Organization Announcements

Organization Announcements
Editor’s Note:
Careful readers will note that the number and range of organizations now monitored in our Announcements section below has grown as the impacts of the pandemic have spread across global economies, supply chains and programmatic activity of multilateral agencies and INGOs.

 

Paul G. Allen Frontiers Group [to 10 Apr 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 10 Apr 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
News
No new digest content identified.

 

BMGF – Gates Foundation [to 10 Apr 2021]
https://www.gatesfoundation.org/ideas/media-center
Press Releases and Statements
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 10 Apr 2021]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

 

CARB-X [to 10 Apr 2021]
https://carb-x.org/
News
04.06.2021
CARB-X is funding Novel Microdevices to develop a rapid and portable diagnostic for sexually transmitted diseases including antibiotic-resistant infections
CARB-X is awarding Novel Microdevices, Inc. of Baltimore, Maryland, USA, up to $3.6 million in non-dilutive funding, and, subject to available funding, up to an additional $10.2 million if certain project milestones are met, to develop a new rapid molecular test to diagnose sexually-transmitted bacterial infections, including Chlamydia trachomatis and Neisseria gonorrhoeae.

 

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 10 Apr 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
:: Past weekly editions of Vaccines and Global Health: The Week in Review are available here.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 10 Apr 2021]
http://cepi.net/
Latest News
Do we need to update our tools assessing COVID-19 vaccine performance to work against the novel variants?
CEPI, the National Institute of Biological Standards and Control (NIBSC) and the World Health Organization (WHO) are on the search for partners to investigate.
09 Apr 2021

Covax reaches over 100 economies, 42 days after first international delivery
More than 38 million doses of vaccines from manufacturers AstraZeneca, Pfizer-BioNTech and Serum Institute of India (SII) have now been delivered.
08 Apr 2021
[See COVAX above for detail]

 

DARPA – Defense Advanced Research Projects Agency [to 10 Apr 2021
https://www.darpa.mil/news
News
No new digest content identified.

 

Duke Global Health Innovation Center [to 10 Apr 2021]
https://dukeghic.org/
WEEKLY COVID VACCINE RESEARCH UPDATE
FRIDAY, April 2, 2021

 

EDCTP [to 10 Apr 2021]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
No new digest content identified.

 

Emory Vaccine Center [to 10 Apr 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Commission [to 10 Apr 2021]
http://europa.eu/rapid/search-result.htm?query=18&locale=en&page=1
Latest
Press release 7 April 2021
Coronavirus: Commission mobilises €123 million for research and innovation to combat the threat of variants
The Commission is mobilising €123 million from Horizon Europe, the new EU research and innovation programme, for urgent research into coronavirus variants. This first emergency funding under Horizon Europe adds to a range of EU-funded research and innovation actions to fight the coronavirus and contributes to the Commission’s overall action to prevent, mitigate and respond to the impact of coronavirus variants, in line with the new European bio-defence preparedness plan HERA Incubator

 

European Medicines Agency [to 10 Apr 2021]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021 (new)
PRAC, Last updated: 09/04/2021

 

 

News: AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets (new)
PRAC, Last updated: 07/04/2021

 

European Vaccine Initiative [to 10 Apr 2021]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 10 Apr 2021]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
April 9, 2021 – Coronavirus (COVID-19) Update: April 9, 2021

April 6, 2021 – Coronavirus (COVID-19) Update: April 6, 2021

April 6, 2021 – Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System

 

Fondation Merieux [to 10 Apr 2021]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation co-organized event
Vaccine Acceptance webinars: managing vaccine misinformation in the midst of a pandemic
April 15, 2021 – Virtual Event

 

Gavi [to 10 Apr 2021]
https://www.gavi.org/
News Releases
8 April 2021
COVAX reaches over 100 economies, 42 days after first international deliver
[See COVAX above for detail]

 

GHIT Fund [to 10 Apr 2021]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
No new digest content identified.

