Health
Pfizer Begins Trial of Lyme Disease Vaccine with French Partner Valneva
Pfizer and its French partner are beginning large-scale clinical trials of the only vaccine to prevent Lyme disease, the companies announced Monday.
The vaccine, now called VLA15, could be an important tool in stopping tick-borne diseases if it proves safe and effective. nearly 500,000 Americans a yearMany people cure their infections with a course of antibiotics, but some suffer from lingering symptoms for years.
The first signs of a dangerous tick bite include a bullseye rash, fatigue, fever, headache, muscle aches, and neck stiffness. Without proper treatment, lime can cause arthritis, heart disease, and affect the nervous system.
The previous Lyme vaccine, LYMErix, was Withdrawn from the market in 2002 rear Although concerns about its safety have not been proven, Declining public interest, its maker, GlaxoSmithKline, has withdrawn it.
The trial, in collaboration with French company Valneva, will enroll approximately 6,000 volunteers aged 5 and older at 50 sites in several countries where Lyme disease is a problem, including the United States.
VLA15 will be given in 3 primary doses followed by booster doses. Half of the volunteers will receive a saline placebo for the first three doses and half will receive a saline placebo as a booster.
The vaccine targets the outer surface protein of Borrelia burgdorferi, which causes Lyme disease. Blocking this protein apparently inhibits the bacteria’s ability to jump from ticks to humans.
look:Lyme disease on the rise: What to do if you’re bitten by a tick
This vaccine protects against six forms of the protein expressed by bacterial species present in North America and Europe.
In previous trials, both in the laboratory and in people, the vaccine “demonstrated a strong immune response and a satisfactory safety profile,” the companies said.
Assuming this Phase 3 trial goes well, the company could submit an application for approval to the Food and Drug Administration in 2025.
“With increasing rates of Lyme disease worldwide, people are looking for new options to protect themselves from the disease,” said Annalisa Anderson, senior vice president and head of vaccine research and development at Pfizer, in a statement. “We hope that the data from the Phase 3 trial will further support the positive evidence for VLA15 to date.”
Pfizer has agreed to make a $25 million milestone payment to Valneva with the start of the trial on Monday. The two companies have been collaborating on the joint development of a vaccine since April 2020.
Please contact Karen Weintraub at [email protected].
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