Immunological considerations for SARS-CoV-2 human challenge studies

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Nature Reviews Immunology
Volume 20 Issue 12, December 2020
https://www.nature.com/nri/volumes/20/issues/12

 

Comment | 21 October 2020
Immunological considerations for SARS-CoV-2 human challenge studies
In this Comment article, Sandy Douglas and Adrian Hill discuss the immunological considerations associated with a risk–benefit analysis for controlled human infection models of SARS-CoV-2.
Alexander D. Douglas  & Adrian V. S. Hill

Measuring immunity to SARS-CoV-2 infection: comparing assays and animal models

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Nature Reviews Immunology
Volume 20 Issue 12, December 2020
https://www.nature.com/nri/volumes/20/issues/12

 

Review Article | 02 November 2020
Measuring immunity to SARS-CoV-2 infection: comparing assays and animal models
Are you new to virus research and trying to interpret the ever-expanding literature on immunity to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)? Here, the authors compare the different assays and animal models used to measure immunity to SARS-CoV-2 infection and reconcile differences in apparent potency of antibodies assessed in different assays.
David S. Khoury, Adam K. Wheatley […]  & Miles P. Davenport

Informing single-arm clinical trials with external controls

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Nature Reviews Drug Discovery
Volume 19 Issue 12, December 2020
https://www.nature.com/nrd/volumes/19/issues/12

 

Comment | 18 August 2020
Informing single-arm clinical trials with external controls
Randomized controlled trials are the accepted standard for evaluating investigational therapies, but such trials are sometimes not an option for reasons of ethics or feasibility. Here, we discuss opportunities to address evidence gaps by using historical clinical trial data and real-world data in external control arms for single-arm trials, as well as the associated challenges.
Ruthie Davi , Nirosha Mahendraratnam […]  & Rachel Sherman

A highly immunogenic and effective measles virus-based Th1-biased COVID-19 vaccine

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PNAS – Proceedings of the National Academy of Sciences of the United States of America
http://www.pnas.org/content/early/

 

Articles
A highly immunogenic and effective measles virus-based Th1-biased COVID-19 vaccine
Cindy Hörner, Christoph Schürmann, Arne Auste, Aileen Ebenig, Samada Muraleedharan, Kenneth H. Dinnon III, Tatjana Scholz, Maike Herrmann, Barbara S. Schnierle, Ralph S. Baric, and Michael D. Mühlebach
PNAS first published November 30, 2020. https://doi.org/10.1073/pnas.2014468117

Planning universal accessibility to public health care in sub-Saharan Africa

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PNAS – Proceedings of the National Academy of Sciences of the United States of America
http://www.pnas.org/content/early/

Planning universal accessibility to public health care in sub-Saharan Africa
Giacomo Falchetta, Ahmed T. Hammad, and Soheil Shayegh

 

PNAS first published November 30, 2020. https://doi.org/10.1073/pnas.2009172117
Significance
Achieving universal health care access is a key development priority and a target of Sustainable Development Goal number 3. The COVID-19 pandemic has only reinforced this urge. A rapid expansion of public, affordable health care infrastructure is particularly crucial in sub-Saharan Africa (SSA): communicable diseases are the first cause of death, infant mortality rates are above 5%, and lengthy journeys to health care facilities undermine the accessibility to basic health care for millions. This paper provides a planning-oriented, inequality-focused analysis of health care accessibility in SSA based on a state-of-the-art georeferenced database of public health care facilities. We devise a spatial optimization framework to identify the optimal location and required bed capacity of public health care facilities in the region.

The impact of shared decision making with patient decision aids on the rotavirus vaccination rate in children: A randomized controlled trial

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Preventive Medicine
Volume 141 December 2020
https://www.sciencedirect.com/journal/preventive-medicine/vol/141/suppl/C

 

Research article Abstract only
The impact of shared decision making with patient decision aids on the rotavirus vaccination rate in children: A randomized controlled trial
Sheng-Chieh Lin, Ka-Wai Tam, Jean Yu-Chun Yen, Meng-Che Lu, … Shih-Yen Chen
Article 106244

Public Health Ethics in a Pandemic

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Public Health Ethics
Volume 13, Issue 2, July 2020
http://phe.oxfordjournals.org/content/current

 

Editorial
Public Health Ethics in a Pandemic
Marcel Verweij, Angus Dawson
Public Health Ethics, Volume 13, Issue 2, July 2020, Pages 125–126, https://doi.org/10.1093/phe/phaa032
Extract
Ten years ago, we (re)published a historical pamphlet written during the 1665 Great Plague, by an anonymous inhabitant of London, entitled The Shutting Up Infected Houses (Anonymous, 2010; Verweij and Dawson, 2010). The author vividly argued against the practice of locking people up in their own houses as a means of preventing further disease transmission within the community. Many of those imprisoned in their own houses might not have been sick or infected at all. They were not treated as victims, but first and foremost, as a threat to others. The ‘quarantined’ families could only…

Vaccinating for Whom? Distinguishing between Self-Protective, Paternalistic, Altruistic and Indirect Vaccination

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Public Health Ethics
Volume 13, Issue 2, July 2020
http://phe.oxfordjournals.org/content/current

 

Original Articles: Ethics of vaccination
Vaccinating for Whom? Distinguishing between Self-Protective, Paternalistic, Altruistic and Indirect Vaccination
Steven R Kraaijeveld
Public Health Ethics, Volume 13, Issue 2, July 2020, Pages 190–200, https://doi.org/10.1093/phe/phaa005
Abstract
Preventive vaccination can protect not just vaccinated individuals, but also others, which is often a central point in discussions about vaccination. To date, there has been no systematic study of self- and other-directed motives behind vaccination. This article has two major goals: first, to examine and distinguish between self- and other-directed motives behind vaccination, especially with regard to vaccinating for the sake of third parties, and second, to explore some ways in which this approach can help to clarify and guide vaccination debates and policy. I propose conceiving of vaccination in terms of three basic elements: the vaccination decision-maker, the vaccine recipient and the primary beneficiary. I develop a taxonomy based on the relations between these elements to distinguish four kinds of vaccination: self-protective, paternalistic, altruistic and indirect. I finally discuss the case of human papillomavirus vaccine regulation for men and women to show how each kind of vaccination is associated with and raises specific ethical questions

Vaccination Policies: Between Best and Basic Interests of the Child, between Precaution and Proportionality

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Public Health Ethics
Volume 13, Issue 2, July 2020
http://phe.oxfordjournals.org/content/current

 

Vaccination Policies: Between Best and Basic Interests of the Child, between Precaution and Proportionality
Roland Pierik r.pierik@uva.nl
Public Health Ethics, Volume 13, Issue 2, July 2020, Pages 201–214, https://doi.org/10.1093/phe/phaa008
Abstract
How should liberal-democratic governments deal with emerging vaccination hesitancy when that leads to the resurgence of diseases that for decades were under control? This article argues that vaccination policies should be justified in terms of a proper weighing of the rights of children to be protected against vaccine-preventable diseases and the rights of parents to raise their children in ways that they see fit. The argument starts from the concept of the ‘best interests of the child involved’. The concept is elaborated for this context into the dual regime structure in which parents have fiduciary authority over what they consider to be best for their child, and the state has fiduciary authority over a child’s basic interests. This argument leads to conditional mandatory vaccination programs that should be informed by a correct balancing of the two legal principles of proportionality and precaution. This results in contextual childhood vaccination policies of upscaling interference: a three-tiered approach of increased intrusion, from voluntary program when possible and mandatory or even compulsory programs when necessary to protect the child’s basic interests.

Global Measles Epidemic Risk: Current Perspectives on the Growing Need for Implementing Digital Communication Strategies

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Risk Management and Healthcare Policy
https://www.dovepress.com/risk-management-and-healthcare-policy-archive56
[Accessed 05 Dec 2020]

 

Review
Global Measles Epidemic Risk: Current Perspectives on the Growing Need for Implementing Digital Communication Strategies
Bozzola E, Spina G, Tozzi AE, Villani A
Published Date: 3 December 2020

A blueprint for translational regenerative medicine

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Science Translational Medicine
02 December 2020 Vol 12, Issue 572
https://stm.sciencemag.org/

 

Review
A blueprint for translational regenerative medicine
By James P. K. Armstrong, Timothy J. Keane, Anne C. Roques, P. Stephen Patrick, Claire M. Mooney, Wei-Li Kuan, Venkat Pisupati, Richard O. C. Oreffo, Daniel J. Stuckey, Fiona M. Watt, Stuart J. Forbes, Roger A. Barker, Molly M. Stevens
Science Translational Medicine02 Dec 2020 Full Access
This Review outlines a practical blueprint for academics seeking to develop translational regenerative therapies.
Abstract
The past few decades have produced a large number of proof-of-concept studies in regenerative medicine. However, the route to clinical adoption is fraught with technical and translational obstacles that frequently consign promising academic solutions to the so-called “valley of death.” Here, we present a proposed blueprint for translational regenerative medicine. We offer principles to help guide the selection of cells and materials, present key in vivo imaging modalities, and argue that the host immune response should be considered throughout design and development. Last, we suggest a pathway to navigate the often complex regulatory and manufacturing landscape of translational regenerative medicine.

