Phase III commencement of Lyme disease vaccine was announced by Valneva and Pfizer earlier this month. The vaccine, VLA15 is the only vaccine of its kind that has progressed to the clinical development stage.
French company Valneva had announced in April of 2020 that a collaborative agreement had been reached with Pfizer which gave the company the rights to codevelop and commercialize the vaccine. Fast forward to June of 2022, Pfizer acquires an 8.1% stake in Valneva.
As the cases of Lyme disease increase in several countries, the announcement of the clinical test has been welcome news. According to the Centers for Disease Control and Prevention, the annual diagnosis rate of Lyme disease is approximately 476 thousand people in America. UK has also seen a steep rise in cases over the years. With only 3.8 cases per million people back in 1997-2000, the number has risen to 27.7 cases per million in 2018, which is a 629% rise in almost 20 years.
Sukanya Narasimhan (Ph.D.), an associate professor at Yale School of Medicine says that “In the last 20 years, this is the biggest buzz in the vaccine market for Lyme disease.”
Another name for Lyme disease is borreliosis because the bacteria that is the source of the disease is called Borrelia. The current course of treatment for Lyme disease is antibiotics.
The multivalent design of VLA15 is one of its main pros, which enables it to be effective against a number of serotypes, according to Narasimhan. It works against six serotypes of Borrelia.
In the late 90s, Lymerix vaccine was introduced for Lyme disease but it did not make it to the market. The difference between that and VLA15 is that Lymerix only targeted one serotype which was mostly found in the US, while VLA15 targets six which are commonly found in the US and UK.
The Phase II results for VLA15 were revealed back in October 2020. Positive results showed over 90% success rate in all serotypes even for people aged between 50 and 65 years. After the administration of a booster, the same study in September 2021 revealed a 100% success rate.
The Phase III study will be conducted on adults as well as children. 6,000 participants will be recruited all aged five or older. The goal is to conduct the tests in a maximum of 50 clinical locations, which include nations that are more prone to the disease.
A major concern revolves around the acceptability of the people. Historically, people have been hesitant and completely dismissed vaccines. Such was the case with vaccines for Lyme disease that previously came into being. The lack of demand drove them out of existence. Companies are concerned that VLA15 could potentially face similar circumstances.
Even though VLA15 is the first vaccine to reach the Phase III clinical stage, many companies are working on their own Lyme disease vaccines. According to GlobalData, a total of seven vaccines are being developed for Lyme disease, of which all but VLA15 are in preclinical stages. One of these is developed by Intravacc.