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On the morning of December 30, the team tested Covid-19 vaccine The Military Medical Academy has administered the Covid-19 Nano Covax vaccine to 7 testers at a dose of 50 mcg. According to Dr. Chu Van Men, director of the Center for Clinical Trials and Bioequivalence (Military Medical Academy), 20 people who previously injected a test at a dose of 25 mcg had mild fever symptoms of 37.1 to 37.2 degrees C, the highest is 37.8 degrees. About 50% -75% of the people who injected themselves in the injection test showed a mild fever. Some people tested had mild pain in the biceps where the vaccine was administered. The rest of the testers were completely normal.
In some cases, after the test injection of the Covid-19 vaccine, there was fever and pain at the injection site.
According to Dr. Chu Van Men, most of the volunteers who participated in the Covid-19 vaccine trial showed all the symptoms of these side effects after 1 day and did not require medical intervention. Currently, the people receiving the test injections are in stable health and in a comfortable mood. These side effects after vaccination are all in the estimates of scientists.
Information from the research team also said that after completing 2 doses of Covid-19 Nano Covax 25 and 50 mcg vaccines, so far the 75 mcg dose is awaiting approval from the Ministry of Health before the test injection. in body. At a dose of 50 mcg, 11 injections were given to 11 volunteers. Some people, including the 72-hour follow-up period at the medical center, returned home for a follow-up medical check-up under the supervision of local health workers.
According to Lieutenant General Do Quyet, director of the Military Medical Academy, there are 10 specialized teams between emergencies, vaccination security, pharmacy … to be prepared to respond to all possible situations during the test.
On behalf of the Nanogen Company, which researches and manufactures the Nano Covax vaccine, experimental vaccination may have certain potential risks. The reaction after the injection may be a red halo, swelling, plaque, or infection at the injection site. Additionally, the person receiving the injection may also experience a fever, muscle aches, or nausea. Although in most cases, volunteers will experience only mild side effects, but there may be a small chance of having a severe allergy to the vaccine.
Before that, Cong Nanogen signed a contract with an insurance company to cover risk situations during the clinical trial of the Covid-19 vaccine.
The Health Ministry said that during the first phase of the Nano Covax vaccine trial, the Military Medical Academy will select 60 volunteers between the ages of 18 and 50. Volunteers will be randomly assigned to 3 groups. First, group 1A will be recruited with 20 users at a dose of 25 mcg / injection. Group 1B consisted of 20 users at a dose of 50 mcg. Group 1C consisted of 20 users with a dose of 75 mcg. Participants in the phase 1 study will receive 2 intramuscular injections of the vaccine, the interval of which is 28 days. To ensure the safety of study participants, during the recruitment period of 60 participants, safety assessment according to the increasing dose detection design.
The enrollment process for Phase 1 participants will begin with three people in the 25 mcg dose group. Based on the results of the follow-up and evaluation of 72 hours after vaccination in the first 3 people, it is necessary to decide the dose level and the number of next participants. The duration of the study per participant was approximately 56 days for the evaluation of the study objective and the follow-up until the sixth month from the first injection.
D.Thu
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