Next-generation rotavirus vaccine developers meeting: Summary of a meeting sponsored by PATH and the bill & melinda gates foundation (19–20 June 2019, Geneva)

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Vaccine
Volume 38, Issue 52 Pages 8247-8412 (14 December 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/52

 

Conference info Abstract only
Next-generation rotavirus vaccine developers meeting: Summary of a meeting sponsored by PATH and the bill & melinda gates foundation (19–20 June 2019, Geneva)
Alan Fix, Carl D. Kirkwood, Duncan Steele, Jorge Flores
Pages 8247-8254

Parental preferences for HPV vaccination in junior middle school girls in China: A discrete choice experiment

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Vaccine
Volume 38, Issue 52 Pages 8247-8412 (14 December 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/52

 

Research article Abstract only
Parental preferences for HPV vaccination in junior middle school girls in China: A discrete choice experiment
Shan Zhu, Jie Chang, Khezar Hayat, Pengchao Li, … Yu Fang
Pages 8310-8317

The role of manufacturers in the implementation of global traceability standards in the supply chain to combat vaccine counterfeiting and enhance safety monitoring

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Vaccine
Volume 38, Issue 52 Pages 8247-8412 (14 December 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/52

 

Research article Open access
The role of manufacturers in the implementation of global traceability standards in the supply chain to combat vaccine counterfeiting and enhance safety monitoring
Stephen Jarrett, Taufik Wilmansyah, Yudha Bramanti, Hikmat Alitamsar, … Sonia Pagliusi
Pages 8318-8325

A survey of office practice: Parents, front office staff, nurses and clinicians hold disparate views on adolescent vaccines

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Vaccine
Volume 38, Issue 52 Pages 8247-8412 (14 December 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/52

 

Research article Abstract only
A survey of office practice: Parents, front office staff, nurses and clinicians hold disparate views on adolescent vaccines
James R. Roberts, Erin Dawley, Connor Garbe, Townsend Cooper, … Paul M. Darden
Pages 8326-8333

Understanding the perceptions of Chinese women of the commercially available domestic and imported HPV vaccine: A semantic network analysis

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Vaccine
Volume 38, Issue 52 Pages 8247-8412 (14 December 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/52

 

Research article Abstract only
Understanding the perceptions of Chinese women of the commercially available domestic and imported HPV vaccine: A semantic network analysis
Qi Wang, Wen Zhang, Hongning Cai, Yuan Cao
Pages 8334-8342

Effectiveness of influenza vaccination during pregnancy to prevent severe infection in children under 6 months of age, Spain, 2017–2019

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Vaccine
Volume 38, Issue 52 Pages 8247-8412 (14 December 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/52

 

Research article Abstract only
Effectiveness of influenza vaccination during pregnancy to prevent severe infection in children under 6 months of age, Spain, 2017–2019
Clara Mazagatos, Pere Godoy, Carmen Muñoz Almagro, Francisco Pozo, … Pilar Gallego Berciano

Access and Unmet Needs of Orphan Drugs in 194 Countries and 6 Areas: A Global Policy Review With Content Analysis

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Value in Health
December 2020 Volume 23 Issue 12 p1523-1672
https://www.valueinhealthjournal.com/current

 

HEALTH POLICY ANALYSIS
Access and Unmet Needs of Orphan Drugs in 194 Countries and 6 Areas: A Global Policy Review With Content Analysis
Adrienne Y.L. Chan,et al.,
Published online: October 30, 2020 p1580-1591
Open Access

Preferences for Accessing Electronic Health Records for Research Purposes: Views of Parents Who Have a Child With a Known or Suspected Genetic Condition

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Value in Health
December 2020 Volume 23 Issue 12 p1523-1672
https://www.valueinhealthjournal.com/current

 

PREFERENCE-BASED ASSESSMENTS
Preferences for Accessing Electronic Health Records for Research Purposes: Views of Parents Who Have a Child With a Known or Suspected Genetic Condition
Melissa Raspa, et al.
Published online: October 26, 2020 p1639-1652

Media/Policy Watch

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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 05 Dec 2020
Global
Britain’s Vaccine Nationalism
The country has bet that, outside the EU, it can better regulate its economy to become more competitive.
Tom McTague December 3, 2020

 

BBC
http://www.bbc.co.uk/
Accessed 05 Dec 2020
[No new, unique, relevant content]

 

The Economist
http://www.economist.com/
Accessed 05 Dec 2020
[No new, unique, relevant content]

 

Financial Times
https://www.ft.com/
Accessed 05 Dec 2020
Opinion The FT View
Vaccines and the appliance of science
Inoculating the world would be impossible without the humble fridge
The editorial board

Coronavirus Business Update
UK vaccine approval triggers flurry of responses from other countries
December 2, 2020

 

Forbes
http://www.forbes.com/
Accessed 05 Dec 2020
Coronavirus  |  Dec 4, 2020
UK Vaccine Approval Sets Worrying Precedent For World Leaders
The British government’s decision to forego a more rigorous approval process for Covid-19 vaccines has received criticism from EU regulators—and rightly so.
By William A. Haseltine Contributor

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 05 Dec 2020
Snapshot December 2, 2020
The Dangers of Vaccine Disillusionment
A viable immunization is good news, but it won’t mean the end of masks and social distancing.
Josh Michaud and Jen Kates

 

Foreign Policy
http://foreignpolicy.com/
Accessed 05 Dec 2020
Explainer | December 3, 2020, 10:35 AM
Where Do Things Stand With the COVID Vaccine Rollout?
The U.K.’s quick approval of the Pfizer vaccine means some Britons will get shots starting next week—but in the rest of the world, it’s going to take a while for regular people to get inoculated.
Allison Meakem, Augusta Saraiva

 

The Guardian
http://www.guardiannews.com/
Accessed 05 Dec 2020
NHS staff no longer top priority for vaccine despite fear of third wave
Health officials warn infections at Christmas gatherings could lead to overwhelmed hospitals
Denis Campbell, Nicola Davis and Robert Booth
Thu 3 Dec 2020 19.01 EST
NHS staff will no longer get the coronavirus vaccine first after a drastic rethink about who should be given priority, it emerged last night.
The new immunisation strategy is likely to disappoint and worry thousands of frontline staff – and comes amid urgent warnings from NHS chiefs that hospitals could be “overwhelmed” in January by a third wave of Covid-19 caused by mingling over Christmas…

 

New Yorker
http://www.newyorker.com/
Accessed 05 Dec 2020
The New Yorker Interview
Atul Gawande on Coronavirus Vaccines and Prospects for Ending the Pandemic
The New Yorker staff writer, now a member of President-elect Biden’s COVID-19 advisory board, discusses when a vaccine might be ready for distribution, who should receive it, and whether eradicating the virus is possible.
By David Remnick December 4, 2020

 

New York Times
http://www.nytimes.com/
Accessed 05 Dec 2020
Health
The Elderly vs. Essential Workers: Who Should Get the Coronavirus Vaccine First?
The C.D.C. will soon decide which group to recommend next, and the debate over the trade-offs is growing heated. Ultimately, states will determine whom to include.
By Abby Goodnough and Jan Hoffman
PRINT EDITION Officials Agonize Over Recipients Of First Vaccines | December 6, 2020

Opinion
Why Inmates Should Be at the Front of the Vaccination Lines
The coronavirus spreads in prisons and then finds its way outside to infect others.
By Emily Bazelon Dec. 3

Europe
U.K. and U.S. Officials Spar Over ‘Vaccine Nationalism’
Scientists warned that a debate over which country’s regulatory system is better could undermine public faith in vaccines. Meanwhile, Britons waited to learn how soon they can get coronavirus shots.
By Benjamin Mueller Dec. 3

Technology
Facebook says it will remove coronavirus vaccine misinformation.
The step goes beyond what the social network previously did on vaccine falsehoods by taking down the false claims entirely.
By Mike Isaac Dec. 3

Politics
China Poised to Be First to Distribute Virus Vaccine in Latin America, U.S. Official Says
China, which has been expanding its presence in the region, is likely to beat the United States in its own backyard with vaccine diplomacy as Washington looks “at taking care of the U.S. first.”
By Carol Rosenberg Dec. 2

Health
Many Trial Volunteers Got Placebo Vaccines. Do They Now Deserve the Real Ones?
Some vaccine experts worry that “unblinding” the trials and giving all of the volunteers vaccines would tarnish the long-term results.
By Carl Zimmer and Noah Weiland Dec. 2

 

