Vaccines and Global Health: The Week in Review :: 18 September 2021

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: 

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

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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– 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.

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

COVID

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 them 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 COVID-19 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 calls on world leaders at the UN General Assembly to focus on vaccine equity, pandemic preparedness, and getting the SDGs back on track

Milestones :: Perspectives :: Research

 

WHO calls on world leaders at the UN General Assembly to focus on vaccine equity, pandemic preparedness, and getting the SDGs back on track
17 September 2021 News release Geneva
WHO is urging leaders attending the 76th session of the United Nations General Assembly (UNGA) to guarantee equitable access to COVID-19 vaccines and other life-saving tools; ensure the world is better prepared to respond to future pandemics; and renew efforts to achieve the Sustainable Development Goals (SDGs).

The COVID-19 pandemic has already claimed the lives of nearly 5 million people around the globe, and the virus continues to circulate actively in all regions of the world.

Vaccines are the most critical tool to end the pandemic and save lives and livelihoods. More than 5.7 billion vaccine doses have been administered globally, but 73% of all doses have been administered in just 10 countries. High-income countries have administered 61 times more doses per inhabitant than low-income countries. The longer vaccine inequity persists, the more the virus will keep circulating and evolving, and the longer the social and economic disruption will continue.

WHO’s targets are to vaccinate at least 40% of the population of every country by the end of this year, and 70% by the middle of next year. These targets are achievable if countries and manufacturers make a genuine commitment to vaccine equity.

WHO is calling on countries to fulfil their dose-sharing pledges immediately and to swap their near-term vaccine deliveries with COVAX and AVAT (African COVID-19 Vaccine Acquisition Task Team); WHO is also calling on manufacturers to prioritize supplies to COVAX and partners, and for countries and manufacturers to facilitate the sharing of technology, know-how and intellectual property to support regional vaccine manufacturing.

Even as countries focus on ending this pandemic, the world must also prepare for future pandemics and other health emergencies.

COVID-19 caught the world – including wealthy nations – unprepared for a pandemic of this speed and scale. It hit vulnerable populations particularly hard and exacerbated inequalities.

 

WHO urges all countries to break the cycle of ‘panic and neglect’ seen after previous health emergencies, and commit adequate financial resources, as well as political will, to strengthening health emergency preparedness across the globe…

Statement by White House Press Secretary Jen Psaki on COVID-⁠19 Summit

Milestones :: Perspectives :: Research

 

Statement by White House Press Secretary Jen Psaki on COVID-⁠19 Summit
September 17, 2021 • Statements and Releases
On Wednesday September 22 President Biden will convene a virtual COVID Summit on the margins of the UN General Assembly. This meeting is about expanding and enhancing our shared efforts to defeat COVID-19, building out from previous gatherings of world leaders and ministers in fora like the G7, G20, and Act Accelerator to rally civil society, NGOs, philanthropists, and industry along with world leaders and align on a common vision for defeating COVID-19 together.

We will be asking participants to commit to of a higher level of ambition across four themes:
:: Vaccinate the World by enhancing equitable access to vaccines and getting shots in arms.
:: Save Lives Now by solving the oxygen crisis, and making tests, therapeutics and PPE more available.
:: Build Back Better by establishing a sustainable health security financing mechanism, and global leadership for emerging threats.
:: Calling the World to Account by aligning around targets, tracking progress, and supporting one another in fulfilling our commitments.
We will have more to share on the COVID Summit in the coming days.

International organizations, vaccine manufacturers agree to intensify cooperation to deliver COVID-19 vaccines

Milestones :: Perspectives :: Research

 

International organizations, vaccine manufacturers agree to intensify cooperation to deliver COVID-19 vaccines
16 September 2021
The heads of the International Monetary Fund, World Bank Group, World Health Organization and World Trade Organization met with the CEOs of leading vaccine manufacturing companies to discuss strategies to improve access to COVID-19 vaccines, especially in low— and lower middle-income countries and in Africa. The Task Force expressed concerns that without urgent steps the world is unlikely to achieve the end-2021 target of vaccinating at least 40% of the population in all countries — a critical milestone to end the pandemic and for global economic recovery

The Task Force members noted that, despite adequate total global vaccine production in the aggregate, the doses are not reaching low- and lower middle-income countries in sufficient amounts, resulting in a crisis of vaccine inequity. The Task Force encouraged countries that have contracted high amounts of vaccine doses, and vaccine manufacturers, to come together in good faith to urgently accelerate COVID-19 vaccine supplies to COVAX and AVAT, two multilateral mechanisms that are crucial for equitable distribution of vaccines.

Task Force members welcomed the willingness of the CEOs to work collectively with them to end vaccine inequity and their readiness to form a technical working group with the Task Force to exchange and coordinate information on vaccine production and deliveries.

 

The Task Force stressed that if the 40% coverage threshold is to be reached in all countries by the end of 2021, the following actions need to be taken immediately by governments and vaccine manufacturers: 

:: Release doses to low- and lower middle-income countries: Task Force members take note that countries with high vaccination rates have collectively pre-purchased over two billion doses in excess of what is required to fully vaccinate their populations. The Task Force calls again on those countries to urgently:
swap their near-term delivery schedules with COVAX and AVAT,
fulfill their dose donation pledges with unearmarked upfront deliveries to COVAX, and
iii) release vaccine companies from options and contracts so those doses can be delivered to people in low- and lower middle-income countries. In addition, vaccine manufacturers should prioritize and fulfill their contracts to COVAX and AVAT.

:: Transparency on supply of vaccines: To ensure that doses reach countries that need them the most, particularly low- and lower middle-income countries, the Task Force calls on vaccine manufacturers to share details on month-by-month delivery schedules for all vaccine shipments, especially for COVAX and AVAT. In its remarks, WHO emphasized its call for a moratorium on booster doses until the end of 2021, with the exception of the immune-compromised, to help optimize supply to low-income countries.

:: Eliminate export restrictions, prohibitions: The Task Force calls on all countries to urgently address export restrictions, high tariffs and customs bottlenecks on COVID-19 vaccines and the raw materials and supplies required for the production and timely distribution of vaccines.

:: Regulatory streamlining and harmonization: The Task Force calls on all regulatory authorities around the world to create regulatory consistency and standardization on the approval of vaccines, and to support the acceptance of the WHO Emergency Use Listing procedure. In parallel, efforts should be made to boost production of vaccines, diagnostics and treatments globally and expedite equitable delivery of such lifesaving tools to developing countries.

Leaders Make Urgent Call To Accelerate Vaccination Globally And In Africa

Milestones :: Perspectives :: Research

 

Leaders Make Urgent Call To Accelerate Vaccination Globally And In Africa
14 September 2021 News release Geneva
WHO Director-General Dr Tedros Adhanom Ghebreyesus and a group of global health leaders today issued an urgent call for vaccine equity globally and in Africa in particular. The leaders stressed that the worst pandemic in the last hundred years will not end unless and until, there is genuine global cooperation on vaccine supply and access. They also reiterated the WHO’s global vaccination target for 70% of the population of all countries to be vaccinated by mid- 2022.
Dr Tedros was joined by Dr Seth Berkley, CEO Gavi, Strive Masiyima, AU Special Envoy for COVID- 19, Dr John Nkengasong, Africa CDC Director, Professor Benedict Oramah, President and Chairman of the Board of Directors, Afreximbank, Dr Vera Songwe, UN Under- Secretary- General and Executive Secretary of the Economic Commission For Africa and Dr Matshidiso Moeti, WHO Regional Director for Africa.
The press conference followed two days of meetings among the leaders, with Richard Hatchett, Chief Executive Officer of CEPI joining the meetings as well…

Africa faces 470 million COVID-19 vaccine shortfall in 2021

Milestones :: Perspectives :: Research

 

Africa faces 470 million COVID-19 vaccine shortfall in 2021
WHO – Africa Region
16 September 2021
Brazzaville – As the COVAX Facility is forced to slash planned COVID-19 vaccine deliveries to Africa by around 150 million this year, the continent faces almost 500 million doses short of the global year-end target of fully vaccinating 40% of its population. This shortfall comes as Africa tops 8 million COVID-19 cases this week.

With the cutback COVAX is now expected to deliver 470 million doses to Africa this year. These will be enough to vaccinate just 17% of the population, far below the 40% target. An additional 470 million doses are needed to reach the end-year target even if all planned shipments via COVAX, a multilateral initiative aimed at guaranteeing global access to lifesaving COVID-19 vaccines, and the African Union are delivered.

“Export bans and vaccine hoarding have a chokehold on vaccine supplies to Africa. As long as rich countries lock COVAX out of the market, Africa will miss its vaccination goals. The huge gap in vaccine equity is not closing anywhere near fast enough. It is time for vaccine manufacturing countries to open the gates and help protect those facing the greatest risk,” said Dr Matshidiso Moeti, World Health Organization (WHO) Regional Director for Africa.

As export bans, challenges in boosting production at COVAX manufacturing sites and delays in filing for regulatory approvals for new vaccines constrain deliveries, COVAX has called for donor countries to share their supply schedules to give more clarity on deliveries.

