Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK: a substudy of two randomised controlled trials (COV001 and COV002)

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The Lancet
Sep 11, 2021 Volume 398 Number 10304 p931-1020, e14
https://www.thelancet.com/journals/lancet/issue/current

 

Articles
Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK: a substudy of two randomised controlled trials (COV001 and COV002)
Amy Flaxman, et al. and the Oxford COVID Vaccine Trial group
Open Access

What are the obligations of pharmaceutical companies in a global health emergency?

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The Lancet
Sep 11, 2021 Volume 398 Number 10304 p931-1020, e14
https://www.thelancet.com/journals/lancet/issue/current

 

Viewpoint
What are the obligations of pharmaceutical companies in a global health emergency?
Ezekiel J Emanuel, et al.
Introduction
During a global health emergency, everyone is morally required to help to combat the disease. With approximately 8000–10 000 people dying every day from COVID-19, as of writing, only rapid and globally distributed vaccinations will end the pandemic. With the support of national governments, pharmaceutical companies have produced more than 250 vaccine candidates to date.
WHO, the Coalition for Epidemic Preparedness Innovations, and Gavi, the Vaccine Alliance have established COVID-19 Vaccines Global Access (COVAX) to procure and fairly distribute vaccines.1
But much vaccine development, production, procurement, and distribution is ad hoc, generating controversy and inconsistency. Pharmaceutical companies have been criticised for knowledge hoarding, secret pricing, unreasonable profits, unfair bilateral deals, and extortionate demands for indemnification against liability.2, 3 COVAX has been criticised for an absence of transparency and accountability and for ignoring need in COVID-19 vaccine distribution.4, 5, 6, 7 All parties involved in researching, developing, manufacturing, and distributing COVID-19 vaccines need guidance on their ethical obligations. We focus on pharmaceutical companies’ obligations because their capacities to research, develop, manufacture, and distribute vaccines make them uniquely placed for stemming the pandemic…

A roadmap for the Human Developmental Cell Atlas

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Nature
Volume 597 Issue 7875, 9 September 2021
https://www.nature.com/nature/volumes/597/issues/7875

 

Perspective | 08 September 2021
A roadmap for the Human Developmental Cell Atlas
This Perspective outlines the Human Developmental Cell Atlas initiative, which uses state-of-the-art technologies to map and model hum-an development across gestation, and discusses the early milestones that have been achieved.
Muzlifah Haniffa, Deanne Taylor, Matthias Zilbauer

Economic Evidence on Potentially Curative Gene Therapy Products: A Systematic Literature Review

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PharmacoEconomics
Volume 39, issue 9, September 2021
https://link.springer.com/journal/40273/volumes-and-issues/39-9

 

Articles
Economic Evidence on Potentially Curative Gene Therapy Products: A Systematic Literature Review
Authors (first, second and last of 8)Joseph Khoa Ho, Kennedy Borle, Larry D. Lynd
Content type: Systematic Review
Published: 22 June 2021
Pages: 995 – 1019

A Net Benefit Approach for the Optimal Allocation of a COVID-19 Vaccine

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PharmacoEconomics
Volume 39, issue 9, September 2021
https://link.springer.com/journal/40273/volumes-and-issues/39-9

 

A Net Benefit Approach for the Optimal Allocation of a COVID-19 Vaccine
Authors (first, second and last of 5) Erin Kirwin, Ellen Rafferty, Christopher McCabe
Content type: Original Research Article
Open Access
Published: 17 June 2021
Pages: 1059 – 1073

Empowering grassroots innovation to accelerate biomedical research

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PLoS Biology
August 2021
https://journals.plos.org/plosbiology/issue

 

Perspectives
Empowering grassroots innovation to accelerate biomedical research
Bastian Greshake Tzovaras, Michael Rera, Edwin H. Wintermute, Katharina Kloppenborg, Juliette Ferry-Danini, Guy Aidelberg, Rachel Aronoff, Ariel Lindner, Dusan Misevic
PLOS Biology: published August 9, 2021 | https://doi.org/10.1371/journal.pbio.3001349

Optimized delay of the second COVID-19 vaccine dose reduces ICU admissions

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PNAS – Proceedings of the National Academy of Sciences of the United States of America
August 31, 2021; vol. 118 no. 35
https://www.pnas.org/content/118/35

 

Physical Sciences
Applied Mathematics
Open Access
Optimized delay of the second COVID-19 vaccine dose reduces ICU admissions
Paulo J. S. Silva, Claudia Sagastizábal, Luís Gustavo Nonato, Claudio José Struchiner, and Tiago Pereira
PNAS August 31, 2021 118 (35) e2104640118; https://doi.org/10.1073/pnas.2104640118

Process evaluation of complex interventions in chronic and neglected tropical diseases in low- and middle-income countries—a scoping review protocol

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Systematic Reviews
https://systematicreviewsjournal.biomedcentral.com/articles
[Accessed 11 Sep 2021]

 

Process evaluation of complex interventions in chronic and neglected tropical diseases in low- and middle-income countries—a scoping review protocol
The use of process evaluations is a growing area of interest in research groups working on complex interventions. This methodology tries to understand how the intervention was implemented to inform policy and …
Authors: María Lazo-Porras, Hueiming Liu, J. Jaime Miranda, Graham Moore, Mafalda Burri, François Chappuis, Pablo Perel and David Beran
Citation: Systematic Reviews 2021 10:244
Content type: Protocol
Published on: 7 September 2021

A protocol for a systematic literature review of economic evaluation studies of interventions to address antimicrobial resistance

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Systematic Reviews
https://systematicreviewsjournal.biomedcentral.com/articles
[Accessed 11 Sep 2021]

 

A protocol for a systematic literature review of economic evaluation studies of interventions to address antimicrobial resistance
Antimicrobial resistance (AMR) is accelerated by the widespread and often indiscriminate use of antimicrobials in humans, animals, and the environment. In 2015, the World Health Organization recognised AMR as …
Authors: Aparna Ananthakrishnan, Chris Painter and Yot Teerawattananon
Citation: Systematic Reviews 2021 10:242
Content type: Protocol
Published on: 7 September 2021

Playing vaccine roulette: Why the current strategy of staking everything on Covid-19 vaccines is a high-stakes wager

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Vaccine
Volume 39, Issue 35 Pages 4921-5074 (16 August 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/35

 

Discussion Full text access
Playing vaccine roulette: Why the current strategy of staking everything on Covid-19 vaccines is a high-stakes wager
Elisabeth Paul, Garrett W. Brown, Andreas Kalk, Valéry Ridde
Pages 4921-4924

Racial disparities in influenza immunization during pregnancy in the United States: A narrative review of the evidence for disparities and potential interventions

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Vaccine
Volume 39, Issue 35 Pages 4921-5074 (16 August 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/35

 

Review article Abstract only
Racial disparities in influenza immunization during pregnancy in the United States: A narrative review of the evidence for disparities and potential interventions
Alice G. Callahan, Victoria H. Coleman-Cowger, Jay Schulkin, Michael L. Power
Pages 4938-4948

Does support to Private Health Practitioners increase childhood vaccination coverage? Findings from a comparative study in Afghanistan

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Vaccine
Volume 39, Issue 35 Pages 4921-5074 (16 August 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/35

 

Research article Open access
Does support to Private Health Practitioners increase childhood vaccination coverage? Findings from a comparative study in Afghanistan
Martijn Vink, Nawaraj Upadhaya, Hazrat Amin Amin, Mohammad Gul Liwal, … Maarten Schim van der Loeff
Pages 5007-5014

Cost of vaccine delivery strategies in low- and middle-income countries during the COVID-19 pandemic

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Vaccine
Volume 39, Issue 35 Pages 4921-5074 (16 August 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/35

 

