Valneva, the French vaccine maker, and Pfizer said Thursday following phase 2 safety trials that the Lyme disease vaccine candidate will produce long-lasting protection.
The phase 2 trial was completed in April, and six months later, the company looked at antibody levels in children and adults who received the vaccine two or three times.
The company found that antibodies remained higher in the three-shot group compared to the two-shot group.
Although these antibodies declined over time, they showed long-lasting protection against Lyme disease. The company has not reported any side effects or safety issues and is now in the middle of phase 3 clinical trials.
Lyme disease is a bacterial infection spread by ticks. Its symptom is a rash that resembles a bull’s eye near the bite site, but symptoms can include fever, chills, joint pain, and headache.
If not treated early, it can lead to heart disease – inflammation of the heart – or arthritis. Some people may have symptoms for a long time after treatment, a condition called post-treatment Lyme-disease syndrome.
The Lyme vaccine was released on the market 20 years ago
There is already a US Food and Drug Administration approved vaccine for Lyme disease. GSK – known as SmithKline Beecham – developed a Lyme vaccine that was approved by the FDA in 1998. Called Lymerix, it was about 75 percent effective in preventing Lyme after three shots.
But at the time, the Centers for Disease Control and Prevention did not recommend the vaccine because the disease was seen as easily treatable in its early stages.
In addition, patients did not want to receive the vaccine because they found the dosing schedule difficult, and it was not approved for children because it had not been tested in that group.
It was pulled from the market in 2002 after patients reported it caused serious side effects such as arthritis and filed a class action lawsuit.
The CDC and FDA did not find a way to have a vaccine to cause this, but that did not save Lymerix. Sales declined so much that GSK pulled the drug from the market.
Valneva and Pfizer hope that the new Lyme vaccine will be well received by the public. If the results of the phase 3 study are good, the company wants to get FDA approval for this vaccine in 2025.
Lyme disease is a growing problem
Lyme disease has been a major concern since 2002. According to the CDC, about 30,000 cases are reported each year, although the agency says this is a much smaller number than the actual number of people who become ill. This compares to about 24,000 cases reported in 2002.
A study using private insurance data estimates that approximately 476,000 patients were diagnosed with Lyme disease between 2010 and 2018.
In 2022, research showed that 15 percent of the world’s population will have contracted Lyme disease at some point in their lives.
One hypothesis for the increased spread of Lyme in the American Northeast involves the rise of dense forests, which lead to a specific type of mouse harboring the bacteria that causes Lyme.
Additionally, climate change is increasing the number of disease-carrying ticks because warmer temperatures can accelerate the tick’s lifespan and make it more likely to survive the winter.
This article was originally published by Business Insider.
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