Catarina Luís, PhD 

Communication Manager, European Vaccine Initiative

Ole Olesen, PhD 

Executive Director, European Vaccine Initiative

Global partnerships are essential for accelerated development of urgently needed vaccines. 

The COVID-19 pandemic has sorely reminded us that there is no time to lose when developing vaccines for a world in desperate need.

Given the complexity and interdisciplinarity of vaccine development, international research collaboration has proven key for overcoming the scientific, financial and social challenges it involves.

Product development partnerships – a global approach to worldwide problems 

The fast-track development of vaccines for COVID-19 and Ebola has illustrated the importance of global collaboration for swift development of vaccines.  

Even before these outbreaks, international partnerships have been the preferred model for developing new or improved health tools. This is especially true for diseases disproportionally affecting low-and middle-income countries, and whose solutions lack commercial incentives. 

Product development partnerships (PDPs) are non-profit organisations that started emerging in the 1990’s. International, cross-sectorial partnerships are their basis, involving public research institutions, private sector, governments, and civil society – including partners from affected countries.

PDPs facilitate vital projects, such as one of the current projects by the European Vaccine Initiative (EVI) which undertakes the clinical testing of a vaccine candidate for a stigmatising skin disease called post kala azar dermal leishmaniasis (PKDL). 

Coordinated by EVI, partners from United Kingdom, Sudan, Uganda, Kenya and Ethiopia are teaming up to evaluate the safety and efficacy of this vaccine for preventing PKDL.

The fast-track development of vaccines for COVID-19 and Ebola has illustrated the importance of global collaboration for swift development of vaccines.  

Feeding two or more birds with one seed

Research into individual vaccines, albeit essential, is only part of the puzzle. Other initiatives are needed that can have a more wide-spread and transformative impact on vaccine development.  

One of them is TRANSVAC, an initiative that aims to establish a sustainable, disease-overarching vaccine infrastructure and that is supported by more than +20 leading research organisations from across Europe.  

Such an infrastructure will allow to pool and leverage existing resources, technologies and other tools, creating synergies that truly convert it into an accelerator of vaccine development.  

In times when some may choose to build barriers; building alliances, sharing ideas and resources across disciplines, borders and cultures not only fosters better innovation and faster progress, but also a more resilient society.

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Richard Hughes IV

Managing Director, Avalere Health

Ensuring the highest possible vaccine uptake across the population of the US requires navigating the fragmented nature of the country’s healthcare coverage and delivery system.

“I’ve worked in vaccines for around 15 years,” says Richard Hughes, Managing Director and the Vaccines Leader at Avalere Health, a Washington DC-based advisory firm specialising in strategy, policy, and data analysis for life sciences, health plans, and providers.

“I’ve observed many opportunities to provide better vaccine access, and the COVID-19 pandemic really underscores their value in preventing major outbreaks and why access to them is so vital.”

US vaccine access challenges

One of the challenges for ensuring equitable vaccine access in the US, explains Hughes, is the fragmented nature of the country’s healthcare coverage and delivery system.

For instance, the Affordable Care Act (ACA), passed in 2010, requires that commercial health insurers cover recommended vaccines with zero cost-sharing. This means that nearly everyone with private health insurance in the US has better vaccine access.

Seniors in the US, aged 65-plus, have access to the flu and pneumococcal vaccines without cost sharing, under the Medicare physician benefit (Medicare Part B). However, other vaccines for seniors are covered under the Medicare drug benefit (Medicare Part D), which has variable cost-sharing levels across plans. “Absent supplemental coverage, seniors may pay an average of $50 out of pocket for vaccines under Part B,” says Hughes.

The traditional Medicaid programme, which covers those with limited income and resources who are often more vulnerable to health issues, has variable vaccine coverage and cost-sharing requirements across states.

Overcoming barriers to vaccination access

“Since the ACA passed, significant headway has been made to address financial barriers to vaccination, namely coverage and cost-sharing,” says Kelly Cappio, Associate Principal at Avalere Health.

