Parent reported outcomes to measure satisfaction, acceptability, and daily life impact after vaccination with whole-cell and acellular pertussis vaccine in Chile

Vaccine
Volume 38, Issue 43 Pages 6659-6858 (7 October 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/43

 

Research article Abstract only
Parent reported outcomes to measure satisfaction, acceptability, and daily life impact after vaccination with whole-cell and acellular pertussis vaccine in Chile
Miguel O’Ryan, Arlene E. Calvo, Mónica Espinoza, Natalia Vega, … Denis Macina
Pages 6704-6713

Immunization stress-related responses presenting as psychogenic non-epileptic seizures following HPV vaccination in Rio Branco, Brazil

Vaccine
Volume 38, Issue 43 Pages 6659-6858 (7 October 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/43

 

Research article Abstract only
Immunization stress-related responses presenting as psychogenic non-epileptic seizures following HPV vaccination in Rio Branco, Brazil
Renato Luiz Marchetti, Jose Gallucci-Neto, Daniela Kurcgant, Inah Carolina Galatro Faria Proença, … Lucia Helena de Oliveira

County-level correlates of missed opportunities for HPV vaccination in Indiana: An environmental scan

Vaccine
Volume 38, Issue 43 Pages 6659-6858 (7 October 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/43

 

Research article Abstract only
County-level correlates of missed opportunities for HPV vaccination in Indiana: An environmental scan
Sharon C. Enujioke, Rivienne Shedd-Steele, Joanne Daggy, Heather Burney, … Gregory Zimet

Changes in parents’ decisions pertaining to vaccination of their children after the Changchun Changsheng vaccine scandal in Guangzhou, China

Vaccine
Volume 38, Issue 43 Pages 6659-6858 (7 October 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/43

 

Research article Abstract only
Changes in parents’ decisions pertaining to vaccination of their children after the Changchun Changsheng vaccine scandal in Guangzhou, China
Qing He, Hui Wang, Yu Ma, Zhiwei Wang, … Zhicong Yang

Knowledge and attitudes towards influenza and influenza vaccination among pregnant women in Kenya

Vaccine
Volume 38, Issue 43 Pages 6659-6858 (7 October 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/43

 

Research article Open access
Knowledge and attitudes towards influenza and influenza vaccination among pregnant women in Kenya
Nancy A. Otieno, Bryan Nyawanda, Fredrick Otiato, Maxwel Adero, … Sandra S. Chaves

Intussusception in children aged under two years in India: Retrospective surveillance at nineteen tertiary care hospitals

Vaccine
Volume 38, Issue 43 Pages 6659-6858 (7 October 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/43

 

Research article Open access
Intussusception in children aged under two years in India: Retrospective surveillance at nineteen tertiary care hospitals
Manoja Kumar Das, Narendra Kumar Arora, Bini Gupta, Apoorva Sharan, … Arindam Ray

Vaccinations and Chronic Diseases: Knowledge, Attitudes, and Self-Reported Adherence among Patients in Italy

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 26 Sep 2020)

 

Open Access Article
Vaccinations and Chronic Diseases: Knowledge, Attitudes, and Self-Reported Adherence among Patients in Italy
by Francesco Napolitano , Giorgia Della Polla , Maria Simona Capano , Michela Augimeri and Italo Francesco Angelillo
Vaccines 2020, 8(4), 560; https://doi.org/10.3390/vaccines8040560 – 25 Sep 2020
Viewed by 102
Abstract
The aims of this cross-sectional survey were to evaluate the knowledge, attitudes, and self-reported adherence to recommended vaccinations among a random sample of patients with chronic conditions presenting for a medical visit in out-patient clinics in Italy. Patients who were healthcare workers (HCWs), […

Impact of COVID-19 on Immunization Services for Maternal and Infant Vaccines: Results of a Survey Conducted by Imprint—The Immunising Pregnant Women and Infants Network

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 26 Sep 2020)

 

Open Access Article
Impact of COVID-19 on Immunization Services for Maternal and Infant Vaccines: Results of a Survey Conducted by Imprint—The Immunising Pregnant Women and Infants Network
by Anja Saso , Helen Skirrow and Beate Kampmann
Vaccines 2020, 8(3), 556; https://doi.org/10.3390/vaccines8030556 – 22 Sep 2020
Viewed by 370
Abstract
The COVID-19 pandemic response has caused disruption to healthcare services globally, including to routine immunizations. To understand immunization service interruptions specifically for maternal, neonatal and infant vaccines, we captured the local experiences of members of the Immunising Pregnant Women and Infants Network (IMPRINT) […]

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 26 Sep 2020
Health
Bill Gates: The Pandemic Has Erased Years of Progress
“If you only look at COVID deaths, you’re actually missing the scale of the setback.”
Ed Yong
September 23, 2020

Health
Fauci to a Meddling HHS Official: ‘Take a Hike’
The nation’s top public-health expert addresses political interference in the COVID-19 response, but urges Americans to focus on the winter ahead.
Alexis C. Madrigal
September 23, 2020

Paging Dr. Hamblin
Paging Dr. Hamblin: What If the Vaccine Works Only Half the Time?
A coronavirus vaccine doesn’t need to be perfect to still be valuable.
James Hamblin
September 23, 2020

 

BBC
http://www.bbc.co.uk/
Accessed 26 Sep 2020
Health
Coronavirus: UK pledges £500m to global vaccine-sharing scheme
Sep 26, 2020
The UK is to give £500m to a new global vaccine-sharing scheme designed to ensure treatments for Covid-19 are distributed fairly.
Prime Minister Boris Johnson made the announcement in a speech to the United Nations general assembly.
He called on world leaders to overcome their differences as he set out plans to prevent future global pandemics.
He also promised extra funding for the World Health Organization.

 

The Economist
http://www.economist.com/
Accessed 26 Sep 2020
[No new, unique, relevant content]

 

Financial Times
https://www.ft.com/
Accessed 26 Sep 2020
Opinion
Infecting UK volunteers with coronavirus requires maximum transparency
The editorial board
Volunteering to be infected with a virus that can be deadly and has no sure-fire cure takes a particular kind of courage. Yet in pursuit of an inoculation against coronavirus, the world’s first Covid-19 human challenge trials — with healthy patients being infected to assess the effectiveness of experimental vaccines — are set to be announced by the UK next week. If the ethical and technical issues can be addressed in time, trials will start in January at a quarantine facility in London.

Such trials, and the ethical dilemmas they present, are a global issue. Similar preparations are under way in the US, where the National Institutes of Health has awarded contracts to support the manufacturing of coronavirus strains suitable for challenge studies, and parts of Europe.

With further waves of coronavirus triggering renewed restrictions in countries such as Spain, France and the UK, and cases mushrooming in Latin America, India and elsewhere, vaccines still offer the best hope of deliverance. A fully effective treatment remains elusive, while the technology and capacity for mass, regular testing that could make it easier to live with the virus remain some way off.

Proponents of challenge trials argue they are the best way to narrow the large field of promising Covid-19 vaccine candidates that are likely to move into large-scale clinical testing next year. Ten vaccines are already in phase 3 trials, each requiring around 30,000 volunteers to be inoculated. Participants in those trials then go about their normal lives in the community and the researchers see how many develop Covid-19 — and how serious the symptoms are — compared with a control group who receive a placebo jab.

It will be hard to find enough volunteers and clinical resources to carry out conventional trials on that scale for the dozens of potential vaccines that will be ready for clinical testing in 2021. Challenge trials short-circuit the process. Volunteers receive the vaccine and about a month later a dose of coronavirus under controlled conditions, isolated in a quarantine facility where their health and immune responses are monitored carefully. Typically a participant would spend about a month in the clinic and (in the UK) receive a payment in the region of £4,000 to £5,000. Latest coronavirus news Follow FT’s live coverage and analysis of the global pandemic and the rapidly evolving economic crisis here.

Though challenge trials have been around for 200 years, what makes coronavirus different from most recent instances is the lack of a certain treatment for participants who fall ill. Subjects are likely to be young and low-risk. But each trial will need regulators and an independent ethics committee to be satisfied that consenting volunteers have been given all possible information on the risks. Regulators will need to ensure too that the virus strain is as mild as possible yet sufficient to provoke an immune response, doses given are as low as possible to achieve infection, and there is an established “rescue routine” for anyone who becomes sick. The UK trial will use the antiviral drug remdesivir.

Without infection challenge studies it may also be impossible to compare the efficacy of all Covid-19 vaccine candidates. Early successes should not crowd out vaccines that take longer to develop but work better or more safely.

Governments must ensure challenge trials are run with full transparency, so as not to undermine the (already fragile) public trust in Covid-19 vaccines. But conversely, if such trials can demonstrate some vaccines are effective while being carried out responsibly and ethically, they may help to reassure a nervous public and counter the efforts of anti-vaccine campaigners. The courageous volunteers will certainly deserve our gratitude.

 

Forbes
http://www.forbes.com/
Accessed 26 Sep 2020
Editors’ Pick  |
2 hours ago
Trump Administration Took $300 Million From CDC For Covid-19 Coronavirus Ad Campaign, Report Says
A “defeat despair” ad campaign reportedly will include celebrities like Dennis Quaid, Garth Brooks, and CeCe Winans.
By Bruce Y. Lee Senior Contributor

11 hours ago
Tuberculosis And Covid-19: Fighting A Deadly Syndemic
Together, Covid-19 and TB pose a deadly, dual threat – a syndemic that feeds on social inequities and poverty. Tremendous catch-up work, advocacy, and funding will be needed, to get back on track, even as the pandemic is pushing the world into the deepest recession since the second World War.
By Madhukar Pai Contributor

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 26 Sep 2020
[No new, unique, relevant content]

 

Foreign Policy
http://foreignpolicy.com/
Accessed 26 Sep 2020
Analysis |
Much Maligned But Still Necessary: the U.N. at 75
The postwar institution designed to maintain global peace has fallen short of many goals, but on the whole succeeded.
Michael Hirsh

The Big Think
The World Is Winning—and Losing—the Vaccine Race
Immunization to COVID-19 is supposed to solve our problems—but it’s starting to trigger even bigger ones.
By Adam Tooze
September 19, 2020, 6:00 AM

 

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

 

New Yorker
http://www.newyorker.com/
[No new, unique, relevant content]

 

New York Times
http://www.nytimes.com/
Accessed 26 Sep 2020
Asia Pacific
India’s Vaccine Industry Will ‘Help All Humanity,’ Modi Says
In a recorded address to the United Nations General Assembly, Prime Minister Narendra Modi of India said the country’s vaccine production and delivery capacity would help fight the coronavirus pandemic.
By The Associated Press

Business
China Gives Unproven Covid-19 Vaccines to Thousands, With Risks Unknown
Drug company workers, government officials and others have been injected outside the usual testing process. More will be soon, bewildering experts who worry about potential ill effects.
By Sui-Lee Wee

Politics
Cuomo to Form Task Force to Test Coronavirus Vaccine
Gov. Andrew M. Cuomo of New York said he planned to form a panel to advise the state on the coronavirus vaccine’s safety and effectiveness over concerns the federal approval process had become politicized.
By Office Of Gov. Andrew M. Cuomo
Sept. 23

Politics
Trump May Reject Tougher F.D.A. Vaccine Standards, Calling Them ‘Political’
In suggesting he might reject tougher guidelines, President Trump once again undermined efforts by government scientists to bolster public confidence in their work.
By Sheryl Gay Stolberg
Sept. 23

 

Washington Post
https://www.washingtonpost.com/
Accessed 26 Sep 2020
China aims to make 1 billion COVID-19 vaccine doses a year
BEIJING — A Chinese health official said Friday that the country’s annual production capacity for coronavirus vaccines will top 1 billion doses next year, following an aggressive government support program for construction of new factories.
Capacity is expected to reach 610 million doses by the end of this year, Zheng Zhongwei from the National Health Commission said.
“Next year, our annual capacity will reach more than 1 billion doses,” he said at a news conference.
American pharmaceutical giants Pfizer and Moderna aim to produce a billion doses each in 2021 as well…
· Sep 25, 2020

Think Tanks et al

Think Tanks et al
 
 
Brookings
http://www.brookings.edu/
Accessed 26 Sep 2020
[No new relevant content]
 
 
Center for Global Development [to 26 Sep 2020]
http://www.cgdev.org/page/press-center
Accessed 26 Sep 2020
[No new relevant content]
 
 
Chatham House [to 26 Sep 2020]
https://www.chathamhouse.org/
Webinar:
2020 US Elections – Healthcare During a Pandemic
30 September 2020 – 4:00pm to 4:45pm
(London, BST)
Register
Participants
:: Cheryl Cashin, Managing Director, Global Health Practice, Results for Development
:: Dr Abdul El-Sayed, Author, Healing Politics: A Doctor’s Journey Into the Heart of Our Political Epidemic (2020)
:: Chair: Robert Yates, Head, Centre on Global Health Security, Chatham House

 
 
CSIS
https://www.csis.org/
Accessed 26 Sep 2020
[No new relevant content]

 
 
Council on Foreign Relations
http://www.cfr.org/
Accessed 26 Sep 2020
[No new relevant content]
 
 
Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 26 Sep 2020
[No new relevant content]

Vaccines and Global Health: The Week in Review :: 19 September 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

A World in Disorder. Global Preparedness Monitoring Board – Annual Report 2020

Milestones :: Perspectives :: Research

 

A World in Disorder. Global Preparedness Monitoring Board – Annual Report 2020
World Health Organization 2020 :: 52 pages
FOREWARD
Never before has the world been so clearly forewarned of the dangers of a devastating pandemic, nor previously had the knowledge, resources and technologies to deal with such a threat. Yet, never before has the world witnessed a pandemic of such widespread and destructive social and economic impact.

