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.
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
  • 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

 

 

 

GSK is the sole manufacturer of PEDIARIX

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.

Ball image

 

See a video about the supply reliability of PEDIARIX

  • Video transcript

    ONSCREEN TEXT

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    ONSCREEN TEXT

    Why the supply reliability and single manufacturing profile of PEDIARIX matters to your practice1,2

    References: 1. Prescribing Information for PEDIARIX. 2. Data on file, GSK.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND (All audio is spoken by Dr. Friedland)

    GSK has been a proud supplier of PEDIARIX for over 20 years.

     

    ONSCREEN TEXT

    Dr. Leonard Friedland

    VP, Scientific Affairs & Public Health

    GSK Vaccines

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    Hi. My name is Len Friedland, and I’m the Vice President for Scientific Affairs and Public Health for GSK Vaccines. I’m a practicing pediatrician, fellowship trained in pediatric emergency medicine and a vaccine research scientist.

     

    This series of videos will explore the clinical, financial, and organizational benefits of using PEDIARIX and the other GSK DTaP-containing vaccines for your appropriate patients.

     

    ONSCREEN TEXT

    Supply Reliability

    Schedule Flexibility

    Efficacy and Safety

    Customer Solutions

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    Some of these attributes include schedule flexibility, the efficacy of PEDIARIX and its safety profile, and customer solutions, including cost-saving programs. In this video, we’ll look at the importance of supplier reliability to help keep your DTaP immunization routine from being disrupted.

     

    First, let’s take a look at the Indication for PEDIARIX.

     

    ONSCREEN TEXT

    Indication for PEDIARIX

    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-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    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-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).

     

    ONSCREEN TEXT

    When was the last time you experienced a vaccine supply disruption, and how did it impact your immunization routine?

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    In your practice, when was the last time you experienced a vaccine supply disruption, and how did it impact your immunization routine? What happened, or what would you imagine would happen, if you experienced supply shortages or delays? How would that affect your day-to-day vaccination routine?

     

    Bearing those questions in mind, I’d like to explain the importance of a reliable vaccine supplier for your patients and your practice, particularly with pediatric DTaP-containing vaccines.

     

    ONSCREEN TEXT

    There have been 3 DTaP-containing vaccine shortages and 1 pediatric HepB shortage in the last 12 years1,2*

    2012 – 2024

    Shortage 1: Non-GSK combination DTaP vaccine April 2012-July 2014 (820 days)2

    Shortage 2: Non-GSK DTaP-containing vaccine April 2012 – July 2014 (820 days)2

    Shortage 3: Non-GSK combination DTaP vaccine December 2015 – December 2016 (365 days)2

    Shortage 4: Non-GSK pediatric HepB vaccine August 2017 - March 2020 (940 days)2

     

    References: 1. CBER-regulated products: resolved shortages. US Food & Drug Administration website.
    https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm351943.htm. Updated November 2024. Accessed December 3, 2024. 2. CBER-regulated products: resolved shortages. US Food & Drug Administration. Updated August 12, 2020. Accessed December 3, 2024.
    https://wayback.archiveit.org/7993/20201222144346/https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-resolved-shortages

     

    *Data as of December 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.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    Let’s first take a look at the recent history of DTaP-containing vaccine shortages in the U.S., and one global pediatric hepatitis B vaccine shortage. In the last 12 years, there have been 3 DTaP containing vaccine shortages, ranging in duration from 365 days to 820 days.

     

    The first and longest DTaP shortage, a combination DTaP vaccine, began in April 2012 and was resolved July 2014.

     

    In this same time period, there was also a shortage of a non-combination, regular DTaP vaccine.

     

    The next DTaP shortage involved a combination DTaP vaccine. It began December 2015 and was resolved December 2016.

     

    In addition, a pediatric hepatitis B vaccine shortage, which began in August 2017, was not resolved until March of 2020.

     

    ONSCREEN TEXT

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    Now, take a moment to think about how even one of these shortages could have affected your practice or your patients. For example, what’s it like when you have to tell parents that you don’t have the vaccines needed to help protect their baby? How does it affect your staff when you give monovalent vaccines because the DTaP-containing combination vaccine that you use is out of stock?

     

    Let’s look at GSK and PEDIARIX in the context of these DTaP-containing vaccine shortages.

     

    ONSCREEN TEXT

    There have been 3 DTaP-containing vaccine shortages and 1 pediatric HepB shortage in the last 12 years1,2*

    2012 – 2024

    None of the 4 shortages included GSK’s DTaP- or pediatric HepB-containing vaccines.1,3

     

    References: 1. CBER-regulated products: resolved shortages. US Food & Drug Administration website.
    https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm351943.htm. Updated November 2024. Accessed December 3, 2024. 2. CBER-regulated products: resolved shortages. US Food & Drug Administration. Updated August 12, 2020. Accessed December 3, 2024.
    https://wayback.archiveit.org/7993/20201222144346/https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-resolved-shortages 3. Data on file, GSK.

