Quadrivalent Meningococcal Vaccine Receives FDA Approval for Infants and Children With Meningococcal Disease

The FDA has approved an expanded indication of the quadrivalent meningococcal vaccine (MenQuadfi; Sanofi Pasteur Inc.) for the prevention of invasive meningococcal disease in children aged 6 weeks to 23 months.¹

Image credit: Alexey Novikov | stock.adobe.com

“Meningococcal meningitis remains a major global health challenge because it can strike quickly and with devastating effect, taking a life in less than 24 hours,” David Loew, executive vice president of Sanofi Pasteur, said in a news release.²

MenQuadfi is indicated as a single 0.5 mL injection administered intramuscularly for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.¹ Neisseria meningitidis are bacteria that live in the back of the nose or throat, which could sometimes move to other parts of the body and cause infection.³

The current dosing for infants aged from 6 weeks includes a 4-dose series at 2, 4, 6, and between 12 and 18 months of age. A 2-dose series with the second dose is administered in the second year of life and at least 3 months after the first dose for infants 6 months through 23 months.4

Meningococcal Disease Severity

According to the CDC, meningococcal bacteria spread through sharing respiratory and throat secretions through close or lengthy contact, such as kissing or living together. The 2 most common types of meningococcal infections are meningitis and bloodstream infections, which cause swelling to the lining of the brain and spinal cord, along with bleeding in the skin and organs, respectively.² Symptoms of meningococcal meningitis include fever, stiff neck, headache, confusion, increased sensitivity to light, nausea, and vomiting. However, babies usually do not present the typical symptoms and often experience vomiting, abnormal reflexes, a bulging anterior fontanelle, poor feeding, and irritability, and they appear slow or inactive.⁵

“Given the severity and unpredictability of meningococcal disease, there is a public health need to ensure immunization across multiple ages, consistent with U.S. recommendations,” Corey Robertson, head of scientific and medical affairs at Sanofi Pasteur, said in a news release.⁶

MenQuadfi Indications

MenQuadfi is marked as the first and only quadrivalent meningococcal vaccine in the US that uses tetanus toxoid as a protein carrier. Additionally, MenQuadfi is the only FDA-approved quadrivalent meningococcal vaccine indicated for individuals aged 2 through 56 years.⁴

Previous FDA Approval

MenQuadfi was previously approved by the FDA in April 2020 for the prevention of invasive meningococcal disease in individuals aged 2 years and older based on data from 5 double-blind, randomized, multicenter phase 2 and 3 trials. The studies evaluated the vaccines' safety and immune responses in nearly 5000 individuals aged 2 and older. The vaccine demonstrated non-inferiority in immune responses compared to other licensed quadrivalent meningococcal vaccines. Additionally, 4 of the studies involved individuals who had not previously received a meningococcal vaccine, while the fifth study included those who had been previously immunized.²

In individuals new to meningococcal vaccination, 55.4% to 97.2% showed a vaccine-induced immune response against each of the 4 meningococcal serogroups (A, C, W, Y) 30 days post-vaccination. For adolescents and adults who had been previously vaccinated, 92.2% to 98.2% developed an immune response against each serogroup.²

The most common adverse events after the first dose included injection site pain, muscle ache, headache, and tiredness.²

“MenQuadfi’s pivotal clinical trials demonstrated a high immune response across all four serogroups and provide a new vaccine option to help protect an expanded age group,” Roberton said in a news release.³

REFERENCES

1. U.S. Food and Drug Administration. Published April 2020. Accessed May 23, 2025. Vyepti (eptinezumab-jjmr) injection, for intravenous use. https://www.fda.gov/media/137306/download

2. FDA approves MenQuadfiTM, the latest innovation in meningococcal (MenACWY) vaccination. Sanofi. News release. April 24, 2020. Accessed May 28, 2025. https://www.sanofi.com/en/media-room/press-releases/2020/2020-04-24-05-00-00-2021445

3. About Meningococcal Disease. CDC. News release. February 1, 2024. Accessed May 23, 2025. https://www.cdc.gov/meningococcal/about/index.html#:~:text=With%20meningococcal%20meningitis%2C%20the%20bacteria,in%20the%20skin%20and%20organs.

4. Meningococcal (Groups A, C, Y, andW) Conjugate Vaccine (MenQuadfi®) Extension of use to include infants from 6 weeks of age. Sanofi presentation to CDC. April 15, 2025. Accessed May 28, 2025.

5. Meningococcal Disease Symptoms and Complications. August 30, 2024. Accessed May 23, 2025. https://www.cdc.gov/meningococcal/symptoms/index.html

6. FDA Approves Sanofi’s Meningococcal Meningitis Vaccine. BioSpace. News release. April 24, 2020. Accessed May 28, 2025. https://www.biospace.com/fda-approves-sanofi-s-meningococcal-meningitis-vaccine