Pfizer Lyme Vaccine Moves to EMA Review

Pfizer and Valneva announced on 14 August that the European Medicines Agency validated the Marketing Authorization Application for PF-07307405. The move starts the formal regulatory review in Europe for the experimental Lyme disease vaccine candidate.

The candidate stems from a 2020 partnership agreement between both companies. Under the deal, Pfizer holds exclusive rights to produce and commercialize the vaccine if authorities approve it, while Valneva participates as a development partner.

The filing relies on the Phase 3 VALOR trial with 9,437 participants aged five and older across the United States, Canada, and Europe. Patients received four doses, with the first three given at months zero, two, and five to nine, followed by a fourth dose about a year later. March 2026 topline data showed overall efficacy above 70% and no safety issues. However, the primary endpoint analysis reached 73.2% efficacy but missed the statistical mark because the lower bound of the 95% confidence interval was 15.8%, below the required 20%. A second prespecified analysis showed 74.8% efficacy and met the threshold.

Pfizer shares traded essentially flat after the update. In the second quarter of 2026, 83 hedge funds held positions in the company, unchanged from the first quarter. If approved, the product would address an at-risk European market of more than 200 million people.