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

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

 

FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review

April 23, 2021

Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.

 

The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine. During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts. The teams at FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).

 

The two agencies have determined the following:

:: Use of the Janssen COVID-19 Vaccine should be resumed in the United States. 

:: The FDA and CDC have confidence that this vaccine is safe and effective in preventing

    COVID-19.

:: The FDA has determined that the available data show that the vaccine’s known and

    potential benefits outweigh its known and potential risks in individuals 18 years of age

    and older.

:: At this time, the available data suggest that the chance of TTS occurring is very low, but

    the FDA and CDC will remain vigilant in continuing to investigate this risk.

:: Health care providers administering the vaccine and vaccine recipients or caregivers

    should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and   Caregivers, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.

 

CDC’s independent Advisory Committee on Immunization Practices met today to discuss the latest data on TTS, hearing from the vaccine manufacturer Janssen and the COVID-19 Vaccine Safety Technical (VaST) Subgroup, as well as a risk benefit analysis. ACIP is committed to be vigilant and responsive to additional information that could impact the risk benefit analysis of any of these vaccines. Vaccine safety monitoring will continue and any new information about TTS will be brought to ACIP as needed. 

 

“Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases. We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices. We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider,” said Janet Woodcock, M.D., Acting FDA Commissioner.

 

“Above all else, health and safety are at the forefront of our decisions,” said CDC Director Dr. Rochelle P. Walensky. “Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses of the Janssen COVID-19 administered – and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated. I continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccines are safe and effective, and they protect people from disease, hospitalization, and death. I urge anyone with questions about the COVID-19 vaccines to speak with their healthcare provider or local public health department.”…

White House [U.S.]
Briefing Room – Selected Major COVID Announcements
Remarks by President Biden on the COVID-19 Response and the State of Vaccinations
April 21, 2021 • Speeches and Remarks

FACT SHEET: President Biden to Call on All Employers to Provide Paid Time Off for Employees to Get Vaccinated After Meeting Goal of 200 Million Shots in the First 100 Days
April 21, 2021 • Statements and Releases

COVID Data Tracker [U.S.] April 3, 2021

 

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

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

 

 

European Medicines Agency
News & Press Releases
News: AstraZeneca’s COVID-19 vaccine: benefits and risks in context (new)
CHMP, Last updated: 23/04/2021
[Excerpt]
Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) is authorised in the EU to prevent COVID-19, which can cause severe disease and death. The disease can also have long-term consequences in people of all ages, including in otherwise healthy people.
The benefits of Vaxzevria outweigh its risks in adults of all age groups; however, very rare cases of blood clots with low blood platelets1 have occurred following vaccination.
To support national authorities making decisions on how to best use the vaccine in their territories, EMA’s human medicines committee (CHMP) has further analysed available data to put the risk of these very rare blood clots in the context of the vaccine’s benefits for different age groups and different rates of infection.
The analysis will inform national decisions on the roll out of the vaccine, taking into account the pandemic situation as it evolves and other factors, such as vaccine availability. The analysis could change as new data become available.
The Committee also considered available data on the use of the second dose…

 

News: Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna (new)
CHMP, Last updated: 23/04/2021
EMA’s human medicines committee (CHMP) has adopted two important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.

 

 

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021 (new)
CHMP, Last updated: 23/04/2021

 

 

News: COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets (new)
PRAC, Last updated: 20/04/2021
[Excerpt]
At its meeting of 20 April 2021, EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. PRAC also concluded that these events should be listed as very rare side effects of the vaccine.
In reaching its conclusion, the Committee took into consideration all currently available evidence including eight reports from the United States of serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome. As of 13 April 2021, over 7 million people had received Janssen’s vaccine in the United States.
All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currently available evidence, specific risk factors have not been confirmed…

 

 

European Commission
Statement 23 April 2021
Statement by Commissioner Kyriakides on the review by the European Medicines Agency of the AstraZeneca COVID-19 vaccine
Following a  formal request by the European Commission, the European Medicines Agency has reviewed additional vaccination and epidemiological data submitted by Member States in relation to the AstraZeneca vaccine.

Press release 20 April 2021
EU launches €100 million humanitarian initiative to support COVID-19 vaccination campaigns in Africa
Today, Commissioner for Crisis Management, Janez Lenarčič, will visit the Africa Centres for Disease control and Prevention (Africa CDC) in Addis Ababa. This visit marks the start of the implementation of the EU’s new €100 million humanitarian initiative in support of the COVID-19 vaccination campaigns in Africa. As announced by the President of the European Commission, Ursula von der Leyen, at the G7 meeting in February 2021, this €100 million initiative is part of the European Commission’s efforts to ensure equitable and fair access to safe and effective vaccines to all. By joining forces with the Africa CDC and other international partners, the European Commission aims to support a fast and safe rollout of Covid-19 vaccines in Africa…

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

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

Statement
UPDATE: Statement to Member States regarding thromboembolic events after vaccination with Janssen COVID-19 vaccine (Johnson & Johnson)
24 April 2021
Recommendations to AU Member States and health authorities
COVID-19 vaccines remain a key tool to prevent severe cases and deaths from COVID-19 infection. As such rapid access to safe and effective vaccines is paramount to the African Union vaccination strategy to achieve control of the pandemic.
The currently available evidence underscores the safety and efficacy of Janssen COVID-19 vaccine, notably in settings with high prevalence of the 501Y.V2 (or B.1.351) SARS CoV2 variant.
The position of Africa CDC is that the benefits of the Janssen COVID-19 vaccine outweigh the risks for people who receive it.
National health care authorities should reinforce vaccine safety monitoring.  Health care providers and clinicians should be informed of the risk of thrombotic thrombocytopenia in order to recognize and properly manage this very rare adverse event. Africa CDC will continue to monitor reports of adverse events following immunization, for all COVID-19 vaccines, including the Janssen COVID-19 vaccine, and will provide further guidance to Member States.

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

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

 

 

Russia: Sputnik V – “the first registered COVID-19 vaccine”
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
RDIF and Minapharm agree to produce over 40 million doses of the Sputnik V vaccine in Egypt
Press release, 22.04.2021

Production of Sputnik V launched in Argentina
Press release, 20.04.2021

Sputnik V demonstrates 97.6% efficacy according to analysis of data from 3.8 million vaccinated persons in Russia making it the most efficient COVID-19 vaccine in the world
Press release, 19.04.2021

RDIF and Hualan Biological Bacterin agree to produce over 100 million doses of the Sputnik V vaccine in China
Press release, 19.04.2021

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

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

 

 

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

 

 

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

17.02.2021 Guidelines for International Arrivals

17.02.2021 Algorithm for international arrivals
[For full size image click on link]

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 21 April 2021
:: The GPEI has made available reports from the Technical Advisory Group (TAG) meetings for Pakistan and Afghanistan which were held virtually in February and March this year.

