OSLO, Norway, SHANGHAI and KUNMING, China; 8 February 2022 — CEPI, the Coalition for Epidemic Preparedness Innovations, today announced that it will expand its collaboration with Shanghai Zerun Biotechnology Co., Ltd. (Zerun Bio) and its parent company Walvax Biotechnology Co., Ltd. (Walvax), a public company listed on the Shenzhen Stock Exchange (300142.SZ) to advance the development of a COVID-19 variant vaccine. CEPI will invest up to an additional USD$8.15 million to support a Phase I/II clinical trial in Mali which will evaluate the safety and immunogenicity of Zerun Bio’s prototype and multi-variant vaccine candidates. This will be the first clinical trial of the multi-variant vaccine, which has the potential to provide protection against a broad range of COVID-19 variants.

Including this latest funding, CEPI has now committed up to USD$25.1 million to this vaccine development partnership to support preclinical studies, early-stage clinical trials, process optimization and manufacturing scale-up of prototype and multi-variant vaccines. Results from a Phase I/II study of the prototype vaccine candidate, funded by CEPI, demonstrate that the product has a good safety profile and promising immunogenicity data. The data indicate that the prototype vaccine candidate induced a high level of immune response in adult subjects after two doses of vaccination, and the clinical serum demonstrated a good cross-neutralization effect on Beta and Delta strains. Preclinical studies showed that the multi-variant vaccine developed through the same technology platform also demonstrated a broad spectrum of cross-neutralization results for multiple Variants of Concern, including Alpha, Beta, Gamma, Delta, and Omicron, as well as for the prototype strain. The data from these studies will be submitted for publication in a peer reviewed journal shortly.

Enabling equitable access

CEPI, Zerun Bio and Walvax are committed to enabling global equitable access to this COVID-19 vaccine. Under the terms of the agreement, it is anticipated that vaccine output funded by CEPI’s investment will be procured and allocated through the COVAX Facility, which aims to deliver equitable access to COVID-19 vaccines for all participating countries, at all levels of development.

Zerun Bio’s commercialization plant for COVID-19 vaccines in Daxing District, Beijing, China, is expected to be put into use in 2022, enabling Zerun Bio to produce commercial volumes of COVID-19 vaccine.

I am pleased to expand CEPI’s partnership with Zerun Bio and Walvax, based on the promising early data for this vaccine candidate. COVID-19 continues to evolve, and we cannot predict which path it will take next, so it’s vital that we continue to invest in globally accessible vaccines that are effective against a broad range of possible variants. Such vaccines can put us a step ahead of the virus, so they are central to the long-term control of COVID-19, and vital to global health security.

Dr. Richard Hatchett

Chief Executive Officer, CEPI

I am thrilled that we and our subsidiary Zerun Bio have expanded the collaboration with CEPI in our shared goal of introducing new vaccine solutions to help fight the COVID-19 pandemic. I reaffirm that Walvax will continue to mobilize all internal resources to support and accelerate this project and fulfil our commitment of providing a safe, effective and affordable vaccine to help battle COVI-19 in the longer term.

Mr. Yunchun Li

Chairman of Walvax Board

We are very grateful to CEPI and its donors for the new funding to support a Phase I/II clinical trial in Mali which will evaluate the safety and immunogenicity of our prototype and multi-variant vaccine candidates. Our team is highly motivated by the new grant and will keep the momentum to work more closely with CEPI with a sense of urgency to achieve the goal of developing globally accessible vaccines that provide broad protection against COVID-19 variants.

Mr. Jiankang Zhang

Vice President of Walvax, CEO & President of Zerun Bio

This press release is also available in Chinese.