Recombivax HB: Inactivated Hepatitis B vaccine
Recombivax HB vaccine is used to prevent the Hepatitis B disease. It is vaccine by Merck. It is inactivated Hepatitis B vaccine.
This vaccine is available in adult and pediatric dosages. Pediatric dosage 0.5 ml contains Hepatitis B virus surface antigen HBsAg. Adult dose is 1 ml contains Hepatitis B virus surface antigen.
How is Recombivax HB vaccine available?
Recombivax HB vaccine is available as injection liquid form. It is available as 0.5 ml dose or 1 ml dose. It is available as pre filled syringe without needle. It is available in single dose form. It is packed in opaque box to protect from sunlight.
Pediatric/Adolescent Formulation (Without Preservative), 10 mcg/mL: each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen.
Adult Formulation (Without Preservative), 10 mcg/mL: each 1 mL dose contains 10 mcg of hepatitis B surface antigen.
Dialysis Formulation (Without Preservative), 40 mcg/mL: each 1 mL dose contains 40 mcg ofhepatitis B surface antigen
How is Recombivax HB vaccine stored?
Recombivax HB vaccine is stored at 2-8 degree Celsius. The temperature range should be maintained with the help of cold chain. The temperature range should be maintained at all levels of transport and storage. The vaccine should not be frozen. If the vaccine is frozen accidentally it should be discarded and not used for the injection.
How is Recombivax HB vaccine given?
Recombivax HB vaccine is given as injection on the antero lateral aspect of thigh in children with needle as intramuscular route. All the safe injection precautions should be followed while giving injection. The disposables should be discarded as per biomedical waste management protocols. The vaccine that has passed expiry should be discarded as per biomedical waste management protocol rules. For those above 19 years 1 ml dose is given. For those below 18 years 0.5 ml dose is needed.
For those who have bleeding disorder this vaccine can be administered subcutaneously and firm pressure is given after the vaccination. The vaccination should be preferably planned after getting the dose of clotting factor in haemophilliacs.
At what age Recombivax HB vaccine is given?
· Recombivax HB vaccine is given in routine immunization at Birth and then at 6 weeks 10 and 14 weeks of age.
· If not given in routine immunization it is given at schedule 0, then second dose at 1 month and then third dose at 6 months of first dose.
· The dosing schedule is same for both infants of HBsAg positive and negative mothers.
· Till age 19 dose is 0.5 ml and above that age dose for adult is 1 ml each dose.
· Primary immunization for patients on hemodialysis consists of a series of 3 doses (1 mL each) given as 0, 1, 6 months schedule.
· Persons with known or presumed exposure to the hepatitis B virus (e.g., neonates born of infected mothers HBsAg positive, persons who experienced percutaneous or permucosal exposure to the virus) should be given hepatitis B immune globulin (HBIG) in addition to Recombivax HB vaccine.
|Infants born of:|
HBsAg negative mothers
HBsAg positive mothers
|Infants, Children, adolescents:|
Birth through 19 years of age
( 5 mcg) 0.5 ml
11 through 19 years of age
(10 mcg) 1 ml
20 years of age and older
(10 mcg) 1 ml
|Adults on haemodialysis|
|(40 mcg) 1 ml||0,1,6 months|
How does Recombivax HB vaccine works?
This vaccine is active form of immunization but it is inactivated vaccine. Recombivax HB vaccine contains HBs-antigen of Hepatitis B virus in inactivated form. This antigen is obtained by the recombinant technology. When this vaccine is injected to a host the immunity of the host recognizes the antigen on Hepatitis B virus. The immunity is form against this virus and in the process the memory is also formed. When the real infection occurs the immune response is boosted against the infection and protects the person against the disease itself.
Safety with other vaccine:
Recombivax HB vaccine is safe with most other medicine and no drug interactions were noted. The other vaccine or other drug should not be mixed in same syringe as this vaccine.
Like other inactivated vaccines Recombivax HB vaccine is considered as safe in pregnant and lactating woman, but the risk benefit ratio should be evaluated by the caregiver.
Concomitant administration of typhoid, tetanus and yellow fever vaccine is safe with this vaccine.
Concomitant administration of Recombivax HB and anti hepatitis B immunoglobulin does not alter the protective effect of Recombivax HB vaccine.
What are side effects of Recombivax HB vaccine?
This vaccine causes side effect that are generally milder and can be managed at home and does not need hospital admission:
· Fever is common side effect after the vaccination. It usually subsides in 1-3 days and can be managed very easily at home with medicine like paracetamol and sponging.
· Swelling and pain occurs at injection site may last for 1-3 days can be managed with paracetamol and local cold compression.
· Diarhea and loss of appetite can occur after vaccination and can be managed by oral rehydrating solution.
· Nausea and vomiting may occur after the vaccination and it can be managed by oral syp ondansetron and oral rehydrating solution.
· Abdominal pain.
· Muscular pain and joint pain.
· Headache and fatigue.
· Anaphylaxis and allergy is extremely rare side effect of the vaccine. Like other vaccines the vaccine should be administered at center where necessary personnel and drugs and equipments are available to manage if any reaction occurs.