Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Dec;144(6):e20191791.
doi: 10.1542/peds.2019-1791. Epub 2019 Nov 18.

Safety of the 9-Valent Human Papillomavirus Vaccine

Tom T Shimabukuro  1 , John R Su  2 , Paige L Marquez  2 , Adamma Mba-Jonas  3 , Jorge E Arana  2 , Maria V Cano  2
Affiliations

Safety of the 9-Valent Human Papillomavirus Vaccine

Tom T Shimabukuro et al. Pediatrics. 2019 Dec.

Abstract

Background: The 9-valent human papillomavirus vaccine (9vHPV) was approved for females and males aged 9 to 26 years in 2014. We analyzed postlicensure surveillance reports to the Vaccine Adverse Event Reporting System (VAERS).

Methods: We searched VAERS data for US reports of adverse events (AEs) after 9vHPV from December 2014 through December 2017. We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reporting. Physicians reviewed reports for selected prespecified conditions.

Results: VAERS received 7244 reports after 9vHPV: 31.2% among females, 21.6% among males, and for 47.2%, sex was not reported. Overall, 97.4% of reports were nonserious. Dizziness, syncope, headache, and injection site reactions were most commonly reported; the most commonly reported AEs were similar between females and males. Two reports of death after 9vHPV were verified; no information in autopsy reports or death certificates suggested a causal relationship with vaccination. Approximately 28 million 9vHPV doses were distributed during the study period; crude AE reporting rates were 259 reports per million 9vHPV doses distributed for all reports and 7 per million doses distributed for serious reports. Syncope (a known AE associated with human papillomavirus vaccination) and several types of vaccine administration errors (eg, administered at wrong age) exceeded the statistical threshold for empirical Bayesian data mining findings.

Conclusions: No new or unexpected safety concerns or reporting patterns of 9vHPV with clinically important AEs were detected. The safety profile of 9vHPV is consistent with data from prelicensure trials and from postmarketing safety data of its predecessor, the quadrivalent human papillomavirus vaccine.

PubMed Disclaimer

Conflict of interest statement

POTENTIAL CONFLICT OF INTEREST: Dr Arana currently works in Clinical Safety and Risk Management, Merck Research Laboratories, Merck & Co, on matters unrelated to the content of this article. During the time he worked on this article, he was employed by the Centers for Disease Control and Prevention. His work on the article ceased before his employment with Merck; the other authors have indicated they have no potential conflicts of interest to disclose.

Comment in

References

    1. Merck & Co, Inc. Gardasil 9 [Package Insert]. Whitehouse Station, NJ: Merck & Co, Inc; 2014
    1. Meites E, Kempe A, Markowitz LE. Use of a 2-dose schedule for human papillomavirus vaccination - updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2016; 65(49):1405–1408 - PubMed
    1. Petrosky E, Bocchini JA Jr, Hariri S,et al.; Centers for Disease Control and Prevention (CDC). Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2015; 64(11):300–304 - PMC - PubMed
    1. Markowitz LE, Dunne EF, Saraiya M,et al.; Centers for Disease Control and Prevention (CDC). Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP) [published correction appears in MMWR Recomm Rep. 2014;63(49):1182]. MMWR Recomm Rep. 2014;63(RR):1–30 - PubMed
    1. US Food and Drug Administration. Gardasil 9 [approval letter]. 2018. Available at: www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/U.... Accessed July 23, 2019

Substances