WHO & Regional Offices [to 16 May 2020]

WHO & Regional Offices [to 16 May 2020]
News release
WHO and Costa Rica preview technology pooling initiative to ensure access to COVID-19 health products for all
Geneva, 15 May 2020 – Presidents Carlos Alvarado Quesada of Costa Rica and Sebastián Piñera of Chile joined WHO Director-General Dr Tedros Adhanom Ghebreyesus today to announce progress on a technology platform that aims to lift access barriers to effective vaccines, medicines and other health products against COVID-19. Costa Rica proposed the idea at the beginning of the COVID-19 outbreak and several countries are now backing the proposal.
“Our proposal relies on solidarity,” said President Alvarado of Costa Rica. “It’s a Solidarity call to action to Member States, to academia, to companies, research institutions and cooperation agencies, based on global social responsibility, on a voluntary basis, promoting more global nonexclusive voluntary licensing.”
“We need to unleash the full power of science, without caveats or restrictions, to deliver innovations that are scalable, usable, and benefit everyone, everywhere, at the same time,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus…

14 May 2020 News release
Substantial investment needed to avert mental health crisis

13 May 2020 News release
WHO: People living longer and healthier lives but COVID-19 threatens to throw progress off track

13 May 2020 News release
Launch of the WHO Academy and the WHO Info mobile applications

11 May 2020 News release
ECOSOC Informal Briefing on ‘Joining Forces: Effective Policy Solutions for Covid-19 Response’

 

::::::

Weekly Epidemiological Record, 15 May 2020, vol. 95, 20 (pp. 209–228)
Dracunculiasis eradication: global surveillance summary, 2019

 

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: COVID-19 could deepen food insecurity, malnutrition in Africa 14 May 2020
:: Nigeria drives routine immunization amid COVID-19 14 May 2020
:: Ghana bolsters medicines regulatory system, guarantees product quality 13 May 2020

WHO Region of the Americas PAHO
No new digest content identified.

WHO South-East Asia Region SEARO
:: Local epidemiology should guide focused action in ‘new normal’ COVID-19 world 15 May 2020

WHO European Region EURO
:: COVID-19: WHO joins forces with young Global Shapers to disseminate health advice 15-05-2020
:: Behavioural insights are valuable to inform the planning of appropriate pandemic response measures 14-05-2020
:: Polish medics bring Italian COVID-19 experience to Kyrgyzstan with WHO support 13-05-2020
:: Bulgaria launches new national programme amid pandemic on violence against women and children 13-05-2020
:: New WHO resource on enhancing competencies of primary care nurses 12-05-2020

WHO Eastern Mediterranean Region EMRO
:: Yemen faces unprecedented risk as COVID-19 starts to spread 13 May 2020
:: WHO supports accelerated response efforts for contact tracing in Somalia 11 May 2020
:: Migrants face COVID-19 discrimination in Yemen 10 May 2020

WHO Western Pacific Region
No new digest content identified.

CDC/ACIP [to 16 May 2020]

CDC/ACIP [to 16 May 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases
Media Statement from Dr. Robert Redfield, CDC Director; Dr. Steve Hahn, FDA Commissioner; and Dr. Anthony Fauci, NIAID Director Tuesday, May 12, 2020
The Centers for Disease Control and Prevention (CDC) and the U.S. Department of Homeland Security (DHS) have together determined that government entities working in support of the COVID-19 response efforts are providing essential services and the current guidelines for critical infrastructure workers apply. Therefore, providing that they are asymptomatic, screened, and monitored for fever and other symptoms, wear a face covering, and maintain a distance of at least six feet from others, Drs. Redfield, Hahn, and Fauci can and will participate in meetings on the White House complex when their attendance is needed.

MMWR News Synopsis Friday, May 15, 2020
Survival and HIV-Free Survival Among Children Aged ≤3 Years — Eight Sub-Saharan African Countries, 2015–2017

COVID-19 in Correctional and Detention Facilities — United States, February–April 2020 (Early release May 6, 2020)

Effects of the COVID-19 Pandemic on Routine Pediatric Vaccine Ordering and Administration — United States, 2020 (Early release May 8, 2020)

Public Health Response to COVID-19 Cases in Correctional and Detention Facilities — Louisiana, March–April 2020 (Early release May 8, 2020)

Identification and Monitoring of International Travelers During the Initial Phase of an Outbreak of COVID-19 — California, February 3–March 17, 2020 (Early release May 11, 2020)

Preliminary Estimate of Excess Mortality During the COVID-19 Outbreak — New York City, March 11–May 2, 2020 (Early release May 11, 2020)

High SARS-CoV-2 Attack Rate Following Exposure at a Choir Practice — Skagit County, Washington, March 2020 (Early release May 12, 2020)

China CDC

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

 

National Health Commission of the People’s Republic of China
http://en.nhc.gov.cn/
News
May 16: Daily briefing on novel coronavirus cases in China
2020-05-16

Xi calls for vigilance to combat virus
2020-05-15

Chinese mainland’s asymptomatic COVID-19 cases drop in past 10 days: official
2020-05-15

5 vaccines in China set to finish phase 2 trials in July
2020-05-15
China now has five vaccines, one vector and four inactivated, that have entered the first two phases of clinical trials in China, a senior scientist said on May 15. Vaccine recipients in phase II trials have reported no major adverse effects, and these vaccines are set to complete their phase II trials in July.
“As of today, vaccine development is generally progressing smoothly,” Zeng Yixin, deputy director of the National Health Commission, said in a news briefing on Friday.
Zeng said some vaccine candidates are conducting phase I and II clinical trials concurrently in China, which is considered “an innovation” in the emergency approval mechanism of the National Medical Products Administration.
Right now, 2,575 volunteers in total have been administered the five vaccines, including 539 volunteers for phase I trials, Zeng said. “We have gained preliminary data for phase I trials on the vaccines’ safety and ability to create protective antibodies.”
The phase II trials, which enrolled 2,036 volunteers, aim to further evaluate the vaccines’ safety and potency. “Some volunteers are taking more than one dose now, and relevant research is ongoing,” he said.
“We have not recorded any major adverse effects for volunteers in these trials,” he said. “If everything goes according to plan, these projects would finish their phase II trial in July.”…

Best efforts made in early study of virus spread, says health authority
2020-05-15

Announcements

Announcements

 
 
Paul G. Allen Frontiers Group    [to 16 May 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.
 
 
BMGF – Gates Foundation  [to 16 May 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute    [to 16 May 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.
 
