Global Health Security (GHS) Index 2021 | Advancing Collective Action and Accountability Amid Global Crisis
Authors: Jessica A. Bell; Jennifer B. Nuzzo; Nellie Bristol; Gabrielle Essix; Christopher Isaac; Amanda Kobokovich; Diane Meyer; Lucia Mullen; Sophie Rose
Date posted: December 08, 2021
Publication type: Report 268 pages
Publisher: Nuclear Threat Initiative

[Excerpt]
LEARNING FROM THE COVID-19 PANDEMIC
Nearly two years after the World Health Organization (WHO) recognized COVID-19 as a Public Health Emergency of International Concern, some lessons from the pandemic are clear:
Countries’ ability to measure the number of COVID-19 cases and deaths depend on their having public health capacities such as diagnostic and screening tests, which were not adequately established in many countries before the pandemic. For example, the WHO has estimated that six of every seven COVID-19 infections in Africa go undetected due to limited testing capacity.a As a result, official country reports of cases and deaths may not accurately reflect the full impact of COVID-19.

The availability of health security capacities in countries does not automatically translate into protection from illness, death, and economic consequence. Successful outcomes during a pandemic depend on political will and government readiness and flexibility to use available capacities in a way that aligns with evolving evidence-based public health recommendations for disease containment and mitigation. The public must trust advice from health officials and not face hurdles, such as lost income, if protective recommendations are to be followed.

National risk environments—measured by disorderly transfers of power, social unrest, international tensions, and distrust in medical and health advice from the government— can have an outsized impact on a country’s ability to successfully use its health security capacities to respond to an emerging outbreak. The success of disease-mitigation efforts is contingent upon public trust in government, healthcare institutions, and public health professionals. In the absence of trust, public cooperation and compliance with recommendations—including physical distancing, mask mandates, and shutdowns— are likely to fail and be more vulnerable to corrosive misinformation. Countries with those risk factors must develop strategies to minimize their influence—such as working to foster trust and prevent the politicization of a crisis—to enable a successful response.

Public health and health system capacities must be coupled with policies and programs that enable all people to comply with public health recommendations. Universal health coverage, paid sick leave, subsidized childcare, income assistance, and food and housing assistance are examples of policies that helped populations comply with protective public health measures of the COVID-19 pandemic. For example, Ghana and Ukraine both provide wraparound services, such as economic or medical support, to infected patients and their contacts to self-isolate or quarantine. New Zealand raised its minimum wage and began providing weekly benefits to support participation of public health measures in society. Portugal extended temporary citizenship to asylum seekers and migrants during the pandemic, thereby dismantling barriers to accessing healthcare among those populations.

See World Health Organization, “Six in Seven COVID-19 Infections Go Undetected in Africa,” October 14, 2021. https://www.afro.who.int/news/six-seven-covid-19-infections-go-undetected-africa

Media Release
2021 Global Health Security Index Finds All Countries Remain Dangerously Unprepared for Future Epidemic and Pandemic Threats
Report calls on national and global leaders to sustain and expand upon preparedness capacities developed to fight COVID-19
WASHINGTON, DC (December 8, 2021) — Despite important steps taken by countries to respond to the COVID-19 pandemic, all countries—across all income levels—remain dangerously unprepared to meet future epidemic and pandemic threats, according to the new 2021 Global Health Security (GHS) Index.

The report, released today by the Nuclear Threat Initiative (NTI) and the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health, with research by Economist Impact, measured the capacities of 195 countries to prepare for epidemics and pandemics. The data demonstrate that all countries have insufficient sustained health capacities, leaving the world acutely vulnerable to future health emergencies, including those potentially more devastating than COVID-19. The average overall 2021 GHS Index score is 38.9 out of a possible score of 100. No country scored in the top tier of rankings and no country scored above 75.9.

“COVID-19 offers a devastating illustration of how poor pandemic preparedness and response can impact health and security at every level—local, national and global,” said NTI Co-Chair and CEO Ernest J. Moniz. “The stakes are high, and world leaders need to act. Biological risks are growing in frequency, and all countries need more investment in durable capabilities to address these risks.”

The GHS Index is designed to inform leaders of the foundational elements that are necessary to prepare their countries for future outbreaks and where they should prioritize planning and durable funding. It is not a direct predictor of performance in the face of a health emergency; as COVID-19 has demonstrated—contextual social, political, and cultural phenomena also impact how well a country responds to a biological event.

“Leaders now have a choice,” said Dr. Jennifer Nuzzo, senior scholar at the Johns Hopkins Center for Health Security. “They can make dedicated, sustainable investments in the new capacities created during the COVID-19 response to prepare their countries for the long term, or they can fall back into the decades-long cycle of panic-and-neglect that will leave the world at grave risk for inevitable future public health threats.”…

ICMRA high-level meeting on global health emergencies and regulatory approaches
News 06/12/2021
On 1 and 2 December, International Coalition of Medicines Regulatory Authorities (ICMRA), a group of leading medicines regulatory authorities and experts from around the world, held a high-level meeting to discuss regulatory challenges, including those faced during the ongoing COVID-19 pandemic. Participants from the 24 members and 13 associated members and experts from the World Health Organization and the European Commission also discussed the path towards regulatory alignment on the global response to the Omicron variant.

“The pandemic has increased the urgency for us to converge on responses both to existing regulatory challenges and complex new ones,” said Emer Cooke, Chair of ICMRA and EMA’s Executive Director. “ICMRA has proven its value during the COVID-19 response, both as a platform for sharing information and best practices and as a venue for providing strategic leadership, active information sharing, pragmatic solutions and regulatory convergence.”

One of the goals of the meeting was to exchange information on regulatory approaches to the COVID-19 response, draw lessons learned and identify future priorities and opportunities to strengthen regulatory preparedness for future public health emergencies. Meeting participants also reflected on other important issues that are on the agenda of medicines regulators and public health bodies, including the fight against antimicrobial resistance, medicines for use in pregnancy and supply chain integrity.

The meeting was hosted by the Brazilian National Health Surveillance Agency (ANVISA) and co-chaired by Antonio Barra Torres, Director of ANVISA, and Emer Cooke, Chair of ICMRA and EMA’s Executive Director. A meeting report summarising the outcomes of the discussions will be published on the ICMRA website in due course.

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ICMRA Statement on Need for Continued Focus on COVID-19 Therapeutics
07 December 2021
ICMRA presents this statement to highlight the significance of the continued need for development of additional therapeutics to treat and prevent COVID-19.

Since the World Health Organization’s declaration of the pandemic in March 2020, remarkable advances in health product development have made a significant impact against COVID-19. These advances include the development and marketing of several new testing devices, numerous disinfectants and sanitizers, different types of personal protective equipment, a variety of products to assist patients in hospitals and intensive care units (ICU), some new treatments, and a number of new vaccines. While several vaccines have been successfully brought to market and are currently being deployed globally, with several others under development, more efforts are needed to increase the availability of and access to effective treatments across the disease spectrum.

The International Coalition of Medicines Regulatory Authorities (ICMRA) has been convening since the beginning of the pandemic to share information, discuss scientific requirements for the development of drugs and vaccines for COVID-19, and develop aligned regulatory approaches. ICMRA has hosted workshops and issued several statements to assist regulators, industry, healthcare professionals, patients, and other stakeholders through the pandemic, including a statement on the need to conduct well-designed clinical trials for vaccines and treatments, to support regulatory decision-making.

Building on the actions taken to-date, ICMRA, through international collaboration, pledges to continue the efforts towards developing new therapeutics for COVID-19. This is especially important in order to have treatment options for people who are unable to be vaccinated or who have lower immune response to vaccines (e.g., people who are immunocompromised), and to address issues such as break-through infections, the emergence of SARS-CoV-2 variants with some level of vaccine resistance, and waning immunity. For these reasons, there is an ongoing need for safe, effective and accessible treatments to complement vaccination.

Some advancements have been made with small molecules, including antivirals and glucocorticoids, to treat severe disease and monoclonal antibodies for prophylaxis or to treat mild-to-moderate COVID-19 in non-hospitalized patients. Many of these treatments have become available in several countries.  While these treatments are helpful, all may require parenteral (intravenous or subcutaneous) administration and/or specialized healthcare settings to monitor for adverse events. This necessitates additional treatments with ease of administration and accessibility. Recent advancements in oral antivirals for mild-to-moderate infection are encouraging, and may help fulfill the unmet need for easily accessible options.  Furthermore, the entire spectrum of COVID-19 illness could benefit from new treatments (including prevention, early mild-to-moderate disease in non-hospitalized patients, severe disease in hospitalized and ICU patients, and for patients with long-COVID symptoms).

ICMRA calls on researchers, industry, healthcare professionals, health research funding agencies, research institutions, and others to focus development efforts on therapeutics addressing the full spectrum of the COVID-19 disease in all populations and in particular, including underrepresented or underserved populations such as pediatric patients and pregnant individuals. SARS-COV-2 variants of concern should be prominently addressed in these efforts. ICMRA encourages that application for use in low and middle-income countries, also be a focus in the development of antivirals and other treatments that are safe, effective and easy to deploy.

As expressed in previous statements, ICMRA encourages collaboration to ensure the design of robust clinical trials that can deliver actionable results, with prioritisation of therapeutics with a high probability of success. Additionally, ICMRA will continue to support ongoing and sustained international collaboration on pharmacovigilance and post-approval systems to equip regulators with data and information that supports well-informed and timely action.

FDA News Release
Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals
December 08, 2021
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).

The product is only authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2. The authorization also requires that individuals either have:
:: moderate to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination (examples of such medical conditions or treatments can be found in the fact sheet for health care providers) or;
:: a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines, therefore vaccination with an available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended.

“Vaccines have proven to be the best defense available against COVID-19. However, there are certain immune compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and therefore cannot receive one and need an alternative prevention option,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Today’s action authorizes the use of the combination of two monoclonal antibodies to reduce the risk of developing COVID-19 in these individuals.”…

Coronavirus [COVID-19] – WHO
Public Health Emergency of International Concern (PHEIC)
https://www.who.int/emergencies/diseases/novel-coronavirus-2019

Weekly Epidemiological and Operational updates
Last update: 10 Dec 2021
Confirmed cases :: 267 865 289 [263 563 622 week ago]
Confirmed deaths :: 5 285 888 [5 232 562 week ago]
Vaccine doses administered: 8 158 815 265 [7 864 123 038 week ago]

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Weekly epidemiological update on COVID-19 – 7 December 2021
WHO
Overview
Globally, weekly COVID-19 case incidence plateaued this week (29 November – 5 December 2021), with over 4 million confirmed new cases reported, similar to the number reported in the previous week’s figures. However, new weekly deaths increased by 10% as compared to the previous week, with over 52 500 new deaths reported. As of 5 December, nearly 265 million confirmed cases and over 5.2 million deaths have been reported globally.
In this edition a special focus update is provided on SARS-CoV-2 Variants of Concern (VOCs) and Variants of Interest (VOIs)
An update on Variant of Concern Omicron is also provided and  includes the current situation in terms of the epidemiology and transmissibility, clinical severity, risk of reinfection and potential impact on diagnostics, vaccines and therapeutics. As our understanding of the Omicron variant is evolving, these updates will continue as further evidence becomes available.

WHO Director General Speeches [selected]
https://www.who.int/director-general/speeches
Selected
9 December 2021
Speech
WHO Director-General’s opening remarks Global Health Landscape Symposium – 9 December 2021

9 December 2021
Speech
WHO Director-General’s opening remarks at the 8th meeting of the Access to COVID-19 Tools Accelerator Facilitation Council – 9 December 2021

8 December 2021
Speech
WHO Director-General’s opening remarks at the media briefing on COVID-19 – 8 December 2021
:: The Omicron variant has now been reported in 57 countries, and we expect that number to continue growing. Certain features of Omicron, including its global spread and large number of mutations, suggest it could have a major impact on the course of the pandemic. Exactly what that impact will be is still difficult to know.
:: Any complacency now will cost lives. Many of those who don’t die could be left battling long COVID, or post-COVID condition, a disease with debilitating, lingering symptoms that we are only beginning to understand.
:: New data are emerging every day, but scientists need time to complete studies and interpret the results. We must be careful about drawing firm conclusions until we have a more complete picture. Every day, WHO is convening thousands of experts around the world to share and analyse data and drive research forward.  

6 December 2021
Speech
WHO Director-General’s opening remarks at the Stakeholder Engagement Event: Progress made so far on implementing the partnerships for vaccine manufacturing in Africa

6 December 2021
Speech
WHO Director-General’s opening remarks at the USAID Development Ministerial on COVID-19

Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 11 November 2021
For 24 vaccine candidates, presents Manufacturer, Name of Vaccine, NRA of Record, Platform, EOI Accepted Status, Pre-submission Meeting Held Status, Dossier Accepted for Review, Status of Assessment; Anticipated/Completed Decision Date
[Full scale view available at title link above]

COVID Vaccine Developer/Manufacturer Announcements
[relevant press releases/announcement from organizations from WHO EUL/PQ listing above]

AstraZeneca
Press Releases
Evusheld (formerly AZD7442) long-acting antibody combination authorised for emergency use in the US for pre-exposure prophylaxis (prevention) of COVID-19
08 December 2021

Bharat Biotech
Press Releases – No new digest announcements identified

BioCubaFarma – Cuba
Últimas Noticias – [Website not responding at inquiry; receiving 403-Forbidden]

CanSinoBIO
News – [Website not responding at inquiry]

Clover Biopharmaceuticals – China
News – No new digest announcements identified
Clover Signs COVID-19 Vaccine Supply Agreement with UNICEF
Dec 7,2021

UNICEF signs supply agreement for Clover COVID-19 vaccine
NEW YORK/COPENHAGEN, 7 December 2021 – UNICEF and Clover Biopharmaceuticals Ltd. have signed a long-term agreement for the supply of the Clover COVID-19 vaccine on behalf of the COVAX Facility.
Through the supply agreement, UNICEF will have access to up to 414 million doses of Clover’s COVID-19 vaccine until the end of 2022. These doses were committed to the COVAX Facility through an Advance Purchase Agreement (APA) signed between Gavi, the Vaccine Alliance and Clover Biopharmaceuticals on 30 June 2021. The vaccine will be supplied to participating countries and territories in the COVAX Facility’s Advance Market Commitment (AMC), as well as self-financing participants…

Curevac [Bayer Ag – Germany]
News – No new digest announcements identified

Gamaleya National Center
Latest News and Events – No new digest announcements identified [See Russia/RFID below]

IMBCAMS, China
Home – No new digest announcements identified

Janssen/JNJ
Press Releases
Dec 09, 2021 United States
World Health Organization Strategic Advisory Group of Experts (SAGE) Interim Recommendation Supports Use of Johnson & Johnson COVID-19 Vaccine as a Booster

Dec 07, 2021 United States
Janssen Announces Respiratory Syncytial Virus (RSV) Adult Vaccine Candidate Maintains High Efficacy Regardless of Lower Respiratory Tract Disease Severity

Dec 05, 2021 United States
Johnson & Johnson COVID-19 Booster, Administered Six Months After Two-Dose Regimen of BNT162b2, Shows Substantial Increase in Antibody and T-cell Responses

Moderna
Press Releases
December 10, 2021
Moderna Announces Additional 20 Million Doses of COVID-19 Vaccine to COVAX for Supply in 2021 and New Additional Supply Agreement for 2022

December 10, 2021
Moderna Announces Positive Interim Phase 1 Data for mRNA Flu Vaccine and Provides Program Update

Novavax
Press Releases – No new digest announcements identified

Pfizer
Recent Press Releases
12.09.2021
Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older

12.08.2021
Pfizer and BioNTech Provide Update on Omicron Variant

Sanofi Pasteur
Press Releases – No new digest announcements identified

Serum Institute of India
NEWS & ANNOUNCEMENTS – No new digest announcements identified

Sinopharm/WIBPBIBP
News – No new digest announcements identified

Sinovac
Press Releases – No new digest announcements identified

Vector State Research Centre of Viralogy and Biotechnology
Home – No new digest announcements identified

Zhifei Longcom, China
[Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.]
[No website identified]

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GSK
Press releases for media
07 December 2021 Medicago and GSK announce positive Phase 3 efficacy and safety results for adjuvanted plant-based COVID-19 vaccine candidate
:: Primary endpoints and secondary endpoints for which data are available were met in trial dominated by COVID-19 variants
:: Efficacy demonstrated against all variants seen in the study, including 75.3% efficacy against COVID-19 of any severity caused by the globally dominant Delta variant
:: Vaccine candidate was well-tolerated, with no related serious adverse events reported in the vaccine group
:: Final regulatory submission to be filed with Health Canada imminently

07 December 2021 Preclinical studies demonstrate sotrovimab retains activity against the full combination of mutations in the spike protein of the Omicron SARS-CoV-2 variant

Merck
News releases
Merck Announces Pause in Enrollment for Two Phase 3 Clinical Trials of Investigational, Once-Monthly, Oral Islatravir for Pre-Exposure Prophylaxis (PrEP) of HIV-1 infection
December 06, 2021

Novartis
News – No new digest announcements identified

SK Biosciences
Press releases – No new digest announcements identified

Valneva
Press Releases
December 8, 2021
Valneva Signs Advance Purchase Agreement with Bahrain for Inactivated COVID-19 Vaccine VLA2001

UNICEF COVID-19 Vaccine Market Dashboard :: Agreements Table Accessed 11 Dec 2021
An overview of information collected from publicly announced bilateral and multilateral supply agreements [no new agreements since 10/22/2021 reported]

IMF-WHO Vaccine Supply Forecast Dashboard
Updated on 22 November 2021
Many countries are not on track to meet the 40% vaccine coverage target. To make progress towards this target, we must identify: (1) Where and in which countries are the gaps?, and (2) How can gaps the be addressed?
The IMF-WHO COVID-19 Vaccine Supply Forecast Dashboard estimates expected month vaccine supply until the end of 2021 by country, product and channel. The tracker builds on the work of the IMF Staff Discussion Note – A Proposal to End the COVID-19 Pandemic (Agarwal and Gopinath, 2021).

Duke – Launch and Scale Speedometer
The Race for Global COVID-19 Vaccine Equity
A flurry of nearly 200 COVID-19 vaccine candidates are moving forward through the development and clinical trials processes at unprecedented speed; more than ten candidates are already in Phase 3 large-scale trials and several have received emergency or limited authorization. Our team has aggregated and analyzed publicly available data to track the flow of procurement and manufacturing and better understand global equity challenges. We developed a data framework of relevant variables and conducted desk research of publicly available information to identify COVID vaccine candidates and status, deals and ongoing negotiations for procurement and manufacturing, COVID burden by country, and allocation and distribution plans. We have also conducted interviews with public officials in key countries to better understand the context and challenges facing vaccine allocation and distribution
[accessed 24 July 2021]
See our COVID Vaccine Purchases research
See our COVID Vaccine Manufacturing research
See our COVID Vaccine Donations & Exports research

Global Dashboard on COVID-19 Vaccine Equity
The Dashboard is a joint initiative of UNDP, WHO and the University of Oxford with cooperation across the UN system, anchored in the SDG 3 Global Action Plan for Healthy Lives and Well-being for All.

Dashboard on Vaccine Equity [accessed 11 Dec 2021]: https://data.undp.org/vaccine-equity/
See also visualization on Vaccine Access and Vaccine Affordability
–

COVID Vaccines – OCHA:: HDX

COVID-19 Data Explorer: Global Humanitarian Operations
COVID-19 Vaccine Roll-out
11 Dec 2021 | COVAX (WHO,GAVI,CEPI), UNDESA, Press Reports | DATA
Global COVID-19 Figures: 268M total confirmed cases; 5.3M total confirmed deaths
Global vaccines administered: 8.035B
Number of Countries: 30 [30 week ago]
COVAX Allocations Round 4-9 (Number of Doses): 220M [220M week ago]
COVAX Delivered (Number of Doses): 180M [180M week ago]
Other Delivered (Number of Doses): 300M [300M week ago]
Total Delivered (Number of Doses): 480M [480M week ago]

Multilateral Leaders Task Force on COVID-19 [IMF, World Bank Group, WHO, WTO]
https://data.covid19taskforce.com/data
A global effort to help developing countries access and deliver COVID-19 vaccines, testing, and therapeutics, as they work to end the pandemic and boost economic recovery.
The International Monetary Fund, World Bank Group, World Health Organization and World Trade Organization have joined forces to accelerate access to COVID-19 vaccines, therapeutics and diagnostics by leveraging multilateral finance and trade solutions, particularly in low- and middle-income countries.
Website accessed 11 Dec 2021: https://data.covid19taskforce.com/data The global view below is complemented by country-specific dashboards here.

