Trump lied about science

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

 

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

Global citizen deliberation on genome editing

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

 

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

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

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

 

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

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

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

 

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

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

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

 

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

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

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

 

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

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

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

 

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

Vaccination and Vaccine Effectiveness: A Commentary of Special Issue Editors

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

 

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

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

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

 

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

Media/Policy Watch

Media/Policy Watch
This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.
We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

 

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 19 Sep 2020
[No new, unique, relevant content]

 

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

 

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

 

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

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

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

 

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

 

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

 

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

 

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

 

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

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

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

 

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

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

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

Think Tanks et al

Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 19 Sep 2020
Up Front
Politics is wrecking America’s pandemic response
Jonathan Rothwell and Christos Makridis
Thursday, September 17, 2020

Center for Global Development [to 19 Sep 2020]
http://www.cgdev.org/page/press-center
Accessed 19 Sep 2020
September 15, 2020
Using Machine Learning for Healthcare Resource Allocation in COVID-19: Opportunities and Challenges for LMICs
One of the greatest challenges for any health system facing COVID-19 is the equitable and efficient allocation of scarce resources. With health systems stretched, and concerns about COVID-19 vaccine nationalism, machine learning presents a valuable opportunity to help guide decisions on the allocation of scarce resources like hospital beds, staff, and vaccines, in low- and middle-income countries (LMICs).
Anukrat Bhansali and Vageesh Jain

Chatham House [to 19 Sep 2020]
https://www.chathamhouse.org/
[No new relevant content]

 

CSIS
https://www.csis.org/
Accessed 19 Sep 2020
Commentary
Advice to the Independent Panel on Pandemic Preparedness and Response
September 17, 2020 | By J. Stephen Morrison, Carolyn Reynolds

On Demand Event
Online Event: CSIS Book Launch with Heidi J. Larson – Stuck
September 16, 202

 

Council on Foreign Relations
http://www.cfr.org/
Accessed 19 Sep 2020
September 14, 2020
Cybersecurity
The Cyber Side of Vaccine Nationalism
Vaccine nationalism has given rise to a new wave of cyber espionage targeting COVID-19 vaccine research.
Blog Post by David P. Fidler Digital and Cyberspace Policy Program
In the COVID-19 pandemic, vaccine nationalism has become an important and controversial phenomenon. Rather than cooperate through global mechanisms to develop, manufacture, and distribute a vaccine against the coronavirus, countries with the means to do so have prioritized national access to a vaccine. Despite warnings about its adverse consequences for global health and international cooperation, vaccine nationalism is not abating. The political momentum of vaccine nationalism can be found in not only the pharmaceutical realm but also cyberspace…

 

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 19 Sep 2020
[No new relevant content]

Vaccines and Global Health: The Week in Review :: 12 September 2020

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

Global collaboration for health: rhetoric versus reality

Featured Journal Content

 

The Lancet
Sep 12, 2020 Volume 396 Number 10253 p735-798, e25-e29
https://www.thelancet.com/journals/lancet/issue/current
Editorial
Global collaboration for health: rhetoric versus reality
The Lancet
The 75th session of the UN General Assembly (UNGA) opens on Sept 15, 2020. Being held remotely for the first time, the meeting will inevitably be dominated by the COVID-19 pandemic, but other issues on the agenda that have resonance for global health include the climate crisis, peace, disarmament, and humanitarian assistance. Underpinning this year’s agenda is the UN theme of multilateralism, under the banner ”The future we want, the United Nations we need: reaffirming our collective commitment to multilateralism”. Yet the meeting comes at a time when global collaboration and cooperation are in disarray.

The UNGA is traditionally built on bold rhetoric of global collaboration and exhaustive debate over some of the world’s most intractable problems. But rather than expressing a shared vision for a common future, countries are now undermining global cooperation through rising nationalism, open hostility towards multilateral institutions, and a growing tendency to look after their own interests—eg, rushing to secure supplies of potential COVID-19 vaccines. Health is precariously caught in the middle of these tensions. Science has become increasingly politicised, with multiple and conflicted interests at play, and often little sense of solidarity within or between nations.

 

An immediate casualty of these opposing forces is the global effort towards vaccines for COVID-19. COVAX, the COVID-19 Global Access Facility, is led by WHO; Gavi, The Vaccine Alliance; and the Coalition for Epidemic Preparedness Innovations, and aims to rapidly develop and equitably distribute effective vaccines. Variable commitment to COVAX reflects the tension between nationalism and collaboration. 170 countries plan to participate, but the USA, for one, is opting not to join COVAX. Instead, the USA has secured bilateral deals with several pharmaceutical companies for millions of doses of promising COVID-19 vaccines. Similar deals have been struck by Australia, the EU, and the UK. In July, Médecins Sans Frontières warned that “These bilateral deals will reduce the initial global vaccine stocks available for vulnerable groups in poorer countries and undermine global efforts to ensure fair allocation”.

Insufficient collaboration is also jeopardising the Pan American Health Organization, with many member states, including Brazil, Venezuela, and Mexico, withholding essential funding at a time when Latin America is under mounting pressure from COVID-19. Meanwhile, the USA continues its deeply disappointing withdrawal from WHO.

The climate emergency is another subject on which rhetoric has fallen flat in the face of nationalistic inaction. The global response to COVID-19 depends heavily on the idea of creating a better future for human and planetary health, and commitment to this approach is non-negotiable for sustainable recovery. It is disappointing that the UNGA’s formal general agenda does not more extensively cover climate change beyond the item “Protection of global climate for present and future generations of humankind”, although there is a Summit on Biodiversity on Sept 30, as well as activities across New York City.

Hopefully, the summit will also return the UNGA’s focus to the Sustainable Development Goals, which must still be met by 2030, and to defining a post-2020 biodiversity framework. An early indication that nations might work to protect health in the face of climate change as laid out in this year’s WHO manifesto for a healthy and green recovery from COVID-19 is seen in the commitment to the Resilient Recovery Platform. Launched in Japan on Sept 3, 2020, the platform is a global sharing of policy and actions to address the response to COVID-19 coupled with the response to the climate emergency, with stakeholders such as governments, businesses, non-governmental organisations, and civil society. The participation of 80 countries shows a willingness to engage in overhauling socioeconomic models towards a sustainable future. But will it be translated into action?

Global solidarity cannot be garnered through rhetoric alone. COVID-19 has brought into clear view that every person’s health is interconnected, and the UNGA is a platform with the power to reorientate global interests in such a way as to protect the health and lives of all people in every nation. The need for global cooperation has never been more visible or more crucial. Unfortunately, the UN has so far in 2020 not been able to transform rhetoric into reality. This should give pause for serious reflection. Global crises call for global responses, and we have yet to see them.

