Meningococcal Vaccines 2023

There are two types of meningococcal vaccines licensed by the U.S. Food and Drug Administration (FDA): Meningococcal conjugate (MenACWY) vaccines and Serogroup B meningococcal (MenB) vaccines. The U.S. Centers for Disease Control and Prevention (CDC) 2023 vaccination schedules for adolescents and young adults include a MenACWY vaccine and a separate MenB vaccine (four doses) to protect against meningococcal disease. According to the CDC, 88.6% of adolescents aged 13–17 had received ≥1 MenACWY dose in 2022. The World Health Organization's (WHO) goal is to eliminate bacterial meningitis epidemics by 2030, and other targets are set out in its Defeating Meningitis roadmap. In July 2023, the WHO prequalified MenFive®, a conjugate vaccine that protects people against the five causes of meningococcal meningitis in Africa.

Meningococcal Vaccines U.S. CDC

In August 2023, the CDC affirmed a booster dose of MenACWY is recommended at the age of 16 years, and using shared clinical decision-making, adolescents and young adults aged 16–23 years may also receive serogroup B meningococcal vaccine (MenB). The U.S. CDC's ACIP Meningococcal Vaccine meeting on February 23, 2023, included Introduction, Dr. Kathy Poehling; Epidemiology of meningococcal disease in the U.S., Ms. Amy Rubis; Pfizer pentavalent meningococcal vaccine, Dr. Jason Maguire; Workgroup considerations, Dr. Sam Crowe. The ACIP Meningococcal Vaccines Work Group meeting on October 20, 2022, led by Katherine Poehling, MD, MPH Work Group Chair, presented an overview and Plan for Assessing the MenABCWY Vaccines.

Quadrivalent Meningococcal Conjugate (MenACWY) Vaccines

Menactra vaccine is for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Menactra vaccine is approved for use in persons nine months through 55.

Menveo® vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Menveo is approved for use in persons two months through 55.

MenQuadfi® vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi is approved for use in individuals two years of age and older.

Serogroup B Meningococcal (MenB) Vaccines

Trumenba vaccine is for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for individuals 10-25 years of age.

Bexsero® is a vaccine to prevent invasive diseases caused by Neisseria meningitidis serogroup B. Bexsero was approved for use in 2015 for individuals 10 through 25. 

Two additional licensed meningococcal vaccines are no longer available in the United States: 1) a quadrivalent (serogroups A, C, W, and Y) meningococcal polysaccharide vaccine (MPSV4) (Menomune – A/C/Y/W-135) and 2) a combined Haemophilus influenzae type b and meningococcal serogroups C and Y conjugate vaccine (Hib-MenCY-TT) (MenHibrix).

Meningococcal Pentavalent Vaccine Candidates 2023

Pfizer's investigational pentavalent meningococcal vaccine (MenABCWY) candidate is conducting a phase 3 clinical trial. Jason D. Maguire, MD, MPH Clinical Lead, Phase 3 Program Pfizer Vaccines Clinical R&D, presented an update on February 23, 2023.

GSK's MenABCWY vaccine candidate preliminary results from the phase III trial show all primary endpoints met, demonstrating statistical non-inferiority compared to Bexsero (meningococcal group B vaccine) and Menveo (meningococcal group A, C, W-135, and Y conjugate vaccine), in individuals 10-25 years old with an acceptable safety profile.

Serum Institute of India Pvt. Ltd. MenFive® (NmCV-5) is a pentavalent vaccine targeting the A, C, W, Y, and X serogroup. A study published on May 25, 2023, found all four serotypes in common with the MenACWY-D vaccine, the NmCV-5 vaccine-elicited immune responses that were noninferior to those elicited by the MenACWY-D vaccine. In the phase 3 clinical trial, NmCV-5 elicited immune responses to serogroup X. No safety concerns were evident.

Meningococcal Vaccine Market Size

According to a Comprehensive Research Report published on September 7, 2022, the Meningococcal Vaccines Market may reach about U.S. $5.91 billion by 2030.

Meningitis Outbreaks

More than 350 million people in 24 high-risk African countries have received the MenAfriVac vaccine since 2010. Together, five serogroups (A, B, C, W, and Y) account for 96% of all invasive meningococcal disease cases worldwide, with serogroup B accounting for most diseases in adolescents and young adults in the U.S. and Europe, reports the U.S. NIH. The WHO Africa and its partners announced on September 6, 2022, that they have launched a roadmap to stop bacterial meningitis outbreaks by 2030. However, as of April 2023, Nigeria reported a fatal epidemic.

Meningococcal Vaccine News 2023

March 16, 2023 - GSK plc confirmed positive results from a phase 3 clinical trial evaluating its MenABCWY combination vaccine candidate. All primary endpoints were met, including the non-inferiority of the vaccine candidate for all five Neisseria meningitides serogroups (A, B, C, W, and Y) compared to licensed meningococcal vaccines Bexsero and Menveo in terms of an immune response. In addition, the vaccine candidate was well tolerated, with a safety profile consistent with Bexsero and Menveo.

February 2, 2023 - Results from a matched case-control study into four-component, protein-based meningococcal serogroup B (4CMenB) effectively prevented invasive disease by serogroup B and non–serogroup B meningococci in children younger than five years of age.

December 28, 2022 - The U.S. FDA approved the Biologics License Application for Pfizer's Investigational Pentavalent Meningococcal Vaccine Candidate (MenABCWY) in Adolescent for review.

September 15, 2022 - Pfizer Inc. announced positive top-line results from the pivotal Phase 3 trial assessing the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10 through 25 years of age. The trial met all primary and secondary endpoints. In addition, the investigational vaccine demonstrated non-inferiority to licensed vaccines for the five meningococcal serogroups that cause the most invasive meningococcal disease: serogroups A, B, C, W, and Y.