Africa CDC [to 15 May 2021]

Africa CDC [to 15 May 2021]
http://www.africacdc.org/
News
COMMUNIQUE OF THE HIGH-LEVEL EMERGENCY VIRTUAL MEETING OF AFRICAN MINISTERS OF HEALTH ON THE COVID-19 SITUATION IN AFRICA
14 May 2021
[Excerpt]
… THE HIGH-LEVEL MINISTERIAL MEETING:
:: WELCOMES AND RECOGNIZES the efforts by the Member States in response to COVID-19 pandemic.
:: COMMENDS the efforts of Africa CDC, WHO, partners, and AU Member States in working closely under the AFTCOR to coordinate our efforts across the continent.
:: COLLECTIVELY ENDORSES an adapted joint continental strategy with focus on enhanced Prevention, Monitoring, and Treatment (PMT) in order to meet the changing dimensions of the COVID-19 on the continent as well as the evolving nature of the global pandemic.
:: CALLS UPON all Member States to intensify their efforts for vaccination against COVID-19 as a critical component to prevent, contain and bring the pandemic to an end as quickly as possible.
:: ALSO CALL UPON AU Member States to take up their COVID-19 vaccine allocations through the African Vaccine Acquisition Task Team platform and engage with the African Export Import Bank to work out the details for the advance purchase agreement.
:: UNDERSCORES the need the protect schools and ensure schools remain opens.
:: ALSO UNDERSCORE the urgent need to protect other critical health programmes on the continent against the impact of the COVID-19 pandemic. These programmes including but not limited to HIV, TB, Malaria, and immunization efforts.
:: STRESSES the need to understand the impact of vaccine impact and safety in the continent and CALLS on AU Members States to conduct surveillance for vaccine effectiveness and safety…

China CDC

China CDC
http://www.chinacdc.cn/en/
CCDC Weekly – Weekly Reports: Current Volume (3)
2021-05-14 / No. 20
:: Methods and Applications: Trend Analysis and Intervention Effect Starting Point Detection of COVID-19 Epidemics Using Recalibrated Time Series Models — Worldwide, 2020
:: Methods and Applications: A Longitudinal Cohort Study Using a Modified Child-Pugh Score to Escalate Respiratory Support in COVID-19 Patients — Hubei Province, China, 2020

National Health Commission of the People’s Republic of China [to 15 May 2021]
http://en.nhc.gov.cn/
News
May 15: Daily briefing on novel coronavirus cases in China
On May 14, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 14 new cases of confirmed infections.

Vaccine best path to global immunity, expert says
2021-05-14

China’s Sinopharm COVID-19 vaccine safe, efficacious: WHO official
2021-05-13

WHO approval of Sinopharm vaccine set to benefit world coronavirus fight
2021-05-10

National Medical Products Administration – PRC [to 15 May 2021]
http://english.nmpa.gov.cn/news.html
News
Over 354m COVID-19 vaccine doses administered across China
2021-05-14
More than 354.27 million doses of COVID-19 vaccines had been administered across China as of Wednesday, the National Health Commission said on May 13.

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 15 May 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 15 May 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
News
No new digest content identified.

 

BMGF – Gates Foundation [to 15 May 2021]
https://www.gatesfoundation.org/ideas/media-center
Press Releases and Statements
Press release May 12, 2021
Postsecondary Value Commission Report Proposes Action to Address Disparities in Economic Returns to College with Regard to Race, Income and Gender
SEATTLE – May 12, 2021: The national Postsecondary Value Commission, supported by the Bill & Melinda Gates Foundation and managed by the Institute for Higher Education Policy (IHEP), released its final findings today using national and institutional data sources confirming wide-ranging disparity in the value of a postsecondary education in terms of race, income and gender.

Statement May 06, 2021
Statement from Gates Foundation CEO Mark Suzman: No barriers should stand in the way of equitable vaccine access
The Bill & Melinda Gates Foundation has been working urgently since January 2020 with a range of partners to help COVID-19 vaccines reach as many people as possible, as quickly as possible. Today, with the heartbreaking surges in India and Brazil, and the lack of vaccines across African countries, it is clear there’s much more to be done.
No barriers should stand in the way of equitable access to vaccines, including intellectual property, which is why we are supportive of a narrow waiver during the pandemic. Those negotiations will occur via the WTO process, led by country negotiators…

 

Bill & Melinda Gates Medical Research Institute [to 15 May 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 15 May 2021]
https://carb-x.org/
News
05.10.2021  |
CARB-X is funding Australian-biotech SpeeDx to develop a rapid point-of-care diagnostic for sexually transmitted diseases Chlamydia trachomatis and Neisseria gonorrhoeae
CARB-X is awarding SpeeDx, a diagnostics company in Sydney, Australia, up to $1.8 million to develop a rapid test for Chlamydia trachomatis and Neisseria gonorrhoeae, sexually transmitted bacteria that can cause serious infections and that are spreading around the world at alarming rates. SpeeDx is also eligible for $1.9 million in additional funds from CARB-X if the project achieves certain milestones, subject to available funds.

