CPHA Canvax
CPHA Canvax

Abstract

BACKGROUND AND OBJECTIVES: Human papillomavirus is the most common sexually transmitted infection in the United States and causes certain anogenital and oropharyngeal cancers. The 9-valent human papillomavirus vaccine (9vHPV) provides protection against additional types not included in the quadrivalent vaccine. We conducted near real-time vaccine safety surveillance for 24 months after the vaccine became available in the Vaccine Safety Datalink.

METHODS: Immunizations and adverse events were extracted weekly from October 2015 to October 2017 from standardized data files for persons 9 to 26 years old at 6 Vaccine Safety Datalink sites. Prespecified adverse events included anaphylaxis, allergic reaction, appendicitis, Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, injection site reaction, pancreatitis, seizure, stroke, syncope, and venous thromboembolism. The observed and expected numbers of events after 9vHPV were compared weekly by using sequential methods. Both historical and concurrent comparison groups were used to identify statistical signals for adverse events. Unexpected signals were investigated by medical record review and/or additional analyses.

RESULTS: During 105 weeks of surveillance, 838 991 doses of 9vHPV were administered. We identified unexpected statistical signals for 4 adverse events: appendicitis among boys 9 to 17 years old after dose 3; pancreatitis among men 18 to 26 years old; and allergic reactions among girls 9 to 17 years old and women 18 to 26 years old after dose 2. On further evaluation, which included medical record review, temporal scan analysis, and additional epidemiological analyses, we did not confirm signals for any adverse events.

CONCLUSIONS: After 2 years of near real-time surveillance of 9vHPV and several prespecified adverse events, no new safety concerns were identified.


Web link

Near Real-Time Surveillance to Assess the Safety of the 9-Valent Human Papillomavirus Vaccine

Related Resources

Bookmark

Evidence

Link

Category

Vaccine Safety and Development,Vaccine Safety,Vaccine Safety,Adverse Events Following Immunization (AEFI),Monitoring and Surveillance,Vaccine Monitoring and Surveillance,Vaccine Monitoring,Vaccine Preventable Diseases,Communicable Diseases,Human Papillomavirus (HPV) Vaccine Safety and Development
Vaccine Safety
Vaccine Safety
Adverse Events Following Immunization (AEFI)
Monitoring and Surveillance
Vaccine Monitoring and Surveillance
Vaccine Monitoring
Vaccine Preventable Diseases
Communicable Diseases
Human Papillomavirus (HPV)

0 Comments

Using the comment box below, provide your feedback for this resource. Tell the immunization community how you used the resource, what worked, what didn't and the changes you made. The feedback provided will help inform the immunization community and improve upon the resource made available on CANVax.

All comments are anonymous. Submitted comments will be reviewed for approval by the CANVax team to ensure it meets content submission guidelines. Please note that although CANVax aims to approve comments in a timely manner, volume may result in delays.