Initial U.S. Approval: 2015
BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B… for use in individuals aged 10 through 25 years.
[S]evere myalgia… was reported by 3% to 7% of subjects. Severe pain was reported by 8% of university students…
2.1%… reported serious adverse events.
Postmarketing Experience
– Lymphadenopathy.
– Injection site reactions (including extensive swelling of the vaccinated limb, blisters at or around the injection site, and injection site nodule which may persist for more than 1 month).
– Allergic reactions (including anaphylactic reactions), rash, eye swelling.
– Syncope, vasovagal responses to injection.
Each 0.5-mL dose of BEXSERO is formulated to contain 50 micrograms each of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), 25 micrograms of Outer Membrane Vesicles (OMV), 1.5 mg aluminum hydroxide (0.519 mg of Al3+ [aluminum]), 3.125 mg sodium chloride, 0.776 mg histidine, and 10 mg sucrose at pH 6.4 – 6.7.
3 recombinant proteins are individually produced in Escherichia coli [E.coli]…
BEXSERO has not been evaluated for carcinogenic or mutagenic potential or impairment of male fertility in animals.