Pfizer and Valneva’s Clinical Trial on the Brink of Disaster Due to Possible Regulatory Breaches

Pfizer and Valneva have dealt a major blow to the development of their Lyme disease vaccine candidate, VLA15, after they uncovered potential violations of good clinical practice (GCP) standards, resulting in the withdrawal of nearly half of the enrolled participants in their Phase III VALOR study. This setback has cast a pall over hopes that the vaccine would soon be available to help protect against the debilitating condition.

Pfizer has reported that the discontinuation of participants from its Covid-19 vaccine trial was due to study conduct violations, rather than safety concerns or adverse events. Spokesperson Kit Longley reassured that there is no cause for alarm, and the vaccine remains safe.

GCP (Good Clinical Practice) sets the gold standard for clinical research, dictating the internationally-recognised ethical and scientific benchmarks that must be achieved in order to ensure trials are of the highest quality and integrity. Adherence to GCP standards is vital in order to guarantee research is conducted responsibly and with respect for participants.

Pfizer launched a thorough investigation after learning of potential violations at clinical sites in the U.S. run by a third-party clinical trial site operator. Upon completion of the review, they promptly notified affected participants, the FDA, and other regulatory bodies, as well as VALOR’s independent Institutional Review Board. Taking these actions ensured that the incident was addressed and managed appropriately.

The VALOR clinical trial continues to enroll patients, with over 7,000 already involved in the study. Although potential Good Clinical Practice violations have been identified at some clinical sites, the trial is ongoing at other centres, ensuring the pursuit of valuable medical research.

Pfizer and Valneva are collaborating with the FDA and other regulatory authorities like the European Medicines Agency to refine the clinical trial plan for VLA15. With their combined efforts, they are aiming to complete Phase III studies and submit a Biologics License Application for the candidate by 2025. It is an ambitious project that could have a lasting impact on the healthcare industry.

One of a Kind

VLA15 is an exciting and revolutionary vaccine currently in clinical development, designed to protect against Lyme disease. This multivalent shot works by blocking the transmission of Borrelia burgdorferi, the bacteria responsible for the disease, from its tick vector to humans. By targeting six of the most common serotypes of the OspA protein found on the bacteria, VLA15 is the only Lyme disease vaccine currently in development, providing a much needed line of defense against this debilitating infection.

In 2017, the FDA granted Valneva’s candidate vaccine, VLA15, its Fast Track designation, recognizing its potential to provide powerful protection against the Borrelia species known to cause human illnesses. VLA15 was originally discovered by Valneva, demonstrating the promise it holds for a much-needed immune defense against these dangerous pathogens.

In April 2020, Pfizer made a major move into the Lyme vaccine market, striking a deal with Valneva for the potential co-development and commercialization of the VLA15 vaccine. Worth a total of $308 million, the agreement includes a $130 million upfront payment, as well as additional development and commercialization milestones of $35 million and $143 million, respectively.

Pfizer and Lyme Disease: A Partnership for Progress. In August 2022, Pfizer launched a groundbreaking VALOR trial—a randomized and placebo-controlled study with up to 50 sites in areas of high Lyme disease endemicity, such as the U.S., Sweden and Germany. This trial is part of an agreement where Pfizer takes the lead in late-stage development, aiming to make advances in Lyme disease treatment.

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