Vaccines and Global Health: The Week in Review :: 28 March 2020

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WHO: Guiding principles for immunization activities during the COVID-19 pandemic Interim guidance – 26 March 2020

Milestones :: Perspectives :: Research

 

WHO: Guiding principles for immunization activities during the COVID-19 pandemic
Interim guidance – 26 March 2020
**As the COVID-19 pandemic evolves, this document and accompanying FAQ will be revised as necessary. **

Due to the global circulation of the virus causing COVID-19 and the current pandemic, there is risk of disruption to routine immunization activities due to both COVID-19 related burden on the health system and decreased demand for vaccination because of physical distancing requirements or community reluctance. Disruption of immunization services, even for brief periods, will result in increased numbers of susceptible individuals and raise the likelihood of outbreak-prone vaccine preventable diseases (VPDs) such as measles.1 Such VPD outbreaks may result in increased morbidity and mortality predominantly in young infants and other vulnerable groups, which can cause greater burden on health systems already strained by the COVID-19 response. The high potential for VPD outbreaks makes it imperative for countries to maintain continuity of immunization services wherever services can be conducted under safe conditions. Prior disease outbreaks and humanitarian emergencies have underscored the importance of maintaining essential health services such as immunization, and effectively engaging communities in planning and service delivery. 2,3 Yet the complexity and global reach of the COVID-19 response with respect to mandatory physical distancing (also referred to as social distancing) and economic impact on households is unprecedented for public
health.

This document provides guiding principles and considerations to support countries in their decision-making regarding provision of immunization services during the COVID-19 pandemic and is endorsed by the WHO’s Strategic Advisory Group of Experts on Immunization. It is complemented by a range of WHO technical materials on response and mitigation measures for COVID-19.4 Each country will need to make individual risk assessments based on the local dynamics of COVID-19 transmission, immunization and health system characteristics, and current VPD epidemiology in their setting.

 

Guiding Principles
1. Immunization is a core health service that should be prioritized for the prevention of communicable diseases and safeguarded for continuity during the COVID-19 pandemic, where feasible.5 Immunization delivery strategies may need to be adapted and should be conducted under safe conditions, without undue harm to health workers, caregivers and the community.6

2. VPD surveillance should be maintained and reinforced to enable early detection and management of VPD cases, and where feasible, contribute to surveillance of COVID-19.

3. National authorities will need to continuously monitor the dynamics of COVID-19 in their country or region. National Immunization Technical Advisory Groups (NITAGs) have an important role in providing advice with respect to the maintenance, adaptation, suspension and/or reinstatement of immunization services.

4. If provision of immunization services is negatively impacted by COVID-19, countries will need to design strategies for catch-up vaccination for the period post COVID-19 outbreak and make plans which anticipate a gradual recovery. Implementation of catch-up will require strategies to track and follow-up with individuals who missed vaccinations, assess immunity gaps, and re-establish community demand. Innovation and creativity will be required.

 

5. Based on the current understanding of transmission of the COVID-19 virus and recommendations for physical distancing, mass vaccination campaigns should be temporarily suspended. Countries should monitor and re-evaluate at regular intervals the necessity for delaying mass vaccination campaigns.

6. The conduct of outbreak response mass vaccination campaigns will require a careful risk-benefit analysis on a case-by-case basis, assessing risks of a delayed response against the risks associated with an immediate response, both in terms of morbidity and mortality for the VPD and the potential impact of further transmission of the COVID-19 virus.

7. Where feasible, influenza vaccination of health workers, older adults, and pregnant women is advised.7

 

Considerations for Routine Immunization and VPD Surveillance
:: The decision to maintain immunization services will be influenced by local mandates for physical distancing and guided by health system context, the local burden of VPDs, the status and anticipated status of local COVID-19 transmission (classified as no cases, sporadic, clusters, or community transmission), and factors such as population demographics and migration patterns.

