FDA approves MenQuadfi meningococcal vaccine for children 6 weeks or older | Image credit: Contemporary Pediatrics

On May 23, 2025, the FDA approved an expanded indication of Sanofi's quadrivalent meningococcal vaccine MenQuadfi—for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W, and Y—to include children aged 6 weeks to 23 months.^1,2

MenQuadfi was first approved by the FDA on April 23, 2020, for individuals aged 2 years and older, based on results from 5 double-blind, randomized, multicenter phase 2 and 3 trials.^3,4

"We know that over the last couple of years, there has been a significant increase in the amount of meningococcal disease that's being seen here in the United States," Tina Tan, MD, FIDSA, FPIDS, FAAP, editor in chief, Contemporary Pediatrics; president, Infectious Diseases Society of America (IDSA), told Contemporary Pediatrics in an interview. Tan is also the Infectious Diseases attending at Ann & Robert H. Lurie Children's Hospital of Chicago, and professor of Pediatrics at Northwestern University's Feinberg School of Medicine.

"The majority of disease seen now is serotype Y, which this vaccine contains. Individuals at the highest risk are young infants, in addition to individuals like college students, people in military barracks, or teenagers who have other risk factors for disease," said Tan. "These younger individuals are at much higher risk of getting disease and having complications. This is not something that is new, because there are many countries that have recommendations to give a meningococcal vaccine to the younger pediatric population to protect them."

A Sanofi spokesperson told our sister publication Contagion, because this decision by the FDA is an expansion, health care providers can start using the vaccine in infants aged 6 weeks or older, however, direct implementation depends on other factors.⁵

"It is anticipated that the Centers for Disease Control and Prevention (CDC) Advisory Committee of Immunization Practices (ACIP) will vote on the use of MenQuadfi in infants and toddlers 6 weeks through 23 months of age during the ACIP meeting scheduled for next month, in June 2025," stated the spokesperson.

In some situations where individuals are at increased risk for meningococcal disease, the CDC recommends that individuals aged 2 months or older receive a vaccine, followed by regular booster doses if they remain at increased risk.⁶

"IMD remains a major global health challenge because it can strike quickly and with devastating effects, potentially taking a life in less than 24 hours," said the spokesperson. "Now, MenQuadfi becomes the only MenACWY vaccine that can help protect individuals 6 weeks of age and older, with no upper age limit," and is "available as a fully liquid solution that does not require reconstitution and is supplied in a single-dose vial."⁵

Menquadfi clinical development program in infants

In a series of phase 3 clinical trials that featured 4321 infants who ranged in age from 9 weeks to 19 months, of which 1717 infants received the MenACWY-CRM or MenACWY-D comparator vaccines, the post-dose 4 seroresponse for MenQuadfi was similar to comparator vaccines.⁷

Immunogenicity results demonstrated non-inferior immune responses, administered with routine pediatric vaccines, compared to currently licensed MenACWY conjugate vaccines. Additionally, there were no unexpected safety concerns found in infants and toddlers aged 6 weeks to 23 months compared to the safety profile among individuals aged 2 years or older with other licensed MenACWY conjugate vaccines.³

The safety profile of 237 infants with a history of preterm birth (31-36 weeks gestational age) was comparable to infants who had been born full-term, with no new safety concerns or AEs leading to study discontinuation, according to Sanofi.

This article is part one of a series highlighting the FDA expanded approval of MenQuadfi. Click here for the second part.

References:

1. Sunny ME, Mahatole S. US FDA approves use of Sanofi's meningococcal vaccine in infants. Reuters. May 27, 2025. Accessed May 27, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-use-sanofis-meningococcal-vaccine-infants-2025-05-27/

2. Sanofi Q3: 15.7% sales growth boosted by earlier-than-anticipated vaccine sales; 2024 business EPS guidance raised due to strong business performance. Sanofi. Press release. October 25, 2024. Accessed May 22, 2025. https://www.sanofi.com/assets/dotcom/pressreleases/2024/2024-10-25-05-30-00-2969234-en.pdf

3. Meningococcal (Groups A, C, Y, and W) Conjugate Vaccine (MenQuadfi) extension of use to include infants from 6 weeks of age. Sanofi. Accessed May 22, 2025. https://www.cdc.gov/acip/downloads/slides-2025-04-15-16/05-Dawson-Mening-508.pdf

4. FDA approves Sanofi’s meningococcal conjugate vaccine. Contemporary Pediatrics. April 28, 2020. Accessed May 22, 2025.

5. Parkinson, J. FDA approves an expanded indication for meningococcal vaccine for youngest pediatric population. Contagion. May 27, 2025. Accessed May 27, 2025. https://www.contagionlive.com/view/fda-approves-an-expanded-indication-for-meningococcal-vaccine-for-youngest-pediatric-population

6. Meningococcal vaccine recommendations. CDC. October 24, 2024. Accessed May 27, 2025. https://www.cdc.gov/meningococcal/hcp/vaccine-recommendations/index.html

7. Schillie S. Work Group Considerations Regarding MenQuadfi in Infants. ACIP. April 16, 2025. Accessed May 27, 2025. https://www.cdc.gov/acip/downloads/slides-2025-04-15-16/06-Schillie-mening-508.pdf