DENMARK — Bavarian Nordic has achieved a significant milestone in its phase 3 clinical trial for a chikungunya virus vaccine, positioning the Danish drugmaker as a strong contender in the race to market, alongside Valneva’s almost-approved candidate.
While awaiting FDA approval for its vaccine, Valneva may face swift competition from Bavarian Nordic, which acquired the rights to a chikungunya vaccine candidate earlier this year.
The initial phase 3 trial results indicate that Bavarian Nordic’s vaccine can rival Valneva’s, although further analysis is needed to determine if it meets the high standard set by its competitor.
The trial involved 413 participants aged 65 years and older who were randomized to receive the vaccine candidate or a placebo.
It is important to note that differences in trial design and measurement of antibody levels between Bavarian Nordic and Valneva may affect the interpretation of comparative data.
Valneva’s phase 3 trial included mostly participants aged 18 to 64 years, while Bavarian Nordic’s ongoing second phase 3 trial targets individuals aged 12 to 64 years.
Data from the second trial are expected in the third quarter, and the promising results in seniors suggest that Bavarian Nordic’s vaccine will offer high rates of seroprotection in the younger population.
In the phase 3 trial, the virus-like particle vaccine triggered neutralizing antibodies above the seroprotection threshold in 87% of participants within 22 days of a single intramuscular injection.
By day 15, 82% of participants had surpassed the threshold, confirming Bavarian Nordic’s belief in the vaccine’s rapid protective effect.
Dr. Chaplin, a representative of Bavarian Nordic, described the results as “highly encouraging” and consistent with previous findings in younger adults from an earlier phase 2 study.
Importantly, the chikungunya vaccine demonstrated excellent tolerability in the older adult population, with adverse event rates similar to those observed in the placebo group. The trial will continue with a six-month follow-up to assess safety and immunogenicity.
The results from a second phase 3 study evaluating the safety and immunogenicity of the vaccine in healthy adolescents and adults aged 12 to 64 years are expected to be announced in the third quarter, providing further insights into the vaccine’s efficacy and potential broader applicability.
Chikungunya virus is spread to people by infected mosquitoes. Symptoms include fever, incapacitating joint pain, headache, muscle pain, joint swelling, or rash.
Like many tropical diseases, the reach of the virus is spreading into a wider range of countries.
Merck concedes the Chikungunya vaccine race
In a significant turn of events, Merck & Co. has conceded defeat in the race to bring the first chikungunya vaccine to market, as Valneva and Bavarian Nordic now emerge as the frontrunners.
Merck’s contender in the race was V184, a vaccine obtained through the company’s acquisition of Themis for US$366 million in 2020.
Although V184 successfully completed a phase 2 trial, the study experienced a suspension period from December 2020 to June 2021 due to a “clinical stock recovery action.”
Consequently, the vaccine fell short of its original enrollment target, impacting its progress.
In response to inquiries from Fierce Biotech, Merck confirmed that it has made the decision to discontinue its chikungunya program.
The discontinuation is part of the company’s routine pipeline prioritization, reflecting the strategic choices made to allocate resources efficiently and effectively.
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