 

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 15 May 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
:: Past weekly editions and posting of all segments of Vaccines and Global Health: The Week in Review are available here.
:: [NEW] Informed Consent: A Monthly Review – May 2021 is now posted here

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 15 May 2021]
http://cepi.net/
Latest News
COVAX Manufacturing Task Force to tackle vaccine supply challenges
COVAX has set up a “Manufacturing Task Force” to identify and resolve issues impeding equitable access to vaccines through COVAX.
14 May 2021

CEPI expands global footprint of its COVID-19 vaccine lab network, and opens testing against Variants of Concern
From July 2021, all COVID-19 vaccine developers are invited to use the network to evaluate their candidate vaccines against SARS-CoV-2 variants.
14 May 2021

The vaccines and the variants: CEPI’s work to tackle an evolving threat
The emergence of SARS-CoV-2 variants underscores the urgent need to double down our efforts to bring COVID-19 under control through the deployment of safe and effective vaccines globally.
11 May 202

 

DARPA – Defense Advanced Research Projects Agency [to 15 May 2021
https://www.darpa.mil/news
News
No new digest content identified.

 

Duke Global Health Innovation Center [to 15 May 2021]
https://dukeghic.org/
WEEKLY COVID VACCINE RESEARCH UPDATE
Last dated update: FRIDAY, April 16, 2021

 

EDCTP [to 15 May 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 15 May 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Vaccine Initiative [to 15 May 2021]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 15 May 2021]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
May 14, 2021 – Coronavirus (COVID-19) Update: May 14, 2021

May 11, 2021 – Coronavirus (COVID-19) Update: May 11, 2021

May 11, 2021 – FDA In Brief: FDA Finalizes Guidance with Internationally Harmonized Recommendations to Further Support Safe, High-Quality Human Drug Products

May 10, 2021 – Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic
[See U.S. COVID Actions above for detail]

 

Fondation Merieux [to 15 May 2021]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation co-organized event
Evidence to actions: countries and communities driving adaptive, evidence-informed approaches to end cholera
May 20, 2021 – Virtual Event

 

Gavi [to 15 May 2021]
https://www.gavi.org/
News Releases
12 May 2021
Japan to host Gavi’s COVAX Advance Market Commitment (AMC) Summit
Geneva, 12 May 2021 – The Government of Japan yesterday announced that it will host the virtual Gavi COVAX Advance Market Commitment (AMC) Summit on June 2nd 2021. The event, co-hosted by Japanese Prime Minister H.E. Yoshihide Suga and José Manuel Barroso, Chair of the Gavi Board, will aim to secure at least US $8.3 billion for 2020-21 in order to accelerate access to 1.8 billion COVID-19 vaccine doses for lower-income economies via the Gavi COVAX Advance Market Commitment by raising an additional US$ 2 billion from donors and the private sector in addition to US$ 6.3 billion raised before the campaign was launched at the “One World Protected” event on April 15th…

10 May 2021
Corporations, charities and governments step up support for equitable COVID-19 vaccine access at Vax Live concert
:: Over US$ 60 million raised for the procurement of COVID-19 vaccines for lower-income countries via the Gavi COVAX Advance Market Commitment (COVAX AMC)
:: The United Arab Emirates and Croatia have also committed millions of COVID-19 vaccines doses for lower-income countries
:: The pledges were announced at Global Citizen’s Vax Live Concert on Saturday, co-hosted by Selena Gomez and featuring messages from Prince Harry, the Duke of Sussex, His Holiness Pope Francis and several Heads of State

 

GHIT Fund [to 15 May 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 15 May 2021]
https://www.theglobalfund.org/en/news/
News & Stories
News
Global Fund 45th Board Meeting Reports Continued Progress Despite COVID-19 Pandemic
12 May 2021
The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria overwhelmingly praised the continued progress of the Global Fund in the past year despite the challenges of the COVID-19 pandemic.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 15 May 2021]
https://www.glopid-r.org/news/
News
No new digest content identified.

 

Hilleman Laboratories [to 15 May 2021]
http://www.hillemanlabs.org/
Website not responding at inquiry

 

Human Vaccines Project [to 15 May 2021]
http://www.humanvaccinesproject.org/media/press-releases/
HVP COVID Report
Vaccines in a Year? How About a Few Months?
Nick Jackson, MSc., DLSHTM, Ph.D.
Head of Programs and Technology, Vaccine Research and Development
Coalition for Epidemic Preparedness Innovations (CEPI)

 

IAVI [to 15 May 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 15 May 2021]
https://www.icrc.org/en/whats-new
Selected News Releases, Statements, Reports
No new digest content identified.

 

 

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
IGBA Applauds UK MHRA Biosimilar Guidance Revision: Science-driven Evolution for Sustainable Access to Biologics (May 2021)
11.5.2021
The International Generic and Biosimilar medicines Association (IGBA), which represents global manufacturers of generic and biosimilar medicines, welcomes the UK MHRA publication of its updated guidance on the licensing of biosimilar products (10 May 2021). This publication marks a positive milestone in the evolution of evidence requirements for biosimilar approval through the removal of the default need for a comparative efficacy trial, instead basing approval on a comprehensive comparability exercise, including a comparative pharmacokinetics (PK) trial.

