Meningococcal Meningitis - Serogroups A, C, Y, W-135 and Serogroup B - Winnipeg Regional Health Authority

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Meningococcal Meningitis - Serogroups A, C, Y, W-135 and Serogroup B - Winnipeg Regional Health Authority
Meningococcal Meningitis - Serogroups A, C, Y, W-135 and Serogroup B
The disease, meningococcal meningitis, is a serious, sometimes fatal bacterial infection that occurs sporadically worldwide and in focal
epidemics. It is transmitted by person-to-person close contact with respiratory secretions or saliva of an infected person. Children and
young adults are most at risk for the disease. Meningococcal meningitis is characterized by a short incubation period followed by sudden
onset of symptoms. Meningococcal septicemia, in which bacteria rapidly disseminate through the bloodstream, is a less common form of
meningococcal disease, but has been responsible for the high case fatality rate in outbreaks of group C disease in Canada.

The five major serogroups most commonly associated with invasive disease are A, B, C, Y & W-135. Serogroups B & C are the most
frequent causes of sporadic cases and outbreaks in Europe & the Americas, followed by Y. Although serogroup A used to be the main
cause of epidemic disease, mainly in Africa and Asia, ssince 2010, 22 of the 26 countries in the African meningitis belt have introduced a
meningococcal A conjugate vaccine (MACV), and the decrease in the incidence of Neisseria meningitidis (N.m) A has been confirmed and
sustained. Serogroups Y and W-135 are relatively uncommon, but may be on the rise; during the past years, serogroup Y has emerged as
a cause of disease in Canada and the USA, and serogroup W-135 has been associated with meningococcal disease epidemics in Saudi
Arabia and Burkina Faso. Serogroup B is the most common source of meningococcal disease world-wide.

Epidemics most often occur during the winter-spring in temperate regions and in the dry season (which varies by country, but typically
between Nov & June) in tropical regions. The exact timing of the season varies from year to year and from country to country (occurring
earlier in the east and later in the west) (See Map 7-7). Vaccines against serogroups A, B, C, Y and W-135 are available in Canada.

The “meningitis belt” in Africa (see Map 7-8) is considered hyper-endemic for meningococcal meningitis. The disease is present all the time,
with epidemic rates (occurring between epidemics) often exceeding those in other countries. Epidemics in the belt occur in cycles that can last
2-3 years and tend to recur every 8-12 years. Since the 1980’s the intervals between epidemics have become shorter and more irregular.
During the dry season, the incidence rate of meningococcal disease can reach as high as 1,000 cases per 100,000 population. In non-
epidemic periods, the rate of meningococcal disease is roughly 5 - 10 cases per 100,000 population. The fatality rate is about 5 to 10%.
Since the mid-1990’s epidemics have become more frequent, and have spread beyond the usual boundaries. Outside the meningitis belt, there
is no evidence of a cyclical pattern of epidemics.

To identify travellers at higher risk and who should also receive vaccine (See Section II, Table 4 Meningococcal Meningitis):
• Countries in the meningitis belt (endemic), noted with the year of most recent activity - children and adolescents are at increased risk
• Countries that are outside of the meningitis belt that have experienced meningococcal meningitis activity (epidemic) within the last 2 -3
   years - rates rise in older children and young adults
Refer to the MHSAL Eligibility Criteria and to the Canadian Immunization Guide (CIG), Table 1 for individuals with underlying
medical conditions who meet the criteria for publicly funded meningococcal vaccines.

