Core commitments for field trials of gene drive organisms

Science
18 December 2020 Vol 370, Issue 6523
http://www.sciencemag.org/current.dtl
Special Issue: 2020 Breakthrough of the Year

 

Policy Forum
Core commitments for field trials of gene drive organisms
By Kanya C. Long, Luke Alphey, George J. Annas, Cinnamon S. Bloss, Karl J. Campbell, Jackson Champer, Chun-Hong Chen, Amit Choudhary, George M. Church, James P. Collins, Kimberly L. Cooper, Jason A. Delborne, Owain R. Edwards, Claudia I. Emerson, Kevin Esvelt, Sam Weiss Evans, Robert M. Friedman, Valentino M. Gantz, Fred Gould, Sarah Hartley, Elizabeth Heitman, Janet Hemingway, Hirotaka Kanuka, Jennifer Kuzma, James V. Lavery, Yoosook Lee, Marce Lorenzen, Jeantine E. Lunshof, John M. Marshall, Philipp W. Messer, Craig Montell, Kenneth A. Oye, Megan J. Palmer, Philippos Aris Papathanos, Prasad N. Paradkar, Antoinette J. Piaggio, Jason L. Rasgon, Gordana Rašić, Larisa Rudenko, J. Royden Saah, Maxwell J. Scott, Jolene T. Sutton, Adam E. Vorsino, Omar S. Akbari
Science18 Dec 2020 : 1417-1419 Full Access
We must ensure that trials are scientifically, politically, and socially robust, publicly accountable, and widely transparent
Summary
Gene drive organisms (GDOs), whose genomes have been genetically engineered to spread a desired allele through a population, have the potential to transform the way societies address a wide range of daunting public health and environmental challenges. The development, testing, and release of GDOs, however, are complex and often controversial. A key challenge is to clarify the appropriate roles of developers and others actively engaged in work with GDOs in decision-making processes, and, in particular, how to establish partnerships with relevant authorities and other stakeholders. Several members of the gene drive community previously proposed safeguards for laboratory experiments with GDOs (1) that, in the absence of national or international guidelines, were considered essential for responsible laboratory work to proceed. Now, with GDO development advancing in laboratories (2–5), we envision similar safeguards for the potential next step: ecologically and/or genetically confined field trials to further assess the performance of GDOs. A GDO’s propensity to spread necessitates well-developed criteria for field trials to assess its potential impacts (6). We, as a multidisciplinary group of GDO developers, ecologists, conservation biologists, and experts in social science, ethics, and policy, outline commitments below that we deem critical for responsible conduct of a field trial and to ensure that these technologies, if they are introduced, serve the public interest.

Reprint of: Air travel and COVID-19 prevention in the pandemic and peri-pandemic period: A narrative review

Travel Medicine and Infectious Diseases
Volume 38 November–December 2020
https://www.sciencedirect.com/journal/travel-medicine-and-infectious-disease/vol/38/suppl/C

 

Review article Open access
Reprint of: Air travel and COVID-19 prevention in the pandemic and peri-pandemic period: A narrative review
Michel Bielecki, Dipti Patel, Jochen Hinkelbein, Matthieu Komorowski, … Patricia Schlagenhauf
Article 101939

Knowledge and Attitudes on Vaccination in Southern Romanians: A Cross-Sectional Questionnaire

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

 

Open Access Article
Knowledge and Attitudes on Vaccination in Southern Romanians: A Cross-Sectional Questionnaire
by Gabriela Loredana Popa, Andrei-Alexandru Muntean, Mădălina-Maria Muntean and Mircea Ioan Popa
Vaccines 2020, 8(4), 774; https://doi.org/10.3390/vaccines8040774 (registering DOI) – 18 Dec 2020
Viewed by 190
Abstract
Vaccines are fundamental instruments upon which all modern medicine is hinged. This has recently come into the light because of the COVID-19 pandemic caused by SARS-CoV-2. We aimed to assess the knowledge and attitudes of the public regarding vaccination. To this end, a […] Read more.

A Review of Adherence and Predictors of Adherence to the CONSORT Statement in the Reporting of Tuberculosis Vaccine Trials

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

 

Open Access Article
A Review of Adherence and Predictors of Adherence to the CONSORT Statement in the Reporting of Tuberculosis Vaccine Trials
by Veranyuy D. Ngah, Akhona V. Mazingisa, Moleen Zunza and Charles S. Wiysonge
Vaccines 2020, 8(4), 770; https://doi.org/10.3390/vaccines8040770 – 16 Dec 2020
Viewed by 172
Abstract
The statement on Consolidated Standards of Reporting Trials (CONSORT) ensures transparency in the reporting of randomized trials. However, it is unclear if the statement has led to improvement in the quality of reporting of tuberculosis (TB) vaccine trials. We explored the quality of […]

Media/Policy Watch

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

 

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 19 Dec 2020
Science
How Science Beat the Virus
And what it lost in the process
Story by Ed Yong
January/February 2021 Issue
As of this writing, the biomedical library PubMed lists more than 74,000 COVID-related scientific papers—more than twice as many as there are about polio, measles, cholera, dengue, or other diseases that have plagued humanity for centuries. Only 9,700 Ebola-related papers have been published since its discovery in 1976; last year, at least one journal received more COVID19 papers than that for consideration. By September, the prestigious New England Journal of Medicine had received 30,000 submissions—16,000 more than in all of 2019. “All that difference is COVID19,” Eric Rubin, NEJM’s editor in chief, says. Francis Collins, the director of the National Institutes of Health, told me, “The way this has resulted in a shift in scientific priorities has been unprecedented.”…

 

BBC
http://www.bbc.co.uk/
Accessed 19 Dec 2020
Covid vaccine: Woman, 108, gets jab for her second pandemic
A 108-year-old woman from Pembrokeshire has received the Covid-19 vaccine for what is the second pandemic of her lifetime.
Mary Keir was one of 37 people at the Llandeilo site to receive their first dose of the Pfizer-Biontech jab.
She was four years old at the onset of the 1916 Spanish Flu outbreak.
Ms Keir said she felt “very lucky” and “much safer and happier” for having received the vaccine.

 

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

 

Financial Times
https://www.ft.com/
Accessed 19 Dec 2020
Coronavirus pandemic
Scientists alarmed at infectiousness of viral variant
Mutations make new strain 70 per cent more transmissible but are not expected to reduce effectiveness of vaccines
December 19, 2020

 

Forbes
http://www.forbes.com/
Accessed 19 Dec 2020
Dec 18, 2020
Poll: 57% Of Americans Say Co-Workers Should Have To Take Coronavirus Vaccine
It is legal for employers in the U.S. to require employees to get vaccinated, with some exceptions.
By Elana Lyn Gross Forbes Staff

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 19 Dec 2020
[No new, unique, relevant content]

 

Foreign Policy
http://foreignpolicy.com/
Accessed 19 Dec 2020
[No new, unique, relevant content]

 

The Guardian
http://www.guardiannews.com/
Accessed 19 Dec 2020
[No new, unique, relevant content]

 

New Yorker
http://www.newyorker.com/
Accessed 19 Dec 2020
Q. & A.
The Influence of the Anti-Vaccine Movement
The virologist Peter Hotez discusses the spread of misinformation about the COVID-19 vaccine.
By Isaac Chotiner
December 18, 2020

 

New York Times
http://www.nytimes.com/
Accessed 19 Dec 2020
Health
C.D.C. Panel Endorses Moderna Vaccine for Americans
The approval sets the stage for widespread inoculations in the United States with a second coronavirus vaccine.
By Katherine J. Wu
PRINT EDITION December 20, 2020

Politics
U.S. General Apologizes for Smaller Vaccine Deliveries in Some States
Gen. Gustave F. Perna, chief operating officer for Operation Warp Speed, apologized after a number of states last week received fewer initial doses of the coronavirus vaccine than planned.
By Reuters December 19, 2020

U.S.
Employers Can Require Workers to Get Covid-19 Vaccine, U.S. Says
The federal Equal Employment Opportunity Commission said employees could be barred from the workplace if they refused the vaccine.
By Vimal Patel Dec. 18

Business
The plan to vaccinate nursing home residents faces a key obstacle: consent.
Dec. 18

 

Washington Post
https://www.washingtonpost.com/
Europe
Israel is starting to vaccinate, but Palestinians may have to wait months
Steve Hendrix and Shira Rubin · Dec 19, 2020

Chinese and Russian vaccines remain unproven — but desperate countries plan to use them anyway
Emily Rauhala, Eva Dou and Robyn Dixon · Dec 19, 2020

Think Tanks et al

Think Tanks et al
 
 
Brookings
http://www.brookings.edu/
Accessed 19 Dec 2020
[No new relevant content]
 
 
Center for Global Development [to 19 Dec 2020]
http://www.cgdev.org/page/press-center
December 17, 2020
Questions on the COVID-19 Vaccine? We’ve Got Answers
At a recent CGD staff presentation of our work into COVID-19 vaccines, our colleagues raised a large number of interesting questions, so, we asked our colleagues to send in their questions on the COVID-19 vaccine portfolio.
Anthony McDonnell and Robert Van Exan
 
 
Chatham House [to 19 Dec 2020]
https://www.chathamhouse.org/
Accessed 19 Dec 2020
COVID-19 Vaccine: Reaching People in Areas Controlled by Armed Groups
Counterterrorism measures do not prohibit the provision of medical assistance – including vaccinations – or engagement with members of ‘terrorist’ groups in order to do so.
Expert Comment
16 December 2020
Emanuela-Chiara Gillard
Associate Fellow, International Law Programme

 

CSIS
https://www.csis.org/
Accessed 19 Dec 2020
Transcript
Online Event: Trusting a Covid-19 Vaccine: Where Do We Stand?
December 18, 2020

 
 
 
Council on Foreign Relations
http://www.cfr.org/
Accessed 19 Dec 2020
December 18, 2020
Pharmaceuticals and Vaccines
What Is the World Doing to Distribute COVID-19 Vaccines?
Governments and researchers have been working with an extremely ambitious timetable to provide billions of people with immunity to the new coronavirus. Now, the first vaccines are being distributed,
Backgrounder by Claire Felter
 
 
Pharmaceuticals and Vaccines
Covering the States’ COVID-19 Vaccine Distribution Plans
Conference Call by Susan Dentzer
December 17, 2020

 
 
 
Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 19 Dec 2020
December 18, 2020 News Release
Federal Rules Protect People from Bills for the COVID-19 Vaccine
As the first doses of the new COVID-19 vaccine are delivered to health care workers and other early recipients, many Americans are eager to know not only when the vaccine will be available to them but also whether they will be able to get it at no cost. The answer…

December 18, 2020 News Release
Poll: Large Majorities Now Say They Wear Masks Regularly and Can Continue Social Distancing for At Least Six Months if Needed, though Republicans Remain Less Likely to Take Such Precautions
As winter sets in and COVID-19 cases and deaths reach records in most parts of the country, more Americans say they wear masks every time they leave home now (73%) than said so in May (52%), a new KFF Health Tracking Poll finds. A small minority (11%) say they wear…

December 16, 2020 News Release
How are States Prioritizing Who Will Get the COVID-19 Vaccine First?
The first Americans were vaccinated today as COVID-19 vaccines are being distributed across the country. A new KFF review of states’ releases and statements about their vaccination priorities finds that most states are following the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices recommendations for the…

December 15, 2020 News Release
KFF Launches New COVID-19 Vaccine Monitor to Track the Public’s Confidence in the Vaccine and Experiences for the Duration of the Pandemic
Republicans and Black Americans are More Likely to Be Hesitant but Even Among These Groups Reasons Vary KFF has launched a new COVID-19 Vaccine Monitor to dive deeply into the public’s views about the vaccine and experiences getting it for as long as the pandemic lasts. First results released today…

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

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

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

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

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

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

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

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

Bill and Melinda Gates call for collaboration, continued innovation to overcome challenges of delivering COVID-19 scientific breakthroughs to the world

Milestones :: Perspectives :: Research

 

Bill and Melinda Gates call for collaboration, continued innovation to overcome challenges of delivering COVID-19 scientific breakthroughs to the world
Gates Foundation pledges additional $250 million to accelerate development and equitable distribution of COVID-19 tests, treatments, and vaccines to end the pandemic

SEATTLE, December 9, 2020 – The Bill & Melinda Gates Foundation today announced it will commit an additional $250 million to support the research, development, and equitable delivery of lifesaving tools in the global effort against COVID-19. Marking the end of a year focused on the scientific breakthroughs needed to end the pandemic, the foundation calls for global commitments to making these innovations available in 2021 to everyone who needs them.

“Everyone, everywhere deserves to benefit from the science developed in 2020,” said Melinda Gates, co-chair of the Gates Foundation. “We are confident that the world will get better in 2021, but whether it gets better for everyone depends on the actions of the world’s leaders and their commitment to deliver tests, treatments, and vaccines to the people who need them, no matter where they live or how much money they have.”

Today’s commitment, the foundation’s largest single contribution to the COVID-19 response to date, builds on the partnerships and expertise it has established over the last 20 years. This funding will support continued innovation to develop tests, treatments, and vaccines that are easier to scale and deliver, to ensure there are many options that are less expensive and can be used in different settings. Today’s commitment will also support the delivery of new COVID-19 tests, treatments, and vaccines, particularly in low- and middle-income countries.

 

Getting these innovations to where they are needed will require the same level of planning, urgency, and collaboration it took to develop them. It will require manufacturing tests, doses of treatments, and vaccines quickly and safely; securing sufficient funding to buy and distribute them; organizing logistical infrastructure and supply chains; preparing clinics and health workers to administer them; and sharing accurate information with communities so people understand and trust what they are receiving. Part of today’s funding will enable countries to use cutting-edge technology and delivery systems to plan and implement the rollout of vaccines. It will also support efforts to engage communities in the process to increase trust and improve communication about new COVID-19 interventions.

“Thanks to the ingenuity of the global scientific community, we are achieving the exciting medical breakthroughs needed to end the pandemic,” said Bill Gates, co-chair of the Gates Foundation. “We have new drugs and more potential vaccines than we could have expected at the start of the year. But these innovations will only save lives if they get out into the world.”

As the world prepares to embark on a global logistical challenge previously unmatched in scale and complexity, it can draw on the expertise of global organizations like Gavi, the Vaccine Alliance and the Global Fund, which have collaborated with governments to deliver vaccines, tests, and treatments against infectious diseases to people in lower-income countries for 20 years. “Fortunately, reaching people with lifesaving tools is something the world knows how to do,” said Melinda Gates.

“The next phase of fighting this pandemic will be much costlier than the initial development of safe and effective vaccines. Our commitment today is only a fraction of what is needed and will be focused on the areas where philanthropy can best add value,” said Gates Foundation CEO Mark Suzman. “Every institution with a role to play has to be generous now. Multilateral organizations, national governments, companies, and philanthropies—we all must invest in making sure the tests, drugs, and vaccines reach as many people as possible.”

The total commitments include:
Today’s announcement brings the foundation’s total commitments to the global COVID-19 response to $1.75 billion. This draws from three sources, including new funding commitments above the foundation’s planned annual program budget; at-risk financing from the foundation’s Strategic Investment Fund; and a portion of funds channeled from foundation programs where grantees identified urgent needs or had unique expertise to mitigate the effects of the pandemic…

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

Milestones :: Perspectives :: Research

 

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

 

Week of 7 December 2020

09 December 2020
Health Canada authorizes first COVID-19 vaccine
…Health Canada received Pfizer’s submission on October 9, 2020 and after a thorough, independent review of the evidence, Health Canada has determined that the Pfizer-BioNTech vaccine meets the Department’s stringent safety, efficacy and quality requirements for use in Canada….

 

09 December 2020
UAE Ministry of Health and Prevention announces official registration of inactivated COVID-19 vaccine used in #4Humanity Trials
ABU DHABI, 9th December, 2020 (WAM) — The UAE’s Ministry of Health and Prevention, MOHAP, has announced the official registration of Beijing Institute of Biological Product’s inactivated COVID-19 vaccine in a major step towards combating the global pandemic. The registration of this vaccine is a decision in response to the application from Sinopharm CNBG. The announcement is a significant vote of confidence by the UAE’s health authorities in the safety and efficacy of this vaccine.
MOHAP, in collaboration with Department of Health Abu Dhabi, DOH, has reviewed Sinopharm CNBG’s interim analysis of the phase III trials, which shows Beijing Institute of Biological Product’s inactivated vaccine to have 86 percent efficacy against COVID-19 infection. The analysis also shows the vaccine to have 99 percent seroconversion rate of neutralising antibody and 100 percent effectiveness in preventing moderate and severe cases of the disease. Furthermore, the analysis shows no serious safety concerns.
This vaccine was granted Emergency Use Authorisation, EUA, since September by MOHAP to protect frontline workers most at risk of COVID-19. The UAE is conducting Post Authorisation Safety Study, PASS, and Post Authorisation Efficacy Study, PAES, of its EUA programme. These ongoing studies show similar safety and efficacy profiles as the interim analysis.
The #4Humanity phase III trials have included 31,000 volunteers across 125 nationalities in the UAE alone. The EUA vaccination programme has effectively safeguarded the UAE frontline workers. MOHAP’s official registration of Beijing Institute of Biological Product’s inactivated COVID-19 vaccine leads the way to comprehensively protecting the population and responsibly opening the economy.

 

11 December 2020
EMA Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU
:: Documents
:: Video recording
Event summary
EMA held 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.
The meeting also gave the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns. This feedback 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 were not covered at this event.

 

12 December 2020
FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine
Today, the FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

 

11-12 December 2020
Advisory Committee on Immunization Practices (ACIP) – CDC
:: Final Agenda – December 12, 2020 pdf icon[1 page]
:: Presentation Slides – December 11-12, 2020
Editor’s Note:
The ACIP approved recommendations for immunization involving the Pfizer-BioNTech COVID vaccine. No official announcement language was posted as of publication time.

Vaccines and Related Biological Products Advisory Committee Meeting

Milestones :: Perspectives :: Research

 

Week of 14 December 2020

 

17 December 2020 – Thursday – 0900-1800/New York
Vaccines and Related Biological Products Advisory Committee Meeting
Meeting Agenda
Tthe Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Moderna, Inc., COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years and older.
The online web conference meeting will be available at the following: 
https://fda.yorkcast.com/webcast/Play/5cf9198bcc0745769b39c699850945911d

 

18-20 December 2020 Times TBC
Advisory Committee on Immunization Practices (ACIP) – CDC
Emergency Meetings if indicated following VRBPAC Meeting on 17 December 2020.

