New effort for Lyme disease vaccine draws early fire

A French company is working on a vaccine for Lyme disease, despite opposition from patient advocacy groups. In March, Valneva SE announced initial Phase I clinical trial results after testing its proposed vaccine in 180 healthy adults who experienced no serious adverse effects.

A French company is working on a vaccine for Lyme disease, despite opposition from patient advocacy groups. In March, Valneva SE announced initial Phase I clinical trial results after testing its proposed vaccine in 180 healthy adults who experienced no serious adverse effects. The company plans to launch a Phase II clinical trial later this year to determine dosing. An earlier Lyme vaccine, Lymerix, was voluntarily discontinued in 2002 after class-action lawsuits alleged it caused adverse effects such as arthritis. Although experts say Lymerix was effective—and there was no evidence that it caused arthritis or other serious adverse effects, according to many experts—the vaccine was ultimately discontinued due to low demand. Valneva CFO David Lawrence says there are two main differences with the new proposed vaccine: it protects against six strains of Lyme disease, while the old vaccine protected against only one; and to address unsubstantiated concerns about adverse effects, the company cut a gene sequence in the vaccine that has been linked to arthritis. However, Lyme disease patient advocacy groups are raising alarms, citing safety concerns about the older vaccine. Experts say a vaccine is the best option to greatly limit the spread of Lyme disease, arguing that other prevention methods are inadequate.