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

Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – 5 January 2021

5 January 2021 10:00 – 17:00 CET

This extraordinary virtual meeting for the Strategic Advisory Group of Experts on Immunization (SAGE) will be held on Tuesday 05 January 2021 to propose recommendations to WHO on the use of COVID-19 vaccine(s).

Meeting materials

Materials for this meeting such as a provisional list of participants and background documents will be made available nearer the time.

Draft Meeting Agenda  [see image below]

Draft Summary of Declaration of Interests

Background documents for the Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – 5 January 2021

:: mRNA vaccines against COVID-19: Pfizer-BioNTech COVID-19 vaccineBNT162b2

   Draft document – Prepared by the Strategic Advisory Group of Experts (SAGE) on Immunization Working Group on COVID-19 vaccines

22 December 2020  | Technical document

WHO Reference Number: WHO/2019-nCoV/vaccines/SAGE_evaluation/BNT162b2/2020.1

Download

:: Background paper on Covid-19 disease and vaccines

   Draft document – Prepared by the Strategic Advisory Group of Experts (SAGE) on Immunization Working Group on COVID-19 vaccines

22 December 2020  | Technical document

WHO Reference Number: WHO/2019-nCoV/vaccines/SAGE_background/2020.1

Download

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WHO – Planned COVID-19 Vaccine Effectiveness and Impact Studies: Request for Information

22 December 2020 

Call for submissions

   After COVID-19 vaccines are introduced into countries, it will be vital to generate real-world data on vaccine effectiveness and vaccine impact, as many questions will remain unanswered by the clinical trials.   Studies will likely be done in a variety of countries, in a variety of populations, and using a variety of study designs.  

   As part of our scoping of the landscape to understand the future availability of data to inform global policy and the gaps that need to be filled, we invite researchers to provide information about their planned work on COVID-19 vaccination effectiveness and/or impact studies.  This can be done by filling out this electronic form with relevant details. This form will take less than 5 minutes  of your time.

   Data provided will be used by the Strategic Advisory Group of Experts on Immunization to understand what data will be available and when it will be available  to update their global policy recommendations. 

   Initial responses are requested as soon as possible. This will be an ongoing process, where updates can be provided in the future as plans change or studies are implemented.  

   Basic information such as country of study or study design will be made available through the WHO website to highlight the landscape of studies being undertaken. 

   Please provide preliminary responses by January 15, 2021. Future requests for information will be posted as we know plans are fluid. 

   Questions can be addressed to covidve@who.int

Milestones :: Perspectives :: Research

COVID Vaccines: Development/Regulatory Actions/Procurement/Deployment

Pfizer and BioNTech to Supply the U.S. with 100 Million Additional Doses of COVID-19 Vaccine
December 23, 2020
:: U.S. government orders 100 million additional doses of the Pfizer-BioNTech COVID-19 Vaccine bringing total doses for U.S. to 200 million
:: All 200 million doses expected to be delivered by July 31, 2021, allowing for 100 million people in the U.S. to be vaccinated

Serum Institute Of India And Dynavax Announce First Participants Dosed In The Phase 1/2 Clinical Trial For A COVID-19 Vaccine
PUNE, India and EMERYVILLE, Calif., Dec. 23, 2020 /PRNewswire/ — Further strengthening its fight against COVID-19, Serum Institute of India (SIIPL), the world’s largest vaccine manufacturer by volume, has partnered with Dynavax Technologies Corporation (Nasdaq: DVAX) a biopharmaceutical company focused on developing and commercializing novel vaccines, and today jointly announced that the first participants have been dosed in the Phase 1 part of the Phase 1/2 clinical trial evaluating SIIPL’s vaccine candidate adjuvanted with CpG 1018 to prevent COVID-19.
The Phase 1/2 clinical trial will evaluate the safety and immunogenicity of SIIPL’s vaccine candidate consisting of the SARS-COV-2 virus receptor binding domain (RBD) delivered as a virus-like particle (VPL), along with Dynavax’s advanced adjuvant CpG 1018 plus alum. The Phase 1 portion of the clinical trial will enroll 39 healthy volunteers and post the completion of the study a decision will be taken regarding the dosing of up to 216 subjects in Phase 2…

EMA recommends first COVID-19 vaccine for authorisation in the EU (updated)
CHMP December 22, 2020
EMA has recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. EMA’s scientific opinion paves the way for the first marketing authorisation of a COVID-19 vaccine in the EU by the European Commission, with all the safeguards, controls and obligations this entails.

EMA’s human medicines committee (CHMP) has completed its rigorous evaluation of Comirnaty, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation. This will provide a controlled and robust framework to underpin EU-wide vaccination campaigns and protect EU citizens.

“Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many,” said Emer Cooke, Executive Director of EMA. “We have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU Member States.

“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards. However, our work does not stop here. We will continue to collect and analyse data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU.”…

Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine
:: COMIRNATY® (also known as BNT162b2) receives conditional marketing authorization from the European Commission; this milestone represents a global joint effort to advance the first authorized mRNA vaccine
:: Pfizer and BioNTech are ready to immediately ship initial doses to the 27 EU member states
Pfizer and BioNTech previously announced an agreement with the European Commission to supply 200 million vaccine doses to EU member states; the EU also has an option to purchase an additional 100 million doses in 2021
:: The vaccine has now been granted a conditional marketing authorization, emergency use authorization, or temporary authorization in more than 40 countries worldwide, including all 27 EU member states
December 21, 2020 NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the European Commission (EC) has granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for COMIRNATY® (also known as BNT162b2), for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine earlier today. The EC granted this CMA in the interest of public health to help address the COVID-19 pandemic. The CMA is valid in all 27 member states of the European Union (EU)…

RDIF, The Gamaleya National Center, AstraZeneca and R-Pharm sign an agreement to cooperate on COVID-19 vaccine development
MOSCOW, Dec. 21, 2020 /PRNewswire/ — The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), The Gamaleya National Center, AstraZeneca and R-Pharm have signed an agreement aimed at the development and implementation of a clinical research program to assess the immunogenicity and safety of the combined use of one of the components of the Sputnik V vaccine developed by the Gamaleya Center, and one of the components of the AZD1222 vaccine, developed by AstraZeneca and the University of Oxford.
The agreement was announced on a video-conference with Vladimir Putin, the President of Russia.
The parties have also agreed to develop scientific and business relations and explore the possibilities for joint use of the Sputnik V vaccine and the AZD1222 vaccine in order to create more effective and long-term immunization against potential new coronavirus infections.
Clinical trials of the combination of AZD1222 vaccine with Sputnik V’s human adenoviral vector type Ad26 will begin soon. R-Pharm will be among the organizations funding the trial…

Milestones :: Perspectives :: Research

COVID Vaccines Development/Procurement/Distribution/Policy – Russia, China

Sputnik V – “the first registered COVID-19 vaccine” [to 26 Dec 2020]
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
First batch of 300,000 doses of Sputnik V vaccine delivered to Argentina
Press release, 24.12.2020

Argentina has registered the Sputnik V vaccine based on Russian clinical trial data
Press release, 23.12.2020
…Argentina was the first country in Latin America to officially register Sputnik V. The vaccine was registered under the emergency use authorization procedure and was approved by the regulator, ANMAT [National Administration of Drugs, Foods and Medical Devices of Argentina] based on the results of Phase III clinical trials in Russia, without additional trials in Argentina…

Production of Russian Sputnik V vaccine against coronavirus launched in Kazakhstan
Press release, 21.12.2020

Belarus becomes the first foreign country to register the Sputnik V vaccine
Press release, 21.12.2020

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CHINA

National Medical Products Administration [to 26 Dec 2020]
http://english.nmpa.gov.cn/news.html
News
News
Official: Vaccines good for at least 6 months
2020-12-24
The COVID-19 vaccine’s protection can last for more than half a year at least, said Zeng Yixin, deputy head of the National Health Commission, at news conference in Beijing on Dec 19.
He said the estimate is based on follow-up visits to No 3 People’s Hospital of Shenzhen, Guangdong province.
Six months after their recovery, 96 percent of people who had been infected with the novel coronavirus still had antibodies to protect them against new infections, the hospital said.
The follow-ups involved 506 people who had recovered from the infection between January and May.
The longest duration of for positive antibodies in this group was more than 10 months, the hospital said.
The purpose of the follow-up visits was to get an idea of how long the COVID-19 vaccines would provide protection, and to offer reference points in large-scale inoculation plans.
Zeng said there is no doubt that the protection the vaccines can provide is longer than half a year, as stipulated by the World Health Organization.
Even so, he said, it is still too early to say that the vaccines can realize lifetime protection, or provide five to 10 years’ protection.
Follow-up visits to the hospital will last for five years.

