Curing COVID-19

Lancet Infectious Diseases
Oct 2020, Volume 20 Number 10 p1101-1216, e250-e283
http://www.thelancet.com/journals/laninf/issue/current

 

Editorial
Curing COVID-19
The Lancet Infectious Diseases
As the COVID-19 pandemic moves into its 10th month, greater patient survival suggests that treatment of severe disease has improved. How much of this improvement is due to better supportive care and how much to pharmaceuticals is a matter of debate. Given the huge effort that the biomedical community has put into finding drugs to treat COVID-19, with thousands of trials completed and ongoing, it’s worth taking stock of the evidence for what has worked and what has not…

Vaccinology: time to change the paradigm?

Lancet Infectious Diseases
Oct 2020, Volume 20 Number 10 p1101-1216, e250-e283
http://www.thelancet.com/journals/laninf/issue/current

 

Personal View
Vaccinology: time to change the paradigm?
Christine Stabell Benn, Ane B Fisker, Andreas Rieckmann, Signe Sørup, Peter Aaby
Summary
The existing vaccine paradigm assumes that vaccines only protect against the target infection, that effective vaccines reduce mortality corresponding to the target infection’s share of total mortality, and that the effects of vaccines are similar for males and females. However, epidemiological vaccine research has generated observations that contradict these assumptions and suggest that vaccines have important non-specific effects on overall health in populations. These include the observations that several live vaccines reduce the incidence of all-cause mortality in vaccinated compared with unvaccinated populations far more than can be explained by protection against the target infections, and that several non-live vaccines are associated with increased all-cause mortality in females. In this Personal View we describe current observations and contradictions and define six emerging principles that might explain them. First, that live vaccines enhance resistance towards unrelated infections. Second, non-live vaccines enhance the susceptibility of girls to unrelated infections. Third, the most recently administered vaccination has the strongest non-specific effects. Fourth, combinations of live and non-live vaccines given together have variable non-specific health effects. Fifth, vaccinating children with live vaccines in the presence of maternal immunity enhances beneficial non-specific effects and reduces mortality. Finally, vaccines might interact with other co-administered health interventions, for example vitamin A supplementation. The potential implications for child health are substantial. For example, if BCG vaccination was given to children at birth, if higher measles vaccination coverage could be obtained, if diphtheria, tetanus, and pertussis-containing vaccines were not given with or after measles vaccine, or if the BCG strain with the best non-specific effects could be used consistently, then child mortality could be considerably lower. Pursuing these emerging principles could improve our understanding and use of vaccines globally.

Patient-partnered clinical research

Nature Medicine
Volume 26 Issue 10, October 2020
https://www.nature.com/nm/volumes/26/issues/10

 

Patient-partnered clinical research
The path to productive collaboration between researchers and patients is not always easy, with language differences, knowledge gaps and power dynamics setting considerable barriers along the way. In this issue, we explore how patient- and community-led research is achievable if both sides make it a priority. The cover, designed by illustrator Sarah Lippett, a person living with a rare disease who explores her diagnostic odyssey in her work, shows how effective and equitable patient–researcher collaboration can be transformative to research.

Scientists, keep an open line of communication with the public

Nature Medicine
Volume 26 Issue 10, October 2020
https://www.nature.com/nm/volumes/26/issues/10

 

Editorial | 07 October 2020
Scientists, keep an open line of communication with the public
The COVID-19 pandemic has opened up a direct channel between scientists and the public. Keeping it open must become part of scientists’ mission.
aboration can be transformative to research.

Rare diseases band together toward change in research

Nature Medicine
Volume 26 Issue 10, October 2020
https://www.nature.com/nm/volumes/26/issues/10

 

News Feature | 07 October 2020
Rare diseases band together toward change in research
Patients with rare diseases, and the scientists who study those diseases, were long inhibited by geographic sparsity. But the social-media age has made it much easier for them to band together to leverage their experience and push forward change.
Claire Ainsworth

Patient groups and biomedicine: for better and for worse

Nature Medicine
Volume 26 Issue 10, October 2020
https://www.nature.com/nm/volumes/26/issues/10

 

News Feature | 07 October 2020
Patient groups and biomedicine: for better and for worse
In recent years, patient research groups have spurred culture shifts in biomedical research and governance, with many health experts lauding the benefit of these groups’ being embedded in the research process. Some, however, question private-sector influence in these groups’ newfound power.
John Zarocostas

The Human Cell Atlas and equity: lessons learned

Nature Medicine
Volume 26 Issue 10, October 2020
https://www.nature.com/nm/volumes/26/issues/10

 

Comment | 07 October 2020
The Human Cell Atlas and equity: lessons learned
The Human Cell Atlas has been undergoing a massive effort to support global scientific equity. The co-leaders of its Equity Working Group share some lessons learned in the process.
Partha P. Majumder, Musa M. Mhlanga & Alex K. Shalek

Audio Interview: Vaccinology and Covid-19

New England Journal of Medicine
October 15, 2020 Vol. 383 No. 16
http://www.nejm.org/toc/nejm/medical-journal

 

Editorials
Audio Interview: Vaccinology and Covid-19
Eric J. Rubin, M.D., Ph.D., Lindsey R. Baden, M.D., and Stephen Morrissey, Ph.D.
In this audio interview conducted on October 14, 2020, the editors discuss the fundamental concepts behind candidate vaccines against SARS-CoV-2 and the status of ongoing clinical trials.

Risk of disease and willingness to vaccinate in the United States: A population-based survey

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 17 Oct 2020)

 

Research Article
Risk of disease and willingness to vaccinate in the United States: A population-based survey
Vaccination complacency occurs when perceived risks of vaccine-preventable diseases are sufficiently low so that vaccination is no longer perceived as a necessary precaution. Disease outbreaks can once again increase perceptions of risk, thereby decrease vaccine complacency, and in turn decrease vaccine hesitancy. It is not well understood, however, how change in perceived risk translates into change in vaccine hesitancy. We advance the concept of vaccine propensity, which relates a change in willingness to vaccinate with a change in perceived risk of infection—holding fixed other considerations such as vaccine confidence and convenience.
Bert Baumgaertner, Benjamin J. Ridenhour, Florian Justwan, Juliet E. Carlisle, Craig R. Miller
| published 15 Oct 2020 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1003354

Using social media influencers to increase knowledge and positive attitudes toward the flu vaccine

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

 

Research Article
Using social media influencers to increase knowledge and positive attitudes toward the flu vaccine
Erika Bonnevie, Sarah D. Rosenberg, Caitlin Kummeth, Jaclyn Goldbarg, Ellen Wartella, Joe Smyser
Research Article | published 16 Oct 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0240828

How confidence in health care systems affects mobility and compliance during the COVID-19 pandemic

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

 

How confidence in health care systems affects mobility and compliance during the COVID-19 pandemic
Ho Fai Chan, Martin Brumpton, Alison Macintyre, Jefferson Arapoc, David A. Savage, Ahmed Skali, David Stadelmann, Benno Torgler
Research Article | published 15 Oct 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0240644

Leave no child behind: Using data from 1.7 million children from 67 developing countries to measure inequality within and between groups of births and to identify left behind populations

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

 

Leave no child behind: Using data from 1.7 million children from 67 developing countries to measure inequality within and between groups of births and to identify left behind populations
Antonio P. Ramos, Martin J. Flores, Robert E. Weiss
Research Article | published 14 Oct 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0238847

Validity and Reliability Assessment of Attitude Scales for Hepatitis B Vaccination Among Parents in Ho Chi Minh City, Vietnam

Risk Management and Healthcare Policy
https://www.dovepress.com/risk-management-and-healthcare-policy-archive56
[Accessed 17 Oct 2020]

 

Original Research
Validity and Reliability Assessment of Attitude Scales for Hepatitis B Vaccination Among Parents in Ho Chi Minh City, Vietnam
Huynh G, Pham DUB, Nguyen TV, Bui VQ, Nguyen TNH, Nguyen DD, Pham LA
Risk Management and Healthcare Policy 2020, 13:2149-2158
Published Date: 14 October 2020

