Public Health
Volume 185 Pages A1-A2, 1-406 (August 2020)
https://www.sciencedirect.com/journal/public-health/vol/185/suppl/C
Review article Abstract only
The promise of big data for precision population health management in the US
A. Han, A. Isaacson, P. Muennig
Public Health Reports
Volume 135 Issue 5, September/October 2020
https://journals.sagepub.com/toc/phrg/135/5
Research
Trends in Childhood Influenza Vaccination Coverage, United States, 2012-2019
Tammy A. Santibanez, PhD, Anup Srivastav, PhD, Yusheng Zhai, MSPH, James A. Singleton, PhD
First Published August 12, 2020; pp. 640–649
Science
11 September 2020 Vol 369, Issue 6509
http://www.sciencemag.org/current.dtl
Special Issue Genetic Variation
Introduction to special issue
The custom transcriptome
Laura M. Zahn
The panorama of human phenotypes arises from a mix of common and rare genetic variants, some of which affect how genes are expressed and spliced throughout the body. More than a decade ago, scientists aiming to better understand the effects of genetic diversity in healthy individuals launched the Genotype-Tissue Expression (GTEx) Consortium. Here, Science unveils the third and final phase of the project, presenting the results from the analysis of the version 8 (v8) GTEx release.
The v8 data release includes an increased number of tissues and individuals, which allows for more accurate mapping of putatively causal variants and identifies cell type–specific differences in gene expression. The increased size of the study also provides the power to link genetic variation to gene expression, both proximally and distally in the genome, so that cis and trans effects as well as population- and sex-specific differences in gene expression can be detected.
The efforts of the GTEx Consortium have led to the development of numerous tools, including Watershed, and have provided a comprehensive resource for the scientific community. The GTEx project has established a foundation to elucidate how genetic variants affect gene regulation and quantitative traits in humans. Such studies of genetic variation and tissue specificity inform on properties of the genome—including noncoding elements and the telomeres found at chromosome ends—and help us understand how gene variants influence aging and disease. This work sets the stage for future exploration into the effects of the common and rare variants that underlie the gamut of humanity.
Science
11 September 2020 Vol 369, Issue 6509
http://www.sciencemag.org/current.dtl
Policy Forum
An ethical framework for global vaccine allocation
By Ezekiel J. Emanuel, Govind Persad, Adam Kern, Allen Buchanan, Cécile Fabre, Daniel Halliday, Joseph Heath, Lisa Herzog, R. J. Leland, Ephrem T. Lemango, Florencia Luna, Matthew S. McCoy, Ole F. Norheim, Trygve Ottersen, G. Owen Schaefer, Kok-Chor Tan, Christopher Heath Wellman, Jonathan Wolff, Henry S. Richardson
Science11 Sep 2020 : 1309-1312
The Fair Priority Model offers a practical way to fulfill pledges to distribute vaccines fairly and equitably
Summary
Once effective coronavirus disease 2019 (COVID-19) vaccines are developed, they will be scarce. This presents the question of how to distribute them fairly across countries. Vaccine allocation among countries raises complex and controversial issues involving public opinion, diplomacy, economics, public health, and other considerations. Nevertheless, many national leaders, international organizations, and vaccine producers recognize that one central factor in this decision-making is ethics (1, 2). Yet little progress has been made toward delineating what constitutes fair international distribution of vaccine. Many have endorsed “equitable distribution of COVID-19…vaccine” without describing a framework or recommendations (3, 4). Two substantive proposals for the international allocation of a COVID-19 vaccine have been advanced, but are seriously flawed. We offer a more ethically defensible and practical proposal for the fair distribution of COVID-19 vaccine: the Fair Priority Model.
Social Science & Medicine
Volume 260 September 2020
https://www.sciencedirect.com/journal/social-science-and-medicine/vol/260/suppl/C
Review article Abstract only
The ethics of AI in health care: A mapping review
Jessica Morley, Caio C.V. Machado, Christopher Burr, Josh Cowls, … Luciano Floridi
Article 113172
Abstract
This article presents a mapping review of the literature concerning the ethics of artificial intelligence (AI) in health care. The goal of this review is to summarise current debates and identify open questions for future research. Five literature databases were searched to support the following research question: how can the primary ethical risks presented by AI-health be categorised, and what issues must policymakers, regulators and developers consider in order to be ‘ethically mindful? A series of screening stages were carried out—for example, removing articles that focused on digital health in general (e.g. data sharing, data access, data privacy, surveillance/nudging, consent, ownership of health data, evidence of efficacy)—yielding a total of 156 papers that were included in the review.
We find that ethical issues can be (a) epistemic, related to misguided, inconclusive or inscrutable evidence; (b) normative, related to unfair outcomes and transformative effectives; or (c) related to traceability. We further find that these ethical issues arise at six levels of abstraction: individual, interpersonal, group, institutional, and societal or sectoral. Finally, we outline a number of considerations for policymakers and regulators, mapping these to existing literature, and categorising each as epistemic, normative or traceability-related and at the relevant level of abstraction. Our goal is to inform policymakers, regulators and developers of what they must consider if they are to enable health and care systems to capitalise on the dual advantage of ethical AI; maximising the opportunities to cut costs, improve care, and improve the efficiency of health and care systems, whilst proactively avoiding the potential harms. We argue that if action is not swiftly taken in this regard, a new ‘AI winter’ could occur due to chilling effects related to a loss of public trust in the benefits of AI for health care.
Social Science & Medicine
Volume 260 September 2020
https://www.sciencedirect.com/journal/social-science-and-medicine/vol/260/suppl/C
Research article Abstract only
The influence of local political trends on childhood vaccine completion in North Carolina
Cierra Buckman, Indran C. Liu, Lindsay Cortright, Dmitry Tumin, Salma Syed
Article 113187
Travel Medicine and Infectious Diseases
Volume 36 July–August 2020
https://www.sciencedirect.com/journal/travel-medicine-and-infectious-disease/vol/36/suppl/C
Editorial Full text access
Pausing superspreader events for COVID-19 mitigation: International Hajj pilgrimage cancellation
Ziad A. Memish, Yusuf Ahmed, Saleh A. Alqahtani, Shahul H. Ebrahim
Article 101817
Travel Medicine and Infectious Diseases
Volume 36 July–August 2020
https://www.sciencedirect.com/journal/travel-medicine-and-infectious-disease/vol/36/suppl/C
Research article Abstract only
Measles immunity gaps in an era of high vaccination coverage: A serology study from Taiwan
Yi-Chen Lee, Yi-Hsuan Lee, Chia-Wen Lu, Shao-Yi Cheng, … Kuo-Chin Huang
Article 101804
Tropical Medicine & International Health
Volume 25, Issue 9 Pages: i-iv, 1043-1165 September 2020
https://onlinelibrary.wiley.com/toc/13653156/current
Original Research Papers
Regional variations of childhood immunisations in Senegal: a multilevel analysis
Sébastien Cortaredona, Rokhaya Diop, Valérie Seror, Luis Sagaon‐Teyssier, Patrick Peretti‐Watel
Pages: 1122-1130
First Published: 28 June 2020
Vaccine
Volume 38, Issue 41 Pages 6347-6484 (22 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/41
Discussion Abstract only
Measles immunity in emergency medical providers
AlleaBelle Gongola, Rebecca Reif, Hanna Jensen, Mack Hutchison, … Kevin W. Sexton
Pages 6350-6351
Vaccine
Volume 38, Issue 41 Pages 6347-6484 (22 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/41
Short communication Abstract only
‘Closing the gap’: Evaluating the success of non-mandatory strategies for influenza vaccination of Victorian healthcare workers
N. Bennett, S. Crouch, A. Hoskins, M.J. Malloy, … L.J. Worth
