FDA Approves Menveo Single-Vial Presentation for Disease Caused by Meningococcal Bacteria

The FDA has approved a new single-vial presentation of GSK’sMeningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diptheria CRM197 Conjugate vaccine (Menveo) for individuals 10 to 55 years of age for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, Y, and W.

In 2010, the FDA approved the original 2-vial presentation of the vaccine, which required reconstitution. The 2-vial presentation will remain available for use in individuals from 2 months to 55 years of age. The new presentation offers health care providers with a more convenient, ready-to-use immunization option, according to GSK, who added in a press release that the single-vial presentation will initially be available in the United States with more widespread availability expected by mid-2023.

“Outbreaks of this dangerous disease continue to occur, impacting families, health systems and society,” said Roger Connor, president, Vaccines and Global Health, GSK, in a press release. “This FDA approval of Menveo 1-vial presentation offers greater convenience to health care providers to help prevent this disease in at-risk populations in the United States.”

IMD, also known as meningitis, is an uncommon but serious illness that can lead to life-threatening complications and death. One in every 10 patients who contract meningitis will die even with treatment, sometimes in as few as 24 hours, according to GSK. Further, 1 in 5 patients who survive meningitis experience long-term consequences, including brain damage, amputations, hearing loss, and nervous system issues.

The 2-vial presentation of the Menveo vaccine for meningococcal groups A, C, Y, and W is approved in more than 60 countries, with over 72 million doses distributed worldwide since 2010, according to GSK. Menveo has shown significant evidence of immunogenicity as well as a well-characterized safety profile. The vaccine does not prevent Neisseria meningitidis serogroup B infections.

The most common adverse events (AEs) among children administered the 4-dose series of Menveo at 2 months of age were injection site tenderness and erythema, irritability, sleepiness, persistent crying, changing eating habits, vomiting, and diarrhea. The most common AEs among those administered the 2-dose series from 7 months through 23 months of age were injection site tenderness and erythema, irritability, sleepiness, persistent crying, changing eating habits, and diarrhea. The most common AEs in those 2 through 10 years of age administered the vaccine were injection site pain, erythema, irritability, induration, sleepiness, malaise, and headache.

The most common solicited AEs among individuals 11 through 55 years of age administered a single dose of Menveo were injection site pain, headache, myalgia, malaise, and nausea. Across all of the age groups, there were some severe AEs. Similar rates of solicited AEs among adolescents and adults were seen after a single-booster dose.

Menveo should not be administered to individuals with a severe allergic reaction, such as anaphylaxis to a prior dose of the vaccine, to any component of the vaccine, or to any other vaccine containing diphtheria toxoid.

A pair of clinical studies found no notable differences in the frequency and severity of solicited AE among those administered the Menveo single-vial presentation vs those administered the 2-vial presentation.

Vaccination with Menveo may not confer protection among all recipients, according to GSK.

Reference

US FDA approves Menveo in a new single-vial presentation to help prevent disease caused by meningococcal bacteria serogroups A, C, Y, and W. GSK. News release. October 17, 2022. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-menveo-in-a-new-single-vial-presentation-to-help-prevent-disease-caused-by-meningococcal-bacteria-serogroups-a-c-y-and-w/