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Why did they stop giving Lyme Vaccinations?
I am wondering why? Does anyone know? Just curious....
Pamela Weintraub did some nice coverage on the vaccine in her book "Cure Unknown." She said that insiders knew it was not going to meet expectations even as they were pushing to get it out. There was some activity by researchers before the release that implied they were already exploring an alternative method of vaccination. I don't remember the specifics, but she explains it well.
She also explains how the CDC interpretation for the Western Blot was developed by Allen Steere (who was the primary guy on the LymeRix vaccine) to exclude the two Lyme specific antibodies that would be generated by the vaccine. They didn't want false positives in vaccinated patients.
He defended it later saying that don't need to redo the band interpretation for unvaccinated patients as they'll have enough other antibodies to show "positive" on his criteria. (And that is why I showed Lyme specific band 31 on my IGeneX IgM Western Blot, but negative on the CDC bands, except for 41, which most everybody has). Allen Steere says my example won't happen as band 31 is only triggered on entry to the skin. But what about all us neuro patients sick more than a year who frequently show band 31? Yet another example of someone's speculation getting confused with fact.
I also found a letter written by a participant in the trials. I don't remember whether he wrote it to health officials or the press, but he described how he had an adverse reaction (he developed symptoms of Lyme Disease) and reported it loud and clear. He heard through the grapevine that others had, too. And then, he was shocked when they releseased it and announced 'no adverse affect.' He claims the approval was fraudulent and that his and others' adverse reactions were covered up. This could explain why the lawsuit has been allowed to proceed.
Some docs have speculated that the vaccine "woke up" a dormant or low grade case of Lyme. Since Lyme can lie low in the body for a while, some people don't know they're carrying it. Since tests don't always reveal these cases, it would be impossible to know if someone could take the vaccine without triggering an unintended case of Lyme. This is a good argument for calling it "unsafe."
I read an article by an IDSA doc in New York where he stated almost contemptuously that the vaccine was good, but that a bunch of noisy activists scared people off it and so sales plummeted. Unfortunately, many people believe this story.
In reality, according to Weintraub, the CDC had already warned GSK that if they didn't pull it voluntarily, the CDC would order it withdrawn as unsafe. Either way it was a failure, but by pulling it themselves, GSK could continue with the claim that it was because of poor sales. The lawsuit may show otherwise. I hope the plaintiffs don't agree to a confidential settlement. The evidence needs to be public.
She also explains how the CDC interpretation for the Western Blot was developed by Allen Steere (who was the primary guy on the LymeRix vaccine) to exclude the two Lyme specific antibodies that would be generated by the vaccine. They didn't want false positives in vaccinated patients.
He defended it later saying that don't need to redo the band interpretation for unvaccinated patients as they'll have enough other antibodies to show "positive" on his criteria. (And that is why I showed Lyme specific band 31 on my IGeneX IgM Western Blot, but negative on the CDC bands, except for 41, which most everybody has). Allen Steere says my example won't happen as band 31 is only triggered on entry to the skin. But what about all us neuro patients sick more than a year who frequently show band 31? Yet another example of someone's speculation getting confused with fact.
I also found a letter written by a participant in the trials. I don't remember whether he wrote it to health officials or the press, but he described how he had an adverse reaction (he developed symptoms of Lyme Disease) and reported it loud and clear. He heard through the grapevine that others had, too. And then, he was shocked when they releseased it and announced 'no adverse affect.' He claims the approval was fraudulent and that his and others' adverse reactions were covered up. This could explain why the lawsuit has been allowed to proceed.
Some docs have speculated that the vaccine "woke up" a dormant or low grade case of Lyme. Since Lyme can lie low in the body for a while, some people don't know they're carrying it. Since tests don't always reveal these cases, it would be impossible to know if someone could take the vaccine without triggering an unintended case of Lyme. This is a good argument for calling it "unsafe."
I read an article by an IDSA doc in New York where he stated almost contemptuously that the vaccine was good, but that a bunch of noisy activists scared people off it and so sales plummeted. Unfortunately, many people believe this story.
In reality, according to Weintraub, the CDC had already warned GSK that if they didn't pull it voluntarily, the CDC would order it withdrawn as unsafe. Either way it was a failure, but by pulling it themselves, GSK could continue with the claim that it was because of poor sales. The lawsuit may show otherwise. I hope the plaintiffs don't agree to a confidential settlement. The evidence needs to be public.
[part two]
These include the following:
(1) the mechanism of action;
(2) the target population;
(3) the existence of other tick-borne disease agents transmitted by the same vector;
(4) limited geographic distribution;
(5) the relatively low illness severity in the majority of Lyme disease cases, in comparison with the illness severity of other vaccine-preventable diseases; and
(6) support from the health care delivery system in the use of a vaccine.