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
:: Afghanistan: three cVDPV2 positive environmental samples
:: Pakistan: three WPV1 and one cVDPV2 positive environmental sample
:: Benin: one cVDPV2 positive environmental sample
:: Iran: one cVDPV2 positive environmental sample
:: Sierra Leone: three cVDPV2 positive environmental samples
:: Tajikistan: two cVDPV2 positive environmental samples

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

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 24 Apr 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]

::::::

WHO Grade 2 Emergencies [to 24 Apr 2021]
Malawi
:: Boosting equity to malaria prevention in Malawi through vaccination 22 April 2021

Afghanistan – No new digest announcements identified [Last apparent update: 5 July 2020]
Angola – No new digest announcements identified [Last apparent update: 16 March 2021]
Burkina Faso – No new digest announcements identified [Last apparent update: 01 avril 2021]
Burundi – No new digest announcements identified [Last apparent update: 04 July 2019]
Cameroon – No new digest announcements identified [Last apparent update: 22 August 2019]
Central African Republic – No new digest announcements identified [Last apparent update: 12 June 2018]
Ethiopia – No new digest announcements identified [Last apparent update: 22 August 2019]
Iran floods 2019 – No new digest announcements identified [Last apparent update: 2 March 2020]
Iraq No new digest announcements identified [Last apparent update: 11 April 2021]
Libya – No new digest announcements identified [Last apparent update: 7 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: 29 March 2021]
NigerNo new digest announcements identified [Last apparent update: 16 avril 2021]
occupied Palestinian territory – No new digest announcements identified [Last apparent update: 4 September 2019]
HIV in Pakistan – No new digest announcements identified [Last apparent update: 27 August 2019]
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements
Sudan – No new digest announcements identified [Last apparent update: 24 June 2020]
Ukraine – No new digest announcements identified [Last apparent update: 1 May 2019]
Zimbabwe – No new digest announcements identified [Last apparent update: 10 May 2019]

::::::

WHO Grade 1 Emergencies [to 24 Apr 2021]

Kenya
:: Kenya Third Wave Response: A time to synergize and re-energize 23 April 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]
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]

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

UN OCHA – Current Emergencies
COVID-19 – No new unique digest announcements identified

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

WHO & Regional Offices [to 24 Apr 2021]

WHO & Regional Offices [to 24 Apr 2021]
23 April 2021 Departmental news
Fair Pricing Forum ends with good intentions and new undertakings from WHO

23 April 2021 News release
ACT-Accelerator one year on

23 April 2021 News release
COVID-19 continues to disrupt essential health services in 90% of countries

22 April 2021 Statement
Statement of the Strategic Advisory Group of Experts (SAGE) on Immunization: Continued review of emerging evidence on AstraZeneca COVID-19 Vaccines
[See COVID above for detail]

21 April 2021 News release
World Malaria Day: WHO launches effort to stamp out malaria in 25 more countries by 2025

20 April 2021 Departmental news
RTS,S malaria vaccine reaches more than 650 000 children in Ghana, Kenya and Malawi through groundbreaking pilot programme

20 April 2021 Departmental news
Message from Director SRH/HRP

20 April 2021 Departmental news
WHO validates Gambia for having eliminated trachoma as a public health problem

19 April 2021 Departmental news
Applications for the 23rd WHO Expert Committee on Selection and Use of Essential Medicines available for public review and comment

19 April 2021 Statement
Statement on the seventh meeting of the International Health Regulations (2005) Emergency Committee regarding the coronavirus disease (COVID-19) pandemic
[See COVID above for detail]

 

::::::

Weekly Epidemiological Record, Vol. 96, No. 16, pp. 125–132 23 April 2021
:: WHO’s role in SARS-CoV-2 laboratory diagnostics: an end-to-end approach

 

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Cabo Verde attains zero local malaria transmission 22 April 2021
:: Boosting equity to malaria prevention in Malawi through vaccination 22 April 2021
:: Getting malaria prevention back on track 22 April 2021

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
:: Technical experts advise on how to ensure the best possible schooling during COVID-19 23-04-2021
:: WHO, FAO, and OIE call for stronger coordination in mitigating health threats 23-04-2021
:: COVAX helps make equitable access to COVID-19 vaccines a reality in the WHO European Region 23-04-2021
:: New report from WHO on health spending calls on governments not to repeat past mistakes when rebuilding from COVID-19 22-04-2021
:: Using the arts to improve health: WHO pioneers large-scale, arts-based health interventions 21-04-2021

WHO Eastern Mediterranean Region EMRO
:: World Immunization Week 2021 22 April 2021
:: Syria receives its first delivery of COVID-19 vaccines through the COVAX Facility
22 April 2021

WHO Western Pacific Region
No new digest content identified

MMWR News Synopsis Friday, April 23, 2021

MMWR News Synopsis Friday, April 23, 2021
:: Airport Traveler Testing Program for SARS-CoV-2 — Alaska, June–November 2020
:: COVID-19 Outbreaks in Correctional Facilities with Work-Release Programs — Idaho, July–November 2020
:: Laboratory Modeling of SARS-CoV-2 Exposure Reduction Through Physically Distanced Seating in Aircraft Cabins Using Bacteriophage Aerosol — November 2020 (Early Release April 14, 2021)

Coronavirus Disease 2019 (COVID-19)- CDC

Coronavirus Disease 2019 (COVID-19)– CDC
Selected Resources
Overall US COVID-19 Vaccine Distribution and Administration Update as of Fri, 23 Apr 2021 06:00:00 EST

COVID Data Tracker Recent Updates – 2021-04-22 – Updated Variant Proportions tab that shows variant proportions by region

4/23/21 COVID Data Tracker Recent Updates – 2021-04-22 – New Global Vaccinations tab displays vaccination counts and rates by country

4/23/21 ACIP Presentation Slides: April 23, 2021 Meeting

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 24 Apr 2021]
http://en.nhc.gov.cn/
News
April 24: Daily briefing on novel coronavirus cases in China
On April 23, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 9 new cases of confirmed infections.

Chinese health official stresses preventing COVID-19 import
2021-04-22

Over 204 mln COVID-19 vaccine doses administered across China
2021-04-23

China to produce more than 3b COVID-19 vaccines this year: Official
2021-04-21

National Medical Products Administration – PRC [to 24 Apr 2021]
http://english.nmpa.gov.cn/news.html
News
Xi says China committed to making vaccines a global public good
2021-04-21
President Xi Jinping on April 20 said China will honor its commitment of making vaccines a global public good…China will continue anti-COVID cooperation with the World Health Organization and other countries and do more to help developing countries defeat the virus, Xi said.

Organization Announcements

Organization Announcements
Editor’s Note:
Careful readers will note that the number and range of organizations now monitored in our Announcements section below has grown as the impacts of the pandemic have spread across global economies, supply chains and programmatic activity of multilateral agencies and INGOs.

 

Paul G. Allen Frontiers Group [to 24 Apr 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
[Website not responding at inquiry]

 

BARDA – U.S. Department of HHS [to 24 Apr 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
News
No new digest content identified.

