Monthly Archives: April 2021

Community perception and determinants of willingness to uptake COVID-19 vaccines among residents of Osun State, South-West Nigeria

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International Journal of Community Medicine and Public Health
Vol 8, No 4 (2021) April 2021
https://www.ijcmph.com/index.php/ijcmph/issue/view/75

 

Original Research Articles
Community perception and determinants of willingness to uptake COVID-19 vaccines among residents of Osun State, South-West Nigeria
Patrick A. Akinyemi, Olusola Fajobi, Israel A. Owoade, Olanrewaju T. Elugbaju, Funmilola O. Wuraola

Emergence of a Novel SARS-CoV-2 Variant in Southern California

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JAMA
April 6, 2021, Vol 325, No. 13, Pages 1239-1356
https://jamanetwork.com/journals/jama/currentissue

 

Research Letter
Emergence of a Novel SARS-CoV-2 Variant in Southern California
Wenjuan Zhang, PhD; Brian D. Davis, BSc; Stephanie S. Chen, BSc; et al.
free access has active quiz has multimedia has audio
JAMA. 2021;325(13):1324-1326. doi:10.1001/jama.2021.1612
This research describes findings of sequencing and phylogenetic analyses of SARS-CoV-2 isolates from symptomatic patients cared for at Cedar-Sinai Medical Center in November-December 2020 during a regional surge in cases and hospitalizations.

The Potential Future of the COVID-19 PandemicWill SARS-CoV-2 Become a Recurrent Seasonal Infection?

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JAMA
April 6, 2021, Vol 325, No. 13, Pages 1239-1356
https://jamanetwork.com/journals/jama/currentissue

 

COVID-19: Beyond Tomorrow
The Potential Future of the COVID-19 PandemicWill SARS-CoV-2 Become a Recurrent Seasonal Infection?
Christopher J. L. Murray, MD; Peter Piot, MD
has audio
JAMA. 2021;325(13):1249-1250. doi:10.1001/jama.2021.2828
This Viewpoint discusses the prospect that COVID-19 could become a recurrent seasonal disease like influenza and proposes strategies to mitigate the consequences for communities and health systems, including changes in surveillance, medical and public health response, and socioeconomic programs.

Approaches for Optimal Use of Different COVID-19 VaccinesIssues of Viral Variants and Vaccine Efficacy

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JAMA
April 6, 2021, Vol 325, No. 13, Pages 1239-1356
https://jamanetwork.com/journals/jama/currentissue

 

Approaches for Optimal Use of Different COVID-19 VaccinesIssues of Viral Variants and Vaccine Efficacy
John P. Moore, PhD
has active quiz has multimedia has audio
JAMA. 2021;325(13):1251-1252. doi:10.1001/jama.2021.3465
This Viewpoint proposes ways to maximize vaccine efficacy and allocation given the rise of coronavirus variants and authorization of a Johnson & Johnson vaccine, including reserving the latter for younger healthier populations, boosting it with a single-dose messenger RNA (mRNA) vaccination, and single mRNA immunization of people with prior documented SARS-CoV-2 infection.

SARS-CoV-2 Vaccines

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JAMA
April 6, 2021, Vol 325, No. 13, Pages 1239-1356
https://jamanetwork.com/journals/jama/currentissue

 

JAMA Insights
SARS-CoV-2 Vaccines
C. Buddy Creech, MD, MPH; Shannon C. Walker, MD; Robert J. Samuels, MBChB
free access has active quiz has audio
JAMA. 2021;325(13):1318-1320. doi:10.1001/jama.2021.3199
This JAMA Insights clinical review explains different approaches to SARS-CoV-2 vaccine development, including inactivated and protein subunit, viral vector, and mRNA immunization strategies, and summarizes safety and efficacy data for global products authorized for use or in later-stage clinical trials.

The Complicated Legacy of Cassandra Callender Ethics, Decision-making, and the Role of Adolescents

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JAMA Pediatrics
April 2021, Vol 175, No. 4, Pages 339-440
https://jamanetwork.com/journals/jamapediatrics/currentissue

 

Viewpoint
The Complicated Legacy of Cassandra CallenderEthics, Decision-making, and the Role of Adolescents
Jonathan M. Marron, MD, MPH; Elaine C. Meyer, PhD, RN, MBE; Kerri O. Kennedy, MA, BSN, RN
JAMA Pediatr. 2021;175(4):343-344. doi:10.1001/jamapediatrics.2020.4812
This Viewpoint discusses the role of adolescents in decisions about their health care, particularly potentially life-saving interventions.

A Survey of Camp Leadership to Assess Immunization Requirements, Policies, and Practices in a National Cohort of Summer Camps

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JAMA Pediatrics
April 2021, Vol 175, No. 4, Pages 339-440
https://jamanetwork.com/journals/jamapediatrics/currentissue

 

Research Letter
A Survey of Camp Leadership to Assess Immunization Requirements, Policies, and Practices in a National Cohort of Summer Camps
Carissa Bunke, MD; Natalie Schellpfeffer, MD; Barry Garst, PhD; et al.
JAMA Pediatr. 2021;175(4):421-423. doi:10.1001/jamapediatrics.2020.5342
This study surveys a national cohort of summer camp leadership to assess camps’ immunization requirements, policies, and practices.

Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial

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The Lancet
Apr 10, 2021 Volume 397 Number 10282 p1325-1418
https://www.thelancet.com/journals/lancet/issue/current

 

Articles
Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial
Katherine R W Emary, et al on behalf of the COVID-19 Genomics UK consortium, the AMPHEUS Project,
and the Oxford COVID-19 Vaccine Trial Group
Open Access

Revisiting maternal and child undernutrition in low-income and middle-income countries: variable progress towards an unfinished agenda

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The Lancet
Apr 10, 2021 Volume 397 Number 10282 p1325-1418
https://www.thelancet.com/journals/lancet/issue/current

 

Series
Maternal and Child Undernutrition Progress
Revisiting maternal and child undernutrition in low-income and middle-income countries: variable progress towards an unfinished agenda
Cesar G Victora, Parul Christian, Luis Paulo Vidaletti, Giovanna Gatica-Domínguez, Purnima Menon, Robert E Black

Mobilising evidence, data, and resources to achieve global maternal and child undernutrition targets and the Sustainable Development Goals: an agenda for action

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The Lancet
Apr 10, 2021 Volume 397 Number 10282 p1325-1418
https://www.thelancet.com/journals/lancet/issue/current

 

Maternal and Child Undernutrition Progress
Mobilising evidence, data, and resources to achieve global maternal and child undernutrition targets and the Sustainable Development Goals: an agenda for action
Rebecca A Heidkamp, et al

The NIH Somatic Cell Genome Editing program

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Nature
Volume 592 Issue 7853, 8 April 2021
https://www.nature.com/nature/volumes/592/issues/7853

 

Perspective | 07 April 2021 | Open Access
The NIH Somatic Cell Genome Editing program
This Perspective discusses how the Somatic Cell Genome Editing Consortium aims to accelerate the implementation of safe and effective genome-editing therapies in the clinic.
Krishanu Saha, Erik J. Sontheimer & Jiangbing Zhou
Abstract
The move from reading to writing the human genome offers new opportunities to improve human health. The United States National Institutes of Health (NIH) Somatic Cell Genome Editing (SCGE) Consortium aims to accelerate the development of safer and more-effective methods to edit the genomes of disease-relevant somatic cells in patients, even in tissues that are difficult to reach. Here we discuss the consortium’s plans to develop and benchmark approaches to induce and measure genome modifications, and to define downstream functional consequences of genome editing within human cells. Central to this effort is a rigorous and innovative approach that requires validation of the technology through third-party testing in small and large animals. New genome editors, delivery technologies and methods for tracking edited cells in vivo, as well as newly developed animal models and human biological systems, will be assembled—along with validated datasets—into an SCGE Toolkit, which will be disseminated widely to the biomedical research community. We visualize this toolkit—and the knowledge generated by its applications—as a means to accelerate the clinical development of new therapies for a wide range of conditions.

