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

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

Milestones :: Perspectives :: Research

Gavi [to 28 Nov 2020]
https://www.gavi.org/
News releases
24 November 2020
Gavi and IOM join forces to improve immunisation coverage for migrants
:: Memorandum of understanding signed today will strengthen collaboration on vaccination efforts and related health services for migrants and forcibly displaced persons across the world
:: The agreement focuses on reaching missed communities in humanitarian and emergency settings with vaccination
:: Dr Seth Berkley: Reaching migrant, refugee and displaced populations “becomes all the more important as we plan to rollout COVID-19 vaccines worldwide.”
:: António Vitorino: Vaccines are key to keep people on the move and the communities they live in as safe as possible.

Geneva, 24 November 2020 – Today, Gavi the Vaccine Alliance and the International Organization for Migration (IOM) signed a memorandum of understanding to strengthen their collaboration on vaccination efforts and related health services for migrants and forcibly displaced persons across the world, both regarding routine immunisations as well as in response to outbreaks. This milestone will be particularly critical in ensuring that migrants and other people on the move are considered and included, as the world continues its efforts to find a safe COVID-19 vaccine and is developing mechanisms, such as the COVAX Facility, to ensure a fair distribution so that as many lives as possible can be saved.

“Despite enormous progress over the past two decades ensuring children everywhere have access to lifesaving vaccines, 14 million children every year still miss out on basic vaccines,” said Gavi CEO Dr Seth Berkley. “We know a disproportionate amount of these unprotected children come from migrant, refugee and displaced populations, who are too often overlooked when it comes to basic health care. This obviously becomes all the more important as we plan to rollout COVID-19 vaccines worldwide; we cannot allow these populations to miss out on what could be one of our best routes out of this pandemic. That’s why we’re delighted to partner with IOM, to help provide a healthier future to some of the most vulnerable people on earth.”

“Vaccines are one of the most powerful tools we have to keep people on the move, the communities they leave behind and the communities they join as safe and healthy as possible,” stressed IOM Director General António Vitorino. “This reinforced partnership will be critical in helping IOM achieve just that and contribute tangibly to the realization of true universal health coverage.”

The agreement signed by the two organizations focuses on reaching missed communities in humanitarian and emergency settings with vaccination and support routine immunisation through engagement in primary health care systems. The partnership also aims to boost advocacy for the prioritization of vulnerable populations, support operational and policy assistance and facilitate technical collaboration. Specifically, the memorandum of understanding seeks to facilitate collaboration on ensuring the inclusion of migrants, IDPs and refugees in governments’ COVID-19 responses, in particular vaccination efforts…

Milestones :: Perspectives :: Research

COVID-19 Vaccines – Trials/Development

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
Statement on continuation of vaccine trials
We, (ICMRA members, a global coalition of medicine regulators) have an important role in supporting the worldwide effort to ensure the quality, safety and efficacy of licensed vaccines and to make them available to the public. We have stepped up our global collaboration to facilitate and expedite the development and evaluation of vaccines against SARS-CoV2 (causing COVID-19 disease).

This statement in support of continuing COVID-19 vaccine trials to collect critical data to support regulatory actions and deployment, for as long as is feasible, is intended for all stakeholders, vaccinees, researchers and investigators, academia, regulators and the pharmaceutical industry.

The pandemic represents a major global unsolved public health and economic crisis, which is still far from being under control as we see peaks of transmission, morbidity and mortality over time in different locations. The availability of safe and effective vaccines is anticipated to be an important component of the overall response to the emergency and to contribute to a return to normality.

Regulators have set up flexible and agile procedures to facilitate the swift analysis of clinical trial results submitted to them. These analyses will support clear, independent and transparent benefit-risk evaluations, leading to decisions on the approval of, or early access to, safe and effective vaccines against COVID-19.

To determine that the benefit of a vaccine outweighs its potential risk, regulators need robust and convincing evidence of the safety and efficacy that is obtained from well-designed randomised and controlled trials. Initial positive evidence of the vaccine’s safety and efficacy used to support a regulatory action may be based on planned interim or final analyses that occur when a pre-defined number of cases of COVID-19 disease have occurred in a clinical trial. In these situations, it will be of the utmost importance to continue gathering data about the vaccine safety and efficacy in the longer-term after the interim or final analysis is completed.

Specifically, continued follow-up of clinical trial participants after a regulatory decision has been made can provide important additional and more precise information on longer-term safety and efficacy against specific aspects of SARS-CoV-2 disease or infection, including efficacy against severe disease, efficacy in important subgroups, potential risks of vaccine-induced enhanced disease and whether protection against COVID-19 disease wanes over time.

Thus, continued evaluation of the vaccinated and the unvaccinated (control subjects who do not receive a vaccine against COVID-19) groups in clinical trials for as long as feasible will provide invaluable information.  

For these reasons, investigators and sponsors should develop strategies to ensure continuation of follow-up of vaccinated and control groups for as long as possible after any regulatory approval that is based on planned analyses conducted while trials are still ongoing and after final analyses are completed.

Therefore, unless maintaining participants in their randomised treatment groups (vaccinated or control) after a vaccine is approved is clearly infeasible, we recommend that clinical trials should proceed as initially planned with a follow-up of at least one year or more from completion of assigned doses. In making this recommendation, we recognise that the feasibility of maintaining the group assignment for at least one year will depend on factors such as the population enrolled into a trial (e.g. in terms of whether they are young and healthy or have reasons to be predisposed to develop severe COVID-19), informed decisions made by clinical trial participants, the availability of COVID-19 vaccine(s), and the characteristics of SARS-CoV-2 epidemics. It will be necessary for sponsors, investigators, public health authorities and regulators to assess each situation that may arise.

Milestones :: Perspectives :: Research

COVID-19 Vaccines Regulatory Processes :: Announcements/Meeting Dates/Milestones

Week of 23 November 2020
CHINA – Leading vaccine maker seeks market approval
2020-11-26
Leading COVID-19 vaccine developer Sinopharm has submitted a market approval application to China’s top market regulator, Xinhua News Agency quoted the company’s Deputy General Manager Shi Shengyi as saying on Nov 25.
The Chinese company has two experimental COVID-19 vaccines – both of which are the inactivated type – undergoing Phase 3 clinical trials overseas.
The Xinhua report did not reveal details about the application.

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Week of 30 November 2020
U.K. – UK set to approve Pfizer-BioNTech Covid vaccine within days
Rollout of two-shot jab could begin as soon as December 7
28 November 2020 Sebastian Payne and Donato Paolo Mancini
The UK is poised to become the first western country to approve a Covid-19 vaccine, with the independent regulator set to grant approval within days. Deliveries of the vaccine developed by BioNTech and Pfizer would begin within hours of the authorisation, according to government officials. The first injections could take place from December 7. The UK has ordered 40m doses of the two-shot product, which preliminary data found to be more than 95 per cent effective in preventing disease. Vaccines would normally be authorised by the European Medicines Agency until the end of the Brexit transition on December 31. However the UK’s Medicines and Healthcare Products Regulatory Agency has the power to temporarily authorise products, in cases of urgent public need…

UK MHRA Medicines and Healthcare products Regulatory Agency
:: Pfizer/BioNTech COVID-19 vaccine: MHRA statement 23 November 2020
…Approval process for a potential COVID-19 vaccine
:: Until the end of December, and as part of the transition period, COVID-19 vaccine candidates can be licensed (authorised) via the European Medicines Agency (EMA) and that authorisation will automatically be valid in the UK.
:: However, if a suitable COVID-19 vaccine candidate, with strong supporting evidence of safety, quality and effectiveness from clinical trials becomes available before the end of the transition period, EU legislation allows for temporary authorisation of supply in the UK, based on the public health need.
:: The MHRA will evaluate the data rigorously for quality, safety and effectiveness to reach an independent, scientifically robust opinion. The data must include results from lab and clinical trials in humans; manufacturing and quality controls, product sampling, and testing of the final product.
:: Any COVID-19 vaccine candidate submitted after the transition period ends in January 2021 will not need to go through a European marketing authorisation for use in Great Britain and will instead be assessed directly by the MHRA. The MHRA is globally recognised for requiring the highest standards of safety, quality and effectiveness for any vaccine.

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1 December 2020 – Tuesday – 1400-1700/New York
Advisory Committee on Immunization Practices (ACIP)
Webcast: December 1, 2020 meeting is a virtual meeting. No registration is required.
Meeting time, 1400 – 1700 EDT (times subject to change).
Webcast Link
Meeting Agenda
Selected Agenda Elements
:: Allocation of initial supplies of COVID-19 vaccine: Phase 1a Dr. Kathleen Dooling (CDC/NCIRD)
:: Clinical considerations for populations included in Phase 1a Dr. Sara Oliver (CDC/NCIRD)
:: Post-authorization safety monitoring update Dr. Tom Shimabukuro (CDC/NCEZID)
:: Public Comment
VOTE
:: Allocation of initial supplies of COVID-19 vaccine: Phase 1a Dr. Kathleen Dooling (CDC/NCIRD)

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4 December 2020 – Friday – 1300-1700/New York
U.S. – National Vaccine Advisory Committee NVAC Meeting (Virtual)
Selected Agenda Elements
OPENING REMARKS
Admiral Brett Giroir, Assistant Secretary for Health
APPROACHES TO INCLUDE PREGNANT WOMEN IN COVID-19 CLINICAL TRIALS
Dr. Sascha Ellington, Centers for Disease Control and Prevention
Dr. Ruth Faden, Johns Hopkins University
Dr. Jeff Roberts, Food and Drug Administration
Dr. Linda Eckert, American College of Obstetricians and Gynecologists
Dr. Titi Oduyebo, Centers for Disease Control and Prevention
VACCINE SAFETY SYSTEMS AND COVID-19
Dr. Peter Marks, Food and Drug Administration
Dr. Arnold Monto, Vaccines and Related Biological Products Advisory Committee
Dr. Tom Shimabukuro, Centers for Disease Control and Prevention
Dr. Sonali Kochhar, University of Washington
REGISTER: https://www.hhs.gov/webforms/nvac/index.html

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10 December 2020 – Thursday – 0900-1800/New York
FDA – Vaccines and Related Biological Products Advisory Committee
The FDA’s Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.
Webcast Information
CBER plans to provide a free of charge, live webcast of the Vaccines and Related Biological Products Advisory Committee meeting. If there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. The online web conference meeting will be available at the following:
https://youtu.be/owveMJBTc2IExternal Link Disclaimer
https://twitter.com/US_FDAExternal Link Disclaimer (Supported in Chrome browser)
https://fda.yorkcast.com/webcast/Play/d75d80a3eb6e419986181c1a881fe2671d.

