Category Archives: Uncategorized

Development and dissemination of infectious disease dynamic transmission models during the COVID-19 pandemic: what can we learn from other pathogens and how can we move forward?

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Lancet Digital Health
Jan 2021 Volume 3 Number 1 e1-e66
https://www.thelancet.com/journals/landig/issue/current

 

Review
Development and dissemination of infectious disease dynamic transmission models during the COVID-19 pandemic: what can we learn from other pathogens and how can we move forward?
Alexander D Becker, yra H Grantz, Sonia T Hegde, Sophie Bérubé, Derek A T Cummings, Amy Wesolowski

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial

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Lancet Infectious Diseases
Jan 2021 Volume 21 Number 1 p1-148, e1-e16
https://www.thelancet.com/journals/laninf/issue/current

 

Articles
Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial
Shengli Xia, et al

Indirect effects of the COVID-19 pandemic on malaria intervention coverage, morbidity, and mortality in Africa: a geospatial modelling analysis

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Lancet Infectious Diseases
Jan 2021 Volume 21 Number 1 p1-148, e1-e16
https://www.thelancet.com/journals/laninf/issue/current

 

Indirect effects of the COVID-19 pandemic on malaria intervention coverage, morbidity, and mortality in Africa: a geospatial modelling analysis
Daniel J Weiss, et al
Open Access

Epidemiology of varicella among immigrants and non-immigrants in Quebec, Canada, before and after the introduction of childhood varicella vaccination: a retrospective cohort study

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Lancet Infectious Diseases
Jan 2021 Volume 21 Number 1 p1-148, e1-e16
https://www.thelancet.com/journals/laninf/issue/current

 

Epidemiology of varicella among immigrants and non-immigrants in Quebec, Canada, before and after the introduction of childhood varicella vaccination: a retrospective cohort study
Christina Greenaway, et al

Dynamic changes in paediatric invasive pneumococcal disease after sequential switches of conjugate vaccine in Belgium: a national retrospective observational study

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Lancet Infectious Diseases
Jan 2021 Volume 21 Number 1 p1-148, e1-e16
https://www.thelancet.com/journals/laninf/issue/current

Dynamic changes in paediatric invasive pneumococcal disease after sequential switches of conjugate vaccine in Belgium: a national retrospective observational study
Stefanie Desmet, et al

Invasive pneumococcal disease incidence in children and adults in France during the pneumococcal conjugate vaccine era: an interrupted time-series analysis of data from a 17-year national prospective surveillance study

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Lancet Infectious Diseases
Jan 2021 Volume 21 Number 1 p1-148, e1-e16
https://www.thelancet.com/journals/laninf/issue/current

 

Invasive pneumococcal disease incidence in children and adults in France during the pneumococcal conjugate vaccine era: an interrupted time-series analysis of data from a 17-year national prospective surveillance study
Naïm Ouldali, et al

Ethical and Legal Implications of Remote Monitoring of Medical Devices

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The Milbank Quarterly
A Multidisciplinary Journal of Population Health and Health Policy

Ethical and Legal Implications of Remote Monitoring of Medical Devices
I. GLENN COHEN, SARA GERKE, DANIEL B. KRAMER

 

Pages: 1257-1289
First Published: 20 October 2020
Abstract
Policy Points
:: Millions of life‐sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user‐downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers.
:: Our analysis of health privacy laws indicates that most US patients may have little access to their own digital health data in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation and the California Consumer Privacy Act grant greater access to device‐collected data.
:: Our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices.

A Commons for a Supply Chain in the Post‐COVID‐19 Era: The Case for a Reformed Strategic National Stockpile

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The Milbank Quarterly
A Multidisciplinary Journal of Population Health and Health Policy

 

Volume 98, Issue 4 Pages: 1021-1341, E1-E12 December 2020
https://onlinelibrary.wiley.com/toc/14680009/current
Original Scholarship
Free Access
A Commons for a Supply Chain in the Post‐COVID‐19 Era: The Case for a Reformed Strategic National Stockpile
ROBERT HANDFIELD, DANIEL JOSEPH FINKENSTADT, EUGENE S. SCHNELLER, A. BLANTON GODFREY
PETER GUINTO
Pages: 1058-1090
First Published: 02 November 2020

Genetics meets proteomics: perspectives for large population-based studies

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Nature Reviews Genetics
Volume 22 Issue 1, January 2021
https://www.nature.com/nrg/volumes/22/issues/1

 

Review Article | 28 August 2020
Genetics meets proteomics: perspectives for large population-based studies
In this Review, Suhre, McCarthy and Schwenk describe how combining genetics with plasma proteomics is providing notable insights into human disease. As changes in the circulating proteome are often an intermediate molecular readout between a genetic variant and its organismal effect, proteomics can enable a deeper understanding of disease mechanisms, clinical biomarkers and therapeutic opportunities.
Karsten Suhre , Mark I. McCarthy  & Jochen M. Schwenk

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

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New England Journal of Medicine
December 31, 2020 Vol. 383 No. 27
http://www.nejm.org/toc/nejm/medical-journal