Ethical Questions Linked to Rare Diseases and Orphan Drugs – A Systematic Review

Risk Management and Healthcare Policy
https://www.dovepress.com/risk-management-and-healthcare-policy-archive56
[Accessed 17 Oct 2020]

 

Original Research
Ethical Questions Linked to Rare Diseases and Orphan Drugs – A Systematic Review
Kacetl J, Marešová P, Maskuriy R, Selamat A
Risk Management and Healthcare Policy 2020, 13:2125-2148
Published Date: 13 October 2020
…The main findings reveal five main ethical issues. The most essential one shows that funding research and development in the field of orphan drugs poses an almost impossible dilemma. Other issues include the significance of non-economic values like compassion and beneficence in decision-making related to orphan drugs and rare diseases; the identification of limits to labelling diseases as rare; barriers to global, supranational and international cooperation; and last but not least, determining and establishing panels of decision-makers.
Conclusions: A strictly global approach would be the most appropriate way to deal with rare diseases. Nonetheless, international, let alone global, cooperation seems to be completely beyond the reach of the current international community, although the EU, for instance, has a centralized procedure for labelling orphan drugs. This deficit in international cooperation can be partly explained by the fact that the current technologically globalized world still lacks globally accepted ethical values and rules. This is further aggravated by unresolved international and intercultural conflicts. In addition, the sub-interests of various parties as well as the lack of desire to deal with other people’s problems need to be taken into account. The aforementioned problems are difficult to avoid. Nevertheless, let us be cautiously optimistic. At least, there are people who raise ethical questions about rare diseases and orphan drugs.

Not throwing away our shot

Science
16 October 2020 Vol 370, Issue 6514
http://www.sciencemag.org/current.dtl

 

Editorial
Not throwing away our shot
By H. Holden Thorp
Science16 Oct 2020 : 266
Summary
Over the past few weeks, prominent scientific publications have condemned President Donald Trump’s record on science. This is unprecedented. Although my predecessors at Science have always held elected U.S. officials accountable (but could not make a formal political endorsement because of the nonprofit status of the American Association for the Advancement of Science, the publisher of Science), many of these publications are now clearly denouncing the U.S. president, administration, and federal agency leaders as the nation approaches a highly consequential presidential election. To paraphrase lyrics by Lin-Manuel Miranda in “Hamilton” about another set of political essays, why do we write like we’re running out of time? Because recent events show that the voice of the scientific community can lead to positive change.

COVID-19 in children and young people

Science
16 October 2020 Vol 370, Issue 6514
http://www.sciencemag.org/current.dtl

 

Perspectives
COVID-19 in children and young people
By Matthew D. Snape, Russell M. Viner
Science16 Oct 2020 : 286-288 Full Access
Children have a low risk of COVID-19 and are disproportionately harmed by precautions
Summary
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has brought distinct challenges to the care of children and adolescents globally. Unusually for a respiratory viral infection, children and adolescents are at much lower risk from symptomatic coronavirus disease 2019 (COVID-19) than any other age group. The near-global closure of schools in response to the pandemic reflected the reasonable expectation from previous respiratory virus outbreaks that children would be a key component of the transmission chain. However, emerging evidence suggests that this is most likely not the case. A minority of children experience a postinfectious inflammatory syndrome, the pathology and long-term outcomes of which are poorly understood. However, relative to their risk of contracting disease, children and adolescents have been disproportionately affected by lockdown measures, and advocates of child health need to ensure that children’s rights to health and social care, mental health support, and education are protected throughout subsequent pandemic waves.

COVID-19 treatment in sub-Saharan Africa: If the best is not available, the available becomes the best

Travel Medicine and Infectious Diseases
Volume 37 September–October 2020
https://www.sciencedirect.com/journal/travel-medicine-and-infectious-disease/vol/37/suppl/C

 

Editorial Full text access
COVID-19 treatment in sub-Saharan Africa: If the best is not available, the available becomes the best
Jan H Dubbink, Tiago Martins Branco, Kelfala BB Kamara, James S Bangura, … Martin Peter Grobusch
Article 101878

Public health implications of Sabarimala mass gathering in India: A multi-dimensional analysis

Travel Medicine and Infectious Diseases
Volume 37 September–October 2020
https://www.sciencedirect.com/journal/travel-medicine-and-infectious-disease/vol/37/suppl/C

 

Research article Abstract only
Public health implications of Sabarimala mass gathering in India: A multi-dimensional analysis
Kesavan Rajasekharan Nayar, Shaffi Fazaludeen Koya, K. Mohandas, Sabari Sivasankaran Nair, … Jinbert Lordson
Article 101783

Factors influencing the immune response after a single-dose 3-visit pre-exposure rabies intradermal vaccination schedule: A retrospective multivariate analysis

Travel Medicine and Infectious Diseases
Volume 37 September–October 2020
https://www.sciencedirect.com/journal/travel-medicine-and-infectious-disease/vol/37/suppl/C

 

Research article Abstract only
Factors influencing the immune response after a single-dose 3-visit pre-exposure rabies intradermal vaccination schedule: A retrospective multivariate analysis
Benjamin Damanet, Diana Isabela Costescu Strachinaru, Mathias Van Nieuwenhove, Patrick Soentjens
Article 101867

Improving the quality and use of immunization and surveillance data: Summary report of the Working Group of the Strategic Advisory Group of Experts on Immunization

Vaccine
Volume 38, Issue 46 Pages 7183-7408 (27 October 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/46

 

Conference info Open access
Improving the quality and use of immunization and surveillance data: Summary report of the Working Group of the Strategic Advisory Group of Experts on Immunization
Heather M. Scobie, Michael Edelstein, Edward Nicol, Ana Morice, … Jaleela Jawad
Pages 7183-7197

Interventions to reduce the burden of vaccine-preventable diseases among migrants and refugees worldwide: A scoping review of published literature, 2006–2018

Vaccine
Volume 38, Issue 46 Pages 7183-7408 (27 October 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/46

 

Review article Abstract only
Interventions to reduce the burden of vaccine-preventable diseases among migrants and refugees worldwide: A scoping review of published literature, 2006–2018
Nadia A. Charania, Nina Gaze, Janice Y. Kung, Stephanie Brooks

Parent, provider and vaccinee preferences for HPV vaccination: A systematic review of discrete choice experiments

Vaccine
Volume 38, Issue 46 Pages 7183-7408 (27 October 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/46

 

Review article Abstract only
Parent, provider and vaccinee preferences for HPV vaccination: A systematic review of discrete choice experiments
Alina Lack, Mickael Hiligsmann, Paul Bloem, Maike Tünneßen, Raymond Hutubess

Immunization governance: Mandatory immunization in 28 Global NITAG Network countries

Vaccine
Volume 38, Issue 46 Pages 7183-7408 (27 October 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/46

 

Research article Full text access
Immunization governance: Mandatory immunization in 28 Global NITAG Network countries
Shawn H.E. Harmon, David E. Faour, Noni E. MacDonald, Janice E. Graham, … Stephanie Shendale
Pages 7258-7267
Abstract
International trends currently favour greater use of mandatory immunization. There has been little academic consideration or comparison of the existence and scope of mandatory immunization internationally. In this paper, we examine mandatory immunization in 28 Global NITAG (National Immunization Technical Advisory Group) Network (GNN) countries, including countries from every WHO region and World Bank income level classification. We found that although mandatory immunization programs, or mandatory elements within broader immunization programs, are relatively common, jurisdictions vary significantly with respect to the immunizations required, population groups affected, grounds for exemptions, and penalties for non-compliance. We also observed some loose associations with geography and income level. Based on these data, we categorized policies into a spectrum ranging from Narrow to Broad scope.