COVID-19 Vaccines :: Development/Procurement/Distribution/Logistics

Milestones :: Perspectives :: Research

 

COVID-19 Vaccines :: Development/Procurement/Distribution/Logistics

Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine programme to improve immune response in the elderly
11 December 2020 Issued: London and Paris
:: Phase 1/2 interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years
:: Insufficient response in older adults demonstrates the need to refine the concentration of antigen in order to provide high-level immune response across all age groups
:: Companies plan a Phase 2b study with an improved antigen formulation
:: With support from BARDA as part of Operation Warp Speed, study to start in February 2021, including a proposed comparison with an authorised COVID-19 vaccine
:: Product availability now expected in Q4 2021 pending successful completion of the development plan

AstraZeneca will test using component of Russia’s Sputnik V in clinical trials of its own vaccine against coronavirus
Press release, 11.12.2020
[See Sputnik below for detail]

Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19 [FDA]
December 11, 2020

U.S. Government Exercises 1st Option for Additional 100 Million Doses of Moderna’s COVID-19 Vaccine Candidate
December 11, 2020

Pfizer and BioNTech Receive FDA Advisory Committee Vote Supporting Potential First Emergency Use Authorization for Vaccine to Combat COVID-19 in the U.S.
December 10, 2020

Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine
December 10, 2020

Moderna Announces First Participants Dosed in Phase 2/3 Study of COVID-19 Vaccine Candidate in Adolescents
December 10, 2020

Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
December 08, 2020

Canada Exercises Increased Option for Total of 40 Million Doses of mRNA Vaccine Candidate Against COVID-19 (mRNA-1273)
December 07, 2020

 

::::::

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 – “Russia’s sovereign wealth fund”].

Sputnik V – “the first registered COVID-19 vaccine” [to 12 Dec 2020]
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
AstraZeneca will test using component of Russia’s Sputnik V in clinical trials of its own vaccine against coronavirus
Press release, 11.12.2020
:: Sputnik V is one of the most effective vaccines globally with over 90% efficacy against coronavirus. The unique feature of the Russian vaccine is the use of two different components based on human adenovirus in two separate inoculations in order to deliver genetic material from the spike of the coronavirus into the human body. This approach provides for a stronger and longer-term immune response compared with vaccines using the same component for both inoculations.
:: On November 23, 2020, following results which showed high efficacy for the Sputnik V vaccine, RDIF and the Gamaleya Center offered AstraZeneca the use of one of the two components of the Sputnik V vaccine.
:: AstraZeneca accepted the proposal by RDIF and the Gamaleya Center to use one of the two vectors of the Sputnik V vaccine in additional clinical trials of its own vaccine, which will commence before the end of this year.

RDIF and Government of Argentina have signed a contract to supply 10 million doses of the Sputnik V vaccine
Press release, 10.12.2020
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) and the Government of Argentina have agreed to supply to the country 10 million doses of Sputnik V, the world’s first registered vaccine against coronavirus.
The vaccine will enable Argentina to secure a diversified portfolio of vaccines against coronavirus. Supplies of the vaccine will be facilitated by international partners of RDIF in India, China, South Korea and other countries…

 

::::::

WHO, national regulators and vaccine manufacturers in South-East Asia Region discuss COVID-19 vaccines
11 December 2020
New Delhi: The World Health Organization, national regulatory authorities and vaccine manufacturers in WHO South-East Asia Region discussed fast tracking of COVID-19 vaccine rollout in Member countries.

“The vaccine manufacturing and regulatory sectors have a critical role to play in equitable and efficient deployment of vaccines,” said Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region, at the two-day virtual meeting that ended today.

The meeting deliberated processes and timelines to fast-track registration of COVID-19 vaccines in countries using the Emergency Use Listing procedures while comprehending the landscape of COVID-19 vaccine production in the Region.

Aimed at strengthening collaboration between national programmes, vaccine producers and regulators in the region for COVID-19 vaccine deployment, the meeting provided a platform for interaction and experience sharing for vaccine registration, deployment and regulation.

The Regional Director said all countries in the Region are now developing and finalizing national deployment and vaccination plans for COVID-19, of which regulatory preparedness is a core component.

 

Establishing expedited regulatory pathways for vaccine approval and adjusting regulatory pathways to the type of vaccine that is developed and filed for approval remains critical as emergency use authorization will precede full licensure, Dr Khetrapal Singh said.

While vaccine licensure systems may need to be modified, having standard operating procedures and stipulated timelines for emergency use authorization would be vital, she said.

The Regional Director emphasized on effective coordination, collaboration and information-sharing. From R&D to production, and from information on country readiness to post-marketing surveillance, manufacturers, regulators, policy-makers and planners must continue to work together to optimize and refine vaccine deployment.

“Countries in our Region are among the world’s largest vaccine manufacturers, and the vaccines produced here are likely to be administered to billions of people globally. I am certain that together, in solidarity with all people of the Region and world, you will effectively contribute to health and well-being of all,” Dr Khetrapal Singh said.

Key global and regional partners such as GAVI and UNICEF participated in the meeting. Among the vaccine manufacturers, from India Bharat Biotech International Ltd, Biological E Ltd, Cadila Healthcare Ltd, Serum Institute of India Pvt. Ltd,  Dr Reddy’s Laboratories and  Wockhardt Limited; from Indonesia Bio Farma Limited, and from Thailand  Government Pharmaceutical Organization (GPO), Bionet Asia Co.Ltd and Siam Bioscience, participated in the meeting.

This was the second such meeting with vaccine manufacturers and regulators organized in WHO South East Asia Region, with the first held in April…

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

EMERGENCIES

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

Weekly Epidemiological and Operational updates
Last update: 5 December 2020, 9:02 am GMT-5
Confirmed cases :: 69 808 588 [week ago: 65 257 767] [two weeks ago: 61 299 371]
Confirmed deaths :: 1 588 854 [week ago: 1 513 179] [two weeks ago: 1 439 784
Countries, areas or territories with cases :: 220

::::::

Weekly epidemiological update – 8 December 2020
Overview
Globally in the past week, cases of COVID-19 have remained at approximately 4 million new cases, while new deaths have continued to increase to over 73 000. This brings the cumulative numbers to over 65.8 million reported cases and 1.5 million deaths globally since the start of the pandemic.

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

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

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 09 December 2020
:: Aidan O’Leary appointed new WHO polio eradication director – Mr Aidan O’Leary will assume the responsibilities of Director for Polio Eradication at WHO, effective 1 January 2021. Mr O’Leary will succeed Mr Michel Zaffran, who will enter a well-deserved retirement end-February 2021.  Mr O’Leary is from Ireland and is currently Head of Office in Yemen for the United Nations Office for the Coordination of Humanitarian Affairs (OCHA). He has served as the Chief of Polio Eradication in Pakistan for UNICEF and spent three years working in Afghanistan (between 2011 and 2014) as Head of Office, OCHA.  He has extensive experience in emergency settings, including in Iraq and Syria, where he also held the position of Head of Office for OCHA.

Summary of new WPV and cVDPV viruses this week (AFP cases and ES postitives):
:: Pakistan: five WPV1 positive environmental samples, six cVDPV2 cases and eight cVDPV2 positive environmental samples
:: Central African Republic: one cVDPV2 case
:: Chad: nine cVDPV2 cases
:: Somalia: one cVDPV2 case

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

WHO Grade 3 Emergencies [to 12 Dec 2020]

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

::::::

WHO Grade 2 Emergencies [to 12 Dec 2020]
Iraq
:: An increasing number of suicide cases in Ira q worries public health experts amid COVID-19 pandemic Baghdad Iraq, 9 December 2020 – The growing number of suicide cases in Iraq over the past years is a worrying public health concern that can no longer be ignored. If not addressed, it will keep taking a heavy toll on individuals and communities in the country…

Burkina Faso
:: L’OMS appuie la revue intra action de la riposte contre la COVID-19 au Burkina Faso
10 décembre 2020

Afghanistan – No new digest announcements identified
Angola – 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 identifie

::::::

WHO Grade 1 Emergencies [to 12 Dec 2020]

Kenya
:: Keeping to the universal health coverage path in Kenya 11 December 2020

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

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

UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: Syrian Arab Republic: COVID-19 Response Update No. 13 – 9 December 2020

Yemen
:: Yemen Situation Report, 9 Dec 2020

::::::

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
COVID-19
:: Coronavirus Disease (COVID-19): Weekly Epidemiological Update (8 December 2020)

East Africa Locust Infestation
:: Desert Locust situation update – 10 December 2020

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

WHO & Regional Offices [to 12 Dec 2020]

WHO & Regional Offices [to 12 Dec 2020]
11 December 2020 Departmental news
Call for Action: Managing the Infodemic
A global movement to promote access to health information and mitigate harm from health misinformation among online and offline communities

11 December 2020 Departmental news
Leading through example: Norway paves the way to ensure equal access to COVID-19 treatments and develops trailblazing flagship initiative on noncommunicable diseases

11 December 2020 News release
WHO, IFRC sign memorandum of understanding on emergency medical teams
The World Health Organization and the International Federation of Red Cross and Red Crescent Societies (IFRC) today launched a new collaboration to strengthen the delivery of emergency medical and health services during humanitarian crises.