 

Original Articles
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Fernando P. Polack, M.D., et al for the C4591001 Clinical Trial Group
Conclusions
A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728)

Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine

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Pediatrics
Vol. 147, Issue 1 1 Jan 2021
https://pediatrics.aappublications.org/

 

Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine
Jacob Bornstein, Surita Roux, Lone Kjeld Petersen, Li-Min Huang, Simon R. Dobson, Punnee Pitisuttithum, Javier Diez-Domingo, Andrea Schilling, Hany Ariffin, Richard Tytus, Richard Rupp, Shelly Senders, Eli Engel, Daron Ferris, Yae-Jean Kim, Young Tae Kim, Zafer Kurugol, Oliver Bautista, Katrina M. Nolan, Sandhya Sankaranarayanan, Alfred Saah, Alain Luxembourg
Pediatrics, Jan 2021, 147 (1) e20194035

Comparative efficacy and safety of pharmacological interventions for the treatment of COVID-19: A systematic review and network meta-analysis

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PLoS Medicine
http://www.plosmedicine.org/

 

Research Article |
Comparative efficacy and safety of pharmacological interventions for the treatment of COVID-19: A systematic review and network meta-analysis
Min Seo Kim, Min Ho An, Won Jun Kim, Tae-Ho Hwang
published 30 Dec 2020 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1003501

Parents’ and guardians’ views and experiences of accessing routine childhood vaccinations during the coronavirus (COVID-19) pandemic: A mixed methods study in England

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PLoS One
http://www.plosone.org/
[Accessed 2 Jan 2021]

 

Parents’ and guardians’ views and experiences of accessing routine childhood vaccinations during the coronavirus (COVID-19) pandemic: A mixed methods study in England
Sadie Bell, Richard Clarke, Pauline Paterson, Sandra Mounier-Jack
Research Article | published 28 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0244049

Science’s irrational origins

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Science
01 January 2021 Vol 371, Issue 6524
http://www.sciencemag.org/current.dtl

 

Books et al.
Science’s irrational origins
By Itai Yanai, Martin J. Lercher
Science01 Jan 2021 : 37 Restricted Access
Disputes in modern science are settled with empiricism alone, an approach early scholars would have questioned
Summary
What is the scientific method, and what makes it the most efficient approach for generating insight? In The Knowledge Machine, Michael Strevens argues that to answer this question, we must acknowledge the role played by the undisciplined and emotional nature of the humans who carry it out. The book takes readers on a whirlwind tour through the history of science, rendering Arthur Eddington, Louis Pasteur, G. G. Simpson, Lord Kelvin, and many others as “warm-blooded organisms, whose enthusiasms, hopes, and fears mold their thinking far below the threshold of awareness.”

Mobile phone reminders for enhancing uptake, completeness and timeliness of routine childhood immunization in low and middle income countries: A systematic review and meta-analysis

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Vaccine
Volume 39, Issue 2 Pages 167-456 (8 January 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/2

 

Review article Abstract only
Mobile phone reminders for enhancing uptake, completeness and timeliness of routine childhood immunization in low and middle income countries: A systematic review and meta-analysis
Umar Yunusa, Saleh Ngaski Garba, Addakano Bello Umar, Suleiman Hadejia Idris, … Jibril Mohammed
Pages 209-221

Public health impact and cost-effectiveness of a nine-valent gender-neutral HPV vaccination program in France

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Vaccine
Volume 39, Issue 2 Pages 167-456 (8 January 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/2

 

Research article Abstract only
Public health impact and cost-effectiveness of a nine-valent gender-neutral HPV vaccination program in France
Laureen Majed, Xavier Bresse, Nadia El Mouaddin, Aurélie Schmidt, … Elamin Elbasha
Pages 438-446

Confidence and Receptivity for COVID-19 Vaccines: A Rapid Systematic Review

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Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 2 Jan 2021)

 

Open Access Review
Confidence and Receptivity for COVID-19 Vaccines: A Rapid Systematic Review
by Cheryl Lin, Pikuei Tu and Leslie M. Beitsch
Vaccines 2021, 9(1), 16; https://doi.org/10.3390/vaccines9010016 – 30 Dec 2020
Abstract
While COVID-19 continues raging worldwide, effective vaccines are highly anticipated. However, vaccine hesitancy is widespread. Survey results on uptake intentions vary and continue to change. This review compared trends and synthesized findings in vaccination receptivity over time across US and international polls, assessing […]

Genomic Medicine and Advances in Vaccine Technology and Development in the Developing and Developed World

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Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 2 Jan 2021)

 

Open Access Editorial
Genomic Medicine and Advances in Vaccine Technology and Development in the Developing and Developed World
by Rossella Cianci and Laura Franza
Vaccines 2021, 9(1), 9; https://doi.org/10.3390/vaccines9010009 – 24 Dec 2020

