What Is Bexsero?
Bexsero (Meningococcal Group B Vaccine) is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitides serogroup B. Bexsero is approved for use in individuals 10 through 25 years of age.
What Are Side Effects of Bexsero?
Dosage for Bexsero
Two doses (0.5 mL each) of Bexsero should be administered at least 1 month apart.
What Drugs, Substances, or Supplements Interact with Bexsero?
Bexsero During Pregnancy and Breastfeeding
During pregnancy, Bexsero should be administered only if prescribed. There is a pregnancy registry available for Bexsero. It is unknown if Bexsero passes into breast milk. Consult your doctor before breastfeeding.
Our Bexsero (Meningococcal Group B Vaccine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Keep track of all side effects you have. If you need a booster dose, you will need to tell the vaccination provider if the previous shot caused any side effects.
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.
Becoming infected with meningococcal disease and developing meningitis is much more dangerous to your health than receiving this vaccine. Any vaccine may cause side effects but the risk of serious side effects is low.
You may feel faint after receiving this vaccine. Some people have had seizure-like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.
Common side effects may include:
- feeling tired;
- muscle or joint pain;
- nausea, diarrhea; or
- pain, redness, swelling, or a hard lump where the shot was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
Read the entire detailed patient monograph for Bexsero (Meningococcal Group B Vaccine)
The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%).
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
In four clinical trials, 3,058 individuals aged 10 through 25 years received at least one dose of BEXSERO, 1,436 participants received only BEXSERO, 2,089 received only placebo or a control vaccine, and 1,622 participants received a mixed regimen (placebo or control vaccine and BEXSERO).
In a randomized controlled study1 conducted in U.S. and Poland, 120 participants aged 10 through 25 years received at least one dose of BEXSERO, including 112 participants who received 2 doses of BEXSERO 2 months apart; 97 participants received saline placebo followed by MENVEO [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine]. Across groups, median age was 13 years, males comprised 49%, and 60% were white; 34% were Hispanic, 4% were black, <1% were Asian, and 2% were other.
In a second randomized controlled study2 conducted in Chile, all subjects (N = 1,622) aged 11 through 17 years received at least one dose of BEXSERO. This study included a subset of 810 subjects who received 2 doses of BEXSERO 1 or 2 months apart. A control group of 128 subjects received at least 1 dose of placebo containing aluminum hydroxide. A subgroup of 128 subjects received 2 doses of BEXSERO 6 months apart. In this study, median age was 14 years, males comprised 44%, and 99% were Hispanic.
In a third randomized controlled study3 conducted in the United Kingdom (U.K.), 974 university students aged 18 through 24 years received at least 1 dose of BEXSERO, including 932 subjects who received 2 doses of BEXSERO 1 month apart. Comparator groups received 1 dose of MENVEO followed by 1 dose of placebo containing aluminum hydroxide (n = 956) or 2 doses of IXIARO (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) (n = 947). Across groups, median age was 20 years, males comprised 46%, and 88% were white, 5% were Asian, 2% were black, <1% were Hispanic, and 4% were other.
In an uncontrolled study4 conducted in Canada and Australia, 342 participants aged 11 through 17 years received at least 1 dose of BEXSERO, including 338 participants who received 2 doses of BEXSERO 1 month apart. The median age was 13 years, males comprised 55%, and 80% were white, 10% were Asian, 4% were Native American/Alaskan, and 4% were other.
Local and systemic reactogenicity data were solicited from all participants in the studies conducted in Chile, U.S./Poland, Canada/Australia, and in a subset of participants in the U.K. study. Reports of unsolicited adverse events occurring within the first 7 days after each vaccination were collected in all studies. In the U.S./Poland study, reports of unsolicited adverse events were collected up to one month after the second vaccination.
Reports of all serious adverse events, medically attended adverse events, and adverse events leading to premature withdrawal were collected throughout the study period for the studies conducted in Chile (12 months), U.K. (12 months), U.S./Poland (8 months), and Canada/Australia (2 months).
Solicited Adverse Reactions
The reported rates of local and systemic reactions among participants aged 10 through 25 years following each dose of BEXSERO administered 2 months apart or control in the U.S./Polish study1 are presented in Table 1.
Table 1: Percentage of U.S. and Polish Participants
Aged 10 through 25 Years Reporting Solicited Local and Systemic Adverse
Reactions within 7 Days after BEXSERO or Control, by Dose
|Solicited Reactiona||Dose 1||Dose 2b|
n = 110-114
n = 94-96
n = 107-109
n = 90-92
|Local Adverse Reactions|
|Pain||Any Mild Moderate Severe||90||27||83||43|
|Erythema||Any 1-25 mm >25-50 mm >50-100 mm >100 mm||50||13||45||26|
|Induration||Any 1-25 mm >25-50 mm >50-100 mm >100 mm||32||10||28||23|
|Systemic Adverse Reactions|
|Clinicaltrials.gov Identifier NCT01272180.
a Erythema and induration: Any (≥1 mm). Pain and systemic reactions: mild (transient with no limitation in normal daily activity); moderate (some limitation in normal daily activity); severe (unable to perform normal daily activity).
b Administered 2 months after Dose 1.
Solicited adverse reaction rates were similar among participants aged 11 through 24 years who received BEXSERO in the other 3 clinical studies,2,3,4 except for severe myalgia which was reported by 3% to 7% of subjects. Severe pain was reported by 8% of university students in the U.K.3
Non-serious Adverse Events
In the 3 controlled studies1,2,3 (BEXSERO n = 2,221, control n = 2,204), non-serious unsolicited adverse events that occurred within 7 days of any dose were reported by 439 (20%) participants receiving BEXSERO and 197 (9%) control recipients. Unsolicited adverse events that were reported among at least 2% of participants and were more frequently reported in participants receiving BEXSERO than in control recipients were injection site pain, headache, and injection site induration unresolved within 7 days, and nasopharyngitis.
Serious Adverse Events
Overall, in clinical studies, among 3,058 participants aged 10 through 25 years who received at least 1 dose of BEXSERO, 66 (2.1%) participants reported serious adverse events at any time during the study. In the 3 controlled studies1,2,3 (BEXSERO n = 2,716, Control n = 2,078), serious adverse events within 30 days after any dose were reported in 23 (0.8%) participants receiving BEXSERO and 10 (0.5%) control recipients.
Additional Pre-licensure Safety Experience
In response to outbreaks of serogroup B meningococcal disease at 2 universities in the U.S., BEXSERO was administered as a 2-dose series at least 1 month apart. Information on serious adverse events was collected for a period of 30 days after each dose from 15,351 individuals aged 16 through 65 years who received at least 1 dose. Overall 50 individuals (0.3%) reported serious adverse events, including one event considered related to vaccination, a case of anaphylaxis within 30 minutes following vaccination.
Adverse event reports received for BEXSERO marketed outside the U.S. are listed below. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency, or to establish a causal relationship to vaccination. This list includes serious events or events which have suspected causal association to BEXSERO.
General Disorders And Administration Site Conditions
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).
Immune System Disorders
Allergic reactions (including anaphylactic reactions), rash, eye swelling.
Nervous System Disorders
Syncope, vasovagal responses to injection.
Read the entire FDA prescribing information for Bexsero (Meningococcal Group B Vaccine)
© Bexsero Patient Information is supplied by Cerner Multum, Inc. and Bexsero Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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