Two New CDC Gardasil®9 HPV Vaccine Safety Studies Published

These are the first published post-licensure safety studies on Gardasil 9

On November 18, Pediatrics published the first post-licensure safety monitoring reviews on Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant; 9vHPV) from CDC and FDA’s Vaccine Adverse Event Reporting System (VAERS) and CDC’s Vaccine Safety Datalink (VSD). The separate reviews looked at adverse events following Gardasil 9 from December 2014 through December 2017, and October 2015 through October 2017, respectively.

Credit: Getty Images. Stock photo (posed by model).

Overall, the analyses support the favorable safety profile that was established in pre-licensure clinical trials for Gardasil 9, and did not identify any new or unexpected safety concerns.

Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States. Most infections are asymptomatic and become undetectable, but some can be persistent and can progress to cancer in both women and men later in life. Gardasil 9 is the only HPV vaccine available in the United States and provides protection against 9 types of cancer-causing human papillomaviruses.

These analyses represent the largest, most comprehensive post-licensure safety data on Gardasil 9 and add to the body of evidence that overwhelmingly supports HPV vaccine safety.

Read the articles for free in Pediatrics:

From VAERS: Safety of the 9-Valent Human Papillomavirus Vaccine.
Researchers reviewed 7,244 reports submitted to VAERS following HPV vaccination from December 2014 through December 2017. Of those reports, around 97% were classified as non-serious, and around 3% were considered serious. The analysis did not detect any new or unexpected safety concerns.
From VSD: Near Real-Time Surveillance to Assess the Safety of 9-valent Human Papillomavirus Vaccine.

VSD conducted near-real time surveillance from October 2015 through October 2017, looking at 11 pre-specified adverse events. During this two-year time period, nearly 840,000 doses were administered to people aged 9-26 years at six VSD sites. The analysis did not identify any new or unexpected safety concerns.

Learn more about CDC's work to monitor the safety of HPV Vaccine: