Update: The CDC director approved this recommendation on June 26.
A federal vaccine committee recommends including Vaxelis as one of two preferred vaccines to protect American Indian/Alaska Native (AI/AN) infants from Haemophilus influenzae type b (Hib).
Experts from the Centers for Disease Control and Prevention (CDC) said the option to use Vaxelis or PedvaxHIB would provide more flexibility and reduce the number of injections needed to complete the childhood immunization series. The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11-0 in favor. If the CDC director signs off on the recommendation, it will be published in the Morbidity and Mortality Weekly Report and added to the CDC’s vaccination resources.
There are five Hib vaccines in the U.S., and they are highly effective in preventing Hib disease. AI/AN children under 5 years have a 31-fold higher incidence of invasive Hib disease than non-Native children, according to the CDC.
For AI/AN infants, PedvaxHIB (polyribosylribitol phosphate-outer membrane protein [PRP-OMP]) is the preferred primary series vaccine because it provides significant protection after the first dose. Before vaccines became available, Hib meningitis tended to peak at an earlier age among AI/AN infants compared to other groups.
Vaxelis, which was licensed in December 2018, also contains PRP-OMP but in a lower dose than PedvaxHIB. Until recently, data on immunogenicity after dose one were not available. Vaxelis also protects against diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B.
The CDC presented new data Wednesday from a clinical trial with AI/AN infants randomized to receive either Vaxelis or PedvaxHIB. It showed anti-Hib antibody concentrations were similar in both groups 30 days after the first dose and higher in the Vaxelis group 150 days after the first dose.
More than 7.4 million doses of Vaxelis have been distributed in the U.S., and its safety in prelicensure trials was consistent with similar vaccines.
CDC experts laid out several benefits to adding a second preferred Hib vaccine option for AI/AN infants, including the potential to improve vaccination rates. Among AI/AN children born in 2020, coverage with a full Hib series by 24 months was 67.5%, and rates are lower than for white children. Because Vaxelis protects against six diseases, its use reduces the number of injections needed to complete the childhood immunization series. The costs of Vaxelis are similar to other vaccine options when including administration costs.
ACIP members agreed the advantages outweigh potential disadvantages such as confusion around vaccine combinations or extra doses of certain antigens. They voted in favor of both Vaxelis and PedvaxHIB being preferential options for the primary series in AI/AN infants. Vaxelis cannot be used as a booster.
Matthew A. Clark, M.D., FAAP, chair of the Indian Health Service (IHS) National Pharmacy and Therapeutics Committee said IHS supports the recommendation.
“Given the noninferiority in the immunogenicity study … 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,” he said.
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