 
CARB-X   [to 16 May 2020]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
05.11.2020  |
CARB-X funds 60th project – $220M invested so far, plus millions more if milestones are met
CARB-X announced its 60th award today, representing more than $220 million invested since CARB-X was established in 2016 to support the early development of innovative products to fight drug resistance.
05.11.2020  |
CARB-X awards Day Zero Diagnostics $6.2M to develop a new test that would diagnose deadly superbug infections faster and determine what antibiotic would be most effective
CARB-X is awarding Day Zero Diagnostics, based in Boston, up to US$6.2 million in non-dilutive funding to develop a diagnostic system that could diagnose bacterial infections more quickly – within hours rather than days – and show physicians which antibiotics are most likely to effectively treat the infection. The innovative technology combines whole-genome sequencing and machine learning to identify the species of a pathogen and its drug-resistance profile without the need for culture, providing physicians with vital information to speed the appropriate treatment of serious drug-resistant bacterial infections in hours rather than days.
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 16 May 2020]
http://cepi.net/
Latest News
CEPI extends collaboration with Novavax to advance development and manufacture of COVID-19 vaccine
11 May 2020
 
 
Clinton Health Access Initiative, Inc. (CHAI)  [to 16 May 2020]
https://clintonhealthaccess.org/
News & Press Releases
No new digest content identified.
 
 
EDCTP    [to 16 May 2020]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
No new digest content identified.
 
 
Emory Vaccine Center    [to 16 May 2020]
http://www.vaccines.emory.edu/
[Undated]
No new digest content identified.
 
 
European Medicines Agency  [to 16 May 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
EU actions to support availability of medicines during COVID-19 pandemic – update #6
Press release 15/05/2020
The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual meeting on 13 May 2020. Participation to the meeting of the steering group was extended to all the heads of the national competent authorities (NCAs) of the EU Member States to discuss the measures taken by EU authorities to ensure the continued availability of medicines in Europe during the ongoing COVID-19 pandemic…

Press release: International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials
Last updated: 15/05/2020
[See Perspectives above for detail]
News: EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation
Last updated: 11/05/2020
 
 
European Vaccine Initiative  [to 16 May 2020]
http://www.euvaccine.eu/news-events
Latest News
No new digest content identified.
 
 
FDA [to 16 May 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
May 16, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests
The U.S. Food and Drug Administration has authorized an at-home sample collection kit that can then be sent to specified laboratories for COVID-19 diagnostic testing. Specifically, the FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit. Everlywell’s kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider…

May 15, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 15, 2020

May 14, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 14, 2020

May 14, 2020 – Coronavirus (COVID-19) Update: FDA Informs Public About Possible Accuracy Concerns with Abbott ID NOW Point-of-Care Test

Today, the U.S. Food and Drug Administration is alerting the public to early data that suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19. Specifically, the test may return false negative results.

“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue. We will continue to study the data available and are working with the company to create additional mechanisms for studying the test. This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health…

May 13, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 13, 2020

May 12, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 12, 2020

May 11, 2020 – Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19

Today, the U.S. Food and Drug Administration took important actions to help accelerate the development of prevention and treatment options for COVID-19 by providing new guidance with recommendations for innovators and researchers conducting work in this area. These guidance documents aim to make the process for submitting applications to initiate studies for new drugs and biological products more efficient and outline recommendations for ways to design clinical trials to evaluate safety and effectiveness of these medical products for COVID-19…
 
 
Fondation Merieux  [to 16 May 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.
 
 
 
Gavi [to 16 May 2020]
https://www.gavi.org/
News releases
12 May 2020
Canada commits CAD 600 million to Gavi
11 May 2020
Spain pledges new support to Gavi
 
 
GHIT Fund   [to 16 May 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.
 
 
 
Global Fund  [to 16 May 2020]
https://www.theglobalfund.org/en/news/
Sourcing & Management of Health Products
COVID-19 Diagnostics Procurement through the Global Fund
15 May 2020
News
Global Fund Board Members Unite to Fight
15 May 2020
Voices
On the Front Lines: Responding to COVID-19
15 May 2020
Voices
Amid COVID-19, Communities Continue Fight against Other Pandemics
12 May 2020
Voices
Protecting Mothers and Babies from HIV during the COVID-19 Pandemic
12 May 2020
 
 
Hilleman Laboratories   [to 16 May 2020]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 16 May 2020]
http://www.humanvaccinesproject.org/media/press-releases/
HVP COVID Report   May 13, 2020
Human Challenges to Accelerate SARS-CoV-2 Vaccine Development
By Stanley A. Plotkin, MD
Emeritus Professor of Pediatrics
University of Pennsylvania
Vaxconsult
 
 
IAVI  [to 16 May 2020]
https://www.iavi.org/newsroom
Press Releases
No new digest content identified.
 
 
International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
No new digest content identified.
 
 
International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
No new digest content identified.
 
 
IFFIm
http://www.iffim.org/
Press Releases
Norway Renews its Support for IFFIm with US$400 Million Pledge
08 May 2020
The 10-year commitment to support Gavi vaccine programmes is part of Norway’s US$ 1 billion commitment to Gavi London, 8 May 2020 – Norway has committed an additional US$ 400 million over the next 10 years to the International Finance Facility for Immunisation (IFFIm), which leverages long-term donor financing.
 
 
IFRC   [to 16 May 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
International Nurses Day: Nurses deserve praise, thanks, protection amid COVID-19
Geneva, 11 May 2020 – Nurses and other health care workers on the frontlines of the fight against COVID-19 deserve to be recognized and commended for their lifesaving efforts and personal sacrifices amid increased medical risk – and in some places amid …
11 May 2020
 
 
IVAC  [to 16 May 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
Commentary: The success of a Covid-19 vaccine will hinge on its delivery
May 2020
By Lois Privor-Dumm, Naor Bar Zeev, and Maria Deloria Knoll Originally published on STAT News
The lesson learned from a long history of using vaccines to fight massively disruptive diseases like smallpox and Ebola is that the vaccine itself is not enough. Like a good punch line, it’s all about the delivery. The smallpox vaccine […]
 
 
IVI   [to 16 May 2020]
http://www.ivi.int/
Selected IVI News & Announcements
No new digest content identified.
 
 
JEE Alliance  [to 16 May 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 16 May 2020]
http://www.msf.org/
Latest [Selected Announcements]
Sudan
MSF urges to respect medical action after violent incursion in Rokero, Centr…
Statement 15 May 2020

Coronavirus COVID-19 pandemic
COVID19 and lack of protective equipment threaten lifesaving care in KenyaProject Update 15 May 2020

Coronavirus COVID-19 pandemic
COVID-19 in West Africa: “Let’s prepare for a long-distance run”
Op-Ed 15 May 2020
Afghanistan
“They came to kill the mothers” in Kabul maternity hospital attack
Voices from the Field 14 May 2020
 
 
Afghanistan
Revolting attack on maternity ward kills pregnant women and babie…
Press Release 13 May 2020
 
 
Coronavirus COVID-19 pandemic
MSF supports the COVID-19 pandemic response in Guinea
Project Update 12 May 2020
 
 
National Vaccine Program Office – U.S. HHS  [to 16 May 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC 2020 Meetings
June 9-10, 2020 NVAC Meeting
September 23-24, 2020 Meeting (Virtual)
 
 
NIH  [to 16 May 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
Investigational ChAdOx1 nCoV-19 vaccine protects monkeys against COVID-19 pneumonia
May 15, 2020 — Study provided data for clinical testing to commence.
NIH begins clinical trial of hydroxychloroquine and azithromycin to treat COVID-19
May 14, 2020 — Study enrolling adults with mild to moderate COVID-19 in the United States.
Coordinated strategy to accelerate multiple COVID-19 vaccine candidates is key, NIH experts say
May 11, 2020 — More than one effective vaccine approach likely will be required to successfully protect the global community from SARS-CoV-2.
[See Milestones above for detail]
 
 
PATH  [to 16 May 2020]
https://www.path.org/media-center/
Selected Announcements
No new digest content identified.
 
