18 October 2021 | News
Provides data to support MVC-COV1901 for entering phase 3 efficacy trials
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Taiwan-based Medigen Vaccine Biologics Corporation has recently stated that MVC-COV1901, a recombinant protein vaccine containing pre-fusion-stabilised spike protein S-2P adjuvanted with CpG 1018 and aluminium hydroxide, has been shown to be well tolerated with a good safety profile in healthy adults aged 20–49 years in a phase 1 trial, and provided a good cellular and humoral immune responses.
The company has presented the interim safety, tolerability, and immunogenicity results of a phase 2 clinical trial of the MVC-COV1901 vaccine in Taiwan.
Medigen has reported the results of the interim analysis of the phase 2 clinical trial of MVC-COV1901 (15 µg S-2P protein); the first large-scale trial to evaluate the safety and immunogenicity profiles of MVC-COV1901 in 3844 adults aged 20 years and older.
MVC-COV1901 was shown to have a good safety and immunogenicity profile. The current data support MVC-COV1901 to enter phase 3 efficacy trials, and could enable regulatory considerations for emergency use authorisation (EUA) in different countries, as has been done in Taiwan.
By sharing the phase 2 clinical data and the proposed correlates of protection methods with other COVID-19 vaccine developers in the community, Medigen hopes to expedite the development and approval of more COVID-19 vaccine candidates to increase global supply, and to thereby help the countries and regions most in need.