Pfizer and Valneva (Nantes company) announced, in August 2022, the initiation of a phase 3 clinical study, the last before marketing authorization applications, to assess the efficacy, safety and immunogenicity of their experimental Lyme disease vaccine candidate, currently called VLA15.
The study, titled VALOR, “
randomized, placebo-controlled, expected to enroll approximately 6,000 participants aged 5 years and older“Said Valneva’s press release. She “
is conducted at up to 50 sites located in areas where Lyme disease is highly endemic, including Finland, Germany, the Netherlands, Poland, Sweden and the United States“.
If successfully finalized, Pfizer could submit marketing authorization applications to the US FDA and European Medicines Agency in 2025.
VLA15 is the only Lyme disease vaccine in clinical development, reported Fierce Biotech in February 2022.
For more information, see the links below.
Psychomedia with sources: Valneva, Fierce Biotech.
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