Emerging mental health challenges, strategies, and opportunities in the context of the COVID-19 pandemic: Perspectives from South American decision-makers

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
https://www.paho.org/journal/en

20 Nov 2020
Emerging mental health challenges, strategies, and opportunities in the context of the COVID-19 pandemic: Perspectives from South American decision-makers
Current topic | English |

Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project)

Systematic Reviews
https://systematicreviewsjournal.biomedcentral.com/articles
[Accessed 21 Nov 2020]

 

https://stm.sciencemag.org/
Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) which has rapidly spread worldwide. Several human randomized clinical trials assessing potential vaccines…
Authors: Steven Kwasi Korang, Sophie Juul, Emil Eik Nielsen, Joshua Feinberg, Faiza Siddiqui, Giok Ong, Sarah Klingenberg, Areti Angeliki Veroniki, Fanlong Bu, Lehana Thabane, Allan Randrup Thomsen, Janus C. Jakobsen and Christian Gluud
Citation: Systematic Reviews 2020 9:262
Content type: Protocol
Published on: 20 November 2020

A clinical perspective of the U.S. anti-vaccination epidemic: Considering marginal costs and benefits, CDC best practices guidelines, free riders, and herd immunity

Vaccine
Volume 38, Issue 50 Pages 7877-8054 (25 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/50

 

Discussion Abstract only
A clinical perspective of the U.S. anti-vaccination epidemic: Considering marginal costs and benefits, CDC best practices guidelines, free riders, and herd immunity
Michael G. Anderson, Eric A. Ballinger, David Benjamin, Lawrence D. Frenkel, … Karin W. Zucker
Pages 7877-7879

Cost-effectiveness of HPV vaccination for adults through age 45 years in the United States: Estimates from a simplified transmission model

Vaccine
Volume 38, Issue 50 Pages 7877-8054 (25 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/50

 

Research article Abstract only
Cost-effectiveness of HPV vaccination for adults through age 45 years in the United States: Estimates from a simplified transmission model
Harrell W. Chesson, Elissa Meites, Donatus U. Ekwueme, Mona Saraiya, Lauri E. Markowitz
Pages 8032-8039

Does education about local vaccination rates and the importance of herd immunity change US parents’ concern about measles?

Vaccine
Volume 38, Issue 50 Pages 7877-8054 (25 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/50

 

Research article Open access
Does education about local vaccination rates and the importance of herd immunity change US parents’ concern about measles?
Bridget C. Griffith, Angela K. Ulrich, Andy B. Becker, Dawn Nederhoff, … Nicole E. Basta
Pages 8040-8048

Effect of a vaccine information statement (VIS) on immunization status and parental knowledge, attitudes, and beliefs regarding infant immunization in Japan

Vaccine
Volume 38, Issue 50 Pages 7877-8054 (25 November 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/50

 

Japanese Society for Vaccinology paper
Research article Abstract only
Effect of a vaccine information statement (VIS) on immunization status and parental knowledge, attitudes, and beliefs regarding infant immunization in Japan
Aya Saitoh, Akihiko Saitoh, Tomohiro Katsuta, Mahito Mine, … Kenji Okada
Pages 8049-8054

Vaccination Attitude and Communication in Early Settings: An Exploratory Study

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 21 Nov 2020)

 

Open Access Article
Vaccination Attitude and Communication in Early Settings: An Exploratory Study
by Noemi Mereu et al
Vaccines 2020, 8(4), 701; https://doi.org/10.3390/vaccines8040701 – 20 Nov 2020
Abstract
Background: This study assesses attitudes towards vaccination in mothers of new-born babies and explores its association with different exposures to communication. Methods: Data were collected through questionnaires administered by means of interviews. Results: Data highlighted that 20% of mothers showed an orientation towards […

Strategies to Improve Coverage of Typhoid Conjugate Vaccine (TCV) Immunization Campaign in Karachi, Pakistan

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 21 Nov 2020)

 

Open Access Article
Strategies to Improve Coverage of Typhoid Conjugate Vaccine (TCV) Immunization Campaign in Karachi, Pakistan
by Farah Naz Qamalar et al
Vaccines 2020, 8(4), 697; https://doi.org/10.3390/vaccines8040697 – 19 Nov 2020
Abstract
The emergence and spread of extensively drug-resistant (XDR) typhoid in Karachi, Pakistan led to an outbreak response in Lyari Town, Karachi utilizing a mass immunization campaign with typhoid conjugate vaccine (TCV), Typbar TCV®. The mass immunization campaign, targeted Lyari Town, Karachi, one of […]

Open Access Article
Understanding How Adolescents Think about the HPV Vaccine
by Robyn A. Pennella et al
Vaccines 2020, 8(4), 693; https://doi.org/10.3390/vaccines8040693 – 18 Nov 2020
Abstract
Despite educational efforts, Tennessee human papillomavirus (HPV) vaccination rates are 43%, among the lowest in the United States. This study examined how adolescents think about the HPV vaccine to identify patterns and misconceptions to enhance educational efforts. Adolescents (ages 11–12) (N = […]

Parental Vaccine Preferences for Their Children in China: A Discrete Choice Experiment

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 21 Nov 2020)

 

Open Access Article
Parental Vaccine Preferences for Their Children in China: A Discrete Choice Experiment
by Tiantian Gong et al
Vaccines 2020, 8(4), 687; https://doi.org/10.3390/vaccines8040687 – 16 Nov 2020
Viewed by 276
Abstract
Background: Vaccination is one of the most cost-effective health investments to prevent and control communicable diseases. Improving the vaccination rate of children is important for all nations, and for China in particular since the advent of the two-child policy. This study aims to […]

Media/Policy Watch

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 21 Nov 2020
[No new, unique, relevant content]

 

BBC
http://www.bbc.co.uk/
Accessed 21 Nov 2020
[No new, unique, relevant content]

 

The Economist
http://www.economist.com/
Accessed 21 Nov 2020
[No new, unique, relevant content]

 

Financial Times
https://www.ft.com/
Accessed 21 Nov 2020
Hungary
Brussels warns Hungary on Russian Covid jab
Brussels has warned that Hungary would risk undermining public confidence in coronavirus vaccinations should it bypass the EU medicines regulator and roll out the Russian jab Budapest plans to trial. The European Commission said on Thursday mass Covid-19 inoculation would become “much harder” if citizens began to question a vaccine because it had not been approved as safe and effective. The comments highlight tensions over Budapest’s decision to run clinical trials next month of the Russian Sputnik V drug, which has not yet been assessed by the European Medicines Agency. While the Brussels statement did not mention Hungary or Sputnik V by name, no other EU member state has announced plans for such a radical move outside the bloc-wide vaccination programme overseen by the commission….
November 19, 2020

 

Forbes
http://www.forbes.com/
Accessed 21 Nov 2020
[No new, unique, relevant content]

 

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 21 Nov 2020
[No new, unique, relevant content]

 

Foreign Policy
http://foreignpolicy.com/
Accessed 21 Nov 2020[No new, unique, relevant content]

 

The Guardian
http://www.guardiannews.com/
Accessed 21 Nov 2020
[No new, unique, relevant content]

 

New Yorker
http://www.newyorker.com/
Accessed 21 Nov 2020
[No new, unique, relevant content]

 

New York Times
http://www.nytimes.com/
Accessed 21 Nov 2020
Health
F.D.A. Grants Emergency Authorization of Antibody Treatment Given to Trump
The treatment, made by the biotech company Regeneron, is a cocktail of two powerful antibodies that have shown promise for people who get it early in the course of the disease.
By Katie Thomas and Noah Weiland
Nov 21

 

Washington Post
https://www.washingtonpost.com/
Middle East
Group of 20 leaders call for global coronavirus vaccine access as U.S. labs near approval
By Miriam Berger
November 21, 2020 at 6:12 p.m. EST
BEIRUT — Leaders from the Group of 20 nations urged greater global cooperation Saturday to ensure coronavirus vaccines reach beyond the wealthiest regions as promising U.S. vaccines appear closer to approval.
The comments draw clear contrasts with the Trump administration’s go-it-alone approach, including its break with the World Health Organization. The appeals also struck at questions over whether U.S.-made vaccines would become widely available beyond commercial deals once President-elect Joe Biden takes office — even as the United States struggles with the world’s highest death toll from the coronavirus.
With leaders connecting by video link — and Saudi Arabia as the host — attention quickly turned to vaccines as promising results from U.S.-based labs Pfizer and Moderna raise hopes of additional weapons soon against the pandemic, with China and Russia planning expansion beyond trials of their vaccines…

Think Tanks et al

Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 21 Nov 2020
[No new relevant content]
 
 
Center for Global Development [to 21 Nov 2020]
http://www.cgdev.org/page/press-center
November 18, 2020
A Platform to Support the Researchers and Decision-makers Generating and Using Health Economics Research to Tackle COVID-19
Since the beginning of the outbreak, the scientific community has worked around the clock to produce evidence to support decision-makers in all aspects of COVID management. However, health economics research has been largely missing from this growing literature. The C19economics.org platform has been launched to support policymakers (and their advisers) and researchers working on health economics for COVID, with a focus on LMICs.
Y-Ling Chi et al.
 
 
Chatham House [to 21 Nov 2020]
https://www.chathamhouse.org/
Event
Members Event The Virus, the Vaccine and Violence
23 November 2020 — 4:00PM TO 5:15PM
This webinar assesses the potential for conflict-sensitive approaches to COVID-19 with a focus on vaccines.

