MMWR News Synopsis Friday, September 18, 2020

MMWR News Synopsis Friday, September 18, 2020
Cancers Associated with Human Papillomavirus in American Indian and Alaska Native Populations — United States, 2013–2017

Serial Testing for SARS-CoV-2 and Virus Whole Genome Sequencing Inform Infection Risk at Two Skilled Nursing Facilities with COVID-19 Outbreaks — Minnesota, April–June 2020

Preventing COVID-19 Outbreaks in Long-Term Care Facilities Through Preemptive Testing of Residents and Staff Members — Fulton County, Georgia, March–May 2020

Association Between CMS Quality Ratings and COVID-19 Outbreaks in Nursing Homes — West Virginia, March 17–June 11, 2020

Decreased Influenza Activity During the COVID-19 Pandemic — United States, Australia, Chile, and South Africa, 2020

Transmission Dynamics of COVID-19 Outbreaks Associated with Child Care Facilities — Salt Lake City, Utah, April–July 2020

SARS-CoV-2–Associated Deaths Among Persons Aged <21 Years — United States, February 12–July 31, 2020

Progress Toward Poliovirus Containment Implementation — Worldwide, 2019–2020

China CDC

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

 

National Health Commission of the People’s Republic of China
http://en.nhc.gov.cn/
News
Sept 19: Daily briefing on novel coronavirus cases in China
On Sept 18, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 14 new cases of confirmed infections.

Rapid progress made in developing vaccine
Updated: 2020-09-17 China Daily Global
Expert says it may be available for public use as early as November
[See COBVID above for detail]

Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 19 Sep 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 19 Sep 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

 

BMGF – Gates Foundation [to 19 Sep 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
SEPTEMBER 14, 2020
Gates Foundation’s Annual Goalkeepers Report Shows COVID-19 Has Stalled 20 Years of Progress, Calls for Global Response to End the Pandemic
Report shows how economic damage has reinforced inequities and derailed achievement of the UN Sustainable Development Goals; spotlights countries innovating to meet challenges

 

Bill & Melinda Gates Medical Research Institute [to 19 Sep 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 19 Sep 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 19 Sep 2020]
http://cepi.net/
COVAX: A Moment of Truth in the Pandemic
18 Sep 2020
{See Week in Review above for detail]

 

EDCTP [to 19 Sep 2020]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
No new digest content identified.

 

Emory Vaccine Center [to 19 Sep 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 19 Sep 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020
CHMP, Last updated: 18/09/2020
… The Committee recommended granting marketing authorisations for two vaccines: MenQuadfi (meningococcal group A, C, W and Y conjugate vaccine), for prophylaxis against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y; and Supemtek (Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture)), for prophylaxis against influenza…

 

 

News: EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation
CHMP, Last updated: 18/09/2020

 

European Vaccine Initiative [to 19 Sep 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 19 Sep 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
September 18, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 18, 2020
… Testing updates:
As of today, 248 tests are authorized by FDA under EUAs; these include 198 molecular tests, 46 antibody tests, and 4 antigen tests.

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

September 16, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 16, 2020
…On September 15, 2020, the FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection, indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting, as well as the sedation of non-intubated patients prior to and/or during surgical and other procedures.

September 15, 2020 – Coronavirus (COVID-19) Update: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests
Today, the U.S. Food and Drug Administration published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA. The FDA provided these standardized samples, known as a reference panel, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their Emergency Use Authorization (EUA)…

September 15, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 15, 2020

September 14, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 14, 2020

 

Fondation Merieux [to 19 Sep 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

 

Gavi [to 19 Sep 2020]
https://www.gavi.org/
News releases
16 September 2020
A record-breaking year for childhood immunisation
Looking back over last year, Gavi’s 2019 Annual Progress Report is the fourth in a series of five covering this strategic period. Highlighting key data points, milestones and partnerships, the report offers insights into our progress during what was, in many ways, a banner year for the Vaccine Alliance.

 

GHIT Fund [to 19 Sep 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 19 Sep 2020]
https://www.theglobalfund.org/en/news/
News/Updates
News
Global Fund Partnership Has Saved 38 Million Lives – but COVID-19 Could Wipe Out Progress
14 September 2020
A new report by the Global Fund to Fight AIDS, Tuberculosis and Malaria is a call to action to urgently invest to protect decades of progress against HIV, TB and malaria that are being derailed as a knock-on effect of the COVID-19 pandemic.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 19 Sep 2020]
https://www.glopid-r.org/news/
News
The Global Preparedness Monitoring Board releases report: “A World In Disorder”
16/09/2020
[See Milestones above for detail]

 

Hilleman Laboratories [to 19 Sep 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 19 Sep 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Release
No new digest content identified.

