FDA clears Menactra for infants
The FDA has expanded the indication of Sanofi-Aventis' Menactra to include a two-dose schedule for infants and children 9 months through 23 months of age, marking the first time a meningococcal vaccine has been approved by the FDA for infants. Meningitis is a rare but deadly disease that can kill children within 24 hours. Menactra was first approved in 2005 for 11 to 55-year-olds; the indication was later expanded to include children aged 2 years and up.
Results from mid- and late-stage trials involving 3,300 infants showed that administering the two-dose vaccine, first at 9 months and later at 12 months, elicited a strong immune response in infants. The serogroups contained in the vaccine include A, C, Y and W-135. According to the company's release, studies also showed that measles-mumps-rubella-varicella and pneumococcal conjugate vaccine can be administered at the same time as Menactra.
"The approval of Menactra vaccine for infants is a significant advancement toward potentially eliminating the threat of this serious disease in this vulnerable population for included serogroups," said Sanofi Pasteur VP Michael Decker. "Licensure of Menactra vaccine for infants as young as nine months of age gives the opportunity to help protect infants against this potentially deadly disease when the likelihood of exposure supports a need for early protection," added Stephen Pelton of the Boston University School of Medicine.
- here's the release for more