 

 

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

 

IFRC [to 15 May 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Bangladesh, India, Laos, Nepal, Philippines
Asia: 5.9 million COVID infections overwhelm hospitals
Kuala Lumpur/Delhi/Geneva, 12 May 2021 – The world’s fastest surge of COVID-19 is pushing hospitals and health systems to the brink of collapse as Asia has fast become the global COVID-19 hotspot, suffering more than twice as many new infections than a …
12 May 2021

 

Institut Pasteur [to 15 May 2021]
https://www.pasteur.fr/en/press-area
Press release
11.05.2021
Genetics: Biosynthesis pathway of a new DNA nucleobase elucidated
DNA is composed of nucleobases represented by the letters A, T, G and C. They form the basis of the genetic code and…

 

IOM / International Organization for Migration [to 15 May 2021]
http://www.iom.int/press-room/press-releases
News
IOM Supports the UN COVID-19 Vaccination Roll-Out in Yemen
2021-05-11 16:31
Aden – The International Organization for Migration (IOM) has begun its support to the United Nations (UN) COVID-19 vaccination roll-out in Yemen where cases have recently surged. The Organization is providing vaccinations at five health centres in Aden, Ma’rib, Shabwah, Taiz and Lahj.
Yemen received 360,000 COVID-19 vaccine doses through the COVAX Facility on 31 March. The roll-out of the vaccination campaign began on 20 April…

 

IRC International Rescue Committee [to 15 May 2021]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
Analysis shows 87% of COVID-19 vaccine doses have been given in wealthier countries, despite surges in cases in conflict-affected countries, warns IRC
May 12, 2021

 

IVAC [to 15 May 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
Webinar: Addressing challenges in vaccination in fragile contexts
Register Now
Description: With COVID-19 vaccines now available worldwide, reaching underserved and vulnerable populations is a priority under the Immunization Agenda 2030 (IA2030). Numerous challenges and operational issues have presented themselves in fragile contexts including vaccine access, risk of vaccine preventable diseases, and vaccine hesitancy. Join the IA2030 Strategic Priority 5 working group for a 90-minute webinar (May 21 at 7:30am ET / 13:30 CET) hosted by the International Vaccine Access Center to discuss vaccinating against COVID-19 in fragile contexts in coordination with the launch of IA2030 at the World Health Assembly.

 

IVI [to 15 May 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

 

JEE Alliance [to 15 May 2021]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

Johns Hopkins Center for Health Security [to 15 May 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
Johns Hopkins Center for Health Security and National Organizations Share Strategies to Improve Crisis Standards of Care Implementation During Future COVID-19 Surges and Beyond
May 13, 2021
[See Milestones above for full text]

 

MSF/Médecins Sans Frontières [to 15 May 2021]
http://www.msf.org/
Latest [Selected Announcements
More oxygen supplies needed to avoid COVID-19 patients “gasping for air”
Press Release 10 May 2021

 

National Academy of Medicine – USA [to 15 May 2021]
https://nam.edu/programs/
Selected News/Programs
Upcoming Events:
National Organizations Share Strategies to Improve Crisis Standards of Care Implementation During Future COVID-19 Surges and Beyond
May 13, 2021
[See Milestones above for detail]

 

National Vaccine Program Office – U.S. HHS [to 15 May 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

 

NIH [to 15 May 2021]
http://www.nih.gov/news-events/news-releases
News Releases
Gene therapy restores immune function in children with rare immunodeficiency
May 11, 2021 — Researchers found that 48 of 50 children retained their replenished immune system function two to three years later and did not require additional treatments for ADA-SCID.

 

UN OCHA Office for the Coordination of Humanitarian Affairs [to 15 May 2021]
https://www.unocha.org/
Press Releases
13 May 2021
Humanitarian Coordinator condemns killing of an aid worker in Budi, Eastern Equatoria

10 May 2021
Humanitarian Coordinator condemns attacks against humanitarian workers in Renk, Upper Nile

 

PATH [to 15 May 2021]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

 

Sabin Vaccine Institute [to 15 May 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 15 May 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
14 May 2021
Protecting prisoners from HIV and COVID-19 in Mexico

11 May 2021
Community-led HIV services stepped up in the Philippines during the COVID-19 pandemic

10 May 2021
UNAIDS saddened by the death of Smarajit Jana

 

UNDP United Nations Development Programme [to 15 May 2021]
http://www.undp.org/content/undp/en/home/presscenter.html
Latest from News Centre
No new digest content identified.

 

UNHCR Office of the United Nations High Commissioner for Refugees [to 15 May 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected News Releases, Announcements
UNHCR, aid partners call for renewed and strong support for the Rohingya refugees
14 May 2021
… With the refugee crisis in its fourth year, Bangladesh needs robust and sustained international support to ensure the safety and wellbeing of stateless Rohingya refugees. This must not become a forgotten crisis. Both Rohingya refugees and Bangladesh, having generously hosted them for decades, must see the world standing with them.
Adding to the complexity of this crisis, the COVID-19 pandemic has compounded vulnerabilities for refugees and host communities alike. To date, the Government of Bangladesh, with the support of the humanitarian community, has effectively managed the COVID-19 response and the spread of the disease in the Rohingya camps and surrounding areas, though the trajectory of the virus remains unpredictable. A coordinated and inclusive response has saved lives. However, it is critical to ensure the continued delivery of all humanitarian assistance and protection services…

