Kaidre Bendjama

CSO, NEC Oncolmmunity, an NEC Bio Company

Scientists are using artificial intelligence (AI) to quickly design vaccines tailored to individual patients in oncology and universal designs for infectious diseases. This innovation could revolutionise the treatment landscape.

In the complex field of vaccine development, AI isn’t just a game-changer. It could also be a lifesaver. For instance, NEC Bio uses state-of-the-art machine learning technology to design vaccines that could significantly improve outcomes for cancer patients. The company has already developed applications in the oncology space and is looking to repeat the same success in infectious diseases.

“In 2019, the company decided to make AI-based drug development a growth area,” explains Saverio Niccolini, CEO at NEC Oncolmmunity, a subsidiary of NEC Bio. “Many biotechs try to acquire AI capabilities without having a deep understanding of it. Whereas, AI is in our DNA.”

Modelling the entire immune system with AI

By using AI technology to model the body’s entire immune system, scientists are able to create vaccines, in oncology, tailored to individual patients. “This type of personalisation is only possible because of AI,” says Niccolini. “Think of it this way: there are millions of cancer cells in the body with different mutations. There are also millions of cells that can stimulate potential immune responses to kill the cancer. These vast numbers can only be computationally resolved with AI modelling, which mimics the molecular processing happening inside each of these cells.”

AI has also put rocket boosters under the company’s vaccine development timelines. “Engineering a vaccine in a wet lab can take months,” says Niccolini. “Yet, with artificial intelligence, we can design a targeted vaccine, in silico, in a matter of days.”

An example of this is the company’s personalised vaccine for patients with head and neck cancer. While still in clinical trial, so far, the results look promising. “In a significant proportion of these patients, the cancer returns within two years of the first treatment,” explains Kaidre Bendjama, CSO. “To prevent recurrence, we created a bespoke vaccine in partnership with a biotech firm. We’re pleased to say that none of the patients in the trial who were given the vaccine have experienced a relapse, and there have been no reported safety issues. Ultimately, if the trial is successful and the vaccine is approved, it could change the treatment landscape for various cancers by providing patients with a new class of targeted therapy.”

With artificial intelligence, we
can design a targeted vaccine,
in silico, in a matter of days.

Creating universal vaccines for infectious disease

The company has now repurposed its AI oncology model to create universal vaccines for various infectious diseases, including HBV and influenza. It has also partnered with CEPI (the Coalition for Epidemic Preparedness Innovations) to advance the development of vaccines that provide broad protection against SARS-CoV-2 variants and other betacorona viruses.

“Unlike oncology vaccinations that are personalised to the patient, we aim to create universal infectious disease vaccinations that are targeted at whole virus families or across a range of virus variants,” says Bendjama. “However, it’s still early days. Animal studies have yielded interesting data and look promising for future clinical applications.

Accelerating the path from drug discovery to market

While it is certainly challenging to be working in the vaccine development field, it also presents us with an exciting opportunity to apply NEC Bio’s expertise in AI, says Niccolini. “Although we can design vaccines quickly with AI, we still face the long wait for drug approvals through clinical trials,” he says.

“This is understandable because there needs to be rigorous analysis of the impact of new drugs on patients. However, as we recognised during the pandemic, the process needs to be accelerated, which is why we are open to collaboration with pharma companies and not only offer our drug development technologies but also ICT technologies that can potentially shorten the operational timelines. Relying on pharma partner’s clinical development expertise we believe that we can bring the drug to the patient faster.”

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Vaccines have been shown to be one of the most successful healthcare interventions of our time, saving up to 5 million lives globally each year.

By preventing diseases and reducing the demand and misuse of antibiotics, vaccines are a key ally against antimicrobial resistance, which could claim 10 million lives a year by 2050.

Celebrating vaccine achievements

Vaccination led to the complete eradication of smallpox by 1980. It also led to the near elimination of polio, with the European Region declared “polio-free” in 2002. Over one in five child deaths are being averted globally thanks to the introduction of the MMR vaccine. And today, increasing vaccination rates for HPV and hepatitis B could allow us to see a world free of vaccine-preventable cancers tomorrow.