The relationship between parental source of information and knowledge about measles / measles vaccine and vaccine hesitancy

Vaccine
Volume 38, Issue 46 Pages 7183-7408 (27 October 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/46

 

Research article Abstract only
The relationship between parental source of information and knowledge about measles / measles vaccine and vaccine hesitancy
Shai Ashkenazi, Gilat Livni, Adi Klein, Noa Kremer, … Oren Berkowitz

Comparison of immunization systems in Japan and the United States – What can be learned?

Vaccine
Volume 38, Issue 46 Pages 7183-7408 (27 October 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/46

 

Review article Abstract only
Comparison of immunization systems in Japan and the United States – What can be learned?
Tomohiro Katsuta, Charlotte A. Moser, Kristen A. Feemster, Akihiko Saitoh, Paul A. Offit
Pages 7401-7408

The Strange Case of BCG and COVID-19: The Verdict Is Still up in the Air

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 17 Oct 2020)

 

Open Access Perspective
The Strange Case of BCG and COVID-19: The Verdict Is Still up in the Air
by Radha Gopalaswamy, Natarajan Ganesan, Kalamani Velmurugan, Vivekanandhan Aravindhan and Selvakumar Subbian
Vaccines 2020, 8(4), 612; https://doi.org/10.3390/vaccines8040612 – 16 Oct 2020
Abstract
COVID-19, caused by a novel coronavirus, SARS-CoV-2, contributes significantly to the morbidity and mortality in humans worldwide. In the absence of specific vaccines or therapeutics available, COVID-19 cases are managed empirically with the passive immunity approach and repurposing of drugs used for other conditions. Recently, a concept that bacilli Calmette–Guerin (BCG) vaccination could confer protection against COVID-19 has emerged. The foundation for this widespread attention came from several recent articles, including the one by Miller et al. submitted to MedRxiv, a pre-print server. The authors of this article suggest that a correlation exists between countries with a prolonged national BCG vaccination program and the morbidity/mortality due to COVID-19. Further, clinical BCG vaccination trials are currently ongoing in the Netherlands, Australia, the UK, and Germany with the hope of reducing mortality due to COVID-19. Although BCG vaccination helps protect children against tuberculosis, experimental studies have shown that BCG can also elicit a non-specific immune response against viral and non-mycobacterial infections. Here, we summarize the pros and cons of BCG vaccination and critically analyze the evidence provided for the protective effect of BCG against COVID-19 and highlight the confounding factors in these studies

14-year-old Schoolchildren can Consent to Get Vaccinated in Tyrol, Austria: What do They know about Diseases and Vaccinations?

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 17 Oct 2020)

 

Open Access Article
14-year-old Schoolchildren can Consent to Get Vaccinated in Tyrol, Austria: What do They know about Diseases and Vaccinations?
by Peter Kreidl, Maria-Magdalena Breitwieser, Reinhard Würzner and Wegene Borena
Vaccines 2020, 8(4), 610; https://doi.org/10.3390/vaccines8040610 – 15 Oct 2020
Abstract
In Austria, consent to receiving vaccines is regulated at the federal state level and in Tyrol, children aged 14 years are allowed to consent to receiving vaccination. In August 2017, we investigated determinants associated with vaccine hesitancy, having been vaccinated against measles and human papillomavirus (HPV) and the intention to vaccinate among schoolchildren born in 2002 and 2003. Those who consider measles and HPV a severe disease had a significantly higher intention to be vaccinated (prevalence ratio (PR) of 3.5 (95% CI 1.97–6.32) for measles and a PR of 3.2 (95% CI 1.62–6.35) for HPV). One-third of the participants (32.4%; 95% CI 27.8–37.4) were not aware that they are allowed to consent to receiving vaccines. The most common trusted source reported by respondents (n = 311) was the medical doctor (80.7%; 95% CI 75.7–84.7). The main finding related to the aim of the study was that the proportion of objectors is below 4% and therefore it should still be possible to reach measles elimination for which a 95% uptake is necessary. Although the proportion of objectors is not higher compared to adults, we recommend to intensify health education to increase health literacy.

Cholera, the Current Status of Cholera Vaccines and Recommendations for Travellers

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 17 Oct 2020)

 

Open Access Review
Cholera, the Current Status of Cholera Vaccines and Recommendations for Travellers
by Giovanni Gabutti, Andrea Rossanese, Alberto Tomasi, Sandro Giuffrida, Vincenzo Nicosia, Juan Barriga, Caterina Florescu, Federica Sandri and Armando Stefanati
Vaccines 2020, 8(4), 606; https://doi.org/10.3390/vaccines8040606 – 14 Oct 2020
Abstract
Cholera is endemic in approximately 50 countries, primarily in Africa and South and Southeast Asia, and in these areas, it remains a disease associated with poverty. In developed nations, cholera is rare, and cases are typically imported from endemic areas by returning travellers. Cholera is readily preventable with the tools available to modern medicine. In developing nations, cholera transmission can be prevented through improved water, sanitation, and hygiene services and the use of oral cholera vaccines (OCVs). For travellers, risk can be mitigated by practicing regular hand hygiene and consuming food and water from safe sources. OCVs should be considered for high-risk travellers likely to be exposed to cholera patients or contaminated water and food. There are currently three World Health Organization pre-qualified OCVs, which are based on killed whole-cell strains of Vibrio cholerae. These established vaccines offer significant protection in adults and children for up to 2 years. A novel live attenuated vaccine that provides rapid-onset protection in adults and children is licensed in the USA and Europe only. Live attenuated OCVs may mimic the natural infection of V. cholerae more closely, generating rapid immune responses without the need for repeat dosing. These potential benefits have prompted the ongoing development of several additional live attenuated vaccines. The objective of this article is to provide a general review of the current landscape of OCVs, including a discussion of their appropriate use in international travellers.

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 17 Oct 2020
[No new, unique, relevant content]

 

BBC
http://www.bbc.co.uk/
Accessed 17 Oct 2020
Coronavirus Global Update
Queues in China for experimental vaccine
The Covid-19 vaccine is available to the public in the city of Yiwu under an emergency use programme. Also: why flying on an aeroplane during the pandemic may be safer than you might think, and could high doses of vitamin D offer protection against the virus?
Download
Higher quality (128kbps)
Lower quality (64kbps)
Release date: 17 October 2020

 

The Economist
http://www.economist.com/
Accessed 17 Oct 2020
Chaguan
China calls its “heroic” handling of covid-19 proof of its wisdom
A lopsided global recovery amid Chinese bragging could sharpen divisions between China and the West
Oct 17

 

Financial Times
https://www.ft.com/
Accessed 17 Oct 2020
The FT View The editorial board
China’s vaccine diplomacy has broader aims
October 12, 2020
As the US under President Donald Trump retreats from multilateral efforts on climate change and health, so China is rushing to fill the void. First came Xi Jinping’s commitment last month to make his country carbon neutral by 2060. Then late last week Beijing signalled it would join a World Health Organization initiative aimed at ensuring fair distribution of Covid-19 vaccines around the world. Both moves appear part of a wider public relations effort by Beijing to present itself as a good global citizen, and counter souring international perceptions of China. Both leave important questions unanswered. But like the climate move, China’s vaccine commitment deserves — with caveats — to be welcomed.

The Covax initiative aims to provide 2bn Covid-19 vaccinations globally by the end of 2021. Richer economies are asked for donations towards funding vaccine purchases for lower-income countries. They can also commit to pool a portion of their national vaccine procurements with those of the initiative — to increase overall bargaining power and help secure vaccines more cheaply. But amid widespread “vaccine nationalism”, richer countries were initially slow to join up and several of the world’s larger economies, including the US and Russia, remain outside.

Many developed countries have preferred to strike their own exclusive arrangements with vaccine providers — which could leave much of the global population vulnerable, and the virus circulating for longer. Covax has so far garnered pledges of about $1.8bn — far short of the $35bn-plus experts estimate is needed to buy sufficient volumes to cover the world’s population.

