Havrix Hepatitis A Vaccine Description
Havrix inactivated vaccine is a sterile suspension of inactivated virus strain HM175, propagated in MRC-5 human diploid cells. After removing the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation.
Initial U.S. Approval: 1995; Proper Name: Hepatitis A Vaccine, Inactivated: STN: BL 103475
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Havrix Hepatitis A Vaccine Indication
HAVRIX is a vaccine for active immunization against disease caused by the hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks before expected exposure to HAV.
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine or to any component of HAVRIX, including neomycin, is a contraindication to the administration of HAVRIX.
Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to HAVRIX. And vaccination with HAVRIX may not result in protection in all vaccine recipients, says GSK.
Havrix Hepatitis A Vaccine Dosage
Havrix is administered by intramuscular injection. Children and adolescents: A single 0.5-mL dose and a 0.5-mL booster dose were administered between 6 to 12 months later. Adults: A single 1-mL dose and a 1-mL booster dose administered between 6 to 12 months later. Primary immunization should be administered at least 2 weeks before expected exposure to HAV.
In clinical trials with HAVRIX in children 11 to 25 months of age, the most common solicited adverse reactions were injection-site pain and redness, irritability, drowsiness, and appetite loss. And In clinical trials with HAVRIX in adults and children 2 years of age and older, the most common solicited adverse reactions were injection-site soreness and headache.
Havrix Hepatitis A Vaccine News
December 19, 2018 - The U.S. FDA approved the request dated June 19, 2018, to supplement your Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act (42 U.S.C. 262) for Hepatitis A Vaccine, Inactivated (Havrix®), manufactured at your Belgium facility to update Section 8 of the package insert to comply with 21 CFR 201.57(c)(9)(i)-(iii) to address the Pregnancy, Lactation, and Labeling Rule.