| Meningococcal B |
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| Disease Issues |
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Please tell us about meningococcal disease. |
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| Meningococcal
disease is a bacterial infection caused by
Neisseria meningitidis. Meningococcal disease
usually presents clinically as meningitis
(about
50% of cases), bacteremia (30% of cases), or
bacteremic pneumonia (15% of cases). N.
meningitidis colonizes mucosal surfaces of the nasopharynx
and is transmitted through direct contact with
large-droplet respiratory tract secretions
from patients or asymptomatic carriers.
Meningococcal disease can
be severe. The overall case-fatality ratio in
the U.S. is 15%, and 10%-20% of survivors have
long-term sequelae such as neurologic
disability, limb or digit
loss, and hearing loss. |
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| N. meningitidis
is classified into 12 serogroups based on
characteristics of the polysaccharide capsule.
Most invasive disease (such as meningitis and
sepsis) is caused by serogroups A, B, C, W, X
and Y. The relative importance of serogroups
depends on geographic location and other
factors such as
age. Serogroups B and C are the most frequent
causes of disease in the U.S., accounting for
42% and 26% of cases with known serogroup, respectively,
during 2015–2018. Serogroups W, Y, and nongroupable strains each caused 9%–14% of
cases during that period. Serogroup A is rare
in the U.S.
Historically, serogroup A was common in the
meningitis belt of sub-Saharan Africa, but
after the implementation of a meningococcal
serogroup A conjugate
vaccine campaign, serogroup A disease has been
nearly eliminated in the meningitis belt. |
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| Nasopharyngeal
carriage rates are highest in adolescents and
young adults who serve as reservoirs for transmission of N. meningitidis. |
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How common is meningococcal disease? |
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| The incidence of
meningococcal disease has declined steadily in
the U.S. since a peak of reported disease in
the late 1990s. Even before routine use of a
meningococcal conjugate vaccine (MenACWY) in
adolescents was recommended in 2005, the
overall annual incidence of meningococcal
disease had
decreased 64%, from 1.1 cases per 100,000
population in 1996 to 0.4 cases per 100,000
population in 2005. In 2018, the rate of meningococcal disease
in the U.S. reached a historic low of 0.1
cases per 100,000 population. Incidence of
disease caused by serogroup B, a serogroup not
included in the
routinely recommended MenACWY vaccine, also
has declined for reasons that are not known. |
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| During 2015–2018,
an estimated 360 cases of meningococcal disease
occurred annually in the United States, representing an average annual incidence
of 0.11 cases per 100,000 population. Of those
with known serogroup in 2018 (N=302), 39% were
serogroup B and 51% were serogroups C, Y, or W-
135. The incidence of disease is highest in
infants under 1 year, children age 1 year, and
adolescents age 16–20 years. |
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What groups are at increased risk for
meningococcal disease? |
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| In addition to
risk based on age, non-specific risk factors
for serogroups A, C, W and Y include having a
previous viral infection, living in a crowded
household, having an underlying chronic
illness, and being exposed to cigarette smoke
(either directly or second-hand). |
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| The following
groups are at increased risk for all
meningococcal serogroups: |
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People with persistent (genetic)
complement component deficiencies (a type
of immune system disorder) |
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People who use complement inhibitors such
as eculizumab (Soliris, Alexion
Pharmaceuticals) and ravulizumab (Ultomiris,
Alexion
Pharmaceuticals) for treatment of atypical
hemolytic uremic syndrome or paroxysmal nocturnal hemoglobinuria |
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People with anatomic or functional
asplenia |
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Microbiologists routinely exposed to
meningococcal isolates in a laboratory |
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People at increased risk during an
outbreak of meningococcal disease |
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Military recruits |
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College students |
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| Certain groups
are at increased risk of serogroups A, C, W
and Y, but not serogroup B: |
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People living with HIV |
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Men who have sex with men (MSM) |
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Travelers to countries where meningococcal
disease is endemic or hyperendemic, such
as the meningitis belt of sub-Saharan
Africa |
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What meningococcal vaccines are available in
the United States? |
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| The vaccines for
meningococcal serogroups A, C, W, and Y
(MenACWY; Menactra, Sanofi Pasteur; Menveo, GlaxoSmithKline [GSK]; MenQuadfi, Sanofi
Pasteur) contain meningococcal conjugate in
which the surface polysaccharide is chemically
bonded ("conjugated") to a protein to produce
a robust
immune response to the polysaccharide.
