Pfizer, Valneva Lyme vaccine starts review in Europe
After reporting mixed clinical results in a phase 3 trial, Pfizer and Valneva have filed their Lyme disease vaccine candidate PF-07307405 in the EU, and the EMA has started its review.
The six-valent shot – also known as VLA15 and LBV6 – is being reviewed on the back of the 9,500-patient VALOR trial, which demonstrated 73% efficacy in preventing Lyme disease in individuals aged five years and above, who were living in areas with endemic Lyme disease and with lifestyles that put them at increased risk of the tick-borne infection.
The study missed the predetermined statistical criterion for the study, which Pfizer and Valneva said was because there were fewer than anticipated infections during the study.
With that in mind – coupled with the fact that there are as yet no approved Lyme disease vaccines available since GSK's Lymerix was withdrawn more than 20 years ago after sales and demand plummeted due to a safety scare – they have opted to press ahead with filings based on the VALOR dataset.
Lyme disease is the most common vector-borne illness in the Northern Hemisphere and causes a characteristic rash that can be accompanied by flu-like symptoms and, in some cases, debilitating tiredness and aches that last for years.
It is already well-established in Europe, with hundreds of thousands of new cases estimated annually, and has been spreading into new regions of the continent due to changing climate and environmental conditions. Now, more than 200 million people live in Lyme disease risk areas in Europe.
The EU marketing application is believed to be the first for PF-07307405, a three-dose vaccine based on the outer surface protein A (OspA) of the Borrelia burgdorfii bacteria responsible for the disease.
"I'm proud of the progress we have made with our Lyme disease vaccine candidate and excited about the opportunity to potentially bring the first vaccine of its kind to Europe," said Annaliesa Anderson, Pfizer's chief vaccines officer.
"I look forward to collaborating with the EMA as this vaccine candidate advances through the review cycle," she added. "We believe vaccination has the potential to provide an important new layer of protection against this debilitating disease and help people continue to enjoy the outdoors with greater confidence."
Other companies working on preventative medicines for Lyme disease include Moderna, which has two mRNA-based vaccine candidates in mid-stage clinical testing, and Tonix Pharma, which is running trials of anti-OspA antibody, TNX-4800, intended for use after exposure to ticks.
Photo by Erik Karits on Unsplash
