Milestones :: Perspectives :: Research

Framework for Equitable Allocation of COVID-19 Vaccine
National Academies of Sciences, Engineering, and Medicine
Committee on Equitable Allocation of Vaccine for the Novel Coronavirus; Helene Gayle, William Foege, Lisa Brown, and Benjamin Kahn, Editors
October 2020
PDF: https://download.nap.edu/cart/download.cgi?record_id=25917
Description
In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies and improved therapies.
Health equity is intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of severe illness or death from COVID-19. In the United States and worldwide, the pandemic is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condition, or other contributing factors.
Framework for Equitable Allocation of COVID-19 Vaccine offers an overarching framework for vaccine allocation to assist policy makers in the domestic and global health communities. Built on widely accepted foundational principles and recognizing the distinctive characteristics of COVID-19, this report’s recommendations address the commitments needed to implement equitable allocation policies for COVID-19 vaccine.

Milestones :: Perspectives :: Research

Public consultation for review of draft Considerations for the Assessment of COVID-19 Vaccines for Listing by WHO
Organizations and individuals are invited to review and provide comments/suggestions on the draft Document “Considerations for the assessment of Covid-19 vaccines”

Please provide your comments in writing to WHO no later than 08 October 2020, 18:00 CEST by email at the following address WHOEUL@who.int.

:: CONSIDERATIONS FOR EVALUATION OF COVID19 VACCINES – Points to consider for manufacturers of COVID19 vaccines pdf, 406kb
:: Comments Form doc, 136kb

This document provides advice to manufacturers on both the process and the criteria that will be used by the World Health Organization (WHO) to evaluate COVID-19 vaccines that are submitted either for prequalification (PQ) or for Emergency Use Listing (EUL). The current status of development of a candidate Covid-19 vaccine, the extent of the available quality, safety and efficacy data and regulatory approvals by relevant NRAs will guide WHO’s decision on which pathway (PQ or EUL) to follow for each vaccine.

The submission and review processes are described. Only vaccines that have undergone phase IIb or phase III studies and have received authorization from a reference NRA should be submitted for consideration. Criteria that will be used to assess clinical trial design, endpoints, and statistical criteria are described. Specific data that should be submitted to answer programmatically relevant questions are outlined. Manufacturing, quality control and labelling requirements are summarized, as are non-clinical data to address the potential for vaccine-associated enhanced disease. Post-authorization commitments are specified.

This document should be read in conjunction with the following:
:: “Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies”, WHO Technical Report Series 978, Annex 6, 2013 (1)
:: WHO EUL document (2)
:: “Guidelines on clinical evaluation of vaccines: regulatory expectations”, WHO Technical Report Series 1004, Annex 9, 2017 (3)
:: COVAX SAGE Compendium of Covid-19 vaccine research questions (4)
:: “Guidelines for assuring the quality, safety, and efficacy of plasmid DNA vaccines” adopted by the Seventy-first Meeting of the World Health Organization Expert Committee on Biological Standardization, 24–28August 2020. (5)
:: “Points to Consider for assuring the quality, safety and efficacy of RNA vaccines” (6)
:: “WHO Target Product Profiles for COVID-19 Vaccines” (7)

(1) http://www.who.int/immunization_standards/vaccine_quality/TRS_978_61st_report_Annex_6_PQ_vaccine_procedure.pdf
(2) https://www.who.int/medicines/regulation/prequalification/prequal-vaccines/EUL_PQ_Vaccines/en/
(3) http://www.who.int/biologicals/expert_committee/WHO_TRS_1004_web_Annex_9.pdf
(4) COVAX SAGE Compendium of Covid-19 vaccine research questions
(5) https://www.who.int/publications/m/item/DNA-post-ECBS-1-sept-2020
(6) Currently under development and to be published at https://www.who.int/biologicals
(7) https://www.who.int/publications/m/item/who-target-product-profiles-for-covid-19-vaccines

Milestones :: Perspectives :: Research

Life Science Companies and the Bill & Melinda Gates Foundation: Commitments to Expanded Global Access for COVID-19 Diagnostics, Therapeutics, and Vaccines
Joint Communique 30 September 2020 [Editor’s text bolding]

COVID-19’s existence anywhere poses a threat to communities everywhere. The health, social, and economic impacts can only be addressed through the collective actions of stakeholders across private, public, and philanthropic sectors in partnership with civil society. As organizations dedicated to improving and protecting global health, with our varied skills, roles, and resources, we remain committed to doing our part in ending this pandemic worldwide. Earlier this year AstraZeneca; Bayer; bioMérieux; Boehringer Ingelheim; Bristol Myers Squibb; Eisai; Eli Lilly; Gilead; GSK; Johnson & Johnson; Merck & Co. (known as MSD outside the U.S. and Canada); Merck KGaA, Darmstadt, Germany; Novartis; Pfizer; Roche; and Sanofi together with the Bill & Melinda Gates Foundation each pledged ourselves to the fight against COVID-19.

Collectively, we have launched the most expansive and ambitious pandemic R&D response effort in history, with the promise of a range of interventions that can help end the pandemic. Creating these innovations is not enough, however. Through partnerships with other stakeholders we are committed to ensuring global access to diagnostics, therapeutics, and vaccines that will help to accelerate the end of the pandemic.

To accomplish this critical goal, we will:
:: Develop innovations for patients worldwide. We will continue advancing the research and development of COVID-19 diagnostics, therapeutics, and vaccines that are suitable to meet the needs of populations around the world. To do so, we will work to expand clinical trials to account for diverse representation including lower-income settings and endeavor to address the specific product characteristics needed for use in lower-income settings even after new innovations are brought forward.

:: Strive for timely availability. By scaling up manufacturing at unprecedented speed and much earlier than usual, we will bring large quantities of safe and effective innovations to countries around the world for broad distribution as early as possible, no matter their income level. Mechanisms for rapidly escalating supply must be aligned with the specific context of a rapid pandemic response and tailored to each product, with options including early voluntary licensing and appropriate approaches to peer-to-peer innovator company manufacturing agreements.

:: Enable affordability for lower income countries. We will pursue a range of approaches to make products we are developing or supporting affordable in lower-income countries. These approaches will be independently determined by each supplier in response to the pandemic to address the significant affordability challenges, including approaches such as donations, not-for-profit supply, or equity-based tiered pricing based on countries’ needs and capabilities.

:: Support effective and equitable distribution of these innovations globally. We will strive towards equitable allocation of our products and support global mechanisms like COVAX, recognizing the most effective approach to equitable access will vary across vaccines, therapeutics, and diagnostics. We also will use our collective voice alongside other global health stakeholders to advocate for the strengthening of health systems and distribution networks so crucial innovations reach everyone who needs them. In doing so, we support evidence-based prioritization so that health care workers, high-risk individuals, and other priority groups identified by WHO and other health authorities are protected for the duration of the pandemic, regardless of the country they live in. We will advocate for equitable distribution, recognizing that sovereign nations have final decision-making authority.

:: Maintain public confidence in our innovations. We will continue making the safety of individuals who receive products we are developing or supporting the highest priority. Adherence to the strictest scientific and ethical standards in product development and in manufacturing processes will remain the top priority over speed or politics.

Access to interventions to fight COVID-19 on a global scale requires financial resources, assets, infrastructure, and jurisdictional support and collaboration beyond the capacity or role of the signatories to this commitment. We therefore call on governments, multilateral institutions, companies, NGOs, and others to build on our commitments and efforts already underway to:
:: Provide sufficient, dedicated, sustainable, and timely funding for the procurement and delivery of the tools necessary to end the COVID-19 pandemic.

:: Diversify representation in critical decision-making and coordination bodies with special emphasis on voices representing low-income and lower-middle-income countries.

:: Continue quickly developing and communicating clear guidance on product needs in lower-resource settings as early as possible as our understanding of COVID-19 and the tools to combat it evolve.

:: Advance fit-for-purpose regulatory and liability processes for all stakeholders involved, which prioritize safety while not slowing down access to critical new tools.

:: Build and maintain public confidence in the approval mechanisms for diagnostics, therapeutics, and vaccines by ensuring robust safety and efficacy reviews and removing unwarranted political considerations from these discussions and the approval process.

:: Enhance country readiness and in-country delivery systems by ensuring adequate expertise and resources are in place for effective country planning, distribution, and follow-up for new diagnostics, therapeutics, and vaccines.

The world’s extraordinary situation requires unprecedented collaboration across every part of society. To date, we as life science and philanthropic organizations have risen to this challenge and recognize the need to push further. The commitments above will save lives only if partners across the entire development-to-deployment pathway work together to guarantee products reach the people who need them. The ACT-Accelerator offers a forum for collaboration and action, and the global community must collectively mobilize the resources partners have identified as critical to ending this pandemic for communities everywhere. By aligning those resources with the commitments above, we believe we will not only enable a faster path out of the current COVID-19 crisis but will also lay the foundation for a strong pandemic preparedness ecosystem the next time a pandemic arises.

