New unsafe vaccines will only add to vaccine hesitancy
The HEPLISAV-B [1] hepatitis B vaccine and the SHINGRIX [2] shingles vaccine were recently approved in the US.
Hansenula polymorpha yeast is used to produce HEPLISAV-B. The HEPLISAV-B vaccine thus contains yeast proteins (up to 5% of total protein). HEPLISAV-B uses a new powerful adjuvant, CpG 1018. Clinical trials showed an increase in myocardial infarction among patients who received HEPLISAV-B, compared to controls.
Uniprot [3] lists >5000 proteins for this yeast. I randomly picked one yeast protein "Cation transport ATPase" and ran a BLASTP [4] protein sequence alignment against homo sapiens, to check for molecular mimicry/autoimmunity potential. The top match was for “copper-transporting ATPase 1 isoform 1 [Homo sapiens]”, with a match score of 559. There are also subsequent matches to Menkes’ disease and Wilson's disease associated human proteins. Copper deficiency is associated with these heart diseases. [6]
In contrast, the top BLASTP match score between the H1N1 nucleoprotein (that caused Pandemrix induced narcolepsy [5]), and homo sapiens is only 32.5.
So it seems easily possible that this yeast containing vaccine with a powerful new adjuvant is creating autoantibodies that affect copper transport to the heart, due to molecular mimicry between yeast and human proteins. This can explain the huge increase in myocardial infarction occurrence following the administration of this vaccine. Yet the vaccine has been approved.
The FDA Briefing Document (Sep 13 2017) for the FDA VRBPAC meeting below details supraventricular tachycardia and tachyarrhythmia as serious adverse events (SAE) in SHINGRIX vaccinated subjects, detected during vaccine clinical studies.
The vaccine package insert (Revised: 10/2017) [2], omits any reference to supraventricular tachycardia or tachyarrhythmia. Thus doctors who administer this vaccine are being kept in the dark about these SAEs. The Vaccine Adverse Event Reporting System (VAERS) depends on doctors reporting adverse events. Underreporting is a known problem with these passive surveillance methods. Hiding information from doctors only makes the problem worse.
The SHINGRIX vaccine contains Chinese Hamster Ovary (CHO) cell proteins used to produce the vaccine. Once again, autoimmunity [7] due to molecular mimicry between human and CHO proteins could be the cause of the SAEs.
Such vaccine approvals despite obvious safety problems detected during clinical trials, prove that vaccine regulators are not serious about safety at all.
References
1. FDA. Heplisav-B package insert [Internet]. 2017. Available from: https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedPr...
2. FDA. SHINGRIX vaccine package insert [Internet]. 2017. Available from: https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedPr...
3. UniProt: the universal protein knowledgebase. Nucleic Acids Res. 2017 Jan 4;45(D1):D158–69.
4. Arumugham V. Significant protein sequence alignment between peanut allergen epitopes and vaccine antigens [Internet]. 2016. Available from: https://www.zenodo.org/record/1034555
5. Ahmed SS, Volkmuth W, Duca J, Corti L, Pallaoro M, Pezzicoli A, et al. Antibodies to influenza nucleoprotein cross-react with human hypocretin receptor 2 (ABSTRACT ONLY). Sci Transl Med. 2015;7(294):294ra105–294ra105.
6. Nath R. Copper deficiency and heart disease: Molecular basis, recent advances and current concepts. Int J Biochem Cell Biol. 1997;29(11):1245–54.
7. Arumugham V. Cancer immunology, bioinformatics and chemokine evidence link vaccines contaminated with animal proteins to autoimmune disease: a detailed look at Crohn’s disease and Vitiligo [Internet]. 2017. Available from: https://www.zenodo.org/record/1034777
Rapid Response:
New unsafe vaccines will only add to vaccine hesitancy
The HEPLISAV-B [1] hepatitis B vaccine and the SHINGRIX [2] shingles vaccine were recently approved in the US.
Hansenula polymorpha yeast is used to produce HEPLISAV-B. The HEPLISAV-B vaccine thus contains yeast proteins (up to 5% of total protein). HEPLISAV-B uses a new powerful adjuvant, CpG 1018. Clinical trials showed an increase in myocardial infarction among patients who received HEPLISAV-B, compared to controls.
Uniprot [3] lists >5000 proteins for this yeast. I randomly picked one yeast protein "Cation transport ATPase" and ran a BLASTP [4] protein sequence alignment against homo sapiens, to check for molecular mimicry/autoimmunity potential. The top match was for “copper-transporting ATPase 1 isoform 1 [Homo sapiens]”, with a match score of 559. There are also subsequent matches to Menkes’ disease and Wilson's disease associated human proteins. Copper deficiency is associated with these heart diseases. [6]
In contrast, the top BLASTP match score between the H1N1 nucleoprotein (that caused Pandemrix induced narcolepsy [5]), and homo sapiens is only 32.5.
So it seems easily possible that this yeast containing vaccine with a powerful new adjuvant is creating autoantibodies that affect copper transport to the heart, due to molecular mimicry between yeast and human proteins. This can explain the huge increase in myocardial infarction occurrence following the administration of this vaccine. Yet the vaccine has been approved.
The FDA Briefing Document (Sep 13 2017) for the FDA VRBPAC meeting below details supraventricular tachycardia and tachyarrhythmia as serious adverse events (SAE) in SHINGRIX vaccinated subjects, detected during vaccine clinical studies.
https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMateri...
The vaccine package insert (Revised: 10/2017) [2], omits any reference to supraventricular tachycardia or tachyarrhythmia. Thus doctors who administer this vaccine are being kept in the dark about these SAEs. The Vaccine Adverse Event Reporting System (VAERS) depends on doctors reporting adverse events. Underreporting is a known problem with these passive surveillance methods. Hiding information from doctors only makes the problem worse.
The SHINGRIX vaccine contains Chinese Hamster Ovary (CHO) cell proteins used to produce the vaccine. Once again, autoimmunity [7] due to molecular mimicry between human and CHO proteins could be the cause of the SAEs.
Such vaccine approvals despite obvious safety problems detected during clinical trials, prove that vaccine regulators are not serious about safety at all.
References
1. FDA. Heplisav-B package insert [Internet]. 2017. Available from: https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedPr...
2. FDA. SHINGRIX vaccine package insert [Internet]. 2017. Available from: https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedPr...
3. UniProt: the universal protein knowledgebase. Nucleic Acids Res. 2017 Jan 4;45(D1):D158–69.
4. Arumugham V. Significant protein sequence alignment between peanut allergen epitopes and vaccine antigens [Internet]. 2016. Available from: https://www.zenodo.org/record/1034555
5. Ahmed SS, Volkmuth W, Duca J, Corti L, Pallaoro M, Pezzicoli A, et al. Antibodies to influenza nucleoprotein cross-react with human hypocretin receptor 2 (ABSTRACT ONLY). Sci Transl Med. 2015;7(294):294ra105–294ra105.
6. Nath R. Copper deficiency and heart disease: Molecular basis, recent advances and current concepts. Int J Biochem Cell Biol. 1997;29(11):1245–54.
7. Arumugham V. Cancer immunology, bioinformatics and chemokine evidence link vaccines contaminated with animal proteins to autoimmune disease: a detailed look at Crohn’s disease and Vitiligo [Internet]. 2017. Available from: https://www.zenodo.org/record/1034777
Competing interests: No competing interests