COVID-19 Vaccines, Therapeutics, Diagnostics

Featured Journal Content

 

COVID-19 Vaccines, Therapeutics, Diagnostics

Statement from the first ACT-Accelerator Facilitation Council meeting
10 September 2020 WHO
As Members and Partners of the Facilitation Council of the ‘Access to COVID-19 Tools Accelerator’ (ACT- Accelerator), on the occasion of the Council’s launch meeting;

We share the vision of the ACT-Accelerator as a unique international collaboration to fast-track the development and equitable deployment of COVID-19 vaccines, therapeutics and diagnostics globally while strengthening related health systems;

We thank the World Health Organization and the European Commission for their leadership in co- convening this first meeting of the Facilitation Council at this crucial time, as the COVID-19 pandemic continues to have a devastating impact on the health, societies and economies of all countries, the consequences of which have disproportionately affected poor and vulnerable populations;

We welcome South Africa and Norway as the Council’s co-chairs;

We recognize that the fastest and most effective solution to the COVID-19 crisis, and the full mitigation of its health, social and economic consequences, is through global multilateral collaboration and international solidarity that supports all countries and populations, including the world’s poorest and at-risk populations such as women and children;

We fully align with the ACT-Accelerator goal of rapidly reducing the risk of severe COVID-19 disease globally, which will in turn bolster the capacity of health systems to safely and effectively manage COVID- 19 and restore the global confidence needed to resume economic and societal activity;

We appreciate the leadership and work of the ACT-Accelerator Pillar co-conveners and their partners for the substantial achievements to date, while recognizing the considerable challenges they face to realize the full potential of this unprecedented global collaboration;

We consider the ACT-Accelerator an integral part of the implementation of the World Health Assembly Resolution (WHA73.1(3)) and that it responds fully to the G20 Leaders’ Commitment of 26 March 2020, as both highlighted the need for end-to-end solutions to accelerate the development and equitable, universal deployment of life saving COVID-19 vaccines, therapeutics and diagnostics;

 

We acknowledge the urgency of catalysing a step-change in political support and financing for the ACT- Accelerator in order to enable it to deliver on its mission of accelerating the discovery and deployment of new COVID-19 tools to all people, everywhere;

Accordingly, we will:
[1] Provide sustained political leadership to galvanize and harness broad international support for the ACT-Accelerator, including in key upcoming fora such as the UN General Assembly, the G20 and G7 processes, the Paris Peace Forum and IMF/World Bank Group meetings and through our respective regional cooperation groups and national processes;

[2] Advocate in support of the ACT-Accelerator Investment Case in order to secure as a matter of urgency the financial resources required to scale-up for impact and change the course of the pandemic;

[3] Honour and realize our shared commitment to leave no one behind in this crisis, by working to ensure that all countries and populations have early, affordable and equitable access to the new vaccines, therapeutics and diagnostics that the ACT-Accelerator is pursuing.

COVID-19 Vaccines – Development Standards/Regulatory Review/Commitments

Featured Journal Content

COVID-19 Vaccines – Development Standards/Regulatory Review/Commitments

Press Release
Biopharma Leaders Unite to Stand with Science
Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

NEW YORK–(BUSINESS WIRE)– Sep. 8, 2020 The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline plc), Johnson & Johnson, Merck, known as MSD outside the United States and Canada, Moderna, Inc., Novavax, Inc., Pfizer Inc., and Sanofi today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines. All nine CEOs signed the following pledge:

“We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.

“The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

“ Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:
:: Always make the safety and well-being of vaccinated individuals our top priority.
:: Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
:: Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
:: Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.”

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

::::::

FDA Voices 09/11/2020
The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health
By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
[Excerpt]
…The FDA’s career scientists and physicians are helping to facilitate the development and evaluation of safe and effective COVID-19 vaccines. These professionals have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of vaccines intended to prevent infectious diseases. They are experts in clinical trial design and analysis and synthesizing and evaluating tremendous amounts of data to determine whether a vaccine has been shown to be safe and effective. These experts are responsible for assessing the adequacy of manufacturing and the facilities where vaccines are made, which are critical to producing high-quality vaccines, and for post-marketing safety surveillance, using a wide variety of surveillance systems and data mining to continually review safety after a vaccine is approved.

The FDA is often held up as the “gold standard” of regulatory agencies around the globe. What’s at the core of these standards are the agency’s regulatory independence and science-based decision-making.  As with all products we regulate, we will follow the science and data in our decision making regarding COVID-19 vaccines. It is because the FDA is a science-based agency that we say this with the clarity of conviction. The dedicated career public health professionals who will be involved in evaluating the data submitted to the FDA in requests for Emergency Use Authorization (EUA) and in Biologics License Applications (BLAs) for COVID-19 vaccines are committed to decision making based on science and data. They are fathers, mothers, sisters, brothers, grandparents and more – and they (and their families) are directly impacted by the work they do. They are exactly who you want making decisions regarding vaccine safety and effectiveness.

No time in recent memory has shone as bright a light on the work of FDA review staff as the COVID-19 pandemic. We understand that a lot of people may not have information about vaccine development or how the FDA determines whether or not to approve a vaccine – and may not have given it much thought – at least until now.

With so much at stake, we understand the importance of being as transparent as possible about the work we do, including how we will make decisions regarding COVID-19 vaccines. The publication of our guidance was an important step – we firmly believe that transparency regarding the FDA’s thinking about the scientific data needed to support approval of safe and effective vaccines will help build public confidence in the FDA’s evaluation process, which will be critical in ensuring the use of COVID-19 vaccines once available.

An upcoming key milestone is the meeting of our Vaccines and Related Biological Products Advisory Committee on October 22, at which the committee will discuss publicly the general development of COVID-19 vaccines. While this meeting is not intended to discuss any particular vaccine candidates, the agency is also prepared to rapidly schedule additional meetings of this Committee upon submission of any BLAs or requests for EUAs to further ensure transparency.

The FDA has been asked what regulatory path will be used to make COVID-19 vaccines available (i.e., will there be an EUA, or will the FDA approve a BLA?). The short answer is, taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request or BLA to the FDA. The agency will review EUA requests and BLAs received and make appropriate determinations by looking at the totality of the available scientific evidence. For a vaccine for which there is adequate manufacturing information, issuance of an EUA may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine, but before the manufacturer has submitted all of the various data elements normally required and/or the FDA has completed its formal review of the BLA.

As we have said, these decisions will be firmly rooted in science. We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake….

COVID-19 Vaccines – Development Status/Scorecard

Featured Journal Content

 

COVID-19 Vaccines – Development Status/Scorecard

IVI [to 12 Sep 2020]
http://www.ivi.int/
Selected IVI News & Announcements
IVI to ready clinical trial sites for COVID-19 vaccine efficacy trials in 4 countries
September 9, 2020 – SEOUL, South Korea – The International Vaccine Institute (IVI) announced today that the Bill & Melinda Gates Foundation awarded close to 1.5 million USD to IVI to support clinical trial site preparedness in four African and Asian countries to potentially support future COVID-19 Phase III efficacy vaccine trials.

Following successful completion of early-stage clinical trials of COVID-19 vaccine candidates, it will be essential to transition to efficacy trials at different sites around the world with high disease burden, including those in resource-limited settings. To ensure these sites are prepared for efficacy trials with the necessary technical capability, trained staff, sufficient trial participants, and a thorough assessment of prevailing COVID-19 burden, IVI aims to bolster in-country capacity at select sites by 4Q2020.