 

IAVI [to 19 Sep 2020]
https://www.iavi.org/newsroom
FEATURES
September 15, 2020
Updated: The Effects of COVID-19 on IAVI Clinical Programs

 

 

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 19 Sep 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Asia Pacific, Indonesia, Malaysia, Myanmar, Pakistan
Asia Survey: 1 in 2 blame foreigners and rule-breakers for COVID-19
Kuala Lumpur/Geneva, 17 September 2020 – A major new survey in four Asian countries reveals nearly one in two people blame specific groups for spreading COVID-19.  The survey shows that people are blaming particular groups for spreading the coronavirus …
17 September 2020

 

IRC International Rescue Committee [to 19 Sep 2020]
http://www.rescue.org/press-release-index
Media highlights {Selected]
[No new digest content identified]

 

IVAC [to 19 Sep 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
Webinar Recording: Avoiding Barriers to Access for a COVID-19 Vaccine
The International Vaccine Access Center (IVAC) hosted a webinar on September 16th,
Description: Even before the COVID-19 pandemic, countries worked to overcome a myriad of challenges when introducing new safe and effective vaccines. While policy makers and health advocates addressed barriers, from understanding disease burden and cost effectiveness to establishing cold chain systems, preventable diseases spread, sicken populations, and cost lives. Learning from the past failures of vaccine introductions will be crucial for ensuring equitable access to a COVID-19 vaccine. Leaders and scientists in the international vaccine field discussed the barriers to vaccine access we must overcome to avoid and the role the international community will play in promoting equity in delivering a COVID-19 vaccine.
The webinar featured a presentation by Jerome Kim, MD, Director General, IVI.
Video: https://youtu.be/5U6SYVqhquY
Slides: https://www.jhsph.edu/ivac/wp-content/uploads/2020/09/Presentation_Barriers-to-Vaccine-Access.pdf

 

IVI [to 19 Sep 2020]
http://www.ivi.int/
Selected IVI News & Announcements
Typhoid: Study confirms Vi-DT conjugate vaccine is safe and immunogenic in children 6-23 months of age
September 17, 2020 – SEOUL, South Korea – A new study conducted by IVI in collaboration with SK bioscience shows that single-dose and two-dose regimens of Vi-DT typhoid conjugate vaccine (TCV) are safe and immunogenic in children 6-23 months of age, a group with high rates of typhoid fever in resource-limited settings. The findings from this study newly published online in The Lancet’s EClinicalMedicine describe the successful completion and analysis of a Phase II clinical trial of Vi-DT six months after vaccination…

 

JEE Alliance [to 19 Sep 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 19 Sep 2020]
http://www.msf.org/
Latest [Selected Announcements]
Mediterranean migration
“Enough is enough”: Time to stop the cycle of suffering for refugees on Greek islands
Project Update 17 Sep 2020

Coronavirus COVID-19 pandemic
MSF works to prevent spread of COVID-19 among indigenous people in Mato Grosso do Sul
Project Update 17 Sep 2020

Central African Republic
In times of COVID-19, malaria remains the number one killer of children in CAR
Project Update 15 Sep 2020

 

National Vaccine Program Office – U.S. HHS [to 19 Sep 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC Meetings
September 23-24, 2020 Meeting (Virtual)
Selected Agenda Topics:
:: Serving Up Equity: Health-In-All Approaches for COVID-19 Vaccination [Panel]
:: Allocation and Prioritization: Considerations and Recommendations for the Distribution of
COVID-19 Vaccines [Dr. Ezekiel Emanuel, University of Pennsylvania; CDC tbd]
:: Perspectives from the Field: Operation Warp Speed [Dr. Moncef Slaoui, HHS]
:: The Infodemic, COVID-19 Immunization, and the Public’s Health [Panel]
:: Immunization Information Systems to Support the COVID-19 Response [Panel]

 

NIH [to 19 Sep 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH funds community engagement research efforts in areas hardest hit by COVID-19
September 16, 2020 — Outreach will focus on COVID-19 awareness and education research, especially among African Americans, Hispanics/Latinos, and American Indians.
The National Institutes of Health today announced a $12 million award for outreach and engagement efforts in ethnic and racial minority communities disproportionately affected by the COVID-19 pandemic. The award to RTI International, a non-profit research institution, will support teams in 11 states established as part of the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities. These teams have received initial funding to immediately create CEAL programs, and RTI will serve as the Technical and Administrative Support and Coordination (TASC) center.
The CEAL research teams will focus on COVID-19 awareness and education research, especially among African Americans, Hispanics/Latinos, and American Indians — populations that account for over half of all reported cases in the United States. They also will promote and facilitate the inclusion and participation of these groups in vaccine and therapeutic clinical trials to prevent and treat the disease.
The communities of special focus include counties in Alabama, Arizona, California, Florida, Georgia, Louisiana, Michigan, Mississippi, North Carolina, Tennessee and Texas…

NIH awards contracts to develop innovative digital health technologies for COVID-19
September 15, 2020 — The projects represent a broad range of solutions for immediate public health needs related to the pandemic.
The National Institutes of Health has awarded seven contracts to companies and academic institutions to develop digital health solutions that help address the COVID-19 pandemic. The work could lead to user-friendly tools such as smartphone apps, wearable devices, and software that can identify and trace contacts of infected individuals, keep track of verified COVID-19 test results, and monitor the health status of infected and potentially infected individuals.
The National Cancer Institute (NCI) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB), both part of NIH, selected the seven projects from nearly 200 different ideas. The projects represent a broad range of solutions for immediate public health needs related to the pandemic, and several focus on solutions for medically underserved communities and people with limited access to health care, who are disproportionally affected by COVID-19…

Substance use disorders linked to COVID-19 susceptibility
September 14, 2020 — NIH research finds higher risk and worse outcomes for those with addiction.

