WHO & Regional Offices [to 18 Jan 2020]

WHO & Regional Offices [to 18 Jan 2020]
17 January 2020 News release
From political commitment to concrete reality: moving ahead on UHC in 2020

17 January 2020 News release
Lack of new antibiotics threatens global efforts to contain drug-resistant infections

13 January 2020 News release
WHO statement on novel coronavirus in Thailand

 

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Weekly Epidemiological Record, 17 January 2020, vol. 95, 03 (pp. 13–24)
Report of the third Global Forum of Malaria-eliminating Countries, 18–20 June 2019, Wuxi, China

 

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WHO African Regions Immunization Technical Advisory Group (RITAG)
:: Call for nominations pdf, 147kb Deadline for applications: 28 February 2020
:: RITAG Terms of Reference pdf, 211kb
:: RITAG application annexes pdf, 91kb

 

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GIN November and December 2019 pdf, 2.83Mb
13 January 2020

 

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Three African countries halt polio outbreaks 20 December 2019
Kenya, Mozambique and Niger have curbed polio outbreaks that erupted in different episodes over the past 24 months, allowing them to regain their polio-free status, World Health Organization (WHO) announced today.
:: WHO unveils plan to tackle rising HIV drug resistance in Africa 06 December 2019
WHO and partners unveil a five-year plan to monitor, prevent and respond to growing HIV drug resistance in Africa. HIV drug resistance is threatening the significant progress made in the global fight against the virus.

WHO Region of the Americas PAHO
No new digest content identified.

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

WHO European Region EURO
:: WHO/Europe and Norway discuss improving affordable access to innovative medicines 16-01-2020
:: Violence against children: tackling hidden abuse 13-01-2020

WHO Eastern Mediterranean Region EMRO
:: WHO responds to urgent health needs in El Geneina, West Darfur 14 January 2020
:: WHO assesses hospital’s influenza preparedness in Erbil 14 January 2020

WHO Western Pacific Region
:: China virus outbreak shows Asia needs to step up infection preparation
Region is safer after epidemic lessons but new diseases always arising 15 January 2020

Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 18 Jan 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
Hodgkin lymphoma recruits and trains immune cells to help it thrive
January 14, 2020
Study also highlights possible new targets for treatment, how to better tailor cancer therapies for individual patients

 

BMGF – Gates Foundation [to 18 Jan 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 18 Jan 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 18 Jan 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.
01.13.2020
CARB-X funds Trellis Bioscience to support the development of a monoclonal antibody designed to disrupt superbugs’ protective coating so that antibiotics can kill them
CARB-X is awarding Trellis Bioscience, of Redwood City, California, USA, up to $3.2 million in non-dilutive funding, with the possibility of $3.8 million more if certain project milestones are met, to develop an innovative monoclonal antibody designed to disrupt the protective biofilm that makes bacteria resistant to antibiotics.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 18 Jan 2020]
http://cepi.net/
Latest news
Newly discovered coronavirus in Wuhan China
Our CEO, Richard Hatchett, discusses how the rapid publication of the genetic sequence of the newly discovered beta coronavirus could help speed up the development of diagnostic tests, case…
Blog 17 Jan 2020
[See Milestones above for detail]

 

Clinton Health Access Initiative, Inc. (CHAI) [to 18 Jan 2020]
https://clintonhealthaccess.org/
News & Press Releases
No new digest content identified.

 

EDCTP [to 18 Jan 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 18 Jan 2020]
http://www.vaccines.emory.edu/
No new digest content identified.

 

European Medicines Agency [to 18 Jan 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Mandatory use of international standard for the reporting of side effects to improve safety of medicines
Last updated: 15/01/2020
At its December 2019 meeting, EMA’s Management Board agreed to the mandatory use of a consistent international format, the ISO ICSR format, for reporting individual cases of suspected side effects in patients across the world. This follows a recommendation from EMA’s safety committee (PRAC) in October 2019. The use of the new international standard will become mandatory as of 30 June 2022 for all reporting to EudraVigilance, the European database of suspected side effects with medicines authorised in the European Economic Area (EEA).

The ISO ICSR standard is based on the ICH E2B(R3) modalities for the reporting of suspected side effects of medicines in individual case safety reports (ICSRs). Compared to the older reporting formats it improves the quality of data collected and increases the ability to search and analyse these data. This will better support regulatory authorities and companies to detect and address safety issues with medicines and therefore protect patients. In addition, the ISO standard strengthens personal data protection in the records of ICSRs collected by regulatory authorities and companies.

A guide , jointly developed by EMA and the Heads of Medicines Agencies (HMA), was published in 2015 to help pharmaceutical companies, sponsors of clinical trials and medicines regulatory authorities in EU Member States prepare for the use of the new standard. The guide specifically defines the electronic transmission process of ICSRs, the format and content of the ICSR, the business rules for report validation, as well as classification and data quality principles. It also assists software providers and IT developers in the development of pharmacovigilance and safety databases…

 

European Vaccine Initiative [to 18 Jan 2020]
http://www.euvaccine.eu/news-events
No new digest content identified.

 

FDA [to 18 Jan 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
No new digest content identified.

 

Fondation Merieux [to 18 Jan 2020]
http://www.fondation-merieux.org/
News, Events
The Malagasy Ministry of Education and Technical and Vocational training and the Mérieux Foundation sign an agreement to promote good health practices in schools
January 9, 2020 – Anosy, Antananarivo (Madagascar)
Her Excellency, Marie Thérèse Volahaingo, Minister of the Malagasy Ministry of Education and Technical and Vocational Training, and Luciana Rakotoarisoa, Manager of the Mérieux Foundation in Madagascar, have signed a partnership agreement for the distribution of health education kits throughout the country’s schools…

 

Gavi [to 18 Jan 2020]
https://www.gavi.org/
No new digest content identified.
GHIT Fund [to 18 Jan 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 18 Jan 2020]
https://www.theglobalfund.org/en/news/
News & Stories
Updates
Data Service: Country Coordinating Mechanism Contacts
17 January 2020

Updates
Data Explorer: Location Detail Pages
14 January 2020

 

Hilleman Laboratories [to 18 Jan 2020]
http://www.hillemanlabs.org/
News
Hilleman Laboratories Expands into Maternal and Child Health; Plans to Develop a Novel Vaccine Against Group B Streptococcus
16th January 2020, New Delhi: In a bid to strengthen its vaccine portfolio and expand into areas of unmet need, Hilleman Laboratories, a global research and development organization focused on delivering high-impact and affordable vaccines, announced today about plans to venture into the area of maternal and child health.

In this regard, Hilleman Labs is undertaking research and development of an effective and affordable vaccine against Group B Streptococcus to add a positive impact to women and children living in low middle-income countries.