Official affirms safety of Chinese vaccines
Respecting laws of science fundamental principle in its development, he says
2020-12-22
Experimental COVID-19 vaccines developed by Chinese researchers are safe, and ongoing efforts to push for their market approval will strictly follow the rules of science, a health official said on Dec 21.
China is conducting third-stage clinical trials for five Chinese-made vaccine candidates overseas and has administered emergency inoculations to nearly 1 million people in the country, according to Zheng Zhongwei, an official with the National Health Commission who is leading the task force on vaccine development.
“These vaccinations have fully demonstrated the safety of Chinese-made vaccines. There is some adverse reaction, but no severe adverse effect has been reported,” he said during a news conference on Monday.
He added that results from third-stage human trials are needed to determine the efficacy of these vaccines, although data from earlier phases of clinical trials and reports from recipients of emergency inoculations in high-risk countries have already shown the protective effects of these doses.
“Some leading developers have just obtained enough cases to conduct analysis of its efficacy. They have begun to submit materials needed for approval to the National Medical Products Administration,” Zheng said.
Market approval will only be granted after submitted trial findings meet the requirements of the top drug regulator, he added.
Zheng stressed that throughout the vaccine development process in China, respecting the laws of science has always been the fundamental principle…

China starts building COVID-19 vaccine production facility
2020-12-22
China started the construction of a plant for manufacturing an mRNA-based COVID-19 vaccine on Dec 21, with production operations due to begin in eight months, according to local authorities.

EMERGENCIES

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

Weekly Epidemiological and Operational updates
Last update: 5 December 2020, 9:02 am GMT-5
Confirmed cases :: 78 604 532 [week ago: 74 299 042] [two weeks ago: 69 808 588]
Confirmed deaths :: 1 744 235 [week ago: 1 669 982] [two weeks ago: 1 588 854]
Countries, areas or territories with cases :: 222

::::::

22 December 2020
Weekly epidemiological update – 22 December 2020
Overview
Globally in the past week, new COVID-19 cases and deaths continued to increase to approximately 4.6 million new cases and over 79 000 new deaths. This brings the cumulative numbers to over 75 million reported cases and 1.6 million deaths globally since the start of the pandemic.

21 December 2020
WHO – Weekly operational update on COVID-19 – 21 December 2020
[Excerpt]
Partnerships
The Global Health Cluster -GHC
The Global Health Cluster released three new GHC COVID-19TaskTeam tools and guidance to support COVID-19 response operations in humanitarian settings:
:: Ethics: key questions to ask when facing dilemmas during COVID-19 in humanitarian settings
:: Essential Health Services: A guidance note How to prioritize and plan essential health services during COVID-19 response in humanitarian settings
:: Health workforce estimator tool to estimate workforce as relevant in humanitarian settings

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Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 23 December 2020
:: The19th report of the Independent Monitoring Board (IMB) has been published. The IMB notes the strong resumption of polio campaigns following the temporary pause due to COVID-19 and commends the programme for supporting COVID-19 response efforts. The IMB points to several pivotal challenges which the programme must tackle with urgency to achieve success and offers a set of 17 key recommendations to capitalise on the momentum of resumed immunizations.

:: The GPEI has published a global cVDPV resource document aimed at providing a high-level overview of cVDPVs, their importance to the programme and strategy for responding to them, including nOPV2. Available here in various languages, this resource can be used at global, regional and country levels, for high-level advocacy with government counterparts, internal staff, donors or other partners, as appropriate.

:: On a wintery November day, vaccinators across Afghanistan wrapped up warm, checked that they had facemasks and hand sanitizer, and headed out into the cold morning. Their mission? To reach 9.9 million children with polio vaccines, before snowfall blocked their way. Read more

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
:: Afghanistan: two WPV1 and 23 cVDPV2 positive environmental samples
:: Pakistan: one WPV1 and 11 cVDPV2 cases
:: Benin: one cVDPV2 positive environmental sample
:: Burkina Faso: six cVDPV2 cases
:: Chad: two cVDPV2 cases
:: South Sudan: 10 cVDPV2 cases and one cVDPV2 positive environmental sample

::::::

The World is Waiting :: 19TH REPORT – INDEPENDENT MONITORING BOARD – GLOBAL POLIO ERADICATION INITIATIVE
December 2020 :: 78 pages
Conclusions [excerpt]
The Polio Programme is at a pivotal moment in its history. The weaknesses and failures that led it backwards, over a period of two years, from a place that felt close to the global interruption of poliovirus transmission, to the current epidemiological debacle, are still present.

The Global Polio Programme: a failure of adaptation
The Global Polio Eradication Initiative was launched in 1988, with the passion, energy and fundraising tenacity of Rotary International behind it, together with fellow founding partners (WHO, UNICEF, CDC);
it has been hugely successful for most of its lifetime. Other generous donors (major governments, the Bill & Melinda Gates Foundation, Gavi) have become key partners in the endeavour.

This partnership, its organisational structure, its operating procedures, and its impressive infrastructure on the ground, has driven polio almost to extinction.

That this polio eradication endeavour has faltered over recent years should not come as a surprise. It has been tightly controlled and managed by a global entity, the GPEI. It stands or falls by how this global organisation operates. The GPEI is now 32 years old.

Outside the world of health, and well before 32 years are reached, there are many examples of successful businesses and corporations that have run into serious difficulties, and not just because of their longevity. Crucially, it is because their organisational structure, culture, and business model has not adapted to a changing external environment. Perhaps, also, they have looked back at past glories
and not accepted the need to change because they are “too good to fail.”

The GPEI seems to have reached a similar point in its history.

For some time, it has been clear that the world in which the Polio Programme is embedded has changed around it.

The humble drops of oral polio vaccine are given against a constantly fluctuating geopolitical backdrop. Political unanimity on the importance of polio is much more difficult to secure than it was 32 years ago.

The oral polio vaccine has greater value than its disease preventive potency: as a powerful bargaining tool for factional interests wanting something from their governments.

Some communities have become so hostile to the Polio Programme, and so opposed to letting their children have the vaccine, that negative attitudes may have reached the point of no return. Violence, territorial blockades, murders and intimidation, in some geographies, are directed against polio eradication activity, in marked contrast to most other humanitarian programmes.

Countries have received steady streams of external funding and extensive global involvement and facilitation. This has not always encouraged them to take absolute responsibility and regard polio as their country’s problem.

Finding solutions to these fundamental and deep-rooted barriers to eradication is what is now necessary in order to finish the job. This means the Polio Programme doing things very differently from how it made its name.

Its success came from operating as a technical, disease control programme and this took it a long way. It became overmedicalized in the way that it approached the tasks of eradication. It was not skilled in the tasks of modern management, such as: inspiring people; gathering soft intelligence; managing performance; quality improvement; and daily use of data to devise insightful metrics. In particular, social data were greatly undervalued compared to epidemiological data.

Until late in the day, there was no real belief in alternative delivery models, such as integration. There were regular and unsuccessful vertical programme dashes to try to reach the finishing tape.

These are all reasons why the GPEI – from global to regional to national to local level – needs to adapt and do things differently.

