Monthly Archives: September 2021

Process evaluation of complex interventions in chronic and neglected tropical diseases in low- and middle-income countries—a scoping review protocol

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Systematic Reviews
https://systematicreviewsjournal.biomedcentral.com/articles
[Accessed 18 Sep 2021]

 

Process evaluation of complex interventions in chronic and neglected tropical diseases in low- and middle-income countries—a scoping review protocol
The use of process evaluations is a growing area of interest in research groups working on complex interventions. This methodology tries to understand how the intervention was implemented to inform policy and practice. A recent systematic review by Liu et al. on process evaluations of complex interventions addressing non-communicable diseases found few studies in low- and middle- income countries (LMIC) because it was restricted to randomized controlled trials, primary healthcare level and non-communicable diseases. Yet, LMICs face different barriers to implement interventions in comparison to high-income countries such as limited human resources, access to health care and skills of health workers to treat chronic conditions especially at primary health care level. Therefore, understanding the challenges of interventions for non-communicable diseases and neglected tropical diseases (diseases that affect poor populations and have chronic sequelae) will be important to improve how process evaluation is designed, conducted and used in research projects in LMICs. For these reasons, in comparison to the study of Liu et al., the current study will expand the search strategy to include different study designs, languages and settings.
Authors: María Lazo-Porras, Hueiming Liu, J. Jaime Miranda, Graham Moore, Mafalda Burri, François Chappuis, Pablo Perel and David Beran
Content type: Protocol
Published on: 7 September 2021

COVID-19 Vaccine Donations—Vaccine Empathy or Vaccine Diplomacy? A Narrative Literature Review

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Vaccines
https://www.mdpi.com/journal/vaccines

 

Open Access Review
COVID-19 Vaccine Donations—Vaccine Empathy or Vaccine Diplomacy? A Narrative Literature Review
by Zhaohui Su et al.
Vaccines 2021, 9(9), 1024; https://doi.org/10.3390/vaccines9091024 – 15 Sep 2021
Abstract
Introduction: Vaccine inequality inflames the COVID-19 pandemic. Ensuring equitable immunization, vaccine empathy is needed to boost vaccine donations among capable countries. However, damaging narratives built around vaccine donations such as “vaccine diplomacy” could undermine nations’ willingness to donate their vaccines, which, in turn, […

medRxiv

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medRxiv
medRxiv is a free online archive and distribution server for complete but unpublished manuscripts (preprints) in the medical, clinical, and related health sciences. Preprints are preliminary reports of work that have not been certified by peer review. They should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information. medRxiv is for the distribution of preprints – complete but unpublished manuscripts – that describe human health research conducted, analyzed, and interpreted according to scientific principles…
https://www.medrxiv.org/content/about-medrxiv
[Accessed 18 Sep 2021]

Selected Content
A Vaccination Simulator for COVID-19: Effective and Sterilizing Immunization Cases.
Aknur Karabay, Askat Kuzdeuov, Shyryn Ospanova, Michael Lewis, Atakan Huseyin Varol
medRxiv 2021.03.28.21254468; doi: https://doi.org/10.1101/2021.03.28.21254468 Revision

The prevalence of adaptive immunity to COVID-19 and reinfection after recovery, a comprehensive systematic review and meta-analysis of 12 011 447 individuals
Tawanda Chivese, Joshua Matizanadzo, Omran Musa, George Hindy, Luis Furuya-Kanamori, Nazmul Islam, Rafal Al-Shebly, Rana Shalaby, Mohammad Habibullah, Talal Al-Marwani, Rizeq F Hourani, Ahmed D Nawaz, Mohammad Haider, Mohamed M Emara, Farhan Cyprian, Suhail A. R. Doi
medRxiv 2021.09.03.21263103; doi: https://doi.org/10.1101/2021.09.03.21263103

COVID-19 vaccine effectiveness against hospitalizations and ICU admissions in the Netherlands, April- August 2021
Brechje de Gier, Marjolein Kooijman, Jeanet Kemmeren, Nicolette de Keizer, Dave Dongelmans, Senna C.J.L. van Iersel, Jan van de Kassteele, Stijn P. Andeweg, the RIVM COVID-19 epidemiology and surveillance team, Hester E. de Melker, Susan J.M. Hahné, Mirjam J. Knol, Susan van den Hof
medRxiv 2021.09.15.21263613; doi: https://doi.org/10.1101/2021.09.15.21263613

Efficacy of two doses of COVID-19 vaccine against severe COVID-19 in those with risk conditions and residual risk to the clinically extremely vulnerable: the REACT-SCOT case-control study
Paul M McKeigue, David A McAllister, Chris Robertson, Sharon Hutchinson, Stuart McGurnaghan, Diane Stockton, Helen M Colhoun, for the PHS COVID-19 Epidemiology and Research Cell
medRxiv 2021.09.13.21262360; doi: https://doi.org/10.1101/2021.09.13.21262360

Interrogating COVID-19 Vaccine Hesitancy in the Philippines with a Nationwide Open-Access Online Survey
Alexandria Caple, Arnie O. Dimaano, Marc Martin C. Sagolili, April Anne M. Uy, Panjee Mariel G. Aguirre, Dean Lotus C. Alano, Giselle Sophia M. Camaya, Brent John A. Ciriaco, Princess Jerah S. Clavo, Dominic G. Cuyugan, Cleinne Florence Geeseler V. Fermo, Paul Jeremy C. Lanete, Ardwayne Jurel D. La Torre, Thomas Albert T. Loteyro, Raisa Mikaela Lua, Nicole Gayle R. Manansala, Raphael Willard M. Mosquito, Alexa Marie C. Octaviano, Alexandra Erika T. Orfanel, Gheyanna Merly U. Pascual, Aubrey Joy S. Sale, Sophia Lorraine S. Tendenilla, Maria Sofia Lauren R. Trinidad, Nicole Jan S. Trinidad, Daphne Louise V. Verano, Nicanor Austriaco
medRxiv 2021.09.11.21263428; doi: https://doi.org/10.1101/2021.09.11.21263428

Efficacy of vaccination against severe COVID-19 in relation to Delta variant and time since second dose: the REACT-SCOT case-control study
Paul M McKeigue, David A McAllister, Sharon J Hutchinson, Chris Robertson, Diane Stockton, Helen M Colhoun, for the PHS COVID-19 Epidemiology and Research Cell
medRxiv 2021.09.12.21263448; doi: https://doi.org/10.1101/2021.09.12.21263448

Effectiveness of Mass Vaccination in Brazil against Severe COVID-19 Cases
Daniel A.M. Villela, Tatiana Guimarães de Noronha, Leonardo S. Bastos, Antonio G. Pacheco, Oswaldo G Cruz, Luiz Max Carvalho, Claudia Torres Codeço, Marcelo Ferreira da Costa Gomes, Flávio Codeço Coelho, Laís Picinini Freitas, Raquel Martins Lana, Victor Bertollo Gomes Porto, Luiz Antônio Bastos Camacho, Claudio José Struchiner
medRxiv 2021.09.10.21263084; doi: https://doi.org/10.1101/2021.09.10.21263084

Safety, Immunogenicity, and Efficacy of COVID-19 Vaccine in Children and Adolescents: A Systematic Review
Meng Lv, Xufei Luo, Quan Shen, Ruobing Lei, Xiao Liu, Enmei Liu, Qiu Li, Yaolong Chen
medRxiv 2021.09.11.21262855; doi: https://doi.org/10.1101/2021.09.11.21262855

Predictors of real-world parents’ acceptance to vaccinate their children against the COVID-19
Petros Galanis, Irene Vraka, Olga Siskou, Olympia Konstantakopoulou, Aglaia Katsiroumpa, Ioannis Moisoglou, Daphne Kaitelidou
medRxiv 2021.09.12.21263456; doi: https://doi.org/10.1101/2021.09.12.21263456

Think Tanks et al

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Think Tanks et al
 
 
Brookings [to 18 Sep 2021]
http://www.brookings.edu/
Up Front
The game is not yet over, and vaccines still matter: Lessons from a study on Israel’s COVID-19 vaccination
Oren Heller, Yaniv Shlomo, Yung Chun, Mary Acri, and Michal Grinstein-Weiss
Monday, September 13, 2021
 
 
Center for Global Development [to 18 Sep 2021]
http://www.cgdev.org/page/press-center
Accessed 18 Sep 2021
[No new digest content identified]
 
 
Chatham House [to 18 Sep 2021]
https://www.chathamhouse.org/
Accessed 18 Sep 2021
[No new digest content identified]

 
 
CSIS
https://www.csis.org/
Accessed 18 Sep 2021
Podcast Episode
Dr. LaQuandra S. Nesbitt: “Vaccine Requirements Will Get Us Over The Finish Line”
September 17, 2021 | By J. Stephen Morrison, H. Andrew Schwartz

Blog Post
In Southeast Asia, Privatized Vaccination Schemes Gain Traction
September 16, 2021 | By Simon Tran Hudes

 
 

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
September 14, 2021 News Release
Preventable Costs of Unvaccinated COVID-19 Patients Rise Sharply in August as Hospitalizations Surge
A surge in COVID-19 hospitalizations among people who have not been vaccinated in August is adding billions of dollars in preventable costs to the nation’s health-care system, an updated KFF analysis finds. In August, the new analysis estimates that the preventable costs of treating unvaccinated patients in  hospitals total $3.7…
 
 
Rand [to 18 Sep 2021]
https://www.rand.org/pubs.html
Selected Research Reports, Featured Journal Articles
Report
Identifying Strategies to Boost COVID-19 Vaccine Acceptance in the United States
Sep 9, 2021
This report recommends strategies to help boost COVID-19 vaccine acceptance in the United States in order to reach herd immunity and end the pandemic.
Florian F. Schmitzberger, Kirstin W. Scott, Wilson Nham, Kusum Mathews, Lucy Schulson, Sydney Fouche, Nasma Berri, Alex Shehab, Ashwin Gupta, Rama A. Salhi, Neil Kamdar, Jennifer Bouey, Mahshid Abir
 
 
World Economic Forum [to 18 Sep 2021]
https://agenda.weforum.org/news/
Media
India Completes First Drone Delivery of Vaccines, Start of New Pilot Programme with World Economic Forum
News 18 Sep 2021

Majority Want to Prioritize Equitable Access to COVID-19 Vaccines Before Boosters
News 10 Sep 2021
Health experts say at least 60% of world’s population needs to be vaccinated by 2022 to get the current pandemic under control – but only 0.4% of doses have been administered in low-income countries
Majority would receive a booster shot, but think priority goes to people yet to have a full dose
Read the full report

Vaccines and Global Health: The Week in Review :: 11 September 2021

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Vaccines and Global Health: The Week in Review is a weekly digest  summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date

.– Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

– pdf version:  A pdf of the current issue is available here: 

vaccines-and-global-health_the-week-in-review_11-sep-2021Download

– blog edition: comprised of the approx. 35+ entries posted below.

