Meningococcal Vaccines 2024
There are two types of meningococcal vaccines licensed by the U.S. Food and Drug Administration (FDA): Meningococcal conjugate (MenACWY) and Serogroup B meningococcal (MenB) vaccines. The U.S. Centers for Disease Control and Prevention (CDC) vaccination schedules for adolescents and young adults include a MenACWY vaccine and a separate MenB vaccine (four doses) to protect against meningococcal disease. In 2023, the CDC affirmed that 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 may also receive serogroup B meningococcal vaccine (MenB).
Internationally, the European Medicines Agency (EMA) and the U.K. NHS have approved vaccines such as MenQuadfi and Hib/MenC. The Global Road Map for Defeating Meningitis by 2030 was endorsed by the World Health Assembly and was launched in 2021. According to a research report published in September 2022, the meningococcal vaccine market may reach about U.S. $5.91 billion by 2030.
Quadrivalent Meningococcal Conjugate (MenACWY) Vaccines
According to the CDC, 88.6% of adolescents aged 13–17 had received ≥1 MenACWY dose in 2022.
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 against Neisseria meningitidis serogroup B, which causes invasive diseases. The vaccine was approved for use in 2015 for individuals aged 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 Vaccines
GlobalData projects the collective revenue for pentavalent vaccines to reach approximately $555 million in the U.S. by 2029.
Pfizer Inc.'s PENBRAYA™ (meningococcal groups A, B, C, W, and Y vaccine) is a pentavalent vaccine that combines the components from two meningococcal vaccines, Trumenba® (meningococcal group B vaccine) and Nimenrix® (meningococcal groups A, C, W-135, and Y conjugate vaccine), to help protect against the five most common meningococcal serogroups that cause the majority of M.D. globally. PENBRAYA is administered as a two-dose series given six months apart. On October 25, 2023, Jennifer Collins, MD, MSc, presented a Summary of EtR and proposed recommendations for Pfizer's MenABCWY vaccine.
Serum Institute of India Pvt. Ltd. MenFive® (NmCV-5) is a pentavalent vaccine targeting the A, C, W, Y, and X serogroup. In July 2023, the WHO prequalified MenFive®. Nigeria became the first country in the world to offer the multivalent conjugate vaccine Men5CV, which protects people against five strains (A, C, Y, W, and X) of the meningococcus bacteria that causes meningitis. More than 350 million people in 24 high-risk African countries have received the MenAfriVac vaccine since 2010. In September 2023. the WHO's SAGE then advised all countries in the meningitis belt to introduce the new vaccine, which it described as Men5CV, into their routine immunization programs.
GSK's MenABCWY vaccine candidate preliminary results from the phase III trial show all primary endpoints met, demonstrating statistical non-inferiority. This vaccine combines 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. GSK confirmed on April 16, 2024, that the FDA's Prescription Drug User Fee Act action date for a regulatory decision is February 14, 2025.
