Valneva Vaccine Shows Sustained Immune Response In Adolescents One Year After Single Shot

On Tuesday, Valneva SE VALN reported Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine, Ixchiq.

The vaccine showed a sustained 98.3% sero-response rate one year after the single vaccination.

These results support and strengthen the pivotal data previously reported for adolescents (12 to 17 years old), which supported filing for potential label extension to this age group in the U.S., Europe, and Canada.

Also Read: Valneva’s Chikungunya Shot Shows Strong, Long-Lasting Antibody Persistence At Three Years, Comparable In Older And Younger Adults

Data from this trial are also expected to support the licensure of Ixchiq in Brazil. It would be the first potential approval for use in endemic populations.

The one-year VLA1553-321 data showed that a single-dose vaccination induced a high, sustained immune response in an immunogenicity subset of participants who were CHIKV negative at baseline, with a seroresponse rate of 98.3% (232 out of 236 participants) one year after vaccination (Day 360) compared to 99.1% (232 out of 234 participants) after six month3 (Day 180) and 98.8% (248 out of 251 participants) 28 days after vaccination.

The results complement the long-term persistence data previously reported for adults. They also confirm a strong and long-lasting antibody response to the vaccine.

Additionally, the one-year data confirmed that a single dose of the vaccine was generally well tolerated in adolescents.

Throughout the trial, an Independent Data Safety Monitoring Board (IDSMB) consistently assessed safety data and found no safety issues.

The vaccine is currently approved in the U.S., Europe, and Canada to prevent disease caused by the chikungunya virus in individuals 18 and older.

In addition to Brazil, Valneva expects to receive marketing approval in the United Kingdom in the first quarter of the year.

Price Action: Valneva stock is 9.84% at $4.80 during the premarket session at last check Tuesday.

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