If the trial succeeds, the vaccine could be the first human immunization for Lyme disease in the U.S. in two decades, reports American broadcast television network NBC News.
Pfizer has started a late-stage clinical trial to test a vaccine that aims to protect against Lyme disease, the drugmaker announced Monday, August 8.
According to the Centers for Disease Control and Prevention, there are currently no vaccines approved in the United States for the tick-borne illness, which infects an estimated 476,000 people in the U.S. each year.
If Pfizer’s trial succeeds, the vaccine could be the first human inoculation available for Lyme disease in the U.S. in two decades.
Only one other vaccine for the disease, LYMErix, has been used in the country, but it was discontinued in 2002.
«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,» Annaliesa Anderson, Pfizer’s head of vaccine research and development, said in a statement.
Pfizer said it aims to enroll approximately 6,000 healthy adults and children 5 and older in the phase 3 trial, which will evaluate whether the vaccine is safe and effective.
The protein-based vaccine, called VLA15, is a three-dose regimen, administered over a five-to-nine month period, followed by a booster dose 12 months later.
It targets Borrelia burgdorferi, the bacteria that cause Lyme disease. The company is developing the vaccine with French biotech firm Valneva.
Dr. Alan Kivitz, a rheumatologist in Pennsylvania who is a principal investigator for the trial, said that enrollment could be completed by the end of the year.
Pfizer said in its news release that it could potentially submit a vaccine application for approval to the Food and Drug Administration in 2025.
Lyme disease diagnoses rose 357% in rural areas and 65% in urban areas from 2007 to 2021, according to an analysis of private insurance claims released this month by FAIR Health, a nonprofit organization focused on health care cost transparency. The findings come from an analysis of more than 36 billion privately billed health care claims.