New England Journal of Medicine
April 9, 2020 Vol. 382 No. 15
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Covid-19 — The Law and Limits of Quarantine
Wendy E. Parmet, J.D., and Michael S. Sinha, M.D., J.D., M.P.H.

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 11 Apr 2020)

Pre-exposure prophylaxis for preventing acquisition of HIV: A cross-sectional study of patients, prescribers, uptake, and spending in the United States, 2015–2016
Stephanie S. Chan, Andre R. Chappel, Karen E. Joynt Maddox, Karen W. Hoover, Ya-lin A. Huang, Weiming Zhu, Stacy M. Cohen, Pamela W. Klein, Nancy De Lew
Research Article | published 10 Apr 2020 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1003072

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 11 Apr 2020)

Will COVID-19 become the next neglected tropical disease?
Peter J. Hotez, Maria E. Bottazzi, Sunit K. Singh, Paul J. Brindley, Shaden Kamhawi
Editorial | published 10 Apr 2020 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0008271

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 11 Apr 2020)

Modelling for policy: The five principles of the Neglected Tropical Diseases Modelling Consortium
Matthew R. Behrend, María-Gloria Basáñez, Jonathan I. D. Hamley, Travis C. Porco, Wilma A. Stolk, Martin Walker, Sake J. de Vlas, for the NTD Modelling Consortium
Policy Platform | published 09 Apr 2020 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0008033

PLoS One
http://www.plosone.org/
[Accessed 11 Apr 2020]

Disparities in parental awareness of children’s seasonal influenza vaccination recommendations and influencers of vaccination
Jane Tuckerman, Nigel W. Crawford, Helen S. Marshall
Research Article | published 09 Apr 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0230425

PNAS – Proceedings of the National Academy of Sciences of the United States of America
http://www.pnas.org/content/early/
[Accessed 11 Apr 2020]

Effectiveness of convalescent plasma therapy in severe COVID-19 patients
Kai Duan, Bende Liu, Cesheng Li, Huajun Zhang, Ting Yu, Jieming Qu, Min Zhou, Li Chen, Shengli Meng, Yong Hu, Cheng Peng, Mingchao Yuan, Jinyan Huang, Zejun Wang, Jianhong Yu, Xiaoxiao Gao, Dan Wang, Xiaoqi Yu, Li Li, Jiayou Zhang, Xiao Wu, Bei Li, Yanping Xu, Wei Chen, Yan Peng, Yeqin Hu, Lianzhen Lin, Xuefei Liu, Shihe Huang, Zhijun Zhou, Lianghao Zhang, Yue Wang, Zhi Zhang, Kun Deng, Zhiwu Xia, Qin Gong, Wei Zhang, Xiaobei Zheng, Ying Liu, Huichuan Yang, Dongbo Zhou, Ding Yu, Jifeng Hou, Zhengli Shi, Saijuan Chen, Zhu Chen, Xinxin Zhang, and Xiaoming Yang
PNAS first published April 6, 2020. https://doi.org/10.1073/pnas.2004168117

Public Health
Volume 181 Pages 1-204 (April 2020)
https://www.sciencedirect.com/journal/public-health/vol/181/suppl/C

Research article Abstract only
Pharmaceutical industry-led partnerships focused on addressing the global burden of non-communicable diseases: a review of Access Accelerated
C.A. Umeh, P.C. Rockers, R.O. Laing, O. Wagh, V.J. Wirtz
Pages 73-79

Science
10 April 2020 Vol 368, Issue 6487
http://www.sciencemag.org/current.dtl

Editorial
G20 leaders must answer to COVID-19
By Caroline Atkinson
Science10 Apr 2020

Science
10 April 2020 Vol 368, Issue 6487
http://www.sciencemag.org/current.dtl

In-Depth
United States aims to curb vaccination injury payouts
By Meredith Wadman
Science10 Apr 2020 : 121-122 Restricted Access
Proposal would make it harder to get compensated for shoulder injuries after misplaced injections.
Summary
The Trump administration is quietly moving to reverse a rule that made it much easier for people who sustain serious shoulder injuries from improperly injected vaccines to win cash compensation from the federal government. Such claims have surged since 2017, when the Obama administration made it easier to win payouts for shoulder injuries. Some physicians support the proposal, arguing that it’s not vaccines but poor injection technique that causes these debilitating injuries. But vaccine injury lawyers and the vaccine injured are pushing back, noting that the 1986 law that established the $4 billion Vaccine Injury Compensation Program nowhere excludes injuries due to errors by those injecting vaccines.

Science
10 April 2020 Vol 368, Issue 6487
http://www.sciencemag.org/current.dtl

Policy Forum
Embrace experimentation in biosecurity governance
By Sam Weiss Evans, Jacob Beal, Kavita Berger, Diederik A. Bleijs, Alessia Cagnetti, Francesca Ceroni, Gerald L. Epstein, Natàlia Garcia-Reyero, David R. Gillum, Graeme Harkess, Nathan J. Hillson, Petra A. M. Hogervorst, Jacob L. Jordan, Geneviève Lacroix, Rebecca Moritz, Seán S. ÓhÉigeartaigh, Megan J. Palmer, Mark W. J. van Passel
Science10 Apr 2020 : 138-140 Restricted Access
We must rethink and test assumptions about relationships among biological research, security, and society

Systematic Reviews
https://systematicreviewsjournal.biomedcentral.com/articles
[Accessed 11 Apr 2020]

Traditional Chinese herbal medicine for treating novel coronavirus (COVID-19) pneumonia: protocol for a systematic review and meta-analysis
A new type of coronavirus, novel coronavirus (COVID-19), is causing an increasing number of cases of pneumonia and was declared a Public Health Emergency of International Concern by the World Health Organizati…
Authors: Yuxi Li, Xiaobo Liu, Liuxue Guo, Juan Li, Dongling Zhong, Yonggang Zhang, Mike Clarke and Rongjiang Jin
Citation: Systematic Reviews 2020 9:75
Content type: Protocol
Published on: 8 April 2020

Vaccine
Volume 38, Issue 17 Pages 3295-3404 (9 April 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/17

Research article Open access
HPV infections among young MSM visiting sexual health centers in the Netherlands: Opportunities for targeted HPV vaccination
Petra J. Woestenberg, Birgit H.B. van Benthem, Johannes A. Bogaards, Audrey J. King, … Christian J.P.A. Hoebe
Pages 3321-3329

Vaccine
Volume 38, Issue 17 Pages 3295-3404 (9 April 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/17

Research article Abstract only
Psychosocial determinants of pertussis and influenza vaccine uptake in pregnant women: A prospective study
Hassen Mohammed, Claire T. Roberts, Luke E. Grzeskowiak, Lynne Giles, … Helen S. Marshall
Pages 3358-3368

Vaccine
Volume 38, Issue 17 Pages 3295-3404 (9 April 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/17

Research article Open access
Cost-effectiveness of inactivated influenza vaccination in children with medical risk conditions in the Netherlands
Steffie K. Naber, Patricia C.J.L. Bruijning-Verhagen, Marieke L.A. de Hoog, Anoukh van Giessen
Pages 3387-3396

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 11 Apr 2020)

Open Access Article
The Impact of Narrative Strategy on Promoting HPV Vaccination among College Students in Korea: The Role of Anticipated Regret
by Jarim Kim
Vaccines 2020, 8(2), 176; https://doi.org/10.3390/vaccines8020176 (registering DOI) – 10 Apr 2020
Abstract
Human papillomavirus (HPV) vaccine hesitancy contributes to unsatisfactory vaccination coverage in Korea despite its high efficacy in preventing various diseases including cervical cancer. To enhance HPV vaccine uptake, effective communication with the public is key. To develop effective health promotion messages, this study examined the effects of message format on attitudes and intentions toward HPV vaccination, specifically focusing on anticipated action and inaction regrets. It employed a randomized experimental message design format (narrative versus didactic messages). A total of 222 Korean undergraduate students who had not received the HPV shot participated in the experiment. The results showed that didactic messages produce greater anticipated inaction regret, which further influences HPV vaccination attitudes and behaviors. Anticipated regret could potentially explain mixed narrative effects across health behaviors as described in existing literature

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 11 Apr 2020)

Open Access Article
Anal Human Papillomavirus Infection among MSM Attending University in China: Implications for Vaccination
by Song Fan , Peiyang Li , Lin Ouyang , Tanwei Yuan , Hui Gong , Yi Ding , Zhenzhou Luo , Guohui Wu , Maohe Yu and Huachun Zou
Vaccines 2020, 8(2), 175; https://doi.org/10.3390/vaccines8020175 – 09 Apr 2020
Abstract
Men who have sex with men (MSM) attending university are a high-risk population for human papillomavirus (HPV) infection and are a neglected population of HPV vaccination programs in China. To provide evidence for HPV vaccination policies, we conducted this study to examine the prevalence and factors associated with anal HPV infection among MSM attending university in China. A self-administered online questionnaire was conducted to collect information on social demographics and sexual behaviors. A self-collected rectal swab specimen was collected to test for 37 HPV types. A total of 426 participants were tested for HPV. The median age was 20 years. HPV prevalence was 37.5% for any type, 29.8% for nine-valent vaccine types, 24.6% for four-valent vaccine types, 11.5% for HPV-16/18, and 15.7% for HPV-6/11. Men enrolled in a technical diploma, living in Northern China, having more than two sex partners, being bottom or versatile in anal sex, and having a human immunodeficiency virus (HIV) testing history were more likely to have positive anal HPV of any type. Our study found a high prevalence of anal HPV infection among MSM attending university in China, with HPV vaccine-preventable types being the most popular types in this group. Thus, our findings highlight the urgency of promoting HPV vaccination among teenage MSM.

