Romina Di Marzo

Communication and Fundraising Manager, European Vaccine Initiative

Global collaboration is key to drive innovation in vaccine development.

When it comes to disease prevention, vaccines are our best weapon. The COVID-19 pandemic has put an unprecedented spotlight on the need to develop, manufacture and deploy vaccines swiftly for diseases that cross borders and populations.

Unfortunately, vaccine development is a complex, expensive and lengthy process. Without international mobilisation, public-private partnerships and sharing of resources and expertise, even the most promising and innovative solutions may not succeed.

Getting new vaccines faster

TRANSVAC is a collaborative initiative between more than 20 European leading research organisations, coordinated by the European Vaccine Initiative (EVI). TRANSVAC aims to establish a sustainable, disease-overarching vaccine infrastructure that can pool and leverage existing resources, expertise, technologies and other tools among the participating institutions.

This will create synergies that truly convert it into an accelerator of vaccine development, particularly at early and at-risk development stages. This initiative currently supports the development of innovative preventative and therapeutic vaccines against a range of diseases, both for human and veterinary use, mostly free of charge.

The COVID-19 pandemic has put an unprecedented spotlight on the need to develop, manufacture and deploy vaccines swiftly for diseases that cross borders and populations.

European COVID-19 vaccine trial accelerator network

VACCELERATE is a new pan-European clinical research network dedicated to the coordination and conduct of COVID-19 vaccine phase II and III clinical trials, constituted by 26 organisations across 21 countries. The network offers expertise, services, resources and solutions to speed up existing and upcoming development programmes and market authorisation for new vaccines and vaccination strategies.

The network will, among other aspects, address research questions of interest for European public health, such as vaccine efficacy against virus variants, vaccines for adolescents and children, pregnant women, immuno-compromised patients, longevity of vaccine protection, and trials on combination of different vaccines. In line with that, the European volunteer registry for vaccine trials has been established providing fast and efficient recruitment of trial participants.

Safe and effective vaccines are a public health good in constant demand. Such initiatives not only ensure rapid progress towards the development of new vaccines through concerted and coordinated efforts but also represent a blueprint for innovation to happen.

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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.

At 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 SARS Cov-2 spike protein receptor binding domain on the surface of the Hepatitis-B virus-like particles. 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.

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

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.

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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.

In 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 under-vaccinated groups who can then be caught up.

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.

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. 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.

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Nasal spray vaccines could help play a significant part in the fight against COVID-19.

Developing 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.

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.

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.

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.

Preclinical trials

Intravacc’s intranasal Avacc COVID-19 vaccine candidate not only induce high mucosal and systemic immune responses but are 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.”

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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.

“Our 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 have a 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 demonstrated how to use the NHS booking service. “We want to build trust and ensure that vaccination is as inclusive as possible,” says David.

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

Unlike the GP surgery, where there are often long waiting lists for face-to-face 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.

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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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.

The 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 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.

The processes to validate, approve and recognise new manufacturing facilities, an essential step in scaling up vaccine production, are still not agile enough.

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.

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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Dr Seilesh Kadambari

University Research Lecturer, Oxford Vaccine Group

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.

Individuals 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 evidence-based 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.

We encourage a two-way dialogue in the hope that these groups can trust us with providing evidence-based answers to queries.

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.

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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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.

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

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

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

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.

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

Making vaccines more affordable for all

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

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

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

How to drive vaccine costs down

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

Investing in ways of improving biological standards and assays to speed up investigation or proof-of-concept could lower costs too, as could new platform technologies to accelerate R&D and better regulatory science for faster approvals.

These shifts along the value chain of vaccine production would ultimately help lead to cheaper vaccines for those who need them most.

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