Vaccines and Global Health: The Week in Review 14 September 2019

Center for Vaccine Ethics & Policy (CVEP) This weekly digest targets news, events, announcements, articles and research in the vaccine and global health ethics and policy space and is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. Vaccines and Global Health: The Week in Review is also posted in pdf form and as a set of blog posts at https://centerforvaccineethicsandpolicy.net. This blog allows full-text searching of over 8,000 entries. Comments and suggestions should be directed to

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

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

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Contents [click on link below to move to associated content] A. Milestones :: Perspectives :: Featured Journal Content B. Emergencies C. WHO; CDC [U.S., Africa, China] D. Announcements E. Journal Watch F. Media Watch

:::::: :::::: Milestones :: Perspectives :: Research :::::: :::::: Malaria vaccine launched in Kenya: Kenya joins Ghana and Malawi to roll out landmark vaccine in pilot introduction Homa Bay, Kenya, 13 September 2019 – The World Health Organization (WHO) congratulates the Government of Kenya for launching the world’s first malaria vaccine today in Homa Bay County, western Kenya. The malaria vaccine pilot programme is now fully underway in Africa, as Kenya joins Ghana and Malawi to introduce the landmark vaccine as a tool against a disease that continues to affect millions of children in Africa. The vaccine, known as RTS,S, will be available to children from 6 months of age in selected areas of the country in a phased pilot introduction. It is the first and only vaccine to significantly reduce malaria in children, including life-threatening malaria. Malaria claims the life of one child every two minutes. The disease is a leading killer of children younger than 5 years in Kenya. “Africa has witnessed a recent surge in the number of malaria cases and deaths. This threatens the gains in the fight against malaria made in the past two decades,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “The ongoing pilots will provide the key information and data to inform a WHO policy on the broader use of the vaccine in sub-Saharan Africa. If introduced widely, the vaccine has the potential to save tens of thousands of lives.” First vaccination: a day to celebrate Distinguished health officials, community leaders and health advocates gathered in Homa Bay County – one of eight counties in Kenya where the vaccine will be introduced in selected areas – to mark this historic moment with declarations of support for the promising new malaria prevention tool and to demonstrate a ceremonial first vaccination of a 6-month-old child. Speaking at the event, WHO Representative to Kenya Dr Rudi Eggers said: “Vaccines are powerful tools that effectively reach and better protect the health of children who may not have immediate access to the doctors, nurses and health facilities they need to save them when severe illness comes. This is a day to celebrate as we begin to learn more about what this vaccine can do to change the trajectory of malaria though childhood vaccination.” Thirty years in the making, the vaccine is a complementary malaria control tool – to be added to the core package of WHO-recommended measures for malaria prevention, including the routine use of insecticide-treated bed nets, indoor spraying with insecticides and timely access to malaria testing and treatment…

:::::: :::::: 2019 Lasker~Bloomberg Public Service Award :: Gavi, the Vaccine Alliance For providing sustained access to childhood vaccines around the globe, saving millions of lives, and for highlighting the power of immunization to prevent disease The 2019 Lasker~Bloomberg Public Service Award honors Gavi, the Vaccine Alliance, for providing sustained access to childhood vaccines around the globe, thus saving millions of lives, and for highlighting the power of immunization to prevent disease. By harnessing the latest scientific advances, collaborating, and exercising economic influence, Gavi ensures sufficient vaccine supplies at affordable prices, accelerates development and deployment of new vaccines, and strengthens healthcare systems. To date, Gavi has helped vaccinate more than 760 million children and saved over 13 million lives in 73 countries. Bill Gates has famously said, “vaccines are a miracle” and, although they are a product of research and not supernatural forces, their effects touch on the divine. According to the World Health Organization (WHO), immunization prevents between 2 and 3 million deaths every year. Its success has created one of the most dramatic and cost-effective public health stories in history. Gavi receives the 2019 Lasker~Bloomberg Public Service Award Award given for saving millions of lives by providing sustained access to childhood vaccines around the globe Geneva, 10 September 2019 – The Albert and Mary Lasker Foundation announced today that Gavi, the Vaccine Alliance has received the prestigious 2019 Lasker~Bloomberg Public Service Award for providing sustained access to childhood vaccines in the world’s poorest countries, saving millions of lives and highlighting the power of immunisation to prevent diseases. “It is a great honour for us to receive such a prestigious Award,” said Dr Seth Berkley, CEO of Gavi the Vaccine Alliance. “Since its creation in 2000 at Davos, Gavi has been making it possible for the world’s most vulnerable children to receive the vaccines they need to live healthy, successful lives. Our collective work as an Alliance has prevented more than 13 million deaths in developing countries while child mortality was halved largely thanks to immunisation. I couldn’t be prouder of what we have accomplished together… :::::: :::::: Emergencies Ebola – DRC+ Public Health Emergency of International Concern (PHEIC) Ebola virus disease – Democratic Republic of the Congo Disease Outbreak News (DONs) 6 September 2019

The intensity of Ebola virus disease (EVD) transmission in the North Kivu, South Kivu, and Ituri provinces remains substantial, with 57 new cases reported since the last EVD in the Democratic Republic of the Congo Disease Outbreak News Update on 29 August. :::::: :::::: POLIO Public Health Emergency of International Concern (PHEIC) Polio this week as of 11 September 2019 :: The Global Polio Eradication Initiative (GPEI) partners and the United Arab Emirates co-hosted an informal reception as a pre-event ahead of the Polio Pledging Moment in the United Arab Emirates’-hosted Reaching the Last Mile Forum in Abu Dhabi, in November 2019. The GPEI also presented the 2019-2023 GPEI Investment Case.

Summary of new viruses this week: :: Afghanistan — one wild poliovirus type 1 (WPV1) case; :: Pakistan— four wild poliovirus type 1 (WPV1) cases and 28 WPV1-positive environmental samples; :: Central African Republic (CAR)— two circulating vaccine-derived poliovirus type 2 (cVDPV2) cases and one cVDPV2-positive environmental sample; :: Democratic Republic of the Congo (DRC)— one cVDPV2 case. :::::: :::::: Editor’s Note: WHO has posted a refreshed emergencies page which presents an updated listing of Grade 3,2,1 emergencies as below. WHO Grade 3 Emergencies [to 14 Sep 2019] Democratic Republic of the Congo :: Disease Outbreak News (DONs) Ebola virus disease – Democratic Republic of the Congo 6 September 2019 Nigeria - No new digest announcements identified Mozambique floods - 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 14 Sep 2019] Afghanistan - No new digest announcements identified Angola - No new digest announcements identified

Burkina Faso [in French] - No new digest announcements identified Burundi - No new digest announcements identified Cameroon - No new digest announcements identified Central African Republic - No new digest announcements identified Ethiopia - No new digest announcements identified HIV in Pakistan - No new digest announcements identified Iran floods 2019 - No new digest announcements identified Iraq - No new digest announcements identified Libya - No new digest announcements identified Malawi floods - No new digest announcements identified Measles in Europe - No new digest announcements identified MERS-CoV - No new digest announcements identified Myanmar - No new digest announcements identified Niger – No new digest announcements identified occupied Palestinian territory - No new digest announcements identified Sudan - No new digest announcements identified Ukraine - No new digest announcements identified Zimbabwe - No new digest announcements identified :::::: WHO Grade 1 Emergencies [to 14 Sep 2019] Chad - No new digest announcements identified Djibouti - No new digest announcements identified Kenya - No new digest announcements identified Mali - No new digest announcements identified Namibia - viral hepatitis - No new digest announcements identified Tanzania - No new digest announcements identified :::::: :::::: UN OCHA – L3 Emergencies The UN and its humanitarian partners are currently responding to three 'L3' emergencies. This is the global humanitarian system's classification for the response to the most severe, large-scale humanitarian crises. Syrian Arab Republic - No new digest announcements identified Yemen - No new digest announcements identified :::::: UN OCHA – Corporate Emergencies When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field. Editor’s Note: Ebola in the DRC has bene added as a OCHA “Corporate Emergency” this week: CYCLONE IDAI and Kenneth - No new digest announcements identified EBOLA OUTBREAK IN THE DRC - No new digest announcements identified

