Vaccines and Global Health: The Week in Review :: 26 June 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

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

Gavi Board strengthens commitment to reaching the most vulnerable through routine immunisation and COVAX :: What does COVAX’s latest supply forecast tell us?

Milestones :: Perspectives :: Research

 

Editor’s Note:
These Gavi announcements represent critical milestones in COVID response and, as such, we present their full text.

Gavi Board strengthens commitment to reaching the most vulnerable through routine immunisation and COVAX
:: Gavi Board makes key strategic decisions to support Gavi’s 5.0 strategy of leaving no child behind through immunisation; doubles down on ambitious targets for COVAX
:: New market-shaping strategy, alliances with civil society among measures aimed at reducing the number of children receiving no doses of vaccine, by 25% globally – by 2025 
:: US$ 775 million in COVAX delivery funding approved for lower-income economies that are eligible for support through the Gavi COVAX Advance Market Commitment (AMC)
:: José Manuel Barroso: “Protecting the most vulnerable and enabling access to the lifesaving power of vaccines has always been at the heart of Gavi’s mission. As Africa, with the lowest vaccine coverage in the world, and other regions face a renewed surge of the virus, the global community must step up now to help COVAX to meet its ambitious equitable access goals to support these countries.”

Geneva, 25 June 2021 – The Board of Gavi, the Vaccine Alliance has made several decisions to strengthen the organisation’s commitment to protecting the most vulnerable everywhere – through routine immunisation, access to COVID-19 vaccines via the Gavi-hosted COVAX Facility and support for outbreak preparedness and response activities.

In addition to taking decisions relating to Gavi’s strategic direction, the Board united in condemning today’s gross inequity in vaccine delivery and committed itself to redoubling efforts to close the gap.

“Protecting the most vulnerable and enabling equitable access to lifesaving vaccines has always been at the heart of Gavi’s mission,” said José Manuel Barroso, Chair of the Gavi Board. “As Africa, with the lowest vaccine coverage in the world, and other regions face a renewed surge of the virus, we must use all our resourcefulness and innovation to help those most at risk: the global community must step up now to help COVAX to meet its ambitious equitable goals to support these countries.”

 

Supporting COVAX to deliver 
Earlier this week COVAX, the world’s first global procurement facility for pandemic vaccines, released an updated supply forecast demonstrating that, thanks to new agreements with manufacturers and dose-sharing by higher income economies, supplies were expected to reach two billion doses in January 2022 – only a short time later than previous forecasts, despite severe on-going supply delays. According to the forecast, COVAX’s goal of delivering 1.8 billion doses to lower-income economies eligible for donor-supported doses via the Gavi COVAX Advance Market Commitment (COVAX AMC) would be reached in the first quarter of 2022.

In order to help prepare countries for this rapid scale up, the Gavi Board approved new funding of US$ 775 million to support the delivery of COVAX-funded doses in lower-income economies and humanitarian zones over the next two years. Gavi is co-lead of COVAX and hosts the Office of the COVAX Facility. The funding comes in addition to a previously Board-approved envelope of US$ 150 million in delivery support.

The Board also approved an evolution in the model of participation for self-financing participants (SFPs) of the COVAX Facility. Starting in 2022, the model will enable SFPs that rely on the Facility to access doses to continue procuring vaccines through COVAX under revised terms and conditions. The move, based on lessons learned over the past year, will enable simplified operations and reduce financial risks to Gavi and COVAX.

“As the only global solution designed around equitable access to COVID-19 vaccines, we need to continue to adapt the COVAX model as the pandemic evolves,” said Dr Seth Berkley, CEO of Gavi. “The additional delivery support funding will help make sure that COVAX-funded doses are rapidly and efficiently rolled out in lower-income economies. But it will not help us end the acute phase of pandemic alone: to do this, we need governments, manufacturers and multilateral development banks to truly get behind COVAX and get us doses now so we can scale up protecting lives and do so quickly.”

 

Reaching the most vulnerable with routine immunisation
Many decisions at the two-day board meeting concerned Gavi’s new 5.0 strategy.

Guiding the Alliance’s mission over the period 2021–2025, Gavi 5.0’s goal is to “leave no one behind with immunisation”, with a core focus on reaching “zero-dose” children and missed communities, with equity as the organising principle. 

The following decisions are aimed at providing a critical framework for achieving this goal – building on Gavi’s existing strengths, as well as forming new partnerships and evolving key policies:
:: A measurement framework for the work of the Alliance in the next five years. In line with its 5.0 overarching objective of leaving no one behind, Gavi will aim to reduce the number of zero-dose children globally by 25% in 2021–2025. Other indicators include immunising an additional 300 million children and preventing 7-8 million future deaths through Gavi’s support for routine immunisation programmes and vaccination campaigns, while unlocking US$ 80-100 billion in economic benefits.

:: A 2021-2025 Market Shaping Strategy that will foster a sustainable, competitive future supplier base by encouraging healthy demand through a more coordinated and country-centric approach. The strategy will also focus on enabling vaccine product innovations that best meet country needs and that directly contribute to the Gavi 5.0 goals of increasing equitable vaccine coverage and reaching zero-dose children and missed communities.

:: The Civil Society and Community Engagement Approach to ensure effective management, enhanced capacity and efficient funding of Gavi’s engagement with civil society organisations (CSOs). Beyond their comparative advantage in reaching zero-dose children and missed communities, CSOs have key roles to play in helping to ensure immunisation is maintained, restored and strengthened in the context of COVID-19, and that vaccines are introduced in an equitable way.

:: An initial investment of up to US$ 5 million for the Vaccine Innovation Prioritisation Strategy (VIPS) for costs related to short-term (2021–2023) activities to provide guidance for and incentivise development of three innovation priorities, including clarifying the potential demand, defining investment cases and understanding the need for and design of push and pull funding mechanisms, as well as generating evidence of programmatic impact.

:: Yellow Fever diagnostic capacity strengthening initially to create the first commercial test kits for Yellow Fever, which has been accomplished, and support for costs related to the procurement and distribution of laboratory reagents, supplies and equipment which has been extended until the end of 2022. The costs remain within the initially approved envelope of US$ 8.2 million authorised for the 2019–2021 period.

:: An approach to strengthen fiduciary risk assurance and financial management of Gavi grants in the 5.0 strategic period, with associated investment of US$ 139 million for 2022–2025. As Gavi funding will increasingly be channelled through government systems, the investments will be used to help build sustainable financial management capacity of government systems, as well as ensure the continued use of fiduciary risk mitigation mechanisms.

Encompassing both COVAX and Gavi 5.0 is Gavi’s risk appetite statement, which defines the criteria and trade-off considerations that guide the Alliance’s appetite for risk at the mission, strategy and organisational level. Against the backdrop of the ongoing COVID-19 pandemic, the Board approved an approach where the Alliance will seek to find the right balance between successfully delivering on the COVAX mission, where Gavi plays a central role, while minimising risks to Gavi’s core resources and programmes, acknowledging the reality that a higher risk appetite is needed in a pandemic setting.

 

Key departures and appointments
The Board approved a one-year exceptional contract extension for Gavi CEO Dr Seth Berkley to guarantee stable and strong leadership of the Alliance in this critical time and ensure successful implementation of COVAX and Gavi 5.0. The current CEO’s 3rd term will now end in August 2023 and succession planning will be led by Gavi Board Chair.

The Board also welcomed new Board members including Awa Marie Coll Seck, Naguib Kheraj and Bounfeng Phoummalaysith.

In addition, the Board thanked Stephen Zinser and Muhammad Ali Pate as their terms as Board members concluded. Stephen Zinser has been a Gavi Board member since 2014 and has guided Gavi’s transition through two strategic periods. Muhammad Ali Pate began his term as a Board member in July 2019 lending his counsel and extensive experience to support the work of the Alliance. Mr Pate has also been an invaluable member of Market Sensitive Decisions Committee (MSDC) since October 2019.

Finally, the Gavi Board gave a warm send-off to Bill Roedy. Mr Roedy joined Gavi in 2010 as its first envoy. He was appointed to the Board in 2015 and has been Board Vice Chair in 2018–2019. Mr Roedy is recognised as a global health leader who has used his extensive network and experience to champion both Gavi and immunisation.

 

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What does COVAX’s latest supply forecast tell us?
23 June 2021 – by Aurélia Nguyen, Managing Director, Office of the COVAX Facility

COVAX’s latest supply forecast is now published. According to this latest assessment, the vaccines pillar of the ACT-Accelerator will have 1.9 billion doses available for supply by the end of 2021 and, thanks to a number of recently signed advance purchase agreements, now has signed deals in place for a total of 2.8 billion doses in 2021 and 2022, with a further 1.3 billion secured should it need them. This is due in large part to the pledges made by donors to the Gavi COVAX AMC.

The forecast is encouraging given the supply disruptions COVAX and countries with bilateral deals are currently experiencing, as well as the general challenges manufacturers are experiencing as they ramp up supply at historic speed and scale. But what does it mean in the context of COVAX’s stated goal of ending the acute phase of the pandemic? Unsurprisingly, given that it represents the most ambitious roll-out of vaccines in history, the numbers in the document provide some important insights.

 

Short term supply concerns persist
The first observation is that, despite remaining more or less on target for its original year-end goal to make 2 billion doses available to participants, COVAX deliveries will continue to be very lean through July and August. This is a result of a number of well-documented factors, including the diversion of production at the Serum Institute of India (SII), an important early supplier, to meet acute domestic needs, as well as challenges scaling up deliveries across AstraZeneca’s global manufacturing network and fulfilling requirements to enable delivery of the Pfizer vaccine – COVAX’s other two currently active suppliers.

 

Dose sharing is becoming an important immediate-term source of doses
In response to COVAX’s call to countries with excess supply to help alleviate short term supply shortages by sharing doses, a number of donors have now stepped forward. According to the forecast, 515 million doses have been pledged, and they should start becoming available in significant numbers very soon, with 80 million expected by the end of July and a total of 115 million by the end of August. Apart from the period between September and October when 100 million dose donations are expected to come online, supply from countries’ pledges are anticipated to be relatively evenly paced through the year, with around 40-50 million donated doses available each month until the end of December.

 

Absorptive capacity is a very real concern
The reason why COVAX has been urging donors to share doses in the third quarter rather than later in the year is to avoid the possibility of COVAX participants’ health systems becoming too stretched by the volume of deliveries later in the year. COVAX’s partners work closely with countries in the Facility, especially the 92 lower-income economies eligible for support through the Gavi COVAX AMC, to ensure conditions are in place to enable mass vaccination. From September onwards, the forecast projects that a number in the region of 400 million doses will become available every month so it’s critical that sufficient funding is unlocked, where necessary, to help countries prepare for this.