Streptococcus agalactiae or group B streptococcus (GBS) is a leading cause of serious neonatal infections including septicaemia, pneumonia and less frequently meningitis, and urinary tract infections, chorioamnionitis, endometritis and bacteremia in women. GBS is an opportunistic commensal constituting a part of the intestinal and vaginal physiologic flora in almost 25% of healthy adult women. Maternal colonization is the principal route of GBS transmission. GBS converts from the asymptomatic mucosal carriage state to a major bacterial pathogen causing severe invasive infections…

Dr Davinder Gill, CEO, Hilleman Laboratories, said, “Hilleman Labs has embarked on a project to develop a safe, effective and affordable vaccine against Group B Streptococcus. In this project, we will use our expertise in the conjugate vaccine technology in which we have substantial experience. We will design, assemble and test the vaccine within our R&D centre in India.” We will pay close attention to Group B Streptococcus strains that are prevalent in India and South East Asia. Thereafter, we will partner with a vaccine manufacturing company for further development, manufacture and sale of the vaccine. Since there is currently no approved vaccine for Group B Streptococcus, our initiative is an important one for women and children living in low middle-income countries,” he added…

 

Human Vaccines Project [to 18 Jan 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.

 

IAVI [to 18 Jan 2020]
https://www.iavi.org/newsroom
January 14, 2020
IAVI Makes Available Unique Dataset and Samples from Pioneering HIV/AIDS Study in Africa to Researchers
[See Milestones above for detail]

 

 

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/
No new digest content identified.

 

IFRC [to 18 Jan 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Africa, Democratic Republic of the Congo
DR Congo: Red Cross volunteers attacked during Ebola burial
15 January 2020
[See Ebola above for detail]

 

IVAC [to 18 Jan 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
No new digest content identified.

 

IVI [to 18 Jan 2020]
http://www.ivi.int/
Selected IVI News & Announcements
IVI and Sweden renew partnership to accelerate vaccines for global public health
January 13, 2020 – SEOUL, South Korea – The International Vaccine Institute (IVI), a Seoul, Korea-based international organization, announced today that the Swedish International Cooperation Agency (Sida) will continue to support IVI’s mission to accelerate vaccine research and development for global health with a total contribution of SEK 50 million (approximately 5.24 million USD) over the next five years as part of a longstanding partnership between the Swedish government and IVI…
Sweden was one of the first countries to sign the IVI Establishment Agreement in 1997 and started funding IVI in 2002 through Sida. Since IVI’s first research collaboration with the University of Gothenburg and Swedish Biological Laboratories in 2000, Sweden has played an invaluable role in developing IVI’s landmark oral cholera vaccine (OCV), Shanchol, and later, Euvichol and Euvichol Plus, vaccines developed through technology transfer from IVI and prequalified by the WHO. To date, over 42 million doses of these low-cost OCVs have been deployed worldwide…

 

JEE Alliance [to 18 Jan 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 18 Jan 2020]
http://www.msf.org/
Latest [Selected Announcements]
No new digest content identified.

 

National Vaccine Program Office – U.S. HHS [to 18 Jan 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC 2020 Meetings
February 13-14, 2020 NVAC Meeting
June 9-10, 2020 NVAC Meeting
September 23-24, 2020 Meeting (Virtual)

 

NIH [to 18 Jan 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
Panel identifies need for improved implementation of preventive services and reduced health disparities
January 15, 2020 — Scientists urged to engage stakeholders inside and outside the health care system.

 

PATH [to 18 Jan 2020]
https://www.path.org/media-center/
Selected Announcements
No new digest content identified.

 

Sabin Vaccine Institute [to 18 Jan 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 18 Jan 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
No new digest content identified.

 

UNICEF [to 18 Jan 2020]
https://www.unicef.org/media/press-releases
Selected Statements, Press Releases, Reports
Statement
Libya: Tens of thousands of children at risk amidst violence and chaos of unrelenting conflict
Statement by UNICEF Executive Director Henrietta Fore
17/01/2020

Press release
First drone and data academy opens in Africa to improve service delivery for children
NEW YORK/ LILONGWE, 13 January 2020 – The first African Drone and Data Academy (ADDA) opened today in Lilongwe, Malawi, UNICEF announced.
The move is part of efforts to promote the use of drones in programmes and services that will impact the lives of children and young people.
“Humanitarian and development programme delivery in Africa and beyond can benefit significantly from the application of drone technology,” said UNICEF Executive Director Henrietta Fore. “The African Drone and Data Academy will be instrumental in equipping young people with the skills they need to use the technology to benefit children and their communities.”
Building on the work of Africa’s first humanitarian corridor launched in Malawi in 2017, the academy will develop expertise in the use of drones for humanitarian, development and commercial purposes across the continent through a 12-week course. It plans to train approximately 150 students to build and pilot drones by 2021. Funding from UNICEF’s partners will provide free tuition to the first cohort of 26 students from across Africa…

Media Advisory
Countries gather for the Global Forum on Childhood Pneumonia
World’s first conference on childhood pneumonia to take place in Barcelona from Jan 29-31
13/01/2020

 

Vaccination Acceptance Research Network (VARN) [to 18 Jan 2020]
https://vaccineacceptance.org/news.html#header1-2r
No new digest content identified.

 

Vaccine Confidence Project [to 18 Jan 2020]
http://www.vaccineconfidence.org/
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 18 Jan 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 18 Jan 2020]
https://wellcome.ac.uk/news
Opinion | 15 January 2020
It’s now beyond doubt: we need to reimagine the way research works
by Beth Thompson
The findings of our survey of more than 4,000 researchers expose the stark pressures that many face. But together, we can learn from one another’s good practice and come up with new ways to improve research culture.

 

The Wistar Institute [to 18 Jan 2020]
https://www.wistar.org/news/press-releases
No new digest content identified.

 

World Organisation for Animal Health (OIE) [to 18 Jan 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
No new digest content identified.

 

 

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ARM [Alliance for Regenerative Medicine] [to 18 Jan 2020]
https://alliancerm.org/press-releases/
No new digest content identified.

 

BIO [to 18 Jan 2020]
https://www.bio.org/press-releases
Press Releases
China Phase I Agreement Represents Important Step Towards Addressing Biotech Issues
Washington, D.C. (January 15, 2020) – BIO President and CEO Jim Greenwood released the following statement today regarding the signing of Phase One of the trade agreement with China: “…“We are currently reviewing the details, but we are pleased to see important commitments for agricultural biotechnology, biopharmaceuticals, and GM microorganisms, in addition to commitments related to forced technology transfer and intellectual property. We look forward to working closely with the Administration to monitor the implementation and enforcement of these provisions…”

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 18 Jan 2020]
http://www.dcvmn.org/
News
No new digest content identified.

