Advice for the use of the Multicomponent Meningococcal Serogroup B (4CMenB) Vaccine

What is invasive meningococcal disease?

Invasive meningococcal disease (IMD) usually presents as an acute febrile illness with rapid onset and features of meningitis or septicemia (meningococcemia), or both, and a characteristic non-blanching rash. Overall case fatality is approximately 10%, and up to a third of survivors may have long term sequelae, which include hearing loss, neurologic disabilities, and digit or limb amputations. In 2011, 108 of 175 (62%) reported cases of IMD in Canada were due to serogroup B; 18.5% of serogroup B IMD cases were infants, the majority less than 6 months of age. The rates of IMD from other serogroups have been decreasing since the introduction of routine vaccination programs. Additional information about IMD is available on the Public Health Agency of Canada (the Agency) web site.

What is the multicomponent meningococcal serogroup B vaccine (4CMenB)?

The multicomponent meningococcal serogroup B (4CMenB) vaccine is the first available vaccine against serogroup B IMD in Canada. The vaccine is protective against strains that express antigens contained in the vaccine at sufficient levels. The 4CMenB vaccine is an immunogenic vaccine, though its effectiveness, impact on carriage and the duration of protection remains unknown. Further research, evaluation and surveillance will be required to determine the duration of protection, the efficacy or effectiveness of 4CMenB vaccine, its ability to induce herd protection, and the risk of adverse events with widespread use.

Whom to immunize?

Individuals greater than or equal to two months of age:

• who are at high risk of meningococcal disease caused by serogroup B Neisseria meningitidis
• that have been in close contact with a case of IMD caused by serogroup B N. meningitidis
• who may be at risk during IMD outbreaks caused by serogroup B N. meningitidis or the emergence of hyperendemic and/or hypervirulent N. meningitidis strains that are predicted to be susceptible to the vaccine based on Meningococcal Antigen Typing System (MATS) testing

Dose, schedule and precautions, and co-administration

Vaccine schedules vary with age at administration. Because of unknown duration of protection after immunization, the need for a booster dose is yet to be determined.

4CMenB vaccine has been given simultaneously with a hexavalent tetanus diphtheria containing infant vaccine, heptavalent pneumococcal conjugate vaccine (PCV7), serogroup C meningococcal vaccine and MMRV. High rates of fever have been observed, particularly with simultaneous administration of 4CMenB vaccine and routine infant vaccines. The immune response to routine infant vaccines and the 4CMenB vaccine does not appear to be affected when these vaccines are administered simultaneously.

4CMenB vaccine is contraindicated in persons with a serious allergy to any vaccine component or previous dose. There are no studies of 4CMenB vaccine in pregnant or lactating women, persons less than 2 months and over 55 years of age, persons with a chronic medical condition and those with previous meningococcal infection.

4CMenB should be stored at +2 to +8°C and should not be frozen.

Why immunize?

To prevent IMD caused by serogroup B meningococcal strains against which the vaccine may be effective.