VALNEVA: FDA Approval of Accelerated IXIARO Vaccination Schedule

Valneva SE (“Valneva” or “the Company”), a commercial stage biotech company focused on developing innovative lifesaving vaccines, announced today that the U.S. Food and Drug Administration (FDA) has approved an alternate IXIARO immunization schedule of two doses administered seven days apart for adult travelers aged 18-65 years old. This accelerated schedule comes in addition to the previously approved schedule.

IXIARO is the only Japanese encephalitis (JE) vaccine licensed and available in the United States (U.S.). The vaccine was approved with a two-dose primary immunization with the two vaccinations administered 28 days apart. The newly-approved accelerated vaccination schedule allows rapid immunization in adults with the two doses given seven days apart. This rapid schedule has already been approved and is used in Europe and Canada.

Franck Grimaud, Valneva`s Chief Business Officer, commented, “Many people make their travel plans at the last minute, so being able to receive IXIARO`s two shots within seven days makes it easier for travelers, ultimately enhancing the value proposition of our product. The U.S. is IXIARO`s largest market and we expect that this new schedule will encourage more U.S. travelers to seek prevention against this devastating disease.”

The FDA`s revised schedule follows previous approvals by Health Canada and the European Medicines Agency, who authorized accelerated IXIARO vaccination schedules for adult travelers in March 2018 and April 2015, respectively.

https://www.marketscreener.com/VALNEVA-54466/news/VALNEVA-Announces-FDA-Approval-of-Accelerated-IXIARO-Vaccination-Schedule-27381634/