SKYVaricella Special Precautions

1) The duration of protection against varicella infection after vaccination with SKYVaricella is unknown.
2) Effectiveness of re-vaccination has not been evaluated. The need for booster doses is not defined.
3) As with other vaccines, vaccinations with SKYVaricella does not result in protection of all vaccine recipients.
4) As with other vaccines, anaphylactic/anaphylactoid reaction might occur with SKYVaricella. Adequate treatment provisions, including epinephrine injection (1:1,000) should be available for immediate use.
5) Deferral of vaccination should be considered in acute illness (e.g. fever > 38.0°C)
6) Transmission of the virus has not been reported from SKYVaricella clinical studies. However, it has been confirmed at post-marketing of other varicella virus vaccine that transmission of vaccine virus may occur rarely between healthy vaccinees who develop a varicella-like rash and healthy susceptible contacts and transmission of vaccine virus from vaccinees who do not develop varicella-like rash has also been reported.
Therefore, vaccine recipients should attempt to avoid, whenever possible, close association with susceptible high-risk individuals for up to 6 weeks. In circumstances where contact with high-risk individuals is unavoidable, the potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting wild-type varicella virus. Susceptible high-risk individuals are as follows: Immunocompromised individuals; Pregnant woman without documented history of chickenpox or laboratory evidence of prior infection; Newborn infants of mothers without documented history of chickenpox or laboratory evidences of prior infection.
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed.
Use in Children: Since the safety and efficacy of the vaccine for infants less than 12 months of age has not been established, SKYVaricella is not administered to infants less than 12 months of age.
Use in the Elderly: SKYVaricella is not used in adults including elderly for the prevention of varicella.