 
Sabin Vaccine Institute  [to 16 May 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
BARDA Provides the Sabin Vaccine Institute with an Additional $20 Million for Further Development of Ebola Sudan and Marburg Vaccines
Wednesday, May 13, 2020
Sabin and Partner ReiThera Initiate Manufacturing of Clinical Trial Material
WASHINGTON, D.C. and ROME, Italy, May 13, 2020 – The Sabin Vaccine Institute (Sabin) and its partner ReiThera Srl today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, has exercised the first two options, valued at $20 million, under the 2019 contract to advance the development of vaccines against Ebola Sudan and Marburg viruses through Phase 2 clinical trials…
 
 
UNAIDS [to 16 May 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
16 May 2020
New videos highlight LGBTI issues in Brazil
14 May 2020
Let transgender people be in the picture
14 May 2020
Russian regional AIDS centres leading the fight against COVID-19
14 May 2020
Uniting behind a people’s vaccine against COVID-19
[See Milestones above for detail]
13 May 2020
COVID-19 in prisons—a ticking time bomb
13 May 2020
“We are human, so of course it was scary”
13 May 2020
Sex workers in Bangladesh: building resilience during the COVID-19 pandemic
12 May 2020
People with disabilities often left behind by HIV responses
12 May 2020
United Nations agencies coordinate their COVID-19 response in South Africa
11 May 2020
Dealing with COVID-19 in Cameroon
11 May 2020
HIV testing and support for homeless people in Belarus
 
 
UNICEF  [to 16 May 2020]
https://www.unicef.org/media/press-releases
Selected Press releases/Announcements
Press release
Geneva Palais briefing note on UNICEF response to COVID-19 in Rohingya refugee camps as first coronavirus case confirmed
15/05/2020
Press release
Declining vaccination rates in the Democratic Republic of the Congo could lead to resurgence in deadly diseases
KINSHASA/GENEVA/NEW YORK, 15 May 2020 –The reduction in vaccination rates currently being reported in the Democratic Republic of the Congo (DRC) will leave children in the country at increased risk of contracting deadly diseases such as polio, measles and yellow fever, UNICEF warned today.
The decline in the first two months of the year was likely due to established challenges such as poor cold chain systems, low coverage and stock supply. However, the DRC’s Expanded Programme on Immunization (EPI) is now facing a new challenge which will almost certainly worsen the situation: COVID-19. Health workers conducting routine vaccinations do not have access to adequate equipment to protect themselves, caregivers and children from the coronavirus. Parents are reluctant to attend vaccination sessions for fear of exposing themselves and their children to COVID-19…
Statement
Joint statement on Libya
by OCHA, UNHCR, UNICEF, UNFPA, WFP, WHO, IOM
13/05/2020
Press release
Forced returns of migrants must be suspended in times of COVID-19
Statement by the United Nations Network on Migration
GENEVA, 14 May 2020 – The United Nations Network on Migration is concerned by reports of States in many regions using forced return of migrants as a measure in response to COVID-19.    The Network calls on States to suspend forced returns during the pandemic, in order to protect the health of migrants and communities, and uphold the human rights of all migrants, regardless of status. Successfully tackling the pandemic cannot be achieved without upholding human rights.
When temporary border closures and movement restrictions are deemed necessary to prevent the transmission of COVID-19, they must be implemented in a way that is non-discriminatory and proportionate to achieving the public health aim pursued. Such closures should incorporate health protocols and processes to guarantee fundamental rights at all times.
Keeping everyone safe means ensuring that no-one faces the risk of refoulement by being returned to places where their life, safety or human rights are threatened. It means that collective expulsions, such as arbitrary pushbacks of migrants and asylum-seekers at borders, must be halted; that protection needs must be individually assessed; and that the rule of law and due process must be observed. It also means prioritizing protection, including every child’s best interests. These are obligations in international law that can never be put on hold and are vital to any successful approach to combatting COVID-19 for the benefit of all…
Press release
As COVID-19 devastates already fragile health systems, over 6,000 additional children under five could die a day, without urgent action
UNICEF launches #Reimagine, a global campaign to prevent the pandemic from becoming a lasting crisis for children
12/05/2020
Press release
UNICEF appeals for $1.6 billion to meet growing needs of children impacted by COVID-19 pandemic
New funding request is $1 billion more than March appeal, as countries reel from socioeconomic impact of COVID-19
11/05/2020
Statement
In light of COVID-19 crisis, UN officials call for immediate release of all children in detention, including Palestinian children
Joint Press Statement from Jamie McGoldrick, Humanitarian Coordinator in the occupied Palestinian territory (oPt), Genevieve Boutin, UNICEF Special Representative in State of Palestine, and James Heenan, Head of the UN Human Rights Office in the oPt
 
 
Unitaid  [to 16 May 2020]
https://unitaid.org/
Featured News
14 May 2020 | Statements
Equitable global access to vaccines, treatments and diagnostics is key to tackling COVID-19 pandemic

Geneva – As governments, international organizations, pharmaceutical industry, academia and others focus their efforts on the COVID-19 coronavirus, it is clear that this global pandemic needs a global response. It is both a public health need and a moral duty to ensure that this response is grounded in solidarity to ensure that the vaccines, treatments and diagnostics being developed are accessible to all, everywhere and at the same time.

Heads of State and government, and the World Health Organization, have recognized and actively supported this need.

There is growing international backing for the proposal of the President of Costa Rica for voluntary pooling of knowledge, intellectual property and data necessary for COVID-19 detection, prevention, treatment and response. The pledging marathon co-hosted by the European Union and its partners on 4 May 2020 stressed the need for global development of innovative responses that are both universally available and affordable.

This political will is being translated into action through the Access to COVID-19 Tools (ACT) Accelerator. Unitaid is proud to be part of the partnership driving the work around development, manufacturing, procurement and deployment of treatments. Core to this work must be to find innovative solutions that are adapted and accessible to all, especially in low-resource settings…
 
 
Vaccination Acceptance Research Network (VARN)  [to 16 May 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.
 
 
Vaccine Confidence Project  [to 16 May 2020]
http://www.vaccineconfidence.org/
Latest News & Archive
Building trust, managing risk around vaccines: from trials to delivery
Course Dates: 20 – 23 July 2020
This 3.5-day course, developed by the Vaccine Confidence ProjectTM at LSHTM, will highlight the importance of maintaining and improving vaccine confidence and explore the diversity of concerns and perceptions about vaccines and how they have impacted vaccine uptake across multiple global settings.
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 16 May 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
 
 
Wellcome Trust  [to 16 May 2020]
https://wellcome.ac.uk/news
News | 14 May 2020
Julia Gillard appointed as next Chair of Wellcome
Julia Gillard, the former Prime Minister of Australia, has been appointed as the next Chair of Wellcome. She will will succeed Eliza Manningham-Buller, who is stepping down from the role in April 2021.

News | 12 May 2020
Wellcome Leap announces leadership team
Wellcome Leap, a not-for-profit organisation founded by Wellcome to accelerate innovations that benefit global health, will be led by Regina E. Dugan as CEO and Jay Flatley as Chair.
With initial funding of $300 million, Wellcome Leap will undertake bold, unconventional programmes and fund them at scale. These programmes will target complex human health challenges with the goal of achieving breakthrough scientific and technological solutions within a decade…
 
 
The Wistar Institute   [to 16 May 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.
 
 
WFPHA: World Federation of Public Health Associations  [to 16 May 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.
 
 
World Organisation for Animal Health (OIE)   [to 16 May 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

::::::
 
 
ARM [Alliance for Regenerative Medicine]  [to 16 May 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.
 
 
BIO    [to 16 May 2020]
https://www.bio.org/press-releases
Press Releases
Modernized Biotech Regulation Will Unleash Greater Innovation
May 14, 2020
The U.S. Department of Agriculture (USDA) released today a modernized, science-based regulatory system for plant biotechnology aimed at maintaining oversight while driving innovation. Now government and industry must do more to build an informed and…

BIO Appoints a Physician-Scientist as New President and CEO
May 14, 2020
Immunologist Michelle McMurry-Heath is Selected  for Her Global Leadership and Commitment to Innovation and Patients Former FDA Official Will Succeed Industry Leader Jim Greenwood  on June 1 as Leader of World’s Largest Biotechnology…
Dr. Moncef Slaoui “Excellent Choice” to Lead Operation Warp Speed
May 13, 2020
Following the announcement that Dr. Moncef Slaoui will lead the Trump Administration’s “Operation Warp Speed” initiative, BIO’s President and CEO, Jim Greenwood, issued the following statement:  “Dr. Moncef Slaoui is an excellent choice…
New Medicine Pipeline Tracker Illustrates Unprecedented Effort to Eradicate COVID-19
May 12, 2020
The Biotechnology Innovation Organization (BIO) today unveiled a first-of-its-kind, interactive tracker of the new treatments and vaccines in the COVID-19 pipeline. This online resource illustrates the unprecedented campaign being undertaken by…
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 16 May 2020]
http://www.dcvmn.org/
News
9 May 2020
DCVMN united with the EU at the Coronavirus Global Response international pledging event
Brussels, 04 May 2020 – Governments, global health organizations, and experienced partners joined hands…
 
 
IFPMA   [to 16 May 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
COVID-19 Biopharmaceutical Industry – Regulatory Guiding Principles
Published on: 14 May 2020
During these unprecedented times, it is essential that we all come together to contribute to the development of medicines and vaccines for treatment and prevention of COVID-19.

Many activities, undertaken by governments, national regulatory authorities (NRAs), academia, global health stakeholders and the biopharmaceutical industry, are helping to identify, research, develop and manufacture at scale these vital technologies under immense time pressure.

While resources are being committed to address the pandemic, other equally important efforts must continue for the benefit of patients globally beyond COVID-19. Access to existing medicines and vaccines for treatment and prevention of other conditions, like diabetes, cancer and measles, must continue. Clinical research into new options and treatments for serious and life-threatening diseases and unmet medical needs should be preserved.

Despite the huge impact caused by COVID-19, the R&D-based biopharmaceutical industry must maintain and indeed increase the supply of medicines and vaccines to the best of our ability to patients at a time when ‘normal’ production, supply chains and business operations are adversely impacted and massively challenged.

With a need for increased speed and a ‘new’ normal comes unprecedented pressure on biopharmaceutical manufacturing, which we are committed to meeting whilst not affecting patient safety and quality.

Therefore, we would like to reiterate our continued commitments to:
:: Working in partnership and collaboration with NRAs to define the best science-based regulatory strategies for ensuring the availability of COVID-19 medicines and vaccines – Implementing new principles (e.g. regulatory reliance and mutual recognition) and enhancing existing approaches for clinical research, pharmaceutical production and advancement of new COVID-19 medicines and vaccines are critical for global public health.

:: Progressing research into new treatments and prevention of other conditions – We are committed to adhering to the best principles for conducting clinical research and ensuring the continuation of ongoing clinical trials for promising, non-COVID-19 treatments.

:: Maintaining supply of medicines and vaccines – Enabling continuity of manufacturing and availability of product supply is imperative for public health. Globally integrated supply chains, which ensure quality, safety and innovative approaches for distribution across the health sector, may be critically impacted by operational disruptions. We work to find solutions that address potential bottlenecks and barriers thereby avoiding disruptions that could jeopardize access to treatments.

:: Ensuring all our medicines and vaccines continue to meet appropriate standards for quality and safety – Patient safety and product quality are key priorities for the biopharmaceutical industry and are intrinsic to what we do. We routinely engage with regulatory and standard-setting bodies in the development and implementation of guidelines for the quality and safety of medicines and vaccines. We also monitor the use of our medicines and vaccines with patients to safeguard and promote public health.
 
 
PhRMA    [to 16 May 2020]
http://www.phrma.org/
Selected Press Releases, Statements
No new digest content identified.
 
 
Industry Watch   [to 16 May 2020]
:: Pfizer Announces Positive Top-Line Results From Phase 3 Lot Consistency Study of 20-Valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naive Adults 18 Through 49 Years of Age
20-valent pneumococcal conjugate vaccine elicits consistent immune response across three different lots
May 14, 2020   NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced top-line results from a second Phase 3 study (NCT03828617), which described the safety and evaluated the consistency of immune responses elicited across three different lots of its 20-valent pneumococcal polysaccharide conjugate vaccine (20vPnC) candidate in adults 18 through 49 years of age not previously vaccinated against pneumococcal disease. Responses elicited by 20vPnC for all 20 serotypes were equivalent across all three lots, meeting the primary immunogenicity objective of the study. In this study the 20vPnC safety profile was similar to the Prevnar 13® (pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) control group. This clinical lot consistency study is expected to satisfy licensure requirements for manufacturing consistency by the U.S. Food and Drug Administration, and other countries’ regulatory agencies.
“We are excited by the progress of our adult development program for 20vPnC as this is the second phase 3 trial for this investigational vaccine for which we have positive topline data,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer…
 

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

The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application

Annals of Internal Medicine
5 May 2020 Volume 172, Issue 9
http://annals.org/aim/issue

 

Original Research
The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application
FREE
Stephen A. Lauer, MS, PhD, Kyra H. Grantz, BA, Qifang Bi, MHS, Forrest K. Jones, MPH, Qulu Zheng, MHS, … et al.
Using news reports and press releases from provinces, regions, and countries outside Wuhan, Hubei province, China, this analysis estimates the length of the incubation period of COVID-19 and its public health implications.