BNT162b vaccines protect rhesus macaques from SARS-CoV-2

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Nature
Volume 592 Issue 7853, 8 April 2021
https://www.nature.com/nature/volumes/592/issues/7853

 

Article | 01 February 2021
BNT162b vaccines protect rhesus macaques from SARS-CoV-2
BNT162b1 and BNT162b2 are two candidate mRNA vaccines against COVID-19 that elicit high virus-entry inhibition titres in mice, elicit high virus-neutralizing titres in rhesus macaques and protect macaques from SARS-CoV-2 challenge.
Annette B. Vogel, Isis Kanevsky & Ugur Sahin

Advancing development of medicines by academia and non-profit research organizations in the European Union

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Nature Reviews Drug Discovery
Volume 20 Issue 4, April 2021
https://www.nature.com/nrd/volumes/20/issues/4

 

Comment | 23 November 2020
Advancing development of medicines by academia and non-profit research organizations in the European Union
Providing support for medicine development by academics and clinical researchers is a priority for the European Medicines Agency. The recent launch of free scientific advice to academia and non-profit research organizations developing orphan medicines can help align research with regulatory requirements early during medicine development and enhance the chances of success.
Rosa Gonzalez-Quevedo, Constantinos Ziogas  & Anthony Humphreys

From Vaccine Nationalism to Vaccine Equity — Finding a Path Forward

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New England Journal of Medicine
April 8, 2021 Vol. 384 No. 14
http://www.nejm.org/toc/nejm/medical-journal

 

Perspective
From Vaccine Nationalism to Vaccine Equity — Finding a Path Forward
I.T. Katz, R. Weintraub, L.-G. Bekker, and A.M. Brandt
The global effort to develop safe and effective Covid-19 vaccines has yielded remarkable results, owing in part to early, decisive investments in clinical discovery through efforts such as Operation Warp Speed. These achievements highlight the payoff of stable, long-term support of basic research and immunology: our scientific community was prepared to act. Now, as the global community faces scarce supply, we confront a distressing reality: our current global vaccination rates of roughly 6.7 million doses per day translate to achieving herd immunity (70 to 85% of the population having received a two-dose vaccine) in approximately 4.6 years. Vaccine distribution remains nonexistent in many of the poorest countries, and experts anticipate that 80% of the population in low-resource settings will not receive a vaccine this year. Although investment in discovery is critical, the long-term neglect of public health and global delivery strategies has left us poorly equipped to end this pandemic.

The complex bottlenecks in allocating and disseminating newly approved vaccines require urgent attention. They include ensuring production capacity, supply chains, human resources, and health infrastructures to deliver vaccines safely, effectively, and quickly. Barriers to vaccine uptake are augmented by mistrust, misinformation, and historical legacies affecting vaccine confidence.1 Even wealthy countries have faced formidable obstacles and made critical missteps in implementing mass-vaccination programs.

Furthermore, the early competitive procurement of vaccines by the United States and purchases by other high-resource countries have fed a widespread assumption that each country will be solely responsible for its own population. Such vaccine nationalism perpetuates the long history of powerful countries securing vaccines and therapeutics at the expense of less-wealthy countries; it is short-sighted, ineffective, and deadly. Ultimately, wealthy countries have a critical interest in assisting global vaccination, especially in countries that will need supportive partnerships to ensure supply and delivery. Moreover, an uncoordinated patchwork of immunity could exacerbate the rise of escape variants that could alter vaccines’ effectiveness.

These inequalities reveal a fundamentally flawed view of global health, and our global economy more broadly, in which vaccines and essential medications are treated as a market commodity rather than as a public good. We have seen similar policies enacted during past pandemics. During the height of the HIV epidemic, for example, most low-resource countries could not access lifesaving antiretroviral therapy because of the prohibitively high prices set by the pharmaceutical industry and the belief within United Nations agencies and among major donors that the focus in these settings should be on prevention instead of treatment. The commodification of global public goods reinforces widespread inequities in access and exacerbates vast disparities in health and economic well-being. Ultimately, addressing critical constraints is both a moral issue and one of national security that requires bold, decisive action to ensure expansion of supply, distribution, and delivery of Covid-19 vaccines.

The United States, under the Biden administration, and the G7 nations have committed support for global vaccine procurement through the Covid-19 Vaccines Global Access (COVAX) program, which supplies vaccines to low- and middle-income countries, but this funding alone remains inadequate. Currently, COVAX plans to vaccinate at least 20% of the population of participating countries by the end of 2021.2 Though this would be a substantial achievement, it falls far short of the goal of securing global herd immunity in a timely fashion.

The United States has an opportunity to lead by building on past effective efforts and investing in strategies with proven success. The challenges of delivering costly HIV therapeutics to low-resource settings inspired the creation of programs such as the President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria, which have been critical to ensuring global scale-up of antiretroviral therapy for populations that previously lacked access. Reflecting on the impact of PEPFAR, which was approved with bipartisan congressional support in 2003, Anthony Fauci noted on the program’s 15th anniversary that “PEPFAR has done as much as or more than any other program in enhancing the humanitarian image of the United States and has firmly established it as a key player in the response to a historic global health crisis.”3

The United States could build on PEPFAR’s success by committing to what some experts have dubbed a President’s Emergency Plan for Vaccine Access and Relief (PEPVAR).4 Such a program could integrate global health needs into ongoing funding priorities, augment funding for vaccine production and delivery, and assist in building critical health infrastructures, while providing the Biden administration an opportunity to rejoin the global diplomatic community.

PEPVAR could use strategic lessons from the global responses to HIV, H1N1 influenza, and Ebola by engaging with multinational organizations such as the World Health Organization, as well as governments, ministries of health, and affected communities. The program could help accelerate distribution of Covid-19 vaccines, working with national governments and multilateral organizations. Unlike COVAX, whose mission is primarily to increase and improve vaccine delivery to countries that are most in need, PEPVAR could partner with, support, and accelerate existing institutional mechanisms for ensuring vaccine access. Like PEPFAR, it could focus attention on data and analytics, equitable distribution, workforce development, and future pandemic preparedness, while accelerating development of additional necessary vaccines to address potential viral variants.

The success of such programs rests on immediate expansion of the supply of approved Covid-19 vaccines. India, for example, has secured substantially more vaccine than other low- and middle-income countries thanks to a partnership between AstraZeneca and the Serum Institute of India, one of the world’s largest vaccine manufacturers. The agreement allowed AstraZeneca to leverage the Serum Institute’s manufacturing capacity in exchange for vaccine doses for Indian citizens. Other pharmaceutical companies have also entered into agreements to expand global production by means of horizontal cooperation. Novartis, for example, has announced an initial agreement to help manufacture the Pfizer–BioNTech vaccine.

Though pharmaceutical companies have preferred to use voluntary licensing agreements to control who can produce a patented good, pressure has mounted on the World Trade Organization to consider a Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver for Covid-19 vaccines. This proposal, put forward by India and South Africa and supported by more than 90 countries, would temporarily waive pharmaceutical patent protection, and substantially reduce the costs of manufacturing vaccines globally. Opponents of a TRIPS waiver argue that intellectual property protection is key to vaccine discovery and that without it, future innovation will be limited. While recognizing that patents provide essential incentives for companies to invest in drug and vaccine discovery, we believe the context of a pandemic, combined with the $18 billion in public funding that has already supported the development of Covid-19 vaccines, may argue against patent protection at this time.

Even with patent waivers, we may simply lack sufficiently consistent manufacturing capacity globally to develop and produce the current generation of vaccines. Long-term investment strategies are critical if we are to withstand the current pandemic and be prepared for future ones. Beyond expanding short-term supply, fostering global cooperation will better situate the global economy to rapidly supply vaccines and therapeutics in the future. Such cooperation is not only a matter of social justice, it is also a sound pragmatic response to ending a pandemic in which a virus and its variants easily cross borders. With a globally coordinated strategy, epidemiology, efficacy, and ethics can be fully aligned.

Covid-19 vaccines provide a pathway out of this pandemic, but bold, innovative policies that ensure fast and fair distribution are also critical. The United States has an unusual and urgent opportunity to ensure that Covid-19 vaccines are available to all. As Ursula von der Leyen, president of the European Commission, recently explained: “A global pandemic requires a world effort to end it — none of us will be safe until everyone is safe.” The Biden administration is well positioned to take a leadership role in this next critical phase.