The entry of the world’s second-largest economy could help the initiative to gain critical mass, and increase pressure on other holdouts to join up. But there are big details to be filled in — including the size of any Chinese financial contribution and whether it will “pool” part of its own procurement. Some question whether Beijing is seeking to ease approval for vaccines being developed by its companies or gain access to third-party funding for global purchases of those vaccines. They fear China, like Russia, might cut a series of bilateral deals, notably in Africa, bypassing international standards and charging more than pooled purchasing and negotiation could achieve.

China’s success in containing the virus means it is short of Covid-19 patients to include in final-stage, or phase 3, trials of its own vaccine prospects, and needs to co-operate with other countries. Many of its leading vaccine candidates have been given to thousands of people outside the trials process, raising concerns about ethics as well as efficacy. But supplying developing nations is a commercial opportunity for China’s vaccine makers, which produce about a fifth of the world’s vaccines, largely for domestic use.

Joining the vaccine initiative is also a way of being seen to make amends, as the original source of coronavirus, for early mis-steps in containing it; Mr Trump insists he will “make China pay”. Beijing’s engagement contrasts sharply with the US president’s own plan to withdraw from the WHO.

Along with the emissions target, and a sign of willingness to co-operate on multilateral debt forgiveness, the vaccines step appears part of a broader attempt by China to portray itself as a more constructive partner. That cannot obscure the deep concerns over its behaviour, including its treatment of Uighurs, its Hong Kong clampdown, and threatening stance towards Taiwan. After the increase in tensions with the west in recent years, however, any indication of a shift in Beijing’s approach should be seen, with due caution, as positive.

Coronavirus pandemic
WHO chief says lack of global leadership has prolonged pandemic
A lack of leadership from global powers had prolonged the coronavirus pandemic, Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, said on Monday as he called on the world’s biggest economies to “step up”.
“If you take the whole of the UN, it doesn’t work without global leadership by the countries themselves, especially the major powers,” Mr Tedros told the FT’s Africa Summit. Without explicitly criticising any nation, Mr Tedros said the UN’s role was to facilitate, but the power lay in the hands of member countries. “They should step up and lead, which is not the case in this pandemic, which is causing the pandemic to actually continue,” he added.
October 12, 2020
Bottom of Form

 

Forbes
http://www.forbes.com/
Accessed 17 Oct 2020
Oct 17, 2020, 07:07am EDT
Covid-19 Disinformation: Why Russia’s Been Blamed For Bizarre Vaccine Conspiracy Theory
James Rodgers Senior Contributor
The race to create—and then sell—a coronavirus vaccine is not just the number one priority in global healthcare. It is now a battleground in global politics.
Even taking that into account, the latest reported development in the propaganda war surrounding this most keenly-contested competition is, frankly, bizarre…

Oct 16, 2020
Pfizer Will Seek Emergency Approval For Covid-19 Vaccine In November, After Election
The U.S. Food and Drug Administration needs at least two months of safety data before authorizing emergency use of any experimental Covid-19 vaccine.
By Robert Hart Forbes Staff

Oct 15, 2020
Fauci Attacks Herd Immunity Declaration Embraced By White House As ‘Total Nonsense’
The Great Barrington Declaration says authorities should let Covid-19 spread uncontrollably through low-risk populations
By Robert Hart Forbes Staff

Oct 14, 2020
Fauci Ramps Up War Of Words With Trump, Warns Rallies Pose Covid Risk
Fauci said Trump’s crowded rallies with few masks are a ‘potential problem,’ while contradicting his claims on immunity and a vaccine timeline.
By Andrew Solender Forbes Staff

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 17 Oct 2020
[No new, unique, relevant content]

 

Foreign Policy
http://foreignpolicy.com/
Accessed 17 Oct 2020
[No new, unique, relevant content]

 

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

 

New Yorker
http://www.newyorker.com/
Politics and More Podcast
Anthony Fauci, Then and Now
Dr. Fauci, who has been the face of establishment science during the AIDS and coronavirus crises, speaks with Michael Specter about his career as a lightning rod for criticism.
By Dorothy Wickenden
October 12, 2020

 

New York Times
http://www.nytimes.com/
Accessed 17 Oct 2020
Health
First, a Vaccine Approval. Then ‘Chaos and Confusion.’
Come spring, Americans may have their choice of several so-so coronavirus vaccines — with no way of knowing which one is best.
By Carl Zimmer

 

Washington Post
https://www.washingtonpost.com/
Accessed 17 Oct 2020
China rapidly expands use of experimental COVID-19 vaccines
TAIPEI, Taiwan — China is rapidly increasing the number of people receiving its experimental coronavirus vaccines, with a city offering one to the general public and a biotech company providing another free to students going abroad.
The city of Jiaxing, south of Shanghai, is offering a vaccine under development by Sinovac, it said in an announcement Thursday. It said high-risk groups, including people who are “responsible for the basic operations of the city” will receive priority, but that residents who have emergency needs can also sign up.
The vaccine is in the final stage of clinical testing, but has not yet been approved. The city government said it is being provided under an emergency authorization.
China National Biotech Group, another Chinese vaccine company, is offering its vaccine free to students who study abroad in a strategy health experts say raises safety and ethical concerns.
Oct 16, 2020

Think Tanks et al

Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 17 Oct 2020
TechTank
Reimagining innovation to navigate COVID-19
Joseph Kannarkat and Norman Augustine
Friday, October 16, 2020
 
 

Center for Global Development [to 17 Oct 2020]
http://www.cgdev.org/page/press-center
October 14, 2020
Making the $12 Billion Go Further: Four Things the World Bank Can Do in Support of COVID-19 Vaccination Efforts
To maximise the impact of this badly needed investment to combat COVID and, most importantly, to avoid any perverse and potentially catastrophic implications of World Bank financing undermining current global efforts led by Gavi and CEPI, we propose that the World Bank commit to the four principles below.
Kalipso Chalkidou, Prashant Yadav and Amanda Glassman

October 12, 2020
New Data Show the World Bank’s COVID Response Is Too Small and Too Slow
The World Bank has committed to providing $104 billion in financing by next June to help developing countries deal with the COVID-19 crisis. Is that sufficient to meet the needs of developing countries facing a massive growth contraction? And will the bank actually deliver on its pledge?
Julian Duggan et al.
 
 

Chatham House [to 17 Oct 2020]
https://www.chathamhouse.org/
[No new relevant content]

 

CSIS
https://www.csis.org/
Accessed 17 Oct 2020
Upcoming Event
CSIS Press Briefing: Public Trust in a Covid-19 Vaccine
October 20, 2020
In this call, CSIS’s J. Stephen Morrison and Katherine Bliss and the London School’s Heidi Larson will discuss the proposal and its recommendations for effectively combating vaccine misinformation.

Report
What Can the United States Do to Prevent Another Pandemic? Commit to Modernizing Influenza Vaccines
October 14, 2020

 
 

Council on Foreign Relations
http://www.cfr.org/
Accessed 17 Oct 2020
[No new relevant content]

 
 

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 17 Oct 2020
October 13, 2020 News Release
New Nationwide Poll by the Kaiser Family Foundation and The Undefeated Reveals Distrust of the Health Care System Among Black Americans
Half of African Americans say they will not take a coronavirus vaccine KFF/The Undefeated poll shows disparate views on health care between Black and white America

Vaccines and Global Health: The Week in Review :: 10 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

Vaccines and Global Health: The Week in Review :: 26 September 2020

Posted on 

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_26-sep-2020Download

– 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

Lancet COVID-19 Commission Statement on the occasion of the 75th session of the UN General Assembly

Featured Journal Content

Lancet COVID-19 Commission Statement on the occasion of the 75th session of the UN General Assembly
The Lancet COVID-19 Commissioners, Task Force Chairs, and Commission Secretariat
[Editor’s text bolding in red]
Executive summary
The Lancet COVID-19 Commission was launched on July 9, 2020, to assist governments, civil society, and UN institutions in responding effectively to the COVID-19 pandemic. The Commission aims to offer practical solutions to the four main global challenges posed by the pandemic: suppressing the pandemic by means of pharmaceutical and non-pharmaceutical interventions; overcoming humanitarian emergencies, including poverty, hunger, and mental distress, caused by the pandemic; restructuring public and private finances in the wake of the pandemic; and rebuilding the world economy in an inclusive, resilient, and sustainable way that is aligned with the Sustainable Development Goals (SDGs) and the Paris Climate Agreement. Many creative solutions are already being implemented, and a key aim of the Commission is to accelerate their adoption worldwide.