How Should U.S. Hospitals Prepare for Coronavirus Disease 2019 (COVID-19)?

Annals of Internal Medicine
5 May 2020 Volume 172, Issue 9
http://annals.org/aim/issue

How Should U.S. Hospitals Prepare for Coronavirus Disease 2019 (COVID-19)?
FREE

Vineet Chopra, MD, MSc, Eric Toner, MD, Richard Waldhorn, MD, and Laraine Washer, MD
Estimates suggest that COVID-19 will stress bed capacity, equipment, and health care personnel in U.S. hospitals in ways not previously experienced. How can health systems prepare to care for a large influx of patients with this disease?

Uptake and acceptability of human papillomavirus self-sampling in rural and remote aboriginal communities: evaluation of a nurse-led community engagement model

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 16 May 2020)

 

Uptake and acceptability of human papillomavirus self-sampling in rural and remote aboriginal communities: evaluation of a nurse-led community engagement model
Aboriginal women experience disproportionately higher rates of cervical cancer mortality yet are less likely to participate in screening for early detection. This study sought to determine whether a community-…
Authors: Tegan Dutton, Jo Marjoram, Shellie Burgess, Laurinne Montgomery, Anne Vail, Nichole Callan, Sunil Jacob, David Hawkes, Marion Saville and Jannine Bailey
Citation: BMC Health Services Research 2020 20:398
Content type: Research article
Published on: 11 May 2020

Prioritising access to pandemic influenza vaccine: a review of the ethics literature

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 16 May 2020)

 

Prioritising access to pandemic influenza vaccine: a review of the ethics literature
Authors: Jane H. Williams and Angus Dawson
Citation: BMC Medical Ethics 2020 21:40
Content type: Review
Published on: 14 May 2020
Abstract
Background
The world is threatened by future pandemics. Vaccines can play a key role in preventing harm, but there will inevitably be shortages because there is no possibility of advance stockpiling. We therefore need some method of prioritising access.
Main text
This paper reports a critical interpretative review of the published literature that discusses ethical arguments used to justify how we could prioritise vaccine during an influenza pandemic. We found that the focus of the literature was often on proposing different groups as priorities (e.g. those with pre-existing health conditions, the young, the old, health care workers etc.). Different reasons were often suggested as a means of justifying such priority groupings (e.g. appeal to best overall outcomes, fairness, belonging to a vulnerable or ‘at risk’ group etc.). We suggest that much of the literature, wrongly, assumes that we are able to plan priority groups prior to the time of a particular pandemic and development of a particular vaccine. We also point out the surprising absence of various issues from the literature (e.g. how vaccines fit within overall pandemic planning, a lack of specificity about place, issues of global justice etc.).
Conclusions
The literature proposes a wide range of ways to prioritise vaccines, focusing on different groups and ‘principles’. Any plan to use pandemic vaccine must provide justifications for its prioritisation. The focus of this review was influenza pandemic vaccines, but lessons can be learnt for future allocations of coronavirus vaccine, if one becomes available.

Assessing the epidemiological impact on cervical cancer of switching from 4-valent to 9-valent HPV vaccine within a gender-neutral vaccination programme in Switzerland

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 16 May 2020)

 

Assessing the epidemiological impact on cervical cancer of switching from 4-valent to 9-valent HPV vaccine within a gender-neutral vaccination programme in Switzerland
An infection with high-risk human papillomavirus (HPV) is the obligatory aetiological factor for the development of cervical cancer. In Switzerland, the prevention strategy for cervical cancer is based on prim…
Authors: André B. Kind, Andrew Pavelyev, Smita Kothari, Nadia El Mouaddin, Aurélie Schmidt, Edith Morais, Patrik Guggisberg and Florian Lienert
Citation: BMC Public Health 2020 20:671
Content type: Research article
Published on: 12 May 2020

Interventions to increase uptake of cervical screening in sub-Saharan Africa: a scoping review using the integrated behavioral model

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 16 May 2020)

 

Interventions to increase uptake of cervical screening in sub-Saharan Africa: a scoping review using the integrated behavioral model
Sub-Saharan Africa (SSA) experiences disproportionate burden of cervical cancer incidence and mortality due in part to low uptake of cervical screening, a strategy for prevention and down-staging of cervical c…
Authors: Breanne E. Lott, Mario J. Trejo, Christina Baum, D. Jean McClelland, Prajakta Adsul, Purnima Madhivanan, Scott Carvajal, Kacey Ernst and John Ehiri
Citation: BMC Public Health 2020 20:654
Content type: Research article
Published on: 11 May 2020

 Vaccination card availability and childhood immunization in Senegal

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 16 May 2020)

Vaccination card availability and childhood immunization in Senegal
The World Health Organization recommends recording vaccination status according to maternal recall in countries where administrative reporting systems are insufficiently reliable, as maternal recall in develop…

 

Grounding Value‐Based Drug Pricing in Population Health

Clinical Pharmacology & Therapeutics
Volume 107, Issue 6 Pages: 1263-1457 June 2020
https://ascpt.onlinelibrary.wiley.com/toc/15326535/2020/107/6

 

Perspectives
Grounding Value‐Based Drug Pricing in Population Health
Anna Kaltenboeck, Maura Calsyn, Geert W.J. Frederix, Justin Lowenthal, David Mitchell, Bruce Rector, Ameet Sarpatwari
Pages: 1290-1292
First Published:17 January 2020

Access to innovative medicines by pharma companies: Sustainable initiatives for global health or useful advertisement?