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11 December 2020 – Thursday – 1300-1630/CET
EMA Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU
:: Agenda – EMA public stakeholder meeting on COVID-19 (PDF/310.91 KB) (new)
:: Documents
:: Live broadcast
EMA is organising this virtual meeting to explain the processes for the development, evaluation, approval and safety monitoring of COVID-19 vaccines in the EU, including EMA’s specific role, to all interested parties.
It will also give the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns, that will be considered by EMA and the European medicines regulatory network in the decision-making process.
Please note that some issues of high public interest, such as patient access to COVID-19 vaccines and national vaccination campaigns, lie outside EMA’s remit and will not be covered at this event.

EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.
Last updated: 16/11/2020
MA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. (a subsidiary of Moderna, Inc.)…The rolling review will continue until enough evidence is available to support a formal marketing authorisation application…

Milestones :: Perspectives :: Research

Editor’s Note:
To better present a global view of COVID-19 vaccine development, regulatory review, procurement and deployment, we will present headlines from this site – which provides as its contact point the Russian Direct Investment Fund [RDIF].

Sputnik V – “the first registered COVID-19 vaccine” [to 28 Nov 2020]
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
RDIF and Hetero agree to produce over 100 million doses of the Sputnik V vaccine in India
Press release, 27.11.2020

The cost of one dose of the Sputnik V vaccine will be less than $10 for international markets
Press release, 24.11.2020

Second interim analysis of clinical trial data showed a 91.4% efficacy for the Sputnik V vaccine on day 28 after the first dose; vaccine efficacy is over 95% 42 days after the first dose
Press release, 24.11.2020

Milestones :: Perspectives :: Research

COVID-19 Vaccines :: Procurement/Distribution/Logistics

Moderna Announces the European Commission’s Approval of Advance Purchase Agreement for Initial 80 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
Option granted to European Commission to purchase up to an additional 80 million doses
Agreement reflects Moderna’s commitment to make its vaccine available in multiple countries

November 25, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the European Commission has approved an agreement to secure 80 million doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19, as part of the European Commission’s goal to secure access to a safe and effective COVID-19 vaccine for Europe.
Under the terms of the proposed agreement, the European Commission has the option to increase their purchase of mRNA-1273, from 80 million doses to a total of up to 160 million doses. The agreement will be finalized following a brief review period by the European Union Member States. This announcement follows the conclusion of advanced exploratory talks with the European Commission that began on August 24, 2020. Delivery of the vaccine could begin as early as the first quarter 2021 if it is approved for use by the European Medicines Agency (EMA) human medicines committee (CHMP), which started a rolling review of mRNA-1273 on November 17…

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COVAXX Announces $2.8 Billion in Advance Purchase Commitments to Deliver More Than 140 Million Vaccine Doses to Emerging Countries
:: COVAXX’s UB-612 is the only multitope, synthetic peptide-based vaccine candidate in the clinic
:: Company’s manufacturing facilities in place to produce 100 million doses in 1H 2021 and up to 1 billion by YE 2021
:: UB-612 distribution utilizes normal refrigeration (no freezing required)
:: Company partnered with Maersk for worldwide shipping and logistics
:: Phase 2/3 clinical trials to begin end of 2020/1Q 2021 in Asia, Latin America, and U.S.

November 25, 2020
HAUPPAUGE, N.Y.–(BUSINESS WIRE)–COVAXX, a U.S. company developing a multitope peptide-based vaccine to fight COVID-19, announces advanced purchase commitments of more than 140 million doses of its UB-612 vaccine, totaling over $2.8 billion, to deliver vaccines in multiple countries, including Brazil, Ecuador and Peru. These public and private commitments follow the start of human trials in Taiwan and the September agreement with Diagnosticos da America SA (Dasa S.A.), the largest clinical diagnostic company in Brazil, to conduct Phase 2/3 clinical trials and distribute vaccines within Brazil.

“In parallel with the expedited clinical development of UB-612, we are working to help countries with the greatest unmet needs customize their plans for vaccine studies, supply and distribution,” said Mei Mei Hu, co-founder and CEO of COVAXX. “The realistic view of vaccine production is that we will need a wide range of vaccine options utilizing different technologies to meet worldwide demand. As much as vaccines matter, vaccinations matter more. To be administered effectively, vaccines need to demonstrate easy and affordable distribution, durability of response with the capability to further extend it with effective boosts, as well as the ability to adapt to a potential mutation in the virus while building on the first vaccines made available.”

COVAXX (not to be confused with single “x” COVAX) is currently completing Phase 1 clinical trials of UB-612 in Taiwan and has an agreement with the University of Nebraska Medical Center (UNMC), home of the National Pandemic Center, to also conduct trials in the U.S. Last month, COVAXX announced a global logistics partnership with Maersk, the world’s largest shipping and integrated logistics provider, that creates a framework for all transportation and supply chain services that will be needed to deliver COVAXX’s UB-612 around the world…

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COVAX Update: UNICEF working with global airlines and freight providers to plan delivery of COVID-19 vaccines
UNICEF kickstarts discussions with over 350 logistics organizations to step up delivery plans for eventual COVID-19 vaccines

NEW YORK, 23 November 2020: UNICEF is working with major global airlines and freight providers to step up efforts to deliver COVID-19 vaccines to over 92 countries around the world as soon as vaccines become available.

To kickstart preparations, UNICEF together with the Pan American Health Organization (PAHO) and the International Air Transport Association (IATA), briefed major global airlines last week on the expected capacity requirements and discussed ways to transport close to 2 billion doses of COVID-19 vaccines in 2021. This is in addition to the 1 billion syringes that need to be transported by sea-freight. 

This virtual meeting comes close on the heels of the first-ever logistics event held virtually by UNICEF to discuss the transportation of COVID-19 vaccines. The landmark discussion brought together more than 350 logistics partners, including air freight operators, shipping lines and global logistics associations.

“As work continues to develop COVID-19 vaccines, UNICEF is stepping-up efforts with airlines, freight operators, shipping lines and other logistics associations to deliver life-saving vaccines as quickly and safely as possible,” said Etleva Kadilli, Director of UNICEF’s Supply Division. “This invaluable collaboration will go a long way to ensure that enough transport capacity is in place for this historic and mammoth operation. We need all hands on deck as we get ready to deliver COVID-19 vaccine doses, syringes and more personal protective equipment to protect front line workers around the globe. By protecting these workers, we are ultimately protecting the millions of children who depend on their critical services.”

In the coming weeks, UNICEF is also assessing existing transport capacity to identify gaps and future requirements. The procurement, delivery and distribution of COVID-19 vaccines is anticipated to be the largest and fastest such operation ever undertaken. UNICEF is leading efforts to procure and deliver vaccines from manufacturers that have agreements with the COVAX Facility.  In collaboration with PAHO, UNICEF will coordinate the purchase and delivery for 92 low- and lower middle-income economies as quickly and securely as possible.

These efforts build on UNICEF’s longstanding efforts with the logistics industry to transport supplies around the world despite restrictions related to the pandemic. Since January, UNICEF has delivered more than US$190 million worth of COVID-19 supplies such as masks, gowns, oxygen concentrators and diagnostic test kits in support of countries as they respond to the pandemic.

As the largest single vaccine buyer in the world, UNICEF normally procures more than 2 billion doses of vaccines annually for routine immunization and outbreak response on behalf of nearly 100 countries. This unparalleled expertise includes the coordination of thousands of shipments with various cold chain requirements, making UNICEF an expert in supply chain management of temperature-controlled products, which is especially needed during this historic undertaking. To minimise disruptions to routine immunization programmes due to the operations related to the COVID-19 vaccines and syringes, UNICEF and partners will continue to coordinate closely with logistics operators for timely delivery around the world.

“The support of governments, partners and the private sector will be paramount to transport vaccines for deadly diseases such as measles, diphtheria and tetanus, as well as for COVID-19, as efficiently as possible,” Kadilli said.

Last month, UNICEF began a process to stockpile more than 1 billion syringes by 2021 to guarantee initial supply and pre-position in advance of COVID-19 vaccines.

