How involvement of community pharmacies improves accessibility to and awareness about flu vaccination? – An example from Estonia

Expert Review of Vaccines
Vol 19 (109) 2020
https://www.tandfonline.com/toc/ierv20/current

 

Article
How involvement of community pharmacies improves accessibility to and awareness about flu vaccination? – An example from Estonia
Kristiina Sepp , Carmen Kukk , Afonso Cavaco & Daisy Volmer
Pages: 983-990
Published online: 05 Oct 2020

Simulation exercises and after action reviews – analysis of outputs during 2016–2019 to strengthen global health emergency preparedness and response

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 05 Dec 2020]

 

Research
Simulation exercises and after action reviews – analysis of outputs during 2016–2019 to strengthen global health emergency preparedness and response
Authors: Frederik Anton Copper, Landry Ndriko Mayigane, Yingxin Pei, Denis Charles, Thanh Nam Nguyen, Candice Vente, Cindy Chiu de Vázquez, Allan Bell, Hilary Kagume Njenge, Nirmal Kandel, Zheng Jie Marc Ho, Abbas Omaar, Stéphane de la Rocque and Stella Chungong
Content type:
1 December 2020
Under the International Health Regulations (2005) [IHR (2005)] Monitoring and Evaluation Framework, after action reviews (AAR) and simulation exercises (SimEx) are two critical components which measure the functionality of a country’s health emergency preparedness and response under a “real-life” event or simulated situation. The objective of this study was to describe the AAR and SimEx supported by the World Health Organization (WHO) globally in 2016–2019.

FDA efficiency for approval process of COVID-19 therapeutics

Infectious Agents and Cancer
http://www.infectagentscancer.com/content
[Accessed 05 Dec 2020]

 

Review
FDA efficiency for approval process of COVID-19 therapeutics
Authors: Christine Cassidy, Danielle Dever, Laura Stanbery, Gerald Edelman, Lance Dworkin and John Nemunaitis
1 December 2020
This review article examines the expedited FDA review process for remdesivir and hydroxychloroquine, and analyzes data and results from early clinical studies of both drugs.

Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19A Randomized Clinical Trial

JAMA
December 1, 2020, Vol 324, No. 21, Pages 2131-2222
https://jamanetwork.com/journals/jama/currentissue

 

Original Investigation
Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19A Randomized Clinical Trial
Wesley H. Self, MD, MPH; Matthew W. Semler, MD; Lindsay M. Leither, DO; et al.
free access has active quiz has audio
JAMA. 2020;324(21):2165-2176. doi:10.1001/jama.2020.22240
This randomized trial compares the effects of hydroxychloroquine vs placebo on clinical status at 14 days (home, requiring noninvasive or invasive ventilation or extracorporeal membrane oxygenation, hospitalized, died) among adults hospitalized with coronavirus disease 2019 (COVID-19).
Key Points
Question:  Does treatment with hydroxychloroquine improve clinical outcomes of adults hospitalized with coronavirus disease 2019 (COVID-19)?
Findings:  In this randomized clinical trial that included 479 hospitalized adults with respiratory symptoms from COVID-19, the distribution of the day 14 clinical status score (measured using a 7-category ordinal scale) was not significantly different for patients randomized to receive hydroxychloroquine compared with placebo (adjusted odds ratio, 1.02).
Meaning:  These findings do not support the use of hydroxychloroquine for treatment of COVID-19 among hospitalized adults.

Association of Use of a Meningococcus Group B Vaccine With Group B Invasive Meningococcal Disease Among Children in Portugal

JAMA
December 1, 2020, Vol 324, No. 21, Pages 2131-2222
https://jamanetwork.com/journals/jama/currentissue

 

Association of Use of a Meningococcus Group B Vaccine With Group B Invasive Meningococcal Disease Among Children in Portugal
Fernanda M. P. Rodrigues, PhD; Robin Marlow, PhD; Maria João Simões, PhD; et al.
has active quiz
JAMA. 2020;324(21):2187-2194. doi:10.1001/jama.2020.20449
This case-control study uses national hospital and immunization records in Portugal to estimates the difference in incidence of invasive group B meningococcal disease among children and adolescents who were immunized vs not immunized with 4CMenB, a 4-component meningococcus group B vaccine licensed in 2013.

