.dtl

Policy Forum
Computational social science: Obstacles and opportunities
By David M. J. Lazer, Alex Pentland, Duncan J. Watts, Sinan Aral, Susan Athey, Noshir Contractor, Deen Freelon, Sandra Gonzalez-Bailon, Gary King, Helen Margetts, Alondra Nelson, Matthew J. Salganik, Markus Strohmaier, Alessandro Vespignani, Claudia Wagner
Science28 Aug 2020 : 1060-1062 Restricted Access
Data sharing, research ethics, and incentives must improve
Summary
The field of computational social science (CSS) has exploded in prominence over the past decade, with thousands of papers published using observational data, experimental designs, and large-scale simulations that were once unfeasible or unavailable to researchers. These studies have greatly improved our understanding of important phenomena, ranging from social inequality to the spread of infectious diseases. The institutions supporting CSS in the academy have also grown substantially, as evidenced by the proliferation of conferences, workshops, and summer schools across the globe, across disciplines, and across sources of data. But the field has also fallen short in important ways. Many institutional structures around the field—including research ethics, pedagogy, and data infrastructure—are still nascent. We suggest opportunities to address these issues, especially in improving the alignment between the organization of the 20th-century university and the intellectual requirements of the field.

Vaccine
Volume 38, Issue 40 Pages 6191-6346 (11 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/40

Discussion Full text access
Planning for COVID-19 vaccines safety surveillance
Sonali Kochhar, Daniel A. Salmon

Vaccine
Volume 38, Issue 40 Pages 6191-6346 (11 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/40

Review article Open access
A review of the costs of delivering maternal immunisation during pregnancy
Simon R Procter, Omar Salman, Clint Pecenka, Bronner P Gonçalves, … Mark Jit

Vaccine
Volume 38, Issue 40 Pages 6191-6346 (11 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/40

Research article Full text access
Prospective associations of regional social media messages with attitudes and actual vaccination: A big data and survey study of the influenza vaccine in the United States
Man-pui Sally Chan, Kathleen Hall Jamieson, Dolores Albarracin

Vaccine
Volume 38, Issue 40 Pages 6191-6346 (11 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/40

Research article Abstract only
Social-psychological determinants of maternal pertussis vaccination acceptance during pregnancy among women in the Netherlands
Charlotte Anraad, Birthe A. Lehmann, Olga Visser, Pepijn van Empelen, … Hilde M. van Keulen

Vaccine
Volume 38, Issue 40 Pages 6191-6346 (11 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/40

Research article Abstract only
Intussusception and Kawasaki disease after rotavirus vaccination in Taiwanese infants
Wan-Ting Huang, Yi-Chen Juan, Chia-Hung Liu, Yen-Yun Yang, K. Arnold Chan

Vaccine
Volume 38, Issue 40 Pages 6191-6346 (11 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/40

Research article Abstract only
Beliefs about causes of autism and vaccine hesitancy among parents of children with autism spectrum disorder
Robin P. Goin-Kochel, Eric Fombonne, Sarah S. Mire, Charles G. Minard, … Julie A. Boom

Vaccine
Volume 38, Issue 37 Pages 5877-5962 (18 August 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/37

Research Article
The effects of switching from 10 to 5-dose vials of MR vaccine on vaccination coverage and wastage: A mixed-method study in Zambia
Kirstin Krudwig, Barbara Knittel, Ali Karim, Natasha Kanagat, … Robert Steinglass
Highlights
:: Fear of vaccine wastage may lead to lower immunization coverage.
:: Mixed method study compared the use of 5-dose and 10-dose vials of measles-rubella.
: Districts using 5-dose MR saw increase coverage and reduced wastage.
: Health workers reported more willing to open a 5-dose MR vial.
: Switching to 5-dose MR vials can be accommodated within existing cold chain capacity and the wastage-adjusted cost differential per dose is negligible.

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 29 Aug 2020)

Open Access Article
Acceptance of COVID-19 Vaccination during the COVID-19 Pandemic in China
by Jiahao Wang , Rize Jing , Xiaozhen Lai , Haijun Zhang , Yun Lyu , Maria Deloria Knoll and Hai Fang
Vaccines 2020, 8(3), 482; https://doi.org/10.3390/vaccines8030482 – 27 Aug 2020
Abstract
Background: Faced with the coronavirus disease 2019 (COVID-19) pandemic, the development of COVID-19 vaccines has been progressing at an unprecedented rate. This study aimed to evaluate the acceptance of COVID-19 vaccination in China and give suggestions for vaccination strategies and immunization programs accordingly. Methods: In March 2020, an anonymous cross-sectional survey was conducted online among Chinese adults. The questionnaire collected socio-demographic characteristics, risk perception, the impact of COVID-19, attitudes, acceptance and attribute preferences of vaccines against COVID-19 during the pandemic. Multivariate logistic regression was performed to identify the influencing factors of vaccination acceptance. Results: Of the 2058 participants surveyed, 1879 (91.3%) stated that they would accept COVID-19 vaccination after the vaccine becomes available, among whom 980 (52.2%) wanted to get vaccinated as soon as possible, while others (47.8%) would delay the vaccination until the vaccine’s safety was confirmed. Participants preferred a routine immunization schedule (49.4%) to emergency vaccination (9.0%) or either of them (41.6%). Logistic regression showed that being male, being married, perceiving a high risk of infection, being vaccinated against influenza in the past season, believing in the efficacy of COVID-19 vaccination or valuing doctor’s recommendations could increase the probability of accepting COVID-19 vaccination as soon as possible, while having confirmed or suspected cases in local areas, valuing vaccination convenience or vaccine price in decision-making could hinder participants from immediate vaccination. Conclusion: During the pandemic period, a strong demand for and high acceptance of COVID-19 vaccination has been shown among the Chinese population, while concerns about vaccine safety may hinder the promotion of vaccine uptake. To expand vaccination coverage, immunization programs should be designed to remove barriers in terms of vaccine price and vaccination convenience, and health education and communication from authoritative sources are important ways to alleviate public concerns about vaccine safety.

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 29 Aug 2020
Ideas
I’m Optimistic That We Will Have a COVID-19 Vaccine Soon
But will everyone be able to get it?
6:00 AM ET
Alan Bernstein
Member of the Canadian COVID-19 Vaccine Task Force

BBC
http://www.bbc.co.uk/
Accessed 29 Aug 2020
Health
Coronavirus: Health workers’ army to be trained to deliver Covid vaccine
By Rachel Schraer Health reporter
The government plans to train up an army of health professionals to be ready to give the coronavirus vaccine, if and when one is shown to work.

The Economist
http://www.economist.com/
Accessed 29 Aug 2020
Science & technology
The coronavirus pandemic
Anti-covid-19 medicines are being approved too easily
And maybe for the wrong reasons
Aug 29th 2020
WHAT DO A malaria drug, a Russian vaccine and the blood plasma of people who have recovered from covid-19 have in common? All have been approved for use by governments in response to the coronavirus pandemic, with little or no scientific substance to back those decisions up…

A first-world problem
Conspiracy theories about covid-19 vaccines may prevent herd immunity
Anti-vaccination sentiments are more prevalent in rich countries than in poor ones

Financial Times
http://www.ft.com/home/uk
Accessed 29 Aug 2020
Moderna
US government’s Darpa probes Moderna’s vaccine patents
…The US Department of Defense’s research arm is probing patents filed by and awarded to Moderna, a US biotech company developing a Covid-19 vaccine, after researchers accused the company of failing to…
August 29, 2020

Coronavirus treatment
Covid-19 vaccine makers lobby EU for legal protection
…The European pharmaceutical industry’s vaccines lobby has pushed the EU for exemptions that would protect its members from lawsuits if there are problems with any new coronavirus vaccines, according to…
August 26, 2020

Forbes
http://www.forbes.com/
Accessed 29 Aug 2020
[No new, unique, relevant content]

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 29 Aug 2020
[No new, unique, relevant content]

Foreign Policy
http://foreignpolicy.com/
While You Weren’t Looking |
Africa Is Officially Polio-Free
The continent has largely eradicated wild polio, the crowning achievement of a massive, globally coordinated public health effort.
Amy Mackinnon

The Guardian
http://www.guardiannews.com/
[No new, unique, relevant content]

New Yorker
http://www.newyorker.com/
Accessed 29 Aug 2020
[No new, unique, relevant content]

New York Times
http://www.nytimes.com/
Accessed 29 Aug 2020
Asia Pacific
Sinovac’s Coronavirus Vaccine Candidate Approved for Emergency Use in China-Source
Sinovac Biotech Ltd’s coronavirus vaccine candidate CoronaVac was approved for emergency use as part of a programme in China to vaccinate high-risk groups such as medical staff, a person familiar with the matter said.
By Reuters Aug. 29

Americas
Sao Paulo to Provide Vaccine Even Without Federal Govt Help, Governor Says
The Brazilian state of Sao Paulo, which is in advanced trials of a Chinese coronavirus vaccine, will inoculate its population even if the federal government declines to help, governor Joao Doria told Reuters in an interview on Friday.
By Reuters Aug. 28

Europe
Exclusive: WHO Sweetens Terms to Join Struggling Global COVAX Vaccine Facility-Documents
Wealthier countries that join the World Health Organization’s COVID-19 vaccine plan are being offered a new option to pick and choose which shots they get while reserving a right to receive their “full share” of doses, documents seen by Reuters show.
By Reuters Aug. 28

Europe
UK to Allow Emergency Use of Any Effective COVID-19 Vaccine
Britain is preparing to revise its laws to allow the emergency use of any effective coronavirus vaccine before it is fully licensed — but only if the shots meet required safety and quality standards.
By The Associated Press Aug. 28

Olympics
Japan, Eyeing Olympics, Lines Up Half-Billion Doses of COVID-19 Vaccine
Japan is making an aggressive move to grab enough coronavirus vaccine to inoculate its population four times over, a push the government hopes will instil confidence that it can host a delayed Summer Olympics next year.
By Reuters Aug. 28

Europe
Russia, Expecting Plaudits for Vaccine, Is Miffed by Its Cool Reception
Russian officials and scientists dismiss warnings about safety as Western jealousy and sour grapes. But only 24 percent of Russian doctors would take the vaccine, one survey shows.
By Andrew E. Kramer

Americas
South American Presidents Agree to Team Up on COVID-19 Vaccine Knowledge and Access
A group of South America presidents agreed on Thursday to information sharing and coordination on access to eventual COVID-19 vaccines to counter the virus which has the continent within its grip, Chile’s foreign minister said.
By Reuters Aug. 28

Washington Post
https://www.washingtonpost.com/
Accessed 29 Aug 2020
Proposal to allow COVID vaccine exceptions dies in committee
By Associated Press
August 26, 2020 at 10:33 a.m. EDT
RICHMOND, Va. — A committee in Virginia’s legislature has halted legislation that would create exceptions for people who don’t want to get a COVID-19 vaccine.
The Roanoke Times reported Tuesday that the proposal was defeated in the House of Delegates’ Democratically controlled Health, Welfare and Institutions Committee.
Proposals from Republican Delegates Mark Cole and David LaRock would have created exceptions. The measure included exceptions for religious reasons as well as for people who don’t want to receive a mandated vaccine during a public health emergency.
One proposal also would have prevented the state health commissioner from requiring people to take vaccines during a public health epidemic.
Dr. Norman Oliver, Virginia’s health commissioner, caused a recent stir when he told WRIC that he would mandate COVID-19 vaccinations. Democratic Gov. Ralph Northam’s office said afterward that he did not plan for the state government to mandate vaccinations.
A federally approved vaccine currently does not exist. But researchers have been working to develop one.

Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 29 Aug 2020
Order from Chaos
The US cooperated with the Soviets on smallpox – it should do the same with China on COVID-19 vaccine distribution
James Haynes and Cheng Li
Thursday, August 27, 2020

Center for Global Development [to 29 Aug 2020]
http://www.cgdev.org/page/press-center
Accessed 29 Aug 2020
August 25, 2020
The COVID-19 Multi-model Comparison Collaboration Releases Its First Two Outputs
Since April 2020, a group of national governments, funders, and development partners supporting COVID-19 responses in low- and middle-income countries have been working together as the COVID-19 Multi-model Comparison Collaboration (CMCC) to support the use of epidemiological models during the COVID-19 pandemic. Today, the CMCC releases its first two outputs—an important step towards enhancing the informed use of models in COVID-related policymaking.
Kalipso Chalkidou et al.

Chatham House [to 29 Aug 2020]
https://www.chathamhouse.org/
[No new relevant content]

CSIS
https://www.csis.org/
Accessed 29 Aug 2020
Upcoming Event
Online Event: The Scramble for a Vaccine: Putin’s Sputnik V— “Trust me!”
September 2, 2020

Podcast Episode
Coronavirus Crisis Update: Can COVAX Change the Equation in the Scramble for Covid-19 Vaccines?
August 26, 2020 | By J. Stephen Morrison

Council on Foreign Relations
http://www.cfr.org/
Accessed 29 Aug 2020
Pharmaceuticals and Vaccines
What Is the World Doing to Create a COVID-19 Vaccine?
The search to find a vaccine for the new coronavirus is well underway. Governments and researchers are aiming to provide billions of people with immunity in eighteen months or less, which would be un…
Backgrounder by Claire Felter

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 29 Aug 2020
[No new relevant content]

