Vaccines and Global Health: The Week in Review :: 17 April 2021

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

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

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

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

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– Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

Secretary-General, at Economic and Social Council Forum, Spells Out Priority Areas for Urgent Action in Response to, Recovery from COVID-19

Milestones :: Perspectives :: Research

 

Secretary-General, at Economic and Social Council Forum, Spells Out Priority Areas for Urgent Action in Response to, Recovery from COVID-19
SG/SM/20681 12 April 2021
Following are UN Secretary-General António Guterres’ remarks to the opening of the 2021 Economic and Social Council Forum on Financing for Development, in New York today:

Financing for Development in the context of the COVID-19 pandemic means an unprecedented effort to mobilize resources and political will.  Since the pandemic began one year ago, no element of our multilateral response has gone as it should.

More than 3 million people have lost their lives.  Some 120 million people have fallen back into extreme poverty, while the equivalent of 255 million full-time jobs have been lost.  We have seen the worst recession in 90 years.  And the crisis is far from over.  Indeed, the speed of infections is now even increasing.

We need to heed the lessons now if we are to reverse these dangerous trends, prevent successive waves of infection, avoid a lengthy global recession and get back on track to fulfil the 2030 Agenda for Sustainable Development and the Paris Agreement on climate change.  Unity and solidarity will save lives and prevent communities and economies from falling into catastrophic debt and dysfunction.

Advancing an equitable global response and recovery from the pandemic is putting multilateralism to the test.  So far, it is a test we have failed.  The vaccination effort is one example.  Just 10 countries across the world account for around 75 per cent of global vaccinations.  Many countries have yet to start vaccinating their health-care workers and most vulnerable citizens.  A global vaccine gap threatens everyone’s health and well-being.  The virus is dangerous everywhere if it spreads unchecked anywhere.  And global value chains do not function if one link is broken.

Some estimates put the global cost of unequal access and vaccine hoarding at more than $9 trillion.  The same lack of solidarity means that some countries have mobilized relief packages worth trillions of dollars, while many developing countries face insurmountable debt burdens that will put the Sustainable Development Goals (SDGs) completely out of reach if not corrected.

Even in 2019, before the pandemic, 25 countries spent more on debt service than on education, health, and social protection combined.  Now, many Governments face an impossible choice between servicing debt or saving lives.  But in reality, there is just one choice:  to take action to avert a global debt crisis.

Inequalities are also growing within countries, as women and girls and the most vulnerable groups have been hit the hardest by the pandemic.  Nearly 170 million children around the world have been out of school for a year.  We face a global education crisis with a devastating long-term impact on individuals and their communities, which could contribute to inequality across the generations.

We are here today to set the course for an equitable, sustainable and resilient response and recovery from COVID-19.  I call for urgent action in six areas.

First, vaccines must be available to all countries in need.  We must close the funding gap of the COVAX facility.  To end the pandemic for good, we need equitable access to vaccines for everyone, everywhere…

Global leaders rally to accelerate access to COVID-19 vaccines for lower-income countries

Milestones :: Perspectives :: Research

 

COVID 19 Vaccines – Access

Global leaders rally to accelerate access to COVID-19 vaccines for lower-income countries
:: The “One World Protected” Event, hosted today by the United States and Gavi, the Vaccine Alliance, launched a campaign to raise US$ 2 billion for the global fight against COVID-19.

 

:: The additional funding from donors and countries with MDB support will enable the Gavi COVAX Advance Market Commitment (AMC) to secure 1.8 billion doses of COVID-19 vaccines for 92 lower-income countries by the end of the year.

:: At the event, governments and private sector partners made early pledges worth nearly US$ 400 million and committed to donate millions of COVID-19 vaccine doses to COVAX to benefit the most vulnerable in lower-income economies.

 

:: The new campaign will culminate in June 2021, at the Gavi COVAX AMC Summit, which will be hosted by Prime Minister Yoshihide Suga of Japan.

Washington, D.C./Geneva, 15 April 2021 – World leaders joined forces today at the “One World Protected” event to take stock of progress in global efforts to ensure equitable access to COVID-19 vaccines and seek ways to further accelerate vaccination. The event, hosted by US Secretary of State Antony J. Blinken, Acting Administrator of USAID Gloria Steele, and Chair of the Board of Gavi José Manuel Barroso, was joined by more than 200 participants, including leaders from government, business, civil society, and partner organizations across the globe.

In a vital step on the path to providing global protection against COVID-19, a new Investment Opportunity was unveiled, launching a campaign to raise an additional $US 2 billion from donors and the private sector for the Gavi COVAX Advance Market Commitment (AMC). With this funding, the COVAX mechanism can lock in up to 1.8 billion vaccine doses for people at risk in 92 lower-income economies and accelerate coverage. The campaign will also aim to mobilize $US 1 billion in cost sharing from countries through domestic resource mobilization and the support of multilateral development banks (MDBs)…

 

New commitments to the Gavi COVAX AMC
At the event today, a number of donor governments announced significant new commitments worth a total of almost $400 million towards the 2021 goal. This includes:

:: SEK 2.25 billion (US$ 258.1 million) pledge from Sweden for the International Finance Facility for Immunisation (IFFIm), Gavi’s innovative financing mechanism.
:: EUR 40 million (US$ 47.2 million) from the Netherlands for the Gavi COVAX AMC
:: DKK 50 million (US$ 8 million) from Denmark for the Gavi COVAX AMC
:: CHF 100,000 (US$ 106,000) from Liechtenstein for the Gavi COVAX AMC
:: EUR 678,125 (US$ 800,188) from Portugal for the Gavi COVAX AMC

In addition to these, private sector partners and foundations also mobilised significant new resources for the Gavi COVAX AMC:
:: The Bill & Melinda Gates Foundation announced that US$ 30 million of its contribution to the Gavi Matching Fund would be made available to match private sector contributions to the COVAX AMC.
:: Gates Philanthropy Partners have mobilized US$ 18 million.
:: A Swiss foundation wishing to remain anonymous also offered CHF 15 million (US$ 15.9 million) to incentivize private sector giving.
:: Google.org have committed US$ 2.5 million to the COVAX AMC and in parallel will launch a global campaign incentivising employees to contribute directly to Gavi. In addition, Google.org has donated US$ 15 million in Ad credits to Gavi. Longer term, Google.org engineers will also support Gavi’s broader innovation agenda.
:: The Asia Philanthropic Circle joined as a new partner and pledged US$ 1.5 million.
:: The Visa Foundation joined as a new partner and pledge US$1.5 million. Visa will also match employee donations to Gavi dollar for dollar through Visa’s employee donation matching program.
:: A group of Portuguese philanthropists and partners (Fidelidade Group, Luz Saúde Hospitals and Multicare Insurance, Manuel António da Mota Foundation, the Ismaili Imamat and Caixa Geral de Depósitos) collectively committed EUR 1.5 million (US$ 1.8 million).
:: Vaccine Forward (including AB SKF) have contributed SEK 2 million (US$ 230,000) to-date, with the aim to mobilise up to US$10 million.

The cash contributions from Google, the Asia Philanthropic Circle and the Visa Foundation will be matched by the Bill & Melinda Gates Foundation.

“Equitable distribution of vaccines offers the best prospect for ending the pandemic, kick-staring economic recovery and overcoming the vaccine divide between those with access to COVID-19 vaccines and those without,” said José Manuel Barroso, Chair of the Board of Gavi. “We are not there yet: while COVAX has begun delivering to AMC participating economies, we urgently need additional funding to protect those most at risk from the virus. I applaud leaders for stepping up and showing their support today as we embark on this vital fundraising effort.”

 

First commitments to dose sharing through COVAX
In addition to financial support, new pledges in support of dose sharing through COVAX were announced at the event. Under this scheme, countries will be able to donate millions of doses of their own COVID19 vaccines to COVAX in an act of global solidarity. As part of this effort, New Zealand committed today that it will donate more than 1.6 million doses of vaccines to COVAX, with a focus on the Pacific region. France welcomed the finalization of a new agreement between COVAX and Team Europe on the provision of doses which will ensure the first French and European donations via COVAX will materialize shortly…

Remarks by World Bank Group President David Malpass at the Gavi “One World Protected” COVAX Advance Market Commitment Investment Opportunity Launch

Milestones :: Perspectives :: Research

 

COVID Vaccine – Response Financing

Remarks by World Bank Group President David Malpass at the Gavi “One World Protected” COVAX Advance Market Commitment Investment Opportunity Launch
Date: April 15, 2021 Type: Speeches and Transcripts
Secretary Blinken, UN Deputy Secretary-General Mohammed, Dr. Barroso, Dr. Berkley, and Excellencies.

I am pleased to be participating today. As a founding partner of Gavi, the World Bank Group is a key partner at the country level in strengthening routine immunization, and we are now partnering with you on the largest vaccination effort in history in order to stop the COVID-19 pandemic. Our goal, from the beginning of the vaccination planning effort almost a year ago, has been to facilitate a system that can provide the billions of safe vaccinations needed in the near term and lay the groundwork for longer-term prevention of COVID.

Including our Board’s expected approvals tomorrow, the World Bank will have committed $2 billion for COVID vaccines across 17 countries, with the total expected to reach at least $4 billion and 50 countries by mid-year.  This financing can be used by countries to make payments to COVAX, including the purchase of additional doses beyond the COVAX-provided 20% as countries aim for higher levels of coverage.

Our financing is available for countries to spend quickly after Board approval, often in a matter of days or weeks. It supports vaccine purchases and also supports deployment – the important business of getting shots into arms. For the poorer countries, much of the financing is on grant or highly concessional terms. The World Bank is working to further increase our available country financing to use all available resources for the vaccination effort.

While COVAX has received financial commitments, accelerated encashment is needed to help COVAX complete the contracting needed to provide its 20% and higher levels. With $4 billion in World Bank funds to be in place by mid-year, we are seeking to purchase through COVAX, especially for the poorer countries, to the extent COVAX has access to supplies.

We need to recognize that the supply of vaccines may be an even more binding constraint than cash flow. Many countries now have dollars available to spend on doses, but rapid deliveries aren’t available.

I would like to underline here the importance for countries that have the prospect of excess vaccine supplies to release them as soon as possible.  Because the capacity to deliver and administer shots is limited, it’s imperative that increased supplies begin to flow to developing countries.

 

We also need suppliers, countries, and their development partners to distinguish between contracts, options, letters of intent, best efforts, and Memoranda of Understanding.

These transparency steps are necessary so that financing can be directed more effectively, and countries can plan for receipt and deployment of vaccines. They are also critical to enable private sector investments to expand supply over the medium and long term. At IFC, we have a $4b Global Health Platform to support efforts to close gaps for essential health equipment and supplies, including vaccines, but effective use of this funding depends on more information about expected supply and demand.

We are working intensively on deployment, to achieve rapid and safe injection of vaccines. The COVID-19 vaccine campaign will be unlike any prior vaccination effort – the sheer volume of people, doses, locations, and human resources involved in the exercise will challenge the most resilient of systems, and even the best-laid vaccine deployment plans will be seriously tested.

Our collaboration with GAVI on COVAX and other ACT-A partners has been strong throughout the crisis and shows how we complement each other’s strengths. A robust rollout of vaccines is an integral part of the recovery and can also contribute to future preparedness.  We have worked with Gavi, Global Fund, WHO and UNICEF to help governments assess their readiness. The assessments showed that much more is needed in the medium-term to build resilience of health systems. World Bank and MDB financing will play an important role in filling these gaps.

The World Bank Group is placing a special focus on the poorest countries, and is committed to working with all partners toward rapid, fair and equitable access to vaccines. Transparency and international cooperation are key elements of the road forward, and we look forward to continuing these vital vaccination efforts. Thank you.

COVID Vaccines – IP, TRIPS+

Milestones :: Perspectives :: Research

 

COVID Vaccines – IP, TRIPS+

Open Letter: Former Heads of State and Nobel Laureates Call on President Biden To Waive Intellectual Property Rules for COVID Vaccines
People’s Vaccine Alliance

Dear President Biden,
We the undersigned former Heads of State and Government and Nobel Laureates are gravely concerned by the very slow progress in scaling up global COVID-19 vaccine access and inoculation in low- and middle-income countries.

The world saw unprecedented development of safe and effective vaccines, in major part thanks to U.S. public investment. We all welcome that vaccination rollout in the U.S. and many wealthier countries is bringing hope to their citizens.

Yet for the majority of the world that same hope is yet to be seen. New waves of suffering are now rising across the globe. Our global economy cannot rebuild if it remains vulnerable to this virus.
But we are encouraged by news that your Administration is considering a temporary waiver of World Trade Organization (WTO) intellectual property rules during the COVID-19 pandemic, as proposed by South Africa and India, and supported by more than 100 WTO member states and numerous health experts worldwide.

A WTO waiver is a vital and necessary step to bringing an end to this pandemic. It must be combined with ensuring vaccine know-how and technology is shared openly. This can be achieved through the World Health Organization COVID-19 Technology Access Pool, as your Chief Medical Advisor, Dr. Anthony Fauci, has called for. This will save lives and advance us towards global herd immunity.

These actions would expand global manufacturing capacity, unhindered by industry monopolies that are driving the dire supply shortages blocking vaccine access. 9 in 10 people in most poor countries may well go without a vaccine this year. At this pace, many nations will be left waiting until at least 2024 to achieve mass COVID-19 immunization, despite what the limited, while welcome, COVAX initiative is able to offer.

These moves should be accompanied by coordinated global investment in research, development, and manufacturing capacity to tackle this pandemic and prepare us for future ones, as part of a more robust international health architecture. If this last year has taught us anything, it is that threats to public health are global, and that strategic government investment, action, global cooperation, and solidarity are vital. The market cannot adequately meet these challenges, and neither can narrow nationalism.

The full protection of intellectual property and monopolies will only negatively impact efforts to vaccinate the world and be self-defeating for the U.S. Given artificial global supply shortages, the U.S. economy already risks losing $1.3 trillion in GDP this year. Were the virus left to roam the world, and even if vaccinated, people in the U.S. would continue to be exposed to new viral variants.

Mr. President, our world learned painful lessons from unequal access to lifesaving treatments for diseases such as HIV. By supporting a TRIPS waiver, the U.S. will provide an example of responsible leadership at a time when it is needed most on global health — as it has done so before on HIV, saving millions of lives. Your support in rallying allies and all countries to follow your lead will also be essential.

With your leadership, we can ensure COVID-19 vaccine technology is shared with the world. Supporting the emergency waiver of COVID-19 related intellectual property rules will give people around the globe a chance to wake up to a world free from the virus. We need a people’s vaccine.

Many of us know, first-hand, the reality of political office and the pressures, challenges and constraints of leadership. However, we believe this would be an unparalleled opportunity for the U.S. to exercise solidarity, cooperation and renewed leadership, one we hope will inspire many more to do the same.

Please take the urgent action that only you can, and let this moment be remembered in history as the time we chose to put the collective right to safety for all ahead of the commercial monopolies of the few.

Let us now ensure an end to this pandemic for us all. As advocates for global and equitable vaccine access, we remain ready to support and add our voices to your efforts on this front.

Signatories at title link above…
[More than 170 former heads of state and government and Nobel laureates, including former Prime Minister of the United Kingdom Gordon Brown, former President of Colombia Juan Manuel Santos, former President of Liberia Ellen Johnson Sirleaf, former President of France François Hollande and Nobel Laureates Professor Joseph Stiglitz and Professor Francoise Barre-Sinoussi]

 

::::::

WTO Chair Summary following “COVID-19 and Vaccine Equity: What Can the WTO Contribute?”
14 April 2021
[See WTO below in Announcements for detail]

IFPMA statement at WTO event “COVID-19 and Vaccine Equity: What can the WTO Contribute”
15 April 2021
[See IFPMA below in Announcements for detail]

COVID 19 Impacts

Milestones :: Perspectives :: Research

 

COVID 19 Impacts

New Global Fund Report Shows Massive Disruption to Health Care Caused by COVID-19 in Africa and Asia
13 April 2021
GENEVA – A new report by the Global Fund to Fight AIDS, Tuberculosis and Malaria shows COVID-19 has massively disrupted health systems and health service delivery for HIV, TB and malaria in low- and middle-income countries in Africa and Asia in 2020. The report highlights the urgent need to scale up the adaptive measures that health facilities adopted to continue the fight against HIV, TB, malaria, to ramp up delivery of critical supplies for the COVID-19 response, and prevent health care systems and community responses from collapse.

Through programmatic spot-checks recording information from 502 health facilities in 32 countries in Africa and Asia between April and September 2020, the Global Fund has assembled a snapshot of the extent of the disruption to health services for HIV, TB and malaria, and of how health facilities have responded.

“This snapshot underscores the scale of the challenge,” said Peter Sands, Executive Director of the Global Fund. “HIV prevention has been knocked backwards. With the dramatic drop in case management for malaria, we face a real risk for a spike in mortality. Much of the progress we’ve made to close the gap on finding “missing” people with TB has been reversed. The stark truth is that we will see more incremental deaths from HIV, TB and malaria in 2021 as a consequence of the disruption caused by COVID-19 in 2020.”

The data collected shows that for April to September 2020, compared to the same six-month period in 2019:
:: HIV testing fell 41%.
:: TB referrals – where patients suspected of having TB are referred to the next step of diagnosis and treatment – declined by 59%.
:: Malaria diagnoses fell by 31%.
:: Antenatal care visits fell by 43%.

The spot-checks also highlighted a critical lack of tests, treatments and PPE needed to fight COVID-19, particularly in Africa:
:: Only 45% of health facilities had enough essential PPE items for its health workers, including masks, disinfectant, gloves and hand sanitizer.
:: Across the 24 countries in Africa that were surveyed, only 11% of health facilities could conduct COVID-19 antigen rapid diagnostic tests, and only 8% could conduct polymerase chain reaction (PCR) tests.

However, the snapshot also shows that countries that implemented adaptive measures to counter the impact of COVID-19 on health service continuity fared better than those that did not adapt. More than two-thirds (68%) of facilities surveyed adopted at least one adaptive measure, such as dispensing long-term supplies of medicines for HIV and TB to patients, or switching to a door-to-door delivery system for mosquito nets and preventative malaria medicines. These successful adaptations to service disruption by COVID-19 need to be further investigated, scaled up and tailored to local contexts.

The Global Fund has already deployed nearly US$1 billion to fight COVID-19 and mitigate the impact on HIV, TB and malaria in more than 100 countries. Through the ACT-Accelerator, the global collaboration to ensure the accelerated launch and equitable deployment of tools to fight COVID-19, the Global Fund is now the primary channel for providing grant support to low- and middle-income countries on tests, treatments (including medical oxygen), PPE and health system strengthening. For the Global Fund to fulfil its responsibility to the ACT-Accelerator and regain lost progress against HIV, TB and malaria, an additional US$10 billion is needed. To date in 2021, the Global Fund has raised US$3.7 billion.

“In most low- and middle-income countries, the crisis is far from over, with infections and deaths from COVID-19 continuing to increase, and the knock-on impact on HIV, TB and malaria continuing to escalate ” said Peter Sands, Executive Director of the Global Fund. “To regain the ground lost on the three epidemics in 2020 and to step up the fight against COVID-19, we have to massively scale up adaptation programs, increase access to COVID-19 tools, and shore up systems for health so they don’t collapse.”
Report: The impact of COVID-19 on HIV, TB and malaria services and systems for health: a snapshot from 502 health facilities across Africa and Asia

COVID-19 Data Explorer: Global Humanitarian Operations

Milestones :: Perspectives :: Research

 

OCHA:: HDX
COVID-19 Data Explorer: Global Humanitarian Operations
COVID-19 Vaccine Roll-out
Apr 17, 2021 | COVAX (WHO,GAVI,CEPI), UNDESA, Press Reports | DATA
Global COVID-19 Figures: 130M total confirmed cases; 2.9M total confirmed deaths
Global vaccines administered: 730M
Number of Countries: 26
COVAX First Allocations (Number of Doses): 73M
COVAX Delivered (Number of Doses): 12M
Other Delivered (Number of Doses): 12M
Total Delivered (Number of Doses): 24M
Total Administered (Number of Doses): 7.0M

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

Milestones :: Perspectives :: Research

Coronavirus [COVID-19] – WHO
Public Health Emergency of International Concern (PHEIC)
https://www.who.int/emergencies/diseases/novel-coronavirus-2019

Weekly Epidemiological and Operational updates
Last update: 17 April 2021
Confirmed cases :: 139 501 934 [week ago: 134 308 070] [two weeks ago: 129 902 402]
Confirmed deaths :: 2 992 193 [week ago: 2 907 944 [two weeks ago: 2 831 815]
Countries, areas or territories with cases :: 223

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Weekly operational update on COVID-19 – 12 April 2021
Overview
In this edition of the Weekly Operational Update on COVID-19, highlights of country-level actions and WHO support to Member States include:
:: COVID-19 vaccines now in all countries of the Eastern Mediterranean Region
:: Kingdom of Tonga receives COVID-19 vaccine doses from the COVAX Facility
:: Restoring essential services after massive fire in the world’s largest refugee camp: Cox’s Bazar, Bangladesh
:: Strengthening COVID-19 surveillance and contact tracing in Armenia
:: Second WHO training in infodemic management: open call for applications
:: Experiences of long-term care facilities in managing the COVID-19 pandemic
:: The Strategic Preparedness and Response Plan (SPRP) 2021 resource requirements and progress made to continue investing in the COVID-19 response and for building the architecture to prepare for, prevent and mitigate future health emergencies
:: Updates on WHO/PAHO procured items, Partners Platform, implementation of the Unity Studies, and select indicators from the COVID-19 Monitoring and Evaluation Framework

Weekly epidemiological update on COVID-19 – 13 April 2021
Overview
Globally, new COVID-19 cases rose for a seventh consecutive week, with over 4.5 million new cases reported in the last week. The number of new deaths increased for the fourth consecutive week, increasing by 7% compared to last week, with over 76 000 new deaths reported.
In this edition, a special focus update is provided on SARS-CoV-2 variants.

