COVID Vaccine Developer Announcements

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COVID Vaccine Developer Announcements

Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
Feb 19, 2021

Dr. Reddy’s Initiates Process for Emergency Use Authorization of Sputnik V
February 19, 2021
Dr. Reddy’s Laboratories Ltd today announced that it has initiated the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA) of the well-studied human adenoviral vector-based platform vaccine candidate, Sputnik V…
As part of the review process, Dr. Reddy’s will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by 21st February 2021.
In September 2020, Dr. Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India. The vaccine is currently undergoing the phase 3 clinical trial in India…
Ethics Approval Granted for Open Orphan’s COVID-19 Human Challenge Study Model
Call for volunteers to enroll in studies that will play a key part in developing effective vaccines and treatments for COVID-19
February 17, 2021

European Commission Purchases Additional 150 Million Doses of COVID-19 Vaccine Moderna
February 17, 2021

Coronavirus (COVID-19) Vaccinations

Our World in Data
Coronavirus (COVID-19) Vaccinations
Our World in Data and the SDG-Tracker are collaborative efforts between researchers at the University of Oxford, who are the scientific editors of the website content; and the non-profit organization Global Change Data Lab, who publishes and maintains the website and the data tools that make our work possible. At the University of Oxford we are based at the Oxford Martin Programme on Global Development.

Research and data: Hannah Ritchie, Esteban Ortiz-Ospina, Diana Beltekian, Edouard Mathieu, Joe Hasell, Bobbie Macdonald, Charlie Giattino, and Max Roser
Web development: Breck Yunits, Ernst van Woerden, Daniel Gavrilov, Matthieu Bergel, Shahid Ahmad, Jason Crawford, and Marcel Gerber

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

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

 

CDC – Coronavirus Disease 2019 (COVID-19) – Latest Updates
:: Overall US COVID-19 Vaccine Distribution and Administration Update as of Fri, 19 Feb 2021 06:00:00 EST Friday, February 19, 2021

 

FDA
Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Announcement – 02/26/2021 – 02/26/2021
The committee will meet in open session to discuss EUA of the Janssen Biotech Inc. COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older.

Vaccines and Related Biological Products Advisory Committee March 5, 2021 Meeting Announcement – 03/05/2021 – 03/05/2021
The Committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 – 2022 influenza season.

White House [U.S.]
Briefing Room
Fact Sheet: President Biden Announces New Actions to Expand and Improve COVID-19 Testing
February 17, 2021 • Statements and Releases
As the virus continues to spread throughout the world, and with new variants emerging, the facts are clear that it is critical that we vaccinate as many people as possible, as quickly as possible. Tomorrow at the G7, the President will announce that he is taking concrete steps to improve the health and the safety of Americans by protecting vulnerable populations worldwide. He will also call on G7 partners to prioritize a sustainable health security financing mechanism aimed at catalyzing countries to build the needed capacity to end this pandemic and prevent the next one.

COVID has shown us that no nation can act alone in the face of a pandemic. Today, President Biden is taking action to support the world’s most vulnerable and protect Americans from COVID-19.

Using money appropriated by a bipartisan Congressional vote in December 2020, the United States will provide an initial $2 billion contribution to Gavi, the Vaccine Alliance for the COVAX Advance Market Commitment, the innovative financing instrument of the COVAX Facility, which supports access to safe and effective vaccines for 92 low- and middle-income economies.

The United States will also take a leadership role in galvanizing further global contributions to COVAX by releasing an additional $2 billion through 2021 and 2022, of which the first $500 million will be made available when existing donor pledges are fulfilled and initial doses are delivered to AMC countries. In close cooperation with Gavi, this additional $2 billion in funding will serve to expand COVAX’s reach.  We also call on our G7 and other partners to work alongside Gavi, to bring in billions more in resources to support global COVID-19 vaccination, and to target urgent vaccine manufacturing, supply, and delivery needs.

Finally, at the G7 President Biden will reaffirm the U.S. commitment to global health security and advancing the Global Health Security Agenda.  All countries should have the capability to prevent, detect, and respond to outbreaks.  The COVID-19 pandemic and ongoing outbreaks of Ebola in the Democratic Republic of the Congo and Guinea highlight the need for sustainable health security financing to catalyze country capacity to prevent biological catastrophes…

Statement by National Security Advisor Jake Sullivan
February 13, 2021
The mission of the World Health Organization (WHO) has never been more important, and we have deep respect for its experts and the work they are doing every day to fight the COVID-19 pandemic and advance global health and health security. That is why President Biden rejected and reversed the Trump Administration’s decision to disengage from the WHO. But re-engaging the WHO also means holding it to the highest standards.  And at this critical moment, protecting the WHO’s credibility is a paramount priority. We have deep concerns about the way in which the early findings of the COVID-19 investigation were communicated and questions about the process used to reach them. It is imperative that this report be independent, with expert findings free from intervention or alteration by the Chinese government. To better understand this pandemic and prepare for the next one, China must make available its data from the earliest days of the outbreak. Going forward, all countries, including China, should participate in a transparent and robust process for preventing and responding to health emergencies — so that the world learns as much as possible as soon as possible.

Remarks by President Biden at Pfizer Manufacturing Site
February 19, 2021 • Statements and Releases

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

Fact Sheet: President Biden to Take Action on Global Health through Support of COVAX and Calling for Health Security Financing
February 18, 2021 • Statements and Releases

Press Briefing by White House COVID-19 Response Team and Public Health Officials
February 17, 2021 • Press Briefings

Statement by White House Press Secretary Jen Psaki on Cases of Ebola
February 16, 2021 • Statements and Releases

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

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

 

News: EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
Last updated: 16/02/2021
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V.
EMA’s human medicines committee (CHMP) will assess the vaccine, known as COVID-19 Vaccine Janssen, under an accelerated timetable. The Committee could issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust.
Such a short time for evaluation is only possible because EMA has already reviewed some data during a rolling review

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

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

 

Russia: Sputnik V – “the first registered COVID-19 vaccine”
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
Sputnik V granted emergency use authorization in Ghana
Press release, 20.02.2021
The vaccine was approved under the emergency use authorization procedure. Ghana has become the 31st country in the world and 5th state of Africa to register Sputnik V.

Sputnik V authorized in 30 countries
Press release, 19.02.2021
Sputnik V had been approved earlier in Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Republika Srpska (entity of Bosnia and Herzegovina), Lebanon, Myanmar, Pakistan, Mongolia, Bahrain, Montenegro, Saint Vincent and the Grenadines, Kazakhstan, Uzbekistan and Gabon and San Marino.

Sputnik V authorized in Gabon
Press release, 17.02.2021

Sputnik V certified in Uzbekistan
Press release, 17.02.2021

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

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

China promotes global vaccine equity
Updated: 2021-02-19 | CHINA DAILY
Nation uses its strength in production chains to help boost capacity, FM says
China is contributing its fair share to help ease the global shortfall in COVID-19 vaccines as it expands assistance to countries in dire need, advances vaccine-related cooperation with eligible partners, boosts vaccine exports and gears up production.
Concerns are lingering globally about the widening gap between immunity and development around the world as high-income nations acquire more doses of vaccine than poorer countries, observers and international health agencies have warned.
China has offered COVID-19 vaccine assistance to 53 developing countries at their request, and it has exported or is exporting vaccines to 22 nations, State Councilor and Foreign Minister Wang Yi said.
The nation has also been using its strength in production chains to help other countries manufacture vaccines in China or locally in order to boost global production capacity, Wang said on Wednesday via video link at a United Nations Security Council open briefing on ensuring equitable access to vaccines.
During the Spring Festival holiday, China delivered vaccine shipments to seven countries.
Leaders of countries such as Hungary greeted the shipments’ arrival at airports and expressed heartfelt thanks to China, Foreign Ministry spokeswoman Hua Chunying said at a daily news conference in Beijing on Thursday.
China has never sought geopolitical advantage in carrying out international cooperation on COVID-19 vaccines, never calculated any economic gains and never attached any political conditions, Wang said…

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

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

ICMRA COVID-19 Virus Variants Workshop
Co-chairs: Marion Gruber (FDA, US) and Marco Cavaleri (EMA, EU)
International Coalition of Medicines Regulatory Authorities [ICMRA]
10 February 2021
… The ICMRA works hop was organised in light of the possible spread of these new variants globally and the need to consider rapid updates of current vaccines. The objectives were to discuss current surveillance activities to monitor the spread of the variants, and minimal elements of data that would be required to swiftly approve updated versions of available vaccines against emerging variants of SARS-CoV-2…
[Excerpt]
3. Vaccines: Possible minimal requirements for regulatory approval, or updated versions, of already-approved vaccines
The focus of the discussion was on the generation of monovalent vaccines containing the spike protein from an emerging variant recognized to pose a significant public health threat because it has shown to escape immunity from current vaccines.  Multivalent vaccines against SARS-CoV-2 variants were not considered in this workshop.

 

There was consensus that large safety and efficacy studies, similar to those required for initial approval of COVID-19 vaccines, are not feasible and would not be compatible with the timeframe for a rapid regulatory decision responsive to public health needs.

Authorization under emergency use approval and approval of variant COVID-19 vaccines against a SARS-CoV-2 variant expressing the spike protein and made by the same manufacturer and process as the prototype COVID-19 vaccine shown to be safe and effective in clinical trials, could be considered based on clinical data bridging the immune response of the variant vaccine to the prototype parent vaccine for which efficacy has been demonstrated in clinical disease endpoint efficacy studies.

Assuming that much of the manufacturing process and controls, as well as the facilities for vaccine production, for the variant COVID-19 vaccine would be identical to that of the prototype COVID-19 vaccine and depending on platform specific aspects, data to be generated may be confined to critical aspect of product characterization, potency assay and stability.

In general, it was agreed that additional non-clinical safety studies would not be required. Data derived from animal challenge/protection studies in a relevant model could be considered supportive. However, clinical immunogenicity and safety data would provide primary evidence for determining the suitability of the variant vaccines.

Inference of efficacy would need to be supported by conducting clinical non-inferiority immunogenicity studies comparing the immune responses induced by a variant COVID-19 vaccine against the SARS-CoV-2 variant of concern to the immune responses induced by the prototype vaccine for which clinical studies demonstrated efficacy and when administered according to the authorized dose and dosing regimen.

Studies in seronegative adults showing non-inferiority after a primary series of the new variant vaccine against the variant strains compared to prototype vaccine against ancestral strain were discussed as critical evidence for inferring efficacy of the variant vaccine.

 

In addition, booster studies would provide evidence to support the use of the variant vaccine when administered as a booster to individuals who were already vaccinated with the prototype vaccine as a primary series according to the authorized dose and dosing regimen. In this case, one option would be to demonstrate non-inferiority of the variant booster response against the variant strain versus the immune response of the primary series of the prototype vaccine against the ancestral strain.

As no correlate of protection for COVID-19 vaccines has been established to date, immune markers best suited for inferring protection were briefly discussed. The majority view was that neutralizing antibodies would constitute the most suitable immune marker for conducting immuno-bridging studies despite the complexity of comparing results from assays against different strains.

T-cell responses are considered an important component of the immune response elicited by different vaccines contributing to protection, but it would not be feasible to measure them due to lack of currently available validated assays.

The size of the studies would be driven by pre-specified statistical success criteria and endpoints.  Safety data should be collected covering both solicited and unsolicited adverse events as part of the immunogenicity studies. The safety of the variant vaccine would likely not differ significantly from that of the prototype, however, should unexpected safety signals arise, the safety database may have to be extended.

 

The importance of post-authorization studies evaluating safety and effectiveness of the variant COVID-19 vaccines was stressed…

Emergencies

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 17 February 2021
:: “The polio programme brought women out into the workforce in an unprecedented way, says Dr. Olayinka. “Women were powerful mobilizers, particularly older, respected women and could enter any home. The polio programme was one of the first programmes bringing the women out, training them how to speak to other women and community members, which gave them a standing in the community. They also received some stipends which empowered them a bit financially.” Read more in our latest “Women Leaders in Polio Eradication” series.

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
:: Afghanistan: 1 cVDPV2 case and five cVDPV2 positive environmental samples
:: Pakistan: four WPV1 positive environmental samples
:: Côte d’Ivoire: one cVDPV2 case
:: Democratic Republic of the Congo (DR Congo): two cVDPV2 cases
:: Egypt: two cVDPV2 positive environmental samples
:: Ethiopia: three cVDPV2 cases
:: Kenya: one cVDPV2 positive environmental sample
:: Mali: one cVDPV2 case
:: Sudan: one cVDPV2 case and three cVDPV2 positive environmental samples
:: Tajikistan: one cVDPV2 case

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Statement of the Twenty-Seventh Polio IHR Emergency Committee
19 February 2021 Statement
[Excerpts]
The twenty-seventh meeting of the Emergency Committee under the International Health Regulations (2005) (IHR) on the international spread of poliovirus was convened by the WHO Director-General on 1 February 2021 with committee members and advisers attending via video conference, supported by the WHO Secretariat.  The Emergency Committee reviewed the data on wild poliovirus (WPV1) and circulating vaccine derived polioviruses (cVDPV).  The following IHR States Parties provided an update at the video conference on the current situation in their respective countries: Afghanistan, Burkina Faso, the Republic of the Congo, Côte d’Ivoire, Egypt, the Islamic Republic of Iran, Liberia, Madagascar, Mali, Sierra Leone and Pakistan and Tajikistan…

…COVID-19
The committee was concerned that COVID-19 continues to have an impact on polio eradication at many levels.  Many of the polio affected countries are currently experiencing a second wave of COVID-19, notably Malaysia, Pakistan and Nigeria. Although resumption of SIAs is now a major focus of the polio program the effect of the pause in 2020 and the current second wave will hamper this resumption. There are ongoing signs of the impact of COVID-19 on surveillance, particularly with slow shipment and handling and reporting of samples for polio testing.   All these factors serve to heighten the risk of polio transmission.

The committee noted that since the beginning of the pandemic, the value of polio-funded staff and assets contributed to the COVID-19 response in more than 50 countries is estimated at USD $104 million. In view of the overwhelming public health imperative to end the COVID-19 pandemic, the POB has committed to the polio program’s continued support for the next phase of COVID-19 response, COVID-19 vaccine introduction and delivery, through existing assets, infrastructure and expertise in key geographies.

Conclusion
The Committee unanimously agreed that the risk of international spread of poliovirus remains a Public Health Emergency of International Concern (PHEIC) and recommended the extension of Temporary Recommendations for a further three months.  The Committee recognizes the concerns regarding the lengthy duration of the polio PHEIC, but concludes that the current situation is extraordinary, with clear ongoing and increasing risk of international spread and ongoing need for coordinated international response. The Committee considered the following factors in reaching this conclusion:

…Additional considerations
The committee welcomed the Emergency Use Listing of novel OPV2 but cautioned there was much to be done before the new vacccine could be expected to have a significant impact globally on the spread of cVDPV2. The phased replacement during 2021 of Sabin OPV2 with novel OPV2 is expected to substantially reduce the source of cVDPV2 emergence, transmission and subsequent risk of international spread.  Full licensure and pre-qualification of nOPV2 is not expected before 2022; therefore all countries at risk of cVDPV2 outbreak should consider preparing for novel OPV2 use under Emergency Use Listing procedure.