                                                                                                                                   Revised July 7, 2020
E -Vaccination for Serogroups A, C, Y, W-135 is Recommended for the following individuals, depending on
degree of exposure: In general, the following travellers do not need to receive serogroup B vaccine unless there is evidence of a
hyperendemic strain or an outbreak that is known to be caused by serogroup B that can be prevented by the vaccine:
 (The decision to recommend vaccination should be based on a careful assessment of risk, taking into account the destination, epidemiology of
disease, nature of exposure, and the health of the traveller).
    • All persons 2 months of age and older, travelling to an area of current epidemic disease (*within the last year) regardless of
       duration of exposure (Refer to Table 4, bolded countries).
    • Persons travelling to the meningitis belt or to African countries outside the usual boundaries of the meningitis belt, where there is not
       current activity but where epidemics have occurred within the past 2 – 3 years who will also be:
            o Living or working there
            o In close contact with the local population i.e.; through school, accommodations, or public transport.
                *Note: When making your assessment, risk in these areas is highest in the dry season (which varies between countries from
                Dec to June).
    • Persons travelling to areas (including developed countries) where sporadic epidemics (including meningococcal C) have been
       reported in the last 6 months (check Public Health Agency of Canada Advisories or WHO web sites). *Note: In developed countries,
       travellers should follow the meningococcal immunization recommendations of the destination country.
   •   Travellers to Saudi Arabia for the purpose of “Umrah” or the Hajj pilgrimage, or for seasonal work. Saudi Arabia requires
       evidence of vaccination (certificate of vaccination clearly documented with the name and type) against serogroups A, C, Y, W-135 for
       adults and children aged two years and older, administered no less than 10 days before arrival in Saudi Arabia. The vaccine name and
       type must be clearly indicated on the immunization certificate. For entry purposes:
           o Visitors from all countries: Visitors arriving for the purpose of Umrah or pilgrimage (Hajj) or for seasonal work are
             required to submit a certificate of vaccination with the quadrivalent (ACYW 135) vaccine against meningitis, proving the
             vaccine was administered in the past 3 years with a polysaccharide vaccine (no longer available in Canada) or 5 years
             with a conjugate vaccine and no less than 10 days before arrival in Saudi Arabia. The responsible authorities in the
             visitor’s country of origin should ensure that adults and children aged over 2 years are given 1 dose of the quadrivalent
             (ACYW135) vaccine and state clearly the type of the vaccine used on the vaccination card. If the vaccine type is not
             indicated on the certificate, the certificate will only be valid for 3 years.
           o Interior pilgrims and the Hajj workers: Vaccination with quadrivalent (ACYW135) vaccine is required for those who
             have not been vaccinated in the past 3 years with a polysaccharide vaccine (no longer available in Canada) or 5 years
             with a conjugate vaccine:
                      all citizens and residents of Medina and Mecca
                      all citizens and residents undertaking the Hajj (ie; domestic pilgrims)
                      all Hajj workers including individual working at entry points or those in direct contact with pilgrims, such as
                       personnel in healthcare settings

                                                                                                                                   Revised July 7, 2020
E -Vaccination for Serogroups A, C, Y, W-135 is Recommended for the following individuals, depending on
degree of exposure, in addition to consideration of serogroup B meningococcal vaccine:
   •   Travellers staying in schools, colleges & other places where large numbers of adolescents and your adults congregate
   •   Travellers engaging in research, industrial and/or clinical laboratory settings as well as military personnel may be at increased risk
       of disease or exposure to N. Meningitis
   •   Travellers with asplenia, functional or anatomic (including sickle cell disease); congenital complement deficiency; properdin; factor
       D or primary antibody deficiencies; acquired complement deficiency due to receipt of the terminal complement inhibitor
       eculizumab (Soliris™); HIV infection, especially if congenitally acquired and those with cochlear implants are at higher risk of
       complications from invasive meningococcal meningitis and should be provided vaccination with the conjugate quadrivalent vaccine
       regardless of potential for travel. (*Note: These individuals with underlying medical conditions meet the criteria for publicly funded
       vaccine according to Manitoba Health Seniors & Healthy Living).

Vaccine Usage:
   • Travellers who have previously received meningococcal conjugate vaccine against serogroup C (at 1 year of age and/or with the
      school based program) will not be protected against other serogroups and will therefore still require the quadrivalent conjugate
      vaccine, if indicated for their travel. Independent of travel, Conjugate C vaccine should be up-to-date for age, according to the
      provincial immunization schedule.
   • There are three conjugate quadrivalent vaccines (containing Groups A, C, Y, W-135) currently licensed in Canada; Menomune™ (a
      polysaccharide vaccine) has been discontinued in Canada:
                         ®
          o Menactra , Menveo™ & Nimenrix™ are the vaccines of choice for travellers, as they are known to have significant
             advantages over the polysaccharide vaccine:
             • Better immune memory
             • Longer duration of efficacy
             • Lack of hypo-responsiveness with booster doses
             • Possible reduction of bacterial carriage rate
   • There are two meningococcal serogroup B vaccines currently licensed in Canada: Bexsero® and Trumenba™

Respected Timeframes Between Meningococcal Vaccines:
    If a meningococcal conjugate vaccine is given, wait at least 1 month before administering another meningococcal conjugate vaccine.
    Meningococcal serogroup B vaccines can be given concomitantly with quadrivalent meningococcal serogroup A, C, Y, W conjugate
      vaccines or other vaccines

Interchangeability of Meningococcal Vaccines:
    There are no published data regarding the interchangeability of Men-C-C vaccines, but the vaccines have been safely interchanged
       without a noticeable decrease in efficacy.

