Value of Vaccines - Q2 2020

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Q2 / 2020

Value of Vaccines

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Laetitia Bigger Director Vaccines Policy, IFPMA Page 16

“Is it possible to protect all populations from certain diseases, while keeping health system expenses within a reasonable range?”

Aurélia Nguyen Managing Director, Gavi, The Vaccine Alliance “The importance of driving down vaccine costs” Page 2

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Keith Klugman Director, Pneumonia, Bill & Melinda Gates Foundation “Pneumonia: the preventable health crisis the world has neglected” Page 6

Thomas M. File, JR., M.D., MSC, FIDSA, President Infectious Disease Society of America “Vaccines are our best weapons against pandemics” Page 18

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Keeping vaccines as affordable as generic medicines: a matter of life and death

IN THIS ISSUE

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Fundamental differences in developing vaccines and medicines mean that second generation vaccines are never going be as cheap as generic drugs, but there are still ways to reduce their cost.

“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”

G

Dr Philippa Whitford, MP for Central Ayrshire and Chair, All Party Parliamentary Group On Vaccinations for All

Aurélia Nguyen Managing Director, Vaccines and Sustainability, Gavi, The Vaccine Alliance

10 “Lessons learned: what the Ebola outbreak has taught us” Professor Miles Carroll Head of Research at the National Infections Service, Public Health England

Developing a vaccine never gets cheaper So why can we have generic drugs but not vaccines? Manufacturers of generic drugs and medicines need to follow the same chemical recipe as the brand-name version, but they don’t necessarily need to test the generics on people to see whether they respond to them the same way.

A vaccine, however, is considered to be a new biological entity, and must be tested on people, which is costly and time-consuming. With vaccines, manufacturers may have to repeat trials for any innovation they want to make, adding to costs.

Along each step of production, hundreds of quality control steps are needed, raising costs and increasing timelines for production. All of this can send the cost of vaccine production soaring.

16 “By Vaccinating children, we also protect families from catastrophic out-of-pocket treatment costs to treat diseases” Robin Nandy UNICEF Chief of Immunization and Representative On The Leadership Team of The Measles & Rubella Initiative

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eneric medicines – budget versions of brand-name drugs – are often quite literally a lifesaver because they are affordable. Vaccines are just as critical, protecting against infectious diseases such measles and polio, yet we don’t have cheap generics for vaccines.

This is because the biological nature of vaccines means the processes of manufacture, licensing and regulation are vastly different to medicines, leading to high fixed costs in development.

Since a vaccine can be the difference between life and death for billions of people, pushing for change in the factors that keep vaccine prices high is crucial.

Making vaccines more affordable for all Since 2000, Gavi, the Vaccine Alliance, has been working to make vaccines accessible and affordable through innovative financing mechanisms such as committing to the purchase of a vaccine still in development, thereby reassuring the manufacturers that a market exists.

However, newer vaccines can be more complex – for example, pneumococcal conjugate vaccines, which protect against diseases like pneumonia – and this can make them more costly.

While funding programmes can lower the costs for poorer countries by subsidising the vaccines, ideally the cost to produce the vaccines would be lower in the first place.

How to drive down vaccine costs Uncertainties about vaccine demand can mean manufacturers increase prices to ensure they get a return on their investment sooner rather than later. Introducing greater certainty of demand can therefore lower costs.

Investing in ways of improving biological standards and assays to speed up investigation or proof-of-concept could lower costs too, as could new platform technologies to accelerate R&D and better regulatory science for faster approvals. These shifts along the value chain of vaccine production would ultimately help lead to cheaper vaccines for those who need them most.

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This article is sponsored by SANOFI.

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

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Collaboration & Community: Confronting Vaccine-Preventable Diseases 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.

I

t 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.

To find out more about our work, please visit: www.sanofi.co.uk

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 preclinical 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 vaccinepreventable 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,

By HUGO FRY Managing Director of Sanofi UK

The goal of developing a vaccine will be achieved through collective efforts 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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

This article was commissioned and written by Sanofi UK Document Number: MAT-UK-2000379 Date of Preparation: April 2020 *All figures correct at time of publication

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Going hiking or camping in Europe? Are you aware of tick-borne encephalitis?

Tick-borne encephalitis (TBE) is a vaccine preventable disease found in parts of northern, central and eastern Europe and Asia. Many UK travellers are unaware of this disease.

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BE is a viral infection usually transmitted by the bite of an infected Ixodes tick. Less commonly, the disease can also be transmitted by consuming infected, unpasteurised dairy products. The number of human cases in Europe has increased by almost 400% in the last 30 years.1 In 2018, 3,212 cases were reported in EU/EEA countries.2 In Europe most cases are reported between May and November with a seasonal peak in July and August.2 Initial symptoms can include fatigue, headache and fever.