“However, many Americans still experience coverage gaps and prohibitive out-of-pocket costs. Policymakers could consider ways to achieve parity across the private and public insurance markets – including covering vaccines the same, across sites of care, and eliminating patient cost sharing.”

These challenges require sophisticated solutions to overcome them – systems to connect patients to access or ensure providers are reimbursed – or, ultimately, policy reform to resolve the fragmentation of vaccine coverage and access

Additionally, “The US ACIP’s (Advisory Committee on Immunization Practices) increasingly complex recommendations have become more challenging for payers to implement and for providers to communicate, possibly leading to missed opportunities to protect a patient” says Hughes. “ACIP recommendations could be clearer. The vaccine pipeline is robust. And with new emerging non-vaccine technologies emerging, there’s also an opportunity for the ACIP to advise on the use of novel products that effectively play the same role as a vaccine.”

How COVID-19 will change the development of vaccines

With respect to a COVID-19 vaccine, “The ACIP will likely have a crucial role to play here,” says Cappio. “Given the urgent need, a vaccine may be deployed pre-licensure under an Emergency Use Authorisation by the Food and Drug Administration (FDA).

“Typically, the ACIP doesn’t make a recommendation for use of a vaccine before it receives FDA licensure; but, in extraordinary circumstances, the committee is able to provide guidance on the use of unlicensed vaccines and there is a likelihood they recommend that certain subgroups, like healthcare workers, receive the vaccine first. Later, when the vaccine is available for broader use, ACIP would need to determine whether to recommend it to the wider US population.”

The US Congress took legislative steps in March to ensure access to future COVID-19 vaccines, requiring the vaccine to be covered under the Medicare physician benefit with zero cost-sharing and providing enhanced federal funding for state Medicaid programmes that cover the vaccines at first dollar. Should the ACIP recommend the vaccine for use, commercial plans will also be required to cover it.

Hughes expects the COVID-19 crisis to have a long-lasting impact on vaccine development. “More broadly, this pandemic is likely to shape the long-term healthcare and public health outlook in many ways for good. If there’s any silver lining at all, it’s that.”

Click here to read more from Avalere.

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The COVID-19 pandemic means that it’s more important than ever to minimise sources of variability in the assay – or, quality control – process, and so lead to the design of a better, more robust product.

The vaccine sector is highly regulated, notes Dr Nathaniel Hentz, Director of Scientific Market Development at Artel, a company that offers products, services, and expertise to help life science labs meet their objectives for quality, productivity and compliance.  

“Vaccine developers are obliged to follow regulations and established procedures,” he says. “The problem is, there is guidance for how to validate an assay, but no guidance is available to tell them how to build a proper assay; yet the quality of the assay is what drives the quality of the entire manufacturing process.

“If it isn’t done correctly it may mean a vaccine batch inappropriately passes or inappropriately fails. This could have a direct impact on patient safety, which is always the industry’s number one concern.”

Unfortunately, assays are only as good as the tools that are used to assemble them, and thus subject to different sources of variability.

“An assay is built using many components,” says Dr Hentz. “Take liquid handling, for example, a series of steps that move liquids from point A to point B. This can be done with an automated system, or by scientific staff pipetting by hand. But, if pipetting techniques are different — particularly if multiple analysts are working on the same assay in different laboratories — then operator to operator inconsistency can occur.”

Employing measuring tools, methods and training to minimise sources of variability

Liquid handling is just one source of variability in the assay process. Others include mixing, labware, plate-washing, time, temperature, etc.

However, measuring tools, methodologies and training are available to help labs understand and minimise all sources of variability.

“By using a process optimisation approach during assay development and validation, the entire assay process can be optimised to its fullest extent,” says Dr Hentz. “This can lead to the design of a much better, more robust assay.”

In the scramble to find a vaccine for COVID-19, assay optimisation and quality assurance is more important than ever.