 

UNICEF [to 15 May 2021]
https://www.unicef.org/media/press-releases
Selected Press Releases, Statements
Statement 05/10/2021
UNICEF Executive Director Henrietta Fore’s remarks at the European Commission High-Level Conference on the Mental Health Impact of COVID-19
As prepared for delivery
… “Emerging evidence indicates that the mental health impacts will be significant and long-lasting. Especially in the poorest countries and neighbourhoods. And for the most disadvantaged children — those living with disabilities, migrants and refugees, ethnic minorities, or those living in humanitarian settings like conflicts.
“The situation is no different in Europe. In fact, one in five adolescents in Europe is experiencing mental health problems.
“A recent OECD survey of youth organizations found that poor mental health is among the biggest impacts of COVID-19.
“And a recent UNICEF rapid review of the impact of COVID on children and adolescents across 77 countries — including 20 European countries — found that children and adolescents are reporting increased stress, anxiety, and substance use.
“They’re out of school. They’re not seeing their friends. They’re not accessing recreational and social activities. They’re facing abuse or neglect. And so often, they’re afraid of reaching out for help because of cultural norms and stigma, which remains very high.
“At the same time, these young people are coming up against a barrier that affects every person struggling with their mental health — a lack of services.
“All countries — rich and poor alike — are facing a huge gap between mental health needs and access to quality services…”

 

Unitaid [to 15 May 2021]
https://unitaid.org/
Featured News
13 May 2021
Unitaid supports new Global Initiative to end Cryptococcal Meningitis deaths by 2030
Unitaid is pleased to support the new Global Initiative to end Cryptococcal Meningitis deaths by 2030, launched on May 12th 2021 by key partners in the Cryptococcal Meningitis Advocacy Group. This target will help bring renewed focus on preventing the deaths of those living with HIV.
Cryptococcal Meningitis (CM) is a major cause of mortality among people living with HIV, accounting for 15% of the global 690,000 AIDS-related deaths in 2019 alone. An opportunistic infection, it primarily impacts those with weakened immune systems and is fatal if left untreated…

 

Vaccination Acceptance Research Network (VARN) [to 15 May 2021]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 15 May 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).

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 15 May 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

 

Wellcome Trust [to 15 May 2021]
https://wellcome.ac.uk/news
News and reports
No new digest content identified.

 

The Wistar Institute [to 15 May 2021]
https://www.wistar.org/news/press-releases
Press Releases
Press Release May. 11, 2021
The Wistar Institute Receives Transformative National Science Foundation Grant to Expand and Accelerate STEM Training Program
Impactful, inclusive workforce development program will develop a pipeline of young scientists for careers in growing life sciences sector.

 

WFPHA: World Federation of Public Health Associations [to 15 May 2021]
https://www.wfpha.org/
Latest News
No new digest content identified.

 

World Bank [to 15 May 2021]
http://www.worldbank.org/en/news/all
Selected News, Announcements
World Bank Redeploys $153 Million to Support Pakistan’s COVID-19 Vaccine Drive
WASHINGTON, May 13, 2021—The World Bank’s Board of Executive Directors today approved the restructuring of the Pandemic Response Effectiveness in Pakistan (PREP) project, originally approved in April 2020…
Date: May 13, 2021 Type: Press Release

Antimicrobial Resistance (AMR)
Antimicrobial Resistance (AMR) Antimicrobials are drugs – such as antibiotics – that kill or control disease-causing microbes. Antimicrobial resistance (AMR) occurs when microbes mutate or adapt in…
Date: May 13, 2021 Type: Brief

Widespread Informality Likely to Slow Recovery from COVID-19 in Developing Economies
Study Finds One-Third of Economic Activity Occurs Outside Governments’ Line of Sight WASHINGTON, May 11, 2021—A strikingly large percentage of workers and firms operate outside the line of sight of governments…
Date: May 11, 2021 Type: Press Release Language

 

World Customs Organization – WCO [to 15 May 2021]
http://www.wcoomd.org/
Latest News – Selected Items
No new digest content identified.

 

World Organisation for Animal Health (OIE) [to 15 May 2021]
https://www.oie.int/en/for-the-media/press-releases/2021/
Press Releases
No new digest content identified.

 

WTO – World Trade Organisation [to 15 May 2021]
http://www.wto.org/english/news_e/news_e.htm
WTO News and Events
Bolivia outlines vaccine import needs in use of WTO flexibilities to tackle pandemic
12 May 2021
The government of Bolivia has formally notified the WTO of the country’s need to import COVID-19 vaccines, taking another step towards using flexibilities in WTO intellectual property rules as part of its pandemic response.
Bolivia notified the WTO it needed to import 15 million doses of a vaccine under the legal system introduced in a 2017 amendment to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). That amendment, which created Article 31bis of the TRIPS Agreement, provides an additional legal pathway for import-reliant countries to access affordable medicines, vaccines and other pharmaceutical products.
Bolivia’s submission follows through on its February notification signalling that it intended to exercise the flexibilities under the amendment.
Bolivia’s notification opens up the possibility of importing the needed vaccines from any one of around 50 WTO members that have put in place domestic laws providing for the production and export of medicines made under compulsory licence through this system…

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 15 May 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Press Releases
No new digest content identified.

