Announcements

Announcements

 

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

 

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

 

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

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

 

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

 

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

 

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

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

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

 

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

 

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

 

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

 

 

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

 

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

 

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

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

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

 

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

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

 

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

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

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

 

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

 

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

 

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

 

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

 

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

 

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

 

 

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

 

 

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

 

 

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

 

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

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

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

 

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

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

 

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

 

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

 

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

 

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

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

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

 

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

 

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

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

 

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

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

 

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

 

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

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

28 September 2020
New HIV infections increasingly among key populations

 

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

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

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

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

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

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

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

 

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

 

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

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

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

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

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

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

 

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

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

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

 

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

 

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

 

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

 

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