Research article Open access
Cost of vaccine delivery strategies in low- and middle-income countries during the COVID-19 pandemic
Christina Banks, Allison Portnoy, Flavia Moi, Laura Boonstoppel, … Stephen C. Resch
Pages 5046-5054

Differential Effect of Vaccine Effectiveness and Safety on COVID-19 Vaccine Acceptance across Socioeconomic Groups in an International Sample

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Vaccines
https://www.mdpi.com/journal/vaccines

 

Open Access Article
Differential Effect of Vaccine Effectiveness and Safety on COVID-19 Vaccine Acceptance across Socioeconomic Groups in an International Sample
by Stefania Kerekes et al
Vaccines 2021, 9(9), 1010; https://doi.org/10.3390/vaccines9091010 (registering DOI) – 11 Sep 2021
Abstract
Controlling the spread of SARS-CoV-2 will require high vaccination coverage, but acceptance of the vaccine could be impacted by perceptions of vaccine safety and effectiveness. The aim of this study was to characterize how vaccine safety and effectiveness impact acceptance of a vaccine, […]

How do intergovernmental organizations embed themselves in global value chains: A case study of Gavi

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International Entrepreneurship Review
2021, 7(3), 7-21.
https://doi.org/10.15678/IER.2021.0703.01 Open Access
How do intergovernmental organizations embed themselves in global value chains: A case study of Gavi
Melodena Stephens, Immanuel Azaad Moonesar
Abstract
Objective: The article’s objective is to understand how non-MNE actors in the global arena, like intergovernmental organizations (IGOs) embed themselves in the global value chain by using their strong ties to states.
Research Design & Methods: For this study, a qualitative methodology approach investigates an underexplored area of research using a single case study, GAVI, that utilizes thick data.
Findings: The paper contributes to our understanding of IGOs and how they internationalize. New motives are identified, and the concept of soft power has been extended to IGOs.
Implications & Recommendations: IGOs in the humanitarian or developmental sector use soft power strategies to embed themselves in the global value chain. The paper’s implications are for policymakers and practitioners in the third sector, including those who invested interest at state-represented foreign direct investment. Future studies can look at how networks are leveraged, spillover occurs from a personal level to an institutional level, and vice-versa combining diplomacy, bargaining, and legitimacy.
Contribution & Value Added: The study highlights new areas of research like that of soft power. The current internationalization models of SMEs and MNEs may not neatly fit in the context of IGOs (which are born global). We reiterate that existing IB theories need to be applied to other state actors like sovereign wealth funds and non-governmental organizations.

medRxiv

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medRxiv
medRxiv is a free online archive and distribution server for complete but unpublished manuscripts (preprints) in the medical, clinical, and related health sciences. Preprints are preliminary reports of work that have not been certified by peer review. They should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information. medRxiv is for the distribution of preprints – complete but unpublished manuscripts – that describe human health research conducted, analyzed, and interpreted according to scientific principles…
https://www.medrxiv.org/content/about-medrxiv
[Accessed 11 Sep 2021]

Selected Content
Relative burdens of the COVID-19, malaria, tuberculosis and HIV/AIDS epidemics in sub-Saharan Africa
David Bell, Kristian Schultz Hansen
medRxiv 2021.03.27.21254483; doi: https://doi.org/10.1101/2021.03.27.21254483

COVID-19 Vaccine Concerns about Safety, Effectiveness and Policies in the United States, Canada, Sweden, and Italy among Unvaccinated Individuals
Rachael Piltch-Loeb, Nigel Harriman, Julia Healey, Marco Bonetti, Veronica Toffolutti, Marcia Testa, Max Su, Elena Savoia
medRxiv 2021.09.09.21263328; doi: https://doi.org/10.1101/2021.09.09.21263328

Determinants and trends of COVID-19 vaccine hesitancy and vaccine uptake in a national cohort of U.S. adults: a longitudinal cohort study
Madhura S Rane, Shivani Kochhar, Emily Poehlein, William You, McKaylee M Robertson, Rebecca Zimba, Drew A. Westmoreland, Matthew L Romo, Sarah G. Kulkarni, Mindy Chang, Amanda Berry, Angela M. Parcesepe, Andrew R. Maroko, Christian Grov, Denis Nash
medRxiv 2021.05.12.21257116; doi: https://doi.org/10.1101/2021.05.12.21257116

Think Tanks et al

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Think Tanks et al
 
 
Brookings [to 11 Sep 2021]
http://www.brookings.edu/
Upcoming Event
Accelerating COVID-19 vaccinations in Africa
11:00 AM – 12:00 PM EDT Sep 15

Op-Ed
Africa must produce its own vaccines
Landry Signé
Friday, September 10, 2021
 
 
Center for Global Development [to 11 Sep 2021]
http://www.cgdev.org/page/press-center
Accessed 11 Sep 2021
Before Recommending the RTS,S Malaria Vaccine for Wider Use, WHO Should Address Three Key Considerations
September 8, 2021
Last month, the world woke up to promising news on malaria prevention: administering an existing malaria vaccine (RTS,S) in addition to antimalarial drugs before the rainy season reduced child hospitalizations and deaths by approximately 70 percent in Burkina Faso and Mali. These results arrived ahead of a forthcoming decision from the World Health Organization on whether to recommend RTS,S for broader use. This blog argues that WHO should consider value for money and address three key considerations before making their reccomendation.
Javier Guzman et al.
 
 
Chatham House [to 11 Sep 2021]
https://www.chathamhouse.org/
Accessed 11 Sep 2021
[No new digest content identified]

 
 

CSIS
https://www.csis.org/
Accessed 11 Sep 2021
August 27, 2021 News Release
[No new digest content identified]

 
 

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
August 27, 2021 News Release
[No new digest content identified]
 
 
Urban Institute [to 11 Sep 2021]
https://www.urban.org/publications
Publications
[No new digest content identified]

Vaccines and Global Health: The Week in Review :: 4 September 2021

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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: 

vaccines-and-global-health_the-week-in-review_4-sep-2021Download

– 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

COVID

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Milestones :: Perspectives :: Research

 

COVID

 

Editor’s Note:
As is obvious to all, the sheer volume of strategic announcements, regulatory actions, country program decisions, commentary, and, indeed, misinformation around COVID response continues at extraordinary levels. Our weekly digest strives to present a coherent and comprehensive snapshot, but cannot be exhaustive, If you recognize a missed strategic development, a new source of rigorous analysis, or an insight/commentary that would benefit our common understanding, please advise me…we will review all suggestions and consider for inclusion in a subsequent edition: david.r.curry@ge2p2global.org

We are seeking access to modelling which engages scenarios and articulates imperatives around a pandemic end-game through at least a 2025 horizon. We assess that WHO must be conducting or contracting for such modeling – or should recognize an imperative to be doing so in its global health governance role. If we have missed such modeling in progress, we would be delighted to be advised of it and will include it in our coverage.

COVID Vaccines – OCHA:: HDX

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Milestones :: Perspectives :: Research

 

COVID Vaccines – OCHA:: HDX

COVID-19 Data Explorer: Global Humanitarian Operations
COVID-19 Vaccine Roll-out
Sep 04, 2021 | COVAX (WHO,GAVI,CEPI), UNDESA, Press Reports | DATA
Global COVID-19 Figures: 219M total confirmed cases; 4.5M total confirmed deaths
Global vaccines administered: 5.44B
Number of Countries: 29 [26]
COVAX Allocations Round 4-6 (Number of Doses): 120M
COVAX Delivered (Number of Doses): 74M [68M week ago]
Other Delivered (Number of Doses): 110M [98M week ago]
Total Delivered (Number of Doses): 180M [170M week ago]
Total Administered (Number of Doses): 160M [140M week ago]

 

::::::

Multilateral Leaders Task Force on COVID-19 [IMF, World Bank Group, WHO, WTO]
A joint initiative from the International Monetary Fund, World Bank Group, World Health Organization, and World Trade Organization to accelerate access to COVID-19 vaccines, therapeutics and diagnostics by leveraging multilateral finance and trade solutions, particularly in low- and middle-income countries.
Website accessed 04 Sep 2021: https://data.covid19taskforce.com/data The global view below is complemented by country-specific dashboards here.