COVAX has also called for countries with enough vaccines to give up their place in the queue for deliveries.Manufacturers must deliver to COVAX in line with firm commitments, and countries that are well-advanced with vaccinations must expand and accelerate donations, ensuring doses are available in larger, more predictable volumes and with longer shelf lives.

About 95 million more doses are set to arrive in Africa via COVAX throughout September, which will be the largest shipment the continent receives for any month so far. Yet even as deliveries pick up, Africa has been able to fully vaccinate just 50 million people, or 3.6% of its people.

Around 2% of the nearly 6 billion doses given globally have been administered in Africa. The European Union and the United Kingdom have vaccinated over 60% of their people and high-income countries have administered 48 times more doses per person than low-income nations.

“The staggering inequity and severe lag in shipments of vaccines threatens to turn areas in Africa with low vaccination rates into breeding grounds for vaccine-resistant variants. This could end up sending the whole world back to square one,” said Dr Moeti…

UNHCR warns of dire consequences for refugees from COVID-19 underfunding

Milestones :: Perspectives :: Research

 

UNHCR warns of dire consequences for refugees from COVID-19 underfunding
This is a summary of what was said by UNHCR’s Chief of Public Health Section, Ann Burton – to whom quoted text may be attributed – at today’s press briefing at the Palais des Nations in Geneva.
17 September 2021   |
UNHCR, the UN Refugee Agency, calls for more global attention and funding support, to counter the impact of COVID-19 on forcibly displaced people worldwide.

The COVID-19 emergency tops the list of UNHCR’s top-10 underfunded situations in 2021. Only one third of the budgeted requirements of US$ 924 million has been received, leaving a yawning gap in UNHCR’s ability to protect the most vulnerable from the fallout of the pandemic.

Despite progress in many locations where UNHCR is working, we continue to see new cases and people continue to die. While safe and effective vaccines can relieve pressures on health systems and save lives, vaccine inequity continues to hit the hardest in many refugee-hosting states. We know that 86 per cent of refugees are hosted in developing countries. However, some 80 per cent of all vaccine doses have been given in high- and upper middle-income countries.

At the same time, low-income countries, hosting the bulk of the world’s refugees, have the least resilient health systems and are struggling to cope with the needs of their own populations – before we add the extra needs posed by hosting refugees. As UNHCR, we reiterate our call on states to share excess doses with COVAX in a timely way, to address the global vaccine inequity and avoid prolonging the pandemic.

Until now, we have been very encouraged by the overwhelming response of hosting states in including refugees in the vaccine roll-out and urge them to continue to do so. However, we have seen that many barriers to vaccine access remain. UNHCR stands ready to support states to overcome some of these barriers – provided we have the means to do so – for example, by creating information materials in refugee languages suitable for low literacy levels.

The pandemic hurts forcibly displaced and stateless people in ways that reach far beyond the risk posed by the virus itself. And the failure to adequately fund the response only deepens their plight.

COVID Vaccines – OCHA:: HDX

Milestones :: Perspectives :: Research

 

COVID Vaccines – OCHA:: HDX

COVID-19 Data Explorer: Global Humanitarian Operations
COVID-19 Vaccine Roll-out
Sep 18, 2021 | COVAX (WHO,GAVI,CEPI), UNDESA, Press Reports | DATA
Global COVID-19 Figures: 227M total confirmed cases; 4.7M total confirmed deaths
Global vaccines administered: 5.88B
Number of Countries: 29 [29 week ago]
COVAX Allocations Round 4-6 (Number of Doses): 120M [120M week ago]
COVAX Delivered (Number of Doses): 87M [85M week ago]
Other Delivered (Number of Doses): 130M [110M week ago]
Total Delivered (Number of Doses): 200M [210M week ago]
Total Administered (Number of Doses): 190M [170M week ago]

 

::::::

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 18 Sep 2021: https://data.covid19taskforce.com/data The global view below is complemented by country-specific dashboards here.

World Bank Vaccine Operations Portal

Milestones :: Perspectives :: Research

 

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 September 9, 2021, the World Bank approved operations to support vaccine rollout in 55 countries amounting to $4.6 billion. See the latest project financing, project documents and procurement information in the list here.

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

Milestones :: Perspectives :: Research

::::::

 

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 :: 226 844 344 [223 022 538 week ago]
Confirmed deaths :: 4 666 334 [4 602 882 week ago]
Vaccine doses administered: 5 634 533 040 [5 352 927 296 week ago]

WHO Director-General’s opening remarks at the media briefing on COVID-19 – 14 September 2021

Milestones :: Perspectives :: Research

 

WHO Director-General’s opening remarks at the media briefing on COVID-19 – 14 September 2021
14 September 2021
:: WHO’s global targets are to support every country to vaccinate at least 40% of its population by the end of this year, and 70% of the world’s population by the middle of next year. So far, just two countries in Africa have reached the 40% target, the lowest of any region. More than 5.7 billion doses have been administered globally, but only 2% of those have been administered in Africa.
:: The longer vaccine inequity persists, the more the virus will keep circulating and changing, the longer the social and economic disruption will continue, and the higher the chances that more variants will emerge that render vaccines less effective. 
:: So far, COVAX has shipped more than 260 million doses to 141 countries. But as you know, COVAX has also faced several challenges, with manufacturers prioritizing bilateral deals and many high-income countries tying up the global supply of vaccines.
:: Last year, the African Union established the African COVID-19 Vaccine Acquisition Task Team, or AVAT, as a compliment to COVAX to purchase vaccines for AU Member States. Yesterday and today, we had a very constructive meeting between partners from COVAX and AVAT to agree on a way forward. Vaccine inequity is a solvable problem.
:: This Friday is World Patient Safety Day. Our theme this year is safe maternal and newborn care. Every day, nearly 5,400 babies are stillborn, and more than 800 women and 6,700 newborns die mainly around the time of childbirth.  We call on all countries, health workers, communities and partners to act now for safe and respectful childbirth.

 

:::::::

Weekly epidemiological update on COVID-19 – 14 September 2021
Overview
With nearly 4 million new cases reported globally in the past week (6-12 September), this represents the first substantial decline in weekly cases in more than two months. All regions reported declines in new cases as compared to the previous week. The number of deaths reported globally in the past week also decreased as compared to the previous week, with just over 62 000 new deaths. The African Region reported an increase in the number of weekly deaths (7%), while the South-East Asia Region reported the largest decrease (20%). The American and Eastern Mediterranean Regions reported slightly smaller decreases, 9% and 6% respectively, while the numbers of deaths reported in the European and the Western Pacific Regions were similar to last week. The cumulative number of cases reported globally is now over 224 million and the cumulative number of deaths is just over 4.6 million.
In this edition, two special focus updates are provided on:
:: SARS-CoV-2 Variants of Concern (VOCs) Alpha, Beta, Gamma and Delta which includes updates on the geographic distribution of VOCs
:: COVID-19 in children and adolescents.

Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 19 August 2021

Milestones :: Perspectives :: Research

 

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]
::::::

 

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

 

AstraZeneca
Press Releases – No new digest announcements identified

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

 

CanSinoBIO
News – [Website not responding at inquiry]

Clover Biopharmaceuticals – China
News – No new digest announcements identified

 

Curevac [Bayer Ag – Germany]
News
September 14, 2021
CureVac Streamlines European Network for mRNA Product Manufacturing
:: CureVac right-sizes manufacturing network to adapt to changes in vaccine peak demands
:: Demand reassessed for first-generation COVID-19 vaccine candidate, CVnCoV, currently under regulatory review with EMA
:: Contracts with manufacturing partners WACKER and Celonic terminated; Rentschler Biopharma and Novartis contracts unaffected

 

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 16, 2021
Moderna Announces Health Canada Approves its COVID-19 Vaccine

September 15, 2021
Moderna Highlights New Clinical Data on its COVID-19 Vaccine
:: mRNA-1273 remains highly effective against COVID-19 in real-world effectiveness study during surge in Delta cases
:: New analysis of open-label portion of Phase 3 COVE study shows lower risk of breakthrough infection in participants vaccinated more recently (median 8 months after first dose) than participants vaccinated last year (median 13 months after first dose)
:: Company believes data support benefit of an mRNA-1273 booster dose

 

Novavax
Press Releases
Novavax Statement on Proof of COVID-19 Vaccine Requirements for PREVENT-19 Clinical Trial Participants in the U.S.
Sep 17, 2021
The U.S. Centers for Disease Control and Prevention (CDC) recently provided updated guidance stating that participants in the Novavax PREVENT-19 Phase 3 clinical trial meet the criteria to be considered fully vaccinated two weeks after they have completed the active vaccine series. With this validation from the United States’ leading public health authority, Novavax expects our PREVENT-19 Phase 3 clinical trial participants will be considered fully vaccinated and in compliance with mandated vaccination policies, including those of employers and any other organizations or entities requiring proof of vaccination. Novavax is grateful to our clinical trial participants for helping to ensure a safer future for all, and we continue to advocate for them at the highest levels.

