There has been a lot of confusion about the Lyme Vaccine, here is a synopsis of the history of Lyme vaccines to present day.
The first Lyme Vaccine was put on the market in 1998 only to be removed 3 years later.
“Phase III of the VLA15 clinical trials are expected to start in the third quarter of 2022, subject to regulatory approval.”
1990's: The First Approved Vaccine
In the early 1990s, a company called SmithKline Beecham (LYMErix™) and another company called Pasteur Mérieux Connaught (ImuLyme™) were in a race to gain the first licence for a Lyme Vaccine. Both companies neck to neck in their study phase, recognized the known genetic variability in the OspA within the B. burgdorferi strains, and both chose the most common OspA protein as a target.
“In the LYMErix™ phase III safety and efficacy trial, researchers enrolled 10 906 subjects between 15 and 70 years old who lived in endemic areas and randomised them to receive either the three-dose Lyme vaccine regimen or placebo injections. Vaccinated individuals showed a 76% reduction in Lyme disease in the year following vaccination, with no significant side-effects noted. Based on these promising findings, the U.S. Food and Drug Administration (FDA) approved LYMErix™ on 21 December 1998. Although ImuLyme™ underwent a similar phase III study, the manufacturer, for unpublicized reasons, did not apply to the FDA for licensure.” - The Lyme vaccine: a cautionary tale
LYMErix™ Removed From the Market
While the production of LYMErix™ appeared to be a positive step towards controlling the increase in Lyme infections in people, this proved to be short lived. It was taken off the market only a short time after three years. This was apparently due to negative media coverage, fears of vaccine side-effects, and declining sales. It was reported that the manufacturer took it off the market volunteeringly.”
20 Years Later…
It wasn’t until almost 20 years later did a French biotech company called Valneva decide to take on the task of working towards another Lyme vaccine. They have since completed Phase I and Phase II. The results were positive enough that Pfizer, a company that we are all familiar with if you are up on the Covid Vaccine news, announced on April 30, 2020 that they were jumping in on Phase two of the clinical studies to team up with Valneva for the further development in the Lyme vaccine.
The program is currently the only active Lyme disease vaccine program in clinical development to date. Just this past February (2022) it was announced that the VLA15, which like the previous lyme vaccines, also focuses on targeting the outer surface protein A (OspA) of Borrelia, is currently headed towards a planned Phase 3 clinical trial that will evaluate the vaccine in adults and paediatric subjects five years of age and above. If everything goes as planned, phase III of the VLA15 clinical trials are expected to start in the third quarter of 2022, subject to regulatory approval.
How Does it Work?
When an infected tick latches on and inserts its pincers into its victim. Once its mouthpiece is inserted, the tick alternates between injecting saliva and ingesting blood. When the first of your blood enters the tick’s gut, it signals the (Borrelia) bacteria to begin reproducing, and eventually to travel up into the tick’s salivary glands. Once the bacteria are there, they begin to enter your body via the tick’s saliva.
However, if the person’s blood contains antibodies against the bacteria, they can kill Borrelia in the tick’s gut before the bacteria has a chance to travel to the salivary glands, preventing transmission to the human.
The VLA15 will cover six of the most common types of Borrelia prevalent in North America and Europe.
Note, this will not protect you from other multiple tick-borne diseases that ticks can carry.
In a world where Lyme disease is prevalent and infections will only continue to rise, the VLA15 will be meeting a highly unfulfilled, and in our opinion, desperately needed medical need.
The Results Thus Far
“Valneva SE’s Juan Carlos Jaramillo, M.D., Chief Medical Officer, stated in a press release published on October 20, 2020, “We are extremely pleased with these results which showed an excellent immunological profile, further supported by additional positive data through the Serum Bactericidal Assay (SBA).”
The VLA15 vaccine candidate’s tolerability profile including fever rates was comparable to other lipidated recombinant vaccines or lipid-containing formulations.
Furthermore, as in VLA15-201, no related Serious Adverse Events (SAEs) were observed in any treatment group. Reactogenicity decreased following the first vaccination.” - Precision Vaccinations
Takeaways
The original vaccine, LYMErix™, approved in 1998 only lasted on the market for 3 years.
The VLA15 shows promising results and looks like it will be on the market in the next few years if everything goes as planned.
The VLA15 will target six of the most common types of Borrelia prevalent in North America and Europe.
We will still need to be vigilant in using protection against ticks because there are many other debilitating diseases they can carry and transmit.
It is important again to note that ticks can carry a variety of other vector borne diseases and proactive protection on top of the vaccine is a must.
Kommentare