WHO & Regional Offices [to 13 Feb 2021]
12 February 2021 Joint News Release
Acute malnutrition threatens half of children under five in Yemen in 2021: UN

11 February 2021 Feature story
WHO Executive Board stresses need for improved response to mental health impact of public health emergencies

10 February 2021 Departmental news
WHO Publishes Quality Criteria for Health National Adaptation Plans

10 February 2021 Joint News Release
In the COVID-19 vaccine race, we either win together or lose together
[See full statement above]

10 February 2021 Statement
ILO joins the Global Action Plan for Healthy Lives and Well-being for All

8 February 2021 Departmental news
France and WHO: a strategic partnership for global health security

8 February 2021 Statement
COVAX Statement on New Variants of SARS-CoV-2
[See full statement above]

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Minister of Health of Niger on keeping COVID-19 cases low 11 February 2021
Niger has witnessed a decline in COVID-19 cases in recent weeks following a surge. Public Health Minister Hon. Botto Ahmet explains what it took to cut back infections and the efforts being strengthened to curb the spread of the virus.
:: Minister of Health of Mauritania speaks about efforts to curb COVID-19 11 February 2021
With COVID-19 cases declining after a second wave of the pandemic in Mauritania saw an acute, fast rise, Minister of Health Minister Hon. Dr Mohamed Nedhirou Hamed shares what it took to limit the spread of the virus and the lessons learned that can be applied to an eventual COVID-19 vaccination.

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
:: New WHO report reveals urgency of confronting tobacco use among women 12-02-2021
:: Getting resources to projects that matter – how WHO/Europe helped countries raise almost US$ 3 million from the Global Fund 11-02-2021
:: Update on COVID-19: cautious optimism 11-02-2021
:: EU and WHO Regional Office for Europe join forces to ensure deployment of COVID-19 vaccines and vaccination in six European countries, their largest collaboration in the European Region to date 11-02-2021
:: Countries strengthen health supply chains with support from UNICEF and WHO 08-02-2021

WHO Eastern Mediterranean Region EMRO
:: Glimmer of hope: COVID-19 vaccines roll out in countries of the Eastern Mediterranean Region
8 February 2021 – While 2020 was a unique and challenging year for the Eastern Mediterranean Region, 2021 has provided a glimmer of hope as vaccines for COVID-19 are rolled out. As part of the COVAX Facility – a global mechanism led by WHO, Gavi and the Coalition for Epidemic Preparedness and Innovations (CEPI), for fair and equitable distribution of vaccines…

WHO Western Pacific Region
No new digest content identified

CDC/ACIP [to 13 Feb 2021]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
Transcript: CDC Update on COVID-19 [Guidance on School Opening in COVID context]]
Friday, February 12, 2021 Audio: https://www.cdc.gov/media/releases/2021/t0212-COVID-19-telebrief.mp3

ACIP Meeting – February 24-25, 2021
Virtual meeting. No registration is required.
Meeting time, 9:30am – 5:30pm EST
Webcast link: http://www.ustream.tv/channel/VWBXKBR8af4
Draft Agenda
Agenda references:
:: Rabies Vaccines
:: Dengue Vaccine
:: Ebola Vaccine
:: Hepatitis Vaccine
:: Pneumococcal Vaccines
:: Zoster Vaccines
:: Influenza Vaccines
:: Cholera Vaccine
:: Orthopoxviruses Vaccines

MMWR News Synopsis Friday, February 12, 2021
:: Advisory Committee on Immunization Practices Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger — United States, 2021
:: Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older — United States, 2021
:: Observed Face Mask Use at Six Universities — United States, September–November 2020 (Early Release February 5, 2021)
:: Decline in COVID-19 Hospitalization Growth Rates Associated with Statewide Mask Mandates — 10 States, March–October 2020 (Early Release February 5, 2021)
:: COVID-19 Vaccination Intent, Perceptions, and Reasons for Not Vaccinating Among Groups Prioritized for Early Vaccination — United States, September and December 2020 (Early Release February 9, 2021)
:: COVID-19 Stats: Percentage of Middle and High School Students Aged 13–21 Years Attending In-Person Classes Who Reported Observing Fellow Students Wearing a Mask All the Time, by School Setting and Activity — United States, October 2020

Coronavirus Disease 2019 (COVID-19)– CDC
Selected Resources
:: Overall US COVID-19 Vaccine Distribution and Administration Update as of Fri, 12 Feb 2021 06:00:00 EST Friday, February 12, 2021
:: COVID-19 Vaccination Intent, Perceptions, and Reasons for Not Vaccinating Among Groups Prioritized for Early Vaccination – United States, September and December 2020 Thursday, February 11, 2021
:: Operational Considerations for Immunization Services during COVID-19 in Non-US Settings Focusing on Low-Middle Income Countries Wednesday, February 10, 202

Africa CDC [to 13 Feb 2021]
http://www.africacdc.org/
News
Statement on the Efficacy of the AstraZeneca COVID-19 Vaccine (ChAdOx1 nCoV-19) against the SARS-CoV-2 Variants
10 February 2021
[See COVID coverage above for detail]

Press Releases
African Union supports response to 12th Ebola Virus Disease outbreak in Democratic Republic of Congo
ADDIS ABABA, ETHIOPIA, 9 FEBRUARY 2021. The African Union Commission, through the Africa Centres for Disease Control and Prevention (Africa CDC), has started discussions with the Government of the Democratic Republic of Congo (DRC) on how to support response to the 12th Ebola Virus Disease (EVD) outbreak in North Kivu. This follows the declaration by the DRC of a new outbreak of EVD on 7 February 2021 in Butembo Area of North Kivu Province after the wife of an EVD survivor tested positive for the virus…

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

National Health Commission of the People’s Republic of China [to 13 Feb 2021]
http://en.nhc.gov.cn/
News
Feb 13: Daily briefing on novel coronavirus cases in China
On Feb 12, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 8 new cases of confirmed infections.

Outcomes of WHO-China joint study in Wuhan released
2021-02-10

China providing vaccine aid to 53 developing countries: FM spokesperson
2021-02-09
[See COVID coverage above for detail]

National Medical Products Administration – PRC [to 13 Feb 2021]
http://english.nmpa.gov.cn/news.html
News
2 Chinese vaccines in advanced stage of assessment: WHO
2021-02-07
Two Chinese vaccines are “in very advanced stage” of the World Health Organization (WHO) Emergency Use Listing Procedure (EUL) assessment, an official from the WHO said on Feb 5.

Organization Announcements

Paul G. Allen Frontiers Group [to 13 Feb 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

BARDA – U.S. Department of HHS [to 13 Feb 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
February 11, 2021
Biden Administration purchases additional doses of COVID-19 vaccines from Pfizer and Moderna
The U.S. Department of Health and Human Services (HHS) and Department of Defense (DOD) have purchased an additional 100 million doses of COVID-19 vaccines from both Pfizer Inc. and Moderna Inc. to help meet demand for COVID-19 vaccines in the United States.
The orders placed today bring the vaccine purchased by the U.S. government from these two companies to a total of 600 million doses, enough to vaccinate 300 million people. Each company is delivering 300 million doses in regular increments through the end of July 2021. Each company will leverage U.S.-based manufacturing capacity to fill, finish and ship vials as the bulk material is produced.
“As the President directed, we are expanding our supply of COVID vaccines to protect people as quickly as possible,” said Acting HHS Secretary Norris Cochran. “These purchases will allow us to accelerate our vaccination efforts to get shots into the arms of the American people. While we rapidly ramp up the pace of vaccinations, I encourage everyone to take actions now to protect themselves and their families: wear a mask, wash your hands often, and practice physical distancing.”…

BMGF – Gates Foundation [to 13 Feb 2021]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

Bill & Melinda Gates Medical Research Institute [to 13 Feb 2021]
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 13 Feb 2021]
https://carb-x.org/
News
No new digest content identified.

