YS Biopharma has reported positive interim data from Phase II part of the Phase II/III head-to-head clinical study of its PIKA recombinant Covid-19 vaccine.

The randomised, multiple country, multi-centre, double blinded ongoing Phase II/III study was designed for assessing the immunogenicity, safety, and efficacy of a booster dose of PIKA recombinant protein Covid-19 vaccine (CHO cell, S protein).

It is conducted in the Philippines and United Arab Emirates, in participants aged ≥ 18 years who had previously received two or more inactivated Covid-19 vaccine doses as primary series. 

A total of 300 and 5656 participants were enrolled in the Phase II and III trials, respectively. 

The company stated that the interim data analysis was from the initial 300 participants enrolled in the trial, with each group comprising 150 participants.

According to the findings, the Covid-19 vaccine showed superior immunogenicity and statistical significance, the trial’s primary endpoints, against Omicron virus, as measured by GMT of neutralising antibody on Day 14, compared to inactivated Covid-19 vaccine.

The trial also met its key secondary endpoint of superior immunogenicity of the vaccine, as measured by the seroconversion rate of neutralising antibody against Omicron virus from Day zero to Day 14, compared to inactivated Covid-19 vaccine.

Additionally, the PIKA Covid-19 vaccine showed a safety and reactogenicity profile and there were no significant safety issues identified.

YS Biopharma chief medical officer Dr Zenaida Mojares said: “In this head-to-head study, we are very pleased to observe the multiple folds higher immune responses demonstrated by PIKA Covid-19 vaccine against Omicron virus as measured by GMT levels of neutralising antibody in subjects boosted with PIKA recombinant Covid-19 vaccine as compared to inactivated Covid-19 vaccine based on interim data analysis.

“These results provide more evidence in supporting the high potential of PIKA recombinant Covid-19 vaccine as an effective booster vaccine to address the continuous burden of Covid-19 in many countries and regions where inactivated Covid-19 vaccines were widely administered.”