:: Where health system capacity is intact and essential health services are operational (e.g., adequate human resources, adequate vaccine supply), fixed site immunization services and VPD surveillance should be executed while maintaining physical distancing measures and appropriate infection control precautions, equipped with the necessary supplies for those precautions.8

:: The appropriateness of implementing alternative strategies (e.g. outreach or mobile services), as well as activities requiring community interaction for VPD surveillance, must be assessed in the local context and should be adapted to ensure the safety of the health workers and community. Innovative methods for vaccination delivery should be explored to optimize service delivery.

:: Where the provision of limited services is feasible, immunization of vulnerable populations at increased risk of morbidity and mortality due to VPDs should be prioritized for vaccination against outbreak-prone diseases such as measles, polio, diphtheria and yellow fever.

 

Considerations for Mass Vaccination Campaigns
:: Based on the current understanding of the transmission modes of the COVID-19 virus and the recommended prevention measures of physical distancing, it is advised to temporarily suspend the conduct of mass vaccination campaigns due to the increased risk of promoting community circulation. Countries should monitor and re-evaluate at regular intervals the necessity for the delay of mass vaccination campaigns.

:: Under circumstances of a VPD outbreak, the decision to conduct outbreak response mass vaccination campaigns will require a risk-benefit assessment on a case by case basis and must factor in the health system’s capacity to effectively conduct a safe and high-quality mass campaign in the context of the COVID-19 pandemic. The assessment should evaluate the risks of a delayed response against the risks associated with an immediate response, both in terms of morbidity and mortality for the VPD and the potential impact of further transmission of the COVID-19 virus.

 

:: Should an outbreak response vaccination campaign be pursued, stringent measures are required to uphold standard and COVID-19 infection prevention and control, adequately handle injection waste, protect health workers and safeguard the public.

:: Should an outbreak response vaccination campaign be delayed, a periodic assessment based on local VPD morbidity and mortality, as well as regional and international epidemiology will be required to evaluate risk of further delay.

 

Consideration for Re-establishing Immunization Services
:: In circumstances where immunization services must be diminished or suspended, countries should reinstate and reinvigorate immunization services at the earliest opportunity to close immunity gaps, once reduced local transmission of the COVID-19 virus permits primary health care services to resume.

:: If resources for catch-up are limited, catch-up immunization activities should place priority on outbreak-prone VPDs such as measles, polio, diphtheria, and yellow fever.

:: Countries should implement effective communication strategies and engage with communities to allay concerns, enhance community linkages and re-establish community demand for vaccination.

1 Suk et al. Post-Ebola Measles Outbreak in Lola,Guinea, January–June 2015. Emerging Infectious Diseases. 2016; 22(6):1106-1108.
2 http://www.jogh.org/documents/issue201802/jogh-08-020601.htm
3 Vaccination in Acute Humanitarian Emergencies: A Framework for decision-making
https://www.who.int/immunization/documents/who_ivb_17.03/en/
4 https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance
5 COVID-19: Strategic Planning and Operational Guidance for Maintaining Essential Health Services During an Outbreak. 20 March 2020.
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance
6 https://www.who.int/publications-detail/infection-prevention-and-control-during-health-care-when-novel-coronavirus-(ncov)-infection-is-suspected-20200125
7 WER, 23 November 2012, 23 No. 47, 2012, 87, 461–476 https://www.who.int/wer/2012/wer8747.pdf?ua=1
8 https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/infection-prevention-and-control

© World Health Organization 2020. Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO licence.
WHO reference number: WHO/2019-nCoV/immunization_services/2020.1

 

Related documents
:: Guidance for health-care workers during COVID-19
:: COVID-19: Operational guidance for maintaining essential health services during an outbreak

 

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Polio Eradication in the context of the COVID-19 pandemic
Summary of urgent country and regional recommendations from the Polio Oversight Board meeting of March 24, 2020
The COVID-19 pandemic response requires worldwide solidarity and an urgent global effort. The Global Polio Eradication Initiative (GPEI), with thousands of polio workers, and an extensive laboratory and surveillance network, is positioned and ready to ensure that our resources are used by countries in their preparedness and response. The COVID-19 emergency means that many aspects of the polio eradication programme will be—and in some areas are already– substantially affected.

