Vaccines and Global Health: The Week in Review :: 8 May 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

G7 Foreign and Development Ministers’ Meeting, May 2021: communiqué

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G7 Foreign and Development Ministers’ Meeting, May 2021: communiqué
Published 5 May 2021
[Excerpts]

2. We affirm the need to take collective action on the most pressing foreign and security challenges. The COVID-19 pandemic has underscored that global challenges require global collaboration. We reaffirm that investments in health systems will strengthen economic growth and our ability to respond to future pandemic threats. We reaffirm our commitment to working with developing partner countries, especially in Africa, to achieve a green, inclusive and sustainable recovery from COVID-19, aligned with the 2030 Agenda and the Paris Agreement, including urgent equitable access to vaccines, therapeutics and diagnostics. We commit to supporting developing partner countries to tackle and prevent the interlinked threats of conflict, climate change, poverty, food insecurity, and the health, humanitarian, human rights and economic effects of COVID-19; and building back better so that we are more prepared for future pandemics. We are deeply concerned that the pandemic has further set back progress towards the Sustainable Development Goals (SDGs). We commit to making increased efforts towards achieving the SDGs by 2030, and commit to ensuring that no-one is left behind…

 

Enabling equitable global access to COVID-19 vaccines, therapeutics and diagnostics (VTDs)
62. We affirm our belief that commitment to an open, transparent and multilateral approach is essential in responding to the global health impacts of COVID-19. A global health emergency on this scale requires co-ordinated action and global solidarity. We reaffirm our support for all existing pillars of Access to COVID-19 Tools Accelerator (ACT-A), including its COVAX facility. We recognise that equipping the ACT-Accelerator with adequate funding is central. We support the strengthening of health systems, and affordable and equitable global access to vaccines, therapeutics and diagnostics, and we will further increase our efforts to support affordable and equitable access for people in need, taking approaches consistent with members’ commitments to incentivise innovation… In this context, we look forward to the COVAX Advance Market Commitment (AMC) Summit to be co-hosted by Gavi and Japan following the COVAX AMC One World Protected Event co-hosted by Gavi and US.

63. We commit to the G7 Foreign and Development Ministers’ Equitable Access and Collaboration Statement to help accelerate the end of the acute phase of the COVID-19 pandemic. We commit to supporting COVAX financially, including by encouraging pledges to the Facility, including at the COVAX AMC Summit in June, disbursing as soon as possible, providing in-kind contributions, and coordinating with and using COVAX, which is the key mechanism for global sharing of vaccines to supplement its own direct procurement, to enable the rapid equitable deployment of vaccines.

64. We support the work of G7 Health Ministers and continued G7 efforts to work with partners to improve pandemic preparedness and global health security, with WHO as the leading and co-ordinating authority, to strengthen health systems, develop solutions that embed a One Health approach, tackle antimicrobial resistance, and accelerate progress towards universal health coverage and the health-related Sustainable Development Goals. We welcome the establishment of the One Health High Level Experts Panel supported by WHO, FAO, OIE and UNEP…

65. We note the continuing need to support health systems and health security and secure sustainable financing, together with partner countries’ domestic resources, to help accelerate global vaccine development and deployment, recover and then sustain access to essential health and nutrition services and health commodities, including in humanitarian settings and for sexual and reproductive health and rights, and to bolster the global health architecture for pandemic preparedness, including through stronger rapid response mechanisms… We look forward to working with G7 Finance Ministers to build consensus on practical actions to facilitate access to existing global financing sources to meet demands for access to COVID-19 vaccines, therapeutics and diagnostics, as well as how best to tackle the ACT-A funding gaps, with the aim of shortening the lifespan of the pandemic and with particular focus on the needs of vulnerable countries. In this regard, we look forward to the outcomes of the Independent Panel for Pandemic Preparedness and Response (IPPPR) initiated by the WHO, and the High Level Independent Panel on financing the global commons for pandemic preparedness and response (HLIP) established by the G20…

WHO, Germany launch new global hub for pandemic and epidemic intelligence

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WHO, Germany launch new global hub for pandemic and epidemic intelligence
5 May 2021 Joint News Release
Geneva/Berlin
:: The WHO Hub for Pandemic and Epidemic Intelligence will be a global platform for pandemic and epidemic intelligence, creating shared and networked access to vital multi-sectoral data, driving innovations in data analytics and building the communities of practice needed to predict, prevent, detect, prepare for and respond to worldwide health threats.
:: The WHO Hub will be a new global collaboration of countries and partners worldwide, driving innovations to increase availability and linkage of diverse data; develop tools and predictive models for risk analysis; and to monitor disease control measures and infodemics. 
:: The WHO Hub will enable partners from around the world to collaborate and co-create the tools and data access that all countries need to prepare, detect and respond to pandemic and epidemic risks.

The World Health Organization (WHO) and the Federal Republic of Germany will establish a new global hub for pandemic and epidemic intelligence, data, surveillance and analytics innovation. The Hub, based in Berlin and working with partners around the world, will lead innovations in data analytics across the largest network of global data to predict, prevent, detect prepare for and respond to pandemic and epidemic risks worldwide.

H.E. German Federal Chancellor Dr Angela Merkel said: “The current Covid-19 pandemic has taught us that we can only fight pandemics and epidemics together. The new WHO Hub will be a global platform for pandemic prevention, bringing together various governmental, academic and private sector institutions. I am delighted that WHO chose Berlin as its location and invite partners from all around the world to contribute to the WHO hub.”

The WHO Hub for Pandemic and Epidemic Intelligence is part of WHO’s Health Emergencies Programme and will be a new collaboration of countries and partners worldwide, driving innovations to increase availability and linkage of diverse data; develop tools and predictive models for risk analysis; and to monitor disease control measures, community acceptance and infodemics. Critically, the WHO Hub will support the work of public health experts and policy-makers in all countries with insights so they can take rapid decisions to prevent and respond to future public health emergencies…

Joint Statement on transparency and data integrity – International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO)

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Joint Statement on transparency and data integrity – International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO)
7 May 2021
ICMRA* and WHO call on the pharmaceutical industry to provide wide access to clinical data for all new medicines and vaccines (whether full or conditional approval, under emergency use, or rejected). Clinical trial reports should be published without redaction of confidential information for reasons of overriding public health interest.

The COVID-19 pandemic has brought into sharp focus the need for information and data to support academics, researchers and industry in developing vaccines and therapeutics; to support regulators and health authorities in their decision-making; to support healthcare professionals in their treatment decisions; and to support public confidence in the vaccines and therapeutics being deployed.

While some initiatives have met with stakeholder support (e.g. WHO International Clinical Trials Registry Platform, US NIH ClinicalTrials.gov database, Health Canada Clinical Information Portal, EMA Clinical Trials Register and Japan Registry of Clinical Trials), not all past efforts have been successful. Often this was because they were unsustainable due to reliance on goodwill or lack of appropriate resourcing**.

The common aim of these initiatives is to ensure that results of research are accessible to all those involved in health care decision-making. The priority should be for new innovative medicines and vaccines. This improves transparency and strengthens the validity and value of the scientific evidence base. To succeed, initiatives need multi-stakeholder engagement aimed at finding solutions that deliver benefits for public health.

Regulators continue to spend considerable resources negotiating transparency with sponsors. Both positive and negative clinically relevant data should be made available, while only personal data and individual patient data should be redacted. In any case, aggregated data are unlikely to lead to re-identification of personal data and techniques of anonymisation can be used.

 

The first benefit is public trust. Regulators are opening their decisions to public scrutiny demonstrating confidence in their work.

Another benefit is the possible check of data integrity, a scientific necessity and an ethical must. Data must be robust, exhaustive and verifiable, through peer-review. Data integrity is priceless. Wrong regulatory decisions, made on selected or unreliable data, will affect the patients who receive that medicine.

Lack of public access to negative trials has been identified as a source of bias, which weakens the conclusions of systematic reviews and provides a false sense of reassurance on the safety or efficacy of the medicine.

Publication of data allows science to advance faster, by avoiding repetition of unnecessary trials and waste of resources (human and financial). This also brings benefits by improving the efficiency of development programmes and reducing both development costs and time. Publication of data also allows secondary analyses (and meta-analysis) which have a different or complementary focus.

Many public bodies have made open access a requirement as data are a common good. Providing access to data is also owed to trial participants who contributed physically and took the potential research risks.

Not all data are of high quality, and increased public scrutiny should eventually improve the overall quality of data. Resources however are needed for data sharing, and systems for such access need to be established. Standardisation of data will allow better analyses but is not a requirement.

While there may be a small risk of misuse of data (piracy or data mining for unfair commercial purpose) and misinterpretation, trial data can be put in context when published with the regulatory review of such data.

Data must be published at the time of finalisation of the regulatory review. It cannot be justified to keep confidential efficacy and safety data of a medicine available on the market, or which has been refused access to the market. Some regulators regularly publish the data that support positive approvals, but fewer do this for rejections, while this should avoid false expectations, misuse (accidental or not) and safety issues. Many completed trials on publication platforms only disclose protocols while results remain partial, outdated or unpublished.

ICMRA and WHO are conscious of concerns that some stakeholders may have as regulators move to greater levels of transparency, but we remain confident of the overwhelming positive public health benefits of doing so.

 

Providing systematic public access to data supporting approvals and rejections of medicines reviewed by regulators, is long overdue despite existing initiatives, such as those from the European Medicines Agency and Health Canada. The COVID-19 pandemic has revealed how essential to public trust access to data is. ICMRA and WHO call on the pharmaceutical industry to commit, within short timelines, and without waiting for legal changes, to provide voluntary unrestricted access to trial results data for the benefit of public health.

* ICMRA is a voluntary coalition of leaders of medicines regulatory authorities that provides strategic directions for enhanced cooperation, improved communication and effective global crisis response mechanisms.
** E.g. Past declarations and private initiatives abandoned or not followed through include:
— Walsh F (26 February 2013), “Drug firm Roche pledges greater access to trials data”
— Alltrials Campaign,
https://www.alltrials.net/ (most recent data from March 2019)
— WHO and multi-party Joint statement on public disclosure of results from clinical trials, 18 May 2017 (accessed
here, March 2021).

