EuBiologics said it will prematurely terminate the phase 3 clinical trials of EuCorVac-19, its Covid-19 vaccine.

In January 2022, EuBiologics had received approval from the Ministry of Food and Drug Safety for the phase 3 trial plan of the vaccine.

However, the company decided to end the trial due to difficulties in recruiting unvaccinated or uninfected participants and securing a control vaccine.

Still, the company said while the clinical trials targeting the original Wuhan strain are being discontinued, the clinical and approval data can be applied to the Covid-19 XBB.1.5 variant vaccine, which is being developed using the same platform.

EuBiologics completed a one-year follow-up period of its phase 3 clinical trial into EuCorVac-19, a Covid-19 vaccine, in the Philippines.
EuBiologics completed a one-year follow-up period of its phase 3 clinical trial into EuCorVac-19, a Covid-19 vaccine, in the Philippines.

EuBiologics also said it has completed the follow up of the phase 3 clinical trial, conducted in the Philippines and the Democratic Republic of Congo,  which compared EuCorVac-19 with existing vaccines to evaluate safety and immunogenicity.

In June last year, EuBiologics released interim results on the safety and immune response following two doses of EuCorVac-19.

With the one-year observation period now concluded, the company anticipates receiving the final clinical study report (CSR) by the end of the second quarter. Given that no significant adverse effects were reported following the interim results, the company has high expectations for the successful completion of the phase 3 trials.

According to the company, the development of EuCorVac-19, initially targeting the original Wuhan strain of the virus, has broader implications.

The company is utilizing the same platform to develop variant-specific boosters, including one for the current XBB1.5 strain, and believes that these developments could be instrumental in securing domestic approval for EuCorVac-19 based on comparative immunogenicity studies with internationally approved variant vaccines.

Plans are in place to apply for domestic clinical trials for the XBB1.5-targeting vaccine in the first half of the year.

"We will continue to develop vaccines and combination vaccines necessary for the ongoing fight against Covid-19 variants, contributing to the domestic self-sufficiency in vaccine supply," a company official said. 

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