Pfizer Lyme disease vaccine fails trial, company to seek FDA approval
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Pfizer It said Monday it will seek regulatory approval for its Lyme disease vaccine candidate despite the vaccine’s failure in a late-stage trial.
Pfizer said the vaccine missed the trial’s statistical target because not enough people in the study had Lyme disease to trust the results. Still, the company said the vaccine reduced the infection rate in people who received it by more than 70% compared to a placebo; The company believes this activity is strong enough to be taken to regulatory authorities.
“The over 70% efficacy demonstrated in the VALOR study is extremely encouraging and creates confidence in the vaccine’s potential to protect against this potentially debilitating disease,” Pfizer Chief Vaccine Officer Annaliesa Anderson said in a statement. he said.
A vaccine for Lyme disease is not expected to become a best-selling product for Pfizer; The annual sales of the company’s partner Valneva are estimated to be 1 billion dollars. Pfizer expects overall revenue of about $60 billion this year, and its Covid-19 vaccine represents more than $5 billion of that estimate.
But Pfizer had touted its Lyme vaccine results as one of the key catalysts this year, representing a chance to deliver the only human vaccine for Lyme disease.
Moving forward with a vaccine that technically failed a clinical trial under an administration that preaches tighter scrutiny for vaccines could be risky for Pfizer, and could serve as a litmus test for vaccine policy in the United States.
Lyme disease is a disease caused by bacteria that are most commonly transmitted to humans from ticks. It can cause arthritis, muscle weakness and pain. Nearly half a million Americans are diagnosed with or treated for Lyme disease each year. predictions From the Centers for Disease Control and Prevention.
Despite the disease’s prevalence, especially in the Northeast, there is no vaccine available for humans. A company that will later GSK It launched a vaccine called LYMErix in 1998, but withdrew it just a few years later after concerns from the public about declining demand for safety. This experience disrupted the development of Lyme vaccines for humans, but many companies now produce these vaccines for dogs.
Pfizer and Valneva have faced setbacks of their own. Companies in 2023 fell About half of the participants in the Phase 3 trial withdrew due to quality concerns with third-party clinical trial site operator Care Access. About 18,000 people initially participated in the trial, and after cuts it ended up being about 9,400 people.
The company’s vaccine targets the outer surface protein A of the bacteria that causes Lyme disease. The vaccinated person creates antibodies that pass to the tick, preventing the bacteria from passing from tick to human. The series includes three shots in the first year, followed by a booster dose the following year.
The companies said they did not observe any safety concerns in the trial.