 

The origins of COVID-19 and averting zoonotic pandemics
The COVID-19 pandemic is the latest—but certainly not the last—emerging infectious disease, preceded by HIV/AIDS, Nipah, severe acute respiratory syndrome coronavirus, H1N1 influenza, Middle East respiratory syndrome coronavirus, Zika, Ebola, and others. These diseases are zoonoses, resulting from pathogens being transmitted from animals to humans. To protect against zoonoses, we require new precautions, such as ending deforestation and protecting conservation areas and endangered species. The origins of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are yet to be definitively determined, but evidence to date supports the view that SARS-CoV-2 is a naturally occurring virus rather than the result of laboratory creation and release. Research into the origins of SARS-CoV-2 should proceed expeditiously, scientifically, and objectively, unhindered by geopolitical agendas and misinformation.

 

The urgency of suppressing the pandemic
The COVID-19 epidemic can and should be suppressed through non-pharmaceutical interventions, including effective community health services, that cut transmission of the virus, to be followed by the introduction of effective and safe vaccines as rapidly as science permits. Countries should not rely on herd immunity by natural infection to suppress the epidemic. The disease and death that would accompany natural infection rates to reach herd immunity, typically estimated as 40–60% of the population infected, would be unacceptably high. Uncertainty also remains about the duration of acquired immunity from past infections.

The great divide in the outcomes of the epidemic has been the relative success of the Asia–Pacific region compared with western Europe and the Americas. The Asia–Pacific region has largely suppressed transmission and mortality (less than 10 deaths per million). Western Europe and the Americas have had very high transmission and mortality (several hundred deaths per million in several countries). Many low-income countries have suppressed the epidemic, such as Cambodia, Lao People’s Democratic Republic, and Viet Nam.

To implement non-pharmaceutical interventions, we urge countries to scale up with all urgency their public health workforces, including epidemiologists, public health technicians, nurses, testers, contact tracers, and community health workers. Community health workers can contribute to controlling community spread and protecting vulnerable people in the community, particularly through testing, education on prevention and treatment, and education on the mental health effects of social isolation.

The vexing question of whether to close schools is perhaps the single most challenging non-pharmaceutical intervention. Schools can safely reopen when community transmission is low and school facilities and staff have been appropriately prepared. When it is not safe to open schools, countries and localities should aim to implement online education accessible to all students.

 

Health professionalism
One reason for failure to suppress the epidemic is a style of political leadership that has been called medical populism; Lasco has described political leaders as “simplifying the pandemic by downplaying its impacts or touting easy solutions or treatments, spectacularizing their responses to crisis, forging divisions between the ‘people’ and dangerous ‘others’, and making medical knowledge claims to support the above”. Lasco makes three cases in point: the US President, Donald Trump, the Philippine President, Rodrigo Duterte, and the Brazilian President, Jair Bolsonaro.

We call on governments to prioritise advice from the professional public health community, working in cooperation with international agencies and learning from the best practices of other nations. All countries should combat decisions based on rumour-mongering and misinformation. Leaders should desist from expressing personal viewpoints that are at odds with science.

 

Addressing the inequities of the epidemic
The COVID-19 pandemic is bringing to light and exacerbating pre-existing social, economic, and political inequalities, including inequalities of wealth, health, wellbeing, social protection, and access to basic needs including food, health care, and schooling. The pandemic is bringing about a sharp increase in income inequality and jobs crises for low-paid workers. Health inequalities also pose major issues in this pandemic; as of December, 2017, half of the world’s population did not have access to essential health services. Vulnerable populations (including the poor, older people, people with previous health conditions, people who are incarcerated, refugees, and Indigenous peoples) are bearing a disproportionate burden of the pandemic.

The abrupt shift to an online economy came in the context of a deep, pre-existing digital divide in high-quality digital access. We call on all relevant UN agencies to take concrete steps with the digital industry and governments to accelerate universal access to digital services, including public–private financing to extend connectivity to hard-to-reach populations.

Among the most urgent challenges of the COVID-19 pandemic are hunger and food insecurity for poor and vulnerable populations. The pandemic also poses great concerns for mental health, especially for lower-income populations, and there is high inequality in the provision of services for mental health, especially in lower-income and middle-income countries. The gender dimensions of COVID-19 must also be prioritised, in recognition of the documented increase in unplanned pregnancies for teenage and young women, and the increase in gender-based violence.

 

Data needs
The UN Statistical Commission, working with partner UN institutions and with national statistical agencies, should prepare near-real-time data on highly vulnerable populations and their conditions, with a special focus on infection and death rates, poverty, joblessness, mental health, violence, hunger, forced labour, and other forms of extreme deprivation and abuses of human rights. Urgent surveying should be undertaken to identify humanitarian needs and hunger hotspots, especially among the poor, older people, people living with disabilities, Indigenous peoples, women who are vulnerable, young children, refugees, people who are incarcerated, people working in high-risk jobs (eg, meatpacking plants or guest workers), and other minority populations (including ethnic, racial, and religious minorities).

 

Meeting the urgent fiscal needs of the developing countries
One of the characteristics of the global crisis is the sharp drop in public revenues at all government levels. The situation for developing countries will become increasingly dire as many countries find themselves facing rising social needs without the means to finance social services. Moreover, many developing countries currently do not have the kinds of social protection programmes that are most urgently needed at this juncture, such as unemployment insurance, income support, and nutrition support.

Some developing countries will require considerable international concessional financing (ie, grants and low-interest, long-term loans) from the international financing institutions, notably the International Monetary Fund, the World Bank, and the multilateral and regional development banks, as well as the orderly restructuring of their sovereign debts to both public and private creditors. Now, more than ever, is the time for countries to meet their commitments to providing 0·7% of gross domestic product as official development aid. Special efforts must be made to fight corruption, to ensure that new aid flows reach the intended beneficiaries.

 

Global justice in access to safe and effective vaccines, therapeutics, diagnostics, and equipment
The pharmaceutical industry and academic community, supported by governments, have undertaken a remarkable effort to develop new approaches for the suppression of the pandemic, including vaccines, therapeutics, rapid diagnostics, and treatment regimens. The introduction of new vaccines and therapeutics should follow rigorous testing and evaluation through all clinical phases and must not be subject to dangerous political interference.

In the early phases of the COVID-19 pandemic, there have already been breakdowns in the global health governance of vaccine development, even leading to the new term vaccine nationalism. Any new vaccine or therapeutic must be developed and implemented with a view to equitable access across and within countries. No population should be prohibited from accessing a vaccine because of cost or have its access predicated on its participation in clinical trials. We strongly support the multilateral initiative Access to COVID-19 Tools Accelerator to promote the universal, equitable access to COVID-19 vaccines, therapeutics, and other tools, and within that initiative, COVAX Facility, the vaccine pillar. Complementary approaches in support of this multilateral initiative would help to strengthen equitable access across and within countries.

 

Promoting a jobs-based green recovery
Economic recovery plans should support the transition towards sustainable and inclusive societies based on the SDGs and the Paris Climate Agreement. Public investment should be oriented towards sustainable industries and the digital economy, and should spur complementary private investments. Preventing a wave of bankruptcies among small and medium-sized businesses with viable prospects is an important priority. A major goal of the recovery should be an unprecedented commitment to reskilling and upskilling people, including the skills to prepare workers for the digital economy.

