Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant - An overview

Overview

The human papillomavirus bivalent (types 16 and 18) recombinant vaccine has been developed to prevent oncogenic human papillomavirus (HPV) types 16 and 18, which can cause cervical cancer, cervical intraepithelial neoplasia or CIN (abnormal growth of cells on the cervix of the uterus) grade 2 or worse, adenocarcinoma in situ (abnormal cells in the glandular tissue that look like cancer tissue), and cervical intraepithelial neoplasia grade 1. It has been shown to directly reduce the incidence rates of cervical cancer and is non-infectious and AS04-adjuvanted. The recombinant human papillomavirus bivalent (Types 16 and 18) vaccine was approved by the Food and Drug Administration (FDA) on October 16, 2009.

Drug Group

The recombinant human papillomavirus bivalent (types 16 and 18) vaccine is one of a group of human papillomavirus vaccines. These vaccinations protect against illnesses caused by specific varieties of the human papillomavirus (HPV).

Indications

The recombinant human papillomavirus bivalent (types 16 and 18) vaccine is recommended to prevent the following diseases, which are brought on by carcinogenic HPV types 16 and 18:

• Cervical cancer.

• Adenocarcinoma in situ and cervical intraepithelial neoplasia (CIN) of grade 2 or worse.

• Cervical intraepithelial neoplasia (CIN) of grade 1.

The recombinant human papillomavirus bivalent (Types 16 and 18) vaccine is allowed for use in girls aged nine to 25.

Restrictions on Usage and Efficiency

• Not all HPV types are protected against illness with the recombinant human papillomavirus bivalent (types 16 and 18) vaccine.

• There is no evidence that the recombinant human papillomavirus bivalent (types 16 and 18) vaccine protects against diseases caused by vaccine- and non-vaccine-resistant HPV strains that a woman has already been exposed to through sexual activity.

Contraindications

It is contraindicated in the event of severe allergic reactions to any recombinant human papillomavirus bivalent (types 16 and 18) vaccine component, including anaphylaxis (a severe allergic reaction).

Dosage Forms and Available Strengths

The recombinant human papillomavirus bivalent (types 16 and 18) vaccine is available in single-dose syringes prefilled with a 0.5 mL (milliliter) injectable suspension.

Warnings and Precautions

• Syncope: Vaccine recipients carry the risk of syncope (fainting), which can result in falls and seizure (uncontrolled electrical activity in the brain)- like behavior. They should be monitored for 15 minutes following vaccination. Restoring cerebral perfusion (blood flow to the brain) while maintaining a supine or Trendelenburg position (the patient is in a low-head position with high legs) can help treat syncope, which is typically transitory.

• Latex: Prefilled syringe tip caps made of natural rubber latex can potentially trigger allergic reactions.

• Managing and Preventing Vaccine-Related Allergic Reactions: Before administering the recombinant human papillomavirus bivalent vaccine (types 16 and 18), healthcare providers should review the patient's immunization history for potential vaccine hypersensitivity (exaggerated immune response) and prior adverse reactions. They should also ensure a thorough assessment of the benefits and risks and provide immediate medical treatment and supervision in the event of an anaphylactic reaction.

For Patients

What Is Cervical Cancer?

• A kind of cancer that develops in the cervix, the lower portion of the uterus that joins the vagina, is called cervical cancer. Usually, aberrant cells first arise in the cervical tissue before cancer does, and they develop gradually over time.

• The human papillomavirus (HPV), which is spread through sexual contact, is the primary cause of cervical cancer.

• Pelvic pain, irregular vaginal discharge, and vaginal bleeding are among the symptoms that may develop as the disease advances but may not show up in the early stages. Sexually transmitted illnesses, smoking, having several sexual partners, and having intercourse when young are risk factors for cervical cancer.

• Cervical cancer consequences include severe pain, renal failure, blood clots, bleeding, fistula (an abnormal connection between two body parts), early menopause, radiotherapy-induced constriction of the vagina, and lymphoedema (swelling due to the buildup of lymph fluid in the tissues).

