Common And Local Adverse Events
Conjugate meningococcal vaccines
Injection site reactions occur in up to 59% of vaccinees. Fever is reported in up to 5% of recipients and systemic reactions, such as headache and malaise, are reported in up to 60% of recipients.
Mild reactions, including injection site reactions , occur in up to 50% of vaccine recipients. Irritability occurs in up to 80% of infants and fever in up to 9% when other vaccines were administered. Headaches and malaise occur in up to 10% of older children and adults. These reactions last no more than a few days.
Serogroup B Meningococcal vaccines
Solicited local and systemic reactions have been commonly reported in clinical trials and include injection site tenderness, induration, sleepiness and irritability. Higher rates of fever have been observed with simultaneous administration of 4CMenB vaccine and routine infant vaccines therefore, routine prophylactic administration of acetaminophen or separating 4CMenB vaccination from routine vaccination schedule has been proposed for preventing fever in infants and children up to three years of age.
Solicited local and systemic reactions have been commonly reported in clinical trials and include injection site tenderness, induration and irritability.
How Is Meningococcal Disease Spread And Who Is Most At Risk
Meningococcal disease is not as contagious as other illnesses, such as a cold or the flu. But it is spread by contact with infected respiratory and throat secretions. That can happen with coughing, kissing, or sneezing.
Because the risk increases with close or prolonged contact with an infected person, family members in the same household and caregivers are at an increased risk. For the same reason, so are college students who live in dormitories.
Countries Where Both Meningococcal Quadrivalent Polysaccharide And Quadrivalent Polysaccharide
There are two meningococcal vaccines available in the United States, MC-4 and MPS-4 and The Advisory Committee on Immunization Practices has published recommendations on their use.128 These vaccines as well as monovalent group C conjugate vaccines are also available in Canada. Selected properties of these vaccines are shown in Table 19-4. MPS-4 vaccine can be given both to adults and to children 2 years of age and over, whereas as of July 2006, MC-4 was recommended in the U.S. only for 1155-year-olds. However, in Canada MC-4 vaccine is also licensed for use in children 210 years of age. Routine MPS-4 vaccination of civilian populations is not recommended, primarily because of limited effectiveness in young children, the age group at greatest risk of acquiring disease, and minimal if any effect on decreasing N. meningitidis nasopharyngeal carriage in the population.
MC-4 vaccine elicits serum bactericidal antibodies of superior quality and persistence than those elicited by MPS-4 vaccine and there also is the potential for vaccination to decrease meningococcal carriage. Therefore, once MC-4 vaccine was licensed in the U.S. for persons 11 to 55 years, there was the potential to introduce routine meningococcal vaccination into the general population. The ACIP recommended routine immunization of adolescents at 11-12 years of age or, if not given at that age, before starting high school128. College freshmen living in dormitories also should receive vaccine.
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Effectiveness Of The Menb Vaccine
Another type of meningococcal vaccine is the MenB vaccine, which protects against a fifth strain of Neisseria meningitidis. In the U.S., parents can opt to give their children a MenB vaccine once theyre in their teens.
The CDC’s analysis of the efficacy of the MenB vaccines in the real world comes from studies done in other countries. In Canada, a study followed a mass vaccination campaign in a region with a meningitis B outbreak and found that a MenB vaccine was 79% effective in the four years after vaccination.
In the UK, MenB vaccines have become part of the childhood immunization schedule. By 2018 as many as 92% of eligible infants in the UK completed a MenB vaccination by their first birthday, according to a 2020 study in The New England Journal of Medicine.
That study estimated that the vaccine was about 53% effective. This policy has also resulted in a large drop in meningitis B cases. The study noted a 75% drop in cases among vaccine-eligible age groups, compared to the expected numbers.
Is Meningococcal Disease Serious
Meningococcal meningitis and bloodstream infections can be very serious, even deadly. The infections progress quickly. Someone can go from being healthy to very ill in 48 hours or less. Even if they get treatment, about 10 to 15 out of 100 people with meningococcal disease will die from it. Long-term disabilities from having meningococcal disease include loss of limbs, deafness, nervous system problems, and brain damage.
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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.
A Meningococcal Capsular Group A Conjugate Vaccine For Africa
For the past two decades, the only meningococcal vaccines available in sub-Saharan Africa were a bivalent group A and C and a trivalent group A, C, and W135 polysaccharide vaccine . These vaccines are poorly immunogenic in infants, the age group at greatest risk of acquiring disease, and have only a transient effect, if any, on colonization and spread of infection. For these reasons, meningococcal vaccination in Africa was largely done in response to epidemics, which was a logistically challenging strategy. Although an emergency response plan had been developed in collaboration with the WHO and the CDC,436 implementation was often delayed because of limitations of surveillance or logistics. One study estimated that even under optimal circumstances, fewer than 60% of outbreak-related cases were prevented by implementing vaccination after an epidemic was recognized.436 An improved meningococcal vaccine, therefore, was needed.