 

COVAX will keep on doing deals
COVAX has currently signed deals for 2.8 billion doses. This is more than enough to fulfil our goal of delivering 1.8 billion doses to AMC economies as well as supplying the approximately 480 million doses ordered by self-financing economies. A key reason COVAX has signed deals and options for more doses is to allow participants that want to receive more doses to procure them through cost-sharing; taking advantage of COVAX’s pricing and access, plus other advantages such as its no-fault compensation scheme, to raise protection rates in their countries further. COVAX’s goal from the beginning has also been to build a portfolio of 10-12 vaccines to ensure suitability for all contexts and to mitigate risks around over-reliance on specific sources in case there are issues related to failure at the R&D stage, regulatory hurdles or supply challenges. Gavi, on behalf of the Facility, also negotiates key flexibilities such as options and potential access to future variant-adapted vaccines to ensure the Facility portfolio can continue to be tailored to participants’ evolving needs. To this end, expect further advance purchase agreements to be announced in the coming weeks and months.

 

Mind the gap (between availability and deliveries)
One important distinction between the supply forecast and COVAX’s delivery tracker, which is hosted by COVAX’s key delivery partner UNICEF, is that the forecast tracks the availability of doses at the manufacturer. With a number of technical, regulatory and legal tasks to be overcome before doses can be released, there is always a delay between doses becoming available and being shipped and delivered to countries. Although COVAX partners work closely with countries, manufacturers and other stakeholders to minimise this gap, the estimated timings shown here reflect the availability of doses at the manufacturer and not in country.

 

The Supply Forecast will continue to evolve
There are a number of other caveats worth noting in the forecast too, all of which relate to the scale and number of moving pieces across COVAX’s unprecedented end-to-end solution. The timing of regulatory approval, for example, can be volatile, especially since it is common that more than one manufacturing site is involved in the supply chain. Likewise local licensing or export controls can and have had an impact on supply schedules. For these reasons as well as the fact that more secured doses are expected to be added to its portfolio, COVAX will aim to keep this forecast updated as regularly as possible through 2021 and beyond. Watch this space

UNHCR calls on states to remove barriers to access to COVID-19 vaccines for refugees

Milestones :: Perspectives :: Research

 

UNHCR calls on states to remove barriers to access to COVID-19 vaccines for refugees
24 June 2021
Four months since the first delivery of COVID-19 vaccines from the COVAX facility, the global initiative to ensure the vaccines’ equitable distribution, UNHCR, the UN Refugee Agency, calls on States to expedite the roll-out of vaccination campaigns and remove barriers that limit access to vaccines for the world’s 82.4 million forcibly displaced people.

UNHCR is monitoring the inclusion of refugees and asylum seekers in COVID-19 vaccination plans and roll-out in 162 countries.

Of the 126 countries with a refugee population of more than 500 people, UNHCR has confirmed that 123 have either explicitly included refugees in their vaccination plans or provided assurances that they will do so. This is also the case for asylum-seekers in 93 out of 96 countries.

Moreover, UNHCR is able to confirm that refugees and asylum-seekers have begun receiving COVID-19 vaccinations in 91 of the 162 countries monitored. UNHCR commends the States that have included these forcibly displaced populations in the vaccine roll-out and urges others to follow their lead.
“Around the world, we have seen an unwavering commitment to not leave refugees behind in COVID-19 vaccination planning,” said Ann Burton, Chief of UNHCR’s Public Health Section. “But barriers to vaccination persist. Stronger efforts are needed to ensure that States’ assurances for refugee inclusion turn into tangible reality.”

To register for or receive vaccinations, some States require identity documents which refugees often do not have. Others have set up online systems that can deter or prevent people without access to the Internet or who are not computer literate from registering for vaccines.

In several countries, vaccination sites are located far from where refugees live, which could deter them from seeking immunization. This is the case particularly in Sub-Saharan Africa, where newly reported COVID-19 cases are on the rise, in contrast to the observable decline in many parts of the world.
Other factors that prevent people from getting vaccinated include the real or perceived cost of the vaccine services, language barriers, as well as lack of information, misinformation and limited opportunities to ask questions, which can lead to vaccine hesitancy.

UNHCR welcomes the efforts of States to overcome these hurdles. Moldova and Serbia prioritized bringing the vaccine to people living in asylum centers, while in Serbia vaccination is completed for refugees living in private accommodation as well. Senegal and Cameroon allowed refugees to register in designated health facilities and city councils in the vicinity of their communities. Portugal introduced a specific registration system for undocumented persons to ensure that no one is excluded from the vaccine roll-out. Meanwhile, in the Democratic Republic of the Congo (DRC) the region’s largest awareness-raising campaign on COVID-19 has reached more than 1.7 million people since the beginning of the pandemic.

UNHCR stands ready to work with all States to ensure at least 20 per cent of refugees are vaccinated by the end of 2021, as per the target set by COVAX. The Agency also urges States with surplus vaccine doses to share them with lower and middle-income countries and to support the COVAX facility.
“Beyond the moral imperative, this is in our collective self-interest,” said Burton. “As long as the pandemic remains out of control somewhere, it is threat for everyone everywhere.”

WHO supporting South African consortium to establish first COVID mRNA vaccine technology transfer hub

Milestones :: Perspectives :: Research

 

WHO supporting South African consortium to establish first COVID mRNA vaccine technology transfer hub
Geneva/Johannesburg/Paris: The World Health Organization (WHO) and its COVAX partners are working with a South African consortium comprising Biovac, Afrigen Biologics and Vaccines, a network of universities and the Africa Centres for Disease Control and Prevention (CDC) to establish its first COVID mRNA vaccine technology transfer hub.

The move follows WHO’s global  call for Expression of Interest (EOI) on 16 April 2021 to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. Over the coming weeks, the partners will negotiate details with the Government of South Africa and public and private partners inside the country and from around the world.

South African President Cyril Ramaphosa said: “The COVID-19 pandemic has revealed the full extent of the vaccine gap between developed and developing economies, and how that gap can severely undermine global health security. This landmark initiative is a major advance in the international effort to build vaccine development and manufacturing capacity that will put Africa on a path to self determination. South Africa welcomes the opportunity to host a vaccine technology transfer hub and to build on the capacity and expertise that already exists on the continent to contribute to this effort.”

“This is great news, particularly for Africa, which has the least access to vaccines,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “COVID-19 has highlighted the importance of local production to address health emergencies, strengthen regional health security and expand sustainable access to health products.”

…Technology transfer hubs are training facilities where the technology is established at industrial scale and clinical development performed. Interested manufacturers from low- and middle-income countries can receive training and any necessary licenses to the technology. WHO and partners will bring in the production know-how, quality control and necessary licenses to a single entity to facilitate a broad and rapid technology transfer to multiple recipients.

The technology transfer hub will benefit from the Medicines Patent Pool’s (MPP’s) vast experience of intellectual property (IP) management and issuing of IP licenses. MPP is also assisting WHO to negotiate with technical partners and supporting in the governance of the hubs…

COVID Vaccines – OCHA:: HDX

Milestones :: Perspectives :: Research

 

COVID Vaccines – OCHA:: HDX

COVID-19 Data Explorer: Global Humanitarian Operations
COVID-19 Vaccine Roll-out
Jun 25, 2021 | COVAX (WHO,GAVI,CEPI), UNDESA, Press Reports | DATA

 

Global COVID-19 Figures: 179M total confirmed cases; 3.9M total confirmed deaths
Global vaccines administered: 2.79B
Number of Countries: 26 [26]
COVAX First Allocations (Number of Doses): 73M [73M]
COVAX Delivered (Number of Doses): 15M [15M]
Other Delivered (Number of Doses): 37M [34M]
Total Delivered (Number of Doses): 52M [49M]
Total Administered (Number of Doses): 46M [41M]

Coronavirus [COVID-19] – WHO Public 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: 18 Jun 2021
Confirmed cases :: 179 686 071 [week ago: 177 108 695]
Confirmed deaths :: 3 899 172 [week ago 3 840 223]
Vaccine doses administered: 2 624 733 776 [week ago: 2 378 482 776]

 

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Weekly operational update on COVID-19 – 22 June 2021
Overview
In this edition of the COVID-19 Weekly Operational Update, highlights of country-level actions and WHO support to countries include:
:: Shipment of medical kits to support essential health services in Afghanistan
:: Risk Communication and Community Engagement training for frontline responders in Kyrgyzstan
:: Support as COVID-19 cases surge in Africa, nearing first wave peak
:: Release of Basic Psychosocial Skills online course for Pacific COVID-19 responders
:: Infodemic management training in the Democratic Republic of the Congo to support COVID-19 vaccine rollout
:: Launch of an updated COVID-19 National Rapid Response Teams Online Learning Programme and mixed modality trainings in Guinea-Bissau
:: Progress on a subset of indicators from the SPRP 2021 Monitoring and Evaluation Framework
:: Updates on WHO’s financing to support countries in SPRP 2021 implementation and provision of critical supplies.
Weekly epidemiological update on COVID-19 – 22 June 2021
Overview
Global numbers of cases and deaths continued to decrease over the past week (14-20 June 2021) with just over 2.5 million new weekly cases and over 64 000 deaths, a 6% and a 12% decrease respectively, compared to the previous week. While the number of cases reported globally now exceeds 177 million, the lowest weekly case incidence since February 2021 was reported last week. Globally, mortality remains high with more than 9000 deaths reported each day over the past week, however, the number of new deaths reported in the past week decreased across all Regions except for the Eastern Mediterranean and the African Regions.
In this edition, a special focus update is provided on SARS-CoV-2 Variants of Interest (VOIs) and Variants of Concern (VOCs) Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), and Delta (B.1.617.2). This includes updates on emerging evidence surrounding the phenotypic characteristics of VOCs (transmissibility, disease severity, risk of reinfection, and impacts on diagnostics and vaccine performance), as well as updates on the geographic distribution of VOCs.
This edition also includes a summary of a Global Consultation on SARS-CoV-2 Variants of Concern and their Impact on Public Health Interventions.

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Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 26 June 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 update posted from 16 June 2021 data below; click on the link above for full scale view]

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

Milestones :: Perspectives :: Research

 

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
La apuesta de Cuba por el desarrollo de vacunas propias contra la Covid19 tiene una experiencia de más de 30 años.
24/06/2021 23:27:18

[google translate: Cuba’s commitment to the development of its own vaccines against Covid19 has an experience of more than 30 years. 06/24/2021 11:27:18 PM]

 

CanSinoBIO
News
CanSinoBIO Announces Approval for Its Group A and Group C Meningococcal Conjugate Vaccine in China
2021-06-23

Clover Biopharmaceuticals – China
News – No new digest announcements identified

 

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

 

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

IMBCAMS, China
Home – No new digest announcements identified

 

Janssen/JNJ
Press Releases – No new digest announcements identified

 

Moderna
Press Releases
June 22, 2021
European Commission Purchases Additional 150 Million Doses of Moderna’s COVID-19 Vaccine for Delivery in 2022

 

Novavax
Press Releases
Novavax Statement on Completion of the National Research Council of Canada Biologics Manufacturing Centre
Jun 22, 2021
The Honourable François-Philippe Champagne, Minister of Innovation, Science and Industry announced today that construction of the new Biologics Manufacturing Centre (BMC) at the National Research Council of Canada’s (NRC)’s Royalmount location in Montréal, Québec has been completed.
The partnership will enable the first manufacturing capabilities in Canada for a COVID-19 vaccine once the facility and NVX-CoV2373, Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine candidate, receive the required Health Canada approvals. Novavax and the NRC are working closely together on technology transfer to establish the step-by-step process of producing NVX-CoV2373 at the BMC…

 

Pfizer
Recent Press Releases – No new digest announcements identified

 

Sanofi Pasteur
Press Releases
June 22 2021 Press releases
Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

 

Serum Institute of India
NEWS & ANNOUNCEMENTS – No corporate announcements identified
[Last media release April 21, 2021]

 

Sinopharm/WIBPBIBP
News – Website not responding at inquiry

 

Sinovac
Press Releases – No new digest announcements identified

 

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

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

 

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GSK
Press releases for media
New GSK to deliver step-change in growth and performance over next ten years driven by high-quality Vaccines and Specialty Medicines portfolio and late-stage pipeline
23 June 2021
Maximising Vaccines and Specialty Medicines
New GSK will prioritise R&D and commercial investment in Vaccines and Specialty Medicines, which are expected to grow to around three-quarters of company sales by 2026. As part of its 2021-26 outlook, Vaccines is expected to grow sales at a high single-digit % CAGR and Specialty Medicines at a double-digit % CAGR.
The company is focused across four core therapeutic areas (TAs): Infectious Diseases, HIV, Oncology and Immunology/Respiratory. In addition, New GSK will remain open to opportunities outside these core TAs where there are scale opportunities rooted in immune science and genetic validation.
Capturing the increasing opportunities now seen across the prevention and treatment of disease offers significant scientific and commercial opportunities for New GSK. At the heart of this is the company’s R&D focus on the science of the immune system, human genetics and advanced technologies; and its world-leading capabilities in vaccine and pharmaceutical development.
The company currently has a pipeline of 20 vaccines and 42 medicines – many of which are potential best or first in class opportunities…

 

SK Biosciences
Press releases
SK bioscience to Sign MOU with Andong and North Gyeongsang Province for Expansion of Factories and Sites
SK invested about 150 billion won in the expansion of existing vaccine manufacturing plants used for mRNA…
2021. 06. 21

Duke – Launch and Scale Speedometer

Milestones :: Perspectives :: Research

 

Duke – Launch and Scale Speedometer

TRACKING COVID-19 VACCINE PURCHASES ACROSS THE GLOBE
[accessed 26 June 2021]

 

17.9 billion doses reserved
Countries have purchased vaccine doses from a wide pool of candidates to cover their populations. So far, confirmed purchases cover 11.9 billion doses, with another 6 billion doses currently under negotiation or reserved as optional expansions of existing deals…

High-income countries hedged their bets while low-income countries were left out
In 2020, many high-income countries hedged their bets by purchasing enough doses to vaccinate their populations several times over, even before any candidates were approved and have continued to procure more doses of approved vaccines in 2021, in an effort to receive doses as quickly as possible. Because of global manufacturing constraints, the direct deals made by high-income (and some middle-income) countries mean that a smaller piece of the pie is available for low- and middle-income countries and for equity-focused partnerships like COVAX in 2021…

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

Milestones :: Perspectives :: Research

 

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

Vaccines and Related Biological Products Advisory Committee
:: No meetings scheduled

 

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White House [U.S.]
Briefing Room – Selected Major COVID Announcements
Remarks by President Biden Highlighting the Importance of Getting Vaccinated and Kicking Off a Community Canvassing Event
June 24, 2021 • Speeches and Remarks

Press Briefing by White House COVID-19 Response Team and Public Health Officials
June 22, 2021 • Press Briefings

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

Milestones :: Perspectives :: Research

 

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

 

European Medicines Agency
News & Press Releases
News: Additional manufacturing site for COVID-19 Vaccine Janssen (new)
CHMP, Last updated: 25/06/2021
… The site, located in Anagni, Italy, is operated by Catalent Anagni SRL. The site will perform finished product manufacturing.
The site is expected to support the continued supply of COVID-19 Vaccine Janssen in the European Union.
This recommendation does not require a European Commission decision and the site can become operational immediately.

 

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 June 2021 (new)
CHMP, Last updated: 25/06/2021

 

News: Two additional manufacturing sites for BioNTech/Pfizer’s COVID-19 vaccine (new)
CHMP, Last updated: 22/06/2021
… One site, located in Reinbek, Germany, is operated by Allergopharma GmbH & Co. KG. The other in Stein, Switzerland, is operated by Novartis Pharma. The sites will perform finished product manufacturing steps at different stages of the process.
The two new sites are expected to support the continued supply of Comirnaty in the European Union.
This recommendation does not require a European Commission decision and the sites can become operational immediately.

 

European Centre for Disease Prevention and Control
https://www.ecdc.europa.eu/en
Latest Updates
News
ECDC statement on the SARS-CoV-2 Delta variant in the EU/EEA
23 Jun 2021
ECDC publishes a threat assessment brief on the implications of the spread of the Delta variant of concern for the EU/EEA.
Dr. Andrea Ammon, ECDC Director:
Variants of SARS-CoV-2 are emerging at a significant rate worldwide. ECDC is constantly analysing the characteristics of these variants to rapidly inform public health authorities in the European Union. Some variants can put our efforts to control the pandemic at risk and require immediate actions.

 

Based on available scientific evidence, the Delta variant is more transmissible than other circulating variants and we estimate that by the end of August it will represent 90% of all SARS-CoV-2 viruses circulating in the European Union.

Unfortunately, preliminary data shows that it can also infect individuals that have received only one dose of the currently available vaccines. It is very likely that the Delta variant will circulate extensively during the summer, particularly among younger individuals that are not targeted for vaccination. This could cause a risk for the more vulnerable individuals to be infected and experience severe illness and death if they are not fully vaccinated.

The good news is that having received two doses of any of the currently available vaccines provides high protection against this variant and its consequences. However, about 30% of individuals older than 80 years and about 40% of individuals older than 60 years have not yet received a full vaccination course in the European Union.

There are still too many individuals at risk of severe COVID-19 infection whom we need to protect as soon as possible. Until most of the vulnerable individuals are protected, we need to keep the circulation of the Delta virus low by strictly adhering to public health measures, which worked for controlling the impact of other variants.

It is very important to progress with the vaccine roll-out at a very high pace. At this stage it becomes crucial that the second vaccination dose is administered within the minimum authorised interval from the first dose, to speed up the rate at which vulnerable individuals become protected. I am aware that it requires a significant effort from public health authorities and the society at large to achieve this goal. But now is the time to walk the extra mile. We have several safe and effective vaccines available and every single infection prevented now through our compliance with public health measures, is a life that can be saved by vaccination.

 

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

Africa: COVID-19 – Announcements/Regulatory Actions/Deployment

Milestones :: Perspectives :: Research

 

Africa: COVID-19 – Announcements/Regulatory Actions/Deployment

World Bank and African Union Team Up to Support Rapid Vaccination for Up to 400 million People in Africa
Working with countries and partners across Africa to quickly expand equitable access to vaccines
WASHINGTON, June 21, 2021— The African Finance Ministers and the World Bank Group met today to fast track vaccine acquisition on the continent and avoid a third wave. In a boost to the African Union’s target to vaccinate 60% of the continent’s population by 2022, the World Bank and the AU announced that they are partnering to support the Africa Vaccine Acquisition Task Team (AVATT) initiative with resources to allow countries to purchase and deploy vaccines for up to 400 million people across Africa.

This extraordinary regional effort complements COVAX and comes at a time of rising COVID-19 cases in the region. World Bank financing is available to support the purchase and deployment of doses secured by AVATT.

“The World Bank is very pleased to support African countries through this partnership with the African Union to quickly provide hundreds of millions of doses,” said World Bank Group President David Malpass. “Working together, we can expedite doses to countries and support deployment. Countries urgently need more pathways for acquiring vaccines that match their needs and have early delivery schedules.”

“As a result of this joint initiative between the World Bank and African institutions such as the Africa Import Export Bank and the Africa Centre for Disease Control, we now have the capacity to vaccinate at least 400 million people, or 30% of our population of 1.3 billion,” said Strive Masiyiwa, African Union Special Envoy and coordinator of the AVATT. “We really appreciate the extraordinary partnership on this initiative between the AU Vaccine Champion, HE President Cyril Ramaphosa, and David Malpass, the President of the World Bank.”…

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

Milestones :: Perspectives :: Research

 

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

 

Russia: Sputnik V – “the first registered COVID-19 vaccine”
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
Test batch of the Sputnik V vaccine produced in Iran
Press release, 26.06.2021

Single-dose Sputnik Light vaccine registered in Kyrgyzstan
Press release, 25.06.2021

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

Milestones :: Perspectives :: Research

 

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

 

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

22.06.2021
Toolkit for Youth Campaign on COVID Appropriate Behaviour, Vaccination drive and Psychosocial well-being

 

Government of India – Press Information Bureau
Latest Press Releases
PM holds a high level meeting to review progress of vaccination
Posted on: 26 Jun 2021

PM lauds record breaking vaccination numbers
Posted on: 21 Jun 2021

 

Indian Council for Medical Research (ICMR)
https://www.icmr.gov.in/media.html
Press Releases
India achieves milestone of 40 crores COVID-19 Sample Testing : Number of Covid-19 testing laboratories at more than 2600

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

Milestones :: Perspectives :: Research

 

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

NMPA holds meeting to review vaccine regulatory quality management system
2021-06-25
The National Medical Products Administration (NMPA) held a vaccine regulatory quality management system review meeting on June 15, to summarize the construction and operation of the system, evaluate its appropriateness, effectiveness and adequacy, and make arrangements for the key tasks of the next stage of its construction…

China-UK drug regulatory cooperation project kicks off
2021-06-21
The meeting adopted the plan for the China-UK drug regulatory cooperation project in 2021 to push forward technical exchanges in areas of drug review, inspection and post-marketing monitoring for better mutual understanding and deeper cooperation….

POLIO Public Health Emergency of International Concern (PHEIC)

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 22 June 2021

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
:: Pakistan: one WPV1 positive environmental sample
:: Côte d’Ivoire: one cVDPV2 case
:: Nigeria: three cVDPV2 cases
:: South Sudan: two cVDPV2 cases
:: Tajikistan: nine cVDPV2 cases and two cVDPV2 positive environmental samples

 

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

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.”

