Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 25 July 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 25 July 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
July 22, 2020: U.S. Government Engages Pfizer to Produce Millions of Doses of COVID-19 Vaccine
The U.S. Department of Health and Human Services and the Department of Defense (DoD) today announced an agreement with U.S.-based Pfizer Inc. for large-scale production and nationwide delivery of 100 million doses of a COVID-19 vaccine in the United States following the vaccine’s successful manufacture and approval. The agreement also allows the U.S. government to acquire an additional 500 million doses.
The federal government will own the 100 million doses of vaccine initially produced as a result of this agreement, and Pfizer will deliver the doses in the United States if the product receives Emergency Use Authorization (EUA) or licensure from the U.S. Food and Drug Administration (FDA), as outlined in FDA guidance, after completing demonstration of safety and efficacy in a large Phase 3 clinical trial.
By entering into this agreement now, a safe and effective vaccine can be shipped quickly if FDA grants EUA or licensure. This approach helps meet the U.S. government’s Operation Warp Speed goal to begin delivering 300 million of doses of safe and effective vaccine to the American people by
the end of the year…

 

BMGF – Gates Foundation [to 25 July 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 25 July 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 25 July 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 25 July 2020]
http://cepi.net/
Latest News
CEPI extends funding call to accelerate development and global manufacture of COVID-19 vaccines
21 Jul 2020 By Jodie Rogers
CEPI has extended its Call for Proposals to advance development and manufacture of COVID-19 vaccine candidates
Vaccine developers with end-to-end experience and capability for the global supply of COVID-19 vaccine doses in 12-18 months are encouraged to apply
The new call will look more favourably on vaccine candidates that, based on field experience to date, have indications that their candidate vaccine is able to offer measurable protection after one dose.

 

EDCTP [to 25 July 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 25 July 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 25 July 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
News 24/07/2020
Eleven new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eleven medicines for approval at its July 2020 meeting, including a medicine for use in countries outside the European Union.
The CHMP adopted a positive opinion for Dapivirine Vaginal Ring (dapivirine) used to reduce the risk of infection with the human immunodeficiency virus type 1 (HIV-1), in combination with safer sex practices when oral pre-exposure prophylaxis is not used, cannot be used or is not available. Placed in the vagina, the ring slowly releases the antiretroviral medicine dapivirine over a period of 28 days.
This is the eleventh medicine recommended by EMA under EU Medicines for all (EU-M4All), a mechanism that allows the CHMP to assess and give opinions on medicines that are intended for use in countries outside the EU under Article 58 of Regulation (EC) No 726/2004…

 

 

News: EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support
CHMP, Last updated: 24/07/2020

 

 

News: COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines
Last updated: 21/07/2020
EMA has now set up an infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice. This is underpinned by three contracts for observational research that EMA has signed with academic and private partners over recent months, to be ready to effectively monitor vaccines in the real world as soon as they are authorised, and support the safe and effective use of COVID-19 vaccines and medicines.
The latest contract was finalised in mid-July with Utrecht University and the University Medical Center Utrecht as coordinators of the CONSIGN project (‘COVID-19 infectiOn aNd medicineS In preGNancy’). This project will collect data on the impact of COVID-19 in pregnancy in order to guide decision-making about vaccine indications, vaccination policies and treatment options for COVID-19 in pregnant women. CONSIGN will analyse existing data sources (e.g. electronic health records, hospital data) and cohorts of pregnant women to provide information on the effect of infection and its treatments in different trimesters of pregnancy and on neonates. The project will be carried out in collaboration with the ConcePTION consortium, which was established under the EU’s Innovative Medicines Initiative, the COVI-PREG project and the International Network of Obstetric Survey Systems (INOSS) network.
In June, EMA contracted the company IQVIA with a project to build a framework for the conduct of multicentre cohort studies on the use of medicines in COVID-19 patients. This project will include the identification of large national cohorts of COVID-19 patients and appropriate comparator groups, the development of a study protocol template for multinational studies as well as the establishment of a collaborative framework for researchers. The project will be carried out in collaboration with the European Health Data & Evidence Network (EHDEN) consortium, which was established under the Innovative Medicines Initiative and includes the Erasmus Medical Centre in Rotterdam and the University of Oxford as project lead and research coordinator, respectively.*
In May, EMA commissioned the ACCESS project (‘vACcine Covid-19 monitoring readinESS’) for preparatory research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice, once authorised…