 
 
CSIS
https://www.csis.org/
Accessed 21 Nov 2020
[No new relevant content]

 

Council on Foreign Relations
http://www.cfr.org/
Accessed 21 Nov 2020
[No new relevant content]

 

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 21 Nov 2020
November 18, 2020 News Release
What Do State Plans Reveal About Their Readiness to Distribute COVID-19 Vaccines? 
With hopes that a COVID-19 vaccine or vaccines will be proven safe and effective soon, state and local public health authorities will play a critical role in ensuring the efficient distribution and administration of the vaccine. To assess the readiness of these local governments to take on these responsibilities, KFF…

Vaccines and Global Health: The Week in Review :: 14 November 2020

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

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

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

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

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

Over US$ 2 billion raised to support equitable access to COVID vaccines with additional US$ 5 billion needed in 2021

Milestones :: Perspectives :: Research

Over US$ 2 billion raised to support equitable access to COVID vaccines with additional US$ 5 billion needed in 2021 – Gavi
13 November 2020
:: The European Commission, France, Spain, The Republic of Korea and the Bill & Melinda Gates Foundation pledge US$ 360 million to Gavi’s COVID-19 Vaccines Advance Market Commitment (COVAX AMC)
:: Latest announcements mean over US$ 2 billion has been raised towards the effort to ensure equitable access to COVID-19 vaccines for low- and middle-income economies, with at least US$ 5 billion more needed in 2021
:: The Bill & Melinda Gates Foundation has also pledged an additional US$ 20 million to the Coalition for Epidemic Preparedness Innovations (CEPI) to support COVID-19 vaccine research and development

Geneva, 13 November 2020 – Gavi, the Vaccine Alliance welcomes latest pledges in support of the Gavi COVAX AMC, a financing mechanism that will support 92 low- and middle-income economies’ access to safe and effective COVID-19 vaccines. The approximately US$360 million in commitments include US$350m announced at the Paris Peace Forum by the European Commission, France, Spain and The Bill & Melinda Gates Foundation, as well as an earlier pledge of US$10 million made by the Republic of Korea. This means that over US$ 2 billion has been raised for the Gavi COVAX AMC so far, thanks to contributions from other sovereign donors, the private sector, and philanthropic sources. This funding will allow COVAX AMC to reserve and access 1 billion doses for AMC-eligible economies, with at least US$ 5 billion needed in 2021 to procure doses as they come through the portfolio.

The announcements come as 94 higher-income economies have officially joined the COVAX Facility, a global effort to ensure rapid and equitable access to safe and effective COVID-19 vaccines for the most vulnerable groups across the world. These 94 self-financing participants in the COVAX Facility will join the 92 low- and middle-income economies eligible to have their participation in the Facility supported by the Gavi COVAX AMC.

“We are incredibly grateful for the support received so far. This vital funding not only helps us ensure lower-income economies aren’t left at the back of the queue when safe and effective COVID-19 vaccines become available, it will also play a vital role in ending the acute phase of this pandemic worldwide,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “However, this is not the time to take our foot off the gas. We urgently need to raise at least an additional US$ 5 billion by the end of 2021 to ensure equitable distribution of these vaccines to those who need them.”

The details of the latest Gavi COVAX pledges received are as follows:
:: The President of the European Commission pledged EUR 100 million (approximately US$ 120 million) with the aim to support access to vaccines in lower income countries. This amount is in addition to the EUR 400 million (approximately US$ 480 million) in guarantees approved by the European Investment Bank (EIB) on Wednesday. These commitments contribute to Team Europe, a joint effort between the Commission, EIB, the EU’s 27 Member States, Norway and Iceland.

:: France confirmed that the EUR 100m (approximately US$ 120 million) pledged at the Global Vaccine Summit on June 4, as special funds for Gavi to combat COVID-19, will go towards the Gavi COVAX AMC.

:: Spain confirmed that EUR 50 million (approximately US$ 60 million) pledged at the Global Vaccine Summit on June 4, as special funds for Gavi to combat COVID-19, will go towards the Gavi COVAX AMC.

:: The Bill & Melinda Gates Foundation pledged US$ 50 million to the Gavi COVAX AMC. This amount is in addition to US$ 106 million pledged by the Foundation for the COVAX AMC, bringing their total contribution to US$ 156 million.

:: The Republic of Korea has earlier pledged US$ 10 million of new funding to the Gavi COVAX AMC.

The Bill & Melinda Gates Foundation also pledged an additional US$ 20 million to CEPI, which is leading COVAX vaccine research and development work to develop safe and effective vaccines which can be made available to countries participating in the COVAX Facility. Nine candidate vaccines are currently being supported by CEPI; eight of which are currently in clinical trials. Governments, vaccine manufacturers (in addition to their own R&D), organisations and individuals have committed US$ 1.3 billion towards vaccine R&D so far, but an additional US$800m is urgently needed to continue to move the portfolio forward.

The COVAX Facility is part of COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, which is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance, and the World Health Organization (WHO) – working in partnership with developed and developing country vaccine manufacturers, UNICEF, the World Bank, civil society organisations and others. COVAX is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to economies of all financial means.

Worldwide Measles Deaths Climb 50% from 2016 to 2019 Claiming Over 207,500 Lives in 2019

Milestones :: Perspectives :: Research

 

Measles

Worldwide Measles Deaths Climb 50% from 2016 to 2019 Claiming Over 207,500 Lives in 2019
NEW YORK/ GENEVA/ ATLANTA, 12 November 2020 – Measles surged worldwide in 2019 reaching highest number of reported cases in 23 years.  Highlighted in a publication by the World Health Organization (WHO) and the United States Centers for Disease Control and Prevention (CDC), measles cases worldwide increased to 869,770 in 2019, the highest number reported since 1996 with increases in all WHO regions. Global measles deaths climbed nearly 50 percent since 2016, claiming an estimated 207,500 lives in 2019 alone.

After steady global progress from 2010 to 2016, the number of reported measles cases climbed progressively to 2019. Comparing 2019 data with the historic low in reported measles cases in 2016, authors cite a failure to vaccinate children on time with two doses of measles-containing vaccines (MCV1 and MCV2) as the main driver of these increases in cases and deaths.

“We know how to prevent measles outbreaks and deaths,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “These data send a clear message that we are failing to protect children from measles in every region of the world.  We must collectively work to support countries and engage communities to reach everyone, everywhere with measles vaccine and stop this deadly virus.”…

 

Global response to COVID-19 pandemic must not exacerbate the measles crisis
Although reported cases of measles are lower in 2020, necessary efforts to control COVID-19 have resulted in disruptions in vaccination and crippled efforts to prevent and minimize measles outbreaks. As of November, more than 94 million people were at risk of missing vaccines due to paused measles campaigns in 26 countries.  Many of these countries are experiencing ongoing outbreaks.  Of countries with postponed planned 2020 campaigns, only eight (Brazil, Central African Republic, Democratic Republic of Congo, Ethiopia, Nepal, Nigeria, Philippines and Somalia) resumed their campaigns after initial delays.

“Before there was a coronavirus crisis, the world was grappling with a measles crisis, and it has not gone away,” said Henrietta Fore, UNICEF Executive Director. “While health systems are strained by the COVID-19 pandemic, we must not allow our fight against one deadly disease to come at the expense of our fight against another. This means ensuring we have the resources to continue immunization campaigns for all vaccine-preventable diseases, even as we address the growing COVID-19 pandemic.”

 

Causes of failure to control measles are many and must be addressed
Global immunization partners are engaging leaders and public health professionals in affected and at-risk countries to ensure that measles vaccines are available and safely delivered, and that caregivers understand the life-saving benefit of the vaccine.  On 6 November 2020, WHO and UNICEF issued an emergency call to action for measles and polio outbreak prevention and response

First ever vaccine listed under WHO emergency use

Milestones :: Perspectives :: Research

 

nOPV2

First ever vaccine listed under WHO emergency use
13 November 2020
WHO today listed the nOPV2 vaccine (Bio Farma, Indonesia) for emergency use to address the rising cases of a vaccine-derived polio strain in a number of African and East Mediterranean countries. Countries in WHO’s Western Pacific and South-East Asia regions are also affected by these outbreaks. The emergency use listing, or EUL, is the first of its kind for a vaccine and paves the way for potential listing of COVID-19 vaccines.

The world has made incredible progress toward polio eradication, reducing polio cases by 99.9% in the last 30 years. But the last steps to ending this disease are proving the most difficult, particularly with continuing outbreaks of circulating vaccine-derived polio viruses (cVDPVs)…

 

The EUL procedure and how it could help to speed up access to a future COVID-19 vaccine
The EUL procedure assesses the suitability of yet to be licensed health products during public health emergencies, such as polio and COVID. The objective is to make these medicines, vaccines and diagnostics available faster to address the emergency. The assessment essentially weighs the threat posed by the emergency against the benefit that would accrue from the use of the product based on a robust body of evidence.

The procedure was introduced during the West Africa Ebola outbreak of 2014-2016, when multiple Ebola diagnostics received emergency use listing; since then, numerous COVID-19 diagnostics have also been listed. The nOPV2 is the first such listing for a vaccine.

The EUL pathway involves a rigorous assessment of phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy and manufacturing quality. These data are reviewed by independent experts who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and the plans for further studies.

Experts from individual national authorities are invited to participate in the EUL review and are engaged to help facilitate the necessary country-level decision process for authorization of use. Once a vaccine has been listed for WHO emergency use, WHO engages its regional regulatory networks and partners to sensitize national health authorities on the vaccine and its anticipated benefits based on data from clinical studies to date.