"An ideal vaccine must be able to induce a high and sustained duration of protection, preferably for a number of years and with the fewest number of booster doses possible (ideally, with no booster doses). LYMErix lacks some of these ideal characteristics owing to its unusual mode of action as a 'transmission blocking' vaccine.
Because the vaccine-induced protective response occurs in the nymph or adult tick vector when it feeds and before the causative spirochete enters the human host, the vaccine must produce high levels of circulating antibody to ensure protection against infection at the time of a tick bite.
“Breakthrough” infections cannot be cleared by host antibodies or trigger an anamnestic response, because B. burgdorferi no longer synthesize OspA at the time of entry into skin. Therefore, although OspA-based vaccines have been shown to be effective, it is unlikely that adequately protective titers can be achieved and maintained without multiple booster vaccinations. If fewer booster doses are important for the success of an ideal Lyme disease vaccine, antigens other than OspA may need to be identified.
"A second concern about a new candidate Lyme disease vaccine relates to the necessity for the vaccine to be approved for use in the highest-risk groups. As mentioned above, one of the limitations of LYMErix was that, at the time of licensing, it had not yet been approved for use in children <15 years of age. Consequently, the vaccine was not available for one of the groups at highest risk for contracting Lyme disease, children 5–14 years of age. It is imperative that a second-generation Lyme disease vaccine is demonstrated to be safe and effective in this target population.
"A third concern for a new Lyme disease vaccine has to do with the potential false sense of security that could result in vaccinated individuals who neglect to consider that the ticks that transmit Lyme disease transmit a number of other pathogens, as well. The black-legged tick Ixodes scapularis is the primary vector of both Babesia microti and Anaplasma phagocytphilum, which are the causal agents of babesiosis and human granulocytic anaplasmosis, respectively. There is a concern that persons who receive a Lyme disease vaccine may not be as vigilant in protecting themselves against tick bites and, therefore, may be at increased risk of acquiring these other pathogens. Consequently, if a second-generation Lyme disease vaccine becomes available, vaccine administration should occur in a context in which vaccine recipients realize that they must continue to employ personal protective measures against ticks to avoid these other disease agents.
"Two additional considerations in the development of a future Lyme disease vaccine are important to recognize. First, sales for a vaccine will most likely be geographically limited to the Northeastern and Midwestern regions of the United States, because Lyme disease risk is largely regional. Second, Lyme disease, when accurately diagnosed, is generally treatable with antimicrobials.
"Finally, to achieve commercial success in the Unites States, a Lyme disease vaccine must be broadly supported by key partners in the health care system. These partners include the vaccine industry, patients, providers, patient organizations, payers, and federal and state governments, including advisory bodies to the government, such as the ACIP. Support from these key components of the health care system facilitates development and introduction of new vaccines to address public health needs. Communication, education, and transparency throughout the development and licensure process results in a deeper understanding of the vaccine, especially in the case of a vaccine for Lyme disease, and how its use may be beneficial to the individual and the broader society. This understanding helps to inform attitudes about the vaccine not only among those individuals who are most vulnerable to Lyme disease but also among all of the other stakeholders who share a partnership role in vaccine development, licensing, distribution, and administration."
===end quote===
These include the following:
(1) the mechanism of action;
(2) the target population;
(3) the existence of other tick-borne disease agents transmitted by the same vector;
(4) limited geographic distribution;
(5) the relatively low illness severity in the majority of Lyme disease cases, in comparison with the illness severity of other vaccine-preventable diseases; and
(6) support from the health care delivery system in the use of a vaccine.
"An ideal vaccine must be able to induce a high and sustained duration of protection, preferably for a number of years and with the fewest number of booster doses possible (ideally, with no booster doses). LYMErix lacks some of these ideal characteristics owing to its unusual mode of action as a 'transmission blocking' vaccine.
Because the vaccine-induced protective response occurs in the nymph or adult tick vector when it feeds and before the causative spirochete enters the human host, the vaccine must produce high levels of circulating antibody to ensure protection against infection at the time of a tick bite.
“Breakthrough” infections cannot be cleared by host antibodies or trigger an anamnestic response, because B. burgdorferi no longer synthesize OspA at the time of entry into skin. Therefore, although OspA-based vaccines have been shown to be effective, it is unlikely that adequately protective titers can be achieved and maintained without multiple booster vaccinations. If fewer booster doses are important for the success of an ideal Lyme disease vaccine, antigens other than OspA may need to be identified.