Washington Post
https://www.washingtonpost.com/
Business
Trump’s Operation Warp Speed promised a flood of covid vaccines. Instead, states are expecting a trickle.
The administration pledged several hundred million doses in 2020. Companies will actually ship about 10 percent of that.
Christopher Rowland, Lena H. Sun, Isaac Stanley-Becker and Carolyn Y. Johnson · Business · Dec 5, 2020
[See COVID above for detail]

Think Tanks et al

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Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 05 Dec 2020
[No new relevant content]
 
 
Center for Global Development [to 05 Dec 2020]
http://www.cgdev.org/page/press-center
[No new relevant content]

 
 
Chatham House [to 05 Dec 2020]
https://www.chathamhouse.org/
Accessed 05 Dec 2020
[No new relevant content]

 
 

CSIS
https://www.csis.org/
Accessed 05 Dec 2020
Upcoming Event
Online Event: Year-End Reflections on 2020 with Dr. Anthony Fauci
December 14, 2020
 
 

Council on Foreign Relations
http://www.cfr.org/
Accessed 05 Dec 2020
[No new relevant content]

 
 

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 05 Dec 2020
[No new relevant content]

Vaccines and Global Health: The Week in Review :: 28 November 2020

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Vaccines and Global Health: The Week in Review is a weekly digest  summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date

.– Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

– pdf version:  A pdf of the current issue is available here: 

vaccines-and-global-health_the-week-in-review_28-nov-2020Download

– 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

Gavi and IOM join forces to improve immunisation coverage for migrants

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Milestones :: Perspectives :: Research

Gavi [to 28 Nov 2020]
https://www.gavi.org/
News releases
24 November 2020
Gavi and IOM join forces to improve immunisation coverage for migrants
:: Memorandum of understanding signed today will strengthen collaboration on vaccination efforts and related health services for migrants and forcibly displaced persons across the world
:: The agreement focuses on reaching missed communities in humanitarian and emergency settings with vaccination
:: Dr Seth Berkley: Reaching migrant, refugee and displaced populations “becomes all the more important as we plan to rollout COVID-19 vaccines worldwide.”
:: António Vitorino: Vaccines are key to keep people on the move and the communities they live in as safe as possible.

Geneva, 24 November 2020 – Today, Gavi the Vaccine Alliance and the International Organization for Migration (IOM) signed a memorandum of understanding to strengthen their collaboration on vaccination efforts and related health services for migrants and forcibly displaced persons across the world, both regarding routine immunisations as well as in response to outbreaks. This milestone will be particularly critical in ensuring that migrants and other people on the move are considered and included, as the world continues its efforts to find a safe COVID-19 vaccine and is developing mechanisms, such as the COVAX Facility, to ensure a fair distribution so that as many lives as possible can be saved.

“Despite enormous progress over the past two decades ensuring children everywhere have access to lifesaving vaccines, 14 million children every year still miss out on basic vaccines,” said Gavi CEO Dr Seth Berkley. “We know a disproportionate amount of these unprotected children come from migrant, refugee and displaced populations, who are too often overlooked when it comes to basic health care. This obviously becomes all the more important as we plan to rollout COVID-19 vaccines worldwide; we cannot allow these populations to miss out on what could be one of our best routes out of this pandemic. That’s why we’re delighted to partner with IOM, to help provide a healthier future to some of the most vulnerable people on earth.”

“Vaccines are one of the most powerful tools we have to keep people on the move, the communities they leave behind and the communities they join as safe and healthy as possible,” stressed IOM Director General António Vitorino. “This reinforced partnership will be critical in helping IOM achieve just that and contribute tangibly to the realization of true universal health coverage.”

The agreement signed by the two organizations focuses on reaching missed communities in humanitarian and emergency settings with vaccination and support routine immunisation through engagement in primary health care systems. The partnership also aims to boost advocacy for the prioritization of vulnerable populations, support operational and policy assistance and facilitate technical collaboration. Specifically, the memorandum of understanding seeks to facilitate collaboration on ensuring the inclusion of migrants, IDPs and refugees in governments’ COVID-19 responses, in particular vaccination efforts…

COVID-19 Vaccines – Trials/Development

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Milestones :: Perspectives :: Research

 

COVID-19 Vaccines – Trials/Development

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
Statement on continuation of vaccine trials
We, (ICMRA members, a global coalition of medicine regulators) have an important role in supporting the worldwide effort to ensure the quality, safety and efficacy of licensed vaccines and to make them available to the public. We have stepped up our global collaboration to facilitate and expedite the development and evaluation of vaccines against SARS-CoV2 (causing COVID-19 disease).

This statement in support of continuing COVID-19 vaccine trials to collect critical data to support regulatory actions and deployment, for as long as is feasible, is intended for all stakeholders, vaccinees, researchers and investigators, academia, regulators and the pharmaceutical industry.

The pandemic represents a major global unsolved public health and economic crisis, which is still far from being under control as we see peaks of transmission, morbidity and mortality over time in different locations. The availability of safe and effective vaccines is anticipated to be an important component of the overall response to the emergency and to contribute to a return to normality.

Regulators have set up flexible and agile procedures to facilitate the swift analysis of clinical trial results submitted to them. These analyses will support clear, independent and transparent benefit-risk evaluations, leading to decisions on the approval of, or early access to, safe and effective vaccines against COVID-19.

To determine that the benefit of a vaccine outweighs its potential risk, regulators need robust and convincing evidence of the safety and efficacy that is obtained from well-designed randomised and controlled trials. Initial positive evidence of the vaccine’s safety and efficacy used to support a regulatory action may be based on planned interim or final analyses that occur when a pre-defined number of cases of COVID-19 disease have occurred in a clinical trial. In these situations, it will be of the utmost importance to continue gathering data about the vaccine safety and efficacy in the longer-term after the interim or final analysis is completed.

 

Specifically, continued follow-up of clinical trial participants after a regulatory decision has been made can provide important additional and more precise information on longer-term safety and efficacy against specific aspects of SARS-CoV-2 disease or infection, including efficacy against severe disease, efficacy in important subgroups, potential risks of vaccine-induced enhanced disease and whether protection against COVID-19 disease wanes over time.

Thus, continued evaluation of the vaccinated and the unvaccinated (control subjects who do not receive a vaccine against COVID-19) groups in clinical trials for as long as feasible will provide invaluable information.  

For these reasons, investigators and sponsors should develop strategies to ensure continuation of follow-up of vaccinated and control groups for as long as possible after any regulatory approval that is based on planned analyses conducted while trials are still ongoing and after final analyses are completed.

Therefore, unless maintaining participants in their randomised treatment groups (vaccinated or control) after a vaccine is approved is clearly infeasible, we recommend that clinical trials should proceed as initially planned with a follow-up of at least one year or more from completion of assigned doses. In making this recommendation, we recognise that the feasibility of maintaining the group assignment for at least one year will depend on factors such as the population enrolled into a trial (e.g. in terms of whether they are young and healthy or have reasons to be predisposed to develop severe COVID-19), informed decisions made by clinical trial participants, the availability of COVID-19 vaccine(s), and the characteristics of SARS-CoV-2 epidemics. It will be necessary for sponsors, investigators, public health authorities and regulators to assess each situation that may arise.

COVID-19 Vaccines Regulatory Processes :: Announcements/Meeting Dates/Milestones

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Milestones :: Perspectives :: Research

 

COVID-19 Vaccines Regulatory Processes :: Announcements/Meeting Dates/Milestones

 

Week of 23 November 2020
CHINA – Leading vaccine maker seeks market approval
2020-11-26
Leading COVID-19 vaccine developer Sinopharm has submitted a market approval application to China’s top market regulator, Xinhua News Agency quoted the company’s Deputy General Manager Shi Shengyi as saying on Nov 25.
The Chinese company has two experimental COVID-19 vaccines – both of which are the inactivated type – undergoing Phase 3 clinical trials overseas.
The Xinhua report did not reveal details about the application.

 

::::::

Week of 30 November 2020
U.K. – UK set to approve Pfizer-BioNTech Covid vaccine within days
Rollout of two-shot jab could begin as soon as December 7
28 November 2020 Sebastian Payne and Donato Paolo Mancini
The UK is poised to become the first western country to approve a Covid-19 vaccine, with the independent regulator set to grant approval within days. Deliveries of the vaccine developed by BioNTech and Pfizer would begin within hours of the authorisation, according to government officials. The first injections could take place from December 7. The UK has ordered 40m doses of the two-shot product, which preliminary data found to be more than 95 per cent effective in preventing disease. Vaccines would normally be authorised by the European Medicines Agency until the end of the Brexit transition on December 31. However the UK’s Medicines and Healthcare Products Regulatory Agency has the power to temporarily authorise products, in cases of urgent public need…

UK MHRA Medicines and Healthcare products Regulatory Agency
:: Pfizer/BioNTech COVID-19 vaccine: MHRA statement 23 November 2020
…Approval process for a potential COVID-19 vaccine
:: Until the end of December, and as part of the transition period, COVID-19 vaccine candidates can be licensed (authorised) via the European Medicines Agency (EMA) and that authorisation will automatically be valid in the UK.
:: However, if a suitable COVID-19 vaccine candidate, with strong supporting evidence of safety, quality and effectiveness from clinical trials becomes available before the end of the transition period, EU legislation allows for temporary authorisation of supply in the UK, based on the public health need.
:: The MHRA will evaluate the data rigorously for quality, safety and effectiveness to reach an independent, scientifically robust opinion. The data must include results from lab and clinical trials in humans; manufacturing and quality controls, product sampling, and testing of the final product.
:: Any COVID-19 vaccine candidate submitted after the transition period ends in January 2021 will not need to go through a European marketing authorisation for use in Great Britain and will instead be assessed directly by the MHRA. The MHRA is globally recognised for requiring the highest standards of safety, quality and effectiveness for any vaccine.