Although each of the 3 MenACWY vaccine
products uses a different protein conjugate,
the products are
considered interchangeable; the same vaccine
product is recommended, but not required, for
all doses. |
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| A discontinued
meningococcal polysaccharide vaccine (MPSV4,
Menomune, Sanofi Pasteur) was available in the United States until all doses expired in
September 2017. With rare exception, it was
not interchangeable with MenACWY conjugate
vaccines. |
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| Since late 2014,
vaccines have become available that offer
protection from meningococcal serogroup B
disease (MenB; Bexsero, GSK; Trumenba,
Pfizer). These vaccines are composed of
proteins found on the surface of the bacteria.
These vaccine products are not
interchangeable; the same
vaccine product is required for all doses. |
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| MenACWY vaccines
provide no protection against serogroup B
disease, and meningococcal serogroup B vaccines (MenB) provide no protection against
serogroup A, C, W, or Y disease. For
protection against all 5 serogroups of
meningococcus, it is necessary to receive both
MenACWY and MenB. |
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Trade Name |
Type of Vaccine |
Serogroups |
Year Licensed |
Approved Ages |
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| Menactra |
Conjugate |
A, C, W, Y |
2005 |
9 mos.–55
years* |
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| Menveo |
Conjugate |
A, C, W, Y |
2010 |
2 mos.–55
years* |
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| MenQuadfi |
Conjugate |
A, C, W, Y |
2020 |
2 years and
older |
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| Trumenba |
Protein |
B |
2014 |
10–25
years* |
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| Bexsero |
Protein |
B |
2015 |
10–25
years* |
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| *May be given to
adults at increased risk older than the
FDA-approved upper age limit (see ACIP
recommendations, Table 11, page 41,
www.cdc.gov/mmwr/volumes/69/rr/pdfs/rr6909a1-H.pdf) |
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Where can I find the most current
meningococcal vaccine recommendations? |
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| The most current
comprehensive recommendations from the
Advisory Committee on Immunization Practices (ACIP) for meningococcal vaccines is
available on the MMWR website at
www.cdc.gov/mmwr/volumes/69/rr/pdfs/rr6909a1-H.pdf.
This document replaces all previously
published reports and
policy notes. |
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Who is recommended to be vaccinated against
meningococcal B disease? |
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| MenB is routinely
recommended for these groups: |
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People age 10 years and older who have
functional or anatomic asplenia (including
sickle cell disease) |
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People age 10 years and older who have
persistent complement component deficiency
(an immune system disorder) or who take a
complement
inhibitor such as eculizumab (Soliris,
Alexion Pharmaceuticals) or ravulizumab (Ultomiris,
Alexion Pharmaceuticals) |
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People age 10 years and older who are
exposed during an outbreak caused by
serogroup B |
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Microbiologists who work with
meningococcal isolates in a laboratory |
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| For adolescents
and young adults not otherwise at increased
risk for meningococcal B disease, ACIP
recommends that a MenB series may be
administered to people 16 through 23 years of
age (preferred age 16 through 18 years) on the
basis of shared clinical decision-making. The
shared
clinical decision-making recommendation allows
the clinician and patient to decide together
based upon the risks and benefits of
vaccination for the
individual patient. |
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ACIP has changed its MenB vaccine
recommendation for adolescents not otherwise
at increased risk of meningococcal disease
from "Category B" to
"shared clinical decision-making." What does
this mean? Does the Affordable Care Act (ACA)
require health plans (non-grandfathered) to
provide benefit
coverage on vaccines recommended for shared
clinical decision-making? |
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| The change from
"Category B" to "shared clinical
decision-making" was done to describe more
clearly the intent of the recommendation that
the patient
should be informed of the option to be
vaccinated against meningococcal serogroup B
disease and that the decision to vaccinate
against MenB should be
made by the provider and patient together. ACA
requires coverage of vaccines as indicated on
the recommended immunization schedule,
including
vaccines with shared clinical decision-making
recommendations. The Vaccines for Children (VFC)