In , 2016
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Which Meningococcal Vaccines Are Available
In the U.S., three meningococcal vaccines are available:
- Meningococcal polysaccharide vaccine , sold as Menomune
- Meningococcal conjugate vaccine , sold as Menactra, MenHibrix, and Menveo.
- Serogroup B meningococcal vaccine, sold asTrumenba and Bexsero.
MPSV4 and MCV4 can prevent four types of meningococcal disease, which make up about 70% of the cases in the U.S.
The MenB vaccines prevent the Meningococcal B strain.
MCV4 is preferred for people age 55 and younger. The recommendation for teens is one dose at age 11 and one dose at age 16. The doctor or nurse injects one dose into the muscle. If MCV4 is not available, you can use MPSV4. The doctor or nurse injects one dose beneath the skin.
MPSV4 is the only meningococcal vaccine approved for use in people over 55.
The MenB vaccines are recommended for ages 10-24, by the CDC for high risk patients, but can also be used in older adults. Trumenba is administered in three doses while Bexsero requires two doses.
Healthy Infants And Children
One dose of Men-C-C vaccine is recommended in unimmunized children less than 5 years of age. One dose of Men-C-C vaccine may be considered for children 5 to 11 years of age if they have not previously been immunized as infants or toddlers. Immunization with 4CMenB vaccine or MenB-fHBP may be considered on an individual basis, depending on individual preferences, regional serogroup B epidemiology and strain susceptibility.
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Special Considerations For Use Of Menactra For People With Functional Or Anatomic Asplenia Or Hiv
Children with functional or anatomic asplenia or HIV should not receive Menactra® before the age of 2 years. This timing avoids interference with the immunologic response to the infant series of pneumococcal conjugate vaccine . CDC recommends infants 2 through 23 months of age with functional or anatomic asplenia or HIV receive Menveo®.
People 2 years of age or older with functional or anatomic asplenia or HIV should not receive Menactra® at the same time as PCV. They should either receive Menveo® or MenQuadfi® when they get PCV or wait and receive Menactra® 4 weeks after completion of all PCV doses.
Guidance On Reporting Adverse Events Following Immunization
To ensure the ongoing safety of vaccines in Canada, reporting of AEFIs by vaccine providers and other clinicians is critical, and in some jurisdictions, reporting is mandatory under the law.
Vaccine providers are asked to report AEFIs, through local public health officials, and to check for specific AEFI reporting requirements in their province or territory. In general, any serious or unexpected adverse event felt to be temporally related to vaccination should be reported.
For additional information about AEFI reporting, please refer to Adverse events following immunization. For general vaccine safety information, refer to Vaccine safety and pharmacovigilance in Part 2.
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What Are The Side Effects
About half of people who get a MenACWY vaccine have mild side effects following vaccination:
- Redness or pain where they got the shot
These reactions usually get better on their own within 1 to 2 days, but serious reactions are possible.
Following a MenB shot, more than half of people who get the vaccine will have mild problems:
- Soreness, redness, or swelling where you got the shot
Who Should Get Meningococcal Vaccines
CDC recommends meningococcal vaccination for all preteens and teens. In certain situations, CDC also recommends other children and adults get meningococcal vaccines. Below is more information about which meningococcal vaccines, including booster shots, CDC recommends for people by age.
Talk to your or your childs doctor about what is best for your specific situation.
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What Are The Side Effects Of Meningococcal Vaccines
Mild side effects happen in about half those who get the vaccine. They may include redness or pain where the skin was injected. These side effects last no longer than 1 or 2 days.
Serious side effects are rare and can include high fever, weakness, and changes in behavior.
Severe allergic reactions may happen within minutes or hours of having the vaccination. These are signs of an allergic reaction:
Where And When Can I Get The Vaccine
Talk to your doctor or local public health clinic to find out where and when your child should get vaccinated.
- The cost of Men-C-C is covered everywhere in Canada.
- Many provinces currently cover the cost of MCV-4 vaccine.
- Currently, no provinces or territories cover the cost of Men-B vaccine for all children. Some provide it for children at high risk of getting meningococcal disease.
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Ingredients In Menb Vaccines
Meningitis B vaccines, like Bexero and Trumenba, are made up of three proteins found on the surface of one subtype of the Neisseria meningitidis bacteria. The specific proteins differ, depending on whether you receive Bexsero or Trumenba.
These vaccine contains very small amounts of other ingredients, like aluminum hydroxide, sucrose , histidine , and sodium chloride .
Menb Vaccination Of Adults At Increased Risk
MenB vaccines are not approved for use in people under 10 years old. Adults should receive a MenB vaccine if they are at increased risk for serogroup B meningococcal disease due to
- Having certain medical conditions
- Complement component deficiency
- Functional or anatomic asplenia
Those who remain at increased risk need regular booster doses.
- Administer a booster dose of MenB vaccine 1 year after series completion and then every 2 to 3 years thereafter.