 

::::::

1 December 2020 – Tuesday – 1400-1700/New York
Advisory Committee on Immunization Practices (ACIP)
Webcast: December 1, 2020 meeting is a virtual meeting. No registration is required.
Meeting time, 1400 – 1700 EDT (times subject to change).
Webcast Link
Meeting Agenda
Selected Agenda Elements
:: Allocation of initial supplies of COVID-19 vaccine: Phase 1a Dr. Kathleen Dooling (CDC/NCIRD)
:: Clinical considerations for populations included in Phase 1a Dr. Sara Oliver (CDC/NCIRD)
:: Post-authorization safety monitoring update Dr. Tom Shimabukuro (CDC/NCEZID)
:: Public Comment
VOTE
:: Allocation of initial supplies of COVID-19 vaccine: Phase 1a Dr. Kathleen Dooling (CDC/NCIRD)

 

::::::

4 December 2020 – Friday – 1300-1700/New York
U.S. – National Vaccine Advisory Committee NVAC Meeting (Virtual)
Selected Agenda Elements
OPENING REMARKS
Admiral Brett Giroir, Assistant Secretary for Health
APPROACHES TO INCLUDE PREGNANT WOMEN IN COVID-19 CLINICAL TRIALS
Dr. Sascha Ellington, Centers for Disease Control and Prevention
Dr. Ruth Faden, Johns Hopkins University
Dr. Jeff Roberts, Food and Drug Administration
Dr. Linda Eckert, American College of Obstetricians and Gynecologists
Dr. Titi Oduyebo, Centers for Disease Control and Prevention
VACCINE SAFETY SYSTEMS AND COVID-19
Dr. Peter Marks, Food and Drug Administration
Dr. Arnold Monto, Vaccines and Related Biological Products Advisory Committee
Dr. Tom Shimabukuro, Centers for Disease Control and Prevention
Dr. Sonali Kochhar, University of Washington
REGISTER: https://www.hhs.gov/webforms/nvac/index.html

 

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10 December 2020 – Thursday – 0900-1800/New York
FDA – Vaccines and Related Biological Products Advisory Committee
The FDA’s Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.
Webcast Information
CBER plans to provide a free of charge, live webcast of the Vaccines and Related Biological Products Advisory Committee meeting. If there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. The online web conference meeting will be available at the following:
https://youtu.be/owveMJBTc2IExternal Link Disclaimer
https://twitter.com/US_FDAExternal Link Disclaimer (Supported in Chrome browser)
https://fda.yorkcast.com/webcast/Play/d75d80a3eb6e419986181c1a881fe2671d.

 

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11 December 2020 – Thursday – 1300-1630/CET
EMA Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU
:: Agenda – EMA public stakeholder meeting on COVID-19 (PDF/310.91 KB) (new)
:: Documents
:: Live broadcast
EMA is organising this virtual meeting to explain the processes for the development, evaluation, approval and safety monitoring of COVID-19 vaccines in the EU, including EMA’s specific role, to all interested parties.
It will also give the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns, that will be considered by EMA and the European medicines regulatory network in the decision-making process.
Please note that some issues of high public interest, such as patient access to COVID-19 vaccines and national vaccination campaigns, lie outside EMA’s remit and will not be covered at this event.

EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.
Last updated: 16/11/2020
MA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. (a subsidiary of Moderna, Inc.)…The rolling review will continue until enough evidence is available to support a formal marketing authorisation application…

Sputnik V – “the first registered COVID-19 vaccine” [to 28 Nov 2020]

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Milestones :: Perspectives :: Research

 

Editor’s Note:
To better present a global view of COVID-19 vaccine development, regulatory review, procurement and deployment, we will present headlines from this site – which provides as its contact point the Russian Direct Investment Fund [RDIF].

Sputnik V – “the first registered COVID-19 vaccine” [to 28 Nov 2020]
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
RDIF and Hetero agree to produce over 100 million doses of the Sputnik V vaccine in India
Press release, 27.11.2020

The cost of one dose of the Sputnik V vaccine will be less than $10 for international markets
Press release, 24.11.2020

Second interim analysis of clinical trial data showed a 91.4% efficacy for the Sputnik V vaccine on day 28 after the first dose; vaccine efficacy is over 95% 42 days after the first dose
Press release, 24.11.2020

COVID-19 Vaccines :: Procurement/Distribution/Logistics

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Milestones :: Perspectives :: Research

COVID-19 Vaccines :: Procurement/Distribution/Logistics

Moderna Announces the European Commission’s Approval of Advance Purchase Agreement for Initial 80 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
Option granted to European Commission to purchase up to an additional 80 million doses
Agreement reflects Moderna’s commitment to make its vaccine available in multiple countries

November 25, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the European Commission has approved an agreement to secure 80 million doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19, as part of the European Commission’s goal to secure access to a safe and effective COVID-19 vaccine for Europe.
Under the terms of the proposed agreement, the European Commission has the option to increase their purchase of mRNA-1273, from 80 million doses to a total of up to 160 million doses. The agreement will be finalized following a brief review period by the European Union Member States. This announcement follows the conclusion of advanced exploratory talks with the European Commission that began on August 24, 2020. Delivery of the vaccine could begin as early as the first quarter 2021 if it is approved for use by the European Medicines Agency (EMA) human medicines committee (CHMP), which started a rolling review of mRNA-1273 on November 17…

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COVAXX Announces $2.8 Billion in Advance Purchase Commitments to Deliver More Than 140 Million Vaccine Doses to Emerging Countries
:: COVAXX’s UB-612 is the only multitope, synthetic peptide-based vaccine candidate in the clinic
:: Company’s manufacturing facilities in place to produce 100 million doses in 1H 2021 and up to 1 billion by YE 2021
:: UB-612 distribution utilizes normal refrigeration (no freezing required)
:: Company partnered with Maersk for worldwide shipping and logistics
:: Phase 2/3 clinical trials to begin end of 2020/1Q 2021 in Asia, Latin America, and U.S.

November 25, 2020
HAUPPAUGE, N.Y.–(BUSINESS WIRE)–COVAXX, a U.S. company developing a multitope peptide-based vaccine to fight COVID-19, announces advanced purchase commitments of more than 140 million doses of its UB-612 vaccine, totaling over $2.8 billion, to deliver vaccines in multiple countries, including Brazil, Ecuador and Peru. These public and private commitments follow the start of human trials in Taiwan and the September agreement with Diagnosticos da America SA (Dasa S.A.), the largest clinical diagnostic company in Brazil, to conduct Phase 2/3 clinical trials and distribute vaccines within Brazil.

“In parallel with the expedited clinical development of UB-612, we are working to help countries with the greatest unmet needs customize their plans for vaccine studies, supply and distribution,” said Mei Mei Hu, co-founder and CEO of COVAXX. “The realistic view of vaccine production is that we will need a wide range of vaccine options utilizing different technologies to meet worldwide demand. As much as vaccines matter, vaccinations matter more. To be administered effectively, vaccines need to demonstrate easy and affordable distribution, durability of response with the capability to further extend it with effective boosts, as well as the ability to adapt to a potential mutation in the virus while building on the first vaccines made available.”

COVAXX (not to be confused with single “x” COVAX) is currently completing Phase 1 clinical trials of UB-612 in Taiwan and has an agreement with the University of Nebraska Medical Center (UNMC), home of the National Pandemic Center, to also conduct trials in the U.S. Last month, COVAXX announced a global logistics partnership with Maersk, the world’s largest shipping and integrated logistics provider, that creates a framework for all transportation and supply chain services that will be needed to deliver COVAXX’s UB-612 around the world…

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COVAX Update: UNICEF working with global airlines and freight providers to plan delivery of COVID-19 vaccines
UNICEF kickstarts discussions with over 350 logistics organizations to step up delivery plans for eventual COVID-19 vaccines

NEW YORK, 23 November 2020: UNICEF is working with major global airlines and freight providers to step up efforts to deliver COVID-19 vaccines to over 92 countries around the world as soon as vaccines become available.

