LDA President’s Blog– In-depth Synopsis of Advocate Vaccine Meeting Hosted by CDC

There are many versions of what happened out there on the net about the meeting held March 7 and 8 at the CDC Atlanta. Here is a detailed version from my perspective of that meeting including the Centers for Disease Control & Prevention’s (CDC) actual role in the meeting.

HISTORY: LDA has always been concerned about the new vaccine in FDA trials, but when Pfizer/Valneva might have had the Lyme vaccine ready to roll out in 2025, LDA questioned some entities about getting answers to the questions from the manufacturer about what happened with LYMERix®. No answers were received.

I contacted the CDC to find out what role it plays in the vaccine process. I found out that a Vaccine Advisory Committee makes policies on who gets the vaccine and dosage, etc. It sends those findings to CDC who does not have to agree with those making the CDC recommendations.

MEETING ORIGIN: I asked CDC to try to get some answers to some questions the LDA  has had from the LYMERix® vaccine which was withdrawn from the market by the manufacturer due to poor sales in early 2002.  An example of a question,  the LYMERix® base was one OSPA. The Pfizer base is 6 OSPAs, most from Europe. A number of LYMERix® concerns came from the OSPA base. Valneva/Prizer indicated they took the offending part of the OSPA out, but in other places, it was indicated that there was no problem with the LYMERix® vaccine. So, which is it? The base of the vaccine was a problem  or there was no problem, but P/V removed a section of the base anyway. Why and how was it decided to remove it? What studies have been done by them on the issue? I also asked why the Lyme Community was not brought into the new vaccine development and trial  process.

The CDC came back with an idea to host a meeting using Lyme advocates to put together questions to ask Pfizer about the vaccine. It was similar to expert meetings CDC hosts with Technical Consultants, and advocates were offered to attend this meeting and give their input into the Technical Consultation with Expert Advocates meeting. In other meetings CDC has hosted with Technical Consultants, Consultants are offered a stipend to provide input into issues. CDC indicated it was only fair the Advocates were offered a stipend by CDC. (I did not accept the stipend). Arrangements were coordinated by CDC for travel, hotel reservations and food in Atlanta and Advocates were reimbursed up to certain allowances per diem. I could not travel at that time, so CDC allowed me to come in online, since I was the advocate with “lived experience” on the earlier vaccine.

PRIOR TO DAY 1 I found out information online that some of the Atlanta Lyme Advocate groups quietly, unknown to others, at least to me and apparently to CDC, had put out some kind of vaccine survey to people in emails, maybe elsewhere. I called the CDC when I saw that had occurred, and they apparently had just found out. My immediate concern, which I expressed to the Atlanta Advocates after hearing this, was that this may keep Pfizer from providing us with information. This type of meeting was delicate, that was also stressed before the Atlanta meeting. Info would be put out after the Atlanta meeting on the meeting and questions.

DURING DAY 1 we heard during our Day 1 meeting that lots of individuals on line were incredibly angry when they read this Lyme Advocate survey on the Lyme Vaccine and incomplete meeting info. I did not read any of that online. I just heard Advocates talk about it after the fact at our meeting. Those who wrote about it online  were reportedly mad at Lyme advocates who were attending this meeting, and they felt, were colluding with CDC on vaccines. That was not the case, but this is what can happen when premature, incomplete information is given out and implications about how this action might affect this meeting were not considered nor presented to the meeting sponsor and to other attendees for input prior to this meeting.

PFIZER PULLS ITS VIDEO TO ADVOCATES OUT OF THE ATLANTA AGENDA: Turned out that shortly after that survey was put out, coincidence or not, Pfizer sent CDC a message that they would not present the Recorded message to us Lyme Advocates in Atlanta scheduled for 11:15 on the 7th, no real explanation given. Instead, they sent a list, which printed 40+ pages on my computer, of all their old PR, most of which LDA had on its website for years, probably other groups did, too. I cannot state unequivocally what reasons Pfizer had for pulling the survey, but the above is what occurred. We got no update from Pfizer at the meeting.

Sometime over the 2-day meeting, I asked why, during the vaccine development/trial process, Pfizer/Valneva never brought in Lyme community stakeholders for input and the answer was, they never thought about it.

