Value of Vaccines - Q2 2022

Q2 2022 | A promotional supplement distributed on behalf of Mediaplanet, which takes sole responsibility for its content

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Value of Vaccines

“We can prepare to react even quicker to the next pandemic.”

“There is a need for continued international co-operation to improve access.”

James Anderson, IFPMA

Javier López González, Silvia Sorescu and Andrea Andrenelli, OECD

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IN THIS ISSUE

“We have become familiar with many of the components of vaccines.”

Javier López González, Silvia Sorescu and Andrea Andrenelli, OECD

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Collaboration can help find a vaccine within first 100 days We must take pandemic preparedness farther, faster by ensuring a joint response to future outbreaks.

“We have not yet achieved equitable global access to COVID-19 vaccines.”

Sibilia Quilici, Vaccines Europe

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“Vaccines can help protect you and your family.”

Laetitia Bigger, IFPMA

Online

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ur 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.

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 highquality 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.

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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.

WRITTEN BY James Anderson Executive Director, Global Health, IFPMA

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Creating a more affordable and efficient vaccine development platform 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.

Paid for by Dyadic International, Inc

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.”

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

INTERVIEW WITH Mark Emalfarb President and CEO, Dyadic International, Inc WRITTEN BY Mark Nicholls

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he 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,

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can deliver faster, more-effective and equitable vaccine solutions, he says.

Protein production platform Mark Emalfarb is CEO of Dyadic International, Inc, 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

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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No trade? No vaccine: The vital role of trade during the COVID-19 pandemic 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.

V WRITTEN BY Javier López González Senior Trade Policy Analyst, OECD

ials, 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.

WRITTEN BY Silvia Sorescu Trade Policy Analyst, OECD

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.

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.

WRITTEN BY Andrea Andrenelli Trade Policy Analyst, OECD

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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).

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Developing vaccines for diseases with endemic potential All countries are facing challenges in ensuring that their populations are vaccinated, but not all countries produce all the goods needed to do this. ~Javier López González, Silvia Sorescu & Andrea Andrenelli, OECD

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.

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ndemic 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.

Find out more at oetltd.com INTERVIEW WITH Professor Robert Possee CEO, Oxford Expression Technologies Ltd WRITTEN BY

Mark Nicholls

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Almost 80% of European governments spend less than 0.5% of their healthcare budget on immunisation programmes.

Realising the full value of vaccination across the life course 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.

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y 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.

WRITTEN BY Sibilia Quilici Executive Director, Vaccines Europe

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 vaccinepreventable 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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Eco benefits of making sharps containers from recycled plastic 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.

C INTERVIEW WITH Amanda Haywood Head of Product Development, phs

WRITTEN BY Mark Nicholls

Paid for by phs

linical 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.

“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.”

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.

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.

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.

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.”

INTERVIEW WITH John Davies Global Category Director, Vernacare

Find out more at phs.co.uk

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. ~Sibilia Quilici Executive Director, Vaccines Europe

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The first COVID-19 vaccine was approved for emergency use only 326 days after the genetic sequence of SARS-CoV-2 was released. ~James Anderson Executive Director, Global Health, IFPMA

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