Heplisav B vaccine is obtained by recombinant technology. HBsAg antigen is purified and used in this vaccine.
The HBsAg is expressed in a recombinant strain of Hansenula polymorpha yeast. The fermentation process involves growth of the recombinant H. polymorpha on chemically-defined fermentation media containing vitamins and mineral salts.
This HBsAg is later purified and then incorporated into the vaccine.
Each 0.5-mL dose is formulated to contain 20 mcg of HBsAg and 3000 mcg of CpG 1018 adjuvant.
This vaccine does not contain preservatives.
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How is the Heplisav B vaccine available?
Heplisav B is available as a pre-filled syringe 0.5 ml dose each.
It is available as a single dose syringe packet or as 5 syringes packet.
It is kept in a carton to protect it from sunlight.
At what age to get the Heplisav B vaccine?
Heplisav B is a purified antigen vaccine for prevention of Hepatitis B disease
Give this vaccine given for age above 18 years.
How to give the Heplisav B vaccine?
This vaccine is given by an intramuscular route.
It is given by injection on shoulder and deltoid muscle.
All the safety injection precautions should be followed while injecting this vaccine.
Disposable items used should be discarded as per local biomedical waste management protocols to protect your environment.
Dose of vaccine
For age more than 18 years the dose is 0.5 ml. The second dose is given after at least 1 month.
This is unlike other Hepatitis B vaccines where a dose of 1 ml or more is needed above age 18 and 3 doses are needed.
Only 2 doses of 0.5 ml at least 1 month apart are needed with this vaccine.
Correct technique of Heplisav B vaccine administration
Heplisav B vaccine is needed to be administered intramuscular.
Skin is cleaned with normal spirit solution at the injection site.
The dose vaccine is given using 23-24no needles for intramuscular injection.
The needle is inserted intramuscular to the skin.
The vaccine is injected slowly while removing the needle from the injection site slowly.
How to store Heplisav B vaccine?
Store Heplisav B vaccine as per recommendations of supplier or manufacturer.
Store this vaccine at temperature 2-8 degree Celsius.
It shouldn’t be frozen.
Maintain the temperature range using a strict cold chain.
Maintain the cold chain all all stages from manufacturer to the end user.
If the temperature recommendations were not followed, discard the vaccine.
While discarding local biomedical waste management protocols should be followed to protect environmental damage.
How Does the Heplisav B Vaccine work?
Heplisav B is a purified antigen vaccine.
When it is injected, the purified antigen in it enters you. It cannot cause you the disease Hepatitis B.
Your immunity recognizes this HBsAg antigen and develops an immune mechanism against it.
So when real infection occurs this developed immune system can fight back effectively.
Thus we can prevent Hepatitis B disease from occurring.
This vaccine cannot treat Hepatitis B but it is used for prevention.
Safety of vaccine with other vaccines:
The concomitant use of immunoglobulin and Heplisav B vaccine is not available yet for post exposure prophylaxis.
When used with immunoglobulin it should be injected at different sites with different syringes.
What are the side effects of the Heplisav B vaccine?
With this vaccine following are common side effects. These all side effects though occur generally are mild and can be managed at home and do not usually need admission. They usually occur in the first 5 days after vaccination.
- Pain, swelling, redness: Injection site pain, swelling and redness can occur within a few hours of giving this vaccine. It can be reduced with cold compression and medicine like paracetamol in adequate doses.
- Fever: Fever may occur within a few hours of giving this vaccine. It can be managed with or without medicines as needed symptomatically.
- Muscle pain: Limb pain muscle pain and fatigue are known side effects after vaccination. It usually subsides on its own. The intensity of side effects can be decreased with paracetamol.
- Headache: Headache may occur after vaccination usually mild to moderate grade and subsides in some days. It can be managed with oral medication like paracetamol.
- Anaphylaxis: Like all other vaccines and drugs this vaccine may cause anaphylaxis and severe allergic reactions. They are extremely rare to occur.
- Malaise: Malaise and feeling of fatigue after vaccination can come and may subside in a few days.
To whom Heplisav B Vaccine should not be given?
In following cases this vaccine should not be given:
- Do not give this vaccine if the patient is known to be allergic to any of its components.
- Do not give this vaccine if the patient had got an allergic or anaphylactic reaction at the time of the previous dose.
- In pregnancy and breastfeeding mothers yet there is no sufficient data in this group. It is considered as safe in pregnancy.
- This vaccine is yet not approved for use in less than 18 years old.
- The safety of this vaccine in patients on haemodialysis has not been established yet.
- Safety above age 70 years has not been yet examined but extrapolated data from those below age 65 years age suggests it is safe ingeriatric age group.
Warnings and caution
- This vaccine prevents Hepatitis B but does not treat it.
- This vaccine may not protect all those who have received vaccination.
- Need of additional doses and booster is not yet known.
- Like any other vaccine, give this vaccine with readiness to manage anaphylaxis reaction.
- This vaccine will not protect the individual if given in stages when person is infected but yet not detectable by the tests.