Lyme Disease (Lyme Borreliosis) is a bacterial infection that is spread to humans by infected ticks. The infection was first known as “Lyme arthritis” after a cluster of cases were appeared in Old Lyme, Connecticut, USA in the late 1970s. This is now the most common tick-borne disease in the USA and Europe.
Research shows that Lyme Disease is affecting some 300,000 and costing the USA in the region of $1.3 billion a year. link. In Europe the disease in growing geographically and is showing incidence of about 250,000 per annum. link
For further details see our previous article on Lyme Disease link.
In 1998 SmithKline Beecham launched a vaccine called LYMErix™. Approved by the FDA, this vaccine was given in a three-dose series. The vaccine stimulated antibodies that attacked the Lyme bacteria in the tick’s gut as it fed on the human host, before the bacteria were able to enter the body. This reduced new infections in vaccinated adults by nearly 80% 78% against Lyme infection after all three doses of the vaccine had been given. LYMErix™ was voluntarily withdrawn from the market by it’s manufacturers in 2002 amid media coverage, fears of vaccine side-effects, and declining sales. link
ImuLyme™ manufactured by Pasteur Mérieux Connaught, Swiftwater, PA, USA, now Sanofi was also announced in 1998. This OspA Lyme vaccine was tested in a large efficacy study and the results published in the July 1998 issue of The New England Journal of Medicine They never applied for a licence to produce the product. link
Baxter International Inc. also tried developing a Lyme vaccine. Baxter announced in April 2013 that – Phase I/II data evaluating the safety and immunogenicity of its investigational Lyme disease candidate company completed a safety study but despite promising results, never launched a follow-up. Baxter’s Lyme disease vaccine was developed with a novel, multivalent chimeric antigen that targets specific immune functions and is designed to protect against the major species of Borrelia, the bacteria known to cause Lyme disease in Europe and the United States. link. Takeda, the largest drug company in Asia, owns that vaccine and is evaluating whether to take it forward. link.
On 1st May 2020, npj Vaccines, a fully open-sourced journal, published a paper written by Heather D. Kamp link titled: “The design of a broadly reactive Lyme disease vaccine”. A six component vaccine that elicits antibody (Ab) responses against all Borrelia strains that commonly cause Lyme disease in humans. The outer surface protein A (OspA) of Borrelia was fused to a bacterial ferritin to generate self-assembling nanoparticles. OspA-ferritin nanoparticles elicited durable high titer Ab responses to the seven major serotypes in mice and non-human primates at titers higher than a previously licensed vaccine. This response was durable in rhesus macaques for more than 6 months. Vaccination with adjuvanted OspA-ferritin nanoparticles stimulated protective immunity from both B. burgdorferi and B. afzelii infection in a tick-fed murine challenge model. This multivalent Lyme vaccine offers the potential to limit the spread of Lyme disease. link
VLA15, is being developed by the French Valneva biotech company, which is a pure play vaccine developer, headquartered in France. The company has also several vaccine programs for infections such as chikungunya and Zika. Valneva is one of the leading European vaccine developers for neglected diseases with a market cap of €289M. link. According to it’s president and chief executive officer, Thomas Lingelbach , VLA15 targets the six most common types of Borrelia. Therefore, the vaccine would work in North America as well as in Europe, where Lyme disease is a growing rapidly. In July 2017 The Food and Drug Administration gave VLA15 fast-track designation and VLA15 completed initial safety studies in a Phase 2 clinical trial and, according to a company press release, VLA15 “had no associated safety concerns.” The company is now working to determine the dose. Based on current estimates, Lingelbach said Valneva plans to test the vaccine in a clinical trial of at least 15,000 people, and it should be available in four or five years. link
In May 2020 it was announced that Valneva will collaborate with US pharmaceutical giant, Pfizer to develop and commercialise Valneva’s phase II-stage Lyme disease vaccine candidate. According to their joint press release in April 2020, VLA15 is the only active Lyme disease vaccine program in clinical development today. link. Pfizer will lead the late-stage development of the vaccine, with Valneva covering 30% of the development costs. Pfizer will then have full control over commercialising the vaccine, and Valneva can expect tiered royalties starting from 19%. link
It is great news to the many Lyme sufferers that there maybe a new vaccine on the market shortly, particularly as the ticks are emerging earlier each season due to climate change.
So until there is a vaccine available;
- cover up
- wear insect repellant
- check your clothing for ticks
- check children and pets for ticks
- remove ticks promptly with a tweezers
- if you think you have been bitten in a lyme prevalent are, contact your doctor as treatment is more effective is started early.