Value of Vaccines V1 - Q1 2020

Q1 / 2020 AN INDEPENDENT SUPPLEMENT FROM MEDIAPLANET WHO TAKE SOLE RESPONSIBILITY FOR ITS CONTENTS AURÉLIA NGUYEN, GAVI, THE VACCINE ALLIANCE “The importance of driving down vaccine costs” » p2

THOMAS M FILE, JR, MD, MSC, FIDSA, INFECTIOUS DISEASE SOCIETY OF AMERICA

“Vaccines are our best weapons against pandemics” » p8

PROFESSOR MILES CARROLL, PUBLIC HEALTH ENGLAND

“Lessons learned: what the Ebola outbreak has taught us” » p10

Value of Vaccines HEALTHAWARENESS.CO.UK

“Tick-borne encephalitis (TBE) vaccination is recommended for some travellers” Lynda Bramham, Specialist Nurse National Travel Health Network and Centre (NaTHNaC) p4 © GAVI/2019/ISAAC GRIBERG

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

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

KEITH KLUGMAN Director, Pneumonia, Bill & Melinda Gates Foundation

AURÉLIA NGUYEN Managing Director, Vaccines and Sustainability, Gavi, the Vaccine Alliance

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eneric medicines – budget versions of brand-name dr ugs – are of ten 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 fi xed costs in development.

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

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.

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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 Unc e r t a i nt ie s ab o ut v ac c i ne 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-ofconcept could lower costs too, as could new platform technologies to accelerate R& D a nd bet ter reg u l ator y s c ienc e for fa s ter 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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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 fi rst 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 t hat have u se d t hem for nea rly t wo 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.

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 t h r o u g h we l l - f u n c t i o n i n g p r i m a r y 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/GFinder-2019-report.pdf

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In rural Kenya, a mother stands outside hugging her daughter.

The new pneumococcal vaccines are highly complex and sophisticated vaccines that in the past might otherwise have taken 15 years or more to reach lowincome countries.

The most common cause of pneumonia – the world’s leading killer of children – is the pneumococcal bacterium, Streptococcus pneumonia. Thanks to the work of Gavi, its donors and partners, the world’s poorest children are now receiving the newest pneumococcal vaccines nearly simultaneously with children in developed countries.

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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 t ra n sm it ted by t he 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 I n it i a l s y mptom s c a n i nc lude 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

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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 the skin should be carefully removed with fine tipped tweezers or other devices for tick removal (available in camping/walking shops or online). They should be pulled straight out with care to avoid squeezing the body of the tick. It is sensible to avoid drinking unpasteurised milk or eating other unpasteurised dairy products in TBE risk areas.

TBE vaccination is recommended for some travellers T BE vaccination is recom mended particularly for spring, summer and autumn travel in areas where the virus is known or presumed to occur in.

Individuals who hike, camp, hunt or undertake fieldwork in risk areas should be offered vaccination. 4 The vaccine is also recommended for those who will be going to live in risk areas, and particularly for those working in forestry, woodcutting, farming and the military.4

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

In Europe, up to 10% of those with TBE experience severe neurological complications and 0.5-2% will die.1 The vaccine available in the UK is suitable for travellers from one year of age. The standard vaccination course consists of three doses, with the first two administered one to three months apart and the third dose five to 12 months after the second vaccine. However, when rapid protection is required, the second dose can be given two weeks after the first.

T h e m a nu f a c t u r e r s s t at e t h e protection rate is at least as high after the first two vaccinations following the rapid vaccination i.e., before completion of the third dose.5 The third vaccination would be recommended on return for those requiring on-going, longer-term protection.

