FDA Approves VAXELIS Combo Vaccine Despite Infant Mortality
Last week, the U.S. Food and Drug Administration (FDA) approved VAXELIS, a new 6-in-1 combo vaccine. The new drug, produced as a collaborative effort by pharmaceutical giants Merck and Sanofi, claims to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b.
The vaccine has been approved for infants as young as 6 weeks old and will be administered in a series of 3 doses between 6 weeks and 4 months of age.
The most frequently reported adverse reactions after Vaxelis administration were irritability, crying, somnolence, injection site reactions
(pain, erythema, swelling) decreased appetite, and vomiting
The safety of Vaxelis in children over 15 months of age has not been studied in clinical trials.