About one third of those with symptoms go on to develop more severe disease with signs of central nervous system involvement, such as meningitis or encephalitis.3 Unfortunately, there is no specific treatment. In Europe, up to 10% of those with TBE experience severe neurological complications and 0.5-2% will die.1 How to prevent TBE Ticks are often found on ground level vegetation, where they can easily be brushed onto a passing human. Ixodes ticks can be very small and difficult to see. Travellers can use insect repellents and clothing treated with insecticides to try and reduce bites.

Ticks can spread a number of different infections so any found on

LYNDA BRAMHAM Specialist Nurse (Travel Health), National Travel Health Network and Centre (NaTHNaC)

the skin should be carefully removed with fine tipped In Europe, up to 10% of those with tweezers or other devices TBE experience severe neurological for tick removal (available complications and 0.5-2% will die.1 in camping/walking shops or online). They should be pulled straight out with care given two weeks after the first. to avoid squeezing the body of the The manufacturers state the tick. It is sensible to avoid drinking protection rate is at least as high unpasteurised milk or eating other after the first two vaccinations unpasteurised dairy products following the rapid vaccination in TBE risk areas. i.e., before completion of the third dose.5 The third vaccination would TBE vaccination is recommended be recommended on return for for some travellers those requiring on-going, longerTBE vaccination is recommended term protection. particularly for spring, summer References: and autumn travel in areas where 1. European Centre for Disease prevention the virus is known or presumed and Control (ECDC)., Tick-borne encephalitis to occur in. factsheet for health professionals, 2015 https:// www.ecdc.europa.eu/en/publications-data/ Individuals who hike, camp, factsheet-tick-borne-encephalitis-healthhunt or undertake fieldwork care-professionals in risk areas should be offered 2. ECDC, Tick-borne encephalitis, annual epidemiological report for 2018, https://www. vaccination.4 The vaccine is also ecdc.europa.eu/sites/default/files/documents/ recommended for those who will TBE-annual-epidemiological-report-2018.pdf be going to live in risk areas, and 3. World Health Organization. Tick-borne particularly for those working in encephalitis vaccines position paper. July 2011 https://www.who.int/immunization/policy/posiforestry, woodcutting, farming and 4 tion_papers/tick-borne-encephalitis/en/ the military.

4. Public Health England. Chapter 31 Tick-Borne The vaccine available in the encephalitis, April 2013, in Immunisation UK is suitable for travellers from against infectious disease. https://www.gov.uk/ government/publications/tick-borne-encephalione year of age. The standard tis-the-green-book-chapter-31 vaccination course consists of 5. Pfizer Limited. Ticovac Summary of Product three doses, with the first two Characteristics, 6 November 2018 https://www. administered one to three months medicines.org.uk/emc/product/1923/smpc apart and the third dose five to 12 months after the second vaccine.

Travellers can check if TBE is a risk at their However, when rapid protection is destination on TravelHealthPro: required, the second dose can be travelhealthpro.org.uk/countries

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A spotlight on monkeypox Within one week in 2018, the UK had two unrelated cases of monkeypox in individuals returning from Nigeria. There was also transmission to a third person – a healthcare worker – the first occurrence of person-to-person transmission recorded outside of Africa.

M Dr Jake Dunning Head of Emerging Infections and Zoonoses, Public Health England

onkeypox is a rare viral infection, from the same family of viruses as smallpox. The first human case was recorded in 1970 in the Democratic Republic of the Congo (DRC). Since then, the infection has been reported in many central and west African countries, with most cases from remote parts of the DRC and Nigeria.

In 2003, an outbreak was recorded in the USA following importation of rodents from Africa.

All the human infections followed contact with an infected pet.

Fortunately, all patients recovered.

An outbreak anywhere in the world can have far-reaching implications for the UK, even if we have had very few cases. While it can be difficult to predict what is going to emerge as the latest threat, Public Health England has robust epidemic intelligence systems for detecting and assessing the risk to the UK from infectious diseases either at home or abroad.

The vaccine First-generation smallpox vaccines were initially produced in the late fifties, during the global smallpox eradication programme. Secondgeneration vaccines differed from the first as they were made using animal cells.

To reduce the complications experienced with the first- and second-generation vaccines, a third generation of attenuated vaccines were developed at the end of the global smallpox eradication programme. Attenuated vaccines use a weakened form of a virus, to provoke as strong and long-lasting an immune response as possible. It

cannot, however, spread or cause smallpox or monkeypox infection.

As part of the UK public health response, contacts of confirmed monkeypox cases were given a pre-exposure prophylaxis for specialist healthcare workers. In the UK, this is the first time that a third-generation smallpox vaccine has been used as a public-health response intervention during a monkeypox outbreak.

The study Studying this outbreak provides the unique opportunity to quantify and characterise antibody responses to the third-generation vaccine. So far, studies assessing immunised responses to monkey pox happen in the lab, whereas this is the first, real-world population study.

In addition, the study intends to demonstrate that vaccine-induced antibodies neutralise the specific monkeypox viruses involved in the UK outbreak.