Pascal Soriot, Executive Director and CEO, AstraZeneca
Stefan Oelrich, Member of the Board of Management, President of Pharmaceuticals, Bayer AG
Bill Gates, Co-Chair and Trustee, Bill & Melinda Gates Foundation
Melinda Gates, Co-Chair and Trustee, Bill & Melinda Gates Foundation
Alexandre Mérieux, Chairman and CEO, bioMérieux
Hubertus von Baumbach, Chairman, Board of Managing Directors, Boehringer Ingelheim GmbH
Giovanni Caforio, Chairman and CEO, Bristol Myers Squibb
Haruo Naito, Representative Corporate Officer and CEO, Eisai Co., Ltd.
David A. Ricks, Chairman and CEO, Eli Lilly and Company
Daniel O’Day Chairman and CEO, Gilead Sciences, Inc.
Emma Walmsley, Chief Executive Officer, GSK
Alex Gorsky, Chairman of the Board and CEO, Johnson & Johnson
Kenneth C. Frazier, Chairman of the Board and CEO, Merck & Co. Inc.
Belén Garijo, Vice Chair of the Executive Board, Deputy CEO, Merck KGaA, Darmstadt, Germany
Vas Narasimhan, M.D., Chief Executive Officer, Novartis
Albert Bourla, DVM, Ph.D., Chairman and CEO, Pfizer Inc.
Dr Severin Schwan, Chief Executive Officer, Roche Group
Paul Hudson, Chief Executive Officer, Sanofi

Milestones :: Perspectives :: Research

Editor’s Note:
In special circumstances, we will include full strategic announcements and statements such as this one:

Pfizer
Moving at the Speed of Science
October 1, 2020
An open letter from Pfizer Chairman and CEO Albert Bourla to U.S. colleagues
[Editor’s text bolding]
Tuesday night I joined the millions of Americans who tuned in to the Presidential debate. Once more, I was disappointed that the prevention for a deadly disease was discussed in political terms rather than scientific facts. People, who are understandably confused, don’t know whom or what to believe. Global health has too much at stake, and the public trust and acceptance of a vaccine is so important to me, that I’m writing to explain the principles we are using at Pfizer today.

Remember from the beginning of the year, it was clear that the suffering and destruction from the COVID-19 pandemic would be extreme. In February, cases began spiraling across the globe. Addressing a pandemic requires many simultaneous fronts of attack, but it became obvious that a safe and effective vaccine could be an essential part of the solution. And, it would take a huge effort by a company with scale to achieve that goal. I knew Pfizer had an obligation to step up and lead.   That is why in March, I declared a bold ambition: that Pfizer would create a vaccine, and we would devote any and all resources necessary to be successful. I further announced, after consulting with our scientists, that we could have vaccine data ready to submit to the FDA by end of the third quarter, in October, and hopefully a hundred million doses delivered by the end of the year. I knew our goal was ambitious, but it would also be critical to protect against the second wave of cases that could accompany the return of colder weather in the Fall.

Since then, and every day for the last seven months, we’ve kept our shoulder to that wheel. Our scientists have leveraged our vaccine research and development expertise, our manufacturing team has innovated to solve production and delivery hurdles, and we’ve recruited more than 35,000 people in clinical trials in multiple countries. Every ounce of our ability has been spent and nearly $2 billion put at risk.

Now, we are approaching our goal and despite not having any political considerations with our pre-announced date, we find ourselves in the crucible of the U.S. Presidential election. In this hyper-partisan year, there are some who would like us to move more quickly and others who argue for delay. Neither of those options are acceptable to me. Against this backdrop, people need to know three things:

First, we are moving at the speed of science. With a virus this ferocious, time is our enemy. This week, we will hit the grim marker of 1 million deaths globally and the number continues to climb. This danger supersedes any other timing considerations.

Second, we would never succumb to political pressure. The only pressure we feel—and it weighs heavy—are the billions of people, millions of businesses and hundreds of government officials that are depending on us. We’ve engaged with many elected leaders around the globe through this health crisis, but Pfizer took no investment money from any government. Our independence is a precious asset.

Third, our priority is the development of a safe and effective vaccine to end this pandemic. I have a duty to Pfizer’s 171-year history to honor our legacy of discovering and manufacturing high-quality medicines. We will never cut a corner. Pfizer’s purpose is simple: “Breakthroughs that Change Patients’ Lives.” It’s our North Star.

Finally, I enjoy a robust policy debate, but I’m not a politician. I’m a scientist, business leader, husband and father, friend and neighbor who cares deeply about the integrity of this potential vaccine. The amplified political rhetoric around vaccine development, timing and political credit is undercutting public confidence. I can’t predict exactly when, or even if our vaccine will be approved by the FDA for distribution to the public. But I do know that the world will be safer if we stop talking about the vaccines’ delivery in political terms and focus instead on a rigorous independent scientific evaluation and a robust independent approval process.   

Let’s continue to work together to build trust in the science. That is what we are doing at Pfizer.  Imagine the compounded tragedy if we have a safe and effective vaccine that many people didn’t trust. That is a risk none of us should accept.

EMERGENCIES

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

Weekly Epidemiological and Operational updates

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Confirmed cases :: 34 495 176 [week ago: 32 429 965]
Confirmed deaths :: 1 025 729 [week ago: 985 823]

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Weekly Epidemiological Update 
Coronavirus disease 2019 (COVID-19)
28 September 2020
Global epidemiological situation
To date, over 32.7 million COVID-19 cases and 991 000 deaths have been reported to WHO. During the week of 21–27 September, there were more than 2 million new cases and 36 000 new deaths reported, which is similar to the numbers reported the previous week. Cumulative deaths are expected to exceed one million in the coming week.

The Region of the Americas continues to carry the highest incidence of COVID-19 globally (Table 1), reporting similar numbers of new cases and deaths as the previous week. The Region accounts for 38% of all new cases and 52% of all new deaths reported in the past seven days. The Eastern Mediterranean Region showed the greatest increase (9%) in cases in the past week, while the European Region reported a substantial rise in deaths, with a 9% increase compared to the previous week. The WHO African, Western Pacific and South-East Asia Regions reported decreases in the new case and deaths over the past week…

Key weekly updates
:: COVID-19: Nearly 33 million cases and one million deaths in 9 months. As Dr Mike Ryan, Executive Director of WHO’s Health Emergencies Programme said at the press conference on Friday 25 September, “the realities of getting a vaccine out there in the next nine months is a big task for everyone involved. There is a lot that can be done to save lives, both in terms of disease control, existing life-saving measures and the innovations that are coming down the pipe. Are we willing to make the investments now that are needed in the ACT Accelerator, especially in COVAX?”

:: A total of 67 higher income economies have joined the COVAX Facility, with another 34 expected to sign, joining 92 low- and middle-income economies eligible for support for the procurement of vaccines. However, so far only a tenth of the $35 billion needed for scale-up and impact have been received, a small investment considering that the global economy is expected to contract by trillions of US dollars this year alone. WHO’s aim is to have two billion doses of vaccine available by the end of 2021.

:: A new report from Every Woman Every Child, “Protect the Progress: Rise, Refocus, Recover, 2020” warns that the COVID-19 crisis is exacerbating existing inequities, with reported disruptions in essential health interventions disproportionately impacting the most vulnerable women and children. “There is no doubt that the pandemic has set back global efforts to improve the health and well-being of women and children, but that should only serve to strengthen our resolve,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

:: WHO has released a video series, Science in 5, in which experts explain the science about specific issues related to COVID-19. So far five episodes have been released on subjects including herd immunity, SARS-CoV2, myths vs science, and reopening schools. Watch these short videos on WHO’s YouTube, Instagram, Facebook, Twitter, and LinkedIn accounts or listen to the podcasts.

:: On 23 September, WHO together with the UN, specialised agencies and partners called on countries to develop and implement action plans to promote the timely dissemination of science-based information and prevent the spread of false information while respecting freedom of expression.

:: WHO has published the Emergency Global Supply Chain System (COVID-19) catalogue, which lists all medical devices, including personal protective equipment, medical equipment, medical consumables, single use devices, laboratory and test-related devices that may be requested through the COVID-19 Supply Portal.

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Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 30 September 2020
:: “The more time you can spend getting your shoes dusty walking and working together in the field, the better you will understand the challenges,” Says Dr Sue Gerber, a Senior Program Officer at the Bill & Melinda Gates Foundation (BMGF) in our latest Women Leaders in Polio Eradication feature.

:: As part of the GPEI’s ongoing research activities to help achieve and sustain polio eradication, in particular to develop Sabin-IPV and polio vaccine-like particle (VLP) development, we have issued a call for nomination of experts to serve on the WHO polio eradication advisory panel on Sabin-IPV and polio VLP vaccine development.

:: On 19 September 2019, a polio outbreak was declared in the Philippines after a 3-year-old child and several environmental samples tested positive for polioviruses. Fifteen other children have been paralyzed by polio since the outbreak started. To protect children from lifelong paralysis due to polio, vaccination rounds have been conducted in parts of the country. Meet the #HeroesEndingPolio who have been working to combat polio in the Philippines.

Summary of new WPV and cVDPV viruses this week (AFP cases and environmental samples):
:: Afghanistan: two WPV1 positive environmental samples
:: Pakistan: one WPV1 case, 9 WPV1 positive environmental samples, three cVDPV2 cases and two cVDPV2 positive environmental samples
:: Cameroon: one cVDPV2 case and one cVDPV2 positive environmental sample
:: Democratic Republic of the Congo (DR Congo): six cVDPV2 cases
:: Guinea: seven cVDPV2 cases
:: Sudan: one cVDPV2 case and five cVDPV2 positive environmental samples

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WHO Grade 3 Emergencies [to 3 Oct 2020]

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

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WHO Grade 2 Emergencies [to 3 Oct 2020]
Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burkina Faso [in French] – No new digest announcements identified
Burundi – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Ethiopia – No new digest announcements identified
Iran floods 2019 – No new digest announcements identified
Iraq – No new digest announcements identified
Libya – No new digest announcements identified
Malawi Floods – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Mozambique – No new digest announcements identified
Myanmar – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

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WHO Grade 1 Emergencies [to 3 Oct 2020]

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

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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: Syrian Arab Republic: COVID-19 Humanitarian Update No. 19 As of 29 September 2020

Yemen
– No new digest announcements identified

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UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
COVID-19
:: Coronavirus disease 2019 (COVID-19) Situation Report 46: occupied Palestinian territory, issued 1 October 2020, information for period: 5 March – 1 October 2020

East Africa Locust Infestation
::  Desert Locust situation update – 29 September 2020

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WHO & Regional Offices [to 3 Oct 2020]

The best time to prevent the next pandemic is now: countries join voices for better emergency preparedness
1 October 2020
News release
COVID-19 will not be the world’s last health emergency and there is an urgent need for sustainable health emergency preparedness to deal with the next one.
This was the strong sentiment shared by participants of the United Nations General Assembly side-event on ‘Sustainable preparedness for health security and resilience: Adopting a whole-of-society approach and breaking the “panic-then-forget” cycle’. The high-level virtual event was co-hosted by Finland, France and Indonesia, along with the World Health Organization (WHO)…

Global partnership to make available 120 million affordable, quality COVID-19 rapid tests for low- and middle-income countries
28 September 2020
News release
:: A full access package includes WHO policy guidance on the use of antigen-based rapid diagnostic tests, manufacturer volume guarantees for low and middle-income countries, catalytic funding to assist governments to deploy the tests and an initial US$50 million procurement fund
:: Several rapid, point-of-care antigen tests are being assessed by WHO for Emergency Use Listing (EUL)
:: Agreements between the Bill & Melinda Gates Foundation and test manufacturers Abbott and SD Biosensor make available innovative tests priced at a maximum of US$5 for low- and middle-income countries (LMICs)
:: The Global Fund commits an initial US$50 million to enable countries to purchase the new tests, with the first orders expected to be placed this week
:: Expedited market introduction of these tests in multiple LMICs is being supported through the Africa Centres for Disease Control and Prevention (Africa CDC), Unitaid, FIND, CHAI, and their partners
:: This is the latest move from the Access to COVID-19 Tools (ACT) Accelerator to develop, procure and distribute critical new tools to fight the pandemic; new tests are urgently needed to meet the huge unmet needs for testing worldwide

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Weekly Epidemiological Record, 2 October 2020, vol. 95, 40 (pp. 477–488)
Maternal and neonatal tetanus eliminated in the south-west geopolitical zone of Nigeria
Progress in eliminating onchocerciasis in the WHO Region of the Americas: advances towards transmission suppression in parts of the Yanomami focus area.

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Review of maternal deaths and the continuity of essential reproductive, maternal, an…
01 October 2020
In the context of the double burden of COVID-19 and Humanitarian Emergencies in the Sahel region, analysis of data from the official weekly telegram-letter (TLOH) of the Ministry of Health’s showed an unusually high number of institutional maternal deaths reported in this region during the four weeks (Week 16 to Week 19) of the year 2020, compared to data from the same period in 2019.
:: Statement from Dr Matshidiso Moeti, WHO Regional Director for Africa, on Sexual Abus…
30 September 2020
Brazzaville – The allegations of sexual exploitation and abuse by aid workers, who identified themselves as working for the World Health Organization (WHO) Ebola response in the Democratic Republic of the Congo are deeply horrific and heartbreaking. All my life as a woman, doctor, leader, mother and health worker, I have fought against gender inequality, as well as sexual harassment and abuse. When I became WHO Regional Director for Africa, I committed to advancing women’s careers and interests in the workplace and robustly addressing sexual harassment.
:: African island states launch joint medicines procurement initiative
29 September 2020
Ministers of Health from seven small African island states today signed an agreement to jointly procure drugs and vaccines in a bid to improve quality and access to medicines and other health products.

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
No new digest content identified

WHO European Region EURO
:: WHO and European Union support COVID-19 training for medical personnel in Georgia to improve health system readiness 30-09-2020
:: Global solidarity in the fight against COVID-19 takes centre stage during Regional Director’s visit to Russian Federation 30-09-2020
:: Tobacco use and exposure to second-hand smoke linked to more than 20% of deaths from coronary heart disease 29-09-2020

WHO Eastern Mediterranean Region EMRO
:: WHO Regional Director’s press briefing statement on vaccine development and COVAX Facility for COVID-19 30 September 2020

WHO Western Pacific Region
No new digest content identified

Africa CDC [to 3 Oct 2020]
http://www.africacdc.org/
News
Press Releases
Trade and Development Bank donates half a million dollars to COVID-19 response in Africa
30 September 2020

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

National Health Commission of the People’s Republic of China
http://en.nhc.gov.cn/
News
Oct 3: Daily briefing on novel coronavirus cases in China
On Oct 2, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 10 new cases of confirmed infections.

Central authority inspects local COVID-19 prevention
2020-09-30
China’s central authority has sent inspection teams to multiple regions in the country in a supervision campaign to check COVID-19 containment measures and make sure these localities are ready to prevent a resurgence of infections in autumn and winter…

Macao SAR gov’t to buy 1.4 mln COVID-19 vaccines for all residents
2020-09-29
The Macao Special Administrative Region (SAR) government will buy 1.4 million doses of novel coronavirus (COVID-19) vaccines for all Macao residents, the SAR’s COVID-19 response center said here on Sept 28.
The Novel Coronavirus Response and Coordination Center of the Macao SAR told the press that the vaccines will be sent to Macao in different batches, and certain groups such as senior residents, patients with chronic diseases and people working in anti-pandemic frontlines will get vaccinated with priority.
The first batch of COVID-19 vaccines is enough to cover all those priority groups, whose number is estimated at 150,000, the response center added…

China reports good results on 11 vaccine candidates
2020-09-28
… A senior official with the Chinese Ministry of Science and Technology, Wu Yuanbin, said on Sept 25 China has registered good results on the safety and efficiency of vaccines in the phase one and two clinical trials. He added that China is among the countries leading in COVID-19 vaccine research and development.
“Eleven vaccine candidates are under clinical trial, and four of them are in phase three trials. Chinese companies are working with related organizations in other countries, including those in the Middle East, South America, and Southeast Asia.”
The ministry says the trials are going well, but it’s still uncertain when the vaccines will be in the market. It has also outlined how the vaccines will be distributed when ready….

Expert: Large-scale vaccination will take 1-2 years
2020-09-27
It will need at least one or two years for mass vaccination to prevent COVID-19, Zhong Nanshan, a leading respiratory disease expert, said on Sept 24, and he called on people to take conventional measures to prevent the disease at present…

Announcements

Paul G. Allen Frontiers Group [to 3 Oct 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

BARDA – U.S. Department of HHS [to 3 Oct 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
September 30, 2020: Two novel investigational drugs targeting antibiotic-resistant infections move into advanced development with HHS
:: One drug candidate may restore the body’s natural balance of bacteria to prevent Clostridioides difficile (C. difficile) infections, a serious complication of certain antibiotics or long-term antibiotic use
:: Second drug candidate uses CRISPR technology, carried in a virus, to kill Escherichia coli (E. coli) bacteria that cause recurring or drug-resistant urinary tract infections (UTIs)
… BARDA will provide an initial $7.36 million and up to a total of $76.9 million over nine-and-a-half years to Vedanta Biosciences, Inc., of Cambridge, Massachusetts, to support development of VE303 to prevent C. difficile infections. BARDA also will provide an initial $11 million and up to a total of $77 million over five years to Locus Biosciences of Morrisville, North Carolina, part of a $144 million program to develop LBP-EC01 to treat recurrent UTIs including those caused by antibiotic-resistant E. coli…

BMGF – Gates Foundation [to 3 Oct 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
SEPTEMBER 30, 2020
Life Science Companies and the Bill & Melinda Gates Foundation: Commitments to Expanded Global Access for COVID-19 Diagnostics, Therapeutics, and Vaccines
30 September 2020
[See Milestones above for detail]

SEPTEMBER 29, 2020
Statement from CEO Mark Suzman on Momentum in Global COVID-19 Response
SEATTLE, September 29, 2020 – The death toll from COVID-19 passed one million this week. It is a sobering moment. But there is cause for optimism as recent days have seen a significant surge in momentum around global cooperation, which is our greatest strength when it comes to consigning this pandemic to the history books.

