Gardasil serious adverse events

REVIEW

Stillo, M., Carrillo Santisteve, P., & Lopalco, P. L. (2015)

Safety of human papillomavirus vaccines: a review

Expert Opinion on Drug Safety 14(5), pp. 697–712

Published online: 18 Feb 2015

DOI: https://doi.org/10.1517/14740338.2015.1013532

SAEs are generally defined as any medical occurrence that is life-threatening, requires or prolongs hospital admission, results in disability, incapacity or death.

Harris et al. described an incidence of 7.5% (n = 10) SAEs following qHPVv vaccination, including reports of anaphylaxis, seizures, thrombocytopenia and a fatal case. Further review found that these reports were attributable to pre-existing conditions and no causal relation was attributable to the vaccine.

In both vaccine and placebo groups, injection site symptoms were the most commonly reported, however, the incidence in vaccine groups is often significantly higher than in the control groups. In Block et al. study, the proportion of individuals reporting an injection site AE was higher in qHPVv (82.9%) and aluminium-containing placebo recipients (77.4%) compared with non-aluminium-containing vaccine recipients (49%).

Bivalent (bHPVv) vs quadrivalent (qHPVv) vaccine

A bivalent one (protects against two HPV types), a quadrivalent one (protects against four HPV types), and a nonavalent one (protects against nine HPV types).

Since 2021, the National Health Service (NHS) in the UK has been offering Gardasil 9 to

• Children aged 12–13 years old

• Girls under the age of 25 who did not receive the vaccine at age 12 or 13

• Boys born on or after September 1, 2006

• People at higher risk from HPV, including:

  • People living with HIV

  • Commercial sex workers

  • Men under 45 who have sex with men