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
.
– Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.

Support this knowledge-sharing service: Your financial support helps us cover our costs and to address a current shortfall in our annual operating budget. Click here to donate and thank you in advance for your contribution.

.
David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

COVID

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Milestones :: Perspectives :: Research

 

COVID

 

Editor’s Note:
As is obvious to all, the sheer volume of strategic announcements, regulatory actions, country program decisions, commentary, and, indeed, misinformation around COVID response continues at extraordinary levels. Our weekly digest strives to present a coherent and comprehensive snapshot, but cannot be exhaustive, If you recognize a missed strategic development, a new source of rigorous analysis, or an insight/commentary that would benefit our common understanding, please advise me…we will review all suggestions and consider for inclusion in a subsequent edition: david.r.curry@ge2p2global.org

We are seeking access to modelling which engages scenarios and articulates imperatives around a pandemic end-game through at least a 2025 horizon. We assess that WHO must be conducting or contracting for such modeling – or should recognize an imperative to be doing so in its global health governance role. If we have missed such modeling in progress, we would be delighted to be advised of it and will include it in our coverage.

WHO Director-General’s opening remarks at the media briefing on COVID-19 – 8 September 2021

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Milestones :: Perspectives :: Research

 

WHO Director-General’s opening remarks at the media briefing on COVID-19 – 8 September 2021
8 September 2021 Speech [Editor’s text bolding]
:: Today, the Democratic Republic of the Congo declared an outbreak of meningitis in the north-eastern Tshopo Province, with 261 suspected cases and 129 deaths reported. Health authorities have deployed an initial emergency team, and WHO is supporting the response.

:: More than 50 thousand people have died with COVID-19 every week since October last year, and for the past month, deaths have remained at almost 70 thousand a week. We have the solutions to stop transmission and save lives. The inequitable distribution of life-saving tools including diagnostics, oxygen, PPE and vaccines is driving a two-track pandemic.

:: Globally, 5.5 billion vaccine doses have now been administered, but 80 percent have been administered in high- and upper-middle income countries. High-income countries have promised to donate more than 1 billion doses, but less than 15 percent of those doses have materialised. Manufacturers have promised to prioritize COVAX and low-income countries. We don’t want any more promises. We just want the vaccines.

:: A month ago, I called for a global moratorium on booster doses at least until the end of September, to prioritise vaccinating the most at-risk people around the world who are yet to receive their first dose. There has been little change in the global situation since then, so today I am calling for an extension of the moratorium until at least the end of the year, to enable every country to vaccinate at least 40 percent of its population.  

 

:: As the world’s largest producers, consumers and donors of vaccines, the world’s 20 leading economies hold the key to vaccine equity and ending the pandemic. Now is the time for true leadership, not empty promises.

COVAX – Vaccines Supply

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Milestones :: Perspectives :: Research

 

COVAX – Vaccines Supply
“The evolving supply landscape has led to a reduction of ~25% in anticipated volumes available for supply in 2021 through COVAX. Interventions from manufacturers could improve these deliveries.”

Joint COVAX statement on Supply Forecast for 2021 and early 2022
CEPI, Gavi, UNICEF, WHO [Editor’s text bolding]
Geneva/New York/Oslo, 8 September 2021 – Twelve months ago, the world came together to support COVAX, a multilateral initiative aimed at guaranteeing global access to life-saving COVID-19 vaccines.

With the support of the international community, COVAX immediately began securing financing, entering into negotiations with vaccine developers and manufacturers and addressing the host of technical and operational challenges associated with rolling out the largest and most complex vaccination programme in history.

 

COVAX has already achieved significant progress: more than US$10 billion has been raised; legally-binding commitments for up to 4.5 billion doses of vaccine; 240 million doses have been delivered to 139 countries in just six months.

Yet the global picture of access to COVID-19 vaccines is unacceptable. Only 20% of people in low- and lower-middle-income countries have received a first dose of vaccine compared to 80% in high- and upper-middle income countries.

In the critical months during which COVAX was created, signed on participants, pooled demand, and raised enough money to make advance purchases of vaccines, much of the early global supply had already been bought by wealthy nations. Today, COVAX’s ability to protect the most vulnerable people in the world continues to be hampered by export bans, the prioritisation of bilateral deals by manufacturers and countries, ongoing challenges in scaling up production by some key producers, and delays in filing for regulatory approval.

According to its latest Supply Forecast, COVAX expects to have access to 1.425 billion doses of vaccine in 2021, in the most likely scenario and in the absence of urgent action by producers and high-coverage countries to prioritize COVAX. Of these doses, approximately 1.2 billion will be available for the lower income economies participating in the COVAX Advance Market Commitment (AMC). This is enough to protect 20% of the population, or 40% of all adults, in all 92 AMC economies with the exception of India. Over 200 million doses will be allocated to self-financing participants. The key COVAX milestone of two billion doses released for delivery is now expected to be reached in the first quarter of 2022.

In addition to working closely with participating governments to ensure the conditions are in place on the ground to facilitate successful rollout of vaccines, COVAX and its partners call on donors and manufacturers to recommit their support, and prevent further delays to equitable access by ensuring the following:

:: Manufacturers deliver to COVAX in accordance with firm commitments and provide transparency on timelines for availability to COVAX to allow countries to plan in advance.

:: Where countries are ahead of COVAX in manufacturer queues, and already have achieved high coverage, to give up their place in the queue to COVAX so that its participants can access the doses already secured via supply contracts and deliver vaccines to where they are needed most.

:: Expand, accelerate, and systematize dose donations from countries that are already well advanced in their vaccination programmes. This includes ensuring doses are available in larger and more predictable volumes, with longer shelf lives – reducing the burden on countries trying to prepare for deliveries.

As the COVID-19 pandemic continues to claim lives, destroy livelihoods and stunt economic recovery, we continue to emphasise that no one is safe until everyone is safe. There is only one way to end the pandemic and prevent the emergence of new and stubborn variants and that is by working together.

 

::::::

COVAX Global Supply Forecast
September 8, 2021
[Excerpts; Text bolding from original]
…While Q4 will see a dramatic increase in deliveries, this latest forecast reflects a reduction in the number of doses that COVAX expected to receive in 2021. The three major reasons for this are:
:: Export restrictions, particularly with respect to uncertainty around the resumption of exports from the Serum Institute of India (SII), a key COVAX supplier.
:: Scale-up challenges at manufacturing sites that supply COVAX. These issues particularly affect supply of the Johnson & Johnson (J&J) and AstraZeneca (AZ) vaccines.
:: The timing and likelihood of filing and regulatory approval for candidates produced by Novavax, SII-Novavax, and Clover, with WHO Emergency Use Listing (EUL) or approval by a Stringent Regulatory Authority (SRA) required for supply to COVAX participants

COVAX is making strenuous efforts to address and mitigate these risks. In addition to ongoing dialogue with the Government of India, we are calling on donors and manufacturers to:
:: Make supply schedules transparent, so that it is not possible for manufacturers to prioritize
bilateral customers over COVAX.
:: To give up their place in the queue to COVAX where countries are ahead of COVAX and have
enough doses to meet domestic needs
:: Expand, accelerate, and systematize dose donations.

In addition to the efforts being made to bring forward supply, COVAX partners continue to work hard
with recipient health ministries to ensure they are able of absorbing much larger deliveries in the
fourth quarter. Ensuring demand is capable of meeting increased supply will be an essential
objective for COVAX going forward.

This supply forecast will continue to evolve. The forecast will continue to be regularly updated
based on the best available information from manufacturers and subsequent analysis by Gavi and
UNICEF. For example, should India’s export ban be lifted, and J&J returns to its earlier commitments
for 2021 supply, major additional doses could become available to COVAX in 2021…

Selected Slide:

Momentum of COVID-19 vaccine manufacturing scale up sufficient for step change in distribution

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Milestones :: Perspectives :: Research

 

Momentum of COVID-19 vaccine manufacturing scale up sufficient for step change in distribution
IFPMA Media Release, Published 07 September 2021
[Editor’s text bolding]
:: This month COVID-19 vaccine manufacturing output will pass the 7.5 billion dose mark. Vaccine manufacturers worldwide are now producing 1.5 billion doses per month and this is expected to continue growing. 12 billion vaccines will be produced by the end of 2021 and if there are no major bottlenecks, by June 2022 total vaccine production is estimated to reach over 24 billion by which time vaccine supplies will most likely outstrip global demand.

