Pfizer and Valneva, a French pharmaceutical company, announced they are recruiting approximately 6,000 people for a late-stage clinical of a vaccine meant to protect against Lyme disease.
Participants will include adults and children aged five and older in "highly endemic" regions in Europe and the U.S. for Lyme disease, the drugmaker said. Candidates will receive doses of a VLA15, or a placebo, along with a booster dose or additional placebo.
"With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important," Annaliesa Anderson, Pfizer's vaccine development chief, said in a statement on Monday. "We hope that the data generated from the Phase 3 study will further support the positive evidence for VLA15 to date, and we are looking forward to collaborating with the research sites across the U.S. and Europe on this important trial."
If Pfizer's and Valneva vaccine development succeeds, the vaccine could become human inoculation approved federally in the U.S. for Lyme disease since Lymeriz was discontinued in 2002.
Currently, the United States does not have an approved vaccine for the illness. The Centers for Disease Control and Prevention estimates that more than 450,000 are infected by Lyme disease every year.
The company estimates they may be able to submit the vaccine for approval in the U.S. and Europe by 2025 if Phase 3 of the vaccine trial is successful. Pfizer vowed to pay Valneva $25 million if the Phase 3 study is initiated.
The CDC notes that early symptoms of Lyme Disease could include fever, headaches, fatigue, rashes, and swollen lymph nodes. A severe case of the illness can result in Bell's palsy or joint damage and can be fatal in rare circumstances.
Pfizer noted, "The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens."