Monthly Archives: September 2020

Artificial Intelligence and Mechanistic Modeling for Clinical Decision Making in Oncology

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Clinical Pharmacology & Therapeutics
Volume 108, Issue 3 September 2020
https://ascpt.onlinelibrary.wiley.com/toc/15326535/current

 

Reviews
State of the Art
Artificial Intelligence and Mechanistic Modeling for Clinical Decision Making in Oncology
Sebastien Benzekry
Pages: 471-486
First Published:18 June 2020
Abstract
The amount of “big” data generated in clinical oncology, whether from molecular, imaging, pharmacological, or biological origin, brings novel challenges. To mine efficiently this source of information, mathematical models able to produce predictive algorithms and simulations are required, with applications for diagnosis, prognosis, drug development, or prediction of the response to therapy. Such mathematical and computational constructs can be subdivided into two broad classes: biologically agnostic, statistical models using artificial intelligence techniques, and physiologically based, mechanistic models. In this review, recent advances in the applications of such methods in clinical oncology are outlined. These include machine learning applied to big data (omics, imaging, or electronic health records), pharmacometrics and quantitative systems pharmacology, as well as tumor kinetics and metastasis modeling. Focus is set on studies with high potential of clinical translation, and particular attention is given to cancer immunotherapy. Perspectives are given in terms of combinations of the two approaches: “mechanistic learning.”

The Changing Face of Oncology Research, Drug Development, and Clinical Practice: Toward Patient‐Focused Precision Therapeutics

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Clinical Pharmacology & Therapeutics
Volume 108, Issue 3 September 2020
https://ascpt.onlinelibrary.wiley.com/toc/15326535/current

 

Editorial
The Changing Face of Oncology Research, Drug Development, and Clinical Practice: Toward Patient‐Focused Precision Therapeutics
Karthik Venkatakrishnan, Piet H. van der Graaf. Sarah A. Holstein
Pages: 399-404
First Published:19 August 2020

The second coming : The comeback of the live vaccines

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EMBO Reports
Volume 21 Issue 9 3 September 2020
https://www.embopress.org/toc/14693178/current

 

Science & Society 1 September 2020
The second coming : The comeback of the live vaccines
Anthony King
Live vaccines are gradually replaced by protein‐based vaccines given the latter’s better safety. But live vaccines seem to be more efficient via stimulation of the innate immune system.

A systematic review of vaccine availability at the national, district, and health facility level in the WHO African Region

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Expert Review of Vaccines
Vol 19 (7) 2020
https://www.tandfonline.com/toc/ierv20/current

 

Review
A systematic review of vaccine availability at the national, district, and health facility level in the WHO African Region
To describe vaccine stock-outs at national, district, and health facility levels in the WHO African region.
Chinwe Juliana Iwu , Ntombehle Ngcobo , Anelisa Jaca , Alison Wiyeh , Elizabeth Pienaar , Usuf Chikte & Charles S. Wiysonge
Pages: 639-651
Published online: 10 Aug 2020

Educating, training, and exercising for infectious disease control with emphasis on cross-border settings: an integrative review

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

 

Articles
Educating, training, and exercising for infectious disease control with emphasis on cross-border settings: an integrative review
Points of entry and other border regions educate, train, and exercise (ETEs) their staff to improve preparedness and response to cross-border health threats. However, no conclusive knowledge of these ETEs’ eff…
Authors: Doret de Rooij, Evelien Belfroid, Christos Hadjichristodoulou, Varvara A. Mouchtouri, Jörg Raab and Aura Timen
Citation: Globalization and Health 2020 16:78
Content type: Review
Published on: 3 September 2020

Reopening K-12 Schools During the COVID-19 PandemicA Report From the National Academies of Sciences, Engineering, and Medicine

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JAMA
September 1, 2020, Vol 324, No. 9, Pages 823-908
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
Reopening K-12 Schools During the COVID-19 PandemicA Report From the National Academies of Sciences, Engineering, and Medicine
Kenne A. Dibner, PhD; Heidi A. Schweingruber, PhD; Dimitri A. Christakis, MD, MPH
free access
JAMA. 2020;324(9):833-834. doi:10.1001/jama.2020.14745
This Viewpoint summarizes recommendations made in a National Academies of Sciences, Engineering, and Medicine report about how to safely reopen and operate elementary and secondary schools for the 2020-2021 school year, which emphasizes the need for partnerships with public health officials and community leaders, and for transparent communication of risks and rewards that will result from every policy decision.

