Elovac-B is a non-infectious recombinant DNA vaccine. It is a sterile, slightly white turbid suspension of purified major surface antigen of HBV. The HBsAg is produced from cultures of genetically engineered Pichia pastoris, containing the gene that codes for the HBsAg. The HBsAg protein released by disruption of Pichia pastoris cells is purified by various physiochemical methods. The purified antigen is adsorbed onto aluminium hydroxide gel to prepare bulk vaccine. The vaccine dose does not contain any material of human or animal origin.
Indications: Elovac-B vaccine is indicated for immunization against infection caused by all know subtypes of Hepatitis-B virus (HBV).
Dose administration: Paediatric & Adolescent dose: Each 0.5ml dose contains 10mcg of Hepatitis B surface antigen (purified) adsorbed on 0.25mg Aluminium as Aluminium hydroxide and 0.025mg of Thiomersal as preservative.
Adult dose: Each 1 ml adult dose contains 20 mcg of Hepatitis B surface antigen (purified) adsorbed on 0.5 mg Aluminium as Aluminium hydroxide and 0.05mg of Thiomersal as preservative.
The following are the common side effects of elovac-B:
Mild pain, soreness, indurations and erythema at the site of injection
Rare and undesirable side effects caused by elovac-B are the following:
- Systemic: Fatigue, low-grade fever and malaise.
- Skin and appendages: Rash, pruritus and urticaria.
- Musculoskeletal system: Arthralgia and myalgia.
- Digestive system: Nausea, vomiting, diarrhoea and abdominal pain.
- Hepatobiliary system: Abnormal liver function tests.
- Nervous system: Dizziness and paresthesia.
Very rare and undesirable side effects caused by elovac-B are the following:
- Systemic: Anaphylaxis, serum sickness, angioedema and erythema multiforme.
- Musculoskeletal system: Arthritis.
- CVS: Syncope and hypotension.
- Nervous system: Neuropathy, neuritis (including Guillain-Barre' syndrome, opticneuritis), encephalitis and meningitis.
- Respiratory system: Bronchoconstriction like symptoms.
- Lymphoid system: Lymphadenopathy
- Caution and care should be exercised in administering the vaccine to individuals with severe compromised cardiopulmonary status as systemic reaction could pose a significant risk.
- As with any injectable vaccine, epinephrine and an antihistamine for injection should be available for use in case of anaphylaxis or anaphylactic reaction. Other supportive care for the management of such an emergency should be available nearby.
- The vaccine should be gently shaken well before use. Precautions should be taken while administering the Elovac-B vaccine by intramuscular route to people with known/suspected disorder of bleeding.
- In presence of minor infection Elovac-B to be used only when clearly needed and the possible advantage outweighs the possible risks.
- A hypersensitivity reaction to any component of any hepatitis B recombinant DNA vaccine.
- Severe febrile illness.