On 2013 Dec 19, Raphael Stricker commented:

Our Letter to the Editor of Lancet Infectious Diseases (2014;14:12) expressed concern about the safety of the new Lyme OspA vaccine from Baxter Bioscience. This concern is based on safety issues related to the previous Lyme OspA vaccine, Lymerix®, which was taken off the market after these safety issues surfaced, as outlined in our letter.

In their response to our letter, the employees of Baxter Bioscience who studied the new vaccine made the following comment: “There are no data in Stricker and Johnson’s cited publications that support the statement that ‘joint-reactive and nerve-reactive antibodies’ are induced in human beings vaccinated with OspA antigen.” This comment is misleading because OspA vaccine-related antibodies against nerve and joint tissue have been detected in animals and humans described in the references below. Furthermore, the fact that antibodies with unknown reactivity were induced by Lymerix® vaccination presents an unresolved safety issue for the new OspA vaccine, and this issue was not addressed by the Baxter Bioscience employees who studied the vaccine.

Once again, the willingness of Baxter Bioscience to ignore legitimate safety concerns bodes ill for the new Lyme vaccine.

Raphael B. Stricker, MD, Lorraine Johnson, JD, MBA

References

1. Stricker RB. Lymerix® risks revisited. Microbe 2008;3:1-2.

2. Smith P, Gaito A, Marks DH. Transcript of FDA Lymerix Meeting, Bethesda, MD, January 22, 2002. Available at: http://www.lymediseaseassociation.org/index.php?option=com_content&view=article&id=532:lymerix-meeting&catid=129:hhsfood-a-drug-administration-fda&Itemid=531

3. Croke CL, Munson EL, Lovrich SD, et al. Occurrence of severe destructive Lyme arthritis in hamsters vaccinated with outer surface protein A and challenged with Borrelia burgdorferi. Infect Immun. 2000;68:658–63.

4. Rose CD, Fawcett PT, Gibney KM. Arthritis following recombinant outer surface protein A vaccination for Lyme disease. J Rheumatol. 2001;28:2555–7.

5. Latov N, Wu AT, Chin RL, Sander HW, Alaedini A, Brannagan TH. Neuropathy and cognitive impairment following vaccination with the OspA protein of Borrelia burgdorferi. Periph Nerv Syst. 2004;9:165–7.

6. Alaedini A, Latov N. Antibodies against OspA epitopes of Borrelia burgdorferi cross-react with neural tissue. J Neuroimmunol. 2005;159:192–5.

7. Souayah N, Ajroud-Driss S, Sander HW, Brannagan TH, Hays AP, Chin RL. Small fiber neuropathy following vaccination for rabies, varicella or Lyme disease. Vaccine 2009;27:7322-5.

8. Marks DH. Neurological complications of vaccination with outer surface protein A (OspA). Int J Risk Saf Med. 2011;23:89-96.

9. Molloy PJ, Berardi VP, Persing DH, Sigal LH. Detection of multiple reactive protein species by immunoblotting after recombinant outer surface protein A Lyme disease vaccination. Clin Infect Dis. 2000;31:42-7.

10. Fawcett PT, Rose CD, Budd SM, Gibney KM. Effect of immunization with recombinant OspA on serologic tests for Lyme borreliosis. Clin Diagn Lab Immunol. 2001;8:79-84.

11. Hanson MS, Edelman R. Progress and controversy surrounding vaccines against Lyme disease. Expert Rev Vaccines 2003;2:683–703.

12. Nigrovic LE, Thompson KM. The Lyme vaccine: a cautionary tale. Epidemiol Infect. 2007;135:1–8.

13. Nardelli DT, Munson EL, Callister SM, Schell RF. Human Lyme disease vaccines: past and future concerns. Future Microbiol. 2009;4:457-69.

14. Smith P. Remarks to Vaccines and Related Biological Products Advisory Committee, Bethesda, MD, January 31, 2001. Available at: http://www.lymediseaseassociation.org/index.php?option=com_content&view=article&id=262:vaccine-remarks&catid=80:controversy&Itemid=76

Disclosure: RBS and LJ are members of the International Lyme and Associated Diseases Society (ILADS) and directors of LymeDisease.org. They have no financial or other conflicts to declare.

