At the end of January, the FDA announced approval for Bexsero, a Novartis vaccine designed to protect against invasive meningococcal disease caused by the serogroup B bacteria, Neisseria meningitidis.
The product labeling indicates it is for use with adolescents and young adults between the ages of 10 and 25.
A company spokesperson said the vaccine should be available in the United States at some point during the first quarter of 2015.
Patients should receive the two 0.5 mL doses administered intramuscularly at least one month apart. Younger patients may wait for two months or more before receiving the second injection. Infants between two and five months will receive three injections at intervals of at least one month. Children under the age of two will receive an additional booster at a later point in time determined by age. It has yet to be determined whether Bexsero and other meningococcal group B vaccines can be interchanged to complete a vaccination series.
During clinical trials, most recipients reported side effects including injection site pain, and redness. Other injection site reactions were common. Other frequently reported side effects included joint pain, nausea, headache, and fatigue.
The medication will be available in 0.5 mL prefilled glass syringes and packaged in cartons containing nine or 10 of each. The product should be kept refrigerated anywhere between 2° and 8°C, or 35.6° and 46.4°F, and never frozen.
Though the syringe caps contain natural rubber latex, the plungers do not, so this should not be an issue for anyone with the latex allergy.
The Centers for Disease Control and Prevention (CDC) says meningococcal disease is rare in the United States, but if and when it occurs it can be deadly or disabling. Meningococcal serogroup B, C, and why bacteria are the major causes of meningococcal disease within the United States. Each serogroup accounts for about one third of U.S. cases.
One of the Healthy People 2020 goals is to reduce the incidence of meningococcal disease to 0.3 cases per 10,000 people. During 2013, the incidence was 0.13 cases per 100,000 people according to the CDC. This vaccination is step in the right direction toward accomplishing this goal.
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