French biotech firm Valneva, who have been developing a preventative vaccine for Lyme disease, announced last week that the FDA gave them permission to start clinical trials of the treatment- on people. The European Union’s Clinical Trial Application also gave similar permission.
Though LYMErix was released in 1998 and was nearly 80% effective, SmithKline Beecham (now GlaxoSmithKline) stopped selling the vaccine in 2002 because of a lawsuit which they eventually settled out of court. At issue were the severe adverse reactions, which included Lyme disease-like symptoms. Not surprisingly, an “extensive” follow-up study was done and found that the vaccine was totally normal.
Every year about 300,000 new Lyme disease cases are reported in the U.S. and about85,000 cases are reported in Europe (according to the CDC). And according to a recent study, it costs more than $1 billion a year (in the US alone) in healthcare costs to treat.
And because we are losing the prevention battle, the vaccine makes sense to so many.
What is Lyme disease
Lyme disease, which is spread by ticks, is caused by a bacteria called Borrelia.
For those infected with Borrelia, serious symptoms can develop: rheumatoid arthritis-like joint and muscle pain, fatigue and neurological disorders (think numbness, tingling, weakness) and cognitive impairment – can set in too.
The best way to currently treat the disease is two to four weeks’ of antibiotics (normally doxycycline or amoxicillin) within a few days of infection – but that only works IF you know you’ve been bitten and the longer you go without treatment, the more serious your symptoms can be. Also, because Lyme can look like other things, doctors don’t always think to order a Lyme test. This is why Lyme is sometimes called the “great imitator” or “great masquerader.”
If infections are left untreated they can lead to brain inflammation or heart problems- infections don’t go away on their own and neither do symptoms.
However, just because the vaccine is approved for a clinical trial doesn’t guarantee it will be safe and effective in people.
From the article:
“The FDA granted a phase 1 clinical trial of the vaccine, which means it’s being evaluated for safety – not how effective it is, or if it even works at all. Still, it’s an important test that relatively few proposed treatments undergo.
If the phase 1 trials show the vaccine is safe to use in people, it will have to clear two other hurdles before Valneva could sell and market it: a phase 2 trial, which would test how well it works in preventing cases of Lyme disease, and a phase 3 trial, which more broadly tests effectiveness by using different dosages on larger and more diverse populations.”
Getting a treatment all the way through phase 3 trials can cost more than a billion dollars and about 86% won’t pass the final two stages. (And 94% of all drugs that pass animal trials fail to pass in human clinical trials.)
Valneva’s new vaccine, VLA15-101, is based on the now-defunct (but FDA-approved) LYMErix vaccine: by injecting people with an outer surface protein of Borrelia, called OspA, the body’s immune system could recognize the bacteria and launch an attack if they showed up after a bite from an infected tick.
However, the protein in US Borrelia is different than that of the European species of the bacteria. And they even differ from one region to another- there are six different types. Since the LYMErix vaccine didn’t address that issue, Valneva based their vaccine on all different kinds of OspA to cover US and European strains of Borrelia.
The phase 1 trial will be tested on 180 adults at a US site and one in Belgium.
Remember, the best thing you can do for yourself is to be vigilant. Make sure to wear the proper clothes when you are in areas where ticks may be and do proper checks when you get in.
Source: Business Insider