 

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IFPMA Response on Joint Statement on transparency and data integrity by International Coalition of Medicines
Geneva, 7 May 2021 – The R&D-based biopharmaceutical industry is fully committed to enhancing public health through responsible sharing of clinical trial data in a manner that ensures safeguarding the privacy of patients, clinical investigators and trial participants; respecting the integrity of national regulatory systems; and maintaining incentives for investment in biomedical research.

We recognize the call from ICMRA & WHO to share knowledge and information with the scientific community to better inform patients, healthcare providers and researchers and the public about ongoing regulatory processes and procedures to facilitate trust in our shared interest in providing safe and efficacious treatments and vaccines. We are widely supportive of sharing data and providing access to clinical trial results.

The R&D-based industry provides access to trial results data for the benefit of public health. For example, biopharmaceutical companies routinely collaborate with academic researchers, publish their clinical research in peer-reviewed literature, and share clinical trial information including results on public websites (such as WHO International Clinical Trials Registry Platform, US NIH ClinicalTrials.gov database, Health Canada Clinical Information Portal, EU Clinical Trials Register, EMA’s Clinical Data Website and Japan Registry of Clinical Trials). In addition to enhance patient understanding about the clinical trials in which they have participated, biopharmaceutical companies are collaborating with national regulatory authorities to adopt mechanisms for providing lay summaries of clinical trial results to research participants consistent with applicable laws and rules.

Report – Powering Vaccine R&D: Opportunities for Transformation

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Report – Powering Vaccine R&D: Opportunities for Transformation
SABIN-ASPEN VACCINE SCIENCE & POLICY GROUP
This publication is based on work funded by the Bill & Melinda Gates Foundation and the Wellcome
Trust.
2021 :: 164 pages
PDF: https://www.sabinaspengroup.org/app/uploads/2021/05/Sabin-Aspen-Report-2021.pdf

Press Release
Vaccine Science and Policy Experts Call for Transformation of Vaccine R&D Enterprise
WASHINGTON, D.C. – May 4, 2021 – As the world continues to grapple with the significant impact of the COVID-19 pandemic, the global community face an urgent need to develop an efficient, coordinated and sustainable model for a healthy and well-functioning vaccine research and development (R&D) ecosystem.

In a new report, “Powering Vaccine R&D: Opportunities for Transformation,” the Sabin-Aspen Vaccine Science & Policy Group uses lessons learned from the rapid development of COVID-19 vaccines to explore opportunities to overhaul vaccine R&D practices to better prepare for the next pandemic, to make strides against diseases currently without vaccines, and to establish next-generation vaccines that offer meaningful improvements.

“The COVID pandemic and the rapid development of vaccines to fight SARS-CoV-2 have heightened our sense of urgency that the time has come to evolve and reform the vaccine R&D ecosystem with the goal of creating a world free of vaccine-preventable diseases,” said Shirley M. Tilghman, PhD, co-chair of the Group and president emeritus and professor emeritus of Molecular Biology and Public Affairs at Princeton University.

“This report reflects our group’s end-to-end thinking on vaccine science and policy, from continued innovation in developing and deploying vaccines, through equitable distribution of vaccines in low- and middle-income countries, to overcoming vaccine hesitancy and realizing the full benefit of vaccines to individuals, families, and society,” adds Harvey V. Fineberg, MD, PhD, co-chair of the Group and president of the Gordon and Betty Moore Foundation.

Despite remarkable accomplishments in recent years, including the new vaccine development platforms that have enabled the rapid response to COVID-19, challenges and structural barriers remain hat have slowed the development of new and improved vaccines.

The report focuses on five “Big Ideas” that aim to stimulate a more efficient and responsive approach to vaccine research and development:
:: Define leadership roles, responsibilities, and mechanisms of accountability to prepare for the R&D demands that surface in a pandemic, including a leadership model that engages diverse stakeholders, expertise and institutions from across the globe.

:: Propel a transdisciplinary research effort to expand and advance vaccine science, including support for a research infrastructure that creates opportunities for novel and high-risk/high-reward ideas, leverages lessons from other scientific areas, ranging from the chemistry and physics of vaccine formulation to the immunologic basis of protection, and creates two-way learning opportunities between research focused on pandemics and on longstanding endemic diseases.

:: Restructure regulatory science to reflect advances in vaccine R&D to make vaccine trials faster, nimbler, and more cost-effective as well as to enhance product scale-up and manufacturing and post-market surveillance.

:: Reimagine clinical trials to feature equity and efficiency as prime drivers, with lower- and middle-income countries as full partners in clinical trial development at every stage.

:: Position vaccines as a public good and align incentives so that benefits accrue to all sectors of society, including a strong push to develop or maintain policies and practices that promote information sharing and collaborative problem-solving.

These recommendations offer the opportunity to advance and accelerate vaccine development and should be a critical part of any effort to reexamine and restructure the R&D component of the vaccine/vaccination ecosystem, a particularly relevant undertaking as the world continues to address and learn lessons from the COVID-19 response.

“The rapid generation and distribution of effective COVID-19 vaccines have demonstrated the efficiency that can be achieved through heightened collaboration, cooperation and data sharing across multiple contributing disciplines,” said Bob Tepper, Group member and co-founder and partner at Third Rock Ventures. “This offers a blueprint for the future where worldwide coordination of scientific, clinical, regulatory and distribution efforts must be established as the new norm.”

The Sabin-Aspen Vaccine Science & Policy Group is a partnership which brings together senior leaders across many disciplines to examine some of the most challenging vaccine-related issues and drive impactful change. The meeting of the Sabin-Aspen Vaccine Science & Policy Group and its research and report were funded by the Bill & Melinda Gates Foundation and the Wellcome Trust.

COVID Vaccines IP – TRIPS Waiver Debate

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COVID Vaccines IP – TRIPS Waiver Debate

Statement from Ambassador Katherine Tai on the Covid-19 Trips Waiver
05/05/2021
WASHINGTON – United States Trade Representative Katherine Tai today released a statement announcing the Biden-Harris Administration’s support for waiving intellectual property protections for COVID-19 vaccines.
“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures.  The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines. We will actively participate in text-based negotiations at the World Trade Organization (WTO) needed to make that happen. Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved.
“The Administration’s aim is to get as many safe and effective vaccines to as many people as fast as possible.  As our vaccine supply for the American people is secured, the Administration will continue to ramp up its efforts – working with the private sector and all possible partners – to expand vaccine manufacturing and distribution.  It will also work to increase the raw materials needed to produce those vaccines.”

 

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WHO Director-General commends United States decision to support temporary waiver on intellectual property rights for COVID-19 vaccines
5 May 2021 News release
WHO Director-General Dr Tedros Adhanom Ghebreyesus praised the commitment by the United States administration of President Joe Biden and Vice-President Kamala Harris to support the temporary waiver of intellectual property on COVID-19 vaccines in a bold move to end the pandemic as quickly as possible.
“This is a monumental moment in the fight against COVID-19. The commitment by the President of the United States Joe Biden and Ambassador Katherine Tai, the US Trade Representative, to support the waiver of IP protections on vaccines is a powerful example of American leadership to address global health challenges,” said Dr Tedros…

 

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Unitaid statement on US support for IP waiver for COVID-19 vaccines
Geneva, 6th May 2021 –
Unitaid welcomes the decision of the United States government to support a waiver of intellectual property protections for COVID-19 vaccines.
This is an important step forwards for equitable access in the context of the current World Trade Organization (WTO) negotiations around Trade-Related Aspects of Intellectual Property Rights (TRIPS), and we applaud the leadership of President Joe Biden, Vice-President Kamala Harris, and Ambassador Katherine Tai.
Alongside vaccines, there is a need to have broad access to all the tools to fight COVID-19 – including treatments – for low- and middle-income countries in Africa, Asia, and Latin America, which are currently carrying the heaviest burden of the pandemic.
An important component, alongside the waiver of intellectual property rights, will be the transfer of technology, so that manufacturers can receive the know-how to scale up production quickly. This equally applies to therapeutic products such as monoclonal antibodies, which could be an important tool in the COVID-19 response.
The current crisis of rising case numbers, new variants and constrained oxygen supply illustrates the urgent need for rapid action both in-country and at a global level. We encourage the international community to mobilise to make the tools to fight COVID-19 available to everyone, everywhere.
Marisol Touraine, Chair of the Unitaid Executive Board
Dr Philippe Duneton, Executive Director, Unitaid

 

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IFPMA Statement on WTO TRIPS Intellectual Property Waiver
Geneva, 5 May 2021 – The decision of the US administration to support a patent waiver for COVID-19 vaccines is disappointing. We are fully aligned with the goal to ensure COVID-19 vaccines are quickly and equitably shared around the world. But, as we have consistently stated, a waiver is the simple but the wrong answer to what is a complex problem. Waiving patents of COVID-19 vaccines will not increase production nor provide practical solutions needed to battle this global health crisis. On the contrary, it is likely to lead to disruption; while distracting from addressing the real challenges in scaling up production and distribution of COVID-19 vaccines globally: namely elimination of trade barriers, addressing bottlenecks in supply chains and scarcity of raw materials and ingredients in the supply chain, and a willingness by rich countries to start sharing doses with poor countries.

While the decision of the US administration does not address the real challenges in vaccinating the world, industry will not waver in its commitment to provide safe, effective and quality vaccines and therapeutics. We will continue to leave no stone unturned to further scale up manufacturing of COVID-19 vaccines, as no one is safe until everyone is safe. The international intellectual property system has given companies confidence to engage in more than 200 technology transfer agreements to expand delivery on COVID-19 vaccines based on unprecedented partnerships between vaccine industrialized and developing country vaccine manufacturers. The only way to ensure quick scaling up of and equitable vaccine access to all those in need remains pragmatic and constructive dialogue with the private sector.

 

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PhRMA Statement on WTO TRIPS Intellectual Property Waiver
WASHINGTON, D.C. (May 5, 2021) – Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl made the following statement after the United States Trade Representative expressed support for a proposal to waive patent protections for COVID-19 medicines:

“In the midst of a deadly pandemic, the Biden Administration has taken an unprecedented step that will undermine our global response to the pandemic and compromise safety. This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines.

