By Pat Smith, President of the Lyme Disease Association

The recent Bloomberg article on the upcoming Lyme disease vaccine was not a surprise but was certainly a disappointment to the Lyme community and the Lyme Disease Association Inc. (LDA).

The reporter spent time tracking me down to conduct an interview, as she indicated to me, many in the Lyme community had suggested to her that I should be interviewed, likely due to the LDA’s involvement in the Lyme scene during the prior vaccine withdrawal.

In 1998, at the time the first Lyme OspA vaccine, LymeRix®, was receiving FDA approval, with the most provisos− according to the chairperson−the LDA was already more than a decade into educating about and providing research funds for Lyme disease.

As LDA president, I was educating in New Jersey and elsewhere. The prevailing questions and comments were always the same: talk and questions about the vaccine−health problems that many people said they or their acquaintances were experiencing and attributing to the vaccine.

Bloomberg interview

I spent a lot of time preparing for the interview, reviewing 20+ years-old material, much of which is still transparently displayed on the LDA website for everyone. My agreement to do the interview was so that patients, advocates, and physicians who were dealing with an OspA-based Lyme vaccine issue in the past, and some still today, would finally have their voices heard.

In my opinion, entities behind the efforts to suppress information on the issue have powerful vested interests, some of these same entities who have successfully fought more than three decades to prevent Lyme patients from being treated.

They have trashed advocates in what has passed for “scientific” journal articles but were really an embarrassment, savagely attacking those helping patients. And they were emboldened by other predominant print media allies complicit in this effort. Lyme advocates were blamed for the vaccine’s demise, forget the vested interests’ culpability.

Based on the history of these interviews, I did not have much hope that the Lyme community would get fair treatment but concluded that not doing the interview would permit vested interests to have their say, and the Lyme community would be shut out entirely or would be silenced with a “refused to comment” statement.

The extensive interview resulted in me being quoted a phrase and two sentences in the article. True quotes, but innocuous in the scheme of things, are: “some people…felt they were being deceived and that the process was not transparent.… We are interested in the possibility of a vaccine. The issue is the safety and efficacy.”

Article bias?

Nowhere does the article present anything from the Lyme community’s perspective on OspA. I had shared that these perspectives support our reasons behind the concerns we have had about LymeRix® and how that applies to Valneva. However, the article states that Valneva’s chief executive writes this group off, indicating that COVID vaccine concerns caused the questioning of the new Lyme vaccine in trials.

Did Bloomberg point out OspA-based Lyme vaccines have been questioned since before the LymeRix® 2002 pullout, yet the COVID vaccine was first available under emergency authorization in 2020 and FDA approved in 2021? Not a surprise to any thinking person that the experience with the COVID vaccine has certainly triggered a growing awareness that big pharma is not always transparent and pristine in their vaccine actions, nor are they slow in pointing fingers at and marginalizing anyone who asks questions about their vaccines. Some questions that have remained unanswered for decades.

Where is the communication/education?

It was quite shocking to me to see the Valneva CEO state that their approach today to overcome vaccine resistance is “education and communication.” Where is that communication?

I have not heard about any outreach by them to Lyme groups across the country since they began considering Lyme vaccine development nor any briefings scheduled for them. Haven’t they heard of Zoom? If they wanted to educate Lyme groups, wouldn’t they have contacted the LDA which was specifically targeted in peer review as helping cause the downfall of the first vaccine?

At least SmithKline Beecham (SKB) did reach out to groups, even attending an LDA Board meeting a few times. We did not like all the answers on LymeRix®, but they at least provided a face-to-face Q & A session and heard our concerns.

I told that to Bloomberg, but they either did not ask or did not want to hear what Valneva’s response might have been, since that might weaken the article’s purpose to help sell the new Lyme vaccine for Valneva-Pfizer.

The article indicated that Valneva removed “the string of genetic code tied to the allegations of side effects,” a portion of the OspA, and “replacing it with that from another type of OspA,” all in the same breath with “Even if there was a perceived risk… the way this vaccine has been made is that risk has been taken out.”

So what studies were done by whom to determine that removing something and replacing it with something else would alleviate something perceived? They have never conceded there was a risk.

Bloomberg barely mentioned that LymeRix® only used one OspA, while Valneva-Pfizer is using six different OspAs. There were no questions as to how that might impact those getting the vaccine.

Additionally, the OspA problem was only linked at that early time with arthritic problems. There were other problems such as neurologic issues, and there is peer review examining both above issues. There were several doctors and researchers who were, respectively, providing medical care for the side effects and doing research on the issues. None of them are referenced in the article, although I provided names to Bloomberg and spoke of the peer review.

LDA meets with FDA

I also shared with Bloomberg that in 2002, the LDA was able, with great difficulty, to get a private meeting with the FDA on the LymeRix® vaccine− already having traveled down to hearings on it and spoken before the FDA vaccine committee.

The FDA used several excuses to prevent the meeting when they saw that the list of experts we were providing included doctors dealing with the issues, an attorney working on the issue, and one of the original OspA researchers heading the effort with one other OspA vaccine moving forward at same time as LymeRix®− which the company decided to stop moving forward with due to problems.

We held a meeting with the reluctant FDA. You can read about it on our LDA website. Within about a month from our meeting with the FDA, LymeRix®  pulled its vaccine citing poor sales.

