HPvax is a vaccine indicated for the prevention of the following diseases
caused by oncogenic Human Papillomavirus (HPV) types 16 and 18:
• Cervical cancer
• Cervical intraepithelial neoplasia (CIN) Grade 2 or worse and adenocarcinoma in situ
• Cervical intraepithelial neoplasia (CIN) Grade 1
Dosage & Administration
|Age at the time of the first injection||Immunization and schedule|
|9 to and including 14 years||2 doses|
|2nd dose 6 months after 1st dose or|
|3 doses at 0,1 and 6 months|
|From 15 years and above||3 doses at 0,1 and 6 months|
The need for a booster dose has not been established. If flexibility in the
vaccination schedule is necessary, the second dose can be injected
within 1-2 months after the first dose, and 3rd dose can be injected within
5-8 months after the first dose.
Method of Administration
HPvax should be given intramuscularly in the deltoid region of arm in
female aged from 9 years. The vaccine should be well shaken before
use. The suspension should be used as supplied, no dilution or reconstitution
process is needed. Once the vial is opened, the preparation must
be used immediately.
• Because vaccines may develop syncope, sometimes resulting in
falling with injury, observation for 15 minutes after administration is
recommended. Syncope, sometimes associated with tonic-clonic movements
and other seizure-like activity.
• HPvax will only protect against disease that are caused by HPV type
16, 18 and to some extent against diseases caused by certain other
oncogenic related HPV types. Therefore, appropriate precautions
against sexually transmitted diseases should continue to be used.
• HPvax is for prophylactic use only and has no effect on active HPV
infections. Therefore, the vaccine is not indicated for treatment of
cervical cancer or cervical neoplasia (CIN). It is also not intended to
prevent progression of other established HPV related lesions or existing
infections with vaccine or non-vaccine types.
Pregnancy Category B, reproduction studies have been performed in rats
at a dose approximately 47 times the human dose (on mg/kg basis) and
revealed no evidence of impaired fertility or harm to the fetus due HPV
vaccine. There are, however, no adequate and well-controlled studies in
pregnant women. Because animal reproduction studies are not always
predictive of human response, this vaccine should be used during
pregnancy only if clearly needed.
The effect on breast-fed infants of the administration of HPV vaccine to
their mothers has not been evaluated in clinical studies. HPV vaccine
should only be used during breast-feeding when the possible advantages
outweigh the possible risks.