 

BIO [to 15 May 2021]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 15 May 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 15 May 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 15 May 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
COVID-19 Biopharmaceutical Industry – Regulatory Guiding Principles (May 2021)
Published on: 11 May 2021
[Formatting/text-bolding from original]
On 14 May 2020, we released our first Regulatory Guiding Principles in the unprecedented and unknown context of the COVID-19 pandemic. One year on and we are still facing the impact of this public health emergency, yet we have seen many advancements and successes. New vaccines against COVID-19 are now available, and multiple new therapeutic medicines are in various stages of the pharmaceutical pipeline. The timelines and pressure behind research and development efforts at such a global scale have never been seen before.
With all the progress that has been made against COVID-19, we risk losing sight of the other activities that transpired to ensure continued biopharmaceutical research, patient supply and access to medicines and vaccines for other conditions than COVID-19. Biopharmaceutical companies were operating and manufacturing in an environment with supply chains that were greatly impacted.
One year ago, we reiterated our continued commitments to four principles focusing on partnership and collaboration, progressing research, maintaining supply, and meeting quality and safety standards. Today, we are still honoring those commitments and are working to implement the best practices and lessons learnt by building stronger systems for the future of global health. The importance of these Regulatory Guiding Principles is clearly evident in what has been achieved during the past, very challenging year.

 

Working in partnership and collaboration with national regulatory authorities (NRAs) to define the best science-based regulatory strategies for ensuring the availability of COVID-19 medicines and vaccines – We are engaging with NRAs and regulatory coalitions to provide input, as well as feedback, on regulatory agilities, streamlined processes, rolling reviews and reliance principles implemented to accelerate the development and registration of COVID-19 medicines and vaccines. These lessons learned, along with further development and use of digital technologies, will help to modernize the current regulatory environment to better adapt to scientific and technical innovations in a sustainable fashion while providing best practices for future pandemic preparedness.

 

Progressing research into new treatments and prevention of other conditions – Lockdowns, movement restrictions, and stay-at home recommendations redirected health resources to the front line and away from new and ongoing clinical research for non-COVID-19 treatments. Patient enrollment in new clinical trials and access to existing clinical research sites were initially affected. Keeping participants safe and maintaining clinical trial integrity were priorities and implementation of new technologies like remote monitoring helped improve our recruitment of volunteers, clinical trials conduct, and monitoring and data capture.

 

Maintaining supply of medicines and vaccines – The manufacture of a medicine frequently requires more than 200 material components, along with a range of technologies. While an initial surge in global demand led to some acute shortages for these components, supply chains overall demonstrated significant resilience during the pandemic. We will continue to work with our partners to identify solutions that address the resilience and reliability of global supply as supported by predictable and agile regulatory processes and requirements.

 

Ensuring all our medicines and vaccines continue to meet appropriate standards for quality and safety – Quality manufacturing and patient safety monitoring are fundamental to our work and to public health. Even though the biopharmaceutical industry experienced various disruptions to ‘business as usual’ during the pandemic, quality, safety and efficacy of the medicines and vaccines we manufacture remained a key priority. Engagement with regulatory stakeholders will continue to ensure that quality and high-level standards are met.

 

PhRMA [to 15 May 2021]
http://www.phrma.org/
Selected Press Releases, Statements
New polling shows Americans are sounding the alarm on the TRIPS IP waiver
May 14, 2021
Once you peel back the layers of the TRIPS waiver and understand the risks to health and safety, recent data shows that Americans want a better way.
Blog Post

The Biden Administration allows politics to upend a pragmatic pandemic response
May 14, 2021
Not only will this policy do nothing to help save lives globally, it could have a damaging impact for American patients.
Blog Post

Journal Watch

Journal Watch
Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focu-s on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.
If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

Ending the HIV Epidemic

AMA Journal of Ethics
Volume 23, Number 5: E371-433 May 2021
https://journalofethics.ama-assn.org/issue/ending-hiv-epidemic

 

Ending the HIV Epidemic
A human immunodeficiency virus (HIV) epidemic began in the United States in the 1970s. “Ending the HIV Epidemic: A Plan for America” was launched in October 2019 by the US Department of Health and Human Services, with the goal of stopping the spread of HIV by 2030. Accomplishing this goal demands not only expanding existing programs, but recognizing and responding to clinically, ethically, socially, and culturally relevant features of contemporary patients’ experiences of stigma, oppression, and living with HIV. This issue considers ethical and clinical complexities patients and clinicians encounter in HIV care today.