 

IFPMA [to 18 Jan 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

 

PhRMA [to 18 Jan 2020]
http://www.phrma.org/
Selected Press Releases, Statements
Press Release
ICYMI: 2019 brings innovative medicines to patients
Andrew Powaleny   January 17, 2020
New reports from the U.S. Food and Drug Administration (FDA) show a total of 56 novel new medicines were approved in 2019. Among these, 48 were approved by the Center for Drug Evaluation and Research (CDER) and 8 were approved by the Center for Biologics Evaluation and Research (CBER). While medicine approval numbers vary each year, 2019 saw exciting advancements in drug development. These strong approval figures demonstrate biopharmaceutical companies’ unwavering commitment to developing innovative treatments for patients, offering hope for improved health outcomes…

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

Do patients and research subjects have a right to receive their genomic raw data? An ethical and legal analysis

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 18 Jan 2020)

 

Do patients and research subjects have a right to receive their genomic raw data? An ethical and legal analysis
As Next Generation Sequencing technologies are increasingly implemented in biomedical research and (translational) care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice.
Authors: Christoph Schickhardt, Henrike Fleischer and Eva C. Winkler
Citation: BMC Medical Ethics 2020 21:7
Content type: Research article
Published on: 16 January 2020

Vaccinating children against influenza: overall cost-effective with potential for undesirable outcomes

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 18 Jan 2020)

 

Vaccinating children against influenza: overall cost-effective with potential for undesirable outcomes
The present study aims to assess the cost-effectiveness of an influenza vaccination program for children in the Netherlands. This requires an evaluation of the long-term impact of such a program on the burden …
Authors: Pieter T. de Boer, Jantien A. Backer, Albert Jan van Hoek and Jacco Wallinga
Citation: BMC Medicine 2020 18:11
Content type: Research article
Published on: 14 January 2020

Using mobile phones to improve community health workers performance in low-and-middle-income countries

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 18 Jan 2020)

 

Using mobile phones to improve community health workers performance in low-and-middle-income countries
In low-and-middle-income countries community health workers are the core component of the PHC system as they act as a liaison between the communities and the healthcare facilities. Evidence suggests that the s…
Authors: Anam Feroz, Rawshan Jabeen and Sarah Saleem
Citation: BMC Public Health 2020 20:49
Content type: Debate
Published on: 13 January 2020

Factors affecting HBV vaccination in a Medical training College in Kenya: A mixed methods Study

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 18 Jan 2020)

 

Factors affecting HBV vaccination in a Medical training College in Kenya: A mixed methods Study
Hepatitis B Virus (HBV) is highly endemic in Sub-Saharan Africa with 70 to 90% of the population becoming infected before the age of 40 years. Healthcare workers (HCWs) including healthcare students (HCSs) are…
Authors: Anne Njeri Maina and Leah Chebet Bii
Citation: BMC Public Health 2020 20:48
Content type: Research article
Published on: 13 January 2020

Rethinking the incentive system in science: animal study registries: Preregistering experiments using animals could greatly improve transparency and reliability of biomedical studies and improve animal welfare

EMBO Reports
Volume 21 Issue 1 7 January 2020
https://www.embopress.org/toc/14693178/current

 

Science & Society 23 December 2019 Open Access
Rethinking the incentive system in science: animal study registries: Preregistering experiments using animals could greatly improve transparency and reliability of biomedical studies and improve animal welfare
Céline Heinl, Justyna Chmielewska, Anastasia Olevska, Barbara Grune, Gilbert Schönfelder, Bettina Bert
The Animal Study Registry offers scientists a range of benefits by preregistering their studies. Wider adoption could address the reproducibility problem in biomedical research and enhance animal welfare.

Spatial and temporal distribution of infectious disease epidemics, disasters and other potential public health emergencies in the World Health Organisation Africa region, 2016–2018

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 18 Jan 2020]

Spatial and temporal distribution of infectious disease epidemics, disasters and other potential public health emergencies in the World Health Organisation Africa region, 2016–2018
Emerging and re-emerging diseases with pandemic potential continue to challenge fragile health systems in Africa, creating enormous human and economic toll. To provide evidence for the investment case for publ…

Authors: Ambrose Otau TALISUNA, Emelda Aluoch OKIRO, Ali Ahmed YAHAYA, Mary STEPHEN, Boukare BONKOUNGOU, Emmanuel Onuche MUSA, Etienne Magloire MINKOULOU, Joseph OKEIBUNOR, Benido IMPOUMA, Haruna Mamoudou DJINGAREY, N’da Konan Michel YAO, Sakuya OKA, Zabulon YOTI and Ibrahima Socé FALL

Content type: Research

15 January 2020

 

Methods to promote equity in health resource allocation in low- and middle-income countries: an overview

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 18 Jan 2020]

Methods to promote equity in health resource allocation in low- and middle-income countries: an overview
Unfair differences in healthcare access, utilisation, quality or health outcomes exist between and within countries around the world. Improving health equity is a stated objective for many governments and inte…
Authors: James Love-Koh, Susan Griffin, Edward Kataika, Paul Revill, Sibusiso Sibandze and Simon Walker
Content type: Review
13 January 2020

FDA Approval and Regulation of Pharmaceuticals, 1983-2018

JAMA
January 14, 2020, Vol 323, No. 2, Pages 105-196
http://jama.jamanetwork.com/issue.aspx

 

Special Communication
FDA Approval and Regulation of Pharmaceuticals, 1983-2018
Jonathan J. Darrow, SJD, JD, MBA; Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH
JAMA. 2020;323(2):164-176. doi:10.1001/jama.2019.20288
Key Points
Question  How has the regulation of prescription drugs evolved from the 1980s to 2018, and what trends have occurred in drug approvals?
Findings  Approvals of new generic drugs have increased over time, leading to greater competition. Technological advances have been reflected in increased approvals of biologics over time. The number of expedited development and approval programs has expanded greatly since 1983, reducing the amount of evidence available at the time of approval and increasing uncertainty about the existence or amount of clinical benefit. These regulatory innovations have not clearly led to an increase in new drug approvals or to reduced total development times.
Meaning  While retaining policies that encourage efficient review, Congress and other government officials should also consider the implications of less rigorous clinical outcome requirements and whether the current complex array of regulatory programs should be simplified.

