Monthly Archives: November 2020

Efficacy, immunogenicity, and safety of a plant-derived, quadrivalent, virus-like particle influenza vaccine in adults (18–64 years) and older adults (≥65 years): two multicentre, randomised phase 3 trials

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The Lancet
Nov 07, 2020 Volume 396 Number 10261 p1463-1534, e73-e82
https://www.thelancet.com/journals/lancet/issue/current

 

Articles
Efficacy, immunogenicity, and safety of a plant-derived, quadrivalent, virus-like particle influenza vaccine in adults (18–64 years) and older adults (≥65 years): two multicentre, randomised phase 3 trials
Brian J Ward, et al

Lessons learnt from easing COVID-19 restrictions: an analysis of countries and regions in Asia Pacific and Europe

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The Lancet
Nov 07, 2020 Volume 396 Number 10261 p1463-1534, e73-e82
https://www.thelancet.com/journals/lancet/issue/current

 

Health Policy
Lessons learnt from easing COVID-19 restrictions: an analysis of countries and regions in Asia Pacific and Europe
Emeline Han, et al
Summary
The COVID-19 pandemic is an unprecedented global crisis. Many countries have implemented restrictions on population movement to slow the spread of severe acute respiratory syndrome coronavirus 2 and prevent health systems from becoming overwhelmed; some have instituted full or partial lockdowns. However, lockdowns and other extreme restrictions cannot be sustained for the long term in the hope that there will be an effective vaccine or treatment for COVID-19. Governments worldwide now face the common challenge of easing lockdowns and restrictions while balancing various health, social, and economic concerns. To facilitate cross-country learning, this Health Policy paper uses an adapted framework to examine the approaches taken by nine high-income countries and regions that have started to ease COVID-19 restrictions: five in the Asia Pacific region (ie, Hong Kong [Special Administrative Region], Japan, New Zealand, Singapore, and South Korea) and four in Europe (ie, Germany, Norway, Spain, and the UK). This comparative analysis presents important lessons to be learnt from the experiences of these countries and regions. Although the future of the virus is unknown at present, countries should continue to share their experiences, shield populations who are at risk, and suppress transmission to save lives.

The International Hundred Thousand Plus Cohort Consortium: integrating large-scale cohorts to address global scientific challenges

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Lancet Digital Health
Nov 2020 Volume 2 Number 11 e561-e628
https://www.thelancet.com/journals/landig/issue/current

 

Comment
The International Hundred Thousand Plus Cohort Consortium: integrating large-scale cohorts to address global scientific challenges
Teri A Manolio, Peter Goodhand, Geoffrey Ginsburg
…Leaders of large-scale cohorts, with support from the National Institutes of Health and the Wellcome Trust, and in collaboration with the Global Alliance for Genomics and Health (GA4GH) and the Global Genomic Medicine Collaborative (G2MC), have come together to form the International Hundred Thousand Plus Cohort Consortium (IHCC). As of May, 2020, IHCC comprises 103 cohorts in 43 countries involving nearly 50 million participants (figure, appendix). Collaborative efforts to date have focused on developing a queryable cohort registry and data sharing platform, identifying and piloting high-priority scientific projects, and developing a charter and governance structure to foster collaborations…

Projected health-care resource needs for an effective response to COVID-19 in 73 low-income and middle-income countries: a modelling study

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Lancet Global Health
Nov 2020 Volume 8 Number 11 e1352-e1443
http://www.thelancet.com/journals/langlo/issue/current

 

Articles
Projected health-care resource needs for an effective response to COVID-19 in 73 low-income and middle-income countries: a modelling study
Tessa Tan-Torres Edejer, et al.
Since WHO declared the COVID-19 pandemic a Public Health Emergency of International Concern, more than 20 million cases have been reported, as of Aug 24, 2020. This study aimed to identify what the additional health-care costs of a strategic preparedness and response plan (SPRP) would be if current transmission levels are maintained in a status quo scenario, or under scenarios where transmission is increased or decreased by 50%.

Safety and immunogenicity of the live attenuated intranasal pertussis vaccine BPZE1: a phase 1b, double-blind, randomised, placebo-controlled dose-escalation study

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Lancet Infectious Diseases
Nov 2020 Volume 20 Number 11 p1217-1348, e275-e297
http://www.thelancet.com/journals/laninf/issue/current

 

Articles
Safety and immunogenicity of the live attenuated intranasal pertussis vaccine BPZE1: a phase 1b, double-blind, randomised, placebo-controlled dose-escalation study
Maja Jahnmatz, and the BPZE1 study team

Preparing for the vaccine

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Nature Biotechnology
Volume 38 Issue 11, November 2020
https://www.nature.com/nbt/volumes/38/issues/11

 

Editorial | 27 October 2020
Preparing for the vaccine
Clear and consistent messaging on COVID-19 vaccine rollout will be key to building public trust and managing expectations.
As approval of the first COVID-19 vaccine draws closer, attention is shifting to how to manufacture and distribute sufficient shots to supply national or global immunization programs. The challenge is unprecedented: to make enough vaccine not for a few million people, but for hundreds of millions of people. Ironically, the RNA and viral vector vaccines that are furthest along in clinical development are the least suitable for large-scale manufacture, storage and distribution. Until conventional vaccines become available that can capitalize on the existing immunization and distribution infrastructure, it seems likely that a large proportion of the world’s population will remain unvaccinated in 2021. In this context, clear and consistent public health communication to manage expectations about vaccine distribution, who gets the vaccine first, and full transparency as to the benefits as well as the risks will be key to building trust.

Thus far, public health messaging during the epidemic has been anything but clear and consistent.

Part of the problem is that new research has regularly upended expert advice, with inconsistent messaging on masks, testing and social distancing that has confused public understanding and compliance.

Vaccines represent an intervention where effective and consistent messaging will be critical to success because in recent decades scientific consensus on their value has been recast as controversy (or even conspiracy) in the public sphere. Social media have reinforced vaccine hesitancy, with religious leaders, family members or other trusted sources often perpetuating myths and misinformation.

According to a September report from Pew Research, only 51% of US adults say they definitely or probably would get vaccinated with a COVID-19 vaccine — a 21% percentage point drop from May. A survey of Europeans by the Vaccine Confidence Project found that 20% of Swiss and 18% of French respondents would refuse a vaccine; similarly, a recent YouGov survey found that one in six British adults would definitely or probably turn down a shot.

But ironically, it may be the unrealistic expectations of vaccine proponents that turns out to be as much as a problem: 55% of them would, apparently, be somewhat dissuaded if the vaccine was “only” 60% effective. And yet a vaccine that halves the risk of infection for an individual would be sufficient for a US Food and Drug Administration Emergency Use Authorization (EUA). For a public that expected 100% efficacy, 50% might feel like failure.

For SARS-CoV-2, many unanswered questions remain about natural immunity to the virus, let alone the nature and length of immune protection afforded by a vaccine. As long as doubts remain about the frequency of repeated infections, the capacity of reinfected individuals to spread or shed virus as well as develop symptomatic or even serious disease, and the length of protection afforded by neutralizing antibody titers, doubts will linger about COVID-19 vaccines. If immunized individuals still have to wear masks, vaccine uptake will be further disincentivized.

For those vaccines that receive an EUA, the coming challenge will be to meet demand. The United States, Britain, France and Germany have already grabbed hundreds of millions of doses via advance purchase agreements, but COVAX — a global initiative coordinated by Gavi, the Coalition for Epidemic Preparedness Initiative (CEPI) and the World Health Organization, which now includes China as well as another 170 nations — aims to obtain two billion doses of vaccines by the end of 2021 for low-to-middle income countries.

A CEPI survey estimates that global manufacturing capacity could produce two to four billion doses next year. As different facilities ramp up production, supply-chain bottlenecks for glass vials, pressure on fill and finish facilities and shortages of materials like bioreactors or adjuvants are likely to arise.

The public may also be surprised to find that all vaccines are not equal. It may not realize that RNA and viral vector vaccines — those most advanced in clinical development — are the least suitable for large-scale manufacture, storage and distribution and that they carry a greater technology risk. As no one has ever manufactured RNA vaccines with liposomal nanoparticles at this scale before — nor a viral vector vaccine — rollout might hit snags that tried and tested platforms (like inactivated or recombinant subunit vaccines) can avoid. The RNA vaccines also have onerous storage requirements (Pfizer/BioNtech’s product must be kept at–70 °C, Moderna’s at –20 °C). They are unlikely to be suitable for doctor’s offices or pharmacies in developed nations, let alone in developing countries. Why not get that message out there now to offset disappointment later?

Perhaps the trickiest dilemma, however, will be prioritizing who receives the vaccine first. A recent US National Academy of Medicine report suggests that personal vulnerabilities (comorbidities and age) and social vulnerabilities (high-risk work settings, use of public transportation, and crowding or multiple generations at home) should determine allotment. Vaccine distribution would proceed in distinct phases: first, healthcare workers, care workers, first responders and those with pre-existing conditions; then essential workers, school teachers and people in prison (because of close quarters); and then everyone else. This is likely to be controversial. During the 2009 H1N1 influenza pandemic, for example, an association of bread makers argued that its workers were essential. We should expect wrangling about who qualifies to be in what phase.

The global distribution of coronavirus vaccines will be the defining public health challenge of 2021. There will be snafus. There will be delays. But whatever happens, an early and coordinated health communication campaign on various media is needed to drive uptake in vulnerable groups and engage diverse stakeholders in ethnic communities. Vaccines should be positioned alongside hand-washing, social distancing, masking and isolation as part of the pandemic solution, not a panacea to immediately end it. Governments need to start informing the public now by being transparent and open about where vaccines actually are — and effectively communicating their plans for distributing them.

African ancient DNA research requires robust ethics and permission protocols

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Nature Reviews Genetics
Volume 21 Issue 11, November 2020
https://www.nature.com/nrg/volumes/21/issues/11

 

Comment | 16 September 2020
African ancient DNA research requires robust ethics and permission protocols
In Africa, there is a disparity in ethics and permission requirements for molecular research on samples from living people versus ancient DNA. At the precipice of the archaeogenomics revolution, heritage agencies require updated policies and procedures for genetic and genomic research on African ancient DNA.
Victoria E. Gibbon

A guide to cancer immunotherapy: from T cell basic science to clinical practice

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Nature Reviews Immunology
Volume 20 Issue 11, November 2020
https://www.nature.com/nri/volumes/20/issues/11

 

Review Article | 20 May 2020
A guide to cancer immunotherapy: from T cell basic science to clinical practice
T cells play a central role in immune responses to cancer. In this guide to cancer immunotherapy, the authors provide a comprehensive historical and biological perspective on cancer immunotherapy, with a focus on current and emerging therapeutic approaches that harness T cells to fight cancer.
Alex D. Waldman, Jill M. Fritz & Michael J. Lenardo

What makes a drug discovery consortium successful?

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Nature Reviews Drug Discovery
Volume 19 Issue 11, November 2020
https://www.nature.com/nrd/volumes/19/issues/11

 

Comment | 29 April 2020
What makes a drug discovery consortium successful?
Consortia are enabling drug discovery in areas that individual organizations are unable to support alone because of the high risk or the need to pool information. This article discusses desirable features that can underpin the success of such consortia.
Peter B. Simpson & Graeme F. Wilkinson

Modulating gene regulation to treat genetic disorders

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Nature Reviews Drug Discovery
Volume 19 Issue 11, November 2020
https://www.nature.com/nrd/volumes/19/issues/11

 

Review Article | 05 October 2020
Modulating gene regulation to treat genetic disorders
cis-Regulation therapy (CRT) — modifying the activity of gene-regulatory elements — is emerging as a potential approach to treat genetic diseases. Here, Matharu and Ahituv assess emerging CRT technologies and present proof-of-concept studies in cell and animal models. Key factors to be considered for the translation of CRT into the clinic are discussed.
Navneet Matharu & Nadav Ahituv

Emergency Use Authorization of Covid Vaccines — Safety and Efficacy Follow-up Considerations

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New England Journal of Medicine
November 5, 2020 Vol. 383 No. 19
http://www.nejm.org/toc/nejm/medical-journal

 

