Valneva and Pfizer Announce Initiation of Phase 2 Study for Lyme Disease Vaccine Candidate - Seite 3
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Pfizer Forward-Looking Statements
The information contained in this release is as of March 8, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or
future events or developments.
This release contains forward-looking information about a Lyme disease vaccine candidate, VLA15, and a collaboration between Pfizer and Valneva for VLA15, including their potential benefits and a
potential phase 3 start, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates
for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing
clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design
of and results from our clinical studies; whether and when drug applications may be filed in any jurisdictions for VLA15; whether and when any such applications may be approved by regulatory
authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if
approved, whether VLA15 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the
availability or commercial potential of VLA15; the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.