Milestones :: Perspectives :: Research

Ad Council Launches $50 Million Fund for National COVID-19 Vaccine Education Effort
With many Americans not yet committed to getting a COVID-19 vaccine when available, leaders in communications, policy and health unite to create a research-driven public education campaign
NEW YORK, Nov. 23, 2020 /PRNewswire/ — The Ad Council today announced plans for a communications effort to encourage vaccination against the virus, which will represent one of the largest public education campaigns in history. This effort will be launched in partnership with the COVID Collaborative, a national assembly that has brought together leading experts and institutions across health, education and the economy to turn the tide on the pandemic by supporting state and local officials.
This national initiative will complement government efforts and has set an initial goal of raising $50 million from the private sector, including the philanthropic community and corporations. This effort will be guided by science and health experts from the COVID Collaborative, amplified by partnerships across every sector and rooted in extensive research with key audiences…

EMERGENCIES

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

Weekly Epidemiological and Operational updates
last update: 14 November 2020, 10:30 GMT-4
Confirmed cases :: 61 299 371 [week ago: 57 274 018] [two weeks ago: 53 164 803]
Confirmed deaths :: 1 439 784 [week ago: 1 368 000] [two weeks ago: 1 300 576]
Countries, areas or territories with cases :: 220

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Weekly epidemiological update – 24 November 2020
Overview
This past week, the global acceleration in case incidence has slowed down, with around 4 million new cases reported; however, death rates continue to increase with over 67 000 new deaths reported.

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Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 25 November 2020
:: Fahima Ahmed Hassan is a 25-year-old community mobilizer who goes the extra mile to ensure parents of children under the age of five are informed of Somalia’s polio vaccination campaigns and are ready for their children to be vaccinated. Read about Fahima and other Community mobilizers who build trust with communities ahead of crucial vaccination campaigns.
:: The GPEI has published an Interim guidance document on the use of Novel Oral Polio Vaccine type 2 (nOPV2) which is meant to provide context and policy guidance on the use of nOPV2 in response to Type 2 circulating Vaccine-Derived Poliovirus (cVDPV2) during the Initial Use Period. This document is an addendum to the “Standard Operating Procedures: Responding to a poliovirus event or outbreak”, Version 3.1’ (SOPs) (5).

Summary of new WPV and cVDPV viruses this week (AFP cases and ES postitives):
:: Afghanistan: two WPV1 cases, 24 cVDPV2 cases and 18 cVDPV2 positive environmental samples
:: Pakistan: two WPV1 positive environmental samples and 21 cVDPV2 cases
:: Burkina Faso: four cVDPV2 cases
:: Côte d’Ivoire: 16 cVDPV2 cases and 4 cVDPV2 positive environmental samples
:: Niger: two cVDPV2 cases
:: South Sudan: seven cVDPV2 cases and 2 cVDPV2 positive environmental samples
:: Sudan: two cVDPV2 cases
:: Somalia: one cVDPV2 case and one cVDPV2 positive environmental sample
:: Yemen: two cVDPV1 cases

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Editor’s Note:
A number of country pages below did not load at inquiry.

WHO Grade 3 Emergencies [to 28 Nov 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 28 Nov 2020]
Iraq
:: Restoration works completed at East Erbil Emergency Hospital and specialized services resumed for patients 24 November 2020

Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burkina Faso – 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
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 28 Nov 2020]

Djibouti
:: Djibouti se prépare aux Journées nationales de vaccination contre la poliomyélite
25 novembre 2020 – Près de 130 000 enfants de Djibouti vont être vaccinés contre le poliovirus dans le cadre d’une campagne de vaccination nationale contre la poliomyélite qui devrait débuter lundi 23 novembre et s’étendra sur quatre jours

Chad – No new digest announcements identified
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 – No new digest announcements identified
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.
East Africa Locust Infestation
:: Desert Locust situation update – 24 November 2020

COVID-19
:: Coronavirus Disease (COVID-19): Weekly Epidemiological Update (24 November 2020)

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WHO & Regional Offices [to 28 Nov 2020]

Webinar: a multilateral response to misinformation and data transparency
30 November 2020 15:00 – 17:00 CET

26 November 2020 Departmental news
WHO releases new guidance on integrating mental health in radiological and nuclear emergency response

25 November 2020 News release
Every move counts towards better health – says WHO

25 November 2020 Departmental news
Update: WHO revision of pain management guidelines

23 November 2020 Departmental news
Countdown to 2030 launches expanded 2020 country profiles on early childhood development

23 November 2020 Departmental news
The city of lights glows teal for cervical cancer elimination

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Weekly Epidemiological Record 27 November 2020, Vol. 95, No. 48, pp. 585–608
:: Meeting of the Strategic Advisory Group of Experts on Immunization, October 2020 –
conclusions and recommendations

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
No new digest content identified

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
:: Act now to address the shadow pandemic of violence against women
25 November 2020 Statement SEARO
By Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia
Urgent action is needed across the WHO South-East Asia Region to strengthen efforts to protect women and girls from violence and to support their health needs amid the ongoing COVID-19 pandemic…

WHO European Region EURO
:: WHO and ECDC call for improved HIV testing in Europe 26-11-2020
:: WHO’s Emergency Medical Teams inspire countries and colleagues during the COVID-19 pandemic 25-11-2020
:: COVID-19 update: doing our share, a new horizon with technological and pharmaceutical development, and preserving the rights of children (delivered in Russian) 24-11-2020
:: Health workers at risk, older adults and residents of long-term care facilities to be prioritized for COVID-19 vaccination 23-11-2020

WHO Eastern Mediterranean Region EMRO
:: WHO supports civil/military cooperation on COVID-19 database
26 November 2020 – A collaborative initiative between the Lebanese army and the Ministry of Public Health, supported by WHO, has created a comprehensive database for COVID-19 cases in Lebanon.
Dr Iman Shankiti, WHO Representative in Lebanon, accompanied by a WHO team, visited the army hospital in Badaro, Beirut, to review equipment installed by WHO for the project.
This initiative falls under a project to create civil/military cooperation during the pandemic through the exchange of information between the Ministry of Public Health and the Lebanese army on cases and other areas related to the coronavirus. This approach has been pioneered by Lebanon, with WHO providing equipment and training for the army with the support of the Ministry.

WHO Western Pacific Region
No new digest content identified

CDC/ACIP [to 28 Nov 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
COVID-19 Travel Health Notice Levels and Testing for International Travelers
Sunday, November 22, 2020
…CDC’s Travel Health Notices inform travelers and clinicians about current health issues in destinations around the world. For most diseases, the Travel Health Notices have 3 levels. This new 4-level travel health notice system is specific to COVID-19 and details the level of COVID-19 in international destinations and U.S. territories.

Advisory Committee on Immunization Practices (ACIP)
Webcast: December 1, 2020 meeting is a virtual meeting. No registration is required.
Meeting time, 1400 – 1700 EDT (times subject to change).
Webcast Link
Meeting Agenda

Coronavirus Disease 2019 (COVID-19)
Selected Resources
:: The Advisory Committee on Immunization Practices’ Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine – United States, 2020 Wednesday, November 25, 2020
:: How CDC Is Making COVID-19 Vaccine Recommendations Wednesday, November 25, 2020
:: Frequently Asked Questions about COVID-19 Vaccination Tuesday, November 24, 2020

MMWR News Synopsis Friday, November 27, 2020
:: Decline in SARS-CoV-2 Antibodies After Mild Infection Among Frontline Health Care Personnel in a Multistate Hospital Network — 12 States, April–August 2020
:: Implementation of Hospital Practices Supportive of Breastfeeding in the Context of COVID-19 — United States, July 15–August 20, 2020
:: COVID-19 Outbreak Associated with a 10-Day Motorcycle Rally in a Neighboring State — Minnesota, August–September 2020 (Early release November 20, 2020)
:: Trends in County-Level COVID-19 Incidence in Counties With and Without a Mask Mandate — Kansas, June 1–August 23, 2020 (Early release November 20, 2020)
:: The Advisory Committee on Immunization Practices’ Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine — United States, 2020 (Early release November 23, 2020)

Africa CDC [to 28 Nov 2020]
http://www.africacdc.org/
News
#AfricaMaskWeek launches to build continent-wide movement for mask-wearing
ADDIS ABABA, ETHIOPIA, 23 NOVEMBER 2020. #AfricaMaskWeek launches today across the continent, from 23 to 30 November 2020. Led by the Pandemic Action Network, in partnership with the Africa Centres for Disease Control and Prevention (Africa CDC), the African Union Office of the Youth Envoy, the African Youth Front on Coronavirus, Resolve to Save Lives, and many other organizations, this week-long social media campaign will encourage mask-wearing across the African continent…

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

National Health Commission of the People’s Republic of China [to 28 Nov 2020]
http://en.nhc.gov.cn/
News
Nov 28: Daily briefing on novel coronavirus cases in China
On Nov 27, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 6 new cases of confirmed infections.

Leading vaccine maker seeks market approval
2020-11-26
Leading COVID-19 vaccine developer Sinopharm has submitted a market approval application to China’s top market regulator, Xinhua News Agency quoted the company’s Deputy General Manager Shi Shengyi as saying on Nov 25.
The Chinese company has two experimental COVID-19 vaccines – both of which are the inactivated type – undergoing Phase 3 clinical trials overseas.
The Xinhua report did not reveal details about the application.
Liu Jingzhen, chairman of Sinopharm, said previously that hundreds of thousands of people in China have been injected with either one of the vaccines through emergency authorization, and 56,000 of them have traveled abroad after inoculation.
No severe adverse effects have been observed among them, and none of those now living overseas has been infected with the virus, he said.
Regarding the overseas trials, Liu said nearly 60,000 volunteers from 10 countries have been enrolled in the program, and preliminary results are satisfactory.
The company’s production capability is expected to exceed 1 billion doses by the end of next year.
China now has five COVID-19 vaccines in Phase 3 clinical trials in foreign countries, making it a front-runner in the global race to create a safe, effective vaccine.