program also covers vaccines recommended for
shared clinical decision-making. |
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What kind of information about MenB vaccine
should be considered with a patient when
conducting shared clinical decision-making? |
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| To assist with
the shared clinical decision-making around the
option to vaccinate against meningococcal serogroup B disease and the timing of
vaccination, CDC has provided some specific
considerations about the disease and the
vaccine that the patient and provider may
weigh: |
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Serious nature of invasive meningococcal
serogroup B infection, with a high risk of
death and permanent complications |
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Low level of serogroup B disease in the
United States, with an average of 34 cases
each year among people age 16 through 23
years between
2015 and 2018 |
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Increased risk among college students,
especially those who are freshmen,
attending a 4-year university, living in
on-campus housing, or
participating in sorority and fraternity
life |
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Protection of MenB vaccine against most
strains of meningococcal serogroup B
bacteria |
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Estimated relatively short duration of
MenB vaccine protection, with antibody
levels waning within 1–2 years of completing the primary series |
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Evidence to date suggests no impact of
MenB vaccine on meningococcal B carriage
(may protect an individual from invasive
disease but is
unlikely to impact transmission of the
bacteria to others) |
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The ACIP recommendations for meningococcal
serogroup B (MenB) vaccine say the vaccine
will provide "short term protection." What
does "short term
protection" mean? |
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| MenB vaccines
were approved based on the serologic response
to the vaccine. No data are available on
vaccine effectiveness against clinical disease
or
duration of protection against clinical
disease. Short term protection refers to the
known duration of the antibody response.
Available data indicate that
protective antibody levels wane in most
recipients within 1–2 years of completion of
the primary series. |
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Should college students be vaccinated
against meningococcal serogroup B disease? |
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| Several small
outbreaks of meningococcal serogroup B disease
have occurred on college campuses since 2013. Data derived from enhanced CDC
meningococcal disease surveillance suggest
that college students have 3.5 times the risk
of meningococcal serogroup B disease relative
to peers not
attending college, although the disease incidence in college students remains very low
(0.17 cases per 100,000 population). ACIP does
not routinely
recommend MenB vaccine for college students.
However, the recommendation for shared
clinical decision-making applies to all
college students age 16
through 23 years who may choose to receive
MenB vaccine to reduce their risk of
meningococcal serogroup B disease. In
addition, some colleges and
universities require MenB vaccination for
incoming students. |
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What is the schedule for MenB? |
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| Trumenba (MenB-Fhbp,
Pfizer) is either a 2-dose series with doses
administered at least 6 months apart or a
3-dose series with the second and third
doses administered 1–2 and 6 months after the
first dose. Bexsero (MenB-4C, GSK) is a 2-dose
series with doses given at least 1 month
apart. |
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Which patients should receive a 2-dose
schedule of Trumenba (MenB-FHbp)? |
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| Healthy
adolescents who are not at increased risk for
meningococcal B disease should receive 2 doses
of Trumenba (MenB-FHbp) administered at 0 and
6 months. If the second dose is given at an
interval of less than 6 months, a third dose
should be given at least 4 months after the
2nd dose. |
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| For people age 10
years and older at increased risk for
meningococcal B disease, 3 doses of Trumenba
should be administered at 0, 1–2, and 6
months.
The 3-dose series should be used for all
people with functional or anatomic asplenia,
people with persistent complement component
deficiency (an
immune system disorder) or those who take a
complement inhibitor (eculizumab [Soliris] or
ravulizumab [Ultomiris]), microbiologists who
work with
meningococcal isolates in a laboratory, and
people exposed during serogroup B outbreaks. |
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A microbiologist in our facility received 2
doses of Trumenba (MenB-FHbp) 6 months apart.