“The increased manufacturing capacity requires more samples to be tested, which in turn increases opportunities for error and that can be a challenge for labs.

“Companies don’t want vaccine batches to fail because this costs them time and money and can impact the introduction to market and adoption of vaccination. Ultimately, it all comes back to patient health and safety, which is why companies are so keen to ensure product quality throughout the manufacturing process. Now, because of COVID-19, things are moving very fast, so it is important to minimise variability and any easy-to-fix mistakes.”

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The impact of COVID-19, still tragically being felt, brings to the fore the potentially devastating effects of diseases for which there is no prevention or cure. The focus now is on finding a vaccine or treatment in response to a pandemic that has been overwhelming.

It is unlikely that this will be the last new virus we see. The progress we make today, the investments we make in science, social care and strong public-private partnerships, and the value we place on prevention will be vital in helping us to respond to future crises and protect populations against diseases and their impact.

Collaboration is essential

I can’t help but be inspired by the scientific collaboration across borders and the speed of innovation during this time of crisis. According to the London School of Hygiene & Tropical Medicine, there are already 119 vaccine candidates in active development across more than eight different vaccine types; 110 in pre-clinical development, eight in Phase I, and one in Phase II.^* Of these, over 40% are collaborative efforts making it likely that the goal of developing a vaccine will be achieved through collective efforts. Continued cooperation with governments, fellow pharmaceutical and biotechnology companies, and international agencies to accelerate the development of these vaccine candidates and identify others is imperative. I’m immensely proud to work for a company that cares about doing the right thing and as such is working closely with organisations including Translate Bio, the Biomedical Advanced Research and Development Authority (BARDA), the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill and Melinda Gates Foundation, and the European Medicines Agency (EMA). In addition, we have joined forces with GlaxoSmithKline (GSK) to pool resources and explore every opportunity to accelerate the development of a candidate vaccine.

Community comes first

The World Health Organization (WHO) recently stated that disruption to immunisation programmes during a pandemic can result in an increase in vaccine-preventable diseases (VPDs) and that such outbreaks could result in VPD-related deaths, increasing the burden on health systems already strained by the pandemic response. This situation has undoubtedly heightened awareness of the importance of disease prevention and the value of vaccination. Despite the worry and uncertainty, we must continue to show our commitment to our communities, not only by taking measures to slow the spread of the novel coronavirus but also by helping to prevent the resurgence of vaccine-preventable infectious diseases.

Looking ahead

The values of solidarity, innovation and collaboration that define our response to this pandemic must, and will, continue to underpin the work we do.

We must continue to recognise the value of vaccination to public health. The new partnerships forged in the context of the pandemic have demonstrated the essential value of collaboration and this must form the foundation of scientific progress. As a company we are calling for the establishment of the European equivalent of BARDA, which may help increase incentives for proactive vaccine research and development. Governments must also continue to invest in innovative new vaccines, guided by the evidence and recommendations of scientific bodies, and make concerted efforts to drive uptake.

Vaccines are one of the most important tools we have in our arsenal to help protect the health of people and communities worldwide. The lessons we take forward can strengthen our collective ability to do this.

^*All figures correct at time of publication

This article was commissioned and written by Sanofi UK
Document number: MAT-UK-2000461 | Date of Preparation: April 2020

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Leading vaccine expert Adrian Wildfire outlines the changes needed to ensure more vaccines coming into the market do ‘what they say on the tin’.

Discussing the immediate need for more effective vaccines – designed to combat seasonal epidemics like influenza and the SARS-CoV-2 epidemic currently circling the globe – has perhaps never been so timely.

In some respects, this was seen before with the SARS outbreak in 2003 and Swine Flu in 2009/10 – yet vaccine efficacy for influenza has been in steady decline since 2005.

“There is a long-standing issue with seasonal epidemic influenza, the biggest threat to human health on a yearly basis,” notes Adrian Wildfire, SGS Life Sciences’ Scientific Director.