World Bank Vaccine Operations Portal

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Milestones :: Perspectives :: Research

 

World Bank Vaccine Operations Portal
https://www.worldbank.org/en/who-we-are/news/coronavirus-covid19/world-bank-support-for-country-access-to-covid-19-vaccines
As of July 29, 2021, the World Bank approved operations to support vaccine rollout in 54 countries amounting to $4.6 billion. See the latest project financing, project documents and procurement information in the list below:

Countries receiving World Bank support for vaccines
As of July 29, 2021
This list of countries, project documents, and procurement notices and contracts will be updated as data becomes available.

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

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Milestones :: Perspectives :: Research

::::::

 

Coronavirus [COVID-19] – WHO
Public Health Emergency of International Concern (PHEIC)
https://www.who.int/emergencies/diseases/novel-coronavirus-2019

 

Weekly Epidemiological and Operational updates
Last update: 3 Sep 2021
Confirmed cases :: 218 946 836 [214 468 601 week ago]
Confirmed deaths :: 4 539 723 [4 470 969 week ago]
Vaccine doses administered: 5 289 724 918 [4 953 887 422 week ago]

WHO, Germany open Hub for Pandemic and Epidemic Intelligence in Berlin

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Milestones :: Perspectives :: Research

 

WHO, Germany open Hub for Pandemic and Epidemic Intelligence in Berlin
New hub’s mission is to provide the world with better data, analytics and decisions to detect and respond to health emergencies
1 September 2021 News release Berlin
To better prepare and protect the world from global disease threats, H.E. German Federal Chancellor Dr Angela Merkel and Dr Tedros Adhanom Ghebreyesus, World Health Organization Director-General, will today inaugurate the new WHO Hub for Pandemic and Epidemic Intelligence, based in Berlin.

“The world needs to be able to detect new events with pandemic potential and to monitor disease control measures on a real-time basis to create effective pandemic and epidemic risk management,” said Dr Tedros. “This Hub will be key to that effort, leveraging innovations in data science for public health surveillance and response, and creating systems whereby we can share and expand expertise in this area globally.”

 

The WHO Hub, which is receiving an initial investment of US$ 100 million from the Federal Republic of Germany, will harness broad and diverse partnerships across many professional disciplines, and the latest technology, to link the data, tools and communities of practice so that actionable data and intelligence are shared for the common good.

The  WHO Hub is part of WHO’s Health Emergencies Programme and will be a new collaboration of countries and partners worldwide, driving innovations to increase availability of key data; develop state of the art analytic tools and predictive models for risk analysis; and link communities of practice around the world. Critically, the WHO Hub will support the work of public health experts and policy-makers in all countries with the tools needed to forecast, detect and assess epidemic and pandemic risks so they can take rapid decisions to prevent and respond to future public health emergencies.

“Despite decades of investment, COVID-19 has revealed the great gaps that exist in the world’s ability to forecast, detect, assess and respond to outbreaks that threaten people worldwide,” said Dr Michael Ryan, Executive Director of WHO’s Health Emergency Programme. “The WHO Hub for Pandemic and Epidemic Intelligence is designed to develop the data access, analytic tools and communities of practice to fill these very gaps, promote collaboration and sharing, and protect the world from such crises in the future.”

 

The Hub will work to:
Enhance methods for access to multiple data sources vital to generating signals and insights on disease emergence, evolution and impact;
Develop state of the art tools to process, analyze and model data for detection, assessment and response;
Provide WHO, our Member States, and partners with these tools to underpin better, faster decisions on how to address outbreak signals and events; and
Connect and catalyze institutions and networks developing disease outbreak solutions for the present and future.

Dr Chikwe Ihekweazu, currently Director-General of the Nigeria Centre for Disease Control, has been appointed to lead the WHO Hub. WHO would like to acknowledge the Nigerian government for its support, which ensures strong leadership for this important initiative…

 

::::::

3 September 2021 Remarks
Director-General’s opening remarks at Building Resilience Through Innovation in Response to the COVID-19 Pandemic in LDCs Islamic Development Bank

1 September 2021 Remarks
Dr Michael Ryan’s remarks at the launch of the WHO Hub for Pandemic and Epidemic Intelligence

1 September 2021 Remarks
Director-General’s opening remarks at the Memorandum of Understanding with the Robert Koch Institute

1 September 2021 Remarks
Director-General’s remarks at the inauguration of the WHO Hub for Pandemic and Epidemic Intelligence

 

::::::

31 August 2021
WHO compendium of innovative health technologies for low-resource settings 2021. COVID-19
Objectives
The response to the global COVID-19 pandemic crisis has exacerbated the need for rapid evidence-based assessments of innovative health technologies to ensure safe and appropriate use. Thus, the
objectives of the 2021 compendium are to:
1. Select innovative technologies that can have an immediate or future impact on the COVID-19
preparedness and response, have the potential to improve health outcomes and quality of
life, and/or offer a solution to an unmet medical/health technology need by evaluating their
appropriateness, quality, and safety.
2. Shed light on advantages and challenges associated with the adoption of innovative health
technologies in low-resource settings.
3. Acknowledge some success stories and, at the same time, raise awareness of the pressing need for appropriate and affordable design solutions and encourage more innovative efforts in the field.
4. Encourage greater interaction among the ministries of health, procurement officers, donors,
technology developers, manufacturers, clinicians, academics and the general public to ensure
greater investment in appropriate health technology and a move toward universal access to
essential health technologies.
5. Support informed procurement decisions by NGOs, governments, and other stakeholders.

 

::::::
Weekly operational update on COVID-19 – 30 August 2021
Overview
In this edition of the COVID-19 Weekly Operational Update, highlights of country-level actions and WHO support to countries include:
GeneXpert machine donated to Belize’s Central Medical Laboratory
Supporting quality management implementation, coordination and costing as part of the COVID-19 laboratory response in Kyrgyzstan
15 000 kg of medical supplies arrive in Fiji to support the response to a surge in COVID-19 cases
Extending COVID-19 vaccination to Rohingya refugees in Cox’s Bazar camps in Bangladesh
Responding to COVID-19 in Jordan: The Innovative Use of Online Platforms
The Elsje Finck-Sanichar College COVAB in Suriname embraces OpenWHO and online learning during COVID-19 pandemic
Progress on a subset of indicators from the SPRP 2021 Monitoring and Evaluation Framework
Updates on WHO’s financing to support countries in SPRP 2021 implementation and provision of critical supplies.

 

Weekly epidemiological update on COVID-19 – 31 August 2021
Overview
With just under 4.4 million new cases reported this week (23-29 August), the number of new cases reported globally remains similar to the previous week after increasing for nearly two months (since mid-June). In the past week all regions reported either a decline (Africa, Americas) or a similar trend (Europe, South-East Asia, Eastern Mediterranean) in new cases, except for the Western Pacific Region which reported a 7% increase as compared to previous week. The number of deaths reported globally this week were also similar to last week, with just over 67 000 new deaths reported. The Eastern Mediterranean and Western Pacific Regions reported an increase in the number of weekly deaths, 9% and 16% respectively, while the South-East Asia Region reported the largest decrease (20%). The cumulative number of cases reported globally is now nearly 216 million and the cumulative number of deaths is just under 4.5 million.

In this edition, a special focus update is provided on:
SARS-CoV-2 Variants of Concern (VOCs) Alpha, Beta, Gamma and Delta which includes updates on the geographic distribution of these VOCs as well as a description of a newly classified Variant of Interest (VOI), Mu.

