A vaccine made by joint effort of Merck and Sanofi Pasteur, the vaccines unit of Sanofi, Vaxelis – for children younger than 5 – got the US FDA’s approval for six active immunization indications.
Vaxelis is a vaccine indicated for active immunization to 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). It may be used to complete the hepatitis B immunization series.
The safety of Vaxelis was evaluated in 6 clinical studies, in which a total of 5,251 infants 43 to 99 days of age at enrollment received at least 1 dose of Vaxelis. The effectiveness of VAXELIS is based on the immunogenicity of the individual antigens compared to US licensed vaccines.
The companies announcing the FDA’s approval noted that commercial supply will not be available in the U.S. prior to 2020.