TAIPEI (Taiwan News) — Taiwan’s United Biomedical, Inc. (UBI) on Sunday (June 27) released the midterm study report for the phase II clinical trials of its COVID-19 vaccine UB-612, claiming it showed strong performances in terms of safety and efficacy, with no trial participants experiencing serious adverse reactions, CNA reported.
The company plans to submit the midterm report to the Taiwan Food and Drug Administration (FDA) at the end of June for emergency use authorization (EUA) of the UB-612 vaccine.
Regarding immunogenicity, the midterm report said that the vaccine has a 95.65 percent seroconversion rate and a GMT titer of 102.3 for participants aged 18 to 64 after receiving the second dose. The seroconversion rate means the percentage of people whose bodies have developed specific antibodies in their blood serum as a result of infection or immunization.
However, experts said the GMT titer of 102.3 is low compared to the COVID-19 vaccine being developed by another Taiwanese company, Medigen Vaccine Biologics Corporation (MVC), which has a GMT titer of 662. According to experts, a GMT titer range between 600 and 700 is a good result.
UBI plans to complete phase II trial in the second half of November, while it will also speed up phase III clinical trial involving 11,000 participants in India, according to CNA.
UBI is developing the world's first multitope peptide-based vaccine (MPV) against SARS-CoV-2. According to a UBI press release, UB-612 does not require ultra-low temperatures for its transportation and storage, which will help it maintain a competitive edge over mRNA vaccines developed by Pfizer-BioNTech and other companies.