To kickstart preparations, UNICEF together with the Pan American Health Organization (PAHO) and the International Air Transport Association (IATA), briefed major global airlines last week on the expected capacity requirements and discussed ways to transport close to 2 billion doses of COVID-19 vaccines in 2021. This is in addition to the 1 billion syringes that need to be transported by sea-freight. 

This virtual meeting comes close on the heels of the first-ever logistics event held virtually by UNICEF to discuss the transportation of COVID-19 vaccines. The landmark discussion brought together more than 350 logistics partners, including air freight operators, shipping lines and global logistics associations.

“As work continues to develop COVID-19 vaccines, UNICEF is stepping-up efforts with airlines, freight operators, shipping lines and other logistics associations to deliver life-saving vaccines as quickly and safely as possible,” said Etleva Kadilli, Director of UNICEF’s Supply Division. “This invaluable collaboration will go a long way to ensure that enough transport capacity is in place for this historic and mammoth operation. We need all hands on deck as we get ready to deliver COVID-19 vaccine doses, syringes and more personal protective equipment to protect front line workers around the globe. By protecting these workers, we are ultimately protecting the millions of children who depend on their critical services.”

In the coming weeks, UNICEF is also assessing existing transport capacity to identify gaps and future requirements. The procurement, delivery and distribution of COVID-19 vaccines is anticipated to be the largest and fastest such operation ever undertaken. UNICEF is leading efforts to procure and deliver vaccines from manufacturers that have agreements with the COVAX Facility.  In collaboration with PAHO, UNICEF will coordinate the purchase and delivery for 92 low- and lower middle-income economies as quickly and securely as possible.

These efforts build on UNICEF’s longstanding efforts with the logistics industry to transport supplies around the world despite restrictions related to the pandemic. Since January, UNICEF has delivered more than US$190 million worth of COVID-19 supplies such as masks, gowns, oxygen concentrators and diagnostic test kits in support of countries as they respond to the pandemic.

As the largest single vaccine buyer in the world, UNICEF normally procures more than 2 billion doses of vaccines annually for routine immunization and outbreak response on behalf of nearly 100 countries. This unparalleled expertise includes the coordination of thousands of shipments with various cold chain requirements, making UNICEF an expert in supply chain management of temperature-controlled products, which is especially needed during this historic undertaking. To minimise disruptions to routine immunization programmes due to the operations related to the COVID-19 vaccines and syringes, UNICEF and partners will continue to coordinate closely with logistics operators for timely delivery around the world.

“The support of governments, partners and the private sector will be paramount to transport vaccines for deadly diseases such as measles, diphtheria and tetanus, as well as for COVID-19, as efficiently as possible,” Kadilli said.

Last month, UNICEF began a process to stockpile more than 1 billion syringes by 2021 to guarantee initial supply and pre-position in advance of COVID-19 vaccines.

Ad Council Launches $50 Million Fund for National COVID-19 Vaccine Education Effort

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Milestones :: Perspectives :: Research

 

Ad Council Launches $50 Million Fund for National COVID-19 Vaccine Education Effort
With many Americans not yet committed to getting a COVID-19 vaccine when available, leaders in communications, policy and health unite to create a research-driven public education campaign
NEW YORK, Nov. 23, 2020 /PRNewswire/ — The Ad Council today announced plans for a communications effort to encourage vaccination against the virus, which will represent one of the largest public education campaigns in history. This effort will be launched in partnership with the COVID Collaborative, a national assembly that has brought together leading experts and institutions across health, education and the economy to turn the tide on the pandemic by supporting state and local officials.
This national initiative will complement government efforts and has set an initial goal of raising $50 million from the private sector, including the philanthropic community and corporations. This effort will be guided by science and health experts from the COVID Collaborative, amplified by partnerships across every sector and rooted in extensive research with key audiences…

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

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EMERGENCIES

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

Weekly Epidemiological and Operational updates
last update: 14 November 2020, 10:30 GMT-4
Confirmed cases :: 61 299 371 [week ago: 57 274 018] [two weeks ago: 53 164 803]
Confirmed deaths :: 1 439 784 [week ago: 1 368 000] [two weeks ago: 1 300 576]
Countries, areas or territories with cases :: 220

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Weekly epidemiological update – 24 November 2020
Overview
This past week, the global acceleration in case incidence has slowed down, with around 4 million new cases reported; however, death rates continue to increase with over 67 000 new deaths reported.

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POLIO Public Health Emergency of International Concern (PHEIC); WHO/OCHA Emergencies

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Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 25 November 2020
:: Fahima Ahmed Hassan is a 25-year-old community mobilizer who goes the extra mile to ensure parents of children under the age of five are informed of Somalia’s polio vaccination campaigns and are ready for their children to be vaccinated. Read about Fahima and other Community mobilizers who build trust with communities ahead of crucial vaccination campaigns.
:: The GPEI has published an Interim guidance document on the use of Novel Oral Polio Vaccine type 2 (nOPV2) which is meant to provide context and policy guidance on the use of nOPV2 in response to Type 2 circulating Vaccine-Derived Poliovirus (cVDPV2) during the Initial Use Period. This document is an addendum to the “Standard Operating Procedures: Responding to a poliovirus event or outbreak”, Version 3.1’ (SOPs) (5).

Summary of new WPV and cVDPV viruses this week (AFP cases and ES postitives):
:: Afghanistan: two WPV1 cases, 24 cVDPV2 cases and 18 cVDPV2 positive environmental samples
:: Pakistan: two WPV1 positive environmental samples and 21 cVDPV2 cases
:: Burkina Faso: four cVDPV2 cases
:: Côte d’Ivoire: 16 cVDPV2 cases and 4 cVDPV2 positive environmental samples
:: Niger: two cVDPV2 cases
:: South Sudan: seven cVDPV2 cases and 2 cVDPV2 positive environmental samples
:: Sudan: two cVDPV2 cases
:: Somalia: one cVDPV2 case and one cVDPV2 positive environmental sample
:: Yemen: two cVDPV1 cases

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::::::

Editor’s Note:
A number of country pages below did not load at inquiry.

WHO Grade 3 Emergencies [to 28 Nov 2020]

Democratic Republic of the Congo – No new digest announcements identified
Mozambique floods – No new digest announcements identified
Nigeria – No new digest announcements identified
Somalia – No new digest announcements identified
South Sudan – No new digest announcements identified
Syrian Arab Republic – No new digest announcements identified
Yemen – No new digest announcements identified

::::::

WHO Grade 2 Emergencies [to 28 Nov 2020]
Iraq
:: Restoration works completed at East Erbil Emergency Hospital and specialized services resumed for patients 24 November 2020

Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burkina Faso – No new digest announcements identified
Burundi – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Ethiopia – No new digest announcements identified
Iran floods 2019 – No new digest announcements identified
Libya – No new digest announcements identified
Malawi Floods – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Mozambique – No new digest announcements identified
Myanmar – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

::::::

WHO Grade 1 Emergencies [to 28 Nov 2020]

Djibouti
:: Djibouti se prépare aux Journées nationales de vaccination contre la poliomyélite
25 novembre 2020 – Près de 130 000 enfants de Djibouti vont être vaccinés contre le poliovirus dans le cadre d’une campagne de vaccination nationale contre la poliomyélite qui devrait débuter lundi 23 novembre et s’étendra sur quatre jours

Chad – 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

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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 – No new digest announcements identified
Yemen – No new digest announcements identified

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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.
East Africa Locust Infestation
:: Desert Locust situation update – 24 November 2020

COVID-19
:: Coronavirus Disease (COVID-19): Weekly Epidemiological Update (24 November 2020)

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WHO & Regional Offices [to 28 Nov 2020]

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WHO & Regional Offices [to 28 Nov 2020]

 

Webinar: a multilateral response to misinformation and data transparency
30 November 2020 15:00 – 17:00 CET

26 November 2020 Departmental news
WHO releases new guidance on integrating mental health in radiological and nuclear emergency response

25 November 2020 News release
Every move counts towards better health – says WHO

25 November 2020 Departmental news
Update: WHO revision of pain management guidelines

23 November 2020 Departmental news
Countdown to 2030 launches expanded 2020 country profiles on early childhood development

23 November 2020 Departmental news
The city of lights glows teal for cervical cancer elimination

 

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Weekly Epidemiological Record 27 November 2020, Vol. 95, No. 48, pp. 585–608
:: Meeting of the Strategic Advisory Group of Experts on Immunization, October 2020 –
conclusions and recommendations

::::::

 

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

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
:: Act now to address the shadow pandemic of violence against women
25 November 2020 Statement SEARO
By Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia
Urgent action is needed across the WHO South-East Asia Region to strengthen efforts to protect women and girls from violence and to support their health needs amid the ongoing COVID-19 pandemic…

WHO European Region EURO
:: WHO and ECDC call for improved HIV testing in Europe 26-11-2020
:: WHO’s Emergency Medical Teams inspire countries and colleagues during the COVID-19 pandemic 25-11-2020
:: COVID-19 update: doing our share, a new horizon with technological and pharmaceutical development, and preserving the rights of children (delivered in Russian) 24-11-2020
:: Health workers at risk, older adults and residents of long-term care facilities to be prioritized for COVID-19 vaccination 23-11-2020

WHO Eastern Mediterranean Region EMRO
:: WHO supports civil/military cooperation on COVID-19 database
26 November 2020 – A collaborative initiative between the Lebanese army and the Ministry of Public Health, supported by WHO, has created a comprehensive database for COVID-19 cases in Lebanon.
Dr Iman Shankiti, WHO Representative in Lebanon, accompanied by a WHO team, visited the army hospital in Badaro, Beirut, to review equipment installed by WHO for the project.
This initiative falls under a project to create civil/military cooperation during the pandemic through the exchange of information between the Ministry of Public Health and the Lebanese army on cases and other areas related to the coronavirus. This approach has been pioneered by Lebanon, with WHO providing equipment and training for the army with the support of the Ministry.

