Fairly Prioritizing Groups for Access to COVID-19 Vaccines

JAMA
October 27, 2020, Vol 324, No. 16, Pages 1589-1690
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint September 10, 2020
Fairly Prioritizing Groups for Access to COVID-19 Vaccines
Govind Persad, JD, PhD; Monica E. Peek, MD, MPH, MS; Ezekiel J. Emanuel, MD, PhD
free access has active quiz has multimedia has audio
JAMA. 2020;324(16):1601-1602. doi:10.1001/jama.2020.18513
This Viewpoint proposes that ethical principles of preventing harm, helping disadvantaged populations, and achieving equal treatment should guide COVID-19 vaccine distribution, supporting initial allocation to health care workers, people in high-risk occupations and housing, and those with high-risk medical conditions.

African diversity

Nature
Volume 586 Issue 7831, 29 October 2020
http://www.nature.com/nature/current_issue.html

 

African diversity
Although Africa is regarded as the cradle of modern humans, only a fraction of the genetic diversity among African individuals has been surveyed. In this week’s issue, Zané Lombard, Adebowale Adeyemo, Neil Hanchard and their colleagues from the H3Africa Consortium help to redress this imbalance by presenting whole-genome sequence analyses of 426 individuals covering 50 ethnolinguistic groups. The researchers uncovered more than three million new variants, mostly among newly sampled groups, and identified 62 previously unreported genes associated with viral immunity, DNA repair and metabolism. They also observed complex patterns of ancestral mixing within and between populations, and found evidence that Zambia was a likely intermediate site along the routes of expansion for Bantu-speaking populations. The findings help to refine understanding of migration across the African continent and identify gene flow and response to disease as strong drivers of genome-level population variation. The cover shows a subset of the genetic data collected in the study translated into hand-loomed beaded necklaces by the Marigold beadwork cooperative in Zimbabwe.

Strategic vision for improving human health at The Forefront of Genomics

Nature
Volume 586 Issue 7831, 29 October 2020
http://www.nature.com/nature/current_issue.html

 

Perspective | 28 October 2020
Strategic vision for improving human health at The Forefront of Genomics
In this Perspective, authors from the National Human Genome Research Institute (NHGRI) present a vision for human genomics research for the coming decade.
Eric D. Green, Chris Gunter[…] & Teri A. Manolio

High-depth African genomes inform human migration and health

Nature
Volume 586 Issue 7831, 29 October 2020
http://www.nature.com/nature/current_issue.html

 

Article | 28 October 2020
High-depth African genomes inform human migration and health
Whole-genome sequencing analyses of African populations provide insights into continental migration, gene flow and the response to human disease, highlighting the importance of including diverse populations in genomic analyses to understand human ancestry and improve health.
Ananyo Choudhury, Shaun Aron[…] & Neil A. Hanchard

Exome sequencing and characterization of 49,960 individuals in the UK Biobank

Nature
Volume 586 Issue 7831, 29 October 2020
http://www.nature.com/nature/current_issue.html

 

Article | 21 October 2020
Exome sequencing and characterization of 49,960 individuals in the UK Biobank
Exome sequences from the first 49,960 participants in the UK Biobank highlight the promise of genome sequencing in large population-based studies and are now accessible to the scientific community.
Cristopher V. Van Hout, Ioanna Tachmazidou[…] & Aris Baras

Evidence for 28 genetic disorders discovered by combining healthcare and research data

Nature
Volume 586 Issue 7831, 29 October 2020
http://www.nature.com/nature/current_issue.html

 

Article | 14 October 2020
Evidence for 28 genetic disorders discovered by combining healthcare and research data
By integrating healthcare and exome-sequencing data from parent–offspring trios of patients with developmental disorders, 28 genes that had not previously been associated with developmental disorders were identified.
Joanna Kaplanis, Kaitlin E. Samocha[…] & Kyle Retterer

Inherited causes of clonal haematopoiesis in 97,691 whole genomes

Nature
Volume 586 Issue 7831, 29 October 2020
http://www.nature.com/nature/current_issue.html

 

Article | 14 October 2020
Inherited causes of clonal haematopoiesis in 97,691 whole genomes
Analysis of 97,691 high-coverage human blood DNA-derived whole-genome sequences enabled simultaneous identification of germline and somatic mutations that predispose individuals to clonal expansion of haematopoietic stem cells, indicating that both inherited and acquired mutations are linked to age-related cancers and coronary heart disease.
Alexander G. Bick, Joshua S. Weinstock[…] & Pradeep Natarajan

The intersection of genomics and big data with public health: Opportunities for precision public health

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 31 Oct 2020)

 

Collection Review
The intersection of genomics and big data with public health: Opportunities for precision public health
Muin J. Khoury, Gregory L. Armstrong, Rebecca E. Bunnell, Juliana Cyril, Michael F. Iademarco
| published 29 Oct 2020 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1003373
Summary points
:: The field of precision public health (PPH) has emerged as a response to the increasing availability of genomics, biobanks, and other sources of big data in healthcare and public health.
:: The field has evolved starting with genomics to include multiple practical applications such as pathogen genomics that address population health.
:: PPH can expand understanding of health disparities, advance strategic public health science, and demonstrate the need for innovation and workforce development.
:: In the coronavirus disease 2019 (COVID-19) era, rapidly evolving scientific innovation can have a long-lasting impact on PPH beyond the pandemic.
:: Further developments in PPH will require global, national, and local leadership and stakeholder engagement.

Effectiveness of the 23-valent pneumococcal polysaccharide vaccine against vaccine serotype pneumococcal pneumonia in adults: A case-control test-negative design study

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 31 Oct 2020)

 

Effectiveness of the 23-valent pneumococcal polysaccharide vaccine against vaccine serotype pneumococcal pneumonia in adults: A case-control test-negative design study
Hannah Lawrence, Harry Pick, Vadsala Baskaran, Priya Daniel, Chamira Rodrigo, Deborah Ashton, Rochelle C. Edwards-Pritchard, Carmen Sheppard, Seyi D. Eletu, David Litt, Norman K. Fry, Samuel Rose, Caroline Trotter, Tricia M. McKeever, Wei Shen Lim
Research Article | published 23 Oct 2020 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1003326

Common childhood vaccines do not elicit a cross-reactive antibody response against SARS-CoV-2

PLoS One
http://www.plosone.org/

 

Research Article
Common childhood vaccines do not elicit a cross-reactive antibody response against SARS-CoV-2
Ahmed Kandeil, Mokhtar R. Gomaa, Ahmed El Taweel, Ahmed Mostafa, Mahmoud Shehata, Ahmed E. Kayed, Omnia Kutkat, Yassmin Moatasim, Sara H. Mahmoud, Mina Nabil Kamel, Noura M. Abo Shama, Mohamed El Sayes, Rabeh El-Shesheny, Mahmoud A. Yassien, Richard J. Webby, Ghazi Kayali, Mohamed A. Ali
Research Article | published 28 Oct 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0241471

Country-level pandemic risk and preparedness classification based on COVID-19 data: A machine learning approach

PLoS One
http://www.plosone.org/

 

Country-level pandemic risk and preparedness classification based on COVID-19 data: A machine learning approach
Jordan J. Bird, Chloe M. Barnes, Cristiano Premebida, Anikó Ekárt, Diego R. Faria
Research Article | published 28 Oct 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0241332

Opinion: For now, it’s unethical to use human challenge studies for SARS-CoV-2 vaccine development

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

 

Front Matter
Opinion: For now, it’s unethical to use human challenge studies for SARS-CoV-2 vaccine development
Jeffrey P. Kahn, Leslie Meltzer Henry, Anna C. Mastroianni, Wilbur H. Chen, and Ruth Macklin
PNAS first published October 29, 2020. https://doi.org/10.1073/pnas.2021189117

Fine-scale spatial clustering of measles nonvaccination that increases outbreak potential is obscured by aggregated reporting data

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

 

Fine-scale spatial clustering of measles nonvaccination that increases outbreak potential is obscured by aggregated reporting data
Nina B. Masters, Marisa C. Eisenberg, Paul L. Delamater, Matthew Kay, Matthew L. Boulton, and Jon Zelner
PNAS first published October 26, 2020. https://doi.org/10.1073/pnas.2011529117

Guaranteeing the Health Rights of People with Disabilities in the COVID-19 Pandemic: Perspectives from China

Risk Management and Healthcare Policy
https://www.dovepress.com/risk-management-and-healthcare-policy-archive56
[Accessed 31 Oct 2020]

 

Perspectives
Guaranteeing the Health Rights of People with Disabilities in the COVID-19 Pandemic: Perspectives from China
Qi F, Wang Q
Risk Management and Healthcare Policy 2020, 13:2357-2363
Published Date: 30 October 2020

The determinants of vaccine hesitancy in China: A cross-sectional study following the Changchun Changsheng vaccine incident

Vaccine
Volume 38, Issue 47 Pages 7409-7568 (3 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/47

 

Research article Abstract only
The determinants of vaccine hesitancy in China: A cross-sectional study following the Changchun Changsheng vaccine incident
Fanxing Du, Tracey Chantler, Mark R. Francis, Fiona Yueqian Sun, … Zhiyuan Hou
Pages 7464-7471

