Milestones :: Perspectives :: Research

U.S. President: Statement on Withdrawal from WHO
May 29, 2020
[CNN report and video clip; no government transcript identified]

“…Because they have failed to make the requested and greatly needed reforms, we will be today terminating our relationship with the World Health Organization and redirecting those funds to other worldwide and deserving, urgent global public health needs…”

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EU: US announcement on breaking ties with the World Health Organisation: Statement by the President of the Commission Ursula von der Leyen and High Representative/Vice-President Josep Borrell
Brussels, 30/05/2020 – 13:46
As the world continues to fight the COVID-19 pandemic, the main task for everyone is to save lives and contain and mitigate this pandemic. The European Union continues to support the WHO in this regard and have already provided additional funding.

In an EU-led resolution adopted by consensus on 19 May at the World Health Assembly, all WHO Member States agreed to initiate, at the earliest appropriate moment, an impartial, independent and comprehensive evaluation to review lessons learnt from the international health response to the coronavirus, notably with the objective of strengthening future global health security preparedness.

Evaluating our global response is necessary as there are lessons to be learnt from this pandemic, its outbreak and response to it. The evaluation of our collective performance at international level is only a necessary process, aiming at strengthening health security.

Global cooperation and solidarity through multilateral efforts are the only effective and viable avenues to win this battle the world is facing. The WHO needs to continue being able to lead the international response to pandemics, current and future. For this, the participation and support of all is required and very much needed. In the face of this global threat, now is the time for enhanced cooperation and common solutions. Actions that weaken international results must be avoided. In this context, we urge the US to reconsider its announced decision.

Milestones :: Perspectives :: Research

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 30 May 2020)
Editorial
Pandemic preparedness and responses: WHO to turn to in a crisis?
The PLOS Medicine Editors
| published 29 May 2020 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1003167

In the thick of a global pandemic, it should be straightforward to appreciate the role and responsibilities of the World Health Organization (WHO). With a newly emerged coronavirus, SARS-CoV-2, exerting an appalling global toll in terms of lives lost, ill-health, and societal and economic disruption, the organization is a fulcrum on which all efforts to combat the COVID-19 outbreak and manage its consequences must be based. As of April 30, in excess of 3.2 million cases had been recorded, with more than 227,000 deaths attributed to the disease [¹]. WHO Director-General Tedros Adhanom Ghebreyesus, who has led the agency since 2017, has been prominent in the response to the coronavirus outbreak, not least in his authoritative public appearances. Yet the rapidity of the pandemic’s growth, and the diverse and apparently tentative responses in certain countries, have created concerns in some quarters about the agency’s capabilities to advise on and respond to disease outbreaks. Indeed, on April 14, a short suspension of US funding for WHO was announced, prompted by alleged suppression of information about the COVID-19 outbreak during its early stages in China [²]. Little is certain about the course and possible conclusion of the current outbreak, save that the actions and attributes of WHO, its structures, and its people will be scrutinized in the minutest possible detail.

WHO is tasked with forcefully representing international resolutions, creating confidence in its unparalleled technical capacity, and acting fairly and responsibly to promote health and wellbeing in all countries, as far as is possible. These countries vary enormously in population size and structure, wealth, political objectives and many other characteristics, of course. Consequently, the element of WHO’s 1946 Constitution that posits achievement of “the enjoyment of the highest attainable state of health … [by] every human being without distinction” may—perversely given its universal appeal—be subordinated to other, more short-term, factors [³]. It is easy to imagine situations in which attaching blame to an international body might be an attractive route to political or economic advantage. WHO’s revenue was about $2.9 billion in 2018 [⁴], made up of assessed and voluntary contributions, the latter category often linked to specific programmes or aims by donors. Large donors and countries are therefore likely to have, or be perceived to have, influence over its actions and announcements. WHO’s physical and human footprint is also criticized from time to time, and even ardent supporters would concede that, were the agency to be designed and launched today, its Swiss headquarters, along with 6 regional fiefdoms and 150 country offices, could well be reimagined in a much more streamlined fashion.

As we discussed in an Editorial in 2016 [⁵], WHO’s record in previous infectious disease outbreaks has not always met with unqualified approval. The agency’s response to the 2012–2014 Ebola outbreak in West Africa, under previous Director-General Margaret Chan, was seen to have been plagued by delay and dysfunction. In the subsequent reports that investigated WHO’s perceived failings, it was noted that the organization had, for example, previously cut a substantial proportion of its emergency response capability, and “lacked the governance needed to coordinate multiple stakeholders” in the response to a disease outbreak [⁶]. Essentially, there was a sense that the organization had been trying to do too many things with too few resources, and making questionable strategic decisions in the process.

The recent suspension of US funding for WHO has elicited criticism from many in the health arena, including PLOS [⁷]. Additional political manoeuvring has followed [⁸], and subsequently China has trumped the announcements by pledging an additional $30 million in funding, noting that WHO had been “actively fulfilling its duties and upholding an objective, scientific and impartial stance” on the disease outbreak [⁹]. These opportunistic political gambits could well continue in longer campaigns seeking to acquire plaudits for perceived (but at this stage perhaps ephemeral) successes in addressing the continuing outbreak, alongside creative attribution of responsibility for early, and possibly onging, errors and omissions in country-specific pandemic responses; wilful misinformation must also be considered as a factor.

We contacted a number of commentators for their views on the emerging debate around WHO’s role in the current outbreak, and Margaret Kruk, of the Harvard T.H. Chan School of Public Health, argues that “WHO plays an indispensable role in our shared health and it is one of the few institutions that is seen as credible in countries at a time that health and science are increasingly politicized. But it is hamstrung by insufficient, strings-tied funding and a governance structure that precludes its ability to speak uncomfortable truths for fear of offending member countries. The goal of reforms should be to build a technically stronger, better funded, and more independent WHO”. Although far too early to make definitive judgments about individual country or agency actions during the current pandemic, we can anticipate a frank debate about the capabilities and actions of WHO throughout this extraordinary time. Among thoughts that come to mind are, first, that political involvement with or by WHO is regrettable, with its parent organization, the United Nations, the forum for this purpose. Second, the experiences of the current pandemic need to be put to good use to prepare WHO and countries for future disease outbreaks—how do the agency’s capabilities and infrastructure, and indeed those of country public health bodies, need to be strengthened and adapted to this end? It may be that the function of WHO needs to be refocused on convening expertise and providing normative guidance for health goals, with a distinct entity, akin to UNAIDS, adopting responsibility for outbreak surveillance and responses. Finally, a global agency for health will remain essential, and all governments should seek to work with rather than counter to WHO as an essential partner in promoting the increasingly interconnected state of the world’s health.

References at title link above.

Milestones :: Perspectives :: Research

COVID-19 :: R&D Collaboration

International community rallies to support open research and science to fight COVID-19
29 May 2020 News release
Geneva
WHO and Costa Rica launch landmark COVID-19 Technology Access Pool
Thirty countries and multiple international partners and institutions have signed up to support the COVID-19 Technology Access Pool (C-TAP) an initiative aimed at making vaccines, tests, treatments and other health technologies to fight COVID-19 accessible to all.

The Pool was first proposed in March by President Carlos Alvarado of Costa Rica, who joined WHO Director-General Dr Tedros Adhanom Ghebreyesus today at the official launch of the initiative.

“The COVID-19 Technology Access Pool will ensure the latest and best science benefits all of humanity,” said President Alvarado of Costa Rica. “Vaccines, tests, diagnostics, treatments and other key tools in the coronavirus response must be made universally available as global public goods”. 

“Global solidarity and collaboration are essential to overcoming COVID-19,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Based on strong science and open collaboration, this information-sharing platform will help provide equitable access to life-saving technologies around the world.”

The COVID-19 (Technology) Access Pool will be voluntary and based on social solidarity. It will provide a one-stop shop for scientific knowledge, data and intellectual property to be shared equitably by the global community.

The aim is to accelerate the discovery of vaccines, medicines and other technologies through open-science research, and to fast-track product development by mobilizing additional manufacturing capacity. This will help ensure faster and more equitable access to existing and new COVID-19 health products.

There are five key elements to the initiative:
:: Public disclosure of gene sequences and data;
:: Transparency around the publication of all clinical trial results;
:: Governments and other funders are encouraged to include clauses in funding agreements with pharmaceutical companies and other innovators about equitable distribution, affordability and the publication of trial data;
:: Licensing any potential treatment, diagnostic, vaccine or other health technology to the Medicines Patent Pool – a United Nations-backed public health body that works to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries.
:: Promotion of open innovation models and technology transfer that increase local manufacturing and supply capacity, including through joining the Open Covid Pledge and the Technology Access Partnership (TAP).

With supportive countries across the globe, C-TAP will serve as a sister initiative to the Access to COVID-19 Tools (ACT) Accelerator and other initiatives to support efforts to fight COVID-19 worldwide.

WHO, Costa Rica and all the co-sponsor countries have also issued a “Solidarity Call to Action” asking relevant stakeholders to join and support the initiative, with recommended actions for key groups, such as governments, research and development funders, researchers, industry and civil society…

To date, the COVID-19 Technology Access Pool is now supported by the following countries: Argentina, Bangladesh, Barbados, Belgium, Belize, Bhutan, Brazil, Chile, Dominican Republic, Ecuador, Egypt, El Salvador, Honduras, Indonesia, Lebanon, Luxembourg, Malaysia, Maldives, Mexico, Mozambique, Norway, Oman, Pakistan, Palau, Panama, Peru, Portugal, Saint Vincent and Grenadines, South Africa, Sri Lanka,Sudan, The Netherlands, Timor-Leste, Uruguay, Zimbabwe,

Other international organizations, partners and experts have also expressed support to the initiative and others can join them using the website.