Perspective
Emergency Use Authorization of Covid Vaccines — Safety and Efficacy Follow-up Considerations P.R. Krause and M.F. Gruber
… Use of an investigational vaccine under an EUA would not be subject to the usual informed consent requirements for clinical investigations; nevertheless, vaccine recipients will be provided a fact sheet that describes the investigational nature of the product, the known and potential benefits and risks, available alternatives, and the option to refuse vaccination. To minimize the risk that use of a vaccine under an EUA will interfere with long-term assessment of safety and efficacy in ongoing trials, it will be essential to continue to gather data about the vaccine even after it is made available under the EUA. Continued follow-up of clinical trial participants to further refine efficacy estimates, further evaluate the potential for enhanced disease and waning of immunity, and obtain additional active safety follow-up will be essential in order to ensure public confidence in a broadly administered vaccine. The quality of the data available to inform ongoing assessment of a vaccine’s benefits and risks will depend on the ability to continue evaluating the vaccine against a placebo comparator in clinical trials for as long as feasible. Moreover, evaluation of other potentially superior vaccines will depend on the ability to continue to maintain placebo controls in ongoing trials. Thus, issuance of an EUA should not, in and of itself, require unblinding of a Covid-19 vaccine trial and immediate vaccination of placebo recipients, since doing so may jeopardize approval of these products.
In setting criteria for EUAs, regulators determine the amount of data that could support a positive benefit–risk assessment, providing people who wish to receive an investigational vaccine the opportunity to realize that benefit while also providing confidence that a vaccine is unlikely to cause net harm when used in this manner.
From a safety perspective, a 2-month median follow-up (meaning that at least half of vaccine recipients in clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen will allow identification of potential adverse events that were not apparent in the immediate postvaccination period and will also provide greater confidence in their absence, if none are observed…

Vaccine Effectiveness Against Pediatric Influenza Hospitalizations and Emergency Visits

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Pediatrics
Vol. 146, Issue 5 1 Nov 2020
https://pediatrics.aappublications.org/

 

Articles
Vaccine Effectiveness Against Pediatric Influenza Hospitalizations and Emergency Visits
Angela P. Campbell, Constance Ogokeh, Joana Y. Lively, Mary A. Staat, Rangaraj Selvarangan, Natasha B. Halasa, Janet A. Englund, Julie A. Boom, Geoffrey A. Weinberg, John V. Williams, Monica McNeal, Christopher J. Harrison, Laura S. Stewart, Eileen J. Klein, Leila C. Sahni, Peter G. Szilagyi, Marian G. Michaels, Robert W. Hickey, Mary E. Moffat, Barbara A. Pahud, Jennifer E. Schuster, Gina M. Weddle, Brian Rha, Alicia M. Fry, Manish Patel
Pediatrics, Nov 2020, 146 (5) e20201368

COVID-19 Trial Enrollment for Those Who Cannot Consent: Ethical Challenges Posed by a Pandemic

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Pediatrics
Vol. 146, Issue 5 1 Nov 2020
https://pediatrics.aappublications.org/

 

Ethics Rounds
COVID-19 Trial Enrollment for Those Who Cannot Consent: Ethical Challenges Posed by a Pandemic
Samantha A. House, Catherine D. Shubkin, Tim Lahey, Jeffrey P. Brosco, John Lantos
Pediatrics, Nov 2020, 146 (5) e2020010728
Abstract
The current coronavirus disease 2019 (COVID-19) pandemic has triggered an intense global research effort to inform the life-saving work of frontline clinicians who need reliable information as soon as possible. Yet research done in pressured circumstances can lead to ethical dilemmas, especially for vulnerable research subjects. We present the case of a child with neurocognitive impairment who is diagnosed with COVID-19 infection after presenting with fever and a seizure. The child lives in a group home and is in the custody of the state; her parents lost parental rights many years ago. Some members of the health care team want to enroll her in a randomized clinical trial evaluating an experimental treatment of COVID-19. For minor patients to enroll in this clinical trial, the institutional review board requires assent of patients and consent of guardians. An ethics consult is called to help identify relevant concerns in enrollment. In the accompanying case discussion, we address historical perspectives on research involving people with disabilities; proper management of research participation for people with disabilities including consent by proxy, therapeutic misconception, and other threats to the ethical validity of clinical trials; and the potentially conflicting obligations of researchers and clinicians.

Revisiting child and adolescent health in the context of the Sustainable Development Goals

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PLoS Medicine
http://www.plosmedicine.org/
(Accessed 7 Nov 2020)

 

Revisiting child and adolescent health in the context of the Sustainable Development Goals
Zulfiqar A. Bhutta, Kathryn M. Yount, Quique Bassat, Artur A. Arikainen
Editorial | published 30 Oct 2020 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1003449
[Excerpt]
…As we examine the situation more than 5 years into the SDGs, several concerns emerge. Despite progress, the field remains fragmented, with limited actions in countries to develop integrated strategies for reproductive, maternal, newborn and child health (RMNCH), or inclusion of adolescent health within national plans [5]. Work on the drivers of adolescent health, well being, and empowerment is underway but has yet to translate into a reasonable global strategy. This lag stems from complex, multilevel social influences during adolescence [6], insufficient disaggregation of data on adolescents, suboptimal measurement and a lack of well-defined indicators [7–9], and limited evidence on the differential impacts of social policies and programs [8] within adolescence and between adolescence and adulthood. Within health systems, many nutrition programs remain poorly integrated with other RMNCH programs and few have substantive links with sectors outside health. With the unfinished agenda for maternal, newborn and child deaths, rigorous studies to address mechanisms and hitherto unrecognized causes of excess mortality are just beginning to yield results, albeit with older pediatric age groups remaining significantly understudied, even at the simplest descriptive level [5]. Effort is limited to bring mental-health programming to women and children, especially in conflict settings or emergencies such as the COVID-19 pandemic. These silos in research, planning and policy, and service delivery apply equally to other sectors, and to multi-sectoral planning and implementation at country level. To address the SDGs, we must consider life in the 21st century—including the disruptions of technological change, economic shocks, climate change, and conflict and security…

Informing children citizens efficiently to better engage them in the fight against COVID-19 pandemic

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PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 7 Nov 2020)

 

