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According to experts, those selected for the COVID-19 vaccine trial are selected with great care. They are healthy volunteers with no history of disease, no medical history.
When sharing about the trial roadmap for the COVID-19 vaccine, according to the representative of the Ministry of Health, the vaccines to be tested in humans must meet the following criteria: safety, immunogenicity and especially effectiveness. protection of animals …, these criteria will be evaluated by experts, national and foreign organizations.
The representative of the Ministry of Health stated that the Ethics Council of the Ministry of Health will carefully consider and decide to allow important steps in the testing of human vaccines.
According to experts, those selected for the COVID-19 vaccine trial are selected with great care. They are healthy volunteers with no history of disease, no medical history. These individuals are carefully exploited for health history, allergy (to drugs, food …) because this local factor is strongly related to the reaction after vaccination.
Like drugs, vaccines can cause unwanted reactions, said a medical expert. Meanwhile, in the country, the COVID-19 vaccine has never been injected into humans, so there is no data to compare, so human vaccine tests must be prepared and performed very rigorously.
“International evaluations show that the COVID-19 vaccine is ” healthy ” and safe in nature. The COVID-19 vaccine manufactured in Vietnam was evaluated in animals for safety, but before transfer. For clinical research, the production unit must guarantee strict conditions to guarantee the first human trial, ” he said.
According to Dr. Do Minh Si – Director of Research and Development, Joint Stock Company of Nanogen Biotechnology Joint Stock Company, the most difficult step is the preclinical test step to test the immune response in animals. The immune responses of animals are just one of the criteria for human vaccine testing.
Mr. Nguyen Ngo Quang – Deputy Director of the Department of Science and Training, Ministry of Health, said: “Based on the complete preclinical results, the Council of Ethics in Biomedical Research of the Ministry of Health. The practice will consider all aspects , including those related to the design of the scheme, the protection of the integrity of the research subjects, the condition of the research institution and the options for them. These are very strict requirements, especially to be reviewed, evaluated and reported by the Ethics Committee in Biomedical Research of the Ministry of Health in the evaluation process. By “.
The Military Medicine Academy will be the place to recruit volunteers beginning December 10, after which test injections will be performed. An estimated 20 healthy volunteers will receive the first COVID-19 test injections.
First a small group of about 1-2 people will be vaccinated and reactions will be monitored for 24 to 72 hours, then you will start injecting the next volunteers (about 18-19). After 3 months of testing in a small group, COVID-19 will be tested on approximately 400 people.
According to the Military Medical Academy, the clinical testing unit is now ready with test teams, preparing beds after the injection for volunteers, emergency doctors to monitor health in the first hours after the injection and Can be treated immediately if there are reactions undesirable to the person vaccinating the test vaccine.
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