 

European Vaccine Initiative [to 25 July 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 25 July 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
July 24, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection

July 24, 2020 – Coronavirus (COVID-19) Update: Daily Roundup July 24, 2020

July 23, 2020 – Coronavirus (COVID-19) Update: Daily Roundup July 23, 2020

July 22, 2020 – Coronavirus (COVID-19) Update: Daily Roundup July 22, 2020

July 21, 2020 – Coronavirus (COVID-19) Update: Daily Roundup July 21, 2020

July 20, 2020 – Coronavirus (COVID-19) Update: Daily Roundup July 20, 2020

 

Fondation Merieux [to 25 July 2020]
http://www.fondation-merieux.org/
News, Events
Project
The Mérieux Foundation, FIND, ASLM and LSHTM are launching a MOOC on COVID-19 Diagnostics and Testing
July 21, 2020 – Lyon, France
This online course, available in English and French as of July 20, is open for registration. It is designed for professionals involved in the diagnostics and testing of COVID-19, with a focus on low- and middle-income settings.

 

Gavi [to 25 July 2020]
https://www.gavi.org/
News releases
24 July 2020
Why the UK wants to recruit half a million people in a COVID-19 vaccine trial

23 July 2020
Delivering life-saving vaccines during the COVID-19 pandemic

22 July 2020
What happens if COVID-19 mutates?

 

GHIT Fund [to 25 July 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 25 July 2020]
https://www.theglobalfund.org/en/news/
No new digest content identified.

 

Hilleman Laboratories [to 25 July 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 25 July 2020]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.

 

IAVI [to 25 July 2020]
https://www.iavi.org/newsroom
Features
July 21, 2020
Surveying the HIV Vaccine and Cure Landscape at AIDS 2020 Virtual
Thumbi Ndung’u, Ph.D., provides a view of current strategies for HIV vaccine and cure design

 

 

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 25 July 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Americas
Red Cross on the ground bracing for tropical storm Gonzalo in the Caribbean
Panama/Port of Spain, 23 July 2020 — The International Federation of Red Cross and Red Crescent Societies (IFRC) is preparing a humanitarian response as the Caribbean braces for their first tropical storm of 2020. A hurricane watch is in effect for Bar …
24 July 2020

Asia Pacific, Indonesia
Red Cross urges Indonesians to change behavior to slow COVID-19
Jakarta/Kuala Lumpur, 24 July 2020 –  Indonesian Red Cross is calling on Indonesians to continue practising physical distancing and to exercise greater caution to prevent COVID-19 infections from spiralling out of control as the country adapts to a `ne …
24 July 2020

Asia Pacific, Bangladesh, India, Nepal
South Asia floods: 9.6 million people swamped as humanitarian crisis deepens
Kuala Lumpur/Delhi/Dhaka/Kathmandu/Geneva, 22 July 2020 – A humanitarian crisis is deepening in South Asia as new figures reveal that more than 9.6 million people have been affected by monsoon floods, devastating large areas of India, Bangladesh and Ne …
22 July 2020

 

IVAC [to 25 July 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
Q&A: Enhancing Public Trust and Health with COVID-19 Vaccination
July 2020
IVAC experts contribute to the Center for Health Security report on Enhancing Public Trust and Health With COVID-19 Vaccination.

 

IVI [to 25 July 2020]
http://www.ivi.int/
Selected IVI News & Announcements
No new digest content identified.

 

JEE Alliance [to 25 July 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 25 July 2020]
http://www.msf.org/
Latest [Selected Announcements]
Nigeria
MSF condemns the killing of five aid workers in northeast Nigeria
Statement 23 Jul 2020

Kyrgyzstan
In remote Kyrgyzstan, COVID-19 puts a strain on the health system
Project Update 22 Jul 2020

Syria
COVID-19 provokes fears over further health system decline in northwestern Sy…
Project Update 21 Jul 2020

 

National Vaccine Program Office – U.S. HHS [to 25 July 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC Meetings
September 23-24, 2020 Meeting (Virtual)
February 4-5, 2021 NVAC Meeting
June 16-17, 2021 NVAC Meeting

 

NIH [to 25 July 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
Vaginal ring for HIV prevention receives positive opinion from European regulator
July 24, 2020 — NIAID celebrates pivotal step toward expanding HIV prevention choices for women.