In light of these considerations, the Polio Oversight Board (POB) of GPEI recommends:
1. All polio eradication country programmes prioritize support for the response to COVID-19. Specifically, for the next 4-6 months, GPEI assets (technical expertise, surveillance and community networks, and logistics capacity) at all levels (global, regional, national, and local levels) should be made available to support the global response to COVID-19. GPEI staff supporting COVID-19 front line activities, must be provided with the necessary training, materials, equipment and logistics to do so safely. Additionally, if required, GPEI financial management systems could be used to support the channelling of COVID-19 funding for the pandemic response.

2. Critical functions related to Polio Acute Flaccid Paralysis and Environmental Surveillance should remain a priority and governments should do all they can to ensure they continue, to closely monitor the circulation of wild and vaccine-derived polioviruses. As much as possible, these surveillance activities should be paired with COVID-19 surveillance and data systems upgraded to support this expanded portfolio of work. To facilitate this work, the provision of personal protective equipment for surveillance officers should be prioritized.

3. All polio activities which come in contradiction to global guidance on physical distancing, such as house-to-house or other immunization activities using oral or injectable vaccines1, should be suspended to avoid placing communities and frontline workers at unnecessary risk, and facilitate rapid and effective COVID-19 response in countries. Specifically,
a. All preventive polio campaigns should be postponed until the second half of 2020.

b. Endemic countries, and non-endemic countries planning to conduct outbreak responses campaigns, should postpone all campaigns (mOPV2, bOPV) until June 1, 2020 and then reevaluate based on the status of the COVID-19 pandemic. Any country wishing to proceed with polio vaccination campaigns should only implement such campaigns after a thorough assessment of risk of COVID-19 transmission among frontline workers and communities and potential impact on immunization programs. Vaccines currently approved for preventative SIAs and outbreak response will be shipped, unless a country has decided to postpone that campaign. New vaccine requests will be considered on a case-by-case basis.

4. Efforts to obtain an Emergency Use Listing recommendation for novel Oral Polio Vaccine type 2 (nOPV2), must continue at full speed. The preparation for nOPV2 roll-out, across the range of technical, communications, policy and manufacturing activities should also continue. Engagement with countries around initial use of nOPV2 will continue, as appropriate to their specific COVID-19 situation, with the goal of deploying nOPV2 for outbreak response during the second half of 2020.

5. While halting important polio eradication activities is necessary, it will result in increased spread of disease and number of children paralyzed by wild and circulating vaccine-derived polioviruses. This will require a scale up of polio eradication efforts once the COVID-19 situation has stabilized. Without compromising support to the COVID-19 response, country programmes should take the opportunity during the pause in vaccination campaigns to improve other elements of the program such as strategic planning and performance management processes. Finally, GPEI and country programmes must develop a comprehensive set of context-specific strategies and a plan for resumption of operations.
This guidance and the timelines will be reviewed by the Strategy Committee on a bi-weekly schedule given the rapidly changing situation with COVID-19.

1 Guiding principles for immunization activities during the COVID-19 pandemic, endorsed by SAGE, can be found here: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/maintaining-essential-health-services-and-systems

 

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Statement
Statement by UNICEF Executive Director Henrietta Fore on the disruption of immunization and basic health services due to the COVID-19 pandemic
NEW YORK, 26 March 2020: “Around the world, the COVID-19 pandemic is overstretching health services as health workers are diverted to support the response.

“Physical distancing is leading parents to make the difficult decision to defer routine immunization.

“Medical goods are in short supply and supply chains are under historic strain due to transport disruptions. Flight cancellations and trade restrictions by countries have severely constrained access to essential medicines, including vaccines.

“As the pandemic progresses, critical life-saving services, including immunization, will likely be disrupted, especially in Africa, Asia and the Middle East where they are sorely needed.
“At the greatest risk are children from the poorest families in countries affected by conflicts and natural disasters.