The committee welcomed the progress being made in individual countries that were facing huge challenges with both polio and COVID-19.  COVID-19 is also likely to continue to have a significant adverse impact on stopping polio transmission throughout 2021, with diversion of resources, barriers to successful polio campaign implementation and the consequential growing immunity gap.  However, the committee urged countries to look for where synergies can be built between polio and COVID -19 control, such as countering vaccine hesitancy, expanding and sharing testing resources, and vaccine management.  Countries also needed to make sure that local lockdowns and border restrictions were implemented in such a way as to avoid hampering specimen shipment and testing, particularly in West Africa where there are already constraints in lab capacity.  As testing for COVID-19 is strengthened, this should be done so as to strengthen lab capacity for other infectious diseases such as polio.  The committee urges affected countries to strengthen cross border cooperation as this appeared to be inconsistently carried out.

The committee also noted the risk of vaccine hesitancy could be exacerbated during the pandemic, so that adverse events during the development or future deployment of any COVID-19 vaccine could compound the existing issues around polio vaccines, particularly but not only in Pakistan.  Conversely, vaccine issues arising out of novel OPV2 or trivalent OPV use could adversely affect any future COVID-19 vaccine deployment.  The committee urged countries with particular issues around vaccine hesitancy to make preparations now to avert situations of greater vaccine refusals through education campaigns, activities to counter misinformation and rumors and wherever possible provide incentives to target populations such as multi-antigen campaigns and offering other health and wellbeing services (vitamins, anti-worming medication, soap etc).

The committee was also very concerned about the polio program funding gap which is developing in 2021 and beyond, noting several countries in Africa had been adversely affected by funding constraints.  The committee called on donors to maintain funding of polio eradication activities, as the potential for reversal of progress appears high, with many years of work undone easily and swiftly if WPV1 spreads outside the endemic countries.

Noting the serious situation in Afghanistan, the committee welcomed the recent agreement regarding mosque to mosque vaccination campaign activities but urged using multiple vaccines to avoid outbreaks of other vaccine preventable diseases such as measles.

Based on the current situation regarding WPV1 and cVDPV, and the reports provided by affected countries, the Director-General accepted the Committee’s assessment and on 19 February 2021 determined that the situation relating to poliovirus continues to constitute a PHEIC, with respect to WPV1 and cVDPV… 

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WHO/OCHA Emergencies

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

WHO Grade 3 Emergencies [to 20 Feb 2021]

Democratic Republic of the Congo – No new digest announcements [Last apparent update: 12 Jan 2021]
Mozambique floods – No new digest announcements identified [Last apparent update: 3 November 2020]
Nigeria – No new digest announcements identified [Last apparent update: 29 Jun 2020]
Somalia – No new digest announcements identified [Last apparent update: 17 July 2020]
South Sudan – No new digest announcements identified [Last apparent update: 4 February 2020]
Syrian Arab Republic – No new digest announcements identified [Last apparent update: 24 October 2020]
Yemen – No new digest announcements identified [Last apparent update: 30 June 2020]

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WHO Grade 2 Emergencies [to 20 Feb 2021]
Afghanistan – No new digest announcements identified [Last apparent update: 5 July 2020]
Angola – No new digest announcements identified [Last apparent update: 03 December 2020]
Burkina Faso – No new digest announcements identified [Last apparent update 04 février 2021]
Burundi – No new digest announcements identified [Last apparent update: 04 July 2019]
Cameroon – No new digest announcements identified [Last apparent update: 22 August 2019]
Central African Republic – No new digest announcements identified [Last apparent update: 12 June 2018]
Ethiopia – No new digest announcements identified [Last apparent update: 22 August 2019]
Iran floods 2019 – No new digest announcements identified [Last apparent update: 12 March 2020]
Iraq – No new digest announcements identified [Last apparent update: 16 December 2020]
Libya – No new digest announcements identified [Last apparent update: 7 October 2019]
Malawi Floods – No new digest announcements identified [Last apparent update: 09 October 2019]
Measles in Europe – No new digest announcements identified [Last apparent update: 16-12-2020]
MERS-CoV – No new digest announcements identified [Last apparent update: 8 July 2019]
Mozambique – No new digest announcements identified [Last apparent update: 03 November 2020]
Myanmar No new digest announcements identified [Last apparent update: :: 3 January 2021
Niger – No new digest announcements identified [Last apparent update: 11 février 2021]
occupied Palestinian territory – No new digest announcements identified [Last apparent update: 4 September 2019]
HIV in Pakistan – No new digest announcements identified [Last apparent update: 27 August 2019]
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements
Sudan – No new digest announcements identified [Last apparent update: 24 June 2020]
Ukraine – No new digest announcements identified [Last apparent update: 1 May 2019]
Zimbabwe – No new digest announcements identified [Last apparent update: 10 May 2019]

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WHO Grade 1 Emergencies [to 20 Feb 2021]

Chad – No new digest announcements identified [Last apparent update: 30 June 2018]
Djibouti – No new digest announcements identified [Last apparent update: 25 novembre 2020]
Kenya – No new digest announcements identified [Last apparent update: 11 December 2020]
Mali – No new digest announcements identified [Last apparent update: 3 May 2017]
Namibia – viral hepatitis – No new digest announcements identified [Last apparent update: 20 July 2018]
Tanzania – No new digest announcements identified [Last apparent update: 21 October 2020]

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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: Syrian Arab Republic: COVID-19 Response Update No. 15 – 16 February 2021

Yemen – No new digest announcements identified

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UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
East Africa Locust Infestation
:: Desert Locust situation update 16 February 2021

COVID-19 – No new digest announcements identified

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WHO & Regional Offices [to 20 Feb 2021]

WHO & Regional Offices [to 20 Feb 2021]

20 February 2021 Statement
WHO Director-General’s statement on Tanzania and COVID-19

19 February 2021 News release
World Waking Up To Vaccine Equity

19 February 2021 Statement
Statement of the Twenty-Seventh Polio IHR Emergency Committee

19 February 2021 News release
G7 leaders commit US$ 4.3 billion to finance global equitable access to tests, treatments and vaccines in 2021

18 February 2021 Departmental news
From paper to digital pathway: WHO launches first ‘SMART Guidelines’

17 February 2021 Departmental news
WHO announces updates on new molecular assays for the diagnosis of tuberculosis (TB) and drug resistance

16 February 2021 Joint News Release
COVAX Statement on WHO Emergency Use Listing for AstraZeneca/Oxford COVID-19 Vaccine

16 February 2021 Departmental news
WHO launches consolidated guidelines for malaria

16 February 2021 Departmental news
Consultation: Draft Global Strategy on WASH and NTDs 2021−2030

15 February 2021 Departmental news
Taeniasis: large-scale treatment shows interesting and far-reaching results

15 February 2021 News release
WHO lists two additional COVID-19 vaccines for emergency use and COVAX roll-out

15 February 2021 Departmental news
WHO launches new tools to help countries build effective childhood cancer programmes

 

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

WHO Region of the Americas PAHO
No new digest content identified

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

WHO European Region EURO
:: Overcoming COVID-19 and its collateral effects 19-02-2021
:: WHO reviews effect of physical activity on enhancing academic achievement at school 18-02-2021
:: New assessment shows high risk of introduction and spread from fur farming of the virus that causes COVID-19 17-02-2021
:: Aron Anderson – Cancer Ambassador for WHO/Europe 16-02-2021
:: Meet Florence, WHO’s digital health worker who can help you quit tobacco 15-02-2021