How Does the Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant Work?

The human papillomavirus bivalent (types 16 and 18) recombinant vaccine works by inducing the production of antibodies in the body that attach to the virus and stop it from spreading to other cells. Recombinant DNA or deoxyribonucleic acid technology is manufactured from the HPV main capsid (L1) protein. Inactive HPV proteins are contained in virus-like particles (VLPs), which are non-infectious and non-cancerous when the L1 proteins self-assemble. When used as prescribed, these VLPs generate neutralizing antibodies that help stop HPV-related cervical cancer, adenocarcinoma, and neoplasia (abnormal growth). For girls aged 15 to 25, the vaccination has a 95 to 99 percent efficacy rate against cervical disease caused by HPV types 16 and 18.

What Are the Benefits of the Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant?

The recombinant human papillomavirus bivalent vaccine (types 16 and 18) offers the following advantages:

• Prevention of Cervical Cancer: The vaccine is recommended to protect against oncogenic HPV types 16 and 18, which are known to cause cervical cancer.

• Prevention of Cervical Intraepithelial Neoplasia (CIN): It aids in the prevention of adenocarcinoma in situ and cervical intraepithelial neoplasia (CIN), grade 1, grade 2, or severe.

• High Efficacy: The HPV 16 and 18 vaccination has shown high efficacy in preventing CIN 2+ linked to HPV 16 and 18 in randomized, double-blind, phase II or III trials involving women aged 15 to 25.

• Possibility to Prevent HPV-Associated Malignancies: Over 90 percent of HPV-related malignancies may be avoided with the use of the HPV vaccination.

• Reduction in HPV Infections: Since the 2006 recommendation for HPV vaccination, there has been an 88 percent decrease in teen girls' infections and an 81 percent decrease in young adult women's infections with the HPV strains that cause the majority of HPV malignancies and genital warts (growth around the genital region).

• Cross-Protection: The vaccine also offers cross-protection against newly acquired HPV 45 or HPV 31 infections and against infections that last six months.

How Is the Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine Administered?

An intramuscular injection called the recombinant human papillomavirus bivalent vaccine (types 16 and 18) is given in a clinic or doctor's office. Three doses of the vaccine are administered; the first is administered to individuals between the ages of nine and 25. The second dose is administered a month after the initial shot, and the third dose follows six months later. To completely protect against the sickness, it is imperative to take all prescribed dosages. The upper arm's deltoid region is the recommended administration site.

What Are the Side Effects of the Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant?

More than 20 percent of the recombinant human papillomavirus bivalent vaccine (types 16 and 18) patients experienced the most frequent local adverse reactions, such as:

• Pain.

• Redness.

• Swelling at the injection site.

The most prevalent general adverse effects were

• Fatigue.

• Headache.

• Myalgia (muscle pain).

• Gastrointestinal symptoms.

• Arthralgia (joint pain).

What Are the Things to Inform the Doctor Before Taking the Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant?

• Those who have had a deadly allergic reaction to any of the vaccine's ingredients or a previous dosage or who suffer from severe allergies such as latex allergies should not receive the HPV vaccine.

• The HPV vaccine is not advised for pregnant women, although it is for nursing mothers. To learn more about the vaccine's effects on expectant mothers, it is advisable to speak with a healthcare provider if women are expecting while receiving the vaccine.

• Mildly ill people can receive a dose of the HPV vaccination; however, people who are moderately or critically ill should wait to get better.

• Inform the doctor about all of the medical histories before getting this immunization, including any immune system diseases (such as those brought on by HIV or human immunodeficiency virus infection), specific tumors (including leukemia, which is a blood cancer that defines a rise in white blood cells) or lymphoma (a cancer of the lymphatic system), cancer, or radiation therapy, and current fever or illnesses.

Dietary Considerations

Adhere to the doctor's instructions regarding any restrictions on food, beverages, or activity.

Missed Dose

If patients miss or get behind on a recombinant human papillomavirus bivalent vaccine (types 16 and 18) booster dose, it is not necessary to start over. Instead, contact the doctor right away for the next dose.