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 Atlantic
http://www.theatlantic.com/magazine/
Accessed 2 Jan 2021
Ideas
Growing Old, Alone
Isolation has taken a tremendous emotional toll on many older Americans.
2 Jan 2021
Annie Lowrey
Staff writer at The Atlantic
As the country plunged into a deep and unusual economic recession last year, it also plunged into a deep and unusual social recession: atomizing families and friends, evaporating hours of laughter and care and touch.
This phenomenon hit nobody as hard as America’s seniors, who are much more likely than their younger counterparts to live in care facilities and many of whom have struggled to connect in a socially distanced or virtual fashion. The elderly bore the brunt of the pandemic’s fatalities: COVID-19 has killed nearly 250,000 people over the age of 65. They also bore the brunt of its isolation. Many older Americans spent months discriminated against, frightened, and alone…

 

BBC
http://www.bbc.co.uk/
Accessed 2 Jan 2021
Covid vaccine in Wales: Doctors’ concerns over 12-week vaccine gap
Health workers are “not certain that they are being adequately protected” with a longer gap between receiving two doses of the Covid vaccine, a doctors’ leader has said.
David Bailey, chairman of the British Medical Association in Wales, said morale had taken a “hit” as a result.
The Welsh Government said it was following advice on introducing a 12-week gap between doses.
All four chief medical officers in the UK have backed the move…

 

The Economist
http://www.economist.com/
Accessed 2 Jan 2021
Sputnik’s orbit
Argentina rolls out a Russian vaccine
The decision to use Sputnik V may have more to do with geopolitics than public health
Jan 2nd 2021 edition
On December 29th Argentina’s government unleashed Sputnik V across the country, issuing some 300,000 doses to all 23 provinces and the city of Buenos Aires. Elsewhere in Latin America, Mexico, Chile, and Costa Rica had been vaccinating on a small scale before the holiday with the Pfizer-BioNTech vaccine. But Argentina, to quote a presidential adviser, “is leading the charge to inoculate all”.
Still, the cavalry has been met with doubts. Alberto Fernández, Argentina’s 61-year-old president, broke his promise to be the country’s first recipient, live on television, after Russia’s president, Vladimir Putin, who is 68, said he would put off his jab because of his age. Then Mr Fernández’s government sidestepped the normal procedures of its medical regulatory agency, ANMAT, in authorising Sputnik V.
On the eve of the vaccine’s launch, ANMAT specialists leaked internal memos to the Argentine media, expressing concerns about “adverse effects” of Sputnik V on older patients in trials in Russia. Warnings of “symptoms like influenza” got front-page headlines, though these are common with many vaccines.
Unsurprisingly, Sputnik V has become a political football. Alfredo Cornejo, leader of the Radical party, alleged corruption, suggesting that officials’ demands for bribes had scuppered deals with other producers in Europe and the United States…

 

Financial Times
https://www.ft.com/
Accessed 2 Jan 2021
Coronavirus treatment
UK draws up plans to mix coronavirus vaccines
In event that first dose becomes unavailable people could be given second shot with different product
January 2, 2021
The UK has drawn up plans that would allow patients to be given different coronavirus vaccines for the first and second doses under certain circumstances, a move that highlights a widening rift in public health policy between the UK and rest of the West.
The government’s Green Book for vaccinations says “every effort” should be made to complete the immunisation course with the same vaccine. But it also says: “For individuals who started the schedule and who attend for vaccination at a site where the same vaccine is not available, or if the first product received is unknown, it is reasonable to offer one dose of the locally available product to complete the schedule.”
Health officials said this would only happen under very limited circumstances.
Mary Ramsay, Head of Immunisations at PHE, said mixing Covid-19 vaccines was not recommended. “If your first dose is the Pfizer vaccine you should not be given the AstraZeneca vaccine for your second dose and vice versa.
“There may be extremely rare occasions where the same vaccine is not available, or where it is not known what vaccine the patient received,” Dr Ramsay said. “Every effort should be made to give them the same vaccine, but where this is not possible it is better to give a second dose of another vaccine than not at all…

Coronavirus pandemic
European leaders under pressure to speed up mass vaccination
Slow pace of immunisation criticised while jab makers warn of supply bottlenecks
January 1, 2021
Top of Form
Bottom of Form

Coronavirus treatment
Experts question UK decision on Covid vaccine dosing regimen
Health authorities argue that broader, if slightly lower, immunity for more people is needed
January 1, 2021

 

Forbes
http://www.forbes.com/
2 Jan 2020
Large Numbers Of Health Care And Frontline Workers Are Refusing Covid-19 Vaccine
Topline
Despite the Covid-19 death count in the United States rapidly accelerating, a startlingly high percentage of health care professionals and frontline workers throughout the country—who have been prioritized as early receipts of the coronavirus vaccine—are reportedly hesitant or outright refusing to take it, despite clear scientific evidence that the vaccines are safe and effective.
By Tommy Beer Forbes Staff

Coronavirus  |  
Dec 31, 2020
Trump Administration Has Reached Only 7% Of Its 2020 Covid-19 Vaccination Goals
Has Operation Warp Speed been Operation Too Slow Speed when it has come to getting people vaccinated with Covid-19 vaccines?
By Bruce Y. Lee Senior Contributor

