Vaccines and Global Health: The Week in Review :: 25 April 2020

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

Global leaders unite to ensure everyone everywhere can access new vaccines, tests and treatments for COVID-19 :: Commitment and call to action: Global collaboration to accelerate new COVID-19 health technologies :: Why the world needs $8 billion now to get us to COVID-Zero

Milestones :: Perspectives :: Research

 

COVID-19 :: Global Strategy/Commitments

Global leaders unite to ensure everyone everywhere can access new vaccines, tests and treatments for COVID-19
Unprecedented gathering of heads of government, institutions and industry cements commitment to accelerate development and delivery for all populations
24 April 2020 News release
GENEVA – Heads of state and global health leaders today made an unprecedented commitment to work together to accelerate the development and production of new vaccines, tests and treatments for COVID-19 and assure equitable access worldwide.

The COVID-19 pandemic has already affected more than 2.4 million people, killing over 160,000. It is taking a huge toll on families, societies, health systems and economies around the world, and for as long as this virus threatens any country, the entire world is at risk.

There is an urgent need, therefore, while following existing measures to keep people physically distanced and to test and track all contacts of people who test positive, for innovative COVID-19 vaccines, diagnostics and treatments.

“We will only halt COVID-19 through solidarity,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Countries, health partners, manufacturers, and the private sector must act together and ensure that the fruits of science and research can benefit everybody.”

Work has already started. Since January, WHO has been working with researchers from hundreds of institutions to develop and test vaccines, standardize assays and standardize regulatory approaches on innovative trial designs and define criteria to prioritize vaccine candidates.  The Organization has prequalified diagnostics that are being used all over the world, and more are in the pipeline. And it is coordinating a global trial to assess the safety and efficacy of four therapeutics against COVID-19.

The challenge is to speed up and harmonize processes to ensure that once products are deemed safe and effective, they can be brought to the billions of people in the world who need them. Past experience, in the early days of HIV treatment, for example, and in the deployment of vaccines against the H1N1 outbreak in 2009, shows that even when tools are available, they have not been equally available to all.

So today leaders came together at a virtual event, co-hosted by the World Health Organization, the President of France, the President of the European Commission, and the Bill & Melinda Gates Foundation. The event was joined by the UN Secretary General, the AU Commission Chairperson, the G20 President, heads of state of France, South Africa, Germany, Vietnam, Costa Rica, Italy, Rwanda, Norway, Spain, Malaysia and the UK (represented by the First Secretary of State).

Health leaders from the Coalition for Epidemic Preparedness Innovations (CEPI), GAVI-the Vaccine Alliance, the Global Fund, UNITAID, the Wellcome Trust, the International Red Cross and Red Crescent Movement (IFRC), the International Federation of Pharmaceutical Manufacturers (IFPMA), the Developing Countries Vaccine Manufacturers’ Network (DCVMN), and the International Generic and Biosimilar Medicines Association (IGBA) committed to come together, guided by a common vision of a planet protected from human suffering and the devastating social and economic consequences of COVID-19, to launch this groundbreaking collaboration. They are joined by two Special Envoys:  Ngozi Okonjo-Iweala, Gavi Board Chair and Sir Andrew Witty, former CEO of GlaxoSmithKline.

 

They pledged to work towards equitable global access based on an unprecedented level of partnership. They agreed to create a strong unified voice, to build on past experience and to be accountable to the world, to communities and to one another.

“Our shared commitment is to ensure all people have access to all the tools to prevent, detect, treat and defeat COVID-19,” said Dr Tedros. “No country and no organization can do this alone. The Access to COVID-19 Tools Accelerator brings together the combined power of several organizations to work with speed and scale.”

Health leaders called on the global community and political leaders to support this landmark collaboration and for donors to provide the necessary resources to accelerate achievement of its objectives, capitalizing on the opportunity provided by a forthcoming pledging initiative that starts on 4 May 2020. This initiative, spearheaded by the European Union, aims to mobilize the significant resources needed to accelerate the work towards protecting the world from COVID-19.

 

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Commitment and call to action: Global collaboration to accelerate new COVID-19 health technologies
A Global Collaboration to Accelerate the Development, Production and Equitable Access to New COVID-19 diagnostics, therapeutics and vaccines
24 April 2020
Statement
Our Vision and Mission
Grounded in a vision of a planet protected from human suffering and the devastating social and economic consequences of COVID-19, we, an initial group of global health actors (BMGF, CEPI, Gavi, Global Fund, UNITAID, Wellcome Trust, WHO) and private sector partners and other stakeholders, are launching a landmark, global and time-limited collaboration to accelerate the development, production and equitable global access to new COVID-19 essential health technologies.

We know that as long as anyone is at risk from this virus, the entire world is at risk – every single person on the planet needs to be protected from this disease.

We agree that alongside evidence-based public health measures, innovative COVID-19 diagnostics, therapeutics and vaccines are needed – in record time and at record scale and access – to save millions of lives and countless trillions of dollars, and to return the world to a sense of ‘normalcy’.

We recognize the significant amount of critical work, investment and initiatives already ongoing around the world to expedite the development and deployment of innovative COVID-19 related products and interventions.

We appreciate that while development and deployment of innovative products is essential, it will not be enough. We must simultaneously and urgently accelerate the strengthening of sustainable health systems and capacities to enable delivery of the new COVID-19 tools to those who need them and to mitigate the knock-on impact on other diseases.

We remember lessons from the past, which have shown that even when effective tools are available to the world, too often some are protected, while others are not. This inequity is unacceptable – all tools to address COVID-19 must be available to all. In the fight against COVID-19, no one should be left behind.

We understand we cannot do this alone, and that we need to work together in unprecedented and inclusive partnership with all stakeholders – political leaders, public and private sector partners, civil society, academia, and all other stakeholders across society – jointly leveraging our comparative strengths and respective voices to drive towards collective solutions, an accelerated path, and access for all. We are stronger, faster and more effective working together.