Milestones :: Perspectives :: Research

Aligning Legislative, Spending Decisions with Climate Action Key to Recovering from COVID-19 Pandemic, Secretary-General Tells Speakers of Parliament
19 August 2020
SG/SM/20213
Following are UN Secretary-General António Guterres’ remarks at the opening of the Inter-Parliamentary Union (IPU) World Conference of Speakers of Parliament on the theme:  “Parliamentary leadership for more effective multilateralism that delivers peace and sustainable development for the people and planet”, in New York:
…First, of course, is the COVID-19 pandemic.  We face an unprecedented disaster, from economic wreckage to an education deficit imperiling an entire generation, from the aggravation of humanitarian crises to the deepening of already troubling infringements of human rights.  We have surpassed 21 million cases and 770,000 deaths — and the toll continues to grow and even accelerate in some places.
The United Nations family is working across many fronts to save lives, control transmission of the virus, ease the fallout and recover better.  We have shipped personal protective equipment and other medical supplies to more than 130 countries.  We continue to press for a global ceasefire and to fight the plague of misinformation.
Across the weeks, we have issued analysis and policy recommendations spanning the full range of affected countries, sectors, issues and populations.  From the beginning, the United Nations has been calling for massive global support for the most vulnerable people and countries — a rescue package amounting to at least 10 per cent of the global economy.  We are also supporting work to accelerate research and development for a people’s vaccine, affordable and accessible to all.
As we address the emergency today, we must learn its many lessons for tomorrow.  Even before the virus, our societies were on shaky footing, with rising inequalities, worsening degradation of the environment, shrinking civic space, inadequate public health and untenable social frictions rooted in governance failures and a lack of opportunities.
The pandemic has spotlighted these injustices in especially stark terms.  It has also exposed the world’s fragilities in general.  And so, we cannot go back to what was, but rather must turn the recovery into a real opportunity to do things right for the future…

Milestones :: Perspectives :: Research

WHO Emergencies Press Conference on coronavirus disease outbreak – 18 August 2020
Streamed live on Aug 18, 2020 https://www.youtube.com/watch?v=OWTnMdwUkDw
[Excerpts]
…00:09:24 [DG – Tedros Adhanom Ghebreyesus]
Sharing finite supplies strategically and globally is actually in each country’s national interest. No-one is safe until everyone is safe. No one country has access to research and development, manufacturing and all the supply chain for all essential medicines and materials and if we can work together we can ensure that all essential workers are protected and proven treatments like dexamethasone are available to those who need them.

With PPE and tests a collaboration between the public andprivate sectors meant supply was increased in order to support fair and equitable use of scarce products.

As new diagnostics, medicines and vaccines come through the pipeline it’s critical that countries don’t repeat the same mistakes. We need to prevent vaccine nationalism and for this reason WHO is working with governments and the private sector to both accelerate the science through the ACT accelerator and ensure that new innovations are available to everyone everywhere, starting with those at highest risk.

00:10:57
Since May WHO has been in extensive consultations to develop a new framework to guide fair and equitable access to diagnostics, therapeutics and vaccines for COVID-19 across all countries. These cross-cutting principles are key to the promotion of equitable access and fair allocation of these essential health products for the greatest impact globally.

For example once a successful vaccine has been identified WHO’s strategic advisory group will provide recommendations for their [sic] appropriate and fair use. The allocation of vaccines is proposed to be rolled out in two phases. In phase one dose will be allocated proportionally to all participating countries simultaneously to reduce overall risk. In phase two consideration will be given to countries in relation to threat and vulnerability. Front-line workers in health and social care settings are prioritised as they are essential to treat and protect the population and come in close contact with high mortality-risk groups.

Initial data has shown that adults over 65 years old and those with certain comorbidities are at the highest risk of dying from COVID-19. For most countries a phase-one allocation that builds
up to 20% of the population would cover most of the at-risk groups.

00:12:50
If we don’t protect these highest-risk people from the virus everywhere and at the same time we can’t stabilise health systems and rebuild the global economy… This is what the first crucial phase of the vaccine allocation mechanism aims to do.

We are all so interconnected. As a small example vaccine developed in one country may need to be filled in vials with stoppers that are produced in another using materials for the high-grade glass that are only available from yet another country.

We will need to quickly manufacture billions of doses to reach all those who need the vaccine, which means hundreds of millions of glass vials and ways to transport them effectively. All this means elite planning at the highest level is needed right now to prepare to vaccinate and treat the world as new technologies come down the pipeline.

00:14:09
As we accelerate the science solidarity is needed to provide a joint solution to the pandemic. The COVAX global vaccines facility is the critical mechanism for joint procurement and pooling risk across multiple vaccines, which is why today I sent a letter to every member state encouraging them to join the COVAX facility.

Like an orchestra we need all instruments to be played in harmony to create music that everyone enjoys. One or two instruments playing by themselves just wouldn’t suffice when the
world is waiting and listening intently.

We will work to bring the band together, to promote science, solutions and solidarity because we believe to our core that we do it best when we do it together. I thank you…

EMERGENCIES

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

Editor’s Note:
The most recent COVID-19 Situation Report posted is dated 16 August 2020. These daily reports seem to have been replaced with Weekly Epidemiological Updates, the first issue of which is dated 17 August 2020 as just below.

Weekly Epidemiological Update – 1
Coronavirus disease 2019 (COVID-19)
17 August 2020

Confirmed cases :: 22 812 491 [week ago: 21 026 758]
Confirmed deaths :: 795 132 [week ago: 755 786]

Key weekly updates
:: “There are two essential elements to addressing the pandemic effectively: leaders must step up to take action and citizens need to embrace new measures…My message is crystal clear: suppress, suppress, suppress the virus.”
WHO Director-General Dr Tedros, at his regular media briefing on Monday, 10 August

:: The Access to COVID-19 Tools (ACT) Accelerator, is a global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. Nine vaccine candidates are currently in the portfolio of the vaccines pillar (called COVAX) and going through phase two or phase three trials. This portfolio, already the broadest in the world, is constantly expanding. The ACT-Accelerator is the only up-and-running global initiative that brings together all the global research and development, manufacturing, regulatory, purchasing and procurement needed for all the tools required to end the pandemic.

:: Access to basic handwashing facilities is a key condition for schools to be able to operate safely in the midst of the COVID-19 pandemic. Yet the latest data from the WHO/UNICEF Joint Monitoring Programme (JMP) found that 43% of schools worldwide lacked access to basic handwashing with soap and water in 2019. UNICEF and partners have published a Framework for Reopening schools and guidance on hand hygiene, which compliments Key Messages and Actions for COVID-19 Prevention and Control in Schools and Considerations for school-related public health measures in the context of COVID-19.

:: WHO has published updated guidance on home care for patients with suspected or confirmed COVID-19 and the management of their contacts. The document provides guidance on the issues to be considered when deciding whether or not to provide care for COVID-19 patients at home and offers advice for health workers and caregivers providing that care.

:: WHO has published the Emergency Global Supply Chain System (COVID-19) catalogue, which lists all medical devices, including personal protective equipment, medical equipment, medical consumables, single use devices, laboratory and test-related devices that may be requested through the COVID-19 Supply Portal.