Global Public Health
Volume 15, 2020 Issue 6
http://www.tandfonline.com/toc/rgph20/current

 

Article
Access to innovative medicines by pharma companies: Sustainable initiatives for global health or useful advertisement?
Michele de Medeiros Rocha, Emmanuel Paiva de Andrade, Edna Ribeiro Alves, João Carlos Cândido & Marcello de Miranda Borio
Pages: 777-789
Published online: 18 Feb 2020
ABSTRACT
Research & Development on new medicines plays an important role in life and well-being, making pharmaceutical companies important players in global health. Accessibility and financing new medicines, however, poses challenges for governments and patients around the world. Due to pricing and aggressive patent policy issues, pharma companies started to adopt access to medicines as a strategy to not only improve their public image but also to increase their economic performance. More than a useful institutional advertisement to attract new business, initiatives to improve access to medicines must be socially responsible and sustainable. Using content analysis methodology from CSR reports, the present study evaluated how 44 global companies are positioning themselves regarding access, whether these initiatives are aligned to existing access programmes and whether the actions disclosed on behalf of access are sustainable. We have identified 13 major access to medicines approaches that were classified into intrinsic, potentially sustainable and robust actions. We concluded that companies overvalue the term access to medicine. This can generate initiatives focused on advertisements rather than long-term actions and highlights the need for clear global criteria for companies and programmes that want to effectively publicise access to medicines as a social responsibility strategy.

COVID-19 in Africa: care and protection for frontline healthcare workers

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 16 May 2020]

 

COVID-19 in Africa: care and protection for frontline healthcare workers
Authors: Matthew F. Chersich, Glenda Gray, Lee Fairlie, Quentin Eichbaum, Susannah Mayhew, Brian Allwood, Rene English, Fiona Scorgie, Stanley Luchters, Greg Simpson, Marjan Mosalman Haghighi, Minh Duc Pham and Helen Rees
Content type: Review
15 May 2020

Impact of international travel dynamics on domestic spread of 2019-nCoV in India: origin-based risk assessment in importation of infected travelers

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 16 May 2020]

 

Impact of international travel dynamics on domestic spread of 2019-nCoV in India: origin-based risk assessment in importation of infected travelers
Authors: Sachin S. Gunthe and Satya S. Patra
Content type: Commentary
12 May 2020

Exploring why global health needs are unmet by research efforts: the potential influences of geography, industry and publication incentives

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 16 May 2020]

 

Exploring why global health needs are unmet by research efforts: the potential influences of geography, industry and publication incentives
Authors: Alfredo Yegros-Yegros, Wouter van de Klippe, Maria Francisca Abad-Garcia and Ismael Rafols
Content type: Research
15 May 2020

Is Africa prepared for tackling the COVID-19 (SARS-CoV-2) epidemic. Lessons from past outbreaks, ongoing pan-African public health efforts, and implications for the future

International Journal of Infectious Diseases
April 2020 Volume 93, p1-388
https://www.ijidonline.com/issue/S1201-9712(20)X0003-8

 

Editorials
Is Africa prepared for tackling the COVID-19 (SARS-CoV-2) epidemic. Lessons from past outbreaks, ongoing pan-African public health efforts, and implications for the future
Nathan Kapata, Chikwe Ihekweazu, Francine Ntoumi, Tajudeen Raji, Pascalina Chanda-Kapata, Peter Mwaba, Victor Mukonka, Matthew Bates, John Tembo, Victor Corman, Sayoki Mfinanga, Danny Asogun, Linzy Elton, Liã Bárbara Arruda, Margaret J. Thomason, Leonard Mboera, Alexei Yavlinsky, Najmul Haider, David Simons, Lara Hollmann, Swaib A. Lule, Francisco Veas, Muzamil Mahdi Abdel Hamid, Osman Dar, Sarah Edwards, Francesco Vairo, Timothy D. McHugh, Christian Drosten, Richard Kock, Giuseppe Ippolito, Alimuddin Zumla
p233–236
Published online: February 28, 2020

Immune response to different types of hepatitis B vaccine booster doses 2–32 years after the primary immunization schedule and its influencing factors

International Journal of Infectious Diseases
April 2020 Volume 93, p1-388
https://www.ijidonline.com/issue/S1201-9712(20)X0003-8

 

Immune response to different types of hepatitis B vaccine booster doses 2–32 years after the primary immunization schedule and its influencing factors
Yu-Liang Zhao, Lu-Lu Pan, Zhi-Yong Hao, Fei Jin, Yan-Hong Zhang, Min-Jie Li, Xin-Jiang Zhang, Bi-Hua Han, Hai-Song Zhou, Tian-Li Ma, Feng Wang, Jing-Chen Ma, Li-Peng Shen, Qi Li
p62–67
Published online: January 28, 2020

Evaluation of the effectiveness of pneumococcal conjugate vaccine for children in Korea with high vaccine coverage using a propensity score matched national population cohort

International Journal of Infectious Diseases
April 2020 Volume 93, p1-388
https://www.ijidonline.com/issue/S1201-9712(20)X0003-8

 

Evaluation of the effectiveness of pneumococcal conjugate vaccine for children in Korea with high vaccine coverage using a propensity score matched national population cohort
Sangho Sohn, Kwan Hong, Byung Chul Chun
p146–150
Published online: January 23, 2020

Ethics Committee Reviews of Applications for Research Studies at 1 Hospital in China During the 2019 Novel Coronavirus Epidemic

JAMA
May 12, 2020, Vol 323, No. 18, Pages 1749-1862
https://jamanetwork.com/journals/jama/currentissue

 

Research Letter
Ethics Committee Reviews of Applications for Research Studies at 1 Hospital in China During the 2019 Novel Coronavirus Epidemic
Hui Zhang, MBBS; Fengmin Shao, MD, PhD; Jianqin Gu, MD, PhD; et al.
free access has active quiz
JAMA. 2020;323(18):1844-1846. doi:10.1001/jama.2020.4362
This study reviews research ethics committee applications for COVID-19–related research at a Chinese hospital in February 2020 to characterize study type, approval rate and review time, reason for revision or denial, and issues with informed consent.
…Results
Ethics review conferences, held once every month in nonepidemic periods, were held 4 times in 35 days. The mean time was 2.13 days from application submissions until an initial review decision was made. For applications that required modifications, the mean time was 1.81 days for the resubmission to be reviewed again.
Forty-one applications were reviewed, including interventional studies (n = 21); diagnostic studies (n = 7); observational studies (n = 10); and other types (n = 3). Six (14.6%) were approved; 4 (9.8%), rejected; and 31 (75.6%), referred for modification.
Of the 4 rejected applications, 2 were denied because 1 involved a new, unapproved interferon-alfa treatment and another involved traditional Chinese medicine with many potential adverse reactions, so the potential risks outweighed benefits. The other 2 studies were denied because the laboratory biosafety level was inadequate, which may have led to virus leakage.
Of the 31 applications that required modifications, the issues with the research proposals and informed consent forms are indicated in Table 1 and Table 2. The most frequent issues with proposals were lack of statistical basis for the sample size calculation and deficiencies in inclusion and exclusion criteria. The most frequent issues with informed consent forms were that patients were not informed of the risks and that compensation was unreasonable.