:: The biopharmaceutical industry continues to call for dose sharing and renew its commitment to work with governments to support their efforts. From now on, G7 countries have sufficient stocks of doses to vaccinate adults, teenagers and roll out boosters programmes to protect the most at-risk groups as well as substantially increase the number of doses available to low- and lower-middle-income countries. Political leadership is critical to enable dose deliveries as quickly as possible.

:: Reducing the toll of the pandemic on lives and livelihoods requires equitable access to vaccines and country readiness for vaccination. Therapeutics are integral to COVID-19 mitigation strategies, but more testing and demand data is needed to ensure these can be rolled out equitably.

Geneva, 7 September 2021: Innovative biopharmaceutical company trade body announced that COVID-19 vaccines dose production will reach 7.5 billion at the end of September, at a rate of nearly 1.5 billion doses each month. The successful vaccine manufacturing scale up has been achieved thanks to a steady increase in production, supply chain, and voluntary tech transfer agreements with partners across the world. By January 2022, there will be sufficient vaccines produced for every adult on every continent. Modelling by Airfinity (report here) indicates that even if vaccine advisory committees and governments in G7 countries vaccinate teenagers and adults and decide to give boosters to at-risk populations, there would still be over 1.2 billion doses available for redistribution in 2021 alone. This means that each month for the foreseeable year, over 200 million doses would be, with effective planning, available for low- and lower-middle-income countries.

The historic COVID-19 manufacturing scale up should now urgently shift attention to delivering vaccine equity including dose sharing. In May 2021, the innovative biopharmaceutical industry publicly committed to expend every effort to make additional uncommitted COVID-19 doses available to low- and lower-middle-income countries (LMIC) and to support governments that have significant domestic supplies of COVID-19 vaccine doses to share a meaningful proportion of their doses with LMICs in a responsible and timely way through COVAX or other efficient established mechanisms (link here).

The new Airfinity data show that equitable redistribution of doses can be stepped up. Thanks to the steady vaccine manufacturing output, projections show it is possible to vaccinate the whole adult population of the world by June 2022. But this requires governments to strategically release doses so that vaccines leave the production lines and reach the people who need them most, from healthcare workers to vulnerable populations. Such vaccine deployment requires urgent political leadership and coordinated action to remove delivery and administration bottlenecks in many environments, especially as mRNA vaccines might make up to 40% of the additional doses available. Here again, industry stands by its commitments of May 2021, to support country readiness, and partner with governments on COVID-19 vaccine deployment, particularly in LMICs, to ensure that they are ready and able to deploy available doses within their shelf life (link here)…

 

::::::

COVID-19 vaccine stock forecast for 2021 and 2022- Summary Version
airfinity 4 September 2021
PDF available upon registration at link above.
Selected slide/blow-up.

Xi: China to donate another 100m doses of COVID vaccines

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Milestones :: Perspectives :: Research

 

Xi: China to donate another 100m doses of COVID vaccines
chinadaily.com.cn|Updated: 2021-09-10
China will donate 100 million more doses of COVID-19 vaccines to developing countries within this year on top of a donation of $100 million to COVAX, President Xi Jinping said on Sept 9.
Xi made the remarks when addressing the 13th BRICS summit via video link in Beijing. BRICS refers to the emerging market economies Brazil, Russia, India, China and South Africa.
China will strive to provide a total of 2 billion doses of COVID-19 vaccines to the world by the end of this year, said Xi, noting that China, to date, has provided more than 1 billion doses of finished and bulk vaccines to over 100 countries and international organizations.

The G20 Must Recommit to COVAX

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Milestones :: Perspectives :: Research

 

The G20 Must Recommit to COVAX
Project Syndicate, Sep 3, 2021 Seth Berkley, CEO Gavi Alliance
Additional G20 support can make the COVID-19 Vaccine Global Access facility a success. Failure to achieve equitable access would mean more lives lost, broken health-care systems, even deadlier and more transmissible variants, and a pandemic with no end in sight…
…By recommitting to COVAX, G20 leaders will recommit to a multilateral solution that builds on the astounding scientific progress of the past year. Based on COVAX’s latest forthcoming supply forecast, when topped up with doses through bilateral deals, equitable COVID-19 vaccine access can protect up to 60% of the adult population in 91 lower-income countries. This would represent a huge step toward the WHO target of 70%, which is needed to suppress the coronavirus everywhere, and COVAX represents the best opportunity to achieve it.
Failure would mean more lives lost, broken health-care systems, even deadlier and more transmissible variants, and a pandemic with no end in sight. The G20 must not allow that to be an option.

 

::::::

Editor’s Note:
We highlight selected text from the G20 Health Minister’s Final Declaration as below. The G20 meeting involving heads of state and government will be convened in Rome on October 30-31, 2021 and will address COVID response.

G20 Health Ministers’ Meeting – Rome 5-6 Sep 2021
…During the two days of work, participants focused on multiple issues related to health. In particular, three sessions were dedicated to the impact of Covid-19 on the sustainable development goals (SDG) of the 2030 Agenda, to what should be done in order to prevent, be better prepared and respond to future pandemics and the tools which allow to effectively counter the pandemic…

Final Declaration [5,945 words]: https://www.g20.org/wp-content/uploads/2021/09/G20_Italia_2021_Health_Declaration_final_05092021_OFFICIAL.pdf
[Selected excerpts; Editors text bolding]

7. As our Leaders committed to in Riyadh, and reinforced at the Global Health Summit in Rome, we will work towards enhancing timely, equitable and global access to safe, affordable and effective COVID-19 vaccines, therapeutics and diagnostics (VTDs). In line with the WHO, we support the goal to vaccinate at least 40% by the end of 2021 of the global population… We need to also share more doses to meet the immediate need for safe, effective and quality and affordable vaccines building upon the commitments made at the COVAX AMC Summit…

17. We commit to improving rapid and transparent research, data, information and material access and sharing, in line with applicable laws and regulations at the national and international levels, necessary to prevent, detect, and respond to future potential health emergencies, and collectively resolve to strengthen research initiatives to better understand the links between human, animal (both domestic and wild) and environmental health, to enhance decision making based on solid scientific evidence…

ACCESSIBLE VACCINES, THERAPEUTICS AND DIAGNOSTICS
…28. We encourage a collaborative effort to develop common global strategies to support research, development, and equitable distribution of vaccines, therapeutics – including, but not limited to, medical oxygen – and diagnostics, taking into consideration the ongoing WHO Member State process to examine strengthening health emergencies preparedness and response…High quality, adequately sized clinical trials are the primary way to generate actionable evidence, informing which vaccines and therapeutics are safe and effective. We will support science to shorten the cycle for the development of safe and effective vaccines, treatments and tests from 300 to 100 days…

30. …We reaffirm our Leaders’ support at the Global Health Summit for the global sharing of safe, effective, quality and affordable vaccine doses including working with the ACT-A vaccines pillar (COVAX) co-lead by CEPI, Gavi and WHO… We welcome the outcomes of the COVAX Advanced Market Commitment (AMC) Summit co-hosted by Japan and Gavi, which include mobilizing and exceeding the targeted resources to ensure the 1.8 billion doses needed to cover nearly 30% of the population of AMC eligible economies, and dose-sharing commitments, and urge additional support for vaccine production, necessary supplies, other delivery and distribution needs, and vaccination support. We support the establishment of the COVAX Humanitarian Buffer and the commitment by Gavi/COVAX to allocate up to 5% of the doses for this purpose. We recognize the need to complement vaccine supply with financing for vaccine absorption and delivery, and surge capacity of resources to deploy these vaccines…

A Call for a Global Summit to End the COVID-19 Pandemic

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Milestones :: Perspectives :: Research

 

Global COVID Summit – Proposed for UN General Assembly, Sep 2021

A Call for a Global Summit to End the COVID-19 Pandemic
SEPTEMBER 1, 2021
Dear World Leaders Attending the 2021 UN General Assembly:
The world is at a perilous and urgent moment in the COVID-19 pandemic. The Delta variant has spread
rapidly to more than 130 countries, demonstrating that we are fighting a virus that doesn’t respect
borders and advances rapidly across continents.

The best way to prevent further catastrophe is to dramatically decrease worldwide cases and slow
transmission of the virus through widespread global vaccination, combined with other public health
measures. However, inequitable access to high-quality vaccines and capacity to administer them is prolonging the pandemic and destabilizing economies and societies around the world.

Therefore, we call on world leaders to convene a global summit during this year’s United Nations General Assembly and commit to actions to make 7 billion doses of high-quality vaccines available before the end of 2021 and an additional 7 billion doses by mid-2022; ensure that every country is ready to implement equitable vaccination programs at scale by the end of this year; and vaccinate 70 percent of the world’s population by mid-2022. People everywhere should also have equitable access to tests, therapies, and other proven interventions so lives can be saved using all COVID-19 tools.

A global pandemic needs a global plan of attack. The summit should secure the commitments and actions needed to close the vaccine supply, financing and capacity gaps. Very soon there will be enough supply of high-quality vaccines to assure that all countries can meet the needs of their own citizens and also engage in a global effort to vaccinate everyone. Urgent actions must be taken to increase countries’ distribution and delivery capabilities, which are poised to become the key constraint in the race between vaccines and variants. That is why we need a comprehensive response to the current crisis, which will also strengthen health systems and preparedness for the next pandemic…

“Endorsed by a broad coalition of leaders and organizations” [listing here.]