WHO Eastern Mediterranean Region EMRO
:: WHO Regional Director’s statement for virtual press briefing, 15 February
15 February 2021 – More than one year after the first case of COVID-19 was reported in our Region, the situation remains critical. Almost six million people have been infected, and almost 140,000 people have tragically died. In our Region, where people and health systems are constantly ravaged by conflict, natural disasters, and disease outbreaks, this virus has stretched us all…
:: Occupied Palestinian territory and Tunisia notified of indicative allocation of COVID-19 vaccine doses during first half of 2021 via COVAX Facility Cairo, 14 February 2021

WHO Western Pacific Region
:: Staying safe from COVID-19 during religious and cultural celebrations 16 February 2021

CDC/ACIP [U.S.] [to 20 Feb 2021]

CDC/ACIP [U.S.] [to 20 Feb 2021]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
CDC MEDIA TELEBRIEFING: National Forum on COVID-19 Vaccine
What: The Centers for Disease Control and Prevention (CDC) is hosting a virtual National Forum on COVID-19 Vaccine for vaccine practitioners and champions.
When: Monday, February 22 through Wednesday, February 24, 2021
Background: The forum supports the Biden-Harris Administration’s goals of mounting safe, effective, and comprehensive COVID-19 vaccine implementation strategies. It will facilitate information exchange and provide participants with practical information that can be applied in their communities.

ACIP Meeting – February 24-25, 2021
Virtual meeting. No registration is required.
Meeting time, 9:30am – 5:30pm EST
Webcast link: http://www.ustream.tv/channel/VWBXKBR8af4
Draft Agenda
Agenda references:
:: Rabies Vaccines
:: Dengue Vaccine
:: Ebola Vaccine
:: Hepatitis Vaccine
:: Pneumococcal Vaccines
:: Zoster Vaccines
:: Influenza Vaccines
:: Cholera Vaccine
:: Orthopoxviruses Vaccines

MMWR News Synopsis Friday, February 19, 2021
:: Decline in Receipt of Vaccines by Medicare Beneficiaries During the COVID-19 Pandemic — United States, 2020
After the COVID-19 emergency declaration in March 2020, weekly routine vaccination rates among Medicare beneficiaries declined by up to 89% compared with the same period in 2019. Vaccination providers should reassure patients that vaccination services can be delivered safely and emphasize the importance of routine vaccination to protect their health during the COVID-19 pandemic.
Investigators compared weekly rates of routine vaccination for four vaccines among Medicare beneficiaries during January 5–July 18, 2020 with rates from January 6–July 20, 2019. These include routine vaccines to protect against shingles, pneumococcal disease, tetanus, diphtheria, and whooping cough. The analysis found vaccination rates declined by up to 89% from 2019 to 2020 with similar declines across people from all racial/ethnic groups. However, adults from racial/ethnic minority groups had lower vaccination rates than did their white counterparts. When resuming in-person visits, vaccination providers should take actions to prevent the spread of COVID-19 and address patient concerns about exposure to COVID-19 during visits. Continued efforts by vaccination providers and public health officials will be needed to ensure routine vaccination rates among adults returns to pre-pandemic levels and to ensure protection of all older adults against vaccine-preventable diseases.

:: Care Outcomes Among Black or African American Persons with Diagnosed HIV in Rural, Urban, and Metropolitan Statistical Areas — 42 U.S. Jurisdictions, 2018
:: Trends in Use of Telehealth Among Health Centers During the COVID-19 Pandemic — United States, June 26–November 6, 2020
:: Required and Voluntary Occupational Use of Hazard Controls for COVID-19 Prevention in Non–Health Care Workplaces — United States, June 2020
:: Maximizing Fit for Cloth and Medical Procedure Masks to Improve Performance and Reduce SARS-CoV-2 Transmission and Exposure, 2021 (Early Release February 10, 2021)

Coronavirus Disease 2019 (COVID-19)- CDC

Coronavirus Disease 2019 (COVID-19)– CDC
Selected Resources
:: EARLY RELEASE: First Month of COVID-19 Vaccine Safety Monitoring – United States, December 14, 2020-January 13, 2021 Friday, February 19, 2021
:: Overall US COVID-19 Vaccine Distribution and Administration Update as of Fri, 19 Feb 2021 06:00:00 EST Friday, February 19, 2021
:: When Vaccine is Limited, Who Gets Vaccinated First? Friday, February 19, 2021
:: EARLY RELEASE: Detection of B.1.351 SARS-CoV-2 Variant Strain – Zambia, December 2020 Wednesday, February 17, 2021
:: EARLY RELEASE: First Identified Cases of SARS-CoV-2 Variant B.1.1.7 in Minnesota – December 2020-January 2021 Wednesday, February 17, 2021
:: How CDC is responding to SARS-CoV-2 variants globally Tuesday, February 16, 2021

China CDC

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

National Health Commission of the People’s Republic of China [to 20 Feb 2021]
http://en.nhc.gov.cn/
News
Feb 20: Daily briefing on novel coronavirus cases in China
On Feb 19, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 8 new cases of confirmed infections

China promotes global vaccine equity
Updated: 2021-02-19 | CHINA DAILY
Nation uses its strength in production chains to help boost capacity, FM says
China is contributing its fair share to help ease the global shortfall in COVID-19 vaccines as it expands assistance to countries in dire need, advances vaccine-related cooperation with eligible partners, boosts vaccine exports and gears up production…
[See China above for detail]

Head of WHO-led team says mission to Wuhan successful
2021-02-14
The WHO’s animal disease expert Peter Ben Embarek, who heads the WHO-led team to China, said the mission to study the origin of the virus had been successful, and the team had gained a better understanding of what happened in Wuhan in December 2019.

National Medical Products Administration – PRC [to 20 Feb 2021]
http://english.nmpa.gov.cn/news.html
News
Chinese mainland reports no new locally transmitted COVID-19 cases
2021-02-20
The Chinese mainland reported no new locally transmitted COVID-19 cases on Feb 19, the National Health Commission said Saturday.

Organization Announcements

Organization Announcements

 

Paul G. Allen Frontiers Group [to 20 Feb 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 20 Feb 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

 

BMGF – Gates Foundation [to 20 Feb 2021]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 20 Feb 2021]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

 

CARB-X [to 20 Feb 2021]
https://carb-x.org/
News
No new digest content identified.

 

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 20 Feb 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
Past weekly editions of Vaccines and Global Health: The Week in Review are available here.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 20 Feb 2021]
http://cepi.net/
Latest News
New infectious disease R&D grant opportunity launches for Canadian researchers
18 Feb 2021
By Jodie Rogers
CEPI and the Canadian Institutes of Health Research Institute of Infection and Immunity (CIHR-III), one of the 13 virtual institutes of Canada’s federal funding agency for health research, CIHR, have today launched the CIHR-CEPI Leadership Award for Excellence in Vaccine Research for Infectious Diseases of Epidemic Potential funding opportunity.
The award is a new two-year grant funding opportunity for up to six independent mid-career researchers in Canada to pursue projects—co-developed alongside CEPI—to expedite the development of vaccines against emerging infectious diseases, including COVID-19. The Request for Applications is now available on the CIHR-III website in English and in French...

COVAX Statement on WHO Emergency Use Listing for AstraZeneca/Oxford COVID-19 Vaccine
Geneva / New York / Oslo – 16 February 2021 The Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance (Gavi), and the World Health Organization (WHO), as co-leads of the COVAX initiative for equitable global access to COVID-19 vaccines, alongside key delivery partner UNICEF, are pleased to welcome the news that two versions of the AstraZeneca/Oxford COVID-19 vaccine have been given WHO Emergency Use Listing (EUL). Yesterday’s announcement means that two versions of the AstraZeneca/Oxford vaccine, produced by AstraZeneca-SK Bioscience (AZ-SKBio) and the Serum Institute of India (AZ-SII), are now available for global rollout through the COVAX Facility…

 

DARPA – Defense Advanced Research Projects Agency [to 20 Feb 2021
https://www.darpa.mil/
News
No new digest content identified.