The COVID-19 Pandemic in the USA Clinical Update

JAMA
May 12, 2020, Vol 323, No. 18, Pages 1749-1862
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
The COVID-19 Pandemic in the USA Clinical Update
Saad B. Omer, MBBS, PhD; Preeti Malani, MD, MSJ; Carlos del Rio, MD
free access has active quiz has multimedia has audio
JAMA. 2020;323(18):1767-1768. doi:10.1001/jama.2020.5788
This Viewpoint provides a summary update of coronavirus disease 2019 (COVID-19) in the US, discussing case-fatality rates, interpretation of polymerase chain reaction test results, duration of immunity, reinfection, and more.
Audio Interview: Coronavirus (COVID-19) Update: Clinical Review

A Framework for Rationing Ventilators and Critical Care Beds During the COVID-19 Pandemic

JAMA
May 12, 2020, Vol 323, No. 18, Pages 1749-1862
https://jamanetwork.com/journals/jama/currentissue

 

A Framework for Rationing Ventilators and Critical Care Beds During the COVID-19 Pandemic
Douglas B. White, MD, MAS; Bernard Lo, MD
free access has active quiz has multimedia has audio
JAMA. 2020;323(18):1773-1774. doi:10.1001/jama.2020.5046
This Viewpoint describes a framework for rationing ventilators during the COVID-19 pandemic should intensive care units find themselves with more patients than they can care for, using a score-based system that incorporates patients’ likelihood of surviving to hospital discharge and beyond and their role in the public health response to the outbreak.
Audio Interview: Coronavirus (COVID-19) Update: Fairly Rationing ICU Care

Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19)A Review

JAMA
May 12, 2020, Vol 323, No. 18, Pages 1749-1862
https://jamanetwork.com/journals/jama/currentissue

 

Review
Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19)A Review
James M. Sanders, PhD, PharmD; Marguerite L. Monogue, PharmD; Tomasz Z. Jodlowski, PharmD; et al.
free access has active quiz
JAMA. 2020;323(18):1824-1836. doi:10.1001/jama.2020.6019
This narrative review summarizes what is currently known about how SARS-CoV-2 infects cells and causes disease as a basis for considering whether chloroquine, remdisivir and other antivirals, or other existing drugs might be effective treatment for coronavirus disease 2019 (COVID-19).

Current regulatory approaches for accessing potential COVID-19 therapies

Journal of Pharmaceutical Policy and Practice
https://joppp.biomedcentral.com/
[Accessed 16 May 2020]

 

Current regulatory approaches for accessing potential COVID-19 therapies
Authors: Vesa Halimi, Armond Daci, Simona Stojanovska, Irina Panovska-Stavridis, Milena Stevanovic, Venko Filipce and Aleksandra Grozdanova
Content type: Commentary
16 May 2020
Abstract
This commentary aims to elaborate challenges in the regulatory approaches for accessing and investigating COVID-19 potential therapies either with off-label use, compassionate use, emergency use or for clinical trials. Since no therapies have been formally approved and completely effective and safe to date, the best clinical choice is acquired only after consistent and fair communication and collaboration between licensed clinicians, researchers, regulatory authorities, manufacturers and patients.

Reviving the US CDC

The Lancet
May 16, 2020 Volume 395 Number 10236 p1521-1586, e83-e89
https://www.thelancet.com/journals/lancet/issue/current

 

Editorial
Reviving the US CDC
The Lancet
The COVID-19 pandemic continues to worsen in the USA with 1·3 million cases and an estimated death toll of 80 684 as of May 12. States that were initially the hardest hit, such as New York and New Jersey, have decelerated the rate of infections and deaths after the implementation of 2 months of lockdown. However, the emergence of new outbreaks in Minnesota, where the stay-at-home order is set to lift in mid-May, and Iowa, which did not enact any restrictions on movement or commerce, has prompted pointed new questions about the inconsistent and incoherent national response to the COVID-19 crisis.

The US Centers for Disease Control and Prevention (CDC), the flagship agency for the nation’s public health, has seen its role minimised and become an ineffective and nominal adviser in the response to contain the spread of the virus. The strained relationship between the CDC and the federal government was further laid bare when, according to The Washington Post, Deborah Birx, the head of the US COVID-19 Task Force and a former director of the CDC’s Global HIV/AIDS Division, cast doubt on the CDC’s COVID-19 mortality and case data by reportedly saying: “There is nothing from the CDC that I can trust”. This is an unhelpful statement, but also a shocking indictment of an agency that was once regarded as the gold standard for global disease detection and control. How did an agency that was the first point of contact for many national health authorities facing a public health threat become so ill-prepared to protect the public’s health?

In the decades following its founding in 1946, the CDC became a national pillar of public health and globally respected. It trained cadres of applied epidemiologists to be deployed in the USA and abroad. CDC scientists have helped to discover new viruses and develop accurate tests for them. CDC support was instrumental in helping WHO to eradicate smallpox. However, funding to the CDC for a long time has been subject to conservative politics that have increasingly eroded the agency’s ability to mount effective, evidence-based public health responses. In the 1980s, the Reagan administration resisted providing the sufficient budget that the CDC needed to fight the HIV/AIDS crisis. The George W Bush administration put restrictions on global and domestic HIV prevention and reproductive health programming.

The Trump administration further chipped away at the CDC’s capacity to combat infectious diseases. CDC staff in China were cut back with the last remaining CDC officer recalled home from the China CDC in July, 2019, leaving an intelligence vacuum when COVID-19 began to emerge. In a press conference on Feb 25, Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, warned US citizens to prepare for major disruptions to movement and everyday life. Messonnier subsequently no longer appeared at White House briefings on COVID-19. More recently, the Trump administration has questioned guidelines that the CDC has provided. These actions have undermined the CDC’s leadership and its work during the COVID-19 pandemic.

There is no doubt that the CDC has made mistakes, especially on testing in the early stages of the pandemic. The agency was so convinced that it had contained the virus that it retained control of all diagnostic testing for severe acute respiratory syndrome coronavirus 2, but this was followed by the admission on Feb 12 that the CDC had developed faulty test kits. The USA is still nowhere near able to provide the basic surveillance or laboratory testing infrastructure needed to combat the COVID-19 pandemic.

But punishing the agency by marginalising and hobbling it is not the solution. The Administration is obsessed with magic bullets—vaccines, new medicines, or a hope that the virus will simply disappear. But only a steadfast reliance on basic public health principles, like test, trace, and isolate, will see the emergency brought to an end, and this requires an effective national public health agency. The CDC needs a director who can provide leadership without the threat of being silenced and who has the technical capacity to lead today’s complicated effort.

The Trump administration’s further erosion of the CDC will harm global cooperation in science and public health, as it is trying to do by defunding WHO. A strong CDC is needed to respond to public health threats, both domestic and international, and to help prevent the next inevitable pandemic. Americans must put a president in the White House come January, 2021, who will understand that public health should not be guided by partisan politics.

