Value of Vaccines - Q2 2021

A Mediaplanet campaign focused on the

Value of Vaccines Kenya: Back in 2001, one of South Sudan’s East African neighbours - Kenya - was the first country to introduce the pentavalent vaccine with GAVI support.

In most developing countries, pneumococcal vaccine’s three doses are given after six, 10 and 14 weeks of a child’s life. Patan surveillance showed delivering the third dose as a booster after nine months gave Nepalese children better protection through to the age of five.

The new vaccine, MenAfriVac, is expected to dramatically reduce the impact of this terrible disease, saving as many as 150,000 lives by 2015.

The five-in-one vaccine – known as pentavalent – protects against 5 diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B and a major cause of meningitis and pneumonia, haemophilus influenzae type B.

Images provided by Gavi (gavi.org/news-resources/audio-visual/galleries)

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IN THIS ISSUE

How to accelerate the supply of vaccines to all populations worldwide

Vaccine surveillance is the science that is keeping us safe

Paula Barbosa Associate Director Vaccines Policy, IFPMA

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From an outside perspective, it’s easy to assume that once a vaccine is approved and jabs are being administered into arms that the brunt of the work is done.

Early decisions made the UK’s COVID-19 vaccination rollout a success Professor Anthony Harnden Deputy Chair, Joint Committee on Vaccination and Immunisation (JCVI)

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Increasing vaccine uptake among ethnic minorities Dr Samantha Vanderslott and Dr Seilesh Kadambari

University Research Lecturers, Oxford Vaccine Group

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n reality, the initiation of a vaccination programme opens up numerous threads of work – all of which inform the Government’s and the public’s decisions on what behaviour, interventions and vaccination strategy are required to keep the UK as safe as possible.

Throughout the pandemic, the UK has remained a world-leader in vaccine surveillance, data transparency and knowledge sharing. Public Health England (PHE) has built on tried and tested surveillance systems, which are used to monitor other vaccination programmes such as seasonal influenza.

PHE monitors vaccine coverage, vaccine effectiveness, the number of hospitalisations and deaths prevented by vaccination and the prevalence of COVID-19 antibodies in the population.

This data has been fundamental in the fine-tuning of our vaccination strategy and the wider public health response, including helping the Government to decide when it is safe to lift restrictions.

We also use this data to inform the public about the benefits of vaccination; this helps them to make an informed choice to accept vaccination.

The importance of monitoring vaccine coverage Vaccine coverage – how many people have had the vaccine – is a key indicator of the success of the programme.

Importantly, coverage data are also used to estimate the level of susceptibility in the population and identify undervaccinated groups who can then be caught up.

Data from these systems have also demonstrated the safety and real-world effectiveness of vaccines outside of the near perfect conditions followed in clinical trials.

PHE’s world-leading data on vaccine effectiveness after one dose and confirmed that using an extended schedule – with 12 weeks between doses – was the right decision.

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We also use this data to inform the public about the benefits of vaccination; this helps them to make an informed choice to accept vaccination.

This allowed the NHS to use the supply to work through the vaccination priority groups at pace, preventing thousands of deaths and hospitalisations over the first three months.

Vaccine surveillance helps monitor and reduce risks Our data on preventing onward transmission led to the decision for household contacts of immunosuppressed people to be prioritised for vaccination. The safety of the public remains the number one priority in all our work.

We will continue to monitor the safety and effectiveness of the vaccines and keep the public informed at every step, through transparent and regular publishing of surveillance data. This is integral in sustaining public confidence in our world-leading vaccination programme, while providing ministers with vital data to help us all return to normality.

Contact information: uk.info@mediaplanet.com or +44 (0) 203 642 0737

WRITTEN BY

Dr Mary Ramsay Head of Immunisation, Public Health England

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Engaging with BAME communities to increase vaccine uptake Pharmacy Manager, David Gallier-Harris wanted to help reach the local Black, Asian and minority ethnic (BAME) community in a push to tackle COVID-19 vaccine hesitancy.