All participants are healthcare workers who received the vaccine, or pre-exposure or post-exposure prophylaxis, during the 2018 cluster of cases. As of 12 October 2018, at least 59 healthcare workers have received post-exposure vaccine and at least 57 healthcare workers have received pre-exposure vaccine.

“Our study will provide additional scientific evidence to support the public health response of offering the vaccine during the recent UK monkeypox outbreaks.

“I hope that the results of our study provide reassurance to other countries that are considering adopting the vaccine for outbreakassociated vaccination.”

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The power of community immunity Unlike typical medicines, vaccines have the incredible superpower of protecting whole communities rather than just the individual.

This is vital for protecting vulnerable people in our communities, such as cancer patients.

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e are acutely aware of the devastating impact cancer can have on a person and their family.

But we often fail to relay that some cancer treatments can severely weaken the immune system. While many of us are forthcoming with fundraising and support campaigns for cancer patients, we must also remember to donate the invaluable power of community immunity.

Community immunity (or ‘herd immunity’) is achieved when enough people in the community are vaccinated against a disease, rendering it unable to spread. For example, measles requires 95% of people to be vaccinated to ensure that it cannot spread if introduced to the community.

In the UK, we are close to this for the first dose of the measles, mumps and rubella (MMR) vaccine, but, for the second dose, we have only reached a level of 86.4% (2018-19).

Now, the vulnerable people in our communities are at risk.Accounting for approximately three people in every 100 among us, this includes those undergoing cancer treatment, those with autoimmune diseases such as Crohn’s, ulcerative colitis or rheumatoid arthritis, and those living with organ transplants or HIV. These people are already struggling with life-long conditions, and now they are also at risk of contracting measles and other infectious diseases. Worse still, these individuals are more likely to develop complications, need hospital care, and are more likely to die from infections.

Pneumonia: the preventable health crisis the world has neglected Every year, 800,000 children die of pneumonia, a well-known but often-neglected disease. Though effective treatment and preventive vaccines exist, pneumonia remains the leading infectious cause of death for children.

D Dr Tonia Thomas Vaccine Knowledge Project Manager, Oxford Vaccine Group

As well as protecting this 3% of people, vaccines protect those who are temporarily vulnerable to infections, like babies who are too young to be vaccinated, pregnant women, and the elderly.

The societal benefits of choosing to vaccinate As a society we must realise that those of us who are healthy have the privilege of choosing whether or not to be vaccinated, but at a cost to those around us. By choosing not to protect ourselves and our comwmunities, we are endangering the lives of those who are not fortunate enough to have this choice.

Sources: 1: Babady, N. (2016). Laboratory Diagnosis of Infections in Cancer Patients: Challenges and Opportunities.

Journal of Clinical Microbiology, 54(11), pp.2635-2646. 2: Files.digital.nhs.uk.

(2019). Childhood Vaccination Coverage Statistics England, 2018-19. [online] Available at: https://files.digital.nhs. uk/4C/09214C/child-vacc-stat-eng-201819-report.pdf [Accessed 9 Feb. 2020]. 3: Varghese, L., Curran, D., Bunge, E., Vroling, H., van Kessel, F., Guignard, A., Casabona, G. and Olivieri, A. (2017). Contraindication of live vaccines in immunocompromised patients: an estimate of the number of affected people in the USA and the UK. Public Health, 142, pp.46-49.

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espite the high death toll, bacterial pneumonia – which is particularly serious for kids – only receives about 2% of global funding for neglected disease research and development.1 Access to diagnostic tools and treatments like X-rays, antibiotics, or oxygen also remains a challenge, particularly in low-income countries where most pneumonia deaths occur. The best option for children in these areas is to prevent them from getting sick in the first place by giving them the vaccines they need.

Pneumococcal conjugate vaccines have had major success in highincome countries One particularly important tool in the fight against pneumonia are pneumococcal conjugate vaccines (PCV), which have reduced rates of severe pneumonia by more than half in the high-income countries that have used them for nearly two decades. But, while this important tool exists, many communities in low- and middle-income countries still don’t have access to the vaccines, leaving millions of children without protection against this deadly disease.

Thankfully, a new vaccine will soon be on the market that will help reduce this disparity and make PCVs available to more children.

The availability of this vaccine will help alleviate one of the biggest barriers to sustainable access to PCVs that countries face – price.

A new pneumococcal vaccine from the Serum Institute of India was recently approved for use by the World Health Organization and is expected to be 30% cheaper for low-income countries than existing vaccines.

Lower-priced vaccines With the support of organisations like Gavi, the Vaccine Alliance, poor countries will be better placed than ever before to introduce these vaccines into their routine immunisation programmes. Gavi helps increase access to vaccines in low-income countries and has already supported 59 low-income countries to introduce PCVs, reaching more than 183 million children.

Keith Klugman Director, Pneumonia, Bill & Melinda Gates Foundation

Thankfully, a new vaccine will soon be on the market that will help reduce this disparity and make PCVs available to more children.

