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On June 10, according to Taiwanese media reports, a meeting of IDMC's Independent Data Monitoring Committee, composed of independent scientific experts in Taiwan, was held at 1 p.
The new crown pneumonia immunization vaccine group after-administration of the second agent seroconversion rates (seroconversion rate) 28 days was 99.
S-2P antigen is combined with aluminum salt and CpG1018 adjuvant to make a finished vaccine
FDA
According to the guidelines announced by the FDA on Friday, the neutralizing antibody efficacy level of the new crown vaccine must be equal to or higher than the efficacy level of the AstraZeneca COVID-19 vaccine before it can be considered for EUA
However, since Taiwan’s candidate vaccines have not yet started a larger phase III trial, this is usually the criterion for determining efficacy-the FDA will allow the analysis of phase II results through immune bridging, which uses the immune response measured by clinical trial participants to infer The overall level of protection of the vaccine
According to the FDA, the analysis must be based on serum neutralizing antibody samples taken 28 days after more than 3,000 participants in a phase II clinical trial received the second dose of the vaccine
To obtain the EUA, the trial data of the high-end vaccine must be compared with the neutralizing antibody efficacy levels found in a control group of 200 AstraZeneca vaccinators at Taoyuan Hospital, and a decision will be made as early as July
Taiwan has signed a contract to purchase 5 million doses of high-end vaccines and another 5 million doses from United Biomedical Inc.
Taiwan began to launch its first dose of COVID-19 vaccine purchased on March 22.
Reference material: https://focustaiwan.
https://focustaiwan.
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