By Marie Rosenthal, MS
In a unanimous vote, the CDC’s Advisory Committee on Immunization Practices said the combination vaccine, Vaxelis (Merck-Sanofi), should receive a preferential recommendation for American Indian and Alaska Native infants, based on its Haemophilus influenzae type b (Hib) component.
In addition to protecting against Hib, the vaccine provides protection from diphtheria, tetanus, pertussis, polio and hepatitis B (DTaP-IPV-Hib-HepB). It requires two to three fewer shots in the infant vaccination schedule compared with pentavalent combination vaccines, according to Merck.
However, it is not indicated for the Hib booster dose, given between 12 months and 15 months of age. Another vaccine must be used in that instance, according to Jennifer Collins, MD, MSC, a medical epidemiologist at the CDC and the co-lead of the ACIP Hib/Meningococcal Vaccines Work Group.
Before the introduction of Hib vaccines, the disease was a leading cause of bacterial meningitis and other invasive bacterial diseases in the United States, particularly among children 5 years of age and younger, according to Dr. Collins, who provided data for the panel to make its recommendation. With vaccination, invasive Hib disease fell by more than 99%.
Young American Indian and Alaska Native children have a 31-fold higher incidence of invasive Hib disease than non-Native children, Dr. Collins said, so it is important to maintain protection in these groups.
Despite vaccination, “invasive Hib disease does remain a problem in Indian country,” said ex officio member Matthew Clark, MD, FAAP, FACP, the chair of the Indian Health Service (IHS) national Pharmacy and Therapeutics Committee.
Before this vote, the ACIP preferentially recommended PedvaxHIB, made by Merck, because the two-dose primary series induces an antibody response after the first dose.
Data showed that Vaxelis was noninferior to PedvaxHIB for the development of anti-Hib immunoglobulin geometric mean concentrations after one dose, according to Dr. Collins. In addition, the safety profile of Vaxelis was consistent with other licensed combination vaccines, except for Pentacel (Sanofi). There was a higher rate of fever with Vaxelis than Pentacel, according to Dr. Collins.
Post-licensure data from the Vaccine Adverse Event Reporting System, from June 26, 2019 to June 16, 2023, did not show any new or unexpected safety issues, she added. In addition, neither Vaxelis nor PedvaxHIB requires reconstitution, and the shelf life of Vaxelis is four years-one year longer than that of PedvaxHIB.
Also in a unanimous vote, the ACIP approved the recommendation that DTaP-IPV-Hib-HepB vaccine be covered under the Vaccines for Children (VFC) Program. All American Indian/Alaska Native children are eligible to receive vaccinations through this program regardless of where they are vaccinated, Dr. Clark explained. “I can tell you that 100% of American Indian/Alaskan Native infants who receive their care at an IHS tribal, federal or urban facility get their vaccines through the Vaccines for Children program.”
Furthermore, “IHS supports an ACIP preferential recommendation for Vaxelis for American Indian/Alaska Native infants,” Dr. Clark said.
“Given the noninferiority in the immunogenicity study of the post−dose 1 Hib component of Vaxelis compared with PedvaxHIB, the potential durability of protection and the advantages of being able to offer a multivalent vaccine option to reduce total injections and potentially support greater vaccine acceptance among our high-risk American Indian and Alaska Native population, we do feel that this preferential recommendation is warranted,” Dr. Clark noted. ”In addition, since-as I mentioned-all American Indian/Alaska Native infants are covered by the VFC program, IHS also supports a VFC recommendation for Vaxelis.”
He said there is a plan to conduct post-implementation surveillance for invasive Hib disease to look for breakthrough infections.
The ACIP does not make a preferred recommendation for the booster dose.