Universal Masking in the United StatesThe Role of Mandates, Health Education, and the CDC

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JAMA
September 1, 2020, Vol 324, No. 9, Pages 823-908
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
Universal Masking in the United StatesThe Role of Mandates, Health Education, and the CDC
Lawrence O. Gostin, JD; I. Glenn Cohen, JD; Jeffrey P. Koplan, MD, MPH
free access has active quiz
JAMA. 2020;324(9):837-838. doi:10.1001/jama.2020.15271
This Viewpoint proposes legal and policy options for promoting universal face mask wearing in the US and, recognizing the limits of state-by-state implementation, proposes strengthening the authority, independence, and funding of the CDC to enact responses to this and future comparable public health emergencies.

Extended essays Human infection challenge studies in endemic settings and/or low-income and middle-income countries: key points of ethical consensus and controversy

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Journal of Medical Ethics
September 2020 – Volume 46 – 9
http://jme.bmj.com/content/current

 

Extended essays
Human infection challenge studies in endemic settings and/or low-income and middle-income countries: key points of ethical consensus and controversy (7 May, 2020)
Euzebiusz Jamrozik, Michael J Selgelid

Factors Affecting Implementation of Evidence-Based Practices in Public Health Preparedness and Response

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Journal of Public Health Management & Practice
September/October 2020 – Volume 26 – Issue 5
https://journals.lww.com/jphmp/pages/currenttoc.aspx

 

Research Reports
Factors Affecting Implementation of Evidence-Based Practices in Public Health Preparedness and Response
Kennedy, Mallory; Carbone, Eric G.; Siegfried, Alexa L.; More
Journal of Public Health Management and Practice. 26(5):434-442, September/October 2020.

Health sector spending and spending on HIV/AIDS, tuberculosis, and malaria, and development assistance for health: progress towards Sustainable Development Goal 3

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The Lancet
Sep 05, 2020 Volume 396 Number 10252 p649-734, e22-e24
https://www.thelancet.com/journals/lancet/issue/current

 

Articles
Health sector spending and spending on HIV/AIDS, tuberculosis, and malaria, and development assistance for health: progress towards Sustainable Development Goal 3
Global Burden of Disease Health Financing Collaborator Network
Open Access

COVID-19 vaccines: early success and remaining challenges

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The Lancet
Sep 05, 2020 Volume 396 Number 10252 p649-734, e22-e24
https://www.thelancet.com/journals/lancet/issue/current

 

Online First
Comment
COVID-19 vaccines: early success and remaining challenges
Naor Bar-Zeev,
Tom Inglesby
…The two studies by Logunov and colleagues have several strengths. First, adenoviruses are ubiquitous, so humans might not be immunologically naive. Previous immunity to the vector might interfere with adenovirus-vectored COVID-19 vaccine efficacy. Indeed, findings of an adenovirus type 5-vectored COVID-19 vaccine trial suggested such immunity could affect COVID-19 responses.2 In another study, a chimpanzee adenovirus vector was used, since humans will presumably be naive to at least the first dose.3 Logunov and colleagues used immunologically distinct (heterologous) vectors in their two-dose (prime-boost) regimen. They investigated cross-vector heterologous immunity and previous antivector adenovirus immunity, and neither affected COVID-19 immunogenicity.