If we want our children to grow in Europe free of vaccine-preventable diseases and cancers, we need a significant paradigm shift to support sustainably prevention and immunisation policies.

A need for vaccination programmes

However, these unique public health features that vaccines bring cannot be achieved in the absence of adherence to vaccination programmes by the population.

Flu vaccination can protect against influenza and its related complications and save up to 332 million Euros in healthcare costs in Europe by freeing hospital beds and drastically reducing visits to healthcare professionals. Still, every year, up to 72,000 people die of influenza-associated respiratory disease in Europe.

The issue lies in the way immunisation programmes are supported politically and financially. Almost 80% of European governments spend less than 0.5% of their healthcare budget on immunisation programmes.

Achieving equitable vaccine access

Two years since the WHO declared COVID-19 a pandemic and despite having sufficient production of vaccines to meet the world’s needs, we have not yet achieved equitable global access to COVID-19 vaccines. The massive global vaccination campaign run to achieve equitable access has been significantly weakened by a lack of country readiness, resources and infrastructure, as well as vaccine hesitancy.

The consequences of the Russian invasion of Ukraine could amplify the threat of vaccine-preventable diseases even further as past evidence has shown that viruses spread even more rapidly in the context of humanitarian and sanitary crises.

If we want our children to grow in Europe free of vaccine-preventable diseases and cancers, we need a significant paradigm shift to support sustainably prevention and immunisation policies.

Permanent high uptake of routine vaccination across the life-course in all countries is the best way to be prepared against external threats so that resources and attention in times of crisis, being a financial crisis, a pandemic or a war, can remain focused on what could not have been prevented.

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Andrea Andrenelli

Trade Policy Analyst, OECD

Silvia Sorescu

Trade Policy Analyst, OECD

The production, distribution and administration of vaccines is a highly specialised endeavour, the result of a complex interplay of many inputs, underlining the vital role of global trade and cross-border co-operation in supporting access.

Vials, cold boxes for transport, dry ice to maintain cold temperatures during transit, freezers for storage and syringes: we have become familiar with many of the components of vaccines since the outbreak of the COVID-19 pandemic. The vaccine supply chain, from production and storage to distribution and the final jab in the arm, is a complicated business, requiring logistics expertise and access to goods produced across a range of countries. Then there are the vaccines themselves, which require many active and inactive ingredients and can only be produced after a specific combination of research and development, skills and technologies.

Global access to COVID-19 vaccines

Global trade in vaccines, including COVID-19 vaccines, was 26% higher in the first six months of 2021 than it was for the whole of 2020. This is unprecedented. Five economies – Belgium, Germany, the United States, China and Spain – accounted for 73% of the value of these exports in 2021.

Robust global supply chains therefore played a vital role in providing access to COVID-19 vaccines for many countries that otherwise lacked the capacity to produce them (although for many lower-income countries access remains a challenge).

All countries are facing challenges in ensuring that their populations are vaccinated..

Global supply chains at work

From the start of vaccine clinical trials in the first quarter of 2020 to vaccination campaigns a year later, the world saw a 66% increase in global exports of consumable materials used to manufacture vaccines, such as cell culture media or filters. A similar pattern emerges for packaging materials for COVID-19 vaccines, such as vials or rubber stoppers, where trade over the same period grew by over 18%. Moreover, trade in some specialised inputs underpinning the manufacture of COVID-19 vaccines increased more than five-fold.

This shows global supply chains at work. Agile and resilient supply chains, enabled by global trade, support access in the face of unprecedented changes in demand for the products needed to fight COVID-19.

Continued international co-operation

All countries are facing challenges in ensuring that their populations are vaccinated, but not all countries produce all the goods needed to do this. There is a need for continued international co-operation to improve access. This should be coupled with a continued push to streamline trade-related processes at and behind the border and more and better co-ordination of logistical processes. This will help ensure timely access to vaccines for all.

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Amanda Haywood

Head of Product Development, PHS

New-look clinical waste containers are being made from up to 100% recycled plastic as suppliers seek to support a wide range of organisations in cutting their carbon footprint.