Dr Florian Marks, Deputy Director General of Epidemiology, Public Health, Impact, and Clinical Development at IVI, said: “The COVID-19 threat is worldwide, which means preparations for the development and delivery of safe and effective vaccines must also be a global project. It is imperative that lack of resources does not equate to exclusion, that COVID-19 vaccines be regarded as global public goods from the outset, and that equal access is ensured. We look forward to working with our long-time partners in Africa and Asia to accelerate the global push toward a COVID-19 vaccine solution.”

IVI currently conducts active projects in Africa and Asia, including disease prevention and surveillance for cholera and typhoid in Mozambique and Ghana, respectively, as well as a Phase III clinical trial for a novel typhoid conjugate vaccine in thePhilippines. IVI also received funding from the Swedish International Development Cooperation Agency (Sida) this May to strengthen COVID-19 surveillance in Madagascar and Burkina Faso.

 

::::::

Selected Developer Announcements

COVID-19 vaccine AZD1222 clinical trials resumed in the UK
12 September 2020 14:20 BST
Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.

On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators. The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume.

AstraZeneca and the University of Oxford, as the trial sponsor, cannot disclose further medical information. All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards…

Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial
September 12, 2020
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced today that they have submitted an amended protocol to the U.S. Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations…

Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2
:: The proposed agreement is intended to provide a supply of 200 million doses and an option to purchase additional 100 million doses, with deliveries starting by the end of 2020, subject to regulatory approval
:: The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium
:: Pfizer and BioNTech are on track to seek regulatory review of BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021
September 09, 2020

Sinovac Reports Preliminary Phase I/II Results of COVID-19 Vaccine in Elderly Volunteers
September 09, 2020
BEIJING–(BUSINESS WIRE)–Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, announced that the inactivated COVID-19 vaccine candidate developed by Sinovac Life Sciences (Sinovac LS), or “CoronaVac,” shows good safety and immunogenicity on healthy adults aged 60 and above from its phase I/II clinical studies conducted in China, which is comparable to the result in healthy adults aged from 18 to 59 in the earlier studies.
The phase I/II clinical trial on elderly volunteers were randomized, double-blinded and placebo controlled trials with two-dose immunization scheduled at 28 day intervals…

COVID-19 Vaccines – Transport/Logistics

Featured Journal Content

 

COVID-19 Vaccines – Transport/Logistics

The Time to Prepare for COVID-19 Vaccine Transport is Now
Press release
9 SEPTEMBER/ GENEVA  – The International Air Transport Association (IATA) urged governments to begin careful planning with industry stakeholders to ensure full preparedness when vaccines for COVID-19 are approved and available for distribution. The association also warned of potentially severe capacity constraints in transporting vaccines by air.

 

Preparedness
Air cargo plays a key role in the distribution of vaccines in normal times through well-established global time- and temperature-sensitive distribution systems. This capability will be crucial to the quick and efficient transport and distribution of COVID-19 vaccines when they are available, and it will not happen without careful planning, led by governments and supported by industry stakeholders.

“Safely delivering COVID-19 vaccines will be the mission of the century for the global air cargo industry. But it won’t happen without careful advance planning. And the time for that is now. We urge governments to take the lead in facilitating cooperation across the logistics chain so that the facilities, security arrangements and border processes are ready for the mammoth and complex task ahead,” said IATA’s Director General and CEO, Alexandre de Juniac.

“Delivering billions of doses of vaccine to the entire world efficiently will involve hugely complex logistical and programmatic obstacles all the way along the supply chain. We look forward to working together with government, vaccine manufacturers and logistical partners to ensure an efficient global roll-out of a safe and affordable COVID-19 vaccine,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance.

Facilities:  Vaccines must be handled and transported in line with international regulatory requirements, at controlled temperatures and without delay to ensure the quality of the product. While there are still many unknowns (number of doses, temperature sensitivities, manufacturing locations, etc.), it is clear that the scale of activity will be vast, that cold chain facilities will be required and that delivery to every corner of the planet will be needed. Priorities for preparing facilities for this distribution include:
:: Availability of temperature-controlled facilities and equipment – maximizing the use or re-
purposing of existing infrastructure and minimizing temporary builds
:: Availability of staff trained to handle time- and temperature-sensitive vaccines
:: Robust monitoring capabilities to ensure the integrity of the vaccines is maintained

Security: Vaccines will be highly valuable commodities. Arrangements must be in place to keep ensure that shipments remain secure from tampering and theft. Processes are in place to keep cargo shipments secure, but the potential volume of vaccine shipments will need early planning to ensure that they are scalable.

Border Processes:  Working effectively with health and customs authorities will, therefore, be essential to ensure timely regulatory approvals, adequate security measures, appropriate handling and customs clearance. This could be a particular challenge given that, as part of COVID-19 prevention measures, many governments have put in place measures that increase processing times. Priorities for border processes include:
:: Introducing fast-track procedures for overflight and landing permits for operations carrying the COVID-19 vaccine
:: Exempting flight crew members from quarantine requirements to ensure cargo supply chains are maintained
:: Supporting temporary traffic rights for operations carrying the COVID-19 vaccines where restrictions may apply
:: Removing operating hour curfews for flights carrying the vaccine to facilitate the most flexible global network operations
:: Granting priority on arrival of those vital shipments to prevent possible temperature excursions due to delays
:: Considering tariff relief to facilitate the movement of the vaccine

 

Capacity
On top of the transport preparations and coordination needed, governments must also consider the current diminished cargo capacity of the global air transport industry. IATA warned that, with the severe downturn in passenger traffic, airlines have downsized networks and put many aircraft into remote long-term storage. The global route network has been reduced dramatically from the pre-COVID 24,000 city pairs. The WHO, UNICEF and Gavi have already reported severe difficulties in maintaining their planned vaccine programs during the COVID-19 crisis due, in part, to limited air connectivity.

“The whole world is eagerly awaiting a safe COVID vaccine. It is incumbent on all of us to make sure that all countries have safe, fast and equitable access to the initial doses when they are available. As the lead agency for the procurement and supply of the COVID vaccine on behalf of the COVAX Facility, UNICEF will be leading what could possibly be the world’s largest and fastest operation ever. The role of airlines and international transport companies will be critical to this endeavour,” said Henrietta Fore, UNICEF Executive Director.

The potential size of the delivery is enormous. Just providing a single dose to 7.8 billion people would fill 8,000 747 cargo aircraft. Land transport will help, especially in developed economies with local manufacturing capacity. But vaccines cannot be delivered globally without the significant use air cargo.

“Even if we assume that half the needed vaccines can be transported by land, the air cargo industry will still face its largest single transport challenge ever. In planning their vaccine programs, particularly in the developing world, governments must take very careful consideration of the limited air cargo capacity that is available at the moment. If borders remain closed, travel curtailed, fleets grounded and employees furloughed, the capacity to deliver life-saving vaccines will be very much compromised,” said de Juniac.

