Pfizer, Valneva to stop Lyme disease vaccine trial in some patients
"The discontinuation of these participants was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event," the companies said.
Paris: U.S. drugmaker Pfizer Inc and French vaccine company Valneva will stop testing an experimental Lyme disease vaccine in roughly half of the patients recruited in a U.S. trial, the companies said on Friday.
The late-stage trial was expected to include around 6,000 participants aged 5 and older in areas where Lyme disease, usually caused by poppyseed-sized ticks, is highly endemic. Studies were stopped at some sites due to violations of clinical trial guidelines by a third-party organization conducting the trial, the companies said, without disclosing the locations.
"The discontinuation of these participants was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event," the companies said.
The financial impact on Valneva is currently difficult to predict, analysts at brokerage Portzamparc said, as it is unclear whether regulatory authorities will be able to accept data from only half of the participants.
The French drugmaker has been pinning its hopes on the vaccine candidate, known as VLA15, to counter the impact of disappointing sales for its COVID shot. If successful, Valneva's Lyme disease vaccine could generate annual global sales of $1 billion, given the burgeoning tick populations, rising infection rates and the incidence of long-term complications.
Paris-listed shares of Valneva fell nearly 10% to 5.72 euros following the news and U.S.-listed shares of Pfizer were down marginally in premarket trading.
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