Vaccine
Volume 38, Issue 41 Pages 6347-6484 (22 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/41
Review article Full text access
So much at stake: Ethical tradeoffs in accelerating SARSCoV-2 vaccine development
Christine Grady, Seema Shah, Franklin Miller, Marion Danis, … Annette Rid
Pages 6381-6387
Vaccine
Volume 38, Issue 41 Pages 6347-6484 (22 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/41
Review article Full text access
The effect of Bacillus Calmette–Guérin (BCG) vaccination in preventing severe infectious respiratory diseases other than TB: Implications for the COVID-19 pandemic
Kiddus Yitbarek, Gelila Abraham, Tsinuel Girma, Tizta Tilahun, Mirkuzie Woldie
Vaccine
Volume 38, Issue 41 Pages 6347-6484 (22 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/41
Research article Open access
Long-term effectiveness of pentavalent and monovalent rotavirus vaccines against hospitalization in Taiwan children
Yhu-Chering Huang, Fang-Tzy Wu, Yi-Chuan Huang, Ching-Chun Liu, … Chao A. Hsiung
Vaccine
Volume 38, Issue 41 Pages 6347-6484 (22 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/41
Research article Open access
Efficacy after 1 and 2 doses of CYD-TDV in dengue endemic areas by dengue serostatus
Gustavo H. Dayan, Edith Langevin, Remi Forrat, Betzana Zambrano, … Carlos A. DiazGranados
Vaccine
Volume 38, Issue 41 Pages 6347-6484 (22 September 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/41
Research article Open access
Immunogenicity of influenza vaccines administered to pregnant women in randomized clinical trials in Mali and South Africa
Avnika B. Amin, Marta C. Nunes, Milagritos D. Tapia, Shabir A. Madhi, … Saad B. Omer
Pages 6478-6483
Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 12 Sep 2020)
Open Access Article
Trends, Spatial Disparities, and Social Determinants of DTP3 Immunization Status in Indonesia 2004–2016
by Holipah Holipah , Asri Maharani , Sujarwoto Sujarwoto , Takuji Hinoura and Yoshiki Kuroda
Vaccines 2020, 8(3), 518; https://doi.org/10.3390/vaccines8030518 – 10 Sep 2020
Viewed by 162
Abstract
Although 91% of 12–23-month-old children in Indonesia received at least one immunization in 2013, only 76% completed DTP3 immunization. This percentage is below the UNICEF and WHO recommended standards. Thus, this study aims to investigate trends, spatial disparities, and social determinants related to
Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 12 Sep 2020)
Open Access Article
Healthcare Workers Training Courses on Vaccinations: A Flexible Format Easily Adaptable to Different Healthcare Settings
by Laura Serino , Massimo Maurici , Gian Loreto D’Alò , Fabiana Amadori , Elisa Terracciano , Laura Zaratti , Elisabetta Franco and Local Health Units Vaccination Group
Vaccines 2020, 8(3), 514; https://doi.org/10.3390/vaccines8030514 – 08 Sep 2020
Viewed by 144
Abstract
Since 2017, Italy has expanded the compulsory vaccination from 4 to 10 for those aged 0 to 16 years. Because of the great organizational effort required for the immunization services, minor attention was given to the vaccinations not included among the mandatory ones. This situation led to a real difficulty in harmonizing the vaccination procedures even inside a single region. In the Lazio region, the Laboratory of Vaccinology of the University of Rome Tor Vergata established a working group to create a new training model for healthcare professionals
Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 12 Sep 2020)
Open Access Article
Increasing Measles Seroprevalence in a Sample of Pediatric and Adolescent Population of Tuscany (Italy): A Vaccination Campaign Success
by Beatrice Zanella , Sara Boccalini , Benedetta Bonito , Marco Del Riccio , Emilia Tiscione , Paolo Bonanni , Working Group DHS , Working Group AOUMeyer , Working Group AUSLTC and Angela Bechini
Vaccines 2020, 8(3), 512; https://doi.org/10.3390/vaccines8030512 – 08 Sep 2020
Viewed by 168
Abstract
Background: Despite the National Plan for the Elimination of Measles and congenital Rubella (NPEMcR), in 2017, a measles outbreak occurred in Italy, due to sub-optimal vaccination coverage (<95%) for many years. Since that year, the anti-measles vaccination became compulsory in minors (0–16
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 12 Sep 2020
[No new, unique, relevant content]
BBC
http://www.bbc.co.uk/
Accessed 12 Sep 2020
[No new, unique, relevant content]
The Economist
http://www.economist.com/
Accessed 12 Sep 2020
International
Covid-19 and beyond
The world needs a better World Health Organisation
The WHO has done well against covid-19. But it needs more muscle and more money
Sep 12th 2020 edition
Forbes
http://www.forbes.com/
Accessed 12 Sep 2020
Breaking | 9 hours ago
AstraZeneca Coronavirus Vaccine Trials Back On In U.K. After Abrupt Halt
After an investigation, the vaccine candidate was deemed safe by regulars, the company said.
By Carlie Porterfield Forbes Staff
Foreign Affairs
http://www.foreignaffairs.com/
Accessed 12 Sep 2020
[No new, unique, relevant content]
Foreign Policy
http://foreignpolicy.com/
Accessed 12 Sep 2020
Exclusive
Trump Administration Orders U.S. Diplomats to Curtail Contact With WHO
While Trump burns bridges with the World Health Organization, U.S. officials strain to preserve American influence in an institution that is critical to global health challenges.
Colum Lynch, Robbie Gramer, Allison Meakem
September 9, 2020, 4:41 PM
The Guardian
http://www.guardiannews.com/
[No new, unique, relevant content]
New Yorker
http://www.newyorker.com/
Medical Dispatch
It Will Take More Than a Vaccine to Beat COVID-19
Vaccines are making progress, but they may not defeat the virus completely. Luckily, other therapies are on the way, too.
By Dhruv Khullar
September 8, 2020
New York Times
http://www.nytimes.com/
Accessed 12 Sep 2020
Health
AstraZeneca Partly Resumes Coronavirus Vaccine Trial After Halting It for Safety
The company said tests of its vaccine would start up again in Britain while remaining suspended in the U.S. and other countries. Pfizer, a competitor, announced an expansion of its trials.
By Carl Zimmer, Katie Thomas and Benjamin Mueller
Sep 12
Politics
Trump Pressed for Plasma Therapy. Officials Worry, Is an Unvetted Vaccine Next?
New details of how the president has demanded faster action from health agencies help explain the intensifying concern that he could demand pre-Election Day approval of a vaccine.
By Sharon LaFraniere, Noah Weiland and Michael D. Shear
Sep 12
Canada
The Vaccine Challenge: ‘Not Putting All Our Eggs in One Basket’
Anita Anand is out shopping for millions of doses of a coronavirus vaccine that isn’t yet approved to make sure Canada is ready when it finally is.
By Ian Austen
Sept. 11
Business
How China is using promises of a vaccine as a diplomatic carrot.
With pledges of a coronavirus vaccine, China is on a charm offensive to repair strained diplomatic ties and bolster engagement with other countries.
By Sui-Lee Wee
Washington Post
https://www.washingtonpost.com/
Accessed 12 Sep 2020
National
Most Americans worry coronavirus vaccine will be rushed by political pressure, new poll finds
…Confidence in a coronavirus vaccine that the Trump administration said could be ready before Election…
Teo Armus, Jennifer Hassan, Marisa Iati, Paulina Villegas, Miriam Berger, Hamza Shaban, Meryl Kornfield, Paulina Firozi and Darren Sands · Sep 10, 2020
Think Tanks et al
Brookings
http://www.brookings.edu/
Accessed 12 Sep 2020
[No new relevant content]
Center for Global Development [to 12 Sep 2020]
http://www.cgdev.org/page/press-center
Accessed 12 Sep 2020
[No new relevant content]
Chatham House [to 12 Sep 2020]
https://www.chathamhouse.org/
[No new relevant content]
CSIS
https://www.csis.org/
Accessed 12 Sep 2020
Podcast Episode
Coronavirus Crisis Update: Heidi Larson – Time to Reset our Thinking on Vaccines
September 10, 2020 | By J. Stephen Morrison
We gather to discuss with Dr. Heidi Larson about her new book, Stuck: How Vaccine Rumors Start – and Why they Don’t Go Away, a wake-up call and appeal to re-think what drives popular distrust in science and rising levels of vaccine refusal and hesitancy. As the world strives to develop safe and effective vaccines…
Transcript
Online Event: The Scramble for a Vaccine: Putin’s Sputnik V— “Trust me!”