 

BMGF – Gates Foundation [to 24 Apr 2021]
https://www.gatesfoundation.org/ideas/media-center
Press Releases and Statements
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 24 Apr 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 24 Apr 2021]
https://carb-x.org/
News
04.20.2021  |
CARB-X is funding Baebies Inc. to develop a rapid diagnostic for neonatal sepsis
CARB-X is awarding Baebies Inc., based in Durham, North Carolina, USA, up to $3.9 million to develop a rapid easy-to-use diagnostic for neonatal sepsis, a severe condition related to bacterial infections which, according to studies, kills an estimated 1.4 million young children world-wide each year.

04.19.2021  |
CARB-X is funding Phico Therapeutics to develop an engineered bacteriophage drug to treat ventilator-associated pneumonia caused by drug-resistant Pseudomonas aeruginosa
CARB-X is funding Phico Therapeutics, in Cambridge, UK, to develop a new intravenous engineered bacteriophage drug to treat ventilator-associated pneumonia caused by Pseudomonas aeruginosa, a serious problem in hospitals, intensive-care units and health-care settings.

 

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 24 Apr 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
:: Past weekly editions of Vaccines and Global Health: The Week in Review are available here.
:: [NEW] Webinar Recording – Posting of Informed Consent Content on Clinical Trials Registries Center for Informed Consent Integrity Webinar Series – 21 April 2021

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 24 Apr 2021]
http://cepi.net/
Latest News
No new digest content identified.

 

DARPA – Defense Advanced Research Projects Agency [to 24 Apr 2021
https://www.darpa.mil/news
News
4/19/2021
DARPA Selects Teams to Defend Against Chemical, Biological Threats from Inside and Out
Chemical and biological (CB) threats have become increasingly ubiquitous and diverse, presenting significant risks to warfighters in theater and stability operators during pandemic outbreaks. State-of-the-art personal protective equipment (PPE) can be bulky, heavy, and cumbersome, often severely limiting user mobility and performance. The Personalized Protective Biosystem (PPB) program aims to develop technology that reduces the need for burdensome protective equipment while increasing individual protection against CB threats.

 

Duke Global Health Innovation Center [to 24 Apr 2021]
https://dukeghic.org/
WEEKLY COVID VACCINE RESEARCH UPDATE
Last dated update: FRIDAY, April 2, 2021

 

EDCTP [to 24 Apr 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
24 April 2021
EDCTP-funded trial of R21/Matrix-M malaria vaccine shows efficacy of 77%
Positive results from an EDCTP-funded clinical trial in Burkina Faso, published as a preprint with The Lancet, demonstrate that the malaria vaccine candidate R21/Matrix-M is safe, immunogenic and has an efficacy of 77%, exceeding the WHO goal of 75% efficacy for malaria vaccines.
[University of Oxford news item: Malaria vaccine becomes first to achieve WHO-specified 75% efficacy goal]

 

Emory Vaccine Center [to 24 Apr 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Vaccine Initiative [to 24 Apr 2021]
http://www.euvaccine.eu/
Latest News
World Malaria Day 2021: Reaching the zero malaria target by 2030

 

FDA [to 24 Apr 2021]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
April 23, 2021 – FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review
[See COVID U.S. above for detail]

April 23, 2021 – Coronavirus (COVID-19) Update: April 23, 2021

April 21, 2021 – FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines
…As part of our regulatory processes for reviewing all manufacturing facilities, the FDA recently completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for the Johnson & Johnson COVID-19 Vaccine. As Johnson & Johnson announced last month, the FDA has not authorized this facility to manufacture or distribute any of Johnson & Johnson’s COVID-19 Vaccine or components and, to date, no COVID-19 vaccine manufactured at this plant has been distributed for use in the U.S.
The FDA’s inspections are thorough, and these assessments review the quality of manufacturing procedures, including records, staff training, facility operations, drug production and testing and the systems in place to ensure product quality. During an inspection of Emergent BioSolutions that ended Tuesday, the FDA cited a number of observations concerning whether the facility’s processes met our requirements and standards. These observations are outlined in our inspection closeout report, also known as a “FDA Form 483.”…

April 20, 2021 – Coronavirus (COVID-19) Update: April 20, 2021

 

Fondation Merieux [to 24 Apr 2021]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

 

Gavi [to 24 Apr 2021]
https://www.gavi.org/
News Releases
23 April 2021
France makes important vaccine dose donation to COVAX
[See COVAX above for detail]

 

GHIT Fund [to 24 Apr 2021]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
No new digest content identified.

 

Global Fund [to 24 Apr 2021]
https://www.theglobalfund.org/en/news/
News & Stories
Global Fund Applauds Netherlands’ Contribution to ACT-Accelerator
20 April 2021
The Global Fund warmly welcomed the announcement by the Netherlands of a contribution of €52 million to the Access to COVID-19 Tools (ACT) Accelerator – a groundbreaking global collaboration to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines.
Of the new funds, €12 million will be channeled through the Global Fund to strengthen its response to the COVID-19 pandemic while protecting gains made against HIV, tuberculosis, and malaria over the last two decades. The rest, €40 million, will be invested in the purchase of vaccines through COVAX – the vaccines pillar of the ACT-Accelerator. This latest commitment follows €85 million the Netherlands has contributed to the global response to COVID-19 since the pandemic began, bringing its total investment to date to €137 million…

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 24 Apr 2021]
https://www.glopid-r.org/news/
News
No new digest content identified.

 

Hilleman Laboratories [to 24 Apr 2021]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 24 Apr 2021]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
[Website not fully loading at inquiry]

 

IAVI [to 24 Apr 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
No new digest content identified.

 

ICRC [to 24 Apr 2021]
https://www.icrc.org/en/whats-new
Selected News Releases, Statements, Reports
No new digest content identified.

 

 

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

 

 

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

 

IFRC [to 24 Apr 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Europe, Greece, Italy, Serbia, Spain
COVID-19: IFRC warns Europe’s poorest countries are being left behind, as deaths hit grim milestone
As Europe reaches the grim milestone of 50 million infections and 1 million lives lost to COVID-19, IFRC calls for more equitable access to vaccination to counter disparities across countries and ensure no one is left behind.
21 April 2021

 

Institut Pasteur [to 24 Apr 2021]
https://www.pasteur.fr/en/press-area
Press release
21.04.2021
SARS-CoV-2: infection induces antibodies capable of killing infected cells regardless of disease severity
Drawing on epidemiological field studies and the French COVID hospital cohort coordinated by Inserm, teams from the…

 

IRC International Rescue Committee [to 24 Apr 2021]
http://www.rescue.org/press-release-index
Media highlights [Selected]
No new digest content identified.

