Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15

Mij · Aug 9, 2022

https://www.pfizer.com/news/press-r...d-valneva-initiate-phase-3-study-lyme-disease

RedFox · Aug 10, 2022

Lyme is a nasty infection so hopefully this works and doesn't go the way of Lymerix. I got a pretty bad case many years ago. There was no rash and the symptoms came one after another rather than all at once, so it took a month or two for me to realize I needed to go to the doctor.

Sly Saint · Feb 17, 2023

Pfizer removes HALF of patients from its Lyme disease vaccine trial

Pfizer is removing half of patients from its Lyme disease vaccine trial after a third-party clinical trial site operator was found to be violating quality standards.

Around 3,500 patients will be pulled from the Phase III study due to violations of Good Clinical Practice (GCP) rules, which refer to ethical and scientific standards for clinical trials.

It is not clear exactly which elements of GCP had been breached, but Pfizer said it was not due to any safety concerns and was not prompted by an adverse event.

The trial was looking to see how effective and safe the Lyme disease vaccine is, as well as how able it is to produce an immune response in humans.

It is not the first time Pfizer clinical trials have come under scrutiny. A BMJ investigation found that just one in 20 trial sites for its widely adopted Covid vaccine had proper FDA oversight.
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Pfizer removes HALF of patients from its Lyme disease vaccine trial (msn.com)

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Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15

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Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15

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