An experimental vaccine from Pfizer and Valneva reduced the risk of developing Lyme disease by more than 70%, according to newly released data. Though results appear to have missed a key statistical bar, the companies said they would still be approaching regulators in hopes the vaccine would be approved.
The vaccine could represent a weapon for preventing Lyme, a bacterial infection carried by ticks that is diagnosed and treated in an estimated 476,000 people in the U.S. each year, as well as 132,000 annually in Europe. Early symptoms can include a gradually expanding bull’s-eye rash as well as fatigue, fever, and joint pain; left untreated it can cause joint, heart, and nerve problems.
Fighting Lyme has been a major focus of Robert F. Kennedy Jr., the U.S. health secretary. But the methodological issue at the center of the trial could become a source of controversy both at the Food and Drug Administration, which approves vaccines, and at the Centers for Disease Control and Prevention, which makes vaccine recommendations. The Lyme vaccine is one of the only new vaccines likely to go before both agencies in the near future.
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