Milestones :: Perspectives :: Research

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
IGBA Statement // Solidarity Call to Action: To realize equitable global access to COVID-19 health technologies through sharing of knowledge, intellectual property and data
29 May 2020
“The International Generic and Biosimilar medicines Association (IGBA) invites generic and biosimilar medicines manufacturers to actively engage and commit to contributing to the global manufacturing capacity once an existing or newly-discovered therapeutic is proven to be effective against COVID-19.

“As stipulated by this unique and time-limited New Health Technology Pool, sharing of open relevant technologies, knowledge, intellectual property and data on a voluntary basis will facilitate their use in research and development and will mobilize and expand additional manufacturing capacity, since effective technology transfers and early access to key technologies would be permitted. This should be complimented by a clear policy action by WHO member states to plan for future need in full transparency and cooperation with the pharmaceutical industry, both rights holders and, where applicable, licensees.

“A framework will be provided, allowing generic and biosimilar medicines manufacturers to actively contribute to the global manufacturing capacity by utilizing their expertise and know-how to produce and distribute generic and biosimilar versions of patented medicines at global level.

“The licenses will also provide the freedom to develop new treatments, such as fixed-dose combinations and special formulations for children.

“Competition will help bring prices down and accelerate access to COVID-19 treatments and help to overcome this global pandemic.”

EMERGENCIES

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

:: WHO COVID-19 Webpage: https://www.who.int/emergencies/diseases/novel-coronavirus-2019
:: Daily WHO situation reports here: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports
:: WHO Coronavirus disease (COVID-2019) daily press briefings here: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/media-resources/press-briefings

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Emergencies

Ebola – DRC+
Public Health Emergency of International Concern (PHEIC)

Ebola Outbreak in DRC 94: 26 May 2020
[Excerpts]
Situation Update WHO Health Emergencies Programme Page 2
From 18 to 24 May 2020, no new confirmed cases of Ebola virus disease (EVD) have been reported in the Democratic Republic of the Congo. The definitive source of infection of the cluster reported in April 2020 remains unidentified. In the last seven days, two historic probable cases were validated, from people who had onset of symptoms in March 2019 and July 2019.…

Conclusion
Investigations into the origin of the last cluster of cases in Beni Health Zone are ongoing. The Ministry of Health began the 42-day countdown to the declaration of the end of the EVD outbreak on 14 May 2020. Given the long duration and large magnitude of the Ebola outbreak in North Kivu, South Kivu and Ituri Provinces, as well as the fact that the virus is present in animal reservoirs in the region, there is a risk of re-emergence of the virus in the period leading up to, and beyond, the declaration of the end of the outbreak. In the coming weeks it is crucial to maintain a strong and robust surveillance system in order to detect, isolate, test and treat new suspected cases as early as possible, to improve outcome of potential cases, and to break new chains of transmission. Continued coordination, communication among partners, authorities and affected communities along with EVD survivor advocacy remain essential in this outbreak response.

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

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 26 May 2020
Summary of new viruses this week (AFP cases and ES positives):
:: Afghanistan: three WPV1 positive environmental samples and five cVDPV2 positive environmental samples
:: Pakistan: two WPV1 cases and four WPV1 positive environmental samples
:: Niger: three cVDPV2 cases
:: Democratic Republic of the Congo (DR Congo): one cVDPV2 case
:: Ethiopia: four cVDPV2 cases
:: Ghana: three cVDPV2 cases
:: Togo: one cVDPV2 case
:: Côte d’Ivoire: four cVDPV2 positive environmental samples

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::::::

WHO Grade 3 Emergencies [to 30 May 2020]

Democratic Republic of the Congo
:: Ebola Outbreak in DRC 94: 26 May 2020
[See Ebola above for detail]

Somalia
:: WHO intensifies support to improve case management in Somalia as COVID-19 cases soar
20 May 2020

Yemen
:: Health care workers, a fragile health system and the looming spectre of COVID-19 in Yemen
27 May 2020

Nigeria – No new digest announcements identified
South Sudan – No new digest announcements identified
Syrian Arab Republic – No new digest announcements identified

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WHO Grade 2 Emergencies [to 30 May 2020]
Sudan
:: Training health workers to fight COVID-19 in Sudan 28 May 2020

Angola – No new digest announcements identified
Afghanistan – No new digest announcements identified
Burkina Faso [in French] – No new digest announcements identified
Burundi – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Ethiopia – No new digest announcements identified
Iran – No new digest announcements identified
Iraq – No new digest announcements identified
Libya – No new digest announcements identified
Malawi – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Myanmar – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

::::::

WHO Grade 1 Emergencies [to 30 May 2020]

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

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::::::

UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: Humanitarian Update Syrian Arab Republic – Issue 11 | 30 May 2020
:: Recent Developments in Northwest Syria – Flash Update – As of 29 May 2020

Yemen – No new digest announcements identified

::::::

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
CYCLONE IDAI and Kenneth
:: 29 May 2020 Ethiopia: Floods impact thousands of people

:: EBOLA OUTBREAK IN THE DRC – No new digest announcements identified

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WHO & Regional Offices [to 30 May 2020]
29 May 2020 News release
Stop tobacco industry exploitation of children and young people

29 May 2020 News release
International community rallies to support open research and science to fight COVID-19

27 May 2020 News release
Countries failing to stop harmful marketing of breast-milk substitutes, warn WHO and UNICEF

27 May 2020 News release
WHO Foundation Established to Support Critical Global Health Needs
The World Health Organization (WHO) welcomes the creation of the WHO Foundation, an independent grant-making entity, that will support the Organization’s efforts to address the most pressing global health challenges.
Headquartered in Geneva, the Foundation will support global public health needs by providing funds to WHO and trusted implementing partners to deliver on the Organization’s “triple billion” goals. Featured in WHO’s five-year strategic plan, these goals aim to: protect 1 billion people from health emergencies; extend universal health coverage to 1 billion people; and assure healthy lives and wellbeing to 1 billion people by 2023.
The Foundation, which is legally separate from WHO, will facilitate contributions from the general public, individual major donors and corporate partners to WHO and trusted partners to deliver on high-impact programmes. Its goal is to help broaden WHO’s donor base and work towards more sustainable and predictable funding.  The WHO Foundation will simplify the processing of philanthropic contributions in support of WHO and make such contributions possible on all aspects of health and WHO’s mission.
“An important part of WHO’s future success is broadening its donor base and increasing both the quantity and quality of funds at its disposal,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “The creation of the WHO Foundation, as part of WHO’s transformation, is an important step towards this goal, and towards achieving our mission to promote health, keep the world safe and serve the vulnerable.”…

27 May 2020 News release
The World Health Organization, UN Foundation and Illumination partner on health messages

::::::

Weekly Epidemiological Record, 29 May 2020, vol. 95, 22 (pp. 241–256)
Meeting of the Strategic Advisory Group of Experts on Immunization, 31 March–1 April 2020: conclusions and recommendations

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Africa COVID-19 cases top 100 000 22 May 2020
The COVID-19 pandemic today reached a milestone in Africa, with more than 100 000 confirmed cases. The virus has now spread to every country in the continent since the first case was confirmed in the region 14 weeks ago.
:: WHO showcases leading African innovations in COVID-19 response 21 May 2020
A community of African innovators is stepping up support to the continent’s fight against COVID-19 pandemic, collaborating with the World Health Organization (WHO) to develop solutions to help contain the spread of the virus.

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

WHO South-East Asia Region SEARO
:: India elected chair of WHO’s Executive Board 22 May 2020

WHO European Region EURO
:: Embracing cultural diversity unlocks key resources for more inclusive health systems 20-05-2020
:: WHO report on health behaviours of 11–15-year-olds in Europe reveals more adolescents are reporting mental health concerns 19-05-2020
:: HealthBuddy: a new chatbot to engage with communities in Europe and central Asia on COVID-19 18-05-2020

WHO Eastern Mediterranean Region EMRO
:: Statement by WHO’s Regional Director for the Eastern Mediterranean Dr Ahmed Al-Mandhari on regional solidarity during the COVID-19 pandemic
20 May 2020 – The current COVID-19 pandemic has shown us all the severe and unimaginable impact that a public health threat can have on individuals, communities and nations. We have often said that infectious diseases respect no borders, and that an outbreak in one country can threaten the health security of the Region and beyond. Today, we are witnessing…

WHO Western Pacific Region
No new digest content identified.

CDC/ACIP [to 30 May 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases
United States Coronavirus (COVID-19) Death Toll Surpasses 100,000
Thursday, May 28, 2020

MMWR News Synopsis Friday, May 29, 2020
Evaluation of a Program To Improve Linkage to and Retention in Care Among Refugees with Hepatitis B Virus Infection — Three U.S. Cities, 2006–2018

Universal and Serial Laboratory Testing for SARS-CoV-2 at a Long-Term-Care Skilled-Nursing Facility for Veterans — Los Angeles, California, 2020 (Early release May 22, 2020)

Africa CDC [to 30 May 2020]
http://www.africacdc.org/
News
Press Releases
African Union Commission announces Africa CDC Kofi Annan Global Health Leadership Programme
25 May 2020

Press Releases
Africa CDC deploys 28 frontline responders to Burkina Faso, Cameroon, Mali and Niger using African Union strategic lift capability
25 May 2020

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 30: Daily briefing on novel coronavirus cases in China
On May 29, 31 provincial-level regions on the Chinese mainland as well as the Xinjiang Production and Construction Corps reported 4 new cases of confirmed infections, 1 new case of suspected infections and no deaths.

Research well underway into COVID-19 vaccines and drugs, premier says
2020-05-29
China and many other countries are investing into the research and development of vaccines, effective drugs and testing agents, which, when available, should become public goods, Premier Li Keqiang said on May 28, adding China is ready to share those products.
All countries are working on preventing and controlling the spread of this new contagion and are gaining experience along the way, Li said at a video news conference, adding vaccines, effective drugs and testing agents are powerful weapons humanity can use to overcome the virus.
China, like many other countries, believes there should be efforts to research the origin of the novel coronavirus, as such efforts will help containing the COVID-19 pandemic and protect the lives and health of the people around the world, he added…

Announcements
 
 
Paul G. Allen Frontiers Group    [to 30 May 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.
 