Abstract
Importance  US law requires testing of new drugs before approval to ensure that they provide a well-defined benefit that is commensurate with their risks. A major challenge for the US Food and Drug Administration (FDA) is to achieve an appropriate balance between rigorous testing and the need for timely approval of drugs that have benefits that outweigh their risks.
Objective  To describe the evolution of laws and standards affecting drug testing, the use of new approval programs and standards, expansions of the role and authority of the FDA, and changes in the number of drugs approved from the 1980s to 2018.
Evidence  Sources of evidence included principal federal laws and FDA regulations (1962-2018) and FDA databases of approved new drugs (1984-2018), generic drugs (1970-2018), biologics (1984-2018), and vaccines (1998-2018); special development and approval programs (Orphan drug [1984-2018], Fast-Track [1988-2018], Priority Review and its predecessors [1984-2018], Accelerated Approval [1992-2018], and Breakthrough Therapy [2012-2018]); expanded access (2010-2017) and Risk Evaluation and Mitigation Strategies (2008-2018); and user fees paid to the FDA by industry (1993-2018).
Findings  From 1983 to 2018, legislation and regulatory initiatives have substantially changed drug approval at the FDA. The mean annual number of new drug approvals, including biologics, was 34 from 1990-1999, 25 from 2000-2009, and 41 from 2010-2018. New biologic product approvals increased from a median of 2.5 from 1990-1999, to 5 from 2000-2013, to 12 from 2014-2018. The median annual number of generic drugs approved was 136 from 1970 to the enactment of the Hatch-Waxman Act in 1984; 284 from 1985 to the enactment of the Generic Drug User Fee Act in 2012; and 588 from 2013-2018. Prescription drug user fee funding expanded from new drugs and biologics in 1992 to generic and biosimilar drugs in 2012. The amount of Prescription Drug User Fee Act fees collected from industry increased from an annual mean of $66 million in 1993-1997 to $820 million in 2013-2017, and in 2018, user fees accounted for approximately 80% of the salaries of review personnel responsible for the approval of new drugs. The proportion of drugs approved with an Orphan Drug Act designation increased from 18% (55/304) in 1984-1995, to 22% (82/379) in 1996-2007, to 41% (154/380) in 2008-2018. Use of Accelerated Approval, Fast-Track, and Priority Review for new drugs has increased over time, with 81% (48/59) of new drugs benefiting from at least 1 such expedited program in 2018. The proportion of new approvals supported by at least 2 pivotal trials decreased from 80.6% in 1995-1997 to 52.8% in 2015-2017, based on 124 and 106 approvals, respectively, while the median number of patients studied did not change significantly (774 vs 816). FDA drug review times declined from more than 3 years in 1983 to less than 1 year in 2017, but total time from the authorization of clinical testing to approval has remained at approximately 8 years over that period.
Conclusions and Relevance  Over the last 4 decades, the approval and regulation processes for pharmaceutical agents have evolved and increased in complexity as special programs have been added and as the use of surrogate measures has been encouraged. The FDA funding needed to implement and manage these programs has been addressed by expanding industry-paid user fees. The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times.

Treatment Decisions for a Future SelfEthical Obligations to Guide Truly Informed Choices

JAMA
January 14, 2020, Vol 323, No. 2, Pages 105-196
http://jama.jamanetwork.com/issue.aspx

 

Viewpoint
Treatment Decisions for a Future SelfEthical Obligations to Guide Truly Informed Choices
Claire J. Creutzfeldt, MD; Robert G. Holloway, MD, MPH
JAMA. 2020;323(2):115-116. doi:10.1001/jama.2019.19652
This Viewpoint discusses the reality that most decisions about treatment for incapacitated patients involve surrogate assessments of patients’ past values at their baseline health, and it proposes that more ethical and informed decision-making would help surrogates consider the degree to which their loved one might be able to adapt to and value a future health state at what is a higher level of disability.

Monitoring the health-related Sustainable Development Goals: lessons learned and recommendations for improved measurement

The Lancet
Jan 18, 2020 Volume 395Number 10219p165-246, e6-e13
https://www.thelancet.com/journals/lancet/issue/current

 

Viewpoint
Monitoring the health-related Sustainable Development Goals: lessons learned and recommendations for improved measurement
Samira Asma, Rafael Lozano, Somnath Chatterji, Soumya Swaminathan, Maria de Fátima Marinho, Naoko Yamamoto, Elena Varavikova, Awoke Misganaw, Michael Ryan, Lalit Dandona,
Ren Minghui, Christopher J L Murray
The UN General Assembly launched the Sustainable Development Goals (SDGs) in September, 2015.1 The original global SDG framework included 17 goals, 169 targets, and 232 unique indicators.2 Of these, 12 goals, 33 targets, and 57 indicators have been identified as health-related SDGs (HRSDGs),3,4,5,6 that is, pertaining to health outcomes, health services, and well-established environmental, occupational, behavioural, and metabolic risks. The scope of health in the SDGs is much broader than in the Millennium Development Goals, spanning from maternal and child health and infectious diseases to non-communicable diseases, injuries, risk factors, and health-system functions. Regular monitoring of the HRSDGs is important for fostering a shared notion of accountability for results, identifying important gaps in resources and rates of progress, and taking into account emerging challenges that can influence the trajectory of progress. Regular monitoring and accountability will be essential to sustain policy focus and funding for the broad and complex HRSDG agenda.

The arms race between bacteria and their phage foes

Nature
Volume 577 Issue 7790, 16 January 2020
http://www.nature.com/nature/current_issue.html

 

Review Article | 15 January 2020
The arms race between bacteria and their phage foes
Understanding the dynamics between bacteria and bacteriophages could enable the development of phage-based therapies and biotechnological tools and provide insights into the ecology and evolution of these microorganisms.
Hannah G. Hampton, Bridget N. J. Watson & Peter C. Fineran

Returning incidental findings in African genomics research

Nature Genetics
Volume 52 Issue 1, January 2020
https://www.nature.com/ng/volumes/52/issues/1

 

Comment | 25 November 2019
Returning incidental findings in African genomics research
Ancestral and geographical issues underlie the need to develop Africa-specific guidelines for the return of genomics research results in Africa. In this Commentary, we outline the challenges that will inform policies and practices in the future.
Ambroise Wonkam & Jantina de Vries

A call for global action for rare diseases in Africa

Nature Genetics
Volume 52 Issue 1, January 2020
https://www.nature.com/ng/volumes/52/issues/1

 

Comment | 23 December 2019
A call for global action for rare diseases in Africa
The 11th International Conference on Rare Diseases and Orphan Drugs (ICORD), South Africa, included the Africa-Rare initiative launch and facilitated multi-stakeholder engagement in the challenges facing, and opportunities for, Africans living with rare diseases. The following ICORD Global Call to Action, developed in collaboration with the International Rare Diseases Research Consortium, synthesizes the outcomes of the deliberations and emphasizes the international collaborative efforts required to address the global effects of rare diseases on public health.
Gareth S. Baynam, Stephen Groft[…] & Manuel Posada

Axes of a revolution: challenges and promises of big data in healthcare

Nature Medicine
Volume 26 Issue 1, January 2020
https://www.nature.com/nm/volumes/26/issues/1

 

Review Article | 13 January 2020
Axes of a revolution: challenges and promises of big data in healthcare
Health data are being generated and collected at an unprecedented scale, but whether big data will truly revolutionize healthcare is still a matter of much debate.
Smadar Shilo, Hagai Rossman & Eran Segal

Characterization and analytical validation of a new antigenic rapid diagnostic test for Ebola virus disease detection

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 18 Jan 2020)

