Cdc Does Not Routinely Recommend Menb Vaccination For All Adolescents
Vaccine providers may choose to administer a MenB vaccine to adolescents and young adults 16 through 23 years of age. The preferred age at which to administer the vaccine is 16 through 18 years old.
Together, clinicians and patients or their parents can determine if MenB vaccination is appropriate for them. Clinicians, parents, teens, and young adults may want to consider the following when making this decision:
Persons With Inadequate Immunization Records
Children and adults lacking adequate documentation of immunization should be considered unimmunized and started on an immunization schedule appropriate for their age and risk factors. Conjugate meningococcal vaccine, as appropriate for age, may be given regardless of possible previous receipt of the vaccine, as adverse events associated with repeated immunization have not been demonstrated. Refer to Immunization of persons with inadequate immunization records in Part 3 for additional general information.
Who Needs A Meningococcal Vaccine
The CDC recommends a meningococcal vaccine for:
- All children ages 11-18 or certain younger high-risk children
- Anyone who has been exposed to meningitis during an outbreak
- Anyone traveling to or living where meningitis is common, such as in sub-Saharan Africa
- Military recruits
- People with certain immune system disorders or a damaged or missing spleen
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Cdc Recommends Meningococcal Vaccination For People Identified As Being At Increased Risk During Outbreaks
CDC supports state and local health departments in investigating outbreaks and implementing outbreak control measures. During a serogroup A, C, W, or Y meningococcal disease outbreak, CDC recommends MenACWY vaccination for people at increased risk because of the outbreak. During a serogroup B meningococcal disease outbreak, CDC recommends MenB vaccination for people at increased risk because of the outbreak. People who have previously received MenACWY or MenB vaccine and become at increased risk because of an outbreak may be recommended to receive a booster dose depending on how long it has been since they previously received the vaccine.
Meningitis B Is A Killer
Meningococcal group B bacteria are a serious cause of life-threatening infections worldwide, including meningitis and .
They’re also the leading infectious killer of babies and young children in the UK.
There are 12 known groups of meningococcal bacteria, and group B is responsible for about 9 in every 10 meningococcal infections in the UK.
Meningitis and sepsis caused by meningococcal group B bacteria can affect people of any age but are most common in babies and young children.
While most young children recover from MenB, around 1 in 20 die from the infection.
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Conjugate Vaccine Carrier Proteins
Protein conjugates used in Hib conjugate vaccines produced in the United States include tetanus toxoid which is also used as a component of DTaP and Tdap vaccines . Simultaneous or sequential vaccination with Hib and these tetanus-toxoid containing vaccines is recommended when both are indicated . MCV4 and PCV13 both contain diphtheria-toxoid conjugates. There has been concern about simultaneous administration of vaccines containing like conjugates. One brand of MCV4, MenACWY-D , demonstrates reduced immunogenicity of the antibody response to Streptococcal pneumonia strains when administered simultaneously with PCV13 compared with separate administration. It is recommended to space these vaccines by 28 days in a person with anatomic asplenia . Simultaneous or sequential vaccination of MCV4-CRM , PCV13, and Tdap , all of which contain diphtheria toxoid, is not associated with reduced immunogenicity or increase in local adverse events.
Simultaneous Administration With Other Vaccines
Men-C-C and 4CMenB vaccine may be administered concomitantly with routine childhood vaccines, and Men-C-ACYW vaccine may be administered concomitantly with adolescent and adult age appropriate vaccines. MenB-fHBP can be given concomitantly with quadrivalent human papillomavirus vaccine meningococcal serogroup A, C, Y, W conjugate vaccine and tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed. The concomitant administration of MenB-fHBP has not been studied with other vaccines.
Men-C-ACYW-CRM can be administered with routine paediatric vaccines however, further studies are needed with regard to concomitant administration with pneumococcal 13-valent conjugate vaccine. Co-administration of Men-C-ACYW-CRM and combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine may result in a lower immune response to the pertussis antigens than when Tdap vaccine is given alone however, the clinical significance of this is unknown. Tdap vaccine given one month after Men-C-ACYW-CRM induces the strongest immunologic response to pertussis antigens.
If vaccines are to be administered concomitantly with another vaccine, a separate injection site and a different syringe must be used for each injection.
Refer to Timing of Vaccine Administration in Part 1 for additional general information.
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Before You Or Your Child Receives Bexsero
Tell your doctor or pharmacist if you have/your child has allergies to:
- active substances or any of the other ingredients of BEXSERO
- the antibiotic kanamycin. If present, the kanamycin level in the vaccine is low
- latex. Although no natural rubber latex is detected in the syringe tip cap, the safe use of BEXSERO in latex-sensitive individuals has not been established.