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 11 Apr 2020)

Open Access Review
Utility of Healthcare System-Based Interventions in Improving the Uptake of Influenza Vaccination in Healthcare Workers at Long-Term Care Facilities: A Systematic Review
by Angela Bechini , Chiara Lorini , Patrizio Zanobini , Francesco Mandò Tacconi , Sara Boccalini , Maddalena Grazzini , Paolo Bonanni and Guglielmo Bonaccorsi
Vaccines 2020, 8(2), 165; https://doi.org/10.3390/vaccines8020165 – 05 Apr 2020
Viewed by 230
Abstract
Healthcare workers (HCWs) in long-term care facilities (LTCFs) can represent a source of influenza infection for the elderly. While flu vaccination coverage (VC) is satisfactory in the elderly, HCWs are less likely to be vaccinated. There is no definitive evidence on which types of healthcare system-based interventions at LTCFs would be more useful in improving the vaccination uptake among HCWs. We performed a systematic review in different databases (Pubmed, Cochrane Database of Systematic Reviews, Health Evidence, Web of Science, Cinahl) to provide a synthesis of the available studies on this topic. Among the 1177 articles screened by their titles and abstracts, 27 were included in this review. Most of the studies reported multiple interventions addressed to improve access to vaccination, eliminate individual barriers, or introduce policy interventions. As expected, mandatory vaccinations seem to be the most useful intervention to increase the vaccination uptake in HCWs. However, our study suggests that better results in the vaccination uptake in HCWs were obtained by combining interventions in different areas. Educational campaigns alone could not have an impact on vaccination coverage. LTCFs represent an ideal setting to perform preventive multi-approach interventions for the epidemiological transition toward aging and chronicity.

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

No new digest content identified.

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 11 Apr 2020
Ideas
Think 168,000 Ventilators Is Too Few? Try Three.
Why COVID-19 Might Hit African Nations Hardest
The coronavirus has been slow to spread across Africa. But a wave may soon hit, and health-care workers are bracing for disaster.
April 10, 2020
Graeme Wood, Staff writer

BBC
http://www.bbc.co.uk/
Africa
Coronavirus: Africa will not be testing ground for vaccine, says WHO
6 April 2020
The head of the World Health Organization (WHO) has condemned as “racist” the comments by two French doctors who suggested a vaccine for the coronavirus could be tested in Africa.
“Africa can’t and won’t be a testing ground for any vaccine,” said Director General Dr Tedros Adhanom Ghebreyesus.
The doctors’ remarks during a TV debate sparked outrage, and they were accused of treating Africans like “human guinea pigs”.
One of them later issued an apology.
When asked about the doctors’ suggestion during the WHO’s coronavirus briefing, Dr Tedros became visibly angry, calling it a hangover from the “colonial mentality”.
“It was a disgrace, appalling, to hear during the 21st Century, to hear from scientists, that kind of remark. We condemn this in the strongest terms possible, and we assure you that this will not happen,” he said.

The Economist
http://www.economist.com/
Accessed 11 Apr 2020
[No new, unique, relevant content]

Financial Times
http://www.ft.com/home/uk
Accessed 11 Apr 2020
Coronavirus
Mystery surrounds ‘cured’ patients who tested positive
…. Jerome Kim, an immunology expert and director-general of the International Vaccine Institute, said experts did not yet have a definitive understanding of Covid-19 and that changes might be required in how…
April 10, 2020

Forbes
http://www.forbes.com/
11 April 2020
The World 2.0: Is Coronavirus The Great Disrupter?
The coronavirus pandemic shows signs that it may be a great disrupter, reshuffling economic and social structures. But unlike past recessions, this one has a discrete cause and a finite, if not predictable, timeline that will come to an end. There is nothing fundamentally wrong with our economy.
By Jason B. Freeman Contributor

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 11 Apr 2020
[No new, unique, relevant content]

Foreign Policy
http://foreignpolicy.com/
Accessed 11 Apr 2020
Argument |
Poor Countries Need to Think Twice About Social Distancing
Policies imposed in rich countries to fight the coronavirus could have adverse effects in low-income nations—potentially endangering more lives than they save.
Ahmed Mushfiq Mobarak, Zachary Barnett-Howell
April 10, 2020,

The Guardian
http://www.guardiannews.com/
Accessed 11 Apr 2020
The super-rich
Call for super-rich to donate more to tackle coronavirus pandemic
While some billionaires have pledged vast chunks of their wealth others have been criticised for not giving enough, or even at all
Rupert Neate
Sat 11 Apr 2020 03.00 EDT

New Yorker
http://www.newyorker.com/
Accessed 11 Apr 2020
Protocols
April 20, 2020 Issue
Who Gets a Ventilator?
A New York State task force devised a set of guidelines to help doctors decide how to apportion ventilators, but the state has failed to issue any protocols for allocating the devices to coronavirus patients.
By Tyler Foggatt

Annals of Medicine
How Anthony Fauci Became America’s Doctor
An infectious-disease expert’s long crusade against some of humanity’s most virulent threats.
By Michael Specter

New York Times
http://www.nytimes.com/
Accessed 11 Apr 2020
Europe
Could the New Coronavirus Weaken ‘Anti-Vaxxers’?
An American mother-of-three is a long-time member of “anti-vaxxer” groups online: a small but vocal global community that believes vaccines are a dangerous con and refuse to immunize themselves or their children.
April 11 By Reuters

Pro Football
No Vaccine, No American Fans in Stands-Says Poll
North America’s sports leagues may be itching to return to action but 72% of those who responded to a Seton Hall poll said they would not feel safe to attend games until a vaccine for the novel coronavirus is developed.
April 9 By Reuters

Washington Post
https://www.washingtonpost.com/
Accessed 11 Apr 2020
[No new, unique, relevant content]

Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 11 Apr 2020
Future Development
New hope for fixing health system failures to prevent and treat cervical cancer
Andrea Thoumi, Lillian Zhu, Rachel Mundaden, and Karina Moreno Bueno
Friday, April 10, 2020

Center for Global Development [to 11 Apr 2020]
http://www.cgdev.org/page/press-center
Selected Publications, News and Events
April 8, 2020
How are International Development Agencies Responding to the COVID-19 Crisis?
COVID-19 has become the biggest stress test in decades for international cooperation. Will donors be able to deliver effective, sustainable development for the world’s poor while also scrambling to support health systems cope with this crisis?
Mikaela Gavas, Rachael Calleja and Andrew Rogerson

April 7, 2020
Faced with COVID-19, the Humanitarian System Should Rethink its Business Model
This is a crisis of truly global scale and it will place enormous constraints on traditional humanitarian operations.
Jeremy Konyndyk and Patrick Saez

CSIS
https://www.csis.org/
Accessed 11 Apr 2020
Transcript
Next Steps for the COVID-19 Response
April 8, 2020

Transcript
Ron Klain – What This Pandemic Has Taught Us
April 8, 2020

Council on Foreign Relations
http://www.cfr.org/
Accessed 11 Apr 2020
[No new relevant content]

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 11 Apr 2020
[No new relevant content]

Milestones :: Perspectives :: Research
 
 
COVID-19 R&D
 

IFPMA Backgrounder – COVID-19
03 April 2020
[Excerpts]
… Vaccine development
While vaccines and small molecule treatments are approved through different regulatory pathways and their development programs vary, they generally both must complete three phases of clinical trials. However, there are differences in the data required to show the safety of vaccines and the size of clinical trials for vaccines relative to small molecules.
Experts are hoping it will take as little as 12 to 18 months before there is a vaccine available.   This is a best-case estimate that assumes one or two of the first few vaccines that enter development will be successful. Typically, only approximately one in ten experimental vaccines make it all the way through to regulatory approval. Therefore, the more companies taking different approaches to find a vaccine, the more “shots on goal” and significantly greater chances of success.

:: CEPI and GSK will collaborate to help the global effort to develop a vaccine for the novel coronavirus. GSK is making its adjuvant technology available to support rapid development of candidate vaccines and is working with The University of Queensland, Australia.

:: CSL Limited/ Seqirus is providing scientific and technical expertise and its established MF59® adjuvant technology to the University of Queensland in Australia to help fast-track the development of their CEPI-funded COVID-19 vaccine candidate, which uses novel molecular-clamp technology.

:: GSK announced it would partner with the Chinese biotech company Clover Biopharmaceuticals. Under the partnership, GSK will provide Clover with its proprietary adjuvants – compounds that enhance the effectiveness of vaccines. By mid-March, GSK expanded their collaborations and is now working with five partner companies and research groups across the world, including in the USA and China.

:: Johnson & Johnson expanded its collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of U.S. Department of Health & Human Services (HHS), and established a new collaboration with Beth Israel Deaconess Medical Center (BIDMC), to accelerate development of a potential novel coronavirus vaccine.

:: Johnson & Johnson announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine.

:: Pfizer and BioNTech have entered into a partnership to jointly develop BioNTech’s mRNA-based vaccine candidate BNT162 to prevent COVID-19 infection. The collaboration aims to accelerate global development of BNT162, which is expected to enter clinical testing by the end of April 2020.

:: Sanofi announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), to advance a novel COVID-19 vaccine candidate. Work is underway to leverage previous development of a SARS vaccine candidate using Sanofi’s recombinant DNA technology. Sanofi is also coordinating with the Coalition for Epidemic Preparedness Innovations (CEPI) and sharing its vaccine R&D experience and expertise to advance vaccine solutions.

:: Sanofi and U.S. company Translate Bio announced plans to collaborate on developing a vaccine to treat the coronavirus. The companies said Translate Bio would work on discovering, designing, and manufacturing a number of SARS-CoV-2 vaccine candidates, while Sanofi would provide its expertise in the field of vaccines and support from its research networks.

Treatment development
Currently a number of existing and new treatments are in various research phases and clinical trials to test their efficiency and safety for treating COVID-19. Listed below is a snapshot of the different areas of research focused on finding an effective treatment.

:: AbbVie announced it is partnering with global authorities to determine the effectiveness of HIV drugs in treating COVID-19. AbbVie is supporting clinical studies and basic research with lopinavir/ritonavir, working closely with European health authorities and the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention, National Institutes of Health and the Biomedical Advanced Research and Development Authority to coordinate these efforts.
International Ch. des Mines 9 Tel: +41 22 338 32 00 Federation of P.O. Box 195 Fax: +41 22 338 32 99 Pharmaceutical 1211 Geneva 20 http://www.ifpma.org Manufacturers & Switzerland Associations

:: AstraZeneca’s Research and Development (R&D) teams have also been working expeditiously to identify monoclonal antibodies to progress towards clinical trial evaluation as a treatment to prevent COVID-19. More than 50 virology, immunology, respiratory, and protein engineering experts across research, clinical, regulatory, and manufacturing are placing the highest priority on developing a treatment to minimise the global impact of the disease.

:: Eli Lilly and AbCellera (Canadian biotech firm) have entered into an agreement to co-develop antibody products for the treatment and prevention of COVID-19. The collaboration will leverage AbCellera’s rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform (P3) Program, and Lilly’s global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies.

