FDA Approves 6 in 1 Combo Vaccine for Babies

On Dec. 21, 2018, the U.S. Food and Drug Administration (FDA) approved a new combination hexavalent vaccine (Vaxelis) that includes antigens for six different diseases: diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive haemophilus influenza type B. Combination vaccines have been created by manufacturers to purportedly reduce the number of shots a child must receive to be in compliance with government recommended childhood vaccine schedules and to simplify ordering, transport and storage of vaccines. Drawbacks to the multivalent vaccines include a higher risk of pain and swelling at the injection site and, and for Merck’s MMRV (mumps, measles, rubella, varicella) vaccine in particular, a higher incidence of febrile seizures in children under age four. The product manufacturer package insert for the new hexavalent vaccine states that Vaxelis is contraindicated in children with a history of severe allergic reaction to any of the ingredients of the vaccine, or to any “other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine.”