Novavax to Participate in University of Oxford Com-COV3 Study Comparing Mixed COVID-19 Vaccine Schedule in Adolescents
Sep 16, 2021
– Study to explore heterologous regimen of COVID-19 vaccines from different manufacturers in adolescents 12-16 years of age
– Will assess potential for flexibility in the delivery of COVID-19 vaccines

 

Pfizer
Recent Press Releases
FDA Advisory Committee Votes Unanimously in Favor Of COMIRNATY® Booster for Emergency Use in People 65 and Older and Certain High-risk Populations
09.17.2021
:: Committee reviewed clinical data showing a booster dose of COMIRNATY® elicits high neutralization titers against SARS-CoV-2 and all currently tested variants
:: Reactogenicity profile within seven days of the booster dose was typically mild to moderate, with frequency of reactions similar to or lower than after the primary vaccination series
:: Real-world data presented by Israel Ministry of Health show additional protection after receiving a booster translated to vaccine effectiveness comparable to levels seen early in the country’s vaccine rollout
:: FDA expected to make its decision in the coming days

 

Sanofi Pasteur
Press Releases
September 14 2021 Press releases
Sanofi completes acquisition of Translate Bio, accelerating the application of mRNA in new vaccines and therapeutics
Sanofi announced today the completion of its acquisition of Translate Bio, further accelerating the company’s efforts to develop transformative vaccines and therapies using mRNA technology. The acquisition adds a critical pillar to the company’s mRNA Center of Excellence which aims to unlock the potential of next-generation mRNA vaccines and other strategic areas such as immunology, oncology, and rare diseases…

 

Serum Institute of India
NEWS & ANNOUNCEMENTS
Biocon Biologics and Serum Institute Life Sciences Announce Strategic Alliance
:: BBL will have access to 100 million doses of vaccines annually and commercialization rights of the SILS vaccine portfolio for global markets
:: SILS to receive ~15% stake in BBL at a post-money valuation of ~$4.9 billion
Bengaluru, Karnataka, India – September 16, 2021 Biocon Biologics Limited (BBL), a subsidiary of Biocon Ltd. and Serum Institute Life Sciences Private Limited (SILS), a subsidiary of Serum Institute of India Pvt. Ltd. today announced a strategic alliance.
Under the terms of the agreement, BBL will offer approximately 15% stake to SILS, at a
post-money valuation of ~$4.9 billion, for which it will get committed access to a 100
million doses of vaccines per annum for 15 years, primarily from SILS’s upcoming vaccine
facility in Pune with commercialization rights of the SILS vaccine portfolio (including
COVID-19 vaccines) for global markets…

 

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

 

Sinovac
Press Releases
SINOVAC agrees to supply an additional 101,000 doses of COVID-19 vaccines (CoronaVac®) to meet demand for inactivated virus vaccines from Singapore residents
2021/09/15
· Doses will be available through SGX-Catalist listed Livingstone Health group at 17 clinics islandwide
· Inactivated viral vaccines offer an alternative option for those unable to take up vaccines available under the National Vaccine Programme, or prefer inactivated virus vaccines

 

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]

 

::::::

GSK
Press releases for media – No new digest announcements identified

 

SK Biosciences
Press releases – No new digest announcements identified

Duke – Launch and Scale Speedometer

Milestones :: Perspectives :: Research

 

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

Milestones :: Perspectives :: Research

 

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 18 Sep 2021]: https://data.undp.org/vaccine-equity/
See also visualization on Vaccine Access and Vaccine Affordability

Vaccines and Related Biological Products Advisory Committee- FDA

Vaccines and Related Biological Products Advisory Committee- FDA
:: Vaccines and Related Biological Products Advisory Committee September 17, 2021
Agenda
The committee met 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.
YouTube recording: https://youtu.be/WFph7-6t34M

Editor’s Note:
No FDA announcement on action proceeding from this meeting was identified at 18 Sep 2021 – 1600/New York. We include the Pfizer announcement and coverage from the New York Times below for context:

FDA Advisory Committee Votes Unanimously in Favor Of COMIRNATY® Booster for Emergency Use in People 65 and Older and Certain High-risk Populations
09.17.2021
:: Committee reviewed clinical data showing a booster dose of COMIRNATY® elicits high neutralization titers against SARS-CoV-2 and all currently tested variants
:: Reactogenicity profile within seven days of the booster dose was typically mild to moderate, with frequency of reactions similar to or lower than after the primary vaccination series
:: Real-world data presented by Israel Ministry of Health show additional protection after receiving a booster translated to vaccine effectiveness comparable to levels seen early in the country’s vaccine rollout
:: FDA expected to make its decision in the coming days
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend the FDA grant Emergency Use Authorization (EUA) for a booster dose of COMIRNATY® (COVID-19 Vaccine, mRNA) in individuals 65 years of age and older and individuals at high risk of severe COVID-19. The committee recommended that the additional dose be administered at least six months after the two-dose series. The panel also agreed that healthcare workers and others at high risk for occupational exposure should be included in this EUA…

An FDA panel’s vote deals the Biden administration’s push for universal booster shots a setback.
New York Times, 17 Sep 2021
The Biden administration’s push to make Covid-19 booster shots available to most fully vaccinated adults has been stymied for now by a Food and Drug Administration advisory panel’s recommendation that Pfizer boosters be made available only to those 65 and over and those at high risk of severe Covid.
However, the roiling debate over whether the shots are needed more broadly remains unsettled.
The panel of experts on Friday overwhelmingly voted not to recommend boosters for those over 16 after a tense, daylong debate that put divisions within the agency and the administration on public display.
The vote was a blow to President Biden, strengthening criticism of his effort to enhance the immunity of already vaccinated Americans at a time when most residents of poor nations have not even had first doses. The F.D.A. and the Centers for Disease Control and Prevention authorized third shots for some immunocompromised individuals more than a month ago, on the ground that the additional dose would simply lift their protection to the level other people achieve with two shots.
Some F.D.A. experts said that the data from Pfizer and elsewhere still seemed to show that two shots protected against severe disease or hospitalization for months afterward, and that there was not enough evidence that a third shot would stem the spread of infection. Some also criticized a lack of data that an additional injection would be safe for younger people.
The panel’s final recommendations left some room for the White House to argue that the core of its booster strategy remained intact. Depending on how “at high risk” is defined, tens of millions of Americans could conceivably be deemed eligible for additional shots of the Pfizer vaccine. And a small but growing number of people have stopped waiting for federal authorization and are finding ways to receive booster shots

White House [U.S.]

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

Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials
September 17, 2021 • Press Briefings

Statement by White House Press Secretary Jen Psaki on COVID-⁠19 Summit
September 17, 2021 • Statements and Releases
[See Milestones above for detail]

Executive Order on Adding Measles to the List of Quarantinable Communicable Diseases
September 17, 2021 • Presidential Actions

Remarks by President Biden at a Meeting with Business Leaders and CEOs on the COVID-⁠19 Response
September 15, 2021 • Speeches and Remarks

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

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

 

 

European Medicines Agency
News & Press Releases
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021
News  17/09/2021

 

 

::::::

 

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

 

 

::::::

Data as of 2021-09-17
https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab

 

 

::::::

 

European Commission
https://ec.europa.eu/commission/presscorner/home/en
Press release 17 September 2021
Commissioner Lenarčič visits Haiti as EU  Humanitarian Air Bridge flight reaches the  country
In the context of the continued EU support following the devastating earthquake that hit Haiti on 14 August, Commissioner for Crisis Management Janez Lenarčič is travelling to Haiti today.

Press release 16 September 2021
European Commission announces the New European Bauhaus prize winners
Today, the Commission announced the 20 winners of the ‘New European Bauhaus Awards’ and the ‘New European Bauhaus Rising Stars’.
New European Bauhaus website

Press release 15 September 2021
New European Bauhaus: new actions and funding to link sustainability to style and inclusion
Today, the Commission adopts a Communication setting out the concept of the New European Bauhaus.

