VLA

By Maitane Sardon

Pfizer Inc. and Valneva SE have decided to halt some clinical trials testing its vaccine against Lyme disease following violations of good practices at certain clinical trial sites, Valneva said Friday.

The decision affects a significant percentage of participants in the U.S. who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists Phase 3 clinical study, the French biotech company said.

The study participants, which represent roughly half of the total recruited participants in the trial, are being excluded following violations of good clinical practice at certain clinical trial sites run by a third-party operator, it said.

Valneva said the decision wasn't related to any safety concerns with the vaccine nor was it prompted by a participant-reported adverse event, noting that the trial remains ongoing at other sites not operated by the third party.

Write to Maitane Sardon at maitane.sardon@wsj.com

(END) Dow Jones Newswires

February 17, 2023 02:58 ET (07:58 GMT)

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