Biologics

Pfizer, Valneva to File BLA for Lyme Disease Vaccine

Pfizer and Valneva say they will submit a BLA for their investigational Lyme disease vaccine candidate based on data demonstrating more than 70% efficacy in a late-stage clinical trial, marking a significant step toward what could become the first approved human vaccine for the disease.

The Phase 3 VALOR trial showed the vaccine candidate, known as PF-07307405 (also called LB6V), achieved efficacy rates of 73.2% and 74.8% in preventing confirmed cases of Lyme disease in individuals aged five and older, depending on the analysis. The companies said the vaccine was also well tolerated, with no safety concerns identified at the time of analysis.

Despite the strong efficacy signal, the trial’s primary endpoint was not formally met because fewer Lyme disease cases than expected occurred during the study period, preventing the statistical threshold from being reached in one pre-specified analysis, according to the companies. However, they note the totality of data supports the vaccine’s potential and confirmed plans to move forward with regulatory submissions.

“Lyme disease can cause potentially serious consequences… and there is currently no vaccine available,” said Annaliesa Anderson, Pfizer’s head of vaccines, in a statement. “The efficacy shown in the VALOR study of more than 70% is highly encouraging.”

The vaccine candidate targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria responsible for Lyme disease, according to the companies. By generating antibodies that act within the tick during feeding, the vaccine is designed to block transmission of the bacteria to humans. It covers six major OspA serotypes prevalent in North America and Europe.

The companies say additional details from the VALOR study will be presented at a future scientific meeting.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome