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What is Hepatitis A vaccine?


hepatitis a

The CDC’s Advisory Committee on Immunization Practices currently recommends that all children receive the first dose of hepatitis A vaccine between 12 and 23 months of age and the second dose is recommended 6 months or longer following the first dose of the vaccine. Additionally, hepatitis A vaccination is recommended for person considered at high risk for developing hepatitis A related to travel, employment, pre-existing health issues, lifestyle and in the event of an outbreak situation.1

Read the Product Information Insert

NVIC strongly recommends reading the vaccine manufacturer product information insert before you or your child receives any vaccine, including a shot containing hepatitis A vaccine. Product inserts are published by drug companies making vaccines and list important information about vaccine ingredients, reported health problems (adverse events) associated with the vaccine, and directions for who should and should not get the vaccine.

Links to hepatitis A vaccine product inserts are available below or you can ask your doctor to give you a copy of the vaccine product insert to read before you or your child is vaccinated. It is best to ask your doctor for a copy of the product inserts for the vaccines you or your child is scheduled to receive well in advance of the vaccination appointment.

Hepatitis A Vaccines Licensed for Use in the U.S.

The U.S. Food and Drug Administration and U.S. Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) has approved three different hepatitis A containing shots. There are different rules for use of these vaccines by different aged groups.

VAQTA: a vaccine containing inactivated hepatitis A vaccine virus approved for use in adults and children 12 months of age and older. This vaccine is manufactured by Merck. Two doses of VAQTA vaccine are recommended and doses should be given at least six months apart or longer.2

VAQTA vaccine is made from hepatitis A virus grown in human MRC-5 diploid fibroblasts. Human MRC-5 cells are derived from a cell line that was developed in 1966 from lung tissue taken from a 14 week aborted fetus and contains viral antigens.3 The inactivated strain is derived by the further processing of an attenuated strain that has been grown, selected, purified and inactivated by formalin. Following inactivation, the virus is combined with amorphous aluminum hydroxyphosphate sulfate, an aluminum adjuvant with the potential to cause autoimmune/auto inflammatory conditions and noted to be linked to adverse events.4

Each adult dose of VAQTA contains 50U of hepatitis A virus antigen and 450mcg of aluminum in the form of amorphous aluminum hydroxyphosphate sulfate. Each pediatric dose of VAQTA contains 25U of hepatitis A virus antigen and 225 mcg of aluminum. VAQTA also contains DNA, non-viral protein, bovine albumin, formaldehyde, neomycin, sodium borate, and sodium chloride.5 6

The vial stopper, the syringe plunger stopper, and the tip cap contain dry natural latex rubber that may cause allergic reactions in latex-sensitive persons.7

HAVRIX: a vaccine containing inactivated hepatitis A vaccine virus approved for use in adults and children 12 months of age and older. This vaccine is manufactured by GlaxoSmithKline. Two doses of HAVRIX vaccine are recommended and doses should be given at least six months apart or longer.8

HAVRIX vaccine is manufactured by propagating the hepatitis A virus in MRC-5 human diploid cells. Human MRC-5 cells are derived from a cell line that was developed from lung tissue taken from a 14 week aborted fetus in 1966 and contains viral antigens.9 The cells are lysed to form a suspension and purified. It is inactivated by formalin and absorbed into aluminum hydroxide.10

Each 1-ml adult dose of the vaccine contains 500mcg of aluminum and each 0.5ml pediatric dose contains 250mcg of aluminum, both in the form of aluminum hydroxide.11

Additional ingredients in the vaccine include MRC-5 human diploid cells, polysorbate 20, formalin, neomycin sulfate, amino acid supplement in a phosphate-buffered saline solution, and an aminoglycoside antibiotic.12 13

TWINRIX: a vaccine containing both inactivated hepatitis A vaccine (HAVRIX) and hepatitis B recombinant vaccine (ENGERIX-B) approved for use in adults 18 years of age and older. This vaccine is manufactured by GlaxoSmithKline. There are two different dosing options for TWINRIX vaccine. The most common dosing schedule of TWINRIX vaccine involves the administration of three vaccine doses, with the second dose administered one month following the initial dose, and the third dose administered six months after the first dose was administered. An accelerated dosing option has also been approved and involves three doses administered within three weeks, with the second dose at Day 7 and the third dose at Day 21, followed by a fourth dose at 12 months. 14

TWINRIX vaccine is bivalent vaccine containing the HAVRIX vaccine (see above) and the ENGERIX-B (hepatitis B vaccine). ENGERIX-B is comprised of a suspension of hepatitis B virus surface antigen (HBsAg) and contains purified surface antigen of the hepatitis B virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells (yeast cells), which carry the surface antigen gene of the hepatitis B virus. The HBsAg expressed in the cells is purified and adsorbed on aluminum hydroxide. ENGERIX-B should contain no more than 5 percent yeast protein.15

Each 1-ml dose of TWINRIX contains 450mcg of aluminum, in the form of aluminum hydroxide and aluminum phosphate, as an adjuvant. Additional ingredients in the vaccine include formalin, amino acids, phosphate buffer, polysorbate 20, sodium chloride, neomycin sulfate, yeast protein, and MRC-5 human diploid cells (residual DNA).16 17

The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.18

Is the Hepatitis Vaccine Mandated?

Federal health officials make recommendations for vaccine use and states enact laws that require vaccine use. Currently, 22 states and the District of Columbia require hepatitis A vaccine for either childcare enrollment, K-12 school enrollment, or both.19  Medical exemptions to vaccination are allowed in every state but few medical conditions qualify for a medical exemption, which must be written by a medical doctor (M.D.) or Doctor of Osteopathy (D.O.) or other licensed professional approved by the state.

Depending upon which state you live in, you may be legally allowed to exercise a religious or philosophical/conscientious belief exemption to vaccination, including hepatitis A vaccination. For more information about which vaccines your state requires and exemptions, go here on NVIC’s website.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Hepatitis A and the Hepatitis A vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

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References

1 CDC Prevention of Hepatitis A Through Active or Passive Immunization Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. May 19, 2006; 55(RR07);1-23

2 FDA VAQTA Product Insert Dec. 20, 2018

3 Jacobs JP The status of human diploid cell strain MRC-5 as an approved substrate for the production of viral vaccines. J Biol Stand. 1976 Apr;4(2):97-9.

4 Mold M, Shardlow E, Exley C Insight into the cellular fate and toxicity of aluminium adjuvants used in clinically approved human vaccinations Sci Rep. 2016; 6: 31578.

5 FDA VAQTA Dec. 20, 2018

6 CDC Vaccine Excipient & Media Summary Excipients Included in U.S. Vaccines, by Vaccine Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015. Updated Oct. 2018

7 FDA VAQTA Product Insert Dec. 20, 2018

8 FDA HAVRIX Product Insert Dec. 19, 2018

9 Jacobs JP The status of human diploid cell strain MRC-5 as an approved substrate for the production of viral vaccines. J Biol Stand. 1976 Apr;4(2):97-9.

10 FDA HAVRIX Product Insert Dec. 19, 2018

11 Ibid

12 Ibid

13 CDC Vaccine Excipient & Media Summary Excipients Included in U.S. Vaccines, by Vaccine Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015. Updated Oct. 2018

14 FDA TWINRIX Product Insert Dec. 18, 2018

15 Ibid

16 Ibid

17 CDC Vaccine Excipient & Media Summary Excipients Included in U.S. Vaccines, by Vaccine Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015. Updated Oct. 2018

18 FDA Twinrix Dec. 18, 2018

19 Immunization Action Coalition State Information - Hepatitis A Vaccine Mandates for Children in Daycare Facilities, Elementary, and Secondary Schools. Nov. 11, 2018


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