“This change in longstanding American policy will not save lives. It also flies in the face of President Biden’s stated policy of building up American infrastructure and creating jobs by handing over American innovations to countries looking to undermine our leadership in biomedical discovery. This decision does nothing to address the real challenges to getting more shots in arms, including last-mile distribution and limited availability of raw materials. These are the real challenges we face that this empty promise ignores.

“In the past few days alone, we’ve seen more American vaccine exports, increased production targets from manufacturers, new commitments to COVAX and unprecedented aid for India during its devastating COVID-19 surge. Biopharmaceutical manufacturers are fully committed to providing global access to COVID-19 vaccines, and they are collaborating at a scale that was previously unimaginable, including more than 200 manufacturing and other partnerships to date. The biopharmaceutical industry shares the goal to get as many people vaccinated as quickly as possible, and we hope we can all re-focus on that shared objective.”

 

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Support of “TRIPS” Waiver Sets Dangerous Precedent – BIO
May 5, 2021
Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), released the following statement in response to the White House’s support of waiving critical intellectual property rights for COVID-19…
…”Handing needy countries a recipe book without the ingredients, safeguards, and sizable workforce needed will not help people waiting for the vaccine. Handing them the blueprint to construct a kitchen that – in optimal conditions – can take a year to build will not help us stop the emergence of dangerous new COVID variants. The better alternative would have been to follow through on the President’s pledge just last week to make the United States the world’s “arsenal of vaccines”.  This policy leads in the opposite direction….

COVID Vaccines – OCHA:: HDX

Milestones :: Perspectives :: Research

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COVID Vaccines – OCHA:: HDX

COVID-19 Data Explorer: Global Humanitarian Operations
COVID-19 Vaccine Roll-out
Apr 30, 2021 | COVAX (WHO,GAVI,CEPI), UNDESA, Press Reports | DATA
Global COVID-19 Figures: 149M total confirmed cases; 3.1M total confirmed deaths
Global vaccines administered: 1.24B
Number of Countries: 26
COVAX First Allocations (Number of Doses): 73M
COVAX Delivered (Number of Doses): 13M
Other Delivered (Number of Doses): 24M
Total Delivered (Number of Doses): 36M
Total Administered (Number of Doses): 15M

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

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

 

Weekly Epidemiological and Operational updates
Last update: 8 May 2021
Confirmed cases :: 156 496 592 [week ago: 50 989 419]
Confirmed deaths :: 3 264 143 [week ago: 3 173 576]
Vaccine doses administered: 1 171 658 745

 

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Weekly operational update on COVID-19 – 3 May 2021
Overview
In this edition of the Weekly Operational Update on COVID-19, highlights of country-level actions and WHO support to Member States include:
:: Addressing critical gaps urgently in India
:: Lifesaving supplies donated to Gambia for the COVID-19 response
:: Medical oxygen delivery and trainings in Somalia
:: Training national laboratory mentors in Kazakhstan
:: Essential equipment handed over to support Mongolia
:: Strengthening the COVID-19 response with OpenWHO in Indonesia
:: Hosting a webinar on safe, functional, climate-resilient and environmentally sustainable health facilities post-COVID-19
:: The Strategic Preparedness and Response Plan (SPRP) 2021 resource requirements and progress made to continue investing in the COVID-19 response and for building the architecture to prepare for, prevent and mitigate future health emergencies
:: Updates on WHO/PAHO procured items, Partners Platform, implementation of the Unity Studies, and select indicators from the COVID-19 Monitoring and Evaluation Framework

 

Weekly epidemiological update on COVID-19 – 4 May 2021
Overview
For the second successive week, the number of COVID-19 cases globally remains at the highest levels since the beginning of the pandemic with over 5.7 million new weekly cases, following nine consecutive weeks of increases. New deaths continue to increase for the seventh consecutive week, with over 93 000 deaths. The South-East Asia Region continues to report marked increases in both case and death incidences.
In this edition, special focus updates are provided on:
:: World Hand Hygiene Day, 5 May 2021
:: WHO partnership with SeroTracker — synthesizing “real-time” seroprevalence data to support global pandemic response
:: SARS-CoV-2 variants

WHO – COVID Vaccines EUAL, Prequalification, SAGE Meetings/Recommendations

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WHO – COVID Vaccines EUAL, Prequalification, SAGE Meetings/Recommendations

WHO lists additional COVID-19 vaccine for emergency use and issues interim policy recommendations
7 May 2021 News release
WHO today listed the Sinopharm COVID-19 vaccine for emergency use, giving the green light for this vaccine to be rolled out globally. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG). 

“The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products. “We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution.”

WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. 

The EUL assesses the quality, safety and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. The assessment is performed by the product evaluation group, composed by regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be  listed for emergency use and, if so, under which conditions.

In the case of the Sinopharm vaccine, the WHO assessment included on-site inspections of the production facility. 

The Sinopharm product is an inactivated vaccine called SARS-CoV-2 Vaccine (Vero Cell). Its easy storage requirements make it highly suitable for low-resource settings. It is the also first vaccine that will carry a vaccine vial monitor, a small sticker on the vaccine vials that change color as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.

WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has also completed its review of the vaccine. On the basis of all available evidence, WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks. Vaccine efficacy for symptomatic and hospitalized disease was estimated to be 79%, all age groups combined.
Few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group.  Nevertheless, WHO is not recommending an upper age limit for the vaccine because preliminary data and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons.  There is no theoretical reason to believe that the vaccine has a different safety profile in older and younger populations.  WHO therefore recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to make the recommendation more robust…

Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – 29 April 2021
Presentations
:: COVID-19 Vaccine (Vero Cell), Inactivated-Sinovac Biotech LTD
:: Evidence Assessment: Sinovac/CoronaVac COVID-19 vaccine

:: COVID-19 Vaccine (Vero Cell), Inactivated-China National Biotec Group Company Limited
:: Evidence Assessment: Sinopharm/BBIBP COVID-19 vaccine
[Title and Summary Slide below]

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Draft landscape and tracker of COVID-19 candidate vaccines
7 May 2021 | Publication
The COVID-19 candidate vaccine landscape and tracker database compiles detailed information on COVID-19 vaccine candidates in development.
The landscape is updated regularly – twice a week (Tuesday and Friday, 17:00 CET).
Download: https://cdn.who.int/media/docs/default-source/blue-print/07.05.2021-novel-coronavirus_landscape_covid-19.xlsx.zip?sfvrsn=23955096_3&download=true

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Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 23 April 2021
For 19 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
[click on the link above for full scale view]
04 May 2021

COVID Vaccine Developer/Manufacturer Announcements [organizations from WHO EUL/PQ listing above]

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COVID Vaccine Developer/Manufacturer Announcements [organizations from WHO EUL/PQ listing above]

 

AstraZeneca
Press Releases – No new digest announcements identified

Bharat Biotech, India
Press Releases – No new digest announcements identified

BioCubaFarma – Cuba
Últimas Noticias – No new digest announcements identified

 

CanSinoBIO
News – No new digest announcements identified

Clover Biopharmaceuticals – China
News – No new digest announcements identified

 

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

 

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

IMBCAMS, China
Home – No new digest announcements identified

 

Janssen/JNJ
Press Releases
May 07, 2021
Access Arrangements for Janssen COVID-19 Vaccine
Johnson & Johnson is committed to enabling equitable global access to the Janssen COVID-19 vaccine on a not-for-profit basis for emergency pandemic use, pending local regulatory authorizations and direct procurement agreements with governments. In December 2020, the Company entered into an agreement in principle in support of COVAX, the global procurement mechanism for COVID-19 vaccines. We expect to enter into an Advance Purchase Agreement (APA) that would provide up to 500 million doses of the Janssen vaccine to COVAX through 2022.
At this time, the Company is only negotiating with government bodies and supranational organizations (e.g., European Commission, African Union, Gavi/COVAX) at a central level for vaccine procurement or purchase. We are not working with or through third parties for vaccine access during the current emergency pandemic period. National governments may reach out to us directly with any procurement questions by contacting: janssen_covid_vaccine_supply@its.jnj.com.
Johnson & Johnson recognizes the role of the private sector in addressing the pandemic and, at a future date, we will inform stakeholders when other options for vaccine procurement become available.

 

Moderna
Press Releases
May 6, 2021
Moderna Announces New Supply Agreement with Switzerland for 7 Million Booster Vaccine Doses in 2022 and Option for Additional 7 Million Doses

May 5, 2021
Moderna Announces Positive Initial Booster Data Against SARS-CoV-2 Variants of Concern

May 4, 2021
Moderna Announces Expansion of its Manufacturing Technology Center in Massachusetts

May 3, 2021
Moderna Announces Supply Agreement with Gavi for up to 500 Million Doses of COVID-19 Vaccine Moderna for COVAX To Help End COVID-19 Pandemic in Lowest Income Countries
:: 34 million doses to begin delivery in the fourth quarter of 2021
:: Option granted to COVAX Facility for up to 466 million additional doses in 2022
:: Doses provided at lowest tiered price, in keeping with Moderna’s global access principles commitment

 

Novavax
Press Releases
Novavax Statement in Opposition to the WTO TRIPS Waiver
5/7/2021 Statement

Novavax Statement on Ministry of Health, Labour and Welfare’s Announcement Regarding Procurement from Takeda of NVX-CoV2373 for Japan
5/7/2021 Statement
…Takeda is in the process of establishing vaccine procurement based on technology transfer by Novavax of NVXCoV2373, a recombinant protein vaccine candidate, and will be responsible for manufacturing and commercialization in Japan. Takeda will have the capability to manufacture 250 million doses yearly of the vaccine at its manufacturing site in Japan…

Novavax and Gavi Execute Advance Purchase Agreement for COVID-19 Vaccine for COVAX Facility
5/6/2021
:: Novavax to deliver 350 million doses beginning Q3 2021
:: 1.1 billion doses of Novavax vaccine to be available to countries participating in COVAX
:: Serum Institute of India to provide balance of doses for LMICs
:: Underscores commitment to global equitable access to Novavax vaccine

New England Journal of Medicine Publishes Phase 2b Clinical Trial Results Demonstrating Efficacy of Novavax COVID-19 Vaccine Against the B.1.351 Variant
5/63/2021

Novavax Initiates Pediatric Expansion for Phase 3 Clinical Trial of COVID-19 Vaccine
5/5/2021

 

Pfizer
Recent Press Releases
05.07.2021
Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency…

05.06.2021
Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at the 2020 Tokyo Games
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a Memorandum of Understanding (MoU) with the International Olympic Committee (IOC) to donate doses of the companies’ COVID-19 Vaccine to help vaccinate athletes, and their delegations, participating in the Olympic and Paralympic Games Tokyo 2020, which are scheduled to begin on July 23, 2021…

 

Serum Institute of India
NEWS & ANNOUNCEMENTS – No new digest announcements identified
[See Financial Times coverage in Media Watch below]

 

Sinopharm/WIBPBIBP
News – No new digest announcements identified

 

Sinovac
Press Releases – No new digest announcements identified
EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated
News 04/05/2021

 

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]

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 new digest content identified.

