Chikungunya Vaccines 2023
Chikungunya Vaccines May 2023
Like many vaccines under clinical development, Chikungunya vaccine candidates investigate technologies, such as live-attenuated virus vaccines, inactivated viral vaccines, recombinant viral vaccines, chimeric-alphavirus candidates, DNA vaccines, and virus-like particles, which focus on optimizing the balance between immunogenicity and safety, says the World Health Organization (WHO). The U.S. Food and Drug Administration (FDA) has not approved a chikungunya virus preventive vaccine as of May 30, 2023.
U.S. CDC and Chikungunya Vaccines
The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) meeting on February 23, 2023, including these presentations: Introduction, Dr. Beth Bell; Global epidemiology of Chikungunya, Dr. Susan Hills; Chikungunya in U.S. travelers, Ms. Nicole Lindsey; Persistent arthralgia following chikungunya, Ms. Nicole Lindsey; Workgroup considerations, Ms. Nicole Lindsey. Previously on October 19, 2022, the ACIP reviewed the following presentations led by Beth Bell, MD, MPH Chair, ACIP Chikungunya Vaccines Work Group; OVERVIEW OF CHIKUNGUNYA AND CHIKUNGUNYA VACCINES; VLA1553 Chikungunya Vaccine Candidate; CDC WORKGROUP INTERPRETATION OF VACCINE DATA AND WORKGROUP PLANS AND TIMELINES. And on June 23, 2022, the ACIP presentation by Dr. B Bell and Dr. S Hills: Overview of chikungunya and chikungunya vaccines; Plans and timeline for workgroup activities, offered relevant insights.
Chikungunya Vaccine Candidates 2023
VLA1553 is a monovalent, single-dose, live-attenuated vaccine candidate. VLA1553 has been assigned an FDA Prescription Drug User Fee Act review goal date at the end of August 2023 and filed a regulatory application with Health Canada for marketing approval on May 30, 2023.
CHIKV-VLP vaccine candidate is licensed by the National Institute of Allergy and Infectious Diseases. PXVX0317 received Fast Track designation from the U.S. FDA in May 2018 and launched phase 3 studies in 2022. PXVX0317 is a CHIKV virus-like particle vaccine owned by Bavarian Nordic A/S.
mRNA-1944 encodes a fully human IgG antibody isolated initially from the B cells of a patient with a prior history of potent immunity against Chikungunya infection.
CD8+ T cell CHIKV Adaptive Vaccine candidate. Inclusion of the ligandome into the vaccine construct will require the selection of eight to twelve peptides from amongst the CHIKV peptide set (ligandome), all of which meet several specific criteria. In vitro, efficacy studies will then need to be completed.
Chikungunya Vaccine Market
Market Research Future announced on December 6, 2022, the Chikungunya vaccine market is expected to register a CAGR of 10.12% from 2022 to 2030.
Chikungunya outbreak news in April 2023 is posted at this link.
Chikungunya Vaccine News 2023
May 30, 2023 - Valneva SE announced the filing of a regulatory application with Health Canada for marketing approval of VLA1553. This is the second regulatory application for VLA1553 filed by Valneva, and the Company intends to make additional regulatory submissions in 2023.
February 2, 2023 - Merck confirmed to Fierce Biotech that it had discontinued the chikungunya vaccine program as part of a "routine pipeline prioritization."
December 23, 2022 - Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, "Completing our BLA submission is essential as it takes us a step closer to potentially bringing a preventative solution to fight this debilitating disease."
December 7, 2022 - The UK's Newton Fund supports the development of vaccines against Chikungunya, Zika, and Dengue.
November 28, 2022 - Emergex Vaccines Holding Limited announces that it has generated a Chikungunya ligandome, the first significant milestone in developing Emergex's CD8+ T cell CHIKV Adaptive Vaccine candidate.
November 1, 2022 - "We are pleased with these positive Phase 2 study results that support the potential utility and continued development of a chikungunya vaccine candidate (CHIKV-VLP) to help prevent chikungunya disease, including in those who have previously received another alphavirus vaccine," said Chris Cabell, M.D., chief medical officer, and SVP clinical development at Emergent BioSolutions.
October 10, 2022 - Valneva SE presented: "One step closer to a chikungunya vaccine: update on Valneva's live-attenuated vaccine candidate."
August 18, 2022 - Valneva SE announced that it had initiated a rolling submission of the Biologics License Application to the U.S. FDA, seeking approval of the VLA1553 chikungunya vaccine candidate.
June 13, 2022 - The Lancet Infectious Diseases published - Safety aImmunogenicityity of PXVX0317: a randomized, double-blind, parallel-group, phase 2 trial. Interpretation - PXVX0317 was well tolerated and induced a robust and durable serum-neutralizing antibody immune response against CHIKV for up to 2 years.
March 31, 2022 - Dr. Mike Ryan, head of the WHO's Emergency Programme, explained the "broad but related threats" posed by Dengue, Yellow fever, Chikungunya, and Zika in different parts of the world.
March 8, 2022 - Valneva SE announced the successful completion of the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. The positive final analysis included six-month follow-up data and confirmed the topline results reported in August 2021. Under the accelerated approval pathway, the company expects to commence the pre-submission process with the U.S. FDA in the second quarter of 202y.
February 22, 2022 - U.K.-based Emergex Vaccines Holding Limited announced it was awarded a £490,525 grant by the U.K. government's Department of Health and Social Care to advance a synthetic T-cell vaccine candidate for the Chikungunya virus.
January 31, 2022 - Prof. Dimas Tadeu Covas, President of Instituto Butantan, which sponsors the Valneva phase 3 trial in Brazil, commented in a press release, "VLA1553 is currently the most clinically advanced chikungunya vaccine candidate worldwide, having completed Phase 3 in adults."
December 21, 2021 - Valneva SE reported that the VLA1553-302 clinical trial met its primary endpoint. It demonstrated that three consecutively manufactured vaccine lots elicited equivalent immune responses measured by neutralizing antibody titer GMT ratios on Day 29 after vaccination with VLA-1553. Lot-to-lot trials show manufacturing consistency, one of the standard requirements for vaccine licensure.
October. 15, 2021 - Emergent BioSolutions Inc. announced the first participant dosed in its pivotal phase 3 study evaluating the safety and immunogenicity of its investigational chikungunya virus virus-like particle vaccine candidate, CHIKV VLP, in a single dose.
August 5, 2021 - Valneva SE announced positive topline results from the Phase 3 pivotal trial of its chikungunya vaccine candidate, VLA1553. The trial, involving 4,115 adults aged 18 years and above across 44 sites in the U.S., met its primary endpoint by inducing protective CHIKV-neutralizing antibody titers in 98.5% of participants 28 days after receiving a single shot (264 of 268 subjects from the per-protocol subgroup tested for immunogenicity, 95%CI: 96.2-99.6). In addition, the seroprotection rate result of 98.5% exceeded the 70% threshold (for non-acceptance) agreed with the U.S. FDA.
September 12, 2019 - Moderna, Inc. announced positive data in the first analysis of safety and activity in its Phase 1 study evaluating escalating doses of mRNA-1944 administered via intravenous infusion in healthy adults. mRNA-1944 encodes for an antibody (CHKV-24) with activity against the chikungunya virus.
Note: This information has been fact-checked by healthcare providers.