Safety evaluation of the DTaP5-IPV-Hib-HepB vaccine: a review

Expert Opin Drug Saf. 2021 Nov 17. doi: 10.1080/14740338.2022.2007882. Online ahead of print.ABSTRACTINTRODUCTION: The DTaP5-IPV-Hib-HepB vaccine is the most recently approved combination hexavalent vaccine. In Europe, it is licensed since 2016 for primary and booster vaccination in infants and toddlers above the age of 6 weeks to provide active immunisation against diphtheria, tetanus, pertussis, poliomyelitis, invasive diseases caused by Haemophilus influenzae type b and hepatitis B. In the US, DTaP5-IPV-Hib-HepB is approved since 2018 in children 6 weeks through 4 years of age. Its safety profile has been extensively documented in infants and children born at term, and also data in preterm infants are made available.AREAS COVERED: In this article, we conducted a safety evaluation of the DTaP5-IPV-Hib-HepB vaccine in infants and toddlers considering evidence from clinical trials and post-marketing use, also with regard to data on special populations e.g. preterm infants.EXPERT OPINION: Based on the available data, the DTaP5-IPV-Hib-HepB vaccine has demonstrated a good safety profile, similar to that of other approved penta- and hexavalent vaccines. Rather, post-marketing data are limited and are frequently reported in combination with other hexavalent vaccines or are not adjusted for shares of vaccines use. Neither relevant interferences with other co-administered pediatric vaccines nor safety issues in premature infants have been shown.PMID:34787536 | DOI:10.1080/14740338....
Source: Expert Opinion on Drug Safety - Category: Drugs & Pharmacology Authors: Source Type: research