Vaccinating the world is not only a moral obligation to protect our neighbors, it also serves our self-interest by protecting our security, health, and economy. These goals will not be accomplished by making the world wait for wealthy countries to be vaccinated first. By investing in multilateral partnerships with a sense of shared commitment and employing a global allocation strategy that increases supply and manufacturing, we can meet the urgent challenge of Covid-19, while creating sustainable infrastructures and health systems for the future. Getting the world vaccinated may well be the critical test of our time.

The impact and cost-effectiveness of introducing the 10-valent pneumococcal conjugate vaccine into the paediatric immunisation programme in Iceland—A population-based time series analysis

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PLoS One
http://www.plosone.org/
[Accessed 10 Apr 2021]

 

The impact and cost-effectiveness of introducing the 10-valent pneumococcal conjugate vaccine into the paediatric immunisation programme in Iceland—A population-based time series analysis
Elias Eythorsson, Tinna L. Ásgeirsdóttir, Helga Erlendsdóttir, Birgir Hrafnkelsson, Karl G. Kristinsson, Ásgeir Haraldsson
Research Article | published 08 Apr 2021 PLOS ONE
https://doi.org/10.1371/journal.pone.0249497

Relationship Between Public Mental Health and Immune Status During the COVID-19 Pandemic: Cross-Sectional Data from Saudi Arabia

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Risk Management and Healthcare Policy
https://www.dovepress.com/risk-management-and-healthcare-policy-archive56
[Accessed 10 Apr 2021]

 

Original Research
Relationship Between Public Mental Health and Immune Status During the COVID-19 Pandemic: Cross-Sectional Data from Saudi Arabia
Alghamdi BS, Alatawi Y, Alshehri FS, Tayeb HO, Tarazi FI
Risk Management and Healthcare Policy 2021, 14:1439-1447

Monitoring COVID-19 Vaccine Acceptance in Kuwait During the Pandemic: Results from a National Serial Study

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Risk Management and Healthcare Policy
https://www.dovepress.com/risk-management-and-healthcare-policy-archive56
[Accessed 10 Apr 2021]

 

Original Research
Monitoring COVID-19 Vaccine Acceptance in Kuwait During the Pandemic: Results from a National Serial Study
AlAwadhi E, Zein D, Mallallah F, Bin Haider N, Hossain A
Risk Management and Healthcare Policy 2021, 14:1413-1429
Published Date: 8 April 2021

The story behind COVID-19 vaccines

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Science
09 April 2021 Vol 372, Issue 6538
http://www.sciencemag.org/current.dtl

 

Editorial
The story behind COVID-19 vaccines
By Anthony S. Fauci
Science 09 Apr 2021 : 109
Amid the staggering amount of suffering and death during this historic pandemic of COVID-19, a remarkable success story stands out. The development of several highly efficacious vaccines against a previously unknown viral pathogen, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in less than 1 year from the identification of the virus is unprecedented in the history of vaccinology. A frequently asked question is how such an extraordinary accomplishment could have been realized in such a short time frame, when timelines for other vaccines are measured in years if not decades. In fact, concern about this truncated timeline has contributed in part to the hesitancy in accepting these vaccines. What is not fully appreciated is that the starting point of the timeline for SARS-CoV-2 vaccines was not 10 January 2020, when the Chinese published the genetic sequence of the virus. Rather, it began decades earlier, out of the spotlight.

Two activities predate the successful COVID-19 vaccines: the utilization of highly adaptable vaccine platforms such as RNA (among others) and the adaptation of structural biology tools to design agents (immunogens) that powerfully stimulate the immune system. The RNA approach evolved over several years owing to the ingenuity of individual scientists, including Drew Weissman and Katalin Karikó, and the concentrated efforts of several biotech and pharmaceutical companies.

The discovery of an immunogen adaptable to the multiple platforms (messenger RNA and others) used for COVID-19 vaccines resulted from collaboration across different scientific subspecialities. At the Vaccine Research Center (VRC) of the U.S. National Institute of Allergy and Infectious Diseases, a group led by Peter Kwong had for several years used tools of structure-based vaccine design to determine the optimal structural conformation of a trimeric protein on the surface of the virus (the envelope protein) that allows HIV to bind to cells and ultimately trigger the production of antibodies that neutralize many HIV viral strains. Although this sophisticated approach has not yet led to a successful HIV vaccine, it caught the attention of another VRC investigator, Barney Graham, who was interested in generating a vaccine for respiratory syncytial virus (RSV). Graham joined Jason McLellan (of Kwong’s team) to adapt a structure-based approach to an RSV vaccine. They identified the prefusion conformation of the viral spike protein as highly immunogenic and created mutations to stabilize that conformation for successful use as an immunogen. This was a huge step toward the creation of a successful RSV vaccine.

VRC researchers and colleagues then built on the RSV advances. Graham’s team, including Kizzmekia Corbett, and collaborators in the laboratories of McLellan and Andrew Ward adopted this approach of mutational stabilization of prefusion proteins in their work on the spike protein of the coronaviruses that cause Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS). So, when the genetic sequence of the SARS-CoV-2 became available, Graham’s team lost no time in joining their long-time collaborators at Moderna to develop an RNA vaccine using a stabilized, prefusion spike protein as the immunogen. Pfizer and BioNTech, where Karikó was working, also used the RNA platform that she and Weissman had perfected and the immunogen designed by Graham to develop an RNA vaccine. Additional companies also used Graham’s immunogen in other vaccine platforms that had been evolving for years, to make SARS-CoV-2 vaccines.

SARS-CoV-2 vaccines based on the new immunogen rapidly moved to clinical trials. Several of these vaccines were tested in phase 3 efficacy trials at a time when the level of community spread of SARS-CoV-2 was extremely high, allowing vaccine efficacy endpoints of greater than 90% to be reached in a timely fashion. The speed and efficiency with which these highly efficacious vaccines were developed and their potential for saving millions of lives are due to an extraordinary multidisciplinary effort involving basic, preclinical, and clinical science that had been under way—out of the spotlight—for decades before the unfolding of the COVID-19 pandemic. When the stories and recounting of this pandemic are written, it is important that this history not be forgotten, as we are reminded once again of the societal value of a sustained and robust support of our scientific enterprise.

The incubation period during the pandemic of COVID-19: a systematic review and meta-analysis

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Systematic Reviews
https://systematicreviewsjournal.biomedcentral.com/articles
[Accessed 10 Apr 2021]

 

Systematic review update
The incubation period during the pandemic of COVID-19: a systematic review and meta-analysis
The aim of our study was to determine through a systematic review and meta-analysis the incubation period of COVID-19. It was conducted based on the preferred reporting items for systematic reviews and meta-an…
Authors: Wafa Dhouib, Jihen Maatoug, Imen Ayouni, Nawel Zammit, Rim Ghammem, Sihem Ben Fredj and Hassen Ghannem
Citation: Systematic Reviews 2021 10:101
Published on: 8 April 2021

The informed consent process in health research with under-served populations: a realist review protocol

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Systematic Reviews
https://systematicreviewsjournal.biomedcentral.com/articles
[Accessed 10 Apr 2021]

 

https://stm.sciencemag.org/
Protocol
The informed consent process in health research with under-served populations: a realist review protocol
The informed consent process aims to provide potential participants with information about health research that enables them to make an informed decision as to whether they choose to participate, or not. Howev…
Authors: Eleanor Hoverd, Sophie Staniszewska and Jeremy Dale
Citation: Systematic Reviews 2021 10:103
Published on: 9 April 2021

Meningococcal carriage among Hajj pilgrims, risk factors for carriage and records of vaccination: a study of pilgrims to Mecca

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Tropical Medicine & International Health
Volume 26, Issue 4 Pages: i-iv, 385-502 April 2021
https://onlinelibrary.wiley.com/toc/13653156/current

 

Original Research Papers
Meningococcal carriage among Hajj pilgrims, risk factors for carriage and records of vaccination: a study of pilgrims to Mecca
Abrar Alasmari et al
Pages: 453-461
First Published: 08 January 2021

