In 2018, FDA licensed Vaxelis for use in children age 6 weeks through 4 years: it is indicated as a 3-dose series for infants at ages 2, 4, and 6 months. ACIP voted to add Vaxelis to the Vaccines for Children (VFC) Program in 2019.
The MSP Vaccine Company was created as a joint venture between Merck and Sanofi Pasteur to produce Vaxelis. Vaxelis contains the same DTaP components as Pentacel (Sanofi Pasteur). The IPV component is the same as IPOL (Sanofi Pasteur). The Hib component is the same as PedvaxHIB (Merck), but in a decreased amount. The HepB component is the same as the pediatric formulation of Recombivax HB (Merck), but in an increased amount. Vaxelis is a liquid vaccine that does not require reconstitution.
The complete recommendations for the use of Vaxelis are available at: www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6905a5-H.pdf.
Last reviewed:
July 15, 2023
Yes. Vaxelis may be used for children younger than age 5 years requiring a catch-up primary series, using appropriate minimum intervals. It is not approved as the booster dose of DTaP [dose 4 or 5] or IPV [dose 4] or Hib [dose 4]. If Vaxelis is inadvertently given as a booster dose, it may count as valid and does not need to be repeated.
Last reviewed:
July 15, 2023
Historically, AI/AN infants were more likely than other U.S.-born infants to develop Hib meningitis before being old enough to complete a primary series of Hib-containing vaccine. ACIP prefers that AI/AN infants be vaccinated with PedvaxHIB because it can stimulate protective levels of antibodies after the first dose.
Vaxelis contains the same Hib vaccine components as PedvaxHIB, but in smaller quantities. At the time ACIP approved Vaxelis, no data were available on the immune response to the Hib component of Vaxelis after the first dose, so ACIP did not make a preferential recommendation for Vaxelis in AI/AN infants. ACIP stated it would re-evaluate its decision if new information becomes available.
Last reviewed:
July 15, 2023
Fever after vaccination was more common, reported in almost half of infants, compared to about one-third of infants who received Pentacel (DTaP-IPV/Hib). However, the rates of fever-related medical visits or febrile seizures were similar in both groups.
Last reviewed:
July 15, 2023