Does he need to receive a third dose? |
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| No. The 3-dose
series (at 0, 1–2 and 6 months) is intended to
rapidly induce immunity to serogroup B meningococcal bacteria. If a microbiologist or
other
person at increased risk has received 2 doses
of Trumenba separated by 6 months their
vaccine series can be considered to be
complete. |
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I have a patient who was given his first dose
of Trumenba (MenB-FHbp) two weeks ago in May,
but he just learned that his university
requires all students
to complete MenB vaccination before arriving
on campus in September. His next dose of
Trumenba is due in November. What can we do? |
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| The only way to
meet the school entry deadline for a complete
series by September would be to restart a
primary series with Bexsero (MenB-4C), which
requires two doses spaced at least 4 weeks
apart. You must wait a minimum of 4 weeks
after the Trumenba dose to initiate the Bexsero series. |
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If a patient received Trumenba meningococcal B
vaccine (MenB-FHbp) 2 months ago and Bexsero
meningococcal B vaccine (MenB-4C) yesterday,
should they complete the series with Trumenba
or with Bexsero since the two brands are not
interchangeable? What would be the intervals
from the
Bexsero dose to the subsequent dose(s)? |
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| The patient can
complete the series with either vaccine. If
Bexsero (MenB-4C) is chosen, the second and
final dose should be administered at least 1
month after yesterday’s dose. If Trumenba
(MenB-FHbp) is chosen and the patient is
healthy (i.e., does not have a high-risk
condition for meningococcal
B disease such as asplenia), the second and
final dose of Trumenba should be administered
at least 4 months after yesterday’s Bexsero
dose (6 months
after the first Trumenba dose). If the person
is at increased risk for meningococcal B
disease and Trumenba is being used, a second
Trumenba dose
should be administered 1 month after
yesterday’s Bexsero dose and a third dose
should be administered 4 months after the
second Trumenba dose. |
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Can you provide a comprehensive overview of
the MenB recommendations? |
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| IAC has prepared
a document that provides a summary of the ACIP
recommendations for use of MenB. The document
is available at
www.immunize.org/catg.d/p2035.pdf. |
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Are the two MenB vaccines interchangeable? |
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| No. The ACIP
meningococcal serogroup B vaccine
recommendations state that the same vaccine
must be used for all doses in the MenB series,
including
booster doses. If the brand of a previous dose
is unavailable or cannot be determined,
restart the primary series with the available
brand. |
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| Do any of the
bacterial vaccines that are recommended for
people with functional or anatomic asplenia need to be given before splenectomy? Do the
doses count if they are given during the 2
weeks prior to surgery? |
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| Pneumococcal
conjugate vaccine (PCV13), Haemophilus
influenzae type b (Hib) vaccine, meningococcal
ACWY vaccine, and MenB vaccine should be
given 14 or more days before splenectomy, if
possible. Doses given during the 2 weeks (14
days) before surgery can be counted as valid.
If the doses
cannot be given prior to the splenectomy, they
should be given as soon as the patient's
condition has stabilized after surgery.
Pneumococcal
polysaccharide vaccine (PPSV23) should be
administered 8 weeks after the dose of PCV13
for people 2 years of age and older. |
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| Our practice has an
11-year-old patient who is having a splenectomy. The doctor
requested meningococcal serogroup B vaccine (MenB) before the
surgery and wants to know if the patient will need booster
doses or a repeat MenB series at some point in the future (as
in the meningococcal ACWY
vaccine recommendations). |
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| Yes. The 2020 ACIP
recommendations for MenB include a booster dose schedule for
MenB vaccination of people at high risk for meningococcal
serogroup B disease. The first booster dose is recommended one
year after completion of the primary series, with a subsequent
booster dose
administered every 2–3 years thereafter, as long as risk
remains. Because MenB vaccine brands are not interchangeable,
all doses, including booster
doses, should be of the same MenB brand. If the brand of the
primary series is not known or not available, CDC recommends
restarting the primary series
with the available product. |
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| I have a
patient with paroxysmal nocturnal
hemoglobinuria who is being treated with
Soliris (eculizumab). Should he receive
meningococcal vaccine? |
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| Eculizumab (Soliris)
and the related long-acting compound,
ravulizumab (Ultomiris) bind to C5 and inhibit
the terminal complement pathway. People with
persistent complement component deficiency due
to an immune system disorder or use of a
complement inhibitor are at increased risk for
meningococcal
disease even if fully vaccinated. This patient
should be given a series of MenACWY vaccine,
MenACWY (2 doses separated by at least 8
weeks) and a 2-
or 3-dose series (depending on brand) of MenB
vaccine. The patient should receive regular booster doses of MenACWY and MenB as long as
he remains
at risk: a booster dose of MenACWY every 5
years and a booster dose of MenB one year