:::::: :::::: WHO & Regional Offices [to 14 Sep 2019] News release WHO calls for urgent action to reduce patient harm in healthcare 13 September 2019: Millions of patients are harmed each year due to unsafe health care worldwide resulting in 2.6 million deaths annually in low-and middle-income countries alone. Most of these deaths are avoidable. The personal, social and economic impact of patient harm leads to losses of trillions of US dollars worldwide. The World Health Organization is focusing global attention on the issue of patient safety and launching a campaign in solidarity with patients on the very first World Patient Safety Day on 17 September. “No one should be harmed while receiving health care. And yet globally, at least 5 patients die every minute because of unsafe care,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “We need a patient safety culture that promotes partnership with patients, encourages reporting and learning from errors, and creates a blame-free environment where health workers are empowered and trained to reduce errors."… 9 September 2019 News release Suicide: one person dies every 40 seconds 8 September 2019 News release PAHO issues $3.5 million donor appeal for humanitarian health response in the Bahamas :::::: Weekly Epidemiological Record, 13 September 2019, vol. 94, 37 (pp. 413–424) Algeria and Argentina certified as malaria-free by WHO Progress in eliminating onchocerciasis in the WHO Region of the Americas: doxycycline treatment as an end-game strategy Performance of acute flaccid paralysis (AFP) surveillance and incidence of poliomyelitis, 2019 :::::: WHO Regional Offices Selected Press Releases, Announcements WHO African Region AFRO :: Malaria vaccine launched in Kenya: Kenya joins Ghana and Malawi to roll out landmark... 13 September 2019 :: Ghana Health Service and Partners launch polio vaccination campaigns in Ghana 12 September 2019 :: Experts convene to chart a roadmap towards malaria elimination 10 September 2019

WHO Region of the Americas PAHO :: PAHO urges the health and education sectors to work together to create healthy schools (09/13/2019) :: PAHO hurricane relief partners, the Dutch military, evacuate pregnant woman from Abaco (09/12/2019) :: How to cope with the psychological impact of disasters (09/11/2019) :: PAHO issues $3.5 million donor appeal for humanitarian health response in the Bahamas (09/08/2019) WHO South-East Asia Region SEARO No new digest content identified. WHO European Region EURO :: RC69 opens on 16 September with review of progress in public health 13-09-2019 :: Moscow joins the WHO Regions for Health Network (RHN) 11-09-2019 :: Progress on health equity is stalling across Europe; new WHO report reveals gaps can be reduced within the lifetime of a single government 10-09-2019 WHO Eastern Mediterranean Region EMRO :: Japan contributions enable WHO support for Syrian children 12 September 2019 :: WHO sends life-saving medical supplies across Libya 9 September 20 WHO Western Pacific Region No new digest content identified. :::::: :::::: CDC/ACIP [to 14 Sep 2019] http://www.cdc.gov/media/index.html https://www.cdc.gov/vaccines/acip/index.html Latest News No new digest content identified. :::::: Africa CDC [to 14 Sep 2019] 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/ Selected Updates and Press Releases No new digest content identified. :::::: :::::: Announcements Paul G. Allen Frontiers Group [to 14 Sep 2019] https://alleninstitute.org/what-we-do/frontiers-group/news-press/ News No new digest content identified. BMGF - Gates Foundation [to 14 Sep 2019] http://www.gatesfoundation.org/Media-Center/Press-Releases No new digest content identified. Bill & Melinda Gates Medical Research Institute [to 14 Sep 2019] https://www.gatesmri.org/ The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world's poorest people No new digest content identified. CARB-X [to 14 Sep 2019] https://carb-x.org/ CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria. http://www.vaccines.emory.edu/ Website not responding at inquiry CEPI – Coalition for Epidemic Preparedness Innovations [to 14 Sep 2019] http://cepi.net/ No new digest content identified. Clinton Health Access Initiative, Inc. (CHAI) [to 14 Sep 2019] https://clintonhealthaccess.org/about/ News & Press Releases No new digest content identified.

EDCTP [to 14 Sep 2019] http://www.edctp.org/ The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials Latest news No new digest content identified. Emory Vaccine Center [to 14 Sep 2019] http://www.vaccines.emory.edu/ Website not responding at inquiry European Medicines Agency [to 14 Sep 2019] http://www.ema.europa.eu/ema/ News and press releases No new digest content identified. European Vaccine Initiative [to 14 Sep 2019] http://www.euvaccine.eu/news-events Latest news International partnership to advance the clinical development of a new vaccine against Shigella and ETEC 10 September 2019 Horizon2020 award to consortium will support the testing of an innovative live attenuated vaccine in phase I clinical trials in Europe and Bangladesh Under coordination by EVI, the SHIGETECVAX consortium, made up of partners including EVI, EveliQure, icddr,b, University of Gothenburg, and PATH, will be advancing a radically new approach for a vaccine against Shigella and ETEC, developed by EveliQure Biotechnologies. To read the full news release, please click this link FDA [to 14 Sep 2019] https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm No new digest content identified. Fondation Merieux [to 14 Sep 2019] http://www.fondation-merieux.org/ No new digest content identified. Gavi [to 14 Sep 2019] https://www.gavi.org/

Latest news Gavi receives the 2019 Lasker~Bloomberg Public Service Award Award given for saving millions of lives by providing sustained access to childhood vaccines around the globe 10 September 2019 {See Milestones above for detail] Vaccine Manufacturer GS1 Compliance 09 September 2019 Starting 1 October 2019, for vaccine tenders backed by Gavi financing issued by UNICEF, it will be a requirement to have GS1 barcoding on the secondary packaging by latest 31 December 2021. GHIT Fund [to 14 Sep 2019] https://www.ghitfund.org/newsroom/press GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical No new digest content identified. Global Fund [to 14 Sep 2019] https://www.theglobalfund.org/en/news/ Updates General Assembly of the United Nations 74th Session 09 September 2019 Updates Global Fund Strategic Review 2020 09 September 2019 …The Global Fund seeks qualified consultants/firms/consortia to perform the review, starting in October 2019. Detailed information and instructions are in the request for proposals TGF-19-076 [ download in English ] . The closing date is 4 October 2019. Hilleman Laboratories [to 14 Sep 2019] http://www.hillemanlabs.org/ No new digest content identified. Human Vaccines Project [to 14 Sep 2019] http://www.humanvaccinesproject.org/media/press-releases/ Press Releases No new digest content identified. IAVI [to 14 Sep 2019] https://www.iavi.org/newsroom

No new digest content identified. International Coalition of Medicines Regulatory Authorities (ICMRA) http://www.icmra.info/drupal/en/news Statements and Press Releases No new digest content identified. IFFIm http://www.iffim.org/library/news/press-releases/ No new digest content identified. IFRC [to 14 Sep 2019] http://media.ifrc.org/ifrc/news/press-releases/ Selected Press Releases, Announcements No new digest content identified. IVAC [to 14 Sep 2019] https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html Updates No new digest content identified. IVI [to 14 Sep 2019] http://www.ivi.int/ Selected IVI News & Announcements No new digest content identified. JEE Alliance [to 14 Sep 2019] https://www.jeealliance.org/ Selected News and Events No new digest content identified. MSF/Médecins Sans Frontières [to 14 Sep 2019] http://www.msf.org/ Mediterranean migration Ocean Viking survivors to disembark in Lampedusa six days after the first survivo… Press Release 14 Sep 2019 Rohingya refugee crisis ASEAN should show true leadership on Rohingya, Myanmar Op-Ed 13 Sep 2019

DRC Ebola outbreaks Crisis update - August 2019 Crisis Update 13 Sep 2019 Iraq Mosul's expectant mothers just can't wait Project Update 11 Sep 2019 France Unaccompanied minors, symbols of a policy of mistreatment Report 10 Sep 2019 France Rejected and traumatised: Unaccompanied minors arriving in France Project Update 10 Sep 2019 About MSF Dr Christos Christou new International President of MSF Statement 9 Sep 2019 NIH [to 14 Sep 2019] http://www.nih.gov/news-events/news-releases Selected News Releases NIAID officials call for innovative research on sexually transmitted infections September 9, 2019 — Globally, more than 1 million new STI cases are diagnosed each day. Organization of Islamic Cooperation (OIC) [to 14 Sep 2019] https://www.oic-oci.org/home/?lan=en Selected Press Releases OIC Participates in Polio Eradication Islamic Advisory Group The Sixth Annual Meeting of the Islamic Advisory Group for Polio Eradication (IAG) was held in Cairo, Arab Republic of Egypt, on 4 September 2019, under the patronage of His Eminence the Grand Sheikh of Al-Azhar Al-sharief. The Meeting was attended by Members of IAG, including representatives from the International Islamic Fiqh Academy, Islamic Development Bank Group, World Health Organization and UNICEF. Representatives of priority countries (Afghanistan, Pakistan and Somalia) also attended the meeting that reviewed progress made in the fight against polio and discussed a plan for future activities of IAG.... 05/09/2019 PATH [to 14 Sep 2019] https://www.path.org/media-center/ Selected Announcements PATH partners with Bayer Foundation to fight malaria in Senegal September 13, 2019 by PATH

