human papillomavirus vaccine, nonavalent

Action and Spectrum

Actions and Spectrum: 

• Introduction of Viral Proteins: The nonavalent HPV vaccine contains virus-like particles (VLPs) that resemble the HPV virus’s outer shell. These VLPs do not contain viral DNA, but they do contain viral proteins, including the L1 capsid protein. 
• Stimulation of Immune Response: When the vaccine is administered, the viral proteins in the VLPs stimulate the immune system. This stimulation primarily targets the production of antibodies against the specific HPV types included in the vaccine. 
• B-Cell Activation: The vaccine activates B lymphocytes (B cells), leading to antibody production. These antibodies are specific to the viral proteins present in the VLPs. 
• Antibody-Mediated Immunity: The generated antibodies circulate in the bloodstream and are poised to recognize and neutralize the corresponding HPV types if an individual is exposed to them in the future. 
• Memory Response: The immune system “memorizes” the structure of the viral proteins, enabling a more rapid and effective immune response upon subsequent exposure to the actual HPV virus. 

Spectrum of Activity: 

• The nonavalent HPV vaccine targets nine HPV types: HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58. 
• High-Risk Types: HPV types 16 and 18 are considered high-risk because they are strongly associated with the development of cervical cancer and other HPV-related cancers, such as anal, vulvar, vaginal, penile, and oropharyngeal cancers. 
• Low-Risk Types: HPV types 6 and 11 are considered low-risk and are associated with the development of genital warts and recurrent respiratory papillomatosis (RRP). 
• Additional High-Risk Types: HPV types 31, 33, 45, 52, and 58 are also associated with an increased risk of cervical and other HPV-related cancers. 

Drug Interaction

Adverse Reaction

Black Box Warning

Black box warning: 

None 

Contraindication / Caution

Contraindications/caution: 

Contraindications: 

• Severe Allergic Reaction (Anaphylaxis): Individuals who have had a severe allergic reaction (anaphylaxis) to a previous dose of the nonavalent HPV vaccine or any of its components, including yeast, should not receive further doses. 
• Immediate Hypersensitivity Reaction: Subsequent doses of the nonavalent HPV vaccine are contraindicated if an individual experiences an immediate hypersensitivity reaction (such as anaphylaxis) after a previous dose. 

Caution: 

• Moderate or Severe Acute Illness: Vaccination may be delayed in individuals with moderate or severe acute illnesses. However, a mild illness, such as a low-grade fever or upper respiratory infection, is generally not a reason to delay vaccination. 
• History of Guillain-Barré Syndrome (GBS): Individuals with a history of Guillain-Barré Syndrome (GBS) may be approached with caution. The decision to vaccinate should be made on a case-by-case basis, considering the individual’s health status and potential risks. 
• Latex Allergy: The vaccine vial stopper may contain natural rubber latex. Individuals with known latex allergies should inform their healthcare provider to determine if an alternative vaccine presentation is available. 

Pregnancy / Lactation

Pregnancy consideration: It is not recommended during pregnancy 

Lactation: Excretion of the drug in human breast milk is unknown 

Pregnancy category: 

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: There is no data available for the drug under this category 

Pharmacology

Pharmacology: 

The human papillomavirus (HPV) vaccine, nonavalent, is a vaccine designed to protect against infection with several strains of HPV, which is a group of viruses that can lead to various cancers and diseases. The nonavalent HPV vaccine targets nine HPV types, providing broader protection compared to earlier versions of the vaccine.  

The nonavalent HPV vaccine contains virus-like particles (VLPs) that resemble the outer structure of the HPV viruses but do not contain the viral DNA, making them non-infectious. 

The vaccine targets HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. 

Pharmacodynamics:  

Immune Response Stimulation: 

• The nonavalent HPV vaccine contains virus-like particles (VLPs) representing the outer shell of nine different HPV types. 
• When the vaccine is administered, the immune system recognizes these VLPs as foreign and mounts an immune response. 

