Pharmaceutical Approval Update
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil)
Manufacturer: Merck & Company, Whitehouse Station, NJ
Indication: This vaccine is intended for the prevention of cervical cancer and genital warts (condyloma acuminata) caused by human papillomavirus (HPV) types 6, 11, 16, and 18, in girls and women nine to 26 years of age. It is not indicated for existing infections. The vaccine also protects against the following precancerous or dysplastic lesions:
- cervical adenocarcinoma in situ (noninvasive cervical cancer) (AIS)
- cervical intraepithelial neoplasia (CIN) grade 2 and grade 3
- vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3
- vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3
- cervical intraepithelial neoplasia (CIN) grade 1
Drug Class: The vaccine is prepared from the highly purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV types 6, 11, 16, and 18. The L1 proteins are produced by separate fermentations in recombinant Saccharomyces cere-visiae and self-assembled into VLPs. The fermentation process involves growth of S. cerevisiae on chemically defined fermentation media, which include vitamins, amino acids, mineral salts, and carbohydrates. The VLPs are released from the yeast cells by cell disruption and are purified by a series of chemical and physical methods. The purified VLPs are adsorbed on preformed aluminum-containing adjuvant (amorphous aluminum hydroxyphosphate sulfate).
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The vaccine is a sterile liquid suspension that is prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the adjuvant and the final purification buffer.
Uniqueness of Product: The vaccine protects against the virus that causes genital warts, which can lead to cancer. HPV infections are responsible for 70% of cases of cervical cancer, the second most common cancer among women worldwide. The vaccine is effective against four key types of HPV. Four clinical test programs involving 21,000 women around the world demonstrated that the vaccine was “nearly 100% effective” in preventing HPV-caused precancerous cervical, vaginal, and vulvar lesions as well as genital warts.
Precautions: As with any vaccine, this vaccine may not protect all recipients. This vaccine is not intended as a therapy for active genital warts, cervical cancer, CIN, VIN, or VaIN. It does not protect against diseases that are not caused by HPV, and it has not been shown to protect against diseases caused by non-vaccine HPV types.
Anaphylactic Reactions: As with all injectable vaccines, appropriate medical treatment should be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Fever: The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the severity of the symptoms and their etiology. Low-grade fever itself and mild upper respiratory infection are not generally contraindications to vaccination.
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Immunosuppression. Individuals with impaired immune responsiveness, whether a result of the use of immuno-suppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have a reduced antibody response to active immunization.
Hematological Disorders: As with intramuscular injections, this vaccine should not be given to individuals with bleeding disorders (e.g., hemophilia or thrombocytopenia) or to patients receiving anticoagulant therapy unless the potential benefits clearly outweigh the risks. If the vaccine is administered to such persons, it should be given with instructions to avoid the risk of hematoma following the injection.
Drug Interactions:
Use with Other Vaccines: Clinical studies indicate that this vaccine may be administered concomitantly (at a separate injection site) with hepatitis B vaccine (recombinant). Co-administration of this vaccine with other vaccines has not been studied.
Use with Hormonal Contraceptives: In clinical studies, 13,293 subjects (6,644 subjects receiving the vaccine and 6,649 subjects receiving placebo) who had follow-up visits after seven months used hormonal contraceptives, for a total of 17,597 person-years (65.1% of the total follow-up time in the study for these subjects). The use of the contraceptives or the lack thereof among the study participants did not alter the vaccine’s efficacy in this group using personal protective equipment (PPE).
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Use with Systemic Immunosuppressive Medication:
Immunosuppressive therapies, including irradiation, anti-metabolites, alkylating agents, cytotoxic drugs, and cortico-steroids, when used in greater than physiologic doses, may reduce the immune response to vaccines.
Dosage and Administration: Gardasil is given intramuscularly as three separate 0.5-ml doses: (1) at the elected date, (2) two months after the first dose, and (3) six months after the first dose.
The vaccine is injected into the deltoid region of the upper arm or in the higher anterolateral area of the thigh; it should not be injected intravascularly. Subcutaneous and intradermal administration have not been studied, and these techniques are therefore not recommended.
The prefilled syringe is intended for a single use only and for only one person. Single-use vials and a separate sterile syringe and needle must be used for each individual.
Commentary: Gardasil is the first vaccine approved by the Food and Drug Administration (FDA) to prevent cervical cancer and vulvar and vaginal precancers caused by HPV types 16 and 18 and to prevent low-grade and precancerous lesions and genital warts caused by types 6, 11, 16, and 18. It represents a major health breakthrough because it is the first vaccine designed to prevent cancer. In clinical studies, the vaccine prevented 100% of HPV 16-related and HPV 18-related cervical cancers in women who had not been previously exposed to the relevant HPV types. It also prevented 99% of cases of genital warts caused by HPV 6 and 11.
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In the U.S., approximately 10,000 cases of cervical cancer are diagnosed every year, and an average of 10 patients with the disease die each day. HPV types 16 and 18 account for approximately 70% of cases of cervical cancer, AIS, CIN stage 3, VIN stages 2 and 3 and VaIN stages 2 and 3. These types account for 50% of CIN 2 lesions. HPV 6 and 11 cause approximately 90% of cases of genital warts. Types 6, 11, 16, and 18 also cause 35% to 50% of all low-grade cervical, vaginal, and vulvar lesions (CIN I, VIN I, and VaIN I).
The vaccine does not reverse existing infections and does not seem to protect against the strains that account for the remaining 30% of cervical cancer cases. For sexually active patients, Pap smears may still show abnormalities that must be investigated. It can take decades for HPV infections to progress to cancer, and it may take that long to measure the benefits of the vaccine.