:: EFPIA is working with the Innovative Medicines Initiative (IMI) on potential actions to support collaborative research programs in order to fast-track the development of therapeutics.

:: Gilead has initiated two Phase 3 clinical trials of remdesivir in countries with high prevalence of COVID-19. The company is also supporting two Phase 3 trials in China and a global Phase 2 trial led by the U.S. National Institute of Allergy and Infectious Diseases. Gilead donated drug and provided scientific input for these studies. Gilead has provided remdesivir to physicians for compassionate use to treat several hundred severely ill patients with confirmed COVID-19, and has accelerated manufacturing of remdesivir at risk, in anticipation of potential future supply needs.

:: GSK is entering into the new collaborative research effort, the COVID-19 Therapeutics Accelerator. The aim of the Accelerator is to bring pharmaceutical companies and expert academic institutions into coordinated research programs, with the aim of bringing the most promising molecules forward that could be used to treat cases of COVID-19. GSK will contribute by making available compounds from its libraries for screening for activity against COVID-19. In addition, GSK is evaluating its marketed pharmaceutical products and medicines in development to determine if any could be used beyond their current indications in response to the pandemic. Further, GSK is evaluating options to make available specialised laboratory space to help in research and testing of COVID-19.

:: Ipsen donates €2 million to the Institut Pasteur to support research on COVID-19. Since January, the Institut Pasteur has devoted a portion of its research to understanding the emerging COVID-19 virus, in terms of epidemiology, biological characteristics, pathogenicity.

:: Johnson & Johnson, in partnership with the Rega Institute for Medical Research, University of Leuven (Belgium), are working to identify existing or new compounds with antiviral activity against COVID-19 that could contribute to providing immediate relief to the current outbreak.

:: Merck, as part of the global effort to investigate potential therapeutics for COVID-19 and their support of independent research, recently donated a supply of interferon beta-1a (Rebif®) to the French Institut National de la Santé et de la Recherche Médicale (INSERM) following a request for use in a clinical trial. To date, Merck’s interferon beta-1a is not approved by any regulatory authority for the treatment of COVID-19 or for use as an antiviral agent.

:: Novartis announced that it has entered new collaborative research efforts such as the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard, as well as a COVID-19 directed partnership organized by the Innovative Medicines Initiative. Novartis is contributing by making available several compounds from its libraries that are considered suitable for in vitro antiviral testing. In addition, the company is rapidly evaluating other existing products to see if any could be utilized beyond their approved indications in response to the pandemic.

:: Novartis plans to initiate a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi® (ruxolitinib) for treatment of a type of severe immune overreaction called cytokine storm that can lead to life-threatening respiratory complications in patients with COVID-19.

:: Pfizer announced that it completed a preliminary assessment of certain antiviral compounds that were previously in development and that inhibited the replication of coronaviruses similar to the one causing COVID-19 in cultured cells. Pfizer is engaging with a third party to screen these compounds under an accelerated timeline and expects to have the results back by the end of March.

:: Pfizer also outlined a detailed 5-point action plan to battle COVID-19. The plan includes a commitment to sharing its clinical development and regulatory expertise to support other smaller biotech companies that are screening compounds or existing therapies for activity against the virus causing COVID-19.

:: Regeneron Pharmaceuticals announced an expanded agreement with the U.S. Department of Health and Human Services (HHS) to develop new treatments combating the novel coronavirus.

:: Regeneron Pharmaceuticals and Sanofi SA started a clinical program evaluating Kevzara, originally a drug to treat arthritis, in patients hospitalized with severe COVID-19. Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19 infection.

:: Roche’s Actemra was approved by China on March 5 to treat Covid-19 patients with lung complications. Roche has donated nearly $2m-worth of Actemra to China to help the country manage the COVID-19 outbreak”. Actemra has been on the European market since 2010 for treatment of several kinds of arthritis.

:: Roche announced that they are working with the Food & Drug Administration (FDA) to initiate a Phase III clinical trial to evaluate the safety and efficacy of Actemra in hospitalised adult patients with severe COVID-19 pneumonia. This is the first global

study of Actemra in this setting and is expected to begin enrolling as soon as possible in early April with a target of approximately 330 patients globally, including the US.

:: Takeda announced that it is initiating the development of a drug to treat people infected with the novel coronavirus. The experimental drug would be derived from the blood of coronavirus patients who have recovered from the respiratory disease. In parallel, Takeda is also exploring whether currently marketed and pipeline products may be an effective treatment option for infected patients.

Diagnostics

Rolling out diagnostics to detect whether patients are genuinely infected with the new coronavirus is a key step in preventing or slowing its spread. However, the rapid spread of COVID-19 has drastically increased the demand for testing kits around the world, especially in the United States and Europe, and governments are trying to ramp up their testing capacities.

:: AstraZeneca is accelerating the development of its diagnostic testing capabilities to scale-up screening and is also working in partnership with governments on existing screening programmes to supplement testing.

:: Roche announced that the FDA issued an Emergency Use Authorization for its diagnostic kit cobas® SARS-CoV-2 Test, advancing coronavirus testing to meet urgent medical needs. Roche is committed to delivering as many tests as possible and is going to the limits of production capacity.

:: Takeda is partnering with public entities and other pharmaceutical companies through the Innovative Medicines Initiative (IMI) in Europe to leverage collective expertise in the hope of developing diagnostics for COVID-19 as well as inhibitors to help prevent future outbreaks…

::::::

::::::

WHO :: Global research on coronavirus disease (COVID-19)
:: International Clinical Trials Registry Platform
:: COVID-19 Emergency Use Listing Procedure (EUL)
:: “Solidarity” clinical trial for COVID-19 treatments – WHO
“Solidarity” is an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners.

The Solidarity trial will compare four treatment options against standard of care, to assess their relative effectiveness against COVID-19. By enrolling patients in multiple countries, the Solidarity trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival. Other drugs can be added based on emerging evidence.

Until there is sufficient evidence, WHO cautions against physicians and medical associations recommending or administering these unproven treatments to patients with COVID-19 or people self-medicating with them. WHO is concerned by reports of individuals self-medicating with chloroquine and causing themselves serious harm. WHO guidance on compassionate use can be found here. [below]
WHO :: Off-label use of medicines for COVID-19
Scientific brief
31 March 2020
No pharmaceutical products have yet been shown to be safe and effective for the treatment of COVID-19. However, a number of medicines have been suggested as potential investigational therapies, many of which are now being or will soon be studied in clinical trials, including the SOLIDARITY trial co-sponsored by WHO and participating countries.

In many countries, doctors are giving COVID-19 patients medicines that have not been approved for this disease. The use of licensed medicines for indications that have not been approved by a national medicines regulatory authority is considered “off-label” use. The prescription of medicines for off-label use by doctors may be subject to national laws and regulations. All health care workers should be aware of and comply with the laws and regulations governing their practice. Further, such prescribing should be done on a case-by-case basis. Unnecessary stockpiling and the creation of shortages of approved medicines that are required to treat other diseases should be avoided.

It can be ethically appropriate to offer individual patients experimental interventions on an emergency basis outside clinical trials, provided that no proven effective treatment exists; it is not possible to initiate clinical studies immediately; the patient or his or her legal representative has given informed consent; and the emergency use of the intervention is monitored, and the results are documented and shared in a timely manner with the wider medical and scientific community.

The decision to offer a patient an unproven or experimental treatment is between the doctor and the patient but must comply with national law. Where it is possible and feasible for the treatment to be given as part of a clinical trial, this should be done unless the patient declines to participate in the trial.

If it is not possible to give the treatment as part of a clinical trial, appropriate records of the use of the medicine must be kept, in compliance with national law, and outcomes for patients should be monitored and recorded.

If early results from an unproven or experimental treatment are promising, the treatment should be studied in the context of a formal clinical trial to establish its safety, efficacy, risks, and benefits.

References
World Health Organization. Monitored emergency use of unregistered and experimental interventions (MEURI), http://www.who.int/ethics/publications/infectious-disease-outbreaks/en/.

WHO continues to monitor the situation closely for any changes that may affect this interim guidance. Should any factors change, WHO will issue a further update. Otherwise, this scientific brief will expire 2 years after the date of publication.

WHO reference number:  WHO/2019-nCoV/Sci_Brief/Off-label_use/2020.1
 
::::::
::::::
Johnson & Johnson Announces a Lead Vaccine Candidate for COVID-19; Landmark New Partnership with U.S. Department of Health & Human Services; and Commitment to Supply One Billion Vaccines Worldwide for Emergency Pandemic Use

Mar 30, 2020, 07:22 ET

:: Johnson & Johnson and BARDA Together Commit More than $1 Billion to Novel Coronavirus Vaccine Research and Development; Company Expects to Initiate Phase 1 Human Clinical Studies of Vaccine Candidate at Latest by September 2020

:: Johnson & Johnson Will Establish New U.S. Vaccine Manufacturing Capabilities and Additional Production Capacity Outside the U.S. to Begin Production at Risk to Help Ensure Global Vaccine Supply

NEW BRUNSWICK, N.J., March 30, 2020 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) (the Company) today announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine. The Company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process.

Through a landmark new partnership, BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. Johnson & Johnson will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts. Separately, BARDA and the Company have provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against the novel coronavirus.

As part of its commitment, Johnson & Johnson is also expanding the Company’s global manufacturing capacity, including through the establishment of new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries. The additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses of a safe and effective vaccine globally. The Company plans to begin production at risk imminently and is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.

Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson, said, “The world is facing an urgent public health crisis and we are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible. As the world’s largest healthcare company, we feel a deep responsibility to improve the health of people around the world every day. Johnson & Johnson is well positioned through our combination of scientific expertise, operational scale and financial strength to bring our resources in collaboration with others to accelerate the fight against this pandemic.”

Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, “We greatly value the U.S. government’s confidence and support for our R&D efforts. Johnson & Johnson’s global team of experts has ramped up our research and development processes to unprecedented levels, and our teams are working tirelessly alongside BARDA, scientific partners, and global health authorities. We are very pleased to have identified a lead vaccine candidate from the constructs we have been working on since January. We are moving on an accelerated timeline toward Phase 1 human clinical trials at the latest by September 2020 and, supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021.”…

 
::::::
::::::
 
Medical Product Alert N°3/2020
Falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19
31 March 2020   News release  Geneva

This Medical Product Alert warns consumers, healthcare professionals, and health authorities against a growing number of falsified medical products that claim to prevent, detect, treat or cure COVID-19. 