NIH leadership details unprecedented initiative to ramp up testing technologies for COVID-19
July 22, 2020 — RADx efforts seek to create capacity for 6 million daily tests by the end of 2020, address underserved populations.
In a paper in the New England Journal of Medicine(link is external), scientific leaders from the National Institutes of Health set forth a framework to increase significantly the number, quality and type of daily tests for detecting SARS-CoV-2, the virus that causes COVID-19, and help reduce inequities for underserved populations that have been disproportionally affected by the disease. The authors describe the current testing landscape and explain the urgent need for nationwide deployment of low-complexity, point-of-care molecular diagnostics with rapid results. To fill this urgent need, the Rapid Acceleration of Diagnostics (RADx) program was established in just five days following the announcement of $1.5 billion in federal stimulus funding in April 2020. RADx covers the entire life cycle of the target testing technologies,..

 

PATH [to 25 July 2020]
https://www.path.org/media-center/
Selected Announcements
Milestone study identifies immune markers that may help predict success of vaccination with RTS,S/AS01 malaria vaccine
July 22, 2020 by PATH
Results of partnership between the Ragon Institute, GSK Vaccines, and PATH is key step in understanding human protection against Plasmodium falciparum infection; could help accelerate clinical trials of future malaria vaccines

 

Sabin Vaccine Institute [to 25 July 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 25 July 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
23 July 2020
Phenomenal Positive Youths lead the way during COVID-19 pandemic in Zambia

21 July 2020
UNAIDS celebrates the life of Mozambican AIDS activist Tauzene Murgo

21 July 2020
A safe space for key populations in Armenia

 

UNICEF [to 25 July 2020]
https://www.unicef.org/media/press-releases
Selected Press releases/Announcements
Press release
07/23/2020
Millions of children affected by devastating flooding in South Asia, with many more at risk as COVID-19 brings further challenges

Press release
07/23/2020
UNICEF and partners respond to the triple threat of floods, locusts and COVID-19 in Somalia
Over 3 million Somali children in need of humanitarian assistance

Press release
07/23/2020
Number of separated children rising fast as Ebola spreads in Equateur Province of DRC

Press release
07/21/2020
40 million children miss out on early education in critical pre-school year due to COVID-19

Statement
07/21/2020
Joint Call to Action: Reimagining the World We Need
by Henrietta Fore, Executive Director of UNICEF, and John W.H. Denton, AO Secretary General of the International Chamber of Commerce
[See Milestones above for detail]

 

Unitaid [to 25 July 2020]
https://unitaid.org/
Featured News
No new digest content identified.

 

Vaccination Acceptance Research Network (VARN) [to 25 July 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 25 July 2020]
http://www.vaccineconfidence.org/
Latest News & Archive
Confusion spreads over system to determine priority access to Covid-19 vaccines
23 July 2020
[See Milestones above for detail]

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 25 July 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 25 July 2020]
https://wellcome.ac.uk/news
Opinion | 24 July 2020
Our response to COVID-19 will help define the 21st century
Jeremy Farrar, Director Wellcome
The true impact of the COVID-19 pandemic will be felt beyond its immediate effects. Jeremy Farrar explains why the choices leaders make now will help define the 21st century.
[See Milestones above for detail]

 

The Wistar Institute [to 25 July 2020]
https://www.wistar.org/news/press-releases
Press Released
No new digest content identified.

 

WFPHA: World Federation of Public Health Associations [to 25 July 2020]
https://www.wfpha.org/
Latest News
WFPHA Statement on COVID-19 Immunization
Friday, 24 July 2020
Immunization is one of the most successful public health measures of modern times. Annually immunization prevents an estimated 2.5 million deaths globally and reduces disease-specific treatment costs (WHO 2018). For all the devastation caused by COVID-19, an important lesson is that the balance needs to shift from treating disease to preventing it. Specific to COVID-19, almost everyone is at risk and may require vaccination if given the opportunity. Hence, it is likely that demand will surpass supply. The concern of the WFPHA Immunisation Taskforce is the tendency for the rich to acquire and pay for the limited supply of available efficacious vaccines to the detriment of the at-risk populations in low income settings. Therefore, the WFPHA Immunisation Taskforce provides some recommendations. Read the recommendations and statement here.
[See Milestones above for detail]