Travellers can check if TBE is a risk at their destination on TravelHealthPro:

References: 1. European Centre for Disease prevention and Control (ECDC)., Tick-borne encephalitis factsheet for health professionals, 2015 https://www.ecdc.europa.eu/en/ publications-data/factsheet-tick-borne-encephalitishealthcare-professionals 2. ECDC, Tick-borne encephalitis, annual epidemiological report for 2018, https://www.ecdc. europa.eu/sites/default/files/documents/TBE-annualepidemiological-report-2018.pdf 3. World Health Organization. Tick-borne encephalitis vaccines position paper. July 2011 https://www.who. int/immunization/policy/position_papers/tick-borneencephalitis/en/ 4. Public Health England. Chapter 31 Tick-Borne encephalitis, April 2013, in Immunisation against infectious disease. https://www.gov.uk/government/ publications/tick-borne-encephalitis-the-green-bookchapter-31 5. Pfizer Limited. Ticovac Summary of Product Characteristics, 6 November 2018 https://www. medicines.org.uk/emc/product/1923/smpc

travelhealthpro.org.uk/countries.

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A spotlight on monkeypox

DR JAKE DUNNING Head of Emerging Infections and Zoonoses, Public Health England

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.

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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 F i r s t- g e n e r at i o n smallpox vaccines were initially produced in t he late fifties, during the global smallpox eradication programme.

S e c o n d generation vaccines differed from the first as

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they were made using animal cells.

To reduce t he compl icat ion s experienced with the first- and secondgeneration 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 re s p on s e, c ont ac t s of c on f i r me d monkeypox cases were given a preexposure 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 ch a r ac ter i s e a nt ib o dy re s p on s e s to the third-generation vaccine. So far, st udies assessing im mun ised responses to monkey pox happen in the lab, whereas this is the fi rst, realworld population study.

In addition, the study intends to

demonstrate that vaccine-induced antibodies neutralise the specific monkeypox viruses involved in the UK outbreak.

A l l par ticipants are healt hcare 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 preexposure vaccine.

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

“I hope t hat t he results of our study provide reassurance to other countries that are considering adopting the vaccine for outbreak-associated vaccination.”

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Beyond childhood: the case for The power of community life-course immunisation immunity Is it possible to protect all populations from certain 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.

DR TONIA THOMAS Vaccine Knowledge Project Manager, Oxford Vaccine Group

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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.

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 communities, 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-2018-19-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

diseases, while keeping health system expenses within a reasonable range? Let’s look at implementing a lifecourse approach to immunisation…

LAETITIA BIGGER Director, Vaccines Policy, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

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he global population continues to age.

In 2020, children under five years will be outnumbered by people of 60 or more years. 1 This means prevention of disease is becoming more important. A life-course approach to immunisation (LCI) promotes individual and population health, and emphasises the prevention of disease.

So, what exactly is a life-course approach to immunisation? ‘The life-course approach to 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 children under five years of age, and little focus has been given beyond infancy. As research has shown that pregnant 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.

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

How can LCI benefit communities as a whole?

Improv ing im mun isation rates in t he c om mu n it y h a s t he p otent i a l to protec t vacci nated i nd iv idua l s a nd vulnerable populations, like children and immunocompromised individuals, who are at high risk for 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.

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 (W HO) est imates t he globa l yearly ret ur n on investments to vaccination is 12-18% 6. For every €1 invested, the government gets back €4.02 of economic revenue.7 A greater vaccine uptake contributes to a positive impact on education, workforce productivity, and ultimately an increased GDP. Therefore, LCI reduces the burden on healthcare services, promotes healthy ageing and addresses health risks like infectious diseases and AMR that 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 IFPMA 9 showcases important

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)

www.escmid.org

The congress of

www.eccmid.org

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CONTENT COMMISSIONED BY GSK

“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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The 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.”

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 M MR vaccine must ach ieve a c over a ge level of 9 5% .

But, in 2019, M MR coverage levels fell to around 87%, and the UK lost MEDIAPLANET

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

These chal lenges range from prac t ica l issues, such as t i m i ng, location and availabilit y 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 systemwide 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 timestrapped 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 system-wide challenge. Therefore, Cruz welcomes

PHILIP CRUZ UK Vaccines Medical Director, GSK

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

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.”

the recent news that there will be an additional investment of £30million 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 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.”

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.