Advisory Committee on Immunization Practices (ACIP)
May 12, 2021 emergency meeting is a virtual meeting.
No registration is required.
Draft Agenda – May 12, 2021pdf icon Webcast Linkexternal icon
:: Pfizer COVID-19 Vaccine for 12-15 year old
:: Update on thrombosis with thrombocytopenia syndrome (TTS) following Janssen COVID-19 vaccine
:: VaST update
:: COVID-19 Vaccine Effectiveness studies
:: Update on emerging SARS-CoV-2 variants

 

::::::

White House [U.S.]
Briefing Room – Selected Major COVID Announcements
Press Briefing by White House COVID-19 Response Team and Public Health Officials
May 07, 2021 • Press Briefings

Press Briefing by White House COVID-19 Response Team and Public Health Officials
May 05, 2021 • Press Briefings

Remarks by President Biden on the COVID-19 Response and the Vaccination Program
May 04, 2021 • Speeches and Remarks

FACT SHEET: President Biden to Announce Goal to Administer at Least One Vaccine Shot to 70% of the U.S. Adult Population by July 4th
May 04, 2021 • Statements and Releases

 

::::::

COVID Data Tracker [U.S.] May 8, 2021

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: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021 (new)
PRAC, Last updated: 07/05/2021

News: EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19 (new)
CHMP, Last updated: 07/05/2021

News: International regulators and WHO call for wider public access to clinical data (new)
Last updated: 07/05/2021

News: Confidentiality arrangement between EU and Brazilian regulatory authorities (new)
Last updated: 06/05/2021

News: EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated (new)
CHMP, Last updated: 04/05/2021

News: EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15 (new)
CHMP, Last updated: 03/05/2021

 

European Commission
https://ec.europa.eu/commission/presscorner/home/en
News 8 May 2021
“The EU stands with India in times of need”: op-ed article by Ursula von der Leyen, President of the European Commission
“As soon as India requested support, the EU and its member states came together to help. We activated our EU civil protection mechanism in one of its biggest-ever response operations. This is what friends do in times of need.”

Press release 6 May 2021
Coronavirus: Commission proposes EU Strategy for the development and availability of therapeutics
The European Commission is today complementing the successful EU Vaccines Strategy with a strategy on COVID-19 therapeutics to support the development and availability of much-needed COVID-19 therapeutics, including for the treatment of ‘long COVID’.

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
Single dose vaccine, Sputnik Light, authorized for use in Russia
06.05.2021
Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of Sputnik V – the world’s first registered vaccine against coronavirus.
The single dose Sputnik Light vaccine demonstrated 79.4% efficacy according to analyzed data taken from 28 days after the injection was administered as part of Russia’s mass vaccination program between 5 December 2020 and 15 April 2021….

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

Milestones :: Perspectives :: Research

 

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

 

Government of India – Press Information Bureau
Latest Press Releases
PM praises the role of the armed forces in the fight against COVID-19
Posted on: 06 May 2021

PM Modi reviews public health response to Covid-19
Posted on: 06 May 2021

PM praises healthcare workers and nurses for reducing vaccine waste
Posted on: 05 May 2021

PM authorises keys decisions to boost availability of medical personnel to fight COVID-19
Posted on: 03 May 2021

 

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

 

 

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

POLIO Public Health Emergency of International Concern (PHEIC); WHO/OCHA Emergencies

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 05 May 2021
:: The GPEI has released a position statement on the United Kingdom’s proposed cuts to contributions toward polio eradication in 2021.
:: “Our ability to eradicate polio depends on our commitment to removing obstacles to women’s involvement in and ownership of eradication efforts. Women are at the forefront of the global struggle against polio – whether as caregivers, vaccinators, vaccine advocates and trusted leaders among affected populations, or as scientists, public health professionals and managers in the GPEI…”. Read more from our new Polio Gender Champion; Rochelle P. Walensky, MD, MPH Director, CDC, and Administrator, ATSDR.

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
:: Pakistan: two WPV1 positive environmental samples
:: Liberia: one cVDPV2 positive environmental sample
:: Senegal: one cVDPV2 case and one cVDPV2 positive environmental sample
:: South Sudan: one cVDPV2 case

::::::

GPEI statement on proposed UK aid cuts
As of 4 May 2021
The Global Polio Eradication Initiative (GPEI) is greatly concerned by the United Kingdom’s proposed cuts to contributions toward polio eradication in 2021. The proposed 95% reduction will result in an enormous setback to the eradication effort at a critical moment.

The UK has a long legacy as a leader in global health and its leadership in polio eradication, including financial contributions to the GPEI, have driven wild poliovirus out of all but two countries in the world. The GPEI values the UK government’s steadfast partnership and shared commitment to eradicating polio, and UK citizens have generously championed the drive to end polio. This has helped bring the world to the cusp of being polio-free, whilst providing an investment in broader public health capacity.

In 2019, the UK government pledged to help vaccinate more than 400 million children a year against polio and to support 20 million health workers and volunteers in this vital work. In addition to their life-saving work to end polio, these health workers have been in the frontline of the fight against COVID-19 and have helped some of the world’s most vulnerable countries protect their citizens. The UK’s ongoing support is needed to ensure that the polio infrastructure can continue supporting COVID-19 response efforts, while also resuming lifesaving immunization services against other deadly childhood diseases. In 2020, the UK government’s contributions ensured that the GPEI could continue to support outbreak response in 25 countries and conduct surveillance in nearly 50, all whilst strengthening health systems.  The continuation of such support will not be possible unless replacement funds are identified, and as such, this funding cut will have a potentially devastating impact on the polio eradication program.

The GPEI recognises the challenging economic circumstances faced by the UK government and a host of other countries. Governments worldwide are making critical investments in the health of their citizens, as well as evaluating global commitments. Cutting the UK government’s contributions by 95% will, however, put millions of children at increased risk of diseases such as polio and will weaken the ability of countries to detect and respond to outbreaks of polio and other infectious diseases, including COVID-19. Furthermore, it risks delaying polio eradication and the dismantling of one of the most effective disease surveillance and response networks at a time when the COVID-19 pandemic continues its devastation.

GPEI looks forward to working with the UK and the broader global community to address these urgent issues, which jeopardize the collective investment and progress toward a polio free world. Together we can end polio forever and ensure that polio infrastructure and its assets continue to strengthen preparedness and response and save lives.

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

WHO/OCHA Emergencies

Editor’s Note:
Continuing with this edition, we include information about the last apparent update evident on the WHO emergency country webpages, recognizing almost universal and significant interims since last update regardless of the level of the emergency listed.

WHO Grade 3 Emergencies [to 8 May 2021]

Democratic Republic of the Congo
:: 3 May 2021 News release
WHO Director-General congratulates the Democratic Republic of the Congo as 12th Ebola outbreak is declared over; stresses need to maintain vigilance to prevent virus’s return

Mozambique floods – No new digest announcements identified [Last apparent update: 3 November 2020]
Nigeria – No new digest announcements identified [Last apparent update: 29 Jun 2020]
Somalia – No new digest announcements identified [Last apparent update: 17 July 2020]
South Sudan – No new digest announcements identified [Last apparent update: 4 February 2020]
Syrian Arab Republic – No new digest announcements identified [Last apparent update: 24 October 2020]
Yemen – No new digest announcements identified [Last apparent update: 30 June 2020]

::::::

WHO Grade 2 Emergencies [to 8 May 2021]
Afghanistan – No new digest announcements identified [Last apparent update: 5 July 2020]
Angola – No new digest announcements identified [Last apparent update: 16 March 2021]
Burkina Faso – No new digest announcements identified [Last apparent update: 01 avril 2021]
Burundi – No new digest announcements identified [Last apparent update: 04 July 2019]
Cameroon – No new digest announcements identified [Last apparent update: 22 August 2019]
Central African Republic – No new digest announcements identified [Last apparent update: 12 June 2018]
Ethiopia – No new digest announcements identified [Last apparent update: 22 August 2019]
Iran floods 2019 – No new digest announcements identified [Last apparent update: 2 March 2020]
Iraq – No new digest announcements identified [Last apparent update: 26 April 2021]
Libya – No new digest announcements identified [Last apparent update: 7 October 2019]
Malawi – No new digest announcements identified [Last apparent update: 22 April 2021
Measles in Europe No new digest announcements identified [Last apparent update: 26-04-2021]
MERS-CoV – No new digest announcements identified [Last apparent update: 8 July 2019]
Mozambique – No new digest announcements identified [Last apparent update: 03 November 2020]
Myanmar – No new digest announcements identified [Last apparent update: 29 March 2021]
NigerNo new digest announcements identified [Last apparent update: 16 avril 2021]
occupied Palestinian territory – No new digest announcements identified [Last apparent update: 4 September 2019]
HIV in Pakistan – No new digest announcements identified [Last apparent update: 27 August 2019]
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements
Sudan – No new digest announcements identified [Last apparent update: 24 June 2020]
Ukraine – No new digest announcements identified [Last apparent update: 1 May 2019]
Zimbabwe – No new digest announcements identified [Last apparent update: 10 May 2019]

::::::

WHO Grade 1 Emergencies [to 8 May 2021]

Chad – No new digest announcements identified [Last apparent update: 30 June 2018]
Djibouti – No new digest announcements identified [Last apparent update: 25 novembre 2020]
Kenya – No new digest announcements identified [Last apparent update: 23 April 2021
Mali – No new digest announcements identified [Last apparent update: 3 May 2017]
Namibia – viral hepatitis – No new digest announcements identified [Last apparent update: 20 July 2018]
Tanzania – No new digest announcements identified [Last apparent update: 21 October 2019]

