Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 19 Sep 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 19 Sep 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

 

BMGF – Gates Foundation [to 19 Sep 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
SEPTEMBER 14, 2020
Gates Foundation’s Annual Goalkeepers Report Shows COVID-19 Has Stalled 20 Years of Progress, Calls for Global Response to End the Pandemic
Report shows how economic damage has reinforced inequities and derailed achievement of the UN Sustainable Development Goals; spotlights countries innovating to meet challenges

 

Bill & Melinda Gates Medical Research Institute [to 19 Sep 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 19 Sep 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 19 Sep 2020]
http://cepi.net/
COVAX: A Moment of Truth in the Pandemic
18 Sep 2020
{See Week in Review above for detail]

 

EDCTP [to 19 Sep 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 19 Sep 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 19 Sep 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020
CHMP, Last updated: 18/09/2020
… The Committee recommended granting marketing authorisations for two vaccines: MenQuadfi (meningococcal group A, C, W and Y conjugate vaccine), for prophylaxis against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y; and Supemtek (Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture)), for prophylaxis against influenza…

 

 

News: EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation
CHMP, Last updated: 18/09/2020

 

European Vaccine Initiative [to 19 Sep 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 19 Sep 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
September 18, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 18, 2020
Testing updates:
As of today, 248 tests are authorized by FDA under EUAs; these include 198 molecular tests, 46 antibody tests, and 4 antigen tests.

September 17, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 17, 2020

September 16, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 16, 2020
On September 15, 2020, the FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection, indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting, as well as the sedation of non-intubated patients prior to and/or during surgical and other procedures.

September 15, 2020 – Coronavirus (COVID-19) Update: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests
Today, the U.S. Food and Drug Administration published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA. The FDA provided these standardized samples, known as a reference panel, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their Emergency Use Authorization (EUA)…

September 15, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 15, 2020

September 14, 2020 – Coronavirus (COVID-19) Update: Daily Roundup September 14, 2020

 

Fondation Merieux [to 19 Sep 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

 

Gavi [to 19 Sep 2020]
https://www.gavi.org/
News releases
16 September 2020
A record-breaking year for childhood immunisation
Looking back over last year, Gavi’s 2019 Annual Progress Report is the fourth in a series of five covering this strategic period. Highlighting key data points, milestones and partnerships, the report offers insights into our progress during what was, in many ways, a banner year for the Vaccine Alliance.

 

GHIT Fund [to 19 Sep 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.

 

Global Fund [to 19 Sep 2020]
https://www.theglobalfund.org/en/news/
News/Updates
News
Global Fund Partnership Has Saved 38 Million Lives – but COVID-19 Could Wipe Out Progress
14 September 2020
A new report by the Global Fund to Fight AIDS, Tuberculosis and Malaria is a call to action to urgently invest to protect decades of progress against HIV, TB and malaria that are being derailed as a knock-on effect of the COVID-19 pandemic.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 19 Sep 2020]
https://www.glopid-r.org/news/
News
The Global Preparedness Monitoring Board releases report: “A World In Disorder”
16/09/2020
[See Milestones above for detail]

 

Hilleman Laboratories [to 19 Sep 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 19 Sep 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Release
No new digest content identified.

 

IAVI [to 19 Sep 2020]
https://www.iavi.org/newsroom
FEATURES
September 15, 2020
Updated: The Effects of COVID-19 on IAVI Clinical Programs

 

 

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 19 Sep 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Asia Pacific, Indonesia, Malaysia, Myanmar, Pakistan
Asia Survey: 1 in 2 blame foreigners and rule-breakers for COVID-19
Kuala Lumpur/Geneva, 17 September 2020 – A major new survey in four Asian countries reveals nearly one in two people blame specific groups for spreading COVID-19.  The survey shows that people are blaming particular groups for spreading the coronavirus …
17 September 2020

 

IRC International Rescue Committee [to 19 Sep 2020]
http://www.rescue.org/press-release-index
Media highlights {Selected]
[No new digest content identified]

 

IVAC [to 19 Sep 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
Webinar Recording: Avoiding Barriers to Access for a COVID-19 Vaccine
The International Vaccine Access Center (IVAC) hosted a webinar on September 16th,
Description: Even before the COVID-19 pandemic, countries worked to overcome a myriad of challenges when introducing new safe and effective vaccines. While policy makers and health advocates addressed barriers, from understanding disease burden and cost effectiveness to establishing cold chain systems, preventable diseases spread, sicken populations, and cost lives. Learning from the past failures of vaccine introductions will be crucial for ensuring equitable access to a COVID-19 vaccine. Leaders and scientists in the international vaccine field discussed the barriers to vaccine access we must overcome to avoid and the role the international community will play in promoting equity in delivering a COVID-19 vaccine.
The webinar featured a presentation by Jerome Kim, MD, Director General, IVI.
Video: https://youtu.be/5U6SYVqhquY
Slides: https://www.jhsph.edu/ivac/wp-content/uploads/2020/09/Presentation_Barriers-to-Vaccine-Access.pdf