“…Based on the latest round of assessments, B.1.621 was classified as a VOI on 30 August 2021 and given the WHO label “Mu”. This includes the descendent Pango lineage B.1.621.1. This variant is known as 21H in Nextstrain nomenclature. The Mu variant has a constellation of mutations that indicate potential properties of immune escape. Preliminary data presented to the Virus Evolution Working Group show a reduction in neutralization capacity of convalescent and vaccinee sera similar to that seen for the Beta variant, but this needs to be confirmed by further studies.
Since its first identification in Colombia in January 2021, there have been a few sporadic reports of cases of the Mu variant and some larger outbreaks have been reported from other countries in South America and in Europe. As of 29 August, over 4500 sequences (3794 sequences of B.1.621 and 856 sequences of B.1.621.1) have been uploaded to GISAID from 39 countries. Although the global prevalence of the Mu variant among sequenced cases has declined and is currently below 0.1%, the prevalence in Colombia (39%) and Ecuador (13%) has consistently increased….”

Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 19 August 2021

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Milestones :: Perspectives :: Research

 

Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 19 August 2021
For 22 vaccine candidates, presents Manufacturer, Name of Vaccine, NRA of Record, Platform, EOI Accepted Status, Pre-submission Meeting Held Status, Dossier Accepted for Review, Status of Assessment; Anticipated/Completed Decision Date
[No updates since 19 Aug 2021]
::::::

 

COVID Vaccine Developer/Manufacturer Announcements
[relevant press releases/announcement from organizations from WHO EUL/PQ listing above]

 

AstraZeneca
Press Releases
AstraZeneca and European Commission reach settlement agreement over vaccine supply, ending litigation
03 September 2021
AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the Advance Purchase Agreement for the delivery of the COVID-19 vaccine Vaxzevria (ChAdOx1-S [Recombinant]).
Under the agreement, AstraZeneca commits to deliver 60 million doses of the vaccine by the end of the third quarter 2021, 75 million by the end of the fourth quarter 2021 and 65 million by the end of the first quarter 2022. Member States will be provided with regular delivery schedules, and capped rebates will apply in the event of any delayed doses…

BioCubaFarma – Cuba
Últimas Noticias – [Website not responding at inquiry; receiving 403-Forbidden]

 

CanSinoBIO
News – [Website not responding at inquiry]

Clover Biopharmaceuticals – China
News – No new digest announcements identified

 

Curevac [Bayer Ag – Germany]
News
CureVac’s CVnCoV Phase 2b/3 Study Data Published in Preprints with The Lancet
TÜBINGEN, Germany / BOSTON, USA – August 31, 2021
CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced the publication of its pivotal Phase 2b/3 (HERALD study) primary data of CVnCoV, its first-generation COVID-19 vaccine candidate, in Preprints with The Lancet. The HERALD study enrolled approximately 40,000 participants in ten countries across Latin America and Europe, in the predefined age groups 18 to 60 and above 60. For the final analysis, COVID-19 cases were caused by 15 different virus variants…

 

Gamaleya National Center
Latest News and Events – No new digest announcements identified [See Russia/RFID below]

IMBCAMS, China
Home – – [Website not responding at inquiry; receiving 502 Bad Gateway]

 

Janssen/JNJ
Press Releases
Aug 31, 2021 United States
Johnson & Johnson and Global Partners Announce Results from Phase 2b Imbokodo HIV Vaccine Clinical Trial in Young Women in Sub-Saharan Africa
:: Investigational vaccine candidate did not provide sufficient protection against HIV infection
:: No vaccine-related safety signals identified
:: J&J HIV vaccine program continues with global Phase 3 Mosaico HIV study evaluating a different composition of the vaccine regimen in different populations

 

Moderna
Press Releases
September 3, 2021
Moderna Announces Submission of Data to European Medicines Agency for its COVID-19 Vaccine Booster
mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against the Delta variant (B.1.617.2)

September 1, 2021
Moderna Announces Submission of Initial Data to U.S. FDA for Its COVID-19 Vaccine Booster
mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against the Delta variant (B.1.617.2)

 

Novavax
Press Releases – No new digest announcements identified
Novavax Statement on CDC Guidance Update for COVID-19 Clinical Trial Participants
Aug 30. 2021
…the U.S. Centers for Disease Control and Prevention (CDC) has provided updated guidance for those who have been vaccinated as part of a clinical trial in the U.S. The CDC guidance states that participants in the Novavax PREVENT-19 Phase 3 clinical trial meet the criteria to be considered fully vaccinated two weeks after they have completed the vaccine series…

 

Pfizer
Recent Press Releases
09.02.2021
Pfizer Announces Start of Phase 3 Clinical Trial in Adults for Its Investigational Vaccine Against Respiratory Syncytial Virus (RSV)
First subjects vaccinated in study of Pfizer’s RSV bivalent prefusion F subunit investigational vaccine candidate in adults ages 60 or older
RSV is a common and pervasive cause of severe acute respiratory illness in older adults with no vaccine currently available

 

Sanofi Pasteur
Press Releases – No new digest announcements identified

 

Serum Institute of India
NEWS & ANNOUNCEMENTS – No new digest announcements identified

 

Sinopharm/WIBPBIBP
News – [Website not responding at inquiry]

 

Sinovac
Press Releases – No new digest announcements identified

 

Vector State Research Centre of Viralogy and Biotechnology
Home – No new digest announcements identified

Zhifei Longcom, China
[Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.]
[No website identified]

 

::::::

GSK
Press releases for media
31 August 2021
SK bioscience and GSK start Phase 3 trial of adjuvanted COVID-19 vaccine candidate
:: Advance to Phase 3 follows positive interim Phase 1/2 immunogenicity and safety data
:: Global clinical trial will evaluate vaccine candidate GBP510 against the AZ/Oxford COVID-19 vaccine
:: Aim is for global supply through the COVAX facility in the first half of 2022, subject to data and regulatory review

 

SK Biosciences
Press releases – No new digest announcements identified

The Race for Global COVID-19 Vaccine Equity

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Milestones :: Perspectives :: Research

 

Duke – Launch and Scale Speedometer

The Race for Global COVID-19 Vaccine Equity
A flurry of nearly 200 COVID-19 vaccine candidates are moving forward through the development and clinical trials processes at unprecedented speed; more than ten candidates are already in Phase 3 large-scale trials and several have received emergency or limited authorization. Our team has aggregated and analyzed publicly available data to track the flow of procurement and manufacturing and better understand global equity challenges. We developed a data framework of relevant variables and conducted desk research of publicly available information to identify COVID vaccine candidates and status, deals and ongoing negotiations for procurement and manufacturing, COVID burden by country, and allocation and distribution plans. We have also conducted interviews with public officials in key countries to better understand the context and challenges facing vaccine allocation and distribution
[accessed 24 July 2021]
See our COVID Vaccine Purchases research
See our COVID Vaccine Manufacturing research
See our COVID Vaccine Donations & Exports research

Global Dashboard on COVID-19 Vaccine Equity

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Milestones :: Perspectives :: Research

 

Global Dashboard on COVID-19 Vaccine Equity
The Dashboard is a joint initiative of UNDP, WHO and the University of Oxford with cooperation across the UN system, anchored in the SDG 3 Global Action Plan for Healthy Lives and Well-being for All.

Dashboard on Vaccine Equity [accessed 04 Sep 2021]: https://data.undp.org/vaccine-equity/
See also visualization on Vaccine Access and Vaccine Affordability

Coronavirus (COVID-19) Vaccinations [Accessed 04 Sep 2021]

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Milestones :: Perspectives :: Research

 

Our World in Data
Coronavirus (COVID-19) Vaccinations [Accessed 04 Sep 2021]
40.2% of the world population has received at least one dose of a COVID-19 vaccine.
5.44 billion doses have been administered globally, and 35.64 million are now administered each day.
Only 1.8% of people in low-income countries have received at least one dose.

