Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine

Abstract

N JUNE 8, 2006, THE FOOD and Drug Administration (FDA) licensed the quadrivalent human papillomavirus recombinant vaccine (qHPV) (Gardasil; Merck & Co, Inc, Whitehouse Station, New Jersey) for females aged 9 to 26 years to prevent infection with genital human papillomavirus (HPV) types 6, 11, 16, and 18. 1 Later that month, the Advisory Committee on Immunization Practices (ACIP) recommended routine vaccination of females aged 11 to 12 years with 3 doses of qHPV and catch-up vaccination for females aged 13 to 26 years. Doses are administered intramuscularly on a schedule of 0, 2, and 6 months. 2 The viruses HPV-16 and HPV-18 can cause cervical cancer, other anogenital cancers, and precancerous or dysplastic lesions and are responsible for about 70% of cervical cancers worldwide. 3 The viruses HPV-6 and HPV-11 are the most common causes of genital warts. Prior to licensure, clinical trials were conducted in more than 21 000 women. Vaccination with qHPV was 90% to 100% effective in preventing precancerous cervical, vaginal, and vulvar lesions and genital warts caused by infection with the relevant HPV types (6, 11, 16, or 18) in women aged 15 to 26 years who were uninfected prior to vaccination. 4,5 Additional immunogenicity and safety studies in 9-to 15-year-See also pp 781 and 795.

Detection of human papillomavirus L1 gene DNA fragments in postmortem blood and spleen after Gardasil<sup>®</sup> vaccination—A case report

“…A number of cases of possibly immune-based inflammatory neurodegenerative disorders involving the central nervous system, known as acute disseminated encephalomyelitis, following Gardasil ® injections have been reported in world literature [12][13][14][15][16][17][18]. Among 12,424 reported adverse events following Gardasil ® vaccination from June 1, 2006 through December 31, 2008, there were 32 deaths with a mean age of 18 years old, who died 2 to 405 days after the last Gardasil ® injection [19]. Medical records and autopsy reports on 20 of the 32 deaths were available for review and confirmed there were 4 unexplained deaths and 6 cardiac-related deaths [19].…”

“…Among 12,424 reported adverse events following Gardasil ® vaccination from June 1, 2006 through December 31, 2008, there were 32 deaths with a mean age of 18 years old, who died 2 to 405 days after the last Gardasil ® injection [19]. Medical records and autopsy reports on 20 of the 32 deaths were available for review and confirmed there were 4 unexplained deaths and 6 cardiac-related deaths [19]. No investigative work was attempted to confirm or to exclude any link of a death to Gardasil ® vaccination although there was disproportional reporting of syncope among the Gardasil ® recipients [19].…”

Acceptability of school requirements for human papillomavirus vaccine

“…12,13 Differences between HPV infection and other vaccine preventable diseases may contribute to resistance to school requirements. 9 HPV vaccines are primarily intended to prevent a genital cancer caused by a sexually transmitted virus.…”

Best vaccination practice and medically attended injection site events following deltoid intramuscular injection

“…One with quadrivalent human papilloma virus vaccine (Gardasil Ò ) 23 in which no additional clinical data were given and 2 24,25 with 23 valent pneumococcal polysaccharide vaccine (Pneumovax Ò ). The latter cases reported in females 59 and 76 years old respectively were diagnosed as pseudoseptic arthritis of the glenohumeral joint.…”