WHO Western Pacific Region
No new digest content identified

CDC/ACIP [to 28 Nov 2020]

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CDC/ACIP [to 28 Nov 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
COVID-19 Travel Health Notice Levels and Testing for International Travelers
Sunday, November 22, 2020
…CDC’s Travel Health Notices inform travelers and clinicians about current health issues in destinations around the world. For most diseases, the Travel Health Notices have 3 levels. This new 4-level travel health notice system is specific to COVID-19 and details the level of COVID-19 in international destinations and U.S. territories.

Advisory Committee on Immunization Practices (ACIP)
Webcast: December 1, 2020 meeting is a virtual meeting. No registration is required.
Meeting time, 1400 – 1700 EDT (times subject to change).
Webcast Link
Meeting Agenda

Coronavirus Disease 2019 (COVID-19)
Selected Resources
:: The Advisory Committee on Immunization Practices’ Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine – United States, 2020 Wednesday, November 25, 2020
:: How CDC Is Making COVID-19 Vaccine Recommendations Wednesday, November 25, 2020
:: Frequently Asked Questions about COVID-19 Vaccination Tuesday, November 24, 2020

MMWR News Synopsis Friday, November 27, 2020
:: Decline in SARS-CoV-2 Antibodies After Mild Infection Among Frontline Health Care Personnel in a Multistate Hospital Network — 12 States, April–August 2020
:: Implementation of Hospital Practices Supportive of Breastfeeding in the Context of COVID-19 — United States, July 15–August 20, 2020
:: COVID-19 Outbreak Associated with a 10-Day Motorcycle Rally in a Neighboring State — Minnesota, August–September 2020 (Early release November 20, 2020)
:: Trends in County-Level COVID-19 Incidence in Counties With and Without a Mask Mandate — Kansas, June 1–August 23, 2020 (Early release November 20, 2020)
:: The Advisory Committee on Immunization Practices’ Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine — United States, 2020 (Early release November 23, 2020)

#AfricaMaskWeek launches to build continent-wide movement for mask-wearing

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Africa CDC [to 28 Nov 2020]
http://www.africacdc.org/
News
#AfricaMaskWeek launches to build continent-wide movement for mask-wearing
ADDIS ABABA, ETHIOPIA, 23 NOVEMBER 2020. #AfricaMaskWeek launches today across the continent, from 23 to 30 November 2020. Led by the Pandemic Action Network, in partnership with the Africa Centres for Disease Control and Prevention (Africa CDC), the African Union Office of the Youth Envoy, the African Youth Front on Coronavirus, Resolve to Save Lives, and many other organizations, this week-long social media campaign will encourage mask-wearing across the African continent…

China CDC

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

National Health Commission of the People’s Republic of China [to 28 Nov 2020]
http://en.nhc.gov.cn/
News
Nov 28: Daily briefing on novel coronavirus cases in China
On Nov 27, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 6 new cases of confirmed infections.

Leading vaccine maker seeks market approval
2020-11-26
Leading COVID-19 vaccine developer Sinopharm has submitted a market approval application to China’s top market regulator, Xinhua News Agency quoted the company’s Deputy General Manager Shi Shengyi as saying on Nov 25.
The Chinese company has two experimental COVID-19 vaccines – both of which are the inactivated type – undergoing Phase 3 clinical trials overseas.
The Xinhua report did not reveal details about the application.
Liu Jingzhen, chairman of Sinopharm, said previously that hundreds of thousands of people in China have been injected with either one of the vaccines through emergency authorization, and 56,000 of them have traveled abroad after inoculation.
No severe adverse effects have been observed among them, and none of those now living overseas has been infected with the virus, he said.
Regarding the overseas trials, Liu said nearly 60,000 volunteers from 10 countries have been enrolled in the program, and preliminary results are satisfactory.
The company’s production capability is expected to exceed 1 billion doses by the end of next year.
China now has five COVID-19 vaccines in Phase 3 clinical trials in foreign countries, making it a front-runner in the global race to create a safe, effective vaccine.

National Medical Products Administration [to 28 Nov 2020]
http://english.nmpa.gov.cn/news.html
News
Leading vaccine maker seeks market approval
2020-11-26
[See above]

Announcements

Posted on by

Announcements

 

Paul G. Allen Frontiers Group [to 28 Nov 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 28 Nov 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

 

BMGF – Gates Foundation [to 28 Nov 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 28 Nov 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

 

CARB-X [to 28 Nov 2020]
https://carb-x.org/
News
No new digest content identified.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 28 Nov 2020]
http://cepi.net/
Latest News
The Republic of Korea provides US $9 million contribution to CEPI to advance vaccine development and prepare for future outbreaks
The financial contribution was announced at a virtual signing ceremony attended by Ambassador Nam, Head of the Embassy of the Republic of Korea to Norway, and CEPI CEO, Dr. Richard Hatchett.
COVID-19 25 Nov 2020

Ensuring safety of COVID-19 vaccines
Dr Robert Chen, leading vaccine-safety expert, discusses the importance of safety monitoring for COVID-19 vaccines
COVAX 24 Nov 2020

Indonesia donates US $1 million to further CEPI’s vaccine research and combat epidemic threats
The financial contribution will further vaccine programmes against CEPI’s target diseases.
COVAX 24 Nov 2020

CEPI welcomes University of Oxford / AstraZeneca encouraging interim COVID-19 vaccine efficacy data
“It is terrific to see another approach to vaccine development also yielding such positive findings on an interim analysis,” says CEPI CEO, Richard Hatchett.
23 Nov 2020

 

EDCTP [to 28 Nov 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
24 November 2020
Largest clinical trial in Africa to treat mild to moderate COVID-19 patients launched in 13 countries
Thirteen African countries and an international network of research institutions have joined forces to launch the largest clinical trial in mild-to-moderate COVID-19 outpatients in Africa. The ANTICOV clinical trial aims to identify treatments for these cases and thus to contribute to the prevention of spikes in hospitalisation that could overwhelm health systems in Africa.*

The trial will be conducted by the ANTICOV consortium. It includes 26 prominent African and global R&D organisations. It is coordinated by the Drugs for Neglected Diseases initiative (DNDi).

Funding
Major funding for the ANTICOV consortium is provided by the German Federal Ministry of Education and Research (BMBF) and by the global health agency Unitaid. Early support to launch the initiative was provided by EDCTP under its Covid-19 Emergency call with additional funding from the Swedish government, and the Starr International Foundation, Switzerland. This funding contributed to finalising the study protocol and facilitating expedited reviews by in-country regulatory and ethics authorities. It also supported the timely preparation of trial sites in selected African countries and a robust, standardised data management system.

Study approach
ANTICOV clinical trials will be carried out at 19 sites in Burkina Faso, Cameroon, Côte d’Ivoire, the Democratic Republic of Congo (DRC), Equatorial Guinea, Ethiopia, Ghana, Guinea, Kenya, Mali, Mozambique, Sudan, and Uganda. The study is an open-label, randomised, comparative, ‘adaptive platform trial’ that will test the safety and efficacy of treatments in 2,000 to 3,000 mild-to-moderate COVID-19 patients. The adaptive platform trial is an innovative type of clinical trial pioneered for cancer drugs. It allows for several treatments to be tested simultaneously. Adaptive platform trials enable rapid decisions based on the ongoing analysis of results.

The study will begin testing, against a control arm, the HIV antiretroviral combination lopinavir/ritonavir and the malaria drug hydroxychloroquine, which remains the standard of care for COVID-19 today in numerous African countries.

All clinical trial data generated by ANTICOV will be integrated and shared openly and transparently to inform public health policy. Every effort will be made to work with all relevant partners to ensure that treatments that prove safe and effective will be affordable, available, and accessible for all…

 

Emory Vaccine Center [to 28 Nov 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 28 Nov 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up
Last updated: 27/11/2020

News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 November 2020
PRAC, Last updated: 27/11/2020

News: Call for expressions of interest for Committee for Orphan Medicinal Products (COMP) members positions representing patient organisations
COMP, Last updated: 24/11/2020

News: Workshop on regulatory support for development of orphan medicines
COMP, Last updated: 23/11/2020
On Monday, 30 November, EMA is hosting a workshop to discuss the benefits and impact of early regulatory interactions and incentives for the development of medicines for rare diseases.

