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Who should not get Hepatitis A vaccine?


who should not get

According to the CDC, certain persons should not get hepatitis A vaccine, or should postpone getting it. Those persons are:1

  • Anyone who has ever had a severe (life-threatening) allergic reaction to a previous dose of hepatitis A vaccine or to any component of the hepatitis A vaccine. It is important to tell your doctor if you have any severe allergies.
  • Anyone who is moderately or severely ill at the time the shot is scheduled should wait until they recover before receiving hepatitis A vaccine.

While the CDC recommends that infants 6 to 11 months of age traveling outside the United States receive a dose of hepatitis A vaccine,2 both VAQTA and HAVRIX are not FDA approved for use in children under the age of 12 months. Further, product inserts for both VAQTA and HAVRIX state that the safety and effectiveness of their products have not been established in children younger than 12 months of age.3 4

VAQTA: Contraindications to receiving the VAQTA (hepatitis A inactivated) vaccine documented in Merck’s product insert include persons who have experienced a severe allergic reaction or anaphylaxis to any component of VAQTA, including neomycin, or to a previous dose of any hepatitis A vaccine. As well, both the syringe plunger and vial stopper of VAQTA contain latex that may cause an allergic reaction in persons who are sensitive to latex. 5

Merck also cautions that immunocompromised individuals and persons receiving immunosuppressive therapy may have a decreased immune response to vaccination with VAQTA.6

VAQTA is approved for use in children and adults 12 months and older. Children under the age of 12 months should not receive VAQTA.7

There are no adequate and well-controlled studies designed to evaluate VAQTA in pregnant women. It is also unknown whether VAQTA is excreted in human milk. 8

HAVRIX: Contraindications to receiving the HAVRIX (hepatitis A inactivated) vaccine documented in GlaxoSmithKline’s insert include persons who have experienced anaphylaxis or a severe allergic reaction to a previous dose of any hepatitis A vaccine or to any component of HAVRIX, including neomycin. The tip caps of the prefilled HAVRIX vaccine syringes contain latex and may cause an allergic reaction in individuals who are sensitive to latex. 9

GlaxoSmithKline also cautions that fainting may occur following administration with HAVRIX and can include symptoms such as paresthesia, tonic-clonic limb movements, and visual disturbances. Immunocompromised individuals and persons receiving immunosuppressive therapy may have a decreased immune response to HAVRIX. 10

HAVRIX is approved for use in children and adults 12 months and older and children under the age of 12 months should not receive HAVRIX.

There are no adequate and well-controlled studies of HAVRIX in pregnant women in the United States and no animal studies have ever been completed to guide the use of HAVRIX during pregnancy. There is no information regarding HAVRIX in human milk, the effects of HAVRIX on the breastfeeding child, or the impact that the vaccine may have on milk production. 11  

Clinical trials of HAVRIX vaccine did not include a sufficient number of persons above the age of 65 years and it is unknown whether this population responds to HAVRIX in a similar manner as the younger population.12

TWINRIX: Contraindications to receiving the TWINRIX (hepatitis A inactivated/hepatitis B Recombinant) vaccine documented in GlaxoSmithKline’s insert include persons who have experienced a severe allergic reaction to a previous dose of any hepatitis A or hepatitis B vaccine or to any component of TWINRIX, including yeast and neomycin. The tip caps of the prefilled TWINRIX vaccine syringes contain latex and may cause an allergic reaction in individuals who are sensitive to latex. 13

GlaxoSmithKline also cautions that syncope can occur following administration of TWINRIX and can include symptoms such as tonic-clonic limb movements, visual disturbances and paresthesia. GlaxoSmithKline recommends postponing vaccination with TWINRIX in persons who are exhibiting signs of moderate or severe acute illness to avoid any confusion between a possible reaction to the vaccine and signs of an impending acute infection.14

Immunocompromised individuals and persons receiving immunosuppressive therapy may have a decreased immune response to TWINRIX. In clinical trials, TWINRIX was not studied for use with any other vaccine and no information on safety or effectiveness of giving TWINRIX simultaneously with any other vaccine is available. 15

TWINRIX is approved for use in persons 18 years of age and older. Persons under the age of 18 should not receive TWINRIX. Clinical trials of TWINRIX did not include a sufficient number of persons over the age of 65 years of age and it is unknown whether this population responds to TWINRIX in a similar manner as the younger population.16

There are no well-controlled and adequate studies of TWINRIX in pregnant women in the United States. There is no information regarding TWINRIX in human milk, the effects of TWINRIX on the breastfeeding child, or the impact that the vaccine may have on milk production.17

NVIC Note: Some doctors only vaccinate children who are healthy and are not sick at the time of vaccination with a coinciding viral or bacterial infection. If you do not want your acutely ill child vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

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 Hepatitis A VIS. Jul. 20, 2016

2 CDC Update: Recommendations of the Advisory Committee on Immunization Practices for Use of Hepatitis A Vaccine for Postexposure Prophylaxis and for Preexposure Prophylaxis for International Travel MMWR Nov. 2, 2018; 67(43);1216–1220

3 FDA VAQTA Product Insert Dec. 20, 2018

4 FDA HAVRIX Product Insert Dec. 19, 2018

5 FDA VAQTA Product Insert Dec. 20, 2018

6 Ibid

7 Ibid

8 Ibid

9 FDA HAVRIX Product Insert Dec. 19, 2018

10 Ibid

11 Ibid

12 Ibid

13 FDA TWINRIX Product Insert Dec. 18, 2018

14 Ibid

15 Ibid

16 Ibid

17 Ibid


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