Vaccine Info

Pediarix Vaccine

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Last reviewed
December 10, 2022
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Pediarix Vaccine Description - 2022

GSK's Pediarix multi-vaccine contains diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant), and inactivated poliovirus vaccine, approved by the U.S. FDA in 2002.

STN: BL 103907; CPT Code: 90723

Pediarix Indication

Pediarix is a vaccine for active immunization against diphtheria, tetanus, pertussis, and infection caused by all known subtypes of hepatitis B virus and poliomyelitis. 

Severe allergic reaction (e.g., 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.

Pediarix Dosage

Pediarix is approved for use as a three-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 (before the 7th birthday). Three doses (0.5-mL each) by intramuscular injection at 2, 4, and 6 months of age.

Pediarix News 2019 - 2022

August 1, 2022 - CDC says findings in the New York wastewater indicate others may be shedding the poliovirus as officials urge residents to ensure they are vaccinated.

February 9, 2022 - GSK reported Infanrix/Pediarix sales decreased 14% AER, 9% CER to £543 million, reflecting lower tender volume in Europe and International as well as a change in recommendation for the dosing schedule in Germany.

July 28, 2021 - GSK announced 'Sales of DTPa-containing vaccines (Infanrix, Pediarix, and Boostrix) grew by 45% AER, 55% CER. Infanrix/Pediarix sales rose 14% AER, 24% CER to £136 million, reflecting increased channel stock replenishment on wholesaler purchasing patterns and demand in the US, partly offset by a change in recommendation for the dosing schedule in Germany and supply constraints in Europe. Boostrix sales grew 92% AER and more than 100% CER to £146 million, largely driven by higher demand in the US and internationally.

December 31, 2020 - According to Reuters, for the new year, GSK plans to hike prices on two of their vaccines, Shingrix and Pediarix.  These price increases are a direct result of the COVID-19 pandemic and the reduced number of doctor visits, thus reducing the number of vaccinations given.

June 2, 2020 - COVID-19 Impact on Global Human Vaccines Market Size, Shares, Trends, Demands, Types, Applications & Key Industry Players - Sanofi Pasteur, Merck, Pfizer, AstraZeneca, Valneva, GSK, Seqirus.

September 17, 2019 - Merck HepB vaccine shortage extended through mid-2020.

Pediarix Clinical Trials

GSK's Pediarix has been in many studies to test immunogenicity, safety, and reactogenicity.