Our World in Data
Coronavirus (COVID-19) Vaccinations [Accessed 11 Dec 2021]
:: 55.9% of the world population has received at least one dose of a COVID-19 vaccine.
:: 8.41 billion doses have been administered globally, and 34.49 million are now administered each day.
:: Only 7.1% of people in low-income countries have received at least one dose.

U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

FDA
Press Announcements
December 10, 2021 – Coronavirus (COVID-19) Update: December 10, 2021

December 9, 2021 – Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds

December 8, 2021 – Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals

December 7, 2021 – Coronavirus (COVID-19) Update: December 7, 2021

December 7, 2021 – FDA In Brief: FDA Takes New Steps Aimed at Advancing Development of Individualized Medicines to Treat Genetic Diseases

Vaccines and Related Biological Products Advisory Committee– FDA
https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-products-advisory-committee
No meetings on calendar

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White House [U.S.]
Briefing Room – Selected Major COVID Announcements
Remarks by President Biden in Meeting with Members of the White House COVID-⁠19 Response Team on the Omicron Variant
December 09, 2021 • Speeches and Remarks

Press Briefing by White House COVID-⁠19 Response Team and Public Health Official
December 07, 2021 • Press Briefings

U.S. Department of State
https://www.state.gov/coronavirus/releases/
Media Notes
Press Statement
Administrator Samantha Power at the Development Ministerial on COVID-19
December 6, 2021
…For the past year, the story of COVID-19 around the world has been a struggle for vaccine equity—rich nations replete with doses while poorer nations fought to secure vaccines for their people. But thanks to the efforts of many many people and many institutions and nations including the United States, thanks to the tireless work of COVAX, the African Union, and other regional leaders, that story is now changing fast.

Over the past year, the United States has committed 1.2 billion vaccines to partner countries and delivered more than 290 million of those. We have invested in vaccine production capacity in countries like India, South Africa, and Senegal, so that in the future, fewer people would have to depend on vaccine donations from wealthy countries. All of this has been done with no strings attached or expectations—we do it because it is the right thing to do but it is also, we know, the smart thing to do.

Today, and this is the point I really want to stress, we are at an inflection point. The appeal from our partner nations has expanded. They are not just asking for doses; they are urging us to provide support that will allow them to administer those doses. Vaccines from some bilateral donors are finally arriving, but they are often hitting the tarmac too close to their expiration date for local health systems to distribute them. In other cases, a lack of cold chain capacity or a shortage of healthcare workers limits a country’s ability to get vaccines to those who need them.

And finally, many countries are battling a lack of confidence in vaccinations amidst misinformation and willful disinformation, a phenomenon virtually every country on earth–– including the United States––has had to confront and is confronting. As a result, despite the availability of doses, we are seeing a growing number of countries postpone or even turn them down out of concern they may not be able to get them into people’s arms.

From this day forward, I hope we can ramp up our focus and our ambition on securing not only vaccines but actual vaccinations.

This is going to require a historic mobilization—but it is one that can build on past efforts. Since COVID-19 first emerged, the United States has worked with many of you and your institutions, or nations, to help prevent the pandemic’s spread, to distribute badly needed health supplies, and encourage the uptake of vaccines. In more than 100 countries, the U.S. Government has spent more than $950 million to help supply countries with everything from the ultra-cold freezers they need to keep vaccines at subzero temperatures to the refrigerated trucks needed to get them where they need to go. We’ve also trained health workers to give shots and monitor for outbreaks, and designed public information campaigns that help fight rumors and build the confidence needed to overcome vaccine hesitancy…

Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

European Medicines Agency
News & Press Releases
News: International regulators stress continued need for COVID-19 therapeutics (new)
Last updated: 10/12/2021

News: EMA and ECDC recommendations on heterologous vaccination courses against COVID-19 (new)
Last updated: 07/12/2021
[See Perspectives above for detail]

News: ICMRA high-level meeting on global health emergencies and regulatory approaches (new)
Last updated: 06/12/2021

News: EMA recommends approval for use of RoActemra in adults with severe COVID-19 (new)
CHMP, Last updated: 06/12/2021

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European Centre for Disease Prevention and Control
https://www.ecdc.europa.eu/en
Latest Updates
Publication & Data
Epidemiological update: Omicron variant of concern (VOC) – data as of 11 December 2021 (12:00)
Epidemiological update
11 Dec 2021
As of 11 December 2021, 732 confirmed cases of SARS-CoV-2 Omicron variant of concern (VOC) cases have been reported in the European Union and European Economic Area (EU/EEA).
Confirmed cases have been reported by 22 countries: Austria (17), Belgium (30), Croatia (3), Czechia (5), Cyprus (3), Denmark (195), Estonia (15), Finland (20), France (59), Germany (77), Greece (3), Iceland (20), Ireland (6), Italy (13), Latvia (5), Liechtenstein (1), the Netherlands (62), Norway (109), Portugal (49), Romania (3), Spain (14), and Sweden (23), according to information from public sources. One new country (Cyprus) has reported SARS-CoV-2 Omicron variant of concern (VOC) cases since yesterday and in addition, a number of probable cases are reported in several countries….

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Accessed 11 Dec 2021
https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab

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European Commission
https://ec.europa.eu/commission/presscorner/home/en
No new digest content identified.

Africa: COVID-19 – Announcements/Regulatory Actions/Deployment

Accessed 11 Dec 2021. Full scale, interactive dashboard available at:
https://africacdc.org/covid-19-vaccination/

Russia: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

Russia: Sputnik V – “the first registered COVID-19 vaccine”
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
Recommendations of EMA and ongoing combo studies support mix&match approach pioneered by Sputnik team to fight COVID
Press release, 07.12.2021

RDIF ready to provide the one-shot Sputnik Light vaccine and Sputnik M vaccine (for adolescents) as it develops strategic cooperation with partners in India to fight COVID
Press release, 06.12.2021
Moscow, December 6, 2021 – Partnership between Russia and India in the fight against COVID has already demonstrated significant results, and the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) strives to expand it through providing the one-shot Sputnik Light vaccine and Sputnik M vaccine (for adolescents).
… RDIF has also provided India’s regulator with documents for registration of Sputnik M – the vaccine for adolescents aged 12-17. Russia’s Health Ministry registered Sputnik M on November 24, 2021. It has become a new member of the Sputnik vaccines family and is offered to international markets joining Sputnik V and Sputnik Light.
Subject to positive decision of India’s authorities, Sputnik M could become the first foreign registered vaccine for adolescents in the country and make an important contribution in protecting the younger population….

The one-shot Sputnik Light vaccine authorized in Argentina as a standalone vaccine and a booster shot
Press release, 06.12.2021

Saudi Arabia has joined more than 100 countries accepting visitors vaccinated with Sputnik V following extensive work between Ministry of Health of Saudi Arabia and RDIF, supported by the Ministry of Investments of Saudi Arabia
Press release, 05.12.2021

India: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

Ministry of Health and Family Welfare
https://www.mohfw.gov.in/

Government of India – Press Information Bureau
Latest Press Releases
COVID-19 Vaccination Update – Day 330
:: India’s cumulative vaccination coverage reaches nearly 133 Crore
:: More than 81 lakh Vaccine doses administered today till 7 pm
Posted On: 11 DEC 2021 8:11PM by PIB Delhi

Indian Council for Medical Research (ICMR)
https://www.icmr.gov.in/media.html
Press Releases
No new digest content identified.

China: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

National Health Commission of the People’s Republic of China [to 11 Dec 2021]
http://en.nhc.gov.cn/
News
Dec 11: Daily briefing on novel coronavirus cases in China
On Dec 10, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 87 new cases of confirmed infections.

Beijing administers over 2m COVID-19 vaccine doses to children
2021-12-10
BEIJING — As of 4 pm Wednesday, more than 2 million doses of COVID-19 vaccines had been administered in Beijing to the city’s children aged between 3 and 11, local authorities said on Dec 9.
Starting from Oct 28, the Chinese capital began offering COVID-19 vaccination to children aged between 3 and 11. Nearly 1.37 million minors of this age group have been vaccinated.

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)
https://polioeradication.org/polio-today/polio-now/this-week/

Polio this week as of 08 December 2021
:: An updated version of the nOPV2-cVDPV2 fact sheet has been released in English and French.

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
–  Afghanistan: one WPV1 case
–  Cameroon: one cVDPV2 case and one positive environmental sample
–  Nigeria: 18 cVDPV2 cases and 15 positive environmental samples

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WHO/OCHA Emergencies

Health emergencies list – WHO
“The health emergencies list details the disease outbreaks, disasters and humanitarian crises where WHO plays an essential role in supporting countries to respond to and recover from emergencies with public health consequences.”
Afghanistan crisis [Last apparent update: 18 Oct 2021]

Crisis in Northern Ethiopia [Last apparent update: 1 June 2021]

Ebola outbreak, Democratic Republic of the Congo, 2021 [Last apparent update: 17 Aug 2021]

Ebola outbreak outbreak, N’Zerekore, Guinea, 2021 [Last apparent update: 17 Aug 2021]

Coronavirus disease (COVID-19) pandemic [See COVID above]

Ebola outbreak, Equateur Province, Democratic Republic of the Congo, 2020
[Last apparent update: 17 Aug 2021]

Ebola outbreak, North Kivu, Ituri, Democratic Republic of the Congo, 2018 – 2020
[Last apparent update: 17 Aug 2021]

Ebola outbreak, Democratic Republic of the Congo, 2018 [Last apparent update: 24 July 2018]

Yemen crisis [Last apparent update: 12 February 2021]

Syria crisis [Last apparent update: 18 June 2021]

Somalia crisis [Last apparent update: 24 March 2018]

Nigeria crisis [Last apparent update: 1 Oct 2021]

Ebola outbreak, Democratic Republic of the Congo, 2017 [Last apparent update: 17 Aug 2021]

Zika virus disease outbreak, 2015-2016 [Last apparent update: 24 Jan 2020]

Ebola outbreak: West Africa, 2014-2016 [Last apparent update: 17 Aug 2021]

