Hepatitis A Vaccine Safety

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.
Keep Reading: Vaccine Information Statement

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.
Keep Reading: Hepatitis A Vaccine

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

Severe allergic reactions following vaccination are rare, but can be life threatening. If someone experiences symptoms of a severe allergic reaction, which can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness.

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

The Vaccine Adverse Event Reporting System (VAERS) is an early warning system, co-managed by CDC and FDA, that monitors for potential vaccine safety problems. Healthcare providers and vaccine manufacturers are required by law to report certain adverse events (any side effect or health problem after vaccination that is concerning to you, even if you are not sure if the vaccine caused the event) following vaccination to VAERS; patients and caregivers can also submit reports.

Submitting a Vaccine Adverse Event Reporting System (VAERS) Report and Using VAERS Data

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 FDA are committed to monitoring the safety of vaccines. Once vaccines are licensed or authorized by FDA for use in the United States, CDC, FDA, and other federal agencies work together to monitor them using several safety systems.

Keep Reading: About CDC's Vaccine Safety Monitoring Program

Resources

Hepatitis A Basics
Who Should NOT Get Vaccinated with these Vaccines?
Who should NOT Get Vaccinated?
Hepatitis A ACIP Vaccine Recommendations
ACIP Recommendations on Hepatitis A and other MMWR articles. Advisory Committee on Immunization Prac...
Clinical Overview of Hepatitis A
Contraindications and Precautions
Contraindications and Precautions: General Best Practice Guidelines for Immunization. Advisory Commi...
Immunization Schedules
Stay up-to-date on getting recommended vaccines. Here are immunization schedules for people of all a...
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Content Source:
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
  1. https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5507a1.htm
  2. 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
  3. 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