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

COVID-19 Vaccines – Discovery/Trials

Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19
August 20, 2020
:: In a Phase 1 study in the U.S., at 7 days after a second dose of 30μg, BNT162b2 elicited SARS-CoV-2–neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in younger and older adults.

:: The companies previously announced that BNT162b2-vaccinated human participants displayed a favorable breadth of epitopes recognized in T cell responses specific to the SARS-CoV-2 spike antigen, and that BNT162b2 demonstrated concurrent induction of high magnitude CD4+ and CD8+ T cell responses against the receptor binding domain (RBD) and against the remainder of the spike glycoprotein

:: Across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants

:: These results informed the selection of the BNT162b2 candidate for the pivotal Phase 2/3 global study in up to 30,000 participants that started in July 2020, which has to date enrolled more than 11,000 participants, including in areas with significant SARS-CoV-2 transmission

:: Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review of BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021

…The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials. We are proud to share our findings with the scientific community as we continue our work to deliver a safe and effective vaccine to combat this devastating virus,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We are especially pleased to offer these early data showing our vaccine candidate’s promising safety and immunogenicity profile from the U.S. trial and we look forward to sharing T cell immune response data from the German trial in the near future.”

“It is important to us to continue sharing data and related information on our COVID-19 vaccine lead candidate,” said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “The favorable safety profile of BNT162b2 and the breadth of T cell responses we previously announced have supported our decision to select this candidate for the pivotal Phase 2/3 study. As of today, we have already dosed more than 11,000 participants with BNT162b2 in that study.”…

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

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 19 August 2020
:: A cVDPV1 outbreak has been detected in Yemen. WHO and UNICEF are supporting local health authorities to plan and launch an effective outbreak response to limit virus spread.
:: Next week the African Regional Certification Committee is anticipated to announce that the African Region has met the required standard to be certified as wild polio free. To mark the occasion, a live stream to the virtual ceremony will be publicly accessible via WHO channels and a dedicated website.
:: The 18th report of the Independent Monitoring Board has been published on the GPEI website. The report presents an analysis of the current status of eradication efforts and makes recommendations to help accelerate progress toward interruption of wild poliovirus and the absence of all circulating vaccine-derived polioviruses (cVDPVs). The GPEI welcomes the IMB’s recommendations, scrutiny and shared commitment to polio eradication, and will continue to work closely with the IMB, polio-affected countries and partners to optimize the polio. [See excerpts below]
:: Dr Ana Elena Chevez has dedicated over twenty years of her life to protecting children from vaccine preventable diseases. In the latest story in our ‘Women Leaders’ series, she shares advice for the next generation of women leaders.

Summary of new WPV and cVDPV viruses this week (AFP cases and environmental samples):
:: Afghanistan: three WPV1 cases, one WPV1 positive environmental sample and five cVDPV2 positive environmental samples
:: Pakistan: two WPV1 cases, two WPV1 positive environmental samples and two cVDPV2 positive environmental samples
:: Cote d’Ivoire: four cVDPV2 cases
:: Nigeria: one cVDPV2 case
:: Somalia: two cVDPV2 cases and four cVDPV2 positive environmental samples
:: Sudan: two cVDPV2 cases
:: Yemen: 15 cVDPV1 cases

::::::

18th report of the Independent Monitoring Board
THE NEW NORMAL. FINDING THE PATH BACK TO ERADICATION IN THE TIME OF CORONAVIRUS
July 2020 :: 60 pages
INTRODUCTION. [excerpts]
…It is essential that the Polio Programme remembers that, by the end of 2019, it stood on very shaky ground. There were massive challenges both in interrupting wild poliovirus transmission in the endemic areas and in managing many vaccine-derived poliovirus outbreaks.

Cases of poliovirus had increased fivefold between 2018 and 2019. There was uncertainty and doubt surrounding the effectiveness of strategies and tools.

At the Polio Oversight Board meeting, that immediately followed the Abu Dhabi Pledging Conference, on 20 November 2019, donor countries made an unprecedented demand that the GPEI should review and reform its governance and accountability structures. This did not reflect a reduced determination by these donors to get the job done, but rather the depth of their concern that there was no clear end in sight for polio eradication, and a lack of clear accountability in a $1 billion a year spending programme.

Even before COVID-19, many donor countries’ overseas aid budgets were being heavily scrutinised. With the coronavirus’s savage impact on national economies, the case that polio dollars are safe in GPEI hands will, in future, need to be more convincingly made to the governments and taxpayers of these countries. At the same time, there is greater need for resources than originally planned.

Each year of failure to eradicate polio results in enormous health, opportunity, and economic costs. The budgetary needs of the programme are increasing steeply. They will increase further if vaccine-derived poliovirus outbreaks continue to occur on a wide scale. Also, conducting polio campaigns in a COVID-19 environment will be much slower, will need many more precautions (such as personal protective equipment), and, as a result, will be more expensive.

…Overall, since late February and early March 2020, more than 60 polio vaccination campaigns, of different geographical scales, have been paused in 38 countries. Six million doses of vaccine had been delivered to those countries. They could not be used. Another 100 million doses have been procured, but still await shipment because of air freight disruption. Some of these vaccines have been delivered, in the weeks running up to vaccination campaigns that were resumed in July 2020. However, other batches of vaccines will be nearing the end of their shelf life and the Polio Programme will have to bear the costs of the waste and resupply. Also, some of the suppliers are reaching storage capacity and may well be forced to stop production, and there may be longer-term implications for manufacturers…

The Polio Programme is now poised for resumption when vaccine rounds can be planned and start again. The GPEI has set up a new committee to oversee this process, to be called the GPEI Continuity Planning and Facilitation Group (PFG). Its objectives include:
:: To facilitate development and tracking of a comprehensive global level GPEI workplan, in support of regional and country polio eradication activities, to adjust to the COVID-19 pandemic;
:: To identify any long-term strategic adjustments to the Polio Endgame Strategy 2019–2023 that may be required in the post-emergency phase of the COVID-19 pandemic in order to ensure sustainable, effective programme operations…

CONCLUSIONS. [excerpts]
It remains deeply inspiring to have a global vision of a world free of polio. It is a noble cause. It is important to many dedicated individuals currently working in the Polio Programme, and to others who have given a major part of their professional careers to the endeavour. It is a solemn reminder of front-line workers who lost their lives, and those who still do, to blind hatred for their personification of a humanitarian ideal. Ultimately, it will be a public good for all people of the world.

That vision currently seems a distant pinpoint of light. The Polio Programme is in dire straits. With a worsening epidemiological position, during 2019, for both wild and vaccine-derived poliovirus cases, the world was hit by a devastating pandemic of coronavirus. A yawning funding gap is opening up.