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 13 Feb 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
Past weekly editions of Vaccines and Global Health: The Week in Review are available here.

CEPI – Coalition for Epidemic Preparedness Innovations [to 13 Feb 2021]
http://cepi.net/
Latest News
08 Feb 2021
COVAX Statement on New Variants of SARS-CoV-2
The emergence of variants of SARS-CoV-2, the virus that causes COVID-19,  serve as a powerful reminder that viruses by their very nature mutate, and that the scientific response may need to adapt if they are to remain effective against them.
[See COVID above for detail]

DARPA – Defense Advanced Research Projects Agency [to 13 Feb 2021
https://www.darpa.mil/
News
DARPA Program to Offer Near Immediate Doses of Vaccine, Therapeutics for Infectious Diseases
Nucleic acids On-demand Worldwide (NOW) will allow for rapid and distributed manufacturing of nucleic acid-based medical countermeasures
outreach@darpa.mil
2/4/2021
The U.S. military routinely deploys throughout the world where warfighters can potentially be exposed to regional endemic diseases as well as chemical, biological, radiological, or nuclear (CBRN) threats. Rapid access to medical countermeasures (MCMs) against these threats is critical to protect Defense Department (DoD) personnel and local populations; however, manufacturing, stockpiling, and distribution issues remain.

To address these challenges, DARPA has established the Nucleic acids On-demand Worldwide (NOW) program to develop a mobile MCM manufacturing platform to rapidly produce, formulate, and package hundreds of doses of nucleic acid therapeutics in days – rather than months or years. The system promises to provide significant advancement over current cell-based methods, and the resulting product could allow for end-to-end synthesis of Good Manufacturing Practice (GMP) quality material, even in austere environments. The mobile nature of the NOW platform aims to provide immediate threat response anywhere the military operates, mitigate surprise from infectious disease threats, and ensure a resilient, readily accessible nucleic acid MCM manufacturing pipeline.

“This mobile manufacturing system is designed to fit into a CONEX box and taken ‘on the go’ for stabilization and humanitarian missions in addition to traditional military operations,” noted Dr. Amy Jenkins, NOW program manager. “The ability to manufacture therapeutics on-site is a huge advantage in time to produce a product and reduction in logistical burden.”

The NOW program will be organized into three phases. In the 36-month Phase 1, performers will investigate new bio/chemical methods to synthesize nucleic acids (Technical Area 1), and explore downstream purification, analysis, and formulation of newly synthesized material (Technical Area 2). A 12-month Phase 2 will focus on system integration to finalize a contained, end-to-end mobile manufacturing platform. In coordination with the U.S. FDA, the 12-month Phase 3 will focus on a human clinical study that directly compares a NOW-derived product with traditionally-manufactured material. This will demonstrate full platform functionality while producing an MCM targeting a DoD relevant disease indication.

Contracts have been awarded to Moderna, Inc. and GE Research to advance the goals of the program.
“These teams are well positioned to combine the novel approaches to nucleic acid cell free synthesis and the required system engineering approaches for a distributed manufacturing system to ensure the NOW program requirements are met,” noted Jenkins. “Upon program completion, the NOW platform could have important commercial applications by providing increased MCM production and manufacturing during periods of high demand.”

Additional details of the program schedule and metrics are available in the 2019 broad agency announcement at https://beta.sam.gov/opp/012d635117004012a37295c2b10ff78f/view#general.

Duke Global Health Innovation Center [to 13 Feb 2021]
https://dukeghic.org/
Launch and Scale Speedometer
No new digest content identified.

EDCTP [to 13 Feb 2021]
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
11 February 2021
A suitcase-sized laboratory for rapid detection of SARS-COV-2 in Africa
The PCR test is the most accurate tool to identify SARS-CoV-2, the virus causing COVID-19. However, valid results are often available only after days. Moreover, the laboratory must be well equipped, have trained personnel and sufficient financial resources. In cooperation with several African universities, a study led by virologist Dr Ahmed Abd El Wahed, Leipzig University, found that a small, mobile laboratory fitting in a suitcase delivers test results that are almost as good as a PCR test and are delivered almost in real-time. EDCTP supported the clinical evaluation with a COVID-19 Emergency grant of €500,000…

Emory Vaccine Center [to 13 Feb 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Commission [to 13 Feb 2021]
http://europa.eu/rapid/search-result.htm?query=18&locale=en&page=1
Press release 11 February 2021
New EU programme to support readiness for vaccination efforts in Eastern Partnership countries with WHO
Today, the EU in partnership with the World Health Organisation (WHO) launched a new regional programme worth over €40 million to provide critical assistance to ensure local readiness and preparedness for safe and effective vaccination of the population in the six Eastern Partnership countries: Armenia, Azerbaijan, Belarus, Georgia, the Republic of Moldova and Ukraine.

Speech 10 February 2021
Remarks by Commissioner Stella Kyriakides in the Plenary of the European Parliament on the EU Vaccine Strategy
Remarks by Commissioner Stella Kyriakides in the Plenary of the European Parliament on the EU Vaccine Strategy

Speech 10 February 2021
Speech by President von der Leyen at the European Parliament Plenary on the state of play of the EU’s COVID-19 Vaccination Strategy
The President of the Commission, Ursula von der Leyen, gave a speech at the European Parliament Plenary debate on the state of play of the EU’s COVID-19 Vaccination Strategy.

European Medicines Agency [to 13 Feb 2021]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021
PRAC, Last updated: 12/02/2021

News: EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
Last updated: 12/02/2021
[See COVID coverage above for detail]

News: EMA preparing guidance to tackle COVID-19 variants
Last updated: 10/02/2021
[See COVID coverage above for detail]

News: Clarification on Sputnik V vaccine in the EU approval process
Last updated: 10/02/2021
[See COVID coverage above for detail]

News: International regulators working together to enhance collaboration on COVID-19 observational research
Last updated: 08/02/2021
[See COVID coverage above for detail]

European Vaccine Initiative [to 13 Feb 2021]
http://www.euvaccine.eu/
Latest News
EVI
11 Feb 2021
International Day of Women and Girls in Science 2021

FDA [to 13 Feb 2021]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
:: February 12, 2021 – Coronavirus (COVID-19) Update: February 12, 2021
…This week, the FDA posted the webpage, COVID-19 Vaccine Safety Surveillance, which provides an overview of our active and passive systems used to monitor the safety of authorized COVID-19 vaccines. The FDA’s Center for Biologics Evaluation and Research is conducting these surveillance efforts in collaboration with the Centers for Disease Control and Prevention, the Center for Medicare and Medicaid Services, the Department of Veterans Affairs, and other academic and large non-government healthcare data systems…

:: February 9, 2021 – Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

:: February 9, 2021 – Coronavirus (COVID-19) Update: February 9, 2021

FDA – COVID-19 Vaccines [to 13 Feb 2021]
www.fda.gov/covid19vaccines
News and Updates; Upcoming Events
02/12/2021
Coronavirus (COVID-19) Update
FDA issued an emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 in adults and pediatric patients and also revised its guidance, Investigational COVID-19 Convalescent Plasma.