after completion of the primary series,
followed by a booster
dose of MenB every 2–3 years thereafter. |
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| Because patients
treated with complement inhibitors can develop
invasive meningococcal disease despite vaccination, clinicians using Soliris or
Ultomiris
also may consider antimicrobial prophylaxis
for the duration of complement inhibitor
therapy. |
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| We have a
10-year-old getting renal dialysis. The
nephrologist will be starting her on
ravulizumab (Ultomiris), which interferes with
C5 complement. If we
administer MenACWY and pneumococcal polysaccharide vaccine (PPSV23) now, and then
give her PCV13 in 8 weeks, will the PCV13
interfere with the
efficacy of the PPSV23 or the MenACWY? |
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| Recommendations
to separate MenACWY and PCV13 only apply to
one of the three MenACWY vaccines, MenACWY-D
(Menactra), and also only apply
to individuals with functional or anatomic
asplenia or HIV infection. So the best
schedule is to give MenACWY (any brand)
simultaneously with PCV13,
and then PPSV23 in eight weeks. ACIP
recommends giving PCV13 before PPSV23 in order
to maximize the immune response from PCV13. PPSV23
may blunt the immune response to PCV13 if
PCV13 is given after PPSV23, although in
children there is a smaller effect than in
adults. A 10 year-old with
persistent complement component deficiency
also should receive a 2- or 3-dose series
(depending on brand) of MenB vaccine. |
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| As long as the
child remains at high risk of meningococcal
disease due to complement inhibitor use,
booster doses of both MenACWY and MenB are
recommended. A MenACWY booster dose should be
given every 5 years and a MenB booster dose
should be given one year after the completion
of the
primary series, followed by a booster dose
every 2–3 years thereafter. |
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| Are people who
are HIV-positive in a risk group for
meningococcal disease? |
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| Yes. Studies from
the United States, South Africa, and the
United Kingdom have shown that people with HIV infection have a risk of invasive
meningococcal disease that is 11–24 times
higher than the general population. In the
United States, this excess risk is
specifically for serogroups C, W,
and Y. ACIP recommends routine MenACWY
vaccination of all HIV-infected people 2
months of age and older. Children younger than
age 2 years should
be vaccinated using a multidose schedule based
upon age (see the IAC document "Meningococcal Vaccine Recommendations by Age and Risk Factor
for
Serogroups A, C, W, or Y Protection" available
at
www.immunize.org/catg.d/p2018.pdf for
details). |
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| People age 2
years and older with HIV infection who have
not been previously vaccinated should receive
a 2-dose primary series of MenACWY (doses
separated by at least 8 weeks). People with
HIV infection who have previously received one
dose of MenACWY should receive a second dose
at the
earliest opportunity (at least 8 weeks after
the previous dose) and then receive booster
doses at the appropriate intervals. ACIP does
not recommend
routine meningococcal serogroup B vaccination
of people with HIV infection: MenB may be
given based upon shared clinical
decision-making to people
with HIV who are age 16 through 23 years old,
preferably between ages 16 and 18 years. |
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| If you choose
to give Trumenba brand MenB vaccine (MenB-FHbp)
to a 16-year-old with HIV infection based on
shared clinical decision-making, should
you use the 2-dose (standard) schedule or the
3-dose (high-risk) schedule? |
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| Either Trumenba
(MenB-FHbp) or the Bexsero MenB vaccine brand
(MenB-4C) may be used for people with HIV infection. If Trumenba is administered,
the CDC meningococcal subject matter experts
recommend that the 3-dose schedule should be
used. People with HIV infection do not appear
to be at
higher risk for meningococcal serogroup B
disease, but because of their HIV infection
they might not respond to the vaccine as well,
the 3-dose schedule
is preferred. When Bexsero is used, the
schedule is 2 doses, regardless of risk
status. Booster doses of MenB are not
recommended for people with HIV
in the absence of another indication for MenB
vaccination. |
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| I have a
7-year-old patient with congenital asplenia.
She has already received PCV13 and
meningococcal ACWY conjugate vaccine. Would
you consider
giving her meningococcal B vaccine (MenB)? |
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| Use of either
brand of MenB in persons younger than age 10
years is off-label in the U.S. There is no
ACIP recommendation for use of this vaccine
for
this age group. |
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| Bexsero (MenB-4C)
has been studied among infants and is approved
for infants by the European Medicines Agency
(the European version of the U.S.
Food and Drug Administration). It is routinely
recommended for infants in the United Kingdom
(see
www.nhs.uk/conditions/vaccinations/pages/meningitis-b-vaccine.aspx for details). A clinician may
choose to use a vaccine off-label if, in their
opinion, the benefit of the vaccine exceeds
the risk from the
vaccine. |
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| Are
microbiologists recommended to receive MenB
vaccine? And if so, how frequently? |
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| ACIP recommends
that microbiologists who work with
meningococcal isolates in a laboratory receive
both MenB and MenACWY vaccines. MenB can be
given at the same time as any other vaccine.
