Update
$Valneva (VALN.US)$ Pfizer, Valneva Report Further Positive Phase 2 Booster Results For Lyme Disease Vaccine Candidate
Drug makers Pfizer Inc. (PFE) and Valneva SE (VALN) announced Tuesday positive immunogenicity and safety data from their VLA15-221 Phase 2 study following a second booster vaccination of their Lyme disease vaccine candidate, VLA15, given one year after receiving the first booster dose.
Pfizer aims to submit a Biologics License Application or BLA to the U.S. Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency in 2026, subject to positive Phase 3 data.
In a statement, the companies noted that the immune response and safety profile of VLA15 one month after receiving the second booster dose were similar to those reported after receiving the first booster dose. It showed compatibility with the anticipated benefit of a booster vaccination prior to each Lyme season.
Drug makers Pfizer Inc. (PFE) and Valneva SE (VALN) announced Tuesday positive immunogenicity and safety data from their VLA15-221 Phase 2 study following a second booster vaccination of their Lyme disease vaccine candidate, VLA15, given one year after receiving the first booster dose.
Pfizer aims to submit a Biologics License Application or BLA to the U.S. Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency in 2026, subject to positive Phase 3 data.
In a statement, the companies noted that the immune response and safety profile of VLA15 one month after receiving the second booster dose were similar to those reported after receiving the first booster dose. It showed compatibility with the anticipated benefit of a booster vaccination prior to each Lyme season.
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