 

Characterization and analytical validation of a new antigenic rapid diagnostic test for Ebola virus disease detection
Céline Couturier, Atsuhiko Wada, Karen Louis, Maxime Mistretta, Benoit Beitz, Moriba Povogui, Maryline Ripaux, Charlotte Mignon, Bettina Werle, Adrien Lugari, Delphine Pannetier, Sabine Godard, Anne Bocquin, Stéphane Mely, Ismaël Béavogui, Jean Hébélamou, David Leuenberger, Philippe Leissner, Takeshi Yamamoto, Patrick Lécine, Christophe Védrine, Julie Chaix
Research Article | published 17 Jan 2020 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0007965

Family Health Days program contributions in vaccination of unreached and under-immunized children during routine vaccinations in Uganda

PLoS One
http://www.plosone.org/
(Accessed 18 Jan 2020)

 

Family Health Days program contributions in vaccination of unreached and under-immunized children during routine vaccinations in Uganda
Ezekiel Mupere, Harriet M. Babikako, Violet Okaba-Kayom, Robert B. Mutyaba, Milton Nasiero Mwisaka, Emmanuel Tenywa, Albert Lule, Jane Ruth Aceng, Flavia Mpanga-Kaggwa, David Matseketse, Eresso Aga
Research Article | published 17 Jan 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0218239

Constructing and influencing perceived authenticity in science communication: Experimenting with narrative

PLoS One
http://www.plosone.org/
(Accessed 18 Jan 2020)

 

Constructing and influencing perceived authenticity in science communication: Experimenting with narrative
Lise Saffran, Sisi Hu, Amanda Hinnant, Laura D. Scherer, Susan C. Nagel
Research Article | published 15 Jan 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0226711

The ecology of human–nature interactions

Proceedings of the Royal Society B
15 January 2020 Volume 287Issue 1918
https://royalsocietypublishing.org/toc/rspb/current

 

Review articles
The ecology of human–nature interactions
Masashi Soga and Kevin J. Gaston
Published:15 January 2020Article ID:20191882
The direct interactions between people and nature are critically important in many ways, with growing attention particularly on their impacts on human health and wellbeing (both positive and negative), on people’s attitudes and behaviour towards nature, …

Transparency on trial

Science
17 January 2020 Vol 367, Issue 6475
http://www.sciencemag.org/current.dtl

 

Feature
Transparency on trial
By Charles Piller
Science17 Jan 2020 : 240-243 Full Access
Many clinical trial results aren’t posted publicly, as U.S. law requires—and a promised crackdown has fizzled.
Summary
Companies, universities, and other institutions that conduct clinical trials are required to record the results of most of them in a federal database, so that doctors and patients can see whether new treatments are safe and effective. But a Science investigation has found that many persist in not reporting those results, and the U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) are doing little to nothing to enforce the reporting requirement—despite recent promises to the contrary. While many pharma companies have improved their reporting of trial results over the past few years, a large number of universities and academic medical centers continue to have bad records. Ironically, NIH itself is part of the problem—its top institutes for clinical trials have a poor record of reporting results of those trials for which they are responsible. Science checked all 4768 trials whose results have come due under legal requirements finalized by NIH and FDA 3 years ago. Overall, sponsors violated the reporting law more than 55% of the time. Yet FDA has never fined a trial sponsor for noncompliance and NIH has never publicly named or withdrawn a grant from violators, although such actions were vowed in 2016 when ClinicalTrials.gov’s requirements were clarified.

Words matter: Vaccine hesitancy, vaccine demand, vaccine confidence, herd immunity and mandatory vaccination

Vaccine
Volume 38, Issue 4 Pages 709-950 (22 January 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/4

 

Discussion No access
Words matter: Vaccine hesitancy, vaccine demand, vaccine confidence, herd immunity and mandatory vaccination
Matthew Z. Dudley, Lois Privor-Dumm, Ève Dubé, Noni E. MacDonald
Pages 709-711

Genotype distribution of Group A rotavirus in children before and after massive vaccination in Latin America and the Caribbean: Systematic review

Vaccine
Volume 38, Issue 4 Pages 709-950 (22 January 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/4

 

Research article Abstract only
Genotype distribution of Group A rotavirus in children before and after massive vaccination in Latin America and the Caribbean: Systematic review
Juan Ignacio Degiuseppe, Juan Andrés Stupka
Pages 733-740

Perception of mandatory infant vaccines and trust in vaccination among first-year healthcare students: An opportunity window for the training of future healthcare workers

Vaccine
Volume 38, Issue 4 Pages 709-950 (22 January 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/4

 

Research article Abstract only
Perception of mandatory infant vaccines and trust in vaccination among first-year healthcare students: An opportunity window for the training of future healthcare workers
Lola Daudel, Jessica Mary, Olivier Epaulard
Pages 794-799

Strengthening vaccination frameworks: Findings of a study on the legal foundations of National Immunization Technical Advisory Groups (NITAGs)

Vaccine
Volume 38, Issue 4 Pages 709-950 (22 January 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/4

 

Research article Abstract only
Strengthening vaccination frameworks: Findings of a study on the legal foundations of National Immunization Technical Advisory Groups (NITAGs)
Shawn H.E. Harmon, David Faour, Noni E. MacDonald, Janice Graham, … Stephanie Shendale
Pages 840-846

Human Papillomavirus (HPV) Vaccine Uptake and the Willingness to Receive the HPV Vaccination among Female College Students in China: A Multicenter Study

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 18 Jan 2020)

 

Open Access Article
Human Papillomavirus (HPV) Vaccine Uptake and the Willingness to Receive the HPV Vaccination among Female College Students in China: A Multicenter Study
by Dingyun You , Liyuan Han , Lian Li , Jingcen Hu , Gregory D. Zimet , Haridah Alias , Mahmoud Danaee , Le Cai , Fangfang Zeng and Li Ping Wong
Vaccines 2020, 8(1), 31; https://doi.org/10.3390/vaccines8010031 – 16 Jan 2020
Abstract
Background: This study aimed to determine human papillomavirus (HPV) vaccine uptake and willingness to receive HPV vaccination among female college students, in China, and its associated factors. Methods: An online cross-sectional survey of female college students across the eastern, central, and western regions of China was undertaken between April and September 2019. Partial least squares structural equation modeling (PLS-SEM) was used to examine factors associated with the HPV vaccine uptake and willingness to receive the HPV vaccine. Results: Among the total 4220 students who participated in this study, 11.0% reported having been vaccinated against HPV. There are direct effects of indicators of higher socioeconomic status, older age (β = 0.084 and p = 0.006), and geographical region (residing in Eastern China, β = 0.033, and p = 0.024) on HPV vaccine uptake. Higher knowledge (β = 0.062 and p < 0.000) and perceived susceptibility (β = 0.043 and p = 0.002) were also predictors of HPV vaccine uptake. Of those who had not received the HPV vaccine, 53.5% expressed a willingness to do so. Likewise, social economic status indicators were associated with the willingness to receive the HPV vaccine. Total knowledge score (β = 0.138 and p < 0.001), both perceived susceptibility (β = 0.092 and p < 0.001) and perceived benefit (β = 0.088 and p < 0.001), and sexual experience (β = 0.041 and p = 0.007) had a positive and significant direct effect on the willingness to receive the HPV vaccine, while perceived barriers (β = −0.071 and p < 0.001) had a negative effect on the willingness to receive the HPV vaccine. Conclusions: Geographical region and socioeconomic disparities in the HPV vaccination uptake rate and willingness to receive the HPV vaccine provide valuable information for public health planning that aims to improve vaccination rates in underserved areas in China. The influence of knowledge and perceptions of HPV vaccination suggests the importance of communication for HPV immunization.