WHO – COVID Vaccines EUAL, Prequalification

Milestones :: Perspectives :: Research

 

WHO – COVID Vaccines EUAL, Prequalification

Draft landscape and tracker of COVID-19 candidate vaccines
16 April 2021 | Publication
The COVID-19 candidate vaccine landscape and tracker database compiles detailed information on COVID-19 vaccine candidates in development.
The landscape is updated regularly – twice a week (Tuesday and Friday, 17:00 CET).
Download: https://cdn.who.int/media/docs/default-source/blue-print/12.03.2021-novel-coronavirus_landscape_covid-19.xlsx.zip?sfvrsn=c2a25511_3&download=true

 

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Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 14 April 2021
For 19 vaccine candidates, presents Manufacturer, Name of Vaccine, NRA of Record, Platform, EOI Accepted Status, Pre-submission Meeting Held Status, Dossier Accepted for Review, Status of Assessment; Anticipated/Completed Decision Date
[click on the link above for full scale view]

COVID Vaccine Developer/Manufacturer Announcements [organizations from WHO EUL/PQ listing above]

Milestones :: Perspectives :: Research

 

COVID Vaccine Developer/Manufacturer Announcements [organizations from WHO EUL/PQ listing above]

 

AstraZeneca
Press Releases – No new digest announcements identified

Bharat Biotech, India
Press Releases – No new digest announcements identified

BioCubaFarma – Cuba
Últimas Noticias
Actualización del proceso de vacunación en Cuba durante los ensayos clínicos en curso
14/04/2021

…Como parte del Ensayo clínico Fase III con Soberana 02, se ha aplicado la segunda dosis a 4 534 sujetos y en el Ensayo Clínico Fase III con Abdala, 22 108 sujetos, ya tienen aplicada la segunda dosis.

 

CanSinoBIO
News – No new digest announcements identified

Clover Biopharmaceuticals – China
News – No new digest announcements identified

 

Gamaleya National Center
Latest News and Events – No new digest announcements identified [See Russia/RFID below]

IMBCAMS, China
Home – No new digest announcements identified

 

Janssen/JNJ
Press Releases
Apr 14, 2021 United States
Johnson & Johnson Statement on CDC Advisory Committee Meeting on Company COVID-19 Vaccine
NEW BRUNSWICK, N.J., April 14, 2021 – The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) convened today to consider reports of an extremely rare disorder involving blood clots in combination with low platelets observed in a small number of individuals following vaccination with the Johnson & Johnson COVID-19 vaccine.
“The safety and well-being of the people who use our products is our number one priority, and we strongly support awareness of the signs and symptoms of this extremely rare event to ensure the correct diagnosis, appropriate treatment and expedited reporting by health care professionals,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “We continue to believe in the positive benefit-risk profile of our vaccine. We value the consideration of the Advisory Committee, and we will continue to collaborate with medical experts and global health authorities, including the CDC, U.S. Food and Drug Administration (FDA), European Medicines Agency and the World Health Organization, as we work toward continuing vaccinations to end the global pandemic.”
Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine. The Company has made the decision to proactively delay the rollout of our vaccine in Europe and pause vaccinations in all Janssen COVID-19 vaccine clinical trials while we update guidance for investigators and participants.
The CDC and FDA have made information available about proper recognition and management due to the unique treatment required with this type of blood clot. The health authorities advise that people who have received our COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.

 

Moderna
Press Releases
April 14, 2021
Moderna Announces Clinical Progress from its Industry-Leading mRNA Vaccine Franchise and Continues Investments to Accelerate Pipeline Development
:: CMV 7-month data shows all GMT measures at or above CMV seropositive baselines; pivotal Phase 3 study of at least 8,000 participants expected to begin in 2021
:: First interim analysis of Phase 1 RSV vaccine candidate (mRNA-1345) shows >11- fold increase in RSV neutralizing antibodies in younger adults (ages 18-49 years); both 50 μg and 100 μg dose levels generally well-tolerated
:: Phase 1 clinical study of mRNA flu vaccine candidate expected to begin in 2021
:: Phase 1 study evaluating HIV mRNA vaccines with novel strategy expected to begin in 2021

April 13, 2021
Moderna Provides Clinical and Supply Updates on COVID-19 Vaccine Program Ahead of 2nd Annual Vaccines Day
:: Phase 3 COVE Study: Updated cases show continued strong efficacy, including greater than 90% against cases of COVID-19 and greater than 95% against severe cases of COVID-19, with approximately 6 months median follow-up post dose 2
:: Antibody persistence data out to 6 months published in The New England Journal of Medicine
:: New preclinical data shows variant-specific booster vaccine candidates (mRNA-1273.351 and mRNA-1273.211) increase neutralizing titers against SARS-CoV-2 variants of concern
:: Supply Update: As of April 12, approximately 132 million doses have been delivered globally

 

Novavax
Press Releases
Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations
– Study to explore heterologous regimen of COVID-19 vaccines from different manufacturers
– Will assess potential for flexibility in the delivery of COVID-19 vaccines
GAITHERSBURG, Md., April 14, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its participation in a newly expanded investigator-initiated Phase 2 clinical trial called Comparing COVID-19 Vaccine Schedule Combinations – Stage 2 (Com-COV2), to be conducted by the University of Oxford and supported by the UK Vaccines Taskforce. Novavax’ recombinant protein vaccine candidate, NVX-CoV2373, is one of four COVID-19 vaccines that will be studied to evaluate the potential for combined regimens that mix vaccines from different manufacturers to achieve immune protection against COVID-19…

 

Pfizer
Recent Press Releases – No new digest announcements identified

 

Serum Institute of India
NEWS & ANNOUNCEMENTS – No new digest announcements identified

 

Sinopharm/WIBPBIBP
News – No new digest announcements identified

 

Sinovac
Press Releases – No new digest announcements identified

 

Vector State Research Centre of Viralogy and Biotechnology
Home – No new digest announcements identified

Zhifei Longcom, China
[Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.]
[No website identified]

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

Milestones :: Perspectives :: Research

 

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

 

White House [U.S.]
Briefing Room
Press Briefing by White House COVID-19 Response Team and Public Health Officials
April 16, 2021 • Press Briefings

Fact Sheet: Biden Administration Announces $1.7 Billion Investment to Fight COVID-19 Variants
April 16, 2021 • Statements and Releases
…Today’s announcement includes:
:: $1 billion to expand genomic sequencing:  This funding will help CDC, states, and other jurisdictions improve their capacity to identify COVID mutations and monitor circulation of variants. Specifically, it will allow CDC and jurisdictional health departments to conduct, expand, and improve activities to sequence genomes and identify mutations in SARS-CoV-2. Much of this work is done through CDC partnerships with the laboratory community and through state laboratories, and the funding will support the collection of COVID specimens, the sequencing of COVID viruses, and the sharing of the resultant data. A state-by-state breakdown of the initial $240 million in jurisdictional funding support is below.
:: $400 million to support innovation initiatives including the launch of new innovative Centers of Excellence in Genomic Epidemiology:  The funding will establish six Centers of Excellence in Genomic Epidemiology. These centers of excellence will operate as partnerships between state health departments and academic institutions, and today’s funding will fuel cutting-edge research into genomic epidemiology. For example, the partnerships could focus on developing new genomic surveillance tools to better track pathogens of public health interest with the objective of developing surveillance methods to be used more widely in the public health system.  Areas of focus will likely include bioinformatic workflows and the critical integration of genomic and epidemiologic data.
:: $300 million to build and support a National Bioinformatics Infrastructure: One of the challenges of building out the nation’s sequencing capacity is having the data system necessary to quickly and effectively access information and turn it into concrete actions to prevent the spread of viruses. Experts use bioinformatics and complex computing to connect the dots between how pathogens spread and mutate to help solve outbreaks. This investment will support bioinformatics throughout the U.S. public health system, creating a unified system for sharing and analyzing sequence data in a way that protects privacy but allows more informed decisionmaking. This funding also will support training to increase sequencing in clinical settings and expand CDC’s Bioinformatics Fellowship program…

Press Briefing by White House COVID-19 Response Team and Public Health Officials
April 14, 2021 • Press Briefings

Press Briefing by Press Secretary Jen Psaki, NIAID Director and Chief Medical Advisor to the President Dr. Anthony Fauci, and COVID-19 Response Coordinator Jeff Zients, April 13, 2021
April 13, 2021 • Press Briefings

Statement from Jeff Zients, White House COVID-19 Response Coordinator on Johnson & Johnson Vaccine
April 13, 2021 • Statements and Releases

Press Briefing by White House COVID-19 Response Team and Public Health Officials
April 12, 2021 • Press Briefings

 

::::::

COVID Data Tracker April 3, 2021

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

Milestones :: Perspectives :: Research

 

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

 

European Medicines Agency
News & Press Releases
News: EMA starts review of VIR-7831 for treating patients with COVID-19 (new)
CHMP, Last updated: 15/04/202
EMA is reviewing currently available data on the use of the monoclonal antibody VIR-7831 (also known as GSK4182136) in the treatment of patients with COVID-19. EMA is starting this review to support national authorities who may decide on the use of this medicine for COVID-19 prior to marketing authorisation

 

News: AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets (new)
CHMP, Last updated: 14/04/2021

 

News: COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues (new)
PRAC, Last updated: 14/04/2021

 

European Commission
Statement 14 April 2021
Statement by President von der Leyen on developments in the Vaccines Strategy
The COVID-19 pandemic remains a severe threat to people’s health and livelihoods. We are in a race against time. The faster we reach our target of having 70% of adults in the European Union vaccinated, the better chances we have of containing the virus.
And the good news is: Vaccination is picking up speed across Europe! Member States have received over 126 million doses of vaccines as of yesterday. And I am happy to say that today we have reached 100 million vaccinations in the EU. This is a milestone that we can be proud of. Of these 100 million vaccinations, more than a quarter are second doses – which means that we have now more than 27 million people fully vaccinated.
This is good news. But as we can see with the announcement by Johnson & Johnson yesterday, there are still many factors that can disrupt the planned delivery schedule of vaccines. It is therefore important to act swiftly, anticipate and adjust whenever possible. We are doing everything in our power to support Europe’s vaccination roll-out, also by increasing the supply of vaccines in the coming weeks and months.
This is why I am pleased to announce that we have reached an agreement with BioNTech-Pfizer to, once again, speed up the delivery of vaccines. 50 million additional doses of BioNTech-Pfizer vaccines will be delivered in quarter 2 of this year, starting in April. Those 50 million doses were initially foreseen for delivery in the fourth quarter of 2021. Now, they are available in quarter 2.
This will bring the total doses delivered by BioNTech-Pfizer to 250 million doses in the second quarter. These doses will be distributed pro-rata to the population, among all the Member States. This will substantially help consolidate the roll-out of our vaccination campaigns. I want to thank BioNTech-Pfizer. It has proven to be a reliable partner. It has delivered on its commitments, and it is responsive to our needs. This is to the immediate benefit of EU citizens.
But let me also focus on the medium term. To prepare for the future, we are drawing the lessons from the first phase of our answer to the pandemic. It is clear that to defeat the virus decisively, we will need to be prepared for the following: At a certain point in time, we might need booster jabs to reinforce and prolong immunity; and if escape-variants occur, we will need to develop vaccines that are adapted to new variants; and we will need them early and in sufficient quantities. Having this in mind we need to focus on technologies that have proven their worth. mRNA vaccines are a clear case in point.
Based on all this, we are now entering into a negotiation with BioNTech-Pfizer for a third contract. This contract will foresee the delivery of 1.8 billion doses of vaccine over the period of 2021 to 2023. And it will entail that not only the production of the vaccines, but also all essential components, will be based in the EU.
The negotiations we are launching today – and hope to conclude very rapidly – are a further important step in Europe’s response to the pandemic. Other contracts, with other companies, may follow. We are in this together. And we will win this fight against the pandemic together…Thank you.