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 2 Jan 2021
Snapshot December 31, 2020
How U.S. Pandemic Restrictions Became a Constitutional Battlefield
After 100 Years, Public Health Controls Are Under Attack
John Fabian Witt and Kiki Manzur

Snapshot December 29, 2020
Vaccine Nationalism Will Prolong the Pandemic
A Global Problem Calls for Collective Action
Thomas J. Bollyky and Chad P. Bown

 

Foreign Policy
http://foreignpolicy.com/
Accessed 2 Jan 2021
Analysis
The World After the Coronavirus
As the pandemic enters a new phase, we asked 12 leading global thinkers to predict what happens in 2021 and beyond.
By John R. Allen, Laurie Garrett, Richard N. Haass, G. John Ikenberry, Kishore Mahbubani, Shivshankar Menon, Robin Niblett, Joseph S. Nye Jr., Shannon K. O’Neil, Kori Schake, Anne-Marie Slaughter, Stephen M. Walt
January 2, 2021, 6:00 AM

 

The Guardian
http://www.guardiannews.com/
Accessed 2 Jan 2021
[No new, unique, relevant content]

 

New Yorker
http://www.newyorker.com/
Accessed 2 Jan 2021
Brazil death toll passes 195,000 in world’s third worst outbreak …
1 Jan 2021

India approves Oxford/AstraZeneca Covid vaccine | India | The …
1 Jan 2021
Country with second-highest number of infections has run vaccine drills to prepare for immunisation campaign.

 

New York Times
http://www.nytimes.com/
Accessed 2 Jan 2021
World
Under fire, the Netherlands is speeding up the start of its lagging vaccination campaign.
The government said that shots would begin sooner than Jan. 8, and that it would announce the new start date on Monday.
By Thomas Erdbrink
Jan. 1, 2021

World
Israel has vaccinated more of its population, by far, than any other country in the world.
By Isabel Kershner
Jan. 1, 2021

Dr. Fauci advises against the British approach of delaying a second dose of vaccine.
Jan. 1, 2021
By Katherine J. Wu
Dr. Anthony S. Fauci, the nation’s top infectious disease expert, told CNN on Friday that the United States would not follow Britain’s lead in front-loading first vaccine injections, potentially delaying the administration of second doses.
Britain announced a plan this week to delay second shots of its two authorized vaccines, developed by Pfizer and AstraZeneca, in an attempt to dole out to more people the partial protection conferred by a single dose.
“I would not be in favor of that,” Dr. Fauci told CNN’s Elizabeth Cohen. “We’re going to keep doing what we’re doing.”…

World

The U.S. enters 2021 playing catch-up with its vaccine distribution, prompting sharp words from Mitt Romney.
Jan. 1, 2021
By Rebecca Robbins, Frances Robles and Tim Arango

U.S.
AstraZeneca and Sinopharm clear regulatory hurdles in a week of vaccine milestones.
By Katherine J. Wu

Health
U.S. Officials Say Covid-19 Vaccination Effort Has Lagged
“We know that it should be better, and we’re working hard to make it better,” said Moncef Slaoui, a leader of the federal effort to accelerate vaccine development and distribution.
By Rebecca Robbins
Dec. 30, 2020

 

Washington Post
https://www.washingtonpost.com/
Accessed 2 Jan 2021
How Vaccine Nationalism Could Extend the Pandemic’s Run
By James Paton | Bloomberg
Dec 26, 2020

Pope on COVID-19 vaccine: Needy, vulnerable must come first
Dec 25, 2020

Vaccine opponents outline online campaigns to sow distrust in coronavirus vaccine
The pandemic has catalyzed anti-vaccine advocates with huge social media followings, new report finds
Elizabeth Dwoskin · Technology · Dec 23, 2020

Think Tanks et al

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Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 2 Jan 2021
[No new relevant content]

Center for Global Development [to 2 Jan 2021]
http://www.cgdev.org/page/press-center
[No new relevant content]

 

Chatham House [to 2 Jan 2021]
https://www.chathamhouse.org/
Accessed 2 Jan 2021
[No new relevant content]

 

CSIS
https://www.csis.org/
Accessed 2 Jan 2021
Upcoming Event
Online Event: Trusting a Covid-19 Vaccine: Who’s Left Unheard?
January 8, 2021

 

Council on Foreign Relations
http://www.cfr.org/
Accessed 2 Jan 2021
December 29, 2020 Coronavirus
Resurgence of COVID-19 in Africa
South Africa is once again the epicenter of the current wave of infections, driven, apparently, by a mutant strain of the virus. According to health experts, South Africa now accounts for an estimated 40 percent of COVID-19 cases in Africa.
Blog Post by John Campbell

 

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 2 Jan 2021
[No new relevant content]

Vaccines and Global Health: The Week in Review :: 26 December 2020

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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_26-dec-2020Download

– 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

Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – 5 January 2021

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Milestones :: Perspectives :: Research

Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – 5 January 2021

5 January 2021 10:00 – 17:00 CET

This extraordinary virtual meeting for the Strategic Advisory Group of Experts on Immunization (SAGE) will be held on Tuesday 05 January 2021 to propose recommendations to WHO on the use of COVID-19 vaccine(s).