The Coronavirus disease (COVID-19) pandemic (caused by the virus SARS-CoV-2) has increased demand for medicines, vaccines, diagnostics and reagents, all related to COVID-19, creating an opportunity for ill-intended persons to distribute falsified medical products

Due diligence is required from all actors in the procurement, use and administration of medical products, in particular those affected by the current crisis of, or related to, COVID-19. 

1. FALSIFIED IN VITRO DIAGNOSTICS AND LABORATORY REAGENTS 

WHO has received multiple reports regarding falsified in vitro diagnostics (IVDs) and laboratory reagents for the detection of SARS-CoV-2. Please refer to WHO’s Emergency Use Listing for a list of diagnostics approved for clinical use by WHO. To date, eight countries (Australia, Brazil, Canada, PR China, Russian Federation, Singapore, Republic of Korea, United States of America) have listed IVDs for COVID-19 diagnosis based on expedited regulatory assessments. Please note that, in the European Union, regulatory compliance for SARS-CoV-2 diagnostics are self-declared by the manufacturer.

To assist Member States and stakeholders, WHO has published the links to these emergency lists, together with contact details. These links provide information on IVDs authorized for use in the jurisdictions of the International Medical Device Regulators Forum, as well as policies and guidance. WHO will provide updated versions as new information becomes available.

End-users are encouraged to check the labelling against the information posted by regulatory authorities upon listing to ensure they are in possession of the genuine product. This information might include product name, product code, expiry date, instructions for use and manufacturer details.

Unregulated websites supplying medicines and/or vaccines, particularly those concealing their physical address or landline telephone number, are frequently the source of unlicensed, substandard and falsified medical products. WHO has been made aware of various unregistered websites claiming that products on sale can treat or prevent COVID-19. Such products are likely to be falsified medicines. In addition, some websites may appear to provide easy access to legitimate medicines that are otherwise not readily available. End-buyers and consumers should be especially wary of such online scams and exert due diligence when purchasing any medical product, whether online or not.

2. FALSIFIED MEDICINES AND VACCINES

At this stage, WHO does not recommend any medicines to treat or cure COVID-19. However, the SOLIDARITY trial, led by WHO, is reviewing potential treatments for COVID-19.

WHO requests increased vigilance from national health authorities, healthcare professionals, members of the public and supply chain stakeholders worldwide to prevent the distribution of these falsified medical products. Increased vigilance should focus on hospitals, clinics, health centres, clinical laboratories, wholesalers, distributors, pharmacies and any other suppliers of medical products. All medical products must be obtained from authentic and reliable sources. Their authenticity and condition of the product should be carefully checked. Consumers are advised to seek advice from a healthcare professional in case of doubt.

National health authorities are requested to immediately notify WHO if these falsified products are discovered in their country. If you have any information concerning the manufacture, distribution, or supply of these products, please contact rapidalert@who.int

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

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
IGBA urgent recommendations to keep medicine supply chains flowing
27 March 2020
The current operating model of medicines supply requires transparent global collaboration to provide access to medicines for patients around the world.

IGBA firmly believes that any restrictions on the export of pharmaceutical products are counter-productive in responding to a global public health crisis. We therefore discourage countries from implementing any policies that could disrupt the pharmaceutical supply chain, including the use of export bans and stockpiling measures. To do so would hamper the industry’s response to COVID-19. If countries impose such export restrictions, however, communication must be clear on their scope to prevent an escalation of reactive measures publicly.

To keep medicine supply chains flowing and to avoid shortages, it is critical to:
:: support global cooperation, which is essential to maximise production levels for all countries under WHO leadership, involving Health Ministries and industry;
:: keep international borders open, secure trade flows and oppose export bans for medicines and the key ingredients for their manufacture;
:: maintain air freight capacity at predictable and reasonable cost by making use of available commercial aircraft not currently in use or banned from flying. Military planes could also be :: reserve cargo capacity to transport medicines, active pharmaceutical ingredients, intermediates, key starting materials and medical equipment;
:: ensure that airports remain open for these essential goods;
:: coordinate the approach to maintain the airport traffic flow in all global pharmaceutical hubs (such as the EU, India, US and China) – creating open routes or “green lanes” for these essential goods between countries around the world.

As governments take measures to protect their populations from the unrestricted spread of COVID-19, clear coordinated communication is critical to ensure appropriate action by the global community. IGBA therefore welcomes statements affirming commitment to medicines access and supply chain connectivity by the G20 and the joint ministries of Australia, Brunei Darussalam, Canada, Chile, Myanmar, New Zealand and Singapore, recognizing the importance of collaboration and solidarity.

EMERGENCIES

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

Editor’s Note:
We certainly recognize the velocity of global developments in the COVID-19 pandemic. While we have concentrated the most current key reports just below, COVID-19 announcements, analysis and commentary will be found throughout this issue, in all sections.
Beyond the considerable continuing coverage in the global general media, the WHO’s authoritative guidance is available here:
:: Daily WHO situation reports here: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports

:: WHO Coronavirus disease (COVID-2019) daily press briefings here: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/media-resources/press-briefings

::::::
 
Situation report – 75 [WHO]
Novel Coronavirus (COVID-19)
4 April 2020
[Excerpts]
SITUATION IN NUMBERS
Globally
1 051 635 confirmed (79 332)
56 985 deaths (6664)

Western Pacific Region
110 362 confirmed (1432)
3809 deaths (49)

European Region
583 141 confirmed (41 333)
42 334 deaths (5231)

South-East Asia Region
6528 confirmed (647)
267 deaths (22)

Eastern Mediterranean Region
65 903 confirmed (3667)
3592 deaths (154)

Region of the Americas
279 543 confirmed (32 070)
6802 deaths (1202)

African Region
5446 confirmed (183)
170 deaths (6)
 

WHO RISK ASSESSMENT
Global Level – Very High

HIGHLIGHTS

:: One new country/territory/area reported cases of COVID-19 in the past 24 hours: Bonaire, Sint Eustatius and Saba.

:: As worldwide cases climb above 1 million and deaths over 50 000, Dr Tedros stressed that the best way for countries to end restrictions and ease their economic effects was to attack the virus with an aggressive and comprehensive package of measures. His speech can be found here.

:: WHO has released new technical guidance recommending universal access to public hand hygiene stations and making their use obligatory on entering and leaving any public or private commercial building and any public transport facility. It also recommends that healthcare facilities improve access to and practice of hand hygiene. Find more here.

:: WHO/Europe has received a €30 million contribution from the European Commission for 6 WHO European Region Member States – Armenia, Azerbaijan, Belarus, Georgia, the Republic of Moldova and Ukraine – to meet immediate needs in their responses to COVID-19. More information is available here.

Emergencies

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

Ebola Outbreak in DRC 86: 31 March 2020
[Excerpts]
Situation Update WHO Health Emergencies Programme Page 2
There have been no new cases of Ebola virus disease (EVD) reported since 17 February 2020. The last individual confirmed to have Ebola was discharged from an Ebola Treatment Centre on 3 March after recovering and testing negative for the virus twice. On 9 March, the last contacts finished their follow-up period. These developments are significant milestones in this outbreak. However, there is still a high risk of re-emergence of EVD, and it is critical to maintain response activities to rapidly detect and respond to any new cases, and to continue ongoing support and health monitoring operations for EVD survivors – as outlined in the WHO recommended criteria for declaring the end of the EVD outbreak.
There is ongoing surveillance, pathogen detection, and clinical management activities in previously affected areas, including alert validation, rapid diagnosis of suspected cases, and building partnerships with community members to strengthen investigation of potential EVD deaths in communities. Insecurity remains a challenge in continuing response activities, which could delay the detection of potential flare-ups.

…Conclusion
Due to challenges related to continued insecurity and population displacement in previous hotspots and potential shortages of resources required to carry out response activities amidst other local and global emergencies, there remains a high risk of re-emergence of EVD in the period leading up to the declaration of the end of the outbreak, as well as for several months following that declaration. In order to mitigate the risk of re-emergence, it is critical to maintain surveillance and rapid detection and response capacities, prioritize survivor care, and maintain cooperative relationships with survivors’ associations.

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

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 01 April 2020
Summary of new viruses this week (AFP cases and ES positives):
:: Afghanistan: one WPV1 case
:: Pakistan: four WPV1 cases, nine WPV1 positive environmental samples and eight cVDPV2 cases
:: Benin: one cVDPV2 case
:: Democratic Republic of the Congo (DR Congo) – two cVDPV2 cases
:: Ethiopia: five cVDPV2 cases
:: Ghana: five cVDPV2 cases and four cVDPV2 positive environmental samples
:: Malaysia: 15 cVDPV1 positive environmental samples and four cVDPV2 positive environmental samples
:: Togo: five cVDPV2 cases

::::::

Call to action to support COVID-19 response
Polio Oversight Board Statement
02/04/2020
The COVID-19 pandemic response requires worldwide solidarity and an urgent global effort.  The Global Polio Eradication Initiative (GPEI) stands ready to respond.

GPEI’s response to COVID-19 is driven by two principles.  The first is our public health imperative to ensure that the polio programme fully plays its part in the COVID-19 response, supported by our second, underlying principle that when the emergency ends we will be ready to end polio with urgency and determination.

GPEI assets at service of COVID-19 response
The Polio Oversight Board (POB) has agreed that for the next four to six months, GPEI programmatic and operational assets and human resources, from global to country level, will be made available to enable a strong response to COVID-19, while maintaining critical polio functions, such as surveillance and global vaccine supply management.

GPEI will continue to deploy polio-funded personnel to the COVID-19 response and make available coordination mechanisms, such as emergency operations centers, and physical assets such as transportation or IT hardware.  Through our extensive front-line worker networks in many countries, we will ensure the collection of information to provide evidence-informed guidance in line with WHO recommendations. At country level, the polio surveillance network is being trained on COVID-19 case detection, case and contact tracing, laboratory testing and data management.   Our data management systems and front-line staff are already ramping up action in many countries, and wherever the polio programme has a presence we will continue to serve the response.

GPEI will also seek assurances that when GPEI staff is supporting COVID-19 front line activities, they will be provided with the necessary training, materials, equipment and logistics support to do so safely, in line with infection prevention and control measures. The GPEI is conscious that women, who make up most caregivers and health workers, are likely to bear a heavier burden as the pandemic plays out in polio-affected countries. Their health and safety are a priority and we are working on ways to mitigate impact including making sure that their voices are heard in management and leadership positions.

