Article highlights
- Ixchiq Approval: FDA approves Ixchiq as the first Chikungunya vaccine for those 18 and older.
- Accelerated Approval: Approval based on anti-Chikungunya antibody titers, with continued verification required.
- Global Health Threat: Chikungunya virus is an emerging global health threat, particularly in tropical regions.
- Pregnancy Considerations: Warning on vaccine transmission and potential effects in pregnant individuals.
- Clinical Trials Results: Ixchiq's safety evaluated in trials, showing common side effects and effectiveness based on immune response data.
VLA1553 (Ixchiq; Valneva) has been approved by the FDA as the first chikungunya vaccine for individuals aged 18 years and older who are at an increased risk of exposure to the virus, according to a press release from the federal agency.1
The indication was approved via accelerated approval based on anit-chikugunya neutralizing antibody titers, and continued approval is contingent upon verification of clinical benefit in confirmatory studies, according to Valneva.2
Primarily transmitted to people through the bite of an infected mosquito, the chikungunya virus is an “emerging global health threat,” with at least 5 million cases in the last 15 years, according to the FDA.1
Tropical and subtropical regions in Africa, Southeast Asia, and parts of the Americas where virus-carrying mosquitos are endemic are the areas with the highest risk of infection. The global prevalence of the disease is on the rise because of its spread to new geographical areas.1
“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, MD, PhD, director, Center for Biologics Evaluation and Research, FDA, in the press release.1
“Today’s approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options.”1
Prescribing information for the vaccine includes a warning that states it isn’t known if the vaccine virus can be transmitted from pregnant individuals to newborns. It is also not known if the vaccine virus can cause any adverse effects in the newborn.1
When considering administration to pregnant individuals, the warning conveys health care providers should “take into consideration the individual’s risk of exposure to chikungunya virus, gestational age, and risk to the fetus or neonate from disease caused by chikungunya virus in the pregnant individual.”1
Fever and joint pain are the most common symptoms associated with chikungunya, but other symptoms could include headache, rash, and muscle pain. Some individuals infected with the virus have reported joint pain that persists for “months or even years,” the federal agency stated.1
Over-the-counter pain and fever medications, fluids, and rest are current treatments.1
VLA1553, administered as a single dose via injection into the muscle, contains a live, weakened version of the chikungunya virus. This could cause symptoms similar to those who have been infected with the virus.1
A pair of clinical trials in North America evaluated the safety of VLA1553. The studies featured approximately 3500 participants aged 18 years or older, who received a dose of the vaccine, including about 1000 participants who received placebo.1
The effectiveness of VLA1553 is based on immune response data from a US-conducted clinical study. The immune response of 266 individuals who received the vaccine was compared to 96 participants who received placebo.1
Headache, muscle pain, joint pain, fever, fatigue, nausea, and tenderness at injection site were the most reported side effects. Severe chikungunya-like adverse reactions which prevented daily activity or required medical intervention occurred in 1.6% of VLA1553 recipients. None of these adverse reactions occurred in participants who received placebo.1
In August 2023, vaccine company Bavarian Nordic released positive, topline phase 3 trial data for its chikungunya virus vaccine candidate PXVX0317 (CHIKV VLP), for adolescents and adults aged 12 to 64 years.3
The vaccine candidate received Fast Track and Breakthrough Therapy designation from the FDA and data announced in August formed a basis for the submission of a Biologics License Application (BLA) in 2024. For more on this vaccine candidate, click here.3
References:
- FDA approves first vaccine to prevent disease caused by chikungunya virus. FDA. Press release. November 10, 2023. Accessed November 10, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-prevent-disease-caused-chikungunya-virus?utm_medium=email&utm_source=govdelivery
- Valneva announces US FDA approval of world’s first chikungunya vaccine Ixchiq. Valneva. Press release. November 10, 2023. Accessed November 10, 2023. https://valneva.com/press-release/valneva-announces-u-s-fda-approval-of-worlds-first-chikungunya-vaccine-ixchiq/
- Fitch, J. Chikungunya vaccine effective in adolescents after phase 3 trial. Contemporary Pediatrics. August 14, 2023. Accessed November 10, 2023. https://www.contemporarypediatrics.com/view/chikungunya-vaccine-effective-in-adolescents-after-phase-3-trial
