Media/Policy Watch

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

 

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 18 Apr 2020
Ideas
America’s COVID-19 Disaster Is a Setback for Democracy
If the country’s institutions cannot function effectively during a crisis, and especially if a view takes hold that authoritarian regimes are managing the crisis more decisively, a grim future lies ahead.
April 16, 2020 , Larry Diamond
Senior fellow at the Hoover Institution at Stanford University

 

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

 

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

 

Financial Times
http://www.ft.com/home/uk
Accessed 18 Apr 2020
[No new, unique, relevant content]

 

Forbes
http://www.forbes.com/
Apr 15, 2020
Optum CEO Witty To Take Leave To Join WHO’s COVID-19 Vaccine Effort
UnitedHealth Group’s Sir Andrew Witty will take a leave of absence running Optum to “co-lead a global effort of the World Health Organization” to develop a vaccine for the Coronavirus strain COVID-19.
B y Bruce Japsen, Senior Contributor

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 18 Apr 2020
World   Apr 17, 2020 Snapshot
Mass Consumption Is What Ails Us
Pandemics are not arbitrary calamities, but instead probabilistic events made more likely by human agency. This means that averting future pandemics requires a…
Sonia Shah

United States   Apr 17, 2020 Snapshot
Technology Can Help Solve the Coronavirus Crisis If Government Steps Up
Washington has already missed the opportunity to use digital tools that could have saved lives in the early months of the crisis. Now it stands poised to miss a chance…
Mira Rapp-Hooper and Samm Sacks

 

Foreign Policy
http://foreignpolicy.com/
Accessed 18 Apr 2020 |
Pentagon Considers Extending Enlistments During Pandemic
Senior defense official expects to see more impacts to war readiness as the coronavirus outbreak hampers recruiting and halts travel.
Q&A | Jack Detsch

 

The Remaking of Big Pharma in a Post-Pandemic World
COVID-19 has bucked conventional wisdom on how the industry must operate.
Argument | Ethan Guillén, Melissa Chan

 

How Globalization Will Look After the Coronavirus Pandemic
New barriers are going up at breathtaking speed. The pandemic will accelerate not the demise of globalization, but its transformation.
Argument | Richard Fontaine

 

The Guardian
http://www.guardiannews.com/
Accessed 18 Apr 2020
Opinion Coronavirus outbreak
Africans facing coronavirus must not suffer the injustices they saw with AIDS
Sat 18 Apr 2020 Lydia Namubiru

Opinion Technology
When Covid-19 has done with us, what will be the new normal?
From online GPs and home working to smartphone tracking, the speed at which we are embracing technology is unprecedented – but can we trust it?
Sat 18 Apr 2020 John Naughton

 

New Yorker
http://www.newyorker.com/
Accessed 18 Apr 2020
Dispatch
Seoul’s Radical Experiment in Digital Contact Tracing
In South Korea, the government is disseminating detailed tracking data on people with COVID-19.
By Max S. Kim

Q. & A.
Gordon Brown’s Case for Global Coöperation During COVID-19
By Isaac Chotiner

News Desk
How Spain’s Coronavirus-Infection Rate Became One of the World’s Highest
By Stephania Taladrid

Dispatch
Will the Coronavirus Spare the World’s Most Remote Places?
Villages in Alaska are sealing themselves off from the outside world to prevent infection; if the pandemic arrives, it will be devastating.
By Caroline Lester
April 17, 2020

 

New York Times
http://www.nytimes.com/
Accessed 18 Apr 2020
Asia Pacific
UK Scientists to Make a Million Potential COVID-19 Vaccines Before Proof
A million doses of a potential COVID-19 vaccine being developed by British scientists are already being manufactured and will be available by September, even before trials prove whether the shot is effective, the team said on Friday.
By Reuters
Apr 17

Africa
Congo Records Five New Ebola Cases, Shelves Declaration of End to Epidemic
Five new Ebola infections have been recorded in eastern Congo since last week in a new flare-up just as the government was about to declare an end to the deadly epidemic, the World Health Organization said on Friday.
By Reuters
Apr 17

World
Draft UN Resolution Urges Global Access to COVID-19 Material
The U.N. General Assembly has until Monday to consider a draft resolution calling for global action to rapidly scale up development, manufacturing and access to medicine, vaccines and medical equipment to confront the coronavirus pandemic.
By The Associated Press
April 17

 

Washington Post
https://www.washingtonpost.com/
Accessed 18 Apr 2020
[No new, unique, relevant content]

 

Think Tanks et al

Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 18 Apr 2020
Future Development
How Congress can address the international dimensions of the COVID-19 response
George Ingram and Jeffrey L. Sturchio
Wednesday, April 15, 2020

Center for Global Development [to 18 Apr 2020]
http://www.cgdev.org/page/press-center
Selected Publications, News and Events
April 17, 2020
The Risks Posed by Covid-19 Are Gendered. Our Response Should Be as Well.
In a webcast event hosted by CGD, Megan O’Donnell spoke with researchers, practitioners, and advocates to highlight and contextualize data on how this global crisis presents specific gendered risks, and how, in turn, a gender-sensitive response can help us tackle new and worsening inequalities
Shelby Bourgault

April 17, 2020
As Outcomes Are Uncertain, Pick No-Regret Policies
With so much uncertainty around COVID-19, it helps to focus on decisions that no one will regret later on, that are right whether the crisis is short or long, the recession deep or shallow. These are “no-regret policies.”
Stefan Dercon

No-Regret Policies for the COVID-19 Crisis in Developing Countries
Publication
4/17/20
Given the massive uncertainty surrounding how COVID-19 will play out in terms of health outcomes as well as economic and social outcomes, policymaking is as hard as it can possibly be. No-regret policies are those that are worth doing now regardless of which scenario actually plays out.

 

CSIS
https://www.csis.org/
Accessed 18 Apr 2020
Commentary
Public Surveillance to Keep Us Healthy and Protect Our Privacy
April 16, 2020 | By Glenn S. Gerstell

Commentary
Find My Friends in a Pandemic: The Future of Contact Tracing in America
April 16, 2020 | By Anna Carroll, Samantha Stroman

 

Council on Foreign Relations
http://www.cfr.org/
Accessed 18 Apr 2020
[No new relevant content]

 

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

 

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

.– 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_11 April 2020

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

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

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

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

Highlights from the Meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization

Milestones :: Perspectives :: Research

 

Highlights from the Meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization
31 March -1 April 2020
The full report with final recommendations will be published in the Weekly Epidemiological Record on 29 May 2020.
[Editor’s text bolding]
Global and Regional Reports
:: In the context of the COVID-19 pandemic and its impact on primary health and immunization services across the world, SAGE stressed the imperative to explore innovative approaches and to seize opportunities that may emerge from this crisis to move the global immunization agenda forward, as outlined within the Director’s report. These opportunities include using subnational data to drive vaccination coverage, tailoring local immunization programs, improving the design of clinics, accelerating the use of integrated campaigns and of life course immunization, addressing gender inequities, and overcoming fragmentation of vaccine-preventable disease surveillance. Implementing the strategic objectives of the Immunization Agenda 2030 will become even more important to address the challenges of and eventual recovery from the COVID-19 pandemic.

:: The Regional reports confirmed the challenges that countries will experience to sustain immunization activities in the current COVID-19 context. Furthermore, continued high numbers of measles cases and outbreaks were highlighted in various regions; these are likely to increase.

:: SAGE was updated on key COVID-19 modelling results for transmissibility, serial interval, incubation period, severity of the disease, risk groups, asymptomatic infections and role of public health interventions and social measures.

 

:: SAGE members stressed that safeguarding immunization services was of critical importance during the current pandemic and adequate catch-up activities should be planned at this stage to ensure that children receive all their needed vaccines.

:: Gavi expressed its concerns on the implications of COVID-19 on routine immunization, with an anticipated plummet of routine immunization coverage and emergence of outbreaks of VPD. Gavi outlined its engagement in response to the COVID-19 pandemic with providing immediate support to countries.

:: As a milestone in maintaining and enhancing the support to Gavi countries is the Gavi replenishment forum in June 2020. SAGE underlined its importance and the need to obtain adequate financial resources to enable the Alliance to continue its critical work. Gavi 5.0 objectives are more relevant than ever in light of the emerging crisis.

:: Industry from both developing and high income countries expressed concern that a prolonged COVID-19 crisis may impact its ability to manufacture and distribute live-saving vaccines.

 

Update on COVID-19 vaccine
:: SAGE acknowledged the unprecedent effort to develop a COVID-19 vaccine and requested that studies give due attention to vaccine performance in vulnerable populations and in low and middle income countries.

:: SAGE commended the early collaboration with key technical partners on consideration of use scenarios, access, availability and supply..

:: SAGE discussed the need to establish a SAGE Working Group on COVID-19 Vaccines to advise on strategies and use scenarios for investigational and licensed COVID vaccines. SAGE requested that the Working Group be constituted now to permit active involvement of SAGE in WHO processes to advise on product profile and target groups for vaccine evaluation.

 

Update on Ebola vaccine
:: The Eastern Democratic Republic of Congo (DRC) Ebola outbreak is coming to an end with no new cases reported since 17 February 2020, and more than 320 000 individuals vaccinated.

:: SAGE again acknowledged the huge efforts by the frontline workers to vaccinate large populations under extremely difficult conditions.

:: In a subsequent meeting, SAGE will discuss possible off-label recommendations for the licensed rVSV-ZEBOV vaccine to allow its appropriate use in future outbreaks.

:: SAGE recommended that a comprehensive review be conducted of the recent experience of Ebola vaccine implementation and policy development during an outbreak response in order to inform future processes for the development of recommendations, the use and the monitoring of un-licensed vaccines in emergency situations.

 

Measles outbreak epidemiology and WHO coordination
:: In the setting of the increased numbers of measles outbreaks throughout the world since 2019, SAGE expressed concern that the COVID-19 pandemic will further strain measles control efforts. Countries and immunization partners will need to re-double immunization efforts, guided by the recently published “WHO Guiding principles for immunization activities during the COVID-19 pandemic.”