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

Russia: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment
Russia: Sputnik V – “the first registered COVID-19 vaccine”
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
The single-component Sputnik Light vaccine authorized in Iran
Press release, 15.09.2021

Sputnik V demonstrates 97.2% efficacy and high safety profile against COVID during the vaccination campaign in Belarus
Press release, 15.09.2021

Study on Sputnik Light (first component of Sputnik V) vaccine’s efficacy among the elderly in Argentina published in EClinicalMedicine journal
Press release, 13.09.2021

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

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
No new digest content identified

 

 

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

China’s Chongqing to vaccinate foreign minors against COVID-19

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

China surpasses 1 billion fully vaccinated
2021-09-17

China’s Chongqing to vaccinate foreign minors against COVID-19
2021-09-17
HONGQING — Southwest China’s Chongqing Municipality will administer COVID-19 vaccines to foreigners aged 12 to 17 from Saturday on a voluntary basis, according to the Chongqing Foreign Affairs Office.
Foreign citizens who are covered by the local health insurance program will enjoy the same policy as insured Chinese people, and those not covered will be charged 100 yuan (about 15.5 U.S. dollars) per dose.
The vaccines are domestically-developed inactivated COVID-19 vaccines, and a total of one or two doses may be required subject to different vaccines…

POLIO Public Health Emergency of International Concern (PHEIC)

Emergencies

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

Polio this week as of 15 September 2021
:: GPEI announced a series of commitments to advance gender equality at the Generation Equality Forum in Paris, organized by UN Women and hosted by the Governments of France and Mexico between June 30 and July 2, 2021. The Forum kickstarted a 5-year journey to accelerate ambitious action and implementation on global gender equality. Read more

 

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
:: Pakistan: three cVDPV2 positive environmental samples
:: Nigeria: 10 cVDPV2 cases
:: Mali: 1 cVDPV2 case

 

::::::
::::::

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]

 

::::::

UN OCHA – Current Emergencies
Current Corporate Emergencies
Afghanistan
 Afghanistan: Weekly Humanitarian Update (6 – 12 September 2021)

Northern Ethiopia
No new digest content identified

 

::::::
::::::

CDC/ACIP [U.S.] [to 18 Sep 2021]

CDC/ACIP [U.S.] [to 18 Sep 2021]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
CDC to Invest $2.1 Billion to Protect Patients and Healthcare Workers from COVID-19 and Future Infectious Diseases
Friday, September 17, 2021
Today, the Biden-Harris Administration announced a $2.1 billion investment to improve infection prevention and control activities across the U.S. public health and healthcare sectors. The Biden-Harris Administration, working through the Centers for Disease Control and Prevention (CDC), is investing American Rescue Plan funding to strengthen and equip state, local, and territorial public health departments and other partner organizations with the resources needed to better fight infections in U.S. healthcare facilities, including COVID-19 and other known and emerging infectious diseases.

The funding announced today is a commitment that will allow the United States to expand public health and improve the quality of healthcare in our country, including addressing healthcare-related inequities. It will assist healthcare personnel to prevent infections more effectively in healthcare settings, support rapid response to detect and contain infectious organisms, enhance laboratory capacity, and engage in innovation targeted at combating infectious disease threats. Improvements in infection prevention will span the healthcare continuum, including 6,000 hospitals, 15,400 nursing homes and other long-term care facilities, 7,900 dialysis clinics, and 4,700 ambulatory surgery centers, and will extend to other outpatient settings.

“This funding will dramatically improve the safety and quality of the healthcare delivered in the United States during the pandemic and in the future,” said CDC Director Rochelle P. Walensky, M.D., M.P.H. “Funding will provide significant resources to our public health departments and healthcare systems and opportunities to develop innovative strategies to protect every segment of the U.S. population, especially those disproportionately affected by the pandemic, at a time that they are hit hard.”
Additionally, these investments will help address the rise of healthcare-associated infections, which increased as U.S. hospitals were inundated by COVID-19—reversing national progress seen prior to the pandemic.

Over the next 3 years, CDC will issue $1.25 billion of the total to 64 state, local, and territorial health departments to support this work. Initial awards totaling $885 million will be made in October 2021 to these jurisdictional health departments. CDC will use the majority of this initial funding in October, $500 million, to support a new force in the fight against COVID-19 to protect our most disproportionately affected population…

Next ACIP Meetings
No registration is required to watch the webcast.
:: September 22, 2021, 10:00 a.m. – 5:00 p.m. and September 23, 2021, 11:00 a.m. – 2:00 p.m.  is a virtual COVID-19 meeting at https://video.ibm.com/channel/VWBXKBR8af4
No Agenda posted at inquiry.

:: September 29, 2021, 10:00 a.m. – 5:30 p.m. virtual meeting at https://video.ibm.com/channel/VWBXKBR8af4
Agenda draft: https://www.cdc.gov/vaccines/acip/meetings/downloads/agenda-archive/Draft_Meeting-Agenda_Sept-29-2021_for-posting-508.pdf

MMWR News Synopsis Friday, September 17, 2021
:: Disaggregating Data to Measure Racial Disparities in COVID-19 Outcomes and Guide Community Response — Hawaii, March 1, 2020–February 28, 2021
:: Longitudinal Trends in Body Mass Index Before and During the COVID-19 Pandemic Among Persons Aged 2–19 Years — United States, 2018–2020
:: Monitoring Incidence of COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination Status — 13 U.S. Jurisdictions, April 4–July 17, 2021
:: Interim Estimates of COVID-19 Vaccine Effectiveness Against COVID-19–Associated Emergency Department or Urgent Care Clinic Encounters and Hospitalizations Among Adults During SARS-CoV-2 B.1.617.2 (Delta) Variant Predominance — Nine States, June–August 2021
:: Effectiveness of COVID-19 mRNA Vaccines Against COVID-19–Associated Hospitalization — Five Veterans Affairs Medical Centers, United States, February 1–August 6, 2021
:: New COVID-19 Cases and Hospitalizations Among Adults, by Vaccination Status — New York, May 3–July 25, 2021

Coronavirus Disease 2019 (COVID-19)– CDC
Approximately 25 announcements/reports/data summaries.
:: EARLY RELEASE: Comparative Effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) Vaccines in Preventing COVID-19 Hospitalizations Among Adults Without Immunocompromising Conditions — United States, March–August 2021
9/17/2021

Africa CDC [to 18 Sep 2021]

Africa CDC [to 18 Sep 2021]
http://www.africacdc.org/
News
Press Releases
African Union and EDCTP sign Memorandum of Understanding to promote new paradigm in health
ADDIS ABABA, ETHIOPIA, and THE HAGUE, THE NETHERLANDS, September 14, 2021 – The African Union (AU) through the African Centres for Disease Control and Prevention (Africa CDC), and the European and Developing Countries Clinical Trials Partnership (EDCTP) have signed a Memorandum of Understanding (MoU) aimed at establishing a framework to serve as a firm basis for cooperation in their shared goals to promote a new paradigm in health.
Through the MoU, the Africa CDC and EDCTP express their commitment towards joining efforts and maintaining a close and continuous relationship for the achievement of their common objectives. The scope of the MoU is defined through the following themes: Emerging and re-emerging infectious diseases, epidemic intelligence and capacity building for preparedness and outbreak response. The MoU also covers implementation and public health research, the one health approach, and data management. AU and EDCTP will cooperate to implement a programme of work for the execution of activities within these themes.
“The COVID‐19 pandemic represents an unprecedented challenge to health systems, the economy and society across Africa. The partnership between Africa CDC and EDCTP will allow African Union Member States to build back better and stronger from the pandemic. It will take Member States a step closer to a strong and resilient health systems that can prevent, detect, and efficiently respond to infectious disease threats, wherever and whenever they may occur on the continent.” Dr John Nkengasong, Director of Africa CDC…

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

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

National Health Commission of the People’s Republic of China [to 18 Sep 2021]
http://en.nhc.gov.cn/
News
Sept 18: Daily briefing on novel coronavirus cases in China
On Sept 17, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 46 new cases of confirmed infections.

China surpasses 1 billion fully vaccinated
2021-09-17

China’s Chongqing to vaccinate foreign minors against COVID-19
2021-09-17
HONGQING — Southwest China’s Chongqing Municipality will administer COVID-19 vaccines to foreigners aged 12 to 17 from Saturday on a voluntary basis, according to the Chongqing Foreign Affairs Office.
Foreign citizens who are covered by the local health insurance program will enjoy the same policy as insured Chinese people, and those not covered will be charged 100 yuan (about 15.5 U.S. dollars) per dose.
The vaccines are domestically-developed inactivated COVID-19 vaccines, and a total of one or two doses may be required subject to different vaccines…

National Medical Products Administration – PRC [to 18 Sep 2021]
http://english.nmpa.gov.cn/news.html
News
Over 2.16b doses of COVID-19 vaccines administered in China
2021-09-18
More than 2.16 billion doses of COVID-19 vaccines had been administered in China as of Thursday, data from the National Health Commission showed on Sept 17.

Premier Li stresses professional ethics among medical workers
2021-09-15
Premier Li Keqiang, also a member of the Standing Committee of the Political Bureau of the Communist Party of China Central Committee, presided over a medical expert symposium and listened to the attendees’ opinions and suggestions on the development and innovation of medical and health services during a visit to the Peking Union Medical College Hospital on Sept 13.

CCDC Weekly – Weekly Reports: Current Volume (3)
2021-09-17 / No. 38
PDF of this issue
:: Preplanned Studies: Outbreaks of Acute Respiratory Disease Associated with Human Adenovirus Infection in Closed Camps, China, December 2011–March 2014
:: Preplanned Studies: Malaria Surveillance of Entry People During the COVID-19 Epidemic — Guangdong Province, China, October 2020–May 2021
:: Preplanned Studies: Identifying the Key Nodes of HIV Molecular Transmission Network Among Men Who Have Sex with Men — Guangzhou, Guangdong Province, China, 2015–2017
:: Notes from the Field: Two Confirmed Patients of Anthrax — Binzhou City, Shandong Province, China, August 2021
:: Notes from the Field: HIV-2 Seroepidemiological Evidence in Hunan Province — China, 2003–2020

Organization Announcements

::::::

 

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

Paul G. Allen Frontiers Group [to 18 Sep 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

BARDA – U.S. Department of HHS [to 18 Sep 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
News
No new digest content identified.