At last, the GPEI has started to talk about this. A six-month long strategy formulation process has been facilitated by external consultants with wide stakeholder involvement. It is set to produce “headlines”
in December 2020.

It is essential that this strategy goes beyond problem diagnosis and pointing out what needs to be done. The problems are already well-established and the steps that need to be taken are very clear.

The GPEI, at the request of polio donor countries, carried out and published a governance review. That has not yet been implemented.

There is a great deal of conversation at the moment, within the GPEI leadership and among the donors and wider polio partners, about these matters. It is using up much emotional energy. Some are saying that these reviews and discussions are not on the critical path to eradication.

The revision of the governance of the GPEI, the revision of the strategy of the GPEI, and the revision of the structure of the GPEI are well overdue.

It is important that there is a new, much more effective, and fully accountable GPEI.

Meanwhile, the task of helping the GPEI to move quickly to face, head-on, the task of finding and implementing definitive, transformational and sustainable solutions to its most intractable barriers to
eradication rests with the GPEI leadership and the leaders of the national polio programmes…

::::::
::::::

WHO Grade 3 Emergencies [to 26 Dec 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 26 Dec 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
Iraq – No new digest announcements identified
Libya – No new digest announcements identified
Malawi Floods – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Mozambique – No new digest announcements identified
Myanmar – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

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WHO Grade 1 Emergencies [to 26 Dec 2020]

Chad – No new digest announcements identified
Djibouti – 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
:: Syrian Arab Republic: COVID-19 Humanitarian Update No. 22 As of 23 December 2020
:: Recent Developments in Northwest Syria – Situation Report No. 23 – As of 21 December 2020

Yemen – No new digest announcements identified

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UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
COVID-19
:: Coronavirus Disease (COVID-19): Weekly Epidemiological Update (22 December 2020)

East Africa Locust Infestation – No new digest announcements identified

::::::
::::::

WHO & Regional Offices [to 26 Dec 2020]
22 December 2020 Departmental news
Joint statement calling for urgent country scale-up of access to optimal HIV treatment for infants and children living with HIV

21 December 2020 Departmental news
Mobilizing youth to End TB

21 December 2020 Departmental news
Behavioural considerations for acceptance and uptake of COVID-19 vaccines

::::::

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
:: 24 December 2020 News release
COVID-19 reignites drive for a “One Health” approach to tackle preventable illnesses at the animal-human-ecosystems interface

WHO European Region EURO
:: WHO supports European countries’ response to new virus variant 22-12-2020
:: WHO/Europe’s year in review 2020 22-12-2020
:: Leaving no one behind: access to rehabilitation services is an integral part of universal health coverage 22-12-2020
:: Year-end message by Her Royal Highness The Crown Princess of Denmark, Patron of the WHO Regional Office for Europe 22-12-2020
:: WHO promotes distance care for diabetic patients in Czechia during COVID-19 21-12-2020

WHO Eastern Mediterranean Region EMRO::
:: Heroic health workers losing the battle against COVID-19 23 December 2020
:: Somalia celebrates UHC Day 20 December 2020

WHO Western Pacific Region
No new digest content identified

CDC/ACIP [to 26 Dec 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
CDC to Require Negative COVID-19 Test for Air Travelers from the United Kingdom to the U.S.
Thursday, December 24, 2020

Media Statement from CDC Director Robert R. Redfield on Vaccine Milestone
Wednesday, December 23, 2020
The United States achieved an early but important milestone today – jurisdictions have now reported that more than 1 million people have received their first dose of COVID-19 vaccine since administration began 10 days ago…

Coronavirus Disease 2019 (COVID-19)
Selected Resources
:: Requirement for Proof of Negative COVID-19 Test for All Air Passengers Arriving from the UK to the US Friday, December 25, 2020

:: When Vaccine is Limited, Who Gets Vaccinated First? Wednesday, December 23, 2020

:: EARLY RELEASE: The Advisory Committee on Immunization Practices’ Updated Interim Recommendation for Allocation of COVID-19 Vaccine – United States, December 2020 Tuesday, December 22, 2020

:: Importance of COVID-19 Vaccination for Residents of Long-term Care Facilities Monday, December 21, 2020

Africa CDC [to 26 Dec 2020]
http://www.africacdc.org/
News
Statement on new SARS-CoV-2 variant with multiple spike protein mutations
ADDIS ABABA, ETHIOPIA, 22 DECEMBER 2020. The Africa Centres for Disease Control and Prevention (Africa CDC) wishes to raise awareness of Member States regarding the new variant of SARS-CoV-2, the virus that causes COVID-19, which was reported in South Africa and the United Kingdom over the past week. Africa CDC is closely following up with authorities in South Africa, where the variant was first identified in Nelson Mandela Bay and has rapidly spread through the Eastern and Western Capes, as well as KwaZulu-Natal…

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

National Health Commission of the People’s Republic of China [to 26 Dec 2020]
http://en.nhc.gov.cn/
News
Dec 26: Daily briefing on novel coronavirus cases in China
On Dec 25, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 20 new cases of confirmed infections.

National Medical Products Administration [to 26 Dec 2020]
http://english.nmpa.gov.cn/news.html
News
Official: Vaccines good for at least 6 months
2020-12-24
The COVID-19 vaccine’s protection can last for more than half a year at least, said Zeng Yixin, deputy head of the National Health Commission, at news conference in Beijing on Dec 19.

Official affirms safety of Chinese vaccines
2020-12-22
Experimental COVID-19 vaccines developed by Chinese researchers are safe, and ongoing efforts to push for their market approval will strictly follow the rules of science, a health official said on Dec 21.

China starts building COVID-19 vaccine production facility
2020-12-22
China started the construction of a plant for manufacturing an mRNA-based COVID-19 vaccine on Dec 21, with production operations due to begin in eight months, according to local authorities.

China at forefront of global COVID-19 vaccine development: official
2020-12-22
China is at the forefront of global COVID-19 vaccine development, with most jabs undergoing phase-3 clinical trials, a health official said at a press conference on Dec 21.

Announcements

Paul G. Allen Frontiers Group [to 26 Dec 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

BARDA – U.S. Department of HHS [to 26 Dec 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
December 23, 2020: HHS, DOD collaborate with Merck to continue the development and large-scale manufacturing of investigational COVID-19 treatment
The U.S. Department of the Health and Human Services (HHS) and the Department of Defense (DOD) jointly announced an agreement with Merck to support advanced development and large-scale manufacturing of the their investigational therapeutic MK-7110 to treat hospitalized patients with severe or critical COVID-19.
The investigational therapeutic is a promising first-in-class fusion protein and immune modulator. Immune modulators have the potential to minimize the damaging effects of an overactive immune response to COVID-19. This overactive response can contribute to the severity of the illness…

December 23, 2020: Trump Administration purchases additional 100 million doses of COVID-19 investigational vaccine from Pfizer
… Under the agreement, Pfizer will manufacture and deliver up to 100 million doses of its SARS-CoV-2 vaccine, BNT162b2, to Government designated locations. Under the terms of the agreement, Pfizer will deliver at least 70 million doses by June 30, 2021, with the balance of the 100 million doses to be delivered no later than July 31, 2021…

BMGF – Gates Foundation [to 26 Dec 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 26 Dec 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 26 Dec 2020]
https://carb-x.org/
News
No new digest content identified.

CEPI – Coalition for Epidemic Preparedness Innovations [to 26 Dec 2020]
http://cepi.net/
Latest News
Coming soon: Call to join CEPI’s Scientific Advisory Committee
24 Dec 2020
To ensure world class rigour in our work advancing the development of vaccines against COVID-19 and other emerging health threats, CEPI is looking for senior scientific researchers and global health professionals to join its Scientific Advisory Committee, or SAC. We will be seeking applicants with extensive experience in disciplines relating to vaccine development, innovation, licensure, and deployment. The formal period for application will open in January.
Working as an independent body, the SAC advises CEPI staff and the Board on funding and R&D decisions relating to our vaccine programmes and enabling sciences activities, as well as the overall vaccine portfolio and scientific aspects of the CEPI strategy.
Up to twenty-five positions will be available – including the role of CEPI SAC Chair and Vice-Chair. Existing members are invited to re-apply to serve an additional 2-year period…

EDCTP [to 26 Dec 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
No new digest content identified.