 
BARDA   [to 30 May 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
No new digest content identified.
 
 
BMGF – Gates Foundation  [to 30 May 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute    [to 30 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 30 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.
05.28.2020
CARB-X funds Microbion to develop inhaled drug to treat cystic fibrosis-related lung infections
CARB-X is awarding Microbion Corporation of Bozeman, MT, USA, up to $6.1 million plus up to $5.4 million more if certain project milestones are met, to develop its anti-infective drug pravibismane for the treatment of cystic fibrosis (CF)-related pulmonary infections.
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 30 May 2020]
http://cepi.net/
Latest News
Novavax COVID-19 vaccine candidate begins clinical trials
The Novavax vaccine candidate is the fourth CEPI-funded COVID-19 vaccine to enter the clinic.
Blog
26 May 2020
 
 
Clinton Health Access Initiative, Inc. (CHAI)  [to 30 May 2020]
https://clintonhealthaccess.org/
News & Press Releases
No new digest content identified.
 
 
EDCTP    [to 30 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
25 May 2020
EDCTP-co-funded visceral leishmaniasis treatment trial completes recruitment
 
 
Emory Vaccine Center    [to 30 May 2020]
http://www.vaccines.emory.edu/
[Undated]
No new digest content identified.
 
 
European Medicines Agency  [to 30 May 2020]
http://www.ema.europa.eu/ema/
News & Press Releases ·
Press release: COVID-19: reminder of the risks of chloroquine and hydroxychloroquine
Last updated: 29/05/2020
Press release: New vaccine for prevention of Ebola virus disease recommended for approval in the European Union
CHMP, Last updated: 29/05/2020
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
CHMP, Last updated: 29/05/2020
Press release: Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3
Last updated: 28/05/2020
 
 
European Vaccine Initiative  [to 30 May 2020]
http://www.euvaccine.eu/news-events
Latest News
No new digest content identified.
 
 
FDA [to 30 May 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
May 29, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020
May 29, 2020 – Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection
May 28, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020
May 27, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 27, 2020
May 27, 2020 – Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection
May 26, 2020 – FDA Approves Only Drug in U.S. to Treat Severe Malaria
Today, the U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients. Treatment of severe malaria with intravenous (IV) artesunate should always be followed by a complete treatment course of an appropriate     oral antimalarial regimen.
Prior to this approval, IV artesunate was only available to patients through the FDA’s Expanded Access program, which allowed the U.S. Centers for Disease Control and Prevention (CDC) to provide IV artesunate to U.S. patients with severe malaria and to patients with uncomplicated malaria who are unable to take oral medications under an investigational new drug (IND) protocol. There has been no FDA-approved drug for treatment of severe malaria in the United States since the marketing of quinine was discontinued by the manufacturer in March 2019…
May 26, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 26, 2020
 
 
Fondation Merieux  [to 30 May 2020]
http://www.fondation-merieux.org/
News, Events
Appui aux laboratoires RESAOLAB
COVID-19: RESAOLAB mobilized and reinforced to contend with the epidemic in West Africa
May 27, 2020 – West Africa
The West African Network of Biomedical Analysis Laboratories (RESAOLAB), of which the third phase was launched end 2019, has set up a special Covid-19 unit to reinforce the diagnostic capacities of its member countries and to prevent the spread of the virus, with the support of the Agence française de développement (AFD) and the Mérieux Foundation.
 
 
Gavi [to 30 May 2020]
https://www.gavi.org/
News releases
Virtual Conference
4 June 2020
The UK government will host Gavi’s third donor pledging conference to mobilise at least US$ 7.4 billion in additional resources to protect the next generation with vaccines, reduce disease inequality and create a healthier, safer and more prosperous world.
26 May 2020
New Zealand announces NZ$ 7 million pledge to Vaccine Alliance
 
 
GHIT Fund   [to 30 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 30 May 2020]
https://www.theglobalfund.org/en/news/
Sourcing & Management of Health Products
Updates
Strategy Development Open Consultation
29 May 2020
The Global Fund has launched an open consultation to develop the next Global Fund Strategy.
We strongly encourage all stakeholders to contribute to this consultation by identifying the most pressing challenges and opportunities in the fight against the three diseases; building resilient and sustainable systems for health; promoting and protecting human rights and gender equality; and mobilizing resources. We also want your views as to how these priorities are affected by the COVID-19 pandemic and broader changes in the health and development landscape. We have prepared a series of framing questions to answer.

See how to contribute and read background information on our new Strategy Development page.
Voices
On the Front Lines: Responding to COVID-19
28 May 2020
Sourcing & Management of Health Products
COVID-19 Response: Diagnostics Procurement
27 May 2020
Voices
COVID-19 Threatens to Derail Fight Against HIV, TB and Malaria
27 May 2020
Updates
Search for Independent Members of the Inspector General Nomination Committee
25 May 2020
 
 
Hilleman Laboratories   [to 30 May 2020]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 30 May 2020]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
 
 
IAVI  [to 30 May 2020]
https://www.iavi.org/newsroom
Press Releases
May 26, 2020
IAVI and Merck Collaborate to Develop Vaccine Against SARS-CoV-2

KENILWORTH, N.J., and NEW YORK, N.Y., MAY 26, 2020 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, and IAVI, a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, today announced a new collaboration to develop an investigational vaccine against SARS-CoV-2 to be used for the prevention of COVID-19. This vaccine candidate will use the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s Ebola Zaire virus vaccine, ERVEBO® (Ebola Zaire Vaccine, Live), which was the first rVSV vaccine approved for use in humans. Merck has also signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within an agency of the United States Department of Health and Human Services, to provide initial funding support for this effort.
Under the agreement IAVI and Merck will work together to advance the development and global clinical evaluation of a SARS-CoV-2 vaccine candidate designed and engineered by IAVI scientists. The vaccine candidate is in preclinical development, and clinical studies are planned to start later in 2020. Merck will lead regulatory filings globally. Both organizations will work together to develop the vaccine and make it accessible and affordable globally, if approved…
 
 
International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
ICMRA meeting on international alignment during COVID-19 pandemic #4 (27 May 2020)
… Participants of the high-level meeting exchanged information about the growing number of medicines that are in development or in clinical trials to assess their safety and efficacy for the treatment or prevention of COVID-19…
 
 
International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
IGBA Statement // Solidarity Call to Action: To realize equitable global access to COVID-19 health technologies through sharing of knowledge, intellectual property and data (29 May 2020)
[See Milestones above for detail]
 
 
IFFIm
http://www.iffim.org/
Press Releases
No new digest content identified.
 
 
IFRC   [to 30 May 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
International Red Cross and Red Crescent Movement appeals for 3.1 billion Swiss francs (3.19 billion US dollars) to curb COVID-19’s spread and assist world’s most vulnerable amid the pandemic
Geneva, 28 May 2020 –-The International Red Cross and Red Crescent Movement is appealing for 3.1 billion Swiss francs (3.19 billion US dollars) to urgently scale up its global response to curb COVID-19’s rapid spread and assist the world’s most vulnerable people amid the pandemic.
28 May 2020
 
 
IVAC  [to 30 May 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
No new digest content identified.
 
 
IVI   [to 30 May 2020]
http://www.ivi.int/
Selected IVI News & Announcements
No new digest content identified.
 
 
JEE Alliance  [to 30 May 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 30 May 2020]
http://www.msf.org/
Latest [Selected Announcements]
Coronavirus COVID-19 pandemic
MSF opens COVID-19 centre in Venezuela
Project Update 29 May 2020
Coronavirus COVID-19 pandemic
Continuing essential medical services during COVID-19
Project Update 28 May 2020
Coronavirus COVID-19 pandemic
Unregulated market for personal protective equipment puts lives at r…
Press Release 28 May 2020
Brazil
MSF responds to the COVID-19 pandemic in Amazonas
Press Release 27 May 2020
Coronavirus COVID-19 pandemic
Offering extra protection against COVID-19 to Lebanon’s most vulnera…
Project Update 26 May 2020
 
 
Coronavirus COVID-19 pandemic
MSF concludes COVID-19 response in Spain
Press Release 25 May 2020
 
 
National Vaccine Program Office – U.S. HHS  [to 30 May 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC 2020 Meetings
June 9-10, 2020 NVAC Meeting (Virtual)
September 23-24, 2020 Meeting (Virtual)
 
 
NIH  [to 30 May 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH releases strategic plan to accelerate nutrition research over next 10 years
May 27, 2020 — With a focus on precision nutrition, the plan reflects the wide range of nutrition research supported across the agency.
 
 
PATH  [to 30 May 2020]
https://www.path.org/media-center/
Selected Announcements
No new digest content identified.
 
 
Sabin Vaccine Institute  [to 30 May 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.
 
 
UNAIDS [to 30 May 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
29 May 2020
Caribbean community organizations call for decisive action to end homophobic abuse and cyberbullying
28 May 2020
“My biggest concern is to get my antiretroviral medicines”: HIV and COVID-19 in Latin America
27 May 2020
Pia Wurtzbach on how she is helping the response to COVID-19
26 May 2020
“When people are asked to isolate themselves, we also need to make sure that they have food and medicine”
25 May 2020
“We are in this together”: Uganda Young Positives respond to COVID-19
25 May 2020
Modelling the extreme—COVID-19 and AIDS-related deaths
 
 
UNICEF  [to 30 May 2020]
https://www.unicef.org/media/press-releases
Selected Press releases/Announcements
Press release
COVID-19: Number of children living in household poverty to soar by up to 86 million by end of year
New analysis from Save the Children and UNICEF reveals that without urgent action, the number of children living in poor households across low- and middle-income countries could increase by 15 per cent, to reach 672 million
27/05/2020
Press release
Countries failing to stop harmful marketing of breast-milk substitutes, warn WHO and UNICEF
Agencies encourage women to continue to breastfeed during the COVID-19 pandemic
27/05/2020
 
 
Unitaid  [to 30 May 2020]
https://unitaid.org/
Featured News
29 May 2020
Unitaid backs WHO and Costa Rica call to action on pooling of knowledge and rights for COVID-19 global public goods

Geneva — Unitaid welcomes the call by WHO and the President of Costa Rica for the voluntary pooling of knowledge, intellectual property and data for COVID-19 health technologies to help ensure equitable access to global public goods.