BMGF – Gates Foundation [to 18 Sep 2021]
https://www.gatesfoundation.org/ideas/media-center
Press Releases and Statements
Gates Foundation’s Annual Goalkeepers Report Finds Stark Disparities in COVID-19 Impacts
New data reveals world stepped up to prevent worst-case scenarios from happening; spotlights need for long-term investments to ensure an equitable recovery and continued progress toward the Global Goals
SEATTLE (September 13, 2021) — The Bill & Melinda Gates Foundation today launched its fifth annual Goalkeepers Report, featuring an updated global dataset illustrating the pandemic’s adverse impact on progress toward the United Nations Sustainable Development Goals (Global Goals).
This year’s report, co-authored by Bill Gates and Melinda French Gates, co-chairs of the Bill & Melinda Gates Foundation, shows that disparities caused by COVID-19 remain stark, and those who have been hardest hit by the pandemic will be the slowest to recover. Because of COVID-19, an additional 31 million people were pushed into extreme poverty in 2020 compared to 2019. And while 90% of advanced economies will regain pre-pandemic per capita income levels by next year, only a third of low- and middle-income economies are expected to do so…

Bill & Melinda Gates Medical Research Institute [to 18 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 18 Sep 2021]
https://carb-x.org/
News
No new digest content identified.

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 18 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 18 Sep 2021]
http://cepi.net/
Latest News
Two expert health leaders join CEPI Board
September 16, 2021, Oslo, Norway– World-leading health experts Dr. Nísia Trindade Lima and Dr. Juan Pablo Uribe have been appointed to the Board of the Coalition for Epidemic Preparedness Innovations (CEPI), an international organisation working to rapidly advance vaccines against COVID-19 and other emerging infectious diseases, and enable access to these vaccines for people during outbreaks…

DARPA – Defense Advanced Research Projects Agency [to 18 Sep 2021
https://www.darpa.mil/news
News
No new digest content identified.

Duke Global Health Innovation Center [to 18 Sep 2021]
https://dukeghic.org/
Our Blog
No new digest content identified.

EDCTP [to 18 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
News
14 September 2021
African Union and EDCTP sign Memorandum of Understanding to promote new paradigm in health
The African Union (AU) through the African Centres for Disease Control and Prevention (Africa CDC), and the European and Developing Countries Clinical Trials Partnership (EDCTP) have signed a Memorandum of Understanding (MoU) aimed at establishing a framework to serve as a firm basis for cooperation in their shared goals to promote a new paradigm in health.
Through the MoU, the Africa CDC and EDCTP express their commitment towards joining efforts and maintaining a close and continuous relationship for the achievement of their common objectives. The scope of the MoU is defined through the following themes: Emerging and re-emerging infectious diseases, epidemic intelligence and capacity building for preparedness and outbreak response. The MoU also covers implementation and public health research, the one health approach, and data management. AU and EDCTP will cooperate to implement a programme of work for the execution of activities within these themes…

Emory Vaccine Center [to 18 Sep 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Vaccine Initiative [to 18 Sep 2021]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

Fondation Merieux [to 18 Sep 2021]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

Gavi [to 18 Sep 2021]
https://www.gavi.org/
13 September 2021
Iraq receives first doses donated by Italy through COVAX

GHIT Fund [to 18 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 18 Sep 2021]
https://www.theglobalfund.org/en/news/
News & Stories
News
No new digest content identified.

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 18 Sep 2021]
https://www.glopid-r.org/news/
No new digest content identified.

Hilleman Laboratories [to 18 Sep 2021]
http://www.hillemanlabs.org/
Website reports “under maintenance” at inquiry

Human Vaccines Project [to 18 Sep 2021]
http://www.humanvaccinesproject.org/
News
HVP COVID Report
Sep 16, 2021
Flor Munoz: What is Driving a Surge in COVID Cases Among Children?

IAVI [to 18 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 18 Sep 2021]
https://www.icrc.org/en/whats-new
Selected News Releases, Statements, Reports
President Peter Maurer addresses the High-level Ministerial Meeting on the Humanitarian Situation in Afghanistan
Secretary-General Guterres, Excellencies,I have just returned from Afghanistan, where I met with the Taliban leadership and visited ICRC’s humanitarian operations, which have continued largely uninterrupted. Across the country, the magnitude of need i
13-09-2021 | Statement

 

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

IFRC [to 18 Sep 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
More than 139 million people hit by climate crisis and COVID-19, new IFRC analysis reveals
13/09/2021

 

WHO/Europe and IFRC sign Memorandum of Understanding to help countries achieve health for all
13/09/2021

Institut Pasteur [to 18 Sep 2021]
https://www.pasteur.fr/en/press-area
Press Documents
No new digest content identified.

IOM / International Organization for Migration [to 18 Sep 2021]
http://www.iom.int/press-room/press-releases
News – Selected
No new digest content identified.

ISC / International Science Council [to 18 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
Blog
How can we communicate science in a more inclusive and accessible manner?
17.09.2021
As part of the continuous workshop series by and for the ISC Science Communications Network, we gathered for an interactive session to discuss best practices in accessible and inclusive science communication. Watch the recordings, download the slides, and connect with the speakers…

IVAC [to 18 Sep 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

IVI [to 18 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 18 Sep 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
New Local Research Reports Released on Carrying Equity in COVID-19 Vaccination Forward
September 15, 2021
The CommuniVax Coalition, which is led by the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health and the Department of Anthropology at Texas State University, released 4 new local reports that share findings from local rapid research within Black and Hispanic/Latino communities in Alabama, California, Idaho, and Maryland.
The new reports, produced by the local CommuniVax teams, highlight the urgent need to humanize delivery and communication strategies for COVID-19 vaccines, develop better and heterogenous messaging, and anchor COVID-19 vaccination efforts in hard-hit communities in a holistic “whole person” recovery process…

MSF/Médecins Sans Frontières [to 18 Sep 2021]
http://www.msf.org/
Latest [Selected Announcements]
Coronavirus COVID-19 pandemic
European Union: more empty promises about global COVID-19 vaccine equity
Project Update 15 Sep 2021

Niger
Combating malaria through water treatment for communities in Niger
Project Update 14 Sep 2021
… “The EU likes to portray itself as a champion of vaccine equity,” says Dr Christos Christou, president of Médecins Sans Frontières. “But the gap between those beautiful words and its actions is embarrassingly wide…

National Academy of Medicine – USA [to 18 Sep 2021]
https://nam.edu/programs/
Selected News/Programs
Risa Lavizzo-Mourey Receives Lienhard Award; Spero M. Manson Receives Sarnat Prize
September 15, 2021
Risa Lavizzo-Mourey Receives Lienhard Award From National Academy of Medicine for Leadership to Improve the Health of All Americans   The National Academy of Medicine today announced Risa Lavizzo-Mourey is the recipient of the 2021 Gustav O. Lienhard Award for Advancement of Health Care for her unwavering efforts to improve the health of all Americans by […]

New Discussion Paper Urges Health Care Quality and Safety Initiatives to Center Health Equity
September 15, 2021
A new individually authored discussion paper in NAM Perspectives — the digital periodical of the National Academy of Medicine — published September 15, 2021 identifies health equity as the area of most urgent and cross-cutting concern for health care quality organizations and outlines a proposed agenda for centering equity in efforts moving forward. On the […]

National Academy of Medicine Announces 10 Emerging Leaders in Health and Medicine
September 14, 2021
The National Academy of Medicine (NAM) today announced the 2021 Emerging Leaders in Health and Medicine Scholars. These individuals are early- to mid-career professionals from a wide range of health-related fields, from emergency medicine and health economics to biomedical engineering and research and public health policy. The scholars are an essential part of a major […]

National Academy of Sciences – USA [to 18 Sep 2021]
http://www.nasonline.org/news-and-multimedia/
News
No new digest content identified.

National Vaccine Program Office – U.S. HHS [to 18 Sep 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

NIH [to 18 Sep 2021]
http://www.nih.gov/news-events/news-releases
News Releases
NIH builds large nationwide study population of tens of thousands to support research on long-term effects of COVID-19
September 15, 2021 — NIH launched the RECOVER Initiative to learn why some people have prolonged symptoms or develop new or returning symptoms after the acute phase of infection from SARS-CoV-2.

