Tina Tan, MD, comments on FDA expanded approval for MenQuadfi meningococcal disease vaccine
"These younger individuals are at much higher risk of getting disease and having complications," said Tina Tan, MD, FIDSA, FPIDS, FAAP.
Last week, the FDA approved an expanded indication for Sanofi's MenQuadfi meningococcal vaccine—for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W, and Y—that now includes children aged 6 weeks to 23 months. The approval expanded on the previous indication for individuals aged 2 years or older.
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.2
"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 the brief video above, Tina Tan, MD, FIDSA, FPIDS, FAAP, editor in chief, Contemporary Pediatrics; president, Infectious Diseases Society of America (IDSA), provided comments on the expanded approval.
"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," said Tan. "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. 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."
This video interview is the second part of a series highlighting the FDA approval of MenQuadfi. Click here for the fully-detailed article of the approval, including additional comments and clinical trial safety data.
References:
1. Fitch, J. FDA approves MenQuadfi meningococcal vaccine for children 6 weeks or older. Contemporary Pediatrics. May 27, 2025. Accessed May 27, 2025. https://www.contemporarypediatrics.com/view/fda-approves-menquadfi-meningococcal-vaccine-for-children-6-weeks-or-older
2. 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
