Cost-effectiveness of intermittent preventive treatment with dihydroartemisinin-piperaquine versus single screening and treatment for the control of malaria in pregnancy in Papua, Indonesia: a provider perspective analysis from a cluster-randomised trial

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Lancet Global Health
Dec 2020 Volume 8 Number 12 e1444-e1564
http://www.thelancet.com/journals/langlo/issue/current

 

Cost-effectiveness of intermittent preventive treatment with dihydroartemisinin-piperaquine versus single screening and treatment for the control of malaria in pregnancy in Papua, Indonesia: a provider perspective analysis from a cluster-randomised trial
Lucy Paintain, et al.

Meningococcal carriage 7 years after introduction of a serogroup A meningococcal conjugate vaccine in Burkina Faso: results from four cross-sectional carriage surveys

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Lancet Infectious Diseases
Dec 2020 Volume 20 Number 12 p1349-1482, e298-e311
http://www.thelancet.com/journals/laninf/issue/current

 

Meningococcal carriage 7 years after introduction of a serogroup A meningococcal conjugate vaccine in Burkina Faso: results from four cross-sectional carriage surveys
Sarah Mbaeyi, et al.
Open Access

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.

 

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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)

 

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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

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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

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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]