Workplace influenza vaccination to reduce employee absenteeism: An economic analysis from the employers’ perspective

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Vaccine
Volume 39, Issue 14 Pages 1877-2016 (1 April 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/14

 

Research article Abstract only
Workplace influenza vaccination to reduce employee absenteeism: An economic analysis from the employers’ perspective
Frederik Verelst, Philippe Beutels, Niel Hens, Lander Willem

Impact of Media Coverage on Influenza Vaccine Coverage in Elderly Individuals from 2020 to 2021 in the Republic of Korea

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Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 10 Apr 2021)

 

Open Access Communication
Impact of Media Coverage on Influenza Vaccine Coverage in Elderly Individuals from 2020 to 2021 in the Republic of Korea
by Yunhyung Kwon et al
Vaccines 2021, 9(4), 367; https://doi.org/10.3390/vaccines9040367 (registering DOI) – 10 Apr 2021
Abstract
Increased awareness of adverse events following immunization (AEFI) can disrupt vaccination programs. In South Korea, a report of alleged influenza vaccine-related deaths attracted significant media attention in 2020. We retrieved the vaccination coverage and AEFI data to determine their association with media coverage. […

Correcting HPV Vaccination Misinformation Online: Evaluating the HPV Vaccination NOW Social Media Campaign

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Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 10 Apr 2021)

 

Open Access Article
Correcting HPV Vaccination Misinformation Online: Evaluating the HPV Vaccination NOW Social Media Campaign
by Beth Sundstrom et al
Vaccines 2021, 9(4), 352; https://doi.org/10.3390/vaccines9040352 – 06 Apr 2021
Abstract
The human papillomavirus (HPV) vaccine provides protection from six HPV-related cancers. Approximately half of South Carolina adolescents have not completed the vaccination series, representing a missed opportunity to prevent cancer. The HPV Vaccination NOW: This is Our Moment social media campaign is an [...]

What Is the State-of-the-Art in Clinical Trials on Vaccine Hesitancy 2015–2020?

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Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 10 Apr 2021)

 

Open Access Review
What Is the State-of-the-Art in Clinical Trials on Vaccine Hesitancy 2015–2020?
by Carla Pires
Vaccines 2021, 9(4), 348; https://doi.org/10.3390/vaccines9040348 – 05 Apr 2021
Abstract
Background: Vaccine hesitancy is related to a delay in acceptance or refusal of vaccination. Aim: to perform a systematic review of clinical trials on vaccine hesitancy (2015–2020). Methods: a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria (PRISMA). […]

Critical Appraisal of Systematic Reviews With Costs and Cost-Effectiveness Outcomes: An ISPOR Good Practices Task Force Report

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Value in Health
April 2021 Volume 24 Issue 4 p463-604
https://www.valueinhealthjournal.com/current

 

ISPOR REPORT
Critical Appraisal of Systematic Reviews With Costs and Cost-Effectiveness Outcomes: An ISPOR Good Practices Task Force Report
Olena (Lena) Mandrik, J.L. (Hans) Severens, Ariel Bardach,…Luke Vale, Torbjørn Wisløff, Jeremy D. Goldhaber-Fiebert
Published in issue: April 2021

Engaging the Voices of Children: A Scoping Review of How Children and Adolescents Are Involved in the Development of Quality-of-Life–Related Measures

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Value in Health
April 2021 Volume 24 Issue 4 p463-604
https://www.valueinhealthjournal.com/current

 

PATIENT-REPORTED OUTCOMES
Engaging the Voices of Children: A Scoping Review of How Children and Adolescents Are Involved in the Development of Quality-of-Life–Related Measures
Jessica Willis, Dena Zeratkaar, Julia ten Hove, Peter Rosenbaum, Gabriel M. Ronen
Published online: December 28, 2020
Highlights
:: Children and adolescents should participate in content development of patient-reported outcomes about themselves.
:: Focus groups and interviews are the most frequently used qualitative methods to elicit the content of interest.
:: Play activities help children communicate their experiences and feelings.
:: There is limited consistency in how researchers undertake and report their methodologies.
:: This review highlights the value of dedicated qualitative papers to report development of patient-reported outcomes.
Conclusions
Researchers frequently involve children and adolescents in qualitative methods when developing QoL-related measures; however, there is little information about the methods used. Better reporting of methodology, improved dissemination of methods guidelines, and research into optimal ways of including children and adolescents in the process of instrument development would be useful.

Media/Policy Watch

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Media/Policy Watch
This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.
We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.
The sheer volume of vaccine and pandemic-related coverage is extraordinary. We will strive to present the most substantive analysis and commentary we encounter.

 

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 10 Apr 2021
Ideas
What America’s Vaccination Campaign Proves to the World
The U.S. stumbled early in the pandemic, but the vaccine rollout could reboot the country’s image.
Apr 10. 2021
Anne Applebaum, Staff writer at The Atlantic

Politics
Vaccine Refusal Will Come at a Cost—For All of Us
People who refuse to get the COVID-19 vaccine will have higher health-care costs. The rest of us will foot the bill.
Edward-Isaac Dovere
Apr 10. 2021

Health
A Better Solution Than Laminating Your Vaccine Card
Political grandstanding about vaccine passports serves no one.
James Hamblin
April 9, 2021

 

BBC
http://www.bbc.co.uk/
Accessed 10 Apr 2021
[No new, unique, relevant content]

 

The Economist
http://www.economist.com/
Accessed 10 Apr 2021
The Americas
Cuba may become the smallest country to make covid-19 vaccines …
Whether they will be approved elsewhere remains to be seen
Apr 10th 2021 edition

 

Financial Times
https://www.ft.com/
Accessed 10 Apr 2021
Coronavirus: Georgia pauses J&J vaccine at one site following adverse reactions — as it happened
India rejects vaccine shortage claims
April 9, 2021

 

Forbes
http://www.forbes.com/
Accessed 10 Apr 2021
[No new, unique, relevant content]

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 10 Apr 2021
Snapshot April 5, 2021
The New Age of Protectionism
Wealthy democratic governments have pushed liberal market principles aside in the face of vaccine shortages.
Henry Farrell and Abraham Newman

 

Foreign Policy
http://foreignpolicy.com/
Accessed 10 Apr 2021
China Brief
China’s Vaccine Diplomacy Has Mixed Results
Concerns about the efficacy of Sinovac and Sinopharm has dented their reputation, even among allies of Beijing.
By James Palmer
| April 7, 2021, 5:59 PM

 

New Yorker
http://www.newyorker.com/
Accessed 10 Apr 2021
[No new, unique, relevant content]

 

New York Times
http://www.nytimes.com/
Accessed 10 Apr 2021
U.S.
Incarcerated and Infected: How the Virus Tore Through the U.S. Prison System
Since March 2020, New York Times reporters have tracked every known coronavirus case in every correctional setting in the nation. More than 2,700 inmates have died.
By Eddie Burkhalter, Izzy Colón, Brendon Derr, Lazaro Gamio, Rebecca Griesbach, Ann Hinga Klein, Danya Issawi, K.b. Mensah, Derek M. Norman, Savannah Redl, Chloe Reynolds, Emily Schwing, Libby Seline, Rachel Sherman, Maura Turcotte and Timothy Williams
April 10

Asia Pacific
Complacency and Missteps Deepen a Covid-19 Crisis in India
The new wave will hurt global efforts and vaccine supplies, experts say. Researchers are scrambling to assess whether new coronavirus variants are playing a role in India.
By Mujib Mashal and Hari Kumar
April 9

Economy
I.M.F. Seminar Stresses Importance of Global Vaccinations
Jerome H. Powell, the Federal Reserve chair, and the managing director of the International Monetary Fund, Kristalina Georgieva, emphasized the economic need for worldwide vaccinations on Thursday.
By Reuters
April 9

 

Washington Post
https://www.washingtonpost.com/
Accessed 10 Apr 2021
J&J vaccine problems hamper US military vaccines overseas
WASHINGTON — U.S. military leaders said Thursday that recent problems with the Johnson & Johnson vaccine have made it more difficult to provide shots for forces overseas, and that vaccines have been offered to service members’ families or other tier two beneficiaries in only 40% of the military sites outside the U.S.
Apr 8, 2021

Think Tanks et al

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Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 10 Apr 2021
[No new digest content identified]
 
 
Center for Global Development [to 10 Apr 2021]
http://www.cgdev.org/page/press-center
Publication
One Year Later: How Africa is Tackling the Pandemic and Preparing for a Post-COVID World
Event
4/7/21
While the COVID-19 pandemic has setback development outcomes across the globe, Africa has felt the economic effects of the pandemic strongly. COVID-19 pushed about 30 million Africans into extreme poverty, with vulnerable groups disproportionately impacted, and the continent experienced its first recession in half a century. Fiscal deficits have reached historic highs, and the debt-to-GDP ratio Africa is expected to increase significantly to over 70 percent in 2021 from 60 percent in 2019, raising concerns of debt sustainability. At the same time, outcomes in education, routine vaccination, and equality have suffered.

