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Are the VAERS-included reactions following the human papillomavirus immunization correlated to the number of vaccine doses?


 Department of Medicine, Nazarbayev University School of Medicine, Nur-Sultan, Kazakhstan

Date of Submission22-Mar-2020
Date of Acceptance08-Apr-2020
Date of Web Publication06-Oct-2020

Correspondence Address:
Dimitri Poddighe,
Department of Medicine, School of Medicine, Nazarbayev University, Kerei-Zhanibek Str., 5/1, Nur-Sultan 010000
Kazakhstan
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/picr.PICR_69_20



How to cite this URL:
Poddighe D. Are the VAERS-included reactions following the human papillomavirus immunization correlated to the number of vaccine doses?. Perspect Clin Res [Epub ahead of print] [cited 2020 Oct 23]. Available from: https://www.picronline.org/preprintarticle.asp?id=297337



Sir,

Through their recent analysis of VAERS database as regards the individuals who were immunized with human papillomavirus (HPV) vaccine, Neha et al. did not identify any new/unexpected safety concern. A large variety of clinically significant adverse events (AEs) following (temporally) the HPV immunization were retrieved by these authors; among those, syncope was the most common AE documented after this vaccination, in terms of cumulative reporting odds ratio (ROR) value. Moreover, several additional “autonomic/neurological” manifestations were reported as well, such as dizziness (following syncope, in terms of cumulative ROR), headache, abasia, paresthesia, anxiety, asthenia/fatigue, (unspecified) general malaise, and arthralgia/myalgia.[1] Some of those could be interpreted as somatoform (“pseudo-neurological”) disorders since it is not possible to diagnose any specific or well-defined clinical condition in most cases.[2]

Some years ago, we described a case series of female adolescents developing severe somatoform and dysautonomic syndromes temporally related to HPV vaccination; interestingly, only 4 out of 18 patients manifested their complaints after the first dose.[3] Therefore, it would be interesting to analyze these AEs with respect to the number of administered doses of HPV vaccine, in order to assess if there is any correlation between the reports number and this specific aspect.

Indeed, recent evidences supported the effectiveness of HPV vaccine despite a reduction of the doses number. Brotherton et al. performed a statistical analysis of the quadrivalent HPV vaccine effectiveness, using and linking several national Australian registries, and they correlated the data regarding the number of HPV vaccine doses (0, 1, 2, and 3 doses) with the diagnoses of high-grade cervical intraepithelial neoplasia: they could conclude that “one dose had comparable effectiveness as two or three doses in preventing high-grade disease in a high coverage setting.”[4] Very recently, Markowitz et al. assessed the prevalence of HPV serotypes in young women (aged 20–29 years), who were screened for cervical cancer, and considered their immunization status with the quadrivalent HPV vaccine. Among women who received only 1 dose before 18 years of age, the prevalence of the four vaccine serotypes was 0.5%, which was not different from the age-matched women immunized with 2 or 3 doses.[5]

Therefore, reducing the dose schedule of HPV immunization seems to be a feasible and reasonable approach: in addition to containing the healthcare-related costs and further promoting the acceptance of this important vaccination, also the number of AEs reports might be reduced in future.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Neha R, Subeesh V, Beulah E, Gouri N, Maheswari E. Postlicensure surveillance of human papillomavirus vaccine using the Vaccine Adverse Event Reporting System, 2006-2017. Perspect Clin Res 2020;11:24-30.  Back to cited text no. 1
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2.
Poddighe D, Castelli L, Marseglia GL, Bruni P. A sudden onset of a pseudo-neurological syndrome after HPV-16/18 AS04-adjuvated vaccine: Might it be an autoimmune/inflammatory syndrome induced by adjuvants (ASIA) presenting as a somatoform disorder? Immunol Res 2014;60:236-46.  Back to cited text no. 2
    
3.
Palmieri B, Poddighe D, Vadalà M, Laurino C, Carnovale C, Clementi E. Severe somatoform and dysautonomic syndromes after HPV vaccination: Case series and review of literature. Immunol Res 2017;65:106-16.  Back to cited text no. 3
    
4.
Brotherton JM, Budd A, Rompotis C, Bartlett N, Malloy MJ, Andersen RL, et al. Is one dose of human papillomavirus vaccine as effective as three? A national cohort analysis. Papillomavirus Res 2019;8:100177.  Back to cited text no. 4
    
5.
Markowitz LE, Naleway AL, Klein NP, Lewis RM, Crane B, Querec TD, et al. Human papillomavirus vaccine effectiveness against HPV infection: Evaluation of one, two, and three doses. J Infect Dis 2020;221:910-8.  Back to cited text no. 5
    




 

 
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