In addition to deciding whether to use the vaccine, each country needs to complete a readiness process for the implementation of the vaccine under the EUL. The company producing the vaccine also commits to continue to generate data to enable full licensure and WHO prequalification of the vaccine. WHO prequalification will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine continues to meet the necessary standards of quality, safety and efficacy for broader availability (i.e. through procurement by UN agencies and others).

COVID-19 Vaccines – Development/Distribution

Milestones :: Perspectives :: Research

 

COVID-19 Vaccines – Development/Distribution

Johnson & Johnson and U.S. Department of Health & Human Services Expand Agreement to Support Next Phase of COVID-19 Vaccine Candidate Research and Development
NEW BRUNSWICK, N.J., Nov. 14, 2020 /PRNewswire/ — Johnson & Johnson (the Company) announced the expansion to the partnership between its Janssen Pharmaceutical Companies (Janssen) and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services for the ongoing development of Janssen’s investigational COVID-19 vaccine candidate.
Under the amendment, Janssen will commit approximately $604 million and BARDA will commit approximately $454 million to support the ongoing Phase 3 ENSEMBLE trial evaluating Janssen’s investigational COVID-19 vaccine candidate as a single-dose in up to 60,000 volunteers worldwide…

 

::::::

Moderna Has Completed Case Accrual for First Planned Interim Analysis of its mRNA Vaccine Against COVID-19 (mRNA-1273)
Acceleration in rate of COVID-19 disease across trial sites; Company expects more than 53 cases will be submitted to Data Safety Monitoring Board for the first interim analysis
November 11, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that it has completed case accrual for the first interim analysis of the Phase 3 COVE study of mRNA-1273, its COVID-19 vaccine candidate.
Moderna has seen a significant increase in the rate of case identification across sites in the last week. As a result, the Company expects the first interim analysis will include substantially more than 53 cases, the targeted trigger point for the analysis. The data on these cases is being prepared for submission to the independent Data Safety Monitoring Board (DSMB) for analysis and recommendation. Moderna remains blinded to whether these participants received vaccine or placebo…

 

::::::

The First Interim Data Analysis of the Sputnik V Vaccine Against COVID-19 Phase III Clinical Trials in the Russian Federation Demonstrated 92% Efficacy
November 11, 2020
:: The Sputnik V vaccine efficacy amounted to 92% (calculation based on the 20 confirmed COVID-19 cases split between vaccinated individuals and those who received the placebo). Currently 40,000 volunteers are taking part in double-blind, randomized, placebo-controlled Phase III of Sputnik V clinical trials, out of which over 20,000 have been vaccinated with the first dose of the vaccine and more than 16,000 with both the first and second doses of the vaccine.
:: Efficacy was demonstrated on the basis of a first interim analysis obtained 21 days after the first injection.
:: There were no unexpected adverse events during the trials. Monitoring of the participants is ongoing.
:: The world’s first registration of COVID-19 vaccine, done in Russia on the 11th of August under the emergency use authorization mechanism, enables the Russian Federation to administer the vaccine outside of the clinical trials to volunteers such as medics and other high-risk groups. Trials conducted under the civil use of the vaccine in Russia (not being a part of clinical trials) based on the monitoring of additional 10,000 vaccinated confirmed vaccine efficacy at a rate of over 90%.
:: The interim research data will be published by the Gamaleya Center team in one of the leading international peer-reviewed medical journals. Following the completion of Phase III clinical trials of the Sputnik V vaccine, Gamaleya Center will provide access to the full clinical trial report.
:: Currently Sputnik V Phase III clinical trials are approved and are undergoing in Belarus, UAE, Venezuela and other countries, as well as Phase II-III – in India.
:: The Sputnik V vaccine is based on a well-studied human adenoviral vector platform that had proven safe and effective with no long-term side effects in more than 250 clinical trials globally conducted during the past two decades (while the history of use of human adenoviruses in vaccine development started in 1953). More than 100,000 people have received approved and registered drugs based on the human adenoviral vectors.
:: The uniqueness of the Russian vaccine is in using two different human adenoviral vectors that enable to provide strong and long-term immune response after the second injection.

 

::::::

Pfizer and BioNTech Reach an Agreement to Supply the EU With 200 Million Doses of Their BNT162b2 mRNA-Based Vaccine Candidate Against SARS-CoV-2
November 11, 2020
:: Agreement provides a supply of 200 million doses and an option to request additional 100 million doses, with deliveries anticipated to start by the end of 2020, subject to regulatory approval
:: The vaccine supply for the EU will be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium and based on current projections, the companies expect to produce globally up to 1.3 billion doses in 2021
:: Pfizer and BioNTech initiated a rolling submission to the European Medicines Agency (EMA) in October, and will continue regular and open dialogue with the EMA providing results from their ongoing Phase 3 study

 

::::::

Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study
November 09, 2020
:: Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
:: Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
:: Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
:: Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints

COVID-19 Vaccines – Procurement

Milestones :: Perspectives :: Research

 

COVID-19 Vaccines – Procurement

UNICEF and PAHO launch joint COVID-19 vaccine tender on behalf of COVAX Facility
NEW YORK/WASHINGTON DC, 12 November 2020: UNICEF and the Pan American Health Organization (PAHO) announced today the launch of a tender inviting all COVID-19 vaccine developers to submit a proposal for supply in 2021.

The tender, which will run for 6 weeks, aims to provide at least 2 billion doses of COVID-19 vaccines on behalf of the COVAX Facility, administered by Gavi, the Vaccine Alliance. The aim of the tender is to ensure equitable and accelerated access to quality assured vaccines for the 186 participating economies as of today.

All manufacturers expecting to have supply available by the end of 2021 at the latest are invited to respond to the tender, including those that have already signed advance purchase commitments with Gavi, as well as those with pre-existing agreements with the Coalition for Epidemic Preparedness Innovations (CEPI) on vaccine development.

Matching the unprecedented challenge of addressing the pandemic requires that an innovative procurement process to secure quality-assured COVID-19 vaccines is designed. This entails pooling demand across 186 participants under the COVAX Facility, against which manufacturers of COVID-19 vaccines can submit bids, with UNICEF and PAHO joining forces through joint tendering. This will help to optimize supply from a wide array of potential manufacturers using different technology platforms, thereby improving the likelihood of accessing successfully licensed products in the shortest possible time while securing the lowest price on the global market.

Of the 186 participating economies, 92 lower-income economies will receive financial support through the Advance Market Commitment (AMC) of the COVAX Facility. These economies include those defined by the World Bank as low- and lower middle-income economies, as well as economies eligible for international development assistance.

Of the countries that are part of the AMC, UNICEF will take the lead on the purchase of the vaccine for 82 participants outside of the Americas, while PAHO, through its Revolving Fund, will purchase the vaccine for 10 of its Member States in the Americas.

Self-financing economies participating in the COVAX Facility will have the option to buy vaccines themselves – or through UNICEF, and PAHO, based on key terms negotiated via the COVAX Facility. PAHO will purchase on behalf of all interested Member States from the Americas; as of today, 28 self-financing economies have signed agreements with the COVAX Facility.

UNICEF and PAHO will establish long-term agreements to facilitate procurement and delivery but will also identify additional vaccine candidates to be targeted for advance purchase commitments by the COVAX Facility. The WHO framework for fair and equitable access to COVID-19 vaccines[1] will provide guidance on the allocation of supply. Manufacturers will be expected to deliver vaccines as per UNICEF and PAHO terms and conditions for lower-income economies.

Working in coordination with leading regulatory authorities, all vaccines will be endorsed for safety, efficacy, and quality by WHO before delivery. UNICEF and PAHO aim to sign supply arrangements with successful manufacturers to support early access to COVID-19

News: EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines

Milestones :: Perspectives :: Research

 

COVID-19 Vaccines – Pharmacovigilance

News & Press Releases
News: EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines
Last updated: 13/11/2020
EMA and the national competent authorities (NCAs) in EU Member States have prepared a  safety monitoring plan for COVID-19 vaccines . The plan outlines how relevant new information emerging after the authorisation and uptake of COVID-19 vaccines in the pandemic situation will be collected and promptly reviewed.

The safety of COVID-19 vaccines will be monitored according to the guidance set out by EMA and NCAs in the good pharmacovigilance practices (GVP), that applies to all medicines. In view of the extraordinary circumstances, though, EU authorities have planned several activities that will apply specifically to COVID-19 vaccines.

Through the implementation of these activities, the EU medicines regulatory network will assess any safety data emerging from a range of different sources (spontaneous reporting, observational studies, etc.). Any potential safety concerns identified will be addressed by taking appropriate regulatory action to safeguard individual and public health and communicating with the public in a transparent and timely manner.

 

The plan comprises new reporting obligations for companies that will have to submit monthly safety reporting summaries in addition to the regular updates foreseen by the legislation. Furthermore, the plan details the scientific studies already in place to monitor the safety, effectiveness and coverage of COVID-19 vaccines after their authorisation. Lastly, it details the exceptional transparency measures set up by EMA as well as how the Agency plans to engage with a wide range of stakeholders.

In this context, EMA has also published guidance to support pharmaceutical companies’ preparation of risk management plans (RMPs) for COVID-19 vaccines . As for any medicine, companies applying for a marketing authorisation for COVID-19 vaccines must submit RMPs. The RMP explains how the company must monitor and report on the safety of the vaccine once authorised, and what measures it must put in place to further characterise and manage risks. RMPs are updated as new information becomes available. The RMP guidance for COVID-19 vaccines complements the existing guidelines on the RMP format in the EU and guidance on good pharmacovigilance practices, which apply to all medicines.