Iraq crisis [Last apparent update: 9 Jan 2008]

South Sudan crisis [Last apparent update: 23 Sep 2020]

Avian influenza A (H7N9) virus outbreak [Last apparent update: 13 September 2021]

Middle East respiratory syndrome (MERS-CoV) outbreak [Last apparent update: 8 July 2019]

Influenza A (H1N1) virus, 2009-2010 pandemic [Last apparent update: 10 Aug 2010]

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UN OCHA – Current Emergencies
Current Corporate Emergencies
Afghanistan
Afghanistan: ICCT Real-Time Response Overview Situation Report (8 December 2021)
HIGHLIGHTS
:: Humanitarians seek US$606 million as part of the Flash Appeal to provide prioritised multi-sectoral assistance to 11 million people in the four remaining months of 2021. As at 7 December, the Flash Appeal is now over 100 per cent funded. While humanitarians remain grateful for the generous contribution by the donor community, all commitments have not been translated to actions on the ground as partners continue to face liquidity challenges amid the financial system crisis. The absence of these challenges would enable humanitarian partners to further scale up the response at a higher pace and reach more people in need of assistance…

Northern Ethiopia
Ethiopia – Northern Ethiopia Humanitarian Update Situation Report, 9 Dec 2021

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WHO & Regional Offices [to 11 Dec 2021]
https://www.who.int/
Selected News, Statements
10 December 2021
News release
Two decades dedicated to capacity building for health emergency preparedness and response

9 December 2021
Highlights
Quality of HIV Care: from guidance to implementation

9 December 2021
News release
WHO and Global Fund warn inequalities block progress towards ending AIDS, TB and malaria

9 December 2021
Departmental news
WHO works to scale-up support to low- and middle-income countries (LMICs) to address antimicrobial resistance (AMR) thanks to support from the Kingdom of Saudi Arabia

9 December 2021
Departmental news
Updated interim recommendations for the use of the Janssen Ad26.COV2.S (‎COVID-19)‎ vaccine

9 December 2021
Statement
WHO continues to support its conditional recommendation for the dapivirine vaginal ring as an additional prevention option for women at substantial risk of HIV

9 December 2021
Departmental news
Neglected tropical diseases: WHO launches survey to expand its offer of online training courses

8 December 2021
Departmental news
Health in the World of Work

8 December 2021
Departmental news
New partnership to combat antimicrobial resistance in gonorrhoea

8 December 2021
Departmental news
Schistosomiasis and soil-transmitted helminthiases: treating millions of people, despite the pandemic

7 December 2021
Departmental news
“The public health impact of chemicals: knowns and unknowns” is now available in the Persian language

7 December 2021
News release
WHO accelerates work on nutrition targets with new commitments

7 December 2021
Departmental news
The Collective Service: supporting RCCE in emergencies

7 December 2021
News release
WHO recommends against the use of convalescent plasma to treat COVID-19

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Weekly Epidemiological Record, Vol. 96, No. 49, pp. 597–612 10 December 2021
:: Rapid COVID-19 vaccination roll-out among indigenous populations in Brazil
:: Update on vaccine-derived poliovirus outbreaks– worldwide, January 2020–
June 2021

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: 09 December 2021 Omicron spreads but severe cases remain low in South Africa
:: 08 December 2021 COVID-19 pandemic slows progress against tuberculosis
:: 07 December 2021 Africa cuts HIV infections, deaths but key targets still elusive

WHO Region of the Americas PAHO
No new digest content identified

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

WHO European Region EURO
:: Providing urgent health care to migrants in Belarus 10-12-2021
:: Contact tracing during a pandemic: Gintare’s story from Lithuania 10-12-2021
:: Recognizing health and care workers in the WHO European Region 10-12-2021

WHO Eastern Mediterranean Region EMRO
:: Omicron VOC questions and answers
:: Universal Health Coverage Day, 12 December 9 December 2021
:: WHO donates 260 000 packs of intravenous solutions to Islamic Republic of Iran 6 December 2021
:: King Salman Humanitarian Aid and Relief Centre provides lifeline for millions across Yemen 5 December 2021

WHO Western Pacific Region
:: 8 December 2021 Six ways to protect yourself and those around you during the holiday season

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WHO Events
https://www.who.int/news-room/events/2
[Selected]
WHO STI Research Priority Setting Technical Advisory Group
14 December 2021 18:00 – 19:00 UTC Time

Global expenditure on health: Public spending on the rise?
15 December 2021 14:00 – 15:30 UTC Time

WHO Global Competency Standards for Refugee and Migrant Health Services – Strengthening the health workforce to provide quality health services to refugees and migrants
16 December 2021 14:00 – 15:00 CET

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New WHO Publications
https://www.who.int/publications/i
Selected Titles
9 December 2021
State of inequality: HIV, tuberculosis and malaria
[See Perspectives above for detail]

9 December 2021
Annexes to the interim recommendations for use of the Janssen Ad26.COV2.S vaccine

9 December 2021
Interim recommendations for the use of the Janssen Ad26.COV2.S (COVID-19) vaccine

8 December 2021
WHO Human Health Risk Assessment Toolkit: Chemical Hazards, second edition

8 December 2021
Addressing violence against women in health and multisectoral policies: a global status report

7 December 2021
Food systems for health: information brief

7 December 2021
Therapeutics and COVID-19
Overview
The WHO Therapeutics and COVID-19: living guideline contains the Organization’s most up-to-date recommendations for the use of therapeutics in the treatment of COVID-19. The latest version of this living guideline is available in pdf format (via the ‘Download’ button) and via an online platform, and is updated regularly as new evidence emerges.
This seventh version of the WHO living guideline now contains 11 recommendations, including two new recommendations regarding convalescent plasma. No further updates to the previous existing recommendations were made in this latest version…

7 December 2021
Interim recommendations for use of the Moderna mRNA-1273 vaccine against COVID-19

6 December 2021
COVID-19 and the social determinants of health and health equity: evidence brief

6 December 2021
World malaria report 2021

6 December 2021
Sexual and reproductive health and rights: Infographic snapshot

6 December 2021
Towards developing WHO’s agenda on well-being

6 December 2021
Health Promotion Glossary of Terms 2021

6 December 2021
Enhancing uptake of voluntary medical male circumcision among adolescent boys and men at higher risk…

6 December 2021
Safeguarding the future: giving priority to the needs of adolescent and young mothers living with HIV

6 December 2021
Workshop on external competence assessment and national competence assessment for malaria microscopists…

6 December 2021
Sixth Meeting of the WHO South-East Asia Regional Verification Commission for measles and rubella

CDC/ACIP [U.S.] [to 11 Dec 2021]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements [Selected]
CDC Expands COVID-19 Booster Recommendations to 16-and-17-year-olds Thursday, December 9, 2021
“Today, CDC is strengthening its booster recommendations and encouraging everyone 16 and older to receive a booster shot. Although we don’t have all the answers on the Omicron variant, initial data suggests that COVID-19 boosters help broaden and strengthen the protection against Omicron and other variants. We know that COVID-19 vaccines are safe and effective, and I strongly encourage adolescents ages 16 and 17 to get their booster if they are at least 6 months post their initial Pfizer vaccination series.”

CDC Launches Two Global Networks, Awards $22 Million to Combat Antimicrobial Resistance and Infectious Diseases Tuesday, December 7, 2021

Transcript: New Vital Signs Report The HIV epidemic remains severe among gay and bisexual men – What can be done to end the epidemic for everyone? Tuesday, December 7, 2021

ACIP Meetings
No new meetings listed.

MMWR News Synopsis Friday, December 3, 2021
Selected Content
:: Symptoms of Depression, Anxiety, Post-Traumatic Stress Disorder, and Suicidal Ideation Among State, Tribal, Local, and Territorial Public Health Workers During the COVID-19 Pandemic — United States, March–April 2021
:: Vital Signs: HIV Infection, Diagnosis, Treatment, and Prevention Among Gay, Bisexual, and Other Men Who Have Sex with Men — United States, 2010–2019
:: Correction and Republication: Symptoms of Depression, Anxiety, Post-Traumatic Stress Disorder, and Suicidal Ideation Among State, Tribal, Local, and Territorial Public Health Workers During the COVID-19 Pandemic — United States, March–April 2021

Coronavirus Disease 2019 (COVID-19)– CDC
Approximately 25 announcements/reports/data summaries.
:: 12/11/21 Omicron Variant: What You Need to Know
:: 12/10/21 EARLY RELEASE: Booster and Additional Primary Dose COVID-19 Vaccinations Among Adults Aged ≥65 Years — United States, August 13, 2021–November 19, 2021

Africa CDC [to 11 Dec 2021]
http://www.africacdc.org/
News
Press Releases
Progress made so far in implementing the Partnerships for African Vaccine Manufacturing (PAVM) – Framework for Action. Kigali, Rwanda, 06-07 December 2021
Kigali, 06 December 2021. The 39th Ordinary Session of the African Union’s Executive Council decision EX.CL/Dec. 1129 (XXXIX) recognized the Partnerships for African Vaccine Manufacturing PAVM as the coordinating mechanism and its leadership of the development of a continental vaccine manufacturing strategy and a framework for action. The Africa Centres for Disease Control and Prevention (Africa CDC) and its partners have led the establishment of the PAVM with a clear mandate, operating model and governance structure. The four core mandates of the PAVM are to:
Steward a continental strategy that maintains scale and cost-competitiveness of local manufacturing and promotes equity and security for all
Support partnerships to create a conducive business environment that will encourage the emergence of a thriving manufacturing base
Play intermediation and partner role between Member States and the global community of supporters on an as-needed basis
Communicate updates and serve as the central source of information for Africa vaccine manufacturing

China CDC http://www.chinacdc.cn/en/

National Health Commission of the People’s Republic of China [to 11 Dec 2021]
http://en.nhc.gov.cn/
News
Dec 11: Daily briefing on novel coronavirus cases in China
On Dec 10, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 87 new cases of confirmed infections.