Fondation Merieux [to 13 Feb 2021]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation co-organized event
MERACON: Returning to rabies elimination in 2021 webinar
February 26, 2021 – 9:00am -12:00pm (CET)
Context
The COVID-19 pandemic has hampered global travel and has placed a strain on public health systems globally. Because of this, many rabies activities were postponed or cancelled in 2020. Similarly, the planned in-person regional MERACON workshop that was initially scheduled for mid-2020 was postponed to 2021. As a means to continue remote support, foster collaboration and continue to drive progress towards rabies elimination in the MERACON countries, the MERACON steering committee has scheduled a digital meeting in webinar format. This webinar will act as a precursor to a more detailed workshop later in the year which we hope to host in-person (COVID-19 restrictions permitting).

Gavi [to 13 Feb 2021]
https://www.gavi.org/
News Releases
COVAX Statement on New Variants of SARS-CoV-2
8 February 2021
[See COVID above for detail]

GHIT Fund [to 13 Feb 2021]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
Press Releases
No new digest content identified.

Global Fund [to 13 Feb 2021]
https://www.theglobalfund.org/en/news/
News & Stories
Safely Reopening Requires Testing, Tracing and Isolation, Not Just Vaccines
11 February 2021
by Peter Sands, Executive Director of the Global Fund & Achim Steiner, UNDP Administrator

Protecting the most vulnerable in Latin America and the Caribbean during times of COVID-19
11 February 2021
Latin America and the Caribbean have made significant progress in the fight against HIV, tuberculosis and malaria in the last few decades. But the COVID-19 pandemic has hit the region hard, and its indirect effects could allow infectious diseases to resurge.

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 13 Feb 2021]
https://www.glopid-r.org/news/
News
GloPID-R and partners UKCDR & ISARIC further COVID-19 response
08/02/2021
… The public website UKCDR–GloPID-R COVID CIRCLE Researcher Coordination Platform was launched to facilitate information sharing on COVID-19 research and bring together the global research community working on COVID-19 research, in and for low resource settings.
Key features of the platform are:
:: COVID-19 Resource hub: including the UKCDR & GloPID-R COVID-19 Research Projects Tracker, COVID-19 research reports, papers, guidance, tools and webinars collected from key organisations
:: Map of global and regional networks relevant to epidemics research
:: COVID-19 events from around the world including webinars, workshops and more…

Hilleman Laboratories [to 13 Feb 2021]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 13 Feb 2021]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
HVP COVID REPORT – Issue 26
One Shot or Two?
Akiko Iwasaki, Ph.D.
Professor of Immunobiology and Molecular, Cellular, and Developmental Biology
Yale School of Medicine
In response to the still limited supply of COVID-19 vaccines, governments, health departments, and scientists are evaluating various ways to stretch existing doses and vaccinate more of the global population as quickly as possible. This effort is particularly urgent given the concern over SARS-CoV-2 variants that are increasingly prevalent throughout the world. In some cases, this has meant delaying the second vaccine dose. But for individuals who have already had COVID, data suggest it may be possible to forego the second dose altogether. HVP Editor Kristen Jill Abboud recently spoke with Akiko Iwasaki, Professor of Immunobiology and Molecular, Cellular, and Developmental Biology at Yale School of Medicine, about establishing effective immunity in individuals who have recovered from COVID-19.

IAVI [to 13 Feb 2021]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
Features
February 12, 2021
Explainer videos: Understanding concepts of HIV vaccine development

February 9, 2021
Prevention revolution or miles away from our targets? A look back at HIV Research for Prevention

February 8, 2021
How can COVID-19 pave the way for global access pathways for monoclonal antibodies?

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
Press Releases/Announcements
No new digest content identified.

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

IFRC [to 13 Feb 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.

Institut Pasteur [to 13 Feb 2021]
https://www.pasteur.fr/en/press-area
Press release 12.02.2021
Heat islands and lack of running water promote dengue fever in Delhi, India
What if more inclusive urban planning for poor populations was key to fighting dengue fever? This is what researchers…

Press Info 12.02.2021
Comment: The tortuous path to ending the Covid-19 pandemic
The COVID-19 pandemic has devastated health-care systems, shut down schools and communities, and plunged the world into an economic recession. While 2020 was a challenging year, 2021 looks to be difficult with the emergence of multiple variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The race to vaccinate the world will need to respond to the pathogen’s constant evolution to evade immunity. What marks the path to the end of this pandemic?
Read the full comment in The Lancet – published on February 11, 2021

IRC International Rescue Committee [to 13 Feb 2021]
http://www.rescue.org/press-release-index
Media highlights [Selected]
No new digest content identified.

IVAC [to 13 Feb 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

IVI [to 13 Feb 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

JEE Alliance [to 13 Feb 2021]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

Johns Hopkins Center for Health Security [to 13 Feb 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
Johns Hopkins Center for Health Security Launches a New Comprehensive Toolkit on COVID-19 Testing and Testing Services
February 11, 2021

New Report: Equity in Vaccination: A Plan to Work with Communities of Color Toward COVID-19 Recovery and Beyond
February 9, 2021

MSF/Médecins Sans Frontières [to 13 Feb 2021]
http://www.msf.org/
Latest [Selected Announcements]
Afghanistan
Keeping an eye on COVID-19 cases in Herat, Afghanistan
Project Update 12 Feb 2021
Due to an increase in the number of people with severe COVID-19 in Herat, western Afghanistan, the Médecins Sans Frontières (MSF) COVID-19 treatment centre in Gazer Ga reopened on 2 December 2020…

National Vaccine Program Office – U.S. HHS [to 13 Feb 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

NIH [to 13 Feb 2021]
http://www.nih.gov/news-events/news-releases
News Releases
Researchers propose that humidity from masks may lessen severity of COVID-19
February 12, 2021 — NIH study compares how different face masks affect humidity inside the mask.

Study Identifies Risk Factors for Elevated Anxiety in Young Adults During COVID-19 Pandemic
February 12, 2021 — Findings on impact of childhood temperament could help with anxiety prevention efforts.

NIH experts discuss SARS-CoV-2 viral variants
February 12, 2021 — Editorial emphasizes need for global response.

Four potential COVID-19 therapeutics enter Phase 2/3 testing in NIH ACTIV-2 trial
February 12, 2021 — The added sub-studies will test four interventions for safety and efficacy.

NIH calls for greater inclusion of pregnant and lactating people in COVID-19 vaccine research
February 10, 2021 — Longstanding obstacles to include pregnant and lactating people in clinical research have led to this population now deciding whether or not to receive a SARS-CoV-2 vaccine without the benefit of scientific evidence, writes Diana W. Bianchi, M.D., director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health, and colleagues. Their viewpoint article appears online in JAMA….

Clinical trial in hospitalized COVID-19 patients evaluates long-acting antibody therapy
February 8, 2021 — NIH trial has begun enrolling participants.

PATH [to 13 Feb 2021]
https://www.path.org/media-center/
Press Release
No new digest content identified.

