Why was the Lyme Vaccine LYMErix, Pulled from the Market?

lyme vaccine

The Lyme Vaccine Controversy

Between December 28, 1998 and July 31, 2000, there were 905 reports made to the
Vaccine Adverse Event Reporting System (VAERS) about adverse reactions after the administration of the Lyme disease vaccine, LYMErix. There were 66 of these reports that were deemed life-threatening. Eventually this led to a class action suit filed against SmithKline.

Some people involved in the making of LYMErix were concerned because they said that
some people with certain genetic dispositions were predisposed to develop issues such as arthritis after the Lyme vaccine along with neuro issues.

The law suit against SmithKline stated that pne of the issues was that SmithKline used high concentrations of a surface protein called OspA as the foundation for its vaccine. The levels of OspA that enter the bloodstream at any phase of the three-dose LYMErix vaccine, place patients classified by genetic type HLA-DR4+ at risk of developing a condition referred to as “treatment-resistant” Lyme Arthritis.

Despite knowing this well known relationship’ between OspA and treatment-resistant Lyme Arthritis, SmithKline didn’t add this important information in the promotional literature for the Lyme vaccine. They insisted LYMErix was safe and well tolerated.

A class-action lawsuit asked that SmithKline Beecham add this information to the vaccine’s label. (Still looking for their response to this request.)

Because of the concerns expressed about the potential safety of the vaccine, in May 1998, an FDA panel met to review the proposed Lyme disease vaccine (LYMErix).

Here were their conclusions:

  • The panel concluded that the vaccine did not protect against Lyme disease due to other B. burgdorferi subspecies outside of the United States.
  • The panel concluded that individuals who were vaccinated would not be fully protected until the year after the start of the series.
  • That the vaccine was not cost effective.
  • The panel noted there were no long-term safety data.
  • The panel concluded that persons who received the vaccine would be positive by enzyme-linked immunosorbent assay for antibody to Lyme disease (which could be confusing to clinicians). (In layman terms, once you get the vaccine you will always test positive for Lyme Disease).
  • There was no data showing if vaccine recipients would need booster doses,
  • The vaccine could not be used in young children who were the ones at highest risk.
  • The panel raised the question of a possible relationship to autoimmune arthritis and those who received the vaccine.

Even with these questions and the lack of data they needed to quell safety concerns, , the FDA panel gave unanimous support for licensure of this vaccine.

Eventually In 2002, in response to low vaccine uptake, public concern about adverse effects, and class action lawsuits caused SmithKline Beecham to withdraw the vaccine from the market. It may have been too late for many people who to this day suffer from the affects of LYMErix.

Id you are wondering where the proof of the vaccine injured people are, well read this article by Dr Mercola, “Government Wipes Recent Vaccine Injury Data from Website.”

With the announcement that they are close to releasing a new Lyme vaccine, many people are concerned it will have the same devastating affects. For more on the new Lyme vaccine called,   named VLA15-101, please read, FDA Gives Green Light to Test Lyme Disease Vaccine on Humans.”

If you were one of the people who received the LYMErix vaccine and became ill due to it, please leave your story below in the comment section.

Please Read the Following Research Papers and Articles for More Information on both sides of this Vaccine Controversy

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