Vaxelis™ (diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, Haemophilus b conjugate and hepatitis B vaccine) is now available in the US.
Vaxelis is the first hexavalent combination vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. The vaccine is approved for use as a 3-dose series in children from 6 weeks through 4 years of age (prior to the 5th birthday). The 3-dose series consists of a 0.5mL intramuscular injection administered at 2, 4, and 6 months of age.
Vaxelis has been included as a combination vaccine option in the Centers for Disease Control and Prevention’s (CDC) recommended 2021 Child and Adolescent Immunization Schedule. Three doses of Vaxelis constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease and poliomyelitis; however, the 3-dose series does not constitute a primary immunization series against pertussis as an additional dose of pertussis-containing vaccine is needed to complete the primary series. Vaxelis may be used to complete the hepatitis B immunization series.
Vaxelis is contraindicated in patients with a history of a severe allergic reaction to any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine. It should not be administered to patients with a history of encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine or to those with a history of progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy until a treatment regimen is established and the condition is stabilized.
“As the first 6-in-1 vaccine in the US, Vaxelis is now available to help protect infants and children against diseases caused by 6 infectious agents,” said Elaine O’Hara, Head of Sanofi Pasteur Commercial Operations North America. “Studies have shown that combination vaccines may help reduce the shot burden and improve coverage rates and timeliness.”
Vaxelis is supplied as a suspension for injection (0.5mL dose) in single-dose vials and prefilled syringes.
- Sanofi and Merck’s first and only six-in-one pediatric combination vaccine now available in the United States. [press release]. Bridgewater, NJ and Kenilworth, NJ: Sanofi and Merck; June 1, 2021.
- Vaxelis [package insert]. Whitehouse Stations, NJ and Swiftwater, PA: Merck & Co., Inc. and Sanofi Pasteur, Inc.; 2020.