Pause in immunization campaigns
All countries planning to conduct poliovirus preventative campaigns are advised to temporarily postpone these campaigns until the second half of 2020. Countries which were planning to conduct poliovirus outbreak response campaigns are advised to postpone these campaigns until 1 June 2020 and then reevaluate based on the status of the COVID-19 pandemic…

Download the full statement

::::::

WHO Grade 3 Emergencies [to 28 Mar 2020]

Democratic Republic of the Congo
:: Ebola Outbreak in DRC 86: 31 March 2020
[See Ebola above for detail]

Mozambique floods
:: World Health Organization: 10 cases of COVID-19 confirmed in Mozambique
02 April 2020

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 28 Mar 2020]
Iraq
:: The fight to contain COVID-19 in Iraq April 1, 2020

Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burkina Faso [in French] – No new digest announcements identified
Burundi – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Ethiopia – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Iran – No new digest announcements identified
Libya – No new digest announcements identified
Malawi – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Myanmar – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

::::::

WHO Grade 1 Emergencies [to 28 Mar 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: COVID-19 Update No. 04 – 2 April 2020
HIGHLIGHTS
:: Number of people confirmed by the Ministry of Health to have COVID-19: 16 (including two fatalities)
:: Areas of concern: Densely populated areas, notably Damascus/Rural Damascus and those living in camps, collective shelters and informal settlements in northeast Syria (NES), as well as areas where hostilities may be ongoing making sample collection more challenging.
:: Populations of concern: All groups are susceptible to the virus. However, the elderly (those 60 years and above) and people with underlying health conditions are particularly at risk; as are vulnerable refugee and IDP populations and healthcare workers with inadequate personal protective equipment (PPE).

Yemen
::  Yemen: Flash Floods in southern governorates – Flash Update No. 1 (As of 31 March 2020)

::::::

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.
CYCLONE IDAI and Kenneth – No new digest announcements identified
EBOLA OUTBREAK IN THE DRC – No new digest announcements identified

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

WHO & Regional Offices [to 28 Mar 2020]
3 April 2020 News release
WHO and UNICEF to partner on pandemic response through COVID-19 Solidarity Response Fund

2 April 2020 News release
IPA, WHO and UNICEF launch Read the World on International Children’s Book Day to support children and young people in isolation

31 March 2020 News release
Medical Product Alert N°3/2020
[See Milestones above for detail]

30 March 2020 News release
WHO releases guidelines to help countries maintain essential health services during the COVID-19 pandemic
The COVID-19 pandemic is straining health systems worldwide. The rapidly increasing demand on health facilities and health care workers threatens to leave some health systems overstretched and unable to operate effectively.
Previous outbreaks have demonstrated that when health systems are overwhelmed, mortality from vaccine-preventable and other treatable conditions can also increase dramatically. During the 2014-2015 Ebola outbreak, the increased number of deaths caused by measles, malaria, HIV/AIDS, and tuberculosis attributable to health system failures exceeded deaths from Ebola [1,2].
“The best defense against any outbreak is a strong health system,” stressed WHO Director-General Tedros Adhanom Ghebreyesus. “COVID-19 is revealing how fragile many of the world’s health systems and services are, forcing countries to make difficult choices on how to best meet the needs of their people.”
To help countries navigate through these challenges, the World Health Organization (WHO) has updated operational planning guidelines in balancing the demands of responding directly to COVID-19 while maintaining essential health service delivery, and mitigating the risk of system collapse. This includes a set of targeted immediate actions that countries should consider at national, regional, and local level to reorganize and maintain access to high-quality essential health services for all…

30 March 2020 Statement
Joint Statement by QU Dongyu, Tedros Adhanom Ghebreyesus and Roberto Azevedo, Directors-General of the Food and Agriculture Organization of the United Nations (FAO), the World Health Organization (WHO) and the World Trade Organization (WTO)

29 March 2020 Statement
Information sharing on COVID-19 [Taiwan]

::::::

Weekly Epidemiological Record, 3 April 2020, vol. 95, 14/15 (pp. 133–144)
Control of epidemic meningitis in countries in the African meningitis belt, 2019

::::::

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

WHO Region of the Americas PAHO
:: PAHO Director calls for private sector cooperation in COVID-19 response in the Americas (04/03/2020)
:: PAHO launches searchable database on COVID-19 guidance and research (04/02/2020)
:: PAHO appeals for $95 million to help Latin America and the Caribbean cope with the COVID-19 pandemic (04/02/2020)
:: Time is of the essence – Countries of the Americas must act now to slow the spread of COVID-19 (03/31/2020)

WHO South-East Asia Region SEARO
:: COVID19: WHO calls for stronger whole of society approach in South-East Asia Region
3 April 2020 News release Amidst rapid spread of COVID19 and continuing challenges, the World Health Organization today emphasized on a stronger whole of society and whole of government effort in South-East …

WHO European Region EURO
:: “China shows COVID-19 responses must be tailored to the local context” 03-04-2020
:: WHO project on cultural contexts of health and well-being adopted in the United States 03-04-2020
:: Supporting older people during the COVID-19 pandemic is everyone’s business 03-04-2020
:: WHO releases guidelines to help European countries maintain essential health services during the COVID 19 pandemic 02-04-2020
:: Health System Response Monitor: new tool to analyse COVID-19 response measures across European countries launched 02-04-2020

WHO Eastern Mediterranean Region EMRO
:: The fight to contain COVID-19 in Iraq 1 April 2020
:: Meeting the needs of the most vulnerable in Yemen 30 March 2020

WHO Western Pacific Region
:: Virtual press conference on COVID-19 in the Region 31 March 2020
Opening remarks of Dr Takeshi Kasai, WHO Regional Director for the Western Pacific

CDC/ACIP [to 28 Mar 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases
COVID-19-Related Phone Scams and Phishing Attacks
Friday, April 3, 2020
[Editor’s Note: No other COVID-19 announced identified on CDC site]

Africa CDC [to 28 Mar 2020]
http://www.africacdc.org/
News
No new digest content identified.

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

National Health Commission of the People’s Republic of China
http://en.nhc.gov.cn/
News
April 4: Daily briefing on novel coronavirus cases in China
2020-04-04
On April 3, 31 provincial-level regions on the Chinese mainland as well as the Xinjiang Production and Construction Corps reported 19 new cases of confirmed infections (18 imported cases and 1 indigenous case in Hubei province), 11 new cases of suspected infections (all are imported cases), and 4 deaths (all in Hubei). 180 patients were released from hospital after being cured. 2,346 people who had had close contact with infected patients were freed from medical observation. Serious cases decreased by 48…

Xi vows to aid developing nations’ fight
2020-04-04
China to help countries that have weak health systems prepare, respond to virus
China vowed on April 3 to help enhance the preparedness and response of developing countries with weak public health systems amid the COVID-19 pandemic that has infected more than a million people worldwide.
President Xi Jinping made the remark in two separate phone conversations, with his Namibian and Lao counterparts, part of his busy diplomatic schedule. He has made dozens of phone calls to world leaders since the pandemic’s outbreak.
While talking with President of Namibia Hage Geingob, Xi said China will continue to step up assistance, share experience and strengthen public health cooperation with Namibia and other African countries to secure the final victory against the virus.
China has overcome its own difficulties, provided epidemic prevention materials to the African Union and African countries and organized videoconferences for experts to share experience. Some Chinese companies and nongovernmental institutions have also offered a hand, Xi said.
All these are reflections of a China-Africa community with a shared future, he added…

Announcements
 
 
Paul G. Allen Frontiers Group    [to 28 Mar 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
Press Release
No new digest content identified.
 
 
BMGF – Gates Foundation  [to 28 Mar 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute    [to 28 Mar 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 28 Mar 2020]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
No new digest content identified.
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 28 Mar 2020]
http://cepi.net/
Latest News
Norway intensifies COVID-19 fight with NOK2.2 billion donation to CEPI
01 Apr 2020
 
 
Clinton Health Access Initiative, Inc. (CHAI)  [to 28 Mar 2020]
https://clintonhealthaccess.org/
News & Press Releases
No new digest content identified.
 
 EDCTP    [to 28 Mar 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
3 April 2020
Emergency funding of COVID-19 research among EDCTP 2020 calls for proposals
Today, EDCTP is publishing seven 2020 calls for proposals to support clinical research on poverty-related diseases, including neglected infectious diseases, and research capacity development in sub-Saharan Africa. The calls represent an investment of more than €80 million.

1 April 2020
Professor Gita Ramjee passed away on 31 March 2020
Yesterday, Professor Gita Ramjee, Chief Scientific Officer of the Aurum Institute in South Africa, passed away due to complications of a COVID-19 infection. Many in the EDCTP General Assembly, the Scientific Advisory Committee and the Secretariat worked with her and…
 
 
Emory Vaccine Center    [to 28 Mar 2020]
http://www.vaccines.emory.edu/
No new digest content identified.
 
 
European Medicines Agency  [to 28 Mar 2020]
http://www.ema.europa.eu/ema/
News & Press Releases ·
Press release: EMA provides recommendations on compassionate use of remdesivir for COVID-19
CHMP, Last updated: 03/04/2020

News: International regulators discuss available knowledge supporting COVID-19 medicine development
Last updated: 03/04/2020

News: COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes
Last updated: 01/04/2020

News: EU recommendations for 2020/2021 seasonal flu vaccine composition
CHMP, Last updated: 01/04/2020

Press release: Advancing regulatory science in the EU – new strategy adopted
Last updated: 31/03/2020

Press release: Update on treatments and vaccines against COVID-19 under development
Last updated: 31/03/2020
 
 
European Vaccine Initiative  [to 28 Mar 2020]
http://www.euvaccine.eu/news-events
Latest News
No new digest content identified.
 
 
FDA [to 28 Mar 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
April 3, 2020 – Coronavirus (COVID-19) Update: Daily Roundup April 3, 2020

…The FDA announced that it is leading an effort, working collaboratively with government, industry and academic partners, to develop and implement a protocol that will provide convalescent plasma to patients in need across the country who may not have access to institutions with clinical trials in place.  Convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by COVID-19. This collaboration, involving BARDA, the American Red CrossExternal Link Disclaimer and the Mayo ClinicExternal Link Disclaimer, will allow for a simplified process for health care providers that will help ensure patient safety while allowing for the collection of needed information about product efficacy. The FDA anticipates that the effort will be able to move thousands of units of plasma to patients who need them in the coming weeks… 

April 3, 2020 – Coronavirus (COVID-19) Update: FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19

April 2, 2020 – Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic
 
 
Fondation Merieux  [to 28 Mar 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.
 
