Quadrivalent Meningococcal Conjugate Vaccines
In 2005, the first quadrivalent meningococcal conjugate vaccine conjugated to diphtheria toxin was licensed by the US Food and Drug Administration. A second MenACWY vaccine conjugated to CRM-197 was licensed in 2010 and Nemenrix by GSK was licensed in 2012. In pre-licensure clinical studies, all these vaccines were found to be safe and immunogenic. In the United States these vaccines are licensed for the age 254 years, with studies evaluating a multiple dose series in infants and toddlers ongoing.
Meningococcal Vaccine: Canadian Immunization Guide
For health professionals
Latest partial content update :
: The chapter has been updated to align with the National Advisory Committee on Immunization Statement : The Use of Bivalent Factor H Binding Protein Meningococcal Serogroup B Vaccine for the Prevention of Meningococcal B Disease.
MenB-fHBP vaccine may be considered as an option for use in individuals 10 years of age and older in situations when a serogroup B meningococcal vaccine should be offered:
MenB-fHBP vaccine may be considered as an option for individuals 1025 years of age who are not at higher risk of meningococcal disease than the general population, but who wish to reduce their risk of invasive serogroup B meningococcal disease.
Last complete chapter revision: May 2015
What Is Meningococcal Disease And What Are The Complications Of This Disease
Invasive meningococcal disease is caused by a bacteria called Neisseria meningitidis . There are many different groups or types of this bacteria that can cause disease. Each type is identified by a letter. The bacteria can cause infection of joints , blood , the lining of the heart , the lung , or the brain .
The most common illness caused by this bacteria is meningitis and, since 1989, there have been outbreaks of meningococcal meningitis in several Canadian provinces. Meningococcus Group C was responsible for an outbreak of bacterial meningitis in PEI during 1990 to 1992. There were deaths among young adults during that outbreak.
Approximately 10 per cent of people who get a meningococcal disease will die and 10-20 per cent of survivors have long term effects including hearing loss, digit or limb amputations, and neurological disabilities.
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British Columbia Specific Information
Meningitis is an inflammation of the protective lining around the brain and spinal cord. It is a type of meningococcal infection that is usually caused by a virus or bacteria. In British Columbia, there are 2 vaccines that can help protect against meningitis: the Meningococcal C Conjugate vaccine and the Meningococcal Quadrivalent vaccine.
The Meningococcal C Conjugate vaccine is provided free. It is recommended for children at 2 and 12 months of age. For more information, see HealthLinkBC File #23a Meningococcal C Conjugate Vaccine and the B.C. Immunization Schedules.
As of September 2016, the Meningococcal Quadrivalent Vaccine will be offered to all students in grade 9 as part of the routine immunization program in B.C. This will replace the current booster dose provided in grade 6. For more information, see HealthLinkBC File #23b Meningococcal Quadrivalent Vaccines. To learn more about both vaccines, visit ImmunizeBC.
Babies Older People And The Menacwy Vaccine
The MenACWY vaccine is currently recommended for teenagers as they are most likely to carry the meningococcal bacteria at the back of their noses and throats.
The MenACWY vaccine protects teenagers when they’re most at risk of meningococcal disease. It also stops them carrying and spreading the bacteria to other people.
Vaccinating teenagers should also help protect other people, including babies and older people, against meningococcal disease, including the extremely harmful MenW strain.
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How Long Does The Meningitis Vaccine Last
Available data suggests that protection from meningococcal conjugate decreases in many teens within five years. Getting a booster, as determined by your health care provider, may be critical in maintaining protection when most at risk for meningococcal disease.
Some adolescents and young adults may also receive a serogroup B meningococcal vaccine. The preferred age for receipt is 16 through 18 years so adolescents have protection during the ages of increased risk.2
Economic Evaluations Of Meningococcal Disease And Vaccines
Data on the cost of vaccine and financial burden of disease have been published from Africa and some industrialized countries where a vaccine has been introduced. Limited data on meningococcal carriage and incidence are available from other countries, especially in Asia, and thus cost effectiveness cannot currently be accurately determined for these countries.