 

Ebola outbreak, Democratic Republic of the Congo, 2021
[Last apparent update: 3 May 2021]

Ebola outbreak outbreak, N’Zerekore, Guinea, 2021 [Last apparent update: 3 May 2021]

Coronavirus disease (COVID-19) pandemic [Last apparent update 25 June 2021; See COVID above]

Ebola outbreak, Equateur Province, Democratic Republic of the Congo, 2020 [Last apparent update: 1 June 2021]

Ebola outbreak, North Kivu, Ituri, Democratic Republic of the Congo, 2018 – 2020 [Last apparent update: 3 May 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 May 2021]

Somalia crisis [Last apparent update: 9 May 2018]

Nigeria crisis [Last apparent update: 9 May 2018]

Ebola outbreak, Democratic Republic of the Congo, 2017 [Last apparent update: 3 May 2021]

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

Ebola outbreak: West Africa, 2014-2016 [Last apparent update: 3 May 2021]

Iraq crisis [Last apparent update: 9 Jan 2008]

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

Avian influenza A (H7N9) virus outbreak [Last apparent update: 21 May 2021]

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
No new digest content identified

 

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

WHO & Regional Offices [to 26 Jun 2021]

WHO & Regional Offices [to 26 Jun 2021]
https://www.who.int/
25 June 2021
News release
At Local Production Forum, WHO and partners highlight key steps to improve access to health technologies

25 June 2021
Departmental news
WHO releases first-ever global guidance for country validation of viral hepatitis B and C elimination

24 June 2021
Departmental news
Demystifying digital health to improve family planning

24 June 2021
Joint News Release
Directors General of WHO, WIPO and the WTO agree on intensified cooperation in support of access to medical technologies worldwide to tackle the COVID-19 pandemic

24 June 2021
Departmental news
WHO announces the update of the “Consolidated Guidelines on HIV, Hepatitis and STI prevention, diagnosis, treatment and care for key populations”

23 June 2021
Departmental news
Putting people first in managing their health: new WHO guideline on self-care interventions

22 June 2021
News release
UNESCO and WHO urge countries to make every school a health-promoting school

21 June 2021
News release
WHO supporting South African consortium to establish first COVID mRNA vaccine technology transfer hub
[See COVID above for detail]

 

::::::

Weekly Epidemiological Record, Vol. 96, No. 25, pp. 241–264
25 June 2021
:: Review of global influenza circulation, late 2019 to 2020, and the impact of the COVID-19 pandemic on influenza circulation

 

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Leaving a legacy after Ebola in Guinea 21 June 2021
It is a quiet morning at an Ebola treatment centre in the outskirts of N’zerekore, a town in the south-east of Guinea. The centre’s triage and reception areas are all empty, and medical staff are relaxed and jovial as they tend to a small handful of patients or catch up on some administrative tasks in the office.
Read more »
:: Vaccination boosts Sierra Leone’s Ebola prevention 21 June 2021
While the 2014–2016 deadly Ebola outbreak in West Africa devastated lives and wrecked health services, it also offered pivotal lessons in outbreak control by stoking swift and more effective response as well as driving progress in vaccines and therapeutics.
:: Guinea’s Minister of Health explains what it took to end Ebola 21 June 2021

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
No new digest content identified

WHO European Region EURO
No new digest content identified

WHO Eastern Mediterranean Region EMRO
:: Leadership programme on epidemic and pandemic preparedness and response launched 24 June 2021
:: WHO/EU project procures life-saving medicines for children with cancer in Islamic Republic of Iran
22 June 2021
:: Polio vaccination against the odds in Yemen 22 June 2021

WHO Western Pacific Region
No new digest content identified

CDC/ACIP [U.S.] [to 26 Jun 2021]

CDC/ACIP [U.S.] [to 26 Jun 2021]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements

CDC Director Extends the Eviction Moratorium for 30 days
Thursday, June 24, 2021

CDC and HHS Award $200 Million for Disease Intervention Specialist Workforce
Funding awarded to 59 jurisdictions as part of the $1.13 billion investment over the next five years as part of the American Rescue Plan Act of 2021
Monday, June 21, 2021
On June 18, 2021, the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services awarded 59 jurisdictions with $200 million to bolster support and enhance  the disease intervention specialists (DIS) workforce. These awards represent the initial funding of the $1.13 billion investment being made over the next five years, consistent with the American Rescue Plan Act of 2021external icon, and will provide these jurisdiction public health programs and CDC with the support needed to expand and leverage the valuable work of DIS.
“Disease intervention specialists have helped halt infectious disease outbreaks in America for decades, and this funding builds upon that expertise for a stronger, healthier America,” said CDC Director Rochelle P. Walensky, MD, MPH. “This critical investment to recruit and train the experts needed to end this pandemic and prevent the next one is part of our larger effort to rebuild public health infrastructure in the United States to ensure it can protect the health of all Americans for generations to come.”…

MMWR News Synopsis Friday, June 25, 2021

MMWR News Synopsis Friday, June 25, 2021
:: HIV Testing Trends Among Persons with Commercial Insurance or Medicaid — United States, 2014–2019
:: COVID-19 Surveillance and Investigations in Workplaces — Seattle and King County, Washington, June 15–November 15, 2020
:: COVID-19 Vaccination Coverage Among Adults — United States, December 14, 2020–May 22, 2021 (Early Release June 21, 2021)
:: COVID-19 Vaccination Coverage and Intent Among Adults Aged 18–39 Years — United States, March–May 2021 (Early Release June 21, 2021)

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

China CDC http://www.chinacdc.cn/en/
CCDC Weekly – Weekly Reports: Current Volume (3)
2021-06-25 / No. 26
PDF of this issue
:: Preplanned Studies: The Impact of COVID-19 on Tuberculosis Patients’ Behavior of Seeking Medical Care — China, 2020
:: Outbreak Reports: A Tuberculosis Outbreak During the COVID-19 Pandemic — Hubei Province, China, 2020
:: Healthy China: Practical Experiences of Delivering Multidrug-Resistant Tuberculosis Comprehensive Supportive Care Services in China

National Health Commission of the People’s Republic of China [to 26 Jun 2021]
http://en.nhc.gov.cn/
News
June 26: Daily briefing on novel coronavirus cases in China
On June 25, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 25 new cases of confirmed infections.

China committed to facilitating equitable vaccine distribution globally
2021-06-24
BEIJING — Delta, the highly infectious coronavirus variant, has been reported in more than 90 countries and regions across the world, highlighting the urgency to mount a herd immunity defense through mass vaccination.
Some developing countries are left in scarcity of vaccines as certain countries have hoarded COVID-19 vaccines several folds more than the amount needed to vaccinate their populations.
To solve the problems of insufficient production capacity and an unbalanced distribution of COVID-19 vaccines, China has put forward its proposals on multiple international forums.
At the 73rd World Health Assembly in May 2020, China made a solemn commitment to making COVID-19 vaccines a “global public good,” offering its assistance in promoting fair accessibility to vaccines and affordability for developing countries.
At the Global Health Summit in late May, China called for the rejection of vaccine nationalism in a bid to make vaccines more accessible and affordable in the developing world.
China spares no effort to deliver on its promise in championing international cooperation in fighting the pandemic.
Despite a tight supply and huge domestic demand, China has provided over 350 million doses of COVID-19 vaccines for the international community, including vaccine aid provided for over 80 developing countries and those exported to more than 40 countries.
China has also pledged to provide the first batch of 10 million COVID-19 vaccine doses to COVAX, an initiative aimed to promote equitable access to vaccines initiated by the World Health Organization (WHO)…

National Medical Products Administration – PRC [to 26 Jun 2021]
http://english.nmpa.gov.cn/news.html
News
Over 1.1 bln doses of COVID-19 vaccines administered in China
2021-06-25
More than 1.1 billion doses of COVID-19 vaccines have been administered in China as of Thursday, the National Health Commission said on June 25.

NMPA holds meeting to review vaccine regulatory quality management system
2021-06-25
The National Medical Products Administration (NMPA) held a vaccine regulatory quality management system review meeting on June 15, to summarize the construction and operation of the system, evaluate its appropriateness, effectiveness and adequacy, and make arrangements for the key tasks of the next stage of its construction.

China-UK drug regulatory cooperation project kicks off
2021-06-21
The meeting adopted the plan for the China-UK drug regulatory cooperation project in 2021 to push forward technical exchanges in areas of drug review, inspection and post-marketing monitoring for better mutual understanding and deeper cooperation.

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 26 Jun 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
News from The Paul G. Allen Frontiers Group: June 2021
June 23, 2021
Highlights include a new study by the Allen Discovery Center for Human Brain Evolution, a Science in Sixty video featuring Kathryn Richmond, and more.

 

BARDA – U.S. Department of HHS [to 26 Jun 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
News
No new digest content identified.

 

BMGF – Gates Foundation [to 26 Jun 2021]
https://www.gatesfoundation.org/ideas/media-center
Press Releases and Statements
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 26 Jun 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
Jun 10, 2021
Penny Heaton @drpennyheaton
It’s a bittersweet day as I announce my departure from @GatesMRI to join @JanssenGlobal. I’m grateful for the opportunity to have led such an incredible organization – and I’m excited to lead a team transforming global #vaccine development.

 

CARB-X [to 26 Jun 2021]
https://carb-x.org/
News
No new digest content identified.

 

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 26 Jun 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 – June 2021 is now posted here

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 26 Jun 2021]
http://cepi.net/
Latest News
No new digest content identified.

 

CIOMS – COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES [to 26 Jun 2021]
https://cioms.ch/
Publications
CIOMS Cumulative Pharmacovigilance Glossary (Version 1.1)
Year of publication: 2021 Number of pages: 81
PDF: https://cioms.ch/wp-content/uploads/2021/03/CIOMS-Cumulative-Glossary_v1.1_3Jun2021.pdf
This glossary compiles the terms and definitions from published CIOMS pharmacovigilance reports.
We welcome all feedback. Please e-mail your recommendations to info@cioms.ch.

Clinical research in resource-limited settings
CIOMS
ISBN: 978-929036100-8
Year of publication: 2021 Number of pages: 136
PDF: https://cioms.ch/wp-content/uploads/2021/06/CIOMS_ClinicalResearch_RLS.pdf
Description
Evidence generated through responsible clinical research is one of the major pillars of the advancement of health care. In past decades there has been tremendous progress in the clinical research and development (R & D) environment globally, with increasing attention being paid to the health needs of people in resource-limited settings, where most of the preventable morbidity and mortality occurs. However, financial, social, ethical and regulatory challenges persist in low- and middle-income countries (LMICs), and most clinical research today is still being conducted in and for high-income countries (HICs). The aim of this report is to provide balanced arguments to promote scientifically sound good quality clinical research in low-resource settings.
The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization with the mission to advance public health through guidance on health research and policy including ethics, medical product development and safety. This report reflects the consensus opinion of the CIOMS Working Group on Clinical Research in Resource-Limited Settings, and was finalized in line with comments received during public consultation. The report is intended for governments and regulatory authorities, the research community and sponsors, as well as international organizations involved in funding or conducting research. The report provides a comprehensive set of recommendations to all major stakeholders. While it builds on the 2016 CIOMS International Ethical Guidelines for Health-related Research Involving Humans, it is not intended to supersede those guidelines.

 

DARPA – Defense Advanced Research Projects Agency [to 26 Jun 2021
https://www.darpa.mil/news
News
No new digest content identified.