     

    *Data as of December 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.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    It’s important to note that out of those 3 DTaP-containing vaccine shortages and 1 pediatric hepatitis B vaccine shortage that occurred, none involved a GSK vaccine. In fact, GSK has a history of helping health care professionals avoid disruption in their DTaP and HepB immunization routines by helping provide the US market with additional doses in times of DTaP shortages.

     

    ONSCREEN TEXT

    During these DTaP-containing vaccine shortages and the global pediatric HepB shortage, GSK supplied millions of additional doses to help reduce impact1

    Reference: 1. Data on file, GSK.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    During these DTaP-containing vaccine shortages and hepatitis B vaccine shortage, GSK responded by supplying millions of additional doses, specifically to help reduce the impact of market shortages.

     

    ONSCREEN TEXT

    Complete the Primary DTaP Series with PEDIARIX1,2

    [Chart showing vaccine needs and PEDIARIX coverage for first 6 months]

     

    DTaP=diphtheria, tetanus, and acellular pertussis. IPV=inactivated poliovirus vaccine.

    References: 1. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2025. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-age.html?CDC_AAref_Val=https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html. Updated November 21, 2024. Accessed December 3, 2024. 2. Prescribing Information for PEDIARIX.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    Let’s look at how these shortages could affect your DTaP immunization routine. The pediatric primary series calls for administration of appropriate DTaP-containing vaccines at 2, 4, and 6 months of age, so a DTaP shortage can be disruptive to completing this series in a timely manner. If vaccines are in short supply or not available, timing of subsequent vaccinations may be affected.

     

    ONSCREEN TEXT

    GSK is the sole manufacturer of PEDIARIX1:

    Reference 1. Prescribing Information for PEDIARIX.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    Something else to consider regarding vaccine shortages is manufacturing.

     

    ONSCREEN TEXT

    GSK is the sole manufacturer of PEDIARIX1:

    [Image of factory] Single manufacturer

    HELPS ENSURE INTEGRATION OF ANTIGEN SUPPLY

    Reference 1. Prescribing Information for PEDIARIX.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    All antigenic components of GSK DTaP-containing vaccines come from the same manufacturer—GSK. This helps ensure integration of our antigen supply, allowing the flexibility to respond to DTaP needs.

     

    ONSCREEN TEXT

    PEDIARIX has never had a vaccine shortage in its over 20-year history1,2

    Reference 1. Prescribing Information for PEDIARIX. 2. Data on file, GSK.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    PEDIARIX was the first combination DTaP vaccine on the market, and in its over 20-year history has never had a vaccine shortage.

     

    ONSCREEN TEXT

    Maximum discounts: cost-saving programs with optimized group pricing and multiple contract options

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    Beyond supply reliability, PEDIARIX supports your practice in other practical ways, with cost-savings programs such as optimized group pricing and multiple contract options. Contact your GSK Representative to learn more.

     

    ONSCREEN TEXT

    Thank you for partnering with GSK and PEDIARIX

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    We hope this video provided you a better understanding of how GSK has supported your practice as a reliable supplier of PEDIARIX. Thank you for partnering with GSK. We look forward to supplying the vaccines you need to help your patients and your practice.

     

    ONSCREEN TEXT

    Avoid disruption of your DTaP immunization schedule—think PEDIARIX

    Order PEDIARIX today: Call 1-866-475-8222. Visit GSKDirect.com or contact your GSK Sales Representative.

    Schedule a GSK Vaccine Business Review today to find out more about our Premium Partner program.

    For more information about PEDIARIX, please see the Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    You can order PEDIARIX today by calling 1-866-475-8222, by visiting GSKDirect.com or by contacting your GSK Sales Representative.

     

    For more information about PEDIARIX, please see the Important Safety Information and full Prescribing Information available at PEDIARIX.com.

     

    ONSCREEN TEXT

    Important Safety Information for PEDIARIX

     

    • Contraindications for PEDIARIX are: severe allergic reaction (for example, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine, or to any component of PEDIARIX; 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 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 (such as, temperature ≥105oF, 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

     

    Please see full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Important Safety Information for PEDIARIX.

     

    Contraindications for PEDIARIX are: severe allergic reaction (for example, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine, or to any component of PEDIARIX; 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 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 (such as, temperature ≥105oF, 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.

     

    ONSCREEN TEXT

    Important Safety Information for PEDIARIX (cont’d)

     

    • 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

     

    Please see full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    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.

     

    ONSCREEN TEXT

    Important Safety Information for PEDIARIX (cont’d)

     

    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination

    • In clinical trials, common adverse reactions in infants receiving PEDIARIX included injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite

    • Vaccination with PEDIARIX may not result in protection in all vaccine recipients

     

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2024 GSK or licensor.

    PMUS-PDRVID240003 December 2024

    Produced in USA.

     

    Please see full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination.

     

    In clinical trials, common adverse reactions in infants receiving PEDIARIX included injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite.

     

    Vaccination with PEDIARIX may not result in protection in all vaccine recipients.