As a follow-up to the previous petition update regarding "Direct Detection Tests for Lyme Disease"

Who's got Lyme and who doesn't ????

--------- Original Message ----------
From: CARL TUTTLE <runagain@comcast.net>
To: tickbornedisease@hhs.gov
Cc: (98 Undisclosed recipients)
Date: May 7, 2020 at 8:27 AM
Subject: VALNEVA AND PFIZER ANNOUNCE COLLABORATION TO CO-DEVELOP AND COMMERCIALIZE LYME DISEASE VACCINE, VLA15

To the Tick-Borne Disease Working Group,

Please see the letter below sent to Valneva and Pfizer with copy to the principal investigator of VLA15.

Carl Tuttle

---------- Original Message ----------
From: CARL TUTTLE <runagain@comcast.net>
To: communications@valneva.com, Steven.Danehy@pfizer.com
Cc: par.comstedt@valneva.com, urban.lundberg@valneva.com, tickbornedisease@hhs.gov, sasheller@sheller.com
Date: May 7, 2020 at 8:19 AM
Subject: VALNEVA AND PFIZER ANNOUNCE COLLABORATION TO CO-DEVELOP AND COMMERCIALIZE LYME DISEASE VACCINE, VLA15

VALNEVA AND PFIZER ANNOUNCE COLLABORATION TO CO-DEVELOP AND COMMERCIALIZE LYME DISEASE VACCINE, VLA15 

April 30, 2020 

Phase 2 vaccine candidate, VLA15, is being evaluated for adult and pediatric indications in North America and Europe. 

https://investors.pfizer.com/investor-news/press-release-details/2020/Valneva-and-Pfizer-Announce-Collaboration-to-Co-Develop-and-Commercialize-Lyme-Disease-Vaccine-VLA15/default.aspx 

To: VALNEVA AND PFIZER, 

Have your clinical studies identified adverse reactions when VLA15 is administered to an individual with active Lyme disease? All Tuttle family members advanced to late stage Lyme disease before we knew what had gone wrong with our health and none of us met the CDC’s strict criteria for positive test results. The only FDA approved two-tier serology test is useless for 4-6 weeks after a tick bite because it takes that long for humans to develop antibodies against the spirochete responsible for Lyme disease. 

So how do you plan to rule out active infection (before injection) if we don’t have an accurate and early direct detection test for Lyme disease? Our family’s experience is not unique as most Lyme patients who have become disabled by the infection went months, years or decades before diagnosis.
 
Until this scenario is recognized and fully addressed don’t expect overwhelming reception for a vaccine previously withdrawn with a record of a class action settlement for adverse reactions. 

Respectfully Submitted, 

Carl Tuttle 
Lyme Endemic Hudson, NH 

Cc: 
Tick-Borne Disease Working Group 
Sheller, P.C law firm Class Actions and Mass Torts