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

International Journal for Equity in Health
19, Article number: 10 (2020
The impact of vaccination on gender equity: conceptual framework and human papillomavirus (HPV) vaccine case study
A Portnoy, S Clark, S Ozawa, M Jit –
Although the beneficial effects of vaccines on equity by socioeconomic status and geography are increasingly well-documented, little has been done to extend these analyses to examine the linkage between vaccination and gender equity. In this paper, evidence from the published literature is used to develop a conceptual framework demonstrating the potential impact of vaccination on measures of gender equity. This framework is then applied to human papillomavirus (HPV) vaccination in three countries with different economic and disease burden profiles to establish a proof of concept in a variety of contexts.

 

International Journal of Nursing Science Practice and Research
Vol 5, No 2 (2019)
Exploring Vaccine Hesitancy
CE Fisher
Abstract
According to the World Health Organization, the coverage of vaccine-preventable diseases rests at 86% with nearly 20 million children worldwide who have not received basic vaccines. Vaccine-hesitant individuals are a heterogeneous group who hold varying degrees of indecision about specific vaccines or vaccination in general. Vaccine hesitancy is a behavior influenced by several factors including issues of confidence, complacency, and convenience. In countries where access is not the main issue for lack of vaccination, there are many cultural influences that affect the decision for parents to seek vaccination for their children or themselves. Media and social media can create a negative or positive vaccine sentiment and can provide a platform for lobbies and key opinion leaders to influence others. Community leaders and influencers, including religious leaders in some settings, celebrities in others, can all have a significant influence on vaccine acceptance or hesitancy. Vaccine mandates can provoke vaccine hesitancy not necessarily because of safety or other concerns, but due to resistance to the notion of forced vaccination. Lastly, the pharmaceutical industry may be distrusted and influence vaccine hesitancy when perceived as driven only by financial motives and not by public health interest. This can extend to distrust in government when perceived that it also is being pushed by industry and is not transparent. When working with patients faced with the decision of whether vaccination will be undertaken, it is imperative to understand the cultural, ethical, and legal implications that may affect their decision. Working from a place of understanding and acceptance of various views and beliefs about vaccination, nurses can be better advocates for the wishes of their patients.

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 18 Jan 2020
[No new, unique, relevant content]

 

BBC
http://www.bbc.co.uk/
Accessed 18 Jan 2020
[No new, unique, relevant content]

 

The Economist
http://www.economist.com/
Accessed 18 Jan 2020
[No new, unique, relevant content]

 

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

 

Forbes
http://www.forbes.com/
Accessed 18 Jan 2020
Editors’ Pick Jan 12, 2020
Fighting Polio: What Happened In 2019 And What Is Next
Bruce Y. Lee Senior Contributor

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 18 Jan 2020
[No new, unique, relevant content]

 

Foreign Policy
http://foreignpolicy.com/
Accessed 18 Jan 2020
China Deserves Some Credit for Its Handling of the Wuhan Pneumonia
The country’s response to this outbreak has been far better than to SARS, although even more information-sharing is important.
Argument |
Daniel Lucey, Annie Sparrow

 

The Guardian
http://www.guardiannews.com/
Accessed 18 Jan 2020
[No new, unique, relevant content]

 

New Yorker
http://www.newyorker.com/
Accessed 18 Jan 2020
[No new, unique, relevant content]

 

New York Times
http://www.nytimes.com/
Accessed 18 Jan 2020
New York
How Anti-Vaccine Activists Doomed a Bill in New Jersey
Angry parents, an ultra-Orthodox Jewish group and anti-vaccine celebrities rallied to outmatch one of the state’s most powerful elected leaders.
By Tracey Tully, Sharon Otterman and Jan Hoffman
Jan. 16

 

Washington Post
https://www.washingtonpost.com/
Accessed 18 Jan 2020
Vaccine foes raise more money than supporters ahead of vote
Jan 16, 2020
AUGUSTA, Maine — A group that wants to overturn Maine’s law eliminating religious and philosophical exemptions for vaccinations raised more than three times more money than supporters of the law, according to campaign finance reports.
Mainers for Health and Parental Rights reported $203,988 in contributions and loans to press for rejection of the law in a statewide referendum on the March 3 ballot. Top donors included a University of Maine professor who gave $13,500, according to the Maine Ethics Commission Campaign Finance website.
A group that wants to keep the law, Maine Families for Vaccines PAC, reported raising $58,098. The top donors were the Maine Hospital Association, which gave $25,000, and the Maine Academy of Family Physicians, which gave nearly $5,000…

Think Tanks et al

Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 18 Jan 2020
[No new relevant content]

 

Center for Global Development
http://www.cgdev.org/page/press-center
Accessed 18 Jan 2020
[No new relevant content]

 

CSIS
https://www.csis.org/
Accessed 18 Jan 2020
[No new relevant content]

 

Council on Foreign Relations
http://www.cfr.org/
Accessed 18 Jan 2020
January 15, 2020
Health
Why Experts Are Worried About a New Virus in China
The virus appears to be less dangerous than SARS, but there are still concerns of a wider outbreak in Asia.
In Brief by Yanzhong Huang

 

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 18 Jan 2020
[No new relevant content]

Vaccines and Global Health: The Week in Review :: 11 January 2020

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

pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_11 Jan 2020

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

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

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

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

Deaths from Democratic Republic of the Congo measles outbreak top 6000

Milestones :: Perspectives :: Research

 

Deaths from Democratic Republic of the Congo measles outbreak top 6000
Kinshasa, 7 January 2020 – With the death toll from the world’s worst measles epidemic in the Democratic Republic of the Congo (DRC) surpassing 6000, the World Health Organization (WHO) is calling for more funding to stop the outbreak.

Under the leadership of the DRC Ministry of Health, WHO, Gavi, the Vaccine Alliance, and other partner aid agencies vaccinated more than 18 million children under five across the country in 2019. However, in some areas, routine vaccination coverage remains low and 25% of the reported measles cases are in children over the age of five.