 

Duke Global Health Innovation Center [to 26 Jun 2021]
https://dukeghic.org/
Friday, June 18, 2021
The G7 underwhelms, with numbers that don’t add up
The G7 began their much-anticipated summit last week with a target to reach 1 billion doses of Covid-19 vaccine in pledged donations for low- and middle-inco

 

EDCTP [to 26 Jun 2021]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
No new digest content identified.

 

Emory Vaccine Center [to 26 Jun 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Vaccine Initiative [to 26 Jun 2021]
http://www.euvaccine.eu/
Latest News
EVI signs MoU with CEPI
21 June 2021
The European Vaccine Initiative (EVI), as coordinator of the TRANSVAC2 vaccine research infrastructure, and the Coalition for Epidemic Preparedness Innovations (CEPI) recently signed a Memorandum of Understanding (MoU), laying the foundation to establish a vaccinology training collaboration with the TRANSVAC2 project.
TRANSVAC2 is dedicated to accelerating and improving vaccine development, by strengthening and disseminating European vaccine expertise. As one of the support activities offered to the scientific community, TRANSVAC2 provides training courses surrounding fundamental and advanced knowledge on a wide-range of vaccine development-related topics. With this MoU, we will boost access of advanced vaccine research and development training to CEPI’s team members, thereby directly supporting CEPI´s important mission to accelerate the development of vaccines against emerging infectious diseases.
EVI welcomes this new partnership agreement with CEPI that attests to the high quality and demand of trainings and courses organised by TRANSVAC2 partners, including University of Oxford, Vaccine Formulation Institute, Wageningen University, Biomedical Primate Research Centre (BPRC), The French Alternative Energies and Atomic Energy Commission (CEA), Fraunhofer (IMI-Fraunhofer), University of Siena (UNISI) and EATRIS.

 

FDA [to 26 Jun 2021]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
June 25, 2021 – Coronavirus (COVID-19) Update: June 25, 2021
Today, the FDA is announcing revisions to the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination. For each vaccine, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) has been revised to include a warning about myocarditis and pericarditis and the Fact Sheet for Recipients and Caregivers has been revised to include information about myocarditis and pericarditis. This update follows an extensive review of information and the discussion by CDC’s Advisory Committee on Immunization Practices meeting on Wednesday. The data presented at this meeting reinforced the FDA’s decision to revise the fact sheets and further informed the specific revisions. The warning in the Fact Sheets for Healthcare Providers Administering Vaccines notes that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly following the second dose and with onset of symptoms within a few days after vaccination. Additionally, the Fact Sheets for Recipients and Caregivers for these vaccines note that vaccine recipients should seek medical attention right away if they have chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart after vaccination. The FDA and CDC are monitoring the reports, collecting more information, and will follow-up to assess longer-term outcomes over several months.

June 24, 2021 – Coronavirus (COVID-19) Update: FDA Authorizes Drug for Treatment of COVID-19
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is not authorized for use in outpatients with COVID-19.

June 22, 2021 – Coronavirus (COVID-19) Update: June 22, 2021

 

Fondation Merieux [to 26 Jun 2021]
http://www.fondation-merieux.org/
News, Events
No new digest content identified

 

Gavi [to 26 Jun 2021]
https://www.gavi.org/
News Releases
24 June 2021
Gavi Board strengthens commitment to reaching the most vulnerable through routine immunisation and COVAX
[See COVID above for full text]

23 June 2021
What does COVAX’s latest supply forecast tell us?
[See COVID above for full text]

24 June 2021
Gavi and the Global Fund sign groundbreaking agreement with International Federation of Accountants to support in-country financial management
Geneva, 24 June 2021 – Global health leaders Gavi, the Vaccine Alliance and the Global Fund to Fight AIDS, Tuberculosis and Malaria have joined forces with the International Federation of Accountants (IFAC) to contribute to, and support, the implementation of robust accounting practices in the public health sector and to improve overall financial management of donor funds by implementing countries.
Through this Memorandum of Understanding (MoU), Gavi, the Global Fund and IFAC seek to strengthen the expertise of accountancy and finance professionals and help close the gaps in accountancy skills in implementing countries, which can impact the reliability and effectiveness of managing and disbursing funds. The MoU builds on a 2011 agreement and aims to optimize the joint efforts of global health partners to maximize the performance of investments and support the sustainability of health programs.
“Gavi has cooperated with IFAC and national accounting organizations for a number of years to ensure sound financial management of the funding we provide to countries – this agreement allows us to go much further with a focus on the health sector, in leveraging the expertise of the accountancy profession to boost transparency, build local skills and capacity to improve overall accounting practices, and build a stronger ethical framework,” Anuradha Gupta, Deputy CEO of Gavi, commented. “That will ultimately bring economic and societal benefits to everyone.”
“Equipping our implementing partners with the right financial management skills is essential to maximize the impact of our investments and contributes to greater results in the fight against HIV, tuberculosis and malaria,” said Adda Faye, Chief Financial Officer at the Global Fund. “We are excited to join efforts with Gavi and IFAC to strengthen financial management, reporting, accountability, and transparency to better serve the societies and people in countries receiving Global Fund investments.”
“Robust and transparent accounting and reporting systems are the bedrock of strong public financial management and are thereby critical to the effectiveness and impact of Gavi and The Global Fund’s disbursement of lifesaving funds and resources,” said IFAC President Alan Johnson. “Leveraging our global network and accountancy expertise, this MoU underscores the unique value that IFAC and our member bodies bring to organizations with a shared interest in enhancing the accountancy function to build a resilient and sustainable public health sector that leads to a fairer society for all.”
This work will start with a number of pilot countries in collaboration with local professional accountancy organizations (PAOs). Gavi and the Global Fund will be responsible for funding, selecting beneficiary organizations, and monitoring the implementation of targeted capacity-building activities which include training, establishing and reinforcing accountancy standards, reinforcing ethics and whistle-blowing policies, implementing diversity and inclusiveness policies and helping set up appropriate legal foundations, governance structures, and operational capacity.
Ultimately, this partnership will lead to better integration of Gavi and the Global Fund investments into country systems, better internal controls to reduce fiduciary and financial risks, enhanced absorption of grants and ultimately greater impact.

Gavi allocates US$ 60 million for RBC GAM impact investment bond
:: Gavi is investing in the RBC Global Asset Management’s RBC Impact Bond Strategy, which supports measurable social and environmental progress
:: In recent years, Gavi has substantially expanded its embrace of sustainably focused investments
:: “Our partnership with RBC GAM puts Gavi’s investment resources where its values and mission are,” said Stephen Zinser, the Chair of Gavi’s investment committee
Geneva 21 June 2021 – Gavi, the Vaccine Alliance today announced it is allocating US$ 60 million to support economic development efforts with an aim of reducing poverty, promoting economic prosperity for all and protecting the planet.
In partnership with RBC Global Asset Management (RBC GAM), Gavi is investing in the RBC Impact Bond Strategy, which is dedicated to supporting measurable social and environmental progress through investments in projects like clean water and sanitation, good health and well-being, affordable housing, clean energy, economic equality, and quality education. This investment aims to deliver both competitive risk-adjusted returns and positive social and environmental outcomes.
“Our partnership with RBC GAM puts Gavi’s investment resources where its values and mission are,” said Stephen Zinser, the Chair of Gavi’s investment committee and CEO of Roxbury Asset Management…

 

GHIT Fund [to 26 Jun 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 26 Jun 2021]
https://www.theglobalfund.org/en/news/
News & Stories
News
Gavi And The Global Fund Sign Groundbreaking Agreement With International Federation Of Accountants To Support In-Country Financial Management
24 June 2021
Global health leaders Gavi, the Vaccine Alliance and the Global Fund to Fight AIDS, Tuberculosis and Malaria have joined forces with the International Federation of Accountants (IFAC) to contribute to, and support, the implementation of robust accounting practices in the public health sector and to improve overall financial management of donor funds by implementing countries.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 26 Jun 2021]
https://www.glopid-r.org/news/
News
No new digest content identified.

 

Hilleman Laboratories [to 26 Jun 2021]
http://www.hillemanlabs.org/
Website reports “under maintenance” at inquiry

 

Human Vaccines Project [to 26 Jun 2021]
http://www.humanvaccinesproject.org/
No new digest content identified.

 

IAVI [to 26 Jun 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 26 Jun 2021]
https://www.icrc.org/en/whats-new
Selected News Releases, Statements, Reports
Sexual Violence, Conflict, and COVID-19: An Invisible Pandemic
Despite clear legal prohibitions, sexual violence remains widespread during armed conflicts and other situations of violence, as well as in detention. It occurs in various contexts and has grave humanitarian consequences.
24-06-2021 | Article

The challenges for humanitarian action in today’s conflicts: the perspective from the International Committee of the Red Cross
Excellencies, colleagues.It is a pleasure to address you today and I extend my warm appreciation to Minister of Defence Sergey Shoygu.
23-06-2021 | Statement

 

 

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

 

 

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

 

IFRC [to 26 Jun 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Fiji
Pacific: Vaccination uptake critical as COVID-19 variants spread
Kuala Lumpur/Suva, 23 June 2021 – The International Federation of Red Cross and Red Crescent Societies (IFRC) urges all adults to get vaccinated in Pacific countries including Fiji as it sets grim national records for COVID-19 infections. Fiji is strug …
23 June 2021

Red Cross Red Crescent: Humanitarian sector joins forces to tackle ‘existential threat’ of climate change
Geneva, 22 June 2021 – The humanitarian sector has a key role to play in addressing the climate and environment crises that affect people’s lives and livelihoods around the world every day. This means walking the talk in terms of integrating climate sm …
22 June 2021

Fiji
Fiji TC Yasa: Six months on COVID-19 slows recovery efforts
Kuala Lumpur/Suva, 21 June 2021 – Six months after Cyclone Yasa tore through Fiji, leaving thousands of people homeless, essential movement restrictions to contain the dangerous spread of COVID-19 have delayed recovery efforts. Restrictions, while nece …
21 June 2021

 

Institut Pasteur [to 26 Jun 2021]
https://www.pasteur.fr/en/press-area
Press Info
Press release 22.06.2021
Drug repurposing to counter COVID-19: antiviral activity may be induced by phospholipidosis
Over the past 16 months and against the backdrop of the COVID-19 health crisis, thousands of drugs have been tested with a view to repurpose them to tackle SARS-CoV-2. Many of these drugs have demonstrated potential antiviral activity (23 compounds including hydroxychloroquine, azithromycin, amiodarone and 4 others tested in clinical trials). Given this high number of potential treatments, the University of California San Francisco (UCSF), the Quantitative Biosciences Institute, the Institut Pasteur and Novartis joined forces as part of an international collaboration to demonstrate that in vitro antiviral activity was in fact induced by a mechanism common to all the compounds: phospholipidosis. This research has revealed the importance of systematically testing phospholipidosis as part of the repurposing process, with a view to honing criteria for selecting drugs put forward for clinical trials. The results of the research were published in Science on June 22, 2021…

 

IOM / International Organization for Migration [to 26 Jun 2021]
http://www.iom.int/press-room/press-releases
News
UNAIDS, IOM: People on the Move Living with HIV Must Have Access to COVID-19 Vaccines
2021-06-24 23:51
Geneva – Migrants, refugees, internally displaced as well as crisis-affected and mobile populations who are living with HIV must have equitable access to COVID-19 vaccines, said the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the International Organization for…

UN Agencies Welcome Relocation of 4,000 Vulnerable Asylum Seekers and Refugees from Greece, Encourage Further Steps Towards Predictable, Systematic European Mechanism
2021-06-24 22:36
Athens –  IOM, the International Organization for Migration, UNHCR, the UN Refugee Agency, and UNICEF the UN Children’s Fund welcomed today (24-06) the relocation of 43 asylum seekers on two flights to France.

