Pfizer, Valneva say 'positive' result for Lyme disease vaccine candidate booster

[September 08, 2023]  (Reuters) -Pfizer and French pharmaceutical peer Valneva announced on Thursday that a phase 2 study for its VLA15 Lyme disease vaccine candidate showed a "strong immune response" in both children and adolescents a month after a booster shoot.

"The Phase 2 booster results emphasize the vaccine candidate’s potential to provide immunity against Lyme disease in paediatric and adolescent populations," the two companies said in a statement.

"VLA15 well-tolerated in all age groups following booster dose."

Pfizer says it intends to submit regulatory applications for VLA15, which Valneva presents as being "the most advanced Lyme disease vaccine candidate currently in clinical development", to both the European Medicines Agency and U.S. Food and Drug Administration by 2026 if the phase 3 clinical trial, launched last year, gives positive results.

The New-York-based drug giant previously said it aimed to file for regulatory authorisations by 2025.

In February, Pfizer and Valneva announced they had to end VLA15 trials for a significant amount of U.S. participants due to "violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator".

(Reporting by Victor Goury-Laffont; Editing by Janane Venkatraman, Robert Birsel)

[© 2023 Thomson Reuters. All rights reserved.]This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.