Therapy for Early COVID-19 A Critical Need

JAMA
December 1, 2020, Vol 324, No. 21, Pages 2131-2222
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
Therapy for Early COVID-19A Critical Need
Peter S. Kim, MD; Sarah W. Read, MD, MHS; Anthony S. Fauci, MD
free access has active quiz
JAMA. 2020;324(21):2149-2150. doi:10.1001/jama.2020.22813
In this Viewpoint, Fauci and NIAID colleagues review leading candidates for treatment of mild to moderate coronavirus disease 2019 (COVID-19) to prevent disease progression and longer-term complications, including emerging antiviral drugs, immune-modulating agents, and antibody-based therapies, and the challenges of developing randomized trials to rapidly evaluate the safety and efficacy of each.

The Challenges Ahead With Monoclonal Antibodies From Authorization to Access

JAMA
December 1, 2020, Vol 324, No. 21, Pages 2131-2222
https://jamanetwork.com/journals/jama/currentissue

 

The Challenges Ahead With Monoclonal AntibodiesFrom Authorization to Access
Robert H. Goldstein, MD, PhD; Rochelle P. Walensky, MD, MPH
free access has active quiz
JAMA. 2020;324(21):2151-2152. doi:10.1001/jama.2020.21872
This Viewpoint discusses questions about clinical indication, supply, distribution, and cost and coverage that will need to be resolved if monoclonal antibodies are be granted Emergency Use Authorization or licensure and become available as treatment for COVID-19.

The carnage of substandard research during the COVID-19 pandemic: a call for quality :: Why continuing uncertainties are no reason to postpone challenge trials for coronavirus vaccines :: Uncertainty, error and informed consent to challenge trials of COVID-19 vaccines: response to Steel et al

Journal of Medical Ethics
December 2020 – Volume 46 – 12
http://jme.bmj.com/content/current

 

Covid 19 Current Controversies
The carnage of substandard research during the COVID-19 pandemic: a call for quality (1 October, 2020) Free
Katrina A Bramstedt
Abstract
Worldwide there are currently over 1200 research studies being performed on the topic of COVID-19. Many of these involve children and adults over age 65 years. There are also numerous studies testing investigational vaccines on healthy volunteers. No research team is exempt from the pressures and speed at which COVID-19 research is occurring. And this can increase the risk of honest error as well as misconduct. To date, 33 papers have been identified as unsuitable for public use and either retracted, withdrawn, or noted with concern. Asia is the source of most of these manuscripts (n=19; 57.6%) with China the largest Asian subgroup (n=11; 57.9%). This paper explores these findings and offers guidance for responsible research practice during pandemics.

Why continuing uncertainties are no reason to postpone challenge trials for coronavirus vaccines (13 July, 2020)
Robert Steel, Lara Buchak, Nir Eyal

Uncertainty, error and informed consent to challenge trials of COVID-19 vaccines: response to Steel et al (8 September, 2020) Free
Arnon Keren, Ori Lev

An African plan to control COVID-19 is urgently needed :: Action needed now to prevent further increases in measles and measles deaths in the coming years

The Lancet
Dec 05, 2020 Volume 396 Number 10265 p1777-1860, e90
https://www.thelancet.com/journals/lancet/issue/current

 