Clinical waste containers made from recycled plastics are helping companies reduce their carbon footprints. The use of recycled materials for the sharps containers means businesses could avoid the recently introduced Plastic Packaging Tax in the UK.

Fifth generation

The ‘fifth-generation’ Sharpsafe and Clinisafe containers are being supplied following a partnership between hygiene services provider phs Group and Vernacare, which produces the new-look containers.

Vernacare’s global category director John Davies says the penetration-resistant containers used for clinical waste from washrooms, hospitals, dentists and veterinary practices meet stringent safety regulations and are made primarily from recycled plastics, compared to virgin plastic used in previous models.

“The key point is that recycled plastic has a lower carbon footprint than virgin plastics because the amount of energy required to produce them is less,” says Davies.

The key point is that recycled plastic has a lower carbon footprint than virgin plastics because the amount of energy required to produce them is less.

John Davies

Making a difference

Phs’ head of product development, Amanda Haywood, explains that her group has switched its entire range of containers to recycled content containers produced by Vernacare.

“Because we are actively seeking ways to reduce our carbon footprint and improve our sustainability, it was an ideal opportunity for us to make a very big difference,” she says.

“We move a lot of sharps containers; we have contracts for government vaccination and testing stations, and a massive range of customers from dentists to tattoo parlours, so we saw this as a great way to dramatically reduce our carbon emissions on that particular service.”

Colour change

The containers have the same features and benefits, but the new model is grey with colour coded lids to denote the waste stream in accordance with the regulatory colour coding requirement, rather than all yellow.

Davies explains that this is because grey is the most efficient and cost-effective colour to produce in terms of design and toughness from recycled plastic. The body of the containers is made of at least 30% recycled content, and in many cases 100% recycled content.

That helps companies mitigate the impact of the Plastic Packaging Tax, which imposes a £200 per tonne levy on plastic products made with less than 30% recycled content.

Carbon footprint

With phs’ increased focus on corporate social responsibility and reducing carbon footprint, Haywood says: “Each company we deal with has their own internal corporate responsibility programme and everybody is challenged with reducing their carbon footprint so everything that helps our customers – and their customers – in that direction is very well received.”

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New technologies and manufacturing approaches could help make vaccine development more affordable and accessible for a global population.

The challenge in creating vaccines to tackle a pandemic scenario lies in making them affordable and accessible for a global population. While higher income nations can fund development, purchase and distribution for their populations, cost remains an issue to low-and-middle income countries.

But industry expert Mark Emalfarb believes the key to a more rapid, equitable and cost-effective solution lies in new technologies and better manufacturing approaches for the way proteins are created for vaccine development.

COVID challenges

COVID-19 exposed weaknesses in vaccine development, access, supply and distribution in both developed and emerging nations. This, he believes, can be addressed by enabling all countries to produce their own affordable and effective vaccines and antibodies.

Using widely-available and economical products – such as aluminium hydroxide (alum) as an adjuvant, with an antigen and saline – with readily available and cost effective microbial fermenters, can deliver faster, more-effective and equitable vaccine solutions, he says.

Protein production platform

Mark Emalfarb is CEO of Dyadic International, which has developed the C1 protein production platform to shorten the time to develop and manufacture unparalleled amounts of affordable recombinant protein vaccines doses and antibodies using standard microbial fermentation vessels at flexible commercial scales.

The expression system, based on the fungus Thermothelomyces heterothallica will help combat pandemics and address health inequity, in addition to increasing vaccine and therapeutic production and supply.

Biological outbreaks

His company has explored how the technology can be deployed for pandemics and biological outbreaks over several years, including participation in the ZAPI (Zoonotic Anticipation and Preparedness Initiative) programme.

The programme has set up tools and platforms ready to be put into production for vaccines and monoclonal antibodies to counter emerging infectious diseases.

“When the COVID pandemic came, we already had the capabilities of satisfying a global demand for antigens which are used in recombinant protein vaccines,” he says. He describes it as “unfortunate” that this solution “did not receive the attention and funding” to combat the COVID-19 pandemic.

