Pfizer-Valneva Lyme vax heads to phase 3 trials

Pfizer and French biotech Valneva's Lyme disease vaccine is moving to phase 3 trials after data shows that it successfully elicits immune responses in patients.

In April 2020, Pfizer bought the rights to commercialize VLA15 from Valneva in co-development deal worth up to $308 million. The deal was signed when phase 2 clinical trials testing a two-dose series of the vaccine were already in progress.

Together they initiated another phase 2 trial, testing a three-dose series of the vaccine in patients. Data found the three-dose elicited a stronger immune response in patients, moving the study forward into phase 3.

If approved, VLA15 can make big waves. It is currently the only Lyme disease vaccine candidate in clinical development. VLA15 targets the outer surface protein A of the bacteria that cause Lyme disease. It was granted fast track designation by the U.S. FDA in July 2017.

One vaccine for Lyme disease, called LYMERix was previously available in the U.S. The drug was manufactured by the SmithKline Beecham, now GSK, after receiving approval in 1998 but was discontinued in 2002 because of insufficient demand, according to the company. Some patients who received LYMERix complained of arthritis after vaccination. Although an FDA investigation found the evidence was not strong enough to establish a link between the two, demand fell and the company pulled the drug.