The COVID-19 pandemic has revealed a collective failure to take pandemic prevention, preparedness and response seriously and prioritize it accordingly. It has demonstrated the fragility of highly interconnected economies and social systems, and the fragility of trust. It has exploited and exacerbated the fissures within societies and among nations. It has exploited inequalities, reminding us in no uncertain terms that there is no health security without social security. COVID-19 has taken advantage of a world in disorder…

…In issuing its warning in last year’s inaugural report, the GPMB stressed the inadequacy of systems and financing required to detect and respond to health emergencies. As COVID-19 has proven, these systems remain dangerously deficient and under-resourced. This pandemic has also called out the human dimensions of health security, the actions of leaders and citizens that are so critical to vigorous preparedness and response.
Our report this year highlights responsible leadership and citizenship, as well as the adequacy of systems and resources, as key factors for success. It puts a special emphasis on the factor that binds these four elements together into an effective whole: the principles and values of governance that ensure the right choices, decisions and actions are taken at the right time. It points out that none are safe until all are safe and calls for a renewed commitment to multilateralism and to WHO and the multilateral system…

…The pandemic is far from over. Some countries have been relatively successful in suppressing the virus, protecting their populations, saving millions of lives. Others have not. Close to a million lives have been lost to COVID-19. The devastating economic and societal impact of COVID-19 reminds us, yet again, of the centrality of investment in pandemic preparedness to human security, and the need to reconsider how national security budgets are spent.
We have already learned many crucial lessons that demand immediate action if we are to say with any confidence, “never again”. But learning without action is pointless, and unsustained commitment is futile. As we warned in our last report, “For too long, we have allowed a cycle of panic and neglect when it comes to pandemics: we ramp up efforts when there is a serious threat, then quickly forget about them when the threat subsides.”
Again, we say: “It is well past time to act.” And we identify the commitments and actions leaders and citizens must take – boldly, decisively, immediately, and with new energy animated by the grim recognition that inaction kills.

H.E. Gro Harlem Brundtland
Co-Chair, Former Prime Minister, Norway, and Former Director- General, World Health
Organization
Mr Elhadj As Sy
Co-Chair, Chair, Kofi Annan Foundation Board, and Former Secretary-General, International
Federation of Red Cross and Red Crescent Societies

 

EXECUTIVE SUMMARY
In our 2019 Annual Report, ‘A World at Risk’, we warned of the very real threat of ‘a rapidly spreading pandemic due to a lethal respiratory pathogen’2, and the need for determined political leadership at national and global levels. We called for seven urgent actions to prepare the world for health emergencies:
Heads of government must commit and invest
Countries and regional organizations must lead by example
All countries must build strong systems
Countries, donors and multilateral institutions must be prepared for the worst
Financing institutions must link preparedness with financial risk planning
Development assistance funders must create incentives and increase funding for preparedness
The United Nations must strengthen coordination mechanisms

 

Progress in implementing these actions has been limited. It is not as if the world has lacked the opportunity to take these steps. There have been numerous calls for action in these areas over the last decade, yet none have generated the changes needed. Financial and political investments in preparedness have been insufficient, and we are all paying the price.

Conclusion & commitment
The COVID-19 pandemic is providing a harsh test of the world’s preparedness. The Board concludes that little progress has been made on any of the actions called for in last year’s report and that this lack of leadership is exacerbating the pandemic. Failure to learn the lessons of COVID-19 or to act on them with the necessary resources and commitment will mean that the next pandemic, which is sure to come, will be even more damaging.

We recognize that the GPMB must also change. Our monitoring and advocacy for preparedness must better reflect the contribution of sectors other than health, the importance of social protection, and be based on improved and predictive measures of preparedness.

 

GPMB Commitment
As the Global Preparedness Monitoring Board, we pledge to support good governance of global health security by fulfilling our mandate to independently monitor preparedness across all sectors and stakeholders, report regularly on progress, and continuously advocate for effective action.

WHO – Review Committee on the Functioning of the International Health Regulations (2005) during the COVID-19 Response

Milestones :: Perspectives :: Research

 

WHO – Review Committee on the Functioning of the International Health Regulations (2005) during the COVID-19 Response
The Committee begins its work on 8 and 9 September 2020 and will meet regularly and report on its progress, through the Director-General, to WHO Governing Bodies.

World Health Assembly resolution WHA73.1 requested the WHO Director-General, inter alia, to initiate a stepwise process of impartial, independent and comprehensive evaluation of the WHO-coordinated international health response to COVID-19, including by using existing mechanisms such as the Review Committee under the International Health Regulations (2005) (IHR).

In line with the resolution, the WHO Director-General has convened a Review Committee under the IHR:
[1] to review the functioning of the IHR during the COVID-19 response; and
[2] the status of implementation of the relevant recommendations of previous IHR Review Committees.

 

Members
Dr Preben Aavitsland
Senior Consultant, Professor, Domain for infectious disease prevention, health and the
environment, Norwegian Institute of Public Health, Oslo, Norway
Dr Ximena Aguilera
Director, Center of Epidemiology and Health Policy, Faculty of Medicine, Universidad del
Desarrollo, Santiago, Chile
Dr Yasir Ibrahim Ahmed
Medical Director and Senior Consultant, Medical Hospital, Maldives
Dr Seif Salam Al-Abri
Director General for Disease Surveillance and Control at the Ministry of Health of Oman
Colonel (retired) Vincent Anami
Continent Representative (Africa), Center for Disaster and Humanitarian Assistance Medicine,
Uniformed Services University of the Health and Sciences, Friends International Centre,
Nairobi, Kenya
Dr Thouraya Annabi Attia
Former Director of Health Protection and Control, National Agency of Health Protection, Ministry of Health, Tunisia
Dr Carmen Aramburu
Director of Health and Social Policy, Delegation of the Spanish Government in Catalonia,
Spain
Dr Kalpana Baruah
Joint Director, National Vector Borne Disease Control Programme, Ministry of Health and
Family Welfare, New Delhi, India
Professor Lucille Blumberg
Deputy Director, National Institute for Communicable Diseases, National Health Laboratory
Service, Johannesburg, South Africa
Ms Malinee Chittaganpitch
Medical Scientist Advisor, Department of Medical Sciences, MoPH Thailand
Mr John Lavery
Executive Director, Health Emergency Management British Columbia, Provincial Health
Services Authority, Canada
Professor James LeDuc
Director of Galveston National Laboratory, University of Texas Medical Branch, Galveston,
United States of America
Dr Dexin Li
Former Director, National Institute for Viral Diseases Control and Prevention, Chinese Center
for Disease Control and Prevention, People’s Republic of China
Dr Rinat Maksyutov
Director General, Federal Budgetary Research Institution – State Research Center of Virology
and Biotechnology VECTOR, Federal Service for Surveillance on Consumer Rights Protection
and Human Well-being, Koltsovo, Russian Federation
Dr Talat Mokhtari Azad
Director, Iranian National Influenza Center, Department, Tehran University of Medical
Sciences, School of Public Health, Tehran, Islamic Republic of Iran
Dr Mohamed Moussif
Chief of Public Health, Mohammad V International Airport, and National Coordinator of the
Points of Entry Program, Morocco
Ms Olubunmi Ojo
Former Director, Disease Surveillance, Nigeria Centre for Disease Control, Abuja, Nigeria
Dr Jean-Marie Okwo-Bele
Public health consultant, Democratic Republic of the Congo
Dr Tomoya Saito
Director, Department of Health Crisis Management, National Institute of Public Health of
Japan
Dr Amadou Alpha Sall
Director, Institut Pasteur de Dakar and WHO Collaborating Center for Arboviruses and Viral Hemorrhagic Fevers, Senegal
Dr Mark Salter
Consultant in Global Health, Public Health England, London, United Kingdom of Great Britain and Northern Ireland
Professor Myongsei Sohn
Professor Emeritus, College of Medicine, Yonsei University, Republic of Korea
Professor Lothar H. Wieler
President of the Robert Koch Institute, Germany
Biographies 
International Health Regulations (IHR) Secretariat

COVID-19: G20 Health Ministers

Milestones :: Perspectives :: Research

 

COVID-19: G20 Health Ministers

Joint Statement – G20 Joint Finance & Health Ministers Meeting
17 September 2020
Our urgent collective priority is to overcome the COVID-19 pandemic and alleviate its health, social and economic impacts. We continue to act upon our Leaders’ commitments made at their extraordinary summit on 26 March 2020, and the progress achieved since. We will continue to use all available policy tools to safeguard people’s lives, jobs and incomes, support the global economic recovery, and enhance the resilience of health and financial systems, while safeguarding against downside risks.

We recognize the positive impact of investment in health system strengthening on economic resilience and growth, both in overcoming the current crisis and in the long term. We remain committed to investing in an effective response to the COVID-19 pandemic to bring the spread of the virus under control and prevent further transmission; thereby minimizing the economic and social disruption while reinforcing our support for returning to strong, sustainable, balanced, and inclusive growth.

We have mobilized resources to address the financing needs in global health to support the fight against the COVID-19 pandemic, and encourage joint efforts including further voluntary contributions to relevant initiatives, organizations and financing platforms. We emphasize the need for a global response and the importance of taking forward our collective action to accelerate the research, development, manufacturing and distribution of COVID-19 diagnostics, therapeutics and vaccines, including through the Access to COVID-19 Tools Accelerator (ACT-A) initiative and its COVAX facility and voluntary licensing of intellectual property, with the aim of supporting equitable and affordable access for all, which is key to overcoming the pandemic and supporting global economic recovery. We note that further actions are needed to address the financing needs. We ask Multilateral Development Banks (MDBs) to swiftly consider ways to strengthen the financial support for countries’ access to COVID-19 tools. We recognize the role of extensive immunization against COVID-19 as a global public good for health in preventing, containing, and stopping transmission.

We continue to take collective action as a part of the G20 Action Plan – Supporting the Global Economy through the COVID-19 Pandemic. We reiterate our commitment to respond promptly to the evolving health and socio-economic situations and drive forward international economic cooperation as we navigate this crisis and look ahead to a strong, sustainable, balanced and inclusive global economic recovery. We will reflect the outcomes of today’s meeting in the updated G20 Action Plan that will be presented at the G20 Finance Ministers and Central Bank Governors’ meeting in October 2020 and to the G20 Leaders’ Summit in November 2020. We call on International Organizations (IOs), notably the IMF and OECD, to continue to integrate available pandemic data in elaborating different scenarios as for the economic impact of the health crisis going forward.

We take note of the assessment of gaps in pandemic preparedness that the World Health Organization (WHO) undertook in cooperation with relevant international organizations as requested by G20 Leaders in March 2020. We look forward to the work of the Independent Panel for Pandemic Preparedness and Response (IPPR) on evaluating the global health response to the COVID-19 pandemic as outlined in the World Health Assembly (WHA) Resolution on COVID-19. We acknowledge the important role of the United Nations’ system and agencies, including the WHO, while considering the ongoing evaluations and the need to strengthen its overall effectiveness, in coordinating and supporting the global response to the COVID-19 pandemic and the central efforts of Member States therein, as outlined in the World Health Assembly (WHA) Resolution on COVID-19. We recognize that the COVID-19 pandemic has highlighted the need to strengthen health systems and has shown vulnerabilities in the international community’s ability to prevent, detect and respond effectively to pandemic threats. This reinforces the need to deliver on commitments to strengthen health systems, particularly enhancing preparedness, prevention, detection and response capacities.

We will intensify our efforts to support pandemic surveillance and epidemic intelligence, strengthen health system capabilities, and support platforms to accelerate research and development, to proactively identify and address new and reemerging infectious pathogens. We reaffirm our commitment to full compliance with the International Health Regulations (IHR 2005), to improve their implementation and to the continued sharing of timely, transparent and standardized data and information including on health measures and the effectiveness of non-pharmaceutical interventions. We encourage innovative ways of capturing and sharing user- and decision-friendly information.

We re-emphasize the importance of well-functioning, value-based, inclusive and resilient health systems that can sustain equitable and affordable access to essential and quality health services for all, especially for the poorest and most vulnerable. We reemphasize our commitment to the G20 Shared Understanding on the Importance of Universal Health Coverage (UHC) Financing in Developing Countries to improve the resilience, prevention, detection, preparedness and response of health systems through protecting and investing in public health. We recall our commitment to move towards achieving UHC and the important role of countries’ following their own paths in line with national contexts and priorities to UHC. We will continue to address the disproportionate economic and social impact of the crisis on women, young people, and the most vulnerable segments of society.