U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

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Milestones :: Perspectives :: Research

 

U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

CDC Statement Following ACIP Pfizer-BioNTech Vote
Monday, August 30, 2021
Today, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for use of the Pfizer-BioNTech’s licensed vaccine for people 16 and older.
This recommendation follows FDA’s decision to fully approve Pfizer’s COVID-19 vaccine.
The ACIP recommendation comes 9 months after the committee’s interim recommendation and after an exhaustive review of the scientific evidence demonstrating safety and effectiveness, and supporting continued use of the vaccine.
“We now have a fully approved COVID-19 vaccine and ACIP has added its recommendation. If you have been waiting for this approval before getting the vaccine, now is the time to get vaccinated and join the more than 173 million Americans who are already fully vaccinated,” said CDC Director Dr. Rochelle Walensky.

 

::::::

Vaccines and Related Biological Products Advisory Committee– FDA

:: Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement
Agenda
…The committee will meet in open session to discuss the Pfizer-BioNTech supplemental Biologics License Application for COMIRNATY for administration of a third dose, or “booster” dose, of the COVID-19 vaccine, in individuals 16 years of age and older. Under Topic I, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). Also, on September 30, 2021, under Topic II, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season. Under Topic I, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). Also, on September 30, 2021, under Topic II, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season. Under Topic I, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). Also, on September 30, 2021, under Topic II, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season.

:: Vaccines and Related Biological Products Advisory Committee September 30, 2021 Meeting Announcement – 09/30/2021 – 09/30/2021
Agenda
…Under Topic I, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). Also, on September 30, 2021, under Topic II, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season..

 

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White House [U.S.]
Briefing Room – Selected Major COVID Announcements
On-the-Record Press Call by Office of Science and Technology Policy Director Dr. Eric Lander and NSC Director for Global Health Security and Biodefense Dr. Beth Cameron on American Pandemic Preparedness
September 03, 2021 • Press Briefings

FACT SHEET: Biden Administration to Transform Capabilities for Pandemic Preparedness
September 03, 2021 • Statements and Releases

Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials
September 02, 2021 • Press Briefings

Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials
August 31, 2021 • Press Briefings

Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

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Milestones :: Perspectives :: Research

 

Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

 

European Medicines Agency
News & Press Releases
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
News 03/09/2021
COVID-19 vaccines: EMA reviewing cases of multisystem inflammatory syndrome
EMA’s safety committee (PRAC) is assessing whether there is a risk of multisystem inflammatory syndrome (MIS) with COVID-19 vaccines following a report of MIS with Comirnaty. The case occurred in a 17-year old male in Denmark who has since fully recovered.
Some cases of MIS were also reported in the EEA following vaccination with other COVID-19 vaccines.1
MIS is a serious inflammatory condition affecting many parts of the body and symptoms can include tiredness, persistent severe fever, diarrhoea, vomiting, stomach pain, headache, chest pain and difficulty breathing. MIS has previously been reported following COVID-19 disease. The Danish patient, however, had no history of COVID-19.
MIS is rare and its incidence rate before the COVID-19 pandemic estimated from 5 European countries was around 2 to 6 cases per 100,000 per year in children and adolescents below 20 years of age and below 2 cases per 100,000 per year in adults aged 20 years or more.
At this stage, there is no change to the current EU recommendations for the use of COVID-19 vaccines…

News: ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines (new)
Last updated: 02/09/2021
Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued yesterday by the European Centre for Disease Prevention and Control (ECDC). The report also notes that additional doses should already be considered for people with severely weakened immune systems as part of their primary vaccination.
Evidence on vaccine effectiveness and duration of protection shows that all vaccines authorised in the EU/EEA are currently highly protective against COVID-19-related hospitalisation, severe disease and death, while about one out of three adults in the EU/EEA over 18 years is still currently not fully vaccinated. In this situation, the priority now should be to vaccinate all those eligible individuals who have not yet completed their recommended vaccination course. To complement vaccination efforts, it is also crucial to continue applying measures such as physical distancing, hand and respiratory hygiene, and using face masks where needed, in particular in high-risk settings such as long-term care facilities or hospital wards with patients at risk of severe COVID-19…

 

::::::

European Centre for Disease Prevention and Control
https://www.ecdc.europa.eu/en
Latest Updates
News
ECDC awards 77 M€ to strengthen EU/EEA Member States’ capacities to detect and identify SARS-CoV-2 variants
News story – 3 Sep 2021
ECDC has awarded more than 77 M€ to 24 EU/EEA countries to strengthen whole genome sequencing and RT-PCR infrastructures within the countries’ national public health programmes.
The immediate objective is to reinforce countries’ capacities for early detection and enhanced monitoring of emergent and known SARS-CoV-2 variants. The support is a response to a request to ECDC by the European Commission to implement a number of activities that were launched as part of the “HERA Incubator ” aiming to support the rapid detection of SARS-CoV-2 variants across the EU…

News
ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines
Press release – 2 Sep 2021
Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued by the European Centre for Disease Prevention and Control (ECDC). The report also notes that additional doses should already be considered for people with severely weakened immune systems as part of their primary vaccination.

 

Data as of 2021-09-03
https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab

 

European Commission
https://ec.europa.eu/commission/presscorner/home/en
Questions and answers 3 September 2021
Questions and Answers: The EU and AstraZeneca agree on COVID-19 vaccine supply and on ending litigation

Press release 3 September 2021
Coronavirus: The EU and AstraZeneca agree on COVID-19 vaccine supply and on ending litigation
Today the EU and AstraZeneca have reached an agreement which will secure the delivery of the remaining COVID-19 vaccine doses to Member States under the terms of the Advance Purchase Agreement concluded on 27 August 2020 with AstraZeneca.

Press release 31 August 2021
Coronavirus: 70% of the EU adult population fully vaccinated
Today, the EU has reached a crucial milestone with 70% of the adult population now fully vaccinated. In total, over 256 million adults in the EU have now received a full vaccine course.

Russia: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

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Milestones :: Perspectives :: Research

 

Russia: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment
Russia: Sputnik V – “the first registered COVID-19 vaccine”
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
Sputnik V demonstrates 94.8% efficacy against COVID during the vaccination campaign in San Marino
Press release, 02.09.2021

India: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

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Milestones :: Perspectives :: Research

 

India: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

 

Ministry of Health and Family Welfare
https://www.mohfw.gov.in/

Latest Updates
No new digest content identified

 

Government of India – Press Information Bureau
Latest Press Releases
No new digest content identified

 

Indian Council for Medical Research (ICMR)
https://www.icmr.gov.in/media.html
Press Releases
No new digest content identified

China: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

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Milestones :: Perspectives :: Research

 

China: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

Research on link of COVID, cold chain urged
Updated: 2021-09-01| CHINA DAILY
Chinese researchers are calling for global cooperation to improve understanding of the spread of SARS-CoV-2 via cold chains as part of efforts to trace the origins of the virus.
The first phase of WHO-organized studies into the origins of the virus that causes COVID-19 wrapped up in China in February and identified the cold-chain theory as a possible explanation for its spread across populations.
“The cold-chain industry inherently spans the globe. As we are seeing a large amount of science-based evidence pointing to the virus’ spread via cold chains, we suggest the next phase of origin-tracing work involve concerted cold-chain studies under a global framework,” Liu Jun, a professor at the National Institute for Viral Disease Control and Prevention of the Chinese Center for Disease Control and Prevention, said on Friday.
He said Chinese scientists will continue to focus on cold-chain products that arrived in Wuhan, Hubei province, in the four months before the virus emerged in the city in late 2019. Samples will be taken and tested from cold storage…

[Also see China CDC below]

POLIO Public Health Emergency of International Concern (PHEIC)

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Emergencies

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

Polio this week as of 02 September 2021

 

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
:: Pakistan: one WPV1 positive environmental sample
:: Ethiopia: two cVDPV2 cases
:: Gambia: four cVDPV2 positive environmental samples
:: Liberia: one cVDPV2 positive environmental sample
:: Mali: one cVDPV2 case
:: Mauritania: two cVDPV2 positive environmental samples
:: Niger: one cVDPV2 positive environmental sample
:: Nigeria: twenty-three cVDPV2 cases and fifteen cVDPV2 positive environmental samples
:: Senegal: two cVDPV2 positive environmental samples
:: Sierra Leone: one cVDPV2 case
:: Tajikistan: one cVDPV2 case

 

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

WHO/OCHA Emergencies

 

Editor’s Note:
WHO has apparently reorganized and fundamentally shifted how it judges and tracks “emergencies”. We found no announcement of descriptive information to share and present the webpage structure as encountered below. Obviously, the dates associated with some of these emergencies suggest that this is an archival platform as well as a current emergencies resource.