                                                                                                                                  Revised July 7, 2020
 When possible, an infant series should be completed with the same vaccine. Either Men-C-ACYW vaccine may be used for re-
      vaccination, regardless of which meningococcal vaccine was used for initial vaccination.
    If providers are challenged with having to consider alternate use of conjugate quadrivalent vaccines to ensure travellers are provided some
      protection prior to departure (ie; during times of vaccine shortages etc.), the following principles should be used in your decision making:
          o For individuals 2 to 23 months of age:
                     Menveo™ should be the first-line recommendation (CIG recommendation)
                     Nimenrix® should be the alternative option, if Menveo™ is not available (product monograph indication)
                     If neither Menveo™ or Nimenrix® are available, Menactra® should be considered as a last option
                       (*off-label recommendation)
                           • Ensure parents are informed of this usage, and note that although adequate protection or efficacy may be assumed to
                               be similar, it cannot be guaranteed.
                           • Any prescriber who is recommending or administering this vaccine should be aware of the contents of the product
                               monograph and/or similarly approved standards or instructions for use. The manufacturer has received approval for
                               use of their product based on evidence as to the safety and efficacy of their product only when used in accordance
                               with the product monograph or similarly approved standard or instruction for use. This recommendation for use
                               may differ from that set out in the product monograph or other similarly approved standards or instructions for use
                               by the licensed manufacturer. Such recommendations may be endorsed by NACI, CIG or CATMAT, based on the
                               best available evidence.
    The two serogroup B meningococcal vaccines (MenB-fHBP and 4CMenB) are not interchangeable; the vaccine products contain different
      antigens and there are no published studies on the immunogenicity resulting from a vaccination series combining the two products.
      Therefore, the same vaccine product should be used for all doses in a vaccination series. If, in a person with an incomplete vaccination
      series, it is unknown what vaccine product they initially received, the initial dose(s) should be discounted and the vaccination series
      repeated using the same vaccine product for all doses in the new, repeated series.
Sources:
CIG: Meningococcal Vaccine;
Trumenba Product Monograph, May 24, 2019
Bexsero Product Monograph, June 12, 2020
Menveo Product Monograph, June 3, 2020
Nimenrix Product Monograph, Dec 19, 2018
Menactra Product Monograph, Nov 28, 2017
CATMAT Statement on Meningococcal Disease and the International Travel, May 7, 2015
Health Requirements and Recommendations for Travellers to Saudi Arabia for Hajj and Umrah; June 9, 2019
Weekly Epidemiological Record; 5 APRIL 2019, Nos. 14/15, 2019, 94, 179–188
NACI Update on Quadrivalent Meningococcal Vaccines available in Canada, April 2015
The Use of Bivalent Factor H Binding Protein Meningococcal Serogroup B (MenB-fHBP) Vaccine for the Prevention of Meningococcal B Disease, NACI, Jan
29, 2020
Advice for the Use of the Multicomponent Meningococcal Serogroup B (4CMenB) Vaccine, NACI, April 2014