:: SAGE was updated on newsworthy or graded measles outbreaks (e.g., Democratic Republic of Congo, European region) as well as on success stories (e.g., China, Colombia) and the WHO global response, including advice from the Strategic Technical Advisory Group – Infectious Hazards (STAG-IH) of WHO, and the development of the Global Strategic Response Plan and other measures.

:: An update on the ongoing measles and rubella policy and strategy work was provided, including the presentation of the Measles Eradication Feasibility Report to the Executive Board (EB) in February 2020 and World Health Assembly (WHA) in May 2020 with the Immunization Agenda 2030; the proposed M&E framework for measles and rubella; a benchmarking process to define an evidence based process to consider measles eradication; the Measles Rubella Strategic Framework.

 

Polio
:: SAGE expressed concern about the continuing upsurge in wild poliovirus cases and by the inability of the polio eradication program to effectively control outbreaks of vaccine derived polioviruses in Africa and Asia.

:: SAGE took note of the current reorientation of polio resources for country COVID-19 responses. In practice, this results in a halt of polio activities. The Global Polio Eradication Programme (GPEI) plans to monitor the COVID-19 situation and prepare scenarios for program restart vaccination activities.

:: SAGE reconfirmed the prioritization of available inactivated polio vaccine (IPV) supply for 2020: 1. Routine immunization, 2. Catch-up of missed children due to delayed introduction 3. Supplemental Immunization Activities for endemic countries and high-risk areas, based on risk assessment 4. Introduction of second dose of IPV into routine immunization. However, for 2021, SAGE agreed that the introduction of a second dose of IPV into routine immunization (currently 4th place) will be prioritized over IPV for SIAs for endemic countries and high-risk areas (currently 3rd place).

:: In terms of tOPV, SAGE endorsed that tOPV may be made available to countries for cVDPV2 outbreak response in subnational areas where there is co-circulation or high risk of co-circulation of cVDPV2 with cVDPV1, cVDPV3 or wild type 1 poliovirus in order to avoid the need for dual mOPV2 and bOPV campaigns. Use of tOPV will require the same authorizations and restrictions as required for use of mOPV2.

:: SAGE endorsed in principle criteria for initial nOPV2 use under emergency use listing (EUL) in cVDPV2 outbreak response and will continue to monitor and further review this in the future.

:: In the current epidemiological context, SAGE expressed caution over regions or countries moving from bOPV to an IPV-only schedule as a general principle and recommended that instead these regions or countries take a gradual approach, first introducing a 2nd dose of IPV into routine immunization.

 

:: SAGE concluded that a key lesson from the switch is that the GPEI cannot plan for complete cessation of OPV with the tools and knowledge that are currently available.

IA2030 Monitoring and Evaluation framework
:: SAGE was presented with initial framework of the monitoring and evaluation and accountability (M&E/A) framework for the immunization strategy for the new decade. The final framework is expected to be submitted to the WHO EB and WHA in 2021 for endorsement.

:: SAGE supports the proposed IA2030 ME&A Framework principles as well as the approach to defining indicators and targets in a lean and action-oriented manner.

:: SAGE stressed the need to concentrate ME&A efforts to enable country programme strengthening and continuous quality improvement resulting in community/facility level improvements.

 

Global Vaccine Safety Blueprint 2.0
:: SAGE acknowledged the significant progress made in strengthening the capacity of countries to address vaccine safety issues in all WHO regions since 2012 through the implementation of the Global Vaccine Safety Blueprint 1.0 (GVSB 1.0) and endorses the GVSB 2.0.

:: In order to make GVSB 2.0 more aligned with the Immunization Agenda 2030, SAGE suggested that the country ownership and country driven aspects be incorporated into the document with an emphasis on a bottom-up approach to mirror the IA2030 philosophy.

:: The role of Civil Service Organizations (CSO) in Adverse Events Following Immunization (AEFI) reporting from the family level should be emphasized. CSOs could have a role in vaccine safety by encouraging family level and community level reporting and by assisting in the design of governance systems as well as in the monitoring of AEFI’s and rumors.

World Faces ‘Gravest Test’ since Founding of United Nations, Secretary-General Tells Security Council, Calling for Unity to Address COVID-19 Pandemic

Milestones :: Perspectives :: Research

 

COVID-19 :: United Nations Response

World Faces ‘Gravest Test’ since Founding of United Nations, Secretary-General Tells Security Council, Calling for Unity to Address COVID-19 Pandemic
9 April 2020 SG/SM/20041
Following are UN Secretary-General António Guterres’ remarks to the Security Council on the COVID-19 pandemic, in New York, today:
Thank you for convening this important discussion.  The world faces its gravest test since the founding of this Organization.  Every country is now grappling with or poised to suffer the devastating consequences of the COVID-19 pandemic:  the tens of thousands of lost lives; the broken families; the overwhelmed hospitals; the overworked essential workers.

We are all struggling to absorb the unfolding shock:  the jobs that have disappeared and businesses that have suffered; the fundamental and drastic shift to our daily lives; and the fear that the worst is still yet to come, especially in the developing world and countries already battered by armed conflict.

 

While the COVID-19 pandemic is first and foremost a health crisis, its implications are much more far-reaching.  We are already seeing its ruinous social and economic impacts, as Governments around the world struggle to find the most effective responses to rising unemployment and the economic downturn.  But, the pandemic also poses a significant threat to the maintenance of international peace and security — potentially leading to an increase in social unrest and violence that would greatly undermine our ability to fight the disease.

My concerns are many and widespread, but let me identify eight risks that are particularly pressing…
[Full text at title link above] 

 

::::::

World Health Organization ‘Absolutely Critical’ to Global Fight against COVID-19, Secretary-General Says, Calls for Support, Unity
8 April 2020 SG/SM/20038
The following statement by UN Secretary-General António Guterres was issued today:
The COVID-19 pandemic is one of the most dangerous challenges this world has faced in our lifetime.  It is above all a human crisis with severe health and socioeconomic consequences.

The World Health Organization (WHO), with thousands of its staff, is on the front lines, supporting Member States and their societies, especially the most vulnerable among them, with guidance, training, equipment and concrete life-saving services as they fight the virus.

I witnessed first-hand the courage and determination of WHO staff when I visited the Democratic Republic of the Congo last year, where WHO staff are working in precarious conditions and very dangerous remote locations as they fight the deadly Ebola virus.  It has been a remarkable success for WHO that no new cases of Ebola have been registered in months.

It is my belief that the World Health Organization must be supported, as it is absolutely critical to the world’s efforts to win the war against COVID-19.

 

This virus is unprecedented in our lifetime and requires an unprecedented response.  Obviously, in such conditions, it is possible that the same facts have had different readings by different entities.  Once we have finally turned the page on this epidemic, there must be a time to look back fully to understand how such a disease emerged and spread its devastation so quickly across the globe, and how all those involved reacted to the crisis.  The lessons learned will be essential to effectively address similar challenges, as they may arise in the future.

But now is not that time.  Now is the time for unity, for the international community to work together in solidarity to stop this virus and its shattering consequences.

COVID-19 R&D

Milestones :: Perspectives :: Research

 

COVID-19 R&D

[Editor’s Note:
IFPMA appears to be updating and extending its “backgrounder” each week, providing an inventory of company initiatives involving development of vaccines, treatments and diagnostics. We will monitor and provide an excerpt as it is the most comprehensive list we have encountered]

IFPMA Backgrounder – COVID-19
10 April 2020
[Excerpts]
… Vaccine development
While vaccines and small molecule treatments are approved through different regulatory pathways and their development programs vary, they generally both must complete three phases of clinical trials. However, there are differences in the data required to show the safety of vaccines and the size of clinical trials for vaccines relative to small molecules.
Experts are hoping it will take as little as 12 to 18 months before there is a vaccine available. This is a best-case estimate that assumes one or two of the first few vaccines that enter development will be successful. Typically, only approximately one in ten experimental vaccines make it all the way through to regulatory approval. Therefore, the more companies taking different approaches to find a vaccine, the more “shots on goal” and significantly greater chances of success.
:: CEPI and GSK will collaborate to help the global effort to develop a vaccine for the novel coronavirus. GSK is making its adjuvant technology available to support rapid development of candidate vaccines and is working with The University of Queensland, Australia.
:: CSL Limited/ Seqirus is providing scientific and technical expertise and its established MF59® adjuvant technology to the University of Queensland in Australia to help fast-track the development of their CEPI-funded COVID-19 vaccine candidate, which uses novel molecular-
:: GSK announced it would partner with the Chinese biotech company Clover Biopharmaceuticals. Under the partnership, GSK will provide Clover with its proprietary
adjuvants – compounds that enhance the effectiveness of vaccines. By mid-March, GSK expanded their collaborations and is now working with five partner companies and research groups across the world, including in the USA and China.
:: Johnson & Johnson expanded its collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of U.S. Department of Health & Human Services (HHS), and established a new collaboration with Beth Israel Deaconess Medical Center (BIDMC), to accelerate development of a potential novel coronavirus vaccine.
:: Johnson & Johnson announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine.
:: Pfizer and BioNTech have entered into a partnership to jointly develop BioNTech’s mRNA-based vaccine candidate BNT162 to prevent COVID-19 infection. The collaboration aims to accelerate global development of BNT162, which is expected to enter clinical testing by the end of April 2020. BioNTech and Pfizer will also work jointly to commercialize the vaccine worldwide (excluding China which is already covered by BioNTech’s collaboration with Fosun Pharma) upon regulatory approval.
:: Sanofi announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), to advance a novel COVID-19 vaccine candidate. Work is underway to leverage previous development of a SARS vaccine candidate using Sanofi’s recombinant DNA technology. Sanofi is also coordinating with the Coalition for Epidemic Preparedness Innovations (CEPI) and sharing its vaccine R&D experience and expertise to advance vaccine solutions.
:: Sanofi and U.S. company Translate Bio announced plans to collaborate on developing a vaccine to treat the coronavirus. The companies said Translate Bio would work on discovering, designing, and manufacturing a number of SARS-CoV-2 vaccine candidates, while Sanofi would provide its expertise in the field of vaccines and support from its research networks.

