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Safety of the 9-Valent Human Papillomavirus Vaccine.

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.

SUBMITTER: Shimabukuro TT

PROVIDER: S-EPMC6935554 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Safety of the 9-Valent Human Papillomavirus Vaccine.

Shimabukuro Tom T TT Su John R JR Marquez Paige L PL Mba-Jonas Adamma A Arana Jorge E JE Cano Maria V MV

Pediatrics 20191118 6

<h4>Background</h4>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).<h4>Methods</h4>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 r ...[more]

PMID: 31740500

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Project description:In 2014, the Food and Drug Administration approved a new human papillomavirus 9-valent vaccine (9vHPV), targeting nine HPV types: HPV types 6, 11, 16, and 18, which are also targeted by the quadrivalent HPV vaccine (qHPV), plus five additional high cancer risk HPV types (HPV types 31, 33, 45, 52, and 58). The aim of the current study was to systematically retrieve, qualitatively and quantitatively pool, as well as critically appraise all available evidence on 9vHPV from randomized controlled trials (RCTs). We conducted a systematic review of the literature on 9vHPV efficacy, immunogenicity and safety, as well as a systematic search of registered, completed, and ongoing RCTs. We retrieved and screened 227 records for eligibility. A total of 10 publications reported on RCTs' results on 9vHPV and were included in the review. Sixteen RCTs on 9vHPV have been registered on RCT registries. There is evidence that 9vHPV generated a response to HPV types 6, 11, 16 and 18 that was non-inferior to qHPV. Vaccine efficacy against five additional HPV type-related diseases was directly assessed on females aged 16-26 years (risk reduction against high-grade cervical, vulvar or vaginal disease = 96·7%, 95% CI 80·9%-99·8%). Bridging efficacy was demonstrated for males and females aged 9-15 years and males aged 16-26 years (the lower bound of the 95% CIs of both the geometric mean titer ratio and difference in seroconversion rates meeting the criteria for non-inferiority for all HPV types). Overall, 9vHPV has been proved to be safe and well tolerated. Other RCTs addressed: 9vHPV co-administration with other vaccines, 9vHPV administration in subjects that previously received qHPV and 9vHPV efficacy in regimens containing fewer than three doses. The inclusion of additional HPV types in 9vHPV offers great potential to expand protection against HPV infection. However, the impact of 9vHPV on reducing the global burden of HPV-related disease will greatly depend on vaccine uptake, coverage, availability, and affordability.

Project description:Human papillomavirus is considered the causative factor for cervical cancer, which accounts for approximately 5% of the global cancer burden and more than 600,000 new cases annually that are attributable to HPV infection worldwide. The first-generation prophylactic HPV vaccines, Gardasil® and Cervarix®, were licensed approximately a decade ago. Both vaccines contain the most prevalent high-risk types, HPV16 and 18, which are associated with 70% of cervical cancer. To further increase the type coverage, 5 additional oncogenic HPV types (31, 33, 45, 52 and 58) were added to the existing Gardasil-4 to develop a 9-valent HPV vaccine (9vHPV), Gardasil 9®, increasing the potential level of protection from ∼70% to ∼90%. The efficacy of the vaccine lies primarily in its ability to elicit type-specific and neutralizing antibodies to fend off the viral infection. Therefore, type-specific and neutralizing murine monoclonal antibodies (mAbs) were used to quantitate the antigenicity of the individual vaccine antigens and to measure the antibody levels in the serum samples from vaccinees in a type- and epitope-specific manner in a competitive immunoassay. Assays for 9vHPV are extended from the proven platform used for 4vHPV by developing and adding new mAbs against the additional types. In Phase III clinical trials, comparable safety profile and immunogenicity against the original 4 types were demonstrated for the 9vHPV vaccine, and these were comparable to the 4vHPV vaccine. The efficacy of the 9vHPV vaccine was established in trials with young women. Immunobridging for younger boys and girls was performed, and the results showed higher immunogenicity in the younger age group. In a subsequent clinical trial, the 2-dose regimen of the 9vHPV vaccine used among girls and boys aged 9-14 y showed non-inferior immunogenicity to the regular 3-dose regimen for young women (aged 16-26 years). Overall, the clinical data and cost-effectiveness analysis for the 9vHPV vaccine support its widespread use to maximize the impact of this important, life-saving vaccine.

Project description:IntroductionThe World Health Organization (WHO) recommends that human papillomavirus (HPV) vaccination programs are established to be cost-effective before implementation. WHO recommends HPV vaccination for girls aged 9-13 years to tackle the high burden of cervical cancer. This review examined the existing evidence on the cost-effectiveness of the 9-valent HPV vaccine within a global context.MethodsThe literature search covering a period of January 2000 to 31 July 2019 was conducted in PubMed and Scopus bibliographic databases. A combined checklist (i.e., WHO, Drummond and CHEERS) was used to examine the quality of eligible studies. A total of 12 studies were eligible for this review and most of them were conducted in developed countries.ResultsDespite some heterogeneity in approaches to measure cost-effectiveness, ten studies concluded that 9vHPV vaccination was cost-effective and two did not. The addition of adolescent boys into immunisation programs was cost effective when vaccine price and coverage was comparatively low. When vaccination coverage for females was more than 75%, gender neutral HPV vaccination was less cost-effective than vaccination targeting only girls aged 9-18 years. Multi cohort immunization approach was found cost-effective in the age range of 9-14 years. However, the upper age limit at which vaccination was found not cost-effective requires further evaluation. This review identified duration of vaccine protection, time horizon, vaccine price, coverage, healthcare costs, efficacy and discounting rates as the most dominating parameters in determining cost-effectiveness.ConclusionsThese findings have implications in extending HPV immunization programs whether switching to the 9-valent vaccine or the inclusion of adolescent boys' vaccination or extending the age of vaccination. Further, this review also supports extending vaccination programs to low-resource settings where vaccine prices are competitive, donor funding is available, burden of cervical cancer is high and screening options are limited.

Dataset Information

Safety of the 9-Valent Human Papillomavirus Vaccine.

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Safety of the 9-Valent Human Papillomavirus Vaccine.

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