Pfizer and its partner Valneva said on March 23 that their experimental Lyme disease vaccine did not meet the target in a clinical trial, but that the results were strong enough that the firms will seek regulatory approval for the shot.
The vaccine, known as LB6V, was about 75 percent efficacious in reducing confirmed Lyme in recipients compared with placebo recipients, the companies said. The efficacy was measured one day after the fourth vaccine dose, and was similar to the 73 percent efficacy observed 28 days after the fourth shot.
The drugmakers said that because there were fewer Lyme cases than expected during the trial, dubbed VALOR, the predetermined statistical target was not met. However, because the efficacy was “clinically meaningful,” the companies expressed confidence in the shot and said they would be filing for approval.
“The efficacy shown in the VALOR study of more than 70 percent is highly encouraging and creates confidence in the vaccine’s potential to protect against this disease that can be debilitating,” Annaliesa Anderson, Pfizer’s chief vaccines officer, said in a statement.
Valneva CEO Thomas Lingelbach said: “[The results] bring us a step closer to our goal of delivering a much-needed vaccine.
“We are grateful to our partner Pfizer for their strong commitment which we both share in developing this vaccine as quickly as possible.”
Hellbound and Down 