“We are doing our utmost to bring this epidemic under control. Yet to be truly successful we must ensure that no child faces the unnecessary risk of death from a disease that is easily preventable by a vaccine. We urge our donor partners to urgently step up their assistance,” said Dr Matshidiso Moeti, WHO Regional Director for Africa.

Since the start of 2019, around 310,000 suspected measles cases have been reported. The epidemic has been aggravated by low vaccination coverage among vulnerable communities, malnutrition, weak public health systems, outbreaks of other epidemic-prone diseases, difficult access by vulnerable populations to health care and insecurity that has hampered response in some areas.

Lack of funding remains a huge impediment to successfully curbing the outbreak. So far, US$ 27.6 million have been mobilized. However, a further US$ 40 million are required for a six-month plan to extend the vaccination to children between six and 14 years and to reinforce elements of the outbreak response beyond vaccination, including improving treatment, health education, community engagement, health system strengthening, epidemiological surveillance and response coordination…

WHO Statement Regarding Cluster of Pneumonia Cases in Wuhan, China

Milestones :: Perspectives :: Research

 

WHO Statement Regarding Cluster of Pneumonia Cases in Wuhan, China
9 January 2020
Statement, China
Chinese authorities have made a preliminary determination of a novel (or new) coronavirus, identified in a hospitalized person with pneumonia in Wuhan. Chinese investigators conducted gene sequencing of the virus, using an isolate from one positive patient sample. Preliminary identification of a novel virus in a short period of time is a notable achievement and demonstrates China’s increased capacity to manage new outbreaks.

Initial information about the cases of pneumonia in Wuhan provided by Chinese authorities last week – including the occupation, location and symptom profile of the people affected – pointed to a coronavirus (CoV) as a possible pathogen causing this cluster. Chinese authorities subsequently reported that laboratory tests ruled out SARS-CoV, MERS-CoV, influenza, avian influenza, adenovirus and other common respiratory pathogens.

Coronaviruses are a large family of viruses with some causing less-severe disease, such as the common cold, and others more severe disease such as MERS and SARS. Some transmit easily from person to person, while others do not. According to Chinese authorities, the virus in question can cause severe illness in some patients and does not transmit readily between people.

Globally, novel coronaviruses emerge periodically in different areas, including SARS in 2002 and MERS in 2012. Several known coronaviruses are circulating in animals that have not yet infected humans. As surveillance improves more coronaviruses are likely to be identified.

China has strong public health capacities and resources to respond and manage respiratory disease outbreaks. In addition to treating the patients in care and isolating new cases as they may be identified, public health officials remain focused on continued contact tracing, conducting environmental assessments at the seafood market, and investigations to identify the pathogen causing the outbreak.

In the coming weeks, more comprehensive information is required to understand the current status and epidemiology of the outbreak, and the clinical picture. Further investigations are also required to determine the source, modes of transmission, extent of infection and countermeasures implemented. WHO continues to monitor the situation closely and, together with its partners, is ready to provide technical support to China to investigate and respond to this outbreak.

The preliminary determination of a novel virus will assist authorities in other countries to conduct disease detection and response. Over the past week, people with symptoms of pneumonia and reported travel history to Wuhan have been identified at international airports.
WHO does not recommend any specific measures for travellers. WHO advises against the application of any travel or trade restrictions on China based on the information currently available.

Effect of donor funding for immunization from Gavi and other development assistance channels on vaccine coverage: Evidence from 120 low and middle income recipient countries

Featured Journal Content

 

Vaccine
Volume 38, Issue 3 Pages 411-708 (16 January 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/2
Research article Open access
Effect of donor funding for immunization from Gavi and other development assistance channels on vaccine coverage: Evidence from 120 low and middle income recipient countries
Gloria Ikilezi, Orvalho J. Augusto, Joseph L. Dieleman, Kenneth Sherr, Stephen S. Lim
Pages 588-596
Abstract
Donor assistance for immunization has remained resilient with increased resource mobilization efforts in recent years to achieve current global coverage targets. As a result, more countries continue to introduce new vaccines while optimizing coverage for traditional vaccines. Gavi the Vaccine Alliance has been at the forefront of immunization support specifically among low and middle income countries, alongside other channels of development assistance which continue to play a vital role in immunization.

Using available recipient country level data from 1996 to 2016, we estimate the impact of Gavi support for vaccines and health systems strengthening on vaccine coverage for 3 dose DPT, 3 dose pneumococcal conjugate vaccine, 3 dose pentavalent, 2 dose measles and 2 dose rotavirus vaccines. We investigate the same effects of total aid for immunization from other channels of development assistance. Standard time series cross sectional analysis methods are applied to investigate the effects of vaccine support controlling for country income, governance and population, with robustness tests implemented using different model specifications. Double counting was eliminated and results are presented in real 2017 US dollars.

We found significant positive effects of aid particularly among the newer vaccines. Using 2016 country specific disbursements and coverage levels as baseline, we estimated that among recipient countries below the universal target, additional DAH per capita required to reach 90%, ranged from 0.01USD to 4.33USD for PCV, 0.03USD to 9.06USD for pentavalent vaccine and 0.01USD to 2.57USD for rotavirus vaccine. The estimated number of children vaccinated through 2016, attributable to Gavi support totaled 46.6million, 75.2million and 12.3million for PCV, pentavalent and rotavirus vaccines respectively.

Our analysis suggests substantial success both from a historical and prospective perspective in the implementation of global immunization initiatives thus far. As more vaccines are rolled out and countries transition from donor aid, strategies for fiscal sustainability and efficiency need to be strengthened in order to achieve universal immunization coverage

Strengthening national laboratories’ oversight capacity to support measles and rubella elimination

Featured Journal Content

 

Strengthening national laboratories’ oversight capacity to support measles and rubella elimination
08-01-2020
WHO
Detection and control of communicable diseases would not be possible without accurate laboratory data on when and where a particular disease is circulating. WHO/Europe therefore works with all Member States to steadily improve the quality and reliability of the laboratory data used to determine the Region’s progress towards measles and rubella elimination. The latest step in this process is to support accredited laboratories at national level in developing country-specific oversight mechanisms to ensure quality data is received from all levels of their countries’ disease surveillance systems.

 

No disease elimination verification without quality data
Measles and rubella are targeted for elimination in the European Region. Each year the independent European Regional Verification Commission for Measles and Rubella Elimination (RVC) meets to review country reports and verify whether each country remains endemic for these diseases or has successfully prevented the viruses or stopped them from spreading within their borders. To make these assessments, the RVC requires reliable evidence, including the volume and outcome of laboratory testing of suspected cases, in addition to the number and proportion of children vaccinated each year. As a country progresses toward measles and/or rubella elimination, increasingly complex laboratory evidence is required to verify the country’s status.