“It’s concerning that ourvaccine industry is struggling to provide a product which gives the population the necessary protective index. More research should happen at the pre-clinical and early clinical modelling.”

“There is only 15%* efficacy for some strains of influenza, an all-time low and an indication of where the industry is at currently.”

Why are vaccines failing, you may ask? The picture as to why our current vaccines simply aren’t  improving fast enough is complex.”

Vital measures of ‘real-world’ efficacy are often overlooked. Can the vaccine block transmission by reducing shedding and, for those infected, do they remain well?

There are 2 ways of measuring vaccine success:

• does the patient get better?
• does the virus disappear?

“You want the pathogen health to be as bad as possible and the host health to be as good as possible – you can often best measure these in human challenge studies.”

Vaccination programmes, should be measured on whether the numbers of people catching the virus are going down and whether patient symptomology decreases across the board.

“It’s known that once an infected person is ill enough to require admitting to hospital, the chances of severe disease and death climbs dramatically. Measuring recovery rates here is not very representative of a vaccine’s efficacy.

In the SGS Clinical Patient Unit, we model lots of new approaches to tackle infectious diseases. We can measure endpoints for both viral and host efficacy in healthy individuals who do not have co-infections or co-morbidities, and provide a clearer picture of likely outcomes in the community. New ways of delivering vaccines to patients, such as crystal patches attached to the skin, may well enable inoculation en masse to be simplified in future, and are easy to model in controlled environments, such as in human challenges studies (CHIM) where participants are deliberately exposed to infectious agents in order to directly measure effects.”

Modelling in humans to judge the value of interventions is essential prior to late phase studies, as animal models may provide a poor prediction of efficacy in the field. Our CHIM unit has modelled this recently in two studies and provided solid evidence for candidate choices.”

Vaccines development is a long process, and for the safety of the population, no step should be avoided, and clinical trials remain one of the vital components to ensure vaccine safety and efficacy.

* https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6685099/

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Renée Hart

President and Chief Business Officer, LumaCyte

A new method for rapidly measuring viral infectivity can help speed up the development of vaccines and antiviral therapies and improve diagnostics —which are vitally important in a pandemic.

In normal times, the general public doesn’t give much thought to the speed of vaccine production. But, these are not normal times; the rapid spread of the coronavirus has seen to that. Suddenly, the public is very interested in how threats from emerging diseases might be countered, and asking why it can take such a long time to get a vaccine to market.

The answer to that question, says Dr. Sean Hart, CEO and Chief Scientific Officer of research and bioanalytics instrumentation company LumaCyte, is that the current methods of measuring viral infectivity — which are crucial to the vaccine development process and clinical diagnostics — are generally slow, labour intensive, subjective, and difficult to standardise. “Traditional assays are based upon antiquated technologies,” he says. “Take plaque assays, where cells grow on a monolayer in a petri dish, which is a time-consuming process that can take between 10 and 15 days. These types of assays are known as ‘gold standards’ but, actually, they’re old, rusty and need to be replaced.”

Quicker technology can speed up vaccine development

Now, however, a new technology is able to more rapidly and accurately measure viral infectivity. This technology, Laser Force Cytology (LFC), can be used throughout the vaccine development and manufacturing process which can help to speed up response during a pandemic. “LFC is a cell-based assay that rapidly measures viral infectivity based upon the cells biophysical and biochemical response to the virus ,” says Dr. Hart. “It’s not the answer to every aspect of getting a vaccine to market; but it can dramatically compress the timeline and expedite the development of a vaccine, from R&D and process optimisation, to process monitoring, through formulations, release assays, to fill and finish.”

We have to take pandemics seriously and we need to be doing things to be ready for them.

An effective diagnostic tool to screen patients

Another big benefit of faster and more accurate analytical technology is that it can provide significant efficiencies for biopharma companies by catching mistakes in the biomanufacturing process early. “A rapid process analytical tool can save millions of dollars in lost materials, resources and time,” says Renée Hart, President and Chief Business Officer of LumaCyte. “With near real-time analytics, processes can be optimized sooner and corrective action taken ensuring consistent vaccine quality. And this is incredibly important, particularly if a vaccine needs to be produced quickly.”

