Recombivax HB Vaccine

Recombivax HB is a vaccine against Hepatitis B for people of all ages. It is given in a series of 3 shots. The most common side effects are injection-site reactions.

What is Recombivax HB?

Recombivax HB® is a recombinant Hepatitis B vaccine. It is indicated for prevention of infection caused by all known subtypes of Hepatitis B viruses. Recombivax HB is approved for individuals of all ages. It was approved by the FDA in 1983 and manufactured by Merck & Co.

What is a recombinant vaccine?

Recombinant vaccines contains non-infectious parts of the virus, rather than a live virus or an attenuated (weakened) virus.

Recombivax contains synthetic Hepatitis B surface antigen (HBsAg) produced in yeast cells. A plasmid containing the DNA of a Hepatitis B virus that codes for HBsAg is cloned into yeast cells. Recombivax HB is made from cell cultures of this recombinant yeast strain.

What is the immunization schedule for Hepatitis B?

Infant, children and adolescents (0-19 years of age) can receive three shots, 0.5-mL each, given on a 0-month, 1-month, and 6-month schedule. Most children start immunization as soon as they are born.

Adolescents between the ages of 11 and 15 years old can receive two shots, 1-mL each. The second shot is given 4-6 months after the first.

Adults over 20 years old can receive three shots, 1-mL each, given on a 0-month, 1-month, and 6-month schedule.

Pre-dialysis and dialysis patients can receive three shots of the Dialysis Formulation, 1.0-mL each, given on a 0-month, 1-month, and 6-month schedule.

How is Recombivax HB given?

Recombivax HB is an intramuscular injection. The preferred injection site is the deltoid muscle of the upper arm for adults, adolescents, and children who are at least 1 year old. The thigh is the preferred injection site for infants younger than 1 years old.

Who should NOT get Recombivax HB?

Recombivax HB is contraindicated in anyone who has experienced a severe hypersensitivity reaction (e.g. anaphylaxis) after a previous dose of any Hepatitis B-containing vaccine, or to any other ingredient in Recombivax HB, including yeast.

What are the most common side effects of Recombivax HB?

In healthy infants and children (up to 10 years old), the most common side effects of Recombivax HB were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and runny nose.

In health adults, the most common side effects were injection site-reactions (17%) and systemic side effects (15%). The injection-site reactions may include soreness, pain, tenderness, rash, redness, swelling, warmth, or nodule formation.

People who receive Recombivax can develop the following side effects:

• Abdominal pain
• Achiness
• Angioedema
• Back pain
• Chills
• Cough
• Cramps
• Diarrhea
• Diminished appetite
• Dizziness
• Earache
• Enlarged lymph nodes
• Fatigue
• Fever over 100ºF
• Flu-like symptoms
• Flushing
• Headache
• Hypotension
• Influenza
• Injection-site reactions
• Insomnia
• Joint pain
• Light-headedness
• Low blood pressure
• Lymphadenopathy
• Malaise (generally feeling unwell)
• Myalgia
• Muscle pain
• Nausea
• Neck pain and stiffness
• Paresthesia
• Pruritis
• Rash (non-specific)
• Runny nose
• Sensation of warmth
• Shoulder pain
• Sweating
• Upper respiratory tract infection
• Upset stomach
• Urticaria
• Vertigo
• Vomiting
• Weakness

What are severe side effects of Recombivax HB?

Allergic reactions are a rare but serious side effect of Recombivax HB. The vaccine contains latex and it may trigger allergic reactions in hypersensitive individuals.

Apnea (temporarily stop breathing) after vaccination has been observed in some premature infants. Decisions about whether to delay vaccination to infants born prematurely should be based on the consideration of the individual’s medical status and possible risks.

Shoulder Injury Related to Vaccine Administration (SIRVA) can occur if the vaccine needle damages ligaments, tendons, or punctures the bursa in the shoulder. This can result in chronic pain and limited shoulder mobility.

What other side effects have been reported?

• Agitation
• Allergic reaction
• Alopecia
• Anaphylaxis
• Arthritis
• Asthma-like symptoms
• Autoimmune diseases
• Bell’s Palsy
• Breathing problems
• Bronchospasm
• Conjunctivitis
• Constipation
• Eczema
• Elevation of liver enzymes
• Encephalitis (brain inflammation)
• Erythema multiforme
• Exacerbation of multiple sclerosis
• Facial paralysis
• Febrile seizure
• Fever
• Guillain-Barré Syndrome
• Heart problems
• Herpes zoster
• Hypesthesia
• Increased erythrocyte sedimentation rate
• Irritability
• Joint pain
• Lupus like syndrome
• Migraine
• Multiple sclerosis
• Muscle weakness
• Myelitis
• Nerve damage
• Optic neuritis
• Pain in the extremity
• Peripheral neuropathy
• Petechiae
• Polyarteritis nodosa
• Radiculopathy
• Seizures
• Serum sickness symptoms
• Sleepiness
• Skin reactions
• Stevens Johnson Syndrome
• Systemic Lupus Erythematosus (SLE)
• Tachycardia
• Thrombocytopenia
• Transverse myelitis
• Uveitis
• Vasculitis
• Visual disturbances

What ingredients are in Recombivax HB?

Recombivax HB is supplied in three formulations:

• • Pediatric/Adolescent Formulation (No Thimerosal or Preservatives) 10 mcg/mL: each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen.
  • Adult Formulation (No Thimerosal or Preservative) 10 mcg/mL: each 1 mL dose contains 10 mcg of hepatitis B surface antigen.
  • Dialysis Formulation (No Thimerosal or Preservative) 40 mcg/mL: each 1 mL dose contains 40 mcg of hepatitis B surface antigen.

The vaccine contains less than 15 mcg/mL residual formaldehyde.

All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine.

Where can I get more information?

• Recombivax HB Package Insert (PDF)
• Hepatitis B Vaccine Schedule
• Learn More About Hepatitis B Vaccines