April 5, 2021
A New IMF Pandemic Window Could Provide $30 Billion to Finance Vaccines for Developing Countries
While those lucky enough to live in the United States or Europe fret about the extra weeks before their vaccine jab is scheduled, 6 billion people in developing countries will need to wait months, if not years. COVID-19 vaccine production lags far behind demand, and one reason why developing countries find themselves at the back of the queue is that they were unable collectively to make the firm financial offers for advance purchases when these vaccines were still in the making.
Masood Ahmed, John Hicklin and Hannah Brown

4/5/21
Vaccine Financing: How a Redesigned IMF Instrument Can Provide a Shot in the Arm for the Global Pandemic Response
Publication
A new IMF rapid credit window could provide some $30 billion to cover the vaccine financing needs for most developing countries through 2021-22. The mechanism would facilitate collective action to negotiate increased production, the main obstacle to achieving vaccine coverage and rectifying the gross inequities in current distribution. It would remain in place for future global pandemic responses.

April 5, 2021
COVID-19 Vaccine Certificate: Will the US Catch Up with the Rest of the World?
As economies start opening up, the COVID Vaccine Certificate is increasingly becoming a ticket to return to normality, lifting restrictions on work, travel and leisure. Because of the formidable constraints, any US path to a CVC should start with a light touch.
Alan Gelb and Anit Mukherjee
 
 
Chatham House [to 10 Apr 2021]
https://www.chathamhouse.org/
Accessed 10 Apr 2021
[No new digest content identified]

 
 

CSIS
https://www.csis.org/
Accessed 10 Apr 2021
On-Demand Event
Trusting a Covid-19 Vaccine: What’s Next?
April 9, 2021

 
 
Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 10 Apr 2021
April 9, 2021 News Release
Vaccine Monitor: More than Half of Rural Residents Have Gotten a COVID-19 Vaccine or Intend to Do So as Soon as Possible
More than half (54%) of rural adults say they have already gotten at least one dose of a COVID-19 vaccine or will do so as soon as possible, as rural residents report less issues with both supply and access than those living in urban and suburban areas, according to a…

April 7, 2021 News Release
Understanding COVID-19 Vaccine Mandates
As the vaccine rollout continues across the country, a key question is whether and how far governments and employers can go to require the public and workers to get vaccinated. Our new issue brief explains the legal basis for vaccine mandates and what limitations might apply.

April 6, 2021 News Release
KFF/Post Survey Reveals the Serious Mental Health Challenges Facing Frontline Health Care Workers a Year into the COVID-19 Pandemic
About 1 in 6 Tested Positive for COVID-19, though Few Experienced Major Symptoms; Those Working in Nursing Homes or Assisted Living Facilities Most Likely to Report Testing Positive More than a year into the COVID-19 pandemic, a majority of frontline health care workers say the crisis is taking a toll…
 
 
World Economic Forum [to 10 Apr 2021]
https://agenda.weforum.org/news/
Media
Accessed 10 Apr 2021
[No new digest content identified]

Vaccines and Global Health: The Week in Review :: 3 April 2021

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

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

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

vaccines-and-global-health_the-week-in-review_3-apr-2021Download

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

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

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

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

Highlights from the Meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization – 22-24 March 2021

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Milestones :: Perspectives :: Research

 

Highlights from the Meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization – 22-24 March 2021
(Full report will be published in the Weekly Epidemiological Record on 4 June 2021, and only the wording of the full report should be considered as final.)
Ebola Vaccines
:: Two Ebola vaccines have been licensed. One has been WHO prequalified (rVSVΔG-ZEBOV-GPvaccine) and the other is under review(Ad26.ZEBOV and MVA-BN-Filo Ebola vaccines administered as a heterologous prime boost 8 weeks apart).
:: In the context of an Ebola Vaccine Disease (EVD) outbreak response, SAGE made a recommendation for off-label use of the two Ebola vaccines to include infants and children from birth to 17 years of age, as well as pregnant and lactating women.
:: SAGE reconfirmed its previous recommendation to use a ring vaccination strategy for EVD outbreak response.
:: Given current vaccine supply constraints and the unknown duration of protection, wide-spread preventive use of Ebola vaccines in the absence of an outbreak is currently not recommended.
:: SAGE requested the development of a learning agenda to more broadly examine the potential preventive role of Ebola vaccines and to provide more clarity on vaccine use and vaccine demand in the longer term.
:: SAGE urged manufacturers to increase production capacity to meet the expected vaccine demand resulting from the recommendations.

 

Polio
:: SAGE was pleased to note a significant drop in wild poliovirus detections in the endemic areas during the past 6 months. However, SAGE expressed concern about the inability of the program to effectively control outbreaks of circulating vaccine-derived poliovirus type 2 (cVDPV2) in Africa and Asia. SAGE noted that the first cVDPV2 outbreak response campaign with novel oral polio vaccine type 2 (nOPV2) was conducted in Nigeria in March 2021.
:: SAGE recommended that WHO prequalified Sabin-based IPV may be used interchangeably with the traditional Salk-based IPV.•SAGE agreed with the Global Polio Eradication Initiative plan for transition from initial to wider nOPV2 use for response to cVDPV2 outbreaks, contingent on safety and genetic stability reviews.
:: SAGE recommended that vigorous efforts be made to improve inactivated polio vaccine (IPV) coverage in locations at risk of cVDPV2 outbreaks to reduce the number of susceptible children before transmission or outbreaks can occur.
:: SAGE urged all countries at risk of cVDPV2 outbreaks to prepare to meet the criteria for use of nOPV2 and to complete a readiness assessment.
:: SAGE emphasized that the priority for countries experiencing cVDPV2 outbreaks is to conduct high quality outbreak responses without delay, with whichever oral polio vaccine is available to them.

 

COVID-19 Vaccines
Review of interim data on Sinopharm and Sinovac COVID-19 vaccine products
:: Interim analyses of clinical trial data for two inactivated COVID-19 vaccines, one from Sinovac and one from Sinopharm, were presented to SAGE. Both vaccines are already in use in many countries, but neither product has received authorization by a stringent regulatory authority. Both companies have submitted dossiers for their products to WHO for emergency use listing. SAGE will consider policy recommendations for each vaccine once emergency use listing by WHO is obtained. Vaccines demonstrated safety and good efficacy against symptomatic COVID-19 disease but both vaccines lacked data in older age groups and in persons with comorbidities. Post-introduction vaccine effectiveness and safety studies will be needed to address the impact on those sub-populations.

 

Review of case definitions and clinical endpoints used in trials for COVID-19 vaccines
:: SAGE noted that COVID-19 vaccine efficacy results from different trials cannot be directly compared against each other. They must be interpreted in the context of study designs(including case definitions, clinical endpoints, access to testing), target populations, and COVID-19 epidemiologic conditions (including circulation of variants of concern).
:: SAGE therefore requested thatCOVID-19 vaccine communications avoid direct comparisons of vaccine efficacies between COVID-19 vaccine products and instead discuss vaccines in their totality, taking into consideration their characteristics with regards to vaccine logistics, programmatic ease and safety in addition to vaccine efficacy.