“We are particularly concerned about countries that are battling measles, cholera or polio outbreaks while responding to COVID-19 cases, such as Afghanistan, the Democratic Republic of Congo, Somalia, the Philippines, Syria and South Sudan. Not only would such outbreaks tax already stretched health services, they could also lead to additional loss of lives and suffering. At a time like this, these countries can ill-afford to face additional outbreaks of vaccine-preventable diseases.

“The message is clear: We must not allow lifesaving health interventions to fall victim to our efforts to address COVID-19.

“UNICEF is committed to supporting basic health care and immunization needs in the worst affected countries, and to doing so in a way that limits the risk of COVID-19 transmission. We are working hard to ensure adequate vaccine supplies are available in countries that need them. We are in close communication with global vaccine suppliers to ensure production is not disrupted and supply is managed in the best possible manner under these difficult circumstances. We are also providing greater support to governments to continue the supply of vaccines during this pandemic.

“In the days to come, governments may have to temporarily postpone preventive mass vaccination campaigns in many places to ensure that the delivery of immunization services does not contribute to COVID-19 spread, and to follow recommendations on physical distancing.
“UNICEF strongly recommends that all governments begin rigorous planning now to intensify immunization activities once the COVID -19 pandemic is under control. These vaccination activities must focus on children who will miss vaccine doses during this period of interruption and prioritize the poorest and most vulnerable children. To successfully roll-out vaccines against COVID -19 when they become available, we need to ensure that our immunization programmes remain robust and can reach those that will need these vaccines the most.

“Immunization remains a life-saving health intervention. As the world’s biggest buyer and supplier of vaccines, UNICEF will continue to play a pivotal role in supporting governments’ current and future immunization efforts.”

COVID-19 needs a Manhattan Project

Milestones :: Perspectives :: Research

 

Science
27 March 2020 Vol 367, Issue 6485
http://www.sciencemag.org/current.dtl
Editorial
COVID-19 needs a Manhattan Project
By Seth Berkley
There is an unprecedented race to develop a vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). With at least 44 vaccines in early-stage development, what outcome can we expect? Will the first vaccine to cross the finish line be the safest and most effective? Or will it be the most well-funded vaccines that first become available, or perhaps those using vaccine technologies with the fewest regulatory hurdles? The answer could be a vaccine that ticks all these boxes. If we want to maximize the chances for success, however, and have enough doses to end the coronavirus disease 2019 (COVID-19) pandemic, current piecemeal efforts won’t be enough. If ever there was a case for a coordinated global vaccine development effort using a “big science” approach, it is now.

There is a strong track record for publicly funded, large-scale scientific endeavors that bring together global expertise and resources toward a common goal. The Manhattan Project brought about nuclear weapons quickly (although with terrible implications for humanity) through an approach that led to countless changes in how scientists from many countries work together. The Human Genome Project and CERN (the European Organization for Nuclear Research) engaged scientists from around the world to drive basic research from their home labs through local and virtual teamwork. Taking this big, coordinated approach to developing a SARS-CoV-2 vaccine will not only potentially save hundreds of thousands of lives, but will also help the world be better prepared for the next pandemic.

An initiative of this scale won’t be easy. Extraordinary sharing of information and resources will be critical, including data on the virus, the various vaccine candidates, vaccine adjuvants, cell lines, and manufacturing advances. Allowing different efforts to follow their own leads during the early stages will take advantage of healthy competition that is vital to the scientific endeavor. We must then decide which vaccine candidates warrant further exploration purely on the basis of scientific merit. This will require drawing on work already supported by many government agencies, independent organizations like the Coalition for Epidemic Preparedness Innovations, and pharmaceutical and biotech companies to ensure that no potentially important candidate vaccines are missed. Only then can we start to narrow in on those candidates to be advanced through all clinical trial phases. This shortlist also needs to be based on which candidates can be developed, approved, and manufactured most efficiently.