National Medical Products Administration [to 28 Nov 2020]
http://english.nmpa.gov.cn/news.html
News
Leading vaccine maker seeks market approval
2020-11-26
[See above]

Announcements

Paul G. Allen Frontiers Group [to 28 Nov 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

BARDA – U.S. Department of HHS [to 28 Nov 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

BMGF – Gates Foundation [to 28 Nov 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

Bill & Melinda Gates Medical Research Institute [to 28 Nov 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 28 Nov 2020]
https://carb-x.org/
News
No new digest content identified.

CEPI – Coalition for Epidemic Preparedness Innovations [to 28 Nov 2020]
http://cepi.net/
Latest News
The Republic of Korea provides US $9 million contribution to CEPI to advance vaccine development and prepare for future outbreaks
The financial contribution was announced at a virtual signing ceremony attended by Ambassador Nam, Head of the Embassy of the Republic of Korea to Norway, and CEPI CEO, Dr. Richard Hatchett.
COVID-19 25 Nov 2020

Ensuring safety of COVID-19 vaccines
Dr Robert Chen, leading vaccine-safety expert, discusses the importance of safety monitoring for COVID-19 vaccines
COVAX 24 Nov 2020

Indonesia donates US $1 million to further CEPI’s vaccine research and combat epidemic threats
The financial contribution will further vaccine programmes against CEPI’s target diseases.
COVAX 24 Nov 2020

CEPI welcomes University of Oxford / AstraZeneca encouraging interim COVID-19 vaccine efficacy data
“It is terrific to see another approach to vaccine development also yielding such positive findings on an interim analysis,” says CEPI CEO, Richard Hatchett.
23 Nov 2020

EDCTP [to 28 Nov 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
24 November 2020
Largest clinical trial in Africa to treat mild to moderate COVID-19 patients launched in 13 countries
Thirteen African countries and an international network of research institutions have joined forces to launch the largest clinical trial in mild-to-moderate COVID-19 outpatients in Africa. The ANTICOV clinical trial aims to identify treatments for these cases and thus to contribute to the prevention of spikes in hospitalisation that could overwhelm health systems in Africa.*

The trial will be conducted by the ANTICOV consortium. It includes 26 prominent African and global R&D organisations. It is coordinated by the Drugs for Neglected Diseases initiative (DNDi).

Funding
Major funding for the ANTICOV consortium is provided by the German Federal Ministry of Education and Research (BMBF) and by the global health agency Unitaid. Early support to launch the initiative was provided by EDCTP under its Covid-19 Emergency call with additional funding from the Swedish government, and the Starr International Foundation, Switzerland. This funding contributed to finalising the study protocol and facilitating expedited reviews by in-country regulatory and ethics authorities. It also supported the timely preparation of trial sites in selected African countries and a robust, standardised data management system.

Study approach
ANTICOV clinical trials will be carried out at 19 sites in Burkina Faso, Cameroon, Côte d’Ivoire, the Democratic Republic of Congo (DRC), Equatorial Guinea, Ethiopia, Ghana, Guinea, Kenya, Mali, Mozambique, Sudan, and Uganda. The study is an open-label, randomised, comparative, ‘adaptive platform trial’ that will test the safety and efficacy of treatments in 2,000 to 3,000 mild-to-moderate COVID-19 patients. The adaptive platform trial is an innovative type of clinical trial pioneered for cancer drugs. It allows for several treatments to be tested simultaneously. Adaptive platform trials enable rapid decisions based on the ongoing analysis of results.

The study will begin testing, against a control arm, the HIV antiretroviral combination lopinavir/ritonavir and the malaria drug hydroxychloroquine, which remains the standard of care for COVID-19 today in numerous African countries.

All clinical trial data generated by ANTICOV will be integrated and shared openly and transparently to inform public health policy. Every effort will be made to work with all relevant partners to ensure that treatments that prove safe and effective will be affordable, available, and accessible for all…

Emory Vaccine Center [to 28 Nov 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Medicines Agency [to 28 Nov 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up
Last updated: 27/11/2020

News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 November 2020
PRAC, Last updated: 27/11/2020

News: Call for expressions of interest for Committee for Orphan Medicinal Products (COMP) members positions representing patient organisations
COMP, Last updated: 24/11/2020

News: Workshop on regulatory support for development of orphan medicines
COMP, Last updated: 23/11/2020
On Monday, 30 November, EMA is hosting a workshop to discuss the benefits and impact of early regulatory interactions and incentives for the development of medicines for rare diseases.

European Vaccine Initiative [to 28 Nov 2020]
http://www.euvaccine.eu/
Latest News
Nov 16, 2020
RICH Symposium on “Research Infrastructures as Engines for Maximising Impact of Horizon Europe
The RICH Symposium on “Research Infrastructures as Engines for Maximising Impact of Horizon Europe” brought together around 180 participants in the session dedicated to Health & Food. Speakers -including representatives from the European Commission and different Research Infrastructures initiatives- shared their views and expectations regarding how Research Infrastructures could become key components of the Horizon Europe Missions and other parts of the upcoming framework programme…

FDA [to 28 Nov 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
November 25, 2020 – Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators

November 24, 2020 – Coronavirus (COVID-19) Update: November 24, 2020
…Also today, the FDA posted two templates with recommendations on what to include in EUA requests for serology tests. These templates provide the FDA’s current recommendations on what data and information should be submitted to the FDA in support of an EUA request or Pre-EUA submission for a SARS-CoV-2 antibody test or home specimen collection devices using dried blood spot. The ..FDA, but alternative approaches can be used…

November 23, 2020 – Coronavirus (COVID-19) Update: November 23, 2020
…The FDA also recently posted a new infographic, The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization, to explain a potential pathway for vaccines.

November 23, 2020 – FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention
…“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Americans will have to be more vigilant than ever as these viruses spread concurrently.”…

November 21, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions.
…“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” said FDA Commissioner Stephen M. Hahn, M.D. “As part of our Coronavirus Treatment Acceleration Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while continuing to study the safety and effectiveness of these treatments.”
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Casirivimab and imdevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.
“The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research. “We will continue to facilitate the development, evaluation and availability of COVID-19 therapies.”…

FDA – COVID-19 Vaccines [to 28 Nov 2020]
www.fda.gov/covid19vaccines
Upcoming Events
Vaccines and Related Biological Products Advisory Committee
12/10/2020
The FDA’s Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.

Fondation Merieux [to 28 Nov 2020]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation co-organized event
7th Meeting of the GTFCC Working Group on Oral Cholera Vaccine Webinars
November 19 – December 10, 2020 – Webinars

Gavi [to 28 Nov 2020]
https://www.gavi.org/
News releases
24 November 2020
Gavi and IOM join forces to improve immunisation coverage for migrants
Memorandum of understanding signed today will strengthen collaboration on vaccination efforts and related health services for migrants and forcibly displaced persons across the world
[See Milestones above for detail]

24 November 2020
Gavi statement on AstraZeneca/Oxford interim efficacy data

GHIT Fund [to 28 Nov 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.

Global Fund [to 28 Nov 2020]
https://www.theglobalfund.org/en/news/
News
44th Board Meeting Documents

26 November 2020
The Board of the Global Fund held its Forty-Fourth Meeting on 11-12 November 2020. Documents from the meeting are now available on the 44th Board Meeting page.

COVID-19 Situation Report
24 November 2020
A new issue of the COVID-19 Situation Report is available: Situation Report – 24 November 2020 download in English

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 28 Nov 2020]
https://www.glopid-r.org/news/
News
No new digest content identified.

Hilleman Laboratories [to 28 Nov 2020]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 28 Nov 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
Special Issue 3: Interim Efficacy Results Reported for Third COVID-19 Vaccine Candidate
Nov 23, 2020
By Wayne Koff, Ph.D.
President & CEO
AstraZeneca announced results today from an interim analysis of its COVID-19 vaccine candidate that indicate the vaccine is 70% effective on average, according to an ongoing Phase III trial in the U.K. and Brazil. The vaccine candidate is the first of the viral vector platform vaccines to demonstrate efficacy, using an adenovirus that commonly infects chimpanzees to express the SARS-CoV-2 Spike (S) protein. This vaccine was developed in partnership with Oxford University and its spin-off Vaccitech. Both Pfizer/BioNTech and Moderna recently released interim efficacy results for their vaccine candidates, both of which are based on mRNA strategies for delivering vaccine antigens

IAVI [to 28 Nov 2020]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
No new digest content identified.

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
Statement on continuation of vaccine trials
Undated – presume week of 23 Nov 2020
[See COVID-19 Vaccine Development above for detail]

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

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

IFRC [to 28 Nov 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Asia Pacific, Philippines
Typhoon crisis: 305,000 houses wrecked in Philippines
Kuala Lumpur/Manila/Geneva, 26 November 2020 – Consecutive, devastating typhoons in the Philippines have laid the foundations for a long-term humanitarian crisis as more than 305,000 homes have been damaged or destroyed according to humanitarian assess …
26 November 2020

Africa, Ethiopia, Sudan
Sudan: Red Crescent ramps up operation as influx of Ethiopian refugees grows
Khartoum/Nairobi/Geneva, 23 November 2020 – The Sudanese Red Crescent Society has scaled up its operation at the border with Ethiopia to support the growing number of Ethiopian refugees coming into the country. Since fighting began in Ethiopia’s Tigray …
24 November 2020

Institut Pasteur [to 28 Nov 2020]
https://www.pasteur.fr/en/press-area
Press documents
Press Info
19.11.2020
COVID-19: neutralizing immune response lasts longer in women than in men
As part of the SEROCoV-HUS study, teams from Strasbourg University Hospital and the Institut Pasteur monitored 308 hospital staff who had previously contracted a mild form of SARS-CoV-2. The scientists demonstrated that neutralizing antibodies could be detected in 84% of them up to 6 months after infection, but that the level fell more quickly in men than in women. These results seem to suggest that immunity lasts longer in women than in men. The study was published as a preprint on the MedRxiv website.