Our Mission is not only accelerated development and availability of new COVID-19 tools – it is to accelerate equitable global access to safe, quality, effective, and affordable COVID-19 diagnostics, therapeutics and vaccines, and thus to ensure that in the fight against COVID-19, no one is left behind.

 

Our Commitment
[1] We commit to the shared aim of equitable global access to innovative tools for COVID-19 for all.
[2] We commit to an unprecedented level of partnership – proactively engaging stakeholders, aligning and coordinating efforts, building on existing collaborations, collectively devising solutions, and grounding our partnership in transparency, and science.
[3] We commit to create a strong unified voice to maximize impact, recognizing this is not about singular decision-making authority, but rather collective problem-solving, interconnectedness and inclusivity, where all stakeholders can connect and benefit from the expertise, knowledge and activities of this shared action-oriented platform.
[4] We commit to build on past experiences towards achieving this objective, including ensuring that every activity we undertake is executed through the lens of equitable global access, and that the voices of the communities most affected are heard.
[5] We commit to be accountable to the world, to communities, and to one another. We are coming together in the spirit of solidarity, and in the service of humanity, to achieve our mission and vision.

 

Our Call
We ask the global community and political leaders to support this landmark collaboration, and for donors to provide the necessary resources to accelerate achievement of the objectives of this global collaboration, capitalizing on the opportunity provided by the rolling pledging campaign that will start on 4 May 2020.

 

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Why the world needs $8 billion now to get us to COVID-Zero
Opinion | 24 April 2020
Jeremy Farrar, Director Wellcome
Only when we have tools to detect, treat and prevent coronavirus disease everywhere, will we be able to stop the pandemic. Developing these tools requires new global partnerships and cooperation.

Science is the only true exit strategy for the COVID-19 crisis. My belief is that this is now an endemic human infection – one that will remain a challenge to the human race from now on.
Physical distancing and lockdown measures can slow the virus and lower the peak. But there has to be a longer-term strategy as well. Only when we have tools to detect, treat and prevent it everywhere, will we be able to stop the pandemic now and in the future.
Researchers around the world continue to make extraordinary efforts to understand the disease and the virus that causes it, as well as bringing forward potential science-based solutions as quickly as possible. We don’t know exactly where the tests, treatments and vaccines that eventually contribute to ending this crisis will come from – wherever that is, we must commit from the start to make them available to everyone who needs them, independent of their ability to pay.

There’s no guarantee that the first vaccines in clinical trials will be the ones we need. In fact, we will need a number of different vaccines. That’s why we can’t afford to wait for the best solution to emerge and then put everything we have behind it.
Instead, to get coronavirus vaccines, treatments and tests for the world, we need to be lining up as many shots on goal as we can to increase the chance of hitting the target as many times as we need in order to win.

For example, there are various ways to go about creating a vaccine. Some are tried and trusted platforms but they can be expensive and typically take about a decade to produce a safe and effective vaccine. Can we speed up and scale up these approaches? Or will it take new platforms that are unproven but, if faster, cheaper, safe and effective, could be game-changers?

We don’t know, of course. So all these potential approaches must get the full support they need. That will include testing in many different countries to determine whether they work for everyone, and making sure the capability is there to produce such a vaccine reliably, quickly and at a scale of billions of doses within a year.

Hitting the target does not mean a vaccine in a vial that’s been given to a few people or is available only to those who can afford it. That won’t work biologically, it won’t work in terms of public health, it won’t end the pandemic. In this case, success demands that the tools science delivers must be available to everyone – that means that the world must have the capacity to make enough kits or doses for everyone who needs them, many billions, and we must be absolutely committed to this from the start.

Funding multiple teams working on different approaches to develop and deliver these tools, and then funding manufacture and distribution to the entire world, means the costs are going to be huge. It will take billions and billions of dollars. Right now, though, even the initial seed funding to get this work up and running is not in place.

Wellcome calculates that the world is at least $8 billion short of what’s needed today. That’s not the final cost – far from it – but what’s required to fund the immediate research, the development of tests, treatments and vaccines, and also to ensure the world has the capacity to manufacture and deliver these tools quickly enough and at the scale required to end this pandemic and protect all of us from future COVID-19 crises.

We urgently need this money to start rolling in fast, at scale, without any thought of a financial return. That kind of funding can only come from governments, global business and philanthropies.

A summit organised by the European Commission on 4 May is exactly what we need to bring these groups together and get the world ready to end the pandemic. Every aspect of our response must be globally coordinated and united, using existing bodies like the World Health Organization and establishing new ones if required, such as the COVID-19 Therapeutics Accelerator (opens in a new tab).

It’s going to be different to anything humanity has ever achieved before. If we do it – and I’m optimistic that we will – the world can come out the other side of this crisis in better shape than we went into it. With new global partnerships and cooperation, enhanced public health, and equitable access to innovation front and centre, we can even be stronger.

 

Vaccines work at all ages, everywhere – WHO

Milestones :: Perspectives :: Research

 

COVID-19 & Immunization

 

Vaccines work at all ages, everywhere – WHO
23 April 2020
Zsuzsanna Jakab, Deputy Director-General, WHO
There’s no question that immunization is one of the greatest success stories in global health, saving millions of lives every year from vaccine-preventable diseases. Every year more than 116 million, or 86% of all infants born are vaccinated – a number than has been holding firm for a decade.

More than 20 life-threatening diseases can now be prevented by immunization, and new vaccines for major killers like diarrhoea, cervical cancer, cholera and meningitis are quickly being introduced in countries that did not use them previously. While, vaccination has routinely prioritized children in the past, today it is increasingly protecting health among people of all ages.

