Tuesday, Valneva SE VALN and Pfizer Inc. PFE launched immunogenicity and security knowledge from their VLA15-221 Part 2 examine following a second booster vaccination of their Lyme illness vaccine candidate, VLA15, given one 12 months after receiving the primary booster dose.
One month after receiving the second booster dose, the immune response and security profile of VLA15 had been much like these reported after receiving the primary booster dose, displaying compatibility with the anticipated good thing about a booster vaccination earlier than every Lyme season.
Additionally Learn: Pfizer/Valneva’s Vaccine Research For Tick-Borne An infection Completes Major Vaccination Collection, Plans Approval In 2026.
A excessive proportion of individuals seroconverted after the second booster dose, yielding seroconversion charges (SCRs) above 90% for all outer floor protein A (OspA) serotypes in all age teams, consistent with SCRs after the primary booster.
Seroconversion is the method by which the physique develops antibodies within the blood serum in response to an an infection or immunization.
Geometric Imply Titers had been comparably excessive at one month submit first and second booster (i.e. month 19 vs. month 31).
In August 2022, Pfizer and Valneva initiated the presently ongoing Part 3 VALOR examine to analyze the efficacy, security and immunogenicity of VLA15 in individuals 5 years of age and older in extremely endemic areas within the U.S. and Europe.
The first vaccination sequence for all individuals was accomplished in July 2024.
A second Part 3 examine (VLA15-1012), aiming to supply additional proof on the security profile of VLA15 within the pediatric inhabitants, can be ongoing.
Pfizer goals to submit advertising purposes to the FDA and the European Medicines Company in 2026, topic to optimistic Part 3 knowledge.
There are presently no authorized human vaccines for Lyme illness, and the corporate says VLA15 is the vaccine candidate that has superior the furthest alongside the scientific growth timeline, with two Part 3 trials in progress.
The Facilities for Illness Management and Prevention has estimated that roughly 476,000 folks within the U.S. are identified and handled for Lyme illness annually, and 129,000 instances are reported yearly in Europe.
Value Motion: VALN inventory is down 0.27% at $7.30, and PFE inventory is down 2.13% at $28.40 on the final verify on Tuesday.
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