Bill & Melinda Gates Medical Research Institute [to 3 Oct 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

CARB-X [to 3 Oct 2020]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
No new digest content identified.

CEPI – Coalition for Epidemic Preparedness Innovations [to 3 Oct 2020]
http://cepi.net/
Latest News
Why and how do we harmonise assessment of COVID-19 vaccine trials?
Valentina Bernasconi, Preclinical and Immunology Scientist at CEPI and Project Leader of the Centralised Laboratory Network, discusses the importance of centralising the analysis of samples obtained…
02 Oct 2020

CEPI establishes global network of laboratories to centralise assessment of COVID-19 vaccine candidates
All COVID-19 vaccine developers can use the network of five laboratories working together as part of centralised network to reliably assess and compare immunological responses generated by COVID-19…
02 Oct 2020

Why we need a “portfolio approach” to COVID-19 vaccine development
Hundreds of vaccine candidates against COVID-19 are under development. Predicting which of these will be successful is extremely difficult. That’s why we need multiple shots at goal, writes Nick…
28 Sep 2020

EDCTP [to 3 Oct 2020]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
No new digest content identified.

Emory Vaccine Center [to 3 Oct 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Medicines Agency [to 3 Oct 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September – 1 October 2020
PRAC, Last updated: 02/10/2020
EMA’s safety committee (PRAC) has started a review of a safety signal to assess reports of acute  kidney injury in some patients with COVID-19 taking Veklury (remdesivir).
Veklury has been given a ‘conditional marketing authorisation’ in the EU for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen, because the benefits to these severely ill patients outweigh the risks of making the medicine available despite having less complete data than normally expected. This means that more evidence is required to be submitted in the post-authorisation phase…

News: EMA starts first rolling review of a COVID-19 vaccine in the EU
Last updated: 01/10/2020
EMA’s human medicines committee (CHMP) has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by the company AstraZeneca in collaboration with the University of Oxford.
The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data). This does not mean that a conclusion can be reached yet on the vaccine’s safety and effectiveness, as much of the evidence is still to be submitted to the committee.
A rolling review is one of the regulatory tools that the Agency uses to speed up the assessment of a promising medicine or vaccine during a public health emergency…

European Vaccine Initiative [to 3 Oct 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

FDA [to 3 Oct 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
October 2, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 2, 2020
:: The FDA posted a transcript of Dr. Stephen M. Hahn, M.D.’s remarks to the National Consumers League earlier this week about the vaccine review process.

October 1, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 1, 2020
:: Today, the FDA revised its Emergency Use Authorization (EUA) to reflect changes in the distribution and allocation of the antiviral drug Veklury (remdesivir). More information about the revised EUA can be found here.

September 30, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 30, 2020
:: Today, the U.S. Food and Drug Administration (FDA) updated the SARS CoV-2 reference panel comparative data on FDA’s website to reflect the latest information.
:: The FDA also posted an infographic that provides a visualization of data associated with CDRH’s response to the coronavirus (COVID-19) pandemic.

Fondation Merieux [to 3 Oct 2020]
http://www.fondation-merieux.org/
News, Events
Event
Let’s take a look back on the ACDx webinar on the critical role of diagnostics in the COVID-19 pandemic
October 1, 2020, Virtual
What is the role of diagnostics in the management of the COVID-19 sanitary crisis around the world? What are the …

Project
Fight against COVID-19: supporting the Akamasoa association and OSCAPE in Madagascar
September 29, 2020, Antananarivo (Madagascar)
The Mérieux Foundation in Madagascar acts alongside two partner organizations – the Akamasoa association and OSCAPE – to fight against …

Gavi [to 3 Oct 2020]
https://www.gavi.org/
News releases
1 October 2020
Gavi to provide US$ 150 million to support low- and middle-income countries’ readiness to deliver COVID-19 vaccines
:: The Gavi Board has approved the provision of US$ 150 million in initial funding to jumpstart support COVAX AMC-eligible countries’ readiness to deliver COVID-19 vaccines, in the form of planning, technical assistance and cold chain equipment
:: The Board also provisionally approved new governance structures for the COVAX Facility that aim to ensure a voice for all economies and partners engaged in the effort to ensure global, equitable access to safe and effective COVID-19 vaccines
…The Board gave approval for the provisional establishment of governance bodies that will involve all 168 self-financing and AMC-eligible economies engaged in the COVAX Facility. The 76 self-financing economies will form part of the COVAX Shareholders Council, while the 92 economies eligible for the COVAX AMC will form part of the AMC Engagement Group. Both groups will serve a non-technical strategic and advisory function with respect to operational aspects of COVAX Facility implementation, and will be self-organising…

29 September 2020
New collaboration makes further 100 million doses of COVID-19 vaccine available to low- and middle-income countries
:: Collaboration among the Serum Institute of India (SII), Gavi, the Vaccine Alliance and the Bill & Melinda Gates Foundation will accelerate manufacturing and delivery of up to an additional 100 million doses of future vaccines, if proven to be safe and effective, for low- and middle-income countries in 2021
:: The expansion follows August’s announcement of up to 100 million doses to be delivered by the collaboration, bringing the total now to be delivered by the partnership to up to 200 million doses of COVID-19 vaccines, priced at a maximum of US$ 3 per dose, with an option to secure more
:: Dr Seth Berkley: “This is vaccine manufacturing for the Global South, by the Global South, helping us to ensure no country is left behind when it comes to the race for a COVID-19 vaccine”

29 September 2020
José Manuel Barroso named as new Chair of the Gavi Board
:: Gavi Board unanimously approves the selection of former Prime Minister of Portugal and President of the European Commission José Manuel Barroso as its new Chair
:: Barroso will replace Dr Ngozi Okonjo-Iweala, whose term ends in December 2020.
:: Barroso: “The world needs Gavi now more than ever, both to ensure COVID-19 vaccines reach every country, rich and poor, and to press ahead with its core mission to protect hundreds of millions of people from preventable diseases.”

GHIT Fund [to 3 Oct 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that September 29, 2020
GHIT Fund Announces New Investments: A Total of 1.37 Billion Yen in Drugs for Malaria, Chagas Disease, Leishmaniasis, Schistosomiasis, and Soil-Transmitted Helminths, and Diagnostics for Malaria, Buruli Ulcer, and Schistosomiasis

Global Fund [to 3 Oct 2020]
https://www.theglobalfund.org/en/news/
News/Updates
Global partnership to make available 120 million affordable, quality COVID-19 rapid tests for low- and middle-income countries
28 September 2020
A set of agreements to make available, for low and middle-income countries, affordable, high-quality COVID-19 antigen rapid tests were today announced by the Access to COVID-19 Tools (ACT) Accelerator.

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 3 Oct 2020]
https://www.glopid-r.org/news/
News
No new digest content identified.

Hilleman Laboratories [to 3 Oct 2020]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 3 Oct 2020]
http://www.humanvaccinesproject.org/media/press-releases/
HVP COVID Report
No More Silos – Global Collaboration Should Drive Vaccine Development
October 1, 2020

IAVI [to 3 Oct 2020]
https://www.iavi.org/newsroom
No new digest content identified.

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

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
No new digest content identified.

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

IFRC [to 3 Oct 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Guatemala, Honduras
Hundreds receive aid as migrants cross into Guatemala
Geneva/Panama, 2 October 2020 – The Guatemalan and Honduran Red Cross Societies are providing assistance and care to hundreds of migrants who have crossed the border from Honduras to Guatemala. In Guatemala, Red Cross volunteers have been deployed to E …
2 October 2020

Global
“A million individual tragedies” – IFRC statement as official COVID-19 death toll hits 1 million
Geneva, 28 September 2020 – The following is attributable to Jagan Chapagain, Secretary General of the International Federation of Red Cross and Red Crescent Societies (IFRC): “Today, we stand in grim solidarity with the hundreds of thousands of famili …
28 September 2020

Indonesia
Two years after tsunami, communities tackle COVID-19 crisis
Palu/Jakarta/Kuala Lumpur, 28 September 2020 – Two years after an earthquake and tsunami struck communities in Central Sulawesi, Indonesia, thousands of survivors face a severe socio-economic crisis caused by the COVID-19 pandemic. The September 28 ear …
28 September 2020

IRC International Rescue Committee [to 3 Oct 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
IRC launches response to Ebola outbreak in DRC as new assessment finds massive need amidst COVID pandemic
September 30, 2020

Press Release
New report reveals how the failures of the international community to combat COVID-19 has led to dire consequences for millions of the most vulnerable
September 29, 2020

IVAC [to 3 Oct 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

IVI [to 3 Oct 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
Event
Building Vaccine Diplomacy and Advocacy
IVI Virtual State Forum 2020
Tuesday, October 13, 2020
04:00 New York / 10:00 Geneva, Copenhagen, Oslo / 17:00 Seoul
Watch live: bit.ly/ivi-state-forum-2020
Registration Required

JEE Alliance [to 3 Oct 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

MSF/Médecins Sans Frontières [to 3 Oct 2020]
http://www.msf.org/
Latest [Selected Announcements]
Greece
European policies of deterrence and containment degrade human life
Op-Ed 1 Oct 2020

South Sudan
Young biotechnologists at the forefront of the COVID-19 response
Project Update 1 Oct 2020

Women’s health
Proposed changes to US Global Gag Rule threaten wider harm to women
Interview 28 Sep 2020

National Vaccine Program Office – U.S. HHS [to 3 Oct 2020]
https://www.hhs.gov/vaccines/about/index.html
No new digest content identified.

