Havrix Hepatitis A Vaccine

Havrix inactivated vaccine is a sterile suspension of inactivated virus strain HM175, propagated in MRC-5 human diploid cells. The cells are lysed after removing the cell culture medium 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, BL 103475/5740 updated October 27, 2023.

Anyone not vaccinated or previously infected can get infected with the hepatitis A virus. The WHO estimates that in 2016, 7,134 persons died from hepatitis A worldwide.

Learn more about GlaxoSmithKline Biologicals (GSK) hepatitis vaccines. 

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 vaccination should be administered at least two weeks before exposure to HAV. Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine or any component of HAVRIX, including neomycin, is a contraindication to administering HAVRIX.

Havrix Hepatitis A Vaccine Immunocompromised

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to HAVRIX. Vaccination with HAVRIX may not protect 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 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 two weeks before exposure to HAV.

Havrix Hepatitis A Vaccine Adverse Reactions

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. In clinical trials with HAVRIX in adults and children two 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.