Pfizer and Paris-based partner Valneva will delay the regulatory submission for their Lyme disease vaccine until 2026, following previously disclosed clinical trial hiccups by a third-party trial site operator.
Back in February, Pfizer decided to discontinue testing the VLA15 vaccine in roughly half of U.S. participants, after learning of potential violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator. According to Pfizer, the discontinuation was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event.
At the time, the partners said they would work with regulatory authorities, aiming to submit a Biologics License Application (BLA) to the U.S. FDA and Marketing Authorization Application (MAA) to the EMA in 2025.
But timeline has seemingly shifted. As disclosed by Valneva in its first quarter financial results, additional enrollment for primary immunization in the ongoing VALOR phase 3 trial will begin in the second quarter of 2023, with overall trial continuation to include the 2025 tick season.
"As a result, Pfizer is aiming to submit a BLA to the U.S. FDA and MAA to the EMA in 2026, subject to positive data. Current projected incremental study execution costs incurred due to the agreed amount of additional enrollment will be borne by Pfizer," stated Valneva in the report.
VLA15 — an investigational multivalent protein subunit vaccine — uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. In April 2020, Pfizer bought the rights to commercialize VLA15 from Valneva in co-development deal worth up to $308 million. The deal was signed when phase 2 clinical trials testing a two-dose series of the vaccine were already in progress. According to Pfizer, VLA15 is the only Lyme disease vaccine candidate currently in clinical development.