NIH [to 3 Oct 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH to assess and expand COVID-19 testing for underserved communities
September 30, 2020 — RADx-UP program will support projects designed to rapidly implement testing strategies.
The National Institutes of Health has awarded nearly $234 million to improve COVID-19 testing for underserved and vulnerable populations. A part of the Rapid Acceleration of Diagnostics (RADx) initiative, the RADx Underserved Populations (RADx-UP) program will support 32 institutions across the United States and will focus on populations disproportionately affected by the pandemic. These groups include African Americans, American Indians/Alaskan Natives, Latinos/Latinas, Native Hawaiians, older adults, pregnant women and those who are homeless or incarcerated…

Investigational COVID-19 vaccine well-tolerated and generates immune response in older adults
September 29, 2020 — A Phase 1 clinical trial enrolled 40 healthy volunteers.
A Phase 1 trial of an investigational mRNA vaccine to prevent SARS-CoV-2 infection has shown that the vaccine is well-tolerated and generates a strong immune response in older adults. A report published today in the New England Journal of Medicine describes the findings from the study, which was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. SARS-CoV-2 is the virus that causes COVID-19 disease.
Anderson et al. Safety and immunogenicity of SARS-CoV-2 mRNA-1273 vaccine in older adults. New England Journal of Medicine DOI: 10.1056/NEJMoa2028436 (2020).

PATH [to 3 Oct 2020]
https://www.path.org/media-center/
Press Releases
PATH applauds passage of critical COVID-19 emergency funding legislation in U.S. House of Representatives
October 1, 2020 by PATH
The newly updated HEROES Act not only proposes support for COVID-19 pandemic response in the United States, but also adds critical emergency funding for global health programs.

PATH receives grant to combat soil-transmitted helminth infections
September 30, 2020 by PATH
A grant from the GHIT Fund will support partners in the United States and Japan to develop a new low-cost, broad spectrum anthelmintic protein Cry5B oral treatment option.

Sabin Vaccine Institute [to 3 Oct 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

UNAIDS [to 3 Oct 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
1 October 2020
Young people discuss innovations to reduce health inequalities

30 September 2020
“I want to contribute to creating a world without stigma and discrimination”: young women living with HIV in Uzbekistan become activists

28 September 2020
New HIV infections increasingly among key populations

UNICEF [to 3 Oct 2020]
https://www.unicef.org/media/press-releases
Statement
10/02/2020
Remarks by Henrietta Fore, UNICEF Executive Director, at press briefing on Education Plus initiative
As prepared for delivery

Statement
10/02/2020
Remarks by Henrietta Fore, UNICEF Executive Director, at Security Council meeting on universal connectivity & access to digital technology in conflict & post-conflict contexts
As prepared for delivery

Statement
09/30/2020
UNICEF statement on allegations of sexual exploitation and abuse in the Democratic Republic of the Congo

Press release
09/30/2020
UN agencies hail milestone as over 1000 asylum seekers relocated from Greece so far this year through EU initiative

Statement
09/30/2020
Statement by Henrietta H. Fore, UNICEF Executive Director at the high-level side event on the ACT-Accelerator at the 75th session of UN General Assembly

Statement
09/29/2020
UNICEF condemns the death of four children in Baghdad and calls on all parties to protect children from violence
Statement attributable to Ms Hamida Lasseko, UNICEF Representative in Iraq

Statement
09/29/2020
Statement by UNICEF Executive Director Henrietta Fore on 30th anniversary of World Summit for Children

Unitaid [to 3 Oct 2020]
https://unitaid.org/
Featured News
No new digest content identified.

Vaccination Acceptance Research Network (VARN) [to 3 Oct 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

Vaccine Confidence Project [to 3 Oct 2020]
http://www.vaccineconfidence.org/
Research and Reports
The Harris Poll: Nearly 80% of Americans think that the speedy approval process of a coronavirus vaccine is driven by politics – NOT by proof that shots work
1 Oct 2020

Vaccine Education Center – Children’s Hospital of Philadelphia [to 3 Oct 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

Wellcome Trust [to 3 Oct 2020]
https://wellcome.ac.uk/news
Opinion | 28 September 2020
Covid-19 in the UK: the hard choices we face
Jeremy Farrar, Director Wellcome
Six months after lockdown was first announced in the UK, the country is seeing a rise in Covid-19 infections. Jeremy Farrar reflects on the measures we need to take to suppress transmission.

The Wistar Institute [to 3 Oct 2020]
https://www.wistar.org/news/press-releases
Press Releases
Sep. 30, 2020
New Mechanism of Cell Survival in Chronic Lymphocytic Leukemia
Role of STING signaling in normal B cell differentiation suggests that reduced STING expression and activation promotes malignant cell survival through increased B cell receptor signaling.

WFPHA: World Federation of Public Health Associations [to 3 Oct 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.

World Organisation for Animal Health (OIE) [to 3 Oct 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

::::::

ARM [Alliance for Regenerative Medicine] [to 3 Oct 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.

BIO [to 3 Oct 2020]
https://www.bio.org/press-releases
Press Releases
BIO’s Dr. McMurry-Heath Calls on HHS Sec. Azar to Publicly Release FDA Guidance on Emergency Use Authorization for Covid-19 Vaccines
October 1, 2020

The Honorable Alex Azar
Secretary of U.S. Department of Health & Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Dear Secretary Azar:
On behalf of the scientists and researchers the Biotechnology Innovation Organization (BIO) represents, I am writing to request that you publicly release all new guidance developed by the Food and Drug Administration (FDA) concerning emergency use authorization for vaccines to prevent the spread of COVID-19. The release of FDA guidance would provide scientists and researchers greater regulatory clarity and strengthen public confidence in any future vaccine that may be authorized or approved.

BIO member companies are leading a global effort to develop vaccines against COVID-19. In fact, more than 180 experimental vaccines for COVID-19 are currently in development, including 10 that now are in Phase 3 clinical trials. The scale and speed of the biopharmaceutical industry’s response to the novel coronavirus are unprecedented. These efforts to bring a safe and effective vaccine to the public provide real hope that this pandemic will soon end, and our nation will begin to return to normal.

Our organization and member companies are working closely with FDA scientists and public health experts to achieve our shared commitment to testing and developing vaccines in strict accordance with sound scientific principles and with high ethical and safety standards.

That is why we were encouraged to learn the FDA has been finalizing new guidance to clarify what biopharmaceutical companies will need to demonstrate for safety and efficacy data in order to receive emergency use authorization for COVID-19 vaccines. Insight into FDA’s views on clinical and scientific factors underlying emergency use authorization of COVID-19 vaccines would support ongoing research and development.

All new FDA guidance should be finalized and communicated with those on the frontlines developing potential vaccines. Just as importantly, it must also be shared more broadly with the American public. We cannot allow a lack of transparency to undermine confidence in the vaccine development process. The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic. Releasing any additional guidance on granting emergency use authorization for a vaccine will go a long way in accomplishing this critical goal.

On behalf of BIO and its members, I am deeply grateful for the efforts of countless individuals across the federal government in response to this public health crisis. We look forward to continuing to work with key government partners to achieve our shared goal of ending the COVID-19 pandemic quickly and safely.

Best,
Dr. Michelle McMurry-Heath, Ph.D.
President and CEO

DCVMN – Developing Country Vaccine Manufacturers Network [to 3 Oct 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

ICBA – International Council of Biotechnology Associations [to 3 Oct 2020]
https://internationalbiotech.org/
News
No new digest content identified.

IFPMA [to 3 Oct 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

PhRMA [to 3 Oct 2020]
http://www.phrma.org/
Selected Press Releases, Statements
No new digest content identified.