Editorial
An African plan to control COVID-19 is urgently needed
The Lancet

Comment
Action needed now to prevent further increases in measles and measles deaths in the coming years
Kim Mulholland, Katrina Kretsinger, Liya Wondwossen, Natasha Crowcroft
… The coming months are likely to see increasing numbers of unimmunised children who are susceptible to measles, many living in poor, remote communities where health systems are less resilient, and malnutrition and vitamin A deficiency are increasing. All these factors are likely to increase measles CFRs, creating the environment for measles to return in 2021, accompanied by increased mortality and the serious consequences of measles that were common decades ago.9
14 This is despite the fact that we have a highly cost-effective way to prevent this disease through measles vaccination.19
Three pillars of action are needed to address this concerning situation. First, urgent action is required to address the immediate risk of measles outbreaks by helping countries to reach unimmunised children through catch-up and campaigns. Second, countries need to prepare for the expected outbreaks. WHO and partners have developed a Strategic Response Plan to assist with measles outbreak prevention, preparedness, and response, and have launched a call to action and funding appeal.20
These additional resources would complement the support from Gavi, the Vaccine Alliance, which does not extend to many middle-income countries. Finally, the international community must not lose sight of measles and rubella elimination targets. The Measles & Rubella Initiative’s new Measles and Rubella Strategic Framework 2021–2030,21 aligned with WHO’s Immunization Agenda 2030,22
provides a plan for strengthening routine immunisation and surveillance. These are the solutions to end the cycle of inadequate immunisation and outbreaks of the past decade. Without concerted efforts now, it is likely that the coming years will see an increase in measles and its severe, frequently fatal, complications.

Tackling COVID-19 in the Eastern Mediterranean Region

The Lancet
Dec 05, 2020 Volume 396 Number 10265 p1777-1860, e90
https://www.thelancet.com/journals/lancet/issue/current

 

Tackling COVID-19 in the Eastern Mediterranean Region
Ahmed Salim Al-Mandhari, Richard J Brennan, Abdinasir Abubakar, ana Hajjeh
The main challenges to the COVID-19 response in the EMR include information sharing, expanding public health measures, protecting health workers, achieving behaviour change, ensuring continuity of essential health services, and establishing reliable supply chains.

Artificial intelligence in COVID-19 drug repurposing

Lancet Digital Health
Dec 2020 Volume 2 Number 12 e629-e680
https://www.thelancet.com/journals/landig/issue/current

 

Review
Artificial intelligence in COVID-19 drug repurposing
Yadi Zhou, et al
Summary
Drug repurposing or repositioning is a technique whereby existing drugs are used to treat emerging and challenging diseases, including COVID-19. Drug repurposing has become a promising approach because of the opportunity for reduced development timelines and overall costs. In the big data era, artificial intelligence (AI) and network medicine offer cutting-edge application of information science to defining disease, medicine, therapeutics, and identifying targets with the least error. In this Review, we introduce guidelines on how to use AI for accelerating drug repurposing or repositioning, for which AI approaches are not just formidable but are also necessary. We discuss how to use AI models in precision medicine, and as an example, how AI models can accelerate COVID-19 drug repurposing. Rapidly developing, powerful, and innovative AI and network medicine technologies can expedite therapeutic development. This Review provides a strong rationale for using AI-based assistive tools for drug repurposing medications for human disease, including during the COVID-19 pandemic.

Time to reality check the promises of machine learning-powered precision medicine

Lancet Digital Health
Dec 2020 Volume 2 Number 12 e629-e680
https://www.thelancet.com/journals/landig/issue/current

 

Viewpoint
Time to reality check the promises of machine learning-powered precision medicine
Jack Wilkinson, et al
Summary
Machine learning methods, combined with large electronic health databases, could enable a personalised approach to medicine through improved diagnosis and prediction of individual responses to therapies. If successful, this strategy would represent a revolution in clinical research and practice. However, although the vision of individually tailored medicine is alluring, there is a need to distinguish genuine potential from hype. We argue that the goal of personalised medical care faces serious challenges, many of which cannot be addressed through algorithmic complexity, and call for collaboration between traditional methodologists and experts in medical machine learning to avoid extensive research waste.