Emory Vaccine Center [to 26 Dec 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Medicines Agency [to 26 Dec 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: EMA organises a second public meeting about the new COVID-19 vaccines
Last updated: 22/12/2020
EMA will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines.
Together with the EU medicines regulatory network, EMA has been working around the clock to bring much needed COVID-19 vaccines to EU citizens as quickly as possible, while keeping the same rigorous standards of approval as for all vaccines.
The first COVID-19 vaccine, Comirnaty, developed by BioNTech and Pfizer has been authorised in the EU on 21 December 2020. An application for a marketing authorisation for another COVID-19 vaccine, developed by Moderna, is currently ongoing and could be concluded at an extraordinary meeting of EMA’s human medicines committee (CHMP) on 6 January 2021…

News: EMA recommends first COVID-19 vaccine for authorisation in the EU (updated)
CHMP, Last updated: 22/12/2020
[See Regulatory Milestones above for detail]

European Vaccine Initiative [to 26 Dec 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

FDA [to 26 Dec 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
December 22, 2020 – Coronavirus (COVID-19) Update: December 22, 2020
:: The FDA has posted translations of the Moderna COVID-19 Vaccine fact sheet for recipients and caregivers, and the fact sheet for healthcare providers in languages including: Arabic, Chinese, French, Spanish, Tagalog, and Vietnamese. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations.

December 21, 2020 – Coronavirus (COVID-19) Update: December 21, 2020
:: The FDA has posted translations of the Pfizer-BioNTech COVID-19 Vaccine fact sheet for recipients and caregivers in languages including: Arabic, Burmese, Cherokee, Chinese (Simplified and Traditional), Chuukese, German, Haitian Creole, Hindi, Hmong, Korean, Mam, Polish, Portuguese, Russian, Spanish, Somali, Tagalog, Vietnamese, and Yiddish. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations.
:: Today, the agency updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures, and highlights on the FDA’s response efforts.

FDA – COVID-19 Vaccines [to 26 Dec 2020]
www.fda.gov/covid19vaccines
News and Updates; Upcoming Events
No new digest content identified.

Fondation Merieux [to 26 Dec 2020]
http://www.fondation-merieux.org/
News, Events
Press Releases
No new digest content identified.

Gavi [to 26 Dec 2020]
https://www.gavi.org/
News releases
No new digest content identified.

GHIT Fund [to 26 Dec 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
Press Releases
No new digest content identified.

Global Fund [to 26 Dec 2020]
https://www.theglobalfund.org/en/news/
News
Global Fund has awarded $1 billion to support countries’ COVID-19 responses, but funding for this purpose is now fully deployed
22 December 2020
The Global Fund has awarded nearly US$1 billion to 106 countries to support their responses to COVID-19, but has now fully deployed all its funding for this purpose. There are significant further needs for immediate funding, including for personal protective equipment (PPE), testing and treatment, and to mitigate the impact on lifesaving HIV, TB and malaria programs…

News
Denmark, Norway and Sweden Support Global Fund’s COVID-19 Response By Contributing a Total US$45 million
21 December 2020
The Global Fund praises Denmark, Norway and Sweden for allocating a total US$45 million to the Global Fund’s efforts to support low- and middle-income countries to fight COVID-19. Denmark, Norway and Sweden respectively pledged DKK 25 million, NOK 285.2 million and SEK 100 million…

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 26 Dec 2020]
https://www.glopid-r.org/news/
News
GloPID-R COVID-19 highlights of 2020
22/12/2020
As we approach the end of 2020, GloPID-R would like to thank its members, observers and partners for their collaboration,…

Hilleman Laboratories [to 26 Dec 2020]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 26 Dec 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Release
Reflections on 2020
Dec 21, 2020

IAVI [to 26 Dec 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
No new digest content identified.

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

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

IFRC [to 26 Dec 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.

Institut Pasteur [to 26 Dec 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…

IRC International Rescue Committee [to 26 Dec 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
Iraq: Amid a recent rise in reported domestic violence cases, IRC warns of a shadow pandemic spreading across the country​
December 22, 2020

IVAC [to 26 Dec 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

IVI [to 26 Dec 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

JEE Alliance [to 26 Dec 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

Johns Hopkins Center for Health Security [to 26 Dec 2020]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
Johns Hopkins Center for Health Security and National Organizations Call for Action to Implement Crisis Standards of Care During COVID-19 Surge
December 18, 2020
… The Johns Hopkins Center for Health Security and 8 other national organizations have issued a statement calling for immediate action to implement crisis standards of care (CSC) during the current COVID-19 surge. CSC occur when health care resource shortages – such as staff, hospital beds, and medications – are severe enough to require a change in conventional standards and processes care. Many hospitals and localities are experiencing such shortages now. When limited resources require tough decisions, CSC plans ensure that the most good is done for the largest number of people.
Our joint statement recommends key actions for governors, state health departments, and hospitals and health systems to support, plan for, and equitably implement crisis standards of care. A list of CSC tools and resources is also available. Please take a moment to read our statement today. Urgent action is essential to prevent further loss of life…

MSF/Médecins Sans Frontières [to 26 Dec 2020]
http://www.msf.org/
Latest [Selected Announcements]
Central African Republic
Medical care at arm’s length: the continuous struggle of the people of…
Project Update 24 Dec 2020

Sudan
“Services for the refugees need to increase, otherwise it will be a dis…
Project Update 23 Dec 2020

Mali
Central Mali: no choice but to flee
Project Update 22 Dec 2020

National Vaccine Program Office – U.S. HHS [to 26 Dec 2020]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

NIH [to 26 Dec 2020]
http://www.nih.gov/news-events/news-releases
News Releases
Results of NIH-sponsored ACTIV-3 trial published
December 22, 2020 — Experimental monoclonal antibody not efficacious in Phase 3 trial.
Preliminary results of a Phase 3, randomized, placebo-controlled clinical trial testing the investigative monoclonal antibody LY-CoV555 in hospitalized COVID-19 patients were published today in The New England Journal of Medicine. The antibody did not provide clinical benefit compared to placebo. The trial, which had been halted to new enrollment in late October following a recommendation by the independent Data and Safety Monitoring Board (DSMB), is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health…

Pregnant women in third trimester unlikely to pass SARS-CoV-2 infection to newborns
December 22, 2020 — NIH-funded findings also suggest less-than-expected transfer of maternal SARS-CoV-2 antibodies through placenta.

NIH holds COVID-19 vaccine kick-off event
December 21, 2020 — NIH Clinical Center front-line workers, Azar, Collins, Fauci to receive doses from agency’s initial stock.

NIH funds eight studies to uncover risk factors for COVID-19-related inflammatory syndrome in children
December 21, 2020 — Awards part of a larger effort to study pediatric COVID-19 and related conditions.

NIH to support radical approaches to nationwide COVID-19 testing and surveillance
December 21, 2020 — RADx-rad program will fund non-traditional and repurposed technologies to combat the current pandemic and address future viral disease outbreaks.
The National Institutes of Health has awarded over $107 million to support new, non-traditional approaches and reimagined uses of existing tools to address gaps in COVID-19 testing and surveillance. The program also will develop platforms that can be deployed in future outbreaks of COVID-19 and other infectious diseases. A part of the Rapid Acceleration of Diagnostics (RADx) initiative, the awards from the RADx Radical (RADx-rad) program will support 49 research projects and grant supplements at 43 institutions across the United States. It will focus on non-traditional viral screening approaches, such as biological or physiological markers, new analytical platforms with novel chemistries or engineering, rapid detection strategies, point-of-care devices, and home-based testing technologies.
“To solve a problem as complicated as COVID-19, we need ideas, tools, and technologies that challenge the way we think about pandemic control,” said NIH Director Francis S. Collins, M.D., Ph.D. “These awards from the RADx-rad program provide superb examples of outside-the-box concepts that will help us overcome this pandemic and give us a cadre of devices and tactics to confront future outbreaks.”…

PATH [to 26 Dec 2020]
https://www.path.org/media-center/
Press Release
No new digest content identified.