Meeting materials

Materials for this meeting such as a provisional list of participants and background documents will be made available nearer the time.

Draft Meeting Agenda  [see image below]

Draft Summary of Declaration of Interests

Background documents for the Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – 5 January 2021

:: mRNA vaccines against COVID-19: Pfizer-BioNTech COVID-19 vaccineBNT162b2

   Draft document – Prepared by the Strategic Advisory Group of Experts (SAGE) on Immunization Working Group on COVID-19 vaccines

22 December 2020  | Technical document

WHO Reference Number: WHO/2019-nCoV/vaccines/SAGE_evaluation/BNT162b2/2020.1

Download

:: Background paper on Covid-19 disease and vaccines

   Draft document – Prepared by the Strategic Advisory Group of Experts (SAGE) on Immunization Working Group on COVID-19 vaccines

22 December 2020  | Technical document

WHO Reference Number: WHO/2019-nCoV/vaccines/SAGE_background/2020.1

Download

::::::

WHO – Planned COVID-19 Vaccine Effectiveness and Impact Studies: Request for Information

22 December 2020 

Call for submissions

   After COVID-19 vaccines are introduced into countries, it will be vital to generate real-world data on vaccine effectiveness and vaccine impact, as many questions will remain unanswered by the clinical trials.   Studies will likely be done in a variety of countries, in a variety of populations, and using a variety of study designs.  

   As part of our scoping of the landscape to understand the future availability of data to inform global policy and the gaps that need to be filled, we invite researchers to provide information about their planned work on COVID-19 vaccination effectiveness and/or impact studies.  This can be done by filling out this electronic form with relevant details. This form will take less than 5 minutes  of your time.

   Data provided will be used by the Strategic Advisory Group of Experts on Immunization to understand what data will be available and when it will be available  to update their global policy recommendations. 

   Initial responses are requested as soon as possible. This will be an ongoing process, where updates can be provided in the future as plans change or studies are implemented.  

   Basic information such as country of study or study design will be made available through the WHO website to highlight the landscape of studies being undertaken. 

   Please provide preliminary responses by January 15, 2021. Future requests for information will be posted as we know plans are fluid. 

   Questions can be addressed to covidve@who.int

COVID Vaccines: Development/Regulatory Actions/Procurement/Deployment

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Milestones :: Perspectives :: Research

 

COVID Vaccines: Development/Regulatory Actions/Procurement/Deployment

Pfizer and BioNTech to Supply the U.S. with 100 Million Additional Doses of COVID-19 Vaccine
December 23, 2020
:: U.S. government orders 100 million additional doses of the Pfizer-BioNTech COVID-19 Vaccine bringing total doses for U.S. to 200 million
:: All 200 million doses expected to be delivered by July 31, 2021, allowing for 100 million people in the U.S. to be vaccinated

Serum Institute Of India And Dynavax Announce First Participants Dosed In The Phase 1/2 Clinical Trial For A COVID-19 Vaccine
PUNE, India and EMERYVILLE, Calif., Dec. 23, 2020 /PRNewswire/ — Further strengthening its fight against COVID-19, Serum Institute of India (SIIPL), the world’s largest vaccine manufacturer by volume, has partnered with Dynavax Technologies Corporation (Nasdaq: DVAX) a biopharmaceutical company focused on developing and commercializing novel vaccines, and today jointly announced that the first participants have been dosed in the Phase 1 part of the Phase 1/2 clinical trial evaluating SIIPL’s vaccine candidate adjuvanted with CpG 1018 to prevent COVID-19.
The Phase 1/2 clinical trial will evaluate the safety and immunogenicity of SIIPL’s vaccine candidate consisting of the SARS-COV-2 virus receptor binding domain (RBD) delivered as a virus-like particle (VPL), along with Dynavax’s advanced adjuvant CpG 1018 plus alum. The Phase 1 portion of the clinical trial will enroll 39 healthy volunteers and post the completion of the study a decision will be taken regarding the dosing of up to 216 subjects in Phase 2…

EMA recommends first COVID-19 vaccine for authorisation in the EU (updated)
CHMP December 22, 2020
EMA has recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. EMA’s scientific opinion paves the way for the first marketing authorisation of a COVID-19 vaccine in the EU by the European Commission, with all the safeguards, controls and obligations this entails.

EMA’s human medicines committee (CHMP) has completed its rigorous evaluation of Comirnaty, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation. This will provide a controlled and robust framework to underpin EU-wide vaccination campaigns and protect EU citizens.

“Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many,” said Emer Cooke, Executive Director of EMA. “We have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU Member States.