The EU Green Deal, long-term budget (2021–27), and new recovery fund marks an exemplary framework for long-term recovery, including mid-century goals on climate safety, energy transition, and circular economy, with a comprehensive €1·8 trillion budget. This approach can serve as an exemplar for other regions. In general, recoveries should be smart (based on digital technologies), inclusive (targeting lower-income households), and sustainable (featuring investments in clean energy and reduced pollution).

 

Multilateralism and the UN system
Global recovery will be greatly facilitated by cooperation at the regional and international level, both in controlling the epidemic and in adopting new green recovery programmes. We strongly urge the United States, EU, China, Russia, India, Mercosur, the African Union, the Association of Southeast Asian Nations, the Community of Latin American and Caribbean States, the Caribbean Community, and other nations and regional groupings to put aside rivalries and beggar-thy-neighbour policies (such as trade and financial sanctions) in favour of coordinated regional responses. Trade and financial sanctions, or other isolationist policies, and talk of a new cold war between the United States and China, are dangerous for global recovery and peace.

The COVID-19 pandemic hit during the 75th anniversary year of the UN. The indispensable role of the UN has been evident throughout the course of the pandemic to date, especially for the world’s most vulnerable populations, and yet the UN system is also under attack and international law has been undermined. We strongly support the UN and call on all nations to honour the UN Charter and the Universal Declaration of Human Rights, and to contribute to the efficacy of the UN multilateral system, including through crucial financing of UN institutions. We call on the United States to reverse its decisions to withdraw from the WHO, the Paris Climate Agreement, the UN Educational, Scientific and Cultural Organisation, and the UN Human Rights Council.

We strongly support the unique role of the International Monetary Fund, the World Bank, and multilateral development banks in providing urgent financing and technical assistance for emerging and developing economies. We call on their shareholders to consider scaling up the already unprecedented efforts at securing larger financing for these countries through an increased allocation or more efficient use of special drawing rights, or through debt restructuring when needed. We also urge the more affluent shareholder countries to provide additional concessional resources.

We strongly support the indispensable role of the WHO in controlling the COVID-19 pandemic, and call on all nations to increase, rather than decrease, their funding support and political backing for the work of the WHO at this fraught time. In this regard, we also support the call for an independent analysis of the WHO response, to strengthen the institution and its central, unique role in global public health.

 

Future work of The Lancet COVID-19 Commission
The Lancet COVID-19 Commission will monitor the global progress in suppressing the pandemic and making an inclusive and sustainable recovery with a new set of metrics that it will regularly publish. The Commission Task Forces will consider in detail many of the complex issues already raised, including the best ways to promote decent jobs and sustainable development. The ten priority actions of the Commission are summarised in panel 1. The next scheduled Statement of the Commission will be in early 2021.

 

[Panel 1] Ten priority actions
1 Origins: track down the origins of the virus in an open, scientific, and unbiased way not influenced by geopolitical agendas

2 Non-pharmaceutical interventions: suppress the epidemic through the proven package of non-pharmaceutical interventions, as accomplished by several countries including several in the Asia–Pacific region

3 Science-based policy making: base policy making on objective scientific evidence and stop politicians and others in positions of power from subverting clinical trials and other scientific protocols

4 Timely and consistent data: collect and publish timely and internationally consistent data on the state of the pandemic, including humanitarian and economic consequences

5 Justice in access to tools to fight COVID-19: ensure universal access to the tools to fight COVID-19, including test kits, therapeutics, and prospective vaccines

6 Emergency financing: secure access of developing countries to financing from international sources, especially from the International Monetary Fund and World Bank

7 Protect vulnerable groups: direct urgent protection towards vulnerable groups, including older people, people in poverty and hunger, women who are vulnerable, children, people with chronic diseases and disabilities, the homeless, migrants, refugees, Indigenous Peoples, and ethnic and racial minorities

8 Long-term financial reform: prepare for a deep restructuring of global finances, including debt relief, new forms of international financing, and reform of monetary arrangements

9 Green and resilient recovery: economic recovery will be based on public-investment-led growth in green, digital, and inclusive technologies, based on the Sustainable Development Goals

10 Global peace and cooperation: support UN institutions and the UN Charter, resisting any attempts at a new cold war

Dying in a Leadership Vacuum

Featured Journal Content

 

New England Journal of Medicine
October 8, 2020
N Engl J Med 2020; 383:1479-1480
DOI: 10.1056/NEJMe2029812
Editorial
Dying in a Leadership Vacuum
The Editors
Covid-19 has created a crisis throughout the world. This crisis has produced a test of leadership. With no good options to combat a novel pathogen, countries were forced to make hard choices about how to respond. Here in the United States, our leaders have failed that test. They have taken a crisis and turned it into a tragedy.

The magnitude of this failure is astonishing. According to the Johns Hopkins Center for Systems Science and Engineering,1 the United States leads the world in Covid-19 cases and in deaths due to the disease, far exceeding the numbers in much larger countries, such as China. The death rate in this country is more than double that of Canada, exceeds that of Japan, a country with a vulnerable and elderly population, by a factor of almost 50, and even dwarfs the rates in lower-middle-income countries, such as Vietnam, by a factor of almost 2000. Covid-19 is an overwhelming challenge, and many factors contribute to its severity. But the one we can control is how we behave. And in the United States we have consistently behaved poorly.

We know that we could have done better. China, faced with the first outbreak, chose strict quarantine and isolation after an initial delay. These measures were severe but effective, essentially eliminating transmission at the point where the outbreak began and reducing the death rate to a reported 3 per million, as compared with more than 500 per million in the United States. Countries that had far more exchange with China, such as Singapore and South Korea, began intensive testing early, along with aggressive contact tracing and appropriate isolation, and have had relatively small outbreaks. And New Zealand has used these same measures, together with its geographic advantages, to come close to eliminating the disease, something that has allowed that country to limit the time of closure and to largely reopen society to a prepandemic level. In general, not only have many democracies done better than the United States, but they have also outperformed us by orders of magnitude.

Why has the United States handled this pandemic so badly? We have failed at almost every step. We had ample warning, but when the disease first arrived, we were incapable of testing effectively and couldn’t provide even the most basic personal protective equipment to health care workers and the general public. And we continue to be way behind the curve in testing. While the absolute numbers of tests have increased substantially, the more useful metric is the number of tests performed per infected person, a rate that puts us far down the international list, below such places as Kazakhstan, Zimbabwe, and Ethiopia, countries that cannot boast the biomedical infrastructure or the manufacturing capacity that we have.2 Moreover, a lack of emphasis on developing capacity has meant that U.S. test results are often long delayed, rendering the results useless for disease control.

Although we tend to focus on technology, most of the interventions that have large effects are not complicated. The United States instituted quarantine and isolation measures late and inconsistently, often without any effort to enforce them, after the disease had spread substantially in many communities. Our rules on social distancing have in many places been lackadaisical at best, with loosening of restrictions long before adequate disease control had been achieved. And in much of the country, people simply don’t wear masks, largely because our leaders have stated outright that masks are political tools rather than effective infection control measures. The government has appropriately invested heavily in vaccine development, but its rhetoric has politicized the development process and led to growing public distrust.

The United States came into this crisis with enormous advantages. Along with tremendous manufacturing capacity, we have a biomedical research system that is the envy of the world. We have enormous expertise in public health, health policy, and basic biology and have consistently been able to turn that expertise into new therapies and preventive measures. And much of that national expertise resides in government institutions. Yet our leaders have largely chosen to ignore and even denigrate experts.