How acceptable is adolescent self-consent for the HPV vaccination: Findings from a qualitative study in south-west England

Vaccine
Volume 38, Issue 47 Pages 7409-7568 (3 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/47

 

Research article Open access
How acceptable is adolescent self-consent for the HPV vaccination: Findings from a qualitative study in south-west England
Suzanne Audrey, Michelle Farr, Marion Roderick, Karen Evans, Harriet Fisher
Pages 7472-7478

Utility of the Tétanos Quick Stick® in the vaccine catch-up of adult migrants without proof of prior vaccination

Vaccine
Volume 38, Issue 47 Pages 7409-7568 (3 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/47

 

Research article Abstract only
Utility of the Tétanos Quick Stick® in the vaccine catch-up of adult migrants without proof of prior vaccination
Sandrine Adeikalam, Hélène de Champs Léger, Nicolas Vignier, Sophie Grabar, Dominique Salmon
Pages 7517-7525

Immunogenicity of seasonal inactivated influenza and inactivated polio vaccines among children in Senegal: Results from a cluster-randomized trial

Vaccine
Volume 38, Issue 47 Pages 7409-7568 (3 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/47

 

Research article Abstract only
Immunogenicity of seasonal inactivated influenza and inactivated polio vaccines among children in Senegal: Results from a cluster-randomized trial
Mbayame Niang, Meagan E. Deming, Deborah Goudiaby, Ousmane M. Diop, … Kathleen M. Neuzil
Pages 7526-7532

Vaccine Prices: A Systematic Review of Literature

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 31 Oct 2020)

 

Open Access Review
Vaccine Prices: A Systematic Review of Literature
by Rabia Hussain, Nadeem Irfan Bukhari, Anees ur Rehman, Mohamed Azmi Hassali and Zaheer-Ud-Din Babar
Vaccines 2020, 8(4), 629; https://doi.org/10.3390/vaccines8040629 – 29 Oct 2020
Abstract
Vaccines are among the most vital interventions to control and reduce the morbidity and mortality worldwide. In accessing vaccines, pricing is usually the single most important deciding element. However, there is a scarcity of the literature on the vaccines pricing. The current study aims to review vaccine prices from the published literature and to evaluate factors that impact the pricing of vaccines. The literature (from 2015–2020) was reviewed to identify the original research articles. Systematic searches were conducted across the five databases including, Google Scholar, PubMed, Science Direct, Scopus and Springer Link. Literature search yielded 23,626 articles, of which 7351 were screened and 7310 articles were excluded based on title and abstracts relevance. The 41 studies were selected for full text review and 4 studies were found to meet the inclusion criteria. The included studies discussed vaccine prices for childhood vaccines, for Human Papilloma Virus (HPV) in US, China and in Europe. One study detailed the various scenarios of the HPV vaccines pricing. It was found that recently introduced vaccines have higher prices owing to the involvement of technology and research for their manufacture. However, prices tended to decrease over some maturation in price and by the involvement of Global Alliance for Vaccine Initiative (GAVI) and other allies. The prices of vaccines in China were much lower than the other high-income countries and the prices offered through United Nations Children’s Fund (UNICEF), mainly due to the large scale of demand in China. The affordable prices of vaccines were related to delicate procedures involving multiple stakeholders and a shorter duration of contract. This review systematically evaluated the literature and identified key factors that could impact vaccines pricing. The prices were higher for the newly introduced vaccines into the market. However, with the price maturation, there was a decline in the pricing and affordable prices could be achieved through tender pricing and involvement of GAVI and other allies

Value Frameworks for Vaccines: Which Dimensions Are Most Relevant?

Open Access Article
Value Frameworks for Vaccines: Which Dimensions Are Most Relevant?
by Jeroen Luyten, Roselinde Kessels, Corinne Vandermeulen and Philippe Beutels
Vaccines 2020, 8(4), 628; https://doi.org/10.3390/vaccines8040628 – 28 Oct 2020
Viewed by 197
Abstract
In addition to more narrow criteria such as safety, effectiveness and cost-effectiveness, vaccines can also be evaluated based on broader criteria such as their economic impact, contribution to disease eradication objectives, caregiver aspects, financial protection offered, equity or social acceptability. We summarize a survey executed in a sample of the population (n = 1000) in Flanders, Belgium, in which we investigated support for using these broader criteria to evaluate vaccines for funding decisions. By means of both favourable and unfavourable framings of a hypothetical vaccine across 40 value dimensions, we find support for the view that people indeed consider a broad range of medical and socio-economic criteria relevant. Several of these are not incorporated in standard evaluation frameworks for vaccines. The different results we find for different framings highlight the importance of developing a consistent a priori value framework for vaccine evaluation, rather than evaluating vaccines on an ad hoc basis.

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 31 Oct 2020)

 

Open Access Article
Value Frameworks for Vaccines: Which Dimensions Are Most Relevant?
by Jeroen Luyten, Roselinde Kessels, Corinne Vandermeulen and Philippe Beutels
Vaccines 2020, 8(4), 628; https://doi.org/10.3390/vaccines8040628 – 28 Oct 2020
Viewed by 197
Abstract
In addition to more narrow criteria such as safety, effectiveness and cost-effectiveness, vaccines can also be evaluated based on broader criteria such as their economic impact, contribution to disease eradication objectives, caregiver aspects, financial protection offered, equity or social acceptability. We summarize a survey executed in a sample of the population (n = 1000) in Flanders, Belgium, in which we investigated support for using these broader criteria to evaluate vaccines for funding decisions. By means of both favourable and unfavourable framings of a hypothetical vaccine across 40 value dimensions, we find support for the view that people indeed consider a broad range of medical and socio-economic criteria relevant. Several of these are not incorporated in standard evaluation frameworks for vaccines. The different results we find for different framings highlight the importance of developing a consistent a priori value framework for vaccine evaluation, rather than evaluating vaccines on an ad hoc basis.

Media/Policy Watch

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

 

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 31 Oct 2020
[No new, unique, relevant content]

 

BBC
http://www.bbc.co.uk/
Accessed 31 Oct 2020
[No new, unique, relevant content]

 

The Economist
http://www.economist.com/
Accessed 31 Oct 2020
[No new, unique, relevant content]

 

Financial Times
https://www.ft.com/
Accessed 31 Oct 2020
Moderna rakes in over $1bn in deposits for potential Covid vaccine
…Moderna has received more than $1bn in deposits from governments for its potential Covid-19 vaccine, highlighting how the pandemic has transformed the fortunes of the lossmaking US biotech.
October 29, 2020

 

Forbes
http://www.forbes.com/
Accessed 31 Oct 2020
Oct 30, 2020
Report Details ‘Shocking’ Outbreaks Of Mumps, Influenza, And Chickenpox In ICE Detention Centers
Rare infections are spreading in ICE centers that have crowded conditions and poor access to healthcare.
By Robert Hart Forbes Staff

Oct 29, 2020
The FDA Will Not Inspect Vaccine Production Plants
Approval of a vaccine by the Food and Drug Administration (FDA) typically requires inspection of the vaccine’s manufacturing plants. In a Covid-19 world, this will not be the case. Covid-19 vaccine candidates will get a pass on FDA plant inspections, according to Bloomberg.
By William A. Haseltine Contributor

Oct 29, 2020
Fauci Endorses National Mask Mandate But Concedes It’s Unlikely Under Trump
The nation’s top infectious disease official says he hasn’t spoken about the outbreak with President Trump in ‘quite a while.’
By Andrew Solender Forbes Staff

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 31 Oct 2020
[No new, unique, relevant content]

 

Foreign Policy
http://foreignpolicy.com/
Accessed 31 Oct 2020
[No new, unique, relevant content]

 

The Guardian
http://www.guardiannews.com/
Accessed 31 Oct 2020
[No new, unique, relevant content]

 

New Yorker
http://www.newyorker.com/
Accessed 31 Oct 2020
[No new, unique, relevant content]

 

New York Times
http://www.nytimes.com/
Accessed 31 Oct 2020
Asia Pacific
U.S. Says Virus Can’t Be Controlled. China Aims to Prove It Wrong.
China’s approach to keep Covid-19 at bay has helped restore confidence and allowed businesses to reopen. But it is a strategy steeped in authoritarianism.
By Javier C. Hernández Oct. 30

 

Washington Post
https://www.washingtonpost.com/
Accessed 31 Oct 2020
States say they lack federal funds to distribute coronavirus vaccine as CDC tells them to be ready
Lena H. Sun · Health · Oct 30, 2020

Think Tanks et al

Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 31 Oct 2020
TechStream
Will Americans trust a COVID-19 vaccine? Not if politicians tell them to.
Sarah Kreps and Douglas L. Kriner
Friday, October 30, 2020
…In a study of American attitudes toward COVID-19 vaccination, just published in the Journal of the American Medical Association Network Open, we found that Americans’ support for vaccination declines in the face of political involvement in the vaccine process…
 
 
Center for Global Development [to 31 Oct 2020]
http://www.cgdev.org/page/press-center
Event
COVID-19 Vaccine Predictions Part 2: Estimating the Time Before We Approve Efficacious
11/10/20
Much of the discussion around society’s ability to return to “normality” after the COVID-19 pandemic has centered on the development of a vaccine. This has led to unprecedented collaboration and investment.

