Pfizer Launches Phase 3 Trial For Lyme Disease Vaccine

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Pfizer announced this week that it had launched the final phase of testing for an experimental vaccine to prevent Lyme disease in people 5 years old and above.

Pfizer and its French partner Valneva, will enroll about 6,000 volunteers, ages 5 and up for the late-stage clinical trial that will test the vaccine, VLA15, against the tick-borne illness, according to a press release.

The Defender reports: The company plans to create a seasonal vaccine that people age 5 and older can get during the months when ticks are most active.

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If approved, the vaccine could be the first human vaccine available for Lyme disease in the U.S. in more than two decades after LYMERix, manufactured by GlaxoSmithKline, was withdrawn from the market in 2002, due to lawsuits, safety concerns and dwindling sales.

According to a press release, Pfizer and French partner Valneva are enlisting 6,000 participants ages 5 and older for a late-stage clinical trial that will test the vaccine, VLA15, against the tick-borne illness.

According to ClinicalTrials.gov, “18,000 healthy participants 5 years and older” were recruited for the study. In its press release, Pfizer did not explain the discrepancy in the number of trial participants.

VLA15 is a “multivalent protein subunit vaccine” targeting “the outer surface protein A (OspA) of Borrelia,” the bacteria that causes Lyme disease. The vaccine is supposed to protect against six forms of the protein expressed by the bacterial species present in North America and Europe.

During the Phase 3 clinical trial, participants will receive three doses of VLA15 or a placebo, followed by one booster dose or another placebo, The Washington Post reported.

The study will be held in as many as 50 sites where Lyme disease is “highly endemic,” the drugmakers said, including Finland, Germany, the Netherlands, Poland, Sweden and the U.S.

Pending successful completion of the trials, Pfizer may request approval for its vaccine from regulators in the U.S. and Europe in 2025.