September 10, 2020
Council on Foreign Relations
http://www.cfr.org/
Accessed 12 Sep 2020
September 10, 2020
China
How China Ramped Up Disinformation Efforts During the Pandemic
Beijing has increased its manipulation of information as well as disinformation efforts around COVID-19 to damage democracies and boost itself, but its strategies have had mixed results.
In Brief by Joshua Kurlantzick
Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 12 Sep 2020
September 10, 2020 News Release
Poll: Most Americans Worry Political Pressure Will Lead to Premature Approval of a COVID-19 Vaccine; Half Say They Would Not Get a Free Vaccine Approved Before Election Day
Republican and Independent Voters See the Economy as Their Top Issue; Coronavirus and Race Relations Top Democrats’ List Most Americans (62%) worry that the political pressure from the Trump administration will lead the Food and Drug Administration to rush to approve a coronavirus vaccine without making sure that it is…
Vaccines and Global Health: The Week in Review is a weekly digest summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date
.– Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.
– pdf version: A pdf of the current issue is available here:
– blog edition: comprised of the approx. 35+ entries posted below.
– Twitter: Readers can also follow developments on twitter: @vaxethicspolicy.
.
– Links: We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
Support this knowledge-sharing service: Your financial support helps us cover our costs and to address a current shortfall in our annual operating budget. Click here to donate and thank you in advance for your contribution.
.
David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
Milestones :: Perspectives :: Research
COVID-19 Vaccines – Development Status/Scorecard
321 vaccine candidates against COVID-19 now in development
04 Sep 2020 By CEPI
In April, CEPI researchers identified 115 vaccine candidates against COVID-19 that were at varying stages of development. In an update to this analysis, we report in Nature Reviews Drug Discovery that, in the space of 5 months, this number has nearly tripled to 321 vaccine candidates. 32 of which are now in clinical trials, including eight candidates backed by CEPI.
Global progress in clinical trials and manufacturing
Progress towards a vaccine against COVID-19 has been truly global. Of the 32 candidates that are in clinical trials, there are plans to enroll 280,000 trial participants from at least 470 sites in 34 different countries.
Six clinical candidates are now in the most advanced phase III trials. These include two CEPI-supported candidates (AstraZeneca/Oxford and Moderna) and candidates that are being developed by Gamaleya Research Institute, Wuhan Institute of Biological Products/Sinopharm, Sinovac Biotech, and Pfizer/BioNTech.
For the leading candidates, large-scale manufacturing of vaccines has already been initiated to enable rapid distribution if approval is obtained. For CEPI’s part, it has established manufacturing agreements with AstraZeneca/Oxford, The University of Queensland/CSL, Clover Biopharmaceuticals, Novavax and SK Bioscience.
Technology platforms and vaccine targets
A wide range of technology platforms are being used to develop COVID-19 vaccines, including both traditional and novel approaches.
Early data are emerging for the most advanced clinical candidates and although encouraging antibody and T-cell responses have been reported, it is too early to assess their relative potential…
Milestones :: Perspectives :: Research
COVID-19 Vaccines & Therapeutics – Industry Standards/Commitments
Biopharma industry updates on COVID-19 treatments progress and warns about upholding regulatory standards of quality – IFPMA
Geneva, 3 September 2020 – Seven months into the pandemic, the innovative biopharmaceutical industry continues to step up work on researching and testing therapeutics that could lower mortality rates or lessen the severity of COVID-19. Over recent months, the results of rigorous clinical trials of repurposed medicines to achieve quick wins have been mixed, while the pipeline for new treatments does hold promise. Considerable efforts are going into planning to scale up and share manufacturing capacity should treatments prove safe and effective.
IFPMA is strongly committed to rigorous regulatory standards for approval of COVID-19 treatments and vaccines. No matter how urgently action is needed against the coronavirus public health emergency, it is imperative that the highest standards of quality, safety and efficacy are upheld everywhere. IFPMA member companies are fully committed to transparency in reporting clinical trial results whether these are good or bad; they support the need to inform the public of what they know, as well as what they don’t know about the vaccines in development.
The innovative biopharmaceutical industry believes that ensuring the right level of engagement with society whilst assessing and approving vaccines will be key to gaining the public’s trust in COVID-19 vaccines and helping end the coronavirus pandemic.
Vaccines may ultimately bring an end to the pandemic, but there is an urgent need for therapeutic innovation that can offer clinical benefits to COVID-19 patients. Today, more than 300 COVID-19 treatments are being researched or are in clinical trials around the world: some repurposed medicines proven to work against other deadly diseases, others as novel as the virus itself.
Today, 22 leading IFPMA member companies are involved in R&D for therapeutics and together have enacted or are conducting 81 clinical trials evaluating therapeutics’ effectiveness. The main COVID-19 treatments being looked at are antivirals, antibodies and convalescent plasma, as well as anti-inflammatories. This is encouraging as the clinical response to help patients with COVID-19 requires multiple treatment options but there is no magic bullet to treat or cure patients with the virus.
For some repurposed treatments, hopes have been dashed. Rigorous clinical trials have shown that hydroxychloroquine for patients with mild COVID-19 does not work. Tocilizumab has also proven to show no marked improvement in adult patients with severe COVID-19-associated pneumonia. In contrast, dexamethasone has proven effective in seriously ill COVID-19 patients. Researchers are now waiting for results of repurposed treatments used in combination.
Elsewhere, hopes have been fulfilled: remdesivir has gone in a matter of months from an investigational compound to an available therapy that shortens recovery times among hospitalized patients. Further down the line, other novel treatments may help patients with weakened immune systems. Progress is being made, but at a slower pace than society would have hoped for. Should a treatment prove safe or effective, biopharmaceutical companies are already planning upfront how to scale up and be ready to share manufacturing capacity in order to meet potential demand…
Thomas Cueni, Director General of IFPMA, commented on progress in finding treatments for COVID-19: “We’re still on a learning curve. However, we remain on course with single-minded focus and a willingness to take on the risks inherent in all innovation while pulling together our R&D capabilities for the benefit of patients living up to our commitments. What we’ve learnt so far is that there will unlikely be a magic bullet for everyone against COVID-19, but that is no excuse for cutting corners in our haste to approve new treatments or vaccines.”
::::::
BIO [to 5 Sep 2020]
https://www.bio.org/press-releases
Press Releases
Biotech Leaders Outline Principles to Ensure the “Public’s Trust” in New Medical Products for Eradicating Covid-19
September 3, 2020
As America’s researchers race to develop the scientific solutions needed to eradicate Covid-19, leaders within the Biotechnology Innovation Organization (BIO) released an open letter to their biopharmaceutical colleagues that articulates key principles to ensure the “integrity, transparency, and objective assessment” of Covid-19 clinical data and secure public trust in new medical products developed in response to the pandemic:
AN OPEN LETTER TO THE BIOPHARMACEUTICAL INDUSTRY
September 03, 2020
The biopharmaceutical industry is at the center of the world’s fight against Covid-19, leading the effort to develop new vaccines, therapeutic medicines and diagnostics.
Over time, we expect these efforts to be successful, resulting in a range of new healthcare products for the benefit of the entire world. These new products will need to be manufactured in large quantities and distributed rapidly to all segments of our society. Physicians, public health officials, patients and healthy citizens will need to be educated as to their safety, efficacy, and risk/ benefit. Their widespread adoption will be based on trust in the integrity of the scientific and public health principles governing their development and approval.