"A second concern about a new candidate Lyme disease vaccine relates to the necessity for the vaccine to be approved for use in the highest-risk groups. As mentioned above, one of the limitations of LYMErix was that, at the time of licensing, it had not yet been approved for use in children <15 years of age. Consequently, the vaccine was not available for one of the groups at highest risk for contracting Lyme disease, children 5–14 years of age. It is imperative that a second-generation Lyme disease vaccine is demonstrated to be safe and effective in this target population.
"A third concern for a new Lyme disease vaccine has to do with the potential false sense of security that could result in vaccinated individuals who neglect to consider that the ticks that transmit Lyme disease transmit a number of other pathogens, as well. The black-legged tick Ixodes scapularis is the primary vector of both Babesia microti and Anaplasma phagocytphilum, which are the causal agents of babesiosis and human granulocytic anaplasmosis, respectively. There is a concern that persons who receive a Lyme disease vaccine may not be as vigilant in protecting themselves against tick bites and, therefore, may be at increased risk of acquiring these other pathogens. Consequently, if a second-generation Lyme disease vaccine becomes available, vaccine administration should occur in a context in which vaccine recipients realize that they must continue to employ personal protective measures against ticks to avoid these other disease agents.
"Two additional considerations in the development of a future Lyme disease vaccine are important to recognize. First, sales for a vaccine will most likely be geographically limited to the Northeastern and Midwestern regions of the United States, because Lyme disease risk is largely regional. Second, Lyme disease, when accurately diagnosed, is generally treatable with antimicrobials.
"Finally, to achieve commercial success in the Unites States, a Lyme disease vaccine must be broadly supported by key partners in the health care system. These partners include the vaccine industry, patients, providers, patient organizations, payers, and federal and state governments, including advisory bodies to the government, such as the ACIP. Support from these key components of the health care system facilitates development and introduction of new vaccines to address public health needs. Communication, education, and transparency throughout the development and licensure process results in a deeper understanding of the vaccine, especially in the case of a vaccine for Lyme disease, and how its use may be beneficial to the individual and the broader society. This understanding helps to inform attitudes about the vaccine not only among those individuals who are most vulnerable to Lyme disease but also among all of the other stakeholders who share a partnership role in vaccine development, licensing, distribution, and administration."
===end quote===
[this reply is too long for one message, so it's split into two]
Below are some snippets from a 2011 article in Clinical Infectious Disease (Clin Infect Dis. (2011) 52 (suppl 3): s247-s252) titled "The Need for a New Lyme Disease Vaccine" [footnotes omitted].
I found it at this website, if you want to read the whole thing:
http : // cid . oxfordjournals . org / content / 52 / suppl_3/s247 . full
My take on the article, which seems to take the attitude that the vaccine was fine, it just had a few issues that resulted in a lawsuit against the vaccine manufacturer. (IMO, if they were few and relatively minor issues, the manufacturer could have defended the vaccine, but apparently realized it was a loser of a case ... and why would that be? Umm, that there were problems with the vaccine, and Lyme is more complicated than they realized. This is an aspect of Lyme that IDSA is still not grappling with.)
You will also note that they drag out the old argument that Lyme only occurs in small, isolated areas of the US, so no big deal.
Thus there were several problems with the vaccine, with the lack of true understanding of Lyme [and its differences from other infectious diseases] by the medical profession, by the unique way the vaccine worked that requires more booster shots than other vaccines, and several other aspects, some noted in the quotes below.
Bottom line: the vaccine was poorly designed to roll out to a large population, and the medical profession still doesn't understand how serious and widespread the infection is. *Still.*
==begin quote===
"Despite the favorable results obtained in the phase III trial and the lack of evidence of excess adverse events as reported through VAERS [Vaccine Adverse Event Reporting System], accounts of patients who had experienced serious vaccine-related complications began to surface in the media and on the internet. These accounts were followed by allegations that many patients with adverse events were not properly reported to VAERS and that physicians in general were poorly educated on the proper use of the vaccine. These adverse events were publicized broadly, and in December 1999, a class action lawsuit was filed by Sheller, Ludwig, and Bailey.
"In February 2002, GlaxoSmithKline (formerly SmithKlineBeecham) voluntarily discontinued distribution of LYMErix, citing poor sales, and withdrew their license several years later. A number of perceived factors, however, can be speculated to have contributed to the decision by GlaxoSmithKline. These include the negative publicity linked to unconfirmed adverse events, a looming class action lawsuit, perceived safety concerns resulting in a reduction in public confidence, the failure to recognize and allow for the facts that the Lyme ticks also often carry other diseases that need to be prepared for and what was interpreted by some as a weak public health recommendation for use by the CDC and ACIP [an arm of the Centers for Disease Control that focuses on vaccines]. Each of these factors is very important, not only in relationship to the failure of LYMErix, but also to the success of any future human Lyme disease vaccines. ...