COVID-19 Vaccines Development/Distribution – Ethical Considerations

COVID-19 Vaccines Development/Distribution – Ethical Considerations

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
Abstract
Background
A sense of urgency exists to develop vaccines against SARS CoV-2, responsible for numerous global cases and deaths, as well as widespread social and economic disruption. Multiple approaches have been proposed to speed up vaccine development, including accelerated randomized controlled trials (RCT), controlled human challenge trials (CHI), and wide distribution through an emergency use authorization after collecting initial data. There is a need to examine how best to accelerate vaccine development in the setting of a pandemic, without compromising ethical and scientific norms.
Methods
Trade-offs in scientific and social value between generating reliable evidence about safety and efficacy while promoting rapid vaccine availability are examined along five ethically relevant dimensions: (1) confidence in and generalizability of data, (2) feasibility, (3) speed and cost, (4) participant risks, and (5) social risks.
Results
Accelerated individually randomized RCTs permit expeditious evaluation of vaccine candidates using established methods, expertise, and infrastructure. RCTs are more likely than other approaches to be feasible, increase speed and reduce cost, and generate reliable data about safety and efficacy without significantly increasing risks to participants or undermining societal trust.
Conclusion
Ethical analysis suggests that accelerated RCTs are the best approach to accelerating vaccine development in a pandemic, and more likely than other approaches to enhance social value without compromising ethics or science. RCTs can expeditiously collect rigorous data about vaccine safety and efficacy. Innovative and flexible designs and implementation strategies to respond to shifting incidence and test vaccine candidates in parallel or sequentially would add value, as will coordinated data sharing across vaccine trials. CHI studies may be an important complementary strategy when more is known. Widely disseminating a vaccine candidate without efficacy data will not serve the public health nor achieve the goal of identifying safe and effective SARS Co-V-2 vaccines.

::::::

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.

Featured Journal Content

 

COVID-19 Vaccines Development/Distribution – Ethical Considerations

 

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
Abstract
Background
A sense of urgency exists to develop vaccines against SARS CoV-2, responsible for numerous global cases and deaths, as well as widespread social and economic disruption. Multiple approaches have been proposed to speed up vaccine development, including accelerated randomized controlled trials (RCT), controlled human challenge trials (CHI), and wide distribution through an emergency use authorization after collecting initial data. There is a need to examine how best to accelerate vaccine development in the setting of a pandemic, without compromising ethical and scientific norms.
Methods
Trade-offs in scientific and social value between generating reliable evidence about safety and efficacy while promoting rapid vaccine availability are examined along five ethically relevant dimensions: (1) confidence in and generalizability of data, (2) feasibility, (3) speed and cost, (4) participant risks, and (5) social risks.
Results
Accelerated individually randomized RCTs permit expeditious evaluation of vaccine candidates using established methods, expertise, and infrastructure. RCTs are more likely than other approaches to be feasible, increase speed and reduce cost, and generate reliable data about safety and efficacy without significantly increasing risks to participants or undermining societal trust.
Conclusion
Ethical analysis suggests that accelerated RCTs are the best approach to accelerating vaccine development in a pandemic, and more likely than other approaches to enhance social value without compromising ethics or science. RCTs can expeditiously collect rigorous data about vaccine safety and efficacy. Innovative and flexible designs and implementation strategies to respond to shifting incidence and test vaccine candidates in parallel or sequentially would add value, as will coordinated data sharing across vaccine trials. CHI studies may be an important complementary strategy when more is known. Widely disseminating a vaccine candidate without efficacy data will not serve the public health nor achieve the goal of identifying safe and effective SARS Co-V-2 vaccines.

 

::::::

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.

Coronavirus [COVID-19] – PHEIC

EMERGENCIES

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

Weekly Epidemiological and Operational updates
last update: 11 September 2020, 20:00 GMT-4
Confirmed cases :: 28 329 790 [week ago: 26 468 031]
Confirmed deaths :: 911 877 [week ago: 871 166]

Weekly Operational Update
Coronavirus disease 2019 (COVID-19)
9 September 2020

Weekly Epidemiological Update 
Coronavirus disease 2019 (COVID-19)
7 September 2020

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

POLIO – Public Health Emergency of International Concern (PHEIC)

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 09 September 2020

Summary of new WPV and cVDPV viruses this week (AFP cases and environmental samples):
:: Afghanistan: Four WPV1 cases
:: Pakistan: Three WPV1 cases and 17 WPV1 positive environmental samples
:: Chad: three cVDPV2 cases
:: Democratic Republic of the Congo (DR Congo): 15 cVDPV2 cases
:: Sudan: eight cVDPV2 case

::::::

Statement
Polio programme accelerates efforts to respond to new polio outbreaks in Sudan and Yemen
Joint statement by WHO Regional Director for the Eastern Mediterranean Region Dr Ahmed Al Mandhari and UNICEF Regional Director for the Middle East and North Africa Region Ted Chaiban
AMMAN/CAIRO, 11 September 2020 – “The recent vaccine-derived polio outbreaks confirmed in Yemen and Sudan are consequences of increasingly low levels of immunity among children. Each outbreak has paralysed children in areas that have been extremely difficult if not impossible to reach with routine or supplementary polio vaccination for extended periods of time.

“These outbreaks do not come as a total surprise. In Sudan, extensive population movement by nomadic communities, people displaced by conflict, frequent movement between neighbouring countries and restricted access in some areas have made it enormously difficult to reach every child with vaccines. The cases in Yemen are clustered in the Sa’adah Governorate in the war-ravaged country’s north-west, an area that has very low routine immunization levels and has been inaccessible to the polio programme for more than two years. The last house-to-house campaigns in this area were in November 2018…

…The outbreaks in Sudan and Yemen are the first new polio outbreaks in the COVID-19 era in our region. WHO’s Eastern Mediterranean Region is also responding to circulating vaccine-derived poliovirus outbreaks in Somalia, Afghanistan and Pakistan. We know that when national authorities, communities and polio programme partners pull together, we can end outbreaks – just as we did in Syria in 2018. But if we cannot reach every child across these regions with life-saving vaccine, we fear that even more countries will see children tragically and permanently paralysed by a disease that can – and must – be stopped…

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

Ebola – DRC+:: WHO/OCHA Emergencies

Emergencies

Ebola – DRC+
Last WHO Situation Report published 23 June 2020
Last WHO DON published 3 July 2020

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

WHO Grade 3 Emergencies [to 12 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 12 Sep 2020]
Iraq
:: WHO Iraq frontline workers tackling COVID-19 with community sensitizations and engagements WHO Iraq frontline workers tackling COVID-19 with community sensitizations and engagements 9 September 2020

Niger
:: L’Afrique certifiée libre du poliovirus sauvage : un évènement historique suivi au N…
07 septembre 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
Libya – No new digest announcements identified
Malawi Floods – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Mozambique – No new digest announcements identified
Myanmar – 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 12 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
:: Recent Developments in Northwest Syria – Situation Report No. 20 – As of 9 September 2020

Yemen
:: 09 September 2020 Yemen: COVID-19 Preparedness and Response Monthly Report (August 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.
COVID-19
:: Coronavirus disease 2019 (COVID-19) Situation Report 43: occupied Palestinian territory, issued 10 September 2020, information for period: 5 March – 10 September 2020

East Africa Locust Infestation
– No new digest announcements identified

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

WHO & Regional Offices [to 12 Sep 2020]

WHO & Regional Offices [to 12 Sep 2020]
10 September 2020
Statement
Statement from the first ACT-Accelerator Facilitation Council meeting
[See Milestones above for detail]