Working together to spread awareness Industry can help, too: by spreading the word with vaccination awareness ca mpa ig n s, wh i le work i ng i n p a r t n e r s h ip w it h p u bl ic he a lt h authorities and patient groups to find out where the pain points are. “ We’re c u r rent ly s t ud y i n g 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

CL code: NP-GB-ABX-JRNA-200001.

Date of preparation: March 2020

Sponsored by

Read more about vaccination through life at the GSK website: vaccinateforlife.com HEALTHAWARENESS.CO.UK 7

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The importance of vaccines for all 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.

DR PHILIPPA WHITFORD MP for Central Ayrshire and Chair All Party Parliamentary Group on Vaccinations for All

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mmunisation 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 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 ‘antivaccine’ 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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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

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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 2 million to 3 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.

dose of measles vaccine stalled at 85%. This is significantly shy of the 95% necessary to prevent outbreaks.

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 health care 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

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

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 U.S., 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.

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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 i n novat ion, t he U K ha s mu c h t o b e p r o u d of – f rom E dw a rd Jen ner ’s d i s c over y 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.”

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 t he second biggest impact on global public health after the

DR DOUG BROWN Chief Executive, British Society for Immunology 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.

WRITTEN BY: KATE SHARMA

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Why the insect cell system is a boost for vaccine development To combat emerging diseases, it’s crucial that vaccines and diagnostic assays can be made available quickly and costeffectively. One protein expression platform does just that.

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he World Health Organization (WHO) has a list of emerging diseases,” says Linda K ing, P rofe s s or of V i rolo g y at O x ford Brookes University and founder of Ox ford E x pres sion Te ch nolog ies, 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. 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 CrimeanCongo Haemorrhagic Fever (CCHF), MEDIAPLANET

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 diag nostic 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 healthrelated 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

LINDA KING Professor of Virology, Oxford Brookes University and Founder, Oxford Expression Technologies

cells, and they are deemed to be very safe. Plus, insect cells can be scaled up quickly and effectively.”

Using this technology, OET scientists produced 70 or 80 different variants of CCHF virus glycoproteins that have now been shortlisted to four. These are currently undergoing efficacy tests.

Vital that vaccines are quickly available in any outbreak “Crimean-Congo Haemorrhagic Fever doesn’t spread as easily as, say, Ebola,” says Professor King. “But CCHF has already moved to Turkey with isolated cases in southern Europe. In an outbreak situation, the Baculovirus-platform ensures t hat 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 made governments realise that this is an important area to invest in,” she says. “It was a reminder that when an outbreak does occur, it’s absolutely vital that vaccines and diagnostics are available.”

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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.

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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

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PROFESSOR MILES CARROLL Head of Research at the National Infections Service, Public Health England

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.

The large number of cases and EU funding afforded the PHE team a unique opportunity to study the immune response

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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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?

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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 diseasecausing 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.”

DR ARCHIE LOVATT Scientific Operations Director for Biosafety, SGS Vitrology

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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“More ‘real-world’ efficacy studies are needed” Leading vaccine expert Adrian Wildfire outlines the changes needed to ensure more vaccines coming into the market do ‘what they say on the tin’.

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iscussing the immediate need for more effective vaccines designed to combat seasonal epidemics like influenza and the SARSCoV-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 preclinical and early clinical modelling.”

“There is only 15%* efficacy for some strains of influenza, an all-time low and MEDIAPLANET

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.”

Vit a l me a s u re s of ‘re a l-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: 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.

ADRIAN WILDFIRE Scientific Director, SGS Life Sciences

“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 pict ure of likely outcomes in t he 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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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.

The simple solution for saving lives: invest in vaccines As we take stock of the year gone by, one word comes up repeatedly: measles.

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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.

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

two and three million deaths each year, most of them children. 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.

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 .

The benefit of vaccines Vaccines save lives from many other diseases. Today, immunisation against deadly diseases prevents between

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.

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

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ROBIN NANDY Chief of Immunization and Representative On The Leadership Team Of The Measles & Rubella Initiative, UNICEF

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 middleand 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

PIERRE VAN DAMME Professor in Vaccinology, University of Antwerp, Belgium

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.

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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

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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 vaccination-related 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 SouthEast 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.

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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