Sanofi (SNY)’s MenQuadfi Becomes First MenACWY Vaccine Approved for Ages 6 Weeks and Up

The U.S. FDA has approved an expanded indication for Sanofi (NASDAQ:SNY)’s quadrivalent meningococcal vaccine, MenQuadfi, now allowing its use in children as young as 6 weeks old. Previously approved for individuals aged 2 years and older, MenQuadfi by Sanofi (NASDAQ:SNY) becomes the only MenACWY vaccine available for people from 6 weeks of age with no upper age limit.

The vaccine protects against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W, and Y, a critical step, as infants are at the highest risk for IMD, which can be rapidly fatal.

A closeup of a vial of the biotechnology company’s vaccines.

The new dosing schedule includes a 4-dose series for infants starting at 2, 4, 6, and 12–18 months, and a 2-dose series for those 6–23 months, with a single dose for those 2 years and older. Clinical trials involving over 6,000 participants demonstrated MenQuadfi’s safety and strong immune response, comparable to other licensed vaccines.

Sanofi (NASDAQ:SNY)’s vaccine is supplied as a ready-to-use liquid in single-dose vials, streamlining administration. This expansion comes amid a recent rise in U.S. meningococcal disease cases, particularly serogroup Y, which MenQuadfi covers. The CDC’s Advisory Committee is expected to discuss implementation recommendations next month.

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Disclosure: None.