Additional specific considerations in this guidance address, for example:
:: further information on vaccine safety that might be generated after the marketing authorisation in special populations, such as the elderly, children, or patients with co-morbidities;
:: core requirements for lists of adverse events of special interest (AESI), methods used for signal detection, and follow-up of any safety signals identified in clinical trials;
:: submission of monthly summary safety reports by marketing authorisation holders to EMA in addition to the usual periodic safety update reports;
:: traceability tools that can help record who has received which vaccine and from which batch.

All activities that companies include in the RMP for a COVID-19 vaccine should take into account EMA’s infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice…

COVAX-19 Vaccines &Therapeutics – Equity/Access

Milestones :: Perspectives :: Research

 

COVAX-19 Vaccines &Therapeutics – Equity/Access

Innovative and generic & biosimilar pharmaceutical industries unite on commitment to equitable access to COVID-19 medicines and vaccines, while flagging where further help is needed from others
IGBA and IFPMA Published on: 10 November 2020
[Editor’s text bolding]
Geneva 10 November 2020 – On the occasion of the World Health Assembly, the world’s research-based and generic & biosimilar pharmaceutical industry bodies delivered a statement declaring their shared commitment to equitable access to COVID-19 medicines and vaccines. In their joint statement, the two global pharmaceutical industry bodies acknowledge their responsibility and commitment to support the international response to the pandemic with their unique scientific, technical and manufacturing expertise to meet the increased demand for medicines; and to the discovery and development of affordable therapeutics and vaccines for COVID-19.  However, for the pharmaceutical industry to do so fully, it requires others to play their part.

The two pharmaceutical industry bodies list eight areas of shared concern that require international solidarity, cooperation, coordination and support. The areas covered involve trade, disease surveillance and demand forecasting, regulatory alignment, partnership, support for balanced intellectual property; and for multilateral organizations and country leaders to align on allocation principles to ensure fair and equitable access to COVID-19 treatments and vaccines. They also underscore the need to ensure adequate resources are spent to build stronger, more resilient health systems.

From the outset of the coronavirus pandemic, the whole pharmaceutical industry has shown commitment to business integrity and stepped up to bring its expertise to meet the increased demand for medicines; and to the discovery and development of affordable therapeutics and vaccines for COVID-19.  The two global trade federations representing the research-based pharmaceutical industry (IFPMA) and the generic and biosimilar medicines industries (IGBA), are founding partners of the Access to COVID-19 Tools (ACT) Accelerator.  By joining this unique multi-stakeholder partnership, the industry bodies recognised their shared responsibility in bringing their unique scientific, technical and manufacturing expertise to meet the increased demand for medicines.  In the spirit of the principles of international solidarity, the two pharmaceutical bodies call on others to play their part in providing the enabling environment needed for the industry to do its job in the best way possible.

Moving forward, the two industry bodies (IGBA and IFPMA) point to the importance of ensuring adequate resources are spent to build stronger, more resilient health systems that can cope with complex health challenges. It will also be essential to minimise the disruption to the provision of essential health services and continue the fight against priority diseases.  Not to do so will undermine the significant progress we have made together on major health challenges such as non-communicable diseases (NCDs), routine immunisation, and other infectious diseases.

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

EMERGENCIES

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

Weekly Epidemiological and Operational updates
last update: 14 November 2020, 10:30 GMT-4
Confirmed cases :: 53 164 803 [week ago: 49 106 931] [two weeks ago: 45 428 73]
Confirmed deaths :: 1 300 576 [week ago: 1 239 157] [two weeks ago: 1 185 721]
Countries, areas or territories with cases :: 220

::::::

10 November 2020
Weekly epidemiological update – 10 November 2020
Overview
Globally in the past week, cases of COVID-19 have increased by 8%, compared to the previous week, resulting in over 3.6 million new cases, while new deaths have increased by 21% to over 54 000. This brings the cumulative numbers to over 49.7 million reported cases and over 1.2 million deaths globally since the start of the pandemic.

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

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

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 11 November 2020
:: In a year marked by the global COVID-19 pandemic, global health leaders convening virtually at this week’s World Health Assembly called for continued urgent action on polio eradication. The Assembly congratulated the African region on reaching the public health milestone of certification as wild polio free, but highlighted the importance of global solidarity to achieve the goal of global eradication and certification…Read more
:: Last week, WHO and UNICEF launched an emergency call to action for measles and polio outbreak response, to protect children by vaccination. It is a global call to action, both for countries to re-boost their immunization systems in the wake of COVID-19 and for the international community to work together to ensure that the financial resources needed on an emergency basis are rapidly made available.
:: 13 November is the deadline for prospective bidders to submit their applications for the Consultancy to provide technical support to the GACVS (Global Advisory Committee on Vaccine Safety) Sub-Committee for nOPV2. More information on the Request for Proposals.

Summary of new WPV and cVDPV viruses this week (AFP cases and environmental samples):
:: Afghanistan: 15 cVDPV2 cases and 13 cVDPV2 positive environmental samples
:: Pakistan: five WPV1 positive environmental samples and five cVDPV2 positive environmental samples
:: Chad: one cVDPV2 case
:: Somalia: three cVDPV2 cases

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

WHO Grade 3 Emergencies [to 14 Nov 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

::::::

WHO Grade 2 Emergencies [to 14 Nov 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

::::::

WHO Grade 1 Emergencies [to 14 Nov 2020]

Chad – No new digest announcements identified
Djibouti – Page not responding at inquiry
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

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

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 Response Update No. 12 – 9 November 2020
HIGHLIGHTS
. As of 9 November, the Syrian Ministry of Health (MoH) reported 6,215 laboratory-confirmed cases, 317 fatalities, and 2,357 recoveries in Government of Syria (GoS)-controlled areas
. To date, 194 cases amongst healthcare workers (HCWs) in GoS-controlled areas have been reported
. In northwest Syria (NWS), as of 3 November, 7,059 confirmed cases of COVID-19 were reported, including 42 deaths
. In northeast Syria (NES), 4,978 cases were confirmed as of 3 November, including 758 recoveries and 133 deaths
.Areas of concern: Densely populated areas, notably Damascus/Rural Damascus, Aleppo and Homs, and those living in camps and informal settlements in NES, collective shelters throughout the country, as well as other areas, including Deir-Ez-Zor, where hostilities may make ongoing sample collection more challenging

Yemen – No new digest announcements identified

::::::

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.
East Africa Locust Infestation
:: Desert Locust situation update – 12 November 2020

COVID-19 – No new digest announcements identified

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

WHO & Regional Offices [to 14 Nov 2020]

WHO & Regional Offices [to 14 Nov 2020]
13 November 2020 News release
Access to COVID 19 Tools Accelerator commitments reach US$ 5.1billion following new contributions, including at Paris Peace Forum

13 November 2020 Departmental news
First ever vaccine listed under WHO emergency use
[See Milestones above for detail]

13 November 2020 News release
WHO establishes Council on the Economics of Health for All

12 November 2020 News release
WHA73 endorses resolutions on meningitis control and epilepsy, roadmap on neglected tropical diseases

12 November 2020 News release
Worldwide measles deaths climb 50% from 2016 to 2019 claiming over 207 500 lives in 2019

12 November 2020 Departmental news
Neglected tropical diseases: World Health Assembly endorses bold new road map targets for 2030
2030 road map targets
The road map sets global targets and milestone to prevent, control, eliminate and eradicate 20 neglected tropical diseases (NTDs) and disease groups. By shifting away from single-disease vertical programmes to integrated approaches, it aims to promote improved coordination and collaboration. Another distinct feature is to drive greater ownership by national and local governments, including communities. The overarching 2030 global targets are to:
:: reduce by 90% the number of people requiring treatment for NTDs
:: eliminate at least one NTD in 100 countries
: eradicate two diseases (dracunculiasis and yaws)
:: reduce by 75% the disability-adjusted life years (DALYs) related to NTDs
The road map’s cross-cutting and other targets can be consulted here.

12 November 2020 Departmental news
Updated dashboard supports differentiated HIV testing services

12 November 2020 Departmental news
WHO HTS Info app

11 November 2020 Departmental news
2021 designated as the International Year of Health and Care Workers

10 November 2020 News release
73rd World Health Assembly set to strengthen preparedness for health emergencies

9 November 2020 Statement
Statement to the resumed 73rd World Health Assembly by the Chair of the Review Committee on the Functioning of the International Health Regulations (2005) during the COVID-19 Response
[Excerpt]
[7] Preliminary findings include:
:: Preparedness assessment and monitoring as well as core capacities need to be further examined in light of the observed performance in the response of many Member States. A universal peer-review mechanism such as that used in human rights reviews may be useful.
:: Both official information as well as information through media, social media and rumors are useful surveillance information. IHR provisions for notification and verification of information for events need to be further examined to understand the reluctance of some countries for early reporting and the need for incentives or other approaches to ensure better compliance.
:: WHO-provided Rapid Risk Assessments for events that may pose a risk of international spread are of utmost importance.
:: The meaning and consequences of Public Health Emergencies of International Concern have to be fully understood by Member States and inter- as well as supranational institutions. The relevance of an intermediate level of alert to prevent a PHEIC from occurring, and options for its implementation, need to be also clearly examined.
:: Implementation of travel restrictions at the national level was widespread. The role of WHO in relation to travel recommendations as well as incentives for States Parties to comply with their obligations related to travel measures need to be further examined.
:: Strong support for the current mechanisms for global outbreak alert and response as well as adequate national legislation are key to strengthen the response to global public health risks. The authority of National IHR Focal Points is critical to ensure rapid communication and coordination.
:: What also became very clear during our work so far, and looking beyond just the IHR, both strong public health as well as health care systems are needed for effective response.