PATH [to 18 Sep 2021]
https://www.path.org/media-center/
Press Releases
Levis Nderitu joins PATH as first Global Diversity, Equity and Inclusion Director
September 12, 2021 by PATH
PATH is happy to announce that Levis Nderitu is joining PATH as Director, Global Diversity, Equity, and Inclusion. Based in Nairobi, Kenya, Levis will refine the DEI Strategy PATH launched earlier this year and create a DEI center of expertise to advise, support, and bring together global workstreams.
Levis has over 10 years of international development and private sector experience in DEI, culture, and employee engagement across East Africa, Europe, and the United States. Most recently his work at Médecins Sans Frontières in Kenya has included developing a DEI vision and roadmap, serving as an advisor to leadership, facilitating difficult conversations, and training on cross-cultural competence, unconscious bias, and anti-racism…

Sabin Vaccine Institute [to 18 Sep 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

UNAIDS [to 18 Sep 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
17 September 2021
Forty years of campaigning for equal access to life-saving medicines

15 September 2021
Community-led projects reach vulnerable populations in Latin America and the Caribbean

14 September 2021
More than 140 former heads of state and Nobel laureates call on candidates for German chancellor to waive intellectual property rules for COVID vaccines

14 September 2021
Community-based organizations call for scaled up Internet-based HIV prevention services in China

13 September 2021
Decline in new HIV infections has stalled

UNHCR Office of the United Nations High Commissioner for Refugees [to 18 Sep 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected News Releases, Announcements
UNHCR warns of dire consequences for refugees from COVID-19 underfunding
17 September 2021   |
[See Milestones above for detail]

UNICEF [to 18 Sep 2021]
https://www.unicef.org/media/press-releases
Press Releases, News Notes, Statements [Selected]
Press release
09/17/2021
Schoolchildren worldwide have lost 1.8 trillion hours and counting of in-person learning due to COVID-19 lockdowns, says UNICEF
Urging governments to reopen schools as soon as possible, UNICEF unveils No Time to Lose – a clock counting hours of lost learning – as the UN General Assembly gets underway in NY

Press release
09/15/2021
Indonesia: After 18 months of school closures, children must safely resume face-to-face learning as soon as possible – UNICEF/WHO
Students and teachers will need a full range of support to help catch up on lost learning

Press release
09/14/2021
One month after Haiti earthquake: 260,000 children still need humanitarian assistance – UNICEF

Unitaid [to 18 Sep 2021]
https://unitaid.org/
Featured News
15 September 2021
A new initiative will deliver enhanced malaria prevention to children under two across Africa through a WHO-recommended but under-implemented intervention

15 September 2021
Community health workers bring malaria prevention to pregnant women across Africa, and build new entry points to vital services

13 September 2021
Unitaid, the Clinton Health Access Initiative, and Laurus Labs announce agreement to accelerate development of best-in-class second- and third-line HIV medication for children

Vaccine Equity Cooperative [nee Initiative] [to 18 Sep 2021]
https://vaccineequitycooperative.org/news/
News
Sep 14, 2021
Media: Community-led efforts are the key to ending this pandemic
This article by Advisory Group member Dr. Alexandre White outlines how community-led responses to vaccination and health care delivery are the solution to the ongoing issues of COVID-19 vaccine access and hesitancy – and

Vaccination Acceptance & Demand Initiative [Sabin) [to 18 Sep 2021]
https://www.vaccineacceptance.org/
Announcements
No new digest content identified.

Vaccine Confidence Project [to 18 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 18 Sep 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

Wellcome Trust [to 18 Sep 2021]
https://wellcome.ac.uk/news
News and reports
Explainer
Author Josie Golding
How the response to Ebola outbreaks shows why we need to prioritise preparedness
16 September 2021

Explainer
How science is combatting infectious disease
15 September 2021

Explainer
The cost of not preparing for infectious diseases
12 September 2021

The Wistar Institute [to 18 Sep 2021]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

WFPHA: World Federation of Public Health Associations [to 18 Sep 2021]
https://www.wfpha.org/
Latest News
In Solidarity with Afghanistan
Sep 14, 2021
Afghanistan is suffering a double burden of disease because communicable diseases are widely prevalent throughout the country and non-communicable diseases are also on the rise. Considering the recent changes in…

World Bank [to 18 Sep 2021]
http://www.worldbank.org/en/news/all
Selected News, Announcements
Infographic: A Policy Package to Promote Literacy for All Children
Date: September 17, 2021 Type: Infographic

World Bank Group to Discontinue Doing Business Report 
WASHINGTON, September 16, 2021—The World Bank Group today issued the following statement on the Doing Business report:
“Trust in the research of the World Bank Group is vital. World Bank Group research informs the actions of policymakers, helps countries make better-informed decisions, and allows stakeholders to measure economic and social improvements more accurately. Such research has also been a valuable tool for the private sector, civil society, academia, journalists, and others, broadening understanding of global issues.
“After data irregularities on Doing Business 2018 and 2020 were reported internally in June 2020, World Bank management paused the next Doing Business report and initiated a series of reviews and audits of the report and its methodology. In addition, because the internal reports raised ethical matters, including the conduct of former Board officials as well as current and/or former Bank staff, management reported the allegations to the Bank’s appropriate internal accountability mechanisms.
“ After reviewing all the information available to date on Doing Business, including the findings of past reviews, audits, and the report the Bank released today on behalf of the Board of Executive Directors, World Bank Group management has taken the decision to discontinue the Doing Business report. The World Bank Group remains firmly committed to advancing the role of the private sector in development and providing support to governments to design the regulatory environment that supports this. Going forward, we will be working on a new approach to assessing the business and investment climate. We are deeply grateful to the efforts of the many staff members who have worked diligently to advance the business climate agenda, and we look forward to harnessing their energies and abilities in new ways.”

Statement on Release of Investigation into Data Irregularities in Doing Business 2018 and 2020
WASHINGTON, September 16, 2021— WASHINGTON, September 16, 2021—The World Bank Group today released the following statement on behalf of the Bank’s Board of Executive Directors:
“The World Bank’s Board of Executive Directors today authorized the release of “Investigation of Data Irregularities in Doing Business 2018 and Doing Business 2020 – Investigation Findings and Report to the Board of Executive Directors,” an independent external review of the facts and circumstances around previously reported data irregularities in the 2018 and 2020 Doing Business reports.”
Date: September 16, 2021 Type: Statement
[See Milestones above for detail]

International Organizations, Manufacturers Agree to Intensify Cooperation to Deliver COVID-19 Vaccines
Fourth Meeting of the Multilateral Leaders Task Force on Scaling COVID-19 Tools WASHINGTON, 16 September 2021—The heads of the International Monetary Fund, World Bank Group, World Health Organization and…
Date: September 16, 2021 Type: Statement

Climate Change Could Force 216 Million People to Migrate Within Their Own Countries by 2050
Decisive collective action could reduce climate migration by as much as 80 percent WASHINGTON, Sept. 13, 2021—The World Bank’s updated Groundswell report released today finds that climate change, an increasingly…
Date: September 13, 2021 Type: Press Release

World Customs Organization – WCO [to 18 Sep 2021]
http://www.wcoomd.org/
Latest News – Selected Items
17 September 2021
WCO addresses the Annual Meeting of International Organizations on “Facing Global Crises Together”
On 13 and 14 September 2021, the Organisation for Economic Co-operation and Development (OECD) and the United Nations Commission on International Trade Law (UNCITRAL) hosted online the 8th Annual Meeting of the Partnership for International Organisations.  The event brought together 23 Leaders of International Organizations (IOs), including the WCO, represented by its Secretary General, Dr. Kunio Mikuriya, as well as government, academia and civil society representatives to discuss the theme of “Facing Global Crises for Better International Rulemaking” in view of helping governments strengthen, share and improve the international rules that frame our economies, societies and environment…

16 September 2021
The WCO kicks off regional consultations on the next Strategic Plan

World Organisation for Animal Health (OIE) [to 18 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 18 Sep 2021]
http://www.wto.org/english/news_e/news_e.htm
WTO News and Events
The fourth South-South Dialogue on LDCs and Development: Reinforcing the multilateral trading system for development
17 September 2021
Keynote address by DG Okonjo-Iweala
Speech

 

DG Okonjo-Iweala calls on WTO members to deliver tangible outcomes for LDCs at MC12
17 September 2021
Delivering results at the 12th Ministerial Conference (MC12) to enable least-developed countries (LDCs) to become more resilient and more integrated into the global economy is critical for meeting sustainable development goals, Director-General Ngozi Okonjo-Iweala told Geneva-based ambassadors from LDCs on 16-17 September in Montreux, Switzerland. DG Okonjo-Iweala was speaking at the South-South Dialogue on LDCs and Development sponsored by China.

 

International organizations, vaccine manufacturers agree to intensify cooperation to deliver COVID-19 vaccines
16 September 2021
The heads of the International Monetary Fund, World Bank Group, World Health Organization and World Trade Organization met with the CEOs of leading vaccine manufacturing companies to discuss strategies to improve access to COVID-19 vaccines, especially in low— and lower middle-income countries and in Africa. The Task Force expressed concerns that without urgent steps the world is unlikely to achieve the end-2021 target of vaccinating at least 40% of the population in all countries — a critical milestone to end the pandemic and for global economic recovery
[See Milestones above for detail]

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ARM [Alliance for Regenerative Medicine] [to 18 Sep 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Selected Press Releases
No new digest content identified.