Lyme-treating docs are “a cottage industry”?

The Bloomburg article contains no hard questioning of those pushing the current vaccine about the issues surrounding the early OspA vaccine; no explanation of why the Lyme community is concerned about the vaccine, although information was provided; no questioning of the drop by Pfizer-Valneva of half the trial patients citing vague “violations of good clinical practices.”

Reinforcement of the article bias is evident when coupling the above with the outrageous statement below by Bloomberg about doctors treating patients with long-term symptoms after “usual” courses of treatment:  “What’s emerged to deal with this population is a cottage industry of medical practitioners who specialize in diagnosing and treating these cases─ sometimes plying intensive , expensive and still-unproven therapies to treat people who may or may not even have Lyme.”

All the patients I know gladly take the “cottage” doctors who have spent their lives dedicated to helping patients, over the ones in their ivory towers who suppress information about Lyme, prevent patients from getting treatment, while having their fingers in every (Lyme) pie

New vaccine developments

A mention in the Bloomberg article was made about Valneva partner Pfizer suddenly dropping almost half of its trial patients citing “violations of good clinical practices” at sites run by a company conducting the trial.

Understandably, this raises concerns from the public and should. What were these violations, I asked Bloomberg. Could they be related to adverse effects from the vaccine that were occurring and being documented?

With LymeRix®, questions arose about adverse events being ignored, marginalized, not accepted into Vaccine Adverse Events System (VAERS), or even not accepted by some providers. Valneva and Pfizer need to define “violations of good clinical practices,” violations that the company, which was alleged to have committed, denies. Bloomberg chose not to explore this issue.

Cutting trial participants

Two days before Bloomberg published, more questionable actions arose.  An August 22 Fierce Biotech article announced that Pfizer suddenly now projects that many fewer recruits will be sought for the phase 3 trials.

The vaccine research and development chief is quoted: “By moving just to the high endemic areas and taking out sites where we didn’t think that people would really be at risk of getting Lyme disease, it meant that we could actually considerably reduce the number of participants that we enroll.”

I immediately sent the article to Bloomberg. Too late for their publication, perhaps? Will they investigate? A proposed clinical trial with ~half of participants for a vaccine type with murky history? Doubtful they will investigate, since somewhere on a Bloomberg website, the article on the vaccine was dubbed a “Deep Dive.”

Someone had better inform them that a “deep dive” more than scratches the surface of the ocean, there is a whole lot of murky water below that the diver needs to get through to get to the truth of this vaccine issue. Lives are at stake.

Bottom line

The public, the Food & Drug Administration, medical societies whose members will be asked to provide this vaccine if it gets approved, and the Centers for Disease Control & Prevention which promulgates vaccine guidelines, should all be clamoring for answers. The need for transparency is overwhelming.

Still unanswered questions

Here are issues we wish the Bloomberg article had explored:

• Does the FDA process require it to examine the purported complications from the former OspA vaccine, LYMErix®, and if so, what was the result? If not, did the FDA examine and report on them anyway or on any of the peer reviews that discussed potential complications, such as OspA pertaining to arthritis and those pertaining to neurologic complications?
• Did the FDA require Valneva-Pfizer to investigate and report on purported complications from LYMErix® and possible relevance to its new vaccine? If not, did Valneva-Pfizer initiate their own investigation and report on it or on any of the peer review that discussed those potential complications, such as OspA pertaining to arthritis and any neurologic complications?
• Did Valneva/FDA review any of the material contained in the class action on the later withdrawn Lawsuit filed on behalf of patients? Did the lawsuit settlement contain provision(s) that any OspA vaccine put back on the market would have to go through an entire approval process or any other restrictive provision?
• Did anyone including Bloomberg try to access all final reports given to FDA on LYMErix® by SKB up to and after it was pulled from the market by SKB? What information, if any, did Valneva-Pfizer uncover on this issue and has it been reported out anywhere publicly before, during or after their vaccine effort?
• Did Bloomberg Investigate any pitfalls and deficiencies of the Vaccine Adverse Events Reporting System (VAERS} pertaining to how input is received and accepted, and did it examine adverse events reports from the withdrawn vaccine? Do adverse events occurring during vaccine trials get reported to VAERS? If so, are there any reported on the new vaccine? If not, how and when are they reported?
• Does the FDA process require the manufacturer to reach out to stakeholders when new vaccine approvals are being sought? If Valneva-Pfizer is really transparent in their vaccine dealings, why haven’t they reached out to the Lyme community to answer questions?
• At the same time as SKB had their vaccine on the market, Connaught had an OspA vaccine trial, but they pulled their trial because they had concerns. Did Bloomberg or Valneva-Pfizer investigate and provide reports on that issue?
• Did Bloomberg or Valneva-Pfizer look into Baxter which had a Lyme vaccine in European trials years before Valneva? It reported reliable results with the Lyme vaccine trial and yet subsequently sold off a portion of its vaccine business, including the Lyme portion. To whom did Baxter sell the Lyme vaccine portion? Why did they sell off the Lyme vaccine portion if it were so productive in trials?

Pat Smith is President of the Lyme Disease Association, which funds research, promotes education and jointly puts on an annual scientific conference with Columbia University. From 2017-2020, she served on the federal Tick-Borne Disease Working Group.