4.1. CoviVac Safety in Phases I/II and IIb
asthenia, fatigue, pain, deaths, chills
ADVERSE EVENTS
Overall, in phases I/II starting from 3 October 2020, 498 volunteers were screened for eligibility at three clinical sites, and 400 volunteers aged 18–60 years were enrolled in the study. All participants were randomized into two groups: 300 participants were assigned to receive the vaccine and 100 participants were assigned to receive a placebo (two injections, 0.5 mL, 14 day intervals for both the vaccine and placebo).The studied vaccine has shown good tolerability and safety. No deaths, serious adverse events, or other significant AEs related to vaccination have been reported. The most common AE in the Vaccine Group was pain at the injection site. It was registered in the Placebo Group as well but was significantly less common (The phase IIb study randomized 200 volunteers aged 60 years and older (mean age 67.26 ± 6.29 years). Of these, 199 volunteers received the CoviVac vaccine three times with an interval of 21 days. In total, 165 (82.5%) volunteers completed the study according to the Protocol.In the 60+ age cohort, participants were monitored for AEs until Day 21 after the third vaccination. The studied vaccine has shown good tolerability and safety. No deaths, serious AEs or other AEs that were considered of special concern due to their clinical significance were reported. The most frequent AEs reported by volunteers were similar to the ones reported by the participants of the phase I/II study: 32.3% of cases were systemic reactions (mild asthenia, chills or fatigue) and pain at the vaccine injection site, which resolved within 3 days after vaccination in 85% of cases.Therefore, overall, 497 clinical trial participants were vaccinated with CoviVac and included in the safety assessment. No serious adverse events or other significant AEs related to vaccination have been reported. The facts show a good safety profile of the CoviVac vaccine. The vaccine can be used for vaccination of adults over 18 years of age. We can anticipate the detection of some extremely rare AEs during the wide use of the vaccine, although the long-term history of use of other inactivated vaccines has proven their exceptional safety.