...
"EXPECTATIONS FOR A SUCCESSFUL NEW LYME DISEASE VACCINE [meaning to replace the one that already failed]
"Future prospects for a new Lyme disease vaccine depend on understanding and addressing issues at the intersection of science, policy, and public perception. Three key factors compel the call for a Lyme disease vaccine strategy in the United States and other parts of the globe. These include the steady increase in reported cases, the threat of geographic expansion of areas of endemicity, and the insufficiency of current alternative prevention methods. The experience with LYMErix—both for the pharmaceutical industry, which lost millions of dollars, and for some of the public at risk, who felt that the vaccine was not safe—has led to a clearer understanding of factors that can influence the success of a second-generation vaccine. In addition to the general considerations for an ideal vaccine—safety, efficacy, and cost-effectiveness—there are other factors to consider that are unique to the success of a Lyme disease vaccine.
[continued below]
Below are some snippets from a 2011 article in Clinical Infectious Disease (Clin Infect Dis. (2011) 52 (suppl 3): s247-s252) titled "The Need for a New Lyme Disease Vaccine" [footnotes omitted].
I found it at this website, if you want to read the whole thing:
http : // cid . oxfordjournals . org / content / 52 / suppl_3/s247 . full
My take on the article, which seems to take the attitude that the vaccine was fine, it just had a few issues that resulted in a lawsuit against the vaccine manufacturer. (IMO, if they were few and relatively minor issues, the manufacturer could have defended the vaccine, but apparently realized it was a loser of a case ... and why would that be? Umm, that there were problems with the vaccine, and Lyme is more complicated than they realized. This is an aspect of Lyme that IDSA is still not grappling with.)
You will also note that they drag out the old argument that Lyme only occurs in small, isolated areas of the US, so no big deal.
Thus there were several problems with the vaccine, with the lack of true understanding of Lyme [and its differences from other infectious diseases] by the medical profession, by the unique way the vaccine worked that requires more booster shots than other vaccines, and several other aspects, some noted in the quotes below.
Bottom line: the vaccine was poorly designed to roll out to a large population, and the medical profession still doesn't understand how serious and widespread the infection is. *Still.*
==begin quote===
"Despite the favorable results obtained in the phase III trial and the lack of evidence of excess adverse events as reported through VAERS [Vaccine Adverse Event Reporting System], accounts of patients who had experienced serious vaccine-related complications began to surface in the media and on the internet. These accounts were followed by allegations that many patients with adverse events were not properly reported to VAERS and that physicians in general were poorly educated on the proper use of the vaccine. These adverse events were publicized broadly, and in December 1999, a class action lawsuit was filed by Sheller, Ludwig, and Bailey.
"In February 2002, GlaxoSmithKline (formerly SmithKlineBeecham) voluntarily discontinued distribution of LYMErix, citing poor sales, and withdrew their license several years later. A number of perceived factors, however, can be speculated to have contributed to the decision by GlaxoSmithKline. These include the negative publicity linked to unconfirmed adverse events, a looming class action lawsuit, perceived safety concerns resulting in a reduction in public confidence, the failure to recognize and allow for the facts that the Lyme ticks also often carry other diseases that need to be prepared for and what was interpreted by some as a weak public health recommendation for use by the CDC and ACIP [an arm of the Centers for Disease Control that focuses on vaccines]. Each of these factors is very important, not only in relationship to the failure of LYMErix, but also to the success of any future human Lyme disease vaccines. ...
...
"EXPECTATIONS FOR A SUCCESSFUL NEW LYME DISEASE VACCINE [meaning to replace the one that already failed]
"Future prospects for a new Lyme disease vaccine depend on understanding and addressing issues at the intersection of science, policy, and public perception. Three key factors compel the call for a Lyme disease vaccine strategy in the United States and other parts of the globe. These include the steady increase in reported cases, the threat of geographic expansion of areas of endemicity, and the insufficiency of current alternative prevention methods. The experience with LYMErix—both for the pharmaceutical industry, which lost millions of dollars, and for some of the public at risk, who felt that the vaccine was not safe—has led to a clearer understanding of factors that can influence the success of a second-generation vaccine. In addition to the general considerations for an ideal vaccine—safety, efficacy, and cost-effectiveness—there are other factors to consider that are unique to the success of a Lyme disease vaccine.
[continued below]
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