Walvax Biotech Wins Jordan FDA Approval for 13‑Valent Pneumococcal Vaccine

Walvax Biotech Wins Jordan FDA Approval for 13‑Valent Pneumococcal Vaccine

China‑based Walvax Biotechnology Co., Ltd. (SHE: 300142) has secured market approval from the Jordan Food & Drug Administration for its 13‑valent pneumococcal polysaccharide conjugate vaccine (PCV‑13). The decision expands the company’s footprint in the Middle East and reinforces its position as a leading developer of pediatric immunizations.

Product Profile
Walvax’s PCV‑13 protects infants and young children aged 6 weeks to 5 years against 13 invasive pneumococcal serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. The vaccine, first approved in China in 2020, has demonstrated robust immunogenicity and a favorable safety profile in clinical studies, making it a key tool in reducing childhood pneumonia and invasive disease burden.

Regulatory Milestone and Market Outlook
The Jordan FDA’s approval marks a significant regulatory milestone that could open access to a sizable market of over 8 million children. With local distribution agreements in place, Walvax plans to roll out the vaccine within the next 12 months, targeting both public health programs and private pediatric practices.

Conclusion
Walvax’s entry into the Jordanian market underscores the growing global demand for high‑valency pneumococcal vaccines. By extending its reach beyond China, the company positions itself to capture a share of the expanding pediatric vaccine market in the region.-Fineline Info & Tech