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

UN OCHA – Current Emergencies
Current Corporate Emergencies
Ethiopia – Tigray Region Humanitarian Update Situation Report, 6 May 2021
HIGHLIGHTS
:: Active hostilities remain the main access impediment for scaling up response in rural areas in addition to constrained communications
:: Humanitarian partners are scaling up response but can only fully implement with access constraints addressed
:: Three food operators have distributed more than 19,000 metric tons of food for the first round of assistance for 2021, reaching 1.1 million people across the region
:: COVID-19 screening started in all targeted 15 health facilities in Mekelle At least US$443 million have been allocated to respond to the crisis but more is needed particularly for non-food assistance

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

WHO & Regional Offices [to 8 May 2021]

WHO & Regional Offices [to 8 May 2021]
https://www.who.int/

7 May 2021 News release
WHO lists additional COVID-19 vaccine for emergency use and issues interim policy recommendations

7 May 2021 Statement
Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO

7 May 2021 Departmental news
First deployment of WHO emergency rehabilitation support

7 May 2021 Departmental news
Development of updated WHO guidelines on the management of tuberculosis in children and adolescents

6 May 2021 News release
Global experts of new WHO Council on the Economics of Health For All announced

6 May 2021 Departmental news
The UNICEF/WHO/WB Joint Child Malnutrition Estimates (JME) group released new data for 2021

6 May 2021 Departmental news
The Partnership for Healthy Cities supports COVID-19 Vaccine Outreach in 18 Cities

5 May 2021 News release
WHO Director-General commends United States decision to support temporary waiver on intellectual property rights for COVID-19 vaccines

5 May 2021 Joint News Release
WHO, Germany launch new global hub for pandemic and epidemic intelligence

5 May 2021 Departmental news
WHO calls for better hand hygiene and other infection control practices

5 May 2021 Departmental news
Updated WHO Information Note: Ensuring continuity of TB services during the COVID-19 pandemic

5 May 2021 News release
New WHO benchmarks help countries reduce salt intake and save lives

5 May 2021 Departmental news
WHO launches new platform for knowledge exchange on dementia

4 May 2021 Departmental news
WHO and UN Global Pulse are building a social listening radio tool to aid the COVID-19 infodemic response

4 May 2021 Departmental news
Why we need to focus on quality care for women and newborns

3 May 2021 Departmental news
Expanding reach: Addressing gender barriers in COVID-19 vaccine rollout

3 May 2021 News release
WHO welcomes Sweden’s announcement to share COVID-19 vaccine doses with COVAX

3 May 2021 News release
WHO Director-General congratulates the Democratic Republic of the Congo as 12th Ebola outbreak is declared over; stresses need to maintain vigilance to prevent virus’s return

3 May 2021 Departmental news
Affordability of WASH must be defined and tracked if 2030 Global Goals are to be met: new report

3 May 2021 Departmental news
Oral rabies vaccine: a new strategy in the fight against rabies deaths

 

::::::

Weekly Epidemiological Record, Vol. 96, No. 18, pp. 145–156 7 May 2021
:: Surveillance to track progress towards polio eradication – worldwide, 2019–2020 Surveillance to track progress towards polio eradication – worldwide, 2019–2020

 

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
No new digest content identified

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
:: Countries across Europe send life-saving goods to help India’s fight against COVID-19 07-05-2021
:: WHO/Europe launches new guidance to make hand washing easier 05-05-2021

WHO Eastern Mediterranean Region EMRO
:: Pakistan receives first consignment of COVID-19 vaccines via COVAX Facility 8 May 2021
…Today Pakistan received its first shipment of Oxford-AstraZeneca COVID-19 vaccines (SII-AZ AZD1222) from the COVAX Facility. The consignment of 1 238 400 doses of vaccines, which will be followed by another of 1 236 000 in a few days, will support the Government of Pakistan’s ongoing historic drive.

WHO Western Pacific Region
No new digest content identified

CDC/ACIP [U.S.] [to 8 May 2021]

CDC/ACIP [U.S.] [to 8 May 2021]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
CDC Issues Phases 2B and 3 of the Conditional Sailing Order
Wednesday, May 5, 2021

CDC Principal Deputy Director Named 2021 Service to America Medal
Monday, May 3, 2021
The Centers for Disease Control and Prevention’s Principal Deputy Director Anne Schuchat, MD (RADM, USPHS, RET), has been named a finalist in the Partnership for Public Service’s 2021 Service to America Medals, known as the “Sammies.” Dr. Schuchat is a finalist in the Paul A. Volcker Career Achievement Category that recognizes a federal employee for leading significant and sustained accomplishments throughout a federal career of 20 or more years.
The Sammies are government-wide awards that recognize the talents and achievements of outstanding federal employees.
“Over her 33-year CDC career, Dr. Schuchat has led some of the highest profile and most consequential outbreak investigations and responses in the agency’s history,” said CDC Director Rochelle P. Walensky, MD, MPH. “As the CDC principal deputy director and highest-ranking permanent employee of the agency since 2015, she has been an extraordinary leader and a steady hand at the wheel during a tumultuous era for the agency, including the current challenges presented by the COVID-19 pandemic.”…

Ebola Outbreak Over in the Democratic Republic of the Congo
Monday, May 3, 2021

MMWR News Synopsis Friday, April 30, 2021

MMWR News Synopsis Friday, April 30, 2021
:: COVID-19 Outbreak Among Farmworkers — Okanogan County, Washington, May–August 2020
:: COVID-19 Among Workers in the Seafood Processing Industry: Implications for Prevention Measures — Alaska, March–October 2020
:: Linked Clusters of SARS-CoV-2 Variant B.1.351 — Maryland, January–February 2021
:: Postvaccination SARS-CoV-2 Infections Among Skilled Nursing Facility Residents and Staff Members — Chicago, Illinois, December 2020–March 2021 (Early Release April 21, 2021)
:: COVID-19 Outbreak Associated with a SARS-CoV-2 R.1 Lineage Variant in a Skilled Nursing Facility After Vaccination Program — Kentucky, March 2021 (Early Release April 21, 2021)
:: Health Care Utilization and Clinical Characteristics of Nonhospitalized Adults in an Integrated Health Care System 28–180 Days After COVID-19 Diagnosis — Georgia, May 2020–March 2021 (Early Release April 23, 2021)
:: Updated Recommendations from the Advisory Committee on Immunization Practices for Use of Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients — United States, April 2021 (Early Release April 27, 2021)

Coronavirus Disease 2019 (COVID-19)- CDC

Coronavirus Disease 2019 (COVID-19)– CDC
Selected Resources
Overall US COVID-19 Vaccine Distribution and Administration Update as of Fri, 07 May 2021 06:00:00 EST

5/7/21
Scientific Brief: SARS-CoV-2 Transmission
:: This science brief has been updated to reflect current knowledge about SARS-CoV-2 transmission and reformatted to be more concise.
:: Modes of SARS-CoV-2 transmission are now categorized as inhalation of virus, deposition of virus on exposed mucous membranes, and touching mucous membranes with soiled hands contaminated with virus.
:: Although how we understand transmission occurs has shifted, the ways to prevent infection with this virus have not. All prevention measures that CDC recommends remain effective for these forms of transmission.
Transmission of SARS-CoV-2 from inhalation of virus in the air farther than six feet from an infectious source can occur
With increasing distance from the source, the role of inhalation likewise increases. Although infections through inhalation at distances greater than six feet from an infectious source are less likely than at closer distances, the phenomenon has been repeatedly documented under certain preventable circumstances.10-21 These transmission events have involved the presence of an infectious person exhaling virus indoors for an extended time (more than 15 minutes and in some cases hours) leading to virus concentrations in the air space sufficient to transmit infections to people more than 6 feet away, and in some cases to people who have passed through that space soon after the infectious person left. Per published reports, factors that increase the risk of SARS-CoV-2 infection under these circumstances include:
:: Enclosed spaces with inadequate ventilation or air handling within which the concentration of exhaled respiratory fluids, especially very fine droplets and aerosol particles, can build-up in the air space.
:: Increased exhalation of respiratory fluids if the infectious person is engaged in physical exertion or raises their voice (e.g., exercising, shouting, singing).
:: Prolonged exposure to these conditions, typically more than 15 minutes.

China CDC

China CDC
http://www.chinacdc.cn/en/
China CDC Weekly
Vol. 3 No. 19 May 7, 2021

National Health Commission of the People’s Republic of China [to 8 May 2021]
http://en.nhc.gov.cn/
News
May 8: Daily briefing on novel coronavirus cases in China
On May 7, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 7 new cases of confirmed infections.

China-donated COVID-19 vaccines arrive in Myanmar
2021-05-06

National Medical Products Administration – PRC [to 8 May 2021]
http://english.nmpa.gov.cn/news.html
News
WHO approves China’s Sinopharm vaccine for emergency use
2021-05-08
The World Health Organization announced on May 7 it will give emergency use authorization to the COVID-19 vaccine manufactured by China’s Sinopharm.

Over 297m COVID-19 vaccine doses administered across China
2021-05-08
More than 297.7 million doses of COVID-19 vaccines had been administered across China as of Thursday, the National Health Commission said on May 7.

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 8 May 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
Kathy Richmond | Science in Sixty
May 5, 2021
Kathryn Richmond, Senior Director of The Paul G. Allen Frontiers Group, is looking for the best ideas out there to change how we think about biology and accelerate discovery.

 

BARDA – U.S. Department of HHS [to 8 May 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
News
No new digest content identified.

 

BMGF – Gates Foundation [to 8 May 2021]
https://www.gatesfoundation.org/ideas/media-center
Press Releases and Statements
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 8 May 2021]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

 

CARB-X [to 8 May 2021]
https://carb-x.org/
News
No new digest content identified.

