We spoke in my last post about Lyme disease, what it is, how to understand it, and what we can do about it. I decided to write this post because another friend of mine who has been having a huge amount of problems just discovered that the source of her issues was Lyme. That makes quite a few people that I know who suffer incredibly bad symptoms as a result of the disease. Luckily it’s not incredibly prevalent where I live but it migrates further north every year. One of the things that people often wonder about regarding the disease is why there is no available vaccine. The actual answer to that query is rather complicated.
Something that few younger people realize is that in the early 90s there was a vaccine available for the disease. LIMErix, developed by SmithKline Beecham. The product was released as a three dose vaccine that was found to be 76-92 % effective preventing the disease after transmission. Thats sounds incredible right? Well it wasn’t to be.
A very short period of time after its release, LIMErix fell under scrutiny. Small numbers of people who received the vaccine were reporting side effects. The media picked up on the reports and the company fell under a great deal of scrutiny. In 1999, 121 people joined arms together and filed a lawsuit against the company. They claimed that they had developed arthritis as a result of the vaccine. Around the same time there was a report circulating around that a different vaccine had been linked to autism. This was later proved false but a great deal of damage was done to many vaccines during this time.
In 2002 the company reported that their sales of LIMErix had fallen from 1.5 million doses in 1999 to an anticipated 10,000 doses for that year. The company eventually caved to the media pressure and the lack of sales and pulled the vaccine from the shelves.
Around this time the anti-vaccine movement was taking hold and it didn’t help the situation for LIMErix.
After the company pulled the vaccine, the F.D.A conducted their own testing to certify or dispute the lawsuit. They were unable to replicate the side effects that the lawsuit reported. Despite this, the company settled the lawsuit out of concern for public image. The claimants received no compensation but the settlement did give 1 million dollars in legal fee compensation. Despite it still being approved and licensed in the United States and despite studies to refute the claims of side effects, e company has never reintroduced LYMErix.
However, there is light at the end of the tunnel. In 2017, the FDA approved a Fast Track designation for a new Lyme disease vaccine. Valneva, a French company developed VLA15, a Lyme disease vaccination and the drug has completed its initial trials. In December of 2018 the company announced that they were beginning phase 2 of their testing with FDA approval. Pre-clinical data showed that VLA15 has the potential for protection against Borrelia.
The purpose of Phase 2 is to evaluate what the highest effective and safe dose of the vaccine is, they will also most likely test a three part dose. This phase is expected to take 2 years to complete. Phase 3 will include field testing before the drugs hopeful release. You can find the latest press release here.