- Clinical trial contractor Care Access on Tuesday said an inspection by the Food and Drug Administration found no evidence of misconduct in a large trial the group helped run of Pfizer and Valneva’s experimental Lyme disease vaccine.
- In February, Pfizer and the French vaccine maker said they were removing half of the Phase 3 study’s participants due to concerns about violations committed by a “third-party clinical trial site operator.”
- The move pushed the companies’ timeline for when they expect to submit an approval application to 2026 from previous expectations of 2025. According to Pfizer, the vaccine is the only Lyme disease shot in clinical development. The disease, which is transferred by tick bites, can be treated with antibiotics if caught in time but can cause severe health problems.
Care Access had disagreed with Pfizer and Valneva’s decision to remove more than 3,000 participants from the study over alleged violations of Good Clinical Practice, an international ethical and scientific standard clinical researchers must follow during trials.
Care Access on Tuesday said the FDA’s investigation, which lasted from Oct. 2 through Oct. 10, resulted in no violations, so-called Form 483 observations.
“We’re very glad to have had the opportunity finally to undergo this independent, searching review by an FDA expert, which confirmed what we’ve always said about our performance on the VALOR trial and beyond,” said Care Access CEO Ahmad Namvargolian, in a statement.
The Phase 3 study, dubbed VALOR, is still ongoing at other sites not operated by Care Access. Pfizer has begun to enroll new trial participants to replace those that were removed from the study.
So far in clinical testing, the vaccine candidate has produced, among both children and adults, high levels of antibodies against the six strains of Lyme disease.
Another vaccine for Lyme disease, called Lymerix, was previously available, until its developer GSK discontinued it in 2002 due to low demand and concerns of side effects.