Third Country Approves Innovative Shingles Vaccine
SK bioscience today announced that it received a biologics license application approval for the 'SKYZoster™' shingles vaccine from the National Pharmaceutical Regulatory Agency in Malaysia.
SKYZoster is a live vaccine that attenuates the varicella-zoster virus and was initially approved in South Korea in 2017, then in Thailand in May 2020.
A recent Phase III clinical trial showed that SKYZoster is non-inferior compared to the control vaccine (Zostavax).
The cell-mediated immune response was also shown to be at an equal level, proving SKYZoster™ effectively induces immunogenicity against shingles, also known as herpes zoster.
Jaeyong Ahn, CEO of SK bioscience, commented in a press release on January 9, 2023, "It is encouraging that vaccines made by our technology are gradually expanding their influence in the global vaccine market where big pharmaceutical companies mainly dominate."
SKYZoster™ is steadily expanding its market position in South Korea. According to the IMS data, SKYZoster's market share in the third quarter of 2022 reached 56%.
Additionally, SK bioscience plans to submit for SKYZoster Pre-Qualification to the World Health Organization.
Shingles is a vaccine-preventable disease, says the U.S. Centers for Disease Control and Prevention (CDC).
About 33% of people in the U.S. will develop shingles in their lifetime.
If you've ever had chickenpox, you can get shingles. Even children can get shingles. And your risk of shingles increases with age says the CDC.
In the U.S., the Shingrix® vaccine is the market leader and is generally available at most clinics and pharmacies.
Other approved shingles vaccines and vaccine candidate news are posted at PrecisionVaccinations.com/Shingles.