                                                                                                                              Revised July 7, 2020
Recommended Quadrivalent Conjugate Meningococcal Vaccines (Men-C-ACYW-135*1) &
                             Serogroup B Meningococcal Vaccine *2 Schedules for Travellers
                      Recommended                                                                                           Booster Doses
       Age                                                         Schedule
                        vaccine(s)
2 to 11 months     Menveo™*3               2 or 3 doses *4 given 8 weeks apart*5 (with another         Men-C-ACYW-135:
of age             and/or Bexsero®         dose between 12-23 months of age that is at least 8            • If vaccinated at 6 years of age or younger:
                                           weeks from the previous dose) *5                                  every 3 to 5 years
12 to 23           Menveo™ *3              2 doses at least 8 weeks apart*5                               • If vaccinated at 7 years of age & older:
months of age      and/or Bexsero®                                                                           every 5 years
                                                                                                          • Travellers to the Hajj should check
24 months to 9     Men-C-ACYW-135*1 1 dose of Men-C-ACYW-135*1                                               recommendations for re-vaccination, as they
years of age                               2 doses of Bexsero® (4CMenB), given at least 8                    may require booster vaccination no more than
                   and/or Bexsero®         weeks apart                                                       3 years and no less than 10 days before
                                                                                                             arrival in Saudi Arabia.
10 years of age    Men-C-ACYW-135*1 1 dose of Men-C-ACYW-135*1                                         Serogroup B:
and older*6        and/or                  2 doses of Bexsero®, at least 4 weeks apart or                 • The need for a booster dose is yet to be
                   Bexsero® or                                                                               determined
                   Trumenba™               2 doses of Trumenba™, at least 6 months apart or
                                           3 doses of Trumenba™, at least 4 weeks apart, with
                                           another dose at least 4 months after dose two)
*1: Men-C-ACYW-135: Menactra® (Men-C-ACYW-DT), Menveo™ (Men-C-ACYW-CRM) or Nimenrix™ (Men-C-ACYW-TT)
*2: Serogroup B Meningococcal Vaccines: Bexsero® (4CMenB) - Multicomponent Meningococcal Serogroup B OR Trumenba™ (MenB-fHBP) - Bivalent
Meningococcal Serogroup B
*3: Men-C-ACYW-CRM (Menveo™) is authorized for use in children 2 months of age and older. Based on available published data in this age group,
Menveo™ should be used because it has been found to be safe and immunogenic.The schedules in this table are based on those used in published clinical
trials and the recommendation that a dose of meningococcal conjugate vaccine be given in the second year of life (12 to 23 months) for children vaccinated at less
than 1 year of age.
*4: For Bexsero® (4CmenB), depending on the age at which immunization is initiated, the manufacturer recommends two or three primary doses and a booster
(2 + 1 schedule or 3 + 1 schedule) when the first dose is received between the ages of 2 and 5 months, and two primary doses and a booster (2 + 1 schedule) when
the first dose is received between ages of 6 and 11 months. The booster dose should be administered in the second year of life.*See Biological page for schedule
*5: Men-C-ACYW-135 vaccines may be given a minimum of 4 weeks apart if accelerated immunization is needed.

*6: Serogroup B Meningococcal vaccines are not authorized for use in those 26 years of age and older and Men-C-ACYW-135 vaccines are not
authorized for use in those 56 years of age and older; however, based on limited evidence and expert opinion their use is considered appropriate above
these authorized ages (*CIG).

*Refer to section above on Interchangeability
                                                                                                                                                 Revised July 7, 2020
Initial Series          Reinforcements             Specific Contraindications              Expected Reactions