 

IVAC [to 24 Apr 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

 

IVI [to 24 Apr 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
Webinar | COVID-19 and Public Governance: Effective Global Vaccination Strategies for Vaccine Access
While vaccination campaigns are rolled out across the globe and access to safe and effective COVID-19 vaccines come into sight, more work, funding and collaboration are still needed to overcome the tremendous health and economic consequences of this pandemic. In this crisis, international cooperation needs to succeed—also to set itself up for further challenges to come. Register below!
April 29, 2021 | 9:30 Berlin | 16:30 Seoul

 

JEE Alliance [to 24 Apr 2021]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

Johns Hopkins Center for Health Security [to 24 Apr 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 24 Apr 2021]
http://www.msf.org/
Latest [Selected Announcements
Malaria
Pumps, bicycles and satellites: fighting malaria in Burundi
Project Update 22 Apr 2021

Peru
COVID-19 leaves high numbers of deaths and overwhelmed hospitals in Peru
Press Release 20 Apr 2021

 

National Academy of Medicine – USA [to 24 Apr 2021]
https://nam.edu/programs/
Selected News/Programs
Upcoming Events:
Researching Novel Therapeutics in a Pandemic: Lessons from COVID-19 (April 22)
Implementation Science and Non-Vaccine Public Health Measures during COVID-19 (April 23)
Exploring Influenza Vaccine Critical Inputs, Technologies, and Logistics Day 1 (April 23)
Exploring Influenza Vaccine Critical Inputs, Technologies, and Logistics Day 2 (April 27)

 

National Vaccine Program Office – U.S. HHS [to 24 Apr 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

 

NIH [to 24 Apr 2021]
http://www.nih.gov/news-events/news-releases
News Releases
COVID-19 vaccine responses to be studied in people with immune deficits
April 23, 2021 — Enrollment begins at NIH Clinical Center.

Clinical trial of therapeutics for severely ill hospitalized COVID-19 patients begins
April 22, 2021 — Patients with acute respiratory failure may now enroll in NIH-sponsored trial.

Large NIH clinical trial will test polyclonal antibody therapeutic for COVID-19
April 21, 2021 — Study is part of an effort to speed development of the most promising treatments and vaccine candidates.

Large clinical trial to study repurposed drugs to treat COVID-19 symptoms
April 19, 2021 — Using an ACTIV master protocol, the trial will focus on potential interventions for mild-to-moderate illness.

 

UN OCHA Office for the Coordination of Humanitarian Affairs [to 24 Apr 2021]
https://www.unocha.org/
Press Releases
20 April 2021
United Nations launches $29 million appeal for St. Vincent and the Grenadines and other affected countries as volcano eruption continues

18 April 2021
United Nations Resident Coordinator and Humanitarian Coordinator for Syria, Imran Riza, condemns killing of two aid workers in Deir-Ez-Zor, Syria [EN/AR]

 

PATH [to 24 Apr 2021]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

 

Sabin Vaccine Institute [to 24 Apr 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 24 Apr 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
21 April 2021
Civil society from Asia and the Pacific join the first regional consultation on the High-Level Meeting on AIDS

19 April 2021
Regional network of people living with HIV launched in the Middle East and North Africa

19 April 2021
Less than 60% of pregnant women living with HIV in western and central Africa have access to services to stop vertical transmission of HIV

 

UNDP United Nations Development Programme [to 24 Apr 2021]
http://www.undp.org/content/undp/en/home/presscenter.html
Latest from News Centre
No new digest content identified.

 

UNESCO [to 24 Apr 2021]
http://en.unesco.org/news
Selected Latest News
Making COVID-19 Vaccine a “global public good” for its timely allocation to Africa
19/04/2021
…In this context, the Framework for Fair, Equitable and Timely Allocation of COVID-19 Vaccines in Africa, issued in January 2021 by Africa Centres for Disease Control and Prevention (Africa CDC) and the South African Medical Research Council (SAMRC), as well as the UNESCO Ethics Commissions’ Call for Global Vaccines Equity and Solidarity, issued in February 2021 as a joint statement by UNESCO International Bioethics Committee (IBC) and the World Commission on the Ethics of Scientific Knowledge and Technology (COMEST), needed to be reaffirmed for ensuring that a COVID-19 Vaccine is considered a “global public good” that is accessible to everyone, irrespective of ethnicity, nationality, gender, sexual orientation, race and religion. This is the rationale behind the Series of Community Engagement and Experience Sharing Virtual Workshops on Ethical Considerations in Covid-19 immunization campaigns for its fair, equitable and timely allocation in Africa, with the first of the series held on 14 April 2021.’’…

 

UNHCR Office of the United Nations High Commissioner for Refugees [to 24 Apr 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected News Releases, Announcements
UNHCR’s Grandi calls on the international community to stand with DR Congo
23 Apr 2021

 

 

Mounting death toll in the Central Mediterranean calls for urgent action
JOINT UNHCR/IOM PRESS RELEASE
23 Apr 2021

 

 

Data visualization reveals impacts of climate change on displacement
22 Apr 2021

 

 

UNHCR’s Protection Chief visits Cyprus, addresses challenges in access to asylum
22 Apr 2021

 

 

More refugees arrive in Chad following recent clashes in CAR
20 Apr 2021

 

 

Relocations in Brazil offer dignity and hope to thousands of Venezuelans
Joint UNHCR/IOM Press Release
20 Apr 2021

 

UNICEF [to 24 Apr 2021]
https://www.unicef.org/media/press-releases
Selected Press Releases, Statements
Statement 04/23/2021
UNICEF Executive Director Henrietta Fore’s remarks at the one-year anniversary of the Access to COVID-19 Tools Accelerator
As prepared for delivery

Press release 04/23/2021
COVID-19 continues to disrupt essential health services in 90 per cent of countries
Some signs of recovery emerging but major efforts required to restore and strengthen health services

Press release 04/22/2021
UNICEF Goodwill Ambassador David Beckham leads global vaccination drive during World Immunization Week
Global partners pledge a $1 donation for every like, share or comment on social media posts mentioning ‘UNICEF’ using the hashtag #VaccinesWork until the end of April

Statement 04/22/2021
Syria receives its first delivery of COVID-19 vaccines through the COVAX Facility
Joint Statement by UNICEF Regional Director for the Middle East and North Africa, Ted Chaiban, WHO Regional Director for the Eastern Mediterranean, Dr. Ahmad Al-Mandhari, and Gavi, the Vaccine Alliance Director of Country Support, Pascal Bijleveld

Press release 04/19/2021
Nine times more migrant children in Mexico over the past three months – UNICEF

 

Unitaid [to 24 Apr 2021]
https://unitaid.org/
Featured News
23 April 2021
World Malaria Day : Unitaid commits to ensure increased and equitable access to life-saving tools against malaria
Geneva – Ahead of World Malaria Day, marked annually on April 25, Unitaid reaffirms its strong commitment to combat malaria by increasing its efforts to prevent, control, and ultimately eliminate the disease.
The emergence of COVID-19 more than one year ago has thrown health systems into disarray and forced many countries to shift their focus and resources away from malaria. This threatens to reverse hard-won gains, particularly in the highest malaria burden countries where the rate of progress has slowed in recent years.
The World Health Organization (WHO) warns countries that disruptions to programmes that prevent and treat malaria could lead to a potential doubling of malaria deaths in sub-Saharan Africa in 2020 compared to 2018.
A new report by the Global Fund to Fight AIDS, Tuberculosis and Malaria highlights the urgent need to scale-up the adaptative measures adopted to counter the impact of COVID-19 to ensure the continuing delivery of lifesaving health services for malaria…

 

Vaccination Acceptance Research Network (VARN) [to 24 Apr 2021]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 24 Apr 2021]
http://www.vaccineconfidence.org/
News, Research and Reports
Coronavirus global impact
Launched April 2, 2020 and recurring every 3 days, Premise Data is utilizing its global network of Contributors to assess economic, social, and health sentiment surrounding the coronavirus (COVID-19).
[Data arrays do noy seem to loading]

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 24 Apr 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

 

Wellcome Trust [to 24 Apr 2021]
https://wellcome.ac.uk/news
News and reports
Explainer
What are human infection studies and why do we need them?
19 April 2021

 

The Wistar Institute [to 24 Apr 2021]
https://www.wistar.org/news/press-releases
Press Releases
Apr. 22, 2021
Low-dose Administration of MERS DNA Vaccine Candidate Induces Potent Immunity and Protects From Virus Challenge in Preclinical Models
Dose-sparing regimens and intradermal delivery have important implication for rapid clinical development of effective, well-tolerated and easy-to-distribute vaccines against MERS and other emerging coronaviruses.