Trials need to be carried out in parallel, not sequentially, using adaptive trial designs, optimized for speed and tested in different populations—rich and developing countries, from children to the elderly—so that we can ultimately protect everyone. Because the virus is spreading quickly, testing will be needed in communities where we can get answers fast—that means running trials anywhere in the world, not just in preset testing locations. Working with regulators early in the process will increase the likelihood of rapid approvals, and then once approved, a coordinated effort will ensure that sufficient quantities are available to all who need the vaccine, not just to the highest bidder.

All of this will require substantial funding, which is the big ask of big science. Late-stage clinical trials are not cheap, nor is vaccine manufacturing. Although new modular manufacturing methods may speed up the process and cut costs, a single vaccine facility can cost half a billion dollars. Distribution comes at a cost, too. So, to guarantee sufficient production of SARS-CoV-2 vaccines, incentives are needed to engage manufacturers for large-scale capacity. As for dissemination, those organizations with experience in global vaccine distribution, like Gavi, will be at the ready.

Ideally, this effort would be led by a team with a scientific advisory mechanism of the highest quality that could operate under the auspices of the World Health Organization (WHO), for example. But none of this will be possible without political will and a global commitment from leaders of the G7 and G20 countries and multilateral organizations, like the WHO and the World Bank. A pandemic of this magnitude, affecting so many lives, livelihoods, and economies, demands this.

In many ways, COVID-19 is more like the Manhattan Project than other big science efforts, not just because it involves the application of science and not just in terms of scale, but because it is a global security issue. In the race to develop a SARS-CoV-2 vaccine, everyone must win.

IFPMA Backgrounder – COVID-19

Milestones :: Perspectives :: Research

 

IFPMA Backgrounder – COVID-19
27 March 2020
[Excerpts]
…Vaccine development
While vaccines and small molecule treatments are approved through different regulatory pathways and their development programs vary, they generally both must complete three phases of clinical trials. However, there are differences in the data required to show the safety of vaccines and the size of clinical trials for vaccines relative to small molecules.
Experts are hoping it will take as little as 12 to 18 months before there is a vaccine available. This is a best-case estimate that assumes one or two of the first few vaccines that enter development will be successful. Typically, only approximately one in ten experimental vaccines make it all the way through to regulatory approval. Therefore, the more companies taking different approaches to find a vaccine, the more “shots on goal” and significantly greater chances of success.
:: CEPI and GSK will collaborate to help the global effort to develop a vaccine for the novel
:: CSL Limited/ Seqirus is providing scientific and technical expertise and its established MF59® adjuvant technology to the University of Queensland in Australia to help fast-track the development of their CEPI-funded COVID-19 vaccine candidate, which uses novel molecular-clamp technology.
:: GSK announced it would partner with the Chinese biotech company Clover Biopharmaceuticals. Under the partnership, GSK will provide Clover with its proprietary adjuvants – compounds that enhance the effectiveness of vaccines. By mid-March, GSK expanded their collaborations and is now working with five partner companies and research groups across the world, including in the USA and China.
:: Johnson & Johnson expanded its collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of U.S. Department of Health & Human Services (HHS), and established a new collaboration with Beth Israel Deaconess Medical Center (BIDMC), to accelerate development of a potential novel coronavirus vaccine.
:: Pfizer and BioNTech have entered into a partnership to jointly develop BioNTech’s mRNA-based vaccine candidate BNT162 to prevent COVID-19 infection. The collaboration aims to accelerate global development of BNT162, which is expected to enter clinical testing by the end of April 2020.
:: Sanofi announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), to advance a novel COVID-19 vaccine candidate. Work is underway to leverage previous development of a SARS vaccine candidate using Sanofi’s recombinant DNA technology. Sanofi is also coordinating with the Coalition for Epidemic Preparedness Innovations (CEPI) and sharing its vaccine R&D experience and expertise to advance vaccine solutions.
:: Sanofi and U.S. company Translate Bio announced plans to collaborate on developing a vaccine to treat the coronavirus. The companies said Translate Bio would work on discovering, designing, and manufacturing a number of SARS-CoV-2 vaccine candidates, while Sanofi would provide its expertise in the field of vaccines and support from its research networks…

 