Meningococcal        Dosage:                 If vaccinated at 6 years   1. Known hypersensitivity to any        Common Local Reactions:
Meningitis           1 Dose                  of age or younger:         component of the vaccine: Sodium        2 to 10 year olds:
Conjugate            0.5 ml IM (deltoid      every 3 to 5 years         Chloride, Sodium Phosphate,             - Pain at the injection site (40 – 48%)
                     preferred site or                                  Anhydrous, *Syringes & vial             Adolescents and adults:
Menactra®            anterolateral part of   If vaccinated at 7 years   stopper latex-free                      - Pain at the injection site (52 - 64%)
A, C, Y, W-135       the thigh in those      of age & older:            2. Anaphylactic reaction to a           Common Systemic Reactions:
(Men-C-ACYW-DT)      12 to 23 months of      every 5 years              previous dose.                          2 to 10 year olds
                     age)                                               3. Previous history of Guillain-Barré   - Drowsiness (10 – 26%)
Sanofi Pasteur                                                          Syndrome                                - Irritability (11 – 35%)
                                             *Travellers to Saudi                                               - Diarrhea (12 –16%)
*Authorized in       Protection is           Arabia for the purpose     Caution:                                Adolescents and adults:
Canada for ages 9    established 8 – 28      of Umrah and Hajj          Menactra® has not been studied          - Headache (37 – 41%)
months to 55 years   days after              require the vaccine        with pregnant women; use only if the    - Fatigue (30 – 34%)
                     vaccination.            within past 5 years with   benefits outweigh the risks. May be     Very Rare:
                                             a conjugate vaccine        administered to women who are           - Guillain Barré Syndrome
                                             and no less than 10        breastfeeding.                          - Thrombocytopenia
                                             days before arrival.                                               - Urticaria
Biological           Initial Series          Reinforcements             Specific Contraindications              Expected Reactions
Meningococcal        Dosage:                 If vaccinated at 6 years   1. Known hypersensitivity to any        Very common (greater than 1 in 10):
Meningitis           1 Dose                  of age or younger:         component of the vaccine: Sucrose,      Loss of appetite, irritability,
Conjugate            0.5 ml IM (deltoid      every 3 to 5 years         Trometamol. Sodium chloride             drowsiness, headache, fever, swelling,
                     preferred site or                                  2. Anaphylactic reaction to a           pain & redness at the injection site,
Nimenrix™            anterolateral part of   If vaccinated at 7 years   previous dose.                          fatigue
A, C, Y, W-135       the thigh in those 6    of age & older:            3. Previous history of Guillain-Barré   Common (greater than 1 in 100):
(Men-C-ACYW-TT)      to 23 months of         every 5 years              Syndrome                                Diarrhea, vomiting, nausea, injection
                     age)                                                                                       site hematoma
Pfizer Canada        Protection is                                                                              Uncommon (greater than 1 in 1,000):
                     established 8 – 28                                 Caution:                                Insomnia, crying, dizziness, decreased
*Requires            days after                                         NIMENRIX® should be used during         feeling or sensitivity especially in the
reconstitution       vaccination.                                       pregnancy only when clearly needed      skin, itching, rash, aching muscles,
                                                                        and the possible advantages             pain in extremity (pain in the limb),
*Authorized in       Note: Although                                     outweigh the potential risks for the    generally feeling unwell, and injection
Canada for ages 6    NIMENRIX®               *Travellers to Saudi       fetus. May be administered to           site reaction (such as a hard lump at
weeks to 55 years    contains tetanus        Arabia for the purpose     women who are breastfeeding.            the injection site, itching warmth and
                     toxoid, this vaccine    of Umrah and Hajj                                                  loss of feeling)
                     does not substitute     require the vaccine                                                Rare (up to 1 in 1,000):
                     for tetanus             within past 5 years with                                           Large swelling of the vaccinated limb
                     immunization            a conjugate vaccine                                                associated with redness
                                             and no less than 10
                                             days before arrival.

                                                                                                                                       Revised July 7, 2020
Biological           Initial Series          Reinforcements             Specific Contraindications              Expected Reactions
Meningococcal        Dosage:                 If vaccinated at 6 years   1. Known hypersensitivity to any        Common (greater than 10%):
Meningitis           1 Dose                  of age or younger:         component of the vaccine:               Swelling, redness and soreness at
Conjugate            0.5 ml IM (deltoid      every 3 to 5 years         CRM197 or other diphtheria-             injection site headache, diarrhea,
                     preferred site or                                  containing vaccines;                    feeling tired or achy
Menveo™              anterolateral part of   If vaccinated at 7 years   Potassium dihydrogen phosphate,         Not Common (1 – 10%):
A, C, Y, W-135       the thigh in those      of age & older:            sucrose, sodium chloride, sodium        Fever, vomiting, rash
(Men-C-ACYW-CRM)     12 to 23 months of      every 5 years              dihydrogen phosphate monohydrate,       Very Rare:
                     age)                                               di-sodium hydrogen phosphate            Anaphylaxis (itchy hives, swelling of
GlaxoSmithKline                                                         bihydrate; *Latex Free and T-Free       the lips, face, tongue, legs and arms)
                     Protection is                                      2. Anaphylactic reaction to a
*Requires            established 8 – 28                                 previous dose.
reconstitution       days after              *Travellers to Saudi       3. Previous history of Guillain-Barré
                     vaccination.            Arabia for the purpose     Syndrome
*Authorized in                               of Umrah and Hajj
Canada for ages 2                            require the vaccine        Caution:
months to 55 years                           within past 5 years with   Menveo™ should be given during
                                             a conjugate vaccine        pregnancy only if the benefits of
                                             and no less than 10        vaccination clearly outweigh the
                                             days before arrival.       risks. May be administered to
                                                                        women who are breastfeeding.