 

PATH [to 19 Sep 2020]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

 

Sabin Vaccine Institute [to 19 Sep 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 19 Sep 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
18 September 2020
COVID-19 brings Jamaican people living with HIV closer together

16 September 2020
Pacific Unite concert promotes solidarity during the COVID-19 pandemic

15 September 2020
Somalia: building a stronger primary health care system

15 September 2020
Shelter for key populations in Kyrgyzstan

 

 

R

 

Unitaid [to 19 Sep 2020]
https://unitaid.org/
Featured News
No new digest content identified.

 

Vaccination Acceptance Research Network (VARN) [to 19 Sep 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 19 Sep 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 19 Sep 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 19 Sep 2020]
https://wellcome.ac.uk/news
Opinion | 16 September 2020
Could Covid-19 be fuelling drug resistance?
Gemma Buckland Merrett
Science Lead, Drug-Resistant Infections Wellcome
We need to understand the impact of Covid-19 on wider health issues to shape better public health responses and limit long-term consequences. Drug resistance is one of these, Gemma Buckland-Merrett explains.

 

The Wistar Institute [to 19 Sep 2020]
https://www.wistar.org/news/press-releases
Press Releases
Press Release
Sep. 14, 2020
Wistar Appoints Ami Patel, Ph.D., as Caspar Wistar Fellow
Caspar Wistar Fellowship launches the careers of up-and-coming biomedical researchers as top scientific leaders.

 

WFPHA: World Federation of Public Health Associations [to 19 Sep 2020]
https://www.wfpha.org/
Latest News
Statement on COVID-19 Immunization and Equitable Access to Vaccines
Friday, 18 September 2020
[See COVID above for full text]

 

World Organisation for Animal Health (OIE) [to 19 Sep 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 19 Sep 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.

 

BIO [to 19 Sep 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 19 Sep 2020]
http://www.dcvmn.org/
News; Upcoming events
14 September 2020
DCVMN Congratulates WHO African Region for Wild Polio-Free Certification
Brazzaville 25th August 2020 – The Africa Regional Certification Commission certified the WHO African Region as wild polio-free after four years without a case. With this historic milestone, five of the six WHO regions – representing over 90% of the world’s population – are now free of the wild poliovirus, moving the world closer to achieving global polio eradication…
… DCVMN company members are proud of contributing towards eradication with supply of polio vaccines to the African continent.
Despite a challenging year for global health, the certification of the African region as wild poliovirus-free is a sign of hope and progress. The resources and expertise used to eliminate wild polio have significantly contributed to Africa’s public health and outbreak response systems. The polio programme provides health benefits to local communities, from supporting the African region’s response to COVID-19 to bolstering routine immunization against other vaccine-preventable diseases.

 

ICBA – International Council of Biotechnology Associations [to 19 Sep 2020]
https://internationalbiotech.org/
News
No new digest content identified.

 

IFPMA [to 19 Sep 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA Statement on the G-FINDER Report “Landscape of Emerging Infectious Disease R&D: Preventing the Next
17 September 2020
The latest G-Finder report “Landscape of Emerging Infectious Disease R&D: Preventing the next pandemic” shows that to be better prepared in the future, the R&D funding needs to be more diversified and supported by a wider range of funders. It also highlights the central role that product development partnerships (PDPs) and initiatives such as the Coalition for Epidemic Preparedness Innovations (CEPI), play to provide a coordination mechanism which pools funding from different organizations to advance research.

IFPMA Statement to G20 Health and Finance Ministers
17 September 2020
[See G20 above for detail]

Safety of vaccinated individuals is the top priority in development of COVID-19 vaccines
15 September 2020
IFPMA is strongly committed to rigorous regulatory standards for approval of COVID-19 treatments and vaccines. No matter how urgently action is needed against the coronavirus public health emergency, it is imperative that the highest standards of quality, safety and efficacy are upheld everywhere. IFPMA member companies are fully committed to transparency in reporting clinical trial results whether these are good or bad; they support the need to inform the public of what they know, as well as what they don’t know about the vaccines in development.

The innovative vaccine industry voiced its strong commitment to rigorous regulatory standards for approval of COVID-19 vaccines in a statement. As part of this commitment, leading vaccine manufacturers issued a pledge to make the safety and well-being of vaccinated individuals a the top priority in development of the first COVID-19 vaccines.

Coinciding with the launch of the pledge, Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) wrote in an Opinion in The Financial Times: “We must prioritise thorough validation of the results of pre-clinical and clinical trials by independent expert bodies. Only the most rigorous application of science and openness in the regulatory process can ensure that everyone, starting with healthcare workers, has confidence in Covid-19 vaccines once they have been properly approved”.