The response of our nation’s leaders has been consistently inadequate. The federal government has largely abandoned disease control to the states. Governors have varied in their responses, not so much by party as by competence. But whatever their competence, governors do not have the tools that Washington controls. Instead of using those tools, the federal government has undermined them. The Centers for Disease Control and Prevention, which was the world’s leading disease response organization, has been eviscerated and has suffered dramatic testing and policy failures. The National Institutes of Health have played a key role in vaccine development but have been excluded from much crucial government decision making. And the Food and Drug Administration has been shamefully politicized,3 appearing to respond to pressure from the administration rather than scientific evidence. Our current leaders have undercut trust in science and in government,4 causing damage that will certainly outlast them. Instead of relying on expertise, the administration has turned to uninformed “opinion leaders” and charlatans who obscure the truth and facilitate the promulgation of outright lies.

Let’s be clear about the cost of not taking even simple measures. An outbreak that has disproportionately affected communities of color has exacerbated the tensions associated with inequality. Many of our children are missing school at critical times in their social and intellectual development. The hard work of health care professionals, who have put their lives on the line, has not been used wisely. Our current leadership takes pride in the economy, but while most of the world has opened up to some extent, the United States still suffers from disease rates that have prevented many businesses from reopening, with a resultant loss of hundreds of billions of dollars and millions of jobs. And more than 200,000 Americans have died. Some deaths from Covid-19 were unavoidable. But, although it is impossible to project the precise number of additional American lives lost because of weak and inappropriate government policies, it is at least in the tens of thousands in a pandemic that has already killed more Americans than any conflict since World War II.

Anyone else who recklessly squandered lives and money in this way would be suffering legal consequences. Our leaders have largely claimed immunity for their actions. But this election gives us the power to render judgment. Reasonable people will certainly disagree about the many political positions taken by candidates. But truth is neither liberal nor conservative. When it comes to the response to the largest public health crisis of our time, our current political leaders have demonstrated that they are dangerously incompetent. We should not abet them and enable the deaths of thousands more Americans by allowing them to keep their jobs.

China commits to sharing vaccines

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COVAX

China commits to sharing vaccines
Updated: 2020-10-10 | China Daily
Decision to join global effort expected to bolster access to COVID immunization
China has joined the COVID-19 Vaccines Global Access Facility, an important step to advance the building of a global community of health for all, the Foreign Ministry said on Oct 9.

Ministry spokeswoman Hua Chunying said the move shows that China honors its commitment to turn COVID-19 vaccines into a global public good.

Hua’s remarks, in a statement on the ministry’s website, came after China signed an agreement with the Global Alliance for Vaccines and Immunization on its participation in the COVAX facility on Thursday.

“Even when China is leading the world with several vaccines in advanced stages of R&D and with ample production capacity, it still decided to join COVAX,” Hua said.

“We are taking this concrete step to ensure equitable distribution of vaccines, especially to developing countries, and hope other capable countries will also join and support COVAX,” she said. China will strengthen vaccine cooperation with other countries through the COVAX network, she said.

With the COVID-19 pandemic still posing a severe threat to all countries, Hua stated that China will continue to work together with COVAX partners and contribute its share to the global fight against the pandemic to safeguard the safety and health of everyone…

COVID-19 Vaccines and Therapeutics: Regulatory Integrity

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COVID-19 Vaccines and Therapeutics: Regulatory Integrity

News: EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines
Last updated: 05/10/2020
The European Medicines Agency (EMA) has re-affirmed today that it will uphold its long-standing commitment to independence and transparency in its evaluation of COVID-19 treatments and vaccines.

In an open letter sent to European Ombudsman Emily O’Reilly in response to an enquiry on the role of EMA and its pandemic task force during the COVID-19 crisis, the Agency explains that it is applying the same independence measures to its experts dealing with COVID-19 treatments and vaccines as it does for those dealing with all medicines. This includes the experts involved in providing advice on these medicines’ development, as well as the experts evaluating them.

 

These tried and tested measures ensure that EMA’s recommendations are driven only by science and public-health needs, and not by any other interests.

The letter also sets out the Agency’s transparency plans for COVID-19 treatments and vaccines. EMA will publish the clinical data underpinning its recommendations for all COVID-19 medicines. This falls under the scope of EMA’s landmark policy on proactive publication of clinical data, which the Agency is reinstating – exclusively for COVID-19 medicines at this point – following its suspension in August 2018 to allow the Agency to focus resources on its relocation from the United Kingdom to the Netherlands.

Because EMA considers maximum transparency as a pre-condition for fostering trust and confidence in the EU regulatory system, it is also planning a range of additional measures to provide the public prompt insights into its development and safety-monitoring processes. This includes for example the publication of the product information with details of the conditions of use even before the formal marketing authorisation will be granted, the expedited publication of the full European Public Assessment Report (EPAR) and the publication of the risk management plans for authorised COVID-19 medicines in their entirety, rather than as a summary.

The scale of the COVID-19 public health crisis has led to unprecedented efforts by all those involved in the development of medicines to treat and prevent COVID-19, compressing a process that typically requires several years into one lasting only several months.

EMA and the national competent authorities have responded to these challenges by fully mobilising their resources to expedite their advice and evaluation processes, while maintaining their safety and efficacy standards and applying tested independence and transparency rules.

COVID-19 Vaccines – New FDA Guidance and Webpage

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COVID-19 Vaccines – New FDA Guidance and Webpage

Guidance for Industry: Emergency Use Authorization for Vaccines to Prevent COVID-19
October 2020
Docket Number: 2020-D-1137
Issued by: Center for Biologics Evaluation and Research
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic.  FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.
PDF: https://www.fda.gov/media/142749/download
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)): https://www.regulations.gov/docket?D=2020-D-1137

FDA In Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines
10/06/2020
…Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research: “Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available. The FDA’s new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision. In addition to outlining our expectations for vaccine sponsors, we also hope the agency’s guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved.”
Additional Information
:: Today, the U.S. Food and Drug Administration issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19.

:: The recommendations in the guidance describe key information and data that would support issuance of an EUA, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information.

:: This guidance provides further information on the EUA process for investigational vaccines and provides additional context to the information provided in the agency’s June guidance regarding the development and licensure of COVID-19 vaccines.

:: An EUA is a different standard than an approval, as noted in the June guidance, however, in the case of an investigational vaccine developed for the prevention of COVID-19, both pathways require the submission of data demonstrating any vaccine’s safety and effectiveness.

:: This guidance reiterates that any assessment regarding an EUA will be made on a case-by-case basis considering the target population, the characteristics of the product, the preclinical and human clinical study data on the product, and the totality of the available scientific evidence relevant to the product.

:: The FDA plans to convene an open session of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) prior to issuance of any EUA for a COVID-19 vaccine to discuss the EUA request and whether the available safety and effectiveness data support the authorization. The VRBPAC is currently scheduled to meet on Oct. 22 to discuss the general development, authorization and/or licensure of COVID-19 vaccines. While this meeting is not intended to discuss any particular vaccine candidate, the agency is prepared to rapidly schedule additional future meetings of this committee after submission of any BLA or request for EUA to further ensure transparency.

 

::::::

FDA launched a new webpage at www.fda.gov/covid19vaccines to highlight new information as it becomes available.

MSF supports India and South Africa ask to waive COVID-19 patent rights

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COVID-19 and IP

MSF supports India and South Africa ask to waive COVID-19 patent rights
Press Release 7 Oct 2020
Geneva – In a landmark move, India and South Africa on 2 October asked the World Trade Organization (WTO) to allow all countries to choose to neither grant nor enforce patents and other intellectual property (IP) related to COVID-19 drugs, vaccines, diagnostics and other technologies for the duration of the pandemic, until global herd immunity is achieved. This bold step is akin to efforts by governments nearly 20 years ago, which spearheaded the use of affordable generic HIV/AIDS medicines, and, if approved, could signal a major turning point in countries’ response to the pandemic, according to Médecins Sans Frontières (MSF).

In the context of the COVID-19 pandemic, MSF called on all governments to support this waiver request at the WTO, whose TRIPS Council (Trade-related Aspects of Intellectual Property Rights Agreement) is meeting on 15 October to start building consensus on the issue.