 

Global Fund [to 10 Apr 2021]
https://www.theglobalfund.org/en/news/
News & Stories
News
Global Fund Thanks Germany for EUR 140 million Contribution
08 April 2021
The Global Fund applauds Germany’s leadership in the global response to COVID-19 and warmly welcomes an additional contribution of EUR 140 million to support Global Fund efforts to fight the COVID-19 pandemic in low- and middle-income countries and mitigate the impact on HIV, tuberculosis and malaria programs, including through deploying diagnostic tests and protecting front-line health workers.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 10 Apr 2021]
https://www.glopid-r.org/news/
News
GloPID-R observer CEPI launches funding call to develop broadly protective coronavirus vaccines
09/04/2021
With the emergence of novel SARS-CoV-2 variants and the threat of future coronavirus outbreaks, GLOPID-R observer the Coalition for Epidemic…

Call for comments on the Zika virus (ZIKV) Research and Development (R&D) Roadmap
08/04/2021
A call for comments has been launched on the draft Zika virus (ZIKV) Research and Development (R&D) Roadmap developed by…

Research priorities for Long Covid: BMC Medicine commentary highlights the need for global research coordination and stronger health systems
07/04/2021
To ensure that Long Covid does not become the lasting legacy of the Covid-19 pandemic, research must be based on…

 

Hilleman Laboratories [to 10 Apr 2021]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 10 Apr 2021]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
[Website not loading at inquiry]

 

IAVI [to 10 Apr 2021]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
No new digest content identified.

 

 

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

 

ICRC [to 10 Apr 2021]
https://www.icrc.org/en/whats-new
Selected News Releases, Statements, Reports
The Potential Human Cost of the Use of Weapons in Outer Space and the Protection Afforded by International Humanitarian Law
While space objects have been employed for military purposes since the dawn of the space era, the weaponization of outer space would increase the likelihood of hostilities in outer space, with potentially significant impacts for civilians on earth.
09 April 2021

The international community must redouble its efforts to address the challenges facing mine action
Statement of the ICRC to the UNSC about mine action and sustaining peace: Stronger partnerships for better delivery.
08-04-2021 | Statement

International Humanitarian Law Bibliography
The ICRC International Humanitarian Law Bibliography lists references to English and French publications on international humanitarian law.
06-04-2021 | Article

 

 

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

 

 

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

 

IFRC [to 10 Apr 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Middle East and North Africa
New Red Cross Red Crescent analysis shows deep inequalities in COVID-19 response across Middle East and North Africa
Beirut, 8 April 2021 (IFRC) – The International Federation of Red Cross and Red Crescent Societies (IFRC) in the Middle East and North Africa (MENA) is seeking “urgent and sizeable investment” to ensure the region’s pandemic response leaves no one behind
… New analysis released today by the IFRC highlights significant inequalities in COVID-19 vaccination rates across the MENA region. According to this analysis:
:: Less than 5 per cent of vaccine doses administered in MENA Region have been administered in the eight countries facing severe or very severe humanitarian crises.
:: Only a third (37 per cent) of doses of COVID-19 vaccine administered in MENA Region have been reported administered in countries experiencing any type of humanitarian crisis, whether conflict, complex emergencies, displacement, or others.
:: Among MENA countries that have administered any vaccine doses, the country reporting the most doses per capita, UAE, reports having administered 510 times more doses per capita than Algeria.
Hossam Khalil Elsharkawi, Regional Director of the International Federation of Red Cross and Red Crescent Societies (IFRC) in the Middle East and North Africa (MENA), said: “The Middle East and North Africa hosts some of the world’s most protracted humanitarian crises. This analysis shows that people in these settings are more likely than the general population to be infected, are more likely to die once infected, and are least likely to be appropriately supported through the response, including through vaccination campaigns.
“While there is clearly a growing recognition of the importance of equitable vaccine access, this is not yet translating into investment in all the systems that are needed to turn this ambition into a reality. The Red Cross Red Crescent Movement plan focuses on reaching the last mile and ensuring that no one is left behind. To continue to play this role, we need urgent and sizeable investment.”…

 

Institut Pasteur [to 10 Apr 2021]
https://www.pasteur.fr/en/press-area
Press release
06.04.2021
Light shed on the coordination of neural stem cell activation
In all adult vertebrates, neural stem cells can be recruited to produce new neurons in the brain.