Duke Global Health Innovation Center [to 20 Feb 2021]
https://dukeghic.org/
Launch and Scale Speedometer
No new digest content identified.

 

EDCTP [to 20 Feb 2021]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
No new digest content identified.

 

Emory Vaccine Center [to 20 Feb 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Commission [to 20 Feb 2021]
http://europa.eu/rapid/search-result.htm?query=18&locale=en&page=1
Latest
Press release 19 February 2021
G7: EU to support COVID-19 vaccination strategies and capacity in Africa
The President of the European Commission, Ursula von der Leyen, has announced today €100 million in humanitarian assistance to support the rollout of vaccination campaigns in Africa, which are spearheaded by the Africa Centres for Disease Control and Prevention (Africa CDC).

Press release 19 February 2021
New EU project to support readiness for vaccination efforts and resilient health systems in the Western Balkans
The European Union in partnership with the World Health Organisation (WHO) has launched a new regional project worth over €7 million to support safe and effective vaccination of the populations across the Western Balkans.

Press release 19 February 2021
EU doubles contribution to COVAX to €1 billion to ensure safe and effective vaccines for low and middle-income countries
The European Union has announced today an additional €500 million for the COVAX Facility, doubling its contribution to date for the global initiative that is leading efforts to secure fair and equitable access to safe and effective COVID-19 vaccines in low and middle-income countries.

News 17 February 2021
Von der Leyen announces the start of HERA Incubator to anticipate the threat of coronavirus variants
The HERA Incubator will bring together science, industry and public authorities, and leverage all available resources to enable Europe to respond to this challenge.

Press release 17 February 2021
Coronavirus: Commission approves second contract with Moderna to ensure up to additional 300 million doses
Today, the European Commission approved a second contract with the pharmaceutical company Moderna, which provides for an additional purchase of 300 million doses (150 million in 2021 and an option to purchase an additional 150 million in 2022) on behalf of all EU Member States.

 

European Medicines Agency [to 20 Feb 2021]
http://www.ema.europa.eu/ema/
News & Press Releases
News: EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
Last updated: 16/02/2021
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V.
EMA’s human medicines committee (CHMP) will assess the vaccine, known as COVID-19 Vaccine Janssen, under an accelerated timetable. The Committee could issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust.
Such a short time for evaluation is only possible because EMA has already reviewed some data during a rolling review

 

European Vaccine Initiative [to 20 Feb 2021]
http://www.euvaccine.eu/
Latest News
EVI
17 Feb 2021
EVI to lead Immune Monitoring in pan-European vaccine trial network, VACCELERATE
EVI to lead Immune Monitoring in pan-European vaccine trial network, VACCELERATE, as part of €150 million EU investment in research to counter coronavirus variants.
The European Commission announced today a €150 million investment for research to counter coronavirus variants. As part this “European Health Emergency Preparedness and Response Authority (HERA) Incubator” programme, Horizon 2020 funding will support the rapid establishment of a new EU-wide vaccine trial network called VACCELERATE. The grant agreement was signed today between representatives of the VACCELERATE consortium and the European Commission.
VACCELERATE will receive a €12 million grant and involves 26 partners, including the European Vaccine Initiative (EVI), in 16 Member States (AT, BE, CY, DE, DK, EL, ES, FR, IE, IT, LT, NL, PL, PT, SE, SK) and 5 associated countries (CH, IL, NO, RS, TR). VACCELERATE network, led by University Hospital Cologne, will act as a single entry point for vaccine developers, including SMEs, who are looking for European infrastructure to carry out vaccine trials. The consortium will work closely with the European Medicines Agency (EMA) to enable clinical trials for COVID-19 vaccines and prepare Europe for other emerging infectious diseases in the future.
EVI will have a key role in the project by leading the immune monitoring activities, which will focus on compiling, standardizing and prioritizing a comprehensive catalogue of immunological and genetic assays for COVID-19 vaccines. This will involve close collaboration with consortium partners as well as with other initiatives and networks that strive to standardise assessment of COVID-19 vaccines…

 

FDA [to 20 Feb 2021]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
:: February 19, 2021 – Coronavirus (COVID-19) Update: February 19, 2021

 

:: February 18, 2021 – COVID-19 Update: USDA, FDA Underscore Current Epidemiologic and Scientific Information Indicating No Transmission of COVID-19 Through Food or Food Packaging

 

:: February 16, 2021 – Coronavirus (COVID-19) Update: February 16, 2021

 

FDA – COVID-19 Vaccines [to 20 Feb 2021]
www.fda.gov/covid19vaccines
News and Updates; Upcoming Events
No new digest content identified.

 

Fondation Merieux [to 20 Feb 2021]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation co-organized event
MERACON: Returning to rabies elimination in 2021 webinar
February 26, 2021 – 9:00am -12:00pm (CET)
Context
The COVID-19 pandemic has hampered global travel and has placed a strain on public health systems globally. Because of this, many rabies activities were postponed or cancelled in 2020. Similarly, the planned in-person regional MERACON workshop that was initially scheduled for mid-2020 was postponed to 2021. As a means to continue remote support, foster collaboration and continue to drive progress towards rabies elimination in the MERACON countries, the MERACON steering committee has scheduled a digital meeting in webinar format. This webinar will act as a precursor to a more detailed workshop later in the year which we hope to host in-person (COVID-19 restrictions permitting).

 

Gavi [to 20 Feb 2021]
https://www.gavi.org/
News Releases
G7 backs Gavi’s COVAX Advance Market Commitment to boost COVID-19 vaccines in world’s poorest countries
19 February 2021

Gavi signs memorandum of understanding with Novavax on behalf of COVAX Facility
18 February 2021

COVAX Statement on WHO Emergency Use Listing for AstraZeneca/Oxford COVID-19 Vaccine
16 February 2021
[See COVID above for detail on these announcements]

 

GHIT Fund [to 20 Feb 2021]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
Press Releases
No new digest content identified.

 

Global Fund [to 20 Feb 2021]
https://www.theglobalfund.org/en/news/
News & Stories
No new digest content identified.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 20 Feb 2021]
https://www.glopid-r.org/news/
News
No new digest content identified.

 

Hilleman Laboratories [to 20 Feb 2021]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 20 Feb 2021]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
Science, 19 FEBRUARY 2021 • VOL 371 ISSUE 6531
Editorial: A univer sal coronavirus vaccine
Wayne C . Koffi, chief executive officer of the Human Vaccines Project; Seth Berkley, chief executive officer of Gavi, The Vaccine Alliance, Geneva, Switzerland.
[See COVID above for detail]

 

IAVI [to 20 Feb 2021]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
No new digest content identified.