If this is done correctly, we will halt the pandemic, save lives, reignite our economy and enable a return to a more normal life. We will emerge from this pandemic better prepared to address and react to future biological threats.
As data begin to emerge from clinical trials of an array of vaccines and therapeutics, we believe that it is important for us in the biopharmaceutical industry to articulate the principles we see as essential for assessing these data and determining their potential value. We believe that public health, and the public’s trust in new medical products, are dependent upon the integrity, transparency and objective assessment of new data as they emerge.
Accordingly, we are articulating the following principles:
[1] Clinical trials should be conducted according to best practices to assure credibility of the data, as well as the ethical participation of a diverse population of subjects.
[2] Companies should disclose important clinical data via well-respected scientific meetings or rigorous, independent peer review journals. The disclosure of key scientific and clinical data through meetings and journals is the gold standard. However, companies may need to release some clinical data in advance of publication. In these instances, companies should approach any pre-publication press activity thoughtfully, and data should not be released by press release alone. Sponsors should ensure that data included in any press statement are clear and include accurate descriptions of key data points while reinforcing that the full data will be submitted for peer review.
[3] FDA should maintain its historic independence as the gold-standard international regulatory body, free from external influence. This will assure the public that the FDA review process will adhere to the highest standards of scientific and medical integrity, and that any approved products therefore will meet the required standards of safety and efficacy.
[4] The appropriate use of any new products should be data-driven. Different sub-populations are likely to react differently to different medicines. These differences will begin to be revealed in larger long-term studies. The public should be assured that only rigorously considered data will dictate the subsequent use of any product. Distribution of any vaccines should be done with these considerations in mind.
[5] Political considerations should be put aside by Republicans and Democrats alike. Our nation’s leaders should reassure the public that politics will not influence the development and approval of new medicines. Conclusions about both the safety and effectiveness of such medicines should be based on rigorous collection and assessment of data by all the appropriate bodies, and their distribution should be based on sound public health considerations. This approach is all the more vital considering the unprecedented pace and scale of the effort to develop treatments and vaccines for Covid-19.
We urge all parties involved in the development, review, approval, and distribution of COVID-19 therapeutics and vaccines to commit themselves to these principles.
Sincerely,
Jeremy M. Levin, DPhil, MB BChir
Chairman of the Board and CEO Ovid Therapeutics
Chair, Biotechnology Innovation Organization (BIO)
Paul J. Hastings
President and CEO Nkarta Therapeutics, Inc.
Vice Chair, Biotechnology Innovation Organization (BIO)
Ted W. Love, MD
President and CEO Global Blood Therapeutics
Chair, Emerging Companies Section Governing Board
Biotechnology Innovation Organization (BIO)
Michelle McMurry-Heath, MD, PhD
President and CEO
Biotechnology Innovation Organization (BIO)
Ron Cohen, MD
President and CEO Acorda Therapeutics, Inc.
Past Chair, Biotechnology Innovation Organization (BIO)
Rachel K. King
Founder and CEO GlycoMimetics, Inc.
Past Chair, Biotechnology Innovation Organization (BIO)
John Maraganore, PhD
CEO Alnylam Pharmaceuticals, Inc.
Past Chair, Biotechnology Innovation Organization (BIO)
Richard Pops
Chairman & CEO Alkermes, Inc.
Past Chair, Biotechnology Innovation Organization (BIO)
Milestones :: Perspectives :: Research
Featured Media Content
The Tragedy of Vaccine Nationalism
Only Cooperation Can End the Pandemic
Foreign Affairs September/October 2020
By Thomas J. Bollyky and Chad P. Bown
[Open Access]
Trump administration officials have compared the global allocation of vaccines against the coronavirus that causes COVID-19 to oxygen masks dropping inside a depressurizing airplane. “You put on your own first, and then we want to help others as quickly as possible,” Peter Marks, a senior official at the U.S. Food and Drug Administration who oversaw the initial phases of vaccine development for the U.S. government, said during a panel discussion in June. The major difference, of course, is that airplane oxygen masks do not drop only in first class—which is the equivalent of what will happen when vaccines eventually become available if governments delay providing access to them to people in other countries…
…THE POWER OF FOMO
When the oxygen masks drop in a depressurizing plane, they drop at the same time in every part of the plane because time is of the essence and because that is the best way to ensure the safety of all onboard. The same is true of the global, equitable allocation of safe and effective vaccines against COVID-19.
Vaccine nationalism is not just morally and ethically reprehensible: it is contrary to every country’s economic, strategic, and health interests. If rich, powerful countries choose that path, there will be no winners—ultimately, every country will be a loser. The world is not doomed to learn this the hard way, however. All the necessary tools exist to forge an agreement that would encourage cooperation and limit the appeal of shortsighted “my country first” approaches.
But time is running out: the closer the world gets to the day when the first proven vaccines emerge, the less time there is to set up an equitable, enforceable system for allocating them. As a first step, a coalition of political leaders from countries representing at least 50 percent of global vaccine-manufacturing capacity must get together and instruct their public health officials and trade ministers to get out of their silos and work together. Combining forces, they should hammer out a short-term agreement that articulates the conditions for sharing, including with the legions of poorer, nonmanufacturing countries, and makes clear what would happen to participants who subsequently reneged and undertook vaccine nationalism. Such a step would get the ball rolling and convince even more of the manufacturing countries to sign on. The fear of missing out on vaccine access, in the event their countries’ own vaccine candidates fail, may be what it takes to pressure even today’s most reluctant leaders to cooperate.
Milestones :: Perspectives :: Research
COVID-19 Vaccines – Africa
African countries engaging in ground-breaking COVID-19 vaccine initiative
03 September 2020
Brazzaville – While the race to find safe and effective COVID-19 vaccines continues, African countries are signing up to a ground-breaking initiative, which aims to secure at least 220 million doses of the vaccine for the continent, once licensed and approved.
All 54 countries on the continent have expressed interest in COVAX, a global initiative which is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance (Gavi) and the World Health Organization (WHO). The partners are working with governments and manufacturers to procure enough vaccine doses to protect the most vulnerable populations on the continent. Through the Gavi-coordinated COVAX Facility, the initiative seeks to ensure access for all: both higher and middle-income countries which will self-finance their own participation, and lower-middle income and low-income countries which will have their participation supported by the COVAX Advance Market Commitment (AMC).
There are eight countries in Africa that have agreed to self-finance their vaccine doses through the COVAX Facility. This expression of interest will turn into binding commitments to join the initiative by 18 September, with upfront payments to follow no later than 9 October 2020…
In addition, 46 countries in Africa are eligible for support from the financing instrument, the COVAX AMC which has raised approximately US$ 700 million against an initial target of securing US$ 2 billion seed funding from high-income donor countries, as well as private sector and philanthropists by the end of 2020.
“COVAX is a ground-breaking global initiative which will include African countries and ensure they are not left at the back of the queue for COVID-19 vaccines,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “By reaching beyond the continent to work together with other governments and manufacturers on a global scale and pooling buying power, countries can protect the people most vulnerable to the disease in Africa.”…
“It’s critical that countries in Africa participate in vaccine trials, in addition to the clinical trials taking place in other regions of the world,” said Dr Richard Hatchett, Chief Executive Officer, CEPI. “Testing vaccines on the continent ensures that sufficient data is generated on the safety and efficacy of the most promising vaccine candidates for the African population so they can be confidently rolled out in Africa once vaccines are approved. CEPI is investing in the research and development of a diverse range of vaccine candidates, with the aim of delivering safe and effective vaccines to those who need them most through COVAX.”
Through COVAX, vaccines that have passed regulatory approval or WHO prequalification will be delivered equally to all participating countries, proportional to their populations. Health workers and other vulnerable populations will be prioritized and then vaccine availability will expand to cover additional priority populations in participating countries.