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ur focus is to increase vaccine uptake and ensure delivery is as equitable as possible, as part of Asda’s culture engaging with local communities,” says David Gallier-Harris, who is Pharmacy Manager of Asda’s Cape Hill store in Smethick, Birmingham. He also leads the store’s vaccination hub, one of just three Asda store centres.

Wide ranging reasons for vaccine hesitancy Back in February reviewing the hub vaccination data, David became aware uptake was considerably lower among BAME communities than people from white ethnic backgrounds.

Wide ranging reasons have been suggested for vaccine hesitancy among BAME groups, including previous negative experiences of health services, religious acceptability and fears of being treated as experimental subjects.

“It’s really important to reach BAME populations because statistics show they’ve higher mortality if infected, and to achieve herd immunity we need as many people as possible vaccinated,” explains David.

We want to build trust and ensure that vaccination is as inclusive as possible.

Making vaccination inclusive David started by making direct contact with local faith leaders, informing them when different vaccination cohorts opened up, so they could encourage their communities to make appointments through the national booking service. David also spoke at Friday Prayer in the local Mosque, where he talked about the benefits of vaccines, addressed concerns, provided educational resources in different languages, and demonstrate how to use the NHS booking service. “We want to build trust and ensure that vaccination is as inclusive as possible,” says David.

Supermarket pharmacies providing support for your local community Supermarket pharmacies have become a hub for people of all backgrounds to access vaccines in their local community.

U INTERVIEW WITH Faisal Tuddy Superintendent Pharmacist, Asda WRITTEN BY Kirsty Elliott

INTERVIEW WITH David Gallier-Harris Pharmacy Manager, Asda WRITTEN BY Janet Fricker Find out more at asda.co.uk

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nlike the GP surgery, where there are often long waiting lists for face-toface appointments or incompatible working hours, the connected nature of a supermarket pharmacy means that you can drop in for your vaccinations at the same time as picking up your weekly shop.

Faisal Tuddy, Superintendent Pharmacist at Asda says: “Our in-store pharmacies are located at the heart of communities and easily accessible, which makes them a convenient option for priority groups living nearby.”

Joining the fight against COVID-19 As COVID-19 struck the country last year, British supermarket chain, Asda, wanted to find a way to help support the NHS, which was struggling to cope with the rising demand for COVID-19 vaccinations.

“In January, we became the first supermarket to support the NHS vaccination programme with in-store vaccination centres. Since then, our team of highly trained pharmacists have worked hard to deliver over 50,000 vaccinations to eligible patients” says Faisal.

In order to do this, the company reached out to the NHS to offer stores to help rollout the COVID-19 vaccine. Asda initiated the use of its extensive logistical network to help support NHS capacity. Focussing on non-essential business units to utilise space, they created three bespoke COVID-19 vaccination centres in Birmingham, Watford and London.

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With an increased understanding of the importance of vaccination in the community, uptake of the flu vaccine in 2020 was higher than ever.

The upcoming flu season The mass rollout of vaccines for COVID-19 has brought wider vaccination to the forefront over the last year.

With an increased understanding of the importance of vaccination in the community, uptake of the flu vaccine in 2020 was higher than ever. This year, we may see similar amounts of uptake, especially with the possibility of a booster requirement on the COVID-19 vaccine.

However, Faisal suggests that more could be done to reach a wider audience: “When it comes to the flu jabs. historically there has always been challenges to reach audiences that are younger than 60 years old.”

Free flu vaccinations are available to all those over the age of 50, or if you have certain health conditions, are pregnant, live with someone who is at a high risk from COVID-19 or are a front-line health or social care worker, you are eligible for a free flu vaccination. If you are not eligible for an NHS flu jab, you can still have that piece of mind by booking in with ASDA’s private service.

Pharmacies will continue to play a crucial role in helping to provide advice and support and reassurance for those in the community, long after the pandemic.

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Early decisions made the UK’s COVID-19 vaccination rollout a success Throughout the pandemic, the aim has been to prioritise those who are more likely to have severe effects and die from COVID-19, to protect individuals and ease the burden on the NHS.