 

::::::

Biden to Call for Vaccine Conference at UN Amid Shot Scarcity
Politics
By Josh Wingrove and David Wainer
Bloomberg, September 8, 2021, 7:07 PM EDT
:: With virus spreading, Covax program cuts its supply forecast
:: Advocates say U.S. pledge of 600 million doses is not enough
President Joe Biden plans to call for a meeting on global vaccine supply to be held at the United Nations General Assembly later this month, as wealthy nations face pressure to do more to bolster inoculations for developing countries, according to people familiar with the matter.
Biden intends to host a session during the UN meetings, though the scope and the attendees aren’t yet clear. While the U.S. has been reaching out to other countries about participating in the session, it hasn’t finalized its plans, the people said…

 

::::::

Editor’s Note:
U.S. President Biden’s announcement of the Path Out of the Pandemic action plan on 9 September did not include the anticipated announcement of a global COVID summit to be convened during the upcoming UN General Assembly (UNGA 76) – 14-30 September 2021 in New York.

The closing text of the plan ̶ which notably included a number of national-level COVID vaccination mandates affecting employees of the U.S. federal government and private commercial organizations ̶ noted only: “… In the weeks ahead, the President will announce additional steps to build on the progress the Administration has made to combat this pandemic globally…”

IsDB to Work with Member Countries in Dealing with Vaccine Divide

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IsDB to Work with Member Countries in Dealing with Vaccine Divide
Tashkent, Uzbekistan, 02 September 2021 – The Islamic Development Bank (IsDB) will work closely with the 57 member countries of the Bank to deal swiftly with the emerging vaccine divide. The President of Islamic Development Bank, H.E. Dr. Muhammad Al Jasser, stated this in a historic speech delivered in Tashkent, the capital of Uzbekistan, during the opening ceremony of the 2021 Annual Meetings of IsDB Group.
Dr. Al Jasser delivered the speech in the presence of H.E. President Shavkat Mirziyoyev of Uzbekistan and the 57 ministers of finance, economy, planning and international development from IsDB member countries who serve in the bank’s Board of Governors. He assured the governors that despite the challenges of COVID-19, the financial position of IsDB remains stable with the Bank maintaining its AAA rating of intact for over a decade.
The IsDB President stated that although IsDB member countries account for around 25% of the world population, only 10% (9.7%) of all 5.2 billion doses administered worldwide were in our member countries. Thus, a ‘Vaccine Divide’ has emerged.
“Failure to swiftly deal with this emerging phenomenon will impede recovery and slow economic growth, further widening gaps and worsening inequalities,” Dr. Al Jasser elaborated.
In its effort to support the member countries, IsDB has committed US$ 4.5 billion to help member countries contain, mitigate, and recover from the impact of COVID-19 by adopting a 3-R approach (Respond, Restore, Restart)…

COVID-19 Research – Recommendations & Considerations for GloPID-R, 2021-2023

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COVID-19 Research – Recommendations & Considerations for GloPID-R, 2021-2023
GloPID-R Scientific Advisory Group – June 18, 2021:: 62 pages
PDF: https://www.glopid-r.org/wp-content/uploads/2021/09/glopid-r-sag-report.pdf
EXECUTIVE SUMMARY
The COVID-19 pandemic has posed the challenge of a century and has catapulted the critical importance of emerging diseases research onto the front page. Building from earlier research investments, and with over $3.8 billion in new research funding invested in response to the events of the pandemic, the importance of preparedness research needs no further justification1.

There have been some key successes in the pandemic-related research: the rapid coordination of research needs through the WHO R&D Blueprint mechanism and the ensuing funding calls offered through the research funders coalition Global Research Collaboration for Infectious Disease Preparedness (GloPID-R), the Coalition for Epidemic Preparedness Innovations (CEPI), and others have greatly enhanced our knowledge of the new pathogen and its impact. Essential knowledge gaps were filled through a range of basic, translational, and clinical research studies, and the findings of these studies have found their way into the evidence-based guidance that WHO and other public health and clinical partners developed.

New mechanisms of pathogenesis were identified that helped inform the choice of potential therapeutic approaches, which were then trialled in clinical trial networks, allowing the rapid evaluation of their utility. Against all expectations, within a year of the release of the first genomic information by Chinese scientists, the first clinical trials of vaccines were completed, showing the first promise of a way out.

Nonetheless, the pandemic is far from over, and is stretching the capacity of the world to deal with this health crisis. Challenges such as the emergence of new variants, vaccine acceptance, and the glaring global inequity in access have arisen as major concerns.

As the world faces the uncertainty of the second year of the COVID-19 pandemic, the leadership of the GloPID-R asked their Scientific Advisory Group2 (SAG) to recommend an approach to research funding for COVID-19 over the coming 12–18 months. For this purpose, the SAG members reviewed existing research agendas and documents, and applied their expertise to undertake a scenario-planning approach to produce possible future scenarios for the COVID-19 and related research landscape. These scenarios were used to navigate and help frame the uncertainty around COVID-19 and infectious diseases, and to provide research recommendations.

Marlène Schiappa annonce la naturalisation de plus de 12 000 travailleurs étrangers en première ligne pendant la crise sanitaire

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Marlène Schiappa annonce la naturalisation de plus de 12 000 travailleurs étrangers en première ligne pendant la crise sanitaire
Ministre de L’Interieur
Publié le 09/09/2021

A l’occasion de la cérémonie de naturalisation organisée au Panthéon ce jeudi 9 septembre 2021, Marlène Schiappa, ministre déléguée auprès du ministre de l’Intérieur, chargée de la Citoyenneté, dresse le bilan du dispositif exceptionnel d’acquisition de la nationalité française des ressortissants étrangers mobilisés pendant la crise sanitaire, qu’elle a créé le 14 septembre dernier.

Un an après son lancement, 16 381 dossiers ont été déposés en préfecture sur l’ensemble du territoire français et 12 012 étrangers sont devenus Français. C’est le résultat d’un examen bienveillant de ces dossiers, qui s’est traduit, par exemple, par la réduction de la durée de séjour régulier sur le territoire national à 2 ans, au lieu de 5 dans le droit commun des naturalisations.

Professionnels de santé, agents de sécurité ou d’entretien, garde d’enfants, caissiers, aide à domicile, éboueurs… La République s’honore d’accueillir en son sein ces nouveaux Français qui ont montré tant de détermination et de dévouement à servir leurs compatriotes. Plusieurs d’entre eux se sont vu convier Place Beauvau à la rentrée.

« Ces travailleurs de la première ligne ont répondu présents pour la nation. C’est normal que la nation fasse un pas vers eux. Je souhaite bienvenue dans la nationalité française à nos nouveaux compatriotes et leur dis merci au nom de la République : le pays a tenu bon aussi grâce à eux ! » déclare la ministre Marlène Schiappa.

 

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France grants citizenship to 12,000 Covid frontline workers
Fast-track scheme is aimed at those whose jobs put them at risk in pandemic
The Guardian, 9 Sep 2021
France has granted citizenship to more than 12,000 frontline workers whose jobs put them at risk during the Covid pandemic under a special fast-track scheme.
As well as speeding up the application process, which normally takes up to two years, the government also cut the residency requirement from five years to two.
“Frontline workers responded to the call of the nation, so it is right that the nation takes a step towards them,” said the citizenship minister, Marlène Schiappa. “The country pulled through thanks to them.
“I welcome our new compatriots to French nationality and thank them in the name of the republic. The country also thanks them.”…

INCB, UNODC and WHO Joint Statement on Access to Controlled Medicines in Emergencies

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INCB, UNODC and WHO Joint Statement on Access to Controlled Medicines in Emergencies
8 September 2021 Joint News Release
Access to controlled medicines in humanitarian emergencies remains constrained

Recognizing World Humanitarian Day 2021, the International Narcotics Control Board (INCB), the United Nations Office on Drugs and Crime (UNODC) and the World Health Organization (WHO) once again call on governments to facilitate access to medicines containing controlled substances in emergency settings, including during pandemics and the increasing number of climate-related disasters.

The theme of World Humanitarian Day 2021 acknowledged the impact of climate-related emergencies. Over 7,348 disasters have been reporting in the last two decades of which 40% are now estimated to be climate-related according to United Nations reports. The impact of their increasing number combined with the persistent COVID-19 pandemic creates a complex landscape for ensuring access to controlled medicines in emergencies.

A year after an  earlier joint statement, unprecedented trade restrictions, shortages of medicines, surges in infections and new variants of SARS-CoV-2 compound the problems related to maintaining supply of controlled medicines, according to WHO and the World Trade Organization.

 

The problem of access to controlled medicines in emergencies
There is an increase in demand for controlled medicines in emergency responses. Since the beginning of the COVID-19 pandemic, WHO has identified over 20 medicines with global-level shortages, including four that contain controlled substances that are used in intensive care units for treatment of severe cases of COVID-19. Internationally controlled medicines such as morphine, diazepam and midazolam listed as WHO essential medicines, are vital for the management of pain, palliative care, surgical care and anesthesia, and treatment of drug-use disorders, mental health and neurological conditions.

Shortages impact countries of all income levels. Low- and middle-income countries (LMIC) are often disproportionately impacted by shortages–partly related to their relative purchasing power in international medicines markets and partly because specialized systems to manage controlled medicines do not always accommodate sufficient exceptions for emergencies.

 

Urgent action is needed to ensure that national systems improve access to controlled medicines for people affected by emergencies, including pandemics, and climate-related disasters.

Action by governments and the international community
WHO guidelines on controlled medicines in emergencies outline simplified control measures for the cross-border trade of controlled medicines during humanitarian emergencies. They have been adapted into operational terms in the Inter-Agency Emergency Health Kit guidance. These guidelines and others have been in place for many years but are not consistently or effectively used by all countries.

In the current global landscape, it is of paramount importance that relevant authorities in exporting and importing countries exercise and apply the flexibilities described in these guidelines in several key areas, such as:
:: Amendments, waivers or new provisions that allow for greater flexibility in the use of control measures on controlled medicines during emergencies;
:: Enhanced partnerships, including reliance on relevant humanitarian agencies to carry out certain activities on behalf of governments;
:: Flexibilities that would ensure safe, timely and appropriate use of controlled medicines in emergencies, including provisional and long-term solutions…

COVID-19 Data Explorer: Global Humanitarian Operations

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COVID Vaccines – OCHA:: HDX

COVID-19 Data Explorer: Global Humanitarian Operations
COVID-19 Vaccine Roll-out
Sep 11, 2021 | COVAX (WHO,GAVI,CEPI), UNDESA, Press Reports | DATA
Global COVID-19 Figures: 223M total confirmed cases; 4.6M total confirmed deaths
Global vaccines administered: 5.64B
Number of Countries: 29 [29 week ago]
COVAX Allocations Round 4-6 (Number of Doses): 120M [120M week ago]
COVAX Delivered (Number of Doses): 85M [74M week ago]
Other Delivered (Number of Doses): 110M [110M week ago]
Total Delivered (Number of Doses): 200M [180M week ago]
Total Administered (Number of Doses): 170M [160M week ago]

 

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Multilateral Leaders Task Force on COVID-19 [IMF, World Bank Group, WHO, WTO]
A joint initiative from the International Monetary Fund, World Bank Group, World Health Organization, and World Trade Organization to accelerate access to COVID-19 vaccines, therapeutics and diagnostics by leveraging multilateral finance and trade solutions, particularly in low- and middle-income countries.
Website accessed 11 Sep 2021: https://data.covid19taskforce.com/data The global view below is complemented by country-specific dashboards here.

World Bank Vaccine Operations Portal

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World Bank Vaccine Operations Portal
https://www.worldbank.org/en/who-we-are/news/coronavirus-covid19/world-bank-support-for-country-access-to-covid-19-vaccines
As of July 29, 2021, the World Bank approved operations to support vaccine rollout in 54 countries amounting to $4.6 billion. See the latest project financing, project documents and procurement information in the list below:

Countries receiving World Bank support for vaccines
As of August 31, 2021, the World Bank approved operations to support vaccine rollout in 54 countries amounting to $4.6 billion. See the latest project financing, project documents and procurement information in this list. More information will be shared here as it becomes available.

Coronavirus [COVID-19] – WHOPublic Health Emergency of International Concern (PHEIC)

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::::::

 

Coronavirus [COVID-19] – WHO
Public Health Emergency of International Concern (PHEIC)
https://www.who.int/emergencies/diseases/novel-coronavirus-2019

 

Weekly Epidemiological and Operational updates
Last update: 10 Sep 2021
Confirmed cases :: 223 022 538 [218 946 836 week ago]
Confirmed deaths :: 4 602 882 [4 539 723 week ago]
Vaccine doses administered: 5 352 927 296 [5 289 724 918 week ago]

 

8 September 2021
Speech
WHO Director-General’s briefing to the African Union Ambassadors

8 September 2021
Speech
WHO Director-General’s opening remarks at the media briefing on COVID-19 – 8 September 2021
[See Milestones above for detail]

6 September 2021
Speech
WHO Director-General’s intervention at the G20 Health Ministers Meeting: Session 2

6 September 2021
Speech
WHO Director-General’s intervention at the G20 Health Ministers’ Meeting

6 September 2021
Speech
WHO Director-General’s address at the Regional Committee of the WHO South-East Asia Region

6 September 2021
Speech
WHO Director-General’s opening remarks at the 74th Session of the WHO Regional Committee for South-East Asia

5 September 2021
Speech
WHO Director-General’s opening remarks at G20 Health Ministers Meeting – 5 September 2021

 

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WHO strengthens COVID-19 response by improving regional vaccine production, distributing vaccines to the vulnerable and delivers essential supplies
7 September 2021

 

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Weekly operational update on COVID-19 – 30 August 2021
Overview
In this edition of the COVID-19 Weekly Operational Update, highlights of country-level actions and WHO support to countries include:
– GeneXpert machine donated to Belize’s Central Medical Laboratory
Supporting quality management implementation, coordination and costing as part of the COVID-19 laboratory response in Kyrgyzstan
– 15 000 kg of medical supplies arrive in Fiji to support the response to a surge in COVID-19 cases
– Extending COVID-19 vaccination to Rohingya refugees in Cox’s Bazar camps in Bangladesh
Responding to COVID-19 in Jordan: The Innovative Use of Online Platforms
– The Elsje Finck-Sanichar College COVAB in Suriname embraces OpenWHO and online learning during COVID-19 pandemic
– Progress on a subset of indicators from the SPRP 2021 Monitoring and Evaluation Framework
Updates on WHO’s financing to support countries in SPRP 2021 implementation and provision of critical supplies.

Weekly epidemiological update on COVID-19 – 7 September 2021
Overview
The global incidence of COVID-19 cases has remained stable over the month with over 4.4 million new cases reported this week (30 August-5 September). During this period, all regions reported either a decline (Regions of Africa, South-East Asia, and the Eastern Mediterranean) or a similar trend (Regions of Europe and the Western Pacific) in new weekly cases, except for the Region of the Americas which reported a 19% increase as compared to previous week. The number of deaths reported globally this week also remained similar to the previous week, with just under 68 000 new deaths reported. The incidence of new deaths declined in all regions apart from the Region of the Americas and Europe where deaths increased by 17% and 20% respectively.

The cumulative number of cases reported globally is now just over 220 million and the cumulative number of deaths is over 4.5 million.

In this edition, one special focus update is provided:
:: A detailed update on the phenotypic characteristics (transmissibility, disease severity, risk of reinfection, and impacts on diagnostics and vaccine performance) of SARS-CoV-2 Variants of Concern (VOCs) Alpha, Beta, Gamma and Delta. It also includes updates on the geographic distribution of VOCs.

Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 19 August 2021
For 22 vaccine candidates, presents Manufacturer, Name of Vaccine, NRA of Record, Platform, EOI Accepted Status, Pre-submission Meeting Held Status, Dossier Accepted for Review, Status of Assessment; Anticipated/Completed Decision Date
[No updates since 19 Aug 2021]
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COVID Vaccine Developer/Manufacturer Announcements

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COVID Vaccine Developer/Manufacturer Announcements
[relevant press releases/announcement from organizations from WHO EUL/PQ listing above]

 

AstraZeneca
Press Releases
International Respiratory Coalition launches to transform post-pandemic respiratory healthcare
09 September 2021
COVID-19 highlights urgent need for national respiratory strategies to drive improvements in patient outcomes and healthcare system resilience

BioCubaFarma – Cuba
Últimas Noticias – [Website not responding at inquiry; receiving 403-Forbidden]

 

CanSinoBIO
News – [Website not responding at inquiry]

Clover Biopharmaceuticals – China
News
Sep 10,2021
Clover Biopharmaceuticals Receives Pharmaceutical Manufacturing Permit from Zhejiang Medical Products Administration to Produce COVID-19 Vaccine
CHENGDU, China, September 9, 2021—Clover Biopharmaceuticals, Ltd. (Clover), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced that its wholly-owned subsidiary, Zhejiang Clover Biopharmaceutical, Inc., received a Pharmaceutical Manufacturing Permit from the Zhejiang Medical Products Administration for the production of Clover’s protein-based COVID-19 vaccine candidate at its facility in Changxing, Zhejiang province, China (Changxing facility)…

 

Curevac [Bayer Ag – Germany]
News – No new digest announcements identified

 

Gamaleya National Center
Latest News and Events – No new digest announcements identified [See Russia/RFID below]

IMBCAMS, China
Home – No new digest announcements identified

 

Janssen/JNJ
Press Releases – No new digest announcements identified

 

Moderna
Press Releases
September 9, 2021
Moderna Announces Significant Advances Across Industry-Leading mRNA Portfolio at 2021 R&D Day
:: New development candidate for combination respiratory COVID-19 booster + seasonal flu booster vaccine
:: New pediatric combination development candidate for RSV + hMPV vaccine
:: Interim Phase 1 data from RSV vaccine candidate in older adults significantly boosted neutralizing antibody titers above baseline
:: New infectious disease therapeutic vaccine candidate, to complement Epstein-Barr virus prophylactic vaccine
:: Phase 2 randomized, placebo-controlled study of personalized cancer vaccine fully enrolled; primary endpoint is recurrence free survival at 12 months
:: Company continues to scale with 37 programs in development, including 22 in ongoing clinical studies

September 8, 2021
Resilience to Manufacture mRNA for Moderna’s COVID-19 Vaccine

 

Novavax
Press Releases
Novavax Statement on Takeda Agreement to Provide 150 Million Doses of NVX-CoV2373 to the Government of Japan
Sep 10, 2021

Novavax Initiates Phase 1/2 Clinical Trial of Combination Vaccine for COVID-19 and Seasonal Influenza
Sep 10, 2021
— First participants enrolled in Phase 1 clinical trial of combination NanoFlu™/NVX-CoV2373 vaccine with Matrix-M™ adjuvant
— Phase 1/2 study will evaluate immunogenicity and safety

 

Pfizer
Recent Press Releases – No new digest announcements identified

 

Sanofi Pasteur
Press Releases – No new digest announcements identified

 

Serum Institute of India
NEWS & ANNOUNCEMENTS – No new digest announcements identified

 

Sinopharm/WIBPBIBP
News – [Website not responding at inquiry]

 

Sinovac
Press Releases
New Research on SINOVAC’s COVID-19 Vaccine Shows Third Dose More Effective Against COVID-19, Including the Delta Variant
2021/09/09
Study findings demonstrate that a booster dose of inactivated COVID-19 vaccine produces a highly sifted, humoral immune response via a sustained evolution of antibodies, able to effectively neutralize SARS-CoV-2 variants of concern.