Treatment development
As of March 2020, there are at least: 14 companies with a medicine in early phase research, 4 companies with a medicine in Phase I of development and 3 in Phase II, and one company has a medicine in Phase III trials. Listed below is a snapshot of the different areas of research focused on finding a new treatment”
:: AbbVie announced it is partnering with global authorities to determine the effectiveness of HIV drugs in treating COVID-19. AbbVie is supporting clinical studies and basic research with lopinavir/ritonavir, working closely with European health authorities and the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention, National Institutes of Health and the Biomedical Advanced Research and Development Authority to coordinate these efforts.
:: AstraZeneca’s Research and Development (R&D) teams have also been working expeditiously to identify monoclonal antibodies to progress towards clinical trial evaluation as a treatment to prevent COVID-19. More than 50 virology, immunology, respiratory, and protein engineering experts across research, clinical, regulatory, and manufacturing are placing the highest priority on developing a treatment to minimise the global impact of the disease.
:: Eli Lilly and AbCellera (Canadian biotech firm) have entered into an agreement to co-develop antibody products for the treatment and prevention of COVID-19. The collaboration will leverage AbCellera’s rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform (P3) Program, and Lilly’s global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies.
:: EFPIA is working with the Innovative Medicines Initiative (IMI) on potential actions to support collaborative research programs in order to fast-track the development of therapeutics.
:: Gilead has initiated two Phase 3 clinical trials of remdesivir in countries with high prevalence of COVID-19. The company is also supporting two Phase 3 trials in China and a global Phase 2 trial led by the U.S. National Institute of Allergy and Infectious Diseases. Gilead donated drug and provided scientific input for these studies. Gilead has provided remdesivir to physicians for compassionate use to treat several hundred severely ill patients with confirmed COVID-19, and has accelerated manufacturing of remdesivir at risk, in anticipation of potential future supply needs.
:: GSK is entering into the new collaborative research effort, the COVID-19 Therapeutics Accelerator. The aim of the Accelerator is to bring pharmaceutical companies and expert academic institutions into coordinated research programs, with the aim of bringing the most promising molecules forward that could be used to treat cases of COVID-19. GSK will contribute by making available compounds from its libraries for screening for activity against COVID-19. In addition, GSK is evaluating its marketed pharmaceutical products and medicines in development to determine if any could be used beyond their current indications in response to the pandemic. Further, GSK is evaluating options to make available specialised laboratory space to help in research and testing of COVID-19.
:: Johnson & Johnson, in partnership with the Rega Institute for Medical Research, University of Leuven (Belgium), are working to identify existing or new compounds with antiviral activity against COVID-19 that could contribute to providing immediate relief to the current outbreak.
:: Merck, as part of the global effort to investigate potential therapeutics for COVID-19 and their support of independent research, recently donated a supply of interferon beta-1a (Rebif®) to the French Institut National de la Santé et de la Recherche Médicale (INSERM) following a request for use in a clinical trial. To date, Merck’s interferon beta-1a is not approved by any regulatory authority for the treatment of COVID-19 or for use as an antiviral agent.
:: Novartis announced that it has entered new collaborative research efforts such as the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard, as well as a COVID-19 directed partnership organized by the Innovative Medicines Initiative. Novartis is contributing by making available several compounds from its libraries that are considered suitable for in vitro antiviral testing. In addition, the company is rapidly evaluating other existing products to see if any could be utilized beyond their approved indications in response to the pandemic.
:: Pfizer announced that it completed a preliminary assessment of certain antiviral compounds that were previously in development and that inhibited the replication of coronaviruses similar to the one causing COVID-19 in cultured cells. Pfizer is engaging with a third party to screen these compounds under an accelerated timeline and expects to have the results back by the end of March.
:: Pfizer also outlined a detailed 5-point action plan to battle COVID-19. The plan includes a commitment to sharing its clinical development and regulatory expertise to support other smaller biotech companies that are screening compounds or existing therapies for activity against the virus causing COVID-19.
:: Regeneron Pharmaceuticals announced an expanded agreement with the U.S. Department of Health and Human Services (HHS) to develop new treatments combating the novel coronavirus.
:: Regeneron Pharmaceuticals and Sanofi SA started a clinical program evaluating Kevzara, originally a drug to treat arthritis, in patients hospitalized with severe COVID-19. Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19 infection.
:: Roche’s Actemra was approved by China on March 5 to treat Covid-19 patients with lung complications. Roche has donated nearly $2m-worth of Actemra to China to help the country manage the COVID-19 outbreak”. Actemra has been on the European market since 2010 for treatment of several kinds of arthritis.
:: Roche announced that they are working with the Food & Drug Administration (FDA) to initiate a Phase III clinical trial to evaluate the safety and efficacy of Actemra in hospitalised adult patients with severe COVID-19 pneumonia. This is the first global study of Actemra in this setting and is expected to begin enrolling as soon as possible in early April with a target of approximately 330 patients globally, including the US.
:: Takeda announced that it is initiating the development of a drug to treat people infected with the novel coronavirus. The experimental drug would be derived from the blood of coronavirus patients who have recovered from the respiratory disease. In parallel, Takeda is also exploring whether currently marketed and pipeline products may be an effective treatment option for infected patients…