News release
Coronavirus Global Response: Access to COVID-19 Tools-Accelerator Facilitation Council holds inaugural meeting
:: United Nations Secretary General António Guterres appeals for a quantum leap in funding for the ACT-Accelerator, a global solution to get the world moving, working and prospering again
:: H.E. Cyril Ramaphosa, President of South Africa, and H.E. Erna Solberg, Prime Minister of Norway, co-chair the ACT-Acceleration Facilitation Council
:: Global leaders – including over 30 heads of state and ministers – release statement of commitment to galvanizing support for the ACT-Accelerator and the need for the financial resources required to leave no one behind
:: ACT-Accelerator calculates that $35 billion is still required to give all countries the tools needed to end the pandemic as quickly as possible

9 September 2020 News release
COVID-19 could reverse decades of progress toward eliminating preventable child deaths, agencies warn

9 September 2020 News release
More than 3 billion people protected from harmful trans fat in their food

8 September 2020 News release
WHO calls for global action on sepsis – cause of 1 in 5 deaths worldwide

::::::

Weekly Epidemiological Record, 11 September 2020, vol. 95, 37 (pp. 441–448)
Cholera 2019

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: COVID-19 genome sequencing laboratory network launches in Africa 10 September 2020
:: Noncommunicable diseases increase risk of dying from COVID-19 in Africa 10 September 2020

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
:: Digital health: transforming and extending the delivery of health services 09-09-2020
:: WHO Regional Director for Europe gives update on the work of the Regional Office ahead of virtual Regional Committee 09-09-2020
:: Health priorities for the European Region and COVID-19 in focus at WHO annual meeting 08-09-2020
:: A new international day to celebrate clean air – and a sustainable recovery from COVID-19 07-09-2020

WHO Eastern Mediterranean Region EMRO
:: WHO provides medical supplies to Sudan following major flooding 9 September 2020
:: UNICEF, WHO support Sudan’s efforts to end vaccine-derived polio outbreak 8 September 2020

WHO Western Pacific Region
No new digest content identified

Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 12 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 12 Sep 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

 

BMGF – Gates Foundation [to 12 Sep 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 12 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 12 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 12 Sep 2020]
http://cepi.net/
Latest News
No new digest content identified.

 

EDCTP [to 12 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 12 Sep 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 12 Sep 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
No new digest content identified.

 

European Vaccine Initiative [to 12 Sep 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 12 Sep 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
September 11, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 11, 2020
In a new FDA Voices entitled, The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health, agency leaders explain that they are committed to making decisions that are guided by science and data regarding the authorization or approval of COVID-19 vaccines.
… FDA issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,” to help drug and biological product manufacturers (including animal drug manufacturers) transition from operations impacted by the COVID-19 public health emergency to normal manufacturing operations.

September 10, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 10, 2020

September 9, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 9, 2020

September 8, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 8, 2020
…The FDA has deactivated the FDA registration for 340 foreign establishments that failed to identify a U.S. Agent as required by FDA’s regulations.  Of these, 131 establishments list devices that are essential to the COVID-19 pandemic response.
…Testing updates: To date, the FDA has currently authorized 243 tests under EUAs; these include 195 molecular tests, 44 antibody tests, and 4 antigen tests.

 

Fondation Merieux [to 12 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 12 Sep 2020]
https://www.gavi.org/
News releases
No new digest content identified.

 

GHIT Fund [to 12 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 12 Sep 2020]
https://www.theglobalfund.org/en/news/
News/Updates
COVID-19 Response: Corticosteroids
08 September 2020
Following the World Health Organization guidance Corticosteroids for COVID-19 from 2 September, the Global Fund has confirmed that corticosteroids can be funded through Global Fund grants.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 12 Sep 2020]
https://www.glopid-r.org/news/
News
Mérieux Foundation seeks Scientific and Advocacy Director for the GloPID-R Secretariat
01/09/2020
Since 2015, the GloPID-R alliance has been pursuing its objectives to increase preparedness and facilitate rapid research response to outbreaks…

 

Hilleman Laboratories [to 12 Sep 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 12 Sep 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Release
No new digest content identified.

 

IAVI [to 12 Sep 2020]
https://www.iavi.org/newsroom
FEATURES
September 8, 2020
IAVI Researchers Publish Study on Antibody Responses to HIV Immunogen in Non-human Primates
Researchers at IAVI’s Neutralizing Antibody Center (NAC), Scripps Research, and other partner organizations have identified and isolated a suite of neutralizing HIV antibodies that develop in rhesus macaques in response to immunization with BG505 SOSIP. This immunogen is the basis of several HIV vaccine candidates now in Phase I clinical trials, including the IAVI W001 trial. Their findings were published in Cell Reports on September 8, 2020…

 

 

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 12 Sep 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Europe, Greece
Residents of Moria camp must be moved now – Red Cross head
Around 13,000 people are lacking food, water and shelter, after devastating fires on Tuesday and Wednesday this week. At the time of the first fire the camp was under lockdown due to more than 30 COVID19 positive cases.
11 September 2020

Africa, Sudan
Red Cross launches Emergency Appeal for Sudan as deadly flooding leaves thousands homeless
Nairobi/Geneva, 11 September 2020 — The International Federation of Red Cross and Red Crescent Societies (IFRC) today launched an additional funds appeal for 12 million Swiss Francs to support the Sudanese Red Crescent Society (SRCS) in delivering assi …
11 September 2020

Global
Red Cross Red Crescent turns to Rakuten Viber to fight COVID-19 infodemic
Geneva, 10 September 2020 – The International Federation of Red Cross and Red Crescent Societies (IFRC) and the Croatian Red Cross today signed a new partnership agreement with global messaging app Rakuten Viber to engage new online audiences with trus …
10 September 2020

Global
Migrants and refugees “least protected, most affected” in COVID crisis, warns IFRC President
Geneva, 10 September 2020 – The COVID-19 pandemic has been a disaster for people from all walks of life, but an absolute “catastrophe” for the world’s vulnerable migrants, people seeking asylum and refugees. Already weak social safety nets are eroding, …
10 September 2020

Global
IFRC’s first ever virtual climate summit, Climate:Red, is happening everywhere on 9-10 September 
Geneva, 8 September 2020 – Climate:Red, a fully virtual and truly global climate change summit, is bringing youth champions, activists, indigenous leaders, scientists and government ministers together on 9 – 10 September 2020 for 30 hours of innovation …
8 September 2020

 

IRC International Rescue Committee [to 12 Sep 2020]
http://www.rescue.org/press-release-index
Media highlights {Selected]
Press Release
As the threat of resettlement postponement looms, IRC urges the Trump Administration to set refugee admissions cap to at least 95,000 by September 30
September 11, 2020

Press Release
International Rescue Committee’s Pakistan Reading Project Wins 2020 International Prize from the Library of Congress
September 10, 2020

Statement
New UN report details ongoing atrocities in Yemen; IRC calls for immediate ceasefire
September 10, 2020

Press Release
New Research Finds Lack of Access to Adequate Child Care As One of the Top Barriers to Economic Empowerment for Refugee Women
September 10, 2020