 

Critical steps towards in-country oversight
WHO/Europe coordinates the European Measles and Rubella Laboratory Network (MR LabNet). Each of the national laboratories in this network undergoes regular external quality assessment through an annual accreditation programme. They all also benefit from periodic regional meetings, technical updates and training.

In many Member States, however, measles and rubella testing is often performed in non-WHO-accredited laboratories and several Member States still fail to provide information about the proficiency of these laboratories. Strengthening the role of national laboratories in overseeing the performance of subnational laboratories in these countries has become a critical need in monitoring the Region’s measles and rubella elimination efforts.

Supported by their health authorities, some WHO-accredited national laboratories have undertaken different approaches to ensure quality, ranging from limited periodic quality control to establishing and coordinating national laboratory networks with a comprehensive accreditation system aligned with that of WHO.

To support Member States that have not yet initiated an oversight mechanism in line with WHO recommendations, WHO/Europe organized a technical consultation for the MR LabNet on 14–15 November 2019. The meeting brought together delegations from 8 countries; senior laboratory experts from the regional reference laboratory in Berlin, Germany, and the global specialized laboratory in London, United Kingdom; a representative of the Regional Verification Commission; and an observer from the European Centre for Disease Prevention and Control. Together they reviewed their national contexts and developed country-specific work plans for establishing national networks and/or oversight mechanisms, including preliminary monitoring and evaluation indicators. WHO/Europe will compile country best practices and lessons learned and share them in a publication to provide inspiration and guidance to other countries that have not yet established oversight mechanisms.

Establishing oversight mechanisms and/or national measles and rubella laboratory networks compliant with MR LabNet standards will not only optimize the participation of these networks in national and regional processes to verify disease elimination, but also contribute to strengthening the quality of vaccine-preventable disease surveillance…

Emergencies

Emergencies

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

Ebola Outbreak in DRC 74: 07 January 2020
Situation Update
Since the last Situation Report 73 issued on 24 December 2019, 28 new confirmed Ebola virus disease (EVD) cases were reported from five health zones in two affected provinces in the Democratic Republic of the Congo between 23 December 2019 to 5 January 2020. The new confirmed cases in the past 14 days are from Butembo, Katwa, Kalunguta, Mabalako and Mambasa. The source of exposure for the four new cases reported from Mambasa Health Zone, Ituri Province is currently under investigation. Mambasa Health Zone had previously not had a confirmed case for 66 days. Similarly, the source of exposure of the initial case reported in Kalunguta at the end of December is still under investigation…

…As of 5 January 2020, a total of 3390 EVD cases, including 3272 confirmed and 118 probable cases have been reported, of which 2233 cases died (overall case fatality ratio 66%). Of the total confirmed and probable cases, 56% (1903) were female, 28% (956) were children aged less than 18 years, and 5% (168) were healthcare workers.

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

POLIO
Public Health Emergency of International Concern (PHEIC)
http://polioeradication.org/polio-today/polio-now/this-week/

Summary of new viruses this week (AFP cases and ES positives):
:: Afghanistan — two WPV1 cases and two WPV1 positive environmental samples;
:: Pakistan — 11 WPV1 cases, 13 WPV1 positive environmental samples and two cVDPV2 positive environmental samples;
:: Malaysia — one cVDPV2 and one positive environmental samples;
:: Zambia — 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 11 Jan 2020]

Democratic Republic of the Congo
:: Ebola Outbreak in DRC 74: 07 January 2020
[See Ebola above for detail]

Mozambique floods – No new digest announcements identified
Nigeria – No new digest announcements identified
Somalia – No new digest announcements identified
South Sudan – No new digest announcements identified
Syrian Arab Republic – No new digest announcements identified
Yemen – No new digest announcements identified

::::::

WHO Grade 2 Emergencies [to 11 Jan 2020]
Measles in Europe
:: Strengthening national laboratories’ oversight capacity to support measles and rubella elimination 08-01-2020
[See Milestones above for detail]

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
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 11 Jan 2020]

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
:: Syrian Arab Republic: Recent Developments in Northwestern Syria Situation Report No. 5 – As of 8 January 2020

Yemen – No new digest announcements identified

::::::

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
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 11 Jan 2020]

WHO & Regional Offices [to 11 Jan 2020]
6 January 2020 News release
Ministry of Health Lauds Partners for Support during Ebola Preparedness Response in Uganda

 

::::::

Weekly Epidemiological Record, 10 January 2020, vol. 95, 01/02 (pp. 1–12)
Review of the 2019 influenza season in the southern hemisphere

 

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
No new digest content identified.

WHO Region of the Americas PAHO
No new digest content identified.

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

WHO European Region EURO
:: Time for integrated and people-centred services for HIV, TB and viral hepatitis 10-01-2020
;; Cluster of pneumonia cases in Wuhan, China 10-01-2020

WHO Eastern Mediterranean Region EMRO
No new digest content identified.

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CDC/ACIP [to 11 Jan 2020]

CDC/ACIP [to 11 Jan 2020]
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MMWR News Synopsis January 10, 2020
Population Movement Patterns Among the Democratic Republic of the Congo, Rwanda, and Uganda During an Outbreak of Ebola Virus Disease: Results from Community Engagement in Two Districts — Uganda, March 2019
Trade and business, need for health care, visits to family, refugee support, and insecurity in the Democratic Republic of the Congo (DRC) drive population movement patterns between Rwanda, Uganda, and the provinces in eastern DRC that are experiencing an Ebola outbreak. One of the ground crossing closures in Rwanda initiated in February 2019 caused significant shifts in some cross-border movement patterns leading to travel between Goma and Uganda that avoided Rwanda and passed through more insecure areas of DRC. The 10th Ebola virus disease (EVD) DRC was declared in an area with a high volume of cross-border movement. Officials in southwest Uganda identified 31 locations in their communities where people from eastern DRC visit and traced cross-border movement pathways to the EVD outbreak areas.

Case Definitions Used During the First 6 Months of the 10th Ebola Virus Disease Outbreak in the Democratic Republic of the Congo — Four Neighboring Countries, August 2018–February 2019
If a disease outbreak is occurring near international borders, harmonizing case definitions between neighboring countries can be vital to effective cross-border communication and collaboration. The Democratic Republic of Congo (DRC) is experiencing its 10th Ebola virus disease (EVD) outbreak in an area with a high volume of cross-border population movement. The World Health Organization (WHO) designated Rwanda, South Sudan, and Uganda priority countries for Ebola preparedness because of the high risk of cross-border spread. The CDC worked with ministries of health in DRC, Rwanda, South Sudan, and Uganda to collect each ministry-of-health-approved EVD case definition during the first six months of the outbreak to evaluate the similarities and differences across countries. Case definitions are used to identify people who might have a particular disease based on signs and symptoms of illness, exposure history, and laboratory test results. Harmonizing case definitions across neighboring countries can improve collaboration and help reduce the risk of cross-border disease spread.