WHO Director-General Dr Tedros Adhanom Ghebreyesus and President Carlos Alvarado Quesada of Costa Rica launched the initiative at a digital event on Friday 29 May, together with the support of a large number of Member States and international organisation. The ‘Solidarity Call to Action’ targets governments, public and private sector funders of research, pharmaceutical industry, as well as researchers themselves.

Marisol Touraine, Chair of the Unitaid Executive Board and former French health minister said, “Equitable access to better medicines, tests and preventive methods is at the heart of Unitaid’s work – not just for COVID-19 but for HIV, tuberculosis, malaria and other diseases.” She continues, “We very much support the call for non-exclusive and global voluntary licensing through the Unitaid-established and supported Medicines Patent Pool, as well as through other mechanisms such as the UN Technology Bank-WHO TechAccess Partnership.”

Speaking at the launch, Dr Philippe Duneton, Unitaid Executive Director a.i., said. “Voluntary pooling is an important step in towards equitable access to COVID-19 medicines and tests. Intellection property rights are not the problem here, it is the way in which they are used. We expect the pharmaceutical industry to turn IP rights into solutions. Unitaid has created and supported MPP, and it has shown the way for the HIV response; this model is also key for the COVID-19 response”. He continues, “Global threats need global solutions. Equitable access to vaccines, diagnostics and therapeutics is  key to ending this pandemic, and what’s more they also need to be affordable.”…
25 May 2020

Unitaid greets new Korean-led initiative to improve the global response to infectious diseases

Geneva –  Unitaid welcomes the launch of the Support Group for Global Infectious Disease Response (G4IDR), an initiative led by the Republic of Korea that seeks to capitalize on lessons learned from the COVID-19 pandemic. The Geneva-based group convenes several countries and will collaborate with the World Health Organization (WHO) and global health organizations including Unitaid.
Is it part of the wider ‘Group of Friends of Solidarity for Global Health Security’ launched on 12 May 2020 at the UN Headquarters in New York, USA.

The Geneva G4IDR initiative was launched by H.E. Mrs Kang Kyung-wha, Minister of Foreign Affairs of the Republic of Korea. Mrs Kang emphasised the role of global institutions in tackling global challenges and said that she hoped the G4IDR Support Group, “will play an important role in facilitating and coordinating cooperation between countries and health organizations, eventually strengthening the global response not only to COVID-19 but to future global health crises that can strike next.”…
 
 
Vaccination Acceptance Research Network (VARN)  [to 30 May 2020]
https://vaccineacceptance.org/news.html#header1-2r
Annoucements
No new digest content identified.
 
 
Vaccine Confidence Project  [to 30 May 2020]
http://www.vaccineconfidence.org/
Latest News & Archive
Feature
First measles, now COVID-19 – are outbreaks finally moving the dial on vaccine hesitancy?
May 2020
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 30 May 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
 
 
Wellcome Trust  [to 30 May 2020]
https://wellcome.ac.uk/news
Explainer | 29 May 2020
How can we get effective treatments for COVID-19?
From repurposed drugs to new therapies – researchers are working at incredible speed to find the best ways to treat COVID-19 patients.
 
 
The Wistar Institute   [to 30 May 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.
 
 
WFPHA: World Federation of Public Health Associations  [to 30 May 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.
 
 
World Organisation for Animal Health (OIE)   [to 30 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 30 May 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.
 
 
BIO    [to 30 May 2020]
https://www.bio.org/press-releases
Press Releases
Dr. Anthony Fauci, Dr.Moncef Slaoui and Top COVID-19 Thought Leaders Take Stage During BIO Digital Week
May 28, 2020
Anthony Fauci, M.D., National Institute of Allergy and Infectious Diseases Director and Moncef Slaoui, Ph.D., U.S. Operation Warp Speed Chief Advisor will speak on a special plenary session on Tuesday, June 9 during BIO Digital, a virtual conference…
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 30 May 2020]
http://www.dcvmn.org/
No new digest content identified.
 
 
IFPMA   [to 30 May 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Pharma partners in efforts to give coronavirus vaccine for everyone
28 May 2020
Geneva, 28 May 2020. IFPMA has today updated the world’s media on the biopharmaceutical industry’s unprecedented efforts, many of them in collaboration with others, to speed up research and development for a new COVID-19 vaccine. The body representing the global biopharmaceutical industry also highlighted at the briefing that plans are underway to scale up manufacturing at risk even though it is not sure yet which, if any, vaccines in development will be found to be safe and effective. Such investments decisions are unprecedented and demonstrate companies are not taking a “business as usual” approach in their response to the global pandemic.
The industry reaffirmed its acute awareness of the enormous responsibility it has to patients and society to bring its knowledge and expertise to bear, in collaboration and in partnership with others, in finding a coronavirus vaccine and thereby live up to the commitment it is giving to deliver safe, quality, effective, and affordable COVID-19 vaccines to all.
A new vaccine to protect people from COVID-19 holds the greatest promise of ending the pandemic, but there are no guarantees that one will be found. The biopharmaceutical industry is working at unparalleled speed and sparing no resources to develop safe and effective COVID-19 vaccines in record time. As of 27 May 2020, the WHO reports there are currently 10 candidate vaccines in clinical evaluation and 115 candidate vaccines in pre-clinical evaluation. Several biopharmaceutical companies are researching vaccine candidates and are collaborating in the sharing of existing technologies that can be leveraged to allow a rapid upscale of production once a vaccine candidate is identified. Companies are also sharing technologies that act as an adjuvant which can boost the effectiveness of a potential vaccine. [Overview of industry activities].

Thomas Cueni, IFPMA Director General, is acutely aware of the challenges: “Not only does the science have to be on our side if we are to quickly find a coronavirus vaccine, but we also have to find ways of being able to produce hundreds of millions, possible billions of doses of the new vaccine. Then people need to be vaccinated in sufficient numbers to protect whole communities. And, all the while, we should continue to produce existing vaccines”.

He admits the task in hand is larger than any attempted before and beyond the power of any single entity. Cueni explains: “The only way to deliver on our promise of safe, equitable, affordable coronavirus vaccines is for science and collaboration on a global scale to prevail. Be in no doubt, our member companies are fully engaged in the race to find a vaccine. We are fully committed to playing our full role within existing partnerships, such as ACT Accelerator and Gavi, on the basis that we wholeheartedly embrace the goal of providing new coronavirus vaccines for all”.

Looking to the upcoming Global Vaccine Summit on 4 June, and Gavi, the Vaccine Alliance replenishment, Cueni declared: “While we should give our undevoted attention to ending the COVID-19 pandemic, we must not fall into the trap of forgetting the need for ongoing immunization efforts to continue as well as being very vigilant in tracking any future virus”. He confirms that the biopharmaceutical industry will continue its 20-year history of working in partnership with Gavi, founded in 2000, that has led to nearly half the world’s children being protected against deadly and debilitating infectious diseases”.
Pharma industry updates advice on engaging with healthcare professionals as countries emerge from COVID-19 lockdown
28 May 2020
Geneva, 28 May 2020: As countries lift lockdown restrictions, the international pharma industry body, IFPMA, provides its members with ethical considerations on when and how to resume in-person meetings with healthcare practitioners and other stakeholders within the healthcare system.

During the COVID-19 pandemic, biopharmaceutical companies proactively interrupted face-to-face interactions between their representatives and physicians, in order to protect patients, healthcare professionals, and their own employees, and have replaced in-office visits and face-to-face congresses with online platforms, virtual meetings, webinars, etc.
Maintaining dialogue and scientific exchange with the medical community is critical to inform physicians about new possible treatments, alternative treatment protocols, product supply or safety/efficacy data. This meaningful engagement is even more critical during the COVID-19 pandemic, as physicians contend with the many medical questions of how the virus could affect their patients’ existing treatments and at the same time need to remain informed about general scientific information and treatment options. “During the lockdown, employees have stepped away from healthcare sites to limit the spread of the virus and protect patients, while maintaining remote interactions to continue to share scientific knowledge” explains Rady Johnson, Chair of the IFPMA Ethics and Business Integrity Committee, and Chief Compliance, Quality and Risk Officer at Pfizer. Looking to the future, he adds: “Maintaining productive dialogue and scientific exchange with the medical community is central to ensuring that all patients, COVID and non-COVID, receive the treatments needed to support their overall health and well-being. But even as doors open up, we want to preserve that dialogue and partnership without risk to the safety of patients, customers, our employees and communities. We remain committed to appropriately engaging healthcare professionals in-person when it is safe to do so, alongside our continued use of remote interaction channels”.
In these unprecedented times and the high level of unpredictability, the biopharmaceutical industry has found that its recently launched Ethos[1] has been indispensable in helping provide the necessary framework to anchor ethical decision-making, where no specific rules could have previously been anticipated. This principles-driven approach will continue to guide IFPMA members’ conduct as they adapt to the evolving COVID-19 operating environment…
 
 
ICBA – International Council of Biotechnology Associations   [to 30 May 2020]
https://internationalbiotech.org/
News
No new digest content identified.
 
 
PhRMA    [to 30 May 2020]
http://www.phrma.org/
Selected Press Releases, Statements
No new digest content identified.
 
