MenQuadfi cleared for infants

The FDA has 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. 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 II and III trials. MenQuadfi becomes the only MenACWY vaccine that can help protect for individuals 6 weeks of age and older, with no upper age limit.

"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."

In terms of dosing, for infants aged from 6 weeks, a 4-dose series at 2, 4, 6 and between 12 and 18 months of age. The first dose may be given as early as 6 weeks. For infants 6 months through 23 months, this is a 2-dose series with the second dose administered in the second year of life and at least 3 months after the first dose. For everyone aged 2 years or older, it is 1 vaccine.

MenQuadfi is available as a fully liquid solution that does not require reconstitution and is supplied in a single-dose vial. FDA approval of MenQuadfi for use across a broad age range was based on a robust clinical research program, which demonstrated safety and efficacy of the vaccine from infancy to adulthood,

"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 a Sanofi 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."

Menquadfi clinical development program in infants - In a series of phase III 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. 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. 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.