Nearly 14 Million Internally Displaced Persons, Refugees and Migrants Hit Hard by COVID-19 in East and Horn of Africa, New IOM-WFP Study Finds
2021-06-22 11:59
Nairobi – Nearly 9 million Internally Displaced Persons (IDPs), 4.7 million refugees and asylum-seekers, and hundreds of thousands of migrants in East and Horn of Africa are suffering some of the worst impacts of the COVID-19 pandemic, according to a report from IOM, the…

UN Statement on the Renewal of Humanitarian Lifeline to Millions of People in North-West Syria
2021-06-21 17:42
Rome/Geneva/New York – Millions of people are pressed up against the border in an active war zone in north-west Syria and remain in need of humanitarian aid to survive. The UN needs cross-border and cross-line access to reach those most in need.

 

IVAC [to 26 Jun 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
Webinar: Vaccines, Primary Care, and Public Health—After COVID, What’s Next?
When: Wednesday, July 7, 2021 from 12:00pm to 1:00pm ET
Join Dr. Tom Frieden, President and CEO of Resolve to Save Lives, for a 60-minute webinar hosted by the International Vaccine Access Center to discuss what roles and strategies vaccines, primary care and public health will play while we prepare for life after COVID-19.

 

IVI [to 26 Jun 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

 

JEE Alliance [to 26 Jun 2021]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

Johns Hopkins Center for Health Security [to 26 Jun 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
25 Stakeholder Groups Call on Congressional Leadership to Invest $30 billion over 4 years to Better Protect Americans from Future Pandemics
June 22, 2021 June 22, 2021 – Today, the Johns Hopkins Center for Health Security joined 24 other stakeholder organizations to submit a letter of support to strongly encourage Congressional leaders to invest $30 billion over 4 years to better protect Americans from future pandemics, as called for in the American Jobs Plan. These funds can create new U.S. jobs in public health, science and technology innovation, and domestic medical countermeasures infrastructure.
Given the devastating consequences of the COVID-19 pandemic, the U.S. should aim to achieve an ambitious but achievable goal of creating a pandemic-free future. Together the 25 stakeholder groups strongly encourage Congress to include this $30 billion investment in a funding vehicle this year…

 

MSF/Médecins Sans Frontières [to 26 Jun 2021]
http://www.msf.org/
Latest [Selected Announcements
Libya
Ongoing violence against detained migrants forces MSF to suspend Tripoli detention centre activities
Press Release 22 Jun 2021

Cameroon
People in northwest seek healthcare as MSF denied providing medical services
Press Release 22 Jun 2021

Ethiopia Tigray crisis
Tigray violence scatters people across two countries
Crisis Update 22 Jun 2021

 

National Academy of Medicine – USA [to 26 Jun 2021]
https://nam.edu/programs/
Selected News/Programs
No new digest content identified.

 

National Vaccine Program Office – U.S. HHS [to 26 Jun 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

 

NIH [to 26 Jun 2021]
http://www.nih.gov/news-events/news-releases
News Releases
International study of rare childhood cancer finds genetic clues, potential for tailored therapy
June 24, 2021 — Rhabdomyosarcoma, or RMS, is a rare cancer that affects the muscles and other soft tissues.

NIH begins study of COVID-19 vaccination during pregnancy and postpartum
June 23, 2021 — Researchers will evaluate antibody responses in vaccinated participants and their infants.

NIH study suggests COVID-19 prevalence far exceeded early pandemic cases
June 22, 2021 — Researchers estimate nearly 17 million undiagnosed cases in the U.S. by mid-July 2020.

 

UN OCHA Office for the Coordination of Humanitarian Affairs [to 26 Jun 2021]
https://www.unocha.org/
Press Releases
No new digest content identified.

 

PATH [to 26 Jun 2021]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

 

Rockefeller Foundation [to 26 Jun 2021]
https://www.rockefellerfoundation.org/
Selected Reports/Press Releases
Jun 23 2021
Press Releases
New Vaccine Equity Cooperative Launches to Advance Covid-19 Vaccine Access and Readiness
Latest Initiative from Collaboration of Racial Health Equity-focused Organizations Includes New Online Resource Hub for Community-Based Workforces
BOSTON, Mass. and OAKLAND, Calif. – The Vaccine Equity Cooperative, a new national collaboration of community health-focused organizations, has launched an online resource hub and information platform to support community-based workforces as they work to increase COVID-19 vaccine access and readiness across the U.S during the most challenging stage of the vaccination effort. As communities of color continue to be disproportionately impacted by vaccine misinformation, mistrust and barriers to access, the website provides curated resources and real-time updates vetted by trusted health care, public health and racial equity experts, as well as opportunities to share content and connect in open forums.

While more than half the adults in the U.S. have been vaccinated, the rate of white people receiving at least one vaccine dose is still 1.4 times higher than that of Black people and 1.2 times higher than that of Hispanic people. People with lingering questions about COVID-19 vaccine safety and access are continuing to turn to trusted local leaders, organizers and health workers in their communities for advice and support about COVID-19 vaccines.

With the country projected to fall short of the Biden administration’s goal of getting 70 percent of American adults at least partially vaccinated by July 4th, supporting local outreach and 1:1 conversations with those facing the most barriers and skepticism will be essential to the success of vaccination efforts, efforts to safely re-open and long-term national public health.

“Community-based and public health workforces have long been underfunded and under-supported, but proved to be absolutely critical to the pandemic response and vaccine rollout,” said Alexandra Quinn, CEO of Health Leads. “The Vaccine Equity Cooperative envisions a world where local workforces have the resources they need – not only to respond to crises, but proactively address ongoing barriers to health. With a goal of enabling racial health equity, our Cooperative will be an ongoing effort to strengthen our public and community health infrastructure through public and private investment, advocacy, and sharing resources and learnings from and with communities across the country.”

Difficulties in accessing accurate information, online registration, language barriers, hard-to-reach vaccination sites and failure of institutions to gain trust are only a few of the factors that have contributed to the disparities in U.S. vaccination rates. While other general population vaccine-related resource hubs exist, the Cooperative’s site offers curated toolkits tailored to community types and drawn from trusted organizations and local leaders.

“Frontline community-based workers and leaders have been the trusted sources and translators of complex health information for generations, but COVID-19 vaccines introduced a host of new data, questions and misinformation,” said Denise Octavia Smith, Executive Director of the National Association of Community Health Workers, a founding partner of the project. “This website helps them navigate readiness and access efforts with community-specific tools and resources from people and organizations that they can trust.”

The Cooperative is encouraging all community-based workforce members to collaborate on the project by giving feedback on published resources, sending questions and requests for information, or sharing new resources and events for publication on the site.

About the Vaccine Equity Cooperative
Visit the resource hub and learn more about the Vaccine Equity Cooperative at www.vaccineequitycooperative.org.
The Vaccine Equity Cooperative is a national collaboration of organizations committed to racial health equity, including Health Leads, CONVINCE USA, National Association of Community Health Workers, Native Ways Federation and Partners In Health. The Cooperative works to increase access to trusted health resources, expand investment in community-based organizations, and strengthen policy in support of community-based and public health workforces. The Cooperative is supported by The Rockefeller Foundation, The JPB Foundation, The W.K. Kellogg Foundation, and The Kresge Foundation. For more information and the Cooperative’s resource hub, visit www.vaccineequitycooperative.org.

 

Sabin Vaccine Institute [to 26 Jun 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 26 Jun 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
25 June 2021
Training on data on the location and size estimates of key populations in western and central Africa

21 June 2021
Small steps towards a big goal

21 June 2021
The importance of young people’s sexual and reproductive health and rights to the global HIV response

 

UNHCR Office of the United Nations High Commissioner for Refugees [to 26 Jun 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected News Releases, Announcements
UNHCR calls on states to remove barriers to access to COVID-19 vaccines for refugees
24 June 2021
[See COVID above for detail]

 

 

UN agencies welcome relocation of 4,000 asylum seekers and refugees from Greece
IOM, UNHCR and UNICEF jointly encourage further steps towards a predictable, systematic European relocation mechanism.
24 June 2021

 

 

UN High Commissioner for Refugees praises Latin America for its commitment to the inclusion of all those in need of protection
23 June 2021
Quito, Ecuador – At the end of a week-long visit to three Latin American countries, UN High Commissioner for Refugees Filippo Grandi applauded the region for its solidarity and commitment to protect refugees, asylum seekers and other displaced people.
“Latin American countries are facing an unprecedented level of displacement,” said Grandi. “Yet, they have stepped up to the challenge by showing unique generosity and dedication to find dignified solutions for those forced to flee.”
The Americas region is home to 20 per cent of the 82.4 million people forcibly displaced globally, including the second-largest external displacement crisis in the world – the 5.6 million refugees and migrants from Venezuela. As Latin America struggles to contain the COVID-19 pandemic, several countries have initiated large-scale regularization programmes to realize the full potential of displaced people and the contribution they can make to their communities.
“Inclusion is one of the most practical and concrete forms of protection. It helps children to get an education, people to receive the medical treatment they need, prevents exploitation and abuse and supports people to acquire the dignity of self-sustaining work,” explained Grandi. “Inclusion is the new protection.”…

 

UNICEF [to 26 Jun 2021]
https://www.unicef.org/media/press-releases
Selected Press Releases, Statements
News note 06/25/2021
Geneva Palais briefing note on the worsening situation in Sub Saharan Africa as a result of secondary impacts of COVID-19
This is a summary of what was said by UNICEF spokesperson James Elder – to whom quoted text may be attributed – at today’s press briefing at the Palais des Nations in Geneva
GENEVA, 25 June 2021 – “Sub-Saharan Africa is in the throes of a deadly uptake in COVID-19. At the present rate of infections, the current surge will exceed the previous one within weeks. As more contagious variants spread, vaccines continue to be perilously slow in reaching Africa, and hospitals are pushed beyond capacity.