African countries will need to have in place the right systems and infrastructure to define the regulatory and ethical pathways for a quick approval of a candidate vaccine. They will need to have logistics and supply chain systems which can reach not only the traditional target populations for routine immunizations and campaigns but be ready to vaccinate a much larger target population.
“To roll out a vaccine effectively across countries in Africa, it is critical that communities are engaged and understand the need for vaccination,” said Dr Richard Mihigo, Programme Area Manager, Immunization and Vaccine Development, Programme Area Manager, Immunization and Vaccine Development, WHO Regional Office for Africa. “It is important to already start working with communities to prepare the way for one of the largest vaccination campaigns Africa has ever experienced.”…
Milestones :: Perspectives :: Research
COVID-19 – Health Services Impacts
In WHO global pulse survey, 90% of countries report disruptions to essential health services since COVID-19 pandemic
WHO to roll out learning and monitoring tools to improve service provision during pandemic
31 August 2020 News release
The World Health Organization (WHO) today published a first indicative survey on the impact of COVID-19 on health systems based on 105 countries’ reports. Data collected from five regions over the period from March to June 2020 illustrate that almost every country (90%) experienced disruption to its health services, with low- and middle-income countries reporting the greatest difficulties. Most countries reported that many routine and elective services have been suspended, while critical care – such as cancer screening and treatment and HIV therapy – has seen high-risk interruptions in low-income countries.
“The survey shines a light on the cracks in our health systems, but it also serves to inform new strategies to improve healthcare provision during the pandemic and beyond,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “COVID-19 should be a lesson to all countries that health is not an ‘either-or’ equation. We must better prepare for emergencies but also keep investing in health systems that fully respond to people’s needs throughout the life course.”
Services hit across the board: Based on reports from key informants, countries on average experienced disruptions in 50% of a set of 25 tracer services. The most frequently disrupted areas reported included routine immunization – outreach services (70%) and facility-based services (61%), non-communicable diseases diagnosis and treatment (69%), family planning and contraception (68%), treatment for mental health disorders (61%), cancer diagnosis and treatment (55%).
Countries also reported disruptions in malaria diagnosis and treatment (46%), tuberculosis case detection and treatment (42%) and antiretroviral treatment (32%). While some areas of health care, such as dental care and rehabilitation, may have been deliberately suspended in line with government protocols, the disruption of many of the other services is expected to have harmful effects on population health in the short- medium- and long-term.
Potentially life-saving emergency services were disrupted in almost a quarter of responding countries. Disruptions to 24-hour emergency room services for example were affected in 22% of countries, urgent blood transfusions were disrupted in 23% of countries, emergency surgery was affected in 19% of the countries.
Disruption due to a mix of supply and demand side factors. 76% of countries reported reductions in outpatient care attendance due to lower demand and other factors such as lockdowns and financial difficulties. The most commonly reported factor on the supply side was cancellation of elective services (66%). Other factors reported by countries included staff redeployment to provide COVID-19 relief, unavailability of services due to closings, and interruptions in the supply of medical equipment and health products…
EMERGENCIES
Coronavirus [COVID-19]
Public Health Emergency of International Concern (PHEIC)
Weekly Epidemiological and Operational updates August 2020
Confirmed cases :: 26 468 031 [week ago: 24 587 513]
Confirmed deaths :: 871 166 [week ago: 833 556]
Weekly Epidemiological Update
Coronavirus disease 2019 (COVID-19)
4 September 2020
WHO response in countries
3 September 2020
A live digital Platform behind the scenes for more effective and transparent country response
2 September 2020
WHO updates clinical care guidance with corticosteroid recommendations
31 August 2020
Athens protects vulnerable communities during COVID-19
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Emergencies
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 03 September 2020
:: The Polio Oversight Board (POB) released a statement [see below] after holding a meeting on 18 August 2020 where they reviewed progress on resumption of vaccination campaigns after the Covid-19 induced pause, programme transformation in Pakistan, the increase in circulating Vaccine Derived Polio Virus (cVDPV) outbreaks, and the financial situation.
:: Professor Rose Leke, an infectious disease specialist, has been the chairperson of the ARCC since it was set up in 1998. A trailblazer for women in global health, Leke has fought throughout her career to improve women’s representation in science and global health leadership. Take a look at her journey in polio eradication and her views on gender and women in science.
Summary of new WPV and cVDPV viruses this week (AFP cases and environmental samples):
:: Afghanistan: Three WPV1 cases, one WPV1 positive environmental sample and 13 cVDPV2 cases
:: Pakistan: Five WPV1 positive environmental samples and three cVDPV2 positive environmental samples
:: Cameroon: one cVDPV2 positive environmental sample
:: Chad: three cVDPV2 cases
:: Democratic Republic of the Congo (DR Congo): one cVDPV2 case
::::::
Statement: POLIO OVERSIGHT BOARD – 24 August 2020
Meeting of 18 August 2020
On August 18, the Polio Oversight Board (POB) of the Global Polio Eradication Initiative (GPEI) convened to assess the status of polio eradication. The Board reviewed progress on resumption of vaccination campaigns after the Covid-19 induced pause, programme transformation in Pakistan, the increase in circulating Vaccine Derived Polio Virus (cVDPV) outbreaks, and the financial situation. The discussion was informed by the recent reports of the Independent Monitoring Board, the Pakistan and Afghanistan Technical Advisory Groups and the participation of major donors.
The COVID-19 pandemic impacted the polio eradication programme with paused campaigns, disruption of essential immunization and a decline in surveillance quality. The Board was humbled by the commitment of front-line polio staff to respond to the COVID-19 pandemic and who also recognized the importance of safely restarting campaigns to deliver polio accines in communities while the COVID virus circulates.
The pandemic demonstrates the critical role of GPEI funded staff for global health security and underlined the importance of integrating functions into the broader immunization and emergencies infrastructure to ensure the critical public health workforce remains a global asset even after the world has eradicated polio.
Agility, innovation and discipline, driven by a focus on activities on the critical path to polio eradication, are needed to offset the impact of the COVID-19 pandemic. GPEI will re-establish high-quality surveillance, intensify access negotiations in Afghanistan, accelerate the transformation of the Pakistan programme, and facilitate the resumption of immunization campaigns emphasizing the delivery of additional interventions when and where possible.
In view of the dynamic challenges faced, the POB approved a process to revise the 2019-2023 Polio Eradication Strategy and related budget, including the establishment of an external advisory group to advise on its content. To ensure that GPEI is best positioned to implement the revised strategy, the Board requested quick action on the Governance Review and complementary management review.
The Board reviewed with great concern the financial status of the Polio programme. Appreciating the generous pledges of support announced in Abu Dhabi in November 2019,
programmatic developments have put acute pressure on available resources. These developments include the setbacks in interrupting wild poliovirus in the two remaining polio endemic countries, a marked increase of cVDPV outbreaks, additional costs of infection prevention in the context of COVID-19 and the need to catch up on paused campaigns. This is compounded by economic impacts of the pandemic globally, which constrain financial resources and political attention in both programme and donor countries, leading to an anticipated substantial shortfall between resources required and resources available in 2021.
The Polio Oversight Board reviewed a plan to optimize the use of available and projected resources in 2021 and agreed that efficiencies can be realized. Board members also expressed concern that the level of risk associated with some of the proposed programmatic reductions could jeopardize both the gains and investments of the last 30 years and impede success. As an immediate step, GPEI will implement low risk-high return efficiency savings and strive to integrate efforts with other health interventions. The Board committed to advocating to increase national ownership and commitment, to raise the additional resources needed to meet urgent programme requirements and to intensify the response to the extraordinary challenges that have arisen, including exploring the use of COVID-19 resources where appropriate.
The POB reaffirmed the unequivocal commitment of GPEI partners to achieving global polio eradication.
The Board thanks all stakeholders for their commitment and support that has brought polio so close to eradication. We urge all partners and countries to continue to invest both human and financial resources in polio eradication and essential immunization so that no child needs suffer paralysis from this preventable disease.
