Bevac

Purified HBsAg.

See Table 1.

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BEVAC is a sterile suspension containing highly purified, non-infectious major surface antigen of the Hepatitis-B virus produced by recombinant DNA technology. The antigen is adsorbed onto high affinity aluminium hydroxide gel particles and hence the suspension appears almost white and translucent. BEVAC is available in paediatric dose vials (containing 10 μg HBsAg/dose) as well as adult dose vials (containing 20 μg HBsAg/dose). The vaccine meets the requirements of WHO and BP.
Recombinant technology: The hepatitis-B surface antigen (HBsAg) has been developed in genetically engineered yeast cells of Pichia pastoris which carry the gene that codes for the major surface antigen protein of the hepatitis-B virus (HBV). HBsAg expressed in yeast cells is purified by complex physical, chemical and biochemical processes. The resultant highly purified surface antigen assembles spontaneously into spherical particles of an average diameter of 20-24 nm containing non-glycosylated polypeptides in a lipid matrix. An extensive and rigorous in-house R&D processes characterized and confirmed that these 20-24 nm spherical particles resemble that natural HBsAg protein in their antigenic properties. The efficacy and safety of the formulated BEVAC is ensured through stringent adherence to the highest standards of bio-process control and consistent quality assurance measures. No substance of human origin is used in the manufacture of HBsAg protein.
Immunological Properties: In clinical trials, BEVAC induced specific antibodies in the vaccinees against hepatitis B virus. Three doses of BEVAC immunization elicited high protective humoral antibody levels in of the recipients.

BEVAC is indicated for immunization of persons exposed to infection by hepatitis B virus and its common sub-types. It can also be given to hepatitis C and D virus infected patients to protect them against co-infection with hepatitis B virus. BEVAC is recommended primarily for neonates, infants, children and adults not only for the prevention of the disease but also to protect them from probable hepatitis B virus - induced carrier state, cirrhosis and hepato-cellular carcinoma. In addition, for various groups of individuals as listed as follows, BEVAC immunization is an essential requirement: Healthcare personnel.
Patients prone to infection due to unscreened or improperly tested blood transfusions.
Hemophiliacs and patients on haemodialysis.
Travelers to specified high endemic areas.
Residents in high endemic areas.
Persons in contact with infected sexual partners.
Drug addicts.
Personnel and residents of community homes and hostels.
Household contacts of persons with acute or chronic hepatitis B virus infection.
Infants born to hepatitis B virus carrier mothers.
Organ transplant receivers.
Others: Police, Armed forces and such other regimented personnel.

Administration: The liquid vaccine vial should be shaken before use to homogenize the suspension. BEVAC should be injected deep intramuscularly into the deltoid muscle region in adults and in the antero-lateral aspect of the upper/mid thigh in neonates, infants and children. BEVAC should not be injected into the gluteal muscles. It is not recommended for intradermal administration. These routes of administration may result in lower immune response. Under no circumstances BEVAC should be given intravenously.
Dosage: As indicated in the composition an adult dose is formulated for adults and children above 10 years of age. Paediatric dose is recommended for neonates, infants and children at and below 10 years of age.
Immunization Schedule: See Tables 2, 3 and 4.

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In order to prevent HBV transmission from mother to infant, the first dose of hepatitis B vaccine needs to be given as soon as possible after birth (preferably within 24 hours). This must be followed by a second and third dose at the time of the first and third diphtheria-tetanus-pertussis (DTP) vaccination.
Temporary immunity may be obtained using hepatitis B immune globulin (HBIG) for post-exposure prophylaxis. As a rule, HBIG should be used as an adjunct to hepatitis B vaccine when given at birth, but at a different injection site. However, in full-term newborns, the protection against perinatally acquired infection achieved by immediate (<24 hours) hepatitis B vaccination is not significantly improved by the addition of HBIG.

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Alternatively for preterm infants, to prevent perinatal transmission, a four-dose schedule may be used; if the birth weight is <2000 grams, the vaccine dose at birth should not be counted towards the primary series, and three additional doses should be given. These doses may be given either as monovalent vaccine or as a combination (e.g. with DTP and/or Hib) following the schedules commonly used for DTP vaccines. These schedules will prevent most perinatally acquired infection.