One study in Burkina Faso found that the cost per household of a case of meningococcal disease in Sub-Saharan Africa is US$ 90, with additional US$154 expenditure if sequelae of the disease occur. The urban cost is more than 200% higher than the rural cost. An idea of the overall burden of disease can be gaged from the total cost of the 20062007 outbreak, in Burkina Faso which was US$ 9.4 million, 7.1M borne by the public health system and 2.3M borne by households which comprised 34% of the GDP capita. The Meningitis Vaccine Project has the potential to:
Prevent 123 000 deaths by 2018
Prevent permanent disability in 287 000 children and adults
Prevent 11 million DALYs lost
Save approximately $99.7 million in medical costs for diagnosis and treatment
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When Are Meningococcal Vaccines Given
Vaccination with MenACWY is recommended:
- when kids are 11 or 12 years old, with a booster given at age 16
- for teens 1318 years old who haven’t been vaccinated yet
Those who have their first dose between the ages of 1315 should get a booster dose between the ages of 1618. Teens who get their first dose after age 16 won’t need a booster dose.
Kids and teens who are at higher risk for meningococcal disease need the full series of MenACWY vaccines, even if they’re younger than 11 years old. This includes kids who:
- live in or travel to countries where the disease is common
- are present during an outbreak of the disease
- have some kinds of immune disorders. If the immune disorders are chronic, these kids also need a booster dose a few years later, depending on their age at the first dose.
The sequence and dosage depends on the child’s age, medical condition, and vaccine brand. Some types of meningococcal vaccines can be given as early as 8 weeks of age.
Kids 10 years and older with these risk factors also should get the MenB vaccine. They’ll need 2 or 3 doses depending on the brand. They might need more booster doses as long as the risk factor remains.
For those without risk factors, the decision to receive the MenB vaccine should be made together by teens, their parents, and the doctor. For them, the preferred age range is 1618 years. Usually, they need 2 doses.
Simultaneous Administration With Other Vaccines
Men-C-C and 4CMenB vaccine may be administered concomitantly with routine childhood vaccines, and Men-C-ACYW vaccine may be administered concomitantly with adolescent and adult age appropriate vaccines. MenB-fHBP can be given concomitantly with quadrivalent human papillomavirus vaccine meningococcal serogroup A, C, Y, W conjugate vaccine and tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed. The concomitant administration of MenB-fHBP has not been studied with other vaccines.
Men-C-ACYW-CRM can be administered with routine paediatric vaccines however, further studies are needed with regard to concomitant administration with pneumococcal 13-valent conjugate vaccine. Co-administration of Men-C-ACYW-CRM and combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine may result in a lower immune response to the pertussis antigens than when Tdap vaccine is given alone however, the clinical significance of this is unknown. Tdap vaccine given one month after Men-C-ACYW-CRM induces the strongest immunologic response to pertussis antigens.
If vaccines are to be administered concomitantly with another vaccine, a separate injection site and a different syringe must be used for each injection.
Refer to Timing of Vaccine Administration in Part 1 for additional general information.
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Serogroup B Meningococcal Or Menb Vaccines
GlaxoSmithKline formulates each 0.5-mL dose of Bexsero® to contain:
- 50 µg each of recombinant proteins Neisserial adhesin A , Neisserial Heparin Binding Antigen , and factor H binding protein
- 25 µg of Outer Membrane Vesicles
- 5 milligrams aluminum hydroxide
- 125 mg sodium chloride
- 10 mg sucrose at pH 6.4 6.7
Each dose contains less than 0.01 µg kanamycin .
Pfizer formulates each 0.5-mL dose of Trumenba® to contain:
- 60 µg each of 2 lipidated fHBP variants
- 0.018 mg of polysorbate 80
- 0.25 mg of Al³+
- 10 millimolar histidine buffered saline at pH 6.0
Cost Effectiveness Of Men C Conjugate Vaccine
Six countries reported economic evaluations before the introduction of MCC vaccines , The Netherlands, UK, Portugal, and Switzerland). All of them recommended that one dose in the second year of life was more cost-effective than a three-dose infant schedule. Further development of the dynamic model was undertaken after vaccine introduction to predict the impact of the meningococcal vaccination program and its cost effectiveness in the UK. Various factors feed into this dynamic model, including the high transmissibility of the disease, the role of carriage/colonization and possibility of recurrent colonization with different serotypes, interaction between related bacteria, and the differing risks of colonization and disease at different ages. The model accurately reflected the trends of meningococcal disease in the UK when it was applied retrospectively to the actual experience in the UK from 1998 to 2004. It was also able to predict the significant herd protection that has been seen with the use of this vaccine. The UK model was also used to investigate the impact of vaccine schedules in the UK and Spain.