Sabin Vaccine Institute [to 13 Feb 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
Learning to Prevent the Next Pandemic: VaxHunt Game Earns STEM.org Educational Trustmark
Monday, February 8, 2021

UNAIDS [to 13 Feb 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
12 February 2021
People living with HIV in Kyrgyzstan have won the right to adopt

10 February 2021
Making a mark on the COVID-19 pandemic: joint efforts to meet the needs of young key populations in Asia and the Pacific

9 February 2021
How was a COVID-19 vaccine found so quickly?

8 February 2021
Provision of services for domestic violence uneven

UNHCR Office of the United Nations High Commissioner for Refugees [to 13 Feb 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected Announcements
UNHCR and IOM welcome Colombia’s decision to regularize Venezuelan refugees and migrants
UNHCR–IOM Joint Press Release
8 Feb 2021
BOGOTA/GENEVA – UNHCR, the UN Refugee Agency and IOM, the International Organization for Migration, today praised Colombia’s initiative to provide ten-year temporary protection status to Venezuelans in the country…
…The Temporary Protection Status will also provide access to basic services including the national health system and COVID-19 vaccination plans…

UNICEF [to 13 Feb 2021]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Press release 02/07/2021
UNICEF deploys staff, medical equipment and supplies in response to new Ebola case in eastern DRC
UNICEF working with Government and partners in North Kivu province following announcement by the Ministry of Health of the death of a 42 year-old-mother

Unitaid [to 13 Feb 2021]
https://unitaid.org/
Featured News
No new digest content identified.

Vaccination Acceptance Research Network (VARN) [to 13 Feb 2021]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

Vaccine Confidence Project [to 13 Feb 2021]
http://www.vaccineconfidence.org/
News, Research and Reports
No new digest content identified.

Vaccine Education Center – Children’s Hospital of Philadelphia [to 13 Feb 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

Wellcome Trust [to 13 Feb 2021]
https://wellcome.ac.uk/news
News
Opinion
Why we should involve more young people in health research
It is crucial to empower and support young people to shape health research, and this is why.
Anita Krishnamurthi, Head of Education and Learning
11 February 2021

Opinion
Why we need a scientific approach to mental health at work
With businesses looking to support the mental health of their staff more than ever, Wellcome is urging them to take a science-based approach. Miranda Wolpert shares what we’ve learned so far about what works for supporting mental health at work.
Miranda Wolpert, Head of Mental Health
9 February 2021

The Wistar Institute [to 13 Feb 2021]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

WFPHA: World Federation of Public Health Associations [to 13 Feb 2021]
https://www.wfpha.org/
Latest News
No new digest content identified.

World Organisation for Animal Health (OIE) [to 13 Feb 2021]
https://www.oie.int/en/for-the-media/press-releases/2021/
Press Releases
No new digest content identified.

::::::

ARM [Alliance for Regenerative Medicine] [to 13 Feb 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Press Releases
No new digest content identified.

BIO [to 13 Feb 2021]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

DCVMN – Developing Country Vaccine Manufacturers Network [to 13 Feb 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

ICBA – International Council of Biotechnology Associations [to 13 Feb 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

IFPMA [to 13 Feb 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

PhRMA [to 13 Feb 2021]
http://www.phrma.org/
Selected Press Releases, Statements
Lessons learned from COVID-19: The way we develop new medicines is changing
February 10, 2021
Richard Moscicki, M.D. serves as executive vice president, Science and Regulatory Advocacy and chief medical officer at PhRMA.
Early on in the pandemic, social distancing measures forced a rapid and widespread adoption of digital technologies to support safer communication between patients and providers. Researchers from Health Affairs studying data have found “during the pandemic, 30.1% of all visits were provided via telemedicine” and that weekly visits occurring for telemedicine rose exponentially from pre-COVID-19 levels.
Blog Post

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

AMA Journal of Ethics
Volume 23, Number 2: E83-211 Feb 2021
https://journalofethics.ama-assn.org/issue/racial-and-ethnic-health-equity-us-part-1

Racial and Ethnic Health Equity in the US: Part 1
Health equity is defined by the World Health Organization as the “absence of unfair and avoidable or remediable differences in health among social groups.” Domestically and globally, health inequity is not a historical accident. Inequity today is not unfortunate—that is, not a product of a mere turn of the proverbial cosmic wheel—but unjust—that is, generated by colonial, White supremacist policies and practices structured and maintained over time, forged to persist in hierarchies that serve some of us, our ancestors, and our descendants well and some of us, our ancestors, and our descendants ill. This first of a 2-part theme issue focuses specifically on racial and ethnic inequity in morbidity, mortality, and access to services that are endemic to American life. We investigate health inequity as a product of transgenerational patterns of oppression that must be remediated by all of us compassionately and more deliberately and quickly than they were created.

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 13 Feb 2021)

Who should be prioritized for COVID-19 vaccination in China? A descriptive study
All countries are facing decisions about which population groups to prioritize for access to COVID-19 vaccination after the first vaccine products have been licensed, at which time supply shortages are inevita…
Authors: Juan Yang, Wen Zheng, Huilin Shi, Xuemei Yan, Kaige Dong, Qian You, Guangjie Zhong, Hui Gong, Zhiyuan Chen, Mark Jit, Cecile Viboud, Marco Ajelli and Hongjie Yu
Citation: BMC Medicine 2021 19:45
Content type: Research article
Published on: 10 February 2021

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

Research
Characterization of immunization secondary analyses using demographic and health surveys (DHS) and multiple indicator cluster surveys (MICS), 2006–2018
Infant immunization coverage worldwide has plateaued at about 85%. Using existing survey data to conduct analyses beyond estimating coverage may help immunization programmes better tailor strategies to reach u…
Authors: Yue Huang and M. Carolina Danovaro-Holliday
Citation: BMC Public Health 2021 21:351
Content type: Research article
Published on: 12 February 2021

Bulletin of the World Health Organization
Volume 99, Number 2, February 2021, 77-168
https://www.who.int/bulletin/volumes/99/2/en/

EDITORIALS
COVID-19 response and mitigation: a call for action
— Viroj Tangcharoensathien, Poonam Singh & Anne Mills
http://dx.doi.org/10.2471/BLT.20.285322

Bulletin of the World Health Organization
Volume 99, Number 2, February 2021, 77-168
https://www.who.int/bulletin/volumes/99/2/en/

RESEARCH
Community perspectives on the COVID-19 response, Zimbabwe
— Constance RS Mackworth-Young, Rudo Chingono, Constancia Mavodza, Grace McHugh, Mandikudza Tembo, Chido Dziva Chikwari, Helen A Weiss, Simbarashe Rusakaniko, Sithembile Ruzario, Sarah Bernays & Rashida A Ferrand
http://dx.doi.org/10.2471/BLT.20.260224

Bulletin of the World Health Organization
Volume 99, Number 2, February 2021, 77-168
https://www.who.int/bulletin/volumes/99/2/en/

Government trust, perceptions of COVID-19 and behaviour change: cohort surveys, Singapore
— Vanessa W Lim, Rachel L Lim, Yi Roe Tan, Alexius SE Soh, Mei Xuan Tan, Norhudah Bte Othman, Sue Borame Dickens, Tun-Linn Thein, May O Lwin, Rick Twee-Hee Ong, Yee-Sin Leo, Vernon J Lee & Mark IC Chen
http://dx.doi.org/10.2471/BLT.20.269142

Bulletin of the World Health Organization
Volume 99, Number 2, February 2021, 77-168
https://www.who.int/bulletin/volumes/99/2/en/