 

Treatment development
Currently a number of existing and new treatments are in various research phases and clinical trials to test their efficiency and safety for treating COVID-19. Listed below is a snapshot of the different areas of research focused on finding an effective treatment.
:: AbbVie announced it is partnering with global authorities to determine the effectiveness of HIV drugs in treating COVID-19. AbbVie is supporting clinical studies and basic research with lopinavir/ritonavir, working closely with European health authorities and the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention, National Institutes of Health and the Biomedical Advanced Research and Development Authority to coordinate these efforts.
:: Amgen and Adaptive Biotechnologies (Seattle, USA) are partnering to combine expertise to discover and develop fully human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19.
:: AstraZeneca’s Research and Development (R&D) teams have also been working expeditiously to identify monoclonal antibodies to progress towards clinical trial evaluation as a treatment to prevent COVID-19. More than 50 virology, immunology, respiratory, and protein engineering experts across research, clinical, regulatory, and manufacturing are placing the highest priority on developing a treatment to minimise the global impact of the disease.
:: Boehringer Ingelheim is searching for novel virus-neutralizing antibodies. It is also screening its entire molecule library for compounds that could target the virus. Boehringer Ingelheim actively participates with its COVID-19 projects in the Innovative Medicines Initiative (IMI) of the European Union and the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation.
:: Bristol Myers Squibb (BMS) identified 1,000 compounds in its discovery library that they are making available to collaborators for screening for potential treatments for COVID-19. BMS is actively evaluating certain medicines in its portfolio that could be included in near-term clinical trials with a focus on agents impacting the inflammatory immune response associated with COVID-19.
:: Chugai (daughter of Roche) is working to start a Phase III clinical trial in Japan with Actemra® Chugai filed a clinical trial notification with the Pharmaceuticals and Medical Devices Agency on April 8th, 2020. It hopes to enroll patients hospitalized with severe COVID-19 soon.
:: CSL Behring (CSL Limited is the parent company) together with Takeda set up a partnership bringing together world-leading plasma companies to focus on developing and delivering a hyperimmune immunoglobulin in the global fight against COVID-19.
:: Eli Lilly and AbCellera (Canadian biotech firm) have entered into an agreement to co-develop antibody products for the treatment and prevention of COVID-19. The collaboration will leverage AbCellera’s rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform (P3) Program, and Lilly’s global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies.
:: EFPIA is working with the Innovative Medicines Initiative (IMI) on potential actions to support collaborative research programs in order to fast-track the development of therapeutics.
:: Eisai is participating in the COVID-19 Therapeutics Accelerator initiated by the Bill & Melinda Gates Foundation. The company is planning to provide its natural product libraries as well as its new vaccine adjuvant.
:: Gilead has initiated two Phase 3 clinical trials of remdesivir in countries with high prevalence of COVID-19. The company is also supporting two Phase 3 trials in China and a global Phase 2 trial led by the U.S. National Institute of Allergy and Infectious Diseases. Gilead donated drug and provided scientific input for these studies. Gilead has provided remdesivir to physicians for compassionate use to treat several hundred severely ill patients with confirmed COVID-19, and has accelerated manufacturing of remdesivir at risk, in anticipation of potential future supply needs.
:: GSK is entering into the new collaborative research effort, the COVID-19 Therapeutics Accelerator. The aim of the Accelerator is to bring pharmaceutical companies and expert academic institutions into coordinated research programs, with the aim of bringing the most promising molecules forward that could be used to treat cases of COVID-19. GSK will contribute by making available compounds from its libraries for screening for activity against COVID-19. In addition, GSK is evaluating its marketed pharmaceutical products and medicines in development to determine if any could be used beyond their current indications in response to the pandemic. Further, GSK is evaluating options to make available specialised laboratory space to help in research and testing of COVID-19.
:: GSK and Vir Biotechnology, Inc. signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration will use Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options to help address the current COVID-19 pandemic and future outbreaks.
:: GSK announced plans to collaborate with China’s Xiamen Innovex on a potential vaccine to treat the COVID-19 coronavirus. The companies are testing a recombinant protein-based coronavirus vaccine candidate, which is being developed by Innovax with Xiamen University.
:: Ipsen donated financial resources to the Institut Pasteur to support research on COVID-19. Since January, the Institut Pasteur has devoted a portion of its research to understanding the emerging COVID-19 virus, in terms of epidemiology, biological characteristics, pathogenicity.
:: Johnson & Johnson, in partnership with the Rega Institute for Medical Research, University of Leuven (Belgium), are working to identify existing or new compounds with antiviral activity against COVID-19 that could contribute to providing immediate relief to the current outbreak.
:: Merck, as part of the global effort to investigate potential therapeutics for COVID-19 and their support of independent research, recently donated a supply of interferon beta-1a (Rebif®) to the French Institut National de la Santé et de la Recherche Médicale (INSERM) following a request for use in a clinical trial. To date, Merck’s interferon beta-1a is not approved by any regulatory authority for the treatment of COVID-19 or for use as an antiviral agent.
:: Merck is donating 290,000 units of its interferon beta-1a (Rebif®) to the WHO for use in their global SOLIDARITY trial which investigates several potential therapeutics for the treatment of COVID-19.
:: Novartis announced that it has entered new collaborative research efforts such as the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard, as well as a COVID-19 directed partnership organized by the Innovative Medicines Initiative. Novartis is contributing by making available several compounds from its libraries that are considered suitable for in vitro antiviral testing. In addition, the company is rapidly evaluating other existing products to see if any could be utilized beyond their approved indications in response to the pandemic.
:: Novartis plans to initiate a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi® (ruxolitinib) for treatment of a type of severe immune overreaction called cytokine storm that can lead to life-threatening respiratory complications in patients with COVID-19.
:: Pfizer announced that it completed a preliminary assessment of certain antiviral compounds that were previously in development and that inhibited the replication of coronaviruses similar to the one causing COVID-19 in cultured cells. Pfizer is engaging with a third party to screen these compounds under an accelerated timeline and expects to have the results back by the end of March.
:: Pfizer also outlined a detailed 5-point action plan to battle COVID-19. The plan includes a commitment to sharing its clinical development and regulatory expertise to support other smaller biotech companies that are screening compounds or existing therapies for activity against the virus causing COVID-19.
:: Pfizer shared preliminary data confirming the anti-SARS-CoV-1 compound shows antiviral activity against SARS-CoV-2. Pfizer will perform pre-clinical confirmatory studies, including further anti-viral profiling and assessment of the suitability of the lead molecule for IV administration clinically.
:: Pfizer and the Liverpool School of Tropical Medicine’s Respiratory Infection Clinical Research Group are launching two new studies to provide insights on the interaction between S. pneumoniae and SARS-CoV-2. The SAFER study and FASTER study will help demonstrate whether patients infected with COVID-19 have a higher risk of also developing pneumococcal pneumonia and if having both infections leads to more severe disease and poorer outcomes.
:: Regeneron Pharmaceuticals announced an expanded agreement with the U.S. Department of Health and Human Services (HHS) to develop new treatments combating the novel coronavirus.
:: Regeneron Pharmaceuticals and Sanofi SA started a clinical program evaluating Kevzara, originally a drug to treat arthritis, in patients hospitalized with severe COVID-19. Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19 infection.
:: Roche’s Actemra was approved by China on March 5 to treat Covid-19 patients with lung complications. Roche has donated nearly $2m-worth of Actemra to China to help the
country manage the COVID-19 outbreak”. Actemra has been on the European market since 2010 for treatment of several kinds of arthritis.
:: Roche announced that they are working with the Food & Drug Administration (FDA) to initiate a Phase III clinical trial to evaluate the safety and efficacy of Actemra in hospitalised adult patients with severe COVID-19 pneumonia. This is the first global study of Actemra in this setting and is expected to begin enrolling as soon as possible in early April with a target of approximately 330 patients globally, including the US.
:: Takeda announced that it is initiating the development of a drug to treat people infected with the novel coronavirus. The experimental drug would be derived from the blood of coronavirus patients who have recovered from the respiratory disease. In parallel, Takeda is also exploring whether currently marketed and pipeline products may be an effective treatment option for infected patients.
:: Takeda together with CSL Behring set up a partnership bringing together world-leading plasma companies to focus on developing and delivering a hyperimmune immunoglobulin in the global fight against COVID-19.
:: Teva is actively looking through its range of products to determine if it can help provide any products that may be relevant in addressing acute and substantial need during the COVID-19 crisis.

 

Diagnostics
Rolling out diagnostics to detect whether patients are genuinely infected with the new coronavirus is a key step in preventing or slowing its spread. However, the rapid spread of COVID-19 has drastically increased the demand for testing kits around the world, especially in the United States and Europe, and governments are trying to ramp up their testing capacities.
:: AstraZeneca is accelerating the development of its diagnostic testing capabilities to scale-up screening and is also working in partnership with governments on existing screening programmes to supplement testing.
:: Bayer is making more than 40 virus diagnostics devices available from its research operations to scale up Germany’s COVID-19 analysis by several thousand tests daily.
:: Novo Nordisk scientists are working in R&D laboratories to boost Denmark’s COVID-19 testing capacity.
:: Roche announced that the FDA issued an Emergency Use Authorization for its diagnostic kit cobas® SARS-CoV-2 Test, advancing coronavirus testing to meet urgent medical needs. Roche is committed to delivering as many tests as possible and is going to the limits of production capacity.
:: Shionogi and Micro Blood Science (MBS) entered into a partnership to develop COVID-19 antibody-test kits using MBS’ original technology, including unique trace-blood collection devices.
:: Takeda is partnering with public entities and other pharmaceutical companies through the Innovative Medicines Initiative (IMI) in Europe to leverage collective expertise in the hope of developing diagnostics for COVID-19 as well as inhibitors to help prevent future outbreaks.