Tell your doctor if in the past you or your child have/has reacted to any vaccination with any of the following:
- severe allergic reaction
- difficulty breathing
- swelling of the throat
Tell your doctor if you have/your child has a severe infection with a high temperature. If this is the case, then vaccination will be postponed. The presence of a minor infection, such as a cold, should not require postponement of the vaccination, but talk to your doctor first.
Tell your doctor if you receive treatment that blocks the part of the immune system known as complement activation, such as eculizumab. Even if you have been vaccinated with BEXSERO you remain at increased risk of disease caused by the Neisseria meningitidis group B bacteria.
If your child was born prematurely , particularly if they had breathing difficulties, please tell your doctor. Stopping breathing or irregular breathing for a short time may be more common in the first three days following vaccination in these babies and they may need special monitoring.
Tell your doctor or nurse if you have experienced this kind of reaction previously
Fever And Local Vaccine Responses
Fever is part of a robust immune system response to Bexsero, usually peaking around 6 hours after vaccination and settling over 2448 hours. A fever over 38°C is more likely to occur in infants and children aged under 2 years after vaccination with Bexsero compared with other routinely used infant vaccines. When Bexsero is administered at the same visit as other Immunisation Schedule vaccines, a fever over 38°C or 39°C is almost twice as likely as when the Immunisation Schedule vaccines are given alone.
Similarly, redness, swelling and/or mildmoderate pain around the injection site are also common expected immune responses to Bexsero, peaking on the day of vaccination followed by a significant decrease, and settling from around 24 hours after vaccination.
Recommendation for use of prophylactic paracetamol
The advice for the use of prophylactic paracetamol for children aged under 2 years only applies to immunisation events when Bexsero is administered, either as the only vaccine or with other vaccines. This is because of the evidence of a robust immune response to Bexsero in young children and that the use of prophylactic paracetamol around fever over 39°C, and injection site pain. Some infants will still develop a fever and/or injection site pain even though they have received paracetamol doses.
Ibuprofen may be given as an alternative to paracetamol.
Non-pharmaceutical management of fever or injection site pain
Bexsero should not be given to:
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Bexsero Should Not Be Given To A Person Who Has:
- allergy to the active substances or any of the other ingredients of BEXSERO listed at the end of this leaflet. Signs of an allergic reaction may include:- shortness of breath, wheezing or difficulty breathing,- swelling of the face, lips, tongue or other parts of the body,- skin rash, itching or hives
In addition, BEXSERO should not be administered if:
- the expiry date printed on the pack has passed
- the packaging is torn or shows signs of tampering.
If you are not sure whether you or your child should have BEXSERO, talk to your doctor, nurse or pharmacist.
Number And Timing Of Doses
Vaccinate all children younger than 2 years old with PCV13. The primary series consists of 3 doses routinely given at 2, 4, and 6 months of age. You can administer the first dose as early as 6 weeks of age. CDC recommends a fourth dose at 12 through 15 months of age. For children vaccinated when they are younger than 12 months of age, the minimum interval between doses is 4 weeks. Separate doses given at 12 months of age and older by at least 8 weeks.
The number and timing of doses for older children and adults depends on the medical indication, prior pneumococcal vaccination, and age. See Pneumococcal Vaccination: Summary of Who and When to Vaccinate for all pneumococcal vaccine recommendations by vaccine and age.
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Extra Doses Of Vaccine Antigens
Administering extra antigens contained in a combination vaccine should be avoided in most situations . Using combination vaccines containing certain antigens not indicated at the time of administration to a patient might be justified when 1) the extra antigen is not contraindicated, 2) products that contain only the needed antigens are not readily available, and 3) potential benefits to the patient outweigh the potential risk for adverse events associated with the extra antigens. An extra dose of many live-virus vaccines and Hib or hepatitis B vaccine has not been found to be harmful . However, the risk for an adverse event might increase when extra doses are administered at an earlier time than the recommended interval for certain vaccines .
A vaccination provider might not have vaccines available that contain only the antigens needed as indicated by a childs vaccination history. Alternatively, although the indicated vaccines might be available, the provider might prefer to use a combination vaccine to reduce the required number of injections. In such cases, the benefits and risks of administering the combination vaccine with an unneeded antigen should be carefully considered and discussed with the patient or parent.
Persons New To Canada
Health care providers who see persons newly arrived in Canada should review the immunization status and update immunization for these individuals. Review of meningococcal vaccination status is particularly important for persons from areas of the world where sickle cell disease is present as persons with sickle cell disease are at risk of serious meningococcal infections. In many countries outside of Canada, conjugate meningococcal vaccines are in limited use. Information on vaccination schedules in other countries can be found on the World Health Organization website. Refer to Immunization of Persons New to Canada in Part 3 for additional general information.