Cost-effectiveness of intermittent preventive treatment with dihydroartemisinin–piperaquine for malaria during pregnancy: an analysis using efficacy results from Uganda and Kenya, and pooled data

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

 

Cost-effectiveness of intermittent preventive treatment with dihydroartemisinin–piperaquine for malaria during pregnancy: an analysis using efficacy results from Uganda and Kenya, and pooled data
Silke Fernandes, et al.

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

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

 

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

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

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

 

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

Immunological considerations for SARS-CoV-2 human challenge studies

Nature Reviews Immunology
Volume 20 Issue 12, December 2020
https://www.nature.com/nri/volumes/20/issues/12

 

Comment | 21 October 2020
Immunological considerations for SARS-CoV-2 human challenge studies
In this Comment article, Sandy Douglas and Adrian Hill discuss the immunological considerations associated with a risk–benefit analysis for controlled human infection models of SARS-CoV-2.
Alexander D. Douglas  & Adrian V. S. Hill

Measuring immunity to SARS-CoV-2 infection: comparing assays and animal models

Nature Reviews Immunology
Volume 20 Issue 12, December 2020
https://www.nature.com/nri/volumes/20/issues/12

 

Review Article | 02 November 2020
Measuring immunity to SARS-CoV-2 infection: comparing assays and animal models
Are you new to virus research and trying to interpret the ever-expanding literature on immunity to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)? Here, the authors compare the different assays and animal models used to measure immunity to SARS-CoV-2 infection and reconcile differences in apparent potency of antibodies assessed in different assays.
David S. Khoury, Adam K. Wheatley […]  & Miles P. Davenport

Informing single-arm clinical trials with external controls

Nature Reviews Drug Discovery
Volume 19 Issue 12, December 2020
https://www.nature.com/nrd/volumes/19/issues/12

 

Comment | 18 August 2020
Informing single-arm clinical trials with external controls
Randomized controlled trials are the accepted standard for evaluating investigational therapies, but such trials are sometimes not an option for reasons of ethics or feasibility. Here, we discuss opportunities to address evidence gaps by using historical clinical trial data and real-world data in external control arms for single-arm trials, as well as the associated challenges.
Ruthie Davi , Nirosha Mahendraratnam […]  & Rachel Sherman

A highly immunogenic and effective measles virus-based Th1-biased COVID-19 vaccine

PNAS – Proceedings of the National Academy of Sciences of the United States of America
http://www.pnas.org/content/early/

 

Articles
A highly immunogenic and effective measles virus-based Th1-biased COVID-19 vaccine
Cindy Hörner, Christoph Schürmann, Arne Auste, Aileen Ebenig, Samada Muraleedharan, Kenneth H. Dinnon III, Tatjana Scholz, Maike Herrmann, Barbara S. Schnierle, Ralph S. Baric, and Michael D. Mühlebach
PNAS first published November 30, 2020. https://doi.org/10.1073/pnas.2014468117

Planning universal accessibility to public health care in sub-Saharan Africa

PNAS – Proceedings of the National Academy of Sciences of the United States of America
http://www.pnas.org/content/early/

Planning universal accessibility to public health care in sub-Saharan Africa
Giacomo Falchetta, Ahmed T. Hammad, and Soheil Shayegh

 

PNAS first published November 30, 2020. https://doi.org/10.1073/pnas.2009172117
Significance
Achieving universal health care access is a key development priority and a target of Sustainable Development Goal number 3. The COVID-19 pandemic has only reinforced this urge. A rapid expansion of public, affordable health care infrastructure is particularly crucial in sub-Saharan Africa (SSA): communicable diseases are the first cause of death, infant mortality rates are above 5%, and lengthy journeys to health care facilities undermine the accessibility to basic health care for millions. This paper provides a planning-oriented, inequality-focused analysis of health care accessibility in SSA based on a state-of-the-art georeferenced database of public health care facilities. We devise a spatial optimization framework to identify the optimal location and required bed capacity of public health care facilities in the region.