E WRITTEN BY Professor Anthony Harnden Deputy Chair, Joint Committee on Vaccination and Immunisation (JCVI)

arly on, the Joint Committee of Vaccination and Immunisation (JCVI) considered a number of different approaches for the deployment of the COVID-19 vaccination programme. These included strategies to interrupt transmission of the virus and strategies to provide direct protection to those most at risk.

The evidence was clear that the older you are, the greater your risk of becoming seriously ill or dying from COVID-19. Even when other factors were considered, age remained the key factor that determined each person’s level of risk.

Prioritisation is based on saving lives The JCVI believed we could significantly reduce the number of deaths and hospitalisations by vaccinating the oldest first. Therefore, phase 1 targeted the over50s, frontline health and social care workers – who are a critical part in the fight against COVID-19 – and those with underlying health conditions. It is estimated that vaccinating everyone in these cohorts would prevent around 99% of deaths from COVID-19. The second phase continued down the age groups.

This simple age-based approach was operationally easy to deliver and critical for rapid deployment and high vaccine uptake.

Since then, over 40 million adults in the UK have received their first dose and over 30 million have now received their second dose.

Life-saving strategy made possible by the NHS The success of these decisions can be seen in the staggering pace and scale of the UK’s rollout. In early December, the first COVID-19 vaccine was administered.

Since then, over 40 million adults in the UK have received their first dose and over 30 million have now received their second dose.

For this, I give my thanks to our brilliant primary care and NHS colleagues in delivering the programme – as well as the public health experts, who have worked tirelessly to deliver the vaccines up and down the country and have analysed vital data on vaccine effectiveness to inform our roadmap back to normal life.

These achievements are remarkable. The UK’s vaccine programme has led the way in vaccine deployment strategy and many countries have followed our approach.

It is incredibly important that we do not lose momentum now and accept both doses of the vaccine when offered – this is the best way out of the pandemic and back to freedom.

How to accelerate the supply of vaccines to all populations worldwide Over the past few decades, the global regulatory environment has become more stringent and demanding to consistently guarantee the quality, safety and efficacy of medicines and vaccines.

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he increase in requirements by regulatory authorities has not been implemented equally across the world. Nowadays, we have a high heterogeneity in terms of dossier review, approval processes and timelines, with each country having specific data requirements and processes which often differ between countries. As such, it is virtually impossible for every country in the world to have access to medicines and vaccines at the same time.

Regulatory requirements under COVID-19 Unfortunately, while vaccines are widely recognised as the most important tool to exit the COVID-19 pandemic, regulatory requirements

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have not been harmonised and simplified across the world to expedite access.

It has highlighted some weaknesses in the system, more precisely in the regulatory management for manufacturing and controls. For instance, the processes to validate, approve and recognise new manufacturing facilities, an essential step in scaling up vaccine production, are still not agile enough.

There are multiple changes in process that can happen after a vaccine is first approved, such as new types of fridges used or tests performed. We can see dozens of changes each year, which you need to multiply by the number of countries where the vaccines are approved, resulting in thousands of

variation dossiers. This will become even more significant for COVID-19 vaccines as data will change at a faster pace than for regular vaccines.

Several countries perform testing on vaccine batches which is redundant and time-consuming, and not always using the same test method and applying the same specifications.

Initial COVID-19 vaccine batches have limited expiration dates. Therefore, redundant local testing reduces the remaining shelf life for a vaccine, potentially resulting in discarding expired doses.

The emergence of variants has led to the need to react quickly by developing, manufacturing, and approving new vaccines against those variants, for whom most of the above challenges will also apply.

WRITTEN BY Paula Barbosa Associate Director Vaccines Policy, IFPMA

The way forward There are four areas which provide solutions for the regulatory concerns, which are: 1. Science and risk based approaches 2. Global regulatory harmonisation 3. Use of reliance, work-sharing, and recognition processes 4. Digitalisation These solutions are not new and, whilst this pandemic has witnessed some progress at authority level, a lot needs to be done. Ultimately, quick and widespread access to medicines and vaccines is most important.

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Recognising vaccine innovation today for a healthy tomorrow With the emergence of COVID-19, the world is witnessing the crucial role of rapid vaccine development, and deployment, in protecting lives and economies.