PATH received a EUR 750,000 grant from the Bayer Foundation to develop a community champion and outreach program in Senegal. This funding is part of Bayer’s ongoing EUR 20 million program, which aims to support social innovation for nearly 100 million smallholder farmers and their family members by 2030. Kenya joins Malawi and Ghana to roll out the world’s first malaria vaccine Seattle, WA, September 13, 2019 – PATH congratulates Kenya as it joins Ghana and Malawi in providing the world’s first malaria vaccine to children through routine immunization. With the start of vaccination in Kenya, the World Health Organization (WHO)-coordinated Malaria Vaccine Implementation Programme (MVIP) is now fully underway… ProMED [Program for Monitoring Emerging Diseases] [to 14 Sep 2019] International Society for Infectious Diseases https://www.promedmail.org/announcements/ Selected Announcements/Posts No new digest content identified. Sabin Vaccine Institute [to 14 Sep 2019] http://www.sabin.org/updates/pressreleases No new digest content identified. UNAIDS [to 14 Sep 2019] http://www.unaids.org/en Selected Press Releases/Reports/Statements 10 September 2019 UNAIDS still ahead in implementing UN-SWAP 10 September 2019 Ending AIDS is everyone’s business 10 September 2019 Five years on: 300 Fast-Track cities come together UNICEF [to 14 Sep 2019] https://www.unicef.org/media/press-releases Selected Statements, Press Releases, Reports Press release Mozambique: Children living in storm-affected areas face worsening food insecurity and nutrition crisis six months after Cyclone Idai UNICEF projects more than 38,000 children could become severely malnourished by early 2020 14/09/2019 Press release

Hurricane Dorian: Bahamas Government and UNICEF to bring 10,000 displaced children back to school 12/09/2019 Press release Statement by UNICEF Executive Director Henrietta Fore on child deaths in Gaza 12/09/2019 Vaccination Acceptance Research Network (VARN) [to 14 Sep 2019] https://vaccineacceptance.org/news.html#header1-2r No new digest content identified. Vaccine Confidence Project [to 14 Sep 2019] http://www.vaccineconfidence.org/ No new digest content identified. Vaccine Education Center – Children’s Hospital of Philadelphia [to 14 Sep 2019] http://www.chop.edu/centers-programs/vaccine-education-center Most Recent Articles Measles Outbreaks and Flu Vaccine Season Published on Sep 03, 2019 This article includes videos and downloadable resources about measles and influenza infections and the vaccines that help to prevent them. Wellcome Trust [to 14 Sep 2019] https://wellcome.ac.uk/news Opinion | 11 September 2019 How can we improve equity in science education? by Anita Krishnamurthi Opinion | 11 September 2019 The generosity of 500,000 healthy volunteers could help us all by Sara Marshall Opinion | 10 September 2019 Why we need to reimagine how we do research by Jeremy Farrar The emphasis on excellence in the research system is stifling diverse thinking and positive behaviours. As a community we can rethink our approach to research culture. Opinion | 10 September 2019 Why are we seeing spikes in measles compared to other infectious diseases? by Charlie Weller

The Wistar Institute [to 14 Sep 2019] https://www.wistar.org/news/press-releases Press Release Sep. 12, 2019 Major Grant Awarded to Wistar Supports Development of a Novel Therapeutic Approach for Antibiotic-resistant Bacteria PHILADELPHIA — (September 12, 2019) — The Wistar Institute has received a grant of approximately $4.6 million from the National Institutes of Health in support of innovative research to tackle antibiotic resistance. World Organisation for Animal Health (OIE) [to 14 Sep 2019] http://www.oie.int/en/for-the-media/press-releases/2019/ 10/09/19 European politicians and scientists join forces to face ASF Today in Sofia, Bulgaria, high level representatives, including The European Commissioner for Health and Food Safety Vytenis Andriukaitis, the OIE Director General Dr Monique Eloit and five Agriculture Ministers1of the Balkan countries, joined the openingof the Standing Group of Experts on African swine fever(ASF)in Europe organized by the World Organisation for Animal Health (OIE), and the Food and Agriculture Organization of the United Nations (FAO). This mobilisation is a strong signal of support for the work done by veterinary experts to find adequate solutions to stop the spread of ASF in the European region… :::::: ARM [Alliance for Regenerative Medicine] [to 14 Sep 2019] https://alliancerm.org/press-releases/ https://www.bio.org/insights/press-release No new digest content identified. BIO [to 14 Sep 2019] https://www.bio.org/insights/press-release No new digest content identified. DCVMN – Developing Country Vaccine Manufacturers Network [to 14 Sep 2019] http://www.dcvmn.org/ Events DCVMN 20th Annual General Meeting 21 October 2019 to 23 October 2019 Rio de Janeiro / Brazil IFPMA [to 14 Sep 2019] http://www.ifpma.org/resources/news-releases/ Selected Press Releases, Statements, Publications

Statements New report provides a policy framework to support countries in implementing an effective life-course approach

09 September 2019 Industry and Stakeholders reaffirm their commitment to ensuring ethics and integrity across health systems 09 September 2019 PhRMA [to 14 Sep 2019] http://www.phrma.org/ Selected Press Releases, Statements Press Release Bristol-Myers Squibb CEO Giovanni Caforio Becomes PhRMA Board Chairman Washington, D.C. (September 4, 2019)—The Pharmaceutical Research and Manufacturers of America (PhRMA) is pleased to announce that Giovanni Caforio, M.D., chairman and CEO of Bristol-Myers Squibb has assumed the role of chairman of the PhRMA board of directors. Prior to today’s announcement, Caforio held the position of chairman-elect and before that, the position of treasurer for the PhRMA Board. Caforio succeeds Olivier Brandicourt, CEO, Sanofi, who announced his retirement from Sanofi effective September 1, 2019… Industry Watch [to 14 Sep 2019] Selected Announcements :: Pfizer Announces Positive Preliminary Results from a Proof-of-Concept Phase 2 Study (B7471003) of its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Otitis Media in Healthy Infants Additionally, Pfizer Has Completed Enrollment of its Phase 3 Studies (NCT03828617, NCT03835975 and NCT03760146) for its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older September 09, 2019 08:00 AM Eastern Daylight Time * * * *

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 American Journal of Infection Control September 2019 Volume 47, Issue 9, p1039-1160

http://www.ajicjournal.org/current [Reviewed earlier] American Journal of Preventive Medicine September 2019 Volume 57, Issue 3, p293-428 http://www.ajpmonline.org/current [Reviewed earlier] American Journal of Public Health September 2019 109(9) http://ajph.aphapublications.org/toc/ajph/current [Reviewed earlier] American Journal of Tropical Medicine and Hygiene Volume 101, Issue 3, 2019 http://www.ajtmh.org/content/journals/14761645/101/3 Articles Epidemic Situation of Tuberculosis in Prisons in the Central Region of China Yeqing Tong, Shunli Jiang, Xuhua Guan, Shuanyi Hou, Kun Cai, Yemeng Tong, Li Cai, Jiafa Liu and Qing Lu https://doi.org/10.4269/ajtmh.18-0987 Associations between Public Awareness, Local Precipitation, and Cholera in Yemen in 2017 Shi Zhao, Salihu S. Musa, Jing Qin and Daihai He https://doi.org/10.4269/ajtmh.18-1016 Annals of Internal Medicine 3 September 2019 Vol: 171, Issue 5 http://annals.org/aim/issue [Reviewed earlier] BMC Cost Effectiveness and Resource Allocation http://resource-allocation.biomedcentral.com/ (Accessed 14 Sep 2019) [No new digest content identified] BMJ Global Health July 2019 - Volume 4 - 4 https://gh.bmj.com/content/4/4 [Reviewed earlier]