Economic burden of COVID-19, China, January–March, 2020: a cost-of-illness study
— Huajie Jin, Haiyin Wang, Xiao Li, Weiwei Zheng, Shanke Ye, Sheng Zhang, Jiahui Zhou & Mark Pennington
http://dx.doi.org/10.2471/BLT.20.267112

Bulletin of the World Health Organization
Volume 99, Number 2, February 2021, 77-168
https://www.who.int/bulletin/volumes/99/2/en/

A survey of national ethics and bioethics committees
— Johannes Köhler, Andreas Alois Reis & Abha Saxena
http://dx.doi.org/10.2471/BLT.19.243907
Abstract
Objective
To assess the current state of national ethics committees and the challenges they face.
Methods
We surveyed national ethics committees between 30 January and 21 February 2018.
Findings
In total, representatives of 87 of 146 national ethics committees (59.6%) participated. The 84 countries covered were in all World Bank income categories and all World Health Organization regions. Many national ethics committees lack resources and face challenges in several domains, like independence, funding or efficacy. Only 40.2% (35/87) of committees expressed no concerns about independence. Almost a quarter (21/87) of committees did not make any ethics recommendations to their governments in 2017, and the median number of reports, opinions or recommendations issued was only two per committee Seventy-two (82.7%) national ethics committees included a philosopher or a bioethicist.
Conclusion
National ethics (or bioethics) committees provide recommendations and guidance to governments and the public, thereby ensuring that public policies are informed by ethical concerns. Although the task is seemingly straightforward, implementation reveals numerous difficulties. Particularly in times of great uncertainty, such as during the current coronavirus disease 2019 pandemic, governments would be well advised to base their actions not only on technical considerations but also on the ethical guidance provided by a national ethics committee. We found that, if the advice of national ethics committees is to matter, they must be legally mandated, independent, diverse in membership, transparent and sufficiently funded to be effective and visible.

Bulletin of the World Health Organization
Volume 99, Number 2, February 2021, 77-168
https://www.who.int/bulletin/volumes/99/2/en/

POLICY & PRACTICE
Immunity certification for COVID-19: ethical considerations
— Teck Chuan Voo, Andreas A Reis, Beatriz Thomé, Calvin WL Ho, Clarence C Tam, Cassandra Kelly-Cirino, Ezekiel Emanuel, Juan P Beca, Katherine Littler, Maxwell J Smith, Michael Parker, Nancy Kass, Nina Gobat, Ruipeng Lei, Ross Upshur, Samia Hurst & Sody Munsaka
http://dx.doi.org/10.2471/BLT.20.280701
Abstract
Restrictive measures imposed because of the coronavirus disease 2019 (COVID-19) pandemic have resulted in severe social, economic and health effects. Some countries have considered the use of immunity certification as a strategy to relax these measures for people who have recovered from the infection by issuing these individuals a document, commonly called an immunity passport. This document certifies them as having protective immunity against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19. The World Health Organization has advised against the implementation of immunity certification at present because of uncertainty about whether long-term immunity truly exists for those who have recovered from COVID-19 and concerns over the reliability of the proposed serological test method for determining immunity. Immunity certification can only be considered if scientific thresholds for assuring immunity are met, whether based on antibodies or other criteria. However, even if immunity certification became well supported by science, it has many ethical issues in terms of different restrictions on individual liberties and its implementation process. We examine the main considerations for the ethical acceptability of immunity certification to exempt individuals from restrictive measures during the COVID-19 pandemic. As well as needing to meet robust scientific criteria, the ethical acceptability of immunity certification depends on its uses and policy objectives and the measures in place to reduce potential harms, and prevent disproportionate burdens on non-certified individuals and violation of individual liberties and rights.

Bulletin of the World Health Organization
Volume 99, Number 2, February 2021, 77-168
https://www.who.int/bulletin/volumes/99/2/en/

PERSPECTIVES
Present value of future health data: ethics of data collection and use
— Ann Dulhanty
http://dx.doi.org/10.2471/BLT.19.237248

Clinical Trials
Volume 18 Issue 1, February 2021
https://journals.sagepub.com/toc/ctja/18/1

Articles
A survey of the feasibility of developing osteoporosis clinical trials in Duchenne muscular dystrophy: Survey of the opinion of young people with Duchenne muscular dystrophy, families and clinicians
Sze Choong Wong, Shuko Joseph, Nadia Capaldi, Marina Di Marco, Jennifer Dunne, Michela Guglieri, Iain Horrocks, Volker Straub, S Faisal Ahmed, the UK NorthStar Clinical Network
First Published October 4, 2020; pp. 39–50Abstract
Abstract
Background/aims
Given the extent of osteoporosis in people with Duchenne muscular dystrophy treated with glucocorticoids and the limited evidence of bone-protective therapies, clinical trials are needed. We conducted surveys to obtain the opinion of young people with Duchenne muscular dystrophy, parents/guardians and neuromuscular clinicians on the feasibility of osteoporosis clinical trials in this population.
Methods
Online surveys were sent to three groups: (a) people with a confirmed diagnosis of Duchenne muscular dystrophy (≥14 years), (b) parents and guardians and (c) neuromuscular clinicians in the UK NorthStar Clinical Network. Surveys (a) and (b) were distributed via the UK Duchenne muscular dystrophy Registry.
Results
Survey respondents included 52 people with Duchenne muscular dystrophy with a median age of 17 years (range: 14, 40) and 183 parents/guardians. Fourteen out of 23 (61%) NorthStar centres responded. Of the 52 people with Duchenne muscular dystrophy, 13 (25%) were very concerned about their bone health and 21 (40%) were slightly concerned. Of the 183 parents/guardians, 75 (41%) were very concerned about their son’s bone health and 90 (49%) were slightly concerned. Fractures and quality of life were the top two main outcome measures identified by people with Duchenne muscular dystrophy. Fractures and bone density were the top two main outcome measures identified by parents/guardians and neuromuscular clinicians. Thirty percent of people with Duchenne muscular dystrophy and 40% of parents/guardians would not take part if an osteoporosis trial involved a placebo that was administered parenterally. Only 2 of the 14 NorthStar centres (14%) would enrol people with Duchenne muscular dystrophy if a parenteral placebo was used in an osteoporosis trial in Duchenne muscular dystrophy.
Conclusion
There is great awareness of bone health and the need for bone-protective trials among people with Duchenne muscular dystrophy and their carers. However, a proportion of people with Duchenne muscular dystrophy and parents are reluctant to participate in a placebo-controlled osteoporosis trial that included a parenteral therapy. A larger proportion of health care experts are unwilling to enrol their patients in such a trial. Our finding is relevant for the design of bone-protective studies in Duchenne muscular dystrophy.