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

Milestones :: Perspectives :: Research

 

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

CEPI and the African Union join forces to boost African vaccine R&D and manufacturing
Oslo, Norway, and Addis Ababa, Ethiopia; April 13, 2021—The Coalition for Epidemic Preparedness Innovations (CEPI) and the African Union Commission have today announced the signing of an memorandum of understanding, which aims to strengthen ties between the organisations and the Africa CDC—a specialised institution of the African Union responsible for the prevention and control of diseases in Africa—to enhance vaccine R&D and manufacturing in Africa.

This collaboration forms a major part of CEPI’s longer term epidemic and pandemic strategy, announced in March, 2021. As part of this strategy, CEPI aims to work with low-income and middle income countries to develop the infrastructure and expertise to undertake the epidemiological and clinical studies needed to advance vaccine development, support technology transfer, and develop national and regional manufacturing capacity that will enable these countries to take full ownership of their national health security.

Scope of the collaboration
As part of the expanded relationship, CEPI, the African Union, the Africa CDC will work to:
:: Strengthen pandemic and outbreak preparedness on the continent, building on key lessons from the COVID-19 and the procurement and distribution of vaccines through COVAX and African Vaccine Acquisition Task Team (AVATT), established and endorsed by the AU Bureau of Heads of State and Government on 20th of August, 2020;
:: Invest in vaccine R&D innovations to enable faster and easier production of vaccines in Africa;
:: Invest in capacity building and training to foster the development of local expertise needed to boost vaccine R&D and manufacturing in Africa;
:: Strengthen institutions that enhance enabling science need for vaccine development—for example, through investments in regional laboratory and research hubs across Africa
:: Build partnerships that enable the sustainable expansion of vaccine manufacturing in Africa…

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

Milestones :: Perspectives :: Research

 

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

 

Russia: Sputnik V – “the first registered COVID-19 vaccine”
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
RDIF, GL Rapha and ISU ABXIS to cooperate for production of Sputnik V in Korea
Press release, 15.04.2021
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), GL Rapha, one of the leading South Korean bio-tech companies, and ISU ABXIS (a subsidiary of ISU GROUP) have signed an agreement for technology transfer and production of the Russian Sputnik V vaccine against coronavirus in Korea…

Production of Sputnik V launched in Serbia
Press release, 14.04.2021

The Gamaleya Center statement
Press release, 14.04.2021
A comprehensive analysis of adverse events during clinical trials and over the course of mass vaccinations with the Sputnik V vaccine showed that there were no cases of cerebral venous sinus thrombosis (CVST)…

Sputnik V vaccine authorized in India
Press release, 12.04.2021

POLIO Public Health Emergency of International Concern (PHEIC)

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 13 April 2021
:: Dr Hamid Jafari, Director of Polio Eradication for WHO’s Eastern Mediterranean Region, declared Somalia’s outbreak of circulating vaccine-derived poliovirus type 3 (cVDPV3) closed a full 28 months after this strain of polio was last detected in Somalia. Read more

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
:: Afghanistan: four cVDPV2 cases
:: Pakistan: one WPV1 positive environmental sample
:: Burkina Faso: one cVDPV2 case
:: Congo: one cVDPV2 case
:: Côte d’Ivoire: one cVDPV2 case
:: Democratic Republic of the Congo: one cVDPV2 case
:: Guinea: five cVDPV2 cases
:: Liberia: one cVDPV2 positive environmental sample
:: Mali: two cVDPV2 cases
:: Senegal: one cVDPV2 case
:: Sierra Leone: two cVDPV2 cases
:: Yemen: three cVDPV1 cases

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

WHO/OCHA Emergencies

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

WHO Grade 3 Emergencies [to 17 Apr 2021]

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

::::::

WHO Grade 2 Emergencies [to 17 Apr 2021]
Iraq
:: WHO confirms the safety and efficacy of COVID-19 vaccines and urges Iraqis to register and vaccinate to help defeat the pandemic
Baghdad – 11 April 2021. The World Health Organization (WHO) in Iraq refutes the fabricated statement recently circulated in an unofficial social media platform to undermine the citizens’ confidence in the safety and efficacy of COVID-19 vaccines…

Niger
:: Le Niger a reçu 355 000 doses du vaccins Aztra Zeneca contre la COVID-19 expédiés par le mécanisme COVAX
16 avril 2021

Afghanistan – No new digest announcements identified [Last apparent update: 5 July 2020]
Angola – No new digest announcements identified [Last apparent update: 16 March 2021]
Burkina Faso – No new digest announcements identified [Last apparent update: 01 avril 2021]
Burundi – No new digest announcements identified [Last apparent update: 04 July 2019]
Cameroon – No new digest announcements identified [Last apparent update: 22 August 2019]
Central African Republic – No new digest announcements identified [Last apparent update: 12 June 2018]
Ethiopia – No new digest announcements identified [Last apparent update: 22 August 2019]
Iran floods 2019 – No new digest announcements identified [Last apparent update: 2 March 2020]
Libya – No new digest announcements identified [Last apparent update: 7 October 2019]
Malawi – No new digest announcements identified [Last apparent update: 07 April 2021]
Measles in Europe – No new digest announcements identified [Last apparent update: 16-12-2020]
MERS-CoV – No new digest announcements identified [Last apparent update: 8 July 2019]
Mozambique – No new digest announcements identified [Last apparent update: 03 November 2020]
Myanmar – No new digest announcements identified [Last apparent update: 29 March 2021]
occupied Palestinian territory – No new digest announcements identified [Last apparent update: 4 September 2019]
HIV in Pakistan – No new digest announcements identified [Last apparent update: 27 August 2019]
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements
Sudan – No new digest announcements identified [Last apparent update: 24 June 2020]
Ukraine – No new digest announcements identified [Last apparent update: 1 May 2019]
Zimbabwe – No new digest announcements identified [Last apparent update: 10 May 2019]

::::::

WHO Grade 1 Emergencies [to 17 Apr 2021]

Chad – No new digest announcements identified [Last apparent update: 30 June 2018]
Djibouti – No new digest announcements identified [Last apparent update: 25 novembre 2020]
Kenya – No new digest announcements identified [Last apparent update: 06 March 2021]
Mali – No new digest announcements identified [Last apparent update: 3 May 2017]
Namibia – viral hepatitis – No new digest announcements identified [Last apparent update: 20 July 2018]
Tanzania – No new digest announcements identified [Last apparent update: 21 October 2020]

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

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

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

 

WHO & Regional Offices [to 17 Apr 2021]

WHO & Regional Offices [to 17 Apr 2021]
16 April 2021 Departmental news
Update of the WHO guidance on the treatment of drug susceptible tuberculosis

16 April 2021 Statement
Global Advisory Committee on Vaccine Safety (GACVS) review of latest evidence of rare adverse blood coagulation events with AstraZeneca COVID-19 Vaccine (Vaxzevria and Covishield)

15 April 2021 Departmental news
Global shortage of innovative antibiotics fuels emergence and spread of drug-resistance

14 April 2021 News release
New WHO Global Compact to speed up action to tackle diabetes

14 April 2021 Departmental news
Digital technologies for health financing:

14 April 2021 News release
WHO and the International Organisation of the Francophonie (IOF) sign Memorandum of Understanding to strengthen access to health in Francophone countries

14 April 2021 Departmental news
WHO calls for comprehensive, equitable access to healthcare for every Chagas disease patient

13 April 2021 Departmental news
Benefits of continuing to provide life-saving HIV services outweigh the risk of COVID-19 transmission by 100 to 1

12 April 2021 Departmental news
US$ 1.4 trillion lost every year to tobacco use – New tobacco tax manual shows ways to save lives, money and build back better after COVID-19

 

::::::

Weekly Epidemiological Record, Vol. 96, No. 15, pp. 117–124 16 April 2021
:: Progress in monitoring immunization safety –worldwide, 2010–2019

 

::::::

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

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
:: Apply all tools, take urgent action to prevent further COVID-19 infections: WHO 16 April 2021 SEAR/PR/1752

WHO European Region EURO
:: Surging pandemic surpasses 1 million deaths in the WHO European Region 15-04-2021
:: Youth organizations, have your say! Shape tomorrow by speaking up today! 15-04-2021
:: New WHO Centre of Excellence for Quality of Care and Patient Safety opens in Athens 15-04-2021
:: Reducing harm due to alcohol: success stories from 3 countries 15-04-2021
:: Alcohol policies for the European Region: new WHO research reveals eastern Member States are leading the way 15-04-2021

WHO Eastern Mediterranean Region EMRO
:: WHO confirms the safety and efficacy of COVID-19 vaccines and urges Iraqis to register and vaccinate to help defeat the pandemic 11 April 2021.

WHO Western Pacific Region
No new digest content identified

CDC/ACIP [U.S.] [to 17 Apr 2021]

CDC/ACIP [U.S.] [to 17 Apr 2021]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements

 

ACIP Virtual Emergency Meeting – April 23, 2021
A virtual emergency meeting will be held to disc ss Janssen (Johnson & Johnson) COVID-19 vaccine on 11:00 a.m. to 5:00 p.m. ET
No registration is required for either meeting.
Draft Agenda – May 5, 2021pdf icon
Webcast Link

 

ACIP Emergency Meeting of April 14, 2021
Agenda – April 14, 2021 pdf icon[1 page]
Presentation Slides: April 14, 2021

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
Tuesday, April 13, 2021
[Announcement ACIP Meeting of 14 April 2021]

China CDC

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

National Health Commission of the People’s Republic of China [to 17 Apr 2021]
http://en.nhc.gov.cn/
News
April 17: Daily briefing on novel coronavirus cases in China
On April 16, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 15 new cases of confirmed infections.

Mauritius receives first batch of COVID-19 vaccines from China
2021-04-16

China encourages voluntary COVID-19 vaccination: official
2021-04-12

Director of China CDC criticizes misleading accounts
2021-04-13
Gao Fu, director-general of Chinese Center for Disease Control and Prevention, has made it clear that boosting vaccine protection is a question of global concern, not only for China.
During a forum held on Saturday, Gao proposed upgrading immunization procedures or mixing doses using different technologies as ways to further improve vaccine effectiveness.
However, some media reports have misinterpreted his statement as claiming that Chinese vaccines do not have high efficacy rates, the scientist said.
“They (media reports) are misleading and have taken my words out of context,” Gao said during an interview with online media outlet Guancha.cn on Sunday.
“The World Health Organization requires all COVID-19 vaccines to have an efficacy rate of 50 percent or higher, and to be effective in preventing severe infections and deaths. All approved vaccines meet these standards,” he said…

COVID-19 herd immunity feasible in China, experts say
2021-04-12
Stronger effort needed to boost the public’s confidence about getting shots
Speeding up COVID-19 vaccinations to reach herd immunity in China will be a challenging but feasible task, health experts have said, calling for stronger efforts to raise public awareness about vaccines and make the inoculation process more convenient and considerate.
Vaccination distribution across the country has been gaining momentum in recent weeks, with nearly 165 million doses administered and daily inoculations exceeding 6 million doses on several occasions, official data showed.
But reaching the estimated herd immunity threshold of 70 to 80 percent is a formidable endeavor and will require innovative and concerted efforts, Gao Fu, director-general of the Chinese Center for Disease Control and Prevention, said during a forum in Chengdu, capital of Sichuan province, on Saturday.
“The mass vaccination drive faces constraints posed by limited inoculation sites and a lack of understanding of the significance and urgency to obtain vaccines, among other factors,” he said.
Public health experts have said that the country hopes to vaccinate 40 percent of the population by June or July, and 70 percent by the end of this year or early next year…

National Medical Products Administration – PRC [to 17 Apr 2021]
http://english.nmpa.gov.cn/news.html
News
China approves new COVID-19 vaccine for clinical trials
2021-04-12
The new recombinant COVID-19 vaccine, developed by the National Vaccine & Serum Institute, a R&D center of Sinopharm’s bioscience subsidiary the China National Biotec Group (CNBG), got approval from the National Medical Products Administration on April 9, the CNBG said on its official Weibo account on Saturday.