Although current measures are critical, major gaps still exist in global pandemic preparedness and response. Therefore, we will work together to lay the foundation for targeted actions to help respond to the most immediate challenges posed by the COVID-19 pandemic and ensure that the world is better prepared to curb the impact of future health-related crises in line with One Health Approach. This includes delivering on previous G20 commitments to tackle antimicrobial resistance. We will integrate the economic risks of pandemics, drug resistant infectious diseases, non-communicable diseases and high-impact tail risks more systematically into the G20’s global risk monitoring and preparedness. We will, with the support of relevant IOs, build on key findings, lessons learned and propose recommendations to address existing gaps in global pandemic preparedness and response ahead of the G20 Leaders’ Summit in November 2020.

 

::::::

Wellcome Trust statements on novel coronavirus (Covid-19)
Press release | 17 September 2020
In reaction to G20 Joint Finance & Health Ministers Meeting joint statement [PDF],
Dr Jeremy Farrar, Director of Wellcome, said:

“It is encouraging to hear the G20 Finance and Health Ministers remain committed to investing in an effective response to the Covid-19 pandemic. But we’re running out of time and these warm words must urgently turn into the real investment and global leadership that is needed.
“The ACT-Accelerator urgently needs $35bn to develop and provide tests, treatments and vaccines for the world and to have the health systems to deliver them. So far, less than 10% of this been raised. $35bn is a tiny figure when compared to the trillions the world economy has already lost and will continue to lose as this pandemic continues to reverberate around the world.

“Securing this funding now will prove to be the wisest investment humanity has ever made. Putting it off will only prolong the pandemic and all its dreadful consequences. The actions leaders take today will affect how the world spends the next decade. This needs a moment of historic political and financial leadership.  Leadership that will change the world.  Leadership that will be remembered in a 100 years’ time. But we need it now through actions not words.”

 

::::::

IFPMA Statement to G20 Health and Finance Ministers
17 September 2020
Geneva: Now more than ever, the adage “Health is Wealth” has heightened significance, with the COVID-19 pandemic highlighting the delicate and essential interdependence between public health and economic prosperity. The biopharmaceutical industry is working alongside governments worldwide to combat the burden of this unprecedented crisis, recognizing that unparalleled collaboration among all sectors of society is the only way to meet this challenge.

The stewardship of G20 Leaders is key to this coordinated global response, with a view to adopting policies that address the significant, intertwined impacts of the current pandemic while fostering preparedness to face similar threats in the future, as well as safeguarding resources for important healthcare needs beyond COVID-19. As the G20 Health and Finance Ministers meet on 17 September, we must be reminded that overcoming a global pandemic of this proportion rests on global solidarity, and a collective responsibility that calls for highly coordinated and collaborative action by public and private actors alike.

Since the start of the crisis, biopharmaceutical companies have shown their commitment to uniting in purpose by working together and to using their resources, technologies and know-how to develop medicines and vaccines. Beyond the discovery stage, industry has reiterated the importance of ensuring that these medicines and vaccines become accessible and affordable to all those who need them.

During this crisis, biopharmaceutical companies are:
Investing their scientific expertise and creating and leveraging cutting edge technologies to speed the development of safe and effective medicines and vaccines;
Conducting clinical trials to test new and existing therapies for their use in the treatment of COVID-19;
Expanding the private sector’s unique manufacturing capabilities in an unprecedented way to respond to this crisis and making at-risk investments today to scale-up manufacturing capacity in order to provide worldwide supply as quickly as possible once successful medicines and vaccines are developed;
Collaborating with government agencies, hospitals, doctors and others to donate supplies and medicines to help those affected around the world;
Working with governments, manufacturers, and payers to ensure that when new medicines and vaccines are approved, they will be available and affordable for everybody who needs them;
Ensuring that medicines and vaccines are made accessible to patients around the world by using differential pricing to account for each country’s social and economic capacities, while complying with antitrust regulations by keeping pricing policies and approaches confidential;
Implementing strong contingency plans to ensure continuity of supply chains for medicines and other health products needed to respond to COVID-19;
Upholding the highest standards of ethics and business integrity to improve patient care; and,
Continuing to support the broader healthcare ecosystem and infrastructure to ensure resilience, efficiency, and sustainability of healthcare systems.

 

As we come together in solidarity across the public and private sector, we call on the G20 to:
Support partnerships among industry, governments, civil society, international organizations, and academia to leverage the expertise and strength of each sector to respond to the COVID-19 pandemic.
View private sector as an ally and solutions partner and commit to not adopt policies and decisions that could restrict access for those in need, such as national stockpiling, or ultimately hamper innovation and research and development.
Strengthen dialogue among industry, governments, citizens, and regional and international procurement agencies to safeguard the continuity of immunization services during the COVID-19 pandemic and prevent the resurgence of outbreak-prone vaccine-preventable diseases such as measles.
Refrain from constraining prevention budgets for communicable and non-communicable diseases and enhance the resilience of health systems in the COVID-19 recovery phase with longer-term investment in preventative interventions across the life-course.
Refrain from imposing trade or other policy restrictions, and work in concert in a spirit of solidarity to minimize trade disruption in medicines, vaccines, and their component parts, essential medical products, data and other goods or services needed to respond to this crisis.
Encourage national regulatory agency collaboration and use of reliance approaches and regulatory agility for an effective and efficient response to COVID-19, as well as for the continued research, development and supply of essential medicines and vaccines.
Ensure the highest standards of ethics and business integrity are preserved throughout and following the crisis in close coordination with the entire biopharmaceutical industry as well as the broader G20 business community, including in such areas as procurement, customs, and donations.
Identify ways to work with the broader healthcare ecosystem and infrastructure to ensure resilience, efficiency, coordination, and sustainability of healthcare systems, so that scarce resources can continue to be allocated to what most matters to patients and society in a manner which maintains and builds public trust and confidence in healthcare systems.
Continue to foster a policy environment which promotes research and development and effective intellectual property protection, gives impetus to innovations and advances in health, as well as incentivizes stakeholders to undertake risky investments into the discovery of new products.
Recognize that intellectual property has enabled several medicines and vaccines currently being tested for additional use in the fight against the COVID-19 virus and has not been an impediment to the common goal of ending this pandemic.
In view of other emerging global health threats, publish national roadmaps for the development and implementation of new economic incentives and market reforms for antibiotics over the next five years and report progress annually at G20 summits, to attract sustainable and robust investment into AMR R&D. These reforms need to properly reflect the full benefits these medicines bring to the world at large and ensure society has access to treatments for accelerating bacterial resistance.

While our focus is on COVID-19 today, the biopharmaceutical industry looks to the G20 to pave the way to a future where health systems are resilient; where partnership across public and private actors is leveraged to highlight the expertise of each sector; and where investment in health is recognized as an essential component of the sustainability of economies and societies.

Gates Foundation’s Annual Goalkeepers Report Shows COVID-19 Has Stalled 20 Years of Progress, Calls for Global Response to End the Pandemic

Milestones :: Perspectives :: Research

 

Gates Foundation’s Annual Goalkeepers Report Shows COVID-19 Has Stalled 20 Years of Progress, Calls for Global Response to End the Pandemic
Report shows how economic damage has reinforced inequities and derailed achievement of the UN Sustainable Development Goals; spotlights countries innovating to meet challenges

SEATTLE, SEPTEMBER 14, 2020 – The Bill & Melinda Gates Foundation today launched its fourth annual Goalkeepers Report, featuring new data showing how the ripple effects of COVID-19 have stopped 20 years of progress toward the United Nations Sustainable Development Goals (Global Goals).

 

The report provides the most current global dataset for how the pandemic is affecting progress toward the Global Goals. It shows that by nearly every indicator, the world has regressed. Because of COVID-19, extreme poverty has increased by 7%. Vaccine coverage, a good proxy measure for how health systems are functioning, is dropping to levels last seen in the 1990s, setting the world back about 25 years in 25 weeks.

Economic damage from COVID-19 is reinforcing inequalities. The pandemic has had a disproportionate impact on women, racial and ethnic minority communities, and people living in extreme poverty. Around the world, women are facing an increased burden from rising demands in total unpaid care work and experiencing the majority of job losses. In the United States, the percentage of Black and Latinx people who say they cannot pay their rent is twice the percentage of white people.

Despite the bleak projections, Bill and Melinda Gates describe a path to ending the pandemic and resuming progress toward the Global Goals. In the report, which they co-author every year, they call on the world to collaborate on the development of diagnostics, vaccines, and treatment; manufacture tests and doses as quickly as possible; and deliver these tools equitably based on need rather than the ability to pay. There are currently several viable strategies to help achieve an equitable outcome, including the Access to COVID-19 Tools (ACT) Accelerator, the most serious collaborative effort to end the pandemic, which brings together proven organizations like Gavi, the Vaccine Alliance and the Global Fund to Fight AIDS, Tuberculosis and Malaria.

“The response to the COVID-19 pandemic has shown us some of the best of humanity: pathbreaking innovation, heroic acts by frontline workers, and ordinary people doing the best they can for their families, neighbors, and communities,” Bill and Melinda Gates write. “This is a shared global crisis that demands a shared global response.”…

COVID-19 Vaccines: Development, Diplomacy

Milestones :: Perspectives :: Research

 

COVID-19 Vaccines: Development, Diplomacy

 

Editor’s Note:
We very selectively include content from general media in this section, primarily when it provides critical information not captured elsewhere, as below.

China and Russia are ahead in the global coronavirus vaccine race, bending long-standing rules as they go

Screen Shot 2020-09-20 at 9.43.23 PM

By Eva Dou and Isabelle Khurshudyan
The Washington Post
September 18, 2020 at 2:07 p.m. EDT

SEOUL — China and Russia have begun a mass rollout of their coronavirus vaccines before clinical tests are complete, in what is emerging as an unexpectedly complex geopolitical challenge for the United States.

China’s Sinopharm announced this week that it would provide emergency doses of one of its two trial vaccines to the United Arab Emirates, prioritizing the U.S. ally over the vast majority of Chinese. China is now the sole supplier of coronavirus vaccine to the Middle East.

Meanwhile, Russia’s sovereign wealth fund signed a deal this week to supply India with 100 million doses of the Sputnik V vaccine.

These moves have thrown Western policymakers off balance. American health-care experts say the United States should not rush out its own vaccine in response. But that leaves China and Russia as the only countries wielding this valuable diplomatic tool for potentially months to come.

The upshot is that by next year, China and Russia may have purchased significant geopolitical power by having bent the rules and rushed out their vaccines. It is also possible their vaccines may fail, at enormous human cost.

“It’s really insane and a terrible idea,” Arthur Caplan, head of the division of medical ethics at New York University’s Grossman School of Medicine, said of China and Russia not waiting for the results of Phase 3 trials. “It’s staggeringly hard to comprehend.”

Kirill Dmitriev, head of the Russian Direct Investment Fund, which bankrolled Russia’s vaccine efforts, said Russia’s decision to roll out Sputnik V before the completion of Phase 3 trials has been validated by other countries now doing the same.

“The criticism was that you cannot register a vaccine before Phase 3,” Dmitriev said. “But after this, China registered a vaccine, the UAE registered a vaccine before completion of Phase 3, and both Britain and the U.S. said publicly they’re considering registering a vaccine before Phase 3. So this part of the criticism is gone.”

In recent days, President Trump has pressed for faster release of an American vaccine, while U.S. pharmaceutical companies have resisted the idea of taking a shortcut around long-established safety protocols.

Hundreds of thousands of people in China, including diplomats, the military, front-line health workers and employees of state-owned enterprises, have received Sinopharm’s vaccines under urgent-use stipulations, according to state media reports last week. But even as the rest of the country awaits access, Beijing has begun deploying vaccines abroad to regions where it is seeking to expand its influence.

Aside from the UAE collaboration, Sinopharm is also running Phase 3 trials in Jordan and Bahrain.

Egypt announced on Sept. 11 that it will also begin trials with Sinopharm, three days after the British-Swedish drugmaker AstraZeneca paused its clinical trial because of a “potentially unexplained illness.” The trial has since resumed, although not in the United States. Egypt signed a deal with AstraZeneca in July to purchase 30 million doses of its vaccine.
Caplan said of these geopolitical dynamics: “Yeah, it’s a problem.”

Officials in Moscow said this week that initial doses of the Sputnik V vaccine have been delivered to all regions of Russia, with health-care workers and teachers the first to receive access.

India, Brazil, Mexico and Kazakhstan have agreed to purchase Sputnik V.

For China, the moves represent an enormous gamble. As the country where the novel coronavirus originated, it has sought to make amends and blunt international fury. But some of its earlier efforts ended up backfiring, such as when batches of masks and other personal protective equipment exported from China were found to be defective.

The stakes are far higher with vaccines. Physicians say there is a risk of rare but severe side effects that do not present in small-scale trials, which is why large-scale Phase 3 trials are usually conducted for months before a vaccine is approved for sale. Safety issues could also emerge because of rushed manufacturing.

But if China’s bet pays off — if its vaccines prove to be safe and effective — it could cement its lead over the West in economic recovery in 2021, while also using the vaccine as a powerful diplomatic tool.

