Paul G. Allen Frontiers Group [to 28 Nov 2020]
No new digest content identified.


BARDA – U.S. Department of HHS [to 28 Nov 2020]
No new digest content identified.


BMGF – Gates Foundation [to 28 Nov 2020]
Press Releases and Statements
No new digest content identified.


Bill & Melinda Gates Medical Research Institute [to 28 Nov 2020]
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.


CARB-X [to 28 Nov 2020]
No new digest content identified.


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

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

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

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


EDCTP [to 28 Nov 2020]
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
24 November 2020
Largest clinical trial in Africa to treat mild to moderate COVID-19 patients launched in 13 countries
Thirteen African countries and an international network of research institutions have joined forces to launch the largest clinical trial in mild-to-moderate COVID-19 outpatients in Africa. The ANTICOV clinical trial aims to identify treatments for these cases and thus to contribute to the prevention of spikes in hospitalisation that could overwhelm health systems in Africa.*

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

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

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

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

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


Emory Vaccine Center [to 28 Nov 2020]
Vaccine Center News
No new digest content identified.


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

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

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

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


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


FDA [to 28 Nov 2020]
Press Announcements /Selected Details
November 25, 2020 – Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators

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

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

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

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


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


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


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

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


GHIT Fund [to 28 Nov 2020]
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.


Global Fund [to 28 Nov 2020]
44th Board Meeting Documents

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

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


Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 28 Nov 2020]
No new digest content identified.


Hilleman Laboratories [to 28 Nov 2020]
No new digest content identified.


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


IAVI [to 28 Nov 2020]
No new digest content identified.



International Coalition of Medicines Regulatory Authorities [ICMRA]
Selected Statements, Press Releases, Research
Statement on continuation of vaccine trials
Undated – presume week of 23 Nov 2020
[See COVID-19 Vaccine Development above for detail]



International Generic and Biosimilar Medicines Association [IGBA]
No new digest content identified.



Press Releases/Announcements
No new digest content identified.


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

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


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


IRC International Rescue Committee [to 28 Nov 2020]
Media highlights [Selected]
As tensions rise in Mekelle, Ethiopia, IRC warns of impending humanitarian disaster
November 27, 2020

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

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


IVAC [to 28 Nov 2020]
Updates; Events
No new digest content identified.


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

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

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


JEE Alliance [to 28 Nov 2020]
Selected News and Events
No new digest content identified.


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

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

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


National Vaccine Program Office – U.S. HHS [to 28 Nov 2020]
Upcoming Meetings
December 4, 2020 NVAC Meeting (Virtual)
[See COVID Vaccines Regulatory Meetings/Milestones above]


NIH [to 28 Nov 2020]
News Releases
Fourth iteration of COVID-19 treatment trial underway
November 25, 2020 — Study will enroll hospitalized adults with COVID-19 who require supplemental oxygen.

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


PATH [to 28 Nov 2020]
Press Release
No new digest content identified.


Sabin Vaccine Institute [to 28 Nov 2020]
Statements and Press Releases
No new digest content identified.


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

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

24 November 2020
Turning around the HIV response in Odessa

23 November 2020
Condom use declining


UNICEF [to 28 Nov 2020]
Selected Press releases, Statements
Threat of further escalation in Mekelle, Ethiopia, puts children’s lives at risk
Statement by UNICEF Executive Director Henrietta Fore

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

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

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


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


Vaccination Acceptance Research Network (VARN) [to 28 Nov 2020]
No new digest content identified.


Vaccine Confidence Project [to 28 Nov 2020]
Research and Reports
No new digest content identified.


Vaccine Education Center – Children’s Hospital of Philadelphia [to 28 Nov 2020]
No new digest content identified.


Wellcome Trust [to 28 Nov 2020]
No new digest content identified.


The Wistar Institute [to 28 Nov 2020]
Press Releases
No new digest content identified.


WFPHA: World Federation of Public Health Associations [to 28 Nov 2020]
Latest News
Producing a Safe and Effective Vaccine: Align Public Health Needs with Economic & Social Development Objectives
Nov 25, 2020
Producing a Safe and Effective Vaccine: Align Public Health Needs with Economic & Social Development Objectives Webinar recording:

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


World Organisation for Animal Health (OIE) [to 28 Nov 2020]
No new digest content identified.





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


BIO [to 28 Nov 2020]
Press Releases
No new digest content identified.


DCVMN – Developing Country Vaccine Manufacturers Network [to 28 Nov 2020]
News; Upcoming events
No new digest content identified.


ICBA – International Council of Biotechnology Associations [to 28 Nov 2020]
No new digest content identified.


IFPMA [to 28 Nov 2020]
Selected Press Releases, Statements, Publications
No new digest content identified.


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

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

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