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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Detailed conditionsAn eligibility condition of three months employment by the closing date of the offer period will apply. Eligible staff will be able to subscribe for shares from June 10, 2025 (inclusive) to June 30, 2025 (inclusive). The issue is expected to be completed and the delivery of the securities carried out by the end of July number of shares offered is limited to 1% of Sanofi's share capital as of January 29, 2025, reduced by the impact of the capital increase reserved to employees carried out in July 2024 (i.e., 10,386,831 shares). The new shares, including the matching shares (the "Shares"), will be subscribed (or delivered) either directly or through the intermediary of employee mutual funds ("FCPE"), depending on the regulations and/or tax regime applicable in the various countries of residence of those eligible for the capital increase. 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Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | Léa Ubaldi | + 33 6 30 19 66 46 | Léo Le Bourhis | + 33 6 75 06 43 81| Rouault | + 33 6 70 93 71 40 | Berland | +1 215 432 0234 | Gilbert | + 1 516 521 2929 | Investor RelationsThomas Kudsk Larsen |+ 44 7545 513 693 | Kaisserian | + 33 6 47 04 12 11 | Lauscher | + 1 908 612 7239 | Browne | + 1 781 249 1766 | Pham | + 33 7 85 93 30 17 | Elgoutni | + 1 617 710 3587 | Châtelet | + 33 6 80 80 89 90 | Yun Li | + 33 6 84 00 90 72 | Shares held by the employees according to article L.225-102 of the French Commercial Code 2 For employees subscribing under the PEG: The allocation of all or part of the amount of profit-sharing arrangement (participation and or intéressement) and the transfer of available assets from the FCPE 'PEG Sanofi Monétaire' of the PEG must comply only with the limit of 1,500 shares. 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