Chatham House [to 31 Oct 2020]
https://www.chathamhouse.org/
[No new relevant content]

 

CSIS
https://www.csis.org/
Accessed 31 Oct 2020
Podcast Episode
Delivering Vaccines to Americans: Cause for Alarm?
October 28, 2020 | By J. Stephen Morrison, H. Andrew Schwartz

 

Council on Foreign Relations
http://www.cfr.org/
Accessed 31 Oct 2020
[No new relevant content]

 
 
Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 31 Oct 2020
[No new relevant content]

Vaccines and Global Health: The Week in Review :: 24 October 2020

Vaccines and Global Health: The Week in Review is a weekly digest  summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date

.– Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

– pdf version A pdf of the current issue is available here: 

– blog edition: comprised of the approx. 35+ entries posted below.

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
.
– Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.

Support this knowledge-sharing service: Your financial support helps us cover our costs and to address a current shortfall in our annual operating budget. Click here to donate and thank you in advance for your contribution.

.
David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

COVID-19 Vaccines – Regulatory Milestones

Milestones :: Perspectives :: Research

 

COVID-19 Vaccines – Regulatory Milestones

 

Editor’s Note
Among the critical milestones in the development and regulatory review of candidate COVID-19 vaccines was the meeting earlier this week of the FDA’s Vaccines and Related Biological Products Advisory Committee. We are not aware that any summary report or notes have been released on this meeting but the webcast is now available at the link below. While the meeting runs 08:50 it is critical to appreciating what will come next in the COVID-19 vaccines journey.

FDA – Vaccines and Related Biological Products Advisory Committee 
10/22/2020
The Committee met in open session to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application was discussed at this meeting. View webcast

COVID-19 Vaccines – Access/Guiding Principles

Milestones :: Perspectives :: Research

 

COVID-19 Vaccines – Access/Guiding Principles

 

Editor’s Note
The “guiding principles” below take their place in a long line of formulations of access principles, various forms of “guidance”, ethical imperatives, and normative frameworks around distribution of and access to COVID-19 vaccines [as they become available] We cannot report seeing an orderly aggregation and analysis of these contributions to a very complex and evolving challenge. Readers are invited to alert us if they have encountered such an analysis or if they are working to development one!

Pharmaceutical Supply and Payment Chain Coalition Announces Guiding Principles for Safe, Efficacious Access to COVID-19 Vaccine
Washington, D.C. (October 22, 2020) — Today, representative organizations of America’s pharmaceutical supply and payment chain, including prescription and over-the-counter brand and generic manufacturers; pharmacies and pharmacists across all practice settings, including health systems and hospitals, community, specialty, and managed care; supermarkets; wholesalers; pharmaceutical quality standard developers; employers and other health plan sponsors; health insurance providers; and pharmacy benefit managers, released guiding principles for the safe efficacious development, distribution, and allocation of vaccine(s) to achieve mass immunization against the coronavirus (COVID-19)

The guiding principles represent the commitment of the private sector to the efficient, well-coordinated distribution, allocation, and mass immunization against COVID-19 as a necessary countermeasure to the current pandemic.

The strong and ongoing collaboration demonstrated by the pharmaceutical supply and payment chain has been essential for a host of issues important to Americans during the COVID-19 pandemic. The coalition looks forward to continuing to work together in the best interest of the individuals and families that we serve.

Academy of Managed Care Pharmacy (https://www.amcp.org/disease-state-resources/COVID-19-resources-managed-care-pharmacy)
America’s Health Insurance Plans (https://www.ahip.org/issues/coronavirus-COVID-19/)
American Pharmacists Association (http://www.pharmacist.com/coronavirus)
ASHP – American Society of Health-System Pharmacists (https://www.ashp.org/COVID-19)
Association for Accessible Medicines (https://accessiblemeds.org/COVID-19-FAQs)
Biotechnology Innovation Organization (https://www.bio.org/policy/human-health/vaccines-biodefense/coronavirus)
Blue Cross Blue Shield Association (https://www.bcbsprogresshealth.com/issues/addressing-the-covid-19-pandemic-with-care-and-compassion)
U.S. Chamber of Commerce (https://www.uschamber.com/coronavirus)
FMI – the Food Industry Association (https://www.fmi.org/coronavirus)
Healthcare Distribution Alliance (https://www.hda.org/issues/COVID19-response)
National Association of Chain Drug Stores, “Flu Shots, Regular Vaccine Schedules, Preparation for COVID-19 Vaccines” (https://www.nacds.org/COVID-19/)
National Association of Specialty Pharmacy (https://naspnet.org/COVID-19-resources/)
National Community Pharmacists Association, “Coronavirus Information” (https://ncpa.org/coronavirus-information)
National Grocers Association (https://www.nationalgrocers.org/news/national-grocers-association-coronavirus/)
Pharmaceutical Care Management Association  (https://www.pcmanet.org/COVID-19-how-pbms-are-helping-patients-and-health-plans/)
Pharmaceutical Research and Manufacturers of America (https://phrma.org/coronavirus)
U.S. Pharmacopeia (https://www.usp.org/COVID-19)

 

::::::

Guiding Principles for Safe and Efficacious COVID-19 Vaccine Development, Distribution, Allocation, and Mass Immunization
The efficient, well-coordinated distribution, allocation, and mass vaccination activities against the novel coronavirus (SARS-CoV-2) will help ensure vaccination is an effective countermeasure tothe current pandemic. High COVID-19 vaccination rates with an effective vaccine are essential to mitigating the pandemic now and protecting against future outbreaks.

The Pharmaceutical Supply and Payment Chain Coalition offers the following guiding principles
for the safe and efficacious development, distribution, and allocation of a vaccine(s) to achieve
coordinated mass vaccination against COVID-19:

:: COVID-19 vaccine development, approval, and post-marketing surveillance must adhere to transparent and scientifically rigorous processes that engender public trust in the safety and efficacy of these products. The U.S. Food & Drug Administration (FDA) is the global “gold standard” for the safety and efficacy of medical products. In addition to FDA, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has unparalleled experience and expertise in defining use considerations and guidelines for vaccines so they are used safely and effectively by hundreds of millions of people. Widespread confidence in all licensed or authorized COVID-19 vaccines is critical for individuals to choose to be vaccinated and to overcome vaccine hesitancy. In furtherance of this trust, the FDA should continue to facilitate timely access to vaccine pharmacovigilance data and other relevant safety
information as the vaccination process unfolds.

:: Equitable allocation of COVID-19 vaccine is paramount, and priority should be given to achieving the greatest public health impact. Decision-making about who should be granted priority access to the initial supply of COVID-19 vaccine(s) must be transparent, comprehensive, inclusive, and adhere to the highest possible ethical standards. Timely national dialogue, through multiple forms of community engagement, will encourage public trust in fair vaccine allocation and distribution strategies.

:: Consistent public engagement and clear communication on initial and subsequent prioritization decisions by ACIP will be needed. Public health officials recognize that initial supply and subsequent availability may be insufficient for the vaccination of all priority groups. Decision-making processes for subsequent prioritization by ACIP must adhere to the same high standards and transparent processes as initial decisions. Vaccine selection and immunization decisions should continue to be made based on updated evidence of vaccine effectiveness, including evidence demonstrating relative effectiveness for specific patient populations (e.g., pediatrics, pregnancy, older adults, patients with complex health conditions, and other sub-groups).

:: Distribution must be guided by a well-coordinated national strategy that is aligned with existing strategies for the distribution of routine vaccines. Deliberate planning at all levels of government and in collaboration with state and local public health stakeholders, and the private sector, will be necessary for appropriately executing national guidelines to the unique and changing needs of local communities. Distribution should leverage existing mechanisms and infrastructure; this includes ensuring equitable access and availability across the country, particularly in rural and underserved areas.

:: Vaccination program policies and deployment strategies must account for the readiness of local vaccination infrastructure and safety of the immunizer workforce. Policies and deployment strategies must ensure vaccinations are conducted under safe conditions, with the immunizer workforce and other essential health care workers prepared and protected from associated risk. As front-line health care workers, the immunizer workforce – consisting of pharmacists, physicians, nurses, pharmacy technicians, and other health care professionals – requires priority access to the initial vaccine supply. Those responsible for local vaccine infrastructure will need to adhere to the FDA-approved labeling instructions for each respective vaccine for proper storage and handling of vaccines throughout the supply chain. Strategies must also account for specific instructions for storage, handling, and administration of vaccines, including proper handling of sharps.

:: Vaccination for the prevention and management of infectious disease, including COVID-19, is a core health service that should be prioritized and promoted. Achieving high COVID-19 vaccinations rates will require minimizing vaccine hesitancy and misinformation and ensuring vaccines are administered properly and in accordance with national clinical guidance. Health care professionals, including pharmacists, will be relied on to provide patient education about vaccine options and safety, and manage patients with complex health care conditions. National clinical guidance for immunization providers should be issued and should include considerations for differing clinical application of various COVID-19 vaccines and where booster doses are needed to maintain efficacy. There also needs to be clear communication regarding how long the vaccine is effective and when individuals may need booster doses. A coordinated vaccine registry approach and record-keeping guidance, particularly to track vaccines requiring booster doses, also may be needed.

