Assessing the safety of 9-valent human papillomavirus vaccine administration among pregnant women: adverse event reports in the Vaccine Adverse Event Reporting System (VAERS), 2014-2017 Open Access

Abstract

Introduction: There are over 79 million cases of human papillomavirus (HPV) in the United States (1).  Chronic cases of HPV can cause cervical, vulvar, vaginal, penile, anal, and oropharyngeal cancers (2).  Nine-valent human papillomavirus vaccine (9vHPV) can protect against the most prevalent disease types (3).  Although the HPV vaccine has not been causally associated with adverse outcomes of pregnancy or adverse events (AEs) in the developing fetus, it is not recommended that pregnant women receive it (4, 5).  However, some women of childbearing age might be inadvertently exposed during catchup vaccination (5-7).  This study aims to assess the safety of 9vHPV administration during pregnancy.

Methods: We searched the Vaccine Adverse Event Reporting System (VAERS) database, a national post-licensure vaccine safety surveillance system, for reports of pregnant women vaccinated with 9vHPV in the United States between December 10, 2014 and December 31, 2017 (8).  Reports and corresponding medical records (when available) were reviewed.  AEs were characterized as primary maternal, secondary maternal, primary infant, or secondary infant.  Primary maternal AEs were further classified as pregnancy-specific or nonpregnancy-specific.  Vaccination errors were noted.  Frequencies and percentages of AEs and vaccination errors were computed, and disproportionate reporting of AEs was assessed using proportional reporting ratios (PRRs) (9, 10).

Results: A total of 80 pregnancy reports were identified.  Sixty reports (73.2%) did not describe an AE and were submitted due to vaccine exposure during pregnancy.  The most frequently reported pregnancy-specific AE was spontaneous abortion (n = 3; 3.7%), followed by vaginal bleeding (n = 2; 2.4%).  Among nonpregnancy-specific AEs, injection site reaction (n = 3; 3.7%) was most common.  Just over one-fifth of reports described a vaccination error (n = 17; 21.3%).  The PRR analyses comparing 9vHPV and 4vHPV vaccines, as well as 9vHPV and inactivated influenza vaccines, did not reveal disproportional reporting for any AE.  Only codes for non-clinically important events exceeded the PRR threshold.

Discussion: No AE clusters or patterns of concern were observed among these pregnancy reports.  CDC routinely monitors the safety of 9vHPV in the United States and will continue to monitor the safety of this vaccine in pregnancy (11).

Table of Contents

Chapter I ...................................................................................................................................1

Background/Literature Review .............................................................................................1

Chapter II ................................................................................................................................10

Title, Authors, and Abstract ................................................................................................10

Introduction .........................................................................................................................12

Methods ...............................................................................................................................14

Results .................................................................................................................................18

Discussion ...........................................................................................................................20

Strengths & Limitations .................................................................................................23

Conclusion .....................................................................................................................24

References ...........................................................................................................................25

Tables ..................................................................................................................................36

 

Figures ................................................................................................................................40

About this Master's Thesis

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School	Rollins School of Public Health
Department	Epidemiology
Subfield / Discipline	Epidemiology - MPH & MSPH
Degree	M.S.P.H.
Submission	Master's Thesis
Language	English
Research Field	Health Sciences, Public Health Health Sciences, Epidemiology Health Sciences, Obstetrics and Gynecology
Keyword	Nine-valent human papillomavirus vaccine Epidemiology Adverse events Human papillomavirus Vaccination Surveillance 9vHPV Adverse event HPV Vaccine HPV9 Pregnant Vaccine safety Pregnancy
Committee Chair / Thesis Advisor	Omer, Saad B., Emory University
Committee Members	Moro, Pedro L., CDC
Partnering Agencies	Emory University schools, faculty or affiliated programs

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