BMC Health Services Research http://www.biomedcentral.com/bmchealthservres/content (Accessed 14 Sep 2019) Research article | 14 September 2019 Lessons from a training needs assessment to strengthen the capacity of routine immunization service providers in Nigeria Health workers (HWs) providing routine immunization (RI) services play a crucial role in influencing vaccine uptake, a key determinant of improved immunization coverage. Over the years, Training Needs Assessme... Authors: Linda Arogundade, Titilola Akinwumi, Shola Molemodile, Ebubechi Nwaononiwu, Joshua Ezika, Inuwa Yau and Chizoba Wonodi BMC Infectious Diseases http://www.biomedcentral.com/bmcinfectdis/content (Accessed 14 Sep 2019) Research article Vaccination uptake among Australian early childhood education staff: assessing perceptions, behaviours and workplace practices Early Childhood Education Centre (ECEC) staff are strongly recommended to receive several immunizations including influenza and pertussis. However, evidence regarding the uptake is either old or lacking across... Authors: Holly Seale, Stephanie Dwyer, Alamgir Kabir and Rajneesh Kaur Citation: BMC Infectious Diseases 2019 19:805 Published on: 14 September 2019 BMC Medical Ethics http://www.biomedcentral.com/bmcmedethics/content (Accessed 14 Sep 2019) [No new digest content identified] BMC Medicine http://www.biomedcentral.com/bmcmed/content (Accessed 14 Sep 2019) [No new digest content identified] BMC Pregnancy and Childbirth http://www.biomedcentral.com/bmcpregnancychildbirth/content (Accessed 14 Sep 2019) [No new digest content identified] BMC Public Health

http://bmcpublichealth.biomedcentral.com/articles (Accessed 14 Sep 2019) Research article Hepatitis B vaccination coverage across India: exploring the spatial heterogeneity and contextual determinants Although hepatitis B vaccinations have been integrated in the Universal Immunization Program (UIP) in India over a decade, only half of the children are immunized against hepatitis B. The national average in h... Authors: Junaid Khan, Apurba Shil and Sanjay K. Mohanty Citation: BMC Public Health 2019 19:1263 Published on: 12 September 2019 BMC Research Notes http://www.biomedcentral.com/bmcresnotes/content (Accessed 14 Sep 2019) [No new digest content identified] BMJ Open August 2019 - Volume 9 - 8 http://bmjopen.bmj.com/content/current [Reviewed earlier] Bulletin of the World Health Organization Volume 97, Number 9, September 2019, 581-644 https://www.who.int/bulletin/volumes/97/9/en/ [New issue; no new digest content identified] Child Care, Health and Development Volume 45, Issue 5 Pages: 613-771 September 2019 https://onlinelibrary.wiley.com/toc/13652214/current [Reviewed earlier] Clinical Therapeutics August 2019 Volume 41, Issue 8, p1401-1642 http://www.clinicaltherapeutics.com/current Drugs and Biologics Update: Artificial Intelligence and Patient-centric Approaches to Advance Pharmaceutical Innovation [Reviewed earlier] Clinical Trials Volume 16 Issue 5, October 2019 https://journals.sagepub.com/toc/ctja/16/5

Ethics Risk to bystanders in clinical trials: A symposium Nir Eyal First Published August 1, 2019; pp. 447–449 Abstract This symposium takes a critical look at the ethics of impact on “bystanders” to clinical research. By that we mean study non-participants who nevertheless are at risk of being affected by the study in some way. This introduction suggests some questions to consider while reading through the symposium contributions, and gives a précis of each. Policy Open science: The open clinical trials data journey Frank Rockhold, Christina Bromley, Erin K Wagner, Marc Buyse First Published July 26, 2019; pp. 539–546 Abstract Open data sharing and access has the potential to promote transparency and reproducibility in research, contribute to education and training, and prompt innovative secondary research. Yet, there are many reasons why researchers don’t share their data. These include, among others, time and resource constraints, patient data privacy issues, lack of access to appropriate funding, insufficient recognition of the data originators’ contribution, and the concern that commercial or academic competitors may benefit from analyses based on shared data. Nevertheless, there is a positive interest within and across the research and patient communities to create shared data resources. In this perspective, we will try to highlight the spectrum of “openness” and “data access” that exists at present and highlight the strengths and weakness of current data access platforms, present current examples of data sharing platforms, and propose guidelines to revise current data sharing practices going forward. Transparency and objectivity in governance of clinical trials data sharing: Current practices and approaches Mahsa Shabani, Mojisola Obasa First Published July 26, 2019; pp. 547–551 Abstract Sharing metadata, individual participant data and summary data, as a complement to results dissemination and trial registration requirements, is perceived to be advantageous by enabling faster and more accurate meta-analyses and reducing the need for additional trials. To date, various models of data access have been utilized in order to manage clinical trials data sharing and access in line with the rights and interests of sponsors, researchers and patients involved in clinical trials. In order to ensure responsible data sharing, the data access review process should be developed in a way that ensures fairness, transparency and objectivity. In this article, we critically review some examples of current governance models in clinical trials data sharing and suggest approaches to ensure the objectivity of the data access review process. Conflict and Health http://www.conflictandhealth.com/ [Accessed 14 Sep 2019] [No new digest content identified]

Contemporary Clinical Trials Volume 83 Pages 1-128 (August 2019) https://www.sciencedirect.com/journal/contemporary-clinical-trials/vol/83/suppl/C [Reviewed earlier] Current Genetic Medicine Reports Volume 7, Issue 3, September 2019 https://link.springer.com/journal/40142/7/3 Counseling and Testing (C Reiser and C Walton, Section Editors) Topical Collection Biobanks in the Era of Genomic Data Biobank research brings together participants, their samples and data, and researchers to provide a productive and efficient resource that advances discovery, prevention, diagnosis, and treatment. This mini-review addresses the importance of governance issues regarding consent, privacy and confidentiality, data sharing, and return of results in biobanks that utilize genomic sequencing data. Juliann Savatt, Cassandra J. Pisieczko, Yanfei Zhang Current Opinion in Infectious Diseases October 2019 - Volume 32 - Issue 5 https://journals.lww.com/co-infectiousdiseases/pages/currenttoc.aspx [Reviewed earlier] Developing World Bioethics Volume 19, Issue 3 Pages: 123-185 September 2019 https://onlinelibrary.wiley.com/toc/14718847/current ARTICLES ‘Bioethical Realism’: A Framework for Implementing Universal Research Ethics Implementation of existing ethical guidelines for international collaborative medical and health research is still largely controversial in sub‐Saharan Africa for two major reasons: One, they are seen as foreign and allegedly inconsistent with what has been described as an ‘African worldview’, hence, demand for their strict implementations reeks of ‘bioethical imperialism’. Two, they have other discernible inadequacies – lack of sufficient detail, apparent as well as real ambiguities, vagueness and contradictions. Similar charges exist(ed) in other non‐Western societies. Consequently, these guidelines have been correctly judged as an inadequate response to the complex and ever shifting dilemmas met by researchers and research regulators in the field. This paper proposes a framework for effective implementation of existing guidelines without much worry about bioethical imperialism and other inadequacies… John Barugahare Pages: 128-138 First Published: 06 August 2018 Putting placebo‐controlled trials in developing countries to the interpersonal justifiability test

Jamie Webb Pages: 139-147 First Published: 18 September 2018 Development in Practice Volume 29, Issue 7, 2019 http://www.tandfonline.com/toc/cdip20/current [Reviewed earlier]

Disasters Volume 43, Issue 3 Pages: 457-708 July 2019 https://onlinelibrary.wiley.com/toc/14677717/current [Reviewed earlier] EMBO Reports Volume 20 Issue 9 1 September 2019 https://www.embopress.org/toc/14693178/current Science & Society 5 August 2019 Characterizing scientific failure : Putting the replication crisis in context Stephan Guttinger, Alan C Love A better understanding of the nature and causes of failure in research could inform policies to improve the reproducibility of biomedical research. Emerging Infectious Diseases Volume 25, Number 9—September 2019 http://wwwnc.cdc.gov/eid/ [Reviewed earlier] Epidemics Volume 28 September 2019 https://www.sciencedirect.com/journal/epidemics/vol/28/suppl/C [Reviewed earlier] Epidemiology and Infection Volume 147 - 2019 https://www.cambridge.org/core/journals/epidemiology-and-infection/latest-issue [Reviewed earlier] Ethics & Human Research Volume 41, Issue 3 May-June 2019 https://onlinelibrary.wiley.com/toc/25782363/2019/41/3

Research Burdens, Benefits, and Risks [Reviewed earlier] The European Journal of Public Health Volume 29, Issue 4, August 2019 https://academic.oup.com/eurpub/issue/29/4 [Reviewed earlier] Genome Medicine https://genomemedicine.biomedcentral.com/articles [Accessed 14 Sep 2019] [No new digest content identified] Global Health Action Volume 11, 2018 – Issue 1 https://www.tandfonline.com/toc/zgha20/11/1?nav=tocList [Reviewed earlier]

Global Health: Science and Practice (GHSP) June 2019 | Volume 7 | Number 2 http://www.ghspjournal.org/content/current [Reviewed earlier] Global Public Health Volume 14, 2019 Issue 10 http://www.tandfonline.com/toc/rgph20/current [Reviewed earlier] Globalization and Health http://www.globalizationandhealth.com/ [Accessed 14 Sep 2019] [No new digest content identified] Health Affairs Vol. 38, No. 9 September 2019 https://www.healthaffairs.org/toc/hlthaff/current Neighborhoods & Health, Medicaid & More [New issue; No new digest content identified] Health and Human Rights

Volume 21, Issue 1, June 2019 https://www.hhrjournal.org/volume-21-issue-1-june-2019/ Special Section on Global Health Fieldwork Ethics and Human Rights Special Section on Invoking Health and Human Rights in the United States [Reviewed earlier] Health Economics, Policy and Law Volume 14 - Issue 4 - October 2019 https://www.cambridge.org/core/journals/health-economics-policy-and-law/latest-issue [Reviewed earlier] Health Policy and Planning Volume 34, Issue 6, July 2019 https://academic.oup.com/heapol/issue/34/6 [Reviewed earlier] Health Research Policy and Systems http://www.health-policy-systems.com/content [Accessed 14 Sep 2019] Review | 13 September 2019 The unpredictable journeys of spreading, sustaining and scaling healthcare innovations: a scoping review Innovation has the potential to improve the quality of care and health service delivery, but maximising the reach and impact of innovation to achieve large-scale health system transformation remains understudied. Interest is growing in three processes of the innovation journey within health systems, namely the spread, sustainability and scale-up (3S) of innovation. Recent reviews examine what we know about these processes. However, there is little research on how to support and operationalise the 3S. This study aims to improve our understanding of the 3S of healthcare innovations Authors: Élizabeth Côté-Boileau, Jean-Louis Denis, Bill Callery and Meghan Sabean Humanitarian Exchange Magazine Number 75, May 2019 https://odihpn.org/magazine/making-humanitarian-action-work-for-women-and-girls/ Special Feature: Making humanitarian action work for women and girls by HPN May 2019 The theme of this edition of Humanitarian Exchange, co-edited with Women Deliver, is making humanitarian action work for women and girls. Despite gains, including commitments made at the World Humanitarian Summit, there is still much to be done to address the gendered impacts of humanitarian crises and improve gender-sensitive humanitarian action. In the lead article, Jacqueline Paul advocates for feminist humanitarian action based on evidence that improvements in women’s socio-economic status can reduce excess mortality

among women after shocks. Jean Kemitare, Juliet Were and Jennate Eoomkham look at the role of local women’s rights organisations in preventing and responding to violence against women and girls, and Marcy Hersh and Diana Abou Abbas highlight opportunities for more concrete action on sexual and reproductive health in emergencies. Citing experience from Vanuatu, Jane Newnham explains how women will choose to use contraceptives even during a humanitarian response, when services and counselling are delivered in an appropriate and responsive way. Drawing on experience in Bangladesh, Tamara Fetters and colleagues challenge the belief that abortion is a non-essential service, or too complicated for humanitarian actors to provide. Darcy Ataman, Shannon Johnson, Justin Cikuru and Jaime Cundy reflect on an innovative programme using music therapy to help survivors of trauma. Emilie Rees Smith, Emma Symonds and Lauryn Oates highlight lessons from the STAGE education programme in Afghanistan, and Degan Ali and Deqa Saleh outline how African Development Solutions is helping women and girls take on leadership and decision-making roles in Somalia. Fiona Samuels and Taveeshi Gupta explore patterns of suicide among young people in Vietnam, with a particular focus on girls, and Subhashni Raj, Brigitte Laboukly and Shantony Moli illustrate the importance of a gendered approach to community-based disaster risk reduction in the South-West Pacific. Nicola Jones, Workneh Yadete and Kate Pincock draw on research in Ethiopia to explore the gender- and age-specific vulnerabilities of adolescents. The edition ends with an article by Julie Rialet-Cislaghi on how humanitarian responses can better address child marriage. Human Vaccines & Immunotherapeutics (formerly Human Vaccines) Volume 15, Issue 7-8, 2019 http://www.tandfonline.com/toc/khvi20/current Special Issues: HPV vaccination: from seroprevalence to public health policy and everything in between [80+ articles in edition focused on NPV vaccine; sample articles be]ow] [Reviewed earlier] Infectious Agents and Cancer http://www.infectagentscancer.com/content [Accessed 14 Sep 2019] [No new digest content identified] Infectious Diseases of Poverty http://www.idpjournal.com/content [Accessed 14 Sep 2019] Commentary | 13 September 2019 The role of multilateral organizations and governments in advancing social innovation in health care delivery

Despite great medical advances and scientific progress over the past century, one billion people globally still lack access to basic health care services. In the context of the 2030 Agenda for Sustainable Development social innovation models aim to provide effective solutions that bridge the health care delivery gap, address equity and create social value. This commentary highlights the roles of multilateral organizations and governments in creating an enabling environment where social innovations can more effectively integrate into health systems to maximize their impact on beneficiaries. Authors: Beatrice Halpaap, Rosanna W. Peeling and François Bonnici International Health Volume 11, Issue 4, July 2019 http://inthealth.oxfordjournals.org/content/current [Reviewed earlier] International Journal of Community Medicine and Public Health Vol 6, No 7 (2019) July 2019 https://www.ijcmph.com/index.php/ijcmph/issue/view/52 [Reviewed earlier] International Journal of Epidemiology Volume 48, Issue 4, August 2019 https://academic.oup.com/ije/issue/48/4 [Reviewed earlier] International Journal of Human Rights in Healthcare Volume 12 Issue 3 2019 https://www.emeraldinsight.com/toc/ijhrh/12/3 [Reviewed earlier] International Journal of Infectious Diseases August 2019 Volume 85, p1-214 https://www.ijidonline.com/issue/S1201-9712(19)X0011-9 [Reviewed earlier] JAMA September 10, 2019, Vol 322, No. 10, Pages 903-1022 http://jama.jamanetwork.com/issue.aspx Research Letter Prevalence of Oral HPV Infection in Unvaccinated Men and Women in the United States, 2009-2016 Anil K. Chaturvedi, PhD; Barry I. Graubard, PhD; Tatevik Broutian, PhD; et al. JAMA. 2019;322(10):977-979. doi:10.1001/jama.2019.10508

To estimate changes in oral human papillomavirus (HPV) prevalence attributable to vaccination vs herd immunity, this national survey study uses National Health and Nutrition Examination Survey data to compare oral HPV prevalence for 4 types targeted by HPV vaccine and 33 nonvaccine types in unvaccinated US adults aged 18 to 59 years from 2009 to 2016. Viewpoint Scientific Discovery and the Future of Medicine Accelerating the Science of SCD Therapies—Is a Cure Possible? Edward J. Benz Jr, MD; Traci Heath Mondoro, PhD; Gary H. Gibbons, MD JAMA. 2019;322(10):921-922. doi:10.1001/jama.2019.11419 This Viewpoint reviews the molecular basis of sickle cell disease (SCD), the history of treatments for the disease, and recent progress toward curative therapies including HSCT and gene therapy and editing, emphasizing that research and innovation needs to take into account patient priorities and perspectives given the history of research mistreatment of minority groups most affected by SCD. CAR T-Cell TherapyA Microcosm for the Challenges Ahead in Medicare Caron Jacobson, MD; Amy Emmert, MScPH; Meredith B. Rosenthal, PhD JAMA. 2019;322(10):923-924. doi:10.1001/jama.2019.10194 This Viewpoint discusses existing mechanisms of Medicare reimbursement for chimeric antigen receptor (CAR) T-cell therapy, which at US $375 000 to $475 000 per treatment is prohibitively expensive, and proposes ways to mitigate the challenges of covering the therapy appropriately and equitably for those who need it while realistically managing cost constraints. JAMA Pediatrics September 2019, Vol 173, No. 9, Pages 807-900 http://archpedi.jamanetwork.com/issue.aspx [Reviewed earlier] JBI Database of Systematic Review and Implementation Reports September 2019 - Volume 17 - Issue 9 http://journals.lww.com/jbisrir/Pages/currenttoc.aspx EDITORIALS Prioritizing impact to improve health services and reduce inequities in rural, remote and very remote locations Carey, Timothy A. JBI Database of Systematic Reviews and Implementation Reports. 17(9):1729-1730, September 2019. Journal of Adolescent Health September 2019 Volume 65, Issue 3, p309-432 https://www.jahonline.org/issue/S1054-139X(18)X0011-1 [New issue; No digest content identified]

Journal of Community Health Volume 44, Issue 5, October 2019 https://link.springer.com/journal/10900/44/5 [Reviewed earlier] Journal of Development Economics Volume 140 Pages 1-374 (September 2019) https://www.sciencedirect.com/journal/journal-of-development-economics/vol/140/suppl/C [Reviewed earlier] Journal of Empirical Research on Human Research Ethics Volume 14 Issue 4, October 2019 http://journals.sagepub.com/toc/jre/current Empirical studies on informed consent Concise Consent Forms Appreciated—Still Not Comprehended: Applying Revised Common Rule Guidelines in Online Studies Evan K. Perrault, Seth P. McCullock First Published June 6, 2019; pp. 299–306 Attitudes Regarding Enrollment in a Genetic Research Project: An Informed Consent Simulation Study Comparing Views of People With Depression, Diabetes, and Neither Condition Jane Paik Kim, Katie Ryan, Laura Weiss Roberts First Published July 22, 2019; pp. 328–337 Empirical studies of IRB/REC functioning Improving Compliance With Institutional Review Board Continuing Review Requirements Min-Fu Tsan, Yen Nguyen First Published March 20, 2019; pp. 365–37 Journal of Epidemiology & Community Health September 2019 - Volume 73 - 9 https://jech.bmj.com/content/73/9 [New issue; No digest content identified] Journal of Evidence-Based Medicine Volume 12, Issue 3 Pages: 185-231 August 2019 https://onlinelibrary.wiley.com/toc/17565391/current [Reviewed earlier] Journal of Global Ethics Volume 15, Issue 2, 2019

http://www.tandfonline.com/toc/rjge20/current Selected papers of the 2018 meetings of International Development Ethics Association & Groupe de Recherche en Economie Théorique et Appliquée [Reviewed earlier] Journal of Health Care for the Poor and Underserved (JHCPU) Volume 30, Number 2, May 2019 https://muse.jhu.edu/issue/40369 [Reviewed earlier] Journal of Immigrant and Minority Health Volume 21, Issue 5, October 2019 https://link.springer.com/journal/10903/21/5 [New issue; No digest content identified] Journal of Immigrant & Refugee Studies Volume 17, 2019 Issue 4 https://www.tandfonline.com/toc/wimm20/current [New issue; No digest content identified] Journal of Infectious Diseases Volume 220, Issue 6, 15 September 2019 https://academic.oup.com/jid/issue/220/6 [Reviewed earlier] Journal of Medical Ethics September 2019 - Volume 45 - 9 http://jme.bmj.com/content/current Original research Meeting the needs of underserved populations: setting the agenda for more inclusive citizen science of medicine (12 July, 2019) In its expansion to genomic, epidemiological and biomedical research, citizen science has been promoted as contributing to the democratisation of medical research and healthcare. At the same time, it has been criticised for reinforcing patterns of exclusion in health and biomedicine, and sometimes even creating new ones. Although citizen science has the potential to make biomedical research more inclusive, the benefits of current citizen science initiatives are not equally accessible for all people—in particular those who are resource-poor, located outside of traditional networks of healthcare services, or members of minorities and marginalised groups. Amelia Fiske, Barbara Prainsack, Alena Buyx Journal of Patient-Centered Research and Reviews Volume 6, Issue 3 (2019)

https://digitalrepository.aurorahealthcare.org/jpcrr/ [Reviewed earlier] Journal of the Pediatric Infectious Diseases Society (JPIDS) Volume 8, Issue 3, September 2019 https://academic.oup.com/jpids/issue [Reviewed earlier] Journal of Pediatrics September 2019 Volume 212, p1-254 http://www.jpeds.com/current [Reviewed earlier] Journal of Pharmaceutical Policy and Practice https://joppp.biomedcentral.com/ [Accessed 14 Sep 2019] Review | 11 September 2019 Regulatory framework in Pakistan: situation analysis of medicine quality and future recommendations Quality issues in pharmaceuticals are identified as a huge global and public health problem, especially with reference to low- and middle-income countries like Pakistan. The 2011 “Fake Drug Crisis” acted as a driving force to reform the regulatory structures of the country and for establishing the autonomous “Drug Regulatory Authority of Pakistan”. Despite the fact that Pakistan possesses a huge pharmaceutical industry, there is a severe dearth of published literature and scientific evidence for the country regarding medicine quality and the prevalence of counterfeit and low-quality products, respectively. Authors: Huma Rasheed, Ludwig Hoellein, Khalid Saeed Bukhari and Ulrike Holzgrabe Journal of Public Health Management & Practice September/October 2019 - Volume 25 - Issue 5 https://journals.lww.com/jphmp/pages/currenttoc.aspx [Reviewed earlier] Journal of Public Health Policy Volume 40, Issue 3, September 2019 https://link.springer.com/journal/41271/40/3 [New issue; No digest content identified] Journal of Refugee & Global Health Volume 2, Issue 2 (2019) https://ir.library.louisville.edu/rgh/

[Reviewed earlier] Journal of the Royal Society – Interface 7 August 2019 Volume 16 Issue 157 https://royalsocietypublishing.org/toc/rsif/current [Reviewed earlier] Journal of Travel Medicine Volume 26, Issue 6, 2019 https://academic.oup.com/jtm/issue/26/6 [Reviewed earlier] Journal of Virology September 2019; Volume 93,Issue 17 http://jvi.asm.org/content/current [Reviewed earlier] The Lancet Sep 14, 2019 Volume 394 Number 10202 p895-978 https://www.thelancet.com/journals/lancet/issue/current Editorial Tuberculosis needs accelerated and continued attention The Lancet Series Tuberculosis 2019 Management of drug-resistant tuberculosis Christoph Lange, Keertan Dheda, Dumitru Chesov, Anna Maria Mandalakas, Zarir Udwadia, C Robert Horsburgh Jr Tuberculosis 2019 Challenges and controversies in childhood tuberculosis Anja Reuter, Jennifer Hughes, Jennifer Furin The Lancet Child & Adolescent Health Sep 2019 Volume 3 Number 9 p585-662 https://www.thelancet.com/journals/lanchi/issue/current [Reviewed earlier] Lancet Digital Health Sep 2019 Volume 1 Number 5e193-e242 https://www.thelancet.com/journals/landig/issue/current

[Reviewed earlier] Lancet Global Health Sep 2019 Volume 7Number 9e1147-e1286 http://www.thelancet.com/journals/langlo/issue/current [Reviewed earlier] Lancet Infectious Diseases Sep 2019 Volume 19Number 9p915-1034, e301-e336 http://www.thelancet.com/journals/laninf/issue/current [Reviewed earlier] Lancet Respiratory Medicine Sep 2019 Volume 7 Number 9 p721-826, e26-e28 http://www.thelancet.com/journals/lanres/issue/current [Reviewed earlier] Maternal and Child Health Journal Volume 23, Issue 9, September 2019 https://link.springer.com/journal/10995/23/8 [Reviewed earlier] Medical Decision Making (MDM) Volume 39 Issue 4, May 2019 http://mdm.sagepub.com/content/current [Reviewed earlier] The Milbank Quarterly A Multidisciplinary Journal of Population Health and Health Policy Volume 97, Issue 2 Pages: 369-619 June 2019 https://onlinelibrary.wiley.com/toc/14680009/current [Reviewed earlier] Nature Volume 573 Issue 7773, 12 September 2019 http://www.nature.com/nature/current_issue.html [New issue; No digest content identified] Nature Biotechnology Volume 37 Issue 9, September 2019

https://www.nature.com/nbt/volumes/37/issues/9 [Reviewed earlier] Nature Genetics Volume 51 Issue 9, September 2019 https://www.nature.com/ng/volumes/51/issues/9 [Reviewed earlier] Nature Medicine Volume 25 Issue 9, September 2019 https://www.nature.com/nm/volumes/25/issues/8 Editorial | 09 September 2019 Delivering the promise of RNA therapeutics As the clinical potential of RNA therapeutics begins to be unveiled, expanding the range of tissue types that can be targeted for delivery of these drugs is now the main hurdle to overcome. Review Article | 09 September 2019 Clinical lessons learned from the first leg of the CAR T cell journey Clinical application of CAR T cells to cancer therapy has met with much success, but future trials must build on current understanding to overcome therapy resistance Robbie G. Majzner & Crystal L. Mackall Nature Reviews Genetics Volume 20 Issue 9, September 2019 https://www.nature.com/nrg/volumes/20/issues/9 [Reviewed earlier] Nature Reviews Immunology Volume 19 Issue 9, September 2019 https://www.nature.com/nri/volumes/19/issues/9 Review Article | 21 May 2019 Moving tuberculosis vaccines from theory to practice V accine trials against Mycobacterium tuberculosis (Mtb) are showing encouraging results. This Review discusses current Mtb vaccine design in the light of new insights into the immunology of tuberculosis infection. Peter Andersen & Thomas J. Scriba New England Journal of Medicine September 12, 2019 Vol. 381 No. 11 http://www.nejm.org/toc/nejm/medical-journal [New issue; No digest content identified]