:: Ensuring affordability and access, including by preventing and removing financial barriers, will be critical to a successful public health response to COVID-19. Upon FDA licensure or authorization, and once recommendations are issued by ACIP, manufacturers, payors, physicians, pharmacists, and other critical stakeholders, such as community health centers, should promote broad access and affordability following national clinical guidance. ACIP should ensure that its recommendations are made immediately available so there is not a lag between the licensure or authorization decision and the ACIP recommendation. Reimbursement of immunization providers for reasonable administration fees is essential to maximizing access.

COVID 19 Vaccine Programs Update

Milestones :: Perspectives :: Research

 

COVID 19 Vaccine Programs Update

Moderna Completes Enrollment of Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273)
October 22, 2020
:: Moderna to make statement at today’s FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting
:: Moderna thanks PPD, its CRO partner, for the successful execution of COVE Study enrollment

 

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Canada’s Prime Minister, Justin Trudeau, Announced Today Precision NanoSystems Will Receive $18.2 Million from the Government of Canada to Develop an RNA Vaccine for COVID-19
:: PNI will use the investment to advance a cost-effective Made-in-Canada COVID-19 vaccine
:: PNI offers expertise in self-amplifying mRNA vectors, lipid-based drug delivery systems and nanomedicine manufacturing
:: PNI will contribute to Canada’s ability to secure an effective COVID-19 vaccine and build technologies towards enabling rapid response against future pandemics
Oct 23, 2020, 14:00 ET

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

EMERGENCIES

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

Weekly Epidemiological and Operational updates
last update: 8 October 2020, 20:00 GMT-4
Confirmed cases :: 42 055 863 [week ago: 39 023 292] [two weeks ago: 36 754 395]
Confirmed deaths :: 1 141 567 [week ago: 1 099 586] [two weeks ago: 1 064 838]
Countries, areas or territories with cases :: 218
Bottom of Form

WHO Director-General’s opening remarks at the media briefing on COVID-19 – 23 October 2020
:: We are at a critical juncture in this pandemic, particularly in the northern hemisphere. The next few months are going to be very tough and some countries are on a dangerous track.  We urge leaders to take immediate action, to prevent further unnecessary deaths, essential health services from collapsing and schools shutting again.
:: Oxygen is one of the most essential medicines for saving patients with COVID-19, and many other conditions. WHO is committed to working in solidarity with all governments, partners and the private sector to scale up sustainable oxygen supply.
:: Tomorrow marks World Polio Day week, and partners around the world – led in particular by Rotary International – are organising events and raising awareness about the need to eradicate polio.
:: Smallpox eradication is a remarkable achievement, not least because it was completed at the heart of the Cold War. Health did then and should now always come above politics and it is with sadness that this week we lost one of the great titans of smallpox eradication with the passing of Dr Mike Lane. We will continue to honour his legacy.
:: WHO is proud to announce the second Health for All Film Festival, to cultivate visual storytelling about public health.

Weekly epidemiological update – 20 October 2020
Global epidemiological situation
The incidence of new COVID-19 cases has continued to accelerate, while the incidence of new deaths has remained relatively stable (Figure 1). As of 18 October, over 40 million cases and 1.1 million deaths have been reported globally, with over 2.4 million new cases and 36 000 new deaths reported over the past week.

The European Region has continued to report a rapid increase in cases and deaths, with over 927 000 new cases reported this past week – a 25% weekly increase in cases compared to the previous week – contributing 38% of all new cases reported worldwide (Table 1). Similarly, the number of deaths continues to climb with a 29% increase from last week. Increases, although more gradual, were also observed in the African, Eastern-Mediterranean and Western Pacific Regions. Declines continued to be reported in the Region of the Americas and the South-East Asia Region; although the incidence of new infections remains high, and collectively these two regions contribute over half of new cases and deaths observed globally.

The countries reporting the highest number of cases in the past week remain the same as last week: India, the United States of America, France, Brazil and the United Kingdom.

Key weekly updates
:: Therapeutics: The Solidarity Therapeutics Trial have produced conclusive evidence on whether selected repurposed drugs are effective for COVID-19. Interim results from the Solidarity Therapeutics Trial, coordinated by WHO, indicate that remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens appear to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalised patients.
:: A call of Solidarity: Kim Sledge and the World We Want have partnered with WHO Foundation to re-record the unity anthem, “We Are Family”, in response to COVID-19 and to bring focus on global public health needs. A special edition cover of Sister Sledge’s hit “We Are Family” will be released in a new and inspiring call for global solidarity to respond to the COVID-19 pandemic and to generate proceeds to address the most pressing global health challenges of our time. In support of the song’s release, people worldwide are invited to submit videos of themselves singing We Are Family for inclusion in a compilation video for release on 7 December 2020.
:: Briefings: WHO Director-General Dr Tedros, in his regular media briefing on 12 October, expressed concern around the concept of reaching so-called “herd immunity” by the letting the virus spread – “never in the history of public health has herd immunity been used as a strategy for responding to an outbreak, let alone a pandemic. It is scientifically and ethically problematic”. Furthermore, in a media briefing on 16 October, Dr Tedros highlighted the rising number of cases of COVID-19 globally, especially in Europe where, although the number of deaths reported is much lower than in March, hospitalisations are increasing.
:: Health System Strengthening: WHO published a Handbook for public health capacity-building at ground crossings and cross-border collaboration. The objectives of the handbook are to introduce principles of strategic risk assessment for prioritizing preparedness and response capacity building; highlight issues to consider when selecting ground crossings for designation under the International Health Regulations (2005, IHR); and, support the establishment and maintenance of cross-border collaboration to improve coordination and communication.
:: Food security, public health and livelihoods: On 13 October, WHO with the International Labour Organization (ILO), Food and Agriculture Organization (FAO), and the International Fund for Agriculture Development (IFAD) released a joint statement on the Impact of COVID-19 on people’s livelihoods, their health and our food systems. The pandemic has been affecting the entire food system and has laid bare its fragility. Border closures, trade restrictions and confinement measures have been preventing farmers from accessing markets, including for buying inputs and selling their produce, and agricultural workers from harvesting crops, thus disrupting domestic and international food supply chains and reducing access to healthy, safe and diverse diets. According to the policy brief published by the United Nations, in the long run, we face possible disruptions to the functioning of food systems, with severe consequences for health and nutrition.

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POLIO Public Health Emergency of International Concern (PHEIC); WHO/OCHA Emergencies

Emergencies

 POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 21 October 2020
:: World Polio Day is around the corner! Observed on the 24 October, the theme for 2020 is “A win against polio is a win for global health.” Mark your calendar to tune in for Rotary International’s World Polio Day Online Global Update, streamed in multiple languages around the world.
:: On 19 September 2019, a polio outbreak was declared in the Philippines after a 3-year-old child and several environmental samples tested positive for polioviruses. Fifteen other children have been paralyzed by polio since the outbreak started. As we approach World Polio Day this year, we are celebrating the heroes who have been working tirelessly to combat polio in the Philippines.

Summary of new WPV and cVDPV viruses this week (AFP cases and environmental samples):
:: Afghanistan: one WPV1 case, one WPV1positive environmental sample, 14 cVDPV2 cases and 2 cVDPV2 positive environmental samples
:: Pakistan: two WPV1 cases and one WPV1 positive environmental sample
:: Benin: one cVDPV2 positive environmental sample
:: Burkina Faso: 21 cVDPV2 cases
:: Côte d’Ivoire: 15 cVDPV2 cases
:: Ethiopia: four cVDPV2 cases
:: Mali: six cVDPV2 case
:: Nigeria: one cVDPV2 case
:: Somalia: five cVDPV2 cases and one cVDPV2 positive environmental sample
:: Sudan: 16 cVDPV2 cases
:: Yemen: two cVDPV1 cases

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Statement of the Twenty-Sixth Polio IHR Emergency Committee
22 October 2020 Statement
The twenty-sixth meeting of the Emergency Committee under the International Health Regulations (2005) (IHR) on the international spread of poliovirus was convened and opened by the WHO Deputy Director-General on 14 October 2020 with committee members attending via video conference, supported by the WHO Secretariat.  Dr Zsuzsana Jakab in opening remarks on behalf of Dr Tedros congratulated all those involved in eliminating wild polioviruses from the WHO African Region despite some very challenging obstacles.  The COVID-19 pandemic and the ongoing spread of cVDPV2 were both growing major challenges, which would require strenuous efforts to overcome in order to restart progress toward global polio eradication.

The Emergency Committee reviewed the data on wild poliovirus (WPV1) and circulating vaccine derived polioviruses (cVDPV).  The following IHR States Parties provided an update at the video conference or in writing on the current situation in their respective countries: Afghanistan, Chad, Egypt, Guinea, Pakistan, Somalia, South Sudan, Sudan and Yemen.

Wild poliovirus
The higher incidence of global WPV1 cases seen during 2020 continues, with 121 cases reported between 1 January – 5 October 2020 compared to 85 for the same period in 2019, a 42% increase.  Last year there were 176 WPV1 cases, the highest number reported since the PHEIC was declared in 2014, when there were 359 cases in nine countries.  The lowest number of WPV1 cases was reported in 2017, when only 22 cases were found.  No wild polio cases have been detected outside of Pakistan and Afghanistan since the last cases in Nigeria in 2016 four years ago.  The number of positive environmental samples has increased 70% to 375 compared to 221 for the same time last year.  Since the last meeting, exportation of WPV1 from Pakistan to Afghanistan has been documented.