You can administer either two doses of Bexsero
(MenB-4C) 4 weeks apart, or three doses of
Trumenba
(MenB-FHbp) on a 0-, 1–2-, and 6-month schedule. |
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| Because
protective antibody levels begin to wane
within 1–2 years after completing the primary
series, ACIP recommends a booster dose of MenB
one
year after completing the primary series,
followed by a booster dose every 2–3 years
thereafter, as long as risk remains. MenB
vaccine brands work
differently and are not interchangeable. All
doses, including booster doses, should be of
the same brand. If the brand of the primary series is not known or
is not available, restart the primary series
with the available brand. |
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| We have a
19-year-old patient with a history of
vasculitis, nephritis, and asthma. She is on
azathioprine (Imuran) and is immunosuppressed.
Her
rheumatologist recommends she receive
pneumococcal conjugate vaccine (PCV13, Prevnar
13, Pfizer) and MenB vaccine. How often should
these
vaccines be given? Will she require a series
of PCV13 doses or just a booster? |
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| For people with
iatrogenic immunosuppression, ACIP recommends
1 dose of PCV13 followed by a dose of PPSV23 at least 8 weeks later (see
www.cdc.gov/mmwr/pdf/wk/mm6434.pdf, pages
944–7). |
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| MenB is not
specifically recommended for immunosuppressed
people. However, after discussing the pros and cons of vaccination (also known as shared
clinical decision-making), people age 16
through 23 years who are not at increased risk
may receive routine MenB vaccination with
either a 2-dose series
of Bexsero (MenB-4C) 4 weeks apart, or a
2-dose series of Trumenba (MenB-FHbp) 6 months
apart. |
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| I have a
10-year-old patient traveling to Kenya for one
week. In addition to MenACWY vaccine, should
she be offered meningococcal serogroup B
(MenB) vaccine? |
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| ACIP does not
recommend routine MenB vaccination for travel
to countries in sub-Saharan Africa or to other countries for which MenACWY vaccine is
recommended. Meningococcal disease in these
areas is generally not caused by serogroup B. |
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Which groups should receive a booster dose of
MenB? |
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| ACIP recommends
booster doses of MenB vaccines for people at
increased risk of MenB disease. Booster doses should be administered to people in the
following groups as long as increased risk
remains: |
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People with functional or anatomic
asplenia, including sickle cell disease |
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People with persistent complement
component deficiency (an immune system
disorder) |
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People who take a complement inhibitor (eculizumab
[Soliris] or ravulizumab [Ultomiris]) |
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Microbiologists who routinely work with
meningococcal isolates |
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Previously vaccinated people who are at
risk during a meningococcal B disease
outbreak |
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Because protective antibody levels produced by
the primary series begin to wane within 1–2
years, the first booster dose is recommended
one year after
completion of the primary series, with
subsequent booster doses every 2–3 years as
long as increased risk remains. Previously
vaccinated people
identified by public health as being at risk
during a meningococcal B outbreak should
receive a booster dose if it has been at least
one year since
completion of their primary series, though
depending upon the specific circumstances,
public health may recommend a booster dose as
little as 6 months
after completion of the primary series. |
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| I have a 28
year-old patient who received a primary MenB
vaccine series of Bexsero in 2015 when her spleen was removed. At that time, the ACIP did
not
have a recommendation for booster doses. Do I
need to give her a new primary series? |
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| ACIP voted to
recommend MenB booster doses for people at
ongoing increased risk of meningococcal
serogroup B disease in June 2019 and the
recommendation was published in 2020 (www.cdc.gov/mmwr/volumes/69/rr/pdfs/rr6909a1-H.pdf).
As long as you use Bexsero (MenB-4C) as the booster
dose, the patient does not need to restart the
primary series. This patient should be given a
booster dose of Bexsero now and receive
subsequent booster
doses every 2–3 years. |
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| Brands of MenB
vaccine work differently and are not
interchangeable. The only time ACIP recommends
restarting the primary series is if the brand
used
for the primary series is not known or is
unavailable. |
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| Public health
authorities have declared a meningococcal
serogroup B disease outbreak at my university and we are now vaccinating all students on
campus. Some students report having had a
primary series of MenB vaccine, but do not
have documentation of which brand was used.
