Vaxelis® Hexavalent Vaccine 2024

Vaxelis® is a pediatric hexavalent (six-in-one) combination vaccine available in the USA (STN: 125563/0) since 2018 and in Europe. The U.S. FDA issued a Supplemental Approval on April 12, 2023 (STN: BL 125563/274), and has posted an updated Package Insert and Patient Information. Vaxelis was developed as part of a partnership established in 1991 between Merck and Sanofi Pasteur and draws upon both companies' experience in developing, manufacturing, and marketing individual and combination vaccines. Vaxelis includes antigens for diphtheria, tetanus, pertussis (whooping cough), and poliomyelitis from Sanofi Pasteur and antigens for Haemophilus influenzae type b and hepatitis B from Merck.

On February 11, 2021, the U.S. Centers for Disease Control and Prevention Advisory Committee (ACIP) included VAXELIS as a combination vaccine option in the Recommended Child and Adolescent Immunization Schedule. Vaxelis is approved for use in children from 6 weeks through 4 years of age (before the 5th birthday). On February 29, 2024, the ACIP committee reviewed - Background on invasive Hib disease and vaccination among American Indian and Alaska Native Populations; The HibVax Study: Immunogenicity of H. influenzae type b PRP-OMP vaccines in American Indian and Alaska Native infants; and Work group considerations.

New Jersey-based Merck, known as MSD outside of the United States and Canada, has been inventing for life for 130 years, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of their mission to save and improve lives. For more information, visit www.merck.com. 

Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Vaxelis Hexavalent Vaccine Indication

Vaxelis is indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. Do not administer VAXELIS to anyone with a history of severe allergic reaction to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine, anyone with a history of encephalopathy within 7sevendays of a pertussis-containing vaccine with no other identifiable cause, or anyone with a history of a progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.

Vaccination with VAXELIS may not protect all individuals. The solicited adverse reactions 0-5 days following any dose were irritability (≥55%), crying (≥45%), injection site pain (≥44%), somnolence (≥40%), injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C (≥19%), injection site swelling (≥18%), and vomiting (≥9%).

Vaxelis Hexavalent Vaccine Dosage

Vaxelis is administered as a 3-dose immunization series as an intramuscular injection at 2, 4, and 6 months of age.

Vaxelis Hexavalent Vaccine News

December 8, 2023 - Social media posts that claimed a new "genetic vaccine" had been added to the national vaccine schedule for children aged 2-6 months were debunked in Australia.

July 6, 2023 - "With around 300,000 babies born every year in Australia and an immunization coverage rate of around 94%, we have aimed to give healthcare professionals an effective vaccine that is easy to prepare and administer," said Dr. Iris Depaz, a representative for Sanofi Australia and New Zealand.

June 1, 2021 - Merck and Sanofi announced 'VAXELIS is the first and only hexavalent (six-in-one) combination vaccine is now available in the U.S. indicated for active immunization to help prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b.

November 23, 2020 - A new study on the usage patterns of pediatric hexavalent vaccines reveals that Sanofi's vaccine "Hexaxim" remains the most administered hexavalent vaccine in the world in 2019 with 62% of volume share.

June 27, 2019 -  The U.S. government's vaccine advisory committee voted unanimously to include all parts of Vaxelis within the Vaccines for Children program. 

December 26, 2018 - The U.S. Food and Drug Administration approved Vaxelis (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) for use in children from 6 weeks through 4 years of age (before the 5th birthday).