In addition to the individual contributions companies are already making, a consortium of life sciences companies announced an important collaboration on March 25 to accelerate the development, manufacture, and delivery of vaccines, diagnostics, and treatments for COVID-19, alongside the Gates Foundation. Co-chaired by Vas Narasimhan, chief executive officer of Novartis, the consortium seeks out to accelerate solutions to this pandemic.

 

Companies participating in the collaboration include BD, bioMérieux, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck (known as MSD outside the U.S. and Canada), Merck KGaA, Novartis, Pfizer, and Sanofi…

CEPI publishes analysis of COVID-19 vaccine development landscape

Milestones :: Perspectives :: Research

 

CEPI publishes analysis of COVID-19 vaccine development landscape
115 vaccine candidates identified, 5 of which lead have progressed into phase 1
Research by CEPI’s vaccine R&D team, published in Nature Reviews Drug Discovery, has identified 115 COVID-19 vaccines in development.
The CEPI team have been continuously maintaining an overview of the global landscape of COVID-19 vaccine development activity.
From February, 2020, onwards, the team studied the landscape of COVID-19 vaccine candidates by using internal and external data sources, including vaccine development programmes reported through the WHO’s authoritative and continually updated list; information from calls for proposals and direct communications with vaccine developers and partners; clinical trial and funders databases, publicly available literature; and media and press releases.

Wide range of vaccine technology being tested
As of April 8, 2020, 115 vaccine candidates are in varying stages of development. 78 of which are confirmed as active and 37 are unconfirmed (development status cannot be determined from publicly available or proprietary information sources). The study showed that a wide range of technology platforms are being assessed, including traditional and novel approaches.
Most of the active projects are in exploratory or preclinical stages. However, 5 candidates have recently moved into clinical development, including mRNA-1273 (Moderna), Ad5-nCoV (CanSino Biologicals), INO-4800 (Inovio), LV-SMENP-DC and pathogen-specific aAPC (Shenzhen Geno-Immune Medical Institute). Notably, Moderna was able to start clinical testing of its mRNA-based vaccine just 63 days after sequence identification.
The paper also points out that public information on the specific SARS-CoV-2 antigen(s) used in vaccine development is limited and that most vaccine candidates for which information is available aim to induce neutralizing antibodies against the viral surface protein referred to as the “spike protein”.

The lead developers      
56 (72%) of 78 the confirmed active vaccine candidates are being developed by private or industry developers. 22 (28%) of projects being led by academic, public sector, and other not-for-profit organizations.
Although a number of large multinational vaccine developers (such as Janssen, Sanofi, Pfizer and GlaxoSmithKine) have engaged in COVID-19 vaccine development, many of the lead developers were identified as small and/or inexperienced in large-scale vaccine manufacture.

Geographical distribution of vaccine R&D
Of the confirmed active vaccine candidates, 36 (46%) developers are in North America, 14 (18%) in China, 14 (18%) in Asia (excluding China) and Australia, and 14 (18%) in Europe.
Lead developers of active COVID-19 vaccine candidates are distributed across 19 countries, which collectively account for over three-quarters of the global population.
No public information on vaccine development activity in Africa or Latin America is available. However, it was noted that vaccine manufacturing capacity and regulatory frameworks exist in these regions.

Insights
The authors of this paper stressed that strong international coordination and co-operation among vaccine developers, regulators, policymakers, funders, public health bodies and governments will be needed to ensure safe and effective vaccine can be manufactured in sufficient quantities and made globally accessible.
They also highlighted that CEPI maintains a dynamic approach to the management of its vaccine portfolio and is committed to making its enabling science resources available globally.
Finally, the authors urged the global vaccine community to collectively mobilise the technical and financial support needed to successfully address the COVID-19 pandemic through a global vaccination programme. Earlier this year, CEPI published an estimate that $2 billion would be required to develop a vaccine against COVID-19.

Emergencies – Coronavirus [COVID-19]

EMERGENCIES

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

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

:::::

Situation report – 81 [WHO]

Novel Coronavirus (COVID-19)
10 April 2020
[Excerpts]
SITUATION IN NUMBERS
Globally
1 521 252 confirmed (85 054)
92 798 deaths (7277)

European Region
799 696 confirmed (40 035)
66 213 deaths (4697)

Region of the Americas
493 173 confirmed (38 463)
17 038 deaths (2264)

Western Pacific Region
117 247 confirmed (1395)
3978 deaths (34)

Eastern Mediterranean Region
88 657 confirmed (3307)
4607 deaths (148)

South-East Asia Region
12 978 confirmed (1402)
569 deaths (101)

African Region
8789 confirmed (452)
382 deaths (33)

WHO RISK ASSESSMENT
Global Level – Very High

HIGHLIGHTS
:: No new country/territory/area reported cases of COVID-19 in the past 24 hours.

:: Dr. Bruce Aylward, Special Adviser to WHO’s Director-General, speaking of his recent mission to Spain at a press briefing yesterday, highlighted the need for countries to understand that the virus can overwhelm even the most robust health systems, resulting in the need to entirely reconfigure health sectors in response. Find more about Dr. Aylward’s recent fact-finding mission to Spain here.

: OpenWHO, a web-based learning platform, has launched a new online course Introduction to Go.Data – Field data collection, chains of transmission and contact follow-up. The Go.Data tool supports outbreak investigation, focusing on field data collection, contact tracing and visualisation of chains of transmission. It is available to WHO staff around the world, Member States and partners. For more information, please see here.

:: As the number of cases continues to climb in Europe, two new WHO tools launched today will help health planners in the European Region prepare for the rapidly increasing number of patients with COVID-19 requiring acute and intensive care in hospitals. For more details, please see here.

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

Ebola – DRC+

Emergencies

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

Ebola Outbreak in DRC 87: 07 April 2020
[Excerpts]
Situation Update WHO Health Emergencies Programme Page 2
Since 17 February, there have been no new cases of Ebola virus disease (EVD) reported from Democratic Republic of the Congo. This is a positive sign; however, there is still a high risk of re-emergence of EVD, and challenges related to limited resources, continued insecurity, population displacement in previous hotspots and limited access to some affected communities. It is essential to maintain surveillance and response activities…

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

::::::

New Ebola case confirmed in the Democratic Republic of the Congo
10 April 2020 News release
A new case of Ebola virus disease was confirmed today in the city of Beni in the Democratic Republic of the Congo (DRC).
“While not welcome news, this is an event we anticipated. We kept response teams in Beni and other high risk areas for precisely this reason,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General…
…The news of the confirmed case came minutes after the conclusion of a meeting of the International Health Regulations Emergency Committee on Ebola in DRC. The Emergency Committee will reconvene next week in order to re-evaluate their recommendations in light of this new information…

 

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

POLIO

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 08 April 2020
Summary of new viruses this week (AFP cases and ES positives):
:: Pakistan: one WPV1 case and 16 WPV1 positive environmental samples
:: Ghana: three cVDPV2 positive environmental samples
:: Central African Republic – one cVDPV2 case
:: Burkina Faso: two cVDPV2 cases
:: Côte d’Ivoire: one cVDPV2 case and two cVDPV2 positive environmental samples

::::::

Statement of the Twenty-Fourth IHR Emergency Committee
8 April 2020 Statement
The Twenty-fourth meeting of the Emergency Committee under the International Health Regulations (2005) (IHR) on the international spread of poliovirus was convened by the Director General on 26 March 2020 with committee members only attending via teleconference, supported by the WHO Secretariat…
Reports were received from Afghanistan, Burkina Faso, Central African Republic, Cote d’Ivoire, Democratic Republic of Congo (DR Congo), Ethiopia, Ghana, Pakistan, and Philippines.
The Emergency Committee reviewed the data on wild poliovirus (WPV1) and circulating vaccine derived polioviruses (cVDPV).  The WHO Secretariat presented a report of progress for affected IHR States Parties subject to Temporary Recommendations.

Wild poliovirus
The Committee remains gravely concerned by the significant increase in WPV1 cases globally in 2019 and 2020, with 175 cases in 2019 compared to 33 in 2018, and already 32 cases as at 17 March 2020, compared to six for the same period in 2019, with no significant success yet in reversing this trend…

Vaccine derived poliovirus (VDPV)
The multiple circulating VDPV (cVDPV) outbreaks in four WHO regions (African, Eastern Mediterranean, South-east Asian and Western Pacific Regions) are very concerning, with two new countries reporting outbreaks since the last meeting (Malaysia and Burkina Faso).  Unlike historical experience, cross border spread of cVDPV2 has become quite common, with recent spread from Angola to DR Congo and Zambia, and from Chad and CAR to Cameroon, and from Ghana to Burkina Faso.  In addition, local emergences attributable to mOPV2 use have recently occurred in Togo, Chad and Ethiopia.
The Committee noted that the GPEI has published a strategy to address cVDPV2 outbreaks but was extremely concerned that the monovalent OPV2 stockpile was still depleted.  The Committee strongly supports the development and proposed Emergency Use Listing of the novel OPV2 vaccine which should become available mid-2020, and which it is hoped will result in no or very little seeding of further outbreaks.

Impact of COVID-19
The Committee noted the very recent policy guidance of the GPEI:
:: GPEI recommendations for countries during the COVID-19 pandemic. This document summarizes the recommendations from the Polio Oversight Board meeting on 24 March 2020 which calls for postponement of both preventive and outbreak response campaigns, while ensuring surveillance and nOPV2 development and roll out plans continue in full.
:: The COVID-19 Polio programme continuity plan. The operational guide was developed in collaboration with the regional polio eradication teams and the GPEI Partners to ensure essential GPEI functions continue, polio programme personnel and staff are kept safe, and to plan for a fast and effective resumption of polio eradication activities including supplementary immunization activities as soon as the public health situation with COVID-19 allows.
The Committee is extremely concerned about the impact of the COVID-19 pandemic on the risk of heightened transmission of polio and consequently the potential for international spread and significant reversal of polio eradication.     