::::::
::::::
Emergencies
Ebola – DRC+
Public Health Emergency of International Concern (PHEIC)
Last WHO Situation Report published 23 June 2020
::::::
::::::
WHO Grade 3 Emergencies [to 5 Sep 2020]
Democratic Republic of the Congo – No new digest announcements identified
Mozambique floods – No new digest announcements identified
Nigeria – No new digest announcements identified
Somalia – No new digest announcements identified
South Sudan – No new digest announcements identified
Syrian Arab Republic – No new digest announcements identified
Yemen – No new digest announcements identified
::::::
WHO Grade 2 Emergencies [to 5 Sep 2020]
Measles in Europe
:: Unleashing the potential of vaccines for a healthier Europe 02-09-2020
Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burkina Faso [in French] – No new digest announcements identified
Burundi – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Ethiopia – No new digest announcements identified
Iran floods 2019 – No new digest announcements identified
Iraq – No new digest announcements identified
Libya – No new digest announcements identified
Malawi – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Myanmar – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified
::::::
WHO Grade 1 Emergencies [to 5 Sep 2020]
Chad – No new digest announcements identified
Djibouti – Page not responding at inquiry
Kenya – No new digest announcements identified
Mali – No new digest announcements identified
Namibia – viral hepatitis – No new digest announcements identified
Tanzania – No new digest announcements identified
::::::
::::::
UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises.
Syrian Arab Republic
:: Syrian Arab Republic: COVID-19 Humanitarian Update No. 17 As of 1 September 2020
Yemen
:: 03 September 2020 Yemen Situation Report, 3 Sep 2020
– Torrential rains cause devastation across Yemen for the third time this year
– COVID-19 response to be pivoted
– Fuel crisis seriously holds back the humanitarian response in northern governorates
– Stranded migrants in Yemen in desperate need of humanitarian assistance
– Locust infestations threaten to exacerbate food insecurity in Yemen
::::::
UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
COVID-19
:: Coronavirus disease 2019 (COVID-19) Situation Report 42: occupied Palestinian territory, issued 3 September 2020, information for period: 5 March – 3 September 2020
East Africa Locust Infestation
:: Desert Locust situation update – 2 September 2020
::::::
::::::
WHO & Regional Offices [to 5 Sep 2020]
3 September 2020 Departmental news
WHO convenes expert group for behaviour change
31 August 2020 News release
In WHO global pulse survey, 90% of countries report disruptions to essential health services since COVID-19 pandemic
[See Milestones above for detail]
::::::
Weekly Epidemiological Record, 4 September 2020, vol. 95, 36 (pp. 417–440)
Global leprosy (Hansen disease) update, 2019: time to step-up prevention initiatives
COVID-19 update
::::::
WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: 04 September 2020 Decisive and timely: Mauritius’ response curbs COVID-19
:: 03 September 2020 African countries engaging in ground-breaking COVID-19 vaccine initiative
WHO Region of the Americas PAHO
No new digest content identified
WHO South-East Asia Region SEARO
No new digest content identified
WHO European Region EURO
:: Europe lights the way for schooling during the COVID-19 pandemic and beyond 04-09-2020
:: Unleashing the potential of vaccines for a healthier Europe 02-09-2020
:: Athens protects vulnerable communities during COVID-19 01-09-2020
:: Towards a consensus on safe schooling in the WHO European Region during the COVID-19 pandemic 31-08-2020
WHO Eastern Mediterranean Region EMRO
:: Statement by WHO’s Regional Director on an upsurge in the number of COVID-19 cases in the Eastern Mediterranean Region
3 September 2020 – Our Region is close to approaching a new grim milestone of 2 million COVID-19 cases: as of 1 September, the cumulative number of cases in the Region is now more than 1 936 221, with 51 326 deaths. Of greatest concern is a new upsurge in cases in a number of countries, highlighting the negative consequences of lack of adherence to public health measures….
WHO Western Pacific Region
:: Protecting older people against COVID-19 3 September 2020
CDC/ACIP [to 5 Sep 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases
No new digest content identified
Africa CDC [to 5 Sep 2020]
http://www.africacdc.org/
News
Press Releases
Training of trainers on infection prevention and control for COVID-19 concludes in DRC
2 September 2020
Press Releases
Africa CDC launches web-based tool to better manage public health emergency workforce deployments
1 September 2020
Press Releases
Team Europe: Germany and European Union jointly support African Union’s response to COVID-19
1 September 2020
China CDC
http://www.chinacdc.cn/en/
No new digest content identified.
National Health Commission of the People’s Republic of China
http://en.nhc.gov.cn/
News
Sept 5: Daily briefing on novel coronavirus cases in China
On Sept 4, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 10 new cases of confirmed infections.
Four Chinese COVID-19 vaccines undergoing phase-3 clinical trials
2020-08-31
BEIJING — Four Chinese COVID-19 vaccine candidates have started international phase-3 clinical trials, according to the State Council joint prevention and control mechanism against COVID-19.
Some of the phase-3 trials are expected to complete the first round of vaccinations in early September, with preliminary data expected as early as November.
Phase-3 clinical trials usually involve thousands of people to verify the safety and effectiveness of the vaccines, which are key to their market approval.
As the epidemic has been brought under control in China, the country no longer has conditions for large-scale clinical trials, so all the phase-3 trials are being carried out overseas.
Two inactivated COVID-19 vaccines developed by the China National Biotec Group (CNBG) have been approved for phase-3 clinical trials in several countries in the Middle East and South America, involving more than 30,000 people, according to Yang Xiaoming, president of the CNBG…
Announcements
Paul G. Allen Frontiers Group [to 5 Sep 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.
BARDA – U.S. Department of HHS [to 5 Sep 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.
BMGF – Gates Foundation [to 5 Sep 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
Bill & Melinda Gates Medical Research Institute [to 5 Sep 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.
CARB-X [to 5 Sep 2020]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
No new digest content identified.
CEPI – Coalition for Epidemic Preparedness Innovations [to 5 Sep 2020]
http://cepi.net/
Latest News
321 vaccine candidates against COVID-19 now in development
04 Sep 2020 By CEPI
[See COVID-19 Vaccines above for detail]
EDCTP [to 5 Sep 2020]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
No new digest content identified.
Emory Vaccine Center [to 5 Sep 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.
European Medicines Agency [to 5 Sep 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: EMA receives application for marketing authorisation of Dexamethasone Taw for COVID-19
Last updated: 02/09/2020
News: EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support (updated)
CHMP, Last updated: 02/09/2020
European Vaccine Initiative [to 5 Sep 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.
FDA [to 5 Sep 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
September 4, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 4, 2020
… The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights of the agency’s response efforts…
September 3, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 3, 2020
September 2, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 2, 2020
…Today, the FDA updated its guidance, “Investigational COVID-19 Convalescent Plasma,” to provide additional information related to the recently issued Emergency Use Authorization (EUA) for the use of COVID-19 convalescent plasma to treat hospitalized patients with COVID-19. This update includes a discussion regarding FDA’s intent to exercise temporary enforcement discretion regarding the IND requirements for the use of this product when blood establishments, hospitals, and health care providers collect plasma that does not meet the Conditions of Authorization of the EUA. The revised guidance continues to provide recommendations for health care providers who wish to administer and study convalescent plasma under an Investigational New Drug Application. In addition, the agency updated the web page, “Recommendations for Investigational COVID-19 Convalescent Plasma,” which also provides this information….
September 1, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 1, 2020
August 31, 2020 – Coronavirus (COVID-19) Update: Daily Roundup August 31, 2020
… he FDA broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease…
Fondation Merieux [to 5 Sep 2020]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation co-organized event
ACDx Webinar focused on the critical role of diagnostics in the COVID-19 pandemic – 4 regional perspectives
September 15, 2020 – Webinar 3:00pm to 5:00pm (CET)
The COVID-19 pandemic has highlighted the major role of diagnostics in the patient’s management. Around the globe, the regions and countries have put in place different diagnostics strategies and policies to tackle this COVID-19 sanitary crisis.
