Human Papillomavirus Quadrivalent (Type 6,11,16 &18) Vaccine, Recombinant
Overview
Human Papillomavirus (HPV) Quadrivalent Vaccine, Recombinant is a preventive vaccine designed to induce immune responses against four types of human papillomavirus: types 6 and 11, which are associated with genital warts, and types 16 and 18, which are associated with cervical cancer and other HPV‑related malignancies. The vaccine contains virus‑like particles produced by recombinant technology that mimic the outer protein coat of HPV without containing viral DNA, making it non‑infectious. When administered, these particles stimulate the immune system to produce antibodies that neutralize the corresponding HPV types, reducing the risk of persistent infection, precancerous lesions, and cancer. Quadrivalent HPV vaccines play a central role in public health immunisation programmes by decreasing the incidence of cervical cancer and other HPV‑related diseases in both females and males. The vaccine is typically given by intramuscular injection and elicits strong and durable antibody responses that provide long‑term protection against targeted HPV types when the full series is completed.
Background and Date of Approval
The first quadrivalent HPV vaccine, targeting HPV types 6, 11, 16, and 18, was approved by the United States Food and Drug Administration in 2006 for the prevention of cervical cancer and precancerous lesions caused by HPV types 16 and 18, and genital warts caused by HPV types 6 and 11. Regulatory authorities in other regions, including the European Medicines Agency, subsequently authorised the vaccine for similar indications in adolescents and adults. These approvals were based on pivotal clinical trials showing significant reductions in persistent infection, high‑grade cervical intraepithelial neoplasia, and genital warts in vaccine recipients compared with unvaccinated controls. Over time, HPV vaccination has been incorporated into routine immunisation schedules in many countries, with recommendations extending to both females and males to reduce the overall burden of HPV infection and related cancers.
Uses
Human Papillomavirus Quadrivalent Vaccine, Recombinant is indicated for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16 and 18, as well as the prevention of genital warts caused by HPV types 6 and 11 in males and females. It is typically administered prior to the onset of sexual activity to maximize preventive benefit, but catch‑up vaccination is recommended for older adolescents and young adults who were not vaccinated earlier. The vaccine is used in both females and males, with recommendations broadening over time to include older ages in certain jurisdictions based on clinical evidence and immunization policy.
Administration
The vaccine is administered by intramuscular injection, usually in the deltoid region. The standard schedule for the quadrivalent HPV vaccine consists of three doses given over a six‑month period: the second dose is administered one to two months after the first, and the third dose is given six months after the first dose. In some age groups and with updated guidance, a two‑dose schedule may be used when vaccination is initiated at younger ages, with the interval between doses adjusted according to local recommendations. Completion of the entire dosing series is important for optimal immunogenicity and long‑term protection.
Side Effects
Common side effects following vaccination include pain, redness, swelling, or itching at the injection site, low‑grade fever, headache, fatigue, nausea, dizziness, and muscle or joint pain. These reactions are generally mild and transient, resolving without intervention within a few days after vaccination. Syncope (fainting) may occur, particularly in adolescents, so appropriate observation after injection is recommended.
Warnings
Serious adverse events following vaccination are rare but may include severe allergic reactions (anaphylaxis) to vaccine components. Neurologic events have been reported post‑licensure but are not definitively causally associated with the vaccine. Individuals with a history of severe hypersensitivity to any component of the vaccine should not receive it. Vaccination should be deferred in individuals with moderate or severe acute illness until recovery. As with all new medical products, ongoing surveillance monitors for rare or long‑term adverse events.
Precautions
Before vaccination, clinicians should assess for history of severe allergic reactions to vaccines and current acute illnesses. There are no established clinically significant drug interactions that contraindicate receipt of the vaccine; however, immunocompromised individuals may have a reduced immune response. The quadrivalent HPV vaccine does not contain live virus, so it may be administered at the same visit as other inactivated or recombinant vaccines at different injection sites following standard practices. Routine precautionary measures include monitoring for immediate hypersensitivity after vaccination.
Expert Tips
Prescribers should confirm age and risk status and counsel patients and caregivers on the importance of completing the full vaccine series for maximum protection. Educate recipients about expected local and systemic reactions and the importance of remaining seated or observed briefly after injection to reduce risk related to syncope. Storage and handling should comply with manufacturer instructions and cold‑chain requirements. Coordination with routine immunization schedules helps optimize uptake. Clear documentation of doses and scheduled follow‑up enhances adherence and long‑term effectiveness.