 

 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
ICMRA COVID-19 Virus Variants Workshop
10 February 2021
Co-chairs: Marion Gruber (FDA, US) and Marco Cavaleri (EMA, EU)
[See COVID above for detail]

 

 

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

 

 

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

 

IFRC [to 20 Feb 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Kazakhstan
Kazakhstan: IFRC and Red Crescent launch bot to counter COVID misinformation
A social media chatbot has been launched in an innovative bid to share accurate, trusted information in a country with one of the world’s highest rates of vaccine hesitancy
19 February 2021

UN Security Council session on COVID-19: IFRC warns of combined dangers of mistrust and vaccine inequity
17 February 2021
[See COVID above for detail]

Africa, Guinea
Ebola outbreak in Guinea: Red Cross calls for a response that is “faster than the virus”
A network of more than 700 trained Red Cross volunteers has been activated as part of a first wave of response to the new Ebola outbreak in the rural community of Gouéké in Guinea’s N’Zerekore prefecture.
15 February 2021

 

Institut Pasteur [to 20 Feb 2021]
https://www.pasteur.fr/en/press-area
Press release 18.02.2021
Improving immunotherapies for blood cancers: real-time exploration in the tumor
Monoclonal antibodies are part of the therapeutic arsenal for eliminating cancer cells. Some make use of the immune…

 

IRC International Rescue Committee [to 20 Feb 2021]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
IRC joins #FirstRespondersFirst initiative to help humanitarian staff manage the psychological toll of responding to COVID-19 on the frontlines
February 18, 2021

Press Release
As new Ebola outbreaks emerge in the DRC and Guinea, the IRC calls for swift action and funding for frontline aid agencies to stop the spread
February 15, 2021

 

IVAC [to 20 Feb 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

 

IVI [to 20 Feb 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

 

JEE Alliance [to 20 Feb 2021]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

Johns Hopkins Center for Health Security [to 20 Feb 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
Health Security Releases Special Feature on Infodemics
February 19, 2021

New Report: Staying Ahead of the Variants: Policy Recommendations to Identify and Manage Current and Future Variants of Concern
February 16, 2021
The Johns Hopkins Center for Health Security released a new report on the status of SARS-CoV-2 surveillance, sequencing, and variant characterization and actions the U.S. government should take to increase capacity to respond to new virus variants.
The 3 new concerning variants of SARS-CoV-2 could make the virus spread more easily or make therapeutics and vaccines for COVID-19 less effective. And as the pandemic unfolds, more variants will emerge and spread…
PDF: https://www.centerforhealthsecurity.org/our-work/publications/staying-ahead-of-the-variants

 

MSF/Médecins Sans Frontières [to 20 Feb 2021]
http://www.msf.org/
Latest [Selected Announcements]
Guinea
Five questions on the Ebola outbreak in Guinea
Interview 19 Feb 2021

Coronavirus COVID-19 pandemic
Southern Africa needs the right COVID-19 vaccines, at the right price – right now
Press Release 18 Feb 2021

Myanmar
MSF concerned for welfare of healthcare workers and people in Myanmar
Statement 17 Feb 2021

Iraq
Severe COVID-19 patients in Iraq “were almost sure to die”
Project Update 16 Feb 2021

 

National Vaccine Program Office – U.S. HHS [to 20 Feb 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
NVAC Meeting – February 4-5, 2021
Agenda

 

NIH [to 20 Feb 2021]
http://www.nih.gov/news-events/news-releases
News Releases
To end HIV epidemic, we must address health disparities
February 19, 2021 — Expert report cites unequal progress in Southern U.S. and among marginalized groups.

NIH funds study to evaluate remdesivir for COVID-19 in pregnancy
February 17, 2021 — The study will be conducted at 17 sites in the continental United States and Puerto Rico.

 

PATH [to 20 Feb 2021]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

 

Sabin Vaccine Institute [to 20 Feb 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 20 Feb 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
15 February 2021
Félix Tshisekedi, President of the Democratic Republic of the Congo and 2021 African Union Chair, calls on his peers to learn from HIV and strengthen health systems

15 February 2021
Tuberculosis testing gap among people living with HIV is narrowing

 

UNHCR Office of the United Nations High Commissioner for Refugees [to 20 Feb 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected Announcements
Humanitarian agencies seek US$222 million to support Burundian refugees
16 February 2021

UNHCR alarmed at armed atrocities in eastern DR Congo
This is a summary of what was said by UNHCR spokesperson Babar Baloch – to whom quoted text may be attributed – at today’s press briefing at the Palais des Nations in Geneva.
16 February 2021

 

UNICEF [to 20 Feb 2021]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
No new digest content identified.

 

Unitaid [to 20 Feb 2021]
https://unitaid.org/
Featured News
19 February 2021
Germany contributes €20 million to Unitaid’s vital work on COVID-19
…The funding from Germany will contribute to the realisation of key aspects of the new ACT-Accelerator Therapeutics Partnership strategy (co-led by Unitaid and Wellcome), including advancing research on new treatments for COVID-19, ensuring affordable supplies and country preparedness so that low- and middle-income countries are able to use treatments effectively, further allowing for the procurement of proven treatments, as and when they become available….

19 February 2021
Unitaid welcomes the appointment of Dr. Ngozi Okonjo-Iweala to lead WTO

 

Vaccination Acceptance Research Network (VARN) [to 20 Feb 2021]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 20 Feb 2021]
http://www.vaccineconfidence.org/
News, Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 20 Feb 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

 

Wellcome Trust [to 20 Feb 2021]
https://wellcome.ac.uk/news
News
Explainer
What are human infection studies and why do we need them?
Human infection studies (also known as human challenge trials and controlled human infection models) have the power to rapidly accelerate the development of much-needed vaccines and treatments, including for Covid-19.
18 February 2021

Opinion
We’re backing the AMR Action Fund – this is what it means for antibiotic innovation
Wellcome joins a new collaboration of private and philanthropic partners in the search for new antibiotics to treat drug-resistant infections. Tim Jinks explains why this is important and why the next move needs to come from governments.
17 February 2021

 

The Wistar Institute [to 20 Feb 2021]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

 

WFPHA: World Federation of Public Health Associations [to 20 Feb 2021]
https://www.wfpha.org/
Latest News
No new digest content identified.

 

World Bank [to 20 Feb 2021]
http://www.worldbank.org/en/news/all
Selected News, Announcements
How COVID-19 is Affecting Companies Around the World
Date: February 17, 2021 Type: Infographic
Almost a year into the pandemic, nearly every business in the world has been affected by COVID-19, but performance has varied widely, even within countries and industries. Data collected through the World Bank firm surveys offer some glimpses into why, and how this may be relevant for policy.

Statement of Mr. Ferid Belhaj, Vice President of the Middle East and North Africa Region, The World Bank: Launch of the National COVID-19 Vaccine Campaign in Lebanon
As prepared for delivery
Date: February 14, 2021 Type: Statement

 

World Organisation for Animal Health (OIE) [to 20 Feb 2021]
https://www.oie.int/en/for-the-media/press-releases/2021/
Press Releases
No new digest content identified.

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 20 Feb 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Press Releases
No new digest content identified.

 

BIO [to 20 Feb 2021]
https://www.bio.org/press-releases
Press Releases
Fresh Perspective for BIO Operations, Sustainability
BIO taps MN biotech leader, Shaye Mandle, as new Chief Operating Officer
February 16, 2021
Washington, D.C.  – As the Biotechnology Innovation Organization (BIO) continues to restructure for a stronger and reinvigorated future, the organization announced new leadership for operations and sustainability. Shaye Mandle was named Chief Operating Officer (COO), effective March 1, 2021…

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 20 Feb 2021]
http://www.dcvmn.org/
News; Upcoming events
16 February 2021
WHO lists two COVID-19 vaccines from DCVMN members for emergency use

 

ICBA – International Council of Biotechnology Associations [to 20 Feb 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 20 Feb 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
The AMR Action Fund announces appointment of CEO, Henry B. Skinner, PhD
18 February 2021
Dr. Skinner will help ensure the AMR Action Fund achieves its mission to bring two to four new antibiotics to patients by the end of the decade and facilitate needed long-term policy solutions
FEBRUARY 18, 2021, BOSTON, MA — Today, the AMR Action Fund announced the appointment of its first Chief Executive Officer (CEO), Henry B. Skinner, PhD. The AMR Action Fund (www.AMRactionfund.com) is a ground-breaking partnership that was launched in July 2020 by more than 20 leading pharmaceutical companies. It aims to invest over US$1 billion to strengthen and accelerate clinical research of innovative new antibiotics that are addressing the most resistant bacteria and life-threatening infections, as well as provide technical support to biotech companies developing assets in this field. The AMR Action Fund is the largest collaborative venture ever created to address antimicrobial resistance (AMR)…