IRC International Rescue Committee [to 28 Nov 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Statement
As tensions rise in Mekelle, Ethiopia, IRC warns of impending humanitarian disaster
November 27, 2020

Press Release
IRC welcomes President-Elect Biden’s foreign policy team, urges pressing humanitarian action
November 23, 2020

Press Release
Humanitarian needs in Afghanistan skyrocket amid unrelenting violence and the pandemic; ahead of peace conference, IRC calls on international community to increase funding and push for peace
November 23, 2020

IVAC [to 28 Nov 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

IVI [to 28 Nov 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
IVI, ROK’s GDEF join forces to provide OCV vaccination to 540,000 people at risk of cholera in Nepal and Mozambique
GDEF’s US$8.05 million grant to support ECHO projects to prevent and control cholera and contribute to ‘Ending Cholera—A Global Roadmap to 2030’   The International Vaccine Institute (IVI) and the Republic of Korea’s Global Disease Eradication Fund (GDEF) have agreed to conduct joint projects to […] 11/26/2020

IVI and the Ministry of Foreign Affairs and Human Mobility of Ecuador exchange MOU to pursue global health research & development
November 24, 2020, SEOUL, Republic of Korea — The International Vaccine Institute (IVI) and the Ministry of Foreign Affairs and Human Mobility of Ecuador exchanged a memorandum of understanding (MOU) today at IVI headquarters in Seoul, Republic of Korea to explore areas of collaboration in […]
11/24/2020

LG Electronics, IVI join forces to conduct a ‘cholera vaccination and prevention project’ in Ethiopia
Project to provide vaccination for 40,000 residents in areas at risk of cholera and establish disease monitoring system with the Ethiopian Ministry of Health through the Armauer Hansen Research Institute (AHRI) To contribute to health authorities in policymaking for disease prevention by investigating waterborne diseases […]
11/24/2020

JEE Alliance [to 28 Nov 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

MSF/Médecins Sans Frontières [to 28 Nov 2020]
http://www.msf.org/
Latest [Selected Announcements]
Sudan
MSF providing medical care and assistance in Sudan to people fleein…
Project Update 27 Nov 2020

Iraq
Displaced people in Iraq’s Laylan camp express fears as camp …
Press Release 24 Nov 2020

Coronavirus COVID-19 pandemic
Staff entry restrictions forces MSF to withdraw from COVID-19 response in Venezuela hospital
:: Entry and work permit restrictions for MSF international staff in Venezuela have made it difficult to continue our work on COVID-19.
:: As a result, MSF has been forced to withdraw from the coronavirus COVID-19 response in the Ana Francisca Pérez de León II hospital, Caracas.
:: MSF urges Venezuelan authorities to facilitate the entry of essential international staff into Venezuela to ensure high-level care in the COVID-19 response.

National Vaccine Program Office – U.S. HHS [to 28 Nov 2020]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings
December 4, 2020 NVAC Meeting (Virtual)
[See COVID Vaccines Regulatory Meetings/Milestones above]

NIH [to 28 Nov 2020]
http://www.nih.gov/news-events/news-releases
News Releases
Fourth iteration of COVID-19 treatment trial underway
November 25, 2020 — Study will enroll hospitalized adults with COVID-19 who require supplemental oxygen.

Commonly used antibiotic shows promise for combating Zika infections
November 24, 2020 — NIH preclinical study suggests FDA-approved tetracycline-based antibiotics may slow infection and reduce neurological problems.

PATH [to 28 Nov 2020]
https://www.path.org/media-center/
Press Release
No new digest content identified.

Sabin Vaccine Institute [to 28 Nov 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

UNAIDS [to 28 Nov 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
27 November 2020
Study shows how COVID-19 is impacting access to HIV care in the Russian Federation

25 November 2020
New awareness campaign on gender-based violence in the Middle East and North Africa

24 November 2020
Turning around the HIV response in Odessa

23 November 2020
Condom use declining

UNICEF [to 28 Nov 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Statement
11/25/2020
Threat of further escalation in Mekelle, Ethiopia, puts children’s lives at risk
Statement by UNICEF Executive Director Henrietta Fore

Press release
11/25/2020
320,000 children and adolescents newly infected with HIV in 2019, 1 every 100 seconds – UNICEF
UNICEF warns of COVID-19 disruptions to HIV service delivery in one third of high burden countries

News note
11/23/2020
COVAX Update: UNICEF working with global airlines and freight providers to plan delivery of COVID-19 vaccines
UNICEF kickstarts discussions with over 350 logistics organizations to step up delivery plans for eventual COVID-19 vaccines
[See COVID Logistics above for details]

Statement
11/23/2020
Millions of children’s lives at high risk as Yemen inches towards famine
Statement by UNICEF Executive Director Henrietta Fore

Unitaid [to 28 Nov 2020]
https://unitaid.org/
Featured News
24 November 2020
Unitaid supports ANTICOV, an adaptative platform trial in Africa to treat mild to moderate cases of COVID-19
Geneva –  Unitaid has come together with the German Federal Ministry of Education and Research (BMBF) and the KfW Development Bank to invest in a ground-breaking clinical trial of COVID-19 medicines that are adapted to the needs of low-and middle-income countries.
This innovative trial named ANTICOV will cover 13 countries across Africa and be implemented by a consortium of partners led by Drugs for Neglected Diseases Initiative (DNDi) including 26 African and global research and development organizations.
It seeks to identify treatments that prevent patients with mild to moderate symptoms from progressing to severe disease, thereby reducing transmission of the virus and the need for hospitalisation.
Both outcomes are particularly important in countries with weaker health systems and where quarantine is difficult to implement. Importantly, ANTICOV will look at treatment options for vulnerable people, such as those with coinfections including HIV, TB and malaria.
Most research into COVID-19 medicines is taking place in high-income countries, thereby limiting the development and relevant testing of products adapted to lower-income settings.
Dr. Philippe Duneton, Unitaid’s Executive Director said: “ANTICOV is an important platform to facilitate clinical trials for treatments for COVID-19 in low-resource settings. This is recognised as a key issue by the ACT-A Therapeutics partnership led by Unitaid and Wellcome and will help enable equitable access to medicines against COVID-19 in low- and middle-income countries. Unitaid is pleased to support this important project.”
The trial will evaluate affordable treatments that are already in the market and can be quickly deployed on a large scale. The ultimate goal is to put forward candidate medicines for treatment of mild COVID-19 disease, inform WHO recommendations with conclusive evidence, and support policy change towards test-and-treat strategies for the virus across low- and middle-income countries…

Vaccination Acceptance Research Network (VARN) [to 28 Nov 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

Vaccine Confidence Project [to 28 Nov 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

Vaccine Education Center – Children’s Hospital of Philadelphia [to 28 Nov 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

Wellcome Trust [to 28 Nov 2020]
https://wellcome.ac.uk/news
No new digest content identified.

The Wistar Institute [to 28 Nov 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

WFPHA: World Federation of Public Health Associations [to 28 Nov 2020]
https://www.wfpha.org/
Latest News
Producing a Safe and Effective Vaccine: Align Public Health Needs with Economic & Social Development Objectives
Nov 25, 2020
Producing a Safe and Effective Vaccine: Align Public Health Needs with Economic & Social Development Objectives Webinar recording: https://www.youtube.com/watch?v=nIYiXfI0YIo&t=498s

Sheila Tlou Joins Our International Immunization Policy Task Force!
Nov 24, 2020
Sheila Tlou Joins Our International Immunization Policy Task Force! A warm welcome to Prof. Sheila Dinotshe Tlou Co-Chair of The Global HIV Prevention Coalition & Nursing Now on joining WFPHA’s International Immunization Policy Task Force of key…

World Organisation for Animal Health (OIE) [to 28 Nov 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
No new digest content identified.

::::::

ARM [Alliance for Regenerative Medicine] [to 28 Nov 2020]
https://alliancerm.org/press-releases/
Press Releases
ARM Responds to EU Pharmaceutical Strategy
November 25, 2020 Washington, DC
The EU Pharmaceutical Strategy recognizes cell and gene therapies as ‘major milestones’ of progress in healthcare, which can durably treat or even cure the most challenging diseases. We are reviewing today’s strategy document in detail and believe that innovative regulatory and payment policies are crucial to ensuring patient access to these transformative therapies. We look forward to engaging with the European Commission and other stakeholders to develop a conducive, holistic environment for advanced therapies and the life-changing benefits they bring to patients.

BIO [to 28 Nov 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

DCVMN – Developing Country Vaccine Manufacturers Network [to 28 Nov 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

ICBA – International Council of Biotechnology Associations [to 28 Nov 2020]
https://internationalbiotech.org/news/
News
No new digest content identified.

IFPMA [to 28 Nov 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

PhRMA [to 28 Nov 2020]
http://www.phrma.org/
Selected Press Releases, Statements
PhRMA CAREs Grant request for proposals: Addressing racial disparities in medication utilization and adherence
November 24, 2020
Systemic racism is as real as any disease, and our industry is not immune. This summer, in the wake of a national outcry for racial and social justice, our industry offered a firm stance – systemic racism is a disease. As a pharmacist and public health researcher whose motivation stems from advancing health equity – this statement makes me ponder the question, how can our industry help break the harmful patterns of racial inequities?