A second strength is the threshold for neutralisation used in the two studies. Neutralisation assays vary from study to study. Neutralisation is tested by examining whether plasma from a recently vaccinated individual can prevent cellular damage on in-vitro exposure of cells to SARS-CoV-2. Both the degree of such protection (how many damaged cells are allowed) and the dose of the infecting virus vary across studies. Expecting a vaccine to result in less than complete neutralisation is not inherently wrong but sets the bar low and makes it easier to claim neutralising activity. In Logunov and colleagues’ studies, however, the threshold for neutralisation was set high in two regards: the inoculating viral dose was large, and no arising cellular damage was allowable. Essentially, the assay was set at full neutralisation. This high bar implies these researchers took an a-priori risk that their vaccine might fail the test. It did not. It remains to be seen if other manufacturers will set a similar high standard.

A third strength is that the vaccine, similar to other adenovirus-vectored and mRNA COVID-19 vaccines before it,2  3, 4 induced broad immune responses. Although not specifically discussed, the results imply a T-helper-1-cell-weighted response that might be important for vaccine safety, potentially reducing the risk of antibody-dependent enhanced disease.5

A fourth strength was development of two vaccine formulations, frozen and lyophilised. A lyophilised formulation could mean stability within the existing global vaccine refrigerated cold chain that is needed to maintain vaccine efficacy from factory to recipient, a hurdle other vaccines are yet to address. Although more costly to produce at scale, product stability will maximise reach in remote terrain, a must if universal and equitable coverage is to be achieved.

Some limitations of the studies by Logunov and colleagues are notable. In the study of the frozen vaccine formulation, the population included young military personnel. Soldiers are likely to be fitter and healthier than the general population. Moreover, in older adults, immune senescence might make vaccines less immunogenic, and this age group was absent from this study. Sex imbalance occurred in the study arms because there was no random allocation. A control arm was conspicuously absent. Two participants were of Asian descent, with the rest of the participants of white European ethnic origin. Clearly, much more remains to be learned from the phase 3 randomised trial planned to include 40 000 civilian volunteers and, hopefully, broadly inclusive of groups at risk…

Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia

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The Lancet
Sep 05, 2020 Volume 396 Number 10252 p649-734, e22-e24
https://www.thelancet.com/journals/lancet/issue/current

 

Online First
Articles
Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia
Denis Y Logunov, et al
Summary
Background
We developed a heterologous COVID-19 vaccine consisting of two components, a recombinant adenovirus type 26 (rAd26) vector and a recombinant adenovirus type 5 (rAd5) vector, both carrying the gene for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike glycoprotein (rAd26-S and rAd5-S). We aimed to assess the safety and immunogenicity of two formulations (frozen and lyophilised) of this vaccine.
Methods
We did two open, non-randomised phase 1/2 studies at two hospitals in Russia. We enrolled healthy adult volunteers (men and women) aged 18–60 years to both studies. In phase 1 of each study, we administered intramuscularly on day 0 either one dose of rAd26-S or one dose of rAd5-S and assessed the safety of the two components for 28 days. In phase 2 of the study, which began no earlier than 5 days after phase 1 vaccination, we administered intramuscularly a prime-boost vaccination, with rAd26-S given on day 0 and rAd5-S on day 21. Primary outcome measures were antigen-specific humoral immunity (SARS-CoV-2-specific antibodies measured by ELISA on days 0, 14, 21, 28, and 42) and safety (number of participants with adverse events monitored throughout the study). Secondary outcome measures were antigen-specific cellular immunity (T-cell responses and interferon-γ concentration) and change in neutralising antibodies (detected with a SARS-CoV-2 neutralisation assay). These trials are registered with ClinicalTrials.gov, NCT04436471 and NCT04437875.
Findings
Between June 18 and Aug 3, 2020, we enrolled 76 participants to the two studies (38 in each study). In each study, nine volunteers received rAd26-S in phase 1, nine received rAd5-S in phase 1, and 20 received rAd26-S and rAd5-S in phase 2. Both vaccine formulations were safe and well tolerated. The most common adverse events were pain at injection site (44 [58%]), hyperthermia (38 [50%]), headache (32 [42%]), asthenia (21 [28%]), and muscle and joint pain (18 [24%]). Most adverse events were mild and no serious adverse events were detected. All participants produced antibodies to SARS-CoV-2 glycoprotein. At day 42, receptor binding domain-specific IgG titres were 14 703 with the frozen formulation and 11 143 with the lyophilised formulation, and neutralising antibodies were 49·25 with the frozen formulation and 45·95 with the lyophilised formulation, with a seroconversion rate of 100%. Cell-mediated responses were detected in all participants at day 28, with median cell proliferation of 2·5% CD4+ and 1·3% CD8+ with the frozen formulation, and a median cell proliferation of 1·3% CD4+ and 1·1% CD8+ with the lyophilised formulation.
Interpretation
The heterologous rAd26 and rAd5 vector-based COVID-19 vaccine has a good safety profile and induced strong humoral and cellular immune responses in participants. Further investigation is needed of the effectiveness of this vaccine for prevention of COVID-19.
Funding
Ministry of Health of the Russian Federation.