 

IRC International Rescue Committee [to 10 Apr 2021]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
As wealthy countries look toward a return to normalcy, many impacted by conflict and crisis are experiencing significant increases in COVID-19 cases and deaths with little hope for a vaccine this year
April 7, 2021
:: With the emergence of more contagious and more deadly variants, many crisis-affected countries are experiencing significant upticks in COVID-19 cases and deaths.
:: Places like Kenya, Venezuela, Yemen, Ethiopia, and northeast Syria seeing average daily case increases of 322%, 91%, 379%, 289%, and 529% respectively between early and late March.
:: This World Health Day, we call on the international community to focus their investments on strengthening health systems in crisis-affected countries and to donate excess vaccine doses through the COVAX Facility.

 

IVAC [to 10 Apr 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
World Immunization Week 2021 Webinar
April 2021
Immunization Agenda 2030: Equitable Health Access for All During World Immunization Week 2021, the International Vaccine Access Center will co-host a panel event with Shot@Life to highlight how COVID-19 has exposed and exacerbated global health inequities, and how the new Immunization Agenda 2030 Framework for Action charts a path to equitable immunization coverage for everyone.

 

IVI [to 10 Apr 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

 

JEE Alliance [to 10 Apr 2021]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

Johns Hopkins Center for Health Security [to 10 Apr 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 10 Apr 2021]
http://www.msf.org/
Latest [Selected Announcements
DRC Ebola outbreaks
DRC’s twelfth Ebola outbreak
Crisis Update 8 Apr 2021

 

National Academy of Medicine – USA [to 10 Apr 2021]
https://nam.edu/programs/
Accessed 3 April 2021
Selected News/Programs
Expert Papers from the National Academy of Medicine Identify Lessons Learned and Compelling Needs for Public Health and Care Systems after COVID-19
April 7, 2021
In response to the devastating impact of COVID-19 on the American health system, the National Academy of Medicine (NAM) convened experts in nine sectors of health, health care, and biomedical research to review how each sector was impacted by COVID-19, identify challenges encountered in combating the pandemic, and outline what opportunities exist to reinforce, revitalize, […]

Advancing Pandemic and Seasonal Influenza Vaccine Preparedness and Response
An International Committee will inform and facilitate efforts to advance global influenza pandemic preparedness. This International Committee will provide an iterative, interactive, multi-disciplinary, expert-informed process for assessing the global impact that capabilities, technologies, processes, and policies developed for COVID-19 could have on pandemic and seasonal influenza global preparedness and response, especially regarding vaccine development.
Upcoming Events:
:: Overview of Vaccine Science: Establishing Priorities to Improve Influenza Vaccines (April 15)
:: Major Barriers to Effective Global Coordination and Financing for Influenza Vaccination- Day 1 (April 9)
:: Major Barriers to Effective Global Coordination and Financing for Influenza Vaccination- Day 2 (April 16)
Past Events:
Overview of Vaccine Science: Existing Evidence and Lessons from COVID-19 (March 30)

 

National Vaccine Program Office – U.S. HHS [to 10 Apr 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

 

NIH [to 10 Apr 2021]
http://www.nih.gov/news-events/news-releases
News Releases
NIH experts call for accelerated research to address concurrent HIV and COVID-19 pandemics
April 8, 2021 — The COVID-19 pandemic is affecting people with or at risk for HIV indirectly and directly.

NIH begins study of allergic reactions to Moderna, Pfizer-BioNTech COVID-19 vaccines
April 7, 2021 — A clinical trial is underway to determine whether people who are highly allergic or have a mast cell disorder are at increased risk for an immediate, systemic allergic reaction to the Moderna or Pfizer-BioNTech COVID-19 vaccines…

 

UN OCHA Office for the Coordination of Humanitarian Affairs [to 10 Apr 2021]
https://www.unocha.org/
Press Releases
No new digest content identified.