 

WFPHA: World Federation of Public Health Associations [to 24 Apr 2021]
https://www.wfpha.org/
Latest News
Together We Can Overcome the COVID-19 Pandemic: Letters to G7 & G20
Apr 22, 2021
The COVID-19 pandemic is a global public health issue requiring a global solution with regional, national and local applicability. The extreme COVID-19 fatigue and uncertainty experienced by populations worldwide urgently requires both short-term and long-term practical solutions.
In countries that have been more successful in containing COVID-19, health and social professionals have been in leading roles formulating evidence-informed recommendations on the basis of best practice, and supporting societal engagement.
Therefore, the Coalition of Global Health, Primary Care and Social Work Professionals has sent an open letter to the Presidents of the 2021 G7 and G20 Summits to call on the G7 and G20 Summits to engage with the representatives of the Coalition to work directly on the co-design and co-production of local, national, regional and international strategies to effectively combat the COVID-19 global pandemic.
Together we can overcome the COVID-19 pandemic.
Letter to G7
Letter to G20

Advancing Essential Public Health Functions to Prevent the Next Pandemic
Apr 19, 2021
Advancing Essential Public Health Functions to Prevent the Next Pandemic
The Essential Public Health Functions (EPHFs) are a set of fundamental actions taken to achieve the public health goal of improving, promoting, protecting, and restoring the…

 

World Bank [to 24 Apr 2021]
http://www.worldbank.org/en/news/all
Selected News, Announcements
COVID 19: Debt Service Suspension Initiative
In the interest of greater transparency, this webpage offers a country-by-country accounting of DSSI participants and the amounts they owe to creditors, based on information from the World Bank’s International…
Date: April 23, 2021 Type: Brief

World Bank Financing for COVID-19 Vaccine Rollout Reaches $2 Billion
Date: April 20, 2021 Type: Press Release
[See COVID – Access above for detail]

World Bank Approves $30 Million to Support COVID-19 Vaccination Rollout in Rwanda
WASHINGTON, April 16, 2021 — The World Bank’s Board of Executive Directors approved  $30 million in additional financing to the Republic of Rwanda for the acquisition and deployment of safe and…
Date: April 16, 2021 Type: Press Release

 

World Customs Organization – WCO [to 24 Apr 2021]
http://www.wcoomd.org/
Latest News – Selected Items
20 April 2021
The SAFE Working Group endorses the SAFE 2021 Framework of Standards after a successful Review Cycle and paves the way to prioritize its activities in line with the WCO’s COVID-19 Action Plan

 

World Organisation for Animal Health (OIE) [to 24 Apr 2021]
https://www.oie.int/en/for-the-media/press-releases/2021/
Press Releases
No new digest content identified.

 

WTO – World Trade Organisation [to 24 Apr 2021]
http://www.wto.org/english/news_e/news_e.htm
WTO News and Events
Members note sharp downturn in LDCs’ trade, discuss role of trade in eradicating poverty
19 April 2021
An analysis of least-developed countries’ (LDCs) trade flows in 2020, presented to WTO members at a meeting of the Sub-Committee on LDCs on 19 April, revealed that the negative impact of the COVID-19 pandemic on trade was worse for LDCs than for the world as a whole. In addition, delegations discussed preparations for the Fifth United Nations Conference on LDCs as well as the latest research on LDCs carried out by the United Nations Conference on Trade and Development (UNCTAD)…
Introduced by UNCTAD, “The least-developed countries report 2020 — productive capacities for the new decade” notes that LDCs were innovative in setting up measures to combat the crisis, both productive and institutional. For example, Senegal came up with rapid COVID-19 testing facilities and Bangladesh revamped its manufacturing production capacity.
Yet, it is estimated that over 300 million people are still living in extreme poverty, according to UNCTAD. The organization’s new productive capacities index indicates that LDCs lag behind other developing countries in several productive capacity areas. The transition to a digital economy remains pending. This is due to costly adoption of new technological capabilities, to insufficient skills and inadequate infrastructure. Policies are needed to develop LDCs’ productive capacities through investment and industrial transition…

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 24 Apr 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Press Releases
No new digest content identified.

 

BIO [to 24 Apr 2021]
https://www.bio.org/press-releases
Press Releases
Proposed “TRIPS” Waiver Is the WRONG Way To Attack Global Access for Vaccines to Developing Countries
April 20, 2021
Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), yesterday sent a letter to U.S. Trade Representative (USTR) Ambassador Katherine Tai sharing BIO perspectives regarding the proposed WTO “TRIPS waiver”…

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 24 Apr 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 24 Apr 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 24 Apr 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
ACT-Accelerator 1-Year Anniversary: the biopharmaceutical industry is committed to continue to play a critical role
23 April 2021
[See COVAX above for detail]

COVID-19 vaccine industry cautions immediate action needed to remove manufacturing supply barriers to meet production
23 April 2021
[See COVAX above for detail]

 

PhRMA [to 24 Apr 2021]
http://www.phrma.org/
Selected Press Releases, Statements
Data shows that Americans are relying on vaccines to get us through the pandemic
April 22, 2021
Data shows that Americans are relying on vaccines to get us through the pandemic.
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

Assessment of the All of Us research program’s informed consent process

AJOB Empirical Bioethics
Volume 12, 2020 Issue 2
https://www.tandfonline.com/toc/uabr21/current

 

Article
Assessment of the All of Us research program’s informed consent process
Megan Doerr, Sarah Moore, Vanessa Barone, Scott Sutherland, Brian M. Bot, Christine Suver & John Wilbankson behalf of the All of Us Consent Working Group* and the Low Health Literacy Consent Study Research Team*
Published online: 04 Dec 2020
Abstract
Informed consent is the gateway to research participation. We report on the results of the formative evaluation that follows the electronic informed consent process for the All of Us Research Program. Of the nearly 250,000 participants included in this analysis, more than 95% could correctly answer questions distinguishing the program from medical care, the voluntary nature of participation, and the right to withdraw; comparatively, participants were less sure of privacy risk of the program. We also report on a small mixed-methods study of the experience of persons of very low health literacy with All of Us informed consent materials. Of note, many of the words commonly employed in the consent process were unfamiliar to or differently defined by informants. In combination, these analyses may inform participant-centered development and highlight areas for refinement of informed consent materials for the All of Us Research Program and similar studies.

