A new vaccine is likely to become available for Lyme disease, which can cause pain and fatigue for months even if diagnosed early on, and can cause lifelong problems if not detected until it is too late. Lyme disease is caused by tick bites transmitting the bacterium Borrelia burgdorferi. Although most cases of Lyme disease can be cured with a 2- to 4-week course of oral antibiotics, patients can sometimes have symptoms of pain, fatigue, or difficulty thinking that lasts for more than 6 months after they finish treatment.
Every year, Lyme disease affects over 500,000 people in the United States. It manifests itself as a rash, fever, chills, headaches, fatigue, or muscle and joint aches, and mild stiffness in the neck.
Although this disease can be easily treated with antibiotics if detected in the early stages, untreated Lyme can affect the joints and heart leading to oligoarticular arthritis and carditis, respectively. Brain injuries from untreated Lyme include facial palsy, meningitis, athritis and nerve pain.
The distribution of previous Lyme disease vaccines was discontinued due to lawsuits by ambulance-chasing trial lawyers, over concerns about potential autoimmune arthritis induction following vaccination; however, no evidence was found for this safety concern. (Similar vaccines are still available for your dog.
A recent study found that the hexavalent VLA15 vaccine is safe and effective against Lyme disease. Vaccination, which involved three doses of the vaccine, was safe and well-tolerated by the healthy adult human population in the study. VLA15 also triggered significant immune responses against all six serotypes based on OspA.
The vaccine was found to be safe, and did not induce any serious systemic or local adverse reactions. Some mild systemic and local adverse reactions such as tenderness and pain in the injection site, as well as myalgia, fatigue, and headache, were observed. However, no adverse reactions similar to manifestations of Lyme disease, or any evidence of systemic inflammation, were detected (that includes changes in biomarkers such as C-reactive protein, leukocytes, and erythrocyte sedimentation rates).
Booster vaccination 13 months following the first vaccine dose was equally safe and was effective, in that it induced substantial anamnestic immune responses. The observed reactions to the VLA15 vaccine were typical of the adverse reactions to other safe and effective lipid-formulated recombination vaccines.
The fact that this vaccine was found by a study to be safe and effective does not mean it will be instantly made available to the public. It needs to be approved by the FDA before it can be sold, which will take a while. FDA employees commonly take years to approve life-saving drugs and diagnostic tools.The FDA didn’t approve a home test for HIV until 24 years after it first received an application. According to an FDA advisory committee, the test held “the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone.” That means thousands of people likely got infected with AIDS as a result of the delay in approving it. As Roger Parloff of Fortune notes, the FDA’s delay in approving the home HIV test was a “scandal.” It likely caused the deaths of thousands of people, given the high mortality rate from AIDS in the past.
The FDA’s slowness in approving drugs and devices results in the deaths of hundreds of thousands of people who could have been saved by earlier approval of those drugs. For example, at least a hundred thousand people died waiting for the FDA to approve beta blockers.