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How Are Cvs Pharmacy And Minuteclinic Different
At the pharmacy, vaccinations for adolescents through seniors are administered by certified immunizationâtrained pharmacist. Age and state restrictions apply. No appointment necessary.
At MinuteClinic, vaccinations for children through seniors are administered by a nurse practicioner. View wait times and schedule a visit online, or walk in anytime.
CVS Pharmacy and MinuteClinic also at Target
People With Medical Conditions That Increase Their Risk Of Invasive Meningococcal Disease
People with medical conditions specified in List. Specified medical conditions associated with increased risk of invasive meningococcal disease are strongly recommended to receive MenACWY and MenB vaccines.
- a full primary course of MenACWY vaccine, with ongoing booster doses
- a full primary course of MenB vaccine
People with these specific medical conditions have a higher risk of invasive meningococcal disease. They are recommended to receive extra doses compared with people who do not have these conditions.
The number of doses needed depends on the vaccine brand used and the persons age when they start the vaccine course.
For people aged 2 years receiving MenACWY vaccine, it is preferable to receive either Menveo or Nimenrix, rather than Menactra. If Menveo and Nimenrix are unavailable, Menactra can be given.
There is no preference for either Bexsero or Trumenba for people aged 10 years. For people aged < 10 years, Bexsero is the only registered MenB vaccine available in Australia.
Bexsero and Trumenba are not interchangeable. The same vaccine should be used for both vaccine doses.
Regular booster doses are required for MenACWY vaccines, but not for MenB vaccines.
For more details see:
People who have previously received a meningococcal polysaccharide vaccine
They should receive the 1st dose of MenACWY conjugate vaccine about 2 years after the most recent dose of 4vMenPV, with a recommended minimum interval of 6 months.1-3
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Risk By Age Group And By Aboriginal And Torres Strait Islander Status
Children aged < 2 years
Children aged < 2 years have the highest incidence of meningococcal cases. The disease occurs most often in infants aged 35 months.
Adolescents aged 1519 years
A high number of meningococcal disease cases occurs among adolescents and young adults aged 1524 years, with peak rates of disease occurring in 1820-year-olds. Adolescents and young adults have the highest rate of meningococcal carriage and are thought to play an important role in transmitting the bacteria in a community.4
Adolescents and young adults in this age bracket who have a higher risk of acquiring the meningococcal bacteria are:
- people who live in close quarters, such as new military recruits and students living in residential accommodation
- people who have prolonged contact with a person who is carrying meningococcal bacteria5-7
- people who are smokers8-10
Aboriginal and/or Torres Strait Islander people
Aboriginal and Torres Strait Islander people have much higher incidence rates of meningococcal disease than non-Indigenous Australians.96 This is particularly among children aged < 15 years for the 2 most common meningococcal serogroups: B and W.
What Is Meningococcal Conjugate Vaccine
Meningococcal disease is a bacterial infection that can infect the spinal cord and brain and cause meningitis, which can be fatal or lead to permanent and disabling medical problems.
Meningococcal disease spreads from person to person through small droplets of saliva expelled into the air when an infected person coughs or sneezes. The bacteria is usually passed through close contact with an infected person, especially through kissing or sharing a drinking glass or eating utensil.
Meningococcal conjugate vaccine is used to prevent infection caused by serogroups A, C, W, and Y. This vaccine helps your body develop immunity to meningitis, but will not treat an active infection you already have.
The Menactra brand of this vaccine is for use in children and adults between the ages of 9 months and 55 years old. Menveo is for children and adults between the ages of 2 months and 55 years old. MenQuadfi is for adults and children at least 2 years old.
