Pfizer has started a late-stage clinical trial to test a vaccine that will protect against Lyme disease, the drugmaker announced Monday.
There are no vaccines approved in the United States for the tick-borne illness, which infects approximately 476,000 people in the US each year, according to the Centers for Disease Control and Prevention.
If Pfizer's trial succeeds, the vaccine could be the first human inoculation available in the U.S. for Lyme disease 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 Lyme disease, providing a new option for people to protect themselves from the disease is more important than ever, according to Annaliesa Anderson, Pfizer's head of vaccine research and development.
Pfizer hopes to enroll approximately 6,000 healthy adults and children 5 and older in the Phase 3 trial, which will determine whether the vaccine is safe and effective.
A booster dose 12 months later, the protein-based vaccine, called VLA 15, is a three-dose regimen that is administered over a five to nine month period. 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 enrollment could be completed by the end of the year.
Pfizer said in its news release that it could submit a vaccine application to the Food and Drug Administration in 2025.
The prevalence of Lyme disease appears to be growing across the country, as a result of the trial.
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 were based on an analysis of more than 36 billion privately billed health care claims.
The CDC says that the Lyme disease is carried by black-legged ticks, and a bite from an infected tick can transmit the infection.
The rise in cases is due to more people living in urban areas moving to areas where ticks are more prevalent, according to Dr. William Schaffner, an infectious diseases specialist at Vanderbilt University Medical Center.
He said that as climate change brings warmer temperatures, the geographic regions in which ticks can survive will expand, increasing the potential risk for Lyme disease.
He said that ticks have had a significant population explosion.
Lyme disease can cause fever, headaches, fatigue and muscle and joint aches, according to the CDC. The majority of people will have a characteristic bullseye-shaped rash around the site of the tick bite. People who are infected with the disease can be treated with antibiotics.
Kivitz said that if the disease is left untreated, people can experience long-term damage to their joints, heart and nervous system.
Pfizer's Lyme disease vaccine, which was granted fast track designation by the FDA in 2017 is the only vaccine of its kind in clinical development, according to the company.
Trials will take place in Finland, Germany, the Netherlands, Poland, Sweden and the U.S. regions of the world where Lyme disease is highly endemic, according to the company.
Schaffner said there was a need for a vaccine against Lyme disease in the U.S. particularly in New England, where cases of the disease are higher than in other parts of the country.
In February, Pfizer announced that it had triggered an immune response in adults and children in a phase 2 trial.
Kivitz said no adverse reactions were reported, but side effects can include pain at the injection site, muscle aches and fever.