BIO [to 18 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 18 Sep 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

ICBA – International Council of Biotechnology Associations [to 18 Sep 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

IFPMA [to 18 Sep 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Meet Africa’s New Generation of Health Innovators
16 September 2021

IFPMA and Speak Up Africa announce winners of Africa Young Innovators for Health Award
13 September 2021

Report of the Pan-European Commission on Health and Sustainable Development at the WHO EURO 71st
13 September 2021
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) are pleased to contribute this statement to the 71st WHO Regional Committee meeting for Europe. EFPIA and IFPMA represent Europe’s and the world’s leading research-based biopharmaceutical companies, as well as national and regional industry associations, respectively.

COVID-19 has had profound health, social, and economic impacts across Europe and around the world. Coordinated, inclusive, and multi-stakeholder action is the only possible solution to mitigate the devastating consequences of this unprecedented global health emergency.

Innovative health industries remain at the forefront of the global effort to develop and manufacture tests, therapeutics, and vaccines to contain and defeat COVID-19. The existing IP framework has enabled the pharmaceutical industry to respond swiftly to the global crisis and develop several new vaccines with remarkable speed, by engaging in new collaborations to leverage both new approaches and existing molecules.

After more than 200 clinical trials and nearly 300 partnerships and collaborations among manufacturers worldwide, COVID-19 vaccine production has increased exponentially from zero to 5.8 billion doses by the end of August, 20% of which produced in Europe. In Europe 543,129,344 doses have been administered to citizens, equating to around 70% of the population. Globally, the industry is on target to deliver an astounding estimate of 12 billion doses by the end of 2021 – enough doses to vaccinate the world’s adult population. That said, COVID-19 vaccines are not equally reaching all priority populations worldwide. Access to COVID-19 related health products is a collective responsibility that calls for global solidarity and coordinated and collaborative action by public and private actors alike.
The innovative vaccine manufacturers and biotech companies have supported fair and equitable access to vaccines from the outset of the pandemic, as full and active partners in the ACT-Accelerator.

In this spirit, these companies represented by seven industry bodies, announced in May 2021 the “Five steps to urgently advance COVID-19 vaccine equity.” They commit to working with governments and non-governmental organizations including COVAX, CEPI, and WTO to support stepping up dose sharing, continue efforts to optimize production, call out trade barriers to be eliminated, support country readiness, and continue driving innovation.

Looking to the future, it is important that the world uses the lessons we have learned during the COVID-19 crisis to make sure we are all better prepared and have the capacity to respond to emergent health threats. With the creation of a European Health Emergency and Preparedness Response Authority (HERA), Europe is stepping in the right direction.

We call upon governments to do their part and ensure adequate resources are dedicated to building strong, resilient, and sustainable healthcare systems, supported by WHO EURO and other multilateral organizations, and that health is valued as an investment to ensure growth and prosperity. This would include strengthening prevention, early detection and interception of disease, implementing integrated and patient-centered care models, utilizing digital health and health data to its full potential, and increasing access to innovation that improves people’s health and enhances the efficiency of health systems. We also urge governments to guarantee immediate and unhindered access to pathogens and associated information regarding any COVID-19 variants to support the development of new vaccines and treatments.

Industry is committed to delivering preparedness solutions and to contributing our expertise to relevant discussions with national, regional, and global public health, diseases control and regulatory agencies, and to contribute to resilient and sustainable health systems in partnership with all stakeholders. We look forward to playing a meaningful role in shaping the future so that we are stronger together for the next health emergency.

 

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

International Alliance of Patients’ Organizations – IAPO [to 18 Sep 2021]
https://www.iapo.org.uk/news/topic/6
Press and media [Selected]
No new digest content identified.

PhRMA [to 18 Sep 2021]
http://www.phrma.org/
Latest News [Selected]
America’s biopharmaceutical companies to Congress: Government “negotiation” is the wrong approach
September 15, 2021
We agree with leaders in Washington that Americans need help with their health care costs, but these dangerous policy experiments are not the answer.
Blog Post

Journal Watch

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

First description of immune complex vasculitis after COVID-19 vaccination with BNT162b2: a case report

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 18 Sep 2021)

 

First description of immune complex vasculitis after COVID-19 vaccination with BNT162b2: a case report
Cases of immune complex vasculitis have been reported following COVID-19 infections; so far none in association with novel mRNA-based COVID-19 vaccination. This case report describes a cutaneous immune complex…
Authors: Victoria Therese Mücke, Viola Knop, Marcus Maximilian Mücke, Falk Ochsendorf and Stefan Zeuzem
Citation: BMC Infectious Diseases 2021 21:958
Content type: Case report
Published on: 16 September 2021

COVID-19 mRNA vaccine and antibody response in lactating women: a prospective cohort study

BMC Pregnancy and Childbirth
http://www.biomedcentral.com/bmcpregnancychildbirth/content
(Accessed 18 Sep 2021)

 

COVID-19 mRNA vaccine and antibody response in lactating women: a prospective cohort study
Immunological protection via breastfeeding is well known. The immunological profile of human milk changes during lactation. No clinical trials have been conducted in lactating women with the newest mRNA vaccin…
Authors: Nadia Charepe, Juliana Gonçalves, A. Margarida Juliano, David G. Lopes, Helena Canhão, Helena Soares and e Fátima Serrano
Citation: BMC Pregnancy and Childbirth 2021 21:632
Content type: Research
Published on: 17 September 2021

Vaccine hesitancy: evidence from an adverse events following immunization database, and the role of cognitive biases

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 18 Sep 2021)

 

Vaccine hesitancy: evidence from an adverse events following immunization database, and the role of cognitive biases
Vaccine hesitancy has been a growing challenge for public health in recent decades. Among factors contributing to vaccine hesitancy, concerns regarding vaccine safety and Adverse Events (AEs) play the leading …
Authors: Hossein Azarpanah, Mohsen Farhadloo, Rustam Vahidov and Louise Pilote
Citation: BMC Public Health 2021 21:1686
Content type: Research
Published on: 16 September 2021

Changes in patients’ outlook, behaviors, and attitudes toward COVID-19 after hospitalization and their experiences of discrimination and harassment

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 18 Sep 2021)

 

Changes in patients’ outlook, behaviors, and attitudes toward COVID-19 after hospitalization and their experiences of discrimination and harassment
This study aims to examine changes in patients’ perspectives and outlooks regarding the disease and their health after hospitalization for COVID-19 and investigate their discrimination and harassment experienc…
Authors: Ken Goda, Tsuneaki Kenzaka, Shinsuke Yahata, Ayako Kumabe, Masahiro Katsurada and Hogara Nishisaki
Citation: BMC Research Notes 2021 14:362
Content type: Research note
Published on: 17 September 2021

The origins of SARS-CoV-2: A critical review

Cell
Sep 16, 2021 Volume 184 Issue 19 p4841-5070
https://www.cell.com/cell/current

 

Reviews
The origins of SARS-CoV-2: A critical review
Edward C. Holmes,et al/
Open Access
A review of the current literature supports a zoonotic origin for SARS-CoV-2 and emphasizes the need to focus on identifying the exact animal host through collaborative and carefully coordinated studies. This will enable the community to understand the roots of the COVID-19 pandemic as well as better prepare us for future pandemics

Emergence of an early SARS-CoV-2 epidemic in the United States

Cell
Sep 16, 2021 Volume 184 Issue 19 p4841-5070
https://www.cell.com/cell/current

 

Articles
Emergence of an early SARS-CoV-2 epidemic in the United States
Mark Zeller,wt al.
Genomic and epidemiological analyses provide a clearer picture of one of the earliest SARS-CoV-2 superspreader events in the United States in accelerating transmission, with a single introduction of the virus being responsible for most cases during this period.

SARS-CoV-2 Monoclonal Antibodies in Children: Ethical Considerations

Clinical Therapeutics
June 2021 Volume 43 Issue 6 p917-1134
http://www.clinicaltherapeutics.com/current

 

Commentaries
SARS-CoV-2 Monoclonal Antibodies in Children: Ethical Considerations
Ian D. Wolfe, Sameer J. Patel
Published online: May 06, 2021
e157-e162
Abstract
The use of monoclonal antibodies in children with certain conditions and at high risk for severe COVID-19 has been approved by the US Food and Drug Administration under the Emergency Use Authorization mechanism of the Federal Food, Drug, and Cosmetic Act. No data on the tolerability or efficacy of these therapies in persons <18 years of age are available; there is risk. Whether they will work is unknown, but they could. A disproportionate number of these children who meet the criteria for treatment with mAbs are from communities of black, Native American, and other race. How should health systems, hospitals, and clinicians balance the tensions between being seen as experimenting with an untested drug as opposed to withholding a potentially life-saving treatment? This article identifies, analyzes, and makes recommendations on the methods by which health systems, hospitals, and individual clinicians can ethically balance these tensions.