 
Gavi [to 28 Mar 2020]
https://www.gavi.org/
Top Stories
COVID-19: massive impact on lower-income countries threatens more disease outbreaks
:: At least 13.5 million people to miss out on vaccinations due to postponement of campaigns and interruptions in routine vaccinations, with millions more likely to follow
:: Gavi, the Vaccine Alliance is urgently providing support for countries’ COVID-19 response and in addition is ready to support mass vaccination campaigns once lockdowns finish
:: Dr Seth Berkley: “The legacy of COVID-19 must not include the global resurgence of other killers like measles and polio.”
Geneva, 3 April 2020

Modelling suggests suppression strategy will save more lives from COVID-19 in poor countries
Imperial model of the spread of COVID-19 implies a suppression strategy could be most effective.
1 April 2020
 
 
GHIT Fund   [to 28 Mar 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 March 31, 2020
GHIT Fund Announces New Investments: A Total of 3.29 Billion Yen in Drugs for Malaria, Tuberculosis, Chagas Disease, Lymphatic Filariasis, and Onchocerciasis, Vaccines for Malaria, and Diagnostics for Leishmaniasis and Mycetoma

March 31, 2020
Statement: The Global Health Innovative Technology Fund and Unitaid collaboration to accelerate access to innovative solutions
 
 
Global Fund  [to 28 Mar 2020]
https://www.theglobalfund.org/en/news/
News & Stories
Funding Model
COVID-19 Response: Adaptations, Guidelines and Flexibilities for Countries
03 April 2020
 
 
Funding Model
COVID-19 Response: Continued Principal Recipient Reporting
02 April 2020

Funding Model
Funding Request Submission Dates Updated
31 March 2020

Sourcing & Management of Health Products
COVID-19 Impact on Supply Chain Logistics: Assessment and Recommendations
30 March 2020
 
 
Hilleman Laboratories   [to 28 Mar 2020]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 28 Mar 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.
 
 
IAVI  [to 28 Mar 2020]
https://www.iavi.org/newsroom
Press Releases
April 1, 2020
IAVI Welcomes W. Ripley Ballou, M.D., as ADVANCE Program Lead and Principal Investigator
NEW YORK – APRIL 1, 2020 – IAVI, a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, is pleased to announce the appointment of W. Ripley (“Rip”) Ballou, M.D., as ADVANCE Program Lead and Principal Investigator. This groundbreaking global initiative to accelerate the development of vaccines and new technologies to combat the AIDS epidemic in partnership with Africa is funded by the U.S. Agency for International Development (USAID) through the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR)…
 
 
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
IGBA urgent recommendations to keep medicine supply chains flowing
27 March 2020
[See Milestones above for detail]
 
 
IFFIm
http://www.iffim.org/
Press Releases
No new digest content identified.
 
 
IFRC   [to 28 Mar 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.
 
 
IVAC  [to 28 Mar 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
No new digest content identified.
 
 
IVI   [to 28 Mar 2020]
http://www.ivi.int/
Selected IVI News & Announcements
USask VIDO-InterVac and International Vaccine Institute collaborate on COVID-19 work
The International Vaccine Institute (IVI) of South Korea, a world-renowned international organization founded by the United Nations Development Programme, is collaborating with VIDO-InterVac at the University of Saskatchewan (USask) to better understand the virus causing the COVID-19 pandemic and to develop vaccines and potential treatments.
USask Research Profile and Impact
Mar 27, 2020
 
 
JEE Alliance  [to 28 Mar 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 28 Mar 2020]
http://www.msf.org/
Latest [Selected Announcements]
France
Ensuring medical care for vulnerable people in and around Paris as …
Project Update 3 Apr 2020

Nigeria
Borno state: In the face of the COVID-19 pandemic, other dise…
Project Update 3 Apr 2020

Belgium
COVID-19: MSF launches its largest ever response in Belg…
Project Update 3 Apr 2020

Syria
Northwest Syria: “COVID-19 adds another layer of com…
Project Update 2 Apr 2020

Italy
COVID-19 pandemic brings new challenges to well-developed hea…
Interview 31 Mar 2020

Coronavirus disease COVID-19
MSF steps up COVID-19 response in Europe
Press Release 30 Mar 2020
 
National Vaccine Program Office – U.S. HHS  [to 28 Mar 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC 2020 Meetings
June 9-10, 2020 NVAC Meeting
September 23-24, 2020 Meeting (Virtual)
 
 
NIH  [to 28 Mar 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
No new digest content identified.
 
 
PATH  [to 28 Mar 2020]
https://www.path.org/media-center/
Selected Announcements
PATH-led study finds commercially available reference diagnostic detects malaria with whole blood sample
April 1, 2020 by PATH
Commercially available diagnostic can effectively detect all malaria parasites, including cases with suspected gene mutations, with a whole blood sample.
 
 
Sabin Vaccine Institute  [to 28 Mar 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
Sabin Vaccine Institute Names David Salisbury, Jeffrey P. Libson to Board of Trustees, Philip K. Russell Retires to Advisory Role
Thursday, April 2, 2020
Past Chair & President Philip K. Russell Retires as Trustee, Assumes Advisory Role
WASHINGTON, D.C. – The Sabin Vaccine Institute (Sabin) today announced that Professor David Salisbury and Jeffrey P. Libson have been named to the Board of Trustees and Retired Major General Philip K. Russell will transition from Trustee to Special Advisor after more than 25 years of service to the organization.

Each with some 40 years of experience, Salisbury and Libson bring additional global immunization policy and legal expertise to Sabin’s board. Salisbury is a well-respected leader in immunization program policy, vaccine research and disease eradication and Libson is a corporate and transactional attorney to the life sciences community who has also provided legal expertise to a number of non-profit life science organizations…
 
 
UNAIDS [to 28 Mar 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
2 April 2020
People living with HIV in the Republic of Moldova to receive free home delivery of antiretroviral therapy

1 April 2020
A tribute to Gita Ramjee
 
 
UNICEF  [to 28 Mar 2020]
https://www.unicef.org/media/press-releases

Press release
WHO and UNICEF to partner on pandemic response through COVID-19 Solidarity Response Fund
Unprecedented fund an ‘all hands on deck’ approach to tackle COVID-19 pandemic
03/04/2020

Press release
IPA, WHO and UNICEF launch Read the World on International Children’s Book Day to support children and young people in isolation
Geronimo Stilton author to kickstart exclusive children’s book reading initiative amid COVID-19 pandemic
01/04/2020

Statement
COVID-19 pandemic could devastate refugee, migrant and internally displaced populations without urgent international action
Statement by UNICEF Executive Director Henrietta Fore
NEW YORK, 1 April 2020 – “COVID-19 will almost certainly gain a foothold in refugee camps, crowded reception centers or detention facilities holding migrant families. Given how quickly the virus is spreading, such a scenario is looking imminent.
“Even absent a pandemic, uprooted children and families – those living as refugees, migrants or internally displaced – face immense barriers to accessing healthcare and preventative services like proper handwashing and sanitation facilities. So, when an infectious disease hits, their risk is compounded.

“An outbreak of a respiratory disease like COVID-19 could spread easily through the overcrowded confines and unsafe conditions typical of many camps or settlements. Families in these environments would be more likely to get sick and less capable of fighting off the disease because of inadequate services.

“We are not talking about a small number of people either. Today, there are 31 million children who have been uprooted from their homes, including over 17 million internally displaced, 12.7 million refugees and 1.1 million asylum seekers. All of them need some form of assistance. Most of them do not have the luxury of calling a doctor when sick, of washing their hands whenever they need to, or of practicing physical distancing to stop disease transmission.

“Any public health response to the pandemic should reach the most vulnerable, including refugees, migrants and those who are internally displaced. This means ensuring equitable access to testing and treatment as well as access to prevention information and to water and sanitation services. There should be plans in place for safe, family-based care and support for children separated from their caregivers or whose caregivers die.

“It also means that containment measures, like border closures and movement restrictions, should not block children’s right to seek asylum and reunite with family members. Nor should it hinder aid agencies’ efforts to provide humanitarian aid. Uprooted children and families should be moved quickly out of harm’s way to adequate accommodations where they have access to water, soap, physical distancing and safety.

“UNICEF is working with partners to prevent the spread of the disease among refugee, migrant and displaced populations. This includes promoting hygiene practices that help prevent transmission in shelters, camps and other accommodation sites. It includes developing accurate, child friendly information on COVID-19 and materials to fight stigma and promote positive parenting. It also includes distributing hygiene supplies and providing access to water.

“But we cannot do this alone. Now, more than ever, governments and the international community should come together to protect the most vulnerable in these unprecedented times.”

Press release
Children in the Democratic Republic of the Congo at risk from killer measles, cholera epidemics
COVID-19 latest challenge facing battered health services
31/03/2020

Press release
UNICEF supplies arrive in Italy to support COVID-19 response
30/03/2020

Press release
Greater support needed for working families as COVID-19 takes hold – UNICEF and ILO
Newly released recommendations for businesses aim to help employers strengthen support for families during the pandemic
 
 
Unitaid  [to 28 Mar 2020]
https://unitaid.org/#en
Unitaid is a global development agency, hosted by the World Health Organization and its major donors are France, the United Kingdom, Brazil, Norway, Chile, the Republic of Korea, Spain and the Bill & Melinda Gates Foundation.

03 April 2020 | Statements

Medicines Patent Pool and Unitaid respond to access efforts for COVID-19 treatments and technologies

The Board of the Medicines Patent Pool (MPP) has decided to temporarily expand its mandate to include any health technology that could contribute to the global response to COVID-19 and where licensing could facilitate innovation and access. With the support of Unitaid, this will allow MPP to offer its intellectual property and licensing expertise to the World Health Organization (WHO) to assist the global effort in any way it can.

Both MPP and Unitaid underline their commitment to jointly ensure equitable and timely access to medicines and diagnostics by the most vulnerable populations, as stressed in the G20 Leaders’ 26 March 2020 Statement.