- For those at increased risk due to an outbreak who previously received the MenB vaccine series, CDC recommends a booster dose if a year or more has passed since primary series completion.
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Before Taking This Medicine
You may not be able to receive this vaccine if you’ve ever had an allergic reaction to a meningococcal, diphtheria, or tetanus vaccine.
This vaccine may need to be postponed or not given at all if you have:
a severe illness with a fever or any type of infection
a weak immune system caused by disease or by using certain medicine
a history of Guillain-Barré syndrome or
a history of premature birth.
You can still receive a vaccine if you’ve a minor cold.
Your doctor should determine whether you need this vaccine during pregnancy or while breastfeeding.
Why Do Teens Need A Meningococcal Vaccine
Of the 1,000-2,600 people who get meningococcal disease each year, one-third are teens and young adults. Ten percent to 15% of those who get sick with the disease will die, even with antibiotic treatment. As many as 20% of the survivorswill have permanent side effects, such as hearing loss or brain damage.
The immunization can help prevent this serious disease.
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How Can I Protect My Child
There are three kinds of meningococcal vaccine available in Canada. Each vaccine provides different protection:
- Meningococcal C vaccine is usually given to babies and young children. It protects against type C of the meningococcus germ, which used to be very common before this vaccine was available.
- MCV-4 protects against 4 types of the meningococcal germ . This vaccine is usually only given to people at higher risk of getting meningococcal disease . In some provinces it is given to all teenagers.
- Meningococcal B vaccine protects children against type B. This vaccine is not given routinely but is usually given to children at higher risk of getting meningococcal disease.
Your doctor will know which vaccine is best for your child, and at what age.
What Are The Possible Side Effects Of Meningococcal Vaccines
Some of the most common side effects are swelling, redness, and pain at the site of the injection, along with headache, fever, or tiredness. Serious problems, such as allergic reactions, are rare.
The meningococcal vaccines contains only a small piece of the germ, so it can’t cause meningococcal disease.
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More Information On Side Effects
Reactions listed under possible side effects or adverse events on vaccine product information sheets may not all be directly linked to the vaccine. See Vaccine side effects and adverse reactions for more information on why this is the case.
If you are concerned about any reactions that occur after vaccination, consult your doctor. In the UK you can report suspected vaccine side effects to the Medicines and Healthcare products Regulatory Agency through the Yellow Card Scheme . See more information on the Yellow Card scheme and monitoring of vaccine safety.
High Risk Groups For Meningococcal Disease
Other people are not funded under the National Immunisation Program and will require a prescription to purchase the meningococcal vaccines. If you are in one of the following high-risk groups, speak to your doctor about which vaccines you should have, the number of doses required and how long protection will last:
- infants and young children, particularly those aged less than two years
- adolescents aged 15 to 19 years
- people who have close household contact with those who have meningococcal disease and who have not been immunised
- people who smoke and are aged 15 to 24 years
- people who are travelling to places, such as sub-Saharan Africa, that have epidemics caused by serogroups A, C, W and Y
- pilgrims to the annual Hajj in Saudi Arabia Saudi Arabian authorities require a valid certificate of vaccination to enter the country
- people who work in a laboratory and who handle meningococcal bacteria
- people with HIV
- people who have had a haematopoietic stem cell transplant.
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What To Think About
The menigococcal vaccine can be given at the same time as other routine childhood vaccinations.
The conjugate meningococcal vaccines may be used during pregnancy when the benefits of getting the vaccine outweighs the risk.
The conjugate and multi-component vaccines may be given to women who are breastfeeding.
No evidence has shown that Canadian university students who live in dormitories or residence halls are at higher risk of getting meningococcal disease.footnote 2
Who Should Get Immunised Against Meningococcal Disease
Anyone who wants to protect themselves against meningococcal disease can talk to their doctor about getting immunised.
Anyone wishing to reduce their risk of meningococcal disease can be offered vaccination with meningococcal B and meningococcal ACWY from as early as 6 weeks of age.
Meningococcal immunisation is recommended for:
- babies and young children under 2 years old
- teenagers and young adults aged 15-19 years
- teenagers and young adults aged 15 to 24 years living together in close quarters, such as dormitories and military barracks
- Aboriginal and Torres Strait Islander people aged 2 months to 19 years
- teenagers and young adults aged 15 to 24 years who are current smokers
- people who are travelling overseas to places where meningococcal disease is more common, or people travelling to mass gatherings like the Hajj ,
- people who have medical conditions that increase their risk of invasive meningococcal disease for example, people who have certain blood disorders, or are taking treatment for certain blood disorders people with weakened immune systems, such as people without a functioning spleen, people living with HIV and people who have had a stem cell transplant
- laboratory workers who work with the bacterium that causes meningococcal disease
Speak to your doctor or vaccination provider for advice or refer to the meningococcal recommendations in the Australian Immunisation Handbook for more information and list of medical conditions.
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