The impact of shared decision making with patient decision aids on the rotavirus vaccination rate in children: A randomized controlled trial

Preventive Medicine
Volume 141 December 2020
https://www.sciencedirect.com/journal/preventive-medicine/vol/141/suppl/C

 

Research article Abstract only
The impact of shared decision making with patient decision aids on the rotavirus vaccination rate in children: A randomized controlled trial
Sheng-Chieh Lin, Ka-Wai Tam, Jean Yu-Chun Yen, Meng-Che Lu, … Shih-Yen Chen
Article 106244

Public Health Ethics in a Pandemic

Public Health Ethics
Volume 13, Issue 2, July 2020
http://phe.oxfordjournals.org/content/current

 

Editorial
Public Health Ethics in a Pandemic
Marcel Verweij, Angus Dawson
Public Health Ethics, Volume 13, Issue 2, July 2020, Pages 125–126, https://doi.org/10.1093/phe/phaa032
Extract
Ten years ago, we (re)published a historical pamphlet written during the 1665 Great Plague, by an anonymous inhabitant of London, entitled The Shutting Up Infected Houses (Anonymous, 2010; Verweij and Dawson, 2010). The author vividly argued against the practice of locking people up in their own houses as a means of preventing further disease transmission within the community. Many of those imprisoned in their own houses might not have been sick or infected at all. They were not treated as victims, but first and foremost, as a threat to others. The ‘quarantined’ families could only…

Vaccinating for Whom? Distinguishing between Self-Protective, Paternalistic, Altruistic and Indirect Vaccination

Public Health Ethics
Volume 13, Issue 2, July 2020
http://phe.oxfordjournals.org/content/current

 

Original Articles: Ethics of vaccination
Vaccinating for Whom? Distinguishing between Self-Protective, Paternalistic, Altruistic and Indirect Vaccination
Steven R Kraaijeveld
Public Health Ethics, Volume 13, Issue 2, July 2020, Pages 190–200, https://doi.org/10.1093/phe/phaa005
Abstract
Preventive vaccination can protect not just vaccinated individuals, but also others, which is often a central point in discussions about vaccination. To date, there has been no systematic study of self- and other-directed motives behind vaccination. This article has two major goals: first, to examine and distinguish between self- and other-directed motives behind vaccination, especially with regard to vaccinating for the sake of third parties, and second, to explore some ways in which this approach can help to clarify and guide vaccination debates and policy. I propose conceiving of vaccination in terms of three basic elements: the vaccination decision-maker, the vaccine recipient and the primary beneficiary. I develop a taxonomy based on the relations between these elements to distinguish four kinds of vaccination: self-protective, paternalistic, altruistic and indirect. I finally discuss the case of human papillomavirus vaccine regulation for men and women to show how each kind of vaccination is associated with and raises specific ethical questions

Vaccination Policies: Between Best and Basic Interests of the Child, between Precaution and Proportionality

Public Health Ethics
Volume 13, Issue 2, July 2020
http://phe.oxfordjournals.org/content/current

 

Vaccination Policies: Between Best and Basic Interests of the Child, between Precaution and Proportionality
Roland Pierik r.pierik@uva.nl
Public Health Ethics, Volume 13, Issue 2, July 2020, Pages 201–214, https://doi.org/10.1093/phe/phaa008
Abstract
How should liberal-democratic governments deal with emerging vaccination hesitancy when that leads to the resurgence of diseases that for decades were under control? This article argues that vaccination policies should be justified in terms of a proper weighing of the rights of children to be protected against vaccine-preventable diseases and the rights of parents to raise their children in ways that they see fit. The argument starts from the concept of the ‘best interests of the child involved’. The concept is elaborated for this context into the dual regime structure in which parents have fiduciary authority over what they consider to be best for their child, and the state has fiduciary authority over a child’s basic interests. This argument leads to conditional mandatory vaccination programs that should be informed by a correct balancing of the two legal principles of proportionality and precaution. This results in contextual childhood vaccination policies of upscaling interference: a three-tiered approach of increased intrusion, from voluntary program when possible and mandatory or even compulsory programs when necessary to protect the child’s basic interests.