 

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 8 May 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
:: Past weekly editions and posting of all segments of Vaccines and Global Health: The Week in Review are available here.
:: [NEW] Informed Consent: A Monthly Review – May 2021 is now posted here

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 8 May 2021]
http://cepi.net/
Latest News
CEPI and Dynavax expand collaboration to increase supply of adjuvant for COVID-19 vaccines
7 May 2021, Oslo, Norway – CEPI, the Coalition for Epidemic Preparedness Innovations, today announced an expanded agreement with Dynavax Technologies Corporation (Nasdaq: DVAX) to increase the supply of Dynavax’s CpG 1018 vaccine adjuvant available for CEPI-funded COVID-19 vaccine development programmes in 2021. This builds upon an initial agreement signed in January 2021 which provided Dynavax up to $99 million to advance the at-risk manufacture of CpG 1018.
Under the terms of the expanded agreement, CEPI will increase funding by $77 million to a total of $176 million which will increase the available volume of CpG 1018 in 2021. The funding is in the form of a forgivable loan which is repayable to CEPI upon adjuvant sales.
The adjuvant produced under this agreement will be first offered for purchase by CEPI’s vaccine development partners within price parameters agreed with CEPI, and represents a key strategic investment by CEPI to increase overall availability of vaccine doses in 2021 from CEPI’s COVID-19 R&D portfolio.
It is anticipated that vaccine developers benefiting from CpG 1018 produced under this agreement will make vaccine output – potentially hundreds of millions of doses in 2021 – available for procurement and allocation through COVAX. COVAX is the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income level.

 

DARPA – Defense Advanced Research Projects Agency [to 8 May 2021
https://www.darpa.mil/news
News
5/3/2021
Creating AI-Enabled Cultural Interpreters to Aid Defense Operations
[See Week in Review above for detail]

 

Duke Global Health Innovation Center [to 8 May 2021]
https://dukeghic.org/
WEEKLY COVID VACCINE RESEARCH UPDATE
Last dated update: FRIDAY, April 16, 2021

 

EDCTP [to 8 May 2021]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
04 May 2021
New support tools for TB vaccine R&D published
The Tuberculosis Vaccine Initiative (TBVI) has coordinated the development of several new tools to support future TB vaccine clinical trials. Experts in the field together with researchers from the ongoing EDCTP-funded TB vaccine projects developed templates and guidelines. These are to support preparations for a regulatory plan, a data management plan and clinical trial protocol synopses. Furthermore, a comprehensive registry of trial sites in sub-Saharan Africa with capacities to conduct TB vaccine studies has been made available online. EDCTP supported TBVI with an investment of €130,000…

 

Emory Vaccine Center [to 8 May 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Vaccine Initiative [to 8 May 2021]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 8 May 2021]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
May 7, 2021 – Coronavirus (COVID-19) Update: May 7, 2021

May 5, 2021 – Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations

May 4, 2021 – Coronavirus (COVID-19) Update: May 4, 2021

 

Fondation Merieux [to 8 May 2021]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation co-organized event
Evidence to actions: countries and communities driving adaptive, evidence-informed approaches to end cholera
May 20, 2021 – Virtual Event

 

Gavi [to 8 May 2021]
https://www.gavi.org/
News Releases
6 May 2021
Gavi signs agreement with Novavax to secure doses on behalf of COVAX Facility
:: The signed advance purchase agreement (APA) is for a commitment to purchase 350 million doses of the Novavax vaccine candidate
:: Deliveries will commence in Q3 2021, upon regulatory approval
:: Doses supply self-financing participants of the COVAX Facility as well as lower-income economies eligible for donor-funded vaccines through the Gavi COVAX Advance market Commitment (AMC)

 

GHIT Fund [to 8 May 2021]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
No new digest content identified.

 

Global Fund [to 8 May 2021]
https://www.theglobalfund.org/en/news/
News & Stories
News
Global Fund Approves US$75 million for India’s COVID-19 Response
06 May 2021
The Global Fund has approved US$75 million in fast-track funding to support India’s response to the COVID-19 crisis that is devastating the country. This new funding will support India in purchasing oxygen concentrators and Pressure Swing Adsorption (PSA) oxygen plants to help meet the medium-term needs for medical oxygen.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 8 May 2021]
https://www.glopid-r.org/news/
News
Global COVID-19 research agenda still missing the priorities of low- and middle-income countries
07/05/2021
An article published today in The Lancet calls for urgent collaboration and coordination for unmet, underfunded COVID-19 research priorities in low-resource settings.

 

Hilleman Laboratories [to 8 May 2021]
http://www.hillemanlabs.org/
Website not responding at inquiry

 

Human Vaccines Project [to 8 May 2021]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
[Website not fully loading at inquiry]

 

IAVI [to 8 May 2021]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
No new digest content identified.

 

 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
Joint Statement on transparency and data integrity – International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO)
7 May 2021
[See Milestones above for detail]

 

ICRC [to 8 May 2021]
https://www.icrc.org/en/whats-new
Selected News Releases, Statements, Reports
International Humanitarian Law Bibliography
The ICRC International Humanitarian Law Bibliography lists references to English and French publications on international humanitarian law.
06-05-2021 | Article

Multilateralism plays an important role in alleviating suffering and creating conditions for peace
Statement by the International Committee of the Red Cross, delivered by Laetitia Courtois, Permanent Observer, to Interactive Dialogue to commemorate and promote the International Day of Multilateralism and Diplomacy for Peace.
05-05-2021 | Statement

ICRC response to COVID-19: Near and Middle East
A YEAR OF LOSS, DISRUPTION, SOLIDARITY AND HOPE One year on since the outbreak of the COVID-19 pandemic, this newsletter provides an overview of the ICRC response across the Near and Middle East and illustrates how, despite many additional challenges
05-05-2021 | Report

 

 

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 8 May 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Bangladesh, India, Nepal, Pakistan
South Asia: Urgent action needed to prevent further human catastrophe
Kuala Lumpur/Kathmandu/Delhi/Geneva, 5 May 2021 – Urgent international support is needed to prevent a worsening human catastrophe in countries across South Asia as India’s total COVID-19 infections soar past 20 million.
5 May 2021

 

Institut Pasteur [to 8 May 2021]
https://www.pasteur.fr/en/press-area
Press release
07.05.2021
Christine Petit co-recipient of the 2021 Gruber Neuroscience Prize
…The 2021 Gruber Neuroscience Prize is being awarded to neuroscientists Christine Petit, MD, PhD, of the Institut Pasteur (joint research unit Inserm), the French Academy of Sciences and Collège de France, and, and Christopher A. Walsh, MD, PhD, of Harvard Medical School and Boston Children’s Hospital, for their groundbreaking work in revealing the genetic and molecular mechanisms behind the development of inherited neurodevelopmental disorders and with a profound impact on our understanding of how the brain functions, both in health and disease.
Christine Petit is receiving the award for her seminal contributions to the understanding of the mechanisms involved with hearing and hearing loss.
The Gruber Neuroscience Prize, which includes a $500,000 award and a gold medal will be presented to Christine Petit and Christopher A. Walsh in November at the annual meeting of the Society for Neuroscience.

 

IOM / International Organization for Migration [to 8 May 2021]
http://www.iom.int/press-room/press-releases
News
World Migration Report Launches Dynamic New Data Visualization Platform
2021-05-05 15:53
Geneva – The International Organization for Migration’s (IOM) flagship publication has launched a dynamic new webpage that connects fact-based narratives on migration with interactive data visualizations on…

800,000 South Sudanese May Face Reduced Access to Life-Saving Primary Health Care by June, IOM Warns
2021-05-04 14:21
Juba – The International Organization for Migration (IOM) warns that more than 800,000 people in South Sudan who rely on IOM for their health care may face reduced access to life-saving services by June if urgent calls for humanitarian funding are not met.

 

IRC International Rescue Committee [to 8 May 2021]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
No new digest content identified.

 

IVAC [to 8 May 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

 

IVI [to 8 May 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

 

JEE Alliance [to 8 May 2021]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

Johns Hopkins Center for Health Security [to 8 May 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 8 May 2021]
http://www.msf.org/
Latest [Selected Announcements
No new digest content identified.

 

National Academy of Medicine – USA [to 8 May 2021]
https://nam.edu/programs/
Selected News/Programs
Upcoming Events:
May 18 2021
International Workshop on COVID-19 Lessons to Inform Pandemic Influenza Response, Day 1: Global Coordination
Time: 7:00 AM
This global public workshop will convene international experts, thought-leaders, and other stakeholders to discuss the emerging evidence on these unprecedented actions related to COVID-19 that could inform and advance pandemic and seasonal influenza vaccine preparedness efforts and subsequent response.

May 21 2021
International Workshop on COVID-19 Lessons to Inform Pandemic Influenza Response, Day 2: Supply Chain Cascade
Time: 8:30 AM
This global public workshop will convene international experts, thought-leaders, and other stakeholders to discuss the emerging evidence on these unprecedented actions related to COVID-19 that could inform and advance pandemic and seasonal influenza vaccine preparedness efforts and subsequent response.

May 25 2021
International Workshop on COVID-19 Lessons to Inform Pandemic Influenza Response, Day 3: Lessons Learned Across Fields
Time: 8:30 AM
This global public workshop will convene international experts, thought-leaders, and other stakeholders to discuss the emerging evidence on these unprecedented actions related to COVID-19 that could inform and advance pandemic and seasonal influenza vaccine preparedness efforts and subsequent response.

 

National Vaccine Program Office – U.S. HHS [to 8 May 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

 

NIH [to 8 May 2021]
http://www.nih.gov/news-events/news-releases
News Releases
No new digest content identified.

 

UN OCHA Office for the Coordination of Humanitarian Affairs [to 8 May 2021]
https://www.unocha.org/
Press Releases
No new digest content identified.

 

PATH [to 8 May 2021]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

 

Sabin Vaccine Institute [to 8 May 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
Vaccine Science and Policy Experts Call for Transformation of Vaccine R&D Enterprise
Tuesday, May 4, 2021
[See Milestones above for detail]

 

UNAIDS [to 8 May 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
7 May 2021
Pioneers of the harm reduction response in Uganda

6 May 2021
Specialized medical waste management equipment for Republic of Moldova’s harm reduction programme

5 May 2021
UNAIDS Executive Director visits projects in Namibia that empower adolescent girls and young women

5 May 2021
UNITY Platform publishes annual report on violence against sexual and gender minorities in Cameroon

4 May 2021
UNAIDS is saddened by the death of Patrick O’Connell, the founding director of Visual AIDS

4 May 2021
100% Life: 20 years of fighting

3 May 2021
Big drops in the cost of antiretroviral medicines, but COVID-19 threatens further reductions

 

UNDP United Nations Development Programme [to 8 May 2021]
http://www.undp.org/content/undp/en/home/presscenter.html
Latest from News Centre
No new digest content identified.