 
Industry Watch   [to 30 May 2020]
:: Moderna Announces First Participants in Each Age Cohort Dosed in Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
May 29, 2020
:: Johnson & Johnson Receives Positive CHMP Opinion for Janssen’s Investigational Preventive Ebola Vaccine Regimen
May 29, 2020
 
Announcements
 
 
Paul G. Allen Frontiers Group    [to 30 May 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.
 
 
BARDA   [to 30 May 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
No new digest content identified.
 
 
BMGF – Gates Foundation  [to 30 May 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute    [to 30 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 30 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.
05.28.2020
CARB-X funds Microbion to develop inhaled drug to treat cystic fibrosis-related lung infections
CARB-X is awarding Microbion Corporation of Bozeman, MT, USA, up to $6.1 million plus up to $5.4 million more if certain project milestones are met, to develop its anti-infective drug pravibismane for the treatment of cystic fibrosis (CF)-related pulmonary infections.
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 30 May 2020]
http://cepi.net/
Latest News
Novavax COVID-19 vaccine candidate begins clinical trials
The Novavax vaccine candidate is the fourth CEPI-funded COVID-19 vaccine to enter the clinic.
Blog
26 May 2020
 
 
Clinton Health Access Initiative, Inc. (CHAI)  [to 30 May 2020]
https://clintonhealthaccess.org/
News & Press Releases
No new digest content identified.
 
 
EDCTP    [to 30 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
25 May 2020
EDCTP-co-funded visceral leishmaniasis treatment trial completes recruitment
 
 
Emory Vaccine Center    [to 30 May 2020]
http://www.vaccines.emory.edu/
[Undated]
No new digest content identified.
 
 European Medicines Agency  [to 30 May 2020]
http://www.ema.europa.eu/ema/
News & Press Releases ·
Press release: COVID-19: reminder of the risks of chloroquine and hydroxychloroquine
Last updated: 29/05/2020
Press release: New vaccine for prevention of Ebola virus disease recommended for approval in the European Union
CHMP, Last updated: 29/05/2020
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
CHMP, Last updated: 29/05/2020
Press release: Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3
Last updated: 28/05/2020
 
 
European Vaccine Initiative  [to 30 May 2020]
http://www.euvaccine.eu/news-events
Latest News
No new digest content identified.
 
 
FDA [to 30 May 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
May 29, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020
May 29, 2020 – Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection

May 28, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020
May 27, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 27, 2020
May 27, 2020 – Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection
May 26, 2020 – FDA Approves Only Drug in U.S. to Treat Severe Malaria
Today, the U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients. Treatment of severe malaria with intravenous (IV) artesunate should always be followed by a complete treatment course of an appropriate     oral antimalarial regimen.
Prior to this approval, IV artesunate was only available to patients through the FDA’s Expanded Access program, which allowed the U.S. Centers for Disease Control and Prevention (CDC) to provide IV artesunate to U.S. patients with severe malaria and to patients with uncomplicated malaria who are unable to take oral medications under an investigational new drug (IND) protocol. There has been no FDA-approved drug for treatment of severe malaria in the United States since the marketing of quinine was discontinued by the manufacturer in March 2019…
May 26, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 26, 2020
 
 
Fondation Merieux  [to 30 May 2020]
http://www.fondation-merieux.org/
News, Events
Appui aux laboratoires RESAOLAB
COVID-19: RESAOLAB mobilized and reinforced to contend with the epidemic in West Africa
May 27, 2020 – West Africa
The West African Network of Biomedical Analysis Laboratories (RESAOLAB), of which the third phase was launched end 2019, has set up a special Covid-19 unit to reinforce the diagnostic capacities of its member countries and to prevent the spread of the virus, with the support of the Agence française de développement (AFD) and the Mérieux Foundation.
 
 
Gavi [to 30 May 2020]
https://www.gavi.org/
News releases
Virtual Conference
4 June 2020
The UK government will host Gavi’s third donor pledging conference to mobilise at least US$ 7.4 billion in additional resources to protect the next generation with vaccines, reduce disease inequality and create a healthier, safer and more prosperous world.
26 May 2020
New Zealand announces NZ$ 7 million pledge to Vaccine Alliance
 
 
GHIT Fund   [to 30 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 30 May 2020]
https://www.theglobalfund.org/en/news/
Sourcing & Management of Health Products
Updates
Strategy Development Open Consultation
29 May 2020
The Global Fund has launched an open consultation to develop the next Global Fund Strategy.
We strongly encourage all stakeholders to contribute to this consultation by identifying the most pressing challenges and opportunities in the fight against the three diseases; building resilient and sustainable systems for health; promoting and protecting human rights and gender equality; and mobilizing resources. We also want your views as to how these priorities are affected by the COVID-19 pandemic and broader changes in the health and development landscape. We have prepared a series of framing questions to answer.
See how to contribute and read background information on our new Strategy Development page.
Voices
On the Front Lines: Responding to COVID-19
28 May 2020
Sourcing & Management of Health Products
COVID-19 Response: Diagnostics Procurement
27 May 2020
Voices
COVID-19 Threatens to Derail Fight Against HIV, TB and Malaria
27 May 2020
 
 
Search for Independent Members of the Inspector General Nomination Committee
25 May 2020
 
 
Hilleman Laboratories   [to 30 May 2020]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 30 May 2020]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
 
 
IAVI  [to 30 May 2020]
https://www.iavi.org/newsroom
Press Releases
May 26, 2020
IAVI and Merck Collaborate to Develop Vaccine Against SARS-CoV-2
KENILWORTH, N.J., and NEW YORK, N.Y., MAY 26, 2020 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, and IAVI, a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, today announced a new collaboration to develop an investigational vaccine against SARS-CoV-2 to be used for the prevention of COVID-19. This vaccine candidate will use the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s Ebola Zaire virus vaccine, ERVEBO® (Ebola Zaire Vaccine, Live), which was the first rVSV vaccine approved for use in humans. Merck has also signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within an agency of the United States Department of Health and Human Services, to provide initial funding support for this effort.
Under the agreement IAVI and Merck will work together to advance the development and global clinical evaluation of a SARS-CoV-2 vaccine candidate designed and engineered by IAVI scientists. The vaccine candidate is in preclinical development, and clinical studies are planned to start later in 2020. Merck will lead regulatory filings globally. Both organizations will work together to develop the vaccine and make it accessible and affordable globally, if approved…
 
 
International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
ICMRA meeting on international alignment during COVID-19 pandemic #4 (27 May 2020)
… Participants of the high-level meeting exchanged information about the growing number of medicines that are in development or in clinical trials to assess their safety and efficacy for the treatment or prevention of COVID-19…
 
 
International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
IGBA Statement // Solidarity Call to Action: To realize equitable global access to COVID-19 health technologies through sharing of knowledge, intellectual property and data (29 May 2020)
[See Milestones above for detail]
 
 
IFFIm
http://www.iffim.org/
Press Releases
No new digest content identified.
 
 
IFRC   [to 30 May 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
International Red Cross and Red Crescent Movement appeals for 3.1 billion Swiss francs (3.19 billion US dollars) to curb COVID-19’s spread and assist world’s most vulnerable amid the pandemic
Geneva, 28 May 2020 –-The International Red Cross and Red Crescent Movement is appealing for 3.1 billion Swiss francs (3.19 billion US dollars) to urgently scale up its global response to curb COVID-19’s rapid spread and assist the world’s most vulnerable people amid the pandemic.
28 May 2020
 
 
IVAC  [to 30 May 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
No new digest content identified.
 
 
IVI   [to 30 May 2020]
http://www.ivi.int/
Selected IVI News & Announcements
No new digest content identified.
 
 
JEE Alliance  [to 30 May 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 30 May 2020]
http://www.msf.org/
Latest [Selected Announcements]
Coronavirus COVID-19 pandemic
MSF opens COVID-19 centre in Venezuela
Project Update 29 May 2020
Coronavirus COVID-19 pandemic
Continuing essential medical services during COVID-19
Project Update 28 May 2020
Coronavirus COVID-19 pandemic
Unregulated market for personal protective equipment puts lives at r…
Press Release 28 May 2020
Brazil
MSF responds to the COVID-19 pandemic in Amazonas
Press Release 27 May 2020
Coronavirus COVID-19 pandemic
Offering extra protection against COVID-19 to Lebanon’s most vulnera…
Project Update 26 May 2020
 
 
Coronavirus COVID-19 pandemic
MSF concludes COVID-19 response in Spain
Press Release 25 May 2020
 
 
National Vaccine Program Office – U.S. HHS  [to 30 May 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC 2020 Meetings
June 9-10, 2020 NVAC Meeting (Virtual)
September 23-24, 2020 Meeting (Virtual)
 
 
NIH  [to 30 May 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH releases strategic plan to accelerate nutrition research over next 10 years
May 27, 2020 — With a focus on precision nutrition, the plan reflects the wide range of nutrition research supported across the agency.
 
 
PATH  [to 30 May 2020]
https://www.path.org/media-center/
Selected Announcements
No new digest content identified.
 
 
Sabin Vaccine Institute  [to 30 May 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.
 
