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.
Anand Ekambaram, Executive Director of Manufacturing and Supply Chain, CEPI, said: “Equitable access is at the heart of CEPI’s mission. aVaxziPen’s innovative vaccine delivery technology requires little-to-no training to administer, while simultaneously reducing the need for expensive and burdensome cold-chain storage, allowing for easier distribution and administration. These innovations would ultimately help to enable greater access to potentially lifesaving vaccines in lower resource settings when a future outbreak or pandemic threat emerges.”
Robin Cohen, Chief Business Officer, aVaxziPen, said: “We’re delighted to be working with CEPI as an important strategic partner to demonstrate the great potential of our vaccine technology. Collaboratively we will bring our solid-dose vaccine formulations to two vaccines to demonstrate significantly improved and extended thermostability, as well as testing immunogenicity with plans to progress into Phase 1 clinical trials. This is a great step forward in our mission to disrupt the vaccine market, providing improved vaccine coverage around the world, reaching under-served populations and markets.”