The Mérieux Foundation and the London School of Hygiene & Tropical Medicine (LSHTM) are jointly organizing a 2 hour webinar on September 15 at 3pm (CET) on the critical role of diagnostics in the COVID-19 crisis management to share best practices & lessons learnt from experiences around the world.
Gavi [to 5 Sep 2020]
https://www.gavi.org/
News releases
No new digest content identified.
GHIT Fund [to 5 Sep 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.
Global Fund [to 5 Sep 2020]
https://www.theglobalfund.org/en/news/
News/Updates
News
Qatar Increases its Contribution to the Global Fund Fivefold
03 September 2020
Qatar and the Global Fund today signed a multi-year contribution agreement for US$50 million for 2020-2022, strengthening their partnership in fighting infectious diseases and in building resilient systems for health.
Hilleman Laboratories [to 5 Sep 2020]
http://www.hillemanlabs.org/
No new digest content identified.
Human Vaccines Project [to 5 Sep 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Release
No new digest content identified.
IAVI [to 5 Sep 2020]
https://www.iavi.org/newsroom
FEATURES
No new digest content identified.
International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
No new digest content identified.
International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
No new digest content identified.
IFFIm
http://www.iffim.org/
Announcements
No new digest content identified.
IFRC [to 5 Sep 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Americas, Bahamas
Hurricane Dorian anniversary: Thousands supported during a global pandemic and in the midst of hurricane season
Panama/Geneva, 1 September 2020 — One year after Hurricane Dorian devastated communities in the Bahamas, the Red Cross has assisted thousands of families with emergency relief, financial assistance and support for long-term recovery.
IRC International Rescue Committee [to 5 Sep 2020]
http://www.rescue.org/press-release-index
Media highlights {Selected]
Press Release
COVID-19 cases increase 220% in month since Beirut explosion
September 1, 2020
IVAC [to 5 Sep 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
Webinar: Avoiding Barriers to Access for a COVID-19 Vaccine
Register: The International Vaccine Access Center (IVAC) on September 16, 2020 at 8:00 EDT/21:00 KST will host a 60-minute webinar, “Avoiding Barriers to Access for a COVID-19 Vaccine.”
Description: Even before the COVID-19 pandemic, countries worked to overcome a myriad of challenges when introducing new safe and effective vaccines. While policy makers and health advocates addressed barriers, from understanding disease burden and cost effectiveness to establishing cold chain systems, preventable diseases spread, sicken populations, and cost lives. Learning from the past failures of vaccine introductions will be crucial for ensuring equitable access to a COVID-19 vaccine. Leaders and scientists in the international vaccine field will discuss the barriers to vaccine access we must overcome to avoid and the role the international community will play in promoting equity in delivering a COVID-19 vaccine.
IVI [to 5 Sep 2020]
http://www.ivi.int/
Selected IVI News & Announcements
No new digest content identified.
JEE Alliance [to 5 Sep 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.
MSF/Médecins Sans Frontières [to 5 Sep 2020]
http://www.msf.org/
Latest [Selected Announcements]
Lebanon
“The explosion did not distinguish between its victims and neither shou…
Interview 4 Sep 2020
DRC Ebola outbreaks
Crisis update – September 2020
Crisis Update 4 Sep 2020
DRC Ebola outbreaks
Responding to new Ebola outbreak in Équateur province
Project Update 4 Sep 2020
Coronavirus COVID-19 pandemic
Greek police enforce unwarranted and cruel quarantine of Moria camp …
Statement 3 Sep 2020
Mediterranean migration
Sea-Watch 4 is allocated a port of safety 11 days after first rescue
Interview 2 Sep 2020
Nigeria
“When I think about going home, I remind myself that a live dog is better than a …
Voices from the Field 1 Sep 2020
Cameroon
A hospital at the heart of the North-West crisis in Cameroon
Project Update 1 Sep 2020
National Vaccine Program Office – U.S. HHS [to 5 Sep 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC Meetings
September 23-24, 2020 Meeting (Virtual)
February 4-5, 2021 NVAC Meeting
June 16-17, 2021 NVAC Meeting
NIH [to 5 Sep 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH continues to boost national COVID-19 testing capacity
September 2, 2020 — New laboratory and point-of-care tests to enable access and rapid result.
NIH-supported study to track prevalence and impact of SARS-CoV-2 among pregnant women in low- and middle-income countries
September 1, 2020 — The study will follow women through pregnancy and 12 months after childbirth.
Phase 3 Clinical Testing in the US of AstraZeneca COVID-19 Vaccine Candidate Begins
August 31, 2020 — The trial will enroll approximately 30,000 adult volunteers at 80 sites in the United States to evaluate if the candidate vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19).
People with intellectual and developmental disabilities disproportionately affected by COVID-19
August 28, 2020 — NIH-funded researchers call for restoration of support services or alternatives.
PATH [to 5 Sep 2020]
https://www.path.org/media-center/
Press Releases
Expanding access to HPV vaccines: PATH to evaluate safety and immunogenicity of new HPV vaccine
August 31, 2020 by Tara Newton
PATH, Innovax, KfW, and the Bill & Melinda Gates Foundation are partnering to expand options for human papillomavirus (HPV) vaccines in the countries that need them most.
Sabin Vaccine Institute [to 5 Sep 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.
UNAIDS [to 5 Sep 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
4 September 2020
Guyana’s HIV food bank comes to the rescue during COVID-19
4 September 2020
Evaluation of UNFPA support to the HIV response
UNICEF [to 5 Sep 2020]
https://www.unicef.org/media/press-releases
Selected Press releases/Announcements
Press release
09/03/2020
UNICEF to lead procurement and supply of COVID-19 vaccines in world’s largest and fastest ever operation of its kind
UNICEF will work with manufacturers and partners on the procurement of vaccine doses as well as freight, logistics and storage of COVID-19 vaccines, on behalf of global COVAX Facility
Press release
09/03/2020
Increased support vital to help children affected by Beirut explosions back to school, one month after devastating explosions
183 education facilities damaged or destroyed by the blasts, affecting over 77,000 children and youth as new school year approaches
Press release
09/03/2020
World’s richest countries grappling with children’s reading and math skills, mental well-being and obesity
New report ranks the Netherlands, Denmark and Norway the best among EU and OECD countries for child wellbeing; and highlights substantial threats to child well-being due to the COVID-19 pandemic
Press release
09/01/2020
Business, government, multilateral agency and UN leaders commit to connecting children and young people to the internet by 2030
As half the world’s population remain unconnected, a virtual ‘Generation Unlimited’ event calls for urgent action and investment to bridge the digital divide and scale-up digital learning and skilling opportunities
Unitaid [to 5 Sep 2020]
https://unitaid.org/
Featured News
03 September 2020 | Press releases
Life-saving infant oxygen device awarded Unitaid funding
Vaccination Acceptance Research Network (VARN) [to 5 Sep 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.
Vaccine Confidence Project [to 5 Sep 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.
Vaccine Education Center – Children’s Hospital of Philadelphia [to 5 Sep 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
Wellcome Trust [to 5 Sep 2020]
https://wellcome.ac.uk/news
No new digest content identified.
The Wistar Institute [to 5 Sep 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.
WFPHA: World Federation of Public Health Associations [to 5 Sep 2020]
https://www.wfpha.org/
Latest News
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World Organisation for Animal Health (OIE) [to 5 Sep 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
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ARM [Alliance for Regenerative Medicine] [to 5 Sep 2020]
https://alliancerm.org/press-releases/
Press Releases
The Alliance for Regenerative Medicine Applauds New Rule From the Centers for Medicare & Medicaid Services Promoting Access to Innovative Therapies
Washington, DC September 2, 2020
The Alliance for Regenerative Medicine (ARM) applauds the Centers for Medicare and Medicaid Services’ (CMS) decision to finalize a new diagnosis-related group (DRG) for chimeric antigen receptor T cell (CAR-T) therapies in their FY21 Inpatient Prospective Payment System (IPPS) rule. This is a crucial step forward for patient access to life-changing therapies, and the result of multi-year collaboration among ARM, its members, regulators, and a diverse group of other stakeholders.