Plus, in the area of clinical diagnostics, the new technology has the potential to rapidly screen patients for actively infectious virus. By taking nasal or oral swabs, sputum, or lung aspirates, it is expected that a cell based measure of the infectious status of the patient could be made within minutes, thus transforming a clinician’s ability to determine the course of treatment — or the need to quarantine. “The idea of quarantine creates a pandemic mindset in people,” says Ms. Hart. “Quarantine is an incredibly disruptive and expensive proposition and if we know whether a person is infectious it would allow for a more targeted response. From a diagnostic standpoint, a cell based viral infectivity measurement could really help society get back to normal.”

No time to stick with the status quo

If there’s any positive that can come from the coronavirus, it’s the hope that it will serve as a warning to the medical community that there needs to be a change in the way that viral infectivity is measured and monitored.

“The coronavirus is a wake-up call,” says Dr. Hart. “Now, at present, while this pandemic is terrible and has brought countries to a standstill, the mortality rate from the virus and complications currently appears to be relatively low, even if higher than seasonal influenza. But, one can envision a much worse scenario: a virus with a high mortality rate such as Ebola, but with the infectivity of the coronavirus or worse yet, smallpox. So, we have to take pandemics seriously and we need to be doing things to be ready for them. The question is: in a time of crisis, are companies going to gravitate to new tools and methods, or stick with what they know? It will be curious to find out how they respond — but I hope we don’t remain complacent.”

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As we take stock of the year gone by, one word comes up repeatedly: measles.

From early 2019, measles outbreaks, resulting in death and suffering, swept through the Democratic Republic of Congo (DRC), Madagascar, the Philippines, Ukraine and Samoa. Measles claimed over 6,000[1] lives in DRC, most of whom were children.

UNICEF, along with partners from the Measles & Rubella Initiative (M&RI) and GAVI, the Vaccine Alliance, worked with governments to respond to these outbreaks.

The measles vaccine

After massive response efforts, these outbreaks have now slowed down, thanks largely to a safe, effective and inexpensive measles vaccines. 

Across the world, millions of lives have been saved due to this vaccine. Vaccination resulted in an 80% drop in measles deaths worldwide from 2000 to 2017[2]. 

By vaccinating children, we also protect families from catastrophic out-of-pocket treatment costs to treat diseases.

The benefit of vaccines

Vaccines save lives from many other diseases. Today, immunisation against deadly diseases prevents between 2 and 3 million deaths each year, most of them children.[3]

Vaccines also make good economic sense. When illnesses are prevented due to vaccines, we save money related to hospitalisation.

By vaccinating children, we also protect families from catastrophic out-of-pocket treatment costs to treat diseases.

In addition, we can ensure that children are studying at school rather than recovering from illnesses at home. 

People not being vaccinated

Yet despite the power of vaccines, millions of children miss out on them every year. Vaccination coverage has stagnated at 85% globally, resulting in many new outbreaks in 2019, ranging from measles to cholera.[4]

In 2018, an estimated 19 million children missed out on their first dose of the measles vaccine. This is something that the world can ill afford.

Children may miss out on vaccinations due to inadequate basic infrastructure, such as transport and health services or breakdown of primary care services due to conflicts and political upheaval.

Even when medical services are available, insecurity and violence can prevent children from accessing services.  For example, in the DRC, immunisation services have been hampered due to poor infrastructure, conflict and attacks on health centres.

Measles doesn’t discriminate

Measles outbreaks are not limited to low-income countries. Even middle-and high-income countries have been affected.

In these countries, complacency may play a role in children not being vaccinated, while in other countries, parents may be influenced by misinformation and mistrust in the health services. 

To save mothers and their children, the world will need to expand primary health care systems to reach all children in order to achieve the SDG’s by 2030.