Viewpoints
Informing children citizens efficiently to better engage them in the fight against COVID-19 pandemic
Jean-Eric Ghia, Sophie Gaulin, Laure Ghia, Laure Garancher, Claude Flamand
| published 04 Nov 2020 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0008828
Abstract
Since the beginning of the year, the world’s attention has rightly been focused on the spread of the Coronavirus Disease 2019 (COVID-19) pandemic and the implementation of drastic mitigation strategies to limit disease transmission. However, public health information campaigns tailored to children are very rare. Now more than ever, at a time when some governments are taking populations out of lockdown and youth are returning to schools, children around the world need to fully grasp the modes of transmission of the disease, the health risks, the scientific notions of the immune system, the value of barrier measures, and the progress of scientific research. In the context of the COVID-19 pandemic, comics can be very useful for communicating quickly and effectively abstract and important information to children who might be under the influence of a large amount of sometimes contradictory information. Conveying precise, reliable, and accessible information to children is key in a world overwhelmingly impacted by the outbreak. This should be the role and the responsibility of world health official leaders and governments in compliance with the United Nations Convention on the Rights of the Child. In partnership with mainstream medias, consortia of scientists, communication experts, and education specialists, it is urgent that world leaders engage children in this worldwide public health fight.
… The use of appropriate governmental communication using comic books, cartoons, appropriate websites, and social media would then make it possible to raise awareness among children about the modes of transmission of the disease, the health risks, the scientific notions of the immune system, the value of barrier measures, and the progress of scientific research. More than texts, comics could be better suited for information campaigns on social media like TikTok [23] and other popular apps. Ideally, they would be tailored by governments, scientific consortium, and educational experts to reach younger citizens….

Scientific quality of COVID-19 and SARS CoV-2 publications in the highest impact medical journals during the early phase of the pandemic: A case control study

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

 

Research Article
Scientific quality of COVID-19 and SARS CoV-2 publications in the highest impact medical journals during the early phase of the pandemic: A case control study
Marko Zdravkovic, Joana Berger-Estilita, Bogdan Zdravkovic, David Berger
Research Article | published 05 Nov 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0241826

Programmatic assessment of electronic Vaccine Intelligence Network (eVIN)

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

 

Programmatic assessment of electronic Vaccine Intelligence Network (eVIN)
Vandana Gurnani, Prem Singh, Pradeep Haldar, Mahesh Kumar Aggarwal, Kiran Agrahari, Satabdi Kashyap, Shreeparna Ghosh, Mrinal Kar Mohapatra, Ruma Bhargava, Partha Nandi, Pritu Dhalaria
Research Article | published 05 Nov 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0241369
Abstract
eVIN is a technology system that digitizes vaccine stocks through a smartphone application and builds the capacity of program managers and cold chain handlers to integrate technology in their regular work. To effectively manage the vaccine logistics, in 2015, this technology was rolled-out in 12 states of India. This study assessed the programmatic usefulness of eVIN implementation in the areas of vaccine utilization, vaccine stock and distribution management and documentation across selected cold chain points. A pre-post study design was used, where cold chain points (CCPs) were selected using two-stage sampling technique in eVIN states. Pre-post comparative analysis was carried out on the identified indicators using both primary and secondary data sources. The vaccine utilization data reflects that the utilization had reduced from 305.3 million doses in pre-eVIN period to 215.0 million doses in post-eVIN period across 12 eVIN states, resulting into savings of approximately 90 million doses of vaccines. Number of facilities having stock-out of any vaccine showed a significant reduction by 30.4% in post-eVIN period (p<0.001). There was a 4.0% drop in facilities reporting minimum stock of any vaccine after implementation of eVIN. Facilities with maximum stock of any vaccine had increased from 37.4% in pre-eVIN to 39.2% in post-eVIN. During the pre-eVIN period, only 38.6% facilities updated vaccine stock on a daily basis, while in post-eVIN period, 53.5% facilities updated vaccine stock on daily basis. The completeness of records in the vaccine stock registers, indent form and temperature logbook have been substantially improved in the post-eVIN period (p<0.001). eVIN had helped in streamlining the vaccine flow network and ensured equity through better vaccine management practices. It is a powerful contribution to strengthen the vaccine supply chain and management. Upscaling eVIN in the remaining states of India will be crucial in improving the efficacy of vaccines and cold chain management.

Public attitudes toward allocating scarce resources in the COVID-19 pandemic

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

Public attitudes toward allocating scarce resources in the COVID-19 pandemic
Wesley Buckwalter, Andrew Peterson

Research Article | published 04 Nov 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0240651
Abstract
The general public is subject to triage policies that allocate scarce lifesaving resources during the COVID-19 pandemic, one of the worst public health emergencies in the past 100 years. However, public attitudes toward ethical principles underlying triage policies used during this pandemic are not well understood. Three experiments (preregistered; online samples; N = 1,868; U.S. residents) assessed attitudes toward ethical principles underlying triage policies. The experiments evaluated assessments of utilitarian, egalitarian, prioritizing the worst-off, and social usefulness principles in conditions arising during the COVID-19 pandemic, involving resource scarcity, resource reallocation, and bias in resource allocation toward at-risk groups, such as the elderly or people of color. We found that participants agreed with allocation motivated by utilitarian principles and prioritizing the worst-off during initial distribution of resources and disagreed with allocation motivated by egalitarian and social usefulness principles. At reallocation, participants agreed with giving priority to those patients who received the resources first. Lastly, support for utilitarian allocation varied when saving the greatest number of lives resulted in disadvantage for at-risk or historically marginalized groups. Specifically, participants expressed higher levels of agreement with policies that shifted away from maximizing benefits to one that assigned the same priority to members of different groups if this mitigated disadvantage for people of color. Understanding these attitudes can contribute to developing triage policies, increase trust in health systems, and assist physicians in achieving their goals of patient care during the COVID-19 pandemic.

Carrying Out Rapid Qualitative Research During a Pandemic: Emerging Lessons From COVID-19

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Qualitative Health Research
Volume 30 Issue 14, December 2020
http://qhr.sagepub.com/content/current

 

Research Articles
Carrying Out Rapid Qualitative Research During a Pandemic: Emerging Lessons From COVID-19
Cecilia Vindrola-Padros, Georgia Chisnall, Silvie Cooper, Anna Dowrick, Nehla Djellouli, Sophie Mulcahy Symmons, Sam Martin, Georgina Singleton, Samantha Vanderslott, Norha Vera, Ginger A. Johnson
First Published August 31, 2020; pp. 2192–2204

Prospects for a safe COVID-19 vaccine

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Science Translational Medicine
04 November 2020 Vol 12, Issue 568
https://stm.sciencemag.org/

 

Review
Prospects for a safe COVID-19 vaccine
By Barton F. Haynes, Lawrence Corey, Prabhavathi Fernandes, Peter B. Gilbert, Peter J. Hotez, Srinivas Rao, Michael R. Santos, Hanneke Schuitemaker, Michael Watson, Ann Arvin
Science Translational Medicine04 Nov 2020 Full Access
Prior vaccine development experiences do not raise concerns about vaccine-associated enhanced disease for COVID-19 vaccine candidates.