Pediatrics September 2019, VOLUME 144 / ISSUE 3 https://pediatrics.aappublications.org/content/144/3?current-issue=y [Reviewed earlier] Pharmaceutics Volume 11, Issue 8 (August 2019) https://www.mdpi.com/1999-4923/11/8 [Reviewed earlier] PharmacoEconomics Volume 37, Issue 9, September 2019 https://link.springer.com/journal/40273/37/9 [Reviewed earlier] PLoS Genetics https://journals.plos.org/plosgenetics/ (Accessed 14 Sep 2019) [No new digest content identified] PLoS Medicine http://www.plosmedicine.org/ (Accessed 14 Sep 2019) [No new digest content identified] PLoS Neglected Tropical Diseases http://www.plosntds.org/ (Accessed 14 Sep 2019) [No new digest content identified] PLoS One http://www.plosone.org/ [Accessed 14 Sep 2019] [No new digest content identified] PLoS Pathogens http://journals.plos.org/plospathogens/ [Accessed 14 Sep 2019] [No new digest content identified]

PNAS - Proceedings of the National Academy of Sciences of the United States of America http://www.pnas.org/content/early/ [Accessed 14 Sep 2019] [No new digest content identified] Prehospital & Disaster Medicine Volume 34 - Issue 4 - August 2019 https://www.cambridge.org/core/journals/prehospital-and-disaster-medicine/latest-issue [Reviewed earlier] Preventive Medicine Volume 126 September 2019 https://www.sciencedirect.com/journal/preventive-medicine/vol/125/suppl/C [Reviewed earlier] Proceedings of the Royal Society B 21 August 2019 Volume 286 Issue 1909 https://royalsocietypublishing.org/toc/rspb/current [Reviewed earlier] Public Health Volume 174 Pages A1-A2, 1-154 (September 2019) https://www.sciencedirect.com/journal/public-health/vol/174/suppl/C [New issue; No digest content identified] Public Health Ethics Volume 12, Issue 2, July 2019

http://phe.oxfordjournals.org/content/current [Reviewed earlier] Public Health Reports Volume 134 Issue 5, September/October 2019 [Reviewed earlier] Qualitative Health Research Volume 29 Issue 11, September 2019 http://qhr.sagepub.com/content/current [Reviewed earlier]

Research Ethics Volume 15 Issue 2, April 2019 http://journals.sagepub.com/toc/reab/current [Reviewed earlier] Reproductive Health http://www.reproductive-health-journal.com/content [Accessed 14 Sep 2019] [No new digest content identified] Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH) http://www.paho.org/journal/index.php?option=com_content&view=featured&Itemid=101 [No new digest content identified] Risk Analysis Volume 39, Issue 9 Pages: 1867-2116 September 2019 https://onlinelibrary.wiley.com/toc/15396924/current Special Issue: Resilient Cyber‐Physical‐Social Systems [New issue; No digest content identified] Risk Management and Healthcare Policy https://www.dovepress.com/risk-management-and-healthcare-policy-archive56 [Accessed 14 Sep 2019] [No new digest content identified] Science 13 September 2019 Vol 365, Issue 6458 http://www.sciencemag.org/current.dtl Special Issue: Mountain Life [New issue; No digest content identified] Science Translational Medicine 11 September 2019 Vol 11, Issue 509 https://stm.sciencemag.org/ [New issue; No digest content identified] Social Science & Medicine Volume 236 September 2019 https://www.sciencedirect.com/journal/social-science-and-medicine/vol/236/suppl/C

Review article Abstract only Social capital and physical health: An updated review of the literature for 2007–2018 Justin Rodgers, Anna V. Valuev, Yulin Hswen, S.V. Subramanian Article 112360 Systematic Reviews https://systematicreviewsjournal.biomedcentral.com/articles [Accessed 14 Sep 2019] [No new digest content identified] Travel Medicine and Infectious Diseases Volume 30 Pages 1-148 (July–August 2019) https://www.sciencedirect.com/journal/travel-medicine-and-infectious-disease/vol/30/suppl/C [Reviewed earlier] Tropical Medicine & International Health Volume 24, Issue 9 Pages: i-iv, 1031-1137 September 2019 https://onlinelibrary.wiley.com/toc/13653156/current [Reviewed earlier] Vaccine Volume 37, Issue 40 Pages 5909-6016 (20 September 2019) https://www.sciencedirect.com/journal/vaccine/vol/37/issue/40 Conference info Open access The art of partnerships for vaccines Sonia Pagliusi, Yanchun Che, Shaozhong Dong Pages 5909-5919 Commentary Discussion Abstract only Broadening the perspective on gender equity in immunization: The unique contributions of Human Papillomavirus vaccination Marta Feletto, Alyssa B. Sharkey Pages 5920-5922 Review article Abstract only Pharmacist role in vaccination: Evidence and challenges Arjun Poudel, Esther T.L. Lau, Megan Deldot, Chris Campbell, ... Lisa M. Nissen Pages 5939-5945 Review article Abstract only Cost-benefit analysis of a national influenza vaccination program in preventing hospitalisation costs in Australian adults aged 50–64 years old

Suresh Mahendra Raj, Abrar Ahmad Chughtai, Anurag Sharma, Timothy C. Tan, C. Raina MacIntyre Pages 5979-5985 Review article Abstract only The mad leading the blind: Perceptions of the vaccine-refusal movement among Australians who support vaccination T. Rozbroj, A. Lyons, J. Lucke Pages 5986-5993 Review article Abstract only Timeliness of rotavirus vaccination at sentinel sites in four early-adopter African countries Talia Pindyck, Jacqueline E. Tate, Isidore Juste O. Bonkoungou, George Armah, ... Umesh Parashar Pages 6002-6007 Review article Abstract only Trust in vaccines and medicines in Uganda Daniel R. Evans, Tatenda T. Yemeke, Elizabeth E. Kiracho, Aloysius Mutebi, ... Sachiko Ozawa Pages 6008-6015 Vaccines — Open Access Journal http://www.mdpi.com/journal/vaccines (Accessed 14 Sep 2019) Open Access Review The Cellular Immune Response to Rabies Vaccination: A Systematic Review by Lisanne A. Overduin, Jacques J.M. van Dongen and Leonardus G. Visser Vaccines 2019, 7(3), 110; https://doi.org/10.3390/vaccines7030110 - 11 Sep 2019 Abstract The effectiveness of rabies vaccines is conventionally determined by serological testing. In addition to this assessment of humoral immunity, cellular immunity could help assess effectiveness and protection through a broad range of parameters. Therefore, this study aimed to systematically review all literature on the kinetics and composition of the cellular immune response to rabies vaccination in humans. A total of 1360 studies were identified in an extensive literature search. Twenty studies were selected for inclusion. In a primary response, plasma cells are detectable from day 7 to day 14, peaking at day 10. Memory B-cells appear from day 10 up to at least day 28. After revaccination, natural killer (NK) cells are the first detectable cellular parameters. Further research is required to assess cellular parameters in relation to long-term (serological) immunity. This review was registered in the International Prospective Register of Systematic Reviews (PROSPERO) under registration number CRD42019134416. Value in Health September 2019 Volume 22, Issue 9, p975-1082 https://www.valueinhealthjournal.com/issue/S1098-3015(19)X0009-1

[New issue; No digest content identified] Viruses Volume 11, Issue 8 (August 2019) https://www.mdpi.com/1999-4915/11/8 [Reviewed earlier]

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From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary Journal of Adolescent Health Available online 9 September 2019 In Press, Corrected Proof Original article Declines in vaccine-type human papillomavirus prevalence in females across racial/ethnic groups: data from a national survey NM McClung, RM Lewis, JW Gargano, T Querec… Conclusions Within 10 years of vaccine introduction, 4vHPV-type prevalence declined 86% among 14- to 19-year-olds, with declines observed in NHW, NHB, and MA females, and 71% among 20- to 24-year-olds, with declines in NHW and NHB females. These extraordinary declines should lead to substantial reductions in HPV-associated cancers. Eurosurveillance Volume 24, Issue 36, 05/ Sep/2019 Research Open Access Promoting vaccination in maternity wards ─ motivational interview technique reduces hesitancy and enhances intention to vaccinate, results from a multicentre non-controlled pre- and post-intervention RCT-nested study, Quebec, March 2014 to February 2015 A Gagneur, MC Battista, FD Boucher, B Tapiero… -

Journal of Cancer Education First Online: 07 September 2019 Article Rural Caregivers' Willingness for Community Pharmacists to Administer the HPV Vaccine to Their Age-Eligible Children AM Koskan, LN Dominick, DL Helitzer - Abstract

