New combination vaccine for children, researched at U of L, could reduce number of children’s shots if approved by FDA

A new combination vaccine, awaiting its approval by the federal Food and Drug Administration, may reduce the number injections a child in the U.S. must get in order to be fully immunized, according to a University of Louisville news release.

“Hopefully, this vaccine combination will improve coverage rates,” Gary S. Marshall, lead author of the study and professor of pediatrics, said in the release. “Studies show that when you use combination vaccines, more kids get vaccinated on time and by two years of age more are fully protected. When you make it easier, you get better coverage.”

The vaccine protects against six childhood diseases: diphtheria, tetanus, pertussis, polio, Haemophilus influenza type b, and hepatitis B. It could mean an infant receives one to four fewer injections, depending on which vaccine combinations are used, says the release.

“A similar hexavalent vaccine has been available in Europe for more than a decade and has resulted in more timely immunizations,” says the release.

U of L, led by Marshall, coordinated the multi-center trials for the vaccine, which included nearly 1,500 children across the U.S. Results from these trials are published in the August 2015 issue of Pediatrics.

The research determined the drug to be “effective, safe and well-tolerated,” says the release. The Pediatrics report said that the new vaccine provided equal immunity to the existing immunization regimen; children who were given the combination vaccine reported “a slightly higher rate of redness at the injection site and slightly higher rate of self-limited fever following the injections, as compared with the established regimen”; and no adverse health events were reported in either group for six months following the final dose.

“Once it is licensed, we can take pride in having brought this new vaccine to the pediatric community and having done our part to simplify the routine immunization schedule,” Marshall said.

FINANCIAL DISCLOSURE: Dr. Marshall has been an investigator on clinical trials funded by GlaxoSmithKline, Merck, Novartis, Pfizer and Sanofi Pasteur, and he also has received honoraria from these companies for service on advisory boards.
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