Needle-free vaccine delivery platform aims to end frozen storage needs and improve access

CEPI to initially provide up to US$1.6 million to aVaxziPen to advance development of needle-free vaccine technology

aVaxziPen's innovative vaccine delivery platform aims to improve access to vaccines by removing the need for frozen storage and enabling easier distribution and deployment

June 6, 2023; OSLO, Norway and OXFORD, UK: CEPI, the Coalition for Epidemic Preparedness Innovations, and aVaxziPen Ltd, a biotech company developing a novel needle-free vaccine delivery platform, have today announced a partnership to advance the development of two vaccines candidates (one protein and one mRNA-based) using aVaxziPen's solid dose vaccine-delivery platform, which could help end the need for frozen storage of vaccines, thereby improving equitable access to vaccines. CEPI will initially provide up to US$1.6 million to establish proof-of-concept for aVaxziPen's vaccine-delivery technology by evaluating stability, delivery and preclinical immunogenicity of both mRNA and protein-based vaccines developed using aVaxziPen's platform.

The potential of needle-free vaccines to end frozen storage

Advances in vaccine technology have been critical to the global response to COVID-19, but one of the challenges the world faced in getting these lifesaving vaccines to vulnerable populations—particularly those people in poorer countries—was the need to store them at low or very low temperatures.

The current generation of mRNA vaccines require frozen storage due to the fragility of mRNA molecules. Once removed from the freezer, these vaccines usually have to be used within a short timeframe. Removing the need for frozen storage would make mRNA vaccines significantly easier, and cheaper, to ship, store and distribute in low-resource settings. While protein-based vaccines do not typically require frozen storage, they often need to be stored at temperatures between 2-8°C, so developing a protein vaccine platform capable of withstanding temperatures of up to 40°C for at least 1-2 months would help to simplify last-mile delivery of these vaccines, even in the most remote regions of the globe.

aVaxziPen's solid-dose vaccine technology uses a pen applicator device and is designed to address these challenges by protecting the mRNA and proteins against degradation, potentially removing the need for frozen storage for mRNA vaccines, and the need for cold-chain storage altogether for protein-based vaccines. It does this through its proprietary solid-dose formulation technology which uses precision engineering to produce a thermostable, guaranteed solid-dose formulation. 

In addition to being thermostable, aVaxziPen's applicator device offers other potential benefits, including ease of administration (requiring no specialised-medical training) and it can be reused for 1,000 doses, helping to minimise waste. Its light and robust presentation also makes it ideal for shipment and storage.

If the initial preclinical proof-of-concept is successfully established, CEPI and aVaxziPen may agree to further the partnership by agreeing on vaccine candidates (to align with unmet vaccination needs in low- and middle-income countries) to take forward into Phase 1 clinical trials.

This project is the third to be announced as part of CEPI's January 2022 Call for Proposals, aimed at improving thermostability of—and thereby improving equitable access to—a variety of new vaccine platforms. This Call forms part of CEPI's wider strategic goal of harnessing innovative technologies to improve the speed, scale and access of vaccine development and manufacturing in response to epidemic and pandemic threats.
 

Enabling equitable access to vaccines

CEPI and aVaxziPen are committed to enabling global equitable access to vaccines developed through their partnership. Under the terms of the funding agreement, aVaxziPen has committed to ensuring supply for low- and middle-income countries (LMICs), production of vaccine volumes required to meet public health needs, affordable pricing for LMICs, and the potential technology transfer to LMIC manufacturers in line with CEPI's Equitable Access Policy.

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About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched in 2017, to develop vaccines against future epidemics. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need.

Prior to COVID-19, CEPI's work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus — it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).

CEPI has played a central role in the global response to COVID-19, supporting the development of the world's largest portfolio of vaccines against SARS-CoV-2 and its variants with a focus on speed, scale and access, as well as co-leading COVAX, the global initiative to deliver fair and equitable access to COVID-19 vaccines. CEPI is also the world's leading funder of R&D for broadly protective coronavirus vaccines which could protect against future variants of COVID-19 as well as other coronaviruses with epidemic and pandemic potential.

CEPI has embarked upon an ambitious US$3.5bn five-year plan — called CEPI 2.0 - to dramatically reduce or even eliminate the future risk of pandemics and epidemics. Central to the plan is CEPI's goal — supported by the G7 and G20 - to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days. Achieving this ‘100 Days Mission' would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic. Read the plan at endpandemics.cepi.net/

To read more about how the world can work together to #endpandemics, check out DISEASE X — The 100 Days Mission to End Pandemics, by CEPI's Chief Scientific Writer Kate Kelland, available here at Bookshop.org. All author proceeds go to the World Health Organization Foundation's COVID-19 Response.

About aVaxziPen

Based in the UK near Oxford, aVaxziPenTM is developing next-generation vaccination products targeting infectious diseases and emergent threat pathogens enabled by its proprietary aVaxziPenTM technologies. aVaxziPenTM creates and delivers vaccines in needle free, thermally stable, solid dose format that is applicable across all types of vaccines. Our aim is to transform the delivery of vaccines using needle free dosing and reduce or eliminate the requirement for cold chain storage to make a lasting positive impact on global health.

aVaxziPen's proprietary technology consists of a multi-use applicator coupled with a disposable cartridge containing a single, solid dose of vaccine which does not require reconstitution prior to use. The solid dose vaccine is administered quickly and easily by simply pressing the cartridge onto the upper arm. Our products are designed to enhance the recipient's immune response and offer significant benefits for patients, care givers, healthcare professionals and payers.

Our pipeline targets a range of common and emerging infectious diseases, inflammatory diseases, and allergies, and has been established through collaborations with world-class organisations, including BARDA DRIVe*, the Bill & Melinda Gates Foundation, Innovate UK, the University of Oxford, the Walter Reed Army Institute of Research (WRAIR), Imperial College London, and the University of Adelaide. We are also advancing several collaborations with leading organisations for use of our technology in the veterinary health setting.

aVaxziPen's experienced leadership team has a proven track record in the successful development and commercialisation of innovative products delivering high value outcomes for all stakeholders and is supported by a world-renowned Scientific Advisory Board.

*This project has been funded in whole or in part with US Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, DRIVe, under Contract No. 75A50119C00032.

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