Pfizer, Valneva Lyme vaccine enters EMA review

• Pfizer and Valneva said the EMA validated the marketing application for PF-07307405, allowing the Lyme disease vaccine candidate to enter regulatory assessment.
• Valneva’s Paris-listed shares were up about 16.9% at €2.86 when checked after the announcement.
• The application is supported by Phase 3 VALOR data showing more than 70% efficacy in participants aged five years and older.

Pfizer (NYSE:PFE) and Valneva (NASDAQ:VALN) said the EMA validated their PF-07307405 Lyme vaccine application after Phase 3 efficacy exceeded 70%.

The filing follows VALOR results showing 73.2% efficacy from 28 days after dose four, although the first prespecified analysis did not meet its statistical criterion.

PF-07307405 was tested in people aged five years and older, was reported as well tolerated, and showed no identified safety concerns in the Phase 3 trial.

Following the announcement, Valneva's share price was up about 16.9% at €2.86 in Paris when checked.

Pfizer and Valneva entered a collaboration agreement in April 2020, with Pfizer responsible for exclusive manufacturing and commercialization if PF-07307405 receives regulatory approval.

Pfizer and Valneva say no human Lyme disease vaccine is currently approved, while PF-07307405 has completed two pivotal Phase 3 studies.