[8] Beside the work in the sub-groups we have started to organize our work around issues that are not addressed in the sub-groups or are relevant for more than one sub-group. These include:
:: The overarching question of whether the IHR are fit for purpose. Are there challenges in their design or in their implementation that raised concerns during the COVID-19 response?
:: Issues of financing at the national and international level, especially for preparedness, as well as the functions and effectiveness of IHR governance bodies and mechanisms.
:: Conducting an article-by-article analysis to ensure a systematic review and identify whether any amendments may be required.
:: And examining the progress made on implementing the recommendations of previous Review Committees to refine our own recommendations….

9 November 2020 News release
WHO Director-General calls on world to “choose health” at resumed 73rd World Health Assembly in the Year of the Nurse and the Midwife

 

::::::

Call for consultant to support countries to conduct cold chain and Effective Vaccine Management (EVM) assessments as part of COVID-19 vaccine deployment
Department of Immunization, Vaccines and Biologicals (IVB) Essential Programme on Immunization (EPI)
11 November 2020 Call for consultation

 

::::::

Weekly Epidemiological Record, 13 November 2020, vol. 95, 46 (pp. 557–572)
:: Routine vaccination coverage – worldwide, 2019
:: Progress towards regional measles elimination – worldwide, 2000–2019

 

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Nearly 1 in 5 COVID-19 deaths in the African region linked to diabetes 12 November 2020
:: Mauritian clinics help cut diabetic foot amputations 12 November 2020

WHO Region of the Americas PAHO
No new digest content identified

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

WHO European Region EURO
:: Hopeful, colourful, simple: WHO adapts COVID-19 messages in Ukraine to the local audience 13-11-2020
:: Outstanding public health achievements from the WHO European Region receive the highest recognition at the resumed 73rd World Health Assembly 13-11-2020
:: WHO/Europe is focusing on eye screening for people with diabetes 13-11-2020
Antimicrobials: handle with care. United in the One Health approach to protect antimicrobials 12-11-2020
:: Romania and the Republic of Moldova stand together to tackle COVID-19 11-11-2020

WHO Eastern Mediterranean Region EMRO
No new digest content identified

WHO Western Pacific Region
No new digest content identified

CDC/ACIP [to 14 Nov 2020]

CDC/ACIP [to 14 Nov 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
[No new digest content identified]

Coronavirus Disease 2019 (COVID-19)
Selected Resources
:: Use of Masks to Help Slow the Spread of COVID-19 Thursday, November 12, 2020
:: Trump Administration Partners with Chain and Independent Community Pharmacies to Increase Access to Future COVID-19 Vaccinesexternal icon
November 12, 2020
:: Holiday Celebrations Wednesday, November 11, 2020

MMWR News Synopsis Friday, November 13, 2020
:: COVID-19 Outbreak in an Amish Community — Ohio, May 2020
:: Mental Health-Related Emergency Department Visits Among Children Aged <18 years During the COVID-19 Pandemic — United States, January 1, 2020–October 17, 2020
:: Risk Assessment and Management of COVID-19 Among Travelers Arriving at Designated U.S. Airports, January 17–September 13, 2020
:: Multiple COVID-19 Outbreaks Linked to a Wedding Reception in Rural Maine — August 7–September 14, 2020
:: Declines in SARS-CoV-2 Transmission, Hospitalizations, and Mortality After Implementation of Statewide Mitigation Measures— Delaware, March–June 2020 (Early release November 6, 2020)
:: Characteristics of Hospitalized COVID-19 Patients Discharged and Experiencing Same-Hospital Readmission — United States, March–August 2020 (Early release November 9, 2020)
:: Progress Toward Regional Measles Elimination — Worldwide, 2000–2019
:: Routine Vaccination Coverage — Worldwide, 2019

China CDC

China CDC
http://www.chinacdc.cn/en/
No new digest content identified.

 

National Health Commission of the People’s Republic of China
http://en.nhc.gov.cn/
News
Nov 14: Daily briefing on novel coronavirus cases in China
On Nov 13, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 18 new cases of confirmed infections.

China spares no effort in developing COVID-19 vaccine
Updated: 2020-11-13 | Xinhua
BEIJING — China attaches great importance to the safety and effectiveness of COVID-19 vaccines and strictly observes international standards, as well as relevant laws and regulations, according to a Chinese Foreign Ministry spokesperson at a daily press briefing on Nov 12.
Spokesperson Wang Wenbin’s remarks came after Brazil’s health regulator approved the resumption of clinical trials of a Chinese-developed coronavirus vaccine following two days of suspension.
“We are glad to see the Phase III clinical trial of a COVID-19 vaccine resumed in Brazil,” said Wang.
He added that four Chinese vaccine candidates had already launched the Phase III clinical trials in several countries, and all of the vaccines were tentatively safe.
“Many countries have spoken highly of Chinese-made vaccines,” said the spokesperson, adding that Chinese firms have spared no effort in developing COVID-19 vaccines in line with science and regulations.
“China and Brazil have cooperated well in fighting the pandemic, and we believe our cooperation in this regard will contribute to prevailing over COVID-19 for both countries and the world,” said Wang.

Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 14 Nov 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 14 Nov 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

 

BMGF – Gates Foundation [to 14 Nov 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
NOVEMBER 12, 2020
Gates Foundation announces new funds to develop COVID-19 vaccines and increase access to affordable vaccines in low-income countries
Speaking at the Paris Peace Forum today, Melinda Gates will commit an additional $70 million and urge accelerated global action to end pandemic for everyone, everywhere
…Gates will say the foundation will commit an additional $50 million to the COVAX Advance Market Commitment (AMC) of Gavi, the Vaccine Alliance, a financing mechanism through which Gavi aims to secure equitable access to COVID-19 vaccines for 92 low- and middle-income countries. The foundation’s pledge to the AMC will unlock an additional £12.5 million (approximately US $16.2 million) from the UK government, which in September committed to matching other contributions to the AMC.
Gates will also announce a $20 million grant to the Coalition for Epidemic Preparedness Innovations (CEPI) to advance research and jumpstart the development for an additional slate of promising vaccine candidates as the first wave conclude their clinical trials and file for approval. Because they have greater potential for large-scale manufacturability, temperature stability, and low-cost production, this next group of candidate vaccines may be better suited to the needs of low- and middle-income settings and, therefore, able to increase equitable access to affordable vaccines..

 

Bill & Melinda Gates Medical Research Institute [to 14 Nov 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

 

CARB-X [to 14 Nov 2020]
https://carb-x.org/
News
11.10.2020  |
CARB-X is funding Locus Biosciences to develop an innovative CRISPR Cas-3-enhanced bacteriophage targeting antibiotic-resistant Klebsiella pneumoniae infections
CARB-X is awarding up to US$2.05 million to Locus Biosciences to develop a new precision medicine to treat serious recurring urinary tract infections (rUTI) caused by the bacterial pathogen Klebsiella pneumoniae.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 14 Nov 2020]
http://cepi.net/
Latest News
CEPI receives funding for development of ‘next generation’ of COVID-19 vaccine candidates
12 Nov 2020
CEPI will receive a grant of up to $20m from the Bill & Melinda Gates Foundation to expand its portfolio of COVID-19 vaccines to include candidates that are differentiated from those already in advanced development. The world is likely to be living with COVID-19 for many years to come, so the grant will accelerate the development of the next generation of vaccines (‘Wave 2 vaccines’) that could address gaps in the current global vaccine development landscape, helping to ensure vaccines are available in the future that are easier to deliver and address the specific needs of a diverse range of populations and settings…

CEPI welcomes launch of new Plague Inc. game to show the world how to stop the next pandemic
With scientific input from infectious disease experts, including CEPI, Plague Inc: The Cure shows one of the most detailed and interactive representations of a pandemic.
11 Nov 2020

CEPI welcomes announcement from Pfizer / BioNTech of positive interim data from Phase III trial of COVID-19 vaccine candidate
09 Nov 2

 

EDCTP [to 14 Nov 2020]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
11 November 2020
EDCTP and The Global Health Network launch the EDCTP Knowledge Hub
EDCTP and The Global Health Network have launched the EDCTP Knowledge Hub, an online platform with open-access resources for researchers conducting clinical research in low-resource settings. With financial support from the European Union and the Swedish government, EDCTP commissioned The Global Health Network to develop this digital knowledge hub to provide researchers with tools and guidance that enable them to undertake high-quality health research.

 

Emory Vaccine Center [to 14 Nov 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 14 Nov 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines
Last updated: 13/11/2020
[See COVID above for detail]

 

 

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 2020
CHMP, Last updated: 13/11/2020

 

European Vaccine Initiative [to 14 Nov 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 14 Nov 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
November 13, 2020 – Coronavirus (COVID-19) Update: November 13, 2020

November 12, 2020 – Coronavirus (COVID-19) Update: November 12, 2020
:: On November 10, the FDA updated the dashboard on the Coronavirus Treatment Acceleration Program (CTAP) webpage. As of October 31, more than 560 drug development programs were in planning stages, over 370 trials had been reviewed by FDA, 5 COVID-19 treatments were currently authorized for emergency use, and 1 treatment was approved by FDA for use in COVID-19.

