SKYZoster™ Shingles Vaccine 2023
SK bioscience SkyZoster (NBP608) is a live-attenuated zoster vaccine developed in South Korea. The vaccine was approved in South Korea by the Ministry of Food and Drug Safety (KMFDS) in September 2017 based on the results of clinical trials conducted in domestic and global institutions.
SK bioscience is growing into a domestic and global vaccine developer by continuously making investments and establishing infrastructure for vaccine development. For further information, please visit https://www.skbioscience.co.kr/en/main.
SkyZoster Availability 2023
SkyZoster is authorized in South Korea, Thailand, and Malaysia. SK bioscience plans to submit SKYZoster™ Pre-Qualification to the WHO to further accelerate the vaccine's approval for overseas emerging markets, such as Southeast Asia and developing countries.
SkyZoster Indication
This live attenuated vaccine is indicated for adults over the age of 50 to prevent Shingles (Herpes Zoster). It is contraindicated for individuals with a history of hypersensitivity reactions to gelatin or any other component in SKYZoster.
SkyZoster Dosage
Sky Zoster is administered as a single dose by subcutaneous injection into the outer aspect of the upper arm as one full dose (approximately 0.5 mL) and should not be injected intravascularly or intramuscularly. Keep refrigerated at 2-8°C in an airtight container away from light.
SkyZoster News 2023
February 28, 2023 - SK Bioscience said its shingles vaccine Skyzoster has taken the top market share position in 2022.
January 9, 2023 - SK bioscience announced that the company has received a biologics license application approval of the 'SKYZoster™' from the National Pharmaceutical Regulatory Agency in Malaysia.
May 20, 2019 - The SkyZoster vaccine study's results found ‘no statistically significant difference between the 2 groups in terms of the geometric mean spot numbers determined by IFN-γ and IL-2 ELISPOT assays at 6 weeks post-vaccination.’
October 9, 2017 - South Korean drug regulators granted approval to SK Chemicals’ Zoster vaccine.
SkyZoster Clinical Trials
Clinical Trial NCT03120364: Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adults Aged 50 and Over: This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme-Linked Immunosorbent Assay). A total of 824 healthy subjects (412 subjects per treatment arm) aged 50 and over are enrolled, and each subject is administered with a single dose of vaccine which is randomly assigned.
This is a multi-center, randomized, double-blinded, parallel-group study to assess the Immunogenicity and safety of NBP608 compared to Zostavax which are indicated for the prevention of herpes zoster. Total of 824 healthy subjects aged 50 and over are enrolled, and each subject is administered with a single dose of vaccine which is randomly assigned in 1:1 ratio. Stratified randomization for the age group is used to achieve the balance of treatment assignment within age strata.
A total of five visits are scheduled, including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 2 and Visit 4 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through Visit 3*, Visit 4 and Visit 5* (* telephone contact).