Who should be prioritized for COVID-19 vaccination in China? A descriptive study

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

Characterization of immunization secondary analyses using demographic and health surveys (DHS) and multiple indicator cluster surveys (MICS), 2006–2018

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

Community perspectives on the COVID-19 response, Zimbabwe

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

Government trust, perceptions of COVID-19 and behaviour change: cohort surveys, Singapore

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

Economic burden of COVID-19, China, January–March, 2020: a cost-of-illness study

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

A survey of national ethics and bioethics committees

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.

Immunity certification for COVID-19: ethical considerations

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.

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

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.

Details of risk–benefit communication in informed consent documents for phase I/II trials

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.

The effect of the ongoing civil strife on key immunisation outcomes in the North West and South West regions of Cameroon

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

Using digital technologies in clinical trials: Current and future applications

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.

Innovative trial designs and analyses for vaccine clinical development

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.

Disability inclusion in humanitarian action

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

 

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

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

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

The intentions to get vaccinated against influenza and actual vaccine uptake among diabetic patients in Ningbo, China: identifying motivators and barriers

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

Analysis of protective immune responses to seasonal influenza vaccination in HIV-infected individuals

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

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

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

Chinese mothers’ intention to vaccinate daughters against human papillomavirus (HPV), and their vaccine preferences: a study in Fujian Province

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

Control of vaccine preventable diseases in Australian infants: reviewing a decade of experience with DTPa-HBV-IPV/Hib vaccine

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

The COVID-19 Pandemic as an Opportunity to Ensure a More Successful Future for Science and Public Health

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.

Genetic Variants of SARS-CoV-2—What Do They Mean?

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.

Mandating COVID-19 Vaccines

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

Problems With Paying People to Be Vaccinated Against COVID-19

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.

Urgent needs of low-income and middle-income countries for COVID-19 vaccines and therapeutics

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.678

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]

Feasibility of Rapidly Developing and Widely Disseminating Patient Decision Aids to Respond to Urgent Decisional Needs due to the COVID-19 Pandemic

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

A wealth of discovery built on the Human Genome Project — by the numbers

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

Origins of modern human ancestry

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

Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results

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.)

Randomized Trial of a Vaccine Regimen to Prevent Chronic HCV Infection

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.)

Active pharmacovigilance of the seasonal trivalent influenza vaccine produced by Instituto Butantan: A prospective cohort study of five target groups

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

Knowledge, attitudes, and practices of seasonal influenza vaccination in postpartum women, Honduras

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

Knowledge, attitudes, and practices of seasonal influenza vaccination among older adults in nursing homes and daycare centers, Honduras

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

The epidemiologic and economic impact of a quadrivalent human papillomavirus vaccine in Thailand

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

 

The epidemiologic and economic impact of a quadrivalent human papillomavirus vaccine in Thailand
Wichai Termrungruanglert, Nipon Khemapech, Apichai Vasuratna, Piyalamporn Havanond, Preyanuch Deebukkham, Amit Sharad Kulkarni, Andrew Pavelyev
Research Article | published 11 Feb 2021 PLOS ONE
https://doi.org/10.1371/journal.pone.0245894

Determinants of vaccination dropout among children 12-23 months age in north Gondar zone, northwest Ethiopia, 2019

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

 

Determinants of vaccination dropout among children 12-23 months age in north Gondar zone, northwest Ethiopia, 2019
Muluken Genetu Chanie, Gojjam Eshetie Ewunetie, Asnakew Molla, Amare Muche
Research Article | published 08 Feb 2021 PLOS ONE
https://doi.org/10.1371/journal.pone.0246018

Cell-phone traces reveal infection-associated behavioral change

PNAS – Proceedings of the National Academy of Sciences of the United States of America
February 09, 2021; vol. 118 no. 6
https://www.pnas.org/content/118/6

 

Population Biology
Open Access
Cell-phone traces reveal infection-associated behavioral change
Ymir Vigfusson, Thorgeir A. Karlsson, Derek Onken, Congzheng Song, Atli F. Einarsson, Nishant Kishore, Rebecca M. Mitchell, Ellen Brooks-Pollock, Gudrun Sigmundsdottir, and Leon Danon
PNAS February 9, 2021 118 (6) e2005241118; https://doi.org/10.1073/pnas.2005241118
Significance
Infectious disease control critically depends on surveillance and predictive modeling of outbreaks. We argue that routine mobile-phone use can provide a source of infectious disease information via the measurements of behavioral changes in call-detail records (CDRs) collected for billing. In anonymous CDR metadata linked with individual health information from the A(H1N1)pdm09 outbreak in Iceland, we observe that people moved significantly less and placed fewer, but longer, calls in the few days around diagnosis than normal. These results suggest that disease-transmission models should explicitly consider behavior changes during outbreaks and advance mobile-phone traces as a potential universal data source for such efforts.

Strengthen scientific integrity under the Biden administration

Science
12 February 2021 Vol 371, Issue 6530
http://www.sciencemag.org/current.dtl

 

Policy Forum
Strengthen scientific integrity under the Biden administration
By Jacob M. Carter, Gretchen T. Goldman, Andrew A. Rosenberg, Genna Reed, Anita Desikan, Taryn MacKinney
Science12 Feb 2021 : 668-671 Restricted Access
Accountability must extend to highest levels of leadership
Summary
At his victory speech on 7 November 2020, U.S. president Joseph R. Biden described that the will of the people was in part to “marshal the forces of science.” He declared that his plans to beat the novel coronavirus would be built on a bedrock of science. On 27 January, the Biden administration issued a presidential memorandum to strengthen scientific integrity and evidence-based decision-making (1). These are great steps to bring science back to the table, but the administration still has a lot of work ahead to improve the role of science in government decision-making. The records of abuses of the past 4 years and data from surveys provide evidence that under the Trump administration, scientists were censored, scientific information was ignored, and reports and publications were unduly suppressed—all actions that undermined the appropriate use of science in decision-making processes. This occurred despite many federal agencies already having scientific integrity policies, communications policies, and well-established science advisory systems in place to promote an appropriate role for science in agency decision-making. But from these setbacks, we can draw lessons and suggest a road map for moving forward.

Advancing innovation for vaccine manufacturers from developing countries: Prioritization, barriers, opportunities

Vaccine
Volume 39, Issue 8 Pages 1173-1358 (22 February 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/8

 

Short communication Open access
Advancing innovation for vaccine manufacturers from developing countries: Prioritization, barriers, opportunities
Benoit Hayman, Alex Bowles, Beth Evans, Elizabeth Eyermann, … Sonia Pagliusi
Pages 1190-1194

Potential impact of COVID-19 pandemic on vaccination coverage in children: A case study of measles-containing vaccine administration in the United States (US)

Vaccine
Volume 39, Issue 8 Pages 1173-1358 (22 February 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/8

 

Short communication Full text access
Potential impact of COVID-19 pandemic on vaccination coverage in children: A case study of measles-containing vaccine administration in the United States (US)
Cristina Carias, Manjiri Pawaskar, Mawuli Nyaku, James H. Conway, … Ya-Ting Chen
Pages 1201-1204