 

IVI [to 19 Sep 2020]
http://www.ivi.int/
Selected IVI News & Announcements
Typhoid: Study confirms Vi-DT conjugate vaccine is safe and immunogenic in children 6-23 months of age
September 17, 2020 – SEOUL, South Korea – A new study conducted by IVI in collaboration with SK bioscience shows that single-dose and two-dose regimens of Vi-DT typhoid conjugate vaccine (TCV) are safe and immunogenic in children 6-23 months of age, a group with high rates of typhoid fever in resource-limited settings. The findings from this study newly published online in The Lancet’s EClinicalMedicine describe the successful completion and analysis of a Phase II clinical trial of Vi-DT six months after vaccination…

 

JEE Alliance [to 19 Sep 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 19 Sep 2020]
http://www.msf.org/
Latest [Selected Announcements]
Mediterranean migration
“Enough is enough”: Time to stop the cycle of suffering for refugees on Greek islands
Project Update 17 Sep 2020

Coronavirus COVID-19 pandemic
MSF works to prevent spread of COVID-19 among indigenous people in Mato Grosso do Sul
Project Update 17 Sep 2020

Central African Republic
In times of COVID-19, malaria remains the number one killer of children in CAR
Project Update 15 Sep 2020

 

National Vaccine Program Office – U.S. HHS [to 19 Sep 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC Meetings
September 23-24, 2020 Meeting (Virtual)
Selected Agenda Topics:
:: Serving Up Equity: Health-In-All Approaches for COVID-19 Vaccination [Panel]
:: Allocation and Prioritization: Considerations and Recommendations for the Distribution of
COVID-19 Vaccines [Dr. Ezekiel Emanuel, University of Pennsylvania; CDC tbd]
:: Perspectives from the Field: Operation Warp Speed [Dr. Moncef Slaoui, HHS]
:: The Infodemic, COVID-19 Immunization, and the Public’s Health [Panel]
:: Immunization Information Systems to Support the COVID-19 Response [Panel]

 

NIH [to 19 Sep 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH funds community engagement research efforts in areas hardest hit by COVID-19
September 16, 2020 — Outreach will focus on COVID-19 awareness and education research, especially among African Americans, Hispanics/Latinos, and American Indians.
The National Institutes of Health today announced a $12 million award for outreach and engagement efforts in ethnic and racial minority communities disproportionately affected by the COVID-19 pandemic. The award to RTI International, a non-profit research institution, will support teams in 11 states established as part of the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities. These teams have received initial funding to immediately create CEAL programs, and RTI will serve as the Technical and Administrative Support and Coordination (TASC) center.
The CEAL research teams will focus on COVID-19 awareness and education research, especially among African Americans, Hispanics/Latinos, and American Indians — populations that account for over half of all reported cases in the United States. They also will promote and facilitate the inclusion and participation of these groups in vaccine and therapeutic clinical trials to prevent and treat the disease.
The communities of special focus include counties in Alabama, Arizona, California, Florida, Georgia, Louisiana, Michigan, Mississippi, North Carolina, Tennessee and Texas…

NIH awards contracts to develop innovative digital health technologies for COVID-19
September 15, 2020 — The projects represent a broad range of solutions for immediate public health needs related to the pandemic.
The National Institutes of Health has awarded seven contracts to companies and academic institutions to develop digital health solutions that help address the COVID-19 pandemic. The work could lead to user-friendly tools such as smartphone apps, wearable devices, and software that can identify and trace contacts of infected individuals, keep track of verified COVID-19 test results, and monitor the health status of infected and potentially infected individuals.
The National Cancer Institute (NCI) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB), both part of NIH, selected the seven projects from nearly 200 different ideas. The projects represent a broad range of solutions for immediate public health needs related to the pandemic, and several focus on solutions for medically underserved communities and people with limited access to health care, who are disproportionally affected by COVID-19…

Substance use disorders linked to COVID-19 susceptibility
September 14, 2020 — NIH research finds higher risk and worse outcomes for those with addiction.

 

PATH [to 19 Sep 2020]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

 

Sabin Vaccine Institute [to 19 Sep 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 19 Sep 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
18 September 2020
COVID-19 brings Jamaican people living with HIV closer together

16 September 2020
Pacific Unite concert promotes solidarity during the COVID-19 pandemic

15 September 2020
Somalia: building a stronger primary health care system

15 September 2020
Shelter for key populations in Kyrgyzstan

 

 

R

 

Unitaid [to 19 Sep 2020]
https://unitaid.org/
Featured News
No new digest content identified.

