Pfizer and French biotech company Valneva are launching a clinical trial to test the only current vaccine candidate against Lyme disease, the companies announced Monday.
Why it matters: The study could result in the first possible vaccine against the disease in two decades. Almost half a million people may get Lyme disease in the U.S. each year, according to the CDC.
- The only Lyme disease vaccine previously marketed in the U.S. was discontinued in 2002 due to "insufficient consumer demand," per the CDC.
By the numbers: Nearly 36,000 confirmed and probable cases of Lyme disease were reported in the U.S. in 2019 — but the CDC suspects the actual number of cases each year could be about 476,000.
- Between 1997 and 2019, the amount of confirmed Lyme disease cases increased by 54%, the CDC found.
- Diagnosing the disease can be difficult, and there isn't a reliable test for detecting it early on, when treatment with antibiotics is most effective.
The big picture: Ticks, which are now more abundant than usual, spread bacteria that causes Lyme disease along with more than a dozen other pathogens.
- Researchers attribute the increase in ticks to rising temperatures from climate change, which lead to longer summers and shorter winters, in turn impacting animal migration.
What they're saying: “With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important than ever,” said Annaliesa Anderson, head of vaccine research at Pfizer, in a news release.
Details: Researchers at Pfizer and Valneva are seeking 6,000 volunteers in the U.S. and Europe for phase 3 trials of the vaccine, which is called VLA15.
- The study will enroll volunteers ages 5 and older at 50 sites in areas where Lyme disease is highly endemic, including the U.S., Finland, Germany, the Netherlands, Poland and Sweden.
- Volunteers will get three shots, either the vaccine or a placebo, between now and next spring’s tick season. They’ll get one booster dose a year later.
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