COVID-19 exposed weaknesses in vaccine development, access, supply and distribution.

Preparing for future pandemics

A vaccine development platform supporting preparedness for future pandemics empowers developing nations to make their own vaccine in situ because it is transferrable. As a result, they can be less reliant on industry, he explains.

The C1 technology, which has no endotoxins, can make ‘massive amounts’ of antigens and can be coupled with alum, a time tested adjuvant which has been used for decades even in children vaccines.

“As all countries have access to alum and standard E. Coli microbial fermenters it is the logical choice,” says Emalfarb. “The idea was to keep it simple and affordable so it can be manufactured in middle and lower income countries, as well as in the EU and US.”

Therapeutic treatments

Beyond COVID-19 vaccines, the platform has the potential to produce many other necessary vaccines and antibodies for infectious diseases such as HIV, influenza, malaria, HPV, rabies, West Nile virus and Zika.

“The C1 platform is amenable to make monoclonal antibodies and other therapeutic treatments faster, in larger quantities more affordably,” he says. “You put in a DNA sequence and out comes a protein; it can be an antigen for vaccine or monoclonal antibody to treat disease.”

Alternative space

Emalfarb acknowledges that his organisation needs partners in big pharma organisations but underlines that the technology will “help the world get access and affordability to vaccines and treatments.”

“We hope to empower the world to sustainably produce its own biological products, whether they be antigens for vaccines, antibodies for therapeutics or other types of drugs so they can take their destiny into their own hands and not have to solely rely upon industry to take care of their citizens.”

Dyadic is looking to out-licence the C1 technology platform, and underlines it is scalable, easy to implement and cost effective, using existing standard equipment such as stainless-steel microbial fermenters or single use bio-reactor bags.

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The challenge is not getting hold of COVID-19 vaccines, it is getting vaccines into arms. The healthcare community is continuing to showcase the value of vaccines throughout one’s life course.

Over the last two years, the global healthcare community’s efforts in mounting a response to COVID-19 have materialised. This pandemic has brought home the power of vaccines to save lives and protect the vulnerable. Breakthrough new vaccines and a historic scale up of production and deployment have resulted in the largest mass vaccination campaign the world has ever seen.

We now have to redouble efforts to accelerate countries’ mobilisation and remove barriers to efficient distribution and administration of COVID-19 doses, as the risk perception with Omicron has changed.

Global pandemic response

The biopharmaceutical industry took up the challenge to develop, manufacture and deliver safe and effective tools to combat COVID-19, including vaccines. The strength of a robust innovation ecosystem – decades of partnerships, scientific exploration and investment – enabled the development of technologies such as mRNA and viral vector COVID-19 vaccines, a process that would have taken years if started from scratch.

All companies were asked to ramp up manufacturing capacity to meet the global need, with 14 billion doses produced today. It is now publicly recognised that there is more supply than demand globally. The demand is going down, so much so that the Indian company, Serum Institute, halted its production last December, as Aspen in South Africa might have to do this month.

Getting vaccines into arms

But despite collective efforts, equitable access to COVID-19 vaccines remain a challenge. Countries face implementation bottlenecks, including funding gaps, weak health systems and infrastructure, competing health priorities and COVID-19 fatigue. Vaccine hesitancy has also had a serious impact and this may affect other vaccination programmes.

Healthcare systems and infrastructure need to be stronger, financing for in-country delivery must be prioritised and the biopharmaceutical industry will continue to work with all stakeholders on three overarching priorities so that COVID-19 vaccines reach those who need them the most.

Vaccines for life

The COVID-19 pandemic has shown that when we work together, we can achieve more than we ever thought possible. But there is more to be done. Vaccines can help protect you and your family from over 30 different infectious diseases – not just in childhood, but at every age and stage of life. Together, we can give vaccines the greatest chance to make an even greater impact on our health, our communities and our world.

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Scientists are working on a new vaccine for Crimean Congo haemorrhagic fever (CCHF) amid fears that the climate crisis could lead to the geographical spread of the potentially fatal virus.