Overdose

The likelihood of overdosing on the recombinant human papillomavirus bivalent vaccine (types 16 and 18) is improbable.

Storage and Handling

The recombinant human papillomavirus bivalent vaccine (types 16 and 18) should be refrigerated, not frozen, and kept between 2°C (degree Celsius) and 8°C (36°F (degree Fahrenheit) and 46°F).

Disposal:

Throw away any frozen recombinant human papillomavirus bivalent vaccines. While being stored, a white deposit with a clear, colorless supernatant may form, but it is not deteriorating.

For Doctors

What Are the Pharmacological Actions of the Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant?

Pharmacodynamics:

No data are available regarding the pharmacodynamics of the recombinant human papillomavirus bivalent vaccine (types 16 and 18).

Mechanism of Action

Animal studies demonstrated that the formation of IgG-neutralizing antibodies against the HPV-L1 capsid proteins produced by vaccination may mediate the effectiveness of L1 VLP vaccinations.

Pharmacokinetics

No data are available regarding the pharmacokinetics of the recombinant human papillomavirus bivalent vaccine (types 16 and 18).

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

The immunogenic human papillomavirus bivalent vaccine (types 16 and 18) did not affect the fertility of female rats and has not been found to have any carcinogenic or mutagenic characteristics.

What Are the Drug Interactions of the Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant?

• Concomitant Vaccine Administration: The study warns against combining the recombinant human papillomavirus bivalent vaccine (types 16 and 18) with other vaccinations in the same syringe or vial and does not offer data on concurrent use.

• Hormonal Contraceptives: According to the study, the recombinant human papillomavirus bivalent vaccine (types 16 and 18)'s effectiveness was comparable to that of individuals who did not take hormonal contraceptives among 7,693 participants who were between the ages of 15 and 25 and were taking it.

• Immunosuppressive Therapies: Immunosuppressive treatments, such as radiation, antimetabolites, alkylating agents, cytotoxic medications, and higher-than-physiologic dosages of corticosteroids, can lessen the body's immunological response to the recombinant human papillomavirus bivalent vaccine (types 16 and 18).

Clinical Studies

A phase III double-blind, randomized controlled trial found that the recombinant human papillomavirus bivalent vaccine (types 16 and 18) was 90.4 percent effective against CIN2+ lesions carrying HPV 16 and 18. Additionally, there is some degree of cross-protection between HPV types 31 and 45, which results in defense against roughly eighty percent of cervical cancer cases. Furthermore, these vaccinations remain effective for five years. The vaccine's efficacy is primarily focused on protecting against HPV-related SIL (squamous intraepithelial lesion) and persistent infection by the HPV types used. The vaccines are well-tolerated, highly immunogenic, and generate high titers of neutralizing antibodies against HPV types 16 and 18, resulting in high efficacy against CIN2+ lesions containing HPV 16 and HPV 18.

Use in Specific Populations

• Pregnancy: According to animal studies, the recombinant human papillomavirus bivalent vaccine (types 16 and 18) has minimal to no negative effects on the growing fetus, making it typically safe to use during pregnancy. However, these findings are insufficient to support its use during pregnancy. As a result, vaccinations ought to wait until after the pregnancy is over.

• Breastfeeding: The serological study demonstrates that anti-HPV-16 and anti-HPV274-18 antibodies are transferred through milk in lactating rats; however, it is unknown if the recombinant human papillomavirus bivalent vaccine (types 16 and 18) is excreted in human milk, so breastfeeding mothers need to use caution.

• Pediatric Use: The recombinant human papillomavirus bivalent vaccine (types 16 and 18) is unknown if it is safe and effective for pediatric patients aged nine to seventeen.

• Geriatric Use: The recombinant human papillomavirus bivalent vaccine (types 16 and 18) has not been approved for use in older subjects since clinical studies were not conducted long enough to evaluate the drug's response in these subjects.

• Immunocompromised Individuals: The immunological response to the recombinant human papillomavirus bivalent vaccine (types 16 and 18) may be reduced in people with immunocompromised conditions.