Life Sciences Companies Commit Expertise and Assets to the Fight Against COVID-19 Pandemic Alongside Bill & Melinda Gates Foundation

Milestones :: Perspectives :: Research

 

Life Sciences Companies Commit Expertise and Assets to the Fight Against COVID-19 Pandemic Alongside Bill & Melinda Gates Foundation
Collaboration to address product development and scale-up challenges posed by the current pandemic
SEATTLE, March 25, 2020 – Today, a consortium of life sciences companies announced an important collaboration to accelerate the development, manufacture, and delivery of vaccines, diagnostics, and treatments for COVID-19. The life sciences industry brings a range of assets, resources, and expertise needed to identify effective and scalable solutions to the pandemic, which is affecting billions worldwide. The impact on health systems, economies, and livelihoods is profound, and an effective response requires an unprecedented collaboration across governments, academia, the private sector, and the philanthropic community.

As co-chair of a consortium life science companies headquartered across three continents, Vas Narasimhan, chief executive officer of Novartis, said, “We feel a deep shared responsibility to see if there are specific areas where collaboration across the life sciences industry and the Bill & Melinda Gates Foundation can accelerate solutions to this pandemic. In addition to the individual contributions companies are already making, collective action is critical to ensure any promising studies into vaccines, drugs, and diagnostics are quickly scaled to people around the world who are affected by this pandemic.”

Trials of existing drugs, diagnostic tests, compounds, and investigational vaccines have begun across the globe to identify interventions that could slow or end the pandemic. Products that demonstrate efficacy will require clinical study, scale up of manufacturing, and distribution if proven effective. The life sciences industry has extensive experience in managing these processes for products that reach billions of people every day.

“We know that the private sector is where the technical skills and know-how regarding discovery, clinical trials, and commercialization sit,” said Mark Suzman, chief executive officer of the Bill & Melinda Gates Foundation. “We look to harness that knowledge and experience—combining it where possible—to connect with national regulators and the World Health Organization to see if we can help flatten the curve of this epidemic and make sure the results reach everyone around the world, particularly those at highest risk and the poorest.”

Following a conference call with Gates Foundation leadership earlier this month, companies are working to identify concrete actions that will accelerate treatments, vaccines, and diagnostics to the field. As a first step, 15 companies have agreed to share their proprietary libraries of molecular compounds that already have some degree of safety and activity data with the COVID-19 Therapeutics Accelerator—launched by the Gates Foundation, Wellcome, and Mastercard two weeks ago—to quickly screen them for potential use against COVID-19. Successful hits would move rapidly into in vivo trials in as little as two months.

“This is an encouraging start in a critical area, because if any of these compounds are shown to be effective against COVID-19, it dramatically accelerates the path to product approval and scale up,” said Suzman. “While each of the consortium’s partners will also be pursuing independent efforts with national governments and others, we are optimistic that this unprecedented collaboration will provide a platform for a fundamentally different kind of partnership to help address this global health emergency.”

