Lyme disease vaccine set back by bodged Phase III trial

5 May 2023

The poor execution of a Phase III trial in Lyme disease has set back plans to submit vaccine candidate VLA15 for regulatory approval in the USA.

Developers Valneva (Nasdaq: VALN) and Pfizer (NYSE: PFE) disclosed in February that they would have to withdraw some participants from the VALOR study, after violations of clinical trial good practice were discovered.

The trial is being run by contract research organization (CRO) Care Access. In its quarterly results statement, Valneva has now revealed that the setback will delay regulatory submissions until 2026.

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