The Tragedy of Measles

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New England Journal of Medicine
September 3, 2020 Vol. 383 No. 10
http://www.nejm.org/toc/nejm/medical-journal

 

The Tragedy of Measles
Perri Klass, M.D.
Although measles has always had serious complications, it was not necessarily treated seriously in popular culture, even before the MMR vaccine became available. But there is a harrowing measles tragedy from one of America’s great tragedians, Eugene O’Neill.

Accelerating Development of SARS-CoV-2 Vaccines — The Role for Controlled Human Infection Models

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New England Journal of Medicine
September 3, 2020 Vol. 383 No. 10
http://www.nejm.org/toc/nejm/medical-journal

 

Accelerating Development of SARS-CoV-2 Vaccines — The Role for Controlled Human Infection Models
Meagan E. Deming, M.D., Ph.D., Nelson L. Michael, M.D., Ph.D., Merlin Robb, M.D., Myron S. Cohen, M.D., and Kathleen M. Neuzil, M.D., M.P.H.

Economic influences on population health in the United States: Toward policymaking driven by data and evidence

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PLoS Medicine
http://www.plosmedicine.org/
(Accessed 5 Sep 2020)

 

Economic influences on population health in the United States: Toward policymaking driven by data and evidence
Atheendar S. Venkataramani, Rourke O’Brien, Gregory L. Whitehorn, Alexander C. Tsai
Collection Review | published 02 Sep 2020 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1003319

In flux and under threat

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Science
04 September 2020 Vol 369, Issue 6508
http://www.sciencemag.org/current.dtl

 

Special Issue – Democracy in the Balance
Introduction to special issue
In flux and under threat
By Tage Rai, Brad Wible
Science04 Sep 2020 : 1174-1175
Around the world, democracy is losing ground. Polarization and disinformation have rendered liberals and conservatives unable to agree on basic facts. State violence and suppression of citizens’ rights are resurgent. Free and fair elections are being threatened.

In this special issue, we critically examine the state of democracy and how it must adapt to achieve its ideals in the 21st century. We need to meet the challenges and opportunities of living in increasingly multiethnic societies, of fostering democracy in a weakened international environment, of reducing inequality and elevating the political representation of the poor, and of organizing social movements and combating disinformation tactics in the digital age. Advances in technology are making it easier to distort true voter representation through gerrymandering, and political campaigns continue to struggle with reaching voters and persuading them to participate. Worryingly, state violence, which has always been a core feature of the democratic experience for some, is spreading in democratic societies.

Twenty years ago, it seemed inevitable that democracy would reach every corner of the globe. In this moment, we are reminded that we must fight for democracy and work to improve it. A scientific understanding of the social and behavioral phenomena that underlie its operation will help us enhance democracy and, by doing so, improve human lives and societies globally.