Conclusion
The Committee unanimously agreed that the risk of international spread of poliovirus remains a Public Health Emergency of International Concern (PHEIC) and recommended the extension of Temporary Recommendations for a further three months.  However noting that some if not many international borders are closed to prevent  international spread of COVID-19, State Parties may not currently be able to enforce the Temporary Recommendations in all places. The Committee strongly urges countries subject to these recommendations to maintain a high state of readiness to implement them as soon as possible ensuring the continued safety of travelers as well as health professionals .  The Committee recognizes the concerns regarding the lengthy duration of the polio PHEIC, but concludes that the current situation is extraordinary, with clear ongoing risk of international spread and ongoing need for coordinated international response…

…Based on the current situation regarding WPV1 and cVDPV, and the reports provided by affected countries, the Director-General accepted the Committee’s assessment and on 7 April 2020 determined that the situation relating to poliovirus continues to constitute a PHEIC, with respect to WPV1 and cVDPV.  The Director-General endorsed the Committee’s recommendations for countries meeting the definition for ‘States infected with WPV1, cVDPV1 or cVDPV3 with potential risk for international spread’, ‘States infected with cVDPV2 with potential risk for international spread’ and for ‘States no longer infected by WPV1 or cVDPV, but which remain vulnerable to re-infection by WPV or cVDPV’ and extended the Temporary Recommendations under the IHR to reduce the risk of the international spread of poliovirus, effective 7 April 2020.

 

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

WHO Grade 3 Emergencies [to 11 Apr 2020]

Democratic Republic of the Congo
:: Ebola Outbreak in DRC 87: 07 April 2020
[See Ebola above for detail]

Mozambique floods
:: World Health Organization: 17 cases of COVID-19 confirmed in Mozambique 09 April 2020

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

 

::::::

WHO Grade 2 Emergencies [to 11 Apr 2020]
Iraq
:: Iraq produces COVID-19 laboratory supplies to more rapidly test cases April 5, 2020

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

 

::::::

WHO Grade 1 Emergencies [to 11 Apr 2020]

Chad – No new digest announcements identified
Djibouti – No new digest announcements identified
Kenya – No new digest announcements identified
Mali – No new digest announcements identified
Namibia – viral hepatitis – No new digest announcements identified
Tanzania – No new digest announcements identified

 

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

UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: Syrian Arab Republic: COVID-19 Update No. 05 – 10 April 2020

Yemen
:: 08 April 2020 Yemen Humanitarian Update Issue 3 (March 2020)

 

::::::

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
CYCLONE IDAI and Kenneth – No new digest announcements identified
EBOLA OUTBREAK IN THE DRC – No new digest announcements identified

 

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

WHO & Regional Offices [to 11 Apr 2020]

WHO & Regional Offices [to 11 Apr 2020]
10 April 2020 News release
New Ebola case confirmed in the Democratic Republic of the Congo

8 April 2020 Statement
Statement of the Twenty-Fourth IHR Emergency Committee
{See Polio above for detail]

8 April 2020 Statement
Joint Leader’s statement – Violence against children: A hidden crisis of the COVID-19 pandemic

8 April 2020 Statement
WHO Timeline – COVID-19
This timeline is updated on an ongoing basis, in response to evolving events and common media queries.

7 April 2020 News release
WHO and partners call for urgent investment in nurses
Geneva – The Covid-19 pandemic underscores the urgent need to strengthen the global health workforce. A new report, The State of the World’s Nursing 2020, provides an in-depth look at the largest component of the health workforce. Findings identify important gaps in the nursing workforce and priority areas for investment in nursing education, jobs, and leadership to strengthen nursing around the world and improve health for all.

 

::::::

PPC: Call for comments by 14 May 2020: 9 April 2020
Preferred Product Characteristics for Vaccines against Enterotoxigenic Escherichia colipdf, 491kb
Draft Version for public consultation
Comment Form – ETEC-Vx PPCdoc, 97kb

 

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: COVID-19 pandemic expands reach in Africa 10 April 2020
As the number of COVID-19 cases in Africa continues to grow, more countries in the continent are seeing the virus spread to regions beyond the capital cities.
:: New Ebola case confirmed in the Democratic Republic of the Congo 10 April 2020
A new case of Ebola virus disease was confirmed today in the city of Beni in the Democratic Republic of the Congo (DRC).
:: Benin goes on digital offensive against COVID-19 09 April 2020
Cotonou, 9 April 2020 – After the first case of COVID-19 was announced in Benin on the 16 March, within four days, the West African nation had set up a range of digital platforms to help combat both the spread of the disease and what the World Health Organization (WHO) has called “infodemic” of misinformation around it.
:: COVID-19 cases top 10 000 in Africa 07 April 2020
The number of confirmed COVID-19 cases in Africa has risen to more than 10 000 and caused more than 500 deaths. While the virus was slow to reach the continent compared to other parts of the world, infection has grown exponentially in recent weeks and continues to spread.

WHO Region of the Americas PAHO
:: PAHO Director calls for protection of health workers in face of the advancing COVID19 pandemic in the region of the Americas (04/07/2020)
:: Amid COVID-19 pandemic, new WHO report urges greater investments in the nursing workforce (04/07/2020)

WHO South-East Asia Region SEARO
:: Countries in WHO South-East Asia Region need 1.9 million more nurses, midwives to achieve health for all 7 April 2020 News release SEARO

WHO European Region EURO
:: New WHO tools launched to help hospitals manage surge in COVID-19 patients 08-04-2020
:: Reconfiguring health systems vital to tackling COVID-19 08-04-2020
:: COVID-19 hotline in Romania provides up-to-date public advice with WHO support 08-04-2020
:: WHO calls on governments to invest in nurses for a healthy Europe 07-04-2020
:: New WHO/Europe tool for behavioural insights: critical to inform COVID-19 response 06-04-2020

WHO Eastern Mediterranean Region EMRO
:: Latest update on COVID-19
:: COVID-19 cases in Africa top 10 000 8 April 2020

:: Iraq produces COVID-19 laboratory supplies to more rapidly test cases 5 April 2020

WHO Western Pacific Region
:: Urgent need for investment in nursing 7 April 2020 News release Manila, Philippines
COVID-19 pandemic puts need for nurses into sharp relief

China CDC

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

 

National Health Commission of the People’s Republic of China
http://en.nhc.gov.cn/
News
April 11: Daily briefing on novel coronavirus cases in China
On April 10, 31 provincial-level regions on the Chinese mainland as well as the Xinjiang Production and Construction Corps reported 46 new cases of confirmed infections (42 imported cases and 4 indigenous cases, 3 in Guangdong province and 1 in Heilongjiang province).

Timeline of China releasing information on COVID-19 and advancing international cooperation
Updated: 2020-04-06
… Based on media reports and information from the National Health Commission, scientific research institutions and other departments, Xinhua News Agency sorted out the main facts China has taken in the global joint anti-virus efforts to timely release epidemic information, share prevention and control experience, and advance international exchanges and cooperation on epidemic response…

Continue reading

Announcements

Announcements

 

Paul G. Allen Frontiers Group    [to 11 Apr 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
Press Release
No new digest content identified.
 
 
BMGF – Gates Foundation  [to 11 Apr 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute    [to 11 Apr 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 11 Apr 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 11 Apr 2020]
http://cepi.net/
Latest News
CEPI publishes analysis of COVID-19 vaccine development landscape
115 vaccine candidates identified, 5 of which lead have progressed into phase 1
[See Milestones above for detail]
 
 
CEPI welcomes COVID-Zero initiative to fill R&D funding shortfall
09 Apr 2020
CEPI is a partner in the new COVID-Zero initiative, which aims to help raise at least $8 billion by the end of April to cover a global funding shortfall for vaccines, treatments and testing for coronavirus…
COVID-Zero is calling on business to form a coalition that can help bridge this funding shortfall and get our lives, businesses and economies back on track. The initiative is called COVID-Zero because by securing this funding, it aims to achieve zero deaths, zero new cases and zero lockdowns as soon as possible…
Belgium and Canada provide funding boost for CEPI’s COVID-19 vaccine research
06 Apr 2020
 
 Clinton Health Access Initiative, Inc. (CHAI)  [to 11 Apr 2020]
https://clintonhealthaccess.org/
News & Press Releases
No new digest content identified.
 
 
EDCTP    [to 11 Apr 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
9 April 2020
EDCTP and Africa CDC collaborate to develop capacity for outbreak and epidemic response in sub-Saharan Africa
Reliable epidemiological data is often unavailable or severely limited in resource-limited settings in Africa. This knowledge gap is further aggravated by a shortage of skilled personnel in epidemiology and biostatistics to efficiently monitor, analyse and interpret epidemiological data to inform…
…On 10 April 2020, the European and Developing Countries Clinical Trials Partnership (EDCTP) and the Africa Centres for Disease Control and Prevention (Africa CDC) will launch a call for proposals with a total call budget of €5 million. The aim is to establish an African cohort of epidemiologists by supporting institutions in sub-Saharan Africa and Europe that provide Master’s degree training in epidemiology and biostatistics, as part of Africa CDC’s framework for public health workforce development…
 
 
Emory Vaccine Center    [to 11 Apr 2020]
http://www.vaccines.emory.edu/
No new digest content identified.
 
 
European Medicines Agency  [to 11 Apr 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Guidance on regulatory requirements in the context of the COVID-19 pandemic
Last updated: 10/04/2020
 
 
Press release: Update on EU actions to support availability of medicines during COVID-19 pandemic
Last updated: 10/04/2020
Press release: EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines
Last updated: 09/04/2020
Press release: Global regulators stress need for robust evidence on COVID-19 treatments
Last updated: 09/04/2020
News: Global regulators discuss observational studies of real world data for COVID-19 medicines
Last updated: 07/04/2020
 
 
European Vaccine Initiative  [to 11 Apr 2020]
http://www.euvaccine.eu/news-events
Latest News
No new digest content identified.
 