Global Measles Epidemic Risk: Current Perspectives on the Growing Need for Implementing Digital Communication Strategies

Risk Management and Healthcare Policy
https://www.dovepress.com/risk-management-and-healthcare-policy-archive56
[Accessed 05 Dec 2020]

 

Review
Global Measles Epidemic Risk: Current Perspectives on the Growing Need for Implementing Digital Communication Strategies
Bozzola E, Spina G, Tozzi AE, Villani A
Published Date: 3 December 2020

A blueprint for translational regenerative medicine

Science Translational Medicine
02 December 2020 Vol 12, Issue 572
https://stm.sciencemag.org/

 

Review
A blueprint for translational regenerative medicine
By James P. K. Armstrong, Timothy J. Keane, Anne C. Roques, P. Stephen Patrick, Claire M. Mooney, Wei-Li Kuan, Venkat Pisupati, Richard O. C. Oreffo, Daniel J. Stuckey, Fiona M. Watt, Stuart J. Forbes, Roger A. Barker, Molly M. Stevens
Science Translational Medicine02 Dec 2020 Full Access
This Review outlines a practical blueprint for academics seeking to develop translational regenerative therapies.
Abstract
The past few decades have produced a large number of proof-of-concept studies in regenerative medicine. However, the route to clinical adoption is fraught with technical and translational obstacles that frequently consign promising academic solutions to the so-called “valley of death.” Here, we present a proposed blueprint for translational regenerative medicine. We offer principles to help guide the selection of cells and materials, present key in vivo imaging modalities, and argue that the host immune response should be considered throughout design and development. Last, we suggest a pathway to navigate the often complex regulatory and manufacturing landscape of translational regenerative medicine.

Next-generation rotavirus vaccine developers meeting: Summary of a meeting sponsored by PATH and the bill & melinda gates foundation (19–20 June 2019, Geneva)

Vaccine
Volume 38, Issue 52 Pages 8247-8412 (14 December 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/52

 

Conference info Abstract only
Next-generation rotavirus vaccine developers meeting: Summary of a meeting sponsored by PATH and the bill & melinda gates foundation (19–20 June 2019, Geneva)
Alan Fix, Carl D. Kirkwood, Duncan Steele, Jorge Flores
Pages 8247-8254

Parental preferences for HPV vaccination in junior middle school girls in China: A discrete choice experiment

Vaccine
Volume 38, Issue 52 Pages 8247-8412 (14 December 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/52

 

Research article Abstract only
Parental preferences for HPV vaccination in junior middle school girls in China: A discrete choice experiment
Shan Zhu, Jie Chang, Khezar Hayat, Pengchao Li, … Yu Fang
Pages 8310-8317

The role of manufacturers in the implementation of global traceability standards in the supply chain to combat vaccine counterfeiting and enhance safety monitoring

Vaccine
Volume 38, Issue 52 Pages 8247-8412 (14 December 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/52

 

Research article Open access
The role of manufacturers in the implementation of global traceability standards in the supply chain to combat vaccine counterfeiting and enhance safety monitoring
Stephen Jarrett, Taufik Wilmansyah, Yudha Bramanti, Hikmat Alitamsar, … Sonia Pagliusi
Pages 8318-8325

A survey of office practice: Parents, front office staff, nurses and clinicians hold disparate views on adolescent vaccines

Vaccine
Volume 38, Issue 52 Pages 8247-8412 (14 December 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/52

 

Research article Abstract only
A survey of office practice: Parents, front office staff, nurses and clinicians hold disparate views on adolescent vaccines
James R. Roberts, Erin Dawley, Connor Garbe, Townsend Cooper, … Paul M. Darden
Pages 8326-8333