 

COVID-19 Variants
:: SAGE requested that data on performance against variants of concern (VOCs)be gathered for all COVID-19 vaccines.
:: Methods and approaches to collect data on vaccine performance against VOCs should be harmonized and laboratory, clinical and observational data should be triangulated.
:: If VOCs significantly change the performance of vaccines, implications for vaccination strategies will need to be considered.

 

COVID-19 Vaccination and Early Learning
:: SAGE noted that it was valuable for countries to share lessons learned from COVID-19 vaccine rollout in order to benefit from each other’s experiences.
:: Introduction of COVID-19 vaccination and reaching adults for vaccination is complex. This effort benefits from strong political will; comprehensive communication and community engagement; robust microplanning; interoperable digital tools which allow registration, safety monitoring, vaccine stock management, follow-up reminders, and vaccination certificates; and which engages partners and stakeholders, including the private sector.
:: Introduction of COVID-19 vaccination should be taken as an opportunity for strengthening broader immunization and health systems to resolve existing weaknesses and to meet future needs for robust essential health services.

 

COVID-19 Vaccine safety
:: To date, post-introduction safety data from COVID-19 vaccines give assurance that safety surveillance is performing well and that rare adverse events are being captured. The response to the global pandemic has contributed to the strengthening of safety monitoring systems at global, regional and national levels.
:: Safety signals for the four COVID-19 vaccines with WHO interim recommendations for use that were analysed by the Global Advisory Committee for Vaccine SafetyCOVID-19 subcommittee show that the overall benefits in preventing severe disease and deaths from SARS-COV-2 infection remain favourable and outweigh any identified risks with these vaccines.
:: Appropriate communication on the benefit-risk profile of COVID-19 vaccines remains crucial to maintain confidence in immunization programmes and to avoid vaccine hesitancy. Furthermore, there is a need to carefully consider the negative consequences of rigorously applying precautionary principles to suspend vaccinations while a safety signal is still being investigated.

 

Measles Rubella
:: SAGE recognized that measles control and elimination efforts need significant improvement. Current measles and rubella policies are appropriate, but there are major issues related to policy implementation and sub-national heterogeneity. Given the ongoing and increasing risk of measles outbreaks, SAGE supported urgent implementation of the Measles Outbreaks Strategic Response Plan. :: SAGE strongly advised WHO and partners to maintain resources for measles and rubella efforts and to restore those that have been redeployed to the COVID-19 response, given the growing immunity gaps and increasing risk of measles outbreaks.
:: SAGE strongly advocated more research and innovation on measles and rubella, including faster progress on subnational data science and the development of measles rubella microarray patch vaccines and Rapid Diagnostic Tests as potential game-changers.
:: SAGE recommends measles rubella andCOVID-19 vaccine co-administration studies be planned and executed to facilitate health worker immunization and eventually measles rubella vaccination catch-up as COVID-19 vaccination roll out extends to younger age groups.

 

Vaccine Acceptance and Uptake
:: SAGE was presented with an update on the field of work in relation to acceptance and uptake of vaccination, and a summary of work currently underway to develop tools and guidance to measure and address behavioural and social drivers of vaccination. Workout puts will include core indicators as well as corresponding interventions most likely to affect attitudes, intentions and uptake.
:: Much has been learned in recent years on how to equitably and sustainably drive vaccine acceptance and uptake for vaccination, particularly with regards to childhood vaccination.
:: The latest evidence and knowledge have enabled development of a framework to illustrate that uptake is affected by what people think and feel, social influences, motivation, and
44practical/logistical factors. This framework enables a holistic determination of the full range of possible drivers to enable comprehensiveness in the measures.
:: The current context (given the challenges and opportunities for both routine immunization and for COVID-19 vaccination) highlights the importance of supporting programmes to gather and use behavioural and social data to determine how different factors contribute to under-vaccination, and to identify evidence-based interventions that are prioritized and adapted locally.

Joint Statement – “International Pandemic Treaty”

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Milestones :: Perspectives :: Research

 

Joint Statement – “International Pandemic Treaty”

COVID-19 shows why united action is needed for more robust international health architecture
30 March 2021
[Editor’s text bolding]
The COVID-19 pandemic is the biggest challenge to the global community since the 1940s. At that time, following the devastation of two world wars, political leaders came together to forge the multilateral system. The aims were clear: to bring countries together, to dispel the temptations of isolationism and nationalism, and to address the challenges that could only be achieved together in the spirit of solidarity and cooperation, namely peace, prosperity, health and security.

Today, we hold the same hope that as we fight to overcome the COVID-19 pandemic together, we can build a more robust international health architecture that will protect future generations. There will be other pandemics and other major health emergencies. No single government or multilateral agency can address this threat alone. The question is not if, but when. Together, we must be better prepared to predict, prevent, detect, assess and effectively respond to pandemics in a highly coordinated fashion. The COVID-19 pandemic has been a stark and painful reminder that nobody is safe until everyone is safe.

We are, therefore, committed to ensuring universal and equitable access to safe, efficacious and affordable vaccines, medicines and diagnostics for this and future pandemics. Immunization is a global public good and we will need to be able to develop, manufacture and deploy vaccines as quickly as possible.

This is why the Access to COVID-19 Tools Accelerator (ACT-A) was set up in order to promote equal access to tests, treatments and vaccines and support health systems across the globe. ACT-A has delivered on many aspects but equitable access is not achieved yet. There is more we can do to promote global access.

 

To that end, we believe that nations should work together towards a new international treaty for pandemic preparedness and response.

Such a renewed collective commitment would be a milestone in stepping up pandemic preparedness at the highest political level. It would be rooted in the constitution of the World Health Organization, drawing in other relevant organizations key to this endeavour, in support of the principle of health for all.  Existing global health instruments, especially the International Health Regulations, would underpin such a treaty, ensuring a firm and tested foundation on which we can build and improve.

The main goal of this treaty would be to foster an all-of-government and all-of-society approach, strengthening national, regional and global capacities and resilience to future pandemics. This includes greatly enhancing international cooperation to improve, for example, alert systems, data-sharing, research, and local, regional and global production and distribution of medical and public health counter measures, such as vaccines, medicines, diagnostics and personal protective equipment.

It would also include recognition of a “One Health” approach that connects the health of humans, animals and our planet. And such a treaty should lead to more mutual accountability and shared responsibility, transparency and cooperation within the international system and with its rules and norms.

To achieve this, we will work with Heads of State and governments globally and all stakeholders, including civil society and the private sector. We are convinced that it is our responsibility, as leaders of nations and international institutions, to ensure that the world learns the lessons of the COVID-19 pandemic.

At a time when COVID-19 has exploited our weaknesses and divisions, we must seize this opportunity and come together as a global community for peaceful cooperation that extends beyond this crisis. Building our capacities and systems to do this will take time and require a sustained political, financial and societal commitment over many years.

Our solidarity in ensuring that the world is better prepared will be our legacy that protects our children and grandchildren and minimizes the impact of future pandemics on our economies and our societies.

 

Pandemic preparedness needs global leadership for a global health system fit for this millennium. To make this commitment a reality, we must be guided by solidarity, fairness, transparency, inclusiveness and equity.

By:
J. V. Bainimarama, Prime Minister of Fiji;
Prayut Chan-o-cha, Prime Minister of Thailand;
António Luís Santos da Costa, Prime Minister of Portugal;
Mario Draghi, Prime Minister of Italy;
Klaus Iohannis, President of Romania;
Boris Johnson, Prime Minister of the United Kingdom;
Paul Kagame, President of Rwanda;
Uhuru Kenyatta, President of Kenya;
Emmanuel Macron, President of France;
Angela Merkel, Chancellor of Germany;
Charles Michel, President of the European Council;
Kyriakos Mitsotakis, Prime Minister of Greece;
Moon Jae-in, President of the Republic of Korea;
Sebastián Piñera, President of Chile;
Andrej Plenković, Prime Minister of Croatia;
Carlos Alvarado Quesada, President of Costa Rica;
Edi Rama, Prime Minister of Albania;
Cyril Ramaphosa, President of South Africa;
Keith Rowley, Prime Minister of Trinidad and Tobago;
Mark Rutte, Prime Minister of the Netherlands;
Kais Saied, President of Tunisia;
Macky Sall, President of Senegal;
Pedro Sánchez, Prime Minister of Spain;
Erna Solberg, Prime Miniser of Norway;
Aleksandar Vučić, President of Serbia;
Joko Widodo, President of Indonesia;
Volodymyr Zelensky, President of Ukraine
Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization.

