Pfizer Preps Major Lyme Disease Vaccine Trial
A Lyme disease vaccine is finally in the works, and Pfizer is taking the lead in developing the biological preparation.
The New York City-headquartered pharmaceutical company announced Monday its plan to launch a large clinical trial of an experimental Lyme vaccine with its French partner, Valneva.
The researchers involved in the trial are seeking thousands of volunteers in the U.S. and Europe to test the vaccine — a major move against Lyme disease in 20 years, according to the Associated Press.
The two companies are eager to avoid the previous pitfalls in the development of a Lyme vaccine, so they want to come up with a preparation that would protect both adults and kids as young as 5 from the tick-borne illness.
The announcement comes amid the growing problem of Lyme disease cases that are said to be rising amid the warming weather. When the environment is warm, the bacteria responsible for the disease could spread because the ticks that serve as vectors expand their habitat.
In the U.S., about 476,000 people get treated for Lyme disease each year, based on data from the Centers for Disease Control and Prevention (CDC). On the other hand, Europe has about 130,000 yearly infections, per Pfizer.
It is worth noting that most people clear the infection through antibiotics when the disease is detected early. However, others suffer long-term symptoms because of damage to the nervous system or joints, as pointed out by CDC.
This wouldn’t be the first vaccine for Lyme. LYMErix used to be available in the U.S., but it was pulled off the market in 2002 over safety concerns and the lack of demand. People have since relied on bug sprays and tick checks for protection and prevention.
The new vaccine, VLA15, is administered in three primary doses followed by a booster. The trial will enroll 6,000 volunteers, including kids, from countries where Lyme is a problem. Half of them will receive a placebo for the three doses, while the other half will receive a placebo booster.
In the earlier trials, VLA15 showed “a strong immune response and satisfactory safety profile.” It is said to protect against six forms of protein expressed by the bacterial species present in Europe and North America, USA Today reported.
“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. We hope that the data generated from the Phase 3 study will further support the positive evidence for VLA15 to date,” Annaliesa Anderson, Pfizer's senior vice president and head of vaccine research & development, said in a statement