 

World Organisation for Animal Health (OIE) [to 25 July 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
Global action needed now to halt spread of deadly pig disease
The escalation of the spread of African swine fever (ASF) has placed most of the world’s domestic and wild pig populations under direct threat. To support countries’ efforts to protect economies and food security, the World Organisation for Animal Health (OIE) and the Food and Agriculture Organization of the United Nations (FAO) today launch a joint initiative for the Global Control of ASF.
Paris | Rome, 20 July 2020 – Pork is the most consumed meat in the world, representing 35.6 percent of global meat consumption. In recent years, ASF – which may cause up to 100 percent mortality in pigs – has become a major crisis for the pork industry, causing massive losses in pig populations and generating drastic economic consequences. Currently affecting several countries of Africa, Asia and the Pacific, and Europe, and with no effective vaccine, the disease is not only impeding animal health and welfare but has detrimental impacts on the livelihoods of farmers.

“Today, 51 countries are affected by African swine fever. Amid the difficult situation posed by COVID-19, ASF continues to spread, intensifying the current health and socioeconomic crises,” said Dr Matthew Stone, OIE Deputy Director General for International Standards and Science.
Many countries that are affected by ASF lack sufficient human, financial or technical resources to rapidly detect, respond and contain animal diseases.

“In this globalised world, where diseases can spread rapidly across borders, timely sharing of latest scientific information, international collaboration and notification of ASF are needed to prevent transboundary spread and minimise impact,” said FAO Deputy Director-General, Maria Helena Semedo…

 

 

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ARM [Alliance for Regenerative Medicine] [to 25 July 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.

 

BIO [to 25 July 2020]
https://www.bio.org/press-releases
Press Releases
BIO’s Dr. McMurry-Heath Warns Executive Order to “Cripple Small, Innovative Companies” Working to Eradicate COVID-19
July 24, 2020
[See PhRMA below]

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 25 July 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

IFPMA [to 25 July 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 25 July 2020]
https://internationalbiotech.org/
News
No new digest content identified.

 

PhRMA [to 25 July 2020]
http://www.phrma.org/
Selected Press Releases, Statements
PhRMA Statement on Drug Pricing Executive Orders
July 24, 2020
WASHINGTON, D.C. (July 24, 2020) – Pharmaceutical Research and Manufacturers of America President and CEO Stephen J. Ubl made the following statement:
“In his 2020 State of the Union Address, President Trump declared that ‘we will never let socialism destroy American health care.’
“Yet, in the middle of a global pandemic, when nearly 145,000 Americans have lost their lives and millions of others have suffered untold economic hardships, this administration has decided to pursue a radical and dangerous policy to set prices based on rates paid in countries that he has labeled as socialist, which will harm patients today and into the future.
“The research-based biopharmaceutical industry has been working around the clock to develop therapeutics and vaccines to treat and prevent COVID-19. The administration’s proposal today is a reckless distraction that impedes our ability to respond to the current pandemic – and those we could face in the future. It jeopardizes American leadership that rewards risk-taking and innovation and threatens the hope of patients who need better treatments and cures.
“The president’s attempt to open our country up to socialized health care sets America, our economic recovery and scientific progress back at a time when we need them most.”

Executive Order on Increasing Drug Importation to Lower Prices for American Patients
Issued on: July 24, 2020
Section 1.  Purpose.  Americans spend more per capita on pharmaceutical drugs than residents of any other developed country.  Americans often pay more for the exact same drugs, even when they are produced and shipped from the exact same facilities.

One way to minimize international disparities in price is to increase the trade of prescription drugs between nations with lower prices and those with persistently higher ones.  Over time, reducing trade barriers and increasing the exchange of drugs will likely result in lower prices for the country that is paying more for drugs.

Sec. 2.  Permitting the Importation of Safe Prescription Drugs from Other Countries.  The Secretary of Health and Human Services shall, as appropriate and consistent with applicable law, take action to expand safe access to lower-cost imported prescription drugs by:
(a)  facilitating grants to individuals of waivers of the prohibition of importation of prescription drugs, provided such importation poses no additional risk to public safety and results in lower costs to American patients, pursuant to section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 384(j)(2);…