November 10, 2020 – Coronavirus (COVID-19) Update: November 10, 2020

November 9, 2020 – Coronavirus (COVID-19) Update: November 9, 2020
:: Today, the FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients…
:: In addition today, the FDA issued final guidance with the agency’s recommendations on designing and executing clinical trials of drugs and biologics that include people with different demographic characteristics (e.g., sex, race, ethnicity, age) and non-demographic characteristics (e.g., patients with organ dysfunction, comorbid conditions, and disabilities.) The final guidance provides the agency’s current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices, trial designs, and methodological approaches, as well as recommendations for how sponsors can increase enrollment of underrepresented populations in their clinical trials…

November 9, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.
While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo…

 

FDA – COVID-19 Vaccines [to 14 Nov 2020]
www.fda.gov/covid19vaccines
Upcoming Events
No new digest content identified.

 

Fondation Merieux [to 14 Nov 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

 

Gavi [to 14 Nov 2020]
https://www.gavi.org/
News releases
13 November 2020
Over US$ 2 billion raised to support equitable access to COVID vaccines with additional US$ 5 billion needed in 2021
[See COVAX above for detail]

 

GHIT Fund [to 14 Nov 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.

 

Global Fund [to 14 Nov 2020]
https://www.theglobalfund.org/en/news/
News
Germany signs EUR150 million contribution to the Global Fund’s COVID-19 response
12 November 2020
The German Federal Ministry of Economic Cooperation and Development and the Global Fund signed an additional contribution agreement of EUR150 million to mitigate the impact of COVID-19 in low- and middle-income countries, signaling a strong partnership in the fight against the pandemic.

News
Global Fund Board signals strong commitment to sustain the fight against HIV, TB, malaria while supporting the global response to COVID-19
12 November 2020
The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria met virtually for the 44th Board meeting this week to discuss the organization’s response to the COVID-19 pandemic, development of the next Global Fund strategy and progress in the fight against HIV, TB and malaria.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 14 Nov 2020]
https://www.glopid-r.org/news/
News
No new digest content identified.

 

Hilleman Laboratories [to 14 Nov 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 14 Nov 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.

 

IAVI [to 14 Nov 2020]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
No new digest content identified.

 

 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
No new digest content identified.

 

 

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
Innovative and generic & biosimilar pharmaceutical industries unite on commitment to equitable access to COVID-19 medicines and vaccines, while flagging where further help is needed from others (November 2020)
Geneva 10 November 2020 – On the occasion of the World Health Assembly, the world’s research-based and generic & biosimilar pharmaceutical industry bodies delivered a statement declaring their shared commitment to equitable access to COVID-19 medicines and vaccines. In their joint statement…
[See COVID above for detail]

 

 

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

 

IFRC [to 14 Nov 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Czechia, Europe, France, Georgia, Italy, Monaco, Netherlands, Slovakia
COVID-19: Red Cross Red Crescent steps up European response, urges Governments to strengthen testing, tracing and isolation measures
IFRC is urging Governments to strengthen their “test-trace-quarantine” systems to help prevent future surges of COVID-19. This call comes as multiple European countries put in place new restrictions to stop community transmission and to avoid the collapse of health systems.
11 November 2020

 

Institut Pasteur [to 14 Nov 2020]
https://www.pasteur.fr/en/press-area
Press documents
No new digest content identified.

 

IRC International Rescue Committee [to 14 Nov 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
As COVID cases surpass 120,000 in Jordan, refugees struggle to feed their families
November 12, 2020

 

IVAC [to 14 Nov 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

 

IVI [to 14 Nov 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

 

JEE Alliance [to 14 Nov 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 14 Nov 2020]
http://www.msf.org/
Latest [Selected Announcements]
Mediterranean migration
Carnage in the Mediterranean is the direct result of European state …
Press Release 13 Nov 2020

Coronavirus COVID-19 pandemic
MSF supports COVID-19 response in nursing homes in Czech Republic
Project Update 13 Nov 2020

Non-communicable diseases
Eight reasons why diabetes is a humanitarian emergency
Project Update 13 Nov 2020

Coronavirus COVID-19 pandemic
MSF supports nursing home staff as urgent appeal for medical personnel in …
Project Update 11 Nov 2020

Syria
Taking risks to survive as COVID-19 spreads in the northwest
Project Update 11 Nov 2020

Coronavirus COVID-19 pandemic
Governments must demand pharma make all COVID-19 vaccine deals public
Press Release 11 Nov 2020
:: Deals from pharmaceutical companies to develop COVID-19 vaccines are shrouded in secrecy, and details from them that are released reveal worrying terms.
:: At the same time, the six front running vaccine candidates have had a total of over US$12 billion of tax payer and public money poured into them.
:: MSF urges governments – which have provided funding to these companies – to demand transparency on vaccine licensing deals and on trial costs and data.

Geneva – Governments must urgently demand transparency from pharmaceutical corporations on all COVID-19 vaccine licensing agreements, as well as clinical trial costs and data, says Médecins Sans Frontières (MSF). The call comes as billions of dollars of taxpayer money have gone towards the development of these potential vaccines, and recently disclosed deals from pharmaceutical company AstraZeneca reveal worrying terms.

AstraZeneca has committed not to profit off any COVID-19 vaccines ‘for the duration of the pandemic’ and to sell the vaccine at cost, in a deal with Oxford University. However, another deal to develop a COVID-19 vaccine with Brazilian public research body Fundação Oswaldo Cruz (Fiocruz), recently revealed that AstraZeneca has given itself the power to declare the pandemic over as soon as July 2021. This means that, after July 2021, AstraZeneca could charge governments and other purchasers high prices for a vaccine that was entirely funded by public money.

Pharmaceutical corporations have a very poor track record of transparency across the board, from licensing deals and technology transfers to costs of R&D and clinical trial data. The little information that has been revealed around AstraZeneca’s not-for-profit promises should be a warning sign that pharma cannot be trusted to act in the interest of public health.

“As long as we don’t know what’s in these deals, pharma will continue to hold the power to decide who gets access when, and at what price,” said Kate Elder, Senior Vaccines Policy Advisor for MSF’s Access Campaign. “Without decisive action from governments demanding more transparency from companies, equitable access to COVID-19 vaccines is in jeopardy.”
“The public has the right to know what’s in these deals,” said Elder. “There is no place for secrets during a pandemic; there is too much at stake.”

The licensing deals struck for a number of other companies racing to develop COVID-19 vaccines also remain cloaked in secrecy, despite unprecedented levels of public funding. Over US$12 billion has been poured into the research and development (R&D), clinical trials and manufacture of six front-runner candidate COVID-19 vaccines…

 

National Vaccine Program Office – U.S. HHS [to 14 Nov 2020]
https://www.hhs.gov/vaccines/about/index.html
No new digest content identified.

 

NIH [to 14 Nov 2020]
http://www.nih.gov/news-events/news-releases
News Releases
Treatments for people with early COVID-19 infection is an urgent research focus
November 11, 2020 — Effective, early interventions would benefit individual patients and healthcare system.

Hydroxychloroquine does not benefit adults hospitalized with COVID-19
November 9, 2020 — The trial began after lab studies and preliminary reports suggested that hydroxychloroquine might have promise in treating SARS-CoV-2.

 

PATH [to 14 Nov 2020]
https://www.path.org/media-center/
Press Release
No new digest content identified.

 

Sabin Vaccine Institute [to 14 Nov 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 14 Nov 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
13 November 2020
Interactive TV series about HIV launched in Kyrgyzstan

12 November 2020
Updated dashboard supports differentiated HIV testing services

9 November 2020
Little progress in increasing comprehensive knowledge of HIV among young women in eastern and southern Africa

9 November 2020
“Someone has to start”: how a Haitian transgender activist is inspiring hope through visibility

 

UNICEF [to 14 Nov 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Press release
11/12/2020
Worldwide Measles Deaths Climb 50% from 2016 to 2019 Claiming Over 207,500 Lives in 2019

Press release
11/12/2020
Severe pneumonia leaves 4.2 million children desperate for oxygen each year

News note
11/11/2020
UNICEF and PAHO launch joint COVID-19 vaccine tender on behalf of COVAX Facility
[See COVID above for detail]

Press release
11/10/2020
100 days on from Beirut explosions, children and families affected remain in need of sustained support – UNICEF
Just one-third of UNICEF’s US$50 million appeal received, with increased funding vital to ensure long-term assistance for children

 

Unitaid [to 14 Nov 2020]
https://unitaid.org/
Featured News
11 November 2020 | Press releases
UnitaidExplore invests in second award to improve oxygen access
Geneva – Access to oxygen is one of the defining health equity issues of our time – and the COVID-19 pandemic has thrown this into sharp relief.
Healthcare facilities in low- and middle-income countries suffer from chronic shortages of medical oxygen, resulting in more than 2000 children dying every day from pneumonia.
On World Pneumonia Day 2020, Unitaid is pleased to announce the latest recipient of funding from its agility mechanism UnitaidExplore, following a call for innovations that expand access to oxygen.
The EssentialTech Centre, part of the Swiss Federal Institute of Technology (EPFL) in Lausanne, will become the second organisation to take forward an exciting innovation with backing from UnitaidExplore, following the first award to Vayu Global Health.
The $1.6 million funding will be used to develop a new, affordable oxygen concentrator designed for use in remote health centres, as well as an integrated oxygen delivery service…

 

Vaccination Acceptance Research Network (VARN) [to 14 Nov 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 14 Nov 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 14 Nov 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 14 Nov 2020]
https://wellcome.ac.uk/news
Explainer | 13 November 2020
Seven vital questions about the Pfizer-BioNTech Covid-19 vaccine
Preliminary data from phase three clinical trials has shown the Pfizer-BioNTech Covid-19 vaccine to be 90% effective – it is the first vaccine candidate to produce such positive results.
This is great news, but it raises lots of questions including, how does the vaccine work, is it safe, and when will it be available?