On 2013 Dec 19, Raphael Stricker commented:

Our Letter to the Editor of Lancet Infectious Diseases (2014;14:12) expressed concern about the safety of the new Lyme OspA vaccine from Baxter Bioscience. This concern is based on safety issues related to the previous Lyme OspA vaccine, Lymerix®, which was taken off the market after these safety issues surfaced, as outlined in our letter.

In their response to our letter, the employees of Baxter Bioscience who studied the new vaccine made the following comment: “There are no data in Stricker and Johnson’s cited publications that support the statement that ‘joint-reactive and nerve-reactive antibodies’ are induced in human beings vaccinated with OspA antigen.” This comment is misleading because OspA vaccine-related antibodies against nerve and joint tissue have been detected in animals and humans described in the references below. Furthermore, the fact that antibodies with unknown reactivity were induced by Lymerix® vaccination presents an unresolved safety issue for the new OspA vaccine, and this issue was not addressed by the Baxter Bioscience employees who studied the vaccine.

Once again, the willingness of Baxter Bioscience to ignore legitimate safety concerns bodes ill for the new Lyme vaccine.

Raphael B. Stricker, MD, Lorraine Johnson, JD, MBA

References

1. Stricker RB. Lymerix® risks revisited. Microbe 2008;3:1-2.

2. Smith P, Gaito A, Marks DH. Transcript of FDA Lymerix Meeting, Bethesda, MD, January 22, 2002. Available at: http://www.lymediseaseassociation.org/index.php?option=com_content&view=article&id=532:lymerix-meeting&catid=129:hhsfood-a-drug-administration-fda&Itemid=531

3. Croke CL, Munson EL, Lovrich SD, et al. Occurrence of severe destructive Lyme arthritis in hamsters vaccinated with outer surface protein A and challenged with Borrelia burgdorferi. Infect Immun. 2000;68:658–63.

4. Rose CD, Fawcett PT, Gibney KM. Arthritis following recombinant outer surface protein A vaccination for Lyme disease. J Rheumatol. 2001;28:2555–7.

5. Latov N, Wu AT, Chin RL, Sander HW, Alaedini A, Brannagan TH. Neuropathy and cognitive impairment following vaccination with the OspA protein of Borrelia burgdorferi. Periph Nerv Syst. 2004;9:165–7.

6. Alaedini A, Latov N. Antibodies against OspA epitopes of Borrelia burgdorferi cross-react with neural tissue. J Neuroimmunol. 2005;159:192–5.

7. Souayah N, Ajroud-Driss S, Sander HW, Brannagan TH, Hays AP, Chin RL. Small fiber neuropathy following vaccination for rabies, varicella or Lyme disease. Vaccine 2009;27:7322-5.

8. Marks DH. Neurological complications of vaccination with outer surface protein A (OspA). Int J Risk Saf Med. 2011;23:89-96.

9. Molloy PJ, Berardi VP, Persing DH, Sigal LH. Detection of multiple reactive protein species by immunoblotting after recombinant outer surface protein A Lyme disease vaccination. Clin Infect Dis. 2000;31:42-7.

10. Fawcett PT, Rose CD, Budd SM, Gibney KM. Effect of immunization with recombinant OspA on serologic tests for Lyme borreliosis. Clin Diagn Lab Immunol. 2001;8:79-84.

11. Hanson MS, Edelman R. Progress and controversy surrounding vaccines against Lyme disease. Expert Rev Vaccines 2003;2:683–703.

12. Nigrovic LE, Thompson KM. The Lyme vaccine: a cautionary tale. Epidemiol Infect. 2007;135:1–8.

13. Nardelli DT, Munson EL, Callister SM, Schell RF. Human Lyme disease vaccines: past and future concerns. Future Microbiol. 2009;4:457-69.

14. Smith P. Remarks to Vaccines and Related Biological Products Advisory Committee, Bethesda, MD, January 31, 2001. Available at: http://www.lymediseaseassociation.org/index.php?option=com_content&view=article&id=262:vaccine-remarks&catid=80:controversy&Itemid=76

Disclosure: RBS and LJ are members of the International Lyme and Associated Diseases Society (ILADS) and directors of LymeDisease.org. They have no financial or other conflicts to declare.