YS Biopharma Co., Ltd., a China-based global biopharmaceutical company, announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for the Investigational New Drug Application (IND) for PIKA COVID-19 vaccine.

Presently, the vaccine is in the phase three, multi-country, multi-centre clinical trial carried out in Southeast Asian and Middle East countries. The vaccine includes PIKA adjuvant and a stable trimeric form of the recombinant SARS-CoV-2 spike (S) protein as its main antigen component.

The planned study in the USA is a Phase one, open label, dose-escalation study to assess the safety, tolerability, and immunogenicity of a single booster dose of the vaccine in healthy adults, who have completed a primary COVID-19 vaccine series. It is expected to offer useful information about PIKA COVID-19 vaccine as a heterologous booster against dominant or emerging variants in the USA, such as omicron BA.5 or XBB, regardless of earlier vaccination or infection history.