 
UNAIDS [to 30 May 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
29 May 2020
Caribbean community organizations call for decisive action to end homophobic abuse and cyberbullying
28 May 2020
“My biggest concern is to get my antiretroviral medicines”: HIV and COVID-19 in Latin America
27 May 2020
Pia Wurtzbach on how she is helping the response to COVID-19
26 May 2020
“When people are asked to isolate themselves, we also need to make sure that they have food and medicine”
25 May 2020
“We are in this together”: Uganda Young Positives respond to COVID-19
25 May 2020
Modelling the extreme—COVID-19 and AIDS-related deaths
 
 
UNICEF  [to 30 May 2020]
https://www.unicef.org/media/press-releases
Selected Press releases/Announcements
Press release
COVID-19: Number of children living in household poverty to soar by up to 86 million by end of year
New analysis from Save the Children and UNICEF reveals that without urgent action, the number of children living in poor households across low- and middle-income countries could increase by 15 per cent, to reach 672 million
27/05/2020
Press release
Countries failing to stop harmful marketing of breast-milk substitutes, warn WHO and UNICEF
Agencies encourage women to continue to breastfeed during the COVID-19 pandemic
27/05/2020
 
 
Unitaid  [to 30 May 2020]
https://unitaid.org/
Featured News
29 May 2020
Unitaid backs WHO and Costa Rica call to action on pooling of knowledge and rights for COVID-19 global public goods
Geneva — Unitaid welcomes the call by WHO and the President of Costa Rica for the voluntary pooling of knowledge, intellectual property and data for COVID-19 health technologies to help ensure equitable access to global public goods.
WHO Director-General Dr Tedros Adhanom Ghebreyesus and President Carlos Alvarado Quesada of Costa Rica launched the initiative at a digital event on Friday 29 May, together with the support of a large number of Member States and international organisation. The ‘Solidarity Call to Action’ targets governments, public and private sector funders of research, pharmaceutical industry, as well as researchers themselves.
Marisol Touraine, Chair of the Unitaid Executive Board and former French health minister said, “Equitable access to better medicines, tests and preventive methods is at the heart of Unitaid’s work – not just for COVID-19 but for HIV, tuberculosis, malaria and other diseases.” She continues, “We very much support the call for non-exclusive and global voluntary licensing through the Unitaid-established and supported Medicines Patent Pool, as well as through other mechanisms such as the UN Technology Bank-WHO TechAccess Partnership.”
Speaking at the launch, Dr Philippe Duneton, Unitaid Executive Director a.i., said. “Voluntary pooling is an important step in towards equitable access to COVID-19 medicines and tests. Intellection property rights are not the problem here, it is the way in which they are used. We expect the pharmaceutical industry to turn IP rights into solutions. Unitaid has created and supported MPP, and it has shown the way for the HIV response; this model is also key for the COVID-19 response”. He continues, “Global threats need global solutions. Equitable access to vaccines, diagnostics and therapeutics is  key to ending this pandemic, and what’s more they also need to be affordable.”…
25 May 2020
Unitaid greets new Korean-led initiative to improve the global response to infectious diseases
Geneva –  Unitaid welcomes the launch of the Support Group for Global Infectious Disease Response (G4IDR), an initiative led by the Republic of Korea that seeks to capitalize on lessons learned from the COVID-19 pandemic. The Geneva-based group convenes several countries and will collaborate with the World Health Organization (WHO) and global health organizations including Unitaid.
Is it part of the wider ‘Group of Friends of Solidarity for Global Health Security’ launched on 12 May 2020 at the UN Headquarters in New York, USA.
The Geneva G4IDR initiative was launched by H.E. Mrs Kang Kyung-wha, Minister of Foreign Affairs of the Republic of Korea. Mrs Kang emphasised the role of global institutions in tackling global challenges and said that she hoped the G4IDR Support Group, “will play an important role in facilitating and coordinating cooperation between countries and health organizations, eventually strengthening the global response not only to COVID-19 but to future global health crises that can strike next.”…
 
 
Vaccination Acceptance Research Network (VARN)  [to 30 May 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.
 
 
Vaccine Confidence Project  [to 30 May 2020]
http://www.vaccineconfidence.org/
Latest News & Archive
Feature
First measles, now COVID-19 – are outbreaks finally moving the dial on vaccine hesitancy?
May 2020
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 30 May 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
 
 
Wellcome Trust  [to 30 May 2020]
https://wellcome.ac.uk/news
Explainer | 29 May 2020
How can we get effective treatments for COVID-19?
From repurposed drugs to new therapies – researchers are working at incredible speed to find the best ways to treat COVID-19 patients.
 
 
The Wistar Institute   [to 30 May 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.
 
 
WFPHA: World Federation of Public Health Associations  [to 30 May 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.
 
 
World Organisation for Animal Health (OIE)   [to 30 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 30 May 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.
 
 
BIO    [to 30 May 2020]
https://www.bio.org/press-releases
Press Releases
Dr. Anthony Fauci, Dr.Moncef Slaoui and Top COVID-19 Thought Leaders Take Stage During BIO Digital Week
May 28, 2020
Anthony Fauci, M.D., National Institute of Allergy and Infectious Diseases Director and Moncef Slaoui, Ph.D., U.S. Operation Warp Speed Chief Advisor will speak on a special plenary session on Tuesday, June 9 during BIO Digital, a virtual conference…
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 30 May 2020]
http://www.dcvmn.org/
No new digest content identified.
 
 
IFPMA   [to 30 May 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Pharma partners in efforts to give coronavirus vaccine for everyone

28 May 2020
Geneva, 28 May 2020. IFPMA has today updated the world’s media on the biopharmaceutical industry’s unprecedented efforts, many of them in collaboration with others, to speed up research and development for a new COVID-19 vaccine. The body representing the global biopharmaceutical industry also highlighted at the briefing that plans are underway to scale up manufacturing at risk even though it is not sure yet which, if any, vaccines in development will be found to be safe and effective. Such investments decisions are unprecedented and demonstrate companies are not taking a “business as usual” approach in their response to the global pandemic.

The industry reaffirmed its acute awareness of the enormous responsibility it has to patients and society to bring its knowledge and expertise to bear, in collaboration and in partnership with others, in finding a coronavirus vaccine and thereby live up to the commitment it is giving to deliver safe, quality, effective, and affordable COVID-19 vaccines to all.

A new vaccine to protect people from COVID-19 holds the greatest promise of ending the pandemic, but there are no guarantees that one will be found. The biopharmaceutical industry is working at unparalleled speed and sparing no resources to develop safe and effective COVID-19 vaccines in record time. As of 27 May 2020, the WHO reports there are currently 10 candidate vaccines in clinical evaluation and 115 candidate vaccines in pre-clinical evaluation. Several biopharmaceutical companies are researching vaccine candidates and are collaborating in the sharing of existing technologies that can be leveraged to allow a rapid upscale of production once a vaccine candidate is identified. Companies are also sharing technologies that act as an adjuvant which can boost the effectiveness of a potential vaccine. [Overview of industry activities].

Thomas Cueni, IFPMA Director General, is acutely aware of the challenges: “Not only does the science have to be on our side if we are to quickly find a coronavirus vaccine, but we also have to find ways of being able to produce hundreds of millions, possible billions of doses of the new vaccine. Then people need to be vaccinated in sufficient numbers to protect whole communities. And, all the while, we should continue to produce existing vaccines”.

He admits the task in hand is larger than any attempted before and beyond the power of any single entity. Cueni explains: “The only way to deliver on our promise of safe, equitable, affordable coronavirus vaccines is for science and collaboration on a global scale to prevail. Be in no doubt, our member companies are fully engaged in the race to find a vaccine. We are fully committed to playing our full role within existing partnerships, such as ACT Accelerator and Gavi, on the basis that we wholeheartedly embrace the goal of providing new coronavirus vaccines for all”.

Looking to the upcoming Global Vaccine Summit on 4 June, and Gavi, the Vaccine Alliance replenishment, Cueni declared: “While we should give our undevoted attention to ending the COVID-19 pandemic, we must not fall into the trap of forgetting the need for ongoing immunization efforts to continue as well as being very vigilant in tracking any future virus”. He confirms that the biopharmaceutical industry will continue its 20-year history of working in partnership with Gavi, founded in 2000, that has led to nearly half the world’s children being protected against deadly and debilitating infectious diseases”.

Pharma industry updates advice on engaging with healthcare professionals as countries emerge from COVID-19 lockdown

28 May 2020
Geneva, 28 May 2020: As countries lift lockdown restrictions, the international pharma industry body, IFPMA, provides its members with ethical considerations on when and how to resume in-person meetings with healthcare practitioners and other stakeholders within the healthcare system.

During the COVID-19 pandemic, biopharmaceutical companies proactively interrupted face-to-face interactions between their representatives and physicians, in order to protect patients, healthcare professionals, and their own employees, and have replaced in-office visits and face-to-face congresses with online platforms, virtual meetings, webinars, etc.

Maintaining dialogue and scientific exchange with the medical community is critical to inform physicians about new possible treatments, alternative treatment protocols, product supply or safety/efficacy data. This meaningful engagement is even more critical during the COVID-19 pandemic, as physicians contend with the many medical questions of how the virus could affect their patients’ existing treatments and at the same time need to remain informed about general scientific information and treatment options. “During the lockdown, employees have stepped away from healthcare sites to limit the spread of the virus and protect patients, while maintaining remote interactions to continue to share scientific knowledge” explains Rady Johnson, Chair of the IFPMA Ethics and Business Integrity Committee, and Chief Compliance, Quality and Risk Officer at Pfizer. Looking to the future, he adds: “Maintaining productive dialogue and scientific exchange with the medical community is central to ensuring that all patients, COVID and non-COVID, receive the treatments needed to support their overall health and well-being. But even as doors open up, we want to preserve that dialogue and partnership without risk to the safety of patients, customers, our employees and communities. We remain committed to appropriately engaging healthcare professionals in-person when it is safe to do so, alongside our continued use of remote interaction channels”.

In these unprecedented times and the high level of unpredictability, the biopharmaceutical industry has found that its recently launched Ethos[1] has been indispensable in helping provide the necessary framework to anchor ethical decision-making, where no specific rules could have previously been anticipated. This principles-driven approach will continue to guide IFPMA members’ conduct as they adapt to the evolving COVID-19 operating environment…
 
 
ICBA – International Council of Biotechnology Associations   [to 30 May 2020]
https://internationalbiotech.org/
News
No new digest content identified.
 
 
PhRMA    [to 30 May 2020]
http://www.phrma.org/
Selected Press Releases, Statements
No new digest content identified.
 