 

UNHCR Office of the United Nations High Commissioner for Refugees [to 8 May 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected News Releases, Announcements
Pandemic threatens progress on refugee admissions through family, work, study permits
5 May 2021
A new study released today shows that 1.5 million people from nations driving major refugee movements were admitted by 35 OECD countries and Brazil on family, work and study permits in the decade just prior to the COVID-19 pandemic.
The latest report by UNHCR, the UN Refugee Agency, and the OECD, the Organisation for Economic Co-operation and Development , titled “Safe Pathways for Refugees II”, examines admissions from 2010 to 2019 of people from seven countries propelling displacement: Afghanistan, Eritrea, Iran, Iraq, Somalia, Syria and Venezuela…

 

UNICEF [to 8 May 2021]
https://www.unicef.org/media/press-releases
Selected Press Releases, Statements
Press release
05/07/2021
Geneva Palais briefing note on the impact of the deadly COVID-19 surge on children in India, and increasingly in the region
This is a summary of what was said by UNICEF representative Dr Yasmin Ali Haque – to whom quoted text may be attributed – at today’s press briefing at the Palais des Nations in Geneva.
… “UNICEF is very concerned about this deadly daily surge in new cases. This wave is almost four times the size of the first wave and the virus is spreading much faster.  On an average there were more than four new cases every second and more than two deaths every minute in last 24 hours. With the surge in cases, the virus is also affecting more people across age groups including children and infants.
“What is happening in India should raise alarm bells for all of us. The pandemic is far from over. COVID-19 cases are rising at an alarming rate across South Asia, especially in Nepal, Sri Lanka and the Maldives. Entire health systems could collapse, leading to more tragic loss of life. Very low levels of vaccination in most South Asian countries (less than 10% in India, Sri Lanka and Nepal) is adding to concern of the virus spiraling even further. Besides South Asia, we are also seeing alarming situations in other parts of the world.
“Along with the increase in COVID-19 cases, the impact on children being affected by the virus has also increased.  And of course the impact of the outbreak and public health and social measures on children is likely to be aggravated following the second wave. They are living through a tragedy…

Press release
05/05/2021
United States renews longstanding commitment to UNICEF with $300 million pledge for improving the lives of mothers and children

News note
05/05/2021
Canada becomes first country to support COVID-19 therapeutics via new UNICEF fund
Low- and middle-income countries set to benefit from Canadian contribution in support of global equitable access to lifesaving COVID-19 medical supplies

News note
05/04/2021
UNICEF, with support from DP World, sends critical supplies to help fight COVID-19 surge in India

Statement
05/04/2021
Deadly new surge in South Asia threatens to reverse global gains against the COVID-19 pandemic and have disproportionate impact on children
Statement by George Laryea-Adjei, UNICEF Regional Director for South Asia

 

Unitaid [to 8 May 2021]
https://unitaid.org/
Featured News
06 May 2021
Unitaid statement on US support for IP waiver for COVID-19 vaccines
[See COVID – TRIPS – IP above for detail]

 

Vaccination Acceptance Research Network (VARN) [to 8 May 2021]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 8 May 2021]
http://www.vaccineconfidence.org/
News, Research and Reports
Coronavirus global impact
Launched April 2, 2020 and recurring every 3 days, Premise Data is utilizing its global network of Contributors to assess economic, social, and health sentiment surrounding the coronavirus (COVID-19).

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 8 May 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

 

Wellcome Trust [to 8 May 2021]
https://wellcome.ac.uk/news
News and reports
Explainer
What are human infection studies and why do we need them?
5 May 2021
Human infection studies (also known as human challenge trials and controlled human infection models) have the power to rapidly accelerate the development of much-needed vaccines and treatments, including for Covid-19.

 

The Wistar Institute [to 8 May 2021]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

 

WFPHA: World Federation of Public Health Associations [to 8 May 2021]
https://www.wfpha.org/
Latest News
Public Health Leadership Coalition: Global Launch
News May 7, 2021
The COVID-19 pandemic has underlined how a focused and organised public health effort is imperative to fight global crises effectively.
The Public Health Leadership Coalition is taking the responsibility of being a strong, independent and accountable voice of public health workforce, communities, civil societies, and scientific experts to make governments and organizations accountable for their choices.
Coalition leaders will provide scientific advice and effective solutions to enable decision-makers to implement the best evidence-based policies in public health and to make the right choice for the health and wealth of each country.
On 12 May, join the official launch of the Public Health Leadership Coalition to learn more about the Coalition’s values and aims. Save your spot by clicking on the link below.
Register Here

 

World Bank [to 8 May 2021]
http://www.worldbank.org/en/news/all
Selected News, Announcements
Key Facts: World Bank Group Vaccine Announcement
COVID-19 vaccines, alongside widespread testing, improved treatment and strong health systems are critical to save lives and strengthen the global economic recovery. To provide relief for vulnerable populations…
Date: May 03, 2021 Type: Factsheet

 

World Customs Organization – WCO [to 8 May 2021]
http://www.wcoomd.org/
Latest News – Selected Items
No new digest content identified.

 

World Organisation for Animal Health (OIE) [to 8 May 2021]
https://www.oie.int/en/for-the-media/press-releases/2021/
Press Releases
No new digest content identified.

 

WTO – World Trade Organisation [to 8 May 2021]
http://www.wto.org/english/news_e/news_e.htm
WTO News and Events
Webinar to explore links between TRIPS and health technology dissemination
7 May 2021
A panel of leading experts will explore on 12 May the impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on health technology diffusion over the past 25 years and its role in the broader ecosystem that is required to support innovation and equitable access to medical technologies. The webinar “Trade and Public Health: Dissemination of Health Technologies” forms part of a series of events to mark the 25th anniversary of the TRIPS Agreement.
The webinar is an integral part of the “Virtual Course on Trade and Public Health with a Special Focus on the COVID-19 Pandemic” and is open to the public.  It will take place on 12 May 2021, from 14:00 to 16:30 (CET).
Registration for the webinar is available here.
The full programme of the event is available here.
The event will be live streamed through the WTO YouTube channel.

Statement of Director-General Ngozi Okonjo-Iweala on USTR Tai’s statement on the TRIPS waiver
6 May 2021
“I read with interest the statement made yesterday by USTR Katherine Tai and I warmly welcome her willingness to engage with proponents of a temporary waiver of the TRIPS Agreement to help in combatting the COVID-19 pandemic. As I told the General Council yesterday, we need to respond urgently to COVID-19 because the world is watching and people are dying. I am pleased that the proponents are preparing a revision to their proposal and I urge them to put this on the table as soon as possible so that text-based negotiations can commence. It is only by sitting down together that we will find a pragmatic way forward — acceptable to all members — which enhances developing countries’ access to vaccines while protecting and sustaining the research and innovation so vital to the production of these life-saving vaccines.”

General Council – Remarks by DG Okonjo-Iweala on the IP waiver
5 May 2021
Speech

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 8 May 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Press Releases
No new digest content identified.

 

BIO [to 8 May 2021]
https://www.bio.org/press-releases
Press Releases
Support of “TRIPS” Waiver Sets Dangerous Precedent
May 5, 2021
Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), released the following statement in response to the White House’s support of waiving critical intellectual property rights for COVID-19…
…”Handing needy countries a recipe book without the ingredients, safeguards, and sizable workforce needed will not help people waiting for the vaccine. Handing them the blueprint to construct a kitchen that – in optimal conditions – can take a year to build will not help us stop the emergence of dangerous new COVID variants. The better alternative would have been to follow through on the President’s pledge just last week to make the United States the world’s “arsenal of vaccines”.  This policy leads in the opposite direction….

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 8 May 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 8 May 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 8 May 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA Response on Joint Statement on transparency and data integrity by International Coalition of Medicines
Geneva, 7 May 2021
[See Milestones above for detail]

IFPMA Statement on WTO TRIPS Intellectual Property Waiver
05 May 2021
[See COVID – TRIPS – IP above for detail]

 

PhRMA [to 8 May 2021]
http://www.phrma.org/
Selected Press Releases, Statements
PhRMA CAREs Grant request for proposals: Addressing inequities in access to COVID-19 testing, therapeutics and vaccines
May 6, 2021
PhRMA CAREs Grant request for proposals: Addressing inequities in access to COVID-19 testing, therapeutics, and vaccines
Blog Post

PhRMA Statement on WTO TRIPS Intellectual Property Waiver
May 5, 2021
Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl made the following statement after the United States Trade Representative expressed support for a proposal to waive patent protections for COVID-19 medicines.
Press release
[See COVID – TRIPS – IP above for detail]

A conversation with Ron Busby, Sr., President and CEO of the U.S. Black Chambers, Inc. on improving vaccine confidence in communities of color
May 5, 2021
A conversation with Ron Busby, Sr., President and CEO of the U.S. Black Chambers, Inc. on improving vaccine confidence in communities of color
Blog Post

Journal Watch

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

Ending the HIV Epidemic

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

 

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

Knowledge and preparedness of healthcare providers towards bioterrorism

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 8 May 2021)

 

Knowledge and preparedness of healthcare providers towards bioterrorism
Several emergent circumstances require healthcare providers to recognize the unusual and dangerous and pathogenic agents. An in-depth literature review showed that studies about bioterrorism preparedness among…
Authors: Abdullah Nofal, Isamme AlFayyad, Nawfal AlJerian, Jalal Alowais, Meshal AlMarshady, Anas Khan, Humariya Heena, Ayah Sulaiman AlSarheed and Amani Abu-Shaheen
Citation: BMC Health Services Research 2021 21:426
Content type: Research article
Published on: 5 May 2021

Self-management interventions for adolescents living with HIV: a systematic review

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 8 May 2021)

 

Self-management interventions for adolescents living with HIV: a systematic review
Self-management interventions aim to enable people living with chronic conditions to increase control over their condition in order to achieve optimal health and may be pertinent for young people with chronic …
Authors: Talitha Crowley and Anke Rohwer
Citation: BMC Infectious Diseases 2021 21:431
Content type: Research
Published on: 7 May 2021