Human papillomavirus (HPV) vaccination uptake varies by geographic regions with rural, often medically underserved areas, lagging behind more urban regions in terms of vaccine initiation and completion. In these regions, pharmacies may serve as an additional location for HPV vaccine administration. Little is known about rural caregivers’ willingness to have their HPV vaccine age-eligible children obtain this vaccine from their local pharmacist. First and second authors conducted 26 in-depth interviews with caregivers of HPV vaccine age-eligible children living in rural regions of a southwestern state to explore their perceptions of the HPV vaccine and their willingness for pharmacist-administered HPV vaccination. They analyzed interview data using an inductive qualitative content analyses approach. The majority of caregivers were unaware that pharmacists could offer adolescent vaccines. However, most were willing to allow their children to receive the vaccine from this non-traditional source. Comments related to obtaining vaccinations from pharmacists related mostly to concerns about proper training and their certification to vaccinate against HPV. Caregivers believed that having a pharmacist administer the HPV vaccine would not affect their relationship with their primary care provider. Caregivers preferred print health education resources and were interested in also receiving health information via social media to learn more about the HPV vaccine and pharmacists’ role in HPV vaccine administration. Pharmacies may serve as an additional site to increase HPV vaccine initiation and completion. Rural regions need additional health information about the HPV vaccine and pharmacists’ abilities to administer this cancer prevention resource. * * * *

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 14 Sep 2019 [No new, unique, relevant content] BBC http://www.bbc.co.uk/ Accessed 14 Sep 2019 Malaria vaccine in Kenya - a potential game-changer 13 Sep 2019

The world's first malaria vaccine is being rolled out in parts of Kenya from Friday, after previously being released in Ghana and Malawi. It will be added to the routine vaccination schedule, and more than 300,000 children are expected to receive the vaccine over the next three years. Malaria kills more than 400,000 people globally each year - mostly children - making this vaccine a potential game-changer, as Global Health Correspondent Tulip Mazumdar reports. The Economist http://www.economist.com/ Accessed 14 Sep 2019 [No new, unique, relevant content] Financial Times http://www.ft.com/home/uk Accessed 14 Sep 2019 [No new, unique, relevant content] Forbes http://www.forbes.com/ Accessed 14 Sep 2019 [No new, unique, relevant content] Foreign Affairs http://www.foreignaffairs.com/ Accessed 14 Sep 2019 [No new, unique, relevant content] Foreign Policy http://foreignpolicy.com/ Accessed 14 Sep 2019 [No new, unique, relevant content] The Guardian http://www.guardiannews.com/ Accessed 14 Sep 2019 Global health Hundreds of children die in Philippine dengue epidemic as local action urged Health ministry calls for greater efforts to deal with mosquito-borne disease at village level as death toll reaches four figures… The government fears cases could rise further as the country enters typhoon season. Following a national ban on a controversial vaccine blamed for children’s deaths, cases of dengue fever in the Philippines have more than doubled compared with figures for the same period last year. The Department for Health has recorded 249,332 cases since the start of the year, dwarfing the 119,224 cases recorded in 2018. The figures are the highest since 2012. The government is considering appeals to lift its ban on Dengvaxia, a drug developed by French pharmaceutical firm Sanofi Pasteur that remains the only vaccine available against dengue. However, many remain cautious due to claims that improper use in the country had led

to children’s deaths. The World Health Organization issued a conditional recommendation for the vaccine in areas where dengue is highly endemic… Protesters shut down California's legislature as bills tighten vaccine bills 4 days ago ... Activists shut down both chambers of the California state legislature with protests and chanting against a set of bills seeking to tighten school .. New Yorker http://www.newyorker.com/ Accessed 14 Sep 2019 [No new, unique, relevant content] New York Times http://www.nytimes.com/ Accessed 14 Sep 2019 New York How Far Would You Go to Avoid Vaccinating Your Child? In New York, as new immunization laws take effect, there has been a surge in parents home schooling their children. By Ginia Bellafante Health Lasker Awards Honor Advances in Modern Immunology The prizes recognized the discoverers of B and T lymphocytes, pioneers in genetic engineering to fight breast cancer, and a nonprofit that helps get vaccines to the world’s poorest children. Sept. 10 By Knvul SheikhU.S. U.S. California Governor Signs Vaccine Bills He Demanded California Gov. Gavin Newsom signed bills Monday to crack down on doctors who write fraudulent medical exemptions for school children's vaccinations. Sept. 9 By The Associated Press Washington Post http://www.washingtonpost.com/ Accessed 14 Sep 2019 Health California’s governor signed a pro-vaccine bill into law this week. Then the protests got weird. By Marisa Iati September 14 at 4:05 PM Anti-vaccine activists in California area heatedly protesting new limits on medical exemptions to vaccine requirements days after the bill was finalized amid a nationwide crisis of confidence in the life-saving procedure. First, protesters blocked the entrance to the state capitol Monday and repeatedly shut down the legislature with their demonstrations as Gov. Gavin Newsom (D) signed the bill, the San Francisco Chronicle reported.

Then, a candlelight vigil Wednesday for children allegedly harmed or killed by vaccines included a photo of Ethan Lindenberger, who was vaccinated against his parents’ wishes and has testified before Congress. Jonathan Lockwood, executive director of the anti-vaccine group Conscience Coalition, which organized the vigil, did not immediately respond to a question about why the photo was used. The state legislative session closed Friday with a dramatic display from the gallery: A woman threw “a feminine hygiene device containing what appeared to be blood” at the senators from a balcony, the California Highway Patrol said… * * * *

Think Tanks et al Brookings http://www.brookings.edu/ Accessed 14 Sep 2019 Future Development Are the multilaterals ready to act on pandemic prevention and other global public goods? Kaci Kennedy McDade and Gavin Yamey Wednesday, September 11, 2019 Center for Global Development http://www.cgdev.org/page/press-center September 12, 2019 Reflections on 15 Years of “Market Shaping”: The Case of the Pentavalent Vaccine Over the past two decades, several global health institutions have attempted to improve public health by influencing the characteristics of health product markets, including pricing, quality, overall production, and the supplier and product landscapes. We examine the role of Gavi, the Vaccine Alliance in market shaping. Rachel Silverman CSIS https://www.csis.org/ Accessed 14 Sep 2019 Commentary The Ebola Virus Is Winning in Eastern Democratic Republic of the Congo September 12, 2019 | By J. Stephen Morrison Hard barriers to access lie at the very heart of the agonizing struggle by international and Congolese responders to contain and ultimately arrest the Ebola outbreak in eastern Democratic Republic of the Congo (DRC). As of early September 2019, there have been over 3,000 cases and 2,000 deaths. Foremost among the barriers to access are insecurity and chaos, which gravely and consistently thwart access to the hot zone, in effect providing shelter for the virus. Four other forces contribute profoundly to creating an environment in which it has not been possible to confront and circumnavigate DRC’s insecurity and chaos in order to carry out the public health actions essential to end the Ebola outbreak. These compounding factors include DRC’s dysfunctional governance, the absence of high-level major power engagement, the

overload created by DRC’s high number of infectious disease outbreaks amid a roiling humanitarian crisis, and the flawed implementation and management of an underfinanced international response… Council on Foreign Relations http://www.cfr.org/ Accessed 14 Sep 2019 [No new relevant content] Kaiser Family Foundation https://www.kff.org/search/?post_type=press-release Accessed 14 Sep 2019 [No new relevant content] * * * * * * * * Vaccines and Global Health: The Week in Review is a service of the Center for Vaccine Ethics and Policy (CVEP)/GE2P2 Global, which is solely responsible for its content, and is an open access publication, subject to the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc/3.0/). Copyright is retained by CVEP. CVEP is a program of the GE2P2 Global Foundation – whose purpose and mission is to advance ethical and scientific rigor in research and evidence generation for governance, policy and practice in health, human rights action, humanitarian response, heritage stewardship, education and sustainable development. The Foundation serves governments, international agencies, INGOs, civil society organizations (CSOs), commercial entities, consortia and alliances. CVEP maintains an academic affiliation with the Division of Medical Ethics, NYU School of Medicine, and an operating affiliation with the Vaccine Education Center of Children’s Hospital of Philadelphia [CHOP].

Support for this service is provided by the Bill & Melinda Gates Foundation; PATH, and industry resource members Janssen/J&J, Pfizer, Sanofi Pasteur U.S.,Takeda, Moderna Therapeutics (list in formation), and the Developing Countries Vaccine Manufacturers Network (DCVMN).

Support is also provided by a growing list of individuals who use this membership service to support their roles in public health, clinical practice, government, NGOs and other international institutions, academia and research organizations, and industry. * * * * * * * *