“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards. However, our work does not stop here. We will continue to collect and analyse data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU.”…

Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine
:: COMIRNATY® (also known as BNT162b2) receives conditional marketing authorization from the European Commission; this milestone represents a global joint effort to advance the first authorized mRNA vaccine
:: Pfizer and BioNTech are ready to immediately ship initial doses to the 27 EU member states
Pfizer and BioNTech previously announced an agreement with the European Commission to supply 200 million vaccine doses to EU member states; the EU also has an option to purchase an additional 100 million doses in 2021
:: The vaccine has now been granted a conditional marketing authorization, emergency use authorization, or temporary authorization in more than 40 countries worldwide, including all 27 EU member states
December 21, 2020 NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the European Commission (EC) has granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for COMIRNATY® (also known as BNT162b2), for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine earlier today. The EC granted this CMA in the interest of public health to help address the COVID-19 pandemic. The CMA is valid in all 27 member states of the European Union (EU)…

RDIF, The Gamaleya National Center, AstraZeneca and R-Pharm sign an agreement to cooperate on COVID-19 vaccine development
MOSCOW, Dec. 21, 2020 /PRNewswire/ — The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), The Gamaleya National Center, AstraZeneca and R-Pharm have signed an agreement aimed at the development and implementation of a clinical research program to assess the immunogenicity and safety of the combined use of one of the components of the Sputnik V vaccine developed by the Gamaleya Center, and one of the components of the AZD1222 vaccine, developed by AstraZeneca and the University of Oxford.
The agreement was announced on a video-conference with Vladimir Putin, the President of Russia.
The parties have also agreed to develop scientific and business relations and explore the possibilities for joint use of the Sputnik V vaccine and the AZD1222 vaccine in order to create more effective and long-term immunization against potential new coronavirus infections.
Clinical trials of the combination of AZD1222 vaccine with Sputnik V’s human adenoviral vector type Ad26 will begin soon. R-Pharm will be among the organizations funding the trial…

COVID Vaccines Development/Procurement/Distribution/Policy – Russia, China

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Milestones :: Perspectives :: Research

 

COVID Vaccines Development/Procurement/Distribution/Policy – Russia, China

Sputnik V – “the first registered COVID-19 vaccine” [to 26 Dec 2020]
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
First batch of 300,000 doses of Sputnik V vaccine delivered to Argentina
Press release, 24.12.2020

Argentina has registered the Sputnik V vaccine based on Russian clinical trial data
Press release, 23.12.2020
…Argentina was the first country in Latin America to officially register Sputnik V. The vaccine was registered under the emergency use authorization procedure and was approved by the regulator, ANMAT [National Administration of Drugs, Foods and Medical Devices of Argentina] based on the results of Phase III clinical trials in Russia, without additional trials in Argentina…

Production of Russian Sputnik V vaccine against coronavirus launched in Kazakhstan
Press release, 21.12.2020

Belarus becomes the first foreign country to register the Sputnik V vaccine
Press release, 21.12.2020

 

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CHINA

National Medical Products Administration [to 26 Dec 2020]
http://english.nmpa.gov.cn/news.html
News
News
Official: Vaccines good for at least 6 months
2020-12-24
The COVID-19 vaccine’s protection can last for more than half a year at least, said Zeng Yixin, deputy head of the National Health Commission, at news conference in Beijing on Dec 19.
He said the estimate is based on follow-up visits to No 3 People’s Hospital of Shenzhen, Guangdong province.
Six months after their recovery, 96 percent of people who had been infected with the novel coronavirus still had antibodies to protect them against new infections, the hospital said.
The follow-ups involved 506 people who had recovered from the infection between January and May.
The longest duration of for positive antibodies in this group was more than 10 months, the hospital said.
The purpose of the follow-up visits was to get an idea of how long the COVID-19 vaccines would provide protection, and to offer reference points in large-scale inoculation plans.
Zeng said there is no doubt that the protection the vaccines can provide is longer than half a year, as stipulated by the World Health Organization.
Even so, he said, it is still too early to say that the vaccines can realize lifetime protection, or provide five to 10 years’ protection.
Follow-up visits to the hospital will last for five years.

Official affirms safety of Chinese vaccines
Respecting laws of science fundamental principle in its development, he says
2020-12-22
Experimental COVID-19 vaccines developed by Chinese researchers are safe, and ongoing efforts to push for their market approval will strictly follow the rules of science, a health official said on Dec 21.
China is conducting third-stage clinical trials for five Chinese-made vaccine candidates overseas and has administered emergency inoculations to nearly 1 million people in the country, according to Zheng Zhongwei, an official with the National Health Commission who is leading the task force on vaccine development.
“These vaccinations have fully demonstrated the safety of Chinese-made vaccines. There is some adverse reaction, but no severe adverse effect has been reported,” he said during a news conference on Monday.
He added that results from third-stage human trials are needed to determine the efficacy of these vaccines, although data from earlier phases of clinical trials and reports from recipients of emergency inoculations in high-risk countries have already shown the protective effects of these doses.
“Some leading developers have just obtained enough cases to conduct analysis of its efficacy. They have begun to submit materials needed for approval to the National Medical Products Administration,” Zheng said.
Market approval will only be granted after submitted trial findings meet the requirements of the top drug regulator, he added.
Zheng stressed that throughout the vaccine development process in China, respecting the laws of science has always been the fundamental principle…

China starts building COVID-19 vaccine production facility
2020-12-22
China started the construction of a plant for manufacturing an mRNA-based COVID-19 vaccine on Dec 21, with production operations due to begin in eight months, according to local authorities.