The Polio Programme stands in the middle of 2020 confronted by twin challenges that stand in the way of eradication. The first is the challenge of facing up to the real reasons that it went off track in 2019 into a jaw-dropping slump of performance at a time that the “almost there” narrative was believed by too many people. The phrase now being used to encourage everyone is: “The last mile is always the most difficult”. The Polio Programme is too forgiving of itself.

The second is the challenge of making the right choice of paths, emerging from the coronavirus crisis. An oft-repeated phrase at the IMB meeting was that the COVID-19 pandemic has a “silver lining” for the polio eradication programme. What that meant to those at the meeting who referred to it, or what it should mean for everyone involved in the future delivery is less clear.

What is overwhelmingly clear, though, for the Polio Programme at country level, at regional level, and at global level is that to “keep calm and carry on” through this complex situation would be inexcusable.

The criticality of developments over the next several months for polio eradication cannot be overstated. The opportunity of COVID-19 to finally determine innovative and integrated delivery strategies provides a lifeline for polio eradication. The risk of a Polio Programme going back into the field tired and half-hearted about needing new ideas could be the death knell of the programme. The GPEI Strategy Committee, in particular, needs to understand the gravity of the times and treat them as such..

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

Emergencies

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

Last WHO Situation Report published 23 June 2020

::::::

WHO Director-General’s opening remarks at the media briefing on COVID-19
21 August 2020
…I would like to begin today’s briefing with an update on the Ebola outbreak in the Equateur province of the Democratic Republic of the Congo.
The outbreak continues to increase and to spread geographically. Yesterday, the 100th case was reported, with 43 deaths in 11 health zones across the province.
There is currently a delay of about 5 days from the onset of symptoms to when an alert about a suspected case is raised.
This is concerning, because the longer a patient goes without treatment, the lower their chances of survival, and the longer the virus can spread unseen in communities.
The situation has been further complicated by a strike by health workers, which is affecting activities including vaccination and safe burials.
DRC has the best-trained workforce in the world for Ebola. This situation needs to be resolved as quickly as possible.
WHO and our partners are working intensively in communities to find cases and shorten the delay.
We’re also supporting the government of DRC to take a stronger role in the response, and to prepare areas that have not been affected so far.
There continues to be an urgent need for increased human resources and logistics capacity to support an effective response across an ever-expanding geographical area, and to help health officials identify cases earlier.
The government of DRC has developed a plan that needs about US$40 million. We urge partners to support this plan…

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

WHO Grade 3 Emergencies [to 22 Aug 2020]

Democratic Republic of the Congo – No new digest announcements identified
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 22 Aug 2020]
Iraq
:: WHO concludes COVID-19 awareness-raising campaign in the south 19 August 2020

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

::::::

WHO Grade 1 Emergencies [to 22 Aug 2020]

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

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

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
:: Recent Developments in Northwest Syria – Situation Report No. 19 – As of 21 August 2020
:: Syrian Arab Republic: COVID-19 Response Update No. 09 – 21 August 2020

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.
COVID-19 – No new digest announcements identified
East Africa Locust Infestation – No new digest announcements identified

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

WHO & Regional Offices [to 22 Aug 2020]

19 August 2020 News release
World Humanitarian Day 2020: A tribute to aid workers on the front lines
:: Amid a global pandemic, unprecedented needs and growing insecurity, aid workers and health-care responders are staying and delivering to the world’s most vulnerable people.
:: Last year was the most violent on record for humanitarians, with 483 attacked, 125 killed, 234 wounded and 124 kidnapped. The UN condemns all attacks on humanitarians.
:: OCHA and partners present the inspiring stories of humanitarian #RealLifeHeroes who are stepping up to meet the challenges.

::::::

Weekly Epidemiological Record, 21 August 2020, vol. 95, 34 (pp. 393–408)
Global yellow fever update, 2019
::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Zambia’s COVID-19 home-based care relieves health facilities 20 August 2020

WHO Region of the Americas PAHO
No new digest content identified

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

WHO European Region EURO
:: WHO-trained young epidemiologists help fight COVID-19 in the Republic of Moldova 20-08-2020
:: Risk of #COVID19 resurgence is never far away, but now we know how to target the virus instead of targeting society 20-08-2020
:: Against the backdrop of a humanitarian crisis, COVID-19 responders carry out heroic work in northwest Syria 19-08-2020
:: Tailoring health interventions: behavioural and cultural insights for health 19-08-2020
:: COVID-19 and conflict, a double battle for humanitarian workers 19-08-2020

WHO Eastern Mediterranean Region EMRO
:: Exceptional bravery of Beirut health care workers following blast 19 August 2020

WHO Western Pacific Region
:: Virtual press conference on COVID-19 in the Western Pacific Remarks by Dr Takeshi Kasai
18 August 2020

CDC/ACIP [to 22 Aug 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases
CDC data show disproportionate COVID-19 impact in American Indian/Alaska Native populations
Wednesday, August 19, 2020
The Centers for Disease Control and Prevention (CDC) released a new study that specifically examines how COVID-19 is affecting American Indians and Alaska Natives (AI/AN) – one of the racial and ethnic minority groups at highest risk from the disease. CDC found that in 23 selected states, the cumulative incidence of laboratory-confirmed COVID-19 cases among AI/AN was 3.5 times that of non-Hispanic whites.

These data also showed that AI/AN who tested positive for SARS-CoV-2 tended to be younger than white non-Hispanic individuals with COVID-19 infection. Compared to whites, a higher percentage of cases among AI/AN individuals were in people under 18 years of age (12.9 percent AI/AN; 4.3 percent white), and a smaller percentage of cases were among AI/AN 65 years or older (12.6 percent AI/AN; 28.6 percent white). Limited data were available to quantify the disparity in COVID-19 incidence, COVID-19 disease severity, and outcomes among AI/AN persons compared with those among other racial/ethnic groups, reinforcing the need to prioritize improved data collection as a key strategy to understand and improve health outcomes.

Recent CDC studies have shown that AI/AN are among the racial and ethnic minority groups at higher risk for severe COVID-19 outcomes. Persisting racial inequity and historical trauma have contributed to disparities in health and socioeconomic factors between AI/AN and white populations that have adversely affected tribal communities. The elevated incidence within this population might also reflect differences in reliance on shared transportation, limited access to running water, household size, and other factors that might facilitate community transmission…

MMWR News Synopsis Friday, August 21, 2020
National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13-17 Years – United States, 2019

Disparities in Incidence of COVID-19 Among Underrepresented Racial/Ethnic Groups in Counties Identified as Hotspots During June 5–18, 2020 — 22 States, February–June 2020

Trends in Number and Distribution of COVID-19 Hotspot Counties — United States, March 8–July 15, 2020

Racial and Ethnic Disparities Among COVID-19 Cases in Workplace Outbreaks by Industry Sector — Utah, March 6–June 5, 2020

Mass Testing for SARS-CoV-2 in 16 Prisons and Jails — Six Jurisdictions, United States, April–May 2020

Africa CDC [to 22 Aug 2020]
http://www.africacdc.org/
News
No new digest content identified.