Health emergencies list – WHO
“The health emergencies list details the disease outbreaks, disasters and humanitarian crises where WHO plays an essential role in supporting countries to respond to and recover from emergencies with public health consequences.”

Crisis in Tigray, Ethiopia [Last apparent update: 5 Aug 2021]

Ebola outbreak, Democratic Republic of the Congo, 2021 [Last apparent update: 17 Aug 2021]

Ebola outbreak outbreak, N’Zerekore, Guinea, 2021 [Last apparent update: 17 Aug 2021]

Coronavirus disease (COVID-19) pandemic [See COVID above]

 

Ebola outbreak, Equateur Province, Democratic Republic of the Congo, 2020
[Last apparent update: 17 Aug 2021]

Ebola outbreak, North Kivu, Ituri, Democratic Republic of the Congo, 2018 – 2020
[Last apparent update: 17 Aug 2021]

Ebola outbreak, Democratic Republic of the Congo, 2018 [Last apparent update: 24 July 2018]

Yemen crisis [Last apparent update: 12 February 2021]

Syria crisis [Last apparent update: 18 June 2021]

Somalia crisis [Last apparent update: 24 March 2018]

Nigeria crisis [Last apparent update: 9 May 2018]

Ebola outbreak, Democratic Republic of the Congo, 2017 [Last apparent update: 17 Aug 2021]

Zika virus disease outbreak, 2015-2016 [Last apparent update: 24 Jan 2020]

Ebola outbreak: West Africa, 2014-2016 [Last apparent update: 17 Aug 2021]

Iraq crisis [Last apparent update: 9 Jan 2008]

South Sudan crisis [Last apparent update: 23 Sep 2020]

Avian influenza A (H7N9) virus outbreak
:: 13 September 2021 News release
Upcoming WHO Consultation on the Composition of Influenza Virus Vaccines for the Southern Hemisphere 2022

Middle East respiratory syndrome (MERS-CoV) outbreak [Last apparent update: 8 July 2019]

Influenza A (H1N1) virus, 2009-2010 pandemic [Last apparent update: 10 Aug 2010]

 

::::::

UN OCHA – Current Emergencies
Current Corporate Emergencies
Northern Ethiopia
Ethiopia – Tigray Region Humanitarian Update Situation Report, 2 Sep 2021

 

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

CDC/ACIP [U.S.] [to 04 Sep 2021]

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CDC/ACIP [U.S.] [to 04 Sep 2021]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
CDC Announces More Than $300 Million in Funding to Support Community Health Workers
Friday, September 3, 2021

CDC launches COVID-19 resources for people with intellectual and developmental disabilities
Tuesday, August 31, 2021

CDC Statement Following ACIP Pfizer-BioNTech Vote
Monday, August 30, 2021
[See COVID-USA above for detail]

Africa CDC [to 04 Sep 2021]

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Africa CDC [to 04 Sep 2021]
http://www.africacdc.org/
News
Press Releases
African Vaccine Acquisition Trust delivers 12 000 doses of COVID-19 vaccine to the African Union
ADDIS ABABA, ETHIOPIA, 3 SEPTEMBER  2021 – The African Union (AU), through the Africa Centres for Disease Control and Prevention (Africa CDC), has worked with the African Vaccine Acquisition Trust (AVAT) to secure 12,000 doses of the Johnson and Johnson single-shot COVID-19 vaccine for the African Union Commission (AUC) staff, AU Embassies’ staff and their dependents. The vaccines were handed over to the African Union’s Medical Health Services Directorate (MHSD) today. They arrived on the 1st of September.
The vaccines, partly manufactured in South Africa, were imported with the support of the government of the Federal Democratic Republic of Ethiopia. Being able to offer vaccines to all AUC and AU Embassy staff and their dependents is also an important step in securing the AU’s business continuity…

Press Releases
France works with African partners to deliver 10 million vaccines to Africa
30 August 2021

China CDC

Posted on by

China CDC http://www.chinacdc.cn/en/

National Health Commission of the People’s Republic of China [to 04 Sep 2021]
http://en.nhc.gov.cn/
News
Sept 4: Daily briefing on novel coronavirus cases in China
On Sept 3, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 28 new cases of confirmed infections.

Research on link of COVID, cold chain urged
Updated: 2021-09-01| CHINA DAILY

National Medical Products Administration – PRC [to 04 Sep 2021]
http://english.nmpa.gov.cn/news.html
News
Over 2.07b doses of COVID-19 vaccines administered in China
2021-09-03
More than 2.07 billion doses of COVID-19 vaccines had been administered in China as of Wednesday, data from the National Health Commission showed on Sept 2.

CCDC Weekly – Weekly Reports: Current Volume (3)
2021-09-03 / No. 36
PDF of this issue
:: Outbreak Reports: Five Independent Cases of Human Infection with Avian Influenza H5N6 — Sichuan Province, China, 2021
:: Methods and Applications: The Establishment and Application of Mobile Electronic Surveillance System for Infectious Diseases with the Help of China — Sierra Leone, 2016-Present
:: Notifiable Infectious Diseases Reports: Reported Cases and Deaths of National Notifiable Infectious Diseases — China, June, 2021

Organization Announcements

Posted on by

::::::

 

Organization Announcements
Editor’s Note:
Careful readers will note that the number and range of organizations now monitored in our Announcements section below has grown as the impacts of the pandemic have spread across global economies, supply chains and programmatic activity of multilateral agencies and INGOs.

Paul G. Allen Frontiers Group [to 04 Sep 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

BARDA – U.S. Department of HHS [to 04 Sep 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
News
No new digest content identified.

BMGF – Gates Foundation [to 04 Sep 2021]
https://www.gatesfoundation.org/ideas/media-center
Press Releases and Statements
No new digest content identified.

Bill & Melinda Gates Medical Research Institute [to 04 Sep 2021]
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 04 Sep 2021]
https://carb-x.org/
News
No new digest content identified.

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 04 Sep 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
:: Past weekly editions and posting of all segments of Vaccines and Global Health: The Week in Review are available here.
:: [NEW] Informed Consent: A Monthly Review – September 2021 is now posted here

CEPI – Coalition for Epidemic Preparedness Innovations [to 04 Sep 2021]
http://cepi.net/
Latest News
No new digest content identified.

DARPA – Defense Advanced Research Projects Agency [to 04 Sep 2021
https://www.darpa.mil/news
News
9/2/2021
DARPA Announces Researchers Selected to INCAS Program
Today, DARPA announced the researchers selected to its Influence Campaign Awareness and Sensemaking (INCAS) program. Research teams led by Smart Information Flow Technologies (SIFT), Protagonist Technology, University of Southern California Information Sciences Institute (ISI), University of Illinois Urbana-Champaign, and Uncharted Software will work to develop automated techniques and tools that aid U.S. analysts in the detection and sensemaking of geopolitical online influence campaigns. Additionally, teams led by Lockheed Martin Advanced Technology Laboratories and University of Maryland Applied Research Laboratory for Intelligence and Security (ARLIS) will support test, evaluation, and transition efforts of the resulting INCAS technologies.