Beijing administers over 2m COVID-19 vaccine doses to children
2021-12-10
BEIJING — As of 4 pm Wednesday, more than 2 million doses of COVID-19 vaccines had been administered in Beijing to the city’s children aged between 3 and 11, local authorities said on Dec 9.
Starting from Oct 28, the Chinese capital began offering COVID-19 vaccination to children aged between 3 and 11. Nearly 1.37 million minors of this age group have been vaccinated.
Children between 3 and 11 can only be inoculated under the condition that their guardians have been well-informed and offer their voluntary consent…

National Medical Products Administration – PRC [to 11 Dec 2021]
http://english.nmpa.gov.cn/
News
Over 2.57b COVID-19 vaccine doses administered on Chinese mainland
2021-12-10
Over 2.57 billion COVID-19 vaccine doses had been administered on the Chinese mainland as of Wednesday, data from the National Health Commission showed on Dec 9.

Antibody combination therapy approved to treat COVID-19
2021-12-10
China approved on Dec 8 the use of a monoclonal neutralizing antibody cocktail for COVID-19 treatment created by Brii Biosciences, making it the first antibody combination therapy against the disease to get the green light in the country.

CCDC Weekly – Weekly Reports: Current Volume (3)
2021-12-10 / No. 50 COVID-19 ISSUE (21)
View  PDF of this issue
Perspectives: On Coexistence with COVID-19: Estimations and Perspectives
Perspectives: Papua New Guinea Under the COVID-19 Pandemic and Public Health Support from the World Health Organization
Outbreak Reports: Exploring the Bridge Cases’ Role in the Transmission of the SARS-CoV-2 Delta Variant — Ruili City, Yunnan Province, China, July–September 2021
Methods and Applications: Feasibility of Booster Vaccination in High-Risk Populations for Controlling Coronavirus Variants — China, 2021
Notes from the Field: Whole-Genome Sequences Analysis Displays Relationship of SARS-CoV-2 Delta Variant Between Four Local Cases and Passengers of a Flight from South Africa — Shenzhen City, Guangdong Province, China, June 2021

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Organization Announcements
Editor’s Note:
Careful readers will note that the number and range of organizations now monitored in our Announcements section below has grown as the impacts of the pandemic have spread across global economies, supply chains and programmatic activity of multilateral agencies and INGOs.
 
 
Paul G. Allen Frontiers Group [to 11 Dec 2021]
https://alleninstitute.org/news-press/
News
No new digest content identified.
 
 
BARDA – U.S. Department of HHS [to 11 Dec 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
News
December 08, 2021: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals

December 03, 2021: FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns
 
 
BMGF – Gates Foundation [to 11 Dec 2021]
https://www.gatesfoundation.org/ideas/media-center
Press Releases and Statements
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute [to 11 Dec 2021]
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 11 Dec 2021]
https://carb-x.org/
News
No new digest content identified.
 
 
Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 11 Dec 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
:: Past weekly editions and posting of all segments of Vaccines and Global Health: The Week in Review are available here.
:: Informed Consent: A Monthly Review – December 2021 is now posted here
 
 
CEPI – Coalition for Epidemic Preparedness Innovations [to 11 Dec 2021]
http://cepi.net/
Latest News
Gritstone bio and CEPI expand vaccine agreement to tackle Omicron variant
06 December, 2021; Emeryville, California and Oslo, Norway—Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, and CEPI, the Coalition for Epidemic Preparedness Innovations, today announced the expansion of their agreement in order to support the development of a self-amplifying mRNA (SAM) vaccine designed to tackle the Omicron COVID-19 variant. CEPI will provide up to $5 million in additional funding to conduct a Phase 1 clinical trial of Gritstone’s Omicron vaccine candidate in South Africa, where a CEPI-funded clinical trial of Gritstone’s Beta variant COVID-19 vaccine is due to begin shortly. The SARS-CoV-2 T cell epitopes (TCEs) administered within Gritstone’s SAM COVID-19 vaccines are minimally impacted by mutations found within the Omicron variant, reinforcing the platform’s potential to address both Omicron and future variants of concern…
 
 
DARPA – Defense Advanced Research Projects Agency [to 11 Dec 2021
https://www.darpa.mil/news
News
12/8/2021
DARPA Successfully Transitions Synthetic Biomanufacturing Technologies to Support National Security Objectives
Launched in 2010, DARPA’s Living Foundries program aimed to enable adaptable, scalable, and on-demand production of critical, high-value molecules by programming the fundamental metabolic processes of biological systems to generate a vast number of complex molecules. These molecules were often prohibitively expensive, unable to be domestically sourced, and/or impossible to manufacture using traditional synthetic chemistry approaches. As a proof of concept, DARPA intended to produce 1,000 molecules and material precursors spanning a wide range of defense-relevant applications including industrial chemicals, fuels, coatings, and adhesives.

12/6/2021
Leveraging AI to Accelerate Development of Scientific Models
In August 2018, DARPA released its first AI Exploration (AIE) opportunity called Automating Scientific Knowledge Extraction (ASKE). Unlike DARPA’s typical four-year programs, AIEs are designed to be fast-tracked (~18 months in duration) research efforts that help determine the feasibility of an AI concept. The goal of the ASKE project was to develop AI technologies capable of automating some of the manual processes of scientific knowledge discovery, curation, and application. It identified how and where AI could accelerate the process of scientific modeling, and ultimately improve researchers’ ability to conduct rigorous and timely experimentation and validation.
 
 
Duke Global Health Innovation Center [to 11 Dec 2021]
https://dukeghic.org/
Our Blog
No new digest content identified.
 
 
EDCTP [to 11 Dec 2021]
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
News
No new digest content identified.
 
 
Emory Vaccine Center [to 11 Dec 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.
 
 
European Vaccine Initiative [to 11 Dec 2021]
http://www.euvaccine.eu/
Latest News News, Events
No new digest content identified.
 
 
Fondation Merieux [to 11 Dec 2021]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.
 
 
Gavi [to 11 Dec 2021]
https://www.gavi.org/
News Releases
10 December 2021
Gavi and Moderna reach agreement for additional supply to COVAX
:: Agreement  will make up to an additional 150 million doses of the Moderna COVID-19 vaccine available to  COVAX Facility participants in Q2 and Q3 2022, at the lowest tiered price
:: Gavi and Moderna have also agreed to advance availability of 20 million doses – originally scheduled to be available in Q1 2022 – to Q4 2021

GHIT Fund [to 11 Dec 2021]
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 11 Dec 2021]
https://www.theglobalfund.org/en/news/
News & Stories
News
WHO and Global Fund Warn Inequalities Block Progress Towards Ending AIDS, TB and Malaria
09 December 2021
[See Perspectives above for detail]
 
 
Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 11 Dec 2021]
https://www.glopid-r.org/news/
News
No new digest content identified.
 
 
Hilleman Laboratories [to 11 Dec 2021]
http://www.hillemanlabs.org/
News & Insights
Press Release
Hilleman Laboratories establishes pilot manufacturing facility for vaccine development in Singapore with support from Singapore Economic Development Board
New facility is part of first-of-its-kind vaccine development and manufacturing hub in Singapore
Singapore, 6 December 2021: Hilleman Laboratories, an organisation with a mission to develop affordable vaccines and biologics against infectious diseases, today announced a first-of-its-kind vaccine and biologics development and manufacturing hub in Singapore. Established with the support of the Singapore Economic Development Board (EDB), the hub comprises a 30,000 square foot current Good Manufacturing Practices (cGMP) facility at 138 Depot Road and a state-of-the art research and development (R&D) facility at Biopolis which began operations in April 2021. Hilleman Laboratories is investing close to SGD 80 million (USD 58 million) in operations, infrastructure and capacity building over the next five years…
 
 
HHMI – Howard Hughes Medical Institute [to 11 Dec 2021]
https://www.hhmi.org/news
Press Room
No new digest content identified
 
 
Human Vaccines Project [to 11 Dec 2021]
http://www.humanvaccinesproject.org/
News
HVP COVID Report
Dec 09, 2021
Wayne Koff: Harnessing the Power of AI to Understand Human Immunity
 
 
IAVI [to 11 Dec 2021]
https://www.iavi.org/newsroom
Latest News
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.
 
 
ICRC [to 11 Dec 2021]
https://www.icrc.org/en/whats-new
Selected News Releases, Statements, Reports
South Sudan: Looting of a health care unit during armed violence in Unity State

People wounded during the clashes have had to walk up to 30km across heavily flooded terrain to access health care following the looting of Padeah Primary Health Unit.
09-12-2021 | Statement

Dakar Forum on Peace and Security: “There can be no security without human security”
The following comments were made by Peter Maurer, president of the International Committee of the Red Cross, as part of a panel discussion on challenges to stability and emergence in Africa in a post-COVID-19 world, at the Dakar International Forum o
06-12-2021 | Statement

IFFIm
http://www.iffim.org/
Press Releases/Announcements
No new digest content identified.
 
 
IFRC [to 11 Dec 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
09/12/2021
Ethiopia: IFRC steps up emergency response amid “ove…

06/12/2021
IFRC President Francesco Rocca meets with Russian Pr…
Moscow/Geneva, 6 December 2021 – The President of the International Federation of Red Cross and Red Crescent Societies (IFRC) Francesco Rocca, met in the late afternoon of the 5th of December with the President of the Russian Federation, Vladimir Putin.
During the meeting, President Rocca discussed humanitarian priorities and challenges, such as; the COVID-19 pandemic, the equitable distribution of vaccines, the migration crisis at the border between Belarus and Poland, how to strengthen support to the Russian Red Cross, and the critical role of local actors to respond to emergencies…

06/12/2021
Indonesia: Rescue and relief critical after Mount Se…
 
 
Institut Pasteur [to 11 Dec 2021]
https://www.pasteur.fr/en/press-area
Press Documents
Press Info
01.12.2021
Virus related to SARS-CoV-2 found in bats in Cambodia
What are the origins of SARS-CoV-2? This is the world’s most pressing scientific puzzle. Its pieces scattered throughout the world are currently being sought out by scientists. Their goal: to track down the culprit for the largest health crisis to hit the globe in the past century. Scientists at the Institut Pasteur in Paris and the Institut Pasteur du Cambodge have identified a coronavirus in bats in Cambodia whose genome is 92.6% related to SARS-CoV-2. These findings were published in Nature Communications on November 9, 2021.
 
