Pharmaceutical Business review

US FDA approves Valneva’s vaccine against chikungunya virus

IXCHIQ is a live-attenuated vaccine in the US indicated to prevent the mosquito-borne disease. Credit: Егор Камелев on Unsplash.

Claimed to be the first vaccine against the disease to receive FDA’s marketing approval, IXCHIQ uses Albumedix’ Recombumin.

Recombumin is an animal origin-free recombinant human albumin and is included as an excipient in the final formulation of the vaccine.

Acting as a logistical enabler, it supports the vaccine’s stability and confers storage and logistical benefits, thereby supporting its distribution across the globe.

Albumedix’ CEO Jonas Skjødt Møller said: “Recombumin is a multifunctional tool for the life sciences, refined through 40 years of research and development it builds upon the natural qualities of human albumin.

“In this application, as an excipient in the final formulation, Recombumin benefits the logistics associated with the product.

“The expansion in the number of approved vaccines and biopharmaceuticals using Recombumin is a testament to the safety and quality of the product we produce.”

Recombumin is a multifunctional excipient, ancillary, and raw material and is used in various pre-clinical, clinical, and marketed vaccines and biopharmaceuticals. It is produced in cGMP facilities in the UK from a proprietary yeast strain.

IXCHIQ is a live-attenuated vaccine in the US indicated to prevent the mosquito-borne disease in individuals aged 18 years and above at increased risk of exposure to the virus.