Press Release
PhRMA Names Debra DeShong Executive Vice President of Public Affairs
November 23, 2020
The Pharmaceutical Research and Manufacturers of America (PhRMA) today named Debra DeShong as executive vice president of public affairs. DeShong will assume the role in mid-December.

Press Release
Committing to diversity, equity and inclusion: A call to action for clinical trials
November 19, 2020
Guest post from Dr. Barbara Bierer, faculty director of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), a Professor of Medicine, Harvard Medical School and Brigham and Women’s Hospital, Boston and a hematologist/oncologist.
The COVID-19 pandemic is the worst public health emergency the world has encountered in over a century and one that has universally impacted the social, political, economic and medical fabric of our lives; it has also exposed significant and systemic health disparities in health care. The disproportionate rates of infection and of disease-related mortality of people of color have been well-documented. Given these disparities, it is critical that trials for COVID-19 vaccines and therapeutics ensure diverse participation. The few exceptions that have been reported, however, prove that recruitment and retention of underserved populations is possible with effort, planning and intentionality of purpose…
…This week PhRMA published a strong statement embracing equity, denouncing racism and putting forth actionable commitments endorsed by its member companies. PhRMA has expanded its Principles on Conduct of Clinical Trials to emphasize and strengthen the commitment to diverse inclusion in clinical trials. The MRCT Center applauds the seriousness with which the problem of health inequities is being addressed, including the call for investments in workforce development and professional opportunities, in changes in trial design and conduct, in community engagement and partnership, in education and in infrastructure. None of these initiatives will succeed, however, unless we appreciate our interdependencies and common interests. We are all and each responsible and must stand together for change.

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

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 28 Nov 2020)

A simple clinical score to identify likely hepatitis B vaccination non-responders – data from a retrospective single center study
About 10% of Hepatitis B vaccinated individuals mount no protective antibody levels against the hepatitis B surface antigen (HBs-Ag). Older age at primary immunization, obesity and smoking have previously been…
Authors: Marc A. Meier and Christoph T. Berger
Citation: BMC Infectious Diseases 2020 20:891
Content type: Research article
Published on: 25 November 2020

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 28 Nov 2020)

Moral structuring of children during the process of obtaining informed consent in clinical and research settings
Informed consent is an important factor in a child’s moral structure from which different types of doctor–patient relationships arise. Children’s autonomy is currently under discussion in terms of their decent treatment, beyond what doctors and researchers perceive. To describe the influential practices that exist among clinicians and researchers toward children with chronic diseases during the process of obtaining informed consent.
Authors: Anderson Díaz-Pérez, Elkin Navarro Quiroz and Dilia Esther Aparicio Marenco
Content type: Research article
25 November 2020

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 28 Nov 2020)

Predictors of immunization coverage among 12–23 month old children in Ethiopia: systematic review and meta-analysis
Immunization is one of modern medicine’s greatest achievements in the last three decades. Annually it can prevent nearly 2 to 3 million deaths. Understanding the determinants of effective immunization coverage…
Authors: Tahir Yousuf Nour, Alinoor Mohamed Farah, Omer Moelin Ali, Mohamed Omar Osman, Mowlid Akil Aden and Kalkidan Hassen Abate
Citation: BMC Public Health 2020 20:1803
Content type: Research article
Published on: 26 November 2020

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 28 Nov 2020)

Willingness of female sex workers in Kampala, Uganda to participate in future HIV vaccine trials: a case control study
We anticipate large efficacy trials of novel HIV vaccines that have shown acceptable safety profiles. We determined willingness to participate (WTP) in future HIV vaccine efficacy trials among HIV negative fem…
Authors: Yunia Mayanja, Andrew Abaasa, Gertrude Namale, Matt A. Price and Anatoli Kamali
Citation: BMC Public Health 2020 20:1789
Content type: Research article
Published on: 25 November 2020

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 28 Nov 2020)

The role of the media on maternal confidence in provider HPV recommendation
Despite a growing understanding of the importance of provider HPV recommendation on parental acceptance, U.S. HPV vaccination rates remain suboptimal. Given the prevalence and use of the media for health decis…
Authors: Kimberly K. Walker, Heather Owens and Gregory Zimet
Citation: BMC Public Health 2020 20:1765
Content type: Research article
Published on: 23 November 2020

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 28 Nov 2020)

Personality and individual attitudes toward vaccination: a nationally representative survey in the United States
Although past studies have identified factors associated with individual perceptions of vaccination, limited attention has been paid to the role of personality in individual attitudes toward vaccination. This
Authors: Fang-Yu Lin and Ching-Hsing Wang
Citation: BMC Public Health 2020 20:1759
Content type: Research article
Published on: 23 November 2020

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 28 Nov 2020)

Geographic location of health facility and immunization program performance in Hoima district, western Uganda: a health facility level assessment
Globally, immunization coverage for childhood vaccines is below the immunization target of achieving at least 90% coverage with the pentavalent vaccine. In Uganda, a recent survey shows 80% of districts had po…
Authors: Nicholas Kwikiriza Magambo, Francis Bajunirwe and Fred Bagenda
Citation: BMC Public Health 2020 20:1764
Content type: Research article
Published on: 23 November 2020

Conflict and Health
http://www.conflictandhealth.com/
[Accessed 28 Nov 2020]

Considerations for planning COVID-19 treatment services in humanitarian responses
The COVID-19 pandemic has the potential to cause high morbidity and mortality in crisis-affected populations. Delivering COVID-19 treatment services in crisis settings will likely entail complex trade-offs bet…
Authors: Sylvia Garry, Nada Abdelmagid, Louisa Baxter, Natalie Roberts, Olivier le Polain de Waroux, Sharif Ismail, Ruwan Ratnayake, Caroline Favas, Elizabeth Lewis and Francesco Checchi
Citation: Conflict and Health 2020 14:80
Content type: Research in practice
Published on: 25 November 2020

Gates Open Research
https://gatesopenresearch.org/browse/articles
[Accessed 28 Nov 2020]

Research Article metrics AWAITING PEER REVIEW
Ripple effects of research capacity strengthening: a study of the effects of a project to support test facilities in three African countries towards Good Laboratory Practice certification [version 1; peer review: awaiting peer review]
Sara Begg, Alexandra Wright, Graham Small, Diabate Abdoulaye, William Kisinza, Benjamin Koudou, Sarah Moore, Franklin Mosha, Constant Edi, Matthew Kirby, Patrick Kija, Robert Malima, Jason Moore, Imelda Bates
Peer Reviewers Invited
Funder
Bill and Melinda Gates Foundation
PUBLISHED 27 Nov 2020

Health Policy and Planning
Volume 35, Issue Supplement_1, November 2020
https://academic.oup.com/heapol/issue/35/Supplement_1

SUPPLEMENT
Health policy and systems research mentoring: Supporting early career women in Low- and Middle-Income Countries
Supporting early-career mentorship for women in Health Policy and Systems Research: a vital input to building the field
Aku Kwamie, Nanuka Jalaghonia
Health Policy and Planning, Volume 35, Issue Supplement_1, November 2020, Pages i4–i6, https://doi.org/10.1093/heapol/czaa105

Health Policy and Planning
Volume 35, Issue Supplement_1, November 2020
https://academic.oup.com/heapol/issue/35/Supplement_1

Factors associated with the utilization of inactivated polio vaccine among children aged 12 to 23 months in Kalungu District, Uganda
Mirembe Rachel Faith, Babirye Juliet, Nathan Tumuhamye, Tumwebaze Mathias, Emma Sacks
Health Policy and Planning, Volume 35, Issue Supplement_1, November 2020, Pages i30–i37, https://doi.org/10.1093/heapol/czaa099

Health Policy and Planning
Volume 35, Issue Supplement_1, November 2020
https://academic.oup.com/heapol/issue/35/Supplement_1

Do social accountability approaches work? A review of the literature from selected low- and middle-income countries in the WHO South-East Asia region
Nahitun Naher, Dina Balabanova, Eleanor Hutchinson, Robert Marten, Roksana Hoque …
Health Policy and Planning, Volume 35, Issue Supplement_1, November 2020, Pages i76–i96, https://doi.org/10.1093/heapol/czaa107

Humanitarian Exchange Magazine
Number 78, October 2020
https://odihpn.org/magazine/inclusion-of-persons-with-disabilities-in-humanitarian-action-what-now/

Disability inclusion in humanitarian action
by HPN October 2020
The theme of this edition of Humanitarian Exchange, co-edited with Sherin Alsheikh Ahmed from Islamic Relief Worldwide, is disability inclusion in humanitarian action. Persons with disabilities are not only disproportionately impacted by conflicts, disasters and other emergencies, but also face barriers to accessing humanitarian assistance. At the same time, global commitments and standards and the IASC Guidelines on the inclusion of persons with disabilities in humanitarian action all emphasise how persons with disabilities are also active agents of change. Disability and age-focused organisations have led on testing and demonstrating how inclusion can be done better. Yet despite this progress, challenges to effective inclusion remain.

As Kirstin Lange notes in the lead article, chief among these challenges is humanitarian agencies’ lack of engagement with organisations of persons with disabilities. Simione Bula, Elizabeth Morgan and Teresa Thomson look at disability inclusion in humanitarian response in the Pacific, and Kathy Al Jubeh and Alradi Abdalla argue for a ‘participation revolution’, building on learning from the gender movement. Tchaurea Fleury and Sulayman AbdulMumuni Ujah outline how the Bridge Article 11 training initiative is encouraging constructive exchange between humanitarian and disability actors. The lack of good, disaggregated data is highlighted by Sarah Collinson; Frances Hill, Jim Cranshaw and Carys Hughes emphasise the need for training resources in local languages and accessible formats; and Sophie Van Eetvelt and colleagues report on a review of the evidence on inclusion of people with disabilities and older people.