Commitment to research and development has led to developing new vaccines to protect against malaria, typhoid and Ebola, and many more vaccines are under development for emerging diseases, like COVID-19.

All of this is good news. But it also shows the challenges we’re facing as we try to ensure no one misses out on life-saving vaccines.

 

Children still missing out on vaccines
Globally, there are still more than 13 million children who never receive any vaccination. These un-vaccinated children, and millions more under-vaccinated children, are found in all countries but the large majority of them live in a small number of countries which are affected by conflict, poverty and fragility.

It’s difficult to reach these children in normal times and intensive work continues to figure out the most effective ways to find them and assure they are receiving immunization and other essential health services. But now COVID-19 is making it even harder.

Immunization services are being scaled back and, in many cases, shut down. Even when the services are still operating parents and caregivers are forgoing taking their children to routine health visits including for immunization out of concern for risk of COVID-19. When vaccination coverage goes down, inevitably more outbreaks will occur, including of life-threatening diseases like measles and polio.

Our challenge now is to ensure we don’t slide backwards on vaccination coverage in the midst of the pandemic, but instead move beyond 86% coverage and reach everyone, everywhere. This will not only protect the health of children and their communities but will protect the health services from a second wave of diseases for which we have vaccines to prevent.

 

A new vison of immunization
At last year’s Global Vaccine Summit, WHO, the European Commission, governments and partners recognized that to sustain vaccination’s hard-won gains, we need to ensure our health systems are more equitable in their delivery of services.

The new Immunization Agenda 2030 (IA2030) which sets the vision and strategy for 2021-2030, co-created with community organizations, government ministries, partner organizations, academia, vaccine makers, and with non-immunization partners, recognizes universal health coverage (UHC) as essential to immunization success. To improve coverage, IA2030 outlines strategies that are relevant for all countries to break through on stagnation in reaching children not vaccinated and fight against vaccine hesitancy.

It also aims to build stronger surveillance systems for vaccine-preventable diseases, particularly for identifying, tracking, and monitoring disease outbreaks and sustaining research to ensure we are poised to meet the challenges around the corner on outbreaks, antimicrobial resistance, infections for which our vaccines are inadequate; and seize opportunities to tackle diseases for which there are as yet no vaccines.

And, for the first time the new vision expands the global focus for immunization to all age groups, not just children. While this will shift immunization programmes, it will allow us to rethink and strengthen people-centred care to ensure vaccines are taken up by older age groups.

 

Reaching more people with immunization requires investment
As we set new priorities for 2021 and beyond with the vaccine community, we also need to ensure we have sound investment in immunization. Every year, almost 80 million infants require vaccinations in 68 Gavi-supported countries and this is growing.

Gavi has set an ambitious goal to immunize 300 million more children with 18 vaccines by 2025. In order to reach this goal, it will require US$7.4 billion. Gavi’s replenishment is essential towards reaching the hardest to reach, and ensuring vaccination services are equitable. WHO remains committed to ensuring Gavi’s success.

As we mark World Immunization Week, we must continue to champion the message that #VaccinesWork for All, and not let the COVID-19 pandemic compromise hard won immunization gains in the past decades.

Today’s crisis further highlights the need for new vaccine breakthroughs, like we’ve saw in Ebola, to become the norm. Investments in research and development must be escalated with great intensity to fight new and emerging diseases like COVID-19.

Let’s continue to scale-up, not scale-down our immunization services through primary health care and universal health coverage so that everyone, everywhere has access to life-saving vaccines by 2030. #VaccinesWork for All.

 

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Over 13 million children did not receive any vaccines at all even before COVID-19 disrupted global immunization – UNICEF
NEW YORK, 25 April 2020 – As the world waits desperately for a vaccine, the COVID-19 pandemic is continuing to surge across the globe. Millions of children are in danger of missing life-saving vaccines against measles, diphtheria and polio due to disruptions in immunization services. At last count, most countries had suspended mass polio campaigns and 25 countries had postponed mass measles campaigns, as per recommended guidance.

Even before the COVID-19 pandemic, measles, polio and other vaccines were out of reach for 20 million children below the age of one every year. Over 13 million children below the age of one globally did not receive any vaccines at all in 2018, many of whom live in countries with weak health systems. Given the current disruptions, this could create pathways to disastrous outbreaks in 2020 and well beyond.

“The stakes have never been higher. As COVID-19 continues to spread globally, our life-saving work to provide children with vaccines is critical,” said Robin Nandy, UNICEF Principal Adviser and Chief of Immunization. “With disruptions in immunization services due to the COVID-19 pandemic, the fates of millions of young lives hang in the balance.”

An estimated 182 million children missed out on the first dose of the measles vaccine between 2010 and 2018, or 20.3 million children a year on average, according to a UNICEF analysis. This is because the global coverage of the first dose of measles stands only at 86 per cent, well below the 95 per cent needed to prevent measles outbreaks.

Widening pockets of unvaccinated children led to alarming measles outbreaks in 2019, including in high-income countries like the US, UK and France.

Among low-income countries, the gaps in measles coverage before COVID-19 were already alarming. Between 2010 and 2018, Ethiopia had the highest number of children under one year of age who missed out on the first dose of measles, at nearly 10.9 million. It was followed by the Democratic Republic of the Congo (6.2 million), Afghanistan (3.8 million), Chad, Madagascar and Uganda with about 2.7 million each.

Beyond measles, the immunization gaps were already quite dire, according to new regional profiles developed by UNICEF. In Africa, more children have missed out on vaccines over the past years due to rising number of births and a stagnation in immunization services. For example, in West and Central Africa, coverage has stagnated at 70 per cent for DTP3 – which is the lowest among all regions – at 70 per cent for polio, and at 71 per cent for measles. This has led to repeated outbreaks of measles and polio in countries such as the Democratic Republic of the Congo. Meanwhile, in South Asia, an estimated 3.2 million children did not receive any vaccines in 2018. In Eastern and Southern Africa, the number of unvaccinated children has remained almost the same for the last decade, at around 2 million. All regions are now also battling COVID-19 outbreaks.