Taking stock of the availability and functions of National Ethics Committees worldwide

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 15 May 2021)

 

Taking stock of the availability and functions of National Ethics Committees worldwide
National Ethics Committees (NECs) offer important oversight and guidance functions and facilitate public debate on bioethical issues. In an increasingly globalized world where technological advances, multi-national research collaborations, and pandemics are creating ethical dilemmas that transcend national borders, coordination and the joining of efforts among NECs are key. The purpose of this study is to take stock of the current NEC landscape, their varying roles and missions, and the range of bioethical topics on which they deliberated since their inception
Authors: Patrik Hummel, Taghreed Adam, Andreas Reis and Katherine Littler
Citation: BMC Medical Ethics 2021 22:56
Content type: Research article
Published on: 10 May 2021

Knowledge, attitudes and uptake related to influenza vaccine among healthcare workers during the 2018–2019 influenza season in Tunisia

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 15 May 2021)

 

Knowledge, attitudes and uptake related to influenza vaccine among healthcare workers during the 2018–2019 influenza season in Tunisia
The influenza vaccine (IV) is considered the most effective strategy to prevent seasonal influenza infection and annual vaccination of healthcare workers (HCWs) is recommended by the World Health Organization …
Authors: Ines Cherif, Ghassen Kharroubi, Leila Bouabid, Adel Gharbi, Aicha Boukthir, Nissaf Ben Alaya, Afif Ben Salah and Jihene Bettaieb
Citation: BMC Public Health 2021 21:907
Content type: Research
Published on: 13 May 2021

Emergence and rapid transmission of SARS-CoV-2 B.1.1.7 in the United States

Cell
May 13, 2021 Volume 184 Issue 10 p2525-2796
https://www.cell.com/cell/current

 

Articles
Emergence and rapid transmission of SARS-CoV-2 B.1.1.7 in the United States
Nicole L. Washington, et al.
Genomic epidemiology analyses explain the introduction and transmission of the B.1.1.7 variant of SARS-CoV-2 into the US, with projections for it to soon be the dominant strain in the country.

Introduction to collection: confronting the challenges of health research in humanitarian crises

Conflict and Health
http://www.conflictandhealth.com/
[Accessed 15 May 2021]

 

Commentary Open Access Published: 14 May 2021
Introduction to collection: confronting the challenges of health research in humanitarian crises
Authors: Amit S. Mistry, Brandon A. Kohrt, Blythe Beecroft, Nalini Anand and Iman Nuwayhid
Background
Humanitarian crises, such as armed conflict, forced displacement, natural disasters, and major disease outbreaks, take a staggering toll on human health, especially in low-resource settings. Yet there is a dearth of robust evidence to inform the governments, non-governmental organizations (NGOs), and other humanitarian organizations on how to best respond to them. The Fogarty International Center of the U.S. National Institutes of Health commissioned a collection of Research in Practice articles that highlights the experiences of scientists conducting research in the context of humanitarian crises. Unlike traditional research papers, the case analyses in this collection go beyond what research was completed and focus on why the research was important and how it was conducted in these extremely challenging settings.
Overview of papers
As of May 8, 2021, 18 papers have been published in the collection, with an additional 5 under review. One manuscript was not submitted by the author due to competing demands. Individual papers are published across two journals and a joint landing page for the collection is accessible at https://www.biomedcentral.com/collections/lessonsfromthefield. The landing page will be updated as manuscripts complete the review process.

Ripple effects of research capacity strengthening: a study of the effects of a project to support test facilities in three African countries towards Good Laboratory Practice certification

Gates Open Research
https://gatesopenresearch.org/browse/articles
[Accessed 15 May 2021]

 

Research Article metrics Revised
Ripple effects of research capacity strengthening: a study of the effects of a project to support test facilities in three African countries towards Good Laboratory Practice certification [version 2; peer review: 1 approved, 1 approved with reservations, 1 not approved]
Sara Begg, Alexandra Wright, Graham Small, Diabate Abdoulaye, William Kisinza, Benjamin Koudou, Sarah Moore, Franklin Mosha, Constant Edi, Matthew Kirby, Patrick Kija, Robert Malima, Jason Moore, Imelda Bates
Peer Reviewers Michael Käser; Adedayo O. Oduola; Elizabeth Hunsperger
Funder – Bill and Melinda Gates Foundation
LATEST VERSION PUBLISHED 10 May 202

Compliance of WHO and UNICEF estimates of national immunization coverage (WUENIC) with Guidelines for Accurate and Transparent Health Estimates Reporting (GATHER) criteria

Gates Open Research
https://gatesopenresearch.org/browse/articles
[Accessed 15 May 2021]

 

Research Article metrics AWAITING PEER REVIEW
Compliance of WHO and UNICEF estimates of national immunization coverage (WUENIC) with Guidelines for Accurate and Transparent Health Estimates Reporting (GATHER) criteria [version 1; peer review: awaiting peer review]
M. Carolina Danovaro-Holliday, Marta Gacic-Dobo, Mamadou S. Diallo, Padraic Murphy, David W. Brown
Peer Reviewers Invited
Funder – Bill and Melinda Gates Foundation
PUBLISHED 10 May 2021

Covid-19 in the Caribbean: lessons learned from the ongoing international medical and scientific cooperation

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 15 May 2021]

 

Covid-19 in the Caribbean: lessons learned from the ongoing international medical and scientific cooperation
Authors: Dabor Resiere, Hossein Mehdaoui, Hedda Dyer, Cyrille Chabartier, André Cabié, Jocelyn Inamo, Keats Compton, Rémi Neviere, Bruno Megarbane and Hatem Kallel
Content type: Commentary
10 May 2021

Disability inclusion in humanitarian action

Humanitarian Exchange Magazine
Number 78, October 2020
https://odihpn.org/magazine/inclusion-of-persons-with-disabilities-in-humanitarian-action-what-now/

 

Disability inclusion in humanitarian action
by HPN October 2020
The theme of this edition of Humanitarian Exchange, co-edited with Sherin Alsheikh Ahmed from Islamic Relief Worldwide, is disability inclusion in humanitarian action. Persons with disabilities are not only disproportionately impacted by conflicts, disasters and other emergencies, but also face barriers to accessing humanitarian assistance. At the same time, global commitments and standards and the IASC Guidelines on the inclusion of persons with disabilities in humanitarian action all emphasise how persons with disabilities are also active agents of change. Disability and age-focused organisations have led on testing and demonstrating how inclusion can be done better. Yet despite this progress, challenges to effective inclusion remain.