Press Release
Over 12,000 people left stranded in Lesvos after a fire engulfs Moria reception centre; IRC providing mental health support to survivors
September 9, 2020

 

IVAC [to 12 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 12 Sep 2020]
http://www.ivi.int/
Selected IVI News & Announcements
IVI to ready clinical trial sites for COVID-19 vaccine efficacy trials in 4 countries
September 9, 2020 – SEOUL, South Korea – The International Vaccine Institute (IVI) announced today that the Bill & Melinda Gates Foundation awarded close to 1.5 million USD to IVI to support clinical trial site preparedness in four African and Asian countries to potentially support future COVID-19 Phase III efficacy vaccine trials.
[See COVID-19 above for detail]

 

JEE Alliance [to 12 Sep 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 12 Sep 2020]
http://www.msf.org/
Latest [Selected Announcements]
Myanmar
MSF hands over long-running HIV project in Yangon to ministry of …
Project Update 10 Sep 2020

Greece
All people in Moria camp must be evacuated to safety in wake of destru…
Project Update 9 Sep 2020

Pakistan
Meeting regular health needs amid the COVID-19 pandemic in…
Project Update 8 Sep 2020

 

 

Nigeria
“Children can draw assault rifles better than a football” in Borno state
Interview 8 Sep 2020

 

National Vaccine Program Office – U.S. HHS [to 12 Sep 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC Meetings
September 23-24, 2020 Meeting (Virtual)
Selected Agenda Topics:
:: Serving Up Equity: Health-In-All Approaches for COVID-19 Vaccination [Panel]
:: Allocation and Prioritization: Considerations and Recommendations for the Distribution of
COVID-19 Vaccines [Dr. Ezekiel Emanuel, University of Pennsylvania; CDC tbd]
:: Perspectives from the Field: Operation Warp Speed [Dr. Moncef Slaoui, HHS]
:: The Infodemic, COVID-19 Immunization, and the Public’s Health [Panel]
:: Immunization Information Systems to Support the COVID-19 Response [Panel]

 

NIH [to 12 Sep 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH ACTIV initiative launches adaptive clinical trials of blood-clotting treatments for COVID-19
September 10, 2020
The National Institutes of Health has launched two of three adaptive Phase 3 clinical trials evaluating the safety and effectiveness of varying types of blood thinners to treat adults diagnosed with COVID-19. Part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, these trials will be conducted at more than 100 sites around the world and will involve patients in various clinical settings — those who have not been hospitalized, those currently hospitalized and those discharged after hospitalization for moderate to severe disease.
Collectively known as ACTIV-4 Antithrombotics, the trials will provide critical insights that could help guide the care of patients with COVID-19, particularly those who suffer from life-threatening blood clots. The trial for hospitalized COVID-19 patients and the trial for patients with COVID-19 who have not been hospitalized are now underway. A third trial to start later will focus on patients discharged after hospitalization for moderate to severe COVID-19 disease. All three clinical trials will be coordinated and overseen by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, and funded through Operation Warp Speed(link is external)

 

PATH [to 12 Sep 2020]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

 

Sabin Vaccine Institute [to 12 Sep 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 12 Sep 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
9 September 2020
Cash donations for people who use drugs during COVID-19 in Bangladesh

 

UNICEF [to 12 Sep 2020]
https://www.unicef.org/media/press-releases
Selected Press releases/Announcements
Statement
09/11/2020
UNICEF statement on children affected by the Moria camp fire on Lesvos Island, Greece

Statement
09/11/2020
Polio programme accelerates efforts to respond to new polio outbreaks in Sudan and Yemen
Joint statement by WHO Regional Director for the Eastern Mediterranean Region Dr Ahmed Al Mandhari and UNICEF Regional Director for the Middle East and North Africa Region Ted Chaiban

Statement
09/10/2020
UNICEF Executive Director Henrietta Fore’s remarks at the UN Security Council Open Debate on Children and Armed Conflict: Attacks against schools as a grave violation of children’s rights
This is a summary of what was said by Henrietta Fore, UNICEF Executive Director – to whom quoted text may be attributed – at today’s Security Council Open Debate at the United Nations in New York. Checked against delivery.

Press release
09/10/2020
The Time to Prepare for COVID-19 Vaccine Transport is Now
[See COVID-19 above for detail]

Statement
09/10/2020
Remarks by UNICEF Executive Director Henrietta Fore at the 2020 Executive Board Session

Press release
09/09/2020
More than half a million children under five in Burkina Faso are acutely malnourished – UNICEF

Statement
09/09/2020
UNICEF statement on fire at Moria Camp in Lesvos, Greece

Press release
09/08/2020
COVID-19 could reverse decades of progress toward eliminating preventable child deaths, agencies warn
With the number of under-five deaths at an all-time recorded low of 5.2 million in 2019, disruptions in child and maternal health services due to the COVID-19 pandemic are putting millions of additional lives at stake

 

Unitaid [to 12 Sep 2020]
https://unitaid.org/
Featured News
No new digest content identified.

 

Vaccination Acceptance Research Network (VARN) [to 12 Sep 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 12 Sep 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 12 Sep 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 12 Sep 2020]
https://wellcome.ac.uk/news
Explainer | 11 September 2020
Safety first: how to run a Covid-19 vaccine clinical trial
The world is waiting eagerly for Covid-19 vaccines to be developed as quickly as possible. But to make sure they are safe and effective, the clinical trials that test them have to be robust. So how do trials achieve this?

Opinion | 7 September 2020
The first Covid-19 vaccine may not be the magic bullet that returns life to ‘normal’
Jeremy Farrar
Director Wellcome
As we’ll soon start to see the results of the first vaccines coming through late-stage clinical trials, Jeremy Farrar explains why we should be cautiously optimistic.

 

The Wistar Institute [to 12 Sep 2020]
https://www.wistar.org/news/press-releases
Press Releases
Sep. 10, 2020
Scientists Engineer DNA-based Nanotechnology to Stimulate Potent Antitumor Immune Responses in Preclinical Models
Synthetic DNA nanovaccines enhance killer T cell immunity resulting in tumor control in preclinical studies.

Press Release
Sep. 7, 2020
The BEAT-HIV Martin Delaney Collaboratory Issues Recommendations on Measuring Persistent HIV Reservoirs in Cure-directed Clinical Trials
The consortium provides first authoritative viewpoint on which viral measurements to prioritize when evaluating the impact of potential therapeutic strategies to eradicate HIV.

 

WFPHA: World Federation of Public Health Associations [to 12 Sep 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.

 

World Organisation for Animal Health (OIE) [to 12 Sep 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

 

 

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ARM [Alliance for Regenerative Medicine] [to 12 Sep 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.

 

BIO [to 12 Sep 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 12 Sep 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 12 Sep 2020]
https://internationalbiotech.org/
News
No new digest content identified.