Evaluation of the effectiveness and safety of adding ivermectin to treatment in severe COVID-19 patients

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 8 May 2021)

 

Evaluation of the effectiveness and safety of adding ivermectin to treatment in severe COVID-19 patients
An effective treatment option is not yet available for SARS-CoV2, which causes the COVID-19 pandemic and whose effects are felt more and more every day. Ivermectin is among the drugs whose effectiveness in tre…
Authors: Nurullah Okumuş, Neşe Demirtürk, Rıza Aytaç Çetinkaya, Rahmet Güner, İsmail Yaşar Avcı, Semiha Orhan, Petek Konya, Bengü Şaylan, Ayşegül Karalezli, Levent Yamanel, Bircan Kayaaslan, Gülden Yılmaz, Ümit Savaşçı, Fatma Eser and Gürhan Taşkın
Citation: BMC Infectious Diseases 2021 21:411
Content type: Research
Published on: 4 May 2021

The Socioecological Model as a framework for exploring factors influencing childhood immunization uptake in Lagos state, Nigeria

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 8 May 2021)

 

The Socioecological Model as a framework for exploring factors influencing childhood immunization uptake in Lagos state, Nigeria
Nigeria is one of the ten countries globally that account for 62% of under- and unvaccinated children worldwide. Despite several governmental and non-governmental agencies’ interventions, Nigeria has yet to ac…
Authors: Abisola Olaniyan, Chinwoke Isiguzo and Mary Hawk
Citation: BMC Public Health 2021 21:867
Content type: Research
Published on: 5 May 2021

Time trends in HPV vaccination according to country background: a nationwide register-based study among girls in Norway

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 8 May 2021)

 

Time trends in HPV vaccination according to country background: a nationwide register-based study among girls in Norway
Since the human papillomavirus (HPV) vaccine was introduced in Norway in 2009, the vaccine uptake has increased. Whether this increase is similar regardless of the girls’ country background is unknown. We exam…
Authors: Randi Dalene Bjerke, Ida Laake, Berit Feiring, Geir Aamodt and Lill Trogstad
Citation: BMC Public Health 2021 21:854
Content type: Research article
Published on: 3 May 2021

Gaps in health security related to wildlife and environment affecting pandemic prevention and preparedness, 2007–2020

Bulletin of the World Health Organization
Volume 99, Number 5, May 2021, 321-404
https://www.who.int/bulletin/volumes/99/5/en/

 

RESEARCH
Gaps in health security related to wildlife and environment affecting pandemic prevention and preparedness, 2007–2020
— Catherine Machalaba, Marcela Uhart, Marie-Pierre Ryser-Degiorgis & William B Karesh
http://dx.doi.org/10.2471/BLT.20.272690

Violence against healthcare in conflict: a systematic review of the literature and agenda for future research

Conflict and Health
http://www.conflictandhealth.com/
[Accessed 8 May 2021]

 

Violence against healthcare in conflict: a systematic review of the literature and agenda for future research
Attacks on health care in armed conflict, including those on health workers, facilities, patients and transports, represent serious violations of human rights and international humanitarian law. Information ab…
Authors: Rohini J. Haar, Róisín Read, Larissa Fast, Karl Blanchet, Stephanie Rinaldi, Bertrand Taithe, Christina Wille and Leonard S. Rubenstein
Citation: Conflict and Health 2021 15:37
Content type: Review
Published on: 7 May 2021

Strength is in engagement: The rise of an online scientific community during the COVID‐19 pandemic

EMBO Reports
Volume 22 Issue 5 5 May 2021
https://www.embopress.org/toc/14693178/current

 

Science & Society 5 May 2021 Open Access
Strength is in engagement: The rise of an online scientific community during the COVID‐19 pandemic
Christine E Cucinotta, Benjamin J E Martin, Melvin Noé González, Pravrutha Raman, Vladimir B Teif, Hanneke Vlaming
Many scientists, confined to home office by COVID‐19, have been gathering in online communities, which could become viable alternatives to physical meetings and conferences.

Latin American forum on immunization services during the COVID-19 pandemic

Expert Review of Vaccines
Vol 20 (3) 2021
https://www.tandfonline.com/toc/ierv20/current

 

Article
Latin American forum on immunization services during the COVID-19 pandemic
María L. Ávila-Agüero, Sebastián Ospina-Henao, María C. Pirez, Ángela Gentile, Soraya Araya, José Brea, Lourdes Mendoza & Luiza H. Falleiros-Arlant
Pages: 231-234
Published online: 20 Feb 2021

Disability inclusion in humanitarian action

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

 

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

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

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

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

JAMA
Online First

 

May 6, 2021
Original Investigation
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
JAMA. Published online May 6, 2021. 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
Online First

 

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
JAMA. Published online May 6, 2021. 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.
May 5, 2021

Antibody Response to 2-Dose SARS-CoV-2 mRNA Vaccine Series in Solid Organ Transplant Recipients

JAMA
May 4, 2021, Vol 325, No. 17, Pages 1703-1804
https://jamanetwork.com/journals/jama/currentissue

 

Research Letter
Antibody Response to 2-Dose SARS-CoV-2 mRNA Vaccine Series in Solid Organ Transplant Recipients
Brian J. Boyarsky, MD, PhD; William A. Werbel, MD; Robin K. Avery, MD; et al.
free access
JAMA. Published online May 5, 2021. doi:10.1001/jama.2021.7489
This follow-up study measures the antibody response following the second dose of SARS-CoV-2 mRNA vaccine in recipients of solid organ transplants.

Revised UNAIDS/WHO Ethical Guidance for HIV Prevention Trials

JAMA
May 4, 2021, Vol 325, No. 17, Pages 1703-1804
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
Revised UNAIDS/WHO Ethical Guidance for HIV Prevention Trials
Rieke van der Graaf, PhD; Andreas Reis, MD, MSc; Peter Godfrey-Faussett, MBBS
free access
JAMA. 2021;325(17):1719-1720. doi:10.1001/jama.2021.0258
This Viewpoint summarizes updates to the UNAIDS/WHO document on ethical guidance for HIV prevention trials, emphasizing the importance of collaboration among trialists, sponsors, participants, and community members if the world is to reach a target of fewer than 200 000 new infections per year by 2030.

Experts Discuss COVID-19—Variants and Vaccine Efficacy, Immunosuppressed Patients, and More

JAMA
May 4, 2021, Vol 325, No. 17, Pages 1703-1804
https://jamanetwork.com/journals/jama/currentissue

 

JAMA Live Highlights
Experts Discuss COVID-19—Variants and Vaccine Efficacy, Immunosuppressed Patients, and More
free access has active quiz has audio
JAMA. 2021;325(17):1711-1712. doi:10.1001/jama.2021.5938
JAMA Live Highlights features comments from livestream interviews with experts in clinical care, public health, and health policy on critical issues related to the COVID-19 pandemic. Comments have been edited for clarity.

Novel Variant Findings and Challenges Associated With the Clinical Integration of Genomic TestingAn Interim Report of the Genomic Medicine for Ill Neonates and Infants (GEMINI) Study

JAMA Pediatrics
May 2021, Vol 175, No. 5, Pages 449-544
https://jamanetwork.com/journals/jamapediatrics/currentissue

 

Original Investigation
Novel Variant Findings and Challenges Associated With the Clinical Integration of Genomic TestingAn Interim Report of the Genomic Medicine for Ill Neonates and Infants (GEMINI) Study
Jill L. Maron, MD, MPH; Stephen F. Kingsmore, MD; Kristen Wigby, MD; et al.
online only
JAMA Pediatr. 2021;175(5):e205906. doi:10.1001/jamapediatrics.2020.5906
This comparative effectiveness study reports interim variants and associated interpretations of an ongoing study comparing rapid whole-genomic sequencing with a novel targeted genomic platform.

India’s COVID-19 emergency

The Lancet
May 08, 2021 Volume 397 Number 10286 p1683-1780
https://www.thelancet.com/journals/lancet/issue/current

 

Editorial
India’s COVID-19 emergency
India must now pursue a two-pronged strategy. First, the botched vaccination campaign must be rationalised and implemented with all due speed. There are two immediate bottlenecks to overcome: increasing vaccine supply (some of which should come from abroad) and setting up a distribution campaign that can cover not just urban but also rural and poorer citizens, who constitute more than 65% of the population (over 800 million people) but face a desperate scarcity of public health and primary care facilities. The government must work with local and primary health-care centres that know their communities and create an equitable distribution system for the vaccine.
Second, India must reduce SARS-CoV-2 transmission as much as possible while the vaccine is rolled out. As cases continue to mount, the government must publish accurate data in a timely manner, and forthrightly explain to the public what is happening and what is needed to bend the epidemic curve, including the possibility of a new federal lockdown. Genome sequencing needs to be expanded to better track, understand, and control emerging and more transmissible SARS-CoV-2 variants. Local governments have begun taking disease-containment measures, but the federal government has an essential role in explaining to the public the necessity of masking, social distancing, halting mass gatherings, voluntary quarantine, and testing. Modi’s actions in attempting to stifle criticism and open discussion during the crisis are inexcusable.
The Institute for Health Metrics and Evaluation estimates that India will see a staggering 1 million deaths from COVID-19 by Aug 1. If that outcome were to happen, Modi’s Government would be responsible for presiding over a self-inflicted national catastrophe. India squandered its early successes in controlling COVID-19. Until April, the government’s COVID-19 taskforce had not met in months. The consequences of that decision are clear before us, and India must now restructure its response while the crisis rages. The success of that effort will depend on the government owning up to its mistakes, providing responsible leadership and transparency, and implementing a public health response that has science at its heart.

COVID-19 vaccine coverage in health-care workers in England and effectiveness of BNT162b2 mRNA vaccine against infection (SIREN): a prospective, multicentre, cohort study

The Lancet
May 08, 2021 Volume 397 Number 10286 p1683-1780
https://www.thelancet.com/journals/lancet/issue/current

 

Articles
COVID-19 vaccine coverage in health-care workers in England and effectiveness of BNT162b2 mRNA vaccine against infection (SIREN): a prospective, multicentre, cohort study
Victoria Jane Hall, et al and the SIREN Study Group