Endemic to Africa, the Balkans, the Middle East and some Asian countries, CCHF is transmitted to humans via tick bites or contact with virus-infected livestock, and with a risk of human-to-human transmission.

Affected individuals experience intense flu-like symptoms that can progress to more serious effects including bleeding into the skin, kidney and liver failure, and acute respiratory distress syndrome.

Vaccine development

Professor Linda King from vaccine development specialists Oxford Expression Technologies (OET) says: “With climate change, the geographical spread of the tick is increasing and there is concern of this disease coming into areas of southern Europe.” The UK also reported one case this year, which was caught overseas.

Founded in 2007, OET has created a baculovirus expression system and is using its protein expression platform technology to develop a specific CCHF vaccine with various collaborators. A Phase I trial is expected in the next few years. The project is funded as part of the UK Vaccine Network (UKVN) to develop vaccines for diseases with epidemic potential in developing countries.

Great unknown

While outbreaks of CCHF are not currently on the same scale of other notable virus diseases, the threat of a widespread epidemic remains, underlining the urgent need for an effective and affordable vaccine, explains OET CEO Professor Robert Possee.

CCHF has a mortality rate of up to 40% and those that do recover can be left with quite debilitating illness.

Professor King says: “It is a great unknown because all viruses have the potential to mutate and change and you never know if something may happen that makes it more transmissible.”

Design strategies

OET technology – which makes proteins in insect cells for vaccine development – has also been used for COVID vaccines, where collaboration was crucial to cut timelines and bureaucracy whilst maintaining rigorous processes.

“It demonstrated that if you have platform technologies that are trusted and proven, they can be harnessed relatively quickly to produce a vaccine,” she adds.

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We must take pandemic preparedness farther, faster by ensuring a joint response to future outbreaks. 

Our efforts against COVID-19 have surfaced critical learnings, including the need to establish a global foundational capability, fit for purpose ahead of the next health emergency.

Key learnings for a better vaccine ecosystem

We have witnessed the importance of solid multistakeholder collaborations to develop pandemic countermeasures. We have also seen the need to build a robust, functional and decentralised vaccine ecosystem to ensure the world is better protected against infectious diseases today and can respond faster to future pandemic outbreaks.

The first COVID-19 vaccine was approved for emergency use only 326 days after the genetic sequence of SARS-CoV-2 was released. This was the fastest vaccine development ever, slashing by a fifth the previous record.

This speed of response has been key to change the impact of COVID. Now, we can prepare to react even quicker to the next pandemic and ensure equitable access to new innovations sooner. With sustained political and industry leadership and collaboration, we could cut this time to a third.

Our collective ability to foster and maintain a sustainable innovation ecosystem will determine the success of this ambitious initiative.

Success ingredients for the 100 Days Mission

Spearheaded by the Coalition for Epidemic Preparedness Innovations (CEPI) and supported by the G7 UK Presidency, the 100 Days Mission aims to develop and deploy high-quality diagnostics, therapeutics and vaccines in just 100 days after a new pandemic threat is identified. 

This programme is our best shot at preventing the next emerging pathogen from reaching pandemic proportions, because the faster an effective vaccine is developed, approved and deployed, the faster the next Disease X can be contained and controlled.

For this, the biopharmaceutical industry will build a portfolio of promising candidate vaccines, treatments and technologies against pathogens with epidemic and pandemic potential. These efforts will work best if paired with improved surveillance infrastructure and regulations for the immediate sharing of pathogen data, so that threats are quickly detected and candidate tools swiftly tested.

Equally important, we need to standardise regulatory processes to speed up market access and expand manufacturing capacity so that these tools are deployed faster, fairly and equitably in future health emergencies.

Our collective ability to foster and maintain a sustainable innovation ecosystem will determine the success of this ambitious initiative. Academia, national governments, international organisations, private companies, regulatory officials and manufacturing sectors have roles to play. United for a common goal, rather than working alone, we can go farther and faster.

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Vaccines have been thrust into the spotlight like never before during the pandemic. Suddenly, we are all talking about them – how they are created, how they are tested and when the rollout came, which one we had.