 

IFPMA [to 12 Sep 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
COVID-19 Vaccine Maker Pledge
08 September 2020
[See COVID-19 Vaccines above for detail]

 

PhRMA [to 12 Sep 2020]
http://www.phrma.org/
Selected Press Releases, Statements
PhRMA member companies invested $83 billion in research and development last year
Tim McClung   |     September 10, 2020   |
PhRMA member companies invested $83 billion in research and development (R&D) in 2019, the highest level of investment on record, according to the 2020 PhRMA member annual survey. Over the past two decades, PhRMA member companies have invested a grand total of nearly $1 trillion in the search for and development of new and better treatments and cures.
America’s biopharmaceutical companies are at the heart of a robust R&D ecosystem that develops more innovative medicines than any other country in the world. There are nearly 260 vaccines in development for the treatment or prevention of disease, including numerous different types of potential vaccines that target COVID-19…

Journal Watch

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

Human germline editing in the era of CRISPR-Cas: risk and uncertainty, inter-generational responsibility, therapeutic legitimacy

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 12 Sep 2020)

 

Debate Open Access
Human germline editing in the era of CRISPR-Cas: risk and uncertainty, inter-generational responsibility, therapeutic legitimacy
Authors: Sebastian Schleidgen, Hans-Georg Dederer, Susan Sgodda, Stefan Cravcisin, Luca Lüneburg, Tobias Cantz and Thomas Heinemann
11 September 2020
Abstract
Background
Clustered Regularly Interspaced Short Palindromic Repeats-associated (CRISPR-Cas) technology may allow for efficient and highly targeted gene editing in single-cell embryos. This possibility brings human germline editing into the focus of ethical and legal debates again.
Main body
Against this background, we explore essential ethical and legal questions of interventions into the human germline by means of CRISPR-Cas: How should issues of risk and uncertainty be handled? What responsibilities arise regarding future generations? Under which conditions can germline editing measures be therapeutically legitimized? For this purpose, we refer to a scenario anticipating potential further development in CRISPR-Cas technology implying improved accuracy and exclusion of germline transmission to future generations. We show that, if certain concepts regarding germline editing are clarified, under such conditions a categorical prohibition of one-generation germline editing of single-cell embryos appears not to be ethically or legally justifiable.
Conclusion
These findings are important prerequisites for the international debate on the ethical and legal justification of germline interventions in the human embryo as well as for the harmonization of international legal standards.

Preparing for a pandemic: highlighting themes for research funding and practice—perspectives from the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R)

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 12 Sep 2020)

 

Preparing for a pandemic: highlighting themes for research funding and practice—perspectives from the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R)
The Global Research Collaboration for Infectious Disease Preparedness (GloPID-R) is an international network of global health funders and stakeholders formed in 2013 to ensure preparedness for a coordinated research response to epidemics and pandemics [1]. GloPID-R aims to address challenges to effective research in epidemics and pandemics, through both preparedness and response activities.
Authors: Alice Norton, Louise Sigfrid, Adeniyi Aderoba, Naima Nasir, Peter G. Bannister, Shelui Collinson, James Lee, Geneviève Boily-Larouche, Josephine P. Golding, Evelyn Depoortere, Gail Carson, Barbara Kerstiëns and Yazdan Yazdanpanah
Citation: BMC Medicine 2020 18:273
Content type: Commentary
Published on: 8 September 2020

Targeted vaccination campaigns of teenagers after two clusters of B invasive meningococcal disease in Brittany, France, 2017

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 12 Sep 2020)

 

Targeted vaccination campaigns of teenagers after two clusters of B invasive meningococcal disease in Brittany, France, 2017
In December 2016, three cases of serogroup B invasive meningococcal disease, including two children from the same middle school (11 to 15 years old pupils), occurred in the department (administrative district)…
Authors: Mathilde Pivette, Muhamed-Kheir Taha, Anne-Sophie Barret, Elisabeth Polard, Marie-Bernadette Hautier, Jean-Benoît Dufour, Marlène Faisant, Lisa Antoinette King, Denise Antona, Daniel Levy-Bruhl, Hélène Tillaut, Alexandre Scanff, Camille Morival, José-Hector Aranda Grau, Pierre Guillaumot and Bertrand Gagnière
Citation: BMC Public Health 2020 20:1382
Content type: Research article
Published on: 10 September 2020

Impact of an influenza information pamphlet on vaccination uptake among Polish pupils in Edinburgh, Scotland and the role of social media in parental decision making

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 12 Sep 2020)

 

Impact of an influenza information pamphlet on vaccination uptake among Polish pupils in Edinburgh, Scotland and the role of social media in parental decision making
In Edinburgh, Scotland, lower influenza vaccine uptake has been observed in primary school children in the Polish community.
Authors: K. Bielecki, J. Craig, L. J. Willocks, K. G. Pollock and D. R. Gorman
Citation: BMC Public Health 2020 20:1381
Content type: Research article
Published on: 10 September 2020

Impact of quadrivalent influenza vaccines in Brazil: a cost-effectiveness analysis using an influenza transmission model

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 12 Sep 2020)

 

Impact of quadrivalent influenza vaccines in Brazil: a cost-effectiveness analysis using an influenza transmission model
Influenza epidemics significantly weight on the Brazilian healthcare system and its society. Public health authorities have progressively expanded recommendations for vaccination against influenza, particularl…
Authors: Pascal Crépey, Louis Boiron, Rafael Rodrigo Araujo, Juan Guillermo Lopez, Audrey Petitjean and Expedito José de Albuquerque Luna
Citation: BMC Public Health 2020 20:1374
Content type: Research article
Published on: 9 September 2020

Addressing COVID-19 in humanitarian settings: a call to action

Conflict and Health
http://www.conflictandhealth.com/
[Accessed 12 Sep 2020]

 

Addressing COVID-19 in humanitarian settings: a call to action
Authors: Jude Alawa, Nawara Alawa, Adam Coutts, Richard Sullivan, Kaveh Khoshnood and Fouad M. Fouad
Citation: Conflict and Health 2020 14:64
Content type: Commentary
Published on: 10 September 2020
Abstract
Refugees and internally displaced persons in humanitarian settings are particularly susceptible to the spread of infectious illnesses such as COVID-19 due to overcrowding and inadequate access to clean water, sanitation, and hygiene facilities. Countries facing conflict or humanitarian emergencies often have damaged or fragmented health systems and little to no capacity to test, isolate, and treat COVID-19 cases. Without a plan to address COVID-19 in humanitarian settings, host governments, aid agencies, and international organizations risk prolonging the spread of the virus across borders, threatening global health security, and devastating vulnerable populations. Stakeholders must coordinate a multifaceted response to address COVID-19 in humanitarian settings that incorporates appropriate communication of risks, sets forth resource-stratified guidelines for the use of limited testing, provides resources to treat affected patients, and engages displaced populations.

