Serum Institute begins Phase I of experimental COVID-19 vaccine using Dynavax adjuvant

Serum Institute of India, the world's largest vaccine maker, is already mass producing and stockpiling AstraZeneca's Covishield shot, while Indian biotech players Bharat Biotech and Zydus Cadila are developing their own vaccine candidates (Representative File Photo)

Serum Institute of India, the world's largest vaccine manufacturer by volume and Nasdaq-listed biopharma company Dynavax Technologies Corporation said they began dosing the first participants as part of the Phase 1/2 clinical trial.

Serum Institute, has tied up with Dynavax to use the latter's adjuvant CpG 1018 in its experimental vaccine. An adjuvant is used to boost the efficacy of the vaccine.

The Phase 1/2 clinical trial will evaluate the safety and immunogenicity of Serum Institute vaccine candidate consisting of the SARS-COV-2 virus receptor binding domain (RBD) delivered as a virus-like particle (VPL), along with Dynavax's advanced adjuvant CpG 1018 plus alum.

The Phase 1 portion of the clinical trial will enroll 39 healthy volunteers and post the completion of the study a decision will be taken regarding the dosing of up to 216 subjects in Phase 2.

Serum has partnered with UK biotech company, Spybiotech, a spun-out of the University of Oxford to develop a COVID-19 virus-like-particle (VLP)-based vaccine. The vaccine has entered a Phase 1/2 trial in Australia.

"The collaboration with Dynavax is our effort in developing and exploring avenues to bolster our fight against the pandemic. We are hopeful that delivering the CpG 1018 adjuvant in the vaccine will enhance the immune response of the candidate," said Adar Poonawalla, Chief Executive Officer of Serum Institute.

"Through this we seek to provide our expertise and capability to produce large quantities of affordable vaccine to supply global needs," Poonawalla said.

"We are pleased to be partnering with Serum Institute of India to advance their approach to leverage a VLP utilizing the receptor binding domain of the SARS-COV-2 spike protein," said Ryan Spencer, Chief Executive Officer, Dynavax.

"We believe continued development of multiple programs is critical to ensure the availability of safe and effective vaccines that can protect the global population from this devastating disease in the near term and for years to come," Spencer said.

Serum Institute has been developing several vaccines for COVID-19 based on different platforms. The 'Covishield' in partnership with AstraZeneca-University of Oxford is based on non-replicating viral vector, Novavax - protein subunit and Codagenix - live-attenuated.