UNICEF is sending critical vaccine supplies to immunize children, where possible, in areas with outbreaks and to replenish their routine supplies.In the Democratic Republic of the Congo, for example, UNICEF is supporting the Government with vaccine supplies and protective equipment to continue immunization activities in North Kivu province, where over 3,000 cases of measles were reported since January 1. And in Uganda, UNICEF procured 3,842,000 doses of bivalent oral polio vaccine (bOPV) to immunize 900,000 children below the age of one year. Children receive three doses of the polio vaccine before they celebrate their first birthday.

As the world races to develop and test a new COVID-19 vaccine, UNICEF and partners in the Measles & Rubella Initiative and Gavi, the Vaccine Alliance are calling on governments and donors to:
:: Sustain immunization services while keeping health workers and communities safe;
:: Start planning to ramp up vaccinations for every missed child when the pandemic ends;
: Fully replenish Gavi, as the alliance supports immunization programmes in the future;
:: Ensure that when the COVID-19 vaccine is available, it reaches those most in need.

“Children missing out now on vaccines must not go their whole lives without protection from disease,” said Dr. Seth Berkley, CEO, Gavi, the Vaccine Alliance “The legacy of COVID-19 must not include the global resurgence of other killers like measles and polio.”

 

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Statement – Vaccination must be maintained during COVID-19 pandemic to be effective
Statement by Dr Hans Henri P. Kluge, WHO Regional Director for Europe, on the occasion of European Immunization Week  2020

20 April 2020, Copenhagen, Denmark
We are living through an exceptional time, when every one of us has been called upon to prevent the spread of COVID-19. The COVID-19 situation in the European Region remains very concerning.

I want to take the opportunity of European Immunization Week to reiterate that we must not, especially now, let down our guard on immunizations. Access to vaccines for all has transformed our societies, but it is a public good that must be maintained to be effective, even in difficult times. Our overstretched health systems cannot bear any outbreaks of vaccine-preventable diseases.

The health and/or economic consequences of this pandemic are affecting everyone. The most vulnerable, who are often left behind by immunization services, should not suffer the added burden of vaccine-preventable diseases.

Measles affected over 100 000 young and old in this Region last year. This virus has not gone. It will resurge again if we do not do everything in our power to stop it.

As 1 of my 4 flagship areas, prioritizing immunization is central to WHO/Europe’s vision for health in the new European Programme of Work. Immunization is crucial to achieving universal health care and the Sustainable Development Goals, as well as being a vital component of our society that assures health security across the Region.

I therefore take this opportunity to also commend all the ministries of health in this Region for heeding our call and doing everything possible to prioritize routine immunization as part of essential health services during this pandemic. And I thank our tireless health-care professionals, dedicated to leaving no one behind in providing health care and delivering vaccination services.

Vaccination is a right and a responsibility, and it is up to all of us to ensure that we are protected together.

 

NIAID strategic plan details COVID-19 research priorities

Milestones :: Perspectives :: Research

 

COVID-19 R&D

NIAID strategic plan details COVID-19 research priorities
April 23, 2020 —
Urgent public health measures are needed to control the spread of the novel coronavirus (SARS-CoV-2) and the disease it causes, coronavirus disease 2019, or COVID-19.  Scientific research to improve our understanding of the virus and how it causes disease, and to develop strategies to mitigate illness and death, is of paramount importance. A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.

The NIAID Strategic Plan for COVID-19 Research has four key priorities. The first involves improving fundamental knowledge of SARS-CoV-2 and COVID-19, including studies to characterize the virus and better understand how it causes infection and disease. This research includes natural history, transmission and surveillance studies to determine why some individuals experience mild symptoms of infection while others become critically ill. The role of asymptomatic individuals in viral spread and the potential seasonality of viral circulation also need to be explored, according to the report. Additionally, small and large animal models that can recapitulate COVID-19 disease seen in humans must be developed.

NIAID’s second research priority is the development of rapid, accurate diagnostics and assays to identify and isolate COVID-19 cases and track the spread of the virus.  Molecular assays can detect low levels of SARS-CoV-2 and differentiate it from other related viruses. Researchers will work to improve the speed and accuracy of these diagnostic assays to mitigate the spread of the disease during the current outbreak and any future ones. Additionally, new and improved serologic assays to detect antibodies to the virus must be developed to enhance surveillance efforts and identify individuals who may have resolved a previous COVID-19 infection.

The third research priority is characterizing and testing potential treatments for COVID-19. These efforts will include identifying and evaluating drugs already approved for other conditions that could be repurposed to treat COVID-19 and testing novel broad-spectrum antivirals, such as remdesivir; virus-targeted antibody-based therapies; monoclonal antibodies; and host-directed strategies to target an individual’s immune response to the virus. To optimize findings during the pandemic, multiple clinical trials will be conducted in parallel among various patient populations, including hospitalized people and outpatients.

NIAID’s fourth research priority is to develop safe and effective vaccines to protect individuals from infection and prevent future SARS-CoV-2 outbreaks.  NIAID researchers and their collaborators are adapting vaccine candidates and approaches previously employed to address the related Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) coronaviruses and applied them to the current pandemic. For example, NIAID recently launched a Phase 1 clinical trial using a vaccine platform initially developed to target MERS. NIAID will use its broad clinical trial infrastructure to advance experimental vaccines through Phase 1 safety and dosing testing and simultaneously plan for advanced clinical testing of the most promising candidates. The institute will work with government partners to ensure that any safe and effective vaccine will be manufactured in sufficient quantities to allow expedient distribution to those at highest risk for infection.