Rand [to 26 Dec 2020]
https://www.rand.org/pubs.html
Selected Research Reports/Journal Articles
Research Brief
The economic benefits of equitable global access to COVID-19 vaccines
Researchers used a global macroeconomic model to examine the economic effects of vaccine nationalism. This brief highlights the cost to 30 high-income countries if low and middle-income countries miss out on initial access to COVID-19 vaccines.
Dec 17, 2020
Marco Hafner, Erez Yerushalmi, Clement Fays, Eliane Dufresne, Christian Van Stolk

Sabin Vaccine Institute [to 26 Dec 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

UNAIDS [to 26 Dec 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
Joint statement calling for urgent country scale-up of access to optimal HIV treatment for infants and children living with HIV
22 December 2020
Global partners that are committed to ending paediatric AIDS have come together to call on countries to rapidly scale up access to optimal, child-friendly HIV treatment for infants and children. The partners include the United Nations Children’s Fund, the World Health Organization (WHO), UNAIDS, the United States President’s Emergency Plan for AIDS Relief, the Global Fund to Fight AIDS, Tuberculosis and Malaria, Unitaid, the Elizabeth Glaser Pediatric AIDS Foundation, and the Clinton Health Access Initiative (CHAI).
Children living with HIV continue to be left behind by the global AIDS response. In 2019, only 53% (950 000) of the 1.8 million children living with HIV (aged 0–14 years) globally were diagnosed and on treatment, compared to 68% of adults. [1] The remaining 850 000 children living with HIV have not been diagnosed and are not receiving life-saving HIV treatment. Two thirds of the missing children are aged 5–14 years and do not routinely attend traditional health facilities. Engaging communities and the families of people living with HIV, tuberculosis and other related diseases and offering family services are needed in order to find and start on treatment those missing children.
An estimated 95 000 children died of AIDS-related illnesses in 2019, in part due to lack of early diagnosis of HIV among infants and children and immediate linkage to optimal HIV treatment regimens. Untreated, 50% of infants infected with HIV during or around the time of birth will die before the age of two years. [1]…

UNICEF [to 26 Dec 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Press release
12/22/2020
Mozambique: Malnutrition and deadly diseases threaten 250,000 displaced children in Cabo Delgado province as the rainy season starts

News note
UNICEF and the World Economic Forum sign charter with 18 shipping, airlines and logistics companies to deliver COVID-19 vaccines
NEW YORK/ WASHINGTON DC,  21 December 2020 —The unprecedented magnitude of the pandemic requires innovative and bold collective action from multinational organizations, governments and industries for inclusive and efficient distribution of safe vaccines. With lives and livelihoods of millions across the globe depending on multiple stakeholders harnessing the power of collective action – whether in the field of health delivery, goods delivery or humanitarian service delivery, the logistics sector and UNICEF will play a central role in vaccine distribution.
Recognizing this need, 18 shipping, airlines and logistics industry CEOs, the Executive Director of UNICEF, and the President of the World Economic Forum, have signed a charter supporting UNICEF and COVAX countries in four main ways:
[1] Engage with governments, customs authorities, UNICEF and other UN Agencies, and NGOs;
[2] Participate in operational asset and competency sharing
[3] Assign expertise to support governments, where requested by UNICEF
[4] Support UNICEF’s Global Vaccine Logistics Distribution, for COVID-19, with prioritization and solutions for international and in country distribution of vaccines and related supplies on behalf of the COVAX facility

News note
12/21/2020
UNICEF launches the COVID-19 vaccine market dashboard
As the designated COVAX procurement coordinator and procurement agent, UNICEF has launched the COVID-19 Vaccine Market Dashboard – an interactive tool for countries, partners and industry to follow the developments of the rapidly evolving COVID-19 vaccine market and the efforts of the COVAX Facility to ensure fair and equitable access for every country in the world.
In this first release, the dashboard provides a regularly updated overview of the global research and development pipeline, the projected production capacity, publicly announced bilateral and multilateral supply agreements, as well as reported price points…

Unitaid [to 26 Dec 2020]
https://unitaid.org/
Featured News
22 December 2020
Unitaid welcomes US$40 million from Norway to fight COVID-19
Geneva – Unitaid is pleased to welcome a contribution of NOK 350 million (US$40 million) from Norway towards its vital work on COVID-19 treatments and tests.
As a founding member of Unitaid, Norway has been a longstanding supporter of its efforts to bring forward life-saving global health innovations.
This funding will enable Unitaid to advance the development and equitable access to therapeutics and diagnostics for COVID-19 in low- and middle-income countries, under the umbrella of the global Access to COVID Tools Accelerator (ACT-A).
The focus will be twofold: firstly, collaborating with FIND and industry partners to push forward the development of high-quality, affordable self-tests for COVID-19 that are suitable for use in low-resource settings.
Secondly, Unitaid will work with ACT-A partners to adapt COVID-19 treatments and initiate country preparedness for promising treatments such as monoclonal antibodies…

Vaccination Acceptance Research Network (VARN) [to 26 Dec 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

Vaccine Confidence Project [to 26 Dec 2020]
http://www.vaccineconfidence.org/
News, Research and Reports
No new digest content identified.

Vaccine Education Center – Children’s Hospital of Philadelphia [to 26 Dec 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
News
COVID RESOURCES
:: A Look at Each Vaccine: COVID-19 Vaccine
https://www.chop.edu/centers-programs/vaccine-education-center/vaccine-details/covid-19-vaccine

:: COVID-19 MRNA VACCINES: WHAT YOU SHOULD KNOW
https://media.chop.edu/data/files/pdfs/vaccine-education-center-covid-qa.pdf

:: Questions and Answers about COVID-19 Vaccines
https://www.chop.edu/centers-programs/vaccine-education-center/making-vaccines/prevent-covid

Wellcome Trust [to 26 Dec 2020]
https://wellcome.ac.uk/news
News
No new digest content identified.

The Wistar Institute [to 26 Dec 2020]
https://www.wistar.org/news/press-releases
Press Releases
Dec. 23, 2020
Wistar Reports New Class of Antibiotics Active Against a Wide Range of Bacteria
Dual-acting immuno-antibiotics block an essential pathway in bacteria and activate the adaptive immune response.

WFPHA: World Federation of Public Health Associations [to 26 Dec 2020]
https://www.wfpha.org/
Latest News
Rejecting All Collaborations of Public Health Organizations with the Tobacco Industry
Dec 22, 2020
The tobacco epidemic is an urgent public health concern, with tobacco use responsible for more than 8 million deaths annually. In 2003, the World Health Assembly…

World Organisation for Animal Health (OIE) [to 26 Dec 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
No new digest content identified.

::::::

ARM [Alliance for Regenerative Medicine] [to 26 Dec 2020]
https://alliancerm.org/
Press Releases
No new digest content identified.

BIO [to 26 Dec 2020]
https://www.bio.org/press-releases
Press Releases
Modernizing Oversight of Animal Biotechnology Will Help Tackle Climate Change and Nutrition Challenges
December 21, 2020
The Biotechnology Innovation Organization (BIO) appreciates the U.S. Department of Agriculture’s (USDA) longstanding commitment to food and agricultural innovation and looks forward to reviewing the Advanced Notice of Proposed Rulemaking (ANPR) aimed at restructuring the U.S. regulatory system for animal biotechnology…

DCVMN – Developing Country Vaccine Manufacturers Network [to 26 Dec 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

ICBA – International Council of Biotechnology Associations [to 26 Dec 2020]
https://internationalbiotech.org/news/
News
No new digest content identified.

