P227: Immuno-bridging in the Evaluation of Novel COVID-19 Vaccine EUA in Asia: A Regulatory Perspective and Experience Sharing

Poster Presenter

Ting-Ya Chang

Section Chief
TFDA/Center for Drug Evaluation
Taiwan

Objectives

Suffering from the outbreak and global vaccine shortage, Taiwan FDA designed an immuno-bridging study to demonstrate the non-inferiority between a novel COVID-19 vaccine and ChAdOx1 nCoV-19a, and approved emergency use for MVC-COV1901 in Jul, 2021.

Method

Regarding a possible outbreak and global vaccine shortage, Minister of Health and Welfare (MOHW) and Taiwan Food and Drug Administration (TFDA) planned the TYGH-AZ trial as an immuno-bridging study to demonstrate the non-inferiority between a novel COVID-19 vaccine, MVC-COV1901 and ChAdOx1 nCoV-19.

Results

This study was started on 22 March 2021, the first day of ChAdOx1 nCoV-19 vaccination campaign in Taiwan, and proceeded simultaneously with MVC-COV1901’s trial (Study CT-COV-21, NCT04695652). The comparison is defined by the co-primary endpoint of humoral immune response and set as two success criteria: (1) the lower bound of the 95% confidence interval should be above 0.67 for geometric mean titer (GMT) ratio, and (2) the lower bound of the 95% confidence interval above 50% for sero-response rate (SRR). The GMT ratio against live wild-type SARS-CoV-2 of MVC-COV1901 subjects is four-fold higher, and with over 96% SRR when compare with ChAdOx1 nCoV-19 cohort, respectively.

Conclusion

Based on the safety data collected from over 3,000 MVC-COV1901 subjects, no SAE were observed. From regulatory perspective, both co-primary endpoint results meet the success criteria with no major safety concerns has demonstrate the major evidence to support the emergent use authorization under high unmet medical need. Thus, TFDA had approved emergency use for the novel COVID-19 vaccine, MVC-COV1901, in responding to the outbreak in May, 2021.