Accelerated Dosing Regimen Approved for Japanese Encephalitis Vaccine

Valneva USA, the U.S. subsidiary of global vaccine biotech company Valneva SE, has received U.S. Food and Drug Administration (FDA) approval of an accelerated dosing regimen for IXIARO (Japanese encephalitis vaccine, inactivated, adsorbed). IXIARO is the only vaccine approved in the U.S. indicated for protection against disease caused by Japanese encephalitis (JE) virus, a rare but serious disease and the most common form of vaccine-preventable encephalitis and viral-induced neurologic disability in Asia. For effective protection from JE virus, adults aged 18 years to 65 years may now receive two separate doses of IXIARO seven days apart. Previously, the time between doses for this age group was 28 days. The standard 28-day schedule still applies to children 2 months to 17 years and adults 66 years and older; adults aged 18 years to 65 years may also follow this schedule. The accelerated and the standard dosing schedules must be completed at least seven days before travel to endemic areas.

“The FDA approval of this accelerated seven-day dosing schedule is a positive step toward protecting more people from JE,” said Charles Daily, Valneva’s general manager in the U.S. “For travelers who do seek protection with a vaccine prior to travel, oftentimes they are not aware of the dosing schedule and, therefore, have not visited their doctor soon enough to allow for two doses. Eliminating this time barrier will make it easier for patients to plan for their travel health needs and to better protect themselves.”

A recent survey found 72 percent of U.S. adults who traveled to Asia for 10 or more days reported visiting at least one area, or participating in an activity, that put them at increased risk for exposure to JE virus and, based on guidelines, should consider a vaccine along with other protective measures. However, the same survey found more than one-third began preparing for travel less than a month before departure. “I encourage anyone planning international travel to visit a travel health practitioner well in advance of their anticipated departure date to learn about preventative measures for travel-related diseases,” said Scott Morcott, MD, family physician and medical director of Passport Health Chicago. “For those whose travel plans change unexpectedly, this shorter vaccine dosing regimen may help to protect them in less time.”