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

American Journal of Infection Control
October 2020 Volume 48, Issue 10, p1133-1286
http://www.ajicjournal.org/current

Major Articles
Mandatory employee vaccination as a strategy for early and comprehensive health care personnel immunization coverage: Experience from 10 influenza seasons
Christopher Blank, Nancy Gemeinhart, W. Claiborne Dunagan, Hilary M. Babcock
p1133–1138
Published online: March 29, 2020

American Journal of Preventive Medicine
October 2020 Volume 59, Issue 4, p469-620
http://www.ajpmonline.org/current

Research Articles
Vaccine Efficacy Needed for a COVID-19 Coronavirus Vaccine to Prevent or Stop an Epidemic as the Sole Intervention
Sarah M. Bartsch, Kelly J. O’Shea, Marie C. Ferguson, Maria Elena Bottazzi, Patrick T. Wedlock, Ulrich Strych, James A. McKinnell, Sheryl S. Siegmund, Sarah N. Cox, Peter J. Hotez, Bruce Y. Lee
p493–503
Published online: July 15, 2020
This study found that the vaccine has to have an efficacy of at least 70% to prevent an epidemic and of at least 80% to largely extinguish an epidemic without any other measures (e.g., social distancing).

American Journal of Public Health
October 2020 110(S3) Supplement 3 2020
http://ajph.aphapublications.org/toc/ajph/current

Health Misinformation on Social Media
This special supplement issue features research and perspectives on the dangers—and opportunities—posed by a shift in how modern populations consume health information via social media. Just as the spread of misinformation by malicious and unwitting parties poses a threat to public health and the credibility of institutional knowledge, so too do these platforms offer new approaches to counteract rumors and intentional deception in real time and with targeted strategies.

American Journal of Public Health
October 2020 110(S3) Supplement 3 2020
http://ajph.aphapublications.org/toc/ajph/current

A Prologue to the Special Issue: Health Misinformation on Social Media
Wen-Ying Sylvia Chou PhD, MPH, and Anna Gaysynsky MPHAuthor affiliations, information, and correspondence details
Accepted: August 20, 2020
Published Online: October 01, 2020

American Journal of Tropical Medicine and Hygiene
Volume 103, Issue 3, September 2020
http://www.ajtmh.org/content/journals/14761645/103/3

Editorial
Keep Politics out of Funding Decisions for Medical Research and Public Health
Philip J. Rosenthal, Daniel G. Bausch, Karen A. Goraleski, David R. Hill, Julie A. Jacobson, Chandy C. John and Joel G. Breman
Pages: 931–932
https://doi.org/10.4269/ajtmh.20-0850

American Journal of Tropical Medicine and Hygiene
Volume 103, Issue 3, September 2020
http://www.ajtmh.org/content/journals/14761645/103/3

Perspective Piece
The Equatoguinean Malaria Vaccine Initiative: From the Launching of a Clinical Research Platform to Malaria Elimination Planning in Central West Africa
Peter F. Billingsley, Carl D. Maas, Ally Olotu, Christopher Schwabe, Guillermo A. García, Matilde Riloha Rivas, Dianna E. B. Hergott, Claudia Daubenberger, Elizabeth Saverino, Adel Chaouch, Oscar Embon, Mwajuma Chemba, Elizabeth Nyakarungu, Ali Hamad, Carlos Cortes, Tobias Schindler, Maximillian Mpina, Ali Mtoro, B. Kim Lee Sim, Thomas L. Richie, Ken McGhee, Marcel Tanner, Gabriel Mbaga Obiang Lima, Salim Abdulla, Stephen L. Hoffman and Mitoha Ondo’o Ayekaba

Pages: 947–954
https://doi.org/10.4269/ajtmh.19-0966

American Journal of Tropical Medicine and Hygiene
Volume 103, Issue 3, September 2020
http://www.ajtmh.org/content/journals/14761645/103/3

Review Article
Global Governing Bodies: A Pathway for Gene Drive Governance for Vector Mosquito Control
Adam Kelsey, Drusilla Stillinger, Thai Binh Pham, Jazmin Murphy, Sean Firth and Rebeca Carballar-Lejarazú
Pages: 976–985
https://doi.org/10.4269/ajtmh.19-0941

American Journal of Tropical Medicine and Hygiene
Volume 103, Issue 3, September 2020
http://www.ajtmh.org/content/journals/14761645/103/3

Perspective Piece
The Equatoguinean Malaria Vaccine Initiative: From the Launching of a Clinical Research Platform to Malaria Elimination Planning in Central West Africa
Peter F. Billingsley, Carl D. Maas, Ally Olotu, Christopher Schwabe, Guillermo A. García, Matilde Riloha Rivas, Dianna E. B. Hergott, Claudia Daubenberger, Elizabeth Saverino, Adel Chaouch, Oscar Embon, Mwajuma Chemba, Elizabeth Nyakarungu, Ali Hamad, Carlos Cortes, Tobias Schindler, Maximillian Mpina, Ali Mtoro, B. Kim Lee Sim, Thomas L. Richie, Ken McGhee, Marcel Tanner, Gabriel Mbaga Obiang Lima, Salim Abdulla, Stephen L. Hoffman and Mitoha Ondo’o Ayekaba

Artificial Intelligence – An International Journal
Volume 288 November 2020
https://www.sciencedirect.com/journal/artificial-intelligence/vol/288/suppl/C

Research article Abstract only
Combining experts’ causal judgments
Dalal Alrajeh, Hana Chockler, Joseph Y. Halpern
Article 103355
Abstract
Consider a policymaker who wants to decide which intervention to perform in order to change a currently undesirable situation. The policymaker has at her disposal a team of experts, each with their own understanding of the causal dependencies between different factors contributing to the outcome. The policymaker has varying degrees of confidence in the experts’ opinions. She wants to combine their opinions in order to decide on the most effective intervention. We formally define the notion of an effective intervention, and then consider how experts’ causal judgments can be combined in order to determine the most effective intervention. We define a notion of two causal models being compatible, and show how compatible causal models can be merged. We then use it as the basis for combining experts’ causal judgments. We also provide a definition of decomposition for causal models to cater for cases when models are incompatible. We illustrate our approach on a number of real-life example

BMJ Global Health
October 2020 – Volume 5 – 10
https://gh.bmj.com/content/5/10

Commentary
Symptoms of a broken system: the gender gaps in COVID-19 decision-making
(1 October, 2020)
Kim Robin van Daalen, Csongor Bajnoczki, Maisoon Chowdhury, Sara Dada, Parnian Khorsand, Anna Socha, Arush Lal, Laura Jung, Lujain Alqodmani, Irene Torres, Samiratou Ouedraogo, Amina Jama Mahmud, Roopa Dhatt, Alexandra Phelan, Dheepa Rajan

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 3 Oct 2020)

Determinants of self-paid rotavirus vaccination status in Kanazawa, Japan, including socioeconomic factors, parents’ perception, and children’s characteristics
Japan’s National Immunization Program does not cover rotavirus vaccine and no government subsidies are available. This study aimed to measure the uptake of and determinants that influenced self-paid rotavirus …
Authors: Megumi Hara, Rie Koshida, Kaoru Araki, Masahide Kondo and Yoshio Hirota
Citation: BMC Infectious Diseases 2020 20:712
Content type: Research article
Published on: 29 September 2020

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 3 Oct 2020)

Researchers’ views on, and experiences with, the requirement to obtain informed consent in research involving human participants: a qualitative study
Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent.
Authors: Antonia Xu, Melissa Therese Baysari, Sophie Lena Stocker, Liang Joo Leow, Richard Osborne Day and Jane Ellen Carland
Content type: Research article
2 October 2020

Bulletin of the World Health Organization
Volume 98, Number 10, October 2020, 645-724
https://www.who.int/bulletin/volumes/98/10/en/

EDITORIALS
COVID-19 and sustainable development goals
— Kristin Heggen, Tony J Sandset & Eivind Engebretsen
http://dx.doi.org/10.2471/BLT.20.263533

Clinical Pharmacology & Therapeutics
Volume 108, Issue 4 Pages: 681-895 October 2020
https://ascpt.onlinelibrary.wiley.com/toc/15326535/current

Perspectives
Pandemic Best Regulatory Practices: An Urgent Need in the COVID‐19 Pandemic
Murray M. Lumpkin, John C. W. Lim
Pages: 703-705
First Published:04 June 2020
Abstract
As large numbers of candidate drugs and vaccines for potential use in the coronavirus disease 2019 (COVID‐19) pandemic are being investigated, medicine regulators globally must now make urgent, informed, contextually risk‐1based decisions regarding clinical trials and marketing authorizations. They must do this with the flexibility demanded by the pandemic while maintaining their core risk assessment and public safety functions. We lay out the critical role of regulators in the current crisis and offer eight “pandemic best regulatory practices.” These should support both the regulatory public heath imperative and assure timely patient access to effective, safe, quality products worldwide during this emergency—thus contributing to ending this pandemic as quickly, effectively, and safely as possible.