Rebecca Molyneux and co-authors analyse the findings of a review of a DFID programme in north-east Nigeria, while Carolin Funke highlights the importance of strategic partnerships between disability-focused organisations, drawing on her research in Cox’s Bazar. Sherin Alsheikh Ahmed describes Islamic Relief Worldwide’s approach to mainstreaming protection and inclusion, while Pauline Thivillier and Valentina Shafina outline IRC’s Client Responsive Programming. The edition ends with reflections by Mirela Turcanu and Yves Ngunzi Kahashi on CAFOD’s SADI approach.

International Journal of Infectious Diseases
November 2020 Volume 100 p1-512
https://www.ijidonline.com/current

Original Reports
Characterizing mothers and children at risk of being under-immunized in India: A latent class analysis approach
Taylor A. Holroyd, Brian Wahl, Madhu Gupta,…Daniel J. Erchick, Mathuram Santosham,
Rupali J. Limaye
Published online: August 26, 2020
p59-66

JAMA
November 24, 2020, Vol 324, No. 20, Pages 2013-2114
https://jamanetwork.com/journals/jama/currentissue

Research Letter
COVID-19 and Excess All-Cause Mortality in the US and 18 Comparison Countries
Alyssa Bilinski, MSc; Ezekiel J. Emanuel, MD, PhD
free access has active quiz
JAMA. 2020;324(20):2100-2102. doi:10.1001/jama.2020.20717
This Viewpoint compares the COVID-19 per capita overall and excess mortality rates in the US vs that of 18 OECD countries and the timing of any increases in excess mortality between February and September 2020.

JAMA
November 24, 2020, Vol 324, No. 20, Pages 2013-2114
https://jamanetwork.com/journals/jama/currentissue

Viewpoint
Is It Lawful and Ethical to Prioritize Racial Minorities for COVID-19 Vaccines?
Harald Schmidt, PhD; Lawrence O. Gostin, JD; Michelle A. Williams, ScD
free access has active quiz has multimedia has audio
JAMA. 2020;324(20):2023-2024. doi:10.1001/jama.2020.20571
This Viewpoint considers how COVID-19 vaccines can be distributed strategically, ethically, and legally given conflicts between consensus public health recommendations to prioritize allocation to disadvantaged racial and ethnic minorities and laws discouraging explicit consideration of race in policy decisions.

JAMA
November 24, 2020, Vol 324, No. 20, Pages 2013-2114
https://jamanetwork.com/journals/jama/currentissue

Scientific and Ethical Principles Underlying Recommendations From the Advisory Committee on Immunization Practices for COVID-19 Vaccination Implementation
Beth P. Bell, MD, MPH; José R. Romero, MD; Grace M. Lee, MD, MPH
free access has active quiz
JAMA. 2020;324(20):2025-2026. doi:10.1001/jama.2020.20847
This Viewpoint summarizes the principles guiding coronavirus disease 2019 (COVID-19) vaccine recommendations made by the Advisory Committee on Immunization Practices (ACIP), a nongovernment advisory standing committee that counsels the Centers for Disease Control and Prevention on US population vaccine use, emphasizing that any final recommendations await phase 3 safety and efficacy data from ongoing trials.

JAMA
November 24, 2020, Vol 324, No. 20, Pages 2013-2114
https://jamanetwork.com/journals/jama/currentissue

Answering Key Questions About COVID-19 Vaccines
Jesse L. Goodman, MD, MPH; John D. Grabenstein, RPh, PhD; M. Miles Braun, MD, MPH
free access has active quiz
JAMA. 2020;324(20):2027-2028. doi:10.1001/jama.2020.20590
This Viewpoint offers provisional answers to common questions the public will have about approved COVID-19 vaccines, including what they can expect regarding its effectiveness and safety, trustworthiness of the approval process, and whether society can return to normal once sufficient numbers of people are immunized.

JAMA
November 24, 2020, Vol 324, No. 20, Pages 2013-2114
https://jamanetwork.com/journals/jama/currentissue

Herd Immunity and Implications for SARS-CoV-2 Control
Saad B. Omer, MBBS, MPH, PhD; Inci Yildirim, MD, PhD, MSc; Howard P. Forman, MD, MBA
free access has active quiz has multimedia has audio
JAMA. 2020;324(20):2095-2096. doi:10.1001/jama.2020.20892
This JAMA Insights Clinical Update discusses herd immunity in the context of the COVID-19 pandemic and explains the herd immunity threshold as a function of transmissibility (R0), the role of an effective vaccine and vaccination program in sustaining herd immunity, and the risks of an infection-based herd immunity approach.

Journal of Evidence-Based Medicine
Volume 13, Issue 4 Pages: 251-324 November 2020
https://onlinelibrary.wiley.com/toc/17565391/current

EDITORIAL
Evidence synthesis and methodological research on evidence in medicine—Why it really is research and it really is medicine
Livia Puljak
Pages: 253-254
First Published: 03 November 2020

Journal of Evidence-Based Medicine
Volume 13, Issue 4 Pages: 251-324 November 2020
https://onlinelibrary.wiley.com/toc/17565391/current

REVIEWS
Analytics with artificial intelligence to advance the treatment of acute respiratory distress syndrome
Zhongheng Zhang et al
Pages: 301-312
First Published: 13 November 2020
Abstract
Artificial intelligence (AI) has found its way into clinical studies in the era of big data. Acute respiratory distress syndrome (ARDS) or acute lung injury (ALI) is a clinical syndrome that encompasses a heterogeneous population. Management of such heterogeneous patient population is a big challenge for clinicians. With accumulating ALI datasets being publicly available, more knowledge could be discovered with sophisticated analytics. We reviewed literatures with big data analytics to understand the role of AI for improving the caring of patients with ALI/ARDS. Many studies have utilized the electronic medical records (EMR) data for the identification and prognostication of ARDS patients. As increasing number of ARDS clinical trials data is open to public, secondary analysis on these combined datasets provide a powerful way of finding solution to clinical questions with a new perspective. AI techniques such as Classification and Regression Tree (CART) and artificial neural networks (ANN) have also been successfully used in the investigation of ARDS problems. Individualized treatment of ARDS could be implemented with a support from AI as we are now able to classify ARDS into many subphenotypes by unsupervised machine learning algorithms. Interestingly, these subphenotypes show different responses to a certain intervention. However, current analytics involving ARDS have not fully incorporated information from omics such as transcriptome, proteomics, daily activities and environmental conditions. AI technology is assisting us to interpret complex data of ARDS patients and enable us to further improve the management of ARDS patients in future with individual treatment plans.

The Lancet
Nov 28, 2020 Volume 396 Number 10264 p1703-1776
https://www.thelancet.com/journals/lancet/issue/current

Editorial
Maintaining the HIV response in a world shaped by COVID-19
The Lancet

The Lancet
Nov 28, 2020 Volume 396 Number 10264 p1703-1776
https://www.thelancet.com/journals/lancet/issue/current

Comment
Emergency use authorisation for COVID-19 vaccines: lessons from Ebola
Maxwell J Smith, Samuel Ujewe, Rachel Katz, Ross E G Upshur
Russia and China have begun COVID-19 vaccinations outside of clinical trials. This move has been met with widespread criticism because the safety profiles of these candidate COVID-19 vaccines remain uncertain without data from phase 3 trials.^1,2 Emergency use authorisations—a regulatory mechanism that enables the public to gain access to promising investigational medical products when those products have not yet received regulatory approval and licensure³ —have previously been used for unlicensed vaccines in public health emergencies and can be ethically justified provided that certain conditions are met. So why have the actions of Russia and China drawn such criticism? And how can other national regulatory authorities ensure future emergency use authorisations for COVID-19 vaccines are issued in a way that is scientifically and ethically sound? Experience of emergency use authorisations for investigational Ebola virus vaccines in Guinea and the Democratic Republic of the Congo (DRC) can elucidate key lessons that can guide ethical emergency use authorisations for COVID-19 vaccines…

Nature
Volume 587 Issue 7835, 26 November 2020
http://www.nature.com/nature/current_issue.html

Editorial | 25 November 2020
UNESCO must reform to stay relevant — and reconnect people through science
At 75, the UN agency with a focus on science cooperation is fighting for its future role.

Nature
Volume 587 Issue 7835, 26 November 2020
http://www.nature.com/nature/current_issue.html

Editorial | 24 November 2020
The COVID vaccine challenges that lie ahead
As positive results emerge at last, researchers must help the world to address vaccine hesitancy, supply logistics and pricing.

New England Journal of Medicine
November 26, 2020 Vol. 383 No. 22
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Banning Genetic Discrimination in Life Insurance — Time to Follow Florida’s Lead
Mark A. Rothstein, J.D.,
and Kyle B. Brothers, M.D., Ph.D.
Fear of discrimination by life insurance companies has been an obstacle to progress in the use of genetic technologies in medicine and research. A new Florida law will allow residents to undergo genetic testing without fear of the financial consequences of results.