“Amid it all, the impacts on children continue to be devastating. So as to provide a very quick regional snapshot:
:: In Uganda there has been a 2,800 per cent increase in new COVID19 cases between March and June 2021.  The availability of oxygen in Uganda become a life or death situation.
:: Namibia, last week, had the highest death rate in Africa. Hospitals are full and there are not enough oxygen tanks. According to the Ministry of Health, Namibia is experiencing over 1,000 new COVID19 cases each day and 30 deaths. That is a high death rate for a country of 2.5 million people.
:: In the Democratic Republic of the Congo, it’s an equally daunting picture – with low vaccination rates and poor health facilities.
:: And in South Africa a third wave is threatening to be even worse than the previous two, stretching an already strained healthcare system. So far, only 2.5 million people have received at least one vaccination, from a population of around 57 million. And yet that’s one of the higher vaccination rates on the continent.
:: Indeed, if we look at the situation across the world, there have been about 2.7 billion doses administered. Of these, around just 1.5% have been administered on the continent.

“What does all this look like for a child in Sub Saharan Africa?
“It looks like the loss of parents, and grandparents who care for so many children; It looks like less education and more abuse. COVID-19 has meant a devastating blow to education. For instance, UNICEF estimates 9 million children in Eastern and Southern Africa never returned to class as schools started opening; And now schools that re-opened are starting to close again; “it looks – and feels – like more anxiety and stress for children, as isolation, confinement, and loss of income take their toll…

 

Unitaid [to 26 Jun 2021]
https://unitaid.org/
Featured News
Unitaid’s Executive Board meets to discuss strategic direction in an evolving global health landscape at 38th meeting
Geneva, 18 June 2021 – The Executive Board recognized Unitaid’s leadership and agility in responding to COVID-19 and discussed new challenges and opportunities facing the organization during its 38th meeting, held virtually from 16th to 18th June.
Unitaid’s board reaffirmed its commitment to its core work and explored lessons learned from the pandemic response and ways its innovative model and expertise could lend itself to additional contexts.
As Unitaid continues its strategy development process for 2022-2026, key among the considerations discussed was how to define ambitions and priorities in a way that allows enough flexibility to ensure success in an increasingly challenging global health environment…

 

Vaccination Acceptance & Demand Initiative [Sabin) [to 26 Jun 2021]
https://www.vaccineacceptance.org/
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 26 Jun 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 26 Jun 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

 

Wellcome Trust [to 26 Jun 2021]
https://wellcome.ac.uk/news
News and reports
Explainer
What treatments are working for Covid-19?
From existing antivirals to new antibody therapies – researchers are working tirelessly to find the best drugs to treat Covid-19.
23 June 2021

 

The Wistar Institute [to 26 Jun 2021]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

 

WFPHA: World Federation of Public Health Associations [to 26 Jun 2021]
https://www.wfpha.org/
Latest News
No new digest content identified.

 

World Bank [to 26 Jun 2021]
http://www.worldbank.org/en/news/all
Selected News, Announcements
US$30m Boost for PNG’s COVID-19 Response
World Bank announces additional support for COVID-19 response and vaccine rollout PORT MORESBY, June 25, 2021 – The World Bank has approved an additional US$30 million (approximately PGK70m) in funding…
Date: June 25, 2021 Type: Press Release

Additional Financing Support by the Green Climate Fund to Help Strengthen Climate Resilience in Central Asia
WASHINGTON, June 24, 2021 — The World Bank, as an accredited entity for the Green Climate Fund (GCF), approved today additional financing totaling $19 million for the Climate Adaptation and Mitigation…
Date: June 24, 2021 Type: Press Release

New $200 Million World Bank Project to Support COVID-19 Relief, Build Resilience Against Future Economic Shocks in Cambodia
WASHINGTON, June 24, 2021 – Cambodia’s efforts to combat the ongoing COVID-19 pandemic and begin its journey toward economic recovery were given a boost today by World Bank’s Board of Executive Directors…
Date: June 24, 2021 Type: Press Release

World Bank Approves US$100 Million for Barbados’ COVID-19 Response and Recovery
WASHINGTON, June 24, 2021 – The World Bank Board of Executive Directors approved today a US$100 million COVID-19 Response and Recovery Development Policy Loan for Barbados. The operation will support the…
Date: June 24, 2021 Type: Press Release

New Grant to Sustain Afghanistan’s Reforms toward COVID-19 Recovery
Washington, June 24, 2021— The World Bank Board of Executive Directors today approved a $132 million grant from the International Development Association (IDA) to help Afghanistan continue implementing…
Date: June 24, 2021 Type: Press Release

Remarks by World Bank Group President David R. Malpass: Avoiding a Lost Decade in Latin America and the Caribbean (LAC)
Thank you, Maria, the Andean American Associations, and all participants throughout the Latin American and Caribbean regions. I also want to thank Juana Caicedo, President of the Ecuadorean American Association…
Date: June 23, 2021 Type: Speeches and Transcripts

US$63.75 Million Additional Financing to Support COVID-19 Vaccination in Jordan
Washington DC, June 23, 2021 – The World Bank approved on June 16, 2021, US$63.75 million in additional financing for the ongoing Jordan COVID-19 Emergency Response project to support Jordan’s efforts…
Date: June 23, 2021 Type: Press Release

World Bank and African Union Team Up to Support Rapid Vaccination for Up to 400 million People in Africa
Working with countries and partners across Africa to quickly expand equitable access to vaccines WASHINGTON, June 21, 2021— The African Finance Ministers and the World Bank Group met today to fast…
Date: June 21, 2021 Type: Press Release

 

World Customs Organization – WCO [to 26 Jun 2021]
http://www.wcoomd.org/
Latest News – Selected Items
26 June 2021
WCO Council renews support for the Secretariat in preparation for a post-pandemic world
Heads of Delegation of some 130 World Customs Organization (WCO) Member Customs administrations took part in the virtual meeting of the 138th Session of the WCO Council, held from 24 to 26 June 2021. As the world is bracing for recovery with a glimmer of optimism emerging from the global effort regarding vaccinations, this session focused on Capacity Building, Rules of Origin, Valuation, Nomenclature and Classification, Compliance and Trade Facilitation as well as budgetary and financial matters…

 

World Organisation for Animal Health (OIE) [to 26 Jun 2021]
https://www.oie.int/en/for-the-media/press-releases/2021/
Press Releases
No new digest content identified.

::::::

 

ARM [Alliance for Regenerative Medicine] [to 26 Jun 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Selected Press Releases
No new digest content identified.

 

BIO [to 26 Jun 2021]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 26 Jun 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 26 Jun 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 26 Jun 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
New Non-State Actors Alliance calls on behalf of patients, industry for urgent action to set
22 June – Paris/Geneva/London – Ministers of Health from four African countries (Algeria, Democratic Republic of Congo, Egypt and Cabo Verde), representatives from international organizations, patient groups and the pharmaceutical industry reiterated today at a high-level roundtable event the urgency of establishing a regulatory authority across Africa, especially in the context of the COVID-19 pandemic. The current fragmented regulatory systems across the continent are making it difficult to mount an appropriate response.
Ministers of Health and roundtable participants outlined the first areas of work for the AMA and agreed that it has the unique opportunity to become one of the most efficient and modern regulatory systems in the world. Once established, it will perform a vital task in overseeing rapid and effective market authorisation of safe, quality, effective and accessible vaccines, medicines, and health devices to control and treat disease across Africa to robust regulatory standards. Crucially, it will foster reliance and regulatory harmonization across the continent. In practice, this means that national regulatory authorities will be able to build on the work done by counterparts in other countries, significantly cutting down the time it takes for medicines, vaccines or diagnostics to reach the market.    For many countries, the AMA also holds the promise of driving industrial and economic growth, through encouraging the development of local pharmaceutical industry and the establishment of centres of excellence for research across the continent.
But while commitment to the AMA mission and vision is strong, it has not translated into concrete actions. A new cross-stakeholder alliance announced at the roundtable, the African Medicines Agency Treaty Alliance (AMATA), will seek to push for rapid ratification of the Treaty, as well as meaningful engagement with patients, industry and other relevant parties once the Agency becomes operational…

Biopharmaceutical CEO Brussel meeting with EU leaders focuses on equitable access to tackle COVID-19, fostering
Brussels, 22 June 2021 – The Biopharmaceutical CEO Roundtable (BCR), which represents the world’s leading biopharmaceutical companies, held their first face-to-face meeting since December 2019 in Brussels on Monday 21 and Tuesday 22 June, to discuss global health challenges and public health policies impacting biomedical innovation.
The fourteen biopharmaceutical industry CEOs who attended in person represent a global industry which is heavily invested in Europe, as key players in the research and development ecosystem, local economies and with health care systems. Their programme…covered a range of topics, including the development and scaling up of COVID-19 vaccines and how to foster an environment that invests in innovation. The CEOs explained the incredible innovations coming down the pipeline for patients, such as combination therapies, advanced therapies and Artificial Intelligence guided therapy.
The multifaceted root cause of unavailability and delay to innovative medicines were discussed, and the need to find solutions to reduce the time before patients have access to innovative medicines. The group tabled a number of proposals including the establishment of an industry portal targeting European access hurdles reflecting the shared aspiration of companies to file pricing and reimbursement applications within 2 years from the granting of the marketing authorization. The CEO delegation made concrete proposals to ensure equity of access and solidarity across EU member states, by means of equity-based tiered pricing, which would require an intergovernmental framework for it to be implementable and effective. There was clearly a shared commitment to ensure safe and efficacious innovative products reach the market and patients, enabled by a first-class regulatory system. The EU’s regulatory system, which stood up well to the pandemic challenges, could remove the bottlenecks and catch up with regulatory systems in other parts of the world in terms of speed and flexibility of assessment by rationalising the decision making (expertise based) and reducing interfaces…

 

PhRMA [to 26 Jun 2021]
http://www.phrma.org/
Latest News
More than 800 medicines are in development for diseases that disproportionately affect racial and ethnic communities
June 22, 2021
PhRMA released a new report exploring the 829 medicines in development that aim to address the diseases and conditions that affect racial and ethnic communities at a higher rate.
Blog Post

Transgenerational Trauma

AMA Journal of Ethics
Volume 23, Number 6: E435-504 June 2021
https://journalofethics.ama-assn.org/issue/transgenerational-trauma

 

Transgenerational Trauma
One thing that makes trauma transgenerational is narrative. Narrative, for example, is what makes a Confederate flag from 1865 flint for insurrection in 2021. Consequences of global and domestic insults, such as slavery and forced migration, have long ramified intergenerationally in communities, families, and individuals’ bodies. Legacies of trauma travel in stories across places and over time, and their effects include health status inequity and cumulative stress embodiment. Transmission of historically entrenched patterns of oppression also influence persons’ lived experiences of marginalization, convey health risk, and can play out during clinical encounters.