With the availability of a more affordable vaccine, countries will have more options to choose from.

The lower price means they can free up valuable resources for other health or development priorities.

There are encouraging signs of progress. Indonesia announced in January that it would make PCV part of its routine immunisation programme and committed to vaccinating four million children each year. Rolling PCVs out in a country like Indonesia, with a large population and a high burden of pneumonia, is a major step forward.

Pneumonia prevention must be a priority Reducing deaths from pneumonia in the long-term will require putting pneumonia at the top of the global agenda and keeping it there.

High-burden countries must make protecting children from pneumonia through well-functioning primary healthcare systems a top priority.

Donor governments must continue to generously fund organisations like Gavi to ensure countries have the support they need to introduce PCVs and sustain their use in every community.

To create a world free of preventable disease, we must ensure every child can access these life-saving vaccines – no matter where they live.

References: 1. Policy Cures Research. G-FINDER 2019: Neglected Disease Research and Development: Uneven Progress, Jan 2020. https://s3-ap-southeast-2.amazonaws. com/policy-cures-website-assets/app/ uploads/2020/01/30100951/G-Finder2019-report.pdf

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“Vaccines have become a victim of their own success” A sense of complacency could be contributing to a decline in vaccine uptake rates.1 Read how increased public awareness and improved access to health services could be key in reversing the trend.

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he trouble with vaccines,” says Philip Cruz, UK Vaccines Medical Director at GSK, “is that they have become a victim of their own success. It’s only when health is in the news after a virus outbreak or the release of new data, that we are reminded of the crucial role vaccines play in safeguarding our health.”

“Vaccination has prevented millions of illnesses2 and, in terms of worldwide public health interventions, only clean drinking water is more effective in its ability to save lives.”3 Vaccination throughout life We tend to associate immunisation largely with babies and children, but that mindset has to change, says Cruz. “As we age, our immune system does too, and this can make us more vulnerable to lifethreatening diseases.”

“Ensuring we are fully vaccinated as adults can help protect us and those closest to us against some serious diseases.4 This is particularly important for vulnerable groups, such as those with chronic illnesses who are not able to receive vaccination due to weakened immune systems.”

people are a small minority and not the Philip Cruz main issue, says UK Vaccines Medical Cruz. Instead, Director, GSK the decline in vaccination rates is a multi-factorial challenge.

These challenges range from practical issues, such as timing, location and availability of appointments to complacency, with some believing elimination of certain diseases means they no longer need to receive the vaccine.6 Investment to tackle a system-wide challenge More must be done to address the general lack of education about vaccination. This includes ensuring there is accurate, easily accessible information online. This is where concerned people are likely to look if they can’t get answers from their time-strapped clinical practice.

Falling uptake figures include people who received the first dose of a vaccination but didn’t return for their second or third dose. It has to be made clear to patients that they must receive a full vaccination course to experience the full benefit.

“It sounds simple, but staff at a clinic, such as receptionists, can play a crucial role,” says Cruz. “They’re the ones talking to patients and scheduling appointments.”

Ensuring optimal access to appropriate services is a systemwide challenge. Therefore, Cruz welcomes the recent news that there will be an additional investment of £30 million in UK primary care vaccination and immunisation services.

“There has to be clear and precise guidelines for the delivery of vaccines, and more accountability across the system. This can be helped by practices having a main vaccination lead,” he says.

“Increasing accessibility could include providing interpreters and translations for communities with non-English speaking parents and

Only clean drinking water is more effective than vaccination in its ability to save lives.

The factors behind declining vaccination rates Worryingly, vaccination rates have been dropping in recent years. One example is MMR (measles, mumps and rubella) immunisation.

To ensure ‘herd’ or ‘community’ immunity, and to prevent measles outbreaks, the MMR vaccine must achieve a coverage level of 95%. But, in 2019, MMR coverage levels fell to around 87%, and the UK lost its measles-free status.5 “Measles is a very infectious disease, so losing our status is a cause of concern for parents, policymakers and healthcare professionals,” says Cruz.

Some news stories have pinned the blame for falling vaccination rates on ‘vaccine refusers.’ But despite what you might read, these

creating pop-up clinics out of hours for parents and others who can’t get time off work. Although all of this can be quite a logistical challenge.”

Working together to spread awareness Industry can help, too: by spreading the word with vaccination awareness campaigns, while working in partnership with public health authorities and patient groups to find out where the pain points are.

“We’re currently studying communities with low MMR coverage and working with local health authorities on how best to advise parents and the public about vaccinations,” says Cruz.

GSK is also currently supporting the development of a coronavirus vaccine.7 This is a team effort, stresses Cruz — as is the work to ensure that uptake rates for available vaccinations will start to increase across the board.

“I’m optimistic that vaccination rates will rise again,” Cruz says.

“Although, in terms of increasing public awareness about their importance, we’re just getting to base camp. The summit is still some way off.”

References: 1. United Nations, 2019. ‘Complacency’ a factor in stagnating global vaccination rates, warn UN health chiefs. Accessed online: Mar 2020.