Antibody Production: 

• The primary goal of the immune response is the production of specific antibodies against the HPV VLPs. 
• Antibodies are proteins that circulate in the bloodstream and can recognize and neutralize the actual HPV viruses if a person is later exposed. 

Cellular Immune Response: 

• In addition to antibody production, the vaccine can also stimulate a cellular immune response. 
• This involves the activation of T cells, which are white blood cells that can directly attack and destroy cells infected with the HPV virus. 

Memory Immune Response: 

• The immune system “memorizes” the characteristics of the HPV VLPs, creating a memory immune response. 
• If a vaccinated individual is later exposed to the corresponding HPV virus, the immune system can rapidly recognize and mount a defense, preventing or reducing the severity of infection. 

Cross-Protection: 

• The immune response generated by the nonavalent HPV vaccine may provide some cross-protection against HPV types that are closely related to those included in the vaccine. 
• This cross-protection can enhance the overall effectiveness of the vaccine. 

Pharmacokinetics: 

Absorption 

The nonavalent HPV vaccine is administered through intramuscular injection. This route of administration ensures direct delivery into the bloodstream, bypassing the need for absorption through the gastrointestinal tract. 

Distribution 

After administration, the vaccine antigens (virus-like particles) are distributed throughout the body via the bloodstream. The immune system cells, such as antigen-presenting cells (APCs), take up the antigens, initiating an immune response. 

Metabolism 

Unlike traditional drugs, vaccines like the nonavalent HPV vaccine do not undergo metabolism in the same way. The vaccine contains virus-like particles that mimic the structure of the HPV virus but does not contain live viruses or genetic material that can replicate within cells. Metabolic processes typically associated with drug metabolism, such as liver enzyme activity, are not relevant for vaccines. 

Elimination and Excretion 

Excretion is not a primary consideration for vaccines. The components of the nonavalent HPV vaccine are designed to stimulate an immune response, and they are ultimately cleared from the body as the immune response subsides. The primary goal of the vaccine is to induce an immune memory response, not to persist in the body like a drug. 

Adminstartion

Administration: 

Intramuscular administration 

• Give intramuscular (IM) to the upper arm’s deltoid region or the thigh’s higher anterolateral region. 
• After administering, observe patients for fifteen minutes. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: human papillomavirus vaccine, nonavalent 

Why do we use human papillomavirus vaccine, nonavalent? 

The human papillomavirus (HPV) vaccine, nonavalent, is used to prevent infection with certain strains of HPV. The nonavalent HPV vaccine is designed to protect against nine different types of HPV, offering broader protection compared to earlier versions of the vaccine. 

• Prevention of Cervical Cancer: One of the primary purposes of the nonavalent HPV vaccine is to prevent cervical cancer. HPV types 16 and 18, which are covered by the vaccine, are known to be high-risk types associated with the development of cervical cancer. 
• Prevention of Other HPV-Related Cancers: In addition to cervical cancer, the nonavalent vaccine protects against other HPV-related cancers, including vulvar, vaginal, and anal cancers. 
• Prevention of Genital Warts: The nonavalent HPV vaccine includes protection against HPV types 6 and 11, which are responsible for most genital warts. The vaccine helps prevent the development of these warts. 
• Reduction of HPV-Related Infections: By targeting multiple high-risk HPV types, the nonavalent vaccine aims to reduce the overall burden of HPV-related infections in both males and females. 
• Prevention of Precancerous Lesions: The nonavalent HPV vaccine helps prevent the progression of these lesions, reducing the risk of subsequent cancer development. 
• Protection for Both Males and Females: The nonavalent HPV vaccine is recommended for both males and females. In addition to preventing cervical cancer in females, it helps protect males against HPV-related cancers and diseases, including anal cancer. 
• Vaccination for Adolescents: The vaccine is often administered to adolescents, typically before they become sexually active. Vaccinating at a young age protects against potential exposure to HPV.