The number of registrations on the Wuhan pneumonia vaccine subject platform exceeded 5,000 | Life | Key news

(Central News Agency reporter Zhang Minghuan, Taipei, 11). 3 national Wuhan pneumonia vaccine candidates entered phase II clinical trials at the end of the year as soon as possible. The government first went ahead to establish a subject selection platform for industry players. It quickly surpassed 1,000 registrations and surpassed 5,000 at 8pm.

Research and development of the Wuhan domestic pneumonia vaccine (coronavirus disease 2019, COVID-19) is in full swing. The second phase clinical trials of each vaccine factory are expected to accept more than 3,500 people. To avoid the difficulty of recruiting subjects and delay clinical trials, the Epidemic Central Command Center Today, the “COVID-19 Vaccine Clinical Trials Intent Registration Platform” was established to accelerate the industry acceptance rate of vaccines.

This online recruitment is expected to recruit more than 20,000 willing subjects by November 30, and the number is unlimited. (Publisher: Chen Qingfang) 1091111

Wuhan Pneumonia Vaccine Subject Platform Breaks 1,000 Records In Less Than 2 Hours

(Central News Agency reporter Zhang Mingxuan, Chen Weiting, Taipei 11) To accelerate the clinical trial of the Wuhan domestic pneumonia vaccine, the command center established a subject recruitment platform. The number of registrations surpassed 1,000 in less than 2 hours, but the Food and Drug Administration asked for specific diseases. Registration is not recommended for cancer patients who have just had surgery or are in treatment.

In order to prevent clinical trials of Wuhan Domestic Pneumonia (COVID-19) vaccines due to difficulty in recruiting subjects, the Epidemic Central Command Center today announced the establishment of the “Trial Intent Registration Platform COVID-19 Vaccine Clinics “, which is willing to become The public of the subjects can register online and the goal is to recruit more than 20,000 people by November 30. Vaccine clinical trials are expected to accelerate to achieve the goal of domestically produced vaccines for home use as soon as possible.

In response to emergency use needs, the Food and Drug Administration has published Emergency Use Authorization (EUA) guidelines, hoping to increase the number of subjects in phase II clinical trials from hundreds to 3,000 in the past, more than 500 control groups, requiring a total of 3500 people. After passing, you must pass the corresponding security assessment. Once there is an urgent need for use, it can be answered with small-scale mass production.

Zhang Shangchun, the coordinator of the command center expert advisory group, explained that this phase II clinical trial mainly assesses the safety and concentration of antibodies, whether it can neutralize the virus, etc., and refers to the results of tests phase III clinicians to determine how high the antibody level is. To avoid infection, the result of the evaluation will also be used as a reference for the EUA authorization.

However, Zhang Shangchun candidly said that since there is no epidemic of Wuhan pneumonia in China, it is difficult to test the protection of the vaccine in an epidemic setting, and the infection status of subjects compared to placebo is different. . Therefore, the phase III clinical trial can cooperate with other countries. Know the current status of the vaccine.

Since the command center announced the launch of this platform at 2pm, the number of registrants has exceeded 1,000 in less than 2 hours.

The Food and Drug Administration noted that participants must be adults over 20 years old, and minors between 12 and 20 years old must be registered by themselves, but the consent of the legal representative must be obtained; if there is a chronic unstable disease, immunity It is not recommended to register for people with low function or disease of the immune system, major surgery in the last month, cancer treatment or who are trying to conceive, get pregnant or breastfeed women. (Publisher: Chen Renhua) 1091111

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