 

European Vaccine Initiative [to 28 Nov 2020]
http://www.euvaccine.eu/
Latest News
Nov 16, 2020
RICH Symposium on “Research Infrastructures as Engines for Maximising Impact of Horizon Europe
The RICH Symposium on “Research Infrastructures as Engines for Maximising Impact of Horizon Europe” brought together around 180 participants in the session dedicated to Health & Food. Speakers -including representatives from the European Commission and different Research Infrastructures initiatives- shared their views and expectations regarding how Research Infrastructures could become key components of the Horizon Europe Missions and other parts of the upcoming framework programme…

 

FDA [to 28 Nov 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
November 25, 2020 – Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators

November 24, 2020 – Coronavirus (COVID-19) Update: November 24, 2020
…Also today, the FDA posted two templates with recommendations on what to include in EUA requests for serology tests. These templates provide the FDA’s current recommendations on what data and information should be submitted to the FDA in support of an EUA request or Pre-EUA submission for a SARS-CoV-2 antibody test or home specimen collection devices using dried blood spot. The ..FDA, but alternative approaches can be used…

November 23, 2020 – Coronavirus (COVID-19) Update: November 23, 2020
…The FDA also recently posted a new infographic, The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization, to explain a potential pathway for vaccines.

November 23, 2020 – FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention
…“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Americans will have to be more vigilant than ever as these viruses spread concurrently.”…

November 21, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions.
…“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” said FDA Commissioner Stephen M. Hahn, M.D. “As part of our Coronavirus Treatment Acceleration Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while continuing to study the safety and effectiveness of these treatments.”
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Casirivimab and imdevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.
“The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research. “We will continue to facilitate the development, evaluation and availability of COVID-19 therapies.”…

 

FDA – COVID-19 Vaccines [to 28 Nov 2020]
www.fda.gov/covid19vaccines
Upcoming Events
Vaccines and Related Biological Products Advisory Committee
12/10/2020
The FDA’s Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.

 

Fondation Merieux [to 28 Nov 2020]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation co-organized event
7th Meeting of the GTFCC Working Group on Oral Cholera Vaccine Webinars
November 19 – December 10, 2020 – Webinars

 

Gavi [to 28 Nov 2020]
https://www.gavi.org/
News releases
24 November 2020
Gavi and IOM join forces to improve immunisation coverage for migrants
Memorandum of understanding signed today will strengthen collaboration on vaccination efforts and related health services for migrants and forcibly displaced persons across the world
[See Milestones above for detail]

24 November 2020
Gavi statement on AstraZeneca/Oxford interim efficacy data

 

GHIT Fund [to 28 Nov 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 28 Nov 2020]
https://www.theglobalfund.org/en/news/
News
44th Board Meeting Documents

26 November 2020
The Board of the Global Fund held its Forty-Fourth Meeting on 11-12 November 2020. Documents from the meeting are now available on the 44th Board Meeting page.

COVID-19 Situation Report
24 November 2020
A new issue of the COVID-19 Situation Report is available: Situation Report – 24 November 2020 download in English

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 28 Nov 2020]
https://www.glopid-r.org/news/
News
No new digest content identified.

 

Hilleman Laboratories [to 28 Nov 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 28 Nov 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
Special Issue 3: Interim Efficacy Results Reported for Third COVID-19 Vaccine Candidate
Nov 23, 2020
By Wayne Koff, Ph.D.
President & CEO
AstraZeneca announced results today from an interim analysis of its COVID-19 vaccine candidate that indicate the vaccine is 70% effective on average, according to an ongoing Phase III trial in the U.K. and Brazil. The vaccine candidate is the first of the viral vector platform vaccines to demonstrate efficacy, using an adenovirus that commonly infects chimpanzees to express the SARS-CoV-2 Spike (S) protein. This vaccine was developed in partnership with Oxford University and its spin-off Vaccitech. Both Pfizer/BioNTech and Moderna recently released interim efficacy results for their vaccine candidates, both of which are based on mRNA strategies for delivering vaccine antigens

 

IAVI [to 28 Nov 2020]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
No new digest content identified.

 

 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
Statement on continuation of vaccine trials
Undated – presume week of 23 Nov 2020
[See COVID-19 Vaccine Development above for detail]

 

 

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

 

 

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

 

IFRC [to 28 Nov 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Asia Pacific, Philippines
Typhoon crisis: 305,000 houses wrecked in Philippines
Kuala Lumpur/Manila/Geneva, 26 November 2020 – Consecutive, devastating typhoons in the Philippines have laid the foundations for a long-term humanitarian crisis as more than 305,000 homes have been damaged or destroyed according to humanitarian assess …
26 November 2020

Africa, Ethiopia, Sudan
Sudan: Red Crescent ramps up operation as influx of Ethiopian refugees grows
Khartoum/Nairobi/Geneva, 23 November 2020 – The Sudanese Red Crescent Society has scaled up its operation at the border with Ethiopia to support the growing number of Ethiopian refugees coming into the country. Since fighting began in Ethiopia’s Tigray …
24 November 2020

 

Institut Pasteur [to 28 Nov 2020]
https://www.pasteur.fr/en/press-area
Press documents
Press Info
19.11.2020
COVID-19: neutralizing immune response lasts longer in women than in men
As part of the SEROCoV-HUS study, teams from Strasbourg University Hospital and the Institut Pasteur monitored 308 hospital staff who had previously contracted a mild form of SARS-CoV-2. The scientists demonstrated that neutralizing antibodies could be detected in 84% of them up to 6 months after infection, but that the level fell more quickly in men than in women. These results seem to suggest that immunity lasts longer in women than in men. The study was published as a preprint on the MedRxiv website.

 

IRC International Rescue Committee [to 28 Nov 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Statement
As tensions rise in Mekelle, Ethiopia, IRC warns of impending humanitarian disaster
November 27, 2020

Press Release
IRC welcomes President-Elect Biden’s foreign policy team, urges pressing humanitarian action
November 23, 2020

Press Release
Humanitarian needs in Afghanistan skyrocket amid unrelenting violence and the pandemic; ahead of peace conference, IRC calls on international community to increase funding and push for peace
November 23, 2020

 

IVAC [to 28 Nov 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

 

IVI [to 28 Nov 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
IVI, ROK’s GDEF join forces to provide OCV vaccination to 540,000 people at risk of cholera in Nepal and Mozambique
GDEF’s US$8.05 million grant to support ECHO projects to prevent and control cholera and contribute to ‘Ending Cholera—A Global Roadmap to 2030’   The International Vaccine Institute (IVI) and the Republic of Korea’s Global Disease Eradication Fund (GDEF) have agreed to conduct joint projects to […] 11/26/2020

IVI and the Ministry of Foreign Affairs and Human Mobility of Ecuador exchange MOU to pursue global health research & development
November 24, 2020, SEOUL, Republic of Korea — The International Vaccine Institute (IVI) and the Ministry of Foreign Affairs and Human Mobility of Ecuador exchanged a memorandum of understanding (MOU) today at IVI headquarters in Seoul, Republic of Korea to explore areas of collaboration in […]
11/24/2020

LG Electronics, IVI join forces to conduct a ‘cholera vaccination and prevention project’ in Ethiopia
Project to provide vaccination for 40,000 residents in areas at risk of cholera and establish disease monitoring system with the Ethiopian Ministry of Health through the Armauer Hansen Research Institute (AHRI) To contribute to health authorities in policymaking for disease prevention by investigating waterborne diseases […]
11/24/2020

 

JEE Alliance [to 28 Nov 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 28 Nov 2020]
http://www.msf.org/
Latest [Selected Announcements]
Sudan
MSF providing medical care and assistance in Sudan to people fleein…
Project Update 27 Nov 2020

Iraq
Displaced people in Iraq’s Laylan camp express fears as camp …
Press Release 24 Nov 2020

Coronavirus COVID-19 pandemic
Staff entry restrictions forces MSF to withdraw from COVID-19 response in Venezuela hospital
:: Entry and work permit restrictions for MSF international staff in Venezuela have made it difficult to continue our work on COVID-19.
:: As a result, MSF has been forced to withdraw from the coronavirus COVID-19 response in the Ana Francisca Pérez de León II hospital, Caracas.
:: MSF urges Venezuelan authorities to facilitate the entry of essential international staff into Venezuela to ensure high-level care in the COVID-19 response.