Organization Announcements

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

 

Paul G. Allen Frontiers Group [to 17 Apr 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
Your life history is written in your cells’ mutations
April 13, 2021
New study traces developmental history of the human body using small differences in DNA between each of our cells

 

BARDA – U.S. Department of HHS [to 17 Apr 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
News
No new digest content identified.

 

BMGF – Gates Foundation [to 17 Apr 2021]
https://www.gatesfoundation.org/ideas/media-center
Press Releases and Statements
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 17 Apr 2021]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

 

CARB-X [to 17 Apr 2021]
https://carb-x.org/
News
No new digest content identified.

 

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 17 Apr 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
:: Past weekly editions of Vaccines and Global Health: The Week in Review are available here.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 17 Apr 2021]
http://cepi.net/
Latest News
CEPI and the African Union join forces to boost African vaccine R&D and manufacturing
Oslo, Norway, and Addis Ababa, Ethiopia; April 13, 2021—The Coalition for Epidemic Preparedness Innovations (CEPI) and the African Union Commission have today announced the signing of an memorandum of understanding, which aims to strengthen ties between the organisations and the Africa CDC—a specialised institution of the African Union responsible for the prevention and control of diseases in Africa—to enhance vaccine R&D and manufacturing in Africa.
This collaboration forms a major part of CEPI’s longer term epidemic and pandemic strategy, announced in March, 2021. As part of this strategy, CEPI aims to work with low-income and middle-income countries to develop the infrastructure and expertise to undertake the epidemiological and clinical studies needed to advance vaccine development, support technology transfer, and develop national and regional manufacturing capacity that will enable these countries to take full ownership of their national health security.
Scope of the collaboration
As part of the expanded relationship, CEPI, the African Union, the Africa CDC will work to:
> Strengthen pandemic and outbreak preparedness on the continent, building on key lessons from the COVID-19 and the procurement and distribution of vaccines through COVAX and African Vaccine Acquisition Task Team (AVATT)—established and endorsed by the AU Bureau of Heads of State and Government on 20th of August, 2020.
> Invest in vaccine R&D innovations to enable faster and easier production of vaccines in Africa
> Invest in capacity building and training to foster the development of local expertise needed to boost vaccine R&D and manufacturing in Africa
> Strengthen institutions that enhance enabling science need for vaccine development—for example, through investments in regional laboratory and research hubs across Africa
> Build partnerships that enable the sustainable expansion of vaccine manufacturing in Africa…

 

DARPA – Defense Advanced Research Projects Agency [to 17 Apr 2021
https://www.darpa.mil/news
News
No new digest content identified.

 

Duke Global Health Innovation Center [to 17 Apr 2021]
https://dukeghic.org/
WEEKLY COVID VACCINE RESEARCH UPDATE
FRIDAY, April 2, 2021

 

EDCTP [to 17 Apr 2021]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
No new digest content identified.

 

Emory Vaccine Center [to 17 Apr 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Vaccine Initiative [to 17 Apr 2021]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 17 Apr 2021]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
April 16, 2021 – Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab

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

April 14, 2021 – FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19

April 13, 2021 – Coronavirus (COVID-19) Update: April 13, 2021
April 13, 2021 – Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

 

Fondation Merieux [to 17 Apr 2021]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

 

Gavi [to 17 Apr 2021]
https://www.gavi.org/
News Releases
15 April 2021
Global leaders rally to accelerate access to COVID-19 vaccines for lower-income countries
[See COVAX above for detail]

 

GHIT Fund [to 17 Apr 2021]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
No new digest content identified.

 

Global Fund [to 17 Apr 2021]
https://www.theglobalfund.org/en/news/
News & Stories
News
Indonesia, Germany and Global Fund Sign New Debt Swap Agreement to Fight TB
14 April 2021
Germany, Indonesia, and the Global Fund to Fight AIDS, Tuberculosis and Malaria today signed a new agreement that will increase support to tuberculosis programs in Indonesia. That will be achieved by converting €50 million of debt owed by Indonesia to Germany into investments in public health programs supported by the Global Fund in Indonesia.

News
New Global Fund Report Shows Massive Disruption to Health Care Caused by COVID-19 in Africa and Asia
13 April 2021
[See COVID 19 Impacts above for detail]

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 17 Apr 2021]
https://www.glopid-r.org/news/
News
Funding opportunity: Four calls for research on coronavirus variants with €123 million earmarked for research and innovation
13/04/2021
To address the growing threat of coronavirus variants, the European Commission has launched four calls for research to complement earlier actions…
Projects that receive funding are expected to:
:: establish multi-centre, regional or multinational cohorts, including beyond Europe’s borders;
:: further develop promising therapeutic or vaccine candidates against SARS-CoV-2/COVID-19;
:: strengthen research infrastructures to accelerate data sharing and research support.
The opening date is April 13, 2021 and the deadline for submissions is May 6, 2021.

 

Hilleman Laboratories [to 17 Apr 2021]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 17 Apr 2021]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
[Website not loading at inquiry]

 

IAVI [to 17 Apr 2021]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
April 10, 2021
Media Roundup: News Coverage Highlights Preliminary Data from IAVI G001 Clinical Trial

 

 

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

 

ICRC [to 17 Apr 2021]
https://www.icrc.org/en/whats-new
Selected News Releases, Statements, Reports
Egypt: the ICRC’s COVID-19 response
Since the outbreak of the Covid-19 pandemic in Egypt, the International Committee of the Red Cross (ICRC) has been in contact with relevant authorities as well its partner in the Red Cross and Red Crescent Movement, the Egyptian Red Crescent (ERC) co
14-04-2021 | Report

 

 

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
*News
Press Releases/Announcements
The WHO Global Diabetes Compact: an opportunity for lasting change
13 April 2021 – The Global Diabetes Compact is a major new WHO initiative which will unite people working in diabetes prevention, treatment and care, including people living with the condition, around a common agenda.

 

 

IFFIm
http://www.iffim.org/
Press Releases/Announcements
IFFIm Returns to Market with US$ 750 Million 5-year Oversubscribed Vaccine Bonds
14 Apr 2021
:: The issuance, IFFIm’s largest since 2006, will raise funding for Gavi’s core immunisation programmes and the Gavi COVAX Advance Market Commitment (AMC).
:: The Vaccine Bonds are backed by pledges from 10 sovereign donors, including recent new commitments from the United Kingdom and Norway.
:: Seth Berkley, Gavi CEO: “No one in the world is safe from the threat of COVID-19 until everyone is safe.”

 

IFRC [to 17 Apr 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Asia Pacific, Bangladesh, India, Pakistan
Record COVID surge crashes into South Asia
Kuala Lumpur/Delhi, 16 April 2021 – A humanitarian calamity is engulfing South Asia as COVID-19 skyrockets across several countries setting new records, with more than 200,000 people infected per day.  South Asia is fast becoming the new global epicenter …
16 April 2021

Asia Pacific, Indonesia, Timor-Leste
Indonesia-Timor Leste: Race to contain COVID-19 after deadly floods
Kuala Lumpur/Jakarta/Dili, 13 April 2021 – Urgent measures are needed to prevent COVID-19 outbreaks, while providing relief to thousands of people hit by record floods and mudslides that have claimed more than 200 lives, according to authorities in eas …
13 April 2021

Americas, Saint Vincent and the Grenadines
People affected by La Soufrière’s eruption are in urgent need of hygiene items, water, and COVID-19 protection kits
Kingston / Panama City, 11 April 2021 — The International Federation of Red Cross and Red Crescent Societies (IFRC) is working alongside the St. Vincent and the Grenadines Red Cross (SVGRC) to provide humanitarian aid to the population affected …
11 April 2021

 

Institut Pasteur [to 17 Apr 2021]
https://www.pasteur.fr/en/press-area
Press release
14.04.2021
Genetic admixture in the South Pacific: from Denisovans to the human immune response
Describing the genetic diversity of human populations is essential to improve our understanding of human diseases and their geographical distribution. However, the vast majority of genetic studies have been focused on populations of European ancestry, which represent only 16% of the global population. Scientists at the Institut Pasteur, Collège de France, and CNRS have looked at understudied human populations from the South Pacific, which are severely affected by a variety of diseases, including vector-borne infectious diseases such as Zika virus, dengue, and chikungunya, and metabolic diseases such as obesity and diabetes. Using genome sequencing of 320 individuals, the scientists have investigated how human populations have biologically adapted to the environments of the Pacific islands and how this has affected their current state of health. This study has also revealed hitherto unsuspected aspects of the history of human settlement in this region. This work is published in the April 14th, 2021 issue of Nature.

 

IRC International Rescue Committee [to 17 Apr 2021]
http://www.rescue.org/press-release-index
Media highlights [Selected]
No new digest content identified.

 

IVAC [to 17 Apr 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
Communicating about Vaccine Safety: “Pausing” Johnson & Johnson Vaccine Use
April 2021
This statement was developed by Molly Sauer, MPH and Rupali Limaye, PhD, MPH On Tuesday, April 13, 2021, federal health agencies called for a “pause” in use of the Johnson & Johnson COVID-19 vaccine after ongoing safety monitoring identified a rare blood clotting disorder in six people who had received the vaccine. Talking about vaccines […]

 

IVI [to 17 Apr 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

 

JEE Alliance [to 17 Apr 2021]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

Johns Hopkins Center for Health Security [to 17 Apr 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 17 Apr 2021]
http://www.msf.org/
Latest [Selected Announcements
Coronavirus COVID-19 pandemic
Failed COVID-19 response drives Brazil to humanitarian catastrophe
Press Release 15 Apr 2021  
:: After accounting for over a quarter of global COVID-19 deaths last week, Brazil does not have an effective plan in place to deal with the pandemic.
:: The pandemic in the country has become politicised, and the government has not adopted science-based measures to try to bring it under control.
:: MSF urges the Brazilian authorities to immediately convene a centralised and coordinated response to COVID-19.

 

National Academy of Medicine – USA [to 17 Apr 2021]
https://nam.edu/programs/
Selected News/Programs
NAM Publishes Letter Urging the Biden Administration to Immediately Allocate a Portion of U.S. COVID-19 Vaccine Supply to Countries in Need
April 13, 2021
Washington, DC — The National Academy of Medicine (NAM) has published a letter addressed to Xavier Becerra, Secretary of the U.S. Department of Health and Human Services, and Jeffrey Zients, White House Coronavirus Response Coordinator, urging the Biden administration to immediately allocate a portion of the U.S. COVID-19 vaccine supply to countries in need.

 

National Vaccine Program Office – U.S. HHS [to 17 Apr 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

 

NIH [to 17 Apr 2021]
http://www.nih.gov/news-events/news-releases
News Releases
Experimental antiviral for COVID-19 effective in hamster study
April 16, 2021 — MK-4482 shows potential to prevent and treat SARS-CoV-2 infection.

