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Clinical Rheumatology

, Volume 36, Issue 4, pp 975–975 | Cite as

Vaccine-related serious adverse events might have been under-recognized in the pivotal HPV vaccine randomized trial

  • Manuel Martínez-Lavín
Letter to the Editor

Keywords

Chronic Illness Contingency Table Overwhelming Majority Safety Analysis Vaccine Safety 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

To the Editor:

After seeing several healthy girls developing a severe chronic illness soon after HPV vaccination [1], I analyzed all HPV vaccine randomized controlled trials.

The overwhelming majority of pre-licensure HPV vaccine randomized trials did not use inert placebo as comparator. The largest nine-valent HPV immunization trial [2] compared the newly developed nine-valent HPV vaccine vs. the four-valent HPV formulation. The innovative nine-valent HPV dose has more than double HPV virus-like particles and aluminum adjuvant than the previous formulation. Double-blind safety analysis contrasted 7071 subjects immunized with the nine-valent vaccine vs. 7078 who had the four-valent dose. The nine-valent cohort had significantly more systemic serious adverse events; n = 233 (3.3%) vs. n = 183 (2.6%) in the other group. Our calculated 2 × 2 contingency table p value was 0.0125. Oddly, only two subjects (0%) in each group were judged to have a vaccine-related serious adverse event. The authors did not comment on this incongruity.

This discrepancy arising from a pivotal large randomized double-blind trial suggests that nine-valent HPV vaccine-related serious adverse events were under-recognized. This emerging information casts further doubt on HPV vaccine safety.

Notes

Compliance with ethical standards

Disclosures

None.

References

  1. 1.
    Martínez-Lavín M, Martínez-Martínez LA, Reyes-Loyola P (2015) HPV vaccination syndrome. A questionnaire-based study. Clin Rheumatol 34:1981–1983CrossRefPubMedGoogle Scholar
  2. 2.
    Joura EA, Giuliano AR, Iversen OE et al (2015) A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med 372:711–723CrossRefPubMedGoogle Scholar

Copyright information

© International League of Associations for Rheumatology (ILAR) 2017

Authors and Affiliations

  1. 1.Rheumatology DepartmentNational Institute of CardiologyMexico CityMexico

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