2. Walter A. Orenstein & Rafi Ahmed, 2017.

Simply put; vaccination saves lives.

3. Plotkin SL & Plotkin SA, 2012. A short history of vaccination.

4. Vaccines.gov, 2017. 1-4: Adults Age 65 and Older.

5. Public Health England, 2019. Measles in England. Accessed online: Mar 2020.

6. Royal Society for Public Health, 2018.

Moving the needle.

7. GSK, 2020: Our contribution to the fight against novel coronavirus (COVID-19).

Accessed online: Mar 2020.

This article is sponsored by GSK.

CL code: NP-GB-ABX-JRNA-200001. Date of preparation: March 2020 Read more about vaccination through life at the GSK website: vaccinateforlife.com

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This article is sponsored by ARTEL.

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.

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he 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 are guidances 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.”

Dr Nathaniel Hentz Director, Scientific Market Development, Artel

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.”

Artel works with labs helping them achieve assay development, liquid handling performance and operator training goals. For more information, please visit: artel.co

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How to ensure quality in vaccine development

The importance of vaccines for all As COVID-19 continues to spread, the topic of a vaccine is repeatedly raised, althoughit is unlikely one will be available for at least a year.

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owever, 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.

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

Dr Philippa Whitford MP for Central Ayrshire and Chair, All Party Parliamentary Group on Vaccinations for All

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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This article is sponsored by British Society for Immunology.

Why the insect cell system is a boost for vaccine development

Celebrating the UK’s role in vaccine development The UK is leading the way in the development and research of vaccines. Investment is vital to ensure new vaccinations are developed and that they reach those who need them most.

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hen it comes to vaccine innovation, the UK has much to be proud of – from Edward Jenner’s discovery of a smallpox vaccine back in the eighteenth century, right through to current research around coronaviruses.

In fact, the UK tops the list of G7 nations in terms of the impact of its immunology research in advancing diagnosis, prevention, treatment, and cures.

However, Dr Doug Brown, Chief Executive of the British Society for Immunology (BSI), is quick to point out that the UK’s achievement is no stroke of luck. “This has come from investment in research,” he says.

“We need to make sure we have the right level of funding, the right policies in place to do the research and then to establish the infrastructure to deliver vaccines in the community.”

Dr Doug Brown Chief Executive, British Society for Immunology

impact on global public health after the provision of clean water.

To help shine a light on their significance, the BSI have put aside 26 March to celebrate vaccines and the role they play in improving global public health.

“We need to remind the public, remind government that there are diseases that have almost disappeared, and that’s only because of effective vaccination programmes,” says Brown.

We’re already in the final stages of eliminating polio, and, with continued investment, Brown believes measles and rubella could also be consigned to the history books.

“We’re also looking at the big health issues like HIV and malaria,” says Brown. “There are a couple of trials out in the field, with the first malaria vaccine now being introduced.

We’re hopeful that, with a global effort, there could be some exciting developments in the years to come.”

While there is understandably a focus on known diseases, the benefits of immunology research stretch much further. As we’ve seen with coronavirus, new pathogens emerge all the time, and investment in research will ensure we’re prepared.

The World Health Organization estimates that between 2010 and 2015 immunisations helped to save the lives of more than 10 million people.

Vaccines saved 10 million lives in five years The stakes are certainly high.

The World Health Organization estimates that between 2010 and 2015 immunisations helped to save the lives of more than 10 million people. This is a staggering number, but the wave of success has been followed by a period of complacency in some parts of the world.

In the UK, the number of infants receiving the MMR vaccination has fallen for the fifth consecutive year. “In many ways, vaccinations have become a victim of their own success,” continues Brown. “For a generation we’ve not seen some of these diseases, so we can be forgiven for forgetting just how serious they are.”

Celebrating what vaccines have done for us Vaccines have the second biggest

Written by: Kate Sharma

Read more at immunology.org/celebratevaccines

To combat emerging diseases, it’s crucial that vaccines and diagnostic assays can be made available quickly and cost-effectively. One protein expression platform does just that.

T

he World Health Organization (WHO) has a list of emerging diseases,” says Linda King, Professor of Virology at Oxford Brookes University and founder of Oxford Expression Technologies, which provides products, services and consultancy to the global pharma and biotech industries.

“Most people won’t have heard of the diseases on this list — at least not until one of them spreads and sparks a crisis like Covid-19. Then they realise there isn’t a vaccine for it.”

Leading research and development technology to enable faster results That worryingly familiar scenario is why one area of interest for King’s company is vaccine and companion diagnostic development.

It’s currently lead partner in a consortium to develop a vaccine and companion diagnostic for an emerging disease called Crimean-Congo Haemorrhagic Fever (CCHF), which spreads to humans by tick bites or through contact with the contaminated blood of an infected, slaughtered animal.

The World Health Organization notes that CCHF is difficult to prevent and treat, and that it has a high case fatality ratio (10%-40%).

