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Who Should not get Hepatitis B Vaccine?


who should not get this vaccine

According to the CDC anyone who has ever had a life-threatening allergic reaction to a previous dose of hepatitis B vaccine should not get another dose.  Anyone with a severe allergy to any part of the vaccine should not receive the vaccine. People who are moderately or severely ill at the time the vaccine is scheduled should wait until they recover before getting hepatitis B vaccine.

TwinRix (Hepatitis A and Hepatitis B combination vaccine) should not be administered to anyone younger than 18 years of age. Pediarix (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus combination vaccine) should not be administered to anyone younger than six weeks or older than six years of age.1

Also, information about contraindications (reasons why a person should not get a vaccine) to hepatitis B vaccine are contained in the manufacturer’s product information package insert that accompanies vials of vaccine provided to doctors and other medical personnel administering the vaccine.

  • According to Merck, Recombivax-HB should not be administered to anyone with a history of allergic or hypersensitivity reaction to any component of the vaccine, including yeast. The vial stopper and syringe plunger stopper and tip cap contain latex, which can cause allergic reactions. Caution should be used in administering this vaccine to any premature infant due to the risk of apnea. As well, this vaccine should be delayed at least 1 month (or until hospital discharge) for infants weighing less than 2,000 g (4.4 lbs) if the mother is known to be hepatitis B negative. It is unknown whether Recombivax-HB can cause fetal harm or affect reproduction and should only be administered to a pregnant woman if clearly needed. It is also unknown whether the vaccine is excreted in human milk and caution should be used when administering to nursing mothers.2
  • According to GlaxoSmithKline, Engerix-B should not be administered to anyone with a history of an allergic or hypersensitivity reaction to any component of the vaccine, including yeast. The tip cap of prefilled syringes contain latex, which can cause allergic reactions. Caution should be used in administering this vaccine to a premature infant due to the risk of apnea. As well, this vaccine should be delayed at least 1 month (or until hospital discharge) for infants weighing less than 2,000 g (4.4 lbs) if the mother is known to be hepatitis B negative. It is unknown whether Engerix-B can cause fetal harm or affect reproduction and should only be administered to a pregnant woman if clearly needed. It is also unknown whether the vaccine is excreted in human milk and caution should be used when administering to nursing mothers.3
  • According to GlaxoSmithKline, Twinrix (Hepatitis A & Hepatitis B) should not be administered to anyone who has ever had a severe (life-threatening) allergic reaction to a previous dose of hepatitis A or hepatitis B vaccine. Anyone who has a severe (life threatening) allergy to any vaccine component, including yeast and Neomycin, should not get the vaccine. The tip caps of the prefilled syringes contain latex and may cause allergic reactions in sensitive individuals. TwinRix is a pregnancy category C biological and it is unknown whether the vaccine can cause fetal harm or affect reproduction capacity. Caution is advised when considering administration of Twinrix to nursing mothers, as it is unknown whether the vaccine is excreted in human milk. Twinrix should be given with caution to persons with bleeding disorders, such as hemophilia or thrombocytopenia, and to persons on anticoagulant therapy. Twinrix should not be given to anyone under 18 years of age.4
  • According to GlaxoSmithKline, Pediarix (DTaP, Hepatitis B, Inactivated Polio) should not be given to anyone who has had a severe reaction to a previous dose of diphtheria toxoid, tetanus toxoid, pertussis antigen, poliovirus or hepatitis B vaccine or a component of the vaccine, including yeast and neomycin or polymyxin B antibiotics. The tip caps of the prefilled syringes contain latex, which may cause an allergic reaction. Infants and children who developed encephalopathy (example - coma, seizures, and decreased level of consciousness) within seven days of a pertussis-containing vaccine should not receive Pediatrix.. Also, any infant or child who developed a progressive neurological disorder, such as progressive encephalopathy, uncontrolled epilepsy and infantile spasms should not be given Pediarix. The manufacturer warns that if a fever of 105.7 F (40.5 C), collapse or shock-like state (hypotonic-hyporesponsive episode), persistent, inconsolable crying lasting three hours or more occurred within 48 hours, or if seizures (with or without fever) occurred within three days of a previous pertussis-containing vaccine, there should be careful consideration of the potential benefits and risks of giving Pediatrix. If Guillain-Barre syndrome occurred within six weeks of receiving a tetanus toxoid containing vaccine, careful consideration of the potential benefits and risks should be taken before administering Pediarix. Pediarix should not be given to anyone under the age of six weeks or over the age of six.5
  • According to Dynavax, HEPLISAV-B (adjuvanted recombinate vaccine) should not be given to adults with a history of severe allergic reactions to any previous hepatitis B vaccine, or any component of HEPLISAV-B, inclusive of yeast.6
  • According to the MCM Vaccine Company, VAXELIS (DTaP, inactivated polio, HIB conjugate, recombinant Hepatitis B) should not be administered to anyone with a history of a severe allergic reaction to a previous dose of VAXELIS, any ingredient found in VAXELIS, or any other tetanus toxoid, diphtheria toxoid, pertussis-containing vaccine, hepatitis B vaccine, inactivated poliovirus vaccine, or influenzae type b vaccine. VAXELIS should not be given to anyone who has suffered encephalopathy within seven days of a previous pertussis-containing vaccine with no other identifiable cause. Anyone with a history of progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy should not receive VAXELIS until a treatment regimen has been established and the condition has stabilized. Careful consideration should be given to the benefits and risks of VAXELIS before administering the vaccine to someone with a history of fever at or above 105 degrees F, a hypotonic-hyporesponsive episode, or persistent, inconsolable crying lasting more than three hours within 48 hours after a pertussis-containing vaccine, or who has suffered seizures within three days after a previous pertussis-containing vaccine. A causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome has been determined by the Institute of Medicine (IOM). If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following VAXELIS. Apnea in infants born prematurely has been associated with the administration of intramuscular injections, including VAXELIS. Administration of this vaccine should only be considered after careful assessment of the infant’s health status, along with the potential risks and benefits of vaccination. VAXELIS is approved for use in infants and children 6 weeks through 4 years of age, prior to their fifth birthday. Infants younger than 6 weeks of age, and children 5 years of age and older should not receive VAXELIS.7

IMPORTANT NOTE: NVIC encourages you to become fully informed about Hepatitis B and the Hepatitis B 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.

« Return to Vaccines & Diseases Table of Contents

References

1 FDA. Pediarix Package Insert.

2 FDA. Recombivax-HB Package Insert.

3 FDA. Engerix-B - Package Insert

4 FDA. TwinRix - Package Insert.

5 FDA. Pediarix Package Insert.

6 FDA. HEPLISAV-B – Package Insert.

7 FDA. VAXELIS – Package Insert


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