Investigating spatial variation and change (2006–2017) in childhood immunisation coverage in New Zealand

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Social Science & Medicine
Volume 263 October 2020
https://www.sciencedirect.com/journal/social-science-and-medicine/vol/262/suppl/C

 

Research article Abstract only
Investigating spatial variation and change (2006–2017) in childhood immunisation coverage in New Zealand
Lukas Marek, Matthew Hobbs, John McCarthy, Jesse Wiki, … Simon Kingham
Article 113292

Elevating the uses of storytelling approaches within Indigenous health research: a critical and participatory scoping review protocol involving Indigenous people and settlers

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Systematic Reviews
https://systematicreviewsjournal.biomedcentral.com/articles
[Accessed 7 Nov 2020]

 

https://stm.sciencemag.org/
Elevating the uses of storytelling approaches within Indigenous health research: a critical and participatory scoping review protocol involving Indigenous people and settlers
There is a complicated and exploitative history of research with Indigenous peoples and accompanying calls to meaningfully and respectfully include Indigenous knowledge in healthcare. Storytelling approaches t…
Authors: Kendra L. Rieger, Sarah Gazan, Marlyn Bennett, Mandy Buss, Anna M. Chudyk, Lillian Cook, Sherry Copenace, Cindy Garson, Thomas F. Hack, Bobbie Hornan, Tara Horrill, Mabel Horton, Sandra Howard, Janice Linton, Donna Martin, Kim McPherson…
Citation: Systematic Reviews 2020 9:257
Content type: Protocol
Published on: 4 November 2020

A QuESt for speed: rapid qualitative evidence syntheses as a response to the COVID-19 pandemic

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Systematic Reviews
https://systematicreviewsjournal.biomedcentral.com/articles
[Accessed 7 Nov 2020]

 

A QuESt for speed: rapid qualitative evidence syntheses as a response to the COVID-19 pandemic
The COVID-19 pandemic has created a sense of urgency in the research community in their bid to contribute to the evidence required for healthcare policy decisions. With such urgency, researchers experience met…
Authors: Linda Biesty, Pauline Meskell, Claire Glenton, Hannah Delaney, Mike Smalle, Andrew Booth, Xin Hui S. Chan, Declan Devane and Catherine Houghton
Citation: Systematic Reviews 2020 9:256
Content type: Methodology
Published on: 4 November 2020

Exploring uncertainty and risk in the accelerated response to a COVID-19 vaccine: Perspective from the pharmaceutical industry

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Vaccine
Volume 38, Issue 48 Pages 7569-7696 (10 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/47

 

Research article Open access
Exploring uncertainty and risk in the accelerated response to a COVID-19 vaccine: Perspective from the pharmaceutical industry
L. Coudeville, G.B. Gomez, O. Jollivet, R.C. Harris, … C. Mahé
Pages 7588-7595

Rural, urban, and suburban differences in influenza vaccination coverage among children

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Vaccine
Volume 38, Issue 48 Pages 7569-7696 (10 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/47

 

Research article Abstract only
Rural, urban, and suburban differences in influenza vaccination coverage among children
Yusheng Zhai, Tammy A. Santibanez, Katherine E. Kahn, Anup Srivastav, … James A. Singleton
Pages 7596-7602

Assessment of missed opportunities for vaccination (MOV) in Burkina Faso using the World Health Organization’s revised MOV strategy: Findings and strategic considerations to improve routine childhood immunization coverage

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Vaccine
Volume 38, Issue 48 Pages 7569-7696 (10 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/47

 

Research article Open access
Assessment of missed opportunities for vaccination (MOV) in Burkina Faso using the World Health Organization’s revised MOV strategy: Findings and strategic considerations to improve routine childhood immunization coverage
Lassané Kaboré, Bertrand Meda, Isaie Médah, Stephanie Shendale, … Ikechukwu U. Ogbuanu
Pages 7603-7611

Knowledge, attitudes and practices about vaccine-preventable diseases and vaccinations of children among pregnant women in Greece

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Vaccine
Volume 38, Issue 48 Pages 7569-7696 (10 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/47

 

Research article Abstract only
Knowledge, attitudes and practices about vaccine-preventable diseases and vaccinations of children among pregnant women in Greece
Helena C. Maltezou, Marianna Theodora, Theodore Lytras, Aikaterini Fotiou, … Alexandros Rodolakis
Pages 7654-7658

Immunization costs, from evidence to policy: Findings from a nationally representative costing study and policy translation effort in Tanzania

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Vaccine
Volume 38, Issue 48 Pages 7569-7696 (10 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/47

 

Research article Open access
Immunization costs, from evidence to policy: Findings from a nationally representative costing study and policy translation effort in Tanzania
Kelsey Vaughan, Emma Clarke-Deelder, Kassimu Tani, Dafrossa Lyimo, … Annette Ozaltin
Pages 7659-7667

Influenza Vaccination Hesitancy among Healthcare Workers in South Al Batinah Governorate in Oman: A Cross-Sectional Study

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Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 7 Nov 2020)

 

Open Access Article
Influenza Vaccination Hesitancy among Healthcare Workers in South Al Batinah Governorate in Oman: A Cross-Sectional Study
by Salah T. Al Awaidy, Zayid K. Al Mayahi, Malak Kaddoura, Ozayr Mahomed, Nathalie Lahoud, Abdinasir Abubakar and Hassan Zaraket
Vaccines 2020, 8(4), 661; https://doi.org/10.3390/vaccines8040661 – 06 Nov 2020
Abstract
Background: Seasonal influenza infections are a major cause of morbidity and mortality worldwide. Healthcare workers (HCWs) are an important target group for vaccination against influenza due to their increased risk of infection and their potential to transmit the infection to their patients, families […]

Vaccine Hesitancy in China: A Qualitative Study of Stakeholders’ Perspectives

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Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 7 Nov 2020)

 

Open Access Communication
Vaccine Hesitancy in China: A Qualitative Study of Stakeholders’ Perspectives
by Ronghui Yang, Bart Penders and Klasien Horstman
Vaccines 2020, 8(4), 650; https://doi.org/10.3390/vaccines8040650 – 03 Nov 2020
Viewed by 213
Abstract
A series of vaccine incidents have stimulated vaccine hesitance in China over the last decade. Many scholars have studied the institutional management of these incidents, but a qualitative study of stakeholders’ perspectives on vaccine hesitancy in China is missing. To address this lacuna, […]

