FDA Approves MenABCWY Vaccine for Patients Ages 10 to 25 Years
The combination includes 2 previously approved vaccines to target the 5 major serogroups of Neisseria meningitidis.
The FDA approved a vaccine (Penmenvy) for meningococcal groups A, B, C, W, and Y for use in patients 10 to 25 years old. The vaccine targets the 5 major serogroups of Neisseria meningitidis, which causes invasive meningococcal disease (IMD).1
The CDC Advisory Committee on Immunization Practices is expected to vote on the recommendation for the use of this vaccine in adolescents and young adults. | Image Credit: REDPIXEL | stock.adobe.com
“The consequences of IMD can be devastating for those who contract it, for their families and friends,” Judy Klein, president and founder of Unity Consortium, said in a news release.1 "We welcome new tools to help protect more adolescents from meningococcal disease. Pentavalent MenABCWY vaccines could help address the disease by providing protection against the five vaccine-preventable serogroups in one vaccine and making it easier for adolescents to get the coverage they need."
The vaccine combines 2 of GSK’s meningococcal vaccines, and the application for Penmenvy was supported by positive results from 2 phase 3 trials (NCT04502693; NCT04707391). The trials evaluated the vaccine’s safety, tolerability, and immune response in over 4800 patients aged 10 to 25 years.1
In one trial (NCT04502693), investigators evaluated the effectiveness of 2 or 3 doses of the meningococcal group B Bexsero vaccine and 2 doses of Penmenvy in healthy adolescents and young adults. There were 3651 individuals included, with primary end points including safety and breadth of immune response against the MenB strain and percentage of participants whose postvaccination sera kill 70% or more strains, according to the study authors.2,3
Investigators found that the breadth of immune responses was 78.7% for the 0-to-2-month schedule, 81.8% for the 0-to-6-month schedule, and 83.2% for the 0 to 2-to-6-month schedule. There were no clinically relevant differences for immunogenicity, and the schedules were well tolerated, according to the study.3
In the other study (NCT04707391), investigators studied the immunogenicity and safety of the vaccine in patients aged 15 to 25 years that were previously vaccinated with MenACWY. The primary end point included the noninferiority of MenABCWY 1 month after vaccination compared with 1 MenACWY-CRM197-glycoconjugate vaccine as well as to evaluate safety. The secondary end point included the percentage of individuals with human serum bactericidal antibody (hSBA) titers greater than or equal to the lower limit of quantification (≥ LLOQ) against serogroups of ACWY, according to the study authors.4
Investigators found that there was noninferiority of MenABCWY, with the percentages of patients with hSBA titers ≥ LLOQ for serotypes ACWY being 97.9% to 98.9% and 99.5% to 100% following 1 and 2 doses of the MenABCWY doses, respectively. Further, the MenACWY-CRM dose reached percentages of 96.8% to 99%. The vaccine was also well tolerated, according to the findings.4
The CDC Advisory Committee on Immunization Practices is expected to vote on the recommendation for the use of this vaccine in adolescents and young adults.1
READ MORE: Respiratory Resource Center
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