To develop vaccines, researchers are using a Baculovirus-based protein expression platform. This enables high through-put production of multiple candidate vaccines or proteins (antigens) for use in diagnostic assays, and works using insect cells, rather than conventional mammalian cells. The expression platform can also be used to make proteins for other areas of health-related R&D, such as basic science and drug discovery.

“The insect cell system for vaccine development has become a popular platform,” says Professor King.

“Mammalian cells require very specific laboratory conditions, which insect cells do not. Insect cells are also much cheaper to culture than mammalian cells, and they are deemed to be very safe. Plus, insect cells can be scaled up quickly and effectively.”

Using this technology, OET scientists have started work to produce the Covid-19 spike glycoprotein in insect cells as part of its contribution to urgent global efforts to develop a vaccine.

Vital that vaccines are quickly available in any outbreak In an outbreak situation, the Baculovirus-platform ensures that an approved-for-use diagnostic test to screen people, and a cost-effective vaccine to protect them, can be made quickly.”

King recognises that big pharma companies aren’t often interested in getting involved in vaccine development for the relatively small emerging diseases market.

“But I think the lack of a vaccine during the last Ebola outbreak, and in the current Covid-19 pandemic, has made governments realise that this is an important area to invest in,” she says. “When an outbreak does occur, it’s absolutely vital that vaccines and diagnostics can be made available quickly and cost-effectively.”

Linda King Professor of Virology, Oxford Brookes University and Founder, Oxford Expression Technologies

Written by: Tony Greenway

This article is sponsored by Oxford Expression Technologies

Read more at oetltd.com

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Professor Miles Carroll PHE, joined by Dr Ana Maria Henao-Restrepo of the WHO and Guinean state dignitaries, receive the Ebola vaccination (PHE March 2015)

Lessons learned: what the Ebola outbreak has taught us From 2013 to 2016, the Ebola virus (EBOV) spread across West Africa, killing over 11,000 people and affecting around 30,000.

P Professor Miles Carroll Head of Research at the National Infections Service, Public Health England

ublic 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.

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 The large number of cases year, we shared and EU funding afforded our latest the PHE team a unique analysis with the participating opportunity to study the survivors. immune response 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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Inside the world of vaccine testing – and why it matters 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?

Dr Archie Lovatt Scientific Operations Director for Biosafety, SGS Vitrology

D

eveloping 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.”

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.

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.

“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,

“More ‘real-world’ efficacy studies are needed” Adrian Wildfire Scientific Director, SGS Life Sciences

D

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

iscussing 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 our vaccine 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 alltime 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

These articles are sponsored by SGS.

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.

Written by: Amanda Barrell

infected, do they remain well?

There are two ways of measuring vaccine success: 1. Does the patient get better?

2. 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 climb 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

Read more at www.sgs.com/ Lifesciences

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/

Written by: James Alder

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© T H O M AS N Y B O

The simple solution for saving lives: invest in vaccines

Lucie Kavira holds her infant daughter, Judith, and readies her to receive a number of vaccines at a UNICEF-sponsored immunisation clinic in the village of Kuka on the outskirts of Beni in North Kivu province, Democratic Republic of the Congo on 21 October 2019 “It’s important for me to protect my child,” Lucie says. “I don’t want her to get sick.”

UNICEF provides the vaccines, cold storage, transport, and logistical and technical support so that health workers can administer the vaccines.

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

F Professor Miles Carroll Robin Nandy Chief of Immunization and Representative On The Leadership Team Of The Measles & Rubella Initiative, UNICEF

rom 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 6,0001 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 The benefit of vaccines Vaccines save lives from many other diseases. Today, immunisation against deadly diseases prevents between two and three 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.

References: 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/factsheets/detail/immunization-coverage 4: https://www.who.int/immunization/newsroom/ measles-data-2019/en/

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Measles vaccination campaign in Mahajanga II EU ECHO supported UNICEF to vaccine more than 1.2 million children during this third campaign against the measles outbreak.Marimar and Jenila are getting ready to get vaccinated.

Communication is key to eradicate polio

F

Vaccination – one of the greatest and most cost-effective global health achievements – saves five lives every minute. It has led to the global elimination of smallpox, reduced global child mortality rates, and prevented countless lifelong disabilities such as paralysis from polio.

rom 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 lives in DRC, most of whom were children.

So, why are we seeing more and more outbreaks of viral diseases, despite widespread vaccination programmes?

Take measles, for example.

In the US, vaccination led to the total eradication of measles by 2000. Yet in 2019, 1,282 cases were confirmed in 31 states; the highest number since 1992. It’s a similar story elsewhere. In the UK, measles cases are now higher than in the 1990s. Globally in 2019, over 400,000 confirmed cases of measles were reported to the World Health Organization (WHO) in 187 countries.

Part of the answer lies in the erroneous and often dangerous ideas about vaccination that circulate so much faster in our connected, social media world.

