Thomas Fuller | Photo only | Getty Images
Pfizer On Monday, the company said it would seek regulatory approval for a Lyme disease vaccine candidate, even though the shot failed in a late-stage trial.
Pfizer said the vaccine missed the study’s statistical target because not enough people in the study had Lyme disease to rely on the results. Still, the company said the shot reduced the infection rate by more than 70% in people who received the vaccine compared to placebo. The company believes the effectiveness is strong enough to report to regulators.
“The greater than 70% efficacy shown in the VALOR study is extremely encouraging and provides confidence in the vaccine’s potential to protect against this disease, which can be debilitating,” Pfizer Chief Vaccines Officer Annaliesa Anderson said in a statement.
A Lyme disease vaccine is not expected to be a bestseller for Pfizer. Corporate partner Valneva estimates peak annual sales at $1 billion. Pfizer expects total sales of around $60 billion this year, with the Covid-19 vaccine accounting for more than $5 billion of that forecast.
But Pfizer had cited the Lyme disease vaccine results as one of its key catalysts this year, and they represented an opportunity to introduce the only human vaccine against Lyme disease.
Advancing a shot that technically leaves a clinical trial doomed to failure under an administration that has preached tighter control of vaccines could prove risky for Pfizer and could serve as a litmus test for vaccination policy in the United States
Lyme disease is a disease caused by bacteria that are most commonly transmitted to humans by ticks. It can cause arthritis, muscle weakness and pain. The Centers for Disease Control and Prevention estimates that about half a million Americans are diagnosed or treated for Lyme disease each year.
Despite the spread of the disease, particularly in the Northeast, there is no vaccine for humans. A company that would later become GSK introduced a vaccine called LYMErix in 1998, but withdrew it just a few years later after public concerns about safety fueled demand. This experience hindered the development of Lyme vaccines for humans, although several companies now make them for dogs.
Pfizer and Valneva suffered their own setbacks. In 2023, the companies withdrew approximately half of the Phase 3 trial participants due to quality concerns with the third-party clinical trial site operator, Care Access. Initially around 18,000 people were involved in the study, but after the cuts there were ultimately around 9,400.
The companies’ vaccine targets the outer surface protein A of the bacteria that causes Lyme disease. A vaccinated person produces antibodies that are passed on to a tick and prevent the bacteria from being transmitted from the tick to humans. The series includes three vaccinations in the first year and then a booster dose the following year.
The companies said they found no safety concerns with the trial.
Choose CNBC as your preferred source on Google and never miss a moment from the most trusted name in business news.
