CDC’s Advisory Committee Unanimously Recommends Vaxelis to Prevent Invasive Hemophilus Influenzae Type B in American Indian and Alaska Native Infants

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The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has unanimously voted to add Vaxelis to its preferential recommendations for the treatment of American Indian and Alaska Native infants with invasive Hemophilus influenzae type B (Hib). Developed as a collaboration between Merck and Sanofi, Vaxelis is the only hexavalent combination vaccine available in the United States. Vaxelis could potentially offer the advantage of reducing the number of injections needed in the first year of life compared to other vaccine schedules. Moving forward, the recommendation has the potential to significantly influence vaccine administration strategies and public health policies, especially in high-risk populations.¹

“We are pleased with the ACIP preferential recommendation for Vaxelis in American Indian and Alaska Native infants,” said Thomas Grenier, head, US Vaccines, Sanofi, in a press release. “With Vaxelis, the only hexavalent combination vaccine in the US, health care providers can help prevent invasive Hib disease in these infants while using fewer injections in the first year of life compared to pentavalent and monovalent vaccine schedules. Public health is at the heart of everything we do, and this vote for the preferential recommendation furthers our commitment to ensuring all communities have access to needed vaccines.”

Data supporting the recommendation came from a study conducted by a team of researchers at Johns Hopkins Bloomberg School of Public Health in Navajo Nation and Alaska Native populations, which was led by Laura Hammitt, MD. The HibVas study, which enrolled 333 American Indian and Alaska Native infants, was a Phase IV, prospective, open label, randomized controlled trial, aimed to show that treatment with Vaxelis helped Hib antibody levels in American Indian and Alaska Native infants meet non-inferiority criteria 30 days after one dose compared to PedvaxHIB.^1,2

After 30 days, observed data for Anti-Hib Antibody GMC µg/mL (95% CI) for PedvaxHIB was 0.39 (0.31- 0.50) compared to 0.41 (0.33 - 0.52) for Vaxelis.

Serious adverse events (SAEs) were reported in 21 of the participants, with none coming as a result of the study, according to the investigators. The most common SAE was acute respiratory infection.

Hammitt’s team acknowledged limitations of the study, such as participant follow up ending after seven months. Additionally, over 90% of the participants had anti-Hib antibody above the putative correlate of short-term protection. Further, the proportion of participants with anti-Hib antibody concentrations above the putative correlate of long-term protection and the anti-Hib GMC were greater in the Vaxelis group.²

According to the CDC, Hemophilus influenzae can lead to serious infections that may result in sepsis, long-term problems, or death if a child isn’t vaccinated.³

“American Indian and Alaska Native children have historically had higher rates of invasive Hib disease than the general population, and disease onset often occurs at earlier ages. Until now, only one other available Hib vaccine was preferentially recommended in American Indian and Alaska Native infants. The ACIP vote to include Vaxelis in the preferential recommendation recognizes the data supporting the use of Vaxelis in this population and highlights the importance of research in communities that have a higher risk of certain infectious diseases,” stated Paula Annunziato, MD, SVP, Merck Research Laboratories at Merck, in the press release.

References

1. CDC’s ACIP unanimously votes to add VAXELIS®, Sanofi and Merck’s pediatric hexavalent combination vaccine, to its preferential recommendations to help prevent invasive Hib disease in American Indian and Alaska Native infants. Sanofi. June 26, 2024. Accessed June 28, 2024. https://www.news.sanofi.us/2024-06-27-CDCs-ACIP-unanimously-votes-to-add-VAXELIS-R-,-Sanofi-and-Mercks-pediatric-hexavalent-combination-vaccine,-to-its-preferential-recommendations-to-help-prevent-invasive-Hib-disease-in-American-Indian-and-Alaska-Native-infants

2. The HibVax Study. CDC. Accessed June 28, 2024. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-02-28-29/03-Vaxelis-Hammitt-508.pdf

3. Haemophilus influenzae Disease Symptoms and Complications. CDC. Webpage. Updated March 1, 2024. Accessed June 28, 2024. https://www.cdc.gov/hi-disease/symptoms/index.htm