 

PhRMA [to 19 Sep 2020]
http://www.phrma.org/
Selected Press Releases, Statements
Coming together to fight COVID-19: A conversation with Albert Bourla, Chairman & CEO of Pfizer, Inc.
Stephen J. Ubl   |     September 17, 2020
Over the last seven months, our industry has been working around the clock to combat the COVID-19 virus, including developing potential therapeutics to treat COVID-19 and vaccines to prevent future infections.
Last week, I had the opportunity to connect with Albert Bourla, Chairman & CEO of Pfizer Inc., about the fight against COVID-19

Guest Post: How proactivity and planning helped Novartis ensure a stable supply of medicines during COVID-19
Guest Contributor   |     September 16, 2020
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view. Today, we are pleased to welcome a guest post from Steffen Lang, Ph.D., Global Head of Novartis Technical Operations to discuss how Novartis has plans in place to help ensure their supply chains remain operational even in unexpected situations like COVID-19.

Journal Watch

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

Postmarketing Safety of Vaccines Approved by the U.S. Food and Drug Administration – A Cohort Study

Annals of Internal Medicine
15 September 2020 Volume 173, Issue 6
http://annals.org/aim/issue

 

Original Research
Postmarketing Safety of Vaccines Approved by the U.S. Food and Drug Administration – A Cohort Study
Noam Tau, MD, Dafna Yahav, MD, and Daniel Shepshelovich, MD
Vaccinations are an important public health strategy that has reduced morbidity and mortality from many infectious diseases. Postmarketing surveillance helps to detect vaccine-related adverse events or long-term complications. This cohort study describes the prevalence and types of safety issues reported for vaccines approved by the U.S. Food and Drug Administration between 1996 and 2015.
Conclusion:
Over a 20-year period, vaccines were found to be remarkably safe. A large proportion of safety issues were identified through existing postmarketing surveillance programs and were of limited clinical significance. These findings confirm the robustness of the vaccine approval system and postmarketing surveillance.

Maternal vaccinations coverage and reasons for non-compliance – a cross-sectional observational study

BMC Pregnancy and Childbirth
http://www.biomedcentral.com/bmcpregnancychildbirth/content
(Accessed 19 Sep 2020)

 

Maternal vaccinations coverage and reasons for non-compliance – a cross-sectional observational study
Maternal influenza and pertussis vaccinations have been proven safe and effective in reducing maternal and infant morbidity and mortality. Though recommended, not all pregnant women receive these important vac… [Israel]
Authors: David Drezner, Michal Youngster, Hodaya Klainer and Ilan Youngster
Citation: BMC Pregnancy and Childbirth 2020 20:541
Content type: Research article
Published on: 16 September 2020

Spatial access inequities and childhood immunisation uptake in Kenya

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 19 Sep 2020)

 

Spatial access inequities and childhood immunisation uptake in Kenya
Poor access to immunisation services remains a major barrier to achieving equity and expanding vaccination coverage in many sub-Saharan African countries. In Kenya, the extent to which spatial access affects i…
Authors: Noel K. Joseph, Peter M. Macharia, Paul O. Ouma, Jeremiah Mumo, Rose Jalang’o, Peter W. Wagacha, Victor O. Achieng, Eunice Ndung’u, Peter Okoth, Maria Muñiz, Yaniss Guigoz, Rocco Panciera, Nicolas Ray and Emelda A. Okiro
Citation: BMC Public Health 2020 20:1407
Content type: Research article
Published on: 15 September 2020

Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs

Ethics & Human Research
Volume 42, Issue 5 Pages: 1-40 September–October 2020
https://onlinelibrary.wiley.com/toc/25782363/current

 

Participants with autism • Big data and pragmatic trials • Covid‐19 research
Articles
Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs
Agata Ferretti, Marcello Ienca, Samia Hurst, Effy Vayena
Pages: 17-28
First Published: 16 September 2020
ABSTRACT
The increased use of big data in the medical field has shifted the way in which biomedical research is designed and carried out. The novelty of techniques and methods brought by big data research brings new challenges to institutional review boards (IRBs). Yet it is unclear if IRBs should be the responsible oversight bodies for big data research and, if so, which criteria they should use. A large but heterogenous set of ethics guidelines and normative responses have emerged to address these issues. In this study, we conducted a scoping review of soft‐law documents and guidelines with the aim of assessing ongoing normative efforts that are proliferating in this domain. We also synthesize a set of recurrent guidelines that could work as a baseline to create a harmonized process for big data research ethics.

HIV/AIDS research in Africa and the Middle East: participation and equity in North-South collaborations and relationships

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

 

Articles
HIV/AIDS research in Africa and the Middle East: participation and equity in North-South collaborations and relationships
HIV/AIDS has attracted considerable research attention since the 1980s. In the current context of globalization and the predominance of cooperative work, it is crucial to analyze the participation of the countries and regions where the infection is most prevalent. This study assesses the participation of African countries in publications on the topic, as well as the degree of equity or influence existing in North-South relations.
Authors: Gregorio González-Alcaide, Marouane Menchi-Elanzi, Edy Nacarapa and José-Manuel Ramos-Rincón
Content type: Research
17 September 2020

Budget line items for immunization in 33 African countries

Health Policy and Planning
Volume 35, Issue 7, August 2020
https://academic.oup.com/heapol/issue/35/6

 

