Gardasil: Inactivated HPV vaccine

Gardasil Vaccine: Quadrivalent HPV vaccine

Gardasil vaccine protects from human papillomavirus, the most common cause of cervical cancers and benign cervical and genital lesions in human population. It is inactivated vaccine consisting of antigen proteins from the virus obtained by rDNA technology.  This is quadri-valent human papillomavirus vaccine.

1 dose 0.5 ml) contains Human Papillomavirus type 6, 11, 16, 18 antigens. It is marketed by Merck vaccines.

How is Gardasil vaccine available?

Gardasil vaccine is available in ready to inject formulation as slightly opalascent liquid form. It is available in pre-filled sterile syringe for injection. It is available 0.5 ml. It is available in single dose packet.

 How is Gardasil vaccine stored?

Gardasil vaccine is stored at 2-8 degree Celsius as recommended by manufacturer. Temperature range is maintained by the cold chain. The vaccine if accidentally frozen should be discarded and not used. The temperature range is maintained at all stages of storage and transport.

The shelf life of vaccine store properly is 48 months, the expiry date of this vaccine is indicated on label of the vaccine. Gardasil vaccine should be administered as soon as possible after removed from refrigerator. 

The stability of the vaccine has been demonstrated when stored outside refrigerator up to 3 days at temperatures between 8 degree Celsius and 25 degree Celsius or up to a day at temperature 25 to 37 degree Celsius. If not used at the end of this period vaccine should be discarded.

 How is Gardasil vaccine given?

Gardasil vaccine is given by injection on anterolateral aspect of thig. Those for adult and adolescents it can be given on deltoid region of the shoulder. This vaccine should be given by intramuscular route. This vaccine should not be given by intravascular or intradermal route as safety and efficacy of such route is unknown. All standard safe injection precautions need to be taken. After use the disposables and needles are to be discarded as per the guidelines for biomedical waste management protocols. The expired vaccine should be discarded as per BMW protocols so that it is not harmful to environment. The dose is 0.5 ml.

 At what age Gardasil vaccine is given?

  • Gardasil vaccine is indicated in females from 9 to 45 years of age for the  prevention of cervical cancer by protecting against incident and  persistent infections, cytological abnormalities including atypical  squamous cells of undetermined significance (ASC-US) and cervical  intraepithelial neoplasia (CIN), CIN 1 and pre-cancerous lesions (CN 2 and   CIN 3) caused by human papillomavirus types 16 and 18 The use of Gardasil vaccine  should be in accordance with official recommendations.
  • This vaccine is not indicated in children below age of 9 years as safety  and efficacy of this vaccine yet not been proven in such age group. 
  • Gardasil vaccine is not to be used during pregnancy or in woman who are trying to become pregnant.
  •  Gardasil vaccine is not be used in lactating women.

Safety with other vaccines:

  •  Gardasil vaccine may be administered with a combined booster vaccine  containing diphtheriatetanuspertussis acellular with or without inactivated poliomyelitis.
  • Gardasil vaccine may be administered with Hepatitis A inactivated or Hepatitis B vaccine.
  • The vaccines when given together should not be mixed in same syringe and given by different syringe at different sites by indicated route of administration.

How does Gardasil vaccine works?

Gardasil vaccine is inativated vaccine. It contains antigens of virus obtained from rDNA technology. This is active form of immunization. When this vaccine is injected to an individual the antigens in it get inside the body. These antigens are recognized by the immune system of the individuals. The immune system develops mechanism to fight against the virus and if real infection takes place the immune response is rapidly ramped up and the disease is prevented. Thus Gardasil vaccine is active form of immunization which induces immune response in host against virus it is intended for.

Gardasil vaccine is for prophylactic use only and has no effect on active HPV infections or established clinical disease. Gardasil vaccine has not been shown to have a therapeutic effect. The vaccine is therefore not indicated for treatment of cervical cancer or cervical intraepithelial neoplasia (CIN). It is also not intended to prevent progression of other established HPV-related lesions or existing HPV infections with vaccine or non-vaccine types.

What are side effects of Gardasil vaccine?

Side effects of Cervarix vaccine are usually mild and can be managed at home very easily.

  • Fever can be there after the vaccination. It can be mild to moderate grade and can be managed at home by paracetamol and sponging. Fever may last for 1-3 days usually reduces with time.
  • Local pain and redness swelling can come at injection site. It may last  for 1-3 days. It can be easily managed with paracetamol and local cold fomentation.
  • Headache and dizziness can come in some patients after vaccination. Usually reduces in 1-3 days. This headache can be managed at home with paracetamol.
  • Diarrhea and abdominal pain cab be managed at home with oral rehydration solution and usually subsides by its own.
  • Loss of appetite and vomiting.
  • Itching, pruritus, rash and urticaria.
  • Muscular pain and fatigue seen after this vaccination may last for the 1-3 days. It generally reduces by its own.
  • Allergy and anaphylactic reaction: This is very rare side effect. The vaccine should not be given to those who are allergic to the component/s of the vaccine. The anaphylactic reaction should be managed very swiftly. The skilled person, necessary drugs and equipments should be available for the management.

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