IFPMA [to 26 Dec 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

PhRMA [to 26 Dec 2020]
http://www.phrma.org/
Selected Press Releases, Statements
American biopharmaceutical manufacturing: Fueling economic growth now and for years to come
December 21, 2020
As the world has grappled with the current pandemic, there has been increased focus on biopharmaceutical manufacturing and its global supply chain. Many wondered whether the biopharmaceutical industry could ensure continued and uninterrupted supply of innovative medicines relied on by so many Americans, as well as develop and supply new treatments and vaccines to address the pandemic. We are nearly a year into this public health crisis, and the biopharmaceutical manufacturing industry has stepped up to help beat COVID-19 in more ways than one. A new report from TEConomy Partners takes a closer look at what makes the U.S. biopharmaceutical manufacturing industry so globally competitive…

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

AMA Journal of Ethics
Volume 22, Number 12: E981-1070
https://journalofethics.ama-assn.org/issue/socially-situated-brain-death

Socially Situated Brain Death
In 1980, the Uniform Determination of Death Act (UDDA) defined death as “(1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem … in accordance with accepted medical standards.” Interpreting the UDDA definition and applying neurological criteria for diagnosing brain death sound straightforward. Brain death is, however, socially situated, not observer independent, and fraught with uncertainty and ambiguity. This issue investigates some of the ethical, cultural, and legal complexities of one of medicine’s most critical tasks: being sharp and sure about who is alive and who is dead.
Full Issue PDF

Annals of Internal Medicine
15 December 2020 Volume 173, Issue 12
http://annals.org/aim/issue

Original Research
Attitudes Toward a Potential SARS-CoV-2 Vaccine – A Survey of U.S. Adults
FREE
Kimberly A. Fisher, MD, MSc, Sarah J. Bloomstone, BA, Jeremy Walder, DO, … et al.
Pages:964–973
Once a COVID-19 vaccine becomes available, maximizing uptake and coverage will be important. This national survey explored factors associated with vaccine hesitancy. The results suggest that multipronged efforts will be needed to increase acceptance of the vaccine

Annals of Internal Medicine
15 December 2020 Volume 173, Issue 12
http://annals.org/aim/issue

Editorials
SARS-CoV-2 Vaccine Acceptance: We May Need to Choose Our Battles
Alison M. Buttenheim, PhD, MBA
Pages:1018–1019
Fisher and colleagues reported a U.S. survey in which about 6 in 10 respondents intend to receive a COVID-19 vaccine when it becomes available. The editorialist discusses why closing the intention-to-behavior gap is likely to have population health benefit.

The CRISPR Journal
Volume 3, Issue 6 / December 2020
https://www.liebertpub.com/toc/crispr/3/6

Perspective Free
Heritable Human Genome Editing: The Public Engagement Imperative
Eli Y. Adashi, et al
Pages:434–439
Published Online:17 December 2020
https://doi.org/10.1089/crispr.2020.0049
Abstract
In the view of many, heritable human genome editing (HHGE) harbors the remedial potential of ridding the world of deadly genetic diseases. A Hippocratic obligation, if there ever was one, HHGE is widely viewed as a life-sustaining proposition. The national go/no-go decision regarding the implementation of HHGE, however, must not, in the collective view of the authors, proceed absent thorough public engagement. A comparable call for an “extensive societal dialogue” was recently issued by the International Commission on the Clinical Use of Human Germline Genome Editing. In this communication, the authors lay out the foundational principles undergirding the formation, modification, and evaluation of public opinion. It is against this backdrop that the societal decision to warrant or enjoin the clinical conduct of HHGE will doubtlessly transpire.

Disaster Medicine and Public Health Preparedness
Volume 14 – Issue 5 – October 2020
https://www.cambridge.org/core/journals/disaster-medicine-and-public-health-preparedness/latest-issue

Systematic Review
Data Collection Tools for Maternal and Child Health in Humanitarian Emergencies: An Updated Systematic Review
Juliana Lima Constantino, Fernanda Dias Romeiro, Theresa Diaz, Allisyn C Moran, Cynthia Boschi-Pinto
Published online by Cambridge University Press: 10 December 2019, pp. 601-619
Abstract
The worst rates of preventable mortality and morbidity among women and children occur in humanitarian settings. Reliable, easy-to-use, standardized, and efficient tools for data collection are needed to enable different organizations to plan and act in the most effective way. In 2015, the World Health Organization (WHO) commissioned a review of tools for data collection on the health of women and children in humanitarian emergencies. An update of this review was conducted to investigate whether the recommendations made were taken forward and to identify newly developed tools. Fifty-three studies and 5 new tools were identified. Only 1 study used 1 of the tools identified in our search. Little has been done in terms of the previous recommendations. Authors may not be aware of the availability of such tools and of the importance of documenting their data using the same methods as other researchers. Currently used tools may not be suitable for use in humanitarian settings or may not include the domains of the authors’ interests. The development of standardized instruments should be done with all key workers in the area and could be coordinated by the WHO.

Disaster Medicine and Public Health Preparedness
Volume 14 – Issue 5 – October 2020
https://www.cambridge.org/core/journals/disaster-medicine-and-public-health-preparedness/latest-issue

Report from the Field
Developing a Public Health Monitoring System in a War-torn Region: A Field Report From Iraqi Kurdistan
Stefania Moramarco, Faiq B. Basa, Haveen H. Alsilefanee, Sivar A. Qadir, Leonardo Emberti Gialloreti
Published online by Cambridge University Press: 05 November 2019, pp. 620-622

Epidemics
Volume 33 December 2020
https://www.sciencedirect.com/journal/epidemics/vol/33/suppl/C

Review article Open access
Deriving risk maps from epidemiological models of vector borne diseases: State-of-the-art and suggestions for best practice
Yanchao Cheng, Nils Benjamin Tjaden, Anja Jaeschke, Stephanie Margarete Thomas, Carl Beierkuhnlein
Article 100411

Epidemics
Volume 33 December 2020
https://www.sciencedirect.com/journal/epidemics/vol/33/suppl/C

Review article Open access
Responsible modelling: Unit testing for infectious disease epidemiology
Tim C.D. Lucas, Timothy M Pollington, Emma L Davis, T Déirdre Hollingsworth
Article 100425

Global Health: Science and Practice (GHSP)
Vol. 8, No. 4 December 23, 2020
http://www.ghspjournal.org/content/current

ORIGINAL ARTICLES
Health Care Worker Preferences and Perspectives on Doses per Container for 2 Lyophilized Vaccines in Senegal, Vietnam, and Zambia
Natasha Kanagat, Kirstin Krudwig, Karen A. Wilkins, Sydney Kaweme, Guissimon Phiri, Frances D. Mwansa, Mercy Mvundura, Joanie Robertson, Debra Kristensen, Abdoulaye Gueye, Sang D. Dao, Pham Q. Thai, Huyen T. Nguyen and Thang C. Tran
Global Health: Science and Practice December 2020, 8(4):680-688; https://doi.org/10.9745/GHSP-D-20-00112
When providing immunization services, health care workers balance the mandate of achieving high coverage with limiting vaccine wastage. Workers in 3 countries said that containers with fewer vaccine doses for measles and BCG would enable them to immunize all children who present, while reducing concerns about wasting vaccine.