 
Industry Watch   [to 30 May 2020]
:: Moderna Announces First Participants in Each Age Cohort Dosed in Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
May 29, 2020
:: Johnson & Johnson Receives Positive CHMP Opinion for Janssen’s Investigational Preventive Ebola Vaccine Regimen
May 29, 2020
 

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

American Journal of Tropical Medicine and Hygiene
Volume 102, Issue 5, May 2020
http://www.ajtmh.org/content/journals/14761645/102/5

Editorial
The Importance of Diagnostic Testing during a Viral Pandemic: Early Lessons from Novel Coronavirus Disease (COVID-19)
Philip J. Rosenthal
Pages: 915–916

American Journal of Tropical Medicine and Hygiene
Volume 102, Issue 5, May 2020
http://www.ajtmh.org/content/journals/14761645/102/5

Perspective Piece
oa How Is the World Responding to the Novel Coronavirus Disease (COVID-19) Compared with the 2014 West African Ebola Epidemic? The Importance of China as a Player in the Global Economy
Elisa M. Maffioli
Pages: 924–925

American Journal of Tropical Medicine and Hygiene
Volume 102, Issue 5, May 2020
http://www.ajtmh.org/content/journals/14761645/102/5

Articles
oa Safety and Immunogenicity of Different Formulations of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico: Final Results after 3 Years of Follow-Up from a Randomized, Placebo-Controlled Phase I Study
Clemente Diaz, Michael Koren, Leyi Lin, Luis J. Martinez, Kenneth H. Eckels, Maribel Campos, Richard G. Jarman, Rafael De La Barrera, Edith Lepine, Irma Febo, David W. Vaughn, Todd M. Wilson, Robert M. Paris, Alexander C. Schmidt and Stephen J. Thomas
Pages: 951–954
https://doi.org/10.4269/ajtmh.19-0461

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 30 May 2020)

Harnessing health plan enrollee data to boost membership in patient-powered research networks
Patient-powered research networks (PPRNs) have been employing and exploring different methods to engage patients in research activities specific to their conditions. One way to intensify patient engagement is …
Authors: Xiaoxue Chen, Abiy Agiro, W. Benjamin Nowell, Sara Loud, Robert McBurney, Kalen Young, Rebecca Sutphen, Elizabeth Bourquardez Clark, Cristina M. Burroughs, Jeffrey R. Curtis, Antoine G. Sreih, Peter A. Merkel and Kevin Haynes
Citation: BMC Health Services Research 2020 20:462
Content type: Research article
Published on: 25 May 2020

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 30 May 2020)

The quadrivalent HPV vaccine is protective against genital warts: a meta-analysis
The quadrivalent human papillomavirus (HPV) vaccine has been assumed to give protection against genital warts (GW) as well as cervical cancer. Our main question was whether HPV vaccine has any effects on the p…
Authors: Anita Lukács, Zsuzsanna Máté, Nelli Farkas, Alexandra Mikó, Judit Tenk, Péter Hegyi, Balázs Németh, László Márk Czumbel, Sadaeng Wuttapon, István Kiss, Zoltán Gyöngyi, Gábor Varga, Zoltán Rumbus and Andrea Szabó
Citation: BMC Public Health 2020 20:691
Content type: Research article
Published on: 28 May 2020

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 30 May 2020)

Full vaccination coverage among children aged 12–23 months in Ethiopia: a systematic review and meta-analysis
Vaccination is one of the most cost-effective means of public health interventions to prevent childhood deaths from infectious diseases. Although several fragmented studies have been conducted concerning full …
Authors: Daniel Bekele Ketema, Moges Agazhe Assemie, Alehegn Aderaw Alamneh, Muluneh Alene, Kassahun Yawukal Chane, Yoseph Merkebe Alamneh, Molla Yigzaw Birhanu and Animut Alebel
Citation: BMC Public Health 2020 20:777
Content type: Research article
Published on: 24 May 2020

Clinical Trials
Volume 17 Issue 3, June 2020
https://journals.sagepub.com/toc/ctja/17/3

Ethics
Economic vulnerability and payment for research participation
Luke Gelinas, Sarah A White, Barbara E Bierer
First Published February 17, 2020; pp. 264–272
Abstract
There has been significant analysis of the ethical and regulatory issues involved with paying research participants, but less attention has been focused specifically on paying economically vulnerable individuals and the unique challenges it may present. This is important, as individuals of lower socio-economic standing are present in all disease groups and study populations. Moreover, clinical research is often conducted in economically under-developed locales, such as lower- or middle-income countries as well as impoverished locales of otherwise wealthy nations (such as, for example, rural Appalachia in the United States). Is it ethical to offer payment in such contexts? What are the ethical considerations relevant for determining payment rates and practices to individuals who are economically vulnerable? We offer an analysis of these issues, focusing on four unique areas of concern: (1) whether the risk of undue influence is greater for economically vulnerable individuals than for wealthier ones; (2) whether payment unacceptably raises the risk of ‘unjust influence’ or disproportionate representation of poor people in clinical research; (3) the positive reasons in favor of paying economically vulnerable people that stem from the ethical value of fairness; and (4) appropriate compensation rates for economically vulnerable populations. Our analysis supports the position that payment to economically vulnerable populations is ethically justified and indeed desirable when certain conditions are met.

Contemporary Clinical Trials
Volume 91 April 2020
https://www.sciencedirect.com/journal/contemporary-clinical-trials/vol/91/suppl/C

Special Interest Papers
Review article Open access
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
Mobile sensors offer enormous potential for the collection of informative clinical endpoints in clinical trials to support regulatory decision making and product labelling. There are currently no specific guidelines on the information needed to enable regulators to review and accept proposed endpoints derived from mobile sensors for use in drug development trials.
M.K. Walton, J.C. Cappelleri, B. Byrom, J.C. Goldsack, … M. Daumer
Article 105962

Epidemics
Volume 31 June 2020
https://www.sciencedirect.com/journal/epidemics/vol/31/suppl/C

Research article Open access
The time scale of asymptomatic transmission affects estimates of epidemic potential in the COVID-19 outbreak
Sang Woo Park, Daniel M. Cornforth, Jonathan Dushoff, Joshua S. Weitz
Article 100392

Genome Medicine
https://genomemedicine.biomedcentral.com/articles
[Accessed 30 May 2020]

Comment
The Medical Genome Initiative: moving whole-genome sequencing for rare disease diagnosis to the clinic
Authors: Christian R. Marshall, David Bick, John W. Belmont, Stacie L. Taylor, Euan Ashley, David Dimmock, Vaidehi Jobanputra, Hutton M. Kearney, Shashikant Kulkarni and Heidi Rehm
Citation: Genome Medicine 2020 12:48
Content type: Comment
Published on: 27 May 2020
Abstract
Clinical whole-genome sequencing (WGS) offers clear diagnostic benefits for patients with rare disease. However, there are barriers to its widespread adoption, including a lack of standards for clinical practice. The Medical Genome Initiative consortium was formed to provide practical guidance and support the development of standards for the use of clinical WGS.

Human Vaccines & Immunotherapeutics (formerly Human Vaccines)
Volume 16, Issue 5, 2020
http://www.tandfonline.com/toc/khvi20/current

Special Issue: Vaccine Acceptance
Editorials
Building vaccine acceptance through communication and advocacy
Kristen A. Feemster
Pages 1004-1006 | Published online: 13 May 2020
…Conclusion
The key issues for increasing the number of vaccinated people worldwide, especially children, is to increase the supply of available vaccines, assure funding and affordability for lower-income countries, improve distribution and storage networks, assure the availability of healthcare workers to administer vaccines, improve the ability of the population to access vaccination centers, and minimize refusal / hesitation to maximize acceptability of vaccines.
It is noteworthy that among these key issues, all involve physical activities except for the final issue, which is the subject of this Special Issue. Vaccine acceptance / hesitation / refusal is unique in being a state of mind for the potential vaccinee or caregiver, such that different methods must be applied to improve acceptability. The ability of workers in the field to improve acceptability will be directly reflected in increased vaccinations with concomitant reductions in morbidity and mortality from vaccine-preventable diseases. This is a major public health challenge for the coming decade and beyond, which also will be very important for the success of new vaccines in the development pipeline.

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 30 May 2020]

Psychological status and behavior changes of the public during the COVID-19 epidemic in China
A cluster of pneumonia cases were reported by Wuhan Municipal Health Commission, China in December 2019. A novel coronavirus was eventually identified, and became the COVID-19 epidemic that affected public hea…
Authors: Xi Liu, Wen-Tao Luo, Ying Li, Chun-Na Li, Zhong-Si Hong, Hui-Li Chen, Fei Xiao and Jin-Yu Xia
Citation: Infectious Diseases of Poverty 2020 9:58
Content type: Research Article
Published on: 29 May 2020

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 30 May 2020]

Tuberculosis infection prevention and control: why we need a whole systems approach
Infection prevention and control (IPC) measures to reduce transmission of drug-resistant and drug-sensitive tuberculosis (TB) in health facilities are well described but poorly implemented. The implementation …
Authors: Karina Kielmann, Aaron S. Karat, Gimenne Zwama, Christopher Colvin, Alison Swartz, Anna S. Voce, Tom A. Yates, Hayley MacGregor, Nicky McCreesh, Idriss Kallon, Anna Vassall, Indira Govender, Janet Seeley and Alison D. Grant
Citation: Infectious Diseases of Poverty 2020 9:56
Content type: Opinion
Published on: 25 May 2020

JAMA
May 26, 2020, Vol 323, No. 20, Pages 1989-2104
https://jamanetwork.com/journals/jama/currentissue

Viewpoint
COVID-19: Beyond Tomorrow
The Potential Effects of Coronavirus on National Health Expenditures
Sherry Glied, PhD; Helen Levy, PhD
has active quiz has multimedia has audio
JAMA. 2020;323(20):2001-2002. doi:10.1001/jama.2020.6644
This Viewpoint discusses the likely effects of the COVID-19 pandemic on US health care spending and on estimates of its share of gross domestic product (GDP).
Audio Interview: COVID-19 and US Health Care Spending

JAMA
May 26, 2020, Vol 323, No. 20, Pages 1989-2104
https://jamanetwork.com/journals/jama/currentissue

COVID-19: Beyond Tomorrow
The Business of Medicine in the Era of COVID-19
David M. Cutler, PhD; Sayeh Nikpay, PhD; Robert S. Huckman, PhD
free access has active quiz
JAMA. 2020;323(20):2003-2004. doi:10.1001/jama.2020.7242
This Viewpoint discusses the shifting landscape of health care financing, regulation, and delivery as a result of the coronavirus pandemic, and discusses regulatory and other changes that need to be in place if telehealth and physician practice and hospital mergers become the “new normal” once the pandemic is controlled.