                                                                                                                                       Revised July 7, 2020
Biological                Initial Series         Reinforcements               Specific Contraindications              Expected Reactions
Bivalent                  Standard Dosage        The need for a booster       1.Known hypersensitivity to any         Very Common (more than 1 in 10)
Meningococcal B           for Routine            dose following primary       component of the vaccine: aluminum      Headache, nausea, diarrhea, muscle
Vaccine                   Immunization:          immunization series has      phosphate, histidine, polysorbate 80,   pain, joint pain, redness, swelling and
                                                 not been established.        & sodium chloride                       pain at the injection site, chills and
                          2 doses                                             2. Anaphylactic reaction to a           fatigue
Trumenba™                 0.5ml IM*from a                                     previous dose
(MenB-fHBP)               prefilled syringe at   This vaccine is                                                      Common (more than 1 in 100
Recombinant               0 & 6 months           immunogenic, although        *syringes & plunger latex free          Vomiting, fever
                                                 its effectiveness, impact    The tip cap and rubber plunger of the
Dosage strength of                                                            syringe are not made with natural
60 mcg of subfamily       Dosage for             on carriage and herd
                          Individuals at         immunity, and its duration   rubber latex
A and 60 mcg of
subfamily B rLP2086       Increased Risk of      of protection remain
                          Invasive               unknown.                     Caution:
(120 mcg total                                                                There are no data from the use of
protein) per 0.5 mL       Meningococcal
                          Disease (IMD):                                      Trumenba™ in immunocompromised
dose.                                                                         individuals or in pregnant women. It
Pfizer Canada             3 doses                                             is unknown if Trumenba™ is
                          0.5ml IM* from a                                    excreted in human milk. Only use in
                          prefilled syringe                                   these circumstances, if the potential
                          with the first 2                                    benefits clearly outweighs the
Notes:                                                                        potential risks.
Shake vigorously          doses at least 1
before use to ensure      month apart,                                        Give with caution to individuals with
a homogeneous             followed by a third                                 thrombocytopenia or any coagulation
white suspension is       dose at least 4                                     disorder or to those receiving
obtained.                 months after the                                    anticoagulant therapy, unless
                          2nd dose                                            the potential benefit clearly
Do not use the                                                                outweighs the risk of administration.
vaccine if it cannot be
re-suspended or if        *Deltoid preferred
particulate matter or     site
discolouration is
found.                    Note:
                          Due to lack of
Syringes should be        data,
stored in the             meningococcal
refrigerator              group B vaccines
horizontally (laying      are not
flat on the shelf) to     interchangeable.
minimize
the re-dispersion
time.

*Authorized in
Canada for ages 10
through 25 years

                                                                                                                                             Revised July 7, 2020
Biological               Initial Series     Reinforcements           Specific Contraindications              Expected Reactions
                         Dosage:            The need for a booster   1. Known hypersensitivity to any        Local Reactions:
Multicomponent           0.5 ml IM          dose is yet to be        component of the vaccine:               Tenderness and redness at the
Meningococcal                               determined.              Kanamycin, Sodium Chloride,             injection site; induration.
Vaccine                  *See chart below                            Histidine, Sucrose, Aluminum
                         for Schedule:                               Hydroxide, Natural Rubber Latex         Systemic Reactions:
Bexsero®                                                             (tip cap of the syringe)                Adults: Headache, malaise, myalgia,
(4CMenB)                                                             2. Anaphylactic reaction to a
Recombinant,                                                         previous dose                           Infants & children:
                                                                                                             Fever, irritability, unusual crying,
adsorbed                                                             Caution:                                sleepiness
                                                                     - Not expected to provide protection    Uncommon (≥ 1/1,000 to < 1/100):
GlaxoSmithKline                                                      against all circulating meningococcal   Fever ≥40°C, nervous system
                                                                     serogroup B strains or other invasive   disorders, seizures (including febrile
                                                                     meningococcal disease (IMD).            seizures), skin & subcutaneous tissue
                                                                     - In immunocompromised                  disorders, eczema, urticaria, vascular
                                                                     individuals, vaccination may not        disorders, pallor (rare after booster)
                                                                     result in a protective antibody         Rare (≥ 1/10,000 to < 1/1,000):
                                                                     response.                               Kawasaki syndrome
                                                                     - Should only be given during
                                                                     pregnancy or when breastfeeding if
                                                                     the benefits of vaccination clearly
                                                                     outweigh the risks, as there are no
                                                                     studies.

White opalescent
liquid suspension in a
prefilled syringe. A
fine off-white deposit
may form when the
product stands for a
long period. Shake
the vaccine well
before use.

*Authorized in
Canada for ages 2
months to 25 years

                                                                                                                                   Revised July 7, 2020
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