SINOVAC Announces COVID-19 Vaccine Approved for Emergency Use in Chile for Children and Adolescents
BEIJING, China, Sep 9, 2021 – SINOVAC Biotech Ltd. (“SINOVAC” or the “Company”) (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that CoronaVac®, an innovative, inactivated coronavirus vaccine developed by SINOVAC Life Sciences Co., Ltd. (“SINOVAC”), a subsidiary of the Company, received approval from the Public Health Institute of Chile (“ISP”) for emergency use for children and adolescents aged between 6 and 17…

 

Vector State Research Centre of Viralogy and Biotechnology
Home – No new digest announcements identified

Zhifei Longcom, China
[Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.]
[No website identified]

 

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GSK
Press releases for media – No new digest announcements identified

 

SK Biosciences
Press releases – No new digest announcements identified

Duke – Launch and Scale Speedometer

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Duke – Launch and Scale Speedometer

The Race for Global COVID-19 Vaccine Equity
A flurry of nearly 200 COVID-19 vaccine candidates are moving forward through the development and clinical trials processes at unprecedented speed; more than ten candidates are already in Phase 3 large-scale trials and several have received emergency or limited authorization. Our team has aggregated and analyzed publicly available data to track the flow of procurement and manufacturing and better understand global equity challenges. We developed a data framework of relevant variables and conducted desk research of publicly available information to identify COVID vaccine candidates and status, deals and ongoing negotiations for procurement and manufacturing, COVID burden by country, and allocation and distribution plans. We have also conducted interviews with public officials in key countries to better understand the context and challenges facing vaccine allocation and distribution
[accessed 24 July 2021]
See our COVID Vaccine Purchases research
See our COVID Vaccine Manufacturing research
See our COVID Vaccine Donations & Exports research

Global Dashboard on COVID-19 Vaccine Equity

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Global Dashboard on COVID-19 Vaccine Equity
The Dashboard is a joint initiative of UNDP, WHO and the University of Oxford with cooperation across the UN system, anchored in the SDG 3 Global Action Plan for Healthy Lives and Well-being for All.

Dashboard on Vaccine Equity [accessed 11 Sep 2021]: https://data.undp.org/vaccine-equity/
See also visualization on Vaccine Access and Vaccine Affordability

U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

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U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

 

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Vaccines and Related Biological Products Advisory Committee- FDA
:: Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement
Agenda
…The committee will meet in open session to discuss the Pfizer-BioNTech supplemental Biologics License Application for COMIRNATY for administration of a third dose, or “booster” dose, of the COVID-19 vaccine, in individuals 16 years of age and older.

:: Vaccines and Related Biological Products Advisory Committee September 30, 2021 Meeting Announcement – 09/30/2021 – 09/30/2021
Agenda
…Under Topic I, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). Also, on September 30, 2021, under Topic II, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season…

 

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White House [U.S.]
Briefing Room – Selected Major COVID Announcements

A Path out of the Pandemic
Read President Biden’s COVID-19 Action Plan
President Biden is implementing a six-pronged, comprehensive national strategy that employs the same science-based approach that was used to successfully combat previous variants of COVID-19 earlier this year. This plan will ensure that we are using every available tool to combat COVID-19 and save even more lives in the months ahead, while also keeping schools open and safe, and protecting our economy from lockdowns and damage.

Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials
September 10, 2021 • Press Briefings

Remarks by President Biden on Fighting the COVID-⁠19 Pandemic
September 09, 2021 • Speeches and Remarks

Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors
September 09, 2021 • Presidential Actions

Executive Order on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees
September 09, 2021 • Presidential Actions

Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

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Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

 

European Medicines Agency
News & Press Releases
News: Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer (new)
CHMP, Last updated: 09/09/2021

 

News: EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty (new)
Last updated: 06/09/2021
EMA has started evaluating an application for the use of a booster dose of Comirnaty to be given 6 months after the second dose in people aged 16 years and older. Booster doses are given to vaccinated people (i.e. people who have completed their primary vaccination) to restore protection after it has waned.
EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Comirnaty, including results from an ongoing clinical trial in which around 300 adults with healthy immune systems received a booster dose approximately 6 months after the second dose….

 

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European Centre for Disease Prevention and Control
https://www.ecdc.europa.eu/en
Latest Updates
No new digest content identified

 

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Data as of 2021-09-10
https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab

 

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European Commission
https://ec.europa.eu/commission/presscorner/home/en
No new digest content identified

India: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

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India: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

 

Ministry of Health and Family Welfare
https://www.mohfw.gov.in/

Latest Updates
No new digest content identified

 

Government of India – Press Information Bureau
Latest Press Releases
PM lauds Goa for 100% first dose vaccination in Goa
Posted on: 10 Sep 2021

PM chairs a high level meeting to review the Covid-19 related situation and vaccination
Posted on: 10 Sep 2021
:: PM briefed about the augmentation of healthcare infrastructure
:: States asked to maintain buffer stock of medicines in every district
:: PM reviewed production, supply and pipeline of vaccines for next few months
:: PM spoke about the need for constant genome sequencing to monitor emergence of mutants.
Posted On: 10 SEP 2021 8:38PM by PIB Delhi
PM Narendra Modi chaired a high level meeting to review the Covid-19 related situation. The topics covered included a review of the prevailing Covid-19 scenario, preparedness of the health systems to respond, availability of medical oxygen and matters relating to production, supply and distribution of  Covid-19 vaccine…

 

Indian Council for Medical Research (ICMR)
https://www.icmr.gov.in/media.html
Press Releases
No new digest content identified

China: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

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China: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

Xi: China to donate another 100m doses of COVID vaccines
2021-09-10
China will donate 100 million more doses of COVID-19 vaccines to developing countries within this year on top of a donation of $100 million to COVAX, President Xi Jinping said on Sept 9.

POLIOPublic Health Emergency of International Concern (PHEIC)

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Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)
https://polioeradication.org/polio-today/polio-now/this-week/

Polio this week as of 09 September 2021
:: “We re-affirm our commitment to eradicate polio… We note the critical role that adaptable surveillance capacity, like that found in the Global Polio Eradication Initiative, has in the ability to reach vulnerable communities to prevent and respond to pandemics.” – G20 Health Ministers.

 

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
:: Nigeria: 18 cVDPV2 cases

 

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WHO/OCHA Emergencies

 

Editor’s Note:
WHO has apparently reorganized and fundamentally shifted how it judges and tracks “emergencies”. We found no announcement of descriptive information to share and present the webpage structure as encountered below. Obviously, the dates associated with some of these emergencies suggest that this is an archival platform as well as a current emergencies resource.

Health emergencies list – WHO
“The health emergencies list details the disease outbreaks, disasters and humanitarian crises where WHO plays an essential role in supporting countries to respond to and recover from emergencies with public health consequences.”

Crisis in Tigray, Ethiopia [Last apparent update: 5 Aug 2021]

Ebola outbreak, Democratic Republic of the Congo, 2021 [Last apparent update: 17 Aug 2021]

Ebola outbreak outbreak, N’Zerekore, Guinea, 2021 [Last apparent update: 17 Aug 2021]

Coronavirus disease (COVID-19) pandemic [See COVID above]

 

Ebola outbreak, Equateur Province, Democratic Republic of the Congo, 2020
[Last apparent update: 17 Aug 2021]

Ebola outbreak, North Kivu, Ituri, Democratic Republic of the Congo, 2018 – 2020
[Last apparent update: 17 Aug 2021]

Ebola outbreak, Democratic Republic of the Congo, 2018 [Last apparent update: 24 July 2018]

Yemen crisis [Last apparent update: 12 February 2021]

Syria crisis [Last apparent update: 18 June 2021]

Somalia crisis [Last apparent update: 24 March 2018]

Nigeria crisis [Last apparent update: 9 May 2018]

Ebola outbreak, Democratic Republic of the Congo, 2017 [Last apparent update: 17 Aug 2021]

Zika virus disease outbreak, 2015-2016 [Last apparent update: 24 Jan 2020]

Ebola outbreak: West Africa, 2014-2016 [Last apparent update: 17 Aug 2021]

Iraq crisis [Last apparent update: 9 Jan 2008]

South Sudan crisis [Last apparent update: 23 Sep 2020]

Avian influenza A (H7N9) virus outbreak
:: 13 September 2021 News release
Upcoming WHO Consultation on the Composition of Influenza Virus Vaccines for the Southern Hemisphere 2022

Middle East respiratory syndrome (MERS-CoV) outbreak [Last apparent update: 8 July 2019]

Influenza A (H1N1) virus, 2009-2010 pandemic [Last apparent update: 10 Aug 2010]

 

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UN OCHA – Current Emergencies
Current Corporate Emergencies
Northern Ethiopia
Ethiopia Humanitarian Bulletin Issue #12 16 August – 5 Sep …

 