 
IOM / International Organization for Migration [to 11 Dec 2021]
http://www.iom.int/press-room/press-releases
News – Selected
News
10 Dec 2021
Rising Migrant Deaths Top 4,400 This Year: IOM Records More Than 45,000 Since 2014
 
 
ISC / International Science Council [to 11 Dec 2021]
https://council.science/current/
ISC is a non-governmental organization with a unique global membership that brings together 40 international scientific Unions and Associations and over 140 national and regional scientific organizations including Academies and Research Councils.
News
News Press releases
Researchers combat new threats to key human rights
10.12.2021
Scientists call for global science systems that protect the human right to science in a new paper published today by the International Science Council (ISC).
Report: https://stories.council.science/science-freedom-responsibility/

Press releases
Global Commission on Science Missions for Sustainability Launched
09.12.2021
Political leaders, scientists, and influential personalities issue emergency warning on sustainability inaction, establish a Global Commission to mobilize a $100 million a year global fund for Sustainability Science Missions
Commission members include former NZ PM Helen Clark, former UNESCO Director General Irina Bokova, film producer James Cameron and philanthropist Julie Wrigley
9 December 2021 Paris, France: The International Science Council (ISC) is a non-governmental organization with a unique global membership bringing together over 200 international scientific unions and associations, as well as national and regional scientific organizations, academies, and research councils. Today in Paris, its new President, Peter Gluckman, former Chief Science Adviser to the government of New Zealand, announced the ‘Global Commission on Science Missions for Sustainability’ with the sole purpose of pressing the reset button to accelerate the progress towards the Sustainable Development Goals (SDGs).
 
 
IVAC [to 11 Dec 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.
 
 
IVI [to 11 Dec 2021]
http://www.ivi.int/
IVI News & Announcements
IVI, ADB SEADS, IPK, ICARS, and the Danish Embassy in Korea launch webinar on combatting antimicrobial resistance
December 7, 2021 — The International Vaccine Institute (IVI), Asian Development Bank Southeast Asia Development Solutions (ADB SEADS), Institut Pasteur Korea (IPK), the International Centre for Antimicrobial Resistance Solutions (ICARS), and the Embassy of Denmark in Korea held a joint webinar today to bring awareness to antimicrobial resistance (AMR) and discuss sustainable solutions to the global public health threat…
 
 
Johns Hopkins Center for Health Security [to 11 Dec 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
2021 Global Health Security Index Finds All Countries Remain Dangerously Unprepared for Future Epidemic and Pandemic Threats
December 8, 2021
[See Perspectives above for detail]
 
 
MSF/Médecins Sans Frontières [to 11 Dec 2021]
http://www.msf.org/
Latest [Selected Announcements]
DRC Ebola outbreaks
DRC’s thiteenth Ebola outbreak
Crisis Update 9 Dec 2021
Following a series of community deaths in North Kivu province, Democratic Republic of Congo (DRC), the DRC Ministry of Health declared an outbreak of Ebola on 8 October. The outbreak is concentrated in Beni health zone. This is the thirteenth epidemic in DRC, the third in North Kivu province and the second in Beni health zone.
 
 
Coronavirus COVID-19 pandemic
Responding to COVID-19: Global Accountability Report 5 – May to September 2021
Report 8 Dec 2021

Kenya
Urgent solutions needed for refugees as camps set to close
Press Release 6 Dec 2021

Kenya
In search of dignity: Refugees in Kenya face a reckoning
Report 6 Dec 2021
 
 
National Academy of Medicine – USA [to 11 Dec 2021]
https://nam.edu/programs/
Selected News/Programs/Events
No new digest content identified.
 
 
National Academy of Sciences – USA [to 11 Dec 2021]
http://www.nasonline.org/news-and-multimedia/
News
No new digest content identified.
 
 
National Vaccine Program Office – U.S. HHS [to 11 Dec 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.
 
 
NIH [to 11 Dec 2021]
http://www.nih.gov/news-events/news-releases
News Releases
Experimental mRNA HIV vaccine safe, shows promise in animals
December 9, 2021 — NIH scientists developed vaccine platform.
An experimental HIV vaccine based on mRNA—the same platform technology used in two highly effective COVID-19 vaccines—shows promise in mice and non-human primates, according to scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Their results, published in Nature Medicine, show that the novel vaccine was safe and prompted desired antibody and cellular immune responses against an HIV-like virus…
 
 
OECD [to 11 Dec 2021]
http://www.oecd.org/newsroom/publicationsdocuments/bydate/
Newsroom
Portugal: use post-COVID-19 recovery plan to bolster growth and public finances, says OECD
Portugal’s economy is recovering from the COVID-19 crisis, thanks to swift and effective policy action and a successful vaccine rollout. As the recovery progresses, it is important to pursue investment and structural reforms that will raise living standards, strengthen public finances and put growth on a strong, sustainable and resilient path, according to a new OECD report.
10-December-2021

Pensions protected during COVID-19 pandemic but ageing challenges persist, says OECD
The COVID-19 pandemic has taken a heavy toll among elderly people although retirees have seen their pension payments well protected across OECD countries. Future pension entitlements have also been well protected thanks to the exceptional policy response to the crisis, according to a new OECD report.
8-December-2021
 
 
PATH [to 11 Dec 2021]
https://www.path.org/media-center/
Press Releases
No new digest content identified.
 
 
Sabin Vaccine Institute [to 11 Dec 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.
 
 
UNAIDS [to 11 Dec 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
10 December 2021
Co-creating a new global initiative to end AIDS among children, adolescents and their mothers

10 December 2021
The need for wider implementation of people-centred differentiated service delivery for HIV testing and treatment in Africa

9 December 2021
High-level continental seminar on the right to health and social protection in Africa

9 December 2021
Social protection systems addressing inequalities

8 December 2021
Empowering sex workers through social enterprises

8 December 2021
We need your thoughts and ideas on how to end AIDS among children, adolescents and mothers—new global online survey launched

8 December 2021
Leaders from Eastern and Southern Africa recommit to the education, health and well-being of adolescents and young people

7 December 2021
The importance of comprehensive sexuality education for Africa’s young people

6 December 2021
Commemorating World AIDS Day in the Central African Republic

UNHCR Office of the United Nations High Commissioner for Refugees [to 11 Dec 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected News Releases, Announcements
No new digest content identified.
 
 
UNICEF [to 11 Dec 2021]
https://www.unicef.org/media/press-releases
Press Releases, News Notes, Statements [Selected]
Press release
12/10/2021
UNICEF welcomes announcement of next Executive Director
NEW YORK, 10 December 2021 – UNICEF welcomes United Nations Secretary-General António Guterres’ announcement today that Catherine M. Russell will succeed Henrietta H. Fore as UNICEF Executive Director.
Ms. Russell brings to the role decades of experience in developing innovative policy that empowers underserved communities around the world; delivering high-impact programmes that protect women and girls, including in humanitarian crises; building, elevating, and managing diverse workforces; and mobilizing resources and political support for a broad range of initiatives.
She currently serves as Assistant to the President and Director of the White House Office of Presidential Personnel. From 2013 to 2017, she served as Ambassador-at-Large for Global Women’s Issues at the U.S. Department of State. In that post, she integrated women’s issues across all elements of U.S. foreign policy, represented the United States in more than 45 countries, and worked with foreign governments, multilateral organizations, and civil society. She was the principal architect of the ground-breaking “U.S. Global Strategy to Empower Adolescent Girls”…

Press release
12/08/2021
COVID-19 ‘biggest global crisis for children in our 75-year history’ – UNICEF
On its 75th anniversary, UNICEF warns that COVID-19 is rolling back virtually every measure of progress for children, including a staggering 100 million more children plunged into poverty

Press release
12/08/2021
More than US$27 billion committed to tackle global malnutrition and hunger crisis at the Tokyo Nutrition for Growth Summit
45 low- and middle-income countries led with strong policy and financial commitments

Press release
12/07/2021
UNICEF launches US$9.4 billion emergency funding appeal for children affected by conflict, the climate crisis and COVID-19
Funds will support essential programs for over 177 million children in need across 145 countries and territories through 2022

News note
12/07/2021
UNICEF signs supply agreement for Clover COVID-19 vaccine
NEW YORK/COPENHAGEN, 7 December 2021 – UNICEF and Clover Biopharmaceuticals Ltd. have signed a long-term agreement for the supply of the Clover COVID-19 vaccine on behalf of the COVAX Facility.
Through the supply agreement, UNICEF will have access to up to 414 million doses of Clover’s COVID-19 vaccine until the end of 2022. These doses were committed to the COVAX Facility through an Advance Purchase Agreement (APA) signed between Gavi, the Vaccine Alliance and Clover Biopharmaceuticals on 30 June 2021. The vaccine will be supplied to participating countries and territories in the COVAX Facility’s Advance Market Commitment (AMC), as well as self-financing participants.
This agreement further expands UNICEF’s COVID-19 vaccine supplier base. UNICEF has already signed supply agreements with vaccine manufacturers including the Serum Institute of India, Pfizer, AstraZeneca, Human Vaccine, Moderna, Janssen Pharmaceutica NV, Sinopharm and Sinovac. The addition of Clover’s vaccine to the portfolio provides further diversification by providing access to the first protein subunit vaccine.
Procurement by UNICEF under this agreement is conditional on the product achieving an Emergency Use Listing (EUL) from WHO, to confirm the quality, safety and efficacy of the vaccine…

Statement
12/06/2021
UNICEF and WHO, in partnership with Gavi, ask Ted Chaiban to serve as Global Lead Coordinator for COVID Vaccine Country Readiness and Delivery
NEW YORK, 6 December 2021 – “I am pleased to announce that UNICEF and WHO, in partnership with Gavi, have asked Ted Chaiban, currently UNICEF Regional Director Middle East and North Africa, to serve as Global Lead Coordinator for COVID Vaccine Country Readiness and Delivery.
“This decision is an expression of our joint commitment to reinvigorate efforts to turn vaccines into vaccinations in low- and middle-income countries.
“With vastly improved supply, the world no longer has a global vaccine supply problem; it has a vaccine equity and delivery problem. More than 80 per cent of the world’s vaccines have gone to G20 countries while millions of people, including healthcare workers, in low-income countries are still unprotected.
“As vaccine doses become increasingly available in the coming weeks, it is critical that countries are prepared, resourced and able to roll them out.
“With support from COVAX, the African Union, AVAT and other partners, governments in low-income countries have made important progress in getting ready to receive and administer COVID-19 vaccines at a scale sufficient to meet global objectives. However, they still face significant challenges in scaling up capacity….

Press release
12/06/2021
Learning losses from COVID-19 could cost this generation of students close to $17 trillion in lifetime earnings
World Bank-UNESCO-UNICEF report lays out the magnitude of the education crisis
 
 
Unitaid [to 11 Dec 2021]
https://unitaid.org/
Featured News
09 December 2021
Landscape report launched on novel technologies for the prevention of HIV, STIs, and unwanted pregnancy
Geneva – Emerging technologies that can prevent HIV, other sexually transmitted infections and unwanted pregnancies through a single administration method have the potential to respond better to user preferences, simplify service delivery, alleviate stigma, and reduce health risks. Currently, over two dozen of these tools, called multipurpose prevention technologies, are in development, demonstrating the opportunity to accelerate health impact and help achieve global health targets, according to a new landscape report jointly launched today by Unitaid, the Children’s Investment Fund Foundation, and the Initiative for Multipurpose Prevention Technologies…
 
 
Vaccine Equity Cooperative [nee Initiative] [to 11 Dec 2021]
https://vaccineequitycooperative.org/news/
News
No new digest content identified.
 
 
Vaccination Acceptance & Demand Initiative [Sabin) [to 11 Dec 2021]
https://www.vaccineacceptance.org/
Announcements
Focusing on Marginalized Communities
Get to Know Five of Our 2021 Social and Behavioral Research Grant Partners
December 9, 2021
By: Abigail Quinn, BA, Deeva Agravat, MSc, Kate Hopkins, PhD, MPH
The Sabin Vaccine Institute’s Vaccine Acceptance & Demand initiative is proud to provide funding to 10 grant partners awarded through the 2021 Social and Behavioral Research Grants Program. This blog is the second in a series examining the selected research projects based on one of three themes: vaccine equity, marginalized communities and social media/messaging…
 
 
Vaccine Confidence Project [to 11 Dec 2021]
http://www.vaccineconfidence.org/
News, Research and Reports
No new digest content identified.
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia [to 11 Dec 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.
 
 
Wellcome Trust [to 11 Dec 2021]
https://wellcome.ac.uk/news
News. Opinion, Reports
News
People worldwide want their governments to value science
During a global pandemic, it’s vital that governments endorse and implement scientific recommendations. We asked people around the world whether they felt their government valued scientific advice throughout the coronavirus pandemic.
8 December 2021
 
 
The Wistar Institute [to 11 Dec 2021]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.
 
 
WFPHA: World Federation of Public Health Associations [to 11 Dec 2021]
https://www.wfpha.org/
Latest News – Blog
Human Rights Day 2021
Dec 10, 2021
…The International Federation of Social Workers and World Federation of Public Health Association jointly advance a statement to continue to advocate with the United Nations, governments, companies and civil societies for the promotion of equity and respect for human rights, starting with the equitable distribution of vaccines and guaranteeing the universal right to sustainable development…
Statement link: https://drive.infomaniak.com/app/share/141741/8c4e56c4-6620-4c77-8095-e967707d8c8a/preview/pdf/39843
 
 
World Bank [to 11 Dec 2021]
http://www.worldbank.org/en/news/all
Selected News, Announcements
Ukraine to Expand COVID-19 Vaccination, with Additional World Bank Financing
WASHINGTON, December 10, 2021 – The World Bank’s Board of Executive Directors approved today $150 million in Additional Financing for the Ukraine Emergency COVID-19 Response and Vaccination Project…
Date: December 10, 2021 Type: Press Release

Learning Losses from COVID-19 Could Cost this Generation of Students Close to $17 Trillion in Lifetime Earnings
World Bank-UNESCO-UNICEF report lays out the magnitude of the education crisis WASHINGTON, DC, Dec. 6, 2021—This generation of students now risks losing $17 trillion in lifetime earnings in present…
Date: December 06, 2021 Type: Press Release

The State of the Global Education Crisis: A Path to Recovery
The global disruption to education caused by the COVD-19 pandemic is without parallel and the effects on learning are severe. The crisis brought education systems across the world to a halt, with school…
Date: December 03, 2021 Type: Publication
 
 
World Organisation for Animal Health (OIE) [to 11 Dec 2021]
https://www.oie.int/en/media/news/
Press Releases, Statements
OIE Statement on monitoring white-tailed deer for SARS-CoV-2
Statements
3 December 2021
Recent scientific research has shown a high prevalence of SARS-CoV-2 infection within white-tailed deer populations in North America. This is the first time that the virus has been detected at population levels in wildlife. This discovery requires further research to determine if white-tailed deer could become a reservoir of SARS-CoV-2 and to assess other animal or public health implications. As they do not show clinical signs of infection, white-tailed deer should be monitored for the possibility of becoming a silent reservoir.
While there is currently no evidence of transmission of SARS-CoV-2 from white tailed-deer to humans, there appears to have been multiple introductions of the virus into white-tailed deer populations by humans. We encourage countries to raise awareness with both hunters, and those living or working with wildlife, to avoid unnecessary interactions with wildlife and to avoid leaving any human waste or objects in forested areas that may be ingested or touched by deer and other wildlife…
 
 
WTO – World Trade Organisation [to 11 Dec 2021]
http://www.wto.org/english/news_e/news_e.htm
WTO News and Events
Monitoring report shows continued but slow rollback of COVID-19 related trade restrictions
9 December 2021
WTO members showed restraint in the imposition of new trade-restrictive measures related to COVID-19 and continued to roll back restrictions adopted earlier in the pandemic, according to the Director-General’s annual overview report on trade-related developments. Despite a slowdown in new trade restrictions unrelated to the pandemic, the stockpile of unrepealed restrictive measures that has accumulated since the monitoring exercise started in 2009 now affects traded merchandise worth an estimated USD 1.5 trillion, or nearly 9% of world imports.

::::::
 
 
ARM [Alliance for Regenerative Medicine] [to 11 Dec 2021]
https://alliancerm.org/press-releases/
Selected Press Releases
No new digest content identified.
 
 
BIO [to 11 Dec 2021]
https://www.bio.org/press-releases
Press Releases, Letters, Testimony, Comments [Selected]
No new digest content identified.
 
 
DCVMN – Developing Country Vaccine Manufacturers Network [to 11 Dec 2021]
http://www.dcvmn.org/
News; Upcoming events

Dr. Suresh Jadhav (1949-2021)
Pune, 07 December 2021 – Today was a sad day for all in the vaccine industry with the passing away of Dr. Suresh Jadhav: a humble, friendly yet very knowledgeable and highly respected person. His warm smile and kind words are still on our minds.
We convey our heartiest and sincere condolences to his family and close friends on his loss and pay tribute to his exemplary lifetime and dedication to vaccines and immunization.
He was a great vaccinologist and one of the persons with a pivotal role, for over 40 years, in building the Serum Institute of India global outreach, in getting WHO pre-qualification of several products.
Dr. Jadhav was also instrumental in leading the Developing Countries Vaccine Manufacturers Network (DCVMN) into its current status and we owe him a huge debt of gratitude.
We shall continue our work in respect of his life, legacy and memory.
DCVMN members
 
 
ICBA – International Council of Biotechnology Associations [to 11 Dec 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.
 
 
IFPMA [to 11 Dec 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Industry Position Paper: Optimising Post-Approval Change Management to Facilitate Continuous Supply of Medicines and Vaccines
10 December 2021
Industry Position
:: Industry acknowledges its commitment to continue improving its strategic and predictive planning and proactive communication of changes to help facilitate global supply.
:: In addition, Industry believes that global regulatory convergence of post-approval changes to Marketing Authorisations (MAs) using science and risk-based approaches will enable a more efficient management of quality and supply improvements and will facilitate patients’ access to innovative medicines and vaccines.
:: National Regulatory Authorities (NRAs) should: establish national or regional guidelines in line with
international standards (with regard to a risk based classification of changes and standardization of
requirements) [1, 2]; have clear procedural guidance including timelines; and implement reliance
pathways to accelerate the approval of changes
[1] – WHO Annex 3—Guidelines on procedures and data requirements for changes to approved
biotherapeutic products WHO Technical Report Series N° 1011, 2018
[2] – WHO Annex 4: Guidelines on procedures and data requirements for changes to approved vaccines WHO Technical Report Series N° 993, 2015

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
No new digest content identified.
 
 
International Alliance of Patients’ Organizations – IAPO [to 11 Dec 2021]
https://www.iapo.org.uk/news/topic/6
Press and media [Selected]
No new digest content identified.
 
 
PhRMA [to 11 Dec 2021]
http://www.phrma.org/
Latest News [Selected]
No new digest content identified.

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

American Journal of Public Health
December 2021 111(12)
http://ajph.aphapublications.org/toc/ajph/current

EDITORIALS
Reaffirming the Foundations of Public Health in a Time of Pandemic
Writing/Reviewing/Publishing, Other Statistics/Evaluation/Research, Statistics/Evaluation/Research, Epidemiology
Sandro Galea and Roger Vaughan

American Journal of Public Health
December 2021 111(12)
http://ajph.aphapublications.org/toc/ajph/current

PERSPECTIVES
Political Races, Religious Congregations, and Inefficacious Measures Amid the Second Wave of COVID-19 in India
Government, Health Service Delivery, Public Health Practice, Global Health
Akshay P. Raut and Nguyen Tien Huy

American Journal of Public Health
December 2021 111(12)
http://ajph.aphapublications.org/toc/ajph/current

NOTES FROM THE FIELD
Using Statewide Electronic Health Record and Influenza Vaccination Data to Plan and Prioritize COVID-19 Vaccine Outreach and Communications in Wisconsin Communities
Mortality, Prevention, Immunization/Vaccines, Statistics/Evaluation/Research, Health Promotion, Community Health
Jessica Bonham-Werling, Allie J. DeLonay, Kristina Stephenson, Korina A. Hendricks, Lauren Bednarz, Jennifer M. Weiss, Matthew Gigot and Maureen A. Smith

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 11 Dec 2021)

A re-assessment of 4CMenB vaccine effectiveness against serogroup B invasive meningococcal disease in England based on an incidence model
The four-component serogroup B meningococcal 4CMenB vaccine (Bexsero, GSK) has been routinely given to all infants in the United Kingdom at 2, 4 and 12 months of age since September 2015. After 3 years, Public He…
Authors: Lorenzo Argante, Victoria Abbing-Karahagopian, Kumaran Vadivelu, Rino Rappuoli and Duccio Medini
Citation: BMC Infectious Diseases 2021 21:1244
Content type: Research article
Published on: 11 December 2021

