Pediatric Vaccine Gets FDA Approval


The FDA approved a pediatric vaccine combo to prevent four illnesses.

The US Food and Drug Administration (FDA) approved the new pediatric vaccine formulation for diphtheria, tetanus, pertussis, and poliomyelitis (DTaP) in 2015 and Sanofi announced that the vaccine is now available on January 31, 2017. This new vaccine has the potential to resolve issues of under-vaccination for these troubling diseases.

In approving Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus, or DTaP-IPV (Quadracel, Sanofi Pasteur), the FDA has cleared the way for a novel vaccine for children between 4 and 6 years of age that features a reduced dosing requirement.

The dosing schedule is notable because, according to a 2015 report from the Centers for Disease Control and Prevention (CDC), there is a adherence issue with the currently available four-plus dose formulations for the DTaP vaccine, with vaccine coverage dropping 11% between the third and fourth doses. In addition, there was reported to be a 12% drop-off from the primary to full series of Haemophilus influenzae type b (Hib). Overall, vaccine uptake for DTaP (84.6%) and Hib (82.7%) remains below the CDC’s target threshold of 90%, the report found.

Although the CDC report concluded that “nationally, coverage with vaccines recommended… for children aged 19-35 months remains high and stable,” it highlighted significant disparities in uptake among children in rural areas and those living below the federal poverty level, identifying potential access issues associated with existing vaccines.

“Far too many children remain under-vaccinated against serious diseases like pertussis, polio and Haemophilus influenzae type b disease,” David P. Greenberg, MD, Associate Vice President and Regional Medical Head North America, Sanofi Pasteur said in a statement. “We are committed to helping protect more children by making vaccination as easy and convenient as possible for parents and healthcare providers. The availability of [DTaP-IPV] is a step in this direction.”

With its sign-off, the FDA has cleared DTaP-IPV single-dose for use as a fifth dose in the DTaP series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series. Importantly, according to the company, DTaP-IPV can be used in children who have already started their immunization series with the four-dose vaccine, DTaP-IPV/Hib (Pentacel, Sanofi Pasteur), which was approved in 2008 for use in children between 6 weeks and 4 years of age, or the Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (Daptacel, Sanofi Pasteur), which was approved last year for children between 6 weeks and 6 years of age. A Sanofi spokesperson told Contagion® that the novel formulation is designed to “save an extra shot and may help improve vaccination coverage for children through 6 years of age.”

Currently, to protect infants and children from life-threatening diseases, the CDC recommends children 4 through 6 years of age receive the fifth dose of the DTaP vaccine and the fourth dose of IPV vaccine. The new formulation, DTAP-IPV is designed to provide these two vaccines in a single shot.

The novel formulation carries a small risk for allergic reactions, which typically occur immediately after receiving the vaccine. Side effects include pain, redness, and swelling at the injection site as well as muscle pain, fatigue, and headache.

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