NIH-funded COVID-19 testing initiative aims to safely return children to in-person school
April 15, 2021 — New RADx-UP research effort combines testing and safety measures in underserved populations.

NIH closes enrollment in trial comparing COVID-19 treatment regimens
April 15, 2021 — Head-to-head trial unlikely to show difference between regimens.

NIH funds new influenza research network
April 14, 2021 — Sites will study the natural history, transmission, and pathogenesis of influenza.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has established a network of research sites to study the natural history, transmission and pathogenesis of influenza and provide an international research infrastructure to address influenza outbreaks. The program, called the Centers of Excellence for Influenza Research and Response (CEIRR), is expected to be supported for seven years by NIAID contracts to five institutions. Funding for the first year of the contracts will total approximately $24 million. CEIRR will replace the Centers of Excellence for Influenza Research and Surveillance (CEIRS) program, which was supported by contracts that concluded on March 31, 2021…

NIH trial of anti-CD14 antibody to treat COVID-19 respiratory disease begins
April 13, 2021 — The study will enroll between 300 and 350 hospitalized COVID-19 patients aged 18 years or older at 10 to 15 sites nationwide.

NIH experts discuss post-acute COVID-19
April 13, 2021 — Symptoms can be wide-ranging in severity and duration, and may affect numerous organ systems.

 

UN OCHA Office for the Coordination of Humanitarian Affairs [to 17 Apr 2021]
https://www.unocha.org/
Press Releases
No new digest content identified.

 

PATH [to 17 Apr 2021]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

 

Sabin Vaccine Institute [to 17 Apr 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 17 Apr 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
15 April 2021
Commission on Narcotic Drugs discusses how COVID-19 is impacting the world drug problem

14 April 2021
Former heads of state and Nobel laureates call on President Biden to waive intellectual property rules for COVID vaccines

12 April 2021
Wide range in access to HIV testing of babies in the Caribbean

 

UNDP United Nations Development Programme [to 17 Apr 2021]
http://www.undp.org/content/undp/en/home/presscenter.html
Latest from News Centre
UNDP and GISD Alliance Launch ‘SDG Investor Platform’ to unlock trillions on SDG-Aligned Investment Globally
UNDP and GISD Alliance launched the ‘SDG Investor Platform,’ an innovative tool to facilitate private sector investments that contribute to furthering the Sustainable Development Goals.
Posted on April 14, 2021

 

UNESCO [to 17 Apr 2021]
http://en.unesco.org/news
Selected Latest News
No new digest content identified.

 

UNHCR Office of the United Nations High Commissioner for Refugees [to 17 Apr 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected News Releases, Announcements
UNHCR’s Grandi and Pope Francis share a vision of global response to displacement based on solidarity and care
16 Apr 2021

 

 

Pakistan launches ‘drive’ to issue smartcards to registered Afghan refugees
15 Apr 2021

 

 

This Ramadan, UNHCR calls for solidarity with those hit hardest by the global pandemic
12 Apr 2021

 

UNICEF [to 17 Apr 2021]
https://www.unicef.org/media/press-releases
Selected Press Releases, Statements
Press release 04/12/2021
UNICEF providing humanitarian assistance to nearly 5,000 children affected by volcano eruption in Saint Vincent

 

Unitaid [to 17 Apr 2021]
https://unitaid.org/
Featured News
13 April 2021
Unitaid commemorates World Chagas Day with a new initiative to prevent mother-to-child transmission of the disease
:: Chagas disease affects between 6 and 7 million people worldwide and kills 10,000 people annually. In Latin America, it causes more deaths than any other parasitic disease including malaria. Patients infected with Chagas disease are at risk of severe COVID-19 manifestations.
:: At least two million women of child-bearing age are estimated to be chronically infected with Trypanosoma cruzi ( cruzi) and 5 to 10% of pregnant women with Chagas disease will transmit the infection to their new-borns.
:: On World Chagas Disease Day 2021 (14th of April), a new initiative co-financed by Unitaid and the Brazilian Ministry of Health aims to improve access to affordable diagnostics, better treatment, and comprehensive care for women and new-borns in four endemic countries: Brazil, Bolivia, Colombia, and Paraguay.

 

Vaccination Acceptance Research Network (VARN) [to 17 Apr 2021]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 17 Apr 2021]
http://www.vaccineconfidence.org/
News, Research and Reports
Coronavirus global impact
Launched April 2, 2020 and recurring every 3 days, Premise Data is utilizing its global network of Contributors to assess economic, social, and health sentiment surrounding the coronavirus (COVID-19).
[Data arrays do noy seem to loading]

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 17 Apr 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

 

Wellcome Trust [to 17 Apr 2021]
https://wellcome.ac.uk/news
News and reports
Q&A
An expert explains how to track coronavirus variants
Sonia Gonçalves
15 April 2021

 

The Wistar Institute [to 17 Apr 2021]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

 

WFPHA: World Federation of Public Health Associations [to 17 Apr 2021]
https://www.wfpha.org/
Latest News
No new digest content identified.

 

World Bank [to 17 Apr 2021]
http://www.worldbank.org/en/news/all
Selected News, Announcements
World Bank to Provide US$70 Million for COVID-19 Vaccination in El Salvador and Honduras
The Additional Financing for COVID-19 Emergency Response Projects will enable the purchase of vaccines and support national vaccination plans. WASHINGTON, D.C., April 16, 2021 – The World Bank Board of…
Date: April 16, 2021 Type: Press Release

The Gambia Secures More Funds for COVID-19 Vaccines
BANJUL, The Gambia, April 16, 2021—Today, the World Bank Board approved $8 million additional financing from the International Development Association (IDA) to provide The Gambia with safe and effective…
Date: April 16, 2021 Type: Press Release

What is IDA?
What is IDA?  The International Development Association (IDA) is one of the largest and most effective platforms for fighting extreme poverty in the world’s poorest countries. IDA is the part…
Date: April 15, 2021 Type: Factsheet

World Bank Launches Early IDA20 Replenishment to Help Poorest Countries Recover from the COVID-19 Crisis
Early replenishment due to scaled up pandemic response  WASHINGTON, April 15, 2021—The World Bank launched an early twentieth replenishment process of the International Development Association (IDA)…
Date: April 15, 2021 Type: Press Release

Key Facts: World Bank Group Vaccine Announcement
COVID-19 vaccines, alongside widespread testing, improved treatment and strong health systems are critical to save lives and strengthen the global economic recovery. To provide relief for vulnerable populations…
Date: April 15, 2021 Type: Factsheet

Remarks by World Bank Group President David Malpass at the Gavi “One World Protected” COVAX Advance Market Commitment Investment Opportunity Launch
Secretary Blinken, UN Deputy Secretary-General Mohammed, Dr. Barroso, Dr. Berkley, and Excellencies. I am pleased to be participating today. As a founding partner of Gavi, the World Bank Group is a key…
Date: April 15, 2021 Type: Speeches and Transcripts
[See Milestones above for detail]

Bangladesh Receives Over $1 Billion World Bank Financing for Vaccination and Responding to COVID-19 Pandemic
DHAKA, April 14, 2021 — The government of Bangladesh signed three financing agreements totaling $1.04 billion with the World Bank to respond to the COVID-19 pandemic and to build resilience to future crises…
Date: April 14, 2021 Type: Press Release

Bangladesh Receives Over $1 Billion World Bank Financing for Vaccination and Responding to COVID-19 Pandemic
DHAKA, April 14, 2021 — The government of Bangladesh signed three financing agreements totaling $1.04 billion with the World Bank to respond to the COVID-19 pandemic and to build resilience to future crises…
Date: April 14, 2021 Type: Press Release

Prioritizing the poorest and most vulnerable in West Africa: Togo’s Novissi platform for social protection uses machine learning, geospatial analytics, and mobile phone metadata for the pandemic response.
Challenge Togo has a population of 8.1 million (2019) and a gross domestic product (GDP) per capita of $679. Poverty had been declining prior to the pandemic. However, the pandemic — with  8,582 confirmed…
Date: April 13, 2021 Type: Result Brief

 

World Customs Organization – WCO [to 17 Apr 2021]
http://www.wcoomd.org/
Latest News – Selected Items
16 April 2021
Workshops held to raise awareness of counterfeit COVID-19-related goods
…This series of workshops, organized under the WCO’s Intellectual Property Rights (IPR), Health and Safety Programme, represents the Organization’s response to the challenge of ensuring the full preparedness of WCO Members for the safe and seamless distribution of time- and temperature-sensitive vaccines, as well as preventing organized criminal syndicates from exploiting the situation by flooding markets with dangerous, substandard or counterfeit vaccines.

15 April 2021
WCO Secretary General participates in WTO event on COVID-19 and Vaccine Equity

15 April 2021
Workshop organized by the COVID-19 Project supports the MENA region in facing disruptive events

 

World Organisation for Animal Health (OIE) [to 17 Apr 2021]
https://www.oie.int/en/for-the-media/press-releases/2021/
Press Releases
No new digest content identified.

 

WTO – World Trade Organisation [to 17 Apr 2021]
http://www.wto.org/english/news_e/news_e.htm
WTO News and Events
Chair Summary following “COVID-19 and Vaccine Equity: What Can the WTO Contribute?”
14 April 2021
Speech – DG Okonjo-Iweala provided this summary at the end of the event.
“…I believe that today’s exchanges have advanced our understanding of the challenges we face for scaling up vaccine production, and that working together is the only way ahead.

In the coming weeks and months, we expect concrete follow-up action. These issues are not easy, but the political will and engagement from the private sector displayed today, suggests it is possible.

 

 

As we move forward, I expect:
From WTO members:
:: Action to further reduce export restrictions and supply chain barriers, and to work with other organizations to facilitate logistics and customs procedures.  We are monitoring this as part of our regular work, and we’ll continue doing so to increase supplies and maintain robust supply chains. Trade has been underlined as a critical factor in production; it is incumbent upon WTO members to act.
:: Advance negotiations in the TRIPS Council on the waiver proposal and incentives for research and innovation. I hope that the ideas and the open dialogue heard will move us closer to agreement.

 

 

For vaccine manufacturers:
:: Concrete moves to scale up vaccine manufacturing, both short-term turnaround of existing capacities, milking whatever productivity gains we can from current facilities, and taking steps to invest.
:: Increased technology and knowhow transfer, which many participants stressed would be necessary to make additional production work.
:: We need transparency in contract agreements and product pricing. We hope to continue this dialogue and to help monitoring steps in that direction.

 

 

For international organisations and financial institutions:
:: We noted your willingness to finance, both existing and new capacity, your willingness to work on capacity building for regulatory issues, not just for vaccines, but also for therapeutics and diagnostics, which are equally important.

I trust that we have found a good basis to deliver concrete action, and to continue this discussion that we’ve had today…”

 

 

DG Okonjo-Iweala calls for follow-up action after WTO vaccine equity event
14 April 2021
Director-General Ngozi Okonjo-Iweala today (14 April) called on WTO members, vaccine manufacturers and international organizations to act to address trade-related obstacles to the scale-up of COVID-19 vaccine production to save lives, hasten the end of the pandemic and accelerate the global economic recovery.

