TÍNH AN TOÀN CỦA VẮC XIN NANOCOVAX PHÒNG COVID-19 TRÊN NGƯỜI VIỆT NAM TÌNH NGUYỆN

Abstract

Objective: Evaluate the Safety of Nanocovax 25mcg vaccine Vaccine Against COVID-19 produced by Nanogen in Vietnamese volunteers. Methods: Using The phase 1,2,3 vaccine clinical trials were conducted on healthy volunteers, aged 18 years and older who received either the study vaccine or a placebo according to a 2-dose regimen, 28 days apart. Safety is assessed with the evaluation time is 60 minutes, 7 consecutive days and 28 days after vaccine administration. Result: Conducted on 13,266 subjects (9,043 study vaccine and 4,223 placebo). Events appeared in the vaccine group and placebo group after injections at the following times: 60 minutes after injection: local pain (2,43% - 2,72% và 1,36% - 1,06%); 7 days after injection, local pain (35,7% - 20,79% và 37,3% - 21,27%), systemic AE was muscle pain (20,50% - 10,80% và 22,77% - 11,19%). There were 136 SAEs related to any research products, accounting for 1.02%. There were no deaths due to injection of the study product. Conclusion: Nanocovax 25mcg vaccine meets safety requirements in volunteers. The majority of expected and unexpected AEs were mild, did not require medical treatment and recovered completely. The expected AE rate is similar to that of other available Covid-19 vaccines.