 

The Wistar Institute [to 14 Nov 2020]
https://www.wistar.org/news/press-releases
Press Releases
Nov. 13, 2020
The Wistar Institute Announces the Appointment of Scott Cooper, Ph.D., Richard G. Phillips, Jr., and Steven V. Abramson to Its Board of Trustees
PHILADELPHIA — (Oct. 13, 2020) — The Wistar Institute is pleased to welcome Scott Cooper, Ph.D., Richard G. Phillips Jr., Esq., and Steven V. Abramson, to its Board of Trustees. The new trustees bring diverse expertise and perspectives to the mission of the Institute…

 

WFPHA: World Federation of Public Health Associations [to 14 Nov 2020]
https://www.wfpha.org/
Latest News
16th World Congress on Public Health Came to a Close!
Nov 13 2020
More than 3,750 public health professionals and policymakers from 125 countries gathered online at a time when sharing science is more important than ever.
After 3 years of anticipation, the 16th World Congress on Public Health (WCPH) finally came to a close. The virtual event, which was co-organized by the World Federation of Public Health Associations (WFPHA), the European Public Health Association (EUPHA), and the Italian Society of Hygiene, Preventative Medicine, and Public Health (SItI) saw an incredible turnout as 3,750 participants tuned in virtually from across 125 countries. Inspiring presentations and meaningful discussions brought together public health professionals as they navigated challenges under the theme of “Public Health for the Future of Humanity: Analysis, Advocacy, and Action”.
309 total sessions were dedicated to covering topics under a 12-track scientific programme. Sessions related to topics including COVID-19, infectious diseases, public health advocacy, health workforce training, digital health, and environmental health were led by various leaders and experts across multiple sectors…

 

World Organisation for Animal Health (OIE) [to 14 Nov 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
OIE statement on COVID-19 and mink
Paris, 12 November 2020 – The risk of susceptible animals, such as mink, becoming a SARS-CoV-2 reservoir generates worldwide concern, as it could pose a continued public health risk and lead to future spillover events to humans. Recent surveillance findings in Denmark suggest that the SARS-CoV-2 virus, introduced into minks through contact with humans, is evolving through viral mutation and has been reintroduced to humans.

The OIE acknowledges that such events could have important public health implications. While the COVID-19 pandemic is currently sustained through human-to-human transmission, there are concerns that the introduction and circulation of new virus strains in humans could result in modifications of transmissibility or virulence and decreased treatment and vaccine efficacy. Yet, the full consequences remain unknown, and further investigation is needed to fully understand the impact of these mutations.

Close collaboration between animal and public health authorities is imperative to better identify and reduce the impact of this disease. Furthermore, a global One Health approach is needed to understand risks for animal and human health, as well as ecosystem health as a whole.

The OIE calls on countries to protect animal health and welfare, and consequently public health, by implementing effective risk management measures. Actions should be taken to:
:: Prevent the transmission of SARS-CoV-2 between humans and susceptible animals, by implementing national risk reduction strategies;

:: Monitor susceptible animals, such as mink and racoon dogs, as well as humans in close contact with them, for SARS-CoV-2 infection adopting a One Health approach. Active monitoring is recommended as it might be difficult to detect early infections in these animals, especially mink;

:: Report animal cases to the OIE through the World Animal Health Information System (WAHIS);

:: Share genetic sequences of SARS-CoV-2 viruses isolated from animals and other research findings with the global health community.

To support countries in the implementation of these measures, the OIE has developed guidelines for people working with susceptible farmed animals, as well as with wild mammals in the era of the COVID-19 pandemic.

The OIE will continue to engage with its members, experts and partners   notably the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO) to update technical guidance as new scientific findings and information become available.

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 14 Nov 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.

 

BIO [to 14 Nov 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 14 Nov 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 14 Nov 2020]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 14 Nov 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Innovative and generic & biosimilar pharmaceutical industries unite on commitment to equitable access to COVID-19 medicines and vaccines, while flagging where further help is needed from others
Published on: 10 November 2020
[See COVID above for detail]

Statement
IFPMA/IGBA “Considerations on equitable access to COVID-19 medicines and vaccines”
09 November 2020

Statement
IFPMA Statement for the resumed 73rd WHA on agenda item 13.3 Influenza preparedness
09 November 2020

 

PhRMA [to 14 Nov 2020]
http://www.phrma.org/
Selected Press Releases, Statements
Press Release
Understanding the emergency use authorization process for COVID-19 vaccines
November 12, 2020
Richard Moscicki, M.D. Executive vice president, Science and Regulatory Advocacy and chief medical officer at PhRMA

As the world continues to feel the impact of the COVID-19 pandemic, the biopharmaceutical industry is working around the clock to develop safe and effective vaccines to prevent infection, as well as new therapies to treat the coronavirus. A wide range of approaches are currently being tested in robust clinical trials, with participants from all walks of life, to improve the odds that one or more vaccine candidates will be successful in meeting this pressing need. These trials look at how the immune system responds to a vaccine, its effectiveness in producing immunity and the safety profile.

Recently, there have been a number of conversations about the role of the U.S. Food and Drug Administration (FDA) in reviewing different COVID-19 vaccine candidates, and exactly how they may be available for use outside the context of a clinical trial, including through the issuance of an emergency use authorization (EUA). An EUA is important to helping provide access to medical products during a public health emergency like COVID-19.

As vaccines continue being robustly tested for safety and efficacy, here are three things to keep in mind:
1) An Emergency Use Authorization is different than FDA licensure of a vaccine.
EUAs are used in certain types of emergencies, like COVID-19, when there is no adequate, approved and available alternative to the EUA product. During these situations, the Federal Food, Drug and Cosmetic Act permits the FDA to issue EUAs to facilitate access to medical interventions, such as vaccines. Importantly, however, an EUA is not the same as an FDA approval or licensure. For example, there are different evidentiary requirements for licensure of a Biologics License Application (BLA) and issuance of an EUA for a vaccine. Furthermore, an EUA expires upon termination of the relevant emergency declaration, whereas there is no “termination” of a BLA.

The FDA may issue an EUA, when, among other things, the agency determines that based on all of the available scientific evidence, the known and potential benefits of the vaccine outweigh the known and potential risks. To underscore this, FDA Commissioner Stephen Hahn has said repeatedly in recent weeks and months that the agency would only consider an EUA if it felt the risks associated with the vaccine were “much lower than the risks of not having a vaccine and the potential benefit of having a vaccine.”

The agency has further taken steps to ensure the robust vaccine candidate review process by engaging the Vaccines & Related Biological Products Advisory Committee (VRBPAC) to discuss the development and potential authorization of vaccines to prevent COVID-19 after issuing guidance on FDA’s recommendations for an EUA submission for a COVID-19 vaccine.

 

 

2) COVID-19 Emergency Use Authorization standards are robust.
Recently, the FDA issued guidance specifically on EUAs for COVID-19 vaccines. The recommendations include key information and data that FDA recommends to support issuance of an EUA, including chemistry, manufacturing and controls information, nonclinical and clinical data and regulatory and administrative information.

This FDA guidance clarifies that an assessment regarding any potential EUA for COVID-19 vaccines would be made on a case-by-case basis considering the target population, the characteristics of the vaccines, and the totality of the relevant available scientific evidence, including preclinical and human clinical study data on the vaccine’s safety and effectiveness. The FDA plans to convene an open session of its VRBPAC (in addition to the general session held on October 22) prior to issuance of any EUA for a COVID-19 vaccine to discuss the request and whether the available safety and effectiveness data support the authorization.

 

 

3) EUAs last only as long as the HHS declaration justifying EUAs and may be revised or revoked at any time.
An EUA may only be issued after the Secretary of Health and Human Services makes a declaration that certain emergency circumstances exist justifying an EUA. EUAs issued under such declaration last only so long as the declaration is in effect; the EUA ceases to be effective upon termination of such declaration.

The FDA also has the authority revoke or revise an EUA at any time. The agency is directed to “periodically review the circumstances and the appropriateness” of an EUA, and the “progress made with respect to approval” or licensure of a product authorized under an EUA. The FDA may revise or revoke an EUA if the criteria for issuance are no longer met or other circumstances make such revision or revocation “appropriate to protect the public health or safety.”

America’s biopharmaceutical companies are supportive of the FDA’s robust new EUA guidance that brings greater scientific transparency to the COVID-19 vaccine review process and have pledged ‘to make the safety and well-being of vaccinated individuals the top priority in development’ of these first vaccines.

Journal Watch

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

Risk Management Ethics

AMA Journal of Ethics
Volume 22, Number 11: E907-980 November 2020
https://journalofethics.ama-assn.org/issue/caring-native-americans

 

Risk Management Ethics
Patients’ rights to self-determination or clinicians’ professional judgments in some cases deviate from standard of care and challenge risk managers’ tendencies to implement routine legal risk-mitigation strategies. Risk managers’ roles on care teams are particularly key when patients don’t progress clinically, when patients do not feel safe or satisfied with their services, when interventions are not well coordinated, or when care is not safely, efficiently, or equitably executed. Risk managers’ collaborations with ethics consultants and clinicians in these cases help individuals and organizations respond well to complex questions at the intersections of professional caregiving, ethics, and law. Issue PDF

State of the Art and Science
Nov 2020
How Might Artificial Intelligence Applications Impact Risk Management?
John Banja, PhD
AI models might advance human welfare in unprecedented ways, but progress will not occur without substantial risks that will have to be managed.
AMA J Ethics. 2020;22(11):E945-951. doi: 10.1001/amajethics.2020.945

How Should Risks Posed by Decision Support Be Managed?