Original Articles
Budget line items for immunization in 33 African countries
Ulla K Griffiths, Jennifer Asman, Alex Adjagba, Marina Yo, James O Oguta …
Health Policy and Planning, Volume 35, Issue 7, August 2020, Pages 753–764, https://doi.org/10.1093/heapol/czaa040
Abstract
The Global Strategy for Women’s Children’s and Adolescents’ Health emphasizes accountability as essential to ensure that decision-makers have the information required to meet the health needs of their populations and stresses the importance of tracking resources, results, and rights to see ‘what works, what needs improvement and what requires increased attention’. However, results from accountability initiatives are mixed and there is a lack of broadly applicable, validated tools for planning, monitoring and evaluating accountability interventions. This article documents an effort to transform accountability markers—including political will, leadership and the monitor–review–act cycle—into a measurement tool that can be used prospectively or retrospectively to plan, monitor and evaluate accountability initiatives. It describes the development process behind the tool including the literature review, framework development and subsequent building of the measurement tool itself. It also examines feedback on the tool from a panel of global experts and the results of a pilot test conducted in Bauchi and Gombe states in Nigeria. The results demonstrate that the tool is an effective aid for accountability initiatives to reflect on their own progress and provides a useful structure for future planning, monitoring and evaluation. The tool can be applied and adapted to other accountability mechanisms working in global health.

The development of a new accountability measurement framework and tool for global health initiatives

Health Policy and Planning
Volume 35, Issue 7, August 2020
https://academic.oup.com/heapol/issue/35/6

 

The development of a new accountability measurement framework and tool for global health initiatives
Adriane Martin Hilber, Patricia Doherty, Andrea Nove, Rachel Cullen, Tunde Segun …
Health Policy and Planning, Volume 35, Issue 7, August 2020, Pages 765–774, https://doi.org/10.1093/heapol/czz170

An analysis of the strategic plan development processes of major public organisations funding health research in nine high-income countries worldwide

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 19 Sep 2020]

 

Research
An analysis of the strategic plan development processes of major public organisations funding health research in nine high-income countries worldwide
There have been claims that health research is not satisfactorily addressing healthcare challenges. A specific area of concern is the adequacy of the mechanisms used to plan investments in health research. How…
Authors: Cristina Morciano, Maria Cristina Errico, Carla Faralli and Luisa Minghetti
Citation: Health Research Policy and Systems 2020 18:106
Published on: 18 September 2020

Transforming the practice of medicine through team science

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 19 Sep 2020]

Transforming the practice of medicine through team science
The translation of biomedical research discoveries into clinical practice is marked by extended timelines (averaging 17 years) and multiple sequential process steps. However, even after a drug, device, diagnostic tool or unique therapeutic procedure successfully navigates through clinical testing to approval, real barriers remain in applying and scaling the innovation in practice.

 

Authors: Jason H. Pitzen, Heidi L. Dieter, Darren L. Gronseth, Amber K. Dahl, Venessa L. Boyle, Tharana Maran, C. Michel Harper Jr and Gregory J. Gores
Citation: Health Research Policy and Systems 2020 18:104
Content type: Study Protocol
Published on: 17 September 2020

Reverse vaccinology assisted designing of multiepitope-based subunit vaccine against SARS-CoV-2

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 19 Sep 2020]

 

Reverse vaccinology assisted designing of multiepitope-based subunit vaccine against SARS-CoV-2
Authors: Muhammad Tahir ul Qamar, Farah Shahid, Sadia Aslam, Usman Ali Ashfaq, Sidra Aslam, Israr Fatima, Muhammad Mazhar Fareed, Ali Zohaib and Ling-Ling Chen
Content type: Research Article
16 September 2020

COVID-19 and routine childhood immunization in Africa: Leveraging systems thinking and implementation science to improve

International Journal of Infectious Diseases
September 2020 Volume 98, p1-502
https://www.ijidonline.com/issue/S1201-9712(20)X0010-5

 

COVID-19 and routine childhood immunization in Africa: Leveraging systems thinking and implementation science to improve immunization system performance
Abdu A. Adamu, Rabiu I. Jalo, Desire Habonimana, Charles S. Wiysonge
p161–165
Published online: June 24, 2020

Advancing COVID-19 vaccines – avoiding different regulatory standards for different vaccines and need for open and transparent data sharing

International Journal of Infectious Diseases
September 2020 Volume 98, p1-502
https://www.ijidonline.com/issue/S1201-9712(20)X0010-5

 

Advancing COVID-19 vaccines – avoiding different regulatory standards for different vaccines and need for open and transparent data sharing
Eskild Petersen, Christian Wejse, Alimuddin Zumla
p501–502
Published online: August 18, 2020
[See COVID above for abstracts]

Association of Routine Infant Vaccinations With Antibody Levels Among Preterm Infants

JAMA
September 15, 2020, Vol 324, No. 11, Pages 1019-1116
https://jamanetwork.com/journals/jama/currentissue

 

Original Investigation
Association of Routine Infant Vaccinations With Antibody Levels Among Preterm Infants
Elsbeth D. M. Rouers, MD; Patricia C. J. Bruijning-Verhagen, MD, PhD; Pieter G. M. van Gageldonk, BSc; et al.
has active quiz
JAMA. 2020;324(11):1068-1077. doi:10.1001/jama.2020.12316
This cohort study evaluates IgG antibody concentrations in preterm infants after administration of combination diphtheria–tetanus toxoids–acellular pertussis–inactivated poliomyelitis–Haemophilus influenza type b–and hepatitis B (DTaP-IPV-Hib-HepB) and pneumococcal conjugate vaccines.