To achieve its four priorities, NIAID will build on its current resources, research programs, clinical trials networks and collaborations with other U.S. government agencies and other key U.S. and global partners. The new strategic plan aligns with priorities set by the White House Coronavirus Task Force and represents a comprehensive and coordinated effort to develop effective biomedical tools to combat COVID-19.

Publication: NIAID Strategic Plan for COVID-19 Research

 

IFPMA Statement on the launch of a new global collaboration to accelerate the development, production and equitable access to new COVID-19 tools :: Pharma industry body joins as founding partner a new global collaboration to accelerate the development :: IFPMA Backgrounder – COVID-19 ::

Milestones :: Perspectives :: Research

 

IFPMA Statement on the launch of a new global collaboration to accelerate the development, production and equitable access to new COVID-19 tools
Geneva, 24 April 2020
Statement delivered by: Thomas Cueni, Director General, IFPMA
The biopharmaceutical industry is acutely aware of the enormous responsibility we have to patients and society to engage in unprecedented levels of collaboration to find a solution to COVID-19. We stand ready to bring to this partnership our unique knowledge and expertise in the discovery and development of medicines and vaccines, as well as our experience building manufacturing capacity and distribution networks. Today, scientists in the public and private sector hold the keys to our common goal: The swift end of the COVID-19 pandemic. We are proud to be part of this landmark global partnership and are fully committed to its goal to accelerate development, production and equitable global access to safe, quality, effective, and affordable COVID-19 therapeutics and vaccines. In the fight against COVID-19, we must ensure that no one is left behind. We will only succeed in this journey together.

Pharma industry body joins as founding partner a new global collaboration to accelerate the development,
Geneva, April 24, 2020: The world’s leading biopharmaceutical companies proclaimed their commitment to a landmark global partnership launched today and designed to accelerate the development and production of safe, effective and affordable therapeutics and vaccines available for all in a way that ensures nobody is left behind in the fight against COVID-19. The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the body representing the innovative biopharmaceutical industry in Geneva, will join the global collaboration as a Founding Partner to represent industry.

The industry has been working flat-out to marshal its unique expertise to find a durable solution to the spread of COVID-19 and stands ready to scale up its work on an even more unprecedented scale in line with its previously expressed commitments. By joining the global collaboration, the innovative biopharmaceutical industry can work on an equal footing with all stakeholders to help speed up the development of safe and effective therapeutics and vaccines, share tools and insights to test potential therapies and vaccines, increase manufacturing capabilities and share available capacities and share real-time clinical trial data with governments and other companies around the world.

This collaboration is aligned with the innovative biopharmaceutical companies’ strong sense of responsibility to act together as well as in partnership with all stakeholders but also their determination to play the greatest possible role in the global response to the COVID-19 pandemic. The biopharmaceutical industry holds the keysto finding lasting and equitable solutions through new therapeutics and vaccines. Industry welcomes today’s acknowledgment of the critical role of the private sector in this fight..

 

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IFPMA Backgrounder – COVID-19
24 April 2020
[Editor’s Note:
IFPMA has re-organized its recurring “Backgrounder” providing an inventory of company initiatives involving development of vaccines, treatments and diagnostics under the categories below. Each category inventories company by company activity and we provide detail on vaccine-related activity. We recognize that some of the text may sound promotional.]

REPURPOSE EXISTING & TEST OF NEW TREATMENTS
As of 14 April 2020, the WHO’s landscape analysis of potential treatments for COVID-19 contains 133 therapeutics. Further, the WHO Solidarity Trial has brought together over 100 countries working together to find effective therapeutics for COVID-19 as fast as possible. IFPMA members have also been reviewing their drug portfolios, which involves scientists searching for potentially useful assets that could help with the development of new or repurposed treatments to fight against the novel coronavirus.

 

SHARE REAL-TIME CLINICAL TRIAL DATA WITH GOVERNMENTS & OTHER COMPANIES
The rapid virus sequencing by the scientific community enabled researchers to characterize and begin to understand the new threat posed by COVID-19. “Open Access” data-sharing channels are the backbone to securing a response capacity and have proven their worth with influenza networks. The rapid pace with which researchers have been able to understand this novel strain of virus and get medicines into human clinical trials is a testament to the lessons learned from past public health emergencies. The Global Initiative on Sharing All Influenza Data or GISAID Initiative, an open access platform partly funded by the private sector, played a critical role in sharing the first genome sequences of the novel coronavirus and centralizing their collection. This has proven vital in speeding up the sharing of information among scientists as well as public health authorities. But there is still a lot to learn about the virus, both in terms of how it spreads as well as what existing treatments may be effective in helping patients who contract the disease.

 