The Committee noted that based on results from sequencing of WPV1 since the last committee meeting in June, there were further instances of international spread of viruses from Pakistan to Afghanistan.  The ongoing frequency of WPV1 international spread between the two countries and the increased vulnerability in other countries where routine immunization and polio prevention activities have both been adversely affected by the COVID-19 pandemic are two major factors that suggest the risk of international spread may be at the highest level since 2014.  While border closures and lockdowns may mitigate the risk in the short term while in force, this would be outweighed in the longer term by falling population immunity through disruption of vaccination and the resumption of normal population movements.

On the other hand the certification of the WHO African Region as wild polio free in August 2020 indicated a lessening of the global risk from this previous source.

Vaccine derived poliovirus (VDPV)
The committee was very concerned that the international spread of cVDPV2 continues, causing new outbreaks in Guinea, South Sudan and Sudan, the latter two due to importation of a cVDPV2 lineage that emerged in Chad in 2019.  The same virus has also been detected in sewage in Cairo, Egypt but with no evidence of local circulation. The number of cases in 2020 is 409 as at 5 October 2020, already exceeding the 378 cases reported for the whole of 2019.  As in all other years after 2016 when OPV2 was withdrawn, the number of cVDPV2 cases has been greater than the number of WPV1 cases in 2020.  However, the number of sub-types / lineages detected so far in 2020 is 27, compared to 42 for the whole of 2019, and the number of newly emerged viruses is only seven so far this year, compared to 38 during 2019.

Cross border spread of cVDPV2 is now occurring regularly.  Based on analysis by the US CDC of isolates, in the three months from April to June 2020, there has been evidence of exportation of cVDPV2 from:
·     Pakistan to Afghanistan
·     Côte d’Ivoire to Mali
·     Guinea to Mali
·     Côte d’Ivoire to Ghana, and Ghana to Côte d’Ivoire
·     CAR to Cameroon
·     Chad to Sudan and South Sudan
·     Ghana to Burkina Faso

COVID-19
The committee heard that nearly all countries (90%) have experienced disruption to health services especially in low and middle income countries, according to a survey of 105 countries conducted March – June 2020.  Routine immunization particularly outreach services was the area most frequently reported as disrupted.

The committee was very concerned that most of the current outbreak countries have had to delay immunization responses in recent months, meaning that transmission is likely continuing unchecked.  Furthermore, there appear to be significant falls in surveillance indicators in many of the outbreak countries, such as drops in AFP reporting rates, and lesser drops in environmental sampling.  Vaccine management and supply has been significantly impacted.  More than 60 campaigns in 28 countries have been postponed since late February and early March. Vaccine supplies have been disrupted in many ways, with some quantities already in-country at risk of exceeding their expiry data and therefore unusable.  Some suppliers are reaching storage capacity and may well be forced to stop production.

Although the resumption of Supplementary Immunization Activities (SIAs) is now occurring, the waves of the pandemic are expected to fluctuate considerably from country to country and across the WHO Regions, so the program will need to adjust according to the COVID-19 situation for the foreseeable future.

Although in general surveillance processes are continuing, there are clear signs of a significant drop in AFP case reporting, including in endemic countries, some outbreak countries and some other non-infected high risk countries.

The committee noted that GPEI modeling indicated there is a risk of an exponential rise in the number of cVDPV2 infected districts in the African Region, leading to a 200% increase if response SIAs had not resumed. In addition to the risk of WPV1 geographical spread and intensification, cVDPV2 cases could rise exponentially in Pakistan and Afghanistan potentially reaching more the 3,500 cases without a resumption of immunization response.   Consequently, both Pakistan and Afghanistan are now implementing large scale mOPV2 campaigns and will continue with tOPV/mOPV2 until controlled. While there has been rapid spread, particularly in Afghanistan, expected exponential rise has been curtailed by the resumption of campaigns in July.

Conclusion
The Committee unanimously agreed that the risk of international spread of poliovirus remains a Public Health Emergency of International Concern (PHEIC) and recommended the extension of Temporary Recommendations for a further three months.  The Committee recognizes the concerns regarding the lengthy duration of the polio PHEIC, but concludes that the current situation is extraordinary, with clear ongoing and increasing risk of international spread and ongoing need for coordinated international response…

Based on the current situation regarding WPV1 and cVDPV, and the reports provided by affected countries, the Director-General accepted the Committee’s assessment and on 19 October 2020 determined that the situation relating to poliovirus continues to constitute a PHEIC, with respect to WPV1 and cVDPV.  The Director-General endorsed the Committee’s recommendations for countries meeting the definition for ‘States infected with WPV1, cVDPV1 or cVDPV3 with potential risk for international spread’, ‘States infected with cVDPV2 with potential risk for international spread’ and for ‘States no longer infected by WPV1 or cVDPV, but which remain vulnerable to re-infection by WPV or cVDPV’ and extended the Temporary Recommendations under the IHR to reduce the risk of the international spread of poliovirus, effective 19 October 2020.

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WHO Grade 3 Emergencies [to 24 Oct 2020]

Democratic Republic of the Congo – No new digest announcements identified
Mozambique floods – No new digest announcements identified
Nigeria – No new digest announcements identified
Somalia – No new digest announcements identified
South Sudan – No new digest announcements identified
Syrian Arab Republic – No new digest announcements identified
Yemen – No new digest announcements identified

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WHO Grade 2 Emergencies [to 24 Oct 2020]
Burkina Faso
:: Burkina Faso : les tradipraticiens de santé de la région du Sud-Ouest à l’école de …
21 octobre 2020

Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burundi – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Ethiopia – No new digest announcements identified
Iran floods 2019 – No new digest announcements identified
Iraq – No new digest announcements identified
Libya – No new digest announcements identified
Malawi Floods – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Mozambique – No new digest announcements identified
Myanmar – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

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WHO Grade 1 Emergencies [to 24 Oct 2020]

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

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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: Recent Developments in Northwest Syria – Situation Report No. 21 – As of 20 October 2020

Yemen – No new digest announcements identified

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UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
COVID-19
::   Coronavirus disease 2019 (COVID-19) Situation Report 49: occupied Palestinian territory, issued 22 October 2020, information for period: 5 March – 22 October 2020

East Africa Locust Infestation
:: Desert Locust situation update – 19 October 2020

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WHO & Regional Offices [to 24 Oct 2020]

WHO & Regional Offices [to 24 Oct 2020]
23 October 2020 Departmental news
New book calls on world leaders to unite in response to health threats

23 October 2020 News release
Steroids boost survival of preterm babies in low-resource settings, new study finds

22 October 2020 News release
The World Health Organization and Wikimedia Foundation expand access to trusted information about COVID-19 on Wikipedia

22 October 2020 Statement
Statement of the Twenty-Sixth Polio IHR Emergency Committee

22 October 2020 Departmental news
New Study 31/A5349 on the treatment of drug-susceptible TB

21 October 2020 Departmental news
INFOSAN Quarterly Summary, 2020 #3

21 October 2020 News release
Call for entries: 2nd WHO Health for All Film Festival

20 October 2020 Departmental news
WHO 2020 Global TB Report app – now available in English, French and Russian

19 October 2020 News release
Kim Sledge and the World We Want partner with WHO Foundation to re-record unity anthem “We Are Family” in response to COVID-19 and to focus on global public health needs

16 October 2020 Departmental news
Strategic exchange with representatives from civil society and communities

 

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WHO Strategic Advisory Group of Experts on immunization (SAGE) : Request for nominations
16 October 2020
WHO is soliciting proposals for nominations of two new experts to serve on its Strategic Advisory Group of Experts (SAGE) on immunization. Deadline for applications: 22 November 2020
The new SAGE members’ appointment, for an initial period of three years, is scheduled for the first quarter of 2021.
WHO is seeking nominations particularly from the WHO South-East Asia and Western-Pacific Regions. Nominations of women and persons from low- and middle-income countries are specifically encouraged. A track record of achievements on implementation research and social sciences would be of particular relevance…

 

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Weekly Epidemiological Record, 23 October 2020, vol. 95, 43 (pp. 509–524)
Global programme to eliminate lymphatic filariasis: progress report, 2019

 

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Benin boosts COVID-19 response with increased testing 23 October 2020
:: Testing at the core of Gabon’s COVID-19 battle 23 October 2020

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
:: 19 October 2020 News release
Need to continue extreme caution against COVID-19: WHO
The World Health Organization today cautioned against any relaxation of response actions following the recent slight decline in COVID-19 cases in South-East Asia Region…

WHO European Region EURO
:: Epidemiologist Sergiu Sîngeorzan: “COVID-19 has taught people to wash their hands” 23-10-2020
:: United Nations at 75: bringing humanity together for a better tomorrow 23-10-2020
:: World Polio Day: walking the last mile together towards polio eradication 23-10-2020
:: Obesity significantly increases chances of severe outcomes for COVID-19 patients 22-10-2020
:: Statement by the WHO Regional Director for Europe on the Nagorno-Karabakh conflict 22-10-2020

WHO Eastern Mediterranean Region EMRO
:: Dr Farima is unstoppable 22 October 2020

WHO Western Pacific Region
:: 20 October 2020 | Feature story
WHO: COVID-19 must not derail tobacco cessation efforts
Many smokers in the Western Pacific Region have been prompted by coronavirus disease 2019 (COVID-19) to kick the habit, but the pandemic has also brought fresh challenges for the fight against tobacco.