 

National Vaccine Program Office – U.S. HHS [to 28 Nov 2020]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings
December 4, 2020 NVAC Meeting (Virtual)
[See COVID Vaccines Regulatory Meetings/Milestones above]

 

NIH [to 28 Nov 2020]
http://www.nih.gov/news-events/news-releases
News Releases
Fourth iteration of COVID-19 treatment trial underway
November 25, 2020 — Study will enroll hospitalized adults with COVID-19 who require supplemental oxygen.

Commonly used antibiotic shows promise for combating Zika infections
November 24, 2020 — NIH preclinical study suggests FDA-approved tetracycline-based antibiotics may slow infection and reduce neurological problems.

 

PATH [to 28 Nov 2020]
https://www.path.org/media-center/
Press Release
No new digest content identified.

 

Sabin Vaccine Institute [to 28 Nov 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 28 Nov 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
27 November 2020
Study shows how COVID-19 is impacting access to HIV care in the Russian Federation

25 November 2020
New awareness campaign on gender-based violence in the Middle East and North Africa

24 November 2020
Turning around the HIV response in Odessa

23 November 2020
Condom use declining

 

UNICEF [to 28 Nov 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Statement
11/25/2020
Threat of further escalation in Mekelle, Ethiopia, puts children’s lives at risk
Statement by UNICEF Executive Director Henrietta Fore

Press release
11/25/2020
320,000 children and adolescents newly infected with HIV in 2019, 1 every 100 seconds – UNICEF
UNICEF warns of COVID-19 disruptions to HIV service delivery in one third of high burden countries

News note
11/23/2020
COVAX Update: UNICEF working with global airlines and freight providers to plan delivery of COVID-19 vaccines
UNICEF kickstarts discussions with over 350 logistics organizations to step up delivery plans for eventual COVID-19 vaccines
[See COVID Logistics above for details]

Statement
11/23/2020
Millions of children’s lives at high risk as Yemen inches towards famine
Statement by UNICEF Executive Director Henrietta Fore

 

Unitaid [to 28 Nov 2020]
https://unitaid.org/
Featured News
24 November 2020
Unitaid supports ANTICOV, an adaptative platform trial in Africa to treat mild to moderate cases of COVID-19
Geneva –  Unitaid has come together with the German Federal Ministry of Education and Research (BMBF) and the KfW Development Bank to invest in a ground-breaking clinical trial of COVID-19 medicines that are adapted to the needs of low-and middle-income countries.
This innovative trial named ANTICOV will cover 13 countries across Africa and be implemented by a consortium of partners led by Drugs for Neglected Diseases Initiative (DNDi) including 26 African and global research and development organizations.
It seeks to identify treatments that prevent patients with mild to moderate symptoms from progressing to severe disease, thereby reducing transmission of the virus and the need for hospitalisation.
Both outcomes are particularly important in countries with weaker health systems and where quarantine is difficult to implement. Importantly, ANTICOV will look at treatment options for vulnerable people, such as those with coinfections including HIV, TB and malaria.
Most research into COVID-19 medicines is taking place in high-income countries, thereby limiting the development and relevant testing of products adapted to lower-income settings.
Dr. Philippe Duneton, Unitaid’s Executive Director said: “ANTICOV is an important platform to facilitate clinical trials for treatments for COVID-19 in low-resource settings. This is recognised as a key issue by the ACT-A Therapeutics partnership led by Unitaid and Wellcome and will help enable equitable access to medicines against COVID-19 in low- and middle-income countries. Unitaid is pleased to support this important project.”
The trial will evaluate affordable treatments that are already in the market and can be quickly deployed on a large scale. The ultimate goal is to put forward candidate medicines for treatment of mild COVID-19 disease, inform WHO recommendations with conclusive evidence, and support policy change towards test-and-treat strategies for the virus across low- and middle-income countries…

 

Vaccination Acceptance Research Network (VARN) [to 28 Nov 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 28 Nov 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 28 Nov 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

 

Wellcome Trust [to 28 Nov 2020]
https://wellcome.ac.uk/news
No new digest content identified.

 

The Wistar Institute [to 28 Nov 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

 

WFPHA: World Federation of Public Health Associations [to 28 Nov 2020]
https://www.wfpha.org/
Latest News
Producing a Safe and Effective Vaccine: Align Public Health Needs with Economic & Social Development Objectives
Nov 25, 2020
Producing a Safe and Effective Vaccine: Align Public Health Needs with Economic & Social Development Objectives Webinar recording: https://www.youtube.com/watch?v=nIYiXfI0YIo&t=498s

Sheila Tlou Joins Our International Immunization Policy Task Force!
Nov 24, 2020
Sheila Tlou Joins Our International Immunization Policy Task Force! A warm welcome to Prof. Sheila Dinotshe Tlou Co-Chair of The Global HIV Prevention Coalition & Nursing Now on joining WFPHA’s International Immunization Policy Task Force of key…

 

World Organisation for Animal Health (OIE) [to 28 Nov 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
No new digest content identified.

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 28 Nov 2020]
https://alliancerm.org/press-releases/
Press Releases
ARM Responds to EU Pharmaceutical Strategy
November 25, 2020 Washington, DC
The EU Pharmaceutical Strategy recognizes cell and gene therapies as ‘major milestones’ of progress in healthcare, which can durably treat or even cure the most challenging diseases. We are reviewing today’s strategy document in detail and believe that innovative regulatory and payment policies are crucial to ensuring patient access to these transformative therapies. We look forward to engaging with the European Commission and other stakeholders to develop a conducive, holistic environment for advanced therapies and the life-changing benefits they bring to patients.

 

BIO [to 28 Nov 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 28 Nov 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 28 Nov 2020]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 28 Nov 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

 

PhRMA [to 28 Nov 2020]
http://www.phrma.org/
Selected Press Releases, Statements
PhRMA CAREs Grant request for proposals: Addressing racial disparities in medication utilization and adherence
November 24, 2020
Systemic racism is as real as any disease, and our industry is not immune. This summer, in the wake of a national outcry for racial and social justice, our industry offered a firm stance – systemic racism is a disease. As a pharmacist and public health researcher whose motivation stems from advancing health equity – this statement makes me ponder the question, how can our industry help break the harmful patterns of racial inequities?

Press Release
PhRMA Names Debra DeShong Executive Vice President of Public Affairs
November 23, 2020
The Pharmaceutical Research and Manufacturers of America (PhRMA) today named Debra DeShong as executive vice president of public affairs. DeShong will assume the role in mid-December.

Press Release
Committing to diversity, equity and inclusion: A call to action for clinical trials
November 19, 2020
Guest post from Dr. Barbara Bierer, faculty director of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), a Professor of Medicine, Harvard Medical School and Brigham and Women’s Hospital, Boston and a hematologist/oncologist.
The COVID-19 pandemic is the worst public health emergency the world has encountered in over a century and one that has universally impacted the social, political, economic and medical fabric of our lives; it has also exposed significant and systemic health disparities in health care. The disproportionate rates of infection and of disease-related mortality of people of color have been well-documented. Given these disparities, it is critical that trials for COVID-19 vaccines and therapeutics ensure diverse participation. The few exceptions that have been reported, however, prove that recruitment and retention of underserved populations is possible with effort, planning and intentionality of purpose…
…This week PhRMA published a strong statement embracing equity, denouncing racism and putting forth actionable commitments endorsed by its member companies. PhRMA has expanded its Principles on Conduct of Clinical Trials to emphasize and strengthen the commitment to diverse inclusion in clinical trials. The MRCT Center applauds the seriousness with which the problem of health inequities is being addressed, including the call for investments in workforce development and professional opportunities, in changes in trial design and conduct, in community engagement and partnership, in education and in infrastructure. None of these initiatives will succeed, however, unless we appreciate our interdependencies and common interests. We are all and each responsible and must stand together for change.

Journal Watch

Posted on by

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

A simple clinical score to identify likely hepatitis B vaccination non-responders – data from a retrospective single center study

Posted on by

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

 

A simple clinical score to identify likely hepatitis B vaccination non-responders – data from a retrospective single center study
About 10% of Hepatitis B vaccinated individuals mount no protective antibody levels against the hepatitis B surface antigen (HBs-Ag). Older age at primary immunization, obesity and smoking have previously been…
Authors: Marc A. Meier and Christoph T. Berger
Citation: BMC Infectious Diseases 2020 20:891
Content type: Research article
Published on: 25 November 2020

Moral structuring of children during the process of obtaining informed consent in clinical and research settings

Posted on by

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 28 Nov 2020)

 

Moral structuring of children during the process of obtaining informed consent in clinical and research settings
Informed consent is an important factor in a child’s moral structure from which different types of doctor–patient relationships arise. Children’s autonomy is currently under discussion in terms of their decent treatment, beyond what doctors and researchers perceive. To describe the influential practices that exist among clinicians and researchers toward children with chronic diseases during the process of obtaining informed consent.
Authors: Anderson Díaz-Pérez, Elkin Navarro Quiroz and Dilia Esther Aparicio Marenco
Content type: Research article
25 November 2020