EuBiologics said on Monday that its Covid-19 vaccine, EuCorVac-19, confirmed safety and efficacy based on phase 3 interim results and plans to apply for marketing authorization in the Philippines this month.

EuCorVac-19 is a recombinant protein vaccine using the company’s proprietary immune boosting platform.

The phase 3 clinical trial was conducted on approximately 2,600 Filipino adults aged 18 years and older to demonstrate superior immunogenicity and non-inferior seroresponse rates using the Oxford-AstraZeneca ChAdOx1 Covid-19 vaccine as the control.

The immunogenicity results confirmed that the formation of neutralizing antibodies to prevent Covid-19 infection was more than two times higher in EuCorVac-19 than in the control vaccine. 

Also, the seroresponse rate, which increased by more than four times after vaccination, was higher in EuCorVac-19, meeting the primary outcome measure of immunogenicity, the company said.

In particular, the neutralizing antibodies and seroresponse rate in the elderly aged 65 years and older were also relatively superior to the control vaccine, showing that EuCorVac-19 can be effectively used in the elderly. 

Regarding the omicron BA.5 variants, another immunogenicity assay also confirmed that EuCorVac-19 produced more than two-fold higher neutralizing antibody titers than the control vaccine.

Safety results showed a slightly lower incidence of predicted adverse events with EuCorVac-19 compared to the control vaccine and no difference in the incidence of unexpected adverse events between the two vaccines. 

Presently, the trial is still being conducted in the Democratic Republic of the Congo and the company plans to apply for marketing authorization in the fourth quarter when the trial is completed.

The company also plans to file an investigation new drug (IND) application for a monovalent vaccine against the current global outbreak of the omicron sub-XBB variant or a bivalent vaccine containing the omicron sub-XBB variant and antigens from the initial Covid-19 virus.

"We are pleased that the first application of our proprietary immune-boosting platform technology, was effective against an internationally licensed control vaccine," said an official from EuBiologics. "We plan to use the same platform to accelerate the development of our respiratory syncytial virus and shingles vaccines which will enter clinical trials later this year."