Clinical Trials
Volume 18 Issue 1, February 2021
https://journals.sagepub.com/toc/ctja/18/1

Ethics
Details of risk–benefit communication in informed consent documents for phase I/II trials
Hannes Kahrass, Sabine Bossert, Christopher Schürmann, Daniel Strech
First Published November 24, 2020; pp. 71–80
Abstract
Background:
Informed consent documents for clinical studies should disclose all reasonably foreseeable risks and benefits. Little guidance exists on how to navigate the complexities of risk–benefit communication, especially in early clinical research. Practice-oriented development of such guidance should be informed by evidence on what and how details of risks and benefits are currently communicated.
Method:
We surveyed the responsible parties of phase I/II trials registered in ClinicalTrials.gov that started 2007 or later and completed between 2012 and 2016 to sample informed consent documents from a broad spectrum of early phase clinical trials. Based on an assessment matrix, we qualitatively and quantitatively assessed the informed consent documents for details of risk–benefit communication.
Results:
The risk–benefit communication in the 172 informed consent documents differed substantially in several regards. The outcome, extent, and likelihood of health risks, for example, were described in 83%, 32%, and 63% of the informed consent documents. Only 45% of informed consent documents specified the outcome of mentioned health benefits, and the extent and likelihood of health benefits were never specified. From those informed consent documents reporting risk likelihoods, only 57% added frequency numbers to words such as “common” or “rare,” and even in these cases, we found strong variations for presented frequency ranges. Substantial heterogeneity also exists for how informed consent documents communicate other risk and benefit types and related safeguards.
Conclusion:
Our study points to several shortcomings and heterogeneities in how informed consent documents communicate risks and benefits to potential research participants. Health risks, for example, should be specified with frequency numbers, and health benefits should be specified at least by mentioning their outcomes. Further demand for research and policy development is needed to harmonize risk–benefit communication and to clarify ways to specify the likelihood of health benefits.

Conflict and Health
http://www.conflictandhealth.com/
[Accessed 13 Feb 2021]

The effect of the ongoing civil strife on key immunisation outcomes in the North West and South West regions of Cameroon
Civil strife has long been recognized as a significant barrier in the fight against vaccine preventable diseases in several parts of the world. However, little is known about the impact of the ongoing civil strife on the immunisation system in the Northwest (NW) and Southwest (SW) regions of Cameroon, which erupted in late 2016. In this paper, we assessed the effect of the conflict on key immunisation outcomes in the North West and South West regions of Cameroon.
Authors: Yauba Saidu, Marius Vouking, Andreas Ateke Njoh, Hassan Ben Bachire, Calvin Tonga, Roberts Mofor, Christain Bayiha, Leonard Ewane, Chebo Cornelius, Ndi Daniel Daddy Mbida, Messang Blandine Abizou, Victor Mbome Njie and Divine Nzuobontane
Content type: Research
10 February 2021

Contemporary Clinical Trials
Volume 100 January 2021
https://www.sciencedirect.com/journal/contemporary-clinical-trials/vol/100/suppl/C

Research article Abstract only
Using digital technologies in clinical trials: Current and future applications
Carmen Rosa, Lisa A. Marsch, Erin L. Winstanley, Meg Brunner, Aimee N.C. Campbell
Article 106219
Abstract
In 2015, we provided an overview of the use of digital technologies in clinical trials, both as a methodological tool and as a mechanism to deliver interventions. At that time, there was limited guidance and limited use of digital technologies in clinical research. However, since then smartphones have become ubiquitous and digital health technologies have exploded. This paper provides an update to our earlier publication and an overview of how technology has been used in the past five years in clinical trials, providing examples with varying levels of technological integration and across different health conditions. Digital technology integration ranges from the incorporation of artificial intelligence in diagnostic devices to the use of real-world data (e.g., electronic health records) for study recruitment. Clinical trials can now be conducted entirely virtually, eliminating the need for in-person interaction. Much of the published research demonstrates how digital approaches can improve the design and implementation of clinical trials. While challenges remain, progress over the last five years is encouraging, and barriers can be overcome with careful planning.

Contemporary Clinical Trials
Volume 100 January 2021
https://www.sciencedirect.com/journal/contemporary-clinical-trials/vol/100/suppl/C

Research article Full text access
Innovative trial designs and analyses for vaccine clinical development
Mengya Liu, Qing Li, Jianchang Lin, Yunzhi Lin, Elaine Hoffman
Article 106225
Abstract
In the past decades, the world has experienced several major virus outbreaks, e.g. West African Ebola outbreak, Zika virus in South America and most recently global coronavirus (COVID-19) pandemic. Many vaccines have been developed to prevent a variety of infectious diseases successfully. However, several infections have not been preventable so far, like COVID-19, which induces an immediate urgent need for effective vaccines. These emerging infectious diseases often pose unprecedent challenges for the global heath community as well as the conventional vaccine development paradigm. With a long and costly traditional vaccine development process, there are extensive needs in innovative vaccine trial designs and analyses, which aim to design more efficient vaccines trials. Featured with reduced development timeline, less resource consuming or improved estimate for the endpoints of interests, these more efficient trials bring effective medicine to target population in a faster and less costly way. In this paper, we will review a few vaccine trials equipped with adaptive design features, Bayesian designs that accommodate historical data borrowing, the master protocol strategy emerging during COVID-19 vaccine development, Real-World-Data (RWD) embedded trials and the correlate of protection framework and relevant research works. We will also discuss some statistical methodologies that improve the vaccine efficacy, safety and immunogenicity analyses. Innovative clinical trial designs and analyses, together with advanced research technologies and deeper understanding of the human immune system, are paving the way for the efficient development of new vaccines in the future.

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 13 Feb 2021]

Research
Who suffered most after deaths due to COVID-19? Prevalence and correlates of prolonged grief disorder in COVID-19 related bereaved adults
Authors: Suqin Tang and Zhendong Xiang
11 February 2021

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

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

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

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

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 17, Issue 1, 2021
https://www.tandfonline.com/toc/khvi20/current

Research Paper
Article
The intentions to get vaccinated against influenza and actual vaccine uptake among diabetic patients in Ningbo, China: identifying motivators and barriers
Lixia Ye, Ting Fang, Jun Cui, Guanghui Zhu, Rui Ma, Yexiang Sun, Pingping Li, Hui Li, Hongjun Dong & Guozhang Xu
Pages: 106-118
Published online: 27 May 2020

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 17, Issue 1, 2021
https://www.tandfonline.com/toc/khvi20/current

Article
Analysis of protective immune responses to seasonal influenza vaccination in HIV-infected individuals
Ying Xia, Fuli Mi, Guoqiang Du & Shenghui Qin
Pages: 124-132
Published online: 15 May 2020

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 17, Issue 1, 2021
https://www.tandfonline.com/toc/khvi20/current

Article
Incomplete vaccination and associated factors among children aged 12–23 months in South Africa: an analysis of the South African demographic and health survey 2016
Duduzile Ndwandwe, Chukwudi A. Nnaji, Thandiwe Mashunye, Olalekan A. Uthman & Charles S. Wiysonge
Pages: 247-254
Published online: 23 Jul 2020

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 17, Issue 1, 2021
https://www.tandfonline.com/toc/khvi20/current

Article
Chinese mothers’ intention to vaccinate daughters against human papillomavirus (HPV), and their vaccine preferences: a study in Fujian Province
Yulan Lin, Zhitai Su, Fulian Chen, Qinjian Zhao, Gregory D. Zimet, Haridah Alias, Shuqiong He, Zhijian Hu & Li Ping Wong
Pages: 304-315
Published online: 13 May 2020

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 17, Issue 1, 2021
https://www.tandfonline.com/toc/khvi20/current

Review
Control of vaccine preventable diseases in Australian infants: reviewing a decade of experience with DTPa-HBV-IPV/Hib vaccine
Julianne Bayliss, Michael Nissen, Damita Prakash, Peter Richmond, Kyu-Bin Oh & Terry Nolan
Pages: 176-190
Published online: 23 Jun 2020

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 17, Issue 1, 2021
https://www.tandfonline.com/toc/khvi20/current

Close the gap for routine mumps vaccination in Japan
Taito Kitano
Pages: 205-210
Published online: 12 Jun 2020

JAMA
February 9, 2021, Vol 325, No. 6, Pages 507-596
https://jamanetwork.com/journals/jama/currentissue

Viewpoint
Health Policy
The COVID-19 Pandemic as an Opportunity to Ensure a More Successful Future for Science and Public Health
K. M. Venkat Narayan, MD, MSc; James W. Curran, MD, MPH; William H. Foege, MD, MPH
free access has active quiz
JAMA. 2021;325(6):525-526. doi:10.1001/jama.2020.23479
This Viewpoint suggests that the COVID-19 pandemic provides an opportunity to build trust in science and update federal agencies to improve public health and poses questions and offers recommendations for consideration.