11 December 2020 Departmental news
New checklist supports schools to reopen and prepare for COVID-19 resurgences

10 December 2020 Statement
Statement from the ‘civil society’ track of the 3rd Global Infodemic Management Conference

9 December 2020 News release
WHO reveals leading causes of death and disability worldwide: 2000-2019
Noncommunicable diseases now make up 7 of the world’s top 10 causes of death, according to WHO’s 2019 Global Health Estimates, published today. This is an increase from 4 of the 10 leading causes in 2000. The new data cover the period from 2000 to 2019 inclusive.
The estimates reveal trends over the last 2 decades in mortality and morbidity caused by diseases and injuries. They clearly highlight the need for an intensified global focus on preventing and treating cardiovascular diseases, cancer, diabetes and chronic respiratory diseases, as well as tackling injuries, in all regions of the world, as set out in the agenda for the UN Sustainable Development Goals…

8 December 2020 News release
WHO launches year-long campaign to help 100 million people quit tobacco

8 December 2020 Departmental news
Strategic partnerships for global health: Luxembourg and WHO convene strategic dialogue

8 December 2020 Departmental news
Retention of the health workforce in rural and remote areas: a systematic review

7 December 2020 Departmental news
G20 First-time Released Report on Digital Health Interventions for Pandemic Management
The first G20 report in area of digital health, Report on Digital Health Implementation Approach to Pandemic Management, was announced in advent of the G20 Summit. This report promptly outlines digital health emergency responses landscape and proposed actions and implementation recommendations. WHO assumes leadership in multiple strategic recommendation areas in this report, and is committed to support countries to enhance capacity in leveraging digital intervention for emergency response through strengthened international collaboration…he report can be downloaded from digitalhealthtaskforce.org.

7 December 2020 Departmental news
WHO announces forthcoming updates on the systematic screening for tuberculosis

 

::::::

Call for proposals : to publish a series of Market Information for Access (MI4A) reports in peer reviewed journals
Agenda, Policy and Strategy, department of Immunization, Vaccines and Biologicals, World Health Organization
8 December 2020

 

::::::

Weekly Epidemiological Record, 11 December 2020, vol. 95, 50 (pp. 629–640)
Schistosomiasis and soil-transmitted helminthiases: numbers of people treated in 2019

 

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Keeping to the universal health coverage path in Kenya 11 December 2020

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
:: 11 December 2020 News release
WHO, national regulators and vaccine manufacturers in South-East Asia Region discuss COVID-19 vaccines
[See Milestones above for detail]

WHO European Region EURO
:: Youth perspectives in focus at high-level meeting on schooling during COVID-19 pandemic 11-12-2020
:: COVID-19: a stark reminder of the importance of universal health coverage 11-12-2020
:: Cities of the WHO European Region unite to stop COVID-19 and build a better urban life 10-12-2020
:: New data from WHO/Europe shows links between gender and noncommunicable diseases 09-12-2020
:: Italy: over 20% of children are overweight, says new report 09-12-2020
:: COVID-19 and influenza: sharing knowledge across WHO as Europe heads into winter 09-12-2020
:: Schooling in the time of COVID-19: Opening statement at high-level meeting on keeping schools open and protecting all children amid surging COVID-19 cases 08-12-2020
:: Turkey shielded its elderly from COVID-19 by protecting health workers in nursing homes 07-12-2020

WHO Eastern Mediterranean Region EMRO
:: WHO Regional Director’s statement for virtual press briefing, 8 December
8 December 2020 – As winter starts across the Region, the pandemic continues to take a worrying course. A few countries have made progress in controlling the outbreak, while others are still seeing unprecedented increases in the number of cases, and sometimes even the number of deaths. Following a sharp increase in the number of cases over the past few week, Islamic…
:: Islamic Advisory Group reiterates commitment to polio eradication amid COVID-19 pandemic
7 December 2020, Jeddah, Saudi Arabia ‒ The Islamic Advisory Group for Polio Eradication (IAG) in its seventh annual meeting acknowledged the unprecedented challenges to polio eradication posed by the disruptions to health care delivery, including to routine immunization and polio vaccination campaigns, as a result of the COVID-19 pandemic. The IAG noted with concern that children were becoming increasingly…

WHO Western Pacific Region
No new digest content identified

Africa CDC [to 12 Dec 2020]

Africa CDC [to 12 Dec 2020]
http://www.africacdc.org/
News
Press Releases
European Union and African Union sign partnership to scale up preparedness for health emergencies
BRUSSELS, BELGIUM, 7 DECEMBER 2020. Today, the European Centre for Disease Prevention and Control (ECDC) and the Africa Centres for Disease Control and Prevention (Africa CDC) launched a new partnership initiative to strengthen the capacity of Africa CDC to prepare for and respond to public health threats in Africa. The four-year project, ‘EU for health security in Africa: ECDC for Africa CDC’, funded by the EU, will also facilitate harmonised surveillance and disease intelligence, and support the implementation of the public health workforce strategy of Africa CDC…

China CDC

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

National Health Commission of the People’s Republic of China [to 12 Dec 2020]
http://en.nhc.gov.cn/
News
Dec 12: Daily briefing on novel coronavirus cases in China
On Dec 11, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 13 new cases of confirmed infections.

National Medical Products Administration [to 12 Dec 2020]
http://english.nmpa.gov.cn/news.html
News
No new digest content identified.

Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 12 Dec 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 12 Dec 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
December 11, 2020: Trump Administration purchases additional 100 million doses of COVID-19 investigational vaccine from Moderna

 

BMGF – Gates Foundation [to 12 Dec 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
DECEMBER 09, 2020
Bill and Melinda Gates call for collaboration, continued innovation to overcome challenges of delivering COVID-19 scientific breakthroughs to the world
Gates Foundation pledges additional $250 million to accelerate development and equitable distribution of COVID-19 tests, treatments, and vaccines to end the pandemic
[See Milestones above for detail]

 

Bill & Melinda Gates Medical Research Institute [to 12 Dec 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
NEWS RELEASE 12/9/20
MEDICINES PATENT POOL SUBLICENSES SUTEZOLID, AN INVESTIGATIONAL DRUG FOR TB TREATMENT, PAVING THE WAY FOR CLINICAL DEVELOPMENT
Geneva and Cambridge MA– (Wednesday 9 December 2020) –The Medicines Patent Pool (MPP) and the Bill & Melinda Gates Medical Research Institute (Gates MRI) signed an agreement today to advance the development of investigational sutezolid-containing TB drug regimens, especially for low- and middle-income countries, where most people with TB live. The drug candidate sutezolid, in combination with other drugs, could potentially be used as an all-oral, shortened regimen for all forms of TB, including multidrug-resistant TB (MDR-TB).
In October 2019, MPP and Pfizer entered into a license agreement, which granted MPP rights to sublicense to third parties the patents and know-how relating to the use of sutezolid (formerly known as PNU-100480), a promising antibiotic drug candidate, in combination with other agents for the prevention and/or treatment of TB. Gates MRI is the first recipient of such a sublicense. The sublicence allows Gates MRI to access Pfizer’s existing preclinical, phase 1 and phase 2a clinical study data and results with the aim of further developing this potential component of future TB regimens, should the data be supportive…

 

CARB-X [to 12 Dec 2020]
https://carb-x.org/
News
12.08.2020  |
CARB-X honored with award from the Global Health Technologies Coalition for progress made in accelerating R&D to combat drug-resistant bacteria
CARB-X has been awarded the 2020 Partnership Award by the Global Health Technologies Coalition (GHTC) for its work in accelerating R&D. The award recognizes CARB-X’s progress in expanding the pipeline of innovation that address one of the world’s most pressing public health crises, antibiotic-resistant bacteria.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 12 Dec 2020]
http://cepi.net/
Latest News
CEPI statement on University of Queensland and CSL COVID-19 vaccine candidate
10 Dec 2020

CEPI and SK bioscience extend collaboration to develop ‘next generation’ COVID-19 vaccine
This collaboration represents CEPI’s first next-generation or ‘Wave 2’ vaccine investment
09 Dec 2020

 

EDCTP [to 12 Dec 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
No new digest content identified.

 

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

 

European Medicines Agency [to 12 Dec 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 2020
CHMP, Last updated: 11/12/2020

 

 

News: Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025
Last updated: 08/12/2020
… The European medicines agencies network strategy to 2025 outlines six priority areas for the network:
:: the availability and accessibility of medicines;
:: data analytics, digital tools and digital transformation;
:: innovation;
:: antimicrobial resistance and other emerging health threats;
:: supply chain challenges; and
:: the sustainability of the network and operational excellence…

 

European Vaccine Initiative [to 12 Dec 2020]
http://www.euvaccine.eu/
Latest News
Dec 10 2020
Value of Vaccines campaign 2020: Collaboration- the key to efficient vaccine development

 

FDA [to 12 Dec 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
December 11, 2020 – FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine
… “The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”…

December 11, 2020 – FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution…

December 10, 2020 – Coronavirus (COVID-19) Update: December 10, 2020

December 10, 2020 – Coronavirus (COVID-19) Update: FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data

December 9, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System

December 8, 2020 – Coronavirus (COVID-19) Update: December 8, 2020

 

FDA – COVID-19 Vaccines [to 12 Dec 2020]
www.fda.gov/covid19vaccines
Upcoming Events
12/17/2020:
Vaccines and Related Biological Products Advisory Committee Meeting

12/12/2020:
Virtual Press Conference: First COVID-19 Vaccine External Link Disclaimer
As part of the FDA’s commitment to transparency, we invite you to watch our virtual press conference, to be live streamed over the FDA’s YouTubeExternal Link Disclaimer, FacebookExternal Link Disclaimer and TwitterExternal Link Disclaimer accounts on December 12, 2020, at 9:00 AM ET.