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

National Health Commission of the People’s Republic of China
http://en.nhc.gov.cn/
News
Aug 22: Daily briefing on novel coronavirus cases in China
On Aug 21, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 22 new cases of confirmed infections.

Mask no longer mandatory for outdoor activities in Beijing
2020-08-21

China capable of containing COVID-19 resurgence in autumn, winter: expert
China is confident of being able to control a COVID-19 epidemic resurgence in autumn and winter based on recent epidemic containment experience over more than six months, a health expert said on Aug 19.

Announcements

Paul G. Allen Frontiers Group [to 22 Aug 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
News from The Paul G. Allen Frontiers Group: August 2020
August 20, 2020
Highlights include: Testing treatments aimed at Alzheimer’s for Covid-19 patients, how funding basic neuroscience research can support Covid-19 research, a new study by AHA-Allen Initiative awardee Tony Wyss-Coray, and more.

BARDA – U.S. Department of HHS [to 22 Aug 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

BMGF – Gates Foundation [to 22 Aug 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.

Bill & Melinda Gates Medical Research Institute [to 22 Aug 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

CARB-X [to 22 Aug 2020]
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.
No new digest content identified.

CEPI – Coalition for Epidemic Preparedness Innovations [to 22 Aug 2020]
http://cepi.net/
Latest News
COVAX seeks civil society representatives to contribute to ensuring equitable global access to COVID-19 vaccines
17 Aug 2020
CEPI, Gavi and the World Health Organization (WHO) are seeking representatives from civil society and community organisations (CSOs) to participate in COVAX – the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator – which aims to develop, manufacture and fairly allocate 2 billion doses of safe and effective COVID-19 vaccine by the end of 2021 to end the acute phase of the COVID-19 pandemic.
CSOs will play a vital role in the development and implementation of the COVAX initiative as well as the deployment of any successful vaccine through COVAX.
Specifically, we are looking for CSO representatives to participate in coordination meetings and a number of specific workstreams of COVAX. We anticipate that the roles of CSOs will include fostering the necessary support at a political and community engagement level to ensure equitable access and delivery of future COVID-19 vaccine; providing in-depth subject matter expertise in one or more areas including vaccine R&D, manufacturing, delivery, demand, access and allocation, policy, governance; and, acting as an advocate for civil society and community perspectives as appropriate. We also seek representatives’ input in building public trust and capacity across healthcare systems for COVID-19 vaccination programmes.
In addition to nominated representatives, broader CSOs will also be engaged in COVAX through other forums.’
The deadline for applications is 25 August, 2020.

EDCTP [to 22 Aug 2020]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
19 August 2020
Sir Alimuddin Zumla receives 2020 Mahathir Science Award
On 18 August 2020, the Mahathir Science Award Foundation and the Academy of Sciences Malaysia announced that Professor Sir Alimuddin Zumla is the recipient of the 2020 Mahathir Science Award. It is the most prestigious international science award for tropical sciences. Sir Alimuddin is Professor of Infectious Diseases and International Health at University College London, and a Consultant Infectious Diseases Physician at the UCL Hospitals NHS Foundation Trust in London, the United Kingdom. The Mahathir Science Award comprises a gold medal, a certificate and $100,000…

Emory Vaccine Center [to 22 Aug 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Medicines Agency [to 22 Aug 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
No new digest content identified.

European Vaccine Initiative [to 22 Aug 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

FDA [to 22 Aug 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
August 21, 2020 – Coronavirus (COVID-19) Update: Daily Roundup August 21, 2020

August 20, 2020 – Coronavirus (COVID-19) Update: Daily Roundup August 20, 2020

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

August 18, 2020 – Coronavirus (COVID-19) Update: Daily Roundup August 18, 2020

August 17, 2020 – Coronavirus (COVID-19) Update: Daily Roundup August 17, 2020

Fondation Merieux [to 22 Aug 2020]
http://www.fondation-merieux.org/
News, Events
Project
SEALAB project kicks off in Cambodia to strengthen laboratory systems in Southeast Asia
August 18, 2020 – Cambodia
SEALAB, a project launched to strengthen laboratory networks in Southeast Asia with funding from the Australian Department of Foreign Affairs and Trade (DFAT), was initiated in Cambodia during the first steering committee meeting held on August 7, 2020 in Phnom Penh.

Gavi [to 22 Aug 2020]
https://www.gavi.org/
News releases
No new digest content identified.

GHIT Fund [to 22 Aug 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.

Global Fund [to 22 Aug 2020]
https://www.theglobalfund.org/en/news/
News/Updates
No new digest content identified.

Hilleman Laboratories [to 22 Aug 2020]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 22 Aug 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Release
No new digest content identified.

IAVI [to 22 Aug 2020]
https://www.iavi.org/newsroom
No new digest content identified.

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

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

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

IFRC [to 22 Aug 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
World Humanitarian Day: One million masks produced by Syrian and Turkish volunteers, uniting forces against COVID-19
Ankara, Turkey (19 August 2020): Syrian refugees and Turkish people are coming together to help tackle the COVID-19 pandemic in Turkey and around the world. Since the pandemic began, over 120 volunteers and community members across Turkey have mobilize …
19 August 2020

Asia Pacific, Indonesia, Timor-Leste
Timor-Leste COVID-19 threats: Red Cross prioritizes border areas
Dili, Timor-Leste, August 17, 2020 – Timor-Leste Red Cross (CVTL) is urgently ramping up COVID-19 prevention in remote areas bordering Indonesia as the country’s containment success is threatened after its first new case has been reported in more than …
17 August 2020
Lebanon

IRC International Rescue Committee [to 22 Aug 2020]
http://www.rescue.org/press-release-index
Media highlights
Press Release
NE Syria: 60% increase in COVID-19 cases in past week, IRC calls for increased health capacity
August 17, 2020

IVAC [to 22 Aug 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
No new digest content identified.

IVI [to 22 Aug 2020]
http://www.ivi.int/
Selected IVI News & Announcements
IVI welcomes Finland as 36th member state with flag-raising ceremony
August 10, 2020 – SEOUL, South Korea – The flag of Finland was raised at the International Vaccin e Institute (IVI) Headquarters today during a ceremony welcoming the country’s accession to IVI. Finland joined the Seoul-based international organization dedicated to vaccines for global health in response to the COVID-19 pandemic, committing an annual contribution of 500,000 EUR during the period of 2020 – 2025 to support IVI’s core operations and 500,000 EUR for COVID-19 vaccine research and development this year…

JEE Alliance [to 22 Aug 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

MSF/Médecins Sans Frontières [to 22 Aug 2020]
http://www.msf.org/
Latest [Selected Announcements]
Greece
MSF statement on violent 20 August protest in Moria
Statement 21 Aug 2020

South Sudan
A forgotten crisis continues
Project Update 20 Aug 2020
The Jonglei and Greater Pibor administrative areas of South Sudan have seen repeated cycles of bitter inter-communal fighting – some lasting for months at a time – throughout 2020.  The latest escalation, from June to mid August saw thousands of people displaced. Many continue to  live in the bush without healthcare, food, shelter or water and sanitation.

