Pfizer starts a late-stage clinical trial

Pfizer has started a late-stage clinical trial to test a vaccine aimed at protecting against Lyme disease, the drugmaker announced Monday.

There are currently no vaccines approved in the United States for the tick-borne disease, which infects an estimated 476,000 people in the United States each year, according to the Centers for Disease Control and Prevention.

If Pfizer’s trial is successful, the vaccine could be the first human inoculation available for Lyme disease in the United States in two decades. Only one other vaccine against the disease, LYMERix, has been used in the country, but it was discontinued in 2002.

“With increasing global incidences of Lyme disease, it is more important than ever to offer a new option for people to protect themselves against the disease,” Annaliesa Anderson, Pfizer’s head of vaccine research and development, said in a statement.

Pfizer said it aims to enroll about 6,000 healthy adults and children 5 and older in the Phase 3 study, which will evaluate whether the vaccine is safe and effective.

The protein-based vaccine, called VLA15, is a three-dose regimen, administered over a period of five to nine months, followed by a booster dose 12 months later. It targets Borrelia burgdorferi, the bacteria that cause Lyme disease. The company is developing the vaccine together with the French biotechnology company Valneva.

Dr. Alan Kivitz, a Pennsylvania rheumatologist who is the trial’s principal investigator, said enrollment could be complete by the end of the year.

Pfizer said in its press release that it could potentially submit a vaccine application for approval to the Food and Drug Administration in 2025.

The trial comes as the incidence of Lyme disease appears to be increasing across the country.

Lyme disease diagnoses increased 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 focused on health care cost transparency. The findings come from an analysis of more than 36 billion privately billed health claims.

The bacteria that cause Lyme disease are carried by black-legged ticks; a bite from an infected tick can transmit the infection, according to the CDC.

Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center, attributed the increase in cases to more people living in urban areas traveling to areas where ticks are more prevalent.

He also said that as climate change brings warmer temperatures, the geographic areas where ticks can survive will expand, increasing the potential risk of Lyme disease.

Ticks have had a “significant population explosion,” he said.

Lyme disease can cause fever, headache, fatigue, and muscle and joint pain, according to the CDC. Most people will have a characteristic bullseye-shaped rash around the site of the tick bite. Currently, people infected with the disease can be treated with antibiotics.

If the disease is left untreated, people can experience long-term damage to their joints, heart and nervous system, Kivitz said.

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 United States, regions of the world where Lyme disease is highly endemic, according to the company.

Schaffner said there is “clearly” a need for a Lyme disease vaccine in the United States, especially in New England, where cases of the disease are higher than in other parts of the country.

In February, Pfizer announced that its vaccine had triggered an immune response in adults and children in a phase 2 study.

No side effects were reported, Kivitz said, but side effects can include pain at the injection site, muscle aches and fever.

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