12/11/2020:
FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine
Today, the FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

[See Regulatory Calendar above for details]

 

Fondation Merieux [to 12 Dec 2020]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation co-organized event
Vaccine Acceptance Virtual Event Series – How to maintain and build trust in immunization
December 16, 2020 – 2:00pm – 4:30pm (CET) Virtual
An event to continue the dialogue and increase multi-sectoral efforts to promote vaccination acceptance and immunization programs resilience, now particularly challenged by the ongoing COVID-19 pandemic.
The erosion in vaccination trust and additional disruptions in routine immunization programs caused by the current pandemic is becoming an increasing threat to public health. How to tackle it?
To keep the momentum in this critical topic, we would like to bring together the vaccine acceptance public in this 2.5-hour webinar.

 

Gavi [to 12 Dec 2020]
https://www.gavi.org/
News releases
What do immunity passports and vaccination certificates mean for COVID-19 restrictions?
Here’s why continuing to physically distance and wear masks is vital until we can be sure how long vaccine-acquired immunity lasts.
11 December 2020
An immunity passport is an official document that certifies “an individual has been infected and is purportedly immune to SARS-CoV-2.” In principle, this can then give an individual more freedom to travel and socialise, allowing people to enter a country if they can provide evidence that they have already recovered from COVID-19.
The theory is that by providing proof of a positive and then a negative test, the person will have had the disease and is expected to have developed antibodies or other forms of immune memory to protect them from getting ill again.
Hungary has introduced a policy allowing people to enter the country if they can provide evidence that they have already recovered from COVID-19. Iceland is planning on introducing a similar policy that will allow people who have already had COVID-19 to be exempt from the nationwide mask mandate. This raises difficult questions as some people with underlying health conditions, including autism, panic disorders and breathing difficulties, are already exempt from wearing a mask but have not necessarily recovered from infection or have any immunity to it.
In April, the World Health Organization (WHO) cautioned against the use of immunity passports saying: “there is not enough evidence about the effectiveness of antibody-mediated immunity to guarantee the accuracy of an ‘immunity passport’ or ‘risk-free certificate’.” It recently confirmed that this position has not changed.
WHO also suggested that immunity passports could in fact increase the risks of continued transmission, because those carrying one would ignore public health advice about physically distancing.
Immunity passports also raise ethical issues due to concerns that documentation could be fraudulently reproduced, and could even incentivise otherwise healthy people to “willfully seek out infection” so they could enjoy more freedom….

 

GHIT Fund [to 12 Dec 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
Press Releases
December 8, 2020
GHIT Fund Announces New Investments: A Total of 230 Million Yen in Drugs for Malaria and Chagas Disease
The Global Health Innovative Technology (GHIT) Fund announced today a total of approximately 230 million yen (US$2.2 million*) to invest in four partnerships to develop new lifesaving drugs for malaria and Chagas disease. This includes three new projects and one that will receive continued funding.

 

Global Fund [to 12 Dec 2020]
https://www.theglobalfund.org/en/news/
News
No new digest content identified.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 12 Dec 2020]
https://www.glopid-r.org/news/
News
GloPID-R appoints new Chair and Vice Chairs to lead the network’s Board
05/11/2020
GloPID-R is delighted to announce that Dr. Charu Kaushic has been appointed Chair of the network following the excellent work carried out by Prof. Yazdan Yazdanpanah over the past two years. Prof. Yazdanpanah will continue to serve GloPID-R as a Vice Chair.

 

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

 

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

 

IAVI [to 12 Dec 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
No new digest content identified.

 

 

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

 

 

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

 

IFRC [to 12 Dec 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
WHO, IFRC sign memorandum of understanding on emergency medical teams
The World Health Organization and the International Federation of Red Cross and Red Crescent Societies (IFRC) today launched a new collaboration to strengthen the delivery of emergency medical and health services during humanitarian crises.
WHO Director-General Dr Tedros Adhanom Ghebreyesus and IFRC Secretary-General Mr Jagan Chapagain signed a memorandum of understanding to cooperate on implementing the Emergency Medical Team (EMT) initiative.
“We thank the IFRC for their support from the onset of the EMT Initiative and we look forward to this continued partnership in improving the quality of care in emergencies,” said Dr Tedros. “With the COVID-19 pandemic and the significant increase in emergencies around the world, this agreement could not come at a better time.”
Mr Chapagain said IFRC was committed to working side-by-side with WHO in providing life-saving health services to communities affected by humanitarian emergencies.
“This MoU will allow us to standardize our emergency health response work and provide increased support for National Red Cross and Red Crescent Societies which play such a crucial role in emergency response,” Mr Chapagain said. “We are very committed to working together with WHO to provide quality emergency health services that communities desperately need in times of crisis.”
The MoU, also known as the Red Channel Agreement, is the culmination of years of collaboration between IFRC and the WHO Emergency Medical Team Initiative.
The new agreement will bring more synergies to health emergency response between the two international organizations, particularly in technical standards, accountability, and coordination.
It aligns the IFRC’s system with that of the WHO Emergency Medical Teams global classification system, in doing so recognizing the IFRC’s Emergency Response Units as EMTs and heightens the involvement of IFRC teams and National Red Cross and Red Crescent Societies in the capacity building efforts of the EMT network.

Campaign showcases how cash assistance helps refugees in Turkey regain control of their lives
Ankara/Berlin/Geneva, 8 December 2020 – A digital campaign that connects inspiring and talented refugees in Turkey with influencers across Europe has been launched today by the International Federation of Red Cross Red Crescent Societies (IFRC). The ca …
8 December 2020

 

Institut Pasteur [to 12 Dec 2020]
https://www.pasteur.fr/en/press-area
Press documents
09.12.2020
Gut microbiota plays a role in brain function and mood regulation
Depression is a mental disorder that affects more than 264 million people of all ages worldwide. Understanding its…

 

IRC International Rescue Committee [to 12 Dec 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Statement
IRC statement on death of staff member in Ethiopia
December 10, 2020

Press Release
Experts declare ‘famine like conditions’ for almost 17,000 people in Yemen, warns IRC
December 3, 2020

 

IVAC [to 12 Dec 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
Webinar Recording: How will COVID-19 Vaccines be Deployed in Maryland and the U.S.?
December 2020
The International Vaccine Access Center (IVAC) hosted a webinar on October 21 2020 , “How will COVID-19 Vaccines be Deployed in Maryland and the U.S.? A conversation with state and local leaders working to equitably allocate vaccines in 2020 and beyond.” Description: This online panel about COVID-19 vaccine allocation in Maryland and the U.S. was […]

 

IVI [to 12 Dec 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

 

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

 

MSF/Médecins Sans Frontières [to 12 Dec 2020]
http://www.msf.org/
Latest [Selected Announcements]
Photo Story
A year in pictures 2020
11 Dec 2020

 

National Vaccine Program Office – U.S. HHS [to 12 Dec 2020]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
December 2020:
Preparing for COVID-19 Vaccination: Recommendations from the National Vaccine Advisory Committee – PDF
Approved December 4, 2020 :: 15 pages
CONCLUSION
The COVID-19 pandemic has created an unprecedented need for safe and effective vaccines, among other valuable public health interventions, to prevent further disease transmission and return society fully to normal activities. Many lessons have already emerged from the pandemic that showcase needs to innovate our processes for developing new and improved vaccines, as well as strengthen vaccine communication efforts and confidence in vaccines. Likewise, as the vaccine development process progresses, planning to include children and pregnant women in vaccination clinical trials poses special considerations. The NVAC reviewed, discussed, and approved the recommendations in this report to help ensure these efforts related to COVID-19 vaccination are successful and that we build on efforts to improve the U.S. vaccination system.

 

NIH [to 12 Dec 2020]
http://www.nih.gov/news-events/news-releases
News Releases
Baricitinib plus remdesivir shows promise for treating COVID-19
December 11, 2020 — Peer-reviewed results of NIH clinical trial published.

NIH’s All of Us Research Program returns first genetic results to participants
December 10, 2020 — Personalized insights include genetic ancestry and traits, with health-related results to come.

NIH to fund cohort recruitment and development program to enhance diversity and inclusion among biomedical faculty
December 8, 2020 — Groups include underrepresented racial and ethnic groups, individuals with disabilities, individuals from disadvantaged backgrounds, and women.

NIH-funded tool helps organizations plan COVID-19 testing
December 7, 2020 — Online calculator computes costs of testing and offers strategies for preventing infections in schools and businesses.

 

PATH [to 12 Dec 2020]
https://www.path.org/media-center/
Press Release
Advancing Zambia’s goal to end malaria, PATH receives new award from the President’s Malaria Initiative
A new cooperative agreement will accelerate malaria burden reduction and elimination goals in Zambia.
December 8, 2020 by PATH

 

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

 

UNAIDS [to 12 Dec 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
11 December 2020
The shero of Butha-Buthe: Matšeliso Setoko

9 December 2020
PrEP in the City: campaign for transgender women aims to increase PrEP uptake in Thailand

7 December 2020
New HIV infections among gay men and other men who have sex with men increasing

 

UNICEF [to 12 Dec 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Press release 12/11/2020
Update on UNICEF’s response for Ethiopian refugees in Sudan and host communities

Press release 12/11/2020
Child poverty will remain above pre-COVID levels for at least five years in high-income countries – UNICEF
In high-income countries, only 2 per cent of fiscal stimulus was allocated specifically to support children during the first wave of COVID-19; a better balance of spending that provides more direct support to children is urgently needed

Statement 12/10/2020
Life a ‘waking nightmare’ for 12 million children in Yemen
UNICEF Executive Director Henrietta Fore’s remarks at the Averting famine in Yemen: What can we do now and in 2021 event

Press release 12/07/2020
COVID-19: UNICEF warns of continued damage to learning and well-being as number of children affected by school closures soars again
UNICEF calls on governments to prioritize the reopening of schools, take all actions possible to make classrooms as safe as possible and avoid nationwide school closures

 

Unitaid [to 12 Dec 2020]
https://unitaid.org/
11 December 2020
Strategy development launched and new areas for intervention agreed at 37th meeting of Unitaid’s Executive Board
…The Board has approved an external review as an important step towards the development of Unitaid’s next strategy. As a key component of this process, extensive stakeholder engagement will be undertaken throughout 2021, to gain the thoughts and inputs of Unitaid’s partners, grant implementers and civil society groups.
The new areas for intervention agreed by the Board focus on challenges that are deeply relevant to Unitaid’s core work, namely reducing the number of women who die in pregnancy or childbirth, and increasing the detection of TB…

09 December 2020
Annual report: Advancing global health in the age of COVID-19

08 December 2020
Unitaid ranked as one of the world’s leaders in funding tuberculosis research

 

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

 

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

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 12 Dec 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
News
Five ways to build confidence in vaccines
Heidi Larson, Director, Vaccine Confidence Project
With potential new vaccines for COVID-19 on the horizon, we need to engage with public to understand their concerns and build vaccine confidence.

“Vaccinate, liberate!” That could be the rally cry to mobilise public enthusiasm around the remarkable and rapid scientific progress that has made it possible to have not just one, but multiple, new COVID-19 vaccines. Vaccines which will finally help the world get back to some semblance of “normal” – or at least start the COVID-19 recovery path to a “new normal.”

Just think – we would be able to go back to work, get the economy back on track, spend cherished time with friends and families, attend sports events, go to concerts, and travel!

Addressing the challenges around vaccination
But not everyone is celebrating the value of vaccines. Some of the same people protesting against lockdown, and even masks, are also seeing vaccination as a form of control; ironically the one thing that has the potential to free us from the constraints of lockdown as well as, most importantly, freedom from disease.

This is one of many examples – including, but beyond COVID-19 – where there are vastly different, often polarised, interpretations of vaccines and vaccination.

Most people believe in the value of vaccines more broadly, with some having questions or concerns around one vaccine, but not others. There are some who are staunchly against vaccines, or at least opposed to the ways in which vaccines are regulated, recommended sometimes required by government.

These sentiments are not new to vaccines. The first organised “anti-vaccine” movement in the 1800s was actually call the “anti-compulsory vaccine league.” The protest was not against the vaccine, per se, but about the mandate requiring it.

The impact of coronavirus on routine vaccination
The pandemic has been a time when most governments have called for exceptional measures, limiting freedom of movement and socialisation, stopping some workplaces, even schools from opening – all to protect the public’s health.

In the meantime, many routine vaccines have fallen behind with all the restrictions and difficult access, alongside fear of contagion.

I propose five ways to build confidence, not only in a COVID-19 vaccine but pave the way for a new relationship around vaccines and the public.
1) Listen: There are many different experiences, histories, beliefs, perceptions and genuine questions around vaccines. Listen to them, they may reveal more than you expected and help understand what is driving those beliefs.
2) Engage: Make communication a dialogue, engage multiple people in the community outside of the health services to be listeners, and help address concerns and questions.
3) Innovate: Try something different than you have ever tried before. Try to think of anything else that is like a vaccine, think of metaphors. Does anything come close?
4) Co-create: Involve those who are meant to get vaccines in designing the best strategy to reach them and their peers.
5) Vaccinate Liberate: Think of all the ways that vaccination is a passport to freedom.

 

Wellcome Trust [to 12 Dec 2020]
https://wellcome.ac.uk/news
No new digest content identified.

 

The Wistar Institute [to 12 Dec 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

 

WFPHA: World Federation of Public Health Associations [to 12 Dec 2020]
https://www.wfpha.org/
Latest News
Being Rich and Sick Is Much Better than Being Poor and Sick!
Dec 10, 2020
Being Rich and Sick Is Much Better than Being Poor and Sick! With more vaccines on the way, we can see an end to the COVID-19 pandemic. But it remains to be seen how the vaccines will be distributed.

COVID-19 Vaccination: A Question about Global Equity in Health
Dec 8, 2020
COVID-19 Vaccination: A Question about Global Equity in HealthCOVID-19 has had no respect for borders! Vaccines against COVID-19 will be a scarce good, at least for some time ahead. Therefore, both in order to achieve the best possible population…

16th World Congress on Public Health: Personal Experiences
Dec 7, 2020
16th World Congress on Public Health: Personal ExperiencesIn October, several interns from the World Federation of Public Health Associations (WFPHA) were invited to help organize and attend the virtual 16th World Congress on Public Health (WCPH…

 

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

 

 

::::::

 

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

 

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

 

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

 

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

 

IFPMA [to 12 Dec 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Speak Up Africa and IFPMA launch the “Africa Young Innovators for Health Award” to fuel
08 December 2020

 

 

Pharma innovation delivers COVID-19 solutions beyond expectations, but calls for the dilution of intellectual property rights are counterproductive
08 December 2020

A broad alliance, a crucial mission: A new multi-stakeholder association to combat falsified medicines
07 December 2020

 

PhRMA [to 12 Dec 2020]
http://www.phrma.org/
Selected Press Releases, Statements
New analysis finds stark difference in coverage of breast cancer medicines for seniors in the United States and England
Nicole Longo   |     December 10, 2020

Eli Lilly and Company Chairman and CEO David Ricks Becomes PhRMA Board Chairman
December 9, 2020
The Pharmaceutical Research and Manufacturers of America (PhRMA) is pleased to announce that David Ricks, chairman and CEO of Eli Lilly and Company, has assumed the role of chairman of the PhRMA board of directors.

Guest post: How COVID-19 underscores the importance of public confidence in vaccines
Guest Contributor   |     December 7, 2020
Serese Marotta, Chief Operating Officer for Families Fighting Flu, about the importance of influenza vaccination.

Journal Watch

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

Socially Situated Brain Death

AMA Journal of Ethics
Volume 22, Number 12: E981-1070
https://journalofethics.ama-assn.org/issue/socially-situated-brain-death

 

Socially Situated Brain Death
In 1980, the Uniform Determination of Death Act (UDDA) defined death as “(1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem … in accordance with accepted medical standards.” Interpreting the UDDA definition and applying neurological criteria for diagnosing brain death sound straightforward. Brain death is, however, socially situated, not observer independent, and fraught with uncertainty and ambiguity. This issue investigates some of the ethical, cultural, and legal complexities of one of medicine’s most critical tasks: being sharp and sure about who is alive and who is dead.
Full Issue PDF

Infection and mortality of healthcare workers worldwide from COVID-19: a systematic review (4 December, 2020)

BMJ Global Health
December 2020 – Volume 5 – 12
https://gh.bmj.com/content/5/12

 

Original research
Infection and mortality of healthcare workers worldwide from COVID-19: a systematic review (4 December, 2020)
Soham Bandyopadhyay, Ronnie E Baticulon, Murtaza Kadhum, Muath Alser, Daniel K Ojuka, Yara Badereddin, Archith Kamath, Sai Arathi Parepalli, Grace Brown, Sara Iharchane, Sofia Gandino, Zara Markovic-Obiago, Samuel Scott, Emery Manirambona, Asif Machhada, Aditi Aggarwal, Lydia Benazaize, Mina Ibrahim, David Kim, Isabel Tol, Elliott H Taylor, Alexandra Knighton, Dorothy Bbaale, Duha Jasim, Heba Alghoul, Henna Reddy, Hibatullah Abuelgasim, Kirandeep Saini, Alicia Sigler, Leenah Abuelgasim, Mario Moran-Romero, Mary Kumarendran, Najlaa Abu Jamie, Omaima Ali, Raghav Sudarshan, Riley Dean, Rumi Kissyova, Sonam Kelzang, Sophie Roche, Tazin Ahsan, Yethrib Mohamed, Andile Maqhawe Dube, Grace Paida Gwini, Rashidah Gwokyala, Robin Brown, Mohammad Rabiul Karim Khan Papon, Zoe Li, Salvador Sun Ruzats, Somy Charuvila, Noel Peter, Khalil Khalidy, Nkosikhona Moyo, Osaid Alser, Arielis Solano, Eduardo Robles-Perez, Aiman Tariq, Mariam Gaddah, Spyros Kolovos, Faith C Muchemwa, Abdullah Saleh, Amanda Gosman, Rafael Pinedo-Villanueva, Anant Jani, Roba Khundkar

Systematic literature review of the impact and effectiveness of monovalent meningococcal C conjugated vaccines when used in routine immunization programs

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles

 

Research article
Systematic literature review of the impact and effectiveness of monovalent meningococcal C conjugated vaccines when used in routine immunization programs
Monovalent meningococcal C conjugate vaccine (MCCV) was introduced into the routine immunization program in many countries in Europe and worldwide following the emergence of meningococcal serogroup C (MenC) in…
Authors: Myint Tin Tin Htar, Sally Jackson, Paul Balmer, Lidia Cristina Serra, Andrew Vyse, Mary Slack, Margarita Riera-Montes, David L. Swerdlow and Jamie Findlow
Citation: BMC Public Health 2020 20:1890
Published on: 9 December 2020

Antibiotic resistance and persistence—Implications for human health and treatment perspectives

EMBO Reports
Volume 21 Issue 12 3 December 2020
https://www.embopress.org/toc/14693178/current

 

Review 8 December 2020
Antibiotic resistance and persistence—Implications for human health and treatment perspectives
Markus Huemer, Srikanth Mairpady Shambat, Silvio D Brugger, Annelies S Zinkernagel
Bacteria that survive antibiotics challenges are one of the greatest threats to human health. While antibiotic resistance has been well studied, the survival and re‐growth of fully susceptible bacteria, called antibiotic persistence, is less well understood. This review discusses the mechanisms and implications of antibiotic resistance and persistence.

Public health and corporate social responsibility: exploratory study on pharmaceutical companies in an emerging market

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 12 Dec 2020]

 

Research
Public health and corporate social responsibility: exploratory study on pharmaceutical companies in an emerging market
Corporate social responsibility (CSR) is studied from many perspectives and has gained unprecedented importance in recent years, especially in emerging economies. Pharmaceutical companies play a very important role in a population’s well-being and health through the CSR and corporate governance practices that they apply.
Authors: Tatiana Dănescu and Maria-Alexandra Popa
10 December 2020

Analyzing the Human Rights Impact of Increased Digital Public Health Surveillance during the COVID-19 Crisis

Health and Human Rights
Volume 22, Issue 2, December 2020
https://www.hhrjournal.org/volume-22-issue-2-december-2020/

 

Special Section: Big Data, Technology, Artificial Intelligence and the Right to Health
Analyzing the Human Rights Impact of Increased Digital Public Health Surveillance during the COVID-19 Crisis
Sharifah Sekalala, Stéphanie Dagron, Lisa Forman, and Benjamin Mason Meier
The COVID-19 pandemic has led policy makers to expand traditional public health surveillance to take advantage of new technologies, such as tracking apps, to control the spread of SARS-CoV-2. This article explores the human rights dimensions of how these new surveillance technologies are being used and assesses the extent to which they entail legitimate restrictions to a range of human rights, including the rights to health, life, and privacy. We argue that human rights offer a crucial framework for protecting the public from regulatory overreach by ensuring that digital health surveillance does not undermine fundamental features of democratic society…

Human Rights and Digital Health Technologies

Health and Human Rights
Volume 22, Issue 2, December 2020
https://www.hhrjournal.org/volume-22-issue-2-december-2020/

 

Human Rights and Digital Health Technologies
Nina Sun, Kenechukwu Esom, Mandeep Dhaliwal, and Joseph J. Amon
…The COVID-19 pandemic has led policy makers to expand traditional public health surveillance to take advantage of new technologies, such as tracking apps, to control the spread of SARS-CoV-2. This article explores the human rights dimensions of how these new surveillance technologies are being used and assesses the extent to which they entail legitimate restrictions to a range of human rights, including the rights to health, life, and privacy. We argue that human rights offer a crucial framework for protecting the public from regulatory overreach by ensuring that digital health surveillance does not undermine fundamental features of democratic society.

From Information to Valuable Asset: The Commercialization of Health Data as a Human Rights Issue

Health and Human Rights
Volume 22, Issue 2, December 2020
https://www.hhrjournal.org/volume-22-issue-2-december-2020/

 

VIEWPOINTS
From Information to Valuable Asset: The Commercialization of Health Data as a Human Rights Issue
Amy Dickens
Health data is a valuable source of knowledge that states can use to advance or undermine the right to health. But the sources and use of health data are changing in our emerging global data economy. Novel forms of digitized health information are fueling a booming industry for algorithmic technologies in health care, rendering it a huge source of scientific and commercial value. To date, the tech giants—Google, Apple, Microsoft, Facebook, and Amazon—are way ahead of public health systems in capitalizing on this value. There is an urgent need for states to recognize the value of health data and use it to advance human rights. Failing to do so risks private actors gaining ever more expansive monopoly powers that threaten patients’ social and economic rights.

Disability inclusion in humanitarian action

Humanitarian Exchange Magazine
Number 78, October 2020
https://odihpn.org/magazine/inclusion-of-persons-with-disabilities-in-humanitarian-action-what-now/

 

Disability inclusion in humanitarian action
by HPN October 2020
The theme of this edition of Humanitarian Exchange, co-edited with Sherin Alsheikh Ahmed from Islamic Relief Worldwide, is disability inclusion in humanitarian action. Persons with disabilities are not only disproportionately impacted by conflicts, disasters and other emergencies, but also face barriers to accessing humanitarian assistance. At the same time, global commitments and standards and the IASC Guidelines on the inclusion of persons with disabilities in humanitarian action all emphasise how persons with disabilities are also active agents of change. Disability and age-focused organisations have led on testing and demonstrating how inclusion can be done better. Yet despite this progress, challenges to effective inclusion remain.

As Kirstin Lange notes in the lead article, chief among these challenges is humanitarian agencies’ lack of engagement with organisations of persons with disabilities. Simione Bula, Elizabeth Morgan and Teresa Thomson look at disability inclusion in humanitarian response in the Pacific, and Kathy Al Jubeh and Alradi Abdalla argue for a ‘participation revolution’, building on learning from the gender movement. Tchaurea Fleury and Sulayman AbdulMumuni Ujah outline how the Bridge Article 11 training initiative is encouraging constructive exchange between humanitarian and disability actors. The lack of good, disaggregated data is highlighted by Sarah Collinson; Frances Hill, Jim Cranshaw and Carys Hughes emphasise the need for training resources in local languages and accessible formats; and Sophie Van Eetvelt and colleagues report on a review of the evidence on inclusion of people with disabilities and older people.

Rebecca Molyneux and co-authors analyse the findings of a review of a DFID programme in north-east Nigeria, while Carolin Funke highlights the importance of strategic partnerships between disability-focused organisations, drawing on her research in Cox’s Bazar. Sherin Alsheikh Ahmed describes Islamic Relief Worldwide’s approach to mainstreaming protection and inclusion, while Pauline Thivillier and Valentina Shafina outline IRC’s Client Responsive Programming. The edition ends with reflections by Mirela Turcanu and Yves Ngunzi Kahashi on CAFOD’s SADI approach.

A Proposed Framework and Timeline of the Spectrum of Disease Due to SARS-CoV-2 InfectionIllness Beyond Acute Infection and Public Health Implications

JAMA
December 8, 2020, Vol 324, No. 22, Pages 2238-2334
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
A Proposed Framework and Timeline of the Spectrum of Disease Due to SARS-CoV-2 InfectionIllness Beyond Acute Infection and Public Health Implications
S. Deblina Datta, MD; Amish Talwar, MD, MPH; James T. Lee, MD, MSc
free access has active quiz
JAMA. 2020;324(22):2251-2252. doi:10.1001/jama.2020.22717
This Viewpoint uses clinical observations of the natural course of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection to propose 3 phases of illness: acute infection (what people commonly refer to with the COVID-19 designation); postacute hyperinflammatory illness (referred to clinically as multisystem inflammatory syndrome); and late inflammatory sequelae, manifest as enduring cardiac, neurological, and psychological symptoms.

Science Denial and COVID Conspiracy TheoriesPotential Neurological Mechanisms and Possible Responses

JAMA
December 8, 2020, Vol 324, No. 22, Pages 2238-2334
https://jamanetwork.com/journals/jama/currentissue

 

Science Denial and COVID Conspiracy TheoriesPotential Neurological Mechanisms and Possible Responses
Bruce L. Miller, MD
free access has active quiz
JAMA. 2020;324(22):2255-2256. doi:10.1001/jama.2020.21332
This Viewpoint discusses possible parallels between the distortion in sensory information and faulty monitoring of ideas characteristic of some patients with neurodegenerative diseases (dementia with Lewy bodies and Capgras syndrome, frontotemporal dementia) and the creation and maintenance of false conspiratorial beliefs about the COVID-19 pandemic in healthy populations that has hobbled an effective national response in the US.

Facing up to long COVID

The Lancet
Dec 12, 2020 Volume 396N umber 10266 p1861-1940
https://www.thelancet.com/journals/lancet/issue/current

 

Editorial
Facing up to long COVID
The Lancet
… Although vaccination has become the immediate focus of the pandemic response for many countries, patients with long COVID must not be forgotten or sidelined as countries begin to consider the end of the pandemic. Acknowledging the potential scale of the problem now and the complexities and variabilities of the disease course, and pressing for better research and care, could avoid years of struggle and mismanagement for patients with long COVID.