 

Picking winners
Even as China and Russia speed ahead with vaccine deployment, there will not be enough doses for everyone, necessitating decisions about who gets priority. Both countries estimate they can produce enough vaccine in the first year for a fraction of their populations.

Last week, Zhou Song, a Sinopharm executive, told state radio that the company expected an initial output of 300 million doses a year. At two doses per person, that would cover a tenth of China’s population. The vaccines will be more broadly available in December, he said.

China has a total of four vaccine candidates in Phase 3 testing, and their makers have scattered across the world to run trials. Executives have explained that China has so few coronavirus cases that it is hard to run the trials at home.

But this overseas testing has also been diplomatically expedient for Beijing, as it is essentially an early-access pass to vaccines that China can offer developing nations. Countries that have signed up to run Phase 3 trials of Chinese coronavirus vaccines include Argentina, Bahrain, Brazil, Bangladesh, Egypt, Indonesia, Jordan, Morocco, Peru, Russia, Saudi Arabia and the UAE.
The Russian Direct Investment Fund said it expects to have 30 million doses produced in Russia by the end of the year — enough for roughly 20 percent of the population.

But while the domestically produced doses of Sputnik V will be reserved for Russians, the investment fund plans to manufacture larger quantities of the vaccine abroad for international sale.

Russian Health Minister Mikhail Murashko told the state-run Tass news agency this week that of the announced 40,000 volunteers for Phase 3 trials, more than 300 had been vaccinated so far. That does not include the health-care workers or teachers who volunteered for vaccination, and it was unclear how many have done so.

Murashko added that the vaccine will be more widely available to the general population in late November or December. Russia’s Health Ministry did not respond to a request for comment.

 

::::::

State News Announcement
Rapid progress made in developing vaccine – China
Updated: 2020-09-17 China Daily Global
Expert says it may be available for public use as early as November
Research and development on COVID-19 vaccines in China is progressing rapidly, and they may be available for public use as early as November, a senior virologist said.

Five of the nine COVID-19 vaccines that have entered phase 3 clinical trials globally are being developed in China, and they have produced satisfying trial results, said Wu Guizhen, chief biosafety expert at the Chinese Center for Disease Control and Prevention. A vaccine usually has to complete three phases of trials before gaining market approval.

None of the people who have received candidate COVID-19 vaccines developed by China for emergency use have exhibited serious side effects or contracted the novel coronavirus, Wu said.

“It is expected that ordinary people can receive COVID-19 vaccination in November or December,” she said. “We expect the vaccinations will remain effective for between one and three years.”…

 

::::::

Media Release
RDIF and Dr. Reddy’s to cooperate on clinical trials and supply of 100 million doses of Sputnik V vaccine to India
Sep 16, 2020 MOSCOW and HYDERABAD, India, Sept. 16, 2020 /PRNewswire/ — The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s), a global pharmaceutical company headquartered out of India, have agreed to cooperate on clinical trials and distribution of Sputnik V vaccine in India.

Upon regulatory approval in India, RDIF shall supply to Dr. Reddy’s 100 million doses of the vaccine. The Sputnik V vaccine, which is based on well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.

The agreement between RDIF and Dr Reddy’s reflects the growing awareness of countries and organizations to have a diversified anti-COVID vaccine portfolio to protect their populations.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said: “We are very pleased to partner with Dr.Reddy’s in India. Dr. Reddy’s has had a very well established and respected presence in Russia for over 25 years and is one of the leading pharmaceutical companies in India. India is amongst most severely impacted countries from COVID 19 and we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to India in the battle against COVID 19.

RDIF partners will receive an effective and safe drug to fight the coronavirus. The platform of human adenoviral vectors, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and it has been found safe with no potential negative long-term consequences.”

 

GV Prasad, Co-Chairman of Dr. Reddy’s Laboratories stated: “We are pleased to partner with RDIF to bring the vaccine to India. The Phase I and II results have shown promise, and we will be conducting Phase-III trials in India to meet the requirements of the Indian regulators. Sputnik V vaccine could provide a credible option in our fight against COVID 19 in India.”…

Advancing COVID-19 vaccines – avoiding different regulatory standards for different vaccines and need for open and transparent data sharing

Featured Journal Content

International Journal of Infectious Diseases
September 2020 Volume 98, p1-502
https://www.ijidonline.com/issue/S1201-9712(20)X0010-5
Coronavirus (COVID-19) Collection
Advancing COVID-19 vaccines – avoiding different regulatory standards for different vaccines and need for open and transparent data sharing
Eskild Petersen, Christian Wejse, Alimuddin Zumla
p501–502
Published online: August 18, 2020
Introduction
The erratic ways by which the global scientific R&D, pharma and technology community conducted themselves during epidemics such as SARS-CoV-1, Ebola virus, MERS-CoV and others, the lack of co-operation and missed opportunities for filling important knowledge gaps and having an enhancing and multiplier effect, led to the establishment of the WHO R&D Blueprint and global strategy and preparedness plan (WHO, 2020a). The Blueprint leverages the successes and addresses the gaps in order for the world to be prepared for the next pandemic(s). Previous attempts to develop a vaccine against two lethal coronaviruses, SARS-COV-1 and MERS-COV, generated knowledge about their structure, function and pathogenesis (
Prompetchara et al., 2020, Dhama et al., 2020), although several vaccine candidates for SARS-COV-1 and MERS-CoV failed in early-stage clinical trials, and none were advanced to licensing. However, the experience accelerated rapid development of several technological platforms which are now being used for development of COVID-19 vaccines. The explosive global spread of COVID-19 pandemic has generated international consensus in principle, between the WHO, vaccine developers, governments, funders, donors and industry, with agreement on the need to develop an effective COVID vaccine and plans for fair and equitable rollout to all countries (Lurie et al., 2020. Important concerns during these discussions have been expressed by developing countries that only developed countries will have priority access to any new COVID 19 vaccine

COVID-19 Vaccines: Allocation

Featured Journal Content

Editor’s Note:
We have not encountered any update on country pledges to the COVAX facility as of yesterday, 18 September.

COVAX: A Moment of Truth in the Pandemic
18 Sep 2020
By Richard Hatchett (CEO, CEPI), Seth Berkley (CEO, Gavi, the Vaccine Alliance), Soumya Swaminathan (Chief Scientist, WHO)
This article originally appeared on Project Syndicate on 16 Sep 2020.

As the most ambitious pandemic-response initiative ever conceived, the COVID-19 Vaccine Global Access Facility is the best chance the world has to bring the pandemic to an end. But to succeed, COVAX requires broad international buy-in, based on the recognition that no one is safe until everyone is.

Now almost in its tenth month, the COVID-19 pandemic is still wreaking havoc on economies and lives around the world. But while the end of the crisis seems as far away as ever, the fact is that we are approaching a potential turning point. World leaders now have an opportunity to seal the deal on a global framework that puts international cooperation above vaccine nationalism in stopping the pandemic.

The moment of truth will be at midnight on September 18. That is the deadline for countries to join the COVID-19 Vaccine Global Access Facility (COVAX), an initiative launched by Gavi, the Vaccine Alliance, the World Health Organization, and the Coalition for Epidemic Preparedness Innovations. COVAX represents the best chance we have to provide people in all countries with rapid, fair, and equitable access to COVID-19 vaccines as soon as they become available. The initiative has already achieved an extraordinary scale, with more than 170 countries (representing 70% of the global population) already signaling their intent to join. At a time when most countries are undergoing unprecedented crises, governments are eager for solutions that will benefit everyone.

Nothing like COVAX has ever been attempted, and the short timeframe in which it has been assembled makes it all the more remarkable. If successful, this will be the first time that the international community has come together to ensure equitable and simultaneous access to new lifesaving pandemic interventions for rich and poor alike.

As we head into the fall, and COVID-19 continues to spread, the global death toll is approaching one million, with monthly economic losses estimated at $500 billion. Under these conditions, ensuring fair, universal access to vaccines is not only the right thing to do. It is also necessary if we are to bring the crisis to an end. Until everyone is protected, everyone will remain at risk of the disease, its adverse economic effects, or both.

As the only truly global approach available, COVAX’s importance cannot be overstated. Although there are more than 200 COVID-19 vaccines in development, and at least 35 clinical trials underway, the vast majority are likely to fail. Historically, candidate vaccines at the preclinical stage have less than a 10% chance of succeeding. And of those that do advance to the clinical trials stage, only around 20% will ultimately be approved. Given these odds, even wealthy governments that are currently negotiating bilateral deals with individual vaccine manufacturers cannot guarantee access to a vaccine on their own.

By contrast, COVAX is specifically designed to maximize the chances of success by investing in the development and manufacture of a large number of vaccine candidates at the same time. With the world’s largest and most diverse vaccine portfolio – which currently comprises nine candidates already in development and a further nine or more under evaluation – COVAX will act as a global insurance policy. Under this framework, member countries that have bilateral deals will still have vaccine access options in the event that those gambles fail, and the majority of countries that have no other options will be extended a critical lifeline.

COVAX’s initial aim is to have two billion vaccine doses available by the end of 2021, as that should be enough to protect high-risk/vulnerable populations and frontline health-care workers. But to hit that target, we first need the legally binding commitments of as many countries as possible.

After the sign-up deadline of September 18, the priority will be to complete the development and testing process to ensure that all forthcoming vaccines are both effective and safe. COVAX will need to put in place agreements with drug manufacturers, so that it can begin delivering vaccines at scale as soon as they are approved. And donor funds will be needed to subsidize the purchase of vaccines for low- and lower-middle-income countries.

But even with financial solutions in place, the process of distributing vaccines will pose significant challenges. The delivery of COVID-19 vaccines will be the single largest vaccine deployment the world has ever seen, and it will have to be executed at a time when misinformation (the “infodemic”) is threatening to undermine public confidence in vaccine safety.

Though the pandemic is far from over, we at least have a global solution in sight. COVAX represents the best hope that we have for bringing a prompt end to the crisis. When people look back and marvel at how quickly the scientific community and development practitioners responded to the COVID-19 threat, they will be able to point to the speed with which governments put aside national interests in the name of international cooperation and solidarity. Whatever specific moment future historians choose as the pandemic’s turning point, there will be little doubt that the creation and widespread adoption of the COVAX framework played an indispensable role in ending it.

::::::

The Lancet
Sep 19, 2020 Volume 396 Number 10254 p799-866, e30-e40
https://www.thelancet.com/journals/lancet/issue/current
Comment
Legal agreements: barriers and enablers to global equitable COVID-19 vaccine access
Alexandra L Phelan, Mark Eccleston-Turner, Michelle Rourke, Allan Maleche, Chenguang Wang

Law can serve as both an enabler and a barrier to global health, equity, and justice.1 The impact of legal determinants of health on the COVID-19 pandemic is evident where law is being used as a mechanism to enable or prevent global equitable access to COVID-19 vaccines. Barriers to equitable access are partly driven by vaccine nationalism2 with governments seeking to use law to secure priority access to future vaccines through Advance Purchase Agreements (APAs) with vaccine manufacturers. These bilateral legal agreements can be in a nation’s interest, but given the uncertain success of individual COVID-19 vaccine candidates and the global spread of SARS-CoV-2, APAs are a gamble and erode collaboration between countries. Importantly, such bilateral legal agreements are likely to contribute to inequities and potentially extend the pandemic’s time frame. By contrast, multilateral legal agreements could be the path back to global health security and justice by re-establishing norms of international solidarity, committing to global equitable vaccine access initiatives, and laying a foundation for a post-pandemic era built on multilateralism and cooperation.

In the lead-up to the World Health Assembly (WHA) in May, 2020, current and former politicians and civil society leaders from around the world, including the President of Ghana, Nana Akufo-Addo, the Prime Minister of Pakistan, Imran Khan, and the President of South Africa and Chair of the African Union, Cyril Ramaphosa, called for a “bold international agreement” that guarantees global equitable access to vaccines as global public goods.3 At the WHA, China’s President Xi Jinping stated that any Chinese vaccine developed will be a “global public good”, and contribute to “ensuring accessibility and affordability in developing countries”.4 The only resolution adopted during the truncated WHA recognised immunisation, rather than vaccines themselves, as a global public good.5 However, since then, the global legal landscape has shifted from a rhetoric of global public goods to a reality largely based on nationalism. According to WHO, there are more than 170 COVID-19 candidate vaccines in development.6 Although only eight of those vaccine candidates are now in phase 3 trials,7 some wealthy nations have secured more than 2 billion doses of potential future COVID-19 vaccines using APAs.8

APAs are legally binding contracts whereby one party, such as a government, commits to purchasing from a vaccine manufacturer a specific number or percentage of doses of a potential vaccine at a negotiated price if it is developed, licensed, and proceeds to manufacture. These bilateral agreements often secure priority access to vaccine and manufacturing capacity. Governments of countries that disagree with the ethics and effectiveness of APAs or that do not have the financial resources to purchase vaccines at comparable prices or engage in commercial negotiations are at risk of not having access to vaccines when they first become available and of having access delays while manufacturing capacity is fulfilled first by wealthy countries’ orders. This was the case during the 2009 influenza A H1N1 pandemic when many APAs held by high-income countries (HICs) were used to secure their priority access to vaccine, making procurement in other countries more difficult.9 APAs were used so extensively in 2009 that more than 56% of pandemic influenza vaccine manufacturers surveyed by WHO were unable to commit to guaranteeing 10% of real-time vaccine production for purchase by UN agencies due to pre-existing commitments under APAs with HICs.10 Governments that enter into APAs for candidate vaccines that do not demonstrate evidence of safety and efficacy also risk not getting immediate or sufficient access to successful vaccine candidates.