Media/Policy Watch

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

 

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 5 Sep 2020
[No new, unique, relevant content]

 

BBC
http://www.bbc.co.uk/
Accessed 5 Sep 2020
[No new, unique, relevant content]

 

The Economist
http://www.economist.com/
Accessed 5 Sep 2020
Babbage
The fast and the spurious—the dangers of rushing a covid-19 vaccine
Sep 2nd 2020

 

Forbes
http://www.forbes.com/
Accessed 5 Sep 2020
[No new, unique, relevant content]

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 5 Sep 2020
The Tragedy of Vaccine Nationalism
Only Cooperation Can End the Pandemic
By Thomas J. Bollyky and Chad P. Bown
September/October 2020

 

Foreign Policy
http://foreignpolicy.com/
Voice
Trump’s Vaccine Can’t Be Trusted
If a vaccine comes out before the election, there are very good reasons not to take it.
Laurie Garrett
September 3, 2020,

 

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

 

New Yorker
http://www.newyorker.com/
Accessed 5 Sep 2020
[No new, unique, relevant content]

 

New York Times
http://www.nytimes.com/
Accessed 5 Sep 2020
Politics
Kamala Harris Says Trump Not Credible on Possible COVID-19 Vaccine
Democratic U.S. vice presidential candidate Kamala Harris said she would not take President Donald Trump’s word alone on any potential coronavirus vaccine.
By Reuters Sept. 5

Politics
Race for Coronavirus Vaccine Pits Spy Against Spy
The intelligence wars over vaccine research have intensified as China and Russia expand their efforts to steal American work at both research institutes and companies.
By Julian E. Barnes and Michael Venutolo-Mantovani Sept. 5

Europe
Sanofi France Chief: Future COVID-19 Vaccine Seen Below 10 Euros
Sanofi’s chief in France, Olivier Bogillot, said on Saturday that its future COVID-19 vaccine was likely to be priced below 10 euros per shot.
By Reuters Sept. 5

Asia Pacific
China’s CNBG, Sinovac Find More Countries to Test Coronavirus Vaccines
China National Biotec Group (CNBG) and Sinovac Biotech Ltd said on Saturday they have each found two more countries to run late-stage clinical tests of their coronavirus vaccine candidates, as China steps up its efforts in the global race.
By Reuters Sept. 5

World
UN Assembly President: ‘Inclusion Is Key’ for Virus Vaccine
The president of the U.N. General Assembly is warning that a vaccine for COVID-19 must be made available to everyone who needs it because if just one country is left out the world will still face a crisis from the coronavirus.
By The Associated Press Sept. 4

Europe
UN: No Vaccine to Be Endorsed Before It’s Safe and Effective
The head of the World Health Organization said the U.
By The Associated Press Sept. 4

Europe
WHO Chief Scientist: ‘We Should See Vaccine Rollout by Mid-2021’
The World Health Organization is hopeful that a novel coronavirus vaccine will be ready internationally by mid-2021, its chief scientist said on Friday.
By Reuters Sept. 4

Europe
WHO’s Tedros Says ‘Vaccine Nationalism’ Would Prolong Pandemic
WHO Director-General Tedros Adhanom Ghebreyesus said on Friday that “vaccine nationalism” would only slow the effort to quash the pandemic and called for vaccines to be used fairly and effectively.
By Reuters Sept. 4

 

Washington Post
https://www.washingtonpost.com/
Accessed 5 Sep 2020
[No new, unique, relevant content]

Think Tanks et al

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Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 5 Sep 2020
[No new relevant content]

 

Center for Global Development [to 5 Sep 2020]
http://www.cgdev.org/page/press-center
Accessed 5 Sep 2020
[No new relevant content]

 

Chatham House [to 5 Sep 2020]
https://www.chathamhouse.org/
[No new relevant content]

 

CSIS
https://www.csis.org/
Accessed 5 Sep 2020
Commentary
The Risks of Misinformation and Vaccine Hesitancy within the Covid-19 Crisis
September 4, 2020 | By Katherine E. Bliss, J. Stephen Morrison

 

Council on Foreign Relations
http://www.cfr.org/
Accessed 5 Sep 2020
[No new relevant content]

 

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 5 Sep 2020
[No new relevant content]