The FDA has approved expanded use of Sanofi Pasteur’s MenQuadfi, a meningococcal conjugate vaccine for children aged 2 to 10.
MenQuadfi is now the first quadrivalent conjugate vaccine licensed in the U.S. to prevent meningococcal disease in this age group, according to a news release from the agency.
Originally approved in 2005 for individuals aged 11 to 55, the vaccine protects against four major serogroups: A, C, Y and W-135.
The FDA’s decision was supported by two large clinical trials demonstrating the vaccine’s safety and immunogenicity in younger children. The studies also showed stronger immune responses compared to Menomune, a polysaccharide vaccine.
The expanded approval comes amid ongoing concern over meningococcal disease, a rapidly progressing bacterial infection that affects up to 2,800 people in the U.S. each year, according to the release.
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