Safety profile of the varicella vaccine (Oka vaccine strain) based on reported cases from 2005 to 2015 in Japan. Issue 41 (22nd September 2016)

• Record Type: Journal Article
• Authors: Yoshikawa, Tetsushi; Ando, Yuko; Nakagawa, Takafumi; Gomi, Yasuyuki
• Is Part Of: Vaccine. Volume 34:Issue 41(2016)
• Page Start: 4943
• Page End: 4947
• Publication Date: 2016-09-22
• Subjects: Varicella -- Vaccine -- Safety -- Adverse event; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2016.08.044
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: Reports of adverse events associated with Oka/Biken varicella vaccination between 2005 and 2015 were reviewed. There were 88 reports (0.93/100, 000 doses) of varicella-like and 66 reports (0.70/100, 000 doses) of zoster-like skin rashes. The wild-type strain induced varicella-like skin rashes earlier than the Oka vaccine strain. The Oka vaccine strain induced zoster-like skin rashes in younger patients compared to the wild-type strain. Abstract: Background: As of 2014, routine vaccination strategies in Japan have included the varicella vaccine. Given the widespread use of the vaccine, it is important to investigate the safety profile of the vaccine strain, Oka/Biken varicella, in Japanese patients. Methods: Reports of adverse events associated with varicella vaccination between 2005 and 2015 were retrospectively reviewed. Virological analysis was performed on clinical specimens collected from some of the reported cases to determine whether the etiological agent was the wild-type or Oka vaccine–strains. Results: There were 351 reports (3.71/100, 000 doses) of adverse events during the observation period. Among the 351 reports, there were 88 reports (0.93/100, 000 doses) of varicella-like and 66 reports (0.70/100, 000 doses) of zoster-like skin rashes. The wild-type strain induced varicella-like skin rashes earlier than the Oka vaccine strain. The Oka vaccine strain induced zoster-like skin rashes in younger patients compared to the wild-type strain. The onset of zoster-like skin rashes after vaccination was earlier in patients vaccinated with the Oka vaccine–type strain. Conclusion: The Oka/Biken vaccine is generally safe and well tolerated in Japan. Clinical aspects of adverse reactions caused by the Oka vaccine strain were consistent with previous reports from the United States and Europe.