Bexsero (Meningococcal Group B Vaccine)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved January 2015

Specific Treatments:

invasive meningococcal disease caused by serogroup B

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General Information

Bexsero is a multicomponent Meningococcal Serogroup B vaccine.

Bexsero is specifically indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Bexsero is approved for use in individuals 10 through 25 years of age.

Bexsero is supplied as a solution for intramuscular administration. Bexsero should be administer in two doses (0.5 mL each) at least 1 month apart.

Clinical Results

FDA Approval

The FDA approval of Bexsero was based on three studies conducted in Canada, Australia, Chile, and the United Kingdom in approximately 2,600 adolescents and young adults. Among subjects who received two doses of Bexsero, after vaccination, 62 to 88% had antibodies in their blood that killed three different N. meningitidis serogroup B strains in tests carried out in a laboratory, compared with 0 to 23% before vaccination. These three strains are representative of strains that cause serogroup B meningococcal disease in the U.S.

Side Effects

Adverse effects associated with the use of Bexsero may include, but are not limited to, the following:

  • pain at the injection site
  • myalgia
  • erythema
  • fatigue
  • headache
  • induration
  • nausea
  • arthralgia

Mechanism of Action

Bexsero is a multicomponent Meningococcal Serogroup B vaccine. NHBA, NadA, fHbp, and PorA are proteins found on the surface of meningococci and contribute to the ability of the bacterium to cause disease. Vaccination with Bexsero leads to the production of antibodies directed against NHBA, NadA, fHbp, and PorA P1.4. The susceptibility of serogroup B meningococci to complement-mediated antibodydependent killing following vaccination with Bexsero is dependent on both the antigenic similarity of the bacterial and vaccine antigens, as well as the amount of antigen expressed on the surface of the invading meningococci.

Additional Information

For additional information regarding Bexsero or invasive meningococcal disease caused by serogroup B, please visit http://www.bexsero.com/