Health Policy and Planning
Volume 35, Issue Supplement_2, November 2020
https://academic.oup.com/heapol/issue/35/Supplement_2

SUPPLEMENT
Innovations in Implementation Research in Low- and Middle-Income Countries
Editorial
Implementation research in LMICs—evolution through innovation
Kabir Sheikh, James Hargreaves, Mishal Khan, Sandra Mounier-Jack
Extract
Major global health gains can be achieved by strengthening the delivery of public health policies and programmes in low- and middle-income countries (LMICs). The population impact of evidence-based technologies and interventions such as drugs, vaccines and health know-how can only be maximized where programmes optimally identify and reach target populations and support them to take up and sustain their effective use. Examples include significant gaps in the coverage and quality of maternal health, newborn, immunization, non-communicable disease, primary care and adolescent sexual and reproductive health services—all issues tackled in this supplement. While structural change…

Health Policy and Planning
Volume 35, Issue Supplement_2, November 2020
https://academic.oup.com/heapol/issue/35/Supplement_2

Supplement Articles
How to evaluate the implementation of complex health programmes in low-income settings: the approach of the Gavi Full Country Evaluations
Caroline Soi, Jessica C Shearer, Ashwin Budden, Emily Carnahan, Nicole Salisbury …
Health Policy and Planning, Volume 35, Issue Supplement_2, November 2020, Pages ii35–ii46, https://doi.org/10.1093/heapol/czaa127
Abstract
Vaccination, like most other public health services, relies on a complex package of intervention components, functioning systems and committed actors to achieve universal coverage. Despite significant investment in immunization programmes, national coverage trends have slowed and equity gaps have grown. This paper describes the design and implementation of the Gavi Full Country Evaluations, a multi-country, prospective, mixed-methods approach whose goal was to monitor and evaluate processes, inputs, outputs and outcomes of immunization programmes in Bangladesh, Mozambique, Uganda and Zambia. We implemented the Full Country Evaluations from 2013 to 2018 with the goal of identifying the drivers of immunization programme improvement to support programme implementation and increase equitable immunization coverage. The framework supported methodological and paradigmatic flexibility to respond to a broad range of evaluation and implementation research questions at global, national and cross-country levels, but was primarily underpinned by a focus on evaluating processes and identifying the root causes of implementation breakdowns. Process evaluation was driven by theories of change for each Gavi funding stream (e.g. Health Systems Strengthening) or activity, ranging from global policy development to district-level programme implementation. Mixing of methods increased in relevance and rigour over time as we learned to build multiple methods into increasingly tailored evaluation questions. Evaluation teams in country-based research institutes increasingly strengthened their level of embeddedness with immunization programmes as the emphasis shifted over time to focus more heavily on the use of findings for programme learning and adaptation. Based on our experiences implementing this approach, we recommend it for the evaluation of other complex interventions, health programmes or development assistance.

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.

JAMA
December 22/29, 2020, Vol 324, No. 24, Pages 2467-2566
https://jamanetwork.com/journals/jama/currentissue

Viewpoint
Accelerating Global Improvements in Health Care Quality
Sheila Leatherman, MSW; Donald M. Berwick, MD, MPP
free access has multimedia
JAMA. 2020;324(24):2479-2480. doi:10.1001/jama.2020.17628
This Viewpoint proposes a policy framework for thinking about health care quality in low- and middle-income countries, emphasizing the importance of infrastructure, enforceable quality standards, safety practices, guideline-directed clinical care, and patient and family involvement.

JAMA
December 22/29, 2020, Vol 324, No. 24, Pages 2467-2566
https://jamanetwork.com/journals/jama/currentissue

Health Agencies Update
December 22/29, 2020
More Transparency Needed for COVID-19 Emergency Authorizations
Rita Rubin, MA
JAMA. 2020;324(24):2475. doi:10.1001/jama.2020.24201
To improve public trust, the US Food and Drug Administration (FDA) should be more transparent in publicly disclosing its reviews of safety and effectiveness data leading to Emergency Use Authorization (EUA) of coronavirus disease 2019 (COVID-19) vaccines and treatments, according to a recent report from the US Government Accountability Office (GAO)…

JAMA Network
COVID-19 Update December 26, 2020

These articles on COVID-19 were published across the JAMA Network in the last week.
Selected Articles
[No digest content identified]

Journal of Travel Medicine
Volume 27, Issue 8, December 2020

Perspectives
The International Health Regulations (2005) and the re-establishment of international travel amidst the COVID-19 pandemic
Barbara J von Tigerstrom, PhD, Sam F Halabi, JD, Kumanan R Wilson, MD
Journal of Travel Medicine, Volume 27, Issue 8, December 2020, taaa127, https://doi.org/10.1093/jtm/taaa127
As countries modify or lift travel restrictions implemented in response to the COVID-19 pandemic, some variation in approaches is to be expected, but harmonization is important to re-establishing international travel. Despite challenges, the International Health Regulations (2005) and WHO recommendations can provide a balance of consistency and flexibility.

Journal of Travel Medicine
Volume 27, Issue 8, December 2020

Call to avert acceleration of COVID-19 from India’s Sabarimala pilgrimage of 25 million devotees
K Rajasekharan Nayar, Shaffi Fazaludeen Koya, Venkitesh Ramakrishnan, Arathi P Rao, Gnanaseelan Kanakamma Libu …
Journal of Travel Medicine, Volume 27, Issue 8, December 2020, taaa153, https://doi.org/10.1093/jtm/taaa153
India has the third-highest COVID-19 burden. Hosting the Sabarimala pilgrimage of an estimated 25 million can compromise the near-mitigated but fragile COVID-19 status of the host State of Kerala, accelerate the ongoing outbreaks in other states of India, and potentially in multiple countries with emigrants from Kerala.

Journal of Travel Medicine
Volume 27, Issue 8, December 2020

Public health emergencies of international concern: a historic overview
Annelies Wilder-Smith, MD, Sarah Osman, MPH
Journal of Travel Medicine, Volume 27, Issue 8, December 2020, taaa227, https://doi.org/10.1093/jtm/taaa227
Abstract
Rationale
The International Health Regulations (IHR) have been the governing framework for global health security since 2007. Declaring public health emergencies of international concern (PHEIC) is a cornerstone of the IHR. Here we review how PHEIC are formally declared, the diseases for which such declarations have been made from 2007 to 2020 and justifications for such declarations.
Key findings
Six events were declared PHEIC between 2007 and 2020: the 2009 H1N1 influenza pandemic, Ebola (West African outbreak 2013–2015, outbreak in Democratic Republic of Congo 2018–2020), poliomyelitis (2014 to present), Zika (2016) and COVID-19 (2020 to present). Poliomyelitis is the longest PHEIC. Zika was the first PHEIC for an arboviral disease. For several other emerging diseases a PHEIC was not declared despite the fact that the public health impact of the event was considered serious and associated with potential for international spread.
Recommendations
The binary nature of a PHEIC declaration is often not helpful for events where a tiered or graded approach is needed. The strength of PHEIC declarations is the ability to rapidly mobilize international coordination, streamline funding and accelerate the advancement of the development of vaccines, therapeutics and diagnostics under emergency use authorization. The ultimate purpose of such declaration is to catalyse timely evidence-based action, to limit the public health and societal impacts of emerging and re-emerging disease risks while preventing unwarranted travel and trade restrictions.

Journal of Travel Medicine
Volume 27, Issue 8, December 2020

Use of face masks and other personal preventive measures by Hajj pilgrims and their impact on health problems during the Hajj
Abrar K Alasmari, PhD, Phil J Edwards, PhD, Abdullah M Assiri, MD, Ronald H Behrens, MD, Amaya L Bustinduy, PhD
Journal of Travel Medicine, Volume 27, Issue 8, December 2020, taaa155, https://doi.org/10.1093/jtm/taaa155

Journal of Travel Medicine
Volume 27, Issue 8, December 2020

Estimating the COVID-19 risk during the Hajj pilgrimage
Anas Khan, MD, Kingsley Lezor Bieh, MSc, Ahmed El-Ganainy, MD, Sujoud Ghallab, MBBS, Abdullah Assiri, MD …
Journal of Travel Medicine, Volume 27, Issue 8, December 2020, taaa157, https://doi.org/10.1093/jtm/taaa157

Nature
Volume 588 Issue 7839, 24 December 2020
http://www.nature.com/nature/current_issue.html

2020: the year in review
Editorial | 22 December 2020
A review of 2020 through Nature’s editorials
From the COVID pandemic to a momentous US election, Nature’s editorials provide a lens through which to view an extraordinary year.

