SKYVaricella Adverse Reactions

Clinical trial data: 1) Safety of SKYVaricella was evaluated in 365 subjects aged 12 months to 12 years and 167 subjects (45.75%) experienced adverse drug reactions.
2) Local reaction: Injection site pain/tenderness, erythema/redness, and induration/swelling may occur.
3) Systemic reaction: Fever, irritability, somnolence 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 are summarized in table as follows. Frequencies are reported as: Very common (≥1/10) /Common (≥1/100 to <1/10) /Uncommon (≥1/1,000 to <1/100) /Rare (≥1/10,000 to <1/1,000) /Very rare (<1/10,000). (See Tables 2 and 3.)

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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. 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. (See Tables 4 and 5.)

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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, 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, 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 could not be ruled out.