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

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EMERGENCIES

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

Weekly Epidemiological and Operational updates
Last update: 5 December 2020, 9:02 am GMT-5
Confirmed cases :: 78 604 532 [week ago: 74 299 042] [two weeks ago: 69 808 588]
Confirmed deaths :: 1 744 235 [week ago: 1 669 982] [two weeks ago: 1 588 854]
Countries, areas or territories with cases :: 222

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22 December 2020
Weekly epidemiological update – 22 December 2020
Overview
Globally in the past week, new COVID-19 cases and deaths continued to increase to approximately 4.6 million new cases and over 79 000 new deaths. This brings the cumulative numbers to over 75 million reported cases and 1.6 million deaths globally since the start of the pandemic.

21 December 2020
WHO – Weekly operational update on COVID-19 – 21 December 2020
[Excerpt]
Partnerships
The Global Health Cluster -GHC
The Global Health Cluster released three new GHC COVID-19TaskTeam tools and guidance to support COVID-19 response operations in humanitarian settings:
:: Ethics: key questions to ask when facing dilemmas during COVID-19 in humanitarian settings
:: Essential Health Services: A guidance note How to prioritize and plan essential health services during COVID-19 response in humanitarian settings
:: Health workforce estimator tool to estimate workforce as relevant in humanitarian settings

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

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Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 23 December 2020
:: The19th report of the Independent Monitoring Board (IMB) has been published. The IMB notes the strong resumption of polio campaigns following the temporary pause due to COVID-19 and commends the programme for supporting COVID-19 response efforts. The IMB points to several pivotal challenges which the programme must tackle with urgency to achieve success and offers a set of 17 key recommendations to capitalise on the momentum of resumed immunizations.

:: The GPEI has published a global cVDPV resource document aimed at providing a high-level overview of cVDPVs, their importance to the programme and strategy for responding to them, including nOPV2. Available here in various languages, this resource can be used at global, regional and country levels, for high-level advocacy with government counterparts, internal staff, donors or other partners, as appropriate.

:: On a wintery November day, vaccinators across Afghanistan wrapped up warm, checked that they had facemasks and hand sanitizer, and headed out into the cold morning. Their mission? To reach 9.9 million children with polio vaccines, before snowfall blocked their way. Read more

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
:: Afghanistan: two WPV1 and 23 cVDPV2 positive environmental samples
:: Pakistan: one WPV1 and 11 cVDPV2 cases
:: Benin: one cVDPV2 positive environmental sample
:: Burkina Faso: six cVDPV2 cases
:: Chad: two cVDPV2 cases
:: South Sudan: 10 cVDPV2 cases and one cVDPV2 positive environmental sample

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The World is Waiting :: 19TH REPORT – INDEPENDENT MONITORING BOARD – GLOBAL POLIO ERADICATION INITIATIVE
December 2020 :: 78 pages
Conclusions [excerpt]
The Polio Programme is at a pivotal moment in its history. The weaknesses and failures that led it backwards, over a period of two years, from a place that felt close to the global interruption of poliovirus transmission, to the current epidemiological debacle, are still present.

The Global Polio Programme: a failure of adaptation
The Global Polio Eradication Initiative was launched in 1988, with the passion, energy and fundraising tenacity of Rotary International behind it, together with fellow founding partners (WHO, UNICEF, CDC);
it has been hugely successful for most of its lifetime. Other generous donors (major governments, the Bill & Melinda Gates Foundation, Gavi) have become key partners in the endeavour.

This partnership, its organisational structure, its operating procedures, and its impressive infrastructure on the ground, has driven polio almost to extinction.

That this polio eradication endeavour has faltered over recent years should not come as a surprise. It has been tightly controlled and managed by a global entity, the GPEI. It stands or falls by how this global organisation operates. The GPEI is now 32 years old.

Outside the world of health, and well before 32 years are reached, there are many examples of successful businesses and corporations that have run into serious difficulties, and not just because of their longevity. Crucially, it is because their organisational structure, culture, and business model has not adapted to a changing external environment. Perhaps, also, they have looked back at past glories
and not accepted the need to change because they are “too good to fail.”

The GPEI seems to have reached a similar point in its history.

For some time, it has been clear that the world in which the Polio Programme is embedded has changed around it.

The humble drops of oral polio vaccine are given against a constantly fluctuating geopolitical backdrop. Political unanimity on the importance of polio is much more difficult to secure than it was 32 years ago.

The oral polio vaccine has greater value than its disease preventive potency: as a powerful bargaining tool for factional interests wanting something from their governments.

Some communities have become so hostile to the Polio Programme, and so opposed to letting their children have the vaccine, that negative attitudes may have reached the point of no return. Violence, territorial blockades, murders and intimidation, in some geographies, are directed against polio eradication activity, in marked contrast to most other humanitarian programmes.

Countries have received steady streams of external funding and extensive global involvement and facilitation. This has not always encouraged them to take absolute responsibility and regard polio as their country’s problem.