Clinical Pharmacology & Therapeutics
Volume 108, Issue 4 Pages: 681-895 October 2020
https://ascpt.onlinelibrary.wiley.com/toc/15326535/current

Mini‐Review Open Access
Leading a Digital Transformation in the Pharmaceutical Industry: Reimagining the Way We Work in Global Drug Development
Luca A. Finelli, Vas Narasimhan
Pages: 756-761
First Published:15 April 2020
Abstract
We are experiencing seminal times in computing that seem to define a fourth industrial revolution. This may fundamentally change the way we live, work, and relate to one another. Embracing data and digital information is a top priority for most industries these days, and Life Sciences is no exception. The pharmaceutical industry in particular is fundamentally a data‐driven business. Inspired by a desire to “Go Big on Data,” we developed a strategic roadmap defining a digital transformation to reimagine the way we work in Novartis Global Drug Development, leveraging data science to generate and inject actionable insights into our best practices. We launched a program called Nerve Live, and built a state‐of‐the‐art data and analytics platform to harness past and present operational data, providing access to decades of drug development “experience” buried across multiple sources. The platform enabled the systematic application of machine learning and predictive analytics to generate “intelligence”: new insights across multiple functional areas. To action the insights and create “value,” we crafted skillfully designed end‐user applications for domain experts to plan, track, predict, compare and monitor domain activities, optimize costs, and maximize quality. Today, the Nerve Live program enables insights‐driven decision making at scale, unlocking productivity, and providing transparency across the Novartis Global Drug Development organization and beyond. We identified three main drivers making the Nerve Live program successful and enabling the associated digital transformation to flourish. We discuss the challenges, highlight the benefits, and see the importance of leading the way to become future proof.

Clinical Therapeutics
August 2020 Volume 42, Issue 8, p1425-1624, e115-e160
http://www.clinicaltherapeutics.com/current

Commentary
COVID-19: Regulatory Landscape of Medicinal and Medical Device Products for Human Use
Paul Beninger
p1444–1450
Published online: June 28, 2020
Abstract
Against the backdrop of the COVID pandemic, the scientific and medical communities are working with all deliberate speed with state-of-the-art technologies to develop diagnostic and therapeutic products that can identify, treat, and prevent infection with SARS-CoV-2. These activities may only be legally conducted with the necessary statutes and regulations in place to facilitate the timely development, manufacturing, evaluation, and distribution of products that meet quality standards. The present regulatory landscape for medicinal and medical products for human use has been shaped by nearly 12 decades of statutory history that followed in reaction to disasters and tragedies. Five distinct, closely woven threads of statutory history have led to the regulatory infrastructure we have in place: (1) standardized processes for routine development of medicinal and medical device products for human use; (2) processes for expedited development to shorten time frames and expand patient populations; (3) mechanisms of Expanded Access to make medicinal products available to patients prior to approval of the US Food and Drug Administration; (4) Emergency Use Authorization during public health emergencies; and (5) the development of pathways for bringing generic drugs and biosimilar biologics to market. These mechanisms are being brought to bear to facilitate the defeat of infection with SARS-CoV-2.

Clinical Therapeutics
August 2020 Volume 42, Issue 8, p1425-1624, e115-e160
http://www.clinicaltherapeutics.com/current

Assessing Participation Burden in Clinical Trials: Introducing the Patient Friction Coefficient
David Cameron, Cara Willoughby, Denise Messer, Marie Lux, Murray Aitken, Kenneth Getz
e150–e159
Published online: July 31, 2020
Abstract
Protocol design complexity, and associated study volunteer burden, negatively impact patient recruitment and retention as well as overall research and development productivity. Complex protocols reduce the willingness of potential clinical trial participants to enroll and reduce retention rates. There have been few systematic assessments of protocol design characteristics to determine the burden placed on study volunteers, although such an assessment would offer a compelling opportunity to optimize trial designs and improve recruitment and retention performance. To be useful, an assessment would need to be patient-centric, and focused on the factors that influence participation throughout the clinical trial. Such an assessment would also need to accommodate the unique cost-value trade-off compared with current treatment patterns that each participant makes when choosing to participate and remain in a clinical trial. This article proposes a new methodology to quantify patient burden: the clinical trial patient friction coefficient (PFC). A case example is provided to illustrate the utility of the PFC. A number of applications for the PFC are envisioned: standardizing patient burden assessment to evaluate clinical trial design feasibility, shedding light on the impact of patient burden on clinical trial economics and performance, and conducting sensitivity analyses to identify factors that most reduce patient burden and improve the performance and efficiency of clinical trials.

Clinical Trials
Volume 17 Issue 5, October 2020
https://journals.sagepub.com/toc/ctja/17/5

Perspective
Clinical trials in the time of a pandemic
Susan S Ellenberg
First Published July 10, 2020; pp. 467–471
Abstract
The first rumblings about a new coronavirus spreading in China were heard in January 2020. By the end of that month, the World Health Organization, recognizing the severity of the disease and the potential for global spread, had declared a public health emergency. By February 2020, cases had been identified in multiple countries, clinical trials of treatments with some biological plausibility had begun in China, and the initial steps of vaccine development were underway. In mid-March, by which time countries around the world were experiencing rapidly increasing numbers of cases and deaths, the World Health Organization categorized the outbreak as a pandemic. This new coronavirus was designated SARS-COV-2 in recognition of its similarity to the coronavirus responsible for the severe acute respiratory syndrome outbreak in 2002–2003. The race is on to develop treatments that can mitigate the severe consequences of infection and vaccines that can prevent infection and/or diminish the severity of disease in those who do get infected. Many challenges face these development efforts. Some are similar to those faced in the past; others are new. The urgency of finding ways to treat, and ultimately prevent, the consequences of this new and potentially deadly infection has led to unprecedented focus on clinical trials.

Clinical Trials
Volume 17 Issue 5, October 2020
https://journals.sagepub.com/toc/ctja/17/5

Research Letter
COVID-19 impact on multi-site recruitment and enrollment
Emma Strujo, Mechelle Sanders, Kevin Fiscella, Marie Thomas, Brent Johnson, Alex Deets, Claudia Sanchez Lucas, Tameir Holder, Nina Johal, Amneris Luque, Andrea Cassells, Stephen Williams, Jonathan N Tobin
First Published August 20, 2020; pp. 501–504

Emerging Infectious Diseases
Volume 26, Number 10—October 2020
http://wwwnc.cdc.gov/eid/

Research
Effectiveness of 23-Valent Pneumococcal Polysaccharide Vaccine against Invasive Pneumococcal Disease in Adults, Japan, 2013–2017

Expert Review of Vaccines
Vol 19 (8) 2020
https://www.tandfonline.com/toc/ierv20/current

Review
Fifteen years of experience with the oral live-attenuated human rotavirus vaccine: reflections on lessons learned
Priya Pereira , Volker Vetter , Baudouin Standaert & Bernd Benninghoff
Pages: 755-769
Published online: 04 Sep 2020

Expert Review of Vaccines
Vol 19 (8) 2020
https://www.tandfonline.com/toc/ierv20/current

Editorial
The potential impact of COVID-19 pandemic on the immunization performance in Indonesia
Auliya A. Suwantika , Cornelis Boersma & Maarten J. Postma
Pages: 687-690
Published online: 06 Aug 2020

Global Health: Science and Practice (GHSP)
Vol. 8, No. 3 October 01, 2020
http://www.ghspjournal.org/content/current

ORIGINAL ARTICLES
The Critical Role and Evaluation of Community Mobilizers in Polio Eradication in Remote Settings in Africa and Asia
Judy Lewis, Karen LeBan, Roma Solomon, Filimona Bisrat, Samuel Usman and Ahmed Arale
Global Health: Science and Practice October 2020, 8(3):396-412; https://doi.org/10.9745/GHSP-D-20-00024
Critical community health worker criteria are important for all community programs, including those focused on a single disease. Areas of importance include community engagement, local adaptation, and linkage with the health system—critical areas for current and future epidemics.

Global Health: Science and Practice (GHSP)
Vol. 8, No. 3 October 01, 2020
http://www.ghspjournal.org/content/current

Open Access
Determinants of Facility-Level Use of Electronic Immunization Registries in Tanzania and Zambia: An Observational Analysis
Emily Carnahan, Ellen Ferriss, Emily Beylerian, Francis Dien Mwansa, Ngwegwe Bulula, Dafrossa Lyimo, Anna Kalbarczyk, Alain B. Labrique, Laurie Werner and Jessica C. Shearer
Global Health: Science and Practice October 2020, 8(3):488-504; https://doi.org/10.9745/GHSP-D-20-00134
We provide a framework to quantify the use of electronic immunization registry systems at the facility level and results show the importance of behavioral and organizational factors in explaining their sustained use in Tanzania and Zambia.

Global Health: Science and Practice (GHSP)
Vol. 8, No. 3 October 01, 2020
http://www.ghspjournal.org/content/current

REVIEWS
Open Access
Factors That Influence Data Use to Improve Health Service Delivery in Low- and Middle-Income Countries
Nicole Rendell, Kamalini Lokuge, Alexander Rosewell and Emma Field
Global Health: Science and Practice October 2020, 8(3):566-581; https://doi.org/10.9745/GHSP-D-19-00388
We identified factors that may influence the relationship between information generation and improvement of health service delivery: governance (leadership, participatory monitoring, regular review of data); production of information (presentation of findings, data quality, qualitative data); and health information system resources (electronic health management information systems, organizational structure, training).