CDC/ACIP [to 24 Oct 2020]

CDC/ACIP [to 24 Oct 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html

Advisory Committee on Immunization Practices (ACIP)
Webcast October 28-30, 2020
Meeting is a virtual meeting. No registration is required.
Meeting time, 10:00am – 5:30pm EDT (times subject to change).
Webcast Linkexternal icon
Meeting Agendapdf icon [No COVID agenda items]

Latest News Releases, Announcements
CDC Media Telebriefing Transcript on Operation Warp Speed
Friday, October 23, 2020

Coronavirus Disease 2019 (COVID-19)
Selected Resources
:: Excess Deaths Associated with COVID-19, by Age and Race and Ethnicity – United States, January 26-October 3, 2020 Thursday, October 22, 2020
:: COVID-19 Case Investigation and Contact Tracing among Refugee, Immigrant, and Migrant (RIM) Populations: Important Considerations for Health Departments Thursday, October 22, 2020
:: Interim Guidance on Management of Coronavirus Disease 2019 (COVID-19) in Correctional and Detention Facilities Wednesday, October 21, 2020
:: Interim Operational Considerations for Public Health Management of Healthcare Workers Exposed to or Infected with COVID-19: non-US Healthcare Settings Wednesday, October 21, 2020
:: Interim Considerations for K-12 School Administrators for SARS-CoV-2 Testing Wednesday, October 21, 2020
:: Travel during the COVID-19 Pandemic Wednesday, October 21, 2020
:: Considerations for Monitoring and Evaluation of Mitigation Strategies Implemented in K-12 Schools Wednesday, October 21, 2020

MMWR News Synopsis Friday, October 23, 2020
:: Vaccination Coverage by Age 24 Months Among Children Born in 2016 and 2017 – National Immunization Survey-Child, United States, 2017-2019
:: Valley Fever (Coccidioidomycosis) Awareness — California, 2016–2017
:: Excess Deaths Associated with COVID-19, by Age and Race and Ethnicity — United States, January 26–October 3, 2020 (Early release October 20)
:: Association Between Social Vulnerability and a County’s Risk for Becoming a COVID-19 Hotspot — United States, June 1–July 25, 2020
:: Mitigating a COVID-19 Outbreak Among Major League Baseball Players — United States, 2020
:: First 100 persons with COVID-19 in Zambia, March 18–April 28, 2020
:: Rapid Adaptation of HIV Treatment Programs in Response to COVID-19 — Namibia, 2020

China CDC

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

 

National Health Commission of the People’s Republic of China
http://en.nhc.gov.cn/
News
Oct 24: Daily briefing on novel coronavirus cases in China
On Oct 23, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 28 new cases of confirmed infections.

China joining COVAX for equitable global access to COVID-19 vaccines: FM spokesperson
2020-10-22
BEIJING — China’s joining of COVAX is an important measure to uphold the concept of a shared community of health for all and fulfill its commitment on turning COVID-19 vaccines into a global public good, a foreign ministry spokesperson said on Oct 21.
“China is the largest economy supporting COVAX,” Zhao Lijian said at a daily press briefing, expressing the hope that China’s joining will motivate enterprises to increase their production capacity, ensure the output of vaccines, and promote the accessibility and affordability of vaccines in developing countries.
A total of 184 countries and economies have now joined COVAX, an international initiative aimed at ensuring equitable access to COVID-19 vaccines across the world, according to the World Health Organization Director-General Tedros Adhanom Ghebreyesus. China signed an agreement with Gavi, the Vaccine Alliance, officially joining COVAX on Oct. 8…

Trials of China’s vaccines make major progress
2020-10-21
No severe adverse effects reported in 60,000 recipients, science official says
No recipient o f China’s COVID-19 vaccine approved for emergency use has reported severe adverse effects, and no vaccine recipient who went to work in countries where the pandemic is still ongoing has been infected, officials said on Oct 20.
China currently has 13 vaccine candidates in clinical trials, of which three inactivated vaccines and one adenovirus vector vaccine are in phase three trials overseas, said Tian Baoguo, deputy head of the Department of Science and Technology for Social Development of the Ministry of Science and Technology.
About 60,000 volunteers have been inoculated with the four vaccine candidates currently in phase three trials, Tian said at a news briefing held by the Joint Prevention and Control Mechanism of the State Council…

Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 24 Oct 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
Mouse study uncovers links between unsung brain cells and Huntington’s disease — and possible path for human therapies
October 21, 2020
Astrocytes, once thought of as inert ‘brain glue,’ may turn out to be key players in Huntington’s and other neurodegenerative diseases.

News
New cell line lets researchers use CRISPR to reversibly switch off genes
October 20, 2020
‘CRISPR interference’ technique enables study of basic cell biology and disease in human stem cells

 

BARDA – U.S. Department of HHS [to 24 Oct 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

 

BMGF – Gates Foundation [to 24 Oct 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
OCTOBER 19, 2020
At 2020 Grand Challenges Annual Meeting, Bill & Melinda Gates Foundation and Grand Challenges Partners Announce New Initiatives to Advance Global Health Innovation
Researchers and scientists from around the world convene to accelerate R&D to address COVID-19 and other global health challenges

 

Bill & Melinda Gates Medical Research Institute [to 24 Oct 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

 

CARB-X [to 24 Oct 2020]
https://carb-x.org/
News
10.21.2020  |
CARB-X is funding Cellics Therapeutics to develop a novel macrophage nanosponge to prevent and treat sepsis
CARB-X is awarding up to US$3.94 million to Cellics Therapeutics, based in San Diego, CA, USA, to develop a new treatment for sepsis caused by drug-resistant Gram-positive and Gram-negative bacteria.

10.20.2020  |
CARB-X 2019-20 Annual Report: Record high awards and funding during its fiscal year in the race against drug-resistant bacteria
CARB-X closed out its 2019-20 fiscal year with a record number of awards and a list of solid achievements, ramping up its efforts to accelerate innovation to combat the spread of antibiotic resistant bacteria. During the fiscal year which ended July 31, 2020, CARB-X granted $127.5 million to product developers and issued 23 new awards to support the early development of novel antibacterial products – the highest number of new awards in any single year since CARB-X was launched in 2016. The achievement is just one of the highlights in CARB-X’s 2019-2020 Annual Report published today.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 24 Oct 2020]
http://cepi.net/
Latest News
USA joins CEPI to support the development of epidemic vaccines
A total of US$20 million will be provided to CEPI through USAID to support programmes advancing vaccines against emerging infectious diseases
Blog 23 Oct 2020

CEPI expands global manufacturing network, reserving manufacturing capacity for more than 1 billion doses of COVID-19 vaccines
CEPI has signed agreements with Biofabri (Spain) and GC Pharma (Republic of Korea) to reserve vaccine manufacturing capacity for more than 1 billion doses of COVID-19 vaccines designated by CEPI.
COVAX 21 Oct 2020

Two more laboratories join CEPI’s centralised network to standardise assessment of COVID-19 vaccines
The NIBSC and Q2 Solutions will work alongside five other laboratories, using the same testing reagents and following common protocols, for uniform evaluation and direct comparisons of COVID-19…
Blog 20 Oct 2020

 

EDCTP [to 24 Oct 2020]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
No new digest content identified.

 

Emory Vaccine Center [to 24 Oct 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 24 Oct 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Strengthening global collaboration on COVID-19 real-world evidence and observational studies
Last updated: 23/10/2020
Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate regulatory decision-making on COVID-19 treatments and vaccines during a workshop convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The workshop was co-chaired by Health Canada and the European Medicines Agency (EMA) and took place on 13 October 2020. Participants discussed the progress made in building international patient cohorts, pregnancy research, and vaccines surveillance and vigilance during the pandemic. The outcomes of the discussions are highlighted in the summary report, which has been published today.
Observational research can complement the knowledge gained through clinical trials to support the evaluation of potential therapeutics and vaccines against COVID-19. Real-world evidence generated by observational studies is fundamental to understanding the benefits and risks of medicines when used in clinical practice for the prevention and treatment of COVID-19.
Workshop participants shared their lessons learnt from ongoing COVID-19 observational studies based on real-world data in various countries and regions around the world. Studies derived from such data can provide information that is critical to understanding the benefits and risks of medicines in real-life use by patients and healthcare professionals. Closer collaboration between international regulators and information sharing in this area will benefit patients globally…

 

European Vaccine Initiative [to 24 Oct 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 24 Oct 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
October 23, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 23, 2020
:: On Thursday, the FDA approved Veklury (remdesivir), the first drug approved to treat COVID-19, for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.
:: The FDA consolidated existing resources for stakeholders to easily access information about drug and biologics development and manufacturing, including for products to diagnose, cure, mitigate, treat or prevent COVID-19 and for other critically needed products to treat symptoms of COVID-19 or to provide supportive care to those with COVID-19.
:: The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary which provides a quick look at facts, figures and highlights of the agency’s response efforts.