 

::::::

COVID-19 vaccine and treatment innovators response to global leaders urgent call for international pandemic treaty – IFPMA
30 March 2021
[Editor’s text bolding]
In view of the social and economic impact of current COVID-19 crisis, political leadership in preparing for any eventual future pandemic is crucial. Over the last 12 months we have seen the importance of a strong innovation system and the successful development of several safe and highly effective vaccines in record time. The discussions around a possible International Pandemic Treaty need to take into account the important role played by the innovative biopharmaceutical industry and its supply chain in fighting the virus. It will be important to acknowledge the critical role played by the incentive system in developing tests, therapeutics, and vaccines to contain and defeat the coronavirus. We hope that the discussions on an International Pandemic Treaty will address enablers for future pandemic preparedness – the importance of incentives for future innovation, the immediate and unrestricted access to pathogens, and the importance of the free flow of goods and workforce during the pandemic – in addition to continuing the multi stakeholder approach undertaken in ACT-A and COVAX.
The biopharmaceutical industry and its supply chain is part of the solution for future pandemics and therefore should play a role in shaping an international Pandemic Treaty.
In the short term, in acknowledgement of the current coronavirus crisis, we hope politicians will support the free flow of goods and workforce, acknowledge the unprecedented efforts in collaboration and voluntary tech transfer across vaccine makers from developed and developing countries and show solidarity to ensure the highly effective COVID-19 vaccines reach people so that no one is left behind.

COVID – Europe

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Milestones :: Perspectives :: Research

 

COVID – Europe

WHO: Slow vaccine roll-out prolonging pandemic
Copenhagen, 31 March 2021
As variants of concern continue to spread and strain on hospitals grows, religious holidays are leading to increased mobility. Speeding up vaccination roll-out is crucial as new cases in the WHO European Region are increasing in every age group, apart from one.

Last week saw increasing transmission of COVID-19 in the majority of countries in the WHO European Region, with 1.6 million new cases and close to 24 000 deaths. The Region remains the second most affected by SARS-CoV-2 of all the world’s regions, with the total number of deaths fast approaching 1 million and the total number of cases about to surpass 45 million.

“Only 5 weeks ago, the weekly number of new cases in Europe had dipped to under 1 million, but now the Region’s situation is more worrying than we have seen in several months. There are risks associated with the increased mobility and gatherings over the religious holidays. Many countries are introducing new measures that are necessary and everyone should follow as much as they can,” said Dr Dorit Nitzan, Regional Emergency Director for the WHO Regional Office for Europe.

Across the Region, 50 countries or territories have reported the variant of concern B.1.1.7, initially detected by the United Kingdom and now the predominant variant in the Region. As this variant is more transmissible and can increase the risk of hospitalization, it has a greater public health impact and additional actions are required to control it.

 

Early impact of vaccination
At the European regional level, new cases are increasing in every age group except in people 80 years and older. It is only in this most vulnerable population that we have seen a steady decline in cases and a decreasing proportion of COVID-19 deaths since the beginning of 2021, reflecting early signs of the impact of vaccination.

New data from Public Health England suggest that COVID-19 vaccines have saved, at the very least, over 6000 lives among people over 70 since vaccination started in December 2020. Similarly, data from Israel show that the Pfizer–BioNTech vaccine is around 90% effective at preventing infection, severe disease and hospitalization after the second dose.

“Vaccines present our best way out of this pandemic. Not only do they work, they are also highly effective in preventing infection. However, the roll-out of these vaccines is unacceptably slow. And as long as coverage remains low, we need to apply the same public health and social measures as we have in the past, to compensate for delayed schedules. Let me be clear: we must speed up the process by ramping up manufacturing, reducing barriers to administering vaccines, and using every single vial we have in stock, now,” said Dr Hans Henri P. Kluge, WHO Regional Director for Europe…

 

Curbing spread
As the largest numbers of new COVID-19 cases are occurring in population groups that are not yet vaccinated, WHO continues to call for early action to implement public health and social measures on the basis of epidemiological and health system data while vaccination coverage continues to grow.
A total of 27 countries in the Region are in partial or full nationwide lockdown, with 21 imposing nighttime curfews. In the past 2 weeks, 23 countries have intensified restrictions while 13 have eased measures, with an additional 9 to follow suit.

Although so-called lockdowns should be avoided by timely and targeted public health interventions, they should be used when the disease overstretches the ability of health services to care for patients adequately, and to accelerate the readiness of local and national public health systems.

“The likelihood of new variants of concern occurring increases with the rate at which the virus is replicating and spreading, so curbing transmission through basic disease control actions is crucial. And today, as opposed to a year ago, we have better test and trace systems, faster information-sharing, and we know much more about how to care for the severely ill,” said Dr Nitzan.

Expanded testing, isolation, contact tracing, quarantine and genetic sequencing are the basic public health tools that must be used and continually strengthened.

 

Heed the danger
Vaccination together with continued public health and social measures will eventually bring an end to the pandemic. For that to happen, a scale-up of both vaccine production and vaccination is required, as well as continued adherence to public health and social measures.

“The greatest determinant of how many people get infected and how many people die in the coming weeks is what you as an individual do – or don’t do. We have seen it time and time again: virus spread can be stopped. My message to governments in the Region is therefore that now is not the time to relax measures. We can’t afford not to heed the danger. We have all made sacrifices, but we cannot let exhaustion win. We must keep reining in the virus,” Dr Kluge concluded.

 

::::::

European Union: Commission Amends Authorization Mechanism for Exports of COVID-19 Vaccines
(Apr. 1, 2021) On March 26, 2021, the European Commission’s Implementing Regulation (EU) 2021/521, which amends the authorization mechanism for exports of COVID-19 vaccines adopted on January 30, 2021, entered into force. The regulation adds the principles of reciprocity and proportionality as new criteria to be considered when a European Union (EU) member state authorizes exports.
EU Regulations are binding in their entirety and directly applicable in all EU member states. (Treaty on the Functioning of the European Union art. 288, para. 2.)
In announcing the new regulation, the President of the European Commission, Ursula von der Leyen, remarked: “[O]pen roads should run in both directions. . . . The EU has an excellent portfolio of different vaccines and we have secured more than enough doses for the entire population. But we have to ensure timely and sufficient vaccine deliveries to EU citizens. Every day counts.”…
Global Legal Monitor
Author: Jenny Gesley
Date: April 1, 2021

COMMISSION IMPLEMENTING REGULATION (EU) 2021/521 of 24 March 2021 …making specific arrangements to the mechanism making the exportation of certain products subject to the production of an export authorisation
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2015/479 of the European Parliament and of the Council of 11 March 2015 on common rules for exports(1), and in particular Article 5 thereof,

Whereas:
(1) On 30 January 2021, the Commission adopted Implementing Regulation (EU) 2021/111(2) making the exportation of COVID-19 vaccines as well as active substances, including master and working cell banks, used to manufacture these vaccines, subject to the production of an export authorisation, pursuant to Article 5 of Regulation (EU) 2015/479. At the end of the six weeks period following the date of entry into force of these measures, the Commission adopted Implementing Regulation (EU) 2021/442(3) making the exportation of the same products subject to an export authorisation until 30 June 2021, pursuant to Article 6 of Regulation (EU) 2015/479.

(2) The global shortage of supply of COVID-19 vaccine persists and is even increasing in view of the delays of production.

 

(3) In accordance with Implementing Regulation (EU) 2021/442, export authorisations are to be refused by the Member States where the exports concerned pose a threat to the execution of the Advanced Purchase Agreements (APAs) between the Union and vaccine manufacturers in view of their volume or other relevant circumstances, such as the volume of vaccines delivered to the Union at the time of the request.