DG Okonjo-Iweala: Equitable vaccine access key to sustained recovery for growth and trade
13 April 2021
In meetings in Washington, D.C. last week, Dr Ngozi Okonjo-Iweala, WTO Director-General, made the case that equitable worldwide access to COVID-19 vaccines is necessary for economic growth and trade to bounce back from the pandemic, and that a reinvigorated multilateral trading system would strengthen both the health response and the economic recovery.

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 17 Apr 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Press Releases
No new digest content identified.

 

BIO [to 17 Apr 2021]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 17 Apr 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 17 Apr 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 17 Apr 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA statement at WTO event “COVID-19 and Vaccine Equity: What can the WTO Contribute”
15 April 2021
On 14 April 2021, IFPMA and a number of its member company experts attended the WTO event “COVID-19 and Vaccine Equity: What can the WTO Contribute”.
The meeting was an opportunity to contribute to the WTO Director General, Ngozi Okonjo-Iweala, expressed desire to find pragmatic outcomes to increase COVID-19 vaccine production. IFPMA and its member companies used their interventions to share their experience of the complexities in researching, developing, registering, manufacturing and distributing COVID-19 vaccines.

Thomas Cueni, Director General, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) made the following intervention.
“When I look back a year, we from the innovative biopharmaceutical industry had the deep sense of responsibility. Because we knew that this was the biggest public health challenge the world has faced since the Spanish Flu.
We knew [then] that the world was expecting that the industry would find the keys to open the doors, to get us out of the tunnel.
I think it is quite amazing how far we have come in a year. In record time, in [just] 326 days (which is more than three years faster than the fastest ever developed vaccine in the past), we have not just one, but many safe and highly effective vaccines.
At the same time, when we look at the impatience from all of us to get the vaccines to everybody – we know that no one is safe until everyone is safe – I think we tend to forget the daunting task of scaling up manufacturing. Pre-COVID-19 global vaccine capacity was 5 billion doses a year. Here, we talk about manufacturing 10 billion doses for COVID-19 vaccines alone, in 2021.
And it is not surprising that we have seen bumps and hitches along the road. Vaccine manufacturing is a complex biological process. Vaccine development is not [guaranteed] success. We have seen problems with scarcity of raw materials ingredients, and we have heard this afternoon about problems of export restrictions.
We are on track with the target of 10 billion doses. And we are on track because industry is doing what society and all of you would have expected us to be doing. Namely, engaging in unprecedented partnerships and in unprecedented technology transfers. I have counted 272 partnerships, which the industry has signed on COVID-19. More than 200 of them involving technology transfer.
As we have heard from colleagues from the innovative industry but also from the Developing Countries Vaccine Manufacturers Network (DCVMN), this is not just about intellectual property.
:: It is about sharing know-how.
:: It is about building trust.
:: It is about joint training of skilled workers.
:: It is about providing access to trade secrets.
:: It is about building trust, that quality will be assured.
70% of vaccine manufacturing is about quality control and that is something which you cannot enforce. It is something, which to be honest, could even be jeopardized if you try to coerce it, because [technololgy transfer] is about two parties who build up trust with each other.
Now having said that:
:: we recently co-convened a roundtable with CEPI and Gavi, a roundtable to look at the challenges of [ahead].
:: we have seen many partners – Novartis, GSK, Sanofi, Novavax, Moderna working with others. I expect that we will see more. I expect that we will see more also in terms of partnership, building capacity
:: we are willing to sit down with our partners in COVAX to see what can be done in terms of supply chain visibility, in [reporting] export restrictions to accelerate trade – WTO will play an important role there.
We truly know that no one is safe until everyone is safe.”

 

PhRMA [to 17 Apr 2021]
http://www.phrma.org/
Selected Press Releases, Statements
PhRMA Statement on FDA Guidance on Remote Interactive Evaluations for Oversight of Drug Manufacturing Facilities During COVID-19
April 15, 2021
…“The U.S. Food and Drug Administration (FDA) guidance on remote interactive evaluations is an important step from the Agency in describing actions it may take to evaluate and oversee manufacturing facilities and enable timely regulatory decision-making. The biopharmaceutical industry recognizes that the COVID-19 pandemic has presented novel challenges to FDA in its regulatory oversight of manufacturing facilities. We applaud the FDA for adapting to these unique challenges and taking steps to describe the ‘remote interactive evaluations’ the Agency may conduct to facilitate regulatory decision-making and ensure timely access to new, innovative treatments for patients…

Diversifying clinical trials and fighting disease requires equity and trust
April 12, 2021
…recent polls highlight COVID-19 vaccine hesitancy within Black communities. In fact, only one in four Black Americans (24%) plan to get the vaccine compared to other racial and ethnic groups, and Black Americans are significantly trailing in vaccination rates.
Contributing to vaccine skepticism are the significant systemic health disparities that Black Americans have faced for many years – disparities that the pandemic further exposed. Historic wrongs, such as the abuses of the U.S. Public Health Service Syphilis Study at Tuskegee and absence of consent in the Henrietta Lacks’ story have seeded mistrust and had a lasting effect on the Black community.
Recent opinion research conducted by PhRMA[1] provides greater insight into some of the factors that contribute to mistrust and stand in the way of ensuring Black Americans have the information they need to make health decisions. One of the issues rising to the top of this research is a clear need for more diverse clinical trials, which is critical to accurately represent the intended patient population and achieving health equity. Currently, only one in 10 Black voters (13%) have participated in a clinical trial or know someone who has participated in a clinical trial for new medicines or treatments…

Journal Watch

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

Compassionate Force

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

 

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

Factors associated with parents’ experiences using a knowledge translation tool for vaccination pain management: a qualitative study

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 17 Apr 2021)

 

Factors associated with parents’ experiences using a knowledge translation tool for vaccination pain management: a qualitative study
Vaccination is a common painful procedure for children. Parents’ concern regarding vaccination pain is a significant driver of vaccine hesitancy. Despite the wealth of evidence-based practices available for ma…
Authors: Nicole E. MacKenzie, Perri R. Tutelman, Christine T. Chambers, Jennifer A. Parker, Noni E. MacDonald, C. Meghan McMurtry, Pierre Pluye, Vera Granikov, Anna Taddio, Melanie Barwick, Kathryn A. Birnie and Katelynn E. Boerner
Citation: BMC Health Services Research 2021 21:355
Content type: Research article
Published on: 16 April 2021

European data sources for computing burden of (potential) vaccine-preventable diseases in ageing adults

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 17 Apr 2021)

 

European data sources for computing burden of (potential) vaccine-preventable diseases in ageing adults
To guide decision-making on immunisation programmes for ageing adults in Europe, one of the aims of the Vaccines and InfecTious diseases in the Ageing popuLation (IMI2-VITAL) project is to assess the burden of…
Authors: Estelle Méroc, Janeri Fröberg, Timea Almasi, Brita Askeland Winje, Alejandro Orrico-Sánchez, Anneke Steens, Scott A. McDonald, Kaatje Bollaerts and Mirjam J. Knol
Citation: BMC Infectious Diseases 2021 21:345
Content type: Research article
Published on: 13 April 2021

Predictors of willingness to get a COVID-19 vaccine in the U.S

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 17 Apr 2021)

 

Predictors of willingness to get a COVID-19 vaccine in the U.S
As COVID-19 vaccine distribution efforts continue, public health workers can strategize about vaccine promotion in an effort to increase willingness among those who may be hesitant.
Authors: Bridget J. Kelly, Brian G. Southwell, Lauren A. McCormack, Carla M. Bann, Pia D. M. MacDonald, Alicia M. Frasier, Christine A. Bevc, Noel T. Brewer and Linda B. Squiers
Citation: BMC Infectious Diseases 2021 21:338
Content type: Research article
Published on: 12 April 2021

Trust and professionalism in science: medical codes as a model for scientific negligence?

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 17 Apr 2021)

 

Research article
Trust and professionalism in science: medical codes as a model for scientific negligence?
Professional communities such as the medical community are acutely concerned with negligence: the category of misconduct where a professional does not live up to the standards expected of a professional of sim…
Authors: Hugh Desmond and Kris Dierickx
Citation: BMC Medical Ethics 2021 22:45
Content type: Research article
Published on: 14 April 2021

Outbreak response operations during the US measles epidemic, 2017–19

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 17 Apr 2021)

 

Outbreak response operations during the US measles epidemic, 2017–19
To understand operational challenges involved with responding to US measles outbreaks in 2017–19 and identify applicable lessons in order to inform preparedness and response operations for future outbreaks, pa…
Authors: Elena K. Martin, Matthew P. Shearer, Marc Trotochaud and Jennifer B. Nuzzo
Citation: BMC Public Health 2021 21:620
Content type: Research article
Published on: 13 April 2021

Impact of early detection and vaccination strategy in COVID-19 eradication program in Jakarta, Indonesia

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 17 Apr 2021)

 

Impact of early detection and vaccination strategy in COVID-19 eradication program in Jakarta, Indonesia
Several essential factors have played a crucial role in the spreading mechanism of COVID-19 (Coronavirus disease 2019) in the human population. These factors include undetected cases, asymptomatic cases, and s…
Authors: Dipo Aldila, Brenda M. Samiadji, Gracia M. Simorangkir, Sarbaz H. A. Khosnaw and Muhammad Shahzad
Citation: BMC Research Notes 2021 14:132
Content type: Research note
Published on: 12 April 2021

The Complex Roadmap to Infectious Disease Innovation: The Intersection of Bugs, Drugs, and Special Populations

Clinical Pharmacology & Therapeutics
Volume 109, Issue 4 Pages: 783-1158 April 2021
https://ascpt.onlinelibrary.wiley.com/toc/15326535/current

 

Therapeutic Innovations in Infectious Diseases
Editorial
The Complex Roadmap to Infectious Disease Innovation: The Intersection of Bugs, Drugs, and Special Populations
Melanie R. Nicol, Emily J. Cicali, Shirley K. Seo, Gauri G. Rao

Real‐World Evidence for Assessing Pharmaceutical Treatments in the Context of COVID‐19

Clinical Pharmacology & Therapeutics
Volume 109, Issue 4 Pages: 783-1158 April 2021
https://ascpt.onlinelibrary.wiley.com/toc/15326535/current

 

Reviews State of the Art
Free Access
Real‐World Evidence for Assessing Pharmaceutical Treatments in the Context of COVID‐19
Jessica M. Franklin, Kueiyu Joshua Lin, Nicolle M. Gatto, Jeremy A. Rassen, Robert J. Glynn, Sebastian Schneeweiss
Pages: 816-828
First Published:02 February 2021

COVID-19 vaccine delivery: an opportunity to set up systems for the future

Gates Open Research
https://gatesopenresearch.org/browse/articles
[Accessed 17 Apr 2021]

 

Open Letter metrics
Revised
COVID-19 vaccine delivery: an opportunity to set up systems for the future [version 2; peer review: 2 approved with reservations]
Rebecca Weintraub, Stanley Plotkin, Margaret Liu, Jerome Kim, Natalie Garcon, David Bell, Dan Storisteanu, Toby Norman, Eliah Aronoff-Spencer
Peer Reviewers Kristin Nelson; Alan Gelb
Funder
Bill and Melinda Gates Foundation
LATEST VERSION PUBLISHED 14 Apr 2021
Abstract
The race to develop safe and effective SARS-COV-2 vaccines has moved with unprecedented speed. There are now multiple vaccines that have received emergency use authorization from the United States Food and Drug Administration and a host of candidates positioned for approval worldwide. Attention has now turned to allocation, distribution and verification of these vaccines, yet this focus exposes that the underlying infrastructure for global delivery and monitoring is threadbare and unevenly distributed. This presents both a barrier and an opportunity to deploy sustainable infrastructure. Major global stakeholders must convene quickly, collaborate, and collectively invest in global standards, legal models, common vocabularies and interoperable biometric-supported digital health technologies. As the COVID-19 vaccine effort scales, governments, private sector, and NGOs have the chance to place lasting resources needed for equitable and effective delivery that can pay dividends into the future.