SPEED UP R&D OF SAFE & EFFECTIVE VACCINES
As of 23 April 2020, the WHO reports there are currently 6 candidate vaccines in clinical evaluation and 77 candidate vaccines in preclinical evaluation. Several biopharmaceutical companies are researching vaccine candidates for the prevention of COVID-19 and collaborating in the sharing of existing technologies that can be leveraged to allow a rapid upscale of production once a vaccine candidate is identified. IFPMA members are also sharing technologies that act as an adjuvant which can boost the effectiveness of a potential vaccine.
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 and complete three phases of clinical trials 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 greater the chance of success.
CSL/ Seqirus provides scientific and technical expertise together with its established MF59® adjuvant technology to the University of Queensland in Australia to fast-track R&D of their CEPI-funded COVID-19 vaccine candidate, which uses novel molecular-clamp technology
GSK is partnering with Chinese biotech company Clover Biopharmaceuticals, providing it with its proprietary adjuvants which enhance the effectiveness of vaccines.
GSK is also collaborating with CEPI to help the global effort to develop a vaccine for the novel coronavirus. GSK is making its adjuvant technology available to support rapid development of candidate vaccines and is working with The University of Queensland, Australia.
GSK is collaborating with Innovax and Xiamen University, developing and testing a recombinant protein-based coronavirus vaccine candidate.
By mid-March, GSK further expanded collaborations to five partner companies and research groups across the world, including in the USA and China.
GSK entered into a collaboration with Sanofi to develop an adjuvanted vaccine for COVID-19, using innovative technologies from both companies. The vaccine would be ready to begin testing in humans in the second half of 2020.
Johnson & Johnson expanded its collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and established a new collaboration with Beth Israel Deaconess Medical Center (BIDMC).
Johnson & Johnson and partners announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020. It is planning to rapidly scale up its manufacturing capacity with the goal of providing global supply of more than one billion doses.
Pfizer and BioNTech have entered into a partnership to jointly develop BioNTech’s mRNA-based vaccine candidate BNT162 to prevent COVID-19 infection. The two companies plan to jointly conduct clinical trials initially in the United States and Europe across multiple sites by the end of April 2020. On April 22, the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/2 clinical trial for BioNTech’s BNT162 vaccine program to prevent COVID-19 infection
Sanofi announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to advance a novel COVID-19 vaccine candidate. Work is underway to leverage previous development efforts of a SARS vaccine candidate using Sanofi’s recombinant DNA technology.
Sanofi, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, will collaborate to develop a novel mRNA vaccine for COVID-19. This collaboration leverages an existing agreement from 2018 between the two companies to develop mRNA vaccines for infectious diseases.
Sanofi joined forces with GSK, sharing innovative technologies from both companies. For more details see GSK.
Shionogi’s subsidiary UMN Pharma Inc. is pursuing the discovery and development of a recombinant protein vaccine in a project supported by the Japan Agency for Medical Research and Development (AMED).
UCB is collaborating with The University of Oxford on a vaccine development.

 

DEVELOP DIAGNOSTIC TESTING & SECURE CONTINOUS SUPPLY
Rolling out diagnostics to detect whether patients are genuinely infected with the new coronavirus is a key step in preventing or slowing its spread. However, the rapid spread of COVID-19 has drastically increased the demand for testing kits around the world and governments are trying to ramp up their testing capacities. The biopharmaceutical industry is therefore pushing the boundaries, uniting and collaborating to increase and secure the production and development of diagnostics for COVID-19.

 

SECURE ESSENTIAL SUPPLIES FOR MEDICINES & VACCINES
IFPMA and its member companies are monitoring the impact the SARS-CoV2 outbreak and measures put in place by governments to prevent the spread of the virus (e.g. restrictions on travel, movement, border closures or measures on supply chain). Member companies are committed to ensure the continued supply of essential supplies for medicines and vaccines, for patients that suffer from chronic illnesses or other health conditions. Member companies are not aware of any near-term impacts on the availability of medicines and vaccines. They are continuously monitoring and proactively handling the situation as it develops and do currently not expect any long-term impact on the availability of medicines and vaccines, unless any disruption caused by the pandemic is sustained over the next several months.
Biopharmaceutical companies are working to prevent and mitigate any shortages through close coordination with national regulatory authorities and other global stakeholders, including the World Health Organization.
AbbVie is not anticipating disruption to the medicine supply for HIV patients as a result of the investigation of the effectiveness of HIV medicines against COVID-19.
Almirall will continue production of all its essential products and has increased production of specific medicines, such as paracetamol.
Bayer is continuing the production of medicines and health care products at their plant in Garbagnate, Italy for both the Italian and global market.
Biogen take the vital role they play in ensuring an uninterrupted supply of their medicines to patients very seriously. It does not anticipate any interruptions but cannot exclude the possibility that COVID-19 might have an impact on manufacturing capabilities in the future.
Boehringer Ingelheim ensures further discovery, development, production and supply of highly innovative medicines that are needed by patients around the globe.
Clinical and commercial supply chain teams at Bristol Myers Squib have proactively made sure raw materials and products reach their markets and clinical sites. It has not seen any disruption in its clinical or commercial supply chain due to the pandemic.
Chiesi Group will continue the production of all medicines without interruption at sites in Italy and abroad at the same high-quality standards. Currently, it is able to deliver medicines under normal production and distribution channels from all production plants in Italy, Brazil and France.
Seqirus has enacted its business continuity plans across the globe to minimise disruption to the manufacture and on-time supply of its influenza vaccines.
Daiichi-Sankyo announced it has not any shortage of its medicines. Its Supply Chain team is monitoring the evolving situation very carefully to maintain supply and delivery of these medicines.
Eisai maintains necessary stocks for the stable supply of medicines in addition to the stable production of medicines.
Eli Lilly launched the Lilly Insulin Value Program in the US allowing anyone with commercial insurance and those without insurance to fill their monthly prescription of Lilly insulin for $35.
Grünenthal is not experiencing any significant supply shortages. If their team detects any severe supply shortages that might potentially disrupt the supply of their products, affected partners will be informed as soon as possible.
Ipsen is closely working with national and international supplies to monitor the provision of goods and services, with the goal of continuing operations as seamlessly as possible. It does not anticipate any supply shortages.
LEO Pharma has activated business continuity plans to uninterruptedly supply patients with the medicines they need. LEO Pharma is taking additional measures to avoid any shortages of medicines or raw materials and to mitigate any interruptions.
Lundbeck has been extremely busy with taking precautions to provide treatments to the millions of people relying on them. Its supply chain remains intact and it has not experienced any supply disruptions.
Merck will continue to ensure access to Merck medicines at no cost for eligible patients (who have lost their jobs and health insurance coverage due to the pandemic) through its Merck Patient Assistance Program. Merck will also be making changes to other U.S. access and assistance programs due to the COVID-19 pandemic, including a temporary $0 co-pay for certain products for eligible privately insured patients who are enrolled in the Merck Access Program.
Merck and The Jenner Institute announced they have laid the foundation for large-scale production of The Jenner Institute’s COVID-19 vaccine candidate, ChAdOx1 nCoV-19. Their joint team reduced process development time to two months from a year.
Novartis will continue to deliver their medicines to patients around the world and does not anticipate supply chain disruptions at this time.
Sandoz, the Novartis generics and biosimilars division, is maintaining prices on a basket of essential medicines that may help in the treatment of COVID-19.
Novartis encourages industry, governments and international institutions to work together to ensure adequate global access of medications to treat COVID-19 patients.
Novo Nordisk is ensuring the supply of their lifesaving medicines to people with serious chronic diseases across the globe. Novo Nordisk is applying its experience with Chinese lockdown measures around the globe to assure continuity of their supply chain
Roche is doing everything possible to ensure an adequate supply of their medicines. It calls upon governments to work with the industry to keep global manufacturing and supplies running by ensuring the free flow of vital goods across national borders, consider pragmatic temporary adjustments to regulations on packaging, reviews, customs etc. and to work together across governments internationally.
Sanofi to provide hydroxychloroquine (Plaquenil®) wherever possible and will secure appropriate supply levels of current approved indications.
Servier puts its best efforts forward to ensure the continuity of its production in order for its medicines to remain available to patients who rely on them. It therefore brings its expertise to the multi-stakeholder partnership “Health Innovation Coalition – Health Crisis” in France.
Teva is prepared for various scenarios and has inventory and redundancy plans in place to address potential shortfalls, if necessary. The supply chain for their key products, brand, generics and APIs remains largely uninterrupted with adequate inventory of products.