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CDC/ACIP [U.S.] [to 11 Sep 2021]

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CDC/ACIP [U.S.] [to 11 Sep 2021]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
AmeriCorps and CDC Launch Public Health AmeriCorps, Seek Proposals to Build a New Generation of Public Health Leaders
Wednesday, September 8, 2021

Next ACIP Meeting – September 29, 2021, 10:00 a.m. – 5:30 p.m. virtual meeting.
No registration is required to watch the webcast.
No agenda posted as 11 Sep 2021
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MMWR News Synopsis Friday, September 10, 2021
:: Long-Term Symptoms Among Adults Tested for SARS-CoV-2 — United States, January 2020–April 2021
:: Using Wastewater Surveillance Data to Support the COVID-19 Response — United States, 2020–2021
:: SARS-CoV-2 Transmission to Masked and Unmasked Close Contacts of University Students with COVID-19 — St. Louis, Missouri, January–May 2021
:: Trends in COVID-19 Cases, Emergency Department Visits, and Hospital Admissions Among Children and Adolescents Aged 0–17 Years — United States, August 2020–August 2021
:: Hospitalizations Associated with COVID-19 Among Children and Adolescents — COVID-NET, 14 States, March 1, 2020–August 14, 2021

Coronavirus Disease 2019 (COVID-19)– CDC
Approximately 25 announcements/reports/data summaries.
:: Overall US COVID-19 Vaccine Distribution and Administration Update as of Sat, 11 Sep 2021 06:00:00 EST

China CDC

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China CDC http://www.chinacdc.cn/en/

National Health Commission of the People’s Republic of China [to 11 Sep 2021]
http://en.nhc.gov.cn/
News
Sept 11: Daily briefing on novel coronavirus cases in China
On Sept 10, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 25 new cases of confirmed infections

National Medical Products Administration – PRC [to 11 Sep 2021]
http://english.nmpa.gov.cn/news.html
News
Seminar held to boost drug regulatory cooperation between BRI countries
2021-09-11
Co-sponsored by China’s National Medical Products Administration (NMPA) and Ministry of Commerce, the Seminar on Drug Regulation and Development Cooperation for Belt and Road Countries and the Opening Session of the Seminar on Regulation Cooperation and Industry Development of Medical Products for Belt and Road Countries were held in Beijing both online and offline on Sept 1.

Xi: China to donate another 100m doses of COVID vaccines
2021-09-10
China will donate 100 million more doses of COVID-19 vaccines to developing countries within this year on top of a donation of $100 million to COVAX, President Xi Jinping said on Sept 9.

Nearly 2.12b doses of COVID-19 vaccines administered in China
2021-09-09
Nearly 2.12 billion doses of COVID-19 vaccines had been administered in China as of Tuesday, data from the National Health Commission showed on Sept 8.

CCDC Weekly – Weekly Reports: Current Volume (3)
2021-09-10 / No. 37
PDF of this issue
No new digest content identified.

Organization Announcements

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::::::

 

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 11 Sep 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
Sped-up evolution may have molded the human brain by slowing neuron growth
September 9, 2021
Quickly evolving stretches of DNA unique to humans are important for brain development, a new study finds
 
 
BARDA – U.S. Department of HHS [to 11 Sep 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
News
No new digest content identified.
 
 
BMGF – Gates Foundation [to 11 Sep 2021]
https://www.gatesfoundation.org/ideas/media-center
Press Releases and Statements
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute [to 11 Sep 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 11 Sep 2021]
https://carb-x.org/
News
No new digest content identified.
 
 
Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 11 Sep 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 – September 2021 is now posted here
 
 
CEPI – Coalition for Epidemic Preparedness Innovations [to 11 Sep 2021]
http://cepi.net/
Latest News
Joint COVAX statement on Supply Forecast for 2021 and early 2022
According to its latest Supply Forecast, COVAX expects to have access to 1.425 billion doses of vaccine in 2021.
08 Sep 2021
[See Milestones above for detail]

Comparator vaccines are needed if vital COVID-19 R&D is to progress
Governments, developers, and particularly vaccine manufacturers, must urgently agree upon a solution to unlock supplies, writes CEPI’s Director of Vaccine R&D, Melanie Saville.
07 Sep 2021
[See Milestones above for detail]
 
 
DARPA – Defense Advanced Research Projects Agency [to 11 Sep 2021
https://www.darpa.mil/news
News
No new digest content identified.
 
 
Duke Global Health Innovation Center [to 11 Sep 2021]
https://dukeghic.org/
Our Blog
A Call for a Global Summit to End the COVID-19 Pandemic
SEPTEMBER 1, 2021
Endorsed by a broad coalition of leaders and organizations.
[See Milestones above for detail]
 
 
EDCTP [to 11 Sep 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 11 Sep 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.
 
 
European Vaccine Initiative [to 11 Sep 2021]
http://www.euvaccine.eu/
Latest News
No new digest content identified.
 
 
Fondation Merieux [to 11 Sep 2021]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.
 
 
Gavi [to 11 Sep 2021]
https://www.gavi.org/
8 September 2021
First delivery of German-donated COVID vaccines to COVAX land in Mauritania, with other deliveries to follow

8 September 2021
Joint COVAX statement on Supply Forecast for 2021 and early 2022
[See Milestones above for deatil]

 
 

7 September 2021
Gavi funding boosts yellow fever diagnostics capacity across Africa

6 September 2021
First doses donated by Belgium through COVAX arrive to Armenia

GHIT Fund [to 11 Sep 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 11 Sep 2021]
https://www.theglobalfund.org/en/news/
News & Stories
News
Global Fund Results Report Reveals COVID-19 Devastating Impact on HIV, TB and Malaria Programs
08 September 2021
The COVID-19 pandemic had a devastating impact on the fight against HIV, TB and malaria in 2020, according to a new report released by the Global Fund today. The Results Report shows that while some progress was made, key programmatic results have declined for the first time in the history of the Global Fund.
 
 
Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 11 Sep 2021]
https://www.glopid-r.org/news/
GloPID-R Scientific Advisory Group releases report with COVID-19 research priorities and recommendations
06/09/2021
[See Milestones above for detail]
 
 
Hilleman Laboratories [to 11 Sep 2021]
http://www.hillemanlabs.org/
Website reports “under maintenance” at inquiry
 
 
Human Vaccines Project [to 11 Sep 2021]
http://www.humanvaccinesproject.org/
News
No new digest content identified.
 
 
IAVI [to 11 Sep 2021]
https://www.iavi.org/newsroom
Latest News
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 11 Sep 2021]
https://www.icrc.org/en/whats-new
Selected News Releases, Statements, Reports
No new digest content identified.

 
 

IFFIm
http://www.iffim.org/
Press Releases/Announcements
No new digest content identified.
 
 
IFRC [to 11 Sep 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.
 
 
Institut Pasteur [to 11 Sep 2021]
https://www.pasteur.fr/en/press-area
Press Documents
No new digest content identified.
 
 
IOM / International Organization for Migration [to 11 Sep 2021]
http://www.iom.int/press-room/press-releases
News
No new digest content identified.
 
 
ISC / International Science Council [to 11 Sep 2021]
https://council.science/current/
ISC is a non-governmental organization with a unique global membership that brings together 40 international scientific Unions and Associations and over 140 national and regional scientific organizations including Academies and Research Councils.
News
No new digest content identified.
 
 
IVAC [to 11 Sep 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.
 
 
IVI [to 11 Sep 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
IVI’s 20th International Vaccinology Course brings virtual training to vaccine professionals and students across 155 countries
 
 
Johns Hopkins Center for Health Security [to 11 Sep 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
No new digest content identified.
 
 
MSF/Médecins Sans Frontières [to 11 Sep 2021]
http://www.msf.org/
Latest [Selected Announcements]
 
 
Ethiopia
Amid enormous needs in Ethiopia, MSF forced to suspend majority of healthcare
Statement 10 Sep 2021

Afghanistan
Afghanistan: Medical needs grow as international organisations suspend activities
Voices from the Field 6 Sep 2021
 
 
National Academy of Medicine – USA [to 11 Sep 2021]
https://nam.edu/programs/
Selected News/Programs
No new digest content identified.
 
 
National Academy of Sciences – USA [to 11 Sep 2021]
http://www.nasonline.org/news-and-multimedia/
News
No new digest content identified.
 
 
National Vaccine Program Office – U.S. HHS [to 11 Sep 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
Upcoming Meetings
September 14-15, 2021 NVAC Meeting
 
 
NIH [to 11 Sep 2021]
http://www.nih.gov/news-events/news-releases
News Releases
NIH providing $185 million for research to advance understanding of how human genome functions
Thursday, September 9, 2021
The newly launched Impact of Genomic Variation on Function (IGVF) consortium to include 30 U.S. sites.
 
 
PATH [to 11 Sep 2021]
https://www.path.org/media-center/
Press Releases
PATH welcomes Nabeel Goheer as Chief of Asia, Middle East, Europe (AMEE) Region
September 10, 2021
Dr. Nabeel Goheer is joining PATH to serve as the Chief of Asia, Middle East, Europe (AMEE) Region. In this role, he will provide strategic leadership and guidance, overseeing program activities in the regional hubs in South Asia, South East Asia, Eastern Europe, Central Asia, China, and Western Europe, as well as PATH’s other projects in the region. He will also develop and execute on strategies to expand and grow the AMEE portfolio into new regions, including the Middle East and additional countries in Asia…
 
 
Sabin Vaccine Institute [to 11 Sep 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.
 