Marie-Paule Kieny, Chair of the MPP Governance Board, said, “In these difficult times, the MPP Board recognises the important role that MPP can play to increase access to life-saving products for those who need them most. And importantly, with time of the essence, to ensure that we make use of the expertise and mechanisms that already exist.”…
 
 
Vaccination Acceptance Research Network (VARN)  [to 28 Mar 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.
 
 
Vaccine Confidence Project  [to 28 Mar 2020]
http://www.vaccineconfidence.org/
Latest News & Archive
No new digest content identified.
 
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 28 Mar 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
Coronavirus Updates
Frequently Asked Questions about Coronavirus Disease 2019 (COVID-19)
Last Updated: March 19, 2020
Get some fast facts about the coronavirus from CHOP and the CDC. The CDC will provide updated information as it becomes available.
 
 
 
Wellcome Trust  [to 28 Mar 2020]
https://wellcome.ac.uk/news
News | 31 March 2020
Wellcome joins the UK government, industry and universities in a step-change to COVID-19 testing

Wellcome is supporting a step-change in COVID-19 testing by the UK government. This is a collaborative project, with partners including the NHS, Public Health England, diagnostics companies Thermo Fisher Scientific, QIAGEN and Randox, UK universities, Boots, Royal Mail and Amazon.
 
 
The Wistar Institute   [to 28 Mar 2020]
https://www.wistar.org/news/press-releases
Press Releases
Apr. 1, 2020

The Wistar Institute Signs Lease at 3.0 University Place

Signed lease agreement of up to 10 years for 8,000 sf with options for additional space to support long-term needs. In addition to their own Wistar Discovery Center lab space, Wistar will launch programming and curate lab partnerships​ ​in the new facility and throughout the life sciences sector.

3.0 University Place will provide 250,000 sf of lab and office space, specifically targeting biomedical research and advanced life science companies, with estimated delivery of Q3 2021…
 
 
WFPHA: World Federation of Public Health Associations  [to 28 Mar 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.
 
 
World Organisation for Animal Health (OIE)   [to 28 Mar 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.
 
 
ARM [Alliance for Regenerative Medicine]  [to 28 Mar 2020]
https://alliancerm.org/press-releases/
Press Releases
The Alliance for Regenerative Medicine to Host FDA Representatives for Webinar on Clinical Trial Guidance During COVID-19 on April 10, 2020
April 2, 2020
WASHINGTON, DC
 
 
BIO    [to 28 Mar 2020]
https://www.bio.org/press-releases
Press Releases
2020 BIO International Convention Now Fully Digital
April 3, 2020
The Biotechnology Innovation Organization (BIO) announced today it will be moving the 2020 BIO International Convention scheduled for June 8-11 in San Diego to an online platform, in lieu of an in-person event for this year. The decision was based…
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 28 Mar 2020]
http://www.dcvmn.org/
News
No new digest content identified.
 
 
IFPMA   [to 28 Mar 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA Backgrounder – COVID-19
03 April 2020
[See COVID-19 for detail]
 
 
PhRMA    [to 28 Mar 2020]
http://www.phrma.org/

Selected Press Releases, Statements

The biopharmaceutical industry’s unique role in responding to COVID-19

Richard Moscicki, M.D.  April 2, 2020

As the outbreak of COVID-19, a disease caused by a novel strain of coronavirus, evolves in the United States and around the globe, both the private and public sectors are working around the clock to find solutions. America’s biopharmaceutical companies are working tirelessly to develop ways to diagnose, prevent and treat those with coronavirus.

Here is a closer look at four key ways the biopharmaceutical industry is fighting COVID-19:

1. Developing Potential New Treatments and Vaccines

As part of its commitment to finding solutions for patients with COVID-19 and preventing others from becoming infected, PhRMA members have been donating investigational compounds that may have potential to treat coronavirus for emergency use and in clinical trials, including compounds formerly tested on other viral pathogens such as Ebola and HIV.

Companies are also deploying their own clinical trials as quickly as possible to test promising investigational antiviral agents.  Other members are researching novel and existing vaccine candidates to identify promising candidates that have the ability to protect people from coronavirus infection. Importantly, biopharmaceutical industry research and development programs are pursuing a wide diversity of approaches to the development of treatments and vaccines and are also seeking to reduce the most severe of related symptoms associated with COVID-19.

Multiple avenues to preventive measures include a variety of vaccine approaches including mRNA and DNA vaccines, vaccines using synthetic materials and therapeutic antibodies that could be used not only to treat COVID-19 but also as a temporary preventive treatment in the absence of a vaccine.

Treatments under investigation include antiviral approaches such as protease inhibitors and nucleotide analogs to slow or reduce viral infections and treatments to reduce the severity of pulmonary manifestations of COVID-19 such as IL-6 inhibitors to reduce the risk of “cytokine storm” and antibacterials and vaccines to reduce the risk of secondary pneumococcal pneumonia.  It is not just the number of shots on goal, but also the wide variety of approaches being taken, that optimizes the chances of finding successful disease treatment and prevention.

Companies are also leveraging existing technologies to provide the ability to rapidly upscale production once a potential vaccine candidate is identified. Many companies are already investing heavily to increase production capacity. Similar efforts are underway for small molecule and antibody treatments.

2. Engaging with Public Partners to share knowledge

Responding effectively to a public health emergency requires close collaboration between public and private organizations around the world to share insights that could accelerate treatment and prevention strategies. Leading PhRMA member companies are collaborating with relevant U.S. and global public health authorities, including the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO), as well as public health authorities in China and Europe, to understand how pandemic preparedness platforms can be tailored to address the current emergency, and how to accelerate the development of potential treatments. Members are also sharing the learnings from clinical trials in real time with governments and other companies to advance the development of additional therapies

3. Advancing Past Learnings

Up until the outbreak began, COVID-19, a disease caused by a novel strain of coronavirus, did not exist. The rapid pace at which researchers have been able to understand this strain and get medicines into human clinical trials is a testament to the lessons learned from past public health emergencies. Furthermore, the biopharmaceutical industry has the unparalleled advantage of decades of scientific research cultivated from experience with similar viruses, such as MERS, SARS and influenza. These previous public health emergencies have helped put the infrastructure and partnerships in place to enable a more rapid response to emerging threats.

4. Manufacturing Production

Innovative biopharmaceutical companies have the capacity to manufacture and broadly disseminate vaccines and treatments to patients worldwide. America’s biopharmaceutical companies are already ramping up production capacity in anticipation of the discovery of an effective treatment or vaccine. They are also protecting the integrity of the pharmaceutical supply chain and keeping plants open to maintain a steady supply of medicines for patients. All the while, our member companies are staying in constant communication with the U.S. Food and Drug Administration.

The biopharmaceutical industry is committed to developing solutions to address this global public health emergency just as it has in the past. PhRMA member companies not only bring decades of expertise in infectious diseases, including other strains of coronavirus, but bring the infrastructure and technologies to allow them to quickly advance potential vaccine and treatment candidates to clinical trials and have the manufacturing capabilities and expertise to allow for quick scale up.

Read more about the industry’s contributions to the COVID-19 pandemic and our principles here.

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
April 2020 Volume 48, Issue 4, p355-470
http://www.ajicjournal.org/current

Major Articles
Trend of influenza vaccine Facebook posts in last 4 years: a content analysis
Chintan K. Gandhi, Jayesh Patel, Xiang Zhan
p361–367
Published online: February 22, 2020

American Journal of Infection Control
April 2020 Volume 48, Issue 4, p355-470
http://www.ajicjournal.org/current

Compliance with immunization and a biological risk assessment of health care workers as part of an occupational health surveillance program: The experience of a university hospital in southern Italy
Francesco Paolo Bianchi, Luigi Vimercati, Francesca Mansi, Sara De Nitto, Pasquale Stefanizzi, Letizia Alessia Rizzo, Grazia Rita Fragnelli, Enza Sabrina Silvana Cannone, Luigi De Maria, Angela Maria Vittoria Larocca, Silvio Tafuri
p368–374
Published online: November 18, 2019

American Journal of Tropical Medicine and Hygiene
Volume 102, Issue 4, April 2020
http://www.ajtmh.org/content/journals/14761645/102/4

Editorial
Estimating Malaria Incidence through Modeling Is a Good Academic Exercise, but How Practical Is It in High-Burden Settings?
Yazoume Ye and Andrew Andrada
Pages: 701–702
https://doi.org/10.4269/ajtmh.20-0120

American Journal of Tropical Medicine and Hygiene
Volume 102, Issue 4, April 2020
http://www.ajtmh.org/content/journals/14761645/102/4

Meeting Report
Developing a Road Map to Spread Genomic Knowledge in Africa: 10th Conference of the African Society of Human Genetics, Cairo, Egypt
Ghada Y. El-Kamah, Amal M. Mohamed, Yehia Z. Gad, Sonia Abdelhak, Branwen J. Hennig, Raj S. Ramesar, Guida Landouré, Amadou Gaye, Melanie J. Newport, Scott M. Williams and Michèle Ramsay
Pages: 719–723
https://doi.org/10.4269/ajtmh.19-0408
The tenth conference of the African Society of Human Genetics was held in Egypt with the theme “Human Genetics and Genomics in Africa: Challenges for Both Rare and Common Genetic Disorders.” Current research was presented, and we discussed visions for the future of genomic research on the African continent. In this report, we summarize the presented scientific research within and relevant to Africa as presented by both African and non-African scientists. We also discuss the current situation concerning genomic medicine and genomic research within the continent, difficulties in implementing genetic services and genomic medicine in Africa, and a road map to overcome those difficulties and meet the needs of the African researchers and patients.