BIO [to 5 Sep 2020]
https://www.bio.org/press-releases
Press Releases
Biotech Leaders Outline Principles to Ensure the “Public’s Trust” in New Medical Products for Eradicating Covid-19
September 3, 2020
[See COVID-19 Vaccines above for detail]
DCVMN – Developing Country Vaccine Manufacturers Network [to 5 Sep 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.
ICBA – International Council of Biotechnology Associations [to 5 Sep 2020]
https://internationalbiotech.org/
News
No new digest content identified.
IFPMA [to 5 Sep 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Biopharma industry updates on COVID-19 treatments progress and warns about upholding regulatory standards of quality
03 September 2020
[See COVID-19 Vaccines above for detail]
PhRMA [to 5 Sep 2020]
http://www.phrma.org/
Selected Press Releases, Statements
Coming together to fight COVID-19: A conversation with Paul Hudson, CEO of Sanofi
Stephen J. Ubl | September 2, 2020
Over the last seven months, our industry has been working around the clock to combat the COVID-19 virus, including developing effective therapeutics to treat COVID-19 and vaccines to prevent future infections. I had the opportunity to connect with Paul Hudson, CEO of Sanofi, about the fight against COVID-19.
Journal Watch
Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focu-s on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.
If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org
American Journal of Infection Control
September 2020 Volume 48, Issue 9, p975-1132
http://www.ajicjournal.org/current
Major Articles
COVID-19 infection: Strategies on when to discontinue isolation, a retrospective study
Amelita Woodruff, Katherine L Walsh, Dacre Knight, Joan M. Irizarry-Alvarado
p1032–1036
Published online: July 4, 2020
American Journal of Infection Control
September 2020 Volume 48, Issue 9, p975-1132
http://www.ajicjournal.org/current
Hand sanitizers: A review of ingredients, mechanisms of action, modes of delivery, and efficacy against coronaviruses
Andrew P. Golin, Dexter Choi, Aziz Ghahary
p1062–1067
Published online: June 18, 2020
American Journal of Infection Control
September 2020 Volume 48, Issue 9, p975-1132
http://www.ajicjournal.org/current
State of the Science Review
Reducing antibiotic prescribing and addressing the global problem of antibiotic resistance by targeted hygiene in the home and everyday life settings: A position paper
Jean-Yves Maillard, Sally F. Bloomfield, Patrice Courvalin, Sabiha Y. Essack, Sumanth Gandra, Charles P. Gerba, Joseph R. Rubino, Elizabeth A. Scott
p1090–1099
Published online: April 17, 2020
American Journal of Preventive Medicine
September 2020 Volume 59, Issue 3, p309-468
http://www.ajpmonline.org/current
Research Articles
Human Papillomavirus Immunization in Rural Primary Care
Rose Gunn, Laura K. Ferrara, Caitlin Dickinson, Isabel Stock, Jennifer Griffith-Weprin, Amy Wiser, Brigit Hatch, L.J. Fagnan, Patricia A. Carney, Melinda M. Davis
p377–385
Published online: June 27, 2020
American Journal of Preventive Medicine
September 2020 Volume 59, Issue 3, p309-468
http://www.ajpmonline.org/current
Physicians’ Use of Evidence-Based Strategies to Increase Adult Vaccination Uptake
Laura P. Hurley, Megan C. Lindley, Mandy A. Allison, Sean T. O’Leary, Lori A. Crane, Michaela Brtnikova, Brenda L. Beaty, Allison Kempe
e95–e103
Published online: May 21, 2020
American Journal of Public Health
September 2020 110(9)
http://ajph.aphapublications.org/toc/ajph/current
IMMIGRATION
Immigrants and Access to Care: Public Health Must Lead the Way in Changing the Nation’s Narrative
Chronic Disease, Cardiovascular Disease, Immigration, Health Policy, Race/Ethnicity, Hispanics/Latinos, Health Service Delivery, Access to Care
Maia Ingram
American Journal of Public Health
September 2020 110(9)
http://ajph.aphapublications.org/toc/ajph/current
PUBLIC SERVICE
Incentivized Public Service Response to COVID-19 in Rural and Marginalized Urban Communities
Rural Health, Public Health Workers, Health Policy, Community Health, Health Service Delivery
Irene Torres, Daniel F. López-Cevallos and Fernando Sacoto
110(9), pp. 1344–1345
American Journal of Public Health
September 2020 110(9)
http://ajph.aphapublications.org/toc/ajph/current
DEMOCRACY
COVID-19 Emergency Measures Are Hurting Democracy Globally
Global Health, Government, Human Rights, Health Law, Injury/Emergency Care/Violence
Stephen Thomson and Eric C. Ip
110(9), pp. 1356–1357
BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 5 Sep 2020)
The effect of maternal poliovirus antibodies on the immune responses of infants to poliovirus vaccines
Maternal poliovirus antibodies could provide passive immunity to the newborns from poliovirus infection during their first few months of life, but they may impair the immune responses of infants to the poliovirus vaccine as well. In our study, we pooled the data from three clinical trials of the inactivated poliovirus vaccine (IPV) based on Sabin strains to investigate the effect of maternal poliovirus antibodies on the immune responses of infants to poliovirus vaccines.
Authors: Siyue Jia, Rong Tang, Guifan Li, Yuemei Hu and Qi Liang
Citation: BMC Infectious Diseases 2020 20:641
Content type: Research article
Published on: 31 August 2020
BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 5 Sep 2020)
South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation
Whenever South African (SA) research institutions share human biological material and associated data for health research or clinical trials they are legally compelled to have a material transfer agreement (MTA) in place that uses as framework the standard MTA newly gazetted by the South African Minister of Health (SA MTA).
Authors: Donrich W. Thaldar, Marietjie Botes and Annelize Nienaber
Citation: BMC Medical Ethics 2020 21:85
Content type: Debate
Published on: 3 September 2020
BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 5 Sep 2020)
Spatial distribution of incomplete immunization among under-five children in Ethiopia: evidence from 2005, 2011, and 2016 Ethiopian Demographic and health survey data
An estimate of 2–3 million children under 5 die in the world annually due to vaccine-preventable disease. In Ethiopia, incomplete immunization accounts for nearly 16% of under-five mortality, and there is spat…
Authors: Mequannent Sharew Melaku, Araya Mesfin Nigatu and Wondewossen Zemene Mewosha
Citation: BMC Public Health 2020 20:1362
Content type: Research article
Published on: 5 September 2020
Bulletin of the World Health Organization
Volume 98, Number 9, September 2020, 581-644
https://www.who.int/bulletin/volumes/98/9/en/
EDITORIALS
Gaps in access to essential medicines and health products for noncommunicable diseases and mental health conditions
— Ren Minghui, Mariangela Simao, Bente Mikkelsen, Dévora Kestel, Andrew Ball & Zsofia Szilagyi
http://dx.doi.org/10.2471/BLT.20.272658
Bulletin of the World Health Organization
Volume 98, Number 9, September 2020, 581-644
https://www.who.int/bulletin/volumes/98/9/en/
COVID-19 response measures and violence against children
— Amiya Bhatia, Camilla Fabbri, Ilan Cerna-Turoff, Clare Tanton, Louise Knight, Ellen Turner, Michelle Lokot, Shelley Lees, Ben Cislaghi, Amber Peterman, Alessandra Guedes & Karen Devries
http://dx.doi.org/10.2471/BLT.20.263467
vaccines and global health :: ethics and policy 