SKYVaricella Injection Adverse Reactions

Safety of SKYVaricella Inj. was evaluated in 365 subjects aged 12 months to 12 years and 167 subjects (45.75%) experienced adverse drug reactions.
Local reaction: Injection site pain/tenderness, erythema/redness, and induration/swelling may occur.
Systemic reaction: Fever, whining/irritability, somnolence/exhausted and occasionally systemic reaction such as fatigue/malaise and headache may occur after vaccination.
Solicited adverse drug reactions^† (local and systemic reactions) after vaccination of SKYVaricella Inj. are summarized in following table. (See Table 2.)

Click on icon to see table/diagram/image

Unsolicited adverse drug reactions were reported in 16 (4.38%) out of 365 subjects aged 12 months to 12 years during 42 days post-vaccination of SKYVaricella Inj. The most frequently reported unsolicited adverse drug reaction was skin and subcutaneous tissue disorders with 7 subjects (1.92%) reporting 8 cases and followed by infections and infestations with 6 subjects (1.64%) reporting 6 cases. With regard to the outcomes of adverse drug reactions, all subjects were recovered without sequelae. Adverse drug reactions occasionally observed (≥0.1 and <5%) are shown as follows: Gastrointestinal disorders: Vomiting, diarrhea.
Infections and Infestations: Gastroenteritis, nasopharyngitis, upper respiratory tract infection.
General disorders and administration site conditions: Vaccination site erythema.
Metabolism and nutrition disorder: Decreased appetite.
Skin and subcutaneous tissue disorders: Erythema, rash, rash vesicular.
7 serious adverse events occurred within 26 weeks post-vaccination in 6 subjects (1.64%) out of 365 subjects (2 cases of bronchiolitis, 1 case of otitis media acute, 1 case of pneumonia, 1 case of upper respiratory tract infection, 1 case of pneumonia respiratory syncytial viral, and 1 case of thermal burn). All of these serious adverse events were confirmed to be not related to SKYVaricella Inj., which were reported in phase III clinical trial.
Varicella-like rashes were reported in 6 subjects (1.64%) out of 365 subjects with 6 cases within 42 days post-vaccination, which were reported in phase III clinical trial. Among the cases of varicella-like rash occurred within 42 days post-vaccination in the phase III clinical trial, 5 cases in 5 subjects were generalized varicella-like rashes and 1 case in 1 subject was injection-site varicella-like rash. In regard to 4 cases of generalized varicella-like rash and 1 case of injection-site varicella-like rash, samples from the lesion of subjects were collected and polymerase chain reaction (PCR) assay was conducted. As a result, varicella-zoster virus was identified in 5 cases, but the virus type (wild type or Oka/SK strain) could not be specified. 2 cases of generalized varicella-like rashes were confirmed to be not related to SKYVaricella Inj. and it was determined that a causal relationship between 3 cases of generalized varicella-like rashes and 1 case of injection-site varicella-like rash and SKYVaricella Inj. could not be ruled out.
Post-marketing surveillance in South Korea: During 4-year post-marketing surveillance (PMS) among 623 subjects for re-examination, incidence rate of adverse events was reported by 42.22% (263/623 subjects, 514 cases) regardless of the causal relationship with SKYVaricella Inj. Serious adverse drug reactions and unexpected adverse drug reactions of which causal relationship with SKYVaricella Inj could not be ruled out are shown in following table according to its incidence frequency. (See Table 3.)

Click on icon to see table/diagram/image