 
FDA [to 11 Apr 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
April 10, 2020 – Coronavirus (COVID-19) Update: Daily Roundup April 10, 2020
 
April 10, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes Blood Purification Device to Treat COVID-19
 
 
Fondation Merieux  [to 11 Apr 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.
 
 
 
Gavi [to 11 Apr 2020]
https://www.gavi.org/
Top Stories
COVID-19: Gavi steps up response to pandemic
:: Up to US$ 200 million available to help lower-income countries to quickly respond to pandemic; US$ 29 million approved as first tranche of funds to protect health workers and boost surveillance, testing
:: More than 21,500 cases and 681 deaths have been officially reported in 66 lower-income countries; true numbers likely to be much higher
:: Seth Berkley: “Health systems across the developing world face their biggest test in living memory, and Gavi is helping them to meet it”
Geneva, 9 April 2020 – Gavi, the Vaccine Alliance, will provide US$ 29 million in urgent initial funding to 13 lower-income countries to support their response to COVID-19, helping them to protect health care workers with personal protective equipment (PPE), perform vital surveillance and training, and fund diagnostic tests. There are further requests or interest from 21 countries, meaning more support from a total of up to US$ 200 million is likely to be approved in the coming days and weeks. This early funding is designed to provide immediate support until more substantial support from other sources is unlocked…
 
 
GHIT Fund   [to 11 Apr 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 11 Apr 2020]
https://www.theglobalfund.org/en/news/
News & Stories
News
Global Fund Partners Unite to Fight
09 April 2020
GENEVA – The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria today unanimously approved a new response mechanism to support countries to respond to COVID-19 and mitigate the impact on programs to fight HIV, TB, malaria and systems for health, effectively doubling the amount of available funding to up to US$1 billion.
The COVID-19 Response Mechanism authorizes funding of US$500 million and comes in addition to up to US$500 million in grant flexibilities that were announced by the Global Fund on 4 March and are already being implemented by 54 countries…
 
Funding Model
COVID-19 Response: Technical Guidance
09 April 2020
 
Sourcing & Management of Health Products
Guidance for Countries Selecting a Logistics Management Information System
07 April 2020
 
Sourcing & Management of Health Products
Opportunity for Evaluation of Diagnostic Products
07 April 2020
 
Sourcing & Management of Health Products
COVID-19 Response: Impact on Health Product Supply
07 April 2020
 
Voices
The Threat to Africa
07 April 2020
By Peter Sands, Executive Director of the Global Fund
…Unless extremely fast action is taken, the prospect of an imminent catastrophe in Africa will become real. Current confirmed cases and deaths are still relatively low in Africa, and the continent may be four to six weeks behind Europe’s outbreak. But the trajectory and impact of Covid-19 could be far worse – much harder to contain and causing far more death and damage to communities…
 
 
Hilleman Laboratories   [to 11 Apr 2020]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 11 Apr 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.
 
 
IAVI  [to 11 Apr 2020]
https://www.iavi.org/newsroom
Press Releases
No new digest content identified.
 
 
International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
Global regulators stress need for robust evidence on COVID-19 treatments
International regulators have published a report today highlighting their considerations on the development of potential COVID-19 therapeutics, clinical trials and compassionate use programmes. The report presents the outcomes of a workshop on COVID-19 therapeutic medicine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).
 
 
Second regulatory COVID-19 workshop – meeting report_April 2020
The following represents generally agreed positions among global regulators in attendance.
Regulators emphasised that within the current COVID-19 disease pandemic, no specific medicinal product has yet clearly demonstrated efficacy. With the threat affecting all countries, regulators expressed the need for collecting robust and reliable evidence to establish safety and efficacy for the proposed medicines, so as to serve the patients’ needs in the fastest fashion possible.

Various therapeutic candidates have been prioritised for inclusion in large well-designed randomized clinical trials aimed at evaluating the treatment of COVID-19 patients. They include, based on a WHO-initiated landscape analysis of therapeutics, remdesivir, lopinavir/ritonavir with or without interferon–𝛽, and chloroquine/hydroxychloroquine. Other antivirals (e.g. monoclonal antibodies, hyperimmune sera) and immunomodulating agents such as IL-6 and IL-1 inhibitors are likewise considered for development.

However, for all these medicines, the pharmacological rationale, potential benefits and risks even in context of clinical trials, e.g. increased risk of infection with use, require careful attention.

It was agreed that randomised controlled trials (RCTs) with an appropriate control arm (i.e. not including antivirals or immune modulators), appropriately designed to generate data that meet regulatory requirements for approval, could lead to timely regulatory decisions, and could guide clinicians in defining promptly the best treatment options for COVID-19.

To this effect, multi-arm clinical studies investigating different agents simultaneously have the potential to deliver results as rapidly as possible across a range of therapeutic options, according to the same evaluation criteria.

Participants acknowledged that small studies or compassionate use programmes are unlikely to be able to generate the required level of evidence to allow clear-cut recommendations.

Nevertheless, regulators concurred that compassionate use programmes, which allow access to potential therapies for patients in need, have a beneficial public health impact on the pandemic and should be allowed, as long as they do not pose a threat to clinical trials recruitment.

Regulators expressed concern due to the multitude of ongoing trials and access programmes, which may lead to shortages of investigational products, and recommended this to be carefully monitored. It was acknowledged that preservation of access to medicines approved in indications other than COVID-19 and used as well in COVID-19 investigations might be critical in these situations, posing ethical issues of equitable distribution.

It was agreed that as clinical trial data emerge from relevant studies, sharing of information would be of uttermost importance globally. This group will reconvene within 2-3 months to take stock of the evolving therapeutic landscape.
 
 
International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
IGBA Contributes to Global Discussion on Tailored Clinical Biosimilar Development with New Peer-Reviewed Scientific Paper
(10 April 2020)
The International Generic and Biosimilar medicines Association (IGBA), which represents global manufacturers of generic and biosimilar medicines, today announces the publication of its first peer-reviewed scientific paper on biosimilar medicines development: The Path Towards a Tailored Clinical Biosimilar Development (Biodrugs).

COVID-19: IGBA calls for urgent priority designation for medicines at custom controls and for cargo and freight
(6 April 2020)
The International Generic and Biosimilar medicines Association (IGBA), which represents global manufacturers of generic and biosimilar medicines, today requests urgent action by all governments to designate all medicines as PRIORITY ESSENTIAL PRODUCTS, including all critical goods needed to manufacture them…
 
 
IFFIm
http://www.iffim.org/
Press Releases
IFFIm stands ready to support COVID-19 vaccines
09 Apr 2020
… We already have a proven and trusted financing tool to make this possible: IFFIm, the International Finance Facility for Immunisation. Since its first Vaccine Bond issuance in 2006, IFFIm has enabled Gavi, the Vaccine Alliance to pay for pressing immunisation programmes, as well as for polio eradication, vaccine stockpiles and health system strengthening.
Now, subject to Gavi approval and additional donor pledges, IFFIm could be put to work to raise fast, flexible financing on a large scale to fund the development a COVID-19 vaccine as well as its rapid deployment to affected countries once available.

So far, ten countries have committed to pay out more than US$ 6.5 billion to IFFIm over 10 to 23 years. Against those pledges, IFFIm’s Vaccine Bonds have raised about $6.1 billion from private sector investors around the world and provided $2.6 billion of immediately available funding for Gavi. IFFIm then pays back those investors at a competitive rate of return…
 
 
 IFRC   [to 11 Apr 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.
 
 
IVAC  [to 11 Apr 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
No new digest content identified.
 
 
IVI   [to 11 Apr 2020]
http://www.ivi.int/
Selected IVI News & Announcements
No new digest content identified.
 
 
JEE Alliance  [to 11 Apr 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 11 Apr 2020]
http://www.msf.org/
Latest [Selected Announcements]
Yemen
Authorities in Yemen must do all they can to facilitate COVID-19 response
Press Release 10 Apr 2020
 
 
Coronavirus disease COVID-19
Spain must urgently improve the care of elderly in COVID-19 response
Press Release 9 Apr 2020
 
 
Coronavirus disease COVID-19
MSF responds to COVID-19 in Lebanon
Project Update 9 Apr 2020
 
 
 
National Vaccine Program Office – U.S. HHS  [to 11 Apr 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC 2020 Meetings
June 9-10, 2020 NVAC Meeting
September 23-24, 2020 Meeting (Virtual)
 
 
NIH  [to 11 Apr 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH begins study to quantify undetected cases of coronavirus infection
April 10, 2020 — Blood samples from healthy volunteers needed to inform public health decision making.

NIH clinical trial of hydroxychloroquine, a potential therapy for COVID-19, begins
April 9, 2020 — Study is enrolling hospitalized adults with COVID-19.
 
 
PATH  [to 11 Apr 2020]
https://www.path.org/media-center/
Selected Announcements
No new digest content identified.
 
 
Sabin Vaccine Institute  [to 11 Apr 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.
 