My Ending Comment At the tail end of the meeting, I thanked all there, Advocates, CDC reps, the Pfizer question person, but could not leave without saying what had really not been addressed. Someone had to say it on behalf of patients everywhere. I do not have the below in quotes as this statement came from the heart not from preplanning, but basically, this is a portion of what I said:

As usual, Lyme patients and advocates everywhere have again been dismissed. Almost 50 years since Polly Murray, a mother, spread the word to health officials about what we now know as Lyme disease. We have no definitive test, no effective treatments accepted, even by government, no belief in chronic Lyme, little government research, doctors still afraid to treat, and Pfizer did not even have the courtesy to come and to present an updated video on a proposed vaccine* and did not even solicit input from the Lyme Community on the potential vaccine—a slap in the face. I started as a mother of 3, as a Lyme educator/advocate. Now I’m a grandmother of 4. I am still here because little has been done for Lyme and now many other TBDs, and few continue to do anything about them.  *Pfizer representative was there to take down the questions we developed for Pfizer but could not really  answer questions. 

To my knowledge, questions have not yet been submitted to Pfizer as attendees have time to provide more input into the questions developed at the meeting by email to the CDC.

MEETING OBJECTIVES: Day 1 From CDC

• Achieve group understanding of the vaccine development and safety monitoring process
• Develop a list of questions that may help to inform Lyme vaccine program development and implementation if a Lyme vaccine is approved for use in the U.S. in the coming years
• Continue to develop relationships that expands CDC’s understanding of the lived experience of Lyme disease (from patients, caregivers, and leadership from patient-driven research organizations)

MEETING AGENDA: Day 1 From CDC

• 9:00am – 9:30am – Welcome and Introductions
  • Dr. Nirav Shah, Principal Deputy Director, CDC
  • Dr. Lyle Petersen, Director, Division of Vector-Borne Diseases (DVBD), NCEZID, CDC
  • Dr. Sue Visser, Deputy Director for Policy and Extramural Program, DVBD, NCEZID, CDC
• 9:30 – 9:45 – Overview of the Day Ahead with Dr. Sue Visser
• 9:45 – 10:15 – Group Activity: Sailboat Retrospective for Vaccine-Based Prevention of Lyme Disease
• 10:30 – 11:00 – Group Discussion: LYMERix® Historical Reflection
• 11:00 – 11:15 – BREAK
• 11:15 – 11:30 am – Recorded Presentation on VLA15 – Pfizer (Cancelled by Pfizer-read above)
• 11:30 am – 12:00 pm – Presentation: Relative Roles in Vaccine Development and Monitoring
  • Dr. Paul Mead, Branch Chief, Bacterial Diseases Branch Dr. Grace Marx, Bacterial Diseases Branch
• 12:00 – 1:00 – LUNCH
• 1:00 – 2:30 – Group Activity: Question generation about VLA15 or a future Lyme disease vaccine program
• 2:30 – 3:00 – BREAK
• 3:00 – 4:00 – Group Discussion: Review questions, themes, and assignment
• 4:00 – 4:30 – Preview of Day 2; Q and A with Dr. Sue Visser
• 4:30 – ADJOURN
• 7:00 – Optional dinner at The Club Room, Emory Conference Center Hotel

MEETING OBJECTIVES: Day 2 From CDC

• Share and review the list of Day 1 questions with Christine Hanson, Pfizer
• The group may answer any clarifying questions that Christine Hanson may have for the participants
• Continue to develop relationships that expands CDC’s understanding of the lived experience of Lyme disease (from patients, caregivers, and leadership from patient- driven research organizations)

MEETING AGENDA: Day 2 From CDC

• 8:15 am Arrive and Check-in at the CDC Visitor Center
• 8:30 – 9:30 – Welcome and Introductions, facilitated by Dr. Sue Visser
• 9:30 – 10:30 – Presentation of questions
• 10:30 – 10:45 – BREAK
• 10:45 – 11:45 – Continued presentation of questions
• 11:45 am – 12:00 pm – Closing remarks and next steps
• 12:00 – 1:00 – LUNCH
• 1:00 – 1:30 – ADJOURN