APAs are not always legal tools for vaccine nationalism but can be used by global health organisations to secure vaccines for low-income and middle-income countries (LMICs) as part of an Advanced Market Commitment (AMC). Global health organisations, most notably Gavi, The Vaccine Alliance, have used donor-funded AMCs to enter into APAs with vaccine manufacturers to supply a guaranteed number of vaccine doses to countries with limited profit-based markets; AMCs were used in this way for childhood pneumococcal vaccines and Ebola vaccines.11 In June, 2020, Gavi established the COVID-19 Vaccine Global Access (COVAX) AMC to use funds from donors and HIC governments to purchase a guaranteed volume supply of COVID-19 vaccines to be distributed to LMICs participating in the COVAX Facility.12

Launched in April, 2020, and co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and WHO, the COVAX Facility is a platform for all participating governments to access a diversified portfolio of COVID-19 vaccines when they become available, distributing risk across multiple vaccine candidates. The COVAX Facility aims to have enough doses of COVID-19 vaccines for at least 20% of participating countries’ populations, with a goal of 2 billion doses by the end of 2021. Civil society has criticised COVAX for negotiating prices that include profit rather than vaccines at cost as a global public good, the lack of transparency of contracts entered into with vaccine manufacturers, limits on civil society participation, failure to address potential impacts of intellectual property rights on pandemic vaccines, and governance questions, including the role of WHO and limited experience procuring vaccines for middle-income countries and HICs.13 The latter point led the EU to decline using the COVAX Facility for purchasing vaccines, stating that bilateral APAs enable it to access vaccines faster and at a lower cost. On Aug 24, 2020, the WHO Director-General noted that although 172 countries are in discussions about joining the COVAX Facility, more support, particularly from wealthy countries, is “urgently needed” to “secure enough doses to rollout the vaccines” and address equitable vaccine access.14 Despite not participating in the COVAX Facility for purchasing its own COVID-19 vaccines, on Aug 31, 2020, the EU made a €400 million commitment to participation in parallel to existing APAs.15

Allocation questions for COVID-19 vaccines have focused on equitable distribution within countries, including prioritising vulnerable populations and health-care and essential workers. However, justice also demands consideration of the equitable vaccine distribution between countries. Under the Pandemic Influenza Preparedness (PIP) Framework—the only international legal instrument for the global equitable distribution of vaccines—WHO intends to distribute pandemic influenza vaccines that are secured under contracts with manufactures to countries on the basis of public health risk and needs.16 However, in a pandemic with a restricted supply of available vaccine, public health need alone is unlikely to guide decisions, especially in the early stages of vaccine distribution when supply will be limited and the need will be equally high across many countries. Furthermore, unlike pandemic influenza, there is not an international legal instrument, agreed to by all WHO member states, for COVID-19. Nor is there yet public international agreement on how distribution of COVAX Facility (or alternative platforms) vaccines should occur. WHO has developed a proposal for a Global Framework to Ensure Equitable and Fair Allocation of COVID-19 Products, highlighting how a global access mechanism would distribute risk and maximise equitable allocation between countries; however, the legal process and form for adoption of such a framework has not been publicly proposed.17

Despite the lack of a specific international agreement for COVID-19 vaccines, 171 countries already have legally binding obligations under the International Covenant on Economic, Social, and Cultural Rights (1966) to take steps, individually and through international assistance, to realise the right to health and the right to enjoy the benefits of scientific research and its applications, without discrimination. Respecting, protecting, and fulfilling these rights in the context of COVID-19 would mean ensuring that COVID-19 vaccines are available, accessible, acceptable, and of good quality, in all countries.18

Multilateral commitment is needed to help pre-empt an additional legal risk arising from vaccine nationalism that could render multilateral and some bilateral APAs ineffective, such as the use of government export controls. During the 2009 influenza A H1N1 pandemic, governments in HICs with vaccine manufacturers restricted export of vaccines until domestic needs had been met.19 As a result, even where governments or international institutions have entered into APAs, vaccine nationalism in the country of manufacture could embargo or requisition vaccines, delaying global distribution.

Any international governance platform for COVID-19 vaccines, including the COVAX Facility or a new mechanism, will only succeed if there is global momentum and commitment to global equitable COVID-19 vaccine access, particularly from HICs. Yet many HICs are currently driving the proliferation of bilateral APAs, entrenching nationalism, and directing future vaccine distribution. In November, 2020, countries will meet for the second part of the pandemic segmented WHA. This meeting might be the last chance all countries have to adopt an international instrument and agree on a mechanism for COVID-19 vaccines before they become available. Any international COVID-19 vaccine allocation framework, even as a non-binding resolution, must establish governance principles, including accountability, transparency, and participation, and define decision makers, increase country commitments to financing and acceptable conduct, and set principles and a mechanism for equitable distribution within and, importantly, between countries. Such an agreement is necessary to protect human rights and ensure transparency, accountability, participation, and equity.3 Finally, at the G20 in late November, 2020, HICs have a crucial opportunity to choose the world we will face if successful COVID-19 vaccines are developed: one where law is not a barrier but a tool for achieving global health equity with justice.

ALP is a consultant for WHO and has previously consulted to Gavi, The Vaccine Alliance. ME-T has previously consulted for WHO on equitable access to pandemic influenza vaccines. ALP, ME-T, and MR are supported by the Arts and Humanities Research Council of the UK, grant: AH/V006924/1. AM and CW declare no competing interests.

::::::

WHO SAGE values framework for the allocation and prioritization of COVID-19 vaccination, 14 September 2020
World Health Organization
14 September 2020 :: 13 pages
PDF: WHO-2019-nCoV-SAGE_Framework-Allocation_and_prioritization-2020.1-eng.pdf
Executive Summary
This Values Framework offers guidance globally on the allocation of COVID-19 vaccines between countries, and to offer guidance nationally on the prioritization of groups for vaccination within countries while supply is limited. The Framework is intended to be helpful to policy makers and expert advisors at the global, regional and national level as they make allocation and prioritization decisions about COVID-19 vaccines. This document has been endorsed by the Strategic Advisory Group of Experts on Immunization (SAGE).

The Framework articulates the overall goal of COVID-19 vaccine deployment, provides six core principles that should guide distribution and twelve objectives that further specify the six principles (Table 1). To provide recommendations for allocating vaccines between countries and prioritizing groups for vaccination within each country, the Values Framework needs to be complemented with information about specific characteristics of available vaccine or vaccines, the benefit-risk assessment for different population groups, the amount and pace of vaccine supply, and the current state of the epidemiology, clinical management, and economic and social impact of the pandemic. Hence, the final vaccination strategy will be defined by the characteristics of vaccine products as they become available.

SAGE is currently engaged in the process of applying the Values Framework to emerging evidence on specific vaccines, and the evolving epidemiology and economic impact of the pandemic. The first stage of this process was the identification of populations and sub-populations which would be appropriate target groups for prioritization under the various values-based objectives in the Framework (Table 2), before data on Phase 3 vaccine performance are not yet available. Specific priority group recommendations for specific vaccines will be made as vaccine products become authorized for use; initial vaccine specific policy recommendations are expected in the final quarter of 2020 or early 2021, depending on timing of and findings from phase 3 vaccine trials.

The Framework also complements the principles on equitable access and fair allocation of COVID-19 health products developed for the ACT Accelerator COVAX facility.

Framework Goals and Principles at a Glance
Overarching goal
COVID-19 vaccines must be a global public good. The overarching goal is for COVID-19 vaccines to contribute significantly to the equitable protection and promotion of human well-being among all people of the world.

Principles
Human Well-Being
Protect and promote human well-being including health, social and economic security, human rights and civil liberties, and child development.
Equal Respect
Recognize and treat all human beings as having equal moral status and their interests as deserving of equal moral consideration.
Global Equity
Ensure equity in vaccine access and benefit globally among people living in all countries, particularly those living in low-and middle-income countries.
National Equity
Ensure equity in vaccine access and benefit within countries for groups experiencing greater burdens from the COVID-19 pandemic.
Reciprocity
Honor obligations of reciprocity to those individuals and groups within countries who bear significant additional risks and burdens of COVID-19 response for the benefit of society.
Legitimacy
Make global decisions about vaccine allocation and national decisions about vaccine prioritization through transparent processes that are based on shared values, best available scientific evidence, and appropriate representation and input by affected parties.

::::::

Statement on COVID-19 Immunization and Equitable Access to Vaccines
World Federation of Public Health Associations [WFPHA] – Taskforce on Immunization
Friday, 18 September 2020

Immunization is one of the most successful public health measures of modern times. In fact, according to a World Health Organization (WHO) report on the prevention of infectious diseases, it is second only to clean water (WHO 2008). Annually immunization prevents an estimated 2.5 million deaths globally and reduces disease-specific treatment costs (WHO 2018).

For all the devastation caused by COVID-19, an important lesson is that the balance needs to shift from treating disease to preventing it. Immunization has an important role to play in prevention not only for infants but throughout life as a key component of healthy ageing. It saves, prolongs and improves the quality of lives, at the same time that it saves time and other resources, leading to sustainable healthcare systems (UK Chief Medical Officers’ Guidelines 2011). Further, immunization has positive long-term impact, contributing to make communities healthier and promote social and economic development.

GAVI, WHO and UNICEF have warned that 80 million children under the age of one are at risk of disease due to disruptions to vital immunisation programmes because of COVID-19 (2). Specific to COVID-19, almost everyone is at risk and may require vaccination if given the opportunity. Hence, it is likely that demand will surpass supply. The concern of the WFPHA Immunisation Taskforce is the tendency for the rich to acquire and pay for the limited supply of available efficacious vaccines to the detriment of the at-risk populations in low income settings.

Not surprisingly, the race to produce a safe and efficacious vaccine for COVID-19 has been on-going and there are indications that success may not be too far away. An important lesson that experience has taught us from previous immunization programs is that, even when effective vaccines are available, vulnerable persons in low income settings usually do not have access to these vaccines for some time, if at all. There is a myriad of reasons for this state of affairs. These include (among others) high cost of vaccination programs for countries, health systems, families and individual, individual’s poor geographical access to vaccination centres, and inadequate supply of available vaccines due to competition. To worsen matters, GAVI (The Vaccine Alliance) indicated (prior to COVID-19) its intention to wean itself off such funding support.

Therefore, the WFPHA Immunisation Taskforce recommends:
1. The international community should widen the process of coming together to support research and development of effective COVID-19 vaccines from multiple centres.
2. The international community should establish a COVID-19 vaccination fund to support needy but resource-constrained countries.
3. Supporting the World Health Organization in its efforts to coordinate the response to COVID-19 and in the development of an appropriate vaccine.
4. National authorities should financially support the WHO and invest in strengthening national health systems with a particular focus on sustainable immunization programs.
5. GAVI should continue to work for equitable distribution of any effective vaccine against COVID-19 and postpone any plans of withdrawing funding support to developing countries.

References
GAVI (2020) COVID-19: massive impact on lower-income countries threatens more disease outbreaks https://www.gavi.org/news/media-room/covid-19-massive-impact-lower-income-countries-threatens-more-disease-outbreaks

WHO (2008) Vaccination greatly reduces disease, disability, death and inequity worldwide. Available at: https://www.who.int/bulletin/volumes/86/2/07-040089/en/. Last accessed: June 2019.

WHO (2018) Vaccines: the powerful innovations bringing WHO’s mission to life every day. Available at: https://www.who.int/news-room/commentaries/detail/vaccines-the-powerful-innovations-bringing-who-s-mission-to-life-every-day. Last accessed: May 2019.

