Key points
- Hepatitis A is a highly contagious liver infection caused by the hepatitis A virus.
- There are vaccines than can protect against hepatitis A.
Overview
Hepatitis A infection can range from a mild illness lasting a few weeks to a severe illness lasting several months. Although rare, hepatitis A can cause death in some people.
Available vaccines & manufacturer package inserts
Single antigen vaccines and manufacturer inserts
Contains only hepatitis A vaccine.
- The FDA approved Havrix in 1995. It is approved for people 1 year of age and older, travelers to other countries, and others at risk.
- FDA approved Vaqta in 1996. It is approved for people 1 year of age and older, travelers to other countries, and others at risk.
Combination vaccine and manufacturer insert
Contains hepatitis A vaccine and hepatitis B vaccine, combined into a single dose.
- FDA approved Twinrix in 2001 for protection against hepatitis A and hepatitis B disease. It is approved for people 18 years of age and older, travelers to other countries, and others at risk.
Who should & should not get the vaccine
- All children, beginning at 1 year.
- People with unstable housing or experiencing homelessness.
- People who are at increased risk for infection.
- People who are at increased risk for complications from hepatitis A.
- Anyone who wants protection against hepatitis A.
Common side effects
- Swelling, tenderness, redness, warmth, or a hard lump where the shot was given.
- Low fever.
- General ill feeling.
- Nausea.
- Loss of appetite.
- Headache.
When to call 911
Hepatitis A vaccines are safe and effective at preventing hepatitis A infections. Vaccines, like any medicine, can have side effects. The common side effects are usually mild and last 1-2 days.
Report possible adverse events to VAERS
A closer look at the safety data
Findings from vaccine safety monitoring systems and scientific studies have shown that hepatitis A vaccines have a favorable safety profile—the body of scientific evidence overwhelmingly supports their safety.
- Since hepatitis A vaccine was licensed in 1995 through 2005, approximately 50 million doses were distributed in the United States. In that same time, VAERS received 6,136 reports of adverse events among people who received the hepatitis A vaccine (by itself or with other vaccines). The most common events reported were fever, injection site reaction, rash, and headache. The review of these reports was unable to determine a causal relationship between the vaccine and the reported events. The review of VAERS reports were similar to the original safety review for Havrix and Vaqta. During prelicensure clinical trials, the most commonly reported side effects for Havrix and Vaqta in both adults and children included injection site reactions, such as soreness, tenderness, pain, warmth, and headache. Children 11-25 months who received Havrix were also reported to experience irritability, drowsiness, and loss of appetite.1
- A 2004 study of Vaqta among a large group of California patients showed no health problems linked to vaccination. More than 49,000 doses of Hepatitis A vaccine were given to the patients; 15,000 were given to children younger than 18 years of age.2
- A 2-year review of Hepatitis A vaccine safety using VAERS data found no safety problems when the vaccine began to be used as part of the routine immunization schedule in the United States.3
How CDC monitors vaccine safety
CDC and the Food and Drug Administration (FDA) are committed to ensuring that vaccines provided to the public are safe and effective. Once vaccines are licensed or authorized for emergency use in the United States, CDC and FDA continuously monitor them through several safety systems.
Resources
- https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5507a1.htm
- Black, S., Shinefield, H., Hansen, J., Lewis, E., Su, L., & Coplan, P. (2004). A post-licensure evaluation of the safety of inactivated hepatitis A vaccine (VAQTA, Merck) in children and adults. Vaccine, 22(5-6), 766–772. https://doi.org/10.1016/j.vaccine.2003.08.034
- Niu, M. T., Salive, M., Krueger, C., & Ellenberg, S. S. (1998). Two-year review of hepatitis A vaccine safety: data from the Vaccine Adverse Event Reporting System (VAERS). Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 26(6), 1475–1476. https://doi.org/10.1086/517673
- Niu MT, Salive M, Kruger C, Ellenberg SS. Two-year review of hepatitis A vaccine safety: Data from the Vaccine Adverse Event Reporting System (VAERS). Clin Infect Dis. 1998 Jun;26(6):1475-6.
- Black S, Shinefield H, Hansen J, Lewis E, Su L, Coplan P. A post-licensure evaluation of the safety of inactivated hepatitis A vaccine (VAQTA, Merck) in children and adults. Vaccine. 2004 Jan 26;22(5-6):766-72.
- Woo EJ, Miller NB, Ball R, VAERS Working Group. Adverse events after hepatitis A B combination vaccine. Vaccine. 2006 Mar 24;24(14):2685-91.
- Fiore AE, Wasley A, Bell BP. Prevention of Hepatitis A Through Active or Passive Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP).MMWR Recomm and Reps. 2006 May 16;55(RR07):1-23.
- Karali Z, Basaranoglu ST, Karali Y, Oral B, Kilic SS. Autoimmunity and hepatitis A vaccine in children. J Investig Allergol Clin Immuno. 2011;21(5):389-93.
- Moro PL, Museru O, Niu M, Lewis P, Broder K. Reports to the Vaccine Adverse Event Reporting System After Hepatitis A and Hepatitis AB Vaccines in Pregnant Women.Am J, Obstet Gynecol. 2014 Jun;210(6): 561.e1-6.