Duke Global Health Innovation Center [to 04 Sep 2021]
https://dukeghic.org/
Our Blog
No new digest content identified.

EDCTP [to 04 Sep 2021]
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
No new digest content identified.

Emory Vaccine Center [to 04 Sep 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Vaccine Initiative [to 04 Sep 2021]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

Fondation Merieux [to 04 Sep 2021]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation co-organized event
World Rabies Day 2021: Celebrating action to maintain momentum
September 6, 2021 – Virtual Event

Gavi [to 04 Sep 2021]
https://www.gavi.org/
2 September 2021
Canada donates doses through COVAX – Nigeria, Kenya and Niger to receive first doses

30 August 2021
France donates 10 million doses to Africa through COVAX and AU

GHIT Fund [to 04 Sep 2021]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
No new digest content identified.

Global Fund [to 04 Sep 2021]
https://www.theglobalfund.org/en/news/
News & Stories
New Global Fund Tools to Oversee Grant Investments
02 September 2021

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 04 Sep 2021]
https://www.glopid-r.org/news/
No new digest content identified.

Hilleman Laboratories [to 04 Sep 2021]
http://www.hillemanlabs.org/
Website reports “under maintenance” at inquiry

Human Vaccines Project [to 04 Sep 2021]
http://www.humanvaccinesproject.org/
News
HVP COVID Report
Sep 02, 2021
Laurie Garrett: Is There a COVID-19 Endgame?
[Excerpt]
… Given all of this, what is the endgame for COVID-19?
That is the fundamental question. And it is the one I’ve been asking over and over. Instead of endgame, what even is our strategy? We’re playing football without a coach and without anyone even agreeing on which goal post we’re supposed to run to. We don’t have agreement on national elimination as a strategy versus global eradication, which is the other extreme. We also have no clear effort underway to genuinely ascertain zoonotic spread of this virus. With COVID, we know that the ACE2 receptor in one form or another is in every single mammal. What this tells us is that eradication is going to be incredibly difficult, probably impossible in terms of the firm meaning of the term. It is going to be a permanent part of our environment now and it will be reentering the human species in spillover events from animal populations for the rest of the 21st century.

We need to ask ourselves: what is a reasonable strategic goal? And then design everything accordingly. What we’re facing is a failure to have started with a strategic global plan to begin with. This is the same mess we’re in with climate change, and really all the great supra-national challenges of our time.

You don’t get to an endgame without a strategy. But asking about endgame matters because all military leaders will tell you that you don’t have a strategy until you have a strategic goal. If you don’t have a goal, then all you have is a list of tactics about which you will endlessly debate and that’s exactly where we are now. I don’t see how we easily get past this.

IAVI [to 04 Sep 2021]
https://www.iavi.org/newsroom
Latest News
September 1, 2021
IAVI statement on results from Phase IIb Imbokodo HIV vaccine clinical trial
Janssen-sponsored trial in sub-Saharan Africa discontinued due to lack of efficacy.
Pharmaceutical company Johnson & Johnson today announced the discontinuation of a Phase IIb HIV vaccine clinical trial known as Imbokodo (HVTN 705/HPX2008), sponsored by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Data showed the investigational HIV vaccine regimen did not prevent HIV infection in a population of young women in sub-Saharan Africa at high risk of acquiring HIV. Importantly, the investigational vaccine was found to be safe with no serious adverse events among trial participants.
“Though these results are disappointing, IAVI commends Janssen and the study investigators for their commitment to HIV vaccine science and to conducting the Imbokodo trial safely, ethically, and in global collaboration with public and private institutions as well as communities,” said Mark Feinberg, M.D., Ph.D., President and CEO of IAVI. “A safe, effective, broadly accessible HIV vaccine remains an urgent global health priority. Going forward, IAVI and our collaborators believe that the most promising new HIV vaccine approaches are those intended to induce broadly neutralizing antibodies.”…

 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
No new digest content identified.

ICRC [to 04 Sep 2021]
https://www.icrc.org/en/whats-new
Selected News Releases, Statements, Reports
No new digest content identified.

 

IFFIm
http://www.iffim.org/
Press Releases/Announcements
No new digest content identified.

IFRC [to 04 Sep 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.

Institut Pasteur [to 04 Sep 2021]
https://www.pasteur.fr/en/press-area
Press Documents
No new digest content identified.

IOM / International Organization for Migration [to 04 Sep 2021]
http://www.iom.int/press-room/press-releases
News
No new digest content identified.

ISC / International Science Council [to 04 Sep 2021]
ISC is a non-governmental organization with a unique global membership that brings together 40 international scientific Unions and Associations and over 140 national and regional scientific organizations including Academies and Research Councils.
https://council.science/current/
News
No new digest content identified.

IVAC [to 04 Sep 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

IVI [to 04 Sep 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
IVI 20th International Vaccinology Course kicks off September 6, 2021: Registration open

Johns Hopkins Center for Health Security [to 04 Sep 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
No new digest content identified.

MSF/Médecins Sans Frontières [to 04 Sep 2021]
http://www.msf.org/
Latest [Selected Announcements]
Access to medicines
Lifesaving TB medicines still out of reach for children in high-burden countries
Press Release 3 Sep 2021

Venezuela
Tracking mosquitoes to prevent malaria in Venezuela
Project Update 1 Sep 2021

Lebanon
Healthcare system in Lebanon disintegrates as political vacuum persists
Project Update 1 Sep 2021

Haiti
The long road to recovery for earthquake survivors in Haiti
Project Update 30 Aug 2021

National Academy of Medicine – USA [to 04 Sep 2021]
https://nam.edu/programs/
Selected News/Programs
No new digest content identified.

National Academy of Sciences – USA [to 04 Sep 2021]
http://www.nasonline.org/news-and-multimedia/
News
No new digest content identified.

National Vaccine Program Office – U.S. HHS [to 04 Sep 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
Upcoming Meetings
September 14-15, 2021 NVAC Meeting

NIH [to 04 Sep 2021]
http://www.nih.gov/news-events/news-releases
News Releases
HIV Vaccine Candidate Does Not Sufficiently Protect Women Against HIV Infection
August 31, 2021 — No Safety Concerns Found in Imbokodo Sub-Saharan Africa Study.
An investigational HIV vaccine tested in the “Imbokodo” clinical trial conducted in sub-Saharan Africa posed no safety concerns but did not provide sufficient protection against HIV infection, according to a primary analysis of the study data. The Phase 2b proof-of-concept study, which began in November 2017, enrolled 2,637 women ages 18 to 35 years from five countries…

PATH [to 04 Sep 2021]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

Sabin Vaccine Institute [to 04 Sep 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

UNAIDS [to 04 Sep 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
No new digest content identified.

UNHCR Office of the United Nations High Commissioner for Refugees [to 04 Sep 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected News Releases, Announcements
Unprecedented displacement in Central America and Mexico calls for urgent regional responsibility sharing
2 Sep 2021
SAN SALVADOR – Central America and Mexico are facing unprecedented pressure as the number of people seeking international protection rises at a time when access to asylum and territory is being limited through troubling border restrictions, said Gillian Triggs, UNHCR’s Assistant High Commissioner for Protection, on wrapping up a two-week mission to the region.
“In Mexico, Guatemala and El Salvador, I have seen the tremendous strain the region is under because of the increasing flows of refugees and migrants. Extraordinary efforts are being made by governments and civil society to address these challenges,” Triggs said.
In conversations with internally displaced people, asylum seekers and refugees, Triggs heard stories of sexual violence, death threats and extortion in communities controlled by criminal gangs that – often coupled with economic hardship and the effects of climate change – have forced nearly a million people from El Salvador, Guatemala, and Honduras to flee their homes….