“A global pandemic is no time for business-as-usual, and there is no place for patents or corporate profiteering as long as the world is faced with the threat of COVID-19,” said Leena Menghaney, South Asia Head of MSF’s Access Campaign. “During the pandemic, treatment providers and governments have had to grapple with intellectual property barriers to essential products such as masks, ventilator valves and reagents for test kits.”

“With this bold action, India and South Africa have shown that governments want to be back in the driver’s seat when it comes to ensuring all people can have access to needed COVID-19 medical products, medicines and vaccines, so that more lives can be saved,” said Menghaney.

WTO member countries can seek a waiver from certain obligations in WTO treaties under exceptional circumstances. If members agree on the waiver, countries can choose not to grant or enforce IP (patents, industrial designs, copyright and trade secrets) related to all COVID-19 medical products and technologies…

COVID 19 Vaccine Programs Update

Featured Journal Content

 

COVID 19 Vaccine Programs Update

Johnson & Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen’s COVID-19 Vaccine Candidate
Oct 08, 2020
Agreement provides option for European Union Member States to secure up to 200 million additional doses for a total of up to 400 million doses
NEW BRUNSWICK, N.J., Oct. 8, 2020 /PRNewswire/ Johnson & Johnson (NYSE: JNJ) (the Company) today announced the European Commission (EC), acting on behalf of the European Union (EU) Member States, has approved an Advance Purchase Agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine ..
candidate to EU Member States following approval or authorization from regulators. The EU Member States also have the option to secure up to 200 million additional doses…

DARPA Awards Moderna up to $56 Million to Enable Small-Scale, Rapid Mobile Manufacturing of Nucleic Acid Vaccines and Therapeutics
October 08, 2020
Award part of DARPA’s Nucleic Acids On-Demand World-Wide (NOW) initiative to develop a medical countermeasure manufacturing platform.
…Award involves development of a mobile manufacturing protype leveraging Moderna’s existing manufacturing technology that is capable of rapidly producing vaccines and therapeutics.

Moderna Announces Updates on Respiratory Syncytial Virus (RSV) Vaccine Program
October 08, 2020
Moderna regains rights to adult RSV vaccine program from Merck
Start of Phase 1 dosing for mRNA-1345, Moderna’s vaccine candidate against RSV 
Moderna has consolidated all rights to its prophylactic vaccines portfolio
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 it has regained all rights to the respiratory syncytial virus (RSV) vaccine (mRNA-1172) from Merck, known as MSD outside the United States and Canada, including rights to develop RSV vaccines for adult populations. mRNA-1172, which uses a Merck lipid nanoparticle for delivery, entered Phase 1 development in 2019. Under the terms of the agreement, Merck will complete the Phase 1 study and transition the program to Moderna. Moderna has now consolidated all global commercial rights to all development candidates in its core prophylactic vaccines modality…

Accenture Launches Vaccine Management Solution to Support COVID-19 Immunization Programs
October 07, 2020
Solution includes modular components to fit varying public health authorities’ needs and priorities
NEW YORK–(BUSINESS WIRE)–Accenture (NYSE: ACN) today announced a comprehensive vaccine management solution to help government and healthcare organizations rapidly and effectively plan and develop COVID-19 vaccination programs and related distribution and communication initiatives.
The solution expands on Accenture’s contact tracing capability to help public health jurisdictions meet newly released guidelines from the U.S. Centers for Disease Control and Prevention (CDC) in preparation for COVID-19 vaccine distribution. It brings together Accenture’s industry, analytics and consulting experience and includes components built on the Salesforce platform. Local, state and national governments as well as healthcare organizations worldwide are expected to similarly undertake planning, development, coordination, distribution and management of COVID-19 immunization programs…

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 :: 36 754 395 [week ago: 34 495 176]
Confirmed deaths :: 1 064 838 [week ago 1 025 729]
Countries, areas or territories with cases :: 235

Weekly Epidemiological Update
Coronavirus disease 2019 (COVID-19)
5 October 2020
Global epidemiological situation
The number of new cases per week has remained stable at 2 million for the past three weeks (Figure 1), with the cumulative total of over 34.8 million cases. Over 1 million deaths have now been reported globally, of which the majority were reported in the Region of the Americas (55%), followed by Europe (23%). In the past week, the regions of the Americas, South-East Asia, and Europe account for 91% of new cases. Five countries (namely India, the United States of America, Brazil, Argentina and France) reported 60% of new global cases this past week, while Israel registered the highest incidence (3717 new cases per 1 million population). Globally, the highest percentage of cases have been reported in the 25-39 age group, with approximately 50% of cases in the 25-64 age group. However, the percentage of deaths increases with age, and approximately 75% of deaths are in those aged 65 years and above.

Although globally the number of new cases was similar to the number of cases in the previous week, there is considerable variation on a country- by-country basis. In several countries, the number of new cases is rising again, and in many (most notably within the European Region) the second wave is exceeding previous peaks; this can be partly attributed to enhancements in surveillance capacities over time. In other countries we have seen a gradual decline in new cases from earlier peaks in August, for example in Brazil, Colombia and Peru. In India and the Philippines, the number of new cases appear to have stabilized, but they are still reporting high numbers. There are also examples of countries that have consistently shown an increasing incidence as their first wave continues; these include Indonesia, Iraq, and Myanmar, although Indonesia is reporting a slight drop this week. South Africa and Australia are examples of countries that have successfully managed to reduce the number of new cases and have seen large reductions from earlier peaks.

 

Key weekly updates
:: Diagnostics: WHO issued the first and second Emergency Use Listing for a quality antigen based rapid diagnostic test. WHO published guidance highlights the value of these tests in areas where community transmission is widespread and where nucleic acid amplification-based diagnostic testing is either unavailable or where test results are significantly delayed. On 28 September, the Access to COVID-19 Tools (ACT) Accelerator announced 120 million high-quality, affordable COVID-19 antigen rapid tests to be made available to low- and middle-income countries.

:: Diagnostics: WHO published the final version of Target Product Profiles (TPP) for priority diagnostics. These TPPs describe the desirable and minimal acceptable profiles for four tests: (i) point of care tests for suspected cases and their close contacts where reference assay testing is unavailable, or turnaround times obviate clinical utility; (ii) tests for diagnosis or confirmation of acute or subacute infection, suitable for low or high-volume needs; (iii) point of care test for prior infection; and (iv) tests for prior infection for moderate to high volume needs.

:: COVAX: The Director-General Dr Tedros, in his regular media briefing on 2 October, highlighted 168 have joined COVAX. Through the ACT Accelerator and COVAX Facility, any vaccines that are proven to be safe and effective will be rolled out equitably across the world.

:: International Day of Older Persons: On 1 October, the International Day of Older Persons, WHO launched a package of tools, including a digital application to help health and social workers provide better care for older people . A data portal was also launched that will compile data on global indicators for monitoring the health and well-being of people aged 60 and over. Globally, older persons and those receiving long term care, accounts for a majority of COVID-19 severe cases and deaths.

:: Mental Health: Billions of people around the world have been affected by the COVID-19 pandemic, which is having an added impact on people’s mental health. On 10 October, World Mental Health Day, WHO is organizing a Big Event for Mental Health. The advocacy event will focus on the urgent need to address the world’s chronic under-investment in mental health – a problem that has been thrown into the spotlight during the COVID-19 pandemic.

:: Preparedness: During the United Nations General Assembly, a high-level event on ‘Sustainable preparedness for health security and resilience: Adopting a whole-of-society approach and breaking the “panic-then-forget” cycle’ was organized and co-hosted by Finland, France and Indonesia, along with the WHO. As the world crossed a grim milestone with over a million lives lost to COVID-19, with many more expected to have died from unprecedented disruptions to health systems. The event highlighted the need for sustainable health emergency preparedness as COVID-19 will not be the world’s last health emergency.

 

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