Policies Among US Pediatricians for Dismissing Patients for Delaying or Refusing Vaccination

JAMA
September 15, 2020, Vol 324, No. 11, Pages 1019-1116
https://jamanetwork.com/journals/jama/currentissue

 

Research Letter
Policies Among US Pediatricians for Dismissing Patients for Delaying or Refusing Vaccination
Sean T. O’Leary, MD, MPH; Jessica R. Cataldi, MD, MSCS; Megan C. Lindley, MPH; et al.
JAMA. 2020;324(11):1105-1107. doi:10.1001/jama.2020.10658
This survey study assesses US pediatrician practices and office policies in response to parents who either refuse primary vaccinations or request to spread out individual vaccines in the primary series.

Addressing Influenza Vaccination Disparities During the COVID-19 Pandemic

JAMA
September 15, 2020, Vol 324, No. 11, Pages 1019-1116
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
Addressing Influenza Vaccination Disparities During the COVID-19 Pandemic
Lisa A. Grohskopf, MD, MPH; Leandris C. Liburd, PhD, MPH; Robert R. Redfield, MD
free access has active quiz has multimedia has audio
JAMA. 2020;324(11):1029-1030. doi:10.1001/jama.2020.15845
In this Viewpoint, CDC scientists discuss the public health urgency of increasing influenza vaccination uptake early in the 2020-2021 season to ameliorate the threat to patients and hospitals of overlapping outbreaks, and urges clinicians to strongly recommend the vaccine and administer it to patients whenever and wherever possible.
Conversations with Dr Bauchner: Coronavirus Update From the CDC – August 20, 2020

Ethical Considerations for COVID-19 Vaccine Trials in Correctional Facilities

JAMA
September 15, 2020, Vol 324, No. 11, Pages 1019-1116
https://jamanetwork.com/journals/jama/currentissue

 

Ethical Considerations for COVID-19 Vaccine Trials in Correctional Facilities
Emily A. Wang, MD, MAS; Jonathan Zenilman, MD, PhD; Lauren Brinkley-Rubinstein, PhD
free access has active quiz
JAMA. 2020;324(11):1031-1032. doi:10.1001/jama.2020.15589
This Viewpoint discusses the importance of studying coronavirus disease 2019 (COVID-19) vaccine candidates in prisoners, and proposes a framework for considering how to include them safely, ethically, and without coercion in future phase 3 vaccine trials.

Inflow restrictions can prevent epidemics when contact tracing efforts are effective but have limited capacity

Journal of the Royal Society – Interface
September 2020 Volume 17 Issue 170
https://royalsocietypublishing.org/toc/rsif/current

 

Life Sciences–Mathematics interface
Report
Inflow restrictions can prevent epidemics when contact tracing efforts are effective but have limited capacity
Hannes Malmberg and Tom Britton
Published:09 September 2020Article ID:20200351
https://doi.org/10.1098/rsif.2020.0351

Consent to Trainee Involvement in Pediatric Care

New England Journal of Medicine
September 17, 2020 Vol. 383 No. 12
http://www.nejm.org/toc/nejm/medical-journal

 

Perspective
Consent to Trainee Involvement in Pediatric Care
Emily A. Largent, J.D., Ph.D., R.N.
Consent to the involvement of students, interns, and residents in the care of children has received scant attention as compared with consent for either care or research. But there are compelling reasons for routinely obtaining children’s assent to trainee involvement.

Tolerance in the Age of Immunotherapy

New England Journal of Medicine
September 17, 2020 Vol. 383 No. 12
http://www.nejm.org/toc/nejm/medical-journal

 

Review Article
Tolerance in the Age of Immunotherapy
Jeffrey A. Bluestone, Ph.D., and Mark Anderson, M.D., Ph.D.
The immune system distinguishes between “self” and “nonself” and remembers dangerous exposures. Elaborate mechanisms control immune responses, but in some cases, the response either does not recognize the danger or causes unwanted autoinflammation. The authors review advances in developing durable immune tolerance

Trump lied about science

Science
18 September 2020 Vol 369, Issue 6510
http://www.sciencemag.org/current.dtl

 

Editorial
Trump lied about science
By H. Holden Thorp
Summary
When President Donald Trump began talking to the public about coronavirus disease 2019 (COVID-19) in February and March, scientists were stunned at his seeming lack of understanding of the threat. We assumed that he either refused to listen to the White House briefings that must have been occurring or that he was being deliberately sheltered from information to create plausible deniability for federal inaction. Now, because famed Washington Post journalist Bob Woodward recorded him, we can hear Trump’s own voice saying that he understood precisely that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was deadly and spread through the air. As he was playing down the virus to the public, Trump was not confused or inadequately briefed: He flat-out lied, repeatedly, about science to the American people. These lies demoralized the scientific community and cost countless lives in the United States.