Compassionate Force

AMA Journal of Ethics
Volume 23, Number 3 Apr 2021
https://journalofethics.ama-assn.org/issue/compassionate-force

 

Compassionate Force
Using force in caregiving is most often justified based on risk-benefit or best interest analyses. Careful, inclusive deliberation about whether force should be used in the course of a patient’s care is a rise-to-the minimum precursor of responsible force implementation, as is minimizing a patient’s risk of harm. Even when clinically indicated and ethically justifiable, force protocols drawing on physical, pharmaceutical, and legal means of restraint or seclusion can undermine therapeutic capacity in patient-clinician relationships, erode trust, and exacerbate emotional and moral distress for both patients and clinicians. These high stakes cum patients’ extreme vulnerability prompt us to consider how clinicians’ and organizations’ clinical and ethical obligations extend beyond harm minimization to compassion maximization. Although the words “compassion” and “force” rarely appear together, this issue investigates what their union could mean for and make possible in the enterprise of health care.

Contact Tracing and the COVID-19 Response in Africa: Best Practices, Key Challenges, and Lessons Learned from Nigeria, Rwanda, South Africa, and Uganda

American Journal of Tropical Medicine and Hygiene
Volume 104 (2021): Issue 4 (Apr 2021)
https://www.ajtmh.org/view/journals/tpmd/104/4/tpmd.104.issue-4.xml

 

Contact Tracing and the COVID-19 Response in Africa: Best Practices, Key Challenges, and Lessons Learned from Nigeria, Rwanda, South Africa, and Uganda
Jean B. Nachega, Rhoda Atteh, Chikwe Ihekweazu, Nadia A. Sam-Agudu, Prisca Adejumo, Sabin Nsanzimana, Edson Rwagasore, Jeanine Condo, Masudah Paleker, Hassan Mahomed, Fatima Suleman, Alex Riolexus Ario, Elsie Kiguli-Malwadde, Francis G. Omaswa, Nelson K. Sewankambo, Cecile Viboud, Michael J. A. Reid, Alimuddin Zumla, and Peter H. Kilmarx
DOI: https://doi.org/10.4269/ajtmh.21-0033

Hematological Abnormalities in COVID-19: A Narrative Review

American Journal of Tropical Medicine and Hygiene
Volume 104 (2021): Issue 4 (Apr 2021)
https://www.ajtmh.org/view/journals/tpmd/104/4/tpmd.104.issue-4.xml

 

Review Article
Open access
Hematological Abnormalities in COVID-19: A Narrative Review
Asma Rahman, Roshan Niloofa, Umesh Jayarajah, Sanjay De Mel, Visula Abeysuriya, and Suranjith L. Seneviratne
DOI: https://doi.org/10.4269/ajtmh.20-1536
ABSTRACT
COVID-19 is caused by SARS-CoV-2. Although pulmonary manifestations have been identified as the major symptoms, several hematological abnormalities have also been identified. This review summarizes the reported hematological abnormalities (changes in platelet, white blood cell, and hemoglobin, and coagulation/fibrinolytic alterations), explores their patho-mechanisms, and discusses its management. Common hematological abnormalities in COVID-19 are lymphopenia, thrombocytopenia, and elevated D-dimer levels. These alterations are significantly more common/prominent in patients with severe COVID-19 disease, and thus may serve as a possible biomarker for those needing hospitalization and intensive care unit care. Close attention needs to be paid to coagulation abnormalities, and steps should be taken to prevent these occurring or to mitigate their harmful effects. The effect of COVID-19 in patients with hematological abnormalities and recognized hematological drug toxicities of therapies for COVID-19 are also outlined.

A Realist Synthesis of Community-Based Interventions in Vector-Borne Diseases

American Journal of Tropical Medicine and Hygiene
Volume 104 (2021): Issue 4 (Apr 2021)
https://www.ajtmh.org/view/journals/tpmd/104/4/tpmd.104.issue-4.xml

 

A Realist Synthesis of Community-Based Interventions in Vector-Borne Diseases
Dennis Pérez, Emilie Robert, Elsury Johanna Pérez, Veerle Vanlerberghe, Pierre Lefèvre, and Valéry Ridde
DOI: https://doi.org/10.4269/ajtmh.20-0944
ABSTRACT
Randomized control trials have provided evidence that some community-based interventions (CBIs) work in vector-borne diseases (VBDs). Conversely, there is limited evidence on how well those CBIs succeed in producing specific outcomes in different contexts. To conduct a realist synthesis for knowledge translation on this topic, we examined the extent to which realist concepts (context, mechanisms, and outcomes) and their relationships are present in the existing literature on CBIs for VBDs. Articles on CBIs were identified from prior scoping reviews of health interventions for VBDs. Content of the articles was extracted verbatim if it referred either to realist concepts or CBI features. The number of articles and the average number of words extracted per category per CBI were quantified. Content of the articles was scrutinized to inductively gather qualitative evidence on the interactions between realist concepts. We reviewed 41 articles on 17 CBIs from 12 countries. The average number of words used for mechanisms was much lower than those used for outcomes and context (309,474, and 836, respectively). The average number of words used for mechanisms increased when a CBI was described in three or more articles. There were more extensive accounts on CBI features than on mechanisms. It was difficult to gather evidence on the interactions among realist concepts from the content of the articles. Scarce reporting on mechanisms in published articles limits conducting a realist synthesis of CBIs in VBDs. More transdisciplinary research that goes beyond the biomedical paradigm is needed to boost the development of intervention mechanisms in this field.

Refugee Settlements and Cholera Risks in Uganda, 2016–2019

American Journal of Tropical Medicine and Hygiene
Volume 104 (2021): Issue 4 (Apr 2021)
https://www.ajtmh.org/view/journals/tpmd/104/4/tpmd.104.issue-4.xml

 

Articles
Refugee Settlements and Cholera Risks in Uganda, 2016–2019
Godfrey Bwire, Christopher Garimoi Orach, Freda Loy Aceng, Sam Emmanuel Arianitwe, David Matseketse, Edson Tumusherure, Issa Makumbi, Allan Muruta, Rebecca D. Merrill, Amanda Debes, Mohammad Ali, and David A. Sack
DOI: https://doi.org/10.4269/ajtmh.20-0741

A Comprehensive Policy Framework to Understand and Address Disparities and Discrimination in Health and Health Care: A Policy Paper From the American College of Physicians

Annals of Internal Medicine
April 2021 Volume 174, Issue 4
http://annals.org/aim/issue

 

Position Papers
A Comprehensive Policy Framework to Understand and Address Disparities and Discrimination in Health and Health Care: A Policy Paper From the American College of Physicians
FREE
Josh Serchen, BA, Robert Doherty, BA, Omar Atiq, MD, David Hilden, MD, MPH, … et al.
Pages:529–532

Advancing the ethical dialogue about monkey/human chimeric embryos

Cell
Apr 15, 2021 Volume 184 Issue 8 p1941-2258
https://www.cell.com/cell/current

 

Previews
Advancing the ethical dialogue about monkey/human chimeric embryos
Henry T. Greely, Nita A. Farahany
In this issue of Cell, Tan et al. report the first injection of human stem cells into in vitro non-human primate blastocysts with significant survival of the human cells, raising new scientific possibilities but also important ethical issues.