Disease burden metrics and the innovations of leading pharmaceutical companies: a global and regional comparative study

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

 

Articles
Disease burden metrics and the innovations of leading pharmaceutical companies: a global and regional comparative study
The recent innovation activities of global top-tier pharmaceutical companies in accordance with global and regional health concerns were investigated in order to identify their innovations contributing to popu…
Authors: Ye Lim Jung, JeeNa Hwang and Hyoung Sun Yoo
Citation: Globalization and Health 2020 16:80
Content type: Research
Published on: 10 September 2020

Restrictions On US Global Health Assistance Reduce Key Health Services In Supported Countries

Health Affairs
Vol. 39, No. 9 September 2020
https://www.healthaffairs.org/toc/hlthaff/current

 

Medicare Payment Incentives, Medicaid & More
Research Article Global Health Policy
Restrictions On US Global Health Assistance Reduce Key Health Services In Supported Countries
Jennifer Sherwood, Matthea Roemer, Brian Honermann, Austin Jones, Greg Millett, and Michele R. Decker

HPV vaccine status and sexual behavior among young sexually-active women in the US: evidence from the National Health and Nutrition Examination Survey, 2007–2014

Health Economics, Policy and Law 
Volume 15 – Issue 4 – October 2020
https://www.cambridge.org/core/journals/health-economics-policy-and-law/latest-issue

 

Article
HPV vaccine status and sexual behavior among young sexually-active women in the US: evidence from the National Health and Nutrition Examination Survey, 2007–2014
Andrew J. Leidner, Harrell W. Chesson, Makram Talih

Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes – Interim Analysis of 2 Randomized Clinical Trials

JAMA
September 8, 2020, Vol 324, No. 10, Pages 919-1016
https://jamanetwork.com/journals/jama/currentissue

 

Preliminary Communication
Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes – Interim Analysis of 2 Randomized Clinical Trials
Shengli Xia, BS; Kai Duan, PhD; Yuntao Zhang, PhD; et al.
free access has active quiz
JAMA. 2020;324(10):951-960. doi:10.1001/jama.2020.15543
This interim analysis of 2 randomized trials compares adverse reactions and neutralizing antibody responses to inactivated coronavirus disease 2019 (COVID-19) vs adjuvant-only control vaccination, and compares the outcomes at varying vaccine doses among healthy adults in China.
…Conclusions and Relevance  In this interim report of the phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing. Efficacy and longer-term adverse event assessment will require phase 3 trials.
Trial Registration  Chinese Clinical Trial Registry Identifier: ChiCTR2000031809

An Inactivated Virus Candidate Vaccine to Prevent COVID-19

JAMA
September 8, 2020, Vol 324, No. 10, Pages 919-1016
https://jamanetwork.com/journals/jama/currentissue

 

Editorial
An Inactivated Virus Candidate Vaccine to Prevent COVID-19
Mark J. Mulligan, MD
… In summary, this preliminary report by Xia et al10 provides important interim safety, tolerability, and immune response results for a β-propiolactone–inactivated whole-virus vaccine against COVID-19. These interim data are of interest given the urgent global need for protective COVID-19 vaccines. With 7.8 billion individuals worldwide at risk for SARS-CoV-2 infection and COVID-19 morbidity and mortality, humanity needs as many safe and protective COVID-19 vaccines as possible.

Unwavering Regulatory Safeguards for COVID-19 Vaccines

JAMA
September 8, 2020, Vol 324, No. 10, Pages 919-1016
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
Unwavering Regulatory Safeguards for COVID-19 Vaccines
Anand Shah, MD; Peter W. Marks, MD, PhD; Stephen M. Hahn, MD
free access has active quiz has multimedia has audio
JAMA. 2020;324(10):931-932. doi:10.1001/jama.2020.15725
This Viewpoint from the FDA reviews the minimum safety and efficacy standards COVID-19 vaccine candidates would need to meet to be considered for approval, and affirms its commitments to evaluating both in diverse populations and to postmarketing surveillance as means to ensure that approval will meet the highest safety and regulatory standards based on science and evidence, not politics.

Improving Physician Communication About Treatment Decisions – Reconsideration of “Risks vs Benefits”

JAMA
September 8, 2020, Vol 324, No. 10, Pages 919-1016
https://jamanetwork.com/journals/jama/currentissue

 

Improving Physician Communication About Treatment Decisions – Reconsideration of “Risks vs Benefits”
Daniel J. Morgan, MD; Laura D. Scherer, PhD; Deborah Korenstein, MD
has audio
JAMA. 2020;324(10):937-938. doi:10.1001/jama.2020.0354
This Viewpoint emphasizes the importance of precise language to help patients make evidence-informed decisions in shared decision-making, and argues that references to “chances of harms and benefits” will be more understandable to patients than discussions of “probabilities of risks and benefits.”
Conversations with Dr Bauchner: Changing Language to Improve Physician Communication About Treatment Decisions

Inclusion of Children in Clinical Trials of Treatments for Coronavirus Disease 2019 (COVID-19)

JAMA Pediatrics
September 2020, Vol 174, No. 9, Pages 815-916
http://archpedi.jamanetwork.com/issue.aspx

 

Viewpoint
Inclusion of Children in Clinical Trials of Treatments for Coronavirus Disease 2019 (COVID-19)
Thomas J. Hwang, AB; Adrienne G. Randolph, MD, MSc; Florence T. Bourgeois, MD, MPH
free access
JAMA Pediatr. 2020;174(9):825-826. doi:10.1001/jamapediatrics.2020.1888
This Viewpoint discusses the exclusion of children from coronavirus disease 2019 (COVID-19) clinical trials and why that could harm treatment options for children.

Incidence of Meningococcal Disease Before and After Implementation of Quadrivalent Meningococcal Conjugate Vaccine in the United States

JAMA Pediatrics
September 2020, Vol 174, No. 9, Pages 815-916
http://archpedi.jamanetwork.com/issue.aspx

 

Original Investigation
Incidence of Meningococcal Disease Before and After Implementation of Quadrivalent Meningococcal Conjugate Vaccine in the United States
Sarah Mbaeyi, MD, MPH; Tracy Pondo, MSPH; Amy Blain, MPH; et al.
JAMA Pediatr. 2020;174(9):843-851. doi:10.1001/jamapediatrics.2020.1990
This cohort study examines the association between quadrivalent meningococcal conjugate vaccination and the incidence of meningococcal disease in US adolescents.

Association Between Human Papillomavirus Vaccination School-Entry Requirements and Vaccination Initiation

JAMA Pediatrics
September 2020, Vol 174, No. 9, Pages 815-916
http://archpedi.jamanetwork.com/issue.aspx

 

Association Between Human Papillomavirus Vaccination School-Entry Requirements and Vaccination Initiation
Jamie S. Ko, MPH; Cameron S. Goldbeck, MS; Eleonore B. Baughan, BS; et al.
has active quiz
JAMA Pediatr. 2020;174(9):861-867. doi:10.1001/jamapediatrics.2020.1852
This cross-sectional study examines initiation of human papillomavirus vaccination in US jurisdictions with vs those without policies requiring vaccination for school entry.

A Scenario-Based Methodology for Analyzing the Ethical, Legal, and Social Issues in Genomic Data Sharing

Journal of Empirical Research on Human Research Ethics
Volume 15 Issue 4, October 2020
http://journals.sagepub.com/toc/jre/current

Empirical Studies on Research Integrity and Research Misconduct
A Scenario-Based Methodology for Analyzing the Ethical, Legal, and Social Issues in Genomic Data Sharing
Rebekah McWhirter, Lisa Eckstein, Don Chalmers, Christine Critchley, Jane Nielsen, Margaret Otlowski, Dianne Nicol
First Published May 19, 2020; pp. 355–364