JAMA
May 26, 2020, Vol 323, No. 20, Pages 1989-2104
https://jamanetwork.com/journals/jama/currentissue

Securing the Safety Net and Protecting Public Health During a PandemicMedicaid’s Response to COVID-19
Chethan Bachireddy, MD, MSc; Christopher Chen, MD, MBA; Mohammad Dar, MD
free access
JAMA. 2020;323(20):2009-2010. doi:10.1001/jama.2020.4272
This Viewpoint reviews options legally available to state Medicaid programs to respond to the COVID-19 pandemic, including increasing coverage of the uninsured, expanding telehealth capabilities, removing financial barriers to testing and treatment, and easing limits on drug prescriptions.

JAMA
May 26, 2020, Vol 323, No. 20, Pages 1989-2104
https://jamanetwork.com/journals/jama/currentissue

Social Media and Emergency Preparedness in Response to Novel Coronavirus
Raina M. Merchant, MD, MSHP; Nicole Lurie, MD, MSPH
free access has active quiz
JAMA. 2020;323(20):2011-2012. doi:10.1001/jama.2020.4469
This Viewpoint discusses the ways social media can be used as a critical tool in managing the COVID-19 outbreak, such as by directing users to trusted sources and counteracting misinformation, and how it can transform aspects of preparedness and response for the future.

Journal of Empirical Research on Human Research Ethics
Volume 15 Issue 3, July 2020
http://journals.sagepub.com/toc/jre/current

Ethical Issues in Informed Consent
Dynamic Consent: An Evaluation and Reporting Framework
Megan Prictor, Megan A. Lewis, Ainsley J. Newson, Matilda Haas, Sachiko Baba, Hannah Kim, Minori Kokado, Jusaku Minari, Fruzsina Molnár-Gábor, Beverley Yamamoto, Jane Kaye, Harriet J. A. Teare
First Published November 15, 2019; pp. 175–186

Journal of Empirical Research on Human Research Ethics
Volume 15 Issue 3, July 2020
http://journals.sagepub.com/toc/jre/current

Automating Dynamic Consent Decisions for the Processing of Social Media Data in Health Research
Chris Norval, Tristan Henderson

First Published November 6, 2019; pp. 187–201

Journal of Empirical Research on Human Research Ethics
Volume 15 Issue 3, July 2020
http://journals.sagepub.com/toc/jre/current

Providing Incentives to Youth Participants in Research: A Literature Review
Jenny L. Afkinich, Dara R. Blachman-Demner

First Published December 12, 2019; pp. 202–215

Journal of Evidence-Based Medicine
Volume 13, Issue 2 Pages: 89-177 May 2020
https://onlinelibrary.wiley.com/toc/17565391/current

REVIEW
Clinical research methods for treatment, diagnosis, prognosis, etiology, screening, and prevention: A narrative review
Xiaomei Yao et al
Pages: 130-136
First Published: 22 May 2020

Journal of Evidence-Based Medicine
Volume 13, Issue 2 Pages: 89-177 May 2020
https://onlinelibrary.wiley.com/toc/17565391/current

COMMENTARY
Open Access
Challenges and strategies to research ethics in conducting COVID‐19 research
Xitao Ma et al
Pages: 173-177
First Published: 22 May 2020

Journal of Pharmaceutical Policy and Practice
https://joppp.biomedcentral.com/
[Accessed 30 May 2020]

Pharmacist intervention amid the coronavirus disease 2019 (COVID-19) pandemic: from direct patient care to telemedicine
Authors: Ali Elbeddini and Aniko Yeats
Content type: Commentary
27 May 2020

The Lancet
May 30, 2020 Volume 395 Number 10238 p1669-1738, e98-e100
https://www.thelancet.com/journals/lancet/issue/current

Editorial
COVID-19 in Africa: no room for complacency
The Lancet

The Lancet
May 30, 2020 Volume 395 Number 10238 p1669-1738, e98-e100
https://www.thelancet.com/journals/lancet/issue/current

Articles
Triple combination of interferon beta-1b, lopinavir–ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial
Ivan Fan-Ngai Hung, et al

The Lancet
May 30, 2020 Volume 395 Number 10238 p1669-1738, e98-e100
https://www.thelancet.com/journals/lancet/issue/current

Use of renin–angiotensin–aldosterone system inhibitors and risk of COVID-19 requiring admission to hospital: a case-population study
Francisco J de Abajo, et al on behalf of the MED-ACE2-COVID19 study group

The Lancet
May 30, 2020 Volume 395 Number 10238 p1669-1738, e98-e100
https://www.thelancet.com/journals/lancet/issue/current

Estimating excess 1-year mortality associated with the COVID-19 pandemic according to underlying conditions and age: a population-based cohort study
Amitava Banerjee,et al
Open Access

The Lancet
May 30, 2020 Volume 395 Number 10238 p1669-1738, e98-e100
https://www.thelancet.com/journals/lancet/issue/current

Public Health
Voluntary collective isolation as a best response to COVID-19 for indigenous populations? A case study and protocol from the Bolivian Amazon
Hillard S Kaplan, et al

The Lancet
May 30, 2020 Volume 395 Number 10238 p1669-1738, e98-e100
https://www.thelancet.com/journals/lancet/issue/current

Viewpoint
Access to lifesaving medical resources for African countries: COVID-19 testing and response, ethics, and politics
Matthew M Kavanagh, et al
… Every life has equal worth. Yet global allocation of testing and other resources currently means that some are forced to wait, while those ahead in the global procurement line take precedence. In 2020, we have the opportunity to learn from past mistakes by countering market forces, thus ensuring that lives on the African continent count equally. Doing so will take both moral clarity and political courage.

Nature
Volume 581 Issue 7809, 28 May 2020
http://www.nature.com/nature/current_issue.html

Human resource
In this week’s issue, four papers provide in-depth insights gleaned from the Genome Aggregation Database (gnomAD). A successor to 2016’s ExAC database, which held the exomes of 60,706 individuals, gnomAD aggregates 125,748 exomes and 15,708 whole-genome sequences. This increase in size and scope has allowed the gnomAD Consortium to catalogue not only single nucleotide variants between individuals but also more complex structural variants, made up of 50 or more nucleotides. In the main paper, Konrad Karczewski and colleagues review the database and explore variants that can inactivate protein-coding genes. In a second paper, Beryl Cummings and co-workers show that RNA expression data can be used to guide variant interpretation. In another paper, Eric Minikel and colleagues probe how the gnomAD data might help to identify genetic targets for drugs. And in the fourth paper, Ryan Collins and co-workers set out a catalogue of 433,371 structural variants and analyse them for their influence on physiological traits.

Nature
Volume 581 Issue 7809, 28 May 2020
http://www.nature.com/nature/current_issue.html

Editorial | 27 May 2020
Coronavirus misinformation needs researchers to respond
Researchers must be transparent and acknowledge what is known and what isn’t.
World View | 19 May 2020

Nature
Volume 581 Issue 7809, 28 May 2020
http://www.nature.com/nature/current_issue.html

To set coronavirus policy, model lives and livelihoods in lockstep
Economists must improve tools to weigh trade-offs between health and wealth, says Andy Haldane.

The Genome Aggregation Database (gnomAD)
Article | 27 May 2020 | Open Access

The mutational constraint spectrum quantified from variation in 141,456 humans
A catalogue of predicted loss-of-function variants in 125,748 whole-exome and 15,708 whole-genome sequencing datasets from the Genome Aggregation Database (gnomAD) reveals the spectrum of mutational constraints that affect these human protein-coding genes.
Konrad J. Karczewski, Laurent C. Francioli[…] & Daniel G. MacArthur

The Genome Aggregation Database (gnomAD)
Article | 27 May 2020 | Open Access

Article | 27 May 2020 | Open Access
A structural variation reference for medical and population genetics
A large empirical assessment of sequence-resolved structural variants from 14,891 genomes across diverse global populations in the Genome Aggregation Database (gnomAD) provides a reference map for disease-association studies, population genetics, and diagnostic screening.
Ryan L. Collins, Harrison Brand[…] & Michael E. Talkowski

The Genome Aggregation Database (gnomAD)
Article | 27 May 2020 | Open Access

Article | 27 May 2020 | Open Access
Transcript expression-aware annotation improves rare variant interpretation
A novel variant annotation metric that quantifies the level of expression of genetic variants across tissues is validated in the Genome Aggregation Database (gnomAD) and is shown to improve rare variant interpretation.
Beryl B. Cummings, Konrad J. Karczewski[…] & Daniel G. MacArthur

The Genome Aggregation Database (gnomAD)
Article | 27 May 2020 | Open Access

Analysis | 27 May 2020 | Open Access
Evaluating drug targets through human loss-of-function genetic variation
Analysis of predicted loss-of-function variants from 125,748 human exomes and 15,708 whole genomes in the Genome Aggregation Database (gnomAD) provides a roadmap for human ‘knockout’ studies and a guide for future research into disease biology and drug-target selection.
Eric Vallabh Minikel, Konrad J. Karczewski[…] & Daniel G. MacArthur