In addition, there are generations that no longer know what infectious

diseases are and what they can cause. To combat these false narratives, and make clear what vaccines can prevent, there is an urgent need for accurate, clear and concise communication of the scientific aspects and societal advantages of vaccination.

With this objective in mind, in 2019 the One Health Platform initiated VAXVOX, a scientific reference point on vaccinationrelated issues. It aims to spread scientific core messages and thereby raise a solid, united voice in the debate about vaccination.

Affirming the urgency for further vaccination against polio One focus areas is polio, an infectious viral disease that targets mostly children under the age of five. One in 200 infections leads to paralysis, which can be of the limbs or, more seriously, of the respiratory muscles which can result in death.

In the early 20th century, polio was one of the most feared diseases in industrialised countries, paralysing hundreds of thousands of children every year. The tide turned in the 1950s when two polio vaccines were developed, by Jonas Salk (1955) and Albert Sabin (1961).

Polio was brought under control and was practically eliminated as a public health problem in the industrialised world. However, it still remained a major health problem in developing countries, where 350,000 children were contracting polio annually. This led to the WHO launching its Global Polio Eradication Initiative in 1988.

The hugely successful initiative has led to nearly 3 billion children being immunised against polio in the last 30 years. It is estimated that around 18 million people are able to walk today who would otherwise have been paralysed. An estimated 1.5 million children would otherwise have died as a consequence of catching polio. In four of the WHO regions, polio has been officially declared eliminated: the Americas (1994), Western Pacific (2000), Europe (2002) and most recently South-East Asia (2014).

The final, knock-out blow to polio and a new vaccine However, until the polio virus is totally eradicated, there remains a risk of a major outbreak that could result in as many as 200,000 new cases each year over the whole world.

Pierre Van Damme Professor in Vaccinology, University of Antwerp, Belgium

Unfortunately, stamping out the last strongholds of the polio virus – mainly in Afghanistan and Pakistan – is proving extremely challenging. These last polioaffected regions are often plagued by political instability and conflict, mass population movement, poor healthcare infrastructures, and the inaccessibility of some remote areas. Combined, these make it very difficult for healthcare workers to reach and vaccinate the populations at risk.

To secure a future free of polio, the WHO has launched its Polio Endgame Strategy 2019-2023. It’s a multi-strategy approach that includes the accelerated development of a new, genetically engineered vaccine. Its deployment could happen as early as June 2020 under the WHO’s emergency protocols.

VAXVOX is fully behind the WHO strategy and we will do all we can to communicate the key scientific messages underlying the use of vaccination to help ensure a world where no child contracts polio ever again.

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Beyond childhood: the case for life-course immunisation Is it possible to protect all populations from certain diseases, while keeping health system expenses within a reasonable range? Let’s look at implementing a life-course approach to immunisation…

T

How can LCI benefit communities as a whole?

Improving immunisation rates in the community has the potential to protect vaccinated individuals and vulnerable populations, like children and immunocompromised

© TO M WA N G 1 1 2

he global population continues to age.

In 2020, children under five years will be outnumbered by people of 60 or more 1 years. This means prevention of disease is becoming more important. A life-course approach to immunisation (LCI) promotes Laetitia Bigger individual and population health, Director, Vaccines Policy, and emphasises the prevention of International disease. So, what exactly is a lifeFederation of course approach to immunisation?

Pharmaceutical ‘The life-course approach to Manufacturers and Associations (IFPMA) immunisation recognises the role of immunisation as a strategy to prevent disease and maximise health over one’s entire life, regardless of an individual’s age and includes all populations.’2 Worldwide, vaccines save between two and three million lives each year.3 Immunisation is considered one of the most effective public health achievements of modern society. However, until recently, the target has only concerned under Worldwide, vaccines save children five years of between two and three age, and little focus has been million lives each year.3 beyond Immunisation is considered given infancy. As one of the most effective research shown, public health achievements has pregnant of modern society. women, adolescents, older adults, people with certain chronic conditions, caregivers, healthcare professionals, and vulnerable and marginalised communities, face an increased risk of contracting vaccine-preventable diseases and can greatly benefit from an LCI approach.4 While this is recognised at global level, progress within individual countries has been slow.

individuals, who are at high risk of infections. Investing in an LCI approach on a health system level can support universal health coverage by reaching people who may not have access to primary healthcare services by providing infrastructure. An important feature and benefit of LCI is the indirect impact of some vaccines on antimicrobial resistance (AMR).

Increased uptake of AMR-related vaccines throughout the life course, as a complementary tool to mitigate the threat of AMR, is essential due to antibiotics becoming gradually less effective against resistant bacteria.

It is critical to increase the uptake and coverage of existing vaccines, to prevent disease and reduce demand for antibiotics, safeguarding their effectiveness.

ultimately an increased GDP. Therefore, LCI reduces the burden on healthcare services, promotes healthy ageing and addresses health risks like infectious diseases and AMR, which impact the global economy. LCI is thus recognised a cost-effective intervention.8 Harnessing the benefit of LCI will require policy changes and innovative approaches.