The focus during this pandemic is on vaccines for one disease, COVID19, understandably so. But the UK’s vaccination programme includes free vaccination against 21 infectious diseases, including COVID-19. 

The programme as a whole saves untold lives and NHS resources beyond COVID every day and we should never forget its value, which has been demonstrated over many years. 

Implementation of a national programme

In 1941 in England, there were 50,804 cases of diphtheria. Vaccination was introduced in 1942 and has continued ever since, now given as part of the childhood immunisation programme. In 2019 in England, there were only 10 cases reported. 

In 1956 in England, there were 92,410 cases of whooping cough, a disease which can be dangerous for young babies. Vaccination was introduced in 1957, and in 2019 there were 3,994 cases – not perfect, but a huge improvement.

Vaccination has prevented more serious diseases than any other advance in recent medical history, helping to reduce the burden on the NHS and ultimately saving many lives.

The value of vaccines continues to be demonstrated today. Take the shingles vaccine for older people. In the first five years of the shingles vaccine programme, there were 49,000 fewer GP visits, 1,800 fewer hospitalisations for shingles and its complications, that saved the NHS an estimated £10.5 million. 

A study published in the Lancet recently reminded us all of the importance of the HPV vaccine. It showed that HPV vaccination is cutting cases of cervical cancer by nearly 90%. Cervical cancer is the fourth most common cancer in women around the world, killing more than 300,000 globally each year. This study demonstrates that the vaccine is clearly saving women’s lives.

Most successful medical advancement 

Vaccination has prevented more serious diseases than any other advance in recent medical history, helping to reduce the burden on the NHS and ultimately saving many lives. 

Today, the COVID-19 vaccine programme remains an essential tool in our armoury against SARS-COV-2. 

As you get your COVID-19 booster or flu vaccination this winter, don’t forget that in addition to helping us fight this pandemic, researchers around the world are also developing vaccines to help fight as many diseases as possible, to help save lives around the world.

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A new ceramic skin patch is being used as a rapid response to control outbreak situations. It is also helping deliver vaccinations more easily and efficiently.

Mike de Leeuw, CEO of MyLife Technologies, the pharmaceutical company which has created the ceramic skin patch for vaccine delivery says: “With only five grams of mRNA-vaccine, basic field labs can produce up to one million vaccine patches within a few days to protect healthcare workers as a virus outbreak unfolds, anywhere in the world. Today, with standard jabs, that is less than 50,000.”

MyLife Technologies has partners in a clinical trial using an approved mRNA COVID-19 vaccine. It is demonstrating the benefits of their patches with HPV vaccines for low-and-middle-income countries; and it is accelerating scale-up to full-scale manufacturing.

These microneedles are like a ceramic sponge, yet are very strong and can carry, stabilise and quickly release most types of vaccines. They are applied within 30 seconds like any other skin patch.

Alternative vaccine delivery

The ‘patch’ is smaller than a fingertip and features a hundred, minute ceramic microneedles. De Leeuw says: “These microneedles are like a ceramic sponge, yet are very strong and can carry, stabilise and quickly release most types of vaccines. They are applied within 30 seconds like any other skin patch. The microneedle tips never touch a nerve or a blood vessel, making vaccination painless.”

Microneedle patch-technology is listed number one for the future of global vaccination by VIPS, the largest NGO-consortium evaluating vaccine technology. This is because top layers of the skin contain specialised immune cells that process vaccines against viruses and bacteria. Delivering vaccine in the first 150-400 micron of skin is much more efficient than vaccination with jabs into muscle tissue, where these cells are not found normally.

The company has shown efficacy in Influenza-A trials in animals, and it successfully demonstrated safety/tolerability with human volunteers. Various clinical trials with different vaccines have shown that skin vaccination requires 5-20 times less vaccine to achieve equivalent protection compared to standard jabs.

De Leeuw concludes: “We offer our patches for NGO-backed projects to speed-up vaccinations in LMIC’s. Our ceramic patches avoid needle stick anxiety and can eliminate expensive cold chain distribution. Especially with HPV, the cause of many smaller cancer diseases, this can help to raise the vaccination rate in adolescents worldwide.”

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