Finding solutions to these fundamental and deep-rooted barriers to eradication is what is now necessary in order to finish the job. This means the Polio Programme doing things very differently from how it made its name.

Its success came from operating as a technical, disease control programme and this took it a long way. It became overmedicalized in the way that it approached the tasks of eradication. It was not skilled in the tasks of modern management, such as: inspiring people; gathering soft intelligence; managing performance; quality improvement; and daily use of data to devise insightful metrics. In particular, social data were greatly undervalued compared to epidemiological data.

Until late in the day, there was no real belief in alternative delivery models, such as integration. There were regular and unsuccessful vertical programme dashes to try to reach the finishing tape.

These are all reasons why the GPEI – from global to regional to national to local level – needs to adapt and do things differently.

At last, the GPEI has started to talk about this. A six-month long strategy formulation process has been facilitated by external consultants with wide stakeholder involvement. It is set to produce “headlines”
in December 2020.

It is essential that this strategy goes beyond problem diagnosis and pointing out what needs to be done. The problems are already well-established and the steps that need to be taken are very clear.

The GPEI, at the request of polio donor countries, carried out and published a governance review. That has not yet been implemented.

There is a great deal of conversation at the moment, within the GPEI leadership and among the donors and wider polio partners, about these matters. It is using up much emotional energy. Some are saying that these reviews and discussions are not on the critical path to eradication.

The revision of the governance of the GPEI, the revision of the strategy of the GPEI, and the revision of the structure of the GPEI are well overdue.

It is important that there is a new, much more effective, and fully accountable GPEI.

Meanwhile, the task of helping the GPEI to move quickly to face, head-on, the task of finding and implementing definitive, transformational and sustainable solutions to its most intractable barriers to
eradication rests with the GPEI leadership and the leaders of the national polio programmes…

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WHO Grade 3 Emergencies [to 26 Dec 2020]

Democratic Republic of the Congo – No new digest announcements identified
Mozambique floods – No new digest announcements identified
Nigeria – No new digest announcements identified
Somalia – No new digest announcements identified
South Sudan – No new digest announcements identified
Syrian Arab Republic – No new digest announcements identified
Yemen – No new digest announcements identified

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WHO Grade 2 Emergencies [to 26 Dec 2020]
Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burkina Faso – No new digest announcements identified
Burundi – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Ethiopia – No new digest announcements identified
Iran floods 2019 – No new digest announcements identified
Iraq – No new digest announcements identified
Libya – No new digest announcements identified
Malawi Floods – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Mozambique – No new digest announcements identified
Myanmar – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

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WHO Grade 1 Emergencies [to 26 Dec 2020]

Chad – No new digest announcements identified
Djibouti – No new digest announcements identified
Kenya – No new digest announcements identified
Mali – No new digest announcements identified
Namibia – viral hepatitis – No new digest announcements identified
Tanzania – No new digest announcements identified

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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: Syrian Arab Republic: COVID-19 Humanitarian Update No. 22 As of 23 December 2020
:: Recent Developments in Northwest Syria – Situation Report No. 23 – As of 21 December 2020

Yemen – No new digest announcements identified

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UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
COVID-19
:: Coronavirus Disease (COVID-19): Weekly Epidemiological Update (22 December 2020)

East Africa Locust Infestation – No new digest announcements identified

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WHO & Regional Offices [to 26 Dec 2020]

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WHO & Regional Offices [to 26 Dec 2020]
22 December 2020 Departmental news
Joint statement calling for urgent country scale-up of access to optimal HIV treatment for infants and children living with HIV

21 December 2020 Departmental news
Mobilizing youth to End TB

21 December 2020 Departmental news
Behavioural considerations for acceptance and uptake of COVID-19 vaccines

 

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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
:: 24 December 2020 News release
COVID-19 reignites drive for a “One Health” approach to tackle preventable illnesses at the animal-human-ecosystems interface

WHO European Region EURO
:: WHO supports European countries’ response to new virus variant 22-12-2020
:: WHO/Europe’s year in review 2020 22-12-2020
:: Leaving no one behind: access to rehabilitation services is an integral part of universal health coverage 22-12-2020
:: Year-end message by Her Royal Highness The Crown Princess of Denmark, Patron of the WHO Regional Office for Europe 22-12-2020
:: WHO promotes distance care for diabetic patients in Czechia during COVID-19 21-12-2020

WHO Eastern Mediterranean Region EMRO::
:: Heroic health workers losing the battle against COVID-19 23 December 2020
:: Somalia celebrates UHC Day 20 December 2020

WHO Western Pacific Region
No new digest content identified

CDC/ACIP [to 26 Dec 2020]

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CDC/ACIP [to 26 Dec 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
CDC to Require Negative COVID-19 Test for Air Travelers from the United Kingdom to the U.S.
Thursday, December 24, 2020

Media Statement from CDC Director Robert R. Redfield on Vaccine Milestone
Wednesday, December 23, 2020
The United States achieved an early but important milestone today – jurisdictions have now reported that more than 1 million people have received their first dose of COVID-19 vaccine since administration began 10 days ago…