Pfizer begins late-stage clinical trial

Pfizer has started a late-stage clinical trial to test a vaccine that aims to protect against Lyme disease, the drugmaker announced Monday.

There are currently no vaccines approved in the United States for the tick-borne disease, which infects about 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, was used in the country, but it was discontinued in 2002.

“With rising global rates of Lyme disease, it is more important than ever to give people a new option to protect themselves against the disease,” said Annaliesa Anderson, head of vaccine research and development at Pfizer, in a statement.

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

The protein-based vaccine, called VLA15, is a three-dose regimen, given over five to nine months, followed by a booster dose 12 months later. It targets Borrelia burgdorferi, the bacteria responsible for Lyme disease. The company is developing the vaccine with French biotech company Valneva.

Dr. Alan Kivitz, a rheumatologist in Pennsylvania and 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 Food and Drug Administration approval in 2025.

The trial comes as the prevalence of Lyme disease appears to be rising across the country.

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. non-profit organization focused on healthcare cost transparency. The findings come from an analysis of more than 36 billion privately billed healthcare claims.

Bacteria that cause Lyme disease are carried by blacklegged 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 rise 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 regions in which ticks can survive will expand, increasing the potential risk of Lyme disease.

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

Lyme disease can cause fever, headaches, fatigue, and muscle and joint pain, according to the CDC. Most people will have a characteristic bubble-like 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 joints, hearts and nervous systems, Kivitz said.

Pfizer’s Lyme disease vaccine, which received fast-track designation from the FDA in 2017, is the only such vaccine in clinical development, according to the company.

The trials will take place in Finland, Germany, the Netherlands, Poland, Sweden and the United States, areas 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. country.

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

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

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