Exploration and Ethical Analysis of Open-label Pediatric Vaccine Trials in a Pandemic

Clinical Therapeutics
June 2021 Volume 43 Issue 6 p917-1134
http://www.clinicaltherapeutics.com/current

 

Exploration and Ethical Analysis of Open-label Pediatric Vaccine Trials in a Pandemic
Ian D. Wolfe, Angira Patel, Larry K. Kociolek, Asma Fazal, Ravi Jhaveri, John D. Lantos
Published online: May 23, 2021
e163-e172
Abstract
Young children will ultimately need to be vaccinated to stop the spread of coronavirus disease 2019 (COVID-19). Initial studies of vaccine were performed in adults. Randomized controlled trials are the gold standard. In the COVID-19 pandemic, many questions need to be answered about the ethics and feasibility of these trials. Given the harms of the COVID-19 pandemic and the now-known efficacy of the vaccines in adults and teens, the question of whether clinical equipoise exists for a placebo-controlled trial of vaccines in younger children remains. Parents may be reluctant to enroll children in these trials because they want their child to receive the vaccine or because they are worried about vaccines or clinical trials in general. One option for gathering data on tolerability and efficacy in children would be to use a nonrandomized trial to enroll parents willing to vaccinate their children and those who are hesitant. We discuss the advantages and disadvantages of such an open-label trial that could provide guidance for future pandemics.

Sanctioned countries in the global COVID-19 vaccination campaign: the forgotten 70%

Conflict and Health
http://www.conflictandhealth.com/
[Accessed 18 Sep 2021]

 

Sanctioned countries in the global COVID-19 vaccination campaign: the forgotten 70%
Authors: Karl Blanchet, Grégoire Mallard, Erica Moret and Jin Sun
Content type: Commentary
17 September 2021
Abstract
COVAX, the global initiative on COVID-19 vaccines, has set the target of achieving a COVID-19 vaccination coverage of up to 30% of the population of 135 countries in 2 years. Here, we argue that COVAX should anticipate important and unforeseen challenges with regard to sanctioned countries. For those, COVAX needs to provide a higher percentage of the vaccines. Otherwise, the problems of vaccination will linger, risking the advent of new variants and preventing an effective global response in reigning the pandemic under control.

The viral era: New biotechnologies give humans an unprecedented control over Nature and require appropriate safeguards

EMBO Reports
Volume 22 Issue 9 6 September 2021
https://www.embopress.org/toc/14693178/current

 

Science & Society 4 August 2021 Open Access
The viral era: New biotechnologies give humans an unprecedented control over Nature and require appropriate safeguards
Bernd Giese
New biotechnologies such as gene drives and engineered viruses herald a viral era that would give humans exceptional power over any organism at the level of the genotype.

A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid-19 Era

Ethics & Human Research
Volume 43, Issue 5 Pages: 1-44 September–October 2021
https://onlinelibrary.wiley.com/toc/25782363/current

 

Commentary
Free Access
A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid-19 Era
Leonardo Tamariz, Fred J. Hendler, John M. Wells, Annette Anderson, Stephen Bartlett
Pages: 42-44
First Published: 08 September 2021

Ethics & International Affairs

Ethics & International Affairs
Summer 2021 (35.2) August 2021
https://www.ethicsandinternationalaffairs.org/2021/spring-2021-35-1/

 

The editors of Ethics & International Affairs are pleased to present the Summer 2021 issue of the journal! The highlight of this issue is a roundtable organized by Adrian Gallagher on the responsibility to protect in a changing world order. The roundtable contains an introductory essay by Michael Ignatieff and contributions from Adrian Gallagher and Nicholas J. Wheeler; Cristina G. Stefan; Luke Glanville and James Pattison; and Jennifer M. Welsh. Additionally, the issue includes feature articles by Daniele Amoroso and Guglielmo Tamburrini on meaningful human control over weapons systems and Patricia Goff on inclusive trade. It also contains a review essay by Andrea C. Simonelli on climate displacement and justice and book reviews by Reed Bonadonna, Cian O’Driscoll, and Shelley Wilcox.

Equity and Vaccine Allocation: Beyond Ethics in Prioritization to Equitable Production, Distribution, and Consumption

Ethics & International Affairs
Summer 2021 (35.2) August 2021
https://www.ethicsandinternationalaffairs.org/2021/spring-2021-35-1/

 

Equity and Vaccine Allocation: Beyond Ethics in Prioritization to Equitable Production, Distribution, and Consumption
Nicole Hassoun | July 2021
Conclusion
Ethicists interested in equitable international vaccine allocation have traditionally focused on principles for prioritizing patient populations, but to have the greatest health impact—whether one focuses on lives, life years, or something else—we must change the question. We should ask how we can vaccinate everyone most effectively. We need to address the need for adequate manufacturing and distribution systems, health care workers, funding, trust in science, and community engagement. We must rethink how we support research and development and reward pharmaceutical innovation to fairly address the COVID-19 pandemic and many other major global health problems. Doing so will in the long run protect individuals better than merely shifting resources around as several current proposals for equitable allocation suggest. It is also in the best interest of some of the world’s wealthiest countries to help develop basic health systems in countries that lack them and reconsider incentives for new pharmaceutical research and development. We need to foster global solidarity to overcome ongoing pandemics and to prepare for those that will surely come our way. We must do more to ensure that poor countries are not left behind. We should institute basic global health systems and support efforts to research, manufacture, distribute, and help everyone access vaccines and other essential medicines for COVID-19 and other major global health problems.51 Anything less is inequitable.52

Supplement: E-Mental-Health: Exploring the Evidence Base and Stakeholders’ Perspectives on Internet-Based Interventions for the Prevention of Mental Health Conditions

The European Journal of Public Health
SUPPLEMENT – Volume 31, Issue Supplement_1, July 2021
https://academic.oup.com/eurpub/issue/31/Supplement_1

 

Supplement: E-Mental-Health: Exploring the Evidence Base and Stakeholders’ Perspectives on Internet-Based Interventions for the Prevention of Mental Health Conditions
Mental illness represents an enormous personal, social and societal burden for European citizens1 calling for the need to expand existing models of mental healthcare delivery. In Europe, the Internet is a key source of health information,2 and technology-enhanced (psychological) interventions such as Internet- and mobile-delivered applications (‘eHealth’3 and ‘m-Health’4) have become increasingly popular and studied. There is already strong evidence of the efficacy of online interventions for the prevention and treatment of several psychological disorders5,6 and meta-analyses show effect sizes similar to face-to-face interventions.7

Integration of HIV and sexual and reproductive health in the era of anti-retroviral-based prevention: findings from assessments in Kenya, Malawi and Zimbabwe

Gates Open Research
https://gatesopenresearch.org/browse/articles
[Accessed 18 Sep 2021]

 

Research Article metrics AWAITING PEER REVIEW
Integration of HIV and sexual and reproductive health in the era of anti-retroviral-based prevention: findings from assessments in Kenya, Malawi and Zimbabwe [version 1; peer review: awaiting peer review]
Fannie Kachale, Imelda Mahaka, Fatima Mhuriro, Mary Mugambi, Joseph Murungu, Barbra Ncube, Getrude Ncube, Albert Ndwiga, Rose Nyirenda, Violet Otindo, Anna Carter, Megan Dunbar, Janet Fleischman, Jessica Rodrigues, Kate Segal
Peer Reviewers Invited
Funder Bill and Melinda Gates Foundation
PUBLISHED 15 Sep 2021

The Global Fund: why anti-corruption, transparency and accountability matter

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 18 Sep 2021]

 

The Global Fund: why anti-corruption, transparency and accountability matter
Authors: Zhihao Chang, Violet Rusu and Jillian C. Kohler
Content type: Research
18 September 2021
Background
The creation of the Global Fund to Fight AIDS, Tuberculosis and Malaria, also known as the Global Fund, was prompted by the lack of a timely and effective global response, and the need for financing to fight against three devastating diseases: HIV/AIDS, tuberculosis, and malaria. During the formation of the Global Fund, necessary anti-corruption, transparency, and accountability (ACTA) structures were not put in place to prevent fraud and corruption in its grants, which resulted in the misuse of funds by grant recipients and an eventual loss of donor confidence in 2011. The Global Fund has instituted various ACTA mechanisms to address this misuse of funding and the subsequent loss of donor confidence, and this paper seeks to understand these implementations and their impacts over the past decade, in an effort to probe ACTA more deeply.

De-escalation strategies for non-pharmaceutical interventions following infectious disease outbreaks: a rapid review and a proposed dynamic de-escalation framework

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 18 Sep 2021]

 

De-escalation strategies for non-pharmaceutical interventions following infectious disease outbreaks: a rapid review and a proposed dynamic de-escalation framework
Authors: Charbel El Bcheraoui, Sophie Alice Müller, Eleanor C Vaughan, Andreas Jansen, Robert Cook and Johanna Hanefeld
Content type: Research
16 September 2021

The incremental cost of improving immunization coverage in India through the Intensified Mission Indradhanush programme

Health Policy and Planning
Volume 36, Issue 8, October 2021
https://academic.oup.com/heapol/issue/36/8

 

ORIGINAL ARTICLES
The incremental cost of improving immunization coverage in India through the Intensified Mission Indradhanush programme
Susmita Chatterjee, Palash Das, Anita Pinheiro, Pradeep Haldar, Arindam Ray
Health Policy and Planning, Volume 36, Issue 8, October 2021, Pages 1316–1324, https://doi.org/10.1093/heapol/czab053