Pfizer, Valneva Hit An Ethics Roadblock In Testing For Lyme Disease

(CTN News) – The stock price of Valneva (VALN) plummeted Friday after Pfizer (PFE) announced that approximately half of the study participants would be removed from the trial.

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The decision follows Pfizer’s discovery of violations of “acceptable clinical practice” rules at study sites operated by a third party.

Clinical studies are governed by these rules to ensure that ethical and scientific standards are maintained. The decision was not prompted by side effects or safety concerns with the vaccine, according to Pfizer and Valneva.

As a result, Pfizer and Valneva may be behind schedule in enrolling the 18,000 participants required for the test. In addition to a fever, headache, fatigue, and a skin rash, Lyme disease is transmitted by tick bites.

It can lead to the spread of the disease to the heart and the nervous system if left untreated.

The companies stated in a written statement that upon learning of potential GCP violations, Pfizer reviewed the operations and data collection at the clinical trial sites run by the third party and followed standard operating safeguards in order to determine the appropriate course of action.

During today’s stock market session, Valneva stock fell 7.6% and closed at 12.62. On the other hand, Pfizer stock rose slightly, ending the regular session at 43.21.

The stock of Valneva has reached its 50-day high

An experimental Lyme disease vaccine called VLA15 was developed by Pfizer and Valneva in 2020 as part of a $308 million collaboration deal.

Additionally, Valneva is eligible to receive tiered royalties on sales beginning at 19%. With an investment of $95 million in Valneva stock in June of last year, Pfizer doubled down on its bet.

After that, the companies began a Phase 3 study of Lyme disease in the third quarter. They aim to enroll 18,000 participants across multiple countries in areas where Lyme disease is prevalent.

In addition, participants should have lifestyles that place them at a heightened risk of contracting Lyme disease, such as working outdoors or engaging in recreational hiking.

According to Clinicaltrials.gov, they intend to enroll patients by the end of 2024. Pfizer still plans to submit approval requests in the United States and Europe in 2025.

However, Valneva’s stock price plummeted after the news on Friday.

As they stated in their statement, “Integrity of data collected from clinical trials is critical to determining the safety and efficacy of a potential vaccine or medicine.”

Valneva and Pfizer are committed to collecting robust data needed for potential regulatory submissions of VLA15.

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