A report from The Health Policy Partnership supported by IFPMA9 showcases important lessons from six countries who are in different stages of implementing LCI. It identifies five key policy areas which, if accomplished, would lead to building healthier communities and nations with a strong vaccination foundation – a foundation of primary healthcare.

Creating a healthy and prosperous society The World Health Organization (WHO) estimates the global yearly return on investments to vaccination is 12-18%6. For every €1 invested, the government gets back €4.02 of economic revenue.

A greater vaccine uptake contributes to a positive impact on education, workforce productivity, and

References: 1: (World Health Organization), 2: (IFPMA; Health Policy Partnership, 2019), 3: (Delany, Rappuoli, & Gregorio, 2014), 4: (IFPMA; Health Policy Partnership, 2019, p. 12), 5: Ibid p 4, 6, 9, 6: (Andre, et al., 2008), 7: (Supporting Active Ageing Through Immunisation (SAATI) Partnership, 2013), 8: (IFPMA; Health Policy Partnership, 2019, p. 13), 9: (IFPMA; Health Policy Partnership, 2019)

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Failures to overcome vaccine hesitancy, inspired by misinformation campaigns, as well as obstacles to routine healthcare access has enabled the spread of preventable disease.

© MANJURUL

Vaccines are our best weapons against pandemics From measles to the next unknown pandemic, medical immunisations remain an essential component to the sustainable control of infectious diseases. First, however, they must be available and accepted.

Thomas M. File, Jr., M.D., MSc, FIDSA President, Infectious Diseases Society of America

T

he vaccine development era of last century ushered in the ambitious global public health era of this century.

This led to the eradication of smallpox and the near eradication of polio. It enabled the elimination of measles in countries across the globe, and greatly reduced the global impacts of deadly infections such as pertussis and childhood meningitis. Even as violence and political instability have undermined efforts to gain control of the ongoing Democratic Republic of Congo Ebola outbreak, a newly developed vaccine has protected health workers, families and communities and averted even more damage.

With the inspiration of these examples, the nearly four-decade quest for a vaccine against HIV has continued. Other, proven prevention measures have also spurred strides toward ending the pandemic’s global impact.That’s because we know what vaccines can do. Every year, vaccines are estimated to prevent from two million to three million deaths globally. The accelerated rollout of measles vaccines between 2000 and 2017 alone led to an 80% worldwide drop in measles deaths. Still, the full value of this formidable weapon against preventable illnesses and deaths remains unrealised.

Misinformation and access barriers cost lives In spite of the proven value of vaccines, 1,200 measles infections were recorded last year in the United States – the highest number since 1992 – despite a declaration in 2000 that local transmission of the virus had been eliminated. Failures to overcome vaccine hesitancy, inspired by misinformation campaigns, as well as obstacles to routine healthcare access has enabled the spread of preventable disease. While the great majority of illnesses in the United States were among people who had not been vaccinated, that was only part of the story.

It is important to note the outbreaks all originated with travellers who imported the disease from countries where measles remains endemic – and where vaccine access is limited.

Due to obstacles, including long distances to clinics, health system supply gaps and health worker shortfalls, a 2019 WHO/CDC report found that global coverage with the first dose of measles vaccine stalled at 85%. This is significantly shy of the 95% necessary to prevent outbreaks.

Goals and resources can save lives A new global immunisation strategy by the World Health Organization (WHO), to accelerate and expand vaccine coverage,is important and timely.

An early draft of the strategy

calls for countries to develop improved methods and means to educate vaccine-hesitant families and communities – on vaccine safety and effectiveness.

In the US, the VACCINES Act, under consideration by Congress, would support those efforts on the domestic front, and also strengthen surveillance and responses to outbreaks of vaccine-preventable diseases. The WHO draft strategy also calls for supporting immunisation capacities during outbreaks, as well as other emergencies including conflicts.

WHO also should set global goals with deadlines for coverage of universally important vaccines, including those for measles, mumps and rubella (MMR) and for diphtheria, tetanus, and pertussis (DtaP). Those goals and deadlines can drive investment priorities, propel progress, and build accountability.

Infectious diseases don’t observe borders Implementing these strategies will require strengthened health systems in many countries lacking resources to provide the routine health care needed to detect, prevent and respond to health threats where they originate.

Continued and sustained US leadership and support of global health security partnerships will be crucial to accomplishing that goal overseas, and essential to protecting health at home.

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What are the critical access challenges for vaccines in the US? 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

Kelly Cappio Associate Principal, Avalere Health

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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 pneomoccocal 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 costsharing 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 program, 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

© N ATA L I _ M I S

Richard Hughes IV Managing Director, Avalere Health

’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 specializing 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.”

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 prelicensure under an Emergency Use Authorisation by the Food and Drug Administration (FDA).

“Typically, the ACIP doesn’t

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

Written by: Tony Greenway

This article is sponsored by AVALERE.

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