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pfizer The country’s government announced Monday that it will seek regulatory approval for a Lyme disease vaccine candidate despite it failing late-stage trials.
Pfizer said the vaccine failed to meet the trial’s statistical goals because not enough people with Lyme disease participated in the study to have confidence in the results. Still, the company said its vaccine reduced infection rates by more than 70% in vaccinated people compared with a placebo, and the company believes its efficacy is strong enough to appeal to regulators.
“The greater than 70% efficacy demonstrated in the VALOR study is extremely encouraging and gives confidence in the vaccine’s potential to prevent this potentially debilitating disease,” Annalisa Anderson, Pfizer’s chief vaccine officer, said in a statement.
The Lyme disease vaccine is not expected to be a bestseller for Pfizer, whose partner Valneva estimates annual sales at its peak at $1 billion. Pfizer projects overall revenue of about $60 billion this year, with its coronavirus vaccine accounting for more than $5 billion of that forecast.
But Pfizer has been touting the results of its Lyme disease vaccine as one of the main catalysts this year, arguing that it presents an opportunity to introduce the only human vaccine against Lyme disease.
Advancing development of a vaccine that technically failed clinical trials under an administration that preaches strict vaccine oversight could be a risk for Pfizer and could serve as a litmus test for U.S. vaccine policy.
Lyme disease is a disease caused by bacteria that is most commonly spread to humans from ticks. It can cause arthritis, muscle weakness, and pain. The Centers for Disease Control and Prevention estimates that approximately 500,000 Americans are diagnosed with or treated for Lyme disease each year.
Despite the disease’s prevalence, especially in the Northeast, there is no vaccine for humans. company after GSK The company introduced a shot called LYMErix in 1998, but it was discontinued just a few years later as demand declined due to public concerns about its safety. This experience hindered the development of a Lyme vaccine for humans, but multiple companies now produce vaccines for dogs.
Pfizer and Valneva have each faced setbacks. In 2023, the companies withdrew about half of the participants from a Phase 3 trial, citing quality concerns with third-party clinical trial site operator Care Access. The trial initially enrolled about 18,000 people, but after cuts, the final number was about 9,400. Care Access denied the allegations of quality violations.
The company’s vaccine targets protein A on the outer surface of the bacteria that causes Lyme disease. Vaccinated people produce antibodies that are transmitted to ticks and prevent them from transmitting bacteria to humans. In this series, three vaccinations are given in the first year, followed by a booster vaccination in the following year.
The companies said the trials found no safety concerns.