 

PATH [to 10 Apr 2021]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

 

Sabin Vaccine Institute [to 10 Apr 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 10 Apr 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
6 April 2021
Keeping girls in school reduces new HIV infections

 

UNDP United Nations Development Programme [to 10 Apr 2021]
http://www.undp.org/content/undp/en/home/presscenter.html
Latest from News Centre
UN calls for urgent action on debt, vaccines, around the world
Posted on April 10, 2021
Washington —The United Nations called this week for expanded debt relief to all developing countries that request it and faster, more equitable COVID-19 vaccinations to tackle “unprecedented” fallout from the ongoing COVID-19 pandemic.
“To avoid a development crisis, the world must avoid a debt crisis,” UNDP Administrator Achim Steiner said on behalf of the United Nations in statements to the World Bank and International Monetary Fund (IMF) Development Committee and to the International Monetary and Financial Committee Board of Governors, gathered virtually for their yearly Spring Meetings. “This is no time for austerity.”
Speaking on behalf of the UN Secretary-General,  Steiner also noted that that 84 percent of COVID-19 vaccines administered so far have gone to wealthier countries and urged swift measures to close major gaps in vaccine funding and production for poor countries.
While the world’s largest economies have mobilized an historic US$18 trillion in fiscal support, keeping people and economies afloat amid surging poverty, joblessness, and hunger, many developing countries cannot invest in recovery and resilience because of financing constraints, Steiner said.
“The least developed countries have spent 580 times less in per capita terms on their COVID-19 response than advanced economies. This division is starkly reflected in global access to vaccines. The work is not done until vaccines are in arms around the world and until the divergent paths of recovery correct course.”…

 

UNESCO [to 10 Apr 2021]
http://en.unesco.org/news
Selected Latest News
Let’s discuss the ethical considerations of COVID-19 vaccination rollout: Making the COVID-19 vaccine a global public good
08/04/2021
UNESCO, in partnership with Africa Centres for Disease Control and Prevention (CDC), South African Medical Research Council (SAMRC), the South African National Bioethics Committee, the Coalition of African National Medical Associations and World Health Organisation (WHO), will host a series of online workshops to discuss the equitable and timely allocation of COVID-19 vaccines in Africa.
The first workshop will take place on 14 April 2021 and will present the UNESCO Statement on Global Equity and Solidarity, and the Africa CDC’s Framework for the Fair, Equitable and Timely Allocation of COVID-19 Vaccines in Africa. How can ethical principles such as Global Solidarity, Equity, or Ubuntu be translated into Immunisation Policies and Plans in Africa?… Join the discussion. Register here.

UNESCO launches 2021 survey on public access to information
07/04/2021
UNESCO has kicked off a global survey on public access to information, putting into practice its status as the custodian agency in the UN for monitoring the right to access to information.
Using Sustainable development indicator 16.10.2, the new survey will track progress on how states are adopting and implementing legally binding guarantees for public access to information.
The 2021 survey on Access to Information will be launched during the World Bank online consultation for the next “World Development Report 2021: Data for Better Lives”.
Previous surveys by UNESCO have raised awareness that states as the duty-bearers responsible for ensuring access to information and data are often themselves in a position of having very limited data about performance of the very institutions charged with this duty.
The launch of the new survey will help to generate new data and further pinpoint where progress is needed. It will also be an opportunity to share concrete examples on how data on the monitoring of SDG 16.10.2 can improve lives and links to other SDGs…

 

UNHCR Office of the United Nations High Commissioner for Refugees [to 10 Apr 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected Announcements
UNHCR calls for equitable access to COVID-19 vaccines for refugees
7 Apr 2021
On World Health Day, UNHCR, the UN Refugee Agency, is calling for concerted international action and solidarity to ensure equitable access to COVID-19 vaccinations, including for refugees and other forcibly displaced and stateless people.
UNHCR is encouraged by the fact that 153 States have adopted vaccination strategies that include refugees. Yet, in many parts of the world, actual immunization remains a challenge, largely due to the unequal availability of vaccines and the capacity of health systems.
“The blatant imbalances observed in vaccine-sharing among States are counter-productive and shortsighted. A ‘my country first’ approach just cannot work in a pandemic that knows no borders,” said the UN High Commissioner for Refugees Filippo Grandi.
To date, some 20 countries are known to have begun inoculating refugees on an equal footing to citizens. Recent examples include Serbia and Nepal, which came on the heels of other States, such as Rwanda and Jordan.
“We commend these countries for their exemplary dedication and leadership. By including refugees in their vaccine distribution, they mitigate the risks associated with exclusion and discrimination,” Grandi said. Such risks range from consequences for the overall public health situation to limited access to services or curtailed freedom of movement…

 

UNICEF [to 10 Apr 2021]
https://www.unicef.org/media/press-releases
Selected press releases, news notes and statements
Press release 04/08/2021
COVAX reaches over 100 economies, 42 days after first international delivery
[See COVAX above for detail]

 

Statement 04/06/2021
We need speed and simplicity to remove barriers to the acquisition, manufacture and distribution of COVID-19 vaccines globally
Statement by UNICEF Executive Director Henrietta Fore
[See COVAX above for detail]

 

Unitaid [to 10 Apr 2021]
https://unitaid.org/
Featured News
No new digest content identified.