Structural barriers to knowledge transfer and exchange among men and women in low-, middle- and high-income countries: an international cross-sectional study with vaccine researchers in 44 countries

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 17 Apr 2021]

 

Structural barriers to knowledge transfer and exchange among men and women in low-, middle- and high-income countries: an international cross-sectional study with vaccine researchers in 44 countries
Globally, women constitute 30% of researchers. Despite an increasing proportion of women in research, they are still less likely to have international collaborations. Literature on barriers to knowledge transfer and exchange (KTE) between men and women remains limited. This study aimed to assess perceived gender barriers to KTE activities in vaccination-related research in low-, middle- and high-income countries.
Authors: Soha El-Halabi, Ronan McCabe, Birger C. Forsberg, Devy L. Elling and Ziad El-Khatib
Content type: Research
12 April 2021

Disability inclusion in humanitarian action

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

 

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

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

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

Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19A Randomized Clinical Trial

JAMA
April 13, 2021, Vol 325, No. 14, Pages 1369-1480
https://jamanetwork.com/journals/jama/currentissue

 

Original Investigation
Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19A Randomized Clinical Trial
Eduardo López-Medina, MD, MSc; Pío López, MD; Isabel C. Hurtado, MD; et al.
free access has active quiz
JAMA. 2021;325(14):1426-1435. doi:10.1001/jama.2021.3071
This randomized trial compares the effects of ivermectin vs placebo on time to symptom resolution within 21 days among patients with mild COVID-19.

COVID-19 in 2021—Continuing Uncertainty

JAMA
April 13, 2021, Vol 325, No. 14, Pages 1369-1480
https://jamanetwork.com/journals/jama/currentissue

 

Viewpoint
COVID-19 in 2021—Continuing Uncertainty
Carlos del Rio, MD; Preeti Malani, MD, MSJ
free access has active quiz has multimedia has audio
JAMA. 2021;325(14):1389-1390. doi:10.1001/jama.2021.3760
This Viewpoint summarizes the current best evidence about COVID-19 vaccines, immunity, and whether SARS-CoV-2 will become an endemic or seasonal virus.
Conclusions
The world has transformed in the past year and some aspects of life may remain changed forever. COVID-19 may reoccur seasonally, like other respiratory viruses, most notably influenza. In addition, a substantial number of patients with post-COVID syndromes will experience various degrees of disabilities and symptoms for years. Infection risk aside, it will be essential for public health agencies and society to develop ways to safely continue essential activities, including in-person learning in the K-12 and higher education space. Social gatherings, sporting events, and other community activities will undoubtedly resume but some restrictions will continue depending on evidence of community spread, the proportion of individuals vaccinated, and other factors that will need to be monitored regularly as individuals, institutions, and governments all perform calculations to balance competing risks.

Blockchain, consent and prosent for medical research

Journal of Medical Ethics
April 2021 – Volume 47 – 4
http://jme.bmj.com/content/current

 

Original research
Blockchain, consent and prosent for medical research (4 May, 2020)
Sebastian Porsdam Mann, Julian Savulescu, Philippe Ravaud, Mehdi Benchoufi
Abstract
Recent advances in medical and information technologies, the availability of new types of medical data, the requirement of increasing numbers of study participants, as well as difficulties in recruitment and retention, all present serious problems for traditional models of specific and informed consent to medical research. However, these advances also enable novel ways to securely share and analyse data. This paper introduces one of these advances—blockchain technologies—and argues that they can be used to share medical data in a secure and auditable fashion. In addition, some aspects of consent and data collection, as well as data access management and analysis, can be automated using blockchain-based smart contracts. This paper demonstrates how blockchain technologies can be used to further all three of the bioethical principles underlying consent requirements: the autonomy of patients, by giving them much greater control over their data; beneficence, by greatly facilitating medical research efficiency and by reducing biases and opportunities for errors; and justice, by enabling patients with rare or under-researched conditions to pseudonymously aggregate their data for analysis. Finally, we coin and describe the novel concept of prosent, by which we mean the blockchain-enabled ability of all stakeholders in the research process to pseudonymously and proactively consent to data release or exchange under specific conditions, such as trial completion.

The ACT Accelerator: heading in the right direction?

The Lancet
Apr 17, 2021 Volume 397 Number 10283 p1419-1518
https://www.thelancet.com/journals/lancet/issue/current

 

Editorial
The ACT Accelerator: heading in the right direction?
The Lancet
April 24, 2021, marks 1 year since the formation of the Access to COVID-19 Tools Accelerator (ACT-A) partnership. Its mission is to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines, which is central to ending the acute phase of the COVID-19 pandemic. With the pandemic still raging, has ACT-A been successful so far? And what does the future hold?

ACT-A coordinates the strategy and work of several global health partners under four pillars: diagnostics, therapeutics, vaccines (COVAX), and health systems. Much of the attention has been focused on vaccines. COVAX plans to deliver 2 billion doses of COVID-19 vaccine by the end of the year, but its mission has been hamstrung by political realities and a lack of ambition.

The diagnostics pillar, led by the Foundation for Innovative New Diagnostics (FIND) and the Global Fund, aimed to develop new, affordable, high-quality tests, and to support the procurement and deployment of 500 million tests for low-income and middle-income countries (LMICs). In September, 2020, FIND announced that 120 million rapid diagnostic tests had been made available through ACT-A at a set price for LMICs. But large discrepancies exist in testing rates between high-income countries (620 tests per 100 000 people per day) versus low-income countries (6·5 tests per 100 000 people per day, with a high positivity rate of 13·3%). As with vaccines, individual rich countries can buy up tests directly from manufacturers. Countries with no resources to buy tests are left without. A lack of laboratory facilities for RT-PCR tests and the paucity of trained laboratory specialists leave many LMICs disadvantaged in reaching full testing capacity.

The therapeutics pillar, co-convened by Unitaid and the Wellcome Trust, is tasked with finding effective therapies and their large-scale, equitable distribution. Many potential treatments have unfortunately been found to be ineffective in clinical studies. The RECOVERY trial, co-funded by ACT-A partners, established dexamethasone as the first life-saving therapy for patients admitted to hospital with COVID-19, and ACT-A secured 2·9 million treatment courses for LMICs through advanced purchases. However, this figure is only a fraction of the pillar’s aim to deliver 245 million doses of therapeutics to LMICs. Strict patent and technology transfer regulations have hampered the scale-up of much needed vaccine manufacturing, and the same barriers will likely apply to new treatments such as monoclonal antibodies. ACT-A was also slow to take up the issue of medical oxygen, and other essential medicines for patients with COVID-19 remain in short supply.

The health systems pillar of ACT-A is narrow in scope, largely focused on the effective deployment of COVID-19 vaccines, treatments, and diagnostics and ensuring health-care workers in LMICs have sufficient personal protective equipment. These are unambitious goals. As David Hipgrave points out in a Correspondence, ACT-A neglects to ensure quality primary care and essential public health functions.

ACT-A was a necessary response to an emergency. It was quick to bring together partners and stimulate research and development of new technologies for COVID-19. But ACT-A is, in many ways, a traditional global health entity. Funding follows an international aid model, depending on the benevolence of rich donors. The result is a funding shortfall and a system not based on solidarity but rather one that reinforces inequities. This set-up must be rethought. Thomas Piketty, for example, has proposed a wealth tax of 2% to finance global public health goods. The partners of ACT-A are receiving huge amounts of public money in a global emergency. The minimum to expect in return is transparent and fair pricing, and the sharing of intellectual property, technology, and knowledge.

Furthermore, ACT-A is a vertical programme and heavily focused on technical solutions. Diagnostics, treatments, and vaccines are essential, but too little attention is given to health systems strengthening and systemic drivers of epidemics. The broader implications for ensuring social welfare and cohesion within countries and globally are profound. Any inequities will only prolong the pandemic.

On May 21, at the Global Health Summit in Rome, countries and organisations will discuss financing for the global COVID-19 response. ACT-A may be large in scale, but it suffers from the same shortcomings as countless previous global health initiatives. If ACT-A is to deliver on its goals, these weaknesses need to be confronted and overcome. Only then might it find a worthwhile place in the global health architecture, for this pandemic and beyond.

A genomic catalog of Earth’s microbiomes

Nature Biotechnology
Volume 39 Issue 4, April 2021
https://www.nature.com/nbt/volumes/39/issues/4

 

Resource | 09 November 2020 | Open Access
A genomic catalog of Earth’s microbiomes
Cataloging microbial genomes from Earth’s environments expands the known phylogenetic diversity of bacteria and archaea.
Stephen Nayfach, Simon Roux & Emiley A. Eloe-Fadrosh
Abstract
The reconstruction of bacterial and archaeal genomes from shotgun metagenomes has enabled insights into the ecology and evolution of environmental and host-associated microbiomes. Here we applied this approach to >10,000 metagenomes collected from diverse habitats covering all of Earth’s continents and oceans, including metagenomes from human and animal hosts, engineered environments, and natural and agricultural soils, to capture extant microbial, metabolic and functional potential. This comprehensive catalog includes 52,515 metagenome-assembled genomes representing 12,556 novel candidate species-level operational taxonomic units spanning 135 phyla. The catalog expands the known phylogenetic diversity of bacteria and archaea by 44% and is broadly available for streamlined comparative analyses, interactive exploration, metabolic modeling and bulk download. We demonstrate the utility of this collection for understanding secondary-metabolite biosynthetic potential and for resolving thousands of new host linkages to uncultivated viruses. This resource underscores the value of genome-centric approaches for revealing genomic properties of uncultivated microorganisms that affect ecosystem processes.

A comprehensive library of human transcription factors for cell fate engineering

Nature Biotechnology
Volume 39 Issue 4, April 2021
https://www.nature.com/nbt/volumes/39/issues/4

 

Resource | 30 November 2020
A comprehensive library of human transcription factors for cell fate engineering
A library of human transcription factor genes is screened for differentiation of human pluripotent stem cells.
Alex H. M. Ng, Parastoo Khoshakhlagh & George M. Church

The need for a new strategy for Ebola vaccination

Nature Medicine
Volume 27 Issue 4, April 2021
https://www.nature.com/nm/volumes/27/issues/4

 

Comment | 05 April 2021
The need for a new strategy for Ebola vaccination
News of two new outbreaks of Ebola virus disease in the Democratic Republic of the Congo and Republic of Guinea, on the backdrop of the COVID-19 pandemic, signals the need for a change of direction in vaccination strategies in the area.
Daniel G. Bausch

How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals

Nature Medicine
Volume 27 Issue 4, April 2021
https://www.nature.com/nm/volumes/27/issues/4

 

Comment | 05 April 2021
How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals
A comprehensive overview of medical AI devices approved by the US Food and Drug Administration sheds new light on limitations of the evaluation process that can mask vulnerabilities of devices when they are deployed on patients.
Eric Wu, Kevin Wu & James Zou