(4) There is still a lack of transparency as well as persisting constraints on production of COVID 19 vaccines and delays in their delivery in the Union, which may pose a threat to the security of supply within the Union of the goods covered by Implementing Regulation (EU) 2021/442. Additional elements should therefore also be considered in the decision to grant or refuse an export authorisation.

(5) The information collected by the Commission through the export authorisation mechanism put in place by Implementing Regulation (EU) 2021/111 and continued by Implementing Regulation (EU) 2021/442 and through customs data has shown that exports which are subject to the authorisation mechanism may be channelled via countries so far exempted from the export authorisation requirement, thereby not allowing for the required level of transparency. These exemptions should therefore be temporarily suspended.

(6) The exemption should be maintained for some of the countries and territories mentioned Article 1(9)(a) of Implementing Regulation (EU) 2021/442, namely those which have a particular dependency on the metropolitan supply chains of the Member States to which they are attached or on the supply chains of neighbouring Member States, respectively.

(7) The information mentioned in recital (5) has also shown that Union manufacturers have exported large quantities of goods covered by the export authorisation mechanism to countries which have a large production capacity of their own, while those countries restrict their own exports to the Union, either by law or through contractual or other arrangements concluded with vaccine manufacturers established in their territory. This imbalance leads to shortages of supply within the Union. ENOfficial Journal of the European Union L 104/52 25.3.2021

(8) Furthermore, the same information has shown that Union manufacturers have exported large quantities of goods covered by the export authorisation mechanism to certain countries without production capacity, but which have a higher vaccination rate than the Union or where the current epidemiological situation is less serious than in the Union. Exports to those countries may thus threaten the security of supply within the Union.

 

(9) Member States should refuse export authorisations accordingly.

(10) The Commission should take the same additional elements into consideration when conducting its assessment of the draft decision notified by the competent authority of the Member State pursuant to Article 2(4) of Implementing Regulation (EU) 2021/442.

(11) Due to the urgency of the situation, the measures provided for in this Regulation should be taken in accordance with Article 3(3) of Regulation (EU) 2015/479.

 

(12) This Regulation should enter into force immediately. Having regard to Article 5(5) of Regulation (EU) 2015/479, the measures provided for in this Regulation should apply for six weeks,

HAS ADOPTED THIS REGULATION:
Article 1 The application of point (a) of Article 1(9) of Implementing Regulation (EU) 2021/442 is suspended. However, the suspension shall not apply to the following countries and territories: — Andorra, — the Faroe Islands, — San Marino, — Vatican City, — the overseas countries and territories listed in Annex II to the Treaty on the Functioning of the European Union, — Büsingen, — Helgoland, — Livigno, — Ceuta and Melilla.

Article 2 1.The competent authority of a Member State shall grant an export authorisation requested pursuant to Implementing Regulation (EU) 2021/442 provided that:
(a) the export authorisation fulfils the condition of Article 1(7) of Implementing Regulation (EU) 2021/442;
(b) the authorisation does not otherwise pose a threat to the security of supply within the Union of the goods covered by Implementing Regulation (EU) 2021/442.

2.To determine whether the condition in point (b) of paragraph 1 is fulfilled, the competent authority of the Member State shall assess the following factors:
(a) whether the country of destination of the export restricts its own exports to the Union of goods covered by Implementing Regulation (EU) 2021/442, or of the raw materials from which they are made, either by law or by any other means, including through the conclusion of contractual arrangements with the manufacturers of those goods;
(b) the relevant conditions prevailing in the country of destination of the export, including the epidemiological situation, the vaccination rate and the existing availability of goods covered by Implementing Regulation (EU) 2021/442. ENOfficial Journal of the European Union 25.3.2021 L 104/53

3.When the Commission assesses the draft decision notified by the competent authority of the Member State pursuant to Article 2(4) of Implementing Regulation (EU) 2021/442, it shall also evaluate whether the condition in point (b) of paragraph 1 of this Article is fulfilled, having regard to the factors listed in its paragraph 2.

Article 3 This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply until six weeks from its entry into force.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24 March 2021. For the Commission The President Ursula VON DER LEYEN EN Official Journal of the European Union L 104/54 25.3.2021

(1)OJ L 83, 27.3.2015, p. 34.(2)Commission Implementing Regulation (EU) 2021/111 of 29 January 2021 making the exportation of certain products subject to the production of an export authorisation (OJ L 31 I, 30.1.2021, p. 1).(3)Commission Implementing Regulation (EU) 2021/442 of 11 March 2021 making the exportation of certain products subject to the production of an export authorisation (OJ L 85, 12.3.2021, p. 190).

 

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COVID-19 Origins – WHO International Team Report

WHO calls for further studies, data on origin of SARS-CoV-2 virus, reiterates that all hypotheses remain open
30 March 2021 News release Geneva, Switzerland
The report of the international team on their Wuhan field visit, from 14 January -10 February 2021, was published today as WHO Director-General Dr Tedros Adhanom Ghebreyesus called for further studies.

The report stems from a Member State resolution adopted by consensus at the World Health Assembly in May 2020 and calling on WHO “to identify the zoonotic source of the virus and the route of introduction to the human population, including the possible role of intermediate hosts, including through efforts such as scientific and collaborative field missions.”

In remarks to Member States today, Dr Tedros, who received the full report on the weekend, thanked the team for their tireless work. He said it advances our understanding in important ways, while raising questions that will need to be addressed by further studies, as noted in the report. “As far as WHO is concerned, all hypotheses remain on the table. This report is a very important beginning, but it is not the end. We have not yet found the source of the virus, and we must continue to follow the science and leave no stone unturned as we do,” said Dr Tedros. “Finding the origin of a virus takes time and we owe it to the world to find the source so we can collectively take steps to reduce the risk of this happening again. No single research trip can provide all the answers.”

The report is available on this webpage:
https://www.who.int/health-topics/coronavirus/origins-of-the-virus

Below is the full text of the Director-General’s remarks that can be found here:
https://www.who.int/director-general/speeches/detail/who-director-general-s-remarks-at-the-member-state-briefing-on-the-report-of-the-international-team-studying-the-origins-of-sars-cov-2

 

Background information
From the very beginning of the pandemic WHO has stressed the need to understand the origin of the virus in order to better understand the emergence of new pathogens and possible exposures.

Only a few weeks into the outbreak, the IHR Emergency Committee of independent experts recommended that WHO and China pursue efforts to identify the animal source of the virus.

Throughout 2020, WHO continued to discuss with China and other Member States the need to study and share information around the virus origins.

The World Health Assembly resolution of May 2020, which was adopted by all Member States, cited a need “to identify the zoonotic source”:
WHA73.1 from 19 May 2020: 9. (6) to continue to work closely with the World Organisation for Animal Health (OIE), the Food and Agriculture Organization of the United Nations (FAO) and countries, as part of the One-Health Approach to identify the zoonotic source of the virus and the route of introduction to the human population, including the possible role of intermediate hosts, including through efforts such as scientific and collaborative field missions, which will enable targeted interventions and a research agenda to reduce the risk of similar events occurring, as well as to provide guidance on how to prevent infection with severe acute respiratory syndrome coronavirus 2 (SARS-COV2) in animals and humans and prevent the establishment of new zoonotic reservoirs, as well as to reduce further risks of emergence and transmission of zoonotic diseases;

In July 2020 WHO sent a small team to China to plan a joint study comprising Chinese and independent international scientists.

It was agreed that WHO would select the international scientists. The Terms of Reference for the Virus Origins Study were completed by fall 2020.
Terms of reference of the Global Study of the Origins of SARS-COV2

The team of scientists came from around the world: Australia, China, Denmark, Germany, Japan, Kenya, Netherlands, Qatar, the Russian Federation, the United Kingdom, the United States of America and Viet Nam. The joint international team comprised 17 Chinese and 17 international experts from 10 other countries as well as the World Organization for Animal Health (OIE); and WHO.  Find the list of the members of the international team here.

From the outset, this study was designed as one step on the path of understanding the origins of COVID-19 reflecting the specific scope and mandate as outlined by Member States in the World Health Assembly resolution and negotiated Terms of Reference.