Initial U.S. Approval: 2014
GARDASIL 9 is a vaccine indicated… for the prevention of the following diseases:
– Cervical, vulvar, vaginal, anal, oropharyngeal and other head and
neck cancers caused by Human Papillomavirus…
– Genital warts… caused by HPV…
– And…precancerous or dysplastic lesions caused by HPV…
The oropharyngeal and head and neck cancer indication is approved under accelerated approval… contingent upon verification and description of clinical benefit in a confirmatory trial.
GARDASIL 9 has not been demonstrated to provide protection against disease caused by:
– HPV types not covered by the vaccine.
– HPV types to which a person has previously been exposed through sexual activity.
Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV…
WARNINGS AND PRECAUTIONS
Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination.
Serious adverse events [were reported in]… 2.3% of the population… pyrexia, allergy to vaccine, asthmatic crisis, and headache.
Systemic Autoimmune Disorders
2.2%… of GARDASIL 9 recipients… reported new medical conditions…
Postmarketing Experience
– Vomiting
– Urticaria
– Autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, lymphadenopathy.
– Pulmonary embolus [blood clot].
– Pancreatitis.
– Asthenia, chills, death, malaise.
– Autoimmune diseases, hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm.
– Arthralgia, myalgia.
– Acute disseminated encephalomyelitis, Guillain-Barré syndrome, motor neuron disease, paralysis, seizures, transverse myelitis.
– Cellulitis.
– Deep venous thrombosis.
[R]ates of pregnancies that resulted in a miscarriage were 27.4%… in subjects who received GARDASIL 9…
Each 0.5-mL dose of the vaccine also contains approximately 500 mcg of aluminum (provided as AAHS)…
Efficacy of GARDASIL 9… is thought to be mediated by humoral immune responses… the exact mechanism of protection is unknown.
GARDASIL 9 has not been evaluated for the potential to cause carcinogenicity, genotoxicity or impairment of male fertility.