PedvaxHIB Vaccine
PedvaxHIB is an immunization against Hib disease, an infection with Haemophilus influenzae type b. Approximately 25% of infants develop fevers over 101ºF after their 1st and 2nd dose of PedvaxHIB.
What is PedvaxHIB?
Liquid PedvaxHIB® is a Haemophilus B Conjugate Vaccine. It is approved for routine immunization in infants and children between the ages of 2 months and 71 months of age. It is manufactured by Merck & Co. and approved by the FDA in 2011.
How is PedvaxHIB given?
Liquid PedvaxHIB is administered as an intramuscular injection. Infants 2-14 months old should receive a 0.5-mL dose, ideally at 2 months of age, followed by a 0.5-mL dose 2 months later (or as soon as possible).
When the primary 2-dose series is completed before the child is 12 months old, a booster dose of required between the ages of 15-71 months old. It is not approved for children over 6 years old.
Who should NOT get PedvaxHIB?
PedvaxHIB is not approved for infants under 6 weeks old, or anyone over 6 years old. It is NOT recommended for use in adult populations.
PedvaxHIB is not for people who are hypersensitive to any ingredient in the vaccine. People who develop symptoms of an allergic reaction after PedvaxHIB should not receive further doses of the vaccine.
There is latex in the vial stopper that may cause allergic reactions in people who are sensitive to latex.
What are the most common side effects of PedvaxHIB?
The risk of side effects depends on the dose number, but the most common problems generally include:
- Crying for more than 4 hours
- Diarrhea
- Ear infection
- Injection-site pain/soreness, redness, swelling
- Irritability
- Otitis media
- Pain
- Rash
- Sleepiness
- Unusual high-pitched crying
- Upper respiratory infection
- Vomiting
What is the risk of fever from PedvaxHIB?
Fevers over 101ºF were reported in 24% of infants between the ages of 2-6 months old within 48 hours of their 1st dose of PedvaxHIB.
Fevers over 101ºF were reported in 26.3% of infants between the ages of 2-6 months old within 48 hours of the 2nd dose of PedvaxHIB.
What severe side effects of PedvaxHIB were reported?
The use of Hib vaccines has been associated with early-onset Hib disease and Guillain-Barré Syndrome (severe muscle weakness), but a cause-and-effect relationship has not been established.
The following severe side effects have been linked to PedvaxHIB:
- Allergic reaction
- Angioedema
- Enlarged lymph nodes
- Febrile seizure
- Fever causing seizure
- Guillain-Barré Syndrome
- Lymphadenopathy
- Seizure
- Sterile injection-site abscess
- Thrombocytopenia
- Urticaria
What ingredients are in PedvaxHIB?
PedvaxHIB is a Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate). It is created with a Hib capsular polysaccharide that is chemically bound (conjugated) to a meningococcal protein.
Each 0.5-mlL does of Liqiuid PedvaxHIB is formulated to contain 7.5 mcg of Haemophilus B PRP, 125 mcg of Neisseria meningitidis outer membrane protein complex (OMPC), and 225 mcg of aluminum as amorphous aluminum phosphate sulfate, in 0.9% sodium chloride.
There is natural latex rubber in the vial stopper that can cause allergic reactions in latex-sensitive individuals.
PedvaxHIB does not contain lactose or thimerosal.
Where can I get more information?
- PedvaxHIB® Package Insert
- Liquid PedvaxHIB FDA Approval Information
- Pedvax HIB Vaccine Catch-Up Guidance – Centers for Disease Control