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People With Certain Medical Conditions Need A 2
Vaccinate people with the following medical conditions with a 2-dose primary series of MenACWY vaccine administered 8 weeks apart:
- Complement component deficiency
- Functional or anatomic asplenia
Administer routine booster doses every 5 years throughout life to people with these medical conditions. Booster doses will help these patients maintain protection against meningococcal disease.
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.
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Adult Studies On Concomitant Administration
Nine concomitant meningococcal vaccine studies performed in adults are summarized in Table 2.52,68,76–82 All of these studies also included individuals 25 years of age however, results were not reported by age subgroup, and all adult studies lacked the focus on adolescents and/or young adults that characterized the studies described previously. As for the adolescent and young adult studies, safety findings from adult studies were generally unremarkable 68,76–82 exceptions are noted in the following sections where applicable.
Meningococcal protein vaccines with meningococcal conjugate vaccines
A small single-arm study assessed the coadministration of MenB-4C and MenACWY-CRM in laboratory workers.82 Of note, MenB-4C is generally administered as 2 doses given 1 month apart.44 Although the first respective doses of MenB-4C and MenACWY-CRM were administered together, there was no comparator group included in this analysis and therefore immune interference was not systematically assessed. High rates of baseline immunity were observed, which increased following vaccination the highest rSBA GMTs for groups A, C, and Y were measured at month 3 .82
Safety findings from this study indicated higher rates of nausea and headache when MenACWY-CRM and MenB-4C were administered concomitantly than when MenB-4C was administered alone at subsequent vaccination visits.82
Meningococcal conjugate vaccines with non-meningococcal vaccines
How It Is Given
BEXSERO is given as an injection, usually into your or your child’s arm or leg muscle.
It is important to follow the instructions from your doctor or nurse so that you or your child completes the course of injections.
If you have any concerns about how this vaccine is to be given, talk to your doctor, nurse or pharmacist.
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Menb Vaccines Require Multiple Doses
Both MenB vaccine products require more than 1 dose for maximum protection. Adolescents must receive the same vaccine product for all doses.
- Bexsero:® Administer 2 doses. Administer the second dose at least 1 month after the first dose.
- Trumenba:® Administer 2 or 3 doses.
- Administer 2 doses to healthy adolescents who are not at increased risk for serogroup B meningococcal disease. Administer the second dose 6 months after the first dose.
- Administer 3 doses to adolescents who are at increased risk for meningococcal disease. This includes during outbreaks of serogroup B meningococcal disease. Administer the second dose 1 to 2 months after the first dose. Administer the third dose 6 months after the first dose.
Interchangeability Of Combination Vaccines From Different Manufacturers
Licensure of a vaccine by FDA does not necessarily indicate that the vaccine is interchangeable with products from other manufacturers. Such data are ascertained and interpreted more readily for diseases with known correlates of protective immunity . For diseases without such surrogate laboratory markers, prelicensure field vaccine efficacy trials or postlicensure surveillance generally are required to determine protection . ACIP prefers that doses of vaccine in a series come from the same manufacturer however, if this is not possible or if the manufacturer of doses given previously is unknown, providers should administer the vaccine that they have available.
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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.
Proper Use Of Bexsero
This section provides information on the proper use of a number of products that contain meningococcal vaccine. It may not be specific to Bexsero. Please read with care.
A nurse or other trained health professional will give this vaccine to you or your child. It is given as a shot under your skin or into one of your muscles.
Trumenba®: An injection is given into a muscle. It is very important for you or your child to receive all of the shots for the vaccine.
- Two-dose schedule: Given at least 6 months apart . If the second dose is given earlier than 6 months after the first dose, you will receive a third dose at least 4 months after the second dose.
- Three-dose schedule: After you receive the first dose , you will receive a second dose after 1 to 2 months. The third dose is given 6 months after the first dose.
Bexsero®: An injection is given into a muscle. Two doses, each given at least 1 month apart. It is very important for you or your child to receive all of the 2 shots for the vaccine.
Menomune®: One dose injected under the skin. Usually a person needs to receive the vaccine only once. However, additional injections may be needed for young children who remain at high risk for meningococcal disease.
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Side Effects Of The Menb Vaccine
Babies given the MenB vaccine alongside their other routine vaccinations at 8 and 16 weeks are likely to develop a high temperature within 24 hours of vaccination.
It’s important to give your baby liquid paracetamol following vaccination to reduce this risk. Your nurse will advise you about using children’s paracetamol at your vaccination appointment.
Other common side effects of the MenB vaccine include:
- pain, swelling or redness where the injection was given
- diarrhoea or being sick
- crying and irritability
The liquid paracetamol will also help with these symptoms.
An allergic reaction is a rare side effect of the MenB vaccine. This may be a rash or itching that affects part or all of the body.
Very rarely, a baby may have a severe allergic reaction after having the MenB vaccine.