Global citizen deliberation on genome editing

Science
18 September 2020 Vol 369, Issue 6510
http://www.sciencemag.org/current.dtl

 

Policy Forum
Global citizen deliberation on genome editing
By John S. Dryzek, Dianne Nicol, Simon Niemeyer, Sonya Pemberton, Nicole Curato, André Bächtiger, Philip Batterham, Bjørn Bedsted, Simon Burall, Michael Burgess, Gaetan Burgio, Yurij Castelfranchi, Hervé Chneiweiss, George Church, Merlin Crossley, Jantina de Vries, Mahmud Farooque, Marit Hammond, Baogang He, Ricardo Mendonça, Jennifer Merchant, Anna Middleton, John E. J. Rasko, Ine Van Hoyweghen, Antoine Vergne
Science18 Sep 2020 : 1435-1437
Global governance can be informed by a deliberative assembly composed of lay citizens
Summary
Genome editing technologies provide vast possibilities for societal benefit, but also substantial risks and ethical challenges. Governance and regulation of such technologies have not kept pace in a systematic or internationally consistent manner, leaving a complex, uneven, and incomplete web of national and international regulation (1). How countries choose to regulate these emergent technologies matters not just locally, but globally, because the implications of technological developments do not stop at national boundaries. Practices deemed unacceptable in one country may find a more permissive home in another: not necessarily through national policy choice, but owing to a persistent national legal and regulatory void that enables “ethics dumping” (2)—for example, if those wanting to edit genes to “perfect” humans seek countries with little governance capacity. Just as human rights are generally recognized as a matter of global concern, so too should technologies that may impinge on the question of what it means to be human. Here we show how, as the global governance vacuum is filled, deliberation by a global citizens’ assembly should play a role, for legitimate and effective governance.

Influenza vaccination coverage among adults with diabetes, United States, 2007–08 through 2017–18 seasons

Vaccine
Volume 38, Issue 42 Pages 6485-6658 (29 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/42

 

Research article Abstract only
Influenza vaccination coverage among adults with diabetes, United States, 2007–08 through 2017–18 seasons
Mei-Chuan Hung, Peng-jun Lu, Anup Srivastav, Yiling J. Cheng, Walter W. Williams

Self-reported immunity and opinions on vaccination of hospital personnel among paediatric healthcare workers in Denmark

Vaccine
Volume 38, Issue 42 Pages 6485-6658 (29 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/42

 

Research article Full text access
Self-reported immunity and opinions on vaccination of hospital personnel among paediatric healthcare workers in Denmark
Marie-Louise von Linstow, Thilde Nordmann Winther, Anna Eltvedt, Allan Bybeck Nielsen, … Anja Poulsen

A prospective cohort study of immunogenicity of quadrivalent human papillomavirus vaccination among Alaska Native Children, Alaska, United States

Vaccine
Volume 38, Issue 42 Pages 6485-6658 (29 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/42

 

Research article Abstract only
A prospective cohort study of immunogenicity of quadrivalent human papillomavirus vaccination among Alaska Native Children, Alaska, United States
Michael G. Bruce, Elissa Meites, Lisa Bulkow, Gitika Panicker, … Lauri E. Markowitz

Cost-effectiveness of SMS appointment reminders in increasing vaccination uptake in Lagos, Nigeria: A multi-centered randomized controlled trial

Vaccine
Volume 38, Issue 42 Pages 6485-6658 (29 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/42

 

Research article Abstract only
Cost-effectiveness of SMS appointment reminders in increasing vaccination uptake in Lagos, Nigeria: A multi-centered randomized controlled trial
Yoshito Kawakatsu, Adefunke Oyeniyi Adesina, Nobuhiro Kadoi, Hirotsugu Aiga

Cost-effectiveness of SMS appointment reminders in increasing vaccination uptake in Lagos, Nigeria: A multi-centered randomized controlled trial

Vaccine
Volume 38, Issue 42 Pages 6485-6658 (29 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/42

 

Research article Abstract only
Cost-effectiveness of SMS appointment reminders in increasing vaccination uptake in Lagos, Nigeria: A multi-centered randomized controlled trial
Yoshito Kawakatsu, Adefunke Oyeniyi Adesina, Nobuhiro Kadoi, Hirotsugu Aiga

Vaccination and Vaccine Effectiveness: A Commentary of Special Issue Editors

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 19 Sep 2020)

 

Open Access Editorial
Vaccination and Vaccine Effectiveness: A Commentary of Special Issue Editors
by Claudio Costantino , Alessandra Casuccio and Vincenzo Restivo
Vaccines 2020, 8(3), 545; https://doi.org/10.3390/vaccines8030545 – 18 Sep 2020
Abstract
The Special Issue “Vaccination and Vaccine Effectiveness”, published in the journal Vaccines, has the main aim to increase international literature data on vaccine effectiveness and safety and on vaccination strategies in order to reduce vaccine hesitancy and improve vaccination coverage rates. The main topics included in the call for papers were vaccines administered to infants, adolescents, adults, elderly people, at-risk populations (due to comorbidities and personal risk factors) and healthcare workers and strategies adopted to promote vaccination adherence among these categories. This Special Issue started from the assumption that, despite vaccination being universally recognized as one of the best strategies to increase duration and quality of life during the last centuries, vaccination coverage rates are often under the levels recommended to reduce circulation and to extinguish vaccine-preventable diseases. Vaccine hesitancy involves at least 15% of the general population, and healthcare workers also sometimes demonstrate doubts on vaccination effectiveness and safety. At the end of the six-month submission period, 16 articles (15 research article and one review) were accepted after the peer-review processes and published online.

A Review of Methodological Considerations for Economic Evaluations of Gene Therapies and Their Application in Literature

Value in Health
September 2020 Volume 23, Issue 9, p1119-1280
https://www.valueinhealthjournal.com/issue/S1098-3015(20)X0011-8

 

SYSTEMATIC LITERATURE REVIEW
A Review of Methodological Considerations for Economic Evaluations of Gene Therapies and Their Application in Literature
Renske M.T. ten Ham, Olaf H. Klungel, Hubert G.M. Leufkens, Geert W.J. Frederix
p1268–1280
Published online: August 18, 2020
Results
The first literature search yielded 13 articles discussing methodological considerations. The second search provided 12 EEs. Considerations identified were payment models, definition of perspectives, addressing uncertainty, data extrapolation, discount rates, novel value elements, and use of indirect and surrogate endpoints. All EEs scored satisfactory to good according to Consolidated Health Economic Evaluation Reporting Standards. Regarding methodological application, we found 1 methodological element (payment models) was applied in 2 base cases. Scenarios explored alternative perspectives, survival assumptions, and extrapolation methods in 10 EEs.
Conclusions
Although EE quality of reporting was considered good, their informativeness for health technology assessment and decision makers seemed limited owing to many uncertainties. We suggest accepted EE methods can broadly be applied to GTs, but few elements may need adjustment. Further research and multi-stakeholder consensus is needed to determine appropriateness and application of individual methodological considerations. For now, we recommend including scenario analyses to explore impact of methodological choices and (clinical) uncertainties. This study contributes to better understanding of perceived appropriate evaluation of GTs and informs best modeling practices.

Media/Policy Watch

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 19 Sep 2020
[No new, unique, relevant content]

 

BBC
http://www.bbc.co.uk/
Accessed 19 Sep 2020
[No new, unique, relevant content]

 

The Economist
http://www.economist.com/
Accessed 19 Sep 2020
[No new, unique, relevant content]

 

Forbes
http://www.forbes.com/
Accessed 19 Sep 2020
Sep 18, 2020
Why We Can’t Rely On Natural Immunity To Protect Us From Covid-19
A new study, compounded with recent reports of reinfection, shows why building immunity to Covid-19 is trickier than we’d like to believe.
By William A. Haseltine Contributor

Sep 17, 2020
Trump Says His Only Failure In ‘Phenomenal’ Coronavirus Response Was ‘Public Relations’
The president has argued people should trust a vaccine ‘because of the great job we’ve done,’ but polls show the majority of Americans disagree.
By Andrew Solender Forbes Staff

Sep 17, 2020
Nearly Half Of All Americans, Including Most Republicans, Say They Would Not Get Covid-19 Vaccine
56% of Republicans said definitely or probably would not get vaccinated.
By Tommy Beer Forbes Staff

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 19 Sep 2020
September 16, 2020
America Needs to Lock Down Again
To get the novel coronavirus under control, the United States must impose stringent lockdowns across the country for roughly two months.
Michael T. Osterholm and Mark Olshaker

 

Foreign Policy
http://foreignpolicy.com/
Accessed 19 Sep 2020
The World Is Winning—and Losing—the Vaccine Race
Immunization to COVID-19 is supposed to solve our problems—but it’s starting to trigger even bigger ones.
By Adam Tooze
September 19, 2020, 6:00 AM

 

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

 

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

 

New York Times
http://www.nytimes.com/
Accessed 19 Sep 2020
Health
AstraZeneca, Under Fire for Vaccine Safety, Releases Trial Blueprints
Experts are concerned that the company has not been more forthcoming about two participants who became seriously ill after getting its experimental vaccine.
By Denise Grady, Katherine J. Wu and Sharon LaFraniere
PRINT EDITIONSeptember 21, 2020

Health
In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over F.D.A.
Experts said the memo would make it more difficult for the F.D.A. to issue new rules, but it’s unclear how it would affect the vetting of coronavirus vaccines.
By Sheila Kaplan

Health
C.D.C. Testing Guidance Was Published Against Scientists’ Objections
A controversial guideline saying people without Covid-19 symptoms didn’t need to get tested for the virus came from H.H.S. officials and skipped the C.D.C.’s scientific review process.
By Apoorva Mandavilli
Sept. 17

 

Washington Post
https://www.washingtonpost.com/
Accessed 19 Sep 2020
Democrats face quandary on vaccine support as election nears
Sep 19, 2020

China and Russia are ahead in the global coronavirus vaccine race, bending long-standing rules
Eva Dou and Isabelle Khurshudyan · Sep 18, 2020

Vaccine companies reveal their study designs, even as Trump sows confusion
Carolyn Y. Johnson · Health · Sep 17, 2020