A branded formulation is marketed in the U.S. as Pediarix by GlaxoSmithKline.[5]
DTaP
The DTaP portion of the vaccine protects against three bacterial infections: diphtheria, tetanus, and pertussis (whooping cough). Diphtheria is a bacterium that causes problems with breathing, heart failure, paralysis, and in some cases death.[6] It is spread via human to human interaction.[6] Tetanus is spread via open cuts or wounds in the body. It can lead to stiffening of the muscles, which can result in difficulties breathing.[6] Pertussis, also known as whooping cough, is the is "aP" portion of the DTaP vaccine.[6] Like diphtheria, it is spread via human to human interaction.[6] With the vaccine, children can build up a supply of antibodies that prevent infection.[7] In general, the DTaP vaccine is only administered to children ages 7 and younger.[6]
IPV
The IPV portion of the DTaP-IPV-HepB vaccine protects against poliomyelitis, otherwise known as polio.[8] IPV stands for inactivated poliovirus vaccine, which means that it does not use a live strand of the polio virus and cannot result in polio.[8] Polio is a life-threatening disease that can cause paralysis, poor muscle function that weakens the ability to breath, and brain problems.[8][9] Since 2016, the United States requires all polio vaccines administered to be IPV and not OPV to eliminate the use of live polio virus.[8]
HepB
The HepB portion of the vaccine protects against hepatitis B. Hepatitis B is a virus that can be spread via mother to child if the mother is infected with hepatitis B, so most doctors recommend that infants be vaccinated.[10] In most individuals infected with hepatitis B, they are asymptomatic.[10] However, symptoms of hepatitis B include flu-like symptoms, diarrhea, and jaundice.[10] Hepatitis B can either be acute or chronic and can ultimately lead to damage of the liver.[10]
Uses
The main reason for the use of combination vaccines is because they require fewer shots. Instead of having a child receive separate shots for each virus they need protection from, scientists were able to create vaccines, like MMR and DTap-IPV-HepB, that protect against several viruses at a time.[11] Another reason is that with the IPV (inactivated poliovirus vaccine) portion of the DTap-IPV-HeB vaccine, children no longer have to take the oral vaccine (OPV) that was administered starting in the 1950s.[12] Although the oral vaccine helped eliminate polio in several countries and is still used in countries today, OPV contains live polio virus and can still result in individuals getting polio.[12][8] Combination vaccines are also more cost effective and make it more likely for children to receive vaccinations.[11][7] With the DTaP vaccine on its own, it is to be administered in five doses.[6] However, when the DTaP vaccine is administered through the DTaP-IPV-HepB combination vaccine like Pediarix, it only has to be administered in three doses.[13]
Formulations
In general, the DTaP-IPV-HepB vaccine is recommended to be administered in three doses around 8, 12, and 16 weeks old.[9] Talk to your doctor about the vaccine schedule that is best for your child. There are several common DTaP combinations vaccines: Pediarix, Kinrix, and Pentacel.[11] Pediarix combines DTap-IPV-Hep B and Pentacel combines DTaP-IPV-Hib (Haemophilus influenza type b); however, Kinrix only combines DTaP-IPV, which leaves out Hep B and Hib.[11] Therefore, Pediarix and Pentacel are more commonly used because they protect from five rather than four viruses in each dose.[11] For protecting against DTaP viruses, polio, and hepatitis B, Pediarix is the recommended formulation.[11]
Pediarix
Pediarix is vaccine that is protective against diphtheria, tetanus, pertussis, hepatitis B, and polio.[14] This vaccine is FDA approved to be administered to infants in three doses between ages six weeks and six years.[14] Pediarix should not be injected into any child seven years old or older.[14] However, it is recommended that the immunizations be done at months two, four, and six.[15] The wide age gap between six weeks and six years allows for children who fall behind in their vaccinations to still have the opportunity to be vaccinated.[16] From the moment of birth, babies can become infected with these life-threatening diseases, which is why this vaccine is recommended to be given so early on.[9] With these three doses, the Pediarix vaccine has been given to over 8,088 infants.[13] Each does is 0.5mL and is given via intramuscular.[15] For children ages one and younger, the vaccine is injected into the thigh.[15] While for children older than one, it is injected into the deltoid muscle of the arm.[15] Because the Pediarix vaccine has HepB, is it important to note the mother's HBsAg status.[16] Pediarix is recommended for mothers who are HBsAg-negative; however, in 2003 it was approved that children whose mothers are HBsAg-positive can also receive the Pediarix immunization.[16] Looking at overall completed vaccine records, Pediarix completes the amount of HepB doses that an individual needs to be protected.[16] However, boosters are still needed for DTaP and IPV vaccines after the three doses of Pediarix.[16]
DTaP-IPV-HepB virus activity
As of 2021, there were 1,609 cases of pertussis in the United States.[17] The majority of cases were found amongst 6-11 month old children.[17]
^Centers for Disease Control and Prevention (CDC) (March 2003). "FDA licensure of diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant), and poliovirus vaccine combined, (PEDIARIX) for use in infants". MMWR. Morbidity and Mortality Weekly Report. 52 (10): 203–204. PMID12653460.
^Centers for Disease Control and Prevention (CDC) (October 2008). "Licensure of a diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine and guidance for use as a booster dose". MMWR. Morbidity and Mortality Weekly Report. 57 (39): 1078–1079. PMID18830212.
^ abcCenter for Biologics Evaluation and Research (6 November 2019). "PEDIARIX". FDA. Archived from the original on 22 September 2019. Retrieved 16 December 2019.