The AMR Action Fund announces its first non-industry investments, raising an additional US$140 million toward
18 February 2021
The AMR Action Fund, launched in July 2020, aims to bring 2 to 4 new antibiotics to patients by the end of the decade and facilitate needed long-term solutions
FEBRUARY 18, 2021, BOSTON — Today, the AMR Action Fund announced its first initial close with non-pharmaceutical industry investments of more than US$140 million from the Boehringer Ingelheim Foundation, the European Investment Bank (supported by the European Commission), and the Wellcome Trust. This adds to the initial investment from more than 20 leading biopharmaceutical companies that established the Fund as announced in July 2020. With this significant financial commitment from global foundations and development banks, the AMR Action Fund becomes the world’s largest public-private partnership supporting the development of new antibiotics. It demonstrates the type of commitment and collaboration across sectors that is urgently needed to address the global threat of antibiotic-resistant infections – also called antimicrobial resistance, or AMR…

Global Principles on Incentivizing Antibiotic R&D
IFPMA Policy Position :: 15 February 2021 :: 11 pages
PDF: https://www.ifpma.org/wp-content/uploads/2021/02/IFPMA-Global-Principles-on-Incentivizing-Antibiotic-RD.pdf
[Excerpt]
…We therefore call on all countries to take steps now to deliver a clear implementation roadmap by the end of 2021, make meaningful progress in implementation by 2023, and ensure full and effective implementation by 2025 at the latest of:
[1] New economic incentives, giving confidence to the private sector to invest in R&D at the level needed to create a robust antibiotic pipeline.
[2] Bespoke valuation of antibiotics, assessing and recognizing the full value antibiotics deliver to society and correcting their current under-valuation.
[3] Reimbursement reforms, to maintain availability of antibiotics on the market and to enable patient access to the most appropriate antibiotic to treat or prevent their infection.
While the solutions to these challenges will look different in different countries – there is no ‘one size fits all’ – this supportive policy framework is necessary to drive long-term investments in innovative antibiotics, throughout the discovery, development, and product lifecycle. In this paper, we propose a set of principles and models to establish such a framework, and we make an urgent call to Governments to drive these reforms to implementation, thereby delivering on recent G7 and G20 commitments..

 

PhRMA [to 20 Feb 2021]
http://www.phrma.org/
Selected Press Releases, Statements
The latest: What they are saying: Intellectual property protections vital to COVID-19 research, development and manufacturing
February 12, 2021
Strong and reliable IP protections – including patents – have supported America’s robust innovation ecosystem by promoting discovery, development, affordability and access to new treatments and cures. As our industry continues to expand vaccine production and deliver medicines to patients in need, reliable IP protections have been critical in supporting multiple research and development and manufacturing ramp-ups on COVID-19 vaccines and therapeutics. Innovators need strong and reliable IP protections to research, develop and manufacture new therapeutics and vaccines that will improve patients’ lives during the current pandemic and beyond…
Blog Post

Journal Watch

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

Racial and Ethnic Health Equity in the US: Part 1

AMA Journal of Ethics
Volume 23, Number 2: E83-211 Feb 2021
https://journalofethics.ama-assn.org/issue/racial-and-ethnic-health-equity-us-part-1

 

Racial and Ethnic Health Equity in the US: Part 1
Health equity is defined by the World Health Organization as the “absence of unfair and avoidable or remediable differences in health among social groups.” Domestically and globally, health inequity is not a historical accident. Inequity today is not unfortunate—that is, not a product of a mere turn of the proverbial cosmic wheel—but unjust—that is, generated by colonial, White supremacist policies and practices structured and maintained over time, forged to persist in hierarchies that serve some of us, our ancestors, and our descendants well and some of us, our ancestors, and our descendants ill. This first of a 2-part theme issue focuses specifically on racial and ethnic inequity in morbidity, mortality, and access to services that are endemic to American life. We investigate health inequity as a product of transgenerational patterns of oppression that must be remediated by all of us compassionately and more deliberately and quickly than they were created.

Should Remdesivir Be Used for the Treatment of Patients With COVID-19? Rapid, Living Practice Points From the American College of Physicians (Version 1)

Annals of Internal Medicine
February 2021 Volume 174, Issue 2
http://annals.org/aim/issue

 

Clinical Guidelines
Should Remdesivir Be Used for the Treatment of Patients With COVID-19? Rapid, Living Practice Points From the American College of Physicians (Version 1)
FREE
Amir Qaseem, MD, PhD, MHA, Jennifer Yost, RN, PhD, Itziar Etxeandia-Ikobaltzeta, PharmD, PhD,
… et al.

Artificial intelligence for good health: a scoping review of the ethics literature

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 20 Feb 2021)

 

Research article
Artificial intelligence for good health: a scoping review of the ethics literature
Authors: Kathleen Murphy, Erica Di Ruggiero, Ross Upshur, Donald J. Willison, Neha Malhotra, Jia Ce Cai, Nakul Malhotra, Vincci Lui and Jennifer Gibson
15 February 2021
Artificial intelligence (AI) has been described as the “fourth industrial revolution” with transformative and global implications, including in healthcare, public health, and global health. AI approaches hold promise for improving health systems worldwide, as well as individual and population health outcomes. While AI may have potential for advancing health equity within and between countries, we must consider the ethical implications of its deployment in order to mitigate its potential harms, particularly for the most vulnerable. This scoping review addresses the following question: What ethical issues have been identified in relation to AI in the field of health, including from a global health perspective?

Cost-effectiveness of pneumococcal vaccines among adults over 50 years old in low- and middle-income countries: a systematic review

Expert Review of Vaccines
Vol 19 (12) 2020
https://www.tandfonline.com/toc/ierv20/current

 

Cost-effectiveness of pneumococcal vaccines among adults over 50 years old in low- and middle-income countries: a systematic review
Yixue Shao & Charles Stoecker
Pages: 1141-1151
Published online: 22 Jan 2021

A framework for preferred practices in conducting culturally competent health research in a multicultural society

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 20 Feb 2021]

 

A framework for preferred practices in conducting culturally competent health research in a multicultural society
Improving the health and well-being of the whole population requires that health inequities be addressed. In an era of unprecedented international migration, meeting the health care needs of growing multicultu…
Authors: Lisa Woodland, Ilse Blignault, Cathy O’Callaghan and Ben Harris-Roxas
Citation: Health Research Policy and Systems 2021 19:24
Content type: Research
Published on: 18 February 2021
Abstract
Background
Improving the health and well-being of the whole population requires that health inequities be addressed. In an era of unprecedented international migration, meeting the health care needs of growing multicultural or multiethnic societies presents major challenges for health care systems and for health researchers. Considerable literature exists on the methodological and ethical difficulties of conducting research in a cross-cultural context; however, there is a need for a framework to guide health research in multicultural societies.
Methods
The framework was informed by “research on research” that we have undertaken in community and primary health care settings in Sydney, Australia. Case studies are presented as illustrative examples.
Results
We present a framework for preferred practices in conducting health research that is culturally informed, high-quality, safe, and actionable.
Conclusions
The framework is not intended to be universal, however many of its aspects will have relevance for health research generally. Application of the framework for preferred practices could potentially make health research more culturally competent, thus enabling enhanced policies, programmes and practices to better meet population health needs. The framework needs to be further tested and refined in different contexts.

