What's Happening?
SK bioscience has submitted an Investigational New Drug (IND) application for a Phase 3 clinical trial of its SKYVaricella vaccine. This trial aims to evaluate a 2-dose regimen, aligning with international standards that recommend two doses for stronger immunity against varicella. The trial will involve approximately 800 children aged 12 months to 12 years, with completion targeted by 2027. The move reflects a shift in global vaccination strategies, as countries like the United States have already adopted a 2-dose schedule.
Why It's Important?
The submission of the IND for a 2-dose varicella vaccine by SK bioscience is significant in the context of global public health. The adoption of a 2-dose regimen is expected to enhance immunity and reduce the incidence of varicella, aligning with recommendations from health authorities like WHO. This development could influence vaccine policies worldwide and drive market growth, projected to reach USD 6.3 billion by 2034. SK bioscience's strategic move positions it to compete in the expanding global vaccine market.
What's Next?
The Phase 3 trial will assess the immunogenicity and safety of the 2-dose regimen, with results expected by 2027. Successful completion could lead to broader adoption of the vaccine in international markets. SK bioscience plans to leverage its WHO PQ certification and existing supply agreements to expand its market presence. The outcome of this trial could also prompt other vaccine manufacturers to adopt similar strategies, potentially reshaping the global vaccine landscape.