JAMA
February 9, 2021, Vol 325, No. 6, Pages 507-596
https://jamanetwork.com/journals/jama/currentissue

Genetic Variants of SARS-CoV-2—What Do They Mean?
Adam S. Lauring, MD, PhD; Emma B. Hodcroft, PhD
free access has active quiz has multimedia has audio
JAMA. 2021;325(6):529-531. doi:10.1001/jama.2020.27124
This Viewpoint discusses emerging genetic variants of SARS-CoV-2, including new “UK” and “mink” variants and the significance of the new variants to coronavirus transmissibility, spread, virulence, and efforts to vaccinate the population against COVID-19.

JAMA
February 9, 2021, Vol 325, No. 6, Pages 507-596
https://jamanetwork.com/journals/jama/currentissue

Mandating COVID-19 Vaccines
Lawrence O. Gostin, JD; Daniel A. Salmon, MPH, PhD; Heidi J. Larson, PhD
free access has active quiz has audio
JAMA. 2021;325(6):532-533. doi:10.1001/jama.2020.26553
This Viewpoint discusses whether US states, businesses, health care facilities, and schools and universities can mandate vaccination against coronavirus as a condition of employment or service.
…Mandating COVID-19 vaccines under an EUA is legally and ethically problematic. The act authorizing the FDA to issue EUAs requires the secretary of the Department of Health and Human Services (HHS) to specify whether individuals may refuse the vaccine and the consequences for refusal. Vaccine mandates are unjustified because an EUA requires less safety and efficacy data than full Biologics License Application (BLA) approval. Individuals would also likely distrust vaccine mandates under emergency use, viewing it as ongoing medical research…

Conversations with Dr Bauchner: Mandating COVID-19 Vaccines—Ethical and Legal Considerations

JAMA
February 9, 2021, Vol 325, No. 6, Pages 507-596
https://jamanetwork.com/journals/jama/currentissue

Problems With Paying People to Be Vaccinated Against COVID-19
Emily A. Largent, JD, PhD, RN; Franklin G. Miller, PhD
free access has active quiz
JAMA. 2021;325(6):534-535. doi:10.1001/jama.2020.27121
This Viewpoint describes features of 2 proposals to pay US residents to be vaccinated against COVID-19 and proposes ethical and practical complications of the plans, arguing that they are morally suspect, likely unnecessary, and may be counterproductive.

JAMA Network
COVID-19 Update February 13, 2021

These articles on COVID-19 were published across the JAMA Network in the last week.

The Lancet
Feb 13, 2021 Volume 397 Number 10274 p555-640, e6
https://www.thelancet.com/journals/lancet/issue/current

Editorial
Improving prisoner health for stronger public health
The Lancet

The Lancet
Feb 13, 2021 Volume 397 Number 10274 p555-640, e6
https://www.thelancet.com/journals/lancet/issue/current

Comment
Urgent needs of low-income and middle-income countries for COVID-19 vaccines and therapeutics
Lancet Commission on COVID-19 Vaccines and Therapeutics Task Force Members
WHO and partners have learnt from the mis-steps in the response to the 2009 H1N1 influenza pandemic¹ and established the Access to COVID-19 Tools (ACT) Accelerator to promote equitable access to vaccines, therapeutics, and diagnostics.² However, many high-income countries already have bilateral agreements with manufacturers of COVID-19 vaccines.³ The COVAX Facility of the ACT Accelerator has agreements to access 2 billion doses of WHO pre-qualified vaccines during 2021, but this represents only 20% of the vaccine needs of participating countries.⁴ Most low-income and middle-income countries (LMICs) face difficulties in accessing and delivering vaccines and therapeutics for COVID-19 to their populations.⁵ COVAX will require decisive action by Gavi, the Vaccine Alliance, WHO, and the Coalition for Epidemic Preparedness Innovations (CEPI), supported by the countries they serve and with financing for vaccine purchasing, to ensure people worldwide have equitable access to COVID-19 vaccines.⁶,  ⁷,  ⁸

For 80% of the populations in LMICs that will not benefit from COVAX-provided COVID-19 vaccines, finances for purchase or donations are needed. Government measures in response to COVID-19 and the broader global financial situation have led to increasing fiscal imbalances of heavily indebted countries.⁹ Multinational agencies, financial institutions, and wealthier countries should consider measures that could provide relief to indebted LMICs. The World Bank, the International Monetary Fund, and others need to lead an international initiative to mobilise support for LMICs in need.

Many LMICs do not have an established platform for vaccinating their adult populations.¹⁰ Although it is feasible to deliver COVID-19 vaccines to health-care and other front-line essential workers, in some LMICs it will be difficult to effectively reach and vaccinate with two doses all elderly populations and individuals with co-morbidities, given insufficient mechanisms to identify such groups. Governments and technical leaders will need to use transparent, accountable, and unbiased processes when they make and explain evidence-based vaccine prioritisation decisions, while also building confidence in COVID-19 vaccines and engaging with all the stakeholders.

The ultracold chain requirements of mRNA COVID-19 vaccines are likely to be an insurmountable hurdle in LMICs, outside of major cities. COVID-19 vaccine delivery will require considerable investment of resources, health-care staff, and careful planning to avoid opportunity costs, including a disruption of routine health services and a decline in essential childhood vaccination coverage, which could result in outbreaks of measles and other vaccine-preventable diseases. There were more deaths from measles than Ebola virus disease in 2019 in the aftermath of the Ebola outbreak in the Democratic Republic of the Congo, due to failure to maintain adequate childhood vaccinations.¹¹ The infrastructure for vaccination in many LMICs is already inadequate, as shown by the 19·7 million under-vaccinated infants globally, most of whom are in these countries.¹² Thus, preparation for all aspects of COVID-19 vaccine delivery in LMICs must begin now with the support of international partners.

Strengthening the capacity of LMICs to do clinical trials and promoting LMIC participation in research are also crucial.¹³ More LMICs need to participate in future vaccine trials and in testing the clinical effectiveness of different therapeutic agents to ensure that interventions and implementation are suitable for local contexts.