What should we
do? |
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| During an
outbreak of meningococcal B disease, swift
protection of those at risk is prioritized and
CDC subject matter experts do not recommend
delaying
vaccination in order to locate records.
Student health services with documentation of
MenB vaccination (including brand) of incoming
students, either in a
state immunization registry or in student
health records, will be able to respond most
efficiently to an outbreak. |
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| Students whose
primary series of MenB vaccine was completed
at least 1 year before the outbreak (or as
little as 6 months before the outbreak, if
recommended by public health) should receive a
single booster dose of the same brand of MenB
vaccine. If the same brand is unavailable,
they should
restart the primary series with the available brand. If the brand of the primary series is
unknown, administer a dose of the available
product and counsel
the recipient to request records of the
primary series: if the primary series brand is
different, then in order to ensure optimal
protection, the recipient
should be given a booster dose of the primary
series product or complete a primary series
with the available product after a minimum
interval of 4 weeks. |
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| I know the
primary series of MenB vaccine should use the
same brand for all doses. Does that also apply to booster doses? |
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| Yes. MenB
vaccines work differently and receiving
mismatched MenB doses might result in
inadequate protection. For this reason,
documentation of the
brand of vaccine in immunization is especially
important. If a patient at high risk requires
a booster dose and the brand of the primary
series doses cannot
be determined or is unavailable, then CDC
recommends restarting the primary series with
the available brand. |
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| The first booster
dose is recommended one year following
completion of the primary series with
subsequent booster doses every 2–3 years
thereafter, as
long as risk remains. |
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| By what route
should meningococcal vaccines be administered? |
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| All meningococcal
vaccines available in the United States,
including MenACWY and MenB are given by the intramuscular route. |
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| Can MenACWY
and MenB vaccines be given at the same visit? |
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| Yes. MenACWY and
MenB vaccines can be given at the same visit
or at any time before or after the other. |
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| What adverse
events are expected after receiving MenB? |
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| In clinical
trials and in postlicensure safety
surveillance, the most common local adverse
events within 7 days of receiving MenB were
injection site pain,
swelling or redness and the most common
systemic symptoms were headache, fatigue and
body aches. In general, these types of
self-limited reactions
are reported more frequently than with MenACWY
vaccination. |
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| What are the
contraindications and precautions for MenB? |
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| As with all
vaccines, a severe allergic reaction (for
example, anaphylaxis) to a vaccine component
or to a prior dose is a contraindication to
further doses
of that vaccine. The tip caps of the Bexsero
pre-filled syringes contain natural rubber
latex which may cause allergic reactions in
latex sensitive individuals.
A moderate or severe acute illness is a
precaution; vaccination should be deferred
until the person’s condition has improved.
Because MenB is an
inactivated vaccine it can be administered to
persons who are immunosuppressed as a result
of disease or medications; however, response
to the vaccine
might be less than optimal. Data on MenB
vaccination during pregnancy is limited.
Pregnancy a precaution to MenB vaccination,
but MenB may be
administered if, in the judgment of the
clinician, the benefits outweigh any potential
risks. |
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| Should a
pregnant woman receive MenB vaccine? |
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| Few data are
available on the effect of MenB vaccines on
pregnancy. The manufacturers do not consider pregnancy to be a contraindication to use of
MenB. GSK has established a Vaccination in
Pregnancy registry. Women who receive Bexsero
during pregnancy are encouraged to participate
in the
registry by calling 877-683-4732. Pfizer also
maintains a Vaccination in Pregnancy registry
for Trumenba, although specific contact
details for this
registry are not available. No data are
available from these registries. In general,
vaccination against MenB should be deferred
during pregnancy;
however, MenB may be administered if, in the
judgment of the clinician, the benefits
outweigh any potential risk. |
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| Vaccine Storage and Handling |
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| What is the
storage requirements for MenB? |
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| Store at MenB at
refrigerator temperature, between 2° and 8°C
(between 36° and 46°F). The vaccines must not
be frozen. Vaccine that has been frozen
or exposed to freezing temperature should not
be used. Do not use after the expiration date. |
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ACIP Recommendations
Vaccine Information Statements 