Chimeric contribution of human extended pluripotent stem cells to monkey embryos ex vivo

Cell
Apr 15, 2021 Volume 184 Issue 8 p1941-2258
https://www.cell.com/cell/current

 

Article
Chimeric contribution of human extended pluripotent stem cells to monkey embryos ex vivo
Tao Tan, et a;
Human cells, in the form of extended pluripotent stem cells, have the ability to contribute to both embryonic and extra-embryonic lineages in ex-vivo-cultured monkey embryos.

Toward a fine-scale population health monitoring system

Cell
Apr 15, 2021 Volume 184 Issue 8 p1941-2258
https://www.cell.com/cell/current

 

Featured Article
Toward a fine-scale population health monitoring system
Gillian M. Belbin, et al
Taking a quantitative approach to genetic ancestry in health systems furthers understanding of disease burdens specific to fine-scale populations and the environmental and demographic ties that can impact disease.

Antenatal care providers’ attitudes and beliefs towards maternal vaccination in Kenya

Gates Open Research
https://gatesopenresearch.org/browse/articles
[Accessed 24 Apr 2021]

 

Research Article metrics
Revised
Antenatal care providers’ attitudes and beliefs towards maternal vaccination in Kenya [version 2; peer review: 1 approved, 1 not approved]
Subhash Chander, Ines Gonzalez-Casanova, Sandra S. Chaves, Nancy A. Otieno, Marc-Alain Widdowson, Jennifer Verani, Paula Frew, Andrew Wilson, Saad B. Omer, Fauzia Malik
Peer Reviewers Clarissa Simas; Zhihua Liu
Funder: Bill and Melinda Gates Foundation
LATEST VERSION PUBLISHED 22 Apr 2021

The impact of genomics on precision public health: beyond the pandemic

Genome Medicine
https://genomemedicine.biomedcentral.com/articles
[Accessed 24 Apr 2021]

 

Articles
The impact of genomics on precision public health: beyond the pandemic
Authors: Muin J. Khoury and Kathryn E. Holt
Citation: Genome Medicine 2021 13:67
Content type: Editorial
Published on: 23 April 2021
Precision public health has been defined in many ways [1]. It can be viewed as an emerging multidisciplinary field that uses genomics, big data, and machine learning/artificial intelligence to predict health risks and outcomes and to improve health at the population level. Just like precision medicine seeks to provide the right intervention to the right patient at the right time, the aim of precision public health is to provide the right intervention to the right population at the right time, with the goal of improving health for all.

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.

The estimated impact of decreased childhood vaccination due to COVID-19 using a dynamic transmission model of mumps in Japan

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 17, Issue 5, 2021
https://www.tandfonline.com/toc/khvi20/current

 

Article
The estimated impact of decreased childhood vaccination due to COVID-19 using a dynamic transmission model of mumps in Japan
Taito Kitano & Hirosato Aoki
Pages: 1313-1316
Published online: 29 Oct 2020

Real-world evidence of quadrivalent meningococcal conjugate vaccine safety in the United States: a systematic review

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 17, Issue 5, 2021
https://www.tandfonline.com/toc/khvi20/current

 

Review
Real-world evidence of quadrivalent meningococcal conjugate vaccine safety in the United States: a systematic review
Tracy a Becerra-Culqui, Lina S. Sy, Zendi Solano & Hung Fu Tseng
Pages: 1432-1441
Published online: 17 Dec 2020

Determinants of policy and uptake of national vaccine programs for pregnant women: results of mixed method study from Spain, Italy, and India

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 17, Issue 5, 2021
https://www.tandfonline.com/toc/khvi20/current

 

Article
Determinants of policy and uptake of national vaccine programs for pregnant women: results of mixed method study from Spain, Italy, and India
Lois Privor-Dumm
Pages: 1474-1482
Published online: 20 Nov 2020

Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19

JAMA
April 20, 2021, Vol 325, No. 15, Pages 1489-1575
https://jamanetwork.com/journals/jama/currentissue

 

Original Investigation
Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19
Kathryn E. Stephenson, MD, MPH; Mathieu Le Gars, PhD; Jerald Sadoff, MD; et al.
free access has active quiz
JAMA. 2021;325(15):1535-1544. doi:10.1001/jama.2021.3645
This randomized trial compares the immunogenicity of a SARS-CoV-2 Ad26.COV2.S vaccine at high vs low vs no dose (placebo) in humans, including the kinetics, magnitude, and phenotype of coronavirus spike-specific humoral and cellular immune responses.

Acute Allergic Reactions to mRNA COVID-19 Vaccines

JAMA
April 20, 2021, Vol 325, No. 15, Pages 1489-1575
https://jamanetwork.com/journals/jama/currentissue

 

Research Letter
Acute Allergic Reactions to mRNA COVID-19 Vaccines
Kimberly G. Blumenthal, MD, MSc; Lacey B. Robinson, MD, MPH; Carlos A. Camargo Jr, MD, DrPH; et al.
free access has active quiz
JAMA. 2021;325(15):1562-1565. doi:10.1001/jama.2021.3976
This study examines the incidence of acute allergic reactions to mRNA COVID-19 vaccine administrations in health care employees in Massachusetts.

CDC Interim Recommendations for Fully Vaccinated People An Important First Step

JAMA
April 20, 2021, Vol 325, No. 15, Pages 1489-1575
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
CDC Interim Recommendations for Fully Vaccinated People An Important First Step
Athalia Christie, MIA; Sarah A. Mbaeyi, MD; Rochelle P. Walensky, MD
free access has active quiz
JAMA. 2021;325(15):1501-1502. doi:10.1001/jama.2021.4367
This Viewpoint summarizes CDC activity recommendations for individuals fully vaccinated against SARS-CoV-2 infection, including resumption of low-risk gatherings among vaccinated people and maintenance of public health measures in activities involving unvaccinated people.

Incentivizing Vaccination Uptake – The “Green Pass” Proposal in Israel

JAMA
April 20, 2021, Vol 325, No. 15, Pages 1489-1575
https://jamanetwork.com/journals/jama/currentissue

 

Incentivizing Vaccination Uptake – The “Green Pass” Proposal in Israel
Rachel Wilf-Miron, MD, MPH; Vicki Myers, PhD; Mor Saban, PhD
free access has active quiz
JAMA. 2021;325(15):1503-1504. doi:10.1001/jama.2021.4300
This Viewpoint explains the “green pass” program in Israel to encourage residents to seek COVID-19 vaccination, with incentives including access to social, cultural, and sports events and gyms, hotels, and restaurants as well as exemption from quarantine after travel or exposure to an individual with SARS-CoV-2 infection.