 

INCREASE & SHARE MANUFACTURING CAPACITY FOR MEDICINES & VACCINES
Biopharmaceutical companies are part of a wider research community which is collaborating to fast-track the development of therapeutics and new vaccines. Collaborating in this way could speed up development of resources to tackle this outbreak. It creates networks of centres of excellence that can deliver a real impact and a preparedness infrastructure which can be mobilized for future outbreaks. While there are still many unknowns about the virus, companies are entering in partnerships to scale-up production capacity.
Eli Lilly and AbCellera collaborate on AbCellera’s rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform Program, and Lilly’s global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies.
Under GSK and Sanofi vaccine development collaboration, both companies commit to create and supply sufficient quantities of vaccines that will help stop this virus. Both companies bring significant manufacturing capacity, and, if successful, we will be able to make hundreds of millions of doses annually by the end of next year.
Gilead has accelerated manufacturing of remdesivir at risk, in anticipation of potential future supply needs.
Johnson & Johnson announced plans to scale up its global manufacturing capacity with a goal of providing 1 billion doses of a safe and effective vaccine globally for emergency pandemic use on a not-for-profit basis.
Pfizer and BioNTech are jointly developing a COVID-19 vaccine, to be produced initially in the US and Europe. Manufacturing capacity will be scaled-up to support global supply. Pfizer will contribute its leading global vaccine clinical R&D, regulatory, manufacturing and distribution infrastructure and capabilities.
Pfizer is committed to use any excess manufacturing capacity and to potentially shift production to support others in rapidly getting life-saving breakthroughs into the hands of patients as quickly as possible.
Sanofi increased production capacity of hydroxychloroquine (Plaquenil®) by 50% and is on track to further increase production over the coming months.
Under Sanofi and GSK vaccine development collaboration, both companies commit to create and supply sufficient quantities of vaccines that will help stop this virus. See GSK for more details.
Teva is assessing additional production of hydroxychloroquine sulfate tablets with materials that are being sent to Teva from its ingredient supplier.
Teva’s global manufacturing network has been working tirelessly on securing and scaling production of both API and finished doses for potential treatments that my prove essential in treating COVID-19 everywhere Teva does business. UCB is assuring a reliable supply of medicines in every market it has a commercial presence in. It has not experienced shortages for any of our products due to this epidemic.

 

SUPPORT GLOBAL HEALTHCARE SYSTEMS
IFPMA member companies are committed to support health care system capacities and protect health care workers, particularly in the most hard-hit countries and vulnerable countries which are ill prepared to cope with an accelerating outbreak of COVID-19. When the novel coronavirus first emerged in Wuhan, China, IFPMA and its member companies started working with their teams on the ground, and with the Chinese authorities to ensure people can get access to necessary health care services. Given the spread of the virus to other regions across the world, IFPMA member companies have stepped up these efforts and are donating personal protective equipment and financial resources to ease the burden on health care systems. Company employees are also volunteering in community efforts to relieve the burden on healthcare systems.

 

FACTS & FIGURES
:: Number of IFPMA member companies involved in R&D for COVID-19 therapeutics, vaccines and diagnostics: at least 20 of IFPMA member companies are involved in COVID-19 focused R&D efforts
:: Number of clinical trials initiated/ supported by IFPMA member companies: 25 clinical trials evaluating the effectiveness of therapeutics for COVID-19
:: Average number of people enrolled in clinical trials by IFPMA members: On average with 350 participants (except the large-scale Gilead trials + Teva trial which all have above 1000 participants)
:: Value of monetary donations from IFPMA member companies: stands at least at $614 million to date
:: Value of non-monetary donations, such as medicines, personal protective equipment: stands at least at $38 million to date
:: Units of non-monetary donations, such as medicines, personal protective equipment: 25 million units of medicines, face masks, gloves, disinfectants, and the like

 

PhRMA: New report shows nearly 260 vaccines in development, including dozens for COVID-19

Milestones :: Perspectives :: Research

 

PhRMA: New report shows nearly 260 vaccines in development, including dozens for COVID-19
Andrew Powaleny | April 23, 2020
…Today, biopharmaceutical companies are working with stakeholders across the research and development (R&D) ecosystem to develop new ways of preventing and treating illnesses with innovative vaccines. According to a new report, there are currently 258 vaccines in development for the treatment or prevention of disease.