Media/Policy Watch

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

 

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 7 Nov 2020
[No new, unique, relevant content]

 

BBC
http://www.bbc.co.uk/
Accessed 7 Nov 2020
[No new, unique, relevant content]

 

The Economist
http://www.economist.com/
Accessed 7 Nov 2020
[No new, unique, relevant content]

 

Financial Times
https://www.ft.com/
Accessed 7 Nov 2020
US presidential election 2020
Biden plans to name Covid task force on Monday
November 7, 2020
Top of Form
Bottom of Form

Coronavirus treatment
Covid-19 vaccine market worth $10bn a year, analysts say
…The future Covid-19 vaccine market could be worth more than $10bn a year, generating bumper revenues for pharmaceutical companies that have funded large parts of their research with government money…
November 5, 2020

 

Forbes
http://www.forbes.com/
Accessed 7 Nov 2020
Nov 6, 2020
A More Transparent And Trusted Covid Vaccine
A new article highlights the need to increase transparency around Covid-19 vaccines.
By William A. Haseltine Contributor

Nov 6, 2020
More Than 200 People Catch Mink-Related Covid-19 In Denmark Since June, Prompting World Health Organization To Investigate
Denmark ordered the culling of 17 million mink, its entire herd, after a dangerous new Covid-19 strain spread to humans.
By Robert Hart Forbes Staff

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 7 Nov 2020
Snapshot November 5, 2020
China Is Winning the Vaccine Race
How Beijing positioned itself as the savior of the developing world.
Eyck Freymann and Justin Stebbing

 

Foreign Policy
http://foreignpolicy.com/
Accessed 7 Nov 2020
[No new, unique, relevant content]

 

The Guardian
http://www.guardiannews.com/
Accessed 7 Nov 2020
[No new, unique, relevant content]

 

New Yorker
http://www.newyorker.com/
Accessed 7 Nov 2020
[No new, unique, relevant content]

 

New York Times
http://www.nytimes.com/
Accessed 7 Nov 2020
World
In Hunt for Virus Source, W.H.O. Let China Take Charge
As it praised Beijing, the World Health Organization concealed concessions to China and may have sacrificed the best chance to unravel the virus’s origins.
Nov. 2

 

Washington Post
https://www.washingtonpost.com/
Accessed 7 Nov 2020
[No new, unique, relevant content]

Think Tanks et al

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Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 7 Nov 2020
[No new relevant content]
 
 
Center for Global Development [to 7 Nov 2020]
http://www.cgdev.org/page/press-center
Report
November 2, 2020
Bridging the Gap Between Need and Innovation: The Case of Vaccines
To attain and sustain universal health coverage, we must harness the power of healthcare innovation. But how can we do so when in many settings, these innovations do not align with local priorities?
Rachel Archer, Yot Teerawattananon and Francis Ruiz
 
 
Chatham House [to 7 Nov 2020]
https://www.chathamhouse.org/
Event
Members Event The Virus, the Vaccine and Violence
23 November 2020 — 4:00PM TO 5:15PM
This webinar assesses the potential for conflict-sensitive approaches to COVID-19 with a focus on vaccines.

 
 

CSIS
https://www.csis.org/
Accessed 7 Nov 2020
Podcast Episode
Coronavirus Crisis Update: Helene Gayle – How to Allocate a Covid-19 Vaccine Equitably?
November 3, 2020 | By J. Stephen Morrison, H. Andrew Schwartz

 
 
Council on Foreign Relations
http://www.cfr.org/
Accessed 7 Nov 2020
[No new relevant content]

 
 
Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 7 Nov 2020
November 2, 2020 News Release
Wide Variations in Flu Vaccination Rates Across States Highlight Challenges as State and Local Authorities Plan to Distribute a COVID-19 Vaccine
When a COVID-19 vaccine becomes available, all or most people living in the country will need to get vaccinated in order to maximize its benefits and provide adequate immunity nationwide. That could present a daunting challenge for state and local health officials, as a new KFF analysis shows vaccination rates…

Vaccines and Global Health: The Week in Review :: 31 October 2020

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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: 

vaccines-and-global-health_the-week-in-review_31-oct-2020-1Download

– 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

Funding for COVID-19 Vaccines, Treatments Fastest Way to Save Lives, Economy, Secretary-General Tells World Health Summit, Urging Global Solidarity

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Milestones :: Perspectives :: Research

 

Funding for COVID-19 Vaccines, Treatments Fastest Way to Save Lives, Economy, Secretary-General Tells World Health Summit, Urging Global Solidarity
25 October 2020 SG/SM/20364
Following is UN SecretaryGeneral António Guterres’ message to the virtual World Health Summit, in New York today:
The COVID-19 pandemic is the greatest crisis of our age.  Just seven months since it was declared, over 1 million people have died, and tens of millions have been infected.  Cases are still rising, and new spikes and waves are occurring in places that had suppressed the virus for many months.

 

The indirect impact of the pandemic is wreaking havoc on societies and economies.  Travel restrictions and lockdowns have resulted in the loss of 500 million jobs so far and are costing the global economy some $375 billion every month.

Reports of gender-based violence are skyrocketing.  Mental illness is a crisis within a crisis.  Deaths from other health conditions are likely to increase, as resources are redirected towards COVID-19.  Some 24 million children could drop out of school, with lifelong impact.  COVID-19 is driving us even farther off course from achieving the vision and promise of the 2030 Agenda for Sustainable Development.

The first hard lesson of this crisis is that we were not prepared.  Global health and emergency response systems have been tested and found wanting.  Access to health is a human right denied to billions of people around the world.

Universal health coverage is the path to high-quality, equitable, affordable health care.  Strong public health systems and emergency preparedness are essential steps to greater resilience.  All countries have signed up to universal health coverage by 2030.  But, we cannot wait 10 years.  We need health systems that work, before we face an outbreak of something more contagious than COVID-19, more deadly or both.

The second lesson is that we are not powerless.  If we follow the science, and demonstrate unity and solidarity, we can overcome the pandemic.  Public health measures, including masks, physical distancing and handwashing, are proven means of keeping the virus at bay.

We need to protect the vulnerable – older people and those with pre-existing conditions.  We must stop holding and attending events that amplify the spread of the virus; and we must work with communities on sharing information and building trust.