UK Chief Medical Officers’ Guidelines (2011) Physical activity benefits for adults and older adults. Available at: https://www.health-ni.gov.uk/sites/default/files/publications/dhssps/physical-activity-info.pdf. Last accessed: June 2019

::::::

IVAC [to 19 Sep 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
Webinar Recording: Avoiding Barriers to Access for a COVID-19 Vaccine
The International Vaccine Access Center (IVAC) hosted a webinar on September 16th,
Description: Even before the COVID-19 pandemic, countries worked to overcome a myriad of challenges when introducing new safe and effective vaccines. While policy makers and health advocates addressed barriers, from understanding disease burden and cost effectiveness to establishing cold chain systems, preventable diseases spread, sicken populations, and cost lives. Learning from the past failures of vaccine introductions will be crucial for ensuring equitable access to a COVID-19 vaccine. Leaders and scientists in the international vaccine field discussed the barriers to vaccine access we must overcome to avoid and the role the international community will play in promoting equity in delivering a COVID-19 vaccine.
The webinar featured a presentation by Jerome Kim, MD, Director General, IVI.
Watch: https://youtu.be/5U6SYVqhquY
Slides: https://www.jhsph.edu/ivac/wp-content/uploads/2020/09/Presentation_Barriers-to-Vaccine-Access.pdf

Coronavirus [COVID-19] – PHEIC

EMERGENCIES

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

Weekly Epidemiological and Operational updates
last update: 11 September 2020, 20:00 GMT-4
Confirmed cases :: 30 369 778 [week ago: 28 329 790]
Confirmed deaths :: 948 795 [week ago: 911 877]

Weekly Epidemiological Update 
Coronavirus disease 2019 (COVID-19)
14 September 2020
Global epidemiological situation
In the week from 7 through 13 September, there were over 1.8 million new cases of COVID-19, comparable to the previous seven days (Table 1); while deaths increased slightly as compared to the previous week, with over 40 600 deaths reported.
The Region of the Americas has consistently registered the greatest number of reported cases for many weeks. It continues to account for nearly half of the global total of cases even as cases have declined in the reporting week. The African Region also showed a decline in reported cases this week and was the only region to report a decline in deaths.
The European region reported the third-highest number of new cases, amounting to 16% of the global total, and is the region with the second-highest cumulative number of cases per million population (5 172 cases per million population).
In recent weeks schools have been re-opening in a number of countries throughout the six WHO regions. WHO has published both a Question and Answer and guidance on considerations for school-related public health measures in the context of COVID-19…

::::::

WHO Director-General’s opening remarks at the media briefing on COVID-19 – 18 September 2020
18 September 2020
:: COVID-19 has shown that collectively, the world was woefully under prepared.
:: In its new report, the Global Preparedness Monitoring Board lays out the key lessons the world must learn from the pandemic and the concrete actions we can take to protect ourselves.
:: With the right political and financial commitment and investment now, we can prevent and mitigate future pandemics.
:: This is a critical moment for countries and we ask leaders to put targeted measures in place that we know can suppress the spread and ensure that health systems and workers are protected.
:: For people also, we ask you to continue to do the basics.

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

POLIO – PHEIC

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 17 September 2020
:: The Polio Oversight Board (POB) held its second meeting of the year virtually to discuss the programme’s financial requirements for 2021, to receive an update on the recommendations of the GPEI Governance Review and to consider a proposal to develop a new polio programme strategy. Read more on the meeting [10 pages].

:: When the COVID-19 pandemic struck, the acute challenges it posed to both polio and immunization activities presented an unprecedented opportunity to coordinate and reimagine collaboration. Given the new context, the focus of the work shifted to develop an interim Programme of Work for Integrated Actions in the context of COVID-19 (iPOW). The draft iPOW summarizes the current level of integration between GPEI and EPI and, more importantly, identifies critical actions across key priority areas of work to drive synergies and materialize efficiency gains by building on initiatives accelerated by COVID-19 to ensure a successful resumption of all immunization activities. iPOW is open for stakeholder consultation until October 1st, 2020.

:: The GPEI established an nOPV2 Working Group to manage and coordinate the rapid and effective rollout of nOPV2. The group includes representatives from each of the GPEI partner organizations and focuses on research, regulatory, supply, communications, policy, and implementation readiness activities. Take a look at an updated information sheet detailing the structures and linkages of the Working Group.

Summary of new WPV and cVDPV viruses this week (AFP cases and environmental samples):
:: Afghanistan: two WPV1 cases, one WPV1 positive environmental sample and ninecVDPV2 cases
:: Pakistan: two WPV1 cases, eight WPV1 positive environmental samples and sevencVDPV2 cases
:: Democratic Republic of the Congo (DR Congo): nine cVDPV2 cases
:: Somalia: one cVDPV2 case and two positive environmental samples
:: Sudan: one cVDPV2 case
:: Mali: one cVDPV2 positive environmental sample
:: Central African Republic: one cVDPV2 case

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

Ebola – DRC+; WHO/OCHA Emergencies

Emergencies

Ebola – DRC+
Last WHO Situation Report published 23 June 2020
Last WHO DON published 3 July 2020

 Editor’s Note:
After this edition, we will “retire” this special section – with great appreciation to all who contributed to bringing this PHEIC under control!

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

WHO Grade 3 Emergencies [to 19 Sep 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 19 Sep 2020]
Burkina Faso [in French]
:: L’Organisation mondiale de la Santé encourage les pays de la Région africaine à promouvoir des médicaments traditionnels sûrs et efficaces 18 septembre 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
Iraq – No new digest announcements identified
Libya – No new digest announcements identified
Malawi Floods – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Mozambique – No new digest announcements identified
Myanmar – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

::::::

WHO Grade 1 Emergencies [to 19 Sep 2020]

Chad – No new digest announcements identified
Djibouti – Page not responding at inquiry
Kenya – No new digest announcements identified
Mali – No new digest announcements identified
Namibia – viral hepatitis – No new digest announcements identified
Tanzania – No new digest announcements identified

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

UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: Syrian Arab Republic: COVID-19 Humanitarian Update No. 18 As of 17 September 2020

Yemen
– No new digest announcements identified

::::::

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 2019 (COVID-19) Situation Report 44: occupied Palestinian territory, issued 17 September 2020, information for period: 5 March – 17 September 2020

East Africa Locust Infestation
:: Desert Locust situation update – 18 September 2020
The Desert Locust situation continues to improve in Southwest Asia and there are initial signs of improvement in parts of East Africa. Nevertheless, it remains serious in Yemen and other areas of the Horn of Africa. The developing situation is being watched closely along both sides of the Red Sea where it could deteriorate as a result of swarm breeding…

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

WHO & Regional Offices [to 19 Sep 2020]

WHO & Regional Offices [to 19 Sep 2020]

WHO and UNICEF recommit to accelerating health and well-being at all ages
New partnership calls for key actions in universal health coverage, mental health, emergencies and nutrition
18 September 2020 News release Geneva
[See Milestones above for detail]

Keep health workers safe to keep patients safe: WHO
17 September 2020 News release Geneva
The World Health Organization (WHO) is calling on governments and health care leaders to address persistent threats to the health and safety of health workers and patients.
“The COVID-19 pandemic has reminded all of us of the vital role health workers play to relieve suffering and save lives,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “No country, hospital or clinic can keep its patients safe unless it keeps its health workers safe. WHO’s Health Worker Safety Charter is a step towards ensuring that health workers have the safe working conditions, the training, the pay and the respect they deserve.”
The pandemic has also highlighted the extent to which protecting health workers is key to ensuring a functioning health system and a functioning society.
The Charter, released today for World Patient Safety Day, calls on governments and those running health services at local levels to take five actions to better protect health workers. These include steps to protect health workers from violence; to improve their mental health; to protect them from physical and biological hazards; to advance national programmes for health worker safety, and to connect health worker safety policies to existing patient safety policies…

WHO’s three messages for UN75
15 September 2020 News release Geneva, Switzerland
…The first is about equitable access to COVID-19 tools…
…The second message is about maintaining the momentum towards achieving the sustainable development goals. The pandemic risks unravelling decades of gains made in health and development…
…Finally, we must prepare for the next pandemic together, now. COVID-19 has shown us that the world was woefully unprepared – despite the many warning signs and warnings…

 

::::::

Weekly Epidemiological Record, 18 September 2020, vol. 95, 38 (pp. 449–460)
:: Progress in poliovirus containment– worldwide, 2019–2020
:: Performance of acute flaccid paralysis (AFP) surveillance and incidence of poliomyelitis, 2020
:: The Access to COVID-19 Tools (ACT) Accelerator
:: COVID-19 update

 

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: 19 September 2020 Expert panel endorses protocol for COVID-19 herbal medicine clinical trials
:: 17 September 2020 WHO encouraged by South Africa’s declining COVID-19 trend

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
No new digest content identified

WHO European Region EURO
:: Self-testing for HIV at home – successful project in Bulgaria 18-09-2020
:: COVID-19: Regional coherence and a spirit of collective support are crucial 18-09-2020
:: WHO/Europe and the Turkic Council sign a new Memorandum of Understanding strengthening new partnerships in the region 16-09-2020
:: Statement by Dr Hans Henri P. Kluge, WHO Regional Director for Europe, 70th session of the WHO Regional Committee for Europe 16-09-2020
:: In brief: the 70th session of the WHO Regional Committee for Europe (RC70) 15-09-2020

WHO Eastern Mediterranean Region EMRO
:: Statement by WHO’s Regional Director on a resurgence of COVID-19 cases in the Region
15 September 2020 ‒ Today, the situation in the Eastern Mediterranean Region is extremely worrying, with more people being infected every day. In some countries, including Iraq, Morocco, Tunisia and the United Arab Emirates, the significant increase in the number of cases is especially concerning, and highlights an urgent need for more rigorous action. While an upsurge of cases was expected…

WHO Western Pacific Region
:: 17 September 2020 | Media Release
Asia Pacific health and finance ministers stress importance of universal health coverage in COVID-19 era and beyond

:: 16 September 2020 | Feature story
How countries in Asia and the Pacific are working towards universal health coverage and combating COVID-19

CDC/ACIP [to 19 Sep 2020]

CDC/ACIP [to 19 Sep 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
Overview of Testing for SARS-CoV-2 (COVID-19)
Updated Sept. 18, 2020
Note: This document is intended to provide guidance on the appropriate use of testing for SARS-CoV-2 in light of additional testing capacity throughout the country and does not address decisions regarding payment for or insurance coverage of such testing.
Summary of Changes
Clarifications made on September 18, 2020
Due to the significance of asymptomatic and pre-symptomatic transmission, this guidance further reinforces the need to test asymptomatic persons, including close contacts of a person with documented SARS-CoV-2 infection.

CDC Releases Indicators for Dynamic School Decision-Making
Tuesday, September 15, 2020

Screen Shot 2020-09-20 at 9.31.38 PM

Today, CDC released indicators to help schools make dynamic decisions about in-person learning as local conditions evolve throughout the pandemic. When coupled with local data about community spread, these indicators are an important tool to help local health officials, school administrators, and communities prepare, plan, and respond to COVID-19. These indicators are the latest resources CDC has provided for schools during the COVID-19 pandemic, and they supplement previously released CDC guidance.

To make decisions about operational conditions, like beginning, continuing, or pausing in-person learning, schools in cooperation with local health departments must be able to monitor the local spread of COVID-19 and assess their own ability to implement prevention and mitigation strategies for students, teachers, and staff. This new resource includes core and secondary indicators to help local officials and school districts assess their risk for COVID-19 introductions into and spread within their schools. The indicators reflect the mutually dependent relationship between schools and their surrounding communities. The measures do not set strict cutoffs for individual schools and school systems; they should be used as guideposts for monitoring local conditions and adjusting teaching models as needed.

Whether at higher or lower risk, schools and local officials are encouraged to use the indicators, existing guidance, and other available information as they prepare for a return to or the continuation of in-person learning, implement plans for safer operations, and quickly respond to COVID-19 cases and threats.

MMWR News Synopsis Friday, September 18, 2020

MMWR News Synopsis Friday, September 18, 2020
Cancers Associated with Human Papillomavirus in American Indian and Alaska Native Populations — United States, 2013–2017

Serial Testing for SARS-CoV-2 and Virus Whole Genome Sequencing Inform Infection Risk at Two Skilled Nursing Facilities with COVID-19 Outbreaks — Minnesota, April–June 2020

Preventing COVID-19 Outbreaks in Long-Term Care Facilities Through Preemptive Testing of Residents and Staff Members — Fulton County, Georgia, March–May 2020

Association Between CMS Quality Ratings and COVID-19 Outbreaks in Nursing Homes — West Virginia, March 17–June 11, 2020

Decreased Influenza Activity During the COVID-19 Pandemic — United States, Australia, Chile, and South Africa, 2020

Transmission Dynamics of COVID-19 Outbreaks Associated with Child Care Facilities — Salt Lake City, Utah, April–July 2020

SARS-CoV-2–Associated Deaths Among Persons Aged <21 Years — United States, February 12–July 31, 2020

Progress Toward Poliovirus Containment Implementation — Worldwide, 2019–2020

China CDC

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

 

National Health Commission of the People’s Republic of China
http://en.nhc.gov.cn/
News
Sept 19: Daily briefing on novel coronavirus cases in China
On Sept 18, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 14 new cases of confirmed infections.

Rapid progress made in developing vaccine
Updated: 2020-09-17 China Daily Global
Expert says it may be available for public use as early as November
[See COBVID above for detail]

Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 19 Sep 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 19 Sep 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

 

BMGF – Gates Foundation [to 19 Sep 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
SEPTEMBER 14, 2020
Gates Foundation’s Annual Goalkeepers Report Shows COVID-19 Has Stalled 20 Years of Progress, Calls for Global Response to End the Pandemic
Report shows how economic damage has reinforced inequities and derailed achievement of the UN Sustainable Development Goals; spotlights countries innovating to meet challenges

 

Bill & Melinda Gates Medical Research Institute [to 19 Sep 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

 

CARB-X [to 19 Sep 2020]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
No new digest content identified.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 19 Sep 2020]
http://cepi.net/
COVAX: A Moment of Truth in the Pandemic
18 Sep 2020
{See Week in Review above for detail]

 

EDCTP [to 19 Sep 2020]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
No new digest content identified.

