Huh. Quite a coincidence. One week after I emailed a phase III trial administrator of the Pfizer/Valneva concoction, we have news and news that half of one study contractor's participants have been dismissed.
Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announce that Pfizer, as the study sponsor, has decided to discontinue a significant percentage of participants in the U.S. who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15. These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator. The discontinuation of these participants was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event.
Here is the article I read a week ago that prompted me to express my concern about the trial:
Notice at the end of the article there is an email for that site's coordinator, Grace Royster:
"If we're able to get a vaccine available to the public, that would be sort of a game changer in being able to put a handle on that disease and the prevalence that it has in the country and especially in Virginia," said study coordinator Grace Royster.
It's a two-year study made up of four shots and six visits altogether. Pediatric Associates of Charlottesville is looking for at least 35 more children between the ages of five and 17 to participate.
Anyone interested in enrolling their child in the study should email grace@proc211 dotcom.
How could I not contact her, considering I've tried everything else, including telling the FDA myself that you can't inject recombinant OspA into people because it does the same thing as OspA injected by tick?
So, this is the email I sent exactly one week ago:
Reminds me of that time a certain Designated Federal Officer for the HHS Tick-Borne Disease Working Group suddenly and inexplicably left his post two days after our expose went live.
Yep, poking the bear...in just the right spot.