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Booster Doses: In immunocompetent individuals hepatitis B vaccine induces an effective immunological memory that lasts life-long and protects against symptomatic acute illness and development of chronic infection on exposure to the virus. Boosters of hepatitis B vaccine are, therefore, not necessary under usual circumstances.
Catch-up Vaccination: Catch-up vaccination with hepatitis B vaccine of older age groups, including adolescents and adults should be considered only if the continuity of the infant vaccination programme can be ensured. If a higher proportion of chronic infections may be acquired among older children, adolescents and adults; catch-up immunization for these groups may be considered.
Schedule for older children and adults: For older children and adults the preferred schedule is 0, 1 and 6 months, 0 being the elected date for first dose.
Immunization in special situations: Immunocompromised Individuals: It is recommended (by Advisory Committee on Immunization Practices-ACIP) that adults with HIV infection receive hepatitis B vaccination (3 doses). Immunosuppressive illnesses such as advanced HIV infection, chronic liver disease, chronic renal failure and diabetes are associated with reduced immunogenicity of the vaccine.
Unresponsive Individuals: Persons unresponsive to the primary series of hepatitis B (serum anti-HBsAg concentration less than 10 mlU/L), may require revaccination of a fourth or fifth dose, or a new complete course of immunization at the discretion of the medical practitioner.

BEVAC is generally well tolerated. However the vaccine should not be administered or repeated to persons known to be hypersensitive to any of the components of the vaccine. Avoid immunization during severe febrile illness.

It is suggested that the medical practitioners ascertain the pre-immunization hypersensitivity status of the subject. In general, biologicals are known to cause reactions occasionally. Sympathomimetic drug like adrenalin may be kept readily available in case of rare anaphylactic reactions due to the vaccine. While using the multi-dose vial, care must be taken to use separate sterile syringe and needle for the administration of every dose.
Before use, BEVAC should be well shaken to obtain a uniform, whitish translucent suspension. Vaccine should be visually checked for the presence of any particulate matter or other coloration, if any, prior to its administration. If in doubt, do not use the contents of the vial.
NOTE: Because of the long incubation for hepatitis-B virus to manifest the symptoms, some subjects may receive the vaccine while the infection stays unrecognized. In such cases, the vaccine may not prevent the onset of hepatitis due to hepatitis-B virus. BEVAC will not prevent hepatitis caused by other viruses such as hepatitis A, hepatitis C and hepatitis D and other agents known to infect the liver.

Routine vaccination of pregnant women with recombinant hepatitis-B vaccine is not recommended due to inadequate data on its effects on the foetus. No contraindication was recorded for the use of the vaccine in lactating mothers. However the decision to immunize pregnant and lactating mothers may be taken by the physician in the context of case-specific high risk factors.

BEVAC has proven for low reactogenicity and is well tolerated. Open and comparative trials did not show adverse reactions in the vaccinees. Soreness at the site of injection or a febrile reaction may be observed in some subjects. In rare cases of post vaccinal hypersensitivity, the common symptoms that are quickly recognized by the physician are: dizziness, headache, nausea, abdominal pain, rash, pruritus, urticaria, arthralgia, myalgias and similar associated symptoms and side effects.

Interactions with other vaccines and other forms of interactions: Hepatitis B vaccine can be administered safely and effectively at the same time as BCG, DTP, measles, polio (OPV or IPV), Haemophilus influenzae type b, or yellow fever vaccines that are extensively used in the Expanded Programme on Immunization (EPI), worldwide or vitamin A supplementation. If hepatitis B vaccine is given at the same time as other vaccines, it should be administered at a separate site. It should not be mixed in the vial or syringe with any other vaccine unless it is licensed for use as a combined product (e.g. DTP Hep B/DTP Hep B-Hib).

Handling of multi dose vial: Once opened, multi dose vials of BEVAC from which one or more doses of vaccine have been removed during an immunization session may be used in subsequent immunization sessions for up to a maximum of 4 weeks, provided that all of the following conditions are met: The expiry date has not passed.
The vaccines are stored under appropriate cold chain conditions.
The vaccine vial septum has not been submerged in water.
Aseptic technique has been used to withdraw all doses.
The vaccine vial monitor (VVM) has not reached the discard point.
Vaccine Vial Monitor (VVM) is part of the label. The colour dot appears on the label of the vial, is a VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has been exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central square. Its colour will change progressively. As long as the colour of this square is lighter than the colour of the ring, then the vaccine can be used. As soon as the colour of the central square is the same colour as the ring or of a darker colour than the ring, then the vial should be discarded.

Store between 2°C to 8°C. Do not freeze. Discard if the vaccine has been frozen.
Shake well before use.
Safety, Stability and Potency: BEVAC contains highly purified HBsAg in a formulation that consistently conforms to pharmacopoeial standards. Experimental data, both at the production and R&D laboratories, have shown the formulation to be stable and potent for 36 months at 2°C to 8°C.
Shelf Life: 3 years from the date of manufacture.

Vaccines, Antisera & Immunologicals

J07BC01 - hepatitis B, purified antigen ; Belongs to the class of hepatitis viral vaccines.

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