FDA quells Care Access misconduct concern in Pfizer’s Lyme disease vaccine trial

The US Food and Drug Administration (FDA) has found no misconduct by contract research organisation (CRO) Care Access in Pfizer and French partner Valneva’s Lyme disease vaccine trial.

The FDA did not issue a Form 483 – a document sent to a company indicating violations after an inspection.

The outcome comes after a nine-day for-cause FDA Good Clinical Practices (GCP) inspection into sites managed by Care Access in Pfizer’s VALOR trial. The inspection reviewed Care Access’s contributions to the trial, including GCP requirements, patient safety and data integrity, the CRO said in an 11 October statement.

Care Access CEO Ahmad Namvargolian said in a company statement: “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.”

In February 2023, Pfizer and Valneva announced it was halting testing its VLA15 vaccine in approximately half of the total recruited patients in the Phase III trial at sites run by a third-party contractor due to GCP violations.

At the time, the two companies did not disclose the name of the contractor running the sites, but Care Access released a statement soon after rejecting the claims. In the statement announcing the FDA outcome, Care Access said the discontinuation meant 3,000 participants left the trial. The trial’s total anticipated enrolment is 18,000 participants, as per its ClinicalTrials.gov entry (NCT05477524).

Due to the complications, Pfizer and Valneva now expect to submit a biologics license application to the FDA and a marketing authorisation application to the European Medicines Agency in 2026, a year later than planned.

In a Q1 2023 earnings report, Valneva said Pfizer has continued to enrol new participants to make up for the drop in numbers and has added new sites in the US and Canada. Currently enrolled participants will receive a booster vaccination as planned in Q2 2024 ahead of spring and summer when ticks are most active, with overall trial continuation up to the 2025 tick season.

Pfizer and Valneva teamed up to co-develop and commercialise VLA15 in April 2020. It is the most clinical trial-advanced Lyme Disease vaccine, with Moderna’s two mRNA vaccine candidates in Phase I/II trials, according to GlobalData’s clinical trial database.

Previously, a vaccine called Lymerix was available until 2002 when its manufacturer SmithKline Beecham withdrew it due to insufficient customer demand.

VLA15 is a highly anticipated vaccine for Lyme disease treatment due to its multivalent design. It can target six different types of borrelia bacteria that cause the disease, which is passed from ticks to humans.