 

Emory Vaccine Center [to 19 Sep 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 19 Sep 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020
CHMP, Last updated: 18/09/2020
… The Committee recommended granting marketing authorisations for two vaccines: MenQuadfi (meningococcal group A, C, W and Y conjugate vaccine), for prophylaxis against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y; and Supemtek (Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture)), for prophylaxis against influenza…

 

 

News: EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation
CHMP, Last updated: 18/09/2020

 

European Vaccine Initiative [to 19 Sep 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 19 Sep 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
September 18, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 18, 2020
Testing updates:
As of today, 248 tests are authorized by FDA under EUAs; these include 198 molecular tests, 46 antibody tests, and 4 antigen tests.

September 17, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 17, 2020

September 16, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 16, 2020
On September 15, 2020, the FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection, indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting, as well as the sedation of non-intubated patients prior to and/or during surgical and other procedures.

September 15, 2020 – Coronavirus (COVID-19) Update: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests
Today, the U.S. Food and Drug Administration published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA. The FDA provided these standardized samples, known as a reference panel, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their Emergency Use Authorization (EUA)…

September 15, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 15, 2020

September 14, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 14, 2020

 

Fondation Merieux [to 19 Sep 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

 

Gavi [to 19 Sep 2020]
https://www.gavi.org/
News releases
16 September 2020
A record-breaking year for childhood immunisation
Looking back over last year, Gavi’s 2019 Annual Progress Report is the fourth in a series of five covering this strategic period. Highlighting key data points, milestones and partnerships, the report offers insights into our progress during what was, in many ways, a banner year for the Vaccine Alliance.

 

GHIT Fund [to 19 Sep 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.

 

Global Fund [to 19 Sep 2020]
https://www.theglobalfund.org/en/news/
News/Updates
News
Global Fund Partnership Has Saved 38 Million Lives – but COVID-19 Could Wipe Out Progress
14 September 2020
A new report by the Global Fund to Fight AIDS, Tuberculosis and Malaria is a call to action to urgently invest to protect decades of progress against HIV, TB and malaria that are being derailed as a knock-on effect of the COVID-19 pandemic.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 19 Sep 2020]
https://www.glopid-r.org/news/
News
The Global Preparedness Monitoring Board releases report: “A World In Disorder”
16/09/2020
[See Milestones above for detail]

 

Hilleman Laboratories [to 19 Sep 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 19 Sep 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Release
No new digest content identified.

 

IAVI [to 19 Sep 2020]
https://www.iavi.org/newsroom
FEATURES
September 15, 2020
Updated: The Effects of COVID-19 on IAVI Clinical Programs

 

 

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/
Announcements
No new digest content identified.

 

IFRC [to 19 Sep 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Asia Pacific, Indonesia, Malaysia, Myanmar, Pakistan
Asia Survey: 1 in 2 blame foreigners and rule-breakers for COVID-19
Kuala Lumpur/Geneva, 17 September 2020 – A major new survey in four Asian countries reveals nearly one in two people blame specific groups for spreading COVID-19.  The survey shows that people are blaming particular groups for spreading the coronavirus …
17 September 2020

 

IRC International Rescue Committee [to 19 Sep 2020]
http://www.rescue.org/press-release-index
Media highlights {Selected]
[No new digest content identified]

 

IVAC [to 19 Sep 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
Webinar Recording: Avoiding Barriers to Access for a COVID-19 Vaccine
The International Vaccine Access Center (IVAC) hosted a webinar on September 16th,
Description: Even before the COVID-19 pandemic, countries worked to overcome a myriad of challenges when introducing new safe and effective vaccines. While policy makers and health advocates addressed barriers, from understanding disease burden and cost effectiveness to establishing cold chain systems, preventable diseases spread, sicken populations, and cost lives. Learning from the past failures of vaccine introductions will be crucial for ensuring equitable access to a COVID-19 vaccine. Leaders and scientists in the international vaccine field discussed the barriers to vaccine access we must overcome to avoid and the role the international community will play in promoting equity in delivering a COVID-19 vaccine.
The webinar featured a presentation by Jerome Kim, MD, Director General, IVI.
Video: https://youtu.be/5U6SYVqhquY
Slides: https://www.jhsph.edu/ivac/wp-content/uploads/2020/09/Presentation_Barriers-to-Vaccine-Access.pdf

 

IVI [to 19 Sep 2020]
http://www.ivi.int/
Selected IVI News & Announcements
Typhoid: Study confirms Vi-DT conjugate vaccine is safe and immunogenic in children 6-23 months of age
September 17, 2020 – SEOUL, South Korea – A new study conducted by IVI in collaboration with SK bioscience shows that single-dose and two-dose regimens of Vi-DT typhoid conjugate vaccine (TCV) are safe and immunogenic in children 6-23 months of age, a group with high rates of typhoid fever in resource-limited settings. The findings from this study newly published online in The Lancet’s EClinicalMedicine describe the successful completion and analysis of a Phase II clinical trial of Vi-DT six months after vaccination…

 

JEE Alliance [to 19 Sep 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 19 Sep 2020]
http://www.msf.org/
Latest [Selected Announcements]
Mediterranean migration
“Enough is enough”: Time to stop the cycle of suffering for refugees on Greek islands
Project Update 17 Sep 2020

Coronavirus COVID-19 pandemic
MSF works to prevent spread of COVID-19 among indigenous people in Mato Grosso do Sul
Project Update 17 Sep 2020

Central African Republic
In times of COVID-19, malaria remains the number one killer of children in CAR
Project Update 15 Sep 2020

 

National Vaccine Program Office – U.S. HHS [to 19 Sep 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC Meetings
September 23-24, 2020 Meeting (Virtual)
Selected Agenda Topics:
:: Serving Up Equity: Health-In-All Approaches for COVID-19 Vaccination [Panel]
:: Allocation and Prioritization: Considerations and Recommendations for the Distribution of
COVID-19 Vaccines [Dr. Ezekiel Emanuel, University of Pennsylvania; CDC tbd]
:: Perspectives from the Field: Operation Warp Speed [Dr. Moncef Slaoui, HHS]
:: The Infodemic, COVID-19 Immunization, and the Public’s Health [Panel]
:: Immunization Information Systems to Support the COVID-19 Response [Panel]

 

NIH [to 19 Sep 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH funds community engagement research efforts in areas hardest hit by COVID-19
September 16, 2020 — Outreach will focus on COVID-19 awareness and education research, especially among African Americans, Hispanics/Latinos, and American Indians.
The National Institutes of Health today announced a $12 million award for outreach and engagement efforts in ethnic and racial minority communities disproportionately affected by the COVID-19 pandemic. The award to RTI International, a non-profit research institution, will support teams in 11 states established as part of the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities. These teams have received initial funding to immediately create CEAL programs, and RTI will serve as the Technical and Administrative Support and Coordination (TASC) center.
The CEAL research teams will focus on COVID-19 awareness and education research, especially among African Americans, Hispanics/Latinos, and American Indians — populations that account for over half of all reported cases in the United States. They also will promote and facilitate the inclusion and participation of these groups in vaccine and therapeutic clinical trials to prevent and treat the disease.
The communities of special focus include counties in Alabama, Arizona, California, Florida, Georgia, Louisiana, Michigan, Mississippi, North Carolina, Tennessee and Texas…

NIH awards contracts to develop innovative digital health technologies for COVID-19
September 15, 2020 — The projects represent a broad range of solutions for immediate public health needs related to the pandemic.
The National Institutes of Health has awarded seven contracts to companies and academic institutions to develop digital health solutions that help address the COVID-19 pandemic. The work could lead to user-friendly tools such as smartphone apps, wearable devices, and software that can identify and trace contacts of infected individuals, keep track of verified COVID-19 test results, and monitor the health status of infected and potentially infected individuals.
The National Cancer Institute (NCI) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB), both part of NIH, selected the seven projects from nearly 200 different ideas. The projects represent a broad range of solutions for immediate public health needs related to the pandemic, and several focus on solutions for medically underserved communities and people with limited access to health care, who are disproportionally affected by COVID-19…

Substance use disorders linked to COVID-19 susceptibility
September 14, 2020 — NIH research finds higher risk and worse outcomes for those with addiction.

 

PATH [to 19 Sep 2020]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

 

Sabin Vaccine Institute [to 19 Sep 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 19 Sep 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
18 September 2020
COVID-19 brings Jamaican people living with HIV closer together

16 September 2020
Pacific Unite concert promotes solidarity during the COVID-19 pandemic

15 September 2020
Somalia: building a stronger primary health care system

15 September 2020
Shelter for key populations in Kyrgyzstan

 

 

R

 

Unitaid [to 19 Sep 2020]
https://unitaid.org/
Featured News
No new digest content identified.

 

Vaccination Acceptance Research Network (VARN) [to 19 Sep 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 19 Sep 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 19 Sep 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 19 Sep 2020]
https://wellcome.ac.uk/news
Opinion | 16 September 2020
Could Covid-19 be fuelling drug resistance?
Gemma Buckland Merrett
Science Lead, Drug-Resistant Infections Wellcome
We need to understand the impact of Covid-19 on wider health issues to shape better public health responses and limit long-term consequences. Drug resistance is one of these, Gemma Buckland-Merrett explains.

 

The Wistar Institute [to 19 Sep 2020]
https://www.wistar.org/news/press-releases
Press Releases
Press Release
Sep. 14, 2020
Wistar Appoints Ami Patel, Ph.D., as Caspar Wistar Fellow
Caspar Wistar Fellowship launches the careers of up-and-coming biomedical researchers as top scientific leaders.

 

WFPHA: World Federation of Public Health Associations [to 19 Sep 2020]
https://www.wfpha.org/
Latest News
Statement on COVID-19 Immunization and Equitable Access to Vaccines
Friday, 18 September 2020
[See COVID above for full text]

 

World Organisation for Animal Health (OIE) [to 19 Sep 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 19 Sep 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.

 

BIO [to 19 Sep 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 19 Sep 2020]
http://www.dcvmn.org/
News; Upcoming events
14 September 2020
DCVMN Congratulates WHO African Region for Wild Polio-Free Certification
Brazzaville 25th August 2020 – The Africa Regional Certification Commission certified the WHO African Region as wild polio-free after four years without a case. With this historic milestone, five of the six WHO regions – representing over 90% of the world’s population – are now free of the wild poliovirus, moving the world closer to achieving global polio eradication…
… DCVMN company members are proud of contributing towards eradication with supply of polio vaccines to the African continent.
Despite a challenging year for global health, the certification of the African region as wild poliovirus-free is a sign of hope and progress. The resources and expertise used to eliminate wild polio have significantly contributed to Africa’s public health and outbreak response systems. The polio programme provides health benefits to local communities, from supporting the African region’s response to COVID-19 to bolstering routine immunization against other vaccine-preventable diseases.

 

ICBA – International Council of Biotechnology Associations [to 19 Sep 2020]
https://internationalbiotech.org/
News
No new digest content identified.

 

IFPMA [to 19 Sep 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA Statement on the G-FINDER Report “Landscape of Emerging Infectious Disease R&D: Preventing the Next
17 September 2020
The latest G-Finder report “Landscape of Emerging Infectious Disease R&D: Preventing the next pandemic” shows that to be better prepared in the future, the R&D funding needs to be more diversified and supported by a wider range of funders. It also highlights the central role that product development partnerships (PDPs) and initiatives such as the Coalition for Epidemic Preparedness Innovations (CEPI), play to provide a coordination mechanism which pools funding from different organizations to advance research.

IFPMA Statement to G20 Health and Finance Ministers
17 September 2020
[See G20 above for detail]

Safety of vaccinated individuals is the top priority in development of COVID-19 vaccines
15 September 2020
IFPMA is strongly committed to rigorous regulatory standards for approval of COVID-19 treatments and vaccines. No matter how urgently action is needed against the coronavirus public health emergency, it is imperative that the highest standards of quality, safety and efficacy are upheld everywhere. IFPMA member companies are fully committed to transparency in reporting clinical trial results whether these are good or bad; they support the need to inform the public of what they know, as well as what they don’t know about the vaccines in development.

The innovative vaccine industry voiced its strong commitment to rigorous regulatory standards for approval of COVID-19 vaccines in a statement. As part of this commitment, leading vaccine manufacturers issued a pledge to make the safety and well-being of vaccinated individuals a the top priority in development of the first COVID-19 vaccines.

Coinciding with the launch of the pledge, Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) wrote in an Opinion in The Financial Times: “We must prioritise thorough validation of the results of pre-clinical and clinical trials by independent expert bodies. Only the most rigorous application of science and openness in the regulatory process can ensure that everyone, starting with healthcare workers, has confidence in Covid-19 vaccines once they have been properly approved”.

 

PhRMA [to 19 Sep 2020]
http://www.phrma.org/
Selected Press Releases, Statements
Coming together to fight COVID-19: A conversation with Albert Bourla, Chairman & CEO of Pfizer, Inc.
Stephen J. Ubl   |     September 17, 2020
Over the last seven months, our industry has been working around the clock to combat the COVID-19 virus, including developing potential therapeutics to treat COVID-19 and vaccines to prevent future infections.
Last week, I had the opportunity to connect with Albert Bourla, Chairman & CEO of Pfizer Inc., about the fight against COVID-19

Guest Post: How proactivity and planning helped Novartis ensure a stable supply of medicines during COVID-19
Guest Contributor   |     September 16, 2020
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view. Today, we are pleased to welcome a guest post from Steffen Lang, Ph.D., Global Head of Novartis Technical Operations to discuss how Novartis has plans in place to help ensure their supply chains remain operational even in unexpected situations like COVID-19.

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

Postmarketing Safety of Vaccines Approved by the U.S. Food and Drug Administration – A Cohort Study

Annals of Internal Medicine
15 September 2020 Volume 173, Issue 6
http://annals.org/aim/issue

 

Original Research
Postmarketing Safety of Vaccines Approved by the U.S. Food and Drug Administration – A Cohort Study
Noam Tau, MD, Dafna Yahav, MD, and Daniel Shepshelovich, MD
Vaccinations are an important public health strategy that has reduced morbidity and mortality from many infectious diseases. Postmarketing surveillance helps to detect vaccine-related adverse events or long-term complications. This cohort study describes the prevalence and types of safety issues reported for vaccines approved by the U.S. Food and Drug Administration between 1996 and 2015.
Conclusion:
Over a 20-year period, vaccines were found to be remarkably safe. A large proportion of safety issues were identified through existing postmarketing surveillance programs and were of limited clinical significance. These findings confirm the robustness of the vaccine approval system and postmarketing surveillance.

Maternal vaccinations coverage and reasons for non-compliance – a cross-sectional observational study

BMC Pregnancy and Childbirth
http://www.biomedcentral.com/bmcpregnancychildbirth/content
(Accessed 19 Sep 2020)

 

Maternal vaccinations coverage and reasons for non-compliance – a cross-sectional observational study
Maternal influenza and pertussis vaccinations have been proven safe and effective in reducing maternal and infant morbidity and mortality. Though recommended, not all pregnant women receive these important vac… [Israel]
Authors: David Drezner, Michal Youngster, Hodaya Klainer and Ilan Youngster
Citation: BMC Pregnancy and Childbirth 2020 20:541
Content type: Research article
Published on: 16 September 2020

Spatial access inequities and childhood immunisation uptake in Kenya

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 19 Sep 2020)

 

Spatial access inequities and childhood immunisation uptake in Kenya
Poor access to immunisation services remains a major barrier to achieving equity and expanding vaccination coverage in many sub-Saharan African countries. In Kenya, the extent to which spatial access affects i…
Authors: Noel K. Joseph, Peter M. Macharia, Paul O. Ouma, Jeremiah Mumo, Rose Jalang’o, Peter W. Wagacha, Victor O. Achieng, Eunice Ndung’u, Peter Okoth, Maria Muñiz, Yaniss Guigoz, Rocco Panciera, Nicolas Ray and Emelda A. Okiro
Citation: BMC Public Health 2020 20:1407
Content type: Research article
Published on: 15 September 2020

Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs

Ethics & Human Research
Volume 42, Issue 5 Pages: 1-40 September–October 2020
https://onlinelibrary.wiley.com/toc/25782363/current

 

Participants with autism • Big data and pragmatic trials • Covid‐19 research
Articles
Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs
Agata Ferretti, Marcello Ienca, Samia Hurst, Effy Vayena
Pages: 17-28
First Published: 16 September 2020
ABSTRACT
The increased use of big data in the medical field has shifted the way in which biomedical research is designed and carried out. The novelty of techniques and methods brought by big data research brings new challenges to institutional review boards (IRBs). Yet it is unclear if IRBs should be the responsible oversight bodies for big data research and, if so, which criteria they should use. A large but heterogenous set of ethics guidelines and normative responses have emerged to address these issues. In this study, we conducted a scoping review of soft‐law documents and guidelines with the aim of assessing ongoing normative efforts that are proliferating in this domain. We also synthesize a set of recurrent guidelines that could work as a baseline to create a harmonized process for big data research ethics.

HIV/AIDS research in Africa and the Middle East: participation and equity in North-South collaborations and relationships

Globalization and Health
http://www.globalizationandhealth.com/

 

Articles
HIV/AIDS research in Africa and the Middle East: participation and equity in North-South collaborations and relationships
HIV/AIDS has attracted considerable research attention since the 1980s. In the current context of globalization and the predominance of cooperative work, it is crucial to analyze the participation of the countries and regions where the infection is most prevalent. This study assesses the participation of African countries in publications on the topic, as well as the degree of equity or influence existing in North-South relations.
Authors: Gregorio González-Alcaide, Marouane Menchi-Elanzi, Edy Nacarapa and José-Manuel Ramos-Rincón
Content type: Research
17 September 2020

Budget line items for immunization in 33 African countries

Health Policy and Planning
Volume 35, Issue 7, August 2020
https://academic.oup.com/heapol/issue/35/6

 

Original Articles
Budget line items for immunization in 33 African countries
Ulla K Griffiths, Jennifer Asman, Alex Adjagba, Marina Yo, James O Oguta
Health Policy and Planning, Volume 35, Issue 7, August 2020, Pages 753–764, https://doi.org/10.1093/heapol/czaa040
Abstract
The Global Strategy for Women’s Children’s and Adolescents’ Health emphasizes accountability as essential to ensure that decision-makers have the information required to meet the health needs of their populations and stresses the importance of tracking resources, results, and rights to see ‘what works, what needs improvement and what requires increased attention’. However, results from accountability initiatives are mixed and there is a lack of broadly applicable, validated tools for planning, monitoring and evaluating accountability interventions. This article documents an effort to transform accountability markers—including political will, leadership and the monitor–review–act cycle—into a measurement tool that can be used prospectively or retrospectively to plan, monitor and evaluate accountability initiatives. It describes the development process behind the tool including the literature review, framework development and subsequent building of the measurement tool itself. It also examines feedback on the tool from a panel of global experts and the results of a pilot test conducted in Bauchi and Gombe states in Nigeria. The results demonstrate that the tool is an effective aid for accountability initiatives to reflect on their own progress and provides a useful structure for future planning, monitoring and evaluation. The tool can be applied and adapted to other accountability mechanisms working in global health.

The development of a new accountability measurement framework and tool for global health initiatives

Health Policy and Planning
Volume 35, Issue 7, August 2020
https://academic.oup.com/heapol/issue/35/6

 

The development of a new accountability measurement framework and tool for global health initiatives
Adriane Martin Hilber, Patricia Doherty, Andrea Nove, Rachel Cullen, Tunde Segun
Health Policy and Planning, Volume 35, Issue 7, August 2020, Pages 765–774, https://doi.org/10.1093/heapol/czz170

An analysis of the strategic plan development processes of major public organisations funding health research in nine high-income countries worldwide

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 19 Sep 2020]

 

Research
An analysis of the strategic plan development processes of major public organisations funding health research in nine high-income countries worldwide
There have been claims that health research is not satisfactorily addressing healthcare challenges. A specific area of concern is the adequacy of the mechanisms used to plan investments in health research. How…
Authors: Cristina Morciano, Maria Cristina Errico, Carla Faralli and Luisa Minghetti
Citation: Health Research Policy and Systems 2020 18:106
Published on: 18 September 2020

Transforming the practice of medicine through team science

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 19 Sep 2020]

Transforming the practice of medicine through team science
The translation of biomedical research discoveries into clinical practice is marked by extended timelines (averaging 17 years) and multiple sequential process steps. However, even after a drug, device, diagnostic tool or unique therapeutic procedure successfully navigates through clinical testing to approval, real barriers remain in applying and scaling the innovation in practice.

 

Authors: Jason H. Pitzen, Heidi L. Dieter, Darren L. Gronseth, Amber K. Dahl, Venessa L. Boyle, Tharana Maran, C. Michel Harper Jr and Gregory J. Gores
Citation: Health Research Policy and Systems 2020 18:104
Content type: Study Protocol
Published on: 17 September 2020

Reverse vaccinology assisted designing of multiepitope-based subunit vaccine against SARS-CoV-2

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 19 Sep 2020]

 

Reverse vaccinology assisted designing of multiepitope-based subunit vaccine against SARS-CoV-2
Authors: Muhammad Tahir ul Qamar, Farah Shahid, Sadia Aslam, Usman Ali Ashfaq, Sidra Aslam, Israr Fatima, Muhammad Mazhar Fareed, Ali Zohaib and Ling-Ling Chen
Content type: Research Article
16 September 2020

COVID-19 and routine childhood immunization in Africa: Leveraging systems thinking and implementation science to improve

International Journal of Infectious Diseases
September 2020 Volume 98, p1-502
https://www.ijidonline.com/issue/S1201-9712(20)X0010-5

 

COVID-19 and routine childhood immunization in Africa: Leveraging systems thinking and implementation science to improve immunization system performance
Abdu A. Adamu, Rabiu I. Jalo, Desire Habonimana, Charles S. Wiysonge
p161–165
Published online: June 24, 2020

Advancing COVID-19 vaccines – avoiding different regulatory standards for different vaccines and need for open and transparent data sharing

International Journal of Infectious Diseases
September 2020 Volume 98, p1-502
https://www.ijidonline.com/issue/S1201-9712(20)X0010-5

 

Advancing COVID-19 vaccines – avoiding different regulatory standards for different vaccines and need for open and transparent data sharing
Eskild Petersen, Christian Wejse, Alimuddin Zumla
p501–502
Published online: August 18, 2020
[See COVID above for abstracts]

Association of Routine Infant Vaccinations With Antibody Levels Among Preterm Infants

JAMA
September 15, 2020, Vol 324, No. 11, Pages 1019-1116
https://jamanetwork.com/journals/jama/currentissue

 

Original Investigation
Association of Routine Infant Vaccinations With Antibody Levels Among Preterm Infants
Elsbeth D. M. Rouers, MD; Patricia C. J. Bruijning-Verhagen, MD, PhD; Pieter G. M. van Gageldonk, BSc; et al.
has active quiz
JAMA. 2020;324(11):1068-1077. doi:10.1001/jama.2020.12316
This cohort study evaluates IgG antibody concentrations in preterm infants after administration of combination diphtheria–tetanus toxoids–acellular pertussis–inactivated poliomyelitis–Haemophilus influenza type b–and hepatitis B (DTaP-IPV-Hib-HepB) and pneumococcal conjugate vaccines.

Policies Among US Pediatricians for Dismissing Patients for Delaying or Refusing Vaccination

JAMA
September 15, 2020, Vol 324, No. 11, Pages 1019-1116
https://jamanetwork.com/journals/jama/currentissue

 

Research Letter
Policies Among US Pediatricians for Dismissing Patients for Delaying or Refusing Vaccination
Sean T. O’Leary, MD, MPH; Jessica R. Cataldi, MD, MSCS; Megan C. Lindley, MPH; et al.
JAMA. 2020;324(11):1105-1107. doi:10.1001/jama.2020.10658
This survey study assesses US pediatrician practices and office policies in response to parents who either refuse primary vaccinations or request to spread out individual vaccines in the primary series.

Addressing Influenza Vaccination Disparities During the COVID-19 Pandemic

JAMA
September 15, 2020, Vol 324, No. 11, Pages 1019-1116
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
Addressing Influenza Vaccination Disparities During the COVID-19 Pandemic
Lisa A. Grohskopf, MD, MPH; Leandris C. Liburd, PhD, MPH; Robert R. Redfield, MD
free access has active quiz has multimedia has audio
JAMA. 2020;324(11):1029-1030. doi:10.1001/jama.2020.15845
In this Viewpoint, CDC scientists discuss the public health urgency of increasing influenza vaccination uptake early in the 2020-2021 season to ameliorate the threat to patients and hospitals of overlapping outbreaks, and urges clinicians to strongly recommend the vaccine and administer it to patients whenever and wherever possible.
Conversations with Dr Bauchner: Coronavirus Update From the CDC – August 20, 2020

Ethical Considerations for COVID-19 Vaccine Trials in Correctional Facilities

JAMA
September 15, 2020, Vol 324, No. 11, Pages 1019-1116
https://jamanetwork.com/journals/jama/currentissue

 

Ethical Considerations for COVID-19 Vaccine Trials in Correctional Facilities
Emily A. Wang, MD, MAS; Jonathan Zenilman, MD, PhD; Lauren Brinkley-Rubinstein, PhD
free access has active quiz
JAMA. 2020;324(11):1031-1032. doi:10.1001/jama.2020.15589
This Viewpoint discusses the importance of studying coronavirus disease 2019 (COVID-19) vaccine candidates in prisoners, and proposes a framework for considering how to include them safely, ethically, and without coercion in future phase 3 vaccine trials.

Inflow restrictions can prevent epidemics when contact tracing efforts are effective but have limited capacity

Journal of the Royal Society – Interface
September 2020 Volume 17 Issue 170
https://royalsocietypublishing.org/toc/rsif/current

 

Life Sciences–Mathematics interface
Report
Inflow restrictions can prevent epidemics when contact tracing efforts are effective but have limited capacity
Hannes Malmberg and Tom Britton
Published:09 September 2020Article ID:20200351
https://doi.org/10.1098/rsif.2020.0351