New England Journal of Medicine
November 26, 2020 Vol. 383 No. 22
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Trustworthiness before Trust — Covid-19 Vaccine Trials and the Black Community
Rueben C. Warren, D.D.S., Dr.P.H., M.Div., Lachlan Forrow, M.D., David Augustin Hodge, Sr., D.Min., Ph.D., and Robert D. Truog, M.D.
… What are the barriers to greater participation of Black people in Covid-19 trials? Although they are multiple, a critical factor is the deep and justified lack of trust that many Black Americans have for the health care system in general and clinical research in particular. This distrust is often traced to the legacy of the infamous syphilis study at Tuskegee, in which investigators withheld treatment from hundreds of Black men in order to study the natural history of the disease. But the distrust is far more deeply rooted, in centuries of well-documented examples of racist exploitation by American physicians and researchers.²

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

Research Article
Hepatitis B vaccination status and knowledge, attitude, and practice regarding Hepatitis B among preclinical medical students of a medical college in Nepal
Dhan Bahadur Shrestha, Manita Khadka, Manoj Khadka, Prarthana Subedi, Subashchandra Pokharel, Bikash Bikram Thapa
Research Article | published 23 Nov 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0242658

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

Articles
Ethics in field experimentation: A call to establish new standards to protect the public from unwanted manipulation and real harms
Rose McDermott and Peter K. Hatemi
PNAS first published November 23, 2020. https://doi.org/10.1073/pnas.2012021117
Abstract
In 1966, Henry Beecher published his foundational paper “Ethics and Clinical Research,” bringing to light unethical experiments that were routinely being conducted by leading universities and government agencies. A common theme was the lack of voluntary consent. Research regulations surrounding laboratory experiments flourished after his work. More than half a century later, we seek to follow in his footsteps and identify a new domain of risk to the public: certain types of field experiments. The nature of experimental research has changed greatly since the Belmont Report. Due in part to technological advances including social media, experimenters now target and affect whole societies, releasing interventions into a living public, often without sufficient review or controls. A large number of social science field experiments do not reflect compliance with current ethical and legal requirements that govern research with human participants. Real-world interventions are being conducted without consent or notice to the public they affect. Follow-ups and debriefing are routinely not being undertaken with the populations that experimenters injure. Importantly, even when ethical research guidelines are followed, researchers are following principles developed for experiments in controlled settings, with little assessment or protection for the wider societies within which individuals are embedded. We strive to improve the ethics of future work by advocating the creation of new norms, illustrating classes of field experiments where scholars do not appear to have recognized the ways such research circumvents ethical standards by putting people, including those outside the manipulated group, into harm’s way.

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

The science of deep learning
Richard Baraniuk, David Donoho, and Matan Gavish
PNAS first published November 23, 2020.
https://doi.org/10.1073/pnas.2020596117

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
https://www.paho.org/journal/en

Latest articles
23 Nov 2020
Open public health: the way not to leave anyone behind
Opinion and analysis | Spanish |

Vaccine
Volume 38, Issue 51 Pages 8055-8246 (3 December 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/51

Discussion No access
Vaccine mandates in the US and Australia: balancing benefits and burdens for children and physicians
Mark C. Navin, Margie Danchin
Pages 8075-8077

Vaccine
Volume 38, Issue 51 Pages 8055-8246 (3 December 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/51

Research article Full text access
The demand for a COVID-19 vaccine in Ecuador
Oscar Sarasty, Carlos E. Carpio, Darren Hudson, Patricia A. Guerrero-Ochoa, Ivan Borja
Pages 8090-8098

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 28 Nov 2020)

Open Access Article
The Magnitude and Determinants of Missed Opportunities for Childhood Vaccination in South Africa
by Duduzile Ndwandwe et al
Vaccines 2020, 8(4), 705; https://doi.org/10.3390/vaccines8040705 – 25 Nov 2020
Viewed by 160
Abstract
Missed opportunities for vaccination (MOV) may be among the factors responsible for suboptimal vaccination coverage in South Africa. However, the magnitude and determinants of MOV in the country are not known. Thus, this study seeks to assess the prevalence and determinants of MOV […]

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

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 28 Nov 2020
Ideas
Your Individually Rational Choice Is Collectively Disastrous
Stopping the virus from spreading requires us to override our basic intuitions.
November 24, 2020
Yascha Mounk
.. Many factors help explain America’s abject failure to contain the pandemic. A good number of them can be traced back to Donald Trump. But many democracies with able leaders, such as Germany and Canada, are also struggling to contain the virus, so pointing to the president’s lies and incompetence isn’t sufficient.
One major problem is that stopping the virus from spreading requires us to override our basic intuitions. Three cognitive biases make it hard for us to avoid actions that put us in great collective danger…

BBC
http://www.bbc.co.uk/
Accessed 28 Nov 2020
[No new, unique, relevant content]

The Economist
http://www.economist.com/
Accessed 28 Nov 2020
United States Nov 28th 2020 edition
America will be the first country to roll out a covid-19 vaccine
Here is how the federal government and states plan to do it

Financial Times
https://www.ft.com/
Accessed 28 Nov 2020
Coronavirus treatment
UK set to approve Pfizer-BioNTech Covid vaccine within days
…The UK is poised to become the first western country to approve a Covid-19 vaccine, with the independent regulator set to grant approval within days. Deliveries of the vaccine developed by BioNTech…
November 28, 2020

Analysis Pharmaceuticals sector
Covid vaccines offer Big Pharma a chance of rehabilitation
November 27, 2020

Analysis Coronavirus treatment
How AstraZeneca and Oxford found their vaccine under fire
ovember 27, 2020

Forbes
http://www.forbes.com/
Accessed 28 Nov 2020
Breaking  |  5 hours ago
Biden Creates Diverse Covid-19 Advisory Board To Contrast With Trump
Trump’s task force is primarily composed of political appointees with portfolios ranging from the economy to national security to housing.
By Andrew Solender Forbes Staff

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 28 Nov 2020
[No new, unique, relevant content]

Foreign Policy
http://foreignpolicy.com/
Accessed 28 Nov 2020
[No new, unique, relevant content]

The Guardian
http://www.guardiannews.com/
Accessed 28 Nov 2020
[No new, unique, relevant content]

New Yorker
http://www.newyorker.com/
Accessed 28 Nov 2020
[No new, unique, relevant content]

New York Times
http://www.nytimes.com/
Accessed 28 Nov 2020
Europe
Britain Set to Leap Ahead in Approving Vaccines
Regulators may approve the troubled AstraZeneca vaccine and the American-made Pfizer shot weeks before the U.S. does so.
By Benjamin Mueller Nov. 27

World
The military’s role in a vaccine will be strictly behind the scenes, despite Trump’s claims.
By Jennifer Steinhauer Nov. 27

Science
The Virus Won’t Stop Evolving When the Vaccine Arrives
The coronavirus is not a shape shifter like the flu virus, but it could become vaccine resistant over time. That prompts researchers to urge vigilance.
By James Gorman and Carl Zimmer Nov. 27

Business
After Admitting Mistake, AstraZeneca Faces Difficult Questions About Its Vaccine
Some trial participants only got a partial dose of AstraZeneca’s vaccine. Experts said the company’s spotty disclosures have eroded confidence.
By Rebecca Robbins and Benjamin Mueller Nov. 25

World
A Russian vaccine maker reports positive results based on an incomplete trial.
The results were based on an unspecified small group of volunteers during the ongoing Phase 3 trial of the vaccine.
By Andrew E. Kramer

Washington Post
https://www.washingtonpost.com/
Opinion by Editorial Board
The U.S. has ensured its supplies of coronavirus vaccine. Now it must help provide them to poor
Nov 26, 2020
THE WORLD HEALTH Organization’s director-general, Dr. Tedros Adhanom Ghebreyesus, warned in August that no country could afford to go it alone in fighting the pandemic. Nations already depend on global supply chains for everything from diagnostic testing to personal protective equipment, he said, and they must avoid “vaccine nationalism” when it comes to the most powerful tool to fight covid-19. When the Group of 20 leaders held their virtual summit meeting last weekend, they again declared their intent not to hoard lifesaving vaccines, saying, “We will spare no effort to ensure their affordable and equitable access for all people.”

But as vaccines come closer to reality, wealthy nations of the world have already taken care of their own needs and signed contracts to buy up hundreds of millions of vaccine doses. And the poor? A global risk-sharing procurement initiative to ensure fair and equitable access to vaccines, the Covax Facility, could bring them protection, but only if it can get sufficient funding in 2021. This is the world’s best chance to help the poorest populations confront the pandemic, being led by the WHO, the Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance.

As it currently stands, 92 lower-income economies will be supported by the financing mechanism in Covax, the Advanced Market Commitment (AMC). Ninety-seven higher-income economies have signed up as self-financing members of the Covax Facility. The idea is to pool vaccine buying power and ensure distribution for all countries, including the less developed nations, with a goal of obtaining 2 billion doses to protect 20 percent of their populations by the end of 2021, enough to cover front-line health-care workers and the most vulnerable. Negotiations for the shots are underway with manufacturers. To make this initiative work, according to the WHO, there is an urgent need for $7.8 billion next year from international donors, including $5 billion for the 92 lower-income countries, and additional funds to help them set up distribution systems, a demanding task. All of that funding remains to be raised.

China and Russia are developing vaccines, too. They have their own national regulatory process, but for their vaccines to be used globally through the Covax Facility they would have to meet international standards through WHO review of quality, safety and impact on disease. They could distribute the vaccines on their own. China has joined Covax as a participant, allowing it to procure doses from the facility, but Russia has not.

Among the big donors to the AMC are the United Kingdom, Canada, Germany and Saudi Arabia. President-elect Joe Biden should commit the United States, too. A $200 million donation would amount to only 2 percent of spending on Operation Warp Speed. And we hope Mr. Biden will rapidly return the United States to the WHO.

The world’s wealthiest countries are on the verge of a science triumph with the arrival of an effective vaccine in less than a year. But in this moment of need, the haves should also extend a hand to the have-nots. As Dr. Tedros said in August, “No one is safe until everyone is safe.”

EU says first virus vaccinations possible by Christmas
Associated Press · Nov 25, 2020