October 22, 2020 – FDA Approves First Treatment for COVID-19
Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval…

October 20, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 20, 2020

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

 

FDA – COVID-19 Vaccines [to 24 Oct 2020]
www.fda.gov/covid19vaccines
Upcoming Events
10/22/2020
Vaccines and Related Biological Products Advisory Committee 
The Committee will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting. View webcast

10/20/2020
Advisory Committee on COVID-19 Vaccines
Dr. Peter Marks provides an update on COVID-19 vaccines and discusses the upcoming Vaccines and Related Biological Products Advisory Committee meeting.

 

Fondation Merieux [to 24 Oct 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

 

Gavi [to 24 Oct 2020]
https://www.gavi.org/
News releases
No new digest content identified.

 

GHIT Fund [to 24 Oct 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.

 

Global Fund [to 24 Oct 2020]
https://www.theglobalfund.org/en/news/
News/Updates
No new digest content identified.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 24 Oct 2020]
https://www.glopid-r.org/news/
News
UKCDR seeks supplier for online, mixed-media platform to support COVID-19 researchers in low resource settings
21/10/2020
The UK Collaborative on Development Research (UKCDR) is seeking to commission a supplier to develop an online, mixed-media platform which will support coordination of researchers funded by the COVID-19 Research Coordination and Learning Initiative (COVID CIRCLE) partners, undertaking COVID-19 research relevant to low resource settings.
The platform will enable researchers to connect, identify synergies and opportunities for collaboration, facilitate information sharing and host an online resource hub.
This platform will support COVID CIRCLE’s broader ambitions to improve coordination and efficiency of research funding and practice, to increase the impact of research response to COVID-19 with a focus on low and middle-income countries. GloPID-R is partnering UKCDR for COVID CIRCLE.
The deadline for electronic copies of proposals is 23:30 GMT on November 1, 2020.

 

Hilleman Laboratories [to 24 Oct 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 24 Oct 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.

 

IAVI [to 24 Oct 2020]
https://www.iavi.org/newsroom
October 22, 2020
IAVI, Merck KGaA, Darmstadt, Germany, and Serum Institute of India Join Forces to Develop Monoclonal Antibodies for COVID-19 and Ensure Prompt and Equitable Global Access
:: Promising COVID-19 treatment being developed with equitable global access as a central goal.
:: Approach that is complementary to future COVID-19 vaccines.
:: Leverages each partner’s significant expertise, geographic footprint, and infrastructure.
:: Unique among ongoing partnerships for COVID-19 monoclonal antibodies, aims to ensure access to a class of innovative therapies that have, to date, been out of reach in low- and middle-income countries (LMICs).
PUNE, INDIA, and NEW YORK — OCTOBER 22, 2020 — Today, IAVI, a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, and Serum Institute of India Pvt. Ltd., a leading manufacturer of vaccines and biologics, announced an agreement with Merck KGaA, Darmstadt, Germany, a leading science and technology company, to develop SARS-CoV-2 neutralizing monoclonal antibodies (mAbs) co-invented by IAVI and Scripps Research as innovative interventions to address the COVID-19 pandemic.

The agreement builds on the advanced antibody discovery and optimization expertise of IAVI and Scripps Research, gained from years of experience in HIV broadly neutralizing antibody research and development, and on Merck KGaA, Darmstadt, Germany’s and Serum Institute’s significant capabilities in design and scale up of accelerated manufacturing processes for mAb production. The global development plan is being led by the three organizations in partnership.

The two companies have broad networks across complementary geographic areas that will be crucial to reach given the worldwide spread of COVID-19. If the highly potent and broadly cross-reactive SARS-CoV-2 neutralizing antibody candidates being advanced through this partnership are shown to be efficacious in clinical trials, either as a single antibody or a potential combination of both candidates, Merck KGaA, Darmstadt, Germany will lead commercialization in developed countries. Serum Institute has a proven track record of more than 50 years in developing affordable medicines and is the world’s largest producer of vaccines. Serum Institute will lead global manufacturing as well as commercialization in low- and middle-low-income countries, including India…

 

 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
No new digest content identified.

 

 

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
Global Roadmap for Tailored Clinical Biosimilar Development: Instrumental for Sustainable Access to Biologics (24 September 2020)
Following its first peer-reviewed scientific paper on biosimilar medicines development: the Path Towards Tailored Clinical Biosimilar Development (Biodrugs), the International Generic and Biosimilar medicines Association (IGBA), which represents global manufacturers of generic and biosimilar medicines, today released a new policy…

 

 

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

 

IFRC [to 24 Oct 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Europe
Red Cross warns: Vigilance needed as Europe’s intensive care beds fill up
IFRC has warned people not to take their foot off the brake as hospital intensive care units in many cities across Europe near capacity.
22 October 2020

Vietnam
Five million swamped by catastrophic floods in Vietnam
Kuala Lumpur/Hanoi/Geneva, October 20, 2020 – Red Cross is ramping up relief as catastrophic floods have affected five million people in central Vietnam. At least 178,000 homes have been submerged in floodwaters that h …
20 October 2020

 

IRC International Rescue Committee [to 24 Oct 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
As COVID-19 increases global food insecurity, less children are receiving nutrition support across conflict-affected states
October 22, 2020

Press Release
Civilian deaths in Sahel states increase 1,870 percent as military response fails to stop violence and humanitarian needs spike, warns IRC
October 20, 2020

 

IVAC [to 24 Oct 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
World Pneumonia Day Panel Discussion
October 2020
On November 13th from 10am to 11:30am EST, join us for a panel discussion on “Maintaining Progress on Childhood Pneumonia in the COVID-19 Era.” Pneumonia claims the lives of more young children than any other disease – over 800,000 children under 5 each year worldwide are lost to this largely preventable infectious disease. The COVID-19 […]

 

IVI [to 24 Oct 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

 

JEE Alliance [to 24 Oct 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 24 Oct 2020]
http://www.msf.org/
Latest [Selected Announcements]
Mediterranean migration
Lives on the line as legal appeal lodged to free the Sea-Watch 4
Press Release 23 Oct 2020

South Sudan
Worsening flooding increases health risks
Project Update 22 Oct 2020

Iraq
Humanitarians behind the scenes in Iraq
Voices from the Field 20 Oct 2020

 

National Vaccine Program Office – U.S. HHS [to 24 Oct 2020]
https://www.hhs.gov/vaccines/about/index.html
No new digest content identified.

 

NIH [to 24 Oct 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
No new digest content identified.

 

PATH [to 24 Oct 2020]
https://www.path.org/media-center/
Press Releases
PATH at the 51st Union World Conference on Lung Health
October 20, 2020 by PATH
Tuberculosis (TB) continues to be the leading cause of death from an infectious agent, more than 25 years after the World Health Organization declared it a global emergency. COVID-19 has rightly drawn the world’s attention, but the pandemic will likely increase the number of deaths from TB due to interruptions in services, particularly detection and treatment.
Join PATH at this year’s virtual Union Conference as we discuss our work in TB control and our vision for reimagining TB care to be more patient-centered and resilient, even amidst a pandemic.

 

Sabin Vaccine Institute [to 24 Oct 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 24 Oct 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
21 October 2020
Community-led campaign encourages people living with HIV to start treatment
A new community-led public information campaign, It is in Your Power to, aimed at encouraging people living with HIV to start antiretroviral therapy has been launched in the four largest areas of the Russian Federation.

20 October 2020
51st Union World Conference on Lung Health opens today as gains in reducing TB deaths risk being set back by COVID-19
The 51st Union World Conference on Lung Health opened today under the theme “Advancing Prevention”. In light of the COVID-19 pandemic, the conference is taking place virtually for the first time in its 100-year history

 

UNICEF [to 24 Oct 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Press release
10/22/2020
Over 1.5 million children at risk due to floods in central Viet Nam – UNICEF
The children’s agency is allocating an immediate $100,000 for emergency relief

Statement
10/22/2020
UNICEF Executive Director Henrietta Fore’s remarks at the Conference on Sustaining Support for the Rohingya Refugee Response
Checked against delivery

Statement
10/20/2020
‘Toxic brew’ of instability, armed violence, extreme poverty, hunger and COVID-19 putting the future of an entire generation of children and young people in the Central Sahel at risk
UNICEF Executive Director Henrietta Fore’s remarks at the Ministerial Roundtable Meeting on the humanitarian situation in the Central Sahel Region

Press release
10/19/2020
1 in 6 children lives in extreme poverty, World Bank-UNICEF analysis shows
The pre-COVID-19 analysis reveals that 356 million children struggle to survive on less than $1.90 a day, two-thirds of them in sub-Saharan Africa

Press release
10/19/2020
UNICEF to stockpile over half a billion syringes by year end, as part of efforts to prepare for eventual COVID-19 vaccinations
Initial preparatory work – in partnership with Gavi and WHO – will include purchasing boxes for the safe disposal of syringes and mapping out cold chain equipment to ensure delivery of effective vaccines
NEW YORK, 19 October 2020 – As the world awaits a COVID-19 vaccine, UNICEF has begun laying the groundwork for the rapid, safe and efficient delivery of the eventual vaccine by purchasing and pre-positioning syringes and other necessary equipment.
As soon as COVID-19 vaccines successfully emerge from trials and are licensed and recommended for use, the world will need as many syringes as doses of vaccine. To begin preparations, this year, UNICEF will stockpile 520 million syringes in its warehouses, part of a larger plan of 1 billion syringes by 2021, to guarantee initial supply and help ensure that syringes arrive in countries before the COVID-19 vaccines.
During 2021, assuming there are enough doses of COVID-19 vaccines, UNICEF anticipates delivering over 1 billion syringes to support COVID-19 vaccination efforts on top of the 620 million syringes that UNICEF will purchase for other vaccination programmes against other diseases such as measles, typhoid and more.
“Vaccinating the world against COVID-19 will be one of the largest mass undertakings in human history, and we will need to move as quickly as the vaccines can be produced,” said Henrietta Fore, UNICEF Executive Director. “In order to move fast later, we must move fast now. By the end of the year, we will already have over half a billion syringes pre-positioned where they can be deployed quickly and cost effectively. That’s enough syringes to wrap around the world one and a half times.” 
In line with the longstanding collaboration between the two partners, Gavi will reimburse UNICEF for the procurement of the syringes and safety boxes, which shall then be used for the COVID-19 Vaccine Global Access Facility (COVAX Facility) and for other Gavi-funded immunization programmes if necessary…

 

Unitaid [to 24 Oct 2020]
https://unitaid.org/
Featured News
No new digest content identified.