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 11 Dec 2021)

Number of doses of Measles-Mumps-Rubella vaccine applied in Brazil before and during the COVID-19 pandemic
Due to the social isolation measures adopted in an attempt to mitigate the risk of transmission of SARS-CoV-2, there has been a reduction in vaccination coverage of children and adolescents in several countrie…
Authors: Tércia Moreira Ribeiro da Silva, Ana Carolina Micheletti Gomide Nogueira de Sá, Ed Wilson Rodrigues Vieira, Elton Junio Sady Prates, Mark Anthony Beinner and Fernanda Penido Matozinhos
Citation: BMC Infectious Diseases 2021 21:1237
Content type: Research
Published on: 9 December 2021

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 11 Dec 2021)

COVID-19 vaccine hesitancy in people with migratory backgrounds: a cross-sectional study among Turkish- and German-speaking citizens in Munich
This study aimed to investigate the knowledge, attitudes, behaviors, and COVID-19 vaccine hesitancy of people with migratory backgrounds among Turkish- and German-speaking patients in Munich.
Authors: Zekeriya Aktürk, Klaus Linde, Alexander Hapfelmeier, Raphael Kunisch and Antonius Schneider
Citation: BMC Infectious Diseases 2021 21:1214
Content type: Research
Published on: 6 December 2021

Cell
Dec 09, 2021 Volume 184 Issue 25 p6007-6212
https://www.cell.com/cell/current

Featured Article
Infodemics: A new challenge for public health
Sylvie C. Briand, et al.
The COVID-19 information epidemic, or “infodemic,” demonstrates how unlimited access to information may confuse and influence behaviors during a health emergency. However, the study of infodemics is relatively new, and little is known about their relationship with epidemics management. Here, we discuss unresolved issues and propose research directions to enhance preparedness for future health crises.

Contemporary Clinical Trials
Volume 111 December 2021
https://www.sciencedirect.com/journal/contemporary-clinical-trials/vol/111/suppl/C

Research article Full text access
Assessing the impact of the COVID-19 pandemic on pragmatic clinical trial participants
Brian C. Coleman, Natalie Purcell, Mary Geda, Stephen L. Luther, … Robert R. Edwards
Article 106619

Contemporary Clinical Trials
Volume 111 December 2021
https://www.sciencedirect.com/journal/contemporary-clinical-trials/vol/111/suppl/C

Research article Full text access
Public attitudes to the use of remote data collection in clinical research
S. Neumann, A. Bamford, F.E. Lithander, E. Tenison, E.J. Henderson
Article 106595

EMBO Reports
Volume 22 Issue 12 6 December 2021
https://www.embopress.org/toc/14693178/current

Science & Society 4 November 2021 Open Access
Toward best practices in research: Role of academic core facilities
Leonardo Restivo et al.
Academic Core Facilities are optimally situated to improve the quality of preclinical research by implementing quality control measures and offering these to their users.

Emerging Infectious Diseases
Volume 27, Number 12—December 2021
http://wwwnc.cdc.gov/eid/

Expedited Articles
Comparative Effectiveness of Coronavirus Vaccine in Preventing Breakthrough Infections among Vaccinated Persons Infected with Delta and Alpha Variants
I. Kislaya et al.

Emerging Infectious Diseases
Volume 27, Number 12—December 2021
http://wwwnc.cdc.gov/eid/

Synopses
Evaluation of Early Warning, Alert and Response System for Ebola Virus Disease, Democratic Republic of the Congo, 2018–2020 [PDF – 1.99 MB – 11 pages]
M. Keita et al.

Epidemics
Volume 37 December 2021
https://www.sciencedirect.com/journal/epidemics/vol/37/suppl/C

Research article Open access
Quantification of the spread of SARS-CoV-2 variant B.1.1.7 in Switzerland
Chaoran Chen, Sarah Ann Nadeau, Ivan Topolsky, Marc Manceau, … Tanja Stadler
Article 100480

Epidemics
Volume 37 December 2021
https://www.sciencedirect.com/journal/epidemics/vol/37/suppl/C

Research article Open access
Assessing the risk of cascading COVID-19 outbreaks from prison-to-prison transfers
Todd L. Parsons, Lee Worden
Article 100532

Epidemics
Volume 37 December 2021
https://www.sciencedirect.com/journal/epidemics/vol/37/suppl/C

Research article Open access
Challenges of evaluating and modelling vaccination in emerging infectious diseases
Zachary J. Madewell, Natalie E. Dean, Jesse A. Berlin, Paul M. Coplan, … M. Elizabeth Halloran
Article 100506

Epidemics
Volume 37 December 2021
https://www.sciencedirect.com/journal/epidemics/vol/37/suppl/C

Research article Open access
Sustaining effective COVID-19 control in Malaysia through large-scale vaccination
Pavithra Jayasundara, Kalaiarasu M. Peariasamy, Kian Boon Law, Ku Nurhasni Ku Abd Rahim, … James M. Trauer
Article 100517

Epidemics
Volume 37 December 2021
https://www.sciencedirect.com/journal/epidemics/vol/37/suppl/C

Research article Open access
Challenges in modelling the dynamics of infectious diseases at the wildlife–human interface
Mick Roberts, Andrew Dobson, Olivier Restif, Konstans Wells
Article 100523

Global Legal Monitor – Library of Congress/USA
https://www.loc.gov/collections/global-legal-monitor/
[Accessed 11 Dec 2021]

Article
Jordan: Criminal Court Sentences Doctors and Medical Technician to Jail for Causing Death of 10 COVID Patients
On December 5, 2021, the first instance criminal court in Jordan’s capital, Amman, sentenced five health officials to three years in prison for causing the deaths of 10 COVID-19 patients in a hospital on March 13, 2021, following an oxygen outage. The patients, who were being treated at the New Salt Public Hospital, a large … Continue reading “Jordan: Criminal Court Sentences Doctors and…
Contributor: Sadek, George
Date: 2021-12-08

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 11 Dec 2021]

Measuring health science research and development in Africa: mapping the available data
In recent years there have been calls to strengthen health sciences research capacity in African countries. This capacity can contribute to improvements in health, social welfare and poverty reduction through …
Authors: Clare Wenham, Olivier Wouters, Catherine Jones, Pamela A. Juma, Rhona M. Mijumbi-Deve, Joëlle L. Sobngwi-Tambekou and Justin Parkhurst
Citation: Health Research Policy and Systems 2021 19:142
Content type: Research
Published on: 11 December 2021

Humanitarian Exchange Magazine
Number 79, May 2021
https://odihpn.org/magazine/localisation-and-local-humanitarian-action/

Localisation and local humanitarian action
by HPN October 2020
The theme of this edition of Humanitarian Exchange is localisation+ and local humanitarian action. Five years ago this week, donors, United Nations (UN) agencies,  non-governmental organisations (NGOs), the International Committee of the Red Cross (ICRC) and International Federation of Red Cross and Red Crescent Societies (IFRC) committed within the Grand Bargain to increase multi-year investments in the institutional capacities of local and national responders, and to provide at least 25% of humanitarian funding to them as directly as possible. Since then, there is increasing consensus at policy and normative level, underscored by the Covid-19 pandemic, that local leadership should be supported.  Localisation has gone from a fringe conversation among policy-makers and aid agencies in 2016 to a formal priority under the Grand Bargain. Wider global movements on anti-racism and decolonisation have also brought new momentum to critical reflections on where power, knowledge and capacity reside in the humanitarian system. Yet progress has been slow and major gaps remain between the rhetoric around humanitarian partnerships, funding and coordination and practices on the ground.

JAMA
December 7, 2021, Vol 326, No. 21, Pages 2105-2223
https://jamanetwork.com/journals/jama/currentissue

Research Letter
Racial and Ethnic Representation in US Clinical Trials of New Drugs and Biologics, 2015-2019
Milena Lolic, MD, MS; Richardae Araojo, PharmD, MS; Melvyn Okeke, MPH; et al.
JAMA. 2021;326(21):2201-2203. doi:10.1001/jama.2021.16680
This study reviews the participation of racial and ethnic populations at US sites in 2015-2019 to understand the extent to which US trial participation represents the diversity of the US population.

JAMA
December 7, 2021, Vol 326, No. 21, Pages 2105-2223
https://jamanetwork.com/journals/jama/currentissue

Original Investigation
Effect of High-Flow Oxygen Therapy vs Conventional Oxygen Therapy on Invasive Mechanical Ventilation and Clinical Recovery in Patients With Severe COVID-19A Randomized Clinical Trial
Gustavo A. Ospina-Tascón, MD, PhD; Luis Eduardo Calderón-Tapia, MD; Alberto F. García, MD, MSc; et al.
JAMA. 2021;326(21):2161-2171. doi:10.1001/jama.2021.20714
This randomized trial assesses the effect of high-flow oxygen therapy through a nasal cannula vs conventional oxygen therapy on 28-day intubation rates and time to clinical recovery among patients with respiratory distress due to COVID-19.

JAMA
December 7, 2021, Vol 326, No. 21, Pages 2105-2223
https://jamanetwork.com/journals/jama/currentissue

Antibody Titers Before and After a Third Dose of the SARS-CoV-2 BNT162b2 Vaccine in Adults Aged ≥60 Years
Noa Eliakim-Raz, MD; Yaara Leibovici-Weisman, MD; Amos Stemmer, MD; et al.
free access has active quiz
JAMA. 2021;326(21):2203-2204. doi:10.1001/jama.2021.19885
This study assesses antispike (anti-S) IgG antibody titers before and after a third BNT162b2 dose (booster) in individuals aged 60 years and older in Israel.

JAMA
December 7, 2021, Vol 326, No. 21, Pages 2105-2223
https://jamanetwork.com/journals/jama/currentissue

Viewpoint
Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements
Reshma Ramachandran, MD, MPP; Christopher J. Morten, JD, PhD; Joseph S. Ross, MD, MHS
free access
JAMA. 2021;326(21):2131-2132. doi:10.1001/jama.2021.19773
This Viewpoint discusses ways in which the FDA could harness its enforcement tools to bring important missing clinical trial results information to light and demonstrate its commitment to protecting patients through clinical trial transparency.