Pfizer and Valneva Report Topline P-III (VALOR) Trial Data on PF-07307405 for Lyme Disease Prevention

Shots:

• Pfizer & Valneva have reported the P-III (VALOR) trial data in pts (≥5yrs.) at high risk of Lyme disease randomized to either PF-07307405 vs saline PBO, with one dose administered at mos. 0, 2, 5-9 followed by a fourth dose 1yr. late
• In pre-specified analyses, efficacy reached 73.2% at 28 days post-dose 4 & 74.8% at 1 day post-dose 4 in reducing the rate of confirmed Lyme disease cases vs PBO
• However, fewer cases accrued and the 1EP was not met as the 95% CI lower bound did not exceed 20 in the first analysis, while the second analysis met this threshold, supporting Pfizer’s planned regulatory submissions based on the vaccine’s efficacy

Ref: Pfizer  |  Image: Pfizer & Valneva | Press Release

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