High-end martial arts vaccination subjects paid 10,000 yuan? The truth of the “Apple” investigation is published | Apple News | Apple Daily

To accelerate the research and development of the national Wuhan pneumonia vaccine, the Food and Drug Administration announced yesterday (11/11) the “COVID-19 vaccine clinical trial intent registration platform”, which enables people to sign up online to participate in vaccine clinical trials on a voluntary basis. However, some readers reported to “Apple News”. The complaint concerns someone who posted information about the second phase of the high-end Wufei vaccine trial on Facebook last week, stating that you can register as long as you meet the requirements. The fee for the trial is more than 10,000 yuan, but the high-end refuted it and did not publish this information. The first phase of the clinical trial has not yet started the second phase, nor will it recruit or contact subjects through the Internet platform.

Three domestic high-end Guoguang and Uniasia Biotech manufacturers have invested in the research and development of Wufei vaccines. They are currently in the first phase of clinical trials. To reduce the window period of the first and second clinical trials, the Food and Drug Administration established the “COVID-19 Vaccine Clinical Trial Intentions Registry Platform”, for the first time, the central government recruited subjects from clinical trials. It was announced that in just one day, thousands of volunteer citizens registered online.

However, some readers complained to “Apple”. A few days ago, it was discovered that some people had posted on their personal Facebook, claiming that they were recruiting subjects for the second phase of clinical trials of high-end martial arts vaccines. They were able to participate because they knew people related to the National Taiwan University Hospital. Vaccine research and development projects, as long as they meet the conditions of 12 years of age or older, without significant disability and a BMI value below 40, and provide their name, date of birth and mobile phone, etc. , can enroll in the second phase of the high-level trial and report the information to the hospital. The remuneration for the trial is about 10,000 yuan, which also makes readers wonder if this is illegal.

However, high-level clarification, there is absolutely no such issue. I have actively contacted the publication public, but have not received a response, emphasizing that the current clinical trial is still in the first phase. If it is to enter the second phase, it must be approved by the Food and Drug Administration of the Ministry of Health and Welfare. Subjects are recruited, and they never actively recruit and contact subjects, and they never publish information about subject recruitment over the Internet. At present, they have not negotiated with the National Taiwan University Hospital on the plan and method for conducting the second trial.

As for the amount of subsidies that people who participate in the second phase of clinical trials can receive in the future, Gao said he is currently unable to disclose. If they are willing to participate in the future, the clinical trial nurses will report the corresponding expenses. Manufacturers cannot disclose expenses to the public to avoid a violation of ethics.

Pan Xiangying, Jian Ren and the technical staff of the Food and Drug Administration Drug Group said that the Phase II clinical trial of high-end vaccines has not yet been approved. If the recruitment of Phase II subjects is to be initiated, the “Principles of Recruitment of Clinical Trial Subjects” must be adhered to and clearly stated. It is clear that the test unit and subjects must cooperate with the information and recruitment channels, and must obtain the approval of the ethical review board (IRB). Failure to comply with the regulations will violate Medical Law.

Pan Xiangying pointed out that the subjects recruited by the testing institutions and vaccine factories will send a message to ask whether the National Taiwan University Hospital and the high-end have this matter. If confirmed as personal behavior, it does not fall within the jurisdiction of the department, and the high-end or experimental unit will. Evaluate whether to adopt the relevant legal measures.

When “Apple” rechecked the individual Facebook page, it was discovered that the recruitment article had been removed yesterday. (Xu Zhijia / Taipei Report)