V WRITTEN BY Ian Gray Sanofi UK & Ireland, Country Medical Lead & Head of Medical Sanofi Pasteur

accines play a pivotal role in preventing disease and save millions of people worldwide from illness, disability and death. Vaccines underpin a fundamental tenet of modern healthcare—that prevention is better than cure.

More than ever, advances in healthcare and the discovery of new medicines and vaccines are needed to ease the burden on the NHS and sustain healthy, productive communities.

Therefore, by aligning with UK government public health priorities, Sanofi believes that recognition and support of innovation in vaccine discovery, manufacture and roll-out are critical to prevent diseases significantly impacting the UK population and economy.

A healthy community, a healthy economy Comprehensive vaccination programmes underpin good public health and extend beyond prevention of disease in individuals. Vaccination reduces the risk of illness among unimmunised and vulnerable members of our communities through ‘herd immunity’. We also know that the burden of diseases, including those preventable by vaccination, falls disproportionately on the disadvantaged members of our communities. Vaccination programmes like those in the UK can help reduce inequality; however, more work is needed to address vaccine hesitancy and uptake among some ethnic minority communities, as experienced during the COVID-19 pandemic.

At the national level, the COVID-19 pandemic highlighted how a disease can place a devastating financial burden on individuals, businesses and healthcare systems, like our NHS. Preventing disease through effective and optimised immunisation programmes can reduce the burden on primary care, hospital admissions, disability, and death, and ultimately, healthcare expenditure and costs.

By introducing innovative immunisations and optimising current vaccination programmes, we not only support the health and well-being of people in our community, but we also reduce burden on the NHS and support its sustainability.

More than ever, advances in healthcare and the discovery of new medicines and vaccines are needed to ease the burden on the NHS and sustain healthy, productive communities.

Recognising innovation We have seen how the scientific and medical communities, supported by government, have worked to discover, develop and deploy vaccines against many infectious diseases, including

COVID-19. As we look towards health and economic recovery following the pandemic, it is essential to continue to recognise the value of immunisation and invest in the discovery, development and delivery of vaccines in both the short and long term. Effective policy and decision making are paramount to achieving this aim.

As we leave the European Union, the UK must remain an attractive place for life science companies to invest to ensure the health benefits of effective vaccination programmes are delivered to the UK population.

Furthermore, for the UK to maintain its status as a pioneer in the advancements of scientific research and development in disease preventable medicines and vaccines, sufficient investment and incentivisation is required to enable their discovery, development and eventual commercialisation for their use in the UK. By doing so, the UK will maintain its leadership position in disease prevention.

At Sanofi, we are committed to embracing innovation to discover and manufacture new vaccines to save lives and promote good health.

We are taking new approaches to vaccine discovery via a deeper understanding of the biology of the pathogen (e.g. the virus or bacteria causing the disease) and how the pathogen causes illness and is transmitted to others. We are exploring new, efficient ways to manufacture effective vaccines.

We are improving vaccine formulations to simplify the delivery and administration of vaccines in national immunisation programmes.

Looking beyond today We must continue to support the success of UK vaccine campaigns, ensuring that the uptake and coverage of new and existing immunisations are optimised and maintained. Crucially, all parties, government, policymakers, scientists, healthcare professionals, pharmaceutical companies and individuals have a responsibility to provide clear, transparent, accurate information about vaccination to ensure public confidence.

We must also remember that other infectious diseases have not disappeared during this global pandemic. That is why Sanofi are investing in vaccine innovation and development today to prevent ill health tomorrow.

This article was commissioned and written by Sanofi UK. Document number: MAT-GB-2102675(v1.0) Date of preparation: May 2021

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Sanofi, with its global vaccine entity Sanofi Pasteur, is a leading vaccine developer and manufacturer. Sanofi Pasteur’s vaccines protect more than half a billion people in the world. sanofi.co.uk

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New technology platform helps accelerate vaccine generation While there may be many reasons to lament the introduction of COVID-19 to the world, one positive outcome is the growth of rapid response platform technologies.