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.

Declining Life Expectancy in the United StatesThe Need for Social Policy as Health Policy

JAMA
February 16, 2021, Vol 325, No. 7, Pages 605-702
https://jamanetwork.com/journals/jama/currentissue

 

Health Policy
Declining Life Expectancy in the United StatesThe Need for Social Policy as Health Policy
Atheendar S. Venkataramani, MD, PhD; Rourke O’Brien, PhD; Alexander C. Tsai, MD, PhD
free access
JAMA. 2021;325(7):621-622. doi:10.1001/jama.2020.26339
This Viewpoint reviews the social and economic drivers of declines in longevity in the US, especially among lower socioeconomic status groups, and proposes policy options for the Biden-Harris administration to mitigate the trend, including an increase in the federally mandated minimum wage.

Recalibrating the Use of Race in Medical Research

JAMA
February 16, 2021, Vol 325, No. 7, Pages 605-702
https://jamanetwork.com/journals/jama/currentissue

 

Recalibrating the Use of Race in Medical Research
John P. A. Ioannidis, MD, DSc; Neil R. Powe, MD, MPH, MBA; Clyde Yancy, MD, MSc
free access has audio
JAMA. 2021;325(7):623-624. doi:10.1001/jama.2021.0003
This Viewpoint reviews the way race has been used and misused in medical research and urges careful consideration by investigators of how its use might ameliorate or worsen health inequalities.

Race and Pharmacogenomics—Personalized Medicine or Misguided Practice?

JAMA
February 16, 2021, Vol 325, No. 7, Pages 605-702
https://jamanetwork.com/journals/jama/currentissue

 

Race and Pharmacogenomics—Personalized Medicine or Misguided Practice?
Christopher W. Goodman, MD; Allan S. Brett, MD
free access
JAMA. 2021;325(7):625-626. doi:10.1001/jama.2020.25473
This Viewpoint uses examples of recommendations for race-based pharmacogenetic testing to discuss flaws and inconsistencies with race and ethnicity as surrogates for biology, and the consequences of those deficiencies for clinical decision-making.

Clinical Trials of Broadly Neutralizing Monoclonal Antibodies for Human Immunodeficiency Virus Prevention: A Review

Journal of Infectious Diseases
Volume 223, Issue 3, 1 February 2021
https://academic.oup.com/jid/issue/223/3

 

REVIEWS
Clinical Trials of Broadly Neutralizing Monoclonal Antibodies for Human Immunodeficiency Virus Prevention: A Review
Sharana Mahomed, Nigel Garrett, Cheryl Baxter, Quarraisha Abdool Karim, Salim S Abdool Karim
The Journal of Infectious Diseases, Volume 223, Issue 3, 1 February 2021, Pages 370–380, https://doi.org/10.1093/infdis/jiaa377
The use of broadly neutralizing antibodies (bnAbs) is a promising approach that could help reduce the human immunodeficiency virus (HIV) epidemic burden. This review describes the status and available data on bnAbs in clinical trials for HIV prevention.

Guillain-Barré Syndrome After High-Dose Influenza Vaccine Administration in the United States, 2018–2019 Season

Journal of Infectious Diseases
Volume 223, Issue 3, 1 February 2021
https://academic.oup.com/jid/issue/223/3

 

VIRUSES
Editor’s Choice
Guillain-Barré Syndrome After High-Dose Influenza Vaccine Administration in the United States, 2018–2019 Season
Silvia Perez-Vilar, Mao Hu, Eric Weintraub, Deepa Arya, Bradley Lufkin
The Journal of Infectious Diseases, Volume 223, Issue 3, 1 February 2021, Pages 416–425, https://doi.org/10.1093/infdis/jiaa543
Using VSD and Medicare data, we rapidly evaluated a potential association between the 2018–2019 high-dose influenza vaccine and GBS and determined that, if a risk existed, it was similar in magnitude to that from prior seasons.

A Comparative Analysis of the Knowledge and Stigmatizing Attitude of Ghanaians and Nigerians towards COVID-19 Survivors

Journal of Refugee & Global Health
Volume 4, Issue 1 (2021)
https://ir.library.louisville.edu/rgh/

 

Original Research
A Comparative Analysis of the Knowledge and Stigmatizing Attitude of Ghanaians and Nigerians towards COVID-19 Survivors
Emmanuel Lamptey, Dorcas Serwaa, Maxwell Hubert Antwi, Theckla Ikome Ms, and Nkechi Odogwu

Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia

The Lancet
Feb 20, 2021 Volume 397 Number 10275 p641-766
https://www.thelancet.com/journals/lancet/issue/current

Articles
Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia
Denis Y Logunov, and the Gam-COVID-Vac Vaccine Trial Group

Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial

The Lancet
Feb 20, 2021 Volume 397 Number 10275 p641-766
https://www.thelancet.com/journals/lancet/issue/current

 

Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial
Peter Richmond, et al.
Interpretation
The SCB-2019 vaccine, comprising S-Trimer protein formulated with either AS03 or CpG/Alum adjuvants, elicited robust humoral and cellular immune responses against SARS-CoV-2, with high viral neutralising activity. Both adjuvanted vaccine formulations were well tolerated and are suitable for further clinical development.
Funding
Clover Biopharmaceuticals and the Coalition for Epidemic Preparedness Innovations.

Public policy and health in the Trump era

The Lancet
Feb 20, 2021 Volume 397 Number 10275 p641-766
https://www.thelancet.com/journals/lancet/issue/current

 

 

The Lancet Commissions
Public policy and health in the Trump era
Steffie Woolhandler,et al
This report by the Lancet Commission on Public Policy and Health in the Trump Era assesses the repercussions of President Donald Trump’s health-related policies and examines the failures and social schisms that enabled his election. Trump exploited low and middle-income white people’s anger over their deteriorating life prospects to mobilise racial animus and xenophobia and enlist their support for policies that benefit high-income people and corporations and threaten health. His signature legislative achievement, a trillion-dollar tax cut for corporations and high-income individuals, opened a budget hole that he used to justify cutting food subsidies and health care. His appeals to racism, nativism, and religious bigotry have emboldened white nationalists and vigilantes, and encouraged police violence and, at the end of his term in office, insurrection. He chose judges for US courts who are dismissive of affirmative action and reproductive, labour, civil, and voting rights; ordered the mass detention of immigrants in hazardous conditions; and promulgated regulations that reduce access to abortion and contraception in the USA and globally. Although his effort to repeal the Affordable Care Act failed, he weakened its coverage and increased the number of uninsured people by 2·3 million, even before the mass dislocation of the COVID-19 pandemic, and has accelerated the privatisation of government health programmes. Trump’s hostility to environmental regulations has already worsened pollution—resulting in more than 22 000 extra deaths in 2019 alone—hastened global warming, and despoiled national monuments and lands sacred to Native people. Disdain for science and cuts to global health programmes and public health agencies have impeded the response to the COVID-19 pandemic, causing tens of thousands of unnecessary deaths, and imperil advances against HIV and other diseases. And Trump’s bellicose trade, defence, and foreign policies have led to economic disruption and threaten an upswing in armed conflict.

Ethical considerations of COVID-19-related adjustments to clinical research

Nature Medicine
Volume 27 Issue 2, February 2021
https://www.nature.com/nm/volumes/27/issues/2

 

Comment | 25 January 2021
Ethical considerations of COVID-19-related adjustments to clinical research
Unexpected direct and indirect risks of participating in clinical trials have emerged during COVID-19 that investigators and institutional review boards may not be sure how to investigate. How should existing guidance and ethical frameworks for clinical trials be applied in a pandemic setting?
Nina S. Hsu, Saskia Hendriks & Christine Grady