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Six-in-One Pediatric Combination Vaccine Now Available in the United States

This Combination Vaccine May Simplify Execution and Reduce Shots Needed to Complete CDC’s Recommended Child and Adolescent Immunization Schedule

VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine), developed as part of a U.S.-based partnership between Merck, known as MSD outside the United States and Canada, and Sanofi Pasteur, the global vaccines business unit of Sanofi, is now available in the U.S. VAXELIS is the first and only hexavalent (six-in-one) combination vaccine 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. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).

Given the potential to reduce the number of shots by as many as three in the first six months of life, as compared to pentavalent vaccines plus hepatitis B or Haemophilus influenzae type b vaccines, VAXELIS represents an important option for healthcare professionals and parents, – said Joanne Monahan, senior vice president, U.S. Vaccines, Merck.  – Merck and Sanofi have been in contact with the major insurers and the appropriate pricing publications to notify them of the availability of VAXELIS, and we look forward to working with payers and providers to deliver this novel hexavalent vaccine to age-appropriate children. This news should also help to remind providers and parents of the importance of continuing routine vaccinations and recommended well visits.

On February 11, 2021, the U.S. Centers for Disease Control and Prevention’s Advisory Committee included VAXELIS as a combination vaccine option in the CDC’s Recommended Child and Adolescent Immunization Schedule. VAXELIS will be widely available in the U.S. through traditional public and private channels, including directly from Sanofi Pasteur via

As the first six-in-one vaccine in the U.S., VAXELIS is now available to help protect infants and children against diseases caused by six infectious agents. We are proud to offer this vaccine to healthcare professionals and the patients they serve, – said Elaine O’Hara, Head of Sanofi Pasteur Commercial Operations North America. – Studies have shown that combination vaccines may help increase vaccination compliance and reduce disease burden by improving vaccine timeliness and coverage rates.

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 7 days of a pertussis-containing vaccine with no other identifiable cause, or anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.

About Combination Vaccines

Combination vaccines take two or more vaccines that could be given individually and put them into a single shot. Combination vaccines have been a significant catalyst for change for the healthcare industry since their introduction more than 50 years ago. Public health authorities and leading professional associations generally recommend the use of combination vaccines over separate injections, when appropriate, including the American Academy of Pediatrics, The American Academy of Family Physicians, U.S. Centers for Disease Control and Prevention, The World Health Organization and others.


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