Numerous Governments have demonstrated that taking targeted, local measures immediately outbreaks occur can stamp them out.  At the same time, we must persevere with comprehensive public health measures that the World Health Organization (WHO) identified on day one:  find, isolate, test and care for cases, and trace and quarantine their contacts.

Third, we need global solidarity every step of the way.  Developed countries must support health systems in countries that are short of resources.  And we must join together as Governments, the private sector, civil society and all partners, to make sure vaccines, tests and treatments are available to everyone, everywhere.  A vaccine must be a global public good.

Fully funding the ACT-Accelerator is the fastest way to end the pandemic.  Vaccines, tests and therapies are more than life savers.  They are economy savers and society savers.

There is no choice between saving people’s lives and saving jobs.  Protecting people from the virus is the best way to keep schools open and businesses running.  It will prevent the virus from spreading even more widely and returning in wave after wave.

But, as I have said before, there is no panacea during a pandemic.  Relief will come not through one single step, but through smartly combining cutting-edge research with basic public health.

The fourth lesson is that misinformation and disinformation are deadly allies of the virus.  They are contributing to deaths and infections, and to social tensions that have led to violence.  Unless we counter rumours, conspiracy theories and lies, they will negate our other efforts.

The United Nations “Verified” campaign aims to ensure people have access to accurate advice that protects and promotes health.  I welcome efforts by social media platforms and others to prevent the spread of false stories and advice, and promote scientific, fact-based analysis — although more needs to be done.

The World Health Summit and the M8 Alliance are important platforms to champion and work together for global health.  This gathering, bringing together science, politics, business and civil society, is the place to build new partnerships, share best practices and take decisions that could save lives.  Let us use this opportunity to confront the COVID-19 crisis together, with the urgency and integrity it requires.  Thank you.

IFFIm Prices US$500 Million 3-year Benchmark Vaccine Bonds

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Milestones :: Perspectives :: Research

 

IFFIm Prices US$500 Million 3-year Benchmark Vaccine Bonds
London, 29 October 2020 – The International Finance Facility for Immunisation Company (IFFIm) today priced US$500 million, 3-year fixed rate benchmark Vaccine Bonds that will provide Gavi, the Vaccine Alliance, flexible funding for its core immunisation programmes and efforts to develop and distribute eventual COVID-19 vaccines to countries around the world, particularly the poorest.

The transaction will mature on 6 November 2023, has a re-offer price of 99.821%, and carries a semi-annual coupon of 0.375%. This is IFFIm’s first US$ benchmark bond since its US$300 million 3-year floating rate bond in November 2017. Citi, Crédit Agricole CIB, and TD Securities are lead managers of the transaction.

“As the world confronts a devastating pandemic, this latest Vaccine Bond issuance is giving Gavi the financing it needs to act quickly, boldly and flexibly,” said IFFIm Board Chair Cyrus Ardalan. “These bonds enable private sector investors to directly contribute to a critical effort to address one of the biggest global challenges we face.”

“IFFIm’s Vaccine Bonds have long been an indispensable tool that allows Gavi to do what is necessary to ensure the availability of vaccines to the world’s poorest children,” said Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance. “This latest issuance will give Gavi the financial headroom to continue that core work, which has been complicated by the COVID-19 pandemic, as well as to play an essential role in the global collaboration to develop and equitably distribute eventual COVID-19 vaccines around the world.”

“We are pleased to see a robust response from investors for IFFIm and Gavi to support vaccine development and distribution in response to COVID-19,” said Jingdong Hua, Vice President and Treasurer of the World Bank, IFFIm’s Treasury Manager. “Investors are making a critical contribution to vaccine availability in the poorest countries, while benefitting from a uniquely impactful investment opportunity and the strong credit quality of the issuer.”

The diversified and high-quality orderbook reflects the appeal of the IFFIm mission with global investors. Geographic placement was 52% for Europe, Middle East and Africa and 40% for the Americas with the remaining 8% placed with Asian investors. Central banks and official institutions took 60%, asset managers, pension funds and insurance funds made up 26% and banks, bank treasuries and corporates rounded out the book with 14%…

COVAX welcomes appointment of civil society representatives

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Milestones :: Perspectives :: Research

 

COVAX welcomes appointment of civil society representatives
Geneva, 30 October 2020 – As part of the global response to the COVID-19 pandemic, COVAX – the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, co-led by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organization (WHO) – welcomes the appointment of civil society organisation (CSO) representatives to key COVAX working groups. The involvement of civil society has been crucial in public health campaigns in recent years – in promoting access to health products, engaging with the public, and expanding the reach of public health organisations in rolling out programmes around the world.

The representatives were selected by a civil society selection committee made up of members from 10 civil society organisations from 7 countries and 4 continents. The ten nominees were selected from a pool of 159 candidates based on a range of criteria: technical expertise, CSO experience and connectedness, knowledge of immunization and engagement of CSOs in the immunization space, and the detailed technical criteria outlined in the call for applications for each workstream. Gender and geographical diversity were also taken into consideration. In addition, all candidates were thoroughly assessed by the COVAX workstream leads and leadership.

The selected representatives will be involved in a number of key groups working contributing to the only global solution for equitable access to COVID-19 vaccines for the most vulnerable groups around the world. The ten civil society and community representatives will provide valuable technical expertise and use their experiences to play an important role in the success of COVAX.

COVID-19 Vaccines: World Bank Country Financing/Oversight

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Milestones :: Perspectives :: Research

 

COVID-19 Vaccines: World Bank Country Financing/Oversight

 

Editor’s Note:
In our edition of 17 October 2020, we reported on a World Bank Group [WBG] announcement of a USD$12 billion “envelope for developing countries to finance the purchase and distribution of COVID-19 vaccines, tests, and treatments for their citizens.”

In a supporting document – WBG VACCINE ANNOUNCEMENT– KEY FACTS – the World Band noted that it “will help client countries develop appropriate criteria for making the selected vaccine available to all their citizens.” This document references a “consensus to first target health workers, other essential workers, and priority groups such as the elderly, people with co-morbidities, and others at high risk from COVID-19” and added that “the Bank will ensure that the allocation mechanisms within countries are fair and equitable.”

Given the number of active COVID-19 vaccine allocation frameworks and guidance documents, the role of multilateral collaborations such as COVAX, and varying regulatory and recommending bodies, we found this stated role ensuring that allocation is fair and equitable to be quite interesting.