 

Vaccination Acceptance Research Network (VARN) [to 10 Apr 2021]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 10 Apr 2021]
http://www.vaccineconfidence.org/
News, Research and Reports
Coronavirus global impact
Launched April 2, 2020 and recurring every 3 days, Premise Data is utilizing its global network of Contributors to assess economic, social, and health sentiment surrounding the coronavirus (COVID-19).
[Data arrays do noy seem to loading]

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 10 Apr 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

 

Wellcome Trust [to 10 Apr 2021]
https://wellcome.ac.uk/news
News and reports
Explainer
What are ‘adverse events’ and ’emergency use authorisation’ in relation to vaccination?
8 April 2021

Explainer
What drugs are working as treatments for Covid-19?
6 April 2021

 

The Wistar Institute [to 10 Apr 2021]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

 

WFPHA: World Federation of Public Health Associations [to 10 Apr 2021]
https://www.wfpha.org/
Latest News
No new digest content identified.

 

World Bank [to 10 Apr 2021]
http://www.worldbank.org/en/news/all
Selected News, Announcements
World Bank’s Response to COVID-19 (Coronavirus) in Africa
… The World Bank has taken fast action to help African countries strengthen their pandemic response and health care systems and is now stepping up its support on vaccine purchase and deployment.
With the vaccine roll-out underway in many African countries, ensuring an adequate supply of vaccines is a priority for the region. Th e World Bank estimates that every month of delay costs the African continent $13.8 billion in lost gross domestic product.
Currently, the World Bank is preparing emergency vaccine financing projects in more than 30 African countries including Chad, the Democratic Republic of Congo, Ethiopia, Guinea-Bissau, Rwanda, and Senegal – amounting to a total of $1.85 billion. These projects focus on ensuring countries have available financial resources to equitably access vaccines; conducting readiness assessments to identify gaps and take measures to make sure vaccines reach as many people as possible; reinforcing infrastructure including cold chain equipment, trained human resources, and transport; establishing data collection systems to monitor the impact of vaccination efforts; as well as supporting behavior change campaigns to address vaccine hesitancy and increase demand.
The emergency vaccine financing follows the development of COVID-19 emergency projects in 36 countries (amounting to $988 million) which focus on strengthening prevention, expanding testing and providing medical equipment such as portable ventilators, personal protective equipment and masks, as well as building healthcare facilities, and strengthening community engagement, health systems and coordination. Additional resources (about $190 million) are being leveraged through project restructuring and existing health operations…

Date: April 08, 2021 Type: Factsheet

 

 

The World Bank Approves US$150 Million to Support COVID-19 Vaccination in Ecuador
WASHINGTON D.C., April 5, 2021 – The World Bank Board of Directors approved US$150 million in additional financing for the COVID-19 Emergency Response Project in Ecuador. This is the first World Bank- financed operation in Latin America and the Caribbean for COVID-19 vaccine procurement. The new resources will be used to purchase and distribute vaccines and to support pandemic management in the country…
Date: April 05, 2021 Type: Press Release Language: English

 

World Customs Organization – WCO [to 10 Apr 2021]
http://www.wcoomd.org/
Latest News – Selected Items
No new digest content identified.

 

World Organisation for Animal Health (OIE) [to 10 Apr 2021]
https://www.oie.int/en/for-the-media/press-releases/2021/
Press Releases
No new digest content identified.

 

WTO – World Trade Organisation [to 10 Apr 2021]
http://www.wto.org/english/news_e/news_e.htm
WTO News and Events
No new digest content identified.

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 10 Apr 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Press Releases
No new digest content identified.