 
UNAIDS [to 11 Apr 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
9 April 2020
A tribute to Maeve Kennedy Townsend McKean

9 April 2020
When will men stop thinking that women’s bodies are their property?

8 April 2020
New innovations map to strengthen the response to COVID-19

8 April 2020
Ensuring that people living with HIV in the Philippines have access to treatment during COVID-19

7 April 2020
Living with HIV under lockdown

6 April 2020
Supporting transgender people during the COVID-19 pandemic

6 April 2020
HIV knowledge greater among women with higher incomes
 
 
UNICEF  [to 11 Apr 2020]
https://www.unicef.org/media/press-releases
Press release
New Ebola death confirmed in the DRC as country was close to declaring end of epidemic
10/04/2020

Statement
Don’t let children be the hidden victims of COVID-19 pandemic
Ninety-nine per cent of the world’s children live with some form of pandemic-related movement restrictions; Sixty per cent live in countries with full or partial lockdowns
09/04/2020

Press release
Children’s story book released to help children and young people cope with COVID-19
08/04/2020

Press release
UNICEF providing supplies to combat COVID-19 and support integrated response in Venezuela
08/04/2020

Press release
COVID-19: UNICEF Spain makes first delivery of health supplies to fight Coronavirus
08/04/2020

Press release
Debt relief for the poorest countries critical in fight against COVID-19
Statement by UNICEF Executive Director Henrietta Fore
07/04/2020

Statement
Launch of Global Multi-Religious Faith-in-Action Covid-19 Initiative
Faith and Positive Change for Children, Families and Communities
07/04/2020

Press release
UNICEF is providing supplies and technical support to fight COVID-19 in Lebanon
06/04/2020

Press release
Urgent need to secure learning for children across South Asia
06/04/2020
 
 
Unitaid  [to 11 Apr 2020]
https://unitaid.org/#en
Unitaid is a global development agency, hosted by the World Health Organization and its major donors are France, the United Kingdom, Brazil, Norway, Chile, the Republic of Korea, Spain and the Bill & Melinda Gates Foundation.
No new digest content identified.
 
 
Vaccination Acceptance Research Network (VARN)  [to 11 Apr 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.
 
 
Vaccine Confidence Project  [to 11 Apr 2020]
http://www.vaccineconfidence.org/
Latest News & Archive
No new digest content identified.
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 11 Apr 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
Coronavirus Updates
Frequently Asked Questions about Coronavirus Disease 2019 (COVID-19)
Last Updated: March 19, 2020
Get some fast facts about the coronavirus from CHOP and the CDC. The CDC will provide updated information as it becomes available.
 
 
Wellcome Trust  [to 11 Apr 2020]
https://wellcome.ac.uk/news
News | 6 April 2020
Wellcome Trust building to become respite centre for local NHS staff
 
 
The Wistar Institute   [to 11 Apr 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.
 
 
WFPHA: World Federation of Public Health Associations  [to 11 Apr 2020]
https://www.wfpha.org/
Latest News
World Health Day
Tuesday, 07 April 2020
It’s World Health Day! It is the day to celebrate the work of Public Health Professionals, Nurses, Midwives, Doctors, and All Health Workers
 
 
World Organisation for Animal Health (OIE)   [to 11 Apr 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

::::::
 
ARM [Alliance for Regenerative Medicine]  [to 11 Apr 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.
 
 
BIO    [to 11 Apr 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 11 Apr 2020]
http://www.dcvmn.org/
News
No new digest content identified.
 
 
IFPMA   [to 11 Apr 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA Backgrounder – COVID-19
03 April 2020
[See COVID-19 above for detail]
 
 
PhRMA    [to 11 Apr 2020]
http://www.phrma.org/
Selected Press Releases, Statements
To the millions affected by COVID-19
Stephen J. Ubl and Giovanni Caforio, M.D.   |     April 9, 2020

Today, in the midst of this global pandemic, our industry is doing what we are uniquely positioned to do: testing new and existing treatments to determine what might work against COVID-19 and developing new vaccines to prevent it…
Merck’s Dr. Julie Gerberding on the threat of antimicrobial resistance and COVID-19
Andrew Powaleny   |     April 6, 2020
We recently spoke with Dr. Julie Gerberding, executive vice president and chief patient officer at Merck, about AMR and the biopharmaceutical industry’s efforts to combat the COVID-19 pandemic.
 
 
Industry Watch
::  Lilly Begins Clinical Testing of Therapies for COVID-19 Apr 10, 2020
:: Pfizer Advances Battle Against COVID-19 on Multiple Fronts
. Anti-viral compounds show activity against SARS-CoV-2 in preclinical screening
. Pfizer and BioNTech enter into collaboration agreement to co-develop potential COVID-19 vaccine
. Company shares additional data and analysis of azithromycin
. Launch of two new studies to provide insights on the interaction between S. pneumoniae and SARS-CoV-2
. Pfizer explores studies of JAK inhibitor tofacitinib in patients with COVID-19-related pneumonia
April 09, 2020

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

Studies Using Randomized Trial Data to Compare Nonrandomized Exposures

Annals of Internal Medicine
7 April 2020 Vol: 172, Issue 7
http://annals.org/aim/issue

 

Understanding Clinical Research |7 April 2020
Studies Using Randomized Trial Data to Compare Nonrandomized Exposures
Catharine B. Stack, PhD; Anne R. Meibohm, PhD; Joshua M. Liao, MD, MSc; Eliseo Guallar, MD, DrPH
Researchers frequently use data collected in randomized controlled trials to target questions that are beyond the scope of the original trial. For example, trial data may be used to explore the effects on outcomes of an exposure collected during the trial that was not the randomized intervention. Although such data originate from a randomized trial, the analyses do not have the protection from bias that randomization provides. Successful randomization tends to balance observed and unobserved characteristics between study groups. Comparisons of nonrandomized exposures, even when done using trial data, can be biased and require analytic approaches commonly used for observational…

Valuing the cost of improving Chilean primary vaccination: a cost minimization analysis of a hexavalent vaccine

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 11 Apr 2020)

 

Valuing the cost of improving Chilean primary vaccination: a cost minimization analysis of a hexavalent vaccine
The phased withdrawal of oral polio vaccine (OPV) and the introduction of inactivated poliovirus vaccine (IPV) is central to the polio ‘end-game’ strategy.
Authors: Ignacio Olivera, Carlos Grau, Hugo Dibarboure, Juan Pablo Torres, Gustavo Mieres, Luis Lazarov, Fabián P. Alvarez and Juan Guillermo López Yescas
Citation: BMC Health Services Research 2020 20:295
Content type: Research article
Published on: 9 April 2020

Health and economic burden of respiratory syncytial virus (RSV) disease and the cost-effectiveness of potential interventions against RSV among children under 5 years in 72 Gavi-eligible countries

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 11 Apr 2020)

 

Health and economic burden of respiratory syncytial virus (RSV) disease and the cost-effectiveness of potential interventions against RSV among children under 5 years in 72 Gavi-eligible countries
Respiratory syncytial virus (RSV) frequently causes acute lower respiratory infection in children under 5, representing a high burden in Gavi-eligible countries (mostly low-income and lower-middle-income). Sin…
Authors: Xiao Li, Lander Willem, Marina Antillon, Joke Bilcke, Mark Jit and Philippe Beutels
Citation: BMC Medicine 2020 18:82
Content type: Research article
Published on: 6 April 2020

Vaccination coverage rates and predictors of HPV vaccination among eligible and non-eligible female adolescents at the Brazilian HPV vaccination public program

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 11 Apr 2020)

 

Vaccination coverage rates and predictors of HPV vaccination among eligible and non-eligible female adolescents at the Brazilian HPV vaccination public program
Since March 2014, the quadrivalent HPV vaccine has been incorporated into the Brazilian Unified Health Care System and began to be offered, without direct costs, for girls from 9 to 13 years of age. Older fema…
Authors: Alexandre Faisal-Cury, Renata Bertazzi Levy, Maria Fernanda Tourinho, Alexandre Grangeiro and José Eluf-Neto
Citation: BMC Public Health 2020 20:458
Content type: Research article
Published on: 6 April 2020

Exploiting antimicrobial resistance : Better knowledge of resistance mechanisms can inform the search for and development of new antibiotics

EMBO Reports
Volume 21 Issue 4 3 April 2020
https://www.embopress.org/toc/14693178/current

 

Science & Society 11 March 2020
Exploiting antimicrobial resistance : Better knowledge of resistance mechanisms can inform the search for and development of new antibiotics
Marc Ouellette, Arijit Bhattacharya
Antibiotic resistance is a grave threat for public health. Understanding the mechanisms of resistance could lead to new drugs and therapeutic strategies against resistant pathogens.

The spread of the COVID‐19 coronavirus : Health agencies worldwide prepare for the seemingly inevitability of the COVID‐19 coronavirus becoming endemic

EMBO Reports
Volume 21 Issue 4 3 April 2020
https://www.embopress.org/toc/14693178/current

 

Science & Society 17 March 2020 Free Access
The spread of the COVID‐19 coronavirus : Health agencies worldwide prepare for the seemingly inevitability of the COVID‐19 coronavirus becoming endemic
Philip Hunter
While it is too late to confine the COVID‐19 coronovirus outbreak to China, a wealth of data spurs epidemiological and vaccine research.

Promoting equity in immunization coverage through supply chain design in Pakistan

Gates Open Research
https://gatesopenresearch.org/browse/articles
[Accessed 11 Apr 2020]

 

Method Article metrics AWAITING PEER REVIEW
Promoting equity in immunization coverage through supply chain design in Pakistan [version 1; peer review: awaiting peer review]
Mariam Zameer, Nora Phillips-White, Olamide Folorunso, Rachel Belt, Hamidreza Setayesh, Naeem Asghar, Arshad Chandio
Peer Reviewers Invited
Funders: Bill and Melinda Gates Foundation, UNICEF
PUBLISHED 06 Apr 2020
Abstract
To improve equity in immunization coverage, potent immunization products must be available in the communities in which low coverage rates persist. Most supply side investments are focused on replacing or establishing new health facilities to improve access to immunization. However, supply chain design must be improved to ensure that potent vaccines are available at all facilities to promote immunization equity. We used the supply chain design process in Pakistan as an opportunity to conceptualize how supply chains could impact equity outcomes. This paper outlines our approach and key considerations for assessing supply chain design as a contributing factor in achieving equitable delivery of immunization services.
We conducted a supply chain analysis based on sub-national supply chain and immunization coverage at district level. Supply chain metrics included cold chain coverage and distances between vaccination sites and storage locations. Immunization coverage metrics included the third-dose diphtheria- tetanus-pertussis (DTP3) vaccination rate and the disparity in DTP3 coverage between urban and rural areas. All metrics were analyzed at the district level. Despite data limitations, triangulation across these metrics provided useful insights into the potential contributions of supply chain to equitable program performance at the district level within each province. Overall, our analysis identified supply chain gaps, highlighted supply chain contributions to program performance and informed future health system investments to prioritize children unreached by immunization services.