What policy makers need to know about COVID-19 protective immunity

The Lancet
May 16, 2020 Volume 395 Number 10236 p1521-1586, e83-e89
https://www.thelancet.com/journals/lancet/issue/current

 

Comment
What policy makers need to know about COVID-19 protective immunity
Daniel M Altmann, Daniel C Douek, Rosemary J Boyton
… Most of the available COVID-19 serology data derive from people who have been hospitalised with severe infection.8,18 In this group, around 90% develop IgG antibodies within the first 2 weeks of symptomatic infection and this appearance coincides with disappearance of virus,18 supporting a causal relationship between these events. However, a key question concerns antibodies in non-hospitalised individuals who either have milder disease or no symptoms. Anecdotal results from community samples yield estimates of under 10% of tested “controls” developing specific IgG antibodies. We await larger seroprevalence datasets, but it seems likely that natural exposure during this pandemic might, in the short to medium term, not deliver the required level of herd immunity and there will be a substantial need for mass vaccination programmes…

Artificial intelligence and the future of global health

The Lancet
May 16, 2020 Volume 395 Number 10236 p1521-1586, e83-e89
https://www.thelancet.com/journals/lancet/issue/current

 

Review
Artificial intelligence and the future of global health
Nina Schwalbe, Brian Wahl
Summary
Concurrent advances in information technology infrastructure and mobile computing power in many low and middle-income countries (LMICs) have raised hopes that artificial intelligence (AI) might help to address challenges unique to the field of global health and accelerate achievement of the health-related sustainable development goals. A series of fundamental questions have been raised about AI-driven health interventions, and whether the tools, methods, and protections traditionally used to make ethical and evidence-based decisions about new technologies can be applied to AI. Deployment of AI has already begun for a broad range of health issues common to LMICs, with interventions focused primarily on communicable diseases, including tuberculosis and malaria. Types of AI vary, but most use some form of machine learning or signal processing. Several types of machine learning methods are frequently used together, as is machine learning with other approaches, most often signal processing. AI-driven health interventions fit into four categories relevant to global health researchers: (1) diagnosis, (2) patient morbidity or mortality risk assessment, (3) disease outbreak prediction and surveillance, and (4) health policy and planning. However, much of the AI-driven intervention research in global health does not describe ethical, regulatory, or practical considerations required for widespread use or deployment at scale. Despite the field remaining nascent, AI-driven health interventions could lead to improved health outcomes in LMICs. Although some challenges of developing and deploying these interventions might not be unique to these settings, the global health community will need to work quickly to establish guidelines for development, testing, and use, and develop a user-driven research agenda to facilitate equitable and ethical use.

Adapting the ordre public and morality exclusion of European patent law to accommodate emerging technologies

Nature Biotechnology
Volume 38 Issue 5, May 2020
https://www.nature.com/nbt/volumes/38/issues/5

 

Patents | 11 May 2020
Adapting the ordre public and morality exclusion of European patent law to accommodate emerging technologies
Patent law’s existing public policy exclusion should be reinterpreted and a new method introduced for assessing the moral and public policy implications of commercializing emerging technologies.

If the world fails to protect the economy, COVID-19 will damage health not just now but also in the future

Nature Medicine
Volume 26 Issue 5, May 2020
https://www.nature.com/nm/volumes/26/issues/5

 

Comment | 09 April 2020
If the world fails to protect the economy, COVID-19 will damage health not just now but also in the future
Previous crises have shown how an economic crash has dire consequences for public health. But in the COVID-19 pandemic, the world is entering uncharted territory. The world’s leaders must prepare to preserve health.
Martin McKee & David Stuckler

Policy opportunities to enhance sharing for pandemic research

Science
15 May 2020 Vol 368, Issue 6492
http://www.sciencemag.org/current.dtl

 

Policy Forum
Policy opportunities to enhance sharing for pandemic research
By Michelle Rourke, Mark Eccleston-Turner, Alexandra Phelan, Lawrence Gostin
Science15 May 2020 : 716-718 Full Access
COVID-19 reveals gaps in international law that can inhibit timely sharing of information, samples, and sequences

Effective containment explains subexponential growth in recent confirmed COVID-19 cases in China

Science
15 May 2020 Vol 368, Issue 6492
http://www.sciencemag.org/current.dtl

 

Research Articles
Effective containment explains subexponential growth in recent confirmed COVID-19 cases in China
By Benjamin F. Maier, Dirk Brockmann
Science15 May 2020 : 742-746 Open Access CCBY
Feedback between the epidemic process, the behavioral response to it, and nationwide containment policies can restrain COVID-19.

Childhood vaccinations and adult schooling attainment: Long-term evidence from India’s Universal Immunization Programme

Social Science & Medicine
Volume 250 April 2020
https://www.sciencedirect.com/journal/social-science-and-medicine/vol/250/suppl/C

 

Research article Open access
Childhood vaccinations and adult schooling attainment: Long-term evidence from India’s Universal Immunization Programme
Arindam Nandi, Santosh Kumar, Anita Shet, David E. Bloom, Ramanan Laxminarayan
Article 112885
Highlights
:: Vaccines could provide a broad range of health and non-health benefits.
:: We examined the link between childhood vaccination and adult schooling in India.
:: India’s UIP was associated with 0.2–0.3 additional schooling grades.

Ebola vaccine? Family first! Evidence from using a brief measure on Ebola vaccine demand in a national household survey during the outbreak in Sierra Leone

Vaccine
Volume 38, Issue 22 Pages 3811-3918 (8 May 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/22

 

Selected Content
Research article Abstract only
Ebola vaccine? Family first! Evidence from using a brief measure on Ebola vaccine demand in a national household survey during the outbreak in Sierra Leone
Mohamed F. Jalloh, Aaron S. Wallace, Rebecca E. Bunnell, Rosalind J. Carter, … Helena Nordenstedt
Pages 3854-3861

Confidence in the National Immunization Program among parents in Sweden 2016 – A cross-sectional survey

Vaccine
Volume 38, Issue 22 Pages 3811-3918 (8 May 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/22

 

Research article Open access
Confidence in the National Immunization Program among parents in Sweden 2016 – A cross-sectional survey
Emma Byström, Ann Lindstrand, Jakob Bergström, Kristian Riesbeck, Adam Roth
Pages 3909-3917

Are the Objectives Proposed by the WHO for Routine Measles Vaccination Coverage and Population Measles Immunity Sufficient to Achieve Measles Elimination from Europe?

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 16 May 2020)

 

Open Access Article
Are the Objectives Proposed by the WHO for Routine Measles Vaccination Coverage and Population Measles Immunity Sufficient to Achieve Measles Elimination from Europe?
by Pedro Plans-Rubió
Vaccines 2020, 8(2), 218; https://doi.org/10.3390/vaccines8020218 – 13 May 2020
Viewed by 139
Abstract
Background: The World Health Organization (WHO) proposed two-dose measles vaccination coverage of at least 95% of the population and percentages of measles immunity in the population of 85%−95% in order to achieve measles elimination in Europe. The objectives of this study were: (1) [