 

BIO [to 10 Apr 2021]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 10 Apr 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 10 Apr 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 10 Apr 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
BIO-IFPMA Comment on COVAX No-Fault Compensation Program for COVAX Advance Market Commitment Eligible Economies
Geneva, 9 April 2021 – We commend COVAX on the launch of its Web Portal for the no-fault compensation program (NFC) for the 92 low- and middle-income countries eligible for support under the COVAX Advance Market Commitment (AMC).  The development of this international NFC system is a historic achievement, and the program will play a crucial role in advancing the prompt, equitable, and responsible administration of COVID-19 vaccines.  We recognize the immense challenges the World Health Organization (WHO) faced in designing this first-of-its-kind international system, and we appreciate that the program incorporates many of the critical design elements associated with highly-effective NFC systems.  We recommend two refinements that will maximize the effectiveness and success of this impressive program.

 

First, we support the WHO’s decision to limit compensation to serious adverse events but suggest that the COVAX NFC program cover all serious adverse events, not just permanent serious adverse events.  Doing so would align with successful national NFC systems, and would also align with the definition of “serious adverse event” adopted by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

 

Why is this refinement important to the effectiveness and success of the program?  Serious adverse events of any kind have only rarely been associated with vaccines, but those few that do occur even more seldom result in permanent injuries.  For example, anaphylaxis is a very rare but serious event that, with proper treatment, is normally resolved within a relatively short time.  It clearly fits the standard ICH definition of a serious adverse event, yet it would not always be eligible for compensation under the WHO program as currently designed.  Excluding people who experience such events would deprive them of fair compensation and could undercut public confidence in the NFC program.

 

Second, COVAX should ensure that the COVAX program is agile enough to respond to rapidly-changing global developments—such as the rise of new COVID-19 variants—including through potential extensions of the program’s coverage term.  We understand that the COVAX NFC program currently has an eligibility cutoff date of June 30, 2022 and includes additional coverage limitations tied to the date upon which vaccines receive initial regulatory authorization and the date upon which countries first receive vaccine doses.

 

Why is this refinement important to the effectiveness and success of the program?   While these coverage term restrictions may currently be appropriate, the rise of new variants and other global developments could require the introduction of new and/or modified vaccines and may significantly alter the timelines for global vaccine distribution.  Given the unpredictability of these developments, we request that the COVAX acknowledge its willingness to extend the program’s coverage term as necessary in the coming months and years.

Effective NFC systems should advance two core goals:
:: They should provide vaccine recipients with access to prompt, fair, and transparent compensation for any serious adverse events associated with vaccinations.  By achieving this goal, well-designed systems can greatly enhance vaccine confidence and expedite vaccine uptake.
:: NFC systems should mitigate the risks of time-consuming and resource-intensive vaccine liability litigation.  Reducing costly litigation provides governments and other stakeholders with the financial security necessary to carry out robust vaccination programs, while still providing vaccine recipients with timely access to compensation.  This goal is particularly important in low- and middle-income countries, were the financial risks posed by liability litigation can severely limit the implementation of vaccination programs.  By implementing the above refinements, COVAX will best be able to ensure that its program advances both of these goals.

We again commend COVAX on the announcement of its historic NFC program.  By implementing the above recommendations, the COVAX will be able to best ensure that this program plays an effective role in enhancing global vaccination efforts for the duration of the COVID-19 pandemic.  We look forward to further collaborating with the COVAX partners to advance our shared public health goals, and we welcome any opportunity to further discuss these recommendations.

 

PhRMA [to 10 Apr 2021]
http://www.phrma.org/
Selected Press Releases, Statements
Key excerpts: PhRMA submits comments to NIST in effort to safeguard intellectual property protections
April 9, 2021
PhRMA submits comments to NIST in effort to safeguard Intellectual Property protections
Earlier this week PhRMA submitted comments to the National Institute of Standards and Technology (NIST) regarding the proposed rulemaking on implementing regulations of the Bayh-Dole Act. Passed in 1980, the Bayh-Dole Act was a landmark piece of bipartisan legislation that established a uniform framework across the federal government to encourage technology transfer between universities and the private sector that has facilitated timely and efficient commercialization of early-stage research. Since its passage, it has fueled unprecedented innovation across the United States…