Tracking the safety and effectiveness of different COVID-19 vaccines over time in various populations and settings will necessitate improvements in pharmacovigilance.¹⁴ Regulatory authorities in many LMICs need to be strengthened and could benefit from a programme of national and international support, as well as regional cooperation and reliance mechanisms.¹⁵ As part of internationally coordinated actions, COVID-19 technologies should be transferred to LMIC-based manufacturers, accompanied by regulatory guidance. Efforts to boost local manufacturing capacity in LMICs will contribute to equity, global solidarity, and global health security. India and South Africa have called for the suspension of intellectual property rights related to COVID-19 vaccines to improve access for LMICs, a move now supported by many other countries, but opposed by the pharmaceutical industry, which cites the disincentive to innovation.¹⁶

There are further challenges. Governments in LMICs with strong private health sectors, as those in high-income countries, will need to manage the inherent potential for inequity, whereby the rich could access COVID-19 vaccines before individuals with less access to private care who may be at increased risk of severe disease and death, such as older people and those with comorbidities. LMICs affected by war, civil conflict, economic crises, or natural disasters, or with large refugee populations or populations with special needs or vulnerabilities need additional support for vaccines and vaccination under extremely difficult operational conditions.

Re-examining global governance structures, including the UN and its Security Council, is much needed so that the voices and interests of billions of people in LMICs are better represented and recognised. Global support to multilateral institutions is essential to sustain their support to LMICs to facilitate vaccinations globally. The COVID-19 pandemic shows that no nation can stand alone. We are all part of a common humanity that requires us to respect our diverse experiences, cultures, and countries and forge partnerships that better serve the interests of all.
[Author conflicts and disclosures at title link above]

The Lancet
Feb 13, 2021 Volume 397 Number 10274 p555-640, e6
https://www.thelancet.com/journals/lancet/issue/current

Correspondence
COVID-19 vaccines for Palestinians
Graham Watt, Rita Giacaman, Huda Zurayk, Espen Bjertness, Gerd Holmboe-Ottesen, Hala Ghattas,
Iman Nuwayhid, Jennifer Leaning, John S Yudkin, Khamis Elessi, Richard Sullivan, Rima Afifi, Yousef S Khader, Harry S Shannon

Medical Decision Making (MDM)
Volume 41 Issue 2, February 2021
http://mdm.sagepub.com/content/current

Brief Reports
Feasibility of Rapidly Developing and Widely Disseminating Patient Decision Aids to Respond to Urgent Decisional Needs due to the COVID-19 Pandemic
Dawn Stacey, Claire Ludwig, Patrick Archambault, Kevin Babulic, Nancy Edwards, Josée Lavoie, Samir Sinha, Annette M. O’Connor
First Published December 10, 2020; pp. 233–239

Nature
Volume 590 Issue 7845, 11 February 2021
http://www.nature.com/nature/current_issue.html

Genome revolution
Editorial | 10 February 2021
The next 20 years of human genomics must be more equitable and more open
By re-committing to data sharing, researchers can fulfil the long-delayed promise of the Human Genome Project.

Nature
Volume 590 Issue 7845, 11 February 2021
http://www.nature.com/nature/current_issue.html

News Feature | 10 February 2021
The broken promise that undermines human genome research
Data sharing was a core principle that led to the success of the Human Genome Project 20 years ago. Now scientists are struggling to keep information free.
Kendall Powell

Nature
Volume 590 Issue 7845, 11 February 2021
http://www.nature.com/nature/current_issue.html

Comment | 10 February 2021
Sequence three million genomes across Africa
Capture the full scope of variation to improve health care, equity and medical research globally.
Ambroise Wonkam

Nature
Volume 590 Issue 7845, 11 February 2021
http://www.nature.com/nature/current_issue.html

Comment | 10 February 2021
A wealth of discovery built on the Human Genome Project — by the numbers
A new analysis traces the story of the draft genome’s impact on genomics since 2001, linking its effects on publications, drug approvals and understanding of disease.
Alexander J. Gates, Deisy Morselli Gysi & Albert-László Barabási

Nature
Volume 590 Issue 7845, 11 February 2021
http://www.nature.com/nature/current_issue.html

Review Article | 10 February 2021
Origins of modern human ancestry
A Review describes the three key phases that define the origins of modern human ancestry, and highlights the importance of analysing both palaeoanthropological and genomic records to further improve our understanding of our evolutionary history.
Anders Bergström, Chris Stringer & Pontus Skoglund

New England Journal of Medicine
February 11, 2021 Vol. 384 No. 6
http://www.nejm.org/toc/nejm/medical-journal

Original Article
Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results
WHO Solidarity Trial Consortium
Abstract
Background
World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs — remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a — in patients hospitalized with coronavirus disease 2019 (Covid-19).
Methods
We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry.
Results
At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan–Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P=0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P=0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P=0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P=0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration.
Conclusions
These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151. opens in new tab; ClinicalTrials.gov number, NCT04315948. opens in new tab.)

New England Journal of Medicine
February 11, 2021 Vol. 384 No. 6
http://www.nejm.org/toc/nejm/medical-journal

Original Article
Randomized Trial of a Vaccine Regimen to Prevent Chronic HCV Infection
Kimberly Page, Ph.D., M.P.H., et al
…In this trial, the HCV vaccine regimen did not cause serious adverse events, produced HCV-specific T-cell responses, and lowered the peak HCV RNA level, but it did not prevent chronic HCV infection. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT01436357. opens in new tab.)

PLoS One
http://www.plosone.org/
[Accessed 13 Feb 2021]

Active pharmacovigilance of the seasonal trivalent influenza vaccine produced by Instituto Butantan: A prospective cohort study of five target groups
Tazio Vanni, Beatriz da Costa Thomé, Mayra Martho Moura de Oliveira, Vera Lúcia Gattás, Maria da Graça Salomão, Marcelo Eiji Koike, Maria Beatriz Bastos Lucchesi, Patrícia Emília Braga, Roberta de Oliveira Piorelli, Juliana Yukari Koidara Viscondi, Gabriella Mondini, Anderson da Silva, Heloísa Maximo Espínola, Joane do Prado Santos, Samanta Hosokawa Dias de Nóvoa Rocha, Lily Yin Weckx, Olga Menang, Muriel Soquet, Alexander Roberto Precioso
Research Article | published 11 Feb 2021 PLOS ONE
https://doi.org/10.1371/journal.pone.0246540

PLoS One
http://www.plosone.org/
[Accessed 13 Feb 2021]

Knowledge, attitudes, and practices of seasonal influenza vaccination in postpartum women, Honduras
Zachary J. Madewell, Rafael Chacón-Fuentes, Jorge Jara, Homer Mejía-Santos, Ida-Berenice Molina, Juan Pablo Alvis-Estrada, Rosa Coello-Licona, Belinda Montejo
Research Article | published 11 Feb 2021 PLOS ONE
https://doi.org/10.1371/journal.pone.0246385

PLoS One
http://www.plosone.org/
[Accessed 13 Feb 2021]

Knowledge, attitudes, and practices of seasonal influenza vaccination among older adults in nursing homes and daycare centers, Honduras
Zachary J. Madewell, Rafael Chacón-Fuentes, Jorge Jara, Homer Mejía-Santos, Ida-Berenice Molina, Juan Pablo Alvis-Estrada, Raul Espinal
Research Article | published 11 Feb 2021 PLOS ONE
https://doi.org/10.1371/journal.pone.0246382

PLoS One
http://www.plosone.org/
[Accessed 13 Feb 2021]

Prioritizing investments in rapid response vaccine technologies for emerging infections: A portfolio decision analysis
Dimitrios Gouglas, Kevin Marsh
Research Article | published 11 Feb 2021 PLOS ONE
https://doi.org/10.1371/journal.pone.0246235