Cellid finishes phase 3 dosing of Omicron-targeted Covid-19 vaccine

Cellid said Wednesday that it has completed recruiting and dosing all subjects in its phase 3 clinical trial of AdCLD-CoV19-1 OMI, a Covid-19 vaccine targeting the Omicron variant.

The company added that the phase 3 trial was conducted in Korea, the Philippines, and Vietnam and involved 4,000 adults 19 and older who had completed their last dose of a Covid-19 vaccine or were at least 16 weeks out of isolation from Covid-19.

Cellid will analyze safety and immunogenicity data in week four after all subjects have been dosed.

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Based on these results, an interim analysis will be conducted, and a conditional marketing authorization application will be filed. In addition, Cellid will develop new variant-specific vaccines in response to the WHO and national recommendations to meet the review timeline and pursue national supply through an Emergency Use Authorization (EUA).

Earlier this month, Cellid announced that it had finalized the phase 1/2 top-line results report for its Omicron vaccine. The phase 2 results showed that neutralizing antibodies remained stable 52 weeks after administration, confirming long-term immunity and demonstrating safety with no serious adverse events.

“We are very pleased to have completed the dosing of 4,000 subjects in phase 3 and look forward to conducting the interim analysis based on the week four data,” Cellid CEO Kang Chang-yuil said. “We expect positive results in this study as we have seen the vaccine's long-term immune effectiveness and safety in phase 1."

Kang noted that Covid-19 continues to pose a high threat to high-risk populations, and the government strongly recommends vaccination.

“We are committed to successfully launching our proprietary vaccine and securing vaccine sovereignty. Furthermore, we will continue to research and develop to become a global bio company to respond to future pandemics,” he added.