Companies participating in the collaboration include BD, bioMérieux, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck (known as MSD outside the U.S. and Canada), Merck KGaA, Novartis, Pfizer, and Sanofi.

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

EMERGENCIES

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

Editor’s Note:
We certainly recognize the velocity of global developments in the COVID-19 pandemic. While we have concentrated the most current key reports just below, COVID-19 announcements, analysis and commentary will be found throughout this issue, in all sections.
Beyond the considerable continuing coverage in the global general media:
:: Daily WHO situation reports here: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports
:: WHO Coronavirus disease (COVID-2019) daily press briefings here: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/media-resources/press-briefings

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Situation report – 67 [WHO]

Novel Coronavirus (COVID-19)
27 March 2020
[Excerpts]
SITUATION IN NUMBERS
Globally
509 164 confirmed (46 484)
23 335 deaths (2501)

Western Pacific Region
100 018 confirmed (960)
3567 deaths (27)

European Region
286 697 confirmed (36 414)
16 105 deaths (2155)

South-East Asia Region
2932 confirmed (396)
105 deaths (26)

Eastern Mediterranean Region
35 249 confirmed (2807)
2336 deaths (174)

Region of the Americas
81 137 confirmed (5425)
1176 deaths (111)

African Region
2419 confirmed (482)
39 deaths (8)

WHO RISK ASSESSMENT
Global Level – Very High

HIGHLIGHTS
:: Two new countries/territories/areas from the Region of the Americas [2] have reported cases of COVID-19.

:: The total global number of COVID-19 cases has surpassed 500 000.

:: Addressing the Extraordinary Summit on COVID-19, the WHO Director-General called on G20 leaders to fight, unite, and ignite against COVID-19.

:: WHO concluded the technical support mission to Egypt on 25 March 2020. More information can be found on the Eastern Mediterranean Regional Office site.

:: OpenWHO celebrates 1 million enrollments today. Seventy percent of the total enrollments are on COVID-19 resources, reflecting the critical role the platform is playing in supporting the response to the pandemic. On 25 March, a new course was launched describing how to design and operate treatment centres for the COVID-19 pandemic. COVID-19 resources are hosted on two learning channels: one for courses in official WHO languages and a second for courses in additional national languages.

:: The number of countries implementing additional health measures that significantly interfere with international traffic has increased since the declaration of COVID-19 as a public health emergency of international concern. The United Nations World Tourism Organization launched a Crisis Committee to review the impact of the outbreak on the aviation, shipping and tourism sectors and propose innovative solutions for recovery.

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

Emergencies

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

Ebola Outbreak in DRC 85: 24 March 2020
[Excerpts]
Situation Update
No new cases of Ebola virus disease (EVD) have been reported since 17 February 2020. The last person confirmed to have Ebola was discharged from an Ebola Treatment Centre on 3 March 2020 after recovering and testing negative for the virus twice. The last 46 contacts finished their follow-up period on 9 March 2020. These developments are significant milestones in this outbreak. There is, however, still a high risk of re-emergence of EVD, and it is critical to maintain response activities to rapidly detect and respond to any new cases, and to continue ongoing support and health monitoring operations for EVD survivors – as outlined in the WHO recommended criteria for declaring the end of the EVD outbreak.
Extensive surveillance, pathogen detection, and clinical management activities in previously affected areas continue, including alert validation, rapid diagnosis of suspected cases, and building of partnerships with community members to strengthen investigation of potential community EVD deaths…

…Conclusion
Given the challenges related to continued insecurity and population displacement in previous hotspots, limited access to some affected communities, and potential shortages of resources required to carry out response activities, there remains a high risk of re-emergence of the virus in the period leading up to the declaration of the end of the outbreak, as well as for several months following that declaration. In order to mitigate the risk of re-emergence, it is essential to maintain surveillance and rapid response capacities, prioritize survivor care, and maintain cooperative relationships with survivors’ associations.

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