 

Vaccination Acceptance Research Network (VARN) [to 19 Sep 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 19 Sep 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 19 Sep 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 19 Sep 2020]
https://wellcome.ac.uk/news
Opinion | 16 September 2020
Could Covid-19 be fuelling drug resistance?
Gemma Buckland Merrett
Science Lead, Drug-Resistant Infections Wellcome
We need to understand the impact of Covid-19 on wider health issues to shape better public health responses and limit long-term consequences. Drug resistance is one of these, Gemma Buckland-Merrett explains.

 

The Wistar Institute [to 19 Sep 2020]
https://www.wistar.org/news/press-releases
Press Releases
Press Release
Sep. 14, 2020
Wistar Appoints Ami Patel, Ph.D., as Caspar Wistar Fellow
Caspar Wistar Fellowship launches the careers of up-and-coming biomedical researchers as top scientific leaders.

 

WFPHA: World Federation of Public Health Associations [to 19 Sep 2020]
https://www.wfpha.org/
Latest News
Statement on COVID-19 Immunization and Equitable Access to Vaccines
Friday, 18 September 2020
[See COVID above for full text]

 

World Organisation for Animal Health (OIE) [to 19 Sep 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 19 Sep 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.

 

BIO [to 19 Sep 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 19 Sep 2020]
http://www.dcvmn.org/
News; Upcoming events
14 September 2020
DCVMN Congratulates WHO African Region for Wild Polio-Free Certification
Brazzaville 25th August 2020 – The Africa Regional Certification Commission certified the WHO African Region as wild polio-free after four years without a case. With this historic milestone, five of the six WHO regions – representing over 90% of the world’s population – are now free of the wild poliovirus, moving the world closer to achieving global polio eradication…
… DCVMN company members are proud of contributing towards eradication with supply of polio vaccines to the African continent.
Despite a challenging year for global health, the certification of the African region as wild poliovirus-free is a sign of hope and progress. The resources and expertise used to eliminate wild polio have significantly contributed to Africa’s public health and outbreak response systems. The polio programme provides health benefits to local communities, from supporting the African region’s response to COVID-19 to bolstering routine immunization against other vaccine-preventable diseases.

 

ICBA – International Council of Biotechnology Associations [to 19 Sep 2020]
https://internationalbiotech.org/
News
No new digest content identified.

 

IFPMA [to 19 Sep 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA Statement on the G-FINDER Report “Landscape of Emerging Infectious Disease R&D: Preventing the Next
17 September 2020
The latest G-Finder report “Landscape of Emerging Infectious Disease R&D: Preventing the next pandemic” shows that to be better prepared in the future, the R&D funding needs to be more diversified and supported by a wider range of funders. It also highlights the central role that product development partnerships (PDPs) and initiatives such as the Coalition for Epidemic Preparedness Innovations (CEPI), play to provide a coordination mechanism which pools funding from different organizations to advance research.

IFPMA Statement to G20 Health and Finance Ministers
17 September 2020
[See G20 above for detail]

Safety of vaccinated individuals is the top priority in development of COVID-19 vaccines
15 September 2020
IFPMA is strongly committed to rigorous regulatory standards for approval of COVID-19 treatments and vaccines. No matter how urgently action is needed against the coronavirus public health emergency, it is imperative that the highest standards of quality, safety and efficacy are upheld everywhere. IFPMA member companies are fully committed to transparency in reporting clinical trial results whether these are good or bad; they support the need to inform the public of what they know, as well as what they don’t know about the vaccines in development.

The innovative vaccine industry voiced its strong commitment to rigorous regulatory standards for approval of COVID-19 vaccines in a statement. As part of this commitment, leading vaccine manufacturers issued a pledge to make the safety and well-being of vaccinated individuals a the top priority in development of the first COVID-19 vaccines.

Coinciding with the launch of the pledge, Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) wrote in an Opinion in The Financial Times: “We must prioritise thorough validation of the results of pre-clinical and clinical trials by independent expert bodies. Only the most rigorous application of science and openness in the regulatory process can ensure that everyone, starting with healthcare workers, has confidence in Covid-19 vaccines once they have been properly approved”.

 

PhRMA [to 19 Sep 2020]
http://www.phrma.org/
Selected Press Releases, Statements
Coming together to fight COVID-19: A conversation with Albert Bourla, Chairman & CEO of Pfizer, Inc.
Stephen J. Ubl   |     September 17, 2020
Over the last seven months, our industry has been working around the clock to combat the COVID-19 virus, including developing potential therapeutics to treat COVID-19 and vaccines to prevent future infections.
Last week, I had the opportunity to connect with Albert Bourla, Chairman & CEO of Pfizer Inc., about the fight against COVID-19

Guest Post: How proactivity and planning helped Novartis ensure a stable supply of medicines during COVID-19
Guest Contributor   |     September 16, 2020
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view. Today, we are pleased to welcome a guest post from Steffen Lang, Ph.D., Global Head of Novartis Technical Operations to discuss how Novartis has plans in place to help ensure their supply chains remain operational even in unexpected situations like COVID-19.