Cervarix: Inactivated HPV Vaccine
Cevarix 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 bi-valent human papillomavirus vaccine.
1 dose 0.5 ml) contains Human Papillomavirus type 16 L1 protein 20 micrograms, Human Papillomavirus type 18 L1 protein 20 micrograms, 3-0-desacy-4- monophosphoryl lipid A (MPL)2 50 micrograms, Aluminium hydroxide, hydrated
0.5 milligrams A3. Cell substrate Hi-5 Rox4446 cells.
L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system. The GlaxoSmithKline proprietary AS04 adjuvant system is composed of aluminium hydroxide and 3–desacyl-4 monophosphoryl lipid A (MPL).
|Human Papillomavirus type 16 L1 protein|
Human papillomavirus type 18 L1 protein
|Aluminium hydroxide hydrated||0.5 mg|
How is Cervarix HPV vaccine available?
Cevarix HPV vaccine is available in ready to inject formulation as slightly opalascent liquid form.
It is available in pre-filled sterile syringe for injection.
The dose is available 0.5 ml. It is available in single dose packet.
How is Cervarix vaccine stored?
Cervarix 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.
Cervarix 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 Cervarix HPV vaccine given?
Cervarix HPV vaccine is given by injection on anterolateral aspect of thigh. 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 Cervarix vaccine is given?
- CERVARIX 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 CERVARIX 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.
- Cervarix vaccine is not to be used during pregnancy or in woman who are trying to become pregnant.
- Cervarix vaccine is not be used in lactating women.
|Age at the time of the first injection||Immunization schedule|
|9 to and including 14 years||Two doses each 0.5 ml. The second dose given between 5-13 months after first dose|
|From 15 years and above||Three doses each of 0.5 ml at 0, 1, 6 months of age|
Safety with other vaccines:
- Cervarix vaccine may be administered with a combined booster vaccine containing diphtheria, tetanus, pertussis acellular with or without inactivated poliomyelitis.
- Cervarix 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 Cervarix vaccine works?
Cervarix 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 Cervarix HPV vaccine is active form of immunization which induces immune response in host against virus it is intended for.
Cervarix is for prophylactic use only and has no effect on active HPV infections or established clinical disease. Cervarix 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 Cervarix 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 is seen in some patients after vaccination can be managed at home with oral rehydrating solution and subsides by its own.
- Loss of appetite and vomiting is usually mild and usually subsides by its own.
- Itching, pruritus, rash and urticaria may occur which may mimic allergy like symptoms.
- Muscular pain and fatigue seen after Cervarix 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.
To whom this vaccine should not be given?
Cevarix Hpv vaccine has few contraindications:
- Those who are known to be allergic to any of its components should not get this vaccines.
- Do not give this vaccine to patient who had got anaphylactic reaction ayt the time of the previous dose.
- Safety of this vaccine in pregnancy and lactation is not known.
Warnings and precautions with this vaccine
Some precautions should be taken while giving this vaccine:
- This vaccine is for prevention of HPV infection not for the treatment purpose. Counsel patients that this vaccine is not for the treatment purpose.
- This vaccine will not prevent the infection and disease if patient is already infected with the virus.
- This vaccine protects against only the strain it contains and some other strains by cross reactivity but not all strains.
- Even after this vaccine pap smear screening is needed as suggested by gynecologists. The vaccine is not the replacement for the screening.
- Like all the vaccines this vaccine may cause anaphylaxis extremely rarely in some patients and center at which vaccination is done should be equipped with medicines and skills to manage the anaphylactic reaction.