FDA extends approval deadline for Valneva’s chikungunya vaccine by 3 months
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Key takeaways:
- The FDA delayed the action date for Valneva’s chikungunya vaccine so that a phase 4 post-market trial program can be designed.
- VLA1553 would be the first vaccine against the mosquito-borne virus.
The FDA extended the review period for Valneva’s chikungunya vaccine candidate by 3 months while the design of a phase 4 study is finalized.
According to Valneva, the FDA extended the Prescription Drug User Fee Act (PDUFA) action date from late August to late November to “allow sufficient time to align and agree on the phase 4 program necessary under the accelerated approval process.”
The FDA did not request additional data for the approval process, the company said.
“We are continuing to work closely and collaboratively with the FDA, and we believe it may be possible to obtain an approval before the new PDUFA date,” Juan Carlos Jaramillo, MD, chief medical officer at Valneva, said in a press release.
VLA1553 is a single-shot vaccine that induced protective neutralizing antibody titers in more than 96% of patients 6 months after vaccination in a phase 3 trial among more than 4,000 participants at 22 sites in the United States. If approved, it would be the first vaccine against chikungunya.
Similar to dengue and Zika, chikungunya virus is spread by the bite of infected Aedes mosquitoes.
The virus was not detected often in U.S. travelers until 2006, according to the CDC, and it did not cause a local outbreak in the Americas until 2013.
Phase 4 studies are carried out after a drug has been approved by the FDA as part of post-market safety monitoring, according to the agency.
Valneva said in 2022, when phase 3 trial results for VLA1553 were released, that it was planning to continue an antibody persistence trial for at least 5 years to monitor a subset of participants for anticipated longer term protection from chikungunya.
“We appreciate and take pride in the fact that our [biologics license application] for VLA1553, if approved, will represent the first vaccine candidate to be approved under the accelerated approval pathway in an outbreak disease, and hence the necessary phase 4 activities will set a future standard,” Jaramillo said.
References:
- CDC. Chikungunya virus: Chikungunya in the U.S. https://www.cdc.gov/chikungunya/geo/chikungunya-in-the-us.html. Accessed August 16, 2023.
- FDA. The drug development process: Step 3: clinical research. https://www.fda.gov/patients/drug-development-process/step-3-clinical-research. Accessed August 16, 2023.
- Schneider M, et al. Lancet. 2023;doi:10.1016/S0140-6736(23)00641-4
- Valneva announces PDUFA date extension for chikungunya virus candidate. https://valneva.com/press-release/valneva-announces-pdufa-date-extension-for-chikungunya-virus-vaccine-candidate/. Accessed August 16, 2023.
Perspective
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Chikungunya is an acute viral infection, transmitted by Aedes mosquitoes, that is characterized by the acute onset of a high fever and joint pains. Myalgias, rash, fatigue, nausea and joint swelling may also be present — life-threatening complications are rare, and mortality is low.
The joint pains can be debilitating during the acute illness and often lead infected individuals to seek health care for symptomatic relief. There may be a subsequent post-acute phase lasting several months and, in a subset of infected patients, a chronic phase with persistent inflammatory arthritis.
Prevention of chikungunya through vaccination is an important new option to reduce the burden of disease, including the potential health care costs and long-term adverse outcomes for infected individuals.
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