Like any vaccine, meningococcal conjugate vaccine may not provide protection from disease in every person.
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Iv2 Efficacy Or Effectiveness
Pre-authorization efficacy trials are difficult to conduct because of the relative rarity of meningococcal disease therefore, antibody-dependent, complement-mediated, bactericidal activity measured using serum bactericidal assay is used as an immunological correlate of protection.
The efficacy of new conjugate meningococcal vaccines can be inferred from the demonstration of immunologic non-inferiority to authorized meningococcal vaccines. Regulatory approval therefore is based on post-vaccination immunogenicity data only. Post-licensure effectiveness of conjugate vaccines has relied on the screening methodFootnote 28 which requires accurate coverage data as well as the immunization status of cases. In Canada, the number of cases of meningococcal disease is small and it would take many years to have sufficient cases to be able to estimate vaccine effectiveness . In addition, the current quality of data from surveillance of coverage and cases is not high enough to enable VE to be measured. Immunogenicity is therefore the best method available.
Persons With Inadequate Immunization Records
Children and adults lacking adequate documentation of immunization should be considered unimmunized and started on an immunization schedule appropriate for their age and risk factors. Conjugate meningococcal vaccine, as appropriate for age, may be given regardless of possible previous receipt of the vaccine, as adverse events associated with repeated immunization have not been demonstrated. Refer to Immunization of persons with inadequate immunization records in Part 3 for additional general information.
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Preteens And Teens Are At Increased Risk For Meningococcal Disease An Uncommon But Serious Illness
Meningococcal disease can be devastating and oftenand unexpectedlystrikes otherwise healthy people. Although meningococcal disease is uncommon, teens and young adults 16 through 23 years old are at increased risk. Meningococcal bacteria can cause severe, even deadly, infections like
- Bacteremia or septicemia
About 1 in 5 people who survive their meningococcal infection have permanent disabilities.
Other Vaccines Against Meningococcal Disease
Several bacteria can cause meningitis and septicaemia, some of which can be prevented through vaccination.
The Hib/MenC vaccine is offered as part of the NHS vaccination programme to all babies after their 1st birthday.
The MenB vaccine is offered as part of the NHS childhood vaccination programme to all babies at 8 and 16 weeks, with a booster after their 1st birthday.
Page last reviewed: 2 April 2020 Next review due: 2 April 2023
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Who Should Get The Men
The Men-C vaccine is given to infants as a series of 2 doses. The first is given at 2 months of age, and the second at 12 months. The vaccine is given at the same time as other childhood immunizations.
The vaccine may also be given to people:
- born before 2002 who are 24 years of age and under who did not get a dose of vaccine on or after their 10th birthday
- 18 years of age and older who have had a stem cell transplant and
- who have been in close contact with someone with meningococcal type C disease.
It is important to keep a record of all immunizations received.
Fda Approves Menquadfitm The Latest Innovation In Meningococcal Vaccination
FDA approves MenQuadfiTM, the latest innovation in meningococcal vaccination
- Latest innovation in quadrivalent meningococcal vaccination designed for use in persons 2 years of age and older in the U.S.
- Safety and effectiveness studied in five double-blind, randomized clinical trials with nearly 5,000 individuals
- Helps protect an expanded age group and elicits a high immune response across multiple ages
- Under regulatory review in Europe and other countries to help support local immunization efforts
PARIS April 24, 2020 The U.S. Food and Drug Administration has approved a Biologics License Application for MenQuadfiTM Meningococcal Conjugate Vaccine for the prevention of invasive meningococcal disease in persons 2 years of age and older.
Meningococcal meningitis remains a major global health challenge because it can strike quickly and with devastating effect, taking a life in less than 24 hours. With the ability to help prevent this disease through vaccination, Sanofi believes one case is one too many, said David Loew, Executive Vice President, Sanofi Pasteur. Approval of this new vaccine in the U.S. represents an important milestone in the ongoing fight to help protect as many people as possible from meningococcal disease. It is our ambition to make this vaccine available to further expand protection to individuals worldwide.
MenQuadfi is Sanofis Latest MenACWY Innovation
MenQuadfis FDA approval is based on a robust clinical program
What is MenQuadfi?
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