Pfizer Inc (PFE)

[DewDiligence]

Phase-3 Lyme-vaccine update:

https://finance.yahoo.com/news/valneva-reports-full-2022-results-060000302.html

In August 2022, the companies initiated a Phase 3 clinical study, "Vaccine Against Lyme for Outdoor Recreationists (VALOR)", to investigate the efficacy, safety and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the United States and Europe.

In February 2023, Pfizer, as the study sponsor, decided to discontinue half of the total enrolled participants in the trial following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator [see #msg-171235185]. The clinical trial remains ongoing at sites not operated by the third party. The companies intend to work with regulatory authorities and, as previously announced, aim for Pfizer to potentially maintain the original submission timelines, pending successful completion of the Phase 3 studies and subject to the agreement of these regulatory agencies to proposed modifications of the clinical trial plan.

Despite what it says above, the BLA submission for VLA15 will almost certainly be delayed by the aforementioned CRO screw-up.