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What are the adverse effects of MenB vaccines?

CAROLE MOLONEY, RN, MSN, CPNP

credit: Juanmonino/Getty Images

Health care providers need to be talking with their patients and families about meningococcal group B (MenB) disease and vaccination.

Any contact between a health care provider and patients is an opportunity to review the patient’s immunization status and deliver the recommended vaccines. In fact, the health care provider’s recommendation is associated with an improved uptake of vaccines.


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Of course, anytime there is a conversation about vaccines, the most frequently asked questions are, “Will it hurt? What are the side effects? And do I need it?”

The answer to the first question is “Yes, it will hurt, it’s a shot.” The answer to the second question is more specific to which vaccine is being used, but pain at the injection site is the most common reported side effect for both vaccines. Lastly, the indication is either for a specific high-risk condition or to provide wanted protection. The discussion that ensues is part of the specific conversation that happens with each patient and family.

It is important to familiarize yourself with the vaccine that is used in your practice. Your personal and professional experience with the vaccine as the provider is important to be able to share with your patients. 

There are two currently licensed MenB vaccines available in the United States. They were licensed based on immunogenicity (the ability to elicit bactericidal activity). Both vaccines were licensed by the Food and Drug Administration in 2014-2015 for use in persons aged 10-25 years. There are specific indications for the vaccine based on Category A (high-risk patients and situations) and Category B (healthy adolescents) as outlined by the Advisory Committee on Immunization Practices. 

Carole Moloney

It is important to familiarize yourself with the vaccine that is used in your practice. Your personal and professional experience with the vaccine as the provider is important to be able to share with your patients. 

There are two currently licensed MenB vaccines available in the United States. They were licensed based on immunogenicity (the ability to elicit bactericidal activity). Both vaccines were licensed by the Food and Drug Administration in 2014-2015 for use in persons aged 10-25 years. There are specific indications for the vaccine based on Category A (high-risk patients and situations) and Category B (healthy adolescents) as outlined by the Advisory Committee on Immunization Practices. 

As the Centers for Disease Control and Prevention’s 2016 Enhanced Meningococcal Disease Surveillance Report shows, infants accounted for 20% of total MenB cases in the Unites States, compared with 32% for adolescents and young adults. Children aged 1-4 years represent 12% of cases, while those aged 5-10 years make up 4%.

The two vaccines use different strategies to elicit broad protection. The vaccines are not interchangeable.

GlaxoSmithKline manufactures Bexsero, which is a MenB-4C vaccine. It has four components: factor H binding protein from subfamily B, Neisseria heparin binding antigen fusion protein, Neisserial adhesin A fragment, and outer membrane vesicles containing PorA. 

Pfizer manufactures Trumenba, which is a MenB-FHbp vaccine; it contains lipidated factor H binding protein from subfamily A and subfamily B.

The tip caps of the Bexsero prefilled syringes contain natural rubber latex, which may cause allergic reactions in latex sensitive individuals. No mercury is contained in either vaccine.

More than half of the people who get a MenB vaccine have mild problems following vaccination, which can last 3-7 days.

For MenB-4C, the most reported side effect was pain at the injection site (greater than or equal to 83%), followed by myalgia (greater than or equal to 48%), erythema (greater than or equal to 45%), fatigue (greater than or equal to 35%), headache (greater than or equal to 33%), induration (greater than or equal to 28%), nausea (greater than or equal to 18%), and arthralgia (greater than or equal to 13%), according to clinical trials data.

The most common reactions for MenB-FHbp were pain at the injection site (greater than or equal to 85%), fatigue (greater than or equal to 40%), headache (greater than or equal to 35%), myalgia (greater than or equal to 30%), and chills (greater than or equal to 15%), according to clinical trials data.

Serious adverse events associated with both vaccines are rare. However, when dealing with adolescents and young adults, it’s important to remember that sometimes people faint following the administration of a vaccine. Sitting or lying down for 15 minutes can help prevent fainting and a potential injury from a fall.

Always remember to review the side effects of the vaccine and make sure the patient and family receive the Vaccine Information Statement fact sheet from the CDC, which is an excellent reference. The family should have the practice number to call with any questions or concerns. If another dose of vaccine is necessary to complete the series, remind them that one dose is not enough and schedule the follow-up appointment before they leave the office.

Of note, in February 2018, Bexsero received breakthrough therapy designation from the FDA for prevention of invasive meningococcal disease in children aged 2-10 years.

On April 23, 2018, Pfizer announced that Trumenba received breakthrough therapy designation from the FDA for active immunization to prevent invasive disease caused by Neisseria meningitidis group B in children aged 1-9 years.

Breakthrough therapy designation is given to speed up the development and review of drugs and vaccines that are meant to treat or prevent serious conditions and have early clinical evidence demonstrating that the drug or vaccine may show considerable improvement over available therapy. According to the FDA website, drugs and vaccines that receive this designation are eligible for all features of the FDA’s fast track designation, such as more frequent communication with the FDA about the drug’s development plan and qualifications for accelerated approval and priority review if appropriate criteria are met.

Carole Moloney is a certified pediatric nurse practitioner in the division of pediatric infectious diseases at Boston Medical Center.