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2023-06-16| Trials & Approvals

Valneva’s Breakthrough Chikungunya Single-shot Vaccine: Release Phase 3 Data

by GeneOnline
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Valneva, a specialized company in vaccine development and global market, has released its research clinical data of Chikungunya Vaccine candidate Phase 3, VLA1553. The publication of research data of VLA1553 can be found in the medical journal The Lancet.

Currently, Chikungunya virus (CHIKV) infection has spread to over 110 countries, and it is considered a serious risk to public health. There are no reliable treatments or vaccines available for purchase. Chikungunya is a viral infection spread by Aedes mosquitoes. After four to seven days of being bitten by a host mosquito, 72-92% of people will show symptoms.

Related article: GSK Wins Approval For World’s First RSV Vaccine

VLA1553: The Only Chikungunya Vaccine Under Priority Review 

VLA1553 is a single-dose experimental vaccine designed from deleting a fragment of the chikungunya virus genome. VLA1553 is a potential vaccine that targets Chikungunya virus and the only vaccine candidate phase 3 under priority review process due August 2023 by the U.S. Food and Drug Administration (FDA).

 In 2018, VLA1553 received FDA Fast Track and later in 2021 was granted Breakthrough Therapy designations. In 2022, the final pivotal trial was reported by Valneva with a twelve-month persistence data. Additionally, Valneva conducted a study in Brazil on young people for the clinical trials of the vaccine, for which completion of shots was reported in February 2023.

Positive Pivotal Trial Results of Chikungunya Vaccine

The article published by Valneva in The Lancet medical journal “A Study on a Chikungunya Vaccine: Results from a Phase 3 Trial” gives the results obtained from a pivotal trial, Phase 3, it shows that after participants receive the single dose of VLA1553 a 98.9% developed an immune response within 28 days. These results took effect in both younger and older adults with a 96% of immune response for six months.

The Chief Medical Officer of Valneva, Dr. Juan Carlos Jaramillo, expressed, “This publication in the Lancet underlines the strength of VLA1553’s scientific approach and is consistent with the quality of our pivotal Phase 3 study. We are pleased that more detailed results on our single-shot chikungunya vaccine candidate are now available to the scientific and broader public health communities.”

If Biological License Application (BDA) granted VLA1553 has the potential to be the only chikungunya vaccine available for treating this worldwide healthcare issue. Valneva plans to bring this vaccine to the market and expand its existing commercial vaccines portfolio.

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