Nature
Volume 588 Issue 7839, 24 December 2020
http://www.nature.com/nature/current_issue.html

News Feature | 15 December 2020
Nature’s 10: ten people who helped shape science in 2020
A COVID vaccine developer, an Arctic voyager and a prime minister are some of the people behind the year’s big research stories.
David Cyranoski, Elie Dolgin[…] & Nidhi Subbaraman

Nature
Volume 588 Issue 7839, 24 December 2020
http://www.nature.com/nature/current_issue.html

Editorial | 15 December 2020
Nature’s 10: the human stories behind an extraordinary year in science
Ten profiles illustrate an unforgettable year that propelled research teams to the front of the world’s stage.

Nature
Volume 588 Issue 7839, 24 December 2020
http://www.nature.com/nature/current_issue.html

News | 14 December 2020
Arab nations first to approve Chinese COVID vaccine — despite lack of public data
The United Arab Emirates and Bahrain say the vaccine is 86% effective, but scientists would like to see data to support the claim.
David Cyranoski
Two Arab nations have become the first countries to approve a Chinese COVID-19 vaccine, a significant boost for China’s plans to roll out its vaccines worldwide. The United Arab Emirates (UAE) approved a vaccine developed by Chinese state-owned Sinopharm on 9 December, and Bahrain followed days later. But researchers say a lack of public data on the safety and efficacy of the vaccine could hinder the company’s plans to distribute the vaccine in a range of other countries…

Nature
Volume 588 Issue 7839, 24 December 2020
http://www.nature.com/nature/current_issue.html

Comment | 17 December 2020
The WHO’s chief scientist on a year of loss and learning
The head of scientific work at the World Health Organization reflects on the agency’s challenges and achievements as it navigates the COVID pandemic.
Soumya Swaminathan

Nature
Volume 588 Issue 7839, 24 December 2020
http://www.nature.com/nature/current_issue.html

Correspondence | 18 December 2020
Science advisers around the world on 2020
Seven government researchers who helped to guide their governments’ responses to the COVID-19 pandemic speak out.
Gordon Awandare, Emmanuel André[…] & Mona Nemer

PharmacoEconomics
Volume 38, issue 12, December 2020
https://link.springer.com/journal/40273/volumes-and-issues/38-12

Articles
Recalibrating Health Technology Assessment Methods for Cell and Gene Therapies
Authors
Aris Angelis, Huseyin Naci, Allan Hackshaw, Content type: Practical Application
Published: 22 September 2020
Pages: 1297 – 1308
Abstract
Recently licensed cell and gene therapies have promising but highly uncertain clinical benefits. They are entering the market at very high prices, with the latest entrants costing hundreds of thousands of dollars. The significant long-term uncertainty posed by these therapies has already complicated the use of conventional economic evaluation approaches such as cost-effectiveness and cost-utility analyses, which are widely used for assessing the value of new health interventions. Cell and gene therapies also risk jeopardising healthcare systems’ financial sustainability. As a result, there is a need to recalibrate the current health technology assessment methods used to measure and compensate their value. In this paper, we outline a set of technical adaptations and methodological refinements to address key challenges in the appraisal of cell and gene therapies’ value, including the assessment of efficiency and affordability. We also discuss the potential role of alternative financing mechanisms. Ultimately, uncertainties associated with cell and gene therapies can only be meaningfully addressed by improving the evidence base supporting their approval and adoption in healthcare systems.

PLoS One
http://www.plosone.org/
[Accessed 26 Dec 2020]

A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates
Donald A. Berry, Scott Berry, Peter Hale, Leah Isakov, Andrew W. Lo, Kien Wei Siah, Chi Heem Wong
Research Article | published 23 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0244418
Abstract
We compare and contrast the expected duration and number of infections and deaths averted among several designs for clinical trials of COVID-19 vaccine candidates, including traditional and adaptive randomized clinical trials and human challenge trials. Using epidemiological models calibrated to the current pandemic, we simulate the time course of each clinical trial design for 756 unique combinations of parameters, allowing us to determine which trial design is most effective for a given scenario. A human challenge trial provides maximal net benefits—averting an additional 1.1M infections and 8,000 deaths in the U.S. compared to the next best clinical trial design—if its set-up time is short or the pandemic spreads slowly. In most of the other cases, an adaptive trial provides greater net benefits.

PLoS One
http://www.plosone.org/
[Accessed 26 Dec 2020]

Americans’ perceptions of privacy and surveillance in the COVID-19 pandemic
Baobao Zhang, Sarah Kreps, Nina McMurry, R. Miles McCain
Research Article | published 23 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0242652

PLoS One
http://www.plosone.org/
[Accessed 26 Dec 2020]

Public policy and economic dynamics of COVID-19 spread: A mathematical modeling study
Uri Goldsztejn, David Schwartzman, Arye Nehorai
Research Article | published 22 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0244174

PLoS One
http://www.plosone.org/
[Accessed 26 Dec 2020]

Decreased diarrheal and respiratory disease in HIV exposed uninfected children following vaccination with rotavirus and pneumococcal conjugate vaccines
Gbolahan Ajibola, Kara Bennett, Kathleen M. Powis, Michael D. Hughes, Jean Leidner, Samuel Kgole, Oganne Batlang, Mompati Mmalane, Joseph Makhema, Shahin Lockman, Roger Shapiro
Research Article | published 21 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0244100

Public Health
Volume 189 Pages 1-162 (December 2020)
https://www.sciencedirect.com/journal/public-health/vol/189/suppl/C

Review article Full text access
Psychological impact of infectious disease outbreaks on pregnant women: rapid evidence review
S.K. Brooks, D. Weston, N. Greenberg
Pages 26-36

Public Health
Volume 189 Pages 1-162 (December 2020)
https://www.sciencedirect.com/journal/public-health/vol/189/suppl/C

Letter to the Editor
Correspondence Full text access
Delays in polio vaccination programs due to COVID-19 in Pakistan: a major threat to Pakistan’s long war against polio virus
M. Din, M. Asghar, M. Ali
Pages 1-2

Public Health Ethics
Volume 13, Issue 3, November 2020
http://phe.oxfordjournals.org/content/current

Original Articles
Against the Public Goods Conception of Public Health
Justin Bernstein, Pierce Randall
Public Health Ethics, Volume 13, Issue 3, November 2020, Pages 225–233, https://doi.org/10.1093/phe/phaa021

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

23 Dec 2020
The landscape of COVID-19 clinical trials in Latin America and the Caribbean: assessment and challenges
Current topic | English |
21 Dec 2020
Carracedo et al.
A considerable number of clinical trials is being conducted globally in response to the COVID-19 pandemic, including in low- and middle-income countries such as those in the Latin America and Caribbean region (LAC). Yet, an abundance of studies does not necessarily shorten the path to find safe and efficacious interventions for COVID-19. We analyze the trials for COVID-19 treatment and prevention that are registered from LAC countries in the International Clinical Trials Registry Platform, and identify a trend towards small repetitive non-rigorous studies that duplicate efforts and drain limited resources without producing meaningful conclusions on the safety and efficacy of the interventions being tested. We further assess the challenges to conducting scientifically sound and socially valuable research in the LAC region in order to inform recommendations to encourage clinical trials that are most likely to produce robust evidence during the pandemic.

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

Large scale use of SARS-CoV-2 antigen-based detection tests: a three-month experience in Guatemala, June-August 2020
Brief communication | English |

Social Science & Medicine
Volume 266 December 2020
https://www.sciencedirect.com/journal/social-science-and-medicine/vol/266/suppl/C

Review article Full text access
Health risks and outcomes that disproportionately affect women during the Covid-19 pandemic: A review
Jade Connor, Sarina Madhavan, Mugdha Mokashi, Hanna Amanuel, … Deborah Bartz
Article 113364