[1] https://www.afro.who.int/news/deaths-democratic-republic-congo-measles-outbreak-top-6000 | [2] https://www.cdc.gov/mmwr/volumes/67/wr/mm6747a6.htm | [3] Source: https://www.who.int/news-room/fact-sheets/detail/immunization-coverage | [4] Source: https://www.who.int/immunization/newsroom/measles-data-2019/en/

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Vaccinations are responsible for the eradication of some of the most dreaded diseases in history – but how do scientists make sure each batch is safe?

Developing new vaccines to fight emerging diseases is critical for the survival of the human race – and making sure they are pure is a huge part of that.

That’s according to Dr Archie Lovatt, Scientific Operations Director for biosafety at SGS Vitrology, in Glasgow.

He said: “It’s vital that we have the ability to react fast to new pathogen threats, such as the coronavirus and pandemic influenza, because if something with serious consequences does develop, it could potentially impact a lot of lives.

“We take it for granted now that we no longer have a constant high level of diseases like polio, smallpox, diphtheria, tetanus  and that’s all down to vaccination. But developing them is only one part of the cycle – they also need to be analysed and tested.”

Viruses are much more difficult to detect than bacteria and fungi, because they come in so many different types, shapes and forms.

Safety critical testing

Vaccination works by introducing an inactivated or altered form of a disease-causing pathogen into the body, which stimulates the immune system to develop the relevant antibodies and cellular response.

But injecting pathogens into the body comes with risks if the product is not meticulously assessed and tested.

It’s a complex task that’s carried out at specialist facilities, such as those run by SGS Vitrology.

“First, we have to establish the identity of the product, to make sure it is what we think it is. That’s done using nucleic acid-based DNA sequencing technology,” explained Dr Lovatt.

“It’s important because you don’t want people to be injected with something other than the vaccine they have asked for.”

Purity testing is the next step, during which the product is screened for contaminants such as unwanted bacteria or fungi, using standard sterility assays, and viruses.

“Viruses are much more difficult to detect than bacteria and fungi, because they come in so many different types, shapes and forms,” said Dr Lovatt.

“You have to use a real broad range of detection tools including electron microscopy studies, cell infectivity and molecular biology methods PCR and DNA sequencing.”

All part of the process

Failing to ensure the purity of product can lead to a range of side effects, such as sepsis or viral infection, in the final recipients – not to mention undermine the whole development process.

“If the product purity is not consistent, it can bring all the clinical trial data into question. It means that you can’t be sure that the effect you have seen in a clinical trial, that it is protective and efficient, is because of the agent or a contaminant that is in the product.

“If we accept that vaccines are vitally important, we have to accept that testing them is too,” Dr Lovatt concluded.

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As COVID-19 continues to spread, the topic of a vaccine is repeatedly raised, although it is unlikely one will be available for at least a year. However, World Immunisation Week (24-30 April) gives us the opportunity to reflect on the remarkable impact vaccination has already had on global society.

Immunisation is one of the most cost-effective ways to prevent deadly disease and contribute to improving the health of children across the world.

This year, the UK is hosting the Global Vaccine Summit and will continue as the lead donor to Gavi, the Vaccine Alliance, which has helped save three million lives.

The role of vaccines

Vaccines are playing an increasing role in preventing cancer and other conditions, as well as fighting infectious diseases, as antibiotic resistance becomes a greater challenge.

While microbes appear to be developing resistance to antibiotics more quickly, most vaccines do not lose their efficacy.

This World Immunisation Week join us as we build the political will and support required to deliver vaccines to all, no matter where they live.

The need for comprehensive vaccination of all children

Vaccination has led to a dramatic reduction in serious infectious diseases that were once commonplace.

Smallpox was completely eradicated in 1977 through a global vaccination programme, and we are within touching distance of eradicating polio which, before the vaccine was introduced in 1956, caused up to 7,000 cases of paralytic polio and 750 deaths in the UK each year. The UK has already renewed its commitment to the Global Polio Eradication Initiative.