A

t the time that the global pandemic was declared, mRNA vaccines were little-known outside the specialist field of vaccine research. Since then, huge strides have been made to accelerate the development of new platforms and technologies.

As an organisation, we moved swiftly to advance our novel vaccine technology platform, originally developed at the University of Oxford. Thanks to a collaboration with the Serum Institute of India, the world’s largest vaccine manufacturer, our technology was trialled for the first time in humans in September 2020, in a vaccine targeting COVID-19.

The hope is that, with a growing realisation that we need to be ready for future pandemics – an awareness which COVID-19 exacerbated – comes a recognition of the need to have a suite of platform technologies to address them.

Being prepared and having technologies that can be easily and rapidly deployed is essential. That’s what makes our technology attractive.

New technology to accelerate vaccine generation The COVID-19 vaccine uses SpyBiotech’s unique protein “superglue” technology to display the COVID spike protein on the surface of the Serum Institute’s Hepatitis-B virus-like particle delivery mechanism. The superglue technology can be combined with a variety of different delivery platforms to present antigens to the immune system with unprecedented stability and high specificity, creating a “plug and display” solution critical for generating vaccines rapidly and safely.

Not only could this technology offer an effective solution for future variants of COVID-19, but the real value lies in its potential across a broad range of diseases for which there are no approved treatments: it has already established proof of concept in viral, bacterial, parasitic and chronic diseases as well as in cancer.

Increasing vaccine uptake among ethnic minorities We have been struck by how COVID-19 has affected the health and wellbeing of ethnic minority groups disproportionately. We need to address the reasons for low vaccine uptake rates.

I WRITTEN BY Dr Samantha Vanderslott University Research Lecturer, Oxford Vaccine Group

WRITTEN BY Dr Seilesh Kadambari University Research Lecturer, Oxford Vaccine Group

Find out more at spybiotech.com

WRITTEN BY

Sumi Biswas Chief Executive Officer & Chief Scientific Officer, SpyBiotech

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For information and materials on vaccination, check out the Vaccine Knowledge Project vk.ovg.ox.ac.uk

ndividuals from ethnic minority groups are more likely to have severe disease requiring intensive care admission and sadly succumb to infection than those from a white ethnic background. These outcomes are independent of age, gender or socioeconomic factors.

However, vaccine uptake has been low in certain communities and for lots of different reasons. These include specific concerns about vaccine safety, exposure to misinformation, reduced access to vaccines and historical distrust with institutions.

Asylum seekers have cited negative experiences with authorities, and some don’t trust public health messaging related to vaccines. Central government often use one-way messaging, which will sometimes miss these groups.

We encourage a two-way dialogue in the hope that these groups can trust us with providing evidencebased answers to queries and enable informed decision making before getting a vaccine.

Working with community organisations We found approximately 200 community organisations online that provide community, religious or social support to individuals and groups across the UK. We approached these organisations to invite us to any online meetings being held during the lockdown in order to provide information about the vaccine, answer questions and encourage dialogue.

Our intention has been not to overwhelm people with information, so we do not use presentation slides or overly scientific language. The majority of our meetings are therefore

spent listening to concerns or questions, addressing these directly and encouraging conversation.

We have spoken to organisations that support asylum seekers, refugees, interfaith groups and elderly ethnic minority citizens. Concerns have ranged from the risk of deportation by registering for a vaccine, addressing misinformation circulating in specific communities and discussing a range of vaccine safety concerns.

Concerns have ranged from the risk of deportation by registering for a vaccine, addressing misinformation circulating in specific communities and discussing a range of vaccine safety concerns.

Who is involved?

This initiative is conducted by Dr Seilesh Kadambari and Dr Samantha Vanderslott. We are based at Oxford Vaccine Group and use information and materials from the Vaccine Knowledge Project.

The Vaccine Knowledge Project has also worked with the British Islamic Medical Association to develop FAQs about vaccines and vaccine ingredients translated into over 100 different languages and available on the website. This resource has been shared with communities through these online conversations.