 

‘After the airlift’. News Comment attributable to UN High Commissioner for Refugees Filippo Grandi
The evacuation from Kabul is coming to an end. A larger crisis is just beginning.
30 Aug 2021

 

The 1961 Statelessness Convention: 60 years of promoting and protecting the right to a nationality
30 Aug 2021

UNICEF [to 04 Sep 2021]
https://www.unicef.org/media/press-releases
Press Releases, News Notes, Statements [Selected]
Press release 09/02/2021
Haiti earthquake: over half a million children at risk of waterborne diseases – UNICEF

Press release 08/30/2021
All schools in Europe & Central Asia should remain open and made safer from COVID-19, say WHO and UNICEF
As millions of school children return to school across the European Region where the highly transmissible SARS-CoV-2 Delta variant is dominant, the WHO Regional Office for Europe and UNICEF ECARO call for schools to stay open

Unitaid [to 04 Sep 2021]
https://unitaid.org/
Featured News
No new digest content identified.

Vaccine Equity Initiative [to 04 Sep 2021]
https://vaccineequitycooperative.org/news/
News
No new digest content identified.

Vaccination Acceptance & Demand Initiative [Sabin) [to 04 Sep 2021]
https://www.vaccineacceptance.org/
Announcements
No new digest content identified.

Vaccine Confidence Project [to 04 Sep 2021]
http://www.vaccineconfidence.org/
News, Research and Reports
INFODEMIC A Stanford Conference on Social Media and COVID Misinformation
Sep 4, 2021
Prof. Heidi Larson introduces Stanford University’s conference Social Media and COVID Misinformation. The conference engaged experts in the fields of biomedical ethics, public health, and cyber policy with representatives from social media companies, popular blog sites, and the public to examine the intersection of social media, ethics, and COVID misinformation.
Video: https://youtu.be/ursrN7UXbPo

Coronavirus global impact
Launched April 2, 2020 and recurring every 3 days, Premise Data is utilizing its global network of Contributors to assess economic, social, and health sentiment surrounding the coronavirus (COVID-19).

Vaccine Education Center – Children’s Hospital of Philadelphia [to 04 Sep 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

Wellcome Trust [to 04 Sep 2021]
https://wellcome.ac.uk/news
News and reports
Opinion
Authors: Alison Doig, Modi Mwatsama
Countdown to COP26: four actions global leaders can take to tackle the climate crisis and improve health
1 September 2021

The Wistar Institute [to 04 Sep 2021]
https://www.wistar.org/news/press-releases
Press Releases
The Wistar Institute Recruits Vaccine Researcher Amelia Escolano, Ph.D., and Immunologist Nan Zhang, Ph.D., as Assistant Professors
PHILADELPHIA — (Sept. 1, 2021) — The Wistar Institute, an international biomedical research leader in cancer, immunology and infectious diseases, welcomes Amelia Escolano, Ph.D., and Nan Zhang, Ph.D., as assistant professors.

Press Release
The Wistar Institute Appoints Italo Tempera, Ph.D., as Associate Director for Cancer Research Career Enhancement of Its Cancer Center
PHILADELPHIA — (Aug. 31, 2021) — The Wistar Institute announces the appointment of Italo Tempera, Ph.D., as Associate Director for Cancer Research Career Enhancement at the Institute’s Cancer Center. In this role, Tempera, who is also an associate professor in the Gene Expression & Regulation Program, will lead the educational mission of the Institute and its Cancer Center to train scientists and create workforce development programs in the life sciences.

WFPHA: World Federation of Public Health Associations [to 04 Sep 2021]
https://www.wfpha.org/
Latest News
No new digest content identified.

World Bank [to 04 Sep 2021]
http://www.worldbank.org/en/news/all
Selected News, Announcements
No new digest content identified.

World Customs Organization – WCO [to 04 Sep 2021]
http://www.wcoomd.org/
Latest News – Selected Items
2nd edition of the Secretariat Note on the role of Customs in facilitating and securing the cross-border movement of situationally critical medicines and vaccines
May 2021
The objective of this document is to provide guidance with regard to the implementation by Members of the twelve measures outlined in the WCO Resolution on the Role of Customs in facilitating the cross-border movement of situationally critical medicines and vaccines, as well as provide information on WCO instruments and tools that can support the implementation of the Resolution, and on Members’ good practices.

Joint Indicative List of Critical COVID-19 Vaccine Inputs
7 Jul 2021
The joint indicative list seeks to compile information on the critical inputs for the manufacturing, distributing and administering of COVID-19 vaccines that has been produced by several organizations. It was first compiled by the WTO Secretariat as a working document to facilitate discussions at the WTO COVID-19 Vaccine Supply Chain and Regulatory Transparency Symposium that took place on 29 June 2021. The list is purely indicative and subject to further clarification, modification, and improvement based on inputs by pharma and customs experts. It is based on the HS 2017 version and is without prejudice to the actual tariff classification assigned by WTO Members’ customs administrations at the time of importation. The list has no legal status and is without prejudice to the rights and obligations of WTO Members.

World Organisation for Animal Health (OIE) [to 04 Sep 2021]
https://www.oie.int/en/for-the-media/press-releases/2021/
Press Releases, Statements
No new digest content identified.

WTO – World Trade Organisation [to 04 Sep 2021]
http://www.wto.org/english/news_e/news_e.htm
WTO News and Events
How can cooperation on trade contribute to the United Nations Environment Assembly (UNEA) process on plastic pollution?
2 September 2021
Event organized by UNCTAD, UNEP, the Forum on Trade, Environment and the SDGs, and the Government of Ecuador
Remarks by DDG Paugam
News item

 

::::::

ARM [Alliance for Regenerative Medicine] [to 04 Sep 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Selected Press Releases
No new digest content identified.

BIO [to 04 Sep 2021]
https://www.bio.org/press-releases
Press Releases, Letters, Testimony, Comments [Selected]
No new digest content identified.

DCVMN – Developing Country Vaccine Manufacturers Network [to 04 Sep 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

ICBA – International Council of Biotechnology Associations [to 04 Sep 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

IFPMA [to 04 Sep 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

 

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
No new digest content identified.

International Alliance of Patients’ Organizations – IAPO [to 04 Sep 2021]
https://www.iapo.org.uk/news/topic/6
Press and media [Selected]
No new digest content identified.

PhRMA [to 04 Sep 2021]
http://www.phrma.org/
Latest News [Selected]
The impact of monoclonal antibodies and COVID-19 recovery
September 2, 2021
Monoclonal antibodies are a type of biologic medicine that play a central role in advancing our ability to treat a range of diseases.
Blog Post

Journal Watch

Posted on by

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

How Differently Should the FDA Regulate Drugs and Devices?

Posted on by

AMA Journal of Ethics
Volume 23, Number 9: E667-756 Sep 2021
https://journalofethics.ama-assn.org/issue/implantable-material-and-device-regulation

 

Implantable Material and Device Regulation
About 10% of Americans will have a device implanted into their bodies during their lifetimes. Fewer than 0.5% of these devices, however, are likely to have been tested in rigorous clinical trials generally regarded as standard by US regulators. Despite looser regulation of materials and devices than for pharmaceuticals, clinician-investigators and the Food and Drug Administration are obligated to balance patient-subjects’ safety with demand for patients’ timely access to technologies and interventions that might improve or extend their lives. This issue investigates that tension.
From the Editor
Sep 2021
How Differently Should the FDA Regulate Drugs and Devices?
Ariel Wampler, MD
This issue invites clinicians, researchers, device representatives, and patient-safety champions to consider how to exercise sufficient caution without stifling innovation.