However, vaccine-derived cases will only be prevented by the intensive polio campaign becoming part of a more systematic approach: ensuring comprehensive vaccination of all children with the 11 key childhood vaccines recommended by the World Health Organization (WHO).

The importance of remaining above the WHO vaccination safe level

While there is a strong drive to improve vaccination rates for children in developing countries, uptake in the UK is dropping, with many vaccines falling below the 95% WHO safe level, particularly in England.

The outbreak of measles across Europe in 2019, which led to over 80,000 cases and more than 70 deaths, is testament to the importance of immunisation.

Measles has come to be seen as a trivial condition in the UK, despite causing almost 150,000 deaths worldwide last year.

The spurious campaign against the Measles, Mumps and Rubella (MMR) vaccine has left many young adults in the UK and Europe unvaccinated and led to significant, and indeed fatal, outbreaks in recent years.

However, a recent report by the Royal Society of Public Health has shown that complacency, lack of access, lack of awareness, and logistical challenges are greater contributors to these falling rates than ‘anti-vaccine’ campaigns.

The reduction in life-threatening or disabling illnesses because of immunisation has led to complacency about the need for its ongoing use.

This World Immunisation Week join us as we build the political will and support required to deliver vaccines to all, no matter where they live.

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The 2013-2016 Ebola virus (EBOV) epidemic caused international alarm due to its rapid and extensive spread, resulting in a significant death toll and social unrest in West Africa.

Public Health England (PHE) was involved early in the West African outbreak, establishing a laboratory to support the Médecins Sans Frontières treatment centre in Guéckédou, Guinea in March 2014.

As a member of the European Mobile Laboratory – a rapid response unit made up of a network of high containment labs – 25 PHE Porton Down scientists from multiple fields were deployed to front line diagnostic labs in Guinea, Sierra Leone and Liberia over the following 24 months.

Studying survivor immunity

The large number of cases and EU funding afforded the PHE team a unique opportunity to study the immune response of both survivors and known contacts of those infected with the virus in Guinea.

All our capabilities and resources are now being applied in the international effort to find a new vaccine against COVID-19.

This formed the most comprehensive study of EBOV survivor immunity to date, thanks to the high number of survivors involved, its three-year duration, and the analysis of both neutralising antibody and T-cell responses. The latter gives us valuable insight into how EBOV can still circulate in the bloodstream after recovery, as the virus is known to hide and then re-emerge in immune-privileged sites like the eyes and testes – the latter leading to the threat of sexual transmission.

Overcoming challenges to the study

While other studies on survivor immunology exist, only a handful look at T-cell response because of the difficulty performing assays in country and in keeping the cells viable long enough to get them out of the country; they require a -80°C setting with dry ice.

We accomplished this by employing some pragmatic approaches, such as using a WHO cooling system intended for vaccines to transport samples 600 kilometres from the remote village of Guéckédou to the capital, Conakry.

The legacy of the research

Although the full study is yet to be published, over the last three years we have been providing data to the European Medicines Agency, the US Food and Drug Administration and the WHO Vaccines Committee, to assist their regulatory review process in licensing Merck’s Ervebo vaccine and other candidates still to be licensed.

Good relationships require investment and consistent communication, and when we returned each year, we shared our latest analysis with the participating survivors.

Through the leadership network, also made up of survivors, we explained what their immune responses to the virus meant in terms of protection against re-infection and different strains of EBOV.

Looking ahead to coronavirus

Professor Miles Carroll, Head of Research at the National Infections Service, PHE, says, “The dedication of the Ebola Virus Disease (EVD) Survivors’ Association enabled us to carry out this analysis and collect data which has been critical to vaccine development.

“This undertaking required enormous teamwork from partners including the Guinean state, the UK Foreign and Commonwealth Office, and colleagues within PHE’s National Infection Service.”

“All our capabilities and resources are now being applied in the international effort to find a new vaccine against COVID-19.”

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