 

Vaccination Acceptance Research Network (VARN) [to 24 Oct 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 24 Oct 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 24 Oct 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
Vaccine Update for Providers
October 2020
:: December 2020 event Registration is now open for the Dec. 9, 2020, Current Issues in Vaccines webinar. Dr. Offit’s presentation will be an Update on SARS-CoV-2 vaccines
The event will start at noon ET, and free continuing education credits will be offered for the live and archived event (CME, CEU, and CPE).

 

Wellcome Trust [to 24 Oct 2020]
https://wellcome.ac.uk/news
Opinion | 20 October 2020
Wellcome’s bold ambitions to improve health through our new strategy
Jeremy Farrar, Director, Wellcome
Today, I’m delighted to introduce a new vision and strategy for Wellcome that I hope will have significant positive impacts on the course of human health over the next two decades.

 

The Wistar Institute [to 24 Oct 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

 

WFPHA: World Federation of Public Health Associations [to 24 Oct 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.

 

World Organisation for Animal Health (OIE) [to 24 Oct 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 24 Oct 2020]
https://alliancerm.org/press-releases/
Press Releases
The Alliance for Regenerative Medicine Announces Election of 2021 Officers, Executive Committee, and Board of Directors
October 21, 2020

 

BIO [to 24 Oct 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 24 Oct 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 24 Oct 2020]
https://internationalbiotech.org/
News
No new digest content identified.

 

IFPMA [to 24 Oct 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA launches Note for Guidance to help those acting on behalf of biopharmaceutical companies live
GENEVA, 22 October 2020: The International Association of Pharmaceutical Manufacturers and Associations (IFPMA) published today a Note for Guidance on how to foster ethical relationships with third party intermediaries in the biopharmaceutical sector. IFPMA’s mission rests on the establishment and promotion of ethical principles for the industry as a whole and anyone acting on its behalf, in line with societal expectations.

Third party intermediaries play an important role in supporting the activity of biopharmaceutical companies and in improving ongoing access for patients and healthcare professionals to innovative, reliable and effective medicines and vaccines. They can operate as clinical research organizations, distributors, wholesalers, distribution or sales agents, consultants, brokers, commission agents, and/or independent sales representatives. They serve an integral role in the biopharmaceutical sector and health systems and therefore hold a critical mission to act with fairness and foster patient trust.

The Note for Guidance aims to complement the 2019 IFPMA Code of Practice and provides best practices for companies when working with third party intermediaries, such as adopting a dedicated risk management program as part of their overall compliance program and code of ethics. This would include, among others, identifying whether there is a particular risk profile for corruption, based on a review of the intermediary’s internal policies and controls for bribery or all types of corruption. This should cover common business activities such as travel/accommodation, gifts, hospitality, sponsorship or grants, sales and marketing, procurement processes, and many more…

Position Paper – Best Practices for In-Country Testing and Sample Management
22 October 2020

 

PhRMA [to 24 Oct 2020]
http://www.phrma.org/
Selected Press Releases, Statements
Press Release
Pharmaceutical Supply and Payment Chain Coalition Announces Guiding Principles for Safe, Efficacious Access to COVID-19 Vaccine
October 22, 2020
[See COVID-19 Vaccines above for detail]

Journal Watch

Journal Watch
Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focu-s on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.
If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

How Do We Combat Bogus Medicines in the Age of the COVID-19 Pandemic?

American Journal of Tropical Medicine and Hygiene
Volume 103, Issue 4, October 2020
http://www.ajtmh.org/content/journals/14761645/103/4

 

Perspective Piece
oa Accelerating Clinical Evaluation of Repurposed Combination Therapies for COVID-19
Craig R. Rayner, Louis Dron, Jay J. H. Park, Eric H. Decloedt, Mark F. Cotton, Vis Niranjan, Patrick F. Smith, Michael G. Dodds, Fran Brown, Gilmar Reis, David Wesche and Edward J. Mills
Pages: 1364–1366
https://doi.org/10.4269/ajtmh.20-0995

oa Polio in Afghanistan: The Current Situation amid COVID-19
Attaullah Ahmadi, Mohammad Yasir Essar, Xu Lin, Yusuff Adebayo Adebisi and Don Eliseo Lucero-Prisno III
Pages: 1367–1369
https://doi.org/10.4269/ajtmh.20-1010

How Do We Combat Bogus Medicines in the Age of the COVID-19 Pandemic?
Wubshet Tesfaye, Solomon Abrha, Mahipal Sinnollareddy, Bruce Arnold, Andrew Brown, Cynthia Matthew, Victor M. Oguoma, Gregory M. Peterson and Jackson Thomas
Pages: 1360–1363
https://doi.org/10.4269/ajtmh.20-0903

Maternal Influenza A(H1N1) Immunization During Pregnancy and Risk for Autism Spectrum Disorder in Offspring – A Cohort Study

Annals of Internal Medicine
20 October 2020 Volume 173, Issue 8
http://annals.org/aim/issue

 

Original Research
Maternal Influenza A(H1N1) Immunization During Pregnancy and Risk for Autism Spectrum Disorder in Offspring – A Cohort Study
Jonas F. Ludvigsson, MD, PhD, Henric Winell, MSc, Sven Sandin, PhD, Sven Cnattingius, MD, hD, … et al.
Influenza vaccination during pregnancy benefits maternal health. This analysis of Swedish national health registry data examined the risks for autism spectrum disorder among offspring of mothers who received influenza A(H1N1)pdm09 vaccination during pregnancy.

How to Quantify and Interpret Treatment Effects in Comparative Clinical Studies of COVID-19

Annals of Internal Medicine
20 October 2020 Volume 173, Issue 8
http://annals.org/aim/issue

 

Research and Reporting Methods
How to Quantify and Interpret Treatment Effects in Comparative Clinical Studies of COVID-19
FREE
Zachary R. McCaw, PhD, Lu Tian, ScD, Jason L. Vassy, MD, MPH, Christine Seel Ritchie, MD, MSPH, … et al.
Trials evaluating treatments for COVID-19 often use the time to a positive outcome as a key end point. In the presence of death as a competing risk, commonly used survival analysis techniques may not be appropriate. This article discusses issues with the current practice and presents alternative, more clinically interpretable approaches.

Vaccine Safety in Pregnancy: Going Beyond the Perinatal Period

Annals of Internal Medicine
20 October 2020 Volume 173, Issue 8
http://annals.org/aim/issue

 

Editorials
Vaccine Safety in Pregnancy: Going Beyond the Perinatal Period
Anders Hviid, MSc, DrMedSci
Ludvigsson and colleagues looked for an association between influenza A(H1N1)pdm09 vaccination during pregnancy and autism in offspring. The editorialist discusses how this study contributes to vaccine safety evaluation.

COVID-19 Clinical Trials: A Teachable Moment for Improving Our Research Infrastructure and Relevance

Annals of Internal Medicine
20 October 2020 Volume 173, Issue 8
http://annals.org/aim/issue

COVID-19 Clinical Trials: A Teachable Moment for Improving Our Research Infrastructure and Relevance
FREE

 

Stephen E. Kimmel, MD, MSCE, Robert M. Califf, MD, MACC, Natalie E. Dean, PhD, … et al.
This commentary posits the need for rapid evaluation of COVID-19 therapies as an inflection point spurring a much-needed rethinking of our research enterprise.

Influenza Vaccine: Routine Secondary Prevention for Patients With Cardiovascular Disease?

Annals of Internal Medicine
20 October 2020 Volume 173, Issue 8
http://annals.org/aim/issue

Influenza Vaccine: Routine Secondary Prevention for Patients With Cardiovascular Disease?
Chandini Raina MacIntyre, MBBS Hons 1, PhD

 

Chow and colleagues confirmed that cardiovascular events contribute to influenza-associated morbidity and mortality. The editorialist discusses why clinicians should consider influenza vaccination routine secondary prevention for cardiovascular morbidity and mortality.