 

The Center for Vaccine Ethics and Policy [CVEP] raised five questions about this oversight role with the World Bank. The questions and the WBG answers are presented below:

[1] [CVEP] Will WBG be using any specific “active” normative guidance [WHO Values Framework; COVAX allocation framework, NSAEM Framework, country-level allocation strategies, etc.] to define/guide what ” fair and equitable” will mean in a country’s allocation mechanisms? If not, will WBG create its own guidance?
[WBG] Country allocation strategies will be appraised for their alignment with the WHO Fair Allocation Framework before Bank financing for vaccine purchase will be committed.
 
[2] [CVEP] Would the vaccine allocation “formula/strategy” be specified in the financing terms of the World Bank “grants, credits, and loans” that might be employed in any given country situation?
[WBG] There is no predetermined allocation of financing to countries.   Countries will decide the amounts within their IBRD/IDA allocations, and will access the financing on their applicable country specific IDA or IBRD financing terms.
[International Bank for Reconstruction and Development/International Development Association]

[3] [CVEP] What WBG governance/review mechanism will be employed to assess/confirm that the allocation approach proposed by the country is, indeed, fair and equitable? What monitoring mechanism will ensure that the allocation plan is executed adequately in that regard?
[WBG] The Bank will appraise the client’s overall vaccination strategy, including its specific allocation approach, before committing financing for vaccine purchases. The appraisal of the allocation framework will consider alignment with the WHO Fair Allocation Framework as well compliance with Bank risk management frameworks and policies as applicable, such as the Environmental and Social Framework. Bank teams will supervise implementation of the project and provide implementation support to the client as in any Bank-financed operation, including to monitor compliance with the agreed allocation plan.

[4] [CVEP] Does WBG intend to take a position on COVID-19 vaccine program elements beyond “fairness and equitable access”? Such elements would include requirements for a consent process [at least where a vaccine is still investigational [EUA without Phase III data/not yet licensed by any major reg authority]], ad mandates [where a government may require immunization with a vaccine which still may be EUA, for example]?
[WBG] Given the unprecedented pace of vaccine development, the Bank will accept as the threshold for eligibility of IBRD/IDA resources for vaccine purchase either (i) approval by Stringent Regulatory Authorities (SRAs) in three regions or (ii) WHO prequalification and approval by 1 SRA*.

[5] [CVEP] Does the WBG program anticipate that multiple COVID-19 vaccines — with varying profiles [EUA vs major reg approval; safety; efficacy; durability of protection; etc.] — will be in play in the same country at the same time, with varying constellations over time? This complexity suggests a very dynamic allocation scenario that will change, perhaps continuously, over 2+ years at least…
[WBG] We are working in complexity and a high degree of uncertainty and have developed the programmatic framework with the best available information.  As the vaccine landscape continues to develop we take a dynamic view in supporting countries to ensure their programs are  adapted to help maximize impact for their populations.

*List of Stringent Regulatory Authorities (SRAs) [WHO]
…The interim definition of an SRA includes the same elements as the current definition, each qualified by the wording “as before 23 October 2015”, as follows:
“A regulatory authority which is:
[a] a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before 23 October 2015); or
[b] an ICH observer, being the European Free Trade Association, as represented by Swissmedic, and Health Canada (as before 23 October 2015); or
[c] a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement, including Australia, Iceland, Liechtenstein and Norway (as before 23 October 2015).”
Currently there are 35 country NRAs [National Regulatory Authorities]which are designated as SRAs: Australia Austria Belgium Bulgaria Canada Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Japan Latvia Liechtenstein
Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Slovakia
Slovenia Spain Sweden Switzerland United Kingdom United States of America

COVID 19 Vaccine Development/Regulatory/Distribution Programs Update

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Milestones :: Perspectives :: Research

 

COVID 19 Vaccine Development/Regulatory/Distribution Programs Update

Dr. Reddy’s partners with Department of Biotechnology – Biotechnology Industry Research Assistance Council for Sputnik V vaccine clinical trials in India
HYDERABAD, India–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), announced its partnership with Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT), Government of India, for advisory support on clinical trials of Sputnik V vaccine in India.
“We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. We look forward to working with them to accelerate our efforts in bringing the vaccine to India.”
The partnership will allow Dr. Reddy’s to identify and use some of BIRAC’s clinical trial centres for the vaccine, which are funded under the National Biopharma Mission (NBM), implemented by Project Management Unit-NBM at BIRAC. Further, the Company will have access to Good Clinical Laboratory Practice (GCLP) labs to conduct immunogenicity assay testing of the vaccine.
Satish Reddy, Chairman, Dr. Reddy’s Laboratories said, “We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. We look forward to working with them to accelerate our efforts in bringing the vaccine to India.”…

::::::

Moderna Partners with Takeda and the Government of Japan to Supply 50 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) to Japan
MHLW and Takeda will import and distribute mRNA-1273 in Japan starting in the first half of 2021
October 28, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., Ltd (NYSE: TAK) have agreed to purchase and distribute 50 million doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support Japan’s aim of providing vaccines to the Japanese public as soon as possible, subject to necessary regulatory approvals. Moderna is responsible for the manufacture and supply of Moderna’s vaccine candidate, and Takeda, with the support of the MHLW, the Japan Agency for Medical Research and Development (AMED) and Moderna, is responsible for all import, local regulatory, development and distribution activities in Japan to ensure timely access starting during the first half of 2021…

::::::

UK Medicines and Healthcare products Regulatory Agency Begins Rolling Review of Moderna’s mRNA Vaccine Against COVID-19 (mRNA-1273)
Moderna completed enrollment of its Phase 3 COVE study of mRNA-1273 on October 22
Rolling review based on preclinical, CMC, and clinical data available to date
October 27, 2020

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has started the rolling review process of mRNA-1273, the Company’s vaccine candidate against COVID-19. This announcement follows positive results from a preclinical viral challenge study of mRNA-1273 and the positive interim analysis of the Phase 1 study of mRNA-1273 in adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine…

::::::

Moderna Announces Supply Agreement with the Ministry of Public Health to Supply Qatar with mRNA Vaccine Against COVID-19 (mRNA-1273)
Supply agreement reflects Moderna’s commitment to make its vaccine available in Qatar
October 26, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a supply agreement with the Ministry of Public Health of Qatar for mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support the Ministry’s ongoing efforts to secure early access to a safe and effective COVID-19 vaccine for the people of Qatar…