Sanofi’s MenQuadfi approved in EU for infants from six weeks of age

Regulation
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The European Commission has approved Sanofi’s MenQuadfi vaccine for use in infants aged six weeks and older, expanding protection against invasive meningococcal disease caused by serogroups A, C, W and Y. MenQuadfi was previously authorized in the EU only for individuals 12 months and older, and the new indication introduces infant dosing schedules aligned with routine pediatric immunization programs. The approval is supported by the MET58 pivotal study, which evaluated immunogenicity, safety and tolerability in more than 6,000 infants across 11 countries. The decision broadens Sanofi’s vaccine portfolio and gives healthcare providers an additional option to protect infants against a rapidly progressing disease associated with high mortality and long-term complications.

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EU approval expands MenQuadfi to infants, broadening market and potential uptake.

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