Global Public Health
Volume 15, 2020 Issue 10
http://www.tandfonline.com/toc/rgph20/current

Article
Medical populism and the COVID-19 pandemic
Gideon Lasco
Pages: 1417-1429
Published online: 11 Aug 2020
ABSTRACT
This paper uses the vocabulary of ‘medical populism’ to identify and analyse the political constructions of (and responses to) the COVID-19 pandemic in Brazil, the Philippines, and the United States from January to mid-July 2020, particularly by the countries’ heads of state: Jair Bolsonaro, Rodrigo Duterte, and Donald Trump. In all three countries, the leaders’ responses to the outbreak can be characterised by the following features: 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. Taken together, the case studies illuminate the role of individual political actors in defining public health crises, suggesting that medical populism is not an exceptional, but a familiar response to them. This paper concludes by offering recommendations for global health in anticipating and responding to pandemics and infectious disease outbreaks.

Health Policy and Planning
Volume 35, Issue 7, August 2020
https://academic.oup.com/heapol/issue/35/7

Original Articles
Budget line items for immunization in 33 African countries
Ulla K Griffiths, Jennifer Asman, Alex Adjagba, Marina Yo, James O Oguta …
Health Policy and Planning, Volume 35, Issue 7, August 2020, Pages 753–764, https://doi.org/10.1093/heapol/czaa040

Health Policy and Planning
Volume 35, Issue 7, August 2020
https://academic.oup.com/heapol/issue/35/7

The development of a new accountability measurement framework and tool for global health initiatives
Adriane Martin Hilber, Patricia Doherty, Andrea Nove, Rachel Cullen, Tunde Segun …

Health Policy and Planning, Volume 35, Issue 7, August 2020, Pages 765–774, https://doi.org/10.1093/heapol/czz170
Abstract
The Global Strategy for Women’s Children’s and Adolescents’ Health emphasizes accountability as essential to ensure that decision-makers have the information required to meet the health needs of their populations and stresses the importance of tracking resources, results, and rights to see ‘what works, what needs improvement and what requires increased attention’. However, results from accountability initiatives are mixed and there is a lack of broadly applicable, validated tools for planning, monitoring and evaluating accountability interventions. This article documents an effort to transform accountability markers—including political will, leadership and the monitor–review–act cycle—into a measurement tool that can be used prospectively or retrospectively to plan, monitor and evaluate accountability initiatives. It describes the development process behind the tool including the literature review, framework development and subsequent building of the measurement tool itself. It also examines feedback on the tool from a panel of global experts and the results of a pilot test conducted in Bauchi and Gombe states in Nigeria. The results demonstrate that the tool is an effective aid for accountability initiatives to reflect on their own progress and provides a useful structure for future planning, monitoring and evaluation. The tool can be applied and adapted to other accountability mechanisms working in global health.

JAMA Network
COVID-19 Update October 3, 2020

These articles on COVID-19 were published across the JAMA Network in the last week.

Journal of Adolescent Health
October 2020 Volume 67, Issue 4, p461-622
https://www.jahonline.org/issue/S1054-139X(20)X0008-5

Original Articles
Adolescent Barriers to HIV Prevention Research: Are Parental Consent Requirements the Biggest Obstacle?
One third of people newly living with HIV/AIDS are adolescents. Research on adolescent HIV prevention is critical owing to differences between adolescents and adults. Parental permission requirements are often considered a barrier to adolescent enrollment in research, but whether adolescents view this barrier as the most important one is unclear.
Seema K. Shah, Zaynab Essack, Katherine Byron, Catherine Slack, Daniel Reirden, Heidi van Rooyen, Nathan R. Jones, David S. Wendler
p495–501
Published online: July 5, 2020

Journal of Pediatrics
October 2020 Volume 225, p1-288
http://www.jpeds.com/current

Commentary
Seeking Normalcy as the Curve Flattens: Ethical Considerations for Pediatricians Managing Collateral Damage of Coronavirus Disease-2019
Dalia M. Feltman, Gregory P. Moore, Andrew F. Beck, Emily Siffermann, Carlo Bellieni, John Lantos
p233–238
Published online: June 26, 2020

Journal of Travel Medicine
Volume 27, Issue 6, August 2020
https://academic.oup.com/jtm/issue/27/6

Perspectives
Assessing US traveller vaccination access: an evaluation of US requirements for healthcare payer coverage of recommended travel vaccines
Richard Hughes IV, Zach Klein
Journal of Travel Medicine, Volume 27, Issue 6, August 2020, taaa118, https://doi.org/10.1093/jtm/taaa118

Journal of Travel Medicine
Volume 27, Issue 6, August 2020
https://academic.oup.com/jtm/issue/27/6

Original Article
Safety of yellow fever vaccination in pregnancy: findings from a cohort of active duty US military women
Clinton Hall, PhD, Zeina G Khodr, PhD, Richard N Chang, MPH, Anna T Bukowinski, MPH, Gia R Gumbs, MPH …
Journal of Travel Medicine, Volume 27, Issue 6, August 2020, taaa138, https://doi.org/10.1093/jtm/taaa138

The Lancet
Oct 03, 2020 Volume 396 Number 10256 p935-1044, e53-e56
https://www.thelancet.com/journals/lancet/issue/current

Comment
Offline: Science and the breakdown of trust
Richard Horton

The Lancet
Oct 03, 2020 Volume 396 Number 10256 p935-1044, e53-e56
https://www.thelancet.com/journals/lancet/issue/current

Articles
Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial
Remo H M Furtado, et al for the COALITION COVID-19 Brazil II Investigators
The efficacy and safety of azithromycin in the treatment of COVID-19 remain uncertain. We assessed whether adding azithromycin to standard of care, which included hydroxychloroquine, would improve clinical outcomes of patients admitted to the hospital with severe COVID-19…
In patients with severe COVID-19, adding azithromycin to standard of care treatment (which included hydroxychloroquine) did not improve clinical outcomes. Our findings do not support the routine use of azithromycin in combination with hydroxychloroquine in patients with severe COVID-19.

The Lancet
Oct 03, 2020 Volume 396 Number 10256 p935-1044, e53-e56
https://www.thelancet.com/journals/lancet/issue/current

The Lancet Commissions
The Lancet NCDI Poverty Commission: bridging a gap in universal health coverage for the poorest billion
Gene Bukhman, et al for the Lancet NCDI Poverty Commission Study Group
Key messages
:: For the poorest of our world, non-communicable diseases and injuries (NCDIs) account for more than a third of their burden of disease; this burden includes almost 800 000 deaths annually among those aged younger than 40 years, more than HIV, tuberculosis, and maternal deaths combined
:: Despite already living in abject poverty, between 19 million and 50 million of the poorest billion spend a catastrophic amount of money each year in direct out-of-pocket costs on health care as a :: :: :: Progressive implementation of affordable, cost-effective, and equitable NCDI interventions between 2020 and 2030 could save the lives of more than 4·6 million of the world’s poorest, including 1·3 million who would otherwise die before the age of 40 years
:: To avoid needless death and suffering, and to reduce the risk of catastrophic health spending, essential NCDI services must be financed through pooled, public resources, either from increased domestic funding or external funds
:: National governments should set and adjust priorities based on the best available local data on NCDIs and the specific needs of the worst off
:: International development assistance for health should be augmented and targeted to ensure that the poorest families affected by NCDIs are included in progress towards universal health care

Lancet Digital Health
Oct 2020 Volume 2 Number 10 e493-e560
https://www.thelancet.com/journals/landig/issue/current

Editorial
Guiding better design and reporting of AI-intervention trials
The Lancet Digital Health

Lancet Digital Health
Oct 2020 Volume 2 Number 10 e493-e560
https://www.thelancet.com/journals/landig/issue/current

Review
Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension
Xiaoxuan Liu, Samantha Cruz Rivera, David Moher, Melanie J Calvert, Alastair K Denniston and the SPIRIT-AI and CONSORT-AI Working Group
Summary
The CONSORT 2010 statement provides minimum guidelines for reporting randomised trials. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes. The CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a two-day consensus meeting (31 stakeholders), and refined through a checklist pilot (34 participants). The CONSORT-AI extension includes 14 new items that were considered sufficiently important for AI interventions that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human–AI interaction and provision of an analysis of error cases. CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer reviewers, as well as the general readership, to understand, interpret, and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes.

Lancet Digital Health
Oct 2020 Volume 2 Number 10 e493-e560
https://www.thelancet.com/journals/landig/issue/current

Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension
Samantha Cruz Rivera, Xiaoxuan Liu, An-Wen Chan, Alastair K Denniston, Melanie J Calvert and The SPIRIT-AI and CONSORT-AI Working Group
Summary
The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human–AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret, and critically appraise the design and risk of bias for a planned clinical trial.