Among the vaccines in development are:
:: 108 vaccines for cancer, including a therapeutic vaccine for non-small cell lung cancer, which uses messenger RNA to mobilize the patient’s own immune system to fight the tumor(s)
:: 125 vaccines for infectious diseases, including a vaccine designed to prevent HIV infection by teaching a patient’s immune system to recognize and effectively fight the virus
:: 14 vaccines for allergies, including vaccines that target peanut allergies
:: 2 vaccines for Alzheimer’s disease, including one therapeutic vaccine that targets amyloid beta protein, which is linked to the development of the neurological disorder

Additionally, numerous different types of potential vaccines are in development that target COVID-19. Researchers are working around the clock amidst the global pandemic to develop safe, effective and affordable vaccines that will prevent both individual infection and the continued spread of the virus. As of April 15, 2020:
:: There are more than 70 vaccines for COVID-19 in the global research pipeline.
:: And six vaccines for COVID-19 have entered human clinical trials with many planning to begin human trials this year…

 

Coronavirus [COVID-19]

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, the WHO’s authoritative guidance is available here:
:: 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

Situation report – 96 [WHO]

Novel Coronavirus (COVID-19)
25 April 2020
[Excerpts]
SITUATION IN NUMBERS
Globally
2 719 897 confirmed (93 716)
187 705 deaths (5767)

European Region
1 314 666 confirmed (30 450)
119 463 deaths (2940)

Region of the Americas
1 047 508 confirmed (52 138)
53 103 deaths (2520)

Eastern Mediterranean Region
154 971 confirmed (5676)
6750 deaths (142)

Western Pacific Region
141 470 confirmed (1688)
5906 deaths (37)

South-East Asia Region
41 073 confirmed (2501)
1658 deaths (104)

African Region
19 497 confirmed (1263)
812 deaths (24)

WHO RISK ASSESSMENT
Global Level – Very High

HIGHLIGHTS
:: WHO, together with heads of state, global health leaders, private sector partners and other stakeholders launched the Access To COVID-19 Tools (ACT) Accelerator, a global collaboration to accelerate the development, production and equitable access to new COVID-19 diagnostics, therapeutics and vaccines. More information including the WHO Director General’s opening remarks, full list of participants, and the group’s statement, are available.

:: Although some governments have suggested that the detection of antibodies to SARS-CoV-2, the virus that causes COVID-19, could serve as the basis for an “immunity passport” or “risk-free certificate”, there is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection. More information is available here.

:: WHO has seen a dramatic increase in the number of cyber-attacks directed at its staff, and email scams targeting the public. WHO asks the public to remain vigilant against fraudulent emails and recommends using reliable sources to obtain factual information about COVID-19 and other health issues. More information is available here.

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“Immunity passports” in the context of COVID-19
WHO Scientific Briefs
24 April 2020
WHO has published guidance on adjusting public health and social measures for the next phase of the COVID-19 response.1 Some governments have suggested that the detection of antibodies to the SARS-CoV-2, the virus that causes COVID-19, could serve as the basis for an “immunity passport” or “risk-free certificate” that would enable individuals to travel or to return to work assuming that they are protected against re-infection. There is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection.

The measurement of antibodies specific to COVID-19
The development of immunity to a pathogen through natural infection is a multi-step process that typically takes place over 1-2 weeks. The body responds to a viral infection immediately with a non-specific innate response in which macrophages, neutrophils, and dendritic cells slow the progress of virus and may even prevent it from causing symptoms. This non-specific response is followed by an adaptive response where the body makes antibodies that specifically bind to the virus. These antibodies are proteins called immunoglobulins. The body also makes T-cells that recognize and eliminate other cells infected with the virus. This is called cellular immunity. This combined adaptive response may clear the virus from the body, and if the response is strong enough, may prevent progression to severe illness or re-infection by the same virus. This process is often measured by the presence of antibodies in blood.

WHO continues to review the evidence on antibody responses to SARS-CoV-2 infection.2-17 Most of these studies show that people who have recovered from infection have antibodies to the virus. However, some of these people have very low levels of neutralizing antibodies in their blood,4 suggesting that cellular immunity may also be critical for recovery. As of 24 April 2020, no study has evaluated whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans.

Laboratory tests that detect antibodies to SARS-CoV-2 in people, including rapid immunodiagnostic tests, need further validation to determine their accuracy and reliability. Inaccurate immunodiagnostic tests may falsely categorize people in two ways. The first is that they may falsely label people who have been infected as negative, and the second is that people who have not been infected are falsely labelled as positive. Both errors have serious consequences and will affect control efforts. These tests also need to accurately distinguish between past infections from SARS-CoV-2 and those caused by the known set of six human coronaviruses. Four of these viruses cause the common cold and circulate widely. The remaining two are the viruses that cause Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome. People infected by any one of these viruses may produce antibodies that cross-react with antibodies produced in response to infection with SARS-CoV-2.

Many countries are now testing for SARS-CoV-2 antibodies at the population level or in specific groups, such as health workers, close contacts of known cases, or within households.21 WHO supports these studies, as they are critical for understanding the extent of – and risk factors associated with – infection.  These studies will provide data on the percentage of people with detectable COVID-19 antibodies, but most are not designed to determine whether those people are immune to secondary infections.

Other considerations
At this point in the pandemic, there is not enough evidence about the effectiveness of antibody-mediated immunity to guarantee the accuracy of an “immunity passport” or “risk-free certificate.” People who assume that they are immune to a second infection because they have received a positive test result may ignore public health advice. The use of such certificates may therefore increase the risks of continued transmission. As new evidence becomes available, WHO will update this scientific brief.
Citations/References at title link above

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