Taiwan’s domestic vaccine phase II unblinding success will apply for emergency authorization EUA

Taiwan’s vaccine company high-end research and development of COVID-19 vaccine, held a phase II clinical trial unblinding press conference today to announce the phase II clinical data, the results show that the vaccine seropositive transfer rate of up to 99.8%, the company stressed that the safety is good, all subjects did not appear vaccine-related serious adverse reactions.

The high-end New Crown Pneumonia vaccine will become the first local vaccine company to successfully launch the vaccine in Taiwan, and is also a part of Taiwan’s domestic independent vaccine strategy, which has indicator significance.

The immunogenicity assessment of the vaccine includes seroconversion rate, neutralizing antibody geometric mean potency (GMT titer), and GMT ratio. Seroconversion rate is an important indicator of the success of the vaccine in inducing immune memory against the virus after administration.

In the immunogenicity section, the seroconversion rate at 28 days after the second dose was 99.8% in the vaccine group, regardless of age group, while the seroconversion rate was 99.9% in the vaccine group aged 20-64 years, the geometric mean potency of neutralizing antibodies (GMT titer) was 733, and the GMT ratio was 180-fold The increase.

The Phase II main clinical trial began with the first dose of vaccine in the first subject on January 22 and completed with the second dose in all subjects on April 28, with a total of 4,000 doses administered.

The S-2P antigen platform was transferred from the US National Institutes of Health.

Gao Tuan said that the analysis report and R&D related documents will be sent to FDA for EUA emergency authorization review as soon as possible, and will consult with EMA and other international drug certification authorities to apply for Phase III clinical trials.

The Phase II clinical trial is ongoing, and according to the trial plan, subjects will continue to be followed for six months.

In addition to the Phase II main trial, there are still several clinical evaluations underway, which will continue according to the plan, including an extension trial with a third additional dose of vaccine for Phase I subjects to test the safety and immunogenicity of the third additional dose, and a high-dose comparative trial for the elderly population to test safety and immunogenicity.