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 28 Mar 2020)

Effect of age at vaccination on the measles vaccine effectiveness and immunogenicity: systematic review and meta-analysis
The objectives of this review were to evaluate the effect of age at administration of the first dose of a measles-containing vaccine (MCV1) on protection against measles and on antibody response after one- and…
Authors: Sara Carazo, Marie-Noëlle Billard, Amélie Boutin and Gaston De Serres
Citation: BMC Infectious Diseases 2020 20:251
Content type: Research article
Published on: 29 March 2020

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 28 Mar 2020)

The fiscal value of human lives lost from coronavirus disease (COVID-19) in China
Authors: Joses M. Kirigia and Rose Nabi Deborah Karimi Muthuri
Citation: BMC Research Notes 2020 13:198
Content type: Research note
Published on: 1 April 2020
Abstract
Objective
According to the WHO coronavirus disease (COVID-19) situation report 35, as of 24th February 2020, there was a total of 77,262 confirmed COVID-19 cases in China. That included 2595 deaths. The specific objective of this study was to estimate the fiscal value of human lives lost due to COVID-19 in China as of 24th February 2020.
Results
The deaths from COVID-19 had a discounted (at 3%) total fiscal value of Int$ 924,346,795 in China. Out of which, 63.2% was borne by people aged 25–49 years, 27.8% by people aged 50–64 years, and 9.0% by people aged 65 years and above. The average fiscal value per death was Int$ 356,203. Re-estimation of the economic model alternately with 5% and 10 discount rates led to a reduction in the expected total fiscal value by 21.3% and 50.4%, respectively. Furthermore, the re-estimation of the economic model using the world’s highest average life expectancy of 87.1 years (which is that of Japanese females), instead of the national life expectancy of 76.4 years, increased the total fiscal value by Int$ 229,456,430 (24.8%).

Bulletin of the World Health Organization
Volume 98, Number 4, April 2020, 229-296
https://www.who.int/bulletin/volumes/98/4/en/

EDITORIALS
Balancing risks and benefits of artificial intelligence in the health sector
— Kenneth Goodman, Diana Zandi, Andreas Reis & Effy Vayena
http://dx.doi.org/10.2471/BLT.20.253823

Bulletin of the World Health Organization
Volume 98, Number 4, April 2020, 229-296
https://www.who.int/bulletin/volumes/98/4/en/

Towards a global strategy on digital health
— Bernardo Mariano
http://dx.doi.org/10.2471/BLT.20.253955

Bulletin of the World Health Organization
Volume 98, Number 4, April 2020, 229-296
https://www.who.int/bulletin/volumes/98/4/en/

How do we reimagine health in a digital age?
— Flavia Bustreo & Marcel Tanner
http://dx.doi.org/10.2471/BLT.19.235358

Bulletin of the World Health Organization
Volume 98, Number 4, April 2020, 229-296
https://www.who.int/bulletin/volumes/98/4/en/

POLICY & PRACTICE
Defining ethical standards for the application of digital tools to population health research
— Gabrielle Samuel & Gemma Derrick
http://dx.doi.org/10.2471/BLT.19.237370
There is growing interest in population health research, which uses methods based on artificial intelligence. Such research draws on a range of clinical and non-clinical data to make predictions about health risks, such as identifying epidemics and monitoring disease spread. Much of this research uses data from social media in the public domain or anonymous secondary health data and is therefore exempt from ethics committee scrutiny. While the ethical use and regulation of digital-based research has been discussed, little attention has been given to the ethics governance of such research in higher education institutions in the field of population health. Such governance is essential to how scholars make ethical decisions and provides assurance to the public that researchers are acting ethically. We propose a process of ethics governance for population health research in higher education institutions. The approach takes the form of review after the research has been completed, with particular focus on the role artificial intelligence algorithms play in augmenting decision-making. The first layer of review could be national, open-science repositories for open-source algorithms and affiliated data or information which are developed during research. The second layer would be a sector-specific validation of the research processes and algorithms by a committee of academics and stakeholders with a wide range of expertise across disciplines. The committee could be created as an off-shoot of an already functioning national oversight body or health technology assessment organization. We use case studies of good practice to explore how this process might operate.

Bulletin of the World Health Organization
Volume 98, Number 4, April 2020, 229-296
https://www.who.int/bulletin/volumes/98/4/en/

Artificial intelligence and the ongoing need for empathy, compassion and trust in healthcare
— Angeliki Kerasidou
http://dx.doi.org/10.2471/BLT.19.237198
Empathy, compassion and trust are fundamental values of a patient-centred, relational model of health care. In recent years, the quest for greater efficiency in health care, including economic efficiency, has often resulted in the side-lining of these values, making it difficult for health-care professionals to incorporate them in practice. Artificial intelligence is increasingly being used in health care. This technology promises greater efficiency and more free time for health-care professionals to focus on the human side of care, including fostering trust relationships and engaging with patients with empathy and compassion. This article considers the vision of efficient, empathetic and trustworthy health care put forward by the proponents of artificial intelligence. The paper suggests that artificial intelligence has the potential to fundamentally alter the way in which empathy, compassion and trust are currently regarded and practised in health care. Moving forward, it is important to re-evaluate whether and how these values could be incorporated and practised within a health-care system where artificial intelligence is increasingly used. Most importantly, society needs to re-examine what kind of health care it ought to promote.

Bulletin of the World Health Organization
Volume 98, Number 4, April 2020, 229-296
https://www.who.int/bulletin/volumes/98/4/en/

Artificial intelligence in health care: accountability and safety
— Ibrahim Habli, Tom Lawton & Zoe Porter
http://dx.doi.org/10.2471/BLT.19.237487
The prospect of patient harm caused by the decisions made by an artificial intelligence-based clinical tool is something to which current practices of accountability and safety worldwide have not yet adjusted. We focus on two aspects of clinical artificial intelligence used for decision-making: moral accountability for harm to patients; and safety assurance to protect patients against such harm. Artificial intelligence-based tools are challenging the standard clinical practices of assigning blame and assuring safety. Human clinicians and safety engineers have weaker control over the decisions reached by artificial intelligence systems and less knowledge and understanding of precisely how the artificial intelligence systems reach their decisions. We illustrate this analysis by applying it to an example of an artificial intelligence-based system developed for use in the treatment of sepsis. The paper ends with practical suggestions for ways forward to mitigate these concerns. We argue for a need to include artificial intelligence developers and systems safety engineers in our assessments of moral accountability for patient harm. Meanwhile, none of the actors in the model robustly fulfil the traditional conditions of moral accountability for the decisions of an artificial intelligence system. We should therefore update our conceptions of moral accountability in this context. We also need to move from a static to a dynamic model of assurance, accepting that considerations of safety are not fully resolvable during the design of the artificial intelligence system before the system has been deployed.

Bulletin of the World Health Organization
Volume 98, Number 4, April 2020, 229-296
https://www.who.int/bulletin/volumes/98/4/en/

How to achieve trustworthy artificial intelligence for health
— Kristine Bærøe, Ainar Miyata-Sturm & Edmund Henden
http://dx.doi.org/10.2471/BLT.19.237289
Artificial intelligence holds great promise in terms of beneficial, accurate and effective preventive and curative interventions. At the same time, there is also awareness of potential risks and harm that may be caused by unregulated developments of artificial intelligence. Guiding principles are being developed around the world to foster trustworthy development and application of artificial intelligence systems. These guidelines can support developers and governing authorities when making decisions about the use of artificial intelligence. The High-Level Expert Group on Artificial Intelligence set up by the European Commission launched the report Ethical guidelines for trustworthy artificial intelligence in 2019. The report aims to contribute to reflections and the discussion on the ethics of artificial intelligence technologies also beyond the countries of the European Union (EU). In this paper, we use the global health sector as a case and argue that the EU’s guidance leaves too much room for local, contextualized discretion for it to foster trustworthy artificial intelligence globally. We point to the urgency of shared globalized efforts to safeguard against the potential harms of artificial intelligence technologies in health care.

Bulletin of the World Health Organization
Volume 98, Number 4, April 2020, 229-296
https://www.who.int/bulletin/volumes/98/4/en/

Ensuring trustworthy use of artificial intelligence and big data analytics in health insurance
— Calvin W L Ho, Joseph Ali & Karel Caals
http://dx.doi.org/10.2471/BLT.19.234732
Technological advances in big data (large amounts of highly varied data from many different sources that may be processed rapidly), data sciences and artificial intelligence can improve health-system functions and promote personalized care and public good. However, these technologies will not replace the fundamental components of the health system, such as ethical leadership and governance, or avoid the need for a robust ethical and regulatory environment. In this paper, we discuss what a robust ethical and regulatory environment might look like for big data analytics in health insurance, and describe examples of safeguards and participatory mechanisms that should be established. First, a clear and effective data governance framework is critical. Legal standards need to be enacted and insurers should be encouraged and given incentives to adopt a human-centred approach in the design and use of big data analytics and artificial intelligence. Second, a clear and accountable process is necessary to explain what information can be used and how it can be used. Third, people whose data may be used should be empowered through their active involvement in determining how their personal data may be managed and governed. Fourth, insurers and governance bodies, including regulators and policy-makers, need to work together to ensure that the big data analytics based on artificial intelligence that are developed are transparent and accurate. Unless an enabling ethical environment is in place, the use of such analytics will likely contribute to the proliferation of unconnected data systems, worsen existing inequalities, and erode trustworthiness and trust.

Bulletin of the World Health Organization
Volume 98, Number 4, April 2020, 229-296
https://www.who.int/bulletin/volumes/98/4/en/

PERSPECTIVES
Safeguards for the use of artificial intelligence and machine learning in global health
— Amy K Paul & Merrick Schaefer
http://dx.doi.org/10.2471/BLT.19.237099

Bulletin of the World Health Organization
Volume 98, Number 4, April 2020, 229-296
https://www.who.int/bulletin/volumes/98/4/en/

Ethical implications of conversational agents in global public health
— David D Luxton
http://dx.doi.org/10.2471/BLT.19.237636

Bulletin of the World Health Organization
Volume 98, Number 4, April 2020, 229-296
https://www.who.int/bulletin/volumes/98/4/en/

Artificial intelligence, diagnostic imaging and neglected tropical diseases: ethical implications
— Alon Vaisman, Nina Linder, Johan Lundin, Ani Orchanian-Cheff, Jean T Coulibaly, Richard KD Ephraim & Isaac I Bogoch
http://dx.doi.org/10.2471/BLT.19.237560

Bulletin of the World Health Organization
Volume 98, Number 4, April 2020, 229-296
https://www.who.int/bulletin/volumes/98/4/en/

Four equity considerations for the use of artificial intelligence in public health
— Maxwell J Smith, Renata Axler, Sally Bean, Frank Rudzicz & James Shaw
http://dx.doi.org/10.2471/BLT.19.237503

Bulletin of the World Health Organization
Volume 98, Number 4, April 2020, 229-296
https://www.who.int/bulletin/volumes/98/4/en/

Ethical barriers to artificial intelligence in the national health service, United Kingdom of Great Britain and Northern Ireland
— Claire Louise Thompson & Heather May Morgan
http://dx.doi.org/10.2471/BLT.19.237230