 
UNAIDS [to 11 Sep 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
8 September 2021
Central African Republic adopts plan to address gender inequality in the AIDS response

6 September 2021
Global roll-out of HIV treatment has saved millions of lives

6 September 2021
Anambra, Nigeria, commits to eliminating vertical transmission of HIV by end of 2022
 
 
UNHCR Office of the United Nations High Commissioner for Refugees [to 11 Sep 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected News Releases, Announcements
No new digest content identified.

UNICEF [to 11 Sep 2021]
https://www.unicef.org/media/press-releases
Press Releases, News Notes, Statements [Selected]
Press release
09/08/2021
Repeated school closures due to COVID-19 leading to learning loss and widening inequities in South Asia, UNICEF research shows
Limited access to devices, low connectivity, and limited teacher contact are severely constraining remote learning in the region

Statement
09/08/2021
Joint COVAX statement on supply forecast for 2021 and early 2022
[See Milestones above for detail]

Remarks
09/07/2021
UNICEF Executive Director Henrietta Fore’s Remarks at the UNICEF Executive Board
As prepared for delivery

Unitaid [to 11 Sep 2021]
https://unitaid.org/
Featured News
No new digest content identified.
 
 
Vaccine Equity Cooperative [nee Initiative] [to 11 Sep 2021]
https://vaccineequitycooperative.org/news/
News
No new digest content identified.
 
 
Vaccination Acceptance & Demand Initiative [Sabin) [to 11 Sep 2021]
https://www.vaccineacceptance.org/
Announcements
No new digest content identified.
 
 
Vaccine Confidence Project [to 11 Sep 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 11 Sep 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.
 
 
Wellcome Trust [to 11 Sep 2021]
https://wellcome.ac.uk/news
News and reports
Photo story
The next pandemic: Why deforestation in DRC could release new viruses
6 September 2021
Authors: Amelia Goldsmith, Hugh Kinsella Cunningham
Covid-19 alerted the world to the devastating potential of pandemics in the 21st century. Photojournalist Hugh Kinsella Cunningham and writer and public health professional, Amelia Goldsmith, document how the lasting effects of colonisation, including the unbridled exploitation of natural resources, in the Democratic Republic of the Congo, could expose humanity to the next supervirus.
 
 
The Wistar Institute [to 11 Sep 2021]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.
 
 
WFPHA: World Federation of Public Health Associations [to 11 Sep 2021]
https://www.wfpha.org/
Latest News
No new digest content identified.
 
 
World Bank [to 11 Sep 2021]
http://www.worldbank.org/en/news/all
Selected News, Announcements
The World Bank, UNICEF Support COVID-19 Vaccine Deployment and Lifesaving Health Services for Children and Women in South Sudan
JUBA, September 09, 2021 – The World Bank and UNICEF are collaborating to implement a $53.5 million project in South Sudan that focuses on COVID-19 (Coronavirus) vaccine deployment in the country and the provision of essential health services for the most vulnerable populations in two of the most hard-to-reach areas – the states of Jonglei and Upper Nile.

This close collaboration between the World Bank and UNICEF in South Sudan comes at a crucial time as the country continues to respond to the COVID-19 pandemic including the scaling up of its vaccination roll out efforts. Both sides will also support the Ministry of Health in enhancing its stewardship of the South Sudanese health system and its capacity to plan and implement programs.

“The World Bank values its partnership with UNICEF as it focuses on the urgent task of COVID19 vaccine deployment and the supply of life-saving interventions to the most vulnerable children and women in South Sudan. It also seeks to build capacity of the Ministry of Health at the national, state and community levels to ensure sustainable access to basic health services for all resident of the country,” said Firas Raad, World Bank Country Manager for South Sudan.

Through this collaboration, initiated in 2018, UNICEF has been implementing a World Bank-financed health sector project that provides essential maternal and child health services in Jonglei and Upper Nile. The project has so far immunized 126,489 children with the penta3 vaccine and 127,912 children with the measles vaccines and provided 55,404 pregnant women with antenatal care services. It also ensured that 20,651 new-borns were delivered with the help of skilled health personnel. The project also facilitated the delivery of 587 tons of medical supplies and medicines; and supplied soap, buckets, and water purification tablets for 685,000 people in both states…

COVID-19 vaccines: from rejection to shortage, how Côte d’Ivoire became a model for managing vaccine hesitancy
ABIDJAN, Sept 7, 2021— One month after Côte d’Ivoire’s vaccination campaign was launched with much fanfare, the great enthusiasm generated by the delivery of 504,000 doses of the AstraZeneca vaccine on…
Date: September 07, 2021 Type: Feature Story
 
 
World Customs Organization – WCO [to 11 Sep 2021]
http://www.wcoomd.org/
Latest News – Selected Items
No new digest content identified.
 
 
World Organisation for Animal Health (OIE) [to 11 Sep 2021]
https://www.oie.int/en/for-the-media/press-releases/2021/
Press Releases, Statements
No new digest content identified.
 
 
WTO – World Trade Organisation [to 11 Sep 2021]
http://www.wto.org/english/news_e/news_e.htm
WTO News and Events
No new digest content identified.

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ARM [Alliance for Regenerative Medicine] [to 11 Sep 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Selected Press Releases
No new digest content identified.
 
 
BIO [to 11 Sep 2021]
https://www.bio.org/press-releases
Press Releases, Letters, Testimony, Comments [Selected]
No new digest content identified.
 
 
DCVMN – Developing Country Vaccine Manufacturers Network [to 11 Sep 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.
 
 
ICBA – International Council of Biotechnology Associations [to 11 Sep 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.
 
 
IFPMA [to 11 Sep 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Momentum of COVID-19 vaccine manufacturing scale up sufficient for step change in distribution
07 September 2021
[See Milestones above for detail]

R&D-based pharmaceutical industry’s innovative partnerships to meet urgent global supply needs
06 September 2021 :: 3 pages
… According to Airfinity data, as of September 2021 at least 323 manufacturing and production agreements for COVID-19 vaccines – of which 230 agreements involving technology transfer- around the globe were made public…

 
 

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
No new digest content identified.
 
 
International Alliance of Patients’ Organizations – IAPO [to 11 Sep 2021]
https://www.iapo.org.uk/news/topic/6
Press and media [Selected]
No new digest content identified.
 
 
PhRMA [to 11 Sep 2021]
http://www.phrma.org/
Latest News [Selected]
A year and a half later: The biopharmaceutical industry remains committed to beating COVID-19
September 8, 2021
As an industry committed to science, our work is not over.
…Globally, vaccine manufacturers are also estimated to produce more than 11 billion doses of COVID-19 vaccines by the end of 2021 and have already delivered more than 5 billion doses around the globe…
Blog Post

Journal Watch

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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

How Differently Should the FDA Regulate Drugs and Devices?

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AMA Journal of Ethics
Volume 23, Number 9: E667-756 Sep 2021
https://journalofethics.ama-assn.org/issue/implantable-material-and-device-regulation

 

Implantable Material and Device Regulation
About 10% of Americans will have a device implanted into their bodies during their lifetimes. Fewer than 0.5% of these devices, however, are likely to have been tested in rigorous clinical trials generally regarded as standard by US regulators. Despite looser regulation of materials and devices than for pharmaceuticals, clinician-investigators and the Food and Drug Administration are obligated to balance patient-subjects’ safety with demand for patients’ timely access to technologies and interventions that might improve or extend their lives. This issue investigates that tension.
From the Editor
Sep 2021
How Differently Should the FDA Regulate Drugs and Devices?
Ariel Wampler, MD
This issue invites clinicians, researchers, device representatives, and patient-safety champions to consider how to exercise sufficient caution without stifling innovation.

Strategies for Successful Vaccination Among Two Medically Underserved Populations: Lessons Learned From Hepatitis A Outbreaks

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American Journal of Public Health
August 2021 111(53)
http://ajph.aphapublications.org/toc/ajph/current

 

PERSPECTIVES
Strategies for Successful Vaccination Among Two Medically Underserved Populations: Lessons Learned From Hepatitis A Outbreaks
Substance Use, Infections, Health Service Delivery, Hepatitis, Immunization/Vaccines, Public Health Practice, Community Health, Drugs, Access to Care
Martha P. Montgomery, Maribeth Eckert, Megan G. Hofmeister, Monique A. Foster, Mark K. Weng, Ryan Augustine, Neil Gupta and Laura A. Cooley

Tribal Sovereignty in Research and Community Engagement for a COVID-19 Vaccine Clinical Trial on the Navajo Nation: Beyond a Facebook Town Hall

Posted on by

American Journal of Public Health
August 2021 111(53)
http://ajph.aphapublications.org/toc/ajph/current

 

PERSPECTIVES
Tribal Sovereignty in Research and Community Engagement for a COVID-19 Vaccine Clinical Trial on the Navajo Nation: Beyond a Facebook Town Hall
Other Statistics/Evaluation/Research, Immunization/Vaccines, Native Americans, Statistics/Evaluation/Research, Community Health, Race/Ethnicity, Media
Laura L. Hammitt, Deionna E. Vigil and Raymond Reid

Toward a New Strategic Public Health Science for Policy, Practice, Impact, and Health Equity

Posted on by

American Journal of Public Health
August 2021 111(53)
http://ajph.aphapublications.org/toc/ajph/current

 

POLICY
Toward a New Strategic Public Health Science for Policy, Practice, Impact, and Health Equity
Other Statistics/Evaluation/Research, Prevention, Environment, Statistics/Evaluation/Research
Rebecca Bunnell, Juliet Ryan, Charlotte Kent and the CDC Office of Science and CDC Excellence in Science Committee