As Kirstin Lange notes in the lead article, chief among these challenges is humanitarian agencies’ lack of engagement with organisations of persons with disabilities. Simione Bula, Elizabeth Morgan and Teresa Thomson look at disability inclusion in humanitarian response in the Pacific, and Kathy Al Jubeh and Alradi Abdalla argue for a ‘participation revolution’, building on learning from the gender movement. Tchaurea Fleury and Sulayman AbdulMumuni Ujah outline how the Bridge Article 11 training initiative is encouraging constructive exchange between humanitarian and disability actors. The lack of good, disaggregated data is highlighted by Sarah Collinson; Frances Hill, Jim Cranshaw and Carys Hughes emphasise the need for training resources in local languages and accessible formats; and Sophie Van Eetvelt and colleagues report on a review of the evidence on inclusion of people with disabilities and older people.

Rebecca Molyneux and co-authors analyse the findings of a review of a DFID programme in north-east Nigeria, while Carolin Funke highlights the importance of strategic partnerships between disability-focused organisations, drawing on her research in Cox’s Bazar. Sherin Alsheikh Ahmed describes Islamic Relief Worldwide’s approach to mainstreaming protection and inclusion, while Pauline Thivillier and Valentina Shafina outline IRC’s Client Responsive Programming. The edition ends with reflections by Mirela Turcanu and Yves Ngunzi Kahashi on CAFOD’s SADI approach.

Neutralizing Antibodies Against SARS-CoV-2 Variants After Infection and Vaccination

JAMA
May 11, 2021, Vol 325, No. 18, Pages 1813-1912
https://jamanetwork.com/journals/jama/currentissue

 

Research Letter
Neutralizing Antibodies Against SARS-CoV-2 Variants After Infection and Vaccination
Venkata Viswanadh Edara, PhD; William H. Hudson, PhD; Xuping Xie, PhD; et al.
free access
JAMA. 2021;325(18):1896-1898. doi:10.1001/jama.2021.4388
This study examines the neutralizing antibody response to 4 SARS-CoV-2 variants in infected and vaccinated individuals.

Spike Antibody Levels of Nursing Home Residents With or Without Prior COVID-19 3 Weeks After a Single BNT162b2 Vaccine Dose

JAMA
May 11, 2021, Vol 325, No. 18, Pages 1813-1912
https://jamanetwork.com/journals/jama/currentissue

 

Spike Antibody Levels of Nursing Home Residents With or Without Prior COVID-19 3 Weeks After a Single BNT162b2 Vaccine Dose
Hubert Blain, MD, PhD; Edouard Tuaillon, MD, PhD; Lucie Gamon; et al.
free access has active quiz
JAMA. 2021;325(18):1898-1899. doi:10.1001/jama.2021.6042
This study compares IgG antibody levels after a single dose of the BNT162b2 (Pfizer-BioNTech) vaccine in nursing home residents with vs without prior COVID-19.

Influenza Vaccination and Hospitalization Outcomes Among Older Patients With Cardiovascular or Respiratory Diseases

Journal of Infectious Diseases
Volume 223, Issue 7, 1 April 2021
https://academic.oup.com/jid/issue/223/7

 

VIRUSES
Influenza Vaccination and Hospitalization Outcomes Among Older Patients With Cardiovascular or Respiratory Diseases
Yuanjie Pang, Qi Wang, Min Lv, Mengke Yu, Ming Lu
The Journal of Infectious Diseases, Volume 223, Issue 7, 1 April 2021, Pages 1196–1204, https://doi.org/10.1093/infdis/jiaa493
Influenza vaccination was associated with lower risk of in-hospital death among patients hospitalized for cardiovascular or respiratory disease, lower risk of readmission among patients hospitalized for cardiovascular disease, and lower direct medical costs for both cardiovascular and respiratory diseases.

One-Year Decline of Poliovirus Antibodies Following Fractional-Dose Inactivated Poliovirus Vaccine

Journal of Infectious Diseases
Volume 223, Issue 7, 1 April 2021
https://academic.oup.com/jid/issue/223/7

 

One-Year Decline of Poliovirus Antibodies Following Fractional-Dose Inactivated Poliovirus Vaccine
Ali Faisal Saleem, Ondrej Mach, Mohammad Tahir Yousafzai, Zaubina Kazi, Attaullah Baig
The Journal of Infectious Diseases, Volume 223, Issue 7, 1 April 2021, Pages 1214–1221, https://doi.org/10.1093/infdis/jiaa504
A significant decline in antibody titers 12 months following the second IPV dose was observed. The slope of decline was similar for full IPV and fIPV recipients, providing further evidence that fIPV is a viable option for IPV dose sparing.

Efficacy of a low-dose candidate malaria vaccine, R21 in adjuvant Matrix-M, with seasonal administration to children in Burkina Faso: a randomised controlled trial

The Lancet
May 15, 2021 Volume 397 Number 10287 p1781-1858, e12-e14
https://www.thelancet.com/journals/lancet/issue/current

 

Articles
Efficacy of a low-dose candidate malaria vaccine, R21 in adjuvant Matrix-M, with seasonal administration to children in Burkina Faso: a randomised controlled trial
Mehreen S Datoo, et al.
Background
Stalled progress in controlling Plasmodium falciparum malaria highlights the need for an effective and deployable vaccine. RTS,S/AS01, the most effective malaria vaccine candidate to date, demonstrated 56% efficacy over 12 months in African children. We therefore assessed a new candidate vaccine for safety and efficacy.
Interpretation
R21/MM appears safe and very immunogenic in African children, and shows promising high-level efficacy.

Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data

The Lancet
May 15, 2021 Volume 397 Number 10287 p1781-1858, e12-e14
https://www.thelancet.com/journals/lancet/issue/current

 

Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data
Eric J Haas, et al
Interpretation
Two doses of BNT162b2 are highly effective across all age groups (≥16 years, including older adults aged ≥85 years) in preventing symptomatic and asymptomatic SARS-CoV-2 infections and COVID-19-related hospitalisations, severe disease, and death, including those caused by the B.1.1.7 SARS-CoV-2 variant. There were marked and sustained declines in SARS-CoV-2 incidence corresponding to increasing vaccine coverage. These findings suggest that COVID-19 vaccination can help to control the pandemic.

Problems with traffic light approaches to public health emergencies of international concern

The Lancet
May 15, 2021 Volume 397 Number 10287 p1781-1858, e12-e14
https://www.thelancet.com/journals/lancet/issue/current

 

Viewpoint
Problems with traffic light approaches to public health emergencies of international concern
Clare Wenham, et al.
…Conclusion
The PHEIC mechanism is a potentially powerful and unique normative tool within the international system to spur collective action. However, PHEICs and the IHR are not perfect. The problems with PHEIC declarations are not about insufficient gradients of a health emergency. Instead, the tension within this global health security mechanism results from states’ refusal to engage in collective action in response to expert advice from an international organisation, particularly when seeing action as against short-term interests: a classic problem in international relations.
Although a non-binary PHEIC might appeal, to some governments and WHO, analysing similar efforts suggests that traffic light systems might only be useful at slowing traffic. A tiered or regional system will introduce bigger problems into global health diplomacy.

Leave no one behind: ensuring access to COVID-19 vaccines for refugee and displaced populations

Nature Medicine
Volume 27 Issue 5, May 2021
https://www.nature.com/nm/volumes/27/issues/5

 

Comment | 19 April 2021
Leave no one behind: ensuring access to COVID-19 vaccines for refugee and displaced populations
Ensuring access to vaccines against COVID-19 for refugee and displaced populations and addressing health inequities are vital for an effective pandemic response.
Monette Zard, Ling San Lau, S. Patrick Kachur

COVID-19 vaccine rumors and conspiracy theories: The need for cognitive inoculation against misinformation to improve vaccine adherence

PLoS One
http://www.plosone.org/
[Accessed 15 May 2021]

 

COVID-19 vaccine rumors and conspiracy theories: The need for cognitive inoculation against misinformation to improve vaccine adherence
Md Saiful Islam, Abu-Hena Mostofa Kamal, Alamgir Kabir, Dorothy L. Southern, Sazzad Hossain Khan, S. M. Murshid Hasan, Tonmoy Sarkar, Shayla Sharmin, Shiuli Das, Tuhin Roy, Md Golam Dostogir Harun, Abrar Ahmad Chughtai, Nusrat Homaira, Holly Seale
Research Article | published 12 May 2021 PLOS ONE
https://doi.org/10.1371/journal.pone.0251605

Characteristics of Misinformation Spreading on Social Media During the COVID-19 Outbreak in China: A Descriptive Analysis

Risk Management and Healthcare Policy
https://www.dovepress.com/risk-management-and-healthcare-policy-archive56
[Accessed 15 May 2021]

 

Original Research
Characteristics of Misinformation Spreading on Social Media During the COVID-19 Outbreak in China: A Descriptive Analysis
Chen K, Luo Y, Hu A, Zhao J, Zhang L
Published Date: 10 May 2021

Israel’s COVID-19 endgame

Science
14 May 2021 Vol 372, Issue 6543
http://www.sciencemag.org/current.dtl

 

Editorial
Israel’s COVID-19 endgame
By Ran D. Balicer, Reut Ohana
Science14 May 2021 : 663
Summary
As several countries now confront COVID-19 surges, Israel may be crossing over to other side of the pandemic. Whereas 5.5 million new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections were reported globally last week, Israel reported only 398 (compared with >50,000 in January). Already, 54% of Israel’s 9.2 million citizens have been fully vaccinated, considerably more than in most other countries. In the coming months, as restrictions continue to ease, the country should be optimistic, yet cautious, as risks of resurgence persist. Israel thus may well be an early case study for favorable outcomes of a mass-vaccination campaign.