COVID-19 Vaccination of Adolescents and Young Adults of Color: Viewing Acceptance and Uptake With a Health Equity Lens

Journal of Adolescent Health
Volume 68 Issue 5 p833-1024
https://www.jahonline.org/current

 

Commentary
COVID-19 Vaccination of Adolescents and Young Adults of Color: Viewing Acceptance and Uptake With a Health Equity Lens
Tamera Coyne-Beasley, Samantha V. Hill, Gregory Zimet,…Maria Veronica Svetaz, Maria Trent, Leslie Walker-Harding
Published online: April 01, 2021
p844-846

2021: the beginning of a new era of immunisations?

The Lancet
Apr 24, 2021 Volume 397 Number 1028 4p1519-1596
https://www.thelancet.com/journals/lancet/issue/current

 

Editorial
2021: the beginning of a new era of immunisations?
The Lancet
While the world is firmly focused on the efficacy, adverse events, licensing, and roll-out of COVID-19 vaccines, the disruption of and barriers to routine immunisations during the pandemic have garnered much less attention. World Immunization Week (April 24–30) presents an opportunity to reflect on the state of immunisation efforts for vaccine-preventable diseases, how the COVID-19 pandemic has affected progress, and what lessons can accelerate efforts to prevent diseases through immunisation.

The Immunization Agenda 2030 (IA2030) will be officially launched on April 26. This agenda provides a new global vision and strategy for vaccines for the next decade, following on from the Global Vaccine Action Plan (2011–20). Before the beginning of the pandemic, progress in vaccine coverage had already been stalling between 2010 and 2019. For example, according to WHO and UNICEF data, global rates of immunisation with the first dose of measles-containing vaccine remained at 84–85%. The Global Vaccine Action Plan was important to bring partners together and broadened the vaccine coverage to include newer vaccines, such as those for rotavirus and hepatitis B. However, the conclusion of a WHO evaluation was that it did not make progress in addressing inequity and was only partly successful in influencing national actions as a top–down approach.

IA2030 sets out a very ambitious plan, taking lessons learnt into account and hoping that COVID-19 prevention provides a stark reminder of the importance and power of vaccines. The agenda, which was designed with the cooperation of countries, puts much more emphasis on an approach tailored to the national context and integrated into primary health-care services, particularly to prioritise populations that have not been reached. Immunisation at all ages should be part of such a national plan and will vary in national strategies according to demographics. The agenda aims to be adaptable to changing circumstances brought on by, for example, increased migration, civil unrest, climate change, or future pandemics, but the specifics on how such resilience can be achieved are not established. The four overarching principles the IA2030 puts forward are a people-centred, country-owned, partnership-based, and data-guided approach.

Nobody would disagree with the agenda’s aims. It is laudable that previous shortcomings have been considered and health systems strengthening, especially at the primary care level, is seen as crucial for sustainable progress. The key to success, however, will be how to implement the national plans and to ensure financing is sustained. The COVID-19 pandemic has made this task much more difficult by severely disrupting routine immunisation. Because of travel restrictions, deployment of scarce health workers to COVID-19 care, shortage of personal protective equipment, and disruption of supply chains, many countries will have to provide catch-up services and risk severe outbreaks of vaccine-preventable diseases when easing lockdown. Interruptions in survey data collection will mean data gaps will make it harder to identify those most in need. COVID-19 has further exacerbated inequities and poverty and has led to mass migration from urban to rural areas in many countries, making it difficult to keep track of people needing vaccinations.

But COVID-19 has also catalysed new approaches to vaccine development and mass vaccination efforts that could be taken forward in national routine immunisation plans and vaccine development more generally. For example, house-to-house COVID-19 vaccinations, as offered in some high-income countries to vaccinate individuals shielding or unable to travel, might reach those otherwise missed. Short-term vaccination centres could be used, and school-based or work-based vaccinations could be offered. Electronic immunisation registries should be rolled out widely to facilitate data collection and identification of gaps with attention to data protection and security. Accelerating vaccine development, testing in trials, and licensing with robust post-licensing surveillance should become the new norm. Techniques used for COVID-19 vaccines, such as the use of mRNA, might be applicable to other diseases. Early-phase research for mRNA and vector-based vaccines for HIV has started.

Much has been achieved through vaccination, with many lives saved and disabilities prevented. Science has brought us options for many diseases, with further possibilities on the horizon. A new era of immunisations is much needed and the IA2030 sets out a very good framework. But vaccine hesitancy remains an important issue to tackle. And without addressing the fundamental underlying barriers of inequity, poverty, political posturing, and commercial interest protection, the next decade will not achieve much more than the past.

Human rights and fair access to COVID-19 vaccines: the International AIDS Society–Lancet Commission on Health and Human Rights

The Lancet
Apr 24, 2021 Volume 397 Number 1028 4p1519-1596
https://www.thelancet.com/journals/lancet/issue/current

 

Comment
Human rights and fair access to COVID-19 vaccines: the International AIDS Society–Lancet Commission on Health and Human Rights
Commissioners of and collaborators with the International AIDS Society–Lancet Commission on Health and Human Rights
… The Commission had its first meeting in early 2021 and expects to produce its first full report in 2022. The key questions that will inform our work are shown in the panel. We are charged with examining how to ensure that human rights are at the core of global health efforts, enabling them to fulfil the lofty goals outlined in the WHO Constitution, in international human rights treaties, and in many national constitutions and legal frameworks: that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction and that the health of all peoples is fundamental to the attainment of peace and security and is dependent on the fullest cooperation of individuals and states.23
The Commission’s work will seek to strengthen and expand health and human rights efforts to include emerging areas that impact the right to health, including misinformation, disinformation, social media, and the politicisation of health information; the climate crisis and the right to a sustainable environment; and the social determinants of health arising from inequity, social injustice, and conflict and displacement.
Framing questions the Commission will interrogate
1. What is the future of the health and human rights framework?
2. How can the health and human rights framework be revitalised and reinvigorated to achieve healthy communities?
3. What domains of the health and human rights framework are most relevant for ensuring robust health systems and universal access to prevention and care?

The escalating tuberculosis crisis in central and South American prisons

The Lancet
Apr 24, 2021 Volume 397 Number 1028 4p1519-1596
https://www.thelancet.com/journals/lancet/issue/current

 

Health Policy
The escalating tuberculosis crisis in central and South American prisons
Katharine S Walter, et al
Summary
In the past decade, tuberculosis incidence has declined in much of the world, but has risen in central and South America. It is not yet clear what is driving this reversal of progress in tuberculosis control. Since 2000, the incarcerated population in central and South America has grown by 206%, the greatest increase in the world. Over the same period, notified tuberculosis cases among the incarcerated population (hereinafter termed persons deprived of their liberty [PDL], following the Inter-American Commission on Human Rights) have risen by 269%. In both central and South America, the rise of disease among PDL more than offsets tuberculosis control gains in the general population. Tuberculosis is increasingly concentrated among PDL; currently, 11% of all notified tuberculosis cases in central and South America occur among PDL who comprise less than 1% of the population. The extraordinarily high risk of acquiring tuberculosis within prisons creates a health and human rights crisis for PDL that also undermines wider tuberculosis control efforts. Controlling tuberculosis in this region will require countries to take urgent measures to prioritise the health of PDL.