Spain
MSF calls for urgent measures in care homes to prevent more deaths from COVID-19
Press Release 20 Aug 2020
An MSF report published this week highlights serious problems in Spain’s response to COVID-19 in nursing homes across the country, resulting in horrific mortality rates among the elderly.

National Vaccine Program Office – U.S. HHS [to 22 Aug 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC Meetings
September 23-24, 2020 Meeting (Virtual)
February 4-5, 2021 NVAC Meeting
June 16-17, 2021 NVAC Meeting

NIH [to 22 Aug 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
No new digest content identified.

PATH [to 22 Aug 2020]
https://www.path.org/media-center/
Aug. 19, 2020
PATH congratulates India on approving first locally produced pneumococcal vaccine
Serum Institute of India’s pneumococcal conjugate vaccine, PNEUMOSIL®, has received marketing authorization in India—adding a quality-certified and more affordable option to the country’s pneumonia prevention toolkit.

Aug. 12, 2020
PATH CEO announces global leadership changes
August 12, 2020 – PATH announced the creation of four new executive leadership positions that will support the global organization’s next strategy toward a more equitable organization and advance a sustainability agenda.
…The four new Executive Team positions are as follows:
Chief of the Africa Region – Nanthalile Mugala, MD, MMed
The position of Chief of the Africa Region, to be filled by Dr. Nanthalile Mugala, will lead a newly created Africa Region Division. This new executive role, effective October 1, 2020, provides strategic leadership and guidance, overseeing program activities in the region. This is a demonstration of an intentional shift in power to leaders who will advance locally designed solutions for the communities PATH serves, always in alignment with national partners and national plans…

Chief of Asia/Middle East/Europe (AMEE) Region – to be hired
All country programs in Asia and Europe will become part of the Asia/Middle East/Europe (AMEE) Region, to be led by a Chief of the Asia/Middle East/Europe (AMEE) Region. This role is similar to the Chief of the Africa Region and PATH will be filling this position in the near future. Recruitment for this position will begin in the coming weeks.

David Fleming, MD, VP of Global Health Programs, who currently leads the organization’s public health and country programs, is stepping into a new role, Senior Vice President of Public Health, to make room for regional leadership positions at the executive level. “Our next step toward equity is to elevate country leadership to our Executive Team and to no longer have our non-US programs represented by a Seattle-based leader,” said Dr. Fleming. In this new role, Dr. Fleming will serve as Chief Medical Officer and Public Health Officer for the organization.

Chief of Business and Financial Operations – Philippe Guinot
PATH’s Operations and Finance divisions will merge into a single new division focused on optimizing global business activities and revenue generation and will be led by the Chief of Business and Financial Operations, a new position to be filled by Philippe Guinot, effective October 1, 2020. This move is designed to create greater alignment around revenue generation and donor partnerships…

Chief of External Affairs – Carla Costa Sandine
To oversee institutional marketing and communications, advocacy and public policy, and philanthropy, and to co-lead PATH’s institutional diversity, equity, and inclusion initiative, Carla Costa Sandine has been promoted to Chief of External Affairs, a new position leading the External Affairs division. Ms. Sandine’s promotion was effective on August 1, 2020…

Sabin Vaccine Institute [to 22 Aug 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

UNAIDS [to 22 Aug 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
19 August 2020
On World Humanitarian Day, UNAIDS celebrates the work of #RealLifeHeroes

UNICEF [to 22 Aug 2020]
https://www.unicef.org/media/press-releases
Selected Press releases/Announcements
News note
08/21/2020
Children affected by Beirut explosions in need of psychological support as 50 per cent show signs of trauma
This is a summary of what was said by Marixie Mercado, UNICEF spokesperson in Geneva – to whom quoted text may be attributed – at today’s press briefing at the Palais des Nations in Geneva.

Press release
08/17/2020
COVID-19 causes disruptions to child protection services in more than 100 countries, UNICEF survey finds

Unitaid [to 22 Aug 2020]
https://unitaid.org/
Featured News
No new digest content identified.

Vaccination Acceptance Research Network (VARN) [to 22 Aug 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

Vaccine Confidence Project [to 22 Aug 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

Vaccine Education Center – Children’s Hospital of Philadelphia [to 22 Aug 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

Wellcome Trust [to 22 Aug 2020]
https://wellcome.ac.uk/news
No new digest content identified.

The Wistar Institute [to 22 Aug 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

WFPHA: World Federation of Public Health Associations [to 22 Aug 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.

World Organisation for Animal Health (OIE) [to 22 Aug 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
18/08/20
Required competences of Veterinary Services for international trade
Veterinary Services play a critical role in facilitating the international trade of animals and animal products by preventing the spread of diseases. In the current changing world, they face numerous challenges. To better identify and address them, the OIE Technical Item for 2020 provides an evaluation of current challenges and demonstrates how the OIE’s diverse programmes are instrumental in building targeted capacities amongst national Veterinary Services.

::::::

ARM [Alliance for Regenerative Medicine] [to 22 Aug 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.

BIO [to 22 Aug 2020]
https://www.bio.org/press-releases
Press Releases
BIO: FDA Oversight of Animal Biotechnology Must Be Changed
America’s position as an innovation leader is at stake 
Washington, D.C. (August 19, 2020) – The U.S. government’s system for regulating animal biotechnology – currently under the U.S. Food and Drug Administration (FDA) – is broken and is driving beneficial innovations to other countries, according to discussions taking place this week as part of the Animal Health in the Heartland virtual symposium.
Dr. Clint Nesbitt, Senior Director of Science and Regulatory Affairs for Food & Agriculture at the Biotechnology Innovation Organization (BIO), addressed symposium participants this morning during the presentation, “U.S. Oversight of Animal Biotechnology and the Need for Change.”
“Animal biotechnology holds tremendous potential for improving animal health and well-being, transforming our farming and food systems, boosting our bioeconomy, and even helping to prevent and respond to zoonotic diseases such as COVID-19,” said Nesbitt. “But these breakthroughs are dependent on a clear, timely, and science-based approval process that includes a viable path to market.”…

DCVMN – Developing Country Vaccine Manufacturers Network [to 22 Aug 2020]
http://www.dcvmn.org/
News; Upcoming events
Webinar on Tools for COVID-19 Vaccine Safety Assessment developed by the Safety Platform for Emergency vACcines (SPEAC)
27 August 2020
Organized by Vaccine Safety Working Group
Thursday, August 27th at
11 AM – 12:30 PM EDT |
5 PM – 6:30 PM CEST.
In order to register, kindly click on the following link: https://attendee.gotowebinar.com/register/1832853306915777038

ICBA – International Council of Biotechnology Associations [to 22 Aug 2020]
https://internationalbiotech.org/
News
No new digest content identified.