COVID vaccines: the world’s medical regulators need access to open data

Nature
Volume 588 Issue 7837, 10 December 2020
http://www.nature.com/nature/current_issue.html

 

Editorial | 08 December 2020
COVID vaccines: the world’s medical regulators need access to open data
The global race to produce COVID vaccines is a chance for regulators and drug companies to create a more harmonized approvals process.
The roll out of COVID-19 vaccines is under way, but without, it seems, much global coordination. China, Russia and the United Arab Emirates began administering vaccines before the conclusion of clinical trials. Last week, the United Kingdom issued emergency approval for a vaccine developed by the US biopharmaceutical company Pfizer and BioNTech of Mainz, Germany, following positive results from phase III testing. The US Food and Drug Administration (FDA) has needed longer to make its decision on the same vaccine. And the regulatory agencies of Australia, the European Union and Switzerland are taking longer still.

This patchwork of approvals processes, despite COVID-19 being a common enemy, has revived a long-standing question about how to accelerate harmonization in vaccine regulation. Researchers reviewing the regulatory landscape found at least 51 pathways to various types of accelerated vaccine approval in a group of 24 countries1.

Greater harmonization would bring many benefits. Drug companies could look forward to agreed definitions for different types of approval, and would benefit from agreed guidelines for criteria that their vaccine candidates would need to meet. If regulators were to ask for broadly the same things, companies could cut the time needed to prepare their drug applications. Companies, for their part, would need to allow — or help to create — a secure way for regulators to share data, which they are often not permitted to do at present.

By assessing the same data, regulators could more easily compare their findings and analyses with those of others, and their decisions would not only be more robust, but also be seen to be more robust. That, in turn, would shore up public confidence in a world in which vaccine hesitancy is rising and in which many citizens already have the means to compare regulatory verdicts. This would be an evolutionary shift, not a revolutionary one, because in recent years — and particularly since the 2014–16 Ebola crisis — regulators have made unprecedented efforts to discuss, coordinate and begin to harmonize some of their processes.

The FDA, which was set up in 1906, is the world’s oldest national medicines regulator. But the world has been moving towards greater regulatory coordination for some time. Europe’s regulatory system comprises a network of 50 national bodies from 31 European countries. The European Medicines Agency (EMA), created in 1995, sits at the centre of this network. All countries have their own medical regulators, but the EMA provides manufacturers with a single place for scientific evaluation of drug applications, if they want Europe-wide approval.

Although EMA and FDA verdicts are often broadly similar, the authorities differ in key ways. For example, the FDA requires drug companies to submit all the raw data from laboratory, animal and human trials so that it can do its own statistical analysis. By contrast, the EMA relies more on drug companies’ own analyses.

In other regions — Africa, for example — countries are also inching towards an approach that allows for the pooling of regulatory expertise. This is the purpose of the African Vaccine Regulatory Forum, set up in 2006.

And at the global level, in 2012, the member states of the World Health Organization (WHO) agreed to establish the International Coalition of Medicines Regulatory Authorities (ICMRA) to allow regulators to share information and agree on approaches. The ICMRA has 29 members, including regulators from China, Europe and the United States. Through it, members have been able to reach a consensus on the best animal models for testing COVID-19 vaccines, the ideal clinical-trial end points and the complicated issue of continuing placebo-controlled trials after vaccine roll out begins. The coalition’s COVID-19 working group is now trying to harmonize the monitoring of vaccines once they have been deployed, because faint signals of adverse effects might be too weak to spot in any one country.

And then there is the WHO itself. Low- and middle-income countries can now benefit from the work that goes into its Emergency Use Listing (EUL) process. On 13 November, the agency issued its first ever such vaccine listing, for a polio vaccine. National regulators still need to decide whether this vaccine is right for their country, but a recommendation from the WHO — and confidence in its assessment process — means that most are likely to follow its advice.

Around the end of October, the WHO requested that both the FDA and the EMA assess the suitability of COVID-19 vaccines for low- and middle-income countries as they consider whether to issue emergency authorizations. It is not clear whether the regulators will agree — but if either does, the WHO can draw on that analysis and issue its own EUL within days of the decision. That would be collaboration indeed.

These are all important and necessary efforts. The need now is to go one step further and find a path through the many different types of vaccine approval. Before the pandemic, the Coalition for Epidemic Preparedness Innovations, a global group of funding agencies, companies and non-governmental organizations, set up a working group to map out obstacles to better global regulatory alignment, in anticipation of a new infectious disease. This process confirmed how regulatory agencies differ on issues such as the use of genetic modification in vaccine development, clinical trials in pregnant women, and even vial labelling. But it also meant that inconsistencies were already mapped out and under discussion when the pandemic struck. COVID-19 has intensified these discussions.
The next step will not be easy. Regulators want to be able to exchange data. Their experiences during the pandemic have convinced many that they are moving towards a point at which this will be possible. They want to be able to talk to each other in the same units and about the same end points, and to make decisions based on the same data.

Ultimately, each country must make its own decisions about what’s best. But the goal of a harmonized regulatory dossier for vaccines, conforming to an agreed set of international regulatory requirements, would be transformative.

World View | 14 October 2020
Institutions can retool to make research more rigorous
Big moves to rebuild the scientific infrastructure are possible.
Ulrich Dirnagl

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

New England Journal of Medicine
December 10, 2020 Vol. 383 No. 24
http://www.nejm.org/toc/nejm/medical-journal

 

Original Article
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
December 10, 2020
DOI: 10.1056/NEJMoa2034577
Fernando P. Polack, M.D….Kathrin U. Jansen, Ph.D., and William C. Gruber, M.D. for the C4591001 Clinical Trial Group*
Abstract
Background
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently.
Methods
In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety.
Results
A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.
Conclusions
A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728. opens in new tab.)

Influenza vaccination hesitancy in five countries of South America. Confidence, complacency and convenience as determinants of immunization rates

PLoS One
http://www.plosone.org/

 

Research Article
Influenza vaccination hesitancy in five countries of South America. Confidence, complacency and convenience as determinants of immunization rates
Miguel Ángel González-Block, Emilio Gutiérrez-Calderón, Blanca Estela Pelcastre-Villafuerte, Juan Arroyo-Laguna, Yamila Comes, Pedro Crocco, Andréa Fachel-Leal, Laura Noboa, Daniela Riva-Knauth, Berenice Rodríguez-Zea, Mónica Ruoti, Elsa Sarti, Esteban Puentes-Rosas
Research Article | published 11 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0243833

Vaccines safety and maternal knowledge for enhanced maternal immunization acceptability in rural Uganda: A qualitative study approach

PLoS One
http://www.plosone.org/

 

Vaccines safety and maternal knowledge for enhanced maternal immunization acceptability in rural Uganda: A qualitative study approach
Dan Kajungu, Michael Muhoozi, James Stark, Daniel Weibel, Miriam C. J. M. Sturkenboom
Research Article | published 10 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0243834

Timeliness of immunisation with the pentavalent vaccine at different levels of the health care system in the Lao People’s Democratic Republic: A cross-sectional study

PLoS One
http://www.plosone.org/

 

Timeliness of immunisation with the pentavalent vaccine at different levels of the health care system in the Lao People’s Democratic Republic: A cross-sectional study
Lisa Hefele, Sengdavanh Syphan, Dalouny Xayavong, Anousin Homsana, Daria Kleine, Phetsavanh Chanthavilay, Phonethipsavanh Nouanthong, Kinnaly Xaydalasouk, Outavong Phathammavong, Somxay Billamay, Anonh Xeuatvongsa, Daniel Reinharz, Antony P. Black, Claude P. Muller
Research Article | published 08 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0242502

Hepatitis B Vaccination Uptake Rate and Predictors in Healthcare Professionals of Ethiopia

Risk Management and Healthcare Policy
https://www.dovepress.com/risk-management-and-healthcare-policy-archive56
[Accessed 12 Dec 2020]

 

Original Research
Hepatitis B Vaccination Uptake Rate and Predictors in Healthcare Professionals of Ethiopia
Getnet MA, Bayu NH, Abtew MD, W/Mariam TGM
Risk Management and Healthcare Policy 2020, 13:2875-2885
Published Date: 8 December 2020

China’s vaccine gambit

Science
11 December 2020 Vol 370, Issue 6522
http://www.sciencemag.org/current.dtl

 

Feature
China’s vaccine gambit
By Jon Cohen
Science11 Dec 2020 : 1263-1267 Full Access
With its global campaign to test and promote COVID-19 vaccines, China aims to win friends and cut deals.
Summary
On 29 February, less than 2 months after the world awakened to the threat of the pandemic coronavirus, virologist Chen Wei, a major general in China’s army, and six military scientists on her team received injections of an experimental COVID-19 vaccine. Chen, a national hero for her work on Ebola vaccines, had come to the initial center of the pandemic, Wuhan, with her group from the Academy of Medical Military Sciences, in part to help make the candidate vaccine with pharmaceutical company CanSino Biologics. In the United States, the Trump administration’s $10.8 billion Operation Warp Speed accelerated vaccine R&D faster than many researchers thought possible. But an equally massive effort has unfolded in China. CanSino and two other Chinese companies are investing substantial resources and testing four candidates in tens of thousands of volunteers around the world. They are likely only days or weeks away from announcing the outcomes of efficacy trials, just behind the encouraging early results recently announced by a brace of companies and institutions outside China.