Our aim has been to provide individuals with sufficient confidence to receive a vaccine and therefore ensure protection against a pandemic that has exacerbated disparities.

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How nasal spray vaccines can help combat needle phobia Nasal spray vaccines could help play a significant part in the fight against COVID-19.

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eveloping new and innovative delivery methods for vaccines can play a significant part in helping to stop the spread of major diseases such as COVID-19.

While needles and injections are the most common way of administering vaccination, the advantages and attraction of nasal spray vaccine for viral respiratory infections are gaining prominence.

Dr Jan Groen, who has spent much of his professional life in healthcare with a strong background in vaccine development, indicates that in COVID-19 (SARS-CoV-2) alternatives to injection for vaccine delivery could prove crucial in some populations and cultures.

New research under way into nasal spray vaccines At present, there are more than 250 COVID-19 vaccines in development around the world, though only eight are nasal sprays and only one of those developed in Europe, from Dutch developer Intravacc, has at this stage moved beyond pre-clinical trials and toward a phase I trial.

SARS-CoV-2 vaccines that are currently approved are all based on intramuscular immunisation, while Intravacc’s approach uses its proprietary outer membrane vesicle (OMV) vaccine technology platform, which can be used for developing both viral and bacterial vaccines.

The Avacc COVID-19 vaccine is based on purified and concentrated non-infectious, immune stimulatory vesicles from bacteria that are linked to recombinant stabilised spike protein of SARS-CoV-2 thereby creating the Avacc vaccine that will be administered intranasally. Avacc will be tested in a first in-human clinical study in January 2022. These OMV vesicles can form the basis of new and evolved vaccines for COVID-19 and many other infectious diseases, or combination vaccines, for example for the development of a combined COVID-19-Flu vaccine.

©Photo by Frank van Biemen

It is a relatively easy way to make this type of vaccine available for developing nations because needles are more complicated and present the risks of infection, while nasal sprays are easy to administer.

The use of a nasal spray There is an array of benefits from use of nasal spray vaccines, particularly for respiratory viruses.

Dr Groen says: “The beauty of a nasal spray vaccine is that it is used in the nose, where the virus replicates and that will lower the risk of mutations. It is quickly induced, giving local mucosal immunity, with fast protection after the first vaccination and it can also be mixed with all other vaccines on the market.”

With 35% of adults and up to 50% of children having a fear of needles, nasal spray vaccines are an appealing alternative for large parts of the population.

It also means that those delivering the vaccine may need less training than those administering it via an injection. “It is a relatively easy way to make this type of vaccine available for developing nations because needles are more complicated and present the risks of infection, while nasal sprays are easy to administer.” he adds.

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INTERVIEW WITH Dr Jan Groen CEO, Intravacc WRITTEN BY Mark Nicholls

Preclinical trials Intravacc’s intranasal Avacc COVID-19 vaccine candidate not only induces high mucosal and systemic immune responses but is also cheap to manufacture in high quantities and can be stored at 4°C for up to five years.

In case of a pandemic, synthetic or recombinant peptides and/or proteins derived from sequence analysis of the pathogen can be quickly produced and coupled to the OMVs. Dr Groen, who has been CEO of Intravacc since May 2020, says that from preclinical trials the early indications are that the vaccine offers 100% protection against COVID-19 with no damage to the nose or lungs.

The aim is for the nasal spray vaccine to be available by the end of 2022 with two doses administered three weeks apart.

Childhood vaccines Intravacc has more than a century of experience in vaccine development with a high proportion of all childhood vaccines globally currently containing the company’s knowhow or technology.

Dr Groen also believes that a safe and easy-to-administer nasal vaccine with no side effects will help enhance uptake of COVID vaccine, particularly among those with needle phobia.

He adds: “We are very pleased with this pre-clinical data of our revolutionising intranasal Avacc candidate vaccine. This allows us to move quickly towards an in human combined phase I and II clinical trial.”

Intravacc is an upcoming contract development and manufacturing organisation for infectious diseases and therapeutics.

The company offers a wide range of expertise and is the bridge between your discovery and the start of your phase I/II clinical trials in humans. intravacc.nl

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