Fighting against the common enemy of COVID-19: a practice of building a community with a shared future for mankind

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 11 Apr 2020]

 

Commentary
Fighting against the common enemy of COVID-19: a practice of building a community with a shared future for mankind
Authors: Xu Qian, Ran Ren, Youfa Wang, Yan Guo, Jing Fang, Zhong-Dao Wu, Pei-Long Liu and Tie-Ru Han
7 April 2020
Abstract
The outbreak of coronavirus disease 2019 (COVID-19) has caused more than 80 813 confirmed cases in all provinces of China, and 21 110 cases reported in 93 countries of six continents as of 7 March 2020 since middle December 2019. Due to biological nature of the novel coronavirus, named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with faster spreading and unknown transmission pattern, it makes us in a difficulty position to contain the disease transmission globally. To date, we have found it is one of the greatest challenges to human beings in fighting against COVID-19 in the history, because SARS-CoV-2 is different from SARS-CoV and MERS-CoV in terms of biological features and transmissibility, and also found the containment strategies including the non-pharmaceutical public health measures implemented in China are effective and successful. In order to prevent a potential pandemic-level outbreak of COVID-19, we, as a community of shared future for mankind, recommend for all international leaders to support preparedness in low and middle income countries especially, take strong global interventions by using old approaches or new tools, mobilize global resources to equip hospital facilities and supplies to protect noisome infections and to provide personal protective tools such as facemask to general population, and quickly initiate research projects on drug and vaccine development. We also recommend for the international community to develop better coordination, cooperation, and strong solidarity in the joint efforts of fighting against COVID-19 spreading recommended by the joint mission report of the WHO-China experts, against violating the International Health Regulation (WHO, 2005), and against stigmatization, in order to eventually win the battle against our common enemy — COVID-19.

Novel Coronavirus Infection in Hospitalized Infants Under 1 Year of Age in China

JAMA
April 7, 2020, Vol 323, No. 13, Pages 1223-1324
http://jama.jamanetwork.com/issue.aspx

 

Research Letter
Novel Coronavirus Infection in Hospitalized Infants Under 1 Year of Age in China
Min Wei, MD; Jingping Yuan, MD, PhD; Yu Liu, PhD; et al.
free access has active quiz has multimedia has audio
JAMA. 2020;323(13):1313-1314. doi:10.1001/jama.2020.2131
This study characterizes the demographic, epidemiologic, and clinical characteristics of hospitalized infants diagnosed with coronavirus disease 2019 infection between December 8, 2019, and February 6, 2020, in China.

Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in ChinaSummary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention

JAMA
April 7, 2020, Vol 323, No. 13, Pages 1223-1324
http://jama.jamanetwork.com/issue.aspx

 

Viewpoint
Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in ChinaSummary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention
Zunyou Wu, MD, PhD; Jennifer M. McGoogan, PhD
free access has active quiz has audio
JAMA. 2020;323(13):1239-1242. doi:10.1001/jama.2020.2648
This Viewpoint summarizes key epidemiologic and clinical findings from all cases of coronavirus disease 2019 (COVID-19) reported through February 11, 2020, in mainland China, and case trends in response to government attempts to control and contain the infection.
Audio Interview: COVID-19 Update With NIAID’s Anthony Fauci, MD; March 6, 2020
Clinical Review Audio: Update on Coronavirus: March 6, 2020, by NIAID’s Anthony Fauci, MD

COVID-19 in Singapore—Current ExperienceCritical Global Issues That Require Attention and Action

JAMA
April 7, 2020, Vol 323, No. 13, Pages 1223-1324
http://jama.jamanetwork.com/issue.aspx

 

COVID-19 in Singapore—Current ExperienceCritical Global Issues That Require Attention and Action
John E. L. Wong, MBBS; Yee Sin Leo, MBBS, MPH; Chorh Chuan Tan, MBBS, PhD
free access has active quiz
JAMA. 2020;323(13):1243-1244. doi:10.1001/jama.2020.2467
This Viewpoint discusses public health measures implemented in Singapore to manage potential COVID-19 infection based on the country’s experience with SARS in 2003 and reviews critical information gaps necessary to help manage the outbreak, such as viral shedding patterns and optimal timing of antiviral treatment after exposure.

Preparing for the Most Critically Ill Patients With COVID-19The Potential Role of Extracorporeal Membrane Oxygenation

JAMA
April 7, 2020, Vol 323, No. 13, Pages 1223-1324
http://jama.jamanetwork.com/issue.aspx

 

Preparing for the Most Critically Ill Patients With COVID-19The Potential Role of Extracorporeal Membrane Oxygenation
Graeme MacLaren, MSc; Dale Fisher, MBBS; Daniel Brodie, MD
free access has active quiz has audio
JAMA. 2020;323(13):1245-1246. doi:10.1001/jama.2020.2342
This Viewpoint discusses the potential role of ECMO (extracorporeal membrane oxygenation) in the management of novel coronavirus disease 2019 (COVID-19) and cautions about the risk of overuse and the shortage of ECMO capability given the numbers of people infected if the technology is not appropriately utilized.
Clinical Review Audio: Update on Coronavirus: March 6, 2020, by NIAID’s Anthony Fauci, MD

Rotavirus Vaccination and Type 1 Diabetes Risk Among US Children With Commercial Insurance

JAMA Pediatrics
April 2020, Vol 174, No. 4, Pages 313-393
http://archpedi.jamanetwork.com/issue.aspx

 

Research Letter
Rotavirus Vaccination and Type 1 Diabetes Risk Among US Children With Commercial Insurance
Rachel M. Burke, PhD, MPH; Jacqueline E. Tate, PhD; Rebecca M. Dahl, MPH; et al.
JAMA Pediatr. 2020;174(4):383-385. doi:10.1001/jamapediatrics.2019.5513
This cohort study uses commercial insurance data to examine the association between rotavirus vaccination and type 1 diabetes incidence.

Magnitude and Functionality of the NS1-Specific Antibody Response Elicited by a Live-Attenuated Tetravalent Dengue Vaccine Candidate

Journal of Infectious Diseases
Volume 221, Issue 6, 15 March 2020
https://academic.oup.com/jid/issue/221/6

 

Editor’s Choice
Magnitude and Functionality of the NS1-Specific Antibody Response Elicited by a Live-Attenuated Tetravalent Dengue Vaccine Candidate
Mayuri Sharma, Dustin R Glasner, Heather Watkins, Henry Puerta-Guardo, Yoseph Kassa

A Third Dose of Measles-Mumps-Rubella Vaccine to Improve Immunity Against Mumps in Young Adults

Journal of Infectious Diseases
Volume 221, Issue 6, 15 March 2020
https://academic.oup.com/jid/issue/221/6

 

A Third Dose of Measles-Mumps-Rubella Vaccine to Improve Immunity Against Mumps in Young Adults
Waning of immunity is a major cause in the reemergence of mumps among vaccinated young adults. A third dose of the measles-mumps-rubella vaccine increases antibody levels and may protect against mumps for longer than previously assumed.
Patricia Kaaijk, Alienke J Wijmenga-Monsuur, Marlies A van Houten, Irene K Veldhuijzen, Hinke I ten Hulscher

Human Papillomavirus Vaccine Effectiveness Against HPV Infection: Evaluation of One, Two, and Three Doses

Journal of Infectious Diseases
Volume 221, Issue 6, 15 March 2020
https://academic.oup.com/jid/issue/221/6

 

Human Papillomavirus Vaccine Effectiveness Against HPV Infection: Evaluation of One, Two, and Three Doses
In this observational study of HPV vaccine effectiveness for prevention of vaccine-type prevalent infection, among women who had received their first vaccine dose at age ≤18 years, estimated vaccine effectiveness for 1, 2, and 3 doses was 92% or greater.
Lauri E Markowitz, Allison L Naleway, Nicola P Klein, Rayleen M Lewis, Brad Crane

Prioritarian principles for digital health in low resource settings

Journal of Medical Ethics
April 2020 – Volume 46 – 4
http://jme.bmj.com/content/current

 

Extended essay
Prioritarian principles for digital health in low resource settings (16 January, 2020)
Niall Winters, Sridhar Venkatapuram, Anne Geniets, Emma Wynne-Bannister
Abstract
This theoretical paper argues for prioritarianism as an ethical underpinning for digital health in contexts of extreme disadvantage. In support of this claim, the paper develops three prioritarian principles for making ethical decisions for digital health programme design, grounded in the normative position that the greater the need (of the marginalised), the stronger the moral claim. The principles are positioned as an alternative view to the prevailing utilitarian approach to digital health, which the paper argues is not sufficient to address the needs of the worst off. As researchers of digital health, we must ensure that the most globally marginalised are not overlooked by overtly technocentric implementation practices. Consequently, the paper concludes by advocating for use of the three principles to support stronger critical reflection on the ethics involved in the design and implementation of digital health programmes.

Next-generation influenza vaccines: opportunities and challenges

Nature Reviews Drug Discovery
Volume 19 Issue 4, April 2020
https://www.nature.com/nrd/volumes/19/issues/4

 

Review Article | 14 February 2020
Next-generation influenza vaccines: opportunities and challenges
Current seasonal influenza vaccines lack efficacy against drifted or pandemic virus strains, and the development of novel vaccines that elicit broader immunity represents a public health priority. Here, Nabel and colleagues discuss approaches to improve vaccine efficacy which harness new insights from influenza antigen structure and human immunity, highlighting major targets, vaccines in development and ongoing challenges.
Chih-Jen Wei, Michelle C. Crank[…] & Gary J. Nabel