Access to water, sanitation and hygiene services in health facilities in sub-Saharan Africa 2013–2018: Results of health facility surveys and implications for COVID-19 transmission

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 26 Jun 2021)

 

Access to water, sanitation and hygiene services in health facilities in sub-Saharan Africa 2013–2018: Results of health facility surveys and implications for COVID-19 transmission
The COVID-19 pandemic has highlighted important needs in water, sanitation and hygiene (WASH) services and standard practices for infection prevention and control in sub-Saharan Africa. We assessed the availab…
Authors: Mufaro Kanyangarara, Savannah Allen, Safia S Jiwani and David Fuente
Citation: BMC Health Services Research 2021 21:601
Content type: Research article
Published on: 25 June 2021

Principles for pandemics: COVID-19 and professional ethical guidance in England and Wales

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 26 Jun 2021)

 

Principles for pandemics: COVID-19 and professional ethical guidance in England and Wales
During the arrival of the COVID-19 pandemic, various professional ethical guidance was issued to (and for) health and social care professionals in England and Wales. Guidance can help to inform and support suc…
Authors: Helen Smith, Peta Coulson-Smith, Mari-Rose Kennedy, Giles Birchley, Jonathan Ives and Richard Huxtable
Citation: BMC Medical Ethics 2021 22:78
Content type: Research
Published on: 24 June 2021

Who should be tested in a pandemic? Ethical considerations

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 26 Jun 2021)

 

Who should be tested in a pandemic? Ethical considerations
In the initial phase of the Covid-19 pandemic, difficult decisions had to be made on the allocation of testing resources. Similar situations can arise in future pandemics. Therefore, careful consideration of w…
Authors: Sven Ove Hansson, Gert Helgesson and Niklas Juth
Citation: BMC Medical Ethics 2021 22:76
Content type: Review
Published on: 22 June 2021

Disparity in the quality of COVID-19 data reporting across India

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 26 Jun 2021)

 

Disparity in the quality of COVID-19 data reporting across India
Transparent and accessible reporting of COVID-19 data is critical for public health efforts. Each Indian state has its own mechanism for reporting COVID-19 data, and the quality of their reporting has not been…
Authors: Varun Vasudevan, Abeynaya Gnanasekaran, Varsha Sankar, Siddarth A. Vasudevan and James Zou
Citation: BMC Public Health 2021 21:1211
Content type: Research article
Published on: 24 June 2021

Investigation of the relationships between perceived causes of COVID-19, attitudes towards vaccine and level of trust in information sources from the perspective of Infodemic: the case of Turkey

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 26 Jun 2021)

 

Investigation of the relationships between perceived causes of COVID-19, attitudes towards vaccine and level of trust in information sources from the perspective of Infodemic: the case of Turkey
The main purpose in this study carried out from the perspective of infodemic was to investigate the relationships between individuals’ perceived causes of COVID-19, their attitudes towards vaccine and their le…
Authors: Şemsi Nur Karabela, Filiz Coşkun and Haydar Hoşgör
Citation: BMC Public Health 2021 21:1195
Content type: Research
Published on: 23 June 2021

The Next Set of COVID-19 Vaccines: Leveraging New Development Platforms to Increase Access for More People Around the World

Clinical Therapeutics
Volume 43 Issue 4 p651-792
http://www.clinicaltherapeutics.com/current

 

COVID
The Next Set of COVID-19 Vaccines: Leveraging New Development Platforms to Increase Access for More People Around the World
Ravi Jhaveri
Published online: March 23, 2021
Abstract
The approval of the coronavirus disease 2019 (COVID-19) mRNA vaccines brought much optimism to efforts to end the pandemic. A recombinant adenovirus vaccine recently received emergency use authorization, and several other vaccines are likely to follow. These vaccines all use relatively new vaccine production platforms to produce the severe acute respiratory syndrome coronavirus 2 Spike protein. This review discusses how these platforms work, what advantages they offer, and the gaps that remain in public health efforts to control the COVID-19 pandemic.

Managing borders during public health emergencies of international concern: a proposed typology of cross-border health measures

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 26 Jun 2021]

 

Managing borders during public health emergencies of international concern: a proposed typology of cross-border health measures
Authors: Kelley Lee, Karen A. Grépin, Catherine Worsnop, Summer Marion, Julianne Piper and Mingqi Song
Content type: Research
21 June 2021

Localisation and local humanitarian action

Humanitarian Exchange Magazine
Number 79, May 2021
https://odihpn.org/magazine/inclusion-of-persons-with-disabilities-in-humanitarian-action-what-now/

 

Localisation and local humanitarian action
by HPN October 2020
The theme of this edition of Humanitarian Exchange is localisation+ and local humanitarian action. Five years ago this week, donors, United Nations (UN) agencies,  non-governmental organisations (NGOs), the International Committee of the Red Cross (ICRC) and International Federation of Red Cross and Red Crescent Societies (IFRC) committed within the Grand Bargain to increase multi-year investments in the institutional capacities of local and national responders, and to provide at least 25% of humanitarian funding to them as directly as possible. Since then, there is increasing consensus at policy and normative level, underscored by the Covid-19 pandemic, that local leadership should be supported.  Localisation has gone from a fringe conversation among policy-makers and aid agencies in 2016 to a formal priority under the Grand Bargain. Wider global movements on anti-racism and decolonisation have also brought new momentum to critical reflections on where power, knowledge and capacity reside in the humanitarian system. Yet progress has been slow and major gaps remain between the rhetoric around humanitarian partnerships, funding and coordination and practices on the ground.

US Case Reports of Cerebral Venous Sinus Thrombosis

JAMA
June 22/29, 2021, Vol 325, No. 24, Pages 2419-2512
https://jamanetwork.com/journals/jama/currentissue

 

Original Investigation
US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021
Isaac See, MD; John R. Su, MD, PhD, MPH; Allison Lale, MD, MPH; et al.
free access
JAMA. 2021;325(24):2448-2456. doi:10.1001/jama.2021.7517
This study describes the reported US cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following vaccination with Ad26.COV2.S, the COVID-19 vaccine produced by Janssen/Johnson & Johnson.

Association Between Vaccination With BNT162b2 and Incidence of Symptomatic and Asymptomatic SARS-CoV-2 Infections Among Health Care Workers

JAMA
June 22/29, 2021, Vol 325, No. 24, Pages 2419-2512
https://jamanetwork.com/journals/jama/currentissue

 

Association Between Vaccination With BNT162b2 and Incidence of Symptomatic and Asymptomatic SARS-CoV-2 Infections Among Health Care Workers
Yoel Angel, MD, MBA; Avishay Spitzer, MD; Oryan Henig, MD; et al.
free access has active quiz
JAMA. 2021;325(24):2457-2465. doi:10.1001/jama.2021.7152
This cohort study estimates the association between Pfizer-BioNTech BNT162b2 vaccination and symptomatic and asymptomatic SARS-CoV-2 infections among health care workers more than 7 days after receipt of a second vaccine dose.

Asymptomatic and Symptomatic SARS-CoV-2 Infections After BNT162b2 Vaccination in a Routinely Screened Workforce

JAMA
June 22/29, 2021, Vol 325, No. 24, Pages 2419-2512
https://jamanetwork.com/journals/jama/currentissue

 

Research Letter
Asymptomatic and Symptomatic SARS-CoV-2 Infections After BNT162b2 Vaccination in a Routinely Screened Workforce
Li Tang, PhD; Diego R. Hijano, MD, MSc; Aditya H. Gaur, MD, MBBS; et al.
free access has active quiz
JAMA. 2021;325(24):2500-2502. doi:10.1001/jama.2021.6564
This study aims to describe an association between the Pfizer-BioNTech (BNT162b2) vaccine and decreased risk of symptomatic and asymptomatic infections with SARS-CoV-2 in hospital employees.

When Vaccine Apathy, Not Hesitancy, Drives Vaccine Disinterest

JAMA
June 22/29, 2021, Vol 325, No. 24, Pages 2419-2512
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
When Vaccine Apathy, Not Hesitancy, Drives Vaccine Disinterest
Stacy Wood, PhD; Kevin Schulman, MD
free access
JAMA. 2021;325(24):2435-2436. doi:10.1001/jama.2021.7707
This Viewpoint explains how vaccine apathy rather than hesitancy may lead to population undervaccination, and uses marketing principles to explain how public health messaging might differ to persuade apathetic persons to be immunized to achieve more widespread COVID-19 protection.

Overview of the Issue

Journal of Health Care for the Poor and Underserved (JHCPU)
Volume 32, Number 2, May 2021 Supplement
https://muse.jhu.edu/issue/44396

 

Table of Contents
Overview of the Issue
Kevin B. Johnson, Tiffani J. Bright, Cheryl R. Clark
…The importance of techquity—defined as the strategic development and deployment of technology in health care and health to advance health equity—was even more apparent after the events of 2020. COVID-19 upended access to care and illuminated the impact of structural racism as a cause for a widening gap of access during the pandemic. Black Lives Matter became more than a trending hashtag on Twitter, or a movement resulting in peaceful protests and calls for policy reform: it put additional focus on the issue of race as a social and not a biological construct and called into question the rationale for common practices in health care that were triggered by race. A notable example was the emerging realization that kidney function assessment was tied to race and hardwired into many of our electronic health records. The real-world evidence around our lack of techquity was incontrovertible.
This Supplemental Issue of JHCPU provides articles that describe challenges to techquity, frameworks to improve the role of technology in care, and examples of how technology can transform health, public health, and health care…

Changes in Strength of Recommendation and Perceived Barriers to Human Papillomavirus Vaccination: Longitudinal Analysis of Primary Care Physicians, 2008-2018

Journal of Pediatrics
Volume 234 p1-296
http://www.jpeds.com/current

 

Original Articles
Changes in Strength of Recommendation and Perceived Barriers to Human Papillomavirus Vaccination: Longitudinal Analysis of Primary Care Physicians, 2008-2018
Jessica R. Cataldi, et al
Published online: March 06, 2021
p149-157.e3

SARS-CoV-2 vaccine-induced immune thrombotic thrombocytopenia treated with immunoglobulin and argatroban

The Lancet
Jun 26, 2021 Volume 397 Number 10293 p2439-2536, e17-e19
https://www.thelancet.com/journals/lancet/issue/current

 

Clinical Picture
SARS-CoV-2 vaccine-induced immune thrombotic thrombocytopenia treated with immunoglobulin and argatroban
Katharina Guetl, Thomas Gary, Reinhard B Raggam, Johannes Schmid, Albert Wölfler, Marianne Brodmann

Neutralizing antibody vaccine for pandemic and pre-emergent coronaviruses

Nature
Volume 594 Issue 7864, 24 June 2021
https://www.nature.com/nature/volumes/594/issues/7864

 

Article | 10 May 2021
Neutralizing antibody vaccine for pandemic and pre-emergent coronaviruses
Immunization of macaques with nanoparticle-conjugated receptor-binding domain of SARS-CoV-2 adjuvanted with 3M-052 and alum results in cross-neutralizing antibodies against bat coronaviruses, SARS-CoV and SARS-CoV-2 variants, and may provide a platform for developing pan-coronavirus vaccines.
Kevin O. Saunders, Esther Lee, Barton F. Haynes