SUPPLY RELIABILITY

Continue your DTaP immunization routine without interruption with PEDIARIX*

PEDIARIX has never had a supply shortage in more than 2 decades.1,2 Other manufacturers have had primary series DTaP-containing or pediatric HepB vaccine shortages that lasted a year or more.3,4

There have been 3 DTaP-containing vaccine shortages and 1 pediatric HepB vaccine shortage in the last 12 years3,4,†

No supply shortage. None of the 4 shortages included GSK's DTaP- or pediatric HepB-containing vaccines.
  • GSK distributed millions of additional doses to cover for 3 US DTaP-containing vaccine shortages and the global pediatric HepB vaccine shortage to help reduce negative impact2
  • Shortages ranged from approximately 365 days to 940 days3,4
  • *

    Data are not available on the safety and effectiveness of using PEDIARIX following one or more doses of a DTaP vaccine from a different manufacturer.1

  • †

    Data as of November 2024. Shortages of vaccines were identified by the Center for Biologics Evaluation and Research (CBER) within the Food and Drug Administration. CBER works closely with the manufacturer to voluntarily obtain accurate information.

More than 100 million doses

More than 100 million doses of PEDIARIX have been distributed in the United States since 2003.2

When it comes to supply reliability, PEDIARIX has a convincing track record, and has helped you protect a generation of babies.1,2

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GSK is the sole manufacturer of PEDIARIX

GSK is the single manufacturer of all the antigens in PEDIARIX. GSK has a consistent DTaP vaccine supply record for over 20 years, giving you the confidence of supply reliability.1,2,5

  • A single antigen source helps to ensure integration of antigen supply and flexibility to respond to your DTaP vaccine needs

DTaP=diphtheria, tetanus, and acellular pertussis; HepB=hepatitis B.

See a video about the supply reliability of PEDIARIX

INDICATIONS & IMPORTANT SAFETY INFO FOR PEDIARIX, INFANRIX, AND KINRIX

INDICATIONS FOR PEDIARIX, INFANRIX, AND KINRIX

IMPORTANT SAFETY INFORMATION FOR PEDIARIX, INFANRIX, AND KINRIX

INDICATIONS FOR PEDIARIX, INFANRIX, AND KINRIX

PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).  

INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years of age (prior to seventh birthday).

A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] for the first 3 doses and INFANRIX for the fourth dose.

Indication for HIBERIX 

HIBERIX is indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday).

Indication for ENGERIX-B  

ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.

IMPORTANT SAFETY INFORMATION FOR PEDIARIX, INFANRIX, AND KINRIX

  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine or to any component of PEDIARIX is a contraindication for PEDIARIX 
  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine or to any component of INFANRIX is a contraindication for INFANRIX
  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, or poliovirus-containing vaccine or to any component of KINRIX, including neomycin and polymyxin B, is a contraindication for KINRIX
  • Additional contraindications for PEDIARIX, INFANRIX, and KINRIX are: encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders
  • In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines
  • The decision to give PEDIARIX, INFANRIX, or KINRIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (ie, temperature ≥105°F, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine
  • The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton
  • Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX, INFANRIX, or KINRIX
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX or INFANRIX should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination 
  • In clinical trials of PEDIARIX and INFANRIX, common adverse reactions were injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite. In clinical trials of KINRIX, common adverse reactions were injection-site reactions (pain, redness, increase in arm circumference, and swelling), drowsiness, fever, and loss of appetite
  • Vaccination with PEDIARIX, INFANRIX, or KINRIX may not result in protection in all vaccine recipients
IMPORTANT SAFETY INFORMATION FOR HIBERIX
  • Contraindications for HIBERIX: severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b­ or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of HIBERIX
  • If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including HIBERIX, should be based on careful consideration of the potential benefits and possible risks
  • Syncope (fainting) can occur in association with administration of injectable vaccines, including HIBERIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including HIBERIX, to infants born prematurely should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination
  • Prior to administration, the healthcare provider should review the patient's immunization history for possible vaccine hypersensitivity. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur
  • Safety and effectiveness of HIBERIX in immunosuppressed children have not been evaluated. If HIBERIX is administered to immunosuppressed children, including children receiving immunosuppressive therapy, the expected immune response may not be obtained
  • Urine antigen detection may not have a diagnostic value in suspected disease due to H. influenzae type b within 1 to 2 weeks after receipt of an H. influenzae type b-containing vaccine, including HIBERIX
  • Immunization with HIBERIX does not substitute for routine tetanus immunization
  • Common solicited adverse reactions (≥20%) were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, sleepiness, fussiness, and restlessness
  • Vaccination with HIBERIX may not result in protection in all vaccine recipients
IMPORTANT SAFETY INFORMATION FOR ENGERIX-B
  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B-containing vaccine, or to any component of ENGERIX-B, including yeast, is a contraindication to administration of ENGERIX-B
  • The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton
  • Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • Temporarily defer ENGERIX-B vaccination of infants with a birth weight less than 2,000 grams born to hepatitis B surface antigen (HBsAg)-negative mothers
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely
  • lmmunocompromised persons, including individual receiving immunosuppressive therapy, may have a diminished immune response to ENGERIX-B
  • In clinical trials with ENGERIX-B, the most frequently reported adverse reactions were injection-site soreness and fatigue
  • Vaccination with ENGERIX-B may not result in protection in all vaccine recipients

 

Prescribing Information for PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]

Prescribing Information for INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

Prescribing Information for KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)

Prescribing Information for HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]

Prescribing Information for ENGERIX-B [Hepatitis B Vaccine (Recombinant)]

References

  1. Prescribing Information for PEDIARIX.
  2. Data on file, GSK.
  3. CBER-regulated products: shortages and discontinuations. US Food & Drug Administration. Updated October 15, 2018. Accessed December 10, 2024. https://wayback.archive-it.org/7993/20190207185117/https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm351943.htm
  4. CBER-regulated products: resolved shortages. US Food & Drug Administration. Updated November 22, 2024. Accessed December 10, 2024. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-resolved-shortages.
  5. Prescribing Information for INFANRIX.