IFPMA [to 22 Aug 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

PhRMA [to 22 Aug 2020]
http://www.phrma.org/
Selected Press Releases, Statements
No new digest content identified.

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

Annals of Internal Medicine
18 August 2020 Volume 173, Issue 4
http://annals.org/aim/issue

Original Research
Risk for Subdeltoid Bursitis After Influenza Vaccination – A Population-Based Cohort Study
Elisabeth M. Hesse, MD, MTM&H, Ronald A. Navarro, MD, Matthew F. Daley, MD, … et al.
Shoulder bursitis has been reported as an adverse event after intramuscular vasculitis. This study estimated the risk for subdeltoid bursitis after influenza vaccination using data from the Vaccine Safety Datalink, which contains encounter information from 10.2 million members seen in 7 U.S. health care organizations.

Annals of Internal Medicine
18 August 2020 Volume 173, Issue 4
http://annals.org/aim/issue

Editorials
Vaccination-Induced Bursitis: Technique Matters
Sandra Adamson Fryhofer, MD and George W. Fryhofer, MD, MTR
In this issue, a Centers for Disease Control and Prevention–funded Vaccine Safety Datalink study of 2943493 vaccinated persons reported an additional 7.78 cases of subdeltoid bursitis per 1 million influenza vaccinations. The editorialists discuss the findings and describe vaccination techniques to prevent vaccine-associated bursitis.

Annals of Internal Medicine
18 August 2020 Volume 173, Issue 4
http://annals.org/aim/issue

History of Medicine
Biomedical Research in Times of Emergency: Lessons From History
Deborah Doroshow, MD, PhD, Scott Podolsky, MD, and Justin Barr, MD, PhD
COVID-19 has disrupted the lives of billions of people worldwide. Emergencies can stimulate substantial investment of resources that catalyze impressive scientific accomplishments but can also lead to false promises and ethical breaches. The authors discuss how history shows the importance of treating early results with caution, given that we are only beginning to understand SARS-CoV-2.

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 22 Aug 2020)

Factors related to the adoption of the Brazilian National Immunization Program Information System
One way to optimize the adoption and use of technological innovations is to understand how those involved perceive, assess and decide to use them. This study aims to analyze the attributes that influence the a…
Authors: Valéria Conceição de Oliveira, Eliete Albano de Azevedo Guimarães, Gilberto Perez, Fabiana Costa Machado Zacharias, Ricardo Bezerra Cavalcante, Tarcísio Laerte Gontijo, Humberto Ferreira de Oliveira Quites, Gabriela Gonçalves Amaral, Brener Santos Silva and Ione Carvalho Pinto
Citation: BMC Health Services Research 2020 20:759
Content type: Research article
Published on: 17 August 2020

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 22 Aug 2020)

Compassionate drug (mis)use during pandemics: lessons for COVID-19 from 2009
Patients were frequently treated for pandemic influenza with drugs not registered for this indication, but rarely under circumstances of high-quality data capture. The result was a reliance on use under compassionate circumstances, resulting in continued uncertainty regarding the potential benefits and harms of anti-viral treatment. Rapid scaling of clinical trials is critical for generating a quality evidence base during pandemics.
Authors: Amanda M. Rojek, Genevieve E. Martin and Peter W. Horby
Citation: BMC Medicine 2020 18:265
Content type: Research article
Published on: 21 August 2020

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 22 Aug 2020)

Seasonal influenza vaccination in Kenya: an economic evaluation using dynamic transmission modelling
There is substantial burden of seasonal influenza in Kenya, which led the government to consider introducing a national influenza vaccination programme. Given the cost implications of a nationwide programme, l…
Authors: Jeanette Dawa, Gideon O. Emukule, Edwine Barasa, Marc Alain Widdowson, Omu Anzala, Edwin van Leeuwen, Marc Baguelin, Sandra S. Chaves and Rosalind M. Eggo
Citation: BMC Medicine 2020 18:223
Content type: Research article
Published on: 20 August 2020

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 22 Aug 2020)

A systematic review of studies that measure parental vaccine attitudes and beliefs in childhood vaccination
Acceptance of vaccines is an important predictor of vaccine uptake. This has public health implications as those who are not vaccinated are at a higher risk of infection from vaccine preventable diseases. We a…
Authors: Amalie Dyda, Catherine King, Aditi Dey, Julie Leask and Adam G. Dunn
Citation: BMC Public Health 2020 20:1253
Content type: Research article
Published on: 17 August 2020

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 22 Aug 2020)

Bibliometric analysis of global scientific literature on vaccine hesitancy in peer-reviewed journals (1990–2019)
Vaccine hesitancy is a growing threat to national and global health security. The current study was undertaken to provide insights into the global scientific literature on vaccine hesitancy in peer-reviewed jo…
Authors: Waleed M. Sweileh
Citation: BMC Public Health 2020 20:1252
Content type: Research article
Published on: 17 August 2020

Clinical Therapeutics
July 2020 Volume 42, Issue 7, p1137-1424
http://www.clinicaltherapeutics.com/current

Original Research
The Evolution of Master Protocol Clinical Trial Designs: A Systematic Literature Review
Recent years have seen a change in the way that clinical trials are being conducted. There has been a rise of designs more flexible than traditional adaptive and group sequential trials which allow the investigation of multiple substudies with possibly different objectives, interventions, and subgroups conducted within an overall trial structure, summarized by the term master protocol. This review aims to identify existing master protocol studies and summarize their characteristics. The review also identifies articles relevant to the design of master protocol trials, such as proposed trial designs and related methods.
Elias Laurin Meyer, Peter Mesenbrink, Cornelia Dunger-Baldauf, Hans-Jürgen Fülle, Ekkehard Glimm, Yuhan Li, Martin Posch, Franz König
p1330–1360
Published online: July 1, 2020

Contemporary Clinical Trials
Volume 95 August 2020
https://www.sciencedirect.com/journal/contemporary-clinical-trials/vol/95/suppl/C

Research article Abstract only
Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review
Victoria Shepherd
Article 106054
Abstract
Informed consent is an essential requirement prior to clinical trial participation, however some ‘vulnerable’ groups, such as people with cognitive impairments and those in medical emergency situations, may lack decisional capacity to consent. This raises ethical and practical challenges when designing and conducting clinical trials involving these populations, who are frequently excluded as a result. Despite recent advances in improving informed consent processes, there has been far less attention paid to the enrolment of adults lacking capacity.
Exclusion criteria are an important determinant of the external validity of clinical trial results. The exclusion of these populations, and consent-based recruitment biases which arise from the challenges of identifying and involving surrogate decision-makers, leads to trials which are not representative of the clinical population.
This article discusses the involvement of adults who lack decisional capacity to consent in clinical trials and presents the advances over the previous decade and the remaining ethical challenges for the inclusion of this under-represented population in research.