AMA Journal of Ethics
Volume 22, Number 11: E907-980 November 2020
https://journalofethics.ama-assn.org/issue/caring-native-americans

 

State of the Art and Science
Nov 2020
How Should Risks Posed by Decision Support Be Managed?
Daniel Nystrom, MS
Clinical decision supports create ethically complex risks and need to align patients’ and caregivers’ professed values.
AMA J Ethics. 2020;22(11):E952-955. doi: 10.1001/amajethics.2020.952.

What Is Ethically Informed Risk Management?

AMA Journal of Ethics
Volume 22, Number 11: E907-980 November 2020
https://journalofethics.ama-assn.org/issue/caring-native-americans

 

Medicine and Society
Nov 2020
What Is Ethically Informed Risk Management?
Alan J. Card, PhD, MPH, CPHQ, CPHRM
Framing risk management goals as patient centered and evidence based helps align them with goals of ethics.
AMA J Ethics. 2020;22(11):E965-975. doi: 10.1001/amajethics.2020.965.

The economic burden of measles in children under five in Bangladesh

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 14 Nov 2020)

 

The economic burden of measles in children under five in Bangladesh
This study estimated the economic cost of treating measles in children under-5 in Bangladesh from the caregiver, government, and societal perspectives.
Authors: Gatien de Broucker, Sayem Ahmed, Md. Zahid Hasan, Gazi Golam Mehdi, Jorge Martin Del Campo, Md. Wazed Ali, Md. Jasim Uddin, Dagna Constenla and Bryan Patenaude
Citation: BMC Health Services Research 2020 20:1026
Content type: Research article
Published on: 10 November 2020

Underreporting of the 5-year tetanus, diphtheria, pertussis and polio booster vaccination in the Danish Vaccination Register

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 14 Nov 2020)

 

Underreporting of the 5-year tetanus, diphtheria, pertussis and polio booster vaccination in the Danish Vaccination Register
In Denmark, vaccination coverage is measured using the Danish Vaccination Register (DDV). In general, the vaccination coverage is high, but for some vaccinations, the coverage is suboptimal with geographical v…
Authors: Sidsel Skou Voss, Ida Glode Helmuth, Camilla Hiul Suppli and Palle Valentiner-Branth
Citation: BMC Public Health 2020 20:1681
Content type: Research article
Published on: 10 November 2020

Young women’s autonomy and information needs in the schools-based HPV vaccination programme: a qualitative study

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 14 Nov 2020)

 

Young women’s autonomy and information needs in the schools-based HPV vaccination programme: a qualitative study
Until 2019, the English schools-based human papillomavirus (HPV) vaccination programme was offered to young women (but not young men) aged 12 to 13 years to reduce HPV-related morbidity and mortality. The aim …
Authors: Harriet Fisher, Karen Evans, Jo Ferrie, Julie Yates, Marion Roderick and Suzanne Audrey
Citation: BMC Public Health 2020 20:1680
Content type: Research article
Published on: 10 November 2020

Willingness to use HIV prevention methods among vaccine efficacy trial participants in Soweto, South Africa: discretion is important

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 14 Nov 2020)

 

Willingness to use HIV prevention methods among vaccine efficacy trial participants in Soweto, South Africa: discretion is important
Despite multiple available HIV prevention methods, the HIV epidemic continues to affect South Africa the most. We sought to understand willingness to use actual and hypothetical HIV prevention methods among pa…
Authors: Fatima Laher, Taibat Salami, Stefanie Hornschuh, Lerato M. Makhale, Mamakiri Khunwane, Michele P. Andrasik, Glenda E. Gray, Hong Van Tieu and Janan J. Dietrich
Citation: BMC Public Health 2020 20:1669
Content type: Research article
Published on: 7 November 2020

Original research: Does electronic consent improve the logistics and uptake of HPV vaccination in adolescent girls? A mixed-methods theory informed evaluation of a pilot intervention

BMJ Open
November 2020 – Volume 10 – 11
https://bmjopen.bmj.com/content/10/11

 

Original research
Original research: Does electronic consent improve the logistics and uptake of HPV vaccination in adolescent girls? A mixed-methods theory informed evaluation of a pilot intervention (3 November, 2020)
Tracey Chantler, Ellen Pringle, Sadie Bell, Rosie Cooper, Emily Edmundson, Heidi Nielsen, Sheila Roberts, Michael Edelstein, Sandra Mounier-Jack

Literature Review: Strategies for Addressing Language Barriers During Humanitarian Relief Operations

Disaster Medicine and Public Health Preparedness
Volume 14 – Issue 3 – June 2020
https://www.cambridge.org/core/journals/disaster-medicine-and-public-health-preparedness/latest-issue

 

Concepts in Disaster Medicine
Literature Review: Strategies for Addressing Language Barriers During Humanitarian Relief Operations
Carlo Rossi, Sylvain Grenier, Régis Vaillancourt
Published online by Cambridge University Press: 23 October 2019, pp. 343-351

Genomics in the era of COVID-19: ethical implications for clinical practice and public health

Genome Medicine
https://genomemedicine.biomedcentral.com/articles
[Accessed 14 Nov 2020]

 

Genomics in the era of COVID-19: ethical implications for clinical practice and public health
Genomic studies of patients with COVID-19, or exposed to it, are underway to delineate host factors associated with variability in susceptibility, infectivity, and disease severity. Here, we highlight the ethical implications—both potential benefits and harms—of genomics for clinical practice and public health in the era of COVID-19.
Authors: Gail Geller, Priya Duggal, Chloe L. Thio, Debra Mathews, Jeffrey P. Kahn, Lisa L. Maragakis and Brian T. Garibaldi
Citation: Genome Medicine 2020 12:95
Content type: Comment
Published on: 9 November 2020

The global governance of antimicrobial resistance: a cross-country study of alignment between the global action plan and national action plans

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 14 Nov 2020]

 

The global governance of antimicrobial resistance: a cross-country study of alignment between the global action plan and national action plans
Antimicrobial resistance (AMR) is a growing problem worldwide in need of global coordinated action. With the endorsement of the Global Action Plan (GAP) on AMR in 2015, the 194 member states of the World Health Organization committed to integrating the five objectives and corresponding actions of the GAP into national action plans (NAPs) on AMR. The article analyzes patterns of alignment between existing NAPs and the GAP, bringing to the fore new methodologies for exploring the relationship between globally driven health policies and activities at the national level, taking income, geography and governance factors into account.
Authors: Louise Munkholm and Olivier Rubin
Content type: Research
11 November 2020

Disability inclusion in humanitarian action

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

 

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

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

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

Spotlight on global health research

International Health
Volume 12, Issue 6, November 2020
https://academic.oup.com/inthealth/issue/12/6

 

EDITORIAL
Spotlight on global health research
David S Lawrence, Margaret Gyapong
International Health, Volume 12, Issue 6, November 2020, Pages 507–508, https://doi.org/10.1093/inthealth/ihaa082
Extract
Global health research is a discipline in which it is highly possible to cause more harm than good. Universally, the conduct of ethical research is bound by international principles and guidelines and its design and implementation are interrogated by funders and institutional review boards. Research in resource-limited settings is no different in this respect but poses additional ethical considerations due to the nature that the research is conducted alongside or within poorly resourced healthcare systems. The aim of this special issue is to identify work that acknowledges this complexity but demonstrates best practice in the…

Ethical research in global health emergencies: making the case for a broader understanding of ‘research ethics’

International Health
Volume 12, Issue 6, November 2020
https://academic.oup.com/inthealth/issue/12/6

 

COMMENTARY
Ethical research in global health emergencies: making the case for a broader understanding of ‘research ethics’
Katharine S Wright
International Health, Volume 12, Issue 6, November 2020, Pages 515–517, https://doi.org/10.1093/inthealth/ihaa053
Abstract
The ethical challenges of global health research become particularly acute in emergency contexts, and are exacerbated by historic inequities and imbalances in power and influence. Drawing on the findings of an international working group established by the Nuffield Council on Bioethics, this article argues for the need to take a broader approach to ‘research ethics’ as traditionally understood, to include the role of ‘duty-bearers’ such as funders, governments, research institutions and journals. An ‘ethical compass’ of three core values (equal respect, fairness and helping reduce suffering) supports ethical reflection at the level of policy, as well as on the ground.

Decolonising global health: transnational research partnerships under the spotlight

International Health
Volume 12, Issue 6, November 2020
https://academic.oup.com/inthealth/issue/12/6

 

ORIGINAL ARTICLES
Decolonising global health: transnational research partnerships under the spotlight
David S Lawrence, Lioba A Hirsch
International Health, Volume 12, Issue 6, November 2020, Pages 518–523, https://doi.org/10.1093/inthealth/ihaa073
Abstract
There are increasing calls to decolonise aspects of science, and global health is no exception. The decolonising global health movement acknowledges that global health research perpetuates existing power imbalances and aims to identify concrete ways in which global health teaching and research can overcome its colonial past and present. Using the context of clinical trials implemented through transnational research partnerships (TRPs) as a case study, this narrative review brings together perspectives from clinical research and social science to lay out specific ways in which TRPs build on and perpetuate colonial power relations. We will explore three core components of TRPs: participant experience, expertise and infrastructure, and authorship. By combining a critical perspective with recently published literature we will recommend specific ways in which TRPs can be decolonised. We conclude by discussing decolonising global health as a potential practice and object of research. By doing this we intend to frame the decolonising global health movement as one that is accessible to everyone and within which we can all play an active role.