Your future consultant
Patients are regularly treated with antibiotics such as doxycycline. But a new drug from Pfizer and French pharmaceutical company Valneva could be the next (and only) Lyme disease vaccine available in the United States. Drug brands have introduced a latest human clinical trial for their vaccine candidate, VLA15. If the phase 3 study is successful, the companies said they plan to seek approval from the U. S. Food and Drug Administration. In the U. S. in about three years.
“With the emerging global rates of Lyme disease, it is more vital than ever to offer other people a new option for themselves of the disease,” Annaliesa Anderson, head of vaccine and progression studies at Pfizer, said in a statement.
Here’s what you want to know about VLA15 and Lyme disease, plus how it works, how it will be evaluated, and when it will be approved.
To learn more about COVID vaccines, here’s what you want to know about this fall’s COVID-19 vaccine booster and where you can get your kids the COVID vaccine.
A classic “porthole” rash through Lyme disease.
Lyme disease, or borreliosis, is a bacterial infection that is transmitted to humans through the bite of a tick carrying the bacterium Borrelia burgdorferi.
Notable for its revealing bull’s eye rash, Lyme disease is the most prevalent insect-borne disease in the Northern Hemisphere. of global warming,” Dr. James Marvel, a wild medicine expert at Stanford Health Care, told Crumpe because it creates a more tick-friendly environment.
The first symptoms of Lyme disease are ignored or misunderstood, which gives time for more severe headaches to appear.
“The medical need for vaccination against Lyme disease is expanding as the geographic footprint of the disease expands,” Pfizer said in a statement.
Read more: How to remove ticks and save yourself from Lyme disease
The FDA had in the past approved a vaccine against Lyme disease called Lymerix in 1998. Manufactured through SmithKline Beecham (now GlaxoSmithKline), Lymerix has reduced new infections in adults by nearly 80 percent, according to the journal Epidemiology and Infection.
But some patients have testified that they later developed arthritis. Even though an FDA investigation did not show a link, media reports about the allegations led to a decline in use and sales at the time. Lymerix was withdrawn from the market in 2002 after only 3 years.
There has been no vaccine for Lyme disease since 2002, when Lymerix was withdrawn from the market.
VLA15 earned FAST Track designation from the FDA in July 2017.
If the most recent human trials are successful, Pfizer and Valneva will seek approval from the FDA and the European Medicines Agency in 2025.
VLA15 targets the outer surface protein (OspA) of Borrelia burgdorferi, the Lyme disease bacterium.
“Blocking OspA inhibits the bacteria’s ability to leave the tick and infect humans,” according to the news release.
Pfizer, which co-developed a COVID-19 vaccine with BioNTech, reports that VLA15 has demonstrated “a strong immune reaction and an acceptable protection profile” in preclinical and clinical trials.
Although VLA15 works for Lymerix, it omits a protein region “that some have attributed to adverse events,” according to the National Institute of Allergy and Infectious Diseases, NPR reported